Pfizer

Eyes, mouth & ears symptom reports

Female, 26 - 39 years

Age Reported Symptoms Notes
26 2021-01-04 loss of smell, loss of taste headache, low grade fever,runny nose, loss taste and smell, feels flushed
26 2021-01-04 ear pain, dry eye, drooling The night after the covid vaccine, the patient started experiencing left-side facial numbness and ti... Read more
The night after the covid vaccine, the patient started experiencing left-side facial numbness and tingling of the V2 and V3. Patient also started experiencing ear pain. Patient also had uncontrollable drooling and dry eye. The next day, the patient went to work and there the adverse events started worsening. Patient went to the ER and did a full workup. CT scan to rule out stroke and full blood work. As per the neurologist (MD), patient is developing mild Bell's Palsy. No course of treatment was given.
26 2021-01-04 lip swelling, lip redness Lip swelling and redness; Lip swelling and redness; This is a spontaneous report from a contactable ... Read more
Lip swelling and redness; Lip swelling and redness; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (nor pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (right arm) on 21Dec2020 (10:45) at single dose for COVID-19 immunization. The patient's medical history included asthma. Concomitant medication included montelukast sodium (SINGULAIR) cetirizine hydrochloride (ZYRTEC) and acetazolamide sodium (DIAMOX), received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced lip swelling and redness on 24Dec2020 (04:00 AM). The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was advised to continue Singulair and given Benadryl and ointment as treatment for the adverse events. The outcome of events was unknown. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. Information about lot/batch number has been requested.
26 2021-01-04 lip swelling headache; fever; severe swelling in her lips; This is a spontaneous report from a contactable other ... Read more
headache; fever; severe swelling in her lips; This is a spontaneous report from a contactable other healthcare professional. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration from 23Dec2020 16:30 at single dose for COVID-19 immunization. The patient's medical history included Crohn's disease. Concomitant medications included paroxetine hydrochloride (PAXIL) and spironolactone. The patient previously took morphine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient was injected with hyaluronic acid lip filler 10 days prior to her vaccine. The patient developed severe swelling in her lips a few hours after she received the vaccine on 23Dec2020. The following day after her vaccine she developed headache and fever too (24Dec2020). The patient went to the Emergency room/department or urgent care and was treated with Benadryl. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. Information about lot/batch number has been requested.
26 2021-01-05 lip swelling As per the patient, her lips were swollen the night and the morning after the vaccine. I as the vac... Read more
As per the patient, her lips were swollen the night and the morning after the vaccine. I as the vaccinator did not witness this reaction when patient was asked to stay 15mins for monitoring post vaccine
26 2021-01-05 lip swelling Went to the ER on the 31st, my face swelled and chest was covered in hives. Lips swelled. I would ge... Read more
Went to the ER on the 31st, my face swelled and chest was covered in hives. Lips swelled. I would get nauseated and I felt like there was acid in my stomach. I also had a headache. I have been taking Zyrtec, Benadryl as needed.
26 2021-01-06 sensitivity to light, extreme sound sensitivity Temporal thermometer reading got up to 105 F, brought down to 102.9 with Tylenol(1,000 mg taken) alo... Read more
Temporal thermometer reading got up to 105 F, brought down to 102.9 with Tylenol(1,000 mg taken) along with tepid bath and pushing cool oral fluids, headache lasting throughout day making sensitivity to light and noise without being dizzy. ibuprofen taking q6 to help with headache.
26 2021-01-06 light flashes or floaters in the eye Skin hurting Restlessness Fever Headache Shortness of breath Seeing flashes Malaise Muscle aches
26 2021-01-07 loss of smell, loss of taste About ten hours after the injection, started having severe chills, N/V, severe headache, dizziness, ... Read more
About ten hours after the injection, started having severe chills, N/V, severe headache, dizziness, fever, severe muscle soreness, active loss of smell and taste. General malaise and weakness.
26 2021-01-07 bloodshot eyes, lacrimation increased Red blood vessels in eyes, worse in left eye; watery eyes; This is a spontaneous report from a non-c... Read more
Red blood vessels in eyes, worse in left eye; watery eyes; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), via an unspecified route of administration in the right arm on 29Dec2020 08:15 at a single dose for COVID-19 immunization. The patient's medical history included mild von willebrand's, situational anxiety, allergies to penicillin, and Visian ICL surgery in August. The patient was not pregnant. Concomitant medications included calcium carbonate, famotidine, magnesium hydroxide (PEPCID COMPLETE), ethinylestradiol, etonogestrel (NUVARING), fexofenadine hydrochloride (ALLEGRA), and hydroxyzine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 31Dec2020 07:00, the patient experienced red blood vessels in eyes, worse in left eye. She also had watery eyes. No pain. No treatment was received for the adverse events. Outcome of the events was recovered with sequel. The events were considered non-serious. No follow-up attempts are possible. No further information is expected.
26 2021-01-07 tongue itchiness ITCHING OF TONGUE AND THROAT; REDNESS OF SKIN ON NECK AND SHOULDERS
26 2021-01-10 mouth numbness Patient reported perioral numbness which progressed over 24 hours to include difficulty breathing. P... Read more
Patient reported perioral numbness which progressed over 24 hours to include difficulty breathing. Patient was transported to the nearest Emergency room for further evaluation/monitoring. Patient was given Benadryl 25mg by mouth x1 dose
26 2021-01-10 swollen tongue Approximately 15 min after vaccination began to experience tingling sensation under tongue. It was n... Read more
Approximately 15 min after vaccination began to experience tingling sensation under tongue. It was not bothersome so I proceeded to go home. At 2:04 pm, approximately 40 minutes after vaccination was driving home and began to experience an elevated HR, shortness of breath/difficulty breathing and throat tightness. Proceeded to pull over to a gas station and felt extremely weak when trying to walk and a tingling sensation all over. Took 25 mg of Benadryl tablets and symptoms began to subside within about 10 minutes or so. Proceeded to continue driving home and had another episode at 2:49 pm, experienced significant shortness of breath and tingling sensation in mouth spread to back of tongue and it felt swollen. I bought liquid Benadryl instead and took ~20 mL. This episode resolved within 10-20 minutes as well and was okay for the rest of the evening.
26 2021-01-11 ear discomfort Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right side of face n... Read more
Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right ear feeling blocked 2 weeks post vaccine; This is a spontaneous report from a contactable nurse. A 26-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EH9899; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 at a single dose for covid-19 vaccination. Medical history included migraine. The patient has no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received her most recent COVID-19 vaccine in a hospital. The patient had right sided face numb/tingling with no drooping or asymmetry and right ear feeling blocked 2 weeks post vaccine (30Dec2020). The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the adverse event. The adverse event result in emergency room/department or urgent care. The event was considered as non-serious. The outcome of the events was recovering.
26 2021-01-12 loss of taste, loss of smell congestion, loss of taste smell and low grade temp, COVID positive
26 2021-01-12 eye floaters Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, swea... Read more
Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, sweating and was flushed. After 15 minutes the dizziness did not go away and my vitals were checked. My BP was elevated 136/106 and HR 105, I was taken to the ED after repeated BP readings continued to show increased diastolic pressure. I was observed in ED for a period of almost 6 hours. Within an 1.5 hours after receiving vaccine, I had right neck stiffness, headache, and some weakness to the right side as well along with the dizziness and high BP. I received a 1L bolus of NS, 2 doses of antivert, Toradol, Zofran and Lidocaine patches. 24 hours after receiving vaccines, I was having pain at the insertion site, headache, neck stiffness and occasional dizziness. After 36 hours my symptoms subsided and I felt back to baseline. Vaccine Dose 2 01/07/2020: I received my second dose of the COVID vaccine and within the first 15 minutes I experienced dizziness, nausea, flashing spots in vision, right sided weakness, increased BP & HR, redness and sweating. After 30 minutes the symptoms did not subsided and I was taken to the ED. An hour after receiving the vaccine, I had right sided weakness to arm and legs with no numbness, dizziness, R. sided neck stiffness, right sided headache, nausea and flashing spots. I received Ativan, Reglan, Tylenol, Toradol and Benadryl in the ED. I was in ED for 3.5 hours after vaccines was administered and was able to ambulate to the car independently. 16 hours after receiving vaccine, I had muscle weakness to bilateral lower extremities and was unable to ambulate independently along with dizziness, headache, arm soreness, cough, congestion, neck stiffness and fatigue. 36 hours after vaccine I regained movement to bilateral lower extremities however still was experiencing fatigue, occasional dizziness, intermittent neck stiffness and headache, body aches and some shakiness to lower extremities. 55 hours after receiving vaccine I was still fatigued and experiencing intermittent headache and neck stiffness. 72 hours after vaccine I was still fatigued and having occasional headaches but feeling much much better from initial reaction. 96 hours after receiving vaccine I experienced occasional headache, woke up with neck stiffness and was finally able to drive a car without any dizziness or nausea. 144 hours after vaccine I am not completely back to baseline still fatigued with occasional neck stiffness and headache but able to go back to work.
26 2021-01-13 ear discomfort swollen lymph nodes; feeling of fullness in ears; This is a spontaneous report from a contactable nu... Read more
swollen lymph nodes; feeling of fullness in ears; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899 and expiry date unknown) intramuscular at the right arm on 21Dec2020 14:30 at single dose for Covid-19 immunization in a hospital. The patient's medical history was not reported. The patient has no COVID prior vaccination. Concomitant medication included paracetamol (TYLENOL), ibuprofen, famotidine (PEPCID [FAMOTIDINE]) and ethinylestradiol, norgestimate (TRI FEMYNOR); all from unspecified date for unspecified indication. The patient has no other vaccine in four weeks. On 21Dec2020 15:45, the patient experienced swollen lymph nodes and feeling of fullness in ears. The patient was not COVID tested post vaccination. The patient did not received treatment for the events. The outcome of the events swollen lymph nodes and feeling of fullness in ears was recovering. The reporter considered the event non-serious; which did not result in death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect.
26 2021-01-13 mouth tingling, lip swelling Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observa... Read more
Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At 1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing and feeling hot, and severe pruritus, especially on the scalp. 50 mg IM Benadryl administered and was taken to ED via wheelchair which is 7 minutes away. Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression on monitor.
26 2021-01-13 mouth tingling 10 ' after vaccine, developed roof mouth tingling , dizziness , tachycardia and Left arm tingling .
26 2021-01-13 mouth tingling Tongue tingling, no other sx : treated with PO Benadryl, sx resolved. Observed 30' : no sequala
26 2021-01-13 feeling of choking 15' after vaccine, developed " tingling in throat" and felt anxious : transferred to ED for E &M. sx... Read more
15' after vaccine, developed " tingling in throat" and felt anxious : transferred to ED for E &M. sx resolved upon arrival, observed for 3 hrs and left AMA
26 2021-01-13 ringing in ears, vision blurred About 16 hours after second dose of the Pfizer COVID-19 vaccination: - Fever of 101-102F - Chills - ... Read more
About 16 hours after second dose of the Pfizer COVID-19 vaccination: - Fever of 101-102F - Chills - Body aches - Joint aches - Headache About 40 hours after time of vaccine: - Fainting spells x2 (shakiness, blurry vision, ringing in ears, loss of balance)
26 2021-01-14 loss of smell Symptoms starts 9am with headache. For 3 times panadol q 4 hours 500mg. At 8pm start fever (40.2 C)... Read more
Symptoms starts 9am with headache. For 3 times panadol q 4 hours 500mg. At 8pm start fever (40.2 C), nauseas, dizzines, shaking chills and lost smell. Vomiting starts at 9:25 pm end 2:00 am. 01/08/2021 at 2:26 am visit Emergency Room, in clinic fainted and present high blood pressure 155/99. In hospital medication administred: Zofran, pepcid, .45 NSS and Phenergan IM at 01-08-2021.
26 2021-01-14 ear pain 12 hours after administration, woken up from sleep by tingling, throbbing in lower legs. Described a... Read more
12 hours after administration, woken up from sleep by tingling, throbbing in lower legs. Described as a nerve and muscle ache/throb, or "growing pains"/RLS symptoms. Put on compression socks which helped, but still too uncomfortable to sleep. Was able to sleep after taking ibuprofen 800mg and drinking water. 6 hours after the ibuprofen was administered, pain returned in lower legs as well as neck/ears with body temperature swings (cold, teeth chattering to sweating uncontrollably in a few minutes). After 1 hour of trying to sleep but failing, put compression socks back on. Temperature rose to 100-100.2 F, chills causing whole body to shake under multiple blankets. Tingling/muscle pains extremely uncomfortable and unable to rest, took another ibuprofen 800mg and water and was able to sleep. Tingling and muscle pains have continued as soon as ibuprofen wears off and come back more intense each time, most notably in the lower legs and near ears/neck and elbow of arm administered in (similar to "tennis elbow," assumed to be provoked by inflammation, happened with first dose).
26 2021-01-17 mouth tingling, swollen tongue I started to notice some itching on my arms and chest and behind my ear so I went to the bathroom t... Read more
I started to notice some itching on my arms and chest and behind my ear so I went to the bathroom to check it out and I noticed the right side of my face was getting red and blotchy looking. I went to talk to the doctor and while I was conversing with her my tongue started to get tingly and started to swell. I took 50mg of benedryl and kept an eye on my symptoms and the tongue swelling started going down but the rash is still there.
26 2021-01-18 eye swelling, lacrimation increased Approximately 4 days after my second dose of Pfizer vaccine, I started noticing my left eye being sw... Read more
Approximately 4 days after my second dose of Pfizer vaccine, I started noticing my left eye being swollen and constantly watering. 7 days post vaccine, I started having left sided facial weakness and droop. I was diagnosed with Bell's palsy by my Primary Care Physician today (8 days post vaccine).
26 2021-01-18 mouth tingling Patient returned to vaccine center approximately 30 minutes after being discharged(initially waited ... Read more
Patient returned to vaccine center approximately 30 minutes after being discharged(initially waited 15min with no symptoms)-upon return patient c/o initial tingling to lips and then itching across face. Treated with 25mg Benadryl, monitored for 40 min. Vital signs remained stable and patient stated that she felt better upon leaving the center.
26 2021-01-19 loss of smell, loss of taste I lost my sense of smell and taste 3 days after receiving the vaccine. no other symptoms
26 2021-01-19 ear pain Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills. Jan 12th- Fatigue, sor... Read more
Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills. Jan 12th- Fatigue, soreness at injection site, and chills. Jan 13th- chills and fatigue. Jan 16th- febrile, body aches, and chills Jan 17th- febrile, fatigue, body aches and chills. Jan 18th- febrile, fatigue, body aches and chills Jan 19th- febrile, fatigue, body aches, chills, sore throat, left ear pain and nausea. Jan 20th- sore throat, body aches, fatigue, hives
26 2021-01-19 oropharyngeal discomfort Started with nausea, racing heart, and dizziness. Within a few minutes scratchy throat and Epi was ... Read more
Started with nausea, racing heart, and dizziness. Within a few minutes scratchy throat and Epi was administered along with O2 at that time. Sent to ER.
26 2021-01-19 lockjaw My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second ... Read more
My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second dose I woke up the next morning feeling very fatigued; dry cough; dizziness/slight dizziness; an aching headache that felt heavy (4/10 pain)/slight headache (2/10 pain); muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; This is a spontaneous report from a contactable healthcare professional (patient). This 26-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) on 08Jan2021 at 16:45, in left arm, for COVID-19 immunization. Medical history included GERD, IBS, gastritis, asthma, anxiety/depression. The patient had known allergies to penicillin, cefalexin monohydrate (KEFLEX), lactose. The first dose of BNT162B2 vaccine (lot EH 9899) was given on 18Dec2020 at 16:00, in left arm and the patient experienced a sore throat for 3 hours, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain). No other vaccine was given in 4 weeks. Concomitant medications included albuterol, pantoprazole, fluoxetine, cholestyramine. After the second dose of vaccine, the patient woke up on 09Jan2021 at 06:30 feeling very fatigued with a dry cough, dizziness, an aching headache that felt heavy (4/10 pain). Later in the day she started having muscle spasms in her hips, knees, shoulders and jaw (7/10 pain). These spasms felt like someone was stabbing her with an electric knife. Over the day the spasms settled into her right hip and knee. Paracetamol (TYLENOL) helped managing the pain and sleep helped the pain getting better. On 10Jan2021 the patient woke up with a slight headache (2/10 pain) and slight dizziness. Her hip felt sore and achy, but she only felt slight spasms when she put weight on it. The events were resolving at the time of report.
26 2021-01-20 tunnel vision Pfizer COVID Vaccine; ADR developed after 5 min. Patient became lightheaded and developed tunnel vi... Read more
Pfizer COVID Vaccine; ADR developed after 5 min. Patient became lightheaded and developed tunnel vision. Had a witnessed syncopal event in her car. Unconcious x1 min, had urinary incontinence, and vomited; Not postictal; developed episode of tunnel vision few hours after 1st dose as well
26 2021-01-21 eye swelling Patient received vaccine and left the clinic. The patient saw the charge nurse approx 45 mins to 1 h... Read more
Patient received vaccine and left the clinic. The patient saw the charge nurse approx 45 mins to 1 hour later while the charge was eating lunch on plaza and c/o of face swelling/feeling flushed. RN walked patient to ER. In the ED, pt reports bilateral eye swelling, facial redness, scratchy throat. Pt initially felt SOB but breathing ok now. No tongue swelling.
26 2021-01-21 mouth numbness 26 y/o woman w/ no sig pmhx, c/o left sided facial numbness/tingling s/o covid vaccine. Pt states sh... Read more
26 y/o woman w/ no sig pmhx, c/o left sided facial numbness/tingling s/o covid vaccine. Pt states she received her vaccine at 3pm, approx 1-2 hrs later started to notice left sided lip numbness that radiated to her left ear and left side of head. No difficulty speaking, no facial heaviness, no changes in vision or hearing. No n/v, no fevers. No previous similar episodes. ED states low suspicion for any stroke, states may be an early bell's palsy vs a pre-rash zoster. Unlikely to be reaction to vaccine. Some slight improvement during ED stay.
26 2021-01-22 mouth tingling Received the Covid-19 vaccine. She reports symptoms of throat tightness externally and tingling tong... Read more
Received the Covid-19 vaccine. She reports symptoms of throat tightness externally and tingling tongue. Patient denied sudden warm feeling, hives, itching, swollen lips/tongue, dyspnea, wheezing, dizziness, tachycardia, crampy, abdominal pain and vomiting. I have observed only what was reported by the patient. Treatment/intervention: patient was given water and a hard candy to suck on. After sucking on the hard candy she stated that helped with her symptoms. Pt was monitored for 30 minutes and stated she felt better with no symptoms before leaving. Informed what to do in case of a severe allergic reaction. Pt was asked if she would like to go to the ED and pt denied.
26 2021-01-23 mouth tingling Probably 5 minutes after receiving the vaccine I started noticing that my right side of my face was ... Read more
Probably 5 minutes after receiving the vaccine I started noticing that my right side of my face was numb. Over time the numbness faded into tingly ness (like after getting a numbing shot at the dentist). It was only the right side of my face and focused around my corner of my mouth and along my jawbone. Over time the feeling subsided probably an hour. While being observed at the clinic they did not notice signs of Bells palsy( facial muscles were still responding symmetrically). Had not sign of allergic reaction at the injection site.
26 2021-01-25 loss of taste, loss of smell Loss of taste and smell
26 2021-01-25 smell distorsion 2 days after I got the COVID vaccine, I began smelling cigarette smoke without there being any smok... Read more
2 days after I got the COVID vaccine, I began smelling cigarette smoke without there being any smoke around me. It has been nonstop and is very distressing.
26 2021-01-25 swollen tongue Patient complained of throat itching and swelling, along with tongue swelling a few minutes after th... Read more
Patient complained of throat itching and swelling, along with tongue swelling a few minutes after the vaccination. Took 2 doses of 0.3 Epi at clinic and with EMS. Patient transported to ER. Upon arrival, symptoms resolved and patient had no other co's or distress with V/S being stable. Patient given prednisone, diphenhydramine and famotidine orally as a precaution, and discharged from the ER.
26 2021-01-25 swollen tongue Itchy throat, swollen tongue, difficulty breathing. Approximately 17 minutes following injection, la... Read more
Itchy throat, swollen tongue, difficulty breathing. Approximately 17 minutes following injection, lasted longer than an hour following epi injection.
26 2021-01-26 vision blurred, visual impairment After receiving the second dose of the covid 19 vaccine, as I was walking to the elevator, my vision... Read more
After receiving the second dose of the covid 19 vaccine, as I was walking to the elevator, my vision started to become blurred and I began to see stars. I walked over to a nearby chair and as I sat down it felt as if my throat was closing. I began sweating profusely and my whole body was flushed. My heart rate was tachycardic and my blood pressure was hypertensive when checked in the ED. When I got to the ED, my vitals were obtained like I described but my heart rate had slowed down by time I got there. A nurse passing by explained that my heart was tachycardia when he assessed me in the chair. The ED did an EKG of my heart that determined my heart rate was normal sinus rhythm in the 70s. They observed me for roughly an hour and let me go home. My discharge papers explain I had a vagal response.
26 2021-01-27 mouth tingling, mouth numbness, lip swelling lip swelling/tingling/numbness, tongue numbness, tightness in throat, tightness in chest Symptoms st... Read more
lip swelling/tingling/numbness, tongue numbness, tightness in throat, tightness in chest Symptoms started around 5-10 mins after the injection in the initial 15 min observation. Was observed for additional 15-20 mins, on-site nurse took vitals. Blood pressure was a little high, heart rate a little escalated, but oxygen saturation 99%. After the total 45-60 mins, symptoms did not lessen, but did not get much worse. Opted to take Benadryl tablet over epinephrine. Patient found some relief of symptoms from the Benadryl.
26 2021-01-28 swollen tongue Slight swelling of tongue (sensation that tongue is suddenly too big for mouth) about 20 minutes fol... Read more
Slight swelling of tongue (sensation that tongue is suddenly too big for mouth) about 20 minutes following the shot and continuing over the next 22 hours and currently.
26 2021-01-28 ringing in ears, tunnel vision Vomiting for 6 hours, severe nausea, high fever (103 first time, 102.6 second time) ringing in ears,... Read more
Vomiting for 6 hours, severe nausea, high fever (103 first time, 102.6 second time) ringing in ears, tunnel vision.
26 2021-01-28 vision blurred Fatigue for 2 and half days. Increased blurred vision while driving and watching television. Tender... Read more
Fatigue for 2 and half days. Increased blurred vision while driving and watching television. Tender at injection site.
26 2021-01-29 lip swelling I received Botox injections on 1/21/21 to both jaw muscles. On the evening of 1/29/21, the left side... Read more
I received Botox injections on 1/21/21 to both jaw muscles. On the evening of 1/29/21, the left side of my face became swollen and felt tingly, numb, and painful. My lips also became swollen when I woke up the morning of 1/30/21.
26 2021-01-31 pain in jaw Right jaw pain below the ear, constant and progressing, Increased soreness with swallowing or spitti... Read more
Right jaw pain below the ear, constant and progressing, Increased soreness with swallowing or spitting.
26 2021-02-02 swelling of eyelid Patient experienced upper eyelid swelling and throat tightness
26 2021-02-02 tunnel vision 15mins after the injection " reported feeling faint and stated her vision began tunneling" BP 86/55... Read more
15mins after the injection " reported feeling faint and stated her vision began tunneling" BP 86/55 temp 98.2 O2 sat 97% HR 63 Lay down with water and snack 10 min after 105/72 5min 112/78 , denied feeling lightheaded, dizzy or any other symptoms when she left .stated almost fainting in the past from injections"
26 2021-02-07 mouth itchiness, lip swelling pt experienced lip swelling and mouth itching, she was given 25mg of Benadryl PO and the symptoms re... Read more
pt experienced lip swelling and mouth itching, she was given 25mg of Benadryl PO and the symptoms resolved within 60 minutes
26 2021-02-07 mouth tingling, visual impairment mental confusion; inability to speak/tried to say things and it was a jumbled, meaningless string of... Read more
mental confusion; inability to speak/tried to say things and it was a jumbled, meaningless string of words; felt very cold; tingling around the mouth; aura like a bad migraine; bright spotty vision in the peripheral right field; bright spotty vision in the peripheral right field; thought she was having a stroke; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; likely a severe migraine; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231, expiration date was unknown), intramuscularly on the left arm on 30Dec2020 at 14:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. Relevant medical history included COVID-19, which was diagnosed prior to vaccination and migraines (before). The patient had no allergies to medications, food, or other products. Concomitant medication included melatonin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 15:45 or 1 hour after the vaccine injection, the patient had an aura like a bad migraine and she had bright spotty vision in the peripheral right field for 15-20 minutes; the patient has had migraines before, but they're not common for her. Two hours after the vaccine, on 30Dec2020 at 16:45, the patient had mental confusion and an inability to speak; she tried to say things to her husband and it was a jumbled, meaningless string of words. She also felt very cold and she had tingling around the mouth. Her husband thought she was having a stroke and called 911 on 30Dec2020. All her vitals were stable, and within 10 minutes she could speak again. On 30Dec2020, the patient's electrocardiogram (EKG) showed peaked T waves, common with dehydration and high potassium. She was encouraged to go to the emergency room (ER). Instead of taking the ambulance, she drove herself several hours later. The patient wanted someone to tell her it wasn't a stroke. After a brief neurological exam on 30Dec2020, the doctor said it was likely a severe migraine and wrote the reason for her visit as a vaccine reaction. This took place in the late evening to early morning, and she missed one day of work. The events did result in an emergency room/department or urgent care visit. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered from all the events on 31Dec2020.; Sender's Comments: Based on the close temporal relationship, the association between the event stroke with BNt162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
26 2021-02-08 ear pain These symptoms started the evening of my vaccine and lasted for 4 days (1/28/2021 through 1/31/2021)... Read more
These symptoms started the evening of my vaccine and lasted for 4 days (1/28/2021 through 1/31/2021). Uncontrollable chills, severe body aches, upper/middle back pain, neck pain/stiffness, extreme fatigue, ear aches, raging frontal and occipital headache, and hives (white in color on both legs - inner knee area), itchy neck and chest. Benadryl taken for hives. Ibuprofen taken for other side effects. No treatment/OTC medication provided real relief until late evening of day 3 after vaccine. Hives and side effects resolved entirely after 4-5 days post-vaccine. White hives turned into red healing rash-like bumps and eventually disappeared entirely.
26 2021-02-08 teeth hypersensitivity Severe chills, fevers up to 102 F for 24 hours after, nausea, one episode of emesis, fatigue, and bo... Read more
Severe chills, fevers up to 102 F for 24 hours after, nausea, one episode of emesis, fatigue, and body aches. These lasted for approximately 2 days following the vaccine. Mild cramping similar to menstrual cramping 2-3 days following initial symptoms, no bleeding. Mild teeth sensitivity for 2-3 days about the same time frame as uterine cramping.
26 2021-02-11 lip swelling, lip redness Hives on lips - tiny red bumps on outer edge of top and bottom lips, swollen lips - both top and bot... Read more
Hives on lips - tiny red bumps on outer edge of top and bottom lips, swollen lips - both top and bottom, both lips bright red
26 2021-02-11 sensitivity to light, vision blurred Persistent migraine. My headache began about 3 hours after and stayed mild until about 30 hours late... Read more
Persistent migraine. My headache began about 3 hours after and stayed mild until about 30 hours later where it grew to a migraine. It is not day 8 since the vaccine and it has not gone away. In addition to the migraine I am experiencing light sensitivity, blurred vision, and yesterday I experienced some heart palpitations. I went to urgent care on 2/8 and was prescribed IC Butalb-Acetamin-Caff for the migraine symptom. In addition I have been taking tylenol and advil which are not helping. My injection site pain and brain fog have resolved while the headache has persisted.
26 2021-02-19 mouth numbness, lip swelling, eye swelling I visited Hospital after noticing a reaction to the covid shot. The left side of my face including m... Read more
I visited Hospital after noticing a reaction to the covid shot. The left side of my face including my eye, cheek and lips felt swollen and numb. I also had the chills. The doctor was unable to give me any information related to my reaction from the vaccine and recommended I take Tylenol. However this reaction persisted for the past four days. The swelling has subsided.
26 2021-02-19 visual impairment, swelling of eyelid Dizziness described as a swaying sensation. Swollen eyelid. Dizziness/sway has not gone away. Also o... Read more
Dizziness described as a swaying sensation. Swollen eyelid. Dizziness/sway has not gone away. Also off balanced and visual axis is now tilted.
26 2021-02-23 mouth tingling Patient complained of tingly lips, itchy left arm (near vaccine site). Patient waited 30 minutes wi... Read more
Patient complained of tingly lips, itchy left arm (near vaccine site). Patient waited 30 minutes with improvement of symptoms and left the site.
26 2021-02-25 mouth numbness tongue/face numb. Shaky/dizzy while sitting. reported arm pain. Refused ED. Rapid response evalu... Read more
tongue/face numb. Shaky/dizzy while sitting. reported arm pain. Refused ED. Rapid response evaluated. pt ambulated from cafeteria to home
26 2021-02-26 mouth tingling 830am given, 1015am facial numbness and tongue tingling. Slurred speech. Itching and burning sensati... Read more
830am given, 1015am facial numbness and tongue tingling. Slurred speech. Itching and burning sensation internally. Medications to stop allergic reaction given by IV. Discharged home. Slight fever currently, muscle and body aches and pains. Joint pain. Headache.
26 2021-02-28 dry mouth Swollen lymph nodes (left side of neck, under arm, left chest); Dry mouth; This is a spontaneous rep... Read more
Swollen lymph nodes (left side of neck, under arm, left chest); Dry mouth; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL 3247, expiry: unknown), via an unspecified route of administration in the left arm on 27Jan2021 12:45 at a single dose for COVID-19 immunization at a workplace clinic. Medical history included endometriosis, vertigo, pure hypercholesterolemia and allergies to sulfa, orange citrus and almonds. The patient has no covid prior to vaccination. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]), rosuvastatin calcium (CRESTOR), magnesium, ethinylestradiol, norgestimate (SPRINTEC) and multivitamin. The patient had no other vaccine in four weeks. The patient had PCR test via nasal swab on 04Feb2021 which was negative. The patient experienced dry mouth on 27Jan2021at 13:00 and swollen lymph nodes in the left side of neck, under arm, and left chest on 31Jan2021 at 13:00. The events were not treated. The event dry mouth recovered with sequelae on 31Jan2021 while swollen lymph nodes recovered with sequelae on 07Feb2021.
26 2021-02-28 lip swelling, swollen tongue 1 hour after the vaccine shot I began experiencing allergic symptoms including intense drowsiness, t... Read more
1 hour after the vaccine shot I began experiencing allergic symptoms including intense drowsiness, throat scratching, coughing, lip and tongue swelling. I took a Zyrtec and the symptoms began improving. They did not fully go away until 4 hours later.
26 2021-03-02 vision blurred 15 minutes after receipt of dose #1 patient developed blurred vision and dizziness. I arrived to th... Read more
15 minutes after receipt of dose #1 patient developed blurred vision and dizziness. I arrived to the patient's side and conducting an abbreviated history as well as a neuro exam. Patient had new onset tremor in upper extremities, positive Romberg, and ataxia. HR ranged from 130-140 w/ SPO2 at 99. No signs of difficulty breathing noted. 911 was called and an ambulance was dispatched. Patient's symptoms remained unchanged upon EMS arrival and she was evacuated to a healthcare facility.
26 2021-03-03 pain in jaw The night I got my first Covid vaccine, the left side of my face started to tingle and my jaw began ... Read more
The night I got my first Covid vaccine, the left side of my face started to tingle and my jaw began to hurt. I took Tylenol and Ibuprofen, but the pain didn't subside. I made a doctor's appointment on 2/25/21, which is when I was diagnosed with Bells Palsy.
26 2021-03-04 lip swelling Within 10 minutes of receiving the vaccine I had a flushed/hot/sun burned looking face. Within 15 mi... Read more
Within 10 minutes of receiving the vaccine I had a flushed/hot/sun burned looking face. Within 15 minutes I had hives on my chest in back. I had high blood pressure 180/120, facial puffiness and mild bottom lip swelling. I developed an onset of increased mucus in my throat causing me to clear my throat frequently. RN on site reported no throat swelling, but increased thickness due to mucus. I received a Benadryl injection on site within 30 minutes and almost immediately symptoms began to lessen. The next day I had mild bottom lip swelling, body itchiness, chest rash, headache and fatigue. Today (24 hours after vaccine) I have a headache, fatigue and body itchiness.
26 2021-03-08 swollen tongue, eye swelling, mouth swelling Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Fa... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Tachycardia-Mild, Additional Details: patient is able to swallow and drink water .Just complained of sore throat,. Called 911 , assessed patient \"Anxiety Reaction\".\r\n
26 2021-03-09 vision blurred, eye strain At about 7:30 I started feeling extremely weak followed by coughing. Soon after my throat was tighte... Read more
At about 7:30 I started feeling extremely weak followed by coughing. Soon after my throat was tightened and it became difficult for me to breathe. My eyes have been blurry since and I?ve had a fever, cold, and my entire right side of my body hurts when I move especially from my hips down. My eyes are extremely heavy and I feel better with them being closed
26 2021-03-10 thirst Severe chills and shaking, fever, headache, thirst, muscle aches, nausea
26 2021-03-11 mouth tingling Red splotches, itching, tingling in face and lips Given Benadryl
26 2021-03-11 mouth tingling 5:28pm received 1st Covid-19 vaccine. At 5:40 c/o slight throat tightness. O2 sat 99, Pulse 100, B/P... Read more
5:28pm received 1st Covid-19 vaccine. At 5:40 c/o slight throat tightness. O2 sat 99, Pulse 100, B/P 128/80. At 5:45pm c/o tongue tingling. 5:49pm hives on chest and c/o chest tightness. Denies SOB. O2 sat 99, pulse 130, B/P 124/72. 5:50pm 0.5 mg Epi administered IM left thigh and EMS activated. 5:50pm pulse 110, B/P 130/82, O2 sat 98%. Transported to hospital at 6:02pm per ambulance.
26 2021-03-11 tongue itchiness, lip swelling 10 minutes after vaccine lips swelled, itching tongue after 45 minutes. Monitored for 1 hour at hosp... Read more
10 minutes after vaccine lips swelled, itching tongue after 45 minutes. Monitored for 1 hour at hospital then for another 2 hours at home. No medicine was given, but was offered. I have history of anaphylaxis and said I wanted to wait and see if it would resolve without medicine or at least not get worse. So far still I worse, if it would have gotten worse it would have happened already.
26 2021-03-14 blindness approx 2-5 min after getting vaccine, pt felt faint. pt started to lose vision (only seeing black).... Read more
approx 2-5 min after getting vaccine, pt felt faint. pt started to lose vision (only seeing black). pt was seated and seemed to fade in and out, while staying conscious. RPH stayed with pt for following 5-10 minutes and paramedics arrived on scene. Vitals were taken, and after approx. 15 min with paramedics, they deemed her fit. Pt remained in pharmacy another approx. 30 min while she regained her faculties. She had some pain radiating in her arm and was very anxious. after a total of approx. 90 min, she was comfortable and left the pharmacy.
26 2021-03-14 taste impairment Metallic taste in mouth
26 2021-03-16 thirst 14 hours after vaccination: Fever, full body aches, headache, full body tremors, increased thirst Ne... Read more
14 hours after vaccination: Fever, full body aches, headache, full body tremors, increased thirst Next day: low grade fever, sore muscles, headache, increased thirst
26 2021-03-17 mouth tingling Pt had tongue tingling right after the first vaccination and took Benadryl and went better. Prior to... Read more
Pt had tongue tingling right after the first vaccination and took Benadryl and went better. Prior to the next vaccination she took Benadryl and after felt tongue tingling again and dizziness. Pt continued Benadryl until seen by our facility today. Today was given 120mg Solu Medrol IM and had to wait 30 minutes and showed great improvement.
26 2021-03-18 loss of smell, loss of taste, smell distorsion Loss of taste and smell, Parosmia, Fatigue, Pain breathing
26 2021-03-18 eye pain, eye swelling Pain/slight swelling on the left eye later that night of the injection.
26 2021-03-19 taste impairment Pfizer-BioNTech COVID-19 Vaccine EUA Metallic taste immediately following injection lasting 2 days ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Metallic taste immediately following injection lasting 2 days 27 weeks 4 days gestation
26 2021-03-20 dry mouth, thirst Sudden drowsiness, fatigue and headache. Extreme thirst and dry mouth for more than 24 hours.
26 2021-03-22 loss of smell, loss of taste Received COVID vaccine 1/4/2021. On 1/15/2021 developed chills, headache, loss of taste/smell, rhin... Read more
Received COVID vaccine 1/4/2021. On 1/15/2021 developed chills, headache, loss of taste/smell, rhinorrhea, pharyngitis. Tested positive for COVID.
26 2021-03-22 lip swelling, mouth numbness Paralysis on the right side of the face, numbness inside the mouth, swelling of face, lips, throat, ... Read more
Paralysis on the right side of the face, numbness inside the mouth, swelling of face, lips, throat, and neck.
26 2021-03-23 ear discomfort, pain in jaw, sensitivity to light For the last 7 weeks Ive had persistent tension headaches with migraines. In addition, jaw pain, ear... Read more
For the last 7 weeks Ive had persistent tension headaches with migraines. In addition, jaw pain, ear pressure, photophobia. Have gone to the ER, urgent care, and neurology. Have tried various medication with no luck - todarol, Advil, acetominophen, methylpresidone. Notably, at the 6 week mark on 3/18/21 I received a semi quantitative antibody test specific to the spike protein which came back negative. I have previously reported to VAERS but symptoms have continued so I am filling out another form.
26 2021-03-24 lip swelling, taste impairment, lip blister, mouth discomfort, mouth tingling Stayed 30 minutes after vaccine at vaccination clinic to be safe in case of a reaction. About 5 minu... Read more
Stayed 30 minutes after vaccine at vaccination clinic to be safe in case of a reaction. About 5 minutes after leaving 11:30 I could taste the vaccine in my mouth. I immediately felt intense sharp tingling in my lower lip, it felt hot and swollen (upper lip never had a reaction). I instantly felt a lump in my throat and had a hard time swallowing. I started with chest pain that resolved itself in a minute or two. A few minutes later a family member noticed my face was red and flushed and said I looked like I had a sun burn. Swelling in throat resolved within an hour. Lip never visually looked swollen but I could feel the tightness, burning and tingling that resolved within the hour. Redness on face resolved within a couple hours. Had tiny blisters about 3 show up above upper lip I still have them the next day with a couple more but they aren't causing problems. My airway was never blocked I never had a hard time breathing. I did have a sore throat this morning March 25 day after vaccine. All other symptoms seem normal.
26 2021-03-25 visual impairment Vision change 20-30 seconds Nausea/vomiting Lightheaded Sweaty Warm Paresthesia in hands
26 2021-03-27 taste impairment, feeling of choking Less than 3 minutes after administration, I began having tingling in my throat. My heart began to ra... Read more
Less than 3 minutes after administration, I began having tingling in my throat. My heart began to race. I grabbed a medically professional who assessed me, she stated I was beginning to flush and then had EMS respond. Vital signs indicated a peak heart rate in the 160?s, O2 Sats were in the 80?s. I also had a metallic taste in my mouth and a tightness in my airway. Later in my hour observation I had a period of facial flushing and itching. I had ice packs placed on my skin, given a fluid bolus and monitored by an RN and EMS personal. A Doctor assessed me and contemplated transporting to the ED for management but I was slowly feeling improvement. I was monitored for an hour and felt okay when I left the clinic.
26 2021-03-28 lip swelling 3/27: headache, fatigue 3/28: swollen lymph nodes, headache 3/29: itchy rash covering arms and legs ... Read more
3/27: headache, fatigue 3/28: swollen lymph nodes, headache 3/29: itchy rash covering arms and legs with patchy areas on back and stomach; bottom lip swollen
26 2021-03-30 taste impairment metallic taste in mouth occurring immediately after lasting about 24hrs
26 2021-03-30 mouth ulceration lymphadenopathy; Fever; a lot of ulcers in all of the the upper and lower lips, gums, inside the mou... Read more
lymphadenopathy; Fever; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; They are super painful.; I can't even eat and talk. As the days go by, more appear; I can't even eat and talk. As the days go by, more appear; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 07Mar2021 17:30 (Batch/Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. On 08Mar2021 10:00, the patient experienced Fever, lymphadenopathy, a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils. They are super painful. I can't even eat and talk. As the days go by, more appear. Ae resulted in: [Emergency room/department or urgent care]. The patient received treatment for the events. Ae treatment: Acyclovir. Maalox and Benadryl mouth rinses. The outcome of the events was not recovered. Covid test post vaccination: [covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test date=10Mar2021, covid test result=Negative}]
26 2021-03-30 smell distorsion Foul smells, odors. Things smelling completely abnormal
26 2021-03-30 enlarged tonsils Moderate arm pain, burning when trying to tense muscle beginning 4h after vaccine and at worst by be... Read more
Moderate arm pain, burning when trying to tense muscle beginning 4h after vaccine and at worst by bedtime. Palpable fatigue on day of and day after vaccination. Sore throat and swollen tonsils day after vax.
26 2021-03-30 visual impairment Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a ... Read more
Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a contactable Other HCP (Patient). A 26-yearfemale patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 administered in Arm Right on 04Feb2021 17:30 as single dose for covid-19 immunisation. Patient medical history contains allergies to Oats, sulfa containing antibiotics. Concomitant medications were not reported. It was reported that on 05Feb2021 12:30 PM patient experienced migraine and headache for 7 days (still ongoing) visual impairments and pain at injection site. The patient had taken migraine medication. On 08Feb2021 Patient undergone PCR test Covid test post vaccination through Nasal Swab shown a Negative Covid test result negative. On 11Feb2021 Patient undergone PCR test Covid test type post vaccination nasal Swab shown a negative Covid test result. The outcome of the event pain at injection site resolved in 1 day remaining events with outcome of not recovered. The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [24Mar2021], this case now contains serious adverse reaction(s). Information processed together.
26 2021-03-31 mouth numbness 3 days after receiving the Pfizer COVID-19 vaccination, the patient reported numbness in her bilater... Read more
3 days after receiving the Pfizer COVID-19 vaccination, the patient reported numbness in her bilateral toes that progressed to numbness and weakness of her bilateral legs. 5 days after the onset of her initial symptoms, the patient noted bilateral numbness in her fingers and her mouth, that also progressed to weakness in her bilateral arms. A few days later, the patient noticed a right-sided facial droop that brought her to the ED. Given the patient's symptoms and elevated protein in the patient's CSF (obtained via lumbar puncture), the patient's symptoms are concerning for Guillain-Barre syndrome. The patient was started today on 5 days of immune globulin (PRIVIGEN) 10 % IV infusion 25 g.
26 2021-03-31 swollen tongue Patient reported history of tongue swelling after receiving the 1st dose of Pfizer COVID-19 vaccine.... Read more
Patient reported history of tongue swelling after receiving the 1st dose of Pfizer COVID-19 vaccine. Patient consulted MD and MD recommended patient to receive the 2nd dose of vaccine. Patient declined premedication with Cetirizine . Approximately 5 minutes after receiving the vaccine, patient reported swelling in tongue. Patient remained talkative and was able to speak in full sentences. O2 sat decreased to 90%. Patient placed on 02 via nasal canula at 2 lpm. BP 129/72, HR 88, O2 sat 96% on 2 lpm of O2 via nasal canula. Patient Benadryl 50 mg was attempted to be given IM however at least 50 % of the medication leaked out of the injection site. Patient continued to breath comfortable but talked with shortness of breath. 2nd dose of Benadryl 50 mg given IM. Patient continued to be monitored . Patient released home with sister and will be observed at home overnight.
26 2021-04-01 loss of taste, loss of smell Patient received COVID vaccine 12/21/2020 and 1/12/2021. On 3/30/2021 developed cough, loss of tas... Read more
Patient received COVID vaccine 12/21/2020 and 1/12/2021. On 3/30/2021 developed cough, loss of taste/smell, congestion, and rhinorrhea. Tested positive for COVID.
26 2021-04-02 deafness, ringing in ears tinnitus and hearing loss in left ear
26 2021-04-02 thirst 101°F fever (began approximately at 9:00pm 04/02/2021; ongoing as of 4:32am 04/03/2021 ) Chills Mus... Read more
101°F fever (began approximately at 9:00pm 04/02/2021; ongoing as of 4:32am 04/03/2021 ) Chills Muscle and joint pain Swollen lymph nodes in neck and armpit Fatigue Injection site pain Pain while using injected arm Headache Abnormally high thirst Difficulty sleeping
26 2021-04-05 eye swelling I got my first r my first dose of the pfizer vaccine dose at 9 am that morning and around 10 hours l... Read more
I got my first r my first dose of the pfizer vaccine dose at 9 am that morning and around 10 hours later around 8 pm I got hives on the left side of face and hives/ swelling around left eye and my nose was literally dripping mucous like a faucet onto the floor and I started getting a super itchy and tight through. Obviously an allergic reaction, I took two benedryls fell asleep and woke up fine. I am not sure if I should get my second dose tomorrow.
26 2021-04-05 mouth numbness Immediately following injection, patient vomited x 30 minutes. The following morning she had numbnes... Read more
Immediately following injection, patient vomited x 30 minutes. The following morning she had numbness in her lips. On the second day following the injection, she developed left axillary edema which has not resolved.
26 2021-04-07 loss of taste Headache, muscle soreness, joint pain, fever, chills, cold sweats, loss of taste, stuffy nose, dry c... Read more
Headache, muscle soreness, joint pain, fever, chills, cold sweats, loss of taste, stuffy nose, dry cough
26 2021-04-07 ringing in ears, eye movement disorder Less than five minutes of receiving vaccine: Eyes rolling back, feeling of fainting, tinnitus, blue ... Read more
Less than five minutes of receiving vaccine: Eyes rolling back, feeling of fainting, tinnitus, blue lips, blue fingers, really hot, Thirty minutes after receiving the vaccine: bad chills/shakes/shivers/teeth chattering, diarrhea, confusion
26 2021-04-09 mouth tingling, dry throat, dry mouth, mouth numbness When I first got my shot I had a wave of heat go through me and then my throat and moth went dry. I ... Read more
When I first got my shot I had a wave of heat go through me and then my throat and moth went dry. I waited my 15 minutes and get fine. 40 minutes after my shot I developed swollen face, lip, tongue and throat numbness and get like I couldn?t breathe. Then I went to ED. They gave me Benadryl and steroid and eventually sent home. Today 04/10/21 I woke up. Took my Benadryl and prednisone and about and hour after that my face has been extremely red, numb, and burning. It?s been 9 hours and I?m still having these symptoms. Called ED they said to stop the prednisone and only take Benadryl but my face is still really hot, red and burning.
26 2021-04-09 ringing in ears, deafness Ringing in ears started on Thurs around 11am (3/18) after Tuesday at 3:00pm injection (3/16). The ri... Read more
Ringing in ears started on Thurs around 11am (3/18) after Tuesday at 3:00pm injection (3/16). The ringing has been a high pitched frequency that has not changed in volume, tone and is constant. I went to audiologist and they detected notched hearing at 1500hz. I have not had any other symptoms and this has never happened before. The ringing has not stopped and it has been just over 3 weeks.
26 2021-04-09 ringing in ears, visual impairment Systemic: Dizziness / Lightheadness-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturba... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient stated she felt ringing in the ear and darkening of vision within 5 minutes of vaccine administration. Patient felt better after drinking orange juice, and water. Patient was observed for total 30 minutes.
26 2021-04-09 tunnel vision 26-year-old female with past medical history of asthma and anxiety, and syncopal episode after her f... Read more
26-year-old female with past medical history of asthma and anxiety, and syncopal episode after her first Covid vaccination, presents to the emergency department after syncopal episode after her second Covid vaccination. Patient states she received her shot, and about 45 seconds later started feeling similar to the way she felt during the first syncopal episode. She started having tunnel vision, and her mom who is with her this time, notes that she was getting more pale. Mom notes that patient was talking about what she was feeling and was slowing down, until she passed out for about 30 seconds. During her LOC, she was shrugging her shoulders repeatedly, and after she awoke, she returned to her baseline mental status after about a minute or 2. As she was returning to her baseline mental status, she was talking about how she was feeling and it was appropriate. No urinary incontinence or tongue biting. Denies any recent chest pain, shortness of breath, other episodes of lightheadedness or syncope. She is not had syncopal episodes after shots before. After her last injection, she had a syncopal episode and fell flat on her face, thus had a CT head. At the time her CT head is negative, she had a D-dimer that was also negative. Her labs at the time were notable for hypokalemia 3.3, and in preparation for that she states she has been eating a lot of bananas this week. At this time she does not want any lab work, and feels as if this was a similar vasovagal episode similar to last time. syncopal episode right after a COVID vax. Same thing happened with the first dose. Prior to passing out felt sweaty, lightheaded, body tingling then passed out. Didn't fall this time as she was expecting it. Never had fear of needles before. No abd pain, back pain, chest pain. No h/o PE, DVT, OCPs, calf pain, SOB. No cough, SOB, palpit, diaph, chest pain/pressure, headache. No abd pain, no back pain, no vomit, no diar. No urinary complaints. No rash. No numb/weakness. No URI Sx. Mom noted a few shoulder twitches but not GTC type symptoms. rapid response called, pt went to emergency department
26 2021-04-10 eye swelling Left arm sore at injection site Left eye and cheek swelling, redness, and heat Fever of 99.6 degrees... Read more
Left arm sore at injection site Left eye and cheek swelling, redness, and heat Fever of 99.6 degrees Started around 9:00pm on 04/03/2021
26 2021-04-10 tongue blistering Welts on the back of tongue. Swollen papillae. Blister sized lumps. Painless but seem to be increasi... Read more
Welts on the back of tongue. Swollen papillae. Blister sized lumps. Painless but seem to be increasing in size
26 2021-04-11 smell distorsion, loss of smell All food smells and taste horribly. It smells and taste like dirty kitchen. The best way I can descr... Read more
All food smells and taste horribly. It smells and taste like dirty kitchen. The best way I can describe it is a mixture of chlorine, metal and moldy fold. I've also been experiencing nauseous and diarrhea. This all began an hour and a half after receiving the vaccination and has continued since.
26 2021-04-12 dry throat, dry mouth The patient is a 26 year old female who presents to the practice today for a transition into care.Th... Read more
The patient is a 26 year old female who presents to the practice today for a transition into care.The patient is transitioning into care from an emergency room and a summary of care was reviewed. Note for "Transition into care": Patient went to ER 4/9/21 for facial swelling, numbness and feeling like she could not breath and was discharged 4/9/21. Patient states she had the covid vaccine Pfizer 4/9/21 and had reaction after about 40 minutes. Patient states the right side of face started to swell, numbness across her face (lips, tongue, throat) and she felt like she could not breath. Patient was given Benadryl, Pepcid and Decadron. Patient was prescribed for Benadryl and Prednisone. Patient states on 4/10/21 she had a reaction to Prednisone with beet red face, facial warmth, rash, and facial numbness again. Patient states when getting the Hep A vaccine 3/17/21 she felt a wave of heat go over her body and her mouth and throat were super dry and the same thing happened when she got the Pfizer covid vaccine.
26 2021-04-13 blindness Vasovagal syncope after three minutes of receiving first vaccine dose. Paleness, nausea, sweating, d... Read more
Vasovagal syncope after three minutes of receiving first vaccine dose. Paleness, nausea, sweating, dizziness, and vision blackout. Treated by lying down, applying ice packs, and hydrating with water. Symptoms subsided within five minutes.
26 2021-04-13 ear pain On 4/3/21 at roughly 6p.m. the patient stated that she began to experience ear pain. This lasted unt... Read more
On 4/3/21 at roughly 6p.m. the patient stated that she began to experience ear pain. This lasted until 4/11/21 when she woke up in the morning with half of her face feeling numb. She went to the ER and was diagnosed with Bell's Palsy. She was started on a 7 day course of prednisone 60mg daily and Valtrex 1000mg three times daily. She was also given Refresh eye drops. On 4/13/21 she went to her primary doctor who told her to contact the pharmacy.
26 2021-04-13 drooping eyelid I got completely numb on the right side of my face. I called a hotline nurse and she told me it coul... Read more
I got completely numb on the right side of my face. I called a hotline nurse and she told me it could be bells palsy. My eye started to droop. Got worse and then got better. Face still a little numb
26 2021-04-13 mouth tingling tingling tongue, tachycardia, flushing Tx: Vital signs, monitored for 90 min 1/25/ allergy evaluat... Read more
tingling tongue, tachycardia, flushing Tx: Vital signs, monitored for 90 min 1/25/ allergy evaluation -> Recommended hydration administer 2ND dose in reclined position observe for 60 min 1/27 2nd dose c adverse reaction
26 2021-04-15 taste impairment After receiving first COVID vaccine patient reported tasting metal, itchiness in right leg. Patient ... Read more
After receiving first COVID vaccine patient reported tasting metal, itchiness in right leg. Patient was monitored for an additional 10 minutes, no additional symptoms were noted during while being monitored.
26 2021-04-15 vision blurred APPROXIMATELY 12 MINUTES AFTER THE VACCINE WAS GIVEN THE PATIENT STARTED TO COMPLAIN OF FEELING LIGH... Read more
APPROXIMATELY 12 MINUTES AFTER THE VACCINE WAS GIVEN THE PATIENT STARTED TO COMPLAIN OF FEELING LIGHTHEADED AND HAVING BLURRED VISION ALSO ASSOCIATED NAUSEA. SHE WAS BROUGHT BACK TO A STRETCHER AND VITALS WERE TAKEN AND STABLE. SHE SUBSEQUENTLY STARTED TO HAVE SOME DRY HEAVES AND FEELING OF ITCHING IN THROAT WITH PROGRESSION OF HER SYMPTOMS. HER PULSE OX WAS 93-98%, bp 110/82 AND HR 67. iT WAS DECIDED TO ADMINISTER AN EPIPEN AND SHE HAD AN INCREASE OF HR TO 102; AT THIS POINT EMS WAS CALLED. SHE DID START TO DEVELOP THROAT TIGHTNESS, ITCHING, AND COUGH AT WHICH TIME OXYGEN WAS ADMINISTERED. SHE WAS TRANSFERRED TO ER AT THE MEDICAL CENTER FOR FURTHER EVALUATION. REPORT FROM ER NOTES SHE DID HAVE SEIZURE WHILE ENROUTE WHICH WAS TREATED. THE PATIENT WAS KNOWN TO HAVE UNDERLYING SEIZURE DISORDER.
26 2021-04-18 ringing in ears, permanent deafness, ear discomfort sensorineural hearing loss; tinnitus followed by sensation of ear fullness; tinnitus followed by sen... Read more
sensorineural hearing loss; tinnitus followed by sensation of ear fullness; tinnitus followed by sensation of ear fullness; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809 and expiration date not provided) via an unspecified route of administration administered in the left arm on 01Apr2021 10:00 as a single dose for COVID-19 immunization. Medical history included Gilbert syndrome. The patient is not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021, 08:30 for Covid-19 immunization. On 01Apr2021 17:00, the patient experienced 2 hours of tinnitus followed by sensation of ear fullness. She woke up the next day, 02Apr2021 with sensorineural hearing loss for which she was given a course of high dose steroids and requiring follow up with ENT and otoneurologist. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events includes 60 mg prednisone in emergency department and was prescribed 10 days. The outcome of the events was not recovered. The reporter assessed the events as serious (disabling/incapacitating).; Sender's Comments: Based on the close temporal relationship, A possible contributory role of the suspect product to the development of Tinnitus, sensation of ear fullness and Sensory Neural Hearing Loss cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
26 2021-04-18 visual impairment pt has severe fear of needles, reports always gets dizzy on any shot that she has ever had previousl... Read more
pt has severe fear of needles, reports always gets dizzy on any shot that she has ever had previously, after shot administered pt reported more severe dizziness than normal and seeing spots, had pt lay in supine position while call 911, pt seemed breathy but said she was just nervous and denied trouble breathing, EMS arrives, evaluated pt, and the went home on their own after sx resolved without any medical intervention, all vitals fine, pt encouraged to contact PCP, I reached out as well and left message for prescriber
26 2021-04-20 vision blurred arm was starting to go numb/get heavy; tingling/pins and needles type feeling start migrating to and... Read more
arm was starting to go numb/get heavy; tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms; then that my vision started getting blurry; heart rate started elevating to a point where I even had to put my bf's hand on my chest to show him; lightheaded feeling; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself. A 26-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:15 (Batch/Lot Number: EW 0150) as single dose for covid-19 immunisation . Medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. The patient previously took vicodin and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. The patient experienced arm was starting to go numb/get heavy on 08Apr2021 23:45 with outcome of not recovered , tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms on 08Apr2021 23:45 with outcome of not recovered , then that my vision started getting blurry on 08Apr2021 23:45 with outcome of not recovered , heart rate started elevating to a point where i even had to put my bf's hand on my chest to show him on 08Apr2021 23:45 with outcome of not recovered , lightheaded feeling on 08Apr2021 23:45 with outcome of not recovered. All the reported events were considered serious because Important Medical Events. The patient underwent lab tests and procedures which included heart rate: started elevating on 08Apr2021 , sars-cov-2 test: negative on 06Apr2021 (covid test name post vaccination: Sofia SARS Antigen FIA). The patient visited her PCP and a Bloodwork was scheduled. Follow up information has been requested.
26 2021-04-20 visual impairment Migraine symptoms. Couldn?t see, had blind spots, difficulty driving. Used cold compress on eyes and... Read more
Migraine symptoms. Couldn?t see, had blind spots, difficulty driving. Used cold compress on eyes and forehead in a dark room for 30 mins and symptoms seemed to go away.
26 2021-04-21 vision blurred Brain fog, dizziness, headaches, pain and numbness to left side of head, chills, body aches, trouble... Read more
Brain fog, dizziness, headaches, pain and numbness to left side of head, chills, body aches, trouble breathing, heart arrhythmia, anxiety, left breast pain, upper left arm pain, confusion, trouble concentrating and focusing eyes. All these symptoms began 5-10min after shot was administered and have continued for 2 weeks off and on.
26 2021-04-22 ear pain At 9:00 PM on the day of vaccination (8 hours after vaccination) I felt achy and tired and needed to... Read more
At 9:00 PM on the day of vaccination (8 hours after vaccination) I felt achy and tired and needed to lay down. I also had chills and soreness & swelling at the injection site. I went to bed at 10:30pm. At 1:45 AM (13 hours after vaccination) I woke up with low grade fever, chills, muscle/body aches, fatigue, headache, earache, and sore throat. I could not go back to sleep all night and by 3:00 AM (14 hours after vaccination) I also had nausea and light, dry cough. I had sharp headache and earache pangs. These symptoms persisted. At 11:00 AM the following day (22 hours after vaccination) I took Nyquil containing acetominophen. At around 4:00 AM the next night (39 hours after vaccination) my fever was gone and the other symptoms started to slowly get better the following day.
26 2021-04-22 thirst No major side effects with FIRST dose, only sore arm at injection site for about 12 hours. Second do... Read more
No major side effects with FIRST dose, only sore arm at injection site for about 12 hours. Second dose has resulted in severe swelling at injection site. Pain was comparable to the first dose until about 12 hours later. Before bed I took one standard strength ibuprofen and drank plenty of fluids, with more at my nightstand. Woke up several times throughout the night due to arm pain. The following morning woke up with severe arm pain and swelling, nausea, fatigue, extreme thirst, and chills. No fever. Shoulder region at injection site was red and warm to the touch, with the swollen region about 3.5 inches in diameter. Arm pain continues but is not hindering movement or normal activities. Swollen region has not decreased in size and remains red, warm to touch.
26 2021-04-23 mouth tingling pt was given shot at 12:43 and was instructed to wait 15 mins. at the end of 15 mins pt stated that ... Read more
pt was given shot at 12:43 and was instructed to wait 15 mins. at the end of 15 mins pt stated that she wasnt feeling well. She stated the left side of her tongue was tingling and had burning in her right arm/hand (injection side) along with a small headache in the rear of the head. At 12:58 pt was given 50mg of liquid benadryl and stated that she immediately felt better. She noticed she had a little bit of pain in between her right neck and shoulder. At 1:13 the pt stated that she felt fine enough to leave. She left with her husband and were instructed to visit an urgernt care or ER if symptoms get worse and to call 911 if anaphylactic reaction occurs.
26 2021-04-25 taste impairment 1-2 minutes after injection had a metallic taste in mouth. Noticed about 5 min after injection noti... Read more
1-2 minutes after injection had a metallic taste in mouth. Noticed about 5 min after injection noticed numbness in my left injection arm that spread through all my limbs. Alerted personnel- I became light headed and let them know i was about to faint. Blood pressure raised and heart rate increased rapidly. A rash appeared on my neck and white welts on my face. Was rushed to ER and administered Benadryl, Pepcid, and Prednisone. Confusion and trouble speaking following event. Continued confusion and headache
26 2021-04-26 loss of smell, loss of taste Case was tested on 4/26 for covid 19- test ordered SARS-CoV Ag (Presence) in Respiratory Speciman by... Read more
Case was tested on 4/26 for covid 19- test ordered SARS-CoV Ag (Presence) in Respiratory Speciman by Rapid Immunoassay. results were "Detected" resulting on 4/26. Case was in close contact with a family member who had tested positive- exposure occurred approximately 4/15/21- 4/16/21. Case started having symptoms with onset of 4/20/21 starting with congestion, headache that increase in severity during course of illness and then case developed a loss of taste and a loss of smell.
26 2021-04-26 lip swelling, swollen tongue Patient called in about 45 minutes after her vaccine to say she had an itchy throat and swelling of ... Read more
Patient called in about 45 minutes after her vaccine to say she had an itchy throat and swelling of the lips, tongue and cheeks. She immediately treated it with 50mg of benadryl and she said it subsided.
26 2021-04-26 photosensitivity reaction Raises pink bump at injection site. First noticed 11 pm day after the shot
26 2021-04-26 drooling 26 y/o female with no PMH c/o mild dizziness and nausea 13 min post pfizer covid-19 vaccine 1st dose... Read more
26 y/o female with no PMH c/o mild dizziness and nausea 13 min post pfizer covid-19 vaccine 1st dose. Pt reports no similar prior experiences including syncope, seizures, dizziness, nausea and vomiting with needles, blood draws or vaccines. Pt was given oral fluids and laid down on a cot, she reported mild improvement after laying down ~5 min. Pt then reported a worsening of nausea and then began gagging and spitting up saliva into an emesis bag for ~15min. Pt did not vomit. Pt suddenly placed emesis bag on the cot and lost postural tone, losing consciousness laying backwards onto the cot. Patient did not hit her head. Pt VS remained stable throughout the entire encounter, she was not able to follow commands. Additional information for Item 18: EMS was called, pt was stretcher and attached to monitor. Pt was transferred to hospital via EMS because she was unable to follow commands and has no history of seizures or syncope. Denies: history of similar prior experiences or syncope, HA, SOB, CP, itchiness, rash, respiratory distress, facial/extremity swelling, paresthesias, numbness Vaccine administered @9:03am in left deltoid. Symptoms began @9:16am. Pt ate bread and had coffee for breakfast. PMH: none Meds: none Allergies: NKDA, NKFA, NKEA @9:37am: BP: 112/65, HR: 105 bpm, SPO2: 100% @9:45am: BP: 116/70, HR: 97, SPO2: 99% General: well appearing, obese female Eyes: unable to assess bc pt was closing her eyes and refused to open them Cardiac: normal S1S2, sinus tachycardia, normal rhythm Lung: clear to auscultation b/l, no respiratory distress, no rales Neuro: unable to assess bc pt was not following commands
26 2021-04-27 ear infection, ear pain, eye disorder her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes... Read more
her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; half of her face is numb; ear infection; Bell's palsy/face droopiness; Ear ache/Ear pain; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734 and expiration date not provided), via an unspecified route of administration, administered in Deltoid Left (reported as left shoulder) first dose on 01Apr2021 10:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication includes Multivitamin at 2 gummies once a day for immune support, bone support, and health reasons. The patient historical vaccine includes flu shot and experienced sore arm. On 03Apr2021, the patient stated that two days after the vaccine the patient experienced earache, went to the ED (emergency department) this Sunday diagnosed bell's palsy. On 11Apr2021, the patient experienced ear pain that she thought was an earache or ear infection, then she went to the ER because she woke up with half of her face numb. She says she was diagnosed with Bell's Palsy and she did some research. She says during the trials people did get Bell's palsy but they didn't know if it was connected to the vaccine. She says she is reporting it and she wants to get more information, she's due to get the second dose next Thursday. She says it was a mild case but she was concerned it will come back and come back worse. She says she has a meeting at 3 pm and it is currently 2:13 pm where she lives. The patient stated that now she was left with the face stuff, the face droopiness. The patient was still taking the Bell's Palsy medications every day, she thinks she is getting better. She says about her face being numb she woke up and felt it in her mouth, her lip, her right eye was not cooperating, there was a very noticeable difference between both of her eyes. She says she went to the ER where they did a couple of tests to see if it was a stroke or something else, they didn't do any imaging, with what they aw on her face and the way they were testing the conclusion was Bell's Palsy. She says she saw her primary care physician today because she needed to follow up and it looks like a mild case of Bell's Palsy. She says her face is getting better with medications. She says she is taking Prednisone 60 mg a day for 7 days. She is also taking Valacyclovir 1000 mg 3 times, she clarifies it says to take 1 tablet 1000 mg total 3 times a day by mouth. The events prompted the patient to Emergency room visit and physician office visit. The outcome of the event facial paralysis, hypoaesthesia was recovering. The outcome of the event ear pain was Recovered with Sequel on 11Apr2021. The outcome of the remaining events was unknown.
26 2021-04-27 vision blurred Ever since I got the COVID vaccine I have been having blurry wavy vision that makes my head hurt. My... Read more
Ever since I got the COVID vaccine I have been having blurry wavy vision that makes my head hurt. My first dose was 4/5 and second was recently on 4/26. It has happened 4 times since the beginning of the month. It starts off with waves and blurs and then gives me a massive migraine. I cant see straight when this happens and get bad brain fog. I have to chug water and take 800+ mg tablets of migraine relief to make it better, but it takes a good 2 hours to feel any better at all. I have NEVER had this issue before or have a history of migraines.
26 2021-04-28 sensitivity to light Pounding headache that lasted for 30 hours. Sensitivity to light. Chills around 1am
26 2021-04-29 ear pain, enlarged tonsils First dose of Vaccine did not record in patient system. Patient received second dose on 4/20 Pfizer ... Read more
First dose of Vaccine did not record in patient system. Patient received second dose on 4/20 Pfizer (Lot ER8732) - Pt had a PMHx of Anemia, Bursitis, Fractures, and Motion sickness. She presented with left-sided sore throat and left ear pain. Patient had her first Pfizer Covid vaccination on 3/29/2021 to the left upper extremity. Patient noticed enlarged lymph nodes in the left side of her neck few days later. She had an ultrasound of the neck done on 4/13/2021 which demonstrated to supraclavicular enlarged lymph nodes. This past week (4/21) patient developed a left-sided sore throat and noticed that her left tonsil was enlarged. A couple of days ago, she started to feel some pain in her left ear. Per the note, patient received her second Covid vaccination on 4/20 evening. Pt denied significant fevers.
26 2021-04-29 ear pain Headache and right otalgia on day of vaccination (4/25/21), and then development of right sided Bell... Read more
Headache and right otalgia on day of vaccination (4/25/21), and then development of right sided Bell's palsy on 4/29/21.
26 2021-04-29 vision blurred Four hours after my second dose, I started to grow light-headed. I got up from my desk and stumbled ... Read more
Four hours after my second dose, I started to grow light-headed. I got up from my desk and stumbled over as I couldn't see quite straight. The rest of the evening I rested and stayed hydrated with fluids. From Thursday morning until Saturday morning I was unable to focus, concentrate, see straight, and got "foggy" every time I tried to stand and walk. I had a hard time keeping my eyes open and was very weak. It felt like I was under the influence of something as I felt extremely disoriented. It has been 9 days since my second dose and I am still not "100%" back to my normal self. These side effects were very scary to deal with.
26 2021-04-30 eye strain Received her first dose Pfizer vaccine (LOT#: EW0179 EXP: 8/2021) at 0949 on 4/28/21. Patient alerte... Read more
Received her first dose Pfizer vaccine (LOT#: EW0179 EXP: 8/2021) at 0949 on 4/28/21. Patient alerted, EMT that she was feeling lightheaded and felt like she had very heavy eyes. Patient also started feeling increasing chest pain deep in sternal region. EMT alerted, PHN and another PHN. PHN's arrived on scene. PHN asked EMT to take vital signs at 0955. BP: 68/40, pulse: 61, O2:98%. Patient stated that her chest was increasingly hurting and quickly became a 10/10. Patient became ANOX1 quickly. PHN activated EMS. EMS arrived on scene at 1010. Paramedics started treatment. Patient received IV, EKG, blood/glucose test). Patient was routinely assessed by paramedics. Paramedics took the patients BP. BP: 95/50 and then 88/53. Patient left vaccination site on gurney with paramedics at 1028.
26 2021-04-30 blindness lost vision; migraine; unable to lift head; chest pain; nausea; This is a spontaneous report from a ... Read more
lost vision; migraine; unable to lift head; chest pain; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, administered at the right arm on 07Apr2021 10:45 (age at vaccination was 26 years) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at pharmacy or drugstore. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient experienced lost vision on 07Apr2021 with outcome of recovered on an unspecified date, migraine on 07Apr2021 with outcome of recovered on an unspecified date, was unable to lift head on 07Apr2021 with outcome of recovered on an unspecified date, chest pain on 07Apr2021 with outcome of recovered on an unspecified date, and nausea on 07Apr2021 with outcome of recovered on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of lost vision, migraine, unable to lift head, chest pain, nausea that included migraine medication, ibuprofen, and nausea medication. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
26 2021-04-30 dry throat 26y/o F presented to DET covid vaccine clinic for 1st dose Pfizer. While pt doing observation period... Read more
26y/o F presented to DET covid vaccine clinic for 1st dose Pfizer. While pt doing observation period, pt c/o of SOB. Pt noted to be hyperventilating and hands stiffened up. Pt reports sxs started w/ fatigue and dry throat, followed by sensation of choking. Vitals at 3:15pm: BP 139/97 O2 Sat 100% O2 at RA HR 156 Oral temp 98.4F Albuterol inhaler x2 puffs given at 3:18pm. HR improved to 110. Pt reports sx improvement, but notes whole body numbness. Transported to ED via wheelchair for further eval. Advised she had to be cleared by provider for 2nd dose Pfizer.
26 2021-04-30 oral mucosal blistering, lip blister Roughly 50 painless mouth blisters, all over inside of lips, cheeks, and palate. Extremely sore thro... Read more
Roughly 50 painless mouth blisters, all over inside of lips, cheeks, and palate. Extremely sore throat (nasopharynx) that inhibits eating, drinking, yawning, and sleeping. Went to urgent care and got a cream and gargle, but neither help my throat.
26 2021-04-30 swelling of eyelid I woke up with severe face swelling. Trouble opening eyes fully since eyelids and ?bags? were so swo... Read more
I woke up with severe face swelling. Trouble opening eyes fully since eyelids and ?bags? were so swollen. No issues breathing, and swelling gradually subsided throughout the day until only mildly puffy face by the end of the day. The next morning I was fine and swelling and completely subsided.
26 2021-04-30 toothache Pfizer-BioNTech COVID-19 Vaccine EUA from 10 am Friday, April 30: Fever, headache from 4 pm Friday,... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA from 10 am Friday, April 30: Fever, headache from 4 pm Friday, April 30: Upper back pain (in one particular spot) spreading out to chest and teeth from 8 am Saturday, May 1: Skin rash on neck and chest
26 2021-05-04 deafness, hearing loss hearing loss; muffled hearing; echoing in ear; it got worse; This is a spontaneous report from a con... Read more
hearing loss; muffled hearing; echoing in ear; it got worse; This is a spontaneous report from a contactable consumer. This 26-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 14:45 (Batch/Lot Number: EIM0162) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 (lot number= ER8727) on 22Mar2021 at 02:45PM on right arm and experienced ringing and pulsing in left ear. The patient's concomitant medications were not reported. After second shot on 13Apr2021, the patient reported "it got worse, hearing loss, muffled hearing and echoing in ear" with outcome of not recovered. Therapeutic measures were taken as a result of reported events included over the counter medications. The patient was not tested positive for COVID post vaccination.
26 2021-05-06 blindness Patient states that she felt dizzy and was not able to see. Patient was diaphoretic but denies chest... Read more
Patient states that she felt dizzy and was not able to see. Patient was diaphoretic but denies chest pain, SOB. V/S 130/100 - 54 - 99%. Called and was sent to ER for further evaluation
26 2021-05-08 blindness After the first vaccine, at 5am the next morning, my blood pressure dropped to 90/65 causing my visi... Read more
After the first vaccine, at 5am the next morning, my blood pressure dropped to 90/65 causing my vision to blackout/feel like I was going to faint, and feel like I was going to throw up when standing. I stayed flat in bed the whole day and the second day after (4/8/21), it subsided. After the second vaccine on 4/27/21, it was a much more significant response. This occurred again at about 5am the morning after the vaccine (4/28, less than 12 hours after), my blood pressure began to fall and I was experiencing orthostatic hypotension again. On 4/29 significant body aches and pains (flu like symptoms set in). On Friday 4/30/21, I woke up, and without moving, the room was spinning, I felt like I was going to throw up, had bad headaches, and I was extremely dizzy. I took my blood pressure at it was 80/50. I could not stand or sit up, I had to lay flat with my legs propped up to keep blood flow to my head. I missed work from 4/28-5/1 as I was so hypotensive and symptomatic. I called my cardiologists office on the afternoon of 4/30 to get their advice and confirm that I should NOT take my hypertension and tachycardia medications that night (verapamil and metoprolol). The nurse advised me not to take them that day and to go to the hospital since I was so symptomatic. My mom, a cardiac care nurse, was with me at home, so I decided to stay home and only go in if it dropped any lower. The next day (Saturday) it began to normalize to around 110/70 and Sunday I was 120/80. I did not take any medication Saturday or Sunday, because I did not want my pressure to go low again. Monday I contacted my cardiologists office again, because I was still reading normal with no meds in my system, but was beginning to get chest pains related to the withdrawal from metoprolol, so they had me take the verapamil and metoprolol in normal doses Monday afternoon. Tuesday, I woke up low again (100/60) and had to call off work again. I contacted my cardiologist again, and he advised me to stop verapamil until my pressure got more high and I needed it again and called in a lower dose of my metoprolol (half the strength of what I was taking). It is now 5/9/21 and my pressure is still about 125/85, so I have not been able to resume the verapamil and am still on the half strength metoprolol.
26 2021-05-09 loss of smell, loss of taste EPISODE BEGAN 5/3 WITH A SORE THROAT AND ALLERGY SYMPTOMS, LOSS OF TASTE AND SMELL ON 5/8, DIARRHEA,... Read more
EPISODE BEGAN 5/3 WITH A SORE THROAT AND ALLERGY SYMPTOMS, LOSS OF TASTE AND SMELL ON 5/8, DIARRHEA, NAUSEA, DIZZINESS, HA, COUGH SORE THROAT AND CHILLS
26 2021-05-09 ear pain Cough Ear pain, left Rhinorrhea
26 2021-05-09 swollen tongue Pt. verbalized that head is killing her and states her throat and tongue are swollen. BP 116/82, P ... Read more
Pt. verbalized that head is killing her and states her throat and tongue are swollen. BP 116/82, P 96, SPO2=99%. Pt. states that she is still not feeling well. She verbalized that she always feels unwell after vaccines. She stated that after the first dose of COVID-19 Pfizer, it took 2 hours to feel better. At 3:50pm she stated that she is feeling a tiny bit better. @3:53pm she stated that she is feeling slightly better and that her tongue aren't worsening. Pt. stated that she doesn't want to go to the hospital. But they will stay in the area because her doctors are nearby. EMS instructed pt. to call 911 or primary doctor if symptoms worsen. @ 4pm pt. eating and saying she feels better. Pt. stated that she would like to stay 5 more minutes.
26 2021-05-10 ear pain Ear ache; Fever of 102+; Headache; Chills; This is a spontaneous report from a contactable Consumer ... Read more
Ear ache; Fever of 102+; Headache; Chills; This is a spontaneous report from a contactable Consumer (Patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot# unknown), via an unspecified route of administration on 06Feb2021 at 11:45 (at the age of 26-years) as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had COVID prior vaccination on an unspecified date. Patient received no other vaccine in four weeks. On 07Feb2021 at 01:00 (one day after vaccination), patient experienced fever of 102+, headache, ear ache, chills. No therapeutic measures were given for any of events. Patient underwent lab test: body temperature: fever of 102+ on 07Feb2021. Patient had no COVID tested done post vaccination. The outcome of all the events was not recovered. Information about Lot/ Batch number requested.
26 2021-05-11 ear pain Significant left ear pain that woke me up from sleep 3x last night when I would lay on that side; le... Read more
Significant left ear pain that woke me up from sleep 3x last night when I would lay on that side; left ear pain; Right ear pain; Outer ear pain on rest and highly tender on palpation, most severe around the tragus area; left unilateral left axillary lymphadenopathy; Moderate systemic symptoms; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection via an unspecified route of administration in left arm on 23Jan2021 03:30 PM (Batch/Lot Number ELA262) single dose for COVID-19 immunization at hospital. The patient's medical history was none, and concomitant medications were not reported. The patient had no allergic history. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and patient was not diagnosed with COVID-19 prior to vaccination. 12 hours after the vaccination the patient had moderate systemic symptoms and persisted for 36 hours. 24 hours after the vaccination, the patient developed left unilateral left axillary lymphadenopathy and improved. On 24Jan2021 at 06:30 AM the patient had outer ear pain on rest and highly tender on palpation, most severe around the tragus area. 48 hours after the vaccination the patient had right ear pain (now resolved) and after 72 hours pain started in left side (persisting). It was reported that about 5 days after vaccination, the patient had significant left ear pain woke her up from sleep at night if she lay on that side. No cervical or preauricular lymphadenopathy. Events were not treated. Events resulted in doctor or other healthcare professional office/clinic visit. On 25Jan2021, the patient was tested (Nasal Swab) negative for COVID-19. Outcome of "Outer ear pain on rest and highly tender on palpation, most severe around the tragus area", left ear pain, was not recovered. Outcome of right ear pain and Moderate systemic symptoms was resolved. Outcome of "Significant left ear pain that woke me up from sleep 3x last night when I would lay on that side" was unknown. Outcome of "left unilateral left axillary lymphadenopathy" was unknown. Follow-up attempts are completed. No further information is expected.
26 2021-05-12 eye strain After receiving the vaccine about five minutes later my Chest became very heavy and painful my thro... Read more
After receiving the vaccine about five minutes later my Chest became very heavy and painful my throat felt like I?m knot closing and I passed out I was woken up at the site but I was unresponsive all I remember was them telling me to stay awake the ambulance is on the way I became very nauseous
26 2021-05-13 pain in jaw Fever 103 with shaking, body aches including joints, jaws, and throat.
26 2021-05-15 loss of taste, ear pain, ear infection, loss of smell Got the injection On Friday. Saturday around lunch I took a shower and both my upper arms and across... Read more
Got the injection On Friday. Saturday around lunch I took a shower and both my upper arms and across my upper back was a bad rash that itched and burned. An hour later, the rash faded away. Saturday I woke up sick with my hear hurting a stuffy nose that has gradually increased my symptoms and here it is a month later and I'm still sick.
26 2021-05-16 eye strain 26 y/o female with no past medical history who presents with headache, heavy eyes and palpitations p... Read more
26 y/o female with no past medical history who presents with headache, heavy eyes and palpitations post vaccination. Patients states that this is her 2nd vaccine in the two-dose series. Patient states that with the 1st vaccination patient experienced similar symptoms but worse. Patient denies nausea, throat pain, shortness of breath and chest pain. NP and Paramedics at patient side. Patient vitals were all within normal limits (137/85 BP, 66 HR, 97% and Resp 12). Patient monitored for 15 mins with resolution of symptoms. Patient cleared for discharge home.
26 2021-05-16 visual impairment Anaphylaxis 2 hours after vaccine. Extreme swelling/tightening of throat, difficulty breathing, talk... Read more
Anaphylaxis 2 hours after vaccine. Extreme swelling/tightening of throat, difficulty breathing, talking, dizziness and feeling faint, spots in vision, choking, coughing, chest tightness.
26 2021-05-17 burning mouth syndrome, swollen tongue Sensation of having a lightly burned tongue, mid tongue to tip; Sensitive tastebuds; the feeling tha... Read more
Sensation of having a lightly burned tongue, mid tongue to tip; Sensitive tastebuds; the feeling that the tongue is slightly swollen; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown as did not look) via an unspecified route of administration, first dose administered in Left arm on 31Mar2021 at 10:30 (at the age of 26-year-old) at single dose, second dose administered in Left arm on 28Apr2021 at 10:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medication included progesterone (PROGESTIN) and birth control. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sensation of having a lightly burned tongue, mid tongue to tip. Sensitive tastebuds, sometimes the feeling that the tongue is slightly swollen. No loss of taste. Happened several days after first vaccine in Apr2021 and lasted about a week. Happens again, 2-3 days after the second on 30Apr2021. No hospitalization prolonged involved. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Apr2021 for about a week, then reoccurred on 30Apr2021 with outcome of recovering. Information on the lot/batch number has been requested.
26 2021-05-17 ringing in ears 4/20 around 8:30am head started feeling heavy when running 4/20 around 11am, got very dizzy, nauseou... Read more
4/20 around 8:30am head started feeling heavy when running 4/20 around 11am, got very dizzy, nauseous, buzzing in ears 4/21 around 6pm, got very dizzy, nauseous, buzzing in ears 4/23 visited Primary Care Physican who referred me to Neurologist 4/29 saw neurologist 5/14 visited neurologist a second time Symptoms never went away
26 2021-05-18 painful gums, swollen gums, bleeding gums On the second day after the vaccine, I had swollen, painful gums. My gums bled off and on all day (... Read more
On the second day after the vaccine, I had swollen, painful gums. My gums bled off and on all day (5/14/2021, vaccine was 5/12/2021). On 5/15/2021 the bleeding gums stopped but the swollen gums continued through 5/18/2021. Other than that, I had typical side effects: pain near the injection site, fatigue, extremely swollen and painful lymph nodes.
26 2021-05-20 dry mouth For 2 weeks have been feeling dizzy all day gets even worse at night to the point where I can?t slee... Read more
For 2 weeks have been feeling dizzy all day gets even worse at night to the point where I can?t sleep . Also get really bad dry mouth . Hasn?t gone away so just concerned
26 2021-05-20 swollen tongue, mouth tingling Pt c/o feeling tingling and swelling in her tongue and her face after receiving her vaccine. Pt was ... Read more
Pt c/o feeling tingling and swelling in her tongue and her face after receiving her vaccine. Pt was moved to the Triage room for closer observation. Pt was given oral benadryl and monitored for further symptoms. Pt symptoms continued to progress including itching in her throat and over her face. Pt stated she had reacted to the first dose and was treated with benadryl which successfully managed her symptoms at that time. For this dose, the benadryl did not seem to be effective and d/t progressing symptoms, pt was given IM epinephrine and transported to the ED for further evaluation and treatment.
26 2021-05-23 lip swelling, swollen tongue I received the Pfizer vaccine at 11am on that Thursday and felt no reaction during the 15 minute wa... Read more
I received the Pfizer vaccine at 11am on that Thursday and felt no reaction during the 15 minute wait period. I arrived home and began my regular activities and at approx. 2:30pm started to feel a swelling of my tongue, lips and throat. At around 3pm I took benydral and my symptoms started to slowly go down. I took another at 9pm. I took another in the AM the next day. My throat had started to go down but my tongue and my lips were still swollen. As the day went on my tongue started to go down. By Saturday my lips were the only thing left that were still swollen but that was also going down. By Sunday I was all cleared.
26 2021-05-24 eye movement disorder RN note: Patient received vaccine at 1615, at 1620 patient stated she was dizzy and seeing stars, qu... Read more
RN note: Patient received vaccine at 1615, at 1620 patient stated she was dizzy and seeing stars, quickly after patient was unresponsive and eyes rolled back and patient postured and was shaking slightly. Patient remained in chair and did not fall, RRT and emergency responders notified. Patient recovered in under 1 minute. Initial vitals signs at 1622 BP: 98/64, HR 101, Respirations 34, SpO2 99%. Paramedics arrived at 1630 and BP at that time was 113/72, HR 114, Respirations 30, SpO2 99%. Patient stated no current medications or medical history. Patient handoff given to Paramedics and she left with them per our recommendation. Also reviewed that patient should follow up with her doctor regarding getting the second dose of the vaccine.
26 2021-05-25 loss of taste Sore throat Loss of taste Congestion of nasal sinus COVID-19 virus infection
26 2021-05-25 sensitivity to light Only had arm pain and then was tired up to 27 hrs after shot. After that though, I got extreme pain ... Read more
Only had arm pain and then was tired up to 27 hrs after shot. After that though, I got extreme pain in my head like an severe migraine and I felt like my head was going to explode, dizziness, shaking of my hands and legs (not like cold sweat shaking or something), nausea, and concussion symptoms like the light was too bright and noises were too loud and I was in pain trying to think to say one word and I could not formulate a sentence. The symptoms were not like sick/flu ones like a fever or running nose, I was not sick but in pain like my organs felt like they were shutting shut. Very odd, could not function so I had to go to sleep. Woke up better but not sure if it will occur again. Unknown what was affected from those symptoms. I was at dinner ordering food when this all occurred. I had to then ask right after ordering it to have it to go because I could not stay there with all the noises and light. I felt I was in extreme pain.
26 2021-05-25 drooling Syncope (lost consciousness) in the morning after the vaccine. Accompanied by fever, chills, dizzine... Read more
Syncope (lost consciousness) in the morning after the vaccine. Accompanied by fever, chills, dizziness/presyncope, nausea, headache, body ache, stiff neck on same side as vaccinated arm, sore throat and excessive saliva production
26 2021-05-25 vision blurred, swollen tongue Within 5 minutes after the injection I could feel my tongue swell up. My throat did not close. My vi... Read more
Within 5 minutes after the injection I could feel my tongue swell up. My throat did not close. My vision become blurred. When I got home at 4:30 I got a sudden onset of an intense headache in the front of my head by my forehead and by my temples. The back of my neck is sore and so if my arm st the injection site
26 2021-05-27 feeling of choking 20 minutes post vaccination Pt felt tingling in throat, swelling of the cheeks, and heaviness in the... Read more
20 minutes post vaccination Pt felt tingling in throat, swelling of the cheeks, and heaviness in the chest. Pt was escorted to lie on cot and vitals were obtained: B/P - 122/70, P - 88, Resp - 24, O2 - 99%. EMS was called and Fire Dept arrived on scene at 1650. Pt released by Fire Dept at site at approximately 1720.
26 2021-05-27 thirst, ringing in ears Immediate numbness following injection. Later that evening ~7:00 p.m. joints and muscles in left arm... Read more
Immediate numbness following injection. Later that evening ~7:00 p.m. joints and muscles in left arm/shoulder curled and seized-up. Tingling pins and needles with loss of sensation and dexterity. At bed time May 20th - continued pain, stiffness and swelling accompanied by high fever, chills, excessive sweating, and muscle convulsions. Intense ringing in ears. Next morning (May 21st) I had to miss work. Continued fever, chills, loss of appetite, mild nausea, nerve spasms and locked joints throughout entire body. I felt as though my body was poisoned. The weekend consisted of major fatigue and falling asleep during the day intermittently. Numb arms, weakened grip - could barely make a fist, and had a loss of coordination. Brain fog, delayed thoughts and physical responses. CONTINUED MUSCLE WEAKNESS AND NERVE SPASMS. I contacted doctor for help since my PCP's office was not open until Monday. I began taking Magnesium and B vitamins. I was drinking 1.5 gallons of water daily and still feeling thirsty. Called Doctor on the 24th to report involuntary muscle spasms in neck shoulders and lower back, joint stiffness, numbness, slowed circulation (pins and needles), and a vertigo-like falling sensation at bedtime. Cannot get to sleep comfortably without the spasms and my head rolling. He recommended Benadryl and Tylenol which I began taking which helped the numbness but not the shakiness and nerve spasms. He also offered a muscle relaxer, but I was concerned about waking up and driving to work in the early mornings so I declined since having trouble waking up with all the fatigue. It didn't matter anyway because since then I have missed work due to the sudden weakness, head fog, indigestion, and nerve tremors. Wednesday, I needed assistance going up and down stairs because my limbs felt limp like rubber bands. My joints are unusually cracking while my breathing is more labored. My resting heart rate was elevated and I could feel it beating harder than normal. Thursday, I drove myself to the E.R. because I feel as if I have aged 30 years in under a week. Their blood tests, EKG, and x-rays found nothing abnormal and I received fluids through an IV. However my nervous system feels absolutely shot. THIS IS NOT NORMAL. I WAS INCREDIBLY HEALTHY BEFORE THE SHOT. I WAS NOT INFORMED OF THESE RISKS. I LIVE A CLEAN, ACTIVE LIFESTYLE WITH REGULAR DIET AND EXERCISE. I HAVE NEVER NOT BEEN ABLE TO ARTICULATE MY BODY MOVEMENTS FLUIDLY AND PRECISELY. my doctor suspected I previously had an asymptomatic case of Covid, and that I had an allergic reaction directly related to the vaccine that attacked my nervous system. I FEEL SO MISERABLE AND WRONG. I worry about my quality of life from here on out even though I'm told these symptoms will pass. Today, over a week post my first shot, I have loss of sensation in my arms, tingling in my extremities and base of skull, neck, and lower back (worse at night and when resting). My nerves are still randomly firing and I feel shaky. My body feels as if it has slowed down its automatic functions.
26 2021-06-01 mouth tingling, lip swelling PATIENT HAD REACTION WITHIN ABOUT 10 MINUTES AFTER RECIEVING THE FIRST PFIZER DOSE. 911 WAS CALLED. ... Read more
PATIENT HAD REACTION WITHIN ABOUT 10 MINUTES AFTER RECIEVING THE FIRST PFIZER DOSE. 911 WAS CALLED. PT WAS AMBULATORY AND WAS ABLE TO WALK TO GET ON THE STRETCHER TO BE TAKEN AWAY BY AMBULANCE. REACTIONS WERE: DIZZINESS, NAUSEA, HEADACHE, MUSCLE CRAMPS, CHILLS, COLD SWEAT, TINGLING SENSATION IN MOUTH, LIPS WERE VISIBLY SLIGHTLY SWOLLEN, BLOOD PRESSURE DROPPED 107/59 HR 84, THEN 99/54 HR 88, WEAKNESS/FATIGUE AND DIFFICULTY BREATHING. BLOOD PRESSURE WAS MEASURED BEFORE SHE WALKED TO THE STRETCHER, IT IMPROVED TO 124/80. PT WAS NOT TREATED BY EMS AT THE PHARMACY, PT WAS AMBULATORY, AWAKE AND ALERT AND COHERENT.
26 2021-06-02 eye irritation I got the regular side affects that were warned about, however, I also got allergies for the first t... Read more
I got the regular side affects that were warned about, however, I also got allergies for the first time in my life a few days after. I lived somewhere else this time last year and was not affected by the pollen, but after I got the shot I got allergies every time I went outside. I am not sure if it is a coincidence or if the shot had messed up my immune system in any way. My allergy symptoms occur when I go outside and consist of runny nose that turns into stuffed nose, sneezing, and eye irritation. it is worse when it is cold and have occurred every day since it started. regular side effects that I was warned about that I experienced was pain in the shot area and barely able to lift my arm for about 24 hours. heavy body flu type of symptoms the first night, second night I started having a runny nose and felt a little sick. then the next day or a day after I started having bad allergies when going outside that I am still experiencing 13 days after my first shot.
26 2021-06-02 ringing in ears Patient received first dose of Pfizer on 6/3/2021. She said she had ringing in her left ear 10 minut... Read more
Patient received first dose of Pfizer on 6/3/2021. She said she had ringing in her left ear 10 minutes after. She waited for 15 minutes of observation and left with her husband. She started to feel numbness on the left side of her face, involving her eye, cheek and chin. She decided to come to COVID vaccine clinic rather than return to the clinic where she received the vaccine. Denies shortness of breath or lip/throat swelling. Nurse practitioner on site assessed patient, did a neuro assessment and found it to be normal. Nurse practitioner ordered 10 mg Zyrtec sublingual, it was administered. Symptoms slightly improved but did not subside completely. Patient observed for an hour. Symptoms did not progress. Nurse practitioner discharged patient with instructions to return if symptoms progressed or started to involve airway.
26 2021-06-02 vision blurred, sensitivity to light I was having headaches which was more like a migraine. I had sensitivity to light and blurred vision... Read more
I was having headaches which was more like a migraine. I had sensitivity to light and blurred vision. My estimated date of delivery is 11/10/2021.
26 2021-06-04 oropharyngeal discomfort severe hives/hives measured about 2 inches thick and 6 inches long in some places on my body/I just ... Read more
severe hives/hives measured about 2 inches thick and 6 inches long in some places on my body/I just had hives that were itchy; severe hives/hives measured about 2 inches thick and 6 inches long in some places on my body/I just had hives that were itchy; My throat did not close; This is a spontaneous report received from a contactable consumer or other non hcp. A 26-years-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number: EM9809; Expiry date: unknown), via an unspecified route of administration in the left arm on 06Feb2021 13:00 (age at vaccination 26 years old) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received other mediations in two weeks. Concomitant medication(s) included ethinylestradiol, norethisterone acetate (JUNEL) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 15xr taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID prior to vaccination. On 09Feb2021 12:00pm the patient experienced severe hives 3 days after getting the shot. The patient did not have sensitive skin and had never broken out in hives like she did. The hives measured about 2 inches thick and 6 inches long in some places on her body. The patient throat did not close, and she didn't have any trouble breathing, she just had hives that were itchy. No treatment was received for the events. No covid tested post vaccination. The clinical outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
26 2021-06-05 mouth swelling Swollen mouth and swollen throat, appears vestibular nerve is swollen causing vertigo to flair up. T... Read more
Swollen mouth and swollen throat, appears vestibular nerve is swollen causing vertigo to flair up. Temp 101+, vomiting, labored breathing when laying down, and chills, aches, and other regular symptoms in unison with combined issues
26 2021-06-07 loss of taste, smell distorsion, loss of smell Can't taste or smell; Can't taste or smell; Severe muscle pain in upper back; Fatigue; Shortness of ... Read more
Can't taste or smell; Can't taste or smell; Severe muscle pain in upper back; Fatigue; Shortness of breath doing minimal activity; Strange chemical "smell" coming up from respiratory tract; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration in the left Arm on 10Mar2021 at 14:30 (at the age of 26 years old), as a single dose for COVID-19 immunisation. The patients medical history included asthma and obesity. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. The patient did not received other vaccine in four weeks. The patient did not receive any other medication in two weeks. The patient had no concomitant medications. The patient did not have any allergies to medications, food, or other products. The patient experienced can't taste or smell, severe muscle pain in upper back, fatigue and shortness of breath while doing minimal activity and strange chemical smell coming up from respiratory tract on 13Mar2021at 16:00. The patient did not receive treatment for the reported events. The clinical outcome of the events taste loss, smell loss, muscle pain, fatigue, shortness of breath and strange smell sensation was not resolved. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Reporter's First/Middle/Last Name initial was captured in corresponding field, cannot only capture in First Name field, patient's Initials captured in First Name field, patient's age/units captured as 26 years per event's onset on 13Mar2021, for suspect vaccine: Indication COVID-19 Immunization was captured twice, removed one; Unknown removed from lot number field. For all events: treatment received was captured as no per source if treatment ae: No. For event severe muscle pain in upper back: Coding updated from Muscle pain to Localized muscle pain as per MedDRA. Final sentence no follow-up attempts are possible; information about lot/batch number cannot be obtained was updated as No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected. Concomitant medications were not reported was captured in consolidated narrative while concomitant therapy captured was none. Initial information need be review: The patient did not received other vaccine in four weeks. The patient did not receive any other medication in two weeks. For adverse events Can't taste or smell a week after receiving vaccine. Severe muscle pain in upper back. Fatigue and shortness of breath doing minimal activity. Strange chemical smell coming up from respiratory tract: onset date and time were updated.
26 2021-06-07 bleeding gums Bleeding gums, bloating, extreme fatigue, joint pain (particularly in feet and ankles), headaches, d... Read more
Bleeding gums, bloating, extreme fatigue, joint pain (particularly in feet and ankles), headaches, dizziness. Most symptoms have resolved themselves as of 6/8/2021.
26 2021-06-08 eye movement disorder Vasovagal syncope after roughly 13 minutes post-injection. Syncope lasted a few seconds (roughly 10 ... Read more
Vasovagal syncope after roughly 13 minutes post-injection. Syncope lasted a few seconds (roughly 10 seconds) according to family that helped me. Head went backwards and eyes rolled back in head and then head/body slowly moved forward/sideways. Treatment or follow-up was not provided by anyone at pharmacy location even though family asked for assistance. I left after the 15 minute mark that I was required to stay for. My head felt very tight for the rest of the day, like a rubber band was squeezing my head around both temples.
26 2021-06-09 ringing in ears Pleurisy Tinnitus Dizziness Muscle aches and nerve damage
26 2021-06-09 ringing in ears Pt felt dizzy, shaky, hot (sweating), and had ringing in the ears. Pt reported she felt like she wo... Read more
Pt felt dizzy, shaky, hot (sweating), and had ringing in the ears. Pt reported she felt like she would pass out. Pt checked her blood glucose and it was 93. Pt had some water and orange juice and felt better after about 30 minutes.
26 2021-06-20 vision blurred Patient states that she received her 1st dose of COVID-19 vaccination roughly 1.5 hours ago and roug... Read more
Patient states that she received her 1st dose of COVID-19 vaccination roughly 1.5 hours ago and roughly 20 minutes later was driving her car home when she began experiencing central chest pressure and tightness which occasionally radiates into her abdomen. She states that she was shaking all over, experience blurred vision, vertigo, and numbness to the bilateral legs. Symptoms resolved in 2 hours. Patient discharged from the ED. Patient given Tylenol prior to discharge and to follow up with PCP.
26 2021-06-23 lip blister Blistered lips and extreme skin flushing on the face began 5 days after the vaccine was administered... Read more
Blistered lips and extreme skin flushing on the face began 5 days after the vaccine was administered. Consistent fevers of over 101 degrees for 3.5 weeks. Tried to seek help for most of that time but neither my doctor nor any urgent care in the area would see me because I had a high fever even though I had negative covid tests. Experienced fatigue and cognitive decline and confusion with extremely high fevers. Went to the emergency room with 104 degree fever and they could find no cause. They referred me to infectious disease doctor who put me on steroids to reduce what he called a heightened immune response to the vaccine. The steroids seemed to end the response and fevers.
26 2021-06-25 loss of taste Bell's Palsy symptoms; facial paralysis right side of face; Loss of taste right side of tongue; This... Read more
Bell's Palsy symptoms; facial paralysis right side of face; Loss of taste right side of tongue; This is a spontaneous report from a contactable consumer (the patient, reported for herself). A 26-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0168 and expiry dates was unknown), via unspecified route of administration, in the right arm on 16Jun2021 12:15 PM (at the age of 26-year-old) as single dose for COVID-19 immunization at school or student health clinic. Medical history included bell's palsy (before), known allergies to penicillin, nuts, avocados and bananas. Concomitant medications were not reported. On an 17Jun2021 at 10:15 PM, patient experienced bell's palsy symptoms, facial paralysis right side of face and loss of taste right side of tongue. All the events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient was received treatment in response to the adverse events (Medication for the symptoms). Patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Patient has not been tested for COVID-19, post vaccination. Outcome for all the events was not recovered. Follow-up attempts are needed. Further information is requested.
26 2021-06-29 deafness Severe Heart ache, Left arm severe pain. Swelling, shortness of breath, hearing loss, low blood pres... Read more
Severe Heart ache, Left arm severe pain. Swelling, shortness of breath, hearing loss, low blood pressure, rapid heart rate.
26 2021-06-29 feeling of choking Immediate throat tingliness; Numbness in chest, neck, and lower face; Immediate throat swelling; Num... Read more
Immediate throat tingliness; Numbness in chest, neck, and lower face; Immediate throat swelling; Numbness in vaccine arm; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received second dose of BNT162B2 (Lot Number: EN6208) via an unspecified route of administration in Arm Right on 17Mar2021 (at the age of 26 years old) as a single dose for covid-19 immunisation. Medical history was not reported. It was unknown if patient had any known allergies. Patient previously received first dose of BNT162B2 via an unspecified route of administration in Arm Right on an unspecified date (Lot Number: EN6198) as a single dose for covid-19 immunisation. Concomitant medication included spironolactone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced immediate throat tingliness/swelling, numbness in vaccine arm, chest, neck, and lower face on 17Mar2021 09:15, still lasting through today (20Mar2021). Patient received Epipen and steroid as treatment for events. Event caused emergency room/department or urgent care. The outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected.
26 2021-06-30 inability to speak Onset of upper respiratory symptoms the following week, low-grade fever, sore throat, loss of voice,... Read more
Onset of upper respiratory symptoms the following week, low-grade fever, sore throat, loss of voice, chest congestion lasted 2 weeks. About 4 days in, I went to urgent care made me do a COVID test prior to entry of building and they also did a strep test. They just recommended I stay hydrated and rest. Symptoms were not getting any better so I made a telehealth appt with my doctors office. My primary was unavailable so I saw a different provider. I had my appt with them on May 17th. She sent in 2 prescriptions, albuterol inhaler and codeine cough syrup. The inhaler helped with my symptoms.
26 2021-07-01 swollen tongue Approximately 15 minutes post vaccination, patient started to show signs of anaphylactic reaction. P... Read more
Approximately 15 minutes post vaccination, patient started to show signs of anaphylactic reaction. Patient stated to the interpreter that her tongue was swelling and her throat was starting to close up. I administered 1 injection of Epi Pen to her left thigh. We summoned the resident RN on site. A pulse oximeter was placed on her left hand. She was administered oxygen via nasal cannula. I called 911 from my cell phone. Paramedics arrived on site in about 5 minutes. The paramedics made the decision to transport her to the local hospital
26 2021-07-01 vision blurred Near syncope following vaccination followed by 2 days of HA, elevated HR and blurry vision. March 8t... Read more
Near syncope following vaccination followed by 2 days of HA, elevated HR and blurry vision. March 8th, symptoms worsened. Went to ED and was told she had a fib. 3/25- reported to clinic for continued fevers, blurry vision, poor appetite, HA, dizziness, body aches and increased HR. Returned to clinic on 3/29, 4/8 and 4/15 with a similar constellation of symptoms. 5/11- seen in the ED for migraine. 5/12- Seen again in the clinic with autoimmune panel run. Seen again on 5/17 in the clinic and in the ED on 5/30 for ongoing tachycardia and dizziness that worsens throughout the day. Additional neuro and cardiology work ups requested.
26 2021-07-05 bloodshot eyes, mouth discomfort, eye disorder, tongue disorder, taste disorder By June 25th I had two pimples on my tongue, I had them for three days and also every night for thos... Read more
By June 25th I had two pimples on my tongue, I had them for three days and also every night for those three days my left arm hurt really bad. By June 28th, in the morning the pimples disappeared and by 2:00 pm half of my tounge was tasting salty and the other half sweet. June 29, my left eye was red, inflamed, and wasn't responding. June 30th my left side of the mouth was not responding either.
26 2021-07-07 visual impairment After receiving the second dose, around May 8th, I started developing symptoms of seeing stars in my... Read more
After receiving the second dose, around May 8th, I started developing symptoms of seeing stars in my vision and I had lower extremity edema. On May 18th, I went to a regular prenatal appt and I had 2 blood pressure readings. Both readings were around 150/90. I also had hand and facial swelling and still had pitting edema in my lower extremities. When I was sent to triage, they ran standard tests and found that from the urinalysis, there was protein in my urine. I was diagnosed with pre-eclampsia without severe features and was sent home to monitor myself. On 05/26, I had a headache that would not resolve with Tylenol so I had to go back to triage. I was given a fluid bolus and the headache went away and was sent back home. On 05/28, the headache returned and would not resolve with Tylenol. I went back to triage and the midwife there decided that I was going to be induced to deliver. I had a vaginal delivery, 5 weeks early . My son weighed 6bs 8.5oz. I do not have any other children and I did not have any miscarriages. There was a threat in the early stages of my pregnancy of a miscarriage. My son had to be in the NICU for 2 weeks. When he was born he had respiratory distress, low sugar levels and that resolved within 48 hours. Then he developed jaundice and he had poor feeding. As of today, we are doing great.
26 2021-07-10 sensitivity to light, ringing in ears Brain zaps/Electric shock feeling; Constant, intense headaches with light sensitivity.; light sensit... Read more
Brain zaps/Electric shock feeling; Constant, intense headaches with light sensitivity.; light sensitivity; Muscle weakness and trembling.; Pressure in head.; Nausea; Full body tremors; Fully body chills and shuddering; extreme Fatigue.; Disassociation.; Heavy period a week early.; Tinnitus.; It impacts her ability to function normally.; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8734) as single dose for COVID-19 immunisation. Medical history included Anxiety, herniated disc. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included trazodone (TRAZODONE); fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported; birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since 12Apr2021, the patient experienced events: Constant, intense headaches with light sensitivity. Muscle weakness and trembling. Brain zaps. Pressure in head. Nausea. Full body tremors. Fully body chills and shuddering, lasting over an hour at a time. Extreme fatigue. Disassociation. Heavy period a week early. Tinnitus. It's been 2 months and the patient still had muscle weakness and electric shock feelings in most of her body, particularly upper body. It impacts her ability to function normally. Tinnitus had worsened and was now constant. Adverse event result to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment. Treatments for AE reported as Fluids, Cat of brain, bloodwork. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.
26 2021-07-11 deafness unilateral About three months after receiving the vaccine, I suddenly lost hearing in my right ear. My doctor d... Read more
About three months after receiving the vaccine, I suddenly lost hearing in my right ear. My doctor diagnosed me with Sudden Sensorineural Hearing Loss and prescribed Prednisone to treat it. I'm not sure if this is related to the vaccine, but I've read reports of people who recovered from covid or received the vaccine experiencing hearing loss, so I thought I would submit it here just in case it's related. (I have never tested positive for covid, nor did I ever suspect that I had it)
26 2021-07-12 ear discomfort Four days after shot developed horrific cough with green mucous, sore throat, muscle pain, brain fog... Read more
Four days after shot developed horrific cough with green mucous, sore throat, muscle pain, brain fog, intense arm weakness, and hearing loss. It is 7/13/21 and the symptoms of muscle pain have warn off, but still have hearing loss in both ears as if they were plugged (like being on an airplane) but do not pop. Still have some minor brain fog, as well as coughing up mucous, but the cough is getting better. When the symptoms started, I went to urgent care as I read that these were not symptoms of the vaccine. A rapid COVID test was performed and was negative, and was prescribed an inhaler.
26 2021-07-12 feeling of choking, mouth tingling 17:50 - mild tingling on tongue. Denies any itching, tightness, or other symptoms. Gave water 18:00 ... Read more
17:50 - mild tingling on tongue. Denies any itching, tightness, or other symptoms. Gave water 18:00 - Mild tingling in throat and tongue. Gave Benadryl 50 mg PO at 18:02. O2 sats 97%, heart rate 89 18:24 - vomited, no other GI complaints. No progression of tingling on tongue or throat. Gave crackers. 18:46 - Slight tingling in throat and tongue resolving 18:55 - symptoms all resolved. No distress or further symptoms noted. Discharged with instructions to call 911 if any signs of respiratory distress, or new/worsening GI, or cardiac symptoms.
26 2021-07-12 vision blurred, pain in jaw Symptoms within 24 hours after injection: headache, nausea, jaw pain, chills, tightness in chest Sym... Read more
Symptoms within 24 hours after injection: headache, nausea, jaw pain, chills, tightness in chest Symptoms between 24-48 hours after injection: tingling in left hand, blurry vision, light-headed
26 2021-07-14 ear pain, mouth numbness, ear discomfort So April 23rd during the day I felt a weird numbness in my tongue on the right side. I thought that ... Read more
So April 23rd during the day I felt a weird numbness in my tongue on the right side. I thought that maybe I burned it or bit it or something similar. Then I went to work that night because I worked over nights(it was a very stressful night). About halfway through the night into the early morning may be about 3:00 a.m. I started to feel we are numbness on the right side of my face I cannot just chalked it up to stress. When I left in the morning if I like it wasn't really moving right, just felt a little off. It was about 7:00 a.m. At this point I still thought I was just overly stressed I told my husband when I got home and just tried to lay down to relax. I had had a slight ear ache for about 3 days but at this point it became more uncomfortable than it had been and my face felt like It was getting worse and it really started to worry me. So I decided to go to the walk in at Medical group. I saw the nurse practitioner. At this point my face wasn't doing everything it was supposed to be doing but it wasn't fully numb yet. She said it could be due to an ear infection so she checked my ears but she said that it was weird because it was just slightly red. She wanted to transfer me over to the emergency Room is so that I could get a cat scan done. The doctor at the ER said that she wouldn't do a cat scan at this point she would just treat the ear infection so there was no point in moving me over to the ER. So the nurse practitioner prescribed a couple different medications and suggested that I follow up as soon as possible with my primary. Throughout the rest the day on April 24th ,when I saw the nurse practitioner, my face got progressively worse and wasn't moving very much closer to the end of the night. By the next day my right side of my face was not moving at all and that was April 25th. April 26th As soon as possible in the morning I called my primary care doctor and they got me in immediately to see her. She was unsure it was due to the ear infection and wanted to get more tests done to make sure that something else wasn't causing it and it could get worse. In at this point there was pain slightly so I had taken some time off from work to get the test done. The tests were an MRI scan and some blood work. Then I had a follow up appointment with her right after. With in a couple days after first seeing my primary I had so much pain that I couldn't even get out of bed. It hurt to even slightly touch that side of my face or neck. They said with it being nerve pain there wasn't much that they could give me or do to get that would help it go away. I ended up having about 2 weeks off from work before I went back not sure if I was fully ready with of the pain that I was having in my face still was not working but I could not afford not to. All the medication and everything that I was on during the 1st 2 weeks had caused my palpitations to act up so I ended up having to get more tests on top of it to make sure that it was not negatively affecting my heart. It's been over 2 months closer to almost 3 months and my face is now slightly working not all the way though but it is getting there. so not fully recovered. and having to watch my heart rate and thyroid levels (since i had been having good levels for two years she was worried it would make it act up or cause a problem with the nodules i have on thyroid. ) hopefully I haven't missed any information. Just hoping there is no perminent damage or side effects and that after some more time it fully goes away.
26 2021-07-18 eye floaters, blindness A week after my first dose, I had loss of vision for about 20-30 minutes. I also saw floating spots/... Read more
A week after my first dose, I had loss of vision for about 20-30 minutes. I also saw floating spots/bright light float from my right eye to my left eye. Four days after my second dose, I experience the same side effect, however the loss of vision occurred for only 10 minutes this time. For both times, I called the neurologist I have been seeing. I had Lasik eye correction so I know I have perfect vision. I have not experienced these side effects ever since.
26 2021-07-19 mouth numbness had very heavy legs; a sharp and constant pain in my chest; my arms, legs and mouth have gone numb; ... Read more
had very heavy legs; a sharp and constant pain in my chest; my arms, legs and mouth have gone numb; my arms, legs and mouth have gone numb; had a very bad headache; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0196 and expiration date: not reported), via an unspecified route of administration, in Left arm, on 28Jun2021 at 11:30 (at the age of 26-year-old), as DOSE 1, SINGLE for covid-19 immunization at Pharmacy or Drug Store. Medical history included penicillin allergy. The patient's concomitant medications were not reported however it reported that the patient received an unspecified antibiotic within 2 weeks of vaccination. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has not been tested for COVID-19. On 08Jul2021, the patient had very heavy legs, a sharp and constant pain in chest, her arms, legs and mouth have gone numb and have had a very bad headache. No treatment was taken as a result of events. It was reported that events result in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered at time of report.
26 2021-07-20 swollen tongue, lip swelling PATIENT HAD LIP AND TONGUE SWELLING AFTER PFIZER VACCINE. SYMPTOMS STARTED AFTER 10MINUTES. ONE DOSE... Read more
PATIENT HAD LIP AND TONGUE SWELLING AFTER PFIZER VACCINE. SYMPTOMS STARTED AFTER 10MINUTES. ONE DOSE OF EPIPEN WAS ADMINISTERED AT PHARMACY. PATIENT WAS ALSO GIVEN 25MG OF DIPHENHYDRAMINE.
26 2021-07-21 loss of smell, loss of taste The client contracted COVID-19 even after receiving both doses in a series of the vaccine. The clien... Read more
The client contracted COVID-19 even after receiving both doses in a series of the vaccine. The client experienced a cough, muscle aches, loss of taste and smell, nasal congestion, headache and fatigue.
26 2021-07-23 eye swelling Swollen eyes, headache, light fever, sore arm
26 2021-07-26 tongue itchiness Patient received vaccine dose 5/13/21 at 1754. The patient reported extreme pain and soreness on 5/... Read more
Patient received vaccine dose 5/13/21 at 1754. The patient reported extreme pain and soreness on 5/14/21. Two days after her second vaccine shot (5/15/21) she presented with a rash on her right facial cheek and chest. Her right ear was also red and the patient complained of having an "itchy tongue." Patient received tylenol and benadryl. A few hours later, the patient reported the pain was getting were and the RN did a full assessment and found that the patients rash had become worse on her ear and that the patient's speech was slurred. Vital signs were obtained and WNL. No respiratory distress. Pt sent to ED for evaluation and returned later that evening to Rehab facility.
26 2021-07-27 ear pain covid s/s including cough, headache, congestion, runny nose, chills, night sweats, fatigue Treatment... Read more
covid s/s including cough, headache, congestion, runny nose, chills, night sweats, fatigue Treatment: tessalon perles, OTC zinc, OTC vitamin c, Augmentin, OTC probiotics Day 1-3: scratchy throat Starting Day 3: headache, ear ache, congestion, cough Day 4: cough, night sweats, chills, fatigue Day 5 to present (Day 23): productive cough transitioned to dry cough
26 2021-07-27 visual impairment Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Visual Changes/Disturbances-Severe
27 2020-12-31 eye swelling I woke up with significant right-sided facial and eye swelling currently still present although impr... Read more
I woke up with significant right-sided facial and eye swelling currently still present although improved in severity. Other symptoms included pain/heat at injection site, myalgias, fatigue.
27 2021-01-01 ringing in ears Patient began to feel light headed immediately after vaccine was given. She noted ringing ears and d... Read more
Patient began to feel light headed immediately after vaccine was given. She noted ringing ears and dizziness. She No epinephrine was given and she was able to walk out after ten minutes of sitting with head held forward.
27 2021-01-03 ear pain, ear pain received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakene... Read more
received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakeness on 12/31 11:00 am notices pins needles on left side of face. Resolved then at 5 pm it came back again for a few hours then went away. Then 1/1/21 left forhead tingling above eyebrow. Today feels a little stiffness on the side of my face. Also reported left ear hot and painful 12/31 at 11:00
27 2021-01-03 swelling around the eyes, mouth swelling After the shot I was very light headed , and was taken to the side. Ate some candy , and felt better... Read more
After the shot I was very light headed , and was taken to the side. Ate some candy , and felt better after. About 6 days later is when I woke up with really puffy eyes. Then next day I noticed swelling on the bottom of my mouth , on both sides. Also , my whole right side of my face is swollen with a lot of pressure in it.
27 2021-01-03 tunnel vision lightheaded, dizzy, tunnel vision, sweaty, felt like passing out within minutes of receiving vaccine... Read more
lightheaded, dizzy, tunnel vision, sweaty, felt like passing out within minutes of receiving vaccine.
27 2021-01-04 mouth tingling Tingling sensation in the tongue, high BP
27 2021-01-05 lip swelling I experienced swelling in my face and lips, my chest became covered in hives. I was nauseated and ... Read more
I experienced swelling in my face and lips, my chest became covered in hives. I was nauseated and felt like their was acid in my stomach (burning sensation). I had a headache. Was in the ED 12/31/20. Symptoms continue to happen at random.
27 2021-01-05 lip swelling I experienced swelling in my face and lips. Hives on my chest and neck. I went to the ED 12/31. I fe... Read more
I experienced swelling in my face and lips. Hives on my chest and neck. I went to the ED 12/31. I felt nauseated and there was a burning in my stomach. I had a headache. I have been experiencing these symptoms at random since the vaccine.
27 2021-01-05 tunnel vision Sudden onset shakiness and became light headed with tunnel vision. Almost passed out. Episode lasted... Read more
Sudden onset shakiness and became light headed with tunnel vision. Almost passed out. Episode lasted about 5 minutes but generalized weakness lasted for about an hour.
27 2021-01-06 loss of smell, loss of taste After I got the vaccine I started exp chills and body ache on 12/22.I went to employee health to ge... Read more
After I got the vaccine I started exp chills and body ache on 12/22.I went to employee health to get tested. Since then I returned to work on 1/4 still can't smell/taste .I have to wait 90 days until I receive my 2nd dose Covid vaccine.
27 2021-01-06 vision blurred Dizziness, blurred vision, nausea. Taken to ED from vax site. Given IVF, Zofran inj.
27 2021-01-07 eye swelling swollen left eye, hives on arms and legs, stuffy/runny nose
27 2021-01-07 mouth numbness, taste impairment 10:51 metallic taste in mouth 10:58 tongue numbness, not able to feel tongue and on roof of mouth 11... Read more
10:51 metallic taste in mouth 10:58 tongue numbness, not able to feel tongue and on roof of mouth 11:08 hr 100-113 resp 20 bp 124/72 11:10 progressibly more difficulty when swallowing, lungs cta, individual was anxious 11:12 transferred to ED via wheelchair
27 2021-01-07 mouth tingling Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by ... Read more
Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by tingling lips, tight throat, trouble swallowing and SOB. No obvious signs of swelling of the lips. Used inhaler for SOB which helped marginally. After 1.5 hrs tingling in lips and flushed skin went away. Throat tightness and SOB still remained but weren't progressing so went home after my shift. Later that night around 2100 took 1 25mg Benadryl. Tightness in throat and SOB improved. The next morning 1/5/21, I reported to work for my shift. Tightness and SOB was manageable at this point. At 0800 the tightness in my throat, trouble swallowing and SOB got significantly worse. I was scrubbed into a surgery and had to call for a replacement so I could take Benadryl. I took 1 25mg tablet and 2 puffs of my inhaler and went back to my case. After the Benadryl and inhaler, the tightness in my throat and SOB became slightly more manageable. At 1240 the symptoms came back and I took another Benadryl and 2 puffs of my inhaler with slight relief of symptoms. Stayed the rest of my shift continuing my inhaler as needed and a Benadryl every 4 hrs. At 1600 I developed a headache at the front of my head above my eyes like a weight was sitting there. The next day when I woke up 1/6/21, the tightness in my throat, SOB and headache were worse so I had to call into work. The headache that morning had progressed to 7 out of 10 pain and the pain then included my neck where it attaches to the skull. At 0830 I called employee health and they advised my to go to an urgent care. I was checked over by a PA and was prescribed prednisone 40 mg for 5 days along with Benadryl every 4 hrs and inhaler as needed. I was also nasal swabbed for Covid. After taking the steroid, the headache and neck pain, tightness in throat went away. The SOB also improved. Currently taking the steroid, Benadryl (every 4 hrs) and inhaler 2 puffs as needed. Symptoms are mostly controlled. 1/7/21 tried to cut back the Benadryl to every 6 hrs. Noticed a huge difference in my breathing and had an increase in SOB so went back to every 4 hrs. 1/8/21 still taking steroid and Benadryl every 4 hrs and inhaler. SOB is worse today even with taking Benadryl. Have an appointment with my PCP to talk about getting the 2nd shot.
27 2021-01-08 dry mouth Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the ... Read more
Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the injection site, dry mouth, shortness of breath. Took ibuprofen and Tylenol.
27 2021-01-10 taste impairment 14 minutes post injection, patient laid head on table and started shaking. Complained of severe head... Read more
14 minutes post injection, patient laid head on table and started shaking. Complained of severe headache, h ands, arms and legs numb. No resp problems. 7:50am given 12.5mg of Benadryl IM. 0800 shaking slowing down, but headache, tinglig in arms, legs still numb. 8:04another 12.5 mg of Benadryl IM given. 8:15 shaking stopped but headache continues. Legs remain "heavy" but arms normal. Patient complains of copper taste in mouth. 8:20 legs mostly back to normal. 8:30 able to walk with no symptoms at this time except for headache. Husband arrives to take patient home.
27 2021-01-10 mouth numbness Vaccine: 12/30/2020 0900 AM Symptoms started: 12/30/2020 0925 AM Symptoms: tachycardia 150s, weaknes... Read more
Vaccine: 12/30/2020 0900 AM Symptoms started: 12/30/2020 0925 AM Symptoms: tachycardia 150s, weakness, feeling extremely hot, lip and facial numbness, tightness on throat, difficulty swallowing, shortness of breath Duration: 1 hour Frequency post vaccination: QDAY but less severe ED Visit: 12/31/2020 prescribed Zyrtec and Pepcid Symptoms still occurring going on week two post vaccination
27 2021-01-11 mouth swelling, dry mouth Dry and swollen mouth and back of throat about 25 min after shot
27 2021-01-12 eye itchiness, swelling around the eyes This may not be related to the vaccine, but is strange enough that I'm reporting it. I got my vaccin... Read more
This may not be related to the vaccine, but is strange enough that I'm reporting it. I got my vaccine at around 3, and didn't have any immediate reaction. I have an exercise bike at home, and tried to work out but had to stop after only half an hour of very low effort biking because I couldn't get a deep breathe. usually I can bike for an hour at high intensity no problem and have never had to stop because I felt like I couldn't breathe. I woke up in the middle of the night feeling achy and unwell. When I woke up in the morning I was extremely fatigued and my eyes were itchy and puffy.
27 2021-01-12 pain in jaw 1/11 10:30pm-severe headache and jaw ache/stiff jaw 1/12 AM-headache and jaw ache continues, nausea ... Read more
1/11 10:30pm-severe headache and jaw ache/stiff jaw 1/12 AM-headache and jaw ache continues, nausea 1/12 afternoon-headache and jaw ache continues, nausea, low grade fever (99.9) and chills 1/12 night-headache and jaw ache 1/13 AM and afternoon-headache and jaw ache
27 2021-01-12 swelling of eyelid left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on n... Read more
left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on neck left side/right side/swollen lymph node on collar bone right side; pain in left side of her face; Fever; feel tired; felt like her body was hot; bump on head on left side; face was numb on left side; pimples to left eyebrows; possibly has shingles; This is a spontaneous report from a contactable consumer (patient). A 27 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) at her right arm at single dose for COVID-19 immunization on 29Dec2020. Relevant history included she had UTI, acne and dandruff which she had before the vaccine. Concomitant drug included clomifene citrate (CLOMID) since 30Dec2020 (5 days regimen). Past drug included she was taking Ampicillin 25mg prior to vaccine (last dose 2 days before vaccine). The patient experienced face was numb on left side since 02Jan2021. The patient also experienced pain in left side of her face, swollen lymph node on neck left side/neck right side, feel tired, felt like her body was hot, bump on head on left side, rash on head around bump on her left and fever since 03Jan2020. She took medication for fever. She felt good when take Motrin or Tylenol and then it came back again being tired. Then, the patient stated she sweat a lot since 04Jan2021, she had swollen lymph node on collar bone right side since 05Jan2021. The had left eyelid swollen since 06Jan2021. The patient also experienced pimples to left eyebrows that started Saturday or Sunday and possibly had shingles since unknown date in Jan2021. The patient went to the doctor because the doctor suggested that she had shingles and she had the shingles test on 06Jan2021, while she had not gotten the results back yet. The outcome of event Fever was recovered with sequel on 06Jan2021. Outcome of event possibly had shingles was unknown. The outcome of event she sweat a lot was Resolving. The outcome of other events was not resolved. The events pain in left side of her face, swollen lymph node on neck left side, rash on head around bump on her left, left eyelid swollen and pimples to left eyebrows was worsened.
27 2021-01-12 vision blurred Blurry vision over long period of time - immediately after vaccination
27 2021-01-13 extreme sound sensitivity, sensitivity to light, dry mouth Fever, chills, nausea, light sensitivity, sound sensitivity, headache, dizziness, cold sweats, dry m... Read more
Fever, chills, nausea, light sensitivity, sound sensitivity, headache, dizziness, cold sweats, dry mouth all lasting over 36 hours.
27 2021-01-13 oropharyngeal discomfort When I received my first dose of the Pfizer COVID shot I had no issues. When I received the second d... Read more
When I received my first dose of the Pfizer COVID shot I had no issues. When I received the second dose I had the vaccine injected and then I got up and walked to the monitoring room where we sit for 15 minutes. Immediately upon sitting down in that room I felt very woozy, lightheaded, and my heart was beating out of my chest. I checked my pulse on my smart watch and it was in the 80s but my resting HR is normally in the 60s or 70s. I got nervous at that point so I took some deep breaths and tried to relax and my symptoms improved within a minute. I sat for the remainder of the monitoring period and right at my 15 minute mark all of my symptoms returned. HR in the 100s, lightheaded like I was going to pass out, chest heaviness, and shortness of breath. I alerted the nurse in the monitoring room and she took my BP and HR and they have me a bottle of water. My throat felt a little weird too and I was worried that it was starting to close up, but I was able to swallow water normally. I remained in the monitoring room for about 15 more minutes and at that point my symptoms mostly resolved and I felt well enough to leave. For the next approx 48 hours I have had some mild- moderate chest heaviness. More worse in the initial 24-36 hours after the vaccination.
27 2021-01-13 pain in jaw felt numbness at the injection site; moderate upper arm pain from just below the injection site to a... Read more
felt numbness at the injection site; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; Throughout the day (Dated) it became increasingly difficult to turn my head in any direction and is very painful to move it to the left; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration from 06Jan2021 14:15 (reported as "02:15 PM") at single dose on the left arm as COVID vaccine. The COVID-19 vaccine was administered in a workplace clinic. Medical history included gastrooesophageal reflux disease (GERD), Acid Reflux Disease, Pseudo Tumor and known allergies reported as "Known allergies: Sulfate Drug, Pertussis". The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient reported that directly after the shot, she felt numbness at the injection site and stated "I realize this is normal and the shot was given properly and painlessly in the upper left arm) at approximately 2 am (12 hours after receiving the vaccine)". Patient woke up with moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line. Throughout the day on 07Jan2021, it became increasingly difficult to turn her head in any direction and was very painful to move it to the left. The events occurred on 07Jan2021 -2:00 AM. Events were assessed as non-serious. No treatment was received for the events. No Covid prior vaccination. The patient was not tested for COVID after/post vaccination. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
27 2021-01-13 visual impairment Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, and seeing dark spots (dat... Read more
Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, and seeing dark spots (date/time of onset symptoms 1/13/2021 at 3:00PM) Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, swollen lymph nodes, and hard to swallow ( date/time of onset symptoms 1/13/2021 at 4pm and still ongoing).
27 2021-01-15 mouth numbness Patient developed a feeling of heaviness of her left leg and left arm after approximately 30 minutes... Read more
Patient developed a feeling of heaviness of her left leg and left arm after approximately 30 minutes after vaccine administration. Her tongue became numb. Temperature was normal @ 98.2 F.
27 2021-01-16 blindness, ringing in ears Awoke with chills and very hot. Walked to bathroom to take Advil. Took 600mg Advil became nauseous a... Read more
Awoke with chills and very hot. Walked to bathroom to take Advil. Took 600mg Advil became nauseous and dizzy, sat down and became more dizzy and had loss of vision. Then laid down and a very moments later was able to sit back up. Was very sweaty and with tinnitus which lasted about 10 minutes and then Resolved itself.
27 2021-01-17 eye disorder profound headache; resembling meningitis: could not turn neck from side to side; resembling meningit... Read more
profound headache; resembling meningitis: could not turn neck from side to side; resembling meningitis: could not turn neck from side to side; pressure behind eyes when moving eyes quickly; profound body aches, primarily in the lower back; profound body aches, primarily in the lower back; 100.2-101.0 fever; chills; lethargy; This is a spontaneous report from a contactable Nurse reported for self. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EL1284), via an unspecified route of administration in left arm on 09Jan2021 18:30 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included influenza vaccine inact split 4v (AFLURIA QUAD), desogestrel, ethinylestradiol (APRI). The patient experienced profound headache, resembling meningitis: could not turn neck from side to side, pressure behind eyes when moving eyes quickly. -profound body aches, primarily in the lower back. -100.2-101.0 fever -chills -lethargy on 10Jan2021 12:00. Patient had Rapid nasal swab with negative result on 26Oct2020. Outcome of events was recovering.
27 2021-01-17 swelling of eyelid When I went to get the shot, I had a firm bump with what looked like a white head on my left arm fr... Read more
When I went to get the shot, I had a firm bump with what looked like a white head on my left arm from the first shot. When she injected the 2nd dose, the bump was painful and grew twice in size on my arm and started bleeding. The technician rubbed the area for a fews minutes and the swelling went down. The bump went down, but the whole day, I felt a little sick. At around 7pm, I felt feverish, with muscle aches and chills. My skin was sensitive to touch, I felt nauseous, and I could barely walk. The bottom of my left eyelid also became a little swollen. The symptoms resolved the next morning.
27 2021-01-17 vision blurred, lip swelling, taste impairment, mouth numbness, mouth tingling Vaccination was on Wednesday: about a half hour after vaccine, I experiences increased heart rate, v... Read more
Vaccination was on Wednesday: about a half hour after vaccine, I experiences increased heart rate, vision going black like I was going to pass out, it passed in about 5-10minutes of laying down; also had metallic taste in mouth the rest of that day. Thursday I just felt red, itchy, swollen L arm due to vaccination site. Friday morning my bottom lip was severely swollen with numbness and tingling. It went down by the next day and after taking Benadryl. I have not had an allergic reaction to anything in my life before. Was instructed to not get second vaccine as I may have a more increased reaction to it.
27 2021-01-18 taste impairment, sensitivity to light Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to ... Read more
Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe malaise; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; loss of appetite; Transient dysgeusia; Mild nausea; Pleuritic chest pain; This is a spontaneous report from a non-contactable physician. This 27-year-old female physician (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=E15249), via unspecified route at left arm on 08Jan2021 07:30 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization. Facility type of vaccine was hospital. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. On 08Jan2021 06:00 PM, patient experienced severe headache from 12-36h post administration (as reported), impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia (nearly meningeal signs); mild nausea; pleuritic chest pain; severe malaise; transient dysgeusia; loss of appetite. Treatment for events included initially NSAIDs until had difficulty tolerating was received. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
27 2021-01-18 feeling of choking, swollen tongue Dizziness/light-headed, difficulty speaking, difficulty swallowing, mild tongue and throat swelling,... Read more
Dizziness/light-headed, difficulty speaking, difficulty swallowing, mild tongue and throat swelling, constant need to clear throat, tingle/tickle in throat
27 2021-01-18 feeling of choking tingle in throat; Severe left arm pain; Dizziness; weakness; migraine; This is spontaneous report fr... Read more
tingle in throat; Severe left arm pain; Dizziness; weakness; migraine; This is spontaneous report from a non-contactable other healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration (left arm) on 01Jan2021 10:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that immediately after receiving vaccine (01Jan2021), the patient felt tingle in throat, severe left arm pain, dizziness, weakness, and migraine. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. No follow-up attempts are possible. No further information is expected.
27 2021-01-18 tongue disorder Patient complained of tongue feeling thick at back of mouth/throat. Examined by MD in clinic.
27 2021-01-19 eye twitching Right eye/eyebrow spasms (twitching) intermittently for 24 hours. Previous ASE from 1st vaccinatio... Read more
Right eye/eyebrow spasms (twitching) intermittently for 24 hours. Previous ASE from 1st vaccination on 12/28/20 was right eye/eyebrow spasms (twitching) intermittently for 1 hour
27 2021-01-19 pain in jaw Severe pain in temples and jaw, pain at hips, nausea and vomiting, low-grade fever (highest was 100.... Read more
Severe pain in temples and jaw, pain at hips, nausea and vomiting, low-grade fever (highest was 100.1 degrees F), dizziness.
27 2021-01-19 ringing in ears Chills, body aches, runny nose, Headache, Temperature 99.4, lymph node swollen and tinnitus.
27 2021-01-20 ear discomfort, ear pain, mouth tingling, ringing in ears The night of my second covid 19 Pfizer shot, I began experiencing a strange sensation on the right s... Read more
The night of my second covid 19 Pfizer shot, I began experiencing a strange sensation on the right side of my face near my mouth, cheek, under my eye and on my forehead. It started as a burning sensation and then turned into a dull tingling. It was consistent for 3 days and then began to become intermittent and I still have it today 1 week post vaccine. On day 4 it progressed to tinnitus right more than left ear. Day 4 evening to day 5 was all the above plus ear pain and fullness in my right ear and just pain in the left. I contacted my PCP at this point twice ( once about the initial face symptoms day 1 and to tell her about the ears day 6) and she prescribed me amoxicillin. That night I began having sinus pressure and pain, headache, and malaise. I followed up with an ENT this morning who said everything looked structurally well and could not find a reason for the tingling. She also covid tested me which was negative. Advised me to submit this form at this time due to ongoing symptoms. I will be following up with them within the next few days for further examination.
27 2021-01-20 eye disorder, mouth tingling left arm started tingling; roof of my mouth started tingling then my tongue started tingling and fel... Read more
left arm started tingling; roof of my mouth started tingling then my tongue started tingling and felt like it was getting a little larger; heart palpitations; lower half of my face went numb; Right eye also felt weird like vibrating; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 23Dec2020 15:30 at single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing prior to vaccination of BNT162B2. Concomitant medication included ibuprofen (ADVIL), ibuprofen and escitalopram oxalate (LEXAPRO). The patient stated, "my left arm started tingling and it was very strong by my finger tips" on 23Dec2020 03:45 PM. The patient stated, "then the roof of my mouth started tingling then my tongue started tingling and felt like it was getting a little larger. Then I got heart palpitations. The mouth tingling went away in ten minutes but then 15 minutes later the lower half of my face went numb and that lasted about 10 minutes. Right eye also felt weird like vibrating" on 23Dec2020. No treatment received for the adverse events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and had no congenital anomaly/birth defect. The outcome of the events was recovered on unspecified date.
27 2021-01-20 lip swelling, swollen tongue, mouth numbness Bottom lip swelling with right side tongue swelling and burning Lip swelling and tongue resolved by... Read more
Bottom lip swelling with right side tongue swelling and burning Lip swelling and tongue resolved by the time of awakening next morning but left slight numbness with burning at site of lip swelling as if I had novacain from dentist.
27 2021-01-20 lip swelling At 11:55am pt reported left arm swelling and 25mg of oral diphenhydramine was given to patient (30 m... Read more
At 11:55am pt reported left arm swelling and 25mg of oral diphenhydramine was given to patient (30 minutes after injection). Patient was monitored by staff from thereafter. At 11:52am a second dose of 25mg diphenhydramine was given to patient due to possibly lip swelling reported by nurse. Patient denied shortness of breath or chest pain. By 12:12pm marked lip and face swelling reported by nurse monitoring patient. Again patient denied shortness of breath/wheeze/chest pain. However, we advised patient that lip/face swelling is considered anaphylaxis and because symptoms were progressing and not mitigated by diphenhydramine epinephrine would be advised. Epinephrine 0.3mg via auto injector pen was administered to patient on left outer thigh and 911 was called. EMS arrived at 12:22pm and took patient to local emergency department.
27 2021-01-20 ringing in ears, ear pain Reports on 1/14/2021 had Pfizer vaccine left arm and at night notice burning sensation right side f... Read more
Reports on 1/14/2021 had Pfizer vaccine left arm and at night notice burning sensation right side face and dull tingling following three days and tinnitus bilateral worse on right ear and day four pain in both ears and TMJ and front of ear pain and sinus congestion day 6. She went to Telehealth twice personal nurse practitioner and gave Amoxil for ear pain and ENT evaluated ears,nose and throat and hearing test and covid test which exam and test normal. She stilll suffers today intermittently dull tingling right side sided of face and tinnitis both ear and headache.
27 2021-01-20 ringing in ears, ear pain Reports on 1/14/2021 had Pfizer vaccine left arm and at night notice burning sensation right side f... Read more
Reports on 1/14/2021 had Pfizer vaccine left arm and at night notice burning sensation right side face and dull tingling following three days and tinnitus bilateral worse on right ear and day four pain in both ears and TMJ and front of ear pain and sinus congestion day 6. She went to Telehealth twice personal nurse practitioner and gave Amoxil for ear pain and ENT evaluated ears,nose and throat and hearing test and covid test which exam and test normal. She stilll suffers today intermittently dull tingling right side sided of face and tinnitus both ear and headache.
27 2021-01-21 loss of taste, loss of smell tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-spo... Read more
tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patients mother) reported for a 27-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685), via an unspecified route of administration in the left arm on 17Dec2020 at single dose, for Covid-19 immunisation. Medical history included was sick 4-5 days in Feb2020 or Mar2020. There were no concomitant medications. After the 1st dose, the patient had fatigue after the 3rd day. After a week she felt like she had loose motions in other words diarrhea. She lost her smell and taste both (thought it was 27Dec2020). She got herself tested and it was positive. She tested positive on 28Dec2020. The outcome of event was unknown.
27 2021-01-21 eye pain Chills, headache, nightmares, low fever, plantar fasciitis, shaking, low 02(94), high pulse (120), m... Read more
Chills, headache, nightmares, low fever, plantar fasciitis, shaking, low 02(94), high pulse (120), muscle pain, eye pain, fatigue, fogginess
27 2021-01-21 extreme sound sensitivity Headache with sensitivity to sound and chills, Ibuprofen 400 mg q6 hours for 24 hours
27 2021-01-21 tongue itchiness, lip swelling Approx 3 -5 minutes after vaccine -redness and hives on both arms, chest, and face. Approximately 10... Read more
Approx 3 -5 minutes after vaccine -redness and hives on both arms, chest, and face. Approximately 10 minutes after vaccine- cough, shortness of breath, tongue itchy, lips swelling. Epi pen in L thigh, 50 mg benedryl IM in R deltoid. Brought to emergency room, 1 liter normal saline, pepcid, solu-medrol, 25mg benadryl IV. D/c to home around noon. 1/22/2020- secondary anaphylactic reaction at 945am. Epi pen to r thigh, 50mg PO benadryl, 20mg prednisone. Drove to hospital ER received 1 liter of normal saline, pepcid, 25mg benadryl IV, 40mg prednisone. D/C at 3pm on prednisone taper.
27 2021-01-22 taste disorder Within 5-10 minutes of receiving the vaccine my heart starting racing a little bit, I got a little l... Read more
Within 5-10 minutes of receiving the vaccine my heart starting racing a little bit, I got a little light headed, and had a weird taste in my mouth. The morning after my vaccine (1/22/2021) the Injection site of the vaccine is swollen, hot to the touch, and red/hard. The following day (1/22/2021) around 3:45 pm I broke out in a rash on my face and neck
27 2021-01-25 mouth numbness Numbness on the tongue as of 1/26/2021 at 4:30am. Able to taste. However, have to be cautious to not... Read more
Numbness on the tongue as of 1/26/2021 at 4:30am. Able to taste. However, have to be cautious to not bite my tongue.
27 2021-01-26 dry throat Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at i... Read more
Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; This is a spontaneous report from a contactable other hcp. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9x31 and expiry date unknown), intramuscular on the right arm on 05Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included pneumonia, bronchitis and sinusitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), fish oil (FISH OIL) and olly womans multivitamin. The patient experienced dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site and chills on 06Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jan2021. Therapeutic measures were taken as a result of the events. The patient was advised to rest for 2 days and take Tylenol. The outcome of the events was recovered with sequelae.
27 2021-01-26 oropharyngeal discomfort Felt dizzy and jittery and flushed. HR elevated by NSR. Monitored for greater than 1 hour with sym... Read more
Felt dizzy and jittery and flushed. HR elevated by NSR. Monitored for greater than 1 hour with symptoms occurring on and off during that period. At 1025 she felt flushed again with report of scratchy throat. No distress noted. Oxygen sats 100%. No itching or hives noted. No swelling of the face or airway but since she continued to have symptoms she was placed in wheelchair and taken to the ER.
27 2021-01-26 swelling of eyelid Eye lid swelling / can?t open eye all the way. Left eye. Received Botox injection last week and derm... Read more
Eye lid swelling / can?t open eye all the way. Left eye. Received Botox injection last week and dermatologist said that the Botox and vaccine could be reacting negatively
27 2021-01-27 vision blurred, hearing loss Patient reports ~10 minutes post vaccine becoming sweaty, experiencing blurry vision, and muffled he... Read more
Patient reports ~10 minutes post vaccine becoming sweaty, experiencing blurry vision, and muffled hearing. Writers assessment at 12 minutes , no longer diaphoretic, reports clear vision, slight headache, still slightly muffled hearing. Report no past medical history or allergies, and states last meal was ~20 hours ago. Assessment at 20 minutes - patient reports ?weak neck?, continued headache, vision/hearing returned to normal. Provided with education to seek care of physician if conditions continue or worsen, left site with boyfriend.
27 2021-01-29 mouth tingling While in monitoring area after receiving vaccination client reported hoarse voice, redness, swelling... Read more
While in monitoring area after receiving vaccination client reported hoarse voice, redness, swelling, and tingling of tongue and lips. Redness was in face, chest and right arm. Client denied difficulty breathing or throat tightness. Client reported at this time "significant hx of anaphylactic reaction." This was not noted clearly on screening form signed by client. Client given 50 mg Benadryl per standing order due to symptoms. Epinephrine was not given. 911 was called. Client vitals remained stable with slightly elevated blood pressure ate 140/102. EMS arrived before repeat vitals were taken. Lung sounds were clear and equal bilaterally. Report was given to EMS and care transferred.
27 2021-01-30 eye pain, swelling of eyelid Swollen, puffy eyelids, tenderness around eyes
27 2021-01-30 mouth tingling c/o rash, throat felt "weird", lips felt "tingly"
27 2021-01-31 dry mouth, swollen tongue, lip swelling Headache right after vaccine was administered. Approximately 40min after vaccine was administered I... Read more
Headache right after vaccine was administered. Approximately 40min after vaccine was administered I had severe dry mouth, inability to swallow, at about an hour after vaccine was administered my lips tongue and throat were swelling. Diarrhea, chills, dizziness, severe tremors.
27 2021-02-01 eye discharge, eye swelling Left eye being swollen almost shut with some clear discharge; Left eye being swollen almost shut wit... Read more
Left eye being swollen almost shut with some clear discharge; Left eye being swollen almost shut with some clear discharge; Half of the right side of her face was swelling and being numb; Half of the right side of her face was swelling and being numb; On and off chills; Sweating; Headache; Fever; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), via an unspecified route of administration in left arm, on 31Dec2020 at 09:30, at a single dose, for COVID-19 immunization. The patient's medical history included enlarged thyroid (normal for her), painful menstruations, allergies to cats, dogs, and dust, seasonal allergies, and birth control. The patient's concomitant medication included ethinylestradiol/ norethisterone acetate (JUNEL) as birth control. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 12Jan2021 at 06:15 AM, the patient woke up from sleep with her left eye being swollen almost shut with some clear discharge and half of the right side of her face was swelling and being numb. This persisted for about 3 days with on and off chills, sweating, headache, and a fever on 12Jan2021 (06:15). The symptoms completely dissipated on 22Jan2021. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the events. The patient got a COVID-19 test on 13Jan2021 just to be safe which came back as negative. The patient recovered from the events on 22Jan2021.
27 2021-02-03 vision blurred Patient reported blurry vision in left eye and headache a few minutes after receiving shot. Nurse at... Read more
Patient reported blurry vision in left eye and headache a few minutes after receiving shot. Nurse at clinic monitored her and blurriness became worse and spread to right eye. She said felt like she had her contacts out. Transported to ED by WC. Seen by doc 35min later. Given diphenhydramine 50mg iv x1, famotidine 20mg iv x1, ondansetron 4mg iv x1 and methylprednisolone succinate 125mg x1. Symptoms improved but not resolved. Offered head CT which she declined.. Pt discharged w/short course of oral prednisone and instructed to see pcp in 2-3 days and report back to ED for any acute symptoms. Our corporate health will follow up with her today as well.
27 2021-02-03 visual impairment I woke up at 1:30am with nausea, chills, sweating, and diarrea. I went to the bathroom and vomited,... Read more
I woke up at 1:30am with nausea, chills, sweating, and diarrea. I went to the bathroom and vomited, my vision started darkening. After some time sitting on the toilet I stood up to wash my hands and reach for a hair tie to put my hair up because I was sweating profusely. I felt my vision darkening again and fell to the ground. I never lost consciousness and laid on the ground for a few seconds. I felt my stomach begin to churn again so I got up and sat on the toilet and began having diarrhea again. I texted my sister to come upstairs and bring me a Tylenol and some peppermint oil for my stomach. I took 1000mg of Tylenol, rolled peppermint oil on my stomach and stayed sitting with a cold towel on my head. I was then able to stand up and go back to bed at around 3am (shortly after taking the Tylenol). The next morning I woke up at around 8:30am, still feeling fatigued and mild chills. The diarrea and nausea are gone.
27 2021-02-07 eye swelling Left eye is swollen and the left side of her neck and left shoulder feel itchy Took oral Benadyrl
27 2021-02-09 dry mouth, tongue discomfort Burning tongue; Dry mouth; This is a spontaneous report from a contactable other Health Professional... Read more
Burning tongue; Dry mouth; This is a spontaneous report from a contactable other Health Professional (patient). A 27-year-old female patient received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), intramuscular in left arm on 15Jan2021 12:00 at single dose for covid-19 immunization. Medical history included Asthma. Concomitant medication included ibuprofen (ADVIL), cetirizine hydrochloride (ZYRTEC). The patient previously took amoxicillin and experienced allergies. The patient experienced burning tongue, dry mouth on 15Jan2021 13:30. No treatment received. The patient was not pregnant. The outcome of the events was recovered on Jan2021. No follow up attempts are possible; information about lot/batch number cannot be obtained.
27 2021-02-09 ear discomfort, mouth numbness, mouth pain first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles... Read more
first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles pain all over, and it moved around. like sometimes she felt like an elephant on her lap., lower backpain , head pain, itching all over on and off. rash on her left arm and all along the inside of her arm all the way down for two days and on third left side of head. Day 3 pain with chewing, numbness on the left side inside the mouth with swallowing, combination of numbness and pain on left cheek. pain on the left side of face, neck cheek and chaw line. the neck was numb to touch and didn't feel cold or hot on left side. popping in her ear and inside mouth like pop rocks. and lots of throbbing in the TMJ joint. I could touch it and i could feel the throbbing in my finger. lasted until day 8 and then resolved slowly a little bit each day. was diagnosed with modified bells paulsey. with sensory involvement and didn't treat with steroids. and able to swallow but it felt numb. FaceTime with the INT to gather this info
27 2021-02-09 ear pain Fever; chills; runny nose; ear ache; body aches; swollen glands; This is a spontaneous report from a... Read more
Fever; chills; runny nose; ear ache; body aches; swollen glands; This is a spontaneous report from a contactable Other HCP (patient). This 27-Year-old female Other HCP patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El3248/expiration date: unknown), via unknown route of administration, on 22Jan2021 01:45 PM (at the age of 27 years old) as a single dose on left arm for COVID-19 immunisation at a hospital. Relevant medical history included Depression, insomnia. The patient had no known allergies. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number Ek9231/expiration date: unknown), via unknown route of administration, on 04Jan2021 01:00 PM (at the age of 27 years old) as a single dose on left arm for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Relevant concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that on 23Jan2021 01:00 AM, the patient experienced fever, chills, runny nose, ear ache, body aches, swollen glands. The outcome of the events fever, chills, runny nose, ear ache, body aches, swollen glands was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.
27 2021-02-09 lip swelling Facial tingling, lip swelling, clenched jaw
27 2021-02-09 mouth tingling Pt developed lightheadedness, tingling of tongue and mild nausea 1-2 minutes after injection. She s... Read more
Pt developed lightheadedness, tingling of tongue and mild nausea 1-2 minutes after injection. She suspects that she may have passed out momentarily. BP was 105 systolic. HR: 98, SP02: 100%. She was given snacks and a drink and improved without intervention. She left appx 45 minutes after injection and noted that she felt back to normal.
27 2021-02-11 loss of taste I lost my sense of smell and taste for 1 day. I was tested for Covid 3 times, all coming back with a... Read more
I lost my sense of smell and taste for 1 day. I was tested for Covid 3 times, all coming back with a negative result. The senses came back the next morning.
27 2021-02-11 feeling of choking, mouth tingling, dry throat At 4:57pm patient reports her tongue feels tingling, and throat feels dry and "itchy or tingly". Pat... Read more
At 4:57pm patient reports her tongue feels tingling, and throat feels dry and "itchy or tingly". Patient states she also feels dizzy. At 5:03pm administered 50mg Diphenhydramine, IM. After injection patient reports tongue and throat feel better, but states she is still dizzy. Patient monitored, supine and vitals monitored every 5 minutes. At 5:50 patient states she continues to feel dizzy. EMS called. EMS evaluated patient she states she is unsure if she wants to transported to ER. Patient stands and walks out of clinic escorted by her Husband and EMS.
27 2021-02-13 pupils dilated Patient received first dose of Pfizer vaccine at 1600. Patient reported feeling 'light-headed" immed... Read more
Patient received first dose of Pfizer vaccine at 1600. Patient reported feeling 'light-headed" immediately after vaccine administration and also reported that "this happens after I have blood drawn." Raised patient's legs up on another chair. Patient progressively had decreased level of consciousness, pupils dilated, diaphoretic. BP 84/70, HR thready 80, O2 sat 97%. 911 called and NP on site administered Epinephrine to left thigh (LOT # 022c20aa exp. 01/2022) at 1608 with good effect. EMS arrived and transferred patient to Hospital ED in stable condition. Patient transferred at 1625, VSS with BP 100/70 at time of transfer. Patient was diagnosed in ED with syncopal episode, monitored and discharged at 2044.
27 2021-02-16 eye discomfort 9 hours after, experienced extreme headache, pressure on my eyes 12 hours later, extreme chills and ... Read more
9 hours after, experienced extreme headache, pressure on my eyes 12 hours later, extreme chills and body aches, headache 24 hours later chills, aches, and headache 48 hours later, swollen several lymph nodes in left neck
27 2021-02-17 lacrimation increased Around 1 am I woke up having to sneeze and blow my nose over and over again. It got better for a few... Read more
Around 1 am I woke up having to sneeze and blow my nose over and over again. It got better for a few hours while I slept and then worse again around 9:30 am. I had to call in from work. I?ve been blowing my nose and having watery eyes all day. I took my usual allergy pill but it did not help. I?m reporting this because runny nose isn?t listed as a common symptom. I have soreness in my arm but no other symptoms other than maybe a slight headache and fatigue. I?m worried I might actually be sick but I?ve hardly left my house for months so that seems unlikely.
27 2021-02-21 toothache, pain in jaw 8 days post completion of the COVID-19 Pfizer 2 vaccine series, herpes zoster (shingles) outbreak be... Read more
8 days post completion of the COVID-19 Pfizer 2 vaccine series, herpes zoster (shingles) outbreak began on the left forehead with ocular migraine and hypersensitivity of the left medial portion of the face. Valacyclovir 1000mg TID x10 days was initiated within 24 hours of onset, and rash continued to progress down the face to the left eyebrow, left nostril, and left upper lip. Pain and hypersensitivity of the left upper jaw and teeth began on day 3 of zoster outbreak, and ocular migraine increased in intensity. The rash began to blister on day 4, and is continuing to blister and weep currently (day 5).
27 2021-02-22 mouth numbness After receiving the first dose of the Covid-19 vaccine, I started feeling numbness in my left finger... Read more
After receiving the first dose of the Covid-19 vaccine, I started feeling numbness in my left fingers within seconds. The injection site with in my left arm. Within 5 minutes, I felt some numbness in my lower lip on the right side. Within a few days, the numbness decreased along with my other, more common symptoms, such as fatigue and headache.
27 2021-02-24 ear discomfort A few minutes post vaccination, patient complained of her ears burning, left arm was tingling. Vita... Read more
A few minutes post vaccination, patient complained of her ears burning, left arm was tingling. Vitals taken, MD on site assessed patient, oral Benadryl given. Patient remained in clinic for approx. 45 minutes. Symptoms improved somewhat, reassessed by MD and was discharged to home via personal vehicle with spouse.
27 2021-02-27 dry mouth, inability to speak, dry throat, thirst Fatigue - 4 PM - 02/26/2021-Present Nausea - 5 PM - 02/26/2021-Present Headache - 5 PM - 02/26/2021-... Read more
Fatigue - 4 PM - 02/26/2021-Present Nausea - 5 PM - 02/26/2021-Present Headache - 5 PM - 02/26/2021-Present Inject Site Soreness - 5 PM - 02/26/2021 Increase in Abdominal pain - 5 PM - 02/26/2021-present 101.2 Fever - 5 PM - 02/26/2021-02/27/2021. Lowered to 100.1 2/28/2021-present. Muscle aches - 6 PM - 02/26/2021 - lasted through the night only Dizziness - 10 PM - 02/26/2021-present Dry throat and mouth/unquenchable thirst - 10 PM - 02/26/2021-present Loss of voice (no sore throat) - 11 PM - 02/26/2021 Heart racing - 02/27/2021 since waking up - lasted about 30 hours Rash on left shoulder and arms. Itchy. 2/28/2021 - 9 AM to present
27 2021-02-28 mouth tingling, swollen tongue Patient developed shortness of breath, swelling sensation and tingling of the tongue. Vitals stable.... Read more
Patient developed shortness of breath, swelling sensation and tingling of the tongue. Vitals stable. Airway patent, no voice change, no wheeze. Symptoms improved with observation. Tongue symptoms continued with some swelling. Patient offered IM Benadryl which she refused. Patient transported to ED via EMS.
27 2021-02-28 swelling of eyelid URTICARIA, THROAT TIGHTNESS, EYELID SWELLING
27 2021-02-28 swollen tongue, feeling of choking, blindness transient After 5 minutes of reciving the vaccine I immediately felt my tongue swell and tingle and my throat ... Read more
After 5 minutes of reciving the vaccine I immediately felt my tongue swell and tingle and my throat felt like it was closing. For a few second I could see anything and then went straight to someone to help me.
27 2021-03-01 visual impairment After the vaccine client started c/o seeing spots, feeling dizzy and "almost passing out". She was g... Read more
After the vaccine client started c/o seeing spots, feeling dizzy and "almost passing out". She was given water to drink, a snack and to relax. She was not given any medications. Vital signs stable. No problems since except a sore arm.
27 2021-03-02 dry eye Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled sto... Read more
Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled stomach; Dry eyes and unsettled stomach; This is a spontaneous report from a contactable nurse. A 27-years-old non-pregnant female patient started treceive bnt162b2 (BNT162B2), Lot number: EL9266, intramuscular in left arm on 15Feb2021 at 0900 (at the age of 27 years-old) for COVID-19 immunzation. The vaccination was administered at a workplace clinic. Medical history included Allergy/Sports-Induced Asthma, Lactose Intolerant and food allergies of Kiwi, Lactose Intolerant, Cherry. The patient had a positive COVID-19 test prior to vaccination on 14Nov2020. There was no other vaccinations given within 4 week and concomitant medications within 2 weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), fish oil (FISH OIL). On 15Feb2021 at 10:00, the patient experienced Angioedema/swelling, Difficulty breathing/tight chest, facial flushing, dry eyes and unsettled stomach. Experienced symptoms of flushing 1hour post-vaccination. The clinical course was as follows: She reported that she experienced symptoms of flushing 1hour post-vaccination. About 4 hours later swelling persisted and took Zyrtec to alleviate symptoms, which provided minimal relief. 24 hours post vaccination resulted in ER admission advised per Occupational Medicine at (name). IV SoluMedrol, Bendaryl and Pepcid administered. Overall stay in ER 3 hours. On 17Feb2021, 24 hours post admission rebound symptoms occurring with facial flushing and swelling. Will repeat allergy medication to relieve symptoms PRN. The clinical outcome of the events was recovered with sequalae (as reported by patient: recovered with lasting effects).
27 2021-03-02 lip swelling Lips started to swell about 45 minutes after vaccine was received, Swelling lasted for about 30 minu... Read more
Lips started to swell about 45 minutes after vaccine was received, Swelling lasted for about 30 minutes. I took a benedryl and the symptoms dissipated within 2 hours.
27 2021-03-03 bloodshot eyes Cough and eye redness (may have begun before vaccine dose). BP 138/93 (pulse 74), 98% O2 sat.
27 2021-03-04 taste impairment 5 minutes after injection I experienced a metallic taste in mouth and slight tightening of throat. I... Read more
5 minutes after injection I experienced a metallic taste in mouth and slight tightening of throat. I waited 20 minutes in observation and spoke to nurse and PA who assured me I should be fine if I had no history of anaphylactic shock. 20 minutes later I still felt tightness in my throat, metallic taste in mouth, headache, and now slight difficulty swallowing, at which time I used my Albuterol rescue inhaler. Tightening in throat resolved within an hour. Metallic taste and headache is still present +2 hours after injection.
27 2021-03-06 mouth tingling, mouth numbness Shaky, numbness in tongue, tightness in throat, tingling on tongue, evaluated by EMS-transported to ... Read more
Shaky, numbness in tongue, tightness in throat, tingling on tongue, evaluated by EMS-transported to nearest ER.
27 2021-03-07 eye itchiness First day: chills, headaches, muscle aches, joint aches, second day: itchy rash on hands, feet, and ... Read more
First day: chills, headaches, muscle aches, joint aches, second day: itchy rash on hands, feet, and breasts, itchy eyes and nose, sneezing
27 2021-03-08 smell distorsion, taste impairment 11-12 hours after vaccine I began to have a metallic taste in my mouth and nose. 24 hours later and ... Read more
11-12 hours after vaccine I began to have a metallic taste in my mouth and nose. 24 hours later and there is still a weird smell in my nose and taste in my mouth.
27 2021-03-09 lip itchiness, mouth tingling, mouth itchiness Approximately 90 minutes after vaccination, patient reports noticing 1 hive on left cheek, then wit... Read more
Approximately 90 minutes after vaccination, patient reports noticing 1 hive on left cheek, then within another hour developed hives on face, neck, back, and progressed to chest. Then patient reports tingling and itchiness on lips and in an around her mouth. At this point the patient took benadyl (diphenhydramine) OTC 25mg tablets. Hives resolved post-benadyl within 60 minutes and continued itchiness on skin until next morning. All symptoms/hives/itchiness resolved by next morning.
27 2021-03-15 bloodshot eyes Warm and red skin, bloodshot eyes, dropping blood pressure, fainting, dizziness, nausea, purple feet
27 2021-03-16 oropharyngeal discomfort Patient received first dose of Pfizer vaccine. Patient was told to wait in the observation area for ... Read more
Patient received first dose of Pfizer vaccine. Patient was told to wait in the observation area for 15 minutes post dose to monitor for allergic reactions. Patient after 10 minutes advised the pharmacist that she was having a bit of difficulty breathing, short of breath, and her throat was feeling funny. Patient remained conscious, breathing, and alert during this period, while sitting down. Pharmacist called 911. Pharmacist proceeded to draw up Benadryl for injection. However, as dose was being drawn up, EMS arrived. Within 5 minutes, EMS arrived to assist patient. EMS took patient to provide additional care. Patient was conscious, breathing, and alert as EMS took her for further care.
27 2021-03-16 mouth tingling ?Dizziness almost immediately and still ongoing ?Tongue tingling about 30 minutes after shot and su... Read more
?Dizziness almost immediately and still ongoing ?Tongue tingling about 30 minutes after shot and subsiding around 1:51 ?Pain at injection site ?overall out of it ?off? feeling ?Feeling of panic ?Fatigue ?Chest feeling heavy at about 12pm on day of vaccine lasting about an hour
27 2021-03-16 thirst I began having extreme thirst around 3pm on Tuesday 3/16. I have drank multiple glasses of water and... Read more
I began having extreme thirst around 3pm on Tuesday 3/16. I have drank multiple glasses of water and with little to no relief. It seems to have gotten worse as the day went on. I have also been experiencing frequent urination and fatigue.
27 2021-03-17 swollen tongue Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less tha... Read more
Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less than 15 minutes of receiving the Covid-19 Pfizer vaccine, I experienced chest tightness and shortness of breath. I thought I was having an asthma attack, so I proceeded to use my inhaler. After using the inhaler, I started coughing while trying to breathe. Next my tongue started swelling, followed by my throat and back of the tongue. The nurses / EMT reported that my face turned red and my heart-rate was elevated. The EMT proceeded to give me EpiPen, which almost instantly caused the swelling in my tongue to go down. While being monitored for 3 more hours at the emergency room, the swelling went down even more and breathing became more normal. The following day, I visited my allergist doctor, and I was still experiencing some swelling in my neck and chest tightness. I was given a steroid shot, which seemed to clear the rest of the allergic reaction.
27 2021-03-18 swollen lips Pfizer-BioNTech COVID-19 Vaccine EUA Facial rash over mouth and lips, itchiness, burning, swelling, ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Facial rash over mouth and lips, itchiness, burning, swelling, followed by cold sores
27 2021-03-18 ringing in ears Feverish/Temp (Body temperature) 99.2; chilled feeling; Right chest tightness; Dizziness; Ringing in... Read more
Feverish/Temp (Body temperature) 99.2; chilled feeling; Right chest tightness; Dizziness; Ringing in ears; BP (Blood pressure) 136/88; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269) intramuscularly on 03Feb2021 01:30 PM at single dose in left arm for COVID-19 immunization at School or Student Health Clinic. Medical history included Anxiety/depression. Allergies to medications, food, or other products included Lamictal and Coconut. The patient was not pregnant at time of vaccination. The other medications patient received included birth control within 2 weeks of vaccination. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was feverish but along with chilled feeling, also experienced right chest tightness, dizziness and ringing in ears on 03Feb2021. Adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse events was reported as yes, will go to urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient had labs and procedures included Temp (Body temperature) 99.2; BP (Blood pressure) 136/88; HR (Heart rate) 81; RR (Respiratory rate) 15; Oxygen 100% on 03Feb2021. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269) to reported events cannot totally be excluded.
27 2021-03-19 ear pain Fever on day 1 after the vaccine 102 Ongoing headache still Fever on day7-9 ranging from 101-103 wit... Read more
Fever on day 1 after the vaccine 102 Ongoing headache still Fever on day7-9 ranging from 101-103 with tyelonol neck ache day 7-9 Sore throat day 7-9 Ear ache day 7-9 R arm weakness day 7-9
27 2021-03-20 feeling of choking Patient came to Vaccination Clinic to receive first dose of Pfizer vaccine on 3/18/2021. Patient has... Read more
Patient came to Vaccination Clinic to receive first dose of Pfizer vaccine on 3/18/2021. Patient has a medical history of Ehlers-Danlos Syndrome, Mast Cell Activation Syndrome, POTS (Postural Orthostatic Tachycardic Syndrome). Patient received approval from her doctor and specialists to receive Pfizer vaccine. The patient gave verbal consent to receive the Pfizer vaccine and was vaccinated at 1431. The patient was given an observation time of 30 minutes with EMT. At 1505, the patient reported experiencing tingling in the back of her throat. The patient presented with patchy erythema on chest and neck. The patient was brought into the exam room at 1510 and proceeded to lay down on exam table. At this time, the patient's vitals were taken by RN and found to be within normal limits (BP 115/90, HR 88 BPM, RR 15/min). The patient denied difficulty breathing. She reported feeling minor dizziness and minor itching of neck and arms. The patient's vitals were reassessed as the Lead RN drew up 50 mg/1 mL of IM Benadryl. The patient's vitals at 1518 were: BP 120/85, HR 80 BPM, RR 16/min. The patient remained A&Ox4. The patient was given 50mg of IM Benadryl at 1520 in the left anterolateral region. At 1530, Patient's vitals were: BP 117/80, HR 73 BPM, RR 12/min. At this time, the patient verbalized relief of itching in neck and arms. Upon assessment, the patient's erythema on neck and chest had resolved. At 1537, the patient sat up with her feet dangling below her, her vitals were as follows: BP 132/98, HR 73 BPM, RR 13/min. The patient reported "feeling better" and requested to use the restroom. An RN followed the patient to the restroom. Patient's gait was steady and she denied any dizziness or lightheadedness. Lead nurse educated patient on side effects of Benadryl, including drowsiness. At 1544, the patient requested to drive herself home. She was escorted to her car by lead RN. Patient drove herself home AMA at 1547.
27 2021-03-22 hearing loss, vision blurred Approximately 1031, client stated feeling light headed with blurred vision and stated her ears felt ... Read more
Approximately 1031, client stated feeling light headed with blurred vision and stated her ears felt muffled. Client visibly pale. Client was immediately transferred from the chair down to the floor and her feet were elevated on a chair. Vital sign was taken BP 114/68, Pulse 73, Resp 20, Temp 97.9, SaO2 99%. Client was monitored closely. At 1040, client stated they were no longer feeling dizzy or feeling discomfort with cold compress given. Client was transferred from the floor to sitting on a chair. Client stated she felt better and wanted to leave because her aunt was waiting for her outside. Staff encouraged client to stay longer for observation but client declined. Risk and benefits to waiting longer in observation was explained but patient declined strongly. Vital sign was taken t 1050, BP 113/73, pulse 75, Resp 20, Temp 98.2, SaO2 99%. Patient was discharged and escorted to her car where her aunt was waiting to drive her home.
27 2021-03-22 smell distorsion Chronic nausea, dizziness, headaches, migraines, food/smell aversion (not pregnant)
27 2021-03-24 mouth numbness, drooling, mouth tingling, pain in jaw March 14th developed numbness, tingling of tongue March 21 developed pain under L jaw, L face droop,... Read more
March 14th developed numbness, tingling of tongue March 21 developed pain under L jaw, L face droop, drooling, and increased numbness of tongue no history c/w Lyme exposure, or hiv exposure
27 2021-03-25 lip swelling At 11:00 pm I had an extremely intense seizure that caused me to convulse on the floor while arching... Read more
At 11:00 pm I had an extremely intense seizure that caused me to convulse on the floor while arching my back. My partner thought I was dying as it was much more intense and extreme then normal. I am still having increased seizures in both pain and severity daily. Typically my seizures last 20 minutes and are from 4-5 in discomfort in pain out of ten. Now they are around 7, even a week later. The first severe seizure was a 10 level pain and diabling. I also got severe swelling in my arm of the site, extreme pain in the my arm lasting four days, and two large cold sores. Typically my cold sores small and last for two days. Mine are still active and gave me a fat lip. I also have extreme fatigue but could be caused by the increased seizures and pain of them. I been unable to perform my normal duties and responsibilities, which my seizures typically do not interfere with.
27 2021-03-25 oropharyngeal discomfort PATIENT DEVELOPED RASH IN BOTH ARMS W/IN 10 MINUTES WHICH SPREAD FURTHER TO HER FACE AND BACK, FEW M... Read more
PATIENT DEVELOPED RASH IN BOTH ARMS W/IN 10 MINUTES WHICH SPREAD FURTHER TO HER FACE AND BACK, FEW MINUTES LATER SHE DEVELOPED SHORTNESS OF BREATH AND SENSATION OF HER THROAT CLOSING. SHE WAS GIVEN BENADRYL 50 MG IM AND EPI 0.3 MG IM. THEN PARAMEDICS TRANSFERRED HER TO THE EMERGENCY ROOM.
27 2021-03-27 gaze palsy 27 year old female comes in 3/27/21 at 4:15pm to get Pfizer COVID vaccine. She has no family doctor.... Read more
27 year old female comes in 3/27/21 at 4:15pm to get Pfizer COVID vaccine. She has no family doctor. On her VAR form she states no seizure or history of seizure but does have reaction to HPV vaccine where her throat swelled up and her MD had to give her oxygen year ago. I asked about any other reactions to any other vaccinations and she said no and was willing to get this vaccine. I told her to wait 30 minutes after vaccination to make sure no reaction. At 4:25pm her sister and mom tell us that patient is feeling week and dizzy and ask for water, I go out and check and she is pale and is ready to faint. Mother asks for orange juice which she takes a sip. I ask her if she has any health conditions like diabetes, seizures and they say no, then patient has what looks like a petit mal (absence) seizure. While sitting in the chair her eyes flutter, roll back she tenses up and her body freezes for about 20-30 seconds. I tell staff to call 911 and her sister says she's having "another" seizure. We don't move her but make sure she doesn't fall, once the seizure passes we move her to the ground to lie down. She regains consciousness and is coherent but confused. I do not give EpiPen because I witnessed a seizure. The fire and ambulance arrive to assist her and then her family mentions she did have seizures years ago. After 20 minutes or around 4:50pm she feels better and does not want to go to the hospital and walks out assisted by fire/ambulance staff. The next day I call her and she says she feels better and just has a sore arm and will find new doctor check her out.
27 2021-03-27 tongue discolouration Started getting a bad sore throat on Sunday, March 21st that lasted through Wednesday, March 24th. ... Read more
Started getting a bad sore throat on Sunday, March 21st that lasted through Wednesday, March 24th. Was tested on Tuesday, March 23rd for covid and strep and both were negative. On the 24th I noticed white/yellow spots on my tongue and was diagnosed with oral thrush on March 25th. I have never had oral thrush in my life and the urgent care said it might have been the way my body reacted to receiving my first dose of the vaccine.
27 2021-03-28 swollen tongue right arm went numb and fingers and right foot and leg burning. tongue swelled. then the next day ... Read more
right arm went numb and fingers and right foot and leg burning. tongue swelled. then the next day i had chest pain and rib pain for a long time-5 hours
27 2021-03-28 ringing in ears Patient reported numbness and ringing in ears after recieving vaccine. She stated she felt like she ... Read more
Patient reported numbness and ringing in ears after recieving vaccine. She stated she felt like she was going to pass out. Onsite HR 53 BP 116/67 Patient stated she was a runner, she recovered fully and was free to go home.
27 2021-03-29 ear pain, ear swelling Lymph nodes on left side of neck, armpit, and ear are swollen and hurt.
27 2021-03-29 mouth numbness nausea, vomiting, numbness (tongue and lips). Evaluated by EMS-Cleared
27 2021-03-29 lip swelling, mouth tingling Swollen and red left Arm, itchy left arm, tingling and swelling of lips. Applied ice pack to arm and... Read more
Swollen and red left Arm, itchy left arm, tingling and swelling of lips. Applied ice pack to arm and took 2 benedryl tablets. Initial symptom of itchiness and arm swelling presented approximately 5-10 minutes post injection.
27 2021-03-30 eye pain, eye swelling swelling under both eyes and pain; swelling under both eyes and pain; This is spontaneous report bas... Read more
swelling under both eyes and pain; swelling under both eyes and pain; This is spontaneous report based on the information received by. Galderma Reference Number: GL-012221-1879. A contactable Physician reported for a 27-year-old female patient that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration from 18Jan2021 to 18Jan2021 at single dose for covid-19 immunization. Patient's medical history included recently testing positive for COVID-19 (date unknown). Past drug included Restylane from Jun2020 to an unspecified date for tear troughs. Concomitant medications were not reported. Patient injected with Restylane to tear troughs in Jun2020. The patient received the first dose of the COVID (Pfizer) Vaccine on 18Jan2021. Reported swelling under both eyes and pain on 20Jan2021. Swelling resolved without treatment by 21Jan2021. The outcome of events was recovered.
27 2021-03-30 lip swelling anaphylaxis; throat tightness; shortness of breath; lip swelling; throat swelling; This is a spontan... Read more
anaphylaxis; throat tightness; shortness of breath; lip swelling; throat swelling; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received the first dose of bnt162b2 (lot number EN6199) via intramuscular on 04Mar2021 at 13:45 PM at single dose in left arm for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient's medical history included ADHD, obesity, anxiety, history anaphylaxis to peanuts and allergies: peanuts. The patient's concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERRAL), diphenhydramine hydrochloride (BENADRYL). "5 min after injection", the patient developed throat tightness, shortness of breath, lip and throat swelling consistent with anaphylaxis. Events onset date reported as 04Mar2021 at 13:45 PM. Events resulted in emergency room/department or urgent care. The patient received epinephrine as treatment. The outcome of events was unknown. It is unknown if COVID tested post vaccination.; Sender's Comments: Based on temporal association and known drug profile the reported anaphylaxis with throat tightness, shortness of breath, lip and throat swelling are assessed as due to bnt162b2. Case will be reassessed if additional information is received.
27 2021-03-30 taste disorder, smell distorsion A couple weeks after receiving my second dose of the vaccine, I started noticing that my perfume, fo... Read more
A couple weeks after receiving my second dose of the vaccine, I started noticing that my perfume, food, and other things smelled rotten or different. My bowel movements (to me) smell like something has died... However, I embarrassingly asked my mother if it smelled like that to her and she said no. I noticed the same has happened with my taste. Certain food like lettuce, black eyed peas, green peas, etc. taste like an onion-y/rotten taste.
27 2021-03-31 lip swelling Patient presented with urticaria to back, abdomen, chest, and face with swelling to bilateral orbita... Read more
Patient presented with urticaria to back, abdomen, chest, and face with swelling to bilateral orbital region and lower lip. Patient treated with 25mg IV Benadryl, 20mg IV Pepcid, and 50mg IV solu-cortef at 2315. Patient was monitored for 2 hours following medication administration. Improvement of symptoms was noted after observation and patient was discharged home.
27 2021-03-31 mouth tingling Initially told MD had localized itching at injection site, then stated to Dr. per MD that her lips f... Read more
Initially told MD had localized itching at injection site, then stated to Dr. per MD that her lips felt tingly
27 2021-04-01 feeling of choking pt arrives in observation at 10:45 after experiencing numbness/ tingling in her left side of her thr... Read more
pt arrives in observation at 10:45 after experiencing numbness/ tingling in her left side of her throat, left arm, right arm, middle of chest. BP 134/95 HR 98 oxygen sat 100% room air. patient rested on stretcher and her symptoms resolved themselves. pt was escorted to the exit via wheelchair and staff
27 2021-04-02 mouth swelling Anaphylactic Reaction, given epi pen at clinic and transferred to hospital by ambulance, had breathi... Read more
Anaphylactic Reaction, given epi pen at clinic and transferred to hospital by ambulance, had breathing tube inserted because swelling in throat and mouth would go down with epinephrine treatments, stayed in ICU for 4 days with epinephrine, Benadryl, and steroid treatments. Breathing tube was removed on third day in hospital.
27 2021-04-04 swollen tongue Patient states that she has tightening , chest tightening and swelling of the tongue. Patient was tr... Read more
Patient states that she has tightening , chest tightening and swelling of the tongue. Patient was transported to the ER by ambulance.
27 2021-04-06 mouth numbness, swollen tongue Within 5 minutes of receiving the Pfizer COVID-19 vaccine, I had terrible hot flashes and was unable... Read more
Within 5 minutes of receiving the Pfizer COVID-19 vaccine, I had terrible hot flashes and was unable to focus. This subsided within 15 minutes. Within an hour of the vaccine, my tongue went numb and mildly swelled, my face grew hot, and my throat swelled. It was difficult to swallow saliva and water. Within two hours, I grew progressively weaker, light-headed/dizzy, and experienced mild confusion (unable to understand what folks were saying on the onset). I also had quite low blood pressure when observed by the EMTs. My swelling subsided within 5 hours, both through time and the eventually emergency room treatment of Benadryl, Prednisone, and saline.
27 2021-04-06 swelling around the eyes, swelling of eyelid anxiety attack/she did get pretty anxious easily and that probably exacerbated it; Chest pain; Chest... Read more
anxiety attack/she did get pretty anxious easily and that probably exacerbated it; Chest pain; Chest heaviness; Abdominal pain; eyelid got puffy/puffiness mostly on her upper eyelid of her left eye; had eye puffiness in her left eye; This is a spontaneous report received from a contactable nurse (patient). This 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 10:15 (Batch/Lot number was not reported, reported as "one number on there is EN and then she does not know if it is a G or 6 and then 204") as a single dose for COVID-19 immunization. Medical history included ongoing anxiety from 2020, ongoing acid problems from 2020, high cholesterol levels from 2020 (she was not prescribed any medication and the advice given was just for diet and exercise), and ongoing gallbladder problem for years. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the Pfizer suspect. On 10Mar2021, patient had eye puffiness in her left eye. Patient asked if it is safe to take the second dose. Her eyelid got puffy which began 30 minutes after having the Pfizer COVID Vaccine and it is not ongoing but resolved completely after a few minutes. She did not require treatment for the eye puffiness and the puffiness was mostly on her upper eyelid of her left eye. Patient stated that she does not know in terms of causality if the Pfizer COVID vaccine is related to the reported events and was worried because a week after she got the vaccine, she had other symptoms and was not sure if they are connected with the vaccine. She also reported that she does not think the eye puffiness itself is that serious but it is medically significant and the other symptoms she had were chest pain, chest heaviness, and abdominal pain. These symptoms are not ongoing anymore and began around Friday, 19Mar2021 and resolved after a couple of hours of when they began. For the chest pain, chest heaviness and abdominal pain, she just took an antacid Prilosec for treatment. She thought about going to the emergency room but also thought she was having an anxiety attack and was close to having to go to the emergency room that night. She did get pretty anxious easily and that probably exacerbated it. AEs did not require a visit to emergency room or physician office. Outcome of the events had eye puffiness in her left eye and eyelid got puffy/puffiness mostly on her upper eyelid of her left eye was recovered on 10Mar2021, of the event "anxiety attack/she did get pretty anxious easily and that probably exacerbated it" was unknown, and of the other events was recovered in Mar2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the contributory role of the suspect bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to reported events is possible.
27 2021-04-06 swollen tongue About 6 hours after the Pfizer COVID vaccine she developed rash and some tongue swelling. Went away ... Read more
About 6 hours after the Pfizer COVID vaccine she developed rash and some tongue swelling. Went away with benadryl.
27 2021-04-07 mouth tingling Patient received Pfizer Vaccine (Lot # EP7534 Exp: 3/20/2021) @ 12:48 PM on left deltoid. Prior to v... Read more
Patient received Pfizer Vaccine (Lot # EP7534 Exp: 3/20/2021) @ 12:48 PM on left deltoid. Prior to vaccination, patient stated to RN vaccinator, I feel anxious with needles. RN approached patient calmly and explained risks/benefits of vaccine. RN received verbal consent to give vaccine to patient. At 1300, patient at EMT station complaining of lightheadness, tingling in the mouth, and stated feeling anxious. Past medical history includes auto immune disease. No history of severe allergic reactions. Patient reported that she ate 3 hours ago. EMT noticed flushing of the face. At 1305, patient laid down in recliner chair and water offered. Vital signs taken every 5 mins. Patient alert and oriented x3. At 1310, BP 137/95, P 96 strong, RR 16 unlabored. At 1323: BP 138/100, HR 92 thready, RR 12. Upon assessment, skin warm to touch and normal skin color, damp palm, shaky arms and legs. Patient says "it feels like previous panic attack", and reports tingling in the mouth improved. At 1325, RN offered EMS to patient but patient declined. Vitals at 1330: BP 130/90, P 84 thready, RR 14. At 1335: BP 130/90 P 86 strong RR 14. At 1342: BP 120/80, P 80, RR 12. At 1337, 100 ml juice given and patient contacted her boyfriend to pick her up. At 1357, patient left the facility without assistance and with a steady gait.
27 2021-04-08 mouth numbness At minute 9 post-administration of vaccine, patient experienced rapid onset numbness at tongue and r... Read more
At minute 9 post-administration of vaccine, patient experienced rapid onset numbness at tongue and roof of mouth. 30 seconds post-onset numbness began to become less severe. Numbness currently (~48 hours after administration) intermittent and resolves completely upon patient taking 25 to 50 mg Benadryl.
27 2021-04-08 swollen tongue, lip swelling Patient had swelling of lips and tongue within 15 minutes of vaccination. Given Benedryl and epi an... Read more
Patient had swelling of lips and tongue within 15 minutes of vaccination. Given Benedryl and epi and transported to ER by EMS. Report from ER: She had anaphylaxis with progressive tongue swelling despite multiple doses of IM epi and an epi drip. She was ultimately intubated to secure her airway in the face of potential airway compromise.
27 2021-04-08 tongue itchiness, loss of taste, loss of smell, mouth tingling 10:12 am. Almost immediately post vaccine administration, reported back of tongue was tingling. Wit... Read more
10:12 am. Almost immediately post vaccine administration, reported back of tongue was tingling. With in 10 minutes, reported back of tongue was itchy. Visual of tongue, no edema. No history of asthma, or reactive air way disease. No dyspnea reported. VS BP 122/76, P 80, Resp 16. Denies medication allergies. Reported was sick with the Covid Virus 2/17/2021. It took until March 16, 2021 to finally test negative to Covid Virus. Reports not have the sense of taste or smell remains. Second set VS BP 120/78 P 80 Resp 16. After few more minutes, Pt reported less symptoms as "symptoms were dulling.". Pt then reported no symptoms at all. Symptoms resolved after 30 minutes. Pt remained in observation station with no further problems. Reports tongue is normal.
27 2021-04-09 conjunctivitis, dry eye, visual impairment I contracted pink eye and was treated with steroid drops around the same time as my shot. I believe ... Read more
I contracted pink eye and was treated with steroid drops around the same time as my shot. I believe it was 02/10 when my first pink eye symptoms appeared. My mother and son also had it a week prior so I was not alarmed. However, since then, I've been diagnosed with uveitis after the pink eye infection cleared, and have had continuous issues with extreme dry eye and vision changes. My eye doctor is thinking potentially an autoimmune issue, I'm seeing the diagnostic clinic to hopefully uncover this, but I've never had such eye issues before. I've had some eye fatigue that affected my vision in college due to sleep deprivation, but nothing like this. The chronic pain I'm dealing with has been worsened. This could be autoimmune and a random event, or it could be autoimmune undiagnosed that was trigger by the vaccine, or it could be just the vaccine. But since I believe in medicine and vaccines, I believe it is my duty to report the potential issue so that others and research could benefit from my experience should this be related.
27 2021-04-09 mouth tingling, tongue discomfort, mouth discomfort Within five minutes: racing heart beat, full body flush, tingling and burning mouth and tongue, itch... Read more
Within five minutes: racing heart beat, full body flush, tingling and burning mouth and tongue, itching on chest and arms.
27 2021-04-11 loss of taste, loss of smell Received 2nd dose of Pfizer vaccine on 1/18/2021. On 4/9/2021 patient developed loss of taste/smel... Read more
Received 2nd dose of Pfizer vaccine on 1/18/2021. On 4/9/2021 patient developed loss of taste/smell and rhinorrhea. Tested positive for COVID.
27 2021-04-11 lip swelling, swelling around the eyes A few hours after the first dose of the Pfizer shot, I started to have the same reaction (puffy eyes... Read more
A few hours after the first dose of the Pfizer shot, I started to have the same reaction (puffy eyes, nose and lips) as I do when I consume dairy (I did not have any dairy products this day). Immediately after, I had terrible abdominal pain and diarrhea. I had bloody stool and still continue to have bloody stools until today (3 days after the first dose).
27 2021-04-12 eye pain, vision blurred blurred vision with pressure/pain behind both eyes, intermittent episodes lasting minutes
27 2021-04-12 lip swelling Swollen lips and cheeks
27 2021-04-13 photosensitivity reaction Minor anaphylaxis and hives/heat rash behind underarms near shoulder blades. Sensitivity to sunlight... Read more
Minor anaphylaxis and hives/heat rash behind underarms near shoulder blades. Sensitivity to sunlight. Minor anaphylaxis-started about 2 hours after injection and lasted approximately 8 hours. Resolved fully by next morning. Hives/heat rash behind underarms near shoulder blades-started about 3 hours after injection. Was made worse during sunlight exposure. Are minorly itchy. Sunlight Sensitivity lasted for about 24-48 hours. Seems to have resolved.
27 2021-04-14 loss of taste, loss of smell migraine nausea diarrhea lose of taste loss of smell body aches
27 2021-04-14 dry mouth, swollen tongue Complaint of tongue swelling, itchy, and dry mouth, Pt alert & oriented x 4, 4:40 PO Benadryl 25mg, ... Read more
Complaint of tongue swelling, itchy, and dry mouth, Pt alert & oriented x 4, 4:40 PO Benadryl 25mg, Pt's symptoms resolved and left to go home.
27 2021-04-14 dry throat Post vaccine pt developed sore throat. Denies any other symptoms. Transported to med obs via wc at 1... Read more
Post vaccine pt developed sore throat. Denies any other symptoms. Transported to med obs via wc at 1335. Vitals obtained and monitored. Upon discharge pt states sore throat resolved and now experiencing slight dry throat. Pt released to home with significant other at 1415. Vitals as follows: 1345 BP 122/83 HR 94 SPO2 99 1350 BP 106/73 HR 94 SPO2 96 1355 BP 108/76 HR 88 SPO2 99 1406 BP 111/76 HR 90 SPO2 99 1408 SITTING BP 101/72 HR 90 SPO2 99 1412 STANDING BP 108/76 HR 83 SPO2 99
27 2021-04-14 hearing loss Immediately after vaccine pt experienced dizziness, tingling in hands and muffled hearing. Denies tr... Read more
Immediately after vaccine pt experienced dizziness, tingling in hands and muffled hearing. Denies trouble breathing, diaphoresis, and headache. Reports similar symptoms in the past with medical procedures. Pt feels better after water and crackers. Hypertension noted, pt asymptomatic. Pt told to monitor BP at home and follow up with PCP or ER if needed. Pt released to home with husband at 1645. Vitals as follows: 1624 BP 156/79 HR 89 SPO2 97 1630 BP 156/92 HR 97 SPO2 97 1636 SITTING BP 170/106, 163/103 (ASYMPTOMATIC) HR 84 SPO2 97 1643 STANDING BP 155/104 (ASYMPTOMATIC) HR 95 SPO2 97
27 2021-04-15 inability to speak On 4/16, I was unable to move my muscles weren?t working. I was in a lot of pain that over the count... Read more
On 4/16, I was unable to move my muscles weren?t working. I was in a lot of pain that over the counter meds couldn?t help. I had severe migraines. For 4/17, I have shortness of breath and slight chest pain. My voice is going in and out I?m losing it.
27 2021-04-15 lip swelling About 15 minutes after injection patient reporting shortness of breath , difficulty swallowing. thro... Read more
About 15 minutes after injection patient reporting shortness of breath , difficulty swallowing. throat felt swollen and tingly sensations. On assessment patient clear but diminished breath sounds, thready/weak pulse, swollen lips , BP 130/80. At 1359 pharmacy gave first dose of Epi in left leg, pt symptoms only mildly improved, then second dose of epi given at 1406. ER rapid response on site to take patient to ER and assume care.
27 2021-04-15 pain in jaw Woke with up chest, arm and jaw pain on 03/21/2021. Presented to the ED. Her initial EKG was negativ... Read more
Woke with up chest, arm and jaw pain on 03/21/2021. Presented to the ED. Her initial EKG was negative for any acute changes but her troponin was elevated. Cardiology was consulted. Her echo was negative for cardiomyopathy or hypertrophy. But after her troponin continued to rise she was taken to the cath lab to look for ischemia. Her cardiac angiography was negative for obstructive disease, and coronary arteries were completely normal. Had low magnesium and potassium- so started on oral supplementation. Discharged on 03/22/2021 with nitroglycerin (which was not helpful and made her feel worse/nauseated) and to follow up with outpatient cardiac MRI and cardiology. This imaging revealed significant myocardial edema consistent with myocarditis. 04/01/2021 Per Cardiology: -Given that the patient had covid 19 back in November 2019 I believe she may have had a low yield subacute myocardial infection at that time that was somehow exacerbated by her 1st covid vaccine. Therefore, after some consideration and careful discussion I am advising against the 2nd vaccine at this time. -No physical exercise for 6 months given her current myocarditis and family hx of sudden cardiac death -May trial PRN NSAIDS for pain relief -Recommend birth control and no pregnancy until at least after her follow up cMRI -Follow up in 6 months with cMRI prior
27 2021-04-15 ringing in ears I hear ringing in my ears that won?t stop. Sometimes it gets dimmer if i sit up, but it?s really bad... Read more
I hear ringing in my ears that won?t stop. Sometimes it gets dimmer if i sit up, but it?s really bad when I lay down and when I?ve been trying to go to sleep. It?s like a whirring sound, the kind you?d hear from a machine whirring (like when you stand next to an ice cream machine?) There?s also this, like, chugging noise in the background.
27 2021-04-15 ringing in ears 3:30pm In front of vaccination tent w/ c/o dizziness, ringing in ears+sweaty palms after vaccination... Read more
3:30pm In front of vaccination tent w/ c/o dizziness, ringing in ears+sweaty palms after vaccination. EMS @ scene. BP 108/50, T 98.1, O2Sat 100% 3:40pm Proceeded to observation, stated feeling much better. 3:50pm Exited observation verbalized no c/o at this time. Advised if symptoms returned to call 911. Friend driving car.
27 2021-04-15 tongue discomfort Around 25 minutes after vaccine, patient began to feel dizzy and stated that her tongue and throat f... Read more
Around 25 minutes after vaccine, patient began to feel dizzy and stated that her tongue and throat felt scratchy and tight. Patient took a Benadryl 25 mg tablet. After about 20 more minutes patient said her chest felt tight and her left side of face was numb. She could take deep breaths easily but her shallow breaths were difficult.
27 2021-04-15 vision blurred, mouth tingling PATIENT COMPLAINED OF DIZZINESS AND BLURRED VISION AFTER 5 MINUTES OF RECIEVING THE VACCINE. AFTER P... Read more
PATIENT COMPLAINED OF DIZZINESS AND BLURRED VISION AFTER 5 MINUTES OF RECIEVING THE VACCINE. AFTER PHARMACIST CONSULTATION, IT WAS DETERMINED THAT THE PATIENT HAS A PREVIOUS HISTORY OF FAINTING WITH NEEDLES UPON BLOODWORK BUT NOT COMMONLY WITH VACCINES. THE PATIENT ALSO RELAYED TO THE PHARMACIST THAT SHE DID NOT EAT ANYTHING SINCE THE MORNING AND ALL SHE HAD TO EAT IN THE MORNING WAS A BANANA. WE GAVE HER WATER AND MOVED HER TO A ROOM IN WHICH SHE WAS ABLE TO REMOVE HER MASK AND BREATHE EASIER. SHE THEN REPORTED OF TINGLING IN HER UPPER LIP. SHE WAS GIVEN A SNACK TO ASSIST WITH SYMPTOMS OF POSSIBLY HYPOGLYCEMIA. WE MONITORED HER FOR ANOTHER 15 MINUTES CONTINUOUSLY CHECKING ON HER AND HER SYMPTOMS ALL STARTED IMPROVING AND RESIDING. AFTER 30 MINUTES OF CLOSE MONITORING THE PATIENT FELT WELL ENOUGH TO GO HOME.
27 2021-04-16 eye swelling Severe swelling in dermal fillers placed below left and right eyes
27 2021-04-16 tunnel vision FEW MINS AFTER VACCINE, FELT COLD, DIZZY, "UNDER WATER" FEELING, TUNNEL VISION, ASSISTED TO GROUND F... Read more
FEW MINS AFTER VACCINE, FELT COLD, DIZZY, "UNDER WATER" FEELING, TUNNEL VISION, ASSISTED TO GROUND FEET PLACED UP ON CHAIR. FELT SOME RELIEF. BROUGHT TO OBS VIA WHEELCHAIR, PLACED IN TRENDELENBERG, FELT BETTER. SAT UP FOR SNACK AND WATER, HELPED BUT STATES TOOK BENADRYL PRIOR TO COMING PER PCP INSTRUCTION DUE TO FOOD ALLERGIES, SO GROGGINESS THATS REMAINING PROBABLY RELATED TO THIS. SOME DIZZINESS REMAINS SITTING UP BUT MUCH IMPROVED PER PATIENT. STANDING UP PATIENT STATES STILL FEELS BETTER, JUST GROGGY FROM BENADRYL. ESCORTED WITH SIG OTHER VIA WHEELCHAIR TO EXIT WITH NO FURTHER ISSUES AT 1228. 1155 INITIAL BP 125/86 HR 114 RR 18 SATS 98% RA (SITTING, AND PATIENT STATES HR USUALLY OVER 100 WITH ANXIETY) 1210 BP 130/82 HR 110 RR 20 SATS 99% RA 1225 STANDING BP 145/94 HR 106 RR 20 SATS 99% RA
27 2021-04-17 mouth swelling About 15 mins after pt received her vaccine she reported that she was having trouble swallowing . T... Read more
About 15 mins after pt received her vaccine she reported that she was having trouble swallowing . The EMS crew immediately took her vitals and they were WNL BP 120/80 and SpO2 was 98% and remain that way for the duration of her time in observation. Pt stated that she felt like she was getting worse so she was administered Benadryl 50 mg IM by the EMS crew at 1215. at 1230 pt stated her throat was feeling mostly better and She could now swallow but that the inside of her mouth felt like it was swelling. The EMS crew stated that due to them giving her Benadryl their protocol was to call an ambulance. The ambulance arrived and evaluated pt and recommended that she be seen at the hospital. Pt refused stating that she would have her husband that was with her drive her there. Pt was then released to drive herself to medical center.
27 2021-04-17 visual field defect, blindness in both eyes Pt developed sudden left eye partial vision loss on 4/6/2021, 5 days after 2nd dose of COVID vaccine... Read more
Pt developed sudden left eye partial vision loss on 4/6/2021, 5 days after 2nd dose of COVID vaccine. Saw Dr on 4/7/2021 and diagnosed with left branch retinal artery occlusion, admitted to the hospital on 2nd day of symptoms. No treatment indicated. Evaluation undergoing. Imaging negative for acute stroke. Pt continues to have visual field deficit on 4/15/2021 when she was seen for follow up in PCP office.
27 2021-04-18 vision blurred, visual impairment April 6, 2021 - Intermittent blurry/spotty vision for about 10 minutes. Once vision returned to nor... Read more
April 6, 2021 - Intermittent blurry/spotty vision for about 10 minutes. Once vision returned to normal, felt nauseated and emesis x1 then migraine around right eye for approximately 4 hours. April 8, 2021 - Sudden onset of blurry/spotty vision for approximately 20 minutes. Once vision returned to normal, had migraine around right eye for approximately 4 hours. April 13, 2021 - Same symptoms as 4/8/2021
27 2021-04-19 loss of smell, loss of taste First dose 1/13/21 second dose 2/1/21 Covid positive 4/19/21 symptoms stuffy nose/lose of taste and ... Read more
First dose 1/13/21 second dose 2/1/21 Covid positive 4/19/21 symptoms stuffy nose/lose of taste and smell
27 2021-04-19 mouth tingling 1/11/2021: I experienced a bit of an itch on my right foot. 1/12/2021: Then felt it again the next ... Read more
1/11/2021: I experienced a bit of an itch on my right foot. 1/12/2021: Then felt it again the next day. 1/13/2021-1/30/2021: This itch traveled out of my foot and I started to feel this tingling sensations on my right leg. The tingling would come and go. It moved to my left leg and then my arms. I also felt the tingling in my elbows, fingers, neck, boob area, abdomen. My lower back felt tight too. I was also experiencing chest pains, like pressure on my chest that would come on throughout the day. Sometimes 1 a day sometimes 3 times a day. Pressure would come on for about 30 seconds to 1 minute then subside. I also had an increased heart rate (tachycardia). I received the second dose of Pfizer on 1/30 and experienced the ?typical? symptoms the next day. On 1/31/2021 I had body aches, fatigue, low grade fever. The symptoms disappeared within 24 hours, and I did not feel any tingling on that day. On 2/1/2021 in the evening, I started experiencing severe tingling in both lower extremities. On 2/2/2021: I felt the tingling all over my body: legs, torso, forehead, back of head, vagina, tongue, back. I was experiencing severe chest pains. Heart rate was extremely high. On 2/3/2021: I went to the ER, and they sent me home with a referral to see a neurologist. Blood Pressure was extremely high (153/110). On 2/5/2021: I felt this horrible pin pricking sensation up and down my spine that went on for hours. Additionally, my right leg went numb and stayed numb until the next morning. On 2/6/2021: My right leg went numb again in the evening. It resolved in an hour. I also began experiencing some muscle twitching. It started in my right leg but I can feel it in various parts on my body (thighs, buttock, calves, arms, hand, and right underneath armpit on my back). I have burning mostly in my thighs, forearms (near elbows area), and upper shoulders. I have pin pricking sensations around my body. And I have muscle twitching in my arms, legs, back, and hand. Chest pains have resolved, blood pressure is back to normal, and my heart rate isn't so elevated anymore. I also have been experiencing some bad diarrhea the past two months (beginning on 2/19/21 until current)!
27 2021-04-19 ringing in ears Pain in temple, temple is sensitive to touch. There's a pain in my temple when I talk, bite, or hold... Read more
Pain in temple, temple is sensitive to touch. There's a pain in my temple when I talk, bite, or hold my jaw. I've never experienced this in my life before. I'm also hearing a constant ringing in my ears.
27 2021-04-20 oropharyngeal discomfort pre-syncopal, anxious, throat feeling congested/heavy, resolved, pt. left site.
27 2021-04-24 vision blurred Pt reported lightheadedness, nausea and blurry vision at 1424. Patient laid down in anti-gravity cha... Read more
Pt reported lightheadedness, nausea and blurry vision at 1424. Patient laid down in anti-gravity chair and given water. Vitals were BP 110/60, HR 79 bpm, and SpO2 98%. Patient advised to wait for further observation. Patient reassessed at 1505. Vitals were 105/70 BP, 70 HR, and 99% SpO2. Pt stated she felt better after standing up and left facility to self with steady gait and unlabored respirations.
27 2021-04-25 eye twitching Twitching right lower eyelid 3 hours after injection. Spread to right area around mouth within 3 day... Read more
Twitching right lower eyelid 3 hours after injection. Spread to right area around mouth within 3 days. Muscle spasms in legs and arms also. Twitching and spasms have been ongoing for 28 days
27 2021-04-25 vision blurred, mouth tingling Patient, with no past medical history seen today for report of tingling in her upper and lower lips ... Read more
Patient, with no past medical history seen today for report of tingling in her upper and lower lips blurred vision and feeling lightheaded 10 minutes post vaccination. Patient reports that she has allergy to yogurt. Patient also reports that she takes xazyl daily for allergy, however she didn?t take it today. Patient states that this is her first dose in the series. Patient denies being pregnant. NP and Paramedics at patient side. Patient blood pressure is elevated 156/95. Patient denies any history of HTN. All other vials within normal limits (99% RA, 98 HR, 18 Resp, bs 108). Benadryl 25 mg given to patient with a bottle of water and legs were elevated on a chair. Patient BP decreased to 130/90. Patient reports that she feels better after taking the Benadryl. Patient educated on the side effects of Benadryl. Patient instructed not to drive home. She verbalizes understanding and states that her mother will drive her home.
27 2021-04-25 vision blurred Patient began to feel her throat feeling scratchy and then blurry left eye and left arm tingling. ... Read more
Patient began to feel her throat feeling scratchy and then blurry left eye and left arm tingling. Pt then began retching continuously. Vitals stable. Called 911 for transport/observation at Emergency Department as precaution. Pt did not receive any emergency medications. ? The attending physician has indicated that patient had a mild allergic reaction to the vaccine, which then transitioned to a heightened episode of anxiety about how her body was reacting to the shot. The physical reactions she exhibited could have been a direct response to either, or a combination of both of those situations, so he cannot directly pinpoint one main cause. He did advise her NOT to get the second shot. ? She is feeling much better, and the symptoms have all subsided, but she is very tired. The physician recommended she rest for the remainder of the day, so she is going home.
27 2021-04-26 visual impairment Feeling warm all over almost right after injection. She has a little nausea. Minor visual changes, n... Read more
Feeling warm all over almost right after injection. She has a little nausea. Minor visual changes, noticed stars. No tunnel vision
27 2021-04-28 dry throat Heart palpitation 7 days after the first dose, the symptoms last for four days and haven't diminish.... Read more
Heart palpitation 7 days after the first dose, the symptoms last for four days and haven't diminish. After 10 days of the first dose, I now have allergic reactions like running nose, dry and sore throat. I have never had any heart issues or other health concerns.
27 2021-04-29 vision blurred 27 YOF seen after Pfizer vaccination. Previously had a COVID positive tests JUN2020 & 29NOV2020, wi... Read more
27 YOF seen after Pfizer vaccination. Previously had a COVID positive tests JUN2020 & 29NOV2020, with negative results in between. During June illness, PT was asymptomatic, during November illness, PT sts she had similar symptoms to those she began to experience after the first dose of the vaccine, including: dizziness, body aches, fever (unk temp) chills, and tightness in chest upon exertion. After vaccine, PT sts she had the same symptoms as during the November illness but also had mild dizziness upon exertion, though gait steady when walking and no issues driving or navigating stairs as per PT, she also began to get blurriness of vision. Within 24 hours all symptoms have resolved.
27 2021-04-30 visual impairment Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: F... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild
27 2021-05-01 loss of taste sore arm for a day , loss with sense of taste,
27 2021-05-02 painful gums, mouth pain 4 days following second dose, I wake up with a couple sores near my genitals and later that morning ... Read more
4 days following second dose, I wake up with a couple sores near my genitals and later that morning proceed to feel worse and worse, with intense body aches, chills, and feeling feverish. That night I developed a sore throat and a cough when breathing deeply. The next day felt only slightly better. The days following the body aches, chills, and fever subsided, but pain in my gums and mouth began, and sores around my anus grew worse. In addition there is pain in my chest when I try and eat, a tightness that hurts when I swallow or hiccup. It has now days 7 since my first onset of symptoms and the sores are still painful bit improving, and the mouth pain still as present as ever. Chest pain also still a problem. I've been treating with ibuprofen, diluted tee tree oil and cortisone gel on the sores, and medicated cough drops for my mouth. I've been eating soft foods because of the mouth pain.
27 2021-05-02 lacrimation increased After 13 hours from the shot, I had onset chills and body aches. These lasted for 6 hours. I then ha... Read more
After 13 hours from the shot, I had onset chills and body aches. These lasted for 6 hours. I then had a fever of 101 for the next 6 hours. Throbbing headache came around 18 hours after reviving the shot, my arm was also extremely tender to touch. I took ibuprofen 800mg around hour 20. This helped the headache. I had a racing heart rate through the fever. The symptoms lasted for about 36 hours. Following this, I had onset allergies (stuffy nose, dry cough, difficulty breathing, swollen face, watery eyes). Claritin had helped a little bit and swelling went down.
27 2021-05-02 mouth tingling Immediately after immunization, patient felt dizzy and tingling around mouth. Felt unsteady. Denie... Read more
Immediately after immunization, patient felt dizzy and tingling around mouth. Felt unsteady. Denies shortness of breath, no difficulty swallowing, no LOC. BP-139/90, p-104, O2sat- 99% states she did not eat prior to getting vaccine and she also took her Lexapro late. 12:20 decreased tingling in face and lip, no further dizziness, BP- 125/75, p- 86, O2 sat- 97% Able to stand and walk without difficulty. Discharged home with her mother.
27 2021-05-03 photosensitivity reaction Rash two days post injection. Starting on neck then spread to arms and legs. Blotchy, non raised, re... Read more
Rash two days post injection. Starting on neck then spread to arms and legs. Blotchy, non raised, reddened rash that itched and burned when scratched. Benadryl and cortisone cream used with little help. Oral antihistamine such as Benadryl was effective. Rash would go away and return after 1 or a few hours and show in a different area than previously. In the morning and in the evening worse. Rash would show on eye lids and face as well. Lasted about 2 weeks then resolved on its own. Now skin is more photosensitive and blotchy rash will develop with certain creams or sun exposure without specific sunscreen reapplication
27 2021-05-04 loss of taste, loss of smell New loss of taste or smell Congestion or running nose
27 2021-05-05 loss of taste, loss of smell 2nd day started a fever, cold sweats, hot flashes, body aches 3rd day to 1 week later: loss of taste... Read more
2nd day started a fever, cold sweats, hot flashes, body aches 3rd day to 1 week later: loss of taste and smell, runny nose, foggy brain, 1 to 2 weeks later: nausea and diarrhea during ovulation cycle, spotting between cycles
27 2021-05-05 dry throat, thirst Within 15 minutes: dry throat and warming feeling over my face/flushing I drank water and had a sna... Read more
Within 15 minutes: dry throat and warming feeling over my face/flushing I drank water and had a snack around the 20-25 minute and put on the AC on high in my car in case it was just anxiety. When I took off my mask around then my cheeks were red and a little bit below my chin was red. After I drank water my throat had that lump in your throat type of feeling. I went to my aunt?s house a hour after the vaccine was given and she confirmed my face and neck were unusually red. I was very thirsty and drank a whole water bottle within a hour and a half of the shot. 2 hours after the vaccine I took half a Benadryl and my face started becoming less red and the warmth feeling started going away. My throat was still dry and lump in the throat feeling for the rest of the night. Ricola cough drops helped soothe it a bit though. I took the other half of the Benadryl 4 hours after the last Benadryl and then went to sleep. Today, my throat is still not great but my face redness has gone away. My arm is sore and hurts more the higher I raise it. Going to email my doctor at lunch and try to find an allergist to connect with about whether I can receive the second dose or not.
27 2021-05-06 dry mouth Symptoms occurred in the following order: Soreness in arm, fatigue, body ache, fever, nosebleed, chi... Read more
Symptoms occurred in the following order: Soreness in arm, fatigue, body ache, fever, nosebleed, chills, headache, mouth dryness.
27 2021-05-06 ear discomfort Occasional fullness in both ears, lasts for hours, started one week after the second shot
27 2021-05-06 vision blurred Patient is experiencing ongoing symptoms eight days after the second dose of the vaccine. Symptoms i... Read more
Patient is experiencing ongoing symptoms eight days after the second dose of the vaccine. Symptoms include; -forgetfulness -dizziness -sharp headache as well as back of head and neck pain -nausea -light headed -muscle Spasms -confusion -blurred vision -difficulty understanding what people say at times. -loosing train of thought often -at times dyslexia
27 2021-05-07 mouth swelling Hot flashes, swelling of mouth and throat, fatigue, bloody nose, shaky, nausea, loss of appetite and... Read more
Hot flashes, swelling of mouth and throat, fatigue, bloody nose, shaky, nausea, loss of appetite and taste, achy and pain and nerve aching, migraines
27 2021-05-07 ringing in ears, deafness Ringing/buzzing/echoing in both ears, hearing loss, loss of balance, and dizziness. Symptoms have co... Read more
Ringing/buzzing/echoing in both ears, hearing loss, loss of balance, and dizziness. Symptoms have continued for 48 hours+
27 2021-05-09 dry mouth Within thirty min of shot mouth went dry and couldn?t swallow. Pain at injection 3 hours after shot ... Read more
Within thirty min of shot mouth went dry and couldn?t swallow. Pain at injection 3 hours after shot and next day. Fever of 102 next day for three days and swollen right lymph node above collar bone. Swollen lymph node continued for a week and is still sensitive and slightly swollen a week later.
27 2021-05-10 dry mouth, thirst Severe dry mouth, unquenchable thirst, swollen lymph nodes, hives, headache, sore, burning throat.
27 2021-05-13 deafness A few days after my shot I woke up and lost 80% hearing in my ears, the next two days it improved sl... Read more
A few days after my shot I woke up and lost 80% hearing in my ears, the next two days it improved slightly but now over 10 days after the vaccine I still have not perfect hearing and daily headaches that feel like extreme pressure in my head.
27 2021-05-16 ringing in ears I had COVID for the first week of December of 2020 and around the fourth day of being symptomatic, I... Read more
I had COVID for the first week of December of 2020 and around the fourth day of being symptomatic, I developed tinnitus, which I continued to experience as a low-grade, high-pitched ringing in my ears in the months following. I reported this to a PCP . Immediately after getting my second dose of the Pfizer COVID vaccine, I began experiencing some of the symptoms I had when I had COVID (migraine, low-grade fever) and my tinnitus got much worse. It is now significantly louder and makes it difficult to focus or sleep at night. Nobody seems to know whether or not this will be permanent. If it is, I don?t know what I?m going to do.
27 2021-05-17 mouth numbness I went home and took a nap, when I woke from my nap my right side (injection side) was numb. My fac... Read more
I went home and took a nap, when I woke from my nap my right side (injection side) was numb. My face around my nose was numb down to my waist line. It was like half of my body was asleep, like when your arm or foot goes to sleep, that was the feeling on my right side. Everything was normal on the left side. Woke up the next morning and my migraine started, I kept a migraine for the next 4 days. 3 Days later I started getting feeling back everywhere except my shoulder blade and arm. Once I regained most the feeling I had cramps where I would normally have menstral cramps. Thursday 5/13 I started spotting. It was more of a flow and stopped by Sunday afternoon. as of Tuesday 5/18 my right arm has a little feeling but it comes and goes mainly my upper arm and shoulder are numb still.
27 2021-05-17 mouth tingling tingling of the tongue and side of the mouth w/o swelling or erythema. Treated with 50mg diphenhydr... Read more
tingling of the tongue and side of the mouth w/o swelling or erythema. Treated with 50mg diphenhydramine PO. at 1132 Patient discharged stable w/o new or worsening symptoms 50 minutes after shot time. ER precautions given.
27 2021-05-19 bloodshot eyes First dose as well as second dose of the vaccine was followed by immediate vaginal bleeding which la... Read more
First dose as well as second dose of the vaccine was followed by immediate vaginal bleeding which lasted for a week. Bleeding is still ongoing after the second vaccine shot. A red spot in the eye has appeared without any known reason.
27 2021-05-20 lip swelling She developed shortness of breath, swollen upper lip and tongue tingling within 5 minutes of her fir... Read more
She developed shortness of breath, swollen upper lip and tongue tingling within 5 minutes of her first dose of the Pfizer Covid Vaccine. Sent to the ED for treatment and observation. Released without further incident.
27 2021-05-20 mouth swelling, eye swelling, lip swelling, swollen tongue Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Called EMS ... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Called EMS as soon as swelling in arms started. EMS arrived as patient's lips and tongue started to swell. EMS took her to ER. Unaware if she received epinephrine or diphenhydramine.
27 2021-05-20 swelling of eyelid Symptoms were swollen eyelids and headache in the forehead area. Used Advil and Benadryl for treatme... Read more
Symptoms were swollen eyelids and headache in the forehead area. Used Advil and Benadryl for treatment. Day one swelling subsided by end of day, I only took Advil. Day 2 I woke up and my eyes were swollen again. Took a Benadryl and am now awaiting the outcome.
27 2021-05-22 inability to speak Around February 16th, (4 weeks after second dose of Pfizer) I developed a swollen lymph node on the ... Read more
Around February 16th, (4 weeks after second dose of Pfizer) I developed a swollen lymph node on the left side of the neck just below the jawline. With the swollen lymph nodes came sharp pain when talking or eating. Occasionally with the sharp pain the left side of the neck would swell and I would lose my voice from sometimes up to an hour. Doctor's visit was made and an ultrasound was scheduled. Ultrasound showed two enlarged lymph nodes. Was given a steroid (prednisone 40mg for5 days) and given 8 weeks until a follow up. At follow up the pain is nearly gone but the lymph nodes are still the same swollen size. Blood work was scheduled and all came back normal. Approaching 14 weeks with swollen lymph nodes with no sign of improvement with size of swelling.
27 2021-05-22 bleeding gums Generalized bruising all over the body without injury, bleeding gums, swollen ankles, claudication
27 2021-05-22 hearing loss, eye pain 5/5 Right neck lymph nodes became swollen and painful same evening of vaccination (opposite of injec... Read more
5/5 Right neck lymph nodes became swollen and painful same evening of vaccination (opposite of injection site). Randomly getting muffled ear (as if pressure is unable to equalize), even when I am just sitting down (ongoing). Headache (on and off since) 5/6 Both arms sore (resolved after a week) and upper right back pain along spine (resolved after a day). Temp was 99.5 in armpit (did not recheck until 5/21). 5/7-5/8 Difficulty swallowing (resolved after a day). Eye pain started in left eye especially when looking sideways or up (eventually became both eyes and then mostly the right eye by 5/13. Went to eye doctor and given topical NSAID which resolved eye pain by 5/15) 5/17-5/18 Neck lymph nodes finally became less painful, but still swollen. Pain slowly started again 5/20. 5/21 Woke up with extreme right neck pain equivalent to day of covid vaccination. Went to urgent care in the morning, temp was 99. As I was there, I could feel a headache starting and temperature rising. When I left, they checked again and it was at 100.5. That afternoon, temp continued to rise to 102.2 with chills and splitting headache. Took 200 mg ibuprofen which helped reduce the fever. 5/22 Took a covid swab test in the morning, results came back negative. Neck still painful. At around 9pm, fever started again and went up to 102.5 before I took another ibuprofen 200mg. 5/23 Today, painful and stiff neck but no fever yet.
27 2021-05-23 taste impairment Patient reported new onset dyspnea, dysphagia, and dysgeusia starting several hours after vaccinatio... Read more
Patient reported new onset dyspnea, dysphagia, and dysgeusia starting several hours after vaccination, but in the same day. Patient reached out to me on 5/24/21 reporting that her symptoms were worsening, not improving at that time. Based on her symptoms, I advised she seek medical care. She did not report having a primary care physician.
27 2021-05-24 loss of taste, loss of smell Nasal congestion, cough, sore throat, fever, loss of taste and smell in approximately 50%.
27 2021-05-24 taste impairment I received my 2nd dose of the Pfizer vaccine on 2/21/21 and on 3/9/21 I first noticed a metallic tas... Read more
I received my 2nd dose of the Pfizer vaccine on 2/21/21 and on 3/9/21 I first noticed a metallic taste when eating certain foods. The taste is more prominent in peanut butter cups, diet coke, and many other foods. It has caused me to stop eating/drinking some things and overall has changed my eating experience. It has been 11 weeks since I first noticed this change and it has been consistent the whole time.
27 2021-05-24 mouth numbness Numbness down left arm, mouth felt numb. Started 15 minutes after vaccine, lasted 45 minutes.
27 2021-05-26 ear swelling Pfizer-BioNTech COVID-19 Vaccine EUA: soon after vaccination patient noted swelling of left external... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: soon after vaccination patient noted swelling of left external auditory canal that subsequently drained yellow pus. Later in the day the patient noticed facial swelling. Presents to urgent care with fever, headache, nasal congestion, and sore throat. Diagnosed with cellulitis, prescribed topical and oral antimicrobials, advised to manage pain with NSAIDs.
27 2021-05-26 ringing in ears I have had mild tinnitus for 4 Years. About a week following my first dose of the Pfizer vaccine, my... Read more
I have had mild tinnitus for 4 Years. About a week following my first dose of the Pfizer vaccine, my tinnitus has gotten extremely bad. It is much louder and higher pitched than it ever has been. After my second dose the tinnitus got even worse and is almost unbearable. Now I am almost 2 months post second vaccine and there has been no improvement what's so ever.
27 2021-05-28 eye pain Headache, joint pain, fever, dizziness, nausea, eye pain, abdominal pain, leg pain
27 2021-05-31 eye pain Exactly one week after the second vaccine I developed a severe headache. It was a pulsing in my enti... Read more
Exactly one week after the second vaccine I developed a severe headache. It was a pulsing in my entire forehead and into my eyes. It started the morning of May 25 and I have woken up with the same headache since then. Advil sometimes works but it does not completely reduce the symptoms.
27 2021-05-31 thirst Day 1: pain at injection sight, mild headache, resolved with ibuprofen. Day 2: menstruation occurre... Read more
Day 1: pain at injection sight, mild headache, resolved with ibuprofen. Day 2: menstruation occurred 2 weeks early, moderate bleeding, moderate uterine cramping, muscle pain, severe fatigue. Day 3-5: menstruation continues, moderate bleeding severe fatigue, extreme thirst.
27 2021-06-01 eye movement disorder Patient received vaccine at approximately 3:10PM. After receiving she seemed fine and was able to wa... Read more
Patient received vaccine at approximately 3:10PM. After receiving she seemed fine and was able to walk to the waiting area. After approximately 1-2 minutes she reported to her boyfriend that she did not feel well and "needed some water." Immediately following she began to lose consciousness and went completely limp with her eyes rolled back, according to her boyfriend who caught her and placed her on the ground. The boyfriend also reported some muscle tremors occurring during this. After another minute the patient regained consciousness and was awake and oriented to person and place but not time. She was able to see properly and was vocalizing effectively. 911 was called immediately following initial loss of consciousness and EMS arrived to collect vitals. Patient was given a few sips of water. No medications were given. Following EMS assessment, patient was hypotensive and unable to stand on their own; EMS transported the patient to the emergency department.
27 2021-06-01 bloodshot eyes I ended up giving birth early after my second vaccine dose (first dose of Pfizer was on 3/13/21, sec... Read more
I ended up giving birth early after my second vaccine dose (first dose of Pfizer was on 3/13/21, second dose was on 4/3/21). My expected due date was 9/1/2021. My baby was 23 weeks 6 days when he was born. He weighed 720 grams. My OB diagnosed that I have placental abruption. I ended up having C section. For the first dose of Pfizer vaccine, I have red eye (blood in one of my eyes) and my arm hurt. I only feel my arm hurts after the second dose but then ended up giving birth early.
27 2021-06-01 swelling of eyelid, mouth discomfort I received my first does of Pfizers on 4/15/2021. 2 days later i ate truffle fries and i was having ... Read more
I received my first does of Pfizers on 4/15/2021. 2 days later i ate truffle fries and i was having trouble breathing, my eyelids were swelling up and i was out of breath. A week later I was working at my job again and this time i didn't eat or drink anything out of the norm and i had trouble breathing again and only one eyelid swelled up. In between the first and second shot i would periodically have trouble breathing for a few hours if that. I received my second shot on 5/13/2021. On 5/26/2021 I got lettuce wraps. I ate one lettuce wrap and my lips started to burn when i started eating the second one. By the time i was done with my second lettuce wrap I couldn't breath i instantly stop eating them, chugged water, took and allegra to help my breathing within 45 minutes my whole face was itchy and really red and my whole body was filled with hives from head to toe. I immediately went straight to urgent care, they gave me a steroid shot and a benadryl shot. I waited there for 15 minutes to make sure no reactions happened, thankfully it went away. On 6/1/2021 I was working and around 12:00pm when i went on my lunch break, I had 1 hot dog and the rest of the day I could not breath at all.
27 2021-06-03 eye swelling On June 4th at 12:00am I woke up with my right eye almost swollen shut. I took Benadryl and used ice... Read more
On June 4th at 12:00am I woke up with my right eye almost swollen shut. I took Benadryl and used ice to reduce swelling. Right now it is 12:51pm on June 4th and it is still swollen but it?s better than before I treated it.
27 2021-06-03 sudden hearing loss Sudden hearing loss in right ear
27 2021-06-06 lacrimation increased 22w pregnant, EDD 9/28/21, began having allergy-like symptoms to include runny nose, postnasal drip,... Read more
22w pregnant, EDD 9/28/21, began having allergy-like symptoms to include runny nose, postnasal drip, sore throat, and watery eyes that progressed to a fever, severe congestion, sneezing, malaise, headaches, cold symptoms.
27 2021-06-06 ringing in ears persistent tinnitus in both ears, R>L
27 2021-06-06 enlarged tonsils I went to the Family Care the day after receiving my first dose of the Pfizer vaccine. I was experie... Read more
I went to the Family Care the day after receiving my first dose of the Pfizer vaccine. I was experiencing very sore throat and low grade fever (I believe the highest was 100.1). The symptoms felt similar to times I had strep in the past. I did note that my posterior pharynx, in addition to my tonsils, looked abnormally swollen that morning. I truly thought I had strep but the test was negative. I was also tested for the flu which was negative. Later that week I had a Rapid Covid test at the hospital where I work which was also negative. After my second dose, I had no issues.
27 2021-06-08 inability to speak IMMEDIATLY I BROKE OUT IN HIVES ALL OVER, MY RIGHT ARM SWELLED UP, AND HOT TO THE TOUCH, COULD NOT S... Read more
IMMEDIATLY I BROKE OUT IN HIVES ALL OVER, MY RIGHT ARM SWELLED UP, AND HOT TO THE TOUCH, COULD NOT SWALLOW, AND LOST MY VOICE. IT STARTED CALMING DOWN AN HOUR AFTER I WAS GIVEN STERIODS.
27 2021-06-08 thirst feel very tired; pain at the injection site; feel very thirsty; This is a spontaneous report from a ... Read more
feel very tired; pain at the injection site; feel very thirsty; This is a spontaneous report from a contactable consumer (patient herself). This 27-Year-old female consumer reported for herself that received BNT162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and expiry date Unknown) via an unspecified route of administration in left arm on 08Mar2021 16:30(at the age of 27-years-old) as unknown, single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included depression and anxiety. Patient was allergic to zyrtec, adhesives. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), ethinylestradiol, norgestimate (ESTARYLLA), doxylamine succinate (UNISOM [DOXYLAMINE SUCCINATE]), Ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No other vaccines in 4 weeks. On 09Mar2021 08:15 (Timeframe between vaccine start and event onset date was 15 hrs 45 min) patient experienced feel very tired, some pain at the injection site, and feel very thirsty. Therapeutic measures were not received as a result of adverse events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
27 2021-06-09 ear pain At 8:45am, I woke up with a tight pain in my chest on the left side and pain in my left arm, left si... Read more
At 8:45am, I woke up with a tight pain in my chest on the left side and pain in my left arm, left side of neck and left ear. The pain was severe enough that I considered going to the hospital because I thought I was having a heart attack, but decided not to because I am a healthy and fit 27year old. The pain got more severe. I alternated between laying down while struggling to take deep breaths and stretching because my left neck and arm hurt. I drank about 16oz of water. At around 11am I threw up water. At around 12pm I was able to fall back asleep. When I woke up around 1:30pm I felt much better with just very mild symptoms and by about 4pm I felt completely better. I have had no symptoms since.
27 2021-06-09 ringing in ears I kept a vaccine diary for 8 days after my first Pfizer shot which was in my left arm. The unexpecte... Read more
I kept a vaccine diary for 8 days after my first Pfizer shot which was in my left arm. The unexpected side effects started on the early evening of Day 4, when I felt a headache on the top right side of my skull, extreme dizziness, and ringing in my left ear that lasted for about 3 minutes. On Day 5, I woke up with a ringing that was stronger than the night before and felt too exhausted to raise my arm above my shoulders. On Day 6, I began to felt better even though my neck was stiff and I was still too tired to raise my arm.
27 2021-06-10 vision blurred Stroke; she had blood clots on her brain; headache; her left leg was numb like it was asleep; blurry... Read more
Stroke; she had blood clots on her brain; headache; her left leg was numb like it was asleep; blurry vision; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8736) in left arm via an unknown route of administration on 24Apr2021 at 10:10 (at the age 27-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8727) right arm, via an unknown route of administration on 31Mar2021 as single dose for covid-19 immunization and experienced no adverse event. On 14May2021 at around 07:00 or 08:00, the patient experienced stroke. The patient was hospitalized for stroke from 15May2021 to May2021. On an unknown date, the patient had blood clots on her brain, headache, her left leg was numb like it was asleep, blurry vision. It was reported that patient was recently got her vision back to where she can stand the light long enough to do the research and call around. The stroke happened on 14May2021 and patient went to the hospital on 15May2021 for 5 days because she thought it was just a headache. The patient cannot find the exact date she was discharged. The vision was the first thing that went, then headache started. When patient woke up early in the morning her left leg was numb like it was asleep. Patient used the restroom and did her morning routine, and when she sat back down had the worst headache of her life. They said she had blood clots on her brain. When patient got there, they couldn't stop it because it had already happened and the damage was done. It was reported that patient knew she was going to be travelling and would start working around children. Patient was exposed to a lot of people and thought at the time it was the best thing to go ahead and get the vaccine to go back to a new normal. Patient had bloodwork test and drew so much blood trying to figure out how but results showed unknown. The most common stroke was a blood clot on the brain. Everything matches from the blurry vision to the headaches. Patient declines to report on any of the people she read about, she is just calling to report on herself. The stroke was early because her aunt had a stroke literally the week before and her wake was in the morning. She was getting ready for that. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccines. Patient's lab test included blood work: unknown on an unspecified date. The outcome of the events was unknown. PSCC Communication was as provided contact information for Pfizer Legal Department and report reference number to the caller. Caller declined to complete reports on the people she read about online. Information on Lot/Batch number was available. Additional Information has been requested.
27 2021-06-11 sensitivity to light Tested positive for low von willebrande factor; After 2 dose I started to bruise extremely easily; t... Read more
Tested positive for low von willebrande factor; After 2 dose I started to bruise extremely easily; the migraine like symptoms increased to multiple times per week with extreme sen; extreme sensitivity to light and vomiting; extreme sensitivity to light and vomiting; Cuts that would bleed excessively; Nose bleeds; A 27-year-old (Non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number:ER8727) via unspecified route of administration in left arm on 31Mar2021 13:00 as (at age of 27years) 2nd dose, single dose for COVID-19 Immunization. Patient medical history includes Attention deficit hyperactivity disorder (ADHD), Anxiety from unspecified date and unknown till ongoing. Patient is allergic to the drugs include Penicillin, Omeprazole from unknown date till ongoing. Patient concomitant medications include lisdexamfetamine mesilate(VYVANSE) and drospirenone, ethinylestradiol(GIANVI) used for unspecified indication from unknown date and unknown if ongoing. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6207) via unspecified route of administration in left arm on 11Mar2021 09:00 (at age of 27years) as single dose for COVID-19 Immunization and experienced 1 week after first dose patient began getting severe migraine like symptoms followed by extremely heavy menstrual cycle. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. On unspecified date, after 2 dose patient started to bruise extremely easily and the migraine like symptoms increased to multiple times per week with extreme sensitivity to light and vomiting. Patient had cuts that would bleed excessively, woke up with nose bleeds and tested positive for Low von willebrande factor with no history of any type of bleeding disorder. The adverse events resulted in physician office visit. Patient received treatment for events .Patient underwent lab test and procedures include CT Scan of head, blood tests result was unknown and vonwillebrande was positive . The Clinical outcome of all events was Recovering. Information on the lot/batch number has been requested.
27 2021-06-13 bloodshot eyes Pt presents w/ redness to eye, "spots" to eye area 20 mins after vaccination. No visual disturbance... Read more
Pt presents w/ redness to eye, "spots" to eye area 20 mins after vaccination. No visual disturbances. No respiratory issues. No swelling. NKDA, No PMH or medications. BP 114/74, HR 81, RR 18
27 2021-06-16 taste impairment metallic taste in my mouth; slight tightening of my throat; my throat swelling worsened making it di... Read more
metallic taste in my mouth; slight tightening of my throat; my throat swelling worsened making it difficult to swallow; my throat swelling worsened making it difficult to swallow; slight headache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 27-Year-old Female patient (age at vaccination: 27 year) received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Mar2021 at 13:30 PM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma, environmental allergies and known allergies of chickpeas, pet dander and dust mites (from an unknown date and unknown if ongoing). Concomitant medications included loratadine (CLARITINE); fluticasone propionate (FLONASE) and multivitamins (Vitamins not otherwise specified (NOS)) daily (taken for an unspecified indication, start and stop date were not reported). Patient had no other vaccine in four weeks. It was unknown if patient had COVID prior vaccination. The patient was not tested for covid post vaccination. On 05Mar2021 at 13:35 hours (5 minutes after injection), the experienced a metallic taste in her mouth and a slight tightening of her throat. While in observation, this persisted so she told a nurse and PA on site, they assured her that she was fine if she had no history of severe allergic reactions. She left observation at 25 minutes after injection. Upon driving home about 35-40 minutes later her throat swelling worsened making it difficult to swallow, the metallic taste persisted, and she also had slight headache. She used her Albuterol HFA rescue inhaler. The throat swelling and difficulty swallowing resolved shortly thereafter. The metallic taste and headache persist currently +2 hours after injection. The patient received unknown treatment for the events metallic taste in my mouth and slight headache. The outcome of the events metallic taste in my mouth and slight headache was not resolved and for all other events, it was resolved on 05Mar2021. No follow-up attempts are needed. No further information is expected.
27 2021-06-17 visual impairment Around 5-7 minutes after injection, I started having heart palpitations and visual disturbances that... Read more
Around 5-7 minutes after injection, I started having heart palpitations and visual disturbances that lasted maybe 30 seconds or so
27 2021-06-18 loss of smell, loss of taste Flu like symptoms; Loss of taste and smell; Loss of taste and smell; Sinus pressure and discharge; S... Read more
Flu like symptoms; Loss of taste and smell; Loss of taste and smell; Sinus pressure and discharge; Sinus pressure and discharge; This is a spontaneous report from a contactable consumer (patient). This 27-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14May2021 at 09:00 (at the age of 27-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient previously received dose 1 of BNT162B2 on 23Apr2021 at 09:00 for COVID-19 immunization. On 14May2021 at 19:00 the patient experienced flu-like symptoms, loss of taste and smell, and sinus pressure and discharge. The patient visited a doctor or other healthcare professional office/clinic as a result of the events. The patient received unspecified treatment for the events. The outcomes of flu-like symptoms, loss of taste and smell, and sinus pressure and discharge were unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
27 2021-06-18 eye swelling On Friday June 4th I woke up at 12:00am after going to sleep at 11:pm on June 3rd. When I woke up I ... Read more
On Friday June 4th I woke up at 12:00am after going to sleep at 11:pm on June 3rd. When I woke up I found that my right eye was almost swollen shut. I took Benadryl and used ice to reduce the swelling; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 27-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jun2021 14:30 (Batch/Lot Number: Ew0186) as 1st DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 27 years old. Patient was not pregnant. Medical history reported as no. No known allergies. Concomitant medications included fexofenadine hydrochloride (ALLEGRA ALLERGY) and Excedrine migrane (as reported). Reported Event: On Friday 4th Jun patient woke up at 12:00am after going to sleep at 11:pm on 3Jun. When she woke up she found that her right eye was almost swollen shut. She took Benadryl and used ice to reduce the swelling. It was now 12:38pm on 4Jun and the eye was still a bit swollen but it was better than when she first woke up. The patient experienced the event (serious as medically significant) on 04Jun2021 12:00 AM with outcome of recovering. AE treatment: took Benadryl and used ice to reduce swelling. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Information on Lot/Batch number was available. Additional information has been requested.
27 2021-06-19 inability to speak Arm started feeling really sore where the shot was injected, I then started feeling a very sore th... Read more
Arm started feeling really sore where the shot was injected, I then started feeling a very sore throat, I lost my voice, my stomach ached pretty bad. Over a course of 4 days I noticed the symptoms listed were getting worse. About an hour and a half ago, my symptoms started to go away on their own.
27 2021-06-21 sudden hearing loss, deafness unilateral, permanent deafness, ringing in ears Diagnosed with sudden onset sensorineural hearing loss 11 days after vaccine. Hearing loss in the le... Read more
Diagnosed with sudden onset sensorineural hearing loss 11 days after vaccine. Hearing loss in the left ear in 3 frequencies. Tinnitus in the left year.
27 2021-06-24 lip swelling Swollen lower lips, feeling a sensation of numbness and burn.; feeling a sensation of numbness; feel... Read more
Swollen lower lips, feeling a sensation of numbness and burn.; feeling a sensation of numbness; feeling a sensation of burn; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration on 18Mar2021 at 13:30 in left arm for COVID-19 immunisation. Medical history of the patient included chronic pelvic pain and endometriosis. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration on 25Feb2021 at 11:00 in left arm for COVID-19 immunisation. The patient had no allergies to medication, food or other products. The patient did not receive any other vaccine within 4 weeks of receiving COVID-19 vaccine. The patient did not have COVID-19 test prior to vaccination. The patient was not tested positive for COVID-19 since having the vaccination. The patient experienced swollen lower lips, feeling of a sensation of numbness and burn on 19Mar2021. Therapeutic measures taken as a result of events included unknown medication for allergies prior to vaccination. The clinical outcome of swollen lower lips, feeling a sensation of numbness and burn was not recovered. No follow-up attempts are needed. No further information is expected.
27 2021-06-30 eye swelling, lip swelling Roughly 5 weeks after the second dose of the Pfizer\BioNTech vaccine, patient caught Covid. During t... Read more
Roughly 5 weeks after the second dose of the Pfizer\BioNTech vaccine, patient caught Covid. During the first few (3-4) days symptoms were mild and limited to shortness of breath and being easily tired. After a number of days with symptoms, patient continued feeling worse and worse. Around the 4th day of symptoms patient's face (eyes, lips, lymph nodes, throat) began to swell which prompted a visit to the ER. Once admitted, patient spent 9 days in the hospital as she moved towards a stable condition. Upon further investigation and visits with multiple specialists, a dermatologist concluded this was a case of Stevens-Johnson syndrome which may have been brought on due to vaccine (and suggested contacting CDC about this case as to his knowledge this has yet to be documented).
27 2021-06-30 vision blurred, eye twitching, visual impairment vision went blurry; Dizzy/Light-headed; weird sensations in different parts of her head; hands and l... Read more
vision went blurry; Dizzy/Light-headed; weird sensations in different parts of her head; hands and legs went weak; vision was so bad.; left eye twitching; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, solution for injection, lot number: EW0176) via unknown route of administration on 30Apr2021 at dose 1 single in deltoid left (left shoulder as reported) for COVID-19 immunisation. Medical history included lyme disease (since she was young, weakened immune system), bartonella (since she was young, weakened immune system), anaemia (several years), vitamin D low (several years), interstitial cystitis (10 years) all are ongoing. Concomitant medications were not reported. Then 1-2 min after her vision went blurry. She was dizzy, and light-headed. She felt weird in different parts of her head. She was like having weird sensations in different parts of her head. One second it would be in her forehead and then in the back of her head. It was weird. That occurred on 30Apr2021 but went away that same day. Her hands and legs went weak. That happened on 30Apr2021, just that day and she recovered. All the side effects subsided after several hours except for the blurred vision. Her vision was still blurry. Her left eye was also twitching which has started since the vaccine in 2021. She didn't have eye twitching before, but she thinks that was less frequent now. She went to the Ophthalmologist, and he did an eye exam with unknown results. That was 3 weeks ago in 2021. Her last eye exam was 8 years ago with unknown results. But he said that her vision change since that exam was extremely significant. It was now illegal for her to drive her vision was so bad in 2021. Her doctor was not sure what happened either. Her doctor was now referring her to a Neuro-ophthalmologist. She has been taking Vitamins to try to help. She has been taking Vitamin D3 and iron. She does have chronic Lyme disease and Bartonella because of that she does have a weakened immune system. She has had both of those since she was little. She was a lot better now. She was not as sick anymore from those. She was not going to get the second dose. She was wondering if she can reverse the blurry vision. she asked her doctor about the Lyme disease, and her vision change. The doctor said she needed to report this to Pfizer. If it was because of the Lyme disease it would have happened before the vaccine. The outcome of event vision blurred was not recovered, vision abnormal was unknown, eyelid twitching was recovering and remaining were recovered on 30Apr2021. Information on the batch number has been requested.
27 2021-07-02 ear discomfort, ringing in ears After my first dose, I started feeling left head pressure kind of dull pain on the same day. Then it... Read more
After my first dose, I started feeling left head pressure kind of dull pain on the same day. Then it gradually increased and I met my primary care provider with series of visits. Have taken ibuprofen and other pain relievers for days. But there were no improvements. On Apr 17 I went to the emergency room for treating the unknown problems. They have taken MRI, CT everything came negative. After a month another symptom kicked in. Which caused my ear popping and clicking and buzzing sounds. Again we visited our primary care doctor and ENt, dentist. ENT was suspected I may have inflammation and have TMJ. Then they asked us to take MRi with our own pocket money. mRI RESULT again came negative. Currently I am having still ear popping and clicking buzzing sounds. I don't know what is going on my health after the vaccine. We are still following up with ENT doctor.
27 2021-07-08 loss of taste, loss of smell she had her first vaccine dose and afterwards she tested positive for covid; cough; headache; fever;... Read more
she had her first vaccine dose and afterwards she tested positive for covid; cough; headache; fever; temporarily lost her sense of taste and smell; temporarily lost her sense of taste and smell; congestion; This is a spontaneous report from a contactable other hcp. A 27-years-old female nurse (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206; Expiry Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 14:30 (age at vaccination: 27 years) as dose 1, single for Prevention. The patient medical history was not reported. The patient Concomitant medications were not reported. The patient has not received other vaccines on same date with the Pfizer vaccine. The patient received no vaccine within 4 weeks of the current vaccination. No adverse events was reported following prior vaccinations. The patient was a non-smoker. The patient was not taking any medications routinely prior to the event being reported. On 15Mar2021, the patient experienced she had her first vaccine dose and afterwards she tested positive for covid. On 14Mar2021 the patient experienced cough, headache, fever, temporarily lost her sense of taste and smell, congestion. Vaccine was not Administered at Military Facility. The adverse event did not cause visit to emergency room or physician office. The patient was not hospitalized. There were predisposing factors. culture was not performed. It was unknown if the patient had SARS-CoV2 antibodies at diagnosis. The patient was not admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The event did not require the initiation of new medication or other treatment or procedure. It was unknown how many days from the SARS-CoV2 diagnosis did it take before the SARS-CoV2 antigen test became negative. It was not applicable if preexisting diseases worsened during the SARS-CoV2 infection. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. There was a Product Complaint. It was reported that the patient had her first vaccine dose and afterwards she tested positive for covid. She was tested for the Covid 19 virus with the PCR test on Monday 15Mar2021, the results came back positive on Wednesday 17Mar2021. She does the Covid 19 PCR testing as part of her job. She gets tested for Covid 19 twice weekly herself. Before getting the positive Covid 19 results she stated she has been tested for the Covid 19 virus about 40 times with the Covid PCR test. She had a cough, headache, fever, and temporarily lost her sense of taste and smell. She believes losing her taste and smell is more related to her congestion. Her symptoms began on Sunday, 14Mar2021. She reports her symptoms have improved greatly. She barely has a cough anymore. Her taste and smell have come back. She has a slight cough, a dry cough but that should be gone by the weekend. She would say she has recovered. Having the Covid 19 virus never felt unmanageable to her. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Mar2021. The patient did not receive any additional therapies for COVID-19. Outcome of the events were recovered on an unspecified date in 2021. The Source of assessment was reported as Primary Source Reporter and Method of assessment as Global Introspection and drug result was reported as unrelated. Follow-up (24Mar2021): This is a follow-up spontaneous report from a Pfizer sponsored Program CO-VAX US Support. It was reported that the second dose was scheduled on 01Apr2021. Follow-up (26Mar2021): This is a follow-up spontaneous report from a Pfizer sponsored Program CO-VAX US Support. No new information was updated. Follow-up (02Apr2021): This follow-up contains no new medically significant information. No follow up attempts are possible. No further information is expected.
27 2021-07-08 lip swelling, lip pain Numbness/tingling in fingers; Back pain; Numbness and tingling on side of face; headaches; lips feel... Read more
Numbness/tingling in fingers; Back pain; Numbness and tingling on side of face; headaches; lips feeling sore; lips feeling swollen; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206) via an unspecified route of administration in the left arm on 11Mar2021 at 14:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history was not available. The patient had BACTRIM allergy. Concomitant medication included womens daily gummy multi vitamin. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 14:45, the patient experienced numbness or tingling in fingers immediately after vaccine. On an unknown date in Mar2021, the patient experienced numbness and tingling on side of face over past few weeks (mild) that was increasing but still had control of facial movement and also intermittent back pain but was still able to continue exercising routine most days. In week one, in Mar2021, the patient experienced headaches intermittently and week 2.5, she had lips feeling sore and swollen. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events numbness/tingling in fingers, back pain, numbness and tingling on side of face, headaches, lips feeling sore and lips feeling swollen was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
27 2021-07-11 mouth tingling, mouth itchiness, mouth lesion, feeling of choking I experienced itching and tingling in my mouth, throat and ears. A red rash could be seen on the roo... Read more
I experienced itching and tingling in my mouth, throat and ears. A red rash could be seen on the roof of my mouth down my throat. This has happened three times since getting the shot and I have never experienced this before. Symptoms resolved with benadryl.
27 2021-07-12 lip swelling Hours after the second dose my lips started swelling I started to feel extremely ill and extreme bod... Read more
Hours after the second dose my lips started swelling I started to feel extremely ill and extreme body pain and spasms throughout my entire body for the following three days by the fourth day I could not walk or stand and had no strength in my body at all I was it admitted To the hospital April 8 after not being able to walk they started testing and found nothing at all they released me the 10th of April told me to follow up with a neurologist It got to the 12th my legs were even worse than onset I could not get into a neurologist they were booked for months and I was told to go back to the hospital so I went back to hospital and was fast tracked and admitted once again they wanted to rule out Gian beret syndrome they did a spinal tap everything came back negative and six different MRIs of my entire back neck head entire body x-rays everything came back normal I was released once again and told to follow up again with doctors and to do PT. I followed up with neurologist to do an EMG which she started And was unable to finish because she did not have the proper needles she did not understand why I was walking the way I was in unable to keep myself up and showed no interest in my case even though I came in with two pages of information that I had been through in the month in which everything happened. I reported everything to Pfizer in the month of April after my primary care physician told me I needed to report it to Pfizer I waited on the phone an hour to get through to someone reported it talk to someone for maybe 20 minutes and she said I?m so sorry you?re showing adverse effects have a nice day and hung up and I?ve never heard anything again and my doctors never reached out to like they thought they would be after reporting it I go to physical therapy two times a week and get regular blood test because I have an extremely elevated CRP and speckled blood pattern now that was never seen prior to receiving the Covid vaccine I am in extreme agony throughout my entire body every day all day I have extreme weakness of my limbs especially my legs in which I cannot walk properly or hold myself up or walk distances any longer and have been out of work since the day of the vaccine because of this the pain is agony that does not stop I have been given multiple medication?s to try and control help or calm down my auto immune system but nothing works. I have been working with a rheumatologist for the last two months on different medication?s to try and figure out the pain And what is wrong And was diagnosed with suspected fibromyalgia
27 2021-07-12 mouth pain About 4 days after my vaccine, 07/04/2021, my mouth just hurt, really bad at 1st. I was unable to e... Read more
About 4 days after my vaccine, 07/04/2021, my mouth just hurt, really bad at 1st. I was unable to eat solid food for like a week and a half. Then I developed a sore throat and it was really swollen and red, but like spots that were swollen. I still have the sore throat as of today, 07/13/2021, my throat is still swollen and the spots kind a red and white. Dr. believes it was ulcer that were a side effect of the vaccine. She told me to wait it out and take Tylenol. No, I have not recovered because I still have swelling, redness and white spot, It's just less painful, as of last week.
27 2021-07-17 mouth tingling, pain in jaw After second dose I have really bad headaches; Lips tingling/Tongue tingling; My eye starts drifting... Read more
After second dose I have really bad headaches; Lips tingling/Tongue tingling; My eye starts drifting up or twitching when I try to chew,; Jaw pain; Have pain in my chest; Dysphasia; Can't eat food gets stuck; Tingling feet and hands; Burning in legs; Pain in neck and back; Pain in neck and back; Shortness of breath; Fatigue; Weakness in body; Stomach pain; Trouble sleeping; Brain fog; Dizziness; Depersonalization; Feels like spasms; Feels like whole in my chest; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07May2021 08:00 (Batch/Lot number was not reported) as dose 2, single (age at vaccination 27-year-old) for covid-19 immunisation. Medical history included, known allergies: Codeine, cinnamon, latex from an unknown date. Concomitant medication(s) included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 10Apr2021, administration site (right arm), administered at 10:00 AM (age at vaccination 27-year-old) for COVID-19 immunization experienced Leg pain, Fatigue and Weakness. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 12May2021 12:00, the patient experienced after second dose i have really bad headaches, lips tingling/tongue tingling, my eye starts drifting up or twitching when i try to chew, jaw pain, have pain in my chest, dysphasia, can't eat food gets stuck, tingling feet and hands, burning in legs, pain in neck and back, pain in neck and back, shortness of breath, fatigue, weakness in body, stomach pain, trouble sleeping, brain fog, dizziness, depersonalization, feels like spasms. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 04Jun2021. The patient not received treatment for events. The patient visited to emergency room visit/ physician's office for the events. The outcome for all events was not recovered. Information about batch/lot number has been requested.
27 2021-07-17 vision blurred got blurry, unfocused vision; felt spacey/confused; felt spacey/confused; This is a spontaneous repo... Read more
got blurry, unfocused vision; felt spacey/confused; felt spacey/confused; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EWO187), at the age of 27 years old, in left arm on 09Jun2021 at 13:00 at single dose for COVID-19 immunisation. Medical history included known allergies: lactose intolerance. The patient was not pregnant at time of vaccination. It was unknown that the patient was diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Immediately after vaccine the patient got blurry, unfocused vision on 09Jun2021 at 13:15 for a week. The patient also felt spacey/confused immediately after the shot on 09Jun2021 at 13:15 and that continued for about 1 week as well. The patient had not been tested for COVID-19 since the vaccination. No treatment received. The outcome of all events was recovered. No follow-up attempts are possible. No further information is expected.
27 2021-07-17 vision blurred Rapid heartbeat; Spotty vision; Shortness of breath; This is a spontaneous report from a contactable... Read more
Rapid heartbeat; Spotty vision; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021 at 13:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included heart palpitations. The patient was allergic to past drugs acetaminophen (MANUFACTURER UNKNOWN) and montelukast sodium (SINGULAIR). Concomitant medications included propranolol (80mg) (MANUFACTURER UNKNOWN) and lisdexamfetamine mesilate (VYVANSE) (50mg) and an unspecified birth control medication (MANUFACTURER UNKNOWN), all from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Mar2021 at 14:30, the patient experienced rapid heartbeat, spotty vision, and shortness of breath. It was reported that all symptoms were mild. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of rapid heartbeat, spotty vision and shortness of breath was unknown. No follow-up attempts are needed; information about lot number cannot be obtained.
27 2021-07-19 loss of smell, loss of taste COVID Positive 7/18, congestion, cough, loss of taste and smell
27 2021-07-21 eye swelling, swollen tongue, swelling of eyelid, mouth swelling, eye pain Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: EYE PAIN NE... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: EYE PAIN NEXT MORNING. THURSDAY MORNING EYE SWOLLEN SHUT. DOCTOR SUGGESTED BENADRYL AND MONITORING. PATIENT WILL MONITOR AND FOLLOW-UP WITH PHYSICIAN AND PHARMACY.
27 2021-07-21 fluid in middle ear, ringing in ears Severe vertigo, ringing in the ears, nausea, fatigue. First episode lasted 2-3 days, second episode ... Read more
Severe vertigo, ringing in the ears, nausea, fatigue. First episode lasted 2-3 days, second episode began 7/19/21 at 11:30pm and lasted 48 hours.
27 2021-07-22 loss of taste, loss of smell COUGH,RUNNY NOSE,LOSS OF TASTE AND SMELL,SORE THROAT,MUSCLE ACHES,FEVER,HEADACHE,FATIGUE
27 2021-07-22 mouth itchiness couldn't sleep; a lot of itching in throat and mouth; a lot of itching in throat and mouth; This is ... Read more
couldn't sleep; a lot of itching in throat and mouth; a lot of itching in throat and mouth; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number was not reported), via an unspecified route of administration, administered in Arm Left at the age of 27-year-old on 07Jul2021 16:15 as single dose for covid-19 immunization. Medical history included Biotin, Y cranberry's from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration on an unknown date as single dose for covid-19 immunization. On 07Jul2021 23:45, at night after receiving the second dose of the vaccine the patient almost couldn't sleep, with a lot of itching in throat and mouth. She would like to know if that event was normal. The patient did not receive treatment for the events. The clinical outcome of events was recovering. Information on the lot/batch number has been requested.
27 2021-07-26 eye movement disorder, mouth tingling Within minutes of receiving vaccine, eyes fluttered, skin color became pale, pt stated she felt ?fun... Read more
Within minutes of receiving vaccine, eyes fluttered, skin color became pale, pt stated she felt ?funny?. Complained of lips tingling, cold packs applied to back of neck and forehead. Approximately 5 min later appeared to ?dry heave?, spit up clear mucus, small amount. Pt was eased to floor and legs raised on chair. B/P monitored, radial pulse remained even 72 BPM. C/o tingling L hand, intermittent. Pt took several attempts to sit up. Light headedness would return, pale, nausea with dry heave. After continued rest for approximately 20 min, color returned to face, tingling resolved, able to sit up, stand, walk, stating ?I feel better now?. Took sips of water throughout episode. Was to leave work accompanied by coworker. Advised not to drive. Going home; mother at home.
27 2021-07-26 lip itchiness Patient reported feeling numbness in arm, generalized itching all over body, dizziness. Patient was ... Read more
Patient reported feeling numbness in arm, generalized itching all over body, dizziness. Patient was given (2) Diphenhydramine 25 mg tablets and water. EMS was contacted due to numbness and generalized itching including the lips. EMS arrived worked up the patient and determined the patient was doing well after approx. 30 minutes. The patient declined going to the hospital for further follow-up.
27 2021-07-27 eye irritation Allergic reaction (non-life threatening) where I had itchy eyes, nose, throat, and neck; Allergic re... Read more
Allergic reaction (non-life threatening) where I had itchy eyes, nose, throat, and neck; Allergic reaction (non-life threatening) where the patient had itchy eyes, nose, throat, and neck; eyes were burning; felt very hot; soreness in the right arm (where the shot was given); This is a spontaneous report from a contactable other healthcare professional. A 27-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3248) via an unspecified route of administration in the arm right on 27Apr2021 at 10:00(at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient's past drug included stone fruit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021, about 2 hours after the vaccination, the patient experienced soreness in the right arm (where the shot was given) which continued for another 48 hours. On 29Apr2021 at 09:00, the patient experienced an allergic reaction (non-life threatening) where she had itchy eyes, nose, throat, and neck and her eyes were burning and felt very hot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL and ALLEGRA. The clinical outcome of the events vaccination site pain, allergic reaction, burning eyes, feeling hot and itchy was resolving. No follow-up attempts are needed. No further information is expected.
27 2021-07-28 lip swelling, eye swelling 7/27/2021 @ 9:00pm broke out in hives, swollen lips & eyes, tight chest, short of breath. Took Benad... Read more
7/27/2021 @ 9:00pm broke out in hives, swollen lips & eyes, tight chest, short of breath. Took Benadryl for treatment. 7/28/2021 @ 10:30am broke out in hives. Took Benadryl for treatment. 7/29/2021 @ 03:00am broke out in hives. Took Benadryl. 7/29/2021 @ 12:30pm woke up with palpitations and shaking. No treatment. Called employee health to let them know to document my reactions. I was told by employee health @12:38pm to follow up with my PCP if this continues or worsens.
28 2020-12-31 swollen tongue tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. ... Read more
tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. Given Benadryl IV and NaCl. Pt in the ER about 2.5 hours.
28 2021-01-02 swollen tongue S: At 1557 patient c/o tongue swelling and itchiness. Given 25mg PO benadryl at 1557   O: Patient a... Read more
S: At 1557 patient c/o tongue swelling and itchiness. Given 25mg PO benadryl at 1557   O: Patient alert and oriented, airway patent. BP 129/88 HR 74 O2 98% 1617 Repeat O2 sat 98% HR 59. Patient c/o persistent tongue swelling.   A/P: 28 F with history of nut allergy with tongue swelling after Pfizer vaccine. EMS notified 1620. Patient evaluated by EMS and declined further treatment by EMS and stated that she would walk over to ED for further evaluation.
28 2021-01-03 lip swelling 36 hours after vaccine my face started swelling rapidly. I had extreme swelling and hardening in the... Read more
36 hours after vaccine my face started swelling rapidly. I had extreme swelling and hardening in the areas where I have HA fillers - lips and tear troughs. Both Restylane products. Ended up going to the ER at 2 AM and receiving angioedema/anaphylaxis protocol. IV benedryl, famotidine, and solumedrol. Was put on prednisone and hydroxyzine for at home care for the next 3 days after event. Swelling went down by the next afternoon.
28 2021-01-03 swollen tongue Patient developed SOB, wheezing, tongue swelling, facial tingling.
28 2021-01-04 eye itchiness About 30-35 mins, after vax, I started noticing my eyes were itching, and I started scratching my fa... Read more
About 30-35 mins, after vax, I started noticing my eyes were itching, and I started scratching my face. I got in my car and realized it's not going away. I need advice on what to take for it to go away. I noticed a itchy throat. Not sure if it's something that's due to the vaccine.
28 2021-01-04 lacrimation increased About 1 hour after the vaccine, I developed watery eyes, itchy, runny nose, sneezing, itchy throat. ... Read more
About 1 hour after the vaccine, I developed watery eyes, itchy, runny nose, sneezing, itchy throat. This lasted throughout the day and required 50mg of Benadryl before symptoms finally subsided around 9pm that night.
28 2021-01-05 ear swelling Heart rate went to 133 at 12:45pm for 6 minutes; face and ears were swollen; face and ears were swol... Read more
Heart rate went to 133 at 12:45pm for 6 minutes; face and ears were swollen; face and ears were swollen; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration at the left arm on 29Dec2020 11:15 at a single dose for COVID-19 immunization. The patient was obese with BMI of 32, known allergies were tree nuts, sunflower seeds sesame seeds. The patient was not pregnant at the time of vaccination. Concomitant medication includes vitamins nos (DAILY MULTIVITAMIN). On 29Dec2020, heart rate went to 133 at 12:45pm for 6 minutes. The patient took TYLENOL and BENADRYL and went to sleep. When she woke up her face and ears were swollen, heart rate is back to normal (29Dec2020). The patient also added that swelling was a reaction she normally gets when she eats something she was allergic too. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events face and ears were swollen was recovering; heart rate went to 133 at 12:45pm for 6 minutes recovered on 29Dec2020.
28 2021-01-05 vision blurred I received my vaccine at 1215 on 12/31/20. At 1800 on 12/31/20 I began to feel mild shortness of br... Read more
I received my vaccine at 1215 on 12/31/20. At 1800 on 12/31/20 I began to feel mild shortness of breath. I then became dizzy at 1805. At 1815 I developed blurred vision. The dizziness and blurred vision prevented me from standing. I was able to walk with assistance at 1915. The blurred vision lasted until 1915. The dizziness lasted until 2230. At 2000 I had muscle aches and joint pain and could not get comfortable. Muscle aches and joint pain lasted until 1-1-21 at 1930. I did not seek medical treatment. (I working in the ER and did not feel it was severe enough to check in because the shortness of breath was mild and went away shortly after the dizziness began at 1815). I took Benadryl 50 mg at 1930 and 1000mg of Tylenol.
28 2021-01-06 blindness After receiving vaccine, woke up around 3 am experiencing nausea, loss of vision x 1-2 minutes, sync... Read more
After receiving vaccine, woke up around 3 am experiencing nausea, loss of vision x 1-2 minutes, syncope, difficulty breathing, numbness & tingling in hands and feet. Measured temperature of 102 F. Slept most of the next day and missed work x 1 day. The following day was improved but still with moderate fatigue and nausea. Took ibuprofen with some improvement.
28 2021-01-06 mouth numbness Perioral numbness Lump in throat Difficult swallowing
28 2021-01-07 mouth itchiness, lip swelling Symptoms started around midnight on 1/7/2021 Symtpoms: Burning red face, entire body was itchy, tong... Read more
Symptoms started around midnight on 1/7/2021 Symtpoms: Burning red face, entire body was itchy, tongue and inside of the mouth was itchy, rash on upper body and swollen inflamed painful lips.
28 2021-01-07 vision blurred Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; ... Read more
Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; This is a spontaneous report from a contactable nurse. A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number= ELO140, via an unspecified route of administration, in the right arm, on 31Dec2020 at 13:45 (at the age of 28 years-old) as a single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included polycystic ovarian syndrome. There were no concomitant medications. The patient had not received other vaccines in 4 weeks nor taken any other medications in 2 weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. On 01Jan2021 at 0700 the patient experienced hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The clinical course was as follows: Sudden development of hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The vision blurring and hot flashes resolved within 15-20 minutes but the fatigue, headache and nausea persisted throughout the day. The patient was not hospitalized for the event nor was treatment administered. The clinical outcome of the hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. Since the vaccination, the patient has not been tested for COVID-19.
28 2021-01-08 eye pain Joint aching. Muscle aching. 7/10 headache behind eyes. Chills. Fatigue.
28 2021-01-08 vision blurred Dizzy, lightheaded, vertigo, nausea, vision out of focus, unable to walk straight and have to stabil... Read more
Dizzy, lightheaded, vertigo, nausea, vision out of focus, unable to walk straight and have to stabilize myself on the wall. I have had 6 episodes lasting 3-24 hours. It has been over 2 weeks (since 12/26/2020 - now).
28 2021-01-10 loss of taste I woke up with chills and diarrhea . I started to sweat out of no where but I didn't have a fever, t... Read more
I woke up with chills and diarrhea . I started to sweat out of no where but I didn't have a fever, towards the end of the night I lost my taste for the next two days. I still had chills and was sweaty, I believe the second day I had a sore throat. My boss sent me to get a Covid test and that came back negative.
28 2021-01-11 loss of taste, loss of smell Flu-like symptoms; Cold symptoms; tested positive for SARS-COV-2 infection; tested positive for SARS... Read more
Flu-like symptoms; Cold symptoms; tested positive for SARS-COV-2 infection; tested positive for SARS-COV-2 infection; muscle and body aches; muscle and body aches; loss sense of taste; Congestion nasal; Sore throat; Loss of smell; Sinus pressure; Headache; general fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EJ1685, via an unspecified route of administration on 17Dec2020 16:00 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient got the COVID Vaccine and the day after, was exposed to the virus, got sick right away and tested positive for the virus. The patient stated that she got vaccinated around 4pm, 17Dec2020. She was exposed to the virus by the same coworker twice on 18Dec2020 and then the next week, she believed, on 22Dec2020, the coworker tested positive for COVID. Patient stated that her symptoms started 24Dec2020. She did not think she had a fever as she did not feel feverish. She had flu like symptoms from an unspecified date with muscle and body aches from 25Dec2020. She lost her sense of taste and smell from 25Dec2020. She had cold-like symptoms from an unspecified date with congestion nasal and sore throat from 25Dec2020, sinus pressure and headaches from 24Dec2020. She had general fatigue from 24Dec2020 for a while. Patient had not had another COVID test since the one she had 28Dec2020, when she tested positive for COVID. She became symptoms-free on 03Jan2021. Patient was asking should she still get the 2nd dose of the COVID Vaccine. She was also concerned about the reaction her body was going to have to the vaccine after being sick. The patient had recovered from Flu-like symptoms and Cold symptoms on an unspecified date, recovered from muscle and body aches on 29Dec2020, recovered from loss sense of taste and loss of smell on 31Dec2020, recovered from congestion nasal, sinus pressure and headache on 03Jan2021, recovered from Sore throat on 01Jan2021, recovered from general fatigue on 02Jan2021. And outcome of "tested positive for COVID after receiving the COVID Vaccine" was unknown.
28 2021-01-12 mouth numbness Systemic: dizziness,lump in throat, difficulty swallowing, numbness of lip area; symptoms lasted 0 d... Read more
Systemic: dizziness,lump in throat, difficulty swallowing, numbness of lip area; symptoms lasted 0 days
28 2021-01-13 eye swelling Developed a rash around my neck and swollen eyes (thought to be poison ivy) on 1/3/2021. Since that ... Read more
Developed a rash around my neck and swollen eyes (thought to be poison ivy) on 1/3/2021. Since that time, the rash has spread to my back, abdomen, chest, neck, ears. It appears to be urticaria and is extremely itchy. I completed a steroid taper early on and the rash is no loner affecting my face. I am taking daily antihistamines and using hydrocortisone cream for the itching. The rash continues to spread and is made worse with scratching. I am unsure if this is related to the vaccine, but this has never happened before and I have no known allergies. I got the second vaccine on 1/8/2021 (at the time the rash was improving and I thought it to be poison ivy).
28 2021-01-13 mouth tingling Patient began itching on chest and showing hives on upper arms. Patient then was learing throat, cou... Read more
Patient began itching on chest and showing hives on upper arms. Patient then was learing throat, coughing, tingling in the tongue. Itchiness progressed down arms, as did hives. EMS arrived and administered 0.3 mg Epi IM and IV Benadryl. Vitals obtained.
28 2021-01-14 lip swelling Hours after first COVID vaccine 12/18 developed facial and lip swelling then urticaria on arms and n... Read more
Hours after first COVID vaccine 12/18 developed facial and lip swelling then urticaria on arms and nonpruritic, erythematous rash chest to thighs. Woke that night with tachycardia to 220's. Tachycardia of varying degree and severe diaphoresis was constant through the next 72 hours. Did not seek care. Since then, for 3 weeks she has had multiple runs of SVT. Last one was Saturday 1/9 - went to ER, episode recorded. Given rx of xanax which did not resolve her tachycardia. Established care with me 1/14/2021 and noted to have 3/6 systolic murmur. Patient (who is a PA) states it is significantly louder than it was prior to vaccination. Given rx of prn propranolol for home, outcome pending
28 2021-01-14 tongue itchiness, swollen tongue covid: vaccination clinic S: At 1557 patient c/o tongue swelling and itchiness. Given 25mg PO benadr... Read more
covid: vaccination clinic S: At 1557 patient c/o tongue swelling and itchiness. Given 25mg PO benadryl at 1557 O: Patient alert and oriented, airway patent. BP 129/88 HR 74 O2 98% 1617 Repeat O2 sat 98% HR 59. Patient c/o persistent tongue swelling. A/P: 28 F with history of nut allergy with tongue swelling after Pfizer vaccine. EMS notified 1620. Patient evaluated by EMS and declined further treatment by EMS and stated that she would walk over to ED for further evaluation. Further return to ED precautions discussed with patient.
28 2021-01-17 dry mouth Chills, Racing Heart, Dry Mouth,
28 2021-01-17 ear pain I received the dose at 12:00pm Saturday and by midnight I was awoken with severe 9/10 pain to my lef... Read more
I received the dose at 12:00pm Saturday and by midnight I was awoken with severe 9/10 pain to my left arm radiating up my left side of my kneck to my ear and down to the middle of my back. This follows Sunday morning with muscle aches, joint pain, headache and nausea. Continuous nausea occurs until vomiting starts sunday mid afternoon. This all continues until Tuesday morning when a Phenergan shot IM is able to be administered at urgent care where I return home and sleep for 24 hours. Tiredness and weakness continue until the morning of Saturday 16th where I wake up feeling "normal" in a sense.
28 2021-01-17 mouth tingling, thirst After almost 15 minutes of receiving vaccine, my mouth, inside and outside, tongue and face wer very... Read more
After almost 15 minutes of receiving vaccine, my mouth, inside and outside, tongue and face wer very tingly and cold. It came from no where. I could even feel it on the top of my mouth. I did not have any trouble breathing or swallowing, it felts like everything fell asleep and that I chugged ice cold water. It lasted for about 40 minutes.
28 2021-01-18 ear pain headache fever sore on mouth swollen face eyes puffy stomach pain ear pain don't feel normal itchy
28 2021-01-18 sensitivity to light Woke up the morning after the vaccine with dizziness, nauseous, dull headache, sensitivity to light/... Read more
Woke up the morning after the vaccine with dizziness, nauseous, dull headache, sensitivity to light/sun. Feeling some pain at injection site and is similar to the first vaccine in the series. Has not yet taken any meds to alleviate the reactions; but will take Advil. After the first injection, patient mainly had injection site pain, but no other adverse reactions. Has not contacted doctor regarding reaction, but is not going in to work.
28 2021-01-18 swollen tongue Pt. described feeling as if her cheeks and front of tongue were slightly swollen. She also noted tin... Read more
Pt. described feeling as if her cheeks and front of tongue were slightly swollen. She also noted tingling of lower legs. She denied any throat tightening, no trouble swallowing or difficulty breathing, no chest tightness as she has experienced in exercise induced asthma. (Note: forgot to add under chronic conditions with only rare use of rescue inhaler).
28 2021-01-20 swollen tongue Systemic: Swelling of tongue and throat; symptoms lasted 1 day
28 2021-01-21 dry mouth Pfizer-BioNTech COVID-19 Vaccine EUA Developed rash that spread over chest, back and left arm after ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Developed rash that spread over chest, back and left arm after vaccine given. Patient also noticed stiffness in neck, feeling of pins and needles and some skin burning. Additionally endorses feeling a dry mouth sensation.
28 2021-01-21 dry mouth Patient had difficulty swallowing and dry mouth. Was given Epinephrine, Benadryl, and Fomotodine and... Read more
Patient had difficulty swallowing and dry mouth. Was given Epinephrine, Benadryl, and Fomotodine and transported from the clinic site the Emergency Room. The effects subsided after 2.5 hours, approximately 10 pm. Observed in the ER for 4 hours.
28 2021-01-21 mouth numbness Patient experienced left facial and tongue numbness which impacted her ability to speak clearly (sim... Read more
Patient experienced left facial and tongue numbness which impacted her ability to speak clearly (similar to numbness experienced with numbing prior to a dental procedure). She was given 25mg diphenhydramine orally and taken to the ER. She was given 10mg dexamethasone intramuscularly in the ER.
28 2021-01-21 mouth numbness One hour after vaccination patient experienced Left facial and tongue numbness that impacted her abi... Read more
One hour after vaccination patient experienced Left facial and tongue numbness that impacted her ability to speak clearly (similar to experience with numbing for a dental procedure). She was given 25mg diphenhydramine orally and taken to the ER. Dexamethasone 10mg given intramuscularly in ER.
28 2021-01-21 lacrimation increased 12/23/20 1ST DOSE (AFTERNOON/EVENING): CHILLS, BODY ACHES, TEARING/CRYING. BACK PAIN 1/12/21 2ND DOS... Read more
12/23/20 1ST DOSE (AFTERNOON/EVENING): CHILLS, BODY ACHES, TEARING/CRYING. BACK PAIN 1/12/21 2ND DOSE (AFTERNOON/EVENING): WORDS/CHALLENGES COMMUNICATING FOR 24 HRS
28 2021-01-21 sensitivity to light Body Aches, Chills, Sweats, Migraine, light sensitivity
28 2021-01-24 loss of smell can't even think; no sense of smell; sick; headache; flu type symptoms with sinus pressure; flu type... Read more
can't even think; no sense of smell; sick; headache; flu type symptoms with sinus pressure; flu type symptoms with sinus pressure; sore throat; brain fog; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 28-year-old female patient received BNT162b2 (lot number: EL3246), via an unspecified route of administration in left arm on 09Jan2021 at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient got the COVID 19 vaccine on 09Jan2021, and symptoms started shortly right after, with headache, flu type symptoms with sinus pressure, all on 09Jan2021; and this morning (13Jan2021) she woke up with no sense of smell. She is so sick right now (13Jan2021), said she can't even think right now (13Jan2021). The patient stated the only thing that improved was the headache went away, and in the first two days (Jan2021), she had a sore throat, and that has gone away, but everything else has stayed constant. The patient had brain fog in Jan2021. The patient underwent lab tests and procedures which included weight: 125 pound range. The outcome of the event headache was recovered on 09Jan2021, the sore throat was recovered in Jan2021, other events was not recovered.
28 2021-01-24 eye pain weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more ... Read more
weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more than a normal vaccine; She had a fever then; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) at single dose at left deltoid for COVID-19 immunisation on 11Jan2021 at 4:30 pm. Relevant history included contraception. Family Medical History Relevant to AE(s) was none. Concomitant drug included ongoing ethinylestradiol, etonogestrel (NUVARING) for contraception for years. The patient experienced a headache, back ache, nausea and was almost passing out. She had the first dose of the vaccine on the 11Jan2021 at 4:30 PM and was in bed around 10:00 that night. She woke up at 5:00 AM on 12Jan2021 and didn't feel great, her arm was killing her more than a normal vaccine and she was nauseated at 5:30, which was not that horrible. She took some Tylenol. Then she got to work and around 9:00 she felt like she was going to get sick. She had horrendous nausea, chills, weakness, eye pain, headache/ head pain, and back pain. Her clothes hurt because the body aches were so bad. She felt like she was going to pass out, like a vasovagal. She went to urgent care because her manager didn't think it was side effect. She went and got swabbed (result unknown), whatever. She had a fever then. They told her it was a reaction to the vaccine. Her temperature was 101.6 degrees Fahrenheit when she went to Urgent care. She would say the fever started at 12:30PM on 12Jan2021. She did not know if fever would be ongoing because she was taking fever reducer and it was working. The events weakness, eye pain, head pain, and back pain were reported as serious since medically significant. The nausea was better around 2:00PM. The outcome of event nausea, Chills was and Weakness was resolved on 12Jan2021. The outcome of events eye pain, head pain, and back pain was resolving. The outcome of event 'her arm was killing her more than a normal vaccine' was recovering. The outcome of fever was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, weakness, eye pain, head pain, and back pain, and the administration the suspect vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
28 2021-01-24 swollen tongue Reporter received the second COVID-19 vaccine on 1/20/2021 at 08:25 AM. She had proactively taken d... Read more
Reporter received the second COVID-19 vaccine on 1/20/2021 at 08:25 AM. She had proactively taken diphenhydramine following the reaction to her first dose. Around 08:40 AM, she began to feel tightening in her throat and some heaviness in her chest. She was evaluated by a nurse who took her blood pressure (normal), however, her heart rate was elevated (noted this could be that she was nervous following initial reaction and repeat tightness in throat). Around 08:55AM, she began to feel like her tongue was swelling and that she had a "bubble" on the top of her throat. She was taken to the Emergency Department for evaluation. She was given hydroxyzine, famotidine, and dexamethasone in the ED and was discharged and felt stable. She reported a continued odd sensation in her throat the evening of the second vaccination. This feeling resolved the next day, and she reports no additional side effects from the vaccine. Of note, patient had experienced a similar reaction following her first vaccination (E-number 261589)
28 2021-01-25 lip swelling, mouth numbness arm soreness for 2 days after injection, lips swelling and numbness for couples hours on the second ... Read more
arm soreness for 2 days after injection, lips swelling and numbness for couples hours on the second day after injection, consistent headache on second day, significantly decrease in breastmilk supply starting 2-3 days after injection and hasn't recovered (I'm breastfeeding my baby completely since birth in July 2020).
28 2021-01-27 taste impairment Ten minutes after receiving vaccine, I started experiencing a strong metallic taste in my mouth. I w... Read more
Ten minutes after receiving vaccine, I started experiencing a strong metallic taste in my mouth. I was told I was only the second person the vaccine administrator heard of having that symptom. No other symptoms.
28 2021-01-27 eye bleeding She immediately started having hot flashes after receiving vaccination, that have not resolved since... Read more
She immediately started having hot flashes after receiving vaccination, that have not resolved since time of patient reporting ADR on 1/14/21 (~12 days in duration). She also experienced a bad headache with blood vessel rupturing in her eyes.
28 2021-01-27 lip swelling Unilateral facial and upper lip swelling on left side of the face started approximately 24 hours aft... Read more
Unilateral facial and upper lip swelling on left side of the face started approximately 24 hours after vaccine dose 2. Benadryl 50mg taken before bed and swelling remained in the morning of 1/28. Benadryl 50mg and 20mg Pepcid taken the morning of 1/28 and ice applied to the area of swelling. No facial dropping (smile is symmetrical), no swelling of tongue/throat, no difficulty breathing.
28 2021-01-27 swollen tongue patient experienced swollen tongue and throat. Also onset headache. Given DiphenHydramine with good ... Read more
patient experienced swollen tongue and throat. Also onset headache. Given DiphenHydramine with good effect. No breathing difficulty.
28 2021-01-29 eye pain Nausea, headache, joint pain, back and neck pain, pain at injection site, chills, hot flashes, eye p... Read more
Nausea, headache, joint pain, back and neck pain, pain at injection site, chills, hot flashes, eye pain when looking at light
28 2021-01-30 mouth numbness Pfizer COVID-19 Vaccine EUA Event Description: Felt light headed and slight numbness in tongue and t... Read more
Pfizer COVID-19 Vaccine EUA Event Description: Felt light headed and slight numbness in tongue and throat about 10 minutes post Covid-19 vaccine (Pfizer EL9261, exp. 5/1/21). History of vasovagal reactions. Also said numb tongue made her think of trouble swallowing. Given water, Benadryl 25mg PO, Zyrtec 10mg PO, and Famotadine 20mg PO and felt better. Heart: RRR without mrg Lungs: clear Skin: blotchy and slightly flushed in spots Throat clear No problems swallowing medications, also given Ginger Ale
28 2021-01-31 ear pain On 12/30 I developed neck pain, a headache, chill and shaking but no fever, diarrhea, ear pain and n... Read more
On 12/30 I developed neck pain, a headache, chill and shaking but no fever, diarrhea, ear pain and nasal congestion. I had a virtual visit with the NP and was advised if the symptoms got worse to take tylenol and ibprophen. I was advised I could take mucinex and recommended a COVID test. It was performed on 12/31 which was negative so I took mucinex for the congestion and after 2 or 3 days I began to feel better.
28 2021-02-01 ear swelling elevated redness sort of like a rash around the injected area; rash came back in the injected area; ... Read more
elevated redness sort of like a rash around the injected area; rash came back in the injected area; it was itchy; my face was swollen and ears; my face was swollen and ears; hives on my face; skin was very dry; rash like; This is a spontaneous report from a contactable healthcare professional reporting for a patient. A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 31Dec2020 at 14:00 (at the age of 28-years-old) as a single dose for Covid-19 immunization. Medical history included tuberculosis (TB) when younger and took medication for it from an unknown date. The patient was allergic to penicillin and breaks out in hives and a rash. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included spironolactone (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date after the vaccination, the patient experienced elevated redness sort of like a rash around the injected area for 2 days and then it went away, exactly a week later the rash came back in the injected area but did not spread and lasted another two days. On 14Jan2021 at 04:00 the patient experienced broke up in hives on face, face was swollen, and ears and it was itchy. The patient experienced skin was very dry and rash like but not itchy on an unknown date in Jan2021. Therapeutic measures were taken for the swelling face, ear swelling, hives and pruritis which included Benadryl for 2 days which helped the events go down. The clinical outcome of the event injection site erythema, swelling face, ear swelling, hives and pruritus was recovered; injection site rash, dry skin and rash were unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-02-01 drooping eyelid Bell's Palsy. Symptoms include right sided facial weakness, eye drooping. Onset was around 12:30 on ... Read more
Bell's Palsy. Symptoms include right sided facial weakness, eye drooping. Onset was around 12:30 on 1/28. Went to walk in clinic where MD confirmed Bell's Palsy and prescribed Valacyclovir and Prednisone. Started medications around 5pm on 1/28.
28 2021-02-02 mouth numbness, mouth tingling 28 yo F here at 30mdg for covid vaccine. pt with h/o "anaphylaxis with other shots." Pt notes had f... Read more
28 yo F here at 30mdg for covid vaccine. pt with h/o "anaphylaxis with other shots." Pt notes had facial/nose/lip tingling with prior vaccines, requiring steroids and oral Benadryl. Patient received the covid vaccine at approx 1715 on 21 Jan 2021. At approx 15 minutes, pt developed numbness and tingling to her nose and lips. pt notified Rapid Response Team, who notified Physician. monitored patient for 5-7 min, pt noted that her symptoms were worsening, to include numbness and tingling affecting most of her face, cheeks, lips and nose. No trouble breathing. no lip swelling or tongue swelling. HR 78. Gave oral benadryl - gave her 4 ml of po benadryl (12.5 mg/5ml) at approx 1735, and another 4 ml po benadryl (12.5 mg/5ml) at approx 1740. pt prefers to be treated with steroids because a similar previous episode resolved with benadryl and steroids. pt symptoms persisted with facial numbness and tingling ... and subjectively were worsening. no coughing, no tongue swelling. no lip swelling. no shortness of breath. FM physician arrived - prepped for 60 mg im solumedrol. at approx 1750, FM physician gave IM Solu-Medrol in R shoulder. pt waited for approx 15 min - felt better. numbness and tingling of face and nose were lessening, almost gone - only tip of nose was affected. no facial swelling. no lip or tongue swelling. no trouble breathing. no shortness of breath. physician gave return parameters - benadryl prn overnight called patient the following monday - stated she slept that night (from benadryl), felt better the next day. no further concerns
28 2021-02-03 photosensitivity reaction body aches; chills; sweats; migraine; light sensitivity; This is a spontaneous report from a contact... Read more
body aches; chills; sweats; migraine; light sensitivity; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular on left arm on 20Jan2021 at 13:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not allergic to medications, foods, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and multivitamin. The patient was not pregnant at the time of vaccination. The vaccine was administered at the patient's workplace clinic. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced body aches, chills, sweats, migraine, and light sensitivity, all on 21Jan2021 at 09:00. She did not receive any treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Jan2021. No follow-up attempts are possible. No further information is expected.
28 2021-02-05 lip swelling On January 29 my lip randomly started swelling. I was laying in bed no food or drink for over an hou... Read more
On January 29 my lip randomly started swelling. I was laying in bed no food or drink for over an hour. No medications, new body washes soups etc. no new laundry detergent. Thought it was random until my lip once again started swelling on 2/1 in the morning while brushing my teeth (nothing new about routine) it then once again started to swell at work on 2/4 once again no food or drink or change in anything, and lastly began again last night 2/5 while laying in bed. Each time has been different locations of the lips has not spread further and has be variant in symptom intensity. One case only lasting minutes and 2 lasting up to 24 hours. Might not be related to vaccine but I?ve never had any allergies before and this began after, so for the sake of research decided to report.
28 2021-02-07 extreme sound sensitivity, sensitivity to light Fatigue and mild headache starting 24 hours after the injection. Approximately 30 hours after inject... Read more
Fatigue and mild headache starting 24 hours after the injection. Approximately 30 hours after injection, headache progressed to severe headache with migraine features (sensitivity to sound and light) Symptoms resolved within 48 hours.
28 2021-02-07 mouth discomfort, mouth tingling Itchy throat; left side of face burning; left side of face burning/tingling sensation; burning/tingl... Read more
Itchy throat; left side of face burning; left side of face burning/tingling sensation; burning/tingling sensation left side of lip; burning/tingling sensation and left side of lip; This is a spontaneous report from a contactable other healthcare professional. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration second dose (lot number: EL3302) on 21Jan2021 17:00 at single dose on right arm for COVID-19 immunization. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: E11284, on 29Dec2020 13:30 on right arm. Medical history included asthma and seasonal allergies. The patient did not test for COVID post vaccination. The patient is not pregnant. The patient experienced itchy throat, left side of face burning/tingling sensation and left side of lip on 21Jan2021 17:45. The patient took Benadryl as treatment for the events. The outcome of the events was recovering.
28 2021-02-07 tongue itchiness, mouth itchiness, swollen tongue Itching in tongue/mouth/throat, hot flashes, dizziness, sweating, tongue swelling, tachycardia
28 2021-02-12 swollen tongue 10 minutes After injection, tongue and throat began to swell, breathing became labored, and skin on ... Read more
10 minutes After injection, tongue and throat began to swell, breathing became labored, and skin on neck was itchy and red. Liquid Diphenhydramine was attempted, however was unable to be administered without slight aspiration, so injection of Epinephrine was administered. Within 5 minutes, airways returned to normal, SPO2 on room air was 98%, and was cleared to go home.
28 2021-02-12 vision blurred With 15 minutes of first dose patient experienced dizziness, blurred vision, face swelling and extre... Read more
With 15 minutes of first dose patient experienced dizziness, blurred vision, face swelling and extreme fatigue. These symptoms subsided and the patient slept. The following day patient woke up with a 8 pain scale neck pain, stiffness and some head pain in the back of the skull, and arm soreness. Patient focused on hydration and rest. Today (02/12/2021) neck pain and stiffness has persisted, with slight headache on the back of the head. Reduced to a 4 pain scale. Overtime patient has also consistently experienced low-appetite, and fatigue. Patient is looking to understand why these symptoms have persisted, and how it can be resolved.
28 2021-02-14 eye discomfort Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pal... Read more
Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-02-14 pain in jaw Initial side effects were minimal/expected. After about 48 hours I started experiencing jaw pain in ... Read more
Initial side effects were minimal/expected. After about 48 hours I started experiencing jaw pain in the left mandible extending up to the left temporomandibular joint. I have a relatively high pain tolerance so I wouldn't say the pain was severe or life-altering, but since the frameworks reported occurrences of reactogenicity at 3 or greater and I am taking OTC pain medication to manage my jaw pain, I figured it was a data point worth reporting. The pain is certainly tolerable, but makes opening my jaw fully or chewing on the left side unpleasant enough to make it worth taking painkillers.
28 2021-02-15 blindness Blindness (loss of vision); Neurocardiogenic syncope; Tingling in hands and feet/lower legs; Panic a... Read more
Blindness (loss of vision); Neurocardiogenic syncope; Tingling in hands and feet/lower legs; Panic attack/unable to breathe; Nausea; Vomiting; Dehydration; Tiredness; Body aches
28 2021-02-15 ear discomfort Both ears feel full 5 mins after sitting in monitoring area. EMS Evaluated. Stayed extra 10 minute... Read more
Both ears feel full 5 mins after sitting in monitoring area. EMS Evaluated. Stayed extra 10 minutes then felt better.
28 2021-02-15 mouth tingling L arm, some numbness and tingling, "tongue feeling fat", toes tingling". Patient was taken to triage... Read more
L arm, some numbness and tingling, "tongue feeling fat", toes tingling". Patient was taken to triage, tongue and oral membranes assessed, no signs of swelling, lungs clear, v.s. taken, patient given 25mg of benedryl IM., patient also given orange juice, continued to monitor for 30 minutes, symptoms subsided. Patient was walked out and driven home by her co-worker.
28 2021-02-15 mouth tingling lip tingling, throat tightness, dyspnea, facial hives
28 2021-02-22 eye pain Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection s... Read more
Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection site, headache, fatigue
28 2021-02-22 oral mucosal blistering Cold sore/fever blister outbreak. I haven?t had a cold sore in 3 years and can recognize when one is... Read more
Cold sore/fever blister outbreak. I haven?t had a cold sore in 3 years and can recognize when one is forming. The following evening after receiving the shot I felt a cold sore begin, now have multiple blisters around my mouth. Has never this severe.
28 2021-02-23 loss of smell, loss of taste Painful arm (could not lift arm) for 2 days Cough Fever Body aches/chills Loss of smell/taste Diz... Read more
Painful arm (could not lift arm) for 2 days Cough Fever Body aches/chills Loss of smell/taste Dizziness Headache Extreme fatigue Neck pain These symptoms lasted approximately 9 days
28 2021-02-23 ear pain Pain began as a "crick" in the left side of the neck two days after receipt of second covid vaccine.... Read more
Pain began as a "crick" in the left side of the neck two days after receipt of second covid vaccine. It has now been three weeks and pain has been continuous in the left shoulder and left neck. Pain radiates down the arm and up into the ear, making the ear hurt and making it painful to swallow. The skin is also tender/painful to touch in the same areas, as if nerve damage has occurred. Swelling is visible in the upper back and neck.
28 2021-02-23 mouth numbness, swollen tongue Left arm with fingers tingling, tongue feeling "fat" and numb, toes tingling, Benadryl administered,... Read more
Left arm with fingers tingling, tongue feeling "fat" and numb, toes tingling, Benadryl administered, No EMS, resolved during extended observation.
28 2021-02-24 eye movement disorder Ballspalsy, right side Eye and facial movement issues, it started gradually a week and a half after ... Read more
Ballspalsy, right side Eye and facial movement issues, it started gradually a week and a half after my dose my eye was not blinking in sync with my left eye, gradually started to go down to my face where my lips my cheek or my eyebrows were not moving when I was talking all my words were slurred and off to the side of my mouth. When smiling one side trip the far far left the other side stay still. My job had me go to a doctors up where they diagnosed me with Bell?s palsy it and the doctor advised me to report this. My treatment plan is antiviral medication and steroids, Valacyclovir 1gm tid, methylprednisolone 4grams qid. I am very upset and heartbroken every time I look in the mirror I cry because I cannot recognize my face I did read online that Pfizer did have side effects of bells palsy but I never thought I would get it given my age and good medical history. I would love for someone to reach out to me I need to know what happens from here. As a result I have been off of work for a couple days.
28 2021-02-24 mouth numbness Numbness on lips, tingling.
28 2021-02-25 mouth numbness, tongue discomfort, swollen tongue, feeling of choking, mouth tingling 3-5 minutes after receiving the vaccine, I felt a sense of panic and a tingling on my lips, that the... Read more
3-5 minutes after receiving the vaccine, I felt a sense of panic and a tingling on my lips, that then spread to my mouth, throat, and tongue. I asked the nurse if my lips were swollen, and she said no. A few minutes later my heart rate increased and I felt really lightheaded. After 7-10 minutes I felt my tongue tingling and it had become swollen. I told the nurse that I think my tongue was swollen and she said it looked okay. I had a hard time talking because I wasn't used to be tongue being so large. The nurses stayed and talked to me for the rest of the 30 minute waiting period. I was able to talk and breath while making a conscious effort. I wasn't sure whether the high heart rate and lightheadedness were associated with my condition, Postural Orthostatic Tachycardia Syndrome. I kept checking my tongue to see how swollen it was. After the 30 minutes, the nurses had me stand up to see if I could. Once I could, they said I was all set to go. They did not get an Epi-pen for the swollen tongue or give me instructions on how to treat it. They were insensitive and dismissive of my symptoms. they kept repeating "I think your just nervous." Once I got home, I still had the swollen tongue and tingling, but was able to go up and down stairs and go about my day. It was a little difficult to swallow one of my pills when I got home, but I was able to. I checked my blood pressure around 4:30 p.m. and it was 121/84 and my pulse was 79 bpm sitting. I did not take anything to treat my swollen tongue. The swollen tongue and tingling feeling in my throat continued for another 2.5 hours, until 6:00 p.m. Once the swelling was down, my tongue felt like I burnt it on a hot beverage, almost a numb feeling. I also experienced more common side effects such as body aches, fatigue, and feeling feverish. After this episode I had extremely high anxiety where it was difficult for me to sleep the following night. I called a 24/7 nurse line and she said to talk to my doctor. I had less than 4 hours sleep the night after I had my vaccine. I called my doctor's office this morning and I spoke to a nurse who worked as a nurse on the COVID Vaccine hotline. She relayed the message to the doctor who was covering for my doctor while she's on medical leave. I received a call around 9:30 a.m. saying that the doctor on leave recommend I should talk to my PCP but that she thought I had an allergic reaction to the Pfizer vaccine and that I should not get the second dose. She said they were not sure how I would react with the second dose, and they're afraid that my allergic response might be more severe and life threatening. I hope this report helps other people who experience these symptoms.
28 2021-03-01 ear pain 28-year-old female, medical assistant employee presents to urgent care 45 minutes after receiving he... Read more
28-year-old female, medical assistant employee presents to urgent care 45 minutes after receiving her second dose of covered vaccine, presents to urgent care complaining of a 4 of 10 throbbing headache and left ear/lateral neck pain. She has not taken anything for pain, having come straight from work/vaccination clinic. She tolerated her first dose of vaccine well.
28 2021-03-06 dry mouth Sweating, chills, extreme fatigue, dry mouth, dizzy, headache
28 2021-03-07 lip swelling Swelling to the upper lip; This is a spontaneous report from a contactable nurse. A 28-year-old fema... Read more
Swelling to the upper lip; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received BNT162B2 (Pfizer COVID 19 vaccine), lot no. EL0142 with expiry date Mar2021, via an unspecified route of administration (left arm) on 03Feb2021 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient got the COVID vaccine today (03Feb2021). She had an adverse reaction. She didn't have it within 15 minutes. She had it several couple of hours later. She had swelling to the upper lip on 03Feb2021. She took a Tylenol and Benadryl. The outcome of the event was unknown.
28 2021-03-07 sensitivity to light 18-40 hours after getting vaccine: sensitivity to light headache with light activity (walking more t... Read more
18-40 hours after getting vaccine: sensitivity to light headache with light activity (walking more than 5 minutes) fatigue muscle/joint pain injection site swelling and redness soreness at injection site (lasting 48 hours +)
28 2021-03-10 mouth tingling, feeling of choking, mouth discomfort, mouth numbness, taste impairment Metallic taste in mouth, then following with numbness, tightening, and tingling in throat and mouth.... Read more
Metallic taste in mouth, then following with numbness, tightening, and tingling in throat and mouth. First treated with Benadryl, then decadron and Pepcid. After reaction did not stop, I was taken to the ER and given IV steroid(s). On discharge I was given epinephrine and prednisone. This occurred over a four hour period.
28 2021-03-10 light flashes or floaters in the eye Difficulty breathing, eyes fluttering, crying approximately 15 minutes after administration
28 2021-03-13 thirst Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unkn... Read more
Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unknown number), Nausea, Dizziness, Unable to stabilize quickly, not able to get an IV, extreme thirst Signs: Immediately felt unwell within 5 minutes of the vaccine. Time Course: Injection (1st dose - Pfizer) at 4:00pm. Adverse Reaction at 4:05/4:10 (est.) Released at 5:00pm (est.) Description of Incident: On March 8th, at 4:00 pm, I received my first dose of the covid vaccine. Within 5 to 7 minutes, I felt unwell while sitting in the waiting area. I walked towards a worker to inform them that I was feeling unwell and that I was going to pass out. I became unresponsive and laid on the ground. My husband was with me at the time. I was unconscious for a bit and when I regained consciousness, my legs were being raised. I regained consciousness and was able to recall my name, DOB, and address. After I was done recalling my information, I began to lose consciousness again. They brought a wheelchair and took me to the medical room. As I moved from the wheelchair to the bed, I began to lose consciousness again. They told me to lay down. I overheard a woman ask my husband if I had diabetes or heart problems. He answered ?No.?. She explained to him that my body did not know how to accept the vaccine and was trying to regulate back to normal. She explained that my body was going through ?homeostasis? (?). While I laid on the bed, some workers took my blood pressure and tried to start an IV. One of them made a comment and said I was extremely dehydrated. This was odd to hear because I normally drink 3 to 4 liters of water daily. During this entire medical event, I felt the water pushing out through my pores. I was drenched in sweat. He tried to start an IV on my left arm and was unsuccessful. He tried to start an IV on my right hand, which was also unsuccessful. He stated they were unable to start IV liquids because my veins kept popping/collapsing. My blood pressure was reading 60. They checked it again, still at 60. I laid in the bed and basically waited it out. After a few minutes, they checked my blood pressure at it was at 120. They said that was good and I was good to go. No report was given to me nor my husband about the event that occurred. Even after they agreed to let me use a wheelchair (due to feeling weak), one was not provided to me. They basically stated that I was ?good to go?, after doing a series of hand squeezes and walking a few steps upright. I am currently trying to obtain a copy of the report I saw the gentleman fill out at the time. I was given Zofran to help with my nausea, it was placed under my tongue. After going home, I felt weak, tired and somewhat lightheaded. My husband drove me home and I got some rest. I set an appointment with my doctor on Friday March 12th to determine what happened to me during my vaccine and to record the incident. After describing the incident, she determined that it was anaphylaxis. She recommended for me not to get my second dose due to the anaphylactic shock I experienced with the first dose. She was shocked to learn that they did not transport me to the hospital or provided an Epi Pen injection. When asked why I didn?t drive myself to the hospital, I let her know that they told me I was ?good?. They did not explain what had occurred to me, no mention of anaphylaxis was explained. I was not aware that is what had occurred. The incident occurred from 4:00pm (injection time) to 5:00pm (left location).
28 2021-03-14 mouth tingling, tongue discomfort, swollen tongue, feeling of choking, mouth numbness I had an allergic reaction; I experienced a tingling feeling in my lips, which then spread to my mou... Read more
I had an allergic reaction; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; lightheaded; elevated heart rate; tongue was swollen; my tongue felt like it was numb/burnt by drinking a hot liquid; my tongue felt like it was numb/burnt by drinking a hot liquid; woke up in the middle of the night; trouble sleeping; This is a spontaneous report from contactable consumers (one is the patient). A 28-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6203), via an unspecified route of administration in the left arm on 25Feb2021 15:30 at a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, migraines, asthma, hay fever, acid reflux, hives when exercising outdoors in the cold, and allergies: latex, cats, dustmites, gluten and dairy intolerance; all from unknown dates. Concomitant medications included sumatriptan, bupropion, pepsin, calcium carbonate and unspecified herbs. The patient did not received other vaccine in four weeks. The patient previously took fluconazole (DIFLUCAN) and experienced allergies. A few minutes after taking the vaccine, the patient experienced a tingling feeling in lips, which then spread to mouth, throat and tongue. The patient told a nurse and she said that she looked fine. The patient asked if lips were swollen but they weren't. Then a few minutes later she felt very lightheaded and had an elevated heart rate. Then around this time, she saw her tongue was swollen to about double the size. The nurse said she looked fine, and monitored her for 30 minutes then let her go. This swollen tongue lasted for about 2.5 - 3 hours. After the swelling subsided, tongue felt like it was numb/burnt by drinking a hot liquid. 12 hours later, she woke up in the middle of the night with an elevated heart rate and had trouble sleeping. The patient spoke to her doctor and it sounds like she had an allergic reaction, even though she have no history of allergies for any of the vaccine ingredients. Onset date of all events were reported as 25Feb2021 15:30. Outcome of all events reported as recovered on an unspecified date. No treatment was given for all events. The patient was not diagnosed of covid prior vaccination and has not tested for covid post vaccination.
28 2021-03-14 ringing in ears Dizziness, ringing in ears, stated felt like passing out and fainted many times before with flu vacc... Read more
Dizziness, ringing in ears, stated felt like passing out and fainted many times before with flu vaccine and blood drawing 63/45 12:25 81/57, 57, 16, 90/62 100% room air
28 2021-03-14 vision blurred Blurred vision, numbness on left side of body, restlessness
28 2021-03-15 mouth numbness, mouth tingling Numbness tingling around mouth, throat, chest tightness. 143/99-78; resolved
28 2021-03-16 mouth tingling, lip swelling, lip blister Lung pain; splitting headache; could not sleep; feels run down; developed bubbles filled with fluid ... Read more
Lung pain; splitting headache; could not sleep; feels run down; developed bubbles filled with fluid all over her lips; feels bad; achy; arm hurt; swelling and tingling sensation around my lip; swelling and tingling sensation around my lip; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 09Feb2021 at (at the age of 28-years-old) as a single dose in the deltoid (unspecified) for COVID-19 vaccination. Medical history included asthma, Meniere's disease, cold sores and she had COVID-19 with symptoms of splitting headache, all on an unknown date. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA) for asthma from an unknown date and ongoing and supplements (unspecified) for Meniere's disease. The patient previously received the first dose of BNT162B2 on 15Jan2021 and experienced achy, arm hurts, weird lung pain and splitting headache. Within minutes of receiving the second dose on 09Feb2021 the patient experienced swelling and tingling sensation around the lip and arm hurt. On 10Feb2021 the patient experienced bubbles filled with fluid over her lips in the morning, she felt bad and is achy; from an unknown date the patient experienced feels run down, weird lung pain, a splitting headache and she could not sleep. Therapeutic measures were taken as a result of the headache which included Aleve and she drank a bunch of water with her daily vitamins. The clinical outcome of the events lip swelling, tingling lips, lung pain, insomnia, fatigue was unknown; lip blister, feels bad, achy and arm hurt was not recovered; and headache was recovered The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
28 2021-03-17 mouth tingling, feeling of choking 1450- pt requested assistance for tachycardia, tingling lips and dizziness. Requesting benadryl, 50m... Read more
1450- pt requested assistance for tachycardia, tingling lips and dizziness. Requesting benadryl, 50mg given PO. VS 128/54, P90, 20R, 98% sat. 1500- increased dizziness, throat tingling. VS 130/89, 104P, 24R, 98% 1508- increased throat tingling, "hard to breath" declines epi or EMS to be called. 1511- self-administered epi pen, EMS notified. 1516- remains light-headed/dizzy, resp adequate at 22/min, O2 sat 98% 1524- speaking clearly, remains fully conscious. Resp regular. Lungs CTA, MM pink. VS 130/70, 83P, 20 R, 98%sat 1530- Await EMS arrival. Pt able to easily talk on phone with family member. Still c/o itchy throat and lips. 1535- EMS here, pt escorted out building with EMS at 1537.
28 2021-03-18 hearing loss, ringing in ears, loss of taste Tinnitus in my right ear started wednesday morning 3/17/2021 later that day around 10am I went to ea... Read more
Tinnitus in my right ear started wednesday morning 3/17/2021 later that day around 10am I went to eat my breakfast and could not taste anything. immediately went to get covid tested at the health department. rapid test was negative. both side effects are still ongoing friday 3/19 as i am reporting this information. taste may be coming back slightly but my ear still suffers from tinnitus, sounds are robotic and vibrating.
28 2021-03-21 eye strain At 4:15 pm, While under observation for 30 minutes, pt c/o heaviness in the eyes., and slight chest... Read more
At 4:15 pm, While under observation for 30 minutes, pt c/o heaviness in the eyes., and slight chest pain. pt. also c/o nausea and vomiting symptoms. pt. c/o numbness in the left arm. Pt. was encouraged to take deep breaths. Pt. was helped to the ground in a supine position. BP=140/90, HR=88, RR=18 . Pt was alert and oriented X4. 2 minutes after deep breaths, patient reported that all symptoms had subsided except numbness in the left arm.
28 2021-03-22 canker sore Allergic reaction in mouth, severe canker sores on tongue and roof of mouth developed a few days aft... Read more
Allergic reaction in mouth, severe canker sores on tongue and roof of mouth developed a few days after the first shot and continued after the second shot, getting worse
28 2021-03-23 dry throat Pt here receiving first dose of Pfizer covid vaccine. Pt requested that someone sit with her due to ... Read more
Pt here receiving first dose of Pfizer covid vaccine. Pt requested that someone sit with her due to her being extremely nervous and having previous anaphylactic reactions in the past. The patient and I began to talk about our children, jobs and hobbies when she started to complain that her throat was really dry and raspy. The patient was given water and her vitals were taken. Pt is tachycardic. Vitals are160/100. , HR is 125 RR are 22 02 is 100. Pt is alert and oriented and states she is ok and would like me to update her husband and sister. Pt offered further medical attention and accepted. 911 called at 12:32 by Rn site lead. Benadryl administered to left deltoid at 12:29 By Rn . 911 operator advised RN to administer epi. Epi administered by RN at 12:32. Pt is alert oriented x3 . Ambulance arrived at 12:45 to transport pt to local hospital for further evaluation, Husband and sister notified. Pt Left this facility at 12:55. Pt Vaccinated on 3/24/2021 11:55 Right deltoid Pfizer 1st dose Adverse event began at 12:10 transferred care 12:45
28 2021-03-24 lip swelling About 30 minutes after receipt of the first dose of the Pfizer COVID vaccine, my upper lip was sligh... Read more
About 30 minutes after receipt of the first dose of the Pfizer COVID vaccine, my upper lip was slightly swollen on the same side as where I received the vaccine (left), and I had redness in my face for about 1.5 to 2 hours. I also had a slight lump in my throat 15-30 minutes after receipt. I never felt like I was in danger or needed immediate medical attention, and the symptoms subsided without medication.
28 2021-03-24 ringing in ears Ringing in left ear
28 2021-03-25 mouth tingling, mouth numbness 28 yo female received second dose of Pfizer COVID-19 vaccine 3/19 at 0933. Around 1130 pt reports nu... Read more
28 yo female received second dose of Pfizer COVID-19 vaccine 3/19 at 0933. Around 1130 pt reports numbness and tingling in her mouth and right sided facial drooping. Presents to ED. History of right frontal cavernous malformation, removed in 2013. PMH significant for migraine headaches and vestibular disorder. Evaluated by neurovascular with low suspicion for stroke. Symptoms improving. Received diphenhydramine, ketorolac and prochlorperazine in the CDU. CT brain and angio brain and neck without acute findings. Recommended pt to complete brain MRI with and without contrast to rule out possibility of stroke or underlying lesions to be performed outpatient. Pt discharged later that day with symptoms fully resolved.
28 2021-03-26 lip pain Chest pain with changes in ECG, Sensation "rubbery lips",
28 2021-03-29 inability to speak Redness, heat, and tenderneas at injection site for 6 days, loss of voice, head ache, fatigue
28 2021-03-30 lip swelling itching on arms, feet, ankle, heartburn: rash spread, upper lip swelling, throat itchy, tonguevswell... Read more
itching on arms, feet, ankle, heartburn: rash spread, upper lip swelling, throat itchy, tonguevswelling, body aches
28 2021-03-31 extreme sound sensitivity, sensitivity to light Headache and nausea that persisted 3 weeks after vaccine was administered. I usually don?t get heada... Read more
Headache and nausea that persisted 3 weeks after vaccine was administered. I usually don?t get headaches at all and they became constant. I was sensitive to light and sound for a few days at the onset of symptoms. I took Tylenol a couple of times when headache was at its worse. After 3 weeks symptoms diminished.
28 2021-03-31 smell distorsion Started experiencing parosmia a few days after the vaccine. Everything smelled like spoiled milk; pe... Read more
Started experiencing parosmia a few days after the vaccine. Everything smelled like spoiled milk; people around confirmed that nothing smelled like that. The smells have changed (it smelled like spoiled fruit and formaldehyde for about a day, and it now smells like durian), but I have been nonstop smelling disgusting phantom smells for days now, causing me to lose my appetite.
28 2021-04-01 ear discomfort I received the second dose of the Pfizer vaccine on Friday, March 5th at around 10:00AM. On Saturday... Read more
I received the second dose of the Pfizer vaccine on Friday, March 5th at around 10:00AM. On Saturday March 6th around 9:00PM, I started experiencing a tingling sensation in my eyelid that spread to the left side of my head, arm, fingers, and toes. The tingling sensation spread to the right side of my body by the following Friday, one week after the shot. I had high blood pressure, rapid heart rate, head and ear pressure. It is now April 2nd, four week after the second Pfizer dose, and the tingling sensation continues to come and go. I have had a left side headache off and on most days since the second dose.
28 2021-04-01 bloodshot eyes, blindness, eye itchiness, eye pain Flu like symptoms 4 days. Those disappeared. On day 2 after injection my elect eye became itchy, ver... Read more
Flu like symptoms 4 days. Those disappeared. On day 2 after injection my elect eye became itchy, very painful, and red. It never got better. Then on day 12 I lost vision in that eye. Still painful. I continue to have half tunnel vision and pain.
28 2021-04-01 ringing in ears Arm pain after shot, no other symptoms until going to sleep. Woke up with headache around 1:45am Tri... Read more
Arm pain after shot, no other symptoms until going to sleep. Woke up with headache around 1:45am Tried to get water at 2:20am to help headache Got nauseous next to sink - feeling like throwing up while pouring water Passed out Woke up shortly after on kitchen floor Stumbled to bedroom on super weak legs (which were kinda giving in) When laying back down ringing (like static) in ear for about 1min and tingly feet and hands for about 3min Afterwards still feeling weak and having headache but no other symptoms. Awake with headache until 6am, slept 6am-7am, woke up with slight feaver, headache persisted 8:30am took daily meds, had food and water, took sumatriptan for headaches and awake until 11:30am Slept from 11:30am to 1:30pm - woke up feeling A LOT better, little to no headache left, only still feeling weak and armpain
28 2021-04-02 ringing in ears Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotensi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium
28 2021-04-03 mouth tingling, mouth numbness, mouth itchiness, swollen tongue I was vaccinated with the 2nd dose of the vaccine at 3:25 pm on 4/3/2021. Later that day, maybe arou... Read more
I was vaccinated with the 2nd dose of the vaccine at 3:25 pm on 4/3/2021. Later that day, maybe around 5pm, my lips and the inside of my mouth started to feel itchy with a very slight tingling sensation. This went away after about 3 minutes. When going to bed around 11:30pm, my mouth again felt itchy. I went to sleep and woke up at 3:10 am and the tip of my tongue felt numb with a fizzing sensation. It was more intense than what was previously felt before. The end of my tongue had both numbness and tingling. This subsided and went away after about 10 minutes. When I woke up in the morning the next day around 8am, I still had lingering feels of tongue tingling that have come and gone intermittently throughout the morning. My tongue also appears different than usual with it being slightly larger in size and with new ridges/grooves along the side of the tongue, bilaterally. Also noted was the slightest tongue deviation to the left along with subtle right sided facial droop, hardly perceptible. Body aches and general malaise also present.
28 2021-04-04 loss of taste, loss of smell Diagnosed with COVID 19 on 4/4/21. She developed sinus congestion on 3/31 and loss of taste and smel... Read more
Diagnosed with COVID 19 on 4/4/21. She developed sinus congestion on 3/31 and loss of taste and smell on 4/2.
28 2021-04-04 sensitivity to light, eye pain Headache initiated on day of injection remained dull for 36 hours then exacerbated to migraine type... Read more
Headache initiated on day of injection remained dull for 36 hours then exacerbated to migraine type headache with photophobia, Left occular area pain, x 24 hours persisting at time of visit
28 2021-04-05 mouth itchiness Pt arrived to observation area post first pfizer covid vaccination. Pt. Presented in observation wit... Read more
Pt arrived to observation area post first pfizer covid vaccination. Pt. Presented in observation with no symptoms and sat down in chair. At 2:12 pm patient raised hand for assistance. At that time patient stated that she was "dizzy." When asked if she felt going to pass out she replied, yes. Patient was placed on the floor with her head down and feet up. Patient continued to complain of dizziness and numbness in her feet. Placed pulse ox on Patient. HR 53 O2 93, Patient continued to be alert, but was having difficulty remembering her age and previous symptoms persisted and she stated she initially felt itchiness in her mouth and throat. At 2:18 EPIPEN was given IM 0.3mg Left anterolateral thigh (Lot #0GM229 EXP 12/21). Ambulance was called. 2:20 BP 110/68 HR 78 02 95. Patient began to state her symptoms were improving still complaint of tingling in fingers and legs. Able to answer questions appropriately. She was returned to sitting in the chair. 2:23 BP 100/70 HR 85 o2 100%. Patient remained alert and oriented Heart rate and pulse remained stable. 2:30p Paramedics arrived, Patient was taken to hospital via ambulance.
28 2021-04-06 eye pain, eye swelling Headache Sore neck Sore arm Sore armpit Sore throat Right eye swelling and pain
28 2021-04-06 ringing in ears Ringing in ears on and off about every 3 days.
28 2021-04-07 loss of taste Nasal congestion and loss of taste several days after having lunch with a friend who later tested po... Read more
Nasal congestion and loss of taste several days after having lunch with a friend who later tested positive for COVID. She tested positive for COVID on 4/7/21
28 2021-04-07 swollen tongue, mouth tingling Mild swelling of the tongue, flushing/sweating, tingling in the mouth. BPs 117/81 (pulse 84), 98/68.... Read more
Mild swelling of the tongue, flushing/sweating, tingling in the mouth. BPs 117/81 (pulse 84), 98/68. Patient felt anxious. O2 sat 98%.
28 2021-04-07 swollen tongue Anaphylactic reaction, throat swelling, tongue swelling, confusion - Epi pen administered 15 minutes... Read more
Anaphylactic reaction, throat swelling, tongue swelling, confusion - Epi pen administered 15 minutes after the vaccine and transported to the ER via ambulance. Gave me Benadryl, zofran, headache medicine, fluids
28 2021-04-07 thirst Headache, very thirsty. Drank more water and sat down and symptoms went away after a couple hours
28 2021-04-08 eye swelling 8 days after getting the Pfizer COVID-19 vaccine i got a tingling headache on the right side of my h... Read more
8 days after getting the Pfizer COVID-19 vaccine i got a tingling headache on the right side of my head near my temple and the next day it spread to my whole right side of my head, creating a painful bed-ridden migraine. The next morning after that, the 3rd of April it turned into a rash that eventually turned into blisters and went down to the tip of my nose, down my forehead and near my eye, to which it swelled. I went to the doctor to get help and was diagnosed with shingles a day afterwards. I have gotten medication and am still on it to this day (currently 4/9/2021)
28 2021-04-08 ringing in ears Dizziness, confusion, aches, bone pain, headache, fatigue, tinnitus
28 2021-04-09 oropharyngeal discomfort, ear discomfort looked in throat and noted it was red but not swollen; throat felt uncomfortable/throat fells like w... Read more
looked in throat and noted it was red but not swollen; throat felt uncomfortable/throat fells like when she eats olives; ear drums felt pressure; This is a spontaneous report from a contactable nurse. A 28-year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK8727 and expiry date was not provided), via intramuscular route, in deltoid left, on 25Mar2021 10:00, as single dose for COVID-19 immunization, at School or Student Health Clinic. Medical history included allergies to Black Olives. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient received the vaccine in her left deltoid, on 25Mar2021 at 10:00 AM. Patient went and sat to wait 15 minutes, when she came back up to the injection station saying her throat felt uncomfortable, and her ear drums felt pressure. Nurse looked in throat and noted it was red but not swollen. SPO2; 98%, HR; 84, BP; 123/64 on 25Mar2021 at 10:17 AM. Patient stated that throat fells like when she eats olives. Patient was given the choose of a friend driving her to an urgent care or we call 911. Patient wanted the friend to drive her to urgent care. Symptoms not getting worse. Left with friend to go to Freedom. The patient was the not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. Patient had physician office visit for the events. It was unknown treatment received for the adverse event. Outcome of the events was unknown. Information about batch number and expiration date has been requested.
28 2021-04-09 sensitivity to light Patient received second dose of Pfizer-BioNtech Covid-19 vaccine today and after 5-7 minutes reporte... Read more
Patient received second dose of Pfizer-BioNtech Covid-19 vaccine today and after 5-7 minutes reported to a pharmacy technician she was feeling nauseous. Patient wanted to keep her head down because she experienced light sensitivity; I placed cold compresses on her neck. Patient worsened over the next 10 minutes, complaining of feeling dizzy, anxious, intense headache. At this time, 15 minutes after being vaccinated, I (the vaccinating pharmacist) moved the patient to a private booth to have her lie down on the floor with her feet elevated. The patient was able to communicate the entire time and called her relatives to come pick her up from work. Emergency services were called as the patient was not experiencing anaphylaxis, but was increasingly more anxious and was afraid she'd fall or faint. Emergency medical services arrived after the patient had been laying down with feet elevated for almost 30 minutes. Patient did not complain of trouble breathing but did request use of her inhaler. Patient did not state on her patient questionnaire and consent form that she has asthma; she mentioned this during her episode. Patient was taking to a local hospital.
28 2021-04-09 ringing in ears felt very faint; lost visual clarity; profuse sweating; ears ringing; severe dizziness; heart palpit... Read more
felt very faint; lost visual clarity; profuse sweating; ears ringing; severe dizziness; heart palpitations; tension in my throat; severe nausea; This is a spontaneous report from a contactable consumer (patient) who reported for herself A 28-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN5318), in left arm on 25Mar2021 at 14:30 (at 28 years) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Mar2021 at 14:30 (as reported) the patient felt very faint, lost visual clarity, had profuse sweating, ears ringing, severe dizziness, heart palpitations, tension in her throat and severe nausea. Events were also described as follows: about 2 mins after (as reported) felt very faint, lost visual clarity, profuse sweating, ears ringing, severe dizziness, heart palpitations, tension in throat. Remained for about 5-10mins. Then severe nausea. No treatment given for the events. The final outcome for all the events was reported as recovering.
28 2021-04-10 mouth tingling, visual impairment tongue and lip tingling then swelling sweaty palms nausea bladder and fecal incontinence black out/ ... Read more
tongue and lip tingling then swelling sweaty palms nausea bladder and fecal incontinence black out/ loss of vision vision coughing labored breathing complete throat swelling burning all over resulted in epi pen usage then admitted to the emergency room
28 2021-04-10 enlarged tonsils Extremely sore throat, burning tonsils and sensations of tonsils "popping", fever feeling, chills, w... Read more
Extremely sore throat, burning tonsils and sensations of tonsils "popping", fever feeling, chills, weakness, fog, hurbing nasal passage and post nasal drip
28 2021-04-11 loss of taste Patient was around a friend on 4/3/2021, who later tested positive for Covid-19. This friend had re... Read more
Patient was around a friend on 4/3/2021, who later tested positive for Covid-19. This friend had received the first vaccination of the series. On 4/6/2021 Patient started to experience symptoms of sneezing and runny nose. She thought it was her allergies. During the day on 4/7/2021, she started having loss of taste and body aches. Patient was tested for Covid-19 on 4/8/2021 and tested positive. Patient has been fully vaccinated.
28 2021-04-11 smell distorsion, taste disorder I am experiencing an odd smell/taste in the back of my throat. It's been constant, even after brushi... Read more
I am experiencing an odd smell/taste in the back of my throat. It's been constant, even after brushing and using mouthwash. (It smells like smoked garlic!) I haven't lost any sense of taste or smell, however. It's just an added sense on top of what I already smell.
28 2021-04-11 vision blurred patient reports feeling lightheaded and weakness, sees spots/blurry film, cheeks flushed, patient b... Read more
patient reports feeling lightheaded and weakness, sees spots/blurry film, cheeks flushed, patient began to report focal muscle tenderness under her left armpit. Symptoms resolved about 40 mins after vaccination.
28 2021-04-11 visual impairment patient was exiting facility. she felt lightheaded, dizziness, and was seeing spots. pt became diaph... Read more
patient was exiting facility. she felt lightheaded, dizziness, and was seeing spots. pt became diaphoretic, she denies LOC. she was brought into obvs via wheelchair. she required assistance onto stretcher. pt was place in Trendelenburg position. reports improvement of symptoms once repositioned. pt was alert and oriented after placed on stretcher. pt was offered and accepted water. VS @ 15:26 : bp: 87/51 hr: 62 rp: 20 o2sat: 97% on RA VS @ 15:32: bp: 96/58 hr: 66 RP: 18 o2sat: 97% on RA Orthostatic VS Lying: bp: 89/56 hr: 83 o2sat : 99% on RA. sitting: bp: 105/60 hr: 72 o2sat: 100% on RA. standing: bp: 93/65 hr: 75 o2sat: 100% on RA. VS @ 15:42: bp: 93/65 hr: 75 rp: 17 o2sat: 100% vss @ time of discharge. pt escorted to exit via wheelchair with staff. no s/s of distress noted.
28 2021-04-12 taste impairment, mouth tingling PT C/O "funny taste" in mouth and tingly tongue. States had similar reaction to the 1st dose but d... Read more
PT C/O "funny taste" in mouth and tingly tongue. States had similar reaction to the 1st dose but did not tell anyone. feeling isolated to midline of tongue, no N/V/D Given PO Benadryl 50mg @1655, denies swelling or SOB. house PA to observation to examine pt.
28 2021-04-12 ear discomfort Immediately upon getting the dose, I fainted and felt as though my ears were popping. This feeling h... Read more
Immediately upon getting the dose, I fainted and felt as though my ears were popping. This feeling has only gotten worse and it feels as though my ears have too much pressure in them (like I?m underwater)
28 2021-04-12 lip swelling, swollen tongue Day 1 (4 hours after vaccine): Hives breakout all over body (legs, arms, stomach, back), pain in ste... Read more
Day 1 (4 hours after vaccine): Hives breakout all over body (legs, arms, stomach, back), pain in sternum Day 2: Pain in sternum, hives on arms Day 3: Swelling of lips, tongue and throat closure, hives all over body - went to urgent care Day 4: Swelling of lips, hives all over body, shortness of breath, pain in sternum Day 5: Hives all over body - blotchy, pain in sternum Day 6: Hives covering arms and legs, pain in sternum
28 2021-04-12 visual impairment Client received the COVID vaccine (Pfizer dose 2, lot #ER8731, expiration date 07/2021) at 1050. Cli... Read more
Client received the COVID vaccine (Pfizer dose 2, lot #ER8731, expiration date 07/2021) at 1050. Client reported feeling hot, seeing spots, and having a "pounding heart" right as she got vaccinated. EMT and RN responded at 1055. The client appeared flushed and diaphoretic. Vital signs were blood pressure 125/95, heart rate 120, O2 96%, respiratory rate 16. The client denied any shortness of breath or dizziness. The client has no allergies, her only medical condition is anxiety, and her only medications are her birth control and xanax as needed. The client stated they did not take any xanax previous to their appointment. The client stated that they did eat breakfast that day. The client was sitting in her chair comfortably in no distress. They refused benadryl at this time. At 1100, vital signs were as follows: heart rate 115, respiratory rate 14, and O2 95%. The client was alert and oriented, and denied needing any water. She stated that her symptoms were resolved and she was feeling "back to normal." At 1105, the vital signs were as follows: blood pressure 118/82, heart rate 97, respiratory rate 16, O2 99%. Education provided regarding emergency management and AMR activation, v-safe, and primary care follow up. At 1120, the client finished their 30 minute observation, and stated they had no remaining symptoms. Their color had returned to normal and they were no longer diaphoretic. They were able to stand and ambulate without any dizziness. Final vital signs were as follows: blood pressure 120/92, heart rate 92. The client was escorted to their car by the EMT, ambulated with a steady gait.
28 2021-04-14 loss of taste, loss of smell 12/22/2021 Pfizer Covid #1 EK9231 1:30p Left arm 01/12/2021 Pfizer Covid #2 EL3249 1:30p Left arm 4/... Read more
12/22/2021 Pfizer Covid #1 EK9231 1:30p Left arm 01/12/2021 Pfizer Covid #2 EL3249 1:30p Left arm 4/9/2021 ill 4/9 Covid PCR neg 4/12 Loss of taste/smell 4/13/2021 + Covid PCR
28 2021-04-14 loss of taste, loss of smell Patient received Pfizer COVID #1 on 2/1/2021 with Lot EL3247. Patient then received Pfizer COVID #2 ... Read more
Patient received Pfizer COVID #1 on 2/1/2021 with Lot EL3247. Patient then received Pfizer COVID #2 on 2/25/2021 with Lot EN6202. Patient reports nasal congestion since 4/12/2021 with associated headache. Denies fever, sore throat or cough. Patient has also developed loss of taste and smell. patient reports her boyfriend was positive for COVID earlier in the month. Patient arrived to our facility today and was tested for COVID using PCR.
28 2021-04-14 taste impairment With in a few minutes of the injection on 04/14/2021 I got a metal taste in my mouth, the left area ... Read more
With in a few minutes of the injection on 04/14/2021 I got a metal taste in my mouth, the left area of my lower jaw became numb, my throat felt itchy, my pulse skyrocketed and my chest constricted. I have a similar reaction with contract during a CT scan and didn't think much of it and assumed it would dissipate. As the day continued my chest began to feel tighter and I was having a difficult time breathing. I became easily winded walking 100 feet. About an hour later I was nauseous, had abdominal pain, fatigued, dizzy, pain at injection site and felt itchy everywhere. The numbness of my face disappeared about 3 hours later. My symptoms are still continuing as of 04/15/2021. As of 4/15 my breathing has been more labored, I've dizzy standing and sitting and eating has become more difficult. When I eat, I get the sensation that my throat is about to close. Otherwise, the rest of my symptoms have not gotten worse, but they also have not gotten and better. As of the afternoon of 4/15 I've begun taking Benadryl, if this does not lessen my symptoms, I will be speaking with a doctor.
28 2021-04-14 tongue discolouration, chewing disorder, mouth pain After the 1st dose, about a week or so afterwards I developed an awful painful red rash around my mo... Read more
After the 1st dose, about a week or so afterwards I developed an awful painful red rash around my mouth. It burned and was very uncomfortable. My lips started to peel off severely. I went to the dermatologist who tested samples for fungal, viral, and bacterial infections and they all came back negative. While we waited for the tests to come back she gave me an anti-fungal nystatin cream to treat the lips which within days cleared up the red/peeling. Then I got my 2nd dose on 04/05/21 and within a few days after that I started to develop pain and soreness inside of my mouth and white patches around my tongue, cheeks, etc. which made eating very uncomfortable. I went back to my dermatologist and she said it looked like oral thrush and has given me a nystatin mouth wash to use for the next 7-14 days.
28 2021-04-15 vision blurred Client reported lightheadedness, dizziness, blurry vision and diaphoresis. Visibly pale. V/S check... Read more
Client reported lightheadedness, dizziness, blurry vision and diaphoresis. Visibly pale. V/S checked by onsite EMS. BP 102/65, monitored for 10 minutes. BP reduced, 108/84. Monitored for 30 minutes. Reported, "I feel normal." Encouraged to follow up with emergency services and PCP as needed. Verbalized understanding.
28 2021-04-17 ear congestion, ringing in ears Ringing in ears and "stuffy" ears also headache.
28 2021-04-17 gaze palsy, visual impairment Patient presented to clinic today for 1st Covid vaccine. After receiving vaccine, patient complainin... Read more
Patient presented to clinic today for 1st Covid vaccine. After receiving vaccine, patient complaining of seeing "colored spots". Patient brought to reclining chair from waiting room. Patient has multiple comorbidity's - please see list in CMR. Patient's aunt in room with patient. 0807: Patient c/o having a "heavy face". VS 159/98, 89, 96% on RA. Patient denies any issues with breathing. Per patient when she swallowed some water, she felt as if it was hard to get down. Patient given 50 mg PO Benadryl (own supply). 0811: Patient stating that colored spots are now gone. VS: 169/95, 87, 98% on RA. 0817: VS 133/90, 96, 93%. Patient had small seizure in room; patient eyes rolled back, patient appeared to be non-responsive. Total time for seizure was approximately 30 seconds. After seizure, patient responsive and alert X3.
28 2021-04-17 mouth numbness, eye swelling Swelling my eyes significantly; Having my tongue go somewhat numb; Difficult to swallow; Feeling wor... Read more
Swelling my eyes significantly; Having my tongue go somewhat numb; Difficult to swallow; Feeling worse; Some feverish feelings; Hives all over my body, especially on my face; Chills; Couldn't stop shaking; This is a spontaneous report from a contactable consumer (patient, self-reported). A 28-year-old female patient (who was not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8732 and expiry date was not provided), via an unspecified route of administration, in arm left, on 26Mar2021, at 14:00 as single dose for COVID-19 immunisation. Patient medical history was not reported. She did not have any known allergies. Concomitant medications included estradiol valerate, progesterone and cyanocobalamin (VITAMIN B12). Patient stated that she first experienced some feverish feelings, chills and hives 30 minutes following her vaccination. She drove home from the hospital and was feeling a bit off, but mostly okay. By the time she got back, she was feeling worse, around 4 PM. By 5 PM she had broken out in hives all over her body, especially on her face, swelling her eyes significantly and having her tongue go somewhat numb, starting to make it difficult to swallow. She also had significant chills, and couldn't stop shaking, and ended up being admitted to the ER. After being given antihistamines, the swelling went down and eventually the chills stopped after monitoring in the hospital. The patient was hospitalized for the events on an unknown date in Mar2021. Treatment received for the events. The patient was not diagnosed with COVID prior vaccination. The patient had not been tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. Outcome of the events was recovered on an unknown date in Mar2021.
28 2021-04-17 mouth tingling, dry mouth, lip swelling 4pm (4.5 hours after vaccination) my arm became sore and stiff, fatigue set in. 6pm (6.5 hours after... Read more
4pm (4.5 hours after vaccination) my arm became sore and stiff, fatigue set in. 6pm (6.5 hours after vaccination), the fatigue was more severe, severe muscle, joint and bone pain, chills, headache. About 6:30pm (7 hours after vaccination) I developed severe vertigo and nausea with dry heaving. 7pm my lips and face felt strange, tingling and dry mouth. I don't know when my lips became swollen, but a friend saw and pointed it out to me at about 11pm. They remained slightly swollen and tingling at least 3:30am when I fell asleep. When I woke the tingling and swollen lips were completely back to normal, but the vertigo and other symptoms lasted until about 10pm on 4/17/2021. I am still fatigued and experiencing joint and muscle pain and injection site soreness, but I'm aware those are normal, expected side effects from this vaccine.
28 2021-04-17 ringing in ears This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient (... Read more
This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:15 AM (Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Historical bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 12:15 PM (Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine, irritable bowel syndrome (IBS), attention deficit hyperactivity disorder (ADHD). No covid prior vaccination, no known allergies and no covid tested post vaccination. The patient's concomitant medications included unspecified drug and not enough space. There is no other vaccine in four weeks. Patient experienced adverse events on 02Apr2021 included Arm Pain right after 02:00 AM, Headache around 2am, Nausea around 2:15am, Fainted around 2:20am, Weak Legs around 2:30am, Tingling in hand & feet around 2:30am, ringing in ear around 2:30am, Light fever around 7am, Headache persisting until just now after getting some sleep finally from 12pm-2pm now.AE resulted in Doctor or other healthcare professional office/clinic visit. There was unknown treatment were received for adverse events. The outcome of headache was not recovered. The outcome of other events was recovering.
28 2021-04-17 tunnel vision 2 MIN AFTER VACCINATION PT BECAME DIZZY AND REPORTS EXPERIENCING TUNNEL VISION. PT ASSISTED TO FLOOR... Read more
2 MIN AFTER VACCINATION PT BECAME DIZZY AND REPORTS EXPERIENCING TUNNEL VISION. PT ASSISTED TO FLOOR BY STAFF. TRANSPORTED TO MED OBS AT 1348 VIA STRETCHER. PT PLACED IN TRENDELENBURG POSITION. VSS. PT STATES SHE IS FEELING BETTER. PT SLOWLY TRANSITIONED TO A FLAT, SITTING AND THEN STANDING POSITION WITH NO ISSUES. ALL SYMPTOMS RESOLVED. PT RELEASED BY SELF AT1421. PT ESCORTED TO EXIT BY STAFF WITH NO FURTHER ISSUES. VITAL SIGNS AS FOLLOWS: 1400 BP 127/80 HR 61 SPO2 98 1406 BP 131/81 HR 61 SPO2 98 1410 BP 124/66 HR 62 SPO2 98 1415 SITTING BP 124/75 HR 71 SPO2 99 1419 STANDING BP 117/80 HR 75 SPO2 99
28 2021-04-18 dry mouth Extreme anxiety, nausea, dehydration, dry mouth, chills, tightness in chest, sore muscles in legs, t... Read more
Extreme anxiety, nausea, dehydration, dry mouth, chills, tightness in chest, sore muscles in legs, tiredness, dizziness, brain fogginess
28 2021-04-19 eye swelling, swollen tongue, lip swelling After 20 minutes, the tongue started to swell and lips. An hour later I had some hives on my stomach... Read more
After 20 minutes, the tongue started to swell and lips. An hour later I had some hives on my stomach. This continued for a couple of days. 5 days later my face, eyes, lips and tongue are swollen. Difficulty breathing at times.
28 2021-04-19 pain in jaw, ear pain I began noticing increasing pain beginning in my right arm, migrating up to my traps, base of my sku... Read more
I began noticing increasing pain beginning in my right arm, migrating up to my traps, base of my skull, sternocleidomastoid muscle, jaw joint (a lot of jaw popping) my neck (a lot popping, unusual), ears, and pecs. As well as this migrating to the left side of my upper body as well. Have been treating with heat, stretching, Ibuprofen, and Tylenol. As well as a lot of water. 4/16/21 - at around 7:00 pm I started noticing muscle stiffness on the right side of my body (shot was in R arm). However, the initial predicted side effects at this point were more noticeable than the pain in my neck. 4/17/21 - neck was basically immobile and both sides of neck seemed inflamed. around 9:00pm that night shoulders began to hurt more. 4/18/21 - had a little relief but was in pain. Noticed pain migrating to shoulder blade/trap area 4/19/21 - Pain had migrated to all places listed at the top. Heated, medicated, stretched, and massaged with little relief. Noticed on 04/20 that this pain was almost too much too handle. Had incredibly sensitive ears/pecs/sternocleidomastoid muscle. Went to work while at work I began sweating profusely, my equilibrium felt off, and I was at about a 9/10 in pain (unusual to the previous days.) My work environment is loud so I went to put in headphones which only made the symptoms worse. Could not focus, head feels 'full' and tired. I then was in so much pain that I did vomit. I called a dr and he did let me know that this is a heard of side effect. If things get worse or the vomiting doesn't subside to call again.
28 2021-04-20 loss of taste Sore throat, congestion, yellow mucus, cough (coughing up blood as well), headache, sneezing, no tas... Read more
Sore throat, congestion, yellow mucus, cough (coughing up blood as well), headache, sneezing, no taste
28 2021-04-20 eye pain Fever (chills, sweat, chills, sweat through the night), headache, body ache, aching behind eyes, bon... Read more
Fever (chills, sweat, chills, sweat through the night), headache, body ache, aching behind eyes, bone pain
28 2021-04-20 mouth tingling, swollen tongue The guest complained of a itchy throat and a tingling tongue. She does have a history of anaphylaxis... Read more
The guest complained of a itchy throat and a tingling tongue. She does have a history of anaphylaxis to dairy and carrots. She does have an epi pen but does not have one with her today. She stated that given her current symptoms she would not give herself an injection of epinephrine. At 1132 she was given 25 mg of Benadryl PO per standing orders . She stated that this helped and her tongue was feeling better. Guest drank water. The tongue seemed to be less swollen. Guest advised not to drive home given she had Benadryl in her system. 15 minutes after the first dose of Benadryl guest complained that she still had itchiness in her throat. She was given a second dose of 25 mg Benadryl per standing orders. Advised to follow up with her PMD regarding her second vaccine of Pfizer. .Guest remained for a total of 45 minutes before leaving with her husband.
28 2021-04-21 mouth tingling 10:27 am Pt stated she had tingling in her tongue. Pt was asked to stay an extra 10 minutes 10:50 am... Read more
10:27 am Pt stated she had tingling in her tongue. Pt was asked to stay an extra 10 minutes 10:50 am Pt stated shes feeling much better 0/10 scale no other symptoms. 10:55 am Pt left the site
28 2021-04-22 dry throat On 4/21 at approximately 1505, received her 2nd covid 19 vaccine (Pfizer, BioNTech lot ER2613) at he... Read more
On 4/21 at approximately 1505, received her 2nd covid 19 vaccine (Pfizer, BioNTech lot ER2613) at her desk, vaccine was given in right arm. She was going to be monitored by other MA's and Dr in area who was working with her at time of injection. At approximately 1513, calls clinic to report she has hives on her face and throat feels tight. Two RN responded to . RN reports had red rash on right side of face and itchy throat. Administered diphenhydramine 25mg IM right deltoid at 1525 and depo Medrol 80 mg IM right deltoid at 1528. After 15 mins of administration, reassessed and reports throat symptoms decreased. Check with patient at 1615. Patient reports throat symptoms have significantly improved and only dry throat. No difficulties breathing or swallowing noted. Assessed right cheek, no redness or hive noted. Patient reports her right cheek doesn't feel as tight as it did before. Patient sts Dr who she's working with will looked over her and helped direct her medication given as needed. She left work at 1740, prior to leaving denies any facial swelling, SOB, hives. On symptoms is fatigue. She has anaphalytic kit as home for home infusion for Crohn's therapy and for bee allergy. On 4/22-Called and spoke with patient and she denies any symptoms. She reports when she got home she ate dinner and went to bed. Woke up in the morning feeling great. Patient received her 1st covid vaccine (Pfizer, BioNTech lot EM9810) on 3/18/21 in right arm with no reactions. She did test positive for covid-19 on 3/26/21. She has recovered from covid-19 and returned to work on 4/4.
28 2021-04-22 swollen tongue Rash, facial swelling, tongue swelling
28 2021-04-22 toothache, pain in jaw, eye pain immediately post-injection: no noticeable reaction, effects, or symptoms. 6 hours post-injection: so... Read more
immediately post-injection: no noticeable reaction, effects, or symptoms. 6 hours post-injection: soreness in injected arm. 12 hours post-injection: exhaustion, nausea, vomiting, light-headedness, fever, chills, body aches, head ache, severe soreness in injected arm, weak. 18 hours post-injection: exhaustion, fever, chills, body aches, head ache, severe soreness in injected arm, weak. 24 hours post-injection: exhaustion, body aches, head ache, soreness in injected arm, weak. 30 hours post-injection: head ache, tooth ache, sinus pain, runny nose, eye aches, jaw aches. 36 hours post-injection: head ache, tooth ache, sinus pain, stuffy nose, eye aches. 42 hours post-injection: head ache, stuffy nose, sinus pain. 47 hours post-injection: stuffy nose. (this is the time that I'm writing these notes)
28 2021-04-22 tunnel vision Patient experienced a syncopal episode 10 minutes after receiving the Pfizer vaccine. Prior to passi... Read more
Patient experienced a syncopal episode 10 minutes after receiving the Pfizer vaccine. Prior to passing out she experienced diaphoresis and tunnel vision. EMS was called. Patient was found to have a low blood pressure. She felt nauseated while being evaluated by EMS. Was recommended to go to the ER. EMS transported patient to the ER. On the way to the hospital patient felt close to baseline. Once she arrived and found she would have to wait to be seen she left AMA.
28 2021-04-23 lip swelling Redness at vaccine site on 4/16/21. Redness started spreading on 4/18/21, with pruritic rash across... Read more
Redness at vaccine site on 4/16/21. Redness started spreading on 4/18/21, with pruritic rash across chest. Today developed rash extending onto neck, tightness in throat, and mild swelling of the lips.
28 2021-04-23 taste disorder, smell distorsion Around 24 hours after vaccine a red area about an inch in diameter from vaccine inj. Site became itc... Read more
Around 24 hours after vaccine a red area about an inch in diameter from vaccine inj. Site became itchy and slightly raised. Has been itching for 2 days and redness has not spread nor gone away. I also am experiencing different taste/smell like how I had when I was previously covid positive in December 2020.
28 2021-04-24 taste impairment Experiencing fatigue, joint pain, muscle pain, redness and pain at the injection site, headaches, ch... Read more
Experiencing fatigue, joint pain, muscle pain, redness and pain at the injection site, headaches, chills, bitter taste in mouth
28 2021-04-25 taste impairment, smell distorsion, taste disorder The day after I had received the vaccine, I experienced an intolerable taste and smell with certain ... Read more
The day after I had received the vaccine, I experienced an intolerable taste and smell with certain foods/drinks/mint- flavored things (toothpaste/chewing gum); certain things had a chemical/gasoline-like taste and smell. It seemed to get a little better after about a week, then returned to how it originally was, and has been ongoing since.
28 2021-04-25 mouth tingling shortly after receiving the vaccine, the patient reported shortness of breath, scratchy throat, and ... Read more
shortly after receiving the vaccine, the patient reported shortness of breath, scratchy throat, and tingling of the face and lips for which she was administered an adult epipen and 50mg benadryl by mouth. Vital signs obtained simultaneously demonstrated normotension and oxygen saturation greater than 98%. Her symptoms improved, vital signs remained stable, and she was transferred to the local ED by EMS. At the ED, her symptoms did not recur and she was discharged from the ED. She followed up late in the afternoon in the base clinic and reported resolution of her previous symptoms with only a lingering headache.
28 2021-04-26 teeth hypersensitivity Day 1 - 8:50am Soreness in left arm at injection site; 12:00pm Body aches Day 2 - 5:00am Fever, Tire... Read more
Day 1 - 8:50am Soreness in left arm at injection site; 12:00pm Body aches Day 2 - 5:00am Fever, Tiredness, Body aches; 8:00pm Tiredness, Body aches, Tooth sensitivity on upper left side of mouth Day 3 - 5:30am Soreness in left armpit, Tooth sensitivity on upper left side of mouth
28 2021-04-28 visual impairment Five days after Vaccine devoloped numbness in the left 4th finger that radiated into thumb and other... Read more
Five days after Vaccine devoloped numbness in the left 4th finger that radiated into thumb and other fingers lasted about a minute, Also had vision disturbances.
28 2021-04-30 painful gums, swollen gums Patient states that she developed 102 fever and gum swelling with pain. Also complains of submandibu... Read more
Patient states that she developed 102 fever and gum swelling with pain. Also complains of submandibular lymphadenopathy.
28 2021-04-30 pupils dilated fainted; dizzy; warm; arms had seized up and were twitching; leg and body had also briefly been shak... Read more
fainted; dizzy; warm; arms had seized up and were twitching; leg and body had also briefly been shaking; eyes were dilated; vomiting; arm is sore; sweaty; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:00 (Batch/Lot Number: Unknown) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination Medical history was reported as none. There were no concomitant medications. The patient previously had first dose of BNT162B2 (Lot number: ER8727) on 28Mar2021 01:00 PM in the left arm at 28 years old for COVID-19 immunisation and experienced fainted. On 18Apr2021 11:15 AM, the patient fainted about 10 minutes after second dose was vaccinated. The patient became dizzy and very warm and then woke up about 5-7 seconds after had fainted. The patient's arms had seized up and were twitching and leg and body had also briefly been shaking. The patient was very sweaty and warm. The patient's eyes were dilated when woke up according to the overseeing nurse. The patient said it was scary. Half hour after, the patient felt fine but then began vomiting when got home. The patient's arm is sore but nothing else has happened. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No treatment was given to the patient for the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
28 2021-05-02 extreme sound sensitivity, sensitivity to light Dizziness, Vertigo, Nausea, Fatigue, Soreness, Sensitivity to light and sound
28 2021-05-02 mouth swelling Received the first dose on 4/7/21 at 3:30 pm, no adverse affects. Received the second dose on 4/28/2... Read more
Received the first dose on 4/7/21 at 3:30 pm, no adverse affects. Received the second dose on 4/28/21 at 3:30pm, only a sore arm for the first 24 hours. At about 3:30pm on 4/29/21, began to feel a tightness in the chest, took my inhaler and it provided slight relief. At 3:30am on 4/29/21, throat began to swell so I went to the ER to get that checked out. They gave me Benadryl, a steroid shot, and some Pepcid for anti-inflammatory and provided prescriptions for when the medicines they administered wore off. From 5/1/21 until today, I have felt slight swelling in the throat and mouth and sinus areas, all manageable by prescriptions given. Today, 5/3/21, felt fatigue and headaches. There is still a bruise at the sight of injection, but no swelling there.
28 2021-05-02 ringing in ears, ear pain Ear pain and ringing in ear (tinnitus) very unbearable and loud, I had it for three days now. I can?... Read more
Ear pain and ringing in ear (tinnitus) very unbearable and loud, I had it for three days now. I can?t even sleep because of it.
28 2021-05-02 ringing in ears Left ear ringing, started 29 hours after injection. Ongoing.
28 2021-05-03 vision blurred I previously tested positive for COVID on 11/4/20. I had fever, chills, feeling of being very cold, ... Read more
I previously tested positive for COVID on 11/4/20. I had fever, chills, feeling of being very cold, cough, headache, rigors, fatigue, nausea, dizziness and was slightly short of breath one night. I recovered within two or so weeks. I was not hospitalized. I recieved my first dose COVID Pfizer vaccination on Tuesday, 4/13/21 at 1:10PM. On 4/16/21, I woke up around 8:00AM with blurred vision. I took out my contacts three separate times because I was convinced I kept putting them in wrong. As I was staring at the computer, my vision was very blurry and distorted. That night, I went to dinner with my father, a few other family members and friends. I kept remarking how my vision was blurry.
28 2021-05-04 loss of smell, loss of taste Difficulty breathing Fatigue Muscle or body aches Headache New loss of taste or smell Sore thro... Read more
Difficulty breathing Fatigue Muscle or body aches Headache New loss of taste or smell Sore throat Congestion or running nose
28 2021-05-05 loss of taste, loss of smell I had my second dose yesterday morning and I realized today I could hardly taste or smell things. I ... Read more
I had my second dose yesterday morning and I realized today I could hardly taste or smell things. I took a rapid and it said I was negative.
28 2021-05-06 deafness, blindness Around 7:45 pm 5/5 after getting the vaccine about 9:08 am 5/5 I started to get light headed, head ... Read more
Around 7:45 pm 5/5 after getting the vaccine about 9:08 am 5/5 I started to get light headed, head pounding and nauseous. My entire body ached and I was freezing. I could hardly open a water bottle do to severe weakness throughout my body which i've never had trouble with opening things. Throughout the night I had chills and then was hot then freezing and back and fourth. I tried to get up towards the morning a couple times and was extremely dizzy, weak, and nauseous. I started to have ringing in my ears and everything went black. I was able to lay down before passing out. Throughout the day 5/6 until about 5:00pm I couldn't move without getting very dizzy and nauseous and starting to lose hearing and vision. My heart beat on my fitbit was also tracking about 10 bpm faster than normal. Today 5/7 I am tired and still consistently nauseous throughout the day.
28 2021-05-06 lip swelling, mouth tingling, swelling of eyelid Patient presented to the ED 3 times for rash that started on face and went down to chest. Rash sprea... Read more
Patient presented to the ED 3 times for rash that started on face and went down to chest. Rash spreading to lower abdomen and under L>R breast. Swelling of face (lips, eyelids), neck area. Tingling of lips. Events started about 24 hours after 2nd dose of Pfizer vaccine. Differential: allergic reaction vs. reaction to vaccine vs. AED related hypersensitivity/rash vs. much less likely SJS. Dermatology consulted. Patient reports gardening on 4/18 and near weed whacking activities in an area that has poison ivy. Patient reports extreme sensitivity to poison ivy historically. Rash biopsy: differential diagnosis includes drug reaction and allergic/irritant contact dermatitis. Presence of a couple days of treatment may hinder histologic features for diagnosis.
28 2021-05-06 ringing in ears Tinnitus
28 2021-05-06 vision blurred, visual impairment Seeing black, spotty eyesight, almost passing out but was able to make it back to bed to lay down tw... Read more
Seeing black, spotty eyesight, almost passing out but was able to make it back to bed to lay down twice. Cannot stand or walk for longer than a couple of minutes unassisted (holding onto something) without breathing becoming shallow and dizziness setting in. Intermittent dizziness and inability to focus eyesight occurred throughout the day even if sitting down. Issues have been consistent throughout entire day. Not sure if this is adverse but also started having circulation issues in toes/fingers turning white & numb when either standing, walking or lying down. Experienced chills but only until ceiling fan was turned off. Circulation slightly improved except in feet.
28 2021-05-07 hearing loss, ear discomfort Right side of head and right ear feel muffled. Feels like right ear needs to pop but it won?t. Sound... Read more
Right side of head and right ear feel muffled. Feels like right ear needs to pop but it won?t. Sound isn?t as clear for the right ear as it is for the left ear. Never had any hearing issues previously.
28 2021-05-08 eye pain, eye swelling, vision blurred The week of 3/28/21 I began to feel numbness on the right side of my body, in my genital area. By 4... Read more
The week of 3/28/21 I began to feel numbness on the right side of my body, in my genital area. By 4/18/21, the numbness had spread into my right glute, which was completely numb. On Sunday, 4/25, I had a sudden onset of all of the following:, the numbness had spread upward and downward and the right side of my body was partially numb; vision in my right eye was blurry; my right eye hurt, and felt swollen; my pupils were unequal; my neck was stiff; I was dizzy; and I could not speak properly. I felt very floaty. These symptoms waxed and waned, together, for several hours at a time, getting progressively worse each time. My lucid periods also got progressively worse. I went to my PCP who ran bloodwork and referred me to a neurologist, who I could not get an appointment with until July. On 5/3/21, I was admitted to the ER based on the recommendation of the triage nurse who heard my symptoms and their duration. The ER ran a bunch of tests and found nothing. I went home and over the next few days entered again into several nonlucid states. I believe my body was getting closer and closer to death. I began taking my temperature with a reliable thermometer, and found it was dropping to 93-95 during my symptomatic periods. I found help from alternative doctors who immediately intervened, and continue to monitor me. The doctor I listed on this form was my ER doctor.
28 2021-05-09 mouth tingling, mouth numbness, burning mouth syndrome, taste impairment, swollen tongue, bleeding gums, eye pain, taste disorder Began with cramping, pains, and prickling in left leg and foot 4 days after receiving vaccine. That ... Read more
Began with cramping, pains, and prickling in left leg and foot 4 days after receiving vaccine. That was followed by pain all over (possibly lymph), sore eyes, sinus pain, stomach burning, migraine with numbness on one side, neck and chest pain and burning began 10 days after vax followed by painful/swollen tongue that turned numb and tingly, buzzing throughout body. Day 11 after vax I?m coming down with tingling and numbness in jaw and head and a pinny feeling in parts of head followed by numbness in throat, zapping up the neck, prickling pain when I pee. At Day 11 mucus is flowing down my throat. Chest and neck hurt at 12 days after start of symptoms. Body overcome by numbness, tingling, burning, and pain. Chest pain and palpitations cause me to seek emergency care the morning of May 7 and am referred to neurologist. Later that day I have uncontrollable shakes, burning in back of head that started in back and then spread to front and then turned to numbness, numbness/tingling spread to face, neck, chest, arms, and legs, pain in joints, swelling nose. May 8 I have bleeding gums, clumsy walking, burning sensations in face and chest, neck, and knees, followed by heart pain and intense heart palpitations that feel like my heart is clenched in a fist and isn?t being let go and uncontrollable shaking. Went to ER in ambulance. Have not felt symptoms since being treated with Prednisone, Famatodine, Benydryl, and Valium. Still some residual pain however. Other notable symptoms: water tasting sweet and metallic taste in mouth.
28 2021-05-09 vision blurred Missed menstrual period ongoing, last cycle 3/24/21 with multiple negative urine pregnancy tests. Di... Read more
Missed menstrual period ongoing, last cycle 3/24/21 with multiple negative urine pregnancy tests. Dizziness and blurred vision also experienced shortly after administration.
28 2021-05-10 ear discomfort On and off neuropathy in hands and feet; Right ear sensitivity / "popping", like with changing air p... Read more
On and off neuropathy in hands and feet; Right ear sensitivity / "popping", like with changing air pressure,; Slight woozy/dizziness; Injection site soreness; tingly outside of left arm / left pinky; Very mild headache; tiredness; Stiff / sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; slight numbness/ Slight numbness in pinky fingers on both hands, and left toes; General "not feeling good"; nausea; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:45 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. Medical history included developmental trauma disorder, drug allergy, allergies certain adhesives, borderline personality disorder, and irritable bowel syndrome. Patient is not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient experienced very mild headache, and mild tiredness were on 06Apr2021. On 07Apr2021 (day 2), patient was experienced injection site soreness, tingly outside of left arm/ left pinky. During day 6-7 (in Apr2021), patient experienced headache, stiff / sore neck (including upper shoulder area) left side of left arm and leg including hand and foot, tingly and slight numbness, general "not feeling good", slight nausea/ need to lie down, but not fatigue / wooziness. No fever. On 13Apr2021 (day 8), patient experienced slight woozy/dizziness, in waves. Slight numbness in pinky fingers on both hands, and left toes. On 14Apr2021 (day 9), on and off neuropathy in hands and feet, specifically left leg from knee down (outside of left toes and bottom of left foot) and pinky fingers, most notably when falling asleep/ waking up, or after being on my feet for a while. Right ear sensitivity/ "popping", like with changing air pressure, but on and off (most likely unrelated, but during same period). Adverse event result in doctor or other healthcare professional office/clinic visit. No treatment for events. The patient underwent lab tests and procedures which included saliva test: negative on 13Apr2021. The outcomes of events were unknown.
28 2021-05-10 vision blurred Full blown anxiety attack; Heart started to race, it felt like it want to come out of my chest.; Ey... Read more
Full blown anxiety attack; Heart started to race, it felt like it want to come out of my chest.; Eyes start to go blurry; Sharp back pain; Shortness of breath; Blood pressure high; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0162), via an unspecified route of administration on 15Apr2021 12:00 in the right upper arm at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: ER8733) on 25Mar2021 in the right upper arm for COVID-19 immunisation. Patient experienced a full blown anxiety attack. Her heart started to race, it felt like it wanted to come out of her chest. Patient also felt that her eyes started to go blurry and she had like sharp back pain and they put her on the stretcher and that mainly she had like shortness of breath with the main thing that she asked the nurse that people tended to get anxiety since they had been given initial of dose and she said no. Because of that nurse thought that patient should call Pfizer to report because nurse said that might be something like a side effect and they put her on the stretcher right away. Patient was on the stretcher for 40 minutes. These happened on 15Apr2021 13:00, an hour after vaccination. Patient did not receive treatment for events. She was given a whole bunch of water because she had like anxiety, the heart was racing fast, patient was kept on checking the high blood pressure until it went to low. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
28 2021-05-11 ear discomfort, deafness, ringing in ears and had pain; The caller thought the patient had allergies,; SEVERE hearing loss; ringing and pressu... Read more
and had pain; The caller thought the patient had allergies,; SEVERE hearing loss; ringing and pressure in her ears; ringing and pressure in her ears; This is a spontaneous report from contactable consumers (including patient herself and her mother). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left deltoid on 05Apr2021 (Batch/Lot Number: ER8733) as 1st dose, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Patient was not diagnosed with COVID-19 prior to vaccination. The patient had no health issues and was "perfectly healthy." The patient didn't want to get the vaccine but her mother said she needed to get it, so the patient got the shot. On 09Apr2021, four days after receiving the vaccine, the patient had ringing in her ears, then it was hard to hear, and had pain out of nowhere. She started having ringing and pressure in her ears, then lost hearing in one year. She went to the doctor and had a hearing test. She had 50% hearing loss in her left ear. The doctor ordered an MRI with contrast and without contrast and came out negative. Patient's mother thought the patient had allergies, although the patient never has allergies, so the patient took some Afrin nose spray and saline spray. They waited. Then it was the other ear. Patient started having trouble hearing/ can't hear out of ear. The patient's ears got worse then the patient started losing her hearing. Today, the patient felt that something was not right so she went to see and Ear, Nose and Throat doctor diagnosed the patient with severe hearing loss. The doctor kept asking the patient when she received the COVID vaccine because he had seen this in other patients who have received the vaccine. The doctor believes that the hearing loss was because of the vaccine because it started right after the patient received the vaccine. The doctor prescribed the patient a high dose of cortisone for 12 days and now he wants an MRI of the patient's brain with and without contrast. There was not a question that loss of hearing is a side effect of the vaccine. The doctor had seen this before and mother just wanted to know if she has to spend thousands of dollars, what happens? Does she need to go to the news? She wants to know what to do. Is the hearing loss temporary? What percentage had the reaction recovered from it? The patient's insurance was going to run out at the end of April and she will not be able to afford the treatment of this. What is going on? The event was so bad that the patient said she will not live like this- its a ringing and pressure in the patient's head and its driving the patient crazy, now its gone but she can't hear. The doctor had seen this before and patient's mother just wanted to know if the patient has to spend thousands of dollars, what happens? Does the caller need to go to the news? The caller wants to know what to do. She stated "I did my own research. Every time I googled hearing loss, it's everywhere about ringing in the ears. My daughter left her job and now we have medical bills and she has no insurance. Pfizer has not been very good with getting back to me. I need help for my daughter. I need financial help. They're thinking about killing themselves because of the noise in their head. This should really be out there to say that there's a good chance that you may lose your hearing and have sounds in your head that drive you crazy. People need to be educated to make the right decision for them. This should really be out there to say that there's a good chance that you may lose your hearing and have sounds in your head that drive you crazy. People need to be educated to make the right decision for them. My daughter left her job and now we have medical bills and she has no insurance." There has not been a new event. Patient had a MRI of the brain with and without contrast and it was negative. She used steroids and was not better. Outcome of hearing loss was not recovered, of ringing and pressure in her ears recovered on an unspecified date, of remaining events was unknown. The patient had not been tested for COVID-19 since the vaccination.
28 2021-05-11 eye itchiness Report tingling of spine, itchy palms and eyes tightness of chest, diarrhea 4 days after vaccination... Read more
Report tingling of spine, itchy palms and eyes tightness of chest, diarrhea 4 days after vaccination . Report the same symptoms as other medication she is allergic to. Treatment: Antihistamine Outcome: symptoms has resolved. Instructed by PCP not to get the second vaccine.
28 2021-05-11 mouth tingling, mouth numbness Approximately 10 mins after receiving 1st dose of Pfizer vaccine the patient reported tongue feeling... Read more
Approximately 10 mins after receiving 1st dose of Pfizer vaccine the patient reported tongue feeling bigger. On exam no swelling observed, skin warm and dry, speaking full sentences no drooling on drinking water, HR 60. Extended her observation to 30 mins. After 30 mins observation on reexamination the patient stated her tongue feels much bigger, lips are numb and it?s hard to swallow. Unable to appreciate abnormality on exam but based on patients concerns I called the ED shift captain. Dr in the ED advised I give the Epi and transport to ED. Epi administered at approximately 1445 hours into right outer thigh.
28 2021-05-11 feeling of choking, mouth tingling Pt here for 2nd dose of Pfizer. Pt states took 50mg of Benadryl. Hx of allergic reaction to 1st dos... Read more
Pt here for 2nd dose of Pfizer. Pt states took 50mg of Benadryl. Hx of allergic reaction to 1st dose, swelling throat and tickling sensation. Pt carries epipen as per PCP. PCP instructed Pt to take 50mg of benedryl 1 hour prior to vaccination. Pt did this. After dose today, Pt c/o tickle in throat and tongue. Pt noted to have horse speech but no other symptoms. PCP recommended taking additional 50mg benedryl if symptoms persist after 2nd dose. Called at 2:06pm. Arrived 2:10 and cleared at 2:12pm. Cleared for Pt to take another 25mg benedryl. Pt left at 2:35pm ambulatory and with speech back to baseline and driven home by husand. VS at 2:05 BP 146/90 HR 72 Temp 97.8F O2 sat 100% on RA VS 2:09 BP 112/70 HR 91 O2 sat 100% on RA
28 2021-05-11 sensitivity to light, eye pain First symptoms were sensitivity to light, eye pain, headache, fatigue, and woke up with chills durin... Read more
First symptoms were sensitivity to light, eye pain, headache, fatigue, and woke up with chills during the night. Day after vaccine: nausea, headache, pain in arm, stuffy/running nose, fatigue, light headed/dizzy, not hungry. Longer term effects felt 1 week after vaccine: abdominal and back pain (not associated with menstruation), dizziness, sensitivity to light, eye pain, fatigue
28 2021-05-12 ringing in ears Around 10:00pm, I started developing very intense chills and a fever. I went to sleep and awoke 2 ho... Read more
Around 10:00pm, I started developing very intense chills and a fever. I went to sleep and awoke 2 hours later with the loudest ringing in my left ear (tinnitus) and a fever of 104. The ringing in my ear was the most disturbing part. I knew it was being caused by a ton of inflammation near my ear, so for 7 hours I sat up and drank water (and tried not to panic about the sound). The ringing went away hours later, but my fever was still high at 7:00am. I got up to go to the bathroom and fainted. My twin sister -- who also got the vaccine with me (same batch) -- had fainted the night before. But her symptoms were not as intense as mine. My fever continued on and off for 48 hours.
28 2021-05-16 deafness, ringing in ears Severe Tinnitus and mild hearing loss that hasn't gone away.
28 2021-05-16 eye pain Fatigue, loss of appetite, muscle pain in legs and hips. Pain and spots in vison in left eye, still... Read more
Fatigue, loss of appetite, muscle pain in legs and hips. Pain and spots in vison in left eye, still happening three weeks later.
28 2021-05-18 thirst Entire left arm sore, fatigued,, Slight swelling in all body, increased thirst, Left eye experiencin... Read more
Entire left arm sore, fatigued,, Slight swelling in all body, increased thirst, Left eye experiencing subconjunctive hemorrage, taking ibuprofen and Benadryl, low discomfort
28 2021-05-20 feeling of choking Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify:... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: patient states her tongue and throat feel tingly similar to when she has reactions to peanuts, she states no difficulty breathing at this time.
28 2021-05-21 ringing in ears ear ringing; stomach and kidney pain; stomach and kidney pain; nausea; achiness; inflammation; light... Read more
ear ringing; stomach and kidney pain; stomach and kidney pain; nausea; achiness; inflammation; light headed; vasovagal response; some chest pain; collapsed/fainted; low grade fever; congestion; chills; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 06May2021 11:00 (Batch/Lot number: EW0170) as 2nd dose, single, at the age of 28-years-old for COVID-19 immunization. The patient is not pregnant. The patient had no known allergies. Medical history included a few kidney stones and one surgery to remove stones. She reported she was very healthy and active otherwise and hadn't had any sort of cold or illness in 2 years. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Apr2021 09:45 AM in the left arm as 1st dose, single for COVID-19 immunization. The patient did not have any other vaccine in four weeks and no other medications in two weeks. At 06May2021 9:00pm (10 hours after her 2nd shot), she started having a low grade fever, congestion, and chills. She went to sleep at 12:00am, chills and fever were more intense at this point. At 2:00am on 07May2021, she woke up with a fever of 103, no chills, but intense ear ringing (a volume of 9/10) in her left ear, extreme stomach and kidney pain, nausea, and achiness. The ringing in her ears was the worst symptom. She sat up and drank water for the next 5 hours, to try to get the inflammation down. She went to the bathroom every hour and her ear ringing started to lessen. At 7:00am she went to the bathroom for the 5th time and began to feel extremely light headed. She had a vasovagal response and collapsed/fainted (luckily, she had a family member who was monitoring her). She went back to rest and have had on and off low-grade fever, some chest pain, and aches since then. She has a twin sister, who got her shot on the same day and time, and she also had a vasovagal response, but not nearly as many of the other symptoms. The patient had no prior vaccination and was not tested for COVID post-vaccination. No treatment was received for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021521315 same reporter/drug, similar event, different patient
28 2021-05-23 eye twitching I have been experiencing eye-twitch since after vaccination till now.
28 2021-05-23 vision blurred 60 seconds after receiving first dose, patient reported symptoms of not being able to move both arms... Read more
60 seconds after receiving first dose, patient reported symptoms of not being able to move both arms, nauseous, dizziness, black spots/blurry vision, hyperventilating patient was given EpiPen injection & 911 was called EMT and paramedics arrived & said it was most likely anxiety related & patient looked much better after being calmed down thru breathing techniques patient was feeling and looking better after 15-20 minutes and opted NOT to go to hospital.
28 2021-05-24 eye itchiness 9 hours later, eye itching, redness, itching all over. Lasted a day. Minimal itching with second dos... Read more
9 hours later, eye itching, redness, itching all over. Lasted a day. Minimal itching with second dose, more achy.
28 2021-05-26 eye movement disorder, vision blurred, visual impairment eyes seemed to move quickly back and forth; felt weak and had no energy; heart began to beat fast li... Read more
eyes seemed to move quickly back and forth; felt weak and had no energy; heart began to beat fast like it was going to beat out of chest; shake all over her body; vision came back blurry; blood pressure and heart beat were high; vision went in and out while driving down the freeway; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received bnt162b2 (Pfizer product), dose 2 via an unspecified route of administration, administered in arm left on 06May2021 11:45 (Lot Number: Ew0175) as single dose for covid-19 immunisation. Medical history and concomitant medications were none. No any other medications the patient received within 2 weeks of vaccination. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of bnt162b2 (lot number: Ew0161) in left arm on 15Apr2021 at 11:30 for covid-19 immunisation. The patient previously took amoxicillin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stayed for 20 minutes after getting the second vaccine and was fine so she headed to work. A total of 40 minutes after vaccine (06May2021 12:25), her vision went in and out while driving down the freeway. At 12: 45, she started to shake all over her body and heart began to beat fast like it was going to beat out of chest. Her vision came back blurry and was able to pull over on the side of the freeway and call 911. They took her blood pressure and heart beat, both were high. After 30 minutes her heart beat and blood pressure returned to normal. For the remainder of that day the episodes happened 3 times, but only lasted 2-3 minutes at a time. Two days after (08May2021), her vision was blurry and eyes seemed to move quickly back and forth and she felt weak and had no energy. The adverse events result in Emergency room/department or urgent care. Unknown if treatment received. The outcome of events was recovered with lasting effects.
28 2021-05-26 eye swelling, vision blurred, mouth numbness, ear pain Head congestion; Left ear pain; Arm soreness; Chills; Blurred vision; Dehydration; Malaise; Sinus pa... Read more
Head congestion; Left ear pain; Arm soreness; Chills; Blurred vision; Dehydration; Malaise; Sinus pain in left side; Dizziness/lightheaded; Left side of face swelling; Lips and tip of tongue numb; Itchy around injection site; Swollen throat; Left eye discomfort/swelling; Tension pain in left side of neck; This is a spontaneous report from a contactable Consumer, a patient. A 28-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EL9266), via an unspecified route of administration in the Left arm on 20Feb2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID 19 immunisation. The patient's medical history included Asthma. The patients' concomitant medications were not reported. She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since the vaccination. On 20Feb2021 the patient experienced arm soreness, blurred vision, chills, dehydration, dizziness/ lightheaded, head congestion, itchy around injection site, left ear pain, left eye discomfort/ swelling, left side of face swelling, lips and tip of tongue numb, malaise, sinus pain in left side, swollen throat, tension pain in left side of neck. The patient did not receive any treatment for the events. The clinical outcome for the events arm soreness, blurred vision, chills, dehydration, dizziness/ lightheaded, head congestion, itchy around injection site, left ear pain, left eye discomfort/ swelling, left side of face swelling, lips and tip of tongue numb, malaise, sinus pain in left side, swollen throat, tension pain in left side of neck was recovered. No follow-up attempts are needed. No further information is expected.
28 2021-05-27 mouth numbness Patient is a 28-year-old, female. Alert, oriented X4, clear speech, able to answer to questions. Pat... Read more
Patient is a 28-year-old, female. Alert, oriented X4, clear speech, able to answer to questions. Patient denies having adverse reaction with first dose of Pfizer. Patient has no known allergies. Patient given 15-minute observation time with EMTs. At 1:53 pm, the patient received her second dose of Pfizer (lot number EW0187, expires on 08/2021) on right deltoid. At 2:22 pm, patient reports ?5/10? numbness of tongue and throat. Patient denies shortness of breath. Patient requesting IM Benadryl. EMT responded by taking patient's vitals while lead RN drew up IM Benadryl. At 2:24 pm: BP 145/93, SPO2 99%, HR 86. Patient was placed in anti-gravity chair and given water. Patient states she has ?a little? trouble swallowing. At 2:29 pm, RN gave patient 50 mg/1mL of IM Benadryl in left deltoid. At 2:33 pm: BP 160/109, SPO2 98%, HR 75. Patient denies SOB. Patient states numbness in throat and tongue is now a ?3/10?. At 2:38 pm: BP 159/105, SPO2 99%, HR 73. Patient describes numbness as a ?2/10? and her mouth feels ?almost back to normal?. At 2:44 pm: BP 164/98, SPO2 99%, HR 70. Patient states she is ?feeling fine? and denies symptoms of high blood pressure, such as dizziness and seeing spots. At 2:50 pm: BP 170/94, SPO2 99%, HR 83. Patient continues to deny symptoms of high blood pressure. At 2:57 pm, patient states her numbness is ?1/10?. Patient denies additional symptoms of adverse reaction. Patient states she would like to leave facility. Lead RN provided patient with education related to when to seek medical attention, such as seeing spots and feeling faint. RN advised the patient to stay at facility to continue to monitor blood pressure. At 3:04 pm: BP 159/106, SPO2 97%, HR 75. Patient states she will follow up with PCP about reaction and elevated blood pressure readings. Patient states her mother will drive her home. At 3:09: BP 144/90. Patient stood up from anti-gravity chair, denies dizziness and lightheadedness. Patient walked with steady, balanced gait to parking lot.
28 2021-05-28 ear pain 4 of 10 throbbing headache; left ear/lateral neck pain; left ear/lateral neck pain; This is a sponta... Read more
4 of 10 throbbing headache; left ear/lateral neck pain; left ear/lateral neck pain; This is a spontaneous report from a contactable other HCP reported that, A 28-year-old female (Non pregnant) patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: el3302), via Intramuscular route of administration in left arm on 14Jan2021 at 06:00 PM (at the age of 28-years-old) at Public Health Clinic/(Name) facility as a single dose for COVID-19immunisation. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: el1284), via Intramuscular route of administration in left arm on 23Dec2020 at 05:30 PM as a single dose for COVID-19immunisation.Patient medical history of the patient was not reported. The patient allergy history was not reported. Patient concomitant medications of the patient include ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL MULTIVITAMINS) taken by mouth, once a day. It was not reported whether the patient was diagnosed covid-19 before vaccination and if tested covid-19 after vaccination. On 14Jan2021, 45 minutes after receiving her second dose of covered vaccine, presents to urgent care complaining of a 4 of 10 throbbing headache and left ear/lateral neck pain. She has not taken anything for pain, having come straight from work/vaccination clinic. She tolerated her first dose of vaccine well. Ae resulted in [Emergency room/department or urgent care]. The patient underwent lab tests and procedures which included pain assessment: 4, on 14Jan2021. Therapeutic methods were taken that include tylenol 1000mg by mouth once, patient monitoring. The outcome of all the events was recovered. No follow up attempts are possible. No further information is expected.
28 2021-05-28 mouth numbness, mouth tingling Left arm became tingly, got hot and tingly all over, then face became itchy, then lips and tongue b... Read more
Left arm became tingly, got hot and tingly all over, then face became itchy, then lips and tongue became numb and tingly. All from 12:30 - 1pm (30 min to 1 hour post vaccination). Took 50mg Benadryl at 1pm. Symptoms continued to intensify until 3pm. Currently 27 hours post vaccination and experiencing sore site, itchy face, tingly lips and tongue.
28 2021-05-28 ringing in ears High Fever (104), Tinnitus, Felt like floating, Skin sensitive (pain) to touch things, Nausea, waite... Read more
High Fever (104), Tinnitus, Felt like floating, Skin sensitive (pain) to touch things, Nausea, waited it out, lasted 24 hours after onset. Most intense first 12 hours after onset. 4 hours previous to onset began to sense swelling and tingling internally -- like anaphylaxis
28 2021-05-31 drooping eyelid second shot; allergic reaction on left side (shot in left arm) - swelling of face, tingling fingers... Read more
second shot; allergic reaction on left side (shot in left arm) - swelling of face, tingling fingers and toes, mild throat swelling, droopy eye; took Benadryl per recommendation of pharmacist side-effects occurred 30 mins post shot
28 2021-06-01 eye itchiness, swelling of eyelid, bloodshot eyes Severe itching and redness in both eyes. Slight swelling in upper lids.
28 2021-06-01 taste disorder, taste impairment Since receiving the vaccine I have noticed that some foods taste different than they used to. Coca c... Read more
Since receiving the vaccine I have noticed that some foods taste different than they used to. Coca cola and artificial citrus flavors have a very chemical type taste.
28 2021-06-03 lip swelling, swollen tongue Upper lip swollen; tongue swollen; Very fatigue; sore throat; This is a spontaneous report from a co... Read more
Upper lip swollen; tongue swollen; Very fatigue; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 28-years-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 15Mar2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient previously received a first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the left arm on 24Feb2021 at 15:30 hours (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had allergy to shellfish. Concomitant medication included Tylenol for an unknown indication. The patient did not receive any other vaccine within 4 weeks prior to the covid-19 vaccination. The patient had not diagnosed with covid-19 prior to vaccination. Since the vaccination, patient had not been tested for covid-19. On 16Mar2021, the patient experienced swelling of upper lip and tongue, sore throat and felt very fatigue. Therapeutic measured included as benadryl and tylenol for the reported events. Clinical outcome of the events upper lip and tongue swollen, very fatigue and sore throat were resolving at the time of report. No follow-up attempts are needed and no further information is expected.
28 2021-06-08 lip swelling Stevens-Johnson syndrome; upper lip started to swell/lips were swollen/both lips swollen bad/top and... Read more
Stevens-Johnson syndrome; upper lip started to swell/lips were swollen/both lips swollen bad/top and bottom lips were very, very swollen/swollen lips; swollen lips and throat; hives on chin, shoulders and back/ had itchy hives all over/bad hives/hives on are the rest of the body/hives all over torso; This is a spontaneous report from a contactable consumer (patient) and other HCP (nurse). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in Arm Right on 06Mar2021 18:15 (Lot Number: EN6199) (at the age of 28 years old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history included bipolar disorder and depression, both from an unknown date. Concomitant medications included lithium; venlafaxine; hydroxyzine embonate (VISTARIL [HYDROXYZINE EMBONATE]); lithium carbonate; propranolol; venlafaxine hydrochloride (EFFEXOR); all were taken for an unspecified indication, start and stop date were not reported. The patient previously took lamictal and experienced allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 07Mar2021 (Sunday), that day after Pfizer COVID vaccine, patient had bad hives, woke up with hives on chin, shoulders and back. The hives continued on Monday (08Mar2021) to get worse, hives continued to get worse and then on Tuesday, woke up and lips were swollen. It was reported that 2 days after vaccine, her upper lip started to swell. Then 3 days after (on Wednesday), woke up and both of her lips were swollen, top and bottom lips were very, very swollen, both lips swollen bad. Stated that it was getting worse. And had itchy hives all over her body, hives on are the rest of the body, the hives have continued over the rest of her body. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Also reported by the other HCP that the adverse events: hives all over torso, swollen lips and throat started on 06Mar2021, which resulted in Emergency room/department or urgent care, the reported treatment received for the adverse event were Benadryl, steroids. When probed if the product was prescribed by any healthcare professional. Further stated, that she also had hives on her abdomen and on her legs. She tried taking Advil allergy and now she was taking a different allergy medication. Patient stated that one of the things her doctor was worried about was Stevens-Johnson syndrome. With the current symptoms that the patient had that were getting worse not better. She was wondering if she needed to go to a hospital for any assistance. The outcome of the event Stevens-Johnson syndrome was unknown while for the other events was recovering. Follow-up attempts are needed. Additional information is requested.; Sender's Comments: A possible causal relationship between BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the reported events, including swollen lips and throat and suspected Stevens-Johnson syndrome cannot be excluded, considering temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
28 2021-06-08 ringing in ears - pulsatile tinnitus in left ear after first dose worsened after second dose - after second dose, co... Read more
- pulsatile tinnitus in left ear after first dose worsened after second dose - after second dose, constant ringing in ears (both) - like crickets..still facing the same symptoms
28 2021-06-13 swollen tongue, lip swelling I got my vaccine around 11:40 am. Within 5 minutes of the vaccine, I could feel that my face was hot... Read more
I got my vaccine around 11:40 am. Within 5 minutes of the vaccine, I could feel that my face was hot and had tingling sensation under the skin around my cheek. I was sent behind the curtain with a Emergency doctor. At the time, the symptom did not get worse, so I was discharged. When I got back to my place and was in my meeting around 1:45 pm, something felt weird around my lips and my tongue. I could feel that my tongue was swelling, so as my lips I got scared so I took another dose of Xyzal. I could still feel that swelling was progressing. My colleagues told me that I was talking as if I couldn't feel my tongue and my tongue wasn't moving as I was talking. I remembered the doctor at the vaccine site told me to call 911 if the symptoms got worse. So I called 911, paramedics came. Epipen wasn't necessary, but I took another dose of Xyzal. Other than my blood pressure being shot up, my vitals were okay. They did confirm the allergic reaction but told me that they cannot confirm that it is from the vaccine. However, I have never had such a reaction in my life, I highly believe that it was from the vaccine. The swelling did not go away for 7 days. And during the time, I was taking at least 15 mg of Xyzal per day to keep the itchiness and swelling down. I reached out to my PCP and he advised not to get the second dose.
28 2021-06-14 vision blurred, drooping eyelid, double vision Fever, aches accompanied by blurred vision that turned into double vision over the first 24 hours af... Read more
Fever, aches accompanied by blurred vision that turned into double vision over the first 24 hours after shot. Diplopia and ptosis were severe and I visited the urgent care who sent me to emergency eye hospital May 14th, eye exam performed confirming diplopia and ptosis, and did bloodwork. Ordered CT scan that I completed June 4th,. Visited neuro opthamologist again June 10th, ordered emergency brain MRI and EMG. MRI completed June 11, EMG scheduled tomorrow June 16, diplopia and ptosis still present for the last 5+ weeks, everyday- all the time. Now, I have to wear an eye patch at all times to even kind of see.
28 2021-06-15 ear pain On June 8, 2021 at 2:30 AM, about fourteen hours after vaccination, I started feeling chills and pai... Read more
On June 8, 2021 at 2:30 AM, about fourteen hours after vaccination, I started feeling chills and pain throughout my entire body. From my fingertips to my toes, every muscle and joint was hurting. As a result, I was kept up all night from the pain. Hours later I began sweating and feeling feverish with a headache. Out of everything, the pain throughout my entire body was the worst thing next to the headache. Pain was an eight out of ten. I also had sporadic hot flashes along with inner ear pain. It wasn?t until June 11, 2021, that I felt the pain in my joints and muscles had subsided. Treatment included: Tylenol, Excedrin, Pain Relief Medication On Monday, June 14, 2021, exactly one week from vaccination, I awoke with really bad vertigo, inner ear pain, nausea, and sporadic hot flashes. Symptoms coincide with vestibular neuritis. Treatment included: Excedrin, Dramamine, Tylenol, Naproxen Currently, on June 16, 2021, I am still having pressure in my head and behind my eyes, like a migraine, along with sporadic ear pain. There is still a slight dizziness but not complete vertigo. Currently taking Excedrin Migraine.
28 2021-06-20 ringing in ears, deafness One week after the second dose of the Pfizer COVID-19 vaccine (4/8/2021), I woke up with loud bilate... Read more
One week after the second dose of the Pfizer COVID-19 vaccine (4/8/2021), I woke up with loud bilateral tinnitus, which has not stopped since. Working with three different doctors (Primary Care, ENT, & Audiologist), I have tried courses of oral steroids, oral antibiotics, antibiotic ear drops, oral antivirals, over-the-counter ear ringing drops, and over-the-counter ear ringing tablets. None of these medications have stopped the ringing. Per my Audiologist, I am presently trying sound therapy to mitigate the ringing before we proceed with hearing aids.
28 2021-07-02 loss of taste Loss of taste; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-... Read more
Loss of taste; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration on an unspecified date (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to pork, diary, beef and gluten. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. On 20Mar2021, the patient experienced loss of taste. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 22Mar2021 which included COVID-19 virus test and the test result was negative. The patient did not receive any treatment for the event loss of taste. The clinical outcome of the event loss of taste was recovering at the time of the report. No follow-up attempts are possible. No further information is expected.
28 2021-07-05 lip swelling, mouth discomfort, lip dry Per Director of Nursing: patient stated that the day she got the vaccine she also got her allergy s... Read more
Per Director of Nursing: patient stated that the day she got the vaccine she also got her allergy shot as she gets them 2 x a week. On Friday she woke up with fever, GI issues then her lips swelled and she got welts on them and she developed wheezing. She went to the ER on Friday, they gave her Benadryl , Prednisone and an antibiotic. On Sunday her lips were burning and swollen and burst open and started to bleed so she returned to the ER again. She states she is feeling better now but her lips are scabbed and dry. She stated that the ER doctor wasn?t sure if she may have had a reaction to the allergy shot in combination with the vaccine.
28 2021-07-08 visual impairment I reacted to the first vaccine, the health department took me to the hospital. I was monitored immed... Read more
I reacted to the first vaccine, the health department took me to the hospital. I was monitored immediately having trouble breathing, took Benadryl, used my inhaler but then after that I started having problems to allergens that were not a problem before. I ended up needing an epi pen, I started to have trigeminal episode where it started to have them everyday. I also had fibromyalgia every day, pain scale 7 out of 10 on VAS scale. I ended up going to the doctors where they tried different medications. I started getting heavy periods and my birth control medication I had been out for 7 years, stopped working. I have lost a lot of weight, about 40 pounds. I was having migraines pretty much every day. I also started to get on one side of my face, left side. Then the same started happening to my right leg. I started to have vision problems, where me the sides of my eyes would go black and cracks in my vision. I went to the neurologist, ophthalmologist and no one had been able to figure out what is wrong with me. I have not been able to work for months. I was pretty active before the vaccine, I worked with a cancer institute for kids, but now I could not perform my daily activities, got so sick all the time. I had to move back with my parents. I still have pain a lot of the time, I do not have Covid and my symptoms have been pretty horrible since receiving the vaccine. I've had blood panels done, eye exams, MRI of the brain and pap smears but the exams are all negative and can not find the reason to my symptoms. No spinal tap yet done. Also my asthma is not under control and I get winded when going up a flight of stairs. I do not have the lot# to provide today.
28 2021-07-09 visual impairment Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemi... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Fainted after vaccine administered (about 10minutes) Fell out of chair and hit head on a shelf. EMT were called and patient released on her own accord.
28 2021-07-14 enlarged tonsils On Friday night I had increased heart rate and couldn't catch my breath. The ambulance came and did ... Read more
On Friday night I had increased heart rate and couldn't catch my breath. The ambulance came and did an EKG where everything was normal. They took me to the ER. When I got there, they wheeled me out into the waiting area. While I was there, I was sitting there for about 2-3 hours. I noticed that my heart rate was not spiking anymore, and my breathing was better. I asked to be discharged without being seen. On 4/19, I went to pick up my daughter after a walk. When I got back, I was gasping for air and had chest pain. I went to the ER where they told me I had an elevated D dimer. They referred me to a cardiologist. They did all the CT scans and said they did not see anything, so they discharged me. On 4/14 I saw the cardiologist, who said he does not think it was due to pericardial effusion/pericarditis which I was diagnosed with after the birth of my daughter in June 2019. He had done an echo which was normal in October. I also saw my PCP where my blood pressure medication was changed to amlodipine and I was referred to a pulmonologist. I saw doctor who did a bunch of tests and did not find anything. He suggested I had costochondritis and put me on Toradol and an asthma pump. The asthma pump did not help. On 5/7, I had extreme chest pain where I could not move my arm. I went to the ER where they did a scan of my heart to check for fluid and a D dimer test. Since receiving the shot, I noticed my tonsils would swell up after eating. I had to stop eating and went on an ensure diet. I went to an allergist that said I was severely allergic to rice, a dog, but I was never allergic to anything before. I went back to the cardiologist where the PA said even though there is nothing wrong, maybe there is unseen myocarditis or pericarditis. The medication messed with my stomach. I went to check that everything was fine with my lungs where everything was deemed fine. On 5/27, I did a stress test which was fine. On 6/2, I had experienced shortness of breath again. I was unable to work normally and had to stop working. Doctor did tests for inflammatory diseases Mitochondrial M2 antibodies was in the middle range. This is inconclusive. I went to doctor who ran a lot of tests and found that Sedimentation rate was too high, Comprehensive metabolic rate was normal, CMV Igg: positive. He said perhaps I have long haul COVID. The antibody test showed I was positive for the vaccine antibodies but not the true COVID antibody. He suggested it could be an inflammatory issue. I saw an ENT for my throat who put me on antibiotics. The antibiotics helped but when I got off, I had another flare up. I was put on more antibiotics. On 6/29, I went to another cardiologist who did a contact MRI. He saw a swollen left atrium but said it was overall normal. I also saw a pulmonologist to notify them that the shortness of breath is still sometimes present. I saw a GI who did a test and found that I had erosive gastritis. I was taking metoprolol and tarivid. I still have stomach discomfort.
28 2021-07-16 lip swelling, swollen tongue Within 15 minutes, around my cheek started swelling, confirmed by the nurse. Then around my face sta... Read more
Within 15 minutes, around my cheek started swelling, confirmed by the nurse. Then around my face started swelling then my lips. About an hour later, my tongue started swelling, but I was already admitted to the ER and was given an IV Benadryl and steroids. I was discharged at 4:30 PM. Around 10 PM started noticing purple-ish rashes on my right arm and left leg.
28 2021-07-17 blindness, eye floaters, vision blurred, eye pain Vision loss; Gets worse daily; Eye pain; Eye inflammation; Floaters; Blurry; headache; This is a spo... Read more
Vision loss; Gets worse daily; Eye pain; Eye inflammation; Floaters; Blurry; headache; This is a spontaneous report from a contactable consumer (reporter herself). A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot Number: EN6206), via an unspecified route of administration, administered in arm left on 18Mar2021 11:00 (age at vaccination 28-year-old) as dose 1, single for covid-19 immunisation. Facility where COVID-19 vaccine was administered in military base. Medical history included (POTS) postural orthostatic tachycardia syndrome and factor v leiden carrier. Concomitant medications included lorazepam (ATIVAN), metoprolol tartrate and acetylsalicylic acid (ASPIRIN (E.C.)) for unspecified indication received within 2 weeks of vaccination. The patient previously took nifedipine (PROCARDIA) for allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vision loss, gets worse daily, eye pain, eye inflammation, floaters, blurry, headache on 20Mar2021. Since the vaccination, the patient was tested for COVID-19. The patient lab test included sars-cov-2 test (nasal swab) was pending on 05Jul2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The treatment for the events were several doctors, ER (emergency room) visit, urgent care visits. The outcome of the events not resolved.
28 2021-07-17 ear pain Diarrhea; felt hot on her left side of her body then her complete body felt hot; felt like her entir... Read more
Diarrhea; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Lightheadedness; Weakness; Severe Headache; Left ear was hurting; Chest Tightness; chest feels funny; Throat Tingling and Tightness; Throat Tingling and Tightness; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Chills; disoriented really bad and confused and had a bit of a blurred mind; disoriented really bad and confused and had a bit of a blurred mind; Feels Very Off; Blood Sugar Level Dropped Below 60; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female consumer received first dose of bnt162b2 (Solution, injection; Batch/Lot Number: EW0164) via an unspecified route of administration, administered in Arm Left on 21Apr2021 at 08:35 as single dose (at the age of 28-years-old) for covid-19 immunisation. Medical history included drug hypersensitivity penicillin and anything that is a cousin to penicillin. She did not have any prior vaccinations within 4 weeks. There were no concomitant medications. She stated that she took the vaccine at 8:30 by 8:45, she felt very lightheaded and she signaled the nurse, and she was brought into a room. She stated that she took the shot in her left arm. After the vaccine it was like she was disoriented and confused and had a bit of a blurred mind, like she felt confused. States she thought she would be up and ready after but they put her to lay down. Caller states she was disoriented really bad. She felt her left ear hurting and then tingling in the front of throat and her throat and chest began to get tight. She stated that as she was trying to drive home, she had to pull over and she felt like her entire body was on fire. She stated it was on and off. She gets really hot inside and starts to sweat and had cold chills and then it goes away and comes back. She stated she felt hot on her left side of her body then her complete body felt hot until 10:00 PM. She felt hot and weak to the point that couldn't drive this morning. She stated her blood sugar level had dropped to below 60. She stated that many of her side effects come and go, they don't last very long. She was treated with Tylenol. She stated that she was in observation under a tent after her vaccine. On 21Apr2021, in the morning she still feels hot and now had diarrhea, severe headache, her chest feels funny and she felt very off. She asked is it common to have diarrhea. She stated that her main concern is if she should take the second dose since she had this reaction with her first dose. The outcome of all the event was not recovered while the outcome of the events disoriented really bad and confused and had a bit of a blurred mind and left ear hurting was recovered. No follow-up attempts are possible. No further information is expected.
28 2021-07-17 mouth discomfort Red flushing cheeks at time of shot; swollen glands in neck; extreme pain in front of neck; shortnes... Read more
Red flushing cheeks at time of shot; swollen glands in neck; extreme pain in front of neck; shortness of breath/painful breathing; burning lips; burning nose; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in left arm on 06Mar2021 at 00:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune diseases and allergies to sulfa drugs. The patient took unspecified medication within two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Mar2021, the patient experienced red flushing cheeks at time of shot, swollen glands in neck, extreme pain in front of neck, shortness of breath, painful breathing, burning nose and lips. The adverse events resulted in a doctor or other healthcare professional office or clinic visit, and an emergency room or a department or urgent care. Therapeutic measures were taken as a result of the reported events and included treatment with BENADRYL and ant-inflammatory medications. The clinical outcome of the event red flushing cheeks at time of shot, swollen glands in neck, extreme pain in front of neck, shortness of breath, painful breathing, burning nose and lips was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
28 2021-07-17 mouth tingling Tingling lips; Tingling tongue; This is a spontaneous report from a contactable consumer, the patien... Read more
Tingling lips; Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) via an unspecified route of administration in the arm left on 30Mar2021 at 14:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive other medications within two weeks of vaccination. The patient had no allergies to food, drug or any other medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 16:00, the patient experienced tingling lips and tingling tongue. No therapeutic measures were taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tingling lips and tingling tongue was unknown. No follow-up attempts are needed. No further information is expected.
28 2021-07-18 ear discomfort, oropharyngeal discomfort, visual impairment, sensitivity to light Briefly after taking the first dose, I experienced left arm pain, which traveled to my fingertips, s... Read more
Briefly after taking the first dose, I experienced left arm pain, which traveled to my fingertips, shoulder, and to my chest area. After a few minutes, the pain went away. Two hours later, my head was hurting badly. A week later, I got chills, fatigue, dizziness, throat issues, my ears felt clogged, my nose was stuffy, and felt pulses in my knees and head. My body felt like it was fighting an infection. I felt very cold. Dizziness has not gone away, like when I get up from my seat. I have sinus issues as well. It feels like there is mucus in my throat all the time. My vision has also changed and sometimes things are too bright for my eyes.
28 2021-07-19 vision blurred Vertigo/room spinning; Blurry vision; General "fuzzy" head feeling; Headache going from back of head... Read more
Vertigo/room spinning; Blurry vision; General "fuzzy" head feeling; Headache going from back of head (left side) to the front.; Had a small rash that has since turned into the bruise; Had a small rash that has since turned into the bruise; Bruised knot at injection site still hasn't cleared; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0196) via an unspecified route of administration, in the left arm on 01Jul2021 (at the age of 28-years-old) as dose 1, single for COVID-19 immunization at pharmacy or drug store. The patient medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication within 2 weeks of vaccination included ESTRADIOL, 0.5mg once daily taken for an unspecified indication, start and stop date were not reported. Allergies to medications, food, or other products included dilaudid and lortab. Prior to vaccination patient was diagnosed with COVID-19 and did not received any other vaccines within 4 weeks. Since the vaccination, the patient had not been tested for COVID-19. On 01Jul2021, the patient experienced headache going from back of head (left side) to the front started within an hour of receiving the vaccine and hadn't stopped since, and Still ongoing; and also had Bruised knot at injection site still hadn't cleared and had a small rash that has since turned into the bruise. On 03Jul2021, on day 3 after vaccine patient had Vertigo including blurry vision, room spinning, and general fuzzy head feeling started and lasted until day 7. The reporter assessed the events as non-serious The patient did not receive any treatment for the event. Outcome of the events vertigo, blurry vision and general fuzzy head feeling was recovered on 07Jul2021 and outcome of other events was not recovered.
28 2021-07-20 ringing in ears Tinnitus in both ears onset approximately two hours after vaccination. Treated with 30mg prednisone ... Read more
Tinnitus in both ears onset approximately two hours after vaccination. Treated with 30mg prednisone for 10 days and symptoms did not resolve.
28 2021-07-26 blindness Patient came in nervous, before needle was removed from arm patient stated didn't feel good. Told to... Read more
Patient came in nervous, before needle was removed from arm patient stated didn't feel good. Told to sit 15 min. After 1 minute patient claimed loss of vision, dizzy, "not feel good" full body sweat. Asked to call EMT. Called EMT. Patient stated feeling better. Once EMT arrived, patient "not feel good"
28 2021-07-27 oropharyngeal discomfort elevated heart rate-in the range of 90-170 while just sitting/not engaging in activity; sore throat ... Read more
elevated heart rate-in the range of 90-170 while just sitting/not engaging in activity; sore throat with discomfort; sore throat with discomfort; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 28-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Mar2021 08:15 (at the age of 28-year-old) as single dose for covid-19 immunisation. COVID-19 vaccine was administered at Public Health Clinic/Administration facility. Medical history included drug hypersensitivity to penicillin, amoxicillin. Concomitant medications included ethinylestradiol, norgestimate (TRI-LO-SPRINTEC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, the patient experienced elevated heart rate-in the range of 90-170 while just sitting/not engaging in activity, sore throat with discomfort. The patient underwent lab tests and procedures which included heart rate: elevated in the range of 90-170 on 18Mar2021, normal range of inactivity 65-75. No treatment was given for the events. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
29 2020-12-31 smell distorsion, taste disorder, loss of smell Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches an... Read more
Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches and skin burned, 12/25 no taste or smell with chills body aches diarrhea skin burned and brain fog, 12/26 positive rapid covid test and symptoms continue
29 2021-01-01 sensitivity to light States she started feeling a bit of a headache after leaving the observation area, and by the time s... Read more
States she started feeling a bit of a headache after leaving the observation area, and by the time she got to her office in the same center, she had light sensitivity. Has not taken any medications no known allergies. Headache described as pulsating located in the front of her head. States relief when eyes are closed.
29 2021-01-02 painful gums, burning mouth syndrome 12 hours after first dose, had extremely painful and swollen R lymph cervical node and fatigue. Cont... Read more
12 hours after first dose, had extremely painful and swollen R lymph cervical node and fatigue. Continued for three days. On 12/25 awoke with painful gums, fevers of 102.1, chills in addition to symptoms. 12/26 had sore throat and worsening sores on tongue. Went to urgent care that morning, was tested for Covid, strep, influenza, RSV. All negative. Had overwhelming fatigue. 12/27 worsening tongue sores and thrush, had another appointment where given nystatin. At this appointment was diagnosed with an immune over response to the COVID-19 vaccine. The thrush still was not improving and extremely painful. Was started on Fluconazole for 14 days after another appointment on 12/29. No history of thrush, have good oral hygiene and follow all recommendations to prevent thrush with my inhaler. I lost 12 pounds due to the thrush and the extreme discomfort. Fever went away 8 days after vaccine dose, still have lingering thrush symptoms and R lymph node slightly enlarged.
29 2021-01-03 extreme sound sensitivity, sensitivity to light developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she de... Read more
developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she developed significant loss of mental clarity (brain fog); On 18Dec in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the the touch. This lasted about a total of 36 hours and progressively improve; brain fog; retroorbital headache/intermittent mild tension type frontal headache; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received first dose BNT162B2 (lot number EH9899), via an unspecified route of administration on 17Dec2020 12:00 at 29 years old at single dose at Left arm for COVID-19 immunization. Medical history included Mirena IUD, personal and family history of retinal migraines (without headache). The concomitant medications were magnesium citrate, melatonin, ademetionine (SAME) and fish oil. On 18Dec2020 in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the touch. This lasted about a total of 36 hours and progressively improved. There was no swelling, redness, or other local symptoms. In the afternoon on 18Dec2020, she developed significant loss of mental clarity (brain fog) while at work. In the evening on 18Dec2020, developed mild retroorbital headache (this was actually the first headache of my life). All day 19Dec2020 and about half the day of 20Dec2020 developed a migraine (also the first of my life), experienced as retroorbital pounding headache, sensitivity to light and sound in 19Dec2020, nausea without vomiting in 19Dec2020, and loss of mental clarity. She had intermittent mild tension type frontal headache on 20Dec2020 PM with all other symptoms resolved, all symptoms resolved by 21Dec2020 AM. The patient used naproxen 440 mg and Tylenol 1000 mg on 19Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not Allergic to medications, food, or other products. The outcome of the events was recovered on 21Dec2020. The information on the batch number has been requested.; Sender's Comments: Based on information available, the reported loss of mental clarity together with other events was likely related to the first dose BNT162B2 due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-01-04 loss of taste, loss of smell All of a sudden I did not have any taste or smell; All of a sudden I did not have any taste or smell... Read more
All of a sudden I did not have any taste or smell; All of a sudden I did not have any taste or smell; Tested positive; Tested positive; This is a spontaneous report from a contactable nurse reported for herself. A 29-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, batch/lot EH9899), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. Medical history included seasonal allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient was taking a multivitamin a day. The patient experienced typical symptoms no taste, smell on 22Dec2020, Slight tingling, body aches, chills, all the other symptoms for Covid and now positive for Covid in Dec2020. Outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for Covid based on the known safety profile.
29 2021-01-04 taste impairment Mild nausea (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10 minutes after in... Read more
Mild nausea (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10 minutes after injection. Muscle soreness at injection site beginning in the evening.
29 2021-01-04 ear swelling Woke up at 12:40 in the morning and was covered in hives and my face and ears were swollen
29 2021-01-04 mouth numbness, mouth tingling Numbness and tingling around mouth
29 2021-01-04 visual impairment Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness,... Read more
Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness, and verbalized feelings of being cold along with a very flushed appearance. Skin was slightly moist and very warm to touch. Complained she felt the same as when she was diagnosed with the coronavirus infection in March of 2020. Patient continued to experience ongoing weakness in all extremities, dizziness followed by complaints of some changes in her sense of the light with her eyes closed. Shortly thereafter patient began complaining of her heart "speeding" up. Medic arrived and transported patient to the local emergency room. On 1-2-2021 patient provided additional information including that later on the evening of the adverse event the arm where the injection was given became painful and itchy. Patient stated the pain and itching extended into Friday 1-1-2021 and then on into Saturday, 1-2-2021 she developed a sore throat, and some difficulty swallowing (described it as feeling something "stuck" in her throat) along with hoarseness. The patient also verbalized she remained weak, with a very sore arm and some small blisters which had formed on the same arm as where the injection had been given. A couple of the blisters the patient described where on the thumb of her hand as well her arm.
29 2021-01-06 extreme sound sensitivity, ear pain, sensitivity to light Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobi... Read more
Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobility/lessened neck pain but still limited mobility; Scalp tenderness and sensitivity; Significant migraines/debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness); Sharp pains in neck/Neck pain; Sharp pains in neck, ear, head pain (similar to an ear infection pain); head pain/sharp pains in lower head/covers whole head, pulsating, sharp pain/Increase in headaches but no longer centralized to back of head/ headaches induced by allergies; Nausea; Neck stiffness; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, via an unspecified route of administration in the right arm on 22Dec2020 07:30 at a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received vaccine in Tuesday (22Dec2020). The following Sunday (27Dec2020) at 12:00, she had nausea and neck stiffness. On Monday (28Dec2020), she had sharp pains in neck, ear, head pain (similar to an ear infection pain), and nausea. She used teledmed appt and got antibiotics (unspecified). On Tuesday (29Dec2020), she had significant migraines, limited neck mobility, sharp pains in neck and lower head, scalp tenderness and sensitivity which felt like whiplash when she moved her head w/ her head feeling "swimmy". She tried to see urgent care but was to go to ER. On Wednesday (30Dec2020), there was lessened neck pain but still limited mobility, increased in headaches but no longer centralized to back of head. She went to ER and they said that she had headaches induced by allergies. She mentioned that she never had migraines or allergies in her life. They also reported no ear infection. She did complete CT Scan with no concerning results on 30Dec2020. On Thursday (31Dec2020) & Friday, she no longer has neck pain but with continued nausea, joint pain, debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness). The events were reported as non-serious. The treatment received for the adverse events included fluids, pain & nausea meds. The patient was not diagnosed with Covid prior to vaccination. She was tested for covid post vaccination on 30Dec2020 through a nasal swab with negative result. The outcome of the events neck stiffness, ear pain, scalp tenderness and sensitivity, and 'Headaches induced by allergies' was unknown; while neck pain was recovered on 31Dec2020. The outcome of the events 'significant migraines/debilitating migraines', nausea, limited neck mobility, head pain/Headache, joint pain, loss of balance, and increased drowsiness was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event migraine cannot be excluded based on a compatible temporal relation between vaccination and onset of event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
29 2021-01-07 oropharyngeal discomfort strange feeling in my throat; Shaking; I felt like a fever was coming on/temp of 102; fatigue; extre... Read more
strange feeling in my throat; Shaking; I felt like a fever was coming on/temp of 102; fatigue; extremely sore arm; This is a spontaneous report from a contactable nurse, who is also the patient. This 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) via an unspecified route of administration in the left arm on 17Dec2020 at 09:00 at single dose for COVID-19 immunisation. Vaccination facility type: workplace clinic. The patient did not receive other vaccines in four weeks. Relevant medical history included asthma, hypothyroidism, seasonal allergy, allergy to pine nuts and almonds and past drug history included allergy to levofloxacin (LEVAQUIN). Concomitant medications included ethinylestradiol/norethisterone acetate (LOESTRIN), levothyroxine sodium (SYNTHROID), fluticasone furoate (VERAMYST), levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). On 17Dec2020, within a few minutes of receiving the vaccine, the patient noticed a strange feeling in her throat. The patient stated that it was difficult to describe, but only lasted a minute or so. That night (17Dec2020), as she was getting ready for bed, she felt like a fever was coming on, but she checked her temperature and it was 97.6 (her normal temperature). She woke up around midnight shaking, with a temperature of 102. She took ibuprofen and it came down to 100.8 before she fell back asleep. In the morning, her temperature was down to 98.5 and she did not experience any additional fevers. The only other symptoms she experienced were fatigue and an extremely sore arm. These lasted about two days. The patient recovered from the events strange feeling in her throat on 17Dec2020 and she recovered from the fever on 18Dec2020; the patient recovered from the other events in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was tested for COVID-19 with a nasal swab on 31Dec2020 which was negative.
29 2021-01-07 mouth tingling, feeling of choking 25 minutes after injection numbness of throat and tingling/prickling at back of tongue. Another 10 m... Read more
25 minutes after injection numbness of throat and tingling/prickling at back of tongue. Another 10 minutes later entire tongue tingling/prickling. Another 5 minutes lips began tingling/prickling. Epi-pen administered by military staff present for vaccination. Taken to ER and received a dose of Benadryl and prednisone.
29 2021-01-09 mouth numbness I got palpitations and tongue numbness 5-7 mins after receiving the IM injection. No rash/wheezing/h... Read more
I got palpitations and tongue numbness 5-7 mins after receiving the IM injection. No rash/wheezing/hypotension/angioedema. Got treated like anaphylaxis with epinephrine, decadron, benadryl, pepcid
29 2021-01-12 dry throat I am having chills since last night; Shortness and breathlessness last night; throat is super dry; d... Read more
I am having chills since last night; Shortness and breathlessness last night; throat is super dry; don't have too much pain in my left arm right where I got the vaccine; Left clavicle that is swollen and painful to touch; Left clavicle that is swollen and painful to touch; Little bit fever; This is a spontaneous report from a contactable consumer reported for herself. A 29-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiry date: Apr2021), via an unspecified route of administration in left arm on 05Jan2021 at single dose to get vaccinated to prevent COVID. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and hadn't taken Vitamins yesterday or day before. The patient got yesterday on 05Jan2021 the vaccine and thought that it was a side effect which she didn't have with the first vaccine. She had been having chills since last night 05Jan2021 and little bit of fever in Jan2021. She didn't have too much pain in her left arm right where she got the vaccine but her left clavicle that was swollen and painful to touch in Jan2021. The patient felt like she had a little bit of shortness and breathlessness last night 05Jan2021 but she was fine, her throat was super dry in Jan2021. For lot number, she stated "It is E. I am not sure what the next one is. It might be like a 21284." The patient had taken only pain killers she took two pain killers before she went to bed she took two pain killers when she woke in the middle of night and in morning. For Lab work, she just started feeling like between 12. The outcome of the events was unknown. Information on the lot/batch number has been requested.
29 2021-01-12 taste impairment Developed a metallic taste in mouth four days after injection. Symptom was present for 48 hours befo... Read more
Developed a metallic taste in mouth four days after injection. Symptom was present for 48 hours before resolving for 24 hours, but then returned again for at least 48 hours (symptom currently present). 50% improved from yesterday.
29 2021-01-12 mouth tingling, loss of taste, loss of smell, mouth numbness Estimated due date: 03/17/2021 On the day of the vaccine during observation I had tingling in my mou... Read more
Estimated due date: 03/17/2021 On the day of the vaccine during observation I had tingling in my mouth, numbness in tongue and I just used my Benadryl and it eased the symptoms. But at night I started wheezing, had sweats and chills, did not check my temperature but I had pretty severe chills that night. In the morning I checked no fever, but still chills, severe cough and sore throat.. Headache and fatigue. All got worse more severe on Saturday and then I decided to go get tested for Covid on the Care Clinic. I had a known exposure to COVID before I got the vaccine around 01/04/21 - my husband who tested positive on the 6th) I tested positive. All symptoms continued (except the tingling on the mouth it stopped on the 8th) and I saw my OB-GYN on the 11th due to a low amniotic fluid - I had an ultrasound at the facility and was referred to MD and saw him on the 11th as well. Now I lost my sense of taste and smell. The chills have subsided a little bit and so the headache, but fatigue, congestion and cough are still there. I had increased intermittent shortness of breathe but could be the baby's position.
29 2021-01-13 dry throat, dry mouth Shooting chest pains, delirium, dry mouth/throat with mild difficulty swallowing, severe weakness, s... Read more
Shooting chest pains, delirium, dry mouth/throat with mild difficulty swallowing, severe weakness, severe fatigue, sweating.
29 2021-01-13 visual impairment Patient experienced light headedness, diaphoresis, stated "i could see black spots in my eyes," but ... Read more
Patient experienced light headedness, diaphoresis, stated "i could see black spots in my eyes," but did not loose consciousness. She stated that she may have not eaten enough for lunch and has a fast metabolism that may have contributed to her symptoms. Patient transported from hospital vaccine center to hospital ED for further evaluation.
29 2021-01-14 lip swelling Covid vaccine on 1/11/2021. Tested positive for covid 1/13/2021. Developed lip swelling, hand/feet s... Read more
Covid vaccine on 1/11/2021. Tested positive for covid 1/13/2021. Developed lip swelling, hand/feet swelling and itching on 1/14/2021. Improved with benadryl.
29 2021-01-15 swollen tongue Difficulty swallowing, 30 minutes after vaccine was administered. Enlarged tongue, difficulty talkin... Read more
Difficulty swallowing, 30 minutes after vaccine was administered. Enlarged tongue, difficulty talking. Episodes lasted less than 1 minute and occured 4-5 times over 2 hours. No difficulty breathing, HR was not elevated. BP, pulse ox and temperature were normal.
29 2021-01-16 taste impairment, feeling of choking 29yo female patient reports feeling her throat tingling and closing sensation in her throat with a m... Read more
29yo female patient reports feeling her throat tingling and closing sensation in her throat with a metallic taste and diaphoretic approximately 3 minutes after receiving vaccine. She did not report these sensations until about 15min after injection. EMS assist was immediately called and pt was brought into one of the patient rooms. She was given Epipen injection approx. 20min after injection and EMS arrived to transport patient down to ER within 1-2 minutes after Epipen administered. Patient was monitored in ER and recovered well
29 2021-01-17 taste disorder Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness a... Read more
Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness at injection site; tingling/numbness at injection site; shoulder stiffness; altered taste; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 08Jan2021 at 11:00AM at a single dose (dose number: 2) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced swelling at injection site, inflammation around injection site. No Known allergies (allergies to medications, food, or other products) and no other medical history. It was unknown if the patient was pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced headache, nausea, pain at the injection site, fever/chills, body ache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste - after 2nd dose. Events with start date on 08Jan2021 at 11:30 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.
29 2021-01-17 visual impairment Twelve hours after receiving vaccine patient began experiencing chills & body aches. The next morni... Read more
Twelve hours after receiving vaccine patient began experiencing chills & body aches. The next morning (24 hours post-vaccine) the patient had a very bad migraine, chills, and body aches. Upon standing felt nauseous & dizzy, then saw black dots and vision went black for several minutes and fell to floor. Relative called 911 and vision had returned by the time medics arrived. Vitals were normal, except for low blood pressure. She took Advil and felt better by the evening.
29 2021-01-18 loss of smell, loss of taste tested covid positive on nov 11 without symptoms(my husband also positive) and have gotten 2 negativ... Read more
tested covid positive on nov 11 without symptoms(my husband also positive) and have gotten 2 negative tests since, got the vaccine jan 6. then jan 16 tested covid positive with intense body aches, mild respiratory symptoms and no taste or smell
29 2021-01-18 eye swelling On January 15, I developed urticaria to my face and neck, with a faint papular rash on my forearms a... Read more
On January 15, I developed urticaria to my face and neck, with a faint papular rash on my forearms also. On Jan 16, I developed facial edema with continued rash which worsened throughout the day despite Benadryl. On Jan 17, the rash was improving, but the facial and neck edema had worsened to the extent that my eyes were nearly fully closed. I presented to the ED and received treatment for allergic reaction, including Epinephrine, steroids, and histamine blockers. I have no known allergies.
29 2021-01-18 mouth tingling, lip swelling Immediately after the vaccine administration, she felt tingling around her lips, swelling of the lip... Read more
Immediately after the vaccine administration, she felt tingling around her lips, swelling of the lips, slight facial and chest flushing. She was given Benadryl 25 mg PO and sent to the ED for further evaluation. In the ED she was given famotidine 20 mg IV push once, methylprednisolone 125 mg IV push once, and a bolus of NaCl 0.9% 1000 mL over 65 minutes. Patient was asymptomatic 3 hours after vaccination.
29 2021-01-19 mouth tingling P29 y/o f with no pmh, on OCP's, citrus allergy (contact dermatitis), non smoker, sent to ED with pa... Read more
P29 y/o f with no pmh, on OCP's, citrus allergy (contact dermatitis), non smoker, sent to ED with palpitations, sob approximately 5 mins after receiving COVID vaccine. Patient describes palpitations as heart beating fast also with tingling in her tongue. She was given epinephrine and symptoms improved, however restarted shortly after. She denies chest pain, rash, oral swelling, difficulty swallowing, coughing, nausea, vomiting, syncope. Treated with benadryl, dexamethasone, famotidine
29 2021-01-19 feeling of choking vaccine recipient complained of itching/tingling in her throat after receiving vaccine. states this... Read more
vaccine recipient complained of itching/tingling in her throat after receiving vaccine. states this is similar to other allergen/medication reactions she has had. treated with benadryl and observed in clinic.
29 2021-01-20 mouth tingling, mouth numbness Numbness and tingling of lips and teeth
29 2021-01-20 mouth tingling 5 minutes after receiving the second Pfizer COVID19 vaccine, it reportedly felt difficult to swallow... Read more
5 minutes after receiving the second Pfizer COVID19 vaccine, it reportedly felt difficult to swallow, tongue felt large. Epi Pen administered and IM Benadryl. She was then transported to ER. On route, felt throat irritation, sore and a little bit of itchiness all over but no hives. She was observed in ER x 4 hours and released.
29 2021-01-20 toothache Main reaction: very achy wisdom teeth area (pulled ~10 years ago), all other teeth fine, for ~ 10 da... Read more
Main reaction: very achy wisdom teeth area (pulled ~10 years ago), all other teeth fine, for ~ 10 days Also: headache and dizziness night of vaccine, sore arm ~2 days
29 2021-01-21 dry mouth Hypertensive (167/91), tachycardia HR of 126, flushing, dizzy, dry mouth, sweating. patient refused... Read more
Hypertensive (167/91), tachycardia HR of 126, flushing, dizzy, dry mouth, sweating. patient refused further care and her symptoms improved then left the waiting area at 2:55pm. Before leaving, her vitals were BP 133/69, HR 70 and SpO2 100% on room air.
29 2021-01-21 chewing disorder First Dose- I had a headache after the shot and tremors started that even and throughout the night.... Read more
First Dose- I had a headache after the shot and tremors started that even and throughout the night. No fevor. Arm very sore, going into neck. Second Dose- Felt find the night. Woke up that morning at 1am and with tremors and in a night sweat. Checked temp and it was only 96, but felt hot and was sweating. Woke up the next morning and my entire body, muscles and joints ached. My knuckles, ached, kept getting sharp pains in my knuckles. My jaw ached, difficulty eating. My entire body, my muscle ached, difficulty moving. I didn't get a headache till that evening. I also had severe heart burn that night, not sure if it was related, but I have never had heart burn that bad. The next morning when I woke up (5am) (now two days after my shot), again my joints hurts, I couldn't even stand. Its like my knees couldn't even support me and I had a massive headache. I went back to bed and woke around 9am, no longer had a headache, muscles still hurt. Around 11am, all of a sudden, muscles and joints felt fine. The only thing (day three) is my arm pit on my left side where i got the shot is bothering my extremely bad. I was able to put an ultrasound probe on my axilla area, and I have swollen lymph nodes in my axilla in the area that is very painful. I also have a dull pain in my elbow.
29 2021-01-21 mouth discomfort, mouth tingling Hand of arm that vaccination was administered in began hurting, tongue tingling, & mouth feeling wie... Read more
Hand of arm that vaccination was administered in began hurting, tongue tingling, & mouth feeling wierd, light headache
29 2021-01-22 swelling of eyelid Adverse events: diarrhea around midnight, swollen eyelid developed overnight. Treatment: Diphenhydr... Read more
Adverse events: diarrhea around midnight, swollen eyelid developed overnight. Treatment: Diphenhydramine HCl 50mg around 8:00 am.
29 2021-01-23 pupils dilated -dilated eyes around 8 pm day of injection -extreme soreness in left arm day of injection -extreme ... Read more
-dilated eyes around 8 pm day of injection -extreme soreness in left arm day of injection -extreme body aches, chills, and sweats day of injection -insomnia that lasted from day of injection to early morning the next day. This was not anxiety related. -Frequent burping the night/overnight after getting injection -feeling of being hungover the day after the injection but this could be due to sleep deprivation from the insomnia.
29 2021-01-24 lip swelling Mild Shortness of breath for about 24hrs. Swollen lip from about 4:15pm into next morning until abou... Read more
Mild Shortness of breath for about 24hrs. Swollen lip from about 4:15pm into next morning until about 8:00 am. Sore throat for about 24 hrs. All treated with Benadryl from home.
29 2021-01-24 eye discomfort Severe injection site pain that began around 2 hours and went into the evening, severe in the evenin... Read more
Severe injection site pain that began around 2 hours and went into the evening, severe in the evening and night. Light soreness continued over the next day. 3 hours after receiving the 2nd vaccine, nausea, loss of appetite and general 'unwell' feeling began. Nausea, fatigue, loss of appetite, headache continued the rest of the first day. Symptoms impacted ability to work, went home early from work. Day 2: splitting headache, migraine, sinus pressure, joint pain which began in hips then spread to elbows, ankles, knees; muscle pain began in left calf then spread to shin. Injection site soreness was not severely painful any longer, mild pain. Loss of appetite continued. Nausea decreased, and no longer present by afternoon of day 2. Fatigue, increased sleep, sinus pressure in eyes, and cold chills persisted. Day 3: Migraine was present still upon waking and continued for whole day; loss of appetite remained but improved by late afternoon on day 3. Joint and muscle pain continued for duration of day 3. Fatigue continued. Increased need for sleep most noticeable today. For the first time, ibuprofen was taken for symptoms after receiving the vaccine almost 50 hour prior. Day 4: was able to return to work for the first time. Headache continued throughout day, nausea in the evening. Day 5: Headache continued but went away. Day 6 and Day 7, mild headache.
29 2021-01-24 toothache, mouth pain Dose 1 received 12/23/20 - had mild symptoms of fatigue and headache on 12/24/20. Dose 2 received 1/... Read more
Dose 1 received 12/23/20 - had mild symptoms of fatigue and headache on 12/24/20. Dose 2 received 1/14/21. Initial symptoms of mild/dull dental pain started on 1/19/20. on 1/21/21 and 1/22/21 started getting EXTREME right-sided oral/facial nerve pain/spasms that migrated to head that occurred intermittently every 30-60 min and lasted 2-5 min at a time in the evening. Saw dentist on 1/22/21 to check for issues with teeth, no dental issues were found on exam and on xray. Symptoms similar to trigeminal neuralgia/ bells palsy. Called Teledoc on 1/22 who suspected bell's palsy and prescribed prednisone 50 mg po qday x 5. Nerve pain attacks went always after first dose of prednisone. Currently still left with mild dull right-sided pain.
29 2021-01-24 vision blurred, double vision I received the COVID Vaccine yesterday (1/24/21) around 12:10pm. I experienced no effects while wait... Read more
I received the COVID Vaccine yesterday (1/24/21) around 12:10pm. I experienced no effects while waiting the allotted 30 minutes. The next morning, January 25th 2021, I started to experience arm soreness and blurry vision. The blurry vision is worse in my left eye. My vision has not improved after waking up, taking a shower and putting saline drops in both eyes. The best way to describe the sensation is hazy, blurry and sometimes double vision.
29 2021-01-26 ear swelling 1/14 Thursday 8am received vaccine 10am nauseous 11am soreness starts 12pm fatigue 6pm soreness heig... Read more
1/14 Thursday 8am received vaccine 10am nauseous 11am soreness starts 12pm fatigue 6pm soreness heightens, slight chills, more fatigue 7pm ear itch both sides, all ear involved even lobe and red 9pm soreness, chills, arm pain 1/15 Friday 7:30am nausea, dizziness, sinus pressure, headache, arm pain 1pm extreme fatigue, sleep for afternoon, arm pain 4pm headache intensify, arm pain 6pm both ear swelling, warmth, extreme itch 9pm lingering headache, arm pain improves 1/16 Saturday 7am ear itch and rash spread to back of neck 12pm telehealth - recommended benadryl, Rx prednisone Benadryl ineffective, rash remains 8pm- itch inside ears, red scaly ears, hot after washing, extremely scaly 1/17 Sunday 6 pills of methyl prednisone Hives moved to back of neck following the back of ear 1/18 Monday 6pills prednisone inside ear itch, ear lobes itch, skin very flaky 1/19 Tuesday Go to urgent care 6pills prednisone 1/21 Thursday Rash spreads to collarbone Go to TMC Dermatology prednisone continued 1/24 Sunday Stopped steroid under recommendation of MD Huge flare up around neck, chest, back and down to lower body Itch continues to night, lack of sleep 1/27 Wednesday Placed back on steroid (16 day course) Rash remains, itch subsided Decision to not take second dose
29 2021-01-26 oral mucosal blistering oral blisters
29 2021-01-26 mouth tingling Pt received vaccine @1726 and 5 minutes later she developed tingling to her upper and lower lips. As... Read more
Pt received vaccine @1726 and 5 minutes later she developed tingling to her upper and lower lips. Assessment was normal and at 1757 her symptoms completely resolved and she was released to home
29 2021-01-27 lip swelling Within 5 minutes of receiving Covid Vaccine (Pfizer ), second dose..... Employee complains of diffic... Read more
Within 5 minutes of receiving Covid Vaccine (Pfizer ), second dose..... Employee complains of difficulty breathing, warm, sweaty, left arm pain, lips swelling, tachycardia (p=140-100). Team called and sent to ER.
29 2021-01-27 visual impairment Migraine started 2.5 hours after receiving shot (2nd dose). Intense migraine with nausea, hand and f... Read more
Migraine started 2.5 hours after receiving shot (2nd dose). Intense migraine with nausea, hand and facial tingling/ numbness, seeing spots. Went away at just about 24 hours after it started. Got the chills just before it went away, no fever. Skin sensitivity and fever set in around 26 hours in - 102. Heart rate jumped from 130-170. Improved to about 150 with Tylenol and ALOT of fluids as fever improved, remained high until fever was gone around noon the next day. Hip pain, neck pain and back pain throughout. Hip pain first 24 hours. Back pain following that.
29 2021-01-28 eye pain right eye pain - started 2 days after first vaccine, foreign body sensation, urgent care visit to r/... Read more
right eye pain - started 2 days after first vaccine, foreign body sensation, urgent care visit to r/o corneal abrasian (negative), using topical eye drops, advil - self resolved after 5 days similar symptoms after 2nd dose, started 24hours after second dose, resolved within 48 hours of second dose
29 2021-01-28 eye itchiness Itchy eyes/ears - 2 Benadryl were given (50mg).
29 2021-01-28 swollen tongue, lip swelling raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneou... Read more
raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration on the left arm, on 14Jan2021 at 05:15, at a single dose for Covid-19 immunization. Medical history included asthma and uses an inhaler, glaucoma, nonsustained ventricular tachycardia for which she takes no medication. When she was a baby she had a reaction to the pertussis vaccine, she thought it was just a rash. Concomitant medications included topiramate (TOPAMAX) and bupropion hydrochloride (WELLBUTRIN). On 14Jan2021, the patient had a reaction after getting the vaccine. She reported that she had lip and tongue swelling. On the day of the report she still has the lip swelling. On 15Jan2021, the patient also had a raspy throat, red ears, a temperature, and headache. The center where she got the vaccine gave her diphenhydramine hcl (BENADRYL) through injection and the swelling went down. She noted she can breath, that has been complete fine. She explained that the lip and tongue swelling had gone completely down last night after the diphenhydramine hcl, but the lip swelling has come back as she has not taken any diphenhydramine hcl yet at the time of the report. She plans on taking some soon. The outcome of the event of tongue swelling was recovered on 14Jan2021 and outcome of other events was not recovered.
29 2021-01-29 eye movement disorder "Pfizer-BioNTech COVID-19 Vaccine EUA" I received my 2nd dose of the Pfizer COVID-19 vaccine on Jan.... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA" I received my 2nd dose of the Pfizer COVID-19 vaccine on Jan. 20th, 2021. On Jan. 21st, 2021, I woke up feeling feverish. I went to use the bathroom, and after washing my hands I walked towards the bathroom door and felt light-headed and dizzy. Suddenly, I passed out and hit my head and upper neck on the tile floor. My parents heard the sound of my fall and luckily rushed to the bathroom. They found me lying unconscious on the floor with my eyes rolled up for what felt like more than a minute. I regained consciousness on my own, and I drank water with a bit of sugar and salt mixed in. I felt too weak to get up and walk, and the back of my head and upper neck were in pain. I told my parents to call 911 as I wanted to make sure that there was no serious damage to my brain or neck area. I went to the local hospital in an ambulance. I was taken to the emergency room: Vitals were done and my temperature ranged from then was 99.5-101F and my heart rate was high- it stayed around 112 bpm for some time I was given 2 L of IV Saline Fluids EKG result: no clinical abnormalities CT head/neck/spine: negative 2 different types of COVID-19 tests: results were both negative Bloodwork: CBC/BMP/D-dimer: no clinical abnormalities Chest Xray: negative 2D- doppler ultrasound: negative Holter monitor: negative for irregular heart rhythm I was discharged the same day around 4:30pm
29 2021-01-29 swollen tongue Tongue and facial swelling.
29 2021-01-31 eye swelling, eye itchiness, dry eye Began with Dry, itchy eyes then eyes became swollen
29 2021-01-31 mouth ulceration Fever, Chills, severe Headache, fatigue, weakness, nausea, vomiting, back pain, mouth ulcers, UTI, b... Read more
Fever, Chills, severe Headache, fatigue, weakness, nausea, vomiting, back pain, mouth ulcers, UTI, body aches, muscle pain, dizziness, etc.
29 2021-02-01 ringing in ears, mouth numbness Patient stated she had a numb tongue and ringing in the ears
29 2021-02-02 swollen tongue HAd trembling, heart racing, chest tingling some difficulty swallowing and swelling of the tongue. ... Read more
HAd trembling, heart racing, chest tingling some difficulty swallowing and swelling of the tongue. She premedicated with benadryl.
29 2021-02-02 swollen tongue COVID-19 Vaccine Reaction Vaccine administered: Pfizer 1of2 1631, doing 30 minute observation for... Read more
COVID-19 Vaccine Reaction Vaccine administered: Pfizer 1of2 1631, doing 30 minute observation for hx of reaction to abx Patient reaction: Pt came to observation area requesting benadryl for c/o tongue and facial swelling reported by pt. Action taken: 50 mg benadryl given PO at1700 Outcome:1706-VS stable, Pt hypertensive 158/86, pt reports Hx of hypertension, HR initially elevated in 90's, but decreased to 70-75 after 15-20 minutes, no stridor or respiratory distress observed. 1725- HR 73, BP 139/96 1727 - pt released to contact a ride home, pt reporting feels good to leave observation area. . Doctor present and at bedside
29 2021-02-02 vision blurred Blurry Vision, headache,dizziness, armpit pain, increased heartrate ( 165) , high blood pressure ( 1... Read more
Blurry Vision, headache,dizziness, armpit pain, increased heartrate ( 165) , high blood pressure ( 195/110 ) leg pain, muscle aches
29 2021-02-03 eye twitching Eye twitching; This is a spontaneous report from a contactable Other HCP (patient). This 29-year-old... Read more
Eye twitching; This is a spontaneous report from a contactable Other HCP (patient). This 29-year-old female patient (no pregnant) received 1st dose of BNT162B2 Intramuscular on 07Jan2021 02:00 PM at single dose on Right arm for covid-19 immunization. Medical history was COVID prior vaccination. No other vaccine in four weeks. Concomitant drug was not reported. Patient experienced Eye twitching on 07Jan2021 04:00 PM. No treatment. Outcome of the event was Not Recovered. No COVID tested post vaccination. No follow-up attempts are possible; information about batch number cannot be obtained.
29 2021-02-03 oropharyngeal discomfort Abdominal pain, diarrhea, pain in joints, tiredness, nausea, pain in the chest, chills, nasal conges... Read more
Abdominal pain, diarrhea, pain in joints, tiredness, nausea, pain in the chest, chills, nasal congestion and discomfort in the throat.
29 2021-02-03 pain in jaw Coughing; Jaw pain; Fatigue the same day as vaccine; This is a spontaneous report from a non-contact... Read more
Coughing; Jaw pain; Fatigue the same day as vaccine; This is a spontaneous report from a non-contactable other healthcare professional (HCP; patient herself). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot/batch number and expiration date were unknown), intramuscularly on the right arm on 18Jan2021 at 10:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient's medical history was not reported; she had no allergies to medications, food, or other products. Concomitant medications included dexamethasone, bupropion, and hydroxyzine hydrochloride (HYDROXIZINE). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fatigue the same day as vaccine on 18Jan2021 at 13:00. Two days later, on 20Jan2021, the patient experienced coughing and jaw pain. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. The patient was recovering from all the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
29 2021-02-07 mouth swelling Mouth swelling; hives in mouth and lips; Body aches; joint pain; chills; This is a spontaneous repor... Read more
Mouth swelling; hives in mouth and lips; Body aches; joint pain; chills; This is a spontaneous report from a (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK4176), via an unspecified route of administration in left arm on 14Jan2021 11:45 at first single dose for COVID-19 immunization. Medical history included covid-19 (covid prior vaccination), known allergies: Penicillin, sulfa drugs. There were no concomitant medications in two weeks. No other vaccine in four weeks. The patient experienced body aches, joint pain and chills began about 16 hours after receiving vaccine (15Jan2021). Mouth swelling and hives in mouth and lips began 4 days after (18Jan2021 10:00 AM). AE resulted in doctor or other healthcare professional office/clinic visit. AE treatment included: prescribed steroids. Covid was not tested post vaccination. Outcome of the events was recovering. No follow up attempts are possible. No further information is expected.
29 2021-02-08 loss of smell, loss of taste, inability to speak On 2/5/21 patient received Pzifer COVID-19 dose #2 early afternoon at workplace clinic. On 2/9/21 pa... Read more
On 2/5/21 patient received Pzifer COVID-19 dose #2 early afternoon at workplace clinic. On 2/9/21 patient reported beginning 2/5/21 early evening she began having overall body rash and body ache that progressed over the next few days to sore/swollen throat, voice loss, nausea, intermittent fever, loss of taste and smell, headache, and diarrhea. Tested COVID-19 negative 2/9/21, still having symptoms. Stated has not seen her healthcare provider but will contact for care.
29 2021-02-08 oropharyngeal discomfort, eye swelling Approximately an hour after vaccine administration I developed a scratchy throat. Soon after I felt ... Read more
Approximately an hour after vaccine administration I developed a scratchy throat. Soon after I felt like my eyes were swollen, though not swollen visibly. I also had mild itching across my arms. These symptoms improved within 3-4 hours without medical intervention.
29 2021-02-09 dry mouth constant fluctuation of burning up; sweating profusely; having chills; headache; diarrhea; dryness o... Read more
constant fluctuation of burning up; sweating profusely; having chills; headache; diarrhea; dryness of mouth; runny nose; occasional coughing; dizziness; occasional fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 29-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from 21Jan2021 09:00 (at the age of 29-years-old) at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included spironolactone, sertraline and bupropion. Prior to vaccination the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 22Jan2021 11:00, the patient experienced constant fluctuation of burning up, sweating profusely, having chills, headache, diarrhea, dryness of mouth, runny nose, occasional coughing, dizziness and occasional fatigue. No treatment was received for the events. The events were reported as non-serious. The patient underwent lab tests and procedures which included Rapid Antigen: pending on 24Jan2021. Outcome of the constant fluctuation of burning up, sweating profusely, having chills, headache, diarrhea, dryness of mouth, runny nose, occasional coughing, dizziness and occasional fatigue was not recovered. Since the vaccination, the patient been tested for COVID-19.
29 2021-02-09 taste impairment Metallic taste in mouth; This is a spontaneous report from a contactable consumer (patient). A 29-ye... Read more
Metallic taste in mouth; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247, expiry date unknown) via an unspecified route of administration on 28Jan2021 11:45 AM in left arm at single dose for COVID-19 immunization. Medical history included acne and no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included adapalene (DIFFERIN, topical cream) cutaneous for acne. The patient experienced metallic taste in mouth on 28Jan2021 12:00 PM and no treatment was received. The outcome of the event was not recovered. The event was reported as non-serious and no results in death, life threatening, caused or prolonged hospitalization, disabling or incapacitating, congenital anomaly or birth defect involved.
29 2021-02-09 vision blurred, mouth swelling Adverse event: Blurred vision, numbness left side head to shoulder, vomiting, chills, shortness of b... Read more
Adverse event: Blurred vision, numbness left side head to shoulder, vomiting, chills, shortness of breath, severe headache, oral mycosis swelling Treatment: Benadryl Outcome: Sent to ER by facility MD, treated and observed at hospital for 1.5 hours released no negative outcome
29 2021-02-10 dry throat, ringing in ears Approximately 4 minutes after receiving my vaccine I felt warmth down injected arm. Approximately 20... Read more
Approximately 4 minutes after receiving my vaccine I felt warmth down injected arm. Approximately 20 minutes post injection, I experienced a drop in my blood pressure, heaviness in my legs (like walking through cement), and ringing in my ears. At approximately 12:30-12:45pm I experienced mental fog (I couldn't remember how to turn off my windshield wipers), increased heart rate, rapid onset of feelings of panic, minor shortness of breath, neck/clavicle tightness on side of injection, and sweating. Between approximately 1:30pm and 2:30pm I continued to have extreme sweating, as well as: increased pulse, fatigue, dry throat, muscle weakness/shakiness, brain fog, and headache. At approximately 3:30 I hit my knee on the bed frame and felt like the wind had been knocked out of me and immediately had a severe drop in blood pressure that felt similar to a vasovagal event. I called the vaccine clinic and my symptoms were noted and I was told to seek help if my symptoms worsened or I felt like I was going to pass out. My symptoms have not worsened but I am still experiencing extreme sweating along with shivering, shakiness, blood pressure changes with movement (orthostatic hypotension), and fatigue - time is currently 5:50pm
29 2021-02-10 eye swelling anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feelin... Read more
anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; in the evening arm swelled/swelling went down to size of pin hole; there was a welt at the vaccination site / there was still a little knot on arm; fever; night sweats; body rash/ rash beneath eyes; blister sores; swelling of eyes; arm was painful and is still; This is a spontaneous report from a contactable consumer. A 29-years-old female patient, a registered nurse, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number BK9231, in Hospital, via an unspecified route of administration in left arm on 04Jan2021 at 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of the vaccination. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC). The patient reported that 2 mins after the shot, her left arm felt heavy and was hard to move and, on 04Jan2021 at 14:15 she had tingling/dead feeling; in the evening arm swelled and there was a welt at the vaccination site. On an unknown date in Jan2021 she had fever at 102 °F for 48 hours and swelling went down to size of pin hole; her arm was painful and was still sore, there was still a little knot on arm. On 07Jan2021 she experienced an anxiety attack; 20 days after, in Jan2021 the patient experienced night sweats. She also experienced body rash and little blister sores on her body and both arms, swelling of eyes and rash beneath eyes. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered to the patients for the events. On 25Jan2021 the patient underwent COVID-19 test via Nasal Swab which showed negative results. The event "Fever" resolved after 48 hours, whereas the outcome of all the reported events was unknown at time of the report.
29 2021-02-10 tongue itchiness One hour after vaccine, her tongue and throat was itchy. She took Benadryl and it resolved.
29 2021-02-11 loss of taste, loss of smell I received the Pfizer vaccine through my employer, and shortly after I had an abrupt loss of taste ... Read more
I received the Pfizer vaccine through my employer, and shortly after I had an abrupt loss of taste and smell (with no other symptoms). The first round I received was on 12/21/20 (#EK5730), followed by another on 1/11/21 (#EL1284). That Sunday, 1/17/21, I suddenly noticed I lost my sense of taste while eating dinner. I didn't notice the loss of smell right away, but did notice it later in the evening. To my knowledge, I have never had covid. I immediately requested to get tested for covid that Monday, on 1/18/21 - 2 days later, the results came back negative. Because I've heard of false negatives being common, I requested to get another test, which my employer authorized a week later, on 1/25/21. The test came back negative for covid again, after 2-3 days. As a last ditch effort, I went to the urgent care on Tuesday, 2/2/21, to get some bloodwork done and some reassurance. All my bloodwork came back normal. They offered me another covid test and I was swabbed again - results came back negative, again. My sense of taste and smell still have not returned. I would say my sense of taste has been steadily at a 15-20%, with the sense of smell being even less. This entire time I have had absolutely no other symptoms - no coughing, no shortness of breath, no fever, or any other symptom.
29 2021-02-11 oropharyngeal discomfort Pt developed increased work of breathing about 10 min after injection. Used albuterol 8 times with l... Read more
Pt developed increased work of breathing about 10 min after injection. Used albuterol 8 times with little improvement. HR remained 74-88, BP122/73, 118/56. RR 40-50 O2 sat 99-100. Pt did not want EPI. Was given 50 mg of Benadryl without improvement. Pt denied CP, throat symptoms, nausea/vomiting, headache or dizziness. Monitored for 30 min in vaccine clinic without progression of symptoms. Pt declined emergency transport, so was taken via wheelchair to ER for further monitoring.
29 2021-02-12 pain in jaw Injection site pain, arm pain from shoulder to elbow in injection arm full body aches throat pain he... Read more
Injection site pain, arm pain from shoulder to elbow in injection arm full body aches throat pain headache/sinus pain jaw pain
29 2021-02-14 mouth tingling Patient almost immediately stated she felt "tingly" on her toung along with the feeling of her throa... Read more
Patient almost immediately stated she felt "tingly" on her toung along with the feeling of her throat swelling shut. Patient stated it felt much like it does when she has an allergic reaction to shellfish. 1 adult epinephrine pen was administered to patient intramuscular in thigh and patient was taken to hospital emergency department for workup and observation. In ED, symptoms had subsided, and patient reported feeling better. Patient was given IV diphenhydramine x one 25 mg dose (1751) and IV methylprednisolone x one 125 mg dose (1751). No additional doses of epinephrine were required.
29 2021-02-14 mouth tingling Tingly lips and throat. Red eyelids. Self-administered benadryl and all symptoms resolved after mo... Read more
Tingly lips and throat. Red eyelids. Self-administered benadryl and all symptoms resolved after monitoring for 1 hour.
29 2021-02-17 eye swelling Facial swelling, eye swelling, itching of the face
29 2021-02-17 ringing in ears hemifacial spasms on the right side of face; weird sound in the ear; pulsating in the neck; This is ... Read more
hemifacial spasms on the right side of face; weird sound in the ear; pulsating in the neck; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 29-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the left arm on 30Dec2020 10:00 (lot number and expiry date unknown) at single dose for Covid-19 immunization in a workplace clinic. Medical history included hidradenitis suppurativa. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included unspecified other medication. The patient received first dose of hepatitis vaccine in the left arm on 15Dec2020 (29 years old) for immunization which was within 4 weeks prior to the COVID vaccine. On 07Jan2021 07:15, the patient experienced hemifacial spasms on the right side of face. The right side of face tightens to the point her eye closes, mouth pulls up and cheeks pulls up as well along with a weird sound in the ear and pulsating in the neck. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included CT scan: unknown results in Jan2021. The patient has not been tested for COVID-19 since the vaccination. The patient received treatment of muscle relaxer, medrol dose pack. The outcome of the events was not recovered. The reporter considered the events serious as disabling/incapacitating but did not results in death, not life threatening, did not cause/prolong hospitalization, no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the hemifacial spasms and other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics including results of Head CT scan, EMG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-02-20 mouth itchiness Patient reported to COVID-19 Vaccine clinice on 02/21/2021 for first dose of Pfizer Covid-19 Vaccin... Read more
Patient reported to COVID-19 Vaccine clinice on 02/21/2021 for first dose of Pfizer Covid-19 Vaccine. Patient received first dose, and described a "tightness/itchiness" in her throat, radiating up her jaw. Patient was able to take benadryl by mouth at 2:50pm. Itchiness and tightness in throat did not subside, so emergency services were called around 3:00pm. Ambulance arrived a few minutes later and patient was take via ambulance for emergency medical serices. No epi-pen was administered as of time of departure from clinic.
29 2021-02-20 pain in jaw, lockjaw Right sided jaw pain and discomfort. I constantly feel like it's swollen and sometimes dislocated. I... Read more
Right sided jaw pain and discomfort. I constantly feel like it's swollen and sometimes dislocated. I feel like I have difficulty moving my jaw on the right side.
29 2021-02-21 ear pain Nausea, fever, chills, aches and pains, fatigue, headache, neck ache, ear pain, swollen lymph nodes,... Read more
Nausea, fever, chills, aches and pains, fatigue, headache, neck ache, ear pain, swollen lymph nodes, sore arm. These symptoms lasted about 2 days total.
29 2021-02-21 mouth numbness Bell's Palsy -loss of muscle movement in left side of face, numbness in tongue, pain in neck. Began ... Read more
Bell's Palsy -loss of muscle movement in left side of face, numbness in tongue, pain in neck. Began on 2/18 with numbness, woke 2/19 with no control of facial muscles Received steroids and antivirals, no improvements
29 2021-02-21 visual impairment, double vision Symptoms 01/24/2021- numbness, weakness, tingling bilateral legs. Lost inability to walk and bladder... Read more
Symptoms 01/24/2021- numbness, weakness, tingling bilateral legs. Lost inability to walk and bladder control Admitted to hospital 01/24/2021-1/26/21. Not diagnosed. Had 4 MRIS and a lumbar puncture 02/3/2021- was in ED at hospital due vision issues/double vision- discharged same day. Repeated 4 MRIS and blood work, and lumbar puncture. 02/09/2021- patient was seen at a neurologist, due to numbness in bilateral hands and arms. And was admitted to Medical Center until 02/13/2021. Ruled out MS, GB, repeated 4 MRIS and LP. Was sent home with home health and PT. Saw PCP 02/19/2021, Did paperwork for disability and removed from work until 04/30/2021. PCP ordered more blood work up to 35 tubes of blood done on 02/17/2021. Will not be ready until 14 days post draw. Patient is still complaining of tingling on bilateral hands and feet, and weakness. Mainly sensory nerves related symptoms.
29 2021-02-22 mouth numbness Approx 5 minutes after receiving the vaccine, client started c/o feeling hot, sweaty, Left side of t... Read more
Approx 5 minutes after receiving the vaccine, client started c/o feeling hot, sweaty, Left side of tongue numb and she had pressure on the left side of her head, her BP dropped and she felt weak. No medications given. She felt better after 10 minutes. She called her doctor and he gave her an epi pen and told her not to take the 2nd dose of Pfizer. She says she felt dizzy and weak for 3 weeks afterwards, but fine now.
29 2021-02-23 toothache, painful gums, teeth hypersensitivity, mouth numbness, chewing disorder Firs and Second dose done in left arm 2 days after second vaccine I had a fever and the top left of ... Read more
Firs and Second dose done in left arm 2 days after second vaccine I had a fever and the top left of my mouth and teeth have been numb and I can?t feel anything. It?s the top 3 to 3 teeth and my gums that feel as if I was getting numbed at the dentist. It still hasn?t gone away I can?t feel my lip and my teeth hurt to chew anything and are sensitive to cold and hot and throbbing. I went to the dentist and they said it was fine. So I?m here reporting it and now I will be going to my PCP. Thank you
29 2021-02-24 dry throat Dizziness, Lightheaded, Chills, the first time I had to stop because couldn't drive, I had spasm's a... Read more
Dizziness, Lightheaded, Chills, the first time I had to stop because couldn't drive, I had spasm's around the injection site, Generalized Numbing, the symptoms of the fisrt dose lasted one week. I don't like to take medicine and I had no choice but take Panadol every 4 hours and apply ice to treat the muscular pain. I went to emergency and was told that I had an urine infection (which is very rare on me), and was treated with antibiotics. With the second dose I took acetaminophen 500 mg befor the vaccine, that helped because the day of the shot I didn't have pain, but the numbness was like if I couldn't connect my body to the brain. Couldn't talk properly, sleep 2 hours during the day, is funny that I applied ice on the injection site (Me thinking) but the pain doesn't go away, when the ice melts I notice that I applied the ice on the wrong arm. That's what I mean when I talk about numbness. Fever of 39.8F and Chills even today . Some cough and dry throat (Dryness can be because I'm a teacher) and constant tiredness.
29 2021-02-24 mouth tingling Dizziness; tongue tingling.
29 2021-02-24 feeling of choking HIVES, ITCHY NECK, SWOLLEN LYMPH NODES, SCRATCHY THROAT, TINGLING IN THROAT
29 2021-02-25 ear swelling Patient felt nervous, difficulty breathing and complained about swelling in the back of the throat w... Read more
Patient felt nervous, difficulty breathing and complained about swelling in the back of the throat within 15 minutes of administration. Her face was red and heart rate was elevated to 120bpm with blood pressure of 140/90mmhg.
29 2021-02-25 swollen tongue 29 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first dose of the COVID 19 va... Read more
29 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience throat and chest tightness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress and tongue swelling. PMH includes anxiety. Takes lexapro 10 mg for this. She is currently 21 weeks pregnant. Feels baby moving. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 0857 BP: 126/68 Pulse: 93 SpO2: 100% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious (slightly). Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)
29 2021-02-27 vision blurred First dose: fatigue with left arm soreness Second dose: chills, whole body soreness and ache, low gr... Read more
First dose: fatigue with left arm soreness Second dose: chills, whole body soreness and ache, low grade fever and an ongoing blurry vision. I went to the ophthalmologist and the ocular ct showed right eye optic nerve is inflamed.
29 2021-03-01 mouth itchiness My mouth and tongue started itching; Skin broke out in a rash and became super itchy; Skin broke out... Read more
My mouth and tongue started itching; Skin broke out in a rash and became super itchy; Skin broke out in a rash and became super itchy; Have hives; This is a spontaneous report from a consumer reporting for herself. A 29-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # em9809) vaccine , via an unspecified route of administration in the left arm on 24Feb2021 14:30 at single dose for covid-19 immunisation . Medical history included asthma , attention deficit hyperactivity disorder , polycystic ovaries , sleep apnoea syndrome, arthralgia , the patient was allergic to Albuterol, Penicillin, Cephalosporin, Iodine, Bees, all types of fish, all types of shellfish, peanuts, all types of tree nuts. Concomitant medication included cefixime (FLEXERIL), acetylcarnitine hydrochloride (NEUROTIN ), naproxen (MOTRIN). The patient experienced my mouth and tongue started itching on 24Feb2021 14:30 with outcome of not recovered , skin broke out in a rash and became super itchy on 24Feb2021 14:30 with outcome of not recovered , have hives on 24Feb2021 14:30 with outcome of not recovered. The reported events were considered Life Threatening. The patient received Benadryl, and got epi on hand as treatment. Follow up information has been requested.
29 2021-03-02 taste disorder fever; chills; aches; headache; fatigue; loss of appetite; Dulled taste; patient received the first ... Read more
fever; chills; aches; headache; fatigue; loss of appetite; Dulled taste; patient received the first dose on 12Jan2021 and the second dose was on 29Jan2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: El9362; expiration date: unknown) at vaccination age of 29-year-old via an unspecified route of administration in the left arm on 29Jan2021 16:45 at a single dose for covid-19 immunization. Medical history included hypothyroidism, PCOS (polycystic ovarian syndrome) and penicillin allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included levothyroxine, metformin and vitamin nos (MULTIVITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: Ek4176) at vaccination age of 29-year-old via an unspecified route of administration in the left arm on 12Jan2021 16:45 at a single dose for covid-19 immunization but had lump on neck, sore arm, diarrhea starting day 3 through today and sore rib. The patient received the most recent COVID-19 vaccine in a hospital. It was reported that the patient received the first dose on 12Jan2021 and the second dose was on 29Jan2021. On an unspecified date after the second dose, the patient had fever, chills, aches, headache, fatigue, loss of appetite and dulled taste. It was unknown if the patient received treatment for the adverse events and events were considered as non-serious. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.
29 2021-03-03 swollen tongue, mouth tingling 9:50am, client approached nurse 5 minutes post-vaccination complaining of heaviness in her chest, an... Read more
9:50am, client approached nurse 5 minutes post-vaccination complaining of heaviness in her chest, and a swollen tongue. Client was escorted to our emergency area for assessment and observation. History of allergies to nuts, garlic, flax seed, and black pepper. Also history of asthma, and need for epi pens twice in the past. 9:56am pulse 100, O2 100%, BP 150/112, c/o tingling in lips, chest heaviness, and swollen tongue. 10am, Complaints of chest heaviness is worse, no shortness of breath, client is able to talk. 10:10, pulse 93, O2 100%, BP 162/110. Tourniquet placed above vaccine injection site. Medical Director contacted, advised to start with Benadryl based on history and high heart rate. As Benadryl was about to be administered, client increased complaints of chest heaviness, and not being able to swallow. Benadryl (50mg) and Epi (0.3) given at 10:19am. Benadryl was IM in right deltoid, Epi was given in right thigh. 911 called simultaneously. 10:25, O2 100%, pulse 109, reports breathing easier. 10:26 EMS arrived, client transported to local hospital.
29 2021-03-05 lip swelling Patient with prior hx of anaphylaxis - required 30 min wait, ~ 25 mins into wait time - reporting sl... Read more
Patient with prior hx of anaphylaxis - required 30 min wait, ~ 25 mins into wait time - reporting slight swelling of lips, sensation of itchy throat/tightening, appearance of hives on arms. Patient alert and oriented, breathing comfortably. Advised will take to ED dept for further evaluation - patient refusing wheelchair - ambulatory. Walked to ED dept with NP, report given to ED, registration completed.
29 2021-03-05 smell distorsion, taste disorder Taste and smell became disgusting; on day 1 of symptoms (2/27) everything that I tasted was a range ... Read more
Taste and smell became disgusting; on day 1 of symptoms (2/27) everything that I tasted was a range between stale and vomit-flavored. Bread and cheese were altered but 'okay' until day 5 of symptoms. Currently on day 7 of symptom and cannot tolerate smell or taste of anything, including water. Every single food item, anything with scent (like soap), water, even the heat from the stove smells/tastes like vomit. Went to clinic on 3/5/21 and tested negative for COVID-19 (Previously tested positive on Dec 10, 2020 so ensuring had not contracted again) and full blood count came back normal. Expect follow up call on Monday for MRI/CT scan. I have a terrible headache but I imagine it is from lack of food and water since there was no sign of illness at doctor appointment. Doctor indicated he wants to see results of brain scan before saying for sure related to vaccine, but since I have absolutely no other symptoms, he was puzzled.
29 2021-03-05 ringing in ears, deafness unilateral, ear discomfort 49 hours after I began to feel dizzy, my ears clogged and I felt generally bad. I was sent to a doct... Read more
49 hours after I began to feel dizzy, my ears clogged and I felt generally bad. I was sent to a doctor who sent me to a hearing test. My right ear got damaged and cannot hear below ~40-50 decibel on all frequencies. + I got tinnitus. The treatment I got is Prednisolone 60 mg daily for a week. 4 days, nothing changed so far
29 2021-03-06 swollen tongue, lip swelling Patient presented for her first covid vaccine today. She received the immunization in her right delt... Read more
Patient presented for her first covid vaccine today. She received the immunization in her right deltoid at 1703, was seated in the 15 minute observation area. After about 10 minutes, she reported feeling dizzy. RN alerted EMS who brought her for closer evaluation. While in EMS care, patient developed rash and hives on her neck and arms, swelling in her lips and tongue, shortness of breath with oxygen saturations in the 80's. EMS started a 20g Left antecubital IV, administered 50 mg benadryl IM, 125 mg solumedrol IV, placed patient on supplemental oxygen at 2L nasal canula. After medication administration, patient's rash and hives began to resolve and she was able to speak clearly after medication. Patient was transported to hospital via ambulance for further evaluation. VAERS documented.
29 2021-03-08 mouth tingling About an hour after my first dose, my tough felt strange almost like a burnt my tongue. Kind of a ra... Read more
About an hour after my first dose, my tough felt strange almost like a burnt my tongue. Kind of a raw sensitive feeling. It has almost 3 weeks now and my tongue still feels this way. I've gone to the doctor for blood tests, mris and they said everything is normal and to try to contact the CDC about my tongue as it seems like it is a reaction to the vaccine. I am supposed to get my 2nd dose on Thursday 3/9/2021 and I'm not sure if I should. I also want to know if this is a reaction that other people have had.
29 2021-03-10 tongue discomfort, oropharyngeal discomfort Hot flashes. Body is hot. Itchy skin. Scratchy throat. Fuzzy tongue.
29 2021-03-11 lip itchiness Patient was brought to me by nurse who was with patient in waiting area when she became anxious afte... Read more
Patient was brought to me by nurse who was with patient in waiting area when she became anxious after receiving Phizer COVID 19 vaccine. She was alert and oriented when I placed her in the sitting position on an exam table in the observation area. approximately 20 minutes later, she reported feeling itchiness in nose and lips. There was no swelling, redness noted. There was no rash, SOB, difficulty swallowing. She has taken Benadryl for similar symptoms in the past and requested she be given some. She was given Benadryl 50mg PO. VSS through out. Symptoms resolved over next 20 minutes. She was asymptomatic at 1210 and was discharged with sister to drive home.
29 2021-03-14 eye pain, mouth tingling, eye discomfort During the first fifteen minutes after receiving the vaccine, the right side of my face started ting... Read more
During the first fifteen minutes after receiving the vaccine, the right side of my face started tingling and became numb. The left side of my face was not affected and there was no respiratory involvement. In the following few hours, my right eye had transient pain and my cheek felt swollen. The next day, I had chills, arm soreness, mild headache at times, and while my facial symptoms were still present, they had improved. The second day I only had mild numbness and tingling on my face with some lip tingling. Day three, four, and five I had slight numbness of the right side of my face and tingling lips, no further symptoms. As of day 6, I have slight eye pressure around my right eye and mild lip tingling.
29 2021-03-14 toothache Persistent toothache (this happened to my brother after the 2nd dose as well) Chills Body aches Naus... Read more
Persistent toothache (this happened to my brother after the 2nd dose as well) Chills Body aches Nausea
29 2021-03-15 deafness unilateral Could not hear out of left ear for three days after vaccine.
29 2021-03-15 mouth numbness, tongue itchiness, mouth itchiness, ear itchiness Immediately following vaccination, started having itchy tongue, ears and mouth. Rash emerged on lef... Read more
Immediately following vaccination, started having itchy tongue, ears and mouth. Rash emerged on left chest and shoulder with muscle pain. Left arm became numb, rash at injections site, migraine, numb lips and mouth. Persisted and progressed to vomiting and diarrhea, tachycardia and tachypnea. On 1/14, petechiae around both eyes, widespread muscle and joint pain, tachycardia and tachypnea persist, unable to lift left arm, itchy face, nose and throat. 1/15 Tachycardia persists, migraine, diarrhea, sudden onset vaginal bleeding. 1/16 elevated blood pressure, tachycardia and tachypnea, found unresponsive in bed by my husband and taken to the emergency room.
29 2021-03-15 swelling of eyelid, swollen tongue Pt. received first dose Pfizer COVID vaccine at 1415 and shortly developed throat itching, swollen t... Read more
Pt. received first dose Pfizer COVID vaccine at 1415 and shortly developed throat itching, swollen tongue, and swollen left lower eyelid. Baseline VS at 1418 was BP 126/82, RR 16, HR 122, O2sats 95% on RA. States throat felt tighter and epipen was administered to left thigh at 1419. She was examined Lungs CTA, no stridor, CV RRR and did not appear to be in distress with breathing. She was placed on oxygen at 2 liters. Code blue called at 1427. VS-BP 128/73, RR 18 HR 132 O2sats 99% on 2L post-epipen administration. States she felt better after epipen was administered and 2 puffs albuterol. Transported to local ER and discharged same evening.
29 2021-03-15 ringing in ears, hearing loss Experienced ringing in my right ear which turned into ?pulsating? noise in sync with heart beat. My ... Read more
Experienced ringing in my right ear which turned into ?pulsating? noise in sync with heart beat. My PCP recommended taking an allergy pill 1x/day and OTC allergy nasal spray 2x/day for one week. Symptoms persisted and I was referred to see an ENT. Completed a hearing test which showed diminished sense of hearing in my right ear but within normal limits. ENT recommended to monitor symptoms and to get an MRI if symptoms persist or worsen.
29 2021-03-16 lip swelling, swollen tongue " Heart rate went up and my lips, tongue and throat started swelling"" I took 3 Benadryl and had t... Read more
" Heart rate went up and my lips, tongue and throat started swelling"" I took 3 Benadryl and had taken Allegra that morning. It seemed to work and the swelling went down. Bad back pain, arm pain headache, general muscle aches, fatigue and my grip strength is very weak"
29 2021-03-17 mouth tingling c/o tinging to face. 25 mg oral benaryl given. Pt reported feeling better. 0920 co lips tingli... Read more
c/o tinging to face. 25 mg oral benaryl given. Pt reported feeling better. 0920 co lips tingling. 25 mg Benadryl given.
29 2021-03-17 swollen tongue Patient returned to vaccine center about two hours after first dose Pfizer COVID vaccination. Patien... Read more
Patient returned to vaccine center about two hours after first dose Pfizer COVID vaccination. Patient reported to have swelling to neck and face/jaw. Post vaccination nurse who had seen patient earlier noted mild swelling to neck, jaw and tongue. Airway clear, vital signs 131/98, 101bpm, saturation 97%, RR 16, awake alert, patient speaking full sentences, handling saliva, tolerating PO liquids. Nurse and pharmacist at bedside. EMS called to evaluate. EMS evaluated and transported to the Emergency Room. Patient reported to have a history of similar symptoms intermittently due to a chronic rheumatologic condition.
29 2021-03-19 loss of taste, loss of smell On Tuesday the injection site developed hives. On Wednesday I felt very sick. On Saturday I lost all... Read more
On Tuesday the injection site developed hives. On Wednesday I felt very sick. On Saturday I lost all sense of taste and smell.
29 2021-03-19 swollen tongue Patient received vaccine and was waiting for 30 minutes in the observation area due to history of al... Read more
Patient received vaccine and was waiting for 30 minutes in the observation area due to history of allergic reactions. At 20-minutes post-vaccination, patient experienced hives and swelling in her tongue. Patient reported to EMS that it felt like previous allergic reactions. EMS assessed VS. BP 151/101, HR 98, O2 sat 97%. EMS administered 1 Epi pen into the R thigh. Patient had a rapid resolution of symptoms. EMS recommended transport to ER, patient agreed. Transported to EMS. Post epi vitals were 150/69, HR 80, O2 Sat 97%.
29 2021-03-20 ear pain, mouth tingling Lip and facial tingling, R ear pain started right after vaccination was given. Benign exam, unremark... Read more
Lip and facial tingling, R ear pain started right after vaccination was given. Benign exam, unremarkable vitals. Sensation intact. Suspected anxiety, pt observed in car for 30 minutes, drank Pedialyte, discharged home
29 2021-03-22 ear discomfort, mouth tingling, dry mouth about 1 hour after the vaccine, I noticed my right ear felt full and dry mouth. after 1hr and 45 mi... Read more
about 1 hour after the vaccine, I noticed my right ear felt full and dry mouth. after 1hr and 45 minute the right side of my mouth felt tight and tingly (kind of like after you get a numbed at the dentist but your not completely numb) my right thumb felt the same way, and as the night went on the tight, tingly, numb feeling grew across the right side of my face from my lips to my ear. the next morning it was still there, and as the day progressed that feeling grew up to my eye. that is when I was seen by a doctor , who confirmed that what I was experiencing was not a muscle reaction, but a nerve reaction. I can still move my lips and eyes, but it just feels very weird and tight, and almost like I have to work hard to make them move.
29 2021-03-23 mouth numbness, mouth tingling Patient reported to check-out table approximately 13 minutes after receipt of vaccine complaining of... Read more
Patient reported to check-out table approximately 13 minutes after receipt of vaccine complaining of feeling "hot and dizzy". I was called to patient's side to evaluate. A pulse ox was placed and gave a reading of SPO2 100% and HR 80. Quick history was taken and patient was moved outside due to cooler temperatures. Patient was able to ambulate under her own power and did not appear ill or have any signs of respiratory distress or AMS. She did note a sensation of tingling/numbness in her lips after sitting down outside There were no signs of labial edema or edema of the airway. Patient was given cold water and 25mg po Benadryl with improvement in symptoms 25 minutes later. After her extended observation period patient was released from the vaccine site with strict follow up precautions.
29 2021-03-23 mouth tingling ONSET 3/16/2021 FEELING TINGLING ON HER TONGUE; 3/17/021 NOTED RIGHT SIDE FACIAL NUMBNESS WHEN PATIE... Read more
ONSET 3/16/2021 FEELING TINGLING ON HER TONGUE; 3/17/021 NOTED RIGHT SIDE FACIAL NUMBNESS WHEN PATIENT WOKE UP.
29 2021-03-24 mouth numbness Feeling of weakness in L upper/lower extremity; numbness/blunted sensation in L whole upper lower ex... Read more
Feeling of weakness in L upper/lower extremity; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly on the left deltoid, on 11Jan2021 09:55, at a single dose, for covid-19 immunization. The patient's medical history was not reported. The patient's father got thyroid storm from influenza vaccination. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscularly on the left deltoid on 20Dec2020 18:00 for covid-19 immunization at the age of 29-years-old and experienced L face; tongue, L upper; lower, extremity numbness. The vaccine was received at the hospital. The patient experienced numbness/blunted sensation in L whole upper lower extremity, L face, L tongue on 11Jan2021. As treatment, the patient received acetaminophen 650mg po on 11Jan2021. The patient then experienced feeling of weakness in L upper/lower extremity on 22Jan2021. All the adverse events resulted in a visit to an emergency room. The patient was admitted to the hospital due to all adverse events for 2 days, from 02Mar2021 to 04Mar2021. The patient underwent lab tests and procedures on 24Jan2021 which included the following: MRI brain w/wo con with results of negative, MRI spine w/wo con with results of negative, CT head wo con with results of negative, and CXR with results of negative. The patient underwent lab tests and procedures on 02Mar2021 which included the following: MRI head with results of negative, CBC with results of negative, MRI neck with results of negative, MRI brain w/wo con. with results of negative, CMP with results of negative, UDS with results of negative, U/A with results of negative, and B12 with results of negative. The patient underwent lab tests and procedures on 03Mar2021 which included the following: CSF with results of negative, TSH with results of negative, and PT/INR with results of negative. The patient underwent MRI spine w/wo con on 04Mar2021 with results of negative. The outcome of the events was unknown.; Sender's Comments: Causality cannot be excluded for the reported serious events and suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-03-25 tunnel vision Almost immediately after receiving the vaccine I started feeling numbness in my left arm (injection ... Read more
Almost immediately after receiving the vaccine I started feeling numbness in my left arm (injection site), dizzy, nauseous, and experienced tunnel vision. I also started profusely sweating (forehead). I reported my symptoms to the nurse who took my temperature, BP, and heartrate. I had a low grade fever (99 degrees) and slightly elevated BP. I drank water and remained at the site for another 30 minutes and my vitals were checked again before I left.
29 2021-03-27 loss of smell, loss of taste "Pfizer-BioNtech COVID-19 Vaccine EUA" 1st vaccine dose received on 12/29/2020, 2nd dose received on... Read more
"Pfizer-BioNtech COVID-19 Vaccine EUA" 1st vaccine dose received on 12/29/2020, 2nd dose received on 1/19/2021. On 2/1 SARS COV-2 IgG Semi Quantative assay showed strong positive result for COVID 19 antibodies. On 3/25/2021 night developed sore throat, cough and body aches. On 3/26 took PCR Covid-19 test at Urgent Care Center. On 3/27 received positive COVID 19 test results. As of 3/27 and 3/28 developed COVID symptoms (sore throat, congestion, loss of smell and taste, body ache, headache, chills).
29 2021-03-28 taste impairment, tunnel vision tunnel vision; Nausea; dizziness; feeling weak; headache; metallic taste in mouth; left arm/leg pain... Read more
tunnel vision; Nausea; dizziness; feeling weak; headache; metallic taste in mouth; left arm/leg pain; left arm/leg pain; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 11Mar2021 11:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included premenstrual dysphoric disorder (Pmdd), major depression (mdd), anxiety, high cholesterol and allergies: Penicillin, all from an unknown date and unknown if ongoing. No COVID prior vaccination and not COVID tested post vaccination. The patient is vaccinated at a clinic. No other vaccine in four weeks. Other medications reported was yes, however unspecified. It was reported that the patient experienced Nausea, dizziness, tunnel vision, feeling weak, headache, metallic taste in mouth, left arm/leg pain all on 12Mar2021. The outcome of the events was not recovered. No treatment for the events. Information on the lot/ batch number has been requested.
29 2021-03-28 mouth tingling, lip swelling Lip tingling and swelling sensation (similar to dental Novocain abating), dizziness, nausea, and fee... Read more
Lip tingling and swelling sensation (similar to dental Novocain abating), dizziness, nausea, and feeling generalized 'hot' about 15 minutes after vaccine receipt. She was treated with oral Benadryl x1, and it took about 45 minutes for her to normalize. She denies pruritis, urticaria, heart racing, red/watery eyes, rhinorrhea, throat/tongue swelling, cough, wheezing, SOB, CP, emesis. She thinks O2 sat may have been low. She reports diarrhea several hours later x1.
29 2021-03-28 vision blurred Blurry vision for 4-5 days along with a headache
29 2021-03-29 taste impairment Metallic taste Rapid heart beat Headache Numb/tingling feeling throughout body
29 2021-03-29 lip swelling Swelling and blistering in lip around canker sore.
29 2021-03-30 hearing loss Intense vertigo started 4 days later; significant dizziness, feeling room spinning, throwing up ever... Read more
Intense vertigo started 4 days later; significant dizziness, feeling room spinning, throwing up every time I stood up, confusion, muffled hearing in right ear, nausea, diarrhea.
29 2021-03-30 feeling of choking Patient complained of tingling in her ears, chest, and back of throat. Patient denies difficulty bre... Read more
Patient complained of tingling in her ears, chest, and back of throat. Patient denies difficulty breathing, difficulty swallowing, and nausea. BP 131/72, HR 91, O2 sat 95%. Patient assessed by physician and monitored.
29 2021-03-30 sensitivity to light Headache, neck pain, injection site soreness, left arm soreness, fever (100.2°F), chills, sweats, j... Read more
Headache, neck pain, injection site soreness, left arm soreness, fever (100.2°F), chills, sweats, joint aches, nausea, light headed, light sensitivity, decreased appetite
29 2021-03-30 tongue itchiness, swollen tongue 10-15 min after the injection patients tongue started to get itchy and swollen Was escorted to ER, o... Read more
10-15 min after the injection patients tongue started to get itchy and swollen Was escorted to ER, observed for about 4 hours and dosed with dexamethasone injectable - 6 milligrams (1 time) and diphenhydramine injectable - 25 milligrams (1 time). She notes that she wasn't anxious per se, but felt the tingling and inquired with nurse regarding if what she was feeling was normal or not. It seemed to plateau at 30 min, then within 20 min of dexamethasone and Benadryl her tongue swelling resolved. She had taken cetirizine prior to the vaccination.
29 2021-04-01 eye pain Fever, dry cough, diarrhea, nausea, vomiting, no appetite, eyes hurt, joint pain. Took Tylenol PM s... Read more
Fever, dry cough, diarrhea, nausea, vomiting, no appetite, eyes hurt, joint pain. Took Tylenol PM so far for 3 nights. No appetite so have not eaten. If I eat, I have nausea and vomiting. This has been constant for approximately 70 hours now. Fever at second night was 102.8. Fever at third night was 101.9. Might have been higher as nights progressed, was too sick/weak to care about taking temp again. Fever today, the third day, has been off and on but temperature earlier today was 100.5.
29 2021-04-01 eye swelling, swollen tongue Swelling of face and tongue and hives. DAY 2 SEVERE itching around 3lbows and hands that traveled th... Read more
Swelling of face and tongue and hives. DAY 2 SEVERE itching around 3lbows and hands that traveled through both arms, swelling in face again and neck, swollen under eye, the next 2 days are variations of the above except for the swollen eye
29 2021-04-01 mouth numbness Weakness; shaking; numbness of tongue and face mostly right side; numbness of tongue and face mostly... Read more
Weakness; shaking; numbness of tongue and face mostly right side; numbness of tongue and face mostly right side; This is a spontaneous report from a contactable consumer, the patient. This 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 1 via an unspecified route of administration in the left arm (at the age of 29 years-old) on 20Mar2021 at 01:30 PM for COVID-19 vaccination. The patient had no relevant medical history. The patient was not pregnant. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 20Mar2021 at 02:00 PM, the patient experienced weakness, shaking and numbness of tongue and face mostly right side and was hospitalized for the events. Treatment was received for weakness, shaking and numbness of tongue and face mostly right side. The clinical outcome of weakness, shaking and numbness of tongue and face mostly right side was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Field Name: NO days hospitalization Field Value: 1 Field Name: Hospital name Field Value: Name Field Name: Hospital city Field Value: Name Field Name: Hospital state Field Value: Name Field Name: if patient recovered Field Value: Recovering Field Name: if treatment ae Field Value: Yes Field Name: Ae treatment Field Value: Tylenol and fluids with Benadryl Field Name: if covid prior vaccination Field Value: No Field Name: If covid tested post vaccination Field Value: No Field Name Known allergies Field Value: No Field Name Other medical history Field Value: No Information about lot and batch number was requested.
29 2021-04-01 ringing in ears Tinnitus for the last 16 hours, unusual heart palpitations, strange sensations of pain and hot/cold ... Read more
Tinnitus for the last 16 hours, unusual heart palpitations, strange sensations of pain and hot/cold sensations throughout my body.
29 2021-04-02 mouth numbness, vision blurred Patient is a 29 year old female patient who went to County Health ER on 3-1-2021 at 02:52AM with pos... Read more
Patient is a 29 year old female patient who went to County Health ER on 3-1-2021 at 02:52AM with possible complex migraine, vision blurring, and transient aphasia. CT was (-), she needs an MRI and referral to neurology. 1) paresthesia of skin, 2) other migraine not intractable, without status migrainosus, 3) (receptive) aphasia Saturday night(2-27-21) laying in bed looking at her phone and all of a sudden experienced a headache, vision went blurry, thought her eyes were tired and she tried to go to sleep. Headache was in the front of her head. Went to sleep then woke up at midnight, 2 hours later, breathing was off, head was hurting and felt anxious, felt like she needed to pace. Her husband was asking her what she was doing but she could not understand what he was asking. Couldn't figure out what to tell him or how to tell him, she could only say "what?" She then lay down, shaking, hand and tongue went numb. Went to ER, by that point the numbness was gone and she could understand what they were saying. The ER doctor Gave her Cogentin that helped to calm her down. Her head was not hurting all of the time. Gets headaches but not usually migraines. Patient has not had COVID that she knows of, son was negative for COVID in November 2020, but he had COVID-like symptoms. No recent sickness, travelled the first week of February 2020. Denies any weight loss, night sweats, no falls, no rashes, no tripping over her feet, no urinary retention. Yesterday felt light headed and dizzy, felt that she had to focus her eyes a little longer. PE abnormalities on office exam 3-2-2020: Right side smile is more droopy than left. Right side, pt is unable to puff cheeks due to right facial muscles with decreased strength/tone. Right foot has decreased vibratory sense compared to left foot. Left foot slightly decreased vibratory sense, but very slight, right is much worse. Monofilament testing is good/normal in the hands and feet bilaterally. Point to point discrimination testing: 2 mm left hand 3 mm right hand Right foot 11 mm on bottom, 10 mm on top (abnormal) Left foot 12 mm on bottom, 11 mm on top(abnormal) strength 5/5 and reflexes normal 2+ in bilateral UEs and LEs. Mental status is normal. MRI and MRA of brain is advised. EEG study with Dr., neurology, referral made. Check tick borne illness panel, vitamin B, folate, thiamine. (ER labs were unrevealing.)
29 2021-04-02 ringing in ears About 1 to 2 minutes after injection, I got extremely lightheaded and dizzy. I felt myself becoming ... Read more
About 1 to 2 minutes after injection, I got extremely lightheaded and dizzy. I felt myself becoming hot and over the next few minutes became extremely sweaty. There was a loud ringing / buzzing in my ears. I sat down in the chair near the pharmacy for observation and the lightheadedness, mental fogginess, ear ringing and excessive physical sweating lasted for approximately 10 - 12 minutes post injection.
29 2021-04-02 tongue itchiness, swollen tongue, oral mucosal blistering After 10 minutes, tongue started to become itchy, and blisteres formed in and around mouth , tongue ... Read more
After 10 minutes, tongue started to become itchy, and blisteres formed in and around mouth , tongue then began to swell. I took 2 25 mg of Benadryl and was monitored for further reactions by pharmacist.
29 2021-04-05 mouth pain injection site pain, tiredness, headache, muscle pain, chills, injection site redness/rash/itching, ... Read more
injection site pain, tiredness, headache, muscle pain, chills, injection site redness/rash/itching, nausea, swollen lymph nodes (armpits/throat), inside of mouth cheeks/throat very sore, hard to breath, sharp/achy chest pain - sort like bronchitis without the phlegm, potentially high blood pressure but I have no way of measuring it. Have been taking benadryl 2 pills every 4-6 hours since around 15 minutes after dose one, took aleve since yesterday (April 5 2021). As of present (April 6 2021) still experiencing all of the above and feel unwell
29 2021-04-06 dry throat, oropharyngeal discomfort After vaccination, patient was instructed to sit in the waiting area for 15 minutes. Patient states ... Read more
After vaccination, patient was instructed to sit in the waiting area for 15 minutes. Patient states that they experienced feeling flushed, chills, dry, scratchy throat feeling. Observation personnel noticed a minor rash on neck. Patient was evaluated by provider.
29 2021-04-06 oropharyngeal discomfort, feeling of choking Warm and tickling in throat. No signs or symptoms of distress. PS02 100% pulse 99 Respirations e... Read more
Warm and tickling in throat. No signs or symptoms of distress. PS02 100% pulse 99 Respirations even and unlabored. Skin pink warm and dry.
29 2021-04-06 ringing in ears FLU SYMPTOMS, FEVER OF 102 DEGREES, HEADACHE, BODY ACHES, CHILLS, TINNITUS
29 2021-04-06 visual impairment Systemic: Confusion-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances... Read more
Systemic: Confusion-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pt recieved Pfizer vaccine. Pt sat in waiting area afterwards. Pt passed out and experienced sweating and vision impairment. Within 5-10 minutes pt able to respond in usual manner and vision clear again. Pt reports having similar incidents in the past with blood draw.
29 2021-04-07 dry throat Two days after Pfizer COVID-19 vaccine at vaccine clinic patient presents to hospital with HA, mild,... Read more
Two days after Pfizer COVID-19 vaccine at vaccine clinic patient presents to hospital with HA, mild, dry cough, dry throat, and fatigue for three days. SARS-Co-V positive. Managed as an outpatient with OTC medications and improving symptoms on follow-up video visit one week later.
29 2021-04-07 swelling of eyelid Dermal fillers located in my right eye swelled, became black and blue and sore on top of flu like sy... Read more
Dermal fillers located in my right eye swelled, became black and blue and sore on top of flu like symptoms
29 2021-04-07 ringing in ears Tinnitus. Currently ongoing.
29 2021-04-08 ear pain, ear discomfort, hearing loss, fluid in middle ear, extreme sound sensitivity Ear fluid- ear pain, ear and head pressure, muffled and sensitivity to sound. Prescribed Methylpredn... Read more
Ear fluid- ear pain, ear and head pressure, muffled and sensitivity to sound. Prescribed Methylprednisolone and recommended Claritin d. (Pain in the arm day following vaccine went away)
29 2021-04-08 eye discomfort Client reported sudden onset of headache, pressure behind eyes, and nausea around 1142a and itching ... Read more
Client reported sudden onset of headache, pressure behind eyes, and nausea around 1142a and itching reported at 1210p. MD recommendation to monitor apply ice and assess vitals and zofran ordered by MD and administered by cal med. Client refused hospital transport and signed AMA.
29 2021-04-09 lip swelling feet swelling, cheeks, and upper lip. anxiety and increased heart rate
29 2021-04-09 oropharyngeal discomfort, dry mouth Patient reports heaviness in throat and dry mouth post vaccination, but denied shortness of breath a... Read more
Patient reports heaviness in throat and dry mouth post vaccination, but denied shortness of breath and no trouble swallowing. Patient also denies signs of hives or itching, but does report mild "shivers." Patient states that they have not eaten today and has minimal water intake. Patient desired to walk to observation. Benadryl 50mg was given and patient was observed for an additional 15 minutes. Patient walked out with spouse.
29 2021-04-09 vision blurred Patient reports vision became blurry about 5 to 10 minutes after vaccine. Husband reports "she was t... Read more
Patient reports vision became blurry about 5 to 10 minutes after vaccine. Husband reports "she was talking, then she was out". On arrival to car, patient was pale, awake, a little confused. Cool air, cool compress, and reclined seat applied. Color returned. VSS. Patient reported feeling better though with nausea. Gradually improved. Able to take Gatorade. Observed for 30 min. Vss throughout. D/c home in care of husband.
29 2021-04-11 loss of smell VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being ... Read more
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose: 12/23/20,PFIZER,Lot#EK9231 2nd dose:01/11/21,PFIZER,Lot# el3248 Diagnosed covid positive:04/01/21 Exposure:Unknown Symptoms:sob,fatigue,congestion,loss of smell,fever
29 2021-04-11 blindness Patient started experiencing a feeling of warmth about 15 to 20 minutes post injection. Then partial... Read more
Patient started experiencing a feeling of warmth about 15 to 20 minutes post injection. Then partial vision loss, chest heaviness, left- side numbness, Jaw tightness. Around 12:40 we called 911 and she was taken by ambulance to Medical center for evaluation. 911 operator instructed us to give 4 Aspirin 81mg.
29 2021-04-11 lacrimation increased In the 24 hours after getting the first dose of Pfizer I experienced shortness of breath and runny e... Read more
In the 24 hours after getting the first dose of Pfizer I experienced shortness of breath and runny eyes and a scratchy throat
29 2021-04-11 lip swelling, feeling of choking One half hour post injection I began feeling a tingling in my throat. It progressed to swelling, whi... Read more
One half hour post injection I began feeling a tingling in my throat. It progressed to swelling, which made it more difficult to breathe. My lips swelled a bit and a white line formed on them. I took two 25 mg tablets of Benadryl. I began feeling better about an hour later. I also started my period the morning of the shot. The next morning, my period stopped.
29 2021-04-11 swollen tongue Hives all over body about 80% of the entire body. Swollen face, tongue and throat felt compressed. S... Read more
Hives all over body about 80% of the entire body. Swollen face, tongue and throat felt compressed. Started exactly 24hours after shot and lasted 4 days. On the 2nd day of the symptoms is when my face and tongue became swollen and my throat felt like there was an arm around it.
29 2021-04-11 swollen tongue Received a call 1650 c/o tongue swollen and feeling like it has "pins and needles". Denies any diffi... Read more
Received a call 1650 c/o tongue swollen and feeling like it has "pins and needles". Denies any difficulty breathing. Able to speak clearly without any audible signs of distress. Received dose of vaccine at 1600 today. Originally called our call center who instructed her to call 911.She refused stating she just wanted to take Benadryl. Call transferred to me. Instructed that per our Emergency medical orders, Benadryl is for urticaria, not for swelling of airway. Instructed to call 911. She declined stating she wanted to try Benadryl first. Explained that a blocked airway can happen fast and she doesn't want to risk waiting too long. Epi is recommended. She states she has a severe allergy to bees (which she did not list on the registration form--so only had a 15 minute wait versus 30 after her injection)--She states she has 6 epi pens readily available with her. Confirms she has someone there with her. Instructed that my recommendation would be to call 911, but if she isn't going to do that she needs to have her epi pens ready and available and ensure that the person she is with knows how to use them. If she develops any trouble breathing, they need to give epi and call 911, then repeat dose every 5-10 minutes until paramedics arrive. She agrees with that plan. Agrees to have another nurse call her later to f/u. Called again several times that evening by RN--at 1735 she was advised to use her epi pen and call 911, she declined. She finally had boyfriend drive her to ER to "sit in parking lot" in case something got worse. enc to have boyfriend go into ER and alert them. RN also called ER to give them an alert. Continued to decline to use Epi pen. Declined to let RN speak to boyfriend either. Rn tried to call her later and she didn't answer. RN left a message, but she didn't call back.
29 2021-04-11 ringing in ears Ears ringing - high pitched noise - intermittent
29 2021-04-11 ringing in ears 4 months pregnant, dizzness, sweaty shortness of breath, hearing buzzing in ears
29 2021-04-12 swollen lips, mouth numbness Patient had numbness on the right side of her tongue and irritation on her lip. We gave her benadry... Read more
Patient had numbness on the right side of her tongue and irritation on her lip. We gave her benadryl and she immediatelly felt better. This all happened within 30 min
29 2021-04-12 dry mouth, mouth discomfort Dizziness, dry nd burning sensation in mouth
29 2021-04-12 pain in jaw Fever, peaking at 101.5 F, starting at approx 2 am 4/12 lasting until approx 4 pm. Severe nausea fro... Read more
Fever, peaking at 101.5 F, starting at approx 2 am 4/12 lasting until approx 4 pm. Severe nausea from 2 am 4/12, lessening but continuing through following day (the day this report is written). Mild vomiting and diarrhea at 7 am 4/12 not continuing. Severe jaw pain starting 48 hours after vaccination (approx 12 pm 4/13) on right side of jaw, constant and intense, not limiting ability to move but preventing focus on tasks. Mild pain in some lymph nodes, mild headache, moderate fatigue not inconsistent with having been recently ill. All symptoms dealt with by patient without seeking medical intervention. OTC anti-nausea was taken without relief.
29 2021-04-13 taste impairment Metallic taste in mouth for 4 days. Odd taste sensation. Early onset of mensural cycle.
29 2021-04-13 lockjaw 29 yo Female reported after last vaccine hives that resolved next day with Benadryl and single brief... Read more
29 yo Female reported after last vaccine hives that resolved next day with Benadryl and single brief dizziness described as insignificant before vaccine. Upon walking to the bathroom during the 30 minute wait time, escort noted patient appeared to be in need of assistance so he offered her a chair. Upon sitting, she slumped against him so he asked for medical assistance. EMS called. On the ground patient was unresponsive with shallow breathing; neck was hard to move but attributed to her large bun. Stethoscope used to hear breath sounds as nurse reported she was breathing but did not appear to be strong breaths. Pulse ox 96% or higher with BP appropriate, HR in 90s. She awoke to sternal rub, nurse asked her if she had difficulty breathing after noting her jaw was rigid and unable to open. Patient indicated yes to difficult breathing so epinephrine was given. ~ 30 seconds after epinephrine patient alert and breathing deeply, began to respond to questions. After reporting breathing was still moderately difficulty (a few minutes later), epinephrine second dose given. Patient transport via EMS.
29 2021-04-15 eye pain Extremely cold (fingers and toes became numb), aching bones/joints, itchy skin, hives, headache, fev... Read more
Extremely cold (fingers and toes became numb), aching bones/joints, itchy skin, hives, headache, fever, extreme sweating, sore throat, hoarse voice, sore throat, runny/stuffy nose, eye pain, fatigue, nausea, lack of appetite, confusion, feeling like my body was moving in slow motion
29 2021-04-15 mouth tingling, mouth numbness Patient experienced numbness and tingling of tongue during observation period. Denies any issues wi... Read more
Patient experienced numbness and tingling of tongue during observation period. Denies any issues with throat or other symptoms.
29 2021-04-15 ringing in ears Limbs falling asleep easily, tingling, ringing in ears, nausea, headache.
29 2021-04-16 swelling around the eyes, eye discomfort, eye pain About four days after I received my 2nd Pfizer vaccine shot, I developed severe dark, red, puffy und... Read more
About four days after I received my 2nd Pfizer vaccine shot, I developed severe dark, red, puffy under eyes. There was a stinging sensation and I experienced great discomfort. I am on day four and the swelling/redness has gone down, but my under eyes are still very dry and raw.
29 2021-04-16 feeling of choking Pt presented to EMS with a complaint of tingling in her throat. PMHx of anxiety, depression and migr... Read more
Pt presented to EMS with a complaint of tingling in her throat. PMHx of anxiety, depression and migraines. Allergies to Tylenol, Antibitocs, Sulfa, nuts, Ibuprofen, shea butter She was taken to hallway where her vitals were assessed. Vitals assessed twice with five minutes between both sets. First set of vitals: BP105/76 HR90 SPO2 100% Second set of vitals: BP98/68 HR90 SPO2 100% Vitals are within normal limits. Airway was assessed. No tongue swelling or airway compromise noted. Pt was given water and she was able to swallow without any difficulty. Pt stated it might just be her anxiety. Pt stated she was feeling better and was brought out into arena so she could finish her observation time.
29 2021-04-16 ringing in ears Intermittent unilateral tinnitus. Completely resolved after 3-4 weeks.
29 2021-04-16 visual impairment, deafness Dizziness, nausea, seeing black spots, loss of hearing, having difficulty speaking, neurological dis... Read more
Dizziness, nausea, seeing black spots, loss of hearing, having difficulty speaking, neurological disorientation for roughly 25 minutes. (Unable to answer nurses questions or understand the questions being asked)
29 2021-04-17 loss of taste, loss of smell, dry throat, inability to speak there is clear liquid or mucus when she blows her nose and her nose is constantly running and she fe... Read more
there is clear liquid or mucus when she blows her nose and her nose is constantly running and she feels it in the back of her throat; her nose is constantly running and she feels it in the back of her throat; Tested positive for covid; Coughs up little specs of blood with dry cough; Fever; Feels a little weak at night sometimes; Light to mild cough; Losing her voice; Dry throat; Having problems breathing because of nose and throat; Loss of sense of taste and smell; Loss of sense of taste and smell; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6205; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in arm left on 16Mar2021 12:30 as single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient experienced Dry throat, light to mild cough, Having problems breathing because of nose and throat, loss of sense of taste and smell, Losing her voice on 26Mar2021. The patient experienced fever, feels a little weak at night sometimes on 27Mar2021. The patient was tested positive for covid on 28Mar2021. She coughs up little specs of blood with dry cough on 28Mar2021. There was clear liquid or mucus when she blows her nose and her nose was constantly running and she felt it in the back of her throat. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Mar2021. Therapeutic measures included Nyquil were taken as a result of fever, feels a little weak at night sometimes, dry throat, light to mild cough. The outcome of events tested positive for COVID-19 was unknown, fever was recovered with sequelae, feels a little weak at night sometimes, light to mild cough, coughs up little specs of blood with dry cough, loss of sense of taste and smell, losing her voice was recovering while dry throat, having problems breathing because of nose and throat was not recovered. Information on Lot/Batch number was available. Additional information has been requested
29 2021-04-17 swollen tongue passed out from exhaustion; Fever; was unable to stand unassisted.; writhing in pain/so much pain; i... Read more
passed out from exhaustion; Fever; was unable to stand unassisted.; writhing in pain/so much pain; in and out of consciousness/passed out; tongue swelled up, making it hard to breathe and impossible to speak; tongue swelled up, making it hard to breathe and impossible to speak; tongue swelled up, making it hard to breathe and impossible to speak; sweating profusely; couldn't support her own body without tipping over.; seizure; lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain; lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain; chills; extreme muscle pain; spasms; This is a spontaneous report from a non-contactable consumer (patient herself). A 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 13:15 (Batch/Lot Number: ER8737) as single dose, for COVID-19 immunisation. Medical history was reported as no. Patient did not have COVID-19 prior to vaccination. Patient did not receive other vaccines within 4 weeks prior to COVID-19 vaccine. Patient's concomitant medication includes omeprazole, ethinylestradiol, levonorgestrel (MARLISSA), venlafaxine and gabapentin from unspecified dates, received within 2 weeks of vaccination, for unspecified indication. Patient historically took first dose of Pfizer BNT162B2 (Lot number: EN6204) on 13Mar2021 at 11:00 AM on the left arm for COVID-19 immunisation. Patient previously took hydrocodone bitartrate, paracetamol (VICODIN) on an unspecified date and indication and had allergy. On 02Apr2021, around 10pm, patient began having chills and extreme muscle pain and spasms, and the lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain. By midnight (03Apr2021 00:00), patient had a fever and was unable to stand unassisted. She was writhing in pain and arching uncontrollably off the bed. She believed in hindsight that this was a seizure as she went in and out of consciousness and her tongue swelled up, making it hard to breathe and impossible to speak. She was sweating profusely, and had to drink water constantly. Her husband had to help her get to the bathroom because she couldn't support her own body without tipping over. The chills and fever alternated all night, and she finally passed out from exhaustion at 03Apr2021 at 7am. The next 2 days, she was in a cycle of fever and chills again, and the fever got so bad that she seized twice more on Saturday (03Apr2021). She had to take the day off work on Monday (05Apr2021) as she was still in so much pain that she could barely leave bed except to use the bathroom. Events were reported as life-threatening, immediate risk of death from the events. Patient was not hospitalized. Treatment for the adverse events were cool baths, naproxen (ALEVE) for fever and pain, and PEDIALYTE. COVID-19 was not tested post vaccination. Vaccination facility type was at a hospital. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
29 2021-04-18 mouth numbness, mouth tingling A couple days after my first dose, I experienced intermittent numbness and tingling in my lips (no s... Read more
A couple days after my first dose, I experienced intermittent numbness and tingling in my lips (no swelling). Each episode lasted for anywhere from 30 seconds to 2 minutes. This lasted for about 4 days. Additionally, about 4 days after my first dose, I also woke up with a red itchy rash under my left eye.
29 2021-04-18 lip swelling began with a thick throat and lips and face began to swell - left side was more swollen than the lef... Read more
began with a thick throat and lips and face began to swell - left side was more swollen than the left, began taking Benadryl but it took almost 3 full days for it to go down.
29 2021-04-18 mouth tingling Within 2 minutes of receiving the vaccine pt stated "I don't feel well" and was noted to be very flu... Read more
Within 2 minutes of receiving the vaccine pt stated "I don't feel well" and was noted to be very flushed all over with hives noted on chest and arms. Pt placed supine and evaluated by EMS. Pt stated that she felt some tingling around her mouth. Lungs clear, no difficulty breathing. Tachycardic at 104 bpm. IM diphenhydramine administered to R deltoid by EMS with immediate improvement in symptoms noted. HR decreased to 79 BPM with flushing and hives decreasing. Transferred to EMS for transport to ED for evaluation.
29 2021-04-19 taste impairment 29 y/o female, past medical history of HTN (unmedicated) and Arrythmia (type unknown), who presents ... Read more
29 y/o female, past medical history of HTN (unmedicated) and Arrythmia (type unknown), who presents with left facial, neck and left upper extremity numbness onset set shortly after vaccination. Patient states that this is her 1st dose in the two-dose series, and she has never had a reaction to vaccinations in the past. NP and Paramedics at patient side. Water was provided to patient and legs elevated. Patient facial features symmetrical with no facial droop, equal strength and pulses to the upper extremities. Stroke scale negative. Patient also states a weird iron like taste to her mouth, a very strong taste but states that she can swallow without difficulty. Patient noted to be Hypertensive (155/103 R) on initial vitals, all other vitals within normal limits. Repeat vitals showed that patient remained Hypertensive (156/91, 145/103, 158/106, 160/84). Patient was then moved (ambulated to the gurney) and placed behind the partitions for privacy. At this time, EKG was performed with NSR. Patient stated that the numbness to her left arm and neck had resolved but remained with the iron taste to her mouth and slight numbness to her left cheek. Repeat EKG was performed and showed an Arrythmia (per Paramedics). At this time, due to elevated BP and facial numbness Fire Rescue was notified via Police Officer on detail. Hialeah Fire Rescue arrived at the site and assessed patient on the truck. Per Fire Rescue, it was noted on EKG that patient in AFib. Patient declined transport to the ER for further evaluation and signed Against Medical Advice with Fire Rescue and as well with Logistics team and Healthcare workers. Patient was ambulated to her car with the NP at her side. NP advise patient to seek further medical evaluation due to her risk of stroke, worsening arrythmia leading to cardiac event and/or possible death. NP also advise patient to obtain a primary care provider and cardiologist to address her Hypertension and Arrythmia. Patient verbalized understanding.
29 2021-04-19 mouth itchiness, swollen tongue, burning mouth syndrome, mouth tingling, lip swelling 48 hours after the vaccine my mouth began itching after eating. It happened during breakfast and lun... Read more
48 hours after the vaccine my mouth began itching after eating. It happened during breakfast and lunch this day, and then the next morning at breakfast, which is when I became worried. My throat began feeling tight, felt like it had mucus in it and I needed to clear it. My mouth was itching and my tongue felt tingly. Four days after the vaccine my tongue started to swell so I called my doctor. I saw him the Tuesday, 3/2 after the vaccine and he said my thyroid was swollen and felt I was having an allergic reaction to the vaccine. He did an allergy panel and lab work for my thyroid, all tests came back within normal limits. He referred me to an allergist and said to take benadryl every six hours. A few days later my bottom lip started to swell and my tongue ached. I was also having intermittent chest pains for about five weeks. Then my lymph nodes in my throat started throbbing. I saw the allergist on 4/6 and he advised to cancel the second dose. He did lab work to check for autoimmune disorders and inflammation but tests came back normal. He advised on 4/19 to take allegra two times a day for three weeks and we will follow up. Ongoing symptoms are mouth itching after eating, tingling in throat, and itching on throat and neck, and on and off swelling of my bottom lip. I have also experienced lightheadedness and ocular migraines.
29 2021-04-19 swollen tongue After receiving first COVID vaccine, patient became lightheaded, nearly passed out, and nauseased. P... Read more
After receiving first COVID vaccine, patient became lightheaded, nearly passed out, and nauseased. Patient was hypotensive and tachycardic, feeling chest tightness and lump in her throat. the sensation of tongue swelling occurred in the ED. Vitals were performed and the patient was given fluids. Initial vitals were 80/52, HR 89, O2 97% on RA while sitting up right. After 15 more minutes and after providing 400 ml to drink, her BP was 115/80 O2 sats 100%. When cardiac symptoms and throat sensation were expressed, the an RRT was called and the patient was taken to the ER for observation. In the ED she was given juice and observed. She was later discharged after monitoring.
29 2021-04-20 taste impairment Shortly after vaccination began to c/o nausea, chills, and a metallic taste, became diaphoretic
29 2021-04-20 ear discomfort Pt. reported throat and ears burning as well as burning at the injection site. Pt. has history of an... Read more
Pt. reported throat and ears burning as well as burning at the injection site. Pt. has history of anxiety, vital signs checked and WNL. Pt's symptoms began to improve over time. Pt. released home after being evaluated for additional 10 minutes.
29 2021-04-20 swollen tongue, lip itchiness, lip swelling, mouth numbness, tongue itchiness Day 1, dizziness, swollen face, neck, and tongue and I went to the facility again 3 hours post injec... Read more
Day 1, dizziness, swollen face, neck, and tongue and I went to the facility again 3 hours post injection. They assessed and called 911 to take me to their hospital. Also had breakout on my face of tiny hives. The ER told me to take prednisone, xyzal, benadryl, and pepcid for the next 3 days. Day 2, swollen lips, swelling under my right eye and face, itchy lips, arms, elbows, and hands. Itchy and numb tongue. Day 3, today, neck and lips swelling, some itchiness. Some face swelling. The itchiness is increased in my face and lips. Day 4, almost no swelling but had itchiness and swollen lips. The symptoms came on and off throughout all days.
29 2021-04-20 vision blurred Patient reported feeling lightheaded and some blurry vision. Patient reports that she always feels l... Read more
Patient reported feeling lightheaded and some blurry vision. Patient reports that she always feels lightheaded after getting vaccines. Patient usually takes Zoloft daily for anxiety but missed her dose that day. Patient appears slightly pale. Patient was offered snacks, juice, and water but declined. 30 minutes later patient reports feeling a lot better and denies all prior symptoms.
29 2021-04-20 vision blurred Complained of nausea, blurred vision, tingling of hand and foot. Symptoms were resolved and patient ... Read more
Complained of nausea, blurred vision, tingling of hand and foot. Symptoms were resolved and patient went home.
29 2021-04-21 loss of taste, taste impairment Body aches; chills; fatigue; loss of taste; metallic taste. Lasted about 48 hours after onset of sym... Read more
Body aches; chills; fatigue; loss of taste; metallic taste. Lasted about 48 hours after onset of symptoms. Symptoms began about 14 hours after vaccination. Treated with OTC medication and rest.
29 2021-04-21 eye itchiness, eye swelling Swollen and itchy left eye
29 2021-04-21 lacrimation increased My symptoms started on the 4th day after the injection of the first dose of my Covid-19 vaccine. It ... Read more
My symptoms started on the 4th day after the injection of the first dose of my Covid-19 vaccine. It started with watery eyes, and itchy throat. The following day this developed into congestion and sore throat in addition to a fever, chills, body aches, and nausea. All symptoms persisted for two more days except for a fever.
29 2021-04-22 taste impairment, mouth tingling PT C/O TINGLING IN HER MOUTH, METALIC TASTE 25 MINS AFTER 2ND DOSE. ELEVATED BP, TARNSFERED FOR FURT... Read more
PT C/O TINGLING IN HER MOUTH, METALIC TASTE 25 MINS AFTER 2ND DOSE. ELEVATED BP, TARNSFERED FOR FURTHER OBSERVATION.
29 2021-04-22 pain in jaw Jaw pain and numbness on left side under ear Body aches Chills
29 2021-04-25 eye pain, lacrimation increased Pfizer-BioNTech COVID-19 Vaccine EUA 4/23 - in the evening swelling and soreness around the point of... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 4/23 - in the evening swelling and soreness around the point of injection on the left arm 4/24 - Woke up feeling a sharp pain on the left collar bone. the swelling and soreness continued on my left arm. the pain on the collar bone continue throughout the day and moved to the upper part of my left shoulder. 4/25 - the pain continued on the left collar bone and upper part of my left shoulder. the swelling and aching on the left arm dimmed down close to none existent. 4/26 - woke up feeling an ache in my left eye, there was no redness but the my eye would get watery. the pain on the left collar bone and upper part of my shoulder has decreased but I can still feel some aching in those areas. the swelling in the left arm and aching has completely gone away.
29 2021-04-25 eye swelling, swollen tongue, mouth swelling Site: Itching at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Diff... Read more
Site: Itching at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
29 2021-04-25 mouth swelling, swollen tongue, eye swelling Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Aller... Read more
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
29 2021-04-25 tongue itchiness Itchy tongue
29 2021-04-26 ear pain, ear discomfort Dizziness, vertigo, ear fullness, ear pain, face numbness for more than 2 weeks. Treatment 1: Anti... Read more
Dizziness, vertigo, ear fullness, ear pain, face numbness for more than 2 weeks. Treatment 1: Antibiotics + decongestant Treatment 2: Steroids (10 days) + nasal spray.
29 2021-04-26 lip swelling Skin blotches around left side of face, lower lip swelled referred to aa a cherry, itchy ear, scratc... Read more
Skin blotches around left side of face, lower lip swelled referred to aa a cherry, itchy ear, scratchy throat similar to a strobe light effect within 10 minutes of injections. Spoke with medical personals and she took a Benadryl pill. We waited 40 minutes then left. The swelling blotches started to stop, however at this time she cannot lift her arm at all, her chronic leg pain shot up to her groin area and a migraine has occurred. Gave her Acetaminophen has not help. Notified her primary care physician who advised that she refrain from taking second dose.
29 2021-04-26 chewing disorder, eye movement disorder, pain in jaw Approximately 1.5-2 hours after receiving the Pfizer-BioNtech COVID-19 vaccine (lot ER2613,) at appr... Read more
Approximately 1.5-2 hours after receiving the Pfizer-BioNtech COVID-19 vaccine (lot ER2613,) at approximately 8:40 am on 4/26/21, I started having mild jaw pain. At about 4 pm that afternoon the jaw pain worsened to the point where I was unable to chew without pain. Around this time, I started having chills. Immediately pre- and post- vaccine I was alternating Tylenol and Motrin every 6 hours. At around 11 pm that night I was experiencing chills and myalgias. Between 1-2 am on 4/27/21, I started experiencing right-sided facial drooping. I found it difficult to open my right eye and my entire face felt numb. The jaw pain was even more severe with these symptoms, and I had to pry my right eye open by tugging at my eyebrow region. Given enough time, I could get the eye open and my face began to look normal. I would lie back down and have the same difficulty each time I got up to use the restroom. These symptoms started lessening until they completely resolved between 7-8 am on 4/27/21. I have had similar symptoms with migraines (possible hemiplegic migraines) in the past, but I did not experience any headache with these symptoms. Now it is 11:44 am on 4/27/21 and the only symptom that remains is general malaise and mild myalgias. I thought about going to the emergency dept during the night due to the facial drooping, but ultimately decided to wait it out.
29 2021-04-26 swollen tongue Within 30 minutes I felt tingling and numbness in my left arm, right arm, and face, shortly followed... Read more
Within 30 minutes I felt tingling and numbness in my left arm, right arm, and face, shortly followed by tightness in my chest and throat, slight swelling of the tongue accompanied with a dizzy feeling and hugh blood pressure when usually good or normal. When administered benadryl the tightness and swelling subsided, but two hours later followed with heat and itchiness felt from head to toe almost inside the body. For 3-4 days nausea, dizziness, slight headache, feeling extremely hot in the core and itchiness came and went.
29 2021-04-27 canker sore I received the second dose of the Pfizer vaccine on Friday April 9th at 6pm. I did not feel any adve... Read more
I received the second dose of the Pfizer vaccine on Friday April 9th at 6pm. I did not feel any adverse effects beyond arm soreness around the injection site until the morning of Sunday April 11th, at which point I had exacerbated joint pain (likely an inflammation response). In the evening of the 11th, I noticed the soft tissues of both my mouth and vulva felt more raw/sensitive than usual. On the 12th this feeling persisted, with canker sores/mouth ulcers forming in my mouth/throat and a continued stinging/irritated feeling in my vulva. On the 13th this manifested as vulval ulcers, which were painful on their own and with pain dramatically increased while urinating. During the night of the 13th/morning of 14th I also woke up several times feeling either chilly/clammy or overheated, and took 800mg ibuprofen and slept through to the morning of the 14th. By the time I woke up I no longer had chills/fever symptom, but mouth and vulval ulcers had both progressed. The appearance of the vulval ulcers was crater-like patches with a white coloration surrounded by raised red rims, with several touching/against each other and surrounding tissue also inflamed/sensitive. On the 15th I made an appointment with urgent care as I was unable to use the bathroom without extreme pain and was unable to wipe the area and had to rinse in the shower to stay clean instead. From the Urgent Care clinician I was prescribed a 5% topical lidocaine ointment, a 4% over the counter lidocaine alternative option, and an antiviral course of Acyclovir. Bloodwork was done to rule out STIs. Applying the ointment 4-5 times a day before using the bathroom was the most effective part of treatment, although constant discomfort and inability to wear tight clothing/wash the area normally persisted for the following week. At peak, there were 10 visible ulcers ranging from 0.3cm-0.8cm in diameter, located on both inside sides of the labia and with some presenting as "kissing sores". After April 20th, they slowly grew smaller and began to recede although intense pain persisted. At this point my mouth sores had also diminished and were fading at a faster rate than the vulvar sores, with minimal disruption to function besides avoiding particularly sharp/spicy/salty foods. I kept up use of the topical numbing cream on the vulvar ulcers until April 26th, at which point most sores had healed and I was able to urinate and bathe in a normal manor, although I still needed to be gentle/the area still felt sensitive. At the time of writing this report (April 28th), I still see some redness/potential scarring but there are no longer open sores and there is no noticeable pain/sensitivity.
29 2021-04-27 ear discomfort I had a server allergic reaction, my body instantly became covered in hives. My skin was burning, th... Read more
I had a server allergic reaction, my body instantly became covered in hives. My skin was burning, the nurse made my lay down, she put the oxygen monitor on my right pointer finger my heart rate was very high almost 200 bpm. Another nurse tried to get my blood pressure she couldnt multiple times, it was below 80. They called EMS, they had to hook me up to multiple monitors. it took over an hr for my heart rate to come down and my blood pressure to rise. The hives were very itchy, my ears were very red and burned badly. I didnt go to the hospital I went home and took 3 over the counter benadryl. The sympttoms lasted over the period of 4 hrs.
29 2021-04-27 ringing in ears Tinnitus in both ears (ringing sound) that started a few days after vaccination and hasn't reduced i... Read more
Tinnitus in both ears (ringing sound) that started a few days after vaccination and hasn't reduced in volume since
29 2021-04-28 loss of smell, loss of taste Cough, new loss of taste or smell
29 2021-04-28 tunnel vision Patient is a 29 yo F with PMHx of psoriasis who presented for dose #1 of Pfizer vaccine, she receive... Read more
Patient is a 29 yo F with PMHx of psoriasis who presented for dose #1 of Pfizer vaccine, she received her vaccine without issues and was being monitored for 15 minutes as recommended. Within her first 10 minutes of being monitored patient notified the staff that she felt warm, within one minute from her complaint of feeling warm she had a full general tonic clonic seizure in her chair for about 15 seconds with associated diaphoresis and thready pulse. Seizure activity broke spontaneously and pt was AO x 3. 911 was called immediately, she was transferred to our medical observation area for further monitoring and examination. Her initial vitals after seizure activity T: 97.5, HR 69, BP 130/77, 02: 98%, BS within first 10 minutes of monitor without food/water was 134. Exam: GEN: AO x 3 HENT: nc/at, anicteric sclera, EOMI CV: regular, nl s1, s2, no mrg PULM: clear bilaterally NEURO: grossly intact SKIN: clammy Upon further questioning pt states she had a similar response while in college to Yellow Fever vaccine but never had an evaluation. She has had vasovagal events with other vaccines and blood draws. She denies any neurological history other than seizure like activity with Yellow Fever vaccine. She states she had an aura with tunnel vision and feeling warm similar to when she had Yellow Fever vaccine. She denied any nausea, she was alert and oriented x 3 after resolution of seizure activity. She was transported to ED for further evaluation. Report was provided to at ED. Seen by Neuro on 4/23/21: Interim History: Patient is a 30 yr, right-handed woman with no significant medical history who is referred for evaluation of an episode of LOC. The episode occurred on 4/9/2021,10 minutes after receiving the 1st dose of the COVID-19 Pfizer vaccine. She reports feeing anxious after receiving the dose because of the history of having passed out after receiving vaccines. As with the previous events, she felt "hot and clammy" and had tunnel vision before losing consciousness for approximately 15 seconds. She was told that she "shook all over" for a few second. Upon regaining consciousness, she was oriented almost immediately and was not confused. The episode occurred while sitting. Patient reports a history of at least 5 syncopal events, since age 12 yr, with 4 of these occurring while sitting and 2 while standing. All of the evens have occurred either after receiving vaccines in 2016 or undergoing medical procedures. Two of the events also include shaking movements but none have been associated with tongue biting, urinary incontinence or post event confusion. She also reports a history of episodes of lightheadedness with postural changes but denies palpitations, CP or SOB. She has never had a neurological or cardiac evaluation. There is a history of a mild concussion while playing soccer. There is no history of CNS infections, febrile seizures or family history of neurological disease. Other Medications: ? adapalene, APPLY TOPICALLY NIGHTLY. APPLY A THIN LAYER AT NIGHT TO ACNE-PRONE AREAS. START EVERY -OTHER NIGHT AND ADVANCE AS TOLERATED ? clindamycin-benzoyl peroxide, APPLY TOPICALLY TWO TIMES A DAY Problems: has Vasovagal syncope on their problem list. Permission to discuss medical information with: Referring MD / Other MD(s): Current Providers PCP: APRN Referring Provider: APRN Care Team Provider: APRN Allergies: Allergies Allergen Reactions ? Pfizer Covid-19 Vaccine (Eua) [Covid-19 Vacc,Mrna(Pfizer)(Pf)] Seizures ? Bactrim [Sulfamethoxazole-Trimethoprim] Rash Medical History: has a past medical history of Psoriasis and Vasovagal syncope. Psychiatric History: none Family History: family history includes Depression in her brother; Heart murmur in her mother; Hypertension in her father. Social History: Social History Tobacco Use ? Smoking status: Never Smoker ? Smokeless tobacco: Never Used Substance Use Topics ? Alcohol use: Yes Alcohol/week: 0.0 - 2.0 standard drinks Review of Systems: ROS Objective: BP (!) 166/99 | Pulse (!) 105 | Temp 97.7 °F (36.5 °C) | Resp 14 | Ht 5' 7" (1.702 m) | Wt 56.7 kg | SpO2 99% | BMI 19.58 kg/m² The BP obtained after the consultation was 145/89 Neurologic Exam Physical Exam General: well appearing, well nourished, no distress, normal affect, cooperative. No rashes or skin lesions. Peripheral pulses intact throughout. Mental Status: Orientation: Alert, oriented to time, place and person. Memory: Remote and delayed recall intact.. Language: Speech fluent. Able to name, repeat and follow three step commands. CN: II: Full visual fields, fundi normal, PERRL. III, IV, VI: EOMs full, no nystagmus. V, VII: Facial sensation and movement intact. VIII: Hearing intact. IX, X: Palate elevates normally. XI: Normal. XII: Tongue midline. Motor: Normal bulk and tone. 5/5 power throughout. No pronator drift. FFMs quick and accurate bilaterally. Coordination: Normal FTN. No tremor. Sensation intact to light touch in all 4. Reflexes: 3/4 and symmetric throughout with downgoing toes. Gait: Normal, including tandem Romberg: Negative Assessment Patient is a 30 yr old woman with a recent episode of LOC that is consistent with convulsive syncope, despite occurring while sitting, 10 minutes after receiving the first dose of the COVID-19 vaccines. She has a history of similar episodes occurring after vaccinations or medical procedures. She reports episodes of pre-syncope and postural lightheadedness. She does not have risk factors for epilepsy and the episodes have an atypical duration for convulsive seizures. In my opinion, the recent event is not an allergic reaction to the vaccine and there is no contraindication for receiving the 2nd dose. Plan: I suggested taking lorazepam 1 mg prior to getting the 2nd dose of the COVID vaccine and to consider consultation with a cardiologist at some future time (but not required prior to obtaining the 2nd dose). I did not recommend an EEG or brain MRI scan. Follow-up will be on a PRN bases.
29 2021-04-28 vision blurred, visual impairment 1 week after 2nd vaccine my vision started getting weird, lines through it, fuzzy vision, , felt the... Read more
1 week after 2nd vaccine my vision started getting weird, lines through it, fuzzy vision, , felt the world was spinning around me, head fog, made me feel weir dand out of it. So far its been 7 days of it. I had an eye exam and they said everything looked good and normal and my glasses prescription had not changed. But they have seen about 5 other patients with similar symptoms after they had got their vaccines too. They are wondering if its linked to the vaccine, I have not had eye issues or symptoms like this ever! My eye Dr. had called another local eye doctor in our area asking if he had also seen this happening too and he said yes, and is taking 2-3 months to resolve.
29 2021-04-29 swollen lips Rash around lips, upper chest. no edema
29 2021-04-29 swollen lips Rash around lips, and upper chest. No edema or airway obstruction.
29 2021-04-29 double vision Patient denies any significant history of headache. About one hour after second dose of Pfizer vacci... Read more
Patient denies any significant history of headache. About one hour after second dose of Pfizer vaccine, she developed a progressive headache that ultimately led to Urgent care visit that evening. Discharged but then returned to ER overnight due to worsened headache. HCT negative. headache continued next four days. 4/23/21 developed diplopia. 4/25 returned to ER due to this and increase in headache. Findings of papilledema, HCT again negative. Lab work with mild leukocytosis ~13 and thrombocytosis ~490. LP opening pressure >55mm H2O with diagnosis of Intracranial Hypertension. Acetazolamide started. Neurology consult 4/28/21 showing R eye abducens palsy. MRI/MRV with contrast 4/29/21 shows severely narrowed transverse sinuses but NO evidence for venous sinus thrombosis. Currently awaiting catheter venography to confirm this with consideration of further management. Adverse event appears to be potential acute exacerbation of Intracranial hypertension related to possible baseline anatomic narrowing of transverse venous sinuses. currently further evaluation to try and absolutely rule out acute venous sinus thrombosis though no evidence of this on MRVenogram with gadolinium contrast.
29 2021-04-29 swollen tongue Approx 4-5 hours post vaccination pt started a systemic allergic reaction that has progressed to req... Read more
Approx 4-5 hours post vaccination pt started a systemic allergic reaction that has progressed to require steriods and she had two episodes of SOB and tongue swelling that have resolved but are worsening in severity.
29 2021-04-29 toothache First day: vaccinated on Monday at noon Arm hurt Tired 12 hours later - Tuesday - fever, chills Feve... Read more
First day: vaccinated on Monday at noon Arm hurt Tired 12 hours later - Tuesday - fever, chills Fever all day Tuesday and body aches Went to bed Tuesday night with a 101.7 fever Broke fever at about 36 hours Wednesday - Woke up feeling pretty normal but had really sensitive teeth As the day persisted my lungs started hurting. It felt like I smoked 2 packs of cigarettes or was on the verge of an asthma attack. Thursday - teeth less sensitive, lungs hurt but nothing as bad as Wednesday At 8:00pm found a golf ball size swollen lymph node on my left side where I got the vaccine. Also have a few swollen lymph nodes in my throat Friday (today) - swollen lymph node still present and large, Still having difficulty breathing.
29 2021-04-30 ringing in ears, ear discomfort Two weeks following the first vaccine dose, I felt light headed then full on vertigo, nausea, which ... Read more
Two weeks following the first vaccine dose, I felt light headed then full on vertigo, nausea, which lead to vomiting. My left ear feels full at times, both ears pop, and on occasion I experience ringing in one ear. The vertigo and instability is the most debilitating I have ever experienced. I have now felt this way for 8 days. My vision seems out of focus and doubles at times. Sudden turns and movements make the dizziness worse. I do still take Zofran for nausea though luckily I can keep food down. I am unable to drive and complete tasks at my job.
29 2021-05-01 deafness, visual impairment, ringing in ears Systemic: Bell's Palsy-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Tinnitus-Mild, Systemic:... Read more
Systemic: Bell's Palsy-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patietn recived the shot within 5 minutes blacked out not able to see by was still alert. Resolved with in 10min but emergency was call for further evaluation. Patient also reported issues with hearing and hot flashed. Was no signs of anaphylaxis.
29 2021-05-02 swelling around the eyes Puffy eyes; eye pain in lids. ? 12hrs Pain in chest. Pain inhaling to take deep breath. Strenuous ... Read more
Puffy eyes; eye pain in lids. ? 12hrs Pain in chest. Pain inhaling to take deep breath. Strenuous activity makes chest hurt more. Pain in left side of neck. Swollen lymph nodes.
29 2021-05-03 blindness Hurts to move her arm; Felt like she had the flu; Congestion; Headache; Tiredness; lymph nodes in he... Read more
Hurts to move her arm; Felt like she had the flu; Congestion; Headache; Tiredness; lymph nodes in her underarm area are swollen, really achy; lymph nodes in her underarm area are swollen, really achy; Chest pain; Numbness in her face; Completely lost her vision; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 (Batch/Lot Number: ER8729) as single dose for COVID-19 immunization. There were no medical history or concomitant medications. The patient experienced completely lost her vision on 12Apr2021 with outcome of recovered on 12Apr2021, congestion on 16Apr2021 with outcome of not recovered, chest pain on 12Apr2021 with outcome of recovered on 12Apr2021, numbness in her face on 12Apr2021 with outcome of recovered on 12Apr2021, felt like she had the flu on 17Apr2021 with outcome of recovering, lymph nodes in her underarm area are swollen, really achy on 13Apr2021 with outcome of not recovered, headache on 15Apr2021 with outcome of not recovered, tiredness on 13Apr2021 with outcome of not recovered, hurts to move her arm on an unspecified date with outcome of not recovered. lymph nodes in her underarm area are swollen, really achy was reported as worsened. Clinical course: the patient was asking for advice because she had the first dose of the Covid Vaccine 1 week ago and had a really bad reaction and had to go to the hospital. It has been a week now and the symptoms are continuously getting worse. It sounds like the side effects were all expected. She felt like she had the flu yesterday. She is really achy, her lymph nodes in her underarm area are really swollen, and it hurts to move her arm. She is familiar that these symptoms are expected, but it has been a week. She wants to know if she should see a physician or if there is something she should do. Event details: The flu like feeling was not until 6 days after she got the first shot. It is not as bad but she does have aches and congestion. Her lymph nodes are really swollen and she has a headache and tiredness. She had symptoms before, that was just the start of the flu like feeling. On the day of the shot she went to the hospital because she completely lost her vision and had chest pain. She got the shot on Monday, 12Apr2021. She had numbness in her face, vision loss, and chest pain. From there she went to the hospital and that subsided. It was just like total exhaustion and body aches for the next couple of days. She lost her vision for 5 minutes total. The numbness to her face was right after the shot and is all gone now. The achiness is pretty bad now. It differs per day but her symptoms have probably gotten a little worse as time has gone on. She had slight pain in her lymph nodes and they weren't really swollen. It got progressively worse to now they are very swollen and it hurts to move her arm. It was the same arm where the shot was given. The headache is off and on. It started around Thursday 15Apr2021. It is sporadic when she gets it. It hasn't gone away. The tiredness has been the same since she got the shot. When she went to the hospital she went to the ER. She was not admitted. She spent 4 to 5 hours there. Treatment: In the ER she just had an IV (intravenous). Other than that they did a bunch of lab work. She had no medicine or anything. Investigations: They did a chest X-ray and lab work in the ER. Emergency Room Visit required for events completely lost her vision, chest pain, numbness in her face, felt like she had the flu.
29 2021-05-05 dry mouth Patient report pain in upper right chest pointing with index finger 5 minutes after vaccination. Vit... Read more
Patient report pain in upper right chest pointing with index finger 5 minutes after vaccination. Vitals taken all normal. She requested sips of water. She reported delayed fever/chills then night of first dose with resolution. Experienced feeling cold/chills . moved to recovery bed and put on coat. temperature 96.3 F via infared thermometer. pain intensified radiating to back on same side. Pulse elevated 98. bp 130/78. diffculty swallowing due to pain with dry mouth. temp 97.8 F. pt request call 911 for transort to ER at 13:42. Continued pain with coughing. No longer cold now warm. Heart rate 100 temp 98.1 F. Onset of headache at 14:07 with dizzyness. Heart rate 113 Oxygen saturation 100%. EMS arrived 14:15 transported to Medical Center.
29 2021-05-06 loss of smell, loss of taste Headache Congestion or running nose New loss of taste or smell Dx Cough ? Shortness of Breath FATI... Read more
Headache Congestion or running nose New loss of taste or smell Dx Cough ? Shortness of Breath FATIGUE FEVER
29 2021-05-06 ear discomfort Fatigue, Headaches, and Congestion or runny nose - clear and also cloudy, head and ear pressure
29 2021-05-06 mouth itchiness, oropharyngeal discomfort, mouth tingling, swollen tongue, burning mouth syndrome, lip swelling swollen bottom lip; tongue ached; chest pains; itching in mouth after eating; swelling and tingling ... Read more
swollen bottom lip; tongue ached; chest pains; itching in mouth after eating; swelling and tingling tongue; swelling and tingling tongue; tight throat after eating; felt like mucus was in throat; enlarged thyroid; lightheadedness; ocular migraines; throbbing lymph nodes in throat; Discomfort in throat; skin itchy; This is a spontaneous report from a contactable consumer (patient). This 29-year-old female consumer (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot En 6506), on 24Feb2021 at 10:00 AM, in left arm, for COVID-19 immunisation. Medical history included benign thalaseemia, irritable bowel syndrome, ocular migraines, peanuts allergy, tree nuts allergy, penicillin allergy, amoxicillin allergy. Concomitant medications were none (no other medications in two weeks, no other vaccine in four weeks). Covid prior vaccination: no. On 26Feb2021 at 11:00, 48 hours post vaccine, the patient experienced itching in mouth after eating, swelling and tingling tongue, tight throat after eating, felt like mucus was in throat, enlarged thyroid. 2 weeks post vaccine, on an unspecified date in Mar2021, the patient experienced swollen bottom lip, tongue ached, chest pains. 4 weeks post vaccine, on an unspecified date in 2021, the patient experienced lightheadedness, ocular migraines, throbbing lymph nodes in throat. Discomfort in throat and skin itchy were also reported. The events resulted in Doctor or other healthcare professional office/clinic visit, disability or permanent damage. Allergist recommended antihistamines 2x per day. The patient had a negative nasal swab on 28Feb2021. The events had not yet resolved.
29 2021-05-08 sensitivity to light Sensitivity of vision to blue light and outside light. Headaches resulted from sensitivity to light.... Read more
Sensitivity of vision to blue light and outside light. Headaches resulted from sensitivity to light. Lasted 1-3 days. Wore reading glasses with blue light protection and took rest from screens. Anxiety increased during this time for 1-3 days.
29 2021-05-09 eye pain, mouth tingling, vision blurred Severe pain behind eyes, stiff neck/couldn?t turn head, severe head pressure and pain, pain that rad... Read more
Severe pain behind eyes, stiff neck/couldn?t turn head, severe head pressure and pain, pain that radiates from top of head down to shoulder, shakiness, swollen cheeks, red face with red marks, hot face, elevated blood pressure, swollen lymph nodes, seizing muscles, hazy vision, tingly mouth, dizziness, nausea, painful eyes, very painful neck and shoulders. All started immediately and worsened. Took weeks to subside
29 2021-05-10 pain in jaw, toothache, ear pain, ear infection, dry mouth I started with normal flu like symptoms for 3 days. Then after that I started having pain that seeme... Read more
I started with normal flu like symptoms for 3 days. Then after that I started having pain that seemed similar to a toothache/ear infection. As time went on it was getting worse and worse. I thought it was an ear infection and that it would go away on its own. On the week of 5/03/2021 it started becoming unbearable. I made an appointment to see the doctor to check out my ear. While at work on 5/10/2021 I started feeling like my blinking was off. I felt like my left side was slow and weak. By bedtime I was struggling to spit. I knew I had a doctor appointment in the morning so I decided to wait it out. By the time I got to my appointment most of the left side of my face was weak and not working properly. I also have severe pain in my ear and my jaw. I was diagnosed with Bells Palsy at the doctors office. He believes it is vaccine related. He gave me medication and suggested that I report this. He says that he expects a full recovery and very few people have permanent damage from this.
29 2021-05-11 taste impairment Metallic taste starting approximately 5 minute after vaccine. It has since lessened but not complete... Read more
Metallic taste starting approximately 5 minute after vaccine. It has since lessened but not completely gone.
29 2021-05-11 eye bleeding 5/11/2021 - 4 am - woke up with slight headache and extreme nausea 5:30 am - vomited and had painfu... Read more
5/11/2021 - 4 am - woke up with slight headache and extreme nausea 5:30 am - vomited and had painful back pain that radiated down through hips and thighs (could not lay still or get comfortable), fever of 101.9, had chills, took 2 Tylenol 10:30 am - at 3/4 piece of toast and sipped on 7up, fever of 101.2, had chills 11:00 am - vomited up toast and sprite. Headache was worse and made me dizzy. 12:00 pm - back, hips, and thighs were in pain and kept waking me up. Sitting up was hard and headache worse 2:00 pm - vomited water and then turned into stomach acid and then dry heaved (capillaries around eyes were busted and I have spots) fever 100.8
29 2021-05-11 lip swelling Lip swelling; throat swelling; This is a spontaneous report from a contactable consumer reporting fo... Read more
Lip swelling; throat swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number er8723 /expiration date: not provided), via an unspecified route of administration, on 27Mar2021 at 17:30 (at the age of 29 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included asthma, Triaminic allergy and requip allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included trazodone and alprazolam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Apr2021, one week after vaccine was given, the patient experienced lip swelling and throat swelling which required a physician's office visit. The patient received treatment for the events lip swelling and throat swelling which included prednisolone injection. The outcome of the events lip swelling and throat swelling was recovering. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : same patient, different vaccine dose/event
29 2021-05-11 taste disorder, taste impairment Metallic and floral taste to foods and some drinks. Ongoing even after 2nd dose of vaccine. It?s bee... Read more
Metallic and floral taste to foods and some drinks. Ongoing even after 2nd dose of vaccine. It?s been 5 1/2 weeks. 2 menstrual cycles missed.
29 2021-05-13 bleeding gums Headache, muscle ache, fever, gum bleeding, oral sore
29 2021-05-14 visual impairment A retinal vein occlusion, and I noticed right away; I scheduled an appointment with a retina special... Read more
A retinal vein occlusion, and I noticed right away; I scheduled an appointment with a retina specialist, and I was told I had a small blood clot in my right away; Exactly seven days after, something happened to my right eye that caused me issues with my vision.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 15Apr2021 18:15 (Batch/Lot Number: EW0162) as single dose for COVID-19 immunisation. Medical history included type 1 diabetes and thyroid issues, allergic to shellfish and to fluconazole. Concomitant medications included insulin and thyroid medication. Exactly seven days after (on 22Apr2021), something happened to patient's right eye that caused issues with her vision. Patient scheduled an appointment with a retina specialist and was told patient had a small blood clot in right away. A retinal vein occlusion and patient noticed right away because it was right in the middle of vision field/where the light enters through in the eye. Patient was type 1 diabetic with perfect control and patient had never had issues with vision (even got checked last year before COVID and no problems). Her endocrinologist did not think it was diabetes related either. The only different thing was the vaccine. Now patient was not sure if she should take the second dose and also her retina doctor wanted her to get checked for further blood clots to make sure she was okay. No treatment was received for the events. The events resulted in physician office visit and disability. Outcome of the events was not resolved.
29 2021-05-15 ear discomfort Ear throbbing and pressure, 24 hours on and off Fever(101-102.8), 48 hours on and off
29 2021-05-15 vision blurred I was driving when my vision in my right eye became blurry. The rightside on my body started to go t... Read more
I was driving when my vision in my right eye became blurry. The rightside on my body started to go tingly and then numb. As I was driving my vision got worse I was starting to barley be able to see out my eye. I also developed a severe headache on the right side of my body. I drove the the ER and go checked in because I thought I was having a stroke. I was immediately put on stroke alert.I feared for my life as my condition was worsening. I was rushed back to have a Cat scan after some initial test. Then two MRIs. One doctor said it was a result of the vaccine another said it wasn?t. After being observed for 10 hours I was discharged. My symptoms were almost gone at discharge. Six days later I begin that severe neck pain. Then a day after the initial neck pain it becomes unbearable. I got to my PCP where I am diagnosed with shingles. Ive never had shingles, ive never had anything like this. I am 100% pro vaccine but the hell this has put me through has been just awful.
29 2021-05-15 visual impairment Dizziness, fainting, brain fog, headache, not feeling like myself, cognitive delay, visual impairmen... Read more
Dizziness, fainting, brain fog, headache, not feeling like myself, cognitive delay, visual impairment. I?ve never had issues with my eyes or dizziness.
29 2021-05-17 mouth discomfort, tongue discomfort Pt experienced itchiness on chest and back approximately 5 minutes after receiving the vaccine, she ... Read more
Pt experienced itchiness on chest and back approximately 5 minutes after receiving the vaccine, she also noticed a rash on her chest. Lips started burning and tongue felt bigger about 15 minutes after inj. Face itchiness started about 40 after inj. Epi pen, Zyrtec, Benadryl, pepcid, dexamethasone, saline.
29 2021-05-17 smell distorsion Food aversion!!! Several foods I previously loved, now seem repulsive. I?m suddenly extra sensitive ... Read more
Food aversion!!! Several foods I previously loved, now seem repulsive. I?m suddenly extra sensitive to the smell, texture, and tastes of many foods (meat/chicken/pork, etc in particular). Sometimes I can?t even get my morning coffee down...usually I throw back multiple cups a day. A baked potato just made me gag. Even when I?m hungry, I?d rather not eat.
29 2021-05-17 thirst Guillain Barre Syndrome; nerve pain; legs were numb; woke up thirsty with her heart racing; woke up ... Read more
Guillain Barre Syndrome; nerve pain; legs were numb; woke up thirsty with her heart racing; woke up thirsty with her heart racing; she fell and had a urinary incontinence.; she fell and had a urinary incontinence.; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 07May2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection: Lot number: unknown), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient is a 29 year old female who received her 2nd dose of the Pfizer BioNTech COVID 19 Vaccine on 07May2021. It was reported that patient was admitted (hospitalized) on 08May2021 at around 5AM. As of 1:10AM today (12May2021), caller reported that the patient developed symptoms overnight. She reported nerve pain and that her legs were numb. She woke up thirsty with her heart racing and as she was getting water, she fell and had a urinary incontinence. Patient was diagnosed with Guillain Barre Syndrome, Vaccination Initial Encounter and was still hospitalized as of today. It was reported that the patient was uninsured and needs medical attention and physical therapy in order to return back home. The outcome of the events was unknown. Information on the lot/batch number has been requested.
29 2021-05-18 loss of taste This is a spontaneous report from a contactable other hcp. A 29-years-old non pregnant female patien... Read more
This is a spontaneous report from a contactable other hcp. A 29-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 22 Feb 2021 16:30 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient's vaccination history includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE on 01Feb2021. On 23Feb2021 12:00, the patient experienced loss/obscured sense of taste. The patient did not receive any treatment for the event. The patient was not tested positive for Covid prior and post vaccination. The outcome of the event was reported as not recovered. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
29 2021-05-18 mouth numbness 1/28/2021 at 1:30 I Started having a hard time swallowing, numbing of lips and tongue. Epinephrine, ... Read more
1/28/2021 at 1:30 I Started having a hard time swallowing, numbing of lips and tongue. Epinephrine, and Benadryl medication was given was kept under observation for 11-12 hours.
29 2021-05-19 eye strain, ear pain, mouth numbness About 2 days ago, patient started to feel numbness at the lips, uncontrollable eyelid movements, hea... Read more
About 2 days ago, patient started to feel numbness at the lips, uncontrollable eyelid movements, heaviness in eyeball, right ear pain and inability to raise right eyebrow. Patient said her PCP diagnosed the symptoms as Bell's palsy and prescribed meds for her. Patient did not provide name of meds to staff on-call. Patient was advised to follow-up with her PCP to assess if she should receive dose 2.
29 2021-05-19 blindness stroke-like symptoms; not being able to see out of my left eye; the left side of my body was numb; p... Read more
stroke-like symptoms; not being able to see out of my left eye; the left side of my body was numb; pounding headache on the left side of their head; shooting pain up and down my neck; could barely turn my head with shooting pain down my body; shingles; migraines; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 29 years of age), via an unspecified route of administration, administered in arm left on 22Apr2021 10:15 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included autoimmune disorder from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient had no known allergies. She was not diagnosed with COVID-19 prior to vaccination. She has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had stroke-like symptoms, not being able to see out of her left eye, the left side of her body was numb, and she a pounding headache on the left side of their head. Upon being checked into the ER, she was immediately put on stroke alert. After a CAT-Scan and two MRIs, blood clots were ruled out. She stayed under close watch, and an IV was administered. All her blood work numbers checked out and the doctors were puzzled. After three to four hours, the symptoms reduced. After ten hours, they were almost gone. She went home and didn't have any more complications that day. Fast forward to the 1st, new symptoms. She now has shooting pain up and down her neck. At first, she thought she strained her neck, but the next day she could barely turn her head with shooting pain down her body. This morning they went to their PPC to get checked out. Luckily, a diagnosis was given. She had developed shingles. The events started on 26Apr2021 10:00 AM. The events resulted to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for the events. Therapeutic measures were taken as a result of the events. She was given IV for migraines but it did nothing. The outcome of the events was recovered with lasting effects. Information on the lot/batch number has been requested.
29 2021-05-19 mouth tingling, lip swelling Pt complained of itching and redness of skin especially on chest and limbs approximately 12 minutes ... Read more
Pt complained of itching and redness of skin especially on chest and limbs approximately 12 minutes after injection at 1240 ( injection at 1227) although she states in the ED that the itching sensation started when she initially sat down. Zyrtec po was given at 1242 with initial improvement of rash but persistent itching of skin and scalp. Pt then noted lips were feeling swollen and tongue was tingling at 1250. Epi pen was given in right deltoid at 1255 and patient was moved to the ED, Room 4 for further monitoring, medications, and lab draws. At no time did patient experience wheezing or difficulty breathing. She did note rapid heart rate but denies syncope. Here in the ER, pt notes that the itching is improving but has not noticed a significant change in lip tingling. She does feel very shaky after the epi injection. Pt discharged to home/self care.
29 2021-05-19 tunnel vision The morning after my vaccine (5/18/2021), I woke up with a mild headache and achiness in my joints. ... Read more
The morning after my vaccine (5/18/2021), I woke up with a mild headache and achiness in my joints. I took ibuprofen to alleviate the pain and my headache came back later that afternoon. I started feeling nauseous in the evening before going to bed. The following morning (5/19/2021), I woke up with the same headache and was feeling nauseous still. After about an hour, I got out of bed thinking I was going to vomit. I was sitting on the bathroom floor and became lightheaded and my stomach started hurting worse. I got tunnel vision and passed out. My boyfriend was there and said that I started seizing for about 10 seconds and was cold. He said that I started to urinate and then regained consciousness after about 15 seconds. He called 911. I felt shaky and dizzy for about 15 min after. The ambulance showed up. My blood pressure was low, blood sugar was good, heart rate was good. I was able to walk to the ambulance and they took me to the ER. They gave me anti-nausea medication and fluids via IV. At the hospital, I received a CT scan for my head and another to check for clots in my lungs. Both tests came back negative. I had chills and body aches and was extremely tired. After about a couple of hours, I started feeling nauseous again and they gave me more anti-nausea medication. They did a urine sample and said I had a UTI, but other than that there was nothing wrong. They referred me to a neurologist to follow up about the seizure. They prescribed an antibiotic for the UTI and anti-nausea medication and I was discharged after about 5 hours.
29 2021-05-21 lip swelling Hives, facial swelling, muscular pain, lips swelling.
29 2021-05-22 extreme sound sensitivity, sensitivity to light Delayed menstruation by 7 days, causing severe menstruation pains (cramps) that have never been expe... Read more
Delayed menstruation by 7 days, causing severe menstruation pains (cramps) that have never been experienced in any prior menstruation (15 years). Menstruation has also been paired with a migraine (light and noise sensitivity, severe head pain) - I have NEVER experienced a migraine like this before (no history of having migranes).
29 2021-05-23 eye twitching, eye strain, swelling of eyelid After 2nd day with VAX i noticed my left eye twitching. It has been an almost constant twitch. My le... Read more
After 2nd day with VAX i noticed my left eye twitching. It has been an almost constant twitch. My left eye is swollen and feel like theis is liquid. My left eye feels strained
29 2021-05-23 conjunctivitis Got the vaccine, woke up 48 hours later with pink eye that can?t be linked elsewhere. It was a Sund... Read more
Got the vaccine, woke up 48 hours later with pink eye that can?t be linked elsewhere. It was a Sunday so I decided to wait until Monday to go to urgent care, and by Monday morning it was in both eyes. Prescribed erythromycin which seemed to clear it up.
29 2021-05-23 swollen tongue Pt came to desk stating felt like throat was "closing up and tongue swelling". Pt able to speak clea... Read more
Pt came to desk stating felt like throat was "closing up and tongue swelling". Pt able to speak clearly, no audible wheezing or stridor noted, denies difficulty breathing. Taken immediately to ED, placed into room, nurse with pt and report given, Dr. with pt. No overt signs of anaphylaxis, but discharged with steroids, epi-pen, and benadryl and consulted on returning if new, worsening, or concerning symptoms arise
29 2021-05-24 mouth tingling Tingling in mouth lips tongue, some trouble swallowing
29 2021-05-24 ringing in ears pulsatile tinnitus in left ear
29 2021-05-24 ringing in ears ringing in ears (constant and high pitched) headaches
29 2021-05-25 blindness Branch retinal artery occlusion (stroke) causing vision loss Currently taking aspirin and Lipitor ... Read more
Branch retinal artery occlusion (stroke) causing vision loss Currently taking aspirin and Lipitor as prophylactic measure while continuing to undergo extensive testing
29 2021-05-25 hearing loss, deafness, thirst Guillain Barre syndrome; could not walk/Can not walk/Unable to walk/not able to walk; have lost all... Read more
Guillain Barre syndrome; could not walk/Can not walk/Unable to walk/not able to walk; have lost all my movement of my leg and arm and my body/couldnt move my arms or anything; Cant do full movement on my arms or legs; Can't hear; cannot hear you properly; Can't hear properly, having a lot of issues with my ears; Lot of back pain/Back hurting; peed myself without knowing; peed myself without knowing, needed to get to the restroom. tried to get up and fell to the ground; Neck pain; feeling very thirsty; Chills; really bad headache; Now I could move my arm but they are still tingly and I feel sometimes really heavy; Now I could move my arm but they are still tingly and I feel sometimes really heavy; Arm and legs they are really numb; Williams-Beuren syndrome; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 at 08:30 (Batch/Lot Number: EW0171) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine includes bnt162b2 Dose 1 on 16Apr2021 Lot # ER8731. Anatomical site of injection: left arm. The patient experienced Guillain Barre syndrome, could not walk/Cannot walk/Unable to walk/not able to walk, lost all my movement of my leg and arm and my body/couldn't move my arms or anything; Can't do full movement on my arms or legs, Williams-Beuren syndrome, Arm and legs they are really numb, Now I could move my arm but they are still tingly and I feel sometimes really heavy on May2021; cannot hear you properly, can't hear, having a lot of issues, with my ears on an unspecified date; Chills, really bad headache on 07May2021; Lot of back pain/Back hurting, peed myself without knowing, needed to get to the restroom. tried to get up and fell to the ground, neck pain, feeling very thirsty on 08May2021. Therapeutic measures were taken as a result of Guillain barre syndrome (Guillain-Barre syndrome). The adverse events Movement disorder, unable to walk, Guillain-Barre Syndrome resulted in an emergency room visit and the patient was hospitalzied. Consumer Stated, She is receiving treatment (a lot of medication) but she does not know the name of the medications. Patient stated Part of my body they are improving but some other parts they are consistent. The patient reported she has had lost of lab tests but no additional information was provided The clinical outcome of the events was unknown. The clinical course was reported by the patient as follows The patient received the vaccine on 07May2021 on Friday at 8:30. A couples of hours after the vaccine the patient started with the headache. Around 8:30 at the night, she started with chills, she went to sleep and 1 o clock in the morning on Friday, woke up with the really bad headache and neck pain and my back hurting, She was feeling very thirsty. She got up from the bed to get the water and 'the movement that I made to get out of the bed' and peed herself without knowing, She needed to get to the restroom. She try to get up and fell to the ground. Her son helped her to get up again and in the bed. Consumer asked if being not able to walk that is one of the side effect. The patient called the hospital and went to the emergency room. When he got to the hospital she could not walk anymore. The caller stated she is presently in the hospital because she could not walk, lost all my movement of leg and arm and body and they told her that she had Guillain Barre syndrome after the administration of vaccine. Consumer also stated 'they told me that I had a Williams-Beuren syndrome after administration of vaccine' Consumer stated, I could not walk like for a whole day, right now I am getting off the bed but I cannot do full movement on my arms or legs and my doctor detected Guillain-Barre Syndrome after the administration of vaccine. Since that day the patient also reported she has had a lot of back pain and headache and arm and legs they are really numb and I could not move them, right now (at the time of the call) she could move my arm but they are still tingly and I feel sometimes really heavy but I can move them.' Caller mentioned she does not have medical insurance and inquired if Pfizer could do something like to help her to pay on for rehab.' Consumer stated they are sending her to rehab. Caller reported Some parts of my body have little improvement but some are the same. My arms I can move now, which I couldn't do before. The clinical outcome of the events was unknown.
29 2021-05-25 visual impairment Severe visual aura on left side obscuring vision. 2 days after vaccination. I had exactly the same s... Read more
Severe visual aura on left side obscuring vision. 2 days after vaccination. I had exactly the same symptoms after the first shot except 5 days later (first shot was 04/28/21 lot number EW-0172, migraine 05/03/21 around 6:30pm). That time the aura was worse and was accompanied by a very severe headache with nausea. Auras were abnormally severe in comparisons with those I had previously experienced.
29 2021-05-26 lacrimation increased Had fatigue and fever of 102 the two days immediately after the shot (somewhat expected). Starting o... Read more
Had fatigue and fever of 102 the two days immediately after the shot (somewhat expected). Starting on that Friday/Saturday April 30/May 1st started feeling allergic with watery eyes, runny nose, headache, extremely tired and low grade fever of 101 with GI issues. It's been almost 5 weeks now and I still have a low grade fever, consistently around 99.8 - 100.8. Today as of the time of this writing (5/27/21) my temp is 101.4. My normal/baseline temperature historically is around 98.5. Along with this consistent fever, I'm now experiencing random muscle spasms and nerve pain throughout my body, something I have never experienced before. This started 2 weeks ago with back pain that turned into roaming muscle/nerve spasms. Last week I started having abdominal pain that lasted for 3 days. Yesterday, the injection site on my right arm started throbbing and continued throbbing until this morning. I've seen a doctor and am having some tests done, but largely this remains a mystery. Before the 2nd shot I was fine, no fever, no muscle/nerve pain, and wasn't nearly as fatigued as I am now.
29 2021-05-30 loss of taste, loss of smell Prickliness and numbness in throat after 20 minutes, re-lost sense of taste and smell (had COVID 2 m... Read more
Prickliness and numbness in throat after 20 minutes, re-lost sense of taste and smell (had COVID 2 months prior and lost sense of taste and smell)
29 2021-05-30 ringing in ears, eye pain, vision blurred Starting on the day of the vaccine (2nd dose)- I felt really spacey, hallucinated at night and fever... Read more
Starting on the day of the vaccine (2nd dose)- I felt really spacey, hallucinated at night and fever. I took ibuprofen. I woke up the next day and noticed blurry vison in my left eye. Also had pain when moving the eye. I developed left sided weakness and notice declining cognitive functions. I felt extremely fatigue, difficulty swallowing, tinnitus, difficulty walking and my left leg was wek and my balance was definitely off. After about 2 weeks, I decided to go to the Hospital Emergency Room. I had an MRI with and without contrast and diagnosedwith optical neuritis. I saw opthamology on 2/9/2021 and they did all sorts of visual tests and referred me to neurology. I saw my PCP on 2/12/2021 and was referred to Neurology. I went to see a neurologist and was diagnosed with clinically isolated syndrome (precuror to multiple sclerosis) and had numerous MRI, blood work and EMG.
29 2021-06-01 ear pain, deafness, ringing in ears slight hearing loss; I've experienced ear pain; ringing in my ears; This is a spontaneous report fro... Read more
slight hearing loss; I've experienced ear pain; ringing in my ears; This is a spontaneous report from a contactable consumer who reported for herself that a 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-years, via an unspecified route of administration, administered in left arm on 14May2021 16:45 at single dose for COVID-19 immunisation, in pharmacy/drug store. Medical history included prior to vaccination, was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were reported as none. No other medications the patient received within 2 weeks of vaccination. On an unspecified date (reported as on 08May2021), the patient experienced ear pain and ringing in her ears and slight hearing loss. Outcome of the events was not recovered/not resolved. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained
29 2021-06-02 lacrimation increased, dry eye, eye movement disorder skin rash on both arms 5 minutes after vaccination, throat tightening sx's, globus sensation, headac... Read more
skin rash on both arms 5 minutes after vaccination, throat tightening sx's, globus sensation, headache and palpitations 5-15 minute after vaccine administration. 8 hours later, sensation of chest burning, throat burning and dyspnea; watery eyes and facial warmth. Associated facial erythema and eyes rolling in head X 5 minutes. Had alternating cold and warmth sensation - now still. Sx's continued - especially globus sensation. + abdominal pain continued for few days. One week later, patient with dyspnea. + eye dryness.
29 2021-06-02 tunnel vision I started to have tunnel vision and dizzy spells. I felt like I was losing focus and had bad headach... Read more
I started to have tunnel vision and dizzy spells. I felt like I was losing focus and had bad headaches. I went to the ER. I had a CT and blood work done. I had a lumbar puncture and the opening pressure was 29, which was above normal. I needed a blood patch four days later because I had a migraine that would not cease. On June 1st, I got another Lumbar puncture because I was having the same symptoms.
29 2021-06-03 conjunctivitis, bloodshot eyes Red Eyes Doctor treated me for pink I was given eye drops but it didn't work Went back to the Docto... Read more
Red Eyes Doctor treated me for pink I was given eye drops but it didn't work Went back to the Doctor, diagnosed as Conjunctivitis given eye drops and told to take Claritin and Zyrtec. Still isn't working my eyes are red now.
29 2021-06-03 ear pain, eye pain I had fever of 99° after taking ibuprofen 600 mg throughout the day on June 3. I had chills and swe... Read more
I had fever of 99° after taking ibuprofen 600 mg throughout the day on June 3. I had chills and sweats alternating from the evening and throughout the night. I woke up completely drenched in sweat I had to change my clothes. The chills were so severe that I could barely move (also because my bones hurt). All of this was over the course of approximately 6 PM until the next morning around 5 AM. More significantly, I experienced severe bone, joint and muscle aches all throughout my body. I had severe pain especially in my ankles, feet and knees. I also experienced pain in my spine, hands, arms, stomach, ears, and eyes. I felt mild nausea and a very mild headache. I am also nursing an infant, and my milk production was reduced from 30 ounces a day to approximately 15 ounces on the day of June 3.
29 2021-06-04 taste disorder, dry mouth Fever; Shivers; Tiredness; Dry mouth; Weird mouth taste and changes in flavor; Leg pain and cramps; ... Read more
Fever; Shivers; Tiredness; Dry mouth; Weird mouth taste and changes in flavor; Leg pain and cramps; Leg pain and cramps; Headache; General discomfort and skin hypersensitivity; General discomfort and skin hypersensitivity; Chest Pressure; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 29-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, in left arm on 25May2021 at 16:15 (at the age of 29-years-old) as 2nd dose, single for covid-19 immunization. The patient previously took the first dose of bnt162b2 (Lot number: EW0173) on 04May2021 at 04:30 PM (at the age of 29-years-old). Patient was allergic to Dewormers. The patient's concomitant medications were not reported. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25May2021, the patient experienced fever, shivers, tiredness, dry mouth, weird mouth taste and changes in flavor, leg pain and cramps, chest pressure, headache, general discomfort and skin hypersensitivity. No treatment was received by the patient. Outcome of the events was not recovered.
29 2021-06-07 loss of taste, loss of smell I had body aches, and I also became very fatigue. I ran a fever at 102 . I also lost my taste and sm... Read more
I had body aches, and I also became very fatigue. I ran a fever at 102 . I also lost my taste and smell. Two days later I test positive for COVID. A couple days later I recovered my taste from smell , but I am still having lingering affects with my taste and smell.
29 2021-06-08 ear pain Severe and unusual itchiness; Bruised; Severe itchy throat; Ears achiness; Soreness; Lethargic feeli... Read more
Severe and unusual itchiness; Bruised; Severe itchy throat; Ears achiness; Soreness; Lethargic feeling; This is a spontaneous report from a contactable consumer (patient herself). This 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly on the left arm on 06Mar2021 at 09:45 AM (Batch/Lot number EN6205) (at the age of 29-year old) at single dose for Covid-19 immunization. Relevant medical history included depression, polycystic ovarian syndrome (PCOS), food allergy to tree nuts, avocados, cantaloupe, sunflower seeds. Concomitant medications included bupropion, fluoxetine, spironolactone, cetirizine (ZYRTEC OTC). On 06Mar2021 at 11:00 AM the patient experienced severe and unusual itchiness, when scratched bruised immediately, severe itchy throat and ears achiness, soreness, lethargic feeling. The patient was treated with dyphenhydramine (BENADRYL), paracetamol (TYLENOL) and ibuprofen due to the events. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
29 2021-06-09 taste impairment, swollen tongue, dry mouth, mouth tingling Within 15 minutes of vaccine there was tingling sensation in the mouth. Within 40 minutes of the va... Read more
Within 15 minutes of vaccine there was tingling sensation in the mouth. Within 40 minutes of the vaccine there was tongue swelling, a metallic taste, and dry mouth. April 25, 2021 (10 a.m.) - Right half of face, right arm and right leg all went numb and tingly (Paresthesia). April 26, 2021 (evening) - slight shortness of breath, Dry mouth continued, sharp upper back pain April 28, 2021 (evening) - Shortness of breath, throat swelling, Dry mouth continued, sharp upper back pain. April 29th - Prescribed 40 mg of prednisone for 5 days (I felt good while on the prednisone), advair and albuterol May 4th - Symptoms returned after the prednisone dose was complete - On and off tingling/numbness of arms and right leg (Paresthesia), sharp pain in left calve and foot, shortness of breath, sharp back pain (upper), stomach pain (sharp), heart palpitations, dizzy, light headed. - These symptoms continue until present day (June 10, 2021). 21 Day dose of prednisone has been prescribed and a referral to a pulmonary doctor. June 10, 2021 - breath test came back abnormal indicating asthma -
29 2021-06-10 dry throat First shot: visible swelling in arm & painful to the touch. Swollen lymph nodes 5 hours after admini... Read more
First shot: visible swelling in arm & painful to the touch. Swollen lymph nodes 5 hours after administration of pfizer vaccine. Duration of about 2 days Second shot: slight arm stiffness after administration of pfizer vaccine. Around 4 PM throat became dry & scratchy. Around 5:30 sore throat. Duration is 3 days and counting.
29 2021-06-10 ear discomfort On May 24th developed fullness in Left ear, this was on/off for 2 weeks. On June 9 developed vertigo... Read more
On May 24th developed fullness in Left ear, this was on/off for 2 weeks. On June 9 developed vertigo, on may 10th developed left sided Bell's Palsy.
29 2021-06-13 lip swelling Chronic Hives. Lip Swelling ongoing issue since 1/29/2021.
29 2021-06-14 swelling of eyelid, eye swelling, lip swelling, mouth swelling 5/4-5/6: PRURITIC RASH DEVELOPED AT INJECTION SITE 5/7 - HIVES STARTED, TREATED WITH PREDISONE 50 mg... Read more
5/4-5/6: PRURITIC RASH DEVELOPED AT INJECTION SITE 5/7 - HIVES STARTED, TREATED WITH PREDISONE 50 mg qd x 5 days 5/8-5/10: HIVES, SWELLING ON UPPER & LOWER LIPS, SWELLING OF EYES 5/10 - HIVES, SWELLING OF EYES/MOUTH, SHORTNESS OF BREATH, TIGHTNESS AROUND CHEST; HIGH BLOOD PRESSUE,SWELLING IN POSTERIOR OROPHARYNX, SWELLING ON UPPER & LOWER LIPS, URTICARIA & MULTIPLE PAPULES ON BOTH ARMS, TORSO & BOTH LEGS -> WENT TO URGENT CARE WHERE WAS GIVEN AN EPIPEN THEN 911 CALLED &TAKEN TO THE HOSPITAL FOR FURTHER OBSERVATION OF ANAPHYLAXIS 5/11-5/15 - BRUISING; TAKING PREDISONE, BENADRYL, PEPCID AND CLARATIN. SYMPTOMS SUBSIDED DURING COURSE OF TREATMENT 5/26 - HIVES, SWELLING OF EYES/MOUTH, SHORTNESS OF BREATH, TIGHTNESS AROUND CHEST -> EPIPEN INJECTION ADMINISTERED 6/6 - HIVES AROUND ANKLE AREA AND SWOLLEN FEET/ANKLES 6/12 - WORST REACTION YET, HIVES, EYES SWOLLEN SHUT, SHORTNESS OF BREATH AND LIPS SWOLLEN -> EPIPEN INJECTION ADMINISTERED; LINGERING SIDE EFFECTS (SWOLLEN EYES, RASH HAVE NOT SUBSIDED COMPLETELY AS OF TODAY) - CONTINUING BANOPHREN AND CLARITIN TREATMENT DAILY
29 2021-06-16 double vision Pt. reports 15 minutes post vaccination experience double vision and tightness of the chest, causing... Read more
Pt. reports 15 minutes post vaccination experience double vision and tightness of the chest, causing it to be difficult to breath. This nurse was notified and vitals were 120/96, HR 110, O2 98. This nurse waited 5 minutes and took vitals again. They were - 120/88, HR 89, O2 99. After 15 additional minutes of patient resting on the cot, vitals were 118/20, HR81, and O2 99. Pt then began to be vomitous, experiencing increased chest tightness, and difficulty breathing. This nurse asked the pt if they would like to have EMS called and they obliged. Upon EMS arriving, pt vitals were stable and all tests done in the field came back WNL. Pt still wanted to be transferred to the nearest facility to be evaluated further. Pt. did state hx of elevated Red cell and was to follow up with PCP next week.
29 2021-06-16 taste impairment Developed headache 6/16/21 Developed metallic taste in mouth 6/17 Developed exhaustion 6/17 Vaccina... Read more
Developed headache 6/16/21 Developed metallic taste in mouth 6/17 Developed exhaustion 6/17 Vaccinated 6/15/21
29 2021-06-17 mouth tingling This is a spontaneous report from a non-contactable other healthcare professional (patient). A 29-ye... Read more
This is a spontaneous report from a non-contactable other healthcare professional (patient). A 29-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 07:45 (at the age of 29 years old) (Lot number was not reported) as first dose, single dose for COVID-19 immunization. The patient did not have COVID-19 prior to the vaccination. The patient was not pregnant at the time of vaccination. Medical history was reported as none. The patent had no known allergies. The patient did not take any other vaccine in four weeks. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported. On 03Feb2021 08:45 AM, the patient experienced tingling lips, flushing in face and heart palpitations. The events resulted in Emergency room/department or urgent care. No treatment was given for the events. The patient did not get a COVID test post vaccination. The outcome of the events was recovered in Feb 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
29 2021-06-17 visual field defect Cotton wool spots prolimission; scotoma OS; This is a spontaneous report from a contactable physicia... Read more
Cotton wool spots prolimission; scotoma OS; This is a spontaneous report from a contactable physician. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: EW0167), dose 2, intramuscularly on 06May2021 (at the age of 29-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history was not reported. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; clonazepam (CLONAZEPAM) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot number: EW0162), dose 1, intramuscularly on 15Apr2021 as 1ST DOSE, SINGLE for COVID-19 immunization and experienced retinal vein occlusion, ocular vascular disorder, visual impairment, retinal exudates and visual field defect on 26Apr2021. On 18May2021, the patient experienced cotton wool spots prolimission and scotoma OS. The adverse events required a visit to the physician's office. The events were assessed as serious (important medical events). It was unknown if any treatment was received. Clinical outcome of the events was not resolved. Follow-up actions are needed. Further information has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-06-18 mouth numbness, eyelid function disorder Eyelid won't close all the way and left side of mouth is numb/not moving. Possibly Bell's Palsy; Eye... Read more
Eyelid won't close all the way and left side of mouth is numb/not moving. Possibly Bell's Palsy; Eyelid won't close all the way and left side of mouth is numb/not moving. Possibly Bell's Palsy; Eyelid won't close all the way and left side of mouth is numb/not moving. Possibly Bell's Palsy; Eyelid won't close all the way and left side of mouth is numb/not moving. Possibly Bell's Palsy; Eyelid won't close all the way and left side of mouth is numb/not moving. Possibly Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 22Mar2021 (Batch/Lot Number: EW0161) at the age of 29 years old, as 2ND DOSE,SINGLE for covid-19 immunisation. Patient received the first dose on 22Mar2021 at the age of 29 years old (lot number: ER8730). The patient medical history was not reported. Concomitant medications included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and sunflower lecithin. The patient experienced mild facial numbness on the left side. Eyelid won't close all the way and left side of mouth is numb/not moving. Possibly Bell's Palsy on 03Jun2021 13:30. Ae resulted in: [Doctor or other healthcare professional office/clinic visit]. Outcome of events was Not recovered.
29 2021-06-20 deafness, sensitivity to light, ringing in ears Yesterday evening I experienced three episodes of hearing loss/ringing in my left ear. The longest e... Read more
Yesterday evening I experienced three episodes of hearing loss/ringing in my left ear. The longest episode lasted for probably about a minute (which is way longer than I've ever experienced before). After the hearing loss, I noticed my eyes became a little more sensitive to light and I felt dizzy and a pressure/tickle sensation in my head which then became more focused towards the back of my left eyeball and a little of the back of my left upper arm & left wrist (very strange). No pain or numbness. I wouldn't describe it as tingle as it was more of tickle. Hearing has not gone out again since last night but I have some constant ringing/tinnitus and still feel tickle sensation in my left arm and behind left eye. I couldn?t find much about the tickle online but came across a user who had COVID who literally described a ?ticklish pressure? in their ear, so I know I can?t be the only one to have noticed this!!!
29 2021-06-20 burning mouth syndrome, swollen tongue Starting having tongue pain and swelling 2 days after second vaccine shot, felt like my throat was s... Read more
Starting having tongue pain and swelling 2 days after second vaccine shot, felt like my throat was swelling up as well. Have been diagnosed with geographic tongue, which there is no cure for. Its been 3 weeks and my symptoms have not improved.
29 2021-06-23 sensitivity to light Patient experienced a thunderclap headache during a workout at about 6:00pm on 05/05/2021. She also ... Read more
Patient experienced a thunderclap headache during a workout at about 6:00pm on 05/05/2021. She also had nausea, light sensitivity, and neck stiffness. She went to urgent care around 8:00pm and received a shot of toradol for suspected migraine. When the headache didn't resolve completely, she went to the emergency room around 11pm. On 05/06 around 5:30am, a CT scan revealed a subarachnoid hemorrhage over the right sylvian fissure. A CTA of the head and neck immediately following showed no aneurysm or AVM. The patient was admitted, and underwent a catheter angiogram later that afternoon, which also showed no aneurysm or AVM. She was admitted to the NeuroICU for one week, took nimodipine and keppra as prescribed, underwent transcranial dopplers daily to check for vasospasm, and did not develop any major complications. Patient developed worsening pain near the tailbone while hospitalized, which was attributed to nerve pain from blood in the subarachnoid space. On 05/12/2021, the patient underwent a second catheter angiogram, which also showed no aneurysm, AVM, or abnormality. The patient was discharged home on 05/13/2021, with followup with neurosurgeon for a likely third cerebral catheter angiogram.
29 2021-06-28 ringing in ears I recived the first does of Covid 19 vaccine Pfizer-BioNtech on June 28, 2021 around 2:30 in the aft... Read more
I recived the first does of Covid 19 vaccine Pfizer-BioNtech on June 28, 2021 around 2:30 in the afternoon. I felt fine for the most part the rest of the day, just a little pain in my arm and a slight headache. I went to bed and woke up at 5:50 am on June 29, 2021. I went to the bathroom and started to overheat and my ears started ringing, then I blacked out and fainted. I woke up on laying on the bathroom floor.
29 2021-06-29 loss of smell Losing smell; This is a spontaneous report received from a contactable consumer, the patient. A 29-y... Read more
Losing smell; This is a spontaneous report received from a contactable consumer, the patient. A 29-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep7534,) via an unspecified route of administration in the left arm on 19Mar2021 at 12:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Mar2021 at 21:00, the patient was losing smell. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 20Mar2021 which included nasal swab and the test result was negative. The patient did not receive any treatment for the event losing smell. The clinical outcome of the event losing smell was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
29 2021-06-29 taste impairment Intense metallic taste in mouth; This is a spontaneous report received from a contactable consumer, ... Read more
Intense metallic taste in mouth; This is a spontaneous report received from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the right arm on 20Mar2021 at 13:30 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included etonogestrel; ethinyl estradiol (NUVARING) for an unknown indication on an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Mar2021 at 14:00, the patient experienced intense metallic taste in mouth. The patient did not receive treatment for the event intense metallic taste in mouth. The clinical outcome of the event intense metallic taste in mouth was not recovered. No follow-up attempts are needed. No further information is expected.
29 2021-06-30 canker sore This is a spontaneous report from a contactable other nurse (patient). A 29-years-old non-pregnant f... Read more
This is a spontaneous report from a contactable other nurse (patient). A 29-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6206), via an unspecified route of administration in Arm Left on 11Mar2021 at 14:45 (29-years-old at the time of vaccination) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in Mar2021, the patient experienced swollen lymph nodes hours after COVID-19 vaccine, then fever and next day developed aphthous ulcers in mouth and tongue. She also developed a strep throat infection and cold sores on lower lip, it's been a week and she still have the cold sores on her lip that became infected. She hasn't been able to eat well due to the pain she was currently experiencing. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown if patient tested for COVID-19. The outcome of events was not resolved. Follow-up attempts are needed. Information Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event bacterial pharyngitis, Lymphadenopathy, Asthenia and Pain with the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
29 2021-06-30 ear pain, ear discomfort, ringing in ears Dizziness, Unilateral Left side migraines, Ear pain, ear pressure all started March 8th and have bec... Read more
Dizziness, Unilateral Left side migraines, Ear pain, ear pressure all started March 8th and have become increasingly worse, have not been resolved with medications & I am now experiencing new symptoms of tinnitus. Doctors have not suggested treatments beyond medications and are dismissive to finding the cause of these sudden symptoms. I have been seeing my PCP and have seen a Neurologist and ENT. My recent visit was with Dr. who has exhausted all possibilities and is now having to refer me to Clinic. Since my symptoms have not improved, this now affecting my day to day activities and life, I have not been able to work since 4/21/2021 after having to be in the ER due to severity of dizziness.
29 2021-06-30 lip pain, bleeding gums Early AM 6/16/21: I began noticing petechia on my feet. A bloody sore developed on my lip and my mou... Read more
Early AM 6/16/21: I began noticing petechia on my feet. A bloody sore developed on my lip and my mouth was bleeding a little. Late afternoon 6/16/21: The petechia moved up my legs and the bleeding in my mouth hadn't stopped. I was incredibly tired. 6/17/21: The bleeding in mouth worsened. I was having to walk around with gauze in my mouth to control the gum bleeding. More big, black, bloody sores developed in my mouth. The petechia was now covering most my body, including inside my ears and mouth. 6/18/21: I was no longer able to eat without sever pain. I was bleeding profusely when I urinated. Petechia had moved into my eyes. I was incredibly fatigued and I had a migraine that was progressively getting worse over the past 3 days. My mother rushed me to the ER at noon. I was admitted to the hospital within 30 minutes of arriving. They began running tests immediately. I lost track of the amount of blood they took to test. I received a CT Scan and MRI to ensure I wasn't bleeding from my brain or had a stroke. By 7:30PM I was in the main hospital. I was given a COVID test at this time. They informed me that my platelet count had dropped to 5,000 and they would be giving me bagged platelets(1 bag) and IVIG (8 glass bottles). 6/19/21: I was woken up around 6:30AM and given a dose of Dexamethasone and B12. They drew more blood a couple hours later. By noon the doctor informed me that my platelet count had increased to 9,000. That evening I had another dose of 7 glass bottles of IVIG. 6/20/21:I was woken up around 6:30AM and given a dose of Dexamethasone and B12. They drew more blood a couple hours later. By noon the doctor informed me that my platelet count had increased to 125,000. 6/21/21: I was released from the hospital due to my platelet count continuing to go up. It was up to 400,000. I was given a prescription for one more dose of Dexamethasone, Sumatriptan for my migraines and told to continue taking B12. 7/1/21: Had a follow up appointment with the hematologist from the hospital and I was informed my platelet count was okay but that I am now anemic.
29 2021-07-01 thirst, mouth tingling, lip swelling, lip dry, dry mouth, feeling of choking felt like dry lips; Dry mouth; Really thirsty; top lip was swollen; lips, tip of nose, and throat fe... Read more
felt like dry lips; Dry mouth; Really thirsty; top lip was swollen; lips, tip of nose, and throat feel tingly now; felt tingly and dry underneath my lip; throat feel tingly; soreness on my arm; tightness on my chest with difficulty breathing; tightness on my chest with difficulty breathing; my mind was foggy.; it was hard for me to walk and I was incredibly tired; massive headache on my forehead; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other medications within 2 weeks of vaccination. On 20Mar2021 at 10:00 approx. 20 seconds after the vaccine, the patient experienced massive headache on her forehead, shortly after that felt like a huge load was pushing her back into her seat. The patient wasn't able to keep conversations and her mind was foggy. It was hard for her to walk and she was incredibly tired. She slept most of the afternoon. At night before going to bed (at 21:00), she had a tightness on her chest with difficulty breathing and this was on Saturday. On 21Mar2021 (Sunday), all she had was soreness on her arm. On 23Mar2021 (Tuesday), she woke up around 4:10 with a dry mouth and what felt like dry lips. She was really thirsty and grabbed a cup of water and used the restroom. When she was washing my hands, she saw her face and noticed the top lip was swollen. It was so big that it overlapped her bottom lip. She felt tingly and dry underneath the lip. The patient continued to drink water and the swelling decreased not completely but it did go down. On 23Mar2021 at 09:07, the swelling decreased. The patient reported that the lips, tip of nose, and throat felt tingly now. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events forehead headache, foggy feeling in head, tiredness, chest tightness, difficulty breathing, pain in arm, dry mouth, dry lips, thirst, swollen lips, tingling lips, tingling and tingling throat. The clinical outcome of the event swollen lips was recovering while that of forehead headache, foggy feeling in head, tiredness, chest tightness, difficulty breathing, pain in arm, dry mouth, dry lips, thirst, tingling lips, tingling and tingling throat was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
29 2021-07-01 vision blurred, tunnel vision At vaccine site I experienced an acute event of shortness of breathe, tunnel/blurred vision, heart p... Read more
At vaccine site I experienced an acute event of shortness of breathe, tunnel/blurred vision, heart palpitations, increased heart rate, brain fog. Had 9 episodes since then. Three days after I had an ER visit, no diagnosis. Given EpiPen and muscle relaxers. Occasional chest pain, tightness in chest and neck. difficult to sallow. Very short winded, shortness of breathe. Currently on heart monitor.
29 2021-07-05 swollen gums I'm not sure about anatomy and where or if there are lymph nodes in the head; lump behind her left e... Read more
I'm not sure about anatomy and where or if there are lymph nodes in the head; lump behind her left ear which was measured to be 1 inch in length and a 1/2 inch in width and another lump on her head under her hair so it was difficult to visualize; had issues swallowing; her gums were swollen; Potentially a lymph node that got inflamed; This is a spontaneous report from a contactable Pharmacist via Medical Information Team. A 29-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number: ew0191 and expiration date: sep2021) via intramuscular route of administration at left deltoid on 05Jun2021 14:30 (at the age of 29-year-old) as dose 1 single for COVID-19 immunisation. Patient medical history and Concomitant medications were not reported. On an unspecified date patient experienced a lump behind her left ear which was measured to be 1 inch in length and a 1/2 inch in width and another lump on her head under her hair, so it was difficult to visualize. The caller reports that initially when the lump showed up it was not bothering her but now the patient sates that it was. initially after receiving the vaccine, had issues swallowing and her gums were swollen and Potentially a lymph node that got inflamed and patient was not sure about anatomy and where or if there are lymph nodes in the head. Outcome of the events was had issues swallowing and her gums were swollen was recovered on an unknown date and rest all the events were not recovered. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of lymphoma cannot be excluded . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-07-05 mouth pain, pain in jaw On reported date 2/9/2021, I started having idiopathic pain in my lower left jaw, this pain slowly i... Read more
On reported date 2/9/2021, I started having idiopathic pain in my lower left jaw, this pain slowly increased and spread to entire left side of mouth and into the left cheek. Within three days, I had trigeminal neuralgia pain shooting through my left cheek, left side of jaw as well as over my left eye.
29 2021-07-05 ringing in ears, sensitivity to light I've never experienced sudden hearing loss as frequently or tha's lasted as long as it has now.; It ... Read more
I've never experienced sudden hearing loss as frequently or tha's lasted as long as it has now.; It gets muted and starts ringing; Eyes became a little more sensitive to light; I felt slightly dizzy; A pressure/tickle sensation in my head; I wouldn't describe it as tingle as it was more of a tickle back of my left eyeball and a little of the back of my left upper arm & left wrist; This is a spontaneous report from a contactable other HCP (patient). A 29-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 11Jun2021 as dose 1 single (at the age of 29-year-old) for COVID-19 immunization at Pharmacy or Drug Store. Medical history was not reported. Patient previously took sulfa product used for unknown indication and experienced drug allergy. Concomitant medications within 2 weeks of vaccination included bupropion hydrochloride (WELLBUTRIN), vitamins nos (MULTIVITAMIN [VITAMINS NOS]). Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jun2021, patient hearing had been going out intermittently in her left ear. Specifically, this past time it went out twice in 10 min and the second time it lasted for about a whole minute. It gets muted and starts ringing. She knew Wellbutrin had tinnitus as a side effect, but she had been on Wellbutrin for years with no changes in her dose. She had never experienced sudden hearing loss as frequently or that's lasted as long as it has now. This evening on 20Jun2021, experienced three episodes of hearing loss/ringing in my left ear. The longest episode lasted for probably about a minute (which is way longer than she had ever experienced before). After the hearing loss, she noticed her eyes became a little more sensitive to light and she felt slightly dizzy and a pressure/tickle sensation in her head which then became more focused towards the back of my left eyeball and a little of the back of my left upper arm & left wrist (very strange). No pain or numbness. She would not describe it as tingle as it was more of a tickle. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the adverse events. The outcome of the events was not recovered. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Deafness transitory and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
29 2021-07-06 blindness The day after the vaccine I had a bad migraine with aura (vision loss) lasting for several hours tha... Read more
The day after the vaccine I had a bad migraine with aura (vision loss) lasting for several hours that was atypical for me. I have had migraines with aura before but not like this.
29 2021-07-07 vision blurred During observation, pt reported blurry vision and numbness to both arms. Adult emergency called and ... Read more
During observation, pt reported blurry vision and numbness to both arms. Adult emergency called and transported to hospital for eval.
29 2021-07-08 swollen tongue Itchy throat; Swollen tongue; This is a spontaneous report from a non-contactable consumer or other ... Read more
Itchy throat; Swollen tongue; This is a spontaneous report from a non-contactable consumer or other non hcp. A 29-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as (at the age of 29 years) DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation the patient was not diagnosed and didn't get tested with COVID-19 prior to vaccination. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced itchy throat, swollen tongue patient did not had emergency room visit or physician office for these events. The outcome of the events throat irritation, swollen tongue was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information Final sentence "Information about lot/batch number cannot be obtained. No further information is expected." updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained." Initial information need review for adverse events Itchy throat, swollen tongue. Outcome of the events was reported as unknown, patient did not received any treatment for the adverse events.
29 2021-07-13 drooling The first day, I noticed a lot of saliva passing through my throat and then it went away. I also not... Read more
The first day, I noticed a lot of saliva passing through my throat and then it went away. I also noticed a lot of exhaustion days later and throughout the whole month. After my second dose, I noticed I started having edema. I struggled with that for about a month. Then I ended up being diagnosed with nephrotic syndrome, minimal change disease and acute kidney injury. The cause was pretty much unknown. I don't have a history or kidney disease or anything like that.
29 2021-07-14 photosensitivity reaction I developed a sun allergy - it started out as itchy red rash and developed to Hives. I contacted Der... Read more
I developed a sun allergy - it started out as itchy red rash and developed to Hives. I contacted Dermatologist (a friend who lives out of the country - informal doctor visit)- He prescribed Allegra 10 days; Hydrocortisone cream and some Aloe Vera gel. It took about 5-6 days, then they subsided. But even now when I go back into the sun, I still have the symptoms reappear and I still get itchy. They aren't as bad as they were the first time but I still get itchy and the red rash appears.
29 2021-07-15 swollen tongue Felt like allergies with a sore throat and stuffy nose on Saturday afternoon. After dinner time I fe... Read more
Felt like allergies with a sore throat and stuffy nose on Saturday afternoon. After dinner time I felt that my left neck lymph node swelling started and my tongue also gelt swollen. I had pain in both of my underarms that had started on the left underarm and had lasted around 4 days.
29 2021-07-17 loss of taste, loss of smell Tested positive for COVID; Lost sense of taste and smell; Lost sense of taste and smell; Congestion;... Read more
Tested positive for COVID; Lost sense of taste and smell; Lost sense of taste and smell; Congestion; Dry cough; This is a spontaneous report from a contactable consumer or other non hcp. A 29-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via intramuscular route, administered in Arm Left on 17Mar2021 (Batch/Lot Number: EN6206; Expiration Date: 30Jun2021) as DOSE UNKNOWN, 0.3ml SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Received call from consumer regarding the Pfizer COVID vaccine. He would like to speak with someone about the effects he had, and any suggestions Pfizer may have to help him. While reporting side effects for himself, he mentioned that his wife, son and daughter, all had side effects after receiving the vaccine. father of patient handed phone to his daughter after he reported for himself. His daughter came on the line and reported on behalf of herself that, she tested positive for COVID on 22 Monday, 22Mar2021, but did not get results until yesterday 25Mar2021. This occurred after she got the vaccine. On 20Mar2021, the patient had cough, on 21Mar2021, the patient had congestion and on 22Mar2021, the patient had Lost sense of taste and smell. The patient underwent lab tests and procedures which included sars-cov-2 antibody test positive: positive on 22Mar2021. Product quality complaint was recorded for compound BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 (not clear after first shot or second Covid positive). The clinical outcome of the events (at the time of report was) Lost sense of taste and smell was not recovered, Congestion, dry cough was recovering, tested positive for COVID was unknown. No follow-up attempts are possible; No further information is expected.
29 2021-07-17 taste impairment Metallic taste in mouth after injection; Left side of face was tingling; This is a spontaneous repor... Read more
Metallic taste in mouth after injection; Left side of face was tingling; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 21Mar2021 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to kiwi. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021, the patient had experienced a metallic taste in mouth after injection and left side of face was tingling. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events metallic taste in mouth after injection and left side of face was tingling was resolved on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.
29 2021-07-17 lip swelling Immediate allergic reaction after vaccine; lip swelling; swollen lymph node under chin/lymph node un... Read more
Immediate allergic reaction after vaccine; lip swelling; swollen lymph node under chin/lymph node under left armpit was extremely swollen, formed a large bump and was still swollen; hard to swallow; racing heart; lymph node under left armpit was extremely swollen, formed a large bump and was still swollen and tender 3 days later; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 26Feb2021 18:45 (at the age of 29-year-old, Batch/Lot Number: EN6202) at arm left as single dose for COVID-19 immunisation. The patient previously took minocycline and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with or tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications taken in two weeks included: ashwaganda gummies and botulinum toxin type A (BOTOX) for forehead 1 week prior. The patient experienced immediate allergic reaction after vaccine including lip swelling, swollen lymph node under chin, hard to swallow, racing heart. Next day lymph node under left armpit was extremely swollen, formed a large bump and was still swollen and tender 3 days later. All events started on 05Mar2021 18:15 (as reported, pending clarification) and were serious due to medically significant. The events resulted in doctor or other healthcare professional office/clinic visit. Diphenhydramine hydrochloride (BENADRYL) taken as treatment. The patient received second dose of BNT162B2 on 19Mar2021 18:15 (at the age of 29-year-old, Batch/Lot Number: EN6207) at arm left as single dose. The outcome of all the events was not recovered. Follow-up attempts are possible. Further information is expected.
29 2021-07-19 eye irritation, lacrimation increased, eye itchiness Pt reported back to pharmacy ~15 mins after shot complaining of eye burning, watering and itching. B... Read more
Pt reported back to pharmacy ~15 mins after shot complaining of eye burning, watering and itching. Bilateral itching on arms. No impact on breathing/chest. Administered 50mg Benadryl and pt sat for 15 more additional minutes. Left on their own and stated symptoms were improving. Advised to stay in store a bit longer just in case. Will f/u in 3 days. Shot 1. Advise caution with shot 2.
29 2021-07-20 sensitivity to light, vision blurred Lymph nodes were swollen for the past 5 days; Vision was blurry and light was bothering her; Heart r... Read more
Lymph nodes were swollen for the past 5 days; Vision was blurry and light was bothering her; Heart racing; Hard to breathe; She got a fever of 100.1; Chills; Tired even after getting a full 8 hours sleep/refused to get off the couch for the past seven days; Joint pain in her knees back and shoulders; She was vomiting three times since she got the injection; Headache, like an extreme migraine/headache is worse; She couldn't eat and refused to get of the couch for the past seven days; Heart Racing; Feels like an anxiety attack; Last night she could feel her heartbeat in her feet and hands; She says it feels like there is an elephant on her shoulders; refused to get of the couch for the past seven days; her blood pressure and he is guessing it was about 152/90; tenderness at injection site; Vision was blurry and light was bothering her; swelling and redness at the injection site; swelling and redness at the injection site; This is a spontaneous report from a contactable consumer reported for 29-years-old female patient (reporter's fiancé). This consumer reported different events for two patients. This is 2 of 2 reports. A 29-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, (Batch/Lot number: not reported; Expiration date: UNKNOWN) in left arm via an unknown route of administration, administered in the left arm on 29Apr2021 09:30 (at the age of 29-years-old) as dose 2, single for COVID-19 immunisation. (Reason for no lot number: of Pfizer COVID 19 vaccine: Other: Caller does not have vaccination card; no lot number). Medical history included thyroid disorder on 2013 (From eight years ago). No prior vaccinations were done within 4 weeks. And they think Patient needs glasses, because she has problems seeing at night. All of this all happened before the vaccine. Checked for COVID19 twice JUN2020 through JAN2021 and this was negative. The patient's concomitant medications were not reported. Family History: none. The patient previously received the first dose of bnt162b2 (BNT162B2, solution for injection, (Batch/Lot number: not reported) in left arm via an unknown route of administration on 22 days prior on 07Apr2021 at 09:30am in left arm as dose 1, single for covid-19 immunisation and experienced fever of 100.3F within 12 hours of having the vaccine the first time, unwell causing blurred vision, nausea from extreme headache comparative to a massive migraine, muscle pains and chills, fast heartbeat then the nigh, heart rate is 128 bpm-132 bpm, dizziness and weakness that lasted for 5 days. It was reported that after the second dose patient had everything on 29Apr2021. The reporter clarified that first she (patient) thought she had a cold, so he looked at her and found swollen lymph nodes; she got a fever of 100.1; chills; tired even after getting a full 8 hours sleep; tenderness at injection site; joint pain in her knees back and shoulders. She took that day of the vaccination off. She was vomiting three times since she got the injection, and again today at work. She complained of a headache, like an extreme migraine, like a hammer hitting her head and it is getting worse everyday. She noticed her vision was blurry and light was bothering her. She couldn't eat and refused to get of the couch for the past seven days. He took her blood pressure and he is guessing it was about 152/90. At night she feels her heart racing; she can't relax, it feels like an anxiety attack and she never has that. Mentioned, last night she could feel her heartbeat in her feet and hands; she says it is hard to breathe. Adds she just texted him hour ago she was going to talk to her direct boss, because she threw up today at work and she still has the headache; and she says it feels like there is an elephant on her shoulders it is hard to breathe. Today she has no fever and her heart rate was fine at 65 beats per minute. But nothing has changed. All of her symptoms are persisting and the headache is worse. Adds at night her heart rate was 130 beats per minute just laying in bed. The adverse events did not require a visit to the Emergency Room/ Physician Office. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative in Jun2020, sars cov-2 test negative in Jan2021; Blood pressure 152/90 (units not reported); body temperature was 100.1 on on 29Apr2021; Heart rate (65 beats per minute/ 130 beats per minute). Clinical outcome of the event Fever recovered on an unspecified date in April 2021; outcome of the event Vaccination site swelling was unknown; outcome of the other events had not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
29 2021-07-22 ear pain Lightheaded; Severe upper abdominal pain; Ear pain; Nausea; Joint pain; This is a spontaneous report... Read more
Lightheaded; Severe upper abdominal pain; Ear pain; Nausea; Joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Apr2021 at 11:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included post-traumatic stress disorder (PTSD), unknown pain disorder, asthma. The patient's drug and vaccine allergy included allergy to influenza vaccine (MANUFACTURER UNKNOWN), naproxen (MANUFACTURER UNKNOWN), dicloxacillin (MANUFACTURER UNKNOWN), CEPHALEXIN, omeprazole (PRILOSEC), etonogestrel (NEXPLANON), bupropion hydrochloride (WELLBUTRIN XL), metoclopramide (REGLAN) and pregabalin (LYRICA). Concomitant medications included paracetamol (TYLENOL) and acetylsalicylic acid, caffeine, cinnamedrine (MIDOL) for unknown indication from an unknown date. The patient also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 17:00, the patient experienced light-headedness, severe upper abdominal pain, ear pain, nausea and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. It was unknown if therapeutic measures were taken as a result of adverse events. The clinical outcome of the events lightheaded, upper abdominal pain, ear pain, nausea and joint pain was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
29 2021-07-22 eye pain, sensitivity to light Upper arm pain (same as injection arm, 4/10) Reduced arm motion (cannot reach past 90 deg angle) Sli... Read more
Upper arm pain (same as injection arm, 4/10) Reduced arm motion (cannot reach past 90 deg angle) Slight, low-grade fever Increased headache Light sensitivity (did not have pre-injection) Eye pain (2/10) Mucus at back of throat
29 2021-07-22 ringing in ears Pt reported tinnitus starting approximately a week after her first pfizer dose. She went to an audio... Read more
Pt reported tinnitus starting approximately a week after her first pfizer dose. She went to an audiologist and had her ears checked and everything came back normal. Pt reports the tinnitus is still occurring intermittently about a month later.
29 2021-07-23 taste impairment face started hives; Chest started getting tight; heart rate started elevating; face started burning;... Read more
face started hives; Chest started getting tight; heart rate started elevating; face started burning; started wheezing; started coughing; begging to not breath; Weird taste in mouth; itching all over; whole body was sore; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received BNT162B2 (Lot Number: Ewd171), dose 1 via an unspecified route of administration, administered in arm right on 10Jul2021 11:00 at the age of 29-year-old as single dose for covid-19 immunisation. Medical history included asthma. No known allergies. The patient's concomitant medications were none. The patient experienced adverse events on 10Jul2021 at 11:30. Reported Event: Weird taste in mouth, face started hives, chest started getting tight, heart rate started elevating, face started burning. The patient started wheezing then she started coughing she begging to not breath. The patient grabbed her inhaler and took the first pump it did not work, she took another pump it did not work, she took 2 more no luck, 2 more some luck, ambulance assisted. Hour later her whole body was broken out, her chest tight itching all over bumps everywhere, she was wheezing, her whole body was sore and she did not feel good. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included nasal swab for Covid-19: negative on 08Jul2021. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.
29 2021-07-25 swollen tongue the sensation of swelling of posterior tongue and lower pharynx swelling like an allergic reaction b... Read more
the sensation of swelling of posterior tongue and lower pharynx swelling like an allergic reaction but tongue not visibly swollen about 30 minutes after administration of 1st dose. Took oral anti-histamine, and symptoms resolved after 1 hour.
29 2021-07-27 swollen tongue, swelling around the eyes Patient described ~3-4 hours after receiving her shot that she experienced swelling behind her eyes... Read more
Patient described ~3-4 hours after receiving her shot that she experienced swelling behind her eyes and legs that lasted into the next day, and brief swelling of the tongue that wasn't severe and subsided over night.
29 2021-07-27 vision blurred Blurred vision; This is a spontaneous report from a contactable pharmacist. A 29-years-old female pa... Read more
Blurred vision; This is a spontaneous report from a contactable pharmacist. A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0161 and Expiry date: Jul2021) dose 1 via an unspecified route of administration, administered in Arm Left on 02May2021 at the age of 29-years-old as 0.3 ML single dose for Covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. On 02May2021, the patient experienced blurred vision. The caller was looking and didn't see where blurred vision was a side effect. The caller wants to know if it is okay for the patient to received the second dose. The patient can still see, the patient went to the doctor about this event and the doctor said it should go away with time. The outcome of event was not recovered.
29 2021-07-28 loss of taste Stuffy nose; Loss of taste; headache; Fatigue; This is a spontaneous report from a contactable consu... Read more
Stuffy nose; Loss of taste; headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Apr2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included vitamin D, ascorbic acid (VITAMIN C) and synthetic prenatal vitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received Ibuprofen and experienced allergy. The patient also previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021 at 13:00, the patient experienced stuffy nose, loss of taste, headache and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events stuffy nose, loss of taste, headache and fatigue were not resolved. No follow-up attempts are needed; information about lot number cannot be obtained.
29 2021-07-29 mouth lesion Rash on the inside of mouth, near lips and on both sides of mouth.; This is a spontaneous report fro... Read more
Rash on the inside of mouth, near lips and on both sides of mouth.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route of administration in the right arm on 06Apr2021 at 12:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE) from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 07:00, the patient experienced rash on the inside of mouth, near lips and on both sides of mouth. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the reported event which included lidocaine ointment. The clinical outcome of the events rash on the inside of mouth was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
30 2020-12-31 toothache, ear pain 12/28/2020-1230 began feeling numbness/tingling left foot, left hand, left cheek (face), intermitten... Read more
12/28/2020-1230 began feeling numbness/tingling left foot, left hand, left cheek (face), intermittent 1500- chest tightness, palpitations lasting 20-30 minutes 1900- feet b/l ice cold, muscle aches, chills, lasting 8 hrs 12/29/2020- upon awakening-fatigue, SOB 6 hrs, intermittent paresthesia persist left foot, left cheek, new onset teeth pain (lasts less than 1 minute) left sided headache (1-5 min) left sided back pain at SI joint 12/30- tingling sensation persist, fatigue is gone. Chills- 1-3 min duartion, intermittent. left ear pain, left headache, "pings " of left cheek, tingling back pain persists (left) 12/31/2020 noted mild left facial weakness-, left eye brow rise, unilateral wrinkle forehead, smile reduced left sided tingling persists with intermittent headache, ear pain, teeth pain sought care of PCP tx of early onset bells palsy with steroid taper + PPI Began prednisone 40 mg PO 1/1/2021 left sided back pain persists
30 2021-01-01 pain in jaw Vaccine given at 7:05am 12:00noon, 5 hours later, I started experiencing severe chest pain, jaw pain... Read more
Vaccine given at 7:05am 12:00noon, 5 hours later, I started experiencing severe chest pain, jaw pain and shortness of breath in which EMS was called and I was taken to the hospital. Since then, I lost feeling in my hands and feet, numbness and tingling. I've improved however, during my recovery suffered with spinal pain, shortness of breath, very winded, muscle pain and loss of appetite to especially meat.
30 2021-01-02 visual impairment For her hours after vaccine administration, experienced 10 to 15 minutes of left lower quadrant visu... Read more
For her hours after vaccine administration, experienced 10 to 15 minutes of left lower quadrant visual field defect. Was not associated with headache or other neurologic (sensory or motor) deficits. Patient with history of headaches and remote history of migraines but never migraine with aura. No personal or family history of cardiovascular disease or stroke. Visual field defect resolved completely and has not been experienced sense.
30 2021-01-04 tunnel vision 12/29/2020 VACCINATION. WAS IN SITTING AREA, FELT FINE. AFTER 20 MINUTES, WALKED OUT OF ROOM AND FE... Read more
12/29/2020 VACCINATION. WAS IN SITTING AREA, FELT FINE. AFTER 20 MINUTES, WALKED OUT OF ROOM AND FELT LIGHT HEADED AND DIZZY. NEAR SYNCOPY EPISODE, TUNNEL VISION, PALE.
30 2021-01-05 taste impairment At approximately 1630, patient was getting ready to leave the vaccine clinic. She advised writer tha... Read more
At approximately 1630, patient was getting ready to leave the vaccine clinic. She advised writer that she had a strong metallic taste in her mouth. It started 10-15 minutes after the injection. Denied all other symptoms that could be considered a side effect or allergic reaction to the vaccination. Advised patient she could stay later for further observation. Patient declined to stay. She felt fine otherwise. Patient was further advised if develops shortness of breath, or throat tightening to call 911 immediatley. Patient verbalized understanding. She indicated that she does have an epi pen due to allergies and will use it if necessary. Called patient at approximately 1830. She informed writer that she did have the strong Metallic taste in her mouth that started 15 minutes after the immunization and it lasted for about 1 hour. She reports that she was slightly light headed once she got home. Patient is not sure if it is due to starting night shift last night or if it was from the vaccine. Patient encouraged to increase her water intake. She was also encouraged to call PCP's office if light headedness does not completely resolved. If develops life threatening symptoms, to call 911. She was in agreement with plan. Writer will completed VAERS report tomorrow.
30 2021-01-05 eye pain Pain in site of injection, malaise, chills, retro orbital pain for approximately 24h.
30 2021-01-05 eye itchiness I took the vaccine on Sunday and Monday morning my arm was sore and in the afternoon my arm was itch... Read more
I took the vaccine on Sunday and Monday morning my arm was sore and in the afternoon my arm was itching but not at the injection site, lower. then my eye started itching a little later. I got scared and went to the UC and they told me to take Benadryl. It was just for a day after I took the Benadryl the next day all was back to normal.
30 2021-01-05 mouth numbness Began experiencing her lip quivering on the right side of her mouth, specifically her lower lip, als... Read more
Began experiencing her lip quivering on the right side of her mouth, specifically her lower lip, also the gums underneath where her lip is quivering feels numb. Just feels the sensation, but states her lips/face are symmetrical.
30 2021-01-05 vision blurred 1215-Noted pt sitting on the floor fanning herself after receiving her COVID vaccine. 1220-Pt ambul... Read more
1215-Noted pt sitting on the floor fanning herself after receiving her COVID vaccine. 1220-Pt ambulates to stretcher for further evaulation of clinic staff, FNP. Patient reported no previous adverse reaction to vaccines, but did note an anaphylactic nut allergy. Pt reported a milder version of the symptoms she is experiencing today after her initial vaccine Dec 17, 2020. Initial HR 64 SPO2 74% room air(employee wearing dark fingernail polish and reporting tingling in her hands) Pt instructed to breath slowly in through nose, out through mouth. 1225 BP 150/95 HR 85 SPO2 99% Pt given some water and crackers and reports eating NO food today other than a few cookies. Pt reports feeling better, color has now returned to pt. 1235- BP systolic 180s. pt advised to be seen in the ED for further evaluation. 1240 patient taken to ED by this RN; FNP; and second RN for further evaluation. 2L SPO2 put on pt en route based on previous low oxygenation. 1245- Pt arrived in ED, pt began reporting blurred vision; handoff to ED staff. Evaluated by ED staff, medicated with 1L NS bolus, 125mg IV Methylprednisone; 20mg IV Famotidine, 50mg IV Benadryl. 1640-employee reported to ED complete resolution of symptoms . Employee discharged from ED with prescription for an Epi-pen and prednisone.
30 2021-01-07 mouth itchiness, lip itchiness, tongue itchiness Patient complained of itching of tongue, mouth, and lips. Given Benadryl 50mg po, Pepcid 40mg, and ... Read more
Patient complained of itching of tongue, mouth, and lips. Given Benadryl 50mg po, Pepcid 40mg, and Xyzal 5mg. Shortly after complained of hoarseness. No respiratory, GI or cardiovascular symptoms. ENT consulted. patient observed for 3 hours.
30 2021-01-07 oropharyngeal discomfort throat felt different to swallow
30 2021-01-07 swelling around the eyes, eye swelling, lip swelling periorbital edema, lip swelling Narrative: ED note: This is a 29 year old employee who got her COVID... Read more
periorbital edema, lip swelling Narrative: ED note: This is a 29 year old employee who got her COVID vaccine yesterday. This morning she noticed facial puffiness, mostly around her eyes. No swelling of lips, toungue, no trouble swallowing or speaking, no swelling of throat, no SOB, no n/v or dizziness. Here she had some mild periorbital puffiness that I would not be aware of if she did not point it out to me. There is no swelling of her lips, airway and no SOB or problems with her voice. Her symptoms are improving in the ER. I think it is unlikely that this delayed symptom is related to the vaccine, however, she also states she had some swelling of the right side of her lip yesterday (none today), so I'm going to prescribe her an epi-pen.
30 2021-01-07 vision blurred Approximately 5 minutes after receiving vaccine her right eye became blurry. No other symptoms. No... Read more
Approximately 5 minutes after receiving vaccine her right eye became blurry. No other symptoms. No headache. BP 137/82 Pulse 92. Within 5 more minutes her right eye went dark. She was taken to ED. They did a CT scan and diagnosed her with ocular migraine. She was given benadryl, compazine and IV fluids. Symptoms resolved.
30 2021-01-08 eye pain severe body aches, swollen and painful lymph nodes in both armpits and bilateral neck, achy joints a... Read more
severe body aches, swollen and painful lymph nodes in both armpits and bilateral neck, achy joints and muscles, headache, achy eyes, extreme tiredness, itchy all over and swollen, painful and itchy injection site.
30 2021-01-08 ringing in ears Tinnitus
30 2021-01-08 vision blurred BlurredVision NauseaVomiting & Syncope Narrative: 15 minutes after vaccine was given, employee repo... Read more
BlurredVision NauseaVomiting & Syncope Narrative: 15 minutes after vaccine was given, employee reported visual changes and nausea. Then she lost consciousness for several seconds while seated. Emergency response team was called, no treatment was provided except supportive care and ginger ale when she regained consciousness. She was placed on cardiac monitor and observed for 30 minutes, initial HR was in 50's sinus bradycardia and BP 102/62. No further issues after 30 mins of observation time and employee was released to return to work. Employee reported having a similar reaction after giving blood in past.
30 2021-01-09 loss of taste About 12 hours of receiving my second dose I started to get really bad chills. Nothing could keep me... Read more
About 12 hours of receiving my second dose I started to get really bad chills. Nothing could keep me warm and I had a fever of 102. I had muscle aches as if I just went through a rigorous workout. I had zero appetite but I?m not sure if that was due to side effects or the fact that I wasn?t feeling well. When I did finally eat something that evening I could barely taste it, I ate it but my taste buds were faintly picking up the flavors. Again I don?t know if it was because of the side effects or the fact that I wasn?t feeling well. The following day, Saturday 01/09/21 I only had chills which would come and go. I did not have fever and my appetite was back. Now today, 01/10/21 I feel my usual self.
30 2021-01-10 dry mouth, mouth numbness Immediate numbness on top of left hand, tachycardia, flushing, dizziness, dry/numb mouth, feeling fa... Read more
Immediate numbness on top of left hand, tachycardia, flushing, dizziness, dry/numb mouth, feeling faint, lethargy. Was wheeled to ED where they left me in the waiting room for two hours, not seen by a provider, before being told I was "fine" and sent home. On 1/9/2020 I began experiencing widespread bodily itch, no hives or swelling that included in and around my mouth. Took cirtirizine and symptoms were alleviated.
30 2021-01-10 hearing loss Within seconds of vaccine administration, I felt flushing of my upper and lower extremities as well ... Read more
Within seconds of vaccine administration, I felt flushing of my upper and lower extremities as well as muffling in my right ear. My hands and feet became clammy. A small fan helped subside symptoms momentarily. Within minutes my lower extremities became shaky. I developed chills and felt faint. VS were measured. I was hypertensive (BP 134/100, baseline BP usually runs 110/80s). I developed intermittent tachycardic and heart palpitations, with a max HR of 124. Symptoms lasted approximately 1hour post vaccine administration. I work at a COVID testing site, chances of me being exposed to COVID-19 are high. I was not tested prior to receiving either dose of the vaccine; however, I have remained asymptomatic for the duration of the series.
30 2021-01-10 swollen tongue hives- like breaking out on fore head a lot of swelling in face numbness glands swollen under tongue
30 2021-01-11 ringing in ears Vertigo sx, dizziness, tinnitus , sx are improving.
30 2021-01-12 taste impairment, swollen tongue 11 minutes after vaccine this employee developed a metallic taste in her mouth, tachycardia and hive... Read more
11 minutes after vaccine this employee developed a metallic taste in her mouth, tachycardia and hives on her chest and neck. She reports her heart rate normalized quickly. Before she went to bed, she felt her tongue slightly swell and developed a scratchy throat. She reports the top portion of her throat feeling swollen as well. Benadryl resolved the symptoms.
30 2021-01-12 mouth numbness Mild facial numbness around mouth
30 2021-01-12 swollen tongue Tongue swelling. Resolved with benadryl.
30 2021-01-13 loss of taste Day of vaccination no symptoms. Day after about 0730 had slight headache, sore arm, fatigue and loss... Read more
Day of vaccination no symptoms. Day after about 0730 had slight headache, sore arm, fatigue and loss of taste. Day 2 post vaccination only loss of taste, slightly improved.
30 2021-01-13 mouth pain, swelling around the eyes Puffy eyes, weird feeling in mouth and possibly throat
30 2021-01-13 oropharyngeal discomfort Itching, facial tightness, flushing, throat changes. Was given Epi x 1, Bendaryl x 1 and Hospital Ra... Read more
Itching, facial tightness, flushing, throat changes. Was given Epi x 1, Bendaryl x 1 and Hospital Rapid Response called and she was brought to ED. At ED, evaluation done, pt stable, felt to be likely anxiety/panic attack as cause of symptoms, and low likelihood of anaphylaxis. Pt was given rx for Epi pen to keep on hand just in case.
30 2021-01-13 mouth tingling Dizzy, tingling in left arm, chest tightness and heaviness, tongue feels weird
30 2021-01-13 sensitivity to light Less than an hour after the shot, i had a sore arm, headache and slight sensitivity to light. I took... Read more
Less than an hour after the shot, i had a sore arm, headache and slight sensitivity to light. I took 975mg of Tylenol when I got home in the evening. But 12 hrs later after the vaccine shot, i woke up with severe body aches, chills, headache. Then i took another 975mg Tylenol but 3 hours later I started having fever that?s on and off. My fever even went up to 102.5F and the headache is very bad that is not relieved by Tylenol.
30 2021-01-14 sensitivity to light Reported headache,light sensativity,pain, heart palpitations and fever 103F
30 2021-01-15 pain in jaw Neck stiffness/left jaw pain and stiffness within 1 hour of administion, lasting all day. Around 210... Read more
Neck stiffness/left jaw pain and stiffness within 1 hour of administion, lasting all day. Around 2100 the same night, rapidly progressing paresthesia of complete left face without obvious facial palsy yet (numbness happened over the course of about 30min to the point where I had no perception of touch in the left face). At this point I took 60mg of prednisone and went to bed. When I woke up, the paresthesia/stiffness was less and progressively so since finishing a course of prednisone. Concerned that this could have been a bells palsy reaction to the vaccine.
30 2021-01-16 ear pain Immediately after the vaccine, my arm started burning in my neck and opposite arm joints became very... Read more
Immediately after the vaccine, my arm started burning in my neck and opposite arm joints became very sore throughout the day my entire body became extremely sore and I developed an ear ache and a headache and I am very fatigued. Today is the 17th of the month and that your aching headache still has not always go away. I?m not sure if this is a normal reaction or not.
30 2021-01-18 ear infection I got an ear infection. Don't know if it's related to vaccine shot.
30 2021-01-18 sensitivity to light Shortly after the vaccine I started having a migraine and extreme light sensitivity. Today I have gr... Read more
Shortly after the vaccine I started having a migraine and extreme light sensitivity. Today I have gradually become nauseated, have a poor appetite, feel very lethargic, and have a mildly sore arm.
30 2021-01-19 ear infection Had a cluster headache - that started the day of (started as a dull headache) and it continued throu... Read more
Had a cluster headache - that started the day of (started as a dull headache) and it continued throughout the next day. The next night it woke me up in the middle of night - terrible pain in my head. And continued for three weeks. I called my PCP - He said take Tylenol and drink water. Went to Urgent care on January 4 and they prescribed Imitrex for migraines and an antibiotic for double ear infection .I still have a little headache. I have an appt to go back to check my ears because they are still draining.
30 2021-01-19 mouth itchiness Started with itchy mouth and itchy soft palate. Progressed to itchy throat. Gave 50mg of Benedryl wi... Read more
Started with itchy mouth and itchy soft palate. Progressed to itchy throat. Gave 50mg of Benedryl with no relief, progressed to difficulty breathing, and increased throat itching. Gave EPI pen and sent to ER
30 2021-01-20 sensitivity to light Severe body aches especially neck and back pain, nausea/vomiting, severe headache unrelieved by over... Read more
Severe body aches especially neck and back pain, nausea/vomiting, severe headache unrelieved by over-the-counter medication, light sensitivity, fatigue, severe injection-site pain, chills with low-grade fever (99.8F). Symptoms listed began approximately 18 hours after 2nd COVID-19 vaccine was given and lasted until 48 hours after vaccine was administered.
30 2021-01-20 sensitivity to light I had mild to intense sensitivity to light within 5 hours of the vaccine. Around 9pm the night of my... Read more
I had mild to intense sensitivity to light within 5 hours of the vaccine. Around 9pm the night of my second and final dose, I could not settle. I tried to sleep under my usual schedule and routine. I kept waking up for no apparent reason. I felt like my body would rest but my brain never actually fell into sleep. I was not able to achieve REM sleep until around 7am. I woke up late around 11am feeling like I passed out from sleep deprivation. I woke feeling like I had a strange "hang over". I felt dizzy and light headed. I had a general feeling of being unwell. I had a pressure in my head above my temples that circled my head to the back of my crown area.
30 2021-01-20 vision blurred About a week after the vaccine the patient reported feeling extra fatigued, blurred vision, vivid dr... Read more
About a week after the vaccine the patient reported feeling extra fatigued, blurred vision, vivid dreams, and a depressed mood. Patient is following up with per primary care physician and eye doctor
30 2021-01-21 mouth tingling, swollen tongue 30 yr old getting vaccinated as an employee of hospital. Within minutes of vaccination, developed t... Read more
30 yr old getting vaccinated as an employee of hospital. Within minutes of vaccination, developed tingling in mouth, swelling of tongue, rash on arms and chest (rest of body not examined in room). GIven epi and brought to ER. BP within normal range, exact number not available. In ER given Benadryl and Pepcid, other medications not recollected. Admitted for observation into hospital for one night, discharged next day and doing well.
30 2021-01-24 taste impairment Patient immediately on administration became flushed, reported metallic taste in her mouth, thickeni... Read more
Patient immediately on administration became flushed, reported metallic taste in her mouth, thickening of her throat, and light headedness. VS, O2 6l/min via NC and EPI 0.3mg/0.3ml IM injection given and patient transferred to ED.
30 2021-01-24 swollen gums 2 or 3 days post vaccine noticed gum swelling behind top front tooth. Went to the dentist on 1/13 fo... Read more
2 or 3 days post vaccine noticed gum swelling behind top front tooth. Went to the dentist on 1/13 found no cause of symptoms via x-ray or visual inspection. Messaged Primary Care Doctor on 1/19 explaining symptoms with no resolution. Did explain this happened post vaccine. Treatment recommended was ibuprofen 600mg 3X's a day. I managed symptoms with ibuprofen but returned back to the dentist on 1/22 since I could not go without the ibuprofen. They visually see no immediate cause, but decided to make mouth guards to see if grinding at night is causing the issue, other possible problem would be I still have my wisdom teeth. Primary Care Dr. suggested I report this in case it was vaccine related since there is no real way to know for sure.
30 2021-01-25 taste impairment Patient c/o metallic taste, chest tightness, SOB, difficulty breathing, and difficulty swallowing. A... Read more
Patient c/o metallic taste, chest tightness, SOB, difficulty breathing, and difficulty swallowing. Also had a mild erythematous rash. Symptoms began < 5 minutes after vaccination. Epi Pen was administered and code team took patient to the emergency room. In the emergency room the patient was treated with benadryl (50mg PO once), prednisone (60mg PO once), famotidine (20mg PO once)and monitored for 4 hours. Symptoms improved and patient was discharged home safely.
30 2021-01-26 mouth tingling Chest pain since 12/25/2020 (no treatment, written off as anxiety), flare of bursitis since 12/25/20... Read more
Chest pain since 12/25/2020 (no treatment, written off as anxiety), flare of bursitis since 12/25/2020 (solumedrol injections from rheumatologist in right knee and both shoulders), tingling in fingers, toes, & lips since 12/25/2020 (no treatment), psoriasis flare of face since 12/25/2020 (never experienced before reaching out to dermatologist) Low grade fever off and on 12/31/2020 until 1/11/2021
30 2021-01-27 ear discomfort Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following ... Read more
Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following symptoms: dizziness burning sensation in the right side of her neck and r ear Lot: EL 3247 Time of Administration: 1:10pm in LEFT arm Time Symptoms Began: 1:40pm when she stood up. Felt a rush and then got dizzy She was given a pink card-dizziness and numbness in legs after last vaccine. For the next few days, she had intermittent dizzyness, nausea, extremely tired _____ Patient alerted observer who took the patient to the medical observation area. I was alerted and responded. She was sitting on the couch in the observation room. Initial Assessment @ _1:42om_: Patient is Patient is AAO. The employee is sitting up on the sofa. The employee is pink and does not appear to be in distress. She is talking and making conversation. She was given a Ginger Ale. We made convsersation for the next ~10 minutes. She was in no distress at all. Vitals @: 155pm HR: 79 BP: -- O2: 98 Employee was discharged without treatment. The RN was notified for follow up. Patient wil call us if anything progresses.
30 2021-01-27 mouth tingling Tingling tongue, monitored VS. 50 mg of Benadryl.
30 2021-01-27 sensitivity to light, vision blurred immediate tingling in injected arm which went after 10 minutes photophobia and blurred near vision 3... Read more
immediate tingling in injected arm which went after 10 minutes photophobia and blurred near vision 30 mins after vacc 8 hours after vacc: severe headache, chills, joint pain over whole body, extreme fatigue, sinus congestion. these lasted over 24 hour period.
30 2021-01-28 mouth tingling, mouth numbness Post covid vaccine administration, while sitting for 10 minute time frame, complained of numbness an... Read more
Post covid vaccine administration, while sitting for 10 minute time frame, complained of numbness and tingling in mouth and tongue. States she is allergic to apples and avacodos and this is the type of reaction she normally has after eating this type of food. Patient evaluated by facilitator. No difficulty breathing or shortness of breath noted, patient not in distress. Numbness and tinging continued past 10 minutes observation time not improving. ERT called to evaluate patient. No distress noted. Taken to pharmacy and received oral diphenhydramine. Sitting in clinic for additional time frame - total approximately 70 minutes post vaccine. Complaints of feeling some nausea. No distress again noted. Continues to complain of tingling and numbness in mouth and tongue at 1800 which is approximately 40 minutes post medication. Additionally complaints of feeling more numbness around mouth. VS taken: T - 37.1, P - 68, BP - 128/80, R- 18, pulse ox - 100%. No difficulty breathing. States situation unchanged from previous. ERT notified again. Patient evaluated by team. Options discussed with patient by team nurse - can be seen in ED or go home and take additional dose of antihistamine in 4 hrs from time of first dose. Encouraged to get a ride home and leave car at hospital. Husband called by patient. Waiting for ride. Encouraged to seek additional medical care if not feeling improved after 2nd dose of medication at home. Also encouraged to discuss 2nd vaccine dose with PCP prior to taking 2nd dose. Discussed with patient to utilize vaccine app to document post vaccine effects. Escorted to hospital lobby for ride at 1830.
30 2021-01-28 mouth tingling Tingling on the lips at 20/30 minutes observation
30 2021-01-29 mouth discomfort After receiving the first dose of pfizer covid-19 vaccine, pt had stated she had itchy and burning s... Read more
After receiving the first dose of pfizer covid-19 vaccine, pt had stated she had itchy and burning sensation in right and left jaw, as well as same sensation on the upper lip. Treatment for symptoms included oral intake of Cetirizine 10mg. Pt was observed for 30 minutes without any developing reactions.
30 2021-01-29 ringing in ears Began experiencing tinnitus one week after first dose, second dose seemed to amplify symptoms.
30 2021-01-29 visual impairment Roughly 15 minutes after the vaccine I began to blackout. I did not fully lose consciousness but my ... Read more
Roughly 15 minutes after the vaccine I began to blackout. I did not fully lose consciousness but my field of vision was taken over by spots and stars. My blood pressure was very low. After being monitored for 45 mins I felt well enough to go home.
30 2021-01-31 dry mouth Started feeling poorly around 9:30 PM on 1/30. By 10 PM I had fever, chills, anxiety, dry mouth, hea... Read more
Started feeling poorly around 9:30 PM on 1/30. By 10 PM I had fever, chills, anxiety, dry mouth, headache, body aches, and I had a hard time staying asleep. I rarely wake during the night to pee but I woke 4 times for water and to use the bathroom. I woke more than that, but 4 times specifically for that reason. My fever broke the next morning (1/31) around 6 or 7 AM. I still had a mild headache and felt tired and not like myself. I took ibuprofen and the headache subsided. Around 2 the headache came back as did the anxiety. I am not a typically anxious person. I took another dose of ibuprofen. Around 10 that evening (1/31) I felt back to normal.
30 2021-01-31 ear pain Fever; chills; Restlessness; fatigue; constant headache; Periodic chest pain that radiates to upper ... Read more
Fever; chills; Restlessness; fatigue; constant headache; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; This is a spontaneous report from a contactable healthcare professional reporting for self. This 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL 3302) on 17Jan2021 08:45 AM (vaccine location= Left arm) at single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number= EL1284) on 27Dec2020 09:15 AM (vaccine location= Left arm) at single dose for Covid-19 immunisation. Patient did not have other vaccine in four weeks, and did not have other medications in two weeks. No known allergies. Patient was not pregnant. The patient experienced fever and chills approximately 11 hours after vaccine. Restlessness, fatigue and constant headache. Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back. Fever went away about 16 hours after fever onset and was coming back approximately 36 hours after vaccine dose. The events onset date was reported as 17Jan2021 08:00 PM. No treatment received. Patient did not have COVID prior vaccination, did not test COVID post vaccination. Outcome of events was recovering.
30 2021-01-31 mouth tingling, loss of taste Loss of taste, tingling in face and mouth. Lasted for 2 days.
30 2021-01-31 ringing in ears Pulsatile tinnitus
30 2021-02-01 loss of smell, loss of taste extremely fatigued; congested; ended up losing her sense of smell over the weekend; ended up losing ... Read more
extremely fatigued; congested; ended up losing her sense of smell over the weekend; ended up losing her sense of taste over the weekend; headache and terrible sinuses/sinus headaches; felt the scratchiness in her nose; felt the scratchiness in her throat; This is a spontaneous report from a non-contactable healthcare professional. A 30-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), intramuscular left arm on 07Jan2021 14:00 at a single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously took benzoyl peroxide and clindamycin (BENZACLIN) but had allergies. The patient reported that within 4 hours (07Jan2021 06:00 PM), she felt the scratchiness in her throat in and nose. The next morning (08Jan2021), she was extremely fatigued, congested, and ended up losing her sense of taste and smell over the weekend, for the next week. She also had headache and terrible sinuses. Treatment was received for the adverse events. The patient received acetaminophen (TYLENOL) as treatment for sinus headaches. The patient was not diagnosed with Covid prior to vaccination and was not covid tested post vaccination. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
30 2021-02-02 feeling of choking patient had vaccine and more than 15 minutes later after she left the clinic she came back with c/o ... Read more
patient had vaccine and more than 15 minutes later after she left the clinic she came back with c/o sob, tingling in hands and throat. Had previously felt the throat tingling when she had covid-19 virus. Patient reported anxiety and was tachycardia and hypertensive. sat in clinic for additional thirty minutes and vitals normalized and no further complaints.
30 2021-02-03 eye twitching Pfizer-BioNTech. I suffered from chills, headache, joint and muscle aches, and nausea. The symptoms ... Read more
Pfizer-BioNTech. I suffered from chills, headache, joint and muscle aches, and nausea. The symptoms were severe from 7:30 pm on Monday, the day of the dose (vaccine received at 9:30AM), until 5:30 PM Tuesday (approximately 22 hours). The symptoms were relieved by taking extra strength tylenol every 4 hours. The symptoms were lessened, but still present until 9:30 AM on Wednesday. I was still suffering from a minor headache all day Thursday. I also had soreness in the injection site, there was no swelling or redness that I noticed; the soreness was mostly gone by Thursday. I have had a left eyelid twitch in the past (randomly), it returned after the vaccine and was very bothersome. Today is Thursday and the eyelid twitch is still bothering me.
30 2021-02-03 mouth numbness, dry mouth, mouth tingling anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting fo... Read more
anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting for herself. A 30-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 prophylaxis . Medical history included ongoing asthma Diagnosed when she was a child , seasonal allergy , food allergy , contrast media allergy (gadolinium). There were no concomitant medications. The patient experienced anaphylactic reaction on 13Jan2021 with outcome of recovered , had a fever of 100.8 on 13Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included allergy test: unknown results on Jan2021 , body temperature: 100.8 on 13Jan2021. The reaction began 28 minutes later. She says she started to get jumpy, her hands swelled and got itchy. She couldn't bend her hands, they were so swollen that she couldn't bend them. Her legs were shaking. Then saline and eventually her mouth started to get numb and they used an Epi pen twice. Her throat never closed, she thinks it did not close because the Epi pen was done twice, She had 2 masks on she cannot say for sure if she had trouble breathing but her mouth began to get dry and tingly and she started to no be able to feel her mouth. She says she would says it was resolved completely the next day. The patient also received Decadron and Benadryl. The reporter would say the event were life threatening because they treat it that way due to anaphylaxis precautions. Follow up information has been requested.
30 2021-02-03 swollen tongue Received initial COVID vaccine at about 1200 today. About ten minutes later started to feeling burni... Read more
Received initial COVID vaccine at about 1200 today. About ten minutes later started to feeling burning CP, SOB, feeling of tongue swelling, and had a loose stool. Now feeling lightheaded. Was feeling fine prior to the immunization. Anxiety. Anaphylaxis. 30 yo female known hx of allergic reaction/atopy to vaccines presented with anaphylaxis approx 10 minutes after the covid-19 Pfizer vaccine.
30 2021-02-05 lip swelling Patient presented to COVID-19 Vaccine clinic on 02/06/21. Reported listed allergies (see nots above)... Read more
Patient presented to COVID-19 Vaccine clinic on 02/06/21. Reported listed allergies (see nots above) and pharmacist noted throat swelling and shortness of breath for reaction. Patient received 1st dose of Pfizer COVID-19 Vaccine and reacted to administration. Patient experienced lip swelling, which triggered pharmacy staff to follow Albertson's/Acme Markets Vaccine Emergency Protocol - Patient took diphenhydramine 25mg by mouth. Reaction continued and a rash developed, which spread from her lower extremities and covered her stomach. Patient took another diphenhydramine 25mg by mouth. An ambulance was called and arrived at clinic. At that time, she reported feeling better due to diphenhydramine. She DID NOT receive Epi-pen, and did not take ambulance to emergency department. However, she is reporting to emergency department for follow-up.
30 2021-02-06 eye strain, bloodshot eyes Flu symptoms 1 hour after getting home . Fatigue, runny nose, red eyes, tired eyes, body aches, diar... Read more
Flu symptoms 1 hour after getting home . Fatigue, runny nose, red eyes, tired eyes, body aches, diarrhea . Sore arm, swelling, painful to move arm
30 2021-02-07 swollen tongue Patient at site for 1st dose of COVID Vaccine. Patient approximately 2 minutes after receiving vacc... Read more
Patient at site for 1st dose of COVID Vaccine. Patient approximately 2 minutes after receiving vaccine at 1028 started feeling tongue swelling with throat itching. Patient taken to first aid room where she was assessed by provider and ems on duty. Patients skin was red and flushed and with slight swelling of the tongue noted. Patient still A7 O x4 with respirations even and unlabored. Patient had O2Sat of 96% on RA. Patient states she has an allergy to all Bovine proteins and had a mini-stroke approximately 4-5 years ago. Patient is a healthcare worker and is currently at home with newborn son. Provider ordered Benadryl 25mg PO and pt received 1st dose at 1045. Then provider ordered a second dose of Benadryl 25mg after patient stated her Jaw felt "Wonky" and patient received at 1048. Pt slowly responded to treatment and after 15 minutes from first dose of Benadryl patient had a decrease in redness and tongue swelling. Itching was slowly decreasing. At 1105 patient stated itching had subsided and by 1110 patient had a full return to baseline. Pt discharged at 11:15 home and pt communicated understanding that she was ok to drive and that she should follow up with PCP prior to receiving second dose of vaccine. Also, patient was able to communicate understanding of a rescue plan at home if symptoms should flare up again. Patient stated she did have an epi pen at home as well and note if she needed to she would use epi-pen and seek immediate medical attention after use.
30 2021-02-07 vision blurred Incredible arm/shoulder/lymph node pain starting 10 hours post-vaccination lasting about 60 hours. A... Read more
Incredible arm/shoulder/lymph node pain starting 10 hours post-vaccination lasting about 60 hours. About 12 hours post-vaccine, uncontrollable muscle spasms began and lasted approximately 2 hours. In this time, arm/shoulder/lymph node were extremely swollen. During the muscle spasms, I experienced my first or two "attacks". Speaking and thinking became difficult - at times I felt as though I was trapped in my own head unable to speak or move how I wanted (motor function was possible but sluggish and requiring assistance to become ambulatory). The worst of this lasted about 4 hours, though my brain remained some level of "foggy" 48 hours post-vaccination. 1-2 hours into these neurological issues, I lost the ability to feel throughout my whole body. I could tell there was a sensation on my skin, but I could not tell if it was hot/cold/pain/pressure. I could not feel if I was swallowing, drinking water, or breathing, though I could move enough to perform these activities. Vision was hazy during these attacks and for a while after. The worst of all these effects lasted 3-4 hours. It then took about 5-6 hours to regain all feeling, though my brain was still foggy/hazy. Heavy swelling lasted several hours, then became moderate swelling, and after 48 hours, there was little to no swelling. About 22 hours post-vaccination, I had another one of these "attacks", not including the muscle spasms. This second attack was identical to the first in every way, except it was slightly less severe. Recuperation time was again 5-6 hours. It is currently about 70 hours post-vaccination and most symptoms except moderate arm soreness are gone. During both attacks, BP and temperature were normal, heart rate slightly elevated (80-85 bpm). Other non-severe effects included fatigue, slight chills/flush.
30 2021-02-08 eye itchiness Systemic: Rash (other than injection site)- Mild, Systemic: Nausea- Mild, Systemic: Vomiting- Mild, ... Read more
Systemic: Rash (other than injection site)- Mild, Systemic: Nausea- Mild, Systemic: Vomiting- Mild, Systemic: Other- pt had itchy eyes, arms, neck and numbness around eyes
30 2021-02-08 pain in jaw I received the shot around 1:45 pm and I felt a warm/ burning sensation in my arm. I waited there fo... Read more
I received the shot around 1:45 pm and I felt a warm/ burning sensation in my arm. I waited there for 15 minutes and nothing happened. I get home and still felt fine. Around 6:30 pm I started to feel neck pain and stiffness as I continued to do house chores the pain just kept going up towards my neck into my left cheek where I feel numbness. My throat and jaw hurt as well. My neck is stiff and I can?t look to the left unless I turn my body. The back my head is also starting to hurt. My arm is sore where the shot was given but what hurts most is my neck, throat and head. I have body chills but no fever. I took Tylenol and called the dr on demand who told me to take Benedryl and if the symptoms got worse to go to the hospital.
30 2021-02-09 eye strain, eye twitching left eye keeps twitching; No immediate vision changes until later in the day when left eye gets tire... Read more
left eye keeps twitching; No immediate vision changes until later in the day when left eye gets tired; This is a spontaneous report from a contactable nurse (patient) reported that a 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm on 24Dec2020 07:45 at a single dose for Covid-19 immunization. The vaccine was administered at the hospital. The patient's medical history and concomitant medications were not reported. Patient is not pregnant. On 26Dec2020 (also reported as 'approximately 2 days after the first vaccination'), the patient's left eye keeps twitching. No pain. May intensify and becomes obvious. No immediate vision changes until later in the day when left eye gets tired. No treatment received for the reported events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
30 2021-02-09 mouth tingling, swollen tongue swelling and tingling of tongue VS 124/88 97 HR 100% RA SpO2
30 2021-02-10 taste impairment Fever/Undocumented fever; Chills; Numbness left body; Metallic taste; Headache; Body aches; Diarrhea... Read more
Fever/Undocumented fever; Chills; Numbness left body; Metallic taste; Headache; Body aches; Diarrhea; Fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiration date were not reported), via an unspecified route of administration on 05Jan2021 16:45 at single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was taking an unspecified concomitant medication. The patient previously took first dose of BNT162B on 26Jan2021 at 16:15 for COVID-19 immunization. On 05Jan2021 at 18:00, the patient experienced every reaction that was possible to the vaccine including fever (also reported as undocumented fever), chills, numbness left body, metallic taste, headache, body aches, diarrhea, and fatigue. The events were reported as non-serious and no treatment was given to the patient. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 with unknown results at the time of the report. The patient recovered from all of the events on an unspecified date. Information on the lot/batch number has been requested.
30 2021-02-10 lip swelling, mouth numbness, mouth tingling Pt first developed numbness and tingling of the lips which was followed by very slight upper lip swe... Read more
Pt first developed numbness and tingling of the lips which was followed by very slight upper lip swelling. This numbness and swelling improved without intervention but over the next 10 mins returned but this time with swelling of the lower lips. Pt has h/o atrial thrombus as well as reaction to epinephrine (drooling, tachycardia, unsteady gait). Benadryl 50 mg given in hopes that this will slow the reaction while patient was transported to the ER. While epinephrine was indeed warranted this was not provided given her comorbidities and prior reaction to epinephrine. Patient with stable vitals, no dyspnea. Ambulatedto the Ambulance without difficulty.
30 2021-02-12 swollen tongue patient noticed swelling feeling in tongue at about 10 mins post vac, we watched her until 15 minute... Read more
patient noticed swelling feeling in tongue at about 10 mins post vac, we watched her until 15 minutes and she still felt swollen tongue, no throat closing. gave her dose of Benadryl, checked again in 10 more minutes and still swollen talking sounded differently than normal, walked her over to urgent care they took over care
30 2021-02-15 vision blurred Blurry peripheral vision no weakness no airway or chest pain. Pt was able to be DC home with normal ... Read more
Blurry peripheral vision no weakness no airway or chest pain. Pt was able to be DC home with normal Neuro exam noted including visual fileds
30 2021-02-17 taste impairment, swollen tongue Tongue swelling, dysgeusia (metallic taste)
30 2021-02-17 mouth itchiness, tongue itchiness "Throat, pallet, and tongue itching; shortness of breath, and tachycardia"
30 2021-02-18 eye swelling 1/15/21 30-60MINS POST VACCINATION PT DEVELOPED FLAT RED RASH ALONG ANTERIOR REGION OF NECK . WITHIN... Read more
1/15/21 30-60MINS POST VACCINATION PT DEVELOPED FLAT RED RASH ALONG ANTERIOR REGION OF NECK . WITHIN 72HRS REDNESS SPREAD TO SKIN AROUND EYES BILATERALLY. ON 2/8/21 PT DEVELOPED EDEMA BILATERALLY AROUND THE EYES. EDEMA AROUND EYES IS SEVERE ENOUGH TO HAVE TO "PRY" EYES OPEN AND USE ICE PACKS TO REDUCE SWELLING AROUND 2/12/21 PT REPORTS RED RASH ON NECK SREADING TO POSTERIOR REGION OF NECK. 2/19/21 PT STATED SHE HAD TELEMED APPT WITH MD TO REVIEW PICTURES AND PT. PT WAS ADVISED TO TAKE CLARITIN OR ZYRTEC DAILY AND BENARDYL 25-50MG NIGHTLY.
30 2021-02-18 mouth tingling Patient received vaccination and was monitored for adverse events after approximately 20 minutes pat... Read more
Patient received vaccination and was monitored for adverse events after approximately 20 minutes patient presented with tingling in lips, tightness in throat and wheezing. Patient self administered 25 mg diphenhydramine orally and was given Dexamethasone 4mg IM left deltoid as per standing orders and onsite provider orders.
30 2021-02-19 eye pain, bloodshot eyes, eye discharge Individual received vaccine 2/18/21. Woke up morning of 2/19/21 with pain to right eye. Redness and ... Read more
Individual received vaccine 2/18/21. Woke up morning of 2/19/21 with pain to right eye. Redness and drainage noted to eye on morning of 2/20/21.
30 2021-02-19 mouth tingling 1/30 Reaction tongue and lips tingling. Right arm w rash and chest tightening. Today lips 8and ton... Read more
1/30 Reaction tongue and lips tingling. Right arm w rash and chest tightening. Today lips 8and tongue tingling. EMS evaluated. BP 128/84 P 86 SaO2 98% No further issues resolved - home 2:55
30 2021-02-20 eye swelling Body aches, chills, fever, vomiting, arm and armpit pain, swollen lymph nodes of the left underarm, ... Read more
Body aches, chills, fever, vomiting, arm and armpit pain, swollen lymph nodes of the left underarm, right eye swelling, rash in bilateral calves
30 2021-02-21 enlarged tonsils, inability to speak Fine for hour or so then began to lose voice slowly over the next few hours and cough. Shortness of ... Read more
Fine for hour or so then began to lose voice slowly over the next few hours and cough. Shortness of breath from simply walking around swelling of the glands and consul in the neck and throat
30 2021-02-23 lip swelling Noted difficulty swallowing 10 minutes post vaccination. Observed, given water, client notes previou... Read more
Noted difficulty swallowing 10 minutes post vaccination. Observed, given water, client notes previous rx to radio active iodine. Notes scratchy throat, tingling and puffy lips. Symptoms did not worsen over 60 minutes in observation. No difficulty breathing. Advised to take benedryl and seek medical attention if symptoms worsen. Patient left with her mother. RN called later in the evening, client confirmed sxs improved with Benedryl, feeling better.
30 2021-02-26 ear discomfort I woke up 4 days later 2/12, with both ear clogged or ear fullness. I felt out of balanced and a lit... Read more
I woke up 4 days later 2/12, with both ear clogged or ear fullness. I felt out of balanced and a little light headed. I also felt like my hearing was less. Next day 2/13 I only felt ear fullness on my left ear. 2/15 I woke up feeling fine. A week later 2/19 I woke up with the injection site hurting along with my leg ear clogged again. Again I felt out of balanced and light headed. I went to see an audiologist on the third day 2/21 while my ear was still clogged. They didn't see any wax or ear infection. They did a hearing test which showed normal hearing but worse on the left ear than the right. They told me I should see an ENT. 2/22 I woke up feeling fine. 2/24 I was asymptomatic when I went to see the ENT and my hearing test was normal but when they did a videonystagmography it showed significant positional nystagmus.
30 2021-02-27 eye pain 1/1/21- Severe right side eye pain 1/3/21 - Appearance of vesicular rash with sever pain above righ... Read more
1/1/21- Severe right side eye pain 1/3/21 - Appearance of vesicular rash with sever pain above right eyelid 1/3/21 - Diagnosed with Zoster Ophthalmicus of Right Eye at urgent care and initiated on Valacyclovir 1000 mg PO TID x 10 days 1/4/21 - Ganciclovir eye drops added to treatment course 1/10/21- Rash crusted and resolved but with severe neuropathic pain and itch 1/12/21 - Second dose of COVID vaccine received
30 2021-03-02 thirst, dry mouth Dry mouth; excessive thirst; This is a spontaneous report from a non-contactable healthcare professi... Read more
Dry mouth; excessive thirst; This is a spontaneous report from a non-contactable healthcare professional (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2, via an unspecified route of administration (Vaccine location: right arm) on 29Jan2021 20:00 at a single dose for COVID-19 immunization at a hospital. Medical history included insomnia, anxiety, sebbhoreic dermatitis, and Covid prior vaccination. Concomitant medications included retinol, dandelion, melatonin, and unspecified multivitamin. No other vaccine in four weeks. On 29Jan2021 11:00 PM, the patient experienced dry mouth/excessive thirst (this is a side effect she has not yet seen listed). Every other symptom was pretty par for the course. No treatment received for the events. No Covid test post vaccination. The patient recovered from both events on an unspecified date. No follow up attempts are possible. No further information is expected.
30 2021-03-03 feeling of choking Patient received the COVID-19 Pfizer vaccine at 01:33 PM on 2/28/21. Patient began to experience a s... Read more
Patient received the COVID-19 Pfizer vaccine at 01:33 PM on 2/28/21. Patient began to experience a scratchy throat, tingling and cough. She was given a Benadryl 50mg IM injection in the left deltoid at 1:55 PM. Patient's vitals at 2:00 PM: BP 132/88, SPO2 98%, HR 107. Patient began to have a change in voice and difficulty swallowing so an Epi pen IM Injection was administered at 2:05 PM in the right thigh. Epi pen lot number 0FM501, EXP 05/22. At 2:14 PM her vitals were taken again: BP 130/78, SPO2 99%, HR 104. At 2:26 PM, Solu-Medrol IM Injection was given in the left deltoid. Solu-Medrol lot number DP2618, EXP 01/2022. Patient's vitals were taken showed HR of 98 and SPO2 99%. Patient was released to home with mom.
30 2021-03-05 tongue disorder, eye swelling, swollen tongue Pfizer-BioNTech COVID-19 Vaccine EUA: patient developed soreness around injection site, chills, and... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient developed soreness around injection site, chills, and fever in the evening following vaccine administration. The next day developed rash, itching, and mild swelling below eyelids. Three days after vaccination patient reported tongue appeared red, bumpy, and a little swollen. Patient took diphenhydramine with some improvement overnight, then cetirizine the following day. It took another 24 hours- five days from vaccination- for tongue bumps and swelling to resolve.
30 2021-03-08 ear discomfort, eye floaters 20 minutes after injection inner ear pressure, light headedness, dizziness, faintness. Three hours a... Read more
20 minutes after injection inner ear pressure, light headedness, dizziness, faintness. Three hours after injection low grade fever, dizziness, fatigue. 24+ hours after injection headache, fever, arm soreness, inner ear pressure, hot flashes, neck tension, eye "floaters"
30 2021-03-09 ear pain Flu like symptoms on Day 5?sore throat, congestion, runny nose, headache, earache. No fever. Negativ... Read more
Flu like symptoms on Day 5?sore throat, congestion, runny nose, headache, earache. No fever. Negative COVID test. Symptoms lasted 3 days.
30 2021-03-09 hearing loss, ringing in ears Vasovagal syncope, onset 1 hour after vaccine administration. Resolved in ~15 minutes, upon lying do... Read more
Vasovagal syncope, onset 1 hour after vaccine administration. Resolved in ~15 minutes, upon lying down. Sudden lightheadedness, seeing stars; tunnel hearing, then tinnitus; leaned forward and lightheadedness continued to worsen, so I laid the car seat back; suddenly felt hot and started sweating profusely; slight nausea; bradycardia (which I never have - I am on a prescription stimulant, and usually run >80 when seated). Called roommate to pick me up and take me back to the vaccine site to check with paramedics there before continuing home.
30 2021-03-09 bloodshot eyes, eye swelling Sunday night my eyes were a little swollen and hurt when I blink. Monday morning both eyes were very... Read more
Sunday night my eyes were a little swollen and hurt when I blink. Monday morning both eyes were very swollen and extremely red, no pain and vision was mor effected.
30 2021-03-10 swollen tongue Experienced swelling of tongue, difficulty swallowing, feeling hot, feeling of elevated heart rate. ... Read more
Experienced swelling of tongue, difficulty swallowing, feeling hot, feeling of elevated heart rate. Administered 25mg Diphenhydramine with improvement. Patient sent home at 1500 with significant other and instructions to go to the ED if symptoms persist or worsen.
30 2021-03-11 mouth tingling Due to extensive history of allergies and concerns she was pre-medicated 30 minutes prior to vaccina... Read more
Due to extensive history of allergies and concerns she was pre-medicated 30 minutes prior to vaccination with 25 mg of Benadryl. At 1209 she started getting anxious and having tingling on her tongue. She progressed to nausea, throat tightness, shaking and then chest pain. EMS was called to transport to the ED
30 2021-03-13 loss of smell, loss of taste, loss of taste, loss of smell Congestion, headache, lack of taste/smell
30 2021-03-13 visual impairment Somnolence, pain in left arm, pain of left side of the body, problems with eyesight, feeling warm, a... Read more
Somnolence, pain in left arm, pain of left side of the body, problems with eyesight, feeling warm, annoyance, dizziness, weakness, liver and gallbladder pain.
30 2021-03-15 dry mouth Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by:, MD at 3/16/2021 9:55 AM ... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by:, MD at 3/16/2021 9:55 AM Expand AllCollapse All VACCINE CLINIXC 3/15/2021 Subjective Pateint is a 30 y.o. male who was seen at Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness and nausea, hot, dry mouth. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and vomiting. Past Medical History: Diagnosis Date ? Hernia ? Past Hospitalization Admit on: 20130219; Diagnosis: Aseptic meningitis, dehydration; at: HealthCare; MD; Hx of + covid infection in November 2020. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills and vomiting (scantly, x 3 times) Patient denies fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, rash, hives, itching of skin, abdominal pain, dizziness and headaches + nausea: + lightheaded: Previous Reactions: none with vaccines. Objective Vitals Vitals: 03/15/21 0956 03/15/21 1009 03/15/21 1032 BP: (!) 142/95 127/79 129/83 Pulse: 84 SpO2: 99% Blood Sugar 112 collected at 1045 Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is ill-appearing. He is not diaphoretic. Comments: Slightly flushed HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds and air entry. Abdominal: Tenderness: There is no abdominal tenderness. Skin: General: Skin is warm. Coloration: Skin is pale (improved with rest). Findings: No rash. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Patient with several brief episodes of dry heaving/burping throughout his observation here. He's managed to have scant amount of emesis. Pepcid 20 mg given, then zofran odt 4mg given, He was feeling better with ice pack and laying down. Upon sitting up he started to feel lightheaded and dizzy again. Restarted to burp with scant periods of nausea with dry heaves. Pepcid 20 mg given again. Pt able to sit up but still feeling nauseated. New ice pack given to neck. Pt asked to call for a ride. Security had to go out to his car to get his phone. Pt called his mom. Mom will come to pick pt up. Pt reports dizziness/lightheaded with position changes with increased nausea upon transfer to wheelchair. Assessment/Plan Treatment included: water, snacks and pecid and zofran. Follow up response to treatment: no change. Patient discharge: Transported to ED . Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Nausea and lightheaded/dizziness primarily. Pt monitored in bay for over an hour. Stable vs. Mom here to pick up patient and will transport to ED at for further evaluation/treatment due to failing PO challenge. Pt wheeled out in wheel chair. ED notified of patient coming. , APRN Electronically Signed 3/15/2021 10:12 AM
30 2021-03-15 vision blurred Fatigue, extended arm pain, dizziness, blurred vision, feeling feverish, nauseous, internal organ pa... Read more
Fatigue, extended arm pain, dizziness, blurred vision, feeling feverish, nauseous, internal organ pain, shaking
30 2021-03-21 taste impairment Metallic taste in mouth
30 2021-03-21 ringing in ears I received the 1st vaccine on 1/8/2021 and immediately my arm was very sore but was fine a few day a... Read more
I received the 1st vaccine on 1/8/2021 and immediately my arm was very sore but was fine a few day after. however when i got my second vaccine on 2/4/2021 is when I began to experience more side effects. My arm was extremely sore for more than a week. I could barely fully extend my entire arm and I developed a lump in the pit of my arm pit. Both my tricep and bicep mussels were tender. I also experienced headaches and tinnitus. The soreness of my arm and lump have gone away however I still have headaches and tinnitus to this day.
30 2021-03-23 ear itchiness, extreme sound sensitivity, ear pain Head and ear pain on left side began on 3/6/2021. I took Tylenol and OTC ear drops but pain continue... Read more
Head and ear pain on left side began on 3/6/2021. I took Tylenol and OTC ear drops but pain continued to get worse. 3/10- pain worsened, ear itched, hyperacusis began. 3/11- 8am Finally made an appointment in clinic due to the worsening ear pain and was prescribed ciprofloxacin/dexmethasone drops and told to contact clinic in 24 hours if symptoms didn?t improve. 3/11- 8pm noticed weakness on left side of face (inability to close eye tightly), went to bed. 3/12-6:30am weakness on left side progressed- eye wouldn?t blink/close, asymmetric smile...called clinic and was asked to come in. My primary saw me and sent me to the ER. They looked in my ear and Diagnosed me with Ramsay Hunt Syndrome (shingles outbreak in ear/ impacting facial nerves causing acute paralysis) on 3/12/2021 after initial symptoms began on 3/6/2021. I was put on 1000mg of valacyclovir 3x day and 60mg prednisone for 1 week each. Moderately-Severe Paralysis remains as of 3/24/2021.
30 2021-03-23 oropharyngeal discomfort Patient sent to emergency department from nearby vaccine clinic with tachycardia (HR 138). She recei... Read more
Patient sent to emergency department from nearby vaccine clinic with tachycardia (HR 138). She received her second dose of the Pfizer vaccine approximately 45 minutes prior to arrival to ED. On arrival to ED she also had abnormal sensation in the back of her throat, change in her voice, and a new rash which developed few minutes prior to arrival. At this point, with signs and symptoms c/w anaphylaxis, she was given IM epinephrine, solumedrol, Benadryl, and famotidine. Symptoms improved entirely after 3-hour observation period and she was discharged home on EpiPen, prednisone, Benadryl, and famotidine.
30 2021-03-23 vision blurred, dry mouth, thirst After the first 10 minutes, vision blurry and anxious, felt like she was going to pass out. Pt una... Read more
After the first 10 minutes, vision blurry and anxious, felt like she was going to pass out. Pt unaware if she lost consciousness. then had emesis. Appears pale and dry in oral mucosa. 1910. Now with complaints of stomach cramps. Drinking water. Emergency team called and patient refused transport to ER.
30 2021-03-25 eye movement disorder pt had severe anxiety attack after receiving the vaccine. pt was very tense and not breathing with e... Read more
pt had severe anxiety attack after receiving the vaccine. pt was very tense and not breathing with eyes rolled back into her head. mother stated she had had an attack at the hospital giving blood before bc of severe fear of needles. 911 was called and she was taken to the hospital
30 2021-03-25 eye swelling, eye irritation, bloodshot eyes Eye irritation in both eyes. Eyes became irritated, red, and swollen. Irritation went away 1 week af... Read more
Eye irritation in both eyes. Eyes became irritated, red, and swollen. Irritation went away 1 week after receiving 1st dose. Eye irritation repeated after 2nd dose and stayed for 1 week. Several weeks later eye irritation still occurs from time to time.
30 2021-03-25 swollen tongue, lip swelling When I first got the vaccine I had a flush reaction (felt like I had an IV and they had just flushed... Read more
When I first got the vaccine I had a flush reaction (felt like I had an IV and they had just flushed the IV). I felt dizzy. It went away quickly. 5 mins later I had diarrhea. I was also feeling post nasal drip, itchy throat, my chest had a burning sensation from the inject arm towards the middle of my chest. Throat was closing and tongue and lips were swelling. Entire body was itchy.
30 2021-03-26 mouth tingling Tongue tingling, itching, hives
30 2021-03-26 tongue itchiness, lip itchiness Hives, itchiness, swollen and itchy tongue/lips, mild wheezing. I took zyrtec before I noticed sympt... Read more
Hives, itchiness, swollen and itchy tongue/lips, mild wheezing. I took zyrtec before I noticed symptoms beginning, which probably helped. The next day, as the zyrtec started to wear off, my tongue/lips began to feel itchy and mildly swollen again. I called my doctor but did not go to the hospital
30 2021-03-27 ear pain Fever, body aches, headaches, ear aches, swollen arm, chills, lethargic, cough
30 2021-03-27 ringing in ears complete hearing loss in my left ear for about four hours/ noticed but undocumented hearing loss; he... Read more
complete hearing loss in my left ear for about four hours/ noticed but undocumented hearing loss; headache; chills; hangover feeling; incredibly loud ringing in left ear/ intermittent throughout the day, lasting for several hours at some points/ constant dull ringing/ tinnitus/ ringing in both ears; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 22Mar2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable Other Health Professional (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot EN6201) via intramuscular at left deltoid on 19Feb2021 at 14:30 (30-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included bipolar disorder, ADHD, depression, and low Vit D. The patient had no COVID prior vaccination. There were no known allergies. Concomitant medications included lamotrigine (LAMICTAL) from 2016 and ongoing for bipolar, sertraline hydrochloride (ZOLOFT) from 2020 and ongoing for Bipolar, amfetamine/dexamfetamine (reported as amphetamine/dextroamphetamine salt extended) from 2015 and ongoing for ADHD and depression, Vitamin D3 from 2020 and ongoing for low Vit D, and cyanocobalamin (VITAMIN B12). The patient did not receive other vaccine in four weeks. Facility type was school or student health clinic; vaccine was administered at military facility. On 20Feb2021 at 21:00, patient had the normal headache, chills, "hangover feeling" in addition to an incredibly loud ringing in her left ear after her first dose. The ringing was intermittent throughout the day, lasting for several hours at some points. The intensity of it has subsided but there seems to be a constant dull ringing in her left ear now. She also had some weird effects with her medications the two days following her first dose. Not entirely sure if they're related but her medication seemed to be ineffective on Saturday and have little effect on Sunday. Severe tinnitus began around 10:00 (as reported) following her first vaccination, resulting in complete hearing loss in her left ear for about four hours. After that the severe ringing was intermittent for about five more hours. She now has ringing in both ears since, with noticed but undocumented hearing loss. There were no further complications after the second dose. The second dose (batch/lot number EN6205) was received via Intramuscular at left deltoid on 12Mar2021 at 14:00. The adverse events did not result in emergency room visit or physician office visit. The patient did not test COVID post vaccination. No therapeutic measures were taken as a result of the events. The outcome of tinnitus was not recovered; outcome of other events was recovered with sequel.
30 2021-03-28 dry throat Weak, dry throat, SOB. Evaluated by EMS-Cleared.
30 2021-03-29 lip swelling, eye swelling 1/14 vaccination About 5 days later, I noticed swelling on my eyes, mild. 6 days later, I woke up, ... Read more
1/14 vaccination About 5 days later, I noticed swelling on my eyes, mild. 6 days later, I woke up, my whole face was swollen. No other symptoms, just swelling of face to include lips, eyes, cheeks. \I went to the ER that Thursday. Friday I saw the allergist via telehealth. Didn't know if due to vaccine. Benadryl was not helping. Dr. put me on oral steroids for 7 day taper. It cleared up the swelling.
30 2021-03-29 lip swelling, lip pain after sitting in the 15 mins observation room; I began to feel itchy on my cheeks. Upper lip began t... Read more
after sitting in the 15 mins observation room; I began to feel itchy on my cheeks. Upper lip began to feel swollen/tender. I notified volunteer nurse who took vitals and gave cetirizine. Afterwards, I began to be itchy/red hives all over body. This did not result in an ER visit.
30 2021-03-29 ringing in ears Tinnitus
30 2021-03-30 swollen tongue Patient complained of swollen tongue, no shortness of breath, no chest tightness. Paramedics arrived... Read more
Patient complained of swollen tongue, no shortness of breath, no chest tightness. Paramedics arrived on scene and gave a Benadryl shot. Patient will be sent out to a nearby hospital because symptoms are not relieved.
30 2021-03-30 visual impairment, hearing loss Vision darkening Hearing diminished Bradycardia Diaphoresis Junctional arrythmia
30 2021-03-31 eye swelling Patient came in this evening from visit with her doctor with a prednisone dospak, 6 day... loratadin... Read more
Patient came in this evening from visit with her doctor with a prednisone dospak, 6 day... loratadine tabs and a albuterol inhaler. Stated her right side of her face went numb and her right eye began to swell. also stated her skin was blotchy all over and later in the evening (3/31) had very labored breathing.
30 2021-04-02 ringing in ears, tunnel vision Patient 30 y/o Female, received her first dose of Pfizer COVID-19 vaccination (Lot #ER8729, exp. 07/... Read more
Patient 30 y/o Female, received her first dose of Pfizer COVID-19 vaccination (Lot #ER8729, exp. 07/31/21) on 4/3/21 around 11:10am. While in the post-vaccination observation area, notified EMTs around 11:15am that she felt lightheaded, sweaty, nauseous, dizzy, had ringing in her ears, fainting, and was experiencing "tunnel-vision." EMT and responded to . had a BP of 108/60 at 11:15am. Co-lead , RN attended to after being notified. Upon assessment, is arousable, alert and oriented x 4, verbally responsive but sluggish to respond. No signs or symptoms of respiratory distress. Medical history of asthma, phobia of needles, not currently taking any meds. 911 was called. 911 instructed RN to not give any food or drink to . stated she was feeling a "little better" around 11:22am; appeared sweaty and reported mild dizziness and lightheadedness. At 11:25am, had a HR of 68 and a RR of 18 and O2 SAT OF 97%. At 11:28am reported mild lightheadedness; her symptoms of sweatiness and dizziness had resolved. At 11:30am the AMR Paramedics arrived, as well as the Fire Dept. refused to be taken by ambulance to the ER. Paramedics monitored at the site for the next 30 mins. in the post-vaccination observation area. Provided education to to notify next time during vaccination that she has a history of fainting from vaccinating. left the site on her own will; accompanied by her spouse, unassisted, no complaint of nausea, fatigue, and ambulates with steady gait. VAERS report submitted. Confirmation #
30 2021-04-03 mouth tingling Experienced light headed was, dizziness, nausea, and tingling sensation of the tongue. Immediately n... Read more
Experienced light headed was, dizziness, nausea, and tingling sensation of the tongue. Immediately notified nurses who put me on a monitor to track O2 and BP. BP elevated but within normal range. Provided apple juice to raise blood sugar and ordered to remain until symptoms passed. Symptoms resolved within 15 minutes. Since the event have felt elevated levels of fatigue.
30 2021-04-04 mouth numbness Patient presented in obs area after receiving 2nd dose, started complaining of left arm injection si... Read more
Patient presented in obs area after receiving 2nd dose, started complaining of left arm injection site numbness that radiated down to left hand, also complained of tongue numbness, vitals: 156/101 right arm, HR 91, SpO2 98% room air, respiratory rate 22, 0/10 pain. Pt began feeling worse, assessed lung sounds, expiratory wheezing noted, pt had home dose inhaler on hand, self-administered 2 puffs of albuterol HFA inhaler, states relief, pt did not complained of respiratory distress at any time. EMS left with patient at 1140 to local hospital, pt alert, oriented and cooperative at all times. Left alert and oriented, in no apparent distress. No epi or benadryl administered.
30 2021-04-04 sensitivity to light, extreme sound sensitivity, smell distorsion Dose 1: -Minor headache and fatigue for 3-4 days Dose 2: -Day 0 (date of vaccine) = Pain in planta... Read more
Dose 1: -Minor headache and fatigue for 3-4 days Dose 2: -Day 0 (date of vaccine) = Pain in plantar of left foot (cramp within 30 minutes of vaccine) -Day 1 Post Vaccine = Fatigue, Muscle aches all over body, pain in left foot continued same duration/pain level as arm where vaccine was administered, sever flu-like symptoms -Day 2 Post Vaccine = Felt fine mostly, slight fatigue -Day 3 Post Vaccine = Severe Migraine with light/sound/smell sensitivity, fatigue, nausea, vomiting -Day 4 Post Vaccine (reporting date) = Minor headache
30 2021-04-05 mouth tingling Tongue feels heavy, left side numb from toes to left shoulder.
30 2021-04-06 blindness Within minutes of receiving the injection I began to feel dizzy. My heart rate quickly began to drop... Read more
Within minutes of receiving the injection I began to feel dizzy. My heart rate quickly began to drop according to my Fitbit. My heart rate is normally around 68. When the dizziness began I noted my heart rate dropped to 57 then 52 within seconds. The dizziness continued to get worse over the next minute or so until I completely lost my vision. One of the workers brought me water and within a minute of drinking my vision began to come back slowly. After sitting for another 10-15 after regaining my vision I felt better. I am concerned about getting my second dose of vaccine after this first experience. Please advise.
30 2021-04-06 taste impairment Metal taste in mouth
30 2021-04-06 eye pain Moderate to severe headache, neck pain, chills, painful eyes, nausea, fever of 101.5-102.0 for first... Read more
Moderate to severe headache, neck pain, chills, painful eyes, nausea, fever of 101.5-102.0 for first 24 hours.
30 2021-04-06 mouth discomfort, tongue disorder Tiny bumps on my tongue and a burning sensation since friday 4/2 Uncomfortwhem i eat
30 2021-04-07 oropharyngeal discomfort Patient developed difficulty swallowing, throat discomfort, heart racing and mild dizziness within 1... Read more
Patient developed difficulty swallowing, throat discomfort, heart racing and mild dizziness within 15 minutes of receiving vaccine. Was observed, BP and HR elevated above normal range, pulse ox 100%. About 10 minutes after reaction started given 60 mg of Allegra and patient reports improvement. She was released at her request to return home since she improved.
30 2021-04-08 smell distorsion Phantom smells- parosmia.
30 2021-04-08 sensitivity to light Worst migraine I have ever had. Aimovig usually prevents them from becoming severe, as well as takin... Read more
Worst migraine I have ever had. Aimovig usually prevents them from becoming severe, as well as taking 1 sumatriptan at onset of migraine. It took 6 hours, 2 sumatriptan pills, sudafed, ibuprofen, and heat to get the migraine down to its usual pain level. Light was much more painful than usual as well. Usual migraine pain for me is a 6 on the pain scale. This migraine was a 9.
30 2021-04-09 deafness I'm having spells of dizziness, hearing loss, and headaches.
30 2021-04-10 mouth numbness 30 min after vaccine: numb lips and tongue 45 min after vaccine: above symptoms + numb palate and lu... Read more
30 min after vaccine: numb lips and tongue 45 min after vaccine: above symptoms + numb palate and lump in throat 60 minutes after: above symptoms + Numb bilateral 4th and 5th fingers, hives on chest
30 2021-04-10 lip swelling Swollen lips, starting morning after injection, lasting
30 2021-04-10 feeling of choking Directly after getting the shot 5/9/2021 4:05pm - current I've had a sore throat, started as tinglin... Read more
Directly after getting the shot 5/9/2021 4:05pm - current I've had a sore throat, started as tingling and then moved to pain after a few hours Really bad Migraine from 5/10/2021 8:30am - 3:00pm Bad diarrhea every time I eat 5/11/2021 5:30 am - current
30 2021-04-10 swelling of eyelid Eyelid swelling that has occurred about 4-5 times. Initial event was the following week after the se... Read more
Eyelid swelling that has occurred about 4-5 times. Initial event was the following week after the second dose; bilateral eyelid swelling (one upper lid, other lower lid). Subsequent episodes are unilateral with left side occurring greater than right. Usually resolves in about 5 hours. Most recent episode was the largest it has been and it has persisted beyond 12 hours. No other associated swelling, no eye pain, no itching or irritation.
30 2021-04-11 swollen tongue After injection pt was escorted by RN to observation area. In route, patient passed out. Color becam... Read more
After injection pt was escorted by RN to observation area. In route, patient passed out. Color became dusky. Spo2 was 88-100 %. Dr ordered Epi Pen to be administered to left thigh at 1258. EMS was notified and patient taken to Hospital. Upon arrival to ED pt reports she became suddenly dizzy then woke up in the ED. She experienced chest tightness, sore throat, tongue swelling. Second epi was given in the ED. Developed muscle stiffness in the ED.
30 2021-04-12 eye pain Very strong headaches causing nausea for 14 days. No over the counter pain relievers helped. I tried... Read more
Very strong headaches causing nausea for 14 days. No over the counter pain relievers helped. I tried ibuprofen, acetaminophen, and Excedrin Migraine. The headache was usually also accompanied by pain behind my eye.
30 2021-04-12 mouth tingling Patient had tingling in mouth, numbness, then itchiness within 15 minutes of vaccination.
30 2021-04-13 mouth numbness Numbness spead to entire left side of face. Possible bells palsy. Mouth slightly drooped. Went to pr... Read more
Numbness spead to entire left side of face. Possible bells palsy. Mouth slightly drooped. Went to primary dr. Getting better but still numbness in front teeth area today.
30 2021-04-13 mouth tingling mouth tingling Tx: none, Resolved 1/27 -> 2nd dose received s problem
30 2021-04-13 mouth tingling I was about 5 weeks at time of vaccine. After vaccine tongue started getting tingly I was give a ba... Read more
I was about 5 weeks at time of vaccine. After vaccine tongue started getting tingly I was give a banana about 5 minutes it did go away. I dint exp this symptom with the tongue after Dose 2. My (estimated date of delivery 10/1).
30 2021-04-14 mouth numbness numbness in tongue
30 2021-04-14 mouth numbness POST VACCINE PT DEVELOPED FINGERTIP AND PERIORAL NUMBNESS WITH SOME INVOLVEMENT OF HER TONGUE. NO OT... Read more
POST VACCINE PT DEVELOPED FINGERTIP AND PERIORAL NUMBNESS WITH SOME INVOLVEMENT OF HER TONGUE. NO OTHER ALLERGIC REACTION OR VASOVAGAL SYMPTOMS NOTED. TRANSPORTED TO MED OBS AT 1325. VITALS OBTAINED AND MONITORED. SYMPTOMS RESOLVED. PT RELEASED TO HOME BY SELF AT 1404 . VITALS AS FOLLOWS: 1332 BP 131/85 HR 73 SPO2 98 1339 BP 143/86 HR 80 SPO2 97 1346 BP 138/94 HR 83 SPO2 99 1353 BP 122/83 HR 81 SPO2 97 1358 BP 128/89 HR 78 SPO2 96
30 2021-04-14 ringing in ears Severe chills, could not get warm at all. Headache, existing tinnitus got significantly more intense... Read more
Severe chills, could not get warm at all. Headache, existing tinnitus got significantly more intense at painfully high pitches. Entire body ached and was extremely fatigued
30 2021-04-14 tongue disorder Soon after receiving shot, PT experienced dizziness and felt like she was going to pass out, medical... Read more
Soon after receiving shot, PT experienced dizziness and felt like she was going to pass out, medical team arrived to assess. PT was conscious but shortly thereafter, she had a tonic-clonic seizure. This lasted about 2 minutes, then she was post-ictal for about a minute. Then PT was able to answer questions appropriately and knew where she was. V/S were normal including a BP of 105/70, SPO2-100%, HR-70. EMS was called to transport to ER. Over the next several minutes, PT felt dizzy and tingly. She remained stiff in extremities and had a hard time verbalizing, trying to say that her tongue felt stiff. When EMS arrived, they took her blood sugar, which was 120. She was then taken to ER for further evaluation.
30 2021-04-15 hearing loss, ringing in ears pt has anxiety and fear of needles after vaccine felt flushed and given water while sitting in chai... Read more
pt has anxiety and fear of needles after vaccine felt flushed and given water while sitting in chair, pt then felt hearing fade and ringing in ears placed in wheelchair and brought back to OBS for evaluation, pt stood and transferred to stretcher laying down feeling better when laying in bed. vs as noted dr at bedside reviewed vs and assesssed patient. pt sat up to dangle to standing without complaints of symtpoms feeling better. ambulated to exit at 1415 without diffiuclty vs 1400 bp 144/79 hr 71 rr 20 o2 97 1405 bp 148/95 hr 85 rr 18 o2 99 1410 bp 143/89 hr 77 rr 18 o2 99
30 2021-04-15 hearing loss about 10 mins after receiving vaccine, started feeling dizzy, and "swimmy" (tunnel vision, auditory ... Read more
about 10 mins after receiving vaccine, started feeling dizzy, and "swimmy" (tunnel vision, auditory fading), assisted to floor by staff, feet placed on chair. assisted to stretcher, placed in Trendelenburg, taken to obs, bp 107/70 hr 58 rr 18 sats 100% on ra. clamminess noted. water and snack provided, feeling better, sitting up vss, bp maintained. standing bp 118/81 15 mins later, other vss. escorted with sig other to exit with no issues after stating fully recovered
30 2021-04-15 smell distorsion, taste disorder After taking my first Pfizer vaccine I started to have altered taste and smell. I originally had cov... Read more
After taking my first Pfizer vaccine I started to have altered taste and smell. I originally had covid 19 in December and did lose my taste and smell but it had come back 100% after 2 weeks. I had my taste and smell back and then went to go get vaccinated on 2/17/21. Friday 2/26/21 when I had ate my lunch the chicken tasted old and like it had gone bad. I thought that I had just had bad food. Turns out that was the first time that my taste seemed off. The next time I ate chicken a couple days later it tasted rancid and I had to spit it out. This started with chicken and then progressed to beef, pork, any meat. A week later it progressed to where garlic started to taste bad. Meat and Garlic have the same rancid smell to them. It then progressed to my bowel movements smelling the same way. Then progressed to always having the bad taste in the back of my mouth. About 2-3 weeks ago tap water started to smell very strongly of chemicals. Now it has progressed to Meat, Garlic, onions, or anything in garlic family, strawberries, zucchini, peanut butter, chemical smell of water, coffee, and then just foods here and there that do not taste terrible but do not taste good either. The only foods that taste completely normal are sweets like icecream or cake. My diet is now consisting of protein bars, protein shakes, salads, chips, cheese, and sweets. It?s been challenging especially since garlic is put in 90% of all food products it feels like. If I open the container of garlic powder it can make me gag until I vomit if I smell it long enough. I did mention this to my Primary Care Doctor. She stated that she would be willing to refer me to a specialist if my symptoms persist into June or so. Right now not only are my symptoms persisting but worsening every week. I?m concerned that I will eventually run out of foods I can eat. These symptoms are still ongoing. It is depressing to deal with and challenging.
30 2021-04-15 ringing in ears 15 min after the injection I rose to leave and my leg seemed to be ?asleep? with pins and needles. W... Read more
15 min after the injection I rose to leave and my leg seemed to be ?asleep? with pins and needles. When I got in my car a had a sharp pain in my left shoulder blade. Within 5 min the ?asleep? feeling of pins and needles spread all over my body. This was accompanied by occasional sharp stabbing pains. By evening the feeling had progressed to numbness and cold in my left hand. The cold feeling stayed in my left hand only. The symptoms continued for two days. On day three my tinnitus acted up. Unsure if I should get the second dose.
30 2021-04-15 ringing in ears Extreme nausea, vomiting, fast heart beat, dizzy, weak feeling, tingling feet, headache, ringing in ... Read more
Extreme nausea, vomiting, fast heart beat, dizzy, weak feeling, tingling feet, headache, ringing in ears. On and off heavy chest
30 2021-04-17 ear congestion All symptoms started within 1-3 hours of receiving vaccine. Nausea, body aches/sore, tired, chills, ... Read more
All symptoms started within 1-3 hours of receiving vaccine. Nausea, body aches/sore, tired, chills, loss of appetite, skin flushed appearance, sinus issues (ears draining, nasal congestion). Fever and more intense body aches (all past injuries and even my bones hurt. It hurt to move, sit, and laydown) started that evening. Next day: Fever, chills, intense body aches (painful to move), nausea (on and off throughout the day), skin flushed appearance, headaches. Day 3 (Sunday/day of form submission): Body aches and nausea (on/off) continue. Treating symptoms with ibprophen 600mg, soup, electrolytes, and rest.
30 2021-04-17 ear itchiness reported "itching throat & internal ear canals" without any other symptoms; no respiratory compris... Read more
reported "itching throat & internal ear canals" without any other symptoms; no respiratory comprise ; no associated dypagia /tongue swelling; no Tx; advised to wait additional 15 mins for observation. after 15 mins. no change in SX. Husband drove client off lot; pt. reports she usually takes claritin; is going to store to purchase.
30 2021-04-18 eye swelling Swelling on right side of face; right eye swelled shut; labored breathing; red splotches on face and... Read more
Swelling on right side of face; right eye swelled shut; labored breathing; red splotches on face and arm; extreme fatigue and fog; extreme fatigue and fog; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 16:45 (Batch/Lot number was not reported) at a single dose for covid-19 immunisation. The patient medical history was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with Covid-19 prior vaccination, and has not been tested for Covid-19 since vaccination. Patient was not pregnant at time of vaccination. Concomitant medications reported included bupropion hydrochloride (WELLBUTRIN XL) for unspecified indication, start and stop date not reported. On 31Mar2021 17:30, patient experienced swelling on right side of face, right eye swelled shut, labored breathing, red splotches on face and arm, and extreme fatigue and fog. Therapeutic measures were taken as a result of swelling on right side of face, right eye swelled shut, labored breathing, red splotches on face and arm and extreme fatigue and fog. The adverse events resulted on emergency room/department or urgent care. Patient received steroids, inhaler and allergy medicine. Outcome of the event labored breathing and extreme fatigue and fog (feeling abnormal) recovered on unspecified date, while others were recovering. The vaccine was administered in a Pharmacy or Drug Store. Follow up attempts are needed. Information on lot/batch number was requested.
30 2021-04-18 swollen tongue tongue swelling and throat pain
30 2021-04-18 ringing in ears, ear discomfort Monday I received my Pfizer vaccine. Next day Tuesday morning 4/13/21 woke up to Muffled clogged ear... Read more
Monday I received my Pfizer vaccine. Next day Tuesday morning 4/13/21 woke up to Muffled clogged ears, vertigo, brain fog , confused , feeling intoxicated, loosing balance , tinnitus . So far I have been presenting these signs all week . Went to see a Provider on Friday was told it could be an adverse reaction to the vaccine
30 2021-04-19 hearing loss, ringing in ears Mild tinnitus SEVERE vertigo (leading to a trip to Urgent Care where they prescribed meclizine and ... Read more
Mild tinnitus SEVERE vertigo (leading to a trip to Urgent Care where they prescribed meclizine and home Epley maneuvers, diagnosis of BPPV). Nausea Muffled hearing in left ear As days progressed- vertigo lessened, no just constant but slight dizziness and fogginess. Muffled hearing persists. Some relief was found with osteopathic manipulations of the neck. Began taking vitamin D, vitamin B complex, zinc, vitamin C, and magnesium.
30 2021-04-19 lip swelling, swollen tongue Patient is a 30 y.o. female Patient received Covid vaccine at immunization site. During 15 minutes... Read more
Patient is a 30 y.o. female Patient received Covid vaccine at immunization site. During 15 minutes post-monitoring period: Please see additional note below regarding counseling points, monitoring, and interventions done. COVID-19 Vaccine Adverse Reaction Reaction due to: First dose of vaccine Symptoms: Difficulty swallowing, Throat tightness, Dizziness/Lightheadedness, Shortness of breath, Lip and/or tongue swelling How long after administration did the symptoms start?: Immediately (within 15 minutes) Interventions: Additional monitoring, Education provided regarding symptoms and home care, Other (comment) (pt used her own epi pen with improvement, given 50mg oral diphenhydramine) If reassessed, patient's condition: Improved (improved with epi pen) Disposition: Education and follow-up phone number (given follow-up precautions) Pt experienced throat and tongue swelling 10-12 minutes after Pfizer COVID19 vaccine that improved with the use of her own epinephrine pen. Symptoms rapidly improved. Pt was given 50mg oral diphenhydramine. BP 136/86 hr 93, SaO2 100%. Was counseled on when to seek emergency medical attention. I advised pt to be evaluated by allergy specialist prior to her second dose and pt says she already has one via facility. Has her fiance to drive her home. 30 min observation with periodic vitals. 11:40a BP 120/76 11:45a BP 126/70 HR 86, SaO2 99%
30 2021-04-19 lip swelling On Tuesday, April 20, 2021 client received her second dose of Pfizer COVID vaccine (LOT #EW0171 , EX... Read more
On Tuesday, April 20, 2021 client received her second dose of Pfizer COVID vaccine (LOT #EW0171 , EXP 7/2021) at approximately 3:40pm. Patient has no history of allergic reaction to a vaccine before and was to be observed for 15 minutes after administration of her vaccination. While in Observation Area, patient reported she sensation of having a "mild swollen lip" approximately 5 minutes after vaccine administration. Lead RN was alerted and assessed client if she had a reaction to her first dose to which the client stated she does not recall. Lead RN & client assessed her arms and legs for any signs of rash to which none was found. Client denied any signs of other immediate allergic reactions including pruritus, flushing, dizziness or light-headedness. EMT & EMT offered to take vitals to which the client denied. Lead RN offered 50mg Diphenhydramine to which the client also denied. Client was given water and observed for an additional 15 minutes. No further interventions indicated. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site at approximately 4:30pm with a steady gait.
30 2021-04-19 vision blurred About 4-5 minutes after receiving my vaccine, my entire body got flush, and I almost passed out. I w... Read more
About 4-5 minutes after receiving my vaccine, my entire body got flush, and I almost passed out. I was able to stay conscious, but my sight became extremely blurry. I was not able to see well for the next 4 hours or so afterwards. I also developed a vertigo, and needed to take 2 days off of work, plus the entire weekend to begin to recover. The only thing that helped the headache, my eyes, and my head feel somewhat normal was to sleep. I slept on and off for most of the following 5 days after my vaccine.
30 2021-04-20 ear discomfort, ringing in ears Right ear tinnitus- whooshing heartbeat sound and pressure
30 2021-04-20 hearing loss Whooshing, heartbeat hearing in right ear
30 2021-04-20 mouth tingling, swollen tongue TONGUE SWELLING AND TINGLING, THIS HAPPENED ON THE FIRST DOSE AS WELL, CARRIES EPI PEN FOR UNKNOWN A... Read more
TONGUE SWELLING AND TINGLING, THIS HAPPENED ON THE FIRST DOSE AS WELL, CARRIES EPI PEN FOR UNKNOWN ALLERGY. NO OTHER S/S VSS NO SOB OR CHEST PAIN . MEDICAL DOCTOR ON SITE NO TRANSPORT TO HOSPITAL NECESSARY ADVISED TO CONSULT WITH ALLERGIST MONITORED X30 MIN.
30 2021-04-21 ringing in ears Persistent loud tinnitus from around time of shot up to and including now.
30 2021-04-22 loss of taste, mouth numbness 04/20/21 at 17:30 hours I received the vaccine 04/21/21 at 13:00 hours I noticed I have no taste in ... Read more
04/20/21 at 17:30 hours I received the vaccine 04/21/21 at 13:00 hours I noticed I have no taste in my palate and my mouth is numb and there is pain behind my right ear 04/22/21 at 6:09 hours upon brushing my teeth I noticed I have facial paralysis. That same day I called where they administered the vaccine (Pharmacy) and they told me to go to the doctor. I went to the medical center
30 2021-04-22 swollen tongue Event: Tongue is slightly swollen and very raw. The event was noticed approx 8 hours after the vacci... Read more
Event: Tongue is slightly swollen and very raw. The event was noticed approx 8 hours after the vaccination and persists into day 3. No treatment was needed, however it has impacted the ability to consume foods normally. I have resorted to eating soft foods and room temperature to avoid further irritation. Of note, the sensation has not led to loss of taste at the time of the report.
30 2021-04-23 swollen tongue About 2 minutes after the shot was administered I felt as if I was going to lose consciousness and m... Read more
About 2 minutes after the shot was administered I felt as if I was going to lose consciousness and my airways and tongue began to swell. I immediately took Prednisone and benadryl. I had premedicated before getting the shot due to an increased risk of allergic reaction given my history of anaphylactic responses to other allergens. I have never reacted to a vaccine before. The pre-medications allowed me to treat the reaction with benadryl, prednisone, and albuterol without the need for an Epi pen. I started with 10mg of prednisone and 12.5mg of benadryl (chewable). I took additional doses every 15 min as the reactions continued. I had another wave of reaction where I felt like I would lose conciseness 15 minutes after the shot was administered. I went home after 30 minutes and continued to monitor the reactions and take additional interventions including: benadryl, prednisone, nasal cromolyn sodium, albuterol, Pepcid AC, & oral cromolyn sodium. At 4:45pm I developed hives and treated with cromolyn sodium applied directly to the hives. Digestive upset started around 8pm.
30 2021-04-23 ringing in ears, ear discomfort On April 15th all day starting around 10:00am: 1) Fatigue, continued all day 2) Ear fullness, ringin... Read more
On April 15th all day starting around 10:00am: 1) Fatigue, continued all day 2) Ear fullness, ringing, my tinnitus was loud all day, ended before next day 3) Mild injection site pain, all day On April 16th: 1) fatigue, which ended by next day 2) Mild injection site pain, all day, ended by next day
30 2021-04-23 ringing in ears Fatigue and chills since the day after vaccination. Tight chest and shortness of breath by on and o... Read more
Fatigue and chills since the day after vaccination. Tight chest and shortness of breath by on and off since 4/9, about 3x/week. Ringing and echo in ears started occurring 4/18 or so, about 2x/ day
30 2021-04-24 eye swelling, swelling of eyelid, bloodshot eyes, lacrimation increased, eye pain I began to experience wheezing in my chest about 12 hours after vaccine . After 14 hours, I took cla... Read more
I began to experience wheezing in my chest about 12 hours after vaccine . After 14 hours, I took claritin-d and singulair to help my breathing. Within 15 hours, my eyes were red and began to ache and swell. After 22 hours, my eyeslids (upper and bottom) were swollen , teary, and had crust around the eyelids. I also experienced a headache so I took some tylenol. Headache has mostly subsided but my eyes are still achy and swollen.
30 2021-04-24 eye swelling chills; sneezing; congestion inside her face; her eyes and cheek bones were swollen; her eyes and ch... Read more
chills; sneezing; congestion inside her face; her eyes and cheek bones were swollen; her eyes and cheek bones were swollen; vomiting everything; hasn't felt good; hives on the body; facial swelling; nausea; headache; fever/She still has a fever of 100.2 everyday/99.5F; body aches/lower back body aches; fatigue; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Left Arm on 31Mar2021 12:30 (Batch/Lot Number: EW0150) as SINGLE DOSE for covid-19 immunisation, patient wanted to be vaccinated against COVID. Medical history included weak immune system form 2016 and ongoing, states she started to have a low immune response a couple of years ago, but provided 2016 as the start year. Caller stated she did not have a medical diagnosis, but had a very low immunosuppressive response. Mentioned she had a low immune system. Family Medical History Relevant to AE(s): States her mom is allergic to penicillin. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional administered vaccines. No prior vaccinations (within 4 weeks). The concomitant drugs not reported. Then she developed nausea on 31Mar2021, headache on 31Mar2021, chills on an unspecified date and a fever on 31Mar2021 and this has continued for 7 days. She was concerned about getting her second dose of the vaccine and wants to know how long these side effects could last. Use of fever reducing drugs and pain relievers. Caller states she still has a fever, body aches on 31Mar2021, headache, chills, and nausea. This was her first dose and states she was confused because she knows symptoms shouldn't last longer than 2-3 days. She still has a fever of 100.2 everyday. She woke up with a fever and headache today. On Sunday (04Apr2021), she had intense facial swelling and hives on the body. Patient had facial swelling that day, which resolved. She was also sneezing. She states she didn't know what to do. Caller asked was her body going to collapse if she gets the second vaccine. Patient wondering if she should go to the hospital. Stated everyone says the second dose was way worse. She already filled out a safety report online yesterday. However, she was calling to speak to someone today to see what to do. The vaccine was given on 31Mar2021 at 12:30 and by 6 o'clock she stated to have symptoms. Caller said she usually wakes up in the day and feels fine, but by mid afternoon she gets a fever of 100.2F that lasts a while. Right now it's 99.5F, but it also did not go above 100.2F. She experiences lower back body aches every time she has a fever. Her nausea was worse on the day of the vaccine. She couldn't even keep water down. She was vomiting everything. Her headache was really bad the first day, but now was mild, and ongoing. With the facial swelling she experienced sneezing, congestion inside her face, and her eyes and cheek bones were swollen. She also got hives. The hives appeared on armpit and neck. States she still had a couple, but was unsure if they are still hives. She also had fatigue on 31Mar2021 that had been ongoing since the vaccine. She just hasn't felt good since Wednesday. Caller treated her symptoms with Ibuprofen for fever, headache, and body aches. She was also resting to help with the symptoms. Outcome reported as iInitially confirmed as they have improved. Mentioned there are only like two there now. She has not had any new hives since 04Apr2021. Caller stated her question. Was that she just want to talk to someone about what was going on and this was the 7th day of fever and other symptoms from the Pfizer Vaccine that she has had since day 1; states she needs to know if she should go to the ER or if she should be taking the 2nd dose of the Pfizer Vaccine if she has this serious reaction to the 1st dose; caller states she has never had covid before and states she has not had covid at least not that she knows of. Caller aware cannot provide treatment recommendations or medical advice; states she does not have a HCP and what to do if she does not have a HCP provider. Reporter stated this was the 7th day of fever and other symptoms from the Pfizer Vaccine that she has had since day 1; caller stated she had never had covid before and states she had not had covid at least not that she knows of. All events did not require a visit to Emergency Room or Physician's Office. The outcome of event facial swelling was recovered on 04Apr2021, of chills, sneezing, congestion inside her face, her eyes and cheek bones were swollen, vomiting everything and hasn't felt good was unknown, of fever, body aches and fatigue was not recovered, of other events was recovering, No follow-up attempts are needed. No further information is expected.
30 2021-04-24 drooping eyelid Right eye ptosis that began 24 hours after vaccine administration and had not resolved 4 months late... Read more
Right eye ptosis that began 24 hours after vaccine administration and had not resolved 4 months later; This is a spontaneous report from a contactable other hcp (patient). A 30-years-old non pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 06Jan2021 16:00 (at the age of 30-years-old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history was none. No known allergies. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; intrauterine contraceptive device (PARAGARD) taken for an unspecified indication, start and stop date were not reported. No Covid prior vaccination. No other vaccine in four weeks. It was reported that, Right eye ptosis that began 24 hours after vaccine administration (Jan2021) and had not resolved 4 months later. The patient had Planned surgery. AE resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. On 23Mar2021, the patient had Covid antigen tested post vaccination with nasal swab which was negative. Outcome of the event was not recovered. Information about the Lot/batch number has been requested. ; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, eyelid ptosis cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
30 2021-04-24 hearing loss, ringing in ears Severe tinnitus in both ears for at least a week, maybe more; Some difficulty hearing in normal/quie... Read more
Severe tinnitus in both ears for at least a week, maybe more; Some difficulty hearing in normal/quiet circumstances; fever and felt like I could not get out of bed for about 8 hours the day following my vaccine; This is a spontaneous report received from a contactable other healthcare professional. This reporter reported information for both mother and fetus/baby. This is the mother report. A 30-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22Mar2021 10:00 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Patient received the first dose on 01Mar2021 10:00 with lot number EN6202. Medical history included penicillin allergies. The patient's concomitant medications were not reported. The patient experienced Severe tinnitus in both ears for at least a week, maybe more. Some difficulty hearing in normal/quiet circumstances. Took me a while to identify the pattern and determine/test that it wasn't from listening to headphones or sound issues using my phone or laptop. Patient had a fever and felt like could not get out of bed for about 8 hours the day following vaccine from 26Mar2021 12:00. Outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : same reporter/drug, different patient/event(baby case)
30 2021-04-24 drooling had symptoms like something caught in her throat; throwing up; diarrhea; severe allergic reaction; F... Read more
had symptoms like something caught in her throat; throwing up; diarrhea; severe allergic reaction; Feels like she has a cold; Runny Nose; A lot of Saliva and Mucous Coming up; A lot of Saliva and Mucous Coming up; Thinks she was panicking; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 12:50 (Batch/Lot Number: EP7533) as single dose for Covid-19 immunisation. Medical history included ongoing issues with stomach she has had for a long time, ongoing bad migraines she has had since she was about 14 years old, ongoing panic attacks she has had since 16 years old, ongoing anxiety she has had since 16 years old, ongoing acid reflux, she has had since she was almost 18 years old. The patient stated that they said she should get the vaccine because she has some medical stuff like issues with her stomach, bad migraines, panic attacks, anxiety, and acid reflux. There were no concomitant medications. There were no additional vaccines administered on same date of the suspect drug. On 07Apr2021, the patient got the Pfizer vaccine had symptoms like something caught in her throat and throwing up and diarrhea 1h after the vaccine. She panicked because she thought it was a severe allergic reaction. It's getting better and asking if its normal. She mentioned when discussing her panic attacks that she thought she was panicking when she got the vaccine but did not have a full panic attack. It was also reported that she got the Covid vaccine on 07Apr2021 at 1250, about an hour after she started throwing up. She said she has a lot of saliva and mucous coming up and stated it feels like she has a cold. She said she has a runny nose and is spitting up mucous and also she had some diarrhea. She wanted to know if these symptoms are normal. The patient stated that her mom drove her to and from her vaccine and when she got home, she laid down and continues to do so. Symptoms began an hour after vaccine given on that day, difficulty verifying outcomes. Stated she has stopped vomiting for now. She did not say she has recovered from any mentioned symptoms. There were no relevant tests done. The outcome of the event of severe allergic reaction was recovering and other events was unknown.
30 2021-04-25 swelling of eyelid Swollen eye lid on left eye.
30 2021-04-26 loss of smell I received the 2nd dose of the vaccine at 5pm on 4/26 and around 10:30pm on 4/26 I lost my sense of ... Read more
I received the 2nd dose of the vaccine at 5pm on 4/26 and around 10:30pm on 4/26 I lost my sense of smell
30 2021-04-26 mouth swelling, mouth pain, ear discomfort, ear infection, ear pain 1) Body aches start around 10pm day of injection (4/21) 2) Woke up with body aches, headache, and fa... Read more
1) Body aches start around 10pm day of injection (4/21) 2) Woke up with body aches, headache, and fatigue the next day (4/22) 3) Developed low fever of 100.1 (ear thermometer) in afternoon and lasted through rest of day. Also became nauseous in afternoon and vomited. Developed sores in mouth/mouth felt swollen. (4/22) 5) Woke up next day without fever but still had everything else. Vomited after lunch. Left ear clogged and painful (4/23) 6) Clogged ear and pain (likely ear infection?) has lasted until at least today. Mouth less painful today. (4/27)
30 2021-04-26 swelling of eyelid Very heavy painful period Swollen and painful red eyelid for 2 days
30 2021-04-26 vision blurred Patient reported symptoms of tachycardia and dizziness around 10 minutes after receiving the dose. S... Read more
Patient reported symptoms of tachycardia and dizziness around 10 minutes after receiving the dose. She also reported blurry vision. An ambulance was called to the scene and EMS took her blood pressure, pulse, and blood sugar. All came back within normal limits. Patient was given water and EMS offered to take her to the hospital. Patient refused to be taken to the hospital. She was advised to stay for at least another 15 minutes. When she left the pharmacy she said she was feeling better. I called her at 2:30 pm to check on her and she stated she was feeling fine and "back to normal". I advised her to call the pharmacy if she has any questions and to seek medical help if symptoms come back.
30 2021-04-27 tunnel vision lost consciousness for a brief period; doing something that looked like a small seizure; got tunnel ... Read more
lost consciousness for a brief period; doing something that looked like a small seizure; got tunnel vision; vasovagal response; feel faint, dizzy, and lightheaded; feel very weak; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Apr2021 at 14:30 at single dose in left arm for COVID-19 immunisation at the age of 30-year-old. Lot number was EP7524. Medical history included periodontal surgery. Concomitant medications included spironolactone, adapalene, benzoyl peroxide (Epiduo Forte), azelaic acid (FINACEA), aciclovir, hydrocortisone (Xerese). The patient believed she experienced some kind of vasovagal response. On 13Apr2021 at 08:00, the patient got up from sleeping and went to the restroom, where she started to feel faint, dizzy, and lightheaded. The patient sat down and got tunnel vision and she started to feel very weak but regained her vision after sitting. The patient was helped back to bedroom but had to stop and sit in the floor where patient lost consciousness for a brief period, less than 10 seconds. Her partner said patient was doing something that looked like a small seizure. The patient had had this response before many times when giving blood and even after her periodontal surgery. The patient was recovering from the events.
30 2021-04-28 visual impairment 15 min after vaccine patient stated she felt lightheaded and had spotty vision. She complained of ch... Read more
15 min after vaccine patient stated she felt lightheaded and had spotty vision. She complained of chest tightness. We laid her on a cot and gave her water. After 10 mins she stated the chest tightness and vision changes were resolved. She now states she has a headache. She got ibuprofen out of her purse and took some. She stood up and stated she was "much better."
30 2021-04-29 pupils dilated I got the shot at 4:45pm on Thursday and felt fine all evening. Around 6am Friday, I woke up feeling... Read more
I got the shot at 4:45pm on Thursday and felt fine all evening. Around 6am Friday, I woke up feeling nauseated. I got out of bed, walked to the kitchen and passed out on the kitchen floor. My husband said that I was unconscious with dilated pupils. I was unresponsive to him holding my shoulders and calling my name. When I regained consciousness, I continued to feel nauseous for another hour (couldn't walk or stand without feeling lightheaded). 2.5 hours later, I continue to have tingling in my arms, legs, and feet.
30 2021-04-29 tunnel vision pt feeling anxious and nervous prior to coming for her vaccine c/o lightheadedness, tunnel vision im... Read more
pt feeling anxious and nervous prior to coming for her vaccine c/o lightheadedness, tunnel vision immediately after vaccination. pt was place in trendelenburg with significant improvements. pt sat up with no symptoms. started eating graham crackers and water. pt dispo home with husband and child and walked outside with no distress. vitals: T-burg 1749 118/79; rr 18; 77; 118/79; 98% sitting 1753 125/81; rr 18; 71; 100% standing 1803 134/92; 72; 100%
30 2021-04-29 vision blurred Blurred vision in right eye with some distortion; came very suddenly
30 2021-05-01 taste impairment 24 hour fever and chills Headache Loss of appetite Body aches Metallic taste in mouth
30 2021-05-01 taste impairment Metallic taste that started 5 minutes following vaccine and is still present 25 hours later. *Pregna... Read more
Metallic taste that started 5 minutes following vaccine and is still present 25 hours later. *Pregnant- due 5/23/21
30 2021-05-02 swollen lips, lip swelling Approximately 48 hours after receiving my second COVID-19 Pfizer dose, I woke up with a very slightl... Read more
Approximately 48 hours after receiving my second COVID-19 Pfizer dose, I woke up with a very slightly swollen upper lip, and it was itchy and very dry. At first I thought it might have been a bug bite, but then I noticed I?d developed some small bumps on my lip. This morning, 72 hours post-shot, it had gotten a bit worse, and there were a few more bumps visible. There have been no signs of anaphylaxis and I feel fine other than slight discomfort and occasional itchiness. I did not consume anything abnormal, nor did I use something on my face or mouth that I normally don?t. Therefore I assume this is a slightly delayed reaction to the vaccine itself. It is localized to my upper lip only.
30 2021-05-02 eye pain, ear discomfort I took my first Pfizer shot on 4/25/2021 and I started feeling "woozy" about 3 hours after the shot.... Read more
I took my first Pfizer shot on 4/25/2021 and I started feeling "woozy" about 3 hours after the shot. I got a headache that night, but it went away. On Monday (the following day), I woke up with my ears popping and pressure in my head, still feeling woozy/dizzy. On Tuesday, my whole body was exhausted, and I took the day off from work. I was not drowsy, just physically exhausted. I went to urgent care and took a COVID test just in case. It was negative. The exhaustion was better on Wednesday and I returned to work (I work at a bank), still feeling woozy/dizzy. I first described this woozy/dizzy feeling kind of like changing eye glasses prescriptions or like being on a boat or right when you get off a spinning ride like the teacups , except pretty constant and does not go away. Thursday I noticed if I touched under my left eye, it hurt, and when I blinked it hurt (still dizzy). That got better on Friday. I continued feeling woozy/dizzy the whole weekend with some pressure in the head. I noticed on Sunday that if I pressed the bone right above and behind the left earlobe, it hurt, so I made an appointment with an ENT doctor. I went to work today, but immediately felt dizzy when looking at my computer screen and down to my papers so I went to urgent care again. I have taken Tylenol which helped with the headache the first day. I have been trying to take an Advil every 4 hours for the past day or so to see if I possibly have some inflammation somewhere. I have also started to take EmergenC and Benadryl.
30 2021-05-02 oropharyngeal discomfort, lacrimation increased "fullness" in throat, watery eyes
30 2021-05-02 swollen tongue, lip swelling Swollen lips, tongue and throat
30 2021-05-03 blindness Loss of peripheral vision in left eye
30 2021-05-05 bloodshot eyes, tongue itchiness, eye itchiness 12:15 PM ? Received Covid vaccine #1 and was to stay in observation x 30 mins. 12:25 PM (approximate... Read more
12:15 PM ? Received Covid vaccine #1 and was to stay in observation x 30 mins. 12:25 PM (approximated time) ? Pt. reports hot face, scratchy eyes, anxiety per RN who was at patient?s side. Pt. in seated position. Vitals: B/P 130/70, HR 100 12:27 PM ? Vitals: 124/80, 100% O2sat, HR 97, R 20. Pt. appears anxious, mild bilateral eye redness, tongue pruritis, ?face still feels warm?, sinus congestion developed, lungs auscultated and clear all fields, no respiratory distress, can speak in full sentences, A&O. EMS called. Epipen at patient?s side, not given at this time. RN's and Pharmacist by patient?s side. 12:34 PM ? Epipen advised and pt. agrees to administration. Epipen administered R upper thigh ? tolerated well (Mylan Lot #0FM407, Exp. 2/2022) by Pharmacist. 12:35 PM ? HR 88, 99% O2sat 12:37 PM ? Pt. reports, ?I feel like I?m going to pass out?, ?feeling faint and jittery.? Pt. appears weak, pale without respiratory distress. RN stabilized pt. and pt. was transferred safely to the ground. Pt. remains A&O but weak. Vitals: 130/70, HR 115, R 20, 100% O2sat. 12:44 PM ? EMS arrived 12:45 PM ? EMS reported vitals: 180/110 12:50 PM ? Pt. continues to present with weakness. Pt. assisted to gurney with EMS support. Pt. had one episode of emesis while on gurney, airway clear. Patient?s partner arrived per pt.?s request. 12:55 ? EMS departs to transport patient. Patient alert, eyes tracking.
30 2021-05-07 taste impairment delirious; left side of body feeling swollen; whole body sensitive; do not want to eat anything; hav... Read more
delirious; left side of body feeling swollen; whole body sensitive; do not want to eat anything; have a metallic taste in my mouth; nausea/I still feel nausea; I woke up at 4am on Thursday feeling chills; This is a spontaneous report from a contactable consumer. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Left Arm on 21Apr2021 13:30 (Batch/Lot Number: ER8729) as SINGLE DOSE (at the age of 30) for covid-19 immunisation. Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was given on 30Mar2021 16:45 lot number EW0150, in left arm for Covid-19 immunisation. Medical history was none. The patient did not have Covid-19 prior vaccination. The patient had no known allergies. The patient is not pregnant. Concomitant medication included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for an unspecified indication. The patient took no other vaccine except BNT162B2 in four weeks. The patient experienced delirious (medically significant) on 22Apr2021 04:00 with outcome of recovering, left side of body feeling swollen on 22Apr2021 04:00 with outcome of recovering, whole body sensitive on 22Apr2021 04:00 with outcome of recovering, do not want to eat anything on 22Apr2021 04:00 with outcome of recovering, have a metallic taste in my mouth on 22Apr2021 04:00 with outcome of recovering, nausea and still feel nausea on 22Apr2021 04:00 with outcome of recovering, woke up at 4am feeling chills on 22Apr2021 04:00 with outcome of recovering. The patient was not Covid tested post vaccination.
30 2021-05-08 dry throat, taste impairment Bad/Metallic Taste in mouth Jittery Dry Nose/Throat
30 2021-05-09 lip swelling Lip and Face swelling Severe rash on abdomen and severe itching (small pimples) like rash
30 2021-05-10 mouth swelling Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth s... Read more
Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); This is the spontaneous report received from a contactable other health professional. This other HCP (patient) reported for herself that a 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) at the age of 30-years, via an unspecified route of administration in left arm on 19Mar2021 13:00 at single dose for COVID-19 immunization, in hospital. Medical history included PTSD, anorexia, chronic migraines, bradycardia. Patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included propranolol, atorvastatin (LIPITOR), prazosin, alprazolam (XANAX). On 19Mar2021 13:15, the patient experienced allergic reaction-characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling). After medical treatment, hives continued for 3-4 days. The events result in doctor or other healthcare professional office/clinic visit. The patient received high dose diphenhydramine hydrochloride (BENADRYL) and epinephrine (EPIPEN). Outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Allergic reaction, Anaphylactic reaction. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
30 2021-05-12 taste impairment A couple of weeks after getting my second COVID vaccine dose, I became unable to eat meats. Meats be... Read more
A couple of weeks after getting my second COVID vaccine dose, I became unable to eat meats. Meats began tasting like chemicals and like rotten meat, and they smell that way too. Meat and some other foods, that I was previously able to consume, now make me vomit. This is the only thing I can link to this issue due to it not being that way before I received the COVID shot.
30 2021-05-12 hearing loss, visual impairment hard to hear at times; horrible pain from head to toe; couldn't see anything; couldn't breathe at al... Read more
hard to hear at times; horrible pain from head to toe; couldn't see anything; couldn't breathe at all; face turned green; fever; aching in her legs; extreme exhaustion; blacking out; diarrhea; sweating; unable to talk; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 12:00 (Batch/Lot Number: EW0150) as 1st dose, single, at the age of 30-years-old for COVID-19 immunization. The patient had no medical/family history and concomitant medications. The patient went to go get her second shot of Pfizer covid vaccine but they wouldn't give it to her based on her reactions to the first dose. They said there was a chance of anaphylaxis reaction to the second shot. The patient reported blacking out, diarrhea, sweating and unable to talk. She consulted with her healthcare professional regarding whether to get the second shot and they didn't know. She asked if her reactions were normal. She doesn't know what to do whether to get a second shot given her reaction. It was mentioned that the patient was hard to hear at times. She got the vaccine on 06Apr2021 around noon and she was fine until around 3:30 am. She woke up in horrible pain from head to toe, she thought maybe she just needed to pee, she didn't know what was going on. She stood up and she blacked out like she was about to faint. She couldn't see anything, like it was completely black. She got to bathroom and she couldn't breathe at all, she couldn't talk. She thought she needs to go to the hospital, but she couldn't talk. Her face turned green, she had diarrhea, she was like dripping wet. At this point, she could sort of breathe. She felt like she was being held under water, still dripping sweat. She has recovered completely from these symptoms. The severity of symptoms was so severe she doesn't know if she had a fever at the same time, it was hard to tell. With the breathing part, she was so freaked out by that, so it's hard to know for sure, maybe yes. She may have had a low fever. She had a fever that night to the point where she was dripping on the floor. She has aching in her legs. She went to the doctor thinking she had Lyme disease, which she doesn't. Since that vaccine, she's had very, somewhat severe leg aches and extreme exhaustion like all the time. she can hardly go to work sometimes. Everybody has days they are tired, but this was different. She had to come home at 2pm and lay down for like five hours. She stated it was persisting. She had a blood test recently and everything came back perfect on 26Apr2021. She thought she had Lyme disease because of all the symptoms she was having, and it all came back negative. She didn't exactly get turned away. They said they didn't feel comfortable giving her the second dose of vaccine. The patient stated if a nurse tells her they don't feel comfortable, she wouldn't feel comfortable until she speaks to Pfizer. The nurse told her she had to go to an allergist and rheumatologist. The nurse said the same thing, the nurse told her that she should have gone to the hospital, but she wasn't thinking at that moment. She was just at a loss of what to do. That day at the hospital, they were scared with the second vaccine that she could go into anaphylaxis and she's not sure what to do. The patient had no other vaccines administered on the same date of Pfizer suspect and no other vaccinations within 4 weeks. The event hard to hear at times started on an unknown date while other events started on 07Apr2021 and ended the same day. The outcome of the events aching in her legs and exhaustion was not recovered, hard to hear at times was unknown while for other events was recovered. The events "she blacked out, like she was about to faint" was assessed as serious medically significant. No follow-up attempts are needed. No further information expected.
30 2021-05-12 smell distorsion, taste disorder Two days after I received the COVID vaccine I had a distortion in my smell and taste. It was not gon... Read more
Two days after I received the COVID vaccine I had a distortion in my smell and taste. It was not gone; everything just smells and tastes bad. The best way I can describe it is that it smells like infection. It has been three weeks since the vaccine and these symptoms still have not gone away. I need help in trying to figure out how to fix this.
30 2021-05-12 ringing in ears, ear discomfort within 12 hours of receiving my vaccine I had the usual symptoms (chills, aches, fever, nausea) I t... Read more
within 12 hours of receiving my vaccine I had the usual symptoms (chills, aches, fever, nausea) I took Tylenol for the fever. However after that first 24 hours, the adverse reaction began. I had constant dizziness, veritgo type symptoms and extreme fatigue. I have now suffered with the vertigo and dizziness non-stop for the past 6 and a half weeks. I went to three primary care doctors in my family practice, I saw 2 ENT's, my endichrinologist and my recenetly a neurologist. I had a complete blood work up and various exams as well as a visit to the Urgent care and all of the medical professionals I have seen had said that this is an inflammatory reaction to the vaccine. I was even prescribed a 5 day prednisone course which did not relieve the dizziness. I have tried antihistamines, vitamin c, ibuprofen, and nothing can take away the symptoms. I have also had ear fullness and pressure in my head with occasional tinnitus, and very foggy brained. I have not been able to drive or care for my 2 year old or work during this time.
30 2021-05-12 ringing in ears Onset of bilateral constant tinnitus within 24 hours of 2nd shot. Hearing normal, no risk factor/ex... Read more
Onset of bilateral constant tinnitus within 24 hours of 2nd shot. Hearing normal, no risk factor/exposures
30 2021-05-13 sensitivity to light, vision blurred I felt no pain after shot. Went to sleep around 8pm woke up at 10pm to find my vision was blurry. ... Read more
I felt no pain after shot. Went to sleep around 8pm woke up at 10pm to find my vision was blurry. I went back to bed and woke up 7am with sore left arm, body ache, head ache and blurry vision. It?s hard for my eyes to focus on things, light hurts my eyes and it?s blurry
30 2021-05-13 tunnel vision 102 degree fever, worst headache ever experienced, chills, nausea, inability to eat, fatigue. all oc... Read more
102 degree fever, worst headache ever experienced, chills, nausea, inability to eat, fatigue. all occuring simultaneously from may 10 at 10pm to may 13 at 3pm at 3pm on may 13 symptoms shifted to extreme dizziness, nausea, and inability to sit, stand or raise arms in lying position without feeling overwhelming sensation of being about to faint or black out. vision tunnels from standing longer than one minute. this is ongoing as of writing this may 14th.
30 2021-05-14 sensitivity to light 5 days of heart palpitations; racing heart; extreme light sensitivity; dizziness; fever; chills; Thi... Read more
5 days of heart palpitations; racing heart; extreme light sensitivity; dizziness; fever; chills; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 30Dec2020 18:45 (Lot Number: EK9231) at age of 30 years as single dose for covid-19 immunisation. Medical history was not reported. Patient was not pregnant. Concomitant medications were reported as none. Patient reported 5 days of heart palpitations, racing heart, dizziness, fever, chills and extreme light sensitivity. These symptoms kept happening since vaccine off and on. The latest landed patient in the hospital for 5 days. Patient had been released but was bedridden with all euro symptoms listed above. Treatment received scans etc, IV fluid and medications to relieve sym. Since the vaccination, the patient had not been tested for COVID-19. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
30 2021-05-14 visual impairment, vision blurred, hearing loss I got vaccinated last Friday afternoon, was sore Saturday morning, and got intense chills Saturday a... Read more
I got vaccinated last Friday afternoon, was sore Saturday morning, and got intense chills Saturday afternoon and went to bed (wore two layers of clothing and had three blankets plus my heater going). On Sunday the 9th, early morning (4:20am), I went to the restroom and passed out/fell after washing my hands. It happened again trying to get to my room, and a third time trying to turn on my light when my roommate called out wondering what all the noise was. My speech was slurred, my vision black and fuzzy, and I could barely hear her voice. I also was sweating a lot. It took about five minutes for me to become coherent enough to call the 24 hour nurse line. Though I was coherent, I couldn't stand without feeling dizzy, and was advised to call 911. Paramedics ran tests to see if my blood sugar/anything stroke related could be the cause, and the doctor/nurses at the ER ran blood tests as well. Everything came back normal, and they concluded my passing out was likely due to the vaccine. I was discharged around noon, and since then have not fallen or felt the same level of dizziness.
30 2021-05-14 visual impairment Severe unknown neurological illness, including the following symptoms: dizziness/vertigo, intense vi... Read more
Severe unknown neurological illness, including the following symptoms: dizziness/vertigo, intense visual disturbances, nerve pain within the legs, trouble walking off and on, muscle/bone aching within legs, fatigue and tremors.
30 2021-05-15 extreme sound sensitivity Hyperacusis for 24h on left, then left hearing change for 1 week
30 2021-05-18 ear infection, ear discomfort, ringing in ears None stated.
30 2021-05-19 deafness, vision blurred Pt experienced intense chills and arm soreness on Saturday afternoon, the day after the vaccine. Pt... Read more
Pt experienced intense chills and arm soreness on Saturday afternoon, the day after the vaccine. Pt fell and fainted for a few seconds while going to the bathroom. Pt experienced slurred speech, fuzzy vision, and hearing loss for about 5 minutes after regaining consciousness. Ambulance took pt to .
30 2021-05-19 visual impairment, vision blurred Unusual vision (blurry, hard to read words, bands of dots) headache around right eye, severe nausea,... Read more
Unusual vision (blurry, hard to read words, bands of dots) headache around right eye, severe nausea, heavy prickling forearms.
30 2021-05-20 hearing loss, ear pain Sharp pain reported in right ear with mild hearing impairment. Reported to feel similar to pain caus... Read more
Sharp pain reported in right ear with mild hearing impairment. Reported to feel similar to pain caused by pressure changes during taking off in an airplane.
30 2021-05-20 vision blurred Approximately 24-30 hours after vaccination I experienced blurred vision. It began with what looked ... Read more
Approximately 24-30 hours after vaccination I experienced blurred vision. It began with what looked like someone had just taken a picture with a flash and progressed to blurred vision to the point of not being able to clearly read text messages on my phone. I have never had an ocular migraine, migraine or experienced migraine aura before but after researching them I suppose that is what it most closely resembled. It lasted about 30 minutes. The following day I experienced a headache that lasted until I took something OTC.
30 2021-05-21 eye movement disorder Patient had 3 seizures at home hours at receiving the second vaccine shot. First one occurred while ... Read more
Patient had 3 seizures at home hours at receiving the second vaccine shot. First one occurred while sitting on the couch. She fell on the floor and started convulsing/shaking. That lasted about 15 seconds. This occurred at approx. 5:30 p.m. 30 minutes later, patient had another seizure while heading to the kitchen. She stated she couldn't see and fell. She then started shaking and her eyes rolled back. The last one occurred while she was in bed trying to relax after the previous 2 seizures had occurred. Same effect occurred.
30 2021-05-21 lip swelling, mouth tingling lip swelling, tongue tingling
30 2021-05-23 eye twitching Myokymia in right lower eyelid (Constant twitches in lower eyelid) May 18- current
30 2021-05-23 lip swelling, swollen tongue Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to allergy clinic for follow-up four months a... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to allergy clinic for follow-up four months after immunization. Within five minutes of immunization patient reports diarrhea and throat itching. Within ten minutes reports injection site feeling hot, hives, rash, and itching all over body then developed tongue and lip swelling, coughing, and post nasal drip. Patient went to the emergency department, given epinephrine, famotidine, methylprednisolone, and diphenhydramine, monitored for a few hours, and discharged to home. Patient has not experienced any similar symptoms since immunization.
30 2021-05-23 ringing in ears I have no tinnitus history, but 9 days after the first Pfizer vaccine, I started to have a low-pitch... Read more
I have no tinnitus history, but 9 days after the first Pfizer vaccine, I started to have a low-pitched ear ringing. It has been 5 weeks since then and it is still not gone away.
30 2021-05-24 loss of smell Loss sense of smell 3/27/2021 tested due to known exposure /3/24/2021 tested positive for covid-19, ... Read more
Loss sense of smell 3/27/2021 tested due to known exposure /3/24/2021 tested positive for covid-19, 3/29/2021 and 3/30/2021
30 2021-05-25 ear pain, ringing in ears Tinnitus, dizziness, ear pain, potentially eustachian tube dysfunction
30 2021-05-25 vision blurred About 20 hrs after second dose, I experienced low grade fever (100.4 degree f).; chills; fogginess; ... Read more
About 20 hrs after second dose, I experienced low grade fever (100.4 degree f).; chills; fogginess; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: En6201) on 16Feb2021 at 16:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. The patient didn't have medical history. Concomitant drug included metformin and melatonin. The patient received first dose of BNT162B2 on 22Jan2021 at 04:00 pm on left arm. On 17Feb2021 at 13:00 about 20 hours after second dose, patient experienced low grade fever (100.4 degree f). The patient recovered from the events on an unspecified date. No follow-up attempts are possible. No further information is expected.
30 2021-05-26 smell distorsion Fevers; Chills; Felt like I was going to faint; Arm was hurting; Felt super bad; Felt super hot then... Read more
Fevers; Chills; Felt like I was going to faint; Arm was hurting; Felt super bad; Felt super hot then very cold; Felt like I had to vomit but I didn't; Pale; When I tried to move my arm I couldn't move it at all it was like it completely fell asleep; Fingers twisted; Smelled alcohol; Back hurt; Head hurt/light headaches; This is a spontaneous report from a contactable consumer(patient) reported for herself. A 30-years-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 06May2021 (Batch/Lot Number: EW0172) at 0.3 ml single for COVID-19 immunization. The patient had no known allergies and other medical history. The patient did not have COVID-19 prior vaccination. The patient was not pregnant. No other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose bnt162b2 (BNT162B2), administered in Arm Left on 15Apr2021 04:00 pm (Lot Number: EW0153) for COVID-19 immunization. The next day after she got the vaccine, when she woke up her arm was hurting and then out of nowhere she felt super bad that she had to sit on the floor because she felt like she was going to faint. Then she felt superhot then very cold and she felt like she had to vomit but she didn't, her mom said she was pale and then when she tried to move her arm she couldn't move it at all it was like it completely fell asleep and her fingers twisted. she smelled alcohol and she started feeling better, all this happened in a matter of 10-15 mins. Then she spent the whole day in bed with fevers and chills every once in a while. The next couple of days her back hurt and her head hurt. she still get light headaches and her back hurts sometimes. Event onset date was 07May2021 09:00. The patient did not receive treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient come of the events was recovering
30 2021-05-26 ringing in ears, ear itchiness, hearing loss, ear pain, ear discomfort My ears began to pop, hurt, and itch then started ringing; My ears began to pop, hurt, and itch then... Read more
My ears began to pop, hurt, and itch then started ringing; My ears began to pop, hurt, and itch then started ringing; My ears began to pop, hurt, and itch then started ringing; My ears began to pop, hurt, and itch then started ringing; ringing will decrease, increase and will even become muffled; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), dose 2 via an unspecified route of administration in left arm on 28Mar2021 09:00 (at the age of 30-years-old ) as second dose, single for COVID-19 immunization. Medical history included known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) via an unspecified route of administration in left arm on 07Mar2021 08:45 as first dose, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. The patient received some other medications within two weeks prior to vaccination. On 05Apr2021, the patient's ears began to pop, hurt, and itch then started ringing intermittently within a week of taking the second COVID-19 dose. Shortly thereafter, they began to ring continuously and hadn't stopped. Sometimes the ringing will decrease, increase and will even become muffled and things will sound like she was under water. She had been seen at urgent care twice for this issue and now scheduled to see an ENT on 20May2021 at 3:15PM. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date, post vaccination. Events were treated with two rounds of antibiotics. Outcome of the events were not resolved. Information on the lot/batch number has been requested.
30 2021-05-28 ringing in ears severe brain fog; I was very drunk,slurring my words or had been hitting the bottle; My memory of th... Read more
severe brain fog; I was very drunk,slurring my words or had been hitting the bottle; My memory of the previous day was mostly temporarily lost; I developed Pulsatile tinnitus hearing wooshing loudly in my head from blood; This is a spontaneous report from a contactable consumer (patient). This 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left, on 22Feb2021 15:45 (at the age of 30-year-old) (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included lupus and allergy to sulfa. Concomitant medications included hydroxychloroquine taken for an unspecified indication, start and stop date were not reported; iron taken for an unspecified indication, start and stop date were not reported; biotin taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 16:45 (Lot number EL3249). On 24Feb2021 21:30, the patient experienced "severe brain fog within the first 60 hours beginning the morning after the 2nd shot starting around hour 15". People around her commented it sounded like she was very drunk slurring her words or had been hitting the bottle. Her memory of the previous day was mostly temporarily lost. The patient also experienced "pulsatile tinnitus hearing wooshing loudly in her head from blood" on 24Feb2021 21:30. The events resulted in doctor or other healthcare professional office or clinic visit. It was unknown if the patient received corrective treatments. The patient had not had COVID prior to vaccination and she was not tested for COVID post vaccination. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
30 2021-05-30 vision blurred Client stated, "My vision became blurred and I felt spinning." Client given water and crackers. Sym... Read more
Client stated, "My vision became blurred and I felt spinning." Client given water and crackers. Symptoms lasted less than 2 minutes and then went away completely. Had TDAP 5/26/21 without any reactions.
30 2021-05-31 eye twitching Eyelid twitch returned after the vaccine; Chills; headache; body aches; minor nausea; tiredness; wea... Read more
Eyelid twitch returned after the vaccine; Chills; headache; body aches; minor nausea; tiredness; weakness; This is a spontaneous report from a contactable other health professional(patient). A 30-year-old female patient received BNT162B2 (COMIRNATY, Solution for Injection, lot number: EN9581, Expiration date: unknown), via intramuscular route of administration on left arm on 01Feb2021 at 09:30 AM as unknown, single for covid-19 immunization. The patient medical history included a history of an eyelid twitch. The patient's concomitant medications included vitamin D3, zinc picolinate, vitamin C, vitamin A. On 01Feb2021 at 07:30 PM the patient experienced chills, headache, body aches, minor nausea, tiredness, and weakness were severe for about 24 hours. These symptoms were managed with extra strength Tylenol every 4 hours and sleep. The symptoms were lessened but remained for another 12 hours. A minor headache was still present 78 hours later. The twitch returned after the vaccine. The outcome of the event eyelid twitch returned after vaccine was unknown. Outcome of other events was recovering. Follow-up attempts are completed. No further information is expected.
30 2021-06-01 ringing in ears Two days after shot 1, I experienced very loud, high pitched, bilateral tinnitus. It has significant... Read more
Two days after shot 1, I experienced very loud, high pitched, bilateral tinnitus. It has significantly decreased my quality of life and I'm now struggling with anxiety and depression due to it. I have never had tinnitus before and am otherwise perfectly healthy - no structural issues to the ear, no hearing loss, etc. The vaccine caused it. I will not be getting a second shot, especially as there is still limited information available.
30 2021-06-01 vision blurred Pt experienced weakness in body and blurry vision 5 minutes after 2nd dose of COVID-19 Pfizer. Pt wo... Read more
Pt experienced weakness in body and blurry vision 5 minutes after 2nd dose of COVID-19 Pfizer. Pt woke up the next day to sharp lower back pain, body aches, HA and stomach discomfort.
30 2021-06-03 dry eye, loss of taste Bells Palsy (loss of taste, dry eye, acute facial paralysis on right side of face)
30 2021-06-05 mouth numbness, mouth itchiness Patient came back to the front of the pharmacy with symptoms of itchiness and numbness around the m... Read more
Patient came back to the front of the pharmacy with symptoms of itchiness and numbness around the mouth area after 30 minutes of receiving her vaccination. Patient was observed for about another 45 minutes after receiving 2 tablets of Benadryl and symptoms subsided. Patient was able to go back home with her spouse after confirming her improvement.
30 2021-06-07 smell distorsion Pt had COVID infection with loss of taste and smell 1/2021. Completed last dose of Pfzier COVID vacc... Read more
Pt had COVID infection with loss of taste and smell 1/2021. Completed last dose of Pfzier COVID vaccine 2/12/21. One month later noted distorted odor with foods, continues to have parosmia now without improvement
30 2021-06-09 ringing in ears Chills, heavy breathing, and sweating 2 and 3rd day post vaccine back pain started 05/25 pm for a... Read more
Chills, heavy breathing, and sweating 2 and 3rd day post vaccine back pain started 05/25 pm for about a week constant headache & migraine (started 05/26/2021 - 05/31/2021) neck pain started (05/29/21 - ended 06/04/2021) intermittent ringing in ears (5 days after- 5/29/2021- 6/2/2021)
30 2021-06-10 mouth numbness Constant pain in arm. Over 10 days, pain radiated outward from injection site. Pain spanned chest, a... Read more
Constant pain in arm. Over 10 days, pain radiated outward from injection site. Pain spanned chest, and entered chest cavity. I experienced shortness of breath for about 3 days while walking normally and going up and down stairs. Pain dissipated by the end of day 10. During these 10 days, pain radiated up my neck and at one point the right side of my cheek and upper lip went numb for about 2 minutes. Then starting on around June 6th, pain in abdomen started. Symptoms of current experience includes: nausea, diarrhea, abdominal pain in lower right, upper left, and back on left side. Pain is mild to moderate, comes and goes. Feeling of fullness and pressure in abdomen constantly, even before eating for the first time of the day. Very fatigued. Menstrual cycle is late. Pregnancy test is negative. Dr. performed a battery of tests - urinalysis, blood, and COVID-19 nasal swab. CT scan of abdomen scheduled for Monday June 14 with Oral Contrast. IV Contrast allergy.
30 2021-06-13 lip swelling, mouth tingling 4:15- Pfizer coivd-19 vaccine placement to left Deltoid 4:40 Pt reported Right sided neck stiffness ... Read more
4:15- Pfizer coivd-19 vaccine placement to left Deltoid 4:40 Pt reported Right sided neck stiffness and tightness, HR 65, RR 32, BP WNL 4:45 Report right lower lip tingling, noted slight swelling to right lower lip. Airway clear. HR 77, 99% on RA, RR26, BP WNL. 5:00 25mg Benadryl IM given to right deltoid 5:05 reports lip tingling reducing, reports neck stiffness reducing. PT alert and oriented. 5:10 Vitals signs within normal limits. 5:15 Amb to BR with steady gait A&O. States symptoms improving. Swelling to Right lower lip reduced. Pt escorted home by friend and stayed with husband.
30 2021-06-14 ear pain, ringing in ears after vaccination had pulsating heartbeat in left ear, same side as administered shoulder. 5 weeks l... Read more
after vaccination had pulsating heartbeat in left ear, same side as administered shoulder. 5 weeks later took Excedrin migraine as recommended by doctor and went away. two days later had pain on left side of face, ear, throat and neck. now have severe neck pain, throat on left side and ear pain in that ear. put on steriod methylprednisolone to see if it helps.
30 2021-06-16 permanent deafness sudden onset sensorineural hearing loss and labrynthitis left ear onset tuesday 6/1/21 complete hea... Read more
sudden onset sensorineural hearing loss and labrynthitis left ear onset tuesday 6/1/21 complete hearing loss occurring over 6 hour period followed by vertigo with vomiting. loss of balance and coordination, nystagmus. undergoing series of 3x intratympanic steroid injections, 1 week apart.
30 2021-06-17 tunnel vision, taste impairment, hearing loss ~5 minutes (near immediately) after receiving vaccination, I felt tingly in my extremities--mostly a... Read more
~5 minutes (near immediately) after receiving vaccination, I felt tingly in my extremities--mostly arms but a bit in the legs. While sitting in the waiting area, tingling continued, had brief sense of doom, waves of nausea, a metallic taste in my mouth, light-headedness, and the type of field-of-vision narrowing that occurs before one faints--but I did NOT faint. Companion stated my eyes were dilated and my skin slightly pale/green. Her voice and that of the pharmacist sounded far, muffled. Upon pharmacist recommendation, applied cool compress to forehead and slowly drank a soda for sugar+liquid. Within another 20-30 min, symptoms resolved.
30 2021-06-18 vision blurred Within the first 10 minutes of vaccination, I started to get blurry vision and feel faint. A sensati... Read more
Within the first 10 minutes of vaccination, I started to get blurry vision and feel faint. A sensation came over my entire body and I couldn?t feel or control my body. I experienced tetany and lost control of my muscles in my arms, hands, and legs. A positive Trousseau sign was visible in both of my hands. All of these symptoms lasted about 15-20 minutes.
30 2021-06-19 ear infection, pain in jaw Forgot to mention this in previous submission. Facial swelling, primarily on right side of face. P... Read more
Forgot to mention this in previous submission. Facial swelling, primarily on right side of face. Pain in lower right jaw with itching and itching in throat. Rapid heart rate.. It took 4 days for swelling to dissipate. Developed ear infection with rapid heart rate.
30 2021-06-19 mouth numbness On June 16 when I got the shot, about an hour later I started getting a headache that started in the... Read more
On June 16 when I got the shot, about an hour later I started getting a headache that started in the back of my head. When I woke up on June 17 at 7:45AM I had a slamming headache that again started from the back of my head and radiated both upward and downward into my neck and shoulders. The headache was there all day and all of the following day, June 18. Then on June 19 I woke up at 7:45AM with the headache significantly decreased. In place of the headache I had numbness on the left side of my face. I was unable to move the left side of my face at all. The left side of my tongue was numb. The numbness and tingling goes to my left ear and the left side of my neck. On June 20 I had all the same symptoms with the left side of my face. I called my PCP who told me it sounded like Bell's Palsy and that I needed to go to the hospital. At the hospital they ruled out any neurological issues. I was diagnosed with Bell's Palsy (which I have NEVER had before). They ordered Prednisone which I will start taking tomorrow since my pharmacy was already closed. They also took bloodwork testing for lyme disease which there are no results for yet. As for pregnancy, there is no history to share beside me being 23 weeks pregnant and I am due October 15.
30 2021-06-19 pain in jaw Facial swelling on Saturday evening with itching on face and inside throat. Slight pain on right jaw
30 2021-06-19 swollen tongue, lip swelling Allergic reaction: swollen lips and tip of tongue. *Swollen veins in arms, hands, chest, and feet p... Read more
Allergic reaction: swollen lips and tip of tongue. *Swollen veins in arms, hands, chest, and feet progressively getting worse as of 9 days after vaccination
30 2021-06-20 visual impairment, vision blurred, eye pain After getting the shot the day of i felt ok but I had gone to bed the next day and woke up around 1:... Read more
After getting the shot the day of i felt ok but I had gone to bed the next day and woke up around 1:30am and i could not see at all. It felt like a liquid and something sharp was poured into my eyes I rubbed them but it didn't help i washed them out with water after running into everything getting to the sink. Spent a good half hour to hour freaking out rinsing and on text to talk with my mom asking what to do. After a while I was able to see a little bit of the kitchen light and I just decided to go to bed and hope its better in the morning. I woke up and my eyes hurt horribly but I am able to see a small amount with a ton of blurriness but I could see so I figure it will get better. I still am having a crazy hard time seeing everything is still really blurry. I have two toddler boys and an infant I am starting to stress out that its not coming back so I am making an appointment with my dr. My sister told me to report it to the cdc so I am.
30 2021-06-26 feeling of choking, mouth tingling 30 year old Female received her first dose of Pfizer Vaccine approximately @ 1211 (Lot #: ER8732 exp... Read more
30 year old Female received her first dose of Pfizer Vaccine approximately @ 1211 (Lot #: ER8732 exp 03/24/2021 @ 1045). Patient sat in EMT observation area for 25 minutes, then she reported having a tingling tongue and throat at 1236. EMT sat patient down in zero-gravity chair and started to assess patient, RN recorded incident and assisted with assessment. No sign of swelling in tongue and throat upon EMT assessment. Patient was given water and assessed her medical history, Patient stated that she has an allergy to peanuts and has Asthma, for which she carries an Epi-pen and inhaler on her person. First set of vitals at 1239 (RR 20, HR 96, O2 Sat 98%, unable to assess BP (Large cuff broke- used EMT?s BP Cuff for following BPs). At 1245, patient stated she continues to have tingling on her tongue and throat. Pt offered Benadryl and agreed. At 1250, RN administered 50mg PO Benadryl. Patient was educated of potential side effect of drowsiness with medication. Patient stated she would call her mom or roommate to pick her up. At 1255, vitals reported: (RR 14, HR 96, O2 Sat 97%, Left forearm BP 140/70). Patient stated blood pressure is in her normal range (Patient stated her previous reading was 137/79 last month). At 1257, patient stated she is feeling better and was singing along to the songs playing on the radio. At 1305, assessed vitals: (RR 16, HR 95, O2 Sat 97%, Left forearm BP 144/66). Patient stated she has no more tingling on her tongue or throat. At 1307, patient stood up and sat on a chair near the exit to wait for her roommate. At 1320, roommate picked up patient. Patient left site in stable condition and was alert and oriented x4 with a steady gait.
30 2021-06-28 sensitivity to light Day one- Started in research covid vaccine clinic?shortly after shot maybe 5-7 minutes - 1. At 4:50... Read more
Day one- Started in research covid vaccine clinic?shortly after shot maybe 5-7 minutes - 1. At 4:50pm felt dizzy, 2.started to tingly in left hand and made nurse aware 3. She checked if I could push her back. Lost motor function of whole left side and feeling 4. At 5pm Was rushed to ER there? They thought I was having a stroke or had one 5. Did Code stroke 6. Added an ivy during stroke and I couldn?t feel it and became light sensitive. 7. Shortly after CAT scan came back- no stroke 8. 5:30pm Moved to ER? was given large ivy dose of anti- histamine, anti nausea and I couldn?t move my whole left side and feel anything. My legs and arms felt dead. I would try but nothing happen. The drew several labs. 9. At 6:30pm did X-ray- everything was fine 10. At 7pm was admitted into hospital to stay overnight 11. At 8:00pm Did a movement test-no improvement and still had massive headache and sensitive to light Day 2 - Did eating test and eating was normal. I could finally feel my left side of lips and face- passed, PT- failed. Couldn?t walk. Feeling of legs slowly coming back. They did this test where I couldn?t push them away. Got an MRI- everything normal, they thought I was having a code- struggled at breathing, was out on oxygen, blood presume dropped, did blood cultures and X-ray, ekeg, They finally realized kept having these inflammatory responses where my blood pressure went from normal to drop then my body would get super red and hot to the touch. My injection site would swell and sometimes I struggled breathing so oxygen was provided. They put me on more antihistamines and Pepcid. MRI was clear, continued to have massive headache , In the evening I started to feel if you would pinch my arm or leg, but I couldn?t tell if you put hot or cold up against it. Day 3- The lab person came to grab blood and I could finally feel the ivy and blood. Also could get up move around finally. I finally could feel my legs and most of my arm. I still couldn?t tell if it was a light touch or hot/cold. Finally realized 4/11 at 7pm. Was told not to lift over 10 lbs and to follow up with primary Day 4- would get winded going up and down stairs, still struggled with hot and cold feeling on legs, would have inflammatory responses but could control them Day 5- met with primary care- nurse. She put on bendryll and Pepcid multiple times a day. I continued to have inflammatory responses Day 6- after talking to her medical group they decide to put me on steroids. By day 2-3 I was feeling normal still weak. Less inflammatory responses and injection site still very swollen Day 10- finally no more adverse symptoms
30 2021-07-03 ear discomfort, ear pain had pulsating in left ear. sore arm to todays date. ear pain (left ear). severe headache. dizzy. eve... Read more
had pulsating in left ear. sore arm to todays date. ear pain (left ear). severe headache. dizzy. every couple weeks things are getting worse. tingling in left arm/hand. left leg/foot
30 2021-07-07 drooping eyelid, eye strain Dizziness, "tired/droopy" eyes. Administered Benedryl waited 20 mins, Patient left for 15 minutes, ... Read more
Dizziness, "tired/droopy" eyes. Administered Benedryl waited 20 mins, Patient left for 15 minutes, came back with significant other and were advised to go to urgent care. Significant other drove patient to urgent care.
30 2021-07-10 vision blurred I received the second dose of the COVID-19 vaccine on January 13, 2021. In early March, I began expe... Read more
I received the second dose of the COVID-19 vaccine on January 13, 2021. In early March, I began experiencing some health concerns. I have a history of Dysautonomia and Anxiety. The dysautonomia has been controlled with lifestyle modifications for over 5 years. Symptoms experienced with it include low blood pressure, tachycardia, pre syncopal feelings and syncope. The occurrence of these symptoms became more frequent after receiving my second vaccination. In addition to above symptoms, my anxiety has worsened (which has been well controlled on the same medication for over 5 years), more syncopal episodes, acute weight loss, increased fatigue, lower baseline blood pressure, hair loss, temperature instability, and intermittent chest heaviness. In June, I had a dental procedure in which local epinephrine and lidocaine was used. I drove myself as I was told this would not be an issue since nitrous or general anesthesia was not used. I left the appointment to drive 20 minutes home. Within 5 minutes of my house, I began with pre-syncopal feelings (dizziness, blurred vision, pounding headache). I pulled off on side of road and within seconds, I had loss consciousness. I was by myself so unsure as to how long before I regained consciousness. When I woke up, I notified my spouse. I noted that I had loss bowel and bladder control during this episode, which has never occurred during my syncopal episodes. My foot was also cut from the foot pedals. My spouse said it took approximately 45 minutes for me to return to baseline. This episode was concerning for seizure activity, in which I will be evaluated by a Neurologist. I have no history of seizure activity. I have been evaluated per my primary and cardiologist. Cardiology believes my dysautonomia has worsened and is being exacerbated and feels as if this may have caused a rebound reaction to the local meds. But why now? Why is my dysautonomia worsening when I'm an otherwise healthy, young adult.
30 2021-07-12 pain in jaw Two weeks of severe jaw and neck pain, muscle pain and joint pain. Most severe in fingers and knees/... Read more
Two weeks of severe jaw and neck pain, muscle pain and joint pain. Most severe in fingers and knees/shins but also back and arms. Rash on elbows and ankles which is still coming back. Tired and unable to work before I needed so much sleep. Loss of appetite. Still suffering from swollen joints, pain and rash resurfaced.
30 2021-07-17 mouth itchiness Itchiness all over body/ inside of mouth was itchy too; Itchiness all over body/ inside of mouth was... Read more
Itchiness all over body/ inside of mouth was itchy too; Itchiness all over body/ inside of mouth was itchy too; This is a spontaneous report from a contactable consumer (patient). A 30-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 15Feb2021 at 11:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history includes Augmentin allergy. Concomitant medications were not reported. There was no other vaccine within four weeks of vaccination. The patient did not had Covid prior vaccination and not tested for Covid post vaccination. On 15Feb2021 at 17:30, the patient experienced itchiness all over body and inside of mouth was itchy too. The event subsided with Benadryl. The patient recovered from event in 2021. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
30 2021-07-17 ringing in ears Systemic: Tinnitus-Severe
30 2021-07-18 loss of smell, loss of taste, loss of taste, loss of smell VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being ... Read more
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/28/2021pfizer,Lot#EN5318 2nd dose: 02/18/21,Pfizer,Lot# EL9266 Diagnosed covid positive:07/15/21 Exposure:Community esposure Symptoms:cough, fatigue,muscle aches,loss of smell/taste, nasal congestion.
30 2021-07-18 hearing loss, blindness Less than 24 hours after receiving the second vaccine dose, I woke up in the middle of the night to ... Read more
Less than 24 hours after receiving the second vaccine dose, I woke up in the middle of the night to go to the bathroom. I was fine getting out of bed, walking to the bathroom, using the toilet, and getting to the sink. As soon as I turned on the faucet to wash my hands, I was hit with vertigo. The entire room started to spin. I lost my vision and tried to make my way back to the bedroom to wake my husband. Once I got in the bedroom I not only could not see but my hearing became muffled like I was under water. My husband was speaking to me but sounded like he was far away. After about 30 seconds, my vision came back as did my hearing. The vertigo spinning lasted about half that amount of time (15 seconds). I have never had vertigo before in my entire life.
30 2021-07-23 swelling of eyelid Approximately 4 days after my Pfizer vaccine my body broke out in severe hives(urticaria). The rash ... Read more
Approximately 4 days after my Pfizer vaccine my body broke out in severe hives(urticaria). The rash is focused on upper legs and abdomen with addition spots on hands, elbows, upper, arms, neck and back. The areas of my hands and wrist burn and are also stiff. My eye lids also became swollen .
30 2021-07-25 ear discomfort, hearing loss, ringing in ears, visual impairment I have experienced constant vertigo since taking the vaccine in April 2021. I feel as if I am consta... Read more
I have experienced constant vertigo since taking the vaccine in April 2021. I feel as if I am constantly on a boat. The symptoms have brought on a loss of balance and disequilibrium. I have had to seek vestibular therapy to help restore my balance, but I still feel disoriented when I move my head around a lot. My eyesight is fuzzy and I feel pressure and ringing inside my ears. My right ear feels clogged and the hearing is muffled. I also experience intense headaches on the sides of my head. I am a healthy 30 y.o. and have never had any of these symptoms before. A number of folks have had similar symptoms.
30 2021-07-26 ear discomfort I?ve been experiencing severe imbalanced and vertigo spells along with nausea stemming from the righ... Read more
I?ve been experiencing severe imbalanced and vertigo spells along with nausea stemming from the right side of my body. I?ve been experiencing dull fullness in my right ear and weird sensations on the right side of my head and neck to my upper back- right side. I?ve also been experiencing what feels like a shaky brain- it feels like my brain is literally shaking or spinning and it?s mostly on my right side. I?ve been having trouble concentrating and have been feeling very anxious and depressed. I?ve also been feeling extremely fatigued, even after sleeping. It?s been taking awhile for me to fall asleep because it feels like my brain is shaking. It?s been 6 weeks and I?m still experiencing these effects.
30 2021-07-27 mouth tingling Nausea; Dizziness/Lightheadedness; Tingling of the tongue; Elevated BP; This is a spontaneous report... Read more
Nausea; Dizziness/Lightheadedness; Tingling of the tongue; Elevated BP; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 04Apr2021 at 11:00 am (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had no known allergies to medications, food or other products. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) and drospirenone, ethinylestradiol (LORYNA) on an unknown dates, for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 11:15 am, i.e. after 10 mins of vaccination (as reported) the patient experienced nausea, lightheadedness, dizziness, tingling of the tongue. The nursing staff was immediately notified by the patient and was monitored for BP (blood pressure) and O2 (oxygen saturation test). The result of the tests was elevated BP (but remained within normal range) and for oxygen saturation it was unknown. The patient was provided with apple juice for sugar. Symptoms resolved within 15 minutes. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events nausea, lightheadedness, dizziness, elevated blood pressure and tingling of the tongue was recovered on 04Apr2021. No follow-up attempts are possible, information about batch number cannot be obtained.
30 2021-07-27 swollen tongue a minute or so after I vaccinated patient, I asked her to stay in store 15 minutes, she came back ... Read more
a minute or so after I vaccinated patient, I asked her to stay in store 15 minutes, she came back to the window stating she didn't feel well. I brought her back into the room and monitored her. She complained of pain moving up chest, "ball" in throat, then tongue swelling, severe pain in head and then tingling in the arms. She never had any difficulty breathing or speaking . EMS was called and came and patient refused treatment and left on her on with her parents
30 2021-07-28 eye swelling Patient called hospital call center. Pt stated pt got 2nd covid vaccine Pfizer yesterday at her loca... Read more
Patient called hospital call center. Pt stated pt got 2nd covid vaccine Pfizer yesterday at her local pharmacy. Pt said pt feels left throat swelling, left eye and left collar bone swelling and pain(socre 7/10) when pt touches on left collar bone swelling area, body aches and sinus headache. Pt advised by to go to ED
31 2020-12-31 ear congestion C/O STUFFINESS IN EARS, 97.6, 122/88, 69.
31 2021-01-03 pain in jaw DEVELOPED SWOLLEN LYMPH NODES AND SORENESS ON NECK AND JAW (LEFT SIDE). WENT TO THE ER AND IS FOLLOW... Read more
DEVELOPED SWOLLEN LYMPH NODES AND SORENESS ON NECK AND JAW (LEFT SIDE). WENT TO THE ER AND IS FOLLOWING UP WITH MD ON 1/5/21
31 2021-01-04 mouth numbness numbness of the throat and back of the tongue
31 2021-01-05 lip itchiness, mouth tingling Ten minutes after Covid vaccine begin to feel "itchy" , lips tingling/itchy; dry heaving, chest pres... Read more
Ten minutes after Covid vaccine begin to feel "itchy" , lips tingling/itchy; dry heaving, chest pressure.E rythematous rash on face. Evidence of excoriation on neck and upper chest. No shortness of breath Rapid response team called and transported to ED. Received epinephrine, Benadryl, Pepcid, Zofran and Solu-Medrol. Discharged at 8:20 PM home. E Today she is experiencing: itching all over, lips tingling, legs and arms feel very heavy, weak. Will follow up with her healthcare provider MD @ Hospital.
31 2021-01-05 mouth itchiness, tongue itchiness At about 10 to 12 minutes after she received the vaccine she felt that her throat "felt numb" and ha... Read more
At about 10 to 12 minutes after she received the vaccine she felt that her throat "felt numb" and had trouble swallowing her own saliva. Approximately 30 minutes after the vaccine she noticed significant tongue and oral itching and then hoarseness. Vitals were normal. Did not notice any flushing, rash under skin or swelling. The symptoms all resolved after she received a dose of Benadryl (which she was able to swallow) followed by a dose of Zyrtec.   3 days after she received her injection she developed sore throat and body aches.
31 2021-01-05 oropharyngeal discomfort SCRATCHY THROAT , FULL FEELING IN BACK OF THROAT , TREATED WITH BENADRYL. OBSERVED AND RELEASED FR... Read more
SCRATCHY THROAT , FULL FEELING IN BACK OF THROAT , TREATED WITH BENADRYL. OBSERVED AND RELEASED FROM CLININC
31 2021-01-07 loss of taste All the covid symptoms - sore throat fever, headache; shortness of breath; no taste; fatigue; tested... Read more
All the covid symptoms - sore throat fever, headache; shortness of breath; no taste; fatigue; tested positive on the 23rd for Covid. 2nd dose: 1/6/2021 (received in right arm) - in am; adverse events started in the pm of the 6th: (6 Pm) - fever, chill, sweats, headache - all night into the following day for the headache; took tylenol LATE IN EVENING for fever and so no fever when I woke up 7th - took last night (7th) - still had chills and headache. (day two still) - HAS BEEN TAKING TYLENOL FOR24 HOURS BECAUSE HEADACHE IS BAD IF IT COMES ON day two - symptoms are better now; military - so was coming off covid protocol - so it complicated going back to work.
31 2021-01-07 eye swelling face was kind of swollen/swelling in her cheek and her face on the left side; swelling in her eye; T... Read more
face was kind of swollen/swelling in her cheek and her face on the left side; swelling in her eye; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1284, via an unspecified route of administration from 31Dec2020 to 31Dec2020 as single dose for COVID-19 immunization. The patient has no medical history. The patient's concomitant medications were not reported. On 01Jan2021, the patient experienced face was kind of swollen, have some swelling in her eye and her cheek and her face on the left side. The outcome of the event was unknown.
31 2021-01-07 mouth numbness, mouth tingling within 5 minutes of the vaccine administration patient had numbness/tingling of her lips, tongue, an... Read more
within 5 minutes of the vaccine administration patient had numbness/tingling of her lips, tongue, and face. She was given Benadryl, which she states improved her symptoms and she was able to sleep. This morning (day after vaccine) she states that her tingling feeling has returned to her face, lips and tongue and she feels a globus sensation and constriction within her throat. She has taken a benadryl this morning with no improvement. Patient was recommended to seek care in the ER.
31 2021-01-07 lip itchiness Approximately 18 minutes post injection, patient experienced itching and whelps on opposite limb as ... Read more
Approximately 18 minutes post injection, patient experienced itching and whelps on opposite limb as injection site. Diphenhydramine 25 mg chewable tablets given. Itching continued into legs and skin above lips. Prednisolone 40 mg liquid given. After 10 minutes, itching and whelps improved. Patient monitored for a total of 1 hr post injection.
31 2021-01-07 lip swelling, eye swelling Eye swelling, lip swelling and rash.
31 2021-01-07 mouth swelling Pt recieved injection at 1000, began feeling dizzy around 1045, pts sxs continued to worsen with nau... Read more
Pt recieved injection at 1000, began feeling dizzy around 1045, pts sxs continued to worsen with nausea, and mouth swelling noted. Pt returned to the vaccine clinic and was escorted to the ED. In the ED she was evaluated by the provider, and given epinephrine, solu-medrol, and benadryl, and is now recovered from her reaction and being observed in the ED.
31 2021-01-07 mouth swelling Pt had reported feeling dizzy, then mouth swelling, and nausea. Pt was treated by ED staff after pr... Read more
Pt had reported feeling dizzy, then mouth swelling, and nausea. Pt was treated by ED staff after presenting back to vaccine clinic site. Pt received Epinephrine, Solu-medrol, and Benadryl, and is no longer experiencing any sxs.
31 2021-01-07 mouth tingling, dry mouth diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness ... Read more
diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness on chest; Chest tightness; Lightheaded; possible tongue swelling; possible tongue swelling (felt heavy after vaccine); dry mouth; sore throat; This is a spontaneous report from a contactable nurse (patient) who reported for herself that a 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration, on 20Dec2020 14:15 at left arm/arm right (pending clarification), single dose for COVID-19 immunization. Medical history included factor II, history of melanoma. She has no known allergies. She was not pregnant at the time of the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), ibuprofen (MOTRIN), multivitamin. Nurse reported administering COVID-19 vaccine at hospital, experiencing tachycardia, high blood pressure, redness on chest, chest tightness, lightheaded, possible tongue swelling (felt heavy after vaccine), arrhythmia, dry mouth, sore throat (after leaving emergency department) at 14:30 on 20Dec2020; After one day, she experienced diarrhea, headache, lower back pain and fatigue since 21Dec2020. Fatigue lasting for several days. Adverse events resulted in emergency room/department or urgent care (pending clarification). Nurse received intravenous diphenhydramine hydrochloride (BENADRYL) and fluids as treatments. Nurse assessed the events as non-serious. Nurse also reported that, prior to vaccination, she was not diagnosed with COVID-19; since the vaccination, she has not been tested for COVID-19. She did not receive other vaccine in four weeks. Outcome of fatigue was not recovered, outcome of the rest of the events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the tachycardia, high blood pressure, arrhythmia and the other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-01-07 mouth tingling within 5 minutes after the vaccination I got hot an flushed all over. I was nauseated and my BP wen... Read more
within 5 minutes after the vaccination I got hot an flushed all over. I was nauseated and my BP went to 166/80 HR 160s. My body began to feel tingly all over even my tongue but it never swelled. I was given 25mg of benedryl and monitored for 30 minutes and finally my body began to normalize and my BP went down to 130/70. I went back to work but when I got home I took more benedryl because my body still had the same tingly feeling. After about 24 hours all symptoms had subsided.
31 2021-01-07 mouth tingling within about 5 minutes after the injection I got warm and flushed feeling all over my body, my body ... Read more
within about 5 minutes after the injection I got warm and flushed feeling all over my body, my body started feeling tingly all over even my tongue, but it never swole. My HR went up to the 160s, my BP was elevated to like 166/80. I was given 25mg benedryl, which calmed the flushed feeling and I was monitored for about 30 minutes and finally my BP and went back down to around 130/70 and my body normalized out besides the tingling which lasted the remainder of the day. I had a little nausea. I went back to work and finished out the day. I took more benedryl when I got home to help with the tingling feeling which finally deminished after about 24 hrs.
31 2021-01-07 sensitivity to light I received my first dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness an... Read more
I received my first dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 12/24-30 fatigue, malaise. 12/31-1/4 Increased fatigue and malaise, migraines, body aches, intermittent dry cough, lightheadedness, photophoibia. 1/5-1/8 Intermittent lightheadedness, slowly improving body aches.
31 2021-01-07 vision blurred blurriness on the right eye with consistent optic neuritis; read up on transverse myelitis that may ... Read more
blurriness on the right eye with consistent optic neuritis; read up on transverse myelitis that may be related to her condition; blurriness on the right eye with consistent optic neuritis; This is a spontaneous report from a contactable physician. This physician (patient) reported for self that the 31-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730), via an unspecified route of administration on Deltoid, Left on 20Dec2020 13:00 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. Reported she has a flu vaccine in Sep2020, and had no reaction to the flu vaccine. She clarified she has never had a reaction to a vaccination before. The patient received the vaccine last 20Dec2020 and has reported to have blurriness on the right eye with consistent optic neuritis since 24Dec2020. She has already consulted with an ophthalmologist who said her case was interesting and referred her to Pfizer. She is scheduled to have her second dose on 10Jan2021 and is asking if she should still take it. She also mentioned that she read up on transverse myelitis that may be related to her condition and is asking for any information we may have on this. Doctor reporting she is having a possible adverse event to the COVID-19 Vaccine. The patient clarified she received the COVID-19 Vaccine on Sunday, 20Dec2020 at approximately 1:00PM. Reported the COVID-19 Vaccine was administered at her employer. Doctor reported she is experiencing blurry vision in her right eye only, consistent with optic neuritis in Dec2020 (Medically significant). She said her right eye blurry vision gets worse after working out or showering. She said she has read some medical information that states some kind of autoimmune reaction, like transfer myelitis, may occur after receiving the COVID-19 Vaccine. The patient asked if she should get the second COVID-19 Vaccine, clarifying she is scheduled to receive her second dose on 10Jan2021. Clarified she started experiencing the right eye blurry vision on either 24Dec2020 or 25Dec2020. Treatment: Reported she saw an ophthalmologist, and the ophthalmologist said he didn't see anything concerning or not normal. She said the ophthalmologist referred her to see a neurologist, and to get a MRI of her head. She clarified her MRI appointment is on 19Jan2021. She clarified her ophthalmologist called her back 2 hours after she left her appointment. She said the ophthalmologist told her he found what she was experiencing to be interesting, as to when she received the COVID-19 Vaccine, and the start of her right eye blurry vision, and that he wanted her to get further evaluation. She said the ophthalmologist performed visual field testing, and took a fancy picture of her retina. No further details provided. Vaccination Facility Type was hospital. No Vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) required a visit to Emergency Room but AE(s) required a visit to Physician Office. Prior Vaccinations (within 4 weeks) was none. Patient's Medical History(including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was not provided. Relevant Tests included Visual field test, and picture of her retina. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events optic neuritis, vision blurred and myelitis transverse cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
31 2021-01-09 lip swelling Noticed burning in left forearm immediately after vaccine, within 1 min. Symptoms progressed to feel... Read more
Noticed burning in left forearm immediately after vaccine, within 1 min. Symptoms progressed to feeling hot, flushed, and tachycardia briefly around 5 min. 10 min developed a pressure in my chest, and dizziness. Within 20 min, developed itching, flushing and hives specifically on left arm, hand, and across chest. Within 45 min, both ears and forehead covered with hives. Hospital staff made me go to ED. Within ED hives continued to progress across the chest and bilateral arms and wrists. Received 50mg of Benadryl, and 40mg of prednisone. Symptoms improved but did not resolved. 3 hrs following vaccine, bilateral lip swelling. Took 40mg of percribed pred and 25mg of Benadryl again around 4pm. Within 12 hrs, significant diarrhea. Hives resurfaced on face, bilateral wrists, arms, and ears around 645 on the 12/29. Fever 100.3 noted on 12/29-12/30. Intermitted hives, and lip swelling remained until 1/1. Nausea diarrhea and body aches until 1/2.
31 2021-01-10 mouth numbness, eye pain it was debilitating for her at work; It even hurts to move the right eye in one direction and hurts ... Read more
it was debilitating for her at work; It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad.; pain in right leg and bottom sole of right foot; hurts to speak; numbness right upper side of lip; pins and needle feeling right upper quadrant of face; pain and dull aching right upper side of face; right hand numbness, wasn't able to feel anything; generalized headache; generalized muscle weakness and pain; generalized muscle weakness and pain; This is a spontaneous report from a contactable other hcp (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 at single dose in deltoid right for covid-19 immunization. There were no medical history or concomitant medications. The patient received the vaccine on 03Jan2021 and within 15 minutes had a generalized headache. Later that night she had generalized muscle weakness and pain, but really didn't think too much about it. The next day at work (04Jan2021), she had numbness on the right upper side of her lip and a pins and needle feeling in the right upper quadrant of the face. Had a lot of pain in the area as well on the right upper side of the face as well as a dull aching pain that lasted for hours. Later that day when using the computer and she was trying to reach for her mouse she noticed her right hand wasn't able to feel anything and that lasted about 20-25 minutes. Kept slapping the mouse with her hand, but could not feel anything, her hand went numb. Yesterday (05Jan2021), she had the same pins and needle feeling in the same area of the face and that dull achy feeling and it occurred for hours and it was very kind of debilitating for her at work. Later that night she had pain in her right leg and felt the same way, that very severe achiness, which was the pins and needles feeling up and down the leg and underneath the right foot. All these symptoms tend to be on her right side and it definitely lasted for hours. It started about 1 and didn't end until 6-7pm. It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad. This morning (06Jan2021) she had to call out of work because at 3am the generalized headache, pain was unbearable. She was still experiencing the pain in right leg and bottom sole of right foot. She did not receive any vaccines the same day or 4 weeks prior. No problems with vaccines in past. She had made an appointment with a neurologist and will have a MRI done on Friday, 08Jan2021. No further details provided. All events required a visit to physician office. All events were reported as serious per medically significant. The outcome of all events was not resolved. The reporter considered all events were related to the vaccine. Information about Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-01-10 lip swelling Lip swelling with history of cosmetic lip fillers
31 2021-01-10 pain in jaw, toothache 0830 1/7/21 experienced rapid onset lightheadedness that lasted for a duration of 15 minutes before ... Read more
0830 1/7/21 experienced rapid onset lightheadedness that lasted for a duration of 15 minutes before resolving. From 0900 to 1600 experienced fatigue and heaviness that prevented me from working that day. From 1600 to 2000 I felt "normal". At 2100 I went to bed with chills and overall malaise, awoke at 0000 1/8/21 with a fever of 101 F. Throughout the night I experienced severe body aches and a headache that made my teeth and jaw ache 7/10 on the pain scale. Tylenol 500mg taken at 0500 1/8 with relief. Fatigue/weakness experienced until 1700 on 1/8/21 after which I felt like myself again. In total, 2 days of work missed as a result of symptoms.
31 2021-01-10 vision blurred I felt flushed and light headed after receiving the vaccine but as the day went on I felt worse. By ... Read more
I felt flushed and light headed after receiving the vaccine but as the day went on I felt worse. By 2030 I had severe full body chills and could not stop shaking. I had a severe headache/migraine. Every muscle in my body hurt. This continued on for the entire night. Got tested for COVID the next morning with the rapid results and the symptoms continued with the muscle aches and severe headache. Vision became blurry and I became very dizzy. Slept for 8 hours during the day on 1/7/2021 and then slept another 12 hours that night. The body aches and headaches continued until 1/8/2021 at which the symptoms finally subsided
31 2021-01-11 mouth tingling, taste impairment I had a metallic taste in my mouth and slight tingling of the tongue blade with onset 10 mins follow... Read more
I had a metallic taste in my mouth and slight tingling of the tongue blade with onset 10 mins following vaccination. This lasted about 3 hours.
31 2021-01-11 mouth tingling, mouth numbness 4 minutes after the vaccine I had difficulty swallowing and numbness and tingling in my lips. The di... Read more
4 minutes after the vaccine I had difficulty swallowing and numbness and tingling in my lips. The difficulty swallowing lasted approximately 2 minutes and the numbness/tingling lasted about 20 minutes. Both self resolved.
31 2021-01-12 eye twitching So on the night of the 25th, my lymph nodes were so swollen, my left eye was twitching, low grade fe... Read more
So on the night of the 25th, my lymph nodes were so swollen, my left eye was twitching, low grade fever that was constant from Friday through Sunday. My left leg was twitching and also my left bicep. I had left sided twitching that was off and on. I had fatigue and some aching in my knees.
31 2021-01-12 mouth tingling Client administered 0.3 mL Pfizer COVID19 vaccine via IM to left arm at apx 1525. At apx 1545 clie... Read more
Client administered 0.3 mL Pfizer COVID19 vaccine via IM to left arm at apx 1525. At apx 1545 client verbalized complaint of tingling sensation to lips and face. Client denied any difficulty breathing. Client administered 50mg of Diphenhydramine via IM to right arm at apx 1546. 1547 BP= 117/70; HR = 98bpm; RR = 18; temp = 97.2. Client verbalized tingling sensation lessening at apx 1550. 1552 BP = 113/69; HR = 92; RR = 15; temp = 97.2 At 16:00 client verbalized tingling sensation had completely subsided. Client denied any difficulty breathing. Client declined transport to ED and instead called friend to pick her up as she was too drowsy to drive per Dr.
31 2021-01-12 tongue itchiness Pt developed post COVID vaccine side effects at 1000. Pt received COVID vaccine at 0932 by LVN. ... Read more
Pt developed post COVID vaccine side effects at 1000. Pt received COVID vaccine at 0932 by LVN. Pt complained of a numb throat, and said, "I cant seem to swallow my saliva well." This writer did an immediate assessment of patient's throat with flashlight, and no swelling, abnormal discharge, or discoloration noted. Pulse-ox that was available on hand was used on pt, and sats were 96% and HR 78. MA on site was asked to grab a complete VS machine for somewhere stat, for there was none on site. This writer reassured pt was going to be okay and to breathe normally, for assessed pt was breathing fast. This writer called every doctor listed on the "Contact List for COVID Vaccine Clinic," but there was no response. This writer then called Urgent Care and Minor Injury Clinic, but the doctors were busy with patients. Asked MAs from those areas to have a doctor call immediately for a patient here was symptomatic. Once VS got here, VS were taken, and pt was assessed again. Pt said there was no more numbness in her throat, but tongue was feeling itchy, and her body temp went from hot to cold. Intitial VS: Temp: 98.3 BP: 122/80 HR: 77 O2: 99% RR: 18 Dr from Urgent Care finally called. Background story given, and she ordered Diphenhydramine Cap 25mg (Benadryl) which this writer had on hand in the emergency kit. Order was on computer, but could not acknowledge or scan, so order detail was printed, and pt and I signed form together. Benadryl given at 1025. Dr also suggested that ID doctor be called. At 1030, I got a hold of Dr., gave her a background story, and she advised that the pt stay for another 30 mins to be observed and she would come see the pt. Dr. arrived at 1100, assessed the patient, and ordered Cetrizine Tab 10mg (Zyrtec) to give to pt, which Dr. had to get from another department. There was no Zyrtec available in emergency kit. Again, order was on computer, but could not acknowledge or scan, so order detail was printed, and pt and I signed form together. Zyrtec given at 1128. An additional Zrytec Tab 10mg was given at same time at 1128 "for home use" per Dr and per her order. VS set #2 taken at 1133 Temp: 98.1 BP: 133/94 HR: 63 O2: 100% RR: 16 Dr suggested that she schedule an appt to see an allergist and to get an allergy test done prior to the next dose of the COVID vaccine. Patient was feeling a lot better and more at ease. Pt left comfortably with no symptoms at 1200.
31 2021-01-13 chewing disorder, lockjaw Extreme lockjaw unable to barely talk or chew
31 2021-01-14 loss of smell, loss of taste Body aches, chills, feverish, fatigue, sneezing started on evening of 12/23. 12/24 - loss of taste, ... Read more
Body aches, chills, feverish, fatigue, sneezing started on evening of 12/23. 12/24 - loss of taste, body aches but improved, sneezing. 12/25-cough, severe nasal and sinus congestion, no smell or taste, sneezing. 12/26-congestion, no smell and improved taste, achy, scratchy throat. Sought medical advise on 12/26 primarily due to congestion and scratchy throat.
31 2021-01-14 dry mouth 1/12 0715: Received Pfizer covid-19 vaccine dose 2 at end of shift. Went home to sleep after waiting... Read more
1/12 0715: Received Pfizer covid-19 vaccine dose 2 at end of shift. Went home to sleep after waiting 15 min. 1630: Woke up. Felt more tired than usual. 1900: Arrived at work. Felt fatigue and sore arm. 2000: Felt sore arm, fatigue, and mild HA. Drank coffee and this helped with fatigue and HA. 2100: Mild nausea starts. Still have sore arm. Less fatigue, no HA. Still able to eat with the nausea. 2200: Developed chills. I was putting up curtains in an isolation room and had to pause halfway through due to being short of breath as if I'd done something strenuous. I then was short of breath again walking specimens to lab, which is unusual for me. Walking samples to lab involves walking 400 ft and going up and down 1 flight of stairs. 2300: Coworkers keep asking me why I'm always out of breath. They are concerned. Chills are worse now and I go from feeling normal to feeling cold. My hands are like ice and I am gripping my arms to keep warm. I walk 2 samples to lab and each time I am dizzy on the way back. By the 2nd time I have to hold the wall to keep balance. I can no longer hide the side effects and a coworker offers me 650mg Tylenol. I gladly accept. I measure my spO2 and it is 97%. 1/13 0530: I am almost back to normal other than feeling fatigued. 0815: I get home and go to bed. My feet are ice cold so I have to wear socks, but my hands feel normal temperature. I feel like my blanket isn't warm enough. 1330: I wake up and feel absolutely miserable. I am going between having chills to having a hot flash. I can't seem to will myself to leave bed. I'm pretty sure I have a fever, which I haven't had in over 10 years. My mouth is completely dry. 1400: I manage to roll out of bed and take my temperature, which is 101.3F. I feel an overall malaise and keep getting periodic hot flashes, but manage to make it downstairs and I mix 1 liquid IV electrolyte packet w/ 24fl oz. water. I drank the whole thing. I also cooked myself some dumplings and 1 waffle w/ maple syrup due to feeling much hungrier than usual. 1430: I take 1000mg Extra Strength Tylenol after eating. 1830: I feel almost normal except for significant fatigue and go to bed. 1/14 0430: I wake up and feel completely normal. No fatigue. Go about my day as normal. 1545: Suddenly I feel lightheadedness and mild HA. Have trouble with inattention (ex. not following w/ conversation or forgetting what people just said, or listening but not registering, or can't find the words to respond or answers to a question.). I take my Vitals: 117/95, spO2 85%, HR 63. I then try taking a couple deep breaths and spO2 increases to 98% and lightheadedness and HA go away. Then a few minutes later lightheadedness and HA begin again and spO2 is 80-90%. Then I take 2 deep breaths and spO2 is 98% and HA and dizziness improves. This repeats several times and I grow concerned. My hands are cold and the pulse oximeter is $30 from Amazon. However, I used the pulse ox on my mother and she was 97% consistently every time without fail. I also used pulse ox on myself when perfectly healthy and same thing it was 98%+ every time. This is why I was now worried. 1630: I take Tylenol since this seems to have helped with any and every symptom I've had so far and book an Urgent Care appointment. 1700: I get up to take a shower and feel extremely dizzy to the point where I'm worried I might fall. I stumble into the bathroom holding the wall. I take spO2 and it is 87%. 1800: I show up to Urgent Care and after the shower I feel my hands are warm now. At Urgent Care they are using pulse oximeters and I am spO2 99% and HR 64. So they chalk it up to my crappy Amazon pulse ox and they tell me to hang in there. Perhaps if I had not taken a shower before going there it may have been a different story? Hard to say now. Also the Tylenol may have started to work by then. 2200: I am still inattentive, spacey, lightheaded, and fatigued. I then fell asleep on the couch without realizing. 1/15 0230: I wake up and feel fatigued with brain fog, but no more lightheadedness. 0630: I go back to bed because I'm too sleepy.
31 2021-01-14 mouth numbness numbness of tongue after the vaccine shot,code rapid response and employee went to ER and was given ... Read more
numbness of tongue after the vaccine shot,code rapid response and employee went to ER and was given benadryl and IV solumedrol
31 2021-01-14 lip swelling Patient did not report an adverse reaction following dose #1. Within minutes of receiving vaccine d... Read more
Patient did not report an adverse reaction following dose #1. Within minutes of receiving vaccine dose #2, patient c/o flushing. VS 131/88, 100% RA, Hr 102, temp 97.5, RR 20, no SOB nor difficulty breathing. About 10 minutes post dose, patient reported feeling anxious, BP 130/87, HR 107, RR 20. Some swelling of lip on inner side. About 20 minutes post dose, patient started coughing and c/o itchy throat. Transported to ED where patient received epinephrine, Benadryl, solu-medrol, famotidine, NS 500mL bolus. Symptoms resolved and after 3.5 hours observation was discharged. After the patient was transported to the ED, a jar of nuts was found in the vicinity of where the patient was sitting post-vaccination.
31 2021-01-14 mouth tingling, feeling of choking Sensation of heat and numbness tingling in Chest up into throat mouth and lips, palpitations, dizzin... Read more
Sensation of heat and numbness tingling in Chest up into throat mouth and lips, palpitations, dizziness, elevated heart rate, chills, tingling in extremeties, burning in throat ; started aprroximately two minutes after administration, took benedryl and water, waited another 15 minutes where signs and symptoms started to subside a little bit and thought I was okay but then came back at about 25 minutes post vaccine where it was decided to go to emergency department.
31 2021-01-17 lip swelling, mouth tingling, eye swelling following day around 7pm lip swelling; tongue tingling; body hives; chills; After first dose of Covi... Read more
following day around 7pm lip swelling; tongue tingling; body hives; chills; After first dose of Covid vaccine face flushing; increased HR about 45 mins. went away on its own; hours later left eye swollen; This is a spontaneous report from a contactable Nurse (patient). A 31-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 15:00 at single dose on Left arm for covid-19 immunisation. Medical history included Known allergies: Shellfish, IV contrast dye, Penicillin. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced after first dose of covid vaccine face flushing; increased hr about 45 mins. went away on its own since 06Jan2021 16:00; hours later left eye swollen on 06Jan2021; following day around 7pm lip swelling, tongue tingling, body hives, chills on 07Jan2021 19:00. The patient underwent lab tests and procedures which included heart rate: increased on Jan2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Ae treatment: Steroids, IV fluids, Benadryl. No COVID prior vaccination. No COVID tested post vaccinate. This report was reported non-serious. The event outcome of increased hr about 45 mins. went away on its own was recovered on 06Jan2021 16:45, outcome of other events were not recovered.; Sender's Comments: Based on the compatible time association, the serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-01-18 loss of taste, loss of smell I tested positive for COVID 19 after. Fatigue, sore throat, chills, headache, total body aches, naus... Read more
I tested positive for COVID 19 after. Fatigue, sore throat, chills, headache, total body aches, nausea, vomiting, loss of taste and loss of smell, chest pressure, and dizziness. Worsened after pervious VAERS report but now has resolved.
31 2021-01-18 lip swelling, mouth tingling Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine howev... Read more
Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine however did develop symptoms within one minute of completing a run. Developed b/l hand swelling and tingling, diffuse hives and itching, tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids, Benadryl and IV steroids. This is similar to previous reactions I have had to running previously. Symptoms resolved within one hour after treatment in ED.
31 2021-01-19 eye itchiness Approximately 8 hours after receiving the vaccine she began noticing itchy throat, eyes, ears, nasal... Read more
Approximately 8 hours after receiving the vaccine she began noticing itchy throat, eyes, ears, nasal congestion and sneezing. These symptoms lasted for about 48 hours.
31 2021-01-20 lip swelling, eye swelling Had to wait longer immediately post vaccine due to nausea and flushing. About 7 pm that even slight ... Read more
Had to wait longer immediately post vaccine due to nausea and flushing. About 7 pm that even slight soreness in arm. Woke next morning with swollen lips, face, eyes, and extremities. This seemed to go away on its own around 1pm on Friday but the. Developed severe headache and vertigo and extreme fatigue. This lasted for the next 40 hours. By Sunday mid day I felt great.
31 2021-01-20 mouth tingling, eye itchiness, mouth numbness Within minutes and almost instantaneously, as the shot was being injected, my arm tingled. Then it ... Read more
Within minutes and almost instantaneously, as the shot was being injected, my arm tingled. Then it moved to my mouth and tongue. The roof of my mouth, and tongue became numb. I needed to think really hard how to swallow. It was like I could not figure out how to work that muscle. I took benadryl, to ease symptoms. It helped but did not take it away. Next day, mouth and tongue still numb, and my ears, eyes, nose and throat were itchy. My external skin was also itchy. My doctor put me on a steroid pack. 4 days later, I am doing much better still not 100% percent myself, but very close to being back to normal. Still have slight sensation in tongue.
31 2021-01-20 tongue disorder, swollen tongue Was monitored for approx 15 min, and released. Returned to vaccine clinic approx 15 mins later with ... Read more
Was monitored for approx 15 min, and released. Returned to vaccine clinic approx 15 mins later with bumps on tongue, and swelling. 50 mg Benadryl given. BP 115/95, however pt stated she takes lisinopril at home
31 2021-01-22 feeling of choking, lip swelling, mouth tingling Angioedema, lower lip swelling, lightheadedness, throat tightness, tingling lips, tongue, throat an... Read more
Angioedema, lower lip swelling, lightheadedness, throat tightness, tingling lips, tongue, throat and difficulty swallowing.
31 2021-01-24 ringing in ears About 15 minutes after receiving vaccine symptoms started. Nauseous, dizziness, chest pain, shortne... Read more
About 15 minutes after receiving vaccine symptoms started. Nauseous, dizziness, chest pain, shortness of breath, body aches (extreme), joint pain especially in hips and knees, extreme fatigue, headaches, ears constantly rang. Rash on my arm where I received it went down to my elbow and up to my shoulder and on to my upper back, about 3 hours for it show up. It red, raised and bumpy and it felt hot. This lasted for 4 days. I was very pale and my eyes were sunken in. I literally felt like I was ran over by a vehicle. I was sleeping for about 15 hours a day. I kept getting chills then I profusely sweats then it switch to freezing cold and back and forth between the two. I took Tylenol and Benadryl to control symptoms but still felt miserable. The symptoms all stayed with me to the end. I still do not feel 100%, I am still having ringing of the ears, moderate body aches and headaches. Someone else said they still see the rash but I cannot really tell. I was also having trouble focusing for a few days after receiving the vaccine, I felt highly medicated not the fun high the bad high
31 2021-01-24 ringing in ears About 15 minutes after receiving vaccine symptoms started. Nauseous, dizziness, chest pain, shortne... Read more
About 15 minutes after receiving vaccine symptoms started. Nauseous, dizziness, chest pain, shortness of breath, body aches (extreme), joint pain especially in hips and knees, extreme fatigue, headaches, ears constantly rang. Rash on my arm where I received it went down to my elbow and up to my shoulder and on to my upper back, about 3 hours for it show up. It red, raised and bumpy and it felt hot. This lasted for 4 days. I was very pale and my eyes were sunken in. I literally felt like I was ran over by a vehicle. I was sleeping for about 15 hours a day. I kept getting chills then I profusely sweats then it switch to freezing cold and back and forth between the two. I took Tylenol and Benadryl to control symptoms but still felt miserable. The symptoms all stayed with me to the end. I still do not feel 100%, I am still having ringing of the ears, moderate body aches and headaches. Someone else said they still see the rash but I cannot really tell. I was also having trouble focusing for a few days after receiving the vaccine, I felt highly medicated not the fun high the bad high.
31 2021-01-27 mouth lesion 31 y.o. female with reported PMH of asthma who presents for SARS-CoV-2 vaccination Pfizer Dose #1. T... Read more
31 y.o. female with reported PMH of asthma who presents for SARS-CoV-2 vaccination Pfizer Dose #1. Ten minutes after receiving the vaccination, the patient began to experience itching and hives. The patient was brought back to the monitoring area and vital signs were checked and stable. The patient reports eating lunch before the vaccine appointment. The patient was given bottled water. Patient's hives and itching worsened, spreading to her chest, mouth, and arms. She was given dexamethasone 8mg IV, benadryl 50mg IV and famotidine 40mg PO. Symptoms persisted and she was transported to the ED.
31 2021-01-27 taste disorder Some fatigue and arm pain the day after the vaccine. Starting 1/17/21 she had intermittent burning i... Read more
Some fatigue and arm pain the day after the vaccine. Starting 1/17/21 she had intermittent burning in her scalp. The following day she also started having a weird taste in her mouth. These symptoms continued and a few days after she also started having intermittent numbness and tingling in her face. The face parasthesias stopped on 1/23 or 1/24. The weird taste in her mouth is still intermittent but less frequent. The scalp irritation has mostly resolved.
31 2021-01-28 feeling of choking Immediate dizziness, burning/tingling feeling in throat that descended into chest
31 2021-01-29 vision blurred . She received the second covid pfizer vaccine 1/29/21. Within minutes post vaccine she had bilate... Read more
. She received the second covid pfizer vaccine 1/29/21. Within minutes post vaccine she had bilateral hand arm tingling. She stayed longer for observation and the provider did a brief exam which was normal. The paresthesias have persisted but now only in bilateral 4th to 5th digits. Severe, 8-10 HA began 7-8 hours later and has persisted in severity of 8/10 at worst and 6/10 this morning as she slept better through the night. It is located in the left orbit, left frontal area, throbbing, persistent, causing nausea and vomited 4 times since onset. Her vision is intermittently, "fuzzy" like she as if she does not have her glasses on only in the left eye. This comes and goes and seems to be present as the HA worsens. She has a hx of menstrual triggered headaches that resolve with meneses and just with OTC treatment. No photophobia. She has taken IBU 400mg q 8 hours, APAP 1g last night, melatonin 10 mg last night to sleep. Did not work her night shift last night due to the vision and HA she did not think she would be able to perform functions of her job. She also has flu Like symptoms of body aches, tired, no fever. Admits her anxiety is making the symptoms worse.
31 2021-01-31 lip swelling Tingling; felt itchy; swelling of the lips; This is a spontaneous report from a contactable healthca... Read more
Tingling; felt itchy; swelling of the lips; This is a spontaneous report from a contactable healthcare professional. A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), via an unspecified route of administration in the left arm on 09Jan2021 09:30 at single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to vaccination), penicllin allergy, and shrimp allergy. Concomitant medications included cetirizine, fexofenadine and triamcinolone. On 09Jan2021 11:00. the patient experienced tingling, felt itchy and experienced swelling of the lips. Therapeutic measures were taken as a result of the events that include Benadryl and famotidine. Clinical outcome of the events was recovered on an unspecified date.
31 2021-01-31 lip swelling Full body hives, swollen bottom lip. Treated with benadryl, pepcid and prednisone.
31 2021-02-01 eye swelling, eye itchiness Received #2 dose of Pfizer Covid19 Vaccine on 1/08/21 at 10 AM. Approximately 12 hours later she wok... Read more
Received #2 dose of Pfizer Covid19 Vaccine on 1/08/21 at 10 AM. Approximately 12 hours later she woke up with right eye pruritus with sensitivity, maculopapular erythematous rash and itching over left cheek to temple. She was rubbing at her eyes and did develop local swelling around the right eye. She treated herself with benadryl and advil. Her swelling and eye sensitivity decreased later that day but she developed a fixed itchy maculopapular rash on btl forearms (pictures in chart). She works in the ED as a technician and was seen during her shift 36 hours post shot. Diagnosed with a possible delayed reaction to the vaccine and discharged with prednisone, allegra, hydroxyzine. Symptoms have resolved except for residual hyperpigmentation over areas on forearms where the rash was and still feels itchy, though this increased after stopping antihistamines for her visit. She reports no episodes of lightheadedness/syncope, increased nasal congestion, difficulty breathing post vaccine. She has no history of anaphylaxis or allergic reaction to prior vaccines.
31 2021-02-01 extreme sound sensitivity, pain in jaw, ear pain, hearing loss Sore left arm with tenderness both series for 2 days . Two weeks after first vaccine, right-sided ea... Read more
Sore left arm with tenderness both series for 2 days . Two weeks after first vaccine, right-sided eachaches with mild headaches on right began. Prescribed ofloxacin 0.3% otic solution for a week. However, after this and my 2nd vaccine it progressively worsened with pain radiating to right jaw, more persistent and sharp right-sided headaches, blockage of hearing out of my right ear, hearing a pulsatile artery near my right ear mainly at night, and worsening earaches. Self-removed ear wax with an Asian ear pick, and the sharp headaches became intermittent mild headaches and earaches more mild. I was able to hear better but after a few hours my hearing was blocked again. I removed more wax again, but hearing was blocked again after a few hours, but this time, jaw pain went away. Went to see an ENT MD. He removed more right earwax and prescribed me "Neomycin and Polymyxin B Sulfates and Hydrocortisone 1% Otic suspension" for 10 days and sulfameth/trimethoprim 800/160MG TB (10 tablets) over 5 days. After a few days, I was completely relieved of all my symptoms. He then prescribed me another ear solution for the yeast in my ears, which I haven't started yet. Additionally, after my second vaccine, I had a cramp in my upper mid back for a day and weakness/fatigue for 2 days.
31 2021-02-01 visual impairment Approximately 2am of 01/29/2021 I became very over heated for about one hour. Around 3am I then beca... Read more
Approximately 2am of 01/29/2021 I became very over heated for about one hour. Around 3am I then became incredibly cold and shaking. Around 4am I got out of bed and stood for a few moments, then walked slowly around my room making my way to our bathroom. I noticed my vision was not right, almost like a fisheye affect and I felt dizzy. I made it to our master bathroom and sat down on a chair for a few moments before I completely passed out. I fell forward, face first on to the bathroom floor hitting the left side of my head. When I regained my conscious I was weak and shaking and was unable to call out to my husband. I slowly pulled myself up to the toilet trying to make some noise and my husband then came to my aide. As he talked I noticed his voice sounded much farther away than it really was. I also had a difficult time cognitively answering his questions about how I felt. I was pale, clammy, still shaking. This episode from the time I left my bed from the time my husband walked me back to the bed was about 45 minutes. My husband took my temp and I did not have a fever. The next five hours I alternated between feeling very cold and very hot. I spent the next 24 hours feeling completely depleted. I rested as much as I could and had a greater than normal appetite.
31 2021-02-02 tongue itchiness Tongue started itching. Benadryl 25 mg given. Assessed and kept 30 minutes. Pt states that she felt... Read more
Tongue started itching. Benadryl 25 mg given. Assessed and kept 30 minutes. Pt states that she felt better and discharged to home.
31 2021-02-03 lip swelling, eye swelling Hives Lips swelling Eyes swelling Itchy skin
31 2021-02-07 mouth itchiness Itchy mouth, headache for 48 hours, low energy/generally felt unwell.
31 2021-02-08 taste impairment black outs; Severe migraine; full body shakes; soured; delayed jumbled speech; loss of memory; nause... Read more
black outs; Severe migraine; full body shakes; soured; delayed jumbled speech; loss of memory; nausea; motor control issues; This is a spontaneous report from a contactable consumer reported for herself. A 31-year-old female patient (not pregnant at the time of vaccination and event onset) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration on 25Jan2021 10:00AM at single dose in right arm for covid-19 immunization, immunized in hospital. Medical history included obesity, anxiety, post-traumatic stress disorder (PTSD), insomnia, allergy to walnuts pecans. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonidine, fish oil and multi vitamin. The patient previously received the first dose of bnt162b2 lot number: EL1284, on 04Jan2021 12:00 PM at single dose in left arm for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously also received morphine and codeine, experienced allergy. The patient experienced sever migraine, black outs, full body shakes, soured, delayed jumbled speech, loss of memory, nausea and motor control issues, from 26Jan2021 11:30 PM. The events resulted in emergency room/department or urgent care. It was unknown if treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The case was reported as non-serious.
31 2021-02-08 mouth numbness, mouth tingling My lips, face, and neck went tingly and semi-numb. It's a feeling similar to when your foot falls as... Read more
My lips, face, and neck went tingly and semi-numb. It's a feeling similar to when your foot falls asleep.
31 2021-02-08 tunnel vision Received around 11am, some dizziness and tunnel vision about 10 minutes after while sitting, resolve... Read more
Received around 11am, some dizziness and tunnel vision about 10 minutes after while sitting, resolved within minutes. That evening: fatigue, mild arm sore Overnight: shaking, chills, fever, more severe arm soreness Following day: fatigue, fever, chills Beginning that evening: fever/chills resolved, started having palpitations and dizziness with some shortness of breath. Had these for about 3 more days primarily at rest. Self resolved Vaccine #2 3 weeks later: medicated with Tylenol and Motrin q4 hours, some breakthrough chills and joint pain overnight, mild arm soreness. Self resolved the following day. Have continued bruising at injection site 3 weeks later Continue to have some intermittent palpitations and dyspnea. Not present prior to vaccine 1.
31 2021-02-09 taste impairment Metallic taste in mouth, sweaty palms, Racing heartbeat. Started about 10 minutes after vaccination... Read more
Metallic taste in mouth, sweaty palms, Racing heartbeat. Started about 10 minutes after vaccination. Transferred to ED. Observed for 2 hours. No interventions required. Discharged from ED
31 2021-02-09 burning mouth syndrome Migraine - lasted 48 hours, medication (naproxen - 440mg every 6-8 hours) did not help. Sore Throat-... Read more
Migraine - lasted 48 hours, medication (naproxen - 440mg every 6-8 hours) did not help. Sore Throat-hard to swallow, sharp throat pain, still hurts 48 hours after vaccination. Tongue Pain-started on both sides towards back of tongue, 48 hours later, still hurts, can't eat/talk without being in pain. Right side feels better, left side in a lot of pain. Can't see any type of sore on tongue.
31 2021-02-09 lip swelling Systemic: Rash (other than injection site)-Mild, Systemic: Other- SWELLING OF UPPER LIP-Mild; lasted... Read more
Systemic: Rash (other than injection site)-Mild, Systemic: Other- SWELLING OF UPPER LIP-Mild; lasted 1 day
31 2021-02-09 mouth tingling Skin flushing of the neck and chest, felt very hot, then became lightheaded. Lips also felt like th... Read more
Skin flushing of the neck and chest, felt very hot, then became lightheaded. Lips also felt like they were tingling. Elevated blood pressure.
31 2021-02-10 lip swelling, mouth numbness, taste impairment Approximately 5 minutes following administration of my second dose of the Pfizer COVID 19 vaccine I ... Read more
Approximately 5 minutes following administration of my second dose of the Pfizer COVID 19 vaccine I began to have signs of lip numbness and lip swelling at the same time. No issues were noted with tongue or throat swelling associated with anaphylaxis. Additionally I noted an odd taste in my mouth, potentially metallic. I also experienced some abdominal pain at that time that passed in approximately 10 minutes. Discomfort and swelling feeling of the lips has persisted for the past 2 hours. Still no difficulty breathing, raving heart or other signed of anaphylaxis. Lips are only slightly swollen on outside appearance if at all but the feeling of swelling is noticeable
31 2021-02-11 mouth tingling, feeling of choking Patient complained of tingling on lips and throat. 25 mg oral Benadryl given, patient stayed in obse... Read more
Patient complained of tingling on lips and throat. 25 mg oral Benadryl given, patient stayed in observation 30 mins was still having symptoms and was taken or emergency department after.
31 2021-02-11 swollen tongue "? COVID vaccine reaction - pins and needles on tongue, tongue swelling"
31 2021-02-12 loss of taste, loss of smell, dry mouth Facial numbness and tingling, total loss of taste, appetite, and smell, muscle pain, nausea, increas... Read more
Facial numbness and tingling, total loss of taste, appetite, and smell, muscle pain, nausea, increased temperature, irritability, dried mouth Note: I was COVID positive back in December 2020, and I by the time I got the vaccine I was fully recovered, so there was no chance for Iris infection Vaccine date: 02-12-2021
31 2021-02-12 extreme sound sensitivity, sensitivity to light At approximately 8pm began feeling slightly nauseated. Tried going to sleep. Had some heart palpitat... Read more
At approximately 8pm began feeling slightly nauseated. Tried going to sleep. Had some heart palpitations and what felt like acid reflux/chest pains. Slight headache before bed. Took some Tums before going to sleep. at around 10:00 began vomiting horribly. Nausea went away slightly, but returned around 12am. Started vomiting again at 12am and also 2am. Started feeling severe flu like symptoms, severe body aches (especially in legs). Tried taking Tylenol at around 12, but believe it was out of my system once I vomited at 2am. Did not sleep - every time I moved I felt nauseous. Also heart pounding, stomach pain, body aches kept me awake all night. Took Tylenol again at around 7am. Severe body aches kept me in bed all day. Diarrhea. Severe head ache also gave me sensitivity to sounds and lights throughout the day. Took Tylenol again at around 2pm. Started feeling somewhat better around 7pm on Friday 2/12. Sat 2/13 felt extremely tired and no energy. Have some lingering diarrhea.
31 2021-02-14 vision blurred, ringing in ears About two hours after receiving the vaccination, I had severe dull pain in my entire leftarm which ... Read more
About two hours after receiving the vaccination, I had severe dull pain in my entire leftarm which received the vaccination. About 7 hours after the vaccination, I had extreme fatigue and slept for about 2 hours. I then got up to go to my neighbor's house (please note, it was about 4 degrees, -6 wind chill, outside at the time). When I got to the house, I stayed outside and smoked a cigarette for about 5 minutes. Upon going inside, I got extremely light headed, fatigued, my hearing went to "white noise" and a high pitched ringing, and my vision got blurry. I then left the house with assistance to head back home. While outside, despite the intense cold, I was dripping sweat in a matter of seconds. I continued sweating and experiencing effects akin to what is felt prior to passing out, for about 7-10 minutes. I then laid down and went to sleep. Third day, still some soreness in the arm, but only at the injection site. No more adverse experiences since.
31 2021-02-15 taste impairment Very strong Metallic taste in mouth appeared one week after receiving shot, and after receiving seco... Read more
Very strong Metallic taste in mouth appeared one week after receiving shot, and after receiving second dose, less than 3 hours later the metallic taste disappeared and has not returned. It had been constant from 1/27-2/12.
31 2021-02-16 swollen tongue, mouth numbness, mouth tingling Patient complained of numbness and tingling sensation in mouth and later complained of tongue swelli... Read more
Patient complained of numbness and tingling sensation in mouth and later complained of tongue swelling. Patient was observed, vital signs taken, given H20, O2 6L, and epinephrine. Patient then transported to Emergency Department.
31 2021-02-17 chewing disorder Left sided headache and facial pain. Shooting pain with any transitional movement and with chewing. ... Read more
Left sided headache and facial pain. Shooting pain with any transitional movement and with chewing. Throbbing over temple which worsens with neck extension or left rotation. Pain progresses down my neck and into my left shoulder. Pain occasionally goes towards my left eye. Pain has persisted since 1/21.
31 2021-02-18 mouth tingling, mouth numbness Pt developed lip and tongue numbness and tingling sensation 45 minutes after vaccine. Benadryl give... Read more
Pt developed lip and tongue numbness and tingling sensation 45 minutes after vaccine. Benadryl given PO with little to no improvement 30 minutes after dose. Pt transferred to ED for further monitoring
31 2021-02-21 tongue itchiness UNKNOWN WHICH VACCINE BRAND. Presented to the ED with chief complaint of a reported allergic reactio... Read more
UNKNOWN WHICH VACCINE BRAND. Presented to the ED with chief complaint of a reported allergic reaction with onset at 0300 this morning. Patient states she woke up feeling like her "airway was closing and her tongue was itching." She reports she received the second dose of the COVID vaccine 2 days ago. Patient took 25 mg of Benadryl upon onset of symptoms, however symptoms persisted. She then took another 25 mg without improvement and decided to come to the ED before her symptoms became worse. Patient states she developed generalized myalgias and nausea after the first COVID vaccine; received diphenhydramine, prednisone, famotidine in ED and for discharge
31 2021-02-21 vision blurred blurry vision (now resolved), dizzy/weak, sore arm. Side effects so bad that the patient was unable ... Read more
blurry vision (now resolved), dizzy/weak, sore arm. Side effects so bad that the patient was unable to drive home from work.
31 2021-02-25 inability to speak Light cough; Shortness of breath; Anaphylaxis; lost voice entirely; This is a spontaneous report fro... Read more
Light cough; Shortness of breath; Anaphylaxis; lost voice entirely; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 11Feb2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history was none. Patient did not have known allergies and did not have COVID-19 prior to vaccination. Concomitant medications included piroxicam (PAXIL) and lisdexamfetamine mesilate (VYVANSE). Patient did not receive other vaccines in four weeks. The patient experienced light cough on 11Feb2021 at 14:45 with outcome of recovering, shortness of breath on 11Feb2021 with outcome of recovering, anaphylaxis on 11Feb2021 with outcome of recovering, lost voice entirely on 11Feb2021 with outcome of recovering. The events required emergency room visit and physician office visit. The patient was hospitalized due to the events in Feb2021 for 1 day. Events were considered life threatening. Clinical course: light cough after half an hour from vaccination. Within 2 to 3 hours had lost voice entirely and was suffering from shortness of breath. Her primary physician told her to go to the emergency room or he was calling an ambulance because he said it sounded like anaphylaxis and that her life was in danger. Therapeutic measures were taken as a result of the events and included treatment with intravenous (IV) Decadron Pepcid and epinephrine. She received the 2nd dose on 21Feb2021 at 01:15 PM. Patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.
31 2021-02-25 visual impairment Near syncope on escalator - vision started to go black. BP 114/74, pulse 78, 99% O2.
31 2021-02-27 loss of smell, loss of taste 2 days after getting the shot, I lost my smell. 3 days after getting the shot, I lost my taste. My t... Read more
2 days after getting the shot, I lost my smell. 3 days after getting the shot, I lost my taste. My taste was gone for 5 days, and my smell was gone for 7 days.
31 2021-02-28 oropharyngeal discomfort Patient notified nurse within in 1 minute of vaccine administration of feeling of thickness in throa... Read more
Patient notified nurse within in 1 minute of vaccine administration of feeling of thickness in throat area. Patient monitored for 30 minutes in Covid Vaccine Clinic. Thickness in throat area started at 0850 and at 0910, patient stated of no longer having symptoms. Patient discharged from clinic.
31 2021-03-01 pain in jaw I started getting body aches and then I started getting severe pain in my lower jaw and upper teeth ... Read more
I started getting body aches and then I started getting severe pain in my lower jaw and upper teeth and side of my nose of my left side. It came on very comfortably. Rest of my body aches went away with Tylenol but this pain wasn't going away at all. I went to my dentist. He said everything was normal. I went to Immediate care on Tuesday to see if I had a nerve issue. They diagnosed me with a facial nerve pain - in the trigeminal nerve - the lower two branches - gave me steroids and Gabapentin. TMJ joint it would radiate to midline of mouth - when it wasn't the stabbing pain it felt like my mouth was being burned. It was a Medrol dose pack and took 6 days. By the next week the pain was completed gone.
31 2021-03-01 taste disorder, hearing loss, pain in jaw Jaw pain started on 2/19/21. Over 24 hours, it progressed to numbness and paralysis of the right sid... Read more
Jaw pain started on 2/19/21. Over 24 hours, it progressed to numbness and paralysis of the right side of the face. Patient was diagnosed with Bells Palsy on the evening of 2/20/21. As of today's date, patient is still experiencing periodic right sided facial paralysis, jaw pain, taste disturbances, and distorted hearing.
31 2021-03-01 ringing in ears Throat swelling, nausea, dizziness, high blood pressure right after receiving vaccine. Symptoms slow... Read more
Throat swelling, nausea, dizziness, high blood pressure right after receiving vaccine. Symptoms slowly got better until 3 days after where a headache appeared, and on the 5th day (today) it got worse. Headache feels like pressure all over, dizziness made me vomit, i have diarrhea, ringing in ears, pressure on head extends to neck and shoulders.
31 2021-03-02 vision blurred, eye pain 2 days after 2nd dose, developed headache feeling pressure behind eyes and vision out of focus at ra... Read more
2 days after 2nd dose, developed headache feeling pressure behind eyes and vision out of focus at random. Headache is current and has lasted longer than 8 days
31 2021-03-05 eye movement disorder RECEIVED VACCINE AT 359PM AND AT 415PM BECAME DIAPHORETIC, PALE, EPISODE OF URINE INCONTIENCE,MOMENT... Read more
RECEIVED VACCINE AT 359PM AND AT 415PM BECAME DIAPHORETIC, PALE, EPISODE OF URINE INCONTIENCE,MOMENT OF "RIGIDNESS AND EYES ROLLED BACK" AND "HAD A BRIEF EPISODE OF NON REPONISIVENESS AND CAME THRU" (PER EMS). PROVIDER ASKED TO EVALUATE PATIENT AFTER EPISODE, IN TENT. PER PROVIDER SEND PATIENT TO HOSPITAL OF CHOICE FOR HIGHER LEVEL OF CARE. NO PO MEDS PROVIDED TRANSFERRED AT 1641PM IN STABLE CONDITION( TO HOSPITAL) , IN STABLE CONDITION.
31 2021-03-05 mouth numbness, lip swelling pt return to store approximately 40 minutes ( per pt) after receiving the vaccine and told us that s... Read more
pt return to store approximately 40 minutes ( per pt) after receiving the vaccine and told us that she felt a knot in her throat and her lower lip was swollen and felt numb. Took pt into the vaccination room, took her blood pressure ( 125/82). There was no rash or hives. Pt was alert, oriented but complained that her throat still felt tight and there was a knot. Pt was asked to remove the mask so we could check for edema. Her lower lip appeared very swollen. We told her that it could be an allergic reaction and needed to administer the EpiPen and call 911- pt received 1 dose of epi pen 0.3mg into the left thigh through clothing at aroung 12:30 pm .We called 911 and continued to monitor patient while waiting for EMs to arrive. Her second BP was 122/75 after the EpiPen and she said the knot was still in her throat. EMS arrived very shortly after and took over. They told her that they would take her to a hospital to monitor her.
31 2021-03-08 conjunctivitis, eye discharge, lacrimation increased, eye irritation, eye swelling, bloodshot eyes Received vaccination 3/4 in the afternoon. Noticed left eye irritation/redness/swelling on 3/6 in t... Read more
Received vaccination 3/4 in the afternoon. Noticed left eye irritation/redness/swelling on 3/6 in the evening. Progressed through the evening to have lots of discharge and watery. Eye crusted shut morning of 3/7 and 3/8. Symptoms of redness/irritation/swelling continued. Diagnosed with pink eye morning of 3/9/21.
31 2021-03-08 eye swelling SWELLING ON EYES ,HOT FLASHES AND INCHING. WENT TO EMERGENCY ROOM SOLOMEDROL 125MGS IV,BENADRYL 50 M... Read more
SWELLING ON EYES ,HOT FLASHES AND INCHING. WENT TO EMERGENCY ROOM SOLOMEDROL 125MGS IV,BENADRYL 50 MGS IV AND PEPCID 20 IV. NEXT DAY WITH LESS SINTOMES.
31 2021-03-08 mouth tingling Tingly tongue, sensation level 5/10 or so. Took Benadryl and Claritin. Felt better after 2-3 hours.
31 2021-03-08 visual impairment "light headed, dizzy and then vision began to go out" No syncope, no numbness or tingling, able to ... Read more
"light headed, dizzy and then vision began to go out" No syncope, no numbness or tingling, able to self ambulate, no other symptoms noted. patient is pregnant but unknown of gestation, previous births, etc.
31 2021-03-09 vision blurred Post vaccine: 6 hours- very sore arm, migraine headache 12 hours- extreme fatigue, drowsiness, muscl... Read more
Post vaccine: 6 hours- very sore arm, migraine headache 12 hours- extreme fatigue, drowsiness, muscle aches, headache, blurry vision 12-72 hours- unable to function due to extreme drowsiness, fatigue (unable to care for child and operate a vehicle) 3 days to 10 days- continue to experience weakness, difficultly lifting things I would otherwise be able to, foggy brain, unable to recall certain words, difficulty staying awake and doing my job
31 2021-03-10 dry mouth Reported feeling tired, making a chewing like motion with mouth. Stated mouth really dry.
31 2021-03-13 lacrimation increased, sensitivity to light 2 hours after receiving the vaccine on Sunday, I had significant fatigue and sensitivity to light wi... Read more
2 hours after receiving the vaccine on Sunday, I had significant fatigue and sensitivity to light with watery eyes and a headache and was in bed all day. The next morning on Monday I woke with a pressure headache that was kept at bay with Advil. The headache stayed the same on Tuesday and Wednesday. By Thursday the headache was so uncomfortable I was having trouble working. It stopped responding to Advil and the pressure continued to increase on both sides of my head with sharp, shooting pains throughout that would come and go with the constant pressure. By Friday, I couldn?t co to use work and ended up calling into my PCP and advising them that I had a migraine that was very different from my normal migraines that I get (pain on left side behind eye, very nauseous, sensitive to light, always responds to OTC meds) and it wouldn?t respond to Advil and asked them to call in something. They called in generic version of Imitrex that evening; but since this migraine was so different than my normal pattern, I went to the ER on Saturday. They did a CT scan to make sure there were no brain bleeds and gave me IV magnesium and steroids. I declined the torodol and Benadryl. The headache was still there, but bearable finally when I left. It got worse again that evening and I ended up taking the imitrex at 3am and falling asleep, only to wake up at 7am with a skull splitting feeling. That feeling stayed for the next 4 days, slowly getting less intense. I was unable to workout any of these days (I workout for about an hour daily for the past 3 years) because it was extremely exacerbated by activity. I was not hungry. Finally on Thursday I felt more like my normal self but the headache remained slightly and now on Sunday all that is left is the sharp, shooting pains that come every so often and light sensitivity.
31 2021-03-17 lip swelling, lip itchiness Within 24 hours of first dose, swelling of lips have occurred and are continuing to swell. Tingling ... Read more
Within 24 hours of first dose, swelling of lips have occurred and are continuing to swell. Tingling and burning sensation present accompanied with itching around lips and face. Benadryl, Claritin and Pepcid are currently being taken to reduce swelling.
31 2021-03-17 vision blurred Patient waiting in observation for 15 min. 10 minutes into waiting patient waves down field ops who... Read more
Patient waiting in observation for 15 min. 10 minutes into waiting patient waves down field ops who caught patient in chair from falling. Observation nurse and charge notified. Vitals taken. 119/76, 98% o2, 76 pulse, 96.7 temp RR 20, lung sounds clear. Patient stated she felt sweaty and had blurry vision and decided to call for help. Patient asked to wait 30 min. Patient on floor, legs elevated, conscious and able to communicate. Mother came to assist. Patient sat up on floor and able to tolerate water. Vitals rechecked and stable. Vitals reassessed before leaving site 100/63, pulse 90, O2 97%, RR 18, temp 97.6. Patient states she feels much better and tolerates standing. Edicated to seek medical attention if symptoms return or worsen. Patient accompanied by mother and nurse to car without incident at 4:05 pm.
31 2021-03-20 mouth tingling, lip swelling @08;15 - Vaccinated @08:17 - lips tingling @08:19 - triage, lips mild swelling @08:27 - Zyrtec 10 mg... Read more
@08;15 - Vaccinated @08:17 - lips tingling @08:19 - triage, lips mild swelling @08:27 - Zyrtec 10 mg given @8:35 - numbness/tingling decreasing Vitals: 67 HR, 99% O2, 165/92
31 2021-03-20 ringing in ears Head pressure started occurring 3/3 and tinnitus started occurring 3/8. Both are still happening.
31 2021-03-21 oropharyngeal discomfort, mouth tingling Abdominal Pain, Dyspnea, Throat Irritation Narrative: 30 yo F with PMH multiple allergies, chronic p... Read more
Abdominal Pain, Dyspnea, Throat Irritation Narrative: 30 yo F with PMH multiple allergies, chronic pain syndrome, cervical and lumbar radiculopathy, and chronic plantar fasciitis, presenting with c/f anaphylaxis after receiving COVID-19 (Pfizer) vaccine. Had scheduled COVID-19 vaccine appointment at a medical center. Shortly after (about 1 minute) of administration she noted some GI upset initially and some dizziness on standing Then developed lip and finger tingling, some throat discomfort and tightness and SOB where she felt that she was not able to get any air out. Was instructed to come to the ED for further eval. Has an epi-pen at home but did not administer. She said this felt very similar to prior allergic reactions she has had in the past. In the ED, was tachycardic to the 120s, vitals otherwise wnl. Labs notable for Cr 1.3 (baseline 0.8), hypokalemia to 3.0, d-dimer and trop neg. Given solumedrol 125mg IV, Benadryl 50mg IV and 0.5mg Ativan and symptoms significantly improved. Epi ordered but not given. Her symptoms improved after medication admin. Transferred to the floor for further eval. She has an extensive allergy history to azithromycin, morphine, peanuts, red dye, shellfish/seafood, oranges. She saw an allergist as a child but has not for some time. She has had similar reactions to this episode with exposures and usually take Benadryl/famotidine with resolution. Also has history of allergic rhinitis and chronic sinus issues. Patient's symptoms improved with overnight evaluation, although noted 2 episodes of emesis and EKG with sinus tachycardia. Patient stable with planned discharge with outpatient evaluation of sinus tachy. Per medical team this development is not likely related to acute event due to persistence.
31 2021-03-22 dry mouth Patient reported dizziness, dry mouth, and feeling flushed. Nurse observed the patients cheeks were... Read more
Patient reported dizziness, dry mouth, and feeling flushed. Nurse observed the patients cheeks were flushed.Oral mucosa moist. Captain obtained vital signs. Vitals within normal ranges. Patient asked to remain in the observation area for an additional 20 minutes. Patient offered transport to the hospital via ambulance. Patient refused. Patient advised to follow up with her provider if symptoms continue.
31 2021-03-24 blindness transient, thirst blackout episode (temporary loss of vision) while attempting to rise Extreme pain and feeling of pr... Read more
blackout episode (temporary loss of vision) while attempting to rise Extreme pain and feeling of pressure/bursting all over body; extreme sensitivity when any area of the body was touched (including scalp, legs, etc) Fatigue, weakness and inability to get out of bed or sit without aid for roughly 24 hours O2 dropped to 92 per pulse oximeter at home Swollen, painful lymph node under armpit 2 days after vaccine Gasping for breath (although no coughing or sneezing) Nausea Drinking a lot, extreme thirst but very little urination
31 2021-03-24 ear itchiness, oropharyngeal discomfort Right-sided eustachian tube itchiness, throat discomfort, rhinorrhea, and sneezing 6 hours post-vacc... Read more
Right-sided eustachian tube itchiness, throat discomfort, rhinorrhea, and sneezing 6 hours post-vaccine. I took one allergy pill which mildly resolved symptoms.
31 2021-03-24 lacrimation increased, eye itchiness Since the vaccine, I have experienced extreme paraesthesia throughout my left head and face. It is... Read more
Since the vaccine, I have experienced extreme paraesthesia throughout my left head and face. It is chronic and lasts from the moment I wake up to the moment I go to bed. I am also experiencing a watering, itchy left eye and tingling behind the eyeball. Extreme neuropathy in brain, it feels like electric shocks coursing through my head and crabs pinching at the brain tissue. I have also deal with temporarily facial paralysis on the left side of my face, though those symptoms have since abated. I am on Lyrica, prednisone, indomethacin, and xanax in an attempt to get some relief but there are very few doctors who seem to understand what is causing this debilitating adverse reaction.
31 2021-03-24 vision blurred Severe headaches with blurred vision and headaches for several days. No over the counter meds have h... Read more
Severe headaches with blurred vision and headaches for several days. No over the counter meds have helped
31 2021-03-25 hearing loss, tunnel vision Dizziness Tunnel visioning Hearing muffled Clammy
31 2021-03-25 mouth tingling, mouth numbness Client initially reported tingling/numbness in right ear. This progressed over next ten minutes to ... Read more
Client initially reported tingling/numbness in right ear. This progressed over next ten minutes to tingling/numbness across her face and the roof of her mouth, she also reported difficulty swallowing. Client observed to be flushing across face and upper arms. EMS called and transported client to local ER for evaluation.
31 2021-03-25 visual impairment I had a mild headache for about 6 days. On day 7, I had a temporary vision cut for 43 min and then i... Read more
I had a mild headache for about 6 days. On day 7, I had a temporary vision cut for 43 min and then it returned in full, but I had a severe migraine and nausea. They did CT imaging and labs. Everything was clear. I was medicated with IV pain meds and anti-nausea meds. I continued to have a mild headache for a few days, but it eventually resolved.
31 2021-03-26 taste impairment, mouth numbness Metallic taste in mouth and numbness of tongue - kind of like licking a battery. Started about 30 m... Read more
Metallic taste in mouth and numbness of tongue - kind of like licking a battery. Started about 30 minutes after vaccination. Has been coming in and out for about a week now. Currently very strong. Not worried about it, but thought it was worth reporting.
31 2021-03-26 ringing in ears Started developing a ringing & buzzing noise in my left ear like tinnitus. Noise/buzzing is nonstop.
31 2021-03-28 feeling of choking Tingling all over throat, face, arms legs, swollen throat, redness all over neck and chest
31 2021-03-28 vision blurred after 15 minutes post pfizer vaccine dose one, pt stated she felt dizzy and nauseaus, unable to stan... Read more
after 15 minutes post pfizer vaccine dose one, pt stated she felt dizzy and nauseaus, unable to stand, and stated her vision was blurry. PR 160/80, pulse 58. Cold compress given. pt stated symptoms were worsening and pt taken to the ER.
31 2021-03-30 lip swelling After getting the first dose and after three minutes I feel*dizziness and my heart rate is getting l... Read more
After getting the first dose and after three minutes I feel*dizziness and my heart rate is getting low and my ass reflux is coming up. I tried to drive home but I could not able to do it. My husband came in he picked me.On the facility they said my ass reflux is causing my all the problems I came home and take his reflux medicines and doing rest in 1 to 2 days I getting better. But after three days my face getting swell and my lips get swell my throat gets well from inside too. My body start eating and on the aging spot on my arm and knee I had patches. I went to my primary care and my primary care said to me I might have a COVID-19 Pfizer vaccination reaction because my routine remains same as before nothing anything new medicine added to my routine. My primary care give me prednisone and Zyrtec. After getting prednisone and after a week I feels better myself. I am not sure should I go for second doors or not please advise me if you can and and report my problem after vaccination thank you so much
31 2021-03-31 swollen tongue, mouth numbness Anaphylaxis; Swelling/tightness of the throat and chest; Swelling/tightness of the throat and chest;... Read more
Anaphylaxis; Swelling/tightness of the throat and chest; Swelling/tightness of the throat and chest; Swelling of the tongue; numbness of the tongue; persistent disorientation; confusion; Rapid heartbeat; This is a spontaneous report from a contactable consumer (patient herself). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via an unspecified route of administration in left arm on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) and asthma. The patient had no known medical allergens. Concomitant medications in two weeks included amoxicillin, clavulanic acid (AMOXCLAV 875-125 MG) and cetirizine hydrochloride (ZYRTEC 10 MG). The patient did not receive other vaccines in four weeks. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. On 17Mar2021 12:15 PM, the patient experienced anaphylaxis, swelling/tightness of the throat and chest, swelling of the tongue, numbness of the tongue, persistent disorientation and confusion, and rapid heartbeat. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment included 2 Epipens, Benadryl 25 mg, and intravenous Benadryl. Outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
31 2021-04-01 lip swelling, mouth tingling 103F fever lasting 72 hours, chills, vomiting, headache, muscle stiffness, facial numbness, lip ting... Read more
103F fever lasting 72 hours, chills, vomiting, headache, muscle stiffness, facial numbness, lip tingling, lip swelling. All symptoms lasted 72 hours with headache, brain fog, muscle stiffness still present at 72 hour mark
31 2021-04-02 eye strain, vision blurred Soon after receiving the vaccine, once I was seated for the observation period, I noticed my eyesigh... Read more
Soon after receiving the vaccine, once I was seated for the observation period, I noticed my eyesight was strained. It was hard to focus to see what was in front of me. At the time I was trying to watch a slideshow on the TV in the room with vaccine facts. This subsided, but came back the next day in the evening (around 5pm). I noticed this at 5pm while trying to work on my computer.
31 2021-04-02 vision blurred vertigo; dizziness; blurred vision; This is a follow up spontaneous report from a contactable consum... Read more
vertigo; dizziness; blurred vision; This is a follow up spontaneous report from a contactable consumer (Patient). A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 (Batch/Lot Number: EM9810) as single dose for covid-19 immunisation. Medical history included none. No concomitant drugs were reported. On 05Feb2021 16:35, The patient experienced vertigo, dizziness and blurred vision on unspecified time. Consumer says she just had her first dose of the Pfizer COVID-19 vaccine around 03:00-03:15PM today, and then about 20 minutes ago she had vertigo, or a dizzy spell then bad blurred vision. She says she feels normal or feels ok now, but it took like 5 minutes to get better, maybe 10-15 minutes. Consumer says she would like to know if this is normal, or if she should seek medical attention. she has had no recent vaccinations and is on two meds but they are not new, she has taken them 6 months already. The action taken in response to the events for BNT162B2 was not applicable. The outcome of event was recovered.
31 2021-04-04 vision blurred, visual impairment 2 Days after receiving my 2nd Pfizer shot, I began to have blurred vision in only my right eye. For... Read more
2 Days after receiving my 2nd Pfizer shot, I began to have blurred vision in only my right eye. For the first week, it began to get worse a little bit each day making it difficult for me to see out of my right eye. By the end of the first week (February 22 - February 28), my eye sight had gotten so blurred/darkened with my vision in my right eye that I was uncomfortable operating a vehicle. During the week of March 1 - March 7, I did not drive and went to the Eye Institute on March 1st assuming it was a retinal tear or something more serious due to the lack of vision in one eye. There was blurred vision with a darkness that covered the center part of my eyesight. It was very difficult to see if it was bright outside and there were little floaters here and there. I explained this to the urgent care doctor at Eye Institute and they completed retinal scans and various other tests/scans. The doctor did not see anything physically wrong with the eye. For that next week (March 1 - March 7), my vision continued to remain exactly the same where there was a large, dark spot constantly when I looked out of my right eye. As I stated above, it was also very sensitive to light. I went on Monday, March 8th to get a second opinion, but they also could not tell me what was wrong. Exactly 2 weeks after the vision issue started, my vision began to return normally. During the week of March 8th, my right eye regain its vision back to its normal eyesight. By the end of the week (March 13th-ish), I would say my vision was at least 75% back to normal. It is 100% back to normal now and has been for a few weeks now.
31 2021-04-05 pain in jaw, mouth tingling, swollen tongue, mouth numbness On day of vaccine -- Extreme dizziness began 1 minute after shot. Dizziness lessened to a tolerable... Read more
On day of vaccine -- Extreme dizziness began 1 minute after shot. Dizziness lessened to a tolerable level (I felt I could safely walk around) after about 5 minutes. Dizziness continued to come on sporadically when standing, though lessening in severity and frequency over time. As of today (4/6/21), the dizziness will still occur occasionally when standing or when moving from a sitting to a standing position. In addition, about 1 hour after the shot, pain began in my jaw and neck area on the left side. This lasted for about three hours. The pain then moved down in my shoulder around the injection site. The pain did not return to my jaw/neck region, and the pain in my shoulder went away after 3 days. 4/2/21 -- Facial and neck numbness began. The left part of my tongue, about one quarter of it, was numb. The left side of my face extending back to my ear and scalp, and down the left side of my neck was numb. 4/3/21 -- Numbness spread down my shoulder, arm, and into my fingers, but was less severe than the numbness in my face and neck. 4/4/21 -- Began 600mg of ibuprofen 3x/day. Numbness decreased after second dose, especially in tongue, but still present. Numbness increased when laying on left side. Weakness in left arm. 4/5/21 -- Increased weakness in left arm and fingers. Numbness still present, but lessened in face and neck. Minor facial swelling in left cheek, left side of tongue tingling and felt slightly swollen. Took 2 Benedryl, did not seem to make a difference. 4/6/21 -- Soreness where left leg connects to hip. Left leg feels a little shaky and weak. Continued symptoms from previous entries. A little brain fog, difficult to concentrate at times. Jaw felt swollen on both left and right side, noticeable when trying to open mouth. Decreased after ibuprofen. Feelings of weakness and general "off" feeling worse when standing versus laying down.
31 2021-04-06 eye strain Loss of balance 6:50a when heading to the shower. Sat down on the toilet, room spinning. Laid back i... Read more
Loss of balance 6:50a when heading to the shower. Sat down on the toilet, room spinning. Laid back in bed and everything still spinning. The worst of it lasted about 30-45min. Currently laying in bed and eyes are heavy. Have a headache and fatigued. Dizziness comes and goes but not nearly as bad as this morning. It is currently 10:19am.
31 2021-04-06 mouth numbness On Sunday, April 4, 2021, I began to experience a numbness of my tongue. Hours later, I began to ha... Read more
On Sunday, April 4, 2021, I began to experience a numbness of my tongue. Hours later, I began to have tingling in the left side of my face. By Monday, April 5, 2021, I began to experience a slur in my speech along with the aforementioned symptoms from the day before. By Tuesday, April 6, 2021, I experienced what feels like a facial paralysis on the left side of my face. This includes not being able to smile, blink, shut my eye, or raise my eyebrow on the left side of my face.
31 2021-04-06 bloodshot eyes Day 1- soreness in arm Day 2- super sore and stiff Day 3- slightly sore Day 4 at 830pm- bloodshot ey... Read more
Day 1- soreness in arm Day 2- super sore and stiff Day 3- slightly sore Day 4 at 830pm- bloodshot eyes, burning sensation throughout my whole body. My feet felt like they were on fire. I felt discombobulated, cloudy and weak. I went to the ER, that will be listed in ite. 19. Day 5- super weak and still out of it but the burning sensation is gone.
31 2021-04-07 taste impairment My mouth taste like I just ate cleaning solution disgusting taste.
31 2021-04-07 mouth tingling "fuzzy" tongue, funny feeling in throat, whelts on neck
31 2021-04-07 swollen tongue, mouth tingling, mouth numbness Patient developed lip tingling, tongue numbness and swelling, throat swelling. EMS was contacted. ... Read more
Patient developed lip tingling, tongue numbness and swelling, throat swelling. EMS was contacted. Patient chewed 50mg Benadryl and was given 3 doses of Epinephrine before EMS arrived. Patient was stable when transported to ER.
31 2021-04-08 ear discomfort Starting 24 hours after vaccination: abdominal pain. Pulling, aching burning sensation. Starting 52... Read more
Starting 24 hours after vaccination: abdominal pain. Pulling, aching burning sensation. Starting 52 hours after inoculation Temporary paralysis in arms and legs and rapid pulse for 1 hour followed by numbness and tingling in hands and feet. Hands and feet felt like ice cubes and could not get warm. Weakness in legs continued. Total experience lasted 10 hours. CT scan and blood work done. CT scan showed new incidence of splenomegaly and decreased RBCs. Hospitalization via ambulance for 4.5 hours. Discharged with follow up CT in 6 months. 72 hours after vaccine the tingling continues in feet. Pressure in bilateral ears. Continuing abdominal pain.
31 2021-04-08 toothache, teeth hypersensitivity Lethargy Headache Brain fog Little bit of Nausea but not bad Soreness at injection site But the wei... Read more
Lethargy Headache Brain fog Little bit of Nausea but not bad Soreness at injection site But the weirdest side effect was this strange toothache - front teeth and gums, down to the bone, top and bottom rows, felt like sinusitis toothache (except bottom teeth were also aching) - but also as if I?d over-bleached them. Very sensitive to pressure/hot/cold. For reference I did not bleach my teeth and have no sinus issues currently. Sensation was gone by the next morning. Currently (4/9 9:29pm) no side effects to report except a little lingering arm soreness. All good :)
31 2021-04-09 taste impairment Metal taste after vaccine;Headache and chills, fogginess
31 2021-04-09 ear pain, eye pain, vision blurred Had swollen lymph node under left armpiot (1st dose) for 3-4 weeks. Had a small swollen lymph node o... Read more
Had swollen lymph node under left armpiot (1st dose) for 3-4 weeks. Had a small swollen lymph node on right armpit after second dose. About 10 days after second vaccine, I had an ear ache. The next day the left side of my neck was swollen and the left side of my forehead and eye tingled and hurt. I took ibuprofen for 2 days and the lymph nodes started swelling. The 3rd day I woke up with rashes. I went to the doctor and I had shingles in eye. I had blurry vision by the time I got the doctor.
31 2021-04-09 toothache Face periodically felt hot/numb for 2 hours. Around 4pm top front teeth hurt like they do during a s... Read more
Face periodically felt hot/numb for 2 hours. Around 4pm top front teeth hurt like they do during a sinus infection. This lasted for 6 hours. At 10am following day suddenly felt fatigued/dizzy. Vomited at 11am. By 6pm felt fatigued but was able to eat/drink like normal.
31 2021-04-11 eye irritation Difficulty breathing, chills, cold sweat, hives, swelling of face, severe headache, sensitive skin, ... Read more
Difficulty breathing, chills, cold sweat, hives, swelling of face, severe headache, sensitive skin, eyes burning. Lasting a week. Swelling still occurring in face.
31 2021-04-12 lip redness, mouth ulceration, lip swelling Whole body pink macules, entire chest, back, legs, upper lower, and upper arms are confluent, entire... Read more
Whole body pink macules, entire chest, back, legs, upper lower, and upper arms are confluent, entirely covered, slightly elevated. Lips are red, mildly swollen. 1 oral ulcer. Given 125mg of Solu-Medrol and Prednisone course.
31 2021-04-12 oropharyngeal discomfort "raspy feeling ,something stuck in throat"
31 2021-04-12 tunnel vision Within five minutes was feeling dizzy, hot, vision started to tunnel. Suddenly broke into a sweat an... Read more
Within five minutes was feeling dizzy, hot, vision started to tunnel. Suddenly broke into a sweat and then lost consciousness in a seated position. Nurses came over, laid me on my side, took blood pressure and pulse, and loosened flannel shirt/jacket. After about 10 minutes started to regain mental clarity. After 30 minutes was driven home by husband.
31 2021-04-12 visual impairment, taste disorder fainted; having an odd taste in my mouth; shortness of breath/breathing took 40 minutes to return to... Read more
fainted; having an odd taste in my mouth; shortness of breath/breathing took 40 minutes to return to normal; vasovagal syncope response; the expected sore injection site; headache; felt overheated; could quite literally only see stars; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 04Apr2021 10:45 (Lot Number: ER8732) as single dose for covid-19 immunisation. Medical history included hypoglycaemia (she ate before the injection) and fainting. Concomitant medication(s) included Birth control and prednisolone acetate ophthalmic sus. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. 5 minutes after the injection, the patient began having an odd taste in mouth, shortness of breath, and she fainted. She had a history of fainting, but it took longer for her to recover than usual (50 minutes instead of 15). When she regained consciousness a few minutes after, she had a headache, felt overheated, and could quite literally only see stars. Her breathing took 40 minutes to return to normal, and her body temperature took 2 hours to feel normal. She assumed this was mostly a vasovagal syncope response, but she wasn't anxious or in pain beforehand. After 6 hours, she still have the odd taste, a headache, and the expected sore injection site. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events included Paramedic took vitals and monitored for an hour. The outcome of the events was recovered with sequelae. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
31 2021-04-13 eye twitching, ear infection I received the first Pfizer vaccine on 3/16/21 in the afternoon. I am a young, healthy woman with no... Read more
I received the first Pfizer vaccine on 3/16/21 in the afternoon. I am a young, healthy woman with no pre-existing health conditions: I don't smoke, am under 120 lbs., no allergies, etc. Two days after the vaccine, I started to experience an eye twitch, which progressed into Bells Palsy by the following week: by 3/23/2021. I went to an urgent care clinic and was diagnosed as such, and they contributed to the vaccine and told me not to get the second shot. They also advised I get a CT scan to rule out a stroke, which I did, on 3/24/21. I expect that they also reported this. I have facial paralysis on the left side of my face, and developed an ear infection a week after this...I don't have allergy issues, and have not had an ear infection since I was a small child. This has been traumatic, uncomfortable and very scary because I thought I was having a stroke.
31 2021-04-13 mouth numbness, vision blurred PATIENT STARTED TO FEEL NUMBNESS IN TOUNGE AND FACE. PATIENT STATED BLURRY VISION WHEN LOOKING AT L... Read more
PATIENT STARTED TO FEEL NUMBNESS IN TOUNGE AND FACE. PATIENT STATED BLURRY VISION WHEN LOOKING AT LIGHTS. PATIENT WAS GIVEN BENADRYL WATER AND PREZTELS. PATIENT STARTED TO FEEL BETTER BUT THEN STARTED TO FEEL NUMBNESS/TINGLING IN LEFT SIDE OF FACE, LEFT FOOT, AND LEFT LEG. PATIENT WAS TAKEN TO EMERGENCY ROOM AFTER SPEAKING WITH HER PRIMARY CARE DOCTOR.
31 2021-04-13 swelling of eyelid I developed blepharitis of my left upper eyelid with tenderness and swelling. Symptom onset 8-10 hou... Read more
I developed blepharitis of my left upper eyelid with tenderness and swelling. Symptom onset 8-10 hours afterward, peaked 48 hours later. This eventually led to 2 chalazions in that eyelid. I have never had one before in my life. I may have been predisposed somehow and the inflammatory response to the vaccine triggered the blepharitis. I looked like cartoon character. The blepharitis was gone within 10 days but despite intervention, the chalazions did not clear up. (I'd prefer to call this a side effect rather than an adverse effect, but I'm filling this out to provide more complete data as I know several people who have had inflammatory problems with the vaccine.)
31 2021-04-13 vision blurred, visual impairment I experienced stroke like symptoms on Saturday, April 10th, 15 days after receiving my first dose of... Read more
I experienced stroke like symptoms on Saturday, April 10th, 15 days after receiving my first dose of the Pfizer vaccine. I experienced these symptoms starting around 1:30pm. First, my eyesight had been affected, I was seeing a black straight line aura in both of my eyes, I could not focus on any objects or people. I walked around my house and splashed some water on my face because I was feeling faint, I walked into the kitchen and said I?m going to pass out, I need to sit down, I sat on the floor... my partner was cooking me food and I asked him to get me water, but what came out was ?get me watermelon? from that point on, several of my sentences were not making sense and I was experiencing aphasia. I was starting to freak out and my right thumb began to tingle and feel numb. My partner gave me .05 mg of Xanax because I was shaking uncontrollably. I became very cold. It took about 20-25 minutes to calm down. In that time, I tried to read words off of his phone and I could not verbalize out loud what specific words actually said, it made sense in my mind, but when I would try to read it out loud, it was wrong. My episode ended in about 25 minutes, while I was eating and then I went to the urgent care.
31 2021-04-14 taste impairment Patient experienced a metallic taste in her mouth approximately 15 minutes after receiving vaccine. ... Read more
Patient experienced a metallic taste in her mouth approximately 15 minutes after receiving vaccine. She was to then be observed longer. Vitals at 4:10pm= BP 142/90mmHg, PO2 96%, and heart rate 88 beats/min. Patient reports she had already been having an asthma exacerbation earlier during the day and walking into the facility from the cold makes her asthma worse. Upon the metallic taste in her mouth and the need to be observed longer she states she had some anxiety and that this contributed to her wheezing. Patient took one puff of her albuterol inhaler and was feeling better. At 4:25pm the nurse noted lungs were clear with no wheezing detected. After approximately 30-45 minutes of observation, she was then walked by a nurse outside and due to the cold bothering her lungs she took a second puff of her inhaler in her car. Her wheezing lessened and the patient felt fine to go home.
31 2021-04-14 lip swelling Swelling of the lips. Has had lip fillers 1 year and 4 months prior
31 2021-04-15 loss of taste, vision blurred, loss of smell Coughing, fatigue, shortness of breath, dizzy, sore arm, next day had no taste, fever, chills, hot f... Read more
Coughing, fatigue, shortness of breath, dizzy, sore arm, next day had no taste, fever, chills, hot flashes, blurry vision
31 2021-04-15 mouth tingling Almost immediately began to experience lightheadedness, racing heart, and throat tightening. Informe... Read more
Almost immediately began to experience lightheadedness, racing heart, and throat tightening. Informed nurse. Was told to sit on ground and was given liquid Benedryl. Was told to lie down with legs propped up on chair while ice pack was put under my neck. Throat continued to tighten. Gave permission for epi pen, which was administered. Laid back down for a few minutes and tightening did not seem to worsen. After a few minutes I sat back up and was told to sip a few sips of water. After the third sip, my throat began to tighten, laid back down which did not help. Technicians called an ambulance and administered a second epi pen with my permission. EMTs arrived and took me to their rig. My vitals were fairly steady but my lips and tongue had started to tingle and my throat was still tight. EMTs took me to Emergency Room. Was given steroids, pepcid, and benedryl. While throat was still tighter than normal, my stats were good, so I was discharged between 5-6, with perscriptions for prednesone, benedryl, pepcid, and 2 epi pens. At approximately midnight, began to feel throat tighten up again, took benedryl at 1:00, when condition did not improve, went back to ER approx, 2:20 am. Around 7-8 am was given steroids and benedryl, however my body began to react to the steroids with full body sensation of tingling/feeling as though it was going to sleep. Was given an ativan which calmed system down and allowed me to sleep. Eventually discharged around 11 am, told not to use steroids but to continue benedryl as needed.
31 2021-04-15 vision blurred 1511 Pt c/o feeling like going to pass out, lightheaded, diaphoretic. C/O right eye being blurry vi... Read more
1511 Pt c/o feeling like going to pass out, lightheaded, diaphoretic. C/O right eye being blurry vision. OxSat 97%, HR 92, RR 14 easy and un-labored. States this always happens "when I get a flu shot" Oriented x 4. 1515 OxSat 97%, HR 94, Blood sugar 110, Firefighter continued to monitor patient. @1524 states feels a litter better. Right eye is clearing up. States she is diagnosed with syncope. States had tilt table test alone. Continued to monitor pt. Pt states takes 15 mg Clonazepam for anxiety. Pt states mom died one month ago of COVID. @1545 pt states feels better, right eye is no longer blurry. @1557 pt states ready to go home. States does not need anyone to pick her up and she can drive home. RN walked with patient to exit door. RN stated pt had no complaints/issues.
31 2021-04-16 sensitivity to light, extreme sound sensitivity Dull Headache 4/14/21 at 6pm, Headache 4/15/21 at 9:30am, Migraine 4/15/21 at 11:30pm, Migraine 4/16... Read more
Dull Headache 4/14/21 at 6pm, Headache 4/15/21 at 9:30am, Migraine 4/15/21 at 11:30pm, Migraine 4/16/21 All Day - All were given 2 Tylenol at 500 mg to equal 1000 at approved intervals between 5-6 hrs apart. Migraines had light and sound sensitivity. Vertigo 4/16/21 All Day - No treatment provided other than resting with assistance to and from bathroom. Low grade fever of 99.9 4/15/21 and 4/16/21 - treatment was used the Tylenol used for the migraines, ice packs on forehead, cool showers and eating pop sickles. Lump on injection site 4/15/21, 4/16/21 and 4/17/21 - ice packs applied onto injection site to help with pain.
31 2021-04-17 ringing in ears I woke up to a loud ringing in right ear.
31 2021-04-17 visual impairment Patient received the 1st COVID vaccine Pfizer lot # EW0162 and expiration date 04/16/2021 at 5:22 pm... Read more
Patient received the 1st COVID vaccine Pfizer lot # EW0162 and expiration date 04/16/2021 at 5:22 pm. Client reported to EMT. EMT and RN responded. Client laying in recliner chair in semi-followers position. Client reports "I felt light headed and sweaty" for about one minute following administration of Pfizer vaccine to right arm. The client reports "I saw black and white specs for a few seconds". Client reports history of similar incidents when client is near "blood and needles". No medical history, medication or allergies per client. Client denied feeling dizziness, light headedness, shortness of breath, facial or throat swelling, palpitations, chest pain or other symptoms at the time of report. Client was placed in semi-fowlers position and given water. Client is a/oX3. Vital Signs at 11:43am BP 100/70, HR: 76, RR:18. Client advised to be observed for additional 30 minutes. VS at 12:05pm BP 122/92, HR 70, RR 18 while semi-fowlers. VS at 12:18pm BP 114/86, HR 68, RR 18 while sitting-feet on floor. VS at 12:27pm BP 122/90, HR:70, RR 18 while standing. ER precautions given. Client informed to f/u with PCP. Recommendation given to client for transportation after vaccination incident. Client verbalized understanding. Client given instructions to bring driver for next appt and to inform vaccinator of this event. Client verbalized understanding. Per client, symptoms resolved 1 minutes after onset of symptoms onset. Client walked out of site with a steady gate.
31 2021-04-18 blindness Three days after I got the vaccine, I noticed a very abnormal heart palpitation lasting about 3 seco... Read more
Three days after I got the vaccine, I noticed a very abnormal heart palpitation lasting about 3 seconds. Everything felt fine so I sat down for a few minutes. Once I got up I came very close to passing out. I lost my balance and my vision was dark. Never experienced anything like this before
31 2021-04-18 visual impairment Patient with light headed feeling, heart palpitations, Feels dazed and syncopal. Stated visual defe... Read more
Patient with light headed feeling, heart palpitations, Feels dazed and syncopal. Stated visual defect present. VS stable. EMS called for consultation. Evaluated. Orange juice given and pretzels. Released to family after refusing transport to local healthcare facility. Patient will eat before dose 2 in 21 days.
31 2021-04-18 visual impairment Worst headache of my life impairing my vision and all daily activities. Lasted for 3 days after shot... Read more
Worst headache of my life impairing my vision and all daily activities. Lasted for 3 days after shot. Extreme fatigue, diarrhea, injection site pain, nausea lasting 3-5 days after shot. Dizziness and off balance causing me to fall over on day 5. Lasted through the day and into the next Elbow pain still (going into one week after shot) and injection arm feels tingly Took extra strength Tylenol and it seemed to help, but not fully take symptoms away
31 2021-04-19 taste impairment Sore arm and headache for 2 days Metallic taste in mouth for at least 3 days (not yet resolved)
31 2021-04-19 eye irritation This is a healthy 31 year old g3p2 at 15 weeks 5 days by 1st tri u/s. Uncomplicated pregnancy, hx 2... Read more
This is a healthy 31 year old g3p2 at 15 weeks 5 days by 1st tri u/s. Uncomplicated pregnancy, hx 2 prior vaginal deliveries. Healthy babies, 7 and 8#. Has hx PCOS and takes metformin, no other medical problems. Patient had a covid vaccine and developed a herpes zoster eruption 48 hours later. She has classic zoster eruption on her right flank. There is a cluster of bright red vesicles in a dermatomal distribution on her right flank. She had classic prodromal sx with itching and burning in the area for a few hours before the rash was visible.
31 2021-04-19 sensitivity to light 40 hours after vaccination severe light sensitivity causing paralysis and fainting in daylight.
31 2021-04-20 dry mouth Pt c/o DOB, SOB, dry mouth
31 2021-04-20 taste impairment metallic taste in the mouth, arm soreness, redness around the injection site, swelling
31 2021-04-20 eye pain I received my 1st dose vaccine on Sunday, April 18th at 12:00pm. I started to show some uncomfortabl... Read more
I received my 1st dose vaccine on Sunday, April 18th at 12:00pm. I started to show some uncomfortable symptoms on Tuesday, April 20th around mid-morning. It started with a bad headache and tiredness. By the evening on 4/20/2021 my eyes were sore, my head was pounding, I was extremely tired - just all around feeling unwell. Slept all night. Woke up this morning (4/21/2021) with a continued headache, sore eyes and feeling dizzy and very tired. This is still happening as I fill this form out (10:10am / 4/21/2021)
31 2021-04-20 sensitivity to light, eye pain Fever, chills, nausea, headache, extreme body aches/pain on Saturday. Fever, chills, headache, extre... Read more
Fever, chills, nausea, headache, extreme body aches/pain on Saturday. Fever, chills, headache, extreme body aches/pain on Sunday & Monday. Less chills, extreme headaches, slight pain behind eyes, sore throat, congestion and cough on Tuesday. Headaches, congestion, cough, extreme pain behind eyes when looking left/right up/down, sensitive to bright lights today (Wednesday).
31 2021-04-20 vision blurred Client (DOB:3/13/1990) received the 1st dose of Pfizer COVID vaccine lot #EW0171 and expiration date... Read more
Client (DOB:3/13/1990) received the 1st dose of Pfizer COVID vaccine lot #EW0171 and expiration date 4/24/21 at around 4pm. Client reported to vaccinator that she couldn't see for a few seconds right after injection. Vaccinator walked client over to observation area where PHN arrived to find client sitting upright alert and oriented x4 in a chair. Client reports she had blurred vision right after injection. At 4:03pm vitals were taken: blood pressure: 133/93, pulse: 88 and oxygen: 98%. Client reports blurred vision is completely resolved. Client has no medical history and only takes vitamins. Client did report she gets headaches and has been seen by doctors for them. Client reports she has been very stressed lately and has been running around all day. At 4:10PM vitals were taken: blood pressure: 134/93, pulse: 88 and oxygen: 98%. Client reports she has not eaten since 9 or 10 am. PHN offered water. At 4:15PM vitals were taken: blood pressure: 142/87, pulse:79 and oxygen: 98%. At 4:25PM vitals were taken: blood pressure: 126/89, pulse:78 and oxygen: 98%. PHN advised client to speak to her provider about her blurred vision and ER precautions. At 4:33pm client left facility with a steady gait.
31 2021-04-20 visual impairment Headache, nausea, fever, dizzy, body aches, chills Next day - crossed vision, couldn't walk straigh... Read more
Headache, nausea, fever, dizzy, body aches, chills Next day - crossed vision, couldn't walk straight - went to urgent care, sent to ER
31 2021-04-21 lip swelling Migraine Swelling in the lips Body pain Loss of appetite
31 2021-04-21 swollen tongue I'm 32 weeks pregnant. Due date june 17, 2021. Received first dose at 1015am and within two hours ha... Read more
I'm 32 weeks pregnant. Due date june 17, 2021. Received first dose at 1015am and within two hours had a swollen tongue with white patches and bumps similar to thrush. Tongue was fine prior to vaccine. When trying to look up if it's common I saw pictures of what some call COVID tongue and it's does look similar to that.
31 2021-04-22 loss of smell None stated.
31 2021-04-22 taste impairment Chills Body aches Headache Runny nose Metallic taste in mouth Fatigue
31 2021-04-22 mouth numbness Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mil... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported feeling numbness spread over the left side of her face and the back of the head. After waiting 45 minutes, patient reported feeling tingling in the left side of the face.
31 2021-04-22 ringing in ears, ear discomfort Ringing in both ears. Stuffiness in ear and inner ear pain. Been trying to take supplements zinc, NA... Read more
Ringing in both ears. Stuffiness in ear and inner ear pain. Been trying to take supplements zinc, NAC, ginkgo biloba, multi vitamins and Claritin. Ringing still persisting after 11 days
31 2021-04-23 loss of taste, ear pain, loss of smell I had a low grade fever, chills, aches, sore throat, ear ache, cough that lasted a week. Loss of sme... Read more
I had a low grade fever, chills, aches, sore throat, ear ache, cough that lasted a week. Loss of smell and taste for 2 days.
31 2021-04-23 taste impairment Delayed COVID vaccine arm (swelling, pain, itchinnes, inflammation, warm to the touch at the site of... Read more
Delayed COVID vaccine arm (swelling, pain, itchinnes, inflammation, warm to the touch at the site of the injection), extreme fatigue and sleeplessness. I also had metallic taste in my mouth (which I reported separately), which I got about 10 mins after the vaccine and it lasted for about 36 hours.
31 2021-04-24 loss of smell, loss of taste Long-lasting headache within 30-minutes after receiving vaccine. Low-grade fever and fatigue the nig... Read more
Long-lasting headache within 30-minutes after receiving vaccine. Low-grade fever and fatigue the night of the vaccine. Loss of taste and smell the morning after. Lasted about an hour or so.
31 2021-04-24 tongue itchiness Itchy throat, tongue and cough. Generalized itching. Benadryl 50mg and solumedrol administered. Pt. ... Read more
Itchy throat, tongue and cough. Generalized itching. Benadryl 50mg and solumedrol administered. Pt. kept for >1hr for observation. Released to home in no distress. Pt. instructed to go to ER is becomes symptomatic.
31 2021-04-24 vision blurred Blurry vision and tight neck muscles on right side
31 2021-04-25 eye pain, burning mouth syndrome, taste impairment Symptoms that started within 2 minutes of receiving the vaccine, but cleared up in about 1 hour incl... Read more
Symptoms that started within 2 minutes of receiving the vaccine, but cleared up in about 1 hour included: (1) Soreness in the tongue and a sensation that felt like I could taste the vaccine, (2) pressure behind the eyes, (3) chest tightening, (4) need to concentrate on breathing, (5) burning sensation (felt similar to the sensation when getting a CT scan), (6) sensation of something washing over entire body, and (7) sharp pain in right calf. Symptoms that started within 5 minutes of receiving the vaccine and lasted for 36 to 72 hours included: (1) nausea (~36 hours), (2) headache (~36 hours), and (3) pain at the injection site (~72 hours). No treatment for any symptoms. All cleared up on their own in the timeframe indicated.
31 2021-04-25 mouth ulceration Caller stated that she received her second Pfizer vaccine on 04/19/2021 and on the sameday she devel... Read more
Caller stated that she received her second Pfizer vaccine on 04/19/2021 and on the sameday she developed fever, the second day she developed migraine headache to the left of her head and on the third day she developed mouth sores.
31 2021-04-26 permanent deafness, ringing in ears, sudden hearing loss, ear discomfort Two weeks after the first dose I suddenly experienced sudden tinnitus, ear fullness, and vertigo. I ... Read more
Two weeks after the first dose I suddenly experienced sudden tinnitus, ear fullness, and vertigo. I sough medical care the next day and was told I had allergies, after two days I went to an ENT and was given audiometry testing and it was discovered I was experiencing sudden hearing loss. I was put on a high dose of prednisone for 12 days, had a intratympanic injection of dexamethasone to try and regain the lost hearing and help with the tinnitus and none of the treatments worked. Now almost two months after the event I am still experiencing tinnitus and was diagnosed with sudden idiopathic sensorineural hearing loss and tinnitus. I did not think to attribute it to the vaccine but saw some other reporting a similar experience and wanted to report just in case this is a side effect that can be researched and even fixed in the future.
31 2021-04-26 ear discomfort Pt began with hot ears, itching on trunk within 15 min after receiving vaccine. States this happens... Read more
Pt began with hot ears, itching on trunk within 15 min after receiving vaccine. States this happens with a lot of medications Symptoms progressed resulting in transport to ED
31 2021-04-26 thirst 3 days after injection shoulder blade pain started, intense muscle aches in back with headache. Day ... Read more
3 days after injection shoulder blade pain started, intense muscle aches in back with headache. Day 4 (Saturday) throat hurting - 10pm red spot noticed on back of throat Day 5 still throat pain, fatigue as expected saw doctor said it was reaction to vaccine Day 6 still uncomfortable- start throwing up at 6 pm Day 7 post shot extreme fatigue, arms and legs felt on fire, slept all day, chills after eating, blood pressure 174-109 and brought to the ER. Tested negative for COVID and labs came back normal Day 8 slept the entire day Day 9 uncomfortable but felt more alert - no appetite Muscle aches and pain persist - stomach pain right side begins and intense cramping right side of body Frequent bowel movement and abominable discomfort Excessive thirst Chest pain 21 days post vaccination with still muscle weakness, feeling of being lightheaded, fatigue, and stomach discomfort
31 2021-04-27 taste impairment Immediate rash on hands, spread to arms and metallic taste in tongue and tingling.
31 2021-04-28 loss of taste Chills, fever, body aches, loss of taste, sweats
31 2021-04-28 eye discomfort Pressure under the left eye, headache (day 1) diarrhea/loose stoole daily for 2 weeks
31 2021-04-29 pain in jaw Fatigue, chest heaviness, chest tightness, chest pain, arm discomfort, arm numbness, tingling arm, j... Read more
Fatigue, chest heaviness, chest tightness, chest pain, arm discomfort, arm numbness, tingling arm, jaw pain, shoulder blade discomfort
31 2021-04-29 mouth tingling, feeling of choking Patient left facility and returned after having left with complaints of tingling of mouth/throat. Pa... Read more
Patient left facility and returned after having left with complaints of tingling of mouth/throat. Patient developed cough and stridor. Epinephrine was administered and patient was transferred via EMS to ER
31 2021-04-29 ringing in ears Soreness of Body, Mild headache, Stomach cramps, Light headedness, Fatigue Tinnitus on left ear Too... Read more
Soreness of Body, Mild headache, Stomach cramps, Light headedness, Fatigue Tinnitus on left ear Took Tylenol once on 4/26nd once 4/27
31 2021-04-30 ear pain Fever; Extreme body aches; headache; lethargy; earache; This is a spontaneous report from a contacta... Read more
Fever; Extreme body aches; headache; lethargy; earache; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received second dose of BNT162B2 (BNT162B2; Lot number and expiry date not available), via an unspecified route of administration, in left arm on 08Apr2021 at 18:00 (at the age of 31-year-old) as a single dose for COVID-19 immunization. Medical history included sickle cell trait. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Lot number and expiry date not reported), via an unspecified route of administration, in left arm on 18Mar2021 at 18:00 as a single dose for COVID-19 immunization. The patient had no known allergies. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced fever, extreme body aches, headache, lethargy and earache on 09Apr2021. The events were reported as non-serious. The patient underwent lab tests and procedures which included nasal swab test: unknown results. The outcome of the events was unknown. No follow-up attempts are needed. Information about lot/batch number can be obtained.
31 2021-05-01 lip swelling Patient developed anaphylaxis 2 hours after receiving Pfizer shot. She had swollen lips and her thr... Read more
Patient developed anaphylaxis 2 hours after receiving Pfizer shot. She had swollen lips and her throat began to swell. She took a 25mg Benadryl 2.5 hours after the shot and is continuing to monitor to see if she needs to seek medical attention.
31 2021-05-02 ear pain Headache, body aches, ear ache, fatigue, nausea, sore left arm near injection site
31 2021-05-02 eye pain, ear pain 3:55 pm received injection and felt fine during 15 min monitoring period late evening beginning to e... Read more
3:55 pm received injection and felt fine during 15 min monitoring period late evening beginning to experience headache middle of the night (approximately 4 am) woke up with severe bodyaches morning (8 am) woke up with extreme acute stabbing pain in ears - stabbing pain persisting all day, extreme headache and pain behind eyes, body aches, chills, spinal pain from lower back up through neck all day (spinal column feels stiff and swollen) nausea began in morning and remained low to moderate but i have been in bed all day (increases upon standing up). 2pm tingling and numbness in right arm for approximately 30 minutes (not arm where i was injected!)
31 2021-05-02 mouth numbness, taste impairment, oropharyngeal discomfort, mouth tingling, mouth itchiness Tingling and numb tongue, itchy and warm soft palate, metallic taste, raw throat appeared about 1-2... Read more
Tingling and numb tongue, itchy and warm soft palate, metallic taste, raw throat appeared about 1-2 hours after vaccination. Nausea appeared 30 minutes after vaccination.
31 2021-05-02 lip pain, swollen lips, lip swelling Lips are puffy. little bumps along the outline of my lip. tingling sensation, extremely painful. The... Read more
Lips are puffy. little bumps along the outline of my lip. tingling sensation, extremely painful. They feel very raw and itchy, mostly around the outer edge. Hard to move them to be able to drink or eat. I have yet to get treatment other than using blistex to reduce the pain.
31 2021-05-02 mouth tingling Lips tingling and L arm tingling/numbness 10-15 min after 1st dose on same size injection was admini... Read more
Lips tingling and L arm tingling/numbness 10-15 min after 1st dose on same size injection was administered. Symptoms lasted for 8 hours post-vaccination and resolved w/out medical treatment.
31 2021-05-03 taste impairment, eye pain After the first day of receiving the shot by morning I had a strong metallic "taste" in my mouth. Ev... Read more
After the first day of receiving the shot by morning I had a strong metallic "taste" in my mouth. Everyday since it has been stronger and weaker but not gone away completely. It's been a week now since the shot. I received the first dose on 4/27/2021 and today is 5/4/2021 7:24 PM. As of about 5:20 AM when I woke up on 4/28/2021 I noticed the taste. I also had a pain above my right eye when I was sleeping for a brief moment not sure what time. I am not sure it is caused by my sinuses but brushing my teeth, using saline solution in my nose, nasal spray hasn't changed anything. Everything I eat tastes gross and drinking water helps but does not get rid of the metallic "taste". If I plug my nose the metallic "taste" goes away completely in my mouth.
31 2021-05-04 dry mouth Patient started feeling like she had cotton mouth and felt very nauseous, so we gave her water. She ... Read more
Patient started feeling like she had cotton mouth and felt very nauseous, so we gave her water. She then felt like her throat was getting tight so we administered 25mg diphenhydramine, followed by a second 25mg diphenhydramine capsule a few minutes later. At this point the patient started getting hives on the back of her neck. We gave her an ice pack and called 911. The paramedics assessed her at this point and determined she did not need to go to the hospital. They advised the gentleman with her to keep an eye on her and to immediately go to the ER or call 911 if her symptoms worsened at all.
31 2021-05-04 eye pain Fever for 24 hours followed by migraine-like headache and eye pain that has lasted through 5/5/21
31 2021-05-04 bloodshot eyes, dry throat Patient received first dose of COVID-19 vaccine on 5/3/21 at 0733, patient was in observation area w... Read more
Patient received first dose of COVID-19 vaccine on 5/3/21 at 0733, patient was in observation area when she reported to RN that she feels her throat getting itchy and dry. Per RN, patient kept clearing throat and had edema and redness of the eyes. RN called RRT and administered 0.3 mg of Epi-Pen at 0749 in the meantime.
31 2021-05-04 visual impairment, vision blurred At the exact moment of injection , complete arm tense. After standing immediately on 1st injection I... Read more
At the exact moment of injection , complete arm tense. After standing immediately on 1st injection I experienced dizziness. During my ?observation? 15 minutes I was walking around the store with blurry and spotty vision. I almost felt like I was going to fall over, and had the feeling immediately that I needed to go to sleep. After eating ( this was at 9 in the morning after a full night of good sleep) I felt as if I needed to go to sleep immediately. I continued to sleep for two hours after the first dose. My menstrual cycle was delayed this month as well by 7 days and very heavy. The second dose was very similar. I have to say the pharmacy was excellent as I told them my experience with the first dose. I sat for 15 mins to make sure I wasn?t going to fall. I sat but still felt dizzy and saw spots with blurry vision. Same reaction. I went to sleep without hesitation like there was not a force in the world that could stop me. I have continued on both occasions to feel the effects around 24-48 hours after.
31 2021-05-05 eye swelling Happened after 10 min since first COVID shot.. Swollen eyes, difficult breathing, coughing, sweating... Read more
Happened after 10 min since first COVID shot.. Swollen eyes, difficult breathing, coughing, sweating. injected epipen right away prior to ER visit.
31 2021-05-05 swollen tongue Fever, aches, hives, swollen throat and tongue. Hydroxyzine HCL 10 mg (not incredibly effective), be... Read more
Fever, aches, hives, swollen throat and tongue. Hydroxyzine HCL 10 mg (not incredibly effective), benadryl, Tylenol Next day, still swollen throat and tongue but no hives, fever, or aches
31 2021-05-07 mouth numbness, teeth hypersensitivity, loss of taste Left part of face and left arm at sight of injection went numb and tingly after 25 minutes of receiv... Read more
Left part of face and left arm at sight of injection went numb and tingly after 25 minutes of receiving 2nd dose. Blood pressure and heart rate all fine during this time. Tastebuds / under tongue area went numb and had no taste. Bottom teeth very sensitive to cold. This all lasted for 24 hours, before going away. After 12 hours of getting the shot, I also had fever like symptoms that lasted for 12 hours.
31 2021-05-07 ringing in ears Tinnitus and extreme fatigue/fever/body aches. Vertigo immediately after shot
31 2021-05-08 taste impairment, loss of taste High Fever reached 103.4, chills, headache, body ache, nausea, dry cough, loss of taste, feel of bit... Read more
High Fever reached 103.4, chills, headache, body ache, nausea, dry cough, loss of taste, feel of bitter taste.
31 2021-05-08 eye swelling Swollen eyes, swollen lymph node in neck
31 2021-05-08 sensitivity to light The morning after my shot I had a fever of 102. Muscle pains, headache, sensitivity to light, vomiti... Read more
The morning after my shot I had a fever of 102. Muscle pains, headache, sensitivity to light, vomiting. I did not have a bowel movement for the entire day of the 8th of may. Today, on May 9th I have been having diarrhea and intermittent slight chest pain when taking a full deep breath. I am still very fatigued but my fever is gone. Headache and body aches persist, though not nearly as severe.
31 2021-05-09 sensitivity to light 15 minutes status post 2nd dose vaccine, client complained of headache, nausea and dizziness. Medic ... Read more
15 minutes status post 2nd dose vaccine, client complained of headache, nausea and dizziness. Medic made contact with client and noted she was CAOx4. Medic reported client tried to stand but was unsteady on her feet and was helped back into her chair. Client reported symptoms of nausea, headache (HA) and dizziness following her first dose Pfizer COVID vaccine received but said symptoms began late evening of 1st dose. This time she stated they began 15 minutes following 2nd dose. Client claimed last oral intake of food/water at 1100. Client remained in original seat for 15 minutes stating she felt more comfortable. Client was provided an emesis bag and water bottle. At 1145 baseline vital signs (VS) obtained while sitting: blood pressure (BP): 118/78, Heart rate (HR): 82, respiration rate (RR): 18, CAOx4, pupils equal, round and reactive to light (PEARL), and skins were pale, warm and dry. Client rated HA a 7/10 on pain scale and stated pain was in frontal/temporal region. Client positive for photophobia, nausea, dizziness and stated pain had a stinging sensation. Denied radiating pain, shortness of breath, chest pain, abdominal, neck or back pain. Client denied recent trauma or illness, changes in lifestyle, diet, or prescriptions. Client was stable enough to transfer to zero gravity chair on her own accord. At 1200 second set of VS while sitting: BP: 118/70, HR: 69, RR: 16, CAOx4, PEARL, skins pink, warm, and dry. Client reported history of migraines and stated her prescription Sumatriptan would help. Client called a friend to bring her medication. Client was offered Emergency services (EMS) but declined. At 1207 orthostatic pressures attempted but unable to perform due to client stumbling back from dizziness. Medic caught client and assisted back to zero gravity chair. EMS offered again and client adamantly refused stating she will wait for medication. At 1210 Client reassessed and claimed no change in status. At 1247 Client's friend arrived with Sumatriptan. Client self administered 1 tablet. Client continued to complain of HA but stated nausea and dizziness subsiding. At 1300 client reported 5/10 HA and diminishing intensity. At 1307 client stood on own accord for orthostatic pressures which were negative, skins normal for ethnicity and dry, PEARL, negative for respiratory distress. Client reported 3/10 HA and denied other symptoms. Client departed at 1315 on her own accord with a steady gait.
31 2021-05-09 swelling of eyelid, eye pain My left eye lid became swollen the next day after both of my Pfizer vaccines, gave me flank pain and... Read more
My left eye lid became swollen the next day after both of my Pfizer vaccines, gave me flank pain and raised my blood sugars. Also I currently still have eye pain behind both of my eyes.
31 2021-05-09 ringing in ears Tinnitus developed in my left ear around 36 hours after the 2nd Pfizer shot. Currently still have th... Read more
Tinnitus developed in my left ear around 36 hours after the 2nd Pfizer shot. Currently still have the ringing in my ears. Causing a lot of distress.
31 2021-05-10 vision blurred, lip swelling Pt became shaky, throat felt itchy. Complained of chest feeling tight. Benadryl 25mg IM given at 104... Read more
Pt became shaky, throat felt itchy. Complained of chest feeling tight. Benadryl 25mg IM given at 1045. Complained of spotty vision. Pt reported having filler in lips a few days ago. Wheezing in left lung, Epi given at 1101. Pt left with EMS 1125.
31 2021-05-11 ear discomfort, ear pain Beginning 12 hours after 2nd vaccine: felt pressure around ears, weak hands & ankles, intense chills... Read more
Beginning 12 hours after 2nd vaccine: felt pressure around ears, weak hands & ankles, intense chills. Fever lasted for 15 hours and varied between 99.5 degrees up to 101.2 degrees. Followed by muscle pain, body aches, ear pain, and headache for another 5 hours. Over that 20 hour period of symptoms, 1 does of Advil and 1 dose of Ibuprofen was taken. All symptoms subsided by 2nd day after vaccine.
31 2021-05-11 lip swelling, tongue itchiness, lip itchiness Patient presented to health clinic with concern for ongoing allergic reaction potentially due to Pfi... Read more
Patient presented to health clinic with concern for ongoing allergic reaction potentially due to Pfizer vaccine. She received her first Pfizer dose about 3 weeks ago with some fatigue side effects afterwards but no additional reaction. She received her second dose on Fri 5/7 and developed swelling and itching of the lips, tongue, uvula that evening. She denied SOB or abdominal pain, no dizziness. She had a telehealth appt with an ER doc that day and they prescribed 50mg prednisone daily x1 week as well as daily benadryl and pepcid. She was also given an epipen to take with her. She started taking the medications and the symptoms resolved, however, she forgot them at home this morning and now has developed throat itching without swelling. She has no additional symptoms, no abd pain, no dyspnea, no rashes. She denies any hx of anaphylaxis, she had one episode of hives from an unknown source years ago but no additional known allergies. Vital signs are normal today.
31 2021-05-11 thirst Tiredness the day after the vaccine - for one day (25th) - on the 26th - I was noticing a loss of my... Read more
Tiredness the day after the vaccine - for one day (25th) - on the 26th - I was noticing a loss of my first trimester symptoms - and I had no nausea or tiredness - it was nice but it was kind of scary because it was unusual. That lasted for four days. Then I had excessive thirst - if I just finished a 14 oz of water, I needed to drink another one - I felt thirsty all the time. It started around the 19th of April. I messaged my doctor. That lasted until the 28th of April. Dr recommended I sip on Pedialyte , too, instead of water only. Pregnancy - 1st pregnancy; Estimated date of delivery - 10/28/2021
31 2021-05-12 blindness, ringing in ears The evening after her second COVID shot, the patient experienced a 10-minute seizure where she was u... Read more
The evening after her second COVID shot, the patient experienced a 10-minute seizure where she was unable to move or uncurl her fists. Afterwards, she began to loosen-up, hyperventilate and then passed out twice. After this, she lost vision for 5 minutes. Then she became very hot with profuse sweating, ringing ears and dizziness. She then got cold sweats and chills for about 30 minutes. After this, she still had some tension in her calves. It took another 30 minutes before she was able to walk again. She took some Tylenol for the pain. Later, when she took her temperature, it was normal. She has been tired and resting since the incident but has not had any more seizures.
31 2021-05-12 taste impairment, mouth tingling, mouth numbness, feeling of choking Tasted bitterness in mouth about 1 minutes after injection, back of throat and tongue started to tin... Read more
Tasted bitterness in mouth about 1 minutes after injection, back of throat and tongue started to tingle and feel numb about 5 mins after injection, slightly lightheaded. Entirety lasted for 30 minutes or so.
31 2021-05-12 taste impairment, mouth tingling, feeling of choking Tasted bitterness in mouth about 1 minutes after injection, back of throat and tongue started to tin... Read more
Tasted bitterness in mouth about 1 minutes after injection, back of throat and tongue started to tingle and feel numb about 5 mins after injection, slightly lightheaded and tingles when down shoulders to hands after 10 minutes. Entirety lasted for 30-45 minutes or so.
31 2021-05-12 vision blurred Blurred vision, vertigo, dizziness, lightheaded lasting 10 days or more. As a result I?ve had diffic... Read more
Blurred vision, vertigo, dizziness, lightheaded lasting 10 days or more. As a result I?ve had difficulty driving and taking care of my child
31 2021-05-13 taste impairment On 4/29/21 she reported a metallic taste in her mouth. on 4/30/21 she had foggy brain, forgetfulnes... Read more
On 4/29/21 she reported a metallic taste in her mouth. on 4/30/21 she had foggy brain, forgetfulness. The metallic taste and foggy brain continued until the next week. On 5/5/2021 she reported she had a day with God and had several encounters throughtout the day that she stated she was receiving messages from God. Thursday 5/6/2021 she remained home with family and was continously religously preoocupied, paranoid, ranting about the day prior that she had spent with God, mentioned she had been tremboling all day long because she was in the present of God. The next day she couldnt put her thoughts together, disorganized thinking, she had forgetten basic skills of everyday living and how to accomplish them. Laughing and crying at inappropriate times. She was then on 5/7/2021 around 3pm taken to the ER to be evaluated. In the ER she was yelling and screaming responding to voices, hallucinating, delusional. She had to be physically and chemical restrained. They were unsuccessful in stabilizing her and identifying any cause except for post COVID vaccine psychosis and was transferred to psychiatric Hospital for further evaluation and treatment. Which she has been at for 6 days with no improvement. She has not responded to any treatment given.
31 2021-05-13 eye swelling, lacrimation increased, eye pain, bloodshot eyes headaches; runny nose; red, teary and painful eyes; red, teary and painful eyes; red, teary and pain... Read more
headaches; runny nose; red, teary and painful eyes; red, teary and painful eyes; red, teary and painful eyes; She woke up with pain and swollen red watery eyes; This is a spontaneous report from a contactable consumer (patient, self-reported). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3248 and expiry date was not provided), via an unspecified route of administration, in Arm Left, on 27Jan2021 at 12:00 o'clock noon, as a single dose for COVID-19 immunization at local hospital. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that she was administered with the first dose of the vaccine yesterday. On 27Jan2021, at night, around 7 pm and after that her eyes started getting red and the headache started, and also had a runny nose, red, teary and painful eyes. After midnight, either being 27Jan2021 or 28Jan2021, she had very huge pain in both eyes and swelling as well as the wateriness in the eyes. It wasn't tolerable and so she started having Tylenol. She woke up with pain and swollen red watery eyes. She started having eye drops and that helped but she was still having pain. Her headache went away last night when she slept. She did not have positive COVID test or Antibody test before the vaccine. She did not have any issues with vaccines in the past. Outcome of the event headache was recovered on an unknown date. Outcome of the event runny nose was unknown and for all other events, it was not recovered. Follow-up attempts are completed. No further information is expected.
31 2021-05-14 swelling of eyelid bloody stool; Yeast infection; swollen upper eyelid; This is a spontaneous report from a contactable... Read more
bloody stool; Yeast infection; swollen upper eyelid; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 17:00 at the age of 31 years old (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The patient experienced yeast infection, bloody stool, swollen upper eyelid on 13Apr2021. The patient did not receive treatment for the events. The outcome of the events was not recovered. Information about Lot/Batch number is obtained. Additional information has been requested.
31 2021-05-15 dry mouth, eye discomfort Joint soreness in my hips making standing, walking, and sitting very uncomfortable and painful. Skin... Read more
Joint soreness in my hips making standing, walking, and sitting very uncomfortable and painful. Skin highly sensitive and tender to the point where it was unpleasant to have my clothes brush it. Head congestion and fullness, terrible headache and pressure behind my eyes. Sore throat and dry mouth.
31 2021-05-15 vision blurred Immediately after vaccination when waiting in the 15 min wait area, my wife experienced blurred visi... Read more
Immediately after vaccination when waiting in the 15 min wait area, my wife experienced blurred vision while looking at her mobile phone. We have assumed it to be due to the bright sunlight. However it got worse over a period of time. Over the period of next few days every morning when she woke up she felt the vision for further detoriated. We have consulted opthomologist but they have mentioned the eye looks good, it might be temporary and suggested to use glasses. It?s worrying that the vision got worsened in a weeks time. Prior to this there was no problem with vision. Currently my wife is nursing a 6 month baby.
31 2021-05-16 dry mouth Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: dry mouth-Mild, Systemic: Shakin... Read more
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: dry mouth-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient states she has intermittent tingling in her extremeties, no definitive diagnosis by her providers.
31 2021-05-16 pain in jaw, vision blurred, taste impairment Immediate: severe nausea/dizziness (room spinning) and a strong constant metallic taste 1 hour follo... Read more
Immediate: severe nausea/dizziness (room spinning) and a strong constant metallic taste 1 hour following: neck swelling, jaw pain/tingling, face numbness, arm numbness (Right arm) - patient took 25 mg Benadryl po 2 hours after: weakness (difficulty ambulating) and foot itchiness/tingling 8 hours after: facial numbness/blurred vision
31 2021-05-18 drooping eyelid Flare of myasthenia gravis symptoms, including shortness of breath (due to muscular weakness), diffi... Read more
Flare of myasthenia gravis symptoms, including shortness of breath (due to muscular weakness), difficulty swallowing, ptosis, generalized extremity fatigue. Required hospitalization and administration of IVIG over two days. Improvement of MG symptoms noted following IVIG administration.
31 2021-05-18 swelling around the eyes, lip swelling After 12 hours from vaccine I had diarrhea; chill; swelling all my body; puffy both eyes and lips; p... Read more
After 12 hours from vaccine I had diarrhea; chill; swelling all my body; puffy both eyes and lips; puffy both eyes and lips; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 03May2021 14:00 (Batch/Lot number was not reported) as single dose at the age of 31-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. No other vaccine in four weeks. No COVID prior vaccination. No known allergies. Other medical history: she never had any reaction. On 04May2021 04:00 after 12 hours from vaccine she had diarrhea, chill, swelling all her body, puffy both eyes and lips. Events resulted in Emergency room/department or urgent care and Hospitalization. Therapeutic measures were taken as a result of events. COVID was not tested post vaccination. The outcome of events was recovered with sequelae. Information on the Lot/Batch number has been requested.
31 2021-05-18 taste disorder Neck Pain Nausea Funny taste Dizzy Almost Blacked out
31 2021-05-19 pain in jaw A high grade fever/fever; Chills; Inability to get warm; I had pain down my injection arm into my fi... Read more
A high grade fever/fever; Chills; Inability to get warm; I had pain down my injection arm into my fingers, up my neck and into my jaw; I had pain down my injection arm into my fingers, up my neck and into my jaw; I had pain down my injection arm into my fingers, up my neck and into my jaw; Myalgia and Arthralgia total body; Myalgia and Arthralgia total body; Pounding headache/Headache off and on/headaches; Sweat through 3 outfits/sweat through my clothes; Issues with temperature regulation; Fatigue; This is a spontaneous report from a contactable other hcp (patient). A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 31Jan2021 14:50 (Batch/Lot Number: EL3249) as single dose for COVID-19 immunisation. Medical history included allergy to allegra (medication) and many foods (fresh fruit, wheat, rye, oats, barley, soy, almonds). The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 (lot number Ek9231) in the right arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received the vaccine at 2:50pm. By ~midnight (01Feb2021, 12.00am) she developed a high grade fever (unable to take, but she would guess between 101-103 based on symptoms). She had fever and chills, with inability to get warm for hours. She had pain down her injection arm into her fingers, up her neck and into her jaw that lasted for at least an hour. Myalgia and Arthralgia total body the first night. The next day she continued to have a fever but decided to take IB profen (Ibuprofen) due to a pounding headache. Within 1 hour the headache subsided and her fever improved. That night her fever spiked again to 101 (able to check this time). No chills, but she sweat through 3 outfits. Headache off and on. Next day she continued to sweat through her clothes and her fever maintained at 99.0. All of her symptoms lasted for 3 full days and on the 4th day she still was experiencing issues with temperature regulation, headaches and fatigue. She took tylenol and IB profen about 24 hours after the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events chills, inability to get warm, Myalgia and Arthralgia total body and pain down her injection arm into her fingers, up her neck and into her jaw was recovered on 01Feb2021 and other events was recovered in Feb2021. Follow-up attempts are completed. No further information is expected.
31 2021-05-20 lip swelling Approximately 21 hours after receiving the vaccine, my lips started to swell . I also experienced fe... Read more
Approximately 21 hours after receiving the vaccine, my lips started to swell . I also experienced fever, chills, muscle aches, which I know is normal. I contacted my primary care physician due to the lip swelling and they prescribed me Benadryl and prednisone. I did nothing out of the ordinary, nor did I eat any new foods or take any different medication. I did get lip injections done in January 2020.
31 2021-05-20 mouth tingling, mouth numbness Patient c/o tongue feeling numb and tingling after vaccination. No throat constriction or shortness ... Read more
Patient c/o tongue feeling numb and tingling after vaccination. No throat constriction or shortness of breath. Speech clear, no difficulty swallowing. Denied rash or itching. Given Fexofenidine 60 mg by mouth. Advised to go to ER for evaluation but patient refused. Vital Signs stable . O2 sat 98% and 99 %.Patient had vaccination at 2:37 pm. Reaction was reported at 2:55 pm.Patient left clinic at 3:28 pm
31 2021-05-21 eye irritation, eye strain mild hallucinations; nauseated; extremely fatigued; eyes heavy with a slight burning sensation; eyes... Read more
mild hallucinations; nauseated; extremely fatigued; eyes heavy with a slight burning sensation; eyes heavy with a slight burning sensation; in a head fog state; mild headache; sick; chills; nose run; sneezing; that were so cold it; This is a spontaneous report from a contactable consumer(patient). A 31-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EW0176), via an unspecified route of administration at Arm Left on 06-MAY-2021 12:45 at the 31 years old at single dose for COVID-19 immunization. The medical history was not reported. The concomitant medication was ethinylestradiol, ferrous fumarate, norethisterone acetate(JUNEL FE) The patient previously took steroids and experienced known allergies Tendency. After the initial dose, the patient began to feel nauseated on 06May2021 14:00. The patient waited for the 15min period on site and then proceeded home. By time the patient arrived home, the patient was extremely fatigued and her eyes heavy with a slight burning sensation on 06May2021 14:00. The patient spoke to her mom briefly and she recalls that the patient told her that she got the vaccine. She also stated that the patient rambled off some strange vaccine name and statics on it which the patient have no memory of. During this time the patient had mild hallucinations on 06May2021 14:00. The patient saw her walk by and asked her where she went and she had never moved from her chair. The patient went to her room to rest/sleep immediately after where the patient remember hearing someone come in and lay down but there was no one. The patient also vividly remember waking up and checking the time which was incorrect as well. The patient was in a head fog state on 06May2021 14:00. The patient had a mild headache on 06May2021 14:00. Later that night the patient ate some food and was sick after. While going to bed, the patient had chills that were so cold it made my nose run and the patient was sneezing excessively on 06May2021 14:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. There was no treatment received for all of events. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.
31 2021-05-21 tunnel vision Suddenly felt nauseous, weak/faint with profuse sweating and tunnel vision followed by severe diarrh... Read more
Suddenly felt nauseous, weak/faint with profuse sweating and tunnel vision followed by severe diarrhea and inability to stand up for about an hour.
31 2021-05-21 vision blurred Severe dizziness, headaches, blurred vision and brain fog. It is 5 weeks and still cannot drive
31 2021-05-23 mouth tingling 10 minutes after injection I developed tingling to the left side of my face, initially only effectin... Read more
10 minutes after injection I developed tingling to the left side of my face, initially only effecting my lips and mouth. This progressed over the next 24 hours to include my eye, and cheek. It continued to progress to my forehead and downward my left arm 30 hours post injection. I sought medical attention and was diagnosed with parsesthesis. 30 hours post vaccine when the tingling was at its worst I developed a fever, muscle aches, and general malaise, I treated with 600mg ibuprofen PO. The tingling now 48 hours post vaccine has improved however is not completely resolved.
31 2021-05-24 mouth numbness, lip swelling Lower lip became swollen and numb.
31 2021-05-25 swelling of eyelid, ear swelling scattered rashes; Rashes, redness on her face and neck; Itching all over the body; swelling of eyeli... Read more
scattered rashes; Rashes, redness on her face and neck; Itching all over the body; swelling of eyelids; Itching of ear; Redness of ear; Swelling of right ear; This is a spontaneous report from a contactable health care professional, the patient. A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142; DOSE NUMBER: 1) via unspecified route of administration on the left arm on 31Dec2020 at 08:00 (at the age of 31-year-old at vaccination) as a single dose for COVID-19 vaccination. On 21Jan2021 at 11:00, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262; DOSE NUMBER: 2) via unspecified route of administration in the left arm. Medical history of the patient included cholecystectomy in 2014. The patient was allergic to Norgestimate and Ethinyl estradiol (TRINESSA). Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received concomitant medications within 2 weeks prior to the COVID vaccine, but details were not provided. On 04Feb2021, the patient started having redness, itching and swelling on her right ear and continued on 05Feb2021. On 06Feb2021, it extended towards her upper cheeks. On 07Feb2021, event spread to left ear. On an unknown date, the patient also had swelling of eyelids, itching all over her body and scattered rashes. The patient took Cetirizine hydrochloride (ZYRTEC) for two days with no relief and switched to Diphenhydramine hydrochloride (BENADRYL) for two days and still had no relief. The patient went to the emergency department for fear of her throat closing, scheduled for a dermatologist who prescribed her a steroid cream (unspecified) for 2 weeks, which worked. But after 2 weeks, she had to stop the cream. Since then, she had nonstop itching all over her body. Patient also had intermittent swelling of eyes and, rashes, redness on her face and neck till the date of report. Any other antihistamine did not work for her. The clinical outcome of the events redness, itching and swelling on right ear, swelling of eyelids, itching all over her body, scattered rashes and, rashes, redness on face and neck was not resolved. No follow-up attempts are possible. No further information is expected.
31 2021-05-26 loss of smell, oropharyngeal discomfort, loss of taste First vaccine 3/29/2021 Second vaccine 4/19/2021 Noticed Altered (vanished) taste and smell 5/2/2021... Read more
First vaccine 3/29/2021 Second vaccine 4/19/2021 Noticed Altered (vanished) taste and smell 5/2/2021 Taste mostly returned 5/9/2021 Thump in chest/ throat started 5/10/2021 More frequent chest/ throat thumps 5/14/2021 Thump then sharp pain in back of head 5/15/2021 Started feeling full/bloated/ difficult to breath 5/20/2021 (1 and a half days) Continued random heart thump/palpitation/scrub feeling 5/27/2021. This has been consistent since it?s start, becoming more frequent with an occasional headache accompanying. The headaches are not new, but when paired with the palpitation/PVC or whatever is happening, the headaches are worse.
31 2021-05-26 dry throat Severe headache; increased heart rate avg. 103 bpm; very dry throat; This is a spontaneous report fr... Read more
Severe headache; increased heart rate avg. 103 bpm; very dry throat; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot number: Unknown) via an unspecified route of administration in Right Arm on 06Feb2021 at 03:45 PM as 2nd dose single and first dose via an unspecified route of administration on 16Jan2021 at 11:00 PM as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any vaccine in 4 weeks and 2 weeks prior vaccination. The patient did not tested covid prior and post vaccination. Patient was having no allergies. On 07Feb2021 at 09:00PM, the patient experienced severe headache, increased heart rate avg. 103 bpm and very dry throat. The patient did not receive any treatment. The patient underwent lab tests and procedures which included heart rate: increased heart rate avg. 103 bpm on 07Feb2021. The clinical outcome of the events was not recovered. Information about Lot/batch number has been requested. Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
31 2021-05-26 lip pain, lip blister, lip swelling, swollen tongue Throat was super tight; Tongue swelled; It felt weird. Her oxygen was fine in the ER, but it felt al... Read more
Throat was super tight; Tongue swelled; It felt weird. Her oxygen was fine in the ER, but it felt almost heavy like there was something heavy on her.; Super exhausted; She took a nap and when she woke up her neck was stiff.; Dizzy; Lips swelled; she experienced some kind of allergic reaction; Throat was kind of itchy; When she had the lip swelling, it was like little blisters on her lips mainly on her top lip; Her lips are a little sore still in that spot with the blister, and it is a tiny bit swollen; is like a dry patch of skin, but kind of like a blister; This is a spontaneous report received from a contactable consumer (patient). A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE 2), dose 1 via an unspecified route of administration, administered in right arm on 19Apr2021 (Lot Number: EW0162) at the age of 31 years, as a single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism, allergic reaction to bee sting. Concomitant medications taken within two weeks of vaccination included levothyroxine/liothyronine (NP THYROID) taken for hypothyroidism. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took levothyroxine for hypothyroidism. On 08May2021 the patient experienced lips swelled, throat was kind of itchy. When she had the lip swelling, it was like little blisters on her lips mainly on her top lip, is like a dry patch of skin, but kind of like a blister. Her lips are a little sore still in that spot with the blister, and it is a tiny bit swollen. On 09May2021 the patients throat was super tight, her tongue swelled, it felt weird. Her oxygen was fine in the emergency room (ER), but it felt almost heavy like there was something heavy on her. Patient was super exhausted, she took a nap and when she woke up her neck was stiff, she was also dizzy. The patient visited the emergency room due to the events. The patient received treatment for the events. The clinical course was reported as follows: After her first dose, about 19 days later she experienced some kind of allergic reaction. Her lips swelled, her throat was super tight, and her tongue swelled. She ended up in the ER, and they put her on steroids. She was supposed to get her second shot "today", but now she will get it in 2 weeks. She needed to know if this was a common reaction. The reaction happened on Saturday 08May2021 the day before Mother's Day. She took Benadryl a couple of times on 09May2021. Around noon 09May2021 she went to the ER. She has no NDC, lot, or expiration date available for the Benadryl, it is at her house and she is currently at work. It was Waldryl, the store version the of Benadryl. When she had the lip swelling, it was like little blisters on her lips mainly on her top lip. The next day her bottom lip was swollen. Her tongue got big and her throat was super tight. It felt weird. Her oxygen was fine in the ER, but it felt almost heavy like there was something heavy on her. That's why she decided to go to the ER. She was already on Waldryl for a day and a half, and her lip had swelled out more and her tongue had swelled. She called urgent care, and they didn't have an appointment until 16:00 that day. They told her to go to the ER. She had taken more Waldryl before she went to the ER so her tongue was not as swollen but her lips were pretty swollen. She has a little bit of swelling on the left, kind of like a dried blister on her top lip. It is like a dry patch of skin, but kind of like a blister. It is weird. As far as her lips there is not near as much swelling now. They gave her a shot of steroids in the ER and then put her on steroids. It is Prednisone, 20mg for 3 days. NDC: #. She does not see an expiration date or a lot number on the bottle. Her throat was kind of itchy but it wasn't tight on Saturday. She tried to go to an event on Sunday and left and came home by 11:30. She thinks the Waldryl was getting to her. She was super exhausted and dizzy. She took a nap and when she woke up her neck was stiff. Her itchy throat has gone away. It was probably yesterday when she didn't notice it anymore. She hasn't noticed it yesterday or today. She doesn't know what steroid shot they gave her or if it was Prednisone or not. They just said it was a steroid shot. She doesn't feel any throat discomfort or anything anymore. She has no more discomfort in her throat or her neck. Her lips are a little sore still in that spot with the blister, and it is a tiny bit swollen. It is her left upper lift. She has braces so when her lip swelled it could have irritated her lip. The tightness in her throat went away Sunday night or Monday morning. She doesn't really remember when it went away. She remembers not really noticing it yesterday. When she woke up from her nap her tongue was swollen and her throat was tight. She went to the ER. The swelling in her tongue and her throat went down. She doesn't remember when it went away. She hasn't been feeling good and has been out of it. She takes her last steroid tomorrow, and they wanted her to wait 2 weeks after that to get the second shot. She has to call and schedule because they only schedule a week out. She has to call back in a week or so and schedule it. The heavy feeling is gone. Everything went away at about the same time. She doesn't know when it went away. She has not noticed it yesterday or today. The steroid may have helped. She is still exhausted and kind of out of it. It could be from the steroid she is sure. She is not used to medications like that. Feeling out of it and the exhaustion still feel the same since they started. She is still dizzy. It is a little better, it is not as bad. She doesn't really know when her stiff neck went away. She has been out of it. She doesn't remember when it stopped or anything. She hasn't noticed it today. Investigations: They didn't do any bloodwork or x-rays or anything. They just gave her a steroid shot. She thought she was having a reaction to a candle. She had a candle that she burned several times in her house and never had a reaction to, but she assumed it was a reaction to that. It was the only thing around that was different, she blew out the candle. She thought it was a reaction to the candle and they weren't positive, so they gave her the steroid. The clinical outcome of throat was kind of itchy, throat was super tight, and neck was stiff, was recovered. The clinical outcome of the events was lips swelled, and dizzy was recovering. The clinical outcome of when she had the lip swelling, it was like little blisters on her lips mainly on her top lip, and super exhausted, was not revered. The clinical outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.
31 2021-05-26 lip swelling, lip pain Lip swelling and pain/swollen to 4x the regular size of lip; Lip swelling and pain/swollen to 4x the... Read more
Lip swelling and pain/swollen to 4x the regular size of lip; Lip swelling and pain/swollen to 4x the regular size of lip; This is a spontaneous report from a non-contactable consumer (patient, herself). A 31-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0178 and expiry date was not provided), via an unspecified route of administration, administered in Arm Left on 19May2021 13:15 (at the age of 31-years old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19. No known allergies. No other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 21May2021 12:00 AM, the patient experienced lip swelling and pain, swollen to 4 times the regular size of lip. No treatment received for the events. Seriousness of the events was reported as non-serious. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
31 2021-05-26 vision blurred, mouth numbness bleeding; headaches; facial pain; hot flushes; breathlessness; severe body aches; upset stomach; sku... Read more
bleeding; headaches; facial pain; hot flushes; breathlessness; severe body aches; upset stomach; skull pain; numbness in lips; blurred vision; This is a spontaneous report received from a contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 04May2021 17:30 (Batch/Lot Number: EW0165) (age at vaccination: 31 years old) as single dose for COVD-19 immunisation. The patient had received dose 1 of BNT162b2 on 13Apr2021 17:00 (Batch/lot number: EW0162) administered in left arm for COVID-19 immunization. The patient had no relevant history, no prior drug, no known allergies. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. The patient had not had COVID prior to the vaccination, unknown if tested post the vaccination. The patient experienced severe headaches, facial pain, hot flushes, bleeding, breathlessness, severe body aches, upset stomach, skull pain, numbness in lips, blurred vision. Event onset date wsa 07May2021 at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It's unknown if any treatment was received for the events. The events were not resolved.
31 2021-05-27 ear discomfort, ringing in ears Bilateral tinnitus, onset 5 days after the first shot of Pfizer/BioNTech. Initial loud spike, volume... Read more
Bilateral tinnitus, onset 5 days after the first shot of Pfizer/BioNTech. Initial loud spike, volume 9/10. Accompanied by a sensation of heat and discomfort in the ears and back of the head. Tinnitus stayed loud for about a week. Disrupted daily activities. Admitted to the ER, did not respond to dexamethasone IV. Progressively started improving over the following weeks. Still ongoing more than two months from the vaccine. Louder at night and early morning.
31 2021-05-27 eye discharge, eye swelling, eye irritation, conjunctivitis Pfizer-BioNTech COVID-19 Vaccine EUA: one day after receiving vaccine patient presents to urgent car... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: one day after receiving vaccine patient presents to urgent care with left eye swelling, drainage, and burning sensation. Patient also reports nasal congestion for one month. Diagnosed with sinusitis and acute conjunctivitis, possibly due to COVID-19 vaccine, virus, bacteria, foreign body, or chemical/mechanical injury. Prescribed oral and ophthalmologic antimicrobials. Discharged to home.
31 2021-05-27 visual impairment, vision blurred, bloodshot eyes I got the vaccine and I experienced very slightly blurry vision 15 minutes after. My vision detorora... Read more
I got the vaccine and I experienced very slightly blurry vision 15 minutes after. My vision detororated very bad so I couldn't read my phone or laptop in a weeks time. I contacted my primary care 2 days after this happened and she referred me to a Ophthalmologist, and then the Ophthalmologist referred me to a Retinal Specialist who said nothing seems wrong and to use reading glasses temporarily. And so after that I contacted the Optometrist to get the proper glasses because over the counter glasses werent working well. There has been reddness in my eyes so I;ve been using eye drops for more than a month. I"m nursing and also had the Lasik done 5 years ago because childhood distance vision problem. I used glasses when I was younger and did surgery to stop using them. Since vaccination my near and distance vision got really bad, now the distance is a little better but near is still very bad.
31 2021-05-28 photosensitivity reaction headaches; Extreme light sensitivity; migraines; This is a spontaneous report from a non-contactable... Read more
headaches; Extreme light sensitivity; migraines; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: Unknown), via an unspecified route of administration on 28Feb2021 at 07:45 as single dose for covid-19 immunization in hospital. The patient medical history was not reported. No known allergies were reported. Concomitant medication included drospirenone, ethinylestradiol (OCELLA) for birth control and vitamins, both received in two weeks. No other vaccine received in four weeks. Patient was not tested positive for Covid prior vaccination. On 28Feb2021 at 21:00, the patient experienced extreme light sensitivity and headaches (patient was not prone to headaches, so she believed these to be migraines). No treatment was received for events. Patient was not tested Covid post vaccination. The outcome of events was recovered in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
31 2021-05-29 smell distorsion, eye pain, ear pain Vomiting, upset stomach, weird pains in stomach, back pain, joint pain, muscle pain, odd headaches, ... Read more
Vomiting, upset stomach, weird pains in stomach, back pain, joint pain, muscle pain, odd headaches, foul smelling urine, body aches, light numbness in a extremities, fatigue, slight burning sensation in back, pain in lower left back that's tender to the touch, restless legs, shoulder pain (injection site), congestion, stuffy nose, running nose, earaches, smelling odd smells, slight chills, slight shaking, neck pain, aching eyes, slightly puffy face, odd feeling in chest.
31 2021-05-30 mouth numbness Within 1 hour of vaccine, she got tongue numbness, throat itching. It lasted a couple of hours. Recu... Read more
Within 1 hour of vaccine, she got tongue numbness, throat itching. It lasted a couple of hours. Recurred with second dose but not as severe.
31 2021-06-01 loss of smell KIDNEY FAILURE; Neurological disorder; Headache; anosmia; COVID-19; 2nd dose on 01Jan2021; 2nd dose ... Read more
KIDNEY FAILURE; Neurological disorder; Headache; anosmia; COVID-19; 2nd dose on 01Jan2021; 2nd dose on 01Jan2021; This is a spontaneous report from a contactable physician. A 31-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EL8982), dose 2 intramuscular, administered in Deltoid Left on 01Jan2021 as an unspecified dose for covid-19 immunisation. Patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot number: EL0142) on 29Dec2020 via R deltoid intramuscular as unspecified route for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a history of diabetes: Borderline and the patient was a non-smoker/former. It was stated patient have a positive test for SARS-Cov2 and New infection Dxdt RT-PCR was done on 06Jan2021 and patient have SARS-CoV2 antibodies at diagnosis was unknown. Patient willing to be contacted again by Pfizer on the reported adverse event. It was reported that patient experienced Covid a week after the 1st dose of the vaccine. When to get the 2nd dose/tested positive for COVID 04Jan2021. There was a Renal failure on unspecified date. And no other details were provided and Neurological is Yes, and no details were provided. Other provided as Yes as headache, anosmia. The patient was not hospitalized and the patient was not admitted to an Intensive Care Unit. The patient display no clinical signs at rest indicative of severe systemic illness. The patient does not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Patient does not have Mutliorgan failure, Respiratory, Dyspnea, Tachypnea, Hypoxemia and COVID-Pneumonia was Unknown, No Respiratory failure and no Acute respiratory distress syndrome (ARDS). Patient had no Cardiovascular, Heart failure, Cardiogenic shock, Acute myocardial failure, Arrhythmia, Myocarditis, Gastrointestinal/Hepatic, Vomiting, Diarrhea, Abdominal pain, Jaundice, Acute liver failure, Other, Vascular, Deep vein thrombosis, Pulmonary embolism, Limb ischemia, Vasculitis, Renal and Unknown Acute kidney injury. The was no altered consciousness, Convulsions/Seizures, Encephalopathy, Meningitis, Cerebrovascular accident. There was no Hematological, Thrombocytopenia, Disseminated intravascular coagulation, Other, Dermatological, Chillblains, Erythema multiforme. patient had not received any additional therapies for COVID-19. the event does not require the initiation of new medication or other treatment or procedure. Patient did not retest from the SARS-CoV2 diagnosis before the SARS-CoV2 antigen test became negative. It was reported that Laboratory Test or Diagnostic Studies: Test for SARS-CoV-2 by PCR, or other Performed on 06Jan2021 Results with units as Positive. The patient has not been taking any medications routinely prior to the event being reported. Patient do not have any pre-existing diseases worsened during the SARS-CoV2 infection. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The outcome with COVID-19 was recovered and the remaining events were unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Renal failure,covid 19 anosmia,headache. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate
31 2021-06-01 smell distorsion rregularities in my menstrual cycle such as heavy bleeding and very large clots (2-3 in in size); ir... Read more
rregularities in my menstrual cycle such as heavy bleeding and very large clots (2-3 in in size); irregularities in my menstrual cycle; terrible headache and stomach pain like none I had ever had before 10/10 pain scale; stomach pain; my sense of smell was off and still is. It's like a rancid smell?; unable to go about my daily activities; extremely fatigued; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7533 and expiration date not provided), via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:45 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history includes Scoliosis, migraine, and COVID-19 on 13Jan2021 (lost my sense of smell for 5 days but it returned without any issues and I had only minimal symptoms). The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. On 22Apr2021 15:00, the patient experienced terrible headache and stomach pain like none I had ever had before 10/10 pain scale. The patient took 2 tablets of 500 mg of acetaminophen to treat the pain but it had no effect. After 8 hours past I then took 3 tablets of 200 mg ibuprofen which still had no response to pain. The patient sense of smell was off and still is. It is like a rancid smell? I gave it some time to see if it would go away but it is still present. The patient also experiencing irregularities in my menstrual cycle such as heavy bleeding and very large clots (2-3 in in size). It has made me unable to go about my daily activities and I have been extremely fatigued. I have never had this issue previously and am not on any kind of medications or birth control. No treatment was given for the events except for headache and stomach pain. The outcome of the event was not recovered. The patient took the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170) on 28Apr2021 administered on left arm for covid-19 immunisation.
31 2021-06-08 loss of taste, loss of smell lost my sense of taste; I lost my sense of smell; This is a spontaneous report from a Non contactabl... Read more
lost my sense of taste; I lost my sense of smell; This is a spontaneous report from a Non contactable Consumer. This 31-Years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL9264, Expiry date 31Aug2021)(At the age of 31 years-old), via an unspecified route of administration into left arm on 03Feb2021 at 14:00 PM as a single dose for COVID-19 immunisation. Medical history included Migraines. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, patient was not tested for COVID-19 Patient did not receive any other medications within four weeks. Patient stated that 2 days after receiving the first dose , On 05Feb2021 at 17:00 PM, I lost my sense of smell. On the 3rd day, I lost my sense of taste. My taste was gone for 5 days.No treatment was given for the events. The outcome of the events was reported as recovered on unknown date in 2021. No follow-up attempts are possible. No further information is expected.
31 2021-06-08 mouth numbness Following vaccine patient went to break room. This NP asked patient to return to observation area an... Read more
Following vaccine patient went to break room. This NP asked patient to return to observation area and patient stated, ' I am just getting my water bottle". A staff member notified this NP that patient "not feeling well". Patient reported that she "just needed to drink water". This NP asked the patient to return to the observation area. 1744- Patient ambulated to gurney and seated. Does not want to lay down and is saying, "I am sorry... I am fine... I am ok... This happened before...I am fine" Initial HR 102, O2 sat 98-100, RR-18, no stridor, BS CTA. Patient requesting Benadryl and reports she took Benadryl after 1st dose of Pfizer vaccine. 1746- Benadryl 50mg PO 1747- HR-86; RR-18; BP- 136/90; O2 sat 98-100% . BS CTA, no stridor. Patient itching at skin. Patient stating " I am fine... this happened before and I am fine". 1749- Patient reports 'feels like something is stuck in my throat.. my tongue feels numb'. Patient clearing throat and taking sips of water. Advised patient that we would give a shot in her leg to help stop reaction and that we would be calling 911. Patient agrees to IM epinephrine. Attempted to have patient lie down, but patient reports difficulty breathing while laying down. EMS activated 1751- Epipen 0.3mg/0.3ml administered in Left thigh. HR-100; RR-18; BP 150/96; O2 sat 98%. Patient awake alert, speaking in full sentences. BS with faint exp wheezes in LLL, no stridor, RR even and unlabored. 1756- HR-89; RR- 18; BP 118/ 80; O2- 98%. No rash visible, patient no longer scratching at skin or clearing throat. BS CTA, no stridor, no facial or mouth edema. Patient alert. Patient reports past reaction to kiwi where her "tongue went numb and swelled up". She reports she 'just doesn't eat it" and "did not go to doctors". Patient denies any current health issues, significant PMH, or current medications. Reports she took Benadryl last week for rash from unknown substance. She suspects reaction last week from new shampoo. 1800- EMS arrived. Patient clearing throat. Advised EMS we could give additional epinephrine. EMS asked to 'wait while we assess'. RR even and unlabored, no stridor or other sign of respiratory distress. HR-110; RR- conversing; BP- 153-103; O2- 99%. 1803- Patient ambulated to gurney. EMS informed by this NP that patient has downplayed some symptoms and that she continues to have throat clearing. EMS states they have 'epinephrine in ambulance and can administer.' EMS given administered Epipen in plastic carrying case. Patient to awaiting ambulance by gurney with EMS.
31 2021-06-08 swollen tongue Pt states she developed throat tightness, tongue felt swollen, and had a find rash that started righ... Read more
Pt states she developed throat tightness, tongue felt swollen, and had a find rash that started right after injection at 1715. She told the clinic staff about this and at 1743 she was given 50 mg benadryl and at 1746 she was given an Epi-Pen. At 1800, EMS noted she had a hoarse voice and cough, given Duoneb with improvement of symptoms. On exam in the ED at 1845, pt was asymptomatic and had not findings of throat, lip, or tongue swelling. She was breathing normally with no wheezes or stridor.
31 2021-06-09 ringing in ears Sudden onset of severe tinnitus that is described as a constant high pitched ringing noise in both e... Read more
Sudden onset of severe tinnitus that is described as a constant high pitched ringing noise in both ears. Patient has never experienced tinnitus prior to receiving the vaccine.
31 2021-06-12 ear pain, ear discomfort started having fullness/pressure in ears a few days after first vaccination...intensity increased in... Read more
started having fullness/pressure in ears a few days after first vaccination...intensity increased in following days and started feeling like "draining" was occurring but no fluid coming from ears, some ear pain and headache was accompanying these symptoms
31 2021-06-13 ear pain, eye movement disorder 5 minutes after the injection I lost function in both arms and controlling my eyes. Couldn't hold my... Read more
5 minutes after the injection I lost function in both arms and controlling my eyes. Couldn't hold my phone up. The pharmacist helped me to the floor and I began to convulse and spasm, especially on the left side. These convulsions, spasms, facial and body ticks came in waves of extreme, almost bone-breaking tension, then I would go limp, then repeat. It is day 9 after the injection and the convulsions, spasms, and general tremoring continues. Extreme overall body pain like electric shocks and vibrations that wake me from sleep when I can get it. The left side of the body worse. Blinding headaches began after 2 days. Left facial droop and generalized flat facial affect as I can't smile without spams. Eyes spasm when I try to look around. Extreme fatigue and irregular breathing (diaphragm spasm?). Grip strength impaired and I drop everything and food and liquids fall from my mouth. Sharp shooting electric pain through the left arm, neck, skull, face, ear, and shoulder blade. The ear will spasm to where my ear touches my shoulder and I can't move it. I cannot drive. And have had to be dependent on others for everything.
31 2021-06-13 photosensitivity reaction RASH IN FOREARM AND EXTERMLYITCHY. WHEN EXPOSED TO RUN THE IRRTATION INCREASE.
31 2021-06-14 deafness unilateral, ear infection Vertigo and dizziness the weeks following second dose, acute sialadenitis (resolved with Augmentin),... Read more
Vertigo and dizziness the weeks following second dose, acute sialadenitis (resolved with Augmentin), tingling, ear infection and loss of hearing in left ear for 48 hours (treated with antibiotic)
31 2021-06-14 eye disorder, mouth tingling, vision blurred, mouth numbness On 3/2 after receiving the 2nd dose I saw the optometrist again. They did different eye exams. Again... Read more
On 3/2 after receiving the 2nd dose I saw the optometrist again. They did different eye exams. Again ,they did not see anything wrong. He checked pupil dilation and noted that there was a slight delay in the left eye. Upon checking with HCP she said she did not notice any significant delay. I was able to have my vision compensated by my right eye. When my right eye vision became compromised. HCP ordered an MRI which showed a moderate to severe sinus infection and was prescribed antibiotics. The antibiotics did not help. On top of the antibiotics, I also took other medications for the sinusitis. I took the antibiotics from 4/14-4/21. After the antibiotics, on the 4/24 I noticed tingling and numbness on my face particularly from the tip of my nose to my chin and in circular area around my mouth. It is random and comes and goes through out the day, Also, on the same night of the numbness I experienced a bout of off balanced feeling and heaviness. It was a drunk feeling but I do not drink. I had 2 occurrences of this. It went away in the morning I scheduled another appt because both my left and right eye were consistently blurry. The blurriness would get worse with movement and heat. After that appt she referred me to neurology and gave another dose of antibiotics. I took that from 4/19-4/25. Nothing changed after that round of antibiotics I went to the neurology appt on 6/9, they looked at the MRI and basically confirmed that nothing was wring neurologically. They said they did not have any explanation for the symptoms. My husband asked if there was a chance the vaccine could've caused it. They said they've seen some symptoms in patients but there is no way to confirm it was the vaccine. I am still currently stuck with my loss of vision. It has prevented me from driving and doing any exercise. Many of the tasks I am able to do have been limited as well.
31 2021-06-14 eye disorder Numbness started after the second covid vaccine numbness throughout her body started in late April a... Read more
Numbness started after the second covid vaccine numbness throughout her body started in late April and early May, felt like facial droop and squeezing her left eye then saw neurologist. Has been treated with topirimate and mostly improved but still with facial numbness. Also reports new dx atypical Migraines reports they started prior to getting vaccine.
31 2021-06-14 lip swelling, swollen tongue 5/31/2021 Allergic reaction mid afternoon, hives itchy throat 6/11/2021 Allergic reaction, hives,... Read more
5/31/2021 Allergic reaction mid afternoon, hives itchy throat 6/11/2021 Allergic reaction, hives, itchy throat, swelling of the tongue/lips difficulty swallowing & breathing
31 2021-06-14 vision blurred, visual impairment Starting on 2/19, I noticed that there was blurred vision in my left eye, It got worse over the next... Read more
Starting on 2/19, I noticed that there was blurred vision in my left eye, It got worse over the next few days. I went to an optometrists on 2/22. They couldn't find anything wrong but there was significant vision loss that was constant throughout the day. It continued so I went back where I had more tests done but still, nothing was wrong. At the time of the appointment there was nothing physically wrong with the eye or never that the doctors could see.
31 2021-06-16 loss of smell, loss of taste tired; feeling dizzy; headaches; had slight flu like symptoms and was really dizzy and tired; lost t... Read more
tired; feeling dizzy; headaches; had slight flu like symptoms and was really dizzy and tired; lost the sense of smell and taste; lost the sense of smell and taste; This is a spontaneous report from a Pfizer-sponsored program received from a consumer (patient) reporting for herself. A 31-year-old female patient (31 years age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955, Expiration Date: 30Jun2021), via an unspecified route of administration in left arm on 23Mar2021 at 10:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the first dose of vaccination, she did not receive any vaccinations within 4 weeks. No additional vaccines were administered on same date of the suspect vaccine. The patient stated that 7 after vaccination on 30Mar2021, she noticed she had no smell or taste or anything and asked whether it was an allergic reaction and should she be tested for the virus. She felt very dizzy and tired, and it was a lot more severe. She added that she felt flu like symptoms and believed the event continued at the time of report. She did not require treatment or a visit to her HCP or the Emergency room. She did not receive the 2nd dose of the Pfizer vaccine at the time of report. The clinical outcomes of the events loss of smell and taste, dizziness, tiredness, headache, and flu like symptoms were reported as unknown at the time of report. No follow-up attempts are needed. No further information is expected.
31 2021-06-18 eye pain low grade fever; had extreme changes in menstrual cycle, late, irregular, more severe pms symptoms I... Read more
low grade fever; had extreme changes in menstrual cycle, late, irregular, more severe pms symptoms I have never experienced before, significantly heavier flow, more painful, shorter period of time; had extreme changes in menstrual cycle, late, irregular, more severe pms symptoms I have never experienced before, significantly heavier flow, more painful, shorter period of time; had extreme changes in menstrual cycle, late, irregular, more severe pms symptoms I have never experienced before, significantly heavier flow, more painful, shorter period of time; had extreme changes in menstrual cycle, late, irregular, more severe pms symptoms I have never experienced before, significantly heavier flow, more painful, shorter period of time; had extreme changes in menstrual cycle, late, irregular, more severe pms symptoms I have never experienced before, significantly heavier flow, more painful, shorter period of time; had extreme changes in menstrual cycle, late, irregular, more severe pms symptoms I have never experienced before, significantly heavier flow, more painful, shorter period of time; had extreme changes in menstrual cycle, late, irregular, more severe pms symptoms I have never experienced before, significantly heavier flow, more painful, shorter period of time; fatigue; migraines; irritability; eye pains; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 31-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0179, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 09May2021 at 17:00 pm (age at vaccination was 31 years) as 2nd dose, single dose for COVID-19 immunization. The patient's medical history included asthma and chronic pain. The patient had known allergies to shellfish, cilantro, celery, carrots, parsley, cumin, dill weed and latex. Concomitant medications the patient received within 2 weeks of vaccination included lamotrigine taken for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0169, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 17Apr2021 at 10:30 am (age at vaccination was unknown) as 1st dose, single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On 09May2021 at 20:00 pm, the patient started having a low grade fever by the end of the day of the second vaccine. The fever had been nonresponsive to most meds, acetaminophen was the only one to break the fever. She has had ongoing fevers for 32 days now. She has also had extreme changes in menstrual cycle, late, irregular, more severe PMS symptoms she had never experienced before, significantly heavier flow, more painful, shorter period of time. She had been experiencing fatigue, migraines, irritability, eye pains, as well. The patient received treatment for the adverse events and testing as per the medication advice. Since the vaccination, the patient has not been tested for COVID-19. The device date was reported as 11Jun2021. The outcome for the events was not resolved. Information on Lot/Batch number was available. Additional information has been requested
31 2021-06-18 mouth numbness, swollen tongue, mouth swelling itching; This ingredient started a physiological reaction where she started coughing; Mouth swelled;... Read more
itching; This ingredient started a physiological reaction where she started coughing; Mouth swelled; tongue swelled; roof of mouth was swelling and numb; roof of mouth was swelling and numb; Tingling; This is a spontaneous report from a contactable consumer A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown, at the age of 31 years), dose 1 via an unspecified route of administration on 17Jan2021 as 1st dose, single dose for Covid19 immunization. The patient's medical history included ongoing asthma Verbatim: Asthma, ongoing hypersensitivity Verbatim: Allergies, dust allergy (Allergies to dust, dandruff, coach roaches). Concomitant medications included ephedrine hydrochloride (ASTHMA [EPHEDRINE HYDROCHLORIDE]) and clarithromycin (CLARITIN [CLARITHROMYCIN]). The patient experienced mouth swelled, tongue swelled, roof of mouth was swelling and numb and tingling on 17Jan2021, this ingredient started a physiological reaction where she started coughing on 01Feb2021 and itching on an unspecified date. The reporter's daughter was a teacher. She received her first vaccine, and the minute the dose went in, she had a reaction. The medical team observed her, and she had to wait 45 minutes. She stayed with the other teacher she went to get the vaccine with until the next morning. They told her daughter, if she got worse go to the hospital. She did not got worse. The next day when she got home she called the doctor. The doctor heard her symptoms, and put her on prednisone. He also said she should have an allergy consult. She went for the consult this past Monday,01Feb2021. Her second shot is due this coming Sunday 07Feb2021. They wanted to test the ingredients of the Pfizer vaccine to see what she is allergic to. The first two she did okay with. Then on the 3rd one he injected into her, it started to swell and welt a little. All the sudden she started to cough as well. She hadn't coughed before the test. This ingredient started a physiological reaction where she started coughing. Caller doesn't know what ingredient it was. The doctor send her home with an epipen. Then for 48 hours later, yesterday , her whole body felt like she could scratch her eyes out. She was scratching all over her body and itching. It has been going on since the test Monday, and last night got worse. Yesterday, she said she felt terrible. That she was so itchy she could take an knife and scratch herself. She did her nebulizer treatment last night. The doctor also told her to double her Claritin. So she took two Claritin and a Benadryl last night. This morning she said some of the itching. It is where the area marked M from the test is. Her eyes are itching. Some of the symptoms have gotten better. The welts where the M is she could still scratch with a knife. The area with the M on it was super big inflamed and caused another welt to appear beside it. The itch and discomfort caused her to take a nebulizer last night. She called the allergist yesterday and they were closed. She got the emergency number and called him. He told her to double up on Claritin last night. So she took 2 Claritin/ She also took one Benadryl. Her daughter felt her mouth and tongue swelling immediately, and it lasted two to three days after the vaccine administration. She didn't feel better the second day. It took 2-3 days to get better. After that, she had stopped her allergy pills. She was on Claritin, but the doctor asked her to stop because of the test. Five days before the test, she had on 01Feb2021, she had stopped Claritin. She had stopped the Claritin since 27Jan2021. She was perfectly fine until they administered the lengthy allergy test. She first started coughing. That was at 2 o'clock in the afternoon. She thinks she got flu shot, but thinks that was 4 weeks before the COVID vaccine. She thinks she got it early on. Growth hormones as a child because her bone age was advanced compared to biologically. At that time she was on Low dose of dexamethasone , prednisone, and monthly Lupron shots. She has not had those since she was 12. Allergies to dust, dandruff, coach roaches. Arizona has lots of pollen, and she was constantly having sinus infections. This year has been much better because of teaching online. The patient underwent lab tests and procedures which included allergy test: positive on 01Feb2021, weight: 128-129 lbs on 01Feb2021.The outcome of mouth swelled, tongue swelled, roof of mouth was swelling and numb and tingling was recovered on unspecified date and outcome of rest other events was unknown. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
31 2021-06-19 eye pain Awoken throughout the night with extreme body aches (Eye sockets, neck, hip sockets--worst )and migr... Read more
Awoken throughout the night with extreme body aches (Eye sockets, neck, hip sockets--worst )and migraine. Around 5:30am I took two extra strength Tylenol to no avail. I proceeded with chills, shakes, fever, cold hands and feet, sweating, exhaustion, and loss of appetite. These expected symptoms subsided/ were manageable at approximately 5:30 pm. At 7pm, I began having trouble climbing the stairs and had intense pain in the center of my chest. I could breath alright (I was NOT light headed), but couldn't alleviate the chest pain. I went to sleep at 8:30pm in hopes that it would dissipate. **(Did not go to hospital because we are military, my husband is TDY and I had no one to watch our children. This is not to downgrade the fear or intensity of the pain. I have a very high pain threshold- this was awful.)** Saturday (Day 3 after vaccine) no chest pain, but began spotting (my period is very regular and tracked diligently-I'm not meant to start for another 8 days), still had a very sore neck/ migraine, and swollen/painful lymph nodes in my armpit ( on the vaccine side). Sunday (day 3 after vaccine) still spotting heavily, painful lymph nodes, and migraine.
31 2021-06-20 mouth numbness Pt returned to pharmacy counter after 15 minutes to pick up her vaccination card, and at that time s... Read more
Pt returned to pharmacy counter after 15 minutes to pick up her vaccination card, and at that time showed us the rash on her arm. Pt was asked to remain in the pharmacy for an additional 15 minutes for observation. Pt stayed a total of 40 minutes after vaccination. Pt had no difficulty breathing, and rash/itchiness did not spread beyond affected limb. Pt was instructed to take diphenhydramine 50mg and to seek immediate medical assistance if symptoms worsened or had any difficulty breathing. Followed up with pt a day later, and pt's rash has resolved, but stated that she has slight numbness on tip and sides of tongue. Pt advised to follow up with primary healthcare provider
31 2021-06-21 taste impairment Metallic taste; This is a spontaneous report from a contactable consumer (patient) from COVAES. This... Read more
Metallic taste; This is a spontaneous report from a contactable consumer (patient) from COVAES. This non-pregnant 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 21May2021 at 11:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraine, fibromyalgia, Hashimoto's, depression, essential tremor, anxiety, and post-traumatic stress disorder (PTSD), all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in four weeks. Concomitant medications included levothyroxine, duloxetine, ibuprofen, and vitamin D, all from unknown dates for unknown indications. The patient previously received codeine from an unknown date for an unknown indication and experienced drug allergy; and a flu shot on an unknown date for immunisation and experienced vaccine allergy. On21May2021 the patient experienced metallic taste 20 minutes after she received her shot; and reported it didn't go away regardless of what she did. No treatment was received for the events. The clinical outcome of metallic taste was not recovered. It was also reported that the patient had not been tested for COVID-19 since vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
31 2021-06-21 taste impairment burning sensation in back of my throat; all I taste is saline; This is a spontaneous report from a c... Read more
burning sensation in back of my throat; all I taste is saline; This is a spontaneous report from a contactable consumer (patient). This 31-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0171) via an unspecified route of administration on 22May2021 (at the age of 31-years-old) as a single dose in the left deltoid for COVID-19 immunization. Medial history included polycystic ovary syndrome (PCOS). Concomitant medications included ethinyl estradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA) from an unknown date for birth control. The patient previously received dose 1 of BNT162B2 on 01May2021 for COVID-19 immunization and experienced sore arm for a week and tired. On 22May2021, the patient experienced a burning sensation in the back of her throat and all she tasted was saline. She wanted to know if she had any allergic reaction. The patient did not receive any treatment for the events. The outcomes of burning sensation and tasted saline were unknown. No follow-up attempts are needed. No further information is expected.
31 2021-06-22 mouth tingling Tingling in mouth, itchiness all over. Next several days, itchiness, hives over full body, pinpoint ... Read more
Tingling in mouth, itchiness all over. Next several days, itchiness, hives over full body, pinpoint red dots on skin all over, tingling in mouth. Arm pain, headaches, body aches, swollen lymph nodes in right armpit, fatigue. Heavier periods since first Covid 19 vaccine dose in April.
31 2021-06-23 ear swelling After the second vaccine the patient had a large swollen area starting at the level of her left ear ... Read more
After the second vaccine the patient had a large swollen area starting at the level of her left ear extending down the face to about the jaw
31 2021-06-24 sensitivity to light On Thursday June 24th at approximately 6:00am I woke up drenched in sweat, took my temp, it was 100.... Read more
On Thursday June 24th at approximately 6:00am I woke up drenched in sweat, took my temp, it was 100.7, muscle aches, severe fatigue, headache, sore arm where injection took place. I took a bath and started feeling better around 10pm Thursday evening, no fever, only a little fatigue, muscle ache, headache, chills. On Friday June 25th around 4am I started feeling feverish again, took temp, it was 100.4. I feel very fatigued again, muscle aches got better, headache got worse now sensitive to light.
31 2021-06-25 smell distorsion, taste impairment I am having bitter taste in mouth. Almost everything tastes and smells like some weird metal to me. ... Read more
I am having bitter taste in mouth. Almost everything tastes and smells like some weird metal to me. I thought it will be ok in few days but its been over a month and its still the same. Even an ice cream tastes bitter and horrible.
31 2021-06-28 ringing in ears, deafness unilateral 1st Dose: 05/21/21; 2nd Dose: 06/11/21 After first dose, experienced ringing in left ear on and ... Read more
1st Dose: 05/21/21; 2nd Dose: 06/11/21 After first dose, experienced ringing in left ear on and off and reduced hearing ability. After second dose, developed constant ringing in ear and hearing loss in left ear (tinnitus) at 9 pm on 6/13/21 which has not gone away since. Visited family care practitioner on 06/18/21; confirmed no visible blockage in left ear and referred to ENT doctor. Appointment and hearing test scheduled for 07/22/21. As instructed, taking Flonase (2x/nostril, 2 x/day) until 7/22 appointment. If any change so far, problem has gotten worse. No issue w/ right ear. Note: Experienced trauma on left side of head resulting from car accident in 2011, but no recurring problems as a result.
31 2021-06-29 taste impairment metallic taste in mouth; fever; exhaustion; headache; nausea; body ache; This is a spontaneous repor... Read more
metallic taste in mouth; fever; exhaustion; headache; nausea; body ache; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 20Mar2021 at 10:30(at the age of 31 years old) as a single dose for COVID-19 immunisation. Medical history included Multiple chronic illnesses - do not fit in the space allotted. Concomitant medications were reported as Yes, they do not fit in the space provided. Any allergies to medications, food, or other products was reported as Many allergies - I cannot fit them in the space allotted. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 26Feb2021 at 16:45 as a single dose for COVID-19 immunisation. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. since the vaccination, the patient was tested for COVID-19. On 20Mar2021 at 23:30, the patient experienced metallic taste in mouth and otherwise, textbook reaction - fever, exhaustion, headache, nausea, head and body aches. The patient did not receive treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the metallic taste, fever, exhaustion, headache, nausea, head and body aches was not recovered. No follow-up attempts are needed. No further information is expected.
31 2021-06-29 eye swelling Rash to face and left arm; swollen lymph node to right arm; febrile and flushed; febrile and flushed... Read more
Rash to face and left arm; swollen lymph node to right arm; febrile and flushed; febrile and flushed; sweats and chills; sweats and chills; nausea; vomiting; diarrhea; muscle and joint pain; muscle and joint pain; severe headache; generalized weakness; swollen eyes; insomnia; This is a spontaneous report from a non-contactable other hcp (Nurse). A 31-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via intramuscular, administered in arm right on 07Jan2021 14:15 (age of vaccination: 31-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient previously received first dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient tested covid post vaccination. The patient has non known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), naproxen (NAPROXEN) and paracetamol (TYLENOL). The patient experienced rash to face and left arm, swollen lymph node to right arm, febrile and flushed, sweats and chills, nausea vomiting diarrhea, muscle and joint pain, severe headache, generalized weakness, swollen eyes, insomnia on 07Jan2021 at 07:00 PM. Treatment received otc medications, prednisone rescue regimen and muscle relaxants. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. The outcome of all the events was recovered with lasting effects on unspecified date. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.
31 2021-06-29 ringing in ears Patient stated she previously received the Moderna COVID-19 vaccine and had a severe reaction consis... Read more
Patient stated she previously received the Moderna COVID-19 vaccine and had a severe reaction consisting of tinnitus. She also stated she discussed the side effect with her PCP, and would like to receive the Pfizer COVID-19 vaccine to complete her vaccine series.
31 2021-06-30 swollen gums, taste disorder, swollen tongue, mouth tingling, mouth pain, mouth swelling, lip swelling, lip pain, burning mouth syndrome, painful gums ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and g... Read more
ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and gums; Painful to eat; limited taste (similar to having seriously burned your tongue and mouth); tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; itchy throat; This is a spontaneous report from a contactable other hcp (patient). A 31-years-old non-pregnant female patient received second dose of BNT162B2 (CONMINTARY, Solution for injection, Lot No: EL3249 and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 22Jan2021 at 10:00 AM (at the age of 31 years), as a single dose for covid-19 immunisation. The patient medical history included very minor latex irritation from an unknown date and unknown if ongoing. The patient concomitant medications received within 2 weeks included prenatal vitamin. Historical vaccine included first dose of BNT162B2 (CONMINTARY, Solution for injection, Lot No: EL1284 and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 30Dec2020, as a single dose for covid-19 immunisation. The most recent covid-19 vaccine was administered in hospital. The patient didn't receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for covid-19. On 22Jan2021, 1-5 hours after injection, the patient had experienced tingling, painful and swollen mouth, gums, cheeks, tongue and lips on, itchy throat. On 23Jan2021, the patient had experienced ulcerated tongue, cheeks and gums on, painful to eat, limited taste. There was no treatment received for adverse events. Outcome of the events were recovered. The reporter seriousness was reported as Non-serious. Follow-up attempts are completed. No further information is expected.
31 2021-07-02 ear discomfort vertigo happening every time she is standing up; left arm where she got the injection, it feels very... Read more
vertigo happening every time she is standing up; left arm where she got the injection, it feels very heavy; not feeling good; left ear is stuffed up; cough; is POTS one of the regular side effects; blood pressure is low; her heart rate jumps up from laying down to sitting or standing up; lot of phlegm and cough; congestion/very stuffy; feeling run down/feeling tired/extremely tired/feeling tired; little fever; Sinus infection; Dehydration; Dizziness; Headache; This is a spontaneous report from a contactable pharmacist. A 31 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, in Deltoid Left (at the age of 31 years old) on 30May2021 (between 12 and 3 early afternoon) (Batch/Lot Number: EW0153; Expiration Date: 31Jul2021) as DOSE 1, 0.3 mL, single for covid-19 immunization. Medical history included von Willebrand s disease from an unknown date and unknown if ongoing (diagnosed age 9 or 10 at the time suffering from dizziness, feeling not good, and she had anxiety problems, the patient had multiple tests they found a blood disorder). No other vaccines were given within 4 weeks. Historical Vaccine includes INFLUENZA VACCINE in 2017 and 2018 at the Age: 27 and 28 sick for 3 to 4 days with flu like symptoms, and the patient had that twice. There were no concomitant medications. The patient experienced dizziness (disability) on 30May2021, dehydration (medically significant) on Jun2021, feeling run down/feeling tired/extremely tired (disability) on 03Jun2021, vertigo happening every time she is standing up (disability, medically significant) on an unspecified. headache (non-serious) on 30May2021 to 30May2021, little fever (non-serious) on 03Jun2021, not feeling good (non-serious) on an unspecified date, sinus infection (non-serious) on Jun2021, left ear is stuffed up (non-serious) on an unspecified date, left arm where she got the injection, it feels very heavy (medical sig) on an unspecified date, cough (non-serious) on an unspecified date, is pots one of the regular side effects (non-serious) on an unspecified date, blood pressure is low (non-serious) on an unspecified date, her heart rate jumps up from laying down to sitting or standing up (non-serious) on an unspecified date, congestion/very stuffy (non-serious) on 03Jun2021, lot of phlegm and cough (non-serious) on an unspecified date. The patient underwent lab tests and procedures which included Investigations: On an unspecified date in Jun2021 Bloodwork for (anemia, Red blood cell analysis, Thyroid function test normal) all results was normal (Investigations: the patient had 3 sets of bloodwork, the last yesterday, and they could not find anything, they ruled out like thyroid, anemia, RBCs, they said was normal); On an unspecified date Blood test revealed severely dehydrated; On an unspecified date blood pressure is low. Therapeutic measures were taken as a result of dizziness dehydration, Vertigo happening every time she is standing up and, sinus infection. The clinical course was reported as follows patient received the first dose on 30May2021, and the only side effect was a little bit of Dizziness and headache started 30 to 45 minutes after the first dose, and it went away, and in 3 days the patient was fine. Headache was there that day, and has not been a problem since. Tuesday (date unspecified) she experienced dizziness, she was off keel a little. She had a little fever and was feeling run down. Fever started 03Jun2021 about 4 days after the vaccine, and stayed probably about a day or two and went away, and has not been a problem since. Feeling run down 03Jun2021, started 4 days after the vaccine, the patient couldn t tell if it was the vaccine, or from her trying to do too much, and the patient didnt rest, but it seems it could be the vaccine compounded from not resting. By Friday, Saturday, and Sunday, she was feeling tired, a whole 9 days after the vaccine was given, the first dose, she was feeling run down, but that was about it, she was able to do normal chores, like running around, and by Monday, which puts at now 10 days after the vaccine, she is not feeling good, and very extremely tired, and dizziness, the dizziness was setting in and is aggravated ever since; however she was diagnosed 3 days later with a sinus infection and dehydration Jun2021 (Patient was told she could be dehydrated because of the sinus infection.), she was given an IV at the hospital (later clarified in the ER). She was given IV fluid, did bloodwork and said she was severely dehydrated, the patient was told to go home and hydrate, and cut out, caffeine as the patient thought it made dizziness worse, That same night, she had a bout of dizziness take over her, and the patient was taken to the ER again, for a second time, 6-7 days after the first ER visit, and during that visit they said she is no longer dehydrated, but they wanted her to take something for the dizziness, said Antivert (later clarified as meclizine) would work, so they gave it in the ER, and it seemed to make it better, but it didnt go away, and the patient was discharged and all her vitals were good, she had no dehydration, was sent home with meclizine and the next morning the patient went to the PCP and the PCP said she was dehydrated, and to follow up again, and on Monday, that was 3 days, she was not dehydrated it was also reported and the patient called her PCP about 5 to 6 days ago, and her bloodwork is ok. She was on 10 days of antibiotics, and she ended up in the ER again because of vertigo happening every time she is standing up, so basically, the patient is still having dizziness and complaining about not being able to do work, Dizziness happens when the patient sits or stands; caller would say this is disabling, as the patient cannot do daily functions, ironing or whatever. She is feeling too dizzy and afraid to fall. Caller stated the patient had a sinus infection and was given Augmentin. Caller reported the patient saw an ENT. There was a lot of phlegm and cough, and it subsided within 2 to 3 days, but the dizziness is still there the whole time and tiredness, the dizziness remains. Since 10 days, the patient had dizziness, then a bout of vertigo, and is still run down, patient is lying in bed for 2 weeks now, when she gets up, she is spinning, and the patient has been able to go to her PCP, but is very slow due to dizziness. The dizziness seems to not be going away, and the patient s ear is very stuffy like if someone put a cotton ball in it, the stuffiness is constantly there, and today she said, the arm where the shot was given, for 2 weeks it was very heavy, no pain, but very heavy, she has sensations and 3 days today she has extreme heaviness in the arm from the shoulder to the elbow. Caller states Arm heaviness is serious, not disabling, but the patient said the best way to say, is like someone pulling her arm down, but no pain, dizziness when she stands or sits, and caller was reading about side effects, she was thinking there were a few instances of POTS, and the patient saw a cardiologist today, saw her PCP yesterday. The patient postponed the second dose. Pharmacist inquired if POTS one of the regular side effects, and can she get better, also, since the patient has not had the second vaccine, will the effect, will the first dose wean over 3 weeks, caller thought the first dose would wean so the patient would feel better. The clinical outcome of the event dizziness, fatigue was not recovered, headache recovered 30May2021, fever, lot of phlegm and cough recovered Jun2021. Verbatim event relatedness per reporter: Pfizer COVID vaccine: little fever Related, feeling run down Related and left arm where she got the injection, it feels very heavy Related. Follow up attempts are possible. Further information is expected.; Sender's Comments: The causal association of reported serious events in relation to suspected drug BNT162B2 cannot be totally excluded based on event occurrence and timing of drug administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
31 2021-07-03 lip swelling Urticaria (on back of neck, bilateral arms), upper lip swelling and scratchy sensation in throat. Co... Read more
Urticaria (on back of neck, bilateral arms), upper lip swelling and scratchy sensation in throat. Consistent with anaphylaxis.
31 2021-07-05 ear swelling My first Pfizer Vaccine was on April 19, 2021 and my second vaccination was taken on May 10, 2021. ... Read more
My first Pfizer Vaccine was on April 19, 2021 and my second vaccination was taken on May 10, 2021. Four days after the second vaccination, I started having ear problems, dizziness and vertigo whilst working in front of my computer in the office and outside of work related duties.
31 2021-07-05 lip swelling mild lip swelling (both doses)
31 2021-07-06 drooping eyelid, eye twitching, drooling, eye disorder Within 5 minutes I had uncontrollable spasms, I can't control my eyes, extreme fatigue, loss of memo... Read more
Within 5 minutes I had uncontrollable spasms, I can't control my eyes, extreme fatigue, loss of memory and time. Sharp shooting pains from injection site to all the tips of my fingers across my chest up to my skull. I have a lot generalized pain on my left side. now that a month has gone by it my left side gets worse, a drool, my left eye droops and shakes. My whole face and arm will be paralyzed. I get facial ticks. I have overwhelming fatigue and confusion. I have chest pain. I can't read at all, and I can't process what I hear at times. I have nausea and vomiting.
31 2021-07-06 mouth discomfort, mouth tingling I started to feel a deep tingling and burning sensation on my upper lip; Entire body is in hives/it ... Read more
I started to feel a deep tingling and burning sensation on my upper lip; Entire body is in hives/it is hives all over her body; she really wants to itch herself and she is trying not to/ lot of itching; her body feels like she has chicken pox; rash/On her legs it's like patches.; lips still burning; This is a spontaneous report received from a contactable other healthcare professional (Dental receptionist reported for self). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0179), first dose via an unspecified route of administration, administered in left arm on 04May2021 at 18:00 (at the age of 31-year-old), as a single for COVID-19 immunisation administered at other facility. Medical history included asthma, two mini strokes (it's been 2 or 3 years, she does not have that information), chicken pox, Patient stated she is allergic to all to medications. Her doctor does not prescribed medications to her at all. This included acetaminophen, ibuprofen, aspirin and all NSAID medications. There were no concomitant medications. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. It was reported that, on 04May2021, patient went to (withheld) to get her first dose of the Pfizer vaccine. Patient's vaccination was scheduled for 04May2021 at 18:00. Patient's allergist recommended that she wait another 15 minutes just to be sure. She had nothing in her bloodstream when she arrived because she was allergic to all over-the-counter drugs, including acetmetaphine, ibuprofen, naproxen, aspirin, and other NSAIDs. Since she had asthma and wanted to make sure this vaccine was right for her, she saw both her PCP and an allergist specialist before getting the vaccine. Suggested to her that it would be useful to her. The shot was administered to her on her left arm, on 04May2021, and shortly after receiving the vaccine on 04May2021 at 18:15, she started to feel a deep tingling and burning sensation on her upper lip, which spread progressively across the bottom of her lower lip. She told the on-duty nurse. She said it had nothing to do with the vaccine. She then led her to the seating room, instructing another nurse present to keep an eye on patient, for the first. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the event tingling lips and burning sensation. She stated she also called in to Pfizer the same day after sending it online because she missed that it said it would be taking like a week. She did this on the 22May2021. She was at her general doctor's office so she can give him an understanding of what happened. She has only taken her first dose and she was not comfortable taking her second dose after this reaction. Patient said she was not sure if all of that information was shared on her previous report. Verified that patient was referring to the Pfizer Covid-19 vaccine. She wanted to know if there was a way, she can get a call back, because the doctor may be coming in soon and she may have to disconnect the phone call. She gave a brief summary as to what she did. She did not know what she was supposed to do. She was calling to see when the follow-up was and what was her next step. She stated her body feels like she has chicken pox. She has already had chicken pox before so it's just like her entire body was in hives. She cannot wear jeans anymore, because if she wears anything tight fitting, her body goes into hives. Constant hive mode. She was sitting in her doctor's office and she really wants to itch herself and she was trying not to. At night it was ten times worse. She wanted information, but she really wants to report want her incident was. She has never been in this situation before. Her allergist even wrote out a prescription saying that nothing would happen to her. So, she needs to do a follow up with him. It has been a month in her system. She knew it was going to take like 3 weeks for the vaccine to run its course, so she gave it time. She took the vaccine on 04May2021 and it is now 06Jun2021. So, it has been a month in her system, and it was still not going away. She wants to know if there is a way, she can reverse this. She wants to know if she should go and take Moderna. Should she take Johnson and Johnson. She did not know what to do at this point. She definitely wants the vaccine in her body, but she did not want to be allergic to it. She would like a call back on Tuesday if possible. She does not have the lot number for the vaccine with her to provide. She had it on the paper and she did that online. She does not have NDC or expiration with her right now either. The rash happened right away on 04May2021. There was a lot of itching and her lips are still burning. The itching was everywhere, not just one place. It feels like she was not quite sure, if it's shingles or chicken pox. It is constantly itching. She has taken Benadryl, Zyrtec and Allegra and they have all stopped working. Nothing was working. Patient does not have medications with her at time of call and cannot provide, NDC, Lot and Expiry. She tried them a week apart, for like a week each because it has been 3 weeks. Benadryl worked for 3 days and then it stopped. Then she tried Zyrtec, which worked for a day and then nothing. It worked for like a couple hours. Allegra worked for maybe 3 hours and then it stopped. If she wears tight jeans and a t-shirt on top and then if she takes them off a couple hours later, it was hives all over her body. On her legs it's like patches. She does not know how to stop this itching. Since the issue started, it was the same. there was no improvement. Normally when she was allergic to medications, she takes Benadryl because that helps her soothe it down and within a day it was gone out of her system, but now that the vaccine was in her system and none of these medications are working. She did not know what to do. It was reported that there is a product complaint to report. She was at her general doctor's office so she can give him an understanding of what happened. She has only taken her first dose and she is not comfortable taking her second dose. Complaint regarding Benadryl, Zyrtec, and Allegra: It is constantly itching. She has taken Benadryl, Zyrtec and Allegra and they have all stopped working. Nothing was working. She tried them a week apart. Benadryl worked for 3 days and then it stopped. Then she tried Zyrtec, which worked for a day and then nothing. It worked for like a couple hours. Allegra worked for maybe 3 hours and then it stopped. Allegra and Zyrtec were the small count bottles and Benadryl was a box of 8, 9 or 10. Patient did not have medications with her at time of call and cannot provide, NDC, Lot and Expiry. Is a sample of the product available to be returned, if requested reported as yes for all products and packaging sealed and intact was reported as yes for all products. She did not know what she was supposed to do. She was calling to see when the follow-up was and what was her next step. She wanted to know if there was a way, she can reverse this on her. She wanted to know if she should go and take Moderna or not and should she take Johnson and Johnson. She did not know what to do at this point. She would like a call back on Tuesday if possible. patient notified to call back on specific day was not guaranteed. Patient was given with Covid-19 phone number to call back. The outcome of the events was reported as not resolved and for rash outcome was reported as unknown. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
31 2021-07-07 eye floaters Feeling of faintness and chest pain resulted in going to the emergency room. It was determined to be... Read more
Feeling of faintness and chest pain resulted in going to the emergency room. It was determined to be inflammation within the chest and I was given a steroid for 6 days. Since this initial event, I have had issues with balance and eye floaters. I continue to have chest pains and feelings of numbness and pain in my left arm.
31 2021-07-11 mouth tingling Lips, face and neck went tingly; Lips, face and neck went tingly; They became semi-numb (sort of fee... Read more
Lips, face and neck went tingly; Lips, face and neck went tingly; They became semi-numb (sort of feeling like when your feet fall asleep); This is a spontaneous report from a contactable consumer who is reported for herself that. A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: 9265 Expiry date UNKNOWN) via an unspecified route of administration in the left arm on 08Feb2021 16:00 (age at vaccination was 31-year-old) as a SINGLE DOSE for COVID-19 immunisation and first dose was administered in left arm on 18Jan2021 16:30 (Lot number 3249 Expiry date UNKNOWN) as a SINGLE DOSE for COVID-19 immunisation. The patient had allergy to Codeine. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and post vaccination. The patient had not been tested for COVID-19. Concomitant medications included in two weeks was sertraline hydrochloride (ZOLOFT) The patient did not receive any other vaccines in four weeks. On 08Feb2021 17:15 patient's Lips, face and neck went tingly and became semi-numb (sort of feeling like when your feet fall asleep). No treatment received for the events. The outcome of the events was recovering. Follow-up (14May2021): Follow-up attempts completed. No further information expected
31 2021-07-12 dry eye, bloodshot eyes Itching, dryness, eye redness and swelling of cornea in the left eye.
31 2021-07-12 sensitivity to light Injection site pain; muscle pain; joint pain; tingling; headache; sensitivity to light and sound; ch... Read more
Injection site pain; muscle pain; joint pain; tingling; headache; sensitivity to light and sound; chest tightness; body aches; This is a spontaneous report from a non-contactable consumer, patient. A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204), via an unspecified administrated in the left arm on 27Mar2021 at 10:45 hours as a single dose for COVID-19 immunisation (at the age of 31-years-old). Medical history not provided. Concomitant medications included metformin (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) for an unknown indication. Previously patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified administrated in the left arm on 4March2021 as a single dose for COVID-19 immunisation (at the age of 31-years-old). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient was not tested for COVID-19. On 27March2021, at 12:45 hours patient experienced injection site pain, muscle pain, joint pain, tingling, headache, sensitivity to light and sound, chest tightness, body aches. Prior to vaccination, the patient was not diagnosed with COVID-19. Therapeutic measures were not taken as a result of the event. Clinical outcome of the Injection site pain, muscle pain, joint pain, tingling, headache, sensitivity to light and sound, chest tightness, body aches was recovering at the time of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
31 2021-07-14 eye movement disorder About 11 hours after vaccine, woke up at around 4:45AM. Got up to go pee. Peed. Stood up and took a ... Read more
About 11 hours after vaccine, woke up at around 4:45AM. Got up to go pee. Peed. Stood up and took a few steps. Felt like I was going to pass out so laid down on ground. Seconds later, passed out for about 10 seconds and eyes rolled back (according to my husband). Woke up and started to lift head and passed out again with seizure-like activity. About an hour later, did ECG and CT and was monitored at hospital. CT was normal. ECG said Nonspecific Intraventricular conduction delay 115. Emergency department thought it was vasovagal syncope possibly related to the Covid-19 vaccine. (Note: this was my second dose of Pfizer vaccine. First dose was given to me in another country on June 19, 2021: Comirnaty - EU/1/20/1528, 1119349007 SARS-CoV-2 mRNA vaccine, Biontech Manufacturing GmbH. Did not have any side effects after first dose).
31 2021-07-20 oropharyngeal discomfort Heart palpitations the night of the vaccine shot. Chest tightness for 10 after the shot. I contacted... Read more
Heart palpitations the night of the vaccine shot. Chest tightness for 10 after the shot. I contacted my PCP and she had me come in for assessment. Did and ecg and determined that right now, it was normal. Said that I should track my palpitations and tightness and would give me a cardio referral if I wanted. On 4/30 had chest discomfort and a bubble feeling in my throat so I went into urgent care. Did another ecg and found a sinus arrhythmia.
31 2021-07-20 mouth tingling My face started to get numb, my throat started to get scratchy, cheeks got red, lip tingle
31 2021-07-22 eye irritation, eye twitching Patient began to feel dizziness, right eye irritated, eye closed involuntarily, right jaw cheek bega... Read more
Patient began to feel dizziness, right eye irritated, eye closed involuntarily, right jaw cheek began to feel numb. Pt drank a glass of water and a cookie in case of low blood sugar. This did not resolve the dizziness. Pt stated that she had similar symptoms four months ago and was taken the ER where diagnosed with Bells Palsy. She stated afterwards that she has had migraine headaches and had taken an ibuprofen at 10:30am with breakfast. She had started having migraine the night before administration of 2ndose of Pfizer vaccine. We observed for 35 minutes with symptoms continuing to increase. We took the patient to the ER to be evaluated and treated on her own. Pt did not have transportation to arrive at ER room and no Urgent Care in area.
31 2021-07-26 loss of smell, loss of taste Second dose received Thursday 7/22, Thursday night had had fever of 102, Friday afternoon diarrhea b... Read more
Second dose received Thursday 7/22, Thursday night had had fever of 102, Friday afternoon diarrhea began (ended Saturday evening), Friday evening began feeling fatigued and had fever of 101 as well as loss of appetite. Friday night I had congestion which is ongoing as of Tuesday 7/27 with minor improvements as well as a minor cough with some phlegm. Tuesday 7/27 around mid day I realized I have lost both taste and smell. I scheduled a visit through Doctor and the doctor advised that it could potentially be allergy related and recommended an allergy medication as well as anti inflammatory medication but to also follow up with a covid test just to be sure it isn't covid.
31 2021-07-27 lip swelling, swelling around the eyes I started having random lip swelling, eye puffiness, and hives every few days just under 3 months af... Read more
I started having random lip swelling, eye puffiness, and hives every few days just under 3 months after receiving 2nd dose of Pfizer vaccine. Symptoms worsened over time. Saw allergist who performed blood tests and I am now diagnosed with Chronic Spontaneous Urticaria with Angioedema. I now take a daily antihistamine. I am told this disease may last more than 5 years since I have angioedema as well.
31 2021-07-28 eye discomfort, oropharyngeal discomfort, visual impairment Headache; Hands felt swollen but were not; Pressure in throat; could see black spots; felt cross eye... Read more
Headache; Hands felt swollen but were not; Pressure in throat; could see black spots; felt cross eyed; injection site sore; body aches all over; Shortness of breath; Pressure in the chest; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-years-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 28Apr2021 around 16:20 ( 31-years-old at the time of vaccination), (Batch/Lot Number: EW0170; Expiration Date: 31Aug2021) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. Medical history included narcolepsy from 2013 and ongoing, coma from 2013 to an unknown date (had a car accident was in a coma), narcoleptic from 2013 to an unknown date had brain trauma. She became narcoleptic as a result. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for narcolepsy, start and stop date were not reported. Historical vaccine included bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 (Batch/Lot Number: ER8733) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Patient stated that she was calling regarding the Pfizer Covid vaccine. She had her second dose the day before yesterday. Was reading about some side effects and allergic reactions and just wanted to verify if what she read was correct. Was she having a reaction, an allergic reaction? Nothing that she read said that it was. On Wednesday, she got her second dosage, the injection site did not hurt. She had stayed for an hour because it was documented about what happened last time. This time, it was the same thing. She had the shortness of breath. It felt like pressure, like when working out and you feel exhausted. She felt it in her throat, not in her chest or back. They told her to take Tylenol and she went home. She did and she went home, took a nap and when she woke up her hands felt like they were swollen, and they were not. She had trouble breathing again. This time, something different happened. She felt cross eyed, like when one eye feels like it is on top of the other. Her vision was like one on top of the other. She could see black spots but had no headache. It lasted about 2 hours. She kept drinking water and it started decreasing and she went to sleep. She woke up this morning and the injection site was a little sore. There was no rash, and her vision was fine. Her breathing and everything were good. She called to see if she was having an allergic reaction. She did not see anything that said that. Hands felt swollen but were not. This started after the second shot. It felt like when part of her body feels pressure. She had someone check and they were not swollen. It felt like veins popping out. There was no redness or pain. The veins were very pronounced. It lasted about 4 hours. It went away and didn't come back. Patient stated that she had, Body aches all over was after the second dose it lasted 46 hours. Pressure in the chest was the second time, it occurred right after the nurse pulled out the needle. It lasted for about 12 hours, went away, and came back. It has stopped and she is not experiencing it anymore. Injection site sore was Started about 7:00 this morning. Did not feel this the first time. She confirmed this was the only thing she was feeling at this time. If she did not move her arm, she does not feel it. However, once she moves her arm, she feels it. Headache was lasted 17 hours then started increasing. She feels about the same. It happened over night and the physician's office was closed. She didn't feel comfortable going to the hospital. Patient received just the Tylenol. She also takes Adderall on a normal basis because she was narcoleptic. The clinical outcome of the events injection site sore was not recovered, all other events was unknown. No follow up attempts are needed; No further information is expected.
32 2020-12-31 eye strain Headache, Fever, Body Aches, Nausea, Chills, Asthenopia, fatigue for 36 hrs
32 2021-01-05 dry mouth Mild headache and light headed for around 2 hours. Dry mouth for around 4 hours. I took 500mg Napr... Read more
Mild headache and light headed for around 2 hours. Dry mouth for around 4 hours. I took 500mg Naproxen for the headache, and drink water for the dry mouth
32 2021-01-05 dry mouth Lightheaded, dizzy, nausea, flushed, dry mouth began about 10 min after vaccination
32 2021-01-05 lip swelling, ear swelling 12/24 headache, low grade fever, chills took advil. 12/29 2:30am severe reaction of itching aggres... Read more
12/24 headache, low grade fever, chills took advil. 12/29 2:30am severe reaction of itching aggressively from scalp to toes, broke out in red hives, tachycardic Itchy throat, swollen, ears and lips.
32 2021-01-05 ringing in ears, hearing loss, deafness unilateral One day after vaccine (12/25/20) patient woke up with ringing in her ears, echoing, and diminished h... Read more
One day after vaccine (12/25/20) patient woke up with ringing in her ears, echoing, and diminished hearing. Ringing subsided 12/26/20 but diminished hearing continued. Seen by ENT 12/30/20 and diagnosed with hearing loss, right, with restricted hearing, left.
32 2021-01-06 loss of taste I had reduced taste no fever, no muscle aches no chills, no cough or shortness of breath. I decided ... Read more
I had reduced taste no fever, no muscle aches no chills, no cough or shortness of breath. I decided to go to the ER to get a covid test because I was scheduled to work that day and I did want to make sure I was not positive due to the loss of taste but if I was not working that day I would not have got medical care. I did have loss of taste for some more days but after that it was resolved (around 3 days).
32 2021-01-06 feeling of choking Pt. c/o of tingling and tightness in the back of the throat and a warm feeling over her body. Alert ... Read more
Pt. c/o of tingling and tightness in the back of the throat and a warm feeling over her body. Alert and oriented Narrative: Pt. c/o of tingling and tightness in the back of the throat and a warm feeling over her body. 126/77, P 81, R 18 O2 sat at 96.1% at 1420; @ 1435 106/67, P. 65, R 16, O2 sat 99%; @ 1444 BP 115/63, P 67, R 17, O2 sat 100%.Symptoms resolved ay 1435 and denied any c/o. D/c'd in stable vs.
32 2021-01-07 loss of smell, loss of taste On the 31st I developed COVID. Runny nose, back ache, and covid symptoms. I still can't smell nor ... Read more
On the 31st I developed COVID. Runny nose, back ache, and covid symptoms. I still can't smell nor taste.
32 2021-01-07 eye pain Approximately 13-14 hours after 2nd vaccine dose, developed generalized fatigue, myalgias, chills, a... Read more
Approximately 13-14 hours after 2nd vaccine dose, developed generalized fatigue, myalgias, chills, and low grade fever (100.6F oral temp). Symptoms largely resolved within 24 hours; however, had persistent eye soreness (pain with lateral movement) through 72 hours post-vaccination for which additional evaluation was sought.
32 2021-01-08 loss of taste On 12-26-2020 I started to have fever, chilis, loss of taste and headaches. I got diagnosed with Cov... Read more
On 12-26-2020 I started to have fever, chilis, loss of taste and headaches. I got diagnosed with Covid on 12-29-2020. I habe lingering of shortness of breath.
32 2021-01-08 eye swelling Myalgia & Fever Narrative: left upper arm edema and pain, bilateral eye swelling
32 2021-01-08 lip swelling Woke up next morning with very swollen lips/angioedema
32 2021-01-08 lip swelling 1352 - Pt reports upper lip swelling, unable to see on visual assessment, BP-141/92, 100% on RA, T ... Read more
1352 - Pt reports upper lip swelling, unable to see on visual assessment, BP-141/92, 100% on RA, T - 98.1, HR - 91, RR - 16. Given 25 mg of oral benadryl per this RN per vaccination clinic standing order. 1403 - Pt reports feeling no change from initial report but does note "some finger tingling". 92% on RA, HR - 88. 1410 - Discussed taking a 2nd 25mg dose with patient. Will hold at this time, she states "my hands normally feel puffy when this gets worse but they feel normal now". Pt reports upper lip swelling feels "puffy" but unchanged from initial report. 1418 - Pt reports upper lip swelling increased, BP - 140/85, HR - 80, RR 16, 100% on RA, 25mg of oral benadryl given. 1423 - Pt reports upper lip "puffiness" with slight improvement, new c/o upper back itchiness, no rash or hives visualized on assessment 1428 - Pt reports improvement to feeling of "puffiness", back itchiness remains the same, and pt "feels sleepy" 1438 - Pt reports resolution of upper lip swelling and says "It feels like when I came in", slight back itchiness still present 1448 - Pt reassessed 30 min post 2nd dose of benadryl, pt reports complete resolution of all symptoms, BP - 135/79, T - 98.2, RR - 14, HR - 78, 100% on RA Discussed transportation with patient prior to providing 2nd dose of Benadryl, Pt home via private vehicle with mother (driver) and partner. Educated patient to call nurse on call number with any further concerns or if symptoms resume.
32 2021-01-08 feeling of choking After 10 minutes, throat began to become numb/tingly/itchy. Then at 20 minutes, I started to have di... Read more
After 10 minutes, throat began to become numb/tingly/itchy. Then at 20 minutes, I started to have difficulty swallowing. I told the medical provider who was there in the observation room. My vitals were stable. They sent me to the ER to be watched and observed for 6 hours. my throat's numb/itchiness/tingling went away, but remained difficult to swallow until the next morning. My vitals stayed stable.
32 2021-01-10 mouth tingling The patient received Pfizer's COVID vaccine at 12:22pm. They returned to the pharmacy at 1:20pm repo... Read more
The patient received Pfizer's COVID vaccine at 12:22pm. They returned to the pharmacy at 1:20pm reporting she couldn't clear her throat and her tongue felt "tingly". They estimate this started around 12:55pm. EMS was contacted once the patient returned to the pharmacy. The patient was monitored. No medications were administered. EMS arrived at 1:29pm and the patient left with them.
32 2021-01-11 loss of taste, loss of smell I started running a fever and body ache after vaccine. On 27th loss taste and smell.
32 2021-01-11 loss of taste, loss of smell Lost taste and smell 2 days post vaccine along with a positive cover test 3 days post vaccine
32 2021-01-11 eye swelling, lip swelling, mouth numbness within 1 hr post-vaccine on 1/7 I had a mild headache that resolved with Tylenol. At about 12 hours ... Read more
within 1 hr post-vaccine on 1/7 I had a mild headache that resolved with Tylenol. At about 12 hours post-vaccine I developed nausea, fever (100.4) and chills and secondary to this had poor sleep. The next day I took scheduled alternating Tylenol & ibuprofen during the day and then overnight 1 episode of chills that woke me up. no events Saturday or Sunday. Then Monday 1/11 in the early morning I started to develop a rash on my b/l elbow and right foot 3rd toe. I applied mometasone topical cream to these locations. while at work the rash extended down both forearms then by 5pm it was on both hips and extending along both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the itching woke me up. I repeated Benadryl 25mg at 8am. The rash seems to be getting better on the arms but then by noon I had a new breakout on my neck and face. I took Benadryl 50mg at 1pm. The rash continued to have a rapid progression over the next hour and resulted in angioedema with my throat swelling, lips puffed and numb and eye swelling. I was injected with an epi pen and sent to the ED where I received PO prednisone, famotidine, and Benadryl. The face/neck rash then greatly improved and I was sent home on prednisone 40mg daily for 3 days.
32 2021-01-11 bloodshot eyes, eye swelling Swelling and redness under eyes around tear trough dermal fillers noticed about 19 hours after recei... Read more
Swelling and redness under eyes around tear trough dermal fillers noticed about 19 hours after receiving 2nd dose of the vaccine. Taking antihistamines at home, haven?t sought treatment from a provider at this time.
32 2021-01-11 feeling of choking, mouth tingling Throat and tongue tingling, hot flash
32 2021-01-12 loss of smell, loss of taste Estimated due date: 06/14/2021 On 12/27 I woke up with headaches, I had headaches until the 30th. On... Read more
Estimated due date: 06/14/2021 On 12/27 I woke up with headaches, I had headaches until the 30th. On 12/28 my son was tested positive for covid. I tested negative on the 20th and 30th. My symptoms started getting worse (loss of taste and smell) and 01/06 I tested positive. 01/11 at 5PM I had my second dose. I had some body aches and fever (101.5F). chills, sweats and Tylenol and it was not making a difference. Last night around 8PM my temp was to 100.8F and today I woke up and temperature normal and body aches much better.
32 2021-01-12 eye itchiness About 24 hours after the vaccine injection felt like something stuck in throat and chest hurt. Progr... Read more
About 24 hours after the vaccine injection felt like something stuck in throat and chest hurt. Progressed in 30 minutes to pain in chest and head, swallowing painful, whole body and eyes itching and felt irritable. Symptoms continued for 24 hours.
32 2021-01-12 painful gums tachycardia (140 bpm); Fever above 101; myalgia; joint pain right arm, joint pain and swelling to ri... Read more
tachycardia (140 bpm); Fever above 101; myalgia; joint pain right arm, joint pain and swelling to right wrist; joint pain and swelling to right wrist; swollen lymph node on right side of body; weakness; skin redness and burning sensation; skin redness and burning sensation; tremors; gum pain; fatigue; migraine; sweating; back pain; first dose of bnt162b2 on 18Dec2020 at 16:00, second dose on 04Jan2021 at 08:00 AM; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELU140), via an unspecified route of administration on 04Jan2021 at 08:00 AM on Right arm at single dose for COVID-19 immunization. The patient medical history included had known allergies with Penicillin, bees and wasp. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol, retinol (VITAMIN A); colecalciferol (VITAMIN D); calcium phosphate dibasic, phytomenadione (VITAMIN K); cyanocobalamin (VITAMIN B12); levothyroxine, liothyronine (NP THYROID). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), via an unspecified route of administration on 18Dec2020 at 16:00 on Right arm at single dose for COVID-19 immunization. The patient experienced fever above 101, tachycardia (140 bpm), myalgia, joint pain right arm, joint pain and swelling to right wrist, swollen lymph node on right side of body, weakness, skin redness and burning sensation, tremors, gum pain, migraine, fatigue, sweating and back pain, all on 04Jan2021 at 20:00, events were resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had not been tested for COVID-19. It was unknown if any treatment was received for events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
32 2021-01-12 hearing loss, vision blurred covid injection #1 on 12/23/20. 5 days later on 12/28/2021 woke up with nausea and diarrhea. Had vas... Read more
covid injection #1 on 12/23/20. 5 days later on 12/28/2021 woke up with nausea and diarrhea. Had vasovagal symptoms of lightheaded, blurred vision, hearing changes, and weakness of legs while standing. was in healthcare setting working at the time. Initial vitals 87/60, drank apple juice and rested, BP came up 15 min later to 100/75. At approx. 7pm on 12/28/2020 developed chills which turned into sweats with myalgia's and arthralgia's, took 1g Tylenol, at 9pm fever still 101.7*F. Fever lasted approx 8 hours. Nausea resolved. Diarrhea lasted about 36 hours.
32 2021-01-12 eye discomfort Headache began the next morning and had been returning daily with pain and pressure behind the eyes.... Read more
Headache began the next morning and had been returning daily with pain and pressure behind the eyes. Some sinus inflammation but clear discharge. Swollen lymph node on left side of neck started 1/10 with minor pain.
32 2021-01-12 mouth tingling About 15 minutes after receiving the second dose of the Pfizer vaccine at Clinic, patient began comp... Read more
About 15 minutes after receiving the second dose of the Pfizer vaccine at Clinic, patient began complaining that she was dizzy and nauseated. Patient was seated on the exam table at this time, and was helped to lay down on the exam table. Vitals were obtained by RN. Patient began complaining of tingling of her lips while vitals were being obtained at 1110. PA was notified and brought to the room to evaluate patient. Patient denied having any difficulty breathing or swallowing, was not experiencing any itching of the mouth, tongue or throat, and did not notice anything else unusual, patient was still dizzy and nauseated. Patient stated that she had a similar reaction to the first dose of the Pfizer COVID vaccine, where the symptoms resolved within about an hour. Nursing staff and PA stayed with patient during the duration of her observation. Patients vitals ranged betwen pulse ox = 98-99%, pulse = 97-106 bpm, B/P = 114-121/80-89 mm hg. Patient also complained of some tingling around the lower jaw at 1147. Patient was observed for 1 hour and 26 minutes after vaccination was received. Symptoms gradually resolved, upon discharge patients lightheadedness had resolved, and the tingling around the lips and jaw were mostly gone. Patient still was not having any shortness of breath, chest pain, trouble breathing, rash or hives, swelling/tingling/numbess of the tongue, mouth, or throat. Discharge instructions were provided by PA, including when to seek further care at the ER or to call 911. Patient felt comfortable driving herself home and left at 1214. About two hours later, pt presented to ED. Pt endorsed throat tingling, lightheaded, nausea. She also stated that while the reaction post Dose 1 and Dose 2 were similar, the reaction after Dose 2 was much more severe. Assessed for transient Bell's Palsy presentation but determined unlikely as no facial asymmetry or deficits were appreciated. RR 24, other vitals WNL. Pt observed for about 1.5 hours before discharging home with instructions to call ED should condition worsen.
32 2021-01-12 mouth tingling Patient c/o a tingling in lips and rash over arm. Patient taken immediately to ER to be seen.
32 2021-01-12 vision blurred, hearing loss Numbness and tingling down left arm into fingers (worst is pinkie and ring fingers), dizziness with ... Read more
Numbness and tingling down left arm into fingers (worst is pinkie and ring fingers), dizziness with blurred vision, hearing sounded like underwater, felt like I had trouble talking. Notified nurse that gave me vaccine, several other nurses came over and helped me into recliner and laid me back and took vitals. Vitals are stable. I quickly began to feel better (within 5 minutes of being reclined). Still had the numbness and tingling. I laid in recliner for 30 minutes, then sat up for 10 minutes before leaving. I drank water and ate 2 rice krispies while in recliner. Numbness and tingling improved, but lingered throughout the day and was gone next morning.
32 2021-01-13 mouth tingling within 15 minutes developed dysphagia, tongue tingling. : transferred to ED : Observed for 4 hrs an... Read more
within 15 minutes developed dysphagia, tongue tingling. : transferred to ED : Observed for 4 hrs and d'cd to home
32 2021-01-13 mouth tingling Mild tingling on the right side of her mouth and face that started shortly after receiving the vacci... Read more
Mild tingling on the right side of her mouth and face that started shortly after receiving the vaccination. Symptoms were less intense and lasted for a shorter period of time than after the first injection.
32 2021-01-13 visual impairment Employee called the nurse line reported adverse reaction to second covid vaccine. Caller received va... Read more
Employee called the nurse line reported adverse reaction to second covid vaccine. Caller received vaccine at 1330 and started to have vision changes bilaterally of halos around vision lasting for 10 minutes at a time and a slight headache
32 2021-01-14 dry mouth Continued dizziness, dry mouth, sore throat, nausea, headache, vertigo, with intermittent sweating a... Read more
Continued dizziness, dry mouth, sore throat, nausea, headache, vertigo, with intermittent sweating and hot flashes over 48 hrs after vaccination. Improvement with Tylenol 1000mg.
32 2021-01-14 lip swelling Hot injection site; sore arm; swollen lip; nausea; This is a spontaneous report from a contactable ... Read more
Hot injection site; sore arm; swollen lip; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 08Jan2021 07:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history reported as none. The patient's concomitant medications were not reported. The patient's historic vaccine included Other Pfizer vaccine on 18Dec2020. The patient experienced hot injection site, sore arm, swollen lip, nausea on 09Jan2021 15:00. Therapeutic measures were taken as a result of events included Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering. Information on Lot/ Batch number has been requested.
32 2021-01-14 mouth discomfort Immediate headache and severe nausea, that evening around 12:30am I woke up to my stomach and mouth ... Read more
Immediate headache and severe nausea, that evening around 12:30am I woke up to my stomach and mouth feeling as if they were on fire. The nausea continued for two days but lightened each day. Very fatigued feeling, pale in color and arms keep falling asleep randomly for 3 days now.
32 2021-01-14 enlarged tonsils Following vaccine administration, patient c/o "tonsils feeling swollen". VS were checked. BP was ele... Read more
Following vaccine administration, patient c/o "tonsils feeling swollen". VS were checked. BP was elevated. ERT was called. Patient was assessed. Plan determined to monitor patient in clinic for additional 30 minutes. If no change, patient able to leave. Recheck of vitals shows lower BP, patient stated she is feeling better and less of a feeling in her throat. She decided to leave. She was provided instructions to return to the ED if symptoms got worse.
32 2021-01-14 vision blurred At approximately 5 minutes into the 15-minute monitoring window, I became severely dizzy, flush, and... Read more
At approximately 5 minutes into the 15-minute monitoring window, I became severely dizzy, flush, and light-headed while simultaneously experiencing right-sided tingling, the altered sensation from my forehead to collarbone (right side only). At approximately four hours post-vaccination my right eye had mild blurriness to my vision. The vision resolved within a few hours but the altered right-sided sensations continued for 6 days, gradually improving. The lightheadedness and dizziness that required cool clothes and elevated feet resolved enough to stand after 30 minutes.
32 2021-01-16 taste impairment Metallic taste in mouth that started about five minutes post vaccination; persisted for about two ho... Read more
Metallic taste in mouth that started about five minutes post vaccination; persisted for about two hours post vaccination. Facial and hand swelling started two hours post vaccination, persisted for 24 hours after; itchy throat started at two hours after, persisted for about eight hours after vaccination. 18 hours post vaccination, severe headache and moderate nausea set in, both lasted for another 18 hours (36 hours post vaccination). Mild myalgias and nausea at 48 hours pat vaccination.
32 2021-01-16 eye swelling This was the second dose given 2 weeks after the first dose. Itchy rash and hives and swollen eyes 2... Read more
This was the second dose given 2 weeks after the first dose. Itchy rash and hives and swollen eyes 2 days after vaccine.
32 2021-01-17 eye pain Left side facial numbness, intermittent eye and cheek pain, at times entire left side numbness, craw... Read more
Left side facial numbness, intermittent eye and cheek pain, at times entire left side numbness, crawling feeling to left side intermittently
32 2021-01-17 lip swelling, swollen tongue, swollen lips tightening of my chest and throat, wheezing, swelling and irritation in back of tongue and lips, ras... Read more
tightening of my chest and throat, wheezing, swelling and irritation in back of tongue and lips, rash/ skin bloching on face and chest bilaterally, injection site swelling and redness.
32 2021-01-18 ear pain, ear swelling, ear itchiness headache; earache; cough; chills; entire body aches/soreness; itchy red swollen rash on palms of han... Read more
headache; earache; cough; chills; entire body aches/soreness; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; itchy red swollen rash on palms of hands; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; right ear swelling/itching; right ear swelling/itching; This is a spontaneous report from a contactable Other HCP (patient). This 32-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 at single dose (lot number: e13246) for covid-19 immunisation. Medical history included PCOS, HSV2, ADHD, anxiety, depression. Concomitant medications included atenolol (NORTELOL), spironolactone, valaciclovir (VALACYCLOVIR), bupropion. The patient previously received erythromycin and experienced allergies, received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) at left arm on 14Dec2020 04:00 P.M for covid-19 immunisation. The patient experienced headache, earache, cough, chills, entire body aches/soreness, fatigue, Right arm pit tender/sore, itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching on 09Jan2021 12:00 A.M. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was recovering.
32 2021-01-18 eye swelling on 1/17/21 I was at home watching a movie around 6:00pm started itching and eyes started swelling wh... Read more
on 1/17/21 I was at home watching a movie around 6:00pm started itching and eyes started swelling when to the bathroom to look and I had hives all over my upper body. I have not changed in anything in my house or tried any new food. I took some Pepcid and a cold shower. in about an hour the itching stopped but I was still red. went to bed then when I woke up the next morning my hands was so swollen I couldn't move my fingers and they was numb, itching and hurting all at the same time. so i went to the clinic. they gave me a steroid shot, Benadryl, Pepcid and Claritin. my hands started to go down some before i left the clinic. not i have to take all the meds the next 3 days. still on 1/19/21 @ 6:00am my face started to flush before i took my meds.
32 2021-01-18 lip swelling, ear swelling 12/24 headache, low grade fever, chills took advil 12/29 2:30am severe reactionof itching agressiv... Read more
12/24 headache, low grade fever, chills took advil 12/29 2:30am severe reactionof itching agressively from scalp to toes, broke out in Red Bumpy Hives, Heart RateFaster, Itchy throat, swollen, ears and lips
32 2021-01-18 thirst, oropharyngeal discomfort I started feeling like my throat is scratchy and it looks like really red; I started feeling like my... Read more
I started feeling like my throat is scratchy and it looks like really red; I started feeling like my throat is scratchy and it looks like really red; I got really thirsty; I do feel like discomfort on the front of my throat; I can feel the swelling in the throat; This is a spontaneous report from a contactable consumer. A 32-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration from 08Jan2021 to 08Jan2021 at a single dose for an unspecified indication. Medical history was not reported. Concomitant medication included ascorbic acid, (VITAMIN C), ergocalciferol (VITAMIN D) and retinol palmitate (VITAMIN A). It was reported by the patient that she started feeling like her throat is scratchy and she looked at it in the mirror and it looks like really red. She got really thirsty so she started drinking a lot of water and she had some ice that she is chewing on. She felt like discomfort on the front of her throat and swelling; all occurred in 08Jan2021. The outcome of the events was unknown. Information about batch number has been requested.
32 2021-01-18 ringing in ears Quick onset of Left sided numbness/tingling turning into facial paralysis, unable to close eye, head... Read more
Quick onset of Left sided numbness/tingling turning into facial paralysis, unable to close eye, headache, ear ringing, etc.
32 2021-01-19 mouth itchiness itchy throat, lump in throat, itchy mouth, trouble swallowing
32 2021-01-19 oropharyngeal discomfort Patient reports that she did not have any issues after the first Covid19 Pfizer vaccine but 5 minute... Read more
Patient reports that she did not have any issues after the first Covid19 Pfizer vaccine but 5 minute after her second dose she felt like it was hard to swallow. She attributed this to excitement from completing vaccine series and finished her 15 minute wait time. She went home but it became harder to swallow and she felt like her chest was "heavy" and she became short of breathe walking up stairs. She took fexofenadine 180mg and cetirizine 10mg and filed a report with the CDC. Her symptoms resolved and she slept. The morning after her vaccine she felt fine and went for a 6 mile run. She called vaccine clinic to see what kind of follow up she needed to completed and was asked to contact PCP and employee health. She presented to PCP that day (day after second vaccine) who reported ongoing symptoms of moderate chest tightness and some throat discomfort. Given prescription for Medrol dose pack, albuterol inhaler, and EpiPen and instructions on when to present for care.
32 2021-01-19 taste disorder, burning mouth syndrome, tongue discomfort, lip pain 1/13/2021 2nd vaccination 1/18/2021 9/930 am noticed sense of taste was off; SOUR. my tongue feels r... Read more
1/13/2021 2nd vaccination 1/18/2021 9/930 am noticed sense of taste was off; SOUR. my tongue feels really dry, painful and it feels like i burnt it like from drinking something HOT. sometimes travels to the lips, sometimes goes away. Presently, still experiencing. COVID test per employee health. NO blisters. *normal vaccine symptoms after 1s shot; very tired.
32 2021-01-20 loss of smell I received the first dose of vaccine on 12/17/20 with no symptoms initially other than soreness at i... Read more
I received the first dose of vaccine on 12/17/20 with no symptoms initially other than soreness at injection site. 4-5 days post vaccine I began to have mild sinus drainage, headaches, and backaches that I attributed to allergies, stress, and sinus issues. On the evening of 12/23/20, I had lost my sense of smell completely and had diminished taste. I was tested for COVID-19 around 0830 the next morning on 12/24/20 and was positive for the virus. That day and the 7-8 days that followed I was extremely fatigued with muscle aches. I continued to participate in the V-safe surveys and made note that I was having these symptoms likely because I was positive for COVID-19 (as of 12/24/20). The CDC called and I relayed this information to them and it was decided that a report was not necessary. After my second dose of vaccine on 01/07/21, I received another call from the CDC and it was recommended that I do file a report so data could be collected on those who have tested positive for COVID-19 after the initial vaccine. I had no significant symptoms after my second vaccine and have presumably fully recovered from the virus to date.
32 2021-01-21 mouth numbness, mouth tingling Tingles in lip and numbness and the next day body aches, couldn?t get up from bed and had to call in... Read more
Tingles in lip and numbness and the next day body aches, couldn?t get up from bed and had to call into work. As of today mild body aches.
32 2021-01-21 mouth tingling Immediately following vaccine, I have tingling in my left hand. 20 minutes after vaccine, I started ... Read more
Immediately following vaccine, I have tingling in my left hand. 20 minutes after vaccine, I started to experience tingling in my neck on the left side which then progressed to tingling of the left side of my mouth. 25 minutes after vaccine, the left side of my mouth and my left nare became numb. My left hand still tingled but I lost feeling in my ring and pinky finger on the same hand. All symptoms resolved on their own by 3 hours post vaccine without the need for medical intervention.
32 2021-01-21 mouth tingling Was given vaccine at a clinic with EMS present. Approximately 5 minutes after the injection she sai... Read more
Was given vaccine at a clinic with EMS present. Approximately 5 minutes after the injection she said she felt lightheaded/dizzy first, some dizziness, with slight tingling of the tongue. Said her legs felt tingling, hot and hands shook. She said throat felt slightly tight. EMS was on sight and they administered her Solumedrol and Benadryl IM. She was never given an epi injection. They monitored her HR and O2 Sats. After she felt symptoms were resolved she did leave the clinic on her own accord. She returned to her work even though she was advised to go home and rest per medical personal.
32 2021-01-21 swelling of eyelid Four days after she received the 1st dose, she developed a swollen eye lid that resolved on its own... Read more
Four days after she received the 1st dose, she developed a swollen eye lid that resolved on its own. She really didn?t think anything of it and did not report it to anyone or take any medication for it. On 1/12/2021 she received the 2nd dose. On day 7 of her vaccine she developed hives on her lower extremities. She took Benadryl that day and they improved, but did not got away. On day 8 the hives reapproved and she took a dose of Claritin and that got her through working. On day 9 (yesterday) the hives have migrated from just her lower extremities to her arms and shoulders. She took both Zyrtec and Benadryl yesterday, but she is not getting any relief.
32 2021-01-21 swelling of eyelid I had the first vaccine with no adverse side effects and had no adverse side effects right after the... Read more
I had the first vaccine with no adverse side effects and had no adverse side effects right after the second dose but approximately 2 or 3 days after I had facial swelling about my eye lids. Then, the evening of 1/20, I developed hives all over both legs. They were still there the next morning and I took Benadryl and later loratadine and they eventually went down. Later in the evening on 1/21 they came back so I took a Zyrtec and the next morning they were worse and were on my legs and arms and shoulders. I called employee health and the doctor directed me to take Zyrtec twice daily and also to take a Pepcid daily. At this point in the afternoon on 1/22, I still have the hives but they seem to be slightly improving as the day goes on.
32 2021-01-22 pain in jaw brief period of feeling extreme heaviness in shoulders and arms, tingling hands/feet. Followed by mu... Read more
brief period of feeling extreme heaviness in shoulders and arms, tingling hands/feet. Followed by muscle aches, general body tension, chills, mild headache. Also ear/jaw pain (possibly related to prior sinus infection)
32 2021-01-23 mouth numbness Immediately experienced tingling in my arm up to my neck. When I left, I noticed my mouth and tongue... Read more
Immediately experienced tingling in my arm up to my neck. When I left, I noticed my mouth and tongue were numb. My throat was tighter than usual. I took Benadryl when I got home and my symptoms were improved. I had a sore throat later that evening.
32 2021-01-24 mouth numbness 10:00am Patient returned from walking to car post-vaccination, stating that her mouth began to feel ... Read more
10:00am Patient returned from walking to car post-vaccination, stating that her mouth began to feel numb and she felt a bit lightheaded. Patient brought to back area to semi-reclining chair, BP 128/77, 72HRT. States she ate breakfast, felt a bit anxious. Allergic to amoxicillin which causes rash and vomiting. Takes only prenatal vits; denies any medical condition. Numb lips, mouth, tongue, breathing fine according to patient. 10:17am Numbness spread to hands, nose, upper face, dull headache; states her breathing is fine, feels lump in back of throat however. Given 25mg liquid Benadryl oral, tolerated well. BP 116/69, HRT 67, 10:35am symptoms improving, denies feeling lightheaded, stood for 1 minute, stated she felt fine, patient discharged to self, ambulatory, husband aware and at home.
32 2021-01-25 mouth numbness 3:45 pm - received vaccine. 4:17 pm - Experienced tongue numbness, throat tightness, facial swelling... Read more
3:45 pm - received vaccine. 4:17 pm - Experienced tongue numbness, throat tightness, facial swelling, chest tightness, SOB. Given epinephrine 5:15 pm - Given Benadryl in the ED. And observed for 4 hours without adverse reaction.
32 2021-01-25 mouth numbness Patient with history of hives to Flu shot previously along with other allergies noted. Instructed to... Read more
Patient with history of hives to Flu shot previously along with other allergies noted. Instructed to stay 30 mins. for monitoring. Around the 30 min. mark, patient reports tightness and discomfort around chest area and tongue numbness. Upon assessment, occipital lymph nodes were symmetrical. Bilateral feet kept elevated, water given. Vitals @4:17pm - BP 114/76, HR 118, Temp 37.3, O2 100%. Patient reports more chest discomfort and throat tightness. Epi pen 0.3mg administered at 4:19pm. Repeat vitals @4:22pm - BP 141/69, HR 123, O2 99%, Temp 37.3. Patient states some chest relief after Epi. Transported to ED for future monitoring and evaluation.
32 2021-01-26 mouth tingling tingling tongue 50mg benadryl given observation
32 2021-01-27 mouth tingling Numbness, paresthesias, burning pain of bilateral legs, left is worse than right. Numbness, paresthe... Read more
Numbness, paresthesias, burning pain of bilateral legs, left is worse than right. Numbness, paresthesias, burning pain, Deep aching pain of left upper extremity, cold sensation of left arm and left leg. Numbness of the face, paresthesias of the lips, objectively decreased light touch everywhere, but worse in all the areas mentioned.
32 2021-01-28 lip swelling severe cough; left nostril swelling; generalized hives throughout abdomen and hips; lower lip swolle... Read more
severe cough; left nostril swelling; generalized hives throughout abdomen and hips; lower lip swollen/upper lip on left side swelling; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 07Jan2021 at 13:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history included allergies to dust, pollen, and dog and cat dander. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on 17Dec2020 at 13:00 on the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Jan2021 at 21:00 (five days after second vaccine dose, for clarification), the patient had lower lip swollen. Second episode occurred (on an unspecified date) with severe cough, upper lip on left side swelling, left nostril swelling, and generalized hives throughout abdomen and hips. The patient took Benadryl for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering. Information about lot/batch number has been requested.
32 2021-01-29 mouth numbness, swollen tongue, mouth tingling Flushed face and feeling around 30 minutes after injection, 45 minutes wide spread rash over arms, l... Read more
Flushed face and feeling around 30 minutes after injection, 45 minutes wide spread rash over arms, legs and face; tightness in jaw, tongue and face swelling with numbness and tingling.
32 2021-01-29 lip swelling Patient came in for COVID vaccine she was in good spirits. After her vaccine, she started off with a... Read more
Patient came in for COVID vaccine she was in good spirits. After her vaccine, she started off with a small cough that started to increase. She started to cough more at which time I requested my RN to come and evaluate her and Monitor her while I reached out to our ER which is attached. We moved the patient to the sleep lab while waiting for the ER to come up. Patient started complaining she felt that her throat was closing. Her O2 was stable at 98/99. Her HR was over 100 bpm. When the ER team came up and put her in a wheel chair her upper lip was swelling and her arm was blotchy. Patient did come up a few hours later to schedule her 2nd dose vaccine after she received a high dose IV Benadryl and Pepcid. She is going to speak to her PCP about this reaction and let me us know if she can take the 2nd dose.
32 2021-01-29 mouth tingling Pt developed tingling around mouth and cheeks as well as itching in on the right Shin. Treatment: C... Read more
Pt developed tingling around mouth and cheeks as well as itching in on the right Shin. Treatment: Cetirizine 10 mg PO and an addition 30 minute observation. The pt felt better after the additional wait time, vitals signs stable She was released home.
32 2021-01-29 swelling of eyelid, eye swelling Acute swelling of left eye, lower left eyelid.
32 2021-01-30 mouth lesion, mouth itchiness After first dose, arm soreness lasting 3 days, headache lasting an hour. After around 5 days, I thou... Read more
After first dose, arm soreness lasting 3 days, headache lasting an hour. After around 5 days, I thought it was stress related, but I started to have itchiness on the roof of my mouth at the back. There is a kind of rashy area in the back of my mouth, mostly on the roof. It itches a lot and it makes my throat hurt when I attempt to scratch it. I have had to use chloraseptic spray and numbing cough drops to ease the itch and pain. Also, I have been experiencing shortness of breath. I attributed it to Chronic Bronchitis, but it feels different and is not constant. I didn't make the connection of mild allergic reaction until I received my second dose. I received my second dose on 01/29/2021. I was experiencing flu-like symptoms on 1/30, and am not experiencing the same symptoms as of 1/31. I am, however, still experiencing the mouth rash and itching, and mild shortness of breath.
32 2021-01-31 loss of smell Arm began to hurt within 4hrs after receiving my 1st dose. Within 48hrs I was congested. Three days... Read more
Arm began to hurt within 4hrs after receiving my 1st dose. Within 48hrs I was congested. Three days later noticed loss of smell. During breakfast.
32 2021-01-31 sensitivity to light Per patient received COVID 19 vaccine on 1/27/2021 and by 1/29/2021 started having symptoms: Pressur... Read more
Per patient received COVID 19 vaccine on 1/27/2021 and by 1/29/2021 started having symptoms: Pressure headache all over head, sensitivity to light, nausea, vomiting and decrease in appetite. Per Client was able to take extra strength Tylenol and Ibuprofen with minimal relief. Per Client was not until Sunday, 1/31/2021 that all symptoms had resolved. Per Client will plan to follow up with PCP prior to receiving second dose of COVID 19 vaccine.
32 2021-01-31 thirst, taste impairment Metallic taste in mouth, insatiable thirst
32 2021-01-31 tongue discomfort, mouth tingling Tingling and tightness to tongue and R side of face
32 2021-02-01 mouth tingling lips tingling, shortness of breath
32 2021-02-01 mouth tingling Tingling around mouth and tongue. Body aches the whole next day.
32 2021-02-02 mouth itchiness Within five minutes of injection mild headache. Within seven minutes of injection lightheadedness de... Read more
Within five minutes of injection mild headache. Within seven minutes of injection lightheadedness developed. At eight minutes severe burning within chest. This initial onset symptoms did resolve within five minutes, however recurred times for over the course of 20 minutes.. After 30 minutes post injection, right forearm and lower left abdomen with blotchy erythema. Throughout the rest of the day roof of mouth and throat mildly pruritic. Overnight severe diaphoresis. Following day mild Tonsillar lymphadenopathy, hoarseness of voice, sore throat, chest tightness.
32 2021-02-03 oropharyngeal discomfort Patient got her Covid-19 vaccine around 8:00 AM on 1/19/21. Around 10:00 AM patient presented at u... Read more
Patient got her Covid-19 vaccine around 8:00 AM on 1/19/21. Around 10:00 AM patient presented at urgent care clinic. Reported red spots on her neck, face and chest. Patient also have throat discomfort, feels like she needs an extra effort to breath. Benadryl 25 mg po given per MD order.
32 2021-02-04 loss of taste, loss of smell Loss of taste and sense of smell for less than 24 hours
32 2021-02-07 mouth itchiness, lip itchiness pt experienced severe itching around her face and on the vaccinated arm, the itching became worse ov... Read more
pt experienced severe itching around her face and on the vaccinated arm, the itching became worse over ten minutes and progressed to the inside of her mouth around her lips, she was given 25mg of benedryl and the itching resolved within 45 minutes.
32 2021-02-07 vision blurred Delirium; headache; body chills; nausea; strong pressure felt in head and neck; strong pressure felt... Read more
Delirium; headache; body chills; nausea; strong pressure felt in head and neck; strong pressure felt in head and neck; blurred vision; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9261, expiry date not reported) via an unspecified route of administration at left arm, on 22Jan2021 10:45, single dose, for COVID-19 immunization. Medical history included neoplasm malignant and hypersensitivity. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccine in the last four weeks. It was unknown if the patient has COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medication included alprazolam (XANAX) and doxycycline hyclate. On 22Jan2021 14:00, the patient experienced delirium, headache, body chills, nausea, strong pressure felt in head and neck, and blurred vision. Outcome of the events was not recovered.
32 2021-02-09 ringing in ears Static/ringing in the ears 24/7. Have noticed it for two days now.
32 2021-02-09 vision blurred /Pt reports, a numb tingling sensation, became diaphoretic, described blurry vision. BP 80/40, pt l... Read more
/Pt reports, a numb tingling sensation, became diaphoretic, described blurry vision. BP 80/40, pt laid down with feet propped up, EMS activated. Pt allowed to rest, regained color and states she feels better. 16:25, patient refused transport to ER via EMS, 16:45 Patient ambulated out of the clinic with out assistance with husband.
32 2021-02-11 mouth tingling, mouth numbness, ear pain Minor Bell's Palsy- Increase in numbness/tingling of the tongue over the past two days. Lips started... Read more
Minor Bell's Palsy- Increase in numbness/tingling of the tongue over the past two days. Lips started to numb today. Pain is increasing in left ear. No noticeable drooping of facial muscles yet, but symptoms may increase in the next 24 hours.
32 2021-02-11 drooling passed out and almost broke her arm; started salivating really bad/it's lot of drool; Heart rate sta... Read more
passed out and almost broke her arm; started salivating really bad/it's lot of drool; Heart rate started pounding; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261, expiration date May2021), via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunisation. Medical history included: Allergy. Concomitant medication included drospirenone, ethinylestradiol (YASMIN) for Birth control, chlorphenamine maleate (PIRITON) for Allergy. The patient was perfectly fine up until about the 3 hours after the vaccine, she started salivating really bad, she was not throwing up or nauseas or anything, it's just that it's lot of drool, like she even had just go over sink as just salivating so much it was weird, and her heart rate started pounding and she passed out and almost broke her arm, so and then she kind of like blacked out and don't remember anything for rest of the evening. The events onset date was on 26Jan2021 08:30. No treatment was received. The outcome of events was recovered in Jan2021.
32 2021-02-13 eye pain Right after: discomfort in elbow, eye sensitivity Next day: sore arm, fever (101.5), body aches, se... Read more
Right after: discomfort in elbow, eye sensitivity Next day: sore arm, fever (101.5), body aches, severe chills. Third day: sore arm, inflamed lymphnode in left side armpit.
32 2021-02-14 ear discomfort, ringing in ears Tinnitus, clogged ears, head pressure starting twenty hours after vaccine and lasting 48 hour. Head ... Read more
Tinnitus, clogged ears, head pressure starting twenty hours after vaccine and lasting 48 hour. Head ache lasting greater than 36hours.
32 2021-02-15 vision blurred Patient received 1st dose of COVID vaccine today 2/16/21 at around 1009 am. Patient complained of d... Read more
Patient received 1st dose of COVID vaccine today 2/16/21 at around 1009 am. Patient complained of dizziness and blurry vision after 30 minutes. Patient stated she is diabetic and has not eaten her meal yet. Patient also stated she was not able to have a good sleep a night ago. Vital signs taken and was stable. Po hydration (water) and hard candy given to patient. Apple juice was also given. Blood sugar taken and is 160 mg/dl. Patient monitored for 30 minutes and was stable after.
32 2021-02-17 eye pain, ear pain 21.5 weeks pregnant, first pregnancy. Due date 6/24/21. Day of injection (Monday): strong deltoid s... Read more
21.5 weeks pregnant, first pregnancy. Due date 6/24/21. Day of injection (Monday): strong deltoid soreness. Day 1 following injection (Tuesday): upset stomach. Far less fetal movements than usual throughout most of the day. Day 2 following injection: sore throat that come on in the evening. Quickly spread into lymph node pain in neck, up through the back of the throat toward the nasal cavity, inner ears and behind the eyes. Fetal movement increased to what has been typical at this stage of pregnancy. Day 3 following injection: sore throat, fatigue that was worse when sitting stationary, dizziness, headache. Pain improved in throat, sinuses and behind eyes in afternoon then returned in the evening.
32 2021-02-18 tongue itchiness 10 minutes post vaccination, patient began feeling a warm sensation under her left cheek and the tip... Read more
10 minutes post vaccination, patient began feeling a warm sensation under her left cheek and the tip of her tongue became itchy. No other signs or symptoms reported or noted. She was offered Benadryl but she stated her symptoms were waning and not worsening. She denies any history of allergies except having hay fever as a child. She denies any PMHX and she is not currently on any prescribed or OTC meds. Her vitals were stable and after 10 mins into observation, her symptoms began to wane. Patient was monitored for 45 mins and was stable prior to leaving the vaccination POD. She was educated on what signs and symptoms to monitor. She was advised to follow up with her PCP and or allergist for further evaluation. Patient was informed her 2 nd dose if cleared by her PCP would have to be in an observation facility with a higher level of care. Patient understood and agreed with the above. Patient does not want to evaluated by local ER facility.
32 2021-02-21 gaze palsy, swollen tongue Lightheaded. Skin was clammy, convulsions started, Epi pen administered, she had tongue swelling, ca... Read more
Lightheaded. Skin was clammy, convulsions started, Epi pen administered, she had tongue swelling, came around then eyes rolled back in head, nausea, blood pressure high.
32 2021-02-22 mouth tingling The evening after obtaining the covid vaccine, I started experiencing mild tingling and numbness ... Read more
The evening after obtaining the covid vaccine, I started experiencing mild tingling and numbness to my left arm, left leg, and left side of my mouth and cheek. The left side if where I received my injection. The numbness and tingling resolved after the first day to my arm and leg, but has continues around the left side if my upper lip. The sensation is only intermittent and can last a few hours. No treatments have been tried.
32 2021-02-22 mouth tingling 1/7 vaccination Within a couple minutes after vaccination, my tongue started to tingle. like pop roc... Read more
1/7 vaccination Within a couple minutes after vaccination, my tongue started to tingle. like pop rocks in mouth. I got extremely nauseous. Within 5 minutes, everything was spinning. Continued progressing. HR 180. Within 10 min, i was in ER. They gave my epi pen but it didn't work right away. They were about to start an epi pen and to knock me out, they gave me Benadryl IV, Pepcid?, and they were 30 seconds from intubating me. My vocal cords; broncho spasms. I slowly started to get better. They monitored me for 7 hours. *Still experiencing, daily, SOB. My voice gets harsh. I run out of breath walking, talking, etc. I use prednisone, 2 inhalers daily; Advere and Rescue inhaler. I also suffer from EXTREME HA since then and am on 2 medications for the HA.
32 2021-02-22 ringing in ears, deafness Sudden ringing in the ear- hearing loss
32 2021-02-22 tongue itchiness Itchiness in tongue and throat. Benadril 25 mg Po/ solumedrol 125mg IV Home: Medrol 4mg PO/ Atorax 2... Read more
Itchiness in tongue and throat. Benadril 25 mg Po/ solumedrol 125mg IV Home: Medrol 4mg PO/ Atorax 25mg.
32 2021-02-24 eye irritation On Sunday, 2/21 both forearms, wrists, and thumbs began swelling and experiencing stiffness, tension... Read more
On Sunday, 2/21 both forearms, wrists, and thumbs began swelling and experiencing stiffness, tension, and pain (6/10) that was both burning/nerve pain and achy muscle pain. Previously, my DeQuervein's had been steadily improving through occupational therapy, home exercise, reduced tech use (scrolling/typing), and splinting. By Tuesday, 2/23, range of motion on the Left hand, wrist, and thumb was reduced to almost 0 and the pain reached an steady 9/10 on both arms. As of writing this, the stiffness, swelling, nerve pain, and tension remain at a level higher than the initial level that drove me to seek out occupational therapy back in January. Basically, I went from being close to being discharged to worse than I started. Overall the left side was worse than the right but both sides were impacted. Occupational therapy (ultrasound, fascial release, and assisted stretching) splinting, stretches, and ice were used as treatments. NSAIDs are contraindicated due to Crohn's disease. As of writing this at 16:04 on Thursday, 2/25 none of this has resolved. Pain is a 7/10 on both sides. Range of motion and ability to complete daily care tasks (e.g. dressing, showering, cooking and eating) is nonexistent to minimal.
32 2021-02-24 mouth numbness, taste impairment, pain in jaw Immediately after getting the vaccine, I noticed a strong metallic taste in my mouth. The metallic t... Read more
Immediately after getting the vaccine, I noticed a strong metallic taste in my mouth. The metallic taste lasted for approximately 5 days, decreasing in strength over time. Within 10-15 minutes of getting the vaccine, parts of my face went partially numb (primarily under my lips and along my right cheek). The numbness was largely improved after 1.5 weeks, but I continue to experience it intermittently 3+ weeks later. I also had severe jaw pain that lasted for about 2 weeks, on and off. Within about an hour of receiving the vaccine, I noticed a small amount of rectal bleeding as well; this resolved within the same day. Beyond that, my symptoms were "normal" -- pain at the injection site, mild nausea and chills on the day of the vaccine. I spoke with 5 different doctors about the facial numbness, and none of them were able to advise me on why that might have happened. My primary care physician recommended against getting the second shot until we have more information about what would cause these side effects.
32 2021-02-24 vision blurred Left became irritates with erythema and had blurred vision which resolved by the following day.
32 2021-02-26 inability to speak 2/26/2021- Trouble regulating body temp, headache, sore throat, loss of voice, slight cough, fatigue... Read more
2/26/2021- Trouble regulating body temp, headache, sore throat, loss of voice, slight cough, fatigue, stuffy nose, runny nose 2/27/2021- trouble regulating body temp, headache, sore throat, bad cough (that causes pain in throat, chest and upper back), stuffy nose, runny nose, aching joints, fatigue
32 2021-03-01 feeling of choking Brief episode of throat tingling. NO other symptoms. No wheeze or stridor on exam. Vital signs P 84... Read more
Brief episode of throat tingling. NO other symptoms. No wheeze or stridor on exam. Vital signs P 84, R18, BP 125/76, RA O2 Sat 99%. Patient observed for 30 min. NO worsening or return of symptoms and discharged from the observation area at the vaccination site.
32 2021-03-04 mouth lesion Day 1: Swelling of throat, raised bumps in throat and mouth - 2 Benadryl immediately and ER visit. G... Read more
Day 1: Swelling of throat, raised bumps in throat and mouth - 2 Benadryl immediately and ER visit. Given 40mg Prednisone at ER. 5 day prescription of Prednisone and Pepcid Day 2: Swelling of throat, raised bumps in throat and mouth, racing heart. ER visit for palpitations and sinus tachycardia. Took daily dose of Prednisone, Pepcid, and 2 Benadryl as needed to help swelling. Day 3 (Today): Swelling of throat, and raised bumps in throat and mouth. Took daily dose of Prednisone and Pepcid. Benadryl as needed to help swelling.
32 2021-03-04 mouth itchiness Face sweeping itchy mouth felt horrible headache migraine
32 2021-03-05 taste disorder Fever, muscle pain, fatigue, redness in face, metallic taste in mouth, soreness
32 2021-03-08 smell distorsion Arm pain, muscle aches, swelling lymph nodes right arm only, headache, change in smell sensitivity v... Read more
Arm pain, muscle aches, swelling lymph nodes right arm only, headache, change in smell sensitivity vs a metallic/chemical smell?-onset with headache 2 hours post vaccine. This also happened with first vaccine but thought was a coincidence.
32 2021-03-09 swelling of eyelid Bilateral swollen eye lids and bruising. Started when I woke up the morning after the vaccine. Mildl... Read more
Bilateral swollen eye lids and bruising. Started when I woke up the morning after the vaccine. Mildly itchy, and sore. Swelling went down within 8 hours, bruising went away next day. The following day the skin on my eye lids were very dry, craking/flaking , sore and itching. Applied lotion and resolved on its own.
32 2021-03-09 swollen tongue 13:49: Pfzier Vaccine administered to Left Deltoid 13:55: patient complained of tongue "thickening" ... Read more
13:49: Pfzier Vaccine administered to Left Deltoid 13:55: patient complained of tongue "thickening" 13:56: patient complained of shortness of breath and concerned with taking Benadryl 13:58: patient complained of drowsiness. 911 called 14:00: patient complained of chest pain BP 135/98, P104, PO2 96 14:03: BP 125/100 P 94 PO2 92 14:05: PT states I cant lift my legs 14:06: PT tolerated sips of water. Benadryl 25 mg PO given BP 122/86 P98 PO2 94
32 2021-03-09 thirst felt dizzy; hip pain/extreme muscular and joint pain; nauseat; pale; Insomnia; extremely thirsty but... Read more
felt dizzy; hip pain/extreme muscular and joint pain; nauseat; pale; Insomnia; extremely thirsty but not wanting water; extreme muscular and joint pain; This is a spontaneous report from a contactable nurse (patient) reported that a 32-year-old female patient (non-pregnant) received BNT162B2 (COVID 19, brand: Pfizer, lot unknown reason was Unable to locate or read the details) via an unspecified route of administration on 09Feb2021 at 13:15 on Right arm for Covid-19 immunization. Patient medical history was not reported. The patient received other unknown vaccines within 4 weeks prior to the COVID vaccine on 19Jan2021 on Left arm. Concomitant medications were not reported. Patient previously had allergies to medications, food, or other products: Tramadol. Covid test post vaccination (covid test type post vaccination was Nasal Swab). Covid test name post vaccination was Aeon, covid test date was 04Feb2021 and Covid test result was negative. The most recent COVID-19 vaccine was administered in Nursing Home/Senior Living Facility. It was reported that, on 09Feb2021 at 14:30, after injection 1 hour she felt dizzy and had hip pain, nauseat and pale. Insomnia, extreme muscular and joint pain. On a scale of 1-10, with 10 being the worst that evening after injection 2, that night while trying to sleep. Around 13.5 hours after injection the pain was about a 5 more uncomfortable then anything. 23 hours from injection pain at a 10. Mpap helpful with headache Advil effective for all pain to make it tolerable, cyclobenzaprine slightly effective. Have no eaten since last night, extremely thirsty but not wanting water on 09Feb2021 at 14:30. No seriousness criteria was reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 with Test Aeon. Outcome of events was unknown. Information on the lot/batch number has been requested.
32 2021-03-10 double vision I received the vaccine on Friday, February 26th, 2021, around 10:20am. I was fine throughout the da... Read more
I received the vaccine on Friday, February 26th, 2021, around 10:20am. I was fine throughout the day. I was also fine all day on Saturday, February 27th, 2021. Sunday, February 28th, 2021 at 1:30am, I woke up from sleep with double vision, dizziness, and lightheadedness. I went to use my bathroom, and began to feel week. I was still very lightheaded, and weak. I felt as though I was going to faint. My ears started to feel really warm, and I then vomited. I started feeling lightheaded and weak once again, and then suddenly had diarrhea. I was so dizzy, but managed to head to my bed to sleep. Every single day since, I have been dizzy and losing my balance. I wake up, walk around, and sleep dizzy. Then on Friday, March 5th, 2021 I developed a large lump directly under my armpit. I could not take the dizziness any longer and I went to the ER on Monday, March 8th. I was then diagnosed with vertigo and told that I most likely had lymphodenopathy. Till this day, I am still having dizziness and will be seeing an ENT doctor. I also still have the lump under my armpit. My next dose is, March 19th, 2021.
32 2021-03-10 vision blurred Woke up on Wednesday, 2/24, approx. 12:00am to my entire left arm numb. Woke up and numbness changed... Read more
Woke up on Wednesday, 2/24, approx. 12:00am to my entire left arm numb. Woke up and numbness changed to tingling m. Tingling began to move up arm into neck and upper back then mid back. Then into left side of face and teeth. (No paralysis or Bells palsy - went away in 45 min) By Thursday morning tingling traveled to right right rib cage and feet, settling into hands and feet. Blurry, hard to focus vision. Went to ER on Thursday, 2/25. Not admitted. Discharged with recommendation to do MS workup. Tingling in hands turned to weakness in both hands on Friday. Left wrist and elbow joint pain. Tingling and numbness have persisted in hands and feet. Burning sensation on skin.
32 2021-03-11 swollen tongue 20 min after receiving vaccine reports hives on neck, swelling of tongue and slight difficulty swall... Read more
20 min after receiving vaccine reports hives on neck, swelling of tongue and slight difficulty swallowing. No breathing issues.
32 2021-03-12 mouth tingling, mouth numbness Neck was stiff and back of head/left side jaw/lips were numb and tingly on Thursday, 2/4. Tingly and... Read more
Neck was stiff and back of head/left side jaw/lips were numb and tingly on Thursday, 2/4. Tingly and numbness went away by Friday, 2/5. Neck stiffness and sore back lasted until Tuesday, 2/9. Patient called on-call doctor and her PCP office and was informed to take Benadryl, but that did not help...patient took ibuprofen and reports that it helped reduce symptoms.
32 2021-03-12 vision blurred Patient had Pfizer vaccination around 1:30pm . On drive back to work she started feeling "foggy". ar... Read more
Patient had Pfizer vaccination around 1:30pm . On drive back to work she started feeling "foggy". around 3:00pm and started to get a headache and blurred vision. Patient stated never feeling this way in past. She then began to feel like she was going to pass out. Still had blurred vision and headache. Recommended she go to the ER since she felt like she was going to pass out each time she tried to stand. Patient wen to the ER at 4pm. Patient received shot in the Left arm
32 2021-03-13 loss of smell, loss of taste Tested positive for covid after being vaccinated for greater than 2 weeks. With symptoms of cough, ... Read more
Tested positive for covid after being vaccinated for greater than 2 weeks. With symptoms of cough, chest tightness, headache, stuffy and runny nose, loss of smell and taste
32 2021-03-14 mouth numbness, mouth tingling Client received her first dose of the Pfizer vaccine and during the post-vaccination wait time, she ... Read more
Client received her first dose of the Pfizer vaccine and during the post-vaccination wait time, she complained of tingling, warmth and numbness in her tongue and lips. She denied trouble breathing and any itching or rash. She stated that she has a history of anxiety and is allergic to Zoloft, Ativan and mangoes. Her vital signs were as follows: BP=130/95; Pulse=115. ?911? was immediately called and they responded shortly thereafter with Engine number 305. She was evaluated, advised to take Benadryl if needed and was not transported to the hospital.
32 2021-03-14 vision blurred Immediately after the shot, Pt. felt clammy, had blurred vision and tingling of both hands, then lo... Read more
Immediately after the shot, Pt. felt clammy, had blurred vision and tingling of both hands, then lost consciousness. Fell to floor, hit forehead, left knuckle and left knee. Was assisted to supine position and symptoms improved. (Admits to feeling anxious and not eating enough before the shot and feels that was related to her reaction.) Left facility after observation, and got food before driving self home. Reports soreness and stiff neck from fall injuries. Reports soreness of injected arm and the same "clamminess and sweating" the following morning with fatigue, but without the tingling, lasting only a few hours, then resolved with no further sequelae.
32 2021-03-15 mouth itchiness Pt felt chest tightness immediately after injection. Itching in her mouth 10 mins after vaccine
32 2021-03-16 sensitivity to light Nausea on public transportation while returning home on 3/15. Fever of 99.4-99.8 on 3/16 only. Heada... Read more
Nausea on public transportation while returning home on 3/15. Fever of 99.4-99.8 on 3/16 only. Headache, body ache, elevated period cramps 3/15-3/17. Sense of smell was improved. Continued symptom is headache and light sensitivity and difficulty remaining at work on a computer all day. Pfizer-BioNTech COVID-19 Vaccine EUA.
32 2021-03-16 tongue discomfort 1125- c/o "my tongue feels funny". No obvious swelling noted. BP 154/72, resp 20 Pulse ox 100% Take... Read more
1125- c/o "my tongue feels funny". No obvious swelling noted. BP 154/72, resp 20 Pulse ox 100% Takes pepcid AC daily for "stomach problems". States "my friend made me anxious before my shot" 1130 - Benadryl 25mg po given per standing order. 1140 BP 127/71 pulse 60 resp 18 pulse ox 100% 1145 - denies further c/o tongue feeling funny. 1155 - BP 120/80 Pulse 58 resp 18 pulse 100% 1200 Denies further feeling in tongue. Escorted ambulatory with steady gait to car. Instructed friend to drive.
32 2021-03-18 ear discomfort, ringing in ears Moderately loud tinnitus, especially in left ear. General pressure in ears.
32 2021-03-20 visual impairment AT 5 MINUTES POST VACCINE, PT ADVISED THAT SHE WAS FEELING DIZZY AND HER EYE SIGHT WAS FUNNY. PT PAS... Read more
AT 5 MINUTES POST VACCINE, PT ADVISED THAT SHE WAS FEELING DIZZY AND HER EYE SIGHT WAS FUNNY. PT PASSED OUT, VITALS TAKEN 97/70, HR 76, PT WOKE UP WAS ABLE TO ANSWER PROMPTS. PT TRANSFERRED TO STRETCHER. MONITOREDFOR 57 MINUTES. SYMPTOMS RESOLVED, REPEAT BP 128-62. PTDISCHARGED TO HOME.
32 2021-03-21 swollen tongue EUA Pfizer-BioNtech vaccine patient presented to ER the next day following covid-19 immunization wit... Read more
EUA Pfizer-BioNtech vaccine patient presented to ER the next day following covid-19 immunization with angioedema. She experienced tongue swelling. Her airway is open and and patent and and she denies other allergic symptoms such as rash or pruritis
32 2021-03-22 mouth tingling tongue/lips tingling . Evaluated by EMS-Cleared
32 2021-03-22 tongue itchiness, tongue disorder pt reports thick feeling and tongue itching about 15 minutes after injections. Benadryl 50 mg given... Read more
pt reports thick feeling and tongue itching about 15 minutes after injections. Benadryl 50 mg given.
32 2021-03-23 mouth numbness Patient developed numbness of lips within 2 hours and left side of face. patient developed a burning... Read more
Patient developed numbness of lips within 2 hours and left side of face. patient developed a burning sensation on Left side of head later that day. Right foot started going numb 3 days later and then spread to shin after 3 days and by 1 week spread to waist and Left side of chest also. Patient then developed numbness in left leg and in perineal area. MRI lumbar spine was done to evaluate patient's history of herniated disc which had no significant change from previous MRI. So a brain MRI was ordered and patient was referred to a Neurologist
32 2021-03-23 swollen tongue, mouth tingling tingling lips, swollen tongue 8 minutes after vaccine given. Was given 25mg PO benadryl At 2:25pm t... Read more
tingling lips, swollen tongue 8 minutes after vaccine given. Was given 25mg PO benadryl At 2:25pm tingling stopped, tongue is better but wasn't back to baseline. 2:35 pm felt fine and husband took her home.
32 2021-03-24 ear discomfort, swelling of eyelid, eye pain, ringing in ears, visual impairment The day after the second dose I felt sweaty hot and nauseous. I was still really sleepy on the third... Read more
The day after the second dose I felt sweaty hot and nauseous. I was still really sleepy on the third day. My eye started hurting and I could hear a buzzing sound in both ears. It got worse and worse by day six and I was having trouble seeing out of my right eye. It was really painful underneath my eye on the inside corner with swelling on the top lid. The Steroids seemed to help the problem with my eye. The doctor suspected Bells Palsy. On week two I was prescribed steroids from Lymphadenopathy. I still have the ringing in my ears which is increasing after it had subsided for a little time. I also felt pressure in my ears which is very uncomfortable. Whenever I stop taking the Steroids the ringing in my ears returns like Tinnitus. I plan to reach out to a doctor again because the ringing in my ears has returned after it had improved but was still present after 10 weeks. I did not have any of the same symptoms after the same dose. I have seen a lot of professionals.
32 2021-03-24 mouth tingling Per patient, lips began tingling, progressed to tongue, then loss of sensation. Then felt throat cl... Read more
Per patient, lips began tingling, progressed to tongue, then loss of sensation. Then felt throat closing, and unable to get air. Pt went to the ER. Was given Benadryl, Prednisone, and Pepcid and sent home.
32 2021-03-25 mouth numbness 35 wks pregnant, noticed these symptoms the morning after having the vaccine: right side of the face... Read more
35 wks pregnant, noticed these symptoms the morning after having the vaccine: right side of the face is slightly paralyzed, when blinking only the left eyes blink and right eye does not fully close, right side of the tongue slightly numb but still able to taste, when smiling or manipulating mouth only the left side is fully engaged, right side if about 70% engaged, feel tightness on the back of right side of the head
32 2021-03-25 vision blurred Vasovagal within 2 minutes. Sweats blurred vision almost syncope. Numbness and tingling in arms last... Read more
Vasovagal within 2 minutes. Sweats blurred vision almost syncope. Numbness and tingling in arms lasting 10 minutes.
32 2021-03-28 eye pain Sinus headache/migraine started growing roughly 1hour after shot was administered, dull to sharp ach... Read more
Sinus headache/migraine started growing roughly 1hour after shot was administered, dull to sharp ache behind eyes and eyebrows, moderate to severe at moments until about 3pm on 3/27. Reappeared on 3/28 and was worst from 11am-1pm, 3-6pm, and 10pm-12am. Took 2 Tylenol every 6 hours, had no effect on diminishing symptoms. On 3/28 took 50mg of caffeine at 5:30pm in addition and that did reduce the pain for roughly 4hours. When headache was worst felt faintly nauseous. On 3/29 mild headache, took 2 Advil but the headache was still there. 3/27 at 6pm started noticing arm soreness, moderate soreness that evening, no treatment taken other than moving/massaging arm. 3/28 soreness was mild, 3/29 soreness was barely noticeable.
32 2021-03-28 gaze palsy Patient was wheeled in on a rolling chair(no wheelchair available at time) from nurse that administe... Read more
Patient was wheeled in on a rolling chair(no wheelchair available at time) from nurse that administered vaccine because of anxiety and a needle phobia that put the patient into a kind of shocked state. Patient was sweating profusely, white to the face, and not speaking very much but would answer questions correctly. EMT was speaking with the PT before walking away to continue other monitor duties when he turned back to see patient limp in chair, head back, eyes rolled back, and some twitching movements of the body. EMT called for rapid response because first thought of seizure and seizure like activity with the twitching movements. EMT got to patient, supported head up straight, and opened jaw to ensure airway was clear. Patient had no response to EMT trying to communicate. Sternum rub was performed where patient came back conscious nearly instantly. PT was unresponsive for roughly 10-15 seconds. Patient was told of what happened and vitals were taken on her, response team was cancelled with most them already on scene. PT was feeling better, sweating stopped, color to the face returned, and PT was speaking and understanding more clearly than before. PT was given a snack and water and was monitored by EMT for an additional 15mins before patient and staff were confident with her leaving.
32 2021-03-28 painful gums High fever 105, chills, shaking, pain through body, pain when moving, migraine, fatigue, gums were h... Read more
High fever 105, chills, shaking, pain through body, pain when moving, migraine, fatigue, gums were hurting. Took a moltrin.
32 2021-03-28 mouth tingling, mouth numbness Tingling/numbness in my mouth and ears started today 3/29/21 around 4pm
32 2021-03-29 eye swelling, eye pain Facial dermal fillers (Allergan Voluma and Volbella) in cheeks and under eye area performed in Augu... Read more
Facial dermal fillers (Allergan Voluma and Volbella) in cheeks and under eye area performed in August 2020 (Voluma in cheeks) and December 2018 (Volbella in under eyes) became swollen and tender to touch the morning of 3/27/21 36-48 hours after receiving 2nd Pfizer Covid vaccine. I took Prednisone 20 mg, one dose of Xyzal, and Benadryl 50 mg and swelling stayed stable (did not worsen but did not improve much) and tenderness persistent over the day. There was no redness or sign of infection to the area and no other symptoms associated. The next morning, 3/28/21, tenderness resolved completely and very minimal swelling was present which resolved over the day. By 3/29/21 there was no sign of any swelling.
32 2021-03-30 taste impairment, mouth numbness metallic taste in my mouth; numbness in certain areas of my face, particularly around my lips/facial... Read more
metallic taste in my mouth; numbness in certain areas of my face, particularly around my lips/facial numbness; numbness in certain areas of my face, particularly around my lips; local anesthetic; noticed some sporadic tingling in my legs on the day of the vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare profes-sional. A 32-years-old female patient received first dose of BNT162B2 (solution for injec-tion) via an unspecified route of administration on 01Feb2021 13:00 at single dose for for COVID-19 immunization. The patient medical history was not reported. Concomitant medica-tion included minerals nos, vitamins nos (PRENATAL VITAMINS), docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3), probiotics (PROBIOTICS), colecalciferol (VITAMIN D). The patient previously took erythromycin and experienced hypersensitivity. The patient experienced immediately after receiving the vaccine metallic taste in my mouth and numbness in certain areas of my face, particularly around my lips. The numbness isn't complete (I can still feel when I touch my face), but it feels like being partially recovered from a local anes-thetic. I also noticed some sporadic tingling in my legs on the day of the vaccine. The facial numbness issue persists on 01Feb2021 13:00. The event considered non serious. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
32 2021-03-30 eye pain, pupils dilated Disorientation, lightheadedness, dilated pupils, slurred speech starting around 3 hours after vaccin... Read more
Disorientation, lightheadedness, dilated pupils, slurred speech starting around 3 hours after vaccine dose. Felt like I had been heavily drinking, but I had no alcohol or drugs in my system and hadn't for several days. Lasted through when I went to bed around 10:30 p.m. (about 7 hours after vaccine dose). Felt mostly normal when I woke up the following morning (around 6 a.m.) except for eyes ached. Felt completely normal by noon the next day.
32 2021-03-30 feeling of choking PATIENT WITH HISTORY OF THROAT TIGHTENING WITH DOSE 1 OF COVID-19 PFIZER VACCINE 3 WEEKS AGO. VACCIN... Read more
PATIENT WITH HISTORY OF THROAT TIGHTENING WITH DOSE 1 OF COVID-19 PFIZER VACCINE 3 WEEKS AGO. VACCINE # 2 GIVEN TODAY IN TRIAGE 2 AS PRECAUTION. VS: 133/93 HEART RATE 71, PULSE OX 99% ROOM AIR DR. AT BEDSIDE. PATIENT REPORTED THROAT TICKLE AND TIGHTENING AT 10:23 AM. ZYRTEC 10 MG ORAL CHEWABEL TAB GIVEN TIMES 1 DOSE WITH BOTTLE OF WATER. DISCHARGED AT 10:35 WITH SYMPTOM RESOLUTION.
32 2021-03-30 ringing in ears, visual impairment I didn?t have many side effects in my arm right after the shot other than it being really sore for a... Read more
I didn?t have many side effects in my arm right after the shot other than it being really sore for about 20 min after leaving while I was on the way home. Other than that, it just felt like I had a bruise at the injection sight. I ran a slight fever of 99.4 on and off for the first few days but felt okay. No longer have a fever (but hard to tell because I?m taking Tylenol around the clock) but symptoms have progressed since the first few days and not getting better. Now for the bad... I?ve experienced tightness in the middle of my chest randomly, extreme fatigue, feet turning more blue/purple than the usual, sleeplessness, and headaches that are in the middle front part of my head (don?t experience these types of headaches. Usually I get more of a pressure headache to the left side of my head). I?m having random shooting pain under my eyes where the eye socket/cheekbones are (not usually correlating with my headaches). Started with the left side and now both get random shooting pains. I?ve never felt the pain under my eyes before until I got the vaccine. Random falling/rising stars (usually falling stars indicates a migraine) just happening more often than normal. My lymph nodes in my neck where my throat is, have been swollen on both sides worse on my left side (similar to how they react with strep). My joints and muscles have been worse than ever and swollen all over. Already had issues with my knees but now can hardly walk up and down stairs. I?ve also had ringing in my ears that can sometimes be intense. Vertigo and randomly feel like falling over. Collapsed on stairs a week after vaccine.
32 2021-03-30 ringing in ears Pulsating sounds in the ear, ringing, swooshing, discomfort, dizziness
32 2021-03-30 vision blurred Blurry vision almost black out when walking.; Blurry vision almost black out when walking.; Muscle a... Read more
Blurry vision almost black out when walking.; Blurry vision almost black out when walking.; Muscle ache; fever; Fatigue; This 32- year-old female patient contactable healthcare professional received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6203), via an unspecified route of administration, on 09Mar2021 at 09:00am (at the age of 32-years-old) as a single dose for COVID-19 immunization, in left arm. Patient is not pregnant. She has had no other vaccines on the same day or in the past 4 weeks. The patient did not have COVID-19 prior to the vaccine. Historical vaccine included first dose of BNT162B2 for COVID-19 immunization, on 16Feb2021, (Lot EN6200), in left arm. Relevant medical history included birth control use. Concomitant medications included: Junel birth control. On 09Mar2021 at 10:00 pm, the patient experienced Muscle ache, fever, fatigue, blurry vision - almost black out when walking. The patient received treatment of ibuprofen for the events. The clinical outcome of the events Muscle ache, fever, fatigue, blurry vision - almost black out when walking was recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19. Information about lot/ batch number has been requested.
32 2021-03-31 taste impairment, eye swelling lightheadedness immediately after vaccine administration for Pfizer today Has hx allergies includi... Read more
lightheadedness immediately after vaccine administration for Pfizer today Has hx allergies including tylenol Followed by allergist; prior testing w/ tylenol with delayed reaction about 60 minutes later involving eyelid swelling Pt also noted flushing, feeling of anxiousness, intermittent nausea, metallic taste in mouth, throat itching Had episode of diarrhea (once, small volume) ~ 20 minutes after vaccine Has warmth sensation mostly in toes Panic attacks in past responsive to meditation and deep breathing Vitals notable HR 100-109, BP > 150/90, o2 sat ~ 98% No visible hives No angioedema notable Cn 2-12 grossly intact Distressed non toxic appearance No flushing Lungs ctab no wheeze evident Bowel sounds present A/p Given hx severe allergies and clinical presentation, discussed w/ patient safest to monitor for anaphlyactic reaction in ER in context of prior delayed reaction - 25mg PO benadryl x 1 - monitor vitals - EMS notified
32 2021-03-31 mouth tingling tingling lips, lightheaded dizzy
32 2021-03-31 sensitivity to light Day of Vaccine, 03/27/21; felt fine after injection. After arriving home stiffness in left arm, felt... Read more
Day of Vaccine, 03/27/21; felt fine after injection. After arriving home stiffness in left arm, felt weak, and lethargic. Day after vaccine, 03/28/21; woke up feeling weak and lethargic 03/29/21; woke up with headache. Drove to work and became dizzy. Got into office and had light sensitivity. Headache continued room spinning and felt very nauseous. Finally threw up 4 times. Spend rest of day in bed. Hot and cold body temps. Low grade Fever 03/30/21; recovering slowly. Headache and weak but improvement after Advil and NyQuil.
32 2021-04-01 ear pain left eye and left side of mouth was not working/Bell's palsy.; left ear was hurting all day; drainag... Read more
left eye and left side of mouth was not working/Bell's palsy.; left ear was hurting all day; drainage in patient left ear; neck down to elbow was sore; neck down to elbow was sore/soreness on arm; neck down to elbow was sore; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (non-pregnant) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 13Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation. Medical history was none. Concomitant medications included metformin and prenatal vitamin. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. About 30 mins after the shot patient neck down to elbow was sore. On 14Mar2021 the soreness on arm went away but patient neck was still sore. 14Mar2021 night there was drainage in patient left ear. On 15Mar2021 patient left ear was hurting all day. 16Mar2021 morning (07: 45 am) patient woke up with no more pain in left ear, but left eye and left side of mouth was not working. Patient went to ER and they said patient have Bell's palsy. Patient had no control of the left side of face by 18Mar2021. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Event Bell's palsy resulted in emergency room/department or urgent care, disability or permanent damage, and patient received unspecified medications as treatment for the event. Outcome of events pain in arm/elbow was recovered on 14Mar2021, outcome of event left ear was hurting was recovered on 16Mar2021, outcome of events Bell's palsy and neck pain was not recovered, and outcome of event drainage in patient left ear was unknown.
32 2021-04-01 swollen tongue Vaccinated at 8:20AM started to feel dizzy and swelling in the throat 5 minutes later. Escorted via ... Read more
Vaccinated at 8:20AM started to feel dizzy and swelling in the throat 5 minutes later. Escorted via ambulation to bed, Benadryl 50mg po given. BP 120/78 HR 90. Color pink no swelling of the face tongue or throat noted. NP responded and transferred patient to Primary Care office. After observation, provided prescriptions for Prednisone, Atarax, Pepcid, already had Epi Pen at home. Able to go home and reported still feeling dizzy the next day via telephone.
32 2021-04-01 swollen tongue Patient complained of local tongue swelling. No hives or wheezing. Initially RMA'd but then reques... Read more
Patient complained of local tongue swelling. No hives or wheezing. Initially RMA'd but then requested a transport due to feeling weak & tired. Transported to Medical Center by EMS.
32 2021-04-02 pain in jaw Day of vaccination: fine until approx 11:30 pm. I developed a hot/itchy rash on legs followed by a f... Read more
Day of vaccination: fine until approx 11:30 pm. I developed a hot/itchy rash on legs followed by a fever of 103, checked with a digital thermometer, and an intense headache. The headache was the worst I?ve ever had and both the headache and fever lasted until the next day. The next day I slept on and off with a 103 fever until 1pm when I finally took Tylenol. The fever and headache slightly receded to about 100 for about 3 hours and then came back and rose to 104. I took more Tylenol and it receded again and came back again. I took two more Tylenol before bed. The next morning I woke up at 7 am and luckily my fever had dropped to 100 and below and I no longer felt the need to take my temp. However my entire upper body felt as though I was in a car accident and had severe whiplash. My neck and head were so painful I couldn?t move them and the arm that I had received the injection was hot and very painful. My other arm was also sore but not as bad and both my hands hurt. My left armpit and a spot under my jaw on the left were also very swollen and painful. I spent the day either unable to move or in tears pacing because the pain was so bad. I periodically took 600 ml of ibuprofen to help alleviate the pain which I think helped a little. I applied an ice pack to my neck and heat pad to the top of my head and rotated a third ice pack between my hands, under my jaw and in my armpit. It was the most severe body pain I?ve ever felt. This lasted until I went to bed. The third day most of the intense pain from the day before was gone but I still had a pretty intense headache and serious stiffness in my neck and head. Which progressively became more intense throughout the day. I continued to use ice and heat and take Tylenol. This pain lasted and increased until going to bed.
32 2021-04-02 ringing in ears I got the shot and started experiencing ringing in my ears 3 days later.
32 2021-04-03 taste impairment The patient expressed a metalic taste in her mouth in observation. Vitals were taken, an created by ... Read more
The patient expressed a metalic taste in her mouth in observation. Vitals were taken, an created by agency. A form was signed, the patient refused transport or treatment. Her husband was with her and said he would take her to the ED if anything changed.
32 2021-04-04 conjunctivitis 2 weeks after second COVID vaccine, immediately after taking polyethylene glycol (Miralax) had seve... Read more
2 weeks after second COVID vaccine, immediately after taking polyethylene glycol (Miralax) had severe pruritis of bilateral hands and feet with redness of the skin. Followed shortly by nausea and 1 episode of vomiting, hypotension (70s/50s), and chills. This passed over the subsequent couple hours then about 6 hours later developed sudden onset severe bilateral conjunctivitis which was so painful I couldn't open my eyes or see very well and ended up going to the ED. Seen by ophthalmology there and told it was likely viral conjunctivitis. Over the next couple hours this passed but then started to develop severe diffuse arthralgias which lasted about 1 day. This then passed and I felt completely fine. About 2 weeks later I tried taking Miralax again and about 6 hours after taking the Miralax developed the same severe diffuse arthralgias as the prior episode, which again passed in about 1 day. I had taken Miralax several times before getting vaccinated without any issue.
32 2021-04-04 oropharyngeal discomfort I had multiple treatments - about 15 office visits or more. Right after the vaccine, my throat was f... Read more
I had multiple treatments - about 15 office visits or more. Right after the vaccine, my throat was feeling super tight; I was very fatigued and very dizzy. I went home and I wasn't feeling well. They told me to monitor my symptoms. I went to Hospital- where I had the vaccine - ER around 2:00 pm. They provided me with an IV - Benadryl; prednisone; Pepcid. And provided me with an epi-pen - as swelling in my throat was not going down. I was released. After that, I took Tylenol and the other prescriptions. 25th - pretty bad headache; head fog - very tired; couldn't really articulate myself well. I slept all day. My throat was still feeling very tight and swollen. That went on for about 4-5 days after the vaccine. I had a phone appt with a dry (not my primary - but with a dr) on 25th - they told me to continue with Tylenol and the prescriptions - Benadryl; prednisone; Pepcid. January 26 - I had vertigo symptoms, joint pain; muscle pain; very brain fog with not being able to think - couldn't focus on my work. On January 27th, I went back to the ER - throat discomfort and chest tightness. They told me to continue to take what I was taking to give it more time. I had chest burning and discomfort in my chest area. It felt like gas bubbles almost. It felt uncomfortable. I followed up on January 27 with a doctor on the phone and she told me the same thing: stay hydrated; keep taking the meds and if I had shortness of breath to go back to ER. I had about 9 Doctor appts after that within January. I have seen my primary doctor and a physical therapist - I had lots of head fog and I couldn't think clearly. I had to take a leave of absence from work. I have fogginess and imbalance. I have an extreme balance and dizziness issue. I feel like I am on a ship trying to walk. I have never had these issues before the vaccine. I have been off work for 2 months. I cannot drive.
32 2021-04-05 thirst Patient had received vaccine 5 minutes prior and gone to the bathroom. She came back to sit in the w... Read more
Patient had received vaccine 5 minutes prior and gone to the bathroom. She came back to sit in the waiting room and then passed out in the chair. She reported that she had been nauseous prior to sitting down. She came back too quickly and stated that she was just thirsty and her chest was tight. 911 was called and they asked us to give her 4 chewable baby aspirin as a precaution. Before EMS arrived she was sitting up and talking with her husband.
32 2021-04-05 ringing in ears ears ringing
32 2021-04-06 lip swelling 5 days going to 6 of on and off fever, throat swelling, lip swelling, body aches, nausea.
32 2021-04-07 dry mouth, dry throat Pfizer-BioNTech COVID-19 Vaccine EUA Facial numbness and tingling. Excessive dry mouth and throat. F... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Facial numbness and tingling. Excessive dry mouth and throat. Felt constriction of throat at one point. Heightened anxiety. Mild sweating. Milding tingling sensation throughout parts of the body
32 2021-04-07 taste impairment Immediately following the injection, felt immediate metallic taste in mouth, warm sensation from hea... Read more
Immediately following the injection, felt immediate metallic taste in mouth, warm sensation from head to toe, lightheaded that almost lead to fainting (did not ever actually pass out), tachycardia... this lasted for about 5 minutes. Later that day I continued to feel flushed and had localized hives that went away on their own.
32 2021-04-07 mouth swelling, swollen tongue, eye swelling Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Aller... Read more
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe
32 2021-04-07 oropharyngeal discomfort Within 5 minutes of vaccine, felt rush through my body, became flushed, dizzy, throat heavy and unco... Read more
Within 5 minutes of vaccine, felt rush through my body, became flushed, dizzy, throat heavy and uncomfortable, nausea to the point of almost puking, rigors, shaky, light headed,. Was given epi, zofran, Benadryl in IV and 911 was called to take me to emergency room
32 2021-04-07 mouth tingling I had tingling in the back of my mouth about 45 min after injection. It wasn't to bad. Woke up the n... Read more
I had tingling in the back of my mouth about 45 min after injection. It wasn't to bad. Woke up the next morning with itchy skin and a hive rash on my lower belly, my body was achy arm was really sore did tylenol and heat pack on my arm, moved it and massaged the area very gently. The next day arm pain was gone but skin was very uncomfortable. By the end of the day around 7:30 I started to feel difficulty swallowing and got raspy and my skin was breaking out in more tiny follicle irritation bumps. Took zyrtec but headed to the er. Was discharged around midnight. I was given predniSONE, and a prescription for more over the next 4 days. I still feel really tired and sore. My breathing is better though and I will keep taking zyrtec. Was also adviced not to get second dose. I will follow up with my regular doctor next Thursday.
32 2021-04-07 swollen tongue, lip swelling Shortness of breath, lightheadedness, itching and swelling of tongue and lips
32 2021-04-08 taste disorder, mouth tingling, mouth numbness At time of shot got a slight medical type taste in mouth - about 9 hours later my face (around mouth... Read more
At time of shot got a slight medical type taste in mouth - about 9 hours later my face (around mouth area and then expanding out) started going tingly and numb. After a little while (about 30 mins) that sensation spread into my tongue. I started to get quite worried at that time and took 2 benedryl. The benedryl did seem to kick in and work. Arm also started to get sore around that time in the evening and was very sore the next day and then less sore, but still sore for a few days.
32 2021-04-08 ringing in ears Approximately six hours after the injection, I experienced a loud and low buzzing/humming sound in m... Read more
Approximately six hours after the injection, I experienced a loud and low buzzing/humming sound in my right ear. It also made me slightly dizzy. It has occurred twice since.
32 2021-04-08 ringing in ears High pitch ringing 3 days after first pfizer vaccine. Ongoing. Also had pressure in lower jar but t... Read more
High pitch ringing 3 days after first pfizer vaccine. Ongoing. Also had pressure in lower jar but that has gone away.
32 2021-04-10 ringing in ears I began having noticeable moderate tinnitus mostly in my right ear with very little in the left and ... Read more
I began having noticeable moderate tinnitus mostly in my right ear with very little in the left and pressure at my jaw pint below the ear and deep in the inner ear. It has been continuous since the 4th day after my second Pfizer dose. I?ll be seeing an ENT as soon as possible. It?s been very anxiety inducing as I have never experienced tinnitus in my life before and never had in prior ear or allergy conditions in my life to have correlated with this.
32 2021-04-10 ringing in ears Tinnitus in both ears, worse in left. Started a day or two after first vaccination, hadn?t gotten wo... Read more
Tinnitus in both ears, worse in left. Started a day or two after first vaccination, hadn?t gotten worse or better over the 3 weeks. Just got my second shot 2 hours ago, tinnitus is worse but not severe.
32 2021-04-11 loss of taste, loss of smell Employee tested Covid Positive on 4/11/21 after receiving Covid Pfizer vaccine 1st dose 12/21/20, 2n... Read more
Employee tested Covid Positive on 4/11/21 after receiving Covid Pfizer vaccine 1st dose 12/21/20, 2nd dose 1/23/21 . Onset of symptoms of headache, loss smell and taste on 4/11/21. Employee symptomatic, denies any need for medical services. Headache treated with PRN Tylenol.
32 2021-04-11 loss of taste, loss of smell Employee received Covid vaccine ;1st dose 12/21/20, and 2nd dose 1/23/2021. Employee reports onset o... Read more
Employee received Covid vaccine ;1st dose 12/21/20, and 2nd dose 1/23/2021. Employee reports onset of symptoms of headache , loss smell, loss taste and congestion on 4/11/2021. No medical services needed. Employee taking Tylenol PRN.
32 2021-04-11 ear discomfort throat tightness and feels like fluid in left ear and headache
32 2021-04-11 eye itchiness Pt experienced "slight symptoms of allergic reaction, eye itching, dizziness,etc" after receiving he... Read more
Pt experienced "slight symptoms of allergic reaction, eye itching, dizziness,etc" after receiving her vaccination.
32 2021-04-12 loss of taste, loss of smell Patient received 2nd dose of COVID vaccine on 1/20/21. Patient became symptomatic on 4/5/21 with ru... Read more
Patient received 2nd dose of COVID vaccine on 1/20/21. Patient became symptomatic on 4/5/21 with runny nose and headache. Patient then reported loss of taste and smell on 4/9/21. Patient received a monthly scheduled PCR COVID test for work on 4/9/21 and received a COVID positive test result on 4/10/21
32 2021-04-12 ear discomfort, ringing in ears Tinnitus in both ears noticed on 2am of the night after the shot was administered. Never experienced... Read more
Tinnitus in both ears noticed on 2am of the night after the shot was administered. Never experienced tinnitus before. Consistent ringing in both ears that has not changed, on top of it more pitches that appear randomly and loudly. gets worse with stress. adds stress anxiety and interrupts sleep and work. Visit to ENT concluded no hearing loss and ears look normal. Acupuncture and jaw massages help calm and relieve symptoms but still persisting. Full journal: Scale (1 - non existent, 10 - very bad) 01/04/2021 02:00am - white noise and pressure in ears : 2 9:00am - headache: 3, ears: 2, intermittent ticking on right ear (heard once or twice in the morning) 10:00am - + nausea :2 2pm - ear pressure and ringing more noticeable with headphones: 3 02/04/2021 2am - ear pressure went down, ringing on right ear high B: 3 4pm - ringing on right ear not noticeable unless i focus hard on it. 03/04/2021 9pm - ringing on right ear high Cish - not noticeable unless it is quiet : 3, pressure in both ears - 3 04/04/2021 12pm - ringing on right ear \- 3 pressure in right ear - 3 trying to put focus away all day. tried 10min ear exercises 04/05/2021 9am - did 10 min ear exercises 10am - pressure plus ringing in both ears - 1.5-2 6pm- acupuncture 04/07/2021 5-6pm - walk in city, still more sensitive to traffic and street noise, need to cover my ear frequently, friend noticed. 11pm - stressful conversation with partner, resolved 12am - ringing in right ear phased in louder volume (5/10) for 2 seconds and stopped. 7am - ringing in left ear phased in louder volume (7/10) for a second and resumed to normal volume, new pitch - high A - left ear - 3 (intermittent), right ear - 2 04/08/2021 2am - left ear high A 5/10 goes up and down in volume mainly 4-5. took a long bike ride yesterday (90 mins), walked in the cold for 30 mins in the evening - was not dressed enough. EST visit - washed left ear to take out wax. no hearing loss - hearing looks high normal. no more info on 2nd shot. 6pm - acupuncture 04/09/2021 5am - no high A anymore. left ear- 1.5, notice only when block my ear, right ear 2-3.5 (phasing in and out) high F# and maybe C too 04/10/2021 8am - left ear - 2-3 only high Bb, right ear - 2-3 no high f#, only high C , white noise in both - 2 4pm - stressful conversation with partner, resolved 5/10 04/11/2021 morning - barely noticeable 7pm - after being out all day and a little cold - high F# appeared again 3/10. no pressure in ear anymore 04/12/2021 9am - high C added to both again 3/10 10am - work virtual meeting - high C goes 5/10 9pm - after acupuncture feeling better overall, high F# again 2-3/10, no high C 04/13/2021 2:56am, 3am, 7am - woke up from bad new pitch - G 7/10. massaging jaw at 7am helped relief.
32 2021-04-12 eye swelling, lip swelling 36 hours later swelling began under one eye. At 48 hours both eyes swollen almost shut and half of l... Read more
36 hours later swelling began under one eye. At 48 hours both eyes swollen almost shut and half of lip swollen. Symptoms have not resolved on 4th day. Given steroids by general doctor after seeing him during 3rd day after vaccine.
32 2021-04-12 mouth tingling about five minutes post shot, I began experiencing throat swelling and tongue tingling with a feelin... Read more
about five minutes post shot, I began experiencing throat swelling and tongue tingling with a feeling of faint. That along with headache and fatigue continued for a few days. About six days postshot, I experienced facial parasthesis for several days that warranted an ER trip.
32 2021-04-12 feeling of choking Pt. stated, "I felt tingling in my throat 14 minutes after getting vaccinated." "It felt like the t... Read more
Pt. stated, "I felt tingling in my throat 14 minutes after getting vaccinated." "It felt like the tingling I had when I got an allergic reaction to hydrocortisone." Vital signs taken: B/P 110/70, O2Sat 99%, HR 88, At 11:28am, pt. reported feeling better, tingling is going away. At 11:32am pt. went home with husband.
32 2021-04-12 taste disorder, smell distorsion Rash and itching developed within 10 minutes; administered oral Benadryl. Anaphylaxis at 45 minutes;... Read more
Rash and itching developed within 10 minutes; administered oral Benadryl. Anaphylaxis at 45 minutes; administered 1 EpiPen at 45 minutes, 1 EpiPen at 50 minutes. Anaphylaxis subsided until 2 hours post-vaccination; administered an additional 2 EpiPens and an additional dose of oral Benadryl. Anaphylaxis did not return. Rash and itching were gone by hour 6 post-vaccine. Fever, chills, sore throat, anorexia, and lethargy developed 12-16 hours post-vaccine. Changes in sense of taste and smell developed 36 hours post-vaccine (could be related to seasonal allergies).
32 2021-04-12 ringing in ears Tinnitus
32 2021-04-13 extreme sound sensitivity, sensitivity to light The day after the vaccine I ran errands, returned home and started to do chores. In the middle of cl... Read more
The day after the vaccine I ran errands, returned home and started to do chores. In the middle of cleaning, a wave of nausea and sickness fell over me. I had what I am assuming was a strong immune response of the vaccine working: chills, sweating, achey, nausea, no appetite. As the day went on I started to get neck pain, headache, sensitivity to sound and light, back and abdominal pain, and strong painful muscle contractions. The next day I felt better, mainly sore and achey. The day after my symptoms returned (Monday) and I had a very hard time moving or eating or drinking. Tuesday and Wednesday I felt a little better, but still not well. Telemedicine appointment with my doctor on Wednesday, and blood work was drawn which was unremarkable. Thursday was also difficult, and Friday I forced myself to push through to cover office duties at my job. Saturday I felt better and saw a couple of friends, and Sunday I felt better as well until the evening when I felt a lot of neck pain, acheyness and weakness, headache, nausea, tingling and tremors. Monday was a repeat of this, and found if I lay down and don?t move it isn?t as bad. Tuesday was also difficult, a visit to the chiropractor temporarily reduced symptoms for a couple of hours. I also had night sweats and sometimes if standing too long sweats and balance problems. Motrin and Tylenol did not bring much relief, zofran helped with nausea.
32 2021-04-13 swelling of eyelid, eye itchiness Pt reports having R upper eyelid swelling, itching, redness by that same eve after 2nd dose, and the... Read more
Pt reports having R upper eyelid swelling, itching, redness by that same eve after 2nd dose, and then had HA ride side from shoulder to around R ear, then nausea, felt clammy/hot, and by 4/13/21 dev'd R eyelid rash, drooping, and R upper lip drooping, worse as day progressed, cont'd HA pain and eye felt gritty. Pt reports previous shingles to R thorax and severe chicken pox illness as child.
32 2021-04-13 ringing in ears About 10 minutes after receiving the Prizer shot, I began to feel dizzy. Nurses took my vitals and t... Read more
About 10 minutes after receiving the Prizer shot, I began to feel dizzy. Nurses took my vitals and they came back normal. The dizziness gradually intensified within the next 45 minutes. I lost my balance and required assistance to get into my car. My husband drove me home. Two days after receiving the shot, I visited a Urgent Care because the dizziness turned into a headache and a dull ringing persisted in both ears. The dizziness lasted 3 weeks. Today is 04/14/2021. The dizziness is mild and only comes up when turning too quickly or do strenuous work around the house.
32 2021-04-14 lip swelling, eye itchiness, eye swelling Allergy reaction, difficulty breathing, throat swelling, eyes and lips swelling, itchy eyes, dizzine... Read more
Allergy reaction, difficulty breathing, throat swelling, eyes and lips swelling, itchy eyes, dizziness/weakness diphenydrAMINE 50 ml, administered twice predniSONE was given once Inhaler was used 8 times when symptoms begins to help with breathing issues Stayed at the hospital for 2 hours, see improvement and was released Continues to take allergy medications for 2 days Allergy on the next day
32 2021-04-16 eye swelling, swollen tongue, mouth swelling Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Diff... Read more
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: rash on extremities
32 2021-04-17 blindness in both eyes, mouth numbness On 4/5/21, 3 days after the vaccine, I developed a piercing headache behind my right eye. Shortly af... Read more
On 4/5/21, 3 days after the vaccine, I developed a piercing headache behind my right eye. Shortly after the vision in the left eye started going in and out for a brief time. About 30 minutes later my left arm went completely numb, including my hand. This resolved after about 10 minutes, but then was intermittent for the next 2 hours. During this time, I also started having some mild and intermittent lower lip numbness. Speech felt different but was overall normal. The neurological symptoms were resolved by 11/12 that afternoon but headache lasted 48 hours. At the time I was 17 weeks pregnant, due approx. September 11. 1 precious history without any complications.
32 2021-04-18 eye itchiness, eye swelling 24 hours after vaccine was administered, patient states she had an allergic rxn. swollen and itchy ... Read more
24 hours after vaccine was administered, patient states she had an allergic rxn. swollen and itchy eyes and hives on face and neck. Patient went to ER and was given Benadryl Injection and Benadryl capsules for home use. After a week symptoms still persisted and patient went back to the ER and was given a 3 day course of Prednisone. Patient called pharmacy after the course of the Prednisone was finished without a resolution to the symptoms. Patient called the pharmacy and we recommended patient to see PCP, or go to ER or clinic. Patient agreed and will go to ER or clinic.
32 2021-04-18 mouth discomfort dizziness, disoriented, swelling of throat, burning lips
32 2021-04-18 visual impairment dizzy, nausea, seeing black spots. Evaluated by EMS-Refusal to transport.
32 2021-04-19 eye pain, vision blurred I experienced eye pain, cold hands, blurred vision, headache, fatigue, pain at the injection site a... Read more
I experienced eye pain, cold hands, blurred vision, headache, fatigue, pain at the injection site after receiving the vaccine. I have recovered from all except intermittent cold hands and intermittent eye blurriness.
32 2021-04-19 eye pain Shortly after shot arm became hard to move. Next day, April 14th, arm was very sore and had issues r... Read more
Shortly after shot arm became hard to move. Next day, April 14th, arm was very sore and had issues raising it above collar bone without pain in arm or shoulder. Next day soreness went away and everything was fine until April 17th. I went to dinner with my family and started getting a headache on the way back. I laid down for an hour and a half, but the pain was just as bad. After getting up I took Tylenol and it seemed to make the pain go away. On Sunday, April 18th, I woke up with sever pain from my shoulder, neck, and head. I also had body aches and my eyes were really sore. Looking side to side was really painful. I was only awake from 1 to 5. I slept the rest of the day and didn?t have much of an appetite. I?m pretty sure I had a fever at one point because I got chills, but I didn?t take my temperature. The next day, April 19th, I called into work because I was still having the same shoulder, neck, and head pain along with the eye soreness. I took ibuprofen around 12pm, and started feeling a bit better. I still had no real appetite; I ate cause I knew I needed to and very little. That night I was running a 100.4 fever. Throughout the night I had chills and hot spells. I woke up in the middle of the night and my pants and shirt were drenched in sweat. I woke up this morning, April 20th, feeling much better. I only have slight discomfort with my eyes and my appetite is back. I am currently running a low grade fever of 99.2 which is causing me to sweat badly. Hopefully the worst is over.
32 2021-04-19 mouth numbness, taste impairment First few days just fatigue and wore off by day 3. It's day 5 and I still have a huge, and growing,... Read more
First few days just fatigue and wore off by day 3. It's day 5 and I still have a huge, and growing, red rash-like at injection site. This is warm to the touch, hurts, and inflamed. Itchy throat, numb tongue, and metallic taste (even when not eating).
32 2021-04-20 inability to speak One day after shot: body aches, pain In both legs. Three days after shot: pain in shoulder and upper... Read more
One day after shot: body aches, pain In both legs. Three days after shot: pain in shoulder and upper chest, particularly when inhaling Five days after shot: loss of voice, sharp shooting/crushing pain in left chest cavity, increased pain when breathing Six days after shot: diagnosed with Pulmonary embolisms in left lung, pleurisy, and inflamed lymph nodes near left lung.
32 2021-04-20 oropharyngeal discomfort Pt developed generalized pruritic, without hives, sensation of throat closing, swelling, chest pain,... Read more
Pt developed generalized pruritic, without hives, sensation of throat closing, swelling, chest pain, SOB or abdominal pain, pruritis intensity rated as 3-4/10. Heart + lungs, clear to auscultation, no facial/lip tongue/oropharyngeal swelling, no hives Pt was given benadryl 25 mg capsule Symptoms resolved within a few minutes of taking benadryl She was advised not to drive herself home
32 2021-04-20 swollen tongue On Sunday, 04/18, I went and received my second dose of the Pfizer vaccine at 12:30 pm on my left ar... Read more
On Sunday, 04/18, I went and received my second dose of the Pfizer vaccine at 12:30 pm on my left arm. It hurt much sooner than the first, within a couple hours. It hurt worse as well. The next morning was Monday. My arm was super sore. I work from home and went by my normal routine. Oatmeal with raspberries and blueberries. I eat this every day. I started work at 9 AM. Around 9:30 Am or so, I started having sneezing fits. Which I thought was annoying more than anything, but didn't think anything of it, until the fits developed into my hands itching, burning, turning red. I looked at my face and noticed it was red and swelling. I've had skin allergies before, but nothing outside of hives and maybe a little skin swelling. I have an allergy to bees. Worse that ever occurred was hives. This instance did not produce hives but a very beet red rash and swelling. Then very quickly after, my tongue started swelling and my throat started tightening. I called my mother as I noted this was life threatening and went to the ER. I was informed I had experienced anaphylaxis. My heart rate going in to the ER was 166. I have never experienced this in the 32 years I've lived before. I was administered an Epi and steroids. As soon as I realized what it was, even in my panic, I was lucky to make a judgment call to save my life. The doctor said to throw out the berries just in case. The odd thing is, I eat this every day...no issues. I realize it is rare for reactions to be delayed, but was made aware it is possible. I was not stung by anything to make this occur.
32 2021-04-20 taste disorder A half hour after receiving the shot I noticed a taste of iron in my mouth. The evening after my sec... Read more
A half hour after receiving the shot I noticed a taste of iron in my mouth. The evening after my second dose I got my period, I was not due to have my period for another two weeks. My period was very heavy flow, extremely painful cramps. Four days after my period started I experienced heavy and severe nose bleeds. The nose bleeds felt concerning - they would start randomly and flow heavy, taking 5min to stop. I felt very fatigued.
32 2021-04-20 vision blurred, double vision Extreme fatigue, vertigo, double vision, blurry vision, excessive sleeping, muscle weakness, muscle ... Read more
Extreme fatigue, vertigo, double vision, blurry vision, excessive sleeping, muscle weakness, muscle soreness, mild fever, no energy
32 2021-04-20 vision blurred Faint/dizzy, blurry vision, itchy throat. Ate crackers, and drank water felt better.
32 2021-04-20 eye floaters, light flashes or floaters in the eye Went to ER on 12/26/20 due to change in vision in left eye (flashes and floaters). Retinal specialis... Read more
Went to ER on 12/26/20 due to change in vision in left eye (flashes and floaters). Retinal specialist did dilated eye exam and found vitreous detachment occurring. Then, on 1/2/21, lost small part of vision and returned to retinal specialist with diagnosis of retinal detachment.
32 2021-04-21 loss of smell, loss of taste VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being ... Read more
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/13/21pfizer,Lot#EL3248 2nd dose: 02/03/21Pfizer,Lot# EL9264 Diagnosed covid positive:04/19/21 Exposure:Unknown Symptoms:loss of smell,taste,ABD pain,runnny nose,sneezing.
32 2021-04-21 mouth tingling Left hand and fingers started to get numb almost immediately. Then on the way home, 50 minutes after... Read more
Left hand and fingers started to get numb almost immediately. Then on the way home, 50 minutes after, half of the left face started to go numb. Had a tingle sensation mouth and tongue
32 2021-04-21 mouth tingling Tingling and hard to move left arm (same arm as vaccine), also tingling in lips about 20 mins after.... Read more
Tingling and hard to move left arm (same arm as vaccine), also tingling in lips about 20 mins after. A noticeable rash appeared approximately an hour after my appointment.
32 2021-04-21 ringing in ears felt flushed/hot, ears ringing, light headed
32 2021-04-23 eye discomfort, ear discomfort, eye pain, eye itchiness, swelling of eyelid On 4/12/21 I woke up with a painful bump and rash on my left eyebrow. On 4/13/21 I went to the docto... Read more
On 4/12/21 I woke up with a painful bump and rash on my left eyebrow. On 4/13/21 I went to the doctor and was misdiagnosed with cellulitis. I began treatment with antibiotics (clindamycin). The rash was unresponsive to the treatment and I started experiencing terrible pain in my face, eye and scalp. There was intense pressure in my eye and pain in my left ear. I started forming blisters on my eyebrow, side of my nose and temple. On 4/16 I woke up with my eye nearly swollen shut. I went to urgent care the same day and was diagnosed with shingles that was affecting my trigeminal nerve. I was prescribed Valtrex antiviral for 7 days, and remained on the antibiotics. I was also given pain medication (oxycodone). I was referred to Optometry to check to make sure the shingles was not affecting my eyeball and to ensure there was no indication of damage to my vision. As of today (4/24/21) my blisters have mostly scabbed over, the swelling has reduced substantially and the pain is far less intense. I still feel like a quarter of my face has a moderate sunburn, have an itchy eye and a bit of pressure in my eye still. My vision was not impacted and I may have some small scars from the blisters.
32 2021-04-23 mouth tingling, dry throat 5:34pm- Patent reports lips and tongue tingling. 5:41pm- Forehead tingling also. Patient denies any ... Read more
5:34pm- Patent reports lips and tongue tingling. 5:41pm- Forehead tingling also. Patient denies any shortness of breath, denies chest pain. 5:46pm-Patient reports left side of neck tingling. 5:49pm- Patient reports whole face tinging and headache. B/P 122/86, pulse ox 98% on room air, RR 22, HR 97. 5:51pm- patient reports tingling to left hand. 5:58- 50 mg of Benadryl (Dye-free) given orally. 6:02pm- Patient reports inside of nose tingling. NO wheezing noted to auscultation. 6:13pm- pulse ox 98% room air, HR 89, RR 18. 6:14pm- Patient states all tingling still present and more pronounced. 6:16pm- Patient reports back of throat dry and scratchy. 6:24pm- Patient continues to have tingling to lips, tongue, forehead, left side of neck, left hand, and nose. Patient reports tingling is ?not as pronounced?. NO respiratory symptoms. Patient states scratchy throat ?feels better? but symptoms of scratchy throat still present. Discussed need for further assessment and care at hospital or urgent care. Patient wants Mom to drive her to ER. Mom verbalizes understanding to call 911 en route to hospital if patient symptoms increase in any way. 6:42pm- Patient left for Hospital ER with Mom driving. Report called in to Hospital and given charge nurse in ER, by Emergency Nurse that cared for patient onsite. Benadryl was not given initially due to patient report of red dye allergy. Health Department nurse went to local drugstore and purchased dye- free Benadryl. Onsite Emergency Nurse present with patient throughout entire event.
32 2021-04-24 dry mouth Pt reported lightheadedness, dry mouth and anxiety at 1000. Pt vitals were BP 130/80 mmHg, HR 75 b... Read more
Pt reported lightheadedness, dry mouth and anxiety at 1000. Pt vitals were BP 130/80 mmHg, HR 75 bpm, and SpO2 99%. Pt given water and advised to wait for further observation. At 1034, pt reassessed. Vitals were BP 125/80 mmHg, HR 72 bpm, and SpO2 99%. At 1035, pt reported feeling okay. Pt left facility to self with steady gait and unlabored respirations.
32 2021-04-24 taste impairment strong metallic taste; flushing; a warm sensation from her head to her toes; lightheaded; fast heart... Read more
strong metallic taste; flushing; a warm sensation from her head to her toes; lightheaded; fast heartbeat; 2 hives appeared on her chest; This is a spontaneous report from a contactable consumer (patient). The 32-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced strong metallic taste, flushing, a warm sensation from her head to her toes, lightheaded, fast heartbeat, 2 hives appeared on her chest on 06Apr2021. Reported as: immediately after receiving the vaccine she experienced a strong metallic taste, flushing and a warm sensation from her head to her toes, she also felt lightheaded, and a fast heartbeat; after 5 minutes she felt better and these symptoms subsided. In the afternoon 2 hives appeared on her chest. She's not experiencing these symportoms currently. Patient states that she already talked to her HCP and she's most likely not gonna proceed with the second dose of the vaccine at this time, so she will not have increased immunity against Sars-CoV-2, she would like to know if this is true, and the efficacy after one dose of the vaccine. The outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
32 2021-04-24 sensitivity to light, ear pain, pain in jaw Sore Arm day after getting Vaccinated: Lasted a few days and faded away until there was no pain. Fel... Read more
Sore Arm day after getting Vaccinated: Lasted a few days and faded away until there was no pain. Felt very Fatigued the day after getting the Vaccination: Lasted several days. But, got better with time. Adverse event I wished to report: Seems this Vaccine might have, temporarily, hindered the effectiveness of a medication I take. I'm on Amytriptyline 25mg, 2 a day at one time, for Postherpetic neuralgia on the right side of my face & right ear. This Amytriptyline medication has helped to cease all pain, including migraines, that I get from the Postherpetic neuralgia, and has also helped with the pain of pinched nerves in my back. Due to that, this medication has really helped improve my quality of life. After getting the Vaccine, I went home and felt fine the first night. When waking up the next day, I found myself experiencing pain on the right side of my face and in my right ear. Thought this was odd as I took my medication the night before. But, as the day went on, it got a bit worse. That night i had trouble sleeping due to it. Then, the next day, I awoke with not only the pain at a level that it was before having treatment for it, but it also caused light sensitivity, migraines, and I could feel the right upper part of my jaw hurting as if teeth were aching that have been pulled years ago. I was also having vertigo when the ear pain got too bad. This went on for several days and then faded away around the 20th of April 2021. Although I was confused as to why the Amytriptyline didn't seem to work as well on those days, I figured that it must be something to do with the vaccine effecting my nerves, or interacting with this medication. I did not seek medical advice for this reaction, as it went away. But just wanted to report it using this form. Thankyou.
32 2021-04-24 sudden hearing loss Sudden hearing loss; This is a spontaneous report from a contactable consumer (patient). A non-pregn... Read more
Sudden hearing loss; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Apr2021 at 18:00 (6:00 PM) (at the age of 32 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included spironolactone and atomoxetine. The patient experienced sudden hearing loss on 06Apr2021. The patient did not receive treatment for the event. It was unknown if the patient has COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. Outcome of the event was unknown. Information on the lot/batch number has been requested.
32 2021-04-24 ringing in ears Bilateral tinnitus. I've had tinnitus since I was 10. I hardly noticed it previously. A couple days ... Read more
Bilateral tinnitus. I've had tinnitus since I was 10. I hardly noticed it previously. A couple days agter my second COVID 19 shot, I noticed large uptick to the point that it's now impacting my ability to sleep and function throughout the day.
32 2021-04-25 tongue itchiness developed itching on the tongue and skin post vaccine
32 2021-04-26 mouth numbness On day 5 the patient reported numbness in lips/mouth. Also noted face pain. Symptoms resolved by ... Read more
On day 5 the patient reported numbness in lips/mouth. Also noted face pain. Symptoms resolved by day 8
32 2021-04-26 mouth tingling, mouth numbness Within minutes, patient stated she was very light headed and felt like she was going to vomit. Patie... Read more
Within minutes, patient stated she was very light headed and felt like she was going to vomit. Patient then proceeded to pass out, but returned responsive within 30 seconds. Patient came to, but was unable to speak or respond immediately. She was able to nod her head and open and close her mouth. However, she was not speaking. When prompted with the question of whether she felt like her throat was closing, she nodded her head. However, patient continued to breath effectively and swallow. I asked if her lips were tingly and she responded yes. I asked if they felt numb and she responded yes. I proceeded to give her 25mg of oral diphenhydramine. Patient swallowed the liquid with no trouble. She was slowly opening and closing her eyes. Within minutes, patient started to speak again as well. I continued to ask her what her name, date of birth, day of the week and patient was able to correctly answer. She continued to take very deep breaths, and paused in between speech. I asked the patient to count backwards, which she successfully did. She was also able to squeeze my hands, and felt pressure on her arms and legs. She complained of her legs and arms "feeling numb and tingly". She was also able to provide us with her cell phone code and told us how to reach her husband. EMS arrived within 10 minutes of initial reaction. She left the pharmacy and was transported to local hospital.
32 2021-04-27 tongue itchiness 11 to 12 hours after the shot, I feel mild itching on both sides of the tongue.
32 2021-04-28 vision blurred sore arm for 36 hours, Persistent headache that started on the morning of 4/28. Nausea starting at 6... Read more
sore arm for 36 hours, Persistent headache that started on the morning of 4/28. Nausea starting at 6:30 pm. Violent vomiting starting at 10pm. Dizziness / spins and chills starting at 10:30pm. Headache, Nausea and inability to keep solids down continuing. Occasional dizzy spells/ brief blurred vision morning of 4/29. Unable to sleep.
32 2021-04-29 feeling of choking Caller states she just left the Hynes Center after her second dose of Pfizer and her arm feels heavy... Read more
Caller states she just left the Hynes Center after her second dose of Pfizer and her arm feels heavy and there is a bump by her elbow. Instructed caller to have her PCP or another healthcare provider assess her arm since I cannot see it. Caller states she is walking back to the Hynes center to have it assessed. Caller also states that she sat for 30 minutes and her throat felt tingly, but has subsided. She alerted a healthcare professional there who observed her and cleared her to leave.
32 2021-04-29 ringing in ears 72 Hours post-vaccine, I began to experience severe pulsatile tinnitus in the left ear, headaches, l... Read more
72 Hours post-vaccine, I began to experience severe pulsatile tinnitus in the left ear, headaches, lightheadedness, tingling/cold sensation in my left arm. Also can report an instance of "covid-toes" for a short period of time.
32 2021-05-01 inability to speak Full body rash, hives and blisters. Started out localized on back of head and neck. Now covers full... Read more
Full body rash, hives and blisters. Started out localized on back of head and neck. Now covers full body. Dizziness, chest pain, swollen throat and back of the base of my skull. Rapid heart rate and difficult my breathing. Loss of voice. Chills, body aches and pains. Stingy, burning and stabbing sensations all over. Transported by paramedic to ER. Given Epi shot, Benadryl and steroids.
32 2021-05-02 mouth numbness Patient received 2nd dose of Pfizer COVID vaccine; reported no issue with first dose other than loca... Read more
Patient received 2nd dose of Pfizer COVID vaccine; reported no issue with first dose other than local irritation. Patient waited 15 minutes at the pharmacy, and then left the store. She started driving away and then started to feel unusual. She turned around and came back to the pharmacy for observation, where she reported her face and especially ear were very hot and felt like they "were on fire." Pharmacist administered 10cc (25mg) of Benadryl and gave patient an ice pack and proceeded to sit with her to make sure she was okay. Patient then reported that her face and lips were starting to feel numb, so we called 911. We continued to watch her until the paramedics arrived to take her to the hospital.
32 2021-05-02 ringing in ears Headache across forehead(6 hours), ear ringing/sensitivity, joint pain (especially knees-2 days), fa... Read more
Headache across forehead(6 hours), ear ringing/sensitivity, joint pain (especially knees-2 days), fatigue(3 days), muscle soreness(1 day), constipation (2 days)
32 2021-05-03 ear pain, ear discomfort, ringing in ears Developed pain, ringing, and popping in left ear about 5 days after first dose. Symptoms have remain... Read more
Developed pain, ringing, and popping in left ear about 5 days after first dose. Symptoms have remained the same since.
32 2021-05-03 mouth tingling, lip swelling, swollen tongue Patient complained of lips swelling and tongue tingling/swelling. BP 162/109, HR 123, RR 24, O2 sat ... Read more
Patient complained of lips swelling and tongue tingling/swelling. BP 162/109, HR 123, RR 24, O2 sat 100%, temp 97.4. Patient taken to ER. Pt reported history of anaphylaxis to polio vaccine and TB as child. In ER, stated she was feeling anxious and hyperventilating during that time. Symptoms are improved.
32 2021-05-05 ear pain, eye movement disorder Patient began having a Twitching to her Left eye within 24 hours after vaccination. Patient then beg... Read more
Patient began having a Twitching to her Left eye within 24 hours after vaccination. Patient then began having a severe headache and pain that comes and goes in the back of her Left ear approximately 72 hours after injection. On 05/01/2021 Patient had numbness and paralysis on her left side of her face and assymetrical smile. Patient went to the Emergency Department and was diagnosed with Bells Palsy
32 2021-05-05 eye itchiness, eye discharge, dry throat, bloodshot eyes Initial, I had 3 days of left arm soreness. About 1 week later, I noticed moderately severe neck pai... Read more
Initial, I had 3 days of left arm soreness. About 1 week later, I noticed moderately severe neck pain. I was not able to sleep on my pillow and thought it was a muscle strain. Took Ibuprofen sparingly with good relief. One week later, I noticed tender right armpit (at the region of lymph node). The following week, I noticed right occipital lymph node enlargement, right supraclavicular lymph node tenderness, and moderately severe left occipital headache. I took Ibuprofen with good relief of left occipital headache. Seasonal allergies symptoms including runny nose, sneezing, itchy red eyes, eye discharge, tearing, nasal congestion, and dry throat coincided with these symptoms for 2 weeks. I took loratadine 10 mg and applied Alaway eye drops on several occasions. I began applying ofloxacin eye drops with resolution of eye discharge and treatment coincided with second Covid 19 vaccine on 5/1/2021. I also began taking MitoQ supplement. I had discontinued loratadine 10 mg and Alaway eye drops one day prior to second dose. Lymphadenopathy also resolved except right occipital lymph node is still enlarged. A mild headache, chills, and bodyaches began on 5/1. It worsened the following day. It was on the left frontal and maxillary sinus regions and left occipital region. Mild left knee itching, redness, and warmth began. On the following day, left knee itching, redness, and warmth slightly worsened and right and left sides of right and left hind feet began itching and maculopapular rash began. On 5/5, skin is hypersensitive. Maculopapular rash began on left ventral aspect of hand and resolved with application of hydrocortisone 1% cream. Bilateral arms also began itching and resolved on its own. Bilateral knee itching, redness, and warmth and hindfoot itching comes and goes. I began noticing bilateral cheek redness and warmth (flushed) that continues today on 5/6.
32 2021-05-05 bloodshot eyes Red eye, head ache, fatigue
32 2021-05-05 oropharyngeal discomfort Patient had hypersens reaction to first dose of COVID-19 Pfizer vaccine. Patient became nauseous, ri... Read more
Patient had hypersens reaction to first dose of COVID-19 Pfizer vaccine. Patient became nauseous, rigors, dizzy, flushed, throat discomfort. Epi pen given x1, Zofran ODT given. IV placed. Patients symptoms persisted. Patient transferred to ED.
32 2021-05-05 ringing in ears, deafness 4/20/21 hearing loss R ear, ringing in R ear, dizziness, headaches went to ER, then was referred to ... Read more
4/20/21 hearing loss R ear, ringing in R ear, dizziness, headaches went to ER, then was referred to ENT- Dr. diagnosed with sudden hearing loss. Recommend steroids (oral or injectable) which she has not yet started Caller reports she will not be getting 2nd vaccine
32 2021-05-05 ringing in ears Prolonged tinnitus in right ear about 6-12 hrs after vax. Hearing first got weird in the right ear ... Read more
Prolonged tinnitus in right ear about 6-12 hrs after vax. Hearing first got weird in the right ear - sounded muted, and could hear a lot better in the left ear. Then, tinnitus started continuously for about 2 hours. After that, it was on and off periodically until bedtime. The tinnitus was gone by the next morning. I normally very very rarely get tinnitus, and usually for no more than ~2-10 minutes.
32 2021-05-06 dry throat 1541-patient developed itchy/dry throat, flushed face and upper chest noted Vital signs taken BP-151... Read more
1541-patient developed itchy/dry throat, flushed face and upper chest noted Vital signs taken BP-151/104, HR 102, 100 % on RA symptoms persisted-benadry; 50 mg po given as advised MD 1600-patient symptoms improved ,D/C home
32 2021-05-06 visual impairment 48 hours after the injection (3/17/21) I experienced dizziness, vertigo, and nausea that was accompa... Read more
48 hours after the injection (3/17/21) I experienced dizziness, vertigo, and nausea that was accompanied by tingling and numbness on my left side and changes to my vision on the left side. The symptoms exacerbated to a severe level one week later, which led me to visit urgent care (3/24/21). They performed a physical evaluation and told me to follow with my primary care provider for further testing if it did not resolve. It did not resolve so I saw my PCP on 3/30/21 and she ran routine lab work, which mostly came back normal. She instructed me to see my rheumatologist to get more testing. I saw my rheumatologist on 4/6/21 and he performed lab work which revealed some abnormality (see below), and ordered 3 MRIs for 5/3/21. He also suggested I see a neurologist. The MRIs revealed a single brain lesion, and I am scheduled to see the neurologist on 8/5/21. While my symptoms have improved they have been debilitating. I have not been able to work at my restaurant job, I have been unable to drive, and I briefly moved in with my parents for more support.
32 2021-05-08 lacrimation increased Headache Fever Chills Body Ache Watery Eyes Join Pain
32 2021-05-08 smell distorsion, taste impairment Chills, whole body pains, nausea, headache, chemical aftertaste after ingesting food (only ate soup)... Read more
Chills, whole body pains, nausea, headache, chemical aftertaste after ingesting food (only ate soup), chemical smells toward food and other things that contain odor.
32 2021-05-08 ringing in ears Immediately felt cramping in my abdominal. Minutes later my feet and legs went numb, following ring... Read more
Immediately felt cramping in my abdominal. Minutes later my feet and legs went numb, following ringing in my ears. I began to sweat and needed to lay down. My throat began to tighten and swallowing became difficult. I was closely monitored for about 30 minutes, as my symptoms started to lessen. It?s two days later and the cramps and weakness/ numbness are still there.
32 2021-05-10 mouth tingling About 5-10 minutes following first vaccine I started to feel ?funny? my throat felt a little swollen... Read more
About 5-10 minutes following first vaccine I started to feel ?funny? my throat felt a little swollen and lips started tingling. I then started to feel hot and sweaty. This lasted about 20-30 minutes then I felt ok to leave. I did get sharp pains in my muscle from shoulder to neck on and off the rest of the day along with waves of nausea and being very tired. No medications were given.
32 2021-05-10 feeling of choking Burning in throat feels similar to acid reflux but with tingling also present in throat. Started ab... Read more
Burning in throat feels similar to acid reflux but with tingling also present in throat. Started about 36 hours post shot still continuing. Diarrhea started 36 hours post shot still continuing.
32 2021-05-10 swelling of eyelid Swollen eyelids, have not been treated, condition persists
32 2021-05-10 ringing in ears My ears started ringing about a week after the first dose. They have not stopped. First dose was 3/9... Read more
My ears started ringing about a week after the first dose. They have not stopped. First dose was 3/9/21, second dose was 3/30/2021 Lot #EP6955.
32 2021-05-10 ringing in ears Constant ringing in both ears; perceived to be ringing inside head. Extremely bothersome, to the poi... Read more
Constant ringing in both ears; perceived to be ringing inside head. Extremely bothersome, to the point of headache-inducing
32 2021-05-10 vision blurred I woke up the next morning around 9 am feeling very dizzy. Upon trying to get out of bed I fell over... Read more
I woke up the next morning around 9 am feeling very dizzy. Upon trying to get out of bed I fell over because my vision was sideways. I layed back down for a few hours. Upon rising again, my vision was again sideways and the dizzying effects lasted intensely for the remainder of that day. The following day I was able to go to work but by mid-afternoon had to lay down again and was unable to do yoga for the following 5 days. For a total of 2 weeks, I felt nauseous and dizzy. Now, once a week I feel dizzy still but positional therapy has helped me get back to my work and exercise lifestyle.
32 2021-05-11 painful gums, pain in jaw A fee hours after my second dose my right side of my face started to hurt, it started in my gum but ... Read more
A fee hours after my second dose my right side of my face started to hurt, it started in my gum but then 15 min after my upper and lower jaw on my left side was in excruciating pain, I am unable to open my mouth all the way and the pain goes up into the left side of my head. It felt as though my face was being beat in. This all started at the same time that my injection site got extremely sore. The site was sore after the shot but just got progressivly worse, but no redness, site felt warm to touch but other than that it seemed okay. My face and jaw still are in pain and the use of over the counter pain medication is doing nothing.
32 2021-05-11 mouth tingling Pt. reported tingling in arms, fingertips and tongue. Pt. was seen by Fire Rescue. Vitals were wit... Read more
Pt. reported tingling in arms, fingertips and tongue. Pt. was seen by Fire Rescue. Vitals were within range. No further treatment was given. Transport to ER was declined. Symptoms resolved and patient left the park at 1:10pm.
32 2021-05-11 swollen tongue Bell's Palsy; swollen tongue; itchiness; This is a spontaneous report from a contactable consumer (p... Read more
Bell's Palsy; swollen tongue; itchiness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 28Jan2021 14:30 (Batch/Lot Number: EL9262) (at the age of 32 years) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included immunoglobulin g4 related disease (IGG4-RD) and rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took rituximab (RITUXAN) and experienced drug allergy and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1686) in the left arm on 07Jan2021 at 02:30 pm for COVID-19 immunization and experienced rash in face and back. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 01Apr2021, the patient experienced Bell's Palsy, swollen tongue and itchiness. The events resulted in emergency room/department or urgent care. The patient was hospitalized for the events for 3 days. The patient received treatment for the reported events. Since the vaccination, it was unknown if patient has been tested for COVID-19. The outcome of the events was recovering.
32 2021-05-11 ringing in ears, deafness Temporary but loud tinnitus and hearing loss. Comes and goes every few days
32 2021-05-12 eye swelling I woke up the next morning with swelling under my eye. Within about an hour of noticing, the swolle... Read more
I woke up the next morning with swelling under my eye. Within about an hour of noticing, the swollen area increased in size and spread to the area between the bridge of my nose and eye, and above my eye up to my eyebrow. This was all on my right eye.
32 2021-05-12 mouth numbness, mouth tingling very tired; tingling and numbness on her face around her mouth that spread out to the tip of her nos... Read more
very tired; tingling and numbness on her face around her mouth that spread out to the tip of her nose; tingling and numbness on her face around her mouth that spread out to the tip of her nose; numbness and tingling spread into her tongue and eventually to the back of her tongue; numbness and tingling spread into her tongue and eventually to the back of her tongue; sore arm; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date at 10:30 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On the day of vaccination at 19:30-20:00 the patient experienced a reaction. The patient had tingling and numbness on her face around her mouth that spread out to the tip of her nose. After 45 minutes the numbness and tingling spread into her tongue and eventually to the back of her tongue. The patient also experienced a really sore arm that last for 3 weeks. She could feel the injection site for almost a week. The patient was very tired the next day but was not sure if that was due to the vaccine or taking diphenhydramine. The patient was nervous about getting the second dose of BNT162B2. The patient was treated with diphenhydramine (BENADRYL) and the numbness and tingling stopped after the medication started working. The outcomes of very tired, sore arm, tingling and numbness on her face and nose, and numbness and tingling on her tongue were unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
32 2021-05-13 ringing in ears Tinnitus
32 2021-05-14 ringing in ears This is a spontaneous report from contactable healthcare professional (patient). A 32-year-old non-p... Read more
This is a spontaneous report from contactable healthcare professional (patient). A 32-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3246) intramuscularly in left arm on 27Jan2021 at 11:00 (at the age of 32 years) as 2nd dose single for COVID-19 immunization. The patient medical history included asthma. The patient previously took codeine and experienced allergy. Concomitant medication of the patient included amphetamine aspartate, amphetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 30 mg received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number:Unknown) intramuscularly in left arm on 04Jan2021 at 13:00 as 1st dose single for COVID-19 immunization. Patient did not receive any vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 27 Jan 2021 post vaccination, patient has been tested for COVID-19 test (Curative) and result was unknown. On 27Jan2021 at 15:00, patient experienced muscle stiffness, dizziness, fatigue, diarrhea, headache, fever, pain in arm, ringing in ears, confusion and nausea. Patient did not receive any treatment for the events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
32 2021-05-16 eye swelling, eye itchiness Received second dose of Pfizer at 10:30 AM. 12:30 PM began to experience swelling and itching aro... Read more
Received second dose of Pfizer at 10:30 AM. 12:30 PM began to experience swelling and itching around the left eye. Returned to clinic location and spoke to Dr. volunteer on site. RN spoke with client and client was given 25mg Benadryl PO at 1:40 PM. Client was in no distress. Took Medication, lives 5 minutes away, drove home.
32 2021-05-16 mouth tingling Patient had anaphylaxis reaction to Pfizer ( LOT#: EW0176, EXP date: AUG2021)first dose. Vaccine adm... Read more
Patient had anaphylaxis reaction to Pfizer ( LOT#: EW0176, EXP date: AUG2021)first dose. Vaccine administered around 0855, approximately at 0904 patient reported difficulty breathing and reported it to (observer). Observer brought the patient to a patient care room and reported it to the team lead. Patient appeared flushed, Provider noted that the patient was holding her throat. EpiPen 0.3mL (Lot #0FM355 Exp: NOV2021) was administered at 0910 and held in patients left thigh for 10 seconds. Patient reported a burning sensation when Epipen was given. EMS was called at 0913 arrived at 0922. Patient reported lip tingling and chills after EPiPen was administered. Patient developed a horse like cough but was reporting that her ability to breath was getting better. Vital signs taken at 0908 BP: 124/84 HR:82 O2: 98%. Second Vital signs taken at 0920 BP: 124/84 HR:100 O2: 98%. Third set of vitals taken at 0930 BP: 130/88 HR: 102 SPO2: 98%. Patient transported to Hospital at 0932.
32 2021-05-16 taste disorder Severe aversion to all foods in terms of taste, texture, and smells. I would throw up, experience s... Read more
Severe aversion to all foods in terms of taste, texture, and smells. I would throw up, experience severe nausea, or be unable to taste pretty much any food for about a week. To combat this, I drank water and had meal replacement smoothies/ drinks when I could stand them.
32 2021-05-16 ringing in ears Morning after injection, woke up with overall joint /muscle aches, not feeling well. Six hours later... Read more
Morning after injection, woke up with overall joint /muscle aches, not feeling well. Six hours later, woke up in the night feeling very dizzy, felt like "water was swishing in my head", head pressure, headache, and loss of balance when upright to walk. Symptoms became worse over the next 6 days. Tried taking Dramamine with not much relief. Contacted MD x2 during that week who just encouraged hydration. Contact Dept of Health on day 7,suggesting to complete this form. Was seen by Medical MD on day 8 to document symptoms, attributing to effects caused by receiving 2nd covid vaccine dose. Day 9, full symptoms returned. Day 10, only symptom was headache.
32 2021-05-17 dry throat, dry mouth, mouth tingling Pt reports ~3 hours post-vaccination her left arm was sore and painful, and her legs felt weak. She ... Read more
Pt reports ~3 hours post-vaccination her left arm was sore and painful, and her legs felt weak. She reports that she felt like she was not able to breathe bc her whole mouth and throat got dry, and it felt like her tongue was getting large (but it did not look big, just felt big). She reports that her throat felt ticklish. Pt reports she hyperventilated and had heart palpitations; she had a lot of anxiety and could not sleep for three days. Pt reports she experienced these symptoms for 3 days and all subsided. Pt reports she took Advil Allergy formulation which helped relieve her left shoulder pain only. She also went to the Hospital when she was experiencing these symptom and she was checked out and was told no abnormal findings and was recommend to follow up with MD, pt. states she does not have a PCP.
32 2021-05-17 swollen tongue, eye swelling, mouth swelling Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-M... Read more
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Swelling and tingling occured in tongue, lips and throat. Symptoms began to abate 3-4 minutes after administration of epinepherine (Epineperine 0.3 mg via autoinjector to the pt's left thigh at approximately 1730). Patient was taken to ER by EMS. EMS arrived at approximately 1737.
32 2021-05-18 mouth tingling Vaccination was received on Wednesday afternoon. That Friday night at 11pm I felt tingling around my... Read more
Vaccination was received on Wednesday afternoon. That Friday night at 11pm I felt tingling around my mouth. I developed nausea and lightheadedness/dizziness at about 12:00 am and the tingling became severe itching that spread gradually to the rest of my body without any visible rash, from my scalp down to my knees, slightly less severe on my feet and soles, and lasted some 36 hours. I visited an emergency center Saturday morning due to extreme discomfort and received a steroid injection and hydroxyzine HCl tablets. Itching continued through the rest of the day and gradually diminished, ending by Sunday mid afternoon.
32 2021-05-19 mouth numbness, taste impairment, mouth itchiness, tongue itchiness her period is now 11 days late; tired; stabbing shocks in her chest (chest pain) that lasted for 3 h... Read more
her period is now 11 days late; tired; stabbing shocks in her chest (chest pain) that lasted for 3 hours; heart started to pound; she had a metallic taste in her mouth; face was numb and warm; face was numb and warm; heart rate at 160 bpm; her mouth/tongue felt itchy; her mouth/tongue felt itchy; throat felt itchy; lips numb; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 28Jan2021 16:00 (lot number: EL3247) at the age of 32 years old, as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included asthma from 3 years, allergies (all her life), Chiari malformation from 10 years, vocal cord dysfunction from 3 years, Vitamin D low, constipation and Ferritin low. Concomitant medications included albuterol [salbutamol] (ALBUTEROL) taken for asthma; clarithromycin (CLARITIN) taken for allergies; iron taken for ferritin low; magnesium taken for constipation; and vitamin d [vitamin d nos] (VITAMIN D) taken for Vitamin D low; all taken from an unspecified start date and ongoing. The patient reported she had the first dose of the Pfizer COVID 19 vaccine on 28Jan2021 at 16:00PM in the left arm. About 10 minutes into her wait period (28Jan2021), her heart started to pound; her lips numb and face went numb and warm; she had metallic taste in her mouth; and her mouth/tongue and throat felt itchy. She went up to the nurse to tell her about her symptoms and they hooked her up to an O2 monitor that showed her heart rate at 160 beats per minute but her 02 was okay, it was not under 97%. She was given a generic form of Zyrtec. They monitored her for an hour and her heart pounding stopped. The metallic taste was very brief, and lips and face numbness, and mouth and throat felt itchy all resolved that same day. The next day (29Jan2021), she was tired. Then about 50 hours after the shot, in the night on the 29Jan2021 to 30Jan2021 she started getting weird stabbing shocks in her chest (chest pain) that lasted 3 hours. She would wake up with the pain and then fall back to sleep. It happened several times for a few hours then went away. Lastly, she added that she never ever misses her period but now she is two weeks late (also reported as 11 days late) and she is not pregnant. She expected her period to start on 02Feb2021. She did visit her allergist before getting the vaccine and he said none of her allergies were related to any of the ingredients in the shot. Then she saw the allergist again after the shot and the allergist didn't think she needed to be concerned as the allergist said her symptoms are not in line with an anaphylactic reaction. She is planning to receive the second dose of the vaccine on 18Feb2021. Outcome of the event 'stabbing shocks in her chest (chest pain)' was recovered on 30Jan2021. Outcome of 'her period is now 11 days late' was recovered on unspecified date. Outcome of tired was recovered on 29Jan2021, while outcome of the remaining events was recovered on 28Jan2021.
32 2021-05-19 lip blister A blister on the temple of the face burst, leaking a lot of yellow fluid on 4/29/21. Over the next c... Read more
A blister on the temple of the face burst, leaking a lot of yellow fluid on 4/29/21. Over the next couple of days, the blister expanded and a few more blisters formed on the forehead and neck . Yellow fluid would seep out and crust on the skin. Over the subsequent 2 weeks, almost entire face went red, excretes out yellow fluid that forms crust over the face. Upon receiving oral broad spectrum antibiotic, face started to swell. At the same time, very itchy pimple-like rash started spreading on arms and torso. Some parts of the rash eventually form blisters that looked similar to the original on the temple, and leaked some yellow fluid, though much less intense in color and volume.
32 2021-05-20 blindness transient Patient reported dizziness with vision loss (partial and temporary). Patient reported to be Brady f... Read more
Patient reported dizziness with vision loss (partial and temporary). Patient reported to be Brady for 4-5 minutes. HR increased. Patient went to bathroom and c/o cramping, diaphoresis noted but symptoms resolved.
32 2021-05-21 ringing in ears Increased sound of ringing in left ear, continuous.
32 2021-05-22 ear discomfort, ringing in ears Ringing, burning and pressure in my ears.
32 2021-05-22 visual impairment Subjective SOB, vision changes, resolved in 30-60 minutes, started 20 minutes after vaccine. Tolerat... Read more
Subjective SOB, vision changes, resolved in 30-60 minutes, started 20 minutes after vaccine. Tolerated second dose.
32 2021-05-23 visual impairment Headache, parathesias, visual disturbances, neurological impairments
32 2021-05-24 dry mouth, dry eye, swollen lips Burning/blistering rash developed abruptly on left arm, chest, lower legs and right arm that has con... Read more
Burning/blistering rash developed abruptly on left arm, chest, lower legs and right arm that has continued to spread to entire body including lips and inside of nose. Numbness in hands and feet. Notes from all medical visits below. 5/17/2021 Walk-In. Patient present with a worsening rash x today. She received her second Pfizer COVID vaccine on 5/14. Patient reports a small rash at the vaccine site that evening. No worsening of rash over the weekend. Patient denies fevers, HA, ST, dyspnea. She reports a history of skin sensitivities. No new soaps, lotions or detergents. No new medications or supplements. No itching or pain from rash. She reports that her symptoms started with small, clear, "bubbles", then turn into flat, excoriated erythema. 5/19/2021 SMHC ER. 32 y.o. woman presenting with a rash. Patient had her second COVID-19 vaccine on 5-14. On 5-17 started developing a rash over her left arm at the site of the vaccine. Started with clear bubbles, that then look excoriated. She reports that they feel like they are burning. They have since spread to her chest and her back, her legs, her arms. She has put a little bit of antibiotic ointment on some of them, but this has not helped. No painful urination. Does report her eyes and her mouth feel dry. 5/19/2021 Dermatology Pt arrived from the ER admitting to significant fatigue. The burning in her skin has an abrupt onset which wakes her from sleep. She notes that starting Saturday 5/15 she has had intermittent pins and needles in her hands and feet. As of today her right foot is becoming more numb. She also notes the onset of burning at the left inside of her mouth. 5/20/2021 Dermatology. Assessment and Plan: 1. Neoplasm of uncertain behavior of skin. 32F with vesicular - petechial eruption with secondary crusting at trunk and extremities s/p 2nd Pfizer COVID-19 Vaccine on 5/14/21. Vasculitis vs DIC vs Stevens Johnson syndrome/ TENS in pt with symptoms consistent with coronavirus infection despite vaccination. SURGICAL PATHOLOGY TISSUE SPECIMEN; pending. Skin biopsies sent urgently on 5/19/21 for H&E and DIF. Prednisone started 5/19/2021 in ER: 60mg x3 d, 50mg x 3 d, 40mg x3 d, 30mg x3 d, 20mg x3 d, 10mg x 3 d (18 day taper). Out of concern for possible vasculitis compromise of the pt's kidneys I prescribed bleach baths and topical mupirocin oint rather than add systemic antibiotics for secondary infection of lesions. Given the worrisome and worsening presentation, the pt and her husband agree to present to the E.R. They declined transport by ambulance and will go to the E.R. now. Number and Complexity of Problems Addressed. 1 acute or chronic illness or injury that poses a threat to life or bodily function. Mild headache last evening, no blurry vision. Extreme fatigue with effort of getting up and getting dressed Interrupted sleep with persistent burning pains at LEs, pins and needles at hands and feet and worsening blue discoloration at LEs and numbness at 2nd & 3rd rt toes. Has been able to hydrate; urine light yellow. Appetite maintained but no stool since 5/17. Pt removed IV from rt antecubital which had been left by E.R. 5/20/2021 ER. This is a 32 y.o. female with a rash that initially developed over her injection site from her second COVID vaccine received 6 days ago. The rash begins as bubbles and then appears excoriated. Described as burning and have since spread to her chest, back, legs and arms. She was evaluated yesterday at SMHC ED and Dermatology. Placed on 60 mg Prednisone and admits that the pain has not really improved. Sent here today for concern of DIC/Vasculitis/SJS. Patient well appearing, VSS. Will repeat labs, provide 1 L NACL and Oxycodone for pain. Had today's dose of Prednisone. Does have decreased DP pulses, foot mottling and decreased capillary refill. Will obtain bilateral arterial US. Discussed with Dr. who also evaluated the patient and is in agreement. Labs improved from yesterday, only mild elevation of D-dimer. Some protein in her urine. Repeat evaluation after keeping her legs covered reveals normal cap refill less than 2 seconds. Still mottled and unable to palpate DP pulses bilaterally. 5/21/2021 Assessment. Prescribed Ondansetron Hydrochloride 4 mg For nausea.
32 2021-05-25 lip swelling Swelling of the lips with no other allergic reaction. Not sure if it developed after the first or se... Read more
Swelling of the lips with no other allergic reaction. Not sure if it developed after the first or second vaccine shot. Went to urgent care. Put on prednisone steroid. Helped a tiny bit but still noctieable. Swelling came back after a few days of finishing the prednisone steroids. Went back to urgent care. Prescribed a topical dental paste for mouth. Hasn?t really helped. It is still swollen after 6 weeks and ongoing
32 2021-05-26 ear discomfort Ear pressure ever since vaccine, causes dizziness
32 2021-05-27 taste impairment Metallic taste in mouth
32 2021-05-29 vision blurred Patient received first dose of Pfizer vaccine. She indicated she fainted after receiving some inject... Read more
Patient received first dose of Pfizer vaccine. She indicated she fainted after receiving some injectable during an ER visit once but she did not know the medication. She mentioned she was lactating. She was told to wait 30 minutes in the area after receiving the vaccine. Patient fainted at 11:33am, she indicated she experienced blurry vision, some dizziness and fainted. Associate indicated patient body got rigid before fainting. Patient was put in the floor, legs were elevated and gained consciousness slowly after a few seconds. She was accompanied by her husband. Code White was announced. Ambulance was called. Pharmacy Associate went to the area and took notes; patient was transferred to a chair. I went there, blood pressure was 136/91. She told me she was feeling a little better. Pharmacy Assistant came and did the report. Verified blood pressure again, was 114/88 before I went back to the pharmacy. She was better. Ambulance came at 11:59 am. Emergency Techs showed. Blood pressure was 110/88 and Blood Glucose 93. Patient decided to go to the Hospital in ambulance to make sure everything was normal.
32 2021-06-01 taste impairment Patient suffered vertigo, dysequilibrium leading to fall risk, relapse of anxiety disorder, relapse ... Read more
Patient suffered vertigo, dysequilibrium leading to fall risk, relapse of anxiety disorder, relapse of formerly-improved post-COVID sx (dysgeusia, nausea), and suffers from migratory arthralgias.
32 2021-06-01 ear pain about 3 hours after shot, experienced severe vertigo and dizziness, causing nausea. 36 hours later s... Read more
about 3 hours after shot, experienced severe vertigo and dizziness, causing nausea. 36 hours later still moderate dizziness and occasionally extreme dizziness. no treatment except rest. also moderate pain in left ear beginning 12 hours after shot.
32 2021-06-01 smell distorsion, taste disorder have a smell and taste of decaying fruit; have a smell and taste of decaying fruit; This is a sponta... Read more
have a smell and taste of decaying fruit; have a smell and taste of decaying fruit; This is a spontaneous report from a contactable consumer reported for herself. A 32-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (vaccination at the age of 32 years) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unknown date for covid-19 immunization. The patient reported that she had both doses of the Pfizer COVID Vaccine. After the second dose, she reported to have a smell and taste of decaying fruit on unknown date. She wants to know if other people have reported that as a side effect and if there is anything she must do. The outcome of the events was unknown. Information on the lot/batch number has been requested.
32 2021-06-01 vision blurred I have not had any issues with my pregnancy. My expected date of delivery is 07/09/2021. My adverse ... Read more
I have not had any issues with my pregnancy. My expected date of delivery is 07/09/2021. My adverse event occurred two days after I received my second dose. I woke up and couldn't really see. I had vision, but I couldn't see clearly. I did not have any other side effect though. I went to my OBGYN because they weren't sure if it was onset of rapid pre-eclampsia. They ruled that out and told me to go home and rest. The vision issue only lasted the day after I received my vaccine. The morning after my event, everything was fine. My doctor said that it may have been a "not typical" migraine.
32 2021-06-07 conjunctivitis Pityriasis rosea, triamcinolone acetonide, ongoing mucopurulent conjunctivitis, right eye, polymyx... Read more
Pityriasis rosea, triamcinolone acetonide, ongoing mucopurulent conjunctivitis, right eye, polymyxin B-trimethoprim ophthalmic 10000 units-1 mg/mL ophthalmic solution, 10 days
32 2021-06-07 mouth numbness Patient's stated her lips, throat and tongue felt numb (like she'd eaten a popsicle stick she descri... Read more
Patient's stated her lips, throat and tongue felt numb (like she'd eaten a popsicle stick she described). her hands were also numb. her face and chest were flushed and had hives. She stated feeling like she was going to pass out. She was able to talk but was taking deep breaths. She wanted to wait for a few minutes before we administered EpiPen as she was starting to feel better. Emergency services was called and evaluated her. As her condition was improving well, they advised her to take Benadryl and seek emergency care if symptoms worsened.
32 2021-06-09 eye movement disorder Patients daughter stated, " something is wrong with my mother". RN assessed patient, patient was pal... Read more
Patients daughter stated, " something is wrong with my mother". RN assessed patient, patient was pale, diaphoretic, eyes rolled back. Patient was layed on the floor and legs were placed on chair. Patients vitals are : BP 128/75. HR 76, Spo2 99%. Syncope lasted around 30 seconds. RN did a sternal rub and patient came back. Patient was oriented to person and place, Patient was given an orange and ambulance arrived. Patient was taken to hospital.
32 2021-06-10 swollen tongue extreme fatigue, brain fog, body aches, swelling at the injection site, swelling of tongue, difficul... Read more
extreme fatigue, brain fog, body aches, swelling at the injection site, swelling of tongue, difficulty speaking, memory loss day after, constant need to sleep and lapse of memory, weakness
32 2021-06-12 swelling around the eyes Generalized rashes with goosebump characteristics to upper extremities; hives/rashes to face, and ne... Read more
Generalized rashes with goosebump characteristics to upper extremities; hives/rashes to face, and neck. Developed rashes resembling eczema with weeping to top of hands bilaterally. Swollen eyes to periorbital area.
32 2021-06-14 lip swelling Developed syncope after vaccination and fell to floor. History of near syncope with blood draws. L... Read more
Developed syncope after vaccination and fell to floor. History of near syncope with blood draws. Later developed swollen upper lip.. Unclear if due to allergic reaction or traumatic when fell to the floor. No rash, shortness of breath, throat tightness. Felt light-headed with some nausea. Symptoms resolved without treatment.
32 2021-06-18 ear pain This spontaneous report from a contactable nurse (patient) via Medical Information Team reporting sa... Read more
This spontaneous report from a contactable nurse (patient) via Medical Information Team reporting same events under the same suspect product for six patients. This is one of six reports. This Nurse reported for a patient in response to HCP letter sent via follow-up letter. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EW0191) via an unspecified route of administration to left arm on 20May2021 9:16 AM as single dose for COVID-19 immunization. Patient age at time of vaccinations: 32 year. The patient's medical history included acute swimmers ear infection since 19May2021, ongoing fibromyalgia and history of migraines. Family medical history relevant to AE(s): None. Concomitant medications included tizanidine hydrochloride (ZANAFLEX) daily, sertraline hydrochloride (ZOLOFT) daily, meloxicam (MOBIC) and gabapentin (NEURONTIN). Prior Vaccinations within 4 weeks: None. The patient received full vial or full doses of the Pfizer COVID vaccine on an unspecified date. Caller was a Registered Nurse and a Clinic Manager at a Medical facility. They had a dosage error involving 6 patients. The 6 Patients received full vial or 6 doses each of the Pfizer COVID-19 Vaccine. Patients were 12, 16, 17, 18 and 32 years old and still waiting for additional information of the last patient. She did not have data on the genders of the patients. She agreed to be called back for additional AE reporting. Patient called on 20May2021 at 17:20 PM night and reported dizziness. Patient did not require any additional treatment or seek medical care. On 21May2021, patient had temperature of 101.2, but still had the swimmers ear infection that was diagnosed on 19May2021. She reported poor sleep, low appetite, pain all over, dizziness, and was likely dehydrated. 25May2021 she was still having ear pain from swimmer's ear infection, and also was experiencing muscle spasms. Outcome of the events she was still having ear pain from swimmer's ear infection and muscle spasms was not recovered, whereas other events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021575812 Same reporter/product/event, different patient
32 2021-06-19 vision blurred On 16th of June 2021, I was at the employee health to receive my first dose of covid vaccine, the nu... Read more
On 16th of June 2021, I was at the employee health to receive my first dose of covid vaccine, the nurse administer me the first dose on my right arm and told me to go sit at the waiting area and gave me timer for 15mins. At exactly 5mins into it, I began to feel tightness, palpitation and pain in my left chest , then I stood up to alert the nurse for help and my vision went blurry and dizziness, so I was about to fall, and the nurse grabbed me and took me to a room and she check my blood pressure and alerted the physician on duty and I was wheeled to the emergency room for further evaluation. at the emergency room they did EKG 12 lead, XR chest PA and lateral , and some labs.
32 2021-06-20 ear infection I had sinus infection, I had respiratory infection and double ear infection (Inner and Outer) and ra... Read more
I had sinus infection, I had respiratory infection and double ear infection (Inner and Outer) and ran a fever for 1 week. I went to Urgent Care twice, the first time they gave a prescription for the ear infection. After the second time I got another prescription, and everything was better. No need to see a doctor again.
32 2021-06-21 hearing loss Following Symptoms began and ended around the same time 12:24pm 5 min long Dizziness/feeling of fa... Read more
Following Symptoms began and ended around the same time 12:24pm 5 min long Dizziness/feeling of fainting Lowered ability to hear Chills/sweating Nausea
32 2021-06-22 blindness It started with a retinal migraine which I have never gotten before, then I lost my vision. My anxie... Read more
It started with a retinal migraine which I have never gotten before, then I lost my vision. My anxiety took over and I started to panic. I went to the emergency room where they tested me for having covid-19 which was negative. I lost the feeling on the right side of my body. I felt extremely nauseated and weak. I became very flush and pale while having cold sweats. This lasted 4 hours. After this I was just weak the rest of the day. This happened two times to me. Both on normal days where I was supposed to be working. Luckily I work in the clinic. The dates this happened where on 03/18/2021 and 03/26/2021 both in the morning.
32 2021-06-24 oropharyngeal discomfort patient was given shot in immunization room, then was in waiting room to wait the required 15 minute... Read more
patient was given shot in immunization room, then was in waiting room to wait the required 15 minutes.. she then began to have panic like symptoms and stated her throat felt funny and was having trouble breathing, the technician came and got myself, pharmacist,, she was already laying on the floor.. I assessed her and she stated the same, that she feels like she is having a panic attack and throat feels funny. I placed a tote under her feet to elevate her legs while she is in the supine position. I explained to her that I need to give her an Epi pen and she then said no, and stated this often happens when she receives shots or sees blood and that she is just having a panic attack. She then stated her breathing is fine and that her throat is fine too. She wanted to leave and I insisted she stay 30 minutes to continue to evaluate her. She agreed too. She did not receive the EpiPen because she was completely recovered and it was a panic attack not anaphylaxis. After 30 minutes she was completely fine, I gave patient my cell # to call me once she was home. She called me once home and was completely fine.
32 2021-06-29 taste impairment Chemical taste in the back of throat taste of vaccine; This is a spontaneous report received from a ... Read more
Chemical taste in the back of throat taste of vaccine; This is a spontaneous report received from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration on the left arm on 18Mar2021 at 15:45 (at the age of 32-year-old), as single dose for COVID-19 immunisation. Medical history included celiac. The patient has allergic to latex. Concomitant medication included tramadol (MANUFACTURER UNKNWON) and multivitamin ritual (MANUFACTURER UNKNOWN) from an unknown date and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration on the left arm on 22Feb2021 at 15:00, as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested positive for COVID-19. On 18Mar2021 at 16:00 (for 2 hours after second dose), the patient experienced chemical taste in the back of throat taste of vaccine. On the following day, the patient had the same feeling which went away quickly. The patient described the event as it was similar to when she swallows a pill and it gets stuck or had not enough water. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event chemical taste was resolved on 19Mar2021. No follow-up attempts possible. No further information expected.
32 2021-06-29 eye swelling Swelling of skin between the eyes, starting with left eye. Lasting 2 days
32 2021-06-29 mouth ulceration, mouth pain mild flu-like symptoms; Mouth sores/ulcers; Mouth sores/ulcers; This is a spontaneous report from a ... Read more
mild flu-like symptoms; Mouth sores/ulcers; Mouth sores/ulcers; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) intramuscularly on 03Feb2021 07:15 AM in left arm as dose 2 single for COVID-19 immunization at Hospital. Medical history and Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE) intramuscularly in left arm on 13Jan2021 08:00 AM (at age of 32-year-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. It was reported that patient experienced mild flu-like symptoms, mouth sores/ulcers on 04Feb2021. No treatment received for the adverse events. The outcome of events was unknown. Information on the lot/batch number has been requested.
32 2021-07-01 hearing loss I woke up with severe hearing distortion in my left ear.; This is a spontaneous report from a contac... Read more
I woke up with severe hearing distortion in my left ear.; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non pregnant (including at the time of vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 27May2021 09:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization at the Pharmacy or Drug Store. Medical history reported as none and there were no concomitant medications. On 17Jun2021 05:45, the patient woke up with severe hearing distortion in her left ear. She made a doctor or other healthcare professional office/clinic visit and received steroids as treatment. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. Outcome of the event was not recovered. Information about lot/batch number has been requested.
32 2021-07-05 eye swelling, lip swelling itching behind ears and head on 07/01/2021, hives appeared on 07/02/2021 , swelling of lips 07/02/20... Read more
itching behind ears and head on 07/01/2021, hives appeared on 07/02/2021 , swelling of lips 07/02/2021. went to hospital was given IV Benadryl and histamines, pepcid, and epi pen for emergency, discharged on 07/03/2021 with medrol dose pack and pepcid and OTC Benadryl, on 07/03/2021 evening rash intensified all over body, itching increased, woke up sunday 07/04/2021 both eyes swollen. went back to the hospital was given more IV Benadryl and increased mg of prednisone at 60mg daily. woke up monday with rash still present. seen pcp on 07/06 and was referred to a allergist due to body being covered and prednisone not working.
32 2021-07-09 vision blurred Started having headaches, hypertension with blurry vision. Had MRI which showed diffuse FLAIR/T2 sig... Read more
Started having headaches, hypertension with blurry vision. Had MRI which showed diffuse FLAIR/T2 signal changes subcortically-> brainstem-> c spine. Ongoing work-up but thus far negative for malignancy, autoimmune process, toxidrome, infection.
32 2021-07-11 dry eye, eye strain 5/9 PM: heart palpitations, chest pressure and left chest pains developed. BP went up to 140/99 and ... Read more
5/9 PM: heart palpitations, chest pressure and left chest pains developed. BP went up to 140/99 and stayed high, heart rate normal, had loose stool/diarrhea throughout evening. Difficulty sleeping because of discomfort and anxiety over discomfort. First day of my placebo week for hormonal birth control. 5/10: Loose stool, pressure and discomfort continued throughout day, sore arm/armpit, shortness of breath when doing simple daily tasks (walking around apartment, going up a flight of stairs). Very fatigued, low energy, low appetite. 5/11: Headache developed, BP 132/98, had telehealth appt with PCP and was advised to admit myself to emergency room. All tests came back normal, I was told that ER doctor had seen 30-40 patients who felt very ill after second vaccine but that over a week they started to feel better. - continued feeling symptoms throughout week, slept 18+ hours a day, incredibly tired, no appetite, headaches, loose bowel movements, chest discomfort- 5/17: Appetite has slightly improved, bowel movements improved but not entirely back to normal, BP still high (132/94), pressure and fogginess in head, dry cough develops (coughing once every ten minutes or so), mid back around spine is very sore, neck feels sore as if head is too heavy, fatigue has improved and I'm able to stay awake all day, eyes feel very tired and dry, left armpit and left breast are very sore. Had a previous knee discomfort in 2020 but had gone to PT and recovered 100%, but suddenly right knee has a dull aching/pain like it did prior to physical therapy (hadn't felt discomfort in it since finishing PT 11/2020) 5/18: went to PCP to discuss symptoms, was told I was having a robust reaction to vaccine. PCP attributed coughing to allergies and told me to use Flonase and take Tylenol for headaches, PCP anticipated I would feel better in another 2-3 weeks. Was prescribed 10 mg of Propranolol 2x a day for high BP and anxious feeling 5/19: first solid bowel movement since vaccination, energy level is good, noticed an improvement in shortness of breath 5/20: chest discomfort/shortness of breath when carrying laundry to laundry room, sore neck and sore mid-back, armpit and left breast still sore 5/21: armpit, left breast, back and neck still sore, cough continues, chest discomfort continues 5/24: everything is still sore, chest pressure was better during the day but suddenly felt fluttery/palpitations at night out of nowhere 5/25: sore back, armpit and breast, coughing, endurance while doing laundry was good, in evening left breast was very sore and felt anxious/chest pressure 5/26: outside of left ankle is sore, mid/upper back sore, left boob sore, fluttery chest feeling in evening 5/29: tightness in chest, couldn't take a deep inhale, still coughing 5/30: very sore left breast, swollen left lymph node in throat, coughing, sore neck. Flonase doesn't seem to helping cough at all. 6/4: chest pressure in evening, felt like my breaths were deep even though I was just sitting on couch, still coughing, neck, back and breast continue to be sore. 6/6: first day of placebo week on hormonal birth control 6/10: took a Tylenol extra strength before bed for headache, woke up in middle of night and had significantly worse chest pain and palpitations. Also had shivers and BP was higher than it had been since going on Propranolol (137/97). 6/11: shortness of breath when talking, severe fatigue, chest pain and palpitations continued throughout day, felt very anxious. No appetite. Got tested for COVID at local pharmacy and tested negative. Cough continues. Had phone call with PCP and was advised to double Propranolol dosage to lower BP and help with anxiety. 6/12: very fatigued, slept most of day, no appetite, loose stool/diarrhea, coughing. BP was 128/90 in evening. 6/13: very fatigued, slept most of day, loose stool, no appetite, coughing. Went back to normal dosage of Propranolol because i was curious if the double dosage was worsening my fatigue and loss of appetite. BP was 126/88. 6/14: feeling slightly better, still have chest pressure, headache, fatigue, right knee is still bothering me. 6/18: fatigue/fogginess throughout day, low appetite but it's improving. right knee still bothering me. felt very panicked/fluttery in chest in evening and didn't feel I could go to the grocery store. BP was 115/80. 6/22: saw cardiologist for first time, he ordered an MRI and a health monitor patch. we spoke about potential inflammation issues and he suggested I go on a Motrin routine to see if that helps, as there are no adverse effects to taking it. This evening I took 400 mg of Motrin, and began taking 400 mg every morning and night. Scheduled follow-up cardio appt for 7/13. 6/25: good energy level, didn't need to nap. watched a scary movie and didn't feel any palpitations or pressure (previously I'd feel increased discomfort and pressure when stressed/scared since getting vaccinated). 6/26: solid stool, good energy level, cough seems lighter, good appetite 6/27: some slight chest pressure during day, solid stool, felt fluttery late at night, cough was worse than earlier in the day. in general didn't feel as good as last couple of days. BP was 115/70 in evening. 6/29: good energy and appetite, some coughing, noticed my knee isn't bothering me as much now. 6/30: very tired in morning, some fluttery chest feelings after getting up, knee discomfort is gone. 7/3: appetite and bowel movements have been good, good energy levels, some chest pressure/shortness of breath while standing in line at post office. incredibly sore boobs (about to start period, but they're even more sore than usual for this time of month). BP was 118/80 at night. 7/4: good energy level, not much coughing at all, first day of placebo week for birth control. 7/5: great energy level and appetite, had a very busy and long day and felt great throughout. 7/6: felt pretty tired today, started period. was in bed in evening and suddenly felt shortness of breath, some chest pressure. checked BP and it was high again (140/90). Had loose stool/diarrhea three times in a row at night after starting to feel chest pressure, continued to feel anxious/palpitations/pressure and felt shivery, noticed an increase in coughing. This is almost four weeks to the day of my last bad night when I had same symptoms, only this time the symptoms were less severe. On period both times, wondering if this has anything to do with it. 7/7: loose stool first thing in morning, feeling very disappointed that I had a bad chest episode the night before as it seemed that the Motrin routine had been working, but suddenly feeling bad again. Napped most of afternoon, slight chest pressure throughout day, but decent energy level and don't feel nearly as exhausted as I did on the day following my previous chest episode. Noticed my knee is bothering me again. 7/8: shortness of breath, very sore mid back, decent appetite, fatigue. Got MRI today. 7/10: some fatigue and palpitations but had an active day and was able to stay awake the whole time, had a decent appetite Currently awaiting cardio follow-up appt
32 2021-07-11 mouth swelling, swollen tongue, bloodshot eyes, eye swelling Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: patient repor... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: patient reported redness in her eyes, and went to urgent care and noted inflammation and prescribed steriod eye drop for redness which helped with redness.
32 2021-07-13 loss of taste, loss of smell Vaccinated by Pfizer on 3/1/20 and 3/22/21. Symptom onset 7/1/21 with cough, runny nose, muscle ac... Read more
Vaccinated by Pfizer on 3/1/20 and 3/22/21. Symptom onset 7/1/21 with cough, runny nose, muscle aches, loss of smell, loss of taste, sore throat, nasal congestion, headache,, fatigue. Tested positive for Covid-19.
32 2021-07-13 loss of taste, loss of smell Vaccinated with Pfizer on 3/1/21 and 3/22/21. Symptom onset 7/1/21 - cough, runny nose, muscle ach... Read more
Vaccinated with Pfizer on 3/1/21 and 3/22/21. Symptom onset 7/1/21 - cough, runny nose, muscle aches, loss of smell and taste, sore throat, nasal congestion headache and fatigue. Tested positive for Covid19 on 7/13/21.
32 2021-07-15 deafness Site: Pain at Injection Site-Medium, Additional Details: Patient reports hearing loss. Doesn't know ... Read more
Site: Pain at Injection Site-Medium, Additional Details: Patient reports hearing loss. Doesn't know if related. Was made worse with home remedies - lead to hosp Due to CFS they do usually knock her out harder. Also reports chronic fatigue syndrome
32 2021-07-17 eye discomfort This is a spontaneous report from a contactable consumer or other non hcp (patient) reporting hersel... Read more
This is a spontaneous report from a contactable consumer or other non hcp (patient) reporting herself. A 32-year-old female patient received BNT162B2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Left upper Arm on 11May2021 18:30 (at the age of 32-years-old) (Batch/Lot Number: EW0170) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing systemic lupus erythematosus diagnosed since age 16, about 14 years ago they think it spiked around age 14 but it was not diagnosed until age 16 , ongoing Ehlers-Danlos syndrome started around age 18 or 19 She has had it her whole life and they didn't know what was going on with her but was diagnosed at age 18 or 19 , ongoing fibromyalgia Since age 16 , ongoing colitis ulcerative around age 16 , ongoing migraine age 16 to 18 , ongoing tachycardia diagnosed age 24 or 25 but thinks it started with lupus , ongoing narcolepsy diagnosed around age 23 or 24 , ongoing raynaud's phenomenon diagnosed around age 16 , ongoing sjogren's syndrome diagnosed around age 16. Concomitant medications included hydroxyzine pamoate (HYDROXYZINE PAMOATE) taken for sleep apnoea syndrome, feeling of relaxation from an unspecified start date and ongoing; tramadol (TRAMADOL) taken for pain from an unspecified start date and ongoing; cyclobenzaprine (CYCLOBENZAPRINE) taken for muscle relaxant therapy from an unspecified start date and ongoing; methotrexate (METHOTREXATE) taken for immunosuppressant drug therapy from an unspecified start date to 20Apr2021; prednisone (PREDNISONE) taken for inflammation from an unspecified start date to 20Jun2021. While providing concomitant medications, caller states she had been on high doses of Prednisone since this to get the inflammation off her brain. She stated she had been on again and off again to get the inflammation off of her brain. Caller does not have NDC/Lot/Exp for prednisone. Product strength: Take tablets by mouth: 80mg for 2-3 days then 60mg for a couple of days then 40mg for 1 day then 20 then 10 then off. count size dispensed: not provided Is a sample of the product available to be returned, if requested (Y/N): not provided Packaging sealed and intact or not provided. The patient previously bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Left upper Arm on 20Apr2021 (at the age of 32-years-old) (Batch/Lot Number: ER8731) as DOSE 1, SINGLE for covid-19 immunisation. The patient stated that she had horrible, horrific side effects. Caller states she hallucinated for four days (on 11May2021), brain was so swollen it wasn't getting oxygen to it (on 11May2021). On 11May2021, patient spikes with blood pressure and visuals all over again. On 12May2021, patient pretty sure she died and met angel. She had a rare autoimmune and rare genetic disorder called Ehlers Danlos Syndrome. "They" thought it might be the trigger - they said they've never heard of it. It took her a week before getting to ER. They gave her a counter inflammation medication to get swelling off brain. She experienced brain damage on an unspecified date. They did two doses of Benadryl then a cocktail the second time around. She knew the cocktail was Benadryl and throw up medicine and something else. Then she got hives all over her body (on 26May2021). She still had hives almost a month later and was still having bad migraines (on 26May2021) and everything was inflamed. Caller had Lupus and was finally for the first time in 32 years in remission before the shot and now everything had started (on on 26May2021). On an unspecified date, patient laid in bed, gasping for air, and blacked out. Caller states she was really really really sick, headaches and high fevers. She mentioned her joints ached. She now had blood in her urine again. She did something with activity that made heart rate go up and hallucinate. The patient underwent lab tests and procedures which included blood test: unknown on 25Jun2021. The outcome of events hallucinated for four days, brain was so swollen wasn't getting oxygen to it was recovered 14May2021, spikes with blood pressure and visuals all over again and having bad migraines recovered on an unspecified date in May2021. The outcome of got hives all over body was not recovered while outcome of rest event was unknown.
32 2021-07-17 tongue itchiness, taste impairment Itching all over; Itching increased to a burning; Minor chest burning; Tongue/throat itching; Tongue... Read more
Itching all over; Itching increased to a burning; Minor chest burning; Tongue/throat itching; Tongue/throat itching; A metallic taste in the mouth; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A 32-year-old non pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot Number: ER8727) via an unspecified route of administration in arm Left on 22Mar2021 09:30 as dose 1, single at the age of 32 year for COVID-19 immunisation. Medical history included migraines, allergies to pineapples, nickel, from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, 09:45 AM 15 minutes after injection, patient experienced itching all over and a metallic taste in the mouth. Received a steroid shot that same day because itching increased to a burning and tongue/throat itching. As of today, five days after injection, I am still experiencing the same symptoms itching all over, occasional tongue, throat itching, minor chest burning. Treatment received was asteroid shot/steroid prescription/referral. Prescription of steroids and Benadryl stopped working. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event was not resolved. No follow-up attempts are possible. No further information is expected.
32 2021-07-17 visual impairment, deafness Extreme heat, sweating, light-headedness, black spots/sight going, buckled knees, hearing gone in le... Read more
Extreme heat, sweating, light-headedness, black spots/sight going, buckled knees, hearing gone in left ear and then both ears, unconsciousness-- told husband when I began sweating and getting light-headedness, he held my body weight and helped me to the ground safely, friend held my head, husband lifted legs until I regained consciousness, help escort me to a place I could sit down, EMT provided cold water bottle to wrists, cold cloth was provided, sat with legs elevated until feeling stable
32 2021-07-19 taste impairment, taste disorder, loss of taste Within 3 hours of the first shot I started to feel like I was having burning menstrual cramps in my ... Read more
Within 3 hours of the first shot I started to feel like I was having burning menstrual cramps in my abdomen along with feeling like I might have diarrhea. I haven't had a period or period symptoms in over six years since I am on birth control. Right after those symptoms, almost 4 hours after, I began to feel like I was high for about 3 to 4 hours that feeling lasted. I was still able to concentrate but felt pretty high. A small symptom from the 2nd vaccine that didn't last long and happened within about 20 hours was the taste of chalk when I ate food. I couldn't taste my breakfast or coffee it just tasted like chalk. That went away by lunch at around noon.
32 2021-07-21 eye swelling Post- vaccine allergic reaction. Swelling of the face and right eye, same day of vaccine tingling, s... Read more
Post- vaccine allergic reaction. Swelling of the face and right eye, same day of vaccine tingling, shortness of breath, body aches, general malaise, stomach pain, headache.
32 2021-07-21 lip swelling Extremely swollen lips the day after vaccination.; This is a spontaneous report from a contactable c... Read more
Extremely swollen lips the day after vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Mar2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included dermal filler injection; the patient had dermal filler in her lips, the last procedure had done was in early Feb2020. The patient did not have any allergies to medications, food, or other products. The patient did not receive concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021 at 14:00, the day after vaccination, the patient experienced extremely swollen lips. The events did not result in doctor or other healthcare professional office/clinic visit/emergency room visit. No therapeutic measures were taken as a result of event extremely swollen lips. The clinical outcome of the event extremely swollen lips was recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
32 2021-07-27 ear pain Pt is a 33 year old ( DOB: 1988-04-15 ) female who initiated a e-visit for COVID-19 (Coronavirus) ev... Read more
Pt is a 33 year old ( DOB: 1988-04-15 ) female who initiated a e-visit for COVID-19 (Coronavirus) evaluation and screening. PT states her symptoms started 1-2 days ago. Her symptoms consist of myalgia, malaise, a cough, facial pain or pressure, nasal congestion, a sore throat, ear pain, a headache, chills, and diarrhea. PT also feels feverish. Symptom details Nasal secretions: The color of her mucus is clear. Cough:Pt coughs a few times an hour and her cough is not more bothersome at night. Phlegm does not come into her throat when she coughs. She believes her cough is caused by post-nasal drip. Sore throat: Pt reports having moderate throat pain (4-6 on a 10 point pain scale), does not have exudate on her tonsils, and can swallow liquids. She is not sure if the lymph nodes in her neck are enlarged. A rash has not appeared on the skin since the sore throat started. Temperature: Her current temperature is 102.7 degrees Fahrenheit. Pt has had a temperature over 100 degrees Fahrenheit for 1-2 days. Facial pain or pressure: The facial pain or pressure feels worse when bending over or leaning forward. Headache: She states the headache is moderate (4-6 on a 10 point pain scale). Pt denies having anosmia, rhinitis, teeth pain, ageusia, vomiting, nausea, and wheezing. She also denies having a sinus infection within the past year, having recent facial or sinus surgery in the past 60 days, and taking antibiotic medication in the past month. She is not experiencing dyspnea. Precipitating events Within the past week, PT has not been exposed to someone with strep throat. She has not recently been exposed to someone with influenza. PT has not been in close contact with any high risk individuals. Pertinent COVID-19 (Coronavirus) information Pt is not concerned that her symptoms may be COVID-19. Pt does not work or volunteer as healthcare worker or a first responder. Pt has not had a close contact with a laboratory-confirmed COVID-19 patient within 14 days of symptom onset. PT has been tested for COVID-19.
32 2021-07-27 ringing in ears, eye movement disorder seizures x 3 months, 20-30 a week memory issues ringing in ears brain fog rapid eye movement
32 2021-07-28 mouth numbness, mouth tingling Really bad body and muscle aches; swollen in her glands; bad headache; body aches; potassium was low... Read more
Really bad body and muscle aches; swollen in her glands; bad headache; body aches; potassium was low; Fever; throat felt tight and swollen; throat felt tight and swollen; getting tight, tightness and pain within chest near diaphragm area; getting tight, tightness and pain within chest near diaphragm area; Couldn't breathe four different times; tingling numb feeling on lips and tongue; tingling numb feeling on lips and tongue; tingling down left arm and hand; Felt really tired and out of it; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EW0202), via an unspecified route of administration, administered in Arm Left on 25Jun2021 (received at the age 32-years-old) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included occipital neuralgia and nerve issues from 2018 (The patient would still get occasional flare ups pressure, bad headaches and dizziness from it. The patient clarified this is due to the occipital neuralgia). Family history relevant to the adverse events was none. Concomitant medication were not reported. The patient previously received a shot called ajovy (lot number was unknown, expiry date: May2022) to prevent headaches; she got it two weeks before Covid Vaccine. The patient experienced couldn't breathe four different times on 25Jun2021; tingling down left arm and hand on 25Jun2021; felt really tired and out of it on 25Jun2021; tingling numb feeling on lips and tongue on 25Jun2021; tingling numb feeling on lips and tongue on 25Jun2021; really bad body and muscle aches on an unspecified date, throat felt tight and swollen on 25Jun2021; throat felt tight and swollen on 25Jun2021; getting tight, tightness and pain within chest near diaphragm area on 25Jun2021; getting tight, tightness and pain within chest near diaphragm area on 25Jun2021; swollen in her glands on an unspecified date; fever on 28Jun2021; bad headache on an unspecified date; body aches on an unspecified date; potassium was low on an unspecified date. The patient called about the Pfizer vaccine covid 19. She wants to report a reaction that she had with her first Pfizer vaccine on 25Jun2021 on a Friday. She knows she is sensitive to different medications, with this one it was right off hand. She filled out a paper. When she gave it, she had left arm tingling down left arm and hand. Tingling down left arm and hand; this started immediately right after the shot. This also went away a little after maybe like 10 minutes after. Felt really tired and out of it. They her sit down for a while for 30 to 45 minutes. Then 45 minutes or so later she felt out of it and went to the bathroom. She thought she would go to the bathroom, she went to bend over. Right when she went to bend over she got a tingling numb feeling on lips and tongue. Due to tingling numb feeling on lips and tongue, they gave her an EpiPen. The feeling went to her throat and throat felt tight and swollen. The very worst of it has went away and still lingers on and off. She couldn't breathe four different times. She is still feeling winded. It mostly went away. Between her throat getting tight, and tightness and pain within chest near diaphragm area. She still gets chest pain. She works in factory and still if she does something physical, she has some chest pain. Last night, it was still bothering her. She has to find out what they did in the ER (emergency room) they said her potassium was low and that can affect chest pain and body aches. They gave her potassium pills. She went to the ER (emergency room) within 3 different times within the first week. The main issue was the breathing. The patient was not hospitalized; they usually released her after a couple of hours. She had a fever at the last ER appointment that following Monday. She had really bad body and muscle aches and swollen in her glands. The patient further stated, "one main symptom was issue with breathing, tightness, between throat chest and diaphragm, when or one would act up, I would try to force myself to breath. It's a scary feeling." The patient started with symptoms somewhere right after she got the vaccine, she felt tingling down arm into hand and really tired right after, about 45 minutes later her tongue and lips went tingly and her throat started to feel tight and swollen, then the other symptoms they were all kind of hours to days after the vaccine. She stated, they gave her an epi pen in her leg at the vaccination site in the same building, when she felt like she couldn't breathe. She saw her doctor and was given a two-way answer, at first was told not to get the second dose and then turned around and said if you take the second dose, take it with an anxiety medicine. She added, "I got the pen, and had chest pain not sure what reaction I had." As for the second dose, she is currently set up to receive it on 16Jul2021 (Friday), but she is still debating if she should get it. She saw her doctor this past Friday and she gave her a two-way reaction and said absolutely not then two minutes later she said take anxiety medicine before. She felt like she was overdue for it and they kept saying she should get the vaccine. It became more and more tempting and her friends are not wearing masks. On the paper she filled out it said neurological disorders and she said that she would be fine. Later after the shot, another lady said it might flare up the symptoms. With those kinds of symptoms, she felt a bad headache when she first woke up. Therapeutic measures were taken as a result of tingling numb feeling on lips and tongue and couldn't breathe four different times. No corrective treatment was given for the events tingling down left arm and hand, felt really tired and out of it. All adverse events resulted into a visit to the emergency room and physician office. Outcome of the events tingling numb feeling on lips and tongue was recovering; outcome of the events tingling down left arm and hand and felt really tired and out of it was recovered on 25Jun2021; outcome of getting tight, tightness and pain within chest near diaphragm area was not recovered; outcome of the remaining events was unknown.
32 2021-07-28 lip swelling Allergic reaction broke out in hives on my back then hours later had a swollen lip reaction this has... Read more
Allergic reaction broke out in hives on my back then hours later had a swollen lip reaction this has never happened to me before prior to the vaccination
32 2021-07-28 ringing in ears Ear ringing/sensitivity; Constipation; Ear ringing/sensitivity; Headache across forehead; Joint pain... Read more
Ear ringing/sensitivity; Constipation; Ear ringing/sensitivity; Headache across forehead; Joint pain (especially knees); Fatigue; Muscle soreness; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EW0175) via an unspecified route of administration in the left arm on 30Apr2021 at 11:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to Shrimp. The patient did not take any concomitant medications. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Apr2021 at 22:00, the patient experienced ear ringing/sensitivity, constipation, headache across forehead, joint pain (especially knees). fatigue and muscle soreness. The clinical outcomes of ear ringing/sensitivity, constipation, headache across forehead, joint pain (especially knees), fatigue and muscle soreness were recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
33 2020-12-31 eye pain I received the vaccine in the left arm on 12/23 with no immediate symptoms. On 12/24 I had body ache... Read more
I received the vaccine in the left arm on 12/23 with no immediate symptoms. On 12/24 I had body aches mostly on my left side. On 12/25, I started having a strong headache, focused mostly on the left side. On 12/26 the headache continued and I also noticed swollen lymph nodes on both sides of my neck, and behind my ears. Also, it felt like someone had broken my nose and when I would try to bite down or chew I would have a sharp pain and pressure in my nose and sinuses. On 12/27, the headache continued, and I had severe left eye pain, as well as pain chewing and the swollen nodes, that became painful to touch. On 12/28, I went to my PCP and was tested for covid, which was negative. She diagnosed me with a sinus infection and prescribed amoxicillin. On 12/29, I noticed my scalp had lumps on it that were painful and I had a very itchy spot on my forehead, which became swollen as well to about a quarter size lump. I also had other painful spots on my scalp all over and a continued severe headache and left eye pain. I tried to follow up with my PCP on 12/31, but their office was closed, and the on call nurse referred me to urgent care. More painful, swollen lymph nodes have appeared on my face and neck. I wasn't able to be seen at urgent care until today (1/1), and was then diagnosed with Shingles. I was told to continue amoxicillin and to start taking Valtrex. I am very itchy, mostly on my face, scalp, and left side of my body.
33 2021-01-01 lip swelling Within 2 hours of receiving the vaccine, patient had itchy throat, swollen lip which was confirmed o... Read more
Within 2 hours of receiving the vaccine, patient had itchy throat, swollen lip which was confirmed on exam by ED physician and she received benadryl which resolve the event.
33 2021-01-02 eye swelling Hives red dot rash swollen eyes and face
33 2021-01-02 taste disorder Within the first 12 hours I developed a fever of 102 - 103 degrees farenheit and chills with headach... Read more
Within the first 12 hours I developed a fever of 102 - 103 degrees farenheit and chills with headache and substantial fatigue. The chills went away after the first day. The 2nd day I still had a fever. Day 3 I had significant nausea in conjunction with headache. These symptoms have continued from days 4 - today, day 11 post vaccine. While they are improving, after the initial fever/ chills my symptoms translated to into seemingly hormonal with nausea, strong food aversions, headaches (that felt hormonal) and 4+ days with substantial constipation and fatigue. It has mirrored the sickness I experienced with both pregnancies however I am not pregnant. I am still experiencing a mixture of fatigue, headaches, nausea and food aversions (food still does not taste normal).
33 2021-01-03 taste impairment Approximately 10 minutes after injection patient started to complain of an itchy throat and a metall... Read more
Approximately 10 minutes after injection patient started to complain of an itchy throat and a metallic taste in her mouth. No acute distress noted. No oral, facial or throat swelling noted. Lungs clear bilaterally and patient moving air without difficulty. Skin warm and dry. Patient speaking clearly and in full sentences. Patient continued to be monitored.   Patient complained of slight chest "tightness" and increased mucus production approximately 20 minutes after initial vaccination. Upon exam no acute distress noted. Lungs clear bilaterally. Skin warm and dry. Patient speaking clearly and in full sentences. Patient able to manage oral secretions, no drooling noted. No oral, facial or throat swelling noted. No notable redness or rash observed. EMS called and arrived without incident.   Patient discharged by EMS and was advised by them to go home and take a benadryl. Discussed EMS recommendation with patient and she verbalized understanding and stated that she would call 911 or go to ER if symptoms change or worsen.
33 2021-01-03 taste impairment Approximately 10 minutes after injection patient started to complain of an itchy throat and a metall... Read more
Approximately 10 minutes after injection patient started to complain of an itchy throat and a metallic taste in her mouth. No acute distress noted. No oral, facial or throat swelling noted. Lungs clear bilaterally and patient moving air without difficulty. Skin warm and dry. Patient speaking clearly and in full sentences. Patient continued to be monitored.   Patient complained of slight chest "tightness" and increased mucus production approximately 20 minutes after initial vaccination. Upon exam no acute distress noted. Lungs clear bilaterally. Skin warm and dry. Patient speaking clearly and in full sentences. Patient able to manage oral secretions, no drooling noted. No oral, facial or throat swelling noted. No notable redness or rash observed. EMS called and arrived without incident.   Patient discharged by EMS and was advised by them to go home and take a Benadryl. Discussed EMS recommendation with patient and she verbalized understanding and stated that she would call 911 or go to ER if symptoms change or worsen.
33 2021-01-04 loss of taste, loss of smell loss of taste & smell, nasal congestion, got tested for COVID-19 on 1/04/2021 and it was Positive
33 2021-01-04 taste impairment tachycardia; dizziness; throat swelling; blotches on chest; palpitations; chest tightness/had residu... Read more
tachycardia; dizziness; throat swelling; blotches on chest; palpitations; chest tightness/had residual mild chest discomfort and noticed 2 blotches on chest in car; metallic taste in mouth; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) via Intramuscular on 28Dec2020 12:30 PM at single dose in the arm left for COVID-19 immunisation. Medical history included Bee venom (anaphylaxis), hereditary fructose intolerance (HFI, HFI as above but no previous issues with sucrose containing vaccines) and Known allergies: Bee venom (anaphylaxis). Concomitant medications included Linaclotide, Adderall, polyethylene glycol 3350. Roughly 5-7 minutes after injection, the patient experienced palpitations, chest tightness, and metallic taste in mouth - sensations mostly subsided after another 5 minutes so did not report. Left center after 30 mins, the patient had residual mild chest discomfort and noticed 2 blotches on chest in car. Drove home - on the way at 13: 15 (45 mins post vaccine), developed throat swelling, severe chest tightness, tachycardia (HR 130s), and dizziness. Severe symptoms (throat swelling particularly) subsided after 5 minutes but other symptoms persisted for another hour. Used albuterol, had epi pen ready but didn't use. Now 3 hours out, feeling close to baseline. The patient underwent lab tests, which included Covid test post vaccination with Negative result in Dec2020. The patient received treatment for events, which included Albuterol. Outcome of events was recovering.
33 2021-01-04 taste impairment Patient had a weird taste in her back of her throat. Patient ate crackers and taste went away.
33 2021-01-04 tongue itchiness 25 minutes after injection got light headed, BP was taken by RN 139/91, face then got red, hot and i... Read more
25 minutes after injection got light headed, BP was taken by RN 139/91, face then got red, hot and itchy. II was taken to the Emergency Department for further observation. I I also experience some nausea, my tongue was slightly itchy, I had a stomach ache and some redness/swelling round the injection site. At the ED I was given 25 md Benadryl PO and observed for another hour and a half before being discharged.
33 2021-01-05 loss of taste, loss of smell I developed congestion and nasal burning. Loss sense of smell and taste. Headache and muscle aches. ... Read more
I developed congestion and nasal burning. Loss sense of smell and taste. Headache and muscle aches. I went to medical facility for a COVID19 test on the morning of 12/31/2020. I ended up testing Positive for COVID19.
33 2021-01-05 loss of taste, loss of smell Employee called nurse line, had COVID vaccine left deltoid 12/23 and began having symptoms of tickle... Read more
Employee called nurse line, had COVID vaccine left deltoid 12/23 and began having symptoms of tickle in throat, sinus headache, minor loss of smell and taste, congestion on 12/30/2020. Tested positive for COVID 1/4/2021.
33 2021-01-05 pain in jaw, ear pain SOTROAT, JAW PAIN AND EAR PAIN 3 DAYS POST VACCINATION
33 2021-01-06 swelling of eyelid Eyelid swelling on one side, which was the side of vaccination, 8 hours after the dose, quite visibl... Read more
Eyelid swelling on one side, which was the side of vaccination, 8 hours after the dose, quite visible but only mildly bothersome
33 2021-01-07 swollen lips Rash to face and lips, periorbital edema, all lasting 1 week, has not fully resolved. Taking benadry... Read more
Rash to face and lips, periorbital edema, all lasting 1 week, has not fully resolved. Taking benadryl and hydrocortisone cream
33 2021-01-07 dry mouth Developed rash, itching on arm and on chest, tingly feet and dry cough, dry mouth
33 2021-01-07 mouth numbness, dry throat With in 10 mins of receiving 1st dose, I started to feel hot and light headed, my body became very ... Read more
With in 10 mins of receiving 1st dose, I started to feel hot and light headed, my body became very hot, I started to sweat and then my throat started to dry up and close. I notified the provider on watch that was monitoring me during my 15 mins after injection and as the walked me to the room I became more and more dizzy, my throat continued to swell and close, my mask was removed where my face was covered with a rash and hives . The dr. Gave me 50 mg benedryl, and a shot of epinephrine. After wards 911 was called, my heart rate was eventually brought down with the epinephrine as my symptoms began to be controlled. An inhaler was administered because I was short of breath. 3 hours later I was stabilized. I then was recommended to go to urgent care rather the emergency room since the wait was 13 hours to be monitored at the local hospital MLK. I went to urgent care near my home at Hoag hospital and they monitored me and gave me a steroid injection IM. I was discharged with an epi pen just in case abs to take benedryl every 6 hours . The following morning 1/8/21, at 8 am the swelling of my throat retuned I became light headed abs my tongue became numb. I was taken to fountain valley hospital where an IV was started, 500 mg of iv benedryl, another epinephrine injection was given abs I remained under surveillance for another 6 hours. They stated that a lot of people are coming with reoccurring episodes of anaphylaxis after the phizer injection.
33 2021-01-07 lip swelling, swollen tongue Swelling of tongue, lips and face. Hives. Benadryl administered on site. Rapid Response team call... Read more
Swelling of tongue, lips and face. Hives. Benadryl administered on site. Rapid Response team called. Patient was transported to ED. In ED received IV solumedrol, IV fluids and EPI X 1. Full recovery. Discharged from ED to home on 4 days of prednisone.
33 2021-01-07 swollen tongue, taste impairment Anaphylaxis - started with metallic taste in mouth followed by tongue swelling and chest heaviness
33 2021-01-07 swollen tongue, mouth tingling, feeling of choking Within 5 minutes of administration felt tongue/throat tingling, then felt them starting to swell, ma... Read more
Within 5 minutes of administration felt tongue/throat tingling, then felt them starting to swell, making it difficult to swallow, flushing feeling, felt like I was getting tunnel vision (how you feel before you pass out). Reported symptoms to RN who administered shot. Given PO liquid benadryl and epi pen injection quickly- symptoms started to fade within 10-15 minutes, tongue tingly for a few hours. Monitored x 1 1/2 hours with frequent VS checks- HR/BP/SaO2 remained within normal limits
33 2021-01-07 tongue disorder, mouth tingling 10 min post vaccine began c/o tingling in lips and tongue. stated felt like her throat was like a... Read more
10 min post vaccine began c/o tingling in lips and tongue. stated felt like her throat was like a balloon being blown up. mild anxiety, no sob or diff breathing. no diff swallowing. brought from lobby to exam room. VS taken. 25mg of po benedryl given and 0.3mg epi given SQ at approx 09:20 sat with patient and monitored VS frequently approx q 10m for 60m. oxygen sats remained 98-99% on RA, resp were 20 ( initially with anxiousness down to 14 by discharge. P ave 80s BP ave 130/70s symptoms began to resolve by 30min and were resolved at 60min and pt was release d home pt called when she returned home ( 1hr drive ) and was feeling well with mild tongue thickness sensation . advised to repeat 25mg of benedryl po at 3pm and 9pm today advised to call Emergency Services for any return of sob diff breathing swallowing or sense of airway closing
33 2021-01-08 eye swelling Headache, extreme lethargy, full body hives, eyes swollen . Symptoms lasted for about 48 hours.
33 2021-01-10 mouth ulceration, mouth pain fatigue, muscle aches, painful vaginal and oral ulceration, onset of Behcets syndrome following 7 ye... Read more
fatigue, muscle aches, painful vaginal and oral ulceration, onset of Behcets syndrome following 7 years without incidence
33 2021-01-10 mouth tingling Patient noted upper lip tingling at 12 minutes after dose. She subsequently noticed tingling down he... Read more
Patient noted upper lip tingling at 12 minutes after dose. She subsequently noticed tingling down her left arm. Her BP was recorded at 139/81, Po2 97%, pulse: 80, T: 98.8 Also right hand felt cold for 2 minutes. Prior to exit, tingling resolved. Discharged at 2:32p
33 2021-01-11 eye irritation Burning eyes, attempted to ice eyes no relief, no current access to eyedrops. currently ongoing for ... Read more
Burning eyes, attempted to ice eyes no relief, no current access to eyedrops. currently ongoing for 90 minutes with no relief
33 2021-01-11 lip itchiness, mouth tingling she was a lactating; she was a lactating; Have some side effects last night from Covid Vaccine, got ... Read more
she was a lactating; she was a lactating; Have some side effects last night from Covid Vaccine, got hives right above my breast; she has really bad Asthma/because of that she has "shortness of breath"; Felt like itchy like tingling on my lip; Felt like itchy like tingling on my lip; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2 (lot#: EK5730, expiration date: 31Mar2021), via an unspecified route of administration at arm left, on 02Jan2021 04:00, at single dose, for COVID-19 immunization, and salbutamol (ALBUTEROL) via an unspecified route of administration, from an unspecified date, at unknown dose, for asthma. Medical history included ongoing asthma, and ongoing very unslept person, and she was a lactating for she has a baby about year like 13 months ago (2019) so she is still producing milk. Concomitant medication not provided. The patient thought she has some side effects last night from her Covid Vaccine, so she got it yesterday around 4 O'clock and around 10, 10:30 she got hives on her chest, right above her breast, and about an hour after she got the vaccine, she thought it was just her asthma, so she has really bad Asthma, her Asthma kept like, she kept Asthma and because of that she has "shortness of breath" (not clarified), so she was just taking her Inhaler (unspecified medication) but then like last night wherever after that her "bedtime" (not clarified) she got hives on her chest and it felt like itchy like tingling on her lip, she was very unslept person so she just took some Benadryl (treatment) today she woke up fine, she feel fine but she was just thinking it would be okay to take her second dosage (Covid vaccine). When probed if visited to any physician office/ emergency Room for the treatment, consumer stated she just at home, she just took Benadryl. The action taken in response to the events for salbutamol was unknown. The outcome of the events was recovered.
33 2021-01-11 swelling around the eyes Pt. states that she woke up at 2 am on 1/12/21 with bilateral hand rash/hives and periorbital swelli... Read more
Pt. states that she woke up at 2 am on 1/12/21 with bilateral hand rash/hives and periorbital swelling bilaterally. Pt. states that she used eye drops for eye and advil.
33 2021-01-11 ringing in ears Chills, aching body, sweating, nausea, upset stomach/vomiting, dizziness, loud static ringing in ear... Read more
Chills, aching body, sweating, nausea, upset stomach/vomiting, dizziness, loud static ringing in ears while dizzy/vomiting, injection site soreness. Vomiting subsided but other side effects remain in the afternoon the day after vaccination.
33 2021-01-12 dry mouth PT sts after first dose she did not experience any Sx. Second dose in series 28 days later, PT wait... Read more
PT sts after first dose she did not experience any Sx. Second dose in series 28 days later, PT waited in observation area. While seated, she began to feel lightheaded and "hot." BP 114/70, HR 74, RR 16. Drank water on provider orders,. Neg LOC or confusion observed. STS cool air helps. By PT request, she attempted to stand which brought back symptoms. PT observed to have blanched appearance and was placed on stretcher with feet raised on 2 LPM O2, second vitals set 1115/74, HR 72, RR 18. When attempting to sit up after 15 minutes dizziness returned and nausea began. 3rd vitals set 119/79, HR 63, RR 18, O2 increased to 3 LPM by provider, PT occasionally sat up to drink water as her mouth felt dry and dizziness was persistent. 30 minutes after symptoms began, medical staff noted new onset of confusion. PT sts Sx began to resolve 55 minutes after onset. PT removed from O2 and was able to walk without aid to awaiting vehicle.
33 2021-01-12 taste impairment Within minutes of receiving the vaccine Pt said she developed a "fruity" taste in her mouth. She sai... Read more
Within minutes of receiving the vaccine Pt said she developed a "fruity" taste in her mouth. She said she got dizzy, extremely hot and felt like she was "swaying" She said she also got what she described as "menstrual like cramps" that radiated all around her abdomen and back. She was under observation as advised per Pfizer protocol. An associate of the Pt noticed she passed out for a second she then turned beet red from her head to her neck as we could see. The associate yelled for us to grab a BENADRYL. They hooked her up to a BP machine and she did present with a spike in BP. After a few minutes, the redness and symptoms subsided. She was observed by the medical staff at the facility.
33 2021-01-12 lip swelling 01/11/2021 at 5pm started with diarrhea, chills, body aches. 01/12/2021 06:00pm facial swelling, l... Read more
01/11/2021 at 5pm started with diarrhea, chills, body aches. 01/12/2021 06:00pm facial swelling, lip swelling, hives. Started Benadryl at home on 01/12/2020. Seen by walk in PMD office 01/13/2021. MD prescribe, 60mg prednisone and to continue Benadryl, 50mg as needed.
33 2021-01-12 swollen tongue Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing st... Read more
Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing star" as well feeling sob, throat tightness, sweaty hands. Has no PMHx. Not taking any medications Allergies: None. Denies any food allergies. Has gotten Flu shot yearly w/o any side effects. No prior allergic reaction to vaccines. Temp 98.4, BP 140/92 mm Hg, 142/87 mm Hg, HR 120 /min, 158 /min, RR 24 /min, Oxygen sat % 99 %. Exam: in acute distress, + erythema macular rash noted on forehead/periorbital region. Notice sweaty palms/hand tremors. Throat: a bit swollen tongue. Heart: sinus tachy. Lungs: no stridor, no intercostal retraction seen, clear to auscultation bilaterally, no wheezes, rales. Given Benadryl 50mg QD and Epi-pen (left thigh) and given 2 puff of Proventil inhaler. Pt drank 1-2 cups of water. Called 911. After Epi-pen, her HR trended down from 158 - > 120 - > 99 (in 1-2 min). Pt felt better, rash on her forehead/occipital region subsides after 10-15 min. Her shakiness of hand minimal. Her SpO2: 99 % (remains the same) Still feel a bit tightness of her throat (discomfort when swallowing). Her breathing is stable and talking w/o any discomfort by the time the ambulance came over. Her repeated BP: 142/87, HR: 99. I advised to take her to ER for close monitoring (risk of possible developing another reaction).(NEXT PAGE)
33 2021-01-12 ringing in ears Pfizer-biontech covid-19 vaccine eua Dizzy, light headed, hot, ears ringing, mild headache, tiredne... Read more
Pfizer-biontech covid-19 vaccine eua Dizzy, light headed, hot, ears ringing, mild headache, tiredness, fatigue,
33 2021-01-13 loss of smell, loss of taste Approx 9 hours after receiving second dose of Pfizer COVID-19 vaccine, I began having uncontrollable... Read more
Approx 9 hours after receiving second dose of Pfizer COVID-19 vaccine, I began having uncontrollable chills, could not get warm, spiked a fever of 100.4, severe body aches, barely could not move. It was all I could do to finish my shift at work, drive home, get in the shower, and pass out in bed to sleep. I slept a good solid 10 hours, woke up for work...fever was then gone and chills, but I had a severe headache, still had severe body aches/fatigue, but I also lost my sense of taste and smell. I ate a waffle which tasted like cardboard, drank cranberry juice (my mouth puckered like it was tart, but I could not taste it at all). I reported to work but was immediately sent home by my employee health nurse to be seen by a health care provider and to be tested for COVID-19. I went home and slept an additional 5 hours, did not do anything at home but rest, and slept a solid 12 hours straight that night. Still could not smell and taste. The following day, I could smell things like Vicks vapor rub and I could taste things minimally like when I initially bit into them, or on the back end if that makes sense. Still had body aches and fatigue, but nothing like that previous day or the night before that. I was then told that evening my PCR test was negative, and I could report to work the following day. 1/14/2021, I felt almost completely back to normal, and I could smell and taste.
33 2021-01-13 eye strain, eye irritation body is cold; Occasionally some nauseous sensation but didn't throw up; Eyes feel so tired; hard to ... Read more
body is cold; Occasionally some nauseous sensation but didn't throw up; Eyes feel so tired; hard to concentrate; it bother my sleep; first dose on 19Dec2020, second dose on 06Jan2021; heaviness in the head when I woke up next day; some hot/spicy sensation around eyes area; didn't even have good appetite during lunch time on day 2; sever headache started at night of day one; This is a spontaneous report from a contactable Other HCP (patient). A 33-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EK9231), on 06Jan2021 14:30 via an unspecified route of administration in the left arm at single dose COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) on 19Dec2020 09:45 in the left arm at single dose for COVID-19 immunisation. On 06Jan2021 at 23:00, started at night of day one, the patient experienced severe headache. The patient experienced also heaviness in the head when she woke up next day (07Jan2021) and had some hot/spicy sensation around eyes area (07Jan2021). The patient needed to take paracetamol (TYLENOL) to get some relieve and she did not even have good appetite during lunch time on day 2 (07Jan2021). On unspecified date the patient had no fever and her body was cold; occasionally some nauseous sensation but didn't throw up. Eyes feel so tired and hard to concentrate. Hopefully those symptoms go away soon as days pass since it bothered patient sleep. The patient had a doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. The patient took also guaifenesin (MUCINEX). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
33 2021-01-13 eye swelling, swelling of eyelid about 10 hours after administration, I developed SOB, mild chest pain, hoarseness, and right sided w... Read more
about 10 hours after administration, I developed SOB, mild chest pain, hoarseness, and right sided wheezes. I self treated with albuterol (2 puffs) inhaler that I have on hand in case of environmental allergy triggers (I rarely have to use it- last use 3 years ago). The wheezing resolved and chest pain improved but the hoarseness remained. Over the next 2-3 hours I developed headache, malaise, mild dizziness, arthralgia, myalgia, and eventually fevers and chills (by 13 hours after vaccine administration). When fever reached 101 I self treated with naproxen 250mg. I slept for 4 hours and awoke diaphoretic, but the fever had resolved and I felt much better. However, I developed urticaria that started on my flexor surfaces of the elbows, hips, and knees, and spread to my adbomen, thighs, and face, with swelling about my right eye. I self treated with 25mg benadryl and itching and urticaria improved to the point that I was able to sleep. When I awoke the next morning my symptoms had largely resolved with the exception of mild headache, body aches, hoarseness, slight chest tightness, and mild residual swelling of the right eyelid.
33 2021-01-13 eye swelling Right eye and cheek is swollen; Right eye and cheek is swollen; right sided headache; right sided ne... Read more
Right eye and cheek is swollen; Right eye and cheek is swollen; right sided headache; right sided neck muscle spasm and tightness.; right sided neck muscle spasm and tightness.; This is a spontaneous report from a contactable Other HCP. This Other HCP (patient) reported that the 33-year-old female patient who received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on Arm right on 30Dec2020 at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Asthma and Behcets syndrome. No Known allergies to medications, food, or other products. Concomitant medications included the patient received within 2 weeks of vaccination: Albuterol inhaler (Inhalation vapour, solution), Magnesium, ergocalciferol (VIT D), Ashwagandha. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced right eye and cheek is swollen, right sided headache and right sided neck, muscle spasm and tightness from 07Jan2021 07:00AM. No COVID prior vaccination. No COVID tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment was received for the adverse event included OTC ADVIL, PPI, Sudafed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered. Information on the lot/batch number has been requested.
33 2021-01-13 ringing in ears Tinnitus RT ear and light headache
33 2021-01-13 ringing in ears symptoms started on 01/13/21 : tinnitus in rt ear and light headache
33 2021-01-13 vision blurred tactile overstimulation?(having clothing or a blanket hurt and irritated my skin); Extreme headache;... Read more
tactile overstimulation?(having clothing or a blanket hurt and irritated my skin); Extreme headache; blurred vision at long distances; lightheadedness; occasional off balance; diarrhea; low grade fever; body aches; This is a spontaneous report from a contactable Nurse. This 33-year-old female Nurse (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), intramuscular on 05Jan2021 06:45 AM at single dose on left arm for COVID-19 immunisation. Medical history included hypertension (HTN), depression and anxiety. No known allergies. Concomitant medication included quetiapine fumarate (SEROQUEL), metoprolol, hydrochlorothiazide, lithium, alprazolam (XANAX), lamotrigine (LAMICTAL), folic acid / iron (PRENATAL), multivitamins [vitamins nos] (MULTIVITAMINS), melatonin, ibuprofen, paracetamol (TYLENOL). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: Eh9899), intramuscular on 15Dec2020 07:30 AM on left arm for COVID-19 immunisation. The patient extreme headache with blurred vision at long distances (blurred vision resolved after 24 hours) lightheaded ness/occasional off balance, diarrhea, low grade fever, body aches, tactile overstimulation (having clothing or a blanket hurt and irritated her skin) on 06Jan2021 01:00 AM. No treatment was received for the events. The outcome of the event blurred vision at long distances was recovered in Jan2021. The outcome of other event was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
33 2021-01-14 loss of taste, loss of smell On Sun 12/27 around 12pm I had left arm tenderness and I was fatigued and then at 5pm I had a fever ... Read more
On Sun 12/27 around 12pm I had left arm tenderness and I was fatigued and then at 5pm I had a fever starting at 99.5 and by 11pm 103.5 I had body aches chills, rigers, fever did not break with tylenol or advil . I had the fever until Monday afternoon and it broke for a few hours and came back and did not budge from 101. I called occupational health and asked questions about my fever, monday night at 8pm I had a bad dry cough and SOB and chest tightness and sinus congestion, no sneezing or runny nose, still with a fever. I called occupational health again and they said to come in to get covid tested and results were positive Tuesday 29th AM. On Thursday I started taking medicine: 5 day course of singulair, slow vent albuterol prn teflex antibiotic and calcium, Zinc and Vitamin D. The fever started to break around Monday the1st to the 4th around 99 to 100 . The 4th I lost sense of taste and smell and Monday the 28, 2020 I had neuromuscular pain in stiffness in legs and I had trouble walking and when fever got lower I realized I was having pain in my feet and hips. I think the infection triggered the unknown neuromuscular condition. I was supposed to go to work the 11th but since I was still having leg issues and my leave was extended one more week. I do not believe these reactions were due to the vaccine I think it was just a coincidence I contracted COVID prior to getting the vaccine
33 2021-01-14 taste impairment, swollen tongue had a metallic taste; turned to swollen tongue; hives around chest and neck; difficult to breathe; t... Read more
had a metallic taste; turned to swollen tongue; hives around chest and neck; difficult to breathe; tachycardia; This is a spontaneous report from a contactable other HCP (Patient). A 33-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL 3248), via an unspecified route of administration at right arm on 07Jan2021 16:15 at single dose for covid-19 immunization. Vaccine was administered at hospital. Known allergies included cyclobenzaprine and dairy latex. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 10 mg, gabapentin 300 mg, venlafaxine 150 mg. No other vaccine in four weeks. Three minutes after vaccination the patient had a metallic taste, turned to swollen tongue, hives around chest and neck, difficult to breathe, and tachycardia on 07Jan2021 16:18. The events resulted in Emergency room/department or urgent care. Treatment received included Epinephrine, methylprednisolone sodium succinate (SOLU-ME dork) and famotidine (PEPCID) also diphenhydramine HCl (BENADRYL). The outcome of the events was unknown.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for events metallic taste, swollen tongue, hives, difficulty breathing and tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-01-14 mouth numbness Numbness on the face; Numbness along the left side of her mouth; This is a spontaneous report from a... Read more
Numbness on the face; Numbness along the left side of her mouth; This is a spontaneous report from a contactable consumer (patient). This 33-year-old female consumer received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142 and Expiration date was Mar2021) on 08Jan2021 12:30 (at the age of 33-years) as single dose, unspecified route in left arm for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 08Jan2021 16:10 she started to experience numbness on the face and numbness along left side of mouth. The outcome of event numbness on the face was unknown, and numbness along left side of mouth was unknown.
33 2021-01-14 lip swelling I had experienced body aches, and chills on the day of the vaccine. On Monday following the vaccine ... Read more
I had experienced body aches, and chills on the day of the vaccine. On Monday following the vaccine I had hives all Over my body which were treated with Benadryl. On Tuesday the hives persisted but treated during the day with Benadryl, at about 10:30pm the hives started to show on my face, my lips got swollen, and I felt like a pit in my throat That was stuck. I went to the ED and I was treated with IV Benadryl, IV Pepcid, and IV Solumedrol. I left the ED upon signs of improvement and was given prescriptions for Epi pen and steroids for 4 days.
33 2021-01-14 lip swelling Vaccinated 1/11/2021 at 11:30 AM, at approx. 10 PM experienced moderate pain scale diffuse body ache... Read more
Vaccinated 1/11/2021 at 11:30 AM, at approx. 10 PM experienced moderate pain scale diffuse body aches. This lasted a few hours, improved with advil. After body aches subsided at around 2 AM 1/12/2021 experienced mild allergic reaction of hives and lip swelling. This allergic reaction subsided by morning 1/12 with benadryl. I have never had any side effects or allergic reaction to a vaccine. I did experience similar mild allergic reaction with antibiotic bactrim, a sulfa based medication.
33 2021-01-14 eye discomfort Within one hour of shot: Mild facial tingles especially surrounding L eye, mild fatigue Within a fe... Read more
Within one hour of shot: Mild facial tingles especially surrounding L eye, mild fatigue Within a few hours: increased fatigue, mild ?brain fog? with some word finding difficulty, mild pressure behind eyes 3am, ~16 hours post: mild to moderate body aches, low grade fever 98-99 degrees 8am, ~21 hours post: mild body aches, back to normal temp, continued fatigue, TERRIBLE headache! 7-8/10 pain for about 10 hours. Throbbing in temples, eye pressure, pressure on top of head, worsened when I would bend over. Did not take any medication, worried it would impact immune response. Drank a lot of water, slept, did some sled massage, and gentle yoga/stretches. By that evening pain level had dropped down to about a 4. Woke up the next morning with 2-3 level pain, was able to go to work without being distracted by pain. Still felt more pressure behind eyes and top of head when I bent over. Next day all symptoms resolved, except very minor tenderness at injection site only when palpated.
33 2021-01-15 dry throat dry itchy throat starting within 20 minutes. waited until approx 330 to take a benadryl as it was ha... Read more
dry itchy throat starting within 20 minutes. waited until approx 330 to take a benadryl as it was harder to swallow, an hour and a half later hives began to show at approx 530 went to urgent care. was prescribed steroids. took benadryl over night to keep from iching and started steroids this morning. no more hives have showed since going to urgent care.
33 2021-01-16 mouth tingling Patient reported trouble breathing, tachycardia, tingling in face and lips, flushing on the day of v... Read more
Patient reported trouble breathing, tachycardia, tingling in face and lips, flushing on the day of vaccination. That day she took 25 mg of Benadryl, then another 25 mg of Benadryl 5 minutes later. Her symptoms got slightly better, but she had to take another 25 mg in the evening. She reports having a headache, muscle aches and pains for 3 days after vaccination.
33 2021-01-16 tongue discomfort, mouth tingling, feeling of choking Tingling and burning sensation on tongue, back of throat and left side of face when awoke after a li... Read more
Tingling and burning sensation on tongue, back of throat and left side of face when awoke after a little over 48 hours post vaccination. I took Benadryl which took the edge a little off of the sensation. The discomfort lasted throughout the day.
33 2021-01-17 loss of taste, loss of smell Arm soreness at vaccine site that night; moderate pain. Was exposed to COVID 20 hours after 1st vacc... Read more
Arm soreness at vaccine site that night; moderate pain. Was exposed to COVID 20 hours after 1st vaccine. Developed symptoms of COVID that Monday - five days after vaccine. Tested COVID positive that same day. Started with headache, then I had a fever over 101. Chills - bad chills. Lost my taste and smell a couple days after that and that lasted a long time (about three days to get smell back and 10 days for taste). Just took Tylenol for the fever and headache. Also got leg pain - muscle type aches - painful - started on the 29th of December. Leg pain lingered and the pain went away by about the 7th of January. Took Tylenol as needed for that pain.
33 2021-01-17 mouth tingling, feeling of choking Pt is 33 yo female with h/o multiple drug allergies , including allergy to benadryl. She has receive... Read more
Pt is 33 yo female with h/o multiple drug allergies , including allergy to benadryl. She has received first dose of COVID vaccine made by Phfizer at 3:45. She reports about 10 minutes after the vaccination she started feeling tingling in her lips, throat and prickly sensation on her chest and feeling "off". Felt dizzy, developed small hives on her chest. She was attended to immediately at the vaccine site and our team was called to white code. Pt was sitting on the floor, alert , breathing comfortably. Her BP was 151/84, HR 90, O2 Sats 100%. Her lungs were clear the whole time, no wheezing, no difficulty swallowing or talking. Patient received 125 mg of IV solumedrol and 20 mg of pepcid in vaccination room, she felt the same, still breathing comfotably, speaking full sentences, hives faiding away. She was transported to Urgent Care clinic on wheelchair. Pt kept her EpiPen by her site the whole time but refused to used it, states she is afraid to use it and wants to hold off or get it in ER if necessary. About 16:30 patient reported her tingling, prickly sensation In her chest is getting worse, developed sensation of lump in her throat, able to swallow and breath without problems, lungs exam clear. Again recommended to give Epipen but patient again refused as she feels very anxious about getting new medicine. She was able to speak full sentences and breathing well, O2 Sats 100% the whole time, she repetitively refused EpiPen. EMS called and patient transported to ER, ER notified. Pt left in stable condition.
33 2021-01-17 feeling of choking, ear swelling Ear swelling, hives on face and neck, facial tingling, rash on cheeks, tingling and itchiness in thr... Read more
Ear swelling, hives on face and neck, facial tingling, rash on cheeks, tingling and itchiness in throat and face - 45-60 minutes after injection. Waiting for 30 minutes and no adverse effects until leaving facility
33 2021-01-17 feeling of choking Tingling in throat, and dizziness.
33 2021-01-17 sensitivity to light 1/6/21 dizzy, nausea, photophobia- 45 minutes after vaccine
33 2021-01-18 tongue disorder, taste impairment Metallic taste and metallic cold feeling on tongue, intermittent. It was all the time the first two ... Read more
Metallic taste and metallic cold feeling on tongue, intermittent. It was all the time the first two days, then it started to come and go, and has subsided over time to only be once or twice a day for roughly 15 minutes at a time.
33 2021-01-19 pupils dilated left pupil dilated
33 2021-01-20 eye swelling, eye itchiness itchy left eye beginning one hour after vaccination chills the day after vaccination mild cough the ... Read more
itchy left eye beginning one hour after vaccination chills the day after vaccination mild cough the day after vaccination extreme fatigue for 36 hours swollen puffy left eye the day after vaccination, still currently experiencing more that 40hrs after vaccination
33 2021-01-20 pain in jaw Jaw ache/pain - unable to sleep due to it; Jaw ache/pain - unable to sleep due to it; This is a spon... Read more
Jaw ache/pain - unable to sleep due to it; Jaw ache/pain - unable to sleep due to it; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ES1686) in a hospital, via an unspecified route of administration at the left arm on 08Jan2021 at 11:00 AM at single dose for COVID-19 immunization. The patient's medical history included birth control. No other medical history and has no known drug allergies. The patient had no COVID prior to vaccination. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL) birth control pills. The patient experienced jaw ache/pain - unable to sleep due to it on 10Jan2021 at 18:00 (06:00 PM) and these were not relived by Advil. The patient has not been tested for COVID post-vaccination. The clinical outcome of the events was not recovered.
33 2021-01-20 swollen tongue broke out in rash/hives all over; broke out in rash/hives all over; mild tongue swelling; sob throat... Read more
broke out in rash/hives all over; broke out in rash/hives all over; mild tongue swelling; sob throat felt sore and swollen; sob throat felt sore and swollen; swelling at injection site; redness at injection site; itching at injection site; feverish; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number=Ej1685, via an unspecified route of administration on left arm from 07Jan2021 11:00 to 07Jan2021 11:00 at SINGLE DOSE (dose 2) for COVID-19 immunisation. The patient as no known allergies, no other medical history, and no allergies to medications, food, or other products. Historical vaccine includes first dose of BNT162B2 on 18Dec2020, time=12:45 PM, vaccine location=Left arm, lot number=Eh9899. The patient's concomitant medications were not reported. On 08Jan2021 05:00 AM, the patient experienced post vaccine swelling, redness, itching at injection site and feverish. On 13Jan2021, the patient broke out in rash/hives all over with mild tongue swelling and sob throat felt sore and swollen for a short time. The patient went to physician and received steroid injection and Benadryl. The outcome of the events was recovering.
33 2021-01-20 vision blurred, eye discomfort 1/30/21: 20 minutes after injection, complaints of lightheadedness and numbness left side of face o... Read more
1/30/21: 20 minutes after injection, complaints of lightheadedness and numbness left side of face orbital region; Patient states she returned to clinic area and the staff gave no advice to manage symptom & ?just continue to carry epilepsy?; 1/21/21: Patient stayed she received a telephone call from the pharmacist who administered shot who instructed her to file a report with CDC; 1/21/21 5:25pm Patient reported that her sight in right eye has become blurry and feels pressure in eye I recommended to go to ED and contact physician
33 2021-01-21 mouth numbness, mouth tingling Numbness and tingling sensation with tongue, lips, and around lip area.
33 2021-01-21 swelling around the eyes Hives on face, back of neck, top of back, orbital swelling left and right eye
33 2021-01-21 feeling of choking, mouth numbness, mouth tingling Tongue was numb for 3 hours. Then base of tongue and throat were tingling and cold.
33 2021-01-22 pain in jaw fever of 103.3, chills, nausea, shaking, headache, jaw ache, joint pain, cramping lasting 8-10 hours... Read more
fever of 103.3, chills, nausea, shaking, headache, jaw ache, joint pain, cramping lasting 8-10 hours. took tylenol and advil
33 2021-01-24 mouth numbness Increase blood pressure, tongue numbness, pressure in head
33 2021-01-24 taste disorder passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode... Read more
passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode of hypertension; feeling hot; was "swaying"; had menstrual like cramps that radiated from her abdomen to her entire body; had menstrual like cramps that radiated from her abdomen to her entire body; This is a spontaneous report from a contactable pharmacist. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at the first single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. Within in minutes of receiving the vaccine on 13Jan2021, the patient reported a fruity taste in her mouth, turned "Beet red" on her neck/face, and passed out briefly. When she regained consciousness, she was given Benadryl, and also was reported to have an episode of hypertension. She reported feeling hot and was "swaying" and had menstrual like cramps that radiated from her abdomen to her entire body. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the event "passed out briefly". The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021027150 same reporter/drug, similar event, different patient
33 2021-01-25 lip swelling, swelling of eyelid started at my chin and my jaw line and to my cheek bones and had hives, face started to swell, lips,... Read more
started at my chin and my jaw line and to my cheek bones and had hives, face started to swell, lips, and eyelids, had to take 2 Benadryl.
33 2021-01-25 pain in jaw Headache / Jaw pain / tingling of mouth and tongue then chin, face, neck and arms / nausea
33 2021-01-27 mouth tingling tongue tingling Narrative: "Fullness back of neck" 5 min after vaccination 2nd. Hx uncontrolled hype... Read more
tongue tingling Narrative: "Fullness back of neck" 5 min after vaccination 2nd. Hx uncontrolled hypertension on no meds. Observed 30 min. 12:24 182/132, hr 92. 12:27 185/113 mild tongue tingling. 12:50 176/117 tingling resolved. PCP for f/u chronic htn. Asymptomatic HTN.
33 2021-01-27 feeling of choking, mouth tingling tingling in my throat; tingling on the tongue and bottom lip; Burning sensation in my throat, on the... Read more
tingling in my throat; tingling on the tongue and bottom lip; Burning sensation in my throat, on the tongue and bottom lip and on the left side of the face as well; tingling sensation developed on the left side of the face; This is a spontaneous report from a non-contactable pharmacist reporting for herself. A 33-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El1283), via an unspecified route of administration on 14Jan2021 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 33 years. The vaccine was administered in the Clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included migraine very infrequent. Concomitant medications included norethisterone (NORETHINDRONE). The patient had no known allergies. She reported that slightly over 48 hours post injection on 17Jan2021 she developed a tingling and burning sensation in throat, on the tongue and bottom lip. A burning or tingling sensation developed on the left side of the face as well. Treatment for the events included Benadryl. The patient had not recovered from the events at the time of the report. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
33 2021-01-27 sudden hearing loss Sudden hearing loss began the evening following the vaccination
33 2021-01-28 taste impairment 1ST TIME - INJ 1/6/21 EL0142 (throbbing headache after I left the hospital. It didn't go away until ... Read more
1ST TIME - INJ 1/6/21 EL0142 (throbbing headache after I left the hospital. It didn't go away until I took 2 Exedrin & went to bed. I also had some nausea as well and was fatigued). 2ND VACCINE - INJ 1/29/21 EL324 (much worse - fatigue, muscle pain, extreme nausea, headache, and metallic taste in mouth after 15 min wait passed. i also had an inj site reaction. my right arm was burning and i had a stinging pain)
33 2021-01-28 eye pain Elevated fever Full body muscle aches Headache Ophthalmalgia
33 2021-01-28 eye swelling facial and eye swelling. No anaphylaxis noted.
33 2021-01-28 mouth tingling, mouth numbness 2nd reaction- numb and tingling on right upper arm fingers, toes, foot, tongue and upper lip. Moved... Read more
2nd reaction- numb and tingling on right upper arm fingers, toes, foot, tongue and upper lip. Moved to left side hand and foot with numbness, tingling. Today this still continues with hands and feet of numbness and feet
33 2021-01-28 mouth tingling The patient received her second dose of Covid-19 vaccine today at 10:18am. At around 10:43 am, the ... Read more
The patient received her second dose of Covid-19 vaccine today at 10:18am. At around 10:43 am, the patient started to feel tingling of her tongue.
33 2021-01-28 vision blurred Within 5 minutes of dose, blurry vision and dizziness started followed by fast heart rate. pharmaci... Read more
Within 5 minutes of dose, blurry vision and dizziness started followed by fast heart rate. pharmacist gave 1 dose of IM EPI in the L thigh
33 2021-02-02 dry mouth - [ ] Day 1: severe migraine (2-2.5 hours after the shot) - [ ] Day 2: muscle aches, nausea, fatigue... Read more
- [ ] Day 1: severe migraine (2-2.5 hours after the shot) - [ ] Day 2: muscle aches, nausea, fatigue - [ ] Day 3: muscle aches, migraine, serious heartburn, nausea, dizziness, cold sweats, fatigue, loss of breath, abdominal/chest pain (questioned if it was a heart attack) - [ ] Day 4: nausea, cold sweats, fatigue, abdominal pain, mild muscle aches, dry mouth - [ ] Day 5: woke up at 1100. Already very fatigued and cold sweats. Dizzy. Napped from 1415-1545. Dry mouth. - [ ] Day 6: fatigue, nausea, dry mouth, injection arm numb/tingly. - [ ] Day 7: fatigue, nausea, dry mouth, mild migraine, lower abdominal pain - [ ] Day 8: nausea, abdominal pain
33 2021-02-02 eye pain 1/27 afternoon -Foggy, forgot what she was doing . 1/27 evening -full body shaking. Felt she could n... Read more
1/27 afternoon -Foggy, forgot what she was doing . 1/27 evening -full body shaking. Felt she could not grasp with right hand. Right eye pain, throbbing.1/29 Loose stool. 1/30 Loose stool , nausea,shaking, lethargy. 1/31 - felt better. Right hand grasp still felt off.
33 2021-02-02 vision blurred Severe Dizziness, Nausea, Chills, Confusion, Stomach Pains, Body Aches, Bad Headaches, Blurred Visio... Read more
Severe Dizziness, Nausea, Chills, Confusion, Stomach Pains, Body Aches, Bad Headaches, Blurred Vision, and Shortness of Breath
33 2021-02-03 swollen tongue Difficulty breathing, reported tongue swelling, heart racing, felt abnormal
33 2021-02-03 taste disorder After work, she started to feel swelling on the right side of her throat with a lot of pain in her t... Read more
After work, she started to feel swelling on the right side of her throat with a lot of pain in her throat. This pain lasted for about a week. She states that her lymph nodes were significantly and noticeably enlarged. She tried to contact her physician at the hospital but was unable to get in contact with a physician. Headaches from Friday night (1/15/2021) to Tuesday (1/19/2021). Medicine taste in mouth during work then started to get headaches and then throat started to swell. Right now, she doesn't have any headaches, but the lymph nodes on the right side is still slightly swollen and painful to the touch. Not as pronounced as the first few days.
33 2021-02-04 taste disorder Report fever (101.1) HA, body aches, left arm pain 10 hours post vaccination and funny taste in mo... Read more
Report fever (101.1) HA, body aches, left arm pain 10 hours post vaccination and funny taste in mouth 10 minutes after vaccination. Funny taste resolved. Treatment: Tylenol with mild improvement. Outcome does not interfere with ADLs.
33 2021-02-06 toothache, chewing disorder, pain in jaw It started out as general body aches. Then twelve hours post vaccine I got a fever of 103.4. My feve... Read more
It started out as general body aches. Then twelve hours post vaccine I got a fever of 103.4. My fever was consistent for almost 36 hours. After it broke I would be fine and then have hot flashes and then become cold. I had a horrible pain between my shoulder blades that radiated into my left chest. I had a headache that lasted for 4 days. No matter the pain reliever used nothing touched the pain. My head hurt so bad it made me nauseous and dizzy. I had excruciating left sided jaw pain. It hurt to open my mouth. It shot up through my jaw into my teeth. I was unable to chew anything on that side due to pain, but I ate very little.
33 2021-02-07 photosensitivity reaction Approximately 3 hours after receiving the vaccine, patient developed slight soreness at injection si... Read more
Approximately 3 hours after receiving the vaccine, patient developed slight soreness at injection site (noticeably less than following dose 1 of this vaccine). Then, at approximately 12 hours post-dose, developed the following symptoms lasting the entirety of the night: generalized/dull headache, photosensitivity, generalized myalgias/arthralgias, subjective fever/chills alternating with cold sensitivity. All symptoms except headache resolved by the next morning, but at approximately 24 hours post-dose, all symptoms returned and lasted for the remainder of that day. By the next day, all symptoms had completely resolved and have since not recurred.
33 2021-02-08 taste impairment Patient was received her Covid vaccination in her right arm approximately 9:15am. With about 5 minu... Read more
Patient was received her Covid vaccination in her right arm approximately 9:15am. With about 5 minutes she became shaky, sweaty, flushed, and stated she had a ?medication taste in mouth?. She had eaten breakfast, but was given a snack & juice. Nurse reported slightly elevated BP (exact numbers not given). Patient was taken to ER for care.
33 2021-02-08 mouth numbness Patient reported mild headache after ~10 minutes after vaccine administration, and lip numbness ~15 ... Read more
Patient reported mild headache after ~10 minutes after vaccine administration, and lip numbness ~15 minutes after vaccine administration. Vitals 167/52, O298%, HR 67. Patient was evaluated by Dr. ~20 minutes after administration and monitored for 45 minutes. Headache and lip numbness resolved during observation period. Patient remained well appearing throughout. Reviewed s/sx anaphylaxis, advised her to call 911 if these occur at all today.
33 2021-02-09 mouth tingling Tongue tingling; Tachycardia/heart racing; HR was around 105-110 and bounding for about 1 minute; Na... Read more
Tongue tingling; Tachycardia/heart racing; HR was around 105-110 and bounding for about 1 minute; Nausea; This is a spontaneous report from a contactable other HCP (healthcare professional) who responded to an HCP letter that was sent. A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EK9231) intramuscularly on 09Jan2021 at 14:00 (at the age of 33-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was reported as none. Concomitant medications included drospirenone/ethinylestradiol (OCELLA) taken as an oral contraceptive (OCP) from 04Jan2021 to an unspecified date and cetirizine hydrocholoride (ZYRTEC ALLERGY) taken as a premedication for 3 days prior to 2nd dose. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EK5730) intramuscularly on 19Dec2020 at 13:00 (at the age of 33-years-old) in the left arm and experienced tingling of left arm, paresthesia of tongue, heart racing, feeling of lump in my throat and anaphylactic reaction. The patient previously received Bactrim on an unspecified date and experienced allergy. Prior vaccinations within 4 weeks were reported as not applicable and it was reported that the patient had not received any other vaccines around the time of the COVID-19 vaccine. The patient experienced "tongue tingling" on 09Jan2021, "tachycardia/heart racing", "HR (heart rate) was around 105-110) and bounding for about 1 minute" and "nausea" in Jan2021. It was reported that "I was re-dosed with the vaccine dose on 19Jan2021 (as reported) at 2pm. I took Zyrtec (Cetirizine) for 3 days prior. About 5 minutes after the vaccine was administered, I had tongue tingling that lasted approximately 5 minutes, I took 25mg of Benadryl and the tingling did not reoccur." It was also reported that "nausea occurred immediately after vaccine administration". The patient stated that her "heart was racing approximately 6-7 minutes after and lasted about 1 minute". It was reported that none of the events were considered serious due to being life-threatening or due to persistent or significant disability/incapacity. The adverse events did not require a visit to the emergency room or physician office and did not require medical intervention. The patient was not hospitalized due to the events. The patient was not admitted to an intensive care unit. It was reported that the patient did not have any bilateral wheeze/bronchospasm, stridor, upper airway swelling, respiratory distress, tachypnea, increased use of accessory respiratory muscles, recession, cyanosis, grunting, dry cough, hoarse voice, difficulty breathing, sensation of throat closure, sneezing, rhinorrhea, measured hypotension, shock, capillary refill time greater than 3 seconds, reduced central pulse volume, decreased level of consciousness, loss of consciousness, generalized urticaria, generalized erythema, angioedema, generalized pruritus with skin or without skin rash, localized injection site urticaria, red and itchy eyes, diarrhea, abdominal pain or vomiting. Relevant tests were reported as not applicable. It was also reported that a culture was not performed. The clinical outcomes of the events "tongue tingling", "tachycardia/heart racing", "HR (heart rate) was around 105-110) and bounding for about 1 minute" and "nausea" were all recovered/resolved on unspecified dates. The reporter considered that there was a reasonable possibility that the events were related to BNT162B2.
33 2021-02-13 visual impairment, light flashes or floaters in the eye, vision blurred, eye floaters Visual disturbances 3 days after 2nd Pfizer dose - Floaters in the middle of my visual field wouldn'... Read more
Visual disturbances 3 days after 2nd Pfizer dose - Floaters in the middle of my visual field wouldn't move and blurred my vision. Flashes/swirls of light. Struggled to read text. This lasted 2 hrs or so and finally gradually improved. I have NEVER had anything like this before. My mom had this EXACT same thing happen 2 days after her 2nd Moderna dose except hers hasn't gone away.
33 2021-02-14 deafness Chills, no fever, pulled my back in the morning with blinding pain/hearing loss, mostly recovered by... Read more
Chills, no fever, pulled my back in the morning with blinding pain/hearing loss, mostly recovered by next day (14th) now feels like a regular pulled muscle
33 2021-02-14 eye pain, blindness in both eyes Won't let me type everything. Long story short. Face tingled for a few days after shot, forehead ski... Read more
Won't let me type everything. Long story short. Face tingled for a few days after shot, forehead skin got tight and dry, now I've lost vision in my right eye! Today is exactly 2 weeks after 1st vaccine and sight in my right eye is worse and painful
33 2021-02-15 lip swelling throat tightness, lower lip swelling, mild chest tightness. Mild Angioedema
33 2021-02-15 bloodshot eyes, eye pain My autoimmune disorders were generally in remission. About a day after vaccination, I started experi... Read more
My autoimmune disorders were generally in remission. About a day after vaccination, I started experiencing severe joint pain in my hands, feet and sternum, my eczema on my stomach, chest and face, I began having bloody stools and developed giant papillary conjunctivitis (the last occurred 10 days after vaccination). Most have calmed down naturally within 2 weeks.
33 2021-02-15 tongue discomfort Tongue felt swollen and dizzy after vaccine. Evaluated by EMS. Pulse ox 99% BP 100/62 To stay extra... Read more
Tongue felt swollen and dizzy after vaccine. Evaluated by EMS. Pulse ox 99% BP 100/62 To stay extra 15 minutes. Benadryl and ER prn. Client felt better and went home.
33 2021-02-15 vision blurred, hearing loss 24 hrs after the vaccine I was about to have lunch and started feeling dizzy, couldnt hear the peopl... Read more
24 hrs after the vaccine I was about to have lunch and started feeling dizzy, couldnt hear the people in the room and began to fall as I was advised and someone in the room caught me. I was laid down and administered water until I felt better. I went back to my worksite while having to use the hand rails because my vision was blurred and I finally made it to my desk. I was then transported to the ER and my BS was taken which was 85. I was given IV fluids, a chest xray was performed, a UA and pregnancy test was done, EKG and a CBC done which all was negative and normal. From my knees down felt shaky the remainder of the week. I had a visit with my PCP the following week on Tuesday and had a sugar test done which was also normal and by the end of that week all symptoms had resided
33 2021-02-16 loss of smell Reported loss of smell 24 hours in, headaches, and fatigue.
33 2021-02-16 ear pain, fluid in middle ear Vertigo, dizziness, joint pain, rash, foggy brain, inability to speak, think and memorize as normal.... Read more
Vertigo, dizziness, joint pain, rash, foggy brain, inability to speak, think and memorize as normal. Sore throat, fluid in ears and lungs. Muscle weakness, headaches...difficulty walking. Insomnia. Flu like symptoms for 2 weeks after dose2. Nerve pain (shooting sensation down both arms. Difficulty standing for more than a few minutes, light headed. Ear pain, nausea, night sweats and unable to grasp normally. Tingling in face. Numbness in face.
33 2021-02-17 burning mouth syndrome, lip swelling, mouth tingling, swollen tongue "Received vaccine around 12:30pm. Around 8pm lips/tongue started tingling and swelling. Tongue broke... Read more
"Received vaccine around 12:30pm. Around 8pm lips/tongue started tingling and swelling. Tongue broke out in sores. Took 4-5 doses of Benadryl from 8pm on 1/19/21 to 1pm on 1/20/21, swelling resolved, some sores still present." The employee was placed "off work" from 1/20/21-1/23/21 and was prescribed one tablet daily of Zyrtec or Allegra over the counter.
33 2021-02-17 mouth numbness, mouth tingling started to feel a little lightheaded like my blood sugar was low; started to feel a little lighthead... Read more
started to feel a little lightheaded like my blood sugar was low; started to feel a little lightheaded like my blood sugar was low; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; some mild numbness of my tongue, face, and scalp; some mild numbness tongue, face, and scalp; some mild numbness tongue, face, and scalp; headache; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3248), via an unspecified route of administration on 21Jan2021, on 15:45 as single dose for covid-19 immunisation . The patient medical history was not reported. Concomitant medications included multivitamin. No other vaccines were given within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and experienced allergies, amoxicillin and experienced urticaria. on 22Jan2021, at 17:30, the patient started to feel a little lightheaded like my blood sugar was low, tongue started tingling, which then progressed to lips, face, and then halfway back the scalp, some mild numbness of my tongue, face, and scalp and headache; the events were reported as non-serious. The events were elaborated as follows: the patient indicated started to feel a little lightheaded like her blood sugar was low. About 15 minutes after, she had initially started to feel lightheaded, her tongue started tingling, which then progressed to her lips, face, and then halfway back of her scalp. The paresthesias were intermittent in those areas and then some mild numbness of the tongue, face, and scalp followed. All the symptoms subsided after about 30-40 minutes. She said she may have had a mild headache afterwards. No motor symptoms were noted. Purely sensory and it seemed in the trigeminal nerve distribution. The outcome of the events was 22Jan2021; no symptoms have occurred since the 22Jan202. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.
33 2021-02-17 mouth tingling approx 3:30 pm she got her covid vaccine. Shortly after she had a rash over her face and felt tingli... Read more
approx 3:30 pm she got her covid vaccine. Shortly after she had a rash over her face and felt tingling around her tongue. She was given benadryl and sent to the ED for further evaluation. She states that she had some heaviness over her chest initially but that this is gone as well. Pt given a dose of famotidine 40mg PO x1; SX's resolved and dc home on Epi pen, famotidine and diphenhydramine. Received 2nd dose on 1/9 with no reaction.
33 2021-02-18 deafness Sudden never hearing loss; This is a spontaneous report from a contactable other healthcare professi... Read more
Sudden never hearing loss; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EJ1685), via an unspecified route of administration at the left arm on 20Jan2021 10:00 at single dose for COVID-19 immunization. The vaccine was administered in the hospital. The patient medical history was not reported. The patient was not pregnant. There was no other vaccine in four weeks. Prior to vaccination the patient had no COVID. The patient has not tested for COVID post vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC) and hctz. On 21Jan2021, the patient experienced sudden never hearing loss. It was reported that the event resulted to doctor or other healthcare professional office/clinic visit and Disability or permanent damage. The patient received an oral steroid as treatment. The outcome of the event was not recovered.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, a possible contributory role of the suspect BNT162B2 in triggering the onset of sudden never hearing loss cannot be excluded. Additional information regarding relevant medical history, etiologic and diagnostic work-up will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
33 2021-02-21 mouth tingling Patient c/o feeling lightheaded 5 minutes after administration. BP was normal. Gave cold water. Deve... Read more
Patient c/o feeling lightheaded 5 minutes after administration. BP was normal. Gave cold water. Developed itchy red rash across chest ~8 minutes after administration. This began to fade ~15 minutes after administration, but patient then complained that tongue felt funny & began clearing throat. After consulting with our NP, Epipen was administered (0.3mg), & 911 called. Transported via ambulance ED. Pt reported tongue feeling better after Epipen.
33 2021-02-25 ear pain, ear discomfort First 2 days upset stomach, then throbbing brain and ear clogged. On Saturday, I began to have spora... Read more
First 2 days upset stomach, then throbbing brain and ear clogged. On Saturday, I began to have sporadic sharp pain to the left side of my head and also experiencing stiffness/soreness of the left side of my neck; at times painful in my left ear when I swallow. 2/23 nausea and abdominal pain. ER visit on 2/24, meds ciprofloxacin optic, cyclobenzaprine and lidocaine patches. 2/26 pain in the back of my head.
33 2021-02-25 swollen tongue headache, dizziness, tongue swelling
33 2021-02-28 vision blurred brain fog; Bell's palsy on left side of face; vision has been off/ Vision is blurry; Numbness and ti... Read more
brain fog; Bell's palsy on left side of face; vision has been off/ Vision is blurry; Numbness and tingly/burning sensation in right leg; Numbness and tingly/burning sensation in right leg; Numbness and tingly/burning sensation in right leg; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9264 and Expiration Date: May2021), via an unspecified route of administration in the left arm on 02Feb2021 at 17:45 at 33-years-old at a single dose for COVID-19 immunization; with no other vaccines administered within four weeks of the bnt162b2 administration. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication from an unspecified date to an unspecified date, prednisone (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified date to 16Feb2021. The patient experienced the following events and outcomes: Bell's palsy on left side of face (medically significant) on 06Feb2021 12:00 with outcome of recovering, vision has been off/ vision is blurry (medically significant) on 06Feb2021 12:00 with outcome of recovering, numbness and tingly/burning sensation in right leg (medically significant) on 06Feb2021 12:00 with outcome of recovering, brain fog (medically significant) on an unspecified date with outcome of unknown; all of which required a physician office visit. The clinical course was reported as follows: The patient received the first dose of the Pfizer COVID 19 vaccine, she began having symptoms on the following Saturday and was seen by her doctor and diagnosed with Bell's Palsy. The patient stated she has reported this via VSafe and the Pfizer website. The patient also reported other symptoms that have not been reported as follows: had tingling in both legs, brain fog, and vision has been off. The patient was not sure if it was related to the vaccine or steroids. The patient wanted to know if she should get the second dose. The patient had been on a steroid, so she did not know if she should wait to get the second dose. The patient just stopped the steroid on 16Feb2021, and the second dose was scheduled for 23Feb2021. The patient also said she had other symptoms that she had not reported and she said she had tingling that started in one leg now in both legs, brain fog and her vision was off and she was not sure if that was related to the vaccine or the steroid (later clarified as prednisone). The patient was not taking the steroids at the time of diagnosis. "Correct I mean it started after the vaccine, but I was also on medication (Clarified as Prednisone) so I am not really sure what the difference is at this time." Treatment in response to event: the patient stated, "No I mean for the tingling in my leg I have been just putting heat and Ice on it but I have not done anything actual big treatment and then for my eyes no, my doctor is not sure what is related to the Bell's Palsy and what is to medication." The patient underwent lab tests and procedures which included lab work: unknown result on an unspecified date (patient stated, "Yes, I have many"). Therapeutic measures were taken as a result of facial paralysis, hypoaesthesia, burning sensation, and paraesthesia; which included steroids and anti-viral and anti-nausea medicine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.
33 2021-03-01 mouth tingling Lightheaded; tongue tingling; slight difficulty swallowing; occasional cough. Evaluated by emergency... Read more
Lightheaded; tongue tingling; slight difficulty swallowing; occasional cough. Evaluated by emergency department.
33 2021-03-02 eye swelling I started feeling sick 7 hrs after the vaccine I developed chills, fevers, fatigue. My fever went up... Read more
I started feeling sick 7 hrs after the vaccine I developed chills, fevers, fatigue. My fever went up to 102.9, my eyes started to swell, I felt congestion. I went to the ER on 1/11/201 at around 11pm they gave me medications. The next day I also had diarrhea. The fevers resolved by the following day the body aches & the chills lasted for 1 week & the diarrhea lasted for 1 day. Fatigue is still going on & off it has not completely resolved.
33 2021-03-02 fluid in middle ear Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normal... Read more
Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient). A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-03-03 mouth numbness Patient was administered Pfizer Covid vaccine and within a few minutes, tongue became numb. Patient ... Read more
Patient was administered Pfizer Covid vaccine and within a few minutes, tongue became numb. Patient administered benadryl and made to wait in the IMZ area for 30 extra minutes. Reaction did not resolve, but did not progress.
33 2021-03-03 feeling of choking, mouth tingling, lip swelling Within ten minutes of receiving her COVID 19 vaccine the patient experienced tingling in her lips. ... Read more
Within ten minutes of receiving her COVID 19 vaccine the patient experienced tingling in her lips. She received 10 mg of Zyrtec and ten minutes following medication administration her symptoms progressed to tingling in her throat and lip swelling. Epi-Pen was administered with good effect with ACC provider at bedside. 911 was called to transfer patient to nearest ED for observation and her care team was contacted to manage 2nd dose of vaccine when needed. VSS remained stable through event and patient remained alert and oriented with stable VS and airway.
33 2021-03-04 mouth numbness I received my first dose of the Pfizer COVID-19 Vaccine on 3/2/2021 in my left arm. After approx. 30... Read more
I received my first dose of the Pfizer COVID-19 Vaccine on 3/2/2021 in my left arm. After approx. 30 minutes of receiving my shot my left side of my face felt numb including the left side of my tounge as well as muscle pain and soreness on the left side on the back of my neck. Today is 3/5/2021, my face is slowly becoming less numb over time and rest. I also experienced fatigue and injection site soreness. I am particularly concerned about my face becoming numb shortly after receiving my vaccine and I am wondering if I should get a second dose when I need to?
33 2021-03-06 mouth tingling Throat swelling and closing, burning sensation on my face, and tingling lips (all reactions began ap... Read more
Throat swelling and closing, burning sensation on my face, and tingling lips (all reactions began approximately 10-15 min after injection). Provider at PHARMACY gave me oral Benadryl, which has helped, but I still don't feel 100% (it has been 1 hour 45 minutes)
33 2021-03-07 ear pain, ear swelling Blisters/Shingles/positive for Varicella zoster virus DNA, PCR; rash; ear started swelling; lymph no... Read more
Blisters/Shingles/positive for Varicella zoster virus DNA, PCR; rash; ear started swelling; lymph node swelling under her ear/lymph swelling increased to quarter size; shooting pain in my right ear; Headache; chills; This is a spontaneous report from a non-contactable healthcare professional (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) intramuscular on 27Jan2021 15:30 in left arm at single dose for COVID-19 immunization. The patient did not have Covid prior vaccination. The patient did not have covid tested post vaccination. No known drug allergies and no other medical history. The patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced headache and chills 3 days after Covid vaccine on 30Jan2021. On 03Feb2021, she had shooting pain in her right ear. On 04Feb2021, her ear started swelling, she also noticed her lymph node swelling under her ear. On 05Feb2021, chills, lymph swelling increased to quarter size with a rash under her jaw line and earlobe; she made an appointment with her PCP and was given Ceftin 500 mg two times a day for 7 days. She had blisters on the back of her earlobe on 07Feb2021. On 07Feb2021, she noticed more blisters in front of her right earlobe and on the rash under her jaw line. On 07Feb2021, she went to urgent care and was diagnosed of shingles, given valacyclovir (VALTREX) 1 mg three times a day for 7 days. On 10Feb2021, culture came back positive for Varicella zoster virus DNA, PCR. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
33 2021-03-10 dry mouth DRY MOUTH, HEADACHE, PAIN AREA OF THE RIBS THAT OPPRESSES, PAIN AND BURNING IN CHEST. ELEVATED PULSE... Read more
DRY MOUTH, HEADACHE, PAIN AREA OF THE RIBS THAT OPPRESSES, PAIN AND BURNING IN CHEST. ELEVATED PULSE, HEADACHE, MUSCLE AND EXTREMITIES PAIN. "CURRENT IN THE CHEST". NORFLEX 60 MG IM X1 WAS ADMINISTERED. BENADRYL 25MG PO X1
33 2021-03-10 dry throat The patient received 2nd dose of Pfizer Covid vaccine in left upper arm at 1230 today. While she was... Read more
The patient received 2nd dose of Pfizer Covid vaccine in left upper arm at 1230 today. While she was sitting in the waiting area for monitoring, she soon developed a sore/dry throat, difficulty breathing, and felt "strange". She also felt itchy, but had no local injection site reaction, rash, or hives. The first dose of epinephrine administered at 1251; patient developed a dry cough, anterior throat pain with difficulty swallowing, HA, dizziness, and chest heaviness. A second dose of epinephrine was given at 1301. EMS administered 25 mg of IV benadryl, and she started to have relief of her symptoms. She denies any nausea, vomiting, or palpitations. The patient states her throat still feels sore and itchy, but there is no obvious swelling at this time. She was monitored in the Emergency Department and discharged home.
33 2021-03-10 enlarged tonsils The day after the 2nd pfizer dose I experienced fever, chills, swollen tonsils, swollen axillary lym... Read more
The day after the 2nd pfizer dose I experienced fever, chills, swollen tonsils, swollen axillary lymph nodes, and nausea. The symptoms subsided the following day but the next day (3 days post vaccination) I experienced extreme vertigo and dizziness that lasted hours. It is not 1 week and 1 day post vaccination and I still experience mild dizziness and vertigo that comes and goes without cause or warning.
33 2021-03-14 light flashes or floaters in the eye On 2/25/2021 I experienced vision problems. It was like lashing lights this happened 2 days on the 2... Read more
On 2/25/2021 I experienced vision problems. It was like lashing lights this happened 2 days on the 2/25/2021 & on 2/26/2021. I had to see my eye doctor. Pregnancy due date 4/29/2021 & my pregnancy has been good just got diabetes .
33 2021-03-15 ringing in ears Intense ringing in ears, primarily left ear; This is a spontaneous report from a contactable healthc... Read more
Intense ringing in ears, primarily left ear; This is a spontaneous report from a contactable healthcare professional, the patient. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL9266, first dose) solution for injection intramuscular in the right arm on 12Feb2021 at 15:00 (at the age of 33-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included Charcot Marie tooth. Concomitant medication included intrauterine contraceptive device (IUD). The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced intense ringing in ears, primarily left ear on 12Feb2021, it began about 3 hours after vaccine and was still occurring 18 hours later. No treatment was provided for event intense ringing in ears. The outcome of the event intense ringing in ears was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
33 2021-03-15 vision blurred 33y/o female presents with difficulty swallowing <10min after receiving the Pfizer vaccine in the le... Read more
33y/o female presents with difficulty swallowing <10min after receiving the Pfizer vaccine in the left arm on 3/16/21. She reports associated throat tightening, difficulty swallowing liquids, shortness of breath, nasal congestion, upper extremity/chest tingling, blurring of vision and feelings of anxiety. She denies lip/tongue swelling/tingling, itching or pain at site of injection. She has h/o allergies to shellfish, cats and bees. No known allergies to medications. Physical Exam: Vitals: BP 174/122, HR 78bpm Skin: non-pruritc erythematous rash of chest, generalized light redness of upper extremities bilaterally. No itching. Cardiac-regular heart rate and rhythm. Radial pulse 2+ Lungs-clear to auscultation bilaterally Plan: EMS was contacted immediately when PT reported difficulty swallowing. EMS placed patient in the ambulance at ~6pm and transported patient to Doctor's Hospital.
33 2021-03-16 dry mouth, mouth tingling - HR spiked within first few minutes of shot; fluctuated up to 180 that day. Both hands were immedi... Read more
- HR spiked within first few minutes of shot; fluctuated up to 180 that day. Both hands were immediately weak and aching. Went to ER to monitor for reaction. - Continuing elevated HR episodes for first week; strong left arm pain?couldn?t move or touch for first few days - Panic attack-like responses approx. once per day for first week. Rush of heat through hands, throat, face, rapid HR, dizziness - Increasing joint and muscle pain; also describe as a deep ?bone pain.? Started in feet, wrists/hands and progressed to both legs, hips, back, neck. Acceleration of symptoms starting on or about 3/14. - Saw PCP multiple times for pain; went to ER on 3/16 for severe pain, weakness. Have been confined to bed or in bath with Epsom salts due to pain. Starting steroid treatment and nerve pain treatment today 3/17. - Also experiencing extreme dry mouth and clamminess. For first week after shot, had tingling/irritated feeling in my tongue any time I ate or drank ? no changes in diet.
33 2021-03-17 bloodshot eyes, swelling of eyelid, eye itchiness Pain and swelling of the right eyelid. Started about 48 hours after the first dose was administered ... Read more
Pain and swelling of the right eyelid. Started about 48 hours after the first dose was administered and had been getting progressively worse over the next 48 hours. Talked to my PCP and a nurse over the phone and through one chart. Treating the symptoms as a stye seem to be helping. Ibuprofen, eye drops, and a product called stye have been helping reduce the symptoms, especially the pain. A hot, wet washcloth is even more helpful. Used it for almost an hour this evening and the swelling is way down. My eyes themselves are actually starting to itch and look red tonight. This is the first time this has happened lately. I have seasonal allergies, but this whole thing experience has felt entirely different from that kind of swelling. I've never had swelling of this nature before. Or any adverse reactions to vaccines (aside from minimal soreness near the injection site).
33 2021-03-17 swelling of eyelid Day 4 - large warm red spot on left arm below injection site Days 5-6 - eyes swollen halfway shut, g... Read more
Day 4 - large warm red spot on left arm below injection site Days 5-6 - eyes swollen halfway shut, general face swelling, redness, itching and burning
33 2021-03-17 swollen tongue Heart racing, extreme lightheadedness and dizziness, extreme sweating, numb/tingly arms and hands, m... Read more
Heart racing, extreme lightheadedness and dizziness, extreme sweating, numb/tingly arms and hands, moderately swollen tounge.
33 2021-03-17 thirst thirsty sensation, dizzy, throat hoarse, denies any breathing problems,
33 2021-03-18 mouth tingling, mouth numbness chest tightness, wheezing, anxiety, lasting 2 hours. Since this time I have noticed my tongue feels ... Read more
chest tightness, wheezing, anxiety, lasting 2 hours. Since this time I have noticed my tongue feels like it is burnt and sometimes numb (2 months now)
33 2021-03-19 ear pain On the second day of the vaccine, I experienced a severe headache, muscle pain in both of my legs, a... Read more
On the second day of the vaccine, I experienced a severe headache, muscle pain in both of my legs, and a mild fever, on Wednesday I felt better, but on thursday I began to have a mild headache with shooting pain to the back of my head near my right ear and it has been painful ever since.
33 2021-03-19 lip swelling 33 yr.. female AAO x4, CC possible allergic reaction. Pt. had Pfizer Covid-19 vaccination (lot EP695... Read more
33 yr.. female AAO x4, CC possible allergic reaction. Pt. had Pfizer Covid-19 vaccination (lot EP6955 exp 06/31/21) and started to experience some tightness in her throat. Paramedics on site evaluated and of medical site lead a decision was made to activate EMS due to pt. advising her bottom lip was swelling a little and her voice was changing slightly. Crew showed up scene, evaluated pt. and got an AMA release with the caveat that her mom would drive her direct to the hospital. On site paramedics also advised pt. Had wheezing in upper R lobe, which resolved upon arrival. Pt. has medical hx of anaphylaxis to peanuts (carries EpiPen) and bipolar type ii disorder, medications of Lamictal and bupropion. Tx: pt was administered 25 mg Benadryl PO . Pt was further evaluated with course listed as above. Vitals were BP 110/72, P 90 R 16 97% on RA Pox. Follow-up: pt went, was seen in ED and was given diphenhydramine, Pepcid and a steroid. Pt. discharged to home with no further incident. Pt. advised to advise vaccination staff of reactions she had for second appointment.
33 2021-03-19 mouth tingling Immediately after vaccination, patient reported, "tingling of the tongue". Patient denied difficulty... Read more
Immediately after vaccination, patient reported, "tingling of the tongue". Patient denied difficulty breathing, tongue swelling, and shortness of breath. Patient does not appear in respiratory distress. Patient educated on possibility of adverse reaction and need to increase post-observation time to 30 minutes. Patient offered diphenhydramine PO with water. Patient educated on indication for diphenhydramine and accepted medication. Patient re-assessed and symptoms subsided. Patient is resting comfortably in observation site and educated to seek emergency medical attention if symptoms worsen.
33 2021-03-21 eye pain, visual impairment I started experiencing innappropriate affect and lost control of emotions. I would cry innappropriat... Read more
I started experiencing innappropriate affect and lost control of emotions. I would cry innappropriately or laugh at things innappropriately. I began experiencing brain fog and memory loss. Then i began experiencing vertigo that impaired my spacial reasoning. On Tuesday 3/9 I lost the ability to see objects far away. on 3/10 I woke up and was unable to read close up, or distinguish letters. The vision and vertigo has continued. I have to shut my eyes completely to walk without becoming sick. I can not be in a busy room with movement or my eyes will hurt. I can not read anything with font smaller then size 18. I can not watch TV because i can no longer see far away. I can not drive a car due to the motion., and i cant see the objects as they move.
33 2021-03-21 tunnel vision Feeling dizziness, tunnel visioning
33 2021-03-22 oropharyngeal discomfort, mouth tingling Shortly after vaccination patient reported heart racing, panic, tingling on tongue, and cold throat.... Read more
Shortly after vaccination patient reported heart racing, panic, tingling on tongue, and cold throat. Transported to ER by EMS.
33 2021-03-22 smell distorsion I had an odd smell sensation of an electrical burning smell (like that of an electric stove). It hap... Read more
I had an odd smell sensation of an electrical burning smell (like that of an electric stove). It happened twice in the 2-3 days after getting the vaccine.
33 2021-03-22 swollen tongue, lip swelling It started about 20 minutes after vaccination. I started to feel a rush of heat like a hot flash and... Read more
It started about 20 minutes after vaccination. I started to feel a rush of heat like a hot flash and my heart was racing while I was driving home. My cheeks and lips were swelled up. My tongue was starting to swell but I could still breathe. I was wheezing so I took a Benadryl and then took another four hours later. I felt very light headed for the rest of the day. The light headedness and dizziness stayed for a few days with a headache. I did not have second dose on the recommendation of my doctor. I ended up contracted Covid-19 three weeks after the vaccine.
33 2021-03-22 ringing in ears I have had ringing/tinnitus in my left ear since 2/13/21.
33 2021-03-22 visual impairment, swollen tongue While I was waiting during the 15 minute window, I started to feel light headed and saw black spots.... Read more
While I was waiting during the 15 minute window, I started to feel light headed and saw black spots. I told the nurse I didn't feel well and wanted to wait a little longer. Within 10 minutes or so, I started to experience tingling sensation all over my face and then it spread to my neck and then to the rest of my body. My face started to feel stiff and I became really hot. My tongue felt swollen and my entire jaw felt very stiff. I lost my ability to speak and then eventually had full body paralysis. I could not move any limb. I could hear and see, but I could not verbalize a response or move any part of my body. I remained in this state for about 1.5 hour. Afterwards, I regained my motor skills and my speech.
33 2021-03-24 sensitivity to light Sharp squeezing frontal headache about 3am. Woke around 6am with headache and light sensitivity, sor... Read more
Sharp squeezing frontal headache about 3am. Woke around 6am with headache and light sensitivity, sore body. Went back to bed about 8am, woke at 9am vomiting, headache, slow moving. Took ibuprofen went back to bed. Woke at 11:30am vomiting again. Back to sleep shortly after.
33 2021-03-25 blindness One hour after vaccination my chest tightened and I started losing vision. I was driving and pulled... Read more
One hour after vaccination my chest tightened and I started losing vision. I was driving and pulled to the side of the road, felt I needed to pay down and opened the car door and passed out on the pavement. After regaining consciousness I got in the car and felt a second wave coming , called 911
33 2021-03-25 taste impairment Client received her first dose of Pfizer vaccine and thereafter reported a metallic taste in her mou... Read more
Client received her first dose of Pfizer vaccine and thereafter reported a metallic taste in her mouth. She was asked to wait for 30 minutes, at the end of which she reported feeling queasy. She went to the bathroom and tried to throw up, but she only had dry heaves. Vital signs: BP=119/91, Pulse=81, Respiration=18. She was asked to wait another 15 minutes to observe for progression of her symptoms, but at the end of that time she stated that she felt fine, her symptoms had improved and she was ready to leave. She was asked to call ?911? if the symptoms returned and was also asked to share her reaction to the vaccine with her Primary Care Physician, and she voiced understanding.
33 2021-03-25 taste impairment Approximately 10 minutes after injection patient started to complain of an itchy throat and a metall... Read more
Approximately 10 minutes after injection patient started to complain of an itchy throat and a metallic taste in her mouth. No acute distress noted. No oral, facial or throat swelling noted. Lungs clear bilaterally and patient moving air without difficulty. Skin warm and dry. Patient speaking clearly and in full sentences. Patient continued to be monitored. Patient complained of slight chest "tightness" and increased mucus production approximately 20 minutes after initial vaccination. Upon exam no acute distress noted. Lungs clear bilaterally. Skin warm and dry. Patient speaking clearly and in full sentences. Patient able to manage oral secretions, no drooling noted. No oral, facial or throat swelling noted. No notable redness or rash observed. EMS called and arrived without incident. Patient discharged by EMS and was advised by them to go home and take a benadryl. Discussed EMS recommendation with patient and she verbalized understanding and stated that she would call 911 or go to ER if symptoms change or worsen.
33 2021-03-27 tongue itchiness, mouth numbness, swollen tongue 25 min after shot, my tongue swelled up and mouth was numb for 5 min. Next morning my tongue is stil... Read more
25 min after shot, my tongue swelled up and mouth was numb for 5 min. Next morning my tongue is still swollen and itchy and little rash on my chin.
33 2021-03-27 vision blurred Lightheaded Blurred vision ALS assessment completed with Sinus on monitor . After sitting in Ambulan... Read more
Lightheaded Blurred vision ALS assessment completed with Sinus on monitor . After sitting in Ambulance , pt states feeling better and denies transport to hospital. Pt signed refusal , left in own care. VS 70/41, 85, 20 O2 sat 99 %, 90/55, 88, 16 O2 sat 99 %, 98/60, 86, 18, O2 sat 99 %.
33 2021-03-28 ear pain After receiving the first vaccine, started experiencing a little neck pain and swelling on and off f... Read more
After receiving the first vaccine, started experiencing a little neck pain and swelling on and off for 2 month since first vaccination on December 30th. After second dose of Pfizer, the swelling and pain in the neck escallated and three nodules were discovered in my neck at ER visit due to pain from neck and radiating in ears and head. Extremely fatigued and headache was unbearable. ER MD discovered nodules, high white blood count, etc. Sent to follow up with Endo. Endo could not explain. Thyroid labs are all normal but the symptoms and nodules makes this suspicious. ANother ER visit with 3 days hospitalization due to pain and now elevated pulse (even while sitting in ER bed at 135-140 pulse). Low grade fever, nausea, vomiting, lethargic, elevated labs, etc. Now on propranolol for heart regulation and prednisone to monitor. Multiple CT scans and Ultrasound confirmed the nodules.
33 2021-03-28 swelling around the eyes, ear swelling I became very itchy, my face reddened, my left ear swelled, and it felt puffy under my left eye. It... Read more
I became very itchy, my face reddened, my left ear swelled, and it felt puffy under my left eye. It went away after about 7 hours
33 2021-03-28 ringing in ears, deafness hearing loss; Tinnitus in left ear/Crackling sound and ringing in ear; dullness; This is a spontaneo... Read more
hearing loss; Tinnitus in left ear/Crackling sound and ringing in ear; dullness; This is a spontaneous report from a contactable consumer (reporting for herself). A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204, expiration date: unknown), via an unspecified route of administration in left arm on 05Mar2021 at 14:00 as SINGLE DOSE for COVID-19 immunization. The patient's medical history included Crohn's Disease, anxiety, and penicillin allergy. Concomitant medication included amitriptyline and celecoxib (CELEXA), both for unspecified indication. On 07Mar2021, the patient experienced tinnitus in left ear, crackling sound and ringing in ear, dullness and some hearing loss. The outcome of the events was not recovered.
33 2021-03-31 ear swelling Left side of body slightly swollen: arm, hand, leg, foot, ear.
33 2021-03-31 lockjaw 1/11 vaccination 1/18 I woke up I was talking to my cousin I noticed like I had a Charlie horse in m... Read more
1/11 vaccination 1/18 I woke up I was talking to my cousin I noticed like I had a Charlie horse in my mouth. My jaw was tightening on one side. I immediately talked to my siblings and they said to take ibuprofen up to 800 mg daily. Those symptoms lasted for less then a week. 'lock jaw syndrome'
33 2021-04-01 taste impairment, mouth numbness Patient received vaccine at 5:29pm. She immediately reported a funny taste in her mouth. She was mon... Read more
Patient received vaccine at 5:29pm. She immediately reported a funny taste in her mouth. She was monitored for 15 minutes. At 5:44PM the patient still had a funny taste in mouth, but no other symptoms. When pressed further she said she had some numbness in her tongue, but no swelling or tingling. The patient was given 50mg Benedryl by mouth and then monitored for 15 additional minutes. At 6pm the patient stated that she felt better and wanted to go get something to eat. At that point I let her leave the immunization area.
33 2021-04-01 ear discomfort Dizziness, blocked ear drum, sinus pressure.
33 2021-04-01 extreme sound sensitivity, vision blurred I ultimately suffered from Acute Disseminated Encephalomyelitis and was hospitalized for 5 days due ... Read more
I ultimately suffered from Acute Disseminated Encephalomyelitis and was hospitalized for 5 days due to brain and spine inflammation. I had numbness in my feet 2 days after my vaccine, then suffered from dizziness and nausea 3 days after my vaccine, and had face paralysis 4 days after my vaccine. I went to the ER 4 days after the vaccine and was told I have Bell's Palsy and Vertigo. I was prescribed oral steroids and anti-nausea medicine. In the following weeks, I had more tingleness/numbness of the legs, brain fog and confusion, blurred vision, unsteady gait, loss of balance, blurred vision and leg muscle weakness, increased anxiety, hearing sensitivity, lethargy, sleeplessness, 6th cranial nerve palsy, tingles in the face, and headaches. I finally got an MRI and when doctor?s saw the MRI results 3 days later, I was told to go to the ER immediately because I had brain and spine inflammation that needed treatment, and was diagnosed with ADEM. I then spent 5 days in the hospital to receive intravenous steroids and monitoring. During this stay, I had more MRIs and a lumbar puncture. I was released on oral steroids for 25 days, as well as follow up appointments and monitoring progress in recovery. Inflammation has decreased. I continue to have tingleness in lower extremities, headaches, pain in legs, and sensitive hearing.
33 2021-04-02 mouth tingling, mouth swelling app 18 min after injection pt started feeling tingling/swelling in mouth, denied sob. pt was given ... Read more
app 18 min after injection pt started feeling tingling/swelling in mouth, denied sob. pt was given benadryl 25mg po on onset of sx, dose repeated app 5 min later
33 2021-04-02 swelling around the eyes Client complained of tightness in the throat region, eye puffiness and transient right arm urticaria... Read more
Client complained of tightness in the throat region, eye puffiness and transient right arm urticaria. On site MD recommended Benadryl but client declined. Client held for observation and symptoms resolved. Client released by MD in stable condition.
33 2021-04-03 mouth swelling Face became numb and skin flushing within 10 min of vaccination. Mouth started swelling within 15 mi... Read more
Face became numb and skin flushing within 10 min of vaccination. Mouth started swelling within 15 minutes post vaccination. 50mg Benadryl orally dosed at clinic then rushed over to the ER. Doctor diagnosed with adverse reaction and gave another 25mg benadryl IM, decadron 8mg and famotidine 20mg. Was released after an hour of monitoring in the hospital. Had to stay on Benadryl and famotidine for 3 days around the clock. Adrenaline was constantly going for that long as well.
33 2021-04-04 taste impairment - metallic taste in mouth (continuous) - tightened chest (day 1 - 2) - headache (day 1) - nausea (da... Read more
- metallic taste in mouth (continuous) - tightened chest (day 1 - 2) - headache (day 1) - nausea (day 1 - evening)
33 2021-04-05 pain in jaw Throat swelling (lymph nodes), pain-jawbone. Evaluated be EMS-Refusal to transport.
33 2021-04-06 hearing loss, tunnel vision the back (mostly left side) of her head gets so tight and sore; felt like the back of her skull was ... Read more
the back (mostly left side) of her head gets so tight and sore; felt like the back of her skull was fractured/the back (mostly left side) of her head gets so tight and sore; all color drained from her face; tunnel hearing; tunnel vision; felt the worst feeling about to faint; felt a "static" feeling all over her body; throwing up; fever; migraine; aches; Chills; hot sweats; This is a spontaneous report from a contactable consumer (the patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6207), via an unspecified route of administration in the left arm on 13Mar2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma and lactose Intolerance- not allergy though (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: fluticasone propionate/ salmeterol xinafoate (ADVAIR), loratadine, bupropion hydrochloride (WELLBUTRIN), and vitamins (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6200), via an unspecified route of administration in the left arm on 20Feb2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient stated that 24 hours after her second dose (14Mar2021 12:00), she felt the worst feeling about to faint, all color drained from her face. She got tunnel vision/hearing and felt a "static" feeling all over her body. Then started throwing up. She took a nap and woke up an hour later with 101.2 (degree) fever (14Mar2021) and fought that, along with migraine, aches, chills, hot sweats (14Mar2021). About 8 hours after initial fever (14Mar2021), it spiked to 102.4 (degree) for two hours. It came down quick. The next day, 15Mar2021, it felt like the back of her skull was fractured. And since then (unspecified date), the back (mostly left side) of her head gets so tight and sore especially when laying down. She has been sleeping on heating pad for 10 days now, and it got a little better but still super sore (head). The events involved a doctor or other healthcare professional office/clinic visit. Treatment was received for the back (mostly left side) of her head gets so tight and sore. There was no treatment for the other events. The outcome of the events was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
33 2021-04-07 mouth numbness At 20mins after vaccine felt like the floor was coming up with out seeing it that way. About 40mins ... Read more
At 20mins after vaccine felt like the floor was coming up with out seeing it that way. About 40mins after vaccine left side of my face went numb. Into my lips, my entire cheek, up side of my eye. This was the same side as my vaccine. Lasted badly for almost 2 hours and started to fade. At 1.5 days these areas still feel odd/full/like a bandage is on them.
33 2021-04-08 loss of smell, loss of taste Beginning on the evening of April 8th, my ability to taste lessened. This morning, April 9th, I cann... Read more
Beginning on the evening of April 8th, my ability to taste lessened. This morning, April 9th, I cannot smell or taste anything. I have tried eating potent candied ginger as well as raw onion and cannot taste either one. I asked a family member, who is an RN, and she advised this is most likely just a temorary side effect as I am quite healthy otherwise. I always wear my mask, wash my hands often and thoroughly, and have stayed home whenever possible. I am unaware how long it will last, but hopefully it will go away soon.
33 2021-04-08 taste impairment Within seconds of receiving the vaccine, I had a strong metallic taste in my mouth. My husband and I... Read more
Within seconds of receiving the vaccine, I had a strong metallic taste in my mouth. My husband and I sat in our car for the 15 minutes required and I thought I was feeling a bit off, but also was trying to figure out if anyone else had experienced the metallic taste. After our 15 minutes wait period, we left to head back home. On the way home, about 30-40 minutes after I received the vaccine, I started to feel really warm. Then my neck started to feel really hot and when I swallowed it felt like I had a knot in my throat. As far as I know, I'm not allergic to anything, but realized there was something seriously wrong with my body and had my husband get off the freeway so I could get some water and possibly go to an urgent care. It also doesn't help that my heart was racing and I started panicking because it felt like my throat was starting to close up. When the initial anxiety of what was happening calmed down, we carefully drove home and I called the urgent care nurse line at my doctor's office. The nurse on the line told me to take a Benadryl and to take another one 6 hours later. He said that I was having an adverse reaction and if things got worse go into the ER . Luckily things calmed down after a while but the metallic taste stayed for two days. I've been advised to not get the 2nd dose, which I'm honestly not comfortable getting at this point either.
33 2021-04-08 mouth tingling Patient starts getting tingly lips after 5-10 minutes of administration and then facial swelling sta... Read more
Patient starts getting tingly lips after 5-10 minutes of administration and then facial swelling starts within a few minutes after the tingling lips. The pharmacy call 911 to get an ambulance for the patient, patient self administer 1 dose of Epipen 0.3mg injection. The ambulance came within 5-10 minutes and brought the patient to the hospital.
33 2021-04-08 visual impairment History of Present Illness This is a healthy 33-year-old female presenting to the emergency depa... Read more
History of Present Illness This is a healthy 33-year-old female presenting to the emergency depart with medics after having a syncopal event after getting the COVID-19 vaccine. She states that she was otherwise feeling well today, exercise on her Peloton bike today with no problems, received her COVID vaccine and shortly after her vaccine started to feel dizzy and light headed. She tells me she was reading an article on her phone about cats when she suddenly started to feel dizzy, lightheaded, felt like she could not see, and she could not feel her hands and legs. The next thing she remembers is receiving a shot of epinephrine. She denies any lip swelling, tongue swelling, rashes on her body, or extremity itchiness. Currently states that she feels like the back of her throat he has a little bit itchy. Denies any abdominal pain, headache, neck pain, or numbness or weakness at this time. She was given 0.3mg SQ epi x 2 in the pharmacy. When medics arrived on scene, she was awake, moving all extremities, lungs were clear bilaterally. Blood pressure was 130/90, heart rate was 100 (NSR). She tells me her two biggest complaints at this time is that she feels like her heart is racing after the epinephrine shot and she has some mild itchiness in the back of her throat. Reports she has a history of allergy to multiple medications and an allergy to the chickenpox vaccine.
33 2021-04-10 light flashes or floaters in the eye Vasposasm, flushing/sweating, dizziness, saw bright lights, pale, and HA. BP was 142/11 HR57, RR16. ... Read more
Vasposasm, flushing/sweating, dizziness, saw bright lights, pale, and HA. BP was 142/11 HR57, RR16. Patient recovered and was discharged in stable condition
33 2021-04-11 ear discomfort Extreme feeling of hotness for first two days Extreme tightness in trachea on day after- re-emerging... Read more
Extreme feeling of hotness for first two days Extreme tightness in trachea on day after- re-emerging two days after Puffy feeling in ears - with whooshing feeling
33 2021-04-11 mouth numbness, mouth tingling At 1 H post administration, the patient reported a sensation of numbness and tingling in the lips an... Read more
At 1 H post administration, the patient reported a sensation of numbness and tingling in the lips and nose. At 2 H post administration, the patient experienced hives, and a sensation of airway obstruction which resulted in an ER visit.
33 2021-04-11 taste disorder Rapid heart rate within 2 minutes of injection, the feeling of pins and needles in my face. Waited a... Read more
Rapid heart rate within 2 minutes of injection, the feeling of pins and needles in my face. Waited at site for 30 minutes, sucked on candy and drank water. Laid down in my car. Left after 30 min. Sat up, and it happened again. Every ten minutes my face would be tingly. Bad taste in mouth. Was told by onsite physician, I had a vasovagal response. 2 hours post injection and I feel better.
33 2021-04-12 taste impairment No symptoms or issues with my first Pfizer vaccine. 15 minutes after the 2nd dose of my Pfizer vacci... Read more
No symptoms or issues with my first Pfizer vaccine. 15 minutes after the 2nd dose of my Pfizer vaccine I experienced a metallic taste in my mouth. That lasted for a few hours after the shot. A rash began above my right hip on my abdomen around 3-4 hours after the injection in my upper left arm. It was a small patch of itchy red hives. The rash now is spread from hip to hip and is continuing to grow. It?s on fire like itch and flares up and then calms down a bit on its own. At about 11 hours after the vaccine I came down with a high temp fever at 102.8 that lasted for 14 hours. Tylenol and Advil did little affect. I had body chills, cold sweats, a terrifying headache, severe vomiting multiple times that I?ve pulled my rib muscles or collarbone area and is now painful to breath in. I dry heaved multiple times for over 3 minutes at a time. My joints were sore and I had muscle pain, insomnia but fatigue at the same time. After 14 hours the fever broke along with the chills, joint and muscle pains. My headache remained as well as my abdominal rash, my fatigue and my cold sweats well into the 3rd day. It?s now day 4 and almost all symptoms have resided except my rash, which continues to grow and itch worse, and my headache.
33 2021-04-12 eye movement disorder, eye swelling started with watery diarrhea, followed by typical fatigue low grade fever migraine and muscle aches ... Read more
started with watery diarrhea, followed by typical fatigue low grade fever migraine and muscle aches by 8pm 4/6/21. by 2am 4/7/21 felt my eyes roll back, lost 2ish hours of consciousness, checked temperate and was 103.7. i felt paralyzed by 4ish am. could not move lower half before 7am, regaining weak movement in upper body. by 8am could barely move my lower half, using a cane to get to the restroom a few steps away from bed. arm that was injected, throat, nose, eyes were all swollen. primary doctor and pharmacist both said to go to ER. went there once i was able to secure a ride and childcare. ER doctor requested blood work and covid test. covid test was negative, blood work came back normal. had a bloody nose before i came home. diagnosed there with post vaccination reaction. told to take benadryl and ibuprofen/tylenol. each day i woke after vaccination unable to move my neck (including today). it takes me several hours to be able to move my neck muscles. waking up 4/8/21 my right side was temporarily paralyzed but regained slow achy movement throughout the day. each day after vaccination joint pain somewhere in my body takes place and nerve pain is often associated. 4/10/21-4/13/21 i have experienced sciatic nerve pain down both sides all the way down to my toes. my nose and throat are still swollen. i am still having to take benadryl daily due to throat swelling. my throat and neck itch.
33 2021-04-12 light flashes or floaters in the eye The night of my first shot, I went to bed but woke up at 3am to use the restroom. Upon washing my ha... Read more
The night of my first shot, I went to bed but woke up at 3am to use the restroom. Upon washing my hands, I started seeing stars and completely blacked out. I had chills but was sweating profusely. I thought I could make it back to my bed but apparently lost consciousness and passed out on my way out of the bathroom, fall forward onto my knees and smashing my head on my bedroom floor. My boyfriend woke up from the bang and found me unconscious for ~10 seconds before he got me to come to. I was extremely disoriented once I came to and he was able to get me back into bed. Since that date (4/6/21 3am), I have experienced a headache like never before. 4/7 and 4/11 were the worst headaches I?ve ever had in my life. I was hysterically crying with ice packs on my head in the dark, as light was very bothersome. Taking Tylenol every 4 hrs during daytime while awake barely shook this headache. I had a good day on 4/10, but then had the set back with the worst headache ever on 4/11. I spoke with my doctor?s office on 4/7 and they decided I most likely had a concussion and could recover at home. I called again 4/12 in the AM after having the worst headache of my life on 4/11 and they could not get me in for a visit until 4/13. I just left that appointment and while I passed their ?neuro? physical exam, I am still experiencing these headaches along with dizziness and shortness of breath when doing the smallest task or bending down and getting back up. I?ve requested a CT Scan to ensure there isn?t a brain bleed causing these issues from my fall which occurred due to the dizziness from receiving this Covid vaccine.
33 2021-04-12 ringing in ears I started noticing a ringing in my ears after the vaccination. I believe it first started the next m... Read more
I started noticing a ringing in my ears after the vaccination. I believe it first started the next morning. I mainly notice it at night when I'm wearing ear plugs. It's continued for a week now, so I thought I should report it.
33 2021-04-13 dry mouth, drooling Patient reported episode of increased heart rate, felt like "heart was racing", for about 1 minute f... Read more
Patient reported episode of increased heart rate, felt like "heart was racing", for about 1 minute following dose of vaccination. This resolved, patient noticed she started to have dry mouth, and increased saliva. This was brought to the attention of the nurse during observation period, and patient brought into examination room. Name and DOB confirmed, vitals obtained and within normal limits. Patient given water, declined juice or snacks. Symptoms resolved after about 20-minute observation period, patient requested to leave at this time. She denies any current chest pain, headache, dizziness, extremity weakness, or loss of consciousness.
33 2021-04-13 eye itchiness Very itchy eyes about 7 hours after vaccine along with one hive on face. Resolved within an hour.
33 2021-04-13 mouth tingling, mouth numbness The first 24 hours I had numbness, tingling on lips, arms and feet but they went away without treatm... Read more
The first 24 hours I had numbness, tingling on lips, arms and feet but they went away without treatment. Four days after numbness on lips came back. Day five inflamation on the arm I had the injection and numbness on two hands. I went to the ER and started Ibuprofen for 10 days. Symptoms did not go away and got worse on seven days. Went back to the ER dimer altered but no curds. Follow-up with a primary doctor, prednisone treatment for a week. Appearance of red spots on the skin. Symptoms improving after 7 days but returned when treatment ended. Back with the doctor and second cycle of prednisone. Currently under treatment without numbness but with pain in the entire arm from the injection that prevents me from carrying out my normal life and the points on the skin.
33 2021-04-14 mouth tingling, swollen tongue 20 minutes after receiving the 2nd dose of the Pfizer vaccine patient's face started itching. This w... Read more
20 minutes after receiving the 2nd dose of the Pfizer vaccine patient's face started itching. This was followed by lip tingling. Next the patient reported swelling of her face, tongue, and neck. Patient was taken to the emergency room and treated with IV steroids. Swelling and itching had subsided after being treated in the ER. Patient still reported a sensation as if a feather was rubbing against her face but since subsided a few days after being discharged.
33 2021-04-15 dry mouth A couple days after receiving Dose 1 of the Pfizer vaccine, I have noticed a significantly drier mou... Read more
A couple days after receiving Dose 1 of the Pfizer vaccine, I have noticed a significantly drier mouth/tongue that has lasted a week and continues. While it is not debilitating/posing a major issue, and I cannot be 100% sure the vaccine was the cause, it is a significant difference from anything I have experienced in the past.
33 2021-04-15 taste impairment Metallic taste in mouth began shortly after the second dose and has continued.
33 2021-04-15 lip swelling, mouth swelling A few weeks after my vaccine I had An event of numbness/ swelling in the right side of my lips / mou... Read more
A few weeks after my vaccine I had An event of numbness/ swelling in the right side of my lips / mouth and upper lip area. It was alarming and the only new occurrence medically in my life was getting the vaccine. Was this a delayed reaction to the products in the vaccine? The episode lasted for about 5 hours and was much better after taking Benadryl.
33 2021-04-15 swollen tongue, mouth swelling, lip swelling Patient called to report she is experiencing mouth, tongue, lip and throat swelling. She also has o... Read more
Patient called to report she is experiencing mouth, tongue, lip and throat swelling. She also has overall body tingling. Nurse gave advice to start Benadryl. Husband is with patient and she is aware of when to go to the ED for treatment.
33 2021-04-17 ringing in ears Initial symptoms in first 48 hours post vaccine: feeling of passing out (presyncope) followed by epi... Read more
Initial symptoms in first 48 hours post vaccine: feeling of passing out (presyncope) followed by episodes of dizziness and chills. Exactly one week post vaccine: presyncope followed by severe vertigo, nausea, disequilibrium , shaking, extreme chills, tinnitus, panic, and intense migraine. MD prescribed steroid ear drops and Xanax. Also took ibuprofen Benadryl and Claritin with minimal relief. Symptoms of panic and vertigo have subsided after 4 days with medicine however still experiencing dizziness nausea anxiety tinnitus and migraine. Follow up with MD on 4/19/21. Wish I never got vaccine. No medical history. Young healthy 33 year old female
33 2021-04-18 mouth swelling Rapid heartbeat, shaking, swelling in mouth and throat. Resolved after 15 minutes. EMT assessment s... Read more
Rapid heartbeat, shaking, swelling in mouth and throat. Resolved after 15 minutes. EMT assessment said everything was ok.
33 2021-04-19 deafness, ear discomfort, ear pain, ringing in ears Tinnitus/ear ringing started the day after I got vaccine. I only noticed it a few times in the first... Read more
Tinnitus/ear ringing started the day after I got vaccine. I only noticed it a few times in the first week, wasn?t too worried. Became constant on 4/12. Mostly ringing, some buzzing or chirping, a few times a day it?s pulsing in left ear. Hearing went out in left ear a couple times on 4/18 for a minute. Fluctuates in intensity and ability to ignore it. Usually around a 2-3 out of 10 in volume. Most noticeable with ear plugs and when laying down. Loudest first thing when waking up. Sometimes feel pressure. A little sharp pain at times. Been taking Benadryl or melatonin to help sleep. Doctor said no sign of inflammation or infection. Believes it could be related to vaccine. I've seen there are over 400 reports of this side effect so far. I hope this is being investigated. I never had tinnitus or ear ringing prior to this.
33 2021-04-20 eye bleeding Blood Vessel Burst in left eye; Brain fog; Dizziness; Fatigue; Nausea; Soreness; Headache; This is a... Read more
Blood Vessel Burst in left eye; Brain fog; Dizziness; Fatigue; Nausea; Soreness; Headache; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 33-years -old via an unspecified route of administration, administered in arm left on 05Apr2021 14:45 (Batch/Lot Number: EW0151) as single dose for covid-19 immunisation. Medical history included polycystic ovaries from an unknown date and unknown if ongoing, gallbladder removed on an unspecified date, allergies: Sulfa from an unknown date and unknown if ongoing. Concomitant medications included calcium; colecalciferol (D3); fish oil; bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC); clarithromycin (CLARITIN); all taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced allergies. The patient experienced blood vessel burst in left eye, brain fog, dizziness, fatigue, nausea, soreness and headache on 05Apr2021 17:00. It was unknown if treatment was received for the events. The patient did not recover from the events.
33 2021-04-20 vision blurred blurred vision, lightheaded - resolved
33 2021-04-21 loss of taste VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being ... Read more
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:02/04/21pfizer,Lot#EL9264 2nd dose: 02/25/21Pfizer,Lot# EN6203 Diagnosed covid positive:04/14/21 Exposure:Home Symptoms:HA,loss of taste
33 2021-04-21 taste impairment, taste disorder contacting over uncommon side affect experienced: mouth tasted like i was sucking on a large handfu... Read more
contacting over uncommon side affect experienced: mouth tasted like i was sucking on a large handful of dirty pennies for from time of vaccine 4/18 until 4/20 late in the evening when that taste shifted to like i had bit my lip and it was bleeding a little bit type of metallic no more dirty penny taste but still metallic, and by time i had lunch on 4/21 the taste was gone. want to do due diligence in reporting this bc i know it was an uncommon side affect from what i googled after it didnt go away within a few hours. water seemed to make the metal taste worse could only do flavored water or a fruit juice. As soon as i got done eating the taste would come back. i used Zyrtec and some peptide stuff to help alleviate the symptoms idk if it worked or not but i tok them starting right after the vaccine when we got home right up tto today bc i figured be afe and o an extra day of it....i was recommended to take them both by a nurse at the fairgrounds bc of my tetnus shot reaction when they flagged her over to tell her about it. I did not know about the tummy med prior actually having an anti histamine thing in it so that is def good info to know for the future! i also felt ridiculously tired the day after the shot w/very little energy it felt and had a super sore arm but that seems to be normal from i've heard from everyone i know who got the shot...not one person had a metal tasting mouth like i had; did not know of the metal taste was even a thing until my husband started goolging and saw that it was very uncommon but harmless, just annoying and no one there said what was normal vs abnormal and my husband had this taste as well for a few mins but he his went away by time our wait time was up and after mine didnt go away by time we got home (2 hr drive) we knew that wasnt right........just want to make sure it gets reported bc it may be more common then what google had it seem bc ppl dont want to jump thru hoops to report things. my primary gave me the number of the local health dept to call who in turn directed me to this site. and well frankly your forms for filling this out could be better like no where have you asked what site did i go to for this just my docs office info which frankly will do no good bc they didnt want to deal with this. they also advised me to bring my vaccine card in for photocopies when it is done bc they are unsure when the state will be sending that info to them which should also have been directed better at the vaccine site that that is what we are supposed to be doing granted maybe its discussed at the second shot time not the 1st. i will still be getting the second shot. but am not looking fwd to it. i was over all very please with how fast and efficient and kind everyone was at the site.
33 2021-04-22 taste impairment 13 weeks pregnant. Experienced severe nausea and vomitings with metallic after taste and heartburn.
33 2021-04-22 eye swelling Slight eye swelling, redness in face
33 2021-04-22 lip swelling Patient had reaction after second dose of Pfizer- hives, pruritus, facial swelling, and swelling of ... Read more
Patient had reaction after second dose of Pfizer- hives, pruritus, facial swelling, and swelling of the lips. Benadryl given and Epi given by EMS. Transported to ED and given Decadron in ED. Monitored for several hours and D/C'ed under stable condition.
33 2021-04-23 sensitivity to light The day after my appointment, I woke up with an intense headache. Felt like my entire head was under... Read more
The day after my appointment, I woke up with an intense headache. Felt like my entire head was under pressure, and I was somewhat sensitive to light. I tried to take a nap, but it didn?t make the headache go away. However the pain went away by itself around 11pm. I didn?t take any pain relievers.
33 2021-04-24 swollen tongue throat swelling; uvula swelling; facial swelling; tongue swelling; This is a spontaneous report from... Read more
throat swelling; uvula swelling; facial swelling; tongue swelling; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 08Apr2021 at 10:00 (at the age of 33 years old) (Lot Number: EW0150, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included diabetes, HTN heart failure, migraine, and hypertension (HTN). Concomitant medications included medroxyprogesterone acetate (DEPO PROVERA) taken from 07Apr2021 to an unspecified stop date; omeprazole (PRILOSEC); clarithromycin (CLARITIN); allopurinol (ELAVIL); magnesium; venlafaxine hydrochloride (EFFEXOR); warfarin sodium (COUMADIN); digoxin; metoprolol tartrate (LOPRESSOR); torsemide; acyclovir; aspirin; topiramate (TOPAMAX); insulin aspart (NOVOLOG); and atorvastatin. The patient previously took bactrim and experienced allergies. The patient experienced throat swelling, uvula swelling, facial swelling, and tongue swelling on 08Apr2021 at 10:00 AM. The events resulted in emergency room/department or urgent care visit. The patient received epinephirine, solumedrol, Pepcid, and Benadryl for the events. It was unknown if the patient has COVID prior to vaccination and unknown if the patient was tested for COVID post vaccination. The patient did not have other vaccine in four weeks. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pharyngeal swelling, enlarged uvula, swelling face and swollen tongue cannot be excluded. While a diagnosis was not provided, the clinical picture and treatment received by the patient point to the likelihood of an allergic reaction. The information available in this report is limited. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
33 2021-04-24 visual impairment 11:45am Observation nurse alerted charge nurse patient sitting in observation area not feeling well.... Read more
11:45am Observation nurse alerted charge nurse patient sitting in observation area not feeling well. Patient is primarily , husband and patient are both communicating to charge. Both reports patient is not feeling well and patient is seeing white light. Charge assessed patient. Patient appears flushed. EMS called. Vital signs BP 124/69, HR 46, O2 100%, R 20. Denies food, fluids or medications before Vaccine. Patient then reports feeling better. 11:52 EMS arrived, assessed Patient. Blood glucose 120, BP 105/61, HR 70, O2 100%, R 18. Patent refuses further evaluation at local hospital. Charge nurse witnessed. Fluids given to patient. Patient and husband informed to contact EMS if symptoms worsen. Patient and husband voiced understanding. Patient and husband left site
33 2021-04-24 visual impairment I woke up the next morning feeling achy in all my muscles and joints, dizzy and feverish. While sitt... Read more
I woke up the next morning feeling achy in all my muscles and joints, dizzy and feverish. While sitting at the table, I abruptly felt tingling and numbness in my hands, similar to when they fall asleep, but much stronger. It was very difficult to move them. My vision dimmed. The vision dimness and trouble with my hands lasted for a few minutes and started to dissipate after I stood up and walked a little. The aches, fever, and dizziness persisted for the rest of the day.
33 2021-04-25 mouth tingling ANXIOUS, RACING HR, TINGLING LIPS, SORENESS LEFT ARM. PT HAS HX ANXIETY AND PANIC ATTACK. HEALTH PER... Read more
ANXIOUS, RACING HR, TINGLING LIPS, SORENESS LEFT ARM. PT HAS HX ANXIETY AND PANIC ATTACK. HEALTH PERSONNEL AT SITE. PT WAS OFFERED HYDRATION AND FOOD, NOW C/O MUSCLE TWITCHING ON LEGS ARMS AND JAW. STATED HAD THIS SYMTOMS BEFORE, VSS, SYMPTOMS IMPROVED, REFUSED TRANSPORT, WILL GO TO HOSPITAL IF WORSEN.
33 2021-04-26 hearing loss, ringing in ears, ear discomfort Woke up on the morning of the 21st and my left ear felt clogged. Whenever I would speak or hear a lo... Read more
Woke up on the morning of the 21st and my left ear felt clogged. Whenever I would speak or hear a loud noise, it would feel like someone running a metal spoon on a large metal bowl, resonating inside of my ear. This persisted for several days and I would also have occasional tinnitus that would come and go, so I went to the walk-in center on Saturday. The doctor prescribed prednisone and I took it for 1 day but had extremely adverse reaction so I stopped taking it. The loud resonance in my ear seems to have gone down somewhat over the last two days, but now I have tinnitus in both ears that is most prominent in the silence and is mostly steady now. I have been trying to get an ENT referral from the walk-in center for two days now and they keep saying they will get back to me and I keep calling but no one has gotten back to me with a referral. I have been taking lots of immune-boosting foods, supplements, and anti-inflammatory fruits and vegetables just trying to keep my immune system healthy. I am still recovering from the adverse effects from the prednisone.
33 2021-04-26 mouth numbness, lip swelling numbness in mouth; cold sore; lip swelling and facial itching; lip swelling and facial itching; This... Read more
numbness in mouth; cold sore; lip swelling and facial itching; lip swelling and facial itching; This is a spontaneous report received from two contactable nurses (one is patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EZ9261, Expiration Date: May2021), via an unspecified route of administration on left arm on 12Feb2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included cold sore (history of cold sores for 15 years, takes Valtrex to treat it). Concomitant medication included valaciclovir hydrochloride (VALTREX) taken for cold sore. The patient stated that she received the COVID-19 vaccine last Friday, 12Feb2021, states she was eligible at her employer, it was done at (pharmacy name). States since Sunday, 14Feb2021, she has experienced lower lip swelling and facial itching. States she also developed a cold sore on 15Feb2021 but has a history of cold sores for 15 years, takes Valtrex to treat it. States she also has numbness inside of her mouth on 18Feb2021. States she has no clue if it has anything to do with the vaccine. The outcome of the events was reported as not recovered.
33 2021-04-26 lip swelling, swelling of eyelid Extreme fatigue a couple hours after receive, maybe around 2p. Took a nap for maybe 2 hours, face s... Read more
Extreme fatigue a couple hours after receive, maybe around 2p. Took a nap for maybe 2 hours, face started to feel itchy and tight. Around 8pm I look in the mirror and I notice my face looked a little puffy, and tiny bumps around my nose and mouth. The next morning, around 5am, my eyelids and lips were noticeable swollen and the hives (tiny bumps) were covering my face, it was itchy mostly around my nose and mouth. I took Zyrtec every day for three days. The swelling went down after the second day, the hives (tiny bumps) cleared up around day three, my skin was completely normal after about a week. On April 13, I started to feel fatigued ( same way I did after I got the vaccine on the 3rd), the next morning my eyelid and lips were swollen and hives and itchness returned. I contacted doctor and he suggested taking Allegra 24 during the day and Benadryl at night ) if I?m itchy. He almost prescribed prednisone for 3 days,but only take if my face was still swelling the next day. On the 14th, my face was still swelling so I started the prednisone. It took about 4 days for my face to clear up completely
33 2021-04-26 oral mucosal blistering Extreme abdominal cramping, akin to contractions during labor (experienced this at first shot as wel... Read more
Extreme abdominal cramping, akin to contractions during labor (experienced this at first shot as well). Blisters in mouth. Full body weakness, barely able to move.
33 2021-04-27 eye swelling loss of consciousness plus all the normal symptoms; paralysis/partial paralysis; Fever of 103.7; dia... Read more
loss of consciousness plus all the normal symptoms; paralysis/partial paralysis; Fever of 103.7; diarrhea; nausea; dizzy; joint pain; migraine; throat swelling; nose swelling; eyes swelling; This is a spontaneous report received a contactable consumer, the patient. A 33-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot ER8729 and expiry information not reported) in the right arm via unspecified route on 06Apr2021 at 09:45 (at 33 years-old) for COVID-19 immunisation. Relevant medical history included asthma, allergies, penicillin and adhesive tape allergies, and high blood pressure. Concomitant medications included lisinopril. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot ER7531) in the right arm on 16Mar2021 at 09:45 (at 32-years-old). The patient previously received treatment for an unspecified indication with hydrocodone bitartrate/paracetamol (NORCO) and experienced an allergy. The denied being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at time of vaccination, and the patient denied receiving any other vaccine within four weeks of this vaccine. On 06Apr2021 at 20:00 the patient experienced fever of 103.7, diarrhea, nausea, dizzy, paralysis, partial paralysis, joint pain, migraine, throat swelling, nose swelling, eyes swelling, loss of consciousness plus all the normal symptoms. The patient reported as a result of the events the patient sought care with a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was tested for COVID-19 since the vaccine with nasal swab test on 07Apr2021 and was negative. Treatment for the events received in the emergency room (ER) included diphenhydramine HCl (BENADRYL), ibuprofen, and acetaminophen (TYLENOL). The outcome of the events, fever of 103.7, diarrhea, nausea, dizzy, paralysis, partial paralysis, joint pain, migraine, throat swelling, nose swelling, eyes swelling, loss of consciousness plus all the normal symptoms, was not recovered.
33 2021-04-27 lip swelling I started getting hives on the left side of my neck at 9A on Monday, 4/26/2021. The hives spread to ... Read more
I started getting hives on the left side of my neck at 9A on Monday, 4/26/2021. The hives spread to the back of my neck and torso by 12p. By 5:30p the hives spread to my hips and upper thighs. I woke up the following morning, Tuesday, 4/27/2021 with pain in my chest when swallowing saliva and started getting more hives. By 8a my upper left lip started swelling and I decided to go to the hospital.
33 2021-04-27 sensitivity to light Since the day after 2nd dose, absolutely horrible migraines constantly. Present from the minute waki... Read more
Since the day after 2nd dose, absolutely horrible migraines constantly. Present from the minute waking up to minute going to sleep. Had NEVER had headaches in the past. Seeked medical attention from my doctor. Sent for a contrast brain MRI. Showed a small cyst in sinuses. Tried amoxicillin. Didn?t help at all. Have been taking Tylenol/excedrin for a month now. In intense discomfort everyday. I need some guidance as to what to do and how medical attention will be covered. I am extremely sensitive to light now since the 2nd dose. Again, I experienced no headaches before this 2nd dose
33 2021-04-27 ringing in ears Shingles outbreak about a week after 1st dose. Ringing in ear started same day as 2nd dose, still ri... Read more
Shingles outbreak about a week after 1st dose. Ringing in ear started same day as 2nd dose, still ringing a week later.
33 2021-04-27 toothache About 7 hours after my vaccine, I started experiencing chills and body aches. 9 hours after the vacc... Read more
About 7 hours after my vaccine, I started experiencing chills and body aches. 9 hours after the vaccine, I felt as if I?d taken cold medicine. I was slow to react, felt ?foggy?, I had trouble recalling words and the names of household objects I was staring at, my movements weren?t coordinated and I dropped a few things. During the night, I was tired but had trouble sleeping. The body aches worsened and really concentrated in my joints, especially my spine. I stayed either in bed or on the couch the whole day following my vaccine but my heart rate (as read by my smart watch) would go from the 70?s to as high as 129 just from sitting up higher in bed. My normal resting heart rate is in the upper 50?s/lower 60?s and I don?t see 120+ unless I?m working out for at least 20 minutes. I didn?t take Tylenol or Motrin until 7 PM on April 19th (I took 800mg of Motrin) about 34 hours after my vaccine. I had a low grade fever and my head ached so bad all my teeth were throbbing before I took the Motrin. I started to feel better within a hour of taking Motrin and was fine from then on. I only took Motrin the one time.
33 2021-04-28 loss of taste Fainting; Swelling of arm; no taste; headache; This is a spontaneous report from a contactable consu... Read more
Fainting; Swelling of arm; no taste; headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration, administered in the left arm on 13Apr2021 at 13:30 as a single dose for COVID-19 immunization. Medical history included narcolepsy from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. The patient's concomitant medications were not reported. The patient previously took Cymbalta and experienced allergies. The patient was not tested for COVID post vaccination. On 13Apr2021 at 05:30 PM, the patient experienced fainting, swelling of arm, no taste and headache. The patient did not receive treatment for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
33 2021-04-28 ringing in ears 4 days after vaccine I woke up with vertigo, feeling off balance, full head. Noticed tinnitus in bot... Read more
4 days after vaccine I woke up with vertigo, feeling off balance, full head. Noticed tinnitus in both ears along with tingling in face. Tinnitus remains constant 16 days after onset with no change.
33 2021-04-29 ringing in ears Within minutes of being injected with my second dose I experienced ear ringing to what I know to be ... Read more
Within minutes of being injected with my second dose I experienced ear ringing to what I know to be called Tinnitus. It hasn't stoped.
33 2021-04-30 eye swelling, eye pain hangover like headache; hangover like headache; right eye was swollen and painful; right eye was swo... Read more
hangover like headache; hangover like headache; right eye was swollen and painful; right eye was swollen and painful; This is a spontaneous report from a contactable physician, reporting for herself. A 33-year-old non-pregnant female patient received the second dose of the bnt162b2 (BNT162B2), via an unspecified route on 27Mar2021 at a single dose of administration for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There were no allergies to medications, food, or other products. The patient previously received the first dose of the bnt162b2 on 06Mar2021 at a single dose for covid-19 immunisation. No other vaccines administered within 4 weeks prior to the immunization. In Mar2021 (reported as 01Mar2021), the patient experienced hangover like headache for one day and morning right eye was swollen and painful, which required physician office visit. The events were further described as: hangover like headache for one day, resolved by next day, Monday morning right eye was swollen and painful. Therapeutic measures were taken in response to the events. There was no covid-19 prior to or post vaccination. The clinical outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
33 2021-04-30 burning mouth syndrome, pain in jaw my face was paralyzed slightly due to Bell's palsy; my tongue had a sore; I got pain in my jaw and p... Read more
my face was paralyzed slightly due to Bell's palsy; my tongue had a sore; I got pain in my jaw and pain in my left side of my neck for about 3days; I got pain in my jaw and pain in my left side of my neck for about 3days; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7534) via an unspecified route of administration, administered on the left arm on 17Mar2021 13:00 at a single dose for COVID-19 immunisation. Medical history included Bell's palsy (prior case, 9 1/2 years ago). The patient's concomitant medications were not reported. On 21Mar2021 12:00 PM, within the 3rd day her tongue had a sore. It went away and she got pain in her jaw and pain in the left side of her neck for about 3days. Then, her face was paralyzed slightly due to Bell's palsy. It went away within a week and a half. Treatment was received for the events which included medication to help with Bell's palsy. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The facility where the vaccine was administered was in a Public Health Department. No known allergies. Outcome of the events was recovered on an unspecified date in 2021.
33 2021-05-01 ringing in ears, deafness unilateral, ear swelling Extreme Pulsatile Tinnitus started in the right ear after the vaccine. Then loss of equilibrium and ... Read more
Extreme Pulsatile Tinnitus started in the right ear after the vaccine. Then loss of equilibrium and vomiting that led to overnight hospitalization. Hearing loss in right Ear and vertigo still present.
33 2021-05-02 ear discomfort, ringing in ears, mouth tingling Sudden severe onset vertigo, completely debilitating and lasting for approximately 5 hours. Subside... Read more
Sudden severe onset vertigo, completely debilitating and lasting for approximately 5 hours. Subsided same evening. Still left with lingering dizziness, bouts of pressure in ears and tongue tingling, and marked increase in consistent tinnitus. I'm on a daily regimen now of ibuprofen and antihistamines, to keep the symptoms manageable, they return when I do not take it. All of these symptoms are new, experienced after the vaccine (aside from the tinnitus).
33 2021-05-03 mouth itchiness, mouth ulceration, swollen lips Facial itching within first 45 minutes of injection. Within 3 hours small blisters formed on right u... Read more
Facial itching within first 45 minutes of injection. Within 3 hours small blisters formed on right upper lip and left lower lip. Oral itching progressed. Hives formed around mouth, eyes, jaw, and forehead. Itching and hives continued despite benadryl 25-50mg PO daily and covering face in hydrocortisone cream. Oral blisters worsened and covered entire lips. Oral ulcers started inside mouth as well on day 2 post injection. The itching, blisters, and ulcers continued for 6 days without any improvement. PCP seen and steroid pack prescribed. Resolved issues after completion of day 4 of steroids. Entire pack completed without recurrence of hives.
33 2021-05-03 smell distorsion, taste disorder, taste impairment After the vaccination, as the days passed, the food began to smell strange. It has already reached t... Read more
After the vaccination, as the days passed, the food began to smell strange. It has already reached the point that I feel that smell in the taste. Food and liquids taste like metal to me. Some foods like bread I can't tolerate.
33 2021-05-03 visual impairment, eye floaters After first shot had a very severe dizzy spell that night. Then continued to have lower-grade vertig... Read more
After first shot had a very severe dizzy spell that night. Then continued to have lower-grade vertigo (occasional major dizzy spells) and vision problems for about three weeks afterwards. Was seen by eye doctor and eyes looked normal. Got second dose, and it seemed to improve for a couple days then came back. After a few weeks of continued vertigo and vision problems (mostly depth perception and suddenly became extremely aware of pre-existing eye floaters because of the disorientation) went to an ENT and they were not able to find anything visibly wrong related to vaccine. Went on Ativan and symptoms have improved somewhat on it, but am very scared of them coming back when i go off of it. Seems to be improving very very slowly. This has been almost 2 months of symptoms now. Made it very hard to work or drive.
33 2021-05-04 loss of taste, loss of smell New loss of taste or smell Congestion or running nose
33 2021-05-04 ear discomfort, ringing in ears Presyncope severe disequilibrium; Presyncope severe disequilibrium; vertigo; nausea; migraine (head ... Read more
Presyncope severe disequilibrium; Presyncope severe disequilibrium; vertigo; nausea; migraine (head and ear pressure); migraine (head and ear pressure); migraine (head and ear pressure); tinnitus; tremors; Vestibular disturbances; This is a spontaneous report from a non-contactable Nurse (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 07Apr2021 10:00 AM at single dose for COVID-19 immunisation in Pharmacy or Drug Store. Medical history was none. If No other vaccine in four weeks. No Known allergies. No other medications in two weeks. Patient was not pregnant. Patient experienced Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors. Vestibular disturbances lasting for Weeks. Adverse event start date was 14Apr2021 03:15 PM. event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No covid prior vaccination. no covid tested post vaccination. Treatment received for the events with Steroids, Xanax, Benadryl, ibuprofen. Patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors and Vestibular disturbances due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-05-05 ringing in ears Tinitus, Vertigo, Fatigue (headache sometimes of the day). And all these have been last for 3 weeks ... Read more
Tinitus, Vertigo, Fatigue (headache sometimes of the day). And all these have been last for 3 weeks now (they started 1 week after the shot) I went to earing doctor, they said nothing wrong with my ears
33 2021-05-06 ear pain Dizzy and lightheaded 40 min after injection. Within 24 hours severe chills and fatigue, light heade... Read more
Dizzy and lightheaded 40 min after injection. Within 24 hours severe chills and fatigue, light headed, headaches, irregular heartbeat, ears ache, chest pain and shortness of breath. 8 days later was onset in severe vertigo. 2 days after second dose was moderate vertigo and mild fever.
33 2021-05-06 eye pain Left arm numbness. Iritis. Eye inflammation with severe eye pain and inflammation.
33 2021-05-06 lip swelling, mouth tingling On May 6th, 2 days after the second dose of the Pfizer vaccine, which was on May 4th, I started expe... Read more
On May 6th, 2 days after the second dose of the Pfizer vaccine, which was on May 4th, I started experiencing mild tightness in the throat and tingling of the mouth starting around 11 PM EST. The next morning, on May 7th, around 6 AM EST, I started experiencing itching all over my body, arms legs and face. Within 30 minutes my body was covered in hives and my bottom lip was very visibly swollen. Since doctor's office was not open, I decided to take 1 Cetirizine Hydrochloride tablet 10mg and 1 Diphenhydramine HCI 25 mg Antihistamine at the same time. Lip swelling went down and hives started to disappear within 90 minutes. Itching also stopped.
33 2021-05-06 mouth pain, mouth tingling Pain and tingling in mouth. Pain in arm for days. Weakness for 13 days. Changes to menstrual cycle. ... Read more
Pain and tingling in mouth. Pain in arm for days. Weakness for 13 days. Changes to menstrual cycle. Headache. Depression/irritability dizziness/lightheaded
33 2021-05-06 mouth tingling Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck... Read more
Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head; new and sudden onset of popping joints; Temporary paralysis and numbness upon waking up in the morning; Temporary paralysis and numbness upon waking up in the morning; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands; Heart rate spike to 180; dizziness; sweating; sudden aching and weakness in both hands, progressed upwards through legs, hips, arms, back, neck and head; sudden aching and weakness in both hands; Severe head and facial pain; Severe head and facial pain; Pain, tingling, burning, and weakness in extremities and limbs; Pain, tingling, burning, and weakness in extremities and limbs; Vibrations/tremor-like sensation in upper back; Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EN6200, first dose) solution for injection intramuscular in the left arm on 27Feb2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. Medical history included SVT (supraventricular tachycardia). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Feb2021, the patient experienced heart rate spike to 180 within first 2-3 minutes of vaccine with dizziness, sweating and sudden aching and weakness in both hands; severe head and facial pain, pain, tingling, burning, and weakness in extremities and limbs; vibrations/tremor-like sensation in upper back; tingling tongue; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands, sent to ER for monitoring. Continued heart rate spikes for approx. 7 days afterwards. Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head over 1 week period. On 09Mar2021, 10 days after vaccination; two more ER visits. Severe head and facial pain. Pain, tingling, burning, and weakness in extremities and limbs. Vibrations/tremor-like sensation in upper back. Tingling tongue, new and sudden onset of popping joints, temporary paralysis, and numbness upon waking up in the morning. Multiple lab work orders, X-rays, MRIs - all ruled out other causes/conditions in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, with disability or permanent damage due severity of symptoms required 4 weeks of medical leave from work. Treatment for the events included medication and physical therapy. The outcome of the events was not recovered. Post vaccination, a Nasal Swab, Covid test result was negative in Mar2021.
33 2021-05-06 lockjaw Neurological symptoms, specifically I have begun moving my mouth when I think (muttering) and I am u... Read more
Neurological symptoms, specifically I have begun moving my mouth when I think (muttering) and I am unaware I am doing it and unable to control it. Onset was sudden and I have never experienced this before.
33 2021-05-07 loss of taste, loss of smell Cough Shortness of Breath Difficulty breathing Fatigue Muscle or body aches New loss of taste o... Read more
Cough Shortness of Breath Difficulty breathing Fatigue Muscle or body aches New loss of taste or smell Sore throat Congestion or running nose Diarrhea
33 2021-05-07 drooping eyelid Right eye drooping about 12 hours after second pfeizer vaccine. Later, noticed that the right pupil ... Read more
Right eye drooping about 12 hours after second pfeizer vaccine. Later, noticed that the right pupil is larger than the other.
33 2021-05-07 teeth hypersensitivity Teeth sensitivity, front teeth. It feels like a similiar sensation to using strong Crest Whitestrips... Read more
Teeth sensitivity, front teeth. It feels like a similiar sensation to using strong Crest Whitestrips daily. Teeth are sensitive to inhaling via mouth and sensitive to drinking room temperature water of about 75 degrees.
33 2021-05-07 lip swelling Sensation of swelling in her lips 20 mins after vaccine given that continued to persist
33 2021-05-09 eye pain 12 hours after: high fever (103-104), sweats, sore eyes, fatigue. High fever (over 102-104) lasted f... Read more
12 hours after: high fever (103-104), sweats, sore eyes, fatigue. High fever (over 102-104) lasted for >24h. 3 days after vaccine, I still have a fever (100) and still have a headache
33 2021-05-09 vision blurred On the day of the vaccine (5/7) I just felt tired and pain on my arm. The next day (5/8) I had a po... Read more
On the day of the vaccine (5/7) I just felt tired and pain on my arm. The next day (5/8) I had a pounding headache that wouldn't go away. Pain in all my joints. Pain in my lower back. Neck pain. Low fever. Exhaustion. Felt extremely cold. Pain in the shot area. I took an Aleve and rested all day, symptoms were better but didn't completely go away. 5/9 Strong lower back pain. Headache (mild) . Felt angry and exhausted all day as if I had PMS, but it can't be PMS since I had period the week prior to the vaccine. 5/10 developed a big red bump with hives on the vaccine area and also pain. Been having headaches on and off all day. Little blurriness of vision, feeling a little bit dizzy. Strong lower back pain. Took aleve and put voltaren on back. Feeling a little bit of heart palpitations every now and then. Will take benadryl to see if it helps with the bump/hives.
33 2021-05-11 eye strain I?ve been having numbness and tingling throughout my body. It jumps around from my arms/fingers, leg... Read more
I?ve been having numbness and tingling throughout my body. It jumps around from my arms/fingers, legs:toes, and most recently face. It varies in severity from mild tingles to pins and needles. Some lightheadedness and muscle weakness. I saw the doctor on Monday and he did a physical exam for reflexes and muscle strength etc. he ordered labs for me to rule out anything medically causing the numbness. A day by day symptom list is listed below. Tomorrow will be one week with numbness. I have emailed the doctor again tonight as the blood work results have begun to come back with nothing abnormal, I believe the next step will be to see the neurologist. Onset - 6th at 1 pm. Numbness in right arm and lightheaded. Right eye felt heavy. Friday - 7th - felt some in both arms and legs. Mild tingling. Noticed legs felt tingly. Saturday - 8th - during day - Numbness in legs during car ride. Night at bedtime - very anxious. Moved to left side based on how she was leaning in bed. Sunday - 9th - all on left side. Monday - 10th - saw dr. Isolated to left arm. Lightheaded in the morning. Legs were bad at gymnastics after sitting on bleachers. Tuesday- 11th - left side worse, not as isolated. Left side of face jaw line to mouth and in neck. Around 4:15 pm. Wednesday - Tiny bit in face (7-?). Legs and arms. Primarily left arm.
33 2021-05-11 mouth numbness, eye twitching 1st Dose of Pfizer: 3/25 - 3.25 starting experiencing dizziness on the drive back and went to sleep ... Read more
1st Dose of Pfizer: 3/25 - 3.25 starting experiencing dizziness on the drive back and went to sleep - 3.26 start urinating blood - 3.27 went to Urgent Care, did urine analysis, and got antibiotics, took for 7 days, finished all antibiotics on 4.2 - 4.2 rectal pain and went to the rectal doctor, 7prescribed antibiotics, took for 10 days - 4.10 tongue numbness started - 4.14 right eye start twitching 2nd Dose of Pfizer: 4/15 - 4/15 after shot, start to experiencing severe facial paralysis - 4/15 went to ER on that evening, ER doctor said is bell's palsy, total right facial paralysis - 4/16 lower body experiencing pain and weakness, facial paralysis 2nd day - 4/18 started acupuncture, headache and temple pain, facial paralysis 4th day - 4/19 went to see the rectal doctor again, rectal severe pain, facial paralysis 5th day - 4/20 went to see neurologist, re-confirmed Bell's Palsy, issued MRI for brain - 4/21 continued rectal pain -4/23 severe rectal pain (level 8/10), went to ER, had Morphine, had CT scan -4/26 see rectal doctor, prescribed pain medicine, but nothing can be done, told to wait it grow bigger -4/30 MRI for the brain - 5/3 Saw another neurologist, -5/10 saw the rectal doc, did procedure in office to cut open a hole in buttock -5/11 start shortness of breath -5/12 low blood pressure, high pulse (116), rectal pain, facial paralysis continue
33 2021-05-11 lip swelling lips felt swollen, throat tightness. Evaluated by EMS-Refusal to transport.
33 2021-05-12 taste impairment, smell distorsion I have a horrible taste of metal in my mouth. I smell metal.
33 2021-05-13 loss of taste, loss of smell The day after I got my 2nd covid vaccine, I lost my sense of taste and smell. I did have covid in Ja... Read more
The day after I got my 2nd covid vaccine, I lost my sense of taste and smell. I did have covid in January and lost my sense of taste and smell, but got it back once I tested negative. But since the vaccine, I have not gotten my smell or taste back.
33 2021-05-14 mouth tingling angioedema; hives; in lips tingling at times; itching; rash; This is a spontaneous report from a non... Read more
angioedema; hives; in lips tingling at times; itching; rash; This is a spontaneous report from a non-contactable other hcp. A 33-year-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) dose 1 via an unspecified route of administration on Dec2020 (at the age of 32-year-old) as single, and dose 2 via an unspecified route of administration on Jan2021 as single for covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. On 2021, Reporter's daughter had the first Pfizer vaccine in DEC 2020. The second in JAN 2021, 10 days after she broke out in hives and had some angioedema, in lips tingling at times, no throat closures. Eye angioedema was the first sign, around the eyes, that went away and was off and on. On day 10 she woke up with this and has had it ever since. angioedema of the lips on and off. Since Jan 21 she's been headed to toe with hives they never go away, some days her legs are just covered. On 2021, the reporter sated that, 5 days after 2nd vaccine angioedema around both eyes and that was gone now, she's been to dermatologist, immunologist and primary care physician and they've tried, prednisone, IV Benadryl, Zyrtec, Allegra, also done oatmeal baths for itching, dermatologist wanted to put her on cyclosporine, she didn't want to go on it because it's a strong antibiotic. They also gave her pepcid. Reporter asked to have anyone else had anything like this and why it is lasting so long. Reporter stated that everyone was saying, it's an immune response, and give it time and see if it goes away. her daughter woke up in a huge snowstorm the first time she had the angioedema with Mouth, she went to the Emergency Room, they gave her IV Benadryl, kept her there for a little while, sent her home on prednisone pack, not tapered, just 5 days of high dose prednisone. When the prednisone was finished, it came back with a vengeance. Then she went to her Primary Care Physician to see if she had any suggestions. They wanted her to go back on the Prednisone but on a tapered dose, but, she didn't' want to take it because she was afraid it would come back worse than ever. It never got better, not even on the high dose prednisone. Other than put her on the prednisone, there wasn't really anything more. 4 Months later it hasn't settled down. Reporter asked her daughter to come to where she lives and see Dermatologist, and he ordered a bunch of labs and got it back and it all looked fine. He wanted to start her on cyclosporine, she wanted to wait, didn't want to take it. Reporter stated, "It wipes the immune system out. They give it to transplant patients. they all say It's an immune response, it should settle down. Her daughter has been trying to change her diet, eating things low in histamines, cut out tomatoes, cut out cheeses, everything high in histamines, it doesn't make a difference. Reporter stated, One day they are not quite so bad and then she wake's up and she was covered. Her daughter can't walk, or swim cause hot and cold makes her break out, or makes it worse, because it never goes away. The following adverse reactions have been identified during post authorization use of Pfizer BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema). The outcome of the events was reported as unknown. No follow up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
33 2021-05-16 loss of taste, loss of smell Patient lost pregnancy after her first dose of vaccine Patient has had increase in disruption of tas... Read more
Patient lost pregnancy after her first dose of vaccine Patient has had increase in disruption of taste and smell (first starting after her prior COVID infection) since vaccine series.
33 2021-05-16 mouth numbness, mouth tingling Numbness and tingling in face, tongue, and hands. Fatigue. Pre-syncope.
33 2021-05-17 loss of smell, loss of taste Pt tested positive for COVID 5/17/21. Completed COVID vaccine series 1/18/21. Sore throat/headache o... Read more
Pt tested positive for COVID 5/17/21. Completed COVID vaccine series 1/18/21. Sore throat/headache onset 5/12. Reports negative PCR since then, but we have no documentation of this. Loss of taste/smell 5/17 followed by positive PCR. Multiple positive household members.
33 2021-05-17 dry throat, mouth itchiness First client complained of a dry throat. Water given to drink. Client continued to complain of itc... Read more
First client complained of a dry throat. Water given to drink. Client continued to complain of itchy palate, felt like throat was swelling, and throat burning. Benadryl 50mg IM given. Itchy palate resolved, but client continued to complain of throat burning. Client with no distress, no trouble breathing. Client refused EMS transport, but did agree to go to ER with husband.
33 2021-05-17 taste impairment Immediate metallic taste in mouth. Tightness in throat and back of neck that started 5 minutes after... Read more
Immediate metallic taste in mouth. Tightness in throat and back of neck that started 5 minutes after shot. Has persisted for 1 week and still going. Symptoms come in waves but not has peaked higher than initial reaction.
33 2021-05-17 ringing in ears 6 hours post vaccine, headache, chills, fever, body ache, vomiting. alleviated after 48 hours 3/15/2... Read more
6 hours post vaccine, headache, chills, fever, body ache, vomiting. alleviated after 48 hours 3/15/21: tinnitus in both ears. not resolved. dull pain in abdominal area, not resolved
33 2021-05-17 vision blurred I immediately started menstruation 5 days earlier than expected less than 1 hour after receiving the... Read more
I immediately started menstruation 5 days earlier than expected less than 1 hour after receiving the 2nd dose of this vaccine. Next I noticed my vision was slightly blurry and I was becoming lethargic. Within 12 hours I had a low grade fever, heart palpitations, and severe night sweats. By 24 hours I felt out of breath if I walked more than 10 feet away and I got extremely dizzy and felt faint if I walked too far. My period lasted 2 days longer than it should have and was heavier than normal. It is now 12 days later and I still feel fatigued, anxious, dizzy, and my hormones feel off. I definitely do not feel right. I get nauseous from the dizziness even though I have been drinking a gallon of water a day and not exercising. I am a very active person and I have been forced to be extremely inactive to keep all of these symptoms at bay.
33 2021-05-18 eye swelling, ear pain Eye swollen; nauseated; Fever; chills; coughing; Body ache; Muscle ache; Tired; Ear ache; This is a ... Read more
Eye swollen; nauseated; Fever; chills; coughing; Body ache; Muscle ache; Tired; Ear ache; This is a spontaneous report was received from a contactable other hcp. A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via intramuscular route of administration, administered in arm left on 27Jan2021 12:00 as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient had history of promethazine allergy. The patient was not pregnant at the time of vaccination. The patient did not take any other vaccine in four weeks and did not take other medications in two weeks. On 27Jan2021 at 20:15, the patient was feeling nauseated, fever, chills, coughing, body ache, muscle ache, tired, earache, eye swollen. The patient did not take any treatment. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via intramuscular route of administration, administered in arm left on 06Jan2021 12:00 as single dose for covid-19 immunisation. The patient had no covid prior vaccination. On 28Jan2021, (post vaccination), the patient underwent lab tests and procedures which included covid-19 and the results were pending. The outcome of the events was recovering. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
33 2021-05-18 lip swelling Patient had history of allergic reaction to percocet per pt. Had EpiPen in her purse. Asked pt to r... Read more
Patient had history of allergic reaction to percocet per pt. Had EpiPen in her purse. Asked pt to remain after shot, She become "warm" and anxious, described feeling as having too much caffeine. Also said she was light headed, she remained seated for a while longer with a cold compress on her forehead. She later reported feeling her lips tighten and arms and feet tingling. Asked if she was ok to take benadryl, she was, so we gave 10cc of benadryl liquid and asked her to lay day behind the cash wrap area. We elevated her feet and seemed to make her feel better. We called 911 and EMS arrived. Patient was still alert and conscious.
33 2021-05-18 mouth tingling, mouth numbness increased blood pressure, lips numb/tingling, and short of breath
33 2021-05-19 lip swelling Pfizer-BioNTech Covid-19 Vaccine EUA Symptoms started at about 12:20 p.m. I experienced tightening ... Read more
Pfizer-BioNTech Covid-19 Vaccine EUA Symptoms started at about 12:20 p.m. I experienced tightening in my throat and lip swelling. I took Benadryl. The symptoms returned later in the day. I went to urgent care and was directed to the ER. I received IV Benadryl, Pepcid, and fluids.
33 2021-05-19 visual impairment Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mil... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: pt breastfeeding. nervous. pt felt better after water and waited for 20 more min
33 2021-05-20 ear discomfort, ear pain Started feeling warm at the injection site within 2 hours of the vaccine injection. Warm and numb fe... Read more
Started feeling warm at the injection site within 2 hours of the vaccine injection. Warm and numb feeling spreading into my left shoulder bone, left cheek, jaw, up to my eye brow. Feeling as if left side of my face is swollen but it?s not swollen when looking in the mirror. Pressure in left ear - as if I was diving and got water in my ear, or as if I just got off the airplane with altitude changes. On and off ear ache still present 10 days after injection, in both ears......
33 2021-05-20 ear pain May 8: In the mid-afternoon I developed a blister on my right elbow at an outdoor gathering. It did ... Read more
May 8: In the mid-afternoon I developed a blister on my right elbow at an outdoor gathering. It did not hurt. I thought I had perhaps been bitten by a bug. Once the blister burst it was moderately painful, and it has been slow to heal (I still have the scab). I don't think it's related (wrong side of the body, appeared before the back pain, etc.) but only mention it because it was similar in appearance to the first large blister on my left breast (except smaller, maybe 1/3 the size), and that is why I initially brushed off the blistering. May 12: I began having intermittent back pain between my left shoulder blade and my spine. I had fallen off our hammock the day before and attributed the back pain to that. May 13: I woke up with a large (1.5") blister on the left (outer) side of my left breast. I often sleep with a heating pad, and thought that I must have burned myself. However, I found it strange that it did not hurt at all. I thought perhaps I had touched a poisonous plant while gardening, and had then touched my breast putting my phone in my bra, or something. I even thought it was maybe a weird spider bite. None of these seemed to fit because the area didn't hurt. May 14: the back pain continued intermittently and I took naproxen sodium to control the pain. The blister remained painless. May 15: It was hot that day (80 degrees) and we went to a local garden and did a lot of walking around. When I got home that night I had a slightly irritated patch of skin on my left side - right at the level of my bra strap and I assumed I had heat rash. The bumps were surprisingly tender, but not connected (stand alone little dots). My back pain had worsened - it was hard to pick up and hold my children, it was tender from the walk, and I kept on a strict schedule of naproxen sodium every 8 hours to try to control the pain. May 16: It was hot again and we went to a couple more local gardens and walked around. My back pain was pretty bad, but manageable when I wasn't carrying the kids. At the end of the day when I got home I saw that the "heat rash" had spread in a line under my left breast. It was now very tender to the touch, but felt fine if you left it alone. I was concerned that I had some sort of breast inflammation, and again, did not connect it to the back pain. May 17: My back pain was unmanageable, and I had to take several breaks from work to lie down. In the evening I discovered that the small dots on my left side were not pimples/ irritated skin, but rather tiny individual blisters. After looking into it more, I thought that I possibly had shingles since I had had chickenpox as a kid. May 18: My sleep was interrupted by the bad back pain, and I woke up several times. When I woke up the rash had spread to my sternum, and around my side onto my back. It was incredibly painful to the touch, and instead of being standalone dots there was now red inflammation connecting the blisters. My back pain was incredibly bad. I called and tried to get an appointment to see my doctor, but could not get scheduled until the morning of May 19. May 19: Did not sleep well due to pain. Doctor performed a visual exam of the inflammation and listened to the symptoms and diagnosed me with shingles with complications (the nerve pain). I had two pin prick red dots on my left wrist, and one itchy red bump on my left leg and I was concerned that it was spreading to other areas of my body. Prescribed the retroviral valacyclovir 1 g three times/ day for 7 days to try to reduce the length and severity of the illness, but advised that I had started treatment "too late" since I had not realized I had shingles and was past the 72 hour window so it may be less effective. Prescribed gabapentin 300 mg three times/ day for 7 days for nerve pain. Recommended using lidocaine and capsaicin cream 3 times/ day, too. I started treatment with all 4 of these right away. Dr. also advised me that she did not think the shingles were per se caused by the covid vaccine, but because it appeared in close proximity to my dose #2 (and I had side effects for several days indicating a strong immune response) that I should report it to the CDC just in case - which is why I am filing this report. May 20: Rash on my back continued to spread all the way to my spine. Rash on chest worsened/ turned bright red. Back pain was extreme and not controlled by gabapentin. Pin pricks on wrist never turned itchy/ into blisters - I think they actually were heat rash from my watch. Bump on my left ankle appears to be a bug bite. I started getting periodic (every hour or two) sharp pains in my left ear, but no tinnitus. Periodic sharp pains in left side, left shoulder, and along my spine. Constant deep ache along my spine, and tenderness on my left side. Extremely fatigued. Taking gapapentin, valacyclovir 3x/day, and administers capzacin cream + a lidocane patch for areas of pain that do not have open wounds. May 21: For the first time the rash appears to be the same, or maybe even slightly improved from last night in terms of appearance. The back pain and skin tenderness is the same. Ear pain is more frequent - almost like I have an ear infection, with periodic sharp jabs multiple times an hour, but no tinnitus. Taking gapapentin, valacyclovir 3x/day, and administers capzacin cream + a lidocane patch for areas of pain that do not have open wounds.
33 2021-05-21 loss of taste Initial 2 days sore arm and nausea. Nausea continued for next few days. Day 4 Friday 4/30/21 lost ta... Read more
Initial 2 days sore arm and nausea. Nausea continued for next few days. Day 4 Friday 4/30/21 lost taste so had COVID test which came back negative. Saturday 5/1/21 had headache and high blood pressure. Had video visit with doctor who told to take Motrin/Advil.Headache did not go away even after medicine. Sunday 5/2/21 high bp and numbness in face and limbs. Had tingling in body.Went to ER. Did EKG,Blood work, CT of skull ,CT of Spine which came back normal. No medications given and came back home. Er suggested to visit Neurologist in few days.Was feeling tingling and bp was still high and headache. Wednesday evening 5/5/21 had chest pain and sweating so went to ER again. Done EKG,Bloodwork and Chest X Ray which came back normal. No medicines given and sent back home. Thursday 5/6/21 visited primary care doctor as headache was still there on and off and tingling. Bloodwork done which was okay. Sunday 5/9/21 visited Urgent Care due to pain in Legs. Monday 5/10/21 Leg ultrasound done as ordered by doctor. Reports mentioned mild muscle spasms. Started to feel better. Still had tingling feeling and headache on and off. Tuesday 5/18/21 visited Neurologist as recommended by ER. She checked reports and said looked good. Need to take Migraine medicine if heavy headache. Follow up after two months to see if MRI would be required. Headache has now reduced but still it is on and off.
33 2021-05-23 visual impairment Resting heart rate (HR) was at 64, resting blood pressure (BP) prior to vaccine was at 107/68 (Which... Read more
Resting heart rate (HR) was at 64, resting blood pressure (BP) prior to vaccine was at 107/68 (Which is historically normal for me) About 30 minutes after vaccination the lights in the room started to appear as streaks. My HR shot up to 99 and BP was at 135/83. (My heart felt like it was going to burst out of my chest.) This level of elevated cardiovascular output was endured for about 3 hours. Treatment included meditation and conscious, focused intent to slow HR down and reduce BP. Lymph nodes were rock hard and it became difficult to talk or swallow. This seemed more of a normal vaccine response, it only lasted for about an hour, after I took my immune boosting supplements.
33 2021-05-24 ear itchiness Pfizer-BioNTech COVID-19 Vaccine EUA - About 10 minutes after receiving her second dose of the Pfize... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - About 10 minutes after receiving her second dose of the Pfizer covid-19 vaccine, pt experienced full body itching and ear itching. Pt reported a history of skin allergies and sensitivity to detergent. No history of adverse reactions to any other vaccine. Recommended pt be observed for an additional 15 mins (she waited for 30 mins total). After a total of 30 mins in the observation area pt felt comfortable leaving and symptoms resolved.
33 2021-05-25 blindness, ringing in ears Dizziness, Lightheaded, Gray-out, Ears ringing
33 2021-05-25 conjunctivitis pinkeye in both eyes; nausea; mild fever; joint pain; fatigue; sciatica; This is spontaneous report ... Read more
pinkeye in both eyes; nausea; mild fever; joint pain; fatigue; sciatica; This is spontaneous report from a contactable consumer (patient). A 33-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0169) via an unspecified route of administration on 24Apr2021 at 14:15 (at the age of 33-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included anxiety, irritable bowel syndrome (IBS), and penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole, sertraline, hydroxyzine hcl, and buspirone hydrochloride (BUSPAR) from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EW0150) on 03Apr2021 at 10:00 as a single dose in the right arm for COVID-19 immunization. ON 25Apr2021 at 03:30 the patient woke up with pinkeye in both eyes. She also experienced nausea, mild fever joint pain, fatigue, and sciatica. The events were reported as non-serious. The patient was not hospitalized as a result of the events. The patient was treated with pinkeye drops: polymyxin B and trimethoprim. The outcomes of nausea, mild fever, joint pain, fatigue, sciatica, and pinkeye were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
33 2021-05-25 lip swelling I felt like my throat was swelling and closing up followed by swelling of the lip; I felt like my th... Read more
I felt like my throat was swelling and closing up followed by swelling of the lip; I felt like my throat was swelling and closing up followed by swelling of the lip; I felt like my throat was swelling and closing up followed by swelling of the lip; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ew0182), via an unspecified route of administration at Left arm on 20May2021 12:00 (at the age of 33-year-old) as single for COVID-19 immunisation. Medical history included migraine, asthma and peanut allergy. Concomitant medications included rizatriptan and amitriptyline. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20May2021 at 12:15, patient experienced i felt like my throat was swelling and closing up followed by swelling of the lip. Patient received Benadryl and Ventolin as treatment for event to reduced symptoms. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received. Therapeutic measures were taken as a result of i felt like my throat was swelling and closing up followed by swelling of the lip. The outcome of the events was recovering.
33 2021-05-25 ringing in ears Warm/tingle feeling up neck and into ears at time of vaccination (immediate onset) Swollen lymph nod... Read more
Warm/tingle feeling up neck and into ears at time of vaccination (immediate onset) Swollen lymph nodes in the neck and armpit on left side of body - onset 2 days post vaccination. Lasted about 1 week Congestion and ringing in ears - onset immediate. Lasted about 3 weeks
33 2021-05-25 ringing in ears Vertigo, nausea, ear ringing, rapid heartbeat, lightheadedness
33 2021-05-27 mouth tingling, mouth numbness, feeling of choking, swollen tongue Swelling and numbness/tingling in lips, tongue, face, throat. Dizziness/disorientation
33 2021-05-28 mouth tingling headache; tingling to tongue lips and mouth; bp (blood pressure) 160/90; P107 (Pulse) RR (respirator... Read more
headache; tingling to tongue lips and mouth; bp (blood pressure) 160/90; P107 (Pulse) RR (respiratory rate) 18; P107 (Pulse) RR (respiratory rate) 18; This is a spontaneous report from a contactable nurse. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 33-year-old, intramuscular, administered in left arm on 13May2021 10:00 (Lot Number: ew0183) as 1st dose single for COVID-19 immunisation. The patient has no medical history. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and other medications within 2 weeks of vaccination. On 13May2021 at 10:00, shortly after her Pfizer vaccine she developed a headache and tingling to tongue lips and mouth. No swelling noted no hives noted. The patient was given 25mg PO (oral) diphenhydramine (BENADRYL) for the headache and tingling to tongue lips and mouth per protocol and EMS (Emergency Medical Services) called. Patient was speaking in full sentences. The patient's VSS (vital signs stable), BP (blood pressure) 160/90, P (pulse) 107, RR (respiratory rate) 18, RA (respiratory) 99% all on 13May2021. The patient was in no acute distress and reports tingling not getting worse. Patient was transported to HMH (health level) ED (emergency department) for evaluation. The events resulted in Emergency room/department or urgent care. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
33 2021-05-30 sensitivity to light, extreme sound sensitivity 1st: 5 minutes after I felt flush and had an elevated heart rate & blood pressure which usually runs... Read more
1st: 5 minutes after I felt flush and had an elevated heart rate & blood pressure which usually runs low. The following two days I had sensitivity to light and louder sound, as well as, some nausea when slightly physically active. Fatigue for about 3 days and a swollen lymph node from day 3-7 after injection. Also soreness at injection site for 2-3 days. 2nd: No immediately reaction like last time. This time more covid like symptoms: fatigue, sore throat, and a minor cough with phlegm. Although I did notice some irritability for 2-3 days following the injection.
33 2021-05-31 loss of smell, taste impairment chills, dysgeusia, anosmia, chills, congestion
33 2021-05-31 mouth numbness Numbness in lips; Numbness in fingers; Numbness in toes; This is a spontaneous report from a contact... Read more
Numbness in lips; Numbness in fingers; Numbness in toes; This is a spontaneous report from a contactable Consumer. A non-pregnant female patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) 2nd dose (lot/batch no: not available/provided to reporter at the time of report completion) for covid-19 immunization, administered in right arm on 11Mar2021 at 16:15pm. Medical history included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot/batch no: not available/provided to reporter at the time of report completion) for covid-19 immunization, administered on left arm on 18Feb2021 at 16:15 hours. Concomitant medication included Sertraline. The patient had taken sertraline within 2 weeks of covid-19 vaccination. The patient had no allergies of food, medications and other products. The patient experienced numbness in fingers, lips and toes on 16March2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient had not been tested COVID-19 since the vaccination. No therapeutic measures were taken. The patient was not pregnant at the time of vaccination. The patient had not recovered from the events at the time of reporting. No follow-up attempts are possible. information about lot/batch number cannot be obtained. No further information is expected.
33 2021-05-31 lip swelling Patient endorsing throat tightness, difficulty talking deep breath, swelling of face and lips post #... Read more
Patient endorsing throat tightness, difficulty talking deep breath, swelling of face and lips post #2 covid vaccine. Premedicated at home with singulair last night and this morning. VSS, 02 100%, slightly tachycardic, hypertensive with ongoing stressors of appointment. No chest pain or palpitations. Due to ongoing HSR symptoms and lack of response to premedications at home, administered EPIPEN in infusion room at 105pm in right lateral thigh. VSS monitored every 10 minutes remained stable. Continued to report mild throat tightness, slight improvement in breathing, improvement in facial edema. Administered Benadryl 25mg IM in clinic, referred to ED for continued monitoring due to incomplete resolution of symptoms. Of note, patient is able to tolerate low doses of benadryl, experiences pruritus with high dosing. Unable to obtain IV access to collect tryptase level in light of HSR, requested to obtain at ED in order to avoid delay in transit.
33 2021-05-31 mouth tingling, swollen tongue, taste impairment Knot in arm 2 inches below injection site: 5/28/2021-5/29/2021 pain at injection site: 5/28/2021-5/2... Read more
Knot in arm 2 inches below injection site: 5/28/2021-5/29/2021 pain at injection site: 5/28/2021-5/29/2021 diarrhea: 5/28/2021 throughout the day nausea: 5/28/2021-5/30/2021 intermittently throughout the day extreme fatigue: 5/28/2021-5/31/2021 all day everyday extreme dizziness: 5/28/2021-5/31/2021 intermittently throughout the day; not as much on 5/29/2021, but the worst on 5/30/2021 menthol metallic taste in mouth and throat: 5/28/2021-5/31/2021 intermittently throughout the day slight tingle and swelling of tongue: 5/28/2021 intermittently throughout the day red face: 5/28/2021-5/29/2021 throughout the days whenever walking hot and sweaty then followed by fully body chills: 5/28/2021 intermittently throughout the day chills: 5/28/2021-5/30/2021 intermittently throughout the day
33 2021-06-01 dry eye After the second injection, I was experiencing what I thought was a lupus flare up. I needed to get ... Read more
After the second injection, I was experiencing what I thought was a lupus flare up. I needed to get into a new rheumatologist so that took some time getting into with my current insurance. I was experiencing a tremendous amount of joint and muscle pain. I have a Low grade fever off and on as well as my lupus butterfly rash on my face and a few sores in my nose. All symptoms I have had when dealing with a lupus flare. One thing that was different was muscles being pulled for doing very little. My back and neck muscles kept getting pulled often. Extreme dry eyes/nose- all which was similar autoimmune symptoms I have had in the past. Extreme periods of nausea, but I have been unable to take certain medications I use to be able to take. I can not take any nausea medications because it now will give me a horrible migraine that last for days. My primary doctor gave me a steroid dose pack to help me until I could get into my rheumatologist and I had a horrible reaction to them with extreme diarrhea, nausea, vomiting, and migraines. None of those symptoms to medications has happened in my past. My symptoms started was a gradual increase over the time period after getting my vaccine. Not all at once. But after about a week after getting the vaccine it started to happen slowly to the point where I am today. The doctors ran various test for my lupus and all of my inflammation lab markers came back extremely high. But none of my lupus/autoimmune markers came back as active. I also ended up going to the ER concerned with chest pain- but after many test nothing was conclusive or found. I have a follow up with a cardiologist pending
33 2021-06-02 deafness, ringing in ears On the evening of 04/10/2021 (after first Pfizer COVID-19 vaccine), tinnitus in right ear flared to ... Read more
On the evening of 04/10/2021 (after first Pfizer COVID-19 vaccine), tinnitus in right ear flared to an excruciatingly high pitch and high volume, of which had not been experienced before. On the morning of 04/15/2021, I first began to experience dizziness as the tinnitus continued at a high level. As the day progressed I experienced hearing loss in the right ear along with "fullness" in the same ear. On this same day I experienced vertigo with a spinning room sensation which caused me to vomit. I also began to have trouble with balance. The intense vertigo subsided within two days, but for about three weeks I felt dizzy and had trouble with balance. On 04/22/2021 a hearing test confirmed sudden loss of hearing in my right ear. I was immediately placed on a 10 day regimen of prednisone steroids. Within days of starting the steroid, my tinnitus returned to its normal low level and I felt my hearing return as well. On 05/04/2021 a balance test confirmed 40% reduction of balance on right side as compared to left side, but it has been compensated for. On 05/06/2021 an MRI Intra-auditory Canal with Contrast demonstrated findings consistent with hydrops from the right ear canal. On 05/13/2021 I received my second Pfizer COVID-19 vaccine and experienced no symptoms of dizziness, balance or hearing loss, nor increased tinnitus. Chills, a slightly tender arm and fatigue were the only side effects I experienced from the second shot. On 05/20/2021 a second hearing test demonstrated returned hearing in my right ear and both ears were symmetrical. In summation, my reaction to the first Pfizer COVID-19 vaccine started within hours of injection, with extreme tinnitus in my right ear. Then, five days later, I experienced hearing loss in my right ear for about a week before the loss was confirmed by a hearing test. My PCP started me on prednisone the day of my hearing test. The steroids preserved and restored my hearing within days and lessened my tinnitus. Also five days after the first vaccine, I experienced intense vertigo for a couple days and lingering dizziness with balance issues for about three weeks. It took me about a month to feel comfortable enough to drive. I experienced little to no adverse side effects from the second Pfizer COVID-19 vaccine.
33 2021-06-02 eye itchiness, swelling of eyelid About 3 hours after receiving the first dose, my right eye began to itch but there wasn't any thing ... Read more
About 3 hours after receiving the first dose, my right eye began to itch but there wasn't any thing physically seen on the day I received the vaccine. When I woke up the next morning on Friday, May 28th, I noticed my eyelid (the part that's closer to the lashes) had swollen up. Saturday morning, it had swollen more than it had the previous day. I tried placing a hot wash cloth over my eye. My eyelid was super tender and the slightest touch to the eyelid hurt. Sunday, I decided to make it to the ER. Although they couldn't confirm that it was an allergic reaction (even though I told them it was), the doctor saw how it was swollen and tender. I was given 3 different medications to take. It is now day 5 and it seems as though it has worsened because it's now the whole eyelid. It's painful. When I had to get something off the floor or tie my shoe, it feels like drainage is rushing towards the front of my head and causing the pain in my eye.
33 2021-06-02 mouth numbness, swollen tongue Arm sore; rash on chest; tight chest; numbness and swelling on left side of face; numbness and swell... Read more
Arm sore; rash on chest; tight chest; numbness and swelling on left side of face; numbness and swelling on left side of face; numbness and swelling on left side of face, throat; numbness and swelling on left side of face, throat; numbness and swelling on left side of face, throat, and tongue.; numbness and swelling on left side of face, throat, and tongue; This is a spontaneous report received from a contactable other health care professional (Patient herself). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration (at the age of vaccination 33-year) in Left Arm on 07Mar2021 10:30 as 1st dose, single for COVID-19 immunization. Medical history included asthma, Known allergies, endometriosis, anxiety and depression. Concomitant medications included fluoxetine hydrochloride (PROZAC); clonazepam (KLONOPIN); albuterol (SALBUTAMOL); elagolix sodium (ORILISSA) and lamotrigine (LAMICTAL). The patient haven't tested COVID prior and post vaccination. On 07Mar2021 10:30 the patient experienced arm sore, rash on chest, tight chest, numbness and swelling on left side of face, throat, and tongue. Therapeutic measures were taken as a result of the events. The patient visited Emergency room for the events. Patient was treated with Epi-pen, benadryl, albuterol, prednisone. The seriousness of the events was reported as non-serious. The clinical outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
33 2021-06-02 mouth tingling, oropharyngeal discomfort, lip swelling Tingling in mouth, lips; Slight swelling of lips; Weird feeling in throat; This is a spontaneous rep... Read more
Tingling in mouth, lips; Slight swelling of lips; Weird feeling in throat; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0171, at the age of 33-year, on 06May2021 12:30 at single dose in left arm for COVID-19 immunization. Medical history included Irritable bowel syndrome (IBS). The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications included ergocalciferol (VIT D), ascorbic acid (VIT C), vitamin b complex (VIT B COMPLEX) and zinc chloride. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received Hyoscyamine and Gantrisin and experienced allergy. On 06May2021 12:45, the patient experienced Tingling in mouth, lips; Weird feeling in throat; Slight swelling of lips. Nurses administered Benadryl on site. The outcome of the events was resolved in May2021.
33 2021-06-02 mouth tingling tongue tingling, shortness of breath, excessive sweating, dizziness, shaking
33 2021-06-04 mouth tingling Throat swelling and closing; Throat swelling and closing; burning sensation on face/cheeks; tingling... Read more
Throat swelling and closing; Throat swelling and closing; burning sensation on face/cheeks; tingling lips; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6199 and expiry date was not provided), via an unspecified route of administration in left arm on 07Mar2021 at 15:15 (at the age of 33-years-old) as a single dose for covid-19 immunisation. Medical history included allergies to penicillin and cephalosporins. Concomitant medication(s) included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, biotin, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, docosahexaenoic acid, folic acid, iron, nicotinamide, pantothenic acid, potassium iodide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, zinc oxide (VITAPEARL) taken for prenatal care, start and stop date were not reported. The patient previously received pertussis vaccine and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Mar2021 at 15:30 (10-15 minutes after administration), patient experienced throat swelling and closing, burning sensation on face/cheeks and tingling lips. The outcome of the events were recovering. Therapeutic measures were taken as a result of throat swelling and closing, burning sensation on face/cheeks and tingling lips with oral Benadryl. No follow-up attempts are possible. No further information is expected.
33 2021-06-05 swollen tongue Patient had reported facial rash approximately 1 hour after her first vaccine, resolving after <24 h... Read more
Patient had reported facial rash approximately 1 hour after her first vaccine, resolving after <24 hours. No other symptoms to suggest serious allergic reaction and no reported h/o other serious allergic reaction in past. She was pretreated with 25 mg oral diphenhydramine before her 2nd vaccine dose and placed in the 30 minute observation area. She developed sensation of tongue swelling just over 20 minutes after vaccine dose and was brought to medical tent. Vitals were within normal limits. She was not in distress. She continued to complain of tongue swelling. No difficulty breathing or swallowing, no rash or nausea. Epi-pen was administered as well as additional diphenhydramine 25 mg. Medics called. Repeat vitals stable. She improved after epi-pen but subsequently developed complaint of throat tightness and was noted to have mild facial flushing approximately 15 minutes later, therefore a second epi-pen was administered. Medics arrived shortly thereafter and she was transferred to hospital. During her observation period she disclosed that she had had a serious reaction to Sulfa in childhood but was not sure what it was. She had not previously disclosed this.
33 2021-06-07 eye pain Acute headache on right side of head and eye. Today after one week I still have severe headaches dai... Read more
Acute headache on right side of head and eye. Today after one week I still have severe headaches daily.
33 2021-06-08 mouth tingling Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-ol... Read more
Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: Ep6955), via an unspecified route of administration in right arm on 07Jan2021 at 08:00 as a single dose (at the age of 33 years old) for COVID-19 immunisation. Medical history included asthma, recurrent pneumonia, chronic sinusitis, birch pollen allergy, some nuts allergy, and dust allergy. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received treatment with BENADRYL for the reported event. On 07Jan2021 at 08:45, tingling tongue. The clinical outcome of event tingling tongue was recovering. No follow-up attempts are needed. No further information is expected.
33 2021-06-09 feeling of choking 15 minutes after receiving vaccination I got a tingling sensation in my throat and then it felt like... Read more
15 minutes after receiving vaccination I got a tingling sensation in my throat and then it felt like a lump in my throat. EMS was called and I received Benadryl and prednisone. 9 days later I saw my general practitioner 9 days later because my throat was still swollen. She prescribed me Pepcid and I have to go for a thyroid ultrasound.
33 2021-06-12 sensitivity to light, extreme sound sensitivity Fever up to 102 on and off for 4 days, chills for 4 days, nausea is still on going, vomiting, vertig... Read more
Fever up to 102 on and off for 4 days, chills for 4 days, nausea is still on going, vomiting, vertigo is still on going, sensitivity to light and sound for 2 days. Body aches and pains for 4 days consistently but now it?s lightened up but hasn?t gone away completely. I?m going to contact my doctor if the symptoms doing go away by tomorrow. It?s Sunday so their office is closed.
33 2021-06-12 ringing in ears Tinnitus lasted for about one week after first dose and came back again after second dose. Tinnitus ... Read more
Tinnitus lasted for about one week after first dose and came back again after second dose. Tinnitus gets worse these days.
33 2021-06-12 ringing in ears Tinnitus
33 2021-06-13 mouth tingling PT STATES SHE FELT SOME TINGLING IN HER TONGUE FOLLOWING THE VACCINATION. SHE DENIES ANY ISSUE AFTE... Read more
PT STATES SHE FELT SOME TINGLING IN HER TONGUE FOLLOWING THE VACCINATION. SHE DENIES ANY ISSUE AFTER THE FIRST DOSE. SHE ARRIVES ON MED OBS 1 AT 0801. 08:05 -- HR 84 BP 120/80 RESP 16 OXYGEN SAT 100% ROOM AIR. WHILE SHE WAS BEING OBSERVED SHE STATED THAT SHE HAD WORKED ALL NIGHT, HAD NOT EATEN ANYTHING FOR BREAKFAST. SHE STATES THE SYMPTOMS HAVE GONE AND WOULD LIKE TO GO. SHE WAS ESCORTED TO THE EXIT BY STAFF AS SHE LEFT WITH A FRIEND AT 08:15.
33 2021-06-15 eye swelling I developed trigeminal and eye shingles at 7 months of Long Covid and was on Valtrex to keep the vir... Read more
I developed trigeminal and eye shingles at 7 months of Long Covid and was on Valtrex to keep the virus dormant. After the 2nd vaccine dose, and after 2 days had passed, I developed shingles lesions in the exact same location as I had when I developed eye shingles. I had 4 raised lesions, a swollen left eye and cheek, a tender left cheek, and nerve pain. The shingles outbreak lasted for 3 days and then subsided. I was consistently on Valtrex before, during and after my vaccination and the lesions still occurred.
33 2021-06-15 mouth numbness Patient immediately felt sensation at injection site that immediately spread up towards neck and chi... Read more
Patient immediately felt sensation at injection site that immediately spread up towards neck and chin area which converted into numbness of the area within minutes. Sensation was not painful. Patient had feeling of overwhelm but disregarded both the sensation and overwhelm as anxiety of the vaccination process in general and did not report to the available medical staff. Numbness remained for approximately 24 hours primarily in the chin and bottom lip with some loss of feeling in the upper lip. No sign of swelling.
33 2021-06-16 vision blurred Pt complained of blurry vision 20 mins post 2nd vaccine. Taken to ED. EKG normal. Discharged home... Read more
Pt complained of blurry vision 20 mins post 2nd vaccine. Taken to ED. EKG normal. Discharged home. On 5/30 pt presented to the ED with severe fatigue, lightheadedness and HR changes. Tests performed were all negative (EKG). Patient discharged home.
33 2021-06-17 bleeding gums I start feeling not well that night, I started having bad muscle aches, nauseated, dizziness, light ... Read more
I start feeling not well that night, I started having bad muscle aches, nauseated, dizziness, light headed. I felt extremely fatigued. I tried to sleep and next day I had diarrhea. Everything I ate didn't stay in my body. I took ibuprofen. I called my neurologist, he had me call my primary doctor. I called my primary on Tuesday, my gums started bleeding and I had a rash. My primary told me to call back if symptoms continue. I called my primary on Friday he had me go to the ER. I went Health clinic at town.
33 2021-06-17 ringing in ears Ringing in the ears!!!!!!!
33 2021-06-20 visual impairment, light flashes or floaters in the eye On the 9th of April about 3:40pm about 10 minutes after the vaccine I felt faint and waived the Doct... Read more
On the 9th of April about 3:40pm about 10 minutes after the vaccine I felt faint and waived the Doctor over because of my allergy to contrast dye I was in a section of people to be watched but I called my Dr. before the vaccine and he said I could get the vaccine. So I waived someone and they put me on a stretcher and I was in and out of consciousness for around 90 minutes so I fainted and from that point I experienced Alice In Wonderland Syndrome for the next 3-4 weeks. This is something I have since I was a child but I only get it when i have a fever so the difference is that I had no fever and was stuck in Alice In Wonderland mode so it wasn't safe to drive. The next day april 5th and I started having diarrhea and haven't had a regular bowel movement until this day. It hasn't gone away. That day also April 10th I started having breathing problems where my breathing was very shallow and it was the first time i called my Dr and asked for an appointment but at that time there wasn't enough lab work to know what was going on. Later that week around 12/13th I started having extreme fatigue and dizziness with trouble going up and down the stairs and stuck in Alice In Wonderland mode so i fell down a lot. I had trouble walking and walking my dog and started getting migraines without head pain with little lights flashing and circles that expanding, having a lot of those for several weeks but no head pain so it was odd. My last symptom before my second vaccine between 23/26 I started to feel that my limbs were really heavy and I was sleeping a lot and had a really hard time getting up in the morning and short of breath and still tired after sleeping 11 hours and that's when I got my 2nd vaccine.
33 2021-06-23 ear pain short of breathe, body aches, chills, ear aches cough, congestion, fatique
33 2021-06-24 mouth numbness Left foot tingling; Tongue and nose numb; Tongue and nose numb; Lymph node was very swollen; This is... Read more
Left foot tingling; Tongue and nose numb; Tongue and nose numb; Lymph node was very swollen; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in right arm on 28Jan2021 at 12:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. No known allergies. Concomitant medications included escitalopram, birth control; Both received within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. No COVID prior vaccination. The patient has been tested for COVID post vaccination. On 28Jan2021 at 12:00, the patient experienced left foot tingling, tongue, and nose numb, lymph node was very swollen. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test and procedure which included rapid nasal swab: Negative on 02Feb2021. No treatment medications was received for the adverse events. The outcome of the events was not recovered. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
33 2021-06-24 mouth swelling, swollen tongue, eye swelling Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient reported difficulty breathing/throat closing and swelling of tongue 10 minutes after getting the vaccine. I immediately gave Epinephrine 0.3 mg injection and a 25 mg benadryl tablet and called 911 immediately. Patient reported feeling better after 10 minutes. Emergency Medical services arrived within 10 minutes. They checked her vitals and all vitals were normal. Patient refused to be taken to ER and the EMT documented her refusal.
33 2021-06-25 eye swelling, eye pain Right eye is very painful; Right eye is very swollen; This is a spontaneous report from a contactabl... Read more
Right eye is very painful; Right eye is very swollen; This is a spontaneous report from a contactable consumer, the patient. A 33-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: UNKNOWN) as a single dose via unspecified route on 18Mar2021 at 10:15 AM (at the age of 33-year-old) for COVID-19 immunisation. Medical history and concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, the patient experienced right eye is very painful and swollen almost to the point, cannot open it. The patient didnot received any treatment for the events. The clinical outcome of right eye is very painful and swollen was not recovered at the time of report. No further information is expected, information about lot/batch number cannot be obtained.
33 2021-06-27 light flashes or floaters in the eye After the 2nd dose, around the end of May 26, 2021, I started seeing flashing and different color li... Read more
After the 2nd dose, around the end of May 26, 2021, I started seeing flashing and different color lights of purple and yellow in the left eye. It was very bad for 1 week. It was flashing so much and distracting and I could not drive. It did start to improve and I have seen weekly improvements but has not completely resolved. I went to see a doctor who indicated that something is tugging on the "vitrous humor" and should go away. I am being followed by the eye specialist.
33 2021-06-28 eye pain, eye swelling woke up with allergy all over the body; rash all over my body; minor pain; pain and swollen eyes; pa... Read more
woke up with allergy all over the body; rash all over my body; minor pain; pain and swollen eyes; pain and swollen eyes; Swelling all over my face; my neck and my body is very red and Itchy; my neck and my body is very red and Itchy/body very red like sunburn; Nausea; This is a spontaneous report from a contactable consumers (one of them is the patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0168) via an unspecified route of administration into left arm on 10Jun2021 (at the age of 33-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jun2021 patient woke up with allergy all over the body, rash all over the body, minor pain, pain and swollen eyes, swelling all over the face, neck and body is very red; further reported as body was very red like sunburn and itchy and nausea. Patient went to the emergency room and was given a shot of steroid and a shot of Benadryl. Outcome of event "nausea" was unknown while the outcome of all other events was not recovered.
33 2021-06-29 ringing in ears Small bouts of diarrhea; Tinnitus; This is a spontaneous report from a contactable consumer, the pat... Read more
Small bouts of diarrhea; Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 33 year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Eh6705) via an unknown route of administration in the left arm on 11Mar2021(at an age of 33 year-old) at 12:15 as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN), daily multivitamin (MANUFACTURER UNKNOWN) all for unknown indication. The patient did not receive any other vaccine within 4 weeks, prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Mar2021, the patient experienced diarrhea and on an unknown date in Mar2021 the patient experienced tinnitus. The patient reported mid tinnitus was not constant; which came and went. The patient did not receive any treatment for the events. The patient had not been tested positive for COVID-19 since having the vaccine. The clinical outcome of mild tinnitus resolved with sequelae on an unknown date in Mar2021 while the clinical outcome of the event diarrhoea was resolved with sequelae on 12Mar2021 . No follow-up attempts are needed. No further information is expected.
33 2021-06-30 hearing loss Morning following vaccination, patient had diffuse rash and nausea. Presented to ED and progressed t... Read more
Morning following vaccination, patient had diffuse rash and nausea. Presented to ED and progressed to lightheadedness, difficulty hearing and hypotension. Patient took diphenhydramine at home prior to presentation to ED. Epinephrine was administered in the ED.
33 2021-07-04 eye pain patient reported on 7/5/21 that on Wednesday after her vaccine she experienced rash on stomach, arms... Read more
patient reported on 7/5/21 that on Wednesday after her vaccine she experienced rash on stomach, arms, back, legs, headaches, eyes hurting, legs and back hurting, stomach cramping and neck hurting. she also reported right sided pain over whole body and numbness in her face. Patient showed me redness on stomach, recommendedBenadryl. Patient stated she had already been to the doctor (ruled out bells palsy or stroke due to no facial droop).
33 2021-07-06 chapped lips, swollen lips, lip pain 1. June 24th (24 hours): Mouth lesions. Headache. Vaginal bleeding 2. Sunday June 27th (96 hours): S... Read more
1. June 24th (24 hours): Mouth lesions. Headache. Vaginal bleeding 2. Sunday June 27th (96 hours): Severe oral blistering and cheilitis. Odynophyagia. White plaques on tonsils. Painful lymphadenopathy in the neck. T max: > 38 degrees. Reduced to liquid diet. ER Visit Sunday June 27th. Provisional dx of HSV. But HSV swap negative. Sent home with supportive care. 3. Tuesday June 29th (134 hours): Virtual consult. Rx Magic mouth. Oral Rx for Valacyclovir. 2000 mg PO x 2 doses. 4. July 2nd: Lesion on lips still present. Some improvement in pain. 5. July 7th: Oral lesions gone. One crack/fissure in the lower lip remained.
33 2021-07-07 mouth numbness, mouth tingling Pt called hospital call center 5/14/2021 regarding of covid vaccine side effects. Noted no emergen... Read more
Pt called hospital call center 5/14/2021 regarding of covid vaccine side effects. Noted no emergency s/sx shown. Pt stated pt got 1st covid vaccine Pfizer at vaccination site 5/14/2021 and got feeling left jaw line and lip numbness, tingling, warm touch after 40 minutes from vaccination. Assessed facial nerve status, noted pt sees her face looks in symmetrical on mirror. Pt is educated covid vaccine side effects. Informed pt to call 911 or go to ED if pt experienced emergency s/sx or facial nerve abnormal. Pt scheduled urgent care telephone visit 5/16/2021 for consultations.
33 2021-07-08 ear itchiness "Pt w/ allergies to Latex (rash) and Amoxicillin (rash). Pt also has intolerance to Norco (N/V/Dizzi... Read more
"Pt w/ allergies to Latex (rash) and Amoxicillin (rash). Pt also has intolerance to Norco (N/V/Dizziness). Pt PMH notable for Asthma, Lupus, unspecified neurological abnormality, clotting disorder (clotted post knee surgery in 2015), Depression. 16mins post vaccination pt c/o itchy ears and throat and slight swelling of the throat. Pt c/o trouble swallowing. Pt administered 0.3mg Epi @16:24. Vitals @16:23 BP 125/78, HR 78, RR 16, SpO2 100% RA -- >111/62, 60, 16, 100% RA -- > 118/65, 64, 16, 100% RA. Pt stable and released from the vaccination site. Pt was notified that second dose Pfizer appt was cancelled and appt for J&J made in 28days. Pt may decline J&J. Current Medications: ergocalciferol 50000Units PO Q7days cholecalciferol 1000Units PO daily Ca-Vit D3 500mg-200unit PO BID"
33 2021-07-08 lacrimation increased Very intense sneezing; Stuffy nose; Eyes watering; Runny nose allergy attack at midnight; Trouble sl... Read more
Very intense sneezing; Stuffy nose; Eyes watering; Runny nose allergy attack at midnight; Trouble sleeping all night; Arm soreness; This is a spontaneous report from a contactable other health care professional, the patient. A 33-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via unspecified route of administration in left arm, on 26Mar2021 at 13:15 (at the age of 33 years) as a single dose for COVID-19 immunisation. Medical history was not provided. The patient previously received codeine (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since having the vaccine. Concomitant medications included ambien (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), vyvanse (MANUFACTURER UNKNOWN), doxylamine (MANUFACTURER UNKNOWN) and armour thyroid (MANUFACTURER UNKNOWN) all for unknown indications from unknown dates and unknown if ongoing. On unknown date in Mar2021, the patient experienced arm soreness, very intense sneezing, stuffy nose, eyes watering, runny nose allergy attack at midnight and trouble sleeping all night. The patient received albuterol breathing treatment, ibuprofen, zyrtec, afrin treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events arm soreness, very intense sneezing, stuffy nose, eyes watering, runny nose allergy attack at midnight and trouble sleeping all night were not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
33 2021-07-08 visual impairment, mouth tingling, eye twitching slight headache; Brain fog; Urine feel hot; can't sleep; felt like had flu; felt every hot in the in... Read more
slight headache; Brain fog; Urine feel hot; can't sleep; felt like had flu; felt every hot in the inside; sweating; Knees became week; vision go black twice when I blinked; tingly sensation around mouth area; Burning sensation in back of head, left side of neck and back of neck, on arms and legs; Random leg pain; Pressure on back of head which comes and goes; Eye twitches; Fatigue; weakness; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL 9264) via an unspecified route of administration in the left arm on 17Mar2021 at 10:00 (at the age of 33-years old) as a single dose for COVID-19 immunisation. Medical history included Vitamin D deficiency. The patient did not have any known allergies to medications, food, or other products. The concomitant medications included multiple vitamins and VITAMIN D nos 50,000UI. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 17Mar2021 at 11:15, the patient experienced tingling sensation in mouth area, burning sensation in the back of head, back and left side of neck in arms and legs, leg pain, tingling sensation of lips, pressure on the back of head which used to come and go, left eye twitching, fatigue and weakness. On 23Mar2021 the patient felt the knees to be very weak and used to get a feel of falling, while walking in the room the patient on blinking felt the vision to go black twice. On 24Mar2021 patient felt to have flu like symptoms were feeling hot was experienced from inside and was sweating and had fatigue with a normal temperature. On 25Mar2021, the burning sensation was there all day long which prevented the patient from sleeping, slight headache, foggy brain, feeling hot from inside and having a sensation of hot urination. The patient was prescribed to take BENADRYL but it didn't help much for the patient. Therapeutic measures were taken as a result of reported events and included treatment with BENADRYL. Since the vaccination the patient was tested for COVID-19 nasal swab test (HDPCR SARS-CoV-2) on 23Mar2021 and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcomes for the events such as tingling mouth, burning sensation, leg pain, tingling lips, head pressure, eye twitching, fatigue, weakness, joint weakness, vision went black, feeling hot, sweating, headache, foggy feeling in head, painful urination and sleeplessness were unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
33 2021-07-09 ringing in ears, drooping eyelid, eyelid function disorder, eye pain, dry eye Pulsatile tinnitus, Pain in the left cranial ocular region, inability to close eyes properly resulti... Read more
Pulsatile tinnitus, Pain in the left cranial ocular region, inability to close eyes properly resulting in corneal ulcer, hot flashes for two plus weeks, night sweats, irregular menses, heart pain and cardiovascular impairments all within the first month following. Onset began the day after vaccination. Menses has returned to normal two months later. Two months post vaccination, tinnitus is still present, dry eye and drooping left eye indicating mild Bell's palsy reaction. Heart inflammation still present.
33 2021-07-10 ringing in ears The client reported that the next day she developed dizziness. The client states she had experienced... Read more
The client reported that the next day she developed dizziness. The client states she had experienced approximately 4 episodes of dizziness that last about three minutes each. The client states the episodes of dizziness happen almost daily. The client also stated she felt nausea the day after the vaccine. The client also reported "ringing in her right ear" about one week after she received the vaccine which resolved after about 40 seconds. The client denied any injuries related to the dizziness. The client stated there have been episodes of dizziness where she had to sit down. The client described the episodes of dizziness "like I'm floating." Vitals obtained were as follows BP 120/70, HR 81, and O299%. The client did not report shortness of breath after the first dose of COVID vaccine Pfizer.
33 2021-07-11 mouth tingling Immediately upon receiving injection I had tingling/numbness in my left arm that went all the way to... Read more
Immediately upon receiving injection I had tingling/numbness in my left arm that went all the way to my hand. I had weakness in my left hand. 25 minutes after injection my numbness significantly intensified and I had contracture of the left hand. I also experienced tingling of the lips, tongue and face. Within a couple minutes my right hand also began to experience contractures. At this same time my heart started racing and i had difficulty breathing (likely hyperventilation due to stress). Once I arrived at the emergency room a ecg was completed. The contractures went away, but re-emerged multiple times. My ionized calcium was found to be low (1.11 mmol/L), but no other notable lab abnormalities. This persisted for a few hours and finally went away.
33 2021-07-12 eye movement disorder Patient came into pharmacy to receive 2nd COVID-19 Vaccine dose. I screened patient and there was no... Read more
Patient came into pharmacy to receive 2nd COVID-19 Vaccine dose. I screened patient and there was no contraindications. Patient mentioned she was dizzy after the first dose and it resolved quickly and gets dizzy with most vaccines and lab-work. Patient stated she ate food and drank a lot of water prior to coming as she had not eaten last time. I recommended patient just stay still in chair for few minutes after administration to avoid dizziness. I administered vaccine at 9:36 am and patient was fine, and verbally speaking for couple minutes and then stated she wanted water and was feeling dizzy and hot. I called the patients husband from the waiting area and at that moment the patients eyes went inwards and it seemed like she was passing out. Patient was conscious, and kept talking but looked very pale and clammy. I dialed 911 and EMT responded after few minutes. Patients blood pressure was 93/67 and pulse was 75 bpm according to EMTs. Patient declined to go to hospital and patient and husband sat in the waiting area for a bit and left pharmacy at 10:30 am.
33 2021-07-13 ringing in ears On initial shot, felt very spacey and out of it , I had to sit down for a while . A few hours after ... Read more
On initial shot, felt very spacey and out of it , I had to sit down for a while . A few hours after felt shortness of breathe . Blurred vision. Was unable to sleep full night , woke up with brain fog , tinnitus ,. Following day terrible brain fog , tinnitus, shortness of breathe even when laying down . Doctor recommended 36 hours later to go to ER. Went to ER- did tons of tests and cat scan of chest and x ray. No negative scans . Discharged me with no remedy , doctor confirmed adverse reaction. On the 4th day today, tinnitus has gotten worse . Mental brain fog worse . Cannot sleep. Do not feel like myself . Feel depressed , like a cloud is following me in my head .cannot remember things . Brain is not processing and functioning normally . Ringing won?t stop. Feel like I am losing my mind . Shortness of breathe is slowly getting better , but still very prevalent .
33 2021-07-17 taste impairment Metal taste in mouth that lasted for about 6 hours.
33 2021-07-17 taste impairment Fever 102; severe arm pain from neck to wrist; fatigue; muscle aches; headache; metal taste; This is... Read more
Fever 102; severe arm pain from neck to wrist; fatigue; muscle aches; headache; metal taste; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: unknown) via an unspecified route of administration in the left arm on 24Mar2021 at 09:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medication were reported as no. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: unknown) via an unspecified route of administration in the left arm on 03Mar2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient reported that there were no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. On 24Mar2021 at 22:00, the patient experienced fever 102, severe arm pain from neck to wrist, fatigue, muscle aches, headache and metal taste. The patients relevant tests included body temperature on 24Mar2021 and the result was 102-degree F. No treatment was received for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of fever 102, severe arm pain from neck to wrist, fatigue, muscle aches, headache and metal taste were resolving at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
33 2021-07-19 taste impairment Muscle pain in arm, neck, upper back on side vaccine was administered; Stomach upset; Mild headache;... Read more
Muscle pain in arm, neck, upper back on side vaccine was administered; Stomach upset; Mild headache; sore throat; fatigue; metal taste in mouth; Feel a bit like the flu but with no fever; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the arm left on 30Mar2021 at 16:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to multiple herbs, spice and some medication (unspecified). Concomitant medications received within 2 weeks of vaccination included hydroxyzine hydrochloride (VISTARIL). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 30Mar2021 at 19:00, the patient experienced muscle pain in arm, neck, upper back on the side of vaccine administered, stomach upset, mild headache, sore throat, fatigue, metal taste in mouth and felt a bit like flu but with no fever. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of muscle pain in arm, neck, upper back on side vaccine was administered, stomach upset, mild headache, sore throat, fatigue, metal taste in mouth and feel a bit like flu was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
33 2021-07-20 smell distorsion 2nd follow up report: Around April 5, I had arthritis all over my body especially my hands. I went t... Read more
2nd follow up report: Around April 5, I had arthritis all over my body especially my hands. I went to the doctor about it and they did an autoimmune test for it and everything came back negative. I have had phantom smells - I smell smoke when there isn't any present. I smell lit very strongly when others don't smell it at all. Smells have changed: whenever I smell urine or feces - it doesn't smell like that it smells like rotting flesh. (I'm a nurse.) I've been having insomnia - can't sleep. If I do go to sleep, I just keep waking up. I'm still having insomnia; I'm getting arthritis every once in a while. It's not gone. My phantom smells are mostly gone but a smell issue is still there. The doctor said to do smell therapy - to smell different essential oils - if I try to smell peppermint, I can't find it. I can't smell tea tree - only has a slight smell and it's not a tea tree smell, it smells like an old attic. Same thing with lavender and orange - they either smell or or not at all. There is no other treatment for the smell thing. My doctor told me to take vitamins for the arthritis. For the insomnia, I take melatonin but that just puts me to sleep. It doesn't keep me asleep. The forgetfulness that I reported in the previous report has improved since then - it hasn't completely gone away but it's improved.
33 2021-07-20 ringing in ears Left ear pulsatile tinnitus; This is a spontaneous report from a contactable consumer, the patient. ... Read more
Left ear pulsatile tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 20Mar2021 at 16:30 (at the age of 33-year-old), as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa drugs. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for unknown indication from an unspecified date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 21Mar2021, the patient experienced left ear pulsatile tinnitus. Therapeutic measures were taken as a result of pulsatile tinnitus and included treatment with steroid therapy - prednisone. This adverse event resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the event left ear pulsatile tinnitus was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
33 2021-07-21 eye twitching eye twitching left side of face paralyzed, dx with Bells Palsy
33 2021-07-22 visual impairment Severe vertigo; Cognitive impairment; Chronic fatigue; Speech issues; Vision difficulties; Numbness ... Read more
Severe vertigo; Cognitive impairment; Chronic fatigue; Speech issues; Vision difficulties; Numbness in face; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot Number: EW0185) via an unspecified route of administration, administered in Arm Left on 11May2021 (Age at vaccination: 33 Years) as dose 2, single for covid-19 immunisation. Medical history included as blood cholesterol increased, gastroesophageal reflux disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. She received historical vaccine bnt162b2 (BNT162B2, Batch/Lot Number: EW0182) via an unspecified route of administration, administered in Arm Left on 2021. She has no allergies. She was no Pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jul2021, The patient experienced severe vertigo, cognitive impairment, chronic fatigue, speech issues, vision difficulties, numbness in face. The patient was hospitalized for severe vertigo, cognitive impairment, chronic fatigue, speech issues, vision difficulties from 2021 to 2021. Presented to ER 2 weeks after 2nd shot. Admitted to hospital overnight. There was 2 days of hospitalization. She has taken Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient underwent lab tests and procedures which included blood test: inconclusive on 2021 All tests inconclusive,computerised tomogram head: inconclusive on 2021 All tests inconclusive , computerised tomogram neck: inconclusive on 2021 All tests inconclusive , magnetic resonance imaging head: inconclusive on 2021 All tests inconclusive. She has taken treatment as Meclizine for vertigo. It was not working. Therapeutic measures were taken as a result of severe vertigo. The outcome of the event (vertigo, cognitive disorder, fatigue, visual impairment, hypaesthesia) was not recovered. Follow-up attempts are completed. No further information is expected.
33 2021-07-25 blindness I had a frozen embryo transfer on 8/31/2020. I received my first dose of Pfizer on 2/12/21 and my se... Read more
I had a frozen embryo transfer on 8/31/2020. I received my first dose of Pfizer on 2/12/21 and my second dose on 3/5/21. I began experiencing swelling in my hands, feet, and face toward the beginning of March. I let my OB know and she decided to do blood work which I had done on 3/15/21. The blood work showed low platelets and high uric acid. My BP was elevated at this point but not overly high. I went into the hospital to be monitored on 3/17/21. My BP was elevated but not enough to be admitted. My protein in my urine was in the single digits. I had another appointment on 3/19/21 and my blood pressure was high. I was told to monitor my BP at home and if I had a reading over 160/90 or a headache to call immediately. On 3/20/21 I had a horrible headache and a high BP reading so I was again told to go to the hospital. At this point my BP was very high so I was admitted to the hospital. I was 31 weeks pregnant at this point. The goal was to get to 34 weeks. The protein in my urine continued to rise into the 10,000s. On 3/22/21, I had a horrible headache while in the hospital and my BP rose into the severe range. It was determined that I developed severe preeclampsia and I had an emergency c-section at 4:30 AM on 3/23/21. My son was born at 31 weeks 6 days and spent 37 days in the NICU. I also developed posterior reversible encephalopathy syndrome and lost some of my vision and had hallucinations. After about a month, my BP and vision were back to normal.
33 2021-07-25 swelling around the eyes, mouth tingling Allergic reaction/swollen face / puffy eyes / numbing of left side / tingling on upper and lower lip... Read more
Allergic reaction/swollen face / puffy eyes / numbing of left side / tingling on upper and lower lips.
33 2021-07-26 loss of taste, loss of smell I am feeling COVID-like symptoms a week after I received the second vaccine. Body aches, chills, sor... Read more
I am feeling COVID-like symptoms a week after I received the second vaccine. Body aches, chills, sore throat, cough, runny nose, loss of taste/smell.
33 2021-07-26 loss of smell I went to Acute Care on 06/21/2021. They tested me for COVID and the test came back negative. I woke... Read more
I went to Acute Care on 06/21/2021. They tested me for COVID and the test came back negative. I woke up on 06/26/2021, I was putting on lotion and I realized that I couldn't smell anything. My boyfriend and my daughter had just been diagnosed with COVID the week prior. I was in quarantine with my family from work. I put Vick's vapor rub under nose and could not smell it. I became very ill after that. I felt like my nerves were being pinched in my joints. I developed a rash on my hands, had headaches, backaches and chest pain. I felt nauseous at times and could hardly eat anything. The only thing that I could taste was the sweetness or bitterness of candy. I felt very tired at times too. I was re-tested for COVID and this time it came back positive. I felt like someone was ripping my muscles apart. It was a terrible pain that I felt.
33 2021-07-26 feeling of choking AFTER ADMINISTRATION DURING OBSERVATION PERIOD, PATIENT INFORMED PHARMCIST OF TINGLING/FUZZY FEELING... Read more
AFTER ADMINISTRATION DURING OBSERVATION PERIOD, PATIENT INFORMED PHARMCIST OF TINGLING/FUZZY FEELING IN THROAT, DIZZINESS, RACING HEART AND CHEST TIGHTNESS. PHARMACIST HAD PATIENT ELEVATE LEGS, GAVE WATER AND LIQUID BENADRYL. PATIENT OBSERVED FOR 10-15 MINUTES WHILE WAITING FOR IMPROVEMENT. PATIENT NEVER LOST CONSCIOUSNESS OR REPORTED TROUBLE BREATHING. PATIENT WAS ABLE TO CALL OWN DOCTOR AND HAVE PRESCRIPTION FOR PREDNISONE CALLED IN WHILE PHARMACIST CONTINUED TO MONITOR PATIENT. SHE WAS ABLE TO LEAVE PHARMACY ON HER OWN ABOUT 30 MINUTES LATER, HUSBAND WAS WITH HER AT THIS TIME. SHE WAS GIVEN BENADRYL AND PREDNISONE FOR AT HOME USE
33 2021-07-27 blindness, double vision, eye movement disorder, eye swelling, bloodshot eyes, vision blurred thought about committing suicide; auto immune disease; having a sinus infection; right eye got real ... Read more
thought about committing suicide; auto immune disease; having a sinus infection; right eye got real swelled; depressed; eyes are like cockeyed; double and blurred vision; migraines; allergy flare up; ANA results with antibodies and they came back abnormal; double vision and seeing black and white; right eye had been red/ right eye wouldn't move and she had redness; right eye wouldn't move; lost vision in right eye from right eye to left eye; Headache; This is a spontaneous report from a contactable consumer. This contactable consumer (patient) reported for herself that a 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 33-years, via unspecified route of administration, administrated in left arm, for COVID-19 immunisation, first dose (lot number: ER8730, expiration date: 31Jul2021) on 29Mar2021 at 11:00 at 0.3 ml single, second dose (lot number: ER8735, expiration date: 30Jul2021) on 19Apr2021 approximately 11:00 at single dose. Medical history included she had allergy issues (normally around this time, when the season is going from hot to cold). No prior vaccinations (within 4 weeks). Concomitant medications were not reported. The patient stated that back in Mar2021 had real bad headache then it got worsen and worsen, then she lost vision in right eye from right eye to left eye and her right eye got real swelled, it went to the other side, she had issues with left eye and went to the doctor that what was going on with her eye and then it went with left eye now after her vision was altered if everything that was left to her came in front of her and now her arm one of the auto immune disease, she was waiting for the doctor to call back for her results but looking over it said she had an auto immune disease. Then stated that had the headache, the loss of vision throughout both of eyes but at different times, was having issues with eyes she did not have regular vision and eyesight anymore, change the direction of her eyes, her eyes were going outwards, then lack of vision in eyes. The patient also mentioned that she got the shot 29Mar2021. From that day, the headaches gradually increased, increased and increased. Starting in Apr2021, she started missing time off work due to the headaches. Did not remember the exact date in Apr2021, it was close to the middle, she started losing vision in her right eye and was having double vision, seeing black and white. In the midst of this, her eye had swollen up real big. Sometime in May, in her right eye, the vision started slowly coming back. It went from the right eye to the left eye. She couldn't see out of the eye. It was double and blurred vision. In Jun2021, the headaches started slowly decreasing. She took some different types of medication to try and get the headaches under control. Her right eye had been red now for about 2 weeks. In the midst of this, back in Apr2021, while at the doctor's, during an eye exam, her left eye would move but the right eye wouldn't move and she had redness. Before the redness in the right eye, she was trying to focus her right eye and it would throw her left eye. Her eyes were like cockeyed. When she looked straight ahead, in front of her, she was looking at her left eye which was off to the side. Her left eye sits in the corner of her left eye. Everything on the left side and with her vision being unbalanced, she did not have regular vision. Everything on the left side sits in front of her on the actual left side. She had lab work done and hadn't gotten the results and they hadn't been clarified by the doctor. She had ANA results with antibodies and they came back abnormal. The eye doctor and neurologist said she had to get another MRI done to figure out why her brain was not working with her eyes. All of this stuff started happening after she got the COVID shot. This had changed her life dramatically and she was depressed. The headaches were so bad, she thought about committing suicide. It was the worst time of her life and she had so much going on, just from getting the shot. She was driving basically blind just to get back and forth to work and home. She may trip and fall at work or have an accident. The person she spoke to previously was being impatient. Her vision was not accurate and it took a second longer than the average person, to wait for her eyes to zoom in and that good stuff. At this point, she wished she did not get it. She hadn't even caught COVID. Now she had this mysterious cockeyed and red eye and can barely see because of the headaches. The patient was given different medications to try and control the headaches, it was a whole lot of medications. They gave her sumatriptan succinate (ZEMBRACE SYMTOUCH) 3mg, which was supposed to help with headaches, verapamil 120mg as treatment for cluster headaches. They gave her allergy pills to take because they thought she was having a sinus infection, levocetirizine 5mg. For treatment of headaches, to treat migraines, they gave her propranolol ER 60mg. They gave her amitriptyline 25mg, which made her very sleepy. It was what the neurologist gave her. The neurologist gave her the following (took these maybe once over 2 days): topiramate 100mg and baclofen 10mg. She also took sumatriptan 50mg and ibuprofen 800mg for headaches. She was not a person who got sick, may have an allergy flare up. The patient underwent lab tests and procedures, which included she was taking MRI of brain on Sunday. On 01Jul2021, they checked her thyroid to make sure there were no issues; they checked ANA, ESR, TSH, T3, T4, antithyroid, peroxidase, antibodies, and states that she could not read the rest of the tests. AE(s) required a visit to emergency room (was when she got the first MRI, it was back in Apr2021 and she was not admitted) and physician office. Outcome of the events lost vision, auto immune disease, headache, eye swelling was not recovered/not resolved; while of remain was unknown. Follow-up attempts are completed. No further information is expected.
33 2021-07-27 lip swelling Woke up and my lips werecompletely swollen, I have had fillersin the past. Very painful experience f... Read more
Woke up and my lips werecompletely swollen, I have had fillersin the past. Very painful experience forme; Fevers; Tons of pain; I was very sick the first night; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 03Apr2021 at 08:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergy to nuts (allergic to cashews and pistachios) and COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fish oil (MANUFACTURER UNKNOWN) and b vitamins (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 16:00, the patient was very sick the first night, fevers with tons of pain. On 05Apr2021, on Monday morning, the patient woke up and lips were completely swollen, the patient had fillers in the past and had a very painful experience. The events resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of events and included treatment with benadryl and steroid. The clinical outcome of the events pain, sickness, swollen lips and fevers were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
33 2021-07-27 oropharyngeal discomfort I experienced a tight feeling in my face and neck; I experienced a tight feeling in my face and neck... Read more
I experienced a tight feeling in my face and neck; I experienced a tight feeling in my face and neck; my throat and face were itching; My throat and face were itching; Then my throat started to burn and itch; I struggled to swallow; Uncomfortable feeling in my chest; Feel lightheaded; Fell over and sounds around me started to fade away; Uncontrollable arm and leg movements; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 10Jul2021 at 12:30 (at age of 33 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included Ulcerative Colitis, severe seasonal allergies, Chronic Joint pain. Known allergies: Morphine, Peanut, Strawberry, Coconut, Avocado, Latex, Biologic Medication. Concomitant medications included mesalazine (DELZICOL), colecalciferol (VITAMIN D3 1000), origanum minutiflorum oil (OREGANO OIL), Oily Probiotic. On 10Jul2021 at 22:30, the patient experienced a tight feeling in my face and neck and her throat and face were itching. Then throat started to burn and itch, and she struggled to swallow. Had an uncomfortable feeling in chest, then stated to feel lightheaded and fell over and sounds around her started to fade away but didn't completely loose consciousness. Final thing that happened was uncontrollable arm and leg movements. Called and went to the ER. The ER doctor didn't do anything. The patient received Benadryl. The outcome of the events was recovering. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
33 2021-07-27 mouth tingling Left arm, left leg, left groin, left side of neck , face and chin tingling/ pins and needles; lips a... Read more
Left arm, left leg, left groin, left side of neck , face and chin tingling/ pins and needles; lips and under tongue tingling; Neck felt like it was on fire; Painful; This is a spontaneous report from a contactable nurse. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the arm left on 12Mar2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish and avocado. Concomitant medications include prenatal medication, birth control medication, plantago ovata (METAMUCIL), ibuprofen (MOTRIN) and paracetamol (TYLENOL). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021, 30 mins after the vaccine the patient felt left arm, left leg, left groin, left side of neck and the face tingling. Then 45 mins after the vaccine the patient's neck felt like it was on fire. It was reported that the last 24 days (at the time of this report) the patient still had burning, tingling in neck, face, chin, lips and under tongue in mouth. It happened almost every day sometimes twice a day and felt like painful, burns and also felt like pins and needles. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events left arm, left leg, left groin, left side of neck, face, chin, lips and under tongue was tingling, felt like pins and needles, neck felt like it was on fire and painful was recovered with sequelae on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.
34 2021-01-02 mouth itchiness I had an allergic reaction within ten minutes and was taken to the emergency room with throat pain, ... Read more
I had an allergic reaction within ten minutes and was taken to the emergency room with throat pain, itching in the throat and mouth and a swollen uvula. I was given multiple doses of Benadryl and steroids. The next day I developed a temperature of 102 degrees and had a severe headache, nausea, and body aches. The headache and fatigue are still present now 4 days later.
34 2021-01-03 ear discomfort SOB day of vaccination; not critical. Flushing of ears and face roughly 9 hours after vaccination; f... Read more
SOB day of vaccination; not critical. Flushing of ears and face roughly 9 hours after vaccination; followed by fevers 101.0-101.5 overnight. Next day chills, ?feeling of burning from the inside out bilaterally in my lower extremities,occassionally drifting to arms.? Also fatigue.
34 2021-01-03 ringing in ears Flushing; she noticed that there was a ringing in her left ear; Experienced a weird heaviness on her... Read more
Flushing; she noticed that there was a ringing in her left ear; Experienced a weird heaviness on her upper chest and arms/ heavy legs and arms/really heavy arms and legs; experienced a weird heaviness on her upper chest and arms; really cold hands; felt really hot at the injection site/really hot sensation at injection site; lightheadedness/Light-headed; Palpitations; Feeling faint; shortness of breath; Her blood pressure went up to 134/100; paleness; went up to her face; felt tired/She was really tired and slept it off; This is a spontaneous report from a contactable nurse, who is also the patient. This 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) intramuscular in the left deltoid on 20Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included ongoing asthma (diagnosed as a teenager with sports asthma and uses an inhaler). There were no concomitant medications. The patient experienced lightheadedness/light-headed (medically significant) on 20Dec2020 with outcome of recovering, palpitations (medically significant) on 20Dec2020 with outcome of recovered on 20Dec2020, feeling faint (medically significant) on 20Dec2020 with outcome of recovered on 22Dec2020, flushing (medically significant) on 21Dec2020 with outcome of recovered on 22Dec2020, she noticed that there was a ringing in her left ear (medically significant) on 21Dec2020 with outcome of recovering, shortness of breath (medically significant) on 20Dec2020 with outcome of recovering, her blood pressure went up to 134/100 (non-serious) on 20Dec2020 with outcome of recovered on 20Dec2020, she experienced a weird heaviness on her upper chest and arms (non-serious) on 21Dec2020 with outcome of recovering, really cold hands (non-serious) on 21Dec2020 with outcome of not recovered, paleness (non-serious) in Dec2020 with outcome of unknown, felt really hot at the injection site/really hot sensation at injection site (non-serious) on 21Dec2020 with outcome of recovered on 23Dec2020, went up to her face (feeling hot) (non-serious) in Dec2020 with outcome of unknown, heavy legs and arms/really heavy arms and legs (non-serious) on 21Dec2020 with outcome of not recovered and felt tired/she was really tired and slept it off (non-serious) in Dec2020 with outcome of unknown. The patient specified that she experienced a moderate reaction after having the COVID-19 vaccine. She had the vaccine last Sunday morning 20Dec2020. She was told to wait 20 minutes before leaving. In the waiting area, she felt lightheaded, had palpitations and was feeling faint. After 20 minutes she started feeling better. Then she started to have more intense light headedness. She went to the ER and was given oxygen. Her blood pressure was 134/100 on 20Dec2020. She had an EKG on 20Dec2020 that was normal. They gave her steroids and Benadryl. She had another episode while being injected with the steroids. On Monday 21Dec2020, she experienced a weird heaviness of her upper chest and arm. She had really cold hands and flushing. On Monday night 21Dec2020 she went to work. She experienced a really hot sensation to the injection site that went to her neck and face. Her left ear was ringing. This lasted until Tuesday 22Dec2020. She took Benadryl again on Tuesday 22Dec2020. She had shortness of breath which started on 20Dec2020 and on 22Dec2020 she had shortness of breath that lasted until 11am. She had really heavy legs and arms and went back to the ER. She had a chest X-ray and D-dimer on 22Dec2020 that were normal per the ER. The night before the report, she had some of the same symptoms. She was really tired and slept it off. She didn't take anything. The morning of the report, she was feeling good and better. She still has heavy feeling on upper chest and arms. Caller clarifies that she did not have a heavy feeling in her legs. Her arms feel heavy if she holds her phone too long. She continues to have ringing in her ear. The flushing went up to her face. The patient specified that she developed sports asthma as a child and uses an inhaler. She gets short of breath if she overexerts herself. Additional laboratory investigations on 20Dec2020 included blood work with unknown results and Troponin which was normal. She was provided with a general steroid. She did not know the name of it. She was also given Benadryl and monitored on telemetry. She was given IV fluids again on 22Dec2020.; Sender's Comments: Based on the compatible temporal association and the known pattern of response, the Company considers the reported events are possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-05 mouth numbness, mouth tingling Numbness and tingling in roof of mouth, tongue, and lips; no medications given, Transferred to ED f... Read more
Numbness and tingling in roof of mouth, tongue, and lips; no medications given, Transferred to ED for evaluation and further monitoring
34 2021-01-05 mouth numbness Numbness in mouth lasting more than 5 hours now, no musculature involvement
34 2021-01-05 mouth tingling, mouth numbness Numb roof of mouth, tingling tongue and lips; no medications given; patient transferred to ED
34 2021-01-05 mouth tingling heart rate (HR) was 180; tongue and lips tingled; walking for a short distance and felt "off; This i... Read more
heart rate (HR) was 180; tongue and lips tingled; walking for a short distance and felt "off; This is a spontaneous report from a contactable Nurse reported for herself. This 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration on 29Dec2020 15:15 at single dose on left arm for Covid-19 immunisation. Medical history included allergies to hepatitis B vaccine rhbsag (HEY B VACCINE) booster and poison ivy. Concomitant medication included biotin / calcium pantothenate / cyanocobalamin / folic acid / nicotinamide / pyridoxine hydrochloride / riboflavin / thiamine mononitrate (B COMPLEX), fexofenadine, ascorbic acid (VIT C) and Multivitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Immediately after shot (29Dec2020 15:15), her tongue and lips tingled but it went away quickly. She was walking for a short distance and felt "off." The patient checked her pulse and pulse ox and her heart rate (HR) was 180. Her HR had bounced around from 150-180 with minimal exertion and was in the 90s at rest. No treatment received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of not recovered. The events were non-serious.; Sender's Comments: A causal association between BNT162B2 and the event heart rate increased cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
34 2021-01-05 sensitivity to light, extreme sound sensitivity Evening of the 18th I became dizzy and nauseated, worsening the next day. It felt like how I have pa... Read more
Evening of the 18th I became dizzy and nauseated, worsening the next day. It felt like how I have patients describe migraines where noises make them feel dizzy, but I did not get a headache. Movements, lights and noises made the symptoms worsen. I was feeling better by the 21st and now symptoms have resolved.
34 2021-01-05 ringing in ears Since the vaccine I have been having right sided hearing loss. Two days after my first dose I felt l... Read more
Since the vaccine I have been having right sided hearing loss. Two days after my first dose I felt like I was underwater when talking to people, as their speech was distorted. I also felt pressure in my ear, as if it was filled with fluid, and was unable to "pop" my ears. I was evaluated by an ENT and there was no infection or fluid in my ear. It started to get better a little. After my second dose, the symptoms worsen. My hearing loss was back worse than the original time and this time I had tinnitus constantly. I also had chills, fevers, myalgia, back pain, and headaches.
34 2021-01-06 ear pain Chills, fever, full body muscle aches, diarrhea, nausea, headache, sore throat, ear pain
34 2021-01-06 mouth tingling 12/21 VACCINE 11:30. BY 12:30 , TINGLING/NUMBNESS ON L CHEEK BONE. 12/22 I STARTED FEELING MORE NUM... Read more
12/21 VACCINE 11:30. BY 12:30 , TINGLING/NUMBNESS ON L CHEEK BONE. 12/22 I STARTED FEELING MORE NUMBNESS AND PRESSURE ON L CHEEK, TINGLING OF LIPS ON L SIDE, HA ON L SIDE. WENT TO THE ER AROUND 5PM. I TOOK SOME IBUPROFREN, TYLENOL. 12/23 SOMEWHAT RESOLVED FOLLOWING WEEK; SWOLLEN LYMPHNODES ON L SIDE , BACK OF HEAD. COVID TEST; NEGATIVE
34 2021-01-06 taste disorder 1) fever/chills/feverish ~96 h 2) severe myalgia ~36h 3) Chest Pain ~1-2 h 4) SOA ~24 h 5) Altered t... Read more
1) fever/chills/feverish ~96 h 2) severe myalgia ~36h 3) Chest Pain ~1-2 h 4) SOA ~24 h 5) Altered taste ~12h 6) No appetite ~48h 7) Fatigue (couldn't stay out of bed) ~24h 8) Nausea, intermittent ~24h 9) Brain fog ~6h 10) Nasal congestion ~72h 11) Full body COVID like rash with itching on 1/2 ~36h 12) Arm sore/stiff (severe) ~24h 13) Vasovagal episode ~10min
34 2021-01-07 dry mouth increased heart rate, SOB, Tingling, Hot flushed, Red chest, mouth dry
34 2021-01-07 dry throat Transferred to ED. ED documentation below. Initial Vital Signs [01/06/21 1754] Blood Pressure 146/... Read more
Transferred to ED. ED documentation below. Initial Vital Signs [01/06/21 1754] Blood Pressure 146/97 Heart Rate 78 Respiratory Rate 16 Temp 36.9 °C (98.4 °F) Temp src Oral SpO2 97 % 34 y.o. female who arrived by From on-campus presented to the emergency department for an allergic reaction to the Pfizer COVID-19 vaccine. Pt received the first round of injections at 1707 tonight and experienced adverse reactions. Pt endorses dizziness which is accompanied by central abdominal pain and itching of her left thigh. Pt states that her throat is dry, but adds that it could be from not drinking much fluids today. Pt has a hx of anaphylaxis from shellfish and angioedema. She says these current symptoms are not similar to the ones she experienced from anaphylaxis or angioedema. Pt has not started or changed any medications, but had an IUD inserted about a week and a half ago. Pt denies any fevers, chills, coughs, cold symptoms, chest pain, palpitations, shortness of breath, headaches, nausea, vomiting, bowel or bladder problems, or urinary complaints. Clinical exam shows central abdominal pain just above the umbilicus with itching of the posterior aspect of the left lateral thigh. Will administer PO Prednisone and PO Diphenhydramine in the ED and observe the pt. No epinephrine injection was deemed necessary at this time. DDx: allergic reaction 1910 hours: Discussed further treatment and vaccine advice with the pt. Will discharge pt to home. Provided follow up instructions to her PCP, for reevaluation. Discussed return precautions. Vital signs are stable at time of discharge.
34 2021-01-07 ear pain Administered on Saturday January 2, 2021. On Tuesday started with some ear pain and lymph node swel... Read more
Administered on Saturday January 2, 2021. On Tuesday started with some ear pain and lymph node swelling. Wednesday much worse lymph node swelling and right side of face with some swelling. Tingling began and bumps with red line formed on forehead. Thursday-same except swelling I'm lymph nodes was so painful it woke me up. Today, Friday January 8th I went to a doctor's care. Diagnosed with shingles.
34 2021-01-07 ear pain January 06, 2021 ?11:50am shot received Right arm ?21:00 right neck pain ?22:00 right ear pain ?22:... Read more
January 06, 2021 ?11:50am shot received Right arm ?21:00 right neck pain ?22:00 right ear pain ?22:24 right headache and neck pain January 07, 2021 ?07:00 sore throat ?07:00 fatigue, extreme January 8, 2021 ?07:00 fatigue still extreme
34 2021-01-07 eye swelling, eye itchiness, bloodshot eyes AWOKE DAY 2 FOLLOWING VACCINE WITH POSSIBLE ALLERGIC REACTION: THROAT SORENESS/TIGHTNESS AND HOARSE ... Read more
AWOKE DAY 2 FOLLOWING VACCINE WITH POSSIBLE ALLERGIC REACTION: THROAT SORENESS/TIGHTNESS AND HOARSE VOICE, EYES SWOLLEN, ITCHY AND RED. C/O DIFFICULTY BREATHING. DENIED FEVER, CHILLS OR BODY ACHES. MEDICATED WITH BENEDRYL 50 MG AND NO RELIEF. SENT TO ER WITH DIFFICULTY BREATHING.
34 2021-01-07 eye swelling, oropharyngeal discomfort employee awoke with throat tightness/soreness, eye swelling, itching and redness. She reports diffi... Read more
employee awoke with throat tightness/soreness, eye swelling, itching and redness. She reports difficulty breathing and felt like her throat was closing. symptoms are 2 days post vaccination. No fever, chills or body aches. sent was sent to the ER.
34 2021-01-07 mouth swelling Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soren... Read more
Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soreness; hoarse voice; mouth swelling; This is a spontaneous report from a contactable physician, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140), via an unspecified route of administration in the left arm on 18Dec2020 at 15:30 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included severe dust mite allergy (based on skin test). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (MANUFACTURER UNKNOWN), hydrocodone bitartrate/paracetamol (NORCO), ibuprofen (MANUFACTURER UNKNOWN), and ondansetron (ZOFRAN); all for unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 10:00, 6 days post vaccination, the patient experienced anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling; all reported as life threatening. The events led to an emergency room visit and she was given epinephrine (EPI-PEN), methylprednisolone (SOLUMEDROL), and diphenhydramine hydrochloride (BENADRYL) as treatment. The patient stated that she developed the reactions 45 minutes after she took premedications for a dilatation and curettage procedure. The premedications included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron. She stated she had taken these medications several times before and this was the first time she had this reaction. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling were recovered on unknown dates.; Sender's Comments: Anaphylactic reactions presented as chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling, developed 45 minutes after premedications including included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron for a dilatation and curettage procedure and 6 days post vaccination with BNT162B2, the event therefore is most likely attributed to these premedications unrelated to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-07 mouth tingling, oropharyngeal discomfort, mouth numbness about 5-10 minutes after administration, my lips began to move and shake uncontrollably and became t... Read more
about 5-10 minutes after administration, my lips began to move and shake uncontrollably and became tingling and a bit numb. Soon right after my heart rate was very fast, highest 160's. My throat felt weird but I never had any difficulty swallowing or breathing and my mouth, lips, or tongue never became swollen.
34 2021-01-07 mouth tingling, visual impairment Near syncope; lightheaded/dizzy; vision narrow; Tingling in lips; This is a spontaneous report from ... Read more
Near syncope; lightheaded/dizzy; vision narrow; Tingling in lips; This is a spontaneous report from a contactable physician. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via an unspecified route of administration on 20Dec2020 09:00 in left arm at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced near syncope, lightheaded, dizzy, vision narrow and tingling in lips on 20Dec2020 09:30 AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment given to the patient for the events. The outcome of the events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
34 2021-01-07 mouth tingling Paresthesia in lips, hands and feet 15 mins to 3 hours post vaccine Narrative:
34 2021-01-08 eye itchiness Developed rash on back and chest/stomach approx 19 hours after injection . Itchy all over Eye itch... Read more
Developed rash on back and chest/stomach approx 19 hours after injection . Itchy all over Eye itchiness developed 4 hrs after injection Other symptoms were Muscle and body aches Slight cough Sore throat Face puffy Fatigue Chest heaviness (o2 levels stayed 100 percent )
34 2021-01-08 mouth numbness At around 11:45pm tingling started in my left eyebrow. I thought there was something in my eyebrow a... Read more
At around 11:45pm tingling started in my left eyebrow. I thought there was something in my eyebrow and after time of wiping it a few times I went to look into the mirror and realized that nothing was there. about and hour later I got a drink and a snack to eat and I realized I had a numb sensation in the left corner of my lip. As a nurse I went though the signs of a stroke with 2 other nurses I called. Everything was normal other than that sensation. Thinking I was just overly tired I went to bed. When I woke up the next day I felt okay until I went to drink some coffee and the numb sensation in my corner lip was still there. Now I was concerned and called employee health and was instructed to go to the ER to role out a stoke. I followed employee health's instructions and went to the ER. I was diagnosed with facial paresthesia and discharged with instructions to come back if symptoms got worse. Symptoms persisted all day and around 7 I called my mom on video chat to show a visual facial twitch on the left side of my face. right after I got off the phone with her the left side of my face drooped and my fiance immediately drove me to the closest ER. I was seen immediately and they decided to admit me. The did labs and head CT. They admitted me to labor and delivery because there were no other rooms. The next day I was seen by a neurologist and many doctors.
34 2021-01-09 ringing in ears 1/8/21. Second Pfizer dose. Immediately felt soreness in the arm radiating to the neck. Possible fro... Read more
1/8/21. Second Pfizer dose. Immediately felt soreness in the arm radiating to the neck. Possible from technique vs actual vaccine 1807 - Neck pain, 3/10, left arm pain 3/10. Left cervical lymph node inflamed 2035 - ringing on right ear 2244 - dizziness 1/9/21. Injection site 1cm diameter bump. Pain in left arm, neck, shoulder 1156 - headache, sharp right parietal 3/10 1730 - pain 8/10 on left upper arm, radiating to lower arm, shoulder, neck. Improved to 4/10 after Advil 800mg once. 1/10/21. Woke up with pain in left arm 7/10. Injection site has induration of 4cm, reddened, warm, tender to touch. Pain improved after Advil 800mg and Tylenol 500mg
34 2021-01-10 oropharyngeal discomfort About 10 minutes after vaccination, patient stated her left arm and fingers started burning and feel... Read more
About 10 minutes after vaccination, patient stated her left arm and fingers started burning and feeling warm. Burning sensation followed up to left side of face. Second dose of injection given on left side. Patient states she has a scratchy throat. Vitals taken at 1311: 98.9, 152/98, HR 80, 99% on room air. 50mg IM Benadryl given at 1312 in right deltoid. Laid patient down on stretcher. Patient also stated she developed cold like symptoms after her first Covid vaccine injection, and tested negative for Covid. Vitals rechecked again at 1322: 130/86, 99% on room air, pulse 75. Told patient to say for another 15 minutes in waiting room. Patient left at 1345. Patient stated the burning and warmness had gone away.
34 2021-01-11 mouth numbness 40 minutes after the vaccine administration, I experienced numbness on the right side of my face. A... Read more
40 minutes after the vaccine administration, I experienced numbness on the right side of my face. Around my eye, to the side of my nose and around my mouth, only on the right side. Also on the right side of my tongue. This resolved after an hour and a half. It reoccurred about 6 hours later, at 4:00 p.m. . And continued for 48 hours. 12 hours post vaccine, a fever as high as 102 degrees Fahrenheit, severe body aches targeting especially the lower extremities, and chills occurred. The fever and chills lasted 24 hours. The body ach es lasted 48 hours.
34 2021-01-11 fluid in middle ear, deafness unilateral, ear discomfort, ringing in ears feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Sore... Read more
feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy. Concomitant medications included fluticasone propionate for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
34 2021-01-11 mouth itchiness I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itchi... Read more
I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration into the left arm on 30Dec2020 at 11:00 as single dose for an unspecified indication. Medical history included penicillin allergy, sulfa allergy and allergy to nuts from an unspecified date. There were no concomitant medications. The patient experienced allergic reaction, throat pain, swollen uvula, itching in mouth and throat and shaking that was reported as "had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula" on 30Dec2020, at 11:15. The events were reported to have resulted in emergency room/department or urgent care. The events were reported as non-serious. Therapeutic measures were taken as a result of the events: treatment included antihistamine and steroids. Prior to vaccination, the patient had not diagnosed with COVID-19, not had she been tested for COVID-19 since the vaccination. The outcome of events was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
34 2021-01-11 oropharyngeal discomfort, mouth numbness 3 minutes after receiving 1st dose Covid vaccine experienced paresthesias of lips and oropharynx tha... Read more
3 minutes after receiving 1st dose Covid vaccine experienced paresthesias of lips and oropharynx that self-resolved within 5-10 minutes. Also developed paresthesias of bilateral hands and feet with stomach discomfort.
34 2021-01-11 mouth tingling, lip swelling After vaccination patient started complaining of itchy throat. She then stated she was dizzy and th... Read more
After vaccination patient started complaining of itchy throat. She then stated she was dizzy and that there was a lump in her throat. A few minutes after that she stated it was hard to swallow. She also complained about tingling around her lips and had some swelling of her lips. Pt was then given epinephrine and taken to the emergency room.
34 2021-01-11 mouth tingling Patient received vaccine at 5 pm and began noticing reaction symptoms at 5:05 pm. Patient reported f... Read more
Patient received vaccine at 5 pm and began noticing reaction symptoms at 5:05 pm. Patient reported feeling tightness in her throat that went to the back of her tongue and her lips felt tingly. Patient reported that all symptoms quickly went away. Patient stayed for 30 minute observation and once complete, patient denied any further or new reaction symptoms. Patient left observation on her own. No medication were given.
34 2021-01-11 ringing in ears, deafness constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine ... Read more
constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine administered; hearing loss that worsened from before; hearing loss that worsened from before; This is a spontaneous report from a contactable physician (patient). This 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH9899), via an unspecified route of administration, on 04Jan2021 at 08:00AM at single dose for COVID-19 immunisation. The first dose was received on 16Dec2020 at 7:40 AM at single dose. Vaccine location was in the left arm. The patient was vaccinated at hospital, age at vaccination was 34-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included ongoing fluticasone proprionate (FLONASE) for seasonal allergy taking for two years. On 17Dec2020, COVID-19 PCR test was negative. On 04Jan2021 at night, she experienced myalgia, fever, chills, back pain and started with a constant ringing in her right ear and the hearing loss that worsened from before (started on 18Dec2020 after first dose, see AER # 2021012126). Start date of constant ringing in right ear was 05Jan2021. The events resulted in Physician Office visit. Hearing loss in right ear worsened and constant ringing in right ear were reported serious as medically significant while the other events were reported as non-serious. She went to see an ENT doctor and get a hearing test. The hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She is currently being treated with 80mg of Prednisone daily by mouth and getting dexamethasone injections to her middle eardrum. All of these effects have resolved except the hearing loss and ringing in her ear. All the events were considered related to the vaccine per reporter.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
34 2021-01-11 tongue itchiness, swollen tongue -0715 vaccine administered. -0735 started to feel dizzy/off and right side of tongue felt like it wa... Read more
-0715 vaccine administered. -0735 started to feel dizzy/off and right side of tongue felt like it was mildly swelling and itchy. -0735 asked to have blood pressure taken as know when I am having anaphylaxis my blood pressure escalates. -0740 took blood pressure and it was 141/86 in right arm. Normal is 110s/60s-70s. No anxiety feelings. -0740 throat started to have increased mucous production. Had the tickle and tightness in throat. Asked and received 25mg Benadryl with cup of water. -0742 started clearing throat frequently and slight cough. Knew it was anaphylaxis and told the team I need to go to the ER. Asked for additional 25mg Benadryl. Also took 20mg Famotidine and 2 puffs Albuterol inhaler--this is my prescribed anaphylaxis routine. Had Epipens on standby. -0743 put on O2 saturation monitor and watched O2 drop into 90-92 range. Asked for epipen on standby as I know when I need to start it. Didn't want to take that when I knew I was about to get it in the ER and knowing self hadn't progressed that far. Felt chest tightness and shortness of breath. Voice started becoming hoarse. -0800 EMS arrived (delay as team didn't know if they were supposed to call 911 or a Code--they chose EMS even though in hospital). Then staff at COVID vaccine clinic kept emphasizing need to go in ambulance while EMS and self fought to go through hospital (much quicker route). Finally cleared to go through hospital to ER. To get some air via breathing in had to sit up leaning forward. Voice completely hoarse by this time. -About 0817 arrived to ER bay. At this time, frequently coughing and cough started to sound stridorous. Difficulty getting breaths in. Had chest pain near heart. Greeted by MD, 2 RNS, and technician. -0819 received IM epinephrine. Attached to 5 lead EKG monitoring and O2 monitoring. Blood pressure done again. Higher than previous. -About 0821 had working IV (previous two attempts failed as veins were constricting). Given IV Solumderol. Started bolus of 1L Normal Saline. -Not sure how long after by cough subsided, increased mucous production subsided, as well as hoarseness decreased. -Held for observation for 2hours (would be longer if not resolved). - Discharged around 1015. At this time, hoarseness almost all gone. Minimal throat clearing. Cough resolved. -Prescribed epipen inhalers (mine expired) and Prednisone. Prednisone is PRN for mild breathing difficulties if it starts again tomorrow 1/13/21. -At 1400 took 50mg Benadryl and 20mg Famotidine as previously prescribed for anaphylaxis maintenance. Will continue this as previously prescribed every 6hours until symptoms stay resolved. -Made follow up appointment with Primary Care Physician per protocol
34 2021-01-11 vision blurred I had dizziness/lightheaded 10 minutes after dose. Dizziness went away 40 minutes later. 24 hours af... Read more
I had dizziness/lightheaded 10 minutes after dose. Dizziness went away 40 minutes later. 24 hours after dose had body aches. 2 days after dose I had blurred vision in Rt eye and then noticed that Rt eye was fully dilated and Lt eye was normal. Rt eye not responding to light. Went to ED and had 2 CT scans that were normal. They sent me where I had a third CT scan which was normal. I saw ophthalmology and my optic nerve was normal and eyes looked good, but Rt eye still didn't react to light. they ruled out pharmacological and said that it is something neurological. They still don't know exactly what is going on. While at the hospital, I started having urinary retention and now have a foley placed. I have follow ups with neurology, urology and ophthalmology and have orders for MRI of brain and neck.
34 2021-01-12 loss of smell, ear discomfort, loss of taste, taste impairment Patient reports to clinic after receiving the COVID-19 Vaccine at today. Patient states that she was... Read more
Patient reports to clinic after receiving the COVID-19 Vaccine at today. Patient states that she was given the vaccine at 0915 today and about 5 mins after started to have symptoms of a hot sensation from head to toe, heart racing, ears burning, and chest tightness, no breathing difficulty. Patient notified staff and was given O2 and allowed to drink her water. Her symptoms did improve and she was sent to the waiting area again. After about 10 mins her chest tightness came back. Patient states she can feel her blood flowing, "kinda like when your limb is numb". Patient also had symptoms of chills, body shakes, loss of smell, and a metallic taste in mouth. Patient states that she was seen again by staff and laid on a cot for 20 mins, and was then cleared to head back to work around 1000. Patient was seen in the clinic at 1157, and her symptoms since it started have improved. Currently she has the following symptoms: can't taste/smell, (L) arm is sore, H/A, with constant ache, localized to back of neck up to behind the both eyes. Body feels worn out, everything feels heavy, takes a few second to focus when she looks around "like there is a delay". Patient was sent home to recover and to let medical staff know if her symptoms return.
34 2021-01-12 double vision Post shot: 1/11/21 10pm I had a headache and mild chills 1/12/21 12am-2am chills and rigors without... Read more
Post shot: 1/11/21 10pm I had a headache and mild chills 1/12/21 12am-2am chills and rigors without fever 2am-6am fever, chills with rigors at time, nausea, headache, joint pain, fatigue, dizziness, double vision, drenching night sweats 6am-11pm continuing mild fevers and chills without rigors , joint pain, nausea, headache. Last fever was approx 6pm that day but the chills continued 1/13/21 12am-6am chills and fatigue. No fevers. Drenching night sweats 6am- present fatigue and slight headache Motrin was able to help the fevers and I stay well hydrated
34 2021-01-12 dry mouth Pfizer Vaccine; Cough, SOB, uvula swelling, tachycardic, hot flashes, facial tingling and itching, "... Read more
Pfizer Vaccine; Cough, SOB, uvula swelling, tachycardic, hot flashes, facial tingling and itching, "cotton ball" in back of throat, dry mouth; administered Epinephrine 0.3 mg IM x3, solumedrol 125 mg, diphenydramine IV 50 mg and 25 mg, famotidine 20 mg, racemic epi, ativan; reaction started 5 min after dose; discharged with epi pen and prednisone
34 2021-01-12 taste impairment All of these symptoms began on 1/13/21: Chills, headache, fever (100.2-101.0 deg F), nausea, body ac... Read more
All of these symptoms began on 1/13/21: Chills, headache, fever (100.2-101.0 deg F), nausea, body aches, chest pressure, metal taste in my mouth, fatigue
34 2021-01-12 mouth numbness I had the vaccine at 12:23 PM and felt fine. At 2 am that same night I woke up sweating and my left ... Read more
I had the vaccine at 12:23 PM and felt fine. At 2 am that same night I woke up sweating and my left side of my face was numb and tingling. I am able to move it but is continuing to tingle only on my left side. My lips, the very side of my tongue, my bottom jaw and my check bone constantly tingle and feel numb, when I talk some spit comes out on that side and my side of my nose also feels numb. As time goes on it isn't getting any better but not much worse. today my bottom lip just feels more numb
34 2021-01-12 oropharyngeal discomfort Throat felt "fuzzy" and slightly swollen approximately 10 minutes post vaccination, seen in ED, give... Read more
Throat felt "fuzzy" and slightly swollen approximately 10 minutes post vaccination, seen in ED, given benadryl, IV, famotidine, ondansetron, metylprednisolone and discharged to home
34 2021-01-12 mouth tingling Pfizer-BioNTech COVID-19 Vaccine 5 minutes after receiving vaccine she experienced the following sy... Read more
Pfizer-BioNTech COVID-19 Vaccine 5 minutes after receiving vaccine she experienced the following symptoms: rash/hives (rash on chest, back, around hair line, injection site and behind ears), dizziness, numbness and tingling of tongue. Pt taken to ER as rash and tingling of tongue is persisting after taking Benadryl 50 mg and zyrtec 10mg at 0920. Epipen provided at discharge from ED.
34 2021-01-12 swollen tongue Patient reported tongue swelling approximately 2 hours following vaccination with the COVID immuniza... Read more
Patient reported tongue swelling approximately 2 hours following vaccination with the COVID immunization. Patient is a health care provider/ surgeon and managed her symptoms at home. Reported reaction to her assigned PCP.
34 2021-01-13 blindness, ringing in ears Hypotension 91/71 with orthostatic hypotension <80 SBP ( my BP cuff doesn?t read lower than that). N... Read more
Hypotension 91/71 with orthostatic hypotension <80 SBP ( my BP cuff doesn?t read lower than that). Near syncope at 0615. Loss of vision, tinnitus, lowered to the ground and followed by nausea and sweating. Resolved in minutes. Continue to be dizzy today with clammy and dizzy upon standing
34 2021-01-13 eye swelling, drooping eyelid Left eye swollen, and droopy.; Left eye swollen, and droopy.; This is a spontaneous report from a no... Read more
Left eye swollen, and droopy.; Left eye swollen, and droopy.; This is a spontaneous report from a non-contactable other healthcare professional. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 02L20A), via an unspecified route of administration on her left arm on 26Dec2020 at 17:30 at a single dose for immunization. Medical history included penicillin (PCN) allergy. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included phentermine which was received within 2 weeks of vaccination. The patient experienced left eye swollen, and droopy on 08Jan2021 at 04:00. The patient did not receive treatment for the adverse events. Outcome of the events was not recovered. No follow up attempts are possible. No further information is expected.
34 2021-01-13 mouth tingling, feeling of choking, mouth numbness Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.... Read more
Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Sunday had emergency appendectomy for actuate appendicitis.; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Post surgery had allergic reaction unknown reason with head to toe rash; Post surgery had allergic reaction unknown reason with head to toe rash; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular (lot number: EL1283) on left arm on 08Jan2021 at 6:30 AM at single dose for covid-19 immunisation. The relevant medical history included celiac, anemia, known allergies: Sulfa and Gluten. Concomitant medications were not reported. The patient received first dose of BNT162B2 via intramuscular (lot number: Ek5730) on left leg on 18Dec2020 at 11:00 AM at single dose for covid-19 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat. On Saturday the patient had sweating, chills, headache, nausea. On Sunday had emergency appendectomy for actuate appendicitis. Post surgery had allergic reaction unknown reason with head to toe rash. It was also reported that the adverse event started on 08Jan2021 at 03: 15 PM (as reported). The patient had 1-day hospitalization. The patient received treatment for the events. The adverse events resulted in Emergency room/department or urgent care. The events were reported as serious due to life threatening and hospitalization. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. Medications administered during appendectomy may confound reactions experienced post-surgery. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
34 2021-01-14 loss of taste, loss of smell 12/22 evening I had severe arm soreness and light body aches, the next morning I felt congestion, ru... Read more
12/22 evening I had severe arm soreness and light body aches, the next morning I felt congestion, runny nose , severe headache, mild palpitations, my whole body hurt. 12/24 I couldn't breathe through my nose at all , no taste or smell for 24 hours, 1 week after I wasn't getting better my lungs sounded junky , 12/31 I went to the urgent care, I got tested and was negative, I had pneumonia , I was sent home with antibiotic, steroids, inhaler.
34 2021-01-14 lip swelling Hives began 3:30; facial, hand and lip swelling began 4am
34 2021-01-14 mouth tingling Reaction started 40min after injection. It started with tingling above the lips and then numbness o... Read more
Reaction started 40min after injection. It started with tingling above the lips and then numbness on the whole face + redness on face and neck per coworker, then collapsed trying to go to the bathroom to look at the redness, then had generalized weakness for about 45 minutes (couldn't move at all or open mouth and eyes). I was finally able to open my eyes 1 hour after it started. Got discharged 2 hours after symptoms resolution. No medication was needed, symptoms gradually faded away.
34 2021-01-14 tunnel vision tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My ... Read more
tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My hands became cold and numb; fatigue; sore arm, leg/thigh aching; sniffles; sore throat; brief dry cough; slight headache; neck ache; This is a spontaneous report from a contactable Nurse (patient). A 34-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included Mild ADHD/ADD. The patient's concomitant medications were not reported. Approximately 5 minutes after receiving vaccination, she was standing in the observation room (where they had all of them stay for at least 15 minutes to ensure no severe reactions) and experienced a sudden onset of vertigo, tunnel vision and pre-syncope. Her hands became cold and numb and she was trying to talk to another staff member who was arranging/scheduling her second vaccination dose at the same time when this event occurred, but it subsided quickly and she started to feel normal again. All these events occurred at 12:45 on 05Jan2021. She reported this event right away and they had her stay in the room longer. She was stable at that point but experienced these symptoms again but very mildly twice more while she walked back to her car to go home. Other side effects on 05Jan2021 that started in the evening and for the following 2-3 days included fatigue, sore arm, leg/thigh aching, sniffles/sore throat, brief dry cough and slight headache/neck ache. Very mild and tolerable symptoms. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of all events was resolved in Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-15 drooling, pain in jaw, toothache I received my first dose of the Pfizer COVID vaccine at approximately 9:15am on Thursday, January 14... Read more
I received my first dose of the Pfizer COVID vaccine at approximately 9:15am on Thursday, January 14, 2021 in my right arm. Almost immediately, I felt a pain go down to my wrist and across my chest. We pulled into the waiting area and around five minutes after the injection the right side of my face went numb., the pain had left my arm and chest by the time. The nurse reacted by calling the emergency room and sending me there.
34 2021-01-16 mouth tingling 1pm approx. 10 min post vax given, some tingly tongue. Some anxiety 1:10 Gave Zyrtec 10mg 1:13 pul... Read more
1pm approx. 10 min post vax given, some tingly tongue. Some anxiety 1:10 Gave Zyrtec 10mg 1:13 pulseox 98, bp 138/71, pulse 98, some anxiety noted; Gave Benadryl 25mg per patient request 1:23 Tongue tingly gone, 1:40, she felt fine and she went back to work ; Discussed calling MD prior to next vaccine and consider an allergist
34 2021-01-16 mouth tingling Tingling lips, hands and feet for an hour after vaccine shot. It did not start right away, but short... Read more
Tingling lips, hands and feet for an hour after vaccine shot. It did not start right away, but shortly after I left Vaccination site. After about an hour my lips were tingly for the rest of the day until halfway through the next day. I still feel little twinges of tingling in my lips here and there. The sensation does not last long about a minute and goes away.
34 2021-01-17 eye swelling Pfizer vaccine. Around 6pm the following day, left eye swelling noted. Did not decrease in swelling ... Read more
Pfizer vaccine. Around 6pm the following day, left eye swelling noted. Did not decrease in swelling until next day (after 4 doses of antihistamines).
34 2021-01-17 lip swelling The nurse that gave the injection said immediately after injecting the medication the patient became... Read more
The nurse that gave the injection said immediately after injecting the medication the patient became anxious, short of breath, stated that her throat felt like it was closing and became red from the face down in all exposed skin that they could see. They called a rapid response and the patient was given epinephrine from an EpiPen. She also took 50 milligrams of Benadryl p.o.. She then was transferred to the emergency department for further evaluation. Upon arrival to the emergency department patient does not have recall of the events just after the injection, she states that she feels that her upper lip is swollen, her throat is swollen and she is short of breath. She seems very anxious and jittery from the epinephrine. Nursing reports that at the scene she was unable to talk, in the Emergency Department she is able to answer questions and speak full sentences. She states that she feels somewhat better on arrival however is not back to baseline.
34 2021-01-17 feeling of choking, mouth tingling Minutes after receiving 2nd vaccine, patient felt her heart racing and chest tightness. She stated ... Read more
Minutes after receiving 2nd vaccine, patient felt her heart racing and chest tightness. She stated the back of tongue felt like it was tingling. Vitals at 0808: 98%RA, 110 HR, BP 145/80, RR 20. PO Benadryl 25 mg was given at 0811. Vitals rechecked at 0813: HR 75, BP: 124/78, 98% RA, RR 18. Patient states her chest tightness had lessened, but still reported the tingling in her throat and tongue. Stayed with patient and gave her water. Vitals at 0818: 100% O2, HR 73, RR 18. Patient stated at that time she is doing well. Reports that she is working from home today. Told patient to take Benadryl at home if symptoms still present . Last vitals, 0823: HR 75, RR 16, 02 sat 99. At this time, patient stated she was ok to leave and feeling better. Chest tightness subsided.
34 2021-01-17 vision blurred 1st day: sore injection site, diffuse joint and bodily pains 2nd day: symptoms from first day conti... Read more
1st day: sore injection site, diffuse joint and bodily pains 2nd day: symptoms from first day continued as well as nausea, fatigue, malaise, fever, chills, blurred vision 3rd day: symptom severity decreased, blurred vision present then resolved. By the fourth day, symptoms resolved.
34 2021-01-18 vision blurred Her firs was on 12/24 and she reports 7 hours later she had blurry vision and passed out. She conti... Read more
Her firs was on 12/24 and she reports 7 hours later she had blurry vision and passed out. She continued to have nausea and couldn?t eat missed several days of work and lost 5 kg due to nausea. She received the second on 1/24 and she reports that 3 ½ hours later her heart rate was high, blurry vision and soa. She reports she does not remember much other than resting and her husband picking her up. She stated that she couldn?t remember much after that and was difficult to wake up by her family. Was off work a few days and is now back but feeling weak.
34 2021-01-18 vision blurred Her firs was on 12/24 and she reports 7 hours later she had blurry vision and passed out. She conti... Read more
Her firs was on 12/24 and she reports 7 hours later she had blurry vision and passed out. She continued to have nausea and couldn?t eat missed several days of work and lost 5 kg due to nausea. She received the second on 1/24 and she reports that 3 ½ hours later her heart rate was high, blurry vision and soa. She reports she does not remember much other than resting and her husband picking her up. She stated that she couldn?t remember much after that and was difficult to wake up by her family. Was off work a few days and is now back but feeling weak.
34 2021-01-19 deafness unilateral, ringing in ears Tinnitus, hearing loss in left ear started on 12/31/2020 and has not resolved. Vertigo and vomiting... Read more
Tinnitus, hearing loss in left ear started on 12/31/2020 and has not resolved. Vertigo and vomiting started on 1/12/2020 with a duration of approximately 48 hours then resolved.
34 2021-01-19 taste impairment Fever of 103 C, chills, body ache, severe headache, nausea, metallic taste in the mouth 2nd dose of ... Read more
Fever of 103 C, chills, body ache, severe headache, nausea, metallic taste in the mouth 2nd dose of vaccination given at 11 am 1/14/2021. Pain at the injection site . Then body ache started. Midnight 1/14/2021 - chills started, fever 103, severe headache- Fever, body ache and headache continued till Monday(1/18/2021) Strong Metallic taste in the mouth, nausea, dizziness- still continuing.
34 2021-01-19 hearing loss, deafness Tinnitus started in right ear within hour after receiving first vaccination but resolved within a co... Read more
Tinnitus started in right ear within hour after receiving first vaccination but resolved within a couple of day. Within 24 hours of receiving second vaccination had muffled hearing, Jan 3, 2021. Symptoms were ignored thinking they would resolve. When symptoms persisted and evaluated patient was noted to have a severe right sided low frequency hearing loss with poor word recognition score. Patient was started on high dose steroids with partial recovery of symptoms.
34 2021-01-19 tongue disorder Tight and itchy throat, thick tongue- started approximately 5 minutes after vaccine administration a... Read more
Tight and itchy throat, thick tongue- started approximately 5 minutes after vaccine administration and lasted for approximately 4 hours.
34 2021-01-21 ear discomfort, eye itchiness The Patient is a 34 year old female. The patient is a 34 yo female with a history of hypothyroidism... Read more
The Patient is a 34 year old female. The patient is a 34 yo female with a history of hypothyroidism who received Pfizer Covid vaccine on 16 DEC (lot #EK5730) after work. She experienced no immediate adverse effects other than about 5 minutes after vaccine receipt she experienced a sensation of ' blood rushed to my ears.' No dizziness or syncope occurred. She had no oral/face/throat/tongue swelling, no urticaria, pruritis, SOB, Wheezing, dypsnea, cough, CP, n/v/d. The following morning she awoke with pruritus to eyes, face, and urticaria to arms, thighs, chest, face and head. She was treated with 8 mgs of decadron and a dose pack. The symptoms abated. The following morning she experienced recurrence which improved with next steroid dose. She took benadryl that night. Symptoms have continued to recur as steroid wanes.
34 2021-01-21 pupils dilated The day of my 1st vaccine, about 10 min after I was in the waiting room and I started feeling "weird... Read more
The day of my 1st vaccine, about 10 min after I was in the waiting room and I started feeling "weird" in my whole body and lightheaded. I got some juice. Then I started to get hot and was sweating, my whole face and neck were flushed; I also felt mild burning sensation on the R lower lung area. They took me in back and gave me more juice and water and put ice packs on me. It took 30+ minutes to feel better. They called a team to come do my vitals and my HR was in the 100s and they said my eyes were dilated. On my way home I had a weird throbbing pain in my L upper chest just above my boob. When I got home I had chills/felt freezing for a few hours and was fatigued. The next day (Sun) I had moderate joint pain, fatigue, and was very achy; my chest felt tight and I needed my inhaler and some tramadol. On Mon I felt better and went back to work, but then Tues I was achy again and my coworker said I looked pale; I took some tramadol and felt better, just tired. On wed I was having pains in my neck, shoulder, down my arm L arm, and down my scapula- the arm I had the injection. Throughout the day the pain was throbbing and ended up a 7/10 and edema in my neck/shoulder/axillary occurred; I couldnt carry anything heavy and was guarding that arm. Tramadol didn't help the pain and I eventually took 600mg ibuprofen and made a telemedicine visit w/ my MD for the next day. After 3 days the pain was subsiding but the edema took ~ 1 week- it subsided the weekend before my next vaccine. The day of my 2nd dose I did ok after the vaccine at 4pm. While they were injecting it I felt burning down my arm. I felt lightheaded and "weird" afterwards and warm, but no eye dilation or flushing. 3 hours after the vaccine at 7pm I felt tired and a little achy and slept from 7-9pm. At 9pm I woke up very achy, I had 1 itchy hive that popped up on my R inner forearm. The next day I had joint pain in every joint and very achy and fatigued. The joint pain subsided on day 2 after the vaccine but I was very achy and fatigued for a good 72 hrs. Vaccine was wed and saturday the pain in my neck returned and the edema came back and was a little worse than before, and the area where the edema was, was painful to touch. It started subsiding ~ a week after the vaccine, but a little bit is still currently here- but no pain to touch. My allergist has been following up w/ me this whole time.
34 2021-01-23 eye movement disorder COVID-19 vaccination - 2/2 in series. Reportedly, patient fainted following first dose. Approximat... Read more
COVID-19 vaccination - 2/2 in series. Reportedly, patient fainted following first dose. Approximately 5-6 minutes after patient received second dose, she become lethargic, progressing to non-responsive. A rapid response was called and patient was transferred to the emergency department. She was protecting her airway. En route to the ED, patient's eyes rolled backwards and she began having generalized tonic-clonic movement indicative of a seizure. Patient was turned onto her side until seizure activity subsided. Post-ictal state lasted approximately 5-10 minutes after seizure activity ceased and patient became alert and oriented and able to answer all questions. All lab tests and imaging were normal.
34 2021-01-23 mouth tingling, mouth numbness Numb tingly mouth, skin felt like it was burned and hurt for anything to touch it, muscle aches and ... Read more
Numb tingly mouth, skin felt like it was burned and hurt for anything to touch it, muscle aches and spasms, headache, nausea, fever, sore arm
34 2021-01-24 loss of taste, loss of smell COVID symptoms - chills, body aches, fatigue and loss of taste/smell that started on 12/26/2020 (9 d... Read more
COVID symptoms - chills, body aches, fatigue and loss of taste/smell that started on 12/26/2020 (9 days after vaccine). Tested positive for COVID on 12/28. Minor illness, symptoms not severe, recovered quickly, no long lasting effects from COVID that are known at this time
34 2021-01-24 loss of taste, loss of smell Symptoms of COVID that developed on 12/26/2020 (9 days after first dose of vaccine). Had chills, bod... Read more
Symptoms of COVID that developed on 12/26/2020 (9 days after first dose of vaccine). Had chills, body aches, loss of taste and smell. Symptoms fairly minor. Resolved quickly. No long lasting effects
34 2021-01-24 eyelid function disorder, lacrimation increased, taste disorder, mouth numbness, drooling On Thursday 1/21/2021, around 10am: I felt my left lip and mouth had a numbing taste and effect, I w... Read more
On Thursday 1/21/2021, around 10am: I felt my left lip and mouth had a numbing taste and effect, I was slowly throughout the day unable to drink out of a cup without dribbling, my right eye was constantly watering, around 4pm: my right arm started tingling and bothering me, around 9pm: I tasted a Novocain(numbing) like taste in my mouth, I showered and went to bed, while in bed around 10:30pm: I drank out of a water cup and immediately drooled water onto my shirt and my right arm was starting to tingle even more, I thought that was out of the ordinary and got up to look in the mirror, when I looked in the mirror, my first thought was to smile and the right side of my mouth drooped, my right eye was drooping and I was unable to smile or close my eye. At 12:30: I went to the ER for tingling on my face and right arm, I thought I was having a stroke. In between home and traveling to the ER, paralysis started on my right side of face
34 2021-01-24 tongue discomfort Pfizer-BioNTech COVID- 19 Vaccine EUA EMS states "Pt received 1st covid vaccine dose at the clinic. ... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA EMS states "Pt received 1st covid vaccine dose at the clinic. Had an anaphylactic reaction, SOB, throat swelled, abdominal cramps. Received epi injection and 25mg benadryl. BP 150/70. Was tachycardic but HR currently in the 90's." Patient reports similar reaction when she received an allergy shot. ED Physician Note: "She was given her injection and then within about 2 minutes felt palpitations, lightheadedness, whole body numbness, an odd tongue sensation, and stomach cramping. She was given epinephrine and benadryl" Patient was discharged from ED same day with resolution of symptoms.
34 2021-01-25 mouth tingling, mouth numbness had numbness/to her bottom jaw bone/switched between her cheek and jaw and then her nose; face start... Read more
had numbness/to her bottom jaw bone/switched between her cheek and jaw and then her nose; face started tingling/from her lower eyelid/switched between her cheek and jaw and then her nose; face started tingling and had numbness/from her lower eyelid; face started tingling and had numbness/affects her lips/and mouth sometimes; face started tingling and had numbness/affects her lips/and mouth sometimes; It is just very annoying/It is irritating; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3284), via an unspecified route of administration in the left arm on 11Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included ongoing anxiety since she was 13 years old. The patient's concomitant medications were not reported. The patient received the vaccine on Monday at 12 o'clock. She got it for work. She doesn't have a prescribing doctor. She developed the side effect Tuesday at 2 am. The left side of her face started tingling and had numbness, which is the same side she received the vaccine on. She doesn't have weakness. It is not resolving. It is from her lower eyelid to her bottom jaw bone. When asked if it was improving persisting or worsening, she said it depends. Sometimes it gets worse and affects her lips, and sometimes it is on and off. It won't be completely gone. It switched between her cheek and jaw and then her nose and mouth sometimes. If she bends over, it tingles worse. It is just very annoying. It felt like if she had Novocain on the top and bottom of her mouth. It is irritating. She got it because she doesn't want COVID and she works as a nurse. She does have really bad anxiety. She has nothing else medical. She is just really nervous. It is not going away. She is freaking out. She would like more information. The outcome of the event "It is just very annoying/It is irritating" was unknown, while for the other events was not recovered.
34 2021-01-27 eye itchiness On the day of the vaccination in the afternoon I felt very tired and at times I felt dizzy. The nex... Read more
On the day of the vaccination in the afternoon I felt very tired and at times I felt dizzy. The next day I woke up with an intermittent headache, little bit fatigue, very very tired, my arm was super heavy and I was in bed all day. The third day I felt dizzy at times, tired, my eyes itched a lot and my body. I didn't take any medication at any time.
34 2021-01-27 mouth numbness Patient received 2nd dose of COVID vaccine at 1:45 pm, reports noticing symptoms at 2 pm. Patient r... Read more
Patient received 2nd dose of COVID vaccine at 1:45 pm, reports noticing symptoms at 2 pm. Patient reports symptoms similar to when she received 1st dose. Patient reports numbness of lips and roof of mouth. Patient does not want any Benadryl, reports she feels fine otherwise, denies any other symptoms. Patient observed for 30 minutes, after 30 minutes patient reports she feels fine to drive, symptoms have NOT resolved, but patient still feeling OK to leave and drive. Instructed patient if symptoms worsen at any time to return to the ED, patient verbalized understanding. No meds given at this time.
34 2021-01-27 mouth tingling Had a hot flash or flushing sensation; Had a hot flash or flushing sensation; Tingles and a decrease... Read more
Had a hot flash or flushing sensation; Had a hot flash or flushing sensation; Tingles and a decreased sensation around her lips/numbness and a tingling to her lips and nose; Numbness and a tingling to her lips and nose; This is a spontaneous report from a contactable nurse. A 34-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular (left arm) from 14Jan2021 16:30 to 14Jan2021 16:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that 10 minutes after the injection, she had a hot flash or flushing sensation, as well as numbness and a tingling to her lips and nose. She explained having "tingles and a decreased sensation around her lips", which she also referred to as a "diminished sensation" during the interaction. She says that she has done no treatment for this. The outcome of the events was unknown.
34 2021-01-28 inability to speak 12/24 she lost her voice, developed a cough and SOB, developed rash and bruising. She had fatigue... Read more
12/24 she lost her voice, developed a cough and SOB, developed rash and bruising. She had fatigue, muscle and joint pain. 12/26 She developed generalized petechiae.
34 2021-01-28 pain in jaw Tight/sore jaw; Tight/sore jaw; Tingling in cheeks; This is a spontaneous report from a contactable ... Read more
Tight/sore jaw; Tight/sore jaw; Tingling in cheeks; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient (no pregnancy) received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3248), via an unspecified route of administration at site of left arm at 13:15 on 15Jan2021 at single dose for COVID-19 immunization. Medical history included asthma, gastrooesophageal reflux disease (GERD), obesity and known allergies: Sulfa. Concomitant medication included cannabidiol (CBD OIL) and paracetamol (TYLENOL), both received within two weeks of vaccination. The patient experienced tight/sore jaw and tingling in cheeks, both at 13:30 on 15Jan2021. The patient was not pregnant at time of vaccination. Facility type vaccine was in workplace clinic. No other vaccine in four weeks. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of events was recovering.
34 2021-01-28 vision blurred PATIENT REPORTED LIGHT HEADEDNESS, BLURRY PERIPHERAL VISION, AND DIZZINESS.
34 2021-01-29 mouth tingling About 5 minutes after the vaccine, my tongue began tingling. I drank water but didn't tell anyone at... Read more
About 5 minutes after the vaccine, my tongue began tingling. I drank water but didn't tell anyone at the vaccine clinic. I did wait 17 minutes before leaving. I went to the car to look in the mirror and assess my oral airway. My tongue and pharynx were not swollen. I kept drinking water and proceeded to go home. About 10 minutes into my drive my throat became tight, so I went back and checked into the ER. My vitals were stable, and you couldn't see any swelling. My throat felt tight and my tongue tingly. I had already taken pepcid and zyrtec that morning, so they gave me Solumedrol and Benadryl IV. The tingling and tightness improved and went away by about 0930. It did return around 2300 that night (not as bad, just tongue tingly and slight tightening of my throat), and I took another pepcid and benadryl. I also had myalgias, felt febrile and fatigued for about 48 hours. ++See previous VAERS report I did about vaccine #1
34 2021-01-31 sensitivity to light Migraine (2 days now) - started Ibuprofen as needed Light sensitivity (1 day so far) while working ... Read more
Migraine (2 days now) - started Ibuprofen as needed Light sensitivity (1 day so far) while working from home Fatigue Injection site pain (1 day)
34 2021-02-02 lip swelling, ear swelling, eye swelling 0845: generalized weakness, headache, and all over tingling sensation (hard to put into words,) 090... Read more
0845: generalized weakness, headache, and all over tingling sensation (hard to put into words,) 0900: noticed difficulty in swallowing and swelling bilateral side of the neck from top of the ear to bottom of neck. Throat felt slightly tight, not all he way around the esophagus; pressure from the sides. 0902 notified the desk that I was having a reaction 0902 was brought back into triage and vital signs were taken: heart rate in the 70's, blood pressure within normal parameters, oxygen was 100% on room air and respirations were within the normal parameters. The 2 nurses did an focused assessment, no hives or rash, swelling present face ( eye, lips, or face) Just swollen in the neck area. 0905 25mg Benadryl po -liquid was given 0915 vital signs were retaken and vital signs were in the same range as previously mentioned. The nurse asked if I could stay to monitor signs and symptoms. 0930: I felt like the swelling was going down slightly. 0955: Was rechecked by the nurses and was released. Was told to monitor symptoms at home and go to the er if anything should change. **times might slightly vary per what is stated, tried the best to my ability to recall the exact time line
34 2021-02-03 dry eye Very dry eyes, more so than usual. Sometimes I have dry eyes due to contacts but this felt very unus... Read more
Very dry eyes, more so than usual. Sometimes I have dry eyes due to contacts but this felt very unusual. It occurred the next day after receiving Covid vaccine. It only lasted a few hours then went away.
34 2021-02-03 mouth numbness 5 min after shot had flushing, tachycardia and numb lips. 4 days later I developed tachycardia, ches... Read more
5 min after shot had flushing, tachycardia and numb lips. 4 days later I developed tachycardia, chest pain, dyspnea, body aches
34 2021-02-03 mouth numbness Tongue numbness on right side. Mouth feels scalded then moved to feeling like a Novocain injection,... Read more
Tongue numbness on right side. Mouth feels scalded then moved to feeling like a Novocain injection, only one one side. Numbness has moved to middle/back of tongue. Red bumps on tongue.
34 2021-02-04 loss of taste Date of symptom onset: extreme fatigue, body aches, dizziness, lost of taste. Progressed with headac... Read more
Date of symptom onset: extreme fatigue, body aches, dizziness, lost of taste. Progressed with headache throughout the day followed by severe joint pain. Symptoms mostly resolved except for dizziness and loss of taste the next day (today 2/5/21).
34 2021-02-04 ear pain Chills. Fever. Body aches. Ear hurts. Fatigue.
34 2021-02-04 swelling of eyelid Rash on my body started to be observed about 28hrs post my 2nd dose of Pfizer COVID-19 vaccine. Rash... Read more
Rash on my body started to be observed about 28hrs post my 2nd dose of Pfizer COVID-19 vaccine. Rash first appeared in the neck area, then gradually migrated to face and lower back around 10pm. I woke up in the middle of the night feeling itchy in my legs and feet. Rashes on my body disappeared when I woke up today (02/05/2021), but my upper eye lids still felt itchy and swollen. Rashes on my upper eye lids faded in the afternoon on 02/05/2021.
34 2021-02-04 ringing in ears Transient bilateral lower extremity neuropathy; periorbal and facial neuropathy; severe low back pai... Read more
Transient bilateral lower extremity neuropathy; periorbal and facial neuropathy; severe low back pain; tinnitus; This is a spontaneous report from a contactable other health professional (patient) reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3248), intramuscular at left arm on 20Jan2021 at single dose for covid-19 immunization. Medical history was none. No pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 via intramuscular at left arm on 30Dec2020 for covid-19 immunization. Facility where the most recent COVID-19 vaccine administered was nursing home/senior living facility. The patient experienced transient bilateral lower extremity neuropathy, tinnitus, periorbital and facial neuropathy, severe low back pain on 20Jan2021 with outcome of unknown. No treatment was received for the adverse events. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
34 2021-02-05 mouth pain Hives, burning sensation over skin, pain on roof of mouth.
34 2021-02-05 swollen tongue, tongue discomfort, ear pain, mouth numbness Symptoms reported by patient as follows. About 30 to 45 minutes after I received my vaccine The rig... Read more
Symptoms reported by patient as follows. About 30 to 45 minutes after I received my vaccine The right side of my face went numb, my tongue slightly swelled and felt like it was burning. I had pain in my right ear, and body aches. most of my effects were gone after 24 hours. I do still have pain in my right ear, and slight numbness in my face Patient called primary care provider and the below note was documented. Call from patient she received the COVID vaccination and her side of face feels numb and side of tongue and lips. Explained this could be a side effect of the vaccine and if she develops any shortness or trouble breathing she should go to the Emergency room. Patient also states she has been using her incentive spirometer not often but maybe once a day and she feels like her cough is getting deeper. She has had to use her inhalers but is not using them routinely. Patient instructed to use incentive spirometer more often and that this sound normal after surgery. Did offer her a repeat chest xray but patient wishes to hold off on that now. Instructed patient to call with any other concerns. Also if any SOB with vaccine to go to ER
34 2021-02-06 ringing in ears, ear discomfort 13 days after my first Pfizer covid shot, I had sudden onset of tinnitus and sensation of ear fullne... Read more
13 days after my first Pfizer covid shot, I had sudden onset of tinnitus and sensation of ear fullness on the left ear only. This lasted 48 hours and spontaneously resolved. I saw ENT physician on day 15 and had normal audiometry. After second Pfizer shot on 1/21/21, that evening I had about 30 seconds of tinnitus which then resolved. I am pregnant and my due date is 5/27/21. No complications with the pregnancy at this time.
34 2021-02-07 lip swelling Lip swelling, nausea, vomiting
34 2021-02-07 vision blurred Blurry vision, racing heart, dizziness, hot/clammy, chills after being really hot, anxiety all withi... Read more
Blurry vision, racing heart, dizziness, hot/clammy, chills after being really hot, anxiety all within 20 mins from injections. At 7:30 when home, cold, dull ache at base of skull.
34 2021-02-09 smell distorsion Phantom smells have occurred twice. Once smelled nail polish remover and a couple days later smelled... Read more
Phantom smells have occurred twice. Once smelled nail polish remover and a couple days later smelled burnt toast; This is a spontaneous report from a contactable Other-HCP. A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), intramuscular in left arm on 06Jan2021 09:00 at first single dose for COVID-19 immunization. Medical history included was none. No known allergies. No covid prior vaccination. Other medications in two weeks: possibly bupropion, quit near this time. No other vaccine in four weeks. The patient experienced phantom smells have occurred twice. Once smelled nail polish remover and a couple days later smelled burnt toast. Adverse event start date: 21Jan2021. No treatment received for the event. No covid was tested post vaccination. Outcome of the event was unknown.
34 2021-02-11 loss of smell Prior to the first dose , I felt completely healthy. I received the first dose on a Saturday at 9am... Read more
Prior to the first dose , I felt completely healthy. I received the first dose on a Saturday at 9am. Felt fine most of that day other than my arm being sore, which improved with Ibuprofen. The following day, I woke up a little achy, but felt better after taking more Ibuprofen. Around 4-5pm on Sunday afternoon, I started feeling more achy with cold chills (highest temp was 99.5) and congestion. I would take Ibuprofen and Tylenol, which would help. On Monday, congestion continued, but the body aches and cold chills went away. I did feel a little tired, but also did not sleep well due to the congestion. Did not have any other symptoms other than the congestion and actually felt pretty good. I worked from home on Monday to be on the safe side. On Tuesday, I was still having congestion (still no other symptoms) and my work did not want me to return until I got checked by a doctor or get a negative covid test. Went to an urgent care where I was seen by a doctor and tested for covid (rapid test), which came back positive. The only other symptom that developed was loss of smell (but not sure if that was just due to the congestion -- it seemed to come and go. Some things I could smell, some things I couldn't). I did not lose my sense of test. The congestion lasted less than a week. My family quarantined for over 20 days. We tried our best, but it was hard to isolate myself, especially from my younger kids. No one else in the household ever developed any symptoms. Not sure how/where I picked it up at --- We are very careful. The only other people I saw the 2 weeks prior to testing positive were my parents and in laws at Christmas, all of which have been healthy.
34 2021-02-11 eye swelling Nonspecific headache, malaise and swollen eyes after the vaccination. The patient the developed sudd... Read more
Nonspecific headache, malaise and swollen eyes after the vaccination. The patient the developed sudden-onset of difficulty breathing 2 days after the vaccine administration.
34 2021-02-12 tongue itchiness Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1006. Developed flushing tongue itching... Read more
Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1006. Developed flushing tongue itching, local redness on shoulders at 1010. Patient was given Benadryl 25mg po in the clinic and remained for observation. After observation, patient cleared to leave clinic - was instructed to call 911 and go to ED if exhibiting any signs or symptoms of anaphylaxis. Patient was given an extra dose of Benadryl, 25mg to take if needed.
34 2021-02-15 taste impairment ~5-10 min after receiving first dose of Pfizer COVID-19 vaccine, patient started feeling dizzy/light... Read more
~5-10 min after receiving first dose of Pfizer COVID-19 vaccine, patient started feeling dizzy/lightheaded/nauseous/iron metallic taste in mouth but did not pass out; RRT called at 1440 and transported via wheelchair to ER triage for assessment. Patient d/c'ed home alert & oriented x 4 in NAD and ambulating with steady gait.
34 2021-02-18 bloodshot eyes, eye itchiness, eye discomfort I received dose 1 of the Covid 19 vaccine on 1/27/21. On Sunday 1/31/21 I noticed my left eye was i... Read more
I received dose 1 of the Covid 19 vaccine on 1/27/21. On Sunday 1/31/21 I noticed my left eye was itchy, red, and felt like something was stuck inside. A visit to my eye doctor revealed that I had developed a corneal ulcer in my left eye. I am not an eyeglass or contact wearer. I have never had issues with dry eyes. I was put on a regimen of steroids and antibiotic eye drops. Update: Today 2/19 is 1 day post dose 2 of covid19 vaccine. I made a return trip to the eye dr and my right eye is now inflammed and my left eye cornial ulcer is still unhealed despite steroid medication.
34 2021-02-20 enlarged tonsils Pfizer-BioNTech COVID-19 Vaccine EUA Fevers of 101.2 degrees F, on and off starting from 10 hours... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Fevers of 101.2 degrees F, on and off starting from 10 hours after receiving vaccine lasting for 100 hours. Body aches, muscle weakness, severe muscle and joint pain in lumbar spine, SI joint and hips. Making it extremely difficult to move. Headaches. Loss of appetite. Swollen tonsils and lymph nodes- neck and inguinal. Swollen left arm around injecting site. Stiffness and pain in shoulder joint- unable to lift arm more than 40%. Extreme fatigue starting 5 hours after injection lasting 96 hours. Felt like a severe case of influenza.
34 2021-02-21 swollen gums Developed swelling to face, gums, throat-unable to swallow. Denies SOB. Went to urgent care treated ... Read more
Developed swelling to face, gums, throat-unable to swallow. Denies SOB. Went to urgent care treated to Solumendrol and Solumedrol dose pack. Resolved after 3-4 weeks. Now at baseline.
34 2021-02-22 mouth tingling, mouth numbness Numbness and tingling of face and lips that got progressively worse. Throat swelling
34 2021-02-23 loss of taste Loss of taste, specifically coffee. Called doctor, advised by nurse to report to VAERS, awaiting doc... Read more
Loss of taste, specifically coffee. Called doctor, advised by nurse to report to VAERS, awaiting doctor recommendation
34 2021-02-23 lip swelling SOB, Hives, Reddness, Swelling in throat and lips. hoarseness and wheezing
34 2021-02-27 ringing in ears Bilateral rash with vomiting, tinnitus, neck pain and hot flashes
34 2021-02-27 visual field defect About 10 minutes after receiving the vaccine, I had chest discomfort followed by the sensation that ... Read more
About 10 minutes after receiving the vaccine, I had chest discomfort followed by the sensation that there was ice around my heart, under my rib cage. The cold heart sensation lasted for roughly 20-30 minutes. Following the start of the cold heart sensation, I became dizzy, sweaty, lost peripheral vision, had numbness in my fourth and fifth fingers (ring and pinky fingers) in both hands, and vaccination site attendant mentioned my hands looked red. Dizziness and other symptoms lasted about 15-20 minutes. Now that over 24 hours have passed, my chest feels a bit tight when I breathe. Injection site is also sore.
34 2021-03-02 mouth numbness Within 5 minutes of receiving the vaccine my throat became itchy, my sinuses began to swell, a press... Read more
Within 5 minutes of receiving the vaccine my throat became itchy, my sinuses began to swell, a pressure headache began and I became congested. After about 20 minutes my face and lips became numb, my cheeks turned red and hot to the touch, my face started to swell and it felt like my blood pressure dropped, I became dizzy. I took 50mg of Benadryl within 30 minutes of the initial onset of symptoms. All symptoms were gone within an hour of taking the benadryl. Over the next couple hours I experienced discomfort/soreness at the injection site and that tattoo on the same arm as the injection site became raised, hot and itchy. As of 3/3/2021 the only symptom remaining is the soreness at the injection site.
34 2021-03-02 ringing in ears Ringing in both ears - tinnitus!
34 2021-03-03 eyelid function disorder On 2/4 patient recieved 1st dose of COVID vaccination and experienced headache and arm pain. On 2/23... Read more
On 2/4 patient recieved 1st dose of COVID vaccination and experienced headache and arm pain. On 2/23 patient received 2nd dose of COVID vaccination at 12:47 p.m. Noticed headache at base of head and took Ibuprofen for relief. On 2/26 at 1:30 pm patient noticed that her right eye was not closing well. Had to force eye closed. On 2/27 early in the morning patient's eyebrows were not moving and it was still hard to close right eye. Stated that the right side of her face was 'not working'. Presented Emergency Department around 8:30 a.m. with complaints of facial numbness. Full workup led to diagnosis of Bell's Palsy. Initiated Acyclovir and Prednisone and discharged to home.
34 2021-03-03 swollen tongue, mouth tingling Pt in COVID vaccine observation area and reports tingling bilateral extremities, lips and tongue. Pt... Read more
Pt in COVID vaccine observation area and reports tingling bilateral extremities, lips and tongue. Pt reports sensation of tongue swelling. Benadryl 25 mg/10ml given. Progressive tingling/numbness reported with mild dyspnea with mild dizziness. No itching reported. Vitals taken and stable. Emergency response contacted; arrived and completed EKG.
34 2021-03-04 eye swelling, lip swelling First vaccine I could feel the vaccine go into my body and down into my legs. It was a very strange ... Read more
First vaccine I could feel the vaccine go into my body and down into my legs. It was a very strange sensation. I felt very fatigued 30 min after the vaccine but ignored it because it was not normal to have symptoms after the first vaccine. That night i did feel a litlle bit of swelling in my lips that continued into the next day but it was not severe. The muscle aches, joint pain and allodynia the 2nd day were so severe I don't really remember any other symptoms i may have had. I took Benadryl and Tylenol and slept for 2 days straight. After the 1st vaccine I did have shortness of breath for about 3 days post. Then I received the 2nd vaccine, I did not feel it go in this time. About 30 min after the second vaccine I felt very fatigued. About an hour later I started to feel slight swelling in my lips that increased and around 2 1/2 hours my eyes and lips were noticeably swollen and I was flushed. My husband noticed my ears and cheeks were bright red. I felt my heart racing and took my pulse it was around 120. I felt dizzy and like there was a lump in my throat. I requested an appointment via video call from the emergency line. I didn't feel like I was having trouble breathing and stayed calm, my pulse went down to 100 after about 20 min. while waiting for my video call. I spoke to the doctor and they recommended going to the ER. I asked since the pulse went down and it felt like I was slowly reacting, if I could try taking Benadryl and see how I felt. She said that was ok but if I felt any difficulty breathing to go to the ER right away. I took 50 mg of Benadryl and felt better and rested. The next morning lips and eyes were swollen again but a little worse. Difficulty swallowing persisted as well as severe muscle pain, joint pain, and allodynia. The symptoms were worse with 2nd vaccine. Noticed shortness of breath just walking up and down steps. These symptoms lasted a little bit longer. 4 days after the vaccine I noticed the lip swelling was not getting better so I called my PCP. He recommended taking the next 2 days off , rest with benadryl and tylenol. I listened and felt good enough to go into work. It is now 4 weeks since i had the vaccine and i am still experiencing some symptoms that seem to be in relation to after i eat. That includes lip swelling, tightness in the muscles around my throat (feel as if they are strained), stomach burning, indigestion, heartburn. Called PCP again who recommended I see an allergist/immunologist.
34 2021-03-05 mouth tingling Tingling of mouth, sweating, dizziness. BP 134/86 (pulse 85), 98% O2 sat. Given juice. Final BP 128/... Read more
Tingling of mouth, sweating, dizziness. BP 134/86 (pulse 85), 98% O2 sat. Given juice. Final BP 128/82.
34 2021-03-06 lip swelling, mouth tingling Five mins after vaccination, I felt tingling in my face and mouth. 15 mins after, I had numbness & t... Read more
Five mins after vaccination, I felt tingling in my face and mouth. 15 mins after, I had numbness & tingling in mouth and throat. Lips were slightly puffy. I reported to pharmacist on duty.
34 2021-03-07 eye swelling patient called at around 5:15pm on 3/8/21 reporting that she has developed swelling around her right... Read more
patient called at around 5:15pm on 3/8/21 reporting that she has developed swelling around her right eyes after 1:30pm today (3/8). She received the COVID-19 vaccine yesterday around 10:15am. Patient mentioned that she had some headache and injection site soreness and pain after receving the vaccine, but was fine until today when the swelling appears. She reported no pain with her swollen eyes. Suggested patient to reach out to her PCP or see a doctor in the emergency room.
34 2021-03-07 mouth numbness Numbness on her tongue and lips ,anxiety
34 2021-03-09 swelling of eyelid Onset of symptoms 1-2 days after 2nd Pfizer Dose. Presented to ER with fever, myalgia, headache, mil... Read more
Onset of symptoms 1-2 days after 2nd Pfizer Dose. Presented to ER with fever, myalgia, headache, mild thrombocytopenia/leukopenia, elevated hepatic function test. Also noted mild swelling of upper eyelids.
34 2021-03-10 mouth tingling tingling mouth/lips/tongue, flushing, shaky, "feels like a panic attack". Evaluated by EMS-Refused t... Read more
tingling mouth/lips/tongue, flushing, shaky, "feels like a panic attack". Evaluated by EMS-Refused to transport.
34 2021-03-12 visual impairment Woke up at night to go to bathroom, then quickly started feeling like I was about to pass out, very ... Read more
Woke up at night to go to bathroom, then quickly started feeling like I was about to pass out, very weak, had to sit down on the floor to try and wait it out, had trouble seeing, was able to get up finally and find way back to bedroom by touch. With lights on vision was patchy. Was given water & a granola bar and was able to recover within 5 min. Slept fine after that
34 2021-03-13 lip pain, chapped lips, lip dry Lips became extremely dry and chapped/sore
34 2021-03-14 blindness in both eyes Increased BP, right side vision loss
34 2021-03-14 mouth tingling Tingling lower lip; 5-minute duration
34 2021-03-15 ear discomfort Progress Notes APRN (Nurse Practitioner) ? ? Infusion Center Cosign Needed Expand AllCollapse All ... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Infusion Center Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/16/2021 Patient: DOB: Date: 3/16/2021 MRN: Subjective Patient is a 34 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, hives, shortness of breath This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and chest pain, SOA, rash. Pt felt light headed, diaphoretic PMH of vaso vagal syncope. No event with Dose #1 of 2 ALLERGY REVIEW OF SYSTEMS: Patient complains of chills and ear popping Patient denies facial swelling, ear pain and runny nose Previous Reactions: vasovagal syncope Objective Vitals Vitals: 03/16/21 0926 BP: 98/55 Pulse: 68 SpO2: 100% Physical Exam Constitutional: Appearance: She is diaphoretic. Comments: In chair, pale, diaphoretic, hyperventilating HENT: Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are dry. Cardiovascular: Rate and Rhythm: Normal rate. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion. Skin: Capillary Refill: Capillary refill takes less than 2 seconds. Coloration: Skin is pale. Neurological: General: No focal deficit present. Mental Status: She is alert. Motor: No weakness. Psychiatric: Comments: Anxious, hyperventilating. PMH "vasovagal syncope". No issues with Dose #1 of 2. Pt pale, diaphoretic and hyperventilating. Initial BP 98/55-HR 68. Pt provided water, ice pack to base of neck and placed supine BP improved 10 109/68. HR 70. Pt sat 45 degrees x 10", became light headed again. BP 97/60. HR72/min. Returned to supine position, encouraged to eat granola bar. Position change after 45"observation: BP 11/74. HR 74/min. Pt discharged ambulatory without event Assessment/Plan Treatment included: snacks, prolonged observation and slow position changes Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Ddx: Vasovagal response APRN Electronically Signed 3/16/2021 9:28 AM
34 2021-03-15 mouth tingling 34 female with no previous medical history received 2nd dose of Pfizer vaccine in left deltoid. The ... Read more
34 female with no previous medical history received 2nd dose of Pfizer vaccine in left deltoid. The injection itself was unusually painful and after 10 minutes developed "pins and needles" surrounding naval, and then over the course of 4 days (present) the parasthesias/dysesthesia progressed to include bilateral upper and lower extremities. Today, 4 days post injection, started to notice perioral involvement. It is intermittent, migratory and unpleasant if not painful. Most severe symptoms experienced in right calf, right heel and left finger tips. Exacerbated by use/motion/pressure. Has not attempted any therapeutics to avoid masking progression of symptoms. Primary care physician made aware of.
34 2021-03-15 mouth tingling Tingling in tongue, felt like tongue was a bit puffy - 5 minutes in. Lightheaded, dizzy -5-10 minut... Read more
Tingling in tongue, felt like tongue was a bit puffy - 5 minutes in. Lightheaded, dizzy -5-10 minutes in. BP higher than typical for me Given dose of diphenhydramine 50mg and famotidine 40mg and 4oz of juice to stabilize blood glucose (which, by CGM alert, dropped as well).
34 2021-03-15 swollen tongue, mouth numbness, mouth tingling Pfizer biontech covid 19 Swollen tongue., difficulty swallowing, numb/tingling lips
34 2021-03-16 ringing in ears tinnitus
34 2021-03-17 lip swelling Recipient complained of burning in throat, swelling in lips, and "racing" heart with dizziness appro... Read more
Recipient complained of burning in throat, swelling in lips, and "racing" heart with dizziness approximately 30 minutes after vaccine administration. Transported by EMS to emergency department.
34 2021-03-18 blindness transient Severe dizziness, whiting out of vision, lasting more than 4 hours with recurrence the following day... Read more
Severe dizziness, whiting out of vision, lasting more than 4 hours with recurrence the following day.
34 2021-03-18 eye swelling Horrible headache started a few hours after injection with nausea, but backed off by next morning. B... Read more
Horrible headache started a few hours after injection with nausea, but backed off by next morning. By Saturday, the headache was back with the nausea and I began feeling very itchy. When I woke on Sunday, I had hives and a rash all over my face and most of my left side, which is the side I got my shot. Called Dr Monday and was sent to urgent care, who then sent me to the ER. Heart rate was high, hives, rash, headaches, nausea, swollen eyes and face, swollen lymph nodes
34 2021-03-18 mouth tingling 3-18-21 3:09PM 'TIPS OF 4 FINGERS ON RT HAND TINGLE'. NO MOTER OR SENSORY DEFICIT. GOOD CAP REFILL... Read more
3-18-21 3:09PM 'TIPS OF 4 FINGERS ON RT HAND TINGLE'. NO MOTER OR SENSORY DEFICIT. GOOD CAP REFILL. A/O, PINK, W/D, RESP REG WITH EASE. NO ACUTE OR OBVIOUS DISTRESS. 3:11PM AMBULATORY TO EXIT - GAIT BRISK AND STEADY. 3-19-21 9AM: 'TINGLING LASTED SEVERAL HOURS AND TONGUE WAS ALSO TINGLING - BUT NOW IT'S GONE'.
34 2021-03-20 mouth numbness flushed tachycardia; numb lips; chest pain; shortness of breath; chills; aches; This is a spontaneou... Read more
flushed tachycardia; numb lips; chest pain; shortness of breath; chills; aches; This is a spontaneous report from a contactable nurse. The 34-Year old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 (Batch/Lot Number: El3246) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma and seasonal allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 18Jan2021 the patient experienced 5 minutes after injection, flushed tachycardia and numb lips. 3 days later chest pain, shortness of breath, tachycardia, chills, aches. Covid negative. Still not fully resolved. The patient underwent lab tests and procedures which included viral test: negative on 20Jan2021. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as not recovered.
34 2021-03-20 taste disorder Headache; taste was more impacted/ food didn't taste right/ too bitter/taste horrible; very bad migr... Read more
Headache; taste was more impacted/ food didn't taste right/ too bitter/taste horrible; very bad migraines; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot/batch number: unknown), via an unspecified route of administration in left arm on 14Jan2021 at 07:30AM at single dose for COVID-19 immunization in hospital. Medical history included tested positive for COVID-19 on 09Sep2020. She had loss of taste and smell; next day horrible diarrhea; third day she had a headache for two days; then on day four or five she got a slight fever. The whole time starting on day three her heart was racing and she couldn't sleep. States her rapid heart rate was resolved about two weeks before the vaccine. She is still recovering her sense of taste. Mentions she saw a cardiologist and had an echocardiogram that was normal in 2020. She has continued to experience the episodes of resting tachycardia but not so often now. Maybe once every two weeks. Concomitant medications were none. No vaccines were administered on same date of the Pfizer suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 34-year-old on 22Dec2020 at 10:00AM in the left arm for COVID-19 immunization. She had a headache and rapid heart rate that night and was up all night. It seemed like some of her COVID symptoms came back that first night. Added her arm hurt but she felt like that was related to the administration of the shot. Adds that is not how to give a shot. Adds her COVID symptoms had all gone away and then they came back but only for that first night after the first dose. Physical therapist reported that she received part two of the vaccine two weeks ago and ever since then she has had very bad migraines in Jan2021. She felt like she had recovered from the previous vaccine then she noticed her taste was more impacted on 15Jan2021. Her taste and smell was coming back from her COVID infection but after the second dose it seems like food didn't taste right. Mentions she loves Cilantro but now she can't eat it or anything citrus because it seems too bitter and Coke products taste horrible. Now she has a headache that started again on 16Jan2021. Adds normally she doesn't get headaches. She has tried rehydrating, tried drinking water and gatorade but the only thing that is helping is taking ibuprofen or Tylenol. She is rotating taking these products every other day and it is helping. Headaches come back when the medication has worn off. Patient does not require a visit to physician or ER for events. The outcome of events migraines, taste was more impacted was not recovered; unknown for another event. Information about lot/batch number has been requested.
34 2021-03-21 eye disorder Within 10 minutes of injection, patient started to say her eyes were moving by themselves behind her... Read more
Within 10 minutes of injection, patient started to say her eyes were moving by themselves behind her eye sockets and she was feeling alot of "snapping" in her body. Her blood pressure and pulse were higher than normal and she could not keep her eyes open well. She was observed by nurses for approx 30 minutes and those symptoms seemed to subside although she was not steady walking. Midway into our 30 minute drive home it all started again, this time she said she felt heaviness in her chest but was pointing to her throat. I immediately drove her directly to the ER. Was monitored for 4 hours and was release to go home, be observed and follow up with Neurologist when possible. Throughout the night, she continued to say she was shaking alot on the inside and her eyes were still moving involuntarily. 3/20/19 at 8:30 am I called her Neurologist to inform her patients symptoms were continuing. I waited 8 hours and called back only to have her tell her service I was to call patients Primary Physician. Which I did. Dr. was on call and quickly prescribed medication to help calm patients symptoms. She prescribed Valium 2mg q 6 hours. 3/21/19: Patient is still experiencing shakiness, involuntary eye movement and fatigue. She does not have arm pain at injection site.
34 2021-03-21 oropharyngeal discomfort No pain or adverse event for the first 4 hours after vaccination. Starting at 2pm, which was 4 hours... Read more
No pain or adverse event for the first 4 hours after vaccination. Starting at 2pm, which was 4 hours after my vaccine, , my chest began to tighten. It was not severe; I took a normal walk and was just mildly uncomfortable. It escalated hourly for about 10- 12 hours. At 8pm, the pain, pressure, and tightness around the chest went from mild to moderate, from a pain level of 2 to about 3 or 4. The sensation was one of a stack of books on my chest. There was pressure and mild pain (again, not severe), about 8-10 inches horizontally across my chest, from about the bottom of my sternum to the collarbone. I also felt some pressure in my lower throat, perhaps the bottom third of my neck. I did not have any shortness or breath, swelling, or difficulty swallowing. At about 9 pm, I became itchy on my neck, ankles, and flank. I developed some red spots, which were not large enough to be hives, They mostly became red from my itching, though they were more moderately itchy than seriously itchy. I have had hives before, and they did not appear to be hives, more just isolated red spots. Once I became itchy, I went to the ER. They worked me up for cardiac issues and a blot clot, but all tests were negative. I did not take any medication other than my standard Oxcarbazepine 8pm dose of 300 mg. The itchiness went away at about 11pm (two hours after onset), and the chest pain did not worsen. The following morning, it was significantly better, and about 36 hours after I first received the vaccine, it was gone entirely.
34 2021-03-21 ringing in ears, ear discomfort - Left ear ringing - Left ear sense of loss of hearing ( very noticeable) - Left ear blocked feelin... Read more
- Left ear ringing - Left ear sense of loss of hearing ( very noticeable) - Left ear blocked feeling - Right ear blocked feeling - Right ear sense loff of hearing ( relatively less compared to left ear)
34 2021-03-23 visual impairment I passed out about 20 min. after the shot. I felt fine up until then. When I was walking to wash my ... Read more
I passed out about 20 min. after the shot. I felt fine up until then. When I was walking to wash my hands, i felt intense heat, vision blacked out and I passed out for about 30 seconds. II was dizzy with delayed vision for the rest of the day.
34 2021-03-24 swollen tongue Swollen lymph node in neck. Swollen tongue Muscles in neck feel like I can?t relax them Hurts to s... Read more
Swollen lymph node in neck. Swollen tongue Muscles in neck feel like I can?t relax them Hurts to swallow- muscle in neck Fever Massive headache
34 2021-03-25 feeling of choking Pt was vaccinated at approximately 11:40 AM today. She was given the Pfizer vaccine and observed for... Read more
Pt was vaccinated at approximately 11:40 AM today. She was given the Pfizer vaccine and observed for 15 minutes. During the observation period, the patient complained of tingling in her throat. She had no throat or tongue swelling, no difficulty breathing, SOB. She was offered PO Benadryl but the patient declined and said she would like to "wait it out". She drank water, ate a snack and felt better. Pt left but upon walking outside to her car she said she felt like she couldn't breath so she returned to the vaccine clinic. Pt reported feeling better upon coming back inside. She had no further c/o SOB or trouble breathing. Pulse ox 99-100% on RA and HR WNL. Pt was given PO Benadryl at 1230 PM. Pt is feeling better. Brother picked her up. Instructed to go to the ER if symptoms return and to inform her doctor of what happened.
34 2021-03-27 tongue itchiness After receiving the vaccination, patient presented to pharmacy counter stating her "tongue is itchy"... Read more
After receiving the vaccination, patient presented to pharmacy counter stating her "tongue is itchy". We had her sit down and went over if she was experiencing any other symptoms. Patient stated No to the following: shortness of breath, dizziness, difficulty breathing, hives. Patient was feeling well otherwise and agreed to sit for a while longer at pharmacy. Upon discussion, she stated she did have a reaction following the 1st dose (itchy and hives) however this was several days after and her doctor believes this was related to a change in haircare product. After sitting for a few more minutes, patient was ready to go home even though he symptoms had not improved.....however nothing was worsening either. She was advised to go home and take diphenhydramine and monitor closely. After a follow-up phone call 24 hours later, patient said she was feeling better with the tongue itchiness, but now is experiencing more common side effects of headache and body aches.
34 2021-03-28 ringing in ears, ear pain 8-10 hours of severe nausea, headache in frontal lobe, muscle aches, joint pain, chills, 100 degree ... Read more
8-10 hours of severe nausea, headache in frontal lobe, muscle aches, joint pain, chills, 100 degree fever, sweating, ringing in ears, lymphs swollen, overall fatigue, chest pain with breathing, elevated heart rate, site of injection pain for 2 days deep inner ear pain for 6 days, headache subsided after the second day but came and went for 5 days I stayed in bed all of 3/22/21, stayed hydrated, took light soup toward the end of the day was able to walk 3/23, and resume eating regularly
34 2021-03-29 mouth numbness, mouth tingling within 30 minutes of the injection, my mouth and tongue started tingling and feeling numb at the sam... Read more
within 30 minutes of the injection, my mouth and tongue started tingling and feeling numb at the same time. It felt like there was swelling but I did not see swelling when looking in the mirror at the back of my throat, so the numbness may have just made it feel swollen, I'm not sure. The best way to describe it is that my mouth, tongue, and throat felt like I had just received a numbing injection at the dentist or gargled with lidocaine. My throat also got very itchy and it was slightly difficult to swallow. I took 50 mg of Benadryl upon arriving home after the vaccination. The numbness and tingling lasted about 7 hours. I did not see a doctor, as my breathing was fine. The next morning, my throat is still itchy but numbness and tingling are gone.
34 2021-03-29 vision blurred, taste impairment, eye strain Pain on arm where the vaccine was administered (immediate and ongoing after 11 days) Nausea, headach... Read more
Pain on arm where the vaccine was administered (immediate and ongoing after 11 days) Nausea, headache, tightness in chest, metallic taste in mouth (30 mins after vaccine until 5 hours after) Extreme tiredness, blurry vision, heavy eyelids (30 mins after vaccine and ongoing after 11 days) Cold Sores (3-5 days after vaccine) Warts on fingers (7 days after vaccine) Vaginal Vesicles (5-7 days after vaccine) Oral vesicles and irritated gums (9 days after vaccine and ongoing)
34 2021-03-29 vision blurred Vaccine was given in my left arm and I woke up in the morning with blurred vision in left eye. Coul... Read more
Vaccine was given in my left arm and I woke up in the morning with blurred vision in left eye. Could not read text, except for when I closed the left eye. However, the symptoms resolved after 3 hours
34 2021-03-30 mouth tingling Patient's reaction(s) noted during COVID vaccine observation period: pt stated she felt diaphoretic... Read more
Patient's reaction(s) noted during COVID vaccine observation period: pt stated she felt diaphoretic and lips felt a little tingly after 15 minutes of receiving vaccine Actions Taken: VS obtained 0845 HR 77, BP 129/63, T 98.1, O2 99%. Pt states she is feeling better now. VS at 0851: HR 93, BP 118/60, O2 97% Pt declined further medical observation. States she will take benadryl once she leaves if she feels she needs to. Disposition: pt walked out of clinic after observation
34 2021-03-30 sensitivity to light, extreme sound sensitivity Raised hives on chest and neck; lasting one hour Swollen hands color white and purple; lasting 20 m... Read more
Raised hives on chest and neck; lasting one hour Swollen hands color white and purple; lasting 20 min Swollen throat still able to breath; lasting 20 minutes Extreme fatigue; lasting through the end of 3/30 Migraine sensitive to all light and sound; lasting through the end of 3/30
34 2021-03-31 lip swelling, swollen lips Lips swollen with rash the reaction started the night of March 27th and got worse by the next mornin... Read more
Lips swollen with rash the reaction started the night of March 27th and got worse by the next morning. It continued to get worse and no one could figure out what it was. I went to the doctor twice in two days and my pcp wouldn't see me.
34 2021-03-31 mouth itchiness Pt reports itchy mouth. 25mg diphenhydramine PO admin per MD order. Vitals WDL, patient provided MD ... Read more
Pt reports itchy mouth. 25mg diphenhydramine PO admin per MD order. Vitals WDL, patient provided MD consult and discharge.
34 2021-03-31 swollen tongue Pt returned back to the vaccination room within 2-3 minutes from the lobby. She had a feeling of rus... Read more
Pt returned back to the vaccination room within 2-3 minutes from the lobby. She had a feeling of rush all over her body, she mentioned that she felt her tongue was swollen. She felt very anxious and nervous at the moment. I didn't notice any lips swollen, I asked a staff call 911 and monitored her closely. She calmed down after few minutes and then in 5 mins paramedics showed up. They checked her and she was totally fine. They send her home after 10 mins or so.
34 2021-03-31 thirst Beginning ~4 h after injection: mild arm ache at injection site ; beginning ~12 h after injection: ... Read more
Beginning ~4 h after injection: mild arm ache at injection site ; beginning ~12 h after injection: insomnia, moderate fatigue/malaise, muscle aches (particularly back/hips, which is unusual), low grade fever, mild nausea, loss of appetite, continual thirst, mild stuffy nose, increase in mild asthma symptoms previously controlled by medication, ache in left armpit possibly associated with lymph node; almost all symptoms resolved by 24 h after onset except residual mild arm/armpit aches and slight swelling of a lymph node at the left collarbone.
34 2021-03-31 vision blurred On Wednesday, March 31, 2021 client received her second dose of COVID vaccine at approximately 3:15... Read more
On Wednesday, March 31, 2021 client received her second dose of COVID vaccine at approximately 3:15pm. While in Observation Area, patient reported to EMTs on site she felt a sensation of "dizziness and some blurry vision" at 3:35pm and vitals were taken by EMT. Vitals at 3:35pm: BP: 124/82, HR: 72bpm, 02 sat: 98%. Lead PHN was alerted and client stated she experienced the same sensation of "dizziness and some blurry vision" with her first dose. Vitals were taken again at 3:47pm. Vitals: BP: 120/82, HR 90, O2 sat: 96%. Client was seated on the anti-gravity chair and given a bottle of water. Client was observed for an additional 30 minutes. At approximately 4:15pm client stated she felt "slightly better and not so dizzy." Reassessment of vitals were offered by EMT but were refused by client. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site at approximately 4:22pm with a steady gait.
34 2021-04-01 eye swelling My eye began to swell, and after about 36 hours my eyes began to swell shut and I was barely able to... Read more
My eye began to swell, and after about 36 hours my eyes began to swell shut and I was barely able to open them. I had a telehealth appointment in which they prescribed steroids to stop the swelling and with no other known causes said it may be a ?localized allergic reaction?. After my second shot I had swelling as well, but not as severe. My eyelids still are itchy and slightly swell. I?ve never had any reaction like this, and cannot confirm this was the vaccine but there?s no other changes in my life.
34 2021-04-01 gaze palsy Pt rec'd Covid 19 vaccine. Reported to RN about 10 min post vaccine that she felt like she was "goin... Read more
Pt rec'd Covid 19 vaccine. Reported to RN about 10 min post vaccine that she felt like she was "going to have a seizure". Pt has aunt accompanying patient and pt was A&Ox3. Pt reports hx of "pseudoseizures x 5 years". RN then noted pt eyes roll back in head. Pt unconscious and assisted to floor and turned on Left Side. Head protected by staff member. AED placed on patient. Seizure approx lasted about 1 min. Pt awoke and alert and arouseable to staff. Pt then began with another seizure lasting approx the same amount of time. Pt awoke non post ictal. She was alert & oriented. Refusing 911 call or go to ED as she reports "I've been checked out many times before, I do this". Bp 140/80's, HR stable and palpable. Pt then underwent 2 more seizures lasting approx same amt of time. 911 called at beginning of 2nd seizure. Upon arrival of EMS pt was still unarouseable and taken by EMS to ED. RN, BSN, CCM Nurse Navigator NMG
34 2021-04-02 mouth numbness Red rash all over chest, neck, shoulders, back, stomach and slightly on the legs. No itching but hot... Read more
Red rash all over chest, neck, shoulders, back, stomach and slightly on the legs. No itching but hot to touch almost feels like a sunburn. Extreme fatigue only for one day after the 2nd vaccine. The first vaccine I immediately had my lips go numb. Second vaccine I didn?t have the numbness in my lips and didn?t get fatigue, migraine until the next day. The second day is when I developed the rash.
34 2021-04-02 mouth ulceration Sore Throat (right side) on 4/2/2021 One ulcer on palatoglossal arch (right side)
34 2021-04-02 mouth tingling Tingly left side of my lip and cheek by my ear. Very mild but noticeable. Never became worse. Still ... Read more
Tingly left side of my lip and cheek by my ear. Very mild but noticeable. Never became worse. Still think I feel the tingle 24 hours later.
34 2021-04-02 swelling of eyelid Swelling in the left bottom eyelid and surrounding 3 inches for the past week.
34 2021-04-03 eye pain, sensitivity to light Headache, nausea within 15 minutes... was observed for 1 hour....also it is important to note that s... Read more
Headache, nausea within 15 minutes... was observed for 1 hour....also it is important to note that substantial less amount of caffeine on this day... possible withdrawls After leaving observation and exiting building... noticed light sensitivity while driving home. Eye pain that evening and next day... prickly pain like when you are over tired.
34 2021-04-03 swollen tongue, lip swelling Itchy back near left shoulder blade, swelling of throat, tongue, and lips, stuffy nose, racing heart... Read more
Itchy back near left shoulder blade, swelling of throat, tongue, and lips, stuffy nose, racing heartbeat, and feeling of impending doom.
34 2021-04-04 taste impairment About 24 hours after my shot on Thursday, I began to have shortness of breath, coughing, and needed ... Read more
About 24 hours after my shot on Thursday, I began to have shortness of breath, coughing, and needed to take my rescue inhaler. I needed to take it 2 more times within the next 24 hours. I was coughing and it was leaving the taste of blood in my mouth. I was not coughing anything up though. I wasn?t able to do a 3 minute task at home without coughing. By Saturday 48 hour later, I was still having shortness of breath, my lungs felt like they were burning, but it wasn?t as bad. By 8:00pm Saturday night the shortness of breath was gone and I was breathing easier. I still feel a slight tightness in my chest and coughing at the moment, but it feels like a residual cough like I would have after a cold. The only other effect I had was a sore arm after the shot which lasted about 4 hours and the next morning being slightly achy.
34 2021-04-04 oropharyngeal discomfort, lip swelling Patient came in to the pharmacy to receive second dose of the covid-19 vaccine around 1230pm on 4-2-... Read more
Patient came in to the pharmacy to receive second dose of the covid-19 vaccine around 1230pm on 4-2-2021. She stated that after she left from her first dose her jaw felt slightly weird but nothing more than that and it went away after a short wile. It was determined to give her the second dose but to monitor her for any reactions/anaphylaxis. She received the vaccine around 1:00pm from a pharmacy tech, and within 5ish minutes told my tech that her jaw line was tingling and her lips felt swollen. Pharmacist on duty, took the e-kit and went to check on her. She seemed to be talking fine and stated she wasn't having a hard time breathing. Pharmacist made the decision with the patient's consent to call 911 to be on the safe side. No meds were administered. Paramedics showed up, evaluated patient, and with the patient's consent, took her to the ER. The pharmacy followed up with the patient on 4-5-2021 to make sure she was okay. She said she was doing fine and that on 4-2-2021 her throat started to get prickly when she got to the ER so they administered bendadryl which helped.
34 2021-04-04 visual impairment, double vision Fever 103 3/27, stomach pain, vomiting, diarrhea, headache, chest pain, SOB Hospital 3/29, criticall... Read more
Fever 103 3/27, stomach pain, vomiting, diarrhea, headache, chest pain, SOB Hospital 3/29, critically low potassium, D-Dimer elevated, chest CT clear, admitted 3/30 HIDA scan, gallbladder removed 3/31 woke with vision issues, seeing multiples of things, slanted hallways, can?t stay awake 4/1 CT and MRI of brain show venous blood clot Started on blood thinners, stopped birth control (had only been on birth control about 5-6 months)
34 2021-04-05 eye pain, vision blurred 3/28/21 STARTED WITH HEADACHE - INCREASING IN SEVERITY ON 3/29/21, WITH PAIN BEHIND THE LEFT EYE. WE... Read more
3/28/21 STARTED WITH HEADACHE - INCREASING IN SEVERITY ON 3/29/21, WITH PAIN BEHIND THE LEFT EYE. WENT TO ED ON 3/30/21 FOR BLURRED VISION IN LEFT EYE. TREATED FOR MIGRAINE, DISCHARGED. WENT TO HER OPTHALMOLOGIST, DIAGNOSED WITH LEFT OPTIC NEURITIS. RETURNED TO ED FOR MRI OF BRAIN AND OPTIC NERVES, DIAGNOSIS CONFIRMED. TREATED WITH IV SOLUMEDROL AND ORAL MEDROL. PATIENT'S 7 MONTH OLD DAUGHTER AT SAME TIME DIAGNOSED WITH CROUP (VIRAL ETIOLOGY NOT IDENTIFIED). PATIENT IMPROVING POST STEROIDS.
34 2021-04-05 mouth tingling Initial tingling in tongue High heart rate High blood pressure Insomnia Swollen painful lymph no... Read more
Initial tingling in tongue High heart rate High blood pressure Insomnia Swollen painful lymph node
34 2021-04-06 ear pain, burning mouth syndrome Golf ball sized firm, tender nodule noted in right lateral breast on 4/2 at approximately 9pm. Righ... Read more
Golf ball sized firm, tender nodule noted in right lateral breast on 4/2 at approximately 9pm. Right sided scalp tenderness with hair brushing noted on 4/4 at 4pm. Right ear pain, pain on right side of tongue posteriorly, and pain with swallowing noted on 4/5 at approximately 8am.
34 2021-04-06 swelling around the eyes, eye itchiness, eye swelling Woke up with tchy swollen eyes, puffed up
34 2021-04-08 eye swelling, swelling around the eyes, eye discomfort My eyes started swelling last night with discomfort behind my eyes, today I am getting discoloration... Read more
My eyes started swelling last night with discomfort behind my eyes, today I am getting discoloration on the lids of my eyes. My eyes are noticeably puffy.
34 2021-04-08 lip swelling, mouth swelling Trouble swallowing at 5pm after injection administered at 9am. Woke up and 4am the following day wit... Read more
Trouble swallowing at 5pm after injection administered at 9am. Woke up and 4am the following day with swollen lips and mouth and around 9am noticed rash on legs and arms and a small amount on my belly.
34 2021-04-08 mouth tingling Patient felt tingling on lips and hot within 15 minutes of vaccination. Took Benedryl and was relea... Read more
Patient felt tingling on lips and hot within 15 minutes of vaccination. Took Benedryl and was released to home.
34 2021-04-08 mouth tingling Patient reported feeling hot and tingling on lips. Took Benedryl and was released to home.
34 2021-04-08 ringing in ears Woke up 1am with extreme headache crown of head. Chills, nausea. Weak limbs. Barely made it to bathr... Read more
Woke up 1am with extreme headache crown of head. Chills, nausea. Weak limbs. Barely made it to bathroom, had dhiarrhea. Fainted on bathroom floor. After about an hour was able to get back into bed. Shivering with 100 fever for 3 hours. Loud ringing in ears. Was blacking out. Still sick but the fainting and extreme episode at 1am seemed worth reporting and extreme
34 2021-04-11 ringing in ears, deafness unilateral Tinnitus, hearing loss in left ear, vertigo,
34 2021-04-12 taste impairment During observation period, patient reported tasting a metal taste in her mouth and throat. Requeste... Read more
During observation period, patient reported tasting a metal taste in her mouth and throat. Requested water. No other symptoms. Extended observation period, symptoms did not change, better or worse. Pt requested further evaluation. Escorted to Urgent Care on site.
34 2021-04-12 pain in jaw Side effects included: Constant muscle spasms all over body; numbness in right hand twice; right sid... Read more
Side effects included: Constant muscle spasms all over body; numbness in right hand twice; right side jaw pain; and headache. I took IBprofen for a couple days every 8 hours, but discontinued use after headache and jaw pain dissipated. However, The muscle spasms are still present three weeks after vaccine was administered.
34 2021-04-12 mouth tingling, feeling of choking Twenty minutes after injection, tongue and throat started tingling. Tingling grew in intensity quick... Read more
Twenty minutes after injection, tongue and throat started tingling. Tingling grew in intensity quickly. The sensation can be compared to having Pop Rocks candy in the mouth. Face became flushed red and paramedics were called. Faint redness on underside of arms. Sensation of heat felt in scalp and neck. Fainting occurred. Paramedics determined reactions were not life-threatening. Tongue and throat were not swollen. Tingling sensation slowly diminished over the next eight hours. About an hour after injection, diarrhea occurred.
34 2021-04-13 tongue itchiness, swollen tongue 1 April, woke up at 0800 with slight headache and felt fatigued but most noticeably my voice sounded... Read more
1 April, woke up at 0800 with slight headache and felt fatigued but most noticeably my voice sounded weird and my throat was extremely hoarse while talking in work meeting and I had to constantly cough to clear it. I was having a bit of trouble swallowing as well. In the afternoon, my headache got worse and I had diarrhea. Around 7:45pm I started feeling extreme itchiness and swelling in my tongue. This didn't improve, so I took 25mg Benedryl at 8:20pm, at which time my vitals were normal, but noticeably lower than usual with a HR of ~60, BP of 100/70, O2 sat 99% and normal temp. I also took another 1000mg Tylenol at 9:30pm and went to bed. 2 April, 0730 woke up and my throat and tongue started swelling again and were very itchy. I began have difficulty breathing and swallowing saliva. I also could not swallow a banana easily, so I stopped eating it. I also had some wheezing that would only go away with a cough. Took 25mg more of Benedryl and went to urgent care immediately because breathing was becoming increasingly difficult. Treatment: At urgent car I was diagnosed with anaphylactic reaction due to vaccination and given another 25mg Benedryl injection and 10mg Prednisone. Vitals were BP:144/90, HR:83, TMP 98.5. Doctor considered epinephrine instead of Benedryl but "didn't want to have to send me to the ER". I was monitored for about 45 minutes and while my difficulty breathing did not improve much, it also did not worsen. I was sent home with Medrol steroid pack, Atarax and an EpiPen. My breathing ability did not return to normal until about ~3 days later.
34 2021-04-14 taste impairment About 15-30 seconds after the vaccine, my heart was racing and I startedgetting lightheaded. My airw... Read more
About 15-30 seconds after the vaccine, my heart was racing and I startedgetting lightheaded. My airway was clear but I felt like I couldn't catch my breath. I had a metallic taste in my mouth and my hands started shaking. It lasted about 3-5 minutes. I sat down and drank cold water, did some breathing exercises, and it eventually subsided. I took half of a .25 mg Xanax about 20 minutes later to settle my nerves a bit.
34 2021-04-14 vision blurred, visual impairment, sensitivity to light, visual field defect, ringing in ears The patient was reportedly in her USOH until she received the first dose of the Pfizer vaccine on 1/... Read more
The patient was reportedly in her USOH until she received the first dose of the Pfizer vaccine on 1/4. She woke up the following morning with a terrible headache and photophobia, later in the day developing myalgias and generalized weakness, followed by possible fever (did not take home temp). She describes the headache as a throbbing holocranial ache that is worse if she bends down She states the headache never really went away fully over the ensuing days, and she did begin to notice blurred vision in her right eye; she eventually presented to Medical Center on 1/9, where she was tested for COVID-19 and found to be negative - her symptoms were attributed to a vaccine reaction and she was sent home. She continued to have a terrible headache and blurred vision, and so returned to Medical Center on 1/12. She then presented to another Hospital she was admitted for frequent falls in the context of elevated blood pressure. Workup there included a head CT, which was unremarkable. She was discharged with home PT. On the day of presentation, she fell at physical therapy. Now with pain from R knee down. No numbness in the leg. States leg twisted when she fell. No head strike or LOC. States pain with attempted ambulation. This resulted in her presentation to the ED at a Medical Center on 1/27/21. On evaluation, she endorsed a headache, holocranial, throbbing, 5-6/10 (has been 10/10). Denies frank positional component. Not worse at any certain time of day. +Blurred vision, worse on the R. +photophobia, not phonophobia. Also complains of pulsatile tinnitus happening almost daily, R-sided, worse when bending down. Denies nausea or vomiting. Denies neck pain or stiffness. Exam was notable for significant peripheral vision loss in R>L eye and bilateral papilledema. She was seen by ophthalmology with documentation of formal visual field testing (reports included). MRV with filling defects in straight, sagittal, and R transverse sinuses; MRI without FLARE changes, reassuring for no obstruction and/or infarct.
34 2021-04-15 ear pain Systemic: Bilateral Ear Pain-Severe
34 2021-04-15 lip swelling After second dose, lips became extremely swollen. I had lip injections (Juvederm Volbella) on March ... Read more
After second dose, lips became extremely swollen. I had lip injections (Juvederm Volbella) on March 15th.
34 2021-04-15 ringing in ears 24 hours after injection had hives on face, loud rushing sounds in ears, respiratory distress. Took ... Read more
24 hours after injection had hives on face, loud rushing sounds in ears, respiratory distress. Took benedryl and had epi pen ready but never had to administer it. Severe symptoms lasted 3 hours, went to dr next day and began steroids. Unsure if I was exposed to another allergen during the 24 hours but determined it was possible. Had 7 days of severe allergic response side effects of brain fog, loud rushing heart beat noise in head, hives, sensitivity to all allergens , swollen face
34 2021-04-15 vision blurred Dizziness, nausea, pinching pain in left thigh, and then I collapsed. I had to go to the hospital an... Read more
Dizziness, nausea, pinching pain in left thigh, and then I collapsed. I had to go to the hospital and all tests looked normal. Ultrasound for blood clot did not show any clotting. That was two days ago. Today my vision is blurred, body aches and chest pain on the right side (Injection side.)
34 2021-04-16 lip swelling 4/15- Had what looked to be heat rash on arms in the morning. Took benadryl before bed. 4/16- Woke ... Read more
4/15- Had what looked to be heat rash on arms in the morning. Took benadryl before bed. 4/16- Woke up with head to toe rash and swollen. Went to emergency remove. Received steroids. Redness and swollen reduced by afternoon. 4/17- Woke up with redness head to toe and lips swollen. Fingers tingly and soreness throughout body.
34 2021-04-17 deafness unilateral, ringing in ears Tinnitus and hearing loss in right ear. Stuffed sinus. Headache. Mussel ache.
34 2021-04-18 mouth itchiness Itching in mouth around 30 to 40 minutes after shot administered, the rest of body itching for about... Read more
Itching in mouth around 30 to 40 minutes after shot administered, the rest of body itching for about 10 hours after. No impact to breathing, no hives visible.
34 2021-04-18 mouth tingling, swollen tongue About 5 minutes after injection (Pfizer dose #2), patient felt tingling in tongue, then swelling sen... Read more
About 5 minutes after injection (Pfizer dose #2), patient felt tingling in tongue, then swelling sensation in tongue, then cough. Took Epipen, Benadryl 50 mg po, albuterol inhaler... exam showed clear lungs, tachycardia, "geographic tongue". Via ambulance to ED.
34 2021-04-18 visual impairment Arm where injection was administered felt pins and needles and then went numb, vision changes and ex... Read more
Arm where injection was administered felt pins and needles and then went numb, vision changes and extreme light headedness, confusion - all felt within minutes of shot and lasted for only 25 minutes. Exhaustion followed.
34 2021-04-20 pupils dilated Systemic: Fainting/Unresponsive-Medium, Systemic: Seizure-Mild, Additional Details: Patient's pupils... Read more
Systemic: Fainting/Unresponsive-Medium, Systemic: Seizure-Mild, Additional Details: Patient's pupils were dilated and affixed; then slight resemblance of a seizure, slight shaking and twitch, noise like to vomit; then she passed out. She regained alertness, but then passed back out again. 911 was called while NP took her oxygen level. Ambulance took her to ER where blood pressure was stabilized and blood work was checked. I contacted patient today to check on her and she was ok, normal, asked if ok to get second dose of vaccine when due.
34 2021-04-20 swollen tongue, tongue itchiness throat and tongue started swelling again and were very itchy; throat and tongue started swelling aga... Read more
throat and tongue started swelling again and were very itchy; throat and tongue started swelling again and were very itchy; difficulty breathing; swallowing saliva; wheezing; noticeably lower than usual with a HR of ~60, BP of 100/70; feeling extreme itchiness and swelling in my tongue; itchiness in her tongue/throat and tongue started were very itchy/feeling extreme itchiness and swelling in her tongue; slight headache/ Headache got worse; felt fatigued; voice sounded weird/my throat was extremely hoarse; constantly cough; upset diarrhea; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 31Mar2021 16:45 at age of 34-year-old (Batch/Lot Number: ER8732) at single dose for COVID-19 immunization. Medical history included Von Willebrands Type 1, and a family history of auto-immune issues like myasthenia gravis, lupus and Chronic inflammatory demyelinating polyradiculoneuropathy. Patient had known allergies to coconut, latex. Concomitant medications included norethindrone acetate and ethinyl estradiol. There was no other vaccine in four weeks. On 01Apr2021, the patient woke up at 08:00 with slight headache and felt fatigued but most noticeably her voice sounded weird and her throat was extremely hoarse while talking in work meeting and she had to constantly cough to clear it. Headache got worse in the afternoon and she had upset diarrhea. Around 19:45 she started feeling extreme itchiness and swelling in her tongue. This didn't improve, so she took 25mg diphenhydramine hydrochloride (BENADRYL) at 20:20, at which time her vitals were normal, but noticeably lower than usual with a heart rate of 60, blood pressure of 100/70, O2 sat 99% and normal temperature. She also took another 1000 mg paracetamol (TYLENOL) at 21:30 and went to bed. 02Apr2021, 07: 30 woke up and her throat and tongue started swelling again and were very itchy. She then began had difficulty breathing and swallowing saliva. She also could not swallow a banana easily, stopped eating it. She also had some wheezing that would only go away with a cough. She took 25mg more of diphenhydramine hydrochloride and went to urgent care immediately because breathing was becoming increasingly difficult. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment for the events included diphenhydramine hydrochloride injection and prednisone. There was no COVID prior vaccination. There was no COVID tested post vaccination. The patient recovered from the events in Apr2021.
34 2021-04-21 blindness Ocular migraine. No history of migraines or ocular problems of any kind. Partial lose of vision. Af... Read more
Ocular migraine. No history of migraines or ocular problems of any kind. Partial lose of vision. After vision was restored pain around eyes.
34 2021-04-21 ear pain Around 10 hours out started to develop a fever. Body aches, headaches, chills and uncontrollable sha... Read more
Around 10 hours out started to develop a fever. Body aches, headaches, chills and uncontrollable shaking. Fever peaked at 101.7 and lasted for 7 hours at that temp. During that time heart rate was resting at 110bpm. Also experienced ear pain in both ears. Still have fever of 100 degrees more than 24 hours after the shot, so symptoms ongoing. Used ibuprofen to help, but had mild impact. Tepid shower. Lots of fluids. At no point did the fever ever cause me to sweat.
34 2021-04-21 lip swelling Within 15 min had oral itchiness and puffy lips. Was given 25mg of benadryl. Within 48 hours had ful... Read more
Within 15 min had oral itchiness and puffy lips. Was given 25mg of benadryl. Within 48 hours had full body itchiness
34 2021-04-22 ear discomfort, hearing loss, ringing in ears Partial hearing loss, tinnitus. Both ears feel "muffled" and "stuffy" and are ringing loudly. First,... Read more
Partial hearing loss, tinnitus. Both ears feel "muffled" and "stuffy" and are ringing loudly. First, the left ear started feeling that way, and then the next day, the right ear started feeling it and the left ear got worse.
34 2021-04-22 eye swelling Fever, Body aches, Migraine left side of temple redness and eye swelling, still have lingering heada... Read more
Fever, Body aches, Migraine left side of temple redness and eye swelling, still have lingering headache
34 2021-04-22 mouth tingling, mouth numbness Numbness and tingling in face, scalp, tongue and legs
34 2021-04-22 mouth tingling, lip swelling Pt received covid-19 vaccine, 2nd one ~ 3:10 pm. Approx 10 minutes later experienced some chest tigh... Read more
Pt received covid-19 vaccine, 2nd one ~ 3:10 pm. Approx 10 minutes later experienced some chest tightness (but not shortness of breath or wheezing) and feeling some lip swelling and tingling as well as facial itching. She also felt somewhat ill in general. She laid down. After 20 more minutes she got up and felt worse with more facial itching and also now nauseous. She was sent to ED. From ED record - The patient received 4 mg IV zofran, 50 mg of Benadryl IV, 20 mg of Pepcid IV, 125 mg of Solu-Medrol IV and a 1 L normal saline bolus for hydration and possible allergic reaction. She felt better with improvement in symptoms and was discharged home in good condition. A course of prednisone and an epi pen was prescribed to her.
34 2021-04-22 ringing in ears Ongoing crackling in ear and dizziness (vertigo-like), tachycardia (elevated heart rate) around 36 ... Read more
Ongoing crackling in ear and dizziness (vertigo-like), tachycardia (elevated heart rate) around 36 hours post vaccine and ongoing symptoms now for 72 hours.
34 2021-04-23 chapped lips, lip swelling After both first and second shots: swelling and chapping of the upper lip starting within 48 hours a... Read more
After both first and second shots: swelling and chapping of the upper lip starting within 48 hours and lasting 24-48 hours (swelling remained minor, but I did take antihistamines - Xyzal specifically) Extreme tenderness and soreness in the injection area After second shot (03/22/2021): chills, low fever, headache, and achiness (I gather these are pretty normal reactions)
34 2021-04-23 fluid in middle ear, ear discomfort, ringing in ears Fullness and fluid in ears that has led to tinnitus and hearing problems; have taken antibiotics for... Read more
Fullness and fluid in ears that has led to tinnitus and hearing problems; have taken antibiotics for 9 days and nothing has changed. Still having humming, whirring, and buzzing sounds in left ear
34 2021-04-23 mouth itchiness Patient reports having mouth itchiness about 45 minutes after receiving vaccination. She had already... Read more
Patient reports having mouth itchiness about 45 minutes after receiving vaccination. She had already left vaccination site and noticed symptoms once she got home. The symptoms lingered for a few hours which prompted her to return to site. Her vitals were stable and clinical exam was reassuring, no appreciable oral edema. Airway patent. Patient given 50mg oral Benadryl and monitored for 1 hour. On reassessment patient stated symptoms completely resolved and she was discharged to home. She was advised to continue to monitor for symptoms, have someone drive her to follow up vaccination.
34 2021-04-23 photosensitivity reaction Mildly sore injection site in my left arm for 48 hours post vaccine; moderate lateral knee pain in b... Read more
Mildly sore injection site in my left arm for 48 hours post vaccine; moderate lateral knee pain in both knees 12 to 36 hours post vaccine; moderately swollen lymph node under my left clavicle 4 days post vaccine (currently experiencing); mild confusion and fatigue12-24 hours post vaccine; easily sunburned for just a short time in the sun 18 hours post vaccine (not normal for me); hot flashes 24 to 48 hours post vaccine.
34 2021-04-23 visual impairment, ringing in ears Chest and neck tightness/pain, shortness of breath, dizziness, ears ringing, vision spotty followed ... Read more
Chest and neck tightness/pain, shortness of breath, dizziness, ears ringing, vision spotty followed by sweating and weakness.
34 2021-04-24 swelling around the eyes, eye itchiness I received the 2nd dose of the vaccine on Friday morning. When waking up on Saturday morning, my eye... Read more
I received the 2nd dose of the vaccine on Friday morning. When waking up on Saturday morning, my eyes were itchy, puffy, and my face had hives with small, white bumps. The hives are mainly on my eyelids, cheeks, and my upper lip.
34 2021-04-24 ringing in ears Intermittent ringing in ears - Begin approximately 2 hours after injection and lasted for about 6 ho... Read more
Intermittent ringing in ears - Begin approximately 2 hours after injection and lasted for about 6 hours Body aches - began approximately 12 hours after initial injection and lasted for approximately 24 hours Lethargy/very tired - Begin approximately 12 hours after injection and lasted approximately 24 hours
34 2021-04-25 lip swelling, lip itchiness, mouth discomfort On April 1, 2021, Upon arriving home from the vaccine shot (within two hours of the shot) I changed ... Read more
On April 1, 2021, Upon arriving home from the vaccine shot (within two hours of the shot) I changed my clothes and noticed hives across my chest and down the front of my stomach. I immediately took a benadryl and they were gone the next morning. On April 24, I again had hives this time up my back and throughout my left arm. I didn't take a benadryl right away and then my lips started to itch/burn and get swollen. I took a benadryl and again the symptoms were gone in the morning. That was Saturday 4/24/21 it is now Monday 4/26/21, and I have not been feeling too well. Prior to the vaccine, I have never had hives on my body. Since getting the shot on April 1, 2021, I have broken out twice. Once immediately after, and again 3 weeks later.
34 2021-04-25 lip swelling, mouth discomfort I believe I had a delayed reaction to the COVID-19 vaccine that appeared three weeks after my second... Read more
I believe I had a delayed reaction to the COVID-19 vaccine that appeared three weeks after my second dose. My lips swelled up rather severely and were burning and very itchy. When I first went to the doctor, we concluded it was a contact dermatitis reaction to some spicy wings I ate. However, the problem persisted for almost five days and started to get worse, which (I'm told) is very unlikely for a food allergy. I ended up going to another primary doctor the next day and she is the one who ended up prescribing an oral steroid and topical steroid. That finally took care of the issue. I would have reported this through VAERS sooner, but was not aware of it. A few days after I started the steroid, I happened to have a dermatology appointment, and my dermatologist said she was aware of delayed reactions tied to vaccines and believed I had angioedema from the COVID-19 vaccine.
34 2021-04-25 sensitivity to light, extreme sound sensitivity Severe Headache. Started late morning the day after vaccine. Took 1500mg Acetaminophen which gave re... Read more
Severe Headache. Started late morning the day after vaccine. Took 1500mg Acetaminophen which gave relief after 1 hour. Headache returned in less than 6 hours. Took another 1500mg doses every 12 hours for the past 5 days. Severe headaches continue and have been constant. Note: today's headache is beginning to return only 3½ hours after 1500mg dose of acetaminophen. Location of headache starts in the eye area, specifically at the brow bone and spread up to the top of the skull. Sensitivity to light and sound accompanying headache.
34 2021-04-25 sensitivity to light, visual impairment, taste disorder, ringing in ears During injection 10:20 am Apr. 7th tasted plastic and had mild facial swelling. That night woke up ... Read more
During injection 10:20 am Apr. 7th tasted plastic and had mild facial swelling. That night woke up 1:30 am with worst headache I'd ever had all across top of my skull, diarrhea, started seeing black when I blinked, then fainted on bathroom floor. Felt like someone was throwing buckets of cold water on me. Dizzy, couldn't get off bathroom floor. Tinnitus off and on. Mom was with me and she called GP emergency nurse who urged us to go to ER, decided to wait because I felt too ill to move. 100 degree fever. Stayed ill like I had the flu for next several days in bed. Noticed heart seemed irregularly fast from time to time, and dizzy when I stand up. Brain fog was very strong. By 4th day body aches started to improve but still very weak. Legs shaking in the shower, feeling sick if I walk or stand more than 20 minutes. Day 8th, Apr. 15th went to ER because of increasing weakness in legs. They wanted to do spinal tap and MRI, but after neurologist evaluated he said my reflexes are too good for GBS. ER also nasal swabbed me, negative for COVID. Day 10 fever came back, 100 degrees. Now it's day 19. I'm consistently weak in my legs and arms. Saw the neurologist again last week. He said if I'm still not better this Thursday he will give me an EMG, so I plan to proceed with that. My legs still shake in the shower. Haven't felt well enough to drive or walk down the street because my legs and arms are still weak and I feel like I have the flu if I exert myself. Have to rest in bed a lot. Sunlight hurts my eyes. Don't feel like myself, still feel like I'm having brain fog. Headaches off and on ongoing. If I rest in bed for four hours or so, I start to feel better, but If I exert myself at all I become nauseous and dizzy again. I have spent most of the last 19 days in bed. I?ve not felt well enough to drive my car or go for a walk outside this whole time.
34 2021-04-26 deafness, ear pain, ear discomfort Both ears with pressure and pain further past ear canal. Hearing is loss. Hearing is as if have a co... Read more
Both ears with pressure and pain further past ear canal. Hearing is loss. Hearing is as if have a cold, but no cold present. 04/27/2021 Around noon random migraine attacks through out day.
34 2021-04-26 dry mouth 34 y/o female, with past medical history of Covid (1 year ago), who presents with dizziness and dry ... Read more
34 y/o female, with past medical history of Covid (1 year ago), who presents with dizziness and dry mouth onset post vaccination. Patient states that this is her first vaccination in the two-dose series. Patient denies previous reaction to vaccination in the past. Vaccination site to the L arm. NP and Paramedics at patient side. Patient provided with a bottle of water. All vitals within normal limits (122/71 BP, 99% RA, 73 HR, 10 Resp, Glucose 90). Patient placed in wheelchair and brought to lay on the Trendelenburg cot. At this time patient was placed on 3L O2 by nasal cannula. Patient at this time states that she is somewhat scared of needles and when she had Covid over a year ago, she suffered from dry mouth lasting 6 months. Patient states that the dry mouth she is experiencing now is the same after her infection. Patient states that a mint usually improves her symptoms. Patient denies sore throat, difficulty swallowing, difficulty breathing, itch or rash. Patient provided with a mint and continuously monitored by the NP and paramedics. Within 30 minutes patient symptoms improved, dizziness resolved, and dry mouth subsided with the use of the mint. Patient was able to ambulate to the bathroom with NP and female Paramedic at side. Patient states that she feels better. Patient was cleared to go home after being observed for 30 minutes.
34 2021-04-27 drooling **Pt has complaining of difficulty breathing/swallowing, nausea, body feeling heavy. Staff observed... Read more
**Pt has complaining of difficulty breathing/swallowing, nausea, body feeling heavy. Staff observed patient going in and out of consciousness, drooling, and hands cold to the touch. ** Epi-pen administered at 7:50pm on 4/27/21 and 911 called ** Paramedics arrived and took pt away
34 2021-04-27 swollen tongue Hives, tongue swelling, shortness of breath, heart palpitations, chest pain
34 2021-04-28 dry throat, swollen tongue, dry mouth, oropharyngeal discomfort About 5 minutes after receiving the vaccine, my throat started feeling dry, scratchy, tight/mildly c... Read more
About 5 minutes after receiving the vaccine, my throat started feeling dry, scratchy, tight/mildly closed up. It was mild, so I just waited it out. At home about 2-3 hours later my mouth felt dry still and my tongue felt mildly swollen. All very mild, breathing and talking normally so I did not seek treatment. But still seemed like a mild allergic reaction.
34 2021-04-28 mouth swelling Pt reported tonsils feeling numb and mouth feeling swollen. Pt had unlabored respirations and repor... Read more
Pt reported tonsils feeling numb and mouth feeling swollen. Pt had unlabored respirations and reported no difficulty swallowing. Pt was also diaphoretic. Pt reported allergies to ciprofloxacin and history of asthma. Pt given water and able to swallow water. Pt's vitals were: BP 140/92 mmHg, HR 70 bpm, and SpO2 98%. Pt offered diphenhydramine. Pt given oral diphenhydramine 25 mg//10 ml (2 doses). Pt advised to wait for further observation. Pt reassessed at 1023. Vitals were 132/74 mmHg, HR 78 bpm, and SpO2 98%. Pt reported her earlier symptoms resolved and reported feeling sleepy. At approx. 1024, pt left facility to husband with unlabored respirations and steady gait.
34 2021-04-29 mouth numbness, swollen tongue After 2nd dose of Pfizer vaccine. On arrival, VSS HR 80s BP 119/82 O2 sat 99% on room air denies dif... Read more
After 2nd dose of Pfizer vaccine. On arrival, VSS HR 80s BP 119/82 O2 sat 99% on room air denies difficulty breathing or chest pain. Per patient 1st dose of vaccine had some numbness of lips this time left side of lips numb and spread to tongue, "tongue feels swollen." On assessment no facial droop present. Patient also c/o feeling more drowsy and slower to talk. Transported to ED via wheelchair for monitoring. Care assumed by ED RN.
34 2021-04-29 eye discomfort DAY 1 - MARCH 19TH - 30 SECONDS AFTER INJECTION ( PAIN IN LEFT QUAD 3 MINUTES AFTER INJECTION CONFU... Read more
DAY 1 - MARCH 19TH - 30 SECONDS AFTER INJECTION ( PAIN IN LEFT QUAD 3 MINUTES AFTER INJECTION CONFUSION (BRAIN FOG) 5-40 MINUTES AFTER INJECTION BRAIN FOG AND LIGHT HEADEDNESS (MINOR PAPITATIONS (AT 4:15 THE NURSES TOOK MY VITAL SIGNES AND MY BLOOD PRESSURE AND PULSE WAS RAPIDLY FLUCTUATING FROM HIG TO LOW FOR ABOUT 2 MINUTES TOTAL I WAS BEING MONITORED) I STARTED TO FEEL LESS CONFUSED AND LESS LIGHT HEADED BY AROUND 4:40 THEY LET ME LEAVE. DAY 2 - THE NORMAL BODY ACHES WEREN'T ANYTHING I WOULD EVEN BOTHER TO COMPLAIN ABOUT (MOVED AROUND TO DIFFERENT PART OF MY BODY ABOUT EVEY 10 MINUTES) TIRED AND SLEP DAY 3 - STILL TIRED AND THE BODY ACHES WERE STILL MINOR BUT APPARENT - PAIN IN MY LEFT LEG CAUSE ME TO LIMP. LASTED FOR ONLY ONE HOUR.... THEN RETURN A COUPLE HOURS LATER AND LASTES FOR ABOUT ONE HOUR AGAIN. DAY FOUR - FELT LESS TIRED. LESS BODY ACHES... BUTHAD A MIGRAINE. DAY FIVE - SEVERE PALPITATIONS, LIGHTHEADEDNESS, TROUBLE CONCENTRATING. COULD NOT FOCUS , CLOSE TO BLACK OUT FAINTNESS FEELING (AS IF I STOOD UP TO FAST BUT BY DOING NOTHING) PULSING IN MY CHEST, FELT LIKE MY EYES WERE SINKING INTO MY HEAD TYPE OF PRESSURE, PULSE PULSING IN MY NECK AND SEVERE HEAD PRESSURE. THESE SYMPTOMS LASTED FOR THREE DAYS TOTAL (SO FROM DAY 5-DAY 8 I FELT AS IF I WAS HAVING SOMETHING LIKE A HEART ATTACK OR A STROKE)
34 2021-04-29 mouth tingling Redness, throat swelling, tongue tingling, itching all over, heart palpitations. Gave me hydroxyzine... Read more
Redness, throat swelling, tongue tingling, itching all over, heart palpitations. Gave me hydroxyzine, sent me home. Every time it wore off, my throat would start swelling again so I took more continued for 4 days then stopped but heart palpitations are still. Happening now
34 2021-04-29 ringing in ears, vision blurred Shortness of breathe and chest pain: went to the ER twice between 4/2-4/16. Ringing in ear and blu... Read more
Shortness of breathe and chest pain: went to the ER twice between 4/2-4/16. Ringing in ear and blurred vision. Constant ringing in ear, went to urgent care on 4/29 because it?s unbearable. Seeing white spots and minor headaches
34 2021-04-30 bloodshot eyes small red spot on right eye; Pain in left arm; This is a spontaneous report from a contactable consu... Read more
small red spot on right eye; Pain in left arm; This is a spontaneous report from a contactable consumer, reporting for herself. A 34-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: ER87Z7), via an unspecified route of administration in the left arm on 29Mar2021 at 13:45 at a single dose for covid-19 immunisation. Medical history included polycystic ovary syndrome (PCOS), fibromyalgia, rheumatoid arthritis, Hoshimoto's, and hypothyroidism. There were no known allergies. Concomitant medications included unspecified thyroid prescription, pain reliever, vitamins and supplements (as reported), given in two weeks. There were no other vaccinations given in prior four weeks. On 29Mar2021, the patient experienced small red spot on right eye and pain in left arm for two days, which were non-serious. There was no treatment given in response to the events. There was no covid prior to or post vaccination. The clinical outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
34 2021-04-30 ringing in ears Fever, chills, body aches, severe headache, ringing in the right ear (later in the day for about two... Read more
Fever, chills, body aches, severe headache, ringing in the right ear (later in the day for about two hours), loss of appetite, day 2 post shot included severe lymph node swelling (swallowing impacted), injection site pain/warmth/swelling (3 days)
34 2021-04-30 ringing in ears I ended up feeling slightly sick with sore arm about 30ish hours after and I thought that was it. . ... Read more
I ended up feeling slightly sick with sore arm about 30ish hours after and I thought that was it. . About 3 days later I ended up having very severe symptoms that landed me in the E.R. 3 times in one week and stayed in the hospital for a few nights. I truly did not know if I would be making it home. I did have a sinus infection prior to this but was cleared to get the vaccine from my DR. I had all the side effects I couldn't walk very dizzy ringing in ears, (heightened my VM symptoms) fevers as high as 104.7 So lethargic and confused I didn't know my address.. on the top of all the worse symptoms you can possible think of DRS had to run lots of test, blood work, cat scans , x-rays, and spinal tap because one Dr said my body was in over drive had too many antibodies and kept fighting infections and one lead to viral meningitis . I am so THANKSFUL and so happy my body was able to fight it, I will NOT be getting the second one.
34 2021-05-03 ear pain I had a Bell?s palsy episode Thats lasted at least 3 days and is still healing. Corner month on the ... Read more
I had a Bell?s palsy episode Thats lasted at least 3 days and is still healing. Corner month on the top of my right lip was frozen and my eye brow was drooped. I initally had weakness and stiffness al over the right side of my face and ear pain in and around the ear and radiating down my neck. Muscles for swallowing on that side were weak as well. It?s slowing resolving but I?m still suffering tightness, weakness and pain.
34 2021-05-03 thirst I've been feeling very tired since April 21st. Tired to the point that I am incapable of performing ... Read more
I've been feeling very tired since April 21st. Tired to the point that I am incapable of performing routine tasks such as preparing breakfast for my children and taking them to school. My brain feels fuzzy. I am not able to perform my routine office work either. I have been on leave since my symptoms started. I can feel my heart beating very fast at times. At other times I find myself trying to catch my breath while doing routine things like eating food and drinking water. I also feel excessively thirsty.
34 2021-05-03 ringing in ears, visual impairment Headache, brain fog, forgetfulness, fever, fatigue, nausea, weakness, neck and back pain, not seeing... Read more
Headache, brain fog, forgetfulness, fever, fatigue, nausea, weakness, neck and back pain, not seeing clear, ringing in ears, dehydration, high blood pressure, dizzy, hard to catch my breath, sweating through clothes at night, body ache.
34 2021-05-04 mouth numbness Throat and tongue went numb minutes after injection.
34 2021-05-05 loss of taste, loss of smell Fever or Chills New loss of taste or smell Sore throat Congestion or running nose
34 2021-05-05 loss of smell, loss of taste New loss of taste or smell
34 2021-05-05 eye swelling About 24 ours after, I experienced severe headaches, chills and fever. They went on for the next day... Read more
About 24 ours after, I experienced severe headaches, chills and fever. They went on for the next day. Also, my left eye is swollen after I began to experience the symptoms. Later that day, I began to feel horrible pain on left arm. My lymph nodes were swollen on the side of my left arm where they put the vaccine. I had a dry cough that was constant. It wouldn't go away. I was having fever and chills and large swollen lymph nodes and then this cough. So I thought I had COVID. I had to call off the next day. The headache has lingered on since then. I still have the headaches although not as severe as at first. This headache is very different - on the back of my head on the left side. It feels like a burning pain on the back of my head and that's how I felt the headache the very first day. Heart palpitations started 2 weeks after the vaccine. They were happening on and off. I ended up in the Urgent Care on the 7th of April- for heart palpitations - They put a heart monitor on me because they couldn't figure out what was going on. Lingering headaches - I woke up with a headache - and that's never happened before all of this - burning sensation on back of my head on left side. Doctor is trying to figure out what is happening. I have been on two courses of antibiotics and they don't resolve anything.
34 2021-05-05 lip swelling Extreme swelling in face/lips after injection of Restalyne
34 2021-05-05 swelling around the eyes I came down with a bad headache about 2 1/2 hrs after the shot, but then at approximately 11am my ri... Read more
I came down with a bad headache about 2 1/2 hrs after the shot, but then at approximately 11am my right eye developed a red welt on the eyelid and then my eye proceeded to puff up until it was swollen and my eyeball was bright red.
34 2021-05-05 vision blurred Dizziness, blurred vision, paresthesia's, dropping things, low grade fever, arthralgias, myalgias, c... Read more
Dizziness, blurred vision, paresthesia's, dropping things, low grade fever, arthralgias, myalgias, chills, and vertigo.
34 2021-05-07 ringing in ears Bad tinnitus
34 2021-05-08 eye itchiness, eye irritation, lacrimation increased, dry eye 1st dose: wirhing ~6 hrs: extreme itchy face (forehead and cheek area), eyes, and inside nose (simil... Read more
1st dose: wirhing ~6 hrs: extreme itchy face (forehead and cheek area), eyes, and inside nose (similar itchiness to what happens when spinal block epidural wears off (I've had 3 c-sections). 2nd dose: within 2 hours: itchy scalp, itchy eyes, some itchiness around nose and eyes, and itchy inside nose: 24 hours: burning eyes watery eyes and low grade fever; 36 hours: dry eyes and clogged tear ducts
34 2021-05-09 loss of taste Lost of taste
34 2021-05-12 swollen tongue Vaccine given 4/29/21 at 11 am, by 2200 had h/a, nausea, brain fog, fatigue. hives and chest pain... Read more
Vaccine given 4/29/21 at 11 am, by 2200 had h/a, nausea, brain fog, fatigue. hives and chest pain. Took increased antihistamines at that point, this continued until 5/5 when she began having tongue swelling and went to the ED. Was given steroids, observed for 2 hours, and sent home with prednisone 20 mg BID 4 day burst. On final day of steroids developed hyperglycemia
34 2021-05-12 swollen tongue Hives, heart palpitations, red blotchy skin on legs, chest pain, tongue swelling, throat numbness
34 2021-05-13 taste disorder Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; Se... Read more
Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; This is a spontaneous report from a contactable pharmacist (patient). A 34-years -old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot Number: EL9262) (non-pregnant at the time of vaccination) via unspecified route of administered in arm left on 26Jan2021 at 11:00 AM as SINGLE DOSE for COVID-19 immunisation. The patient's medical history included known allergies: sulfa antibiotics. Concomitant medications (list of any other medications the patient received within 2 weeks of vaccination) included sertraline, baclofen, tylenol, pantoprazole. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot Number: EL1284) via unspecified route of administered in arm left on 05Jan2021 at 10:30 AM as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 26Jan2021, at 12:30 PM the patient had severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache. It was unknown whether the patient received treatment for the events. The outcome of the events was not recovered/ not resolved. Follow-up attempts are completed. No further information was expected.
34 2021-05-14 eye twitching, eye movement disorder Chest pain/tightness. Went to ER. Chest xray and EKG came back normal. Felt like I was having a hea... Read more
Chest pain/tightness. Went to ER. Chest xray and EKG came back normal. Felt like I was having a heart attack. Weird eye movement, eyes flutter especially when closed and I cannot sleep because of it. I have also have brain zap sensations. Neuropathy, legs and feet have been off and on asleep. Constant low grade fever. Tendonitis. Spasms in legs and arms. I have an appointment to see a neurologist. I am 34 years old and never had a medical issue before until after I took this vaccine.
34 2021-05-14 visual impairment hallucinations; Severe pain unable to lift left arm; severe body/joint aches; severe body/joint ache... Read more
hallucinations; Severe pain unable to lift left arm; severe body/joint aches; severe body/joint aches; severe headache; black spots in vision; weakness; fatigue; insomnia; confusion; nausea; stomach pain; chills; fever; Pregnancy at time of Vaccination: Yes; This is a spontaneous report from a contactable consumer reported for herself. This 34-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) via an unspecified route of administration in the left arm on 28Apr2021 01:00 PM at the same age as single dose for COVID-19 immunisation. Medical history included Leiden factor V and pregnancy. Concomitant medications included minerals nos/vitamins nos (PRENATAL VITAMINS), folic acid, labetalol, acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) on 01Apr2021 at 03:00 PM for COVID-19 immunisation, experiencing exposure during pregnancy; received amoxicillin;clavulanic acid (AUGMENTIN) experiencing severe vomiting but not an anaphylactic reaction. The patient experienced severe pain unable to lift left arm, severe body/joint aches, severe headache, black spots in vision, weakness, fatigue, insomnia, confusion, nausea, stomach pain, chills, fever, hallucinations; on 29Apr2021 at 04:00 am. The patient was pregnancy at time of vaccination. Pregnancy due date was 23Aug2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event exposure during pregnancy was unknown, of the other events was recovering. Information on the lot/batch number has been requested.
34 2021-05-15 vision blurred 2nd Dose: May 14 - severe muscle spasm in back beginning at 8pm, fever of 101, muscle aches and join... Read more
2nd Dose: May 14 - severe muscle spasm in back beginning at 8pm, fever of 101, muscle aches and joint pain throughout entire body, headache, fogginess in head, blurred vision in right eye, nasal congestion, bleeding nose, tickle cough, lightheadedness
34 2021-05-16 ear pain Developed ear pain evening of 4/21/2021 (side unknown), ear pain continued and worsened. Early AM on... Read more
Developed ear pain evening of 4/21/2021 (side unknown), ear pain continued and worsened. Early AM on 04/25/2021, developed facial drooping on same side as ear pain. Medical exam consistent with Bell Palsy. Grade !!!.Valtrex was prescribed along with eye drops.
34 2021-05-17 eye itchiness, bloodshot eyes, eye swelling Five days after pt received the second dose of Pfizer vaccine, she noticed redness, swelling & itchi... Read more
Five days after pt received the second dose of Pfizer vaccine, she noticed redness, swelling & itchiness on left eye & today it got worse, Pt took otc anti-allergy meds without effect.
34 2021-05-17 mouth numbness, ear discomfort Pressure in ears and dizziness. Intense pins and needles in hands and feet, legs and arms and face (... Read more
Pressure in ears and dizziness. Intense pins and needles in hands and feet, legs and arms and face (mostly lower face and lips) and neck and feeling of itchiness. 5/9 the ear pressure was less but the pins and needles/itchy feeling was still there. Currently I still have some ear pressure and pins and needles (less severe) in my hands and feet and sometimes moves to my arms and legs. A light sensation in my face. The other day the pins and needles were rather painful again but are back to being less severe.
34 2021-05-17 ringing in ears, visual impairment Within approximately five minutes of injection, felt hot, became flushed, heart racing, short of bre... Read more
Within approximately five minutes of injection, felt hot, became flushed, heart racing, short of breath, dizzy, ears ringing, seeing spots. Occurred over approximately ten minutes (best guess). Removed mask, fanned, lay down, closed eyes, was given water. As symptoms subsided, returned to a seated position. Remained at store approximately 45 minutes after injection to confirm able to drive home.
34 2021-05-17 vision blurred 6pm swelling and pain at injection site 7pm blurred vision & nausea 730pm increased injection arm p... Read more
6pm swelling and pain at injection site 7pm blurred vision & nausea 730pm increased injection arm pain 8pm right knee swelling and pain with sensation behind knee (caused me to limp and unable to bend knee) 935pm lower back, hip and neck pain as well as nasal congestion on my left side and head pressure Intermittent pin prick pain at seemingly random intervals throughout the day/night in right thumb, left index finger, right toe, left wrist. woke up next day (today) with continued blurred vision, neck pain and head pressure.
34 2021-05-18 eye swelling My eyes started to get swelled up; This is a spontaneous report from a contactable other HCP (patien... Read more
My eyes started to get swelled up; This is a spontaneous report from a contactable other HCP (patient). A 34-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6199, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 11Mar2021 16:15 as first dose single for covid-19 immunisation. Medical history included anaemia, high cholesterol (Under control) and Known allergies: aspirin. Concomitant medications included ascorbic acid (VITAMIN-C) and cholecalciferol (CALCIFEROL) both are taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccine in four weeks. On 11th March 2021 (The day patient received vaccine first dose) around 7:15pm, patient eyes started to get swelled up. Patient took Benadryl. Swelling decreased during the night. Then, in the morning, patient woke up with her eyes swollen again. patient took Benadryl once more. Around noon, swelling dismissed. As per the reporter seriousness criteria for the event reported as medically significant. The outcome of the event was recovered on an unspecified date in Mar2021. Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: As there is limited information in the case provided, the causal association between the event eye swelling and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
34 2021-05-18 lip swelling lips started swelling; can hardly talk; This is a spontaneous report from a contactable consumer (pa... Read more
lips started swelling; can hardly talk; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on Apr2021 as a single dose for COVID-19 immunization. Medical history included lip fillers, anxiety and depression all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient had no known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO); quetiapine fumarate (SEROQUEL) and spironolactone (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 27Apr2021, at 08:00 about 2 1/2 weeks the patient's first dose, her lips started swelling. They are now so swollen that the patient can hardly talk and was now going to urgent care. The patient received prednisone injection as treatment for the events. The events resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. The event were reported as non-serious. The patient recevied the second dose of bnt162b2 on Apr2021 on the left arm for COVID-19 immunization. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Lip swelling and speech disorder cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate
34 2021-05-19 ear discomfort Ear popping; Diaphoretic; Chills; Lightheadedness; This is a spontaneous report received from a cont... Read more
Ear popping; Diaphoretic; Chills; Lightheadedness; This is a spontaneous report received from a contactable healthcare professional. This healthcare professional (reporter) reported for a 34-year-old female patient, who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6205) on 16Mar2021 (at the age of 34-year) via an unspecified route of administration for COVID-19 Immunization. No medical history and concomitant medications were reported by the patient. Her past medical history included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; Unknown) on an unknown date via an unspecified route of administration for COVID-19 Immunization. On 16Mar2021, 15 minutes after vaccination, she experienced light-headedness. She denied rash, hives, shortness of breath. The patient complained of chills and ear popping and her appearance was diaphoretic. She also denied facial swelling, ear pain and runny nose. Her treatment for the events included snacks, prolonged observation and slow position changes. The follow up response to treatment was excellent. The patient was stable to go home and follow up with PCP however the clinical outcome for the reported events chills, ear popping, diaphoretic and light-headedness was unknown (as it was not specified). No follow-up attempts are needed. No further information is expected.
34 2021-05-19 ringing in ears Tinnitus after second does of vaccine. Became noticeable about 12 hours after 2nd dose was administe... Read more
Tinnitus after second does of vaccine. Became noticeable about 12 hours after 2nd dose was administered. Has been a persistent, high pitched frequency in my ears ever since.
34 2021-05-19 ringing in ears Significantly worse tinnitus (I would occasionally have mild tinnitus before - now it is constant an... Read more
Significantly worse tinnitus (I would occasionally have mild tinnitus before - now it is constant and loud)
34 2021-05-19 ringing in ears Tinnitus; one week after second dose. Tinnitus has not resolved.
34 2021-05-21 eye pain, sensitivity to light After the 1st dose I had an extremely severe headache within 4 hours, light sensitivity and eye pain... Read more
After the 1st dose I had an extremely severe headache within 4 hours, light sensitivity and eye pain . For the next 72 hours I had severe body aches, chills, intense joint pain (starting at ankles, knees, femurs and then hips. Radiating pain in each section about 30 minutes at a time). Sweating at night. I was light headed and had extreme fatigue. The first 4 nights I had extreme stomach pain all over from under my rib cage felt it moving through my entire stomach track. Even my uterus hurt and I had intense diarrhea, always occurring after 1am but no later than 5am. For a week after the first dose i continued to experience side effects, but not as intensely. Mostly severe fatigue, headache, sensitivity to light, eye pain, muscle stiffness and diarrhea. Yesterday i received my 2nd dose and initially only experienced a slight headache and moderate fatigue. But at 2am I awoke with EXTREMELY INTENSE pain in my kidney area and lower back. It felt very similar to my stomach pain in that there was a throbbing and a sensation of squeezing of the kidneys and surrounding muscles. The pain was so acute that it affected my breathing patttern and now the morning after my lower back muscles are very sore, indicating there was a physical component to the 2am incident that affected the lower back and kidney area.
34 2021-05-21 vision blurred, blindness transient passed out; loss of vision for a few minutes; Dizziness; blurred vision; Severe weakness; couldn't w... Read more
passed out; loss of vision for a few minutes; Dizziness; blurred vision; Severe weakness; couldn't walk; chills; fever; Fatigue; soreness in right arm; muscle aches; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 05May2021 15:00 (Lot Number: ew0161) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient had no other medical history. Concomitant medications included ethinylestradiol, norgestimate (TRI LO MARZIA); ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL); probiotics (PROBIOTICS) all taken for an unspecified indication, start and stop date were not reported. The patient received first dose of Covid-19 vaccine (manufacture Pfizer, lot number ew0151) on 14Apr2021 01:00 PM in Left arm for covid-19 immunisation. The patient experienced dizziness with blurred vision / loss of vision for a few minutes, possibly passed out. Severe weakness, couldn't walk for a few minutes. Dizziness with chills/fever lasted a few hours. Fatigue for 12 hours. Soreness in right arm and muscle aches all over. Headache for 12-16 hours, all on 06May2021 06:30 with outcome of recovered. No treatment was received for the events. Information on the lot/batch number has been requested.; Sender's Comments: The causal association between the reported events passed out and loss of vision for a few minutes and the suspect drug BNT162B2 cannot be totally excluded based on a temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
34 2021-05-21 eye floaters, light flashes or floaters in the eye, vision blurred Sudden appearance of significant amount of eye floaters, flashes and blurriness in the right eye abo... Read more
Sudden appearance of significant amount of eye floaters, flashes and blurriness in the right eye about 20 hours after the 2nd shot of Pfizer Covid-19 vaccine. First started to notice sporadic floaters and mild blurriness during the 3-week period between the 1st and the 2nd shot of Pfizer vaccine. Diagnosed with Central Retinal Vein Occlusion (CRVO) with macular edema in the right eye within 48 hours of the 2nd shot of the vaccine. Confirmed by second opinion. Right eye vision is currently 20/50. Received Eylea injection in the right eye. Antiphospholipid panel, Protein S, Protein C, Factor V, Homocysteine and Antithrombin all come back normal from lab testing. Blood pressure normal, no diabetes, no known systematic disease. 34 year old female.
34 2021-05-23 ringing in ears 5/7/2021: 2 am-4 am, 102F fever; chills; sweating; vomiting. 4 am - low temp 95F, intense malaise. 8... Read more
5/7/2021: 2 am-4 am, 102F fever; chills; sweating; vomiting. 4 am - low temp 95F, intense malaise. 8 am-8 pm, diarrhea; severe vertigo; tinnitus; fainting. 5/8/2021-5/20/2021: Mobility issues from recent vertigo attack; several more vertigo attacks throughout the week; poor concentration; vomiting; tingling throughout body; fatigue; insomnia; enhanced anxiety. 5/20/2021-5/24/2021: Delayed cycle (extra 5 days and counting). All symptoms from 5/8 to 5/20 continue at half severity.
34 2021-05-25 loss of taste, mouth numbness, mouth tingling Tingling/Fizzing/ numbing in face, gums, lips, nose, hands, feet and leg.; Tingling/Fizzing/ numbing... Read more
Tingling/Fizzing/ numbing in face, gums, lips, nose, hands, feet and leg.; Tingling/Fizzing/ numbing in face, gums, lips, nose, hands, feet and leg.; Numbing in face, nose, hands, feet and leg.; Numbing in gums, lips; Lose of taste; Arms are having burning/hot sensation.. icy/hot feeling; Arms are having burning/hot sensation.. icy/hot feeling; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administered in Arm Left on 30Apr2021 11:15 PM as 1st dose, single for covid-19 immunisation. Patient medical history included hypothyroidism from an unknown date and unknown if ongoing. Patient Concomitant medications included Levothyroxine taken for an unspecified indication, start and stop date were not reported. Patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In hospital the most recent COVID-19 vaccine was administered. The patient experienced Tingling/Fizzing/ numbing in face, gums, lips, nose, hands, feet and leg. This has continued one week after vaccine. Lose of taste the day after vaccine, taste came back & then went away once again, then finally came back. Today the numbing and tingling has slowed down but now both my arms are having burning/hot sensation. icy/hot feeling on 30-APR-2021 10:30 PM. The events assessed as non-serious. No treatment was received for the events. The patient visited doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was reported for Lose of taste as recovered on unknown date and while for others was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained
34 2021-05-25 loss of taste received 1st dose of Pfizer COVID vaccine on 12/22/20 and 2nd dose on 1/12/21, lost taste and smell ... Read more
received 1st dose of Pfizer COVID vaccine on 12/22/20 and 2nd dose on 1/12/21, lost taste and smell on 5/24/21, tested positive from community on 5/26/21
34 2021-05-25 eye disorder, conjunctivitis Dx Headache ? Sore Throat ? Fever ? Eye Problem ? Cough ? Covid-19 Screening ? Nasal Congestion ... Read more
Dx Headache ? Sore Throat ? Fever ? Eye Problem ? Cough ? Covid-19 Screening ? Nasal Congestion Sore throat Acute nonintractable headache, unspecified headache type Fever, unspecified fever cause Cough Nasal congestion with rhinorrhea At increased risk of exposure to COVID-19 virus Conjunctivitis due to COVID-19 Vagal reaction
34 2021-05-26 mouth numbness, loss of taste this is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant fe... Read more
this is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot/batch number: SDPHO EN6206), Dose: 1 via an unspecified route of administration in the left arm on 11Mar2021 at 11:00 AM (at the age of 34-years-old), as a single dose for COVID-19 Immunization. The patient was allergic to latex, curry, nickel and other alloys. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient was not receiving any concomitant medications. The patient did not receive any vaccine within 4 weeks prior to the COVID-19 vaccine. On 11Mar2021 at 21:00, the patient experienced new loss of taste and tongue numbness. The patient underwent lab test on 15Mar2021 which included polymerase chain reaction via a nasal swab and the test result was negative. The patient did not receive any treatment for the adverse events. The clinical outcome of new loss of taste and tongue numbness was recovering. No follow-up attempts are needed. No further information is expected.
34 2021-05-27 lip swelling minor swelling of my lips, hands, feet; minor swelling of my lips, hands, feet; extreme fatigue; a f... Read more
minor swelling of my lips, hands, feet; minor swelling of my lips, hands, feet; extreme fatigue; a feeling of tightness and some difficulty swallowing in my throat; a feeling of tightness and some difficulty swallowing in my throat; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-preganant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm at the age of 34-year-old on 15May2021 16:30 (Batch/Lot Number: EW0185) as single dose for covid-19 immunisation. Medical history included seasonal allergies, asthma, gastrooesophageal reflux disease(GERD). Concomitant medications included spironolactone; fexofenadine hydrochloride (ALLEGRA); mometasone furoate (FLONASE); omeprazole magnesium (PRILOSEC), all the medications received from 2021 (within 2 weeks of vaccination). The patient previously took sulfa and doxycycline. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm at the age of 34-year-old on 17Apr2021 18:00 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient woke up the next day with minor swelling of her lips, hands, feet, and a feeling of tightness and some difficulty swallowing in her throat. The swelling receded with a non drowsy antihistamine but the feeling of extreme fatigue and a histamine reaction continued. No treatment received for events a feeling of tightness and some difficulty swallowing in her throat. The start date of all events was on 16May2021 08:00 and no hospitalization prolonged. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.
34 2021-05-28 loss of taste, loss of smell One day following the Covid vaccine [second dose in two part series], slight loss of smell has prese... Read more
One day following the Covid vaccine [second dose in two part series], slight loss of smell has presented. The loss if smell in particular was noted related to a daily fermented grain that usually displays a sour fermented smell. Though said patient could not smell the sour odor, another household member could smell it [said household member was also vaccinated with the second Pfiezer Covid vaccine dose the same day]. Reporting patient maintains other normal sense of smell and taste thus far.
34 2021-05-29 sensitivity to light Migraines (aura, sensitivity to light and sound, confusion, extreme tiredness, nausea) resembling se... Read more
Migraines (aura, sensitivity to light and sound, confusion, extreme tiredness, nausea) resembling seizures every two weeks starting April 19th. 5 days after first dose.
34 2021-05-31 loss of taste, loss of smell Dx loss of taste ? loss of smell ? Nasal Congestion GRAVIDE PARA: G 3 P 1 1 0 2 EDD: 08/19/2021
34 2021-06-01 ear pain Right after the shot I felt tired and a mild headache formed. However on May 29th in the evening, I ... Read more
Right after the shot I felt tired and a mild headache formed. However on May 29th in the evening, I became very very cold and my teeth were chattering very hard! Since then the fatigue has only increased, muscle soreness and my muscles have little strength as though I've done an intense workout and lactic acid has built up in the muscles causing fatigue. It might have been Monday or Tuesday when I felt pain in one ear and then the next. I have experienced sharp pain in my chest today. I had clear stool after getting the shot and diarrhea, which resolved. But today I have diarrhea again.
34 2021-06-01 pain in jaw Severe jaw pain. Went to the dentist and said everything was okay.
34 2021-06-03 ear pain Besides the body ache, headache, and sore muscles, I had bad earaches and hives. the hives have gott... Read more
Besides the body ache, headache, and sore muscles, I had bad earaches and hives. the hives have gotten worse on the second day and keep spreading around. i've tried to take an antihistamine, but I'm not sure if it's working. I am waiting another day or two before heading to the doctors but I wanted to report the EARACHES and HIVES.
34 2021-06-03 visual impairment decreased ability to make decisions; Dizziness similar to vertigo;dizziness set in maybe 48 hours af... Read more
decreased ability to make decisions; Dizziness similar to vertigo;dizziness set in maybe 48 hours after my second dose and worsened over the following week; Dizziness similar to vertigo;dizziness set in maybe 48 hours after my second dose and worsened over the following week; was stimulated by movement, visual changes, and sounds independent of each other; was stimulated by movement, visual changes, and sounds independent of each other; Brain fog; inability to focus my attention; confusion as well as decreased ability to make decisions; Anxiety that was severe/Heightened anxiety levels have remained for almost a week; describe as a severe panic attack; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0179) as single dose for covid-19 immunisation at the age of 34-year-old. Medical history included ADHD, allergy to Bactrim. She has felt dizziness when had the middle ear suctioned out while having a tympanostomy. The patient previously received the dose 1 administered in Arm Left on 16Apr2021 (Batch/Lot Number: EW0161) as single dose for covid-19 immunisation at the age of 34-year-old. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and sertraline hydrochloride (ZOLOFT). On 09May2021, the patient experienced dizziness that similar to vertigo, that was stimulated by movement, visual changes, and sounds independent of each other. The only time I've felt similar dizziness is when I've had my middle ear suctioned out while having a tympanostomy. The dizziness set in maybe 48 hours after my second dose and worsened over the following week and then started to lessen; also felt brain fog that included inability to focus my attention, switch between tasks effectively, and confusion as well as decreased ability to make decisions. This brain fog has lasted well over a week now but is starting to abate; and also experienced anxiety that was severe. A week after my second dose, I had what I can only describe as a severe panic attack. I have never had one this severe and have not had a panic attack in well over a decade. The panic attack was not preceded by any event that I would characterize as outside the realm of normal levels of stress. Heightened anxiety levels have remained for almost a week now but are slowly dissipating. The outcome of the events was recovering. No treatment received for the events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.
34 2021-06-06 dry throat Immediately after the vaccination, patient reported feeling an itchy face + arms, tired, and dry thr... Read more
Immediately after the vaccination, patient reported feeling an itchy face + arms, tired, and dry throat. Well appearing at time of incident. No rashes.
34 2021-06-06 lip swelling Swelling of bottom lip, increased swelling on the left side. I woke up to the swelling 2 days after ... Read more
Swelling of bottom lip, increased swelling on the left side. I woke up to the swelling 2 days after the vaccine. It could have possibly been swollen through the night while sleeping. Benadryl alleviated the swelling.
34 2021-06-06 eye discomfort, deafness unilateral, ringing in ears Tinnitus began in right ear on 4/29/21 followed by sudden hearing loss in the same ear. Visited ENT ... Read more
Tinnitus began in right ear on 4/29/21 followed by sudden hearing loss in the same ear. Visited ENT on 5/11 and 5/13 and was diagnosed with sudden hearing loss and treated with steroids for 12 days. Hearing mostly (85%) recovered however tinnitus began in left ear on 5/17/21. Subsequently, further tingling and numbness in limbs has continued along with increased eye pressure.
34 2021-06-07 mouth tingling Tingling lips and tongue; tingling body sensation in skin; hives; rash; shortness of breath; dizzine... Read more
Tingling lips and tongue; tingling body sensation in skin; hives; rash; shortness of breath; dizziness; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6201), via an unspecified route of administration, on 03Mar2021 11:00 (at age of 34-year-old) as single in Arm Left for covid-19 immunization. The patient's medical history included allergies to coconut sunflower, and cats and dogs. No covid prior vaccination and has not tested covid post vaccination. The patients concomitant medications included quetiapine (SEROQUEL) and diphenhydramine hydrochloride (CETIRIZINE). On 06Mar2021 16:00, the patient experienced tingling lips and tongue, tingling body sensation in skin, hives, rash, shortness of breath, and dizziness. The outcome of all events were not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
34 2021-06-07 taste disorder, eye pain The night after the shot, I have extremely vivid and lucid dreams. The following week on June first,... Read more
The night after the shot, I have extremely vivid and lucid dreams. The following week on June first, I notice that the texture of food felt different. I was still able to taste, but my tongue felt numb, almost. On June 3, my eye began to hurt...like I had something in it. I added a couple eye drops and took some Advil, and that seemed to work. On June 4th, my eye became worse, and eye drops were not helping. On the morning of June 5th, I noticed my smile was off and I could not drink out of a straw properly. Food textures were still off and my eye was much worse. I went to the Urgent Care, and they advised me to go to the ER to rule out anything neurological. The symptoms I was and still am experiencing, and was diagnosed with was Bell's Palsy. I have never had this happen before and rarely get sick. During this time I have had not other illness.
34 2021-06-07 taste disorder Within 5-10 mins had burning in my chest/throat and awful taste in my mouth. Stiff arm & neck withi... Read more
Within 5-10 mins had burning in my chest/throat and awful taste in my mouth. Stiff arm & neck within an hour, hives all over. Heart racing. Severe headache. After calling 811 of concerns of the burning in my chest/throat not going away they advised calling an ambulance.
34 2021-06-07 ringing in ears, ear discomfort 5/10/21-25/12/21: dizziness, fatigue, headache 5/15/21, onward: ear fullness 5/22/21, onward: sudden... Read more
5/10/21-25/12/21: dizziness, fatigue, headache 5/15/21, onward: ear fullness 5/22/21, onward: sudden tinnitus 5/26/21, onward: dizziness, tinnitus, ear fullness
34 2021-06-08 canker sore sore left eye lid/ bump on lid/ irritation in corner of eye; canker sore on left side of tongue; cys... Read more
sore left eye lid/ bump on lid/ irritation in corner of eye; canker sore on left side of tongue; cystic acne on left shoulder; This is a spontaneous report from a contactable consumer or non-HCP. A 34-year-old female patient received BNT162B2 (Pfizer BIONTECH COVID 19 mRNA Vaccine; lot number EN6208 as a second dose administered in arm Left for COVID-19 immunisation on date 13Mar2021 at 12 pm( patient is 34 years of age at the time of vaccination). Medical history was not reported. Concomitant medication was not reported. On 20Feb2021 at 1pm,patient received BNT162B2(Pfizer BIONTECH COVID 19 mRNA Vaccine; lot number EL9264, as 1st dose on left arm. No allergies to medications, food, or other products. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 16Mar2021, patient experienced canker sore on left side of tongue, cystic acne on left shoulder and sore left eye lid/ bump on lid/ irritation in corner of eye. No therapeutic measures were taken. The clinical outcome of the events canker sore on left side of tongue, cystic acne on left shoulder and sore left eye lid/ bump on lid/ irritation in corner of eye was not recovered.
34 2021-06-08 eye itchiness I started having heart palpations on site after I received the vaccine, I had an EKG on site. The re... Read more
I started having heart palpations on site after I received the vaccine, I had an EKG on site. The results from the EKG were normal and I was advised that I would be ok to go. I later that night noticed my left arm, shoulder, and side were swelling. I propped my left arm up due to the swelling and pain. I went back to sleep and the swelling finally went away after 6 hours. Whenever I woke up, I was fine, and the swelling went away. I also had itchy eyeballs for weeks on and off, joint pain, and fatigue.
34 2021-06-08 lip swelling On day 7 after my second dose of the covid vaccine I woke up covered with hives. From that day on I ... Read more
On day 7 after my second dose of the covid vaccine I woke up covered with hives. From that day on I have had full body hives and angioedema everyday. I have been to multiple doctors ( general practice, allergists, dermatologist and rheumatologist) I have had 2 ER visits because my lips and face swell at times. No one has any idea on how to treat my condition. I have been on multiple antihistamines as well as 2 rounds of oral steroids and 2 steroid injections. nothing helps. I have had multiple blood draws and everything comes back normal other than CRP and ESR are both elevated. I have also had a skin biopsy that showed hives with no vasculitis.
34 2021-06-09 pain in jaw Myocarditis. Pain in chest, left arm and both sides of jaw. Lasted for about 10 minutes.
34 2021-06-09 sensitivity to light, extreme sound sensitivity Swollen breasts -used ice packs to cool down.. 2 days post vaccine they are still swollen Started me... Read more
Swollen breasts -used ice packs to cool down.. 2 days post vaccine they are still swollen Started menstrual cycle around 1am next morning.. I haven't had a cycle in 5 years. I'm on extended birth control. Induced a migraine - used OTC Excedrin Body aches, chills, aching skin, Sensitivity to light and sound
34 2021-06-09 visual impairment, vision blurred, swollen tongue Client reports on 6/9/21 that 3 days after first dose she experienced seeing black dots, blurred vis... Read more
Client reports on 6/9/21 that 3 days after first dose she experienced seeing black dots, blurred vision, neck pain that radiated to her head , dizziness and tongue swelling that lasted 2 hours. Client reports she never had shortness of breath. No history of chronic conditions, no medications taken . Client did not follow up with pcp. Client reports going to the emergency room and that everything was fine except her blood sugar was low.
34 2021-06-10 visual field defect Attendee became suddenly lightheaded flt hot, diaphoretic, felt "faint, had peripheral "dark vision"... Read more
Attendee became suddenly lightheaded flt hot, diaphoretic, felt "faint, had peripheral "dark vision", refused to lie on cot, instead lid down on the floor with her feet up on chair. Vital signs in normal range - remained under observation x30 minutes, then left with her husband.
34 2021-06-12 lacrimation increased After receiving the second shot of covid vaccine (pfizer), the patient started experiencing severe p... Read more
After receiving the second shot of covid vaccine (pfizer), the patient started experiencing severe pain on the right side of her head. Her eye shut closed, and she couldn't keep it open. Her eye was also watery. She then started experiencing difficulty breathing and chest tightness. She was also sweating.
34 2021-06-12 vision blurred I took my first Pfizer dose vaccine on April-20-2021, after that I had dizziness along with blood pr... Read more
I took my first Pfizer dose vaccine on April-20-2021, after that I had dizziness along with blood pressure fluctuation, first it was high and then low to normal in 10 minutes interval and dizziness continued for a week I took 2nd dose on May-11-2021 and then I felt dizzy with mild abdomen pain, and pain got severe. On day 3 onwards I had heavy back pain and stabbing pain in the middle of the chest that continued for next 2 days. On day 5 pain was intolerable chest pain& shortness of breath and I visited Emergency care for the treatment at midnight with the pulse rate of 145 ( checked at home) took EKG, blood test and chest X-ray. But in blood test D-dimer was normal after 2 hrs in emergency care I was discharged with same level of pain. Next day visited Primary care to seek the consultation and she advised to take the CT scan but the pain got severe. Again I went to ER, this time D-Dimer was higher(2 times) than previous day. So they took the CT scan to ruled out Pulmonary embolism. But ER doctor doubted Bronchial wall thickening which may reflect bronchitis or reactive airvey disease. On day 7 I had numbness on my right side and felt tingling sensation on my chin with blurred vision, dizziness, heavy headache with visible veins. After all the test, Primary care told I had costochondritis because of the irritation caused by vaccine. I'm yet to visit eye and neurologist to check the other symptons. Though I was normal before as I took the full body checkup which was clear, because of this vaccine I have these adverse side effects which affects my daily activities. I can provide the documents if needed.
34 2021-06-12 visual field defect Felt hot, lightheaded, diaphoretic, felt faint, peripheral vision darkness..
34 2021-06-13 dry mouth, dry throat "Pt has a hx of anxiety. Pt c/o dry throat and mouth @11:30AM, 15mins post vaccination. BP 120/82, ... Read more
"Pt has a hx of anxiety. Pt c/o dry throat and mouth @11:30AM, 15mins post vaccination. BP 120/82, HR 81, RR 20. Pt had not eaten yet. A&Ox3. Pt stable and released from the vaccination site @11:40 w/ sister to go get lunch.."
34 2021-06-14 inability to speak Hoarseness, loss of voice, and phlegm starting the day following the second vaccine. Difficult to c... Read more
Hoarseness, loss of voice, and phlegm starting the day following the second vaccine. Difficult to clear throat, phlegm has persisted for the past week, now leading to a persistent fits of coughing starting today.
34 2021-06-14 taste impairment Chronic constant Metallic taste in mouth for 2 weeks since injection given.
34 2021-06-14 eye swelling, eye pain Saturday morning , 1/30/2021 my left eye became red, and was very painful by Sunday, 1/31/2021. My e... Read more
Saturday morning , 1/30/2021 my left eye became red, and was very painful by Sunday, 1/31/2021. My eye had a red spot with yellowish veins to the left of my pupil, and it felt inflamed and swollen. Made an appt. with Dr., my eye doctor, for Monday 2/1/2021 and was diagnosed with Episcleritis and prescribed steroid eye drops. Dr. explained the cause of Episcleritis is somewhat unknown, but it's an inflammatory reaction that's not uncommon for people with other auto-immune concerns. He was unsure if the Episcleritis was caused by the COVID-19 Vaccine, but advised me to report it to the specific app, so I did. I did NOT have another reaction after the second shot.
34 2021-06-14 tongue itchiness Name: DOB: Phone: PMH: denies ALL: denies VS: 97%, HR 80, BP 170/104 (immediately after epi, then ... Read more
Name: DOB: Phone: PMH: denies ALL: denies VS: 97%, HR 80, BP 170/104 (immediately after epi, then 148/94 20 minutes later) Symptoms: No medical history or allergies. This is Dose#2 and had immediate wretching, nausea, with spitting up phlegm and gasping. No oropharyngeal swelling but felt tongue itching, shortness of breath and had left sided wheezing with decreased air entry. Assessment: In distress, gasping/wretching, left sided wheezing with decreased air entry and normal Treatment: 0.3mg epinephrine autoinjector50mg IM benadryl x1 albuterol inhaler x 3 puffsPatient felt jittery but clear airway, no SOB, no nausea.EMS was called, assessed by PGFD and recommended ED for observation but the patient refused transport (signed with EMS to refuse transport). She asked to be allowed to rest on site and then go home. Remained on site with in-car observation for 2 hours and resolution of symptoms.Drove herself home.
34 2021-06-15 lacrimation increased Pain in the tonsils tiredness headache and dizziness and itchy nose and watery eyes.
34 2021-06-15 ringing in ears I got the vaccination on 3/31/2021 at about 9 AM. At about 7 PM that evening, my ears got plugged an... Read more
I got the vaccination on 3/31/2021 at about 9 AM. At about 7 PM that evening, my ears got plugged and I had ringing in them. I had fever, extreme chills, and extreme tiredness. I still have a constant, very loud ringing in my ears. The ringing has gotten louder over time.
34 2021-06-16 ear pain experienced extreme pain for 12 days following the injection, in her entire arm/ pain continued to s... Read more
experienced extreme pain for 12 days following the injection, in her entire arm/ pain continued to spread down her arm and to her hand; experienced extreme pain for 12 days following the injection, in her entire arm, shoulder, neck, up to her left ear, and sharp shooting pains throughout her back; experienced extreme pain for 12 days following the injection, in her entire arm, shoulder, neck, up to her left ear, and sharp shooting pains throughout her back; experienced extreme pain for 12 days following the injection, in her entire arm, shoulder, neck, up to her left ear, and sharp shooting pains throughout her back; experienced extreme pain for 12 days following the injection, in her entire arm, shoulder, neck, up to her left ear, and sharp shooting pains throughout her back; dose 1 subcutaneously, administered in left arm; discomfort; could not move her neck or arm due to pain; could not move her neck or arm due to pain; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 15Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from contactable consumers (one of them was patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EC3302), dose 1 subcutaneously, administered in left arm on 22Jan2021 08:09 (at the age of 34-year-old) at 0.3 ml as single dose for COVID-19 immunization. Medical history included MTHFR C677T/A1298C mutations from Mar2018 and ongoing (onset date unknown, was diagnosed after positive lab results in Mar2018). The patient's concomitant medications were not reported. Additional vaccines administered on same date of the Pfizer Suspect, Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations were reported as not applicable. Patient stated, first dose injection was administered subcutaneously (22Jan2021 08:09) on left arm; experienced extreme pain for 12 days following the injection, in the entire arm, shoulder, neck, up to left ear, and sharp shooting pains throughout her back (starting around 14:00 on the day of the injection). The patient went to the ER (emergency room) 3 days post injection and was told to take ibuprofen until the pain subsided. Ibuprofen did not relieve any pain. Patient again stated, on 25Jan2021, went to the ER because the pain continued to spread down her arm and to her hand. She could not move her neck or arm due to pain. The ER doctor confirmed the injection site was subcutaneous and that was causing an unexpected reaction. The patient was told to take ibuprofen around the clock until the pain goes away so she tried for about 36 hours, but there was no relief. She experienced the extreme pain and discomfort for 12 days, until 03Feb2021 a week (and 2 days) prior to her second dose. Patient was not hospitalized. No other product(s) were not taken together. Patient visited Emergency Room and not visited Physician Office (communicated with Primary Care Physician over email, following ER visit). The patient would like to have an antibody test, so queried to advise how she can arrange that, and also reported that she donated blood, but their antibody tests for a different type of antibodies from actually having covid, not from getting the vaccine so her results were negative. Hopefully can arrange for the correct type of antibody test. The outcome of events 'experienced extreme pain for 12 days following the injection, in her entire arm, shoulder, neck, up to her left ear, and sharp shooting pains throughout her back', 'experienced extreme pain for 12 days following the injection, in her entire arm/ pain continued to spread down her arm and to her hand', 'could not move her neck or arm due to pain' and discomfort was reported as resolved on 03Feb2021. No follow-up attempts are needed. No further information is expected Amendment (16Jun2021): This follow-up report is being submitted to amend previously reported Information: removed the classification of at risk from the general tab.
34 2021-06-16 mouth discomfort, mouth ulceration, burning mouth syndrome, canker sore, lip redness, oral mucosal blistering cold sore; blister; canker; experienced sores in some parts of the tongue; lips felt like it got sun... Read more
cold sore; blister; canker; experienced sores in some parts of the tongue; lips felt like it got sun burned; mouth ulcers; Tested positive for HSV-1 antibody test./they can see if she has the HSV1 antibody/she took the test and she was positive, she does have the antibodies; Sometimes they feel kind of warm and some have been on her tongue too; little red areas and has had 24 different little red areas on lips; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: ER8731), via an unspecified route of administration in left arm in the shoulder area on 22Apr2021 at 1200 or 12:15 in the afternoon, (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medication was not reported. Patient had previously reported first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EP7533) on 01Apr2021 as a single dose for COVID-19 immunisation. No additional vaccines administered on same date of suspect. Patient did not receive other vaccine in four weeks of vaccination. As reported patient was taking COVID vaccine because she thinks that it was the right thing to do. On 02May2021, patient experienced little red areas and has had 24 different little red areas. Patient started getting red areas on lips (got in about 24 of this over the past few weeks). After getting second shot, started getting 3 spots in the morning, 2 spots in the evening, some spots go away after a few days, but some spots appear in some other areas of the mouth. It was as similar to blister, cold sore, and canker. Also experienced sores in some parts of the tongue and lips felt like it got sun burned. Her symptoms were pretty mild, but she did not know if mouth ulcers and things like that were being recorded or not. 10 days after her 2nd dose she started getting- she did not know what the correct word was for this part of the lip, but it was where you put lipstick on where your lip skin and the mouth skin meet but that area that lipstick did not stick to these little red areas and she had 24 different little red areas. Sometimes they feel kind of warm and some have been on her tongue too and some were like a tiny blister and then in the morning it was gone. None have cracked, scabbed or nothing like that but they keep coming and her doctor prescribed her valaciclovir hydrochloride (VALTREX) thinking that they were cold sores but that did not do anything. Sometimes she would have three and then by the end of the day she would have 2. She had 2 in different parts of her mouth and sometimes they were going all over the place. She had one on her tongue yesterday but her lips were looking good so she thought that it was getting better because of the valaciclovir hydrochloride (VALTREX) since her primary care doctor thought that it could be cold sores. So, patient thought well it must be cold sores and the valaciclovir hydrochloride (VALTREX) was working but then she had a new one and she thought, what the heck, and woke up with 4 others this morning. She was not had all 24 at the same time, but they change throughout the day. The only thing that was different in her life between that time was the second dose. She had been experiencing the sores for a few days, saw her primary care doctor. She did have the antibodies, but her doctor said that just because she had the antibodies did not mean that she had cold sores that were active. On an unknown date, tested positive for HSV-1 antibody test. Patient took valaciclovir hydrochloride (VALTREX) 2 pills in the morning and 2 pills in the evening with the hoped to remedy the oral condition however the mouth sores still appeared. Product Complaint included reporting adverse event after her COVID vaccine and said that her doctor prescribed her valaciclovir hydrochloride (VALTREX) thinking that they were cold sores but that did not do anything. She took it for 1 day, 2 pills in the morning and 2 pills in the evening, to see if it would work itself out and she was hopeful it was working but then it did not, so she was seeing a dermatologist tomorrow for it. She thought at one point that the VALTREX was working when her lips had cleared up a bit, but then she had a new one and she thought, what the heck, and woke up with 4 others this morning. Probed for NDC, lot number and expiry date for the Valtrex and caller said that she threw it out so unable to provide any further information. Adverse events did not require a visit to emergency room. Patient visited physician office to see her primary care doctor and spoke to her dentist and they had referred her to an oral surgeon but they could not see her until Sep2021 but she did call the dentist to see if this had been reported to them before. She was going to see the dermatologist tomorrow. Patient most recent bloodwork looks phenomenal but was borderline anaemic a little bit. Reporter seriousness for little red areas and had 24 different little red areas was unspecified. The outcome for event little red areas and has had 24 different little red areas was not recovered and for other events was unknown. No follow-up attempts are needed. No further information is expected.
34 2021-06-17 swollen tongue About 12 hours after receiving the 2nd dose vaccine, I woke up with severe chills. I felt very cold... Read more
About 12 hours after receiving the 2nd dose vaccine, I woke up with severe chills. I felt very cold, dizzy, light headed, swelling at injection site, body aches and pain, headache and no fever. I took Tylenol. I slept most of the day and went to see my doctor the next day and I was having symptoms of tightness in my throat and my tongue was swelling. The doctor advise to keep an eye on it. The chills lasted a few hours after onset but the aches and pain resolved after 3 days.
34 2021-06-20 dry mouth Events were over the course of 4 days as follows: May 14: migraine - overcame with rizatriptan May ... Read more
Events were over the course of 4 days as follows: May 14: migraine - overcame with rizatriptan May 15: migraine - overcame with rizatriptan May 16: woke up with dehydration, dry mouth, and cold sweat followed by: vomiting, extreme fatigue, very strong migraine; unable to overcome with rizatriptan and Aleve May 17: continued to recover from May 16's migraine and met with doctor; migraine eventually went away on its own around late afternoon; doctor prescribed Propranolol for migraine treatment and I started taking Propranolol the next day
34 2021-06-24 lip itchiness Pfizer-BioNTech COVID-10 Vaccine EUA. After receiving the 1st dose of Pfizer vaccine, patient experi... Read more
Pfizer-BioNTech COVID-10 Vaccine EUA. After receiving the 1st dose of Pfizer vaccine, patient experienced itchiness of her upper lip. Vital signs included BP 117/77, P 80, O2 99%. Cetirizine 10mg PO administered at 12:54. Patient denied SOB, trouble breathing, swallowing or symptoms of anaphylaxis. Patient had no additional or worsening symptoms before leaving the clinic.
34 2021-06-24 swollen tongue, eye swelling Swollen eyes and tongue; Swollen eyes and tongue; dizzy; weak; This is a spontaneous report from a c... Read more
Swollen eyes and tongue; Swollen eyes and tongue; dizzy; weak; This is a spontaneous report from a contactable other hcp. A 34-years-old female patient received second dose bnt162b2 (BNT162B2,Solution for injection,Batch/Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 03Feb2021 10:45 as 2ND DOSE, SINGLE for covid-19 immunisation. Patient didn't received another vaccination prior to covid vaccination with in 4 weeks, Patient didn't had Covid prior to vaccination. Medical history included cardiac disorder from an unknown date and unknown if ongoing ,food allergy from an unknown date and unknown if ongoing patient had received first dose bnt162b2 (BNT162B2,Solution for injection, Batch/Lot Number:EK9231), via an unspecified route of administration, administered in Arm Left on 11Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported, patient didn't got tested prior to post vaccination. On 03Feb2021 11:00 the patient experienced swollen eyes and tongue, dizzy and weak. The outcome of the events swollen eyes and tongue, dizzy, weak was not recovered. Follow-up attempts are completed. No further information is expected.
34 2021-06-25 ringing in ears Dizziness; Vertigo; Headaches; Tinnitus off and on for 9 weeks, and I'm still suffering; This is a s... Read more
Dizziness; Vertigo; Headaches; Tinnitus off and on for 9 weeks, and I'm still suffering; This is a spontaneous report from a non-contactable consumer (patient). A 34-years-old female patient received first dose of bnt162b2 (BNT162B2; Solution injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in Arm Left on 11Apr2021 12:00 as single dose (at the age of 34-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took oxycodone. On 14Apr2021 07:00, 3 days after first vaccine shot, patient experienced dizziness, vertigo, cluster headache, tinnitus off and on for 9 weeks, and I m still suffering. The events were reported as disability or permanent damage. She received antibiotics treatment but didn't work. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient been not been tested for COVID-19. The patient underwent lab tests and procedures which included blood test which was normal. The outcome of the all the events were not recovered. Follow-up attempts are not needed as the reporter is a non-contactable. No further information is expected.
34 2021-06-25 eye floaters, vision blurred, ringing in ears 4/20: Vaccine 2nd dose 4/23: Face and neck pustules / rash 4/24: Betamethosone topical cream prescri... Read more
4/20: Vaccine 2nd dose 4/23: Face and neck pustules / rash 4/24: Betamethosone topical cream prescription 4/25: doxycycline oral prescription (10 days) 5/12: Tinnitus onset 5/14: Ear fullness onset (right ear) 5/17: Ear flush by doctor 5/17: Prednisone 40mg (5 days) 5/20: blurred eye and floaters onset (right eye) As of 6/25, tinnitus, ear fullness and blurred eye remain.
34 2021-06-28 hearing loss Partial deafness on her right ear; This is a spontaneous report from a contactable consumer (patient... Read more
Partial deafness on her right ear; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Rx 1420942-00), via an unspecified route of administration in right arm, on 12May2021 at 03:15 PM (15:15) (at the age 34 years), as dose 1, single, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 14May2021, the patient felt partial deafness on her right ear for several weeks. The adverse event resulted in disability or permanent damage. No treatment was administered for the event. Since the vaccination, the patient has not been tested for COVID-19. At the time of last observation, the patient had not recovered from the event.
34 2021-06-30 ear discomfort Flu like symptomss; congestion; runny nose; body aches; sore throat,; sinus pain; POPPING EAR; This ... Read more
Flu like symptomss; congestion; runny nose; body aches; sore throat,; sinus pain; POPPING EAR; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) as unknown dose on 20Mar2021 at 10:15am for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 21Mar2021 at 08:00, the patient experienced flu like symptoms, congestion and runny nose, sore throat, body aches, headache, sinus pain and popping ears. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received any treatment for the reported events. The clinical outcome of the events flu like symptoms, congestion and runny nose, sore throat, body aches, headache, sinus pain and popping ears was not resolved. No follow-up attempts are possible. Information about lot number cannot be obtained.
34 2021-07-01 mouth tingling, mouth numbness A bad cough; The sides of my tongue went numb; My lips and cheeks started tingling; later my lips an... Read more
A bad cough; The sides of my tongue went numb; My lips and cheeks started tingling; later my lips and cheeks started tingling.; I developed drainage in the back of my throat; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 10:45 (at 34-year-old) (Batch/Lot number was not reported) as single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at workplace clinic. Medical history included fertility issues from an unknown date and unknown if ongoing. Concomitant medications reported as prenatal vitamin and folic acid supplement. Known allergies and allergies to medications, food, or other products was reported as no. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was waited for 15 minutes and then started drive to home. On 17Mar2021 at 11:15, the sides of tongue went numb, and then a few minutes later lips and cheeks started tingling. Also, developed drainage in the back of throat and a bad cough. The numbness in tongue only lasted a few minutes, but the other symptoms lasted several hours even after IV steroids and an epi shot. The events resulted in Emergency room/department or urgent care. The outcome of the event numbness in my tongue was recovered on 17Mar2021 whereas rest of the events was recovering. Information about batch/ lot number has been requested.
34 2021-07-02 ear pain, ringing in ears Tinnitus in both ears, although louder in the left ear. Occasional ear pain.
34 2021-07-02 mouth numbness Patient received her first vaccination at 9:48 this morning. Her 15 minute observation period was un... Read more
Patient received her first vaccination at 9:48 this morning. Her 15 minute observation period was uneventful. She stayed for an additional 15 minutes with her fellow Sister .She remained asymptomatic for a reaction and left at approximately 10:20. Patient and her Sister returned to our facility at approximately 10:27 with the following symptoms: lip numbness and right sided tongue numbness as described by the patient. She denied throat/lip swelling, shortness of breath, and respiratory compromise. Neuro check was negative. At 10:40 she stated that she felt light headed, described as "a funny feeling in her head." Her neuro check was negative. She was able to drink another 8 ounces of water and apple juice without difficulty.Her vital sign range remained unchanged: BP 105/palp, P62 and sat (6%. The decision was made with the patient, Charge Nurse and EMS to observe the patient for at least 30 minutes. During her observation period she was able to drink 24 ounces of water, 8 ounces of apple juice and consume 2 graham crackers. She showed no signs of compromise during that time. She continued to converse without difficulty. Her vital signs per EMT were as follows: 10:27 upon arrival: BP 138/palp P60, O2Sat 98% 11:00 BP 103/palp, P 63, O2 Sat 97% 11:15 at discharge: BP 118/ palp, P 68, O2 Sat 97% yAt the time of discharge her symptoms were resolved. Patient denied respiratory difficulty, none were noted, numbness of her lips and tongue and light headedness had resolved. Emergency precautions were discussed and patient agreed to call 911 or be taken to the nearest ER if her symptoms recur. Her Sister agreed. Patient was also advised to notify her PCP with her reaction to her first COVID Vaccination. She was discharged in stable condition with her Sister.
34 2021-07-04 ear pain Mild neck pain beginning several days after vaccine dose 1; limited to right side of neck, typically... Read more
Mild neck pain beginning several days after vaccine dose 1; limited to right side of neck, typically in evening only. After dose 2, it turned into excruciating pain in the right ear, right side of neck, right back of head, right side of face (past the sinuses), and significant swelling of the right thyroid, for approximately one month. then one more month of mild soreness in neck.
34 2021-07-06 eye swelling, visual impairment, sensitivity to light, bloodshot eyes Massive headache that started behind eye, made eye swollen and bloodshot, couldn't really see out th... Read more
Massive headache that started behind eye, made eye swollen and bloodshot, couldn't really see out the eye, sensitivity to light. Lasted for a whole day, headache lingered for three more days. Another headache like that (without the eye involvement) happened the next month and then the month after, but for shorter periods of time.
34 2021-07-07 lip blister A sore on my lip
34 2021-07-08 loss of taste Loss of taste Entire body hurt, even my bones felt like they hurt Mind fog/inability to concentrate ... Read more
Loss of taste Entire body hurt, even my bones felt like they hurt Mind fog/inability to concentrate Lethargy My period had started the day I took my second shot. It completely disappeared that night and hasn't returned as of writing. My flow is incredibly heavy the first two days, so I know I wasn't finished with my cycle.
34 2021-07-08 dry mouth felt a lump in the back throat; difficult to swallow; breathing difficulty; panic attack; mouth beca... Read more
felt a lump in the back throat; difficult to swallow; breathing difficulty; panic attack; mouth became increasingly dry; throat becoming more sore; hot flashes to my face; urgency to use the restroom; swollen throat; This is a spontaneous report received from a contactable consumer, the patient. A 34-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route in the right arm on 18Mar2021 at 07:15 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included Benign tumour removed schwanoma (3.5lbs). The patient had a history of allergy to penicillin, latex (nurse used latex free gloves) and normally that just cause a rash. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received macrogol 3350 (MIRALAX) for unknown indication within two weeks of vaccination. On 18Mar2021 at 07:15, the patient was very excited to get vaccine, within seconds of the shot she felt a lump in the back of her throat and difficult to swallow but was able to breathe and swallow. The patient also stated that throat was still very sore but she could breathe and swallow easily. The patient went back to paramedics in observation they told her she was having a panic attack which she never had before. The patient went back to her seat for a few minutes but her mouth became increasingly dry with difficulty to swallow and throat became sorer along with a few hot flashes to face, and felt an urgency to use the restroom. Nurse wheeled her out to bathroom and then took her to paramedics. They took her blood pressure and heart rate and told that she had a panic attack. The patient was not nervous about getting it so she did not know why that would be. Her throat stayed sore and swollen for about 48 hours. The patient had taken Miralax 3 days prior with no reactions. Doctor still wanted her to get second vaccine but she was scared of anaphylaxis. The patient did not receive treatment for the reported events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of felt a lump in the back throat, difficult to swallow, breathing difficulty, panic attack, mouth became increasingly dry, throat became more sore, hot flashes to my face, urgency to use the restroom and swollen throat were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
34 2021-07-10 taste impairment Metal taste within minutes of the vaccine; This is a spontaneous report from a contactable consumer,... Read more
Metal taste within minutes of the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old not pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: Unknown), via an unspecified route of administration in left arm on 26Mar2021 at 14:30 (at age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic sinusitis. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination. The patient had not been tested for Covid-19 since the vaccination. On 26Mar2021 at 14:30, the patient had metal taste within minutes of the vaccine. The patient did not receive any therapeutic measure for the reported event. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event metal taste within minutes of the vaccine was resolving at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
34 2021-07-12 ear congestion, swelling around the eyes Mild allergic reaction in first 30 mintues; swollen glands; ears clogging; puffy eyes; sore throat; ... Read more
Mild allergic reaction in first 30 mintues; swollen glands; ears clogging; puffy eyes; sore throat; itchy skin random spot and at injection spot; turned red all over; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, Solution for Injection, Batch/Lot number: EN6284), via an intramuscular route in arm left on 17Mar2021 at 17:30 (at the age of 34-year-old), as a single dose for covid-19 immunization at Health Department. The patient medical history included appendix removed, surgery in 2004, gall bladder removed, surgery in 2003, colon polyps, surgery colonoscopy in 2015 and acid reflux, slow emptying emptying test (2000) at the age of 12 (ongoing). Allergies to medications, food, or other products: Shellfish, leviquinn, augmentine, environmental, drug and food allergies for which patient has taken allergies shots 1997 to 2000 and prescribe treatment of meds, allergies that induce asthma, no glad bladder and appendix acid reflux Ibs, reaction to vaccine and allergy. Concomitant medications included Ibuprofen for tooth pain, fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR), Inhaler for reaction to vaccine and allergies, everyday (No inhaler unless needed), orally and all were ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 17Mar2021, the patient experienced mild allergic reaction (reaction to shot) in first 30 minutes (reported as onset time: 20mins, 24 hours after), swollen glands, ears clogging, puffy eyes, turned red all over, sore throat, itchy skin random spots and at injection spot. She had allergic responses to both shots given. Therapeutic measures taken as a result of the events included doctor onsite advised dosing with 3 bendryls, through mouth 1 dose before and 2 after given shot stayed 30mins and monitored her. The most side effect became less after 1 hour and dosing with 3 bendryls 1 dose before and 2 after given shot. Patient had all side effects reported and were severe. Lasting 4 days after 1 shot. The outcome of the events was recovered on an unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.
34 2021-07-12 sudden hearing loss, deafness unilateral sudden loss of hearing in left ear (same side of injection site)
34 2021-07-12 swollen tongue, lip blister Approximately two hours after the shot, a cold sore/blister popped up on my bottom lip. Within minut... Read more
Approximately two hours after the shot, a cold sore/blister popped up on my bottom lip. Within minutes, I felt my tongue begin to swell and then my airway began to swell/constrict and it was difficult to breathe. This caused my heart rate to increase and I was forced to lie down. I took an antihistamine and monitored my oxygen and had to remain lying down for about two hours. I then began to feel better. I did not have to use an Epi pen. I still felt dizzy with an increased heart rate and some difficulty breathing from time to time that evening, but it was better than the initial reaction. After that I had two incidents within the month after the shot of feeling like it was difficult to breathe again. Since April, I have not had any more incidents of difficulty breathing/constricted airway/heart racing. I was advised not to get the second dose due to my reaction. I informed my doctor of the reaction and then went for a doctor's visit a couple of months later to get a full check up due to the two other incidents of difficulty breathing after the vaccine and to make sure everything seemed okay.
34 2021-07-12 taste disorder Five days after receiving the vaccine I experienced fluttering in my chest and shortness of breath. ... Read more
Five days after receiving the vaccine I experienced fluttering in my chest and shortness of breath. I experienced these symptoms for approximately one month. I did not have a cough or any mucus. It seemed difficult to identify why I was feeling this way. I went running approximately a week after my symptoms began and tasted blood while I was running. I run semi frequently and have never experienced that symptom with exercise.
34 2021-07-13 pain in jaw, blindness in both eyes, eye discomfort, visual impairment, eye pain, sensitivity to light February 23 woke up in the middle of the night with sudden left peripheral vision loss. Developed se... Read more
February 23 woke up in the middle of the night with sudden left peripheral vision loss. Developed severe eye pain and light sensitivity, pain with eye movement one week later. Saw ophthalmology, referred to neuroopthamology. Has increased eye pressure in left eye and brimodine drops started. Having scotoma-like vision changes in left eye along with intermittent eye pain and jaw pain. Pain and vision changed lasted 3.5 months before resolving. Eye pressure elevation resolved. Also saw retina specialist and PCP. Had MRI, CTA, US all performed to find underlying cause. No cause was found. Assumption is inflammatory response of some sort, cannot explain Visio loss, vision change, eye a s jaw pin, and increased eye pressure.
34 2021-07-13 swollen tongue, vision blurred, tongue disorder, mouth discomfort Two weeks after the second shot I developed burning in my mouth (lasted 3 days), bumps on tongue, sw... Read more
Two weeks after the second shot I developed burning in my mouth (lasted 3 days), bumps on tongue, swollen tongue still 3 months later. Extremely swollen lymph nodes in neck and very painful. This lasted 5 days. Three weeks after the second shot I lost feeling/use of right arm, left side of face went numb, garbled speech, cognitive issues. Went to the hospital. MRI, ECG unremarkable. Lab work showed high Eosinophils (7x higher than my normal count). Was sent home same day. Next morning I woke up and my eyesight in left eye was blurry. Optometrist diagnosed 20/40 vision when it was previously 10/20. ANA labs run and came back high at 1:320. I regained function in my arm after a day but have memory issues and severe brain fog some days. For a month following my ER visit I had severe heart palpitations that would wake me up while sleeping. Occasional tingling in extremities. My medications I've been on for 10 years prior to the vaccine I cannot take anymore. They trigger symptoms. I have exercise intolerance and medication intolerance.
34 2021-07-14 loss of taste Loss of taste
34 2021-07-15 mouth numbness At 11:30am patient complained of "feeling dizzy" and a "numb tongue". We advised staying another 15 ... Read more
At 11:30am patient complained of "feeling dizzy" and a "numb tongue". We advised staying another 15 minutes after the initial 15 minutes. Patient agreed. Pt was able to stand without issue after 30 minutes. Denied numbness before she left. She didn't drive here, but walked from home. She refused to go to hospital and said she was fine to walk home.
34 2021-07-16 visual impairment the evening after receiving the shot, i started to feel tired and have a headache. theat night, it p... Read more
the evening after receiving the shot, i started to feel tired and have a headache. theat night, it progressed to a debilitating migraine, severe joint pain, and sharp, shooting pain along my spinal cord at the nerve roots. i was unable to sleep or rest because of the pain for 2.5 days. the migraine with nausea and visual disturbance lasted for 6-7 days. on 7/7, i got light headed and felt faint - i held on to the wall for support and my head went dark - this had been happening to me a lot over the past few weeks, but i thought was potentially related to the heat wave the week prior - but this time i experienced what felt like a mild seizure at the same time, something i'd never experienced before and felt reminiscent of the nerve pain i experienced after the second dose of the vaccine
34 2021-07-17 eye swelling Eyes were swollen; This is a spontaneous report from a contactable consumer (patient) via Pfizer spo... Read more
Eyes were swollen; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored Program. A 34-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8735) via an unspecified route of administration in left arm on 26Apr2021 at 15:00 as dose 2 single (at the age of 34-year-old) for COVID-19 immunization. Medical history and concomitant medication was not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8732) via an unspecified route of administration in left arm on 29Mar2021 at 15:00 as dose 1 single (at the age of 34-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient stated that she took the second dose of Pfizer Covid-19 vaccine back in 28Apr (later clarified) and during the week after she took the second dose her eyes started to swell and she was experiencing it until now. Her eyes were swollen. Patient stated she had not taken anything for treatment, but she was trying to ice them. The outcome of the event was not recovered.
34 2021-07-17 mouth numbness, mouth tingling Mouth and tongue started tingling; Mouth and tongue started tingling; Mouth and tongue numbness; Thr... Read more
Mouth and tongue started tingling; Mouth and tongue started tingling; Mouth and tongue numbness; Throat numbness; Mouth and tongue numbness; Throat also got very itchy; Slightly difficult to swallow; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in arm left on 29Mar2021 at 11:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy- allergic to medications with sulfur and fruit allergy (Mango was the only food she have ever had a reaction to). Concomitant medications included ZYRTEC, NASACORT, turmeric/curcumin, vitamin D3, vitamin B12, vitamin C and zinc. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with Covid-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. On 29Mar2021 at 11:30, within 30 minutes after the shot, the patients mouth and tongue started tingling and feeling numb at the same time. It felt like there was swelling but the patient did not see swelling when she had a look in the mirror at the back of her throat and she was unsure whether the numbness might made it feel swollen. The patient described that her mouth, tongue and throat felt like she had just received a numbing injection at the dentist or gargled with lidocaine. The patient also got very itchy throat and it was slightly difficult to swallow. The patient stated that she took 50 mg of Benadryl upon arriving home after the vaccination. The numbness and tingling lasted about 7 hours. The patient clarified that she did not see a doctor as her breathing was fine and the next morning, her throat was still itchy but numbness and tingling were gone. The patient had taken Benadryl as a therapeutic measure for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tingling mouth and tongue, numb mouth, numbness in tongue and numbness throat were recovered on 30Mar2021. The clinical outcome of itchy throat and swallowing difficult was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
34 2021-07-17 lip swelling This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history and allergic history to medications, food, or other products were reported as no. Concomitant medications included cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE) and ibuprofen (MANUFACTURER UNKNOWN); all for unknown indication from an unspecified date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 01770605) via an unspecified route of administration in the left arm on 06Mar2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 02:00, 36 hours after receiving second dose the patient experienced arm swollen at injection site and swelling was the size of an egg. On 29Mar2021 at 14:00, 48 hours after receiving second dose, patient lower lip swelled up and 6 hours later the top lip started swelling up. Lip swelling started going down 24 hours after the start of each area. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site swelling and lip swelling were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
34 2021-07-17 taste disorder, taste impairment Bitter taste in mouth immediately following vaccination.; Food/Drink does not taste as it normally d... Read more
Bitter taste in mouth immediately following vaccination.; Food/Drink does not taste as it normally does; Severe body aches; chills; fever; high heart rate; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old, non- pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 26Mar2021, at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included neuromyelitis Optica, postural orthostatic tachycardia syndrome (POTS), narcolepsy and adult onset stills disease. The patient had a history of allergy to bananas and tree nuts and amoxicillin. Concomitant medications included eculizumab (SOLIRIS), mycophenolate mofetil (CELLCEPT), prednisone (MANUFRACTURER UNKNOWN), and carbamazepine (MANUFRACTURER UNKNOWN) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 04Mar2021 at 16:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 21:00, after 5 hours of vaccination, the patient had experienced bitter taste, chills, fever, taste abnormal, high heart rate and severe body aches. it was reported as patient had bitter taste in mouth immediately following vaccination, food/drink did not taste as it normally, severe body aches, chills, fever and high heart rate. The patient did not receive any treatment for the reported events. Adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of bitter taste, chills, fever, taste abnormal, high heart rate and severe body aches was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
34 2021-07-17 ringing in ears, vision blurred, deafness, dry eye, eyelid function disorder it was cranial nerve 7 and 8 swelling; it was cranial nerve 7 and 8 swelling; Couldn't close left ey... Read more
it was cranial nerve 7 and 8 swelling; it was cranial nerve 7 and 8 swelling; Couldn't close left eye; Lost 40 percent of left ear hearing; 35 percent of left eye was blurry; Had dry eye; Bell's Palsy; Ringing in the left ear; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 intramuscular, administered in Deltoid Left on 18Jun2021 14:30 (at the age of 34 years old) (Batch/Lot Number: EW0181; Expiration Date: Aug2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in Deltoid Left on 28May2021 14:30 (Batch/Lot Number: EW0176; Expiration Date: Aug2021) as single dose for COVID-19 immunisation and did not have any problems with the first shot, received Flu vaccine for immunization and was fine. On 19Jun2021, the patient experienced bell's palsy, ringing in the left ear, couldn't close left eye, lost 40 percent of left ear hearing and 35 percent of left eye was blurry, had dry eye. On 25Jun2021, experienced cranial nerve 7 and 8 swelling. Caller stated his wife had not started with a primary physician. She just had a baby and had a gynecologist. They moved in the last 3 years. Caller mentioned that his wife had an ENT that she was seeing for the Bell's Palsy. Caller stated that his wife was taking medicine. It was 20 percent improved. It started ringing in the left ear. Caller's wife stated that it was cranial nerve 7 and 8 swelling. Caller stated that his wife was taking steroids and she was on 2 medications. Caller's wife provided medications as Valacyclovir for viral infection and the steroid Prednisone. Caller stated that his wife was healthy. She normally did not get to the doctor. She delivered a baby recently. Caller said that his wife's doctor recommended that she go to an eye doctor. She couldn't close her left eye. She was using surgical tape at nighttime because it would be very dry and eye gel and eye drops at night. She lost 40 percent of her left ear hearing. 35 percent of her left eye was blurry. She had dry eye. She could not close the eye. Caller stated that these symptoms started 19Jun2021. He initially stated he thought these symptoms as of yesterday was the same. However, later stated there is improvement there. There is improvement with the eye. He further explained she cannot tell with the left ear ringing. It is on and off. Yesterday his wife went to the doctor. The nerve was still the same, but the doctor said that it would take time to heal. The adverse events required a visit to physician office but not required to visit emergency room. No prior Vaccinations within 4 weeks. The patient underwent lab tests and procedures which included magnetic resonance imaging head abnormal: swelling nerve 7 and 8, no tumors on 25Jun2021. Therapeutic measures were taken as a result of ringing in the left ear, cranial nerve 7 and 8 swelling. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
34 2021-07-18 loss of taste, loss of smell Agency completed because of being Tested positive for COVID-19 infection 14 or more days after being... Read more
Agency completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/08/21pfizer,Lot# 2nd dose:01/29/21,Pfizer,Lot# Diagnosed covid positive:07/17/21 Exposure: Symptoms:cough, fatigue,muscle aches, loss of smell/taste,chills,runny nose,HA
34 2021-07-19 ringing in ears I had filed a previous report and have since had progressive symptoms, and also left out symptoms th... Read more
I had filed a previous report and have since had progressive symptoms, and also left out symptoms that at the time I didn't know were important to include. I spoke with a member of V-safe today, and she instructed me to send a new report. My current diagnosis of post-vaccine adverse reactions include vestibular neuritis, presumed small fiber neuropathy, and am undergoing cardiac evaluation currently for possible myocarditis versus POTS/dysautonomia. Below is more detailed information: I received the second dose of Pfizer on Friday January 8th. 13 hours after receiving the vaccine, I started with flu like symptoms (HA, neck pain, body aches, fever, restless, nausea, vomiting). 36 hours post-vaccine, I had profound fatigue, still felt feverish, scattered hives, headache and neck pain, and had intermittent dizziness. Day 3 and until this day I have had vertigo. That first week I had chest pain and dyspnea that would come and go, lasting until 2 (ish) weeks post-vaccine before seemingly resolving (more on this later). I was hospitalized Jan 15-16th, had extensive testing (CT, MRI, labs), and was diagnosed with vestibular neuritis from the vaccine. Headache and neck pain lasted through Jan 19th (ish). The weekend of Jan 23-24, I had paresthesias of my hands, feet, L forearm and L cheek that seemingly resolved. The vertigo was the main symptom (with the exception of hives that would occur nightly on my chest/back/neck for about 30 minutes (ish) and would self resolve) from Jan 25-April. The vertigo slowly improved over this time (missed many, many weeks off work for it). My husband and I would notice that I had issues with short term memory and word finding at times, with making easy decisions, and crowds would flare up all symptoms. PT reported that my therapy was unusual in that I had mild delayed cognitive slowing on their testing which is unusual for vertigo patients and more consistent in their concussion patients. I did additional vision therapy with OT as well. I don't know if this is important or not, but I started having hair loss in March and my menstrual cycles were irregular for Jan, Feb and March. In April things unexpectedly progressed. Early April I started with tinnitus which is still present to this day. April 29th I suddenly had a return of paresthesias, this time ascending, starting from hands/feet that progressed up my entire arms and legs bilaterally. I also developed weakness in my legs and arms where it was difficult to go upstairs and brush my hair. I saw my pcp, had a normal neuro exam, and was referred to neurology. I also had a return of chest pain this day and starting having issues with intermittent brain fog. I saw neurology on May 5th. The weakness was coming and going, not frequently, but the paresthesias persisted. I had a negative EMG on June 10th and was diagnosed with presumed small fiber neuropathy. No further work up or medications recommended by my neurologist. Since April 29th, I've had 3-4 discreet episodes of muscle weakness where walking any significant distance/up steps is difficult as noted above, lasting half a day-48 hours when it comes. The paresthesias have been persistent since April 29th. It's mainly in my hands/feet, forearms, and mid shin. Intensity waxes and wanes, sometimes I can't sleep due to the intense burning sensation. Sometimes I have issues where my hands feel clumsy such as with texting or some of the procedures I perform at work. July 2nd I again had another progression of symptoms while at work. I had worsening vertigo and paresthesia first, followed by intense chest pain with intermittent dyspnea, and later in the afternoon brain fog. I had been having intermittent chest pain since the end of April, but this was worse than I had ever had, and I also noted I was having intermittent palpitations/tachycardia. I ignored the issue until I went home and found my HR 100-120s for an hour while at rest. The tachycardia at rest did normalize after that hour. What I've had since then is intermittent tachycardia with standing/short walking and persistent frequent episodic chest pain both at rest and with exertion, long episodes (rare that i don't have pain), worse with exertion. Have been profoundly fatigued since this started. I woke up July 4th around 4am with intense chest pain and rapid HR and confusion, I think it lasted for a few minutes before I went back to sleep. July 4th daytime I had to stop in the middle of a flight of steps due to chest pain and dyspnea which is unusual for me. July 5-8 I was essentially confined to my couch due to feeling unwell/lightheaded/weak with any light activity (such as walking from the living room to the kitchen). Today my symptoms were slighty better, I was able to go to work for 3 hours administratively but again worsening symptoms with activity. I did see my pcp on July 8th, have a holter monitor from this visit with planned 14 day duration. On July 19th I had a stress echo which was remarkable only for trivial MR and smaller LV cavity size with exercise. Next step is for cardiac MRI to r/o myocarditis, but also POTS/dysautonomia is on the differential as well in terms of the cause of my CP and DOE.
34 2021-07-20 lip swelling Hives on hands and leg in morning that went away and again started at 5pm Swollen lips around 9.30pm... Read more
Hives on hands and leg in morning that went away and again started at 5pm Swollen lips around 9.30pm Took Benedrayl at 11.30pm
34 2021-07-22 eye pain Severe joint pain: began 04/18/21 6:32am & is ongoing. Pain was initially severe and impacted all jo... Read more
Severe joint pain: began 04/18/21 6:32am & is ongoing. Pain was initially severe and impacted all joints in body (hips, knees, ankles, shoulders, fingers, etc.) Worst pain presently is in hip joints, right shoulder, and left cheekbone (with visible swelling that lasted for approx 2 weeks). Pain is severe enough to interrupt ability to sleep and prevent normal function in daily life activities. Mobility negatively impacted. Sudden loud popping/cracking of hip and shoulder joints when attempting to move normally, followed by significant increase in pain. Ibuprofen 800mg makes zero impact. Acetaminophen 1000mg makes very minimal impact. Voltaren Arthritis Gel makes minimal impact. Norco 7.5mg makes moderate impact but pain still persists 24/7. Pins & needles itchiness (same as when having allergic reaction): began approx 5 minutes after vaccine administration & lasted for approx. 10 minutes before subsiding. Back & neck muscle pain: began 04/17/21 4pm & lasted approx. 8 days. Treated with Acetaminophen 1000mg and Aspercream. Chills, uncontrollable shaking, & feeling cold: began 04/18/21 5:44am & lasted until 04/19/21 Nausea: began very suddenly 04/18/21 5:47am & lasted until approx. 05/03/21. Treated with Dramamine 50-100mg ea. dose. Fever: began 04/18/21 approx. 7am & lasted until 04/21/21 with highest temp of 101F being on 04/18/21 8:53pm feeling like entire body was burning & face visibly red. Repeatedly treated with Acetaminophen 1000mg Throbbing headache encompassing head, forehead, and eyes: began 04/18/21 5:30pm & lasted for approx 8 days. Made worse by moving, standing up, or bending forward. Treated with Acetaminophen 1000mg Injection site tenderness and pain: began 04/18/21 3:57pm & lasted for approx. 3 weeks, slowly diminishing. Swollen lymph nodes on sides of neck (mostly left side): began 04/19/21 9:47pm & lasted for approx. 3 weeks Scalp & face (skin) painful sensitivity: began 04/19/21 & lasted for approx. 1.5 weeks. Skin on face, especially top half and on scalp very sensitive to even light touch to the point that touch felt painful. Allergic reaction symptoms: began 04/20/21 approx. 1am & lasted until 04/25/21. Initially felt tightening of throat with difficulty swallowing same as when having anaphylactic reaction (have had several); itching on arms began as well. Immediately treated with Hydroxyzine HCl 25mg & Benadryl 50mg. Throat tightness improved significantly at 3am. Itching on arms treated with Benadryl extra strength cream repeatedly until 04/25/21 when it resolved.
34 2021-07-22 burning mouth syndrome Woke up fatigued with heavy limbs; Woke up fatigued with heavy limbs; It progressed to dizziness; He... Read more
Woke up fatigued with heavy limbs; Woke up fatigued with heavy limbs; It progressed to dizziness; Heavy chest; Like a panic attack; Thighs became increasingly tired, sore, and weak; Muscles began twitching/Muscle twitching including arms, mid and upper back, abdominal muscles, groin muscles, and once the left side of the tongue; Overall body weakness noted, especially neck and arms; muscles are challenged they are susceptible to weakness, soreness, and muscle twitching, including arms, mid and upper back, abdominal muscles, groin muscles, and once the left side of the tongue.; muscles are challenged they are susceptible to weakness, soreness, and muscle twitching, including arms, mid and upper back, abdominal muscles, groin muscles, and once the left side of the tongue.; muscles are challenged they are susceptible to weakness, soreness, and muscle twitching, including arms, mid and upper back, abdominal muscles, groin muscles, and once the left side of the tongue.; muscles are challenged they are susceptible to weakness, soreness, and muscle twitching, including arms, mid and upper back, abdominal muscles, groin muscles, and once the left side of the tongue.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 18Mar2021 13:00 (Batch/Lot Number: EN6204) at the age of 34-year-old as single dose for covid-19 immunisation. Medical history included anxiety and mild depression. The patient had no known allergies. Concomitant medications included cyanocobalamin (VITAMIN B12) and vitamin d3, hypericum perforatum(ST. JOHN'S WORT); all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient woke up fatigued with heavy limbs. Patient went to work where it progressed to dizziness, heavy chest (like a panic attack), and thighs became increasingly tired, sore, and weak. Despite taking time off work to rest, thigh muscles remained sore, weak, and muscles began twitching. This progressed to calves in following days. Overall body weakness noted, especially neck and arms. When any muscles were challenged they were susceptible to weakness, soreness, and muscle twitching, including arms, mid and upper back, abdominal muscles, groin muscles, and once the left side of the tongue. Symptoms continued to present. Symptoms dissipate with continued rest and return from cumulative activity, sometimes over the course of a few days. Adverse event start date reported as 31Mar2021 08:30 AM. Events were serious as disabling/incapacitating. Events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No hospitalization prolonged. No treatment received for the events. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid test type post vaccination(Nasal Swab) on 08Apr2021 was negative.
34 2021-07-22 ringing in ears, ear congestion 4/08/21- extreme headache/pain/head pressure 4/12/21- ER visit- medications given: Benadryl, Torado... Read more
4/08/21- extreme headache/pain/head pressure 4/12/21- ER visit- medications given: Benadryl, Toradol, Ativan. 4/14/21- severe body tremors/ shaking/ uncontrollable body movements. 4/15/21- ER visit- medications given: Ofirmev, Gadavist, Zofran 4/20/21- headaches start to subside, neck pain and stiffness begins. Along with insomnia, panic attacks, heart palpitations, dizziness. 4/21/21: medications: medrol steroid pack, and z-pack. 4/25/21: tinnitus begins, extreme ear fullness, and sinus blockage. None of these symptoms have improved 5/05/21: visit to ENT. Prescribed prednisone. 10mg for 5 days. No improvement. 5/12/21: primary doctor prescribed Xanax for sleep. 7/05/21: All symptoms still persists. Added symptoms on this date are not body tingling, numbness in feet and legs, sharp body pains in knees elbows and toes..
34 2021-07-23 loss of smell, loss of taste Slight pain within 15 min of injection Slight rash on left arm after about 3 hours, lasted about 12 ... Read more
Slight pain within 15 min of injection Slight rash on left arm after about 3 hours, lasted about 12 hours Arm pain not as severe as first dose At around 9:00 pm within 5 min progressed from slight nausea to severe and vomitting Came in waves from 9:00 pm to 12:00 pm the following day. Severe vomiting- at least 16 times. Severe overall weakness, not able to move self well Would have gone to hospital but another family member had experienced similar side effects the month prior so assumed it would continue as long as his did. Very dehydrated By around 5:00 pm the following day started to be able to rehydrate without vomiting Started to feel back to normal around 4 days after injection After feeling back to normal the "longhaulers" symptoms I had been having since having Covid in 9/2020, including severe random joint pain mostly as night while laying down and loss of smell/taste have seemed to go away. Have not experienced since 7/3/2021
34 2021-07-23 ear pain A day later after the vaccine, pain started with the arm, neck and right shoulder. After three days ... Read more
A day later after the vaccine, pain started with the arm, neck and right shoulder. After three days after the vaccine severe pain in the ear, nostril, larynx and neck left side, including severe headache for the next 5 days. As the pain decreases, a notable type II degree II facial paralysis is generated on the left side. Two days after performing muscular facial and muscular exercises, a decrease begins to be noticed. To date the affected person also has pain in the neck, shoulder and arm
34 2021-07-25 taste impairment, ringing in ears Ringing in ears, extreme pain in injection site, migraine, chest pain, joint pain , fever, neck pain... Read more
Ringing in ears, extreme pain in injection site, migraine, chest pain, joint pain , fever, neck pain, metallic taste in mouth, itching, and body aches
34 2021-07-25 teeth hypersensitivity, toothache Around April 12, 2021, 1 or 2 teeth on the bottom right started to become sensitive to hot/cold and ... Read more
Around April 12, 2021, 1 or 2 teeth on the bottom right started to become sensitive to hot/cold and when I would chew. It felt like I had a cavity. I went to the dentist on April 22, 2021, and she confirmed I didn't have a cavity. She couldn't see anything wrong with the teeth in the area I was talking about. She tried to replicate the pain but had a hard time. She determined my enamel had come off and she tried to grind-down my tooth to fix. It was ok for a couple hours, but the pain did come back. I went back to the same dentist on May 25, 2021, and she still couldn't find anything wrong with my teeth. She asked if I had received the COVID-19 vaccine. I said yes and told her the dates. She said my teeth being sensitive and hurting when I chew is a result of the vaccine. She had spoken with other dentists who have seen this and there was nothing that could be done. The pain and sensitivity lasted until around June 14, 2021 and has been almost nonexistent since then.
34 2021-07-26 ringing in ears, visual impairment Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsi... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: tingling and numbness in extremities
34 2021-07-26 enlarged tonsils Swelling and pain of bilateral tonsils, lymph nodes in the neck, armpits, breast and groin that has... Read more
Swelling and pain of bilateral tonsils, lymph nodes in the neck, armpits, breast and groin that has lasted 5 days and is ongoing
34 2021-07-27 pain in jaw Jaw pain 6/29/21 then 7/6/21 Bells Palsy Left side.
34 2021-07-27 mouth tingling Slight confusion; Slight dizziness; Itching; Redness of skin; Some numbness of throat; Tingling lips... Read more
Slight confusion; Slight dizziness; Itching; Redness of skin; Some numbness of throat; Tingling lips; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the arm right on 05Apr2021 at 14:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown whether the patient had any known allergies to medications, food or other products. Concomitant medications included vitamin D nos (VITAMIN D) 50,000 IU, levothyroxine (MANUFACTURER UNKNOWN) 100 mg and vitamin E nos (VITAMIN E) all for an unknown indications, from an unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 14:30 the patient experienced slight confusion which abated within first 5 minutes after injection, slight dizziness, itching, redness of skin, some numbness of throat and tingling lips. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event slight confusion which abated within first 5 minutes after injection i.e. 05Apr2021 at 14:35, slight dizziness, itching, redness of skin, some numbness of throat and tingling lips was recovered on 05Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
34 2021-07-28 loss of smell, bleeding gums Breakthru Infection: Had bleeding gums 07/12/2021 Cold like symptoms up until 7/16 when I Fully real... Read more
Breakthru Infection: Had bleeding gums 07/12/2021 Cold like symptoms up until 7/16 when I Fully realized by loss of smell and such. Ongoing:Possible Delta but not confirmed
35 2021-01-01 loss of smell, loss of taste Moderate headache at night 12/30/20 Dry cough nonpersistent (AM), chills (PM) 12/31/20 Lost of taste... Read more
Moderate headache at night 12/30/20 Dry cough nonpersistent (AM), chills (PM) 12/31/20 Lost of taste/smell 01/02/21
35 2021-01-01 eye swelling Facial itiching with hypersensitive skin started a 2-3 days after injection. Swelling of face and ey... Read more
Facial itiching with hypersensitive skin started a 2-3 days after injection. Swelling of face and eyes and blotchy facial skin 13 days after injection. Seen by ED physician for steroids and benadryl. Slight decrease in swelling 24-36 hrs post start of steroid regimen.
35 2021-01-02 ear discomfort 12/23/20: within 2 minutes of receiving the vaccine I felt pulsing in my left wrist and weakness in ... Read more
12/23/20: within 2 minutes of receiving the vaccine I felt pulsing in my left wrist and weakness in my left hand, within 30 minutes my left ear felt like it needed to pop, I had the normal/expected side effects for the first 1-2 days (very sore arm, headache, achy, fatigue, mild joint pain) 12/24/20: weakness/numbness/cold feeling in my left lower leg and foot, fullness in left ear continued 12/27/20: same sx as 12/24, plus weakness/numbness in left forearm, pinky and ring finger 12/28/20: same sx as above, plus fullness in R earned weakness/numbness in right forearm, pinky, and ring finger 12/30/20: same sx as above, plus weakness/numbness on the left side of my face, no drooping 12/31/20: same sx as above, now with weakness/numbness/cold sensations on both sides of face (although only one side at a time), in both legs, both arms down into pinky and ring fingers (weakness noticed when typing and writing). Both ears still with fullness feeling (only one side at a time). I can still walk/run, these symptoms are still present as of today 1/3/21.
35 2021-01-02 eye pain Woke up Friday, 1/01, with sinus pain. Specifically burning pain in my sinuses and pain when I moved... Read more
Woke up Friday, 1/01, with sinus pain. Specifically burning pain in my sinuses and pain when I moved my eyes from right to left. Also had a generalized headache and body aches. On Saturday, 1/02, did have a fever of 100.2 but this has resolved. This morning, 1/03, the sinus pain has improved, still a slight headache and now major conplaint is lower back pain. Also have general malaise. No fever today either.
35 2021-01-03 eye bleeding burst blood vessel in left eye/blood in her eye; This is a spontaneous report from a contactable phy... Read more
burst blood vessel in left eye/blood in her eye; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899, expiry date 01Mar2021), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was hospital. Medical history included ongoing rheumatoid arthritis for about 8 years. No known allergies. Patient didn't do relevant test. Concomitant medication included duloxetine hydrochloride (CYMBALTA) for rheumatoid arthritis for 2 years, sulfasalazine for rheumatoid arthritis for 4 months, it's unknown if they were ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the vaccine yesterday (23Dec2020), which she was very excited about, but today (24Dec2020) she woke up with a burst blood vessel in her left eye, she appears to have blood in her eye. This has never happened to her before. She knows this can occur with patients that have COVID but didn't know if it was a side effect to receiving the vaccine. Patient didn't receive treatment for the adverse event. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was not recovered. The relatedness between COVID vaccine and event "burst blood vessel in left eye" was related by reporter. Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.; Sender's Comments: "Burst blood vessel in eye" is not uncommon in general population, and there are many causes of the event. Considering temporal relationship, a contribution role of the injection of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported Eye haemorrhage cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-01-03 lip swelling, mouth tingling At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my l... Read more
At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I ended up taking 25mg of Benadryl, then 50 mg of Benadryl 5 hrs later. The following morning my lips where feeling tingly again so I took 25mg of Benadryl again and continued for the next 48 hrs at the advice of my doctor.
35 2021-01-03 oropharyngeal discomfort ? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her th... Read more
? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her throat is warm and scratchy, and her left hand felt cold. ? I escorted her over to the ER and she was checked in. I then went right back to EOHD since we were so busy. ? Around 4pm in the afternoon after we closed EOHD, I went back to the ER. She was recovering and doing fine. Her ER nurse did have a question about receiving the 2nd dose, and I provided the same answer that Dr. provided to other Dr. about taking an Allegra 30 minutes before the second dose.
35 2021-01-03 mouth tingling, mouth numbness Left sided facial weakness, numbness and tingling in face, cheek, tongue, jaw, and neck. Diagnosed ... Read more
Left sided facial weakness, numbness and tingling in face, cheek, tongue, jaw, and neck. Diagnosed with Bells Palsy on 01/04/2021
35 2021-01-03 mouth tingling I am an APRN, and received the vaccine not quite one week ago. I waited 15 minutes within the facili... Read more
I am an APRN, and received the vaccine not quite one week ago. I waited 15 minutes within the facility and then left. Sat in my car working for about 8-10 minutes when a sudden rush of heat ran through my body. I felt lightheaded, my tongue was prickly, and I felt like I was going to pass out. I was able to get back into the facility to let them know of the sudden symptoms. At that time I felt like my heart was racing and was diaphoretic. They continued to watch me for another 15-20 minutes, they did have an epi pen but it was not given. I was feeling slightly better and then left again. I waited in my car approximately 20 minutes before deciding it would be safe to drive away. After driving for about 10 minutes I had another rush of heat, lightheadedness, and then I started having shortness of breath. At this time it would have been about 1 hour, maybe longer, since receiving the vaccine. I was not close to an emergency medical facility at that time, and did not feel like my throat was swelling so thought it would be best to try to drive to the nearest ER. I knew I had an epi pen from my work that I could use if needed. I contacted another nurse practitioner who I work with who stayed on the phone with me until I was able to get to a safe place. At that time the symptoms had improved, not resolved. It had been able 20 minutes during this episode. In all, I continued to feel jittery for about 3-4 more hours. Since my symptoms did improve I did not go to the ER. I contacted my health department, Louisville health dept, the following day and reported symptoms to the medical director.
35 2021-01-04 taste impairment Dizziness; Metallic taste upon injection; Sore arm; Headache; Muscle aches; Fatigue; This is a spont... Read more
Dizziness; Metallic taste upon injection; Sore arm; Headache; Muscle aches; Fatigue; This is a spontaneous report from a contactable healthcare professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on the left arm on 30Dec2020 14:00 at a single dose for COVID-19 immunisation. Medical history included hypertension (List of any other medications the patient received within 2 weeks of vaccination: Hypertension medication). On 30Dec2020 14:00, the patient experienced dizziness, metallic taste upon injection, sore arm, headache, muscle aches and fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was not recovered. Information on the lot/batch number has been requested.
35 2021-01-04 bleeding gums Bleeding bilaterally of both sides of lower gums between cheeks and inside part of lower lip; kind o... Read more
Bleeding bilaterally of both sides of lower gums between cheeks and inside part of lower lip; kind of pooling of blood in bottom of mouth; went through several tissues; Mild arm pain; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the left deltoid on 24Dec2020 at a single dose for COVID-19 immunization. Medical history included anxiety. Concomitant medication included sertraline for anxiety. The patient received the first dose of the COVID-19 vaccination at the time of report and wanted to report of a probable side effect that she had about an hour and a half after she got the vaccination. About an hour and a half after she received the vaccination, she started to experience bleeding from gum both sides, bilaterally of both sides of lower gums between cheeks and then also from the inside part of lower lip that lasted for about 3 to 4 minutes. It wasn't necessarily profuse bleeding but it was significant enough to cause pooling, kind of pooling of blood in the bottom of my mouth. And she went through several tissues and then it just spontaneously resolved on its own and haven't had any bleeding since. The patient had them 24 hours but didn't have any further bleeding episodes from anywhere. Since that time, the patient haven't noticed any other symptoms other than some mild arm pain. The bleeding has stopped, it stopped after about 3 to 4 minutes and arm pain kind of persisted but not worsened, not terribly bothersome. No treatment was given for the events. The patient wanted to understand if this is a side effect that's being reported by anybody and also whether a recommendation if she should still get this. Outcome of the event gum bleeding was recovered in Dec2020; event mild arm pain was not recovered. The reporter assessed the events as related to COVID-19 vaccination.
35 2021-01-04 mouth lesion 2 vesicles appeared on roof of mouth; Red bumps (rash) appeared in mouth; Left arm also very stiff/s... Read more
2 vesicles appeared on roof of mouth; Red bumps (rash) appeared in mouth; Left arm also very stiff/sore; Left arm also very stiff/sore; This is a spontaneous report from a contactable other healthcare professional (HCP). This 35-year-old female HCP reported for herself that she received BNT162B2 (lot number EH9899) 1st dose Intramuscular at left arm on 27Dec2020 at 12:00 PM for Covid-19 immunization. Medical history was not provided. Concomitant therapy included birth control. The patient experienced red bumps (rash) appeared in mouth, and 2 vesicles appeared on roof of mouth within 24-32 hours after receiving vaccine. Left arm also very stiff/sore for 24 hours after receiving vaccine. Event onset time was reported as 12:00 PM on 28Dec2020. No treatment was received for the events. The outcome of the event was resolving.
35 2021-01-04 swelling of eyelid Feeling of warmth, flushing, pruritic, eyelid swelling
35 2021-01-04 swollen tongue, tongue discomfort Patient reported burning at the injection site shortly after receiving vaccine. She had a burning /... Read more
Patient reported burning at the injection site shortly after receiving vaccine. She had a burning / swelling sensation of her tongue and otherwise felt unwell. She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy. She reports that her HR is usually 130 or less. She had a BP that ranged between 149-160/96-105. She reports this is elevated for her. Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.
35 2021-01-04 swollen tongue tongue swell; This is a spontaneous report from a contactable consumer (patient herself; a therapist... Read more
tongue swell; This is a spontaneous report from a contactable consumer (patient herself; a therapist, but was not clarified). A 35-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number: EK5730, expiration date: unknown), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization administered at the workplace. Relevant medical history included bipolar II disorder, hand tremors, and sleep (disorder). Concomitant medications included lithium and lamotrigine (LAMICTAL), both for bipolar II disorder; carbidopa, levodopa for hand tremors; and trazodone for her sleep. The patient had the vaccination and her tongue swelled on 26Dec2020, probably about 15 minutes after she had the shot. The patient had no investigation assessment. In response to the event, the patient had taken diphenhydramine (BENADRYL) at 25 mg, once; just one time. The outcome of the event was unknown.
35 2021-01-05 eye pain, eye swelling, swelling around the eyes I woke up with my eyes ever swollen and red (only my eyelids); I woke up with my eyes ever swollen a... Read more
I woke up with my eyes ever swollen and red (only my eyelids); I woke up with my eyes ever swollen and red (only my eyelids); they were still red and painful; My eyes were slightly puffy the next morning but nothing alarming; Night sweats that were worst the night of the vaccination; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 29Dec2020 17:00 at single dose in the left arm for COVID-19 immunization. Medical history included none. No known allergies. No other vaccine in four weeks. Concomitant medication included fluoxetine hydrochloride (PROZAC). Prior to vaccination, the patient was diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. The patient experienced night sweats that were worst the night of the vaccination. Her eyes were slightly puffy the next morning (30Dec2020) but nothing alarming, however, Thursday morning (31Dec2020 06:00) she woke up with her eyes ever swollen and red (only her eyelids). Thursday evening she'd been able to get the swelling down but they were still red and painful (after diphenhydramine hydrochloride (BENADRYL)). The events were non-serious. Employer and provider of vaccine had no protocol in place and said to treat it like any other reaction and go to ER if it worsened. The events were not resolved.
35 2021-01-05 swollen tongue chronic auto immune response; angioedema/tongue is swollen; urticaria/hives; This is a spontaneous r... Read more
chronic auto immune response; angioedema/tongue is swollen; urticaria/hives; This is a spontaneous report from a contactable other healthcare professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the right arm on 28Dec2020 10:15 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC), omeprazole (PROTONIX), naproxen sodium (ALEVE), and birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 16:00, the patient have a chronic auto immune response in the form of urticaria and angioedema. The symptoms of hives as well as swollen tongue was maintained with antihistamines. Outcome of the events was not recovered. The events were considered non-serious. The following information on the batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the events chronic autoimmune response in the form of urticaria and angioedema with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
35 2021-01-05 swollen tongue Developed mild tongue swelling and lips "felt funny". Took 1 Benadryl and symptoms improved slightly... Read more
Developed mild tongue swelling and lips "felt funny". Took 1 Benadryl and symptoms improved slightly. Extended her monitoring time in clinic until symptoms subsided. No further report of symptoms.
35 2021-01-06 taste impairment 35 y.o female present to the ER after receiving the first dose to her COVID 19 vaccine. Initially e... Read more
35 y.o female present to the ER after receiving the first dose to her COVID 19 vaccine. Initially experiencing a metallic taste in her mouth, palpitations, and nausea. She felt lightheaded but did not lose consciousness. Her symptoms rapidly improved. Her vital signs remained normal.
35 2021-01-06 ear discomfort, eyelid function disorder had a reaction of bells palsy with mild symptoms 5 minutes of receiving covid vaccine; facial numbne... Read more
had a reaction of bells palsy with mild symptoms 5 minutes of receiving covid vaccine; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; This is a spontaneous report from a contactable Other Health Professional reported that a 35-year-old female patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient experienced a reaction of bells palsy with mild symptoms 5 minutes of receiving Covid vaccine. "facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better, patient was vaccinated 10 days ago on 21Dec2020. Patient was treated with 60mg of Prednisone for 5 days which was started today." Question is regarding the 2nd dose of Covid vaccine, whether or not she should have it. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. .; Sender's Comments: There is a positive chronological association between vaccine administration and onset of the events. Causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
35 2021-01-06 mouth numbness, fluid in middle ear, eyelid function disorder, eye irritation, ear pain, dry eye it hits a nerve; perceived it along the face still and the arm; Bell's Palsy; numbness in a small ar... Read more
it hits a nerve; perceived it along the face still and the arm; Bell's Palsy; numbness in a small area of her tongue; right eye was irritated a little dry; right eye was irritated a little dry; right sided ear pain; fluid in the ear but no infection; This is a spontaneous report from a contactable health care professional (nurse practitioner). A 35-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on the right side on 21Dec2020 for Covid-19 immunization. Medical history included intermittent hives. Concomitant drug included ongoing cetirizine hydrochloride (ZYRTEC) 5 mg for intermittent hives. The reporting nurse practitioner saw a patient on 31Dec2020 who was vaccinated on 21Dec2020 and had a Bell's Palsy reaction (reported as not serious). She did some research and saw no more incidents in the general population but she wanted to report this. She also wanted to get more information on if the patient should proceed with dose number 2 of the vaccine. The patient developed the Bell's Palsy within 5 minutes after getting the vaccine. She thought it was because she was anxious to get the vaccine, so she brushed it off. The Bell's Palsy was still occurring but per the patient it had improved. On exam she did not have any weakness, facial droop or dumbness with sharp or dull testing. The patient perceived it along the face still and the arm. The reporting nurse practitioner said that the arm was probably not Bell's Palsy, but more related to getting the vaccine in the arm and it hits a nerve. Patient stated that her smile was also unequal and it was difficult for her to close her right eye, although now (as of 31Dec2020) she can. Her right eye was irritated a little dry. Regarding treatment, the patient was started on steroids on 31Dec2020. She did not start her on an anti-viral as she did not want it to impact her immunity to the vaccine. The patient also complained of right sided ear pain. She was unsure if that was related to the Bell's Palsy, but it was also on the right side. There was fluid in the ear but no infection. The pain was still ongoing. The patient also mentioned numbness in a small area of her tongue when she first got the vaccine. This was still ongoing. Outcome of Bell's Palsy was resolving. Outcome of the event numbness in a small area of her tongue, right sided ear pain was not resolved. Outcome of the other events was unknown. The reporting nurse practitioner stated that this was not serious as this was a mild case and was thankfully resolving. The reporting nurse practitioner comment that nothing of history was relevant besides for the last several months (as of 31Dec2020) the patient had been taking 5mg of cetirizine hydrochloride for intermittent hives. She wondered if she had not been taking it how she would have reacted or if the reaction would have been more severe. Information on the lot/Batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of Bell's Palsy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-01-06 feeling of choking Myalgia, Fever, Diarrhea, Tachycardia, chest tightness, SOB, 12/29 After vaccination felt chest tigh... Read more
Myalgia, Fever, Diarrhea, Tachycardia, chest tightness, SOB, 12/29 After vaccination felt chest tightness, shortness of breath, tingling in her throat, heart racing. She stayed and was monitored for an hour. When she got home she took Benadryl which helped her sleep. She continues to have mild shortness-of-breath today. Her left arm is sore and she has body aches. Her temp is 100.6 today. 12/30 1712: While speaking on the phone with her she is speaking in full sentences without apparent dyspnea. 12/31 had bad night - high fever 101.5 at 0100 overnight last night. This morning feels tired, lethargic, and no appetite. She still has body aches. No fever this morning. 1/4 - employee reports she is doing much better today. She says she had a rough weekend but is much better today. She able to get back to her running usually runs 25 miles/week.
35 2021-01-07 mouth numbness, mouth tingling, feeling of choking Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly... Read more
Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.
35 2021-01-07 pain in jaw, mouth tingling, mouth numbness Tachycardia 160?s, Sharp Left Jaw Pain, Left Facial Swelling, Tingling/Numbness Roof of Mouth and To... Read more
Tachycardia 160?s, Sharp Left Jaw Pain, Left Facial Swelling, Tingling/Numbness Roof of Mouth and Tongue
35 2021-01-07 mouth tingling, mouth numbness Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; Tin... Read more
Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; This is a spontaneous report from a contactable Other Health Professional (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Jan2021 02:30 at single dose for COVID-19 immunization. The patient had no relevant medical history and concurrent conditions. Known allergies: No (Allergies to medications, food, or other products: No). Other medical history: None. Concomitant medication received within 2 weeks of vaccination included biotin, meclizine (MECLOZINE), multivitamin. The patient experienced tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows on 05Jan2021 12:30 with outcome of recovered in Jan2021. The patient underwent lab tests and procedures which included COVID test post vaccination: Nasal Swab (Prc) on 27Dec2020 with result negative. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. Ibuprofen received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Information about Lot/Batch has been requested.
35 2021-01-07 mouth tingling, lip swelling tingly feeling to my lips; some lip swelling; tightness in my throat.; This is a spontaneous report ... Read more
tingly feeling to my lips; some lip swelling; tightness in my throat.; This is a spontaneous report from a contactable Other HCP. A 35-years-old female patient started to receive BNT162B2, via an unspecified route of administration from 30Dec2020 12:00 to 30Dec2020 12:00 at SINGLE DOSE for covid-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing, gastritis from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. Concomitant medication included lorazepam (ATIVAN), ivermectin (IVERMECTIN), escitalopram oxalate (LEXAPRO), esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), levocetirizine dihydrochloride (XYZAL). The patient previously took tamiflu and experienced drug hypersensitivity. The patient experienced tingly feeling to my lips (paraesthesia oral) (non-serious) on 30Dec2020 15:30 with outcome of recovered, some lip swelling (lip swelling) (non-serious) on 30Dec2020 15:30 with outcome of recovered, tightness in my throat. (throat tightness) (non-serious) on 30Dec2020 15:30 with outcome of recovered. The action taken in response to the event(s) for BNT162B2 was not applicable. Therapeutic measures were taken as a result of tingly feeling to my lips (paraesthesia oral), some lip swelling (lip swelling), tightness in my throat. (throat tightness). This is a spontaneous report from a contactable other HCP. This 35-year-old female other HCP reported that: Report about covid vaccine: Yes Reporter type: Patient Age group: Adult (18-64 Years) Is pregnant: No Race: (race provided) Ethnicity: (ethnicity provided) Patient occupation: Other Health Professional Covid vaccine details: product-COVID 19, Lot number-EL1284, Lot unknown-False, Administration date-30Dec2020, Administration time-12:00 PM, Vaccine location-Left arm, Dose number-1 Facility type vaccine: Hospital If other vaccine in four weeks: Yes Other vaccine 4weeks details: other vaccine 4weeks product -Allergy Immunotherapy injections , Other vaccine 4weeks vaccine date -07Dec2020, Other vaccine 4weeks dose number -2 , Other vaccine 4weeks vaccine location-Left and right arm. Other medications in two weeks: Nexium, xyzal, Ativan, Lexapro, Ivermectin Adverse event: At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I ended up taking 25mg of Benadryl, then 50 mg of Benadryl 5 hrs later. The following morning my lips where feeling tingly again so I took 25mg of Benadryl again and continued for the next 48 hrs at the advice of my doctor. Adverse event start date: 30Dec2020 Adverse event start time: 3:30PM AE resulted in: None of the above If patient recovered: Recovered If treatment AE: Yes AE treatment: Benadryl for 48 hrs If covid prior vaccination: No If covid tested post vaccination: No Known allergies: Tamiflu Other medical history: Chronic allergies, gastritis, anxiety, Depression Identification of the case safety report Serious: No Seriousness criteria-Results in death: No Seriousness criteria-Life threatening: No Seriousness criteria-Caused/prolonged hospitalization: No Seriousness criteria-Disabling/Incapacitating: No Seriousness criteria-Congenital anomaly/birth defect: No VAERS Primary Reporter Addl Qualification: Patient Relevant medical history and concurrent conditions: Structured information (Patient episode name): Chronic allergies, gastritis, anxiety, depression Reaction(s)/Event(s): Reaction/event as reported by primary source: At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I Reaction/event in terminology (LLT) : At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I ended up taking 25mg of Benadryl, then 50 mg of B Date of start of reaction/event: 30Dec2020 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED Drug(s) Information: Characterization of drug role: Suspect Batch/lot number: EL1284 Date of start of drug:30Dec2020 Anatomical location: Arm left Dose number:1 Active drug substance information: Active drug substances name: COVID 19 Drug(s) Information: Characterization of drug role: CONCOMITANT Proprietary medicinal product name: Allergy Immunotherapy injections Date of start of drug:07Dec2020 Dose number:2 Narrative case summary and further information: Case narrative Age at vaccination: 35 Pregnant at the time of vaccination?: No Start Date/Time:30Dec2020 12:00 PM Facility where the most recent COVID-19 vaccine was administered: Hospital Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Yes List of any other medications the patient received within 2 weeks of vaccination: Nexium, xyzal, Ativan, Lexapro, Ivermectin Reported Event: At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I ended up taking 25mg of Benadryl, then 50 mg of Benadryl 5 hrs later. The following morning my lips where feeling tingly again so I took 25mg of Benadryl again and continued for the next 48 hrs at the advice of my doctor. Was treatment received for the adverse event?: Yes: Benadryl for 48 hrs Prior to vaccination, was the patient diagnosed with COVID-19?:No Since the vaccination, has the patient been tested for COVID-19?:No Allergies to medications, food, or other products: Tamiflu Vaccine Facility information available. Ethnicity information is available. Race information is available. Location of injection information is available for other vaccines within 4 weeks PRIOR.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
35 2021-01-08 loss of taste Headache, Myalgia, Fever, chills, loss of taste Narrative:
35 2021-01-08 bleeding gums Lower gums and lower lip bleeding gums about hour 1/2 after the inj. It lasted about 3-4mins. Pain... Read more
Lower gums and lower lip bleeding gums about hour 1/2 after the inj. It lasted about 3-4mins. Pain at the inj site.
35 2021-01-08 feeling of choking ? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her th... Read more
? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her throat is warm and scratchy, and her left hand felt cold. ? I escorted her over to the ER and she was checked in. I then went right back to HD since we were so busy. ? Around 4pm in the afternoon after we closed HD, I went back to the ER. She was recovering and doing fine. Her ER nurse and patient did have a question about receiving the 2nd dose, and I provided the same answer that Dr provided to Dr about taking an Allegra 30 minutes before the second dose. ED Note: Patient presents with symptoms concerning for angioedema or anaphylaxis after immunization with Covid vaccine. Patient described a sensation of warmth and also later tingling in her throat which was treated aggressively with medication for this problem so as to prevent airway closure or further worsening symptoms. Patient was treated with IV fluid hydration along with H1 and H2 blockers, IV steroids and also subcutaneous epinephrine. On my reevaluation, her symptoms completely resolved with treatment. She was without other concerning findings on examination or by history and was without further angioedema or anaphylaxis after period of observation. She was discharged with prescription medication in good condition and asked to return should she have any further problems. Immpression: Angioedema, allergic reaction to vaccine, throat tingling, throat warmth MEDS in ED: Sodium Chloride 0.9% (Sodium Chloride 0.9% Bolus) 1,000 mL once IV Bolus, Reason for Infusion = Abnormal fluid losses diphenhydrAMINE (Benadryl) 25 mg = 0.5 mL once IV push methylPREDNISolone (SOLUMedrol) 125 mg = 2 mL once IV push famotidine (Pepcid) 20 mg = 2 mL once IV push EPINEPHrine 0.3 mg = 0.3 mL once intraMUSCULAR
35 2021-01-08 swollen tongue 15 hours after immunization patient reported swelling of tongue. Gums and tongue felt raw. Swelling ... Read more
15 hours after immunization patient reported swelling of tongue. Gums and tongue felt raw. Swelling resolved ~36 hours after onset
35 2021-01-09 lip swelling, swollen tongue Swelling, redness, moderate itching at injection site Mild numbness, burning, raw feeling with mild ... Read more
Swelling, redness, moderate itching at injection site Mild numbness, burning, raw feeling with mild feeling of swelling of tongue and lips, coughing, tightness in chest, flushed cheeks, Red rash under left arm pit, temp of 100.4. Body aches.
35 2021-01-10 light flashes or floaters in the eye, vision blurred 30 minutes of blurred vision with flashes of light.
35 2021-01-11 mouth numbness aproximately 5 min after receiving the vaccine, client started c/o light headeness,dizziness, hot fl... Read more
aproximately 5 min after receiving the vaccine, client started c/o light headeness,dizziness, hot flashes,and a numb lip, cold and shivering. they started o2 at 4liters via nasal canula and gave her 2 Benadryl 25mg oral tabs. At 10:40 she said she felt better, not dizzy, lip not numb, and wasn't feeling cold. She said she would contact her pcp and let him know. She felt good enough to drive off.
35 2021-01-11 mouth lesion I started developing a rash in my mouth, and flu like symptoms. My lymph node were swollen.
35 2021-01-11 mouth tingling, mouth numbness Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of to... Read more
Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of tongue; numbness and paresthesia of tongue; pain in left upper arm between elbow and shoulder; tachycardia; elevated blood pressure; This is a spontaneous report from a contactable physician. A 35-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular at arm left on 31Dec2020 at single dose for covid-19 immunization. The vaccine was administered at other (as reported). Medical history included asthma (Allergy induced asthma). Concomitant medication within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) from Dec2020 at 10mg daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020, the patient experienced Left Bell's palsy, numbness and paresthesia of tongue, left side of face, inability to raise left eyebrow, pain in left upper arm between elbow and shoulder, tachycardia, elevated blood pressure. The adverse events result in emergency room/department or urgent care. The patient received treatment for the adverse events which included Prednisone 20mg daily, Valacyclovir 1000mg twice a day. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Bell's palsy and other reported events due to temporal relationship. However, the Bell's palsy may possibly represent a concurrent medical condition. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including viral serologies, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-01-11 mouth tingling 30 minutes after administration, my tongue and mouth became tingly and "fuzzy" causing me to have to... Read more
30 minutes after administration, my tongue and mouth became tingly and "fuzzy" causing me to have to continually clear my throat. My neck then began to itch and I broke out into a rash around the front of my neck.
35 2021-01-11 mouth tingling right arm numbness/tingling chest tightness dry heaving passed out lips and tongue tingling th... Read more
right arm numbness/tingling chest tightness dry heaving passed out lips and tongue tingling then swelled. 50mg IM Benadryl administered, vitals monitored, RR called and I was transported to the ER and given more medications.
35 2021-01-11 thirst After vaccination I felt diaphoretic and dizzy. After waiting in the monitoring area for 45 minutes ... Read more
After vaccination I felt diaphoretic and dizzy. After waiting in the monitoring area for 45 minutes I drank some water and felt like my bilateral upper thighs were difficult to lift when I tried to walk to my car. I went home and was tachycardic 120-130bpm that continued throughout the night to the point I couldn't sleep my heart was pounding so hard and fast. I was extremely thirsty and dehydrated all night. I continued to have tachycardia for several days despite hydrating. My thighs also continued to feel week for several weeks. I developed a 100.7 F temperature and had flu like symptoms the following days.
35 2021-01-11 vision blurred 12/21 symptoms were achy light headed, swollen arm, blurred vision, vomiting, fever. Vaccine given ... Read more
12/21 symptoms were achy light headed, swollen arm, blurred vision, vomiting, fever. Vaccine given 12/18. She was tested for covid 19 on 12/28 and was positive.
35 2021-01-12 mouth tingling, mouth swelling About 10 minutes after the vaccine was given, patient experienced flushing, tachycardia. No SOB nor ... Read more
About 10 minutes after the vaccine was given, patient experienced flushing, tachycardia. No SOB nor difficulty breathing. Tingling to mouth and slight swelling. Rapid response called. Monitored for 2 hours. Post dose redness resolved. Tingling sensation remained.
35 2021-01-12 mouth tingling About 10min after vaccine given, patient c/o dizziness, tingling to lips, no SOB nor difficulty brea... Read more
About 10min after vaccine given, patient c/o dizziness, tingling to lips, no SOB nor difficulty breathing. VS stable. A rapid response was called but patient monitored. Dizziness resolved.
35 2021-01-13 visual impairment About 11:30 while at working all of the sudden my peripheral vision became black, my bp raised to ... Read more
About 11:30 while at working all of the sudden my peripheral vision became black, my bp raised to 180/120 and I was sent to the ER (Hospital) for monitoring. After some time it leveled out and I was released home to rest. That night and the next day I had a migrane, felt sluggish and really couldnt do anything. I took tylenol and motrin to help with the pain.
35 2021-01-14 loss of smell, loss of taste Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous re... Read more
Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse (patient). A 35-year-old female patient (weight 55.79 kg, height 160 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK5730) intramuscularly, in the left deltoid, at single dose, on 23Dec2020 at 12:30, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were none. On 25Dec2020, the patient felt extremely tired (fatigue). On 28Dec2020, the patient had headache and minor cough noticed. On 29Dec2020, the patient experienced back pain and she said that it felt like sunburn soreness more than anything else. She said that she literally slept 3 days in a row (29Dec2020, 30Dec2020, and 31Dec2020). On 31Dec2020, the patient lost her sense of smell and developed dizziness. On 01Jan2021, the patient experienced nausea and lost her sense of taste. COVID-19 virus test was found positive on 01Jan2021.The patient recovered from back pain, sunburn and sleepy on 31Dec2020, recovered from tiredness on 01Jan2021, recovered from nausea and dizziness on 06Jan2021. Clinical outcome of the events, smell loss, cough, headache, and loss of taste was recovering. Final clinical outcome of positive COVID-19 test with symptoms was unknown at time of this report. The case was assessed as serious (medically significant). She is scheduled to get 2nd dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 13Jan2021 and is wanting to know if she is supposed to get it.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
35 2021-01-14 lip swelling Lips swelling, itching on neck, increased BP rapid response called received epi pen 0.3mg in vacci... Read more
Lips swelling, itching on neck, increased BP rapid response called received epi pen 0.3mg in vaccine clinic went to ED, received steroids, diphenhydramine, famotidine - monitored for 4 hours then released
35 2021-01-14 lip swelling lips swelling, itching on neck, skin blotchy, increased bp received epipen in covid vaccine clinic ... Read more
lips swelling, itching on neck, skin blotchy, increased bp received epipen in covid vaccine clinic went to ED, received steroids, diphenhydramine, and famotidine, monitored for 4 hours then released
35 2021-01-14 mouth lesion chest tightness red rash around mouth body aches swollen lymph node on right side side of neck
35 2021-01-14 mouth tingling, mouth numbness From prescriber progress note: "The patient is a 35-year-old the presents emergency department with ... Read more
From prescriber progress note: "The patient is a 35-year-old the presents emergency department with sudden onset of scratchy pain in the throat that is worse with swallowing and numbness and tingling in the lips and tongue with difficulty breathing without cough that all started suddenly less than 20 minutes after receiving her 2nd COVID-19 vaccination. Patient states that since then pain is worse with swallowing and difficulty breathing is becoming worse. She denies any fever or chills. She states she does feel short of breath. She states she has not taken medication for this as of yet. Patient is hospital employee and was at hospital COVID clinic."
35 2021-01-15 mouth tingling, feeling of choking Itchiness in throat, feeling of a lump in my throat, tingling in throat and tongue. Very mild, no i... Read more
Itchiness in throat, feeling of a lump in my throat, tingling in throat and tongue. Very mild, no inability to breathe. Mild discomfort only. Benadryl seemed to keep reaction from getting worse. Sensation persisted for several hours and was gone the next day other than the slight feeling of a sore throat.
35 2021-01-16 deafness unilateral Sudden onset unilateral (left) sensorineural hearing loss and severe vertigo
35 2021-01-17 taste impairment, mouth numbness 1. WITHIN MINUTES OF THE VACCINE ADMINISTRATION IN MY LEFT ARM, I HAD LEFT SIDE NECK TENSION AND LEF... Read more
1. WITHIN MINUTES OF THE VACCINE ADMINISTRATION IN MY LEFT ARM, I HAD LEFT SIDE NECK TENSION AND LEFT SIDE UPPER BACK TENSION 2. AT 9:15PM (DAY OF VACCINE ADMINISTRATION), I DEVELOPED A METALLIC TASTE PAIRED WITH A NUMB FEELING IN MY MOUTH (TONGUE, HARD PALATE). 3. THE METALLIC TASTED LASTED ~30 HOURS POST VACCINE ADMINISTRATION 4. THE MUSCLE TENSION IN MY NEXT AND UPPER BACK SUBSIDED ~2 DAYS POST VACCINE ADMINISTRATION
35 2021-01-17 ear discomfort Extreme fatigue; Uncontrollable chills for 3 hours; Flu like symptoms; Generalized muscle soreness; ... Read more
Extreme fatigue; Uncontrollable chills for 3 hours; Flu like symptoms; Generalized muscle soreness; Stuffy nose and ears; Stuffy nose and ears; Short of breath; Loss of appetite; Headache; Headache; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 08Jan2021 07:15 at right arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 28Dec2020 at right arm, at single dose for covid-19 immunization, and experienced mild headache and mild arm soreness. The patient received the second dose, and experienced extreme fatigue, uncontrollable chills for 3 hours, flu-like symptoms (headache, generalized muscle soreness, stuffy nose and ears), short of breath, loss of appetite, all at 08Jan2021 13:00. The outcome of the events was recovering. No treatment was received for all events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
35 2021-01-17 gaze palsy Received 2nd dose of Covid vaccine on Wednesday January 13th at 1040am, soon after had headache but ... Read more
Received 2nd dose of Covid vaccine on Wednesday January 13th at 1040am, soon after had headache but was able to work. Thursday morning at 0330 severe body aches, chills, headache. Symptoms lessened with Tylenol but would come back through Friday the 15th. Had to call out of work Friday the 15th. Saturday the 16th Woke in a sweat and aches/chills have since stopped. Still experiencing headaches
35 2021-01-17 feeling of choking Patient's reaction(s) noted during COVID vaccine observation period: Pt states that 5 minutes after ... Read more
Patient's reaction(s) noted during COVID vaccine observation period: Pt states that 5 minutes after receiving covid vaccine she started to feel flush, sweaty, throat tingling. Vital signs taken: 1135: 134/80, HR 133, 97%O2 on RA. Pt sitting up in chair, drinking ice water, 1142: 133/61, HR 125, 97%O2 on RA, sitting in chair comfortable. Actions Taken: called ED clinician for evaluation per patient request. ED here at 11:56 to transport patient via wheelchair for evaluation. Pt in stable condition. Disposition: sent to ED for evaluation, received dose of diphenhydramine in ED with additional observation and then discharged.
35 2021-01-17 vision blurred At 11:07am second dose of Covid vaccine administered 11:30am post monitoring complete 12:30pm- manu... Read more
At 11:07am second dose of Covid vaccine administered 11:30am post monitoring complete 12:30pm- manual blood pressure recorded at 180/110 Woshing sound/ sensation in the right carotid Blurred vision in the right eye Heart beat irregular 1pm- Dr notified 1:30pm- Follow up phone call with Dr Manual BP 170/110 Prescription for Clonidine called to pharmacy 2pm- Clonidine 0.1mg taken 3:13pm- Manual BP 140/100 3:30pm-6pm- Napped 6pm- Manual BP 140/90 Clonidine 0.1mg taken
35 2021-01-18 eye pain started having a lot of left eye pain/he diagnosed her with Scleritis; This is a spontaneous report ... Read more
started having a lot of left eye pain/he diagnosed her with Scleritis; This is a spontaneous report from a contactable other healthcare professional (HCP) a Nurse Practitioner, who reported for herself. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EJ1685 also reported as ES1685), intramuscular in left deltoid on 24Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing anxiety diagnosed years ago, maybe when she was 23. Concomitant medication included ongoing celecoxib (CELEXA) for anxiety started about a year, or year and a half ago. She did not take other vaccines on the same day as the COVID vaccine. She had no recent labs. On 02Jan2021 the patient experienced scleritis. Event was described as follows: patient got her first COVID vaccine on 24Dec2020 and on 02Jan2021 she started having a lot of left eye pain. She went to her Ophthalmologist and he diagnosed her with Scleritis. She had no history of anything with her eyes or any vascular or autoimmune issues; no eye disorder history or rheumatology history. Patient is due to get her second dose of the vaccine on 14Jan2021, and she spoke with her primary care doctor and her ophthalmologist, and neither of them have any answer on if she should get the second dose or not, they did not have much guidance for her as this was such a new product. Patient reported that scleritis was persisting, but it has improved and she was on Prednisone eye drops. Event scleritis was considered serious as Medically significant because of what it is and what it can do, but this was not a severe case (as reported). Final outcome of scleritis was recovering.; Sender's Comments: The reported scleritis was more likely an intercurrent disease, and less likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
35 2021-01-18 ringing in ears Beginning today (1/19/2021) reports of abdominal pain, nausea, chills, tinnitus both ears. Tinnitus... Read more
Beginning today (1/19/2021) reports of abdominal pain, nausea, chills, tinnitus both ears. Tinnitus has resolved. Other symptoms remain. No home remedies taken.
35 2021-01-19 taste impairment Fever, then 1/19/21 at 10:00am metallic taste in mouth followed by severe fatigue and body aches and... Read more
Fever, then 1/19/21 at 10:00am metallic taste in mouth followed by severe fatigue and body aches and back spasms
35 2021-01-19 swollen tongue, mouth numbness, mouth tingling Described tongue tingling/numbness approximately 30 minutes after receiving the vaccine. Evaluated i... Read more
Described tongue tingling/numbness approximately 30 minutes after receiving the vaccine. Evaluated in ED - said it felt like tongue and throat were swelling. No immediate intervention required. Discharged with diphenhydramine oral PRN, famotidine 20mg BID, prednisone 60mg Daily x 3 days and EPiPen
35 2021-01-19 swollen tongue, mouth tingling, mouth swelling Patient described tongue tingling in approximately 30minutes after receiving the vaccine. She opted ... Read more
Patient described tongue tingling in approximately 30minutes after receiving the vaccine. She opted to be evaluated in the ED where she reported that her tongue/mouth felt swollen. SHe was assessed and no immediate intervention was necessary.
35 2021-01-19 tunnel vision, ear discomfort Felt okay upon awakening at 06:30am. Got a shower before work. Shortly after getting out of the show... Read more
Felt okay upon awakening at 06:30am. Got a shower before work. Shortly after getting out of the shower I became weak, ears started blocking, and started to have tunnel vision. Progressively got worse and was able to sit with head between legs. Took about 1 minute before I didn't feel like I was going to pass out. Shaky and weak after. Pulse 78 and oxygen level ok. Completed virtual visit and no further medical treatment advised unless symptoms got worse, but advised it was likely a vaccine reaction. Shortly after a bad headache and body aches developed (expected side effects).
35 2021-01-20 eye strain, tunnel vision, eye pain I started to feel rundown/fatigued in the evening on the day I got the vaccine and my arm was very s... Read more
I started to feel rundown/fatigued in the evening on the day I got the vaccine and my arm was very sore. I woke up very early the next morning with a fever of 101-102, body aches, severe headache, nausea, chills, severe fatigue, dizziness, difficulty concentrating, I would get tunnel vision, my eyes ached and felt very strained, sinus congestion and pressure. My fever spiked at 103.6 that evening and then stayed below 100 after that. For the following 7 days I still had the severe fatigue, nausea, headaches, chills, dizziness, difficult concentrating, tunnel vision that was especially bad when I had to drive, eye aches, sinus congestion and pressure, and my head felt very strange. The best way to describe it is that I felt like someone had drugged me. The only time I would leave my house was to take my daughter to school and when I would drive my head would feel super tight, my eye ache would intensify and they would feel super strained, I would get the tunnel vision and I would have trouble making it to the school and back home. Then I would go back to sleep for several hours, get up and drink some fluids and go back to bed. On day 7 or 8 I was able to stay up for periods of time and either watch movies or just lay in bed. I went back to work on 1/20 and am doing desk work. I am doing a lot better but still have daily headaches, moderate fatigue that is worse in the morning, mild intermittent nausea, my head still feels weird like I've been taking some kind of pain med or mild sedative, and I'm easily exhausted. I have trouble going grocery shopping because I get exhausted. I had a rapid COVID test done on 1/06/20 due to a headache and temp of 99.6-100.2, it was negative and we thought the temp was due to the Trokendi as that is a side effect of it. I also had a PCR done on 1/12 that came back negative.
35 2021-01-20 taste impairment FIEBRE VOMITOS SABOR METALICO EN LA BOCA ESCALOFRIOS DOLOR DE CABEZA DOLOR MUSCULAR
35 2021-01-20 oropharyngeal discomfort Minor Throat discomfort, feels like something in throat
35 2021-01-20 mouth tingling Tingling tongue, facial numbness on right side, lump in throat on right side
35 2021-01-20 taste disorder, visual impairment Nausea sore throat headache fatigue fever (100.5) body aches change in taste vision changes (cannot ... Read more
Nausea sore throat headache fatigue fever (100.5) body aches change in taste vision changes (cannot see items up close) injection site soreness with sharp pains that radiate down left arm
35 2021-01-20 visual impairment 10 min after vaccination patient complained of dizziness, feeling very warm. reminded her of the au... Read more
10 min after vaccination patient complained of dizziness, feeling very warm. reminded her of the aurora before migraine comes on. V.S. HR 75, Pulse ox, 99% BP 102/76, 0800 cool cloth applied to back of neck and and we put her head down. 0810 dizziness better seeing spots, 0810 Dizziness better spots persisted, 0825 same monitored and patient drinking water ate some crackers. 0830 V.S BP 114/80 HR 71 Pulse ox, 99% . 0835 bent over to pick up phone off the floor developed dizziness again cold, warm blanket applied monitored. 0850 feeling queezy and dizziness persistent 0900 sent to the ED per W/C. 2 sm. bottles of water taken in.
35 2021-01-21 ear pain Within an hour was feeling jumpy, easily startled, foggy thinking, fever (highest 101.6 normal temp ... Read more
Within an hour was feeling jumpy, easily startled, foggy thinking, fever (highest 101.6 normal temp is 97.5), unable to sleep for over 2 days (still haven?t slept partly due to extreme pain), extreme pain all over body especially on left side, racing heart (103 while laying down normal resting is 78), fever would not go down with any amount of fever reducer for 2 days (starting to slowly go down), sore throat, swelling in ankles and feet for two days (is going down now), congested nose, severe ear pain, joint stiffness and extreme ache. Itchy all over body and rash on back. I received the vaccine on 1/20 it is now 1/22 and most are still present though some are getting better very slowly. I did not seek medical care as no one would see me so I just have isolated myself and checked in with a good friend regularly. I just felt it important to report this as no one warns how bad the reaction may be and unlike with the first dose, absolutely no check ins from hospital. I find that to be completely unacceptable.
35 2021-01-21 drooping eyelid The patient was monitored for 15 minutes post vaccination with no issues. However on the drive home,... Read more
The patient was monitored for 15 minutes post vaccination with no issues. However on the drive home, she noticed some numbness of her right face as well as drooping on her eyelids. The patient came back to the hospital where she received her vaccine and checked into the ED. Physician's differential included Bell's Palsy vs CVA/TIA. The patient was discharged with prednisone 20mg daily for 7 days.
35 2021-01-21 oropharyngeal discomfort Patient became anxious, c/o throat irritation, throat and chest tightness. Patient monitored for lo... Read more
Patient became anxious, c/o throat irritation, throat and chest tightness. Patient monitored for longer period of time and permitted to go home once symptoms resolved.
35 2021-01-23 thirst patient walked into the post vaccination site. was sitting in chair states, "I am hot and thirsty" .... Read more
patient walked into the post vaccination site. was sitting in chair states, "I am hot and thirsty" . Patient then went limp in chair. when called by name she woke up then lost consciousness. Patient was placed in a W/C brought into med room to lay down. pt awake and breathing VS taken. drinking water. Vs continued to be monitored . Patient states, " I am really lightheaded and do not feel well'. Rapid response called, patient taken to ER. on a gurney with 2 nurses. Husband was notified, and updated.
35 2021-01-23 vision blurred I experienced a fever, headache, and body aches on the day after the vaccine and reported them. Now ... Read more
I experienced a fever, headache, and body aches on the day after the vaccine and reported them. Now today, four days after the vaccine I woke up with dizziness and blurred vision. I have not sought out treatment for this.
35 2021-01-24 inability to speak On the 26th, I had a sore throat that persisted, cough and loss of voice. I was out of work for abo... Read more
On the 26th, I had a sore throat that persisted, cough and loss of voice. I was out of work for about 5 days.
35 2021-01-24 dry mouth I have had ongoing fatigue, headaches, waves of nausea, dry mouth. It is still ongoing more than 2 w... Read more
I have had ongoing fatigue, headaches, waves of nausea, dry mouth. It is still ongoing more than 2 weeks out. I am unable to exercise. I sometimes have to get back in bed later in the day because of fatigue.
35 2021-01-24 ear congestion 1/14/21 Developed aching to my left underarm/armpit area while at rest. Aching has been ongoing and... Read more
1/14/21 Developed aching to my left underarm/armpit area while at rest. Aching has been ongoing and intermittent. 1/17/21 Developed left ear "fullness". On 1/20/21 went to GYN for exam, explained left underarm pain, told that my breast exam appeared normal, but she questioned if my left ear fullness and left under arm pain were related. 1/21/21 Left Ear "fullness" began to radiated causing left temporal pressure, spreading across forehead. Pressure developed behind both eyes. Sudden onset of dizziness occurred. Went to urgent care where they said I had swollen lymph nodes and believed I was having a auto immune response to something. Told I received the vaccine on 1/7/21, they said the symptoms could be related to the vaccine. 1/22/21 Notice I would occasionally feel like I had a "lump or pressure" to the side of my throat. As of present I am continuing to have Left Ear "fullness", left underarm aching, and bilateral eye pressure has bee intermittent yet ongoing.
35 2021-01-24 lip swelling, swollen tongue On Saturday, January 23, 2021 I woke up around 5:30 in the morning with itchy hands and feet, after ... Read more
On Saturday, January 23, 2021 I woke up around 5:30 in the morning with itchy hands and feet, after my second dose/ Just as I did with my first dose- Which subsided with Benadryl. However the second dose was given Thursday, January 21. The progressing of the itchy hands and feet lead to my bottom lip swelling excessively large , my tongue begin to swell, my upper lip begin to swell, my lungs begin to burn in my airway begin to tighten. I took two Benadryl and called my family to call 911 and take me to the emergency room. My blood pressure was very low pulse was very high. I had genital pain and swelling, dizziness , nausea vomiting, and extreme body pain. I was given epinephrine, breathing treatments, steroids, Benadryl, and IV fluids. Labs were drawn and my creatinine was high. After about four hours the swelling has gone down and I was able to go home. I have to take steroids for three days, Benadryl for seven , and famotidine. I have no history of severe allergies, in fact I was tested for food and environmental allergies about a year ago and everything came back negative. I have no history of reacting to any vaccine at any time.
35 2021-01-24 swollen tongue Swollen Tongue or Throat Nausea/Vomiting Headache Fatigue Dizziness Muscle aches Weakness Localized... Read more
Swollen Tongue or Throat Nausea/Vomiting Headache Fatigue Dizziness Muscle aches Weakness Localized pain and swelling at injection site
35 2021-01-24 ringing in ears Heart Palpitations; Sinus tachycardia; high blood pressure; fever; woke up in a pool of sweat; heada... Read more
Heart Palpitations; Sinus tachycardia; high blood pressure; fever; woke up in a pool of sweat; headache; ringing in her ears; Potassium was a little low, it was 3; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EK9231, expiration date Apr2021) intramuscularly on 12Jan2021 (between 8:30 to 9 am) at left deltoid for Covid-19 prevention. The first dose was received on Wednesday (unspecified date). Patient had no medical history and had no concomitant medications. At night of 12Jan2021, the patient had a fever of 102, but she went to bed with it and she woke up in the morning around 4:30 or 5 am (13Jan2021) in a pool of sweat, so she took her temperature and she was fever with 103.6. Patient took Motrin (Store Brand, lot number as either: 0GE2417A or OGE2417A, expiry: Apr2022) three 200 mg tablets, for a totally of 600 mg for the fever and had a cold shower, and the temperature came down to 103. Then after like 10-15 minutes of her laying on the couch with ice packs on her arms and stuff, it went down to 102.6. Patient was not going to go to the ER for just the fever, but then she started having heart palpitations, and she took her blood pressure and it was 170/113 and her heart rate was 176. Patient went to the hospital, and when they took her heart rate, it was 156. She had her blood taken at the hospital and everything was normal, except that her Potassium was a little low, it was 3. The ER did an EKG that showed Sinus Tachycardia and she was given IV Fluids (two boluses of 0.9% Normal Saline, 2000 mL total via IV, a bag of Potassium IV, two oral tablets of Potassium, unspecified total dose), and everything went back down. She had to call out from work that day and planed to follow up with her Primary Care Physician (PCP) in a couple of days. Patient was no longer had the fever, high blood pressure or high heart rate, as when she left the ER this morning, her temperature was 98, blood pressure was 111/82, and her heart rate was 96. She felt good now, but she did not know if it could happen again. Patient thought that it was maybe just her immune response to the vaccine, so she would say that she has recovered probably close to completely. Patient also had a headache and ringing in her ears, and those had resolved by now as well. The events Fever, Sinus tachycardia, Heart Palpitations, high blood pressure resolved on 13Jan2021 and other event resolved in Jan2021. The patient stated that the events (Fever, Sinus tachycardia, Heart Palpitations, high blood pressure) could have been serious with her blood pressure being so high, but it was not so serious because she did the right thing and went to the ER for treatment and got fluids. She believes the events (Fever, Sinus tachycardia, Heart Palpitations, high blood pressure) are medically significant. The patient believes that the events she experienced were directly caused by her receiving the vaccine, as she has never had these symptoms before other than she of course has had fevers in her life in the past.; Sender's Comments: A possible contribution role of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) to the onset of the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
35 2021-01-25 taste impairment metallic taste in mouth (went away with sleep and gone with wake up)/metallic taste in mouth came ba... Read more
metallic taste in mouth (went away with sleep and gone with wake up)/metallic taste in mouth came back; Muscle tension in left neck area and left upper back; This is a spontaneous report from a contactable other health professional (reporting for herself). A 35-year-old female patient received, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), LOT number: EL 3247 via an unspecified route of administration, on 13Jan2021 15:15 at a single dose, for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included sertraline. On 13Jan2021 15:20 The patient experienced muscle tension in left neck area and left upper back. On the 1st day after vaccination (14Jan2021 21:15), patient experienced metallic taste in mouth which went away with sleep and gone with wake up but on 2nd day after vaccination 15Jan2021 at 7:30, metallic taste in mouth came back. The outcome of events was not recovered. Patient did not received treatment due to the events. Events were considered non-serious. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
35 2021-01-25 mouth itchiness Minor itching of arms (not at injection site) and around lips.; Minor itching of arms (not at inject... Read more
Minor itching of arms (not at injection site) and around lips.; Minor itching of arms (not at injection site) and around lips.; This is a spontaneous report from a contactable consumer. A 35-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date not reported), via an unspecified route of administration at the right arm on 12Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included Latex allergy, chronic migraine, seasonal allergies, and had previous anaphylaxis due to insect stings. Concomitant medication included sumatriptan. The patient previously took Tylenol and experienced allergy. It was reported that the patient experienced minor itching of arms (not at injection site) and around lip. It was reported that the event started shortly after the thirty minute (15:15) wait after injection and ended around an hour after injection (15:45). Patient further reported that she has previous history of anaphylaxis due to insect stings. It was not bad enough to seek treatment and it took a bit to realize that it wasn't just a result of her worrying, but it was noticeable. No hives, no redness. Patient did not feel the need to seek treatment, but she did monitor symptoms until they eased. Vaccine was from a vial with no latex, due to existing minor allergy. No treatment was given to the patient in response to the event. There was no COVID prior to vaccination and no COVID test post vaccination. The patient recovered from the event on 12Jan2021 at 13:45.
35 2021-01-25 tongue discomfort lightheadedness; throat became scratchy; tongue felt thick; hives; itching; This is a spontaneous re... Read more
lightheadedness; throat became scratchy; tongue felt thick; hives; itching; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: E-1284), intramuscular in the right arm on 12Jan2021 at 14:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergy to IV contrast. The patient was not pregnant at the time of vaccination, had no other vaccine within four weeks, and did not have COVID prior to vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID; reported as other medication within 2 weeks). On 12Jan2021, less than 5 minutes after administration (also reported as at 02:15PM), the patient experienced lightheadedness, throat became scratchy, tongue felt thick, hives, and itching. These were resolved with Benadryl, Pepcid, Zyrtec, and IM steroids (also reported as PO and IM medications). It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. The patient has not tested positive for COVID post vaccination. Outcome of the events was recovered/resolved (also reported as recovering). Information on the lot/batch number has been requested.
35 2021-01-26 taste impairment Immediate onset of tachycardia and flushing, resolved after 5 minutes. 30-min delayed onset of metal... Read more
Immediate onset of tachycardia and flushing, resolved after 5 minutes. 30-min delayed onset of metallic taste in the mouth, resolved after 2 hours. 8-hours delayed onset of 8/10 arm pain and 8/10 fatigue, arm pain resolved after 4 days, fatigue improved after 3 days but has bet to resolve. 24-hours delayed onset of circular erythema around the injection site, approximately 6' in diameter, resolved after 9 days.
35 2021-01-27 mouth numbness Flushed; Hot feeling; Numb back of tongue or throat; Numb back of tongue or throat; This is a sponta... Read more
Flushed; Hot feeling; Numb back of tongue or throat; Numb back of tongue or throat; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL0142), intramuscular in left arm, on 08Jan2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history included Bell's palsy from 2017. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 18Dec2020 at 12 PM for COVID-19 immunization (intramuscular in right arm) and experienced flushed and hot feeling. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. The vaccine was administered in a hospital facility. On 08Jan2021 (12:30 PM), the patient experienced flushed or hot feeling 30 minutes after the second dose, followed by numb back of tongue or throat (best described like swallowing a good amount of throat numbing spray) that lasted about 2 hours. No treatment was administered for the events. The patient had not been tested for COVID-19 post-vaccination. The patient recovered from the events on 08Jan2021 (14:30).
35 2021-01-28 dry mouth 1420: patient approached vaccinator and c/o heart racing and temporal HA 1421 patient HR117 pO2 100%... Read more
1420: patient approached vaccinator and c/o heart racing and temporal HA 1421 patient HR117 pO2 100%. c/o pain moving to top of heat seated in chair 1442: HR114 BO 116/86 pO2 100% HA pain level 5-6 and described as "heavy" 1443 HR 99, drank sips of water and no new complaints 1445: HR 104, pO2 100% 1450 HR 95 head still the same no change or new symptoms 1451 HR 89-90 no change in symptoms 1455 c/o mouth dry but sips of water without c/o 1500 HR 92, pO2 99% no new symptoms head pain slightly improved 1515 States head pain is resolved States feels ready to leave clinic. 1530 left clinic without c/o. escorted ambulatory to meet friends for ride home.
35 2021-01-28 eye irritation, sensitivity to light 830am vaccinated, 12pm mild-mod headache and fatigue (sore arm at inj site), persisted, 10pm worse ... Read more
830am vaccinated, 12pm mild-mod headache and fatigue (sore arm at inj site), persisted, 10pm worse headache, fatigue, mild body aches started at shoulders and upper back and neck, able to fall asleep by 11pm, woke up at 1am in severe pain, migraine, head pressure, joint pain of every joint in my body, hands were swollen, felt like my joints were pulsating, very painful to bend or move any of my joints, muscle aches so bad any tiny movement hurt, even lying still hurt my back because of the pressure onto my back, even my spine felt tender, stiff neck I could barely look down or up but i could turn head left and right, stomach ache and nausea, my arm that was given vaccine was severely in pain and tender to touch and swollen at area of inj. There was light headed sensation w/ movement and position, pressure in my head felt like my head was going to explode and my eyes were burning. Because so severe, I took 1000mg tylenol, lathered by entire body in eucalyptus oil and peppermint on my hands, I was able to fall asleep at 3am but it was restless sleep I kept waking up because any movement I made in bed I'd have severe pain. 6am I felt moderately better all symptoms 50% improved, applied eucalyptus oil on again, started work at 730am I could barely function at work I have brain fog, just thinking focusing eyes concentrating makes migraine worse, +photopphobia, phonophobia, just typing is very hard to do because it hurts my joints, the vertigo worsened and the slightest looking down to the keyboard while typing causes lightheaded sensation. No improvement and it's now almost 1pm. I didn't take any pain medication or apply any essential oils.
35 2021-01-28 lip swelling, mouth numbness Patient felt chest tightness, dizziness, left cheek/lip swelling and numbness. Gave epi and transfe... Read more
Patient felt chest tightness, dizziness, left cheek/lip swelling and numbness. Gave epi and transferred patient to the ED.
35 2021-01-28 lip swelling, mouth tingling ? Day 10 after vaccine #1 upper lip swelling AKA angioedema ? Day 6 post vaccine #2 lower right lip ... Read more
? Day 10 after vaccine #1 upper lip swelling AKA angioedema ? Day 6 post vaccine #2 lower right lip and upper right lip swelling. Scratchy throat ? Day 10 post vaccine #2 wheezing like an asthma attack ? Day 12 post vaccine #2 Left, lower lip swelling, tingling in my tongue ? itchy for 2 weeks, 14 days post vaccine #2. Developed a sporadic, ever changing rash ? Day 16 post vaccine #2 a different, new rash
35 2021-01-28 vision blurred Nurse 1/28/2021 09:07:30 AM > 0855: Patient c/o blurred vision and dizziness, BP 170/80, P 108, O2 9... Read more
Nurse 1/28/2021 09:07:30 AM > 0855: Patient c/o blurred vision and dizziness, BP 170/80, P 108, O2 98. Upon assessment patient states she felt like "I'm going to have a seizure", patient completed 15 minute observation and nurse extended observation for additional 10 minutes. 0927: BP 120/78, P78, patient states "feeling much better" and has a doctors appointment tomorrow, nurse suggested that she should visit ER for further observation. Nurse 1/29/2021 08:19:42 AM > Contacted patient for f/u, message left Nurse /29/2021 08:45:01 AM > Spoke with patient, says that her heart rate seemed to be elevated most of the night and that she had to sleep sitting up, concerned about receiving s
35 2021-01-30 blindness Started with mild headache. Turned into severe migraine with stroke like symptoms (numbness in hand... Read more
Started with mild headache. Turned into severe migraine with stroke like symptoms (numbness in hands and face, loss of vision in one eye, seeing waves, dizziness, difficulty speaking). Vomiting, neck pain. PRN medications did not help. Went to ED at Hospital for 4 hours. MD ordered troponin level, metabolic panel, CBC, COVID test, and head CT. ECG. Given multiple rounds of toradol, Ativan, Benadryl, Reglan, fioricet. Sent home with fioricet. Continue to have daily headaches and neck pain.
35 2021-01-30 vision blurred hemiplegic migraine, blurry vision, slurred speech, high bp 140/103, l
35 2021-01-31 taste impairment Got vaccine on 01/15/21 and on 01/16/21 around 11:30 pm I started having rapid heart rate and short... Read more
Got vaccine on 01/15/21 and on 01/16/21 around 11:30 pm I started having rapid heart rate and shortness of breath. I also had a metal taste in my mouth. Before the rapid heart rate started, j bad chills, diarrhea and slight body aches. For about four to five hours my heart rate resting would be 60's and when a spell came on it would rise up to high 90's. It did this off and on every couple of minutes for about four to five hours. It was a very scary situation to be in: I can handle the chills, bod aches and diarrhea but when it comes to my heart rate bouncing around and taking my breath away, that was scary.
35 2021-01-31 oropharyngeal discomfort Received first dose of covid vaccine yesterday, 1/28. Dose given at 1:48pm. She was in the observati... Read more
Received first dose of covid vaccine yesterday, 1/28. Dose given at 1:48pm. She was in the observation room for 5 minutes when she developed itching on hands and then noticed hands were red, spread to arms, then chest and neck started itching. Took vitals, blood pressure was high, she attributes to anxiety, acknowledges that she was nervous about getting vaccine. Then within 10 minutes from vaccination started getting hives and throat started feeling swollen and difficult to swallow. They gave her epipen - after receiving epi she was able to swallow within 5 minutes, hives and rash were gone but still somewhat itchy. Was sent to ER - was given steroids - symptoms resolved. 35-year-old female presents to the ER for evaluation allergic reaction. Symptoms started approximately 30 minutes after receiving her 1st COVID vaccination. She states she became very flushed and itchy and began having some throat discomfort. She was given a IM injection of epinephrine and sent to the ER by EMS for further evaluation. She states she still having some itchiness to the arms and behind her ears. She states her throat still feels little scratchy but is not having go difficult time breathing. Denies associated chest tightness or shortness of breath. Denies any abdominal pain, nausea vomiting. Denies any prior allergic reactions to other vaccines are medications. 35-year-old female presents for an allergic reaction after receiving her 1st coronavirus vaccination. She was given IM epinephrine EN route. On my exam she appears in no acute distress. Blood pressures are stable. She is not tachycardic. She has normal O2 saturations. Her face does appear to be a bit flushed. She was given 125 mg of IV Solu-Medrol, 50 mg IV Benadryl and 20 mg IV Pepcid. She was observed for 2 hours and has significant improvement of her symptoms. Given a she was discharged home with instructions to use Benadryl as needed for any other allergic symptoms. She is instructed to return for increasing shortness of breath or throat tightness. She is agreeable this plan and discharged home.
35 2021-01-31 swollen tongue 12 hours later I had a full red body rash, red bumps, swollen hands, inflamed wrists, flu like sympt... Read more
12 hours later I had a full red body rash, red bumps, swollen hands, inflamed wrists, flu like symptoms, dizziness, nausea, headaches, swollen tounge, extreme exhaustion, a feeling of being completely out of it, otherworldly. I should have gone to the hospital but I have an extreme medical phobia so I stayed up and made sure my tounge didn't swell any further. The next morning my tounge was normal ish, the red rash was gone and my hands and wrists were back to normal. 5 days later and I am still experiencing headaches, my throat feels sore and a little bit of a hard time swallowing, extreme exhaustion, dizziness, nausea, a feeling of being completely out of it, otherworldly.
35 2021-02-01 lip swelling Lips double in size
35 2021-02-01 bloodshot eyes, double vision ached over body, equilibrium off, red eyes double vision, lasted 2 days pain injection site left ar... Read more
ached over body, equilibrium off, red eyes double vision, lasted 2 days pain injection site left arm last almost one week
35 2021-02-01 mouth tingling, burning mouth syndrome, lip swelling, swollen tongue, mouth numbness, swollen lips, feeling of choking Symptoms: tingly arm at injection site, numb and tingly and sore/swollen throat, tongue, lips. Dizzy... Read more
Symptoms: tingly arm at injection site, numb and tingly and sore/swollen throat, tongue, lips. Dizzy, high bp and tachycardia, heart palpitations. All within 15 minutes. Then at the ER deep cough, hoarse and difficulty speaking.
35 2021-02-01 mouth tingling Patient given first dose of Pfizer Covid vaccine. Upon administration felt burning at the injection ... Read more
Patient given first dose of Pfizer Covid vaccine. Upon administration felt burning at the injection site. patient then stated she felt tingling in her hands, feet, and mouth. Patient also stated that she felt her heart racing. BP 172/103, HR 149, SPO2 100% on room air. Denies SOB and difficulty breathing. Pt was transferred to ED. In ED was given oral prednisone and diphenhydramine. Assessment for possible drug reaction, not thought to be anaphylaxis, with mild anxiety contributing. Patient monitored and discharged in stable condition.
35 2021-02-02 dry eye, mouth numbness, pain in jaw Numbness to right side of tongue, spread to lips to entire right side of the face, pain in the right... Read more
Numbness to right side of tongue, spread to lips to entire right side of the face, pain in the right and right jaw, right eye itching and dry, Neuro exam, given high dose predizone,
35 2021-02-02 dry mouth Difficulty swallowing, dry mouth, sore throat
35 2021-02-02 eye irritation 2 hours after vaccine I developed headache, burning/hot feeling in eyes and fatigue. That night I ha... Read more
2 hours after vaccine I developed headache, burning/hot feeling in eyes and fatigue. That night I had chills, fever, full body joint pain, nausea, heavy head feeling, muscle pain and left arm pain at injection site. The next day I had severe painful swollen lymph nodes to left clavicle and under left arm. Second night I had ongoing fever, chills, muscle pain, fatigue and overall feeling under the weather. 7 days after I had right leg pain from thigh to ankle. Till today I still have generalized fatigue and swollen lymph nodes (although they are smaller that before)
35 2021-02-02 pain in jaw, ear pain Bell's palsy / pain in the left side of her face / pain irradiated to ear and jaw / tingling sensati... Read more
Bell's palsy / pain in the left side of her face / pain irradiated to ear and jaw / tingling sensation in left side of the forehead / facial weakness; This is a spontaneous report from a contactable Physician reported for self. This 35-Year-old-female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 15Jan2021 08:20 on Arm left at single dose for covid-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No known allergies. None concomitant medication included. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Dec2020 08:20 AM at the age of 35 year old via IM Injection Upper Left Arm for covid-19 immunisation, no reactions with first dose and flu vaccine, Expiry Date: Oct2020 for immunization and no reactions. The patient experienced Bell's palsy on 19Jan2021 and received prednisone 60 mg for 7 days. The same day of the vaccination (15Jan2021), she started to experience pain in the left side of her face, aggravated by 18Jan2021, her pain irradiated to ear and jaw. On Saturday 16 post vaccinated, she experienced also tingling sensation in left side of the forehead on 16Jan2021. She experienced facial weakness on 19Jan2021. And in 19Jan Monday evening Bells Palsy was confirmed. Lab data included Physical exams: weakness in the left side of forehead. No Covid tested post vaccination. Outcome of the event Bell's palsy was recovering. Outcome of other events was unknown. There was a reasonable possibility that the event Bell's palsy was related to BNT162B2. Information on Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
35 2021-02-02 tongue itchiness 01/29/2021 at 0902 given COVID vaccine. Approximately 0904 began symptoms of Itchy tongue and throat... Read more
01/29/2021 at 0902 given COVID vaccine. Approximately 0904 began symptoms of Itchy tongue and throat confusion, light headed, headache and throat swelling. Given the following: 0915 - 25mg Benadryl IM 0921- 0.3ml Epinephrine IM Went to Emergency room for monitoring and was released at 1230 same day.
35 2021-02-03 eye swelling Swelling under the eyes where prior hyaluronic acid acid filler was placed, which was in April 2019.... Read more
Swelling under the eyes where prior hyaluronic acid acid filler was placed, which was in April 2019. This occurred about 20-24 hours after the second dose of the Pfizer COVID vaccine and resolved approximately 20-24 hours later without any intervention.
35 2021-02-03 mouth tingling, dry throat, eye itchiness, lip swelling, mouth itchiness Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient reported that on 1/06/2021 they were admini... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient reported that on 1/06/2021 they were administered the vaccine and suddenly developed dry throat, itching at the roof of their mouth and a headache. Thought she needed a drink of water so she didn?t ask for help. She went home. Then her right eye began to itch. Then within the next 20 minutes she developed itchiness all over and her lips became tingly and slightly swollen. Vaccine recipient reported that they had a telehealth appointment occupational health and was prescribed prednisone. Then around 1115 am, she became dizzy and her heart rate increased to the 110s and developed chest tightness. By 1130 am she developed a scratchy throat and dry cough. They became dizzy after the phone call and told a family member to take them to the ED for worsening symptoms. While in the ED they received prednisone and Pepcid. During re-evaluation she improved and was discharge to home.
35 2021-02-03 mouth tingling, lacrimation increased, ear itchiness, swollen tongue 30 minutes after injection - muscle spasms in both arms from wrists to elbows 45 minutes after injec... Read more
30 minutes after injection - muscle spasms in both arms from wrists to elbows 45 minutes after injection - itching, warmth, rash, hives on face, neck, chest, arms, and legs 1 hour after injection - eyes watering and inner ears itching and stinging; itching all over body 4 to 5 hours after injection - tongue swelling and tingling
35 2021-02-03 sensitivity to light After receiving the shot at approximately 1600 (and waiting the 15 minutes at the clinic site), I re... Read more
After receiving the shot at approximately 1600 (and waiting the 15 minutes at the clinic site), I returned to my desk for work. Around 1740, I noticed a slight headache, which are abnormal for me, so I thought I might have been slightly dehydrated and increased my water intake, as well as ingested 8 ounces of gatorade. The headache gradually got worse and by the time I left work at 2000 (8PM), it was so bad on the (primarily) right front part of my head (around my temple and behind my right eye), noise, light, and even my own walking hurt terribly. I have never had a migraine in my life and rarely even get headaches, but the pain of this headache far surpassed any I have experienced before and based on what others tell me, might have been a migraine. By the time I got home around 2100 (9PM), I took two extra strength Tylenol tablets and went to bed. When I awoke in the morning around 0900 (9AM), I had a slight headache that dissipated after I took two more Tylenol tablets and did not return.
35 2021-02-03 swollen tongue Patient arrived at Center, where public health clinic hosts the COVID-19 Vaccination POD on 2/3/21 a... Read more
Patient arrived at Center, where public health clinic hosts the COVID-19 Vaccination POD on 2/3/21 at approximately 4:20pm. Patient received her 1st dose of COVID-19 vaccine-Pfizer Lot #EM9810. Patient reported having myasthenia gravis and having a history of allergies and carrying an EpiPen. Patient was advised by medic administering vaccine and RN administering questionnaire to wait for 30 mins in parking lot near medic vehicle and to honk her horn if she felt any sort of reaction. While waiting in her car, patient began to have trouble breathing and honked her horn. Medics identified her vehicle. Patient reported having trouble breathing, chest pain, tongue swelling, and a scratchy throat. Medics administered Epinephrine and Benadryl to patient and transported patient to Medical Center.
35 2021-02-03 vision blurred facial swelling; itching; blurred eye sight as times; This is a spontaneous report from a contactabl... Read more
facial swelling; itching; blurred eye sight as times; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (lot number: EL0140), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. Medical history included allergies to shellfish from an unknown date. The patient's concomitant medications were not reported. The patient previously took topamax and experienced allergies. On 01Jan2021, the patient experienced facial swelling, itching and blurred eyesight as times. The patient was not pregnant. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 01Jan2021. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of facial swelling, itching and blurred eyesight as times which includes steroids and antihistamines. The outcome of the events was recovering.
35 2021-02-04 swelling of eyelid Lower left eyelid swelling; This is a spontaneous report from a contactable nurse (patient). A 35-ye... Read more
Lower left eyelid swelling; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249), intramuscular in left arm on 20Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included calcium, ergocalciferol (VITAMIN D), ascorbic acid, colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMIN) in two weeks. Historical Vaccine included the patient received first dose of BNT162B2 (lot number: EK9231), intramuscular in left arm at the age of 35-year-old on 02Jan2021 10:00 at single dose for COVID-19 immunization. The patient experienced lower left eyelid swelling on 20Jan2021 19:00. No treatment received for the event. The patient was no pregnant. The patient did not receive other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the event was not recovered.
35 2021-02-06 mouth numbness Developed immediate dizziness and in the course of a few minutes developed numb sensation in lips an... Read more
Developed immediate dizziness and in the course of a few minutes developed numb sensation in lips and mouth, within 2-3 hours developed wheezing requiring albuterol at home medical treatment
35 2021-02-07 mouth numbness, mouth tingling tachycardia HR into 140s; numbness and tingling around lips; numbness and tingling around lips; warm... Read more
tachycardia HR into 140s; numbness and tingling around lips; numbness and tingling around lips; warm flushing; This is a spontaneous report from a contactable nurse (patient). This 35-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249) intramuscular, in left arm, on 22Jan2021 at 08:00, for COVID-19 immunization. No other vaccine was given on the same day or in 4 weeks. The patient received the first dose of BNT162B2 vaccine on 04Jan2021 at 03:00 PM, lot number EK9231, intramuscular, in left arm. Medical history included Crohn's disease. The patient had no COVID before vaccination. Concomitant medication included azathioprine (IMURAN) at 150 mg, daily. On 22Jan2021 the patient experienced warm flushing within 5 minutes of vaccination and at 08:15 tachycardia (HR into 140s), numbness and tingling around lips. The events required Emergency room/department or urgent care and treatment with diphenhydramine (BENADRYL) 25 mg IV. COVID was not tested after vaccination. The events were resolving.; Sender's Comments: Based on a compatible temporal association, causality between events tachycardia (HR into 140s), numbness and tingling around lips and warm flushing and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-02-07 swollen tongue Pt complained of a swollen tongue and feeling dizzy post vaccine. She hypotensive 70/40 mm/Hg, 44BPM... Read more
Pt complained of a swollen tongue and feeling dizzy post vaccine. She hypotensive 70/40 mm/Hg, 44BPM,rested and BP slightly improved to 86/57 mm/Hg, 56 BPM. At d/c BP was 104/70 mm/Hg & 75 BPM.
35 2021-02-07 visual impairment 1354-vaccine received; 1400-felt a squeezing in chest; blackness in the outside of vision; tingling ... Read more
1354-vaccine received; 1400-felt a squeezing in chest; blackness in the outside of vision; tingling hands; nausea1420-symptoms resolved
35 2021-02-08 lip swelling Approx. 5 hours after vaccine administered, bad headache and fatigue. Injection site and all upper a... Read more
Approx. 5 hours after vaccine administered, bad headache and fatigue. Injection site and all upper arm became very sore to the touch Approx. 6 hours after vaccine, face became very flushed, hot and inflamed. Lips began to slightly swell - both upper arms became red and hot, skin flushed - headache and fatigue persisted - fever of 99.9 Benadryl taken 8 hours after vaccine, which helped with hot feeling in face and hands, lip swelling went away
35 2021-02-08 mouth tingling 20 minutes after receiving the vaccine I started to feel swelling in my throat and a hot, tingling f... Read more
20 minutes after receiving the vaccine I started to feel swelling in my throat and a hot, tingling feeling on the inside surfaces of my mouth and tongue, my arm was also very itchy and had a lump approximately the size of half a golf ball at the injection site. I developed a severe headache as well. 23 minutes after the vaccine, I took 25 mg of Benedryl PO, 38 minutes after the vaccine, I took an additional 25 mg of Benedryl PO and 10 mg Zyrtec PO because my symptoms had not yet resolved. Approximately 1.5 hours after the vaccine administration my symptoms resolved, except for the headache and the lump on my arm.
35 2021-02-09 loss of taste fever/Had temperature of 101; Chills; Lost my sense of taste; Body ache; This is a spontaneous repor... Read more
fever/Had temperature of 101; Chills; Lost my sense of taste; Body ache; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302, Expiration Date: 31Mar2021) at 0.3 mL single use in right deltoid on 21Jan2021 for COVID-19 immunisation. The first dose was on 31Dec2020 and experienced night sweat, even after her first dose they had not gone away. She had had night sweat every single night to the point she had to get her clothes off and change (refer to AER 2021111645). Medical history included factor V leiden, it's a blood clotting "supporter" (not clarified); asthma. Concomitant medication was not reported. Patient had temperature of 101, chills, lost her sense of taste and body ache in Jan2021. Patient received her second vaccine on the 21Jan2021 on Thursday and she had all the typical side effects startling on Friday with fever, chills, had a temperature of 101 and all the simple stuff and she lost her sense of taste on Saturday evening and it hadn't returned yet and she was trying to see if that was a possible side effect of the vaccine or what. When probed if the events had been worsened, improved or persisting, patient stated so improved for everything except one. So she got the sot on Thursday and it worsened meaning the fever started Thursday night, Friday all day she had a fever of 101, body ache and chills all that stuff but Saturday her fever went away but she lost her sense of taste on Saturday, so the fever and everything was OK. Patient had taken naproxen and ibuprofen. The outcome of events was reported as recovered in Jan2021.
35 2021-02-09 loss of smell, loss of taste Loss of smell and taste; Loss of smell and taste; This is a spontaneous report from a contactable nu... Read more
Loss of smell and taste; Loss of smell and taste; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 08:30 at single dose, second dose of bnt162b2 via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included Sulfa allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included phentermine hydrochloride, topiramate (QSYMIA), rizatriptan benzoate (MAXALT). The patient experienced loss of smell and taste on an unspecified date. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown. Information on the lot/batch number has been requested.
35 2021-02-09 lip swelling Difficulty swallowing and lip swelling, given Benadryl, Zyrtec and Prednisone at 8:05. Swelling went... Read more
Difficulty swallowing and lip swelling, given Benadryl, Zyrtec and Prednisone at 8:05. Swelling went down by 10 am. Has some tingling in hands and feet through out that day, but stopped after 24 hrs. Had some pain in left armpit on Sunday and Monday. No more symptoms today.
35 2021-02-09 vision blurred Dizzy; Unbalanced when attempting to walk; Blurry vision; This is a spontaneous report from a contac... Read more
Dizzy; Unbalanced when attempting to walk; Blurry vision; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262; Expiration date was not reported) on 23Jan2021 (12:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the school or student health clinic. The patient had no relevant medical history. The patient had unspecified concomitant medications. The patient was not pregnant at the time of vaccination. On 24Jan2021 (21:00), the patient was dizzy; unbalanced when attempting to walk; and had blurry vision. It was unknown if the patient had received treatment for the reported events. The outcome of the events, 'dizzy', 'unbalanced when attempting to walk' and 'blurry vision', was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
35 2021-02-10 taste impairment, loss of smell Loss of sense of smell and metallic tasting food 1 week after receiving vaccine
35 2021-02-10 visual impairment Headache, disoriented, dizzy, trouble eating, tachycardia, labored breathing, trouble with vision
35 2021-02-11 lip swelling Presented with lower lip swelling and hives to inside of cheek within a few minutes of receiving the... Read more
Presented with lower lip swelling and hives to inside of cheek within a few minutes of receiving the vaccine. No tongue swelling. No SOB or throat itchiness. Offered Benadryl and transport to ED but she declined and went home.
35 2021-02-12 dry mouth, tongue discomfort Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1758. Patient reported itchy tongue and... Read more
Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1758. Patient reported itchy tongue and dry mouth, itching at injection site at 1809, she was given Benadryl 25mg po. At 18:20 itchiness and dry mouth resolved, but patient then developed chills and felt cold and clammy, visibly shivering. At 18:35 still had chills. 18:43 chills/shivering resolved but felt ?less cold?. 18:45 patient returned to the hospital to finish shift and give sign-out. Clinic RN gave another Benadryl 25mg to the patient and asked the patient to return to the vaccine clinic after the end of her shift to reassess. 19:36 Patient returned to clinic, all symptoms resolved.
35 2021-02-13 dry eye, mouth tingling Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1931. Then started experiencing lip tin... Read more
Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1931. Then started experiencing lip tingling at 1942. Benadryl 50mg given at 1944, tingling resolved at1950. Reports dry eyes but otherwise ok at 1956 and left the vaccine clinic.
35 2021-02-13 dry mouth, mouth tingling Starting about 8 minutes after injection a rush of light-headedness, right side of body felt heavy a... Read more
Starting about 8 minutes after injection a rush of light-headedness, right side of body felt heavy and tingly, tongue felt tingly, dry mouth, brain fog, mild trouble focusing, sluggish feeling; all lasting for about 10 minutes before subsiding, then came back in waves every few minutes. Dry mouth and tongue tingling stayed consistently for several hours, other symptoms subsided and came back in waves every few minutes, decreasing in frequency over a two hour period in which I was not allowed to leave the Health Department. Blood pressure and heart rate remained normal and consistent, irregular heartbeat noted at about 10 per minute with heart rate of 74-82 bpm (history of frequent PVCs, roughly 8% of heartbeats irregular previously) Symptoms improved significantly over 2 hour period and I was allowed to leave as long as someone else could drive me home, not allowed to return to work for the day.
35 2021-02-15 eye discomfort, eye pain The night that i received the shot it almost felt like i had a jolt of caffeine, i had a rough night... Read more
The night that i received the shot it almost felt like i had a jolt of caffeine, i had a rough night's sleep which i kept waking up in. I woke up Thursday 02/11 morning not feeling well at all, it felt like i had been hit by a train. I had a fever that has got up to as high as 101.3 (my normal temperature is 96 or low 97's so this is very unusual for me even when i get sick) fevers lasted until Saturday 02/13/21 in the morning, at which point I had been taking Tylenol and ibuprofen consistently so i stopped taking my temperature (If i were to stop taking those medications i feel i would maybe still have a temperature). I was so sore it hurt to move and walk, today (Tue 02/16) it doesn't hurt to walk finally. My arm pits hurt very bad and still slightly hurt. I have been very tired and weak as well. My eyes have hurt or felt different and appear glossy throughout all of this and still do.
35 2021-02-17 mouth tingling Tongue feeling fuzzy intermittently I took antihistamine Benadryl
35 2021-02-17 vision blurred Rash; blurred vision; loss of balance; headache; nausea; This is a spontaneous report from a contact... Read more
Rash; blurred vision; loss of balance; headache; nausea; This is a spontaneous report from a contactable other health care professional (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 27Jan2021 08:30 at single dose for Covid-19 immunization. The patient was not pregnant at time of vaccination. The Patient's medical history included Hbp (Blood pressure high). The Patient's concomitant medication included lisinopril, famotidine, and ferrous sulfate. The patient previously took Procardia and Amoxicillin; both experienced allergies. On 28Jan2021, the patient experienced rash, blurred vision, loss of balance, headache, and nausea. The patient did not received treatment for the events. The outcome of the events was recovering. The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in the Hospital. The patient did not tested for covid since vaccination.
35 2021-02-18 lacrimation increased At 50 hours post-vaccine, nausea began; vomited at 52 hours; weakness and nausea remained for an add... Read more
At 50 hours post-vaccine, nausea began; vomited at 52 hours; weakness and nausea remained for an additional 2 hours following vomiting; then for the next 6 hours, experienced chills and coldness in extremities to the point of pain; vomited again at 70 hours post-vaccine, leading to the onset of a severe, excruciating migraine; migraine lasted for 45 hours, accompanied by 14 hours of tears continuously leaking from eyes & nasal congestion; by the end of 5 days post-vaccine, all symptoms had subsided. No treatments were administered outside of ibuprofen (which seemed to have no effect) and a heating pad.
35 2021-02-18 pain in jaw I was fine the day I received the shot. The next day i was fatigued, but still worked through the d... Read more
I was fine the day I received the shot. The next day i was fatigued, but still worked through the day. I also had jaw soreness and the novacaine wore off. I went to bed at 7:30pm and slept 12 hours. day 2 post vaccine, i woke up with a swollen lymph node on my left side of the neck, felt sore, a little bit of a headache, but i felt rested.
35 2021-02-19 loss of taste, mouth numbness 2 weeks after second dose of vaccine received I noticed my left eye lazy and loss of taste and feeli... Read more
2 weeks after second dose of vaccine received I noticed my left eye lazy and loss of taste and feeling on left side of my tongue . As the day progressed I noticed my left side of face felt different number , my mouth was not opening wide on left side . I did a telemedicine call with a Dr that referee me to Er where I was diagnosed with Bell Palsy.
35 2021-02-21 ear itchiness ear pruritus in right ear, itchy skin just above affected ear on scalp, and skin behind affected ear... Read more
ear pruritus in right ear, itchy skin just above affected ear on scalp, and skin behind affected ear and just under ear on throat/neck. All related mild and just a little annoying but I was advised to report it all the same.
35 2021-02-21 mouth tingling, lip swelling Reports sensation of tingling and puffiness of lips starting about 2 hours after immunization, which... Read more
Reports sensation of tingling and puffiness of lips starting about 2 hours after immunization, which was still present the next morning. She did not visualize any change in her lips, and did not tell anyone about the reaction until it was time for her 2nd dose. She had previously tested positive for COVID in September and was not given a 2nd dose.
35 2021-02-22 eye pain Muscle and severe joint pain, lumbar, thoracic, and cervical spine pain (every vertebrae in my spine... Read more
Muscle and severe joint pain, lumbar, thoracic, and cervical spine pain (every vertebrae in my spine hurt like my car accident was yesterday), severe headache with horrible eye pain, nausea, injection site pain and arm weakness, sweating at night, diarrhea, sharp chest pains (like when I had covid), soft tissue between ribs hurt, gerd (reflux, over full feeling, gas, heartburn, sour stomach, pain when eating), extreme exhaustion, inability to do daily activities or go to work for one week
35 2021-02-22 vision blurred Approx 5 minutes after receiving the vaccine she started getting blurry vision. She says the next th... Read more
Approx 5 minutes after receiving the vaccine she started getting blurry vision. She says the next thing she knew she was lying on the floor and there were 2-3 people standing around her. She has a swollen lymph gland under her left arm. feels fine now. Dr gave her promethazine RX to take prior to her next dose.
35 2021-02-23 ear pain, dry mouth Dolor en el medio del craneo muy fuerte boca seca fiebre constante, dolor de oído diarreas
35 2021-02-23 swelling around the eyes maybe a little low iron but not too remarkable; swelling in middle finger of right hand/puffiness in... Read more
maybe a little low iron but not too remarkable; swelling in middle finger of right hand/puffiness in all of fingers and toes and around eyes; puffiness in all of fingers and toes and around eyes; she was not feeling great; fatigue; headache; soreness in her arm at the injection site; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her right arm, via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on 23Dec2020, she was not feeling great, had fatigue and headache. On 25Dec2020, she had swelling in her right middle finger, states that has now progressed to swelling in all her fingers, toes and around her eyes. Also reported that on 21Dec2020, she had soreness in her arm at the injection site that went away the same day. The patient also mentioned that she tested negative for Covid. The patient is also a little low iron but not too remarkable. The outcome of the event vaccination site pain was recovered in 21Dec2020, not recovered for peripheral swelling and puffy eyes while unknown for the other events. Information on Lot/Batch has been requested.
35 2021-02-24 dry mouth Difficulty swallowing, palpitations, dry mouth. Patient left and returned to parking lot and was ass... Read more
Difficulty swallowing, palpitations, dry mouth. Patient left and returned to parking lot and was assessed by the EMS-cleared
35 2021-02-24 ear pain, deafness Developed Bell's Palsy - started on 2/21/21 w/ ear pain and stiff neck, progressed to numbness and t... Read more
Developed Bell's Palsy - started on 2/21/21 w/ ear pain and stiff neck, progressed to numbness and tingling in face and lips on 2/22/21, then hearing loss and left sided facial paralysis. Went to ED, r/o stroke, neck/facial trauma. Given course of prednisone and acyclovir. No improvement noted to date.
35 2021-02-25 dry throat, dry mouth Within minutes after the vaccine I felt hot, removed my jacked but then I got chilled, my right hand... Read more
Within minutes after the vaccine I felt hot, removed my jacked but then I got chilled, my right hand begin itching which moved to the left hand. I was taken to the ER and was administed benedryl. I was transported to the hospital via ambulance because my mouth and throat was extremely dry and my voice got hardened. During the ride I regurgiatated because my stomach got queezy and was administered Zofran. My right hand turned completely white and I was administered another med to help turn my hand back right. My baby was checked and she was fine and was released after about 3 hrs. At that time I was 31 week gestation. Until about 3 days ago my body was still very very itchy all over which seemed to worsen when I was sleep.
35 2021-02-28 blindness Shingles outbreak on scalp, ears and face. Taking valtrex, neurontin, and prednisone. Also may have... Read more
Shingles outbreak on scalp, ears and face. Taking valtrex, neurontin, and prednisone. Also may have some loss of vision in right eye and instructed to use prescription eye drops 4 times a day for 3 weeks.
35 2021-03-01 eye irritation, eye pain, eye itchiness, dry eye On 2/26/21 my left eye started to itch, burn, and the eye felt drier than normal. On 2/27/21 there w... Read more
On 2/26/21 my left eye started to itch, burn, and the eye felt drier than normal. On 2/27/21 there was a noticeable red patch on the eyelid with small scaly looking spots, I assumed it to be a patch of dry skin. There was a 30 minute period of intense tingling pain and shooting/stabbing intermittent pain. There was also some numbness later on that day. Also on 2/27/21 I noticed a large lymphnode swelling on my jawline adjacent to my left ear. On 3/1/21 I saw my primary care provider and was diagnosed with shingles. After reviewing the preliminary symptoms of shingles, I had been experiencing abnormal fatigue and stomach upset for about 5 days prior to the eruption.
35 2021-03-02 taste disorder, dry mouth I've had too much stomach upset; Severe heartburn; Persistent mouth dryness; The taste in my mouth c... Read more
I've had too much stomach upset; Severe heartburn; Persistent mouth dryness; The taste in my mouth changed; Extreme fatigue; This is a spontaneous report from contactable healthcare professional. A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 27Jan2021 09:15 at single dose (left arm) for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. The patient was not pregnant. There were no concomitant medications. The patient had no other vaccine in other 4 weeks. On 28Jan2021, at 12:00, the patient experienced too much stomach upset, severe heartburn, persistent mouth dryness, the taste in mouth changed and extreme fatigue. The patient received therapy for the events included household medication and natural treatment. The patient did not have covid prior vaccination and was not covid tested post vaccination. Outcome of events was not recovered. Information on the batch/lot number has been requested.
35 2021-03-02 tunnel vision had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walkin... Read more
had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walking to bathroom and almost blacked out; Achy and restless legs; Achy and restless legs; nauseous however did not allow self to vomit; headache; fatigue; rapid heart beat; low grade fever; chills; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) via an unspecified route of administration on 16Feb2021 12:45 at single dose (left arm) for COVID-19 immunization. Medical history included hypothyroidism, and allergies: Sulfa. The patient was not pregnant. Concomitant medication included topiramate (TOPIMAX), metformin, levothyroxine, and phentermine. The patient received 1st dose of bnt162b2 for COVID-19 immunization on 26Jan2021, 12:45pm (lot EL9263). On 17Feb2021 03:30, the patient experienced achy and restless legs, nauseous however did not allow self to vomit, had tunnel vision ups on walking to bathroom and almost blacked out, headache, fatigue, rapid heart beat, low grade fever, and chills. The patient had no treatment for the events. The patient had no other vaccine in four weeks and had no covid prior vaccination. Patient was not covid tested post vaccination. Outcome of events was recovering.; Sender's Comments: A possible contribution role of the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of Tunnel vision cannot be completely excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-03-04 eye irritation severe swollen lymph nodes in left clavicle and left underarm; headache; burning/heat in eyes; fatig... Read more
severe swollen lymph nodes in left clavicle and left underarm; headache; burning/heat in eyes; fatigue / Third day had generalized fatigue; chills; fever; full body joint pain; nausea; muscle aches; heavy headed feeling; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 11:30 at a single dose for COVID-19 immunization. The first dose was received on 29Dec2020 (lot number: EL1284) on the left arm. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine and did not had any other medications within 2 weeks of vaccination. On 19Jan2021 13:30, 2 hours after vaccine, patient developed headache and burning/heat in eyes and fatigue. On the first night (19Jan2021), she had chills, fever, full body joint pain, nausea, muscle aches and heavy headed feeling. Next morning on 20Jan2021, she had severe swollen lymph nodes in left clavicle and left underarm. Second night on 20Jan2021, patient had fever, chills, muscle aches. Third day on 21Jan2021, she had generalized fatigue and ongoing severe lymph node swelling. No treatment was received. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. The reporter considered the events non-serious.
35 2021-03-04 swelling of eyelid Woke up this morning with some swelling on my left eye lid. Also very tender to the touch. It seems ... Read more
Woke up this morning with some swelling on my left eye lid. Also very tender to the touch. It seems slightly more tender now at the end of the day and a little more swollen than when I woke up
35 2021-03-04 ringing in ears I got the shot at 6:30pm. Drove, went to the grocery store, came home, did chores. Around 9:45 start... Read more
I got the shot at 6:30pm. Drove, went to the grocery store, came home, did chores. Around 9:45 started preparing for the next day (getting coffee pot ready, etc.) up until this moment I had no side effects except pain in my arm. Then at 9:45PM I began feeling light headed, ringing in my ears and fell unconscious. I woke up on my kitchen floor in a small pool of blood and disoriented. I do believe this reaction is related to the vaccine. I DO NOT have a history of fainting. I ate food and drank plenty of water throughout the day and after my vaccine injection. Everything about my day was typical except for the vaccination and losing consciousness.
35 2021-03-04 tongue itchiness, swollen tongue At Approximately 1040, patient (Age 35,) received her 2nd dose of Pfizer vaccine (Lot# 6200 Exp. 06/... Read more
At Approximately 1040, patient (Age 35,) received her 2nd dose of Pfizer vaccine (Lot# 6200 Exp. 06/2021). At approximately 1055, EMT was alerted by patient that she felt her tongue somewhat swollen and itchiness in the back of tongue, patient was sitting in observation chair at this time, A&Ox4. At approximately 1100, pt was moved to zero gravity chair, water was given, pt remained A&Ox4 and pink in color. Pt reported allergy to Penicillin- reaction Hives and also has seasonal allergies, with no past history of anaphylaxis. At approximately 1112, RN Lead spoke with patient and EMT about how patient is feeling, patient declined to have EMS called, patient was offered Benadryl, patient agreed and took Benadryl 25mg in 10ml Oral Solution. Vital signs at 1117: HR 74, RR 14, BP 130/90, Vital Signs at 1123 HR 70, RR 14, BP 128/90. At 1125, Patient claims symptoms not worsening. At 1128, tongue did not swell up more than initial complaint. At 1128, Pt stated she ?felt better? and left the facility, Pt A&Ox4, pink in color, ambulating with steady gait, driving herself in her vehicle. Pt verbalized understanding to call her doctor or 911 if she felt anything worsening.
35 2021-03-06 ear itchiness 1324 - Vaccine received 1354 - Observation time ended, but developed "itching" to bilateral ears (re... Read more
1324 - Vaccine received 1354 - Observation time ended, but developed "itching" to bilateral ears (reported to assessment tent at 1355). History of same plus "heat flushing" to face after 1st dose, which autoresolved without any meds within a few hours the first time. 1400 - HR 85, RR 18, BP 153/109, SpO2 100 1405 - Administered 25 mg PO Benadryl per MD verbal orders. 1410 - D/ced home w/ verbal instructions per MD.
35 2021-03-06 swollen tongue, burning mouth syndrome Swollen, very painful tongue that has lasted several days
35 2021-03-07 mouth swelling Swelling in soft pallet and oral mucosal membranes; Swelling in soft pallet and oral mucosal membran... Read more
Swelling in soft pallet and oral mucosal membranes; Swelling in soft pallet and oral mucosal membranes; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318) on right arm, via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS), tachycardia, epilepsy, allergies to penicillin, cherry and apple. The patient was not pregnant at the time of vaccination. Concomitant medications included spironolactone (ALDACTONE), celecoxib (CELEXA) and naproxen sodium (ALEVE). The patient experienced swelling in soft pallet and oral mucosal membranes on 02Feb2021. She took 2 doses of 25 mg diphenhydramine hcl (BENADRYL). One at onset and one at recurrence a few hours later. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. Therapeutic measures were taken as a result of swelling in soft pallet and oral mucosal membranes which included self-administered diphenhydramine hcl. The outcome of the events was recovering.
35 2021-03-08 mouth tingling, swollen tongue, lip swelling AFTER RECEIVING FIRST DOSE OF PFIZER COVID VACCINE, PATIENT ALERTED EMS THAT TONGUE AND LIPS FELT T... Read more
AFTER RECEIVING FIRST DOSE OF PFIZER COVID VACCINE, PATIENT ALERTED EMS THAT TONGUE AND LIPS FELT TINGLY/SWOLLEN. EMS NOTIFIED NP. NP BRIEFLY EVALUATED PT. PT DENIED DIFFICULTY SWALLOWING OR SOB. GAVE H/O ALLERGIC RXN TO RED DYE AND SULFA ANTIBIOTICS. NP REFERRED CARE TO MD AND EMS. EMS MONITORED AND GAVE 50 MG BENADRYL IM, FOLLOWED BY 0.3 EPINEPHRINE IM. PT, ACCOMPANIED BY FAMILY MEMBER, TRANSPORTED TO LOCAL HOSPITAL BY EMS.
35 2021-03-08 mouth tingling pt reports lip and tongue tingling. no chest tightness, SOB, or wheezing. Benadryl 25mg IM. pt feels... Read more
pt reports lip and tongue tingling. no chest tightness, SOB, or wheezing. Benadryl 25mg IM. pt feels improved no facial symptoms. reports now mild tingling in fingers. she would like to go home
35 2021-03-08 vision blurred, bloodshot eyes After receiving the second dose of Pfizer covid 19 vaccine on Monday, February 8, I did experience ... Read more
After receiving the second dose of Pfizer covid 19 vaccine on Monday, February 8, I did experience muscle aches, low grade fever and headache 24 hrs after the shot. Those symptoms lasted for about 3-4 days. Then on Sunday morning February 14 I work up with sciatic pain on my left leg. Then on Monday February 15 my right eye was red after I woke up that morning. Gradually during the week my eye continued to be red, blurry, and eventually cloudy Friday morning February 19. Found an eye doctor who could see me that morning. He diagnose me having Iritis and prescribed me durezol eye drops. I had to put one drop every 2hr until it gradually got better. I'm still under his care.
35 2021-03-09 eye swelling swollen eye; hives; This is a spontaneous report from a contactable Nurse, the patient. A 35-year-ol... Read more
swollen eye; hives; This is a spontaneous report from a contactable Nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via an unspecified route of administration on 11Jan2021 at 15:30 (at the age of 35-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included insulin resistance, vitamin D deficiency, GERD (Gastrooesophageal reflux disease) and allergy to pollen and possible allergy to cilantro. Prior to the vaccination, it was unknown if the patient was not diagnosed with COVID-19. Concomitant medications included metformin, famotidine (PEPCID [FAMOTIDINE]), clarithromycin (CLARITIN [CLARITHROMYCIN]), topirmate, and diphenhydramine hydrochloride (BENADRYL); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took pregabalin (LYRICA) from an unknown date for an unknown indication and experienced allergy. On 01Feb2021 at 06:00, the patient experienced hives and swollen eye. The patient reported that the first vaccine was administered and the patient was fine then the patient had hives and swollen eye on the day the second dose was to be administered. The second dose of the vaccine was delayed. The events resulted in an emergency room/urgent care visit and the patient received treatment for the events with solumedrol shot and prednisone oral with benadryl/pepcid/atarax. The patient received the second dose one week later, on Friday 05Feb2021, with prednisone on board. The clinical outcomes of the hives and swollen eye were recovering. It was also reported that since the vaccination, it was unknown if the patient had been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Hives cannot be totally excluded. The case will be reassessed if additional information becomes available.
35 2021-03-10 swelling of eyelid Swollen left eye lid - one side only
35 2021-03-12 ear swelling I was fine until exactly a week later. I started having itchiness and swelling in my ears, face and... Read more
I was fine until exactly a week later. I started having itchiness and swelling in my ears, face and throat. I took Albuterol and Benadryl at home. Then I went to the ER and they have me a steroid and Pepcid. I went home, and I was still very itchy. Then I went to urgent care and they repeated the treatment and I was fine by the 3rd day. I went to see my allergist and he wasn't sure if it was due to the vaccine. I was instructed to take the 2nd dose, but to take meds first. I took antihistamines before 2nd dose and I was fine.
35 2021-03-12 feeling of choking, eye irritation, eye pain, mouth tingling Slight sharp burning pain "behind" left eye begin a few hours after I had shot. That pain was interm... Read more
Slight sharp burning pain "behind" left eye begin a few hours after I had shot. That pain was intermittent for a few hours and dissipated by early evening of the day of the shot. My left lip and left side of throat had minor feeling of tingly burn when I was driving home 30 minutes after I had the shot. Stiff muscles on left side of neck. Intermittent mild muscle pinching along left side of body but went away by Friday night.
35 2021-03-12 feeling of choking 5 minutes after injection of the Pfizer vaccine I had a slight throat constriction and a tingling th... Read more
5 minutes after injection of the Pfizer vaccine I had a slight throat constriction and a tingling throat with a touch of nausea. I recovered after about 15 minutes.
35 2021-03-13 eye pain, bloodshot eyes Six days after receiving vaccine, began feeling unwell. Symptoms are extreme fatigue, red eyes, sore... Read more
Six days after receiving vaccine, began feeling unwell. Symptoms are extreme fatigue, red eyes, sore eyes, body aches, joint pain, pain around back/ribs, shortness of breath on exertion. Unable to do usual household tasks and requiring bedrest for much of the day. The symptoms are very similar to the waves of symptoms I experienced early on in Post-Acute Covid-19 syndrome. I got sick in March and was experiencing waves like this through November. Since November, my physical symptoms had abated and I had not suffered a major relapse like this, besides a mild relapse at end of January. My shortness of breath issues, back pain/rib pain, eye soreness are very specific symptoms that I associate with early on in my long covid experience. The vaccine seems to have triggered a major relapse in my long covid symptoms.
35 2021-03-13 lip swelling After several hours, my lips and throat began to swell, the next day, my lips were incredibly swolle... Read more
After several hours, my lips and throat began to swell, the next day, my lips were incredibly swollen and I could barely swallow , went to urgent care and was given an injection of a steroid which helped
35 2021-03-13 mouth tingling, tongue itchiness, feeling of choking Five minutes after vaccination, pt started having tongue and throat tingling, itchy and scratchy sen... Read more
Five minutes after vaccination, pt started having tongue and throat tingling, itchy and scratchy sensation. Denies chest pain, swelling, rash or sob.
35 2021-03-14 pain in jaw Abdominal and back rash - have tried creams to resolve itching and appearance. Still some on my back... Read more
Abdominal and back rash - have tried creams to resolve itching and appearance. Still some on my back. Abdomen rash has cleared. Chest pain, right sided. Pain through jaw and shoulder. Felt as if I pulled a muscle. Slept a few hours and it was gone; had it not been gone when I woke up, I would?ve went to the ER.
35 2021-03-14 sensitivity to light, lacrimation increased Experienced moderate headaches everyday for 7 days following first series of vaccine. (NDC el9263) O... Read more
Experienced moderate headaches everyday for 7 days following first series of vaccine. (NDC el9263) On day 7, woke up in the middle of the night with intense nausea and headache. First thought to have food poisoning because husband who received the same vaccine also had similar symptoms. Both vomited multiple times and experienced severe headaches. After second series of vaccine (NDC en 6201), experienced headaches everyday again which required in taking multiple doses of ibuprofen. On day 7, woke up in the middle of the night with intense headache. Developed intense nausea, headache, neck pain, stiffness, light sensitivity, watery eyes, congestion and could not continue to work. Took multiple doses of advil and had to take off work. No vomiting occurred. Did not see a physician but consulted a coworker/neurologist friend who thought I fit the description of aseptic meningitis. No lumbar puncture or laboratory evaluation was done. Rechallenge was positive.
35 2021-03-15 mouth tingling, swollen tongue At 3:47 pm (36 minutes after receiving shot) tongue swelled lips tingled, increased heart rate, and ... Read more
At 3:47 pm (36 minutes after receiving shot) tongue swelled lips tingled, increased heart rate, and extremities shook. Called 911 at 3:50 pm. Fire department came and blood pressure was high, heart rate was high, blood sugar was low. Fire fighter noticed hives on right shoulder (shot was administered in left arm) and they could see hives spreading across chest and neck. Hives covered upper torso but did not spread to abdomen or legs. Tongue swelled more making speech difficult. Breathing was easy, no constriction or wheezing heard through stethoscope. Vitals taken 2 or 3 more times, becoming more regular each time. Fire fighters provided Gatorade and discussed options. Fire department left at 4:10. I took Benadryl and Pepcid at 4:15. Tongue swelling decreased around 6 pm, but remained slightly swollen until 3/14/21. Hives visible and itchy until 3/15/21. Other symptoms included fatigue, dizziness, body aches. Triamcinolone was used topically on hives twice daily on 3/13/21 and 3/14/21.
35 2021-03-17 eye strain Severe chills (teeth chattering and shaking), temperatures ranging from 101.5-103.0 throughout the d... Read more
Severe chills (teeth chattering and shaking), temperatures ranging from 101.5-103.0 throughout the day (2 am - current time 2:45 pm), severe fatigue and body aches (trouble standing and opening eyes), bluish fingernail beds with numbness and tingling to knocking knuckles. 2x taken excedrin which did break fever first time for temporary relief. Moving arms and fingers to encourage circulation.
35 2021-03-17 double vision On March 2nd I received the first dose of the vaccine. On March 5th I began to feel poorly and run ... Read more
On March 2nd I received the first dose of the vaccine. On March 5th I began to feel poorly and run low grade fever. On March 6th, I suddenly developed double vision. The low grade fever and feeling poorly (other than fatigue) subsided around March 7-8; however, the double vision persists. It is very difficult to focus at times and drive and perform some other activities that require visual focus at medium to far distances.
35 2021-03-17 vision blurred, ringing in ears On 1/19/21- visual migraine, severe fatigue, difficulty concentrating. These symptoms continued alon... Read more
On 1/19/21- visual migraine, severe fatigue, difficulty concentrating. These symptoms continued along with blurry vision, dizziness, waking at night to ?buzzing? in head, hypoglycemic symptoms. Multiple doctors visits over the past two months, blood tests, BP and heart rate assessments - only to assume it?s a reaction to the vaccine. Extreme diet change, elimination of the two prescribed meds and detox- feeling much better however still experiencing hypoglycemic symptoms throughout the day and sometimes at night.
35 2021-03-18 mouth numbness Within about two minutes my head started feeling "off", my mouth started to go numb, my heart starte... Read more
Within about two minutes my head started feeling "off", my mouth started to go numb, my heart started to race, my face started itching/sweating and I could feel a headache coming on. I had a headache, chills, fatigue, increased body temperature (2+ degrees) and a sore arm for the rest of the day. I woke up this morning with a really sore arm. I could only lift my arm halfway up, due to the deep muscle pain.
35 2021-03-18 mouth tingling, mouth numbness Allergic response to Pfizer Covid Vaccine #1, resulting in immediate numbness and tingling in face a... Read more
Allergic response to Pfizer Covid Vaccine #1, resulting in immediate numbness and tingling in face and mouth, dry cough and tightness in throat. Hives present after 6 hours. Symptoms were controllable with benadryl for the first 6 hours, but became uncontrollable 6 hours after the vaccine. Patient went to Emergency Room to control symptoms.
35 2021-03-19 loss of taste, loss of smell I tested positive for COVID on January 24th. I never had a fever throuhgout my illness; however I d... Read more
I tested positive for COVID on January 24th. I never had a fever throuhgout my illness; however I did have mild cold symptoms, and lost all sense of taste and smell. My taste and smell just started to return a few weeks ago. I received the Pfizer vaccine on Friday, March 12th. On Monday, March 15th, I lost all smell and taste. When I completed a virtual care visit, I was advised that since I had COVID within the past 12 weeks, I was not eligible to be retested for COVID. However, I was informed that loss of taste and smell were not side effects of the vaccine and that I needed to go home and quarantine for 2 weeks. I requested a second opinion, and was instructed from my second opinion to get retested (although this was against routine CDC guidelines). My retest was negative for COVID. I have been advised that my loss of taste and smell should be reported to the CDC as a side effect of the vaccine. I still do not have taste or smell as of March 20.
35 2021-03-20 taste impairment Day of vaccine: fatigue, sore arm at injection site, at 10pm: metallic taste Day after vaccine: Feve... Read more
Day of vaccine: fatigue, sore arm at injection site, at 10pm: metallic taste Day after vaccine: Fever 99.5 for ~2 hours, extreme clumsiness/lack of full control of appendages, muscle aches, and fatigue all day. Sore arm (injected arm), intermittent headaches. At 10pm: swollen lymph node (size of cherry tomato of injected arm). For the next 9 days: arm tingling, as if nerve(s) were pinched, when trying to extend or stretch straight (injected arm) Symptoms caused fair/tolerable discomfort, but not severe.
35 2021-03-22 painful gums First day arm pain shoulder and a bit chest pain. Gun pain too. Next day still arm pain.
35 2021-03-22 taste disorder, mouth tingling Metallic taste in mouth, tingly feeling in tongue. Started about an hour or two after receiving the... Read more
Metallic taste in mouth, tingly feeling in tongue. Started about an hour or two after receiving the vaccine and lasted for roughly 24 hours.
35 2021-03-24 inability to speak Pt states: five minutes post inoculation, developed lightheadedness, body aches, the inability to mo... Read more
Pt states: five minutes post inoculation, developed lightheadedness, body aches, the inability to move, and the inability to speak for a few minutes - states episode may have been anxiety. Palpitations
35 2021-03-24 ear pain Gradual onset Bell?s Palsy. Left side facial paralysis (partial), intermittent ear and facial pain. ... Read more
Gradual onset Bell?s Palsy. Left side facial paralysis (partial), intermittent ear and facial pain. Onset at 39+6 days pregnant.
35 2021-03-24 mouth tingling Day 1: Tingling in feet, strongly in left foot. Day 4: Constant hot flashes, dizziness, vertigo Sin... Read more
Day 1: Tingling in feet, strongly in left foot. Day 4: Constant hot flashes, dizziness, vertigo Since day 4, there have been hot flashes and dizziness, muscle weakness, diarrhea and tingling of hands, feet, and lips to varying degrees. Yesterday, day 12, my left side of my face started to tingle as well and felt some numbness. My pinky finger on my left hand started twitching. They have continued to tingle and twitch since.
35 2021-03-25 taste impairment, taste disorder, loss of taste Had loss of taste, weird/altered taste, metallic taste in my mouth Friday afternoon through mid-morn... Read more
Had loss of taste, weird/altered taste, metallic taste in my mouth Friday afternoon through mid-morning/early afternoon Saturday.
35 2021-03-25 ear infection, ear discomfort Fullness in inner ears, ear discomfort, lightheadedness, dizziness, vertigo-esque symptoms for about... Read more
Fullness in inner ears, ear discomfort, lightheadedness, dizziness, vertigo-esque symptoms for about a week to 10 days. Significantly/moderately severe for 4 days, then gradually lessening.
35 2021-03-25 mouth ulceration sore throat and sore in mouth, on tonue, and on throat
35 2021-03-25 vision blurred patient reported blurred vision, and facial redness and swelling around the cheeks. Blood pressure w... Read more
patient reported blurred vision, and facial redness and swelling around the cheeks. Blood pressure was also found to be elevated.
35 2021-03-26 dry mouth Next day began a fever of 101.3 to 102.5, felt hit by a truck. Sore throat, nausea, vomiting, body... Read more
Next day began a fever of 101.3 to 102.5, felt hit by a truck. Sore throat, nausea, vomiting, body aches, swollen joints, headache and migraine. Loss of appetite and loss of desire to hydrate. Lasted over 5 days. Took my routine pain meds, percocet, tylen rapid release gels alternating with generic excedein tension headache. Lots of hot baths, humidifier at night for my severe dry mouth.
35 2021-03-26 toothache, pain in jaw Flu like symptoms including fever, chills, fatigue, body aches started after 12 hours and lasted for... Read more
Flu like symptoms including fever, chills, fatigue, body aches started after 12 hours and lasted for 36 hours. Then hives and flushing on day 2-3, intermittently. Swollen lymph nodes in armpit, neck, groin, jaw and tooth pain. Continuous headaches, congestion, and worsening fatigue for weeks. At week 3, started having increased shortness of breath, nocturnal hypoxemia, cough, chest tightness, fatigue, increased heart rate with exertion. These symptoms worsened over the next three weeks.
35 2021-03-27 mouth tingling Tingling mouth and tongue. Flushing feeling
35 2021-03-28 loss of taste, eye swelling, eye discharge, loss of smell My allergies flared the next day by way of discharge from one eye that was swollen by the evening. I... Read more
My allergies flared the next day by way of discharge from one eye that was swollen by the evening. I had evening headaches. I was able to get that eye discharge and swelling under control and then that weekend (5 days later I had nonstop headaches and was beginning to have sinus congestion. On Sunday (day 6) I had lost my sense of smell but had a very runny nose. On Monday I lost my sense of taste. I slowly started to improve over then next few days after taking mucinex and Flonase.
35 2021-03-28 swollen lips, lip swelling Swollen and a rash in my lips.
35 2021-03-29 loss of smell Patient started to develop congestion and loss of smell on 03/21/2021. Patients husband tested posit... Read more
Patient started to develop congestion and loss of smell on 03/21/2021. Patients husband tested positive with Covid rapid test in the urgent care the following day on 3/22/21. Patient then came into urgent care clinic for screening from exposure from husband.
35 2021-03-29 drooling 1350:C/O tightness in throat, headache, excessive saliva in mouth. B/P 126/78, SPO2-100%, Pulse-59. ... Read more
1350:C/O tightness in throat, headache, excessive saliva in mouth. B/P 126/78, SPO2-100%, Pulse-59. 1400 Given 0.3mg epinephrine IM in right anterolateral thigh, given by nurse. 1405:911 called for transport to ER for observation, vital signs followed: B/P 136/78, SPO2-100%, Pulse-62, Resp--20. 1410 Rescue Fire Department arrived. Assessment done by lead rescuer. Patient declined transport to ER via Rescue Unit. Traveled to ER via private vehicle.
35 2021-03-29 swollen tongue, mouth tingling Tongue swelling and tingling; throat swelling.
35 2021-03-30 ringing in ears, deafness unilateral, ear discomfort, ear pain, hearing loss developed left sided facial paralysis; some findings of inflammation on the 8th nerve; developed uni... Read more
developed left sided facial paralysis; some findings of inflammation on the 8th nerve; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; ear discomfort; ear discomfort that worsened; progressed to mild hearing loss; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: EN5318), via an unspecified route of administration, administered in the left arm on 11Feb2021 08:15 at a single dose (at the age of 35-years-old) for COVID-19 immunisation; vaccinated in a hospital. Medical history was not reported. No known allergies. Concomitant medication included escitalopram. The patient had no other vaccine in four weeks. The patient did not have COVID prior to vaccination. Six days after the vaccine (17Feb2021), the patient developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus, which then progressed to mild hearing loss. After about 7 days of ear discomfort that worsened (2 weeks exactly after first dose of vaccine), the patient developed left sided facial paralysis. The patient was seen by ENT, had a full workup including hearing test and head MRI with contrast. Came back normal aside for some findings of inflammation on the 8th nerve. The patient was placed on acyclovir 500mg 3x a day for 7 days and 60 mg of prednisone for 7 days with a 9 day taper. The facial paralysis completely recovered after 2-3 full weeks. The ear was mostly recovered with some residual tinnitus. The patient was not COVID tested post vaccination. The patient required a visit to the doctor and emergency room for the events. The patient recovered from left sided facial paralysis in Mar2021. The patient was recovering from the remaining events.; Sender's Comments: Considering plausible temporal association and lack of alternative explanations, the events left ear hearing loss, inflammation on the 8th nerve, and left sided facial paralysis are possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
35 2021-03-31 lip itchiness Patient complained of itching of lips 8 minutes after receiving vaccine. No rash noted on lip or ins... Read more
Patient complained of itching of lips 8 minutes after receiving vaccine. No rash noted on lip or inside mouth. 25mg PO Benadryl given. 20 minutes later patient stated she is itchy on stomach, back and legs. No rash noted. Additional 25mg PO benadryl given. Patient monitored additional 30 minutes. Patient did not have any sign of respiratory distress. Sitting in chair speaking in clear sentences. Patient able to walk without assistance. Patient got a family friend to take her home she did not drive home. Patient walked out of building on her own.
35 2021-04-01 taste impairment - Moderate arm tenderness beginning about four hours after injection and last for about 48 hours. - ... Read more
- Moderate arm tenderness beginning about four hours after injection and last for about 48 hours. - Extreme fatigue beginning about four hours after injection and lasting about 24 hours before decreasing to moderate fatigue for another 24 hours. - Metallic taste in mouth beginning about half an hour after the vaccine and lasting about two hours. - Skin striations on the arm that received the injection beginning about 4 hours after the injection and lasting about 3 hours.
35 2021-04-01 ear discomfort After about 7-10 minutes I began to feel warm. The nurse asked me to remove my mask and I had a rash... Read more
After about 7-10 minutes I began to feel warm. The nurse asked me to remove my mask and I had a rash and hives on my neck, face and chest. I was taken to a room and given Benadryl and ice packs while my vitals were monitored. My ear turned bright read and burned so badly that they had to get ice for my ears as well. I was shaking and felt dizzy. After 15 minutes I was feeling worse and my ears were on fire. After listening to my chest the nurse called for an ambulance in case she needed to administer an epi pen. The ambulance arrived and I was taken out to be evaluated. This was around 40 minutes after being given Benadryl and it began to work. I was advised that being seen at the hospital would be a good idea but that all my vitals were back to normal but the rash and hives were still there. I decided not to go to the hospital and to see if the Benadryl continue to work. After about 1.5 hours after Benadryl my hives and rash have gone away mostly.
35 2021-04-01 eye pain, toothache Headache, eye pain, chills, joint pain, high fever (103.2 ° F), tooth pain, nausea, raised and itch... Read more
Headache, eye pain, chills, joint pain, high fever (103.2 ° F), tooth pain, nausea, raised and itchy tattoos.
35 2021-04-01 mouth discomfort, lip swelling Pt reports swelling and erythema around lip and burning one hour after administration of vaccination... Read more
Pt reports swelling and erythema around lip and burning one hour after administration of vaccination with worsening redness and swelling to lips 3 hours after administration
35 2021-04-01 photosensitivity reaction severe migraine (sometimes causing rainbows in my peripherals), fatigue, chills, occasional fever, s... Read more
severe migraine (sometimes causing rainbows in my peripherals), fatigue, chills, occasional fever, sun sensitivity (bad sunburn in only minimal sun exposure that isn?t healing), my skin keeps turning splotchy with burning and itching sensations and blistering (my face, hands and feet mostly), high blood pressure, bruising easily, dizziness, memory loss, swelling, body aches, muscle cramps in places i didn?t know I could have them, vaginal bleeding for 2 weeks after, nausea, vomiting, stomach cramps. I?m sure I?m forgetting some stuff. They keep just saying it?s a multi system immune response. I had my second shot on 3/5 and haven?t had relief since.
35 2021-04-02 mouth tingling, mouth itchiness COATING OF THE TONGUE itching and tingling around the mouth feeling warm 'flushing exam - wnl
35 2021-04-03 taste impairment During the 15 minute post-vaccination period patient reported a metallic taste in her mouth that sta... Read more
During the 15 minute post-vaccination period patient reported a metallic taste in her mouth that started a few minutes after vaccination. She stated that other than that and some soreness at he injection site she was otherwise fine. She went on to state that she already noticed that the metallic taste was starting to dissipate, even after only a few minutes. I informed patient that arm soreness is normal and that a metallic taste is rarer, but still a potential side effect and to continue monitoring the situation and to contact us or her doctor if anything changes.
35 2021-04-03 mouth tingling, tongue discolouration Tightness around tongue 15 minutes after vaccination. About 45-50 minutes after vaccination a nickel... Read more
Tightness around tongue 15 minutes after vaccination. About 45-50 minutes after vaccination a nickel size red splotch appeared on top of tongue. 50mg of Benadryl was taken and within a few hours symptoms subsided.
35 2021-04-04 swollen tongue tongue swelling, itching
35 2021-04-05 deafness unilateral On March 28, I woke up completely deaf in my right ear. Over the days it has been improving very lit... Read more
On March 28, I woke up completely deaf in my right ear. Over the days it has been improving very little. And my hearing hasn't fully returned until today. I do not feel pain, being noises, beeps all the time that do not let me understand.
35 2021-04-05 mouth tingling Headache immediately upon injection. Tingling in arbs within first 2 minutes. Subsided after 10 minu... Read more
Headache immediately upon injection. Tingling in arbs within first 2 minutes. Subsided after 10 minutes. It continued to come and go all day. Tongue tingling and swelling at 30 min mark. Took Benadryl after one hour of onset swelling. As of 24 hours post vacc, some tingling and swelling is still present.
35 2021-04-05 ringing in ears Woke up in the middle of the night feeling feverish and nauseas. Developed a ringing in my ears befo... Read more
Woke up in the middle of the night feeling feverish and nauseas. Developed a ringing in my ears before vomiting for several minutes, followed by chills. Felt better going back to bed. This morning my arm is sore.
35 2021-04-08 lip swelling Swollen left side of face, swollen lips, it happened within 5 minutes of receiving injection (same s... Read more
Swollen left side of face, swollen lips, it happened within 5 minutes of receiving injection (same side as injection).
35 2021-04-08 sensitivity to light Patient at Vaccine Clinic on 4/9/2021. Patient had received her second dose of COVID-19 vaccine (P... Read more
Patient at Vaccine Clinic on 4/9/2021. Patient had received her second dose of COVID-19 vaccine (Pfizer). She noted dizziness. She was able to walk to the Adverse Reaction Area and noted headache and sensitivity to light. Disposable pillow case was given to the patient to cover her eyes. Vital signs: 11:42 am: Blood pressure 231/141, heart rate 99, while sitting We asked the patient to lay down on the gurney. 11:55 am: Blood pressure 210/132, heart rate 94 11:56 am: Blood pressure 208/140, heart rate is 95 Patient felt slightly better and looked better, but the recommendation was for her to go to the ER as her blood pressure was significantly high. We discussed the risks of stroke and/or heart attack. Patient declined ambulance transport, and she and her husband agreed to go to the ER. Her husband agreed to drive her to the ER. I called ER triage desk and alerted them that the patient would be going to the ER. The patient and her husband understand this. All questions were answered.
35 2021-04-09 eye swelling 24 hours after the injection I got swollen eyes. This is exactly what happens to me when I use a pro... Read more
24 hours after the injection I got swollen eyes. This is exactly what happens to me when I use a product (lotion, soap, etc.) so I?m assuming it?s my immune response. The swelling mostly went away 24 hours after onset (48 hours after shot).
35 2021-04-09 ringing in ears, hearing loss, ear discomfort pressure in her ears; right ear was burning; almost passed out; dizzy; hot; couldn't hear everything... Read more
pressure in her ears; right ear was burning; almost passed out; dizzy; hot; couldn't hear everything sounded really far away; had impaired thinking, couldn't think straight; no concentration for two days straight; had buzzing in her ears and heightened sounds; pins and needles sensation in her feet that went up to her legs/on day 9 the pins and needles sensation seems to be in her hands and arms as well; This is a spontaneous report received from a contactable consumer (patient). A 35-year-old female patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 18Mar2021 at age of 35-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated she received the first dose of the Pfizer COVID vaccine on 18MAR 2021. She stated ten minutes after the vaccine on 18Mar2021 she became dizzy, hot, almost passed out, couldn't hear everything sounded really far away. Patient stated this lasted for 20 minutes. Patient stated she also had impaired thinking, couldn't think straight and no concentration for two days straight. She stated she also had buzzing in her ears and heightened sounds for three days. She stated she had pins and needles sensation in her feet that went up to her legs. She stated on day 9 the pins and needles sensation seems to be in her hands and arms as well. Patient stated yesterday (26Mar2021) her right ear was burning and today (27Mar2021) she has pressure in her ears in addition to the pins and needles sensation. Events were reported as non-serious. Patient would like to know if her symptoms have been reported or are normal. She would like to know how long will her symptoms last and if they are permanent. She would like to know if she should receive the second dose of the vaccine. She would like to know what treatment she should have for her symptoms. She would like to know if there were any reports of autoimmune diseases being diagnosed after receiving the vaccine. She would like for someone to notify her if any information or data becomes available regarding the side effects she has mentioned that were not mentioned in the FactSheet. No information in PI regarding impaired thinking, loss of hearing, heightened hearing, pins and needles in extremities, and burning and pressure in ears. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. No information in PI regarding autoimmune disorders being diagnosed after receiving Pfizer COVID vaccine. Outcome of dizzy, hot, almost passed out, couldn't hear everything sounded really far away was recovered on 18Mar2021, of had impaired thinking, couldn't think straight, no concentration for two days straight, buzzing in her ears and heightened sounds for three days was recovered in Mar2021, of the other events was unknown. Information on the lot/batch number has been requested.
35 2021-04-09 ringing in ears Tinnitus both ears-mild
35 2021-04-09 vision blurred, ringing in ears I had absolutely no symptoms prior to receiving the vaccination. After receiving the injection, I wa... Read more
I had absolutely no symptoms prior to receiving the vaccination. After receiving the injection, I was directed to an extended 30 minute waiting area due to existing health conditions (MCAS). Within the first five minutes I began to feel strange pvc-like cardiac sensations in my chest (which I have not had for almost a year until now). Additionally, I began to feel quite dizzy, like I might pass out, and had immediate brain fog. I told the attending nurse that came to check on me and she called the on-site physician over to do a check up. I was told I seemed flushed on my chest and neck but I couldn't feel much at the time, so we weren't sure if it was related. I was given a snack and water after the clinician asked if I may need to eat. I also took my afternoon beta-blocker a little early as a preventative measure. I began to feel quite hot and symptoms continued until the 30 minute window was up. My pulse was stable, however I was repeatedly asked if I wanted to call EMS services to the center (there weren't any on site due to time of day). Since my symptoms weren't seeming to get any worse and I didn't want to go to the hospital, I decided to carefully drive myself home. After leaving the clinic, my cheeks began to flush a very bright red, along with both ears, which were a dark reddish-purple. I began to experience a headache but no other symptoms. Later that night I began to feel very tired and generally unwell. I experienced increased muscle pain and fatigue along with multiple strange, vivid dreams. This morning (the following day), I have felt extremely fatigued. I've experienced headache, tinnitus, dizziness, as well as a disturbing feeling of pressure from my chest down to my lower abdomen, and blurry vision (that began in the afternoon). I have had several episodes of severe brain fog and hot flashes.
35 2021-04-10 loss of taste, loss of smell Site soreness started a few hours after injection, then spread throughout body. Woke up in the middl... Read more
Site soreness started a few hours after injection, then spread throughout body. Woke up in the middle of the night with nausea, vomiting, body aches, and headache. Vomiting and body aches lasted about 48hrs, but nausea and headache continued with the addition of stomach cramps and diarrhea. Stomach cramps and diarrhea lasted about 8hrs while headache and nausea persisted. Lost sense of smell and taste, still experiencing mild headache and nausea.
35 2021-04-11 loss of taste, loss of smell Received 2nd dose of Pfizer COVID vaccine 1/8/2021. 4/6/2021 individual developed fever, chills... Read more
Received 2nd dose of Pfizer COVID vaccine 1/8/2021. 4/6/2021 individual developed fever, chills, cough, headache, rhinorrhea, and loss of taste/smell. Tested positive for COVID.
35 2021-04-11 smell distorsion When going to bed- fever, chills, intense headache. Intense dreams. Took 400mg Ibuprofen at 5am, wen... Read more
When going to bed- fever, chills, intense headache. Intense dreams. Took 400mg Ibuprofen at 5am, went back to fitful sleep. Saturday- Woke up around 9am, still feverish, bad headache, no hunger, no thirst. Nausea. Took 400 mg Ibuprofen. Drank some water, went back to bed. Intense sense of smell. Midday took a kaopectate pill, tried to eat a cracker, drank some gingerale and water. Threw up at 3pm and 5pm. Severe nausea, could not drink a lot. Sunday- Slept through the night (still had fever). Woke up drenched, headache gone, still not hungry, throat sore. Drank tea. Slept more. 5pm started to feel better, felt hunger. ate 6 saltines and a bowl of brothy soup (water based veggie). Lower fever, took 500mg Acetaminophen. Monday- Slept through the night, woke up, still have a sore throat, very sore shoulder and arm pain (injection arm). Still very drowsy, but feeling better.
35 2021-04-12 ear discomfort, ringing in ears, ear pain Ear ache, followed by constant tinnitus and extreme clogged muffled feeling.
35 2021-04-12 mouth swelling, mouth itchiness Phone call with client after she cancelled her dose 2 appointment. She states that within 3 hours of... Read more
Phone call with client after she cancelled her dose 2 appointment. She states that within 3 hours of dose 1 Pfizer, she had generalized hives which progressed to throat & mouth swelling & itching. She took Diphenhydramine & Zyrtec. She also has been in regular contact with her PCP who has her taking Zyrtec daily. The hives continue & she states they've "started resembling chigger bites". They seem to improve but she scratches them to the point of bleeding/breaking the skin. Her PCP told her not to get the 2nd dose & called this a "near anaphylactic reaction". She will wait several months before considering getting the Janssen vaccine, but for now she's content with the level of coverage one dose provides. I asked her to continue to stay in touch with her PCP & advised that she may need some steroids should this skin reaction continue. She verbalized understanding. Her dose 2 appointment is cancelled.
35 2021-04-12 ringing in ears, vision blurred, deafness Woke up at 3am with the worst nausea and stomachache of my life. tried to get to the bathroom. all o... Read more
Woke up at 3am with the worst nausea and stomachache of my life. tried to get to the bathroom. all of a sudden had massive ear ringing in my left ear and then everything just went out. my hearing. my vision started to blur, saw black spots. Couldn't speak. felt cold all over and then started pouring sweat from my forehead. Ripped off my sweatshirt and laid in bed until it passed about 20 minutes later.
35 2021-04-12 ringing in ears, visual impairment 10 days out from vaccine and still have major dizziness, lightheaded, visual changes, major head ach... Read more
10 days out from vaccine and still have major dizziness, lightheaded, visual changes, major head aches, and if headaches get bad enough then ringing in ears.
35 2021-04-13 mouth numbness, mouth pain Doctors believe my wife has developed Gillian-Barre Syndrome as a result of the covid vaccine. We ha... Read more
Doctors believe my wife has developed Gillian-Barre Syndrome as a result of the covid vaccine. We have visited the ER, 2 different Nuerologist, 2 different Internalist, a eye specialist (optometrist) and today the a spine Center. Healthy 35 year old pre vacine, post-first vaccine shot developed numbness and shooting pain in feet, it has spread to fingers, mouth and rectum. Eye prescriptions have changed drastically in last 3 weeks, extreme weight loss (down 20lbs), insomnia
35 2021-04-13 mouth numbness When patient presented for her second Pfizer dose, she reported that about two hours after receiving... Read more
When patient presented for her second Pfizer dose, she reported that about two hours after receiving her first dose, she experienced a sensation of numbness of her tongue that lasted for about two hours. She denied any swelling of her lips or tongue, or any other symptoms. She reported that she could still taste. The sensation self-resolved. Given that this was a public health clinic site with limited medical capabilities, we referred her to receive her second vaccination in a medical setting.
35 2021-04-13 ringing in ears Tinnitus
35 2021-04-14 dry mouth, mouth tingling Event & symptoms 1820 Hives and redness on arms, neck, chest. Dry mouth, dizzy, slight SOB, "tongue ... Read more
Event & symptoms 1820 Hives and redness on arms, neck, chest. Dry mouth, dizzy, slight SOB, "tongue feels fat" 1830 Hives less on arms, same on neck. 1837 Ears feel hot, chest less red, no SOB. Pt reports feeling dizzy, shaky Treatment & outcomes: 1820 - Benadryl 25 mg 2 caps 1845: Fire Department called for paramedic assistance. Patient left clinic with sister to ambulance
35 2021-04-14 eye swelling The next evening following the vaccine, my right eye swelled (the white of the eye) and my cheek and... Read more
The next evening following the vaccine, my right eye swelled (the white of the eye) and my cheek and above my eyebrow became inflamed on the right side only. I visited the ER the next morning and they told me it looked like an unrelated allergic reaction. She said it looked almost like the pattern of shingles but said that was unlikely. Visited another dr who said it looked like the possible beginnings of shingles based on the affected areas and that I should monitor. Face feels hot, eye swelling went away after Benadryl use the first night but cheek and eyebrow are still inflamed.
35 2021-04-14 feeling of choking Patient received dose 1 of the Pfizer vaccine and while in the waiting area, she experienced dizzine... Read more
Patient received dose 1 of the Pfizer vaccine and while in the waiting area, she experienced dizziness, nausea, and difficulty breathing with tingling in her throat. Her husband requested assistance. Onsite medical staff state patient?s arms and face turned red and she appeared to stop breathing, while they were speaking with her. Epinephrine was administered at 1319 and EMS was immediately.
35 2021-04-14 thirst About 10 hours after dose 2, full onset of symptoms including - chills, hot/cold, flu-like symptoms,... Read more
About 10 hours after dose 2, full onset of symptoms including - chills, hot/cold, flu-like symptoms, extreme shaking, dizziness, nausea, diarrhea, fever, inability to stand, exhaustion, heart racing (watch indicated 135 beats per minute), parched, headache, extreme radiating pain in head, neck, shoulders, pain in toes and ankles, muscle aches
35 2021-04-14 enlarged tonsils Patient reports tingling within a minute of administration and spreading sensation and numbness dow... Read more
Patient reports tingling within a minute of administration and spreading sensation and numbness down her arm to her fingers. Patient stayed in store for 15 minutes, then an additional 15 minutes due to the development of the adverse event. When patient left in her car, she started feeling a little warm. After 5 or 10 minutes she felt a discomfort and eventual "lump in her throat". Throat tightness ensued similar to an asthma attack, producing a deep ruby red in back of throat with tonsils swollen. Patient pulled over, experiencing lightheadedness. Patient describes this as an anaphylactic response. Her reaction did not worsen but did not immediately improve. Patient was on phone with husband until arriving home. She then took a diphenhydramine (about an hour and 15 minutes after the administration of the vaccine). Her throat discomfort started getting better but arm pain worsened, numbness turning to pain. Patient went to doctor on 4/15 at about 11:30am. Patient main issue was arm pain with restricted range of motion at time of dr's visit. Throat was improved but less severe. Dr instructed her to not take second dose.
35 2021-04-15 deafness, hearing loss Loss of Hearing on left side. Right side was tremendous pressure. "Whoosing" sounds for 24 hours. ... Read more
Loss of Hearing on left side. Right side was tremendous pressure. "Whoosing" sounds for 24 hours. Finally has day progressed hearing came back on left side but still feel pressure feeling on right side. Never had any ear problems before.
35 2021-04-15 dry mouth Fever, Sweating, ar pain, dry mouth, chills and body pain.
35 2021-04-15 mouth numbness, mouth tingling Within 3 minutes of receiving the vaccination my Tongue began to tingle and then I began to lose fel... Read more
Within 3 minutes of receiving the vaccination my Tongue began to tingle and then I began to lose felling in it. This is normal to me consuming almonds. I took a Benadryl and it helped.
35 2021-04-15 lip swelling, lip itchiness, tongue itchiness Itchiness, puffy lips, puffy face, rash, itchy tounge tongue lips. Given benadryl took more on the w... Read more
Itchiness, puffy lips, puffy face, rash, itchy tounge tongue lips. Given benadryl took more on the way home and taken steroid to help lessen rash and swelling
35 2021-04-15 swollen tongue facial papular pruritic eruption with subsequent posterior tongue swelling wit mitigation by oral a... Read more
facial papular pruritic eruption with subsequent posterior tongue swelling wit mitigation by oral antihsitamines benadryl when added to daily zyrtec.
35 2021-04-16 lip blister Blister formed on bottom lip the day after vaccine was giving. No history of cold sores or fever bli... Read more
Blister formed on bottom lip the day after vaccine was giving. No history of cold sores or fever blisters
35 2021-04-16 bloodshot eyes Extreme fatigue starting at 12pm. Elevated fever reaching 103.2 by 2am, down to 101.4 by 6am, not br... Read more
Extreme fatigue starting at 12pm. Elevated fever reaching 103.2 by 2am, down to 101.4 by 6am, not breaking until 11am on 4-15-21. Bad headache/migraine. Nausea. Right eye became bloodshot. Hallucinations between 5-6am on 4-15-21. Injection site painful with burning sensation when pressure was applied.
35 2021-04-16 taste disorder, smell distorsion, taste impairment Metallic smells and tastes. Most foods have a sour metal taste or after taste. I did lose my smell... Read more
Metallic smells and tastes. Most foods have a sour metal taste or after taste. I did lose my smell when I had covid in December for many weeks but it had returned. I am now two weeks last my first dose of pfizer and am tasting metal in the back of my throat for the last 3 days.
35 2021-04-16 ringing in ears Onset of Tinnitus, ears ringing all the time, it?s especially noticeable in quiet environment.
35 2021-04-17 ear pain, ringing in ears Ringing, pain on left ear. Stared mild and progressively started to get worse to a point I could not... Read more
Ringing, pain on left ear. Stared mild and progressively started to get worse to a point I could not sleep without medication.
35 2021-04-17 lacrimation increased Chills; headakc; tiers; body acks; This is a spontaneous report received from a contactable consumer... Read more
Chills; headakc; tiers; body acks; This is a spontaneous report received from a contactable consumer. A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Em6203), via an unspecified route of administration on 27Mar2021 at 11:00 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Em6203), via an unspecified route of administration on 27Feb2021 at 11:00, both on left arm as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient was pregnant during time of vaccination. On 28Mar2021, the patient experienced Chills, headache, tiers, body aches. Outcome of events reported as recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.
35 2021-04-17 pain in jaw chills/ shivering and chattering teeth; shivering and chattering teeth to point where jaw hurt; seve... Read more
chills/ shivering and chattering teeth; shivering and chattering teeth to point where jaw hurt; severe headache; nausea; This is a spontaneous report received from a contactable consumer (patient). A 35-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: pfizerep7533) via an unspecified route of administration at right arm on 25Mar2021 at 10:30 (35-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history was reported as none. There were no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications (other medications) the patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: pfizeren6199) at left arm on 04Mar2021 at 19:45 (35-year-old at time of vaccination) at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in pharmacy or drug store. Patient experienced chills at 3 AM following the vaccine, shivering and chattering teeth to point where jaw hurt, severe headache and nausea (all from 26Mar2021 03:00) for four days following 2nd dose vaccine. Adverse events did not result in emergency room visit or physician office visit. Seriousness was reported as no. Since the vaccination, the patient has not been tested for COVID 19. No therapeutic measures were taken as a result of the event. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
35 2021-04-18 eye irritation, mouth swelling, mouth numbness, eye pain about 30 minutes after the vaccine I had burning eyes/stinging went away after 15 minutes. About 1.5... Read more
about 30 minutes after the vaccine I had burning eyes/stinging went away after 15 minutes. About 1.5 to 2 hours after the vaccine I started to feel like my lips, roof of my mouth, and cheeks were numb and tingling. It felt as though they were swollen, but my face was not swollen. It's almost the sensation that you get when you put orajel on and it begins to wear off. I took 2 Benadryl around 8pm because I felt like I was becoming more numb on my face. The next day I still had residual numb/heaviness feeling in my lips and tingling on my cheeks but not nearly as much as the previous day. All reactions were gone by the 36 hour marker.
35 2021-04-18 lip swelling Paralysis; Right lip swelling; This is spontaneous report from a contactable consumer (patient). A n... Read more
Paralysis; Right lip swelling; This is spontaneous report from a contactable consumer (patient). A non-pregnant 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 01Apr2021 at 05:15 PM (17:15), at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 04Mar2021 for COVID-19 immunization (left arm). The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a pharmacy or drug store facility. On 02Apr2021, the patient experienced right lip swelling and paralysis. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
35 2021-04-18 swelling of eyelid, bloodshot eyes On 4/12/2021, I began experiencing migraine-like symptoms: bad headache and irritated nerves at back... Read more
On 4/12/2021, I began experiencing migraine-like symptoms: bad headache and irritated nerves at back of neck. By 4/14/2021, I had a small sore at the corner of my left eye, which at the time I thought was an outbreak of herpes (which I also have, and have had near my eye before). However, the symptoms got worse. By 4/16/2021, I had a second sore appear near my cheekbone and intense itching on my face, with nerve pain in my face. By the morning of 4/17/2021, I woke up with my left eyelid swollen and redness in my left eye, which led me to seek medical attention at an urgent care facility. At urgent care, was diagnosed with shingles with concern of eye involvement. Was prescribed valcyclovir and an antibiotic eyedrop, ofloxacin. Follow up appointment with an opthamologist has been booked.
35 2021-04-18 tongue disorder, mouth numbness, mouth tingling Monday had Shortness of breath throat tightness about 20min after inj, tongue felt thick and body wa... Read more
Monday had Shortness of breath throat tightness about 20min after inj, tongue felt thick and body was itchy. 911 had to be called at pharmacy I was taken by ambulance to ER. I was given 2 Epi, 1 solumedrol, 1 albuterol treatment and 02. Then tuesday around 1300 I started to itch. I was driving to get medrol dose back. My became short of breath throat became tight, tongue numb and tingling. I had to call 911 and was taken by ambulance to ER. I was given 2 EPI, solumedrol, 02, 3 IV Benadryl. Thursday around 11am became itchy throat tight and shortness.of breath was driven to ER. I was given EPI, solumedrol, Benadry, and Pepcid. Labs were drawn, Xray, Ct, and ultrasound. I was admitted over night at a different local hospital and taken by ambulance. Monday still slightly itchy and muscular chest pain
35 2021-04-19 ear swelling, eye swelling, lip swelling First vaccine was administered on 3/27/2021 in my left arm lot # EP6955. I experienced a sore arm an... Read more
First vaccine was administered on 3/27/2021 in my left arm lot # EP6955. I experienced a sore arm and fatigue. On 4/4/2021 I began feeling ill with full body aches, fever (between 101-103), chills, sweating, sore throat, mild headache. On 4/5/2021 I wested tested for COVID 19, Flu A&B, and Strep throat. I tested positive for both Strep throat an COVID 19. I was given azithromycin for the strep and took Tylenol to lower the fever. My symptoms lasted till 4/8/2021. After that I was just very fatigued and nausea came and went. under the strong recommendation of my PCP, I then received my second dose of the Pfizer vaccine on 4/17/2021. Approximately 8 hours after the vaccine I suddenly felt ill. I was dizzy, nauseous and felt like I was going to faint. I experienced chills and was shaking uncontrollably for approximately 30 minutes. I vomited once, took Tylenol and went to bed. Throughout the night I felt mild chills, body aches and moderate nausea. I got up at 7am on 4/18/2021 with had a migraine headache (a sharp pain behind my life eye that went straight through to the base of my skull. I spent the day taking Tylenol and relaxing on the couch. At approximately 6pm I began itching. a few little dots showed up on my neck and leg. An hour later my legs, arms and neck had many very itchy red spots. I took a Benedryl and went to bed at 8pm. I woke up at 2am 4/19/2021 completely covered with itchy red spots (arms, legs, torso, neck, genitals, scalp, butt, face). I took more Benadryl and went back to sleep. The rash was extremely itchy and seemed to keep spreading. I went to my PCP at 8:45am and she prescribed Prednisone. Throughout the day the rash continued itch and my left eye, both ears, bottom lip, and knees began to swell. I spoke with a nurse over the phone who said to continue with the prednisone and Benadryl. On 4/20/2021, I woke up and the rash is not as pronounced or as itchy but still visible and still pretty itchy. Both my lips, left eye and both ears are still very swollen.
35 2021-04-20 ear infection, ear congestion, ear pain, ear swelling 1) 4/9- minor ear infection got a lot worse, got on antibiotics immediately on 4/9 (urgent care). 4... Read more
1) 4/9- minor ear infection got a lot worse, got on antibiotics immediately on 4/9 (urgent care). 4/9-4/11 ear infection continued to get worse even on antibiotics; 4/12 got on stronger antibiotics ciprofloxacin (urgent care) after ear turned purple, absessed swollen, shooting ear pain intermittent 6-7 on pain scale, crusty red started to block ear canal; 4/13-4/15 on stronger antibiotics, symptoms got better, got worse again 4/16- 4/18; 4/18 got on stronger antibiotics again- amoxocillin (urgent care); 4/19-4/20- developed Bells Palsy on left side of face (same side as ear infection and vaccine administered on left arm) diagnosed at ER on 4/20 for Bells Palsy. On steroids, antiviral and amoxocillin antibiotics and ear ointment still and hope Bells Palsy goes away and I recover TBD- today is 4/21/21.
35 2021-04-20 mouth tingling Tingling in left arm right above elbow and down through finger tips. Tingling in outside of left foo... Read more
Tingling in left arm right above elbow and down through finger tips. Tingling in outside of left foot/toes. Minimal tingling in left side of face/cheek/tongue.
35 2021-04-20 ringing in ears Tinnitus in left ear. Started very strongly the day after the second vaccination. Has continued fo... Read more
Tinnitus in left ear. Started very strongly the day after the second vaccination. Has continued for 1 week without relief.
35 2021-04-21 mouth pain Symptoms: itching, pain, red rash, fluid-filled blisters, fatigue, and orofacial pain. Treatment: Va... Read more
Symptoms: itching, pain, red rash, fluid-filled blisters, fatigue, and orofacial pain. Treatment: Valacyclovir HCL 1G tablet three times a day/7 days and gabapentin 100MG capsule 2 times a day and then 3 times at night Course: symptoms began on April 18, diagnosis received April 22 Outcome: still pending treatment
35 2021-04-21 smell distorsion Approximately 8 hours after vaccination, patient began to experience hallucinations while going to b... Read more
Approximately 8 hours after vaccination, patient began to experience hallucinations while going to bed. Sensed that she was sinking into her bed infinitely. Limbs were heavy/sore, felt she couldn't move. She is a marathon runner and her lower extremities were painful like she'd just run a race. After some hours was able to prop herself up. Was experiencing paranoia, like that the government was monitoring her. When she was able to get out of bed, had some minor visual hallucinations like thinking she spilled a bottle of medication that she had not. Felt she could "see" sounds as colors and shapes. No auditory hallucinations. Drifted in and out of sleep all night with strange dreams, and though the sheets were dry the next morning, there was a foul odor. Temp was normal in the AM when she first checked it. Had more mild paranoia about work throughout the next morning and felt back to normal by 4:30 PM (about 24 hours after vaccination), just a mild sore arm at that point. She used psilocybin once approx 20 years ago as a teen and states this felt similar. Has mild depression, well controlled, no other mental health issues, no other history of hallucination save with the remote psilocybin use, no current or recent illicit drug use.
35 2021-04-21 ringing in ears, ear pain Initially I had all the "usual" vaccine side effects for about 48 hours. But at the 72 hour mark I ... Read more
Initially I had all the "usual" vaccine side effects for about 48 hours. But at the 72 hour mark I experienced significant headaches, earaches, ringing in the ears, & dizziness that persisted non-stop until about 4/21/2021 (for 2 whole weeks). While these "extra" symptoms are not completely gone I am much better. Perhaps an inflammatory response of the immune system? There isn't a lot of information out on dizziness being a side effect & it's particularly scary when the headaches & the dizziness go on for 2 straight weeks (since most information out there states that side effects should go away within 3-4 days).
35 2021-04-21 ringing in ears Hello, I received my first dose of Pfizer Sunday morning and felt sick in the evening. Monday mornin... Read more
Hello, I received my first dose of Pfizer Sunday morning and felt sick in the evening. Monday morning I woke up and felt like I had the full on flu (light headedness, headache, ringing in ear, body aches) I took Tylenol to get through the work day. Yesterday morning I woke up with my left leg tingling, cooling sensation, numbing just like sciatica and later in the day I had really bad stomach pain radiating all around. I emailed my doctor my symptoms and she just informed me to keep monitoring my symptoms. Not sure if its all a coincidence but could this be related to my vaccine? It almost seems like the vaccine made my stomach and nerves inflamed? Today my left leg is fine with mild stomach pain.
35 2021-04-22 dry mouth, thirst, pain in jaw, mouth numbness, visual impairment, vision blurred Thursday 4/15/21 7pm: out of no where, marked increase in thirst/urination and dry mouth, tip of ton... Read more
Thursday 4/15/21 7pm: out of no where, marked increase in thirst/urination and dry mouth, tip of tongue numbing. Increased breathing/heart rate, random body chill and clammy handswith some tingling . Lasted ~1-2 hours. Friday 4/16/21: intermittent episodes of the same described above throughout day. Saturday 4/17/21: still experincing intermittent episodes, went to urgent care for exam as for 20 minutes hard to catch breath [was having anxiety at this point]. Calmed down and nothing foumd on exam. Sunday 4/18/21 still feeling off, but syptoms less intense. Monday 4/19/21 felt more normal, then had episode of vision spotting then complete blurriness in left eye for 10 minutes, followed by head pressure/headache for couple hours. Tuesday 4/20/21. Mild dry mouth all day and some jaw soreness in evening. Wednesday 4/21/21 felt normal all day. Thursday 4/22/21 sinus pressure for few hours/head congestion and dry mouth again. Today 4/23/21, still mild dry mouth.
35 2021-04-22 mouth numbness, feeling of choking "Pfizer-Bio-Tech COVID-19 Vaccine " Individual received the Pfizer Covid-19 vaccine. She began to f... Read more
"Pfizer-Bio-Tech COVID-19 Vaccine " Individual received the Pfizer Covid-19 vaccine. She began to feel throat tingling, lip numbness, and flush at 11:15 am. Patient denied SOB of breath, dizzy, and was swallowing well. Her vitals were 146/98,99, 20, 72, 90/% at 11:17 am. She was given Benadryl 50 mg IM in right Deltoid at 11:18 am. B/P 122/96,20, 88 P, 99 RA. 11:25 am. Individual reported the numbness and tingling has decrease. 11:30 am 128/82 99% RA 86,20. Individual stated that she no longer has any symptoms. 11:45 pm vitals 124/74, 20, 71, 99% RA no noted distress, flush feeling, tingling or numbness. 11:58 am 110/70, 99, 71, 18 Individual was escort to car with no noted distress and sent home with Additional information for Item 18: with family. .
35 2021-04-22 mouth tingling Patient received her dose around 5:10pm. She did not report any anaphylaxis or allergies prior to v... Read more
Patient received her dose around 5:10pm. She did not report any anaphylaxis or allergies prior to vaccination. She was monitored for 15 minutes and then left the facility. She had driven about 5-7 miles and then started to feel as if her throat was tightening/closing in. She stated that she could not swallow her saliva. She stated that her tongue felt tingly. She turned around in the car and returned to the facility. She arrived around1745. She was able to talk freely, although she stated that her voice was lower than normal. She did not exhibit any facial or neck swelling and did not have any rash to her trunk or to her injection site. She denied itching. Initial vital signs: BP 124/74, p-79, SaO2 99%. She stated that she was sensitive to Diphenhydramine and could not take that medication. During the next 5-10 minutes, her symptoms did not progress. She then revealed her history of CRPS/reflex sympathetic dystrophy. She stated that she had sensitivities to many medications, and that she just doesn't know until she tries one. She denies ever having anaphylaxis but states that she thinks she has come close to it a few times, but "rides it out". She also stated a history of asthma, and that how she was feeling was similar to how she feels after an asthma attack. Asked her if she had a rescue inhaler with her, but she stated that she did not. She was further observed, and at 1810 the left side of her throat was improving but the right side was still tight. Five minutes later, she stated that she was then able to swallow. By 1820, she stated that everything was improved. She felt well enough to return home. Another set of VS were taken: BP 110/60, P-68, SaO2 99%. She was instructed to let her husband drive her home and to follow up with her PCP regarding this episode and follow-up. She was additionally instructed that if her symptoms worsened, that she was to call 911. Also talked to her husband and instructed him regarding worsening of symptoms and follow-up. Called client today 4/23/21 at 11:30 and she reports that she did have a similar episode of the sensation like her throat was closing yesterday 4/22/21, but it resolved on its own without intervention. She also reported nausea and lightheadedness s/p vaccination. She states that she is feeling fine today.
35 2021-04-22 mouth tingling Tingling in back of mouth/tongue . No hives SOB or Facial swellimg
35 2021-04-22 swollen tongue Patient see in ED 4/22/2021 for evaluation of severe, constant throat swelling starting earlier toda... Read more
Patient see in ED 4/22/2021 for evaluation of severe, constant throat swelling starting earlier today after receiving her first COVID-19 vaccine. The patient was well until roughly ten to fifteen minutes after receiving her first dose of a COVID-19 vaccine at 1158. She gradually developed severe throat swelling, tongue swelling, and itching to her uvula and back of her throat, as well as a change in her voice. The patient was immediately given 0.5 IM epinephrine at the clinic and was given two dose of 25 mg benadryl en route by EMS. Symptoms improved after epinephrine and benadryl. Patient was discharged from ED against medical advice and returned to ED around 2100 for reported back of tongue swelling, swollen uvula, and "scratchy voice". Patient was then admitted to hospital for observation.
35 2021-04-22 visual impairment Patient received vaccine at 1031a, symptoms started at approx 1040am, started with visual disutrbanc... Read more
Patient received vaccine at 1031a, symptoms started at approx 1040am, started with visual disutrbances and dizziness, progressed to sweats, tachycardia, hypotension and nausea, suggested to patient to go to ER for further evaluation and patient agrees, medics called for EMS transport to ER
35 2021-04-23 mouth itchiness Patient developed hives, itchy mouth and throat developed about 10 minutes after receiving her secon... Read more
Patient developed hives, itchy mouth and throat developed about 10 minutes after receiving her second vaccine. benadryl 50mg IM was given at 11:42AM
35 2021-04-23 ringing in ears Approximately a week after getting the shot I started to experience tinnitus (pulsatile) in both ear... Read more
Approximately a week after getting the shot I started to experience tinnitus (pulsatile) in both ears.
35 2021-04-23 tongue disorder, tongue discolouration, swollen tongue, taste impairment I had a sore arm for a couple of days after the vaccine - at the site of injection. I was tired for ... Read more
I had a sore arm for a couple of days after the vaccine - at the site of injection. I was tired for a couple of days. Two days after the injection - I started experiencing a chalky layer on my tongue. I felt like my tongue was a little bit swollen slightly. Two days after that, I started having a sour taste and white bumps towards back of tongue. I showed my OB/GYN and she told me go to the my primary care doctor. My primary care provider wasn't sure what it was - could have been thrush - she put me on an anti-fungal mouthwash called Nystatin. I've been doing that - 5 ml rinse four times a day for seven to 14 days. The mouthwash isn't helping so I will be scheduling an appt with my PCP for next week. 1st Pregnancy
35 2021-04-24 eye swelling passed out; dizzy; nauseous; hit her head/huge bump on head; My left eye is half swollen shut; eyeli... Read more
passed out; dizzy; nauseous; hit her head/huge bump on head; My left eye is half swollen shut; eyelid and under eye are black; very swollen all over head and eye; in lots of pain; breastfeeding; breastfeeding; This is a spontaneous report received from a contactable consumer (who is also the patient). This consumer reported events for mother (self) and child. This is the maternal report. A 35-year-old female patient received the first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733), via an unspecified route of administration in the left arm, on 06Apr2021 12:15, as single dose, for COVID-19 immunisation, at a drug store. The patient medical history was not reported. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient had no prior COVID-19 and was not tested for COVID-19 post vaccination. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient did not received other vaccines in four weeks. On 07Apr2021 at 03:00, the patient went to the bathroom and felt fine. She sat on the toilet and all of a sudden felt dizzy and nauseous. Next thing she knew, she woke up on the floor and had a huge bump on her head near her left eye. She passed out and hit her head on the tile in the bathroom. Her left eye was half swollen shut, her eyelid and under eye were black, was very swollen all over her head and eye and was in lots of pain. She went to the emergency room around 04:30. All tests, CT scan and blood work came back normal. She was told that it was most likely caused by the vaccine. Treatment for the events included "CT scan, bloodwork, IV fluids" (as reported). She was hoping that Pfizer will pay for her ER visit since the events were vaccine reactions. She reported that she was still in lots of pain and was not taking pain meds because she was breastfeeding. The events resulted to emergency room and physician office visits. The outcome of pain was not recovered. The patient was recovering from the remaining events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442302 Baby case
35 2021-04-24 thirst low grade fevers; Severe allergic reaction; after she took the Tylenol and then the Advil, she felt ... Read more
low grade fevers; Severe allergic reaction; after she took the Tylenol and then the Advil, she felt drugged, like totally out of it; so tired she couldn't move; getting really winded; for the 4-5 days after receiving her Covid 19 vaccine she would wake up at that same time around 1:30AM since it started on 20Mar2021; extremely thirsty; Even going to the bathroom or getting up from the couch her heartrate would go up to the 120-130s; Her heart was doing lots of rapid jumps; Her heart was doing lots of rapid jumps; her heart was racing; SOB and Dates for getting really winded; This is a spontaneous report from a contactable consumer A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: ER2613), via an unspecified route of administration on 19Mar2021 (at the age of 35-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included mixed connective tissue disease diagnosed in 2019, autoimmune disorder and anxiety from unknown dates and unknown if ongoing. Concomitant medication included diazepam (VALIUM) taken for anxiety, start and stop date were not reported; paracetamol (TYLENOL A) taken for an unspecified indication, start and stop date were not reported; ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported. The patient experienced her heart was doing lots of rapid jumps (arrhythmia) on 20Mar2021 with outcome of not recovered sob and dates for getting really winded (dyspnoea) on Mar2021 with outcome of recovering, her heart was racing on 20Mar2021 with outcome of not recovered, getting really winded on 22Mar2021 with outcome of recovering, for the 4-5 days after receiving her covid 19 vaccine she would wake up at that same time around 1:30am since it started on 20mar2021 with outcome of unknown, extremely thirsty on 20Mar2021 with outcome of unknown, low grade fevers on an unspecified date with outcome of unknown, severe allergic reaction on an unspecified date with outcome of unknown, even going to the bathroom or getting up from the couch her heartrate would go up to the 120-130s on 20Mar2021 with outcome of not recovered. Additional details were provided as: "I started having a reaction within 12 hours of the shot that persisted. Four (4) days after I was at urgent care and was sent to see a cardiologist due to SOB and heart rate jumps that were happening." In the past two weeks the patient has seen the cardiologist, had ekgs and echos completed and and now is being sent to see an electrophysiologist. The cardiologist wants her to postpone the second dose until she sees the electrophysiologist since he doesn't know if this is exacerbation of something or was caused by the vaccine. She had her first dose on 19Mar2021 around 12:45PM-1:00PM in the afternoon. After her vaccine she was ok. She had actually taken a Valium before she went to get the Covid 19 vaccine because she was nervous. She doesn't know if taking the Valium before getting the Covid 19 vaccine had anything to do with her delayed reaction. She does not take the Valium every day. She woke up around 1:30AM Saturday morning, 20Mar2021 and her heart was racing. Her mother is a nurse and her mother came over the next day to monitor her. Her heart was doing lots of rapid jumps. Even going to the bathroom or getting up from the couch her heartrate would go up to the 120-130s. (beats per minute) She and her mother monitored her heart for a while and she called the clinic where she received the Covid 19 vaccine and the nurse told her to go to an Urgent Care. She does report she has an autoimmune disease and she was wondering if she was having a flare up that the Covid 19 vaccine had caused. She could not find a doctor to talk to her about it. Even her primary care doctor wouldn't help her. Everyone told her to go to an Urgent Care or the emergency room. On Monday, 22Mar2021, she tried to get up and move around but she was getting really winded. She was trying to do things she normally does like walking in her backyard or walking down the hallway. On Tuesday, 23Mar2021 she went to the urgent care. The urgent care did an EKG and told her she needed to see a cardiologist. She was able to see a cardiologist the next day on Tuesday, 24Mar2021. The cardiologist had her wear a Holter monitor to monitor her heart rate for 24 hours. The results showed that she was having arrhythmias, heart rate jumps. The cardiologist did more EKG's and an echocardiogram. The cardiologist wants her to see an electrophysiologist because of what he saw on the Holter monitor. She is asking if it's possible that she had a heart issue before and the Covid 19 vaccine brought it to the surface. She's read things online where people have had similar symptoms. Is it a side effect? She would also like to report that for the 4-5 days after receiving her Covid 19 vaccine she would wake up at that same time around 1:30AM since it started on 20Mar2021. She's unsure if she should get the second Covid 19 vaccine. Her second appointment is scheduled for this Friday, 09Apr2021. When she woke up that morning of 20Mar2021 she was extremely thirsty. She reports she does not drink alcohol because of her autoimmune disease, but the thirst she experienced felt like she had been drinking alcohol and was experiencing the extreme thirst that comes with a hangover. The first 5 days after receiving the Covid 19 vaccine were the worst and that's why she decided to go to the urgent care. Her heartrate hasn't improved. Her windedness had improved by the tenth or eleventh day. She can go on a walk and jump up and down with her daughter now. The windedness is lingering a little but is definitely improved. Her autoimmune disease is called Mixed Connective Tissue. She takes no medications for it. She manages it with her diet. Her mother had called her rheumatologist on call on Monday night, 22Mar2021 and asked him is there anything the caller can do or anything she can take. The rheumatologist on call told her to take Aleve. She didn't take Aleve but she did take Tylenol and then hours later she took Advil. She does normally run low grade fevers with her autoimmune disease. The fevers are never high, usually around 99.8F never going over 100F. The low grade fevers have been occurring prior to the Covid 19 vaccine for years. She reports that after she took the Tylenol (Tylenol Extra Strength 500mg, she took 2 tablets) and then the Advil (Advil 200mg, she took 1 tablet), she felt drugged, like totally out of it. So tired she couldn't move. And she's taken those medications before and never felt like that. The patient underwent lab tests and procedures which included electrocardiogram: arrhythmias, heart rate jumps on 23Mar2021. No follow-up attempts are possible; no further information expected.
35 2021-04-25 loss of taste, loss of smell Received COVID Pfizer vaccines on 1/25/2021 and 1/3/2021. On 4/22/2021 developed headache, loss o... Read more
Received COVID Pfizer vaccines on 1/25/2021 and 1/3/2021. On 4/22/2021 developed headache, loss of taste/smell, nasal congestion. COIVD-19 test positive.
35 2021-04-25 smell distorsion, taste disorder Tachycardia (130-140s), palpitations, chest pain, breathlessness - now on week 3 of symptoms. Await... Read more
Tachycardia (130-140s), palpitations, chest pain, breathlessness - now on week 3 of symptoms. Awaiting a Cardiology appointment. Also with worsening smell and taste compared to prior to vaccination. Now with paranosmia.
35 2021-04-25 swollen tongue I had a severe reation to my first dose which required Benadryl and medics to evaluate me so I took ... Read more
I had a severe reation to my first dose which required Benadryl and medics to evaluate me so I took 50 mg 30 min prior this 2nd dose. I recieved my injection around 5:00 pm and was placed under observation to monitor for reaction. Within 7 minutes I had a rash on my chest, arms and neck. I was taken to an observation room accompanied by my mother who had my epi pen. Withing 1 minute of moving to the room my tongue began to swell. I gave the nurse permisoon to inject me in my left thigh with a syringe of epinephine from the clinic's suppy. 911 was called and I was transported to the Hospital where I recieved a pepcid injection, zofran for extreme nausea from the epinephrine and underwent observation for 2.5 hours. I was release 4/23/2021 and wass prescribed prednisone 20 mg 3xs daily for 5 days to help calm my reaction. I was told at the hospital that my throat was also very red upon arrival.
35 2021-04-26 blindness in both eyes I woke up with neck pain on the right side of the back of my neck on Sat 4/24. Thinking I just "slep... Read more
I woke up with neck pain on the right side of the back of my neck on Sat 4/24. Thinking I just "slept wrong", I ignored this symptom initially. Over the course of Sunday and Monday, this neck pain worsened culminating in severe pain by Monday afternoon with significant decreased ROM (inability to turn my head from side). At approx 1800, while inactive and sitting, I lost vision in my left eye. Since I am fairly recently post partum (delivered 3/20/21), I took my blood pressure as a precaution. My initial reading was 161/108 with repeat 5min later 156/106. I was instructed to go to the nearest ER. My BPs there were 171/86 and 166/96. Labs and diagnostic imaging were performed and I rec'd IV fluids, Reglan, and IV Tylenol. I was discharged around 0045 with a diagnosis of Migraine Headache. I woke up on Tuesday 4/27 with a worsening headache. My BP was 148/91, 141/100 and 130/100 throughout the morning. I was seen by my chiropractor in an attempt to resolve the neck pain around noon, my BP afterwards was 149/99 142/97-No resolution of headache. At this point I was instructed to go to Medical Facility for further testing and admission to the women?s services unit. My BP just prior to admission was 146/107. I was admitted, given an IV infusion of magnesium sulfate and am currently inpatient with plans to be discharged tomorrow.
35 2021-04-26 extreme sound sensitivity I received my first shot at 4:15PM on Sunday 04/25/21. The dose was administered into my right arm. ... Read more
I received my first shot at 4:15PM on Sunday 04/25/21. The dose was administered into my right arm. Within 30sec-1min I started feeling pressure wave slowly spreading from my right arm and traveling to my right shoulder blade and neck. Within few minutes I developed neck pain like I pulled a muscle on my right side. 1-2min later I started having muted hearing in my right ear and felt heaviness on my head. within 10-20mins my left ear was impacted as well. (hearing issues lasted about 30mins-1hr). Also, within first 10-15 minutes my face felt swollen and heavy, but it was not visually swollen. Once I took my mask off in the car, I had red/pink marbled rash on my skin on the area that the mask was covering. I haven't had any face rash from this mask before. I asked the vaccine site staff if the back and neck symptoms are normal, she gave me a blank stare and nodded her head. Additionally, after first 10 minutes my left thigh muscle started cramping and involuntarily moving for a few minutes, quickly followed by feeling of pulling nerve in my right thigh. That lasted around a minute and suddenly moved upwards and hit my back with sharp pain like radiculitis. Every slight change of move felt like sharp sting. I was still in the recovery area, but I had trouble staying in the sitting position. We went home and back pain developed into crippling pain within 30 mins-1hr after the shot. I could do less and less. By 1 hr I was only able to lay flat in my bed, unable to sit. Bending over would not be possible because of tightness and sharp pain. I spent the next day in bed and barely tiptoed to the bathroom when needed, holding onto the furniture and walls. It has been more than 48 hours and I still can't bend or wash my hands. I can wash one at a time. Today I can sit, so my back improved since yesterday, but my moves are limited and I feel some pain in my back when I walk. I can't sit for too long and sitting down or getting up hurts.
35 2021-04-27 eye twitching blepharospasm in left eye
35 2021-04-27 taste impairment injection site soreness lasting aproximately 24 hours, diarrhea lasting about 48 hours, metalic tast... Read more
injection site soreness lasting aproximately 24 hours, diarrhea lasting about 48 hours, metalic taste in mouth lasting about 24 hours
35 2021-04-27 eye discomfort Eye twitching/spasm
35 2021-04-27 vision blurred Nearly fainting; vertigo like symptoms; lightheaded; lethargic; blurred vision; shaky; heart palpita... Read more
Nearly fainting; vertigo like symptoms; lightheaded; lethargic; blurred vision; shaky; heart palpitations; limbs feel heavy; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ep 6955) via an unspecified route of administration, administered on the right arm on 26Mar2021 15:30 at a single dose for COVID-19 immunization. Medical history included anxiety, depression; and known allergies: penicillin and gluten. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and sertraline hydrochloride (ZOLOFT). The patient previously took amoxicillin and diflucan and experienced allergies. On 30Mar2021 22:00, the patient experienced nearly fainting, vertigo like symptoms, lightheaded, lethargic, blurred vision, shaky, heart palpitations and limbs feel heavy. The event resulted to a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the events for 1 day. Treatment was received for the events which included medication, heart monitor, MRI, MRA, MRV, CT scan. COVID test post vaccination included nasal swab on 01Apr2021: negative. Patient was not pregnant. The facility where the vaccine was administered was in a school or student health clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
35 2021-04-28 ear pain Fever, chills, pain at injection site, tired, nausea, tightness of throat, ear pain
35 2021-04-28 ringing in ears Tinnitus in both ears
35 2021-04-28 ringing in ears I started experiencing a humming/vibrating sensation in my right ear 2 days post vaccine (4/24). I ... Read more
I started experiencing a humming/vibrating sensation in my right ear 2 days post vaccine (4/24). I saw an ENT on 4/28 and everything looked normal. Diagnosed with tinnitus and still experiencing it.
35 2021-04-29 loss of taste, loss of smell New loss of taste or smell Congestion or running nose
35 2021-04-29 eye movement disorder The patient was vaccinated at approximately 0906 am, was walking out of the gym when a nurse noticed... Read more
The patient was vaccinated at approximately 0906 am, was walking out of the gym when a nurse noticed that she appeared to be unstable. The nurse got behind immediately before the began to fall to the ground, and she eased the patient to the ground so that she did not hit her head. After falling she was observed to lose consciousness and have rapid eye movement which appeared to be seizure like activity. After about two minutes she began to have more pronounced arm/leg movement that resembled seizure like activity. Staff attempted to arouse patient but she was not awake until 5 minutes after the seizure like activity. EMS was called at the 3 minute mark, about 0910am. Upon awakening, patient was lethargic, but able to identify herself and that she had a history of a seizure disorder, and took Keppra this morning. After regaining consciousness she again began to have seizure like activity and appeared to go in and out of consciousness. Medics arrived at 920 am and patient was transported to hospital. Husband was contacted via the patients cell phone and informed of the event.
35 2021-04-30 mouth numbness, taste impairment, mouth tingling Metallic taste in mouth - like having pennies on my tongue. Occasional Tingle/numbness of lips
35 2021-04-30 eye discomfort brain felt like it wasn't working; Dizziness; mental fog; exhaustion; weak; shaky; upper back neck s... Read more
brain felt like it wasn't working; Dizziness; mental fog; exhaustion; weak; shaky; upper back neck shoulders and head all hurt; neck shoulders and head all hurt; neck shoulders and head all hurt; neck shoulders and head all hurt; Non-stop pressure behind her neck, forehead, eyes; Injection site arm throbbing really bad; This is a spontaneous report from a contactable patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 10:15 (Batch/Lot number was not reported), at the age of 35-years-old as a single dose for COVID-19 immunization. The patient is not pregnant. Medical history included poly cystic ovary syndrome. The patient had no known allergies. Concomitant medication included ethinylestradiol, etynodiol diacetate (KELNOR) for birth control; metformin; ascorbic acid, betacarotene, biotin, capsicum annuum fruit, colecalciferol, collagen marine, curcuma longa, cysteine hydrochloride, equisetum arvense, fallopia japonica, hyaluronic acid, iodine, keratin, lysine, methionine, piper nigrum, selenium, serenoa repens, tocotrienols nos, withania somnifera, zinc (NUTRAFOL); all start and stop date were not reported. The patient had side effects which started within 45 minutes (also reported as within 30 minutes) of injection. Dizziness, mental fog, she felt like she was looking in through someone else's body. She doesn't know how she drove home from appointment. Her brain felt like it wasn't working, chronic exhaustion, weak, shaky, upper back neck shoulders and head all hurt severely. Non-stop pressure behind her neck, forehead, eyes with headache. Injection site arm was throbbing really bad at night. Symptoms lasted 8 days. The events occurred on 26Mar2021 11:00. No treatment was received. The patient had no other vaccine in four weeks. The patient had no prior vaccination and was not tested for COVID post vaccination. The outcome of the events was recovered with sequel. Information on the lot/batch number has been requested.
35 2021-04-30 ringing in ears Tinnitus for a day.
35 2021-05-01 lip swelling, eye pain A portion of my bottom lip has lost it?s color. I woke up the next day after my shot and saw that th... Read more
A portion of my bottom lip has lost it?s color. I woke up the next day after my shot and saw that this part of my lip was extremely light pink and a little raised like it is swollen. I also have been experiencing eye pain.
35 2021-05-01 mouth tingling About 5 minutes after my shot my throat started feeling warm and swollen. About 20 minutes later I h... Read more
About 5 minutes after my shot my throat started feeling warm and swollen. About 20 minutes later I had some tingling in my lips and tongue
35 2021-05-02 deafness Temporary hearing loss, severe back pain and tingling in legs off and on persisting for more than a ... Read more
Temporary hearing loss, severe back pain and tingling in legs off and on persisting for more than a week.
35 2021-05-03 loss of smell Sore throat, cough, body aches, congestion, loss of smell, headache and trouble sleeping.
35 2021-05-04 light flashes or floaters in the eye Latent hives; flashing; vertigo; This is a spontaneous report from a non-contactable Other HCP. This... Read more
Latent hives; flashing; vertigo; This is a spontaneous report from a non-contactable Other HCP. This 35-year-old non-pregnant female Other HCP reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on left arm on 27Jan2021 12:00 PM at single dose for COVID-19 Immunization. The patient's medical history and Concomitant medication were not reported. Historical vaccine included first dose of COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. On 29Jan2021, the patient experienced Latent hives, flashing, vertigo. The patient did not receive any treatment but resulted in doctor or other healthcare professional office/clinic visit. The outcome for the event was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
35 2021-05-05 lip swelling, lip itchiness Client vaccinated today at 1200. Started having itchy and swelling lips. Client denied any tongue or... Read more
Client vaccinated today at 1200. Started having itchy and swelling lips. Client denied any tongue or throat itchiness or swelling. Client has hx of Bee and wasp anaphylaxis. BP 110/82, HR 96, O2sat 98%. Epi was not given as the swelling and itchiness did not worsen. Pt reported improvement at 1238. Client's provider called recommended client be monitored for 2 hours. Client stayed until 1320, stated she is not staying any longer and she is driving herself to work at a healthcare facility. Client left.
35 2021-05-06 lip blister Blisters on lips, mildly elevated heart rate/palpitition
35 2021-05-07 taste impairment, smell distorsion Vertigo, taste metal, smell ammonia at random, body aches, nausea, lungs feel sticky even though my ... Read more
Vertigo, taste metal, smell ammonia at random, body aches, nausea, lungs feel sticky even though my O2 level is good, feel like I need to sneeze but can?t for days (which is not normal for me) I feel fevered but my thermometer says I?m normal. Extreme fatigue for days. I?m sleeping 12 hours a day.
35 2021-05-07 taste impairment, thirst Injection day: several hours after injection: Pain at injection site radiating up into shoulder Extr... Read more
Injection day: several hours after injection: Pain at injection site radiating up into shoulder Extreme fatigue to the point of not being able to function Headache Took Tylenol 1000 mg went to sleep at 8 pm Day 1 after injection: Arm sore Woke with headache and nausea Woke to metallic salty taste in mouth/throat (almost like swallowing sea water) Persistent cough (like throat tickle) Took Tylenol Cold Fatigued despite sleeping nearly 10 hours night prior All food and drink tastes metallic/salty Headache continues to worsen Took Aleve/Tylenol combination pill Body aches Day 2 after injection: Woke with headache and nausea Metallic/Salty taste worsened over night Cough worsened Stiffness/Sore at injection site, neck and shoulder pain spanning across upper back Extreme fatigue Extreme thirst (does not take away metal/saltwater taste in mouth) Will continue to monitor and take over the counter pain relief unless symptoms worsen
35 2021-05-08 hearing loss Starting about 10 days after my second dose, I had a persistent dizziness and headache along with fo... Read more
Starting about 10 days after my second dose, I had a persistent dizziness and headache along with food aversions for approximately 10 days and weren?t helped by OTC medicines, rest, hydration etc. On or around day 8 I also lost the partial hearing in one of my ears.
35 2021-05-08 lip swelling Skin itch, swollen face and lips, hives
35 2021-05-08 bloodshot eyes, eye pain my right eye hurt and red and it hurt to open it
35 2021-05-09 mouth numbness On 5/10/21 the patient received her second vaccine. After receiving the second dose the patient rep... Read more
On 5/10/21 the patient received her second vaccine. After receiving the second dose the patient reported that her face and lip felt numb. After 15 minutes the patient reported that she was felling better. While driving home the patient stated that her throat started to close and it throat was itchy. The patient drove to the ER were she recieved epinephrine. The patient was later trasported the Hospital were is still receiving treatment. The patient reported that she is feeling better.
35 2021-05-09 vision blurred Swelling of throat, dizziness, confusion, light headed, blurry vision, rash & hives around neck and... Read more
Swelling of throat, dizziness, confusion, light headed, blurry vision, rash & hives around neck and cheeks. Itchiness and hot feeling around neck and face.
35 2021-05-10 loss of taste, loss of smell On 5/6/2021, developed chills, body aches, headache, loss of taste/smell, congestion and sore throat... Read more
On 5/6/2021, developed chills, body aches, headache, loss of taste/smell, congestion and sore throat. Tested positive for COVID-19 despite history of 2 vaccine doses.
35 2021-05-10 ringing in ears I never had tinnitus (ringing in ear) before in my life and there's never been any issue with my ear... Read more
I never had tinnitus (ringing in ear) before in my life and there's never been any issue with my ears neither. 1 day post dose 1, I started to hear intermittent sounds like ringing and cricket in my right ear. about 2 weeks after that, the ringing started full force 24/7... Still am hearing the ringing as of now, it's been almost three weeks...
35 2021-05-10 tongue blistering, mouth discomfort Fever; Body Ache; Chills; Malaise; Pain and swelling on my supraclavicular lymph node on left side; ... Read more
Fever; Body Ache; Chills; Malaise; Pain and swelling on my supraclavicular lymph node on left side; supraclavicular lymph nodes sit in your clavicle/lymph node were swollen; Discomfort; Skin of the mouth and the tongue feel like on fire; tongue and inner mucosa; Tongue has some spotting on it, on the side of it; This is a spontaneous report from a contactable other patient. A 35-year-old female received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: EW0162 and expiry date was not provided), via an unspecified route of administration in left upper arm, on 20Apr2021 at 13:30 (at the age of 35-years-old) as a single dose for covid-19 immunisation. Medical history included hernia, anxiety, depression, GERD (gastrooesophageal reflux disease) and acid reflux. Concomitant medications included 150mg modafinil for visuals, daily (take when on work, on shifts) and 150mg bupropion hydrochloride (WELLBUTRIN), daily. Patient received first dose of covid-19 vaccine on 20Mar2021. On 20Apr2021 at 19:00, patient state that just inside of her mouth started feel like the skin of the mouth and the tongue feel like on fire, feel like almost had eaten something like spicy or if have drink hot cup of coffee have that feeling in tongue and inner mucosa and started feeling that tongue has some spotting on the side of it. On 21Apr2021 at 06:30, patient had a fever, body ache, chills malaise and then have pain and swelling in supraclavicular lymph node on left side, had pain where supraclavicular lymph node site and swelling at that site and lymph node were swollen. As reported, not the injection site where the supraclavicular lymph nodes site in clavicle that was where the discomfort was. The events relatedness to covid 19 vaccine was related. Reporter's concern was just want to report the side effect after receiving the COVID 19 vaccine. Reporter seriousness for all events was unspecified. The outcome of events was unknown. Causality: Nurse stated, Yes. All we can say is it started after vaccine administration. No follow-up attempts are needed. No further information is expected.
35 2021-05-12 eye twitching Fever, extreme fatigue, pain (all that lasted for about a week) but the day after the shot I had a s... Read more
Fever, extreme fatigue, pain (all that lasted for about a week) but the day after the shot I had a seizure. And within the next day or so I started having problems with the right side of my face being numb/heavy. My right eye twitching sometimes. And it being difficult to lift that side of my face (eyebrow and mouth) and sometimes it?s impossible.
35 2021-05-12 lip swelling Pt came in for her first dose of the Pfizer vaccine. She told her vaccinator that she was allergic t... Read more
Pt came in for her first dose of the Pfizer vaccine. She told her vaccinator that she was allergic to bees and penicillin, she was instructed to wait for 30 minutes after her shot instead of 15 minutes. As she waited in the Waiting room, the volunteer noticed that she was itching and approached her to see if she was okay. She said that the pt removed her mask and her lips were swollen and she began holding her throat while wheezing "allergic". The volunteer notified the RN who came to the pts side. The patient gave herself her own EpiPen and later our RN administered a second dose. O2 was started and 911 was called. She lost consciousness and we placed her on the ground and began manual breathing treatments until the fire dept arrived. They began to administer medicine until the EMT arrived and took her to the hospital.
35 2021-05-13 dry mouth, lip swelling its kind of scratchy and red in rays its kind of itches; its kind of scratchy and red in rays its ki... Read more
its kind of scratchy and red in rays its kind of itches; its kind of scratchy and red in rays its kind of itches; its kind of scratchy and red in rays its kind of itches; lip swelled up on left side; really tired; Dry mouth; soreness at injection site; still had not had periods/ had not yet started her cycle; anaphylactic reaction; rash so it is on her left armpit kind of going towards her chest; swelling; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8736), via unspecified route of administration in left arm on 24Apr2021 at single dose for COVID-19 immunisation. The relevant medical history included react like that normally is it eat bananas or sweet potato, asthmatic. Concomitant medications included vitamins nos. The patient previously took Wellbutrin, Methocarbamol and both experienced drug allergy. The patient previously received first dose of BNT162B2 (Lot number: ER8735) on 02Apr2021 at the age of 35 years old for COVID-19 immunisation and had menstruation irregular. The patient got her 2nd Vaccine that past Saturday and she got it on her left side of her body and her lip swelled up on left side and then she got a rash but the rash was going away and swelling going down but she thought she needed to report that. The patient still had not had periods which was very unusual for her and she tested the pregnancy test and she was not pregnant. Anatomical site of swelling was stated as left side of her lip on her face it looked like she got stung by a bee and then the swelling had been going down on that, the rash was going away as well. When confirmed the event start date, 25Apr2021 was stated for the swelling and rash. For causality the patient stated that she thought so because she was allergic and she avoided she had not got a rash like that from eating them. She also got like swelled lips or hives and she did not get hives and in this period that was the only thing and she had couple of other friends that had biological symptoms too, so that was the reason she was pretty sure it was connected. The patient stated that the swelling and the rash was still there, the swollen lip was going down and she had not yet started her cycle. She also stated that swelling was improved, rash was better but she could still see it. After her vaccine she was really tired and she was sure a lot of people were so she just fall asleep for 12 hours. When she woke up it was a little better. So she did not take anything specifically for that. When described the signs and symptoms of the anaphylactic reaction, the patient stated that it looked kind of well she mean let her look at the rash so its on her left armpit kind of going towards her chest and its kind of scratchy and red in rays its kind of itches over then but its not writhing or sheathing. She was asleep for 12hrs she thought it came up some time either late Saturday night or early Sunday morning. She didn't had any problem in breathing, she didn't have tightness in her chest no racing heartrate nothing like that. No medical intervention required. No Emergency Department and no hospitalization. The patient got dry mouth but again she didn't like super weird, she didn't had any racing heart rate, she did not had any respiratory symptoms, obviously dermatologically did. She would say as reaction go well significantly minor she had soreness at injection site but she didn't had any raised she wasn't raised can't even tell now for that well that fine. No initiation of new medication or other treatment or procedure required. Her husband was positive back in the fall. She was tested but she quarantined from him and she never got it. She tested 4 times negative. The outcome of the event rash, lip swelling and swelling was recovering, while other events were unknown.
35 2021-05-13 lip swelling At midnight, 9 hours after dose, lips started swelling. Got progressively worse for 3 hours. Disappe... Read more
At midnight, 9 hours after dose, lips started swelling. Got progressively worse for 3 hours. Disappeared after 24 hours.
35 2021-05-13 bloodshot eyes Irregular period starting 05/12/2021 with heavy bleeding, diarrhea and blood shot eyes
35 2021-05-13 vision blurred blurred vision- intermittent Lower extremity edema- bilateral
35 2021-05-14 taste impairment Dysgeusia/Copper taste in my mouth; sore arm; inflamed gums around teeth; hair follicles on scalp we... Read more
Dysgeusia/Copper taste in my mouth; sore arm; inflamed gums around teeth; hair follicles on scalp were sore to touch/movement of hair; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Jan2021 (at the age of 35 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Recurrent pregnancy loss. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); ubiquinol (UBIQUINOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No Allergies to medications, food, or other products. Since 26Jan2021, the patient experienced sore arm, hair follicles on scalp were sore to touch/movement of hair, inflamed gums around teeth. About 72-96 hrs after inoculation, on 28Jan2021, she started having severe Dysgeusia. There was a copper taste in her mouth that won't go away. No treatment received for the adverse events. Outcome of the event dysgeusia/copper taste in my mouth was not recovered and other events was recovered. Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
35 2021-05-14 eye irritation Patient reports burning sensation in bilateral eyes. No pruritus or blurry vision. No shortness of... Read more
Patient reports burning sensation in bilateral eyes. No pruritus or blurry vision. No shortness of breath or difficulty in breathing. Patient reported improvement in symptoms after few minutes. She was educated to notify medical staff of any worsening symptoms. patient left site well.
35 2021-05-14 mouth tingling Tingling of checks and lips.
35 2021-05-16 double vision Projectile vomiting; patient has no memory of ever vomiting in past 15 years Significant double visi... Read more
Projectile vomiting; patient has no memory of ever vomiting in past 15 years Significant double vision rendering patient unable to walk without assistance Trouble balancing when standing still and had a minor slip down some steps Slurred/incoherent speech Headache (less severe than other symptoms) Fatigue lingering 48 hours
35 2021-05-16 burning mouth syndrome, swollen tongue PATIENT DESCRIBED IT AS A SWOLLEN TONGUE THAT FEELS AS IF SHE BURNT IT. ULCERS ON TONGUE WITH SORENE... Read more
PATIENT DESCRIBED IT AS A SWOLLEN TONGUE THAT FEELS AS IF SHE BURNT IT. ULCERS ON TONGUE WITH SORENESS. SYMPTOMS WERE NOTICED 24 HOURS AFTER VACCINATION, BUT WORSENED ON DAY 5.
35 2021-05-17 sensitivity to light, taste impairment started at 3 am 4/8/2021- stuperous, mind fog, forgetfulness, inability to walk, joint pain, letharg... Read more
started at 3 am 4/8/2021- stuperous, mind fog, forgetfulness, inability to walk, joint pain, lethargic, metal taste in my mouth, sensitivity to light, intense brain pressure like a migraine but not this lasted 3 days.
35 2021-05-17 ringing in ears Tinnitus in both ears - began 3 days after first dose, persistent 24/7 Heavier menstrual flow and i... Read more
Tinnitus in both ears - began 3 days after first dose, persistent 24/7 Heavier menstrual flow and increased cycle duration
35 2021-05-19 hearing loss, ear swelling, ear discomfort entire intestines hurt her; back pain/sharp pain in the lower back; Back pain felt like nerve inflam... Read more
entire intestines hurt her; back pain/sharp pain in the lower back; Back pain felt like nerve inflammation like sciatica; Back pain felt like nerve inflammation like sciatica; sore pain in the spine area/pain can change from day to day; it can be on both sides of spine, or tailbone; right side neck pain (felt like a pulled muscle); sharp shoulder blade pain/shooting pain in the hips when she walks; right ear, it felt swollen; hearing was muted- approximately 20% hearing loss, could not hear clear sounds/partial hearing loss/ dulled, similar to wearing a thick hat/transferred to her other ear; Feeling like a pressure on her ear; little pinkish rash/pinkish marbled rash; felt woozy; felt a little drunk or funny; felt a little drunk or funny; She currently has these symptoms, limited movement; difficulty walking, can't walk fast; felt like body could not hold her weight anymore; She can't bend over without pain and is unable to get things on the bottom of the refrigerator or pots in the kitchen; jerking muscle in the left thigh and right thigh; felt a heaviness on her face, felt like a heavy mask on it even when the mask was removed; Pain is a stabbing pain very painful and then the stabbing pains come and go and feels like a pulling pain, like a nerve pain; numbness in buttocks and central part of buttocks like tingling pins and pricks; numbness in buttocks and central part of buttocks like tingling pins and pricks/tingling sensation in both hands and both feet; pain in buttocks; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 25Apr2021 at 16:15 (at the age of 35 years old) (Lot Number: EW0176, unknown expiration) as 1st dose, single for COVID-19 immunization. Medical history included ongoing penicilline allergy since at the age of 17 years old (manifested by breathing issues, tightness in neck, all swollen up) and currently the patient does not have a thyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL), both ongoing as the patient does not have a thyroid. The patient previously took codeine and experienced allergy (at the age of 17 years old). A few minutes after receiving the vaccine on 25Apr2021, the patient experienced right side neck pain (felt like a pulled muscle) and sharp shoulder blade pain. She got the vaccine in her right arm but had no arm pain. Then in her right ear, it felt swollen and her hearing was muted- approximately 20% hearing loss, could not hear clear sounds. Feeling like a pressure on her ear with partial hearing loss. It was dulled, similar to wearing a thick hat. Then it transferred to her other ear. Her face was feeling swollen, but it was not swollen, and she had a little pinkish rash but just under her mask. She didn't have any breathing problems. She asked the (name) staff member if these symptoms were normal. Patient was sitting in the waiting area of (name) pharmacy after administered the COVID-19 vaccine; all of these symptoms started happening around 3-4 minutes after receiving the vaccine. She would say within first 15 minutes after the COVID-19 vaccine was administered, it affected her other ear, where both ears had the muted hearing sensation which lasted about 2 hours. These side effects lasted about 1-2 hours and resolved on their own, no ointments were used. About 15 minutes after receiving the vaccine, she started having back pain, felt woozy, and felt a little drunk or funny. About 45 minutes later, she had sharp pain in the lower back, shooting pain in the hips when she walks. She currently has these symptoms, limited movement, difficulty walking, can't walk fast. After that, she was in bed all day and could barely make it to the bathroom. She previously was very healthy and regularly took long walks. Her back and hips feel sore. Back pain felt like nerve inflammation like sciatica where she got sharp pain in her lower back that felt like immediate inflammation. She got to the point where she was not able to sit straight, felt like body could not hold her weight anymore. She can't bend over without pain and is unable to get things on the bottom of the refrigerator or pots in the kitchen. She is unable to wash her hands together, she felt like her back can't support her weight. She had to wash one hand at a time. She is unable to get out of bed regularly, she has to roll out of bed. It has been 9 days from the vaccine and is still having shooting pains in her hips and jerking muscle in the left thigh and right thigh and it felt like nerves pulling string in the right leg which lasted only like 30-45 seconds. Before she went to the (name) pharmacy for the COVID-19 vaccine, she had never had any sorts of back issues, no strain, no health problems in that area. She told her husband she was going to have to lay on the ground or go home, so they left. She can't walk more than 10-15 minutes. She left the pharmacy, and when she got in the car about 20 minutes after she had gotten the vaccine, she felt a heaviness on her face, felt like a heavy mask on it even when the mask was removed. She felt initially that her face was swollen, like it was pressed, but there was no visual swelling that she could see in the mirror. When she took her mask off the triangular area where the mask had covered she could see a little more of a rash, like pinkish marbled rash but it would go away in about 45 minutes to 1 hour, started to slowly fade away. She felt that if it was a rash it would be all over her face; but this area was only where the face mask had been. She had no injury that could have caused that. The pain the next day was so bad, she was not able to sit or stand. She was barely rolling out of bed, had to hold on to furniture and walls to make it to bathroom. She is still not able to fully bend down. She has limit in movement. She still has pain, it did improve since the first day; but she still gets like a sore pain in the spine area, lower spine like a shooting pain from hips to connection where her legs meet bone which is still there. The pain can change from day to day; it can be on both sides of spine, or tailbone, hips, joints from where her legs attach to the hip area. Pain is a stabbing pain very painful and then the stabbing pains come and go and feels like a pulling pain, like a nerve pain but there is constant soreness in that area; on top of that still has the stabbing pain; this has been going on for the last 9 days did not have a break from this. She has tried massaging the area, tried Bengay on her back, tried ketoprofen (Ketonal), tried Capsaicin patches, Voltaren for the pain but none of those have helped the pain. Pain is a deep pain. The only thing that has helped it is like hot or thermal water bottle that you fill up with hot water which helps mute the pain to where it is manageable and helps her fall asleep at night. She still feels pain at time of call feels like a spinal injury. She experienced for 3 days; she would say on day number 3 (in 2021), the pain moved from the lower back to the half of buttocks on both sides and started getting numbness in buttocks and central part of buttocks like tingling pins and pricks feeling for maybe a day or 2 then it resolved. She still has pain in buttocks and hips and the pain can move to lower back and will hurt in lower back. Then on 04May2021, symptoms like entire intestines hurt her, she wasn't eating, it started at night when she was going to bed; so she is thinking maybe the pain is radiating to other parts of body to like her lower abdominal area; she used the hot water rubber bottle to relax muscles. She does not have the tingling sensation in her buttocks any longer; but does have tingling sensation in both hands and both feet that she sometimes feels, it is ongoing most of the time and is pretty severe. She feels pain getting up and down, still having pain; She is glad she can walk, because before walking was not very possible for her. She also tried a little bit of a back massage where she lay on her back and kind of wobbled on massager, but it doesn't help; the pain does not feel muscular it feels like something with the nerves. When she walks, she feels pain around her spine and lower back central part of spine, hips or lower back, like someone literally stabbed her in the back. She has seen her doctor on 03May2021 and was suggested seeing a neurologist before getting her second shot which is due 17May2021. Doctor ordered a blood panel and urine test and are still waiting for results (unknown results) taken on 03May2021. The patient asked if these are side effects of the vaccine. The patient did not know if she should or should not get the second dose relative to these events as of yet; second dose is scheduled for 17May2021. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The events resulted in physician office visit. Patient was not hospitalized. The patient recovered from events right side neck pain (felt like a pulled muscle), "right ear, it felt swollen", partial hearing loss, pressure on her ear, little pinkish rash/pinkish marbled rash, and jerking muscle in the left thigh and right thigh on 25Apr2021. The patient also recovered from event numbness in buttocks and central part of buttocks in 2021. The patient was recovering from events limited movement, difficulty walking, and heaviness on face. Outcome of events "felt woozy, felt a little drunk or funny", and "entire intestines hurt her" were unknown. While the patient had not yet recovered from the remaining events. No follow-up attempts are needed. No further information is expected.
35 2021-05-19 lip swelling, taste impairment, lip redness, mouth swelling, lip pain Intermittent hives and urticaria beginning three hours after vaccine, hives persisting 24 hours afte... Read more
Intermittent hives and urticaria beginning three hours after vaccine, hives persisting 24 hours after vaccine. 16 hours after vaccine experiencing red, painful, swollen lips/oral mucosa resembling sores (no prior hx of herpes simplex, possibly apthous ulcers), pale outter lip color. Metallic taste in mouth. Joint pain. Treatment of antihistamines and Tylenol, no improvement.
35 2021-05-19 lip swelling, swollen tongue Ten minutes after receiving the vaccine I started to break out in hives. My face swelled up includin... Read more
Ten minutes after receiving the vaccine I started to break out in hives. My face swelled up including my lips, throat, and tongue. Nurses at the clinic usetwo epipens and called 911. The paramedics used a third epipen, a breathing treatment, and sub q Benadryl. I was rushed to a nearby hospital and intubated and given more epinephrine, steroids, benadryl, pepcid, and an epinephrine IV drip.
35 2021-05-19 eye floaters Eye floater
35 2021-05-20 visual impairment Feeling a bit woozy, not quite dizzy, but like i am on some heavy medication or my blood pressure fe... Read more
Feeling a bit woozy, not quite dizzy, but like i am on some heavy medication or my blood pressure fell suddenly and too much. My blood pressure that i just measured is 100/67 with puls 65 - which is not unusual for me, (my standard blood pressure is about 96/65), but this is after a coffee too and a 32oz water. I can't focus easily if i am turning head from side to the other, takes like a second or so to stabilize gaze. The same thing happened with the first doze of vaccine i got. It got better the next day.
35 2021-05-21 mouth numbness Numbness on the side where the vaccine was administered: Left arm, left leg and calf, left palate, l... Read more
Numbness on the side where the vaccine was administered: Left arm, left leg and calf, left palate, left cheek, left side of the skin of the head. Headache. Especially on the forehead. Shooting pains in left leg and calf. Pain in knee and elbow on the left side. Sensation of compression in the chest. Fever and chills. Decline. Generalized muscle pain. Upper extremities pale especially in the hands.
35 2021-05-23 mouth numbness, loss of taste Lost in 30-50% of taste and numbness in tongue/face. Redness in face, unsure if swelling. No visual ... Read more
Lost in 30-50% of taste and numbness in tongue/face. Redness in face, unsure if swelling. No visual swelling, face "might be feeling puffy".
35 2021-05-23 mouth numbness Headache, crawling skin, lips and tongue numbness, fatigue, weakness (the previous things lasted abo... Read more
Headache, crawling skin, lips and tongue numbness, fatigue, weakness (the previous things lasted about 10 days) arm and hand numbness (lasted 12hrs).
35 2021-05-23 lip swelling, eye swelling Hives and swollen eye (3 days after shot), and swollen lip (10 days after shot)
35 2021-05-24 ear swelling, eye swelling began having severe itching, multi whelped rash all over body and swelling in face, hands, eyes, ea... Read more
began having severe itching, multi whelped rash all over body and swelling in face, hands, eyes, ears and feet. Went immediately to the ER where she received IM Benadry, IM Steroid and oral pepcid. Given a Rx for oral Prednisone 20 mg po q day x 5 days and to continue Benadryl 50 mg every 4-6 hours for 3 days. Rash and itching last for 5 days. Patient reported reaction to her PCP on 3rd day.
35 2021-05-24 visual impairment Patient reported via a "side effects survey" that her "eye sight decreased drastically for 4 days" f... Read more
Patient reported via a "side effects survey" that her "eye sight decreased drastically for 4 days" following vaccination (noted to have started within 4 hours of dose). No other care sought for this reported side effect.
35 2021-05-25 vision blurred, visual impairment Blurred, dimmed vision in left eye and tremors in left hand. Tremors began one week after injection ... Read more
Blurred, dimmed vision in left eye and tremors in left hand. Tremors began one week after injection so may be unrelated. The blurred and dimmed vision began almost immediately after injection and was significantly worse the following morning.
35 2021-05-25 visual impairment I had an auto immune response to vaccine - felt numbing in arm right after vaccine; I noticed it goi... Read more
I had an auto immune response to vaccine - felt numbing in arm right after vaccine; I noticed it going down my arm (the fluid from the injection). Once I left the building, I could feel that my face was numb and having tingling feeling .(Note: My neck sometimes causes me problems due to my pregnancy - before the vaccine - I was having an issue with my neck and that was going down into making my arms feel like they were going numb.) When my face went number, I had a hard time talking well for the next two or three days. My face and jaw were weak; my arms and hands were weak too. It went up my whole arm and on my torso (the numbness) - it was going up and down my body - it wasn't just staying in one place. I went to my mom's place and she gave me some juice. I did feel better when I had some juice but could tell I was having some kind of reaction. I did feel better when I drank the juice and some water. My husband met me for lunch and when I called him, I coughed - and I started seeing things around my eyes like I was going to pass out and I drank more water. I ate (burger) and I did feel a bit better. I was still having these issues with the numbness going from one part of my body to other. I drove home (30 minutes) and did feel a bit better. It felt like I was just "off" and not doing well - noticed I wasn't breathing as well. I noticed my heart was racing. I could feel my heart was having palpitations. I called the doctor for my pregnancy and she could tell I was trying to catch my breath. I was trying to stay calm through all of this and my mind wasn't racing. When I talked to her, she thought I should go to ER, she said I sounded out of breath and my heart was racing. At that point, I was nervous to drive, I was having some kind of vision problems - it was going in and out (like a disorientation). My husband drove me to ER. I drank some water though on the way and I felt better after doing that. I'm really sensitive to any kind of chemicals/drugs - I can be affected easily. (This is still within the first 2 hours after shot.) At ER, I drank more water. They told me not to take the 2nd vaccine at least while I was pregnant. They gave me Benadryl - IV 25 mg. And I felt so much better. Dr told me Benadryl can help with anxiety and with allergic reaction. The fast heartrate did go on for awhile - I did take Benadryl in the middle of the night that night and I had to take Benadryl through the next week or two to help sleep. I kept track of my heart rate because in the morning, I felt like I felt it more in the morning. I checked in with my doctor about it and she told me to watch it. It got up over 100 but it never got to the point that it was dangerous. Numbness finally went away eventually - it lasted about three or four days. My left eye was twitching - it took about three weeks for that to go away. I did get chills that night of the vaccine; I didn't get a fever. I slept - was so tired - I would get the meals for everyone but then take naps and I slept long at night and Benadryl helped with it. I did trip and fall the second or third day after the vaccine - I tripped on something - but I feel like I tripped because I was a little disorientated. I knew I had to be careful and take care of myself because of the symptoms. Four days after I had the shot, I got sick with COVID-like symptoms. Five days later I got a cough. I did not take a COVID test because other members of family tested and didn't have it. Pregnancy history - 6 pregnancies and 4 live births and the first one was a miscarriage. Due date: August 19, 2021
35 2021-05-26 ringing in ears I took second dose of Pfizer vaccine on May 8th. I felt arm pain and tired for three days since May... Read more
I took second dose of Pfizer vaccine on May 8th. I felt arm pain and tired for three days since May 8th. After 7-days when I took the 2nd Pfizer shot, I started getting heavy vertigo feeling. I've also had two brief episodes of room spinning dizziness, as well. At the same time, my tinnitus has increased in a variety of different sounds. I am so anxious. These symptoms last two weeks and I cannot relief.
35 2021-05-26 ringing in ears Slight ringing/buzzing sound in ears, has been slightly decreasing in the last day but still present
35 2021-05-27 eye disorder Experienced unilateral muscle spasms on left side. Eye twitching, bicep spasms, calf spasms
35 2021-05-28 mouth swelling headache/sharp shooting pain on the left side of her head; feeling sensational on the left side of h... Read more
headache/sharp shooting pain on the left side of her head; feeling sensational on the left side of her face; mouth is being swelling; cuts on her cheeks and on her tongue; extremely tired; sick; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the right arm on 07May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in Apr2021 in the right arm for COVID-19 immunization. The patient called to know if there was any research about people having any adverse effects with the shot. The patient stated that she went to the emergency room and saw the doctor and was hospitalized since she had a very several headache which started on 10May2021, over 6 days that has not gone away with medication (unspecified medication). The patient also stated that she has taken a shot (unspecified) for the headache and it worked for a little bit of time and the headache came right back. The headache is almost so bad it's giving birth, it's terrible. The headache has not been letting her take care of her children so she wants to know if there are researches that could help her situation. This happened right after she took a shot and does not have a history of headache ever. She has always been very healthy and so she believes it is the shot that is causing her the problem. She has a sharp shooting pain on the left side of her head. She has feeling sensational on the left side of her face (as reported), her mouth is being swelling, has cuts on her cheeks and on her tongue from swallowing. The patient stated that overall she is extremely tired and a lot of bad things has been happening ever since she took the shot over a week ago and she has been sick the whole time. The outcome of the events was unknown. Information about lot/batch number has been requested.
35 2021-05-28 swollen tongue Headache; Fever; Chills; Body aches; Swollen tongue; Low energy; Sore throat; This is a spontaneous ... Read more
Headache; Fever; Chills; Body aches; Swollen tongue; Low energy; Sore throat; This is a spontaneous report received from a contactable Other Health Professional. A 35-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number and expiration were not reported), via an unspecified route of administration in the left arm on 01Mar2021 at 20:00 (at the age of 35-years-old) as a single dose for COVID-19 immunization. Medical history included High blood pressure. No known allergies reported. Concomitant medications were not reported. The patient did not receive other vaccine four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced Headache, Fever, Chills, Body aches, Sore throat, Swollen tongue, and Low energy on 02Mar2021 at 20:00. No treatment medications were received for the events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
35 2021-05-28 ringing in ears Dizziness, off balance, weakness, brain fog, fatigue, ringing in ears, feeling faint, heart palpitat... Read more
Dizziness, off balance, weakness, brain fog, fatigue, ringing in ears, feeling faint, heart palpitations. Side effects started the day after the second dose of Pfizer vaccine and have NOT gone away. It has been three weeks since it all started.
35 2021-05-29 ringing in ears Intermittent dizziness and vertigo, lasting for a few hours 2 days after vaccine. Tinnitus in right ... Read more
Intermittent dizziness and vertigo, lasting for a few hours 2 days after vaccine. Tinnitus in right ear 3 days after vaccine.
35 2021-05-31 sensitivity to light, dry eye, hearing loss, visual impairment, eye itchiness, blindness in both eyes Memory fog, vision loss right eye, dry eyes, partial hearing loss in right ear. Multiple visits to e... Read more
Memory fog, vision loss right eye, dry eyes, partial hearing loss in right ear. Multiple visits to eye center. Dr diagnosed me with Encephalopathy. Seen my Dr. an audiologist at Center. Dr. diagnosed with partial hearing loss in my right ear. I had the actual Covid 19 virus in August of 2020. At that time I lost my sense of taste and smell for approximately 2 weeks. I had no long term side effects related to the virus. I received my first COVID 19 vaccine in December 23 2020. I had no side effects from that vaccine. The day after receiving my second Covid 19 vaccine, I started having light sensitivity, right eye itching, and visual disturbance of the right eye. Weeks later I started noticing changes in my ability to hear out of my right ear. Then people started noticing that I wasn?t hearing them appropriately. I?ve had multiple visits from specialist. I?ve had to buy new glasses, eye meds, contacts, take off work many times, and now I?m saving for a hearing aid. I was told by both specialist that the outcome is unknown at this time because there is not enough information on the virus and the vaccine to make that judgement.
35 2021-06-02 ear discomfort, ear pain, ear swelling Two weeks after the first dose I experience dizziness with ear pressure issues. My doctor is a neuro... Read more
Two weeks after the first dose I experience dizziness with ear pressure issues. My doctor is a neurological exam, said it was vertigo, and gave me meclizine. They said it could be from the vaccine, but they just don't know. Two weeks after the second I experience even more severe dizziness with ear pain, inflammation, ear pain, and felt worse. My doctor said this could be an inflation response to the vaccine and said my left ear was red and swollen. Gave me antibiotics and prednisone. A month later I had my annual checkup and explained I had three more dizziness and ear pain episodes. He then referred me to an ENT specialist. Today the ENT specialist said what I described does not sound like vertigo from my ear pressure issue. He said it could from medication or a health issue. He asked have I taken any new medication since February and I said the Covid vaccine. He said that could be causing the dizzyness, but there is also no way to know right now.
35 2021-06-03 eye pain, eye swelling Painful eye; Swollen eye; Body ache; Sore throat; Injection site pain; Headache; This is a spontaneo... Read more
Painful eye; Swollen eye; Body ache; Sore throat; Injection site pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration on left arm on 16Mar2021 at 18:30 hours (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient medical history included possible lupus and allergies (Zithromax, Spirolactin, sulfa and wool allergy). The concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and BENADRYL, taken within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 07:30 hours, the patient experienced painful, swollen eye, headache, body ache, sore throat and injection site pain (vaccination site pain). No treatment was received for the events. The clinical outcome of the all the events was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
35 2021-06-07 eye discomfort, bloodshot eyes, eye swelling it was an allergic reaction to the vaccine; left eye swollen; white part of the left eye turned yell... Read more
it was an allergic reaction to the vaccine; left eye swollen; white part of the left eye turned yellow; left eye is red; pressure to the left eye; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: EW0178; Expiration Date: 01Aug2021), via an unspecified route of administration, in arm left on 26May2021 at 11:00 (at time of vaccination was 35-years) as single dose for COVID-19 immunization. The patient had no relevant medical history. The patient did not receive any other vaccines within four weeks prior to COVID-19 Vaccine. The concomitant medications were not reported. On 27May2021 at 08:00, the patient had allergic reaction to the vaccine and experienced left eye swollen, white part of the left eye turned yellow, left eye is red, pressure to the left eye. The clinical course included: reporter stated that she got the Covid vaccine yesterday first round. Stated that her left eye was swollen and turned to yellow eye. Stated that it was the same side she got the shot on. Stated that her doctor told her that it was an allergic reaction to the vaccine and prescribed steroids. Stated that the pharmacist recommended not to get the second dose. The events left eye swollen, white part of left eye turning yellow resulted in Physician office visit. The outcome of the events was resolving. Information on Lot/Batch number is available; Further information has been requested.
35 2021-06-08 thirst Very mild arm soreness; felt dehydrated; mild headache; fatigue; This is a spontaneous report from a... Read more
Very mild arm soreness; felt dehydrated; mild headache; fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via an unspecified route of administration, administered in left arm, on 10Mar2021 at 10:45 (at the age of 35 years old) as 1st dose, single dose, for COVID-19 immunization; ethinylestradiol, etonogestrel (ETONOGESTREL/ETHINYLESTRADIOL MYLAN; batch/lot number and dose were not reported) vaginal ring via unspecified route of administration, from unspecified date, at an unknown dose and frequency, for an unspecified indication. The patient's medical history included exercise induced asthma and chronic bronchitis. Concomitant medications were not reported. The patient previously took aspartame and experienced headaches and nausea; and PERCOTCET and experienced vomiting, nausea and hives. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021 at 11:15 A.M., it was reported that the patient experienced very mild arm soreness, felt dehydrated starting about 30 minutes after the vaccine dose through the end of the day, very thirsty despite drinking a lot of water, mild headache and fatigue, moderate in the afternoon and more extreme towards the end of the day. The patient did not receive a treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The action taken in response to the events for etonogestrel/ ethinylestradiol was unknown. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
35 2021-06-09 dry mouth Heart inflammation; Dry mouth; Sore throat; Chills; Nausea; Fatigue; Cramped legs; Sore arm; Joint p... Read more
Heart inflammation; Dry mouth; Sore throat; Chills; Nausea; Fatigue; Cramped legs; Sore arm; Joint pain; Muscle pain; Extreme anxiety; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:30 at 35-years-old (Batch/Lot Number: ER8729) as 1st dose, single for COVID-19 immunization. There was no medical history. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included paracetamol (TYLENOL). The patient had dry mouth, sore throat, chills, nausea, fatigue, cramped legs, sore arm, joint pain, muscle pain, extreme anxiety, chronic chest pain lasted for 5 days constantly and ER visit Dr. says it was due to the vaccine: heart inflammation. Happened to 50% of chest pain ER visitors due to vaccine 3-4 days after vaccine dose. And should only last 6 days. Heart inflammation should be added to info packet and more studies should be done asap. All events started on 22Apr2021 03:30. No treatment given. Outcome of events was recovered in 2021.
35 2021-06-09 ear congestion Nausea morning after, extending through second day after Dizziness Ears felt congested Hot flashes... Read more
Nausea morning after, extending through second day after Dizziness Ears felt congested Hot flashes Treatment: rest, fluids, took time off work
35 2021-06-09 ear pain Sharp pains in rt orbital bone and sharp pains in rt ear
35 2021-06-10 mouth tingling UrticariaPruritus Narrative: 1445: C/O ITCHING rt arm and tingling of lips. 125/84 75 100% RA RR 1... Read more
UrticariaPruritus Narrative: 1445: C/O ITCHING rt arm and tingling of lips. 125/84 75 100% RA RR 12..SX resolved @ 1457 INTERVENTIONS: ICE PACK AND WATER
35 2021-06-11 lip swelling Excess stomach acid within 5-10 minutes. At 1 hour, upper lip swelling. I took 50mg Benadryl and th... Read more
Excess stomach acid within 5-10 minutes. At 1 hour, upper lip swelling. I took 50mg Benadryl and the swelling went down after an hour. At 3 hours I became overly sleepy, and elbow and knees began to ache.
35 2021-06-14 ear discomfort Extreme diziness, left arm numb and tingly, bad brain fog, dizziness has not stopped since 4 days af... Read more
Extreme diziness, left arm numb and tingly, bad brain fog, dizziness has not stopped since 4 days after vaccine, every day. Cannot complete simple tasks at work as fast, hard to concentrate, pressure in ears, balance feels off. Hard to manage day to day routine with my kids, dizzy all the time, This is affecting my work, my lifestyle and every day concentration
35 2021-06-16 loss of smell Headache; nausea; loss of smell; congestion; runny nose; cough; body aches; I feel sometime hot some... Read more
Headache; nausea; loss of smell; congestion; runny nose; cough; body aches; I feel sometime hot sometime I feel chill; I feel sometime hot sometime I feel chill; feel cold; Back pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0187), at same age, as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history includes coronavirus infection. The patient concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0167), for covid-19 immunisation. Patient was experiencing symptoms like she did when she previously had the coronavirus infection and wanted to know if it could be side effects of the vaccine or if she was infected again. Her symptoms included headache, nausea, loss of smell, congestion, runny nose, cough and body aches. Patient felt sometime hot sometime she felt chill, she felt cold she felt like that way too. She got a congestion and later be headache and cough then after Friday it's getting worse and worse like she start feeling lot of headache yesterday and then nausea and back pain, the cold and the hot and have a lot of cough. For anatomical site of vaccine, consumer stated, for first dose on the left and second dose on right. The outcomes of events were unknown.
35 2021-06-16 eye disorder Right facial paralysis, right eye vision issues, mild left facial drooping.
35 2021-06-16 lip swelling, dry mouth, chapped lips, mouth discomfort Lips went totally white and chapped, burning all around my lips began (day after shot) Burning got w... Read more
Lips went totally white and chapped, burning all around my lips began (day after shot) Burning got worse the next day around my mouth, lips got even more chapped (two days after) Ate something I've never reacted to before for dinner after dinner my entire face broke out in rash, my lips swelled up, my throat swelled, blood pressure dropped, heart raced, and I was about to faint (so lay down). Stopped reaction with two benedryl. (three days later) - note this sort of thing has happened before after certain drugs when taken in aggregate over days (Malarone, Gabapentin) For next 4 weeks I had a host of symptoms that were unliveable including (note: some have lasted longer) - Fainting spells, low blood pressure - Full body nerve pain and facial nerve pains that were very intense - Dry mouth - Tachycardia at night (RAPID heart beat) - Lip angioedema usually in the morning only to be controlled with antihsitimines (still the case months later) - Massive diarrhea usually in the morning with lip angiodema - Trouble breathing and chest pain and wheezing, one massive asthma attack Treatment: Antihistimines at first, but made POTS too bad so went off (helped swelling though) Steroid inhaler to help me breath Steroids (prednisone) burst in late April/early May - moderately helpful when on the course, but made digestive issues worse and acid reflux worse, lip burning and swelling came back after i went off this Post-Steroid burst: - Still having lip burning - Still having horrible dry mouth - Still trouble breathing and wheezing and shortness of breath - horrible digestive issues (acid reflux) - nerve pain Treatment post steroids - treated my MCAS - Quercetin, Vitamin C, and NAC, eventually found compounded allegra to work without the dysautonomia side effects and now on 180mg / day has helped a lot of these symptoms - Using Cromolyn Sodium nebulized for the breathing issues and chest pain - helping a lot for this! With the MCAS drugs I'm improved, but I still have the following (June 16) - horrible acid reflux all day every day (doesn't matter what I eat) - Dry mouth - I also have lip burning that is pretty constant (although swelling is down) - Moderate wheezing (but its better than before) - Moderate facial pain (but better than before) - Headaches (pretty sure it's a side effect of my meds)
35 2021-06-16 pain in jaw Chest pain in heart area (aching/tightening feeling) lasting for about 5-10 minutes and did not less... Read more
Chest pain in heart area (aching/tightening feeling) lasting for about 5-10 minutes and did not lessen with movement. Radiated down left shoulder. Intermittent for about 12 hours. Happened a total of about 4 times. 1x shooting pain through jaw lasting about 2 seconds.
35 2021-06-17 ringing in ears, deafness, ear discomfort Ear fullness that lead to tinnitus and hearing loss in left ear
35 2021-06-18 smell distorsion, taste disorder On March 23, 2021 I began to have a distorted sense of taste and smell. Everything smells like very... Read more
On March 23, 2021 I began to have a distorted sense of taste and smell. Everything smells like very rotten meat and everything tastes how it smells. I have been unable to eat meat protein, nut protein, protein shakes and most other proteins (the only protein I am able to eat is cheese) since that day, it has only been within the last week that I have been able to eat cooked sea bass and raw salmon. Protein is not the only thing I am having issues with, and toasted, cooked or warm food is inedible. I also tested positive for Covid-19 on March 25, 2021 (after I received both pfizer vaccines)
35 2021-06-18 visual impairment I developed retinal ischemia in my right eye after both doses of the Pfizer vaccine. The first time ... Read more
I developed retinal ischemia in my right eye after both doses of the Pfizer vaccine. The first time was 10 days post inoculation, when it occurred out of the nowhere after feeling intense sinus pressure. I went to my ophthalmologist within hours who sent me to a Retinologist the next day. She dismissed it as possibly from sex the previous night but did order blood tests. Two of them came back positive: ANA and Beta 2 Glycoprotien 1,IgM (38.6). I have no prior blood clotting issues and my 2d echo and carotid scans came back normal. While waiting for the test results I went for my second dose? about 14 days later, same pressure and then my vision suddenly got worse in the same eye. The pictures of the eye show that it did get worse and different patterns. After talking with my Retinologist?s partner at her practice (she wasn?t available) we decided to try low dose aspirin until I could be seen by a Rheumatologist? and it did clear up a little. I was then sent to a rheumatologist who said my numbers weren?t enough to cause alarm for Antiphospolipid disease and to get retested in late July and keep taking the low dose aspirin. I have since seen my Retinologist again and she says she has never seen anything like this before in her decades of practice. I am healthy and physically active with normal blood pressures. I?m 5?5? 135lbs with no prior blood clotting issues or any medical issues besides arthritis in my cervical vertebrae, I have two healthy pregnancies and no miscarriages.
35 2021-06-21 dry mouth Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: dry mouth-Mild, Addit... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: dry mouth-Mild, Additional Details: 5 mins after covid vaccine, pt was holding head in hands during observation period. stated she was very weak and lightheaded, had no difficulty breathing, was moved to the floor, still lightheaded, began to have chills, and slight dry mouth, no change in breathing, ems arrived, she started to feel better, declined offer to go er, ems checked vitals, said blood sugar was a little low, the rest normal.
35 2021-06-21 dry mouth Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: dry mouth-Mild, Addit... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: dry mouth-Mild, Additional Details: 5 minutes after recieving vaccine, patients put head in hands during observation period. when I went out to check on her she said she was very weak, and was starting to slide off the her chair, moved pt to the ground, where she stated she was getting chills, covered her with white coat, she remained coherent, added her mouth was dry, was told to take deep breath the entire time, and stated she was not having any difficulty breathing, EMS arrived, she did not go to Hosp.
35 2021-06-23 tongue disorder inner ear not able to find my balance feeling; off balance; numbness turned into pins and needles; m... Read more
inner ear not able to find my balance feeling; off balance; numbness turned into pins and needles; my numb legs began twitching uncontrollable; I was not able to walk or lift my legs; my feet began going numb. The numbness climbed up my legs to where my legs attach to my torso. I also experienced numbness in my hands and arm, cheeks; my tongue became heavy; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jun2021 14:15 (Batch/Lot Number: EW0177) as single dose for covid-19 immunisation at the age of 35-year-old. Medical history included Congenital deafness/hard of hearing. Sensory processing disorder and allergic to Septra (co-timoxazole). There were no concomitant medications. The consumer reported about 10 minutes after the shot, my feet began going numb. The numbness climbed up my legs to where my legs attach to my torso. I also experienced numbness in my hands and arm, cheeks, and my tongue became heavy. About 25 minutes after the shot, I was not able to walk or lift my legs. This was extremely scary. About 40 minutes after the shot, my numb legs began twitching uncontrollable. The twitching lasted about 10 minutes. About 2 hours after my shot I was able to walk again and the numbness turned into pins and needles. At about 7 hours after the shot the pins and needles subsided. The next morning I felt like I was on a ship. It was not a dizzy feeling, but more of an inner ear not able to find my balance feeling. I am still off balance. The pins and needles comes and goes. The events resulted in doctor or other healthcare professional office/clinic visit and prolonged hospitalization. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination. Follow-up attempts are needed. Further information is requested.
35 2021-06-23 tongue itchiness Anaphylaxis After 5 min - tongue itching After 10 min - anxious feeling, dizziness, tingling After ... Read more
Anaphylaxis After 5 min - tongue itching After 10 min - anxious feeling, dizziness, tingling After 15 min - wheezing, difficulty breathing
35 2021-06-24 eye disorder, bloodshot eyes, vision blurred, eye irritation, eye swelling Eye was being irritated to blink or rub it; Is still able to see, but is very blurry; Felt like some... Read more
Eye was being irritated to blink or rub it; Is still able to see, but is very blurry; Felt like someone was scratching her eye with sandpaper; It woke her out of her sleep; Eye swelled up; White of her eye was red as if she had pink eye; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 27Jan2021 as SINGLE DOSE for covid-19 immunisation. Medical history included allergies, sinus drain through her nose and eyes will dry out (no, allergies and sinus drain through her nose and her eyes will dry out. Dr. said that was not the cause.). There was no corneal abrasion. She has no pink eye. It was very irritated and swollen. Historical vaccine included BNT162B2 for COVID-19 immunisation (Received both doses in her right arm). There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for COVID-19 Since the vaccination. On 28Jan2021, 1 Day after vaccination the patient experienced eye swelled up and white of her eye was red as if she had pink eye. On an unspecified the patient experienced eye was being irritated to blink or rub it and was still able to see, but was very blurry, felt like someone was scratching her eye with sandpaper, it woke her out of her sleep. Only blurry when the light would hit it. She put hot towels on it. White of her eye was almost puffing out and white of her eye was red as if she had pink eye. On an unknown date, the patient underwent lab tests and procedures which included eye pressure (eye pressure was checked and was good) and eye stain with unknown results (eye stain to make sure it wasn't scratched). The patient went to eye doctor on Tuesday. Eye pressure was checked and was good. The patient took Prednisolone Acetate 1% (NDC: 60758-119-05, Lot: 91118PY, E89581 and Exp: May2023), one drop 4 times a day for ten and left eye. The patient had to get a steroid eye drop from the doctor on Tuesday. The outcome of events was unknown. No follow-up attempts possible. No further information expected.
35 2021-06-24 smell distorsion Feel little stinks; Headache; Feel like tired; Chilling; Muscles pain; Cold; This is a spontaneous r... Read more
Feel little stinks; Headache; Feel like tired; Chilling; Muscles pain; Cold; This is a spontaneous report from a contactable consumer or other non hcp. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Feb2021 (at the age of 35 years old), 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got the shots of COVID-19, yesterday (03Feb2021) was her second shot and feels little stinks, she has headache, feel like tired, chilling, muscles pain and cold. And she wants to know if it is, on it paper it is normal but for her but like for like her family. The number 82, so the name of the shot they told her, she has a number, and it is 82, she don't know if it is that one. Therapeutic measures were taken as a result of muscles pain. The outcome of the events was unknown. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
35 2021-06-28 deafness, ringing in ears SAhortly after taking the shot, I have had non stop static buzzing noise in both my ears that does n... Read more
SAhortly after taking the shot, I have had non stop static buzzing noise in both my ears that does not go away. After several weeks the volume of the static buzzing noise increased. I went to my primary doctor and then an ENT (ear specialist) and was diagnosed with Tinnitus. Previously before the vaccine I was completely healthy and had no history of any ear related medical issues. I also have been having heart pain on my chest. It is due to my heart valve being inflamed. Anti inflamatory were prescribed but did not help much. I am scheduled to see a cardiologist.
35 2021-06-28 ear pain Patient received 2nd dose of Pfizer Covid vaccine, Lot: EW0187 on 6/27/2021. Same day patient starte... Read more
Patient received 2nd dose of Pfizer Covid vaccine, Lot: EW0187 on 6/27/2021. Same day patient started to feel tired, sleepy and had headache, improved with Tylenol. Following day 6/28, patient reports feeling itching on neck and hands. Painful ears, R worse than L. The outer ears are tender, painful to touch and appear red. Patient denies any fever or drainage from ear. No problems with hearing. Denies any swelling of face, lips or throat. No Shortness of breath. Speaking in full sentences over the phone during report. Patient reported some relief yesterday after taking Benadryl. Calling for advice today. Patient advised to monitor symptoms, take Benadryl as needed. Don't drive while taking Benadryl. Advised to call MD/Urgent Care. Emergency room precautions reviewed for any worsening of symptoms; SOB, Swelling of face, throat and lips etc. Patient verbalized understanding of all provided instructions and agreed with plan.
35 2021-06-28 mouth numbness, ear pain Bell's Palsy. Started with ear pain and then tongue numbness. Went to ER with just ear pain and tong... Read more
Bell's Palsy. Started with ear pain and then tongue numbness. Went to ER with just ear pain and tongue numbness and at the time you could just start to see the weakness in the facial muscles. It got much worse over the next couple of days.
35 2021-06-29 loss of smell, loss of taste Experiencing loss of smell and taste, which started 24 hours or so after the vaccine and progressive... Read more
Experiencing loss of smell and taste, which started 24 hours or so after the vaccine and progressively getting worse (at day 5 now)
35 2021-06-29 eye pain, bloodshot eyes some shortness of breath on exertion; Headaches; joint pain; body aches; eye soreness; red eyes; bra... Read more
some shortness of breath on exertion; Headaches; joint pain; body aches; eye soreness; red eyes; brain fog; severe fatigue; pain around back and ribs; pain around back and ribs; pain at back of neck; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received BNT162B2(PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection, Lot number: EN6199, Expiration date: Not reported) via an unspecified route of administration, administered in arm left on 05Mar2021 14:30 as DOSE 1, SINGLE for COVID-19 IMMUNISATION. Medical history included Post-acute covid 19 syndrome, chronic fatigue syndrome, COVID-19, migraine and sick from Mar2020 to an unknown date. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), nortriptyline and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). Patient did not receive any vaccine in four weeks. On 11Mar2021, at 8.00 patient experienced headaches, body aches, joint pain, eye soreness, red eyes, brain fog, severe fatigue, pain around back and ribs, pain at back of neck, some shortness of breath on exertion. She reported to have post acute covid 19 syndrome since getting sick in Mar2020 and this has been a severe relapse, after several months of improvement. She received unspecified treatment for the events. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
35 2021-07-01 inability to speak The next morning felt very dehydrated and a lot of pain on my arm and on my body. As the day progres... Read more
The next morning felt very dehydrated and a lot of pain on my arm and on my body. As the day progressed my throat started to hurt bad. The third day I lost my voice. I went to the urgent care and they said I had inflammation on my throat that was the only visual symptom they could see on my body, everything else looked normal. They did a strep test but it came back normal. My voice returned after three days but I had issues with my throat for seven days total.
35 2021-07-01 lip swelling Swollen lips; stabbing pain on right breast; This is a spontaneous report from a contactable consume... Read more
Swollen lips; stabbing pain on right breast; This is a spontaneous report from a contactable consumer, the patient. A 35-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the right arm on 21Mar2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included as myomectomy to remove uterine fibroids on an unknown date in Oct2020 and had lip injection one year ago. Concomitant medication included PEPCID for unspecified indication. The patient was not allergic to any medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the right arm on 21Feb2021 at 17:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 22Mar2021 at 16:00, the patient experienced swollen lips and stabbing pain on right breast (same side as vaccination). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. The clinical outcome of swollen lips and stabbing pain on right breast was recovering. No follow-up attempts are needed. No further information is expected.
35 2021-07-01 lip swelling itch; Pain; I got the 1st vaccine a dark red spot started to show on the right side of my jaw; The r... Read more
itch; Pain; I got the 1st vaccine a dark red spot started to show on the right side of my jaw; The rash covered the bottom of my face around one eye; my left three fingers are still scabby; During my period that month after the vaccine, I also had very large blood clots. Two of them size of small grapefruit.; everything I used on it made it burn; I couldn't sleep; swelled my face for two weeks, There was a hard knot in my jaw.; Lips felt swollen; anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient herself). A 35-years-old non-pregnant female (not-pregnant at the time of the vaccination) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0150; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 07Apr2021 11:00 (at the age of 35-years-old) as first dose single for COVID-19 immunization at Hospital. Medical history included non-compaction cardiomyopathy. Patient had known allergies Sulfur, sulfites, Penicillin, Sea Food, Cortisone, MSG. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included other medications the patient received within 2 weeks of vaccination was Metoprolol Tartrate (METOPROLOL TARTRATE) taken for an unspecified indication. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. It was reported that, two days after she got the 1st vaccine, on 09Apr2021 03:00pm a dark red spot started to show on the right side of her jaw. That soon started to itch. It swelled her face for two weeks. There was a hard knot in her jaw. She treated it like poison ivy but everything she used on it made it burn. The only thing that helped the itch and pain was Benadryl every four hours or she could not sleep this lasted for two weeks. The rash covered the bottom of her face around one eye. Down both arms and left side of her breast down the stomach. This rash also blustered on hand and other parts of her arm. It finally started really go away after three weeks. It had been four weeks and could see her left three fingers were still scabby. During her period that month after the vaccine, she also had very large blood clots. Two of them size of small grapefruit. On 09Apr2021 at 15:00, The patient got the 1st vaccine a dark red spot started to show on the right side of my jaw itch, Generalised rash began Right antecubital with itching red patch then spread to chest back neck extremities lips felt swollen. The symptoms occurred after 2 days after administration of vaccination. The reporter described all the signs and symptoms of the anaphylactic reaction: Generalised rash began Right antecubital with itching red patch then spread to chest back neck extremities lips felt swollen, anaphylactic reaction occurred 2 days after immunization administration. Patient visited Doctor or other healthcare professional office/clinic visit due to AE resulted. The Multi organ involvement included Lips felt swollen, Dermatological/ Mucosal, Generalized Pruritis with skin rash, included began Right antecubital with itching /ed patch then spread to chest back neck extremities. The patient was not hospitalised. Therapeutic measures were taken for adverse events which included cetirizine 10mg, famotidine 20mg and diphenhydramine 25mg, antihistamine. The outcome of the events were resolved on an unspecified date in 2021. The reporter stated that the reported adverse event(s) with the use of the product. The Pfizer product had a casual effect to the adverse event. Information about batch/ lot number has been requested. Follow-up(17Jun2021)This is a follow up spontaneous report from a contactable other HCP. This other HCP reported in response to DCA letter sent via Follow up letter which included that: suspect details (Lot number, route of administration, anatomical location), Event information, Treatment, concomitant medication, causality were added and updated.
35 2021-07-01 vision blurred, dry throat, dry mouth fluctuating temperature; blurry vision; dry mouth; dry upper throat; lightheadness; tingling inside ... Read more
fluctuating temperature; blurry vision; dry mouth; dry upper throat; lightheadness; tingling inside mouth and aroundjaws area.; This is a spontaneous report from contactable consumer, the patient. A 35-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: unknown), via an unspecified route of administration on 20Mar2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had a medical history of allergies to penicillin, dairy and mango. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 (5-10 minutes after vaccine administration), the patient experienced blurry vision, dry mouth and upper throat, followed by light-headedness, and tingling inside mouth and around jaws area. The light-headedness went away within five minutes, the dry mouth and tingling feeling held longer, later that day had more episodes of light-headedness. The patient experienced following day on (21Mar2021) (Sunday), while felt ok for most part, had fluctuating temperature that was sometimes high and sometimes normal, and had a few more light-headedness episodes, neither continued into Monday except for one lightheaded episode. The patient added that she was not stressed prior to vaccination, her whole family was vaccinated in (country name), and not had any issues. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of blurry vision, dry mouth and upper throat, light-headedness, tingling and fluctuating temperature was recovered on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.
35 2021-07-08 feeling of choking Patient recieved the pfizer. Her 1st shot approximately 712p, She felt "heavy" shortly after shot. ... Read more
Patient recieved the pfizer. Her 1st shot approximately 712p, She felt "heavy" shortly after shot. 732p 50mg of Benadryl was given as she describes tingly and swelling of throat. The Benadryl appeared to relieve symptoms and patient asked to leave at 755pm. Patient was Conscious and alert through reactions, and no outward symptom seen.
35 2021-07-09 vision blurred Hives 3 days, headache, blurry visión, extreme gatigue lower back pain, nack pain, Muscle pain in l... Read more
Hives 3 days, headache, blurry visión, extreme gatigue lower back pain, nack pain, Muscle pain in legs, jitery
35 2021-07-11 eye bleeding Blood vessel in eye burst; Missed period; This is a spontaneous report from a contactable consumer o... Read more
Blood vessel in eye burst; Missed period; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:30 (35-year old at the time of vaccination) (Batch/Lot Number: EN6204) as DOSE 1, SINGLE for covid-19 immunisation. Medical history reported as none. Concomitant medications was not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications received within 2 weeks of vaccination. On 17Mar2021 15:30 the patient experienced blood vessel in eye burst and missed period. Patient did not receive any treatment for the adverse events. The reported seriousness of the event was medically significant. The clinical outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
35 2021-07-11 photosensitivity reaction Heavy vaginal bleeding for 2 weeks; Severe migraine that wont go away; Diarrhea; chills; fever; High... Read more
Heavy vaginal bleeding for 2 weeks; Severe migraine that wont go away; Diarrhea; chills; fever; High blood pressure; Hands randomly turn red and burn; Hands randomly turn red and burn; phlegm; headache; body aches; nausea; sun sensitivity and sunburn last 2 weeks; sun sensitivity and sunburn last 2 weeks; This is a spontaneous report from a contactable other Health Care Professional. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199 and Expiry date: Unknown)via an unspecified route of administration, administered in left Arm on 05Mar2021 at 10:45 as Dose 2,Single for COVID-19 immunization. The patient's medical history included endometriosis, Allergies to medications, food, or other products PNC, tetracycline, and methlyparaben. Patient took first dose of bnt162b2 (-PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201 was not reported) on 12-FEB-2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and on 18Mar2021has been tested for COVID-19 resulted in Negative.On 05Mar2021 the patient experienced heavy vaginal bleeding for 2 weeks, severe migraine that wont go away, diarrhea, chills, fever, high blood pressure, hands randomly turn red and burn, phlegm, sun sensitivity and sunburn last 2 weeks, nausea, body aches, headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021.Therapeutic measures were taken as a result of the adverse events. Patient's treatment for the adverse event included Headache cocktail, imitrex, steroids, zofran, bent. On Mar2021 the outcome of events Heavy vaginal bleeding for 2 weeks, nausea, body aches, was recovered while the outcome of events Severe migraine that wont go away , Diarrhea , chills , fever , High blood pressure , Hands randomly turn red and burn,phlegm ,sun sensitivity and sunburn last 2 weeks,headache was not recovered .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Vaginal hemorrhage, Migraine, Diarrhea, Chills, Pyrexia, Blood pressure increased, Erythema, Burning sensation, Productive cough, Photo sensitivity, Sunburn and Headache and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
35 2021-07-12 lacrimation increased I was on my period when I received shot #2 15Apr2021 I only had a few days left in that cycle I star... Read more
I was on my period when I received shot #2 15Apr2021 I only had a few days left in that cycle I started my next cycle regularly 08May2021 but it was incredibly heavy and excruciatingly painful; I was on my period when I received shot #2 15Apr2021 I only had a few days left in that cycle I started my next cycle regularly 08May2021 but it was incredibly heavy and excruciatingly painful; I was feeling extremely depressed again, teary and sad and not sure why; Very very tired; Unmotivated; I was feeling extremely depressed again, teary and sad and not sure why; excruciatingly painful; This is a spontaneous report from a contactable consumer. A 35-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EWC158) via an unspecified route of administration, administered in arm right on 15Apr2021 at 07:45 (at the age of 35-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EP6955) in left arm on 25Mar2021 at 12 pm for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID post vaccination. There were no known allergies. There was no prior COVID vaccination. I was on my period when I received shot #2 15Apr2021 I only had a few days left in that cycle I started my next cycle regularly 08May2021, but it was incredibly heavy and excruciatingly painful, I was also much more sad, depressed, exhausted than normal. The feelings of depression were extremely overwhelming. This week (24May2021) I was feeling extremely depressed again, teary and sad and not sure why, very very tired and unmotivated, started my period again only 12 days later 27May2021. The patient did not receive any treatment for the events. The outcome of the events was recovering. Follow-up attempts are completed. No further information was expected.
35 2021-07-13 deafness unilateral, sudden hearing loss Spontaneous hearing loss in right ear accompanied by extreme dizziness and nausea. The nausea and di... Read more
Spontaneous hearing loss in right ear accompanied by extreme dizziness and nausea. The nausea and dizziness subsided within 2 weeks but the hearing loss continues.
35 2021-07-13 eye floaters On February 2nd I started experiencing tingling and twitching in my arm and face. On the 3rd I devel... Read more
On February 2nd I started experiencing tingling and twitching in my arm and face. On the 3rd I developed shingle blisters on the left side of my abdomen. A week later I had the burning sensation of shingles all over my body. I continue to have weakness in my right arm and leg, tingling in my right hand and sparkling floaters in my vision. I have had a MRI of my brain. They identified telangiectasia on my pons and they also found a legion on my left frontal temporal lobe. My neurologist ordered a MRI of my neck which came back clear. On July 6th I had a lumbar Cap analysis my spinal fluid and on July 12th I had to have a blood patch because I had a spinal fluid leak.
35 2021-07-16 permanent deafness, deafness unilateral, sudden hearing loss Sudden unilateral sensorineural hearing loss, mild. Treated with oral prednisone. Symptoms fully res... Read more
Sudden unilateral sensorineural hearing loss, mild. Treated with oral prednisone. Symptoms fully resolved.
35 2021-07-17 eye twitching This is a spontaneous report from a contactable consumer. A 35-year-old non-pregnant female patient ... Read more
This is a spontaneous report from a contactable consumer. A 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 13Mar2021 at 17:15 (at the age of 35-years-old) as a single dose for COVID-19 immunization. Medical history included mitral valve prolapse and COVID-19. The patient was not allergic to food, medication or other product. The patient had no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021, the patient experienced immediate shoulder discomfort. On 14Mar2021 at 01:15 (8 hours later), The patient's arm felt like it was broken and unable to lift away from body without excruciating pain. On 14Mar2021, the patient developed a 102 fever (units unspecified). On 14Mar2021 (24-32 hours later), the patient experienced severe arm pain subsided and shoulder joint pain when lifting above her head and to the right alongside dull aches when resting. On 14Mar2021, the patient underwent test for body temperature and the result was 102 (unspecified units). On 15Mar2021 (on Monday), the patient's left upper eyelid began twitching persistently and through the day. The patient also experienced twitches in legs, and elbows on both sides more so on left and arch of foot. The patient did not receive any treatment for the event. On 08Dec2020, the patient underwent COVID-19 virus test and the result was found to be positive. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event shoulder discomfort, arm felt like it was broke, severe arm pain and unable to lift away from body without excruciating pain, fever (102), joint pain in the shoulder of injection and shoulder joint pain, left upper eyelid twitching and twitches (legs, elbows on both sides on left and arch of foot) were not resolved at the time of this reports. No follow-up attempts are needed. No further information is expected.
35 2021-07-17 lip swelling allergic reaction; my stomach was really sore; my lips were swollen, I couldn't close my mouth; itc... Read more
allergic reaction; my stomach was really sore; my lips were swollen, I couldn't close my mouth; itchy; hives, on my buttocks, hips, chest area; injection site was really itchy; nauseated; injection site was really sore; stomach cramps; This is a spontaneous report from a contactable consumer reported for herself. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration in arm left on 07Apr2021 as dose 1, single for COVID-19 immunization. Medical history included food allergies, medicine allergy, acetaminophen all from an unknown date and unknown if ongoing. Concomitant medications were not reported. No history of all previous immunizations with the Pfizer vaccine considered as suspect, no prior Vaccinations within 4 weeks. On 08Apr2021, patient experienced an allergic reaction, occurred when I woke up the next morning, my stomach was sore, it is typical when I eat something, I am allergic to. That night around 10pm, I went to sleep, my lips were swollen, I could not close my mouth. I looked like a fish, I woke up because I was itchy, I thought it was my hair. when I went to brush my teeth, my lips were swollen, I checked, I had hives, on my buttocks, hips, chest area. On 07Apr2021 I felt nauseated, slept with a bucket, but nothing came out. My sister is a nurse, she said watch out for allergies. Woke up thinking that this is an allergic reaction what is happening with my stomach. The injection site was sore. It started by the time I got home, and I had my vaccine at 3:35 3:40, 07Apr2021, that afternoon, kind of sore already, it lasted like I could not move it until Friday. The injection site was itchy. She is so over this, she is unable to be able to move around, just to be safer, her stomach was hurting, she had food allergies and medicine allergies, that is typical of her when she had food allergy. She always uses her eyes as an indicator if things are getting worse, but she could still open her eyes and did not check it throughout the night, she knows her stomach wasn't in the best shape though. She doesn't have a history of anaphylactic shock. It was reported by the patient that website says, if she had a non-emergent reaction within 4 hours of getting the shot, not to get the second shot, but she didn't have it within 4 hours and if she has a medicine or food allergy, a person can still take it, so now she is confused. On Apr2021, she is not sure about stomach cramps. Throughout the night I could feel my stomach is in pain, with stomach cramps, states she was not feeling well, her stomach was rumbling, but it is because she could not really eat that much. She is not sure if that when it started or just when she was sleeping and verified began 07Apr2021 or 08Apr2021. She took medication for it, she took it the following morning when she had swelling of her lips, she took 50mg of an antihistamine, which that worked and states it knocked her out. She states the stomach cramps stopped, but then when it wore off, they came back, lips resolved by itself, they never really went away because of the medication, the antihistamine helped with her stomach cramps. It was Diphenhydramine, its Benadryl but off brand (LOT: P120041 EXP: 05/2022 NDC: 63981-329-78 Dosage: 25 mg Capsules: 600 tablets). She took 50mg, two tablets, A sample of the product available to be returned, if requested, packaging sealed and intact. The only time she took the medicine was Thursday morning and Friday morning again because she still wasn't feeling well. On Saturday, she was okay, no more hives, no other symptoms. Caller states her lips still felt a bit like it was still swollen, but she couldn't even see it in the mirror, but she felt it, like a numbing sensation when she had the swelling. And states she could feel it, but she could not even see it like when it was swollen. Saturday night she was okay because she was already eating. Site being painful, arm was sore, itchy it is just on that spot where the needle went in, around it, is all better but sometimes, she had long hair, when her hair goes on it, on accident she would scratch it and that area where the injection, the needle came in, its still sore. The clinical outcome of the event allergic reaction, my stomach was sore was unknown, the event injection site was sore, injection site was itchy was resolving, the event nauseated, stomach cramps, on 09Apr2021 was resolved and the event my lips were swollen, I couldn't close my mouth, itchy, hives, on my buttocks, hips, chest area on 10Apr2021 was resolved.
35 2021-07-17 thirst been very thirsty; headache; left arm is very sore like if had been punched several times; This is a... Read more
been very thirsty; headache; left arm is very sore like if had been punched several times; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248), via an unspecified route of administration in the left arm on 24Mar2021 at 15:15 (at the age of 35-years old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 35-years old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 15:30, after receiving the vaccine, the patient had a headache shortly afterwards that lasted a few hours. Her left arm was very sore like if had been punched several times. The patient had been very thirsty. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events headache, left arm is very sore like if had been punched several times and been very thirsty. The clinical outcomes of the events headache, left arm is very sore like if had been punched several times and been very thirsty were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
35 2021-07-17 eye floaters Extreme exhaustion; pain at injection site; headache; dizziness; sore throat; Seeing spots; Breath f... Read more
Extreme exhaustion; pain at injection site; headache; dizziness; sore throat; Seeing spots; Breath fog; This is a spontaneous report received from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER3789) via an unspecified route of administration in the left arm on 26Mar2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. It was reported that patient received unspecified medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient experienced extreme exhaustion, pain at injection site, headache, dizziness, breath fog, was seeing spots, and sore throat. The adverse events did not result in doctor or other healthcare professional office/clinic visit, or emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of events extreme exhaustion, pain at injection site, headache, dizziness, breath fog, seeing spots and sore throat was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
35 2021-07-18 taste disorder Fatigue, swollen left arm very painful arm and breast limp notes. Whole body pain very weak, headach... Read more
Fatigue, swollen left arm very painful arm and breast limp notes. Whole body pain very weak, headache, stomach cramps leading to diarrhea. Cold chills, nasty sick taste in my mouth. I also had a shooting pain going from my left arm and back to my leg. Cold hand on left arm where I was vaccinated. Slept for hours had to call out the whole weekend which I will not be paid for even though my job forced me to be vaccinated or be fired. Today will make it my fourth day since I been vaccinated and I am still in pain. My fingers also hurted. And also I was nauseous after I ate from Saturday to today.
35 2021-07-19 photosensitivity reaction, extreme sound sensitivity Two days after receiving the second vaccine, I experienced, what I'm assuming to be a migraine. I fe... Read more
Two days after receiving the second vaccine, I experienced, what I'm assuming to be a migraine. I felt light-headed and dizzy I had sensitivity to light and sound. The pain started above and around my left eye and then progressed down my cheek and I also had numbness going from around my eye down my left cheek. The migraine lasted from about Monday until Wednesday.
35 2021-07-22 loss of smell, loss of taste fever; chills; migraine; night sweats; diarrhea; loss of taste; loss of smell; This is a spontaneous... Read more
fever; chills; migraine; night sweats; diarrhea; loss of taste; loss of smell; This is a spontaneous report from a contactable other healthcare professional, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 21Mar2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic pelvic pain, depression, anxiety, pudendal nerve neuralgia, endometriosis, and Factor V Leiden. The patient previously received prednisone (MANUFACTURER UNKNOWN), LEVOQUIN and CIPRO and experienced drug allergy. Concomitant medications included lamotrigine (LAMICTAL), venlafaxine hydrochloride (EFFEXOR SR), ondansetron (ZOFRAN), topiramate (TOPAMAX) and levorphanol (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: unknown) via an unspecified route of administration in the left arm on 28Feb2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 02Apr2021 at 14:00, around a week and half after the patient experienced fever, chills, migraine and night sweats, diarrhoea, loss of taste and loss of smell. The night sweats were for approximately 3-4 days after vaccine. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, chills, migraine, night sweats, diarrhoea, loss of taste and loss of smell were resolving. No follow-up attempts are needed; information about lot number cannot be obtained.
35 2021-07-25 loss of smell, loss of smell Presented to ED on 7/24/21 for fever. Notes indicate Sx onset 7/18/21 felt shaky, sweaty, body aches... Read more
Presented to ED on 7/24/21 for fever. Notes indicate Sx onset 7/18/21 felt shaky, sweaty, body aches, chills & nausea. Lost sense of smell on 7/24.
35 2021-07-25 taste disorder Weird taste in the throat, chills, headache. Almost felt like I was anxious for the first two hours ... Read more
Weird taste in the throat, chills, headache. Almost felt like I was anxious for the first two hours then it went away. The night i felt chills, fever, slight cough and then it went away by sunday.
35 2021-07-27 eye swelling she had blisters in her mouth and around her mouth; her eyes were swollen; This is a spontaneous rep... Read more
she had blisters in her mouth and around her mouth; her eyes were swollen; This is a spontaneous report from a contactable Pharmacist. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date (age at vaccination 35-year-old) as dose 1, single for covid-19 immunization. The patients medical history and concomitant medications were not reported. One day after vaccination patient experienced blisters in her mouth and around her mouth and her eyes were swollen. Treatment included for adverse event eye swelling was steroid drops. The outcome of event was recovered on an unspecified date. Information about lot/batch number has been requested.
35 2021-07-27 ringing in ears, ear pain Recurrent ear pain- drainage-brain fog-severe headaches - numbness in fingers - ringing in ears - li... Read more
Recurrent ear pain- drainage-brain fog-severe headaches - numbness in fingers - ringing in ears - light headedness
35 2021-07-28 mouth tingling, swollen tongue Tongue tingling and swelling; Tongue tingling and swelling; Immediate headache; Tingling in arms/han... Read more
Tongue tingling and swelling; Tongue tingling and swelling; Immediate headache; Tingling in arms/hands; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8730) via an unspecified route of administration in the arm right on 05Apr2021 at 10:00 (at the age of 35-years-old) as a single dose for COVID-19 immunization. The patient had no known allergies to medications, food or other products. Concomitant medications included sambucus nigra (ELDERBERRY), multivitamins, paracetamol (TYLENOL), birth control (unspecified); all from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced immediate headache and tingling in arms/hands on 05Apr2021,at 10:00 and tongue tingling and swelling on 05Apr2021,at 10:30. Details were as follows: on 05Apr2021 at 10:00, the patient experienced immediate headache, within 2 minutes, tingling in arms/hands, which subsided and returned throughout the day, also within 30 minutes, the patient had tongue tingling and swelling. At 24h mark, tongue was still slightly tingly and slightly swollen but had subsided some. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. The clinical outcomes of immediate headache, tingling in arms/hands and tongue tingling and swelling were recovering. No follow-up attempts are needed. No further information is expected.
35 2021-07-28 feeling of choking, eye strain SHE HAD NUMBNESS AND TINGLING IN THROAT, HEAD, FACE, ARM. LIGHTHEADEDNESS, MILD CHEST PAIN. she had... Read more
SHE HAD NUMBNESS AND TINGLING IN THROAT, HEAD, FACE, ARM. LIGHTHEADEDNESS, MILD CHEST PAIN. she had heaviness in her eyes and arm . This was all starting about 15 min after receiving the vaccine
35 2021-07-28 vision blurred, taste disorder, loss of taste, double vision Event happened within week after 2nd dose of COVID vaccine -January 22 2021: loss of taste - start... Read more
Event happened within week after 2nd dose of COVID vaccine -January 22 2021: loss of taste - started after eating something spicy but remained for days; foods were tasting very bland -- > COVID test negative; also had already been vaccinated -- > acupuncture and then sx seemed to slowly resolve, and it is back to normal -January 27 2021: double and blurred vision - having trouble seeing computer and driving; improved with closing one eye -- > evaluated by Dr. in neuro-ophthalmology Feb 1 2021 and found to have RIGHT optic atrophy, in addition to LEFT exotropia in right gaze (LEFT INO causing adduction deficit) -- > MRI brain (Feb 1 2021) and C/T spine (Feb 12 2021) with multiple non-enhancing lesions c/w demyelination; RIGHT optic nerve thickening -- > blood tests with +ANA, elevated anti-dsDNA (rheum did not think patient had SLE) -- > CSF studies not done -- > sx now resolved without steroids (only lasted 3 days); There was measurable improvement on her follow-up exam with Dr. on February 12, 2021
36 2021-01-04 bloodshot eyes Left Red eye; Sore right arm; This is a spontaneous report from a contactable nurse. This 36-year-ol... Read more
Left Red eye; Sore right arm; This is a spontaneous report from a contactable nurse. This 36-year-old female nurse reported for herself that a 36-years-old female patient started to receive bnt162b2 (BNT162B2; Brand: Pfizer; Dose number: 1), intramuscular on 24Dec2020 15:45 at SINGLE DOSE at Vaccine location of Right arm for covid-19 immunisation. Patient was not Pregnant at the time of vaccination. Medical history included Graves disease. Patient had none Known allergies. The patient had no Allergies to medications, food, or other products. Concomitant medication included spironolactone (ALDACTONE), methimazole (METHIMAZOLE) within 2 weeks of vaccination. The patient experienced left red eye and sore right arm, both on 25Dec2020 with outcome of not recovered. No treatment received. The events reported as non-serious. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient hasn't been tested for COVID-19. Information on the lot/batch number has been requested.
36 2021-01-04 swollen tongue PATIENT HAD INJECTION AND HAD NO PROBLEMS WAS RELEASED THEN RETURNED WITHIN 30 MINS STATING SHE FELT... Read more
PATIENT HAD INJECTION AND HAD NO PROBLEMS WAS RELEASED THEN RETURNED WITHIN 30 MINS STATING SHE FELT LIKE HER TONGUE WAS SWELLING. PATIENT WAS REASSESED AND OBSERVED FOR ADDITIONAL 15 MINS AND STATES FEELS FINE. PATIENT RELEASED AGAIN.
36 2021-01-04 swollen tongue At 8:20 AM she complained of tongue swelling, Facial Flushing, BP went up 174/112, Pulse 123, Used a... Read more
At 8:20 AM she complained of tongue swelling, Facial Flushing, BP went up 174/112, Pulse 123, Used albuterol inhaler, Benadryl 50 MG PO, Vitals Signs gradually returned to normal BP on discharge 122/87, Discharged to coworkers at 9AM.
36 2021-01-05 loss of taste, sensitivity to light On 1/6 at approximately 9am hour, I noticed joint pain in my fingers while typing, muscle soreness i... Read more
On 1/6 at approximately 9am hour, I noticed joint pain in my fingers while typing, muscle soreness in my upper back, a headache, and a slightly sore throat. It quickly went down hill with a fever, chills, worsening joint and muscle pain everywhere, nausea, severe fatigue, worsening sore throat, tingling and numbness in all extremities at random locations. It is now 3pm, about 21 hours since vaccination-fever has broken once (I took ibuprofen at 2pm) but returned but not as high, and severe headache with light sensitivity. The joint pain and numbness has faded but I am left with severe muscle soreness, like I was in a car accident. Oh and I lost taste sometime today. Also I had injection site pain for both doses, starting the morning after.
36 2021-01-05 eye twitching Facial hives: resolved with PO Benadryl Right eye/cheek muscle twitching (ongoing for 1 week and c... Read more
Facial hives: resolved with PO Benadryl Right eye/cheek muscle twitching (ongoing for 1 week and continuously occurring).
36 2021-01-05 eye twitching Developed twitching of Left eye on 12/20/20 which continues to 1/4/21
36 2021-01-05 eye twitching Pt developed a twitching Left eye on 12/20/20 which continues on 1/4/21
36 2021-01-05 lacrimation increased I have body ache; clear nasal drainage; Nasal congestion; headache; moist cough; sneezing; watery ey... Read more
I have body ache; clear nasal drainage; Nasal congestion; headache; moist cough; sneezing; watery eyes; sore throat; This is a spontaneous report from a contactable nurse (patient herself). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (left arm), on 29Dec2020 at 15:15, at a single dose, for COVID-19 immunization. Relevant medical history included fibromyalgia. The patient has no known allergies. Concomitant medications included an unspecified multivitamin, cyclobenzaprine, methylphenidate, sertraline and ibuprofen. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID prior vaccination. The vaccine was administered in a nursing home/senior living facility. On 01Jan2021, at 8:00 a.m., the patient experienced body ache, clear nasal drainage, nasal congestion, headache, moist cough, sneezing, watery eyes, and sore throat. The patient did not receive treatment for the events. The patient has not yet recovered from the events. The patient had a negative post vaccination polymerase chain reaction (PCR)/ nasal swab on 02Jan2021. Information on the lot/batch number has been requested.
36 2021-01-05 visual impairment I suffered an ocular migraine 5 days post vaccine. Never had one before. Very scary. Zigzag spot in ... Read more
I suffered an ocular migraine 5 days post vaccine. Never had one before. Very scary. Zigzag spot in both fields of visions for 10 minutes followed by kaleidoscope vision in the left field for 5 mins. No headache after.
36 2021-01-07 loss of smell, loss of taste 12/23/2020 I started expecting the congestion on 12/25/2020 I lost taste and smell & I felt out of ... Read more
12/23/2020 I started expecting the congestion on 12/25/2020 I lost taste and smell & I felt out of breath and also had diarrhea. 12/26/2020 a doctor called me I express my symptoms he ordered a test for covid & I tested positive. On Saturday 01/02/2020 visited the ER to get help to breath
36 2021-01-07 ear discomfort moderately itchy rash on chest and burning ears about 1 hour after the vaccine. progressed to mild d... Read more
moderately itchy rash on chest and burning ears about 1 hour after the vaccine. progressed to mild diffuse itching which slowly subsided over the few hours; moderately itchy rash on chest and burning ears about 1 hour after the vaccine. progressed to mild diffuse itching which slowly subsided over the few hours; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231) on 05Jan2021 06:15 PM, Intramuscularly at single dose (vaccine location: Left arm) (first dose) for COVID-19 immunization. Medical history included cellulitis of lips due to use of 5 fu (stopped 1 week prior) for actinic keratosis. Concomitant medications included sulfamethoxazole, trimethoprim (BACTRIM) from 05Jan2021; amoxicillin, clavulanic acid (AUGMENTIN) from 05Jan2021; bupropion hydrochloride (WELLBUTRIN); escitalopram oxalate (LEXAPRO); magnesium; famotidine (PEPCID); ergocalciferol (VIT D); ascorbic acid (VIT C). There were no Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient experienced moderately itchy rash on chest and burning ears about 1 hour after the vaccine on 05Jan2021 07:30 PM, progressed to mild diffuse itching which slowly subsided over the few hours. Patient did not receive any treatment. The outcome of the events was recovering. This case was assessed non-serious by reporter. The events did not result in Death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
36 2021-01-07 mouth numbness numbness to lips day after vaccine tingling and numbness to left arm, progressively getting worse no... Read more
numbness to lips day after vaccine tingling and numbness to left arm, progressively getting worse no drooping to face hives injection site pain
36 2021-01-07 lacrimation increased, dry throat Patient started having severe dizziness, with a racing pulse. Pt stated she felt very warm. Given ... Read more
Patient started having severe dizziness, with a racing pulse. Pt stated she felt very warm. Given ice pack and cold cloths. BP was slightly elevated. Pulse initially was about 112. Had patient lay down and she felt better. Thought to be vasovagal response. Starting at 01:30 on 1/7/21 she had a severe headaches, eyes watering, runny nose, dry throat. Injection site reaction
36 2021-01-07 lip itchiness, sensitivity to light, mouth discomfort vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; ... Read more
vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; It appears I have eye shadow; peeling/dryness of skin around lips; peeling/dryness of skin around lips/It appears I have eye shadow but peeling is not visible; burning and itch of lip region; burning and itch of lip region; muscle spasm; Neuralgia; medium-severe headache; nausea; sensitive to light; mild confusion; lack of concentration; This is a spontaneous report from a contactable nurse (patient herself). A 36-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular in 28Dec2020 08:30 at a single dose in the left arm as COVID vaccine. Medical history included history of Grave's disease at age 19 which has resolved without medication for many years. The patient had no known allergies: no allergies to medications, food, or other products. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient had no other vaccine in four weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not taking any daily medications. On 28Dec2020 (day 1), patient had no significant symptoms. On 29Dec2020 (day 2), patient had medium-severe headache, nausea, sensitive to light, mild confusion and lack of concentration. On 30Dec2020 (day 3), patient had muscle spasm that wake from a sound sleep in biceps tendon region, and neuralgia in left upper and lower extremities. On 31Dec2020 (day 4), patient had peeling/dryness of skin around lips, burning and itch of lip region. On 01Jan2021 (day 5), patient had post vaccination burning, itching redness to eye lids. Patient realized patient should photo her journey. It appeared patient have eye shadow but peeling was not visible due to moisturizer and bacitracin "ito" try and sooth the pain. Patient can send at additional request since patient can't upload. The patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of the event "peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible". No treatment received in response to the other events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events medium-severe headache, nausea, sensitive to light, mild confusion, lack of concentration, muscle spasm, neuralgia in left upper and lower extremities, dryness of skin around lips, "peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible", burning and itch of lip region, post vaccination burning, itching redness to eye lids, and "it appeared patient have eye shadow" was not recovered. Information on the lot/ batch number has been requested.
36 2021-01-07 mouth discomfort Tingling/Hot burning throat/tachycardia and chest tightness. Presented to ED. Given diphenhydramine... Read more
Tingling/Hot burning throat/tachycardia and chest tightness. Presented to ED. Given diphenhydramine. Observed and discharged.
36 2021-01-08 mouth numbness 25 minutes after receiving vaccination ascending numbness of left half of tongue (ipsilateral to loc... Read more
25 minutes after receiving vaccination ascending numbness of left half of tongue (ipsilateral to location of vaccination site) with associated moderate headache. No tongue swelling or weakness. No breathing difficulty. This was followed by left arm numbness and mild left leg numbness. Left-sided paresthesias /numbness resolved within 3 hours of vaccination. The severity was mild-moderate without there ever being complete loss of sensation. No vision problems or weakness.
36 2021-01-08 mouth tingling Fever and chills starting 5 hours after dose, joint pain, myalgia, anxiety, palpitations, loss of ap... Read more
Fever and chills starting 5 hours after dose, joint pain, myalgia, anxiety, palpitations, loss of appetite, fatigue, abdominal pain, dizziness, near syncope, headache, insomnia, arm soreness, tingling and numbness in my face and mouth about 10 hours after dose and lasting about 30 min, taking ibuprofen one tablet q6 hours for fever and pain. 26 hours dose symptoms are improving
36 2021-01-08 swelling of eyelid Developed acute onset eyelid swelling, lip swelling, dyspnea with wheezing and hive like swelling at... Read more
Developed acute onset eyelid swelling, lip swelling, dyspnea with wheezing and hive like swelling at vaccine site. I self administered 8 puffs of albuterol (my prescription) and took 50 mg of oral Benadryl with improvement in wheezing and swelling at injection site. I continue with some mild unilateral right upper eyelid swelling but much improved.
36 2021-01-09 lip swelling Bell?s palsy the morning after the vaccination administration with left facial droop, left lip swell... Read more
Bell?s palsy the morning after the vaccination administration with left facial droop, left lip swelling
36 2021-01-09 ringing in ears, vision blurred Syncope at approximately 5:20am this morning. I had been awake and active for about 30 minutes getti... Read more
Syncope at approximately 5:20am this morning. I had been awake and active for about 30 minutes getting ready for work. As I was walking to my kitchen, I suddenly became very dizzy with blurred vision, tingling hands, nausea, ringing in my ears, and I felt like I was going to lose control of my bowels. I became very weak in the legs and I made it to the couch before I fell. Episode lasted approximately 2 minutes. As I laid down, my symptoms recovered. My husband gave me some juice and toast. After about 20 minutes, I got up and was able to walk without symptoms. I felt perfectly normal prior to this event. Last night, I ate a full dinner and drank about a liter of water. This event did not seem to be precipitated by hypoglycemia or dehydration. For the rest of this day, I have felt normal.
36 2021-01-10 ear pain Stiff neck like symptoms; including pain/aches in neck, radiating to back of ear/inner ear, dull thr... Read more
Stiff neck like symptoms; including pain/aches in neck, radiating to back of ear/inner ear, dull throbbing in jaw, pain in shoulder blade/back area towards left side--all of these symptoms progressively worsened and it is currently day 5 and still in a lot of pain, facial numbness/tingling for first two days on left side.
36 2021-01-10 eye pain Chills, body aches, fatigue, lower back pain, eye pain. No treatment with minor improvement
36 2021-01-10 eye pain Chills, body aches, fatigue, lower back pain, and eye pain. No treatment. minor improvement will c... Read more
Chills, body aches, fatigue, lower back pain, and eye pain. No treatment. minor improvement will continue to monitor
36 2021-01-10 mouth numbness Had palpitations while I was sleeping that woke me up. Had numbness to right and left arms. Later th... Read more
Had palpitations while I was sleeping that woke me up. Had numbness to right and left arms. Later that morning around 1130 had palpitations, dizziness, lightheaded ness that would not go away even when sitting down. I felt numbness around my mouth took blood pressure and it was elevated 200 systolic and 100 systolic called EMS they assessed my blood pressure but it was normal systolic 130?s which is hi for me Norma blood pressure for me 90-100 systolic
36 2021-01-10 mouth tingling tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt st... Read more
tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/Her tongue felt strange; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/felt hard to swallow; hot flash; flush feeling all over her face/flush all over her face/she felt flush; arm was sore; arm was sore and heavy; drowsiness; pain and redness at injection site; pain and redness at injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 36-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not provided) on 23Dec2020 09:15 intramuscularly in the left arm for COVID-19 immunisation (reported as preventive). There was no relevant medical history and no concomitant medications. The nurse (patient) received her first dose of the vaccine on 23Dec2020 at the hospital that she worked at. She was kept there for 15 min for monitoring and she felt fine. About 30 minutes post vaccination she got a hot flash, a flush over her face, she does not know if she was red but she felt flush. Her tongue felt strange, nothing swelled that she could tell, it felt hard to swallow, to make the motion to swallow it felt kind of sluggish. She felt weird swallowing which lasted for only a few minutes. She never struggled to breathe. She went back to park in the hospital parking lot since she was not sure if she was experiencing a anaphylactic reaction and then after a few minutes it went away. Her arm was sore and heavy feeling for that day. She had drowsiness for a couple of hours and pain and redness at the injection site for a couple of days that was not bothersome, it was mild. No relevant test. She wanted to know if she should get the second dose of the vaccine due to the symptoms she had after the first dose. The pain and redness at injection site was resolved on an unspecified date in Dec2020, while the other events were resolved on 23Dec2020. The reporting nurse considered the events hot flash, flush all over her face, arm was sore and heavy, drowsiness, pain and redness at injection site were non-serious, while the events "tongue felt strange, it was sluggish to swallow" were serious that she drove back to the hospital (no emergency room/phycian office visit). She considered the events were related to the vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162Bw on the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
36 2021-01-10 feeling of choking Pt is feeling well now had throat tingling, was given PO Benadryl 25mg observed additional 15 mins w... Read more
Pt is feeling well now had throat tingling, was given PO Benadryl 25mg observed additional 15 mins went back to unit
36 2021-01-10 sensitivity to light Patient reported, "I received my Covid 19 vaccination on Monday evening. I experienced a reaction im... Read more
Patient reported, "I received my Covid 19 vaccination on Monday evening. I experienced a reaction immediately following. Within 10 minutes I had tachycardia (130s), high BP (160s), lightheadedness, nausea, headache, and feeling like I was going to faint. I was attended to by Ambulance paramedics. At the time of her report to her primary care provider on 1/7/2021, she was still having pretty significant side effects (headache, dizziness, and light sensitivity), enough so that I was staying home from work. These symptoms have now resolved.
36 2021-01-11 dry mouth it was like having Covid again; it was like having Covid again; body aches; dry mouth; generalized w... Read more
it was like having Covid again; it was like having Covid again; body aches; dry mouth; generalized weakness; temp was 38.1 Celsius; head feels weird; can't sleep; decreased appetite; pain at the injection site; This is a spontaneous report from a contactable Nurse (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 from Mar2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced body aches, dry mouth, can't sleep, generalized weakness, decreased appetite, and pain at the injection site, temp was 38.1 Celsius, head feels weird in Jan2021. The patient got her first dose and was looking online to see the symptoms. She said that she saw that during the trials, people were experiencing the symptoms she was experiencing after the second dose and she was concerned. She said that she wanted to make sure her symptoms are ok and to make sure that the symptoms are not just caused from the booster, but also from the first dose. The caller said that her mom told her that someone died from the Pfizer vaccine. No further details provided. The patient was having body aches, could not sleep, her mouth is really dry, her temp was 38.1 Celsius, her head feels weird, she has generalized weakness, pain at the injection site, and decreased appetite. She said that it was like having Covid again. She said that she had Covid back in Mar2020. The patient underwent lab tests and procedures which included body temperature: 38.1 centigrade. The outcome of all the events was unknown. The events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the suspected COVID likely represents a pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test is needed for full medical assessment.
36 2021-01-11 extreme sound sensitivity, photosensitivity reaction around 14 hours past vaccine woke up with chills, low grade fever (100.8), severe calf pain and body... Read more
around 14 hours past vaccine woke up with chills, low grade fever (100.8), severe calf pain and body aches all over, and severe headache, around 3am had nausea to the point of needing zofran, chills continued until around 5am, body aches continued and was yelling, crying and tossing and turning, woke up at around 8am with 9/10 headache, light and sound sensitivity, alleviated some with coffee, extremely fatigued and weak (had trouble walking half a block), headache mostly gone by. 10am, fatigue continued throughout the day, NO appetite, intermittent chills. At bedtime ~9pm day 2 temperature 99.8. Slept through night. Sunday fatigue and excercise intolerance (typically exercise daily and am in good physical shape), had to sit down during walks with dog, Monday fatigue continued as did difficulty exercising long periods of time until afternoon, continued difficulty monitoring body temperature, getting cold really easily. Tuesday (today) continued weakness and exhausted but can't nap, no appetite. Never took anything except zofran 2x for nausea
36 2021-01-11 mouth tingling Patient received vaccine at 606 pm, began having reaction symptoms at 612 pm, reports symptoms as fe... Read more
Patient received vaccine at 606 pm, began having reaction symptoms at 612 pm, reports symptoms as feeling dizzy/lightheaded, also reports tingly lips. Patient stayed for observation for 30 minutes, once complete, reported still feeling slightly dizzy/lightheaded, but this is a normal reaction for her to vaccines per patient. Offered patient juice, and patient felt OK to leave, no medications given.
36 2021-01-11 sensitivity to light, eye swelling Received the second dose on 1/8- Felt tired with muscle aches and minor headache. Felt pain and sore... Read more
Received the second dose on 1/8- Felt tired with muscle aches and minor headache. Felt pain and soreness around injection site. On 1/9- had a severe migraine was unable to get out of bed due to migraine and extreme light sensitivity. Experienced severe muscle aches and chills. 1/10- started experiencing facial swelling especially of the left side. Extreme left eye swelling. With headache. Went to ER. Was given Benadryl to reduce swelling fluids and Prilosec for throat irritation. 1/11-started experiencing left arm numbness and tingling radiating down to fingertips. Experience left side facial numbness and tingling. 1/12- symptoms have begun to improve.
36 2021-01-11 vision blurred Headache, strong arm pain and redness at injection site, apart from these usual side-effects of the ... Read more
Headache, strong arm pain and redness at injection site, apart from these usual side-effects of the vaccine, she sees gray cloud-like vision, intermittently, usually gets worse during the afternoon.
36 2021-01-12 dry throat Headache, Myalgia, NauseaVomiting, Throat dryness, fatigue Narrative:
36 2021-01-12 ear swelling hives, ears red and swollen, itchy all over
36 2021-01-12 mouth numbness, eye itchiness Right outer lip numbness, itchy eyes. Improved with benadryl.
36 2021-01-12 sensitivity to light, eye pain Patient reports severe headache, vomiting and eye sensitivity to light and eye pain that lasted app... Read more
Patient reports severe headache, vomiting and eye sensitivity to light and eye pain that lasted approx 24 hours. 48 hours post injection Patient is complaining of significant muscle pain around her neck area.
36 2021-01-12 sensitivity to light light sensitivity; joint pain in my fingers while typing/worsening joint; muscle soreness in my uppe... Read more
light sensitivity; joint pain in my fingers while typing/worsening joint; muscle soreness in my upper back/worsening muscle pain everywhere; a headache; a slightly sore throat/worsening sore throat; a fever; chills; nausea; severe fatigue; tingling; numbness in all extremities at random locations; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), intramuscularly on 05Jan2021 at 18:30 on Left arm at single dose for COVID-19 immunization in hospital. None other vaccine received on same date. The patient medical history included Hypothyroid Generally healthy; Hx of depression and ADHD (Attention deficit hyperactivity disorder); and prior to vaccination, patient was diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE); ibuprofen; cetirizine hydrochloride (ZYRTEC). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly on 15Dec2020 at 18:30 on Left arm at single dose for COVID-19 immunization; and had known allergies with Sulfa and ciprofloxacin hydrochloride monohydrate (CIPRO) drugs, tramadol and oxycodone hydrochloride;oxycodone terephthalate;paracetamol (PERCOCET). The patient experienced on 06Jan2021 at approximately 9am hour, she noticed joint pain in her fingers while typing, muscle soreness in her upper back, a headache, and a slightly sore throat. It quickly went down hill with a fever, chills, worsening joint and muscle pain everywhere, nausea, severe fatigue, worsening sore throat, tingling and numbness in all extremities at random locations. Then at 3pm, about 21 hours since vaccination-fever had broken once but returned quickly, and severe headache with light sensitivity. The joint pain and numbness had faded but she was left with severe muscle soreness, like she was in a car accident. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event Muscle soreness was not recovered, outcome of the other events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
36 2021-01-12 ringing in ears, deafness hearing loss; ringing and pulsating in her ears; Chills; Headache; This is a spontaneous report from... Read more
hearing loss; ringing and pulsating in her ears; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration in in the left arm on 04Jan2021 at single dose for covid-19 immunization. Medical history included ongoing acid reflux. The patient had no concomitant medications. The patient previous received the flu shot. The patient experienced hearing loss, ringing and pulsating in her ears on 05Jan2021, headache on 04Jan2021, chills on 05Jan2021. Treatment was none. She had the vaccine on Monday at work and some of the symptoms that she has had have not resolved. She was having ringing in her ears and hearing loss. Went to see them and had her ears looked at. Everything was normal. Got the vaccine on 04Jan2021. Ringing in ears and hearing loss: Had been very consistent with no improvement. If anything, it had worsened. She was going to re-contact her doctor. She was also going to ask, should she go on Prednisone or something. She was worried she was going to lose her hearing. Her doctor said that a hearing test may need to be done. History: Takes one medication that she has been taking for years. She has never had an adverse event to any vaccine before. She got the flu shot every year. She was expecting the chills and headache, but they resolved fast. The next vaccine was 25Jan2021, the patient was asked whether she should get the second dose. The outcome of events for hearing loss, ringing and pulsating in her ears was not resolved, for headache and chills was resolved on 06Jan2021.
36 2021-01-13 loss of smell got the covid 19 vaccine on 21Dec2020 and tested positive for covid on 24Dec2020; got the covid 19 v... Read more
got the covid 19 vaccine on 21Dec2020 and tested positive for covid on 24Dec2020; got the covid 19 vaccine on 21Dec2020 and tested positive for covid on 24Dec2020; This is a spontaneous report from a contactable Nurse (patient) from a Pfizer-sponsored program Pfizer First Connect. A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via intramuscular in left deltoid on 21Dec2020 10:00 at 0.3 ml, single for precaution as front line healthcare worker in hospital which is not a military facility. Medical history included nonsmoker. She did not provide causality but stated that she probably already had COVID when she got the vaccine. It was unknown if the patient had SARS-CoV2 antibodies at diagnosis as she had never been tested. Other history was none. The patient did not have a history of hypertension, diabetes, heart disease, lung disease, liver disease, kidney disease, cancer, immunosuppressive disorder, obesity. There was not any pre-existing diseases worsened during the SARS-CoV2 infection. The patient hadn't been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Concomitant medication included bupropion hydrochloride (WELLBUTRIN SR), sertraline hydrochloride (ZOLOFT), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Prior Vaccinations (within 4 weeks) were none. AE following prior vaccinations were none. There was no additional vaccines administered on Same Date (21Dec2020) of the Pfizer bnt162b2. The patient got the covid 19 vaccine on 21Dec2020 and tested positive for covid on 24Dec2020. The patient wanted guidance on receiving the 2nd dose of the vaccine. The reporter considered event was non-serious. The patient received the first dose of the vaccine on 21Dec2020, and after that on 24Dec2020, she tested positive for COVID . She was supposed to be revaccinated on 07Jan2021. She would like to know if she should she get this or does she need to be revaccinated. There is no prescriber. She received it through her work. She received the first dose on 21Dec2020, and assumed she was positive when she got it. She just had cough and muscle aches and a headache. Her dad was hospitalized. Hers was not that serious. She had not completely recovered yet. Her smell had not come back yet and she was just tired still. She said the headache was prior to getting vaccine. She did not provide causality but stated that she probably already had COVID when she got the vaccine. The cough occurred on 25Dec2020, muscle aches on 22Dec2020 at 08:00. There was no emergency room of or physician's office required for the events. The patient was not hospitalized or admitted to an ICU. Nasal swab test done. Imaging for COVID-Pneumonia, other radiological investigations, hematology, clinical chemistry, inflammatory markers, urinalysis, evidence of hypoxemia, other relevant test were none. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient did not receive any additional therapies for COVID-19. The event did not require the initiation of new medication or other treatment or procedure. She did start taking extra vitamins on her own. The patient was recovered with some lasting effects such as not being able to smell and is tired still.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID with symptoms and the administration of COVID 19 vaccine, bnt162b2. However, as the reporter claimed "she probably already had COVID when she got the vaccine", this may provide an alternative explanation.
36 2021-01-13 mouth tingling Tingling to top lip, urticaria which was systemic
36 2021-01-13 mouth tingling Employee had same reaction as Dose # 1 despite pre-medicating with Benadryl and having a consult wit... Read more
Employee had same reaction as Dose # 1 despite pre-medicating with Benadryl and having a consult with an Allergist. Dizziness, Lightheaded, Tongue and Facial Tingling
36 2021-01-13 visual impairment After first vaccine i experienced fatigue, body aches, headache and nausea for 2 days and injection ... Read more
After first vaccine i experienced fatigue, body aches, headache and nausea for 2 days and injection site pain for two weeks. After second Vaccine given at 9:55am. tingling of feet for about 20 mins, 30 mins after the vaccine. Two hours later fatigue, body aches, headache and nausea began. At 0030 1/12/2021 I woke up with severe chills and left chest pain, temp was 101.6 and heart rate was 160. I began to see black and chest pain was severe feeling like i was having a heart atack and was going to pass out so i called 911. I then began to get short of breath and got numbess on my legs, left arm and left side of neck. Chest pressure/pain radiated to left arm and neck. I was taken by the ambulance to hospital. Arrived around 0130. My heart rate sustained at 140s in the ER so I was admitted at 0530 am. My D Dimer was a bit elevated as well as my lactic so I was given a bolus of fluids plus maintenance. I had a CXR done, CTA chest(negative for PE), UA, Labs, entire cardiac workup including an ECHO during my admission. I also began to have loose stools and wrist joint pain. MY heart rate sustained at 125-147 for about 30 hours. Fevers on and off. After everthing was negative we determined this was secondary to the covid 19 vaccine. I was discharged 1/13/2021 at around 1:30 pm. My heart rate is still not at baseline which is 87-90. I'm 100-130 and still get very fatigued with a simple slow walking. Still having tachycardia, fevers, body aches, joint wrist pain, chest discomfort and headaches. My potassium was 3.0 at discharge so will be needing labs in a week. Also bruised a little different than I usually do with lab draws so keeping an eye on them and will be checking my platelets again in a week. Ive been taking tylenol for my fever and pain and ativan for any anxiety when my heart rate goes up. (treatment during hospital stay was normal saline bolus, nomal saline maintenance fluids at 150 cc/hr, tylenol, ativan, ice packs, rest)
36 2021-01-15 taste impairment Severe chills Fever 102.8 Body aches Fatigue Headache Metallic taste for days
36 2021-01-17 deafness Friday Jan 15th - arm pain. Saturday Jan 16th - fever of 99.5, chills, no appetite, dehyrdration, sw... Read more
Friday Jan 15th - arm pain. Saturday Jan 16th - fever of 99.5, chills, no appetite, dehyrdration, swelling and redness around injection site, progressed throughout day. Sunday Jan 17th - further swelling and arm pain, lymphnods in underarm area painful and swollen, bruising Monday Jan 18th - Swelling and redness size of palm, warm to touch, painful, itchy
36 2021-01-17 mouth tingling Slight left sided facial weakness/droop 4 days post vaccination; Slight left sided facial weakness/d... Read more
Slight left sided facial weakness/droop 4 days post vaccination; Slight left sided facial weakness/droop 4 days post vaccination; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination/Tingling to lower extremities; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination; This is a spontaneous report from a contactable consumer (patient herself). A 36-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EK9231), via an unspecified route of administration in the left arm on 04Jan2021 13:00 at single dose, for Covid-19 immunisation. The vaccine was given in a Nursing Home/Senior Living Facility. Medical history was none. No known drug allergies. No other vaccine in four weeks. No Covid-19 prior vaccination. Concomitant medication included naproxen sodium (ALEVE). The patient experienced tingling in injected arm and facial tingling in cheeks/lips same day of vaccination (04Jan2021). Tingling to lower extremities the day after vaccination (still continuing). Slight left sided facial weakness/droop 4 days post vaccination (04Jan2021). Tingling to left arm continuing on and off. No treatment reported. On 04Jan2021, she was negative to PCR covid test post vaccination. She went to the Emergency room/department or urgent care. The outcome of events was not recovered.
36 2021-01-17 enlarged tonsils Tonsillar and occipital Lymph node moderate swelling. Difficulty Swallowing. Stiffness in head and n... Read more
Tonsillar and occipital Lymph node moderate swelling. Difficulty Swallowing. Stiffness in head and neck. Profound fatigue. methylprednisoLONE (Medrol, Pak,) 4 mg tablet and azithromycin (Zithromax Z-Pak) 250 MG tablet mono test negative After 5 days on medications nodes size reduced, tenderness, stiffness, fatigue remain, but overall improved.
36 2021-01-18 eye twitching Approximately 15 minutes after vaccine injection, right upper eyelid started spasming. This has happ... Read more
Approximately 15 minutes after vaccine injection, right upper eyelid started spasming. This has happened approximately 15-20 times every day, for the last 9 days. Never had this before.
36 2021-01-18 oropharyngeal discomfort Pre-dosed benedryl 25mg po at 7:00am, due to the previous reaction to covid vaccine number 1, where ... Read more
Pre-dosed benedryl 25mg po at 7:00am, due to the previous reaction to covid vaccine number 1, where she stated she developed hives. Received second vaccine dose at 07:30. Around 7:45 co itchiness, no hives. At 0800, throat itchy, c/o not feeling well, dizzy, b/p144/96, hr88. taken to ER.
36 2021-01-18 mouth tingling 5 minutes after the injection she started to get tingling lips and tingling in the top of her tongue... Read more
5 minutes after the injection she started to get tingling lips and tingling in the top of her tongue. It lasted several hours and resolves spontaneously. 2 hours after the vaccine she also started to get some severe heart palpitations episodes, each one lasting no more than 15 minutes, and total of several episodes, the whole of which went on for no more than 2 hours. no abdominal pain or diarrhea. no rashes, no SOB, no cough, didnt feels like her throat closed up.
36 2021-01-18 mouth tingling 5 minutes after the injection she started to get tingling lips and tingling in the tip of her tongue... Read more
5 minutes after the injection she started to get tingling lips and tingling in the tip of her tongue. It lasted several hours and resolved spontaneously. several hours after the vaccine she started to get episodes of 15 minute bursts of severe palpitations, lasting total 2 hours, also eventually resolved spontaneously.
36 2021-01-19 mouth numbness Symptoms include flushed/itchy face, red patches on face, numb tongue, no fever
36 2021-01-20 eye pain Shoulder pain; Body hurting; Headache; Area around my neck hurts really "bad"; My eye hurts; This is... Read more
Shoulder pain; Body hurting; Headache; Area around my neck hurts really "bad"; My eye hurts; This is a spontaneous report from a contactable consumer (a Certified Nurse Assistant) reporting for herself. A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 at 07:30 at single dose for covid-19 immunisation. Medical history and concomitant medication were none. Patient received the vaccine on 07Jan2021 at around 7:30 in the morning. On an unspecified date in Jan2021, she started developing like really bad shoulder pain and like her body was hurting, and she had like a severe headache and area around her neck hurt really 'bad' (not clarified). She had been taking Tylenol but did not work, nothing seemed improving and what else she could can take for it. Patient stated it was really bad. It didn't even help that much but she was taking. Patient further added she was taking '550 mg' (not clarified) per tablet and it was not working. When probed if still having the problems the patient stated they was just getting worst, and her eye hurt too (Jan2021). Final outcome of the events was reported as not recovered. Second dose of the vaccine was scheduled on 28Jan2021. Information on the Lot/Batch number has been requested.
36 2021-01-20 oropharyngeal discomfort, mouth numbness Tongue numbness then throat tingling She had premedicated with Benadryl oral 25 mg. Additional do... Read more
Tongue numbness then throat tingling She had premedicated with Benadryl oral 25 mg. Additional dose of Benadryl 50mg IM given observed one hour and began to have reappearance of symptoms. Epi 0.3 mg given.
36 2021-01-20 mouth tingling patient received BNT162B2/ breastfeeding; patient received BNT162B2/ breastfeeding; Right away very ... Read more
patient received BNT162B2/ breastfeeding; patient received BNT162B2/ breastfeeding; Right away very strong jaw tightness with lightheadedness/muscles feel so tight; Right away very strong jaw tightness with lightheadedness; the tight jaw with Very tight full deep ache all over body/whole body hurts/feeling more pain; Headache lasting over 59 hours; Very very fatigued/feeling more fatigue; Chills worse at night; her hands feel swollen and cramping but they do not look swollen; her hands feel swollen and cramping but they do not look swollen; On and off lip/face tingling; On and off lip/face tingling; she felt like her lymph nodes were swollen; shaking; This is a spontaneous report from a contactable nurse (reported for herself). This nurse reported information for both mother and baby. This is the maternal report. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ec1284), via an unspecified route of administration on 11Jan2021 10:00 at a single dose on left arm for COVID-19 immunization. Medical history included low vitamin d and patient is currently breastfeeding. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid, calcium, colecalciferol, cyanocobalamin, folic acid, iron, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, zinc (PRENATAL S), vitamin d [vitamin d nos] (VITAMIN D), and calcium. The patient was administered with first dose of bnt162b2 (Pfizer brand) on 21Dec2020 at 10:00 on her left arm (lot number: EJ1685) for COVID-19 immunization. No any other vaccines within 4 weeks prior to the COVID vaccine. On 11Jan2021 10:15, the patient experienced right away, very strong jaw tightness with lightheadedness. The lightheadedness feeling improved 2 hours later, but the tight jaw with very tight full deep ache all over her body. She had headache lasting over 59 hours. Her whole body hurt. Her muscles felt so tight and she was "very very" fatigued. She had chills (worse at night). She was shaking both nights after 2nd vaccine. Her hands felt swollen and cramping, but they did not look swollen. She also had on and off lip/face tingling. She felt like her lymph nodes were swollen. She can't even do a load of laundry without feeling more pain and fatigue. It was unknown if treatment was given for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious. The patient was not hospitalized due to the events. The patient has not recovered from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021038485 baby case
36 2021-01-21 loss of taste, loss of smell After my second vaccine on 1/12 at approximately 0730am I developed fever and chills around 1100pm t... Read more
After my second vaccine on 1/12 at approximately 0730am I developed fever and chills around 1100pm that same day. I had these symptoms through 0800am on 1/13. I was recovered from these symptoms on 1/14. However, by the evening of 1/15 I developed some sinus-related symptoms like sneezing and runny nose. On 1/16 I could not taste or smell anything. I got a PCR COVID test on 1/17 and have not developed any additional symptoms. My sinus related symptoms resolved after 1/17. As of today, 1/22, my PCR results have come back positive.
36 2021-01-21 mouth numbness, mouth tingling I received the Covid-19 vaccine on 01/20/2021 and had tingling/slight numbness in my left arm (injec... Read more
I received the Covid-19 vaccine on 01/20/2021 and had tingling/slight numbness in my left arm (injection arm). Later in the evening I had the same feeling in my left leg and in my cheeks, lips, tongue and teeth. I felt like I had been numbed at the dentist, but was coming out of the numbness. It was like when the numbness is mostly gone and you're left with that tingling sensation, and your face feels puffy. It was basically that feeling in my face, left leg, and left arm. Those sensations are mostly gone today (the second day following), but not quite.
36 2021-01-21 mouth numbness Numbness of the right half of her tongue
36 2021-01-21 mouth numbness Immediately after shot felt a very slight numbing on right side of tongue - almost like numbing gel ... Read more
Immediately after shot felt a very slight numbing on right side of tongue - almost like numbing gel dentist uses. Half hour later I can feel this same numbing feeling all over my mouth.
36 2021-01-21 mouth tingling Chills, Nausea, Body aches, Lip Tingling
36 2021-01-21 swollen tongue Pt received first Covid Pfizer vaccine this evening and during 15 minute wait time experienced left ... Read more
Pt received first Covid Pfizer vaccine this evening and during 15 minute wait time experienced left arm swelling, tingling and discomfort. Pt alert, oriented and denies any respiratory symptoms. Gave Benadryl 25 mg po at 1758 and pt states "50 mg makes me tired and I live out of town". Gave second dose of Benadryl 25 mg po at 1800 when pt began feeling "like my tongue is swelling". Contacted Med ER team to assist with monitoring. Removed pt rings and bracelets on left wrist/hand as pt states "feel like my whole arm is swelling". BP: 122/78 Rt. Arm with apical HR: 60/min and regular. Injection site Left deltoid is not red but swelling noted and spreading. Area is normal temp to touch. Tried ice bag to injection site left deltoid which made it feel worse per pt. The ice made the arm area red. 1818 BP: 136/90. Med team arrived and decision made to transport pt to ED for observation. Pt assisted to wheelchair for transport. Report given to RN from ED. Pt remained alert and oriented throughout. Pt contacted her family herself to notify. Pt received Solumedrol and Famotidine in the ED. Pt was observed and discharged within an hour. Pt follow up with Employee Health provider 1/22/21. Pt continues to experience intermittent rash/hives on chest/neck relieved by Benadryl, Headache, and entire left side feeling tingling and "weird".
36 2021-01-22 eye itchiness, eye swelling Patient called after receiving vaccine stating her eyes were swollen and itchy. Said her eyes were n... Read more
Patient called after receiving vaccine stating her eyes were swollen and itchy. Said her eyes were not swollen shut. Denied: sore throat, shortness of breath, swelling of the tongue or lips. Advised to take Benadryl and seek medical attention if any of the other symptoms occurred or if she felt it necessary.
36 2021-01-23 swelling around the eyes Bilateral eye edema. Moderate swelling of the peri orbital areas
36 2021-01-24 pain in jaw, mouth tingling, mouth numbness At 0930 1-21-2021 at the site of her injection on her left deltoid her arm began to itch. Between 1... Read more
At 0930 1-21-2021 at the site of her injection on her left deltoid her arm began to itch. Between 1100-1130 the left side of her jaw began to hurt. She rates that pain 4-7/10. Five minutes later the left side of her lips began to tingle and became numb. She looked in the mirror and saw her face drooping. The Occupational Health Call Center advised her to go the ED. The ED physician told her she did not have Bell's Palsy due to the fact that her eyebrow and cheek were not involved. She was give Toradol and later took Benadryl at home. The ED physician reported to her she had a severe reaction and to monitor for symptoms.
36 2021-01-24 sensitivity to light, eye irritation, eye pain Day of vaccine: headache, sore arm. Day 2: migraine, eyes sore to touch, burning, extremely sensitiv... Read more
Day of vaccine: headache, sore arm. Day 2: migraine, eyes sore to touch, burning, extremely sensitive to light, dizzy, extremely tired. Day 3: headache, nausea, vomiting, diarrhea, dizzy, resting heat rate above 100, exhaustion. Day 4: shaky, dizzy, nauseous, resting heat rate not below 100 for several hours, heart palpitations, heart beating very hard at times, exhaustion.
36 2021-01-25 taste impairment Strong metallic taste in mouth; This is a spontaneous report received from a contactable nurse (who... Read more
Strong metallic taste in mouth; This is a spontaneous report received from a contactable nurse (who is also patient). A 36-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration in right arm, on 12Jan2021 11:00, at single dose, for COVID-19 immunization, in the hospital. There were no medical history and concomitant medications. The patient has no known allergies. The patient is not pregnant. The patient did not have COVID-19 prior to vaccination and did not receive other vaccines in four weeks. The patient experienced strong metallic taste in mouth on 12Jan2021 11:30. No treatment was given for the event. The patient was not tested for COVID-19 post vaccination. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.
36 2021-01-25 pain in jaw Right sided jaw to chest pain. Right sided chest pain was intermittent and became severe enough to g... Read more
Right sided jaw to chest pain. Right sided chest pain was intermittent and became severe enough to go into ER.
36 2021-01-25 swollen tongue Throat/tongue swelling initially. Took benadryl. Next day, I was very weak, in/off heachache. Mild... Read more
Throat/tongue swelling initially. Took benadryl. Next day, I was very weak, in/off heachache. Mild temperature. Today is day 6 and I'm still very weak, get light headed at times
36 2021-01-26 eye swelling swollen eyes and face(mildy)
36 2021-01-26 mouth numbness, mouth tingling Facial swelling; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, to... Read more
Facial swelling; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; This is a spontaneous report from a contactable other hcp (patient) reported that a 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284), via an unspecified route of administration on the left arm on 11Jan2021 13:00 at a single dose for Covid-19 immunization. Medical history included endometriosis, gastrooesophageal reflux disease (GERD) and liver lesion; all from an unknown date. Concomitant medications included fish oil (FISH OIL), omeprazole (PROTONIX [OMEPRAZOLE]) and sertraline hydrochloride (ZOLOFT); all were taken from an unspecified date for an unspecified indication. The patient previously took amantadine and experienced drug allergy. On 12Jan2021 03:00, the patient experienced facial swelling, and numbness and tingling of mouth, tongue and face. Therapeutic measures were taken as a result of facial swelling, numbness and tingling of mouth, tongue and face. The reported events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was not recovered.
36 2021-01-26 mouth discomfort, lip swelling, vision blurred Second day after vaccine had joint pain and chills third and 4 day stomachache. 1 week after started... Read more
Second day after vaccine had joint pain and chills third and 4 day stomachache. 1 week after started having neck pain on my left side until now and irradiate toarse my shoulder and arm p to my hand on left side also random days present dizziness when I lie down blurry vision. on January 19 had neck pain shoulder pain and headaches on left side too went to Dr. and his medical diagnosis was muscle spasm might be induce due to stress pre-scribe Diazepam 5 mg . start taking it on Wednesday January 20-2021 but Saturday January 23 my upper lip started getting swollen , IL STOP THE MEDICATION ON MONDAY JANUARY 27 LIPS got better but still filling burning sensation inside mucosa on left side of the lip. still mild swollen started taking Zyrtec my concern is second doses of Pfizer vaccine is this Friday 29 should I get it or wait ?? what I Have could be effects from first Dose??.
36 2021-01-27 double vision Immediately felt tightness in chest. Has continued on and off many times a day to this time. Continu... Read more
Immediately felt tightness in chest. Has continued on and off many times a day to this time. Continues now along with periods of difficulty breathing. Today upon waking tightness in chest felt intensified and continues now (evening). Midday experienced sudden vertigo and double vision lasting over a minute along with dizziness. I had already eaten lunch. Primary Dr ordered me to emergency room. Extensive testing along with chest x-ray and EKG performed. No abnormalities were found. ED doctor said a State test of some sort would tell us if it is an actual allergic reaction or an intensive immune response. He said it would take a few days for results. I was given diagnosis of vaccine reaction and sent home for rest. Advised to return if symptoms get worse. Tightness in chest continues at this time. Fatigue and headache have also returned.
36 2021-01-27 dry mouth Dizziness, sweating, chest heaviness, palpitations, headache, dry mouth, nausea, hypertension
36 2021-01-27 taste impairment, smell distorsion Felt lump in throat 2 minutes after receiving vaccine. 3 minutes later she felt chest pressure and h... Read more
Felt lump in throat 2 minutes after receiving vaccine. 3 minutes later she felt chest pressure and had a metallic taste in mouth and with smell. She was brought to TEC for futher evaluation.
36 2021-01-27 feeling of choking LEFT ARM NUMBNESS AND TINGLING THROAT FELT THICK BENADRYL 50MG IM GIVEN
36 2021-01-28 mouth tingling Directly after, bright red/ hot ears, itchy face, tingling face and lips Some hives later Severe hea... Read more
Directly after, bright red/ hot ears, itchy face, tingling face and lips Some hives later Severe headache and nausea the next day
36 2021-01-28 thirst feels tired; heart rate became very fast, it went into like the 150's; feeling jittery; Lightheadedn... Read more
feels tired; heart rate became very fast, it went into like the 150's; feeling jittery; Lightheadedness; weakness of lower extremities; Nauseated; felt really cold; probably had a fever; really thirsty; very hot; she wasn't feeling well; This is spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular (deltoid left) on 14Jan2021 18:25 at 0.3 mL, single for Covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took Bactrim and experienced allergy. The patient reported she did develop some side effects, but the hospital she received the vaccine at didn't know if it was an allergic reaction or what. She reported that a minute or two minutes after receiving the COVID-19 vaccine (14Jan2021), her heart rate became very fast, it went into like the 150's. She started feeling jittery, lightheaded, and she had some weakness of her lower extremities. She also felt nauseated. She didn't have any shortness of breath; she thinks she was okay there. She clarified that she had her mask on and they told her to remove her mask and to breathe, breathe, breathe. She had a pulse oximeter on, and her levels were always at 98, 96. She was told to sit still, and she was given water. Her heart rate went down to 76. She was fine and then after 5 minutes, she had the same reaction again. Her heart rate this time was in the 120's. She was lightheaded, cold, jittery. She did the same thing again and waited another 5- 10 minute. She felt better but was still nauseated, lightheaded, and really, really cold. She was kept there for 45 minutes. After that, she still did not feel 100%. Currently, she still does not feel 100% well. She was okay, she thinks she was okay. She explains they wanted to send her to the ER (emergency room) but she declined. Her heart rate had improved, she wasn't feeling like she was going to pass out. She wasn't experiencing shortness of breath, she wasn't throwing up, she didn't have a rash, her throat wasn't closing up, so she went back to work. She further stated that she came back home. Her heart rate was a little faster, but it wasn't as high as it had been. She still felt a little bit of weakness. At night (14Jan2021), she probably had a fever, she doesn't know. She was really thirsty and very hot. Because she was not feeling well, she didn't get up and drink anything. This morning (15Jan2021), she feels a little better. If she is doing her normal activities, she does get tired. She feels like she is running and is like "okay I feel tired". She has a little bit of weakness in her lower extremities. She was given information for reporting side effects, but because she wasn't feeling well, she didn't do any of it. She checked her heart rate today (15Jan2021) and it's at 76. She added that when she moves a lot, she feels tired and she doesn't know why. She's normally a very active person. She is no longer jittery, but still feels lightheaded. She has a little bit of nausea. She felt hungry so she made a shake and it's not like she is going to throw up, but she is still feeling yucky. She still has a little weakness of her lower extremities. They feel light, she doesn't know how to explain it. She is just a little bit concerned because this is a new vaccine. The outcome of event heart rate increased was recovering; outcome of event feeling jittery was recovered on an unspecified date; while the outcome of other events was unknown. The patient confirmed he doesn't believe it to be life threatening. She doesn't know if this is a severe allergic reaction. She was reading on the side effects the COVID-19 vaccine can cause. Per reporter all events were related to suspect product.; Sender's Comments: Based on the compatible time association, the contribution of suspect BNT162b2 to the event heart rate increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-01-31 dry throat feeling like I was 500 lbs; I felt like an impending sense of doom; swollen lymph nodes in my neck; ... Read more
feeling like I was 500 lbs; I felt like an impending sense of doom; swollen lymph nodes in my neck; stiff neck; severe shivering; I needed assistance to walk safely to avoid falling; Intense pain in my left arm; dryness in my throat/severely dry throat; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration in right arm on 23Dec2020 17:15 at single dose for COVID-19 immunization. Medical history included acid reflux from an unknown date and unknown if ongoing. There were no concomitant medications. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the first Pfizer vaccine on 23Dec2020 at approximately 5:15 PM. The patient felt fine until about 11 PM at night, the patient stated, "when I began experiencing intense pain in my left arm and dryness in my throat" on 23Dec2020. I took a Benadryl and went to bed. At approximately 1 AM (24Dec2020) I woke up feeling like I was 500 lbs (I am about 175 lbs). I also had swollen lymph nodes in my neck, a stiff neck, a severely dry throat, and severe shivering. I attempted to navigate to the bathroom and felt like I needed assistance to walk safely to avoid falling. I felt like an impending sense of doom, and called my mom who is a nurse. She told me to contact the Pfizer #, but nobody was answering the phone at that time. I then started looking up on the internet if anyone else had experience what I was feeling after the vaccine and if the feeling passed, as I was not sure if I should go to the ER. I ended up falling asleep." The outcome of the events was recovering. The patient took Benadryl for events "intense pain in my left arm and dryness in my throat" as treatment. No treatment was given to the patient from the remaining events. Information on the lot/batch number has been requested.
36 2021-01-31 vision blurred Dizzy, blur vision, HA observed 45mins. 1/13/21 6 lb weight gain. Hx of autoimmune dz.
36 2021-02-01 ear discomfort Facial flushing that was more prominent on the left side of my face and left ear flushing and burnin... Read more
Facial flushing that was more prominent on the left side of my face and left ear flushing and burning, dizziness, nausea., and rapid pounding heart beat. This started 45 minutes after receiving the vaccine. About 1 1/2 hours symptoms still persisted so took 50mg of Benadryl and slept for 2 hours. Upon waking up facial flushing, dizziness, and pounding heart rate still present but was better. Continued to have left sided cluster headache and face flushing for 48 hours. Also was sore in my left arm down my left side to the bottom of my rib cage all the way up my left neck and sore into my left chest.
36 2021-02-01 mouth numbness Tongue numbness
36 2021-02-01 mouth tingling STAYED EXTRA 15 MIN TINGLING MIDDLE OF TONGUE WHICH RESOLVED.
36 2021-02-01 mouth tingling Patient reported tingling lips, scratchy throat, and a mild headache although the headache had been ... Read more
Patient reported tingling lips, scratchy throat, and a mild headache although the headache had been off and on all day. No SOB nor difficulty breathing. Patient reported some chest tightness but felt this may be due to anxiety. No antidote nor supportive treatment given. Symptoms resolved within 30 minutes and patient stayed an additional 15min for observation
36 2021-02-01 swollen tongue, mouth swelling Vaccine administered by RN on 2/02/2021 at 11:50am. Location was at Nursing Home. Coordinating fac... Read more
Vaccine administered by RN on 2/02/2021 at 11:50am. Location was at Nursing Home. Coordinating facility for vaccines is the Health District. Within five minutes after vaccine administration, the patient's co-worker informed the patient that she had some redness on her neck. Patient left dining hall where vaccines were being administered and upon return, RN with HD asked patient how she was feeling. The patient was noted to have a red neck and chest with some petechiae on neck and chest. Patient c/o headeache and numb right arm, same arm used for vaccine. At 12pm, 25mg PO of Diphenhydramine was given by RN. The patient c/o nausea and started to vomit. HR was assessed by RN at a radial rate of 106 BPM. Patient stated her head was hurting worse and continued to vomit. RN, called EMS. Cold compress given to patient and patient was assisted to restroom by RN. Upon exiting the restroom, patient started vomiting again and stated her throat was itching and tongue felt swollen. She stated she was allergic to vanilla and her throat felt the same as when she reacts to vanilla. RN, attempted to visually inspect the patient's throat/tongue/mouth and noted that back of the mouth was edematous and unable to visually see the throat. 12:11 pm, 0.3 mg of epinephrine administed by EPIPEN into right lateral thigh. EMS arrived at 12:15pm. Patient assessed by EMS and agreed to transport to Hospital for evaluation. EMS and RN assisted patient to stretcher for transport. Nursing Supervisor, with Health District notified by phone by RN.
36 2021-02-02 dry mouth Chills, sweats, vertigo, joint pain (particularly in my knees) , muscle pain, extreme exhaustion, li... Read more
Chills, sweats, vertigo, joint pain (particularly in my knees) , muscle pain, extreme exhaustion, lightheadedness, swelling of my extremities, injection site soreness felt like my heart was beating irregularly, cotton mouth, decreased appetite, mental fog. These all started about 12 hours after vaccination and lasted for 2 whole days. Additionally, on Jan 31st, I experienced numerous occasions of "pins and needles" in my feet. This went away and came back over several hours of time throughout the day on Jan 31st. Exhaustion and mental fog have continued through 2/3, but all other symptoms have resolved.
36 2021-02-03 mouth tingling, swollen tongue fatigue swelling of the tongue tingling of tongue when drinking water fast heart beat headache
36 2021-02-04 mouth discomfort Patient reported throat itching ~30 minutes post-vaccination. Given cetirizine 10 mg orally x 1 dose... Read more
Patient reported throat itching ~30 minutes post-vaccination. Given cetirizine 10 mg orally x 1 dose. Itching/burning spread to oral mucosa (throat, roof of mouth), denies other symptoms. Given epinephrine 0.3 mg IM x 1, IV line started w/ NS at 125 mL/hour, diphenhydramine 50 mg IV x 1 dose all 5 minutes after cetirizine. EMS called, patient transported to ED for further evaluation.
36 2021-02-04 swelling around the eyes Cough- but the type of cough is not uncommon for me due to allergies Puffy eyes/face started around... Read more
Cough- but the type of cough is not uncommon for me due to allergies Puffy eyes/face started around 2:30-3pm Tight throat, felt restricted started around 3:30pm Took Benadryl at 4:30pm Went to Urgent Care at 5:30pm Took Prednisone at urgent care Got a prescription to continue prednisone for the next two days & an epi pen to have at home in case it was needed
36 2021-02-04 feeling of choking, tongue disorder Approximately one hour after the injection, patient reported difficulty swallowing, throat swelling/... Read more
Approximately one hour after the injection, patient reported difficulty swallowing, throat swelling/tingling, tongue thickness
36 2021-02-04 swollen tongue hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; diffi... Read more
hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; difficulty breathing (wheezing); difficulty breathing (wheezing); injection site soreness; She was hot, flush; difficulty swallowing; the tongue started swelling/Swollen tongue; Anaphylactic reaction/anaphylaxis; This is a spontaneous report from a contactable consumer reported for self. This 36-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 12:52 left arm at single dose (Lot: EL3247) for covid-19 immunisation. Medical history included ongoing Anaphylaxis to Walnuts, Oranges, and morphine, ongoing allergy to a steroid cream Kenalog, and a steroid powder which she broke out immediately and ongoing Colitis. Concomitant therapy was none. She received the first dose of the vaccine yesterday on 20Jan2021 12:52 and 10 minutes later (20Jan2021 13:02) the tongue started swelling/Swollen tongue so they gave her Benadryl to try to stop it but it didn't help enough, hives started to appear on her body so they gave her a dose of epinephrine in the right arm and put on an IV, because she was feeling nauseous and dizzy. She started to feel better and was transferred to the hospital, when she was in the hall of the hospital she started having difficulty breathing (wheezing) and difficulty swallowing so she received another dose of Epinephrine (EpiPen) and also Benadryl, Prednisone and Pepcid. She went home and was taking Prednisone (1 daily), Benadryl and salbutamol (twice daily). She went into anaphylaxis within 15 minutes of receiving it on 20Jan2021. She brought 2 Epi injections with her. They monitored at the hospital for a few hours. She knows exactly how it happened. She was sitting in the observation room. She had told them multiple times that she had allergies before. She came in with two Epi pens and Benadryl. She let them know that as well. She was very verbal that she has history of anaphylaxis. They gave it to her. They said they were going to monitor her for 30 minutes. Her tongue started to swell 10 minutes after. She was sent to the paramedic tent. She took liquid children's Benadryl to try to stop the reaction. It did not help. She clarified it just didn't work enough to delay it. She doesn't have UPC, but provided the following information from the bottle: PLD-H242C LB004314 Lot WJ00896 Expiration Feb2023. She then started getting hives on her neck. She was hot, flush, and dizzy. She felt like she was going to throw up. That passed. They then gave her Epi in the opposite arm, her right arm. She got the COVID vaccine in her left arm. Then, they got her ready to go to the hospital. The transfer was smooth. She was waiting for intake when she started to not be able to swallow. She complained quickly. The nurses ran to get Epi, but the paramedic grabbed the patient's Epi pen and injected it in her thigh. She was IVed up at the vaccine center before transfer. They gave her Benadryl, Pepcid, and methyl prednisone. The Epi pen they gave her was her own shot. They monitored her a few hours. Then sent her home with Pepcid, more Epi pens, and Prednisone for 4 days. She has had normal soreness in her arm at the injection site. It has been status quo, it feels like a tetanus shot. She still has swelling in tongue, but they told her that might take a day or two to go away. She is supposed to also take Benadryl for the next 2 days. She was given the vaccine at the (Place name). Events visit to Emergency Room. They did a CBC and she was in normal range for everything. Lab data included on 20Jan2021: CBC normal. Outcome of the event Swollen tongue was recovering. Outcome of the event Anaphylactic reaction/anaphylaxis was recovered. Outcome of the event injection site soreness was not recovered. Outcome of the events was unknown.
36 2021-02-05 lip swelling, lip pain, mouth tingling 24 hrs after 2nd dose, (approx. 2pm next day): body flushing and lip tingling noted. 40 hrs after (... Read more
24 hrs after 2nd dose, (approx. 2pm next day): body flushing and lip tingling noted. 40 hrs after (approx 6am 2 days after 2nd dose): moderate, painful upper lip swelling present for 10-12 hours. Body flushing, hot flashes noted on and off throughout day. Resolved without treatment.
36 2021-02-07 loss of taste Loss of taste; This is a spontaneous report from a non-contactable consumer reporting for herself. A... Read more
Loss of taste; This is a spontaneous report from a non-contactable consumer reporting for herself. A 36-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EL3247), via an unspecified route of administration in the right arm, on 21Jan2021 at 08:00, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced loss of taste on 21Jan2021 at 18:15 with outcome of recovered in Jan2021. No therapeutic measures were taken as a result of the event. Patient did not have COVID-19 prior to vaccination, and was not tested for COVID-19 after vaccination. No follow-up attempts are possible. No further information is expected.
36 2021-02-07 ear pain, pain in jaw PAIN ON INJECTION SITE,MUSCULAR PAIN,JOINT PAIN,PAIN ON EAR AND JAWS.
36 2021-02-07 mouth discomfort, ear discomfort States she feels burning in lips. Ears felt flushed @ 10AM. At 10:18AM States lips improved, no lo... Read more
States she feels burning in lips. Ears felt flushed @ 10AM. At 10:18AM States lips improved, no longer tingling only ears feeling hot. nurse supervisor spoke with Dr. who request to call PCP. Pt called PCP . 10:08AM BP 162/104, HR 84. 10:18AM BP 153/110, 10:36AM BP 158/100
36 2021-02-07 mouth tingling pt had itchy throat and tingly lips , pt offered Benadryl im and refused. symptom's did not worsen o... Read more
pt had itchy throat and tingly lips , pt offered Benadryl im and refused. symptom's did not worsen over 30 min observation and pt left clinic for home with no treatment.
36 2021-02-09 oropharyngeal discomfort 36 yo female received Pfizer Covid-19 vaccine #1 at Mass Vaccination Clinic , and shortly after in ... Read more
36 yo female received Pfizer Covid-19 vaccine #1 at Mass Vaccination Clinic , and shortly after in monitoring area, complained of wheezing (was diagnosed with bronchitis and wheezing the day before), itchiness of throat, subjective discomfort of throat (swelling) with swallowing within few minutes of vaccine. Exam: VS: HR 73, RR 20, BP 132/84, O2 sat 93%. BG 132 RUL wheezing, no lip/tongue/oropharyngeal swelling Albuterol MDI 2 puffs was taken. Benadryl 50mg po was given. Monitored for 50 minutes after vaccine. RUL wheezing improved, throat itching/discomfort resolved. Repeat VS: HR 70, RR 20, BP 116/72, O2 sat 93% (on RA). Pt discharged to home.
36 2021-02-09 oropharyngeal discomfort Pfizer-BioNTech COVID-19 Vaccine Anaphylaxis reaction Background -I have had one other anaphylaxi... Read more
Pfizer-BioNTech COVID-19 Vaccine Anaphylaxis reaction Background -I have had one other anaphylaxis event in my history in reaction to horse dander many years ago. As such per the guidance I remained in the waiting room for 30 minutes. After 30 minutes I had a light rash on both forearms and near the injection site on my left upper arm. I felt fine otherwise. I went up to the nurse in the monitoring room and showed her the rash. She asked if I was having trouble breathing. At the time I was not. She said I could take Benadryl for the rash as long as I had no allergy to Benadryl. I started driving home. During my drive my throat started to feel itchy and irritated. It proceeded to get worse and when I looked at my throat in the mirror it was very red and starting to be visibly swollen. I drove to the nearest hospital and checked myself in to the emergency room.
36 2021-02-09 feeling of choking, mouth tingling Patient stated that she felt hot and short of breath. Patient was offered an ice pack and a pulse o... Read more
Patient stated that she felt hot and short of breath. Patient was offered an ice pack and a pulse oximeter was placed on finger for obtaining O2 sat. Patient stated she felt flushed and that tongue and throat were tingling. EMS was called. Attempted to transfer patient to a wheelchair to relocated patient to clinic emergency area. Patient passed out and onsite MD consulted. Epi pen administered at 1021 via R arm and vitals monitored until EMS arrived. O2 sat 99%. BP 180/86 and HR 126. EMS arrived on site at 1040
36 2021-02-10 eye pain Extreme pain in eyes
36 2021-02-10 lip swelling 2/5/21- Received 2nd dose of COVID-19 vaccine 2/8/21- elbows and arms began to itch in the afternoon... Read more
2/5/21- Received 2nd dose of COVID-19 vaccine 2/8/21- elbows and arms began to itch in the afternoon. By the evening, legs and back were itchy too. 2/9/21- body from the neck down was itchy and covered in a red rash. Visited care clinic and received a prescription for Triamcinolone Acetonide Ointment 0.025% 2/10/21- woke up with swollen face and lips. swelling subsided within an hour of waking. Whole body still covered in rash and very itchy. was unable to complete a full day of work due to discomfort. 2/11/21- still covered in a full body rash and itchy with minor improvement.
36 2021-02-10 mouth tingling Tingling on upper lip
36 2021-02-10 taste disorder Mental foggyness/forgetful; Chills; Migraine; Dizziness; Fatigue; Loss of appetite; Food tasted salt... Read more
Mental foggyness/forgetful; Chills; Migraine; Dizziness; Fatigue; Loss of appetite; Food tasted salty/rotten; Diarrhea; Vomiting; intestinal discomfort; Cough with some shortness of breath (relieved with asthma inhaler); Cough with some shortness of breath (relieved with asthma inhaler); This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Solution for injection; lot number: EL3249, expiration date: unknown) via unspecified route of administration in the arm left on 22Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history included asthma, multifocal myoclonus, IBS/lynch syndrome, hypothyroidism, Allergy: Dairy (milk allergy), allergies, alcohol allergy, Allergy: beef (meat allergy), and allergy: adhesives (dermatitis contact). Patient was taking unspecified concomitant medications. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: urgent care center (also reported as Doctor's office). The patient experienced mental foggyness/forgetful, chills, migraine, dizziness, fatigue, loss of appetite, food tasted salty/rotten, diarrhea, vomiting, intestinal discomfort, and cough with some shortness of breath (relieved with asthma inhaler); all on 23Jan2021 at 06:00. The events resulted to: Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken in response to all events (unspecified). Patient also had teleconference with doctor. Outcome of all events was recovering.
36 2021-02-11 eye pain, ear pain Fever 102-103 (took fever reducers after 24 hrs) Chills Sweats Severe pain in left ear, throat, and ... Read more
Fever 102-103 (took fever reducers after 24 hrs) Chills Sweats Severe pain in left ear, throat, and down rib cage on left side Severe armpit pain (left) Severe headache Eye pain Overall discomfort
36 2021-02-11 eye pain Severe HSV2 outbreak 24-48 hours after injection. Gave acyclovir, calmed symptoms down. Stopped and ... Read more
Severe HSV2 outbreak 24-48 hours after injection. Gave acyclovir, calmed symptoms down. Stopped and 2 days later returned with rectal HSV, started 5 days acyclovir again, stopped and 2 days later had eye pain. Switched to valcyclovir for 30 days.
36 2021-02-12 mouth tingling, mouth itchiness Warm rush of heat overcame my body focused in my lower abdomen. I had an itchy, tingly feeling in m... Read more
Warm rush of heat overcame my body focused in my lower abdomen. I had an itchy, tingly feeling in my mouth-not throat. It was approximately 8 minutes after the vaccine. I was monitored. BP was fine, oxygen level was fine. My heart rate started out at 140 but quickly went down. No medicine was needed. Mouth feeling subsided in a minute or two. Warm sensation in abdomen intermittently returned for several hours post vaccine. I ultimately took Benadryl at home as a precaution. I did notice that sensation subsided then. I also had increased nasal discharge and slight cough the afternoon following the vaccination.
36 2021-02-12 swollen tongue, mouth swelling My face slowly started to swell and then on Tuesday afternoon it was extreme and very uncomfortable ... Read more
My face slowly started to swell and then on Tuesday afternoon it was extreme and very uncomfortable and scary because the sides of my face and Tongue was very swollen. Which made me panic and made it worse. I have the feeling in my cheeks like you were about to eat a lemon or lime were thinking about eating it the little tingling feeling but it was that times like 10. Went to the ER in And they gave me antibiotics and told me to eat a bunch of lemons or lemon drops and drink water. At first I didn?t even think it would be a reaction because it was three days later but the emergency doctor believes it was from the shot.
36 2021-02-13 thirst Severe, debilitating muscle pain over whole body beginning AM 2/11/21-AM 2/12/21. Moderate-severe mu... Read more
Severe, debilitating muscle pain over whole body beginning AM 2/11/21-AM 2/12/21. Moderate-severe muscle pain of back continued through 2/12 and became mild 2/13 AM until resolution felt 2/14. Fever ~101 F Afternoon 2/11-Early morning 2/12. Extreme thirst for only cold fluids afternoon 2/11-mid-morning 2/12. Severe fatigue 2/11 AM to 2/13 AM with dreams unable to awake from.
36 2021-02-14 mouth tingling, lip swelling Within minutes of taking the Pfizer vaccine I broke out in hives. My lips started tingling and slig... Read more
Within minutes of taking the Pfizer vaccine I broke out in hives. My lips started tingling and slightly swelling. I waited for 30 mins and EMT said it was safe for me to leave because it wasn't causing breathing issues. I took Benadryl when I got home and hives lasted 24 hours.
36 2021-02-15 lockjaw Moderate headache, chills, intense fatigue, feeling unwell/sick. All lasting from 2;00pm- present (... Read more
Moderate headache, chills, intense fatigue, feeling unwell/sick. All lasting from 2;00pm- present (11:50pm). My jaw was clenched. . I took Tylenol and an Ativan at 7:00 for my headache and jaw clenching but it did not seem to help. I put a heating pad on my neck and back of my head for the past two hours and this helped the pain.
36 2021-02-16 loss of smell, deafness became unresponsive after receiving her first dose of Pfizer Vaccine . Smelling salts were applied ... Read more
became unresponsive after receiving her first dose of Pfizer Vaccine . Smelling salts were applied and patient quickly became responsive. Patient was given 4 oz of apple juice which she tolerated well. Also complained of loss of hearing/smell and feeling flushed. Patient had no difficulty breathing and or rash. 911 was called and patient subsequently was sent to ER for further evaluation.
36 2021-02-17 vision blurred Fainting like episodes; Blurred vision; Severe vertigo; Chest pain; Fatigue; This is a spontaneous r... Read more
Fainting like episodes; Blurred vision; Severe vertigo; Chest pain; Fatigue; This is a spontaneous report from a contactable other health professional reported for herself. A 36-year-old female patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EL8982, via an unspecified route of administration in right arm on 15Jan2021 12:00 at single dose for covid-19 immunisation. There were no relevant medical history or concomitant medications. The patient was not pregnant at the time of vaccination.The patient had no allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.On 21Jan2021, exactly "4 1/2 days" after vaccine the patient experienced fainting like episodes, blurred vision, severe vertigo, chest pain, fatigue. The patient has been out of work since the 20th and she still had blurred vision. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received. The patient was not recovered from the events. She has been to the ER, cardiologist for an echography, ultrasonography of thyroids, Magnetic resonance imaging (MRI) of her head, went to ENT dr and neurologist in 2021. All blood work in 2021 came back normal as well. The reporter considered the event as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. She had negative Nasal Swab Covid test post vaccination on 22Jan2021.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of fainting like episodes cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-02-19 ringing in ears, blindness About 12 hours after receiving the shot, I woke up in the night feeling unusual. I went to the bathr... Read more
About 12 hours after receiving the shot, I woke up in the night feeling unusual. I went to the bathroom, where I felt pressure in my head, increased ringing in my ears, and increased loss of vision. A few moments later when I realized this was an emergency, I could no longer see or walk. I crawled blindly through the home feeling for the walls and familiar facets calling out for help. My family woke up and called emergency. By then, I was nearly gone/unconscious. I was laid down on cold tile until the paramedics arrived. Heart, blood sugar, and blood pressure were all tested. Considering I'm a completely healthy individual, they attributed it to the vaccine.
36 2021-02-20 lip swelling Rash began to appear on right cheekbone within 30 minutes of injection. Over the next 18 hours, ras... Read more
Rash began to appear on right cheekbone within 30 minutes of injection. Over the next 18 hours, rash spread to entire face. It is red and itchy, the skin is hot and tingly, and there is minor swelling. There is very minor lip swelling.
36 2021-02-23 tunnel vision Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as ... Read more
Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; I was nauseous and couldn't walk; I was nauseous and couldn't walk; Felt like immediate drop in blood pressure; This is a spontaneous report from a contactable consumer. A 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN5318, via an unspecified route of administration at left arm on 09Feb2021 10:00 at a single dose for COVID-19 immunisation. The patient had no medical history. The patient is not pregnant. There were no concomitant medications. On 09Feb2021, exactly two hours after injection, the patient felt lightheaded and dizzy while driving, then tunnel vision as if she was going to pass out. The had muscle weakness in my arms and legs. The patient managed to pull over safely. She was nauseous and couldn't walk. This lasted about 15 minutes and then she was better. The patient felt like immediate drop in blood pressure. No treatment was received. The outcome of the events was recovered on an unspecified date.
36 2021-02-24 deafness Felt lightheaded, tingling. Described feeling as if her ears were going to cave in and had "hearing ... Read more
Felt lightheaded, tingling. Described feeling as if her ears were going to cave in and had "hearing change". BP 70/90. HR 60. Medics on site. Evaluated. Once feeling better able to leave clinic on her own.
36 2021-02-25 taste impairment 12w 1d pregnant, The first day I had nausea, fatigue, injection site discomfort, metallic taste in m... Read more
12w 1d pregnant, The first day I had nausea, fatigue, injection site discomfort, metallic taste in my mouth. The second day (today), I had nausea, fatigue and diarrhea.
36 2021-02-25 eye discomfort 1st dose: 24 hrs after administration, I developed a searing migraine that lasted for approx 15 hour... Read more
1st dose: 24 hrs after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explore; 1st dose: 24 hours after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explor; 1st dose: 24 hours after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explor; This is a spontaneous report from a contactable self-reporting other health professional. A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686), intramuscularly on an unspecified date in Jan2021 at 13:00 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included anaphylactic reactions to penicillin and pistachios. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered to the patient in a hospital. The patient reported that twenty-four hours after administration she developed a searing migraine that lasted for approximately fifteen hours. She stated that "no medications could touch the pain" and it felt like her brain and eyeballs were going to explode. The patient specified that she did not receive any treatment for the events. The clinical outcomes of migraine, sensation of pressure and eye discomfort were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
36 2021-02-28 double vision, vision blurred Headache , Dizziness, unsteadiness, diploplia, blurry vision started 1 week after second dose
36 2021-03-01 tongue disorder Patient describes "ridges" on tongue and Hives to chest
36 2021-03-02 mouth numbness, taste impairment Lost feeling in face, tongue, mouth. Numbness in cheeks - 2 hours after vaccine Metallic taste immed... Read more
Lost feeling in face, tongue, mouth. Numbness in cheeks - 2 hours after vaccine Metallic taste immediate after vaccine. Treated with Benadryl. 27 weeks pregnant - Due May 31, 2021.
36 2021-03-03 lip swelling, mouth tingling My symptom began with an itchy spot on my left forearm advancing to the back of my neck and head fol... Read more
My symptom began with an itchy spot on my left forearm advancing to the back of my neck and head followed by a rash. The rash extended over my neck, chest, face, spreading to entire body. The left side of my lip also had swollen and became tingly. All symptoms started roughly at 3am on 3/4/21. I took ibuprofen 800mg along with Benadryl 25mg. At 0730am rash had dissipated some and most of the itching subsided, another Benadryl 25mg tablet was taken. At 1030am, rash had dissipated except still remaining on both elbow areas, non itching at this point. At 1230, another Benadryl was taken.
36 2021-03-03 swollen tongue I initially had itchiness at injection site, then more of my arm. At 15 minutes I talked with the nu... Read more
I initially had itchiness at injection site, then more of my arm. At 15 minutes I talked with the nurse, she looked at and we talked for quite a bit what I should do but I was feeling just fine and left to go home and take benedryl. I had just left the hospital (25 mins post shot) and my throat and tongue started swell rapidly. I called 911 and the county rescue responded. My breathing was normal by then. My body has been itchy all over since then and my throat remains minor swollen. I did not get an epi shot since I was mostly okay and the EMTs were convinced I had a panic attack so I just went home.
36 2021-03-03 swollen tongue Was released from the testing site 5-10 minutes after second dose was administered. Approximately 15... Read more
Was released from the testing site 5-10 minutes after second dose was administered. Approximately 15-20 minutes after dose was administered I began feeling a reaction. The skin on my face, neck, and chest became red, flushed, warm, splotchy, and itchy. My tongue and throat began to feel swollen/tight. I was also lightheaded and dizzy. My husband was driving the car and we almost returned to the vaccination site, but after approximately 5 more minutes, the tightness in my throat subsided, so we continued to go home. The flushing and lightheaded-ness went away after approximately 20 minutes. This is similar to the reactions I had just before I discontinued taking copaxone (approx. 2 years ago). I did not feel this way after dose one of the Pfizer COVID vaccine.
36 2021-03-04 lip swelling, lip itchiness Upper lip itched and was slightly puffy. Next day it returned to normal but bottom lip became itchy ... Read more
Upper lip itched and was slightly puffy. Next day it returned to normal but bottom lip became itchy and felt 2 little bumps underneath. I assume it was hives.
36 2021-03-04 feeling of choking Slight tickling in the back of throat, clearing throat and small hive on left forearm, redness of sk... Read more
Slight tickling in the back of throat, clearing throat and small hive on left forearm, redness of skin. Administered Zyrtec and resolved within 20 minutes.
36 2021-03-06 lip swelling hives/rash across various body parts, including behind the knees/elbows, on the neck/arms/thigh/butt... Read more
hives/rash across various body parts, including behind the knees/elbows, on the neck/arms/thigh/buttock (since 2/12/2021, ongoing); swollen lips, tingling lower jaw (since 2/12/2021, for 2 weeks); body ache (since 1/27/2021 for one week); chills and headache (since 2/17/2021, ongoing).
36 2021-03-07 taste impairment, smell distorsion Progress Notes (Physician Assistant) ? ? Family Medicine Cosigned by: MD at 3/8/2021 10:37 AM Expand... Read more
Progress Notes (Physician Assistant) ? ? Family Medicine Cosigned by: MD at 3/8/2021 10:37 AM Expand AllCollapse All 3/5/2021 Subjective Patient is a 36 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience chills and a "nasty taste" in her mouth. She described this to be a metallic taste later on and stated she could smell it as well which was making her nauseous. She also mentioned belching started after her vaccine. She denied difficulty breathing, difficulty swallowing, throat tightness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, skin changes, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills Patient denies fever, facial swelling, chest tightness, shortness of breath, wheezing, dizziness and headaches "Nasty" taste and smell. : Previous Reactions: Denies Objective Vitals Vitals: 03/05/21 1124 03/05/21 1144 BP: (!) 145/61 126/55 Pulse: 93 SpO2: 100% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: water and Pepcid. Gave two lozenges to help with bad taste. Follow up response to treatment: good. She had complete resolution of symptoms within a few minutes of taking the Pepcid 20mg solution. I continued to observe her for another 10 minutes and the taste did not return. Patient discharge: Stable to go home and follow up with PCP.
36 2021-03-07 eye swelling, vision blurred, mouth numbness patient received vaccination around noon and approximately 8-10 hours later developed swollen eyes, ... Read more
patient received vaccination around noon and approximately 8-10 hours later developed swollen eyes, lip and tongue numbness, intermittent blurry eyes, nausea. She has taken Benadryl, Singulair, Zyrtec without relief of symptoms. No difficulty breathing.
36 2021-03-07 mouth tingling, mouth numbness Mouth and tongue tingle tongue numb rash on face.
36 2021-03-07 visual impairment On 2/28/20 I woke up with balance problems made worse with eyes closed or when moving my head. These... Read more
On 2/28/20 I woke up with balance problems made worse with eyes closed or when moving my head. These balance issues are slowly improving but remain ever present. I am also experiencing some cognitive issues including word finding problems, difficulty processing verbal information, and general brain fog. I?ve had an increase in fatigue as well. The same weekend the balance issues began I had some visual disturbances as well.
36 2021-03-08 eye itchiness, eye swelling A few hours after receiving the vaccine I started to feel fatigue and started getting shooting pains... Read more
A few hours after receiving the vaccine I started to feel fatigue and started getting shooting pains through my back, injection site was slightly sore. Second day my whole body felt stiff. Third day I started getting shortness of breath. Fourth day I woke up with swollen itchy eyes and ears as well as a sore throat. It started to become even harder to breath. I took allergy medicine, Allegra and zertex and felt some immediate relief.
36 2021-03-08 mouth numbness Face got very hot, then mild numbness throughout cheeks, in eyes, tongue, and throat.
36 2021-03-09 swelling around the eyes This morning I woke up swollen under my eyes right where I had filler done; The swelling and tendern... Read more
This morning I woke up swollen under my eyes right where I had filler done; The swelling and tenderness is the exact same swelling and tenderness experienced right after the filler was done; achy and tired; achy and tired; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration in the left arm on 05Feb2021 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history included Celiac disease, allergy to gluten, filler under eyes in Jul2020, and the patient is prone to inflammation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included GUARANA [PAULLINIA CUPANA] and a multivitamin, both from an unknown date for an unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unknown date for COVID-19 immunization and experienced fatigue and feeling achy. The patient stated she did not have any kind of reaction to her first dose other than fatigue and feeling achy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021 the patient experienced feeling achy and tired, the patient had no other initial reactions after the injection. On 07Feb2021 at 06:30, the second day after the second immunization, the patient woke up swollen under her eyes right where she previously had filler done (last Jul2020, so per the patient, it wasn't recent). The patient stated the swelling and tenderness was the exact same swelling and tenderness that the patient experienced right after she had the filler done. The patient stated she should also note that she does have Celiac disease, which is an autoimmune disease and she is prone to inflammation, however the patient was not on immunosuppressant drugs and was otherwise very healthy. The patient did not receive any treatment for the events feeling achy and tired, swelling and tenderness under her eyes. The clinical outcome of the feeling achy and tired, swelling and tenderness was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
36 2021-03-10 sensitivity to light Bad sensitivity to light. Had to wear sunglasses indoors. Migraine headache for 7 straight days. Hea... Read more
Bad sensitivity to light. Had to wear sunglasses indoors. Migraine headache for 7 straight days. Head felt like it was in fishbowl, sounds muffled, hard to concentrate, or give answers, brain felt disconnected. Felt cold a lot but did not have fever, generally weak and tired. I?m starting to feel better but still have a couple times a day that this happens.
36 2021-03-11 lip swelling, swollen tongue, mouth tingling, dry throat About 15 minutes after the dose of Pfizer started to feel tingling and swelling of her lips. Stated ... Read more
About 15 minutes after the dose of Pfizer started to feel tingling and swelling of her lips. Stated it came and went but after another 10 minutes stated she thought her tongue was starting to swell in the front and then moved to the back....also, stated it came and went. Has had fillers in her lips so difficult to assess their size. No SOB, sweating, hives, itching, Dryness of throat improved with water. Evaluated by crisis nurse but Eppy never given Monitored for 1 hour with resolution of problems. BP 108/72 with pulse oxy of 97. Left clinic area accompanied by her physician husband and will call her allergist about further directives and whether or not she should get a second vaccine. Refused to be monitored in ED or go there for more evaluation.
36 2021-03-11 visual impairment I was fine for a few days. On day 3, I started to get bad headaches. By the weekend I was vomiting, ... Read more
I was fine for a few days. On day 3, I started to get bad headaches. By the weekend I was vomiting, couldn't see, and had the aura. I messaged by neurologist and she gave me a steroid pack, which resolved the issue in about 2 days.
36 2021-03-14 bleeding gums, painful gums Gums hurting and randomly starting bleeding without being touched. Gums very sensitive. I also fee... Read more
Gums hurting and randomly starting bleeding without being touched. Gums very sensitive. I also feel extremely tired since day of Injection. It is now two days later. My mouth feels strange like I?m clenching my jaw. Perhaps feeling more sensitive to the physical effects of caffeine after only 1 small cup of coffee.
36 2021-03-15 dry eye, eye irritation, eye swelling Few hives (both eyes) starting at 7PM on 3/15/21. Took benadryl right away. Swollen and dry eyes (bo... Read more
Few hives (both eyes) starting at 7PM on 3/15/21. Took benadryl right away. Swollen and dry eyes (both eyes), also felt burning, when woke up at 8AM on 3/16/21.
36 2021-03-16 ringing in ears Tinnitus
36 2021-03-18 eye itchiness, lacrimation increased, bloodshot eyes Pfizer-BioNTech COVID-19 Vaccine EUA Red, itchy, watery eyes. It started when I woke up the next mor... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Red, itchy, watery eyes. It started when I woke up the next morning. It has gotten worse over the next few days. No other symptoms. Dr. prescribed prednisone, Benadryl, Claritin, eye drops.
36 2021-03-18 swelling of eyelid, eye itchiness 27 hours after vaccine, my left eye started to itch and felt dry. Overnight it began to swell to the... Read more
27 hours after vaccine, my left eye started to itch and felt dry. Overnight it began to swell to the point of being closed shut by 4:00am on 3/19. It was also warm and throbbed slightly. I took a Benadryl by 4:30am. Swelling reduced slightly. I took a 2nd Benadryl by 11am swelling reduced slightly. It is 316pm and eye is still swollen and warm to touch. Not swollen shut though. Swelling is all along eyelids, under and above eye and inner corner of eye.
36 2021-03-21 ear swelling, ear pain Earache, swollen ear, tenderness, Spot bleeding Took tylenol, diphenhydramine
36 2021-03-22 mouth tingling Systemic: Tingling around gums-Mild, Additional Details: Pt hx: Contrast allergy 15 years ago. No an... Read more
Systemic: Tingling around gums-Mild, Additional Details: Pt hx: Contrast allergy 15 years ago. No anaphylactic shock. Symptoms remembered: Heart palpitations\r\nPt symptoms: tingling around gums, no swelling, no rash\r\n1830 Vitals; 158/102, HR 101, O2 Sta 99%, Temp 98.1\r\n1855 Vitals; 130/90, HR 88, RR 16, 98% O2 Sat.\r\recommended repeat Benadryl dose of 25 mg and contact/ work up with PCP.
36 2021-03-24 mouth numbness tingling/numbness in left hand, traveled up the arm; Tingling/numbness in left hand, traveled up the... Read more
tingling/numbness in left hand, traveled up the arm; Tingling/numbness in left hand, traveled up the arm/ Skin on jaw went numb for an hour/ recurring along with all over the body; lips began to go numb; left wrist felt as if it was filled with fluid with no visible swelling; Pain on the back of the left hand is intense and unrelenting.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) via an unspecified route of administration, on 17Mar2021 at 3:00 PM (at the age of 36-years-old, not pregnant) as a single dose in the left arm for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. No known allergies. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks administered. On 18Mar2021 at 3:45 PM, the patient experienced tingling/numbness in left hand, traveled up the arm, lips began to go numb. The left wrist felt as if it was filled with fluid with no visible swelling. This has traveled all over various parts of the body. Skin on jaw went numb for an hour. Hand numbness was recurring along with all over the body at differing times. Pain on the back of the left hand is intense and unrelenting. The adverse events reported resulted in emergency room/department or urgent care, hospitalization. The patient was hospitalized for one day on an unspecified date in 2021. The treatment administered for the reported events were Benadryl and Pepcid via intravenous (IV) route. The outcome of the events was not recovered.
36 2021-03-24 thirst Rash all over my body, itchy, within 1.5 hours of receiving shot. Took Benedryl. Went away. When Ben... Read more
Rash all over my body, itchy, within 1.5 hours of receiving shot. Took Benedryl. Went away. When Benedryl wears off, rash comes back. Low grade fever developed 7 Pm first night and has been going away and coming back for two days along with chills. Extremely thirsty. Soreness of arm where injection was done. Redness. Occurred next day. Been using ice packs on arm and face. Face has bad rashes. Muscle and joint pains for the last day and a half.
36 2021-03-25 oropharyngeal discomfort A few hours after vaccine began getting itchy all over and slight numbness on left side. Went to ER ... Read more
A few hours after vaccine began getting itchy all over and slight numbness on left side. Went to ER and was given benadryl. The next morning 3/22 I woke up with hair feeling in my throat and heart palpitations. Went back er BP and treated with hydrolyzed hcl, Famotadine, lorazepam and Prednisone. By the evening 911 was called and I was taken back to er BP for heart rate of 150 +, light headed and nausea. I was treated with clonazepam and discharged that night. On today 3/26 I am still experiencing fast heart rate and taking atarax as needed.
36 2021-03-25 swollen tongue, feeling of choking Received the vaccine at 10:40am on 3/24/2021 and felt normal. At 1:20pm anaphylaxis set in - experie... Read more
Received the vaccine at 10:40am on 3/24/2021 and felt normal. At 1:20pm anaphylaxis set in - experienced tingling then tightness in throat, tongue swelled, swallowing would cause me to choke and tongue would get stuck blocking air passage. Hyperventilating began as I could not get enough air into my lungs. For 15 minutes tried drinking water and laying down to help open airways. Breathing slightly eased for 2-4 minutes and then the anaphylaxis would spike again. This happened 3x getting worse, I called my Primary Care Physician's office and was advised to go to the ER immediately. At 2:15pm I arrived at the ER and at 2:30pm I was given a 1mg shot of EPINEPHrine, and intravenous shots of diphenhydrAMINE, methylPREDNISolone, and famotidine along with oxygen. Anaphylaxis finally dissipated around 3:30pm and by 5pm I was breathing more normally. I was discharged at 7:00pm, and was feeling very energized. I was also given a prescription for an epipen incase I should have any further issues. The next morning, 3/25/2021 I woke up after 5 hours of sleep feeling extremely energized. I had a virtual doctor's appointment with my allergist, Dr. at 12:00pm. My doctor was surprised at how well I seemed to be doing and we made arrangements to do further allergy tests in 2 weeks. We came to the conclusion that I am most likely allergic to POLYETHYLENE GLYCOL. This ingredient is also in a cold medicine that I was taking in January and I was experiencing minor anaphylaxis (which I thought was due to the extreme congestion I was experiencing with the cold). It is also an ingredient (aka PEG) in an eye cream that caused a severe eczema patch under my eye in January. After my appt, at 1:30pm I went into anaphylaxis again. My throat got tingley and began to close, my tongue swelled and again was getting stuck in my throat when I attempted to swallow. I laid down and tried to get in deep breaths. My husband bought children's BENADRYL, which does not have polyethylene glycol in it, and gave me 15ml at 2:15pm. I reached out to my allergist, Dr. and updated him. He advised that I immediately take an additional 5ml of the BENADRYL. Dr. prescribed me 60mg/day Prednisone for 2 days followed by 40mg/day of Prednisone for 4 days, 40mg/day Famotidine for 2 weeks, 10mg/day antihistamine (I chose loratadine) for 2 weeks. Dr. also shared that I should have been prescribed steroids when I was discharged from the hospital, but my energetic state gave the impression I was OK. My manic energy was a result of the epinephrine, which had finally worn off 23 hours later, causing my body to begin the allergic reaction all over again. The evening of 3/25/2021 (after the first dose of 60mg prednisone, 40mg famotidine, and 10mg loratadine) and all three meals on 3/26/2021 I experienced minor anaphylaxis when I began to eat. Tightness in throat throughout the meal and lasting an additional 20 minutes following the meal. My throat has reopened after each incident on 3/26/2021 and I was able to breathe normally again.
36 2021-03-26 vision blurred Warm sensation all over body, blurred vision in right eye, flushing, hives over chest, neck, and arm... Read more
Warm sensation all over body, blurred vision in right eye, flushing, hives over chest, neck, and arms, high heart rate and high blood pressure. Happened just minutes after injection. Given 50mg Benadryl and observed by Medics for an hour.
36 2021-03-26 visual impairment Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-M... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild
36 2021-03-27 taste impairment Felt a metallic taste in my mouth within a few minutes after receiving 1st dose of Pfzier Covid-19 V... Read more
Felt a metallic taste in my mouth within a few minutes after receiving 1st dose of Pfzier Covid-19 Vaccine. Only lasted for a few seconds and then taste was normal again.
36 2021-03-27 swelling of eyelid Puffed/swollen and itchy left eyelid at 11:06pm and swelling of the throat. Symptoms did not get sig... Read more
Puffed/swollen and itchy left eyelid at 11:06pm and swelling of the throat. Symptoms did not get significantly worse by 2am so I went to sleep and did not seek medical attention. Did not take any medication as didn?t have any Benadryl or anything available
36 2021-03-28 ear pain Sharp and burning pain in left hip, buttock, and thigh followed by similar pain in left arm. Experie... Read more
Sharp and burning pain in left hip, buttock, and thigh followed by similar pain in left arm. Experiencing radiating pain, pins and needles, and muscle weakness in both left leg and left arm which are simultaneous. I also have mild pain in left ear. I took Ibuprofen for about a week but had to finally go to Urgent Care. After blood test and X-ray results came back normal, I was prescribed Gabapentin and was referred to a neurologist. I had an MRI on 03/25/2021 and waiting for the results.
36 2021-03-28 mouth numbness, mouth tingling numbness and tingling that started in mouth and tongue and spread to extremities. lasted for 4 days.... Read more
numbness and tingling that started in mouth and tongue and spread to extremities. lasted for 4 days. went to ER for evaluation
36 2021-03-29 mouth tingling, feeling of choking About 30 minutes after the shot, i began to have an allergic reaction to the shot. Scratchy throat, ... Read more
About 30 minutes after the shot, i began to have an allergic reaction to the shot. Scratchy throat, minor breathing issue (like couldn't take a deep breath), itchy palms, head and feet. Off fire/tingle sensation in back of throat and tongue. I waited about an hour and a half and it was not getting better so I took one Benedryl pill and it resolved all issues.
36 2021-03-29 feeling of choking Felt itchiness and tingling in throat. BP 103/68 (pulse 60), O2 sat 100%. Given Benadryl 50 mg PO.
36 2021-03-29 ringing in ears Ringing in ears
36 2021-03-30 vision blurred 1:50 waiting in observation area, became dizzy and lightheaded. Shaking, states very cold. Extremit... Read more
1:50 waiting in observation area, became dizzy and lightheaded. Shaking, states very cold. Extremities cold. Color pale, nail beds cyanotic. Lips gray. Patient crying. States she experienced a pain in her right arm down the arm after the injection. BP 110/84 HR 63. O2 sat 100% on room air . Hasn't eaten, had a protein drink for breakfast. States she had to stop taking the phentermine suddenly due to supply issue at pharmacy. Has been taking it for weight loss for over a year. States having blurred vision. EMT present. 2:00 Glucose 56 gave patient juice and teddy grahams. Patient drank juice, nibbled on crackers. 2:10 - Glucose recheck 62. Ate two teddy graham crackers. Encouraged to eat more and drink water, declined. Color remains pale, nailbeds still blueish. HR 60 slow and regular per auscultation. Patient still cold and shaking, has sweater on. Still having blurred vision. States she can't think clearly. Patient drove self. Instructed that she shouldn't drive home and recommended transport to hospital. 2:12 EMS activated 2:34 EMS arrived. EKG done. 2:37 BP 104/67 HR 59 2:47 BP manual per EMT was 110/70 2:50 Glucose 110 recheck per EMT 3:00 EMT states that they completed orthostatic BP checks and her BP remained stable. Patient's color improving. Patient declined transport per EMS. States that she will contact her co-worker to come pick her up at vaccine site. 3:10 patient ambulated (accompanied by nurse to door ) to her own car, states she will wait inside for friend and not drive herself. Signed refusal for transport.
36 2021-03-31 loss of smell completed because of being Tested positive for COVID-19 infection 14 or more days after being fully ... Read more
completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:1/27/2021.pfizer Lot#EL9262 2nd dose:01/06/21.pfizerLot#EL9262 Diagnosed covid positive: 03/24/21 Exposure:Unknown Symptoms:Headache, rhinorrhea, Insomnia, loss of smell, congestion
36 2021-03-31 sensitivity to light Vaccine on 3/28. 45 min after vaccine felt cold sweats, nausea. 3/29 ongoing cold sweats, nausea, fa... Read more
Vaccine on 3/28. 45 min after vaccine felt cold sweats, nausea. 3/29 ongoing cold sweats, nausea, fatigue, mild body aches. Went to work, symptoms worsened and developed severe body aches, headache, photophobia, gasping for air (but could breathe ok). Got up from a chair and syncopized, unknown amount of time unconscious. Taken to ED, normal exam, diagnosed with vasovagal syncope, went home to rest remainder of day. 3/30 still fatigued, tried drinking coffee and it spilled out right side of mouth. Looked in mirror and thought right eye and lip were drooping. Touched face and could not feel anything on right side. Also noticed splotchy red rash bilateral cheeks and left arm (same as injection) that was itchy. Saw PCP (via tele) who documented decreased right smile, forehead elevation, cheek puff and decreased sensation on face. Prescribed 7 day course of Valtrex TID and Prednisone 60mg daily which she began on 3/31. Seen by neurology (via tele) 4/1, patient indicating 50% improvement in symptoms but states she cannot feel entire right side of face or ear. When talking appears to only be talking out of left side of mouth but no flattening of right nasolabial fold, normal smile, cheek puff, questionable asymmetry of right forehead elevation but symmetric eyebrow furrow. Unable to assess forced eye closure. States she cannot feel pinch or nail on right side of face.
36 2021-03-31 swollen tongue Severe anaphylactic. Tongue swollen throat swollen. Facial swelling throat swelling. First occurr... Read more
Severe anaphylactic. Tongue swollen throat swollen. Facial swelling throat swelling. First occurred at 10:50. Epi pen given. Second wave of symptoms at 1. 2nd dose epi given to leg and went to emergency room
36 2021-03-31 taste disorder Immunization 3/26/2021 COVID Vaccine Clinic Need for vaccination +1 more Pt. who was seen at COVID... Read more
Immunization 3/26/2021 COVID Vaccine Clinic Need for vaccination +1 more Pt. who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 originally but ended up for 30 due to how she was feeling waiting period after the injection, the patient began to experience lightheadedness and nausea with brief "funny taste in mouth". She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches + nausea: + lightheaded: Previous Reactions: none Objective Vitals Vitals: 03/26/21 1230 03/26/21 1330 BP: (!) 138/92 108/68 Pulse: 92 SpO2: 98% Physical Exam Constitutional: Appearance: She is not diaphoretic. Comments: Flushed. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Regular rhythm. Tachycardia present. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Pt with int waves of nausea. Treated with pepcid and zofran x 1 with temporary relief. 1250 pt with emesis in bay, good amount 1252: pt given zofran and more ice packs. 1300: pepcid given again 1310: pt with emesis again. Assessment/Plan Treatment included: water and pepcid, zofran Follow up response to treatment Patient discharge: Transported to ED by ambulance. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Pt unable to tolerate po fluids. Emesis frequency not changed. Discussed with patient about options, she wishes to be taken to ED via EMS Husband and daughter will meet her there. ED manager updated.
36 2021-03-31 tunnel vision C/o of dizziness and tunnel vision right after receiving vaccine. Able to move to the bed on own. In... Read more
C/o of dizziness and tunnel vision right after receiving vaccine. Able to move to the bed on own. Initial BP 116/70, HR 66, O2 sat 99%. Does have history of HIV infection for which she take PO meds "for a long time". Vital signs remained stable throughout her stay. Able to dangle and ambulate without dizziness. Drinking water. Symptoms resolved on their own. Discharged feeling much improved.
36 2021-04-01 mouth tingling Day 0 day of vaccine tingling hand post injection Day 1 sore arm 24 hrs Day 2 nothing Day 3 tingli... Read more
Day 0 day of vaccine tingling hand post injection Day 1 sore arm 24 hrs Day 2 nothing Day 3 tingling lips, hand, middle finger pain Day 4 middle finger pain, tingling/burning spot on leg Day 5 nothing Day 6 leg pain, numb, tingly, burning sensation Day 7-8 finger pain, decreased sensation to left side Day 9-10 finger pain, chest pain Day 11 tingling left shoulder Day 12 decreased sensation left side Day 13 weakness with left side and grip strength Day 14 sharp shooting pain left back
36 2021-04-01 swollen tongue EE states jaw tightness, tongue swelling, horse voice, had to keep clearing throat, tachycardia- emp... Read more
EE states jaw tightness, tongue swelling, horse voice, had to keep clearing throat, tachycardia- employee was advised ER visit is necessary for this. Employee seen at local ER treated with Benadryl and Oral steroids, released to home. Diagnosed with angioedema.
36 2021-04-02 ear pain, ear infection, deafness, pain in jaw, ear swelling The first day about 10 minutes after I got the shot I had hives on both arms and an instant migraine... Read more
The first day about 10 minutes after I got the shot I had hives on both arms and an instant migraine. The hives went away after an hour or two but the migraine was present for 3 days. On March 31st I started having jaw and ear pain and April 1st hearing loss. On April 3rd, I went to the ER due to my ear canal closing completely, swelling and lots of pain. I was put on amoxiccilan and ear drops to treat outer ear infection. I still cannot hear.
36 2021-04-04 lacrimation increased Cough, Congestion, Achy, Tired, watery eyes
36 2021-04-04 tunnel vision A few minutes after vaccination the pt had what appeared to be a seizure with momentary loss of cons... Read more
A few minutes after vaccination the pt had what appeared to be a seizure with momentary loss of consciousness. Profuse sweating, tunnel vision and syncope also present. EMS was called and patient was transported to hospital directly from the pharmacy.
36 2021-04-05 lip swelling Got fever on the following day 4 am. Body ache sore, fever temperature 99.7F. Took 400mg of ibuprofe... Read more
Got fever on the following day 4 am. Body ache sore, fever temperature 99.7F. Took 400mg of ibuprofen and went back to sleep. Fever diminished in the morning. In the early afternoon on the same day. Right top Lips got very swollen, seems like a delay allergic reaction. Didn?t intake anything unusual. Took one Claritin. Symptom persist. 9pm, lips swollen Is lessen but still persist.
36 2021-04-06 swollen tongue, pain in jaw In observation area, my tongue swelled up - nurse held be back for a bit to observe and gave me bott... Read more
In observation area, my tongue swelled up - nurse held be back for a bit to observe and gave me bottled water. The injection site arm went dead and unable to move (left arm stated on my vaccination card but it was the RIGHT arm that was jabbed. Another inconsistency of this whole process). I had weird tingliness shooting up to my neck/back of neck. After finally being released from the observation area when the tongue swelling went down, I was tired walking to my car. That night I was exhausted and couldn't get off the couch and nauseated. The nausea and fatigue hit in waves over the next day. On Monday (second morning after the shot), I could not get out of bed. After finally getting up, I went to work. At work I was still dealing with fatigued, shortness of breath, my head was dizzy and light, then mid-morning I had sharp stabbing chest pains under my left breast, the pain shot up to my left neck and jaw. I could not breathe. The more I tried to breathe, the sharper my chest pains became. I had emailed my primary care doctor twice that morning because of symptoms and never heard back so when the chest pains hit, I went to the ER. At the ER they ran EKG, blood work, XRays. Kept me all day. At the end, they told me I was healthy and let me go. The doctor had ZERO regard or interest in the fact that all of this started after the vaccine. No where in my notes was it noted that I had the vaccine. The nurses told me this was a trend with the patients coming into ER complaining of post-vaccine symptoms and not having them documented. I had breathing issues for almost two weeks after the vaccine where I would be short of breath and winded, not able to complete sentences without stopping for air. I still have awkward breathing moments. I called healthcare facility nightly to report this and again was told to just monitor my symptoms. I feel like this whole process has been an isolating, careless time where my vaccine side effects have NOT been taken seriously.
36 2021-04-06 ringing in ears Developed tinnitus in left ear.
36 2021-04-07 loss of smell, loss of taste, taste impairment, smell distorsion Since being vaccinated I have not felt well at all. Low grade fever on and off since 3/23, chest con... Read more
Since being vaccinated I have not felt well at all. Low grade fever on and off since 3/23, chest congestion, painful phlegmy cough, loss of taste and smell with the exception of metallic taste/smell, fatigue, low energy. Not feeling like myself at all. I am worried.
36 2021-04-07 canker sore, mouth pain 1. Chest Pressure and fast heart beat; the chest pressure started 2 minutes after the vaccine and l... Read more
1. Chest Pressure and fast heart beat; the chest pressure started 2 minutes after the vaccine and lasted non stop for 14 days. The fast heart beats have been happening also 2 minutes after the vaccine but they have been inconsistent and also lasted for 14 days. As of now I feel fine but I'm unsure if the reaction is fully gone. 2. Canker Sores in the roof of my mouth, this started 1 day after the shot, it felt like I had knifes cutting the roof of my mouth, I still have them but they are going away. The intense pain lasted for 2 days then after that it started getting better but I was having difficulty eating for 5 days. 3. I have been having brain fogs after the vaccine, I'm finally starting to feel myself today.
36 2021-04-07 dry mouth Dry mouth/tongue. Attempted to drink extra water, it didn't help. My mouth was quite dry. It was mil... Read more
Dry mouth/tongue. Attempted to drink extra water, it didn't help. My mouth was quite dry. It was mildly uncomfortable. It continued after eating. I went to sleep around 1:30 AM, it was gone when I woke up this morning, April 8 2021 (around 10am)
36 2021-04-07 oropharyngeal discomfort Patient felt itchiness and throat discomfort. No respiratory distress. Patient stated it felt like ... Read more
Patient felt itchiness and throat discomfort. No respiratory distress. Patient stated it felt like throat was tightening. She brought her own Epi Pen (Seafood anaphylaxis) and was instructed to self administer. 911 / EMS took her to nearest hospital
36 2021-04-07 mouth tingling c/o tingling to her tongue and itching to left side of face approx. 30 minutes after vaccination. No... Read more
c/o tingling to her tongue and itching to left side of face approx. 30 minutes after vaccination. No SOB, dizziness, CP. Given PO Benadryl 50mg. Declined transport to ER.
36 2021-04-07 vision blurred Patient developed blurred vision in the right eye shortly after receiving vaccination. Patient was e... Read more
Patient developed blurred vision in the right eye shortly after receiving vaccination. Patient was evaluated by medic and a health care provider. Symptoms resolved spontaneously without treatment.
36 2021-04-08 ear pain, visual impairment After about 5 hours of injection, started feeling like in a different world and developed a severe h... Read more
After about 5 hours of injection, started feeling like in a different world and developed a severe headache, later a slight fever and muscle pain. Took tylenol every 6-12 hours for two days. After about 30 hours symptoms went away but had a headache frequently. Last night I got a poor eye sight and my right arm was numb and had a pain on left side of head including ear. I went to the emergency room. Some of tests were done and they came up normal. I was prescribed butalbital-acetaminophen-caff for migraine. I am not sure whether this is related or not. But, I have my second dose scheduled to 22 nd of April and I am concerned about the side effeccts.
36 2021-04-09 extreme sound sensitivity, sensitivity to light Sunday night had flu-like symptoms, skin and tongue felt funny. Extreme light and sound sensitivity ... Read more
Sunday night had flu-like symptoms, skin and tongue felt funny. Extreme light and sound sensitivity but no migraine pain, just discomfort. Monday-Tuesday felt extremely lethargic, slept most of the days. Wednesday my brain felt more alert but my body still felt funny, and the sound sensitivity was gone but the light sensitivity was still there. Was able to do some exercise. Each day has improved but now it?s Friday night and I continue to feel skin and light sensitivities.
36 2021-04-10 dry mouth Pt reported she was feeling nauseous,hot and a dry mouth. Nausea proceeded to dry heaves w/o vomitin... Read more
Pt reported she was feeling nauseous,hot and a dry mouth. Nausea proceeded to dry heaves w/o vomiting. Vitals remained stable,airway was not compromised. S/S lasted 45 min, with hydration pt returned to baseline. Evaluated by PA in house.
36 2021-04-10 visual impairment Mild allergic reaction-patient felt like throat was tightening /burning, seeing spots, dizziness
36 2021-04-11 eye twitching Day 2-3 (Friday - Saturday) - [ ] Random twitching throughout body in muscles? (arm, legs, head once... Read more
Day 2-3 (Friday - Saturday) - [ ] Random twitching throughout body in muscles? (arm, legs, head once) (feels like something is crawling under my skin) - [ ] Fatigue - [ ] Tight muscles Day 4 (scary night time episode) - [ ] Moderate to severe Muscle spasm with no pain in legs worse in left leg - [ ] Sweating - [ ] Heart fluttering - [ ] Chills with moderate shaking - [ ] High pulse - [ ] Tight muscles - [ ] Continuous twitching through body in muscles? (arm, legs, back, chest, butt, chest) Day 5 (Monday) visited Urgent Care - [ ] Moderate Muscle spasm with no pain in legs worse in left leg - [ ] Tight muscles - [ ] Super weak legs - [ ] Heart fluttering - [ ] Fatigue - [ ] Continuous twitching through body (in muscles? arm, legs, back, chest, butt, chest) Day 6 - [ ] Tight and sore muscles - [ ] random to continuous twitching throughout body Day 7 Wednesday - [ ] random to continuous twitching throughout body (feels like a fast pulse on and off) - [ ] A few Eye and face twitches - [ ] Tight and sore muscles - [ ] Heart fluttering Day 8 -11 - [ ] random to continuous twitching throughout body (feels like a fast pulse on and off) - [ ] Eye and face twitches - [ ] Heart fluttering
36 2021-04-11 ringing in ears dizzy buzzing in ears and lightheaded. Allowed to rest in EMS room and discharged in stable conditio... Read more
dizzy buzzing in ears and lightheaded. Allowed to rest in EMS room and discharged in stable condition home.
36 2021-04-12 eye strain, visual impairment, dry mouth got second vaccine 3 days ago. Second night I had fever, extreme sweating and nightmares. Woke at 5a... Read more
got second vaccine 3 days ago. Second night I had fever, extreme sweating and nightmares. Woke at 5am today and had what I can only describe as vertigo? Could not balance, did not have control of my legs which were wobbly tensed and shaking. Vision is off room spinning and hallucinating. My dogs shoulders were made of wood boards my partners eyes were black marbles and the room I was in I did not trust to be real or even existing (I was in my bedroom in my apartment I?ve lived in for over a year). It?s now 9am and still difficulty walking with wobbly tensed legs, dizzy, heavy eyes, and one nausea and cotton mouth. This is terrifying
36 2021-04-12 deafness, ringing in ears Random bouts of hearing loss followed by loud ringing in the ear. It subsides fairly quickly but has... Read more
Random bouts of hearing loss followed by loud ringing in the ear. It subsides fairly quickly but has happened 3 times in less then 24 hrs of receiving the shot. Never dealt with this before
36 2021-04-12 hearing loss Nausea, dizziness, fatigue, head spins, sounds echoing in ears, dazed
36 2021-04-12 mouth numbness chest burning, nausea, swallowing difficulty, lip numbness
36 2021-04-12 mouth tingling 37 yo W F came to EMS provider stating that she felt light headed and felt tingling at the back of h... Read more
37 yo W F came to EMS provider stating that she felt light headed and felt tingling at the back of her tongue. Observed patient for several minutes, sensation did not resolve. Pt brought to eval are and Medical Supervisor was call to speak with patient about the second vaccine. Pt was told that the DOH would call her when an appointment time was determined. Pt will be sent to higher level of care for second vaccination. Pt released tp home without any treatment in stable condition.
36 2021-04-12 ringing in ears increased seizure activity; I had the normal yet severe side effects of sore arm & neck; I had the... Read more
increased seizure activity; I had the normal yet severe side effects of sore arm & neck; I had the normal yet severe side effects of sore arm & neck; stiffness behind the ear, stiffness of the neck; stiffness of the neck and injection site arm; fatigue; fever; headache; sore throat; chills; I started suffering from tinnitus; dizziness; nausea; confusion; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the second dose of BNT162B2 (Lot Number: EN6208) via an unspecified route of administration, administered in left arm on 21Mar2021 14:45 (at the age of 36-year-old) as single dose for COVID-19 immunization. Medical history included epilepsy and asthma. The patient is not pregnant. Concomitant medication included levetiracetam. No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (Lot Number: EN6203) administered in left arm on 28Feb2021 14:30 (at the age of 36-year-old) as single dose for COVID-19 immunization. The patient had the normal yet severe side effects of sore arm & neck, stiffness behind the ear, stiffness of the neck and injection site arm, fatigue, fever, headache, sore throat, chills, for the first few days her 2nd dose. But on day 2, she started suffering from tinnitus, dizziness, nausea, confusion in both ears and increased seizure activity. The events started about 2 days after the second shot on 23Mar2021 12:00 PM; its been a week now and it still hasn't gotten better or gone away. She had an appointment with her pcp tomorrow but so far nothing has helped. Its debilitating and extremely hard to focus & function. She mainly just wanted to know if any other vaccine trial participant/recipients have reported anything similar & if so, how long can she expect this to last. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was not recovered.
36 2021-04-12 vision blurred Client received the COVID vaccine (Pfizer, lot # ER8731, expiration date 7/2021) at 11:15. Client w... Read more
Client received the COVID vaccine (Pfizer, lot # ER8731, expiration date 7/2021) at 11:15. Client walked up to the EMT desk and reported dizziness and blurry vision, EMT and RN responded at 11:28. The client returned to her seat, ambulating with a steady gait, no visible distress, color normal. Vital signs obtained: blood pressure 122/78, heart rate 88, respiratory rate 12, O2 level 99%. Client stated she experiences these symptoms before she gets a migraine. The client stated that migraines are her only medical condition, she has no prescribed medications and no allergies. The client was alert and oriented and had no difficulty breathing. The client stated she hadn't eaten yet and just had a drink of water at 0740. She refused water and benadryl. At 1133, the client stated that she felt "totally fine" and wanted to leave. Encouraged the client to stay for 30 minutes from her symptom onset but she deferred. Education provided regarding mobile reporting system, emergency management and AMR activation, and primary care follow up. Client denied questions and left at that time, ambulated with a steady gait to her car.
36 2021-04-13 deafness Loss hearing in my left ear this morning.
36 2021-04-13 hearing loss, ringing in ears, ear discomfort On 30Mar around 2pm, I had sudden onset of pressure in my right ear, tinnitus, and a feeling of dimi... Read more
On 30Mar around 2pm, I had sudden onset of pressure in my right ear, tinnitus, and a feeling of diminished hearing. The tinnitus was constant for approximately 12 hours and then became intermittent. I was seen by my otolaryngologist on 1Apr and had a hearing text and exam with no findings. The symptoms resolved on 3Apr
36 2021-04-13 feeling of choking Pt stated as she was walking out of facility 20 mins after injection, her upper torso and throat fel... Read more
Pt stated as she was walking out of facility 20 mins after injection, her upper torso and throat felt tingly. she was transported via wheelchair to observation where she was examined and placed on bed. VS at 1042 am- BP 146/90; pulse 70, resp 20, O2 100%. Pt given cold water which she tolerated; throat had no signs of swelling or redness at any time. VS @11:15 a.m.-BP 134/86, pulse 65, resp. 16; O2 98%; VS at 11:25 a.m. standing after ambulating 10 feet - BP 127/79, pulse 72, resp 16, O2 98. Pt states she is feeling ready to go home with husband who is accompanying her. Transported to exit via wheelchair and advised to inform PCP of event.
36 2021-04-14 smell distorsion Smell: many things have a very bitter/chemical-like smell since receiving vaccine.
36 2021-04-15 ear pain Patient received first Pfizer COVID vaccine with subsequent shortness of breath, subjective throat s... Read more
Patient received first Pfizer COVID vaccine with subsequent shortness of breath, subjective throat swelling and ear pain/itching. Patient was taken to the ED for ongoing evaluation and is taking 50 mg of Benadryl, IV fluids, 125 mg of methylprednisone, and 20 mg famotidine followed by reevaluation. Patient had no additional symptoms and discharged.
36 2021-04-15 lip swelling awoke with swollen face and lips; awoke with swollen face and lips; itchy, red rash began on arms an... Read more
awoke with swollen face and lips; awoke with swollen face and lips; itchy, red rash began on arms and spread to torso and legs by evening/full body red, itchy rash; itchy, red rash began on arms and spread to torso and legs by evening/full body red, itchy rash; full body aches; joint pain; fatigue; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9810), via an unspecified route of administration administered in right arm on 05Feb2021 at 12:15 (at the age of 36 years-of-old) at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included (sertraline hydrochloride) ZOLOFT, (cyanocobalamin) VIT B12, (colecalciferol) VIT D3 and multivitamins. The patient previously received first dose of bnt162b2 in right arm on 15Jan2021 at single dose for COVID-19 immunisation. On 06Feb2021, the patient experienced full body aches, joint pain and fatigue. On 08Feb2021, the patient experienced itchy, red rash began on arms and spread to torso and legs by evening/full body red, itchy rash. On 09Feb2021, the patient had full body red, itchy rash and went to urgent care and received prescription for topical steroid. On 10Feb2021, the patient awoke with swollen face and lips. The swelling subsided within 1 hour of waking, but full body itchy, red rash persisted. The patient had very little relief from creams or medication. On 11Feb2021, the full body itchy, red rash persisted. The patient spoke to staff that administered the vaccine and was told to see additional care if rash is not resolved by Monday. On 12Feb2021, the rash has improved with the help of ibuprofen and time. Itchiness returns once ibuprofen wears off. The patient did not take any other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. The outcome of the events full body aches, joint pain and fatigue was recovered on 07Feb2021 and the event awoke with swollen face and lips recovered on 10Feb2021. The outcome was recovering for the rest of the events.
36 2021-04-15 tongue itchiness, mouth numbness Tongue and lip numbness since Thursday morning at 1am I took a Claritin at that time and same Friday... Read more
Tongue and lip numbness since Thursday morning at 1am I took a Claritin at that time and same Friday morning at 1am; however tongue itching and hives on tongue persist
36 2021-04-16 loss of taste Loss of taste 18 hours post-injection (still has not fully returned 23 days later - I did have COVID... Read more
Loss of taste 18 hours post-injection (still has not fully returned 23 days later - I did have COVID in December 2020 and loss taste and smell for many weeks, did not expect it to happen again after my first injection) Swollen lymph nodes in left arm pit 24 hours post-injection (recovered after 5 days of inflammation/pain)
36 2021-04-16 eye irritation Total body Itching/Hives, Flushing/Sweating, Eye irritation. BP 158/93, O2 100%, pt A&Ox5. Pt give... Read more
Total body Itching/Hives, Flushing/Sweating, Eye irritation. BP 158/93, O2 100%, pt A&Ox5. Pt given IM Benadryl 50mg and transported via w/c to ED.
36 2021-04-16 mouth discomfort Burning all over body and mouth
36 2021-04-16 taste disorder Complete change of taste 2 hours after the shot administration: 1. No taste for glucose (e.g. doesn'... Read more
Complete change of taste 2 hours after the shot administration: 1. No taste for glucose (e.g. doesn't feel sugar in candies or cookies), but feels fructose in fruits 2. Sour taste after milk products 3. Sour products became less sour (e.g. can eat lemons and does feel sugary taste there) 4. Almost no taste for vegetables
36 2021-04-19 blindness Pt had symptoms of dizziness, lost of sight, low blood pressure, weakness, and tingling feeling arou... Read more
Pt had symptoms of dizziness, lost of sight, low blood pressure, weakness, and tingling feeling around her body. She was sweaty and felt clammy. She stated that she feels hot all over.
36 2021-04-19 ear pain, ringing in ears, deafness unilateral, ear discomfort Constant Tinnitus began in left ear the night I received the Covid-19 Vaccine shot. After a couple o... Read more
Constant Tinnitus began in left ear the night I received the Covid-19 Vaccine shot. After a couple of days more symptoms appeared, including: Left ear fullness/pressure/inflammation feeling, left ear numbness, left outer ear tightness, shooting nerve pain in into left ear (outside and inside ear), shooting nerve pain towards the scalp on left side, extreme cramping inside and outside left ear. The tinnitus alternates between loudness of 2-7, at worst its a high pitched ringing noise, at best its a hissing noise. Often also a whistling noise, crackling noise, sleigh bell noise, occasionally pulsatile. Also have increased anxiety due to the tinnitus. Audiologist confirmed unilateral hearing loss in left ear in the Ultra high frequency hearing range (35db at 10K Hz, 60 dB at 11.2K Hz, 50 dB at 12.5K Hz, 40 dB at 14K Hz, and 35 dB at 16K Hz). Audiologist recommended practicing Mindfulness and listening to classical music, so as to not be in quiet environment, where I might focus more on the ringing in my ear. Taking supplements including: Multi-Vitamin, Iron supplement, Vitamin D3, Vitamin B Complex, Alpha Lipoic Acid, Bio-Flavonoids, Systemic enzymes, Benfotiamine, Turmeric. Currently 3.5 weeks later, I still have tinnitus, but it is usually at a volume of 3 or 4. It more often is hissing noise with alternating high pitched ringing. The ear fullness, numbness and nerve pain is less, but still there. ENT PA prescribed Methylprednisolone 7 day tapered dose on 4/15/2021 to take if painful symptoms of nerve shooting continue or get worse. Nerve shooting pains improved slightly, so as of yet have not begun the methylprednisolone. Anxiety has improved with use of Classical Music and Mindfulness. Also found a Facebook Group of those suffering tinnitus after the Covid-19 vaccine, and have found support there to cope.
36 2021-04-19 mouth tingling, mouth numbness tingle, numbness on left hand. Initially the two middle fingers, but then spread to entire hand. S... Read more
tingle, numbness on left hand. Initially the two middle fingers, but then spread to entire hand. Same sensation on the right side of face that started on lips. Lasted about 10 minutes.
36 2021-04-20 tongue disorder, lip swelling One and a half hours after vaccine was administered my face started to feel numb and tingly and my l... Read more
One and a half hours after vaccine was administered my face started to feel numb and tingly and my lips began to swell. Benadryl 50mg was administered with good results. About an hour after the Benadryl was administered my face and extremities began to feel numb and tingly and my tongue felt thick (I couldn't talk clearly) and my face began to swell. I was then taken to the medical office across the street for additional treatment. My vitals were taken and my blood pressure was elevated, I was taken to a room and Benadryl and a steroid was administered SubQ and I was prescribed an oral steroid as well. I continued to have swelling and numbness for five days and I had to take Benadryl every four hours for those five days.
36 2021-04-21 taste disorder, dry mouth Patient complained about coldness to her upper body and behind her neck as well as a funny taste in ... Read more
Patient complained about coldness to her upper body and behind her neck as well as a funny taste in her mouth. She was released about 45 minutes later after she reported feeling much better but did have a dry mouth and funny taste still.
36 2021-04-22 mouth numbness Tingling sensation down arm of injection(felt like tiny robots in my arm) itchy throat, and numbness... Read more
Tingling sensation down arm of injection(felt like tiny robots in my arm) itchy throat, and numbness in left side of mouth/tongue.
36 2021-04-22 visual impairment I received my second vaccination around 10:00 AM. I waited 15 minutes in the pharmacy to make sure ... Read more
I received my second vaccination around 10:00 AM. I waited 15 minutes in the pharmacy to make sure I didn't have any negative reactions before leaving. I felt fine at 15 minute mark. As I was driving home, I did feel a little off and my arm was a little sore on injection side. All of a sudden, out of nowhere, my vision started to turn black starting from outside and tunneling in while I was driving 35 mph. I didn't have much warning that I was going to black out but I did. Before blacking out I tried to put my car in park out of reflex while going 35 then everything went dark. When I awoke I thought I was going to wake up in bed. I had a whole dream but realized quickly I was in my car then everything came back to me. Instead of the car being in park it was in reverse and I reversed the car into two other cars on the road. Luckily no one was hurt. I am very shaken up. I am a healthy 36 year old and tolerated first does just fine. People need to have others drive them after receiving vaccination. If I was on the highway or had my kids in the car things could have been much different.
36 2021-04-23 sensitivity to light Severe migraine started about 2 days after both first (3/27/21) and second (4/17/21) doses of Pfizer... Read more
Severe migraine started about 2 days after both first (3/27/21) and second (4/17/21) doses of Pfizer vaccine. Migraine lasted about 4 days in both cases and did not subside with normal prescription treatment (Sumatriptan, 50 or 100 mg). Symptoms: Head pain, sensitivity to light and sound, nausea, extreme fatigue.
36 2021-04-23 swollen tongue Right side of throat swelling, tongue swelling, and hives on face, neck, and chest.
36 2021-04-23 swollen tongue Swelling in throat, slight tongue swelling, and hives in face, neck, and chest.
36 2021-04-24 ear pain, ringing in ears tinnitus (buzzing in the left ear) ear pain
36 2021-04-24 mouth tingling, feeling of choking Tingling at injection site, throat, and tongue. Benadryl and solumedrol given. Released with husband... Read more
Tingling at injection site, throat, and tongue. Benadryl and solumedrol given. Released with husband in stable condition.
36 2021-04-25 lip swelling Client recieved first dose of Pfzier vaccine on 03/31/2021 at 10:30 am. By 3:00 pm on 3/31/21 the cl... Read more
Client recieved first dose of Pfzier vaccine on 03/31/2021 at 10:30 am. By 3:00 pm on 3/31/21 the client stated her face was "red and puffy" Client stated lip swelling as well. Lip and face swelling subsided by evening. Client has no history of dermal fillers. Face redness continued until the next day, 04/01/21. With all facial redness resolving by the afternoon. Did not seek medical care for event.
36 2021-04-25 vision blurred, sensitivity to light, visual impairment Had vaccine, first feeling the cold, and stayed on the couch. Then a burning sensation was felt in ... Read more
Had vaccine, first feeling the cold, and stayed on the couch. Then a burning sensation was felt in her legs and throughout her body. She felt hot/burning sensation. She took off her clothes as she had that sensation to feel more comfortable as she felt the clothes felt like pins and needles. Then she had problems falling to sleep. Her arm was hurting as well, and then had a mild headache. She woke up early around 5:00 AM, and her arm was hurting to the ponit that she could lift it. She had pain in the muscles of her legs, thighs, calf and then her stomach started aching, and her whole body was aching. The arm was still unable to move, headache, and stayed in the bed all day, was very very tired as well. The next day she felt so tired, stayed in bed, body aches, headache, and then she started noticing her vision was going. Very very blurry vision on 4/21/21, and sensation to the light. She was this way all day Wednesday and still problems on the light. On 4/23/21, she was still tired, her arm was not hurting as much. When she woke up her extremities were shaky. Today her arms are shaking, her vision was tweeking and she could feel it, and also the headaches. She called her doctor on the 24th, and told him her symptoms. Her vision is bad to the point that she cannot use her phone as she cannot see, focus well and has blurry vision. Yesterday at 4:00 Am she went to the hospital and they kept her over night. They ran blood work, then they took an MRI of her brain, head MRI, and did not see anything of concern and told her to FU with a Neurologist. to have further tests done but as she is pregnant (5-6) weeks they would probably have to wait. Some of her side effects are still there, but has nausea and feels that her vision continues to be bad, and daily she wakes up and is worsening. She has slight dizziness, and headaches, and feeling shaky. She has not seen her doctor as far as her pregnancy yet, but has an APT on 6/10/21. She has an APT to see her PCP on Friday, 4/30/21 at 9:00 AM.
36 2021-04-26 loss of taste, loss of smell Received Pfizer vaccine on 1/15/21 and 2/5/21. On 4/21/2021 developed loss of taste/smell, rhinorrhe... Read more
Received Pfizer vaccine on 1/15/21 and 2/5/21. On 4/21/2021 developed loss of taste/smell, rhinorrhea, headache, sore throat, nausea/vomiting and fatigue. Tested positive for COVID.
36 2021-04-26 ringing in ears, deafness unilateral, permanent deafness Hearing loss (right ear), ringing in ear, vertigo, diziness, numbness in my head, pins and needles ... Read more
Hearing loss (right ear), ringing in ear, vertigo, diziness, numbness in my head, pins and needles in my face, arms and legs Diagnosis: Labyrinthitis, Sensorineural hearing loss, BPPV Recomendations: VRT with physical therapy, steroid treatment
36 2021-04-27 lip swelling, tongue itchiness, lip itchiness Patient received first dose of Pfizer around 7:43 AM. Patient observed after vaccine and on her way ... Read more
Patient received first dose of Pfizer around 7:43 AM. Patient observed after vaccine and on her way out felt "her throat feeling thick and itchy". RN brought patient back to med bay. Patient was having difficulty swallowing, and reported throat and tongue itchiness. 50 MG IM Benadryl given at 0813. DOC on call notified at this time. Patient reported symptoms improved after Benadryl, but about 6 minutes later, they came back and felt "worse". Patient was holding her throat, was struggling to swallow, was coughing, and felt SOB. Patient was having difficulty completing a full sentence. Epi pen given at 0823 and 911 called. Patient hospitalized in the past due to anaphylaxis with shellfish. RN monitored patient until EMS arrived at 0837. During that time, patient reported improved symptoms, but still felt it was a little difficult to swallow. Patient awake and alert speaking in full sentences at this time. Denies SOB and VSS. When EMS arrived, patient's symptoms returned and she stated "my throat and muscles in my neck feel swollen and tight. My lips and tongue are itchy and thick". EMS gave another EPI dose at 0847 and transported patient to hospital. Patient was awake and alert prior to transport. EMS arrived on scene at 0837, administered another dose of EPI and transported patient to Hospital.
36 2021-04-27 ringing in ears Injection went fine, no pain or anxiety. Walked about 50 feet, immediate flushing and dizziness, tin... Read more
Injection went fine, no pain or anxiety. Walked about 50 feet, immediate flushing and dizziness, tingling skin. Almost fainted; had to lie down. Blood pressure fluctuated. Twitching muscles, strong body shakes, chattering teeth. Lasted about an hour and a half after injection. Given benadryl. Clinic recommended ER visit. By time arrived at ER, symptoms subsided. Day after - injection spot pain, headache, high anxiety and panic attack, ringing in ears. Day 2 after - twitching muscles, high anxiety and panic attack, headache, fatigue, body aches, diarrhea.
36 2021-04-28 ear discomfort Recurring vertigo and dizziness. Vertigo started 3 days after vaccine, returned 4 days after first ... Read more
Recurring vertigo and dizziness. Vertigo started 3 days after vaccine, returned 4 days after first spell, and have been feeling slighly dizzy for the next few days. Had another vertigo spell today, which was brief. I feel a bit dizzy with pressure on left ear and head. I suffer from seasonal allergies.
36 2021-04-29 dry mouth Spoke with pt this morning. She got her 1st Covid vaccine at 10:15. She left at 10:25, said room was... Read more
Spoke with pt this morning. She got her 1st Covid vaccine at 10:15. She left at 10:25, said room was crowded and she had her 2 year old with her. She reported feeling dry mouth and clammy at 1035. Called Triage at 1109,(copied from Triage note): Pt states that she received her first vaccine this am, about 45 minutes ago. States that she is having trouble swallowing, dry mouth, pressure in throat area, hands are clammy, feeling hot. All started just a couple minutes ago, got dizzy and lightheaded. Pt has never had reactions to any other vaccines in her past. As she is talking, she is feeling worse. Taking benadryl now as we speak. RN, 4/28/2021 11:10:16 AM > Pt is going straight to urgent care now, husband is driving. She has taken benadryl. Aware to call 911 if trouble breathing prior to arriving to urgent care. Will be calling pt back to check on her later today. Pt did not go to Urgent care as instructed, she went home and started to drive to Hospital. She reported being a mile away from her house and felt her tongue swelling and poor vision. She called 911, was given epinephrine in car, prednisone and benedryl. Transported to Hospital and was observed for 4 hrs. Pt asking if okay to take Prednisone, trying to concieve and should she get 2nd vaccine? MD, 4/29/2021 11:19:40 AM > Should not get second vaccine. Ok to take the prednisone taper as rx'd.
36 2021-04-29 taste impairment Sweet taste in mouth, Exhaustion, body aches, fever, arm pain, mild pain in chest left side under th... Read more
Sweet taste in mouth, Exhaustion, body aches, fever, arm pain, mild pain in chest left side under the last rib. All this started on day of vaccine through the night and into the morning I still feel bad.
36 2021-04-29 eye disorder 11.20 am March 31st 2021 ? Pfizer first dose Around 4.30 pm ? severe headache, feeling like in an un... Read more
11.20 am March 31st 2021 ? Pfizer first dose Around 4.30 pm ? severe headache, feeling like in an unfamiliar environment, low-grade fever, muscle pain Took ibuprofen around 4.30 pm, took Tylenol after 8 hours, took Tylenol in 12-hour gap for two days After about 30 hours, symptoms went away. Had headaches occasionally. 8.10 pm April 8th Eyesight declined to a certain limit; Eyesight was similar for both eyes. Waited for about 10 minutes hoping it would go away. Started feeling right arm was numb and after some time left side of the head including the ear was aching. Got medical help after about 5 minutes. Nothing was found wrong in the preliminary checkup. Taken to the emergency room. Could remember all the basic information. Had difficulties recalling past incidents and correlating things. Could think only about one thing at a time when making decisions. Could not relate things well. After coming home, realized that I had taken extra effort when talking as my tongue moving was quite resistant. Had headaches few times and took Tylenol. Had a headache and took the medication given at the ER. It did not help much. April 13th Went to see the doctor as instructed by the emergency room. Asked to start taking aspirin 2 days prior to second vaccine and continue for 5 days after vaccination 4 pm April 14th Was lightheaded for few hours. Took aspirin before bed. Had a severe backpain throughout the night. Morning April 15th Took Tylenol as body was paining and it did not help much. Contacted health center. Was asked to get a Covid test done. April 16th ? felt better April 18th ? Started feeling like my usual self again. Felt fit again. April 19th Went to see the doctor at the health center. Felt tired after walking a short distance. Unusual for me. Covid test was negative and another test was done to check whether I has another viral infection and the test turned out to be negative. April 20th- April 21st When recalling things in my work, I realized few times that I cannot think properly. April 21st I was felt healthy throughout the day but got exhausted by the end of the day without doing much work. Got a severe headache and took two aspirins around 9 pm before bed. Woke up around 12.30 pm. Could not go to sleep for about 3 hours as I felt so warm and I was restless. Lot of negative feelings were coming to my mind. April 22nd Got up around 7 am. So tired and the whole body was aching. Took Tylenols as I still had the headache and headache except body aches were gone by 1 hour. I had fatigue by the end of the classes. Before classes, I was trying hard to understand the material. Though I could read those familiar problems, I could not understand the concepts easily. When doing classes, I was just reading the answers of the problems. I was trying hard to correlate things as I felt like my brain was not cooperating with me making familiar concepts unfamiliar to me. Towards the end of the day, I could correlate things and think properly though I was still tired. After about 6 pm, I started feeling fit again though there were body aches. I have taken aspirin about twice within a three-year period. To my knowledge, no problems occurred. Though my second dose was scheduled to April 22nd, I did not take the second dose as I was not feeling well even after 3 weeks. After about one month taking the first dose, I was feeling better. Specifically, I felt that my thinking was not clear for the past 4 weeks.
36 2021-04-29 eye pain Pain in left eye and eye socket. Ache when moving pupils to lateral extremities. No impact to vision... Read more
Pain in left eye and eye socket. Ache when moving pupils to lateral extremities. No impact to vision or headache. onset was 36 hours after vaccine.
36 2021-04-30 mouth numbness lightheadedness, confusion feeling out of body. Numbness in my fingers, my feet, my lips and tongue.... Read more
lightheadedness, confusion feeling out of body. Numbness in my fingers, my feet, my lips and tongue. It comes and goes mostly when I eat food, then I feel numbness. It is a very scary.
36 2021-04-30 lip swelling Swollen lips, Severe headache, chills, weak, body aches
36 2021-04-30 oropharyngeal discomfort, inability to speak Voice is completely gone; Throat was feeling like closed and stuff; Throat felt like closing, it com... Read more
Voice is completely gone; Throat was feeling like closed and stuff; Throat felt like closing, it completely actually closed because I am able to talk and breath and 'all the other stuff' but I lost my voice; Throat was feeling like closed and stuff; Throat felt like closing, it completely actually closed because I am able to talk and breath and 'all the other stuff' but I lost my voice; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 36-year-old on 11Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient said she was calling because she had her Pfizer first vaccine on sunday and then she started having like her symptoms which was like her throat was feeling like closed and stuff like that in Apr2021. She received her Pfizer shot on Sunday morning and now today it's Tuesday (on 13Apr2021) and her voice was completely gone. The symptoms that she was having was that her throat felt like closing, it completely actually closed because she was able to talk and breath and 'all the other stuff' but she lost her voice and it wasn't one of the actual side effects that was listed on the paper that she receive, when she received the first dose of vaccine. When confirmed if it was the first shot or second, consumer stated, this was her first shot she got it, and she received it on Sunday, the Sunday which just passed. It was just Sunday, it was 11th. She received her shot on 11th which was Sunday. The patient stated, Yes, she just need to know if it was one of the actual side effect that they didn't put on the actual paper work, was this actual comment or actual side effect of her receiving her actual shot. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
36 2021-05-01 ringing in ears, ear pain I had no reaction to the first vaccine apart from a sore arm. After vaccine #2, I experienced fairly... Read more
I had no reaction to the first vaccine apart from a sore arm. After vaccine #2, I experienced fairly normal side effects (low-grade fever, flu-like body aches, chills, fatigue, sore arm) that lasted for less than 24 hours. The side effects completely subsided and a few days later, I noticed some ear pain in my left ear that came on suddenly. It was gone around 30 minutes later and I didn't think much of it. The next day, I noticed a faint white noise/ringing in my ears, which has now been consistent for over two weeks. I visited an ENT who cleared my ears of wax and he noted that my ears otherwise looked fine, no infection. They tested my hearing, which was also normal. But the tinnitus has continued. I have never had an issue with tinnitus in the past, have not had Covid-19, and am careful with my hearing. A quick google search reveals that many other people have the same complaint after receiving the vaccine (or, after being infected with Covid).
36 2021-05-01 ringing in ears Tinnitus in both ears for the last week and a half or so. This adverse event is ongoing. Swollen ly... Read more
Tinnitus in both ears for the last week and a half or so. This adverse event is ongoing. Swollen lymph nodes in neck, armpits, and groin immediately after vaccination, lasting around one week. Patient recovered from this adverse effect.
36 2021-05-02 taste impairment 5/1/2021 Drainage and weird taste in back of mouth 11:30a Slight redness left thigh warm to touch 12... Read more
5/1/2021 Drainage and weird taste in back of mouth 11:30a Slight redness left thigh warm to touch 12:30-1:15p Fatigue 12:30-current Nausea 12:30-current Headache 3:15-current Diarrhea 4:30-current Sore arm 8p-current General malaise, especially if standing up 9:30p-current Face pressure 11:30p-11:35p 5/2/2021 Shakes 5a-7a Chest pains 8a-current, intermittently Anal bleeding 2p, every bowel movement since, bright reed blood in toilet and on paper Lightheaded and faint called EMS Blood pressure 155/94 3p, they suggested to follow up with my PCP in AM Anal bleeding 5:30p Red streak R arm near injection site 6:15p-6:45p Red dots on L knee 6:15p-current (not itchy) Started period/spotting 1st one since conceiving last year. I am 12 weeks postpartum and exclusively breastfeeding. (light brown not heavy) 9:30p (with prior two children J did not start my period until babies were about one year old and weaning from breastfeeding)
36 2021-05-02 eye itchiness Flushing/sweating, swelling of throat ("tightening, itchiness"), itchy eyes. Given Benadryl 50 mg PO... Read more
Flushing/sweating, swelling of throat ("tightening, itchiness"), itchy eyes. Given Benadryl 50 mg PO x1. Resolved, patient stable, released from vaccination site.
36 2021-05-02 mouth tingling 2:45pm, 18hours after vaccination, I started to feel unwell. A cold front came in and started a bad ... Read more
2:45pm, 18hours after vaccination, I started to feel unwell. A cold front came in and started a bad what I thought was a fibromyalgia flair up. Muscle pain. I was in severe pain until 4pm when things started going down hill. Muscles were tight all over my body including muscles pulling on my chest. I would describe as pulling heart apart from both sides. Muscles stiff. Torso filled with knots. Hyperventilating. Extreme muscle pain. Pain to where I could not stay still. I had on a blood oxygen reader. My blood oxygen number dropped to 64 and my pulse dropped to 38. My lips nose fingers toes and whole right side all the way down my leg were tingling .My husband did not tell me the numbers as he did not want to frighten me as I was already panicked. This lasted a half hour. I took my xanax and muscle relaxer. Not sure if this is what helped bring me out of it. Ok at 5pm. Started feeling unwell again at 9:45pm. Took bedtime med and went to sleep and was able to sleep it off. If i knew my numbers were that low I would have had my husband call 911 Felt similar to suspected covid case before tests were available to public. Mar/April 2020
36 2021-05-04 swollen gums, lip blister, bleeding gums, lip swelling Lower lip was (and still is) swollen, is painful, some puss is oozing, and is blistering, gums start... Read more
Lower lip was (and still is) swollen, is painful, some puss is oozing, and is blistering, gums started bleeding and became swollen (swelling of gums has gone down, however the gums are still painful).
36 2021-05-04 mouth tingling patient started having bells-palsy like symptoms- lips and right side of the face tingled and loss m... Read more
patient started having bells-palsy like symptoms- lips and right side of the face tingled and loss motor control
36 2021-05-04 ringing in ears Tinnitus. Primary doctor care, antibiotics. Anxiety, panic attack. Emergency room care. Mental healt... Read more
Tinnitus. Primary doctor care, antibiotics. Anxiety, panic attack. Emergency room care. Mental health inpatient/outpatient. Daily anti anxiety medication. ENT doctor visit. Hearing test. Audiologist visit, hearing test. Chiropractic care. No change in symptoms.
36 2021-05-04 tunnel vision Pt brought to med obs #1 via stretcher for c/o dizziness, generalized tingling, diaphoresis, tunnel ... Read more
Pt brought to med obs #1 via stretcher for c/o dizziness, generalized tingling, diaphoresis, tunnel vision and brief LOC prior to stretcher arrival. Pt reports he "came to" almost immediately after experiencing tunnel vision and refused to lie on floor with BLE elevated prior to stretcher arrival. Pt ambulatory without difficulty. Accepted water, declined snack, states he ate breakfast PTA. VSS. No s/s of distress noted. S/O at bedside. Escorted to exit with staff. VS are as follows: 1140: BP 166/99, HR 100, RR 20, O2 sat 98% on RA 1145: BP 149/98, HR 91, RR 18, O2 sat 98% on RA
36 2021-05-05 lip swelling, swollen lips Pt had the Vaccine May 1st and the next morning woke up with lower lip swelling and a small sore in ... Read more
Pt had the Vaccine May 1st and the next morning woke up with lower lip swelling and a small sore in center of her lip. Pt is now having yellow discharge from the sore.
36 2021-05-05 ringing in ears tinnitus that hasn't subsided, worse in the mornings around 9:00am-12:00pm, worse at night while lyi... Read more
tinnitus that hasn't subsided, worse in the mornings around 9:00am-12:00pm, worse at night while lying down
36 2021-05-05 vision blurred Blurred vision Headaches Leg cramping Dizziness Body aches Chills Falling
36 2021-05-06 mouth lesion, lip swelling stiffness in her neck; pain neck; rash all over her neck/rash has gone on to her face; breaking out ... Read more
stiffness in her neck; pain neck; rash all over her neck/rash has gone on to her face; breaking out in hives through out her body; lip is swollen; bumps underneath her lip; rash is going inside her mouth; This is a spontaneous report from a contactable consumer (patient). This 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8731, expiration date 31Jul2021, on 14Apr2021 at single dose for COVID-19 immunization. Family history included lupus, COPD, diabetes which her mother had and she basically got it so she could be around her mother. Concomitant medication was none. The patient had the shot last Wednesday (14Apr2021) and then by Saturday (17Apr2021) she had severe neck pain and stiffness in her neck, she couldn't move her neck. The pain was ongoing. She had no rash on her arm but she had rash all over her neck and she went to the doctor and they gave her a steroid shot because they thought maybe it could be something different. She had the steroid and she still breaking out in hives through out her body. They gave her a steroid shot on Monday (19Apr2021) but the rash had gone on to her face, her lip was swollen, there were bumps underneath her lip and the rash was going inside her mouth and even though she got the steroid shot she was still breaking out in new hives. She said she was going to have to go and go back to work she thought this was going to be quick and it was not. She did not have the name of the steroid injection or have a lot expiration to provide. They also gave her Naproxen for the stiffness in her neck and a muscle relaxer. The outcome of stiffness in her neck, pain neck and rash all over her neck/rash has gone on to her face was not resolved. The outcome of other events was unknown. No follow-up attempts are possible. No further information expected.
36 2021-05-06 swelling of eyelid Left eye lid has been red, swollen, and painful since 7:30 PM on 5/5/21; inside left armpit swollen ... Read more
Left eye lid has been red, swollen, and painful since 7:30 PM on 5/5/21; inside left armpit swollen but not painful since 7:00AM on 5/7/21
36 2021-05-07 mouth lesion, eye swelling Rash around mouth, nose, eyelids, swollen left eye- resolved by day 7. Left arm muscle spasms, elec... Read more
Rash around mouth, nose, eyelids, swollen left eye- resolved by day 7. Left arm muscle spasms, electrical shock sensations, numbness tingling, weakness, loss of ROM, nerve pain involving all brachial plexus muscle groups. Moderate sever for 2 months post injection. Persistent mild to moderate loss ROM, weakness, pain left arm from day 2 post injection to present.
36 2021-05-09 loss of taste URI, LOSS OF TASTE , SORE THROAT
36 2021-05-09 lip dry 6 days later- low back pain, strange headaches, rash of blisters on my left face from the lower lips... Read more
6 days later- low back pain, strange headaches, rash of blisters on my left face from the lower lips to my nose. My lips are completely dried out and raw like all the skin is peeling. Severe fatigue.
36 2021-05-09 ringing in ears Whooshing/ringing/machine noise in left ear that is persistent and has not faded
36 2021-05-10 eye swelling, swelling of eyelid Woke up in middle of night with swollen eyes /bumps on eyelids and itchy redness on chest
36 2021-05-10 sensitivity to light, pupils dilated, visual impairment her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding... Read more
her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding; her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding; headache; light sensitivity; vision changed; extreme fatigue /Exhaustion; overall body aches; sweaty /Sweating Profusely; her pupils were dilating and constricting; her pupils were dilating and constricting; Brain Fog; This is a spontaneous report received from a contactable consumer (patient). The consumer reported information for both mother and baby. This is the maternal report. A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Apr2021 at age of 36 years at single dose for COVID-19 immunisation. Medical history included ongoing asthma, had basically had all of her life; since she was about 8 years old. Her grandfather had strokes. Her father died of a heart attack. Patient had no concomitant medications. Patient received her first Pfizer Covid vaccine dose on 20Apr2021. She stated that after the vaccine was administered (on 20Apr2021), she started to experience extreme fatigue and needed to sleep. After waking up from a nap, she noticed vision changed, headache with light sensitivity, overall body aches, and sweaty. Her husband told her that her pupils were dilating and constricting. Her MD advised her to go to the ED. Patient stated why the patient taking covid vaccination was asthma, medical worker and having a 9-month-old baby. Patient stated that she had been experiencing vision problems and a severe headache. Said her pupils had been dilating and contracting. Patient had severe headache, vision problems; pupils keep dilating and contracting, exhaustion, brain fog, sweating profusely on 20Apr2021. Said her symptoms started yesterday 20Apr2021, stopped, and then started again today. Stated she had questions about her side effects and asked should she go the Emergency Room; especially for the headache. Said today they were just as bad as yesterday; except she was not as exhausted today as she was yesterday. Patient stated that her main reason was because her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding. Patient denied any medications, labs, testing, or treatments relevant to report. AE(s) did not require a visit to Emergency Room and Physician Office. Patient stated no adverse events after prior vaccinations; only an antibiotic. Outcome of exhaustion was recovering and the other events was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446591 Same reporter/drug, different patient/event (baby case)
36 2021-05-11 ringing in ears Tinnitus, continuous bilateral. Evaluation by primary care doctor and then referred to ENT and audio... Read more
Tinnitus, continuous bilateral. Evaluation by primary care doctor and then referred to ENT and audiology. No otherwise evident cause from examination and testing.
36 2021-05-12 vision blurred I was putting my son to sleep and I fell asleep for about 10 minutes. When I woke up my vision I was... Read more
I was putting my son to sleep and I fell asleep for about 10 minutes. When I woke up my vision I was unable to see clearly from my right eye. It was extremely blurry. It lasted for about 2-3 hours at which point I went to sleep. When I woke up the next morning my vision was completely restored.
36 2021-05-14 permanent deafness Sudden sensorineural hearing loss in right ear 1.5 months after receiving 2nd dose
36 2021-05-15 dry mouth Chronic diarrhea with no remission since the vaccine. Dry mouth. Dizziness. Chest tightness
36 2021-05-15 eye pain Mild tension headache and mild pain behind the eyes for 24 hrs. Also, general fatigue for 18 hrs.
36 2021-05-15 gaze palsy Headaches, chills, fever (100.5), body pain,
36 2021-05-16 deafness No known effect to baby since it is not due for a few more months. I am only aware of the hearing lo... Read more
No known effect to baby since it is not due for a few more months. I am only aware of the hearing loss I experienced as the pregnant mother I?ve now had two separate bouts of hearing loss. The first started 5 days after the first vaccine and lasted around 36 hours. The second was almost two weeks after that and also lasted around 36 hours. Both times I felt a lot of pressure in my ears and had muffled hearing. I subsequently made an appointment with an ENT that alerted me this could be a vaccine side effect. I have not had my second dose of the vaccine yet.
36 2021-05-16 ear swelling, ear discomfort 6 year old female received the 1st dose of the Pfizer COVID-19 vaccine at facility on 04/17/2021 @ 1... Read more
6 year old female received the 1st dose of the Pfizer COVID-19 vaccine at facility on 04/17/2021 @ 10:30. The same day, 04/17/2021, pt started experiencing pain in the arm at the injection site and fatigue. The pain in the arm resolved in 2 days, fatigue is still occurring. 04/20/2021 pt started experiencing dizziness, vertigo, nasal congestion, ears feel clogged, diarrhea, and paliptations, which are still occurring. Pt went to a hospital on 04/27/2021 and 04/30/2021 and had CAT scan of lungs and head. CAT scans were normal and kidney function was discovered to be low. Pt saw ENT, who stated the ear is swollen and prescribed Promethazine and Vancycovir. Pt is asthmatic and has a UTI. Pt takes Sulfamethoxazole-Trimethoprim, Metronidazole, Meclizine, Promethazine, Valacyclovir, and vitamins. Pt denies any allergies. Pt was advised to consult with ENT in regards to symptoms. SPI was consulted and Dr. was notified.
36 2021-05-16 oropharyngeal discomfort I began to feel like something was stuck down my throat mid-chest area. I also began experiencing b... Read more
I began to feel like something was stuck down my throat mid-chest area. I also began experiencing burning in my chest. When I would eat or drink something it would be painful. I had bile building up in my throat, but never threw up. Being upright was more comfortable than lying down. This happened first during the day, and then two additional times in the evening/late into the night before I called my doctor. I then called my doctor who diagnosed me with an esophageal ulcer. I am currently on medication for the ulcer.
36 2021-05-17 ringing in ears Nausea 72hrs Diarrhea 72hrs Chills 72hrs Cold sweats 72hrs Unable to keep any liquids or foods down ... Read more
Nausea 72hrs Diarrhea 72hrs Chills 72hrs Cold sweats 72hrs Unable to keep any liquids or foods down 72hrs Sore arm 48hrs No energy. 72hrs Ringing sound in head with headache (like TV ringing sound) 72hrs
36 2021-05-18 ringing in ears Hypothermia; Full body muscle ache; Tinnitus; This is a spontaneous report from a non-contactable ot... Read more
Hypothermia; Full body muscle ache; Tinnitus; This is a spontaneous report from a non-contactable other hcp (patient). A 36-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration on 02Apr2021 13:15 (Batch/Lot number was not reported) unknown dosage #, single dose for COVID-19 immunization. Medical history included thyroid disorder and food allergy (artificial color shrimp mango some preservatives) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient experienced hypothermia for few hours, full body muscle ache and tinnitus on 01May2021 with outcome of recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. Medical history of thyroid disorder may provide a plausible alternative explanation for the events. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-05-19 sensitivity to light Within a few minutes after injection patient developed arm pain around the injection site.; headache... Read more
Within a few minutes after injection patient developed arm pain around the injection site.; headache; sensitivity to light, about half an hour after injection.; This is a spontaneous report from a contactable pharmacist. A 36-years-old female patient (non-pregnant at the time of vaccination) received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in Arm Left on 20Apr2021 at 11:30 as first dose single for COVID-19 immunization. Medical history included infertility, menstruation irregular, chronic spontaneous urticaria, insomnia, hypersensitivity (Seasonal allergies with particular allergy to oak and Allergic to dust) and food allergy from an unknown date and unknown if ongoing. Concomitant medications were not reported. Patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. On 20Apr2021 at 11:45 Within a few minutes after injection patient developed arm pain around the injection site. Patient also developed headache and sensitivity to light, about half an hour after injection on 20Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test as negative on 07Apr2021. Treatment was not received. The outcome of the events was not recovered. Follow-up (PRD 26Apr2021): No new AE is available. I am the reporter in this case. Please update reporter email to Awareness date of the initial item is 20Apr2021 as indicated in initial report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
36 2021-05-19 vision blurred, visual impairment Woke up at 7am for work and by 7:15am I began to feel lightheaded, cold, and my vision began to blur... Read more
Woke up at 7am for work and by 7:15am I began to feel lightheaded, cold, and my vision began to blur. Soon after, my I only saw white and then became extremely hold and had short of breathe. I fainted and did not become conscious again until paramedics came around 7:30am. Later that day, I also had a headache that lasted the remainder of the day and light fatigue.
36 2021-05-21 blindness I had recovered about 90% (with medication) since having COVID in December when I received my first ... Read more
I had recovered about 90% (with medication) since having COVID in December when I received my first dose of the COVID vaccine. Thirteen days after the vaccine I began to experience symptoms like when I had COVID. On day 13 I started to itch and my BP dropped and I became light headed. My vision started to go and I had a hard time breathing and forming words for my husband to help me with some water. This lasted about 20 min. Since then I have been having heart rate increases up into the 150s with minimal effort. Bending like doing dishes or putting away groceries makes me extremely light headed. I have become so tired just folding a little bit of laundry. It wasn?t until a few weeks in that I noticed this was all exactly like when I had COVID. Including being okay in the morning but having so many issues by the evening. So weird. I?m 3 weeks and 4 days past my second shot and finally starting to have some better days again but no day has been symptom free. I wish could know if this is happening to other long haulers and that it will most likely resolve, I have been starting to wonder about disability and really having a hard time facing the fact that I no longer can complete simple house hold chores like I used to.
36 2021-05-21 mouth numbness, mouth tingling Patient received her first dose Pfizer vaccine (LOT#: EW0185 EXP: 8/2021) at 0925 on 5/19/21. Patien... Read more
Patient received her first dose Pfizer vaccine (LOT#: EW0185 EXP: 8/2021) at 0925 on 5/19/21. Patient alerted EMT at 0940. Patient stated that she felt a strange sensation in her mouth/ throat region. Patient then stated that her tongue was numb and tingly. Patient also stated that she felt hot in body temperature. EMT took patients vital signs at 0940. BP: 108/78, pulse: 69, O2: 99%. Patient received water. Patient was offered diphenhydramine at 0946. Patient refused diphenhydramine at 0946. EMT retook vital signs and reassessed patient at 0950. BP: 98/68, pulse: 69, O2: 99%. Patient stated that she felt slightly better. EMT retook vital signs and reassessed patient at 0957 BP: 110/78, pulse: 67, O2: 98%. Patient stated that she felt no symptoms. EMT retook vital signs and reassessed patient at 1010. BP: 108/70, pulse: 62, 02: 98%. Patient stated she felt no symptoms and felt good to leave vaccination site. Patient stated that she had not eaten breakfast. PHN educated patient on worsening signs and symptoms and when to call EMS or go to emergency room/urgent care. Patient verbalized understanding of education. Patient completed observation time. Patient left vaccination site unassisted and with a steady gait at 1015.
36 2021-05-22 feeling of choking Member complained of tingling, tickling sensation on her throat, denies difficulty breathing, itchin... Read more
Member complained of tingling, tickling sensation on her throat, denies difficulty breathing, itching nor swelling. Reported that this happened after the first dose as well. No shortness of breath, nor skin coloring change noted. Appears anxious. Able to swallow normally, tolerating water well. Physician onsite ordered Zyrtec. Cetirizine 10mg sublingual administered. Blood pressure elevated at 196/87, other vital signs stable. Patient reports forgetting to take labetalol today. Complained of headache 2/10. Throat symptoms resolved per patient. Headache improved 1/10. Patient observed for over 1 hour, BP rechecked often, did not decrease significantly. Transferred to ED for high BP.
36 2021-05-22 ringing in ears Tingling in feet and legs, muscle spasms, severe headache, neck and shoulder tension, heart palpitat... Read more
Tingling in feet and legs, muscle spasms, severe headache, neck and shoulder tension, heart palpitations, fainting and now tinnitus
36 2021-05-24 ear swelling, toothache, ringing in ears, pain in jaw, ear pain ringing in ears, pain in left inner ear and left jaw. Swelling in both ears confirmed at urgent care... Read more
ringing in ears, pain in left inner ear and left jaw. Swelling in both ears confirmed at urgent care and began course of decongestants, Allegra, flonase. Pain and inflammation progressed in left jaw and localized to molar tooth (#18). Upon dental visit, it was determined there was extreme inflammation surrounding tooth #18 and underwent emergency root canal on 5/21/21. Persistent inflammation post-root canal with 3200mg Ibuprofen daily, pain and swelling in left lymph node under chin.
36 2021-05-25 dry eye, eye irritation, eye swelling Swollen eyes; Both eyes are dry and feel burning; Both eyes are dry and feel burning; Hives on both ... Read more
Swollen eyes; Both eyes are dry and feel burning; Both eyes are dry and feel burning; Hives on both eyes; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6206) via an unspecified route of administration in the left arm on 15Mar2021 at 09:00 (at the age of 36-years-old) as a single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Allergies to medications, food, or other products reported to Shrimp/seafood (mild). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 19:00, patient experienced hives on both eye. The patient also experienced swollen eyes on16Mar2021 at 08:00 which was followed by dry eyes and burning of the eyes. Therapeutic measures were taken as a result of adverse event and included self-treatment with Benadryl and Allegra. The clinical outcome of the events were reported as recovered with sequelae. No follow-up attempts are needed. No further information is expected.
36 2021-05-25 ringing in ears 30 minutes after second dose, tinnitus started. Tinnitus has continued 24/7 since that moment, it ha... Read more
30 minutes after second dose, tinnitus started. Tinnitus has continued 24/7 since that moment, it has been 2 months so far. Tinnitus pitches and tones vary across 3 types but remains constant.
36 2021-05-25 vision blurred, blindness Within 10 minutes after the vaccine I started to feel very faint and eyes became very blurry and cou... Read more
Within 10 minutes after the vaccine I started to feel very faint and eyes became very blurry and couldn?t see. The pharmacy gave me water and kept making me drink water and kept checking on me. The vaccine spiked my blood sugar. After a little while my sugar went down and I was fine. That evening I had the worst migraine ever and it lasted 3 days. I also had body aches and chills for 3 days as well and fatigue.
36 2021-05-26 eye pain right eye pain for the last 3 days / viralconjunctivitis symptoms; This is a spontaneous report rece... Read more
right eye pain for the last 3 days / viralconjunctivitis symptoms; This is a spontaneous report received from a contactable healthcare professional (pharmacist). A 36-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en9581) via unspecified route of administration in left arm on 06Mar2021 (at the age of 36-years) as a single dose for COVID-19 Immunisation. Past medication included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en5318) via intramuscular route of administration in left arm as a single dose on 18Feb2021 for COVID 19 immunisation. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not have any medical history. The patient was allergic to codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. On 13Mar2021, the patient experienced right eye pain which was one of viral conjunctivitis (not diagnosed) symptoms. The patient had right eye pain for the last 3 days. The adverse event resulted in doctor or other healthcare professional office/clinic. The patient did not receive any treatment for the event. At the time of this report, the patient was not recovered from the event right eye pain. No follow-up attempts are needed. No further information is expected.
36 2021-05-27 mouth numbness 30 minutes after my first vaccine shot I started feeling numbness in my lower lip. It started to cre... Read more
30 minutes after my first vaccine shot I started feeling numbness in my lower lip. It started to creep up the side of my face - the same side as my shot. Within an hour the whole side of my face was numb, I had a pounding headache, and was really dizzy, light headed, and nauseous. After a few phone calls to the clinic, my doctor, and urgent care, I went into the ER. At the ER they first made sure it wasn't a stroke, that was their main concern. It wasn't. They ended up diagnosing me with a migraine (I have never had a migraine in my life). Through an IV they gave me Diphenhydramine, ketorolac, and prochlorperazine. I went home several hours later still feeling awful. But since that day I have been plagued with daily headaches and sporadic facial numbness. I am having a hard time finding a doctor who will see me because they don't know anything about reactions to the vaccine.
36 2021-05-27 toothache, vision blurred Onset of sxs 4 days post 2nd Pfizer COVID vaccine while standing in the kitchen looking for paperwor... Read more
Onset of sxs 4 days post 2nd Pfizer COVID vaccine while standing in the kitchen looking for paperwork Noticed she felt shaky, heart pain with burning, pulse was "going crazy" and going up, hard to focus HR 173 (pulse 160 when the paramedics arrived) Called 9-1-1 Deep burning in her heart Felt like my body was going to explode Whole body painful Vision blurry Pain in teeth Hands were purple and cold - hx of Raynaud's but never had these sxs
36 2021-05-28 mouth discomfort CC: burning in mouth( at 4:05pm) Treatment: no medication was given. patient was under observation. ... Read more
CC: burning in mouth( at 4:05pm) Treatment: no medication was given. patient was under observation. Water improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.
36 2021-05-29 visual impairment Patient received the 1st COVID vaccine (Pfizer, lot # EW0185 use by 06/24/21 at 0845) at 1446. At 15... Read more
Patient received the 1st COVID vaccine (Pfizer, lot # EW0185 use by 06/24/21 at 0845) at 1446. At 1503, the clients boyfriend told PM that his girlfriend said she felt like she was about to faint. PM ran to patient at 1503 who was sitting upright and blankly staring in front of her. RN assessed the client who was alert and oriented to person and place for 90 seconds, but would go in and out of responding to questions during the 90 seconds. No loss of muscle tone was present. The client was unable to visually track an object during the 90 seconds of blank staring. RN instructed another RN to call 911 at 1504. Client was placed on a yoga mat in a supine position on the ground by EMT and PM. The client's legs were elevated by being placed on a chair. The client was diaphoretic and clammy. The client was alert and oriented x 4 at 1505. Radial pulse was bounding bilaterally. Vital signs taken at 1506, HR- 60, BP- 158/106, RR-12, oxygen saturation at 98%. The patient denied any drug allergies, any chronic medical conditions, or currently taking any medications. Client continued to be diaphoretic and clammy. Client did not hit her head during the incident and denied any shortness of breath, chest pain, or difficulty breathing. Vital signs taken at 1507, BP- 170/122, HR- 81, RR-14, oxygen saturation at 98%. The clients legs were immediately placed from being in an elevated position to a supine position. The client was speaking in full sentences and was alert and oriented x4. Vital signs taken at 1508, BP- 146/98, HR-86, RR-14, oxygen saturation at 98%. Client remained mildly diaphoretic and clammy. The fire department assumed care at 1510 when they arrived on site. Fire Department Personnel advised the client to be transported to a hospital, client declined transport to the hospital and signed AMA paperwork. Client stated, "My boyfriend will drive me to Emergency Room." The Fire Department and EMS left the site at 1532. RN educated the client about the importance of going to the emergency room immediately and to follow-up with her primary care provider. The client left the site at 1536, the client's boyfriend pulled the vehicle in the parking area and the client ambulated with an even and steady gait to the car.
36 2021-05-30 swelling of eyelid She received her second dose of the Pfizer Covid vaccine on 5/27 and had expected fatigue/chills/mya... Read more
She received her second dose of the Pfizer Covid vaccine on 5/27 and had expected fatigue/chills/myalgias for the first 2 days. On Sunday evening she developed a full-body rash which started on her back and torso. The rash was itchy, small, red, raised lesions which coalesced into multiple patches on her bilateral upper and lower extremities. The rash is worst now on her lower extremities. She took one half of a tablet of Benadryl at 11:00. She began to develop left-sided angioedema of her lips and bilateral eyelid swelling. She took a full tablet of Benadryl at 1600 and called to the nursing line for her PCP and was advised to present to the ED. She did not have any trouble breathing. She has no voice changes. She did feel lightheaded this morning. She has not felt nauseous or had vomiting or diarrhea. She has had no new exposures, no new detergents/soaps/clothing, has not spent extra time outside. She has no known allergies but notes sensitive skin and some food sensitivities. Upon arrival to the ED, she is afebrile with elevated heart rate and blood pressure, with normal oxygen saturation and no respiratory distress on room air. On exam, she has bilateral eyelid swelling, mild left lip angioedema, and diffuse maculopapular rash. Differential diagnosis includes anaphylaxis, vaccine reaction, allergic reaction to unknown allergen, viral process. She shows no signs of severe anaphylaxis, shock, or respiratory compromise. She was given cetirizine and famotidine for histamine blockade. Based on the lack of other systemic symptoms, steroids were not indicated.
36 2021-05-30 ringing in ears, ear discomfort The day of the shot 5/28/21 I was nauseous and lightheaded, with injection site pain and felt warm b... Read more
The day of the shot 5/28/21 I was nauseous and lightheaded, with injection site pain and felt warm but only had a mild fever for a short time in the evening. When I woke up on 5/29/21 my left ear felt slightly clogged and I had ringing in my ears. I felt fatigued and generally unwell for the whole day. And the injection site was warm to the touch and very painful. Upon waking up on 5/30/21 my overall symptoms improved a lot, arm was still sore but only to the touch, however tinnitus persisted. As of 5/31/21 all symptoms have resolved except the off and on feeling of fulless in the left ear (feels as though it needs to pop and usually does when opening jaw to do so) and the bilateral tinnitus.
36 2021-05-31 vision blurred blurred vision, headache,
36 2021-06-01 ear discomfort, ear congestion, ringing in ears It started as fluttering behind my left ear. It progressed to fullness, ringing, burning sensations,... Read more
It started as fluttering behind my left ear. It progressed to fullness, ringing, burning sensations, headaches, pressure in my head and then moved to the right ear. I have seen one general practitioner, two ENTs and an acupuncturist. I have mostly been dismissed and told there is nothing they can do. The last ENT suggested Flonase. I am still suffering 9 weeks post vaccine.
36 2021-06-01 hearing loss Initial: nausea, dizziness, throat swelling, palpitation. Seen in ED, hypotensive, received epinephr... Read more
Initial: nausea, dizziness, throat swelling, palpitation. Seen in ED, hypotensive, received epinephrine, methlprdnisolone, and fluids with resolution of muffled hearing and throat tightness. Then complained of numbness of tongue, burning of dorsum of tongue, dizziness, dysphagia for approx 3 weeks, then with resolution.
36 2021-06-01 mouth tingling 85kg 5'4" 36yo WF with PMH asthma, anxiety, celiac dx, heart palpitations, lumbar disc dx, migraine ... Read more
85kg 5'4" 36yo WF with PMH asthma, anxiety, celiac dx, heart palpitations, lumbar disc dx, migraine sciatica, allergy to shellfish and fish and multiple drug allergies presented to get her second dose of Pfizer Covid-19 vaccine on 5/25. First dose had been given 5/2/21 (lot # #EW0179) in left deltoid. After 1st shot, patient had neck and arm pain and diarrhea the first 12 hrs. Sought medical attention at urgent care on 5/7 for back ache, low grade fever, sore throat, foggy headed feeling, mild intermittent nausea and diarrhea. Symptoms attributed to Covid19 vaccination. Second Covid19 vaccine (same lot) given in left deltoid at 1536 5/25. 5 minutes after receiving the vaccine, patient complained of tongue tingling, feeling flushed, sharp chest pain, burning on face, itching and SOB. Patient had rash on check and neck. Hives appeared. Patient wheezing. Patient reported reaction was similar to reaction to fish. Patient's own epinephrine pen was expired. Pt assisted to recline and legs elevated. VSS. BP 130/80s, HR 100's RR 20; O2 99% on RA. EMS was called. 0.3mg IM epinephrine given ~1550 while waiting. EMS treated with 50mg diphenhydramine, 20mg famotidine and ondansetron 4mg IV at 1610. Symptoms improved but returned so another 0.3mg epinephrine IM was given at 1620. Transferred to ED where patient c/o nausea, tingling of chest/lips and throat stinging. Epinephrine 0.5mg IM charted as given. Tachycardic from epinephrine administrations. Treated with dexamethasone 4mg po at 1941 as patient reported reacting to methylprednisolone. Patient discharged 5/25 PM. Patient reported recurrence of flushing, mouth tingling and nausea but refused to seek treatment at UC or ED. Advised to take Claritin or Zyrtec. Patient saw physician covering her PCP on 5/28/21. On that day, patient reported she was having waves of feeling flushed or hot over the last few days and her tongue is still slightly tingly but she denies swelling of lips or throat, chest pain, palpitations. Covid-19 vaccine allergy was added to this patient's allergy list.
36 2021-06-02 ringing in ears My ear started ringing really badly and the outside went numb on the outer structure and about 1-2 i... Read more
My ear started ringing really badly and the outside went numb on the outer structure and about 1-2 inches around that. It lasted for about an hour and then went back to normal. I haven't experienced it since.
36 2021-06-05 oropharyngeal discomfort, eye strain, eye discomfort, sensitivity to light Immediate dizziness. Rapid heart beat. Warmth. Sensitivity to light. Discomfort in throat and upper ... Read more
Immediate dizziness. Rapid heart beat. Warmth. Sensitivity to light. Discomfort in throat and upper abdomen. Chest tightness. Heaviness in head and eyes. Monitored for 2 hours in clinic. Fatigue, intermittent chest pain and persistent discomfort in head, eyes and abdomin are ongoing now, over 48 hours later.
36 2021-06-06 ringing in ears Tinnitus developing around nine days after shot. Symptoms remained for a few days and then (mostly) ... Read more
Tinnitus developing around nine days after shot. Symptoms remained for a few days and then (mostly) subsided. This happened after the first Pfizer dose (as reported here) and also after the second Pfizer dose 3 weeks later.
36 2021-06-07 blindness, eye irritation now inflammation that is causing blindness; eye irritation; inflammation; Open-Angle Glaucoma; Uveit... Read more
now inflammation that is causing blindness; eye irritation; inflammation; Open-Angle Glaucoma; Uveitis; Granulomatous Anterior Uveitis; Uveitic Ocular Hypertension; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: er8735; Expiration Date: 31Jul2021), 1st dose via an unspecified route of administration, administered in Arm Left on 01May2021 at age of 36 years old as a single dose for COVID-19 immunisation. Medical history included celiac disease and gastroparesis. The patient's concomitant medications were not reported. The patient experienced open-angle glaucoma, uveitis, granulomatous anterior uveitis, uveitic ocular hypertension, all on 16May2021, now inflammation that is causing blindness, eye irritation, inflammation, all on an unspecified date. The patient underwent lab tests and procedures which included weight: 73.48 kg, height: 145cm, both on an unknown date. Therapeutic measures were taken as a result of all events. The outcome of the events was not recovered. Clinical course: consumer stated, "I was calling to report a possible side effect I do not see to do it online so I decided to call in." Consumer stated, "I had started to having a eye irritation that has turned into glaucoma that they are thinking had a now inflammation that is causing blindness." Consumer informed about Pfizer medical information department. Consumer stated, "Expiration July 31, 2021." Consumer stated, "Its started on Sunday ( Later confirmed May 16 2021)." Site of vaccination: consumer stated," Left arm." Other medication for medical conditions: consumer stated, "No , nothing Its all diet , its diet regulation." Lab Test: consumer stated, "No, everything comes negative." Still experiencing the events: consumer stated, "Yes, its same." Outcome of events: consumer stated," Same." Treatment in response to events: Consumer stated, Valacyclovir, Cyclopentolate, Brimonidine, Acetazolamide, Prednisolone." There had no known allergies. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. The adverse events (open-angle glaucoma, uveitis, granulomatous anterior uveitis, uveitic ocular hypertension) resulted in following: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The treatment for the adverse events was included medications and eye drops. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
36 2021-06-08 taste impairment really bad metallic taste in her mouth; This is a spontaneous report from a contactable consumer (pa... Read more
really bad metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in the left arm on 09Mar2021, 13:15 (at the age of 36 years old), as first dose, single dose for COVID-19 immunisation. Medical history included bipolar disorder, anxiety disorder, and hepatic adenomatosis. The patient was not pregnant on the time of the report. Concomitant medications included lithium, quetiapine fumarate (SEROQUEL), dicyclomine, fexofenadine hydrochloride (ALLEGRA), alprazolam (XANAX). The patient did not receive other vaccines within four weeks prior to vaccination. The patient had a really bad metallic taste in her mouth starting approximately one hour after vaccination and lasted for 10 hours on 09Mar2021, 14:15. The patient had no COVID prior vaccination and was not COVID tested post-vaccination. No treatment was received for the event. The outcome of the event was recovered on 10Mar2021, 00:15. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
36 2021-06-09 mouth tingling Upper lip tingling immediate after the injection Left and right calf pain Left calf muscle pain pers... Read more
Upper lip tingling immediate after the injection Left and right calf pain Left calf muscle pain persistent Muscle pain throughout the body Dizziness and lightheaded Pain at the injection site
36 2021-06-10 swelling around the eyes, pain in jaw, swelling of eyelid, toothache Pocket of swelling under left arm, fever over 101 (started at 1am Sunday morning), allergy effects (... Read more
Pocket of swelling under left arm, fever over 101 (started at 1am Sunday morning), allergy effects (runny nose, sneezing, coughing-all day Sunday), swelling of the cheeks, swelling of both eye lids and surrounding area (left eye worse), stabbing pain all over face in waves, starting at sinus area, going down to the teeth, back up to the jaw and ears and down the throat, and hit and cold sweats (all the last symptoms were from 8pm Sunday night to 5am Monday morning).
36 2021-06-12 loss of taste, tongue disorder, taste disorder, mouth tingling A wide range of food has been tasting bland to me, and sometimes has no taste at all. These are food... Read more
A wide range of food has been tasting bland to me, and sometimes has no taste at all. These are foods I typically enjoy very much. At first I thought I must have burnt my tongue, which was negatively impacting my sense of taste, but the sensation did not go away. My tongue tingles on both sides and on the top, near the front. The tingling sensation happens whether I am eating or not. The tingling at the top of my tongue is amplified when I press my tongue to the roof of my mouth, or put pressure on my tongue with food (such as when eating an ice cream cone, for instance). There are also bumps in the back of my tongue, on both sides, though they seem to have no feeling and I'm not sure if they are normal or not (I don't usually inspect my tongue to that degree) . I don't have the exact date this began, as it wasn't initially so disconcerting, though it was around the end of April or beginning of May 2021. It has been going on for at least a month, so clearly is not the result of my tongue being burnt when drinking a hot tea. I am very concerned that I may be losing my sense of taste, which definitely dampens (and in some cases completely removes) my enjoyment of food.
36 2021-06-13 dry throat Systemic: throat dryness-Mild, Additional Details: took benadryl and throat dryness resolved
36 2021-06-13 vision blurred C/O NUMBNESS ON LEFT SIDE OF BODY, FOGGY FEELING, CHILLS, FATIGUE, ITCHY THROAT, BURNING GUMS, BLURR... Read more
C/O NUMBNESS ON LEFT SIDE OF BODY, FOGGY FEELING, CHILLS, FATIGUE, ITCHY THROAT, BURNING GUMS, BLURRED VISION, "FEELS LIKE SHE HAD A CONCUSSION" SAW AT ER AND GIVEN BENADRYL AND ADVISED THIS WAS A REACTION TO THE VACCINE
36 2021-06-14 vision blurred Vision changes: blurred vision Dizziness throughout the day Swelling and stiffness of knuckles Pass... Read more
Vision changes: blurred vision Dizziness throughout the day Swelling and stiffness of knuckles Passing blood clots similar to menstruation.
36 2021-06-15 ear discomfort Fatigue,headache,gluten intolerance(migraine headache after eating bread),dizziness at least every o... Read more
Fatigue,headache,gluten intolerance(migraine headache after eating bread),dizziness at least every other day.feeling of pressure buildup in neck,and ears when bending over or laying down.Shortness of breath. Difficulty remembering things and slurring of words.Difficulty verbally constructing sentences.
36 2021-06-15 ringing in ears Heart Palpitation Fatigue Dizziness Buzzing in Ear
36 2021-06-16 taste impairment metallic taste; This is a spontaneous report from a contactable consumer (patient). A 36-years-old f... Read more
metallic taste; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown and expiration date not reported) via an unspecified route of administration on an unspecified date (at the age of 36-years-old) as unknown single dose for COVID-19 immunization. The patient medical history included COVID-19 from an unknown date and unknown if ongoing. The patient had no allergies to medications, food, or other products. The patient concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. On May2021, the patient experienced metallic taste. The patient underwent lab tests and procedures which included: post the vaccination on May2021, the patient had sars-cov-2 test and result was unknown. The patient did not receive treatment for the event. The event was considered as non-serious by the reporter. The outcome of event was not resolved. Information regarding the lot/batch number has been requested.
36 2021-06-16 eye pain, visual impairment decreased vision and pain with extraocular eye movements on left eye with associated afferent pupill... Read more
decreased vision and pain with extraocular eye movements on left eye with associated afferent pupillary defect, decreased color vision, optic nerve edema
36 2021-06-17 ear discomfort Exactly 2 weeks after receiving the vaccine, I started feeling extremely dizzy 24/7. Since then, I h... Read more
Exactly 2 weeks after receiving the vaccine, I started feeling extremely dizzy 24/7. Since then, I have had no relief in this symptom. Any time I eat anything at all, I feel intense pressure in my sinuses area, my head, behind my ears, and become very dizzy. I often stumble due to the dizziness and have to close my eyes most of the day. It has been very debilitating. I am unable to work, and everyday tasks are very challenging.
36 2021-06-21 lip dry, dry mouth, thirst Within an hour of vaccine receipt, patient noted increased thirst with dry mouth and lips. She incre... Read more
Within an hour of vaccine receipt, patient noted increased thirst with dry mouth and lips. She increased her water intake over the next 48 hours. Around 4 Apr, she noted cracking at the corners of her mouth. During that time, she applied lip balm and Chapstick to her lips almost constantly, with Neosporin applied to the areas cracking. The following week (week of 5 Apr), she noted her labia were itchy and irritated; she denies vaginal irritation or discharge. No abdominal or pelvic pain. She applied an antifungal cream to the area with some relief of symptoms. Also that week (week of 5 Apr), patient had itching and dry, flaking skin in her external ears; no discharge or pain from inner ear. She also noted that her taste buds were enlarged and red; they were irritated and they burned if she ate spicy food. The following week (week of 12 Apr), patient noted her scalp was itching and flaking, so she started using Selsun shampoo. Then, her hands became very dry and itchy, and began to peel. Her feet developed small, itchy vesicles that dried and then peeled. Patient attempted to be evaluated, but the first available face-to-face appointment was not until 3 May. At that time, exam of her skin noted: macule seen on Palms of b/l hands- macular scaly lesions that are peeling. b/l feet (near arch, lateral surface) small macular lesions w/o ulceration, nonvesicular nor pustular. R corner of mouth- with small crack, no erythema or discharge. - Scales were seen. Assessment/Plan: 1. Dermatitis, unspecified: Suspect flare of Atopic dermatitis. 2. Other specified disorders of the skin and subcutaneous tissue: Suspect angular chelitis of R corner of mouth She was prescribed Fluocinonide 0.05% and Ceramide creams to apply to her hands and feet. Mupirocin 2% ointment ((apply to lips) and Clotrimazole 1% vaginal cream were also prescribed. Patient denies onset of facial swelling, swelling and itching of mouth and throat, difficulty swallowing or breathing, wheezing, watery eyes, cough, increased heart rate, lightheadedness, and GI-symptoms within the first 12 hours post-vaccine receipt. Patient was feeling well on the day of vaccine receipt and denies any other possible exposures, including changes in foods and medications, and personal care products. She denies bug/insect bites, chemical exposure, exposure to plants, and exposures to sick contacts. She reports a negative health history for chronic or long-standing health conditions, except for a history of Atopic Dermatitis, with her last flare about 10 years ago. Patient also reports receipt of lip fillers 4 to 5 years ago. She denies a history of COVID infection; she has tested negative 3 times for SARS-CoV-2. Recently, patient reports increased stressors and just initiated Bupropion. Otherwise, she takes no routine medications. She has a Mirena IUD. She has no known allergies to medication, food, latex, or insect stings. Patient denies previous history of reactions following vaccine receipt. She has no history of similar rashes or dermatitis, except peeling of skin on hands and feet are similar to flares of atopic dermatitis). Patient works as a dental hygienist. On 18 May, patient had noted near resolution of all oral-facial symptoms. Her other cutaneous symptoms had improved significantly, but she was still reporting pruritus of the scalp, feet, and hands. She had just initiated a Medrol Dosepak, Atarax, and Ketoconazole shampoo.
36 2021-06-23 vision blurred, hearing loss Approx. 1 min. after vaccinated pt co muffled hearing, blurred vision, swearing and in & out of cons... Read more
Approx. 1 min. after vaccinated pt co muffled hearing, blurred vision, swearing and in & out of conscious. Patient did not recall moving from chair to elevate feet. Vital signs at time of incident BP 98/52, Pulse 46, oxygen 97%. Patient waited for 30 minutes after episode and was evaluated by EMS.
36 2021-06-24 taste impairment Sore arm; Piercing headaches; Everything was too heavy for left arm; as soon as she got the shot, wi... Read more
Sore arm; Piercing headaches; Everything was too heavy for left arm; as soon as she got the shot, within seconds she got the feeling when she eats something sour; Tingling feeling in the back of her jaw on the left hand side/Palm of hand tingling to tips of fingers/Her arm started tingling within 15; Entire left arm went numb/her arm was numb up to the elbow; This is a spontaneous report from contactable consumer reporting for herself. A 36-years-old pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH- mRNA COVID-19 VACCINE; Solution for injection; Lot Number ER8735; Expiration date was not reported), via an unspecified route of administration, administered in left arm on 30Apr2021 11:30 (At the age of 36-years-old) as single dose for COVID-19 immunisation (to not die from Covid). Medical history included none. She is only on birth control. She has no medical conditions that she knows of. Family medical history: the only major thing was diabetes. Patient concomitant medications included, ongoing Birth control since she was 20, so 16 years from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the vaccine and had no adverse reactions that she knew of. The only thing she was ever told was, she was allergic to Penicillin. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Patients Medical History was, none.It was reported that, as soon as the patient got the shot, within seconds she got the feeling when she eats something sour, patient had a tingling feeling in the back of her jaw on the left-hand side (the side she got the shot). As she was waiting her entire left arm went numb and the palm of her hand was tingling to the tips of her fingers on 30Apr2021. On 01May2021, patient experienced sore arm, piercing headaches and everything was too heavy for left arm. Patient was just calling to check and wanted to report her symptoms. Patient asked if it was okay to get the second dose of the Covid Vaccine. She did not have the Physician details information handy and stated that never seen her because of Covid. Her jaw started tingling within seconds. Throughout the day it would come and go. It was just on the left-hand side. She probably experienced it twice, maybe 3 times that day. Her arm went numb as she was sitting for 15 minutes and waiting. It was not right away like the sour thing. When she got up, they said she could go which is another story. Her arm was numb, and she had tingling in the palm of her hand throughout her fingers. By the end of the night her arm was numb up to the elbow. She did notice on Saturday when she got a sore arm that holding her phone on the left side and everything was too heavy. It was like her arm was extra relaxed. She could not hold her phone in her hand for too long. It was extra relaxed, and even driving she could not hold on for long. She did not notice it much the day before, but she for sure had it for the whole day on Saturday. Patient also had piercing headaches that comes and goes. Her palm started tingling within 15 minutes. They kept her there for like an hour. Patient still had it halfway through the day. Her arm was sore on Saturday morning, which actually went away by Sunday. Patient thought she was recovered completely. She had not noticed anything that would make her think it had not. Her headaches started probably Saturday night. They were off and on, the day before the time of this report. Patient had one the morning on the day of reporting this event when she was on the phone. They come for a second then just go away. Patient did not require visit to Emergency room or Physician office due to the events. Investigation assessment or relevant tests included none. Investigation Assessment: No. Clinical outcome of the events tingling feeling in the back of her jaw on the left-hand side, arm started tingling, palm of hand tingling to tips of fingers recovered on 30Apr2021; outcome of the event sore arm recovered on 02May2021, piercing headaches had not recovered and outcome of other events were unknown. No follow-up attempts are needed. No further information is expected.
36 2021-06-24 eye itchiness, bloodshot eyes, lacrimation increased eyes red; itchy eyes; watery eyes; This is a spontaneous report from a contactable consumer. A 36 ye... Read more
eyes red; itchy eyes; watery eyes; This is a spontaneous report from a contactable consumer. A 36 year old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via unspecified route of administration in the left arm on 14Mar2021 at 13:30 (at the age of 36 years) as a single first dose for Covid-19 immunisation. The patient's concomitant medications included zzzquil (MANUFACTURER UNKNOWN), junel (MANUFACTURER UNKNOWN), restasis (MANUFACTURER UNKNOWN) and fluoxetine (MANUFACTURER UNKNOWN). Allergies to medications, food, or other products was reported as gluten, liquid tylenol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Mar2021 at 06:30AM, the patient experienced events eyes were red and itchy when she woke up the next morning. They were then red, itchy, and watery. The clinical outcome for events red eyes, itchy eyes and watery eyes were not recovered at the time of reporting. The patient underwent nasal swab, PCR test for COVID 19 virus on 18Mar2021, post vaccination and tested negative for the same. The patient received treatment for red, itchy and watery eyes as prednisone (MANUFACTURER UNKNOWN), Benadryl (MANUFACTURER UNKNOWN), CLARITIN, zatidar (MANUFACTURER UNKNOWN) and the adverse events resulted in doctor or other healthcare professional office/clinic visit. Information about lot/batch number cannot be obtained. No further information is expected.
36 2021-06-28 loss of taste Started with high fever. Too sick to take temperature. Fever lasted about 48 hours. Chills and aches... Read more
Started with high fever. Too sick to take temperature. Fever lasted about 48 hours. Chills and aches. Nausea and vomiting lasting about 24-48 hours. Every joint and bone hurt me as if they were trying to pull apart. This lasted for days. My hips and lower back took the longest to stop hurting. It wasn?t until about the fifth day that I wasn?t in excruciating pain. Loss of taste for about 72 hours. No appetite for about 3 days. Everything looked yellow, like there was a yellow filter on everything. That lasted about 4-5 days with the tint being less each day.
36 2021-06-28 eye twitching Severe non-stop heart palpitations for 3-4 weeks, extreme fatigue, shortness of breath, complete los... Read more
Severe non-stop heart palpitations for 3-4 weeks, extreme fatigue, shortness of breath, complete loss of appetite, weight loss over 10 lbs. Severe abdominal pain on Apr 23rd. Neurological symptoms such as eye twitching. Burning sensation in throat and gut. Three ER visits between April 20 and May 4th. Extreme fatigue and and have had to take off from work and studies for over 2 months. Following up with neurologist for diagnosis. I have taken a second shot on June 14th, J&J vaccine.
36 2021-06-28 ear infection Temperature 1 week of ear infection type symptoms 2 days unable to sit and walk
36 2021-06-29 ear swelling, ear pain Earache; swollen ear; spot bleeding; This is a spontaneous report from a contactable physician, the ... Read more
Earache; swollen ear; spot bleeding; This is a spontaneous report from a contactable physician, the patient. A 36 -years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021at 08:00 (at the age of 36-years -old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and concomitant medication. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9269) via an unspecified route of administration in the left arm on 27Feb2021at 09:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient had not tested for COVID-19. The patient not had any symptoms associated with COVID-19. The patient did not have allergies to medications, food, or other product. On 20Mar2021 at 20:00 the patient experienced earache, swollen ear and spot bleeding. The patient received Tylenol and diphenhydramine for the treatment of events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of earache, swollen ear, spot bleeding was recovering. No follow-up attempts are needed. No further information is expected.
36 2021-06-29 eye itchiness, lacrimation increased Nausea, headache, moderate arm pain, mild chest tightness, chest fluttering, increased heart rate, s... Read more
Nausea, headache, moderate arm pain, mild chest tightness, chest fluttering, increased heart rate, short of breath (mild), fatigue, itchy watery eyes, hiccups, indigestion.
36 2021-06-30 pain in jaw, taste impairment Symptoms following 1st dose (5/28/2021 08:55): Metallic taste within 15 minutes from injection. Nec... Read more
Symptoms following 1st dose (5/28/2021 08:55): Metallic taste within 15 minutes from injection. Neck stiffness and moderate jaw pain started within 30 minutes. The following day, had arm soreness which was relieved by use. Headache for next few days. Four days from injection, started four days of feeling ill with fatigue, sore lymph nodes throughout body, trouble concentrating, achiness, and dull pain in center of chest. Chest pain lasted about 2 weeks. Lymph node soreness lessened until only one (behind left ear) was still sore at the time of the 2nd dose. Symptoms following 2nd dose (6/18/2021 09:00): Bitter taste within 15 minutes from injection. Minor jaw pain the same day. In the middle of the night, woke up violently shivering although room was warm. Mild tenderness at injection site and mild headache for a few days. Three and a half days from injection, developed sore throat, runny nose, and fatigue which lasted for about 5 days. One week from vaccination, went to urgent care clinic to get COVID-19 PCR test (negative) to rule out symptoms being caused by Delta variant. As of today (7/1/2021), continue to have occasional mild soreness in lymph node behind left ear.
36 2021-06-30 vision blurred Beginning a few days after my second vaccination and continuing to the present day I have had increa... Read more
Beginning a few days after my second vaccination and continuing to the present day I have had increased dizziness. It may stem from inner-ear instability. During the dizzy spells it is difficult to visually focus on things near to me. There have been 2 events in which I was driving and pulled over as a result. I am a fit and healthy person that regularly exercises 7+ times per week and did not have dizziness issues prior.
36 2021-07-01 visual impairment Woke up early day after receiving vaccine with a tingling sensation all over my body and feeling gro... Read more
Woke up early day after receiving vaccine with a tingling sensation all over my body and feeling groggy. I thought my walk to work would help, but part way there I became so weak I could barely make it. When I got to work I was confused and couldn't figure out what to do. I became diaphoretic and shaky (not rigoring). Admin staff called employee health who advised she call 911. I declined and another staff member provided Benadryl and Advil which I took around 0830. Went to urgent care: labs drawn, ECG performed (WNL so troponin and CXR not obtained). Having visual disturbances at urgent care and mild SOB. Received 4mg dexamethasone (I'm very sensitive to meds) and was sent home. Awake all night w/heart palpitations (from dex??) and for the following several weeks experienced intermittent chest pain, SOB, and dizziness. Missed 1 day of work d/t AEs. I am an avid hiker and have experienced wheezing and chest tightening shortly after starting every hike I've been on since receiving the 2nd dose of the COVID vaccine; no prior hx of anything similar.
36 2021-07-02 taste impairment Headache lasting 8 days, ongoing. Experienced a metallic taste for 6 days.
36 2021-07-02 mouth itchiness itchy mouth; burning/extreme heat in abdomen.; This is a spontaneous report from a contactable consu... Read more
itchy mouth; burning/extreme heat in abdomen.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EM9810), via an unspecified route of administration in the right arm as single dose (at the age of 36-years-old) on 11Feb2021 at 08:15. Medical history included asthma. The patient had seasonal allergies, pet dander allergy, dust mites and mold allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other medications (unspecified) within 2 weeks of vaccination. Patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN620), via an unspecified route of administration in the right arm on 04Mar2021 (at the age of 36-years-old); as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, patient had not been tested for COVID-19. On 11Feb2021 at around 08:30, 8 minutes after the first shot, the patient experienced rush of heat concentrating in lower abdomen followed by a brief bout of an itchy mouth. The patient was observed for an hour and BP, heart rate and oxygen levels were monitored. BP, heart rate and oxygen levels readings were fine with no further issue. After leaving the vaccination site, the patient had several feelings of burning/extreme heat in abdomen. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events burning in abdomen and itching mouth were resolved on an unknown date. No follow-up attempts possible. No further information expected.
36 2021-07-02 ringing in ears Tinnitus
36 2021-07-04 loss of smell, loss of taste Client was vaccinated with Pfizer vaccine for Covid on April 10 and May 1, 2021. She developed Covi... Read more
Client was vaccinated with Pfizer vaccine for Covid on April 10 and May 1, 2021. She developed Covid symptoms on July 1, 2021 (nasal congestion, chest congestion, fatigue, mild myalgia, sore throat, mild loss of taste and smell). She tested positive with rapid test on July 4, 2021. This case being reported as client was fully vaccinated against Covid illness and became symptomatic and tested positive over 2 weeks s/p vaccination.
36 2021-07-06 ear discomfort, fluid in middle ear On April 30 I went to see the doctor for pressure on my ears. She saw fluid and prescribed a steroid... Read more
On April 30 I went to see the doctor for pressure on my ears. She saw fluid and prescribed a steroid. It didn?t help. A week later she prescribed an antibiotic. That didn?t work either. I saw an ENT on 6/21/21 and he did not see fluid on my ears and recommended an mri.
36 2021-07-06 mouth discomfort, lip dry, lip itchiness, lip swelling, chapped lips Swelling of lips at night with severely swollen lips in the morning. Chapped dry lips that?s burn an... Read more
Swelling of lips at night with severely swollen lips in the morning. Chapped dry lips that?s burn and itch. This has been on going since about 2 weeks after my shots. Last week we trialed a weeks dose of prednisone and loratadine but once the meds were done the swelling and itching have returned
36 2021-07-08 oropharyngeal discomfort feeling faint; My throat feels a little weird; This is a spontaneous report from a contactable consu... Read more
feeling faint; My throat feels a little weird; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; ER8730) via an unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 10:15, within few minutes of receiving the vaccine the patient felt like fainting. When notified to the staff, the patient was asked to sit in another room and started to feel better in the room. It had been in 45 minutes and then the patient was back home. It was also reported that the patient had a weird feeling in the throat which was hard to describe but he generally felt ok. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No treatment was received for the adverse events. The clinical outcome of the events feeling faint and throat discomfort were recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
36 2021-07-09 visual impairment Second dose of Pfizer vaccine given on 5/4/2021 to left Upper arm. I immediately felt burning inside... Read more
Second dose of Pfizer vaccine given on 5/4/2021 to left Upper arm. I immediately felt burning inside my left shoulder joint as the medication was being pushed in. Approx 20 min after injection as I was waiting/being monitored I felt very dizzy and felt like I was going to pass out, I was seeing stars. Nursing staff had me lay on a stretcher and drink fluids. I have had burning pain inside my left shoulder joint since. It is exacerbated when lifting left arm above my head and across my chest. I have trouble lifting heavy objects and holding doors open. I was seen by orthopedic Dr. 6/7/2021 and he said that if pain persisted into July I should be seen again for a steroid injection to the left shoulder to decrease inflammation and pain secondary to the injection, likely causing subacromial bursitis. I have a follow appointment scheduled 7/19/2021.
36 2021-07-10 mouth tingling Pain and weakness arms and legs muscle spasms legs arms heavy don't move right extreme fatigue heada... Read more
Pain and weakness arms and legs muscle spasms legs arms heavy don't move right extreme fatigue headaches fell tripped a few times in early days occasionally tongue feels weird kinda nb and in the way
36 2021-07-11 swelling around the eyes Left arm went completely numb within minutes of receiving injection. Numbness did not go away for se... Read more
Left arm went completely numb within minutes of receiving injection. Numbness did not go away for several hours, arm remained painfully sore for 3 days afterwards. 2 days after receiving the injection, the area underneath my left eye became painfully swollen and persisted for 4 days. Once the left eye cleared up, the area underneath my right eye became painfully swollen which lasted for 2 days.
36 2021-07-12 double vision, eye movement disorder I was admitted to hospital on May 22, 2021, for a complex combination of neurological symptoms inclu... Read more
I was admitted to hospital on May 22, 2021, for a complex combination of neurological symptoms including double vision, abnormal eye movement called nystagmus, leg weakness, and numbness.
36 2021-07-13 taste impairment, mouth tingling, mouth numbness Within 5 minutes of getting the shot, I got a weird metallic/salty-saline taste in my mouth that las... Read more
Within 5 minutes of getting the shot, I got a weird metallic/salty-saline taste in my mouth that lasted until Saturday/Sunday. Also gradually within an hour, my left side of my mouth (cheek, bottom lip, gums) went completelt numb. That last until Saturday then it became tingly like for the next few days after that. I was able to use facial muscles, I just literally had no feeling. My heart started to have palpitations and I am pretty sure it went into AFib until Friday. I also felt like I had vertigo for the first 24 hours. I could not keep balance like I was very intoxicated. With my endometriosis, it did also cause a d Flare up in my back pelvic area like my endo has returned to my "cal de sac" area. That lasted a few days too.
36 2021-07-13 ringing in ears Pt had first Pfizer covid shot 3/18 with numbness tingling into L arm, then bilateral LE's and short... Read more
Pt had first Pfizer covid shot 3/18 with numbness tingling into L arm, then bilateral LE's and short time in head, all resolved by day 18. Had separate VAERS for that. Was adviced not vaccine-related, recommended second dose. The patient did end up receiving the second dose of Pfizer 4/8/21 and is now about 12-13 weeks out with pretty severe ongoing symptoms; symptoms were "10 times worse" night of vaccine than first experience, and have persisted. Paraesthesias described as ?pins and needles? with occasional ?ice pick jabbing?, tremor both visible and perceived, that seem to be worsening. she had tinnitus, consulted with ENT and did Prednisone for 5 days, with resolution but tremor and tingling worse on that so stopped. She has seen ENT, Allergist, Neurology, family medicine x3. Has upcoming follow-up with Neurology and will be consulting with Functional Medicine. Are you getting other reports of similar neurologic symptoms/side effects? I'm troubled by her experience as an otherwise healthy no med/no medical condition patient now with severe daily symptoms, and wondering what could be the pathophysiology and/or possible treatment options. I do appreciate your attention to this concern, as well as to your ongoing surveillance and diligence in this vaccine roll-out.
36 2021-07-14 loss of taste, loss of smell patient develop new loss of taste or smell, sore throat, nasal congestion on 07/12. She tested posi... Read more
patient develop new loss of taste or smell, sore throat, nasal congestion on 07/12. She tested positive for COVID on 07/14.
36 2021-07-14 eye pain Uveitis on left eye causing extreme pain. Prednisolone Acetate (hourly) and Atropine were prescribed... Read more
Uveitis on left eye causing extreme pain. Prednisolone Acetate (hourly) and Atropine were prescribed. A periocular corticosteroid injection was done less than a week later and medication stopped. Within 48 hours the uveitis flared and I was back to hourly Prednisolone. I was gradually weened off weekly for the subsequent four weeks. Then synechiae formed 360 degrees around the iris, causing iris bombe and pressure topping out at 63. An emergency laser peripheral iridotomy was performed creating a hole in the iris; Diamox 250 and Combigan were prescribed (3/day & 2/day respectively) in conjunction with Prednisolone (4/day). Two days later with the pressure again elevated, we attempted to break the synechiae via dilation (Diamox stopped). This process was repeated two more times in the following two weeks. Within this time frame, pressure escalated to 45 and I was put back on Diamox (4/day) and Latanoprost was prescribed (1/day). Also Tropicamide 1% and Phenylephrine 2.5% were prescribed (3/day each) to attempt to keep eye dilated. With the dilation not working, the hole completely sealed due to inflammation and the bombae yet again returning, another iridotomy was done. This time reopening the original and producing two additional holes. Currently I am off Diamox, Latanoprost, Tropicamide and Phenylephrine - but still on Atopine (3/day), Combigan (2/day) and Prednisolone Acetate (hourly). One day after the second laser, my pressure is currently at 6 with mild inflammation. I have another appointment with both Dr's on 7/19 to see if it will hold without the Diamox.
36 2021-07-15 mouth tingling Patient came into clinic for Pfizer #2, on way in, daughter reported to HCP that "mom was walking li... Read more
Patient came into clinic for Pfizer #2, on way in, daughter reported to HCP that "mom was walking like she was drunk". Patient also stated she become suddenly fatigued driving. patient also reported Intermittent respiratory difficulty and moth tingling. Patient's father also had Guillian Barre patient admitted to Hospital ER
36 2021-07-17 ear discomfort mild flu like symptoms; Mild fever; sore throat; lymph nodes; ears feel clogged; This is a spontaneo... Read more
mild flu like symptoms; Mild fever; sore throat; lymph nodes; ears feel clogged; This is a spontaneous report received from a contactable consumer, the patient. A 36-Year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in her left arm on 26Feb2021 at 09:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis, bipolar and post-traumatic stress disorder (PTSD). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included clonazepam (KLONOPIN), lamotrigine (LAMICTAL), quetiapine fumarate (SEROQUEL) and escitalopram oxalate (LEXAPRO) all for an unknown indication and from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 26Feb2021 at 09;00, the patient experienced mild flu like symptoms every day at the same time each day, felt after the second dose, but was not nearly as symptomatic, mild fever, sore throat, swollen lymph nodes and ears feet clogged. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcomes of the events flu like symptoms, mild fever, sore throat, lymph nodes and ears feel clogged was unknown at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected
36 2021-07-18 loss of smell VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being ... Read more
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 12/22/21,pfizer,Lot#EK9231 2nd dose: 01/11/21,Pfizer,Lot# EL3248 Diagnosed covid positive:07/13/21 Exposure:Community Symptoms: All symptoms.(fever, headache,nausea, loss of smell, body aches, sore throat)
36 2021-07-18 inability to speak Fever 7/3/21 Cough and Mucous - green mucous 7/3/21 to 7/13/21 Sore Throat 7/3/21 - 7:00am Lost voi... Read more
Fever 7/3/21 Cough and Mucous - green mucous 7/3/21 to 7/13/21 Sore Throat 7/3/21 - 7:00am Lost voice 7/3/21 - 8:00pm. 24 hours Hoarse voice - 7/5/21 to 7/13/21. 9 days Dizziness 7/5/21 to Present. Treatment over the counter dizziness medication.
36 2021-07-18 dry eye 1st dose 01/02/21 pfizer,Lot#EL0142 2nd dose: 01/23/21,Pfizer,Lot# EL9262 Diagnosed with Bell's pals... Read more
1st dose 01/02/21 pfizer,Lot#EL0142 2nd dose: 01/23/21,Pfizer,Lot# EL9262 Diagnosed with Bell's palsy on 6/30/21; patient believes this is related to the Pfizer COVID vaccine, which she received on 1/2/21 and 1/23/21, reports she developed right-sided facial droop. She was evaluated at ED, reassured, prescribed oral steroid and anti-viral medication. states her symptoms are improving; she is still experiencing some dryness in her R eye for which she has been prescribed moisturizing eye drops.
36 2021-07-18 ringing in ears Nausea, ringing in ears, fatigue, muscle and joint aches, fever, headache, chills
36 2021-07-19 taste impairment Ran a 102-4 degree fever for approximately 36 hours, followed by a 101 degree fever currently.; I ha... Read more
Ran a 102-4 degree fever for approximately 36 hours, followed by a 101 degree fever currently.; I have large painful lumps in both armpits (golf ball size).; I have large painful lumps in both armpits (golf ball size).; I have had full bodyaches,; joint pain; chills during fevers, especially at night.; I have a very prominent metallic taste in my mouth.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypothyroidism and depression. Concomitant medications included bupropion hydrochloride 160 (WELLBUTRIN), levothyroxine .50 (MANUFACTURER UNKNOWN)) and fluticasone propionate; salmeterol xinafoate 250 (ADVAIR); all taken from an unspecified date for an unknown indication. The patient was allergic to latex, kiwi, avocado, banana, pineapple and mango. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 12:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Mar2021 at 20:00, the patient experienced 102 - 4 degree fever for approximately 36 hours, followed by a 101 degree fever currently. The patient had large painful lumps in both armpits (golf ball size); also had full body aches, joint pain, and chills during fevers, especially at night. The patient had very prominent metallic taste in my mouth. The event did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events fever, swelling, armpit pain, general body pain, joint pain, fever chills and taste metallic were not resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
36 2021-07-20 dry throat Headache x 20 minutes. Left posterior pharynx felt dry and itchy. Generalized itching without hives
36 2021-07-21 mouth tingling Day 14 sharp shooting pain left back; Day 13 weakness with workout/grip; Day 12 decreased sensation;... Read more
Day 14 sharp shooting pain left back; Day 13 weakness with workout/grip; Day 12 decreased sensation; Tingling left shoulder; Day 9-10 finger pain, chest pain (right side); Day 6 leg pain, numb, tingly; burning spot on leg; Day 3 tingling lips, hand; middle finger pain; Day 1 sore arm 24 hrs; Day 0 day of vaccine tingling hand post injection; This is a spontaneous report from a contactable healthcare professional, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the arm left on 19Mar2021 at 14:45 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included latex allergy and sulfonamide allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 14:45, the patient experienced tingling hand post injection. On 20Mar2021, the patient experienced sore arm 24 hrs. On 21Mar2021, the patient did not experience anything. On 22Mar2021, the patient experienced tingling lips, hand and middle finger pain. On 23Mar2021, the patient experienced middle finger pain, tingling and burning spot on leg. On 24Mar2021, the patient did not experience anything. On 25Mar2021, the patient experienced leg pain, numb, tingly. On 26Mar2021, the patient experienced finger pain. On 28Mar2021, the patient experienced finger pain, chest pain (right side). On 30Mar2021, the patient experienced tingling left shoulder. On 31Mar2021, the patient experienced decreased sensation. On 01Apr2021, the patient experienced weakness with workout or grip. On 02Apr2021, the patient experienced sharp shooting pain left back. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events tingling hand post injection, sore arm, tingling lips, hand, middle finger pain tingling/burning spot on leg, leg pain, numb, tingly, finger pain, chest pain (right side), tingling left shoulder, decreased sensation, weakness with workout or grip and sharp shooting pain left back were not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
36 2021-07-22 loss of smell, loss of taste 7/13/21: sore throat, low energy, cough 7/14/21: low energy, cough, fever, muscle aches, chills, los... Read more
7/13/21: sore throat, low energy, cough 7/14/21: low energy, cough, fever, muscle aches, chills, loss of taste & smell - PCR test administered 7/15/21: low energy, cough, fever, no taste or smell, sore from coughing fits 7/16/21: energy regained, fever gone, occasional cough, stuffy nose, no taste or smell 7/17/21-present: occasional cough, occasional stuffy nose, very little taste or smell
36 2021-07-22 vision blurred Client received second dose of Covid vaccine @3:39pm, complained of tingling feeling in chest and bl... Read more
Client received second dose of Covid vaccine @3:39pm, complained of tingling feeling in chest and blurred vision. Client was vaccinated in zero-gravity chair, given water to drink. Vital signs stable. At 4:14pm client complained of internal itching, dizziness, blurred vision. Vital signs stable, denied shortness of breath and difficulty breathing. At 4:24 pm client offered Benadryl, she declines, reports less tingling , no itchiness, complains of headache, sore arm, less tingling. At 4:30pm, client attempts to stand up, would like to go home. Client reports dizziness. Back in chair and observed. Vital signs are stable. Client able to go home @4:35 pm with steady gait and support person, client reports only headache and sore arm at injection site.
36 2021-07-23 visual impairment, taste disorder NVD/ emesis; nausea/ NVD; NVD; Visual/Neuro concerns; Visual/Neuro concerns; SOB; lightheadedness; f... Read more
NVD/ emesis; nausea/ NVD; NVD; Visual/Neuro concerns; Visual/Neuro concerns; SOB; lightheadedness; funny taste in mouth; Tachycardia; flushed; This is a spontaneous report from a non-contactable other healthcare professional. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7534) via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that during her 15 originally but ended up for 30 due to how she was feeling waiting period after the injection, the patient began to experience lightheadedness and nausea with brief "funny taste in mouth". She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, facial swelling, lip swelling and tongue swelling. + Nausea: + Lightheaded Tachycardia present. Flushed. Treatment included: water and Pepcid, Zofran. Follow up response to treatment. Patient discharge: Transported to ED by ambulance. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns). Patient was unable to tolerate PO fluids. Emesis frequency not changed. Discussed with patient about options, she wished to be taken to ED. Husband and daughter will meet her there. ED manager updated. Outcome of the event vomiting was not recovered while unknown for the other events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: There is a reasonable possibility that the event vomiting was related to BNT162b2 based on known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
36 2021-07-25 ringing in ears 6 weeks after developed tinnitus and headaches
36 2021-07-27 mouth ulceration pt is a 36 y.o. woman with no significant medical history admitted for progressive fevers, rash, ora... Read more
pt is a 36 y.o. woman with no significant medical history admitted for progressive fevers, rash, oral ulcers, and diarrhea over the past 3-4 weeks -- symptoms started 2-3 days after first dose of covid vaccine. Rheumatology was consulted to evaluate for SLE. She had initially been placed on broad spectrum antibiotics which have been since discontinued as no infectious etiology has been demonstrated. Her labwork on presentation were notable for AST/ALT elevation and hyponatremia. The latter has improved and the former has been variable but trending towards improvement. She also had marked pancytopenia with lymphopenia (ANC>500). Her liver US was normal. She has not had intraluminal evaluation of her colon. Her rheumatologic workup is notable for pending ANA and dsDNA, elevated cardiolipin and B2-glycoprotein, Ro60 1374.60, RNP 172.6, Sm 621.8, ESR 28, CRP negative, C3 24.8, C4 6.48, positive Coombs, negative Jo1, and pending histone. Urine had low spec grav but othwerise bland but UPC 0.63. Ms. most definitely meets criteria for systemic lupus erythematosus. It is possible that interferon upregulation after Covid vaccination may have been antecedent cause for this presentation. Given fevers and diarrhea in the setting of lymphopenia, we would be concerned for her presentation being confounded by a gastrointestinal infection acquired after her acute lupus flare. Lupus enteritis is an overall not common sign of acute lupus (only case reports). We recommend gastrointestinal evaluation before high dose immunosuppression to rule out any other causes such as autoimmune hepatitis given elevated LFTs and diarrhea. Since she is not having diarrhea currently on her abdominal exam is completely benign, a CT of the abdomen can likely be avoid for now. It is even possible that her diarrhea was due to antibiotics. Given the assurances of the evaluation and negative serologic workup thus far, we would consider initiating prednisone 40 mg daily to be titrated outpatient. We would also obtain TPMT for possible initiation of long-term immunosuppression in the outpatient setting. She does have oral thrush and should be treated with that for now with nystatin. An EGD should be considered if she develops odynophagia. Her proteinuria is concerning for renal involvement. Lupus nephritis Class V confirmed by biopsy
36 2021-07-29 feeling of choking My throat began to tingle and close slightly; My throat began to tingle and close slightly; cough; I... Read more
My throat began to tingle and close slightly; My throat began to tingle and close slightly; cough; I also became hoarse.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 13:00 (Batch/Lot Number: EW0158) as dose 1, single for covid-19 immunisation. Medical history included asthma, migraines, shellfish allergy and allergy to sulfa drugs. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), and ipratropium bromide. The patient had no other vaccine in four weeks and no covid prior to vaccination. On 08Apr2021 at 13:15, the patient's throat began to tingle and close slightly and she developed a cough, generally experienced when she has an allergic reaction to shellfish. She also became hoarse. This occurred 10 mins after receiving her vaccine (as reported). She had to administer her epipen and the EMT took her to the ER for additional medication. The events resulted in emergency room/department or urgent care and was treated with epipen and an IV of benadryl and prednisone. The patient was not tested for covid post vaccination. The outcome of the events was recovered on an unspecified date.
37 2021-01-03 eye bleeding 48 hours after injection developed micro-hemorrhages in her right eye. Symptoms resolved and 12/29 ... Read more
48 hours after injection developed micro-hemorrhages in her right eye. Symptoms resolved and 12/29 recurrence of bleeding to right eye slightly worse than before.
37 2021-01-03 mouth numbness, ear itchiness After~50 minutes from receiving the vaccine, I experienced bilateral numbness of the ears, cheeks, a... Read more
After~50 minutes from receiving the vaccine, I experienced bilateral numbness of the ears, cheeks, and tongue. This lasted ten to fifteen minutes followed by mild itching of the ears, face, and neck. Upon returning home, contacted my primary physician to report the adverse reactions and self administered Benadryl which eliminated the s/s thus far.
37 2021-01-03 mouth numbness, swollen tongue Patient developed tongue numbness, anxiety, stated that she felt her tongue was swelling up. RN and ... Read more
Patient developed tongue numbness, anxiety, stated that she felt her tongue was swelling up. RN and paramedic evaluated patient, VSS, tongue showed no signs of swelling, no acute signs of allergic reaction. Sat with patient for a few minutes, she calmed down and stated her tongue did not feel numb anymore. After waiting at clinic for 10 more minutes patient felt okay to go home.
37 2021-01-03 mouth numbness Call to EE 12/22 regarding facial numbness/ tingling after vaccine. Notes she received vaccine 12/18... Read more
Call to EE 12/22 regarding facial numbness/ tingling after vaccine. Notes she received vaccine 12/18. Was fine for first 15 minutes. Within 5-10 minutes of leaving, ee had facial numbness to right side of face and under bottom lip. Sx lasted about 3 hours and resolved 100%. No recurrence.
37 2021-01-03 mouth tingling Flushed cheeks, tingling to lips
37 2021-01-03 mouth tingling Started having tingling in her mouth, post nasal drip, and feeling like her skin in her mouth was sl... Read more
Started having tingling in her mouth, post nasal drip, and feeling like her skin in her mouth was sloughing off an hour later.
37 2021-01-03 tongue itchiness 5 minutes after the injection - felt a wave of tingling over upper body and itchy in back of throat.... Read more
5 minutes after the injection - felt a wave of tingling over upper body and itchy in back of throat. 10-15 minutes later, it happened again. Denies shortness of breath, some itchiness on tongue. Tongue was not swollen. Advised to take oral Benadryl. Total monitoring time = 40 minutes and was discharged/released home.
37 2021-01-04 loss of taste, loss of smell headache, fever 101.9, head congestion, loss of taste & smell, tested for COVID-19 on 1/04/2021 and ... Read more
headache, fever 101.9, head congestion, loss of taste & smell, tested for COVID-19 on 1/04/2021 and it was negative
37 2021-01-04 loss of smell tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; tested po... Read more
tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; sinus infection; tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; Her nose being stuffed; tension headache on the back of head; her deltoid was hurting for 24 hours; active infection after getting the first dose; This is a spontaneous report from a contactable pharmacist (patient). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right deltoid on 18Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient had active infection after getting the first dose, consult if it was still recommended to get the second dose next week or she should be delaying getting the second dose. The patient got the COVID vaccine on the 18Dec2020. Then on the 24Dec2020 she tested positive for the COVID virus. She was due to get the second vaccine on 08Jan2021. She was asking should she still get the 2nd dose of the vaccine since came up positive. The patient was having a symptom, she lost her sense of smell of 22Dec2020. She lost her sense of smell on the evening on 22Dec2020, it still had not come back at all. She did have sense of taste on the tongue. She thought it was sinus infection, because her head didn't hurt and she was not stuffed anymore. She stated that after the vaccine, she had a tension headache on the back of head, and her deltoid was hurting for 24 hours. Her headache started the same day in the evening, went on till lunch time next day. Her nose being stuffed which she thought was a sinus infection started on Tuesday 22Dec2020, it was more located in the front middle of her forehead. Her nose being stuffed which she thought was a sinus infection started on Tuesday 22Dec2020, it was more located in the front middle of her forehead. She did not have her Card to provide Lot and Expiry, it was at work at the hospital. She was administered the vaccine on the right deltoid, since she didn't want to sleep on it. Prior to vaccine she has had no positive test for Covid. Caller stated that this was super unfortunately coincidental. She had had no antibody test. She had no reactions to vaccines in the past. Test: Respiratory Panel. Result: Negative on unknown date. The outcome of events drug ineffective, COVID-19 and sinus infection was not recovered. The outcome of event tension headache and muscle pain was recovered in Dec2020. The outcome of rest events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the reported events of LOE, COVID 19 and other events, based on temporal relationship. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
37 2021-01-04 eye twitching Eye Twitching
37 2021-01-04 lip swelling, swollen tongue Facial swelling/tingling, lip swelling and tingling and tongue swelling
37 2021-01-04 mouth tingling, tongue disorder Felt tongue tingle; had a weird sensation on tongue. At first I thought I was tasting something but ... Read more
Felt tongue tingle; had a weird sensation on tongue. At first I thought I was tasting something but I wasn't; felt a bit of nausea which is a normal side effect; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 29Dec2020 09:30 at single dose for COVID-19 immunization. No medical history. No known allergies. The patient's concomitant medications were not reported. The patient felt tongue tingle and had a weird sensation on tongue. At first she thought she was tasting something but she wasn't. This lasted for about 30 mins. She also felt a bit of nausea which was a normal side effect. She was not sure what the tongue feeling was. Events onset date was 29Dec2020 10:00. No treatment received. This report is non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on an unspecified date.
37 2021-01-05 dry throat, dry mouth, mouth numbness, swollen tongue 8:00 am: tongue numbness and reported to observer 8:05 am: tongue swollen lips numb 8:10 am: registe... Read more
8:00 am: tongue numbness and reported to observer 8:05 am: tongue swollen lips numb 8:10 am: registering in ER tachycardia. Throat mouth dry and tight change to hoarse voice lightheaded. EpiPen administered. Ekg done. Other meds provided: 500 ml saline bolus. Famotidine, prednisone, benadryl Angioedemia and readmittance to ER approximately 18hrs later: prednisone,epipen, benadryl iv and po, famotidine, saline bolus
37 2021-01-05 mouth tingling Parasthesias began in my lower extremities intermittently about 36 hours following administration. T... Read more
Parasthesias began in my lower extremities intermittently about 36 hours following administration. These spread to my upper extremities and became consistent. Occasionally will appear in lips and trunk. These are associated with sensation of numbness and some discomfort in my extremities. I'm also experiencing significant brain fog, difficulty concentrating, and fatigue. Headaches are occurring about every other day. Symptoms are present currently and have remained relatively consistent in severity. Was evaluated by urgent care on December 28 and encouraged to observe. Was evaluated in the ER by neurology on January 4. There leading hypothesis is vaccine related immune response. Neurologic exam was largely normal, being evaluated by a specialist in the coming days.
37 2021-01-06 permanent deafness Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ... Read more
Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; This is a spontaneous report from a contactable physician (patient). A 37-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 17:15 at single dose on her left arm for covid-19 immunization. Medical history included known allergies to penicillin. The patient had no other medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient was not received list of any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection on 23Dec2020. These events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient had received prednisone to treat the events. The outcome of the events was not recovered.; Sender's Comments: A possible contribution role of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of sensorineural hearing loss in left ear and headache cannot be excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
37 2021-01-06 swollen tongue had side effects of "tongue feels swollen and globus sensation in my throat."; had side effects of "... Read more
had side effects of "tongue feels swollen and globus sensation in my throat."; had side effects of "tongue feels swollen and globus sensation in my throat."; she did not have a lot of injection site pain, it very minimal.; bruise or ecchymosis at the injection site; bruise or ecchymosis at the injection site; This is a spontaneous report from a contactable physician (patient) via a Pfizer sponsored program Pfizer First Connect. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) via intramuscular on 19Dec2020 09:00 on left deltoid at a single dose for COVID-19 prophylaxis. The patient medical history, family history and relevant tests were reported as none. Current concomitant medications included multivitamin took 2 chewable gummies sporadically for years as supplementation therapy. The patient previously took Flu shots she got a sore arm. It was not bad. Tetanus gives her a sore arm, but that was all. Caller wanted to know what she should do for preparation to safely get second dose of Covid vaccine and how to fix what she was feeling right now, making sure it doesn't get worse, considering she is still having symptoms. Caller stated that she had side effects of tongue felt swollen and globus sensation in her throat. The transferring agent stated that he has a caller on the line that was calling about the Covid-19 Vaccine and reported that the patient got the shot on the 19Dec2020 and was inquiring about to proceed with her weird side effects. Caller had not told her physician about her symptoms yet. Caller clarified that she said a half an hour after the dose on 19Dec2020 09:30 she said that she had a Globus sensation or like a lump in her throat. Caller also reported that the back of her tongue felt swollen. Caller said that the Globus sensation was intermittent and it was not as prominent now as it was. Caller said that it was medically significant, but she has not sought medical treatment yet. Caller said that she still had a bruise or ecchymosis at the injection site. She said that the injection was high but reported that she did not have a lot of injection site pain, it very minimal. No emergency room or physician office required. The outcome of the event tongue felt swollen and globus sensation in her throat was recovering and the outcome of the event a bruise or ecchymosis at the injection site was not recovered and the outcome of the event minimal injection site pain was unknown.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the events. Causality cannot be completely excluded.
37 2021-01-06 tunnel vision, mouth tingling Pfizer BioNTech COVID-19 Vaccine EUA; when patient was in 15 minute observation she reported feely d... Read more
Pfizer BioNTech COVID-19 Vaccine EUA; when patient was in 15 minute observation she reported feely dizzy and getting "tunnel vision." Patient sat down on the floor of her own accord without injury or difficulty. Had patient elevate her legs above heart level. Checked patients vitals, her blood pressure was low, but O2, respiration and pulse were within normal range. Patient was shaking and reported her tongue felt "tingly" and "heavy on my chest." Patient reported she had a smoothie prior to coming in for her appointment. She was given sprite. Patient felt better, but approximately 7 minutes later reported her stomach felt queezy. Blood pressure had improved and other vitals were still stable. Patient still reported her tongue felt "tingly," but no swelling, trouble breathing, or throat tightness. Patient was picked up by her father 45 minutes later and was able to ambulate to the car (with supervision) of her own accord without assistance.
37 2021-01-07 teeth hypersensitivity, tongue discomfort, mouth tingling started feeling "funny" about 30 minutes after her second covid vaccine. She returned to the covid v... Read more
started feeling "funny" about 30 minutes after her second covid vaccine. She returned to the covid vaccine clinic at 0928. She had returned to work in the clinic and let her coworkers know how she was feeling. She was given 50 mg PO liquid Benadryl at 0907 due to tingly, full-feeling tongue, and stated her "teeth and face feel funny". VS at 0915: BP 128/85, P 88, O2 100%. VS 10 mintues later (30 min after Benadryl) were: BP 118/74,P 77,O2 100%. She reports that the tingling and fullness of her tongue is much better. Her color is normal, and she is visiting with staff. Will plan to monitor for one hour.
37 2021-01-07 swelling of eyelid Reported itchy face covered with hives and one over eyelids very swollen. She was prescribed prednis... Read more
Reported itchy face covered with hives and one over eyelids very swollen. She was prescribed prednisone and symptoms resolved. Provided pictures in the email. She said her doctor advise not to take 2nd dose.
37 2021-01-07 swollen tongue tongue swelling, throat swelling chest tightness, itching neck
37 2021-01-07 ringing in ears Ears ringing, fatigue, diarrhea, headache and dizziness
37 2021-01-07 vision blurred Reaction: Dizziness, heart palpitations (HR in the 120s), blurry vision Onset: 15 min post vax Treat... Read more
Reaction: Dizziness, heart palpitations (HR in the 120s), blurry vision Onset: 15 min post vax Treatment: Observation, fluids, food Summary: Sxs resolved after one hour of close monitoring Reported history of allergies: No, but pt had hx of new onset arrhythmia a few months prior
37 2021-01-08 mouth tingling After a few minutes of administration, I felt tingling down my right arm, my right side of the face,... Read more
After a few minutes of administration, I felt tingling down my right arm, my right side of the face, and my tongue. My eye started to hurt with pressure. The tingling in my arm and hand went away after 30 minutes or so but there was still some tingling of my face, toungue and the pressure of the eye still remained. That night I took a Zyrtec and felt better for a few days. on 1/8 I started to feel tinging in my tongue and pressure in my right eye again. I took Zyrtec that night and it went away. Currently this morning I feel okay and hope it wont come back.
37 2021-01-08 taste disorder Headache fatigue, medication taste in throat, taste sensation off Narrative:
37 2021-01-09 swelling around the eyes I woke up this morning with swelling (angioedema) around my eyes. I took 50 mg of Benadryl and the s... Read more
I woke up this morning with swelling (angioedema) around my eyes. I took 50 mg of Benadryl and the swelling reduced, but isn't gone. About an hour after Benadryl I had some shortness of breath and dizziness that improved with sitting down. I have also had stomach cramping and diarrhea that began aroun noon. Diarrhea symptoms have improved with use of Imodium.
37 2021-01-10 loss of taste, loss of smell Complete loss of smell and taste; Complete loss of smell and taste; This is a spontaneous report fro... Read more
Complete loss of smell and taste; Complete loss of smell and taste; This is a spontaneous report from a contactable physician reported for herself. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: PfizerbioNtech, lot number: EH9888) intramuscularly at left arm on 17Dec2020 at 03:00 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history was reported as none. No known allergies (no allergies to medications, food, or other products). The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse event complete loss of smell and taste on 19Dec2020 at 07:00 AM. The event was considered as serious due to resulted in disability or permanent damage. No treatment received for the event. The outcome of event was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events complete loss of smell and taste cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-01-10 loss of taste, mouth discomfort, lip itchiness Approximately 15 minutes after receiving the vaccine, client started c/o itching to face and lips. T... Read more
Approximately 15 minutes after receiving the vaccine, client started c/o itching to face and lips. Transported to triage area. Where she started c/o burning lips also. vital signs monitored, Benadryl 50mg po given. In a few minutes she reported chest tightness, labored breathing. 1:44pm Epinephrine was given IM. client was on 02 increased to 15 Liters. She admits to decreased chest tightness and itching of face improving. She was taken by ambulance to hospital, where she was admitted overnight for observation. She was given Benadryl and epi X2 more time, once in ambulance and once at the hospital. She denies any problems since then. She did say that approx 3 weeks ago she was a contact to a case of covi
37 2021-01-10 dry mouth Chills and low grade temp of 99.9 Friday evening. Reports extreme dry mouth, headache, and body ach... Read more
Chills and low grade temp of 99.9 Friday evening. Reports extreme dry mouth, headache, and body aches. Motrin taken on Saturday and Sunday with improvement.
37 2021-01-10 lip swelling, swelling around the eyes, ear congestion COVID Vaccine #1 given to me in my left arm at 12:20pm -( I pre treated at 1140 am with 25 mg of Ben... Read more
COVID Vaccine #1 given to me in my left arm at 12:20pm -( I pre treated at 1140 am with 25 mg of Benadryl) At 2:25pm I began to feel a burning sensation in my chest (almost like heartburn) however I had not eaten anything. At 2:30pm I became very congested (nasal congestion and bilateral ear congestion) At 2:35pm I began coughing and could hear a wheezing sound when breathing in. -I took another 25 mg tablet of Benadryl At 2:45pm I took 20mg of Pepcid At 315 pm I went to sleep I woke up at 6:30 pm and my eyes were puffy , and my lip were enlarged and swollen. No pain or discomfort All other symptoms (chest burning sensation, coughing, congestion, wheezing) resolved. At 645pm I took 25mg of Benadryl Slept all night Woke up at 630am on 1/9/2021 and all symptoms including facial swelling, enlarged lips, chest burning sensation, coughing, congestion and wheezing had resolved.
37 2021-01-10 mouth tingling Trouble swallowing, tingling around the mouth within 5 minutes of vaccine administration. IV starte... Read more
Trouble swallowing, tingling around the mouth within 5 minutes of vaccine administration. IV started with 25mg Benadryl within 5 minutes of symptom onset. Transfer to ER at 1430. Symptoms unresolved, hr - 120, bp 140/100, O2 sats 100, resp: 21 Additional 25mg Benadryl, 125mg solumedrol, 1ml Ativan given IV at 1435. Symptoms began to resolve, patient discharged at 1600 to home with instructions to return if needed. Patient returned to ER Sunday January 10 at 1300 complaining of throat tightness. Patient was seen by doctor, no acute distress and airway issues seen. Patient elected to stay for 50mg benadryl and 40mg prednisone PO. Patient was discharged to home with script for 40mg prednisone q day for 3 days. Patient feels any remaining allergic symptoms have resolved.
37 2021-01-11 loss of smell, loss of taste Lost complete sense of smell - Lasted 15 hr; smell and taste muted after they came back. 30 -36 hour... Read more
Lost complete sense of smell - Lasted 15 hr; smell and taste muted after they came back. 30 -36 hours after vaccine - Really bad nasal congestion - bad cough and those lasted 4 days. Urgent Care. Tested for COVID -Sunday, 27th, afternoon. Tested negative for Covid. Still do have muted taste and smell but don't have cough anymore.
37 2021-01-11 loss of smell Lost complete sense of smell - Lasted 15 hr; smell and taste muted after they came back. 30 -36 hour... Read more
Lost complete sense of smell - Lasted 15 hr; smell and taste muted after they came back. 30 -36 hours after vaccine - Really bad nasal congestion - bad cough and those lasted 4 days. Urgent Care. Tested for COVID -Sunday, 27th, afternoon. Tested negative for Covid. Still do have muted taste and smell but don't have cough anymore.
37 2021-01-11 eye twitching left sided facial numbness, hyperesthesia, and left eye twitching
37 2021-01-11 taste impairment The patient informed me right after she got the vaccine that she felt cold and tingly like after ane... Read more
The patient informed me right after she got the vaccine that she felt cold and tingly like after anesthesia. She also reported a metallic taste in her mouth. She was given water and observed for 30 minutes. I called and left a message for her on 1-12 to see how she was doing.
37 2021-01-11 ear pain Dizziness/nausea, migraine headache, loss of appetite, itchy throat, ear pain
37 2021-01-11 eye movement disorder 16 hours post vaccine, I awoke to chills/feeling of fever. I suddenly felt nauseous. I went and sat ... Read more
16 hours post vaccine, I awoke to chills/feeling of fever. I suddenly felt nauseous. I went and sat on the floor of my bathroom and went unresponsive. Per my husband. My eyes rolled back in my head, my body went limp, and I was moaning. I did not come to for 30-60 seconds despite shaking, calling my name, and sticking his finger in my throat. I came to and was alert and oriented but have no recollection of the incident. EMS was called.
37 2021-01-11 mouth numbness, mouth tingling, dry mouth 5 minutes post vaccine experienced tingling lips and dry mouth; 5 minutes post vaccine experienced t... Read more
5 minutes post vaccine experienced tingling lips and dry mouth; 5 minutes post vaccine experienced tingling lips and dry mouth; 6 hours followed by lip numbness still occurring (23 hours post vaccine so far); This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO142), via an unspecified route of administration on 06Jan2021 16:45 at single dose at right arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies to medications, food, or other products. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. The patient experienced 5 minutes post vaccine experienced tingling lips and dry mouth x 6 hours followed by lip numbness still occurring (23 hours post vaccine so far) with outcome of recovered with lasting effects in Jan2021. Patient received Benadryl 37.5mg x 1 dose for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report is considered non-serious.
37 2021-01-11 mouth numbness Angioedema; Tongue numb observer notified about 10 minutes after vaccine, then tongue and Lower lips... Read more
Angioedema; Tongue numb observer notified about 10 minutes after vaccine, then tongue and Lower lips numb; tachycardia with throat tightness; tachycardia with throat tightness.; This is a spontaneous report from a contactable nurse (patient). The 37-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), unknown on 05Jan2021 07:45 at SINGLE DOSE on left arm for COVID-19 immunisation. The patient is not pregnant. No covid tested post vaccination. Medical history included Idiopathic angioedema, HTN, PCOS, Allergies to medications, food, or other products: Latex, penicillin, coconut. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included spironolactone (ALDACTONE), fexofenadine hydrochloride (ALLEGRA), hydrochlorothiazide, amlodipine besilate (NORVASC). The patient did not take other vaccine in four weeks. The patient experienced Angioedema event occurred approximately 18 hrs later with repeat of treatment in ER on 06Jan2021, tongue numb observer notified about 10 minutes after vaccine, then tongue and lower lips numb on 05Jan2021 08:00, taken to ER became tachycardia with throat tightness on 05Jan2021 08:00. EPIPEN administered, benadryl and prednisone (steroids), and famotidine administered along with a saline bolus. The outcome of the events was recovered. No follow-up attempts are needed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the angioedema and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including complement levels, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-01-11 mouth tingling Focused breathing, periodic SOB, tingling in the mouth
37 2021-01-11 visual impairment Pfizer-BioNTech COVID-19 Vaccine EUA 8hrs-40hrs after injection: fever (ranging from 102-104) chill... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 8hrs-40hrs after injection: fever (ranging from 102-104) chills, body aches, fatigue/weakness, loss of appetite, headache, vision changes, swollen right axillary lymph node (hard, painful) 40hrs-60hrs after injection: fever steady around 101, headache, fatigue, swollen right axillary lymph node (no longer hard, more disperse, still painful) 60+ hrs after injection: swollen right axillary lymph node (disperse, painful, bruising/discoloration) emailed ob/gyn about concern for swollen lymph node turning into mastitis, but referred to PCP
37 2021-01-12 eye swelling received the second dose in less than 21 days from the first dose; cervical lymphadenopathy; Swelli... Read more
received the second dose in less than 21 days from the first dose; cervical lymphadenopathy; Swelling at location of undereye cosmetic fillers; This is a spontaneous report from a contactable Physician (reporting for herself). A 37-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), intramuscular on right arm, on 04Jan2021 (lot no: EL1283) 17:00 at a single dose for COVID-19 immunization. Medical history included prolactinoma an patient had infertility. Concomitant medication included ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ascorbic acid;betacarotene;cupric oxide;manganese sulfate;selenium;tocopheryl acetate;ubidecarenone;zinc oxide]), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ascorbic acid;betacarotene;calcium sulfate;colecalciferol;cyanocobalamin;ferrous fumarate;folic acid;nicotinamide;pyridoxine hydrochloride;retinol acetate;riboflavin;thiamine mononitrate;tocopheryl acetate;zinc oxide]), levothyroxine sodium (SYNTHROID), colecalciferol (VITAMIN D [colecalciferol]).; all on unspecified dates (reported as taken within 2 weeks of vaccination) for unspecified indications. The patient had her 1st dose on right arm (lot no: EJ1685, expiry: unknown) of COVID-19 Vaccine on 16Dec2020. She received the second dose in less than 21 days from the first dose. On 06Jan2021, patient experienced swelling at location of undereye cosmetic fillers, right worse than left with mild associated right cervical lymphadenopathy. Patient was given fexofenadine (ALLEGRA) and improvement was seen. Outcome of the events lymphadenopathy cervical and eye swelling recovering. The female was not pregnant. Patient has no COVID prior vaccination. The most recent COVID-19 vaccine was admistered at the hospital and patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19.
37 2021-01-13 eye itchiness Extremely itchy eyes and face with some swelling within 30 minutes of vaccination. Last for about 2... Read more
Extremely itchy eyes and face with some swelling within 30 minutes of vaccination. Last for about 2 hours
37 2021-01-13 eye swelling On 1/9 had cold sore outbreak on right lower lip (not new). On 1/11 at 0730 started having changes ... Read more
On 1/9 had cold sore outbreak on right lower lip (not new). On 1/11 at 0730 started having changes in hearing mostly in right ear (never happened before) Also started having headache and red/swollen area below right eye. Uncertain of all related to cold sore or possible vaccine side effect?? Never had other symptoms with cold sore outbreak
37 2021-01-13 mouth numbness "Just wanted to pass along that after my second dose on 1/12/21 I experienced the following. 15 minu... Read more
"Just wanted to pass along that after my second dose on 1/12/21 I experienced the following. 15 minutes post vaccine, my tongue went numb for approximately 30 minutes, then it resolved. 6 hours post vaccine I became very dizzy and flushed and began to feel achy. The following morning I felt well enough to come into work but then felt increasingly weak, achy, and tired and had to go home at 12pm. All side effects were resolved by 5pm. "
37 2021-01-13 bloodshot eyes, eye swelling Swelling & redness around eyes Lasted 3 hours, then went away
37 2021-01-13 pain in jaw, loss of taste, ear pain 1) The morning after the vaccine, I lost my ability to taste. It is still gone 6 days post vaccine. ... Read more
1) The morning after the vaccine, I lost my ability to taste. It is still gone 6 days post vaccine. 2) Yesterday, day 5 post vaccine, I began having a pain behind my jaw/beneath my ears bilaterally. I took ibuprofen for this, but it didn?t seem to help much.
37 2021-01-13 mouth tingling, swollen tongue Received vaccine approx 4:25pm. At approx 4:50pm, while driving home, I started to feel "off", like... Read more
Received vaccine approx 4:25pm. At approx 4:50pm, while driving home, I started to feel "off", like something was wrong. Part of my tongue started to feel a bit tingly and itchy. I arrived home approx 5 minutes later, and took Diphenhydramine 50mg po. Parts of my tongue still felt tingly and itchy, and the right side towards the back was starting to feel a little swollen. I decided to have EMS bring me to the hospital in case I was having an allergic reaction. EMS arrived to my house at approx 5:15pm. My BP was significantly elevated (160's/90's - I am usually 110's/60's), and I was tachycardic at approx 100-105bpm (I am usually 70-80bpm). I had started to feel like the back of my throat was tightening a little bit. I did not have wheezing or severe difficulty breathing, or generalized itching, hives, or flushing. Once on the ambulance my throat was feeling tighter, so they administered Epinephrine 0.3mg IM, inserted an IV, and administered Dexamethasone 10mg IV. After a few minutes the tightness in my throat was gone and I was feeling more back to normal. BP and HR began to slowly trend down (BP 130's/80'sjust prior to arrival to hospital). I was seen by Nursing and a Provider shortly after arrival to the ED. My BP was still elevated (140's/90's) and HR was approx 90bpm. Provider stated that my posterior pharynx was not swollen. I was observed in the ED for approx 2.5 hours, and was discharged to home with instructions to take Diphenhydramine as needed and follow-up with my PCP within two days. BP and HR had normalized prior to discharge. They did not do any labs or tests (12-lead EKG was done by EMS en-route). The following day (today) I am tired and have a slight headache and occasional slight nausea but otherwise feel ok.
37 2021-01-13 mouth tingling after 10 minutes developed sensation of throat swelling, tongue tingling and facial flushing: transf... Read more
after 10 minutes developed sensation of throat swelling, tongue tingling and facial flushing: transferred to ED: no intervention, observed for 3 hrs & d/cd
37 2021-01-13 visual impairment I had vertigo, unsteady gate, nausea, vomitting, difficulty with visual tracking.
37 2021-01-14 ear pain muscle pain, lightheadedness (comes and goes), nauseau (off and on), headache, right sinus/ ear pain... Read more
muscle pain, lightheadedness (comes and goes), nauseau (off and on), headache, right sinus/ ear pain, insomnia, faint chest pain, numbness right arm and leg, diarrhea, wheezing (off and on), fatigue.
37 2021-01-14 eye pain, sensitivity to light At 2000 on 1/13/21, I started to experience intense ache at the injection site, which by 2200 progre... Read more
At 2000 on 1/13/21, I started to experience intense ache at the injection site, which by 2200 progressed to myalgias in my back, especially lower back, neck, and right arm. At 2300, I started to have fever/chills, up to 39 C orally. This only partially responded to Tylenol. I was not able to sleep. At 2:30 am I noticed an unusual headache, 8/10, as well as bilateral eye pain on Moving eyes side to side as well as sensitivity to light. Headache was mostly frontal, which came and went every few minutes until exactly 11:38 am on 1/14/2021, when the fever and myalgias very suddenly got significantly better. Almost exactly 24 hrs to the minute after injection. On 1/15/2021, I still have significant pain in my left arm, swelling, redness and, now, itching at the injection site. My lower back still hurts.
37 2021-01-14 oropharyngeal discomfort ~10pm, tickle in throat ~ Midnight dry cratchy cough related to tickle in throat ~10pm, itchy wrist... Read more
~10pm, tickle in throat ~ Midnight dry cratchy cough related to tickle in throat ~10pm, itchy wrists, bilaterally, progressed to back of neck, insides of arms, lower legs, tops of feet, upper chest, under breasts, and splotchy face. ~10-midnight - rash in all same areas of itchiness
37 2021-01-14 mouth tingling Patient left after 15 minute wait time after receiving second COVID-19 vaccine. Patient then returne... Read more
Patient left after 15 minute wait time after receiving second COVID-19 vaccine. Patient then returned at 0632 to vaccine clinic stating that she was having numbness and tingling to jaw and lips and left ear. Vitals were obtained: 115/73, HR, 74, O2 Sat: 97% on RA. Patient denies any SOB of difficulty breathing. Patient has no noted welts or redness noted. 0635: Patient was given 25 mg of Benadryl, PO and patient is drinking her coffee. 0640: patient sitting up in chair, patient denies any tingling and or numbness to jaw, lips, and left ear. Patient states " I can not believe I am feeling so much better. I have no numbness at all." 0702: patient feeling much better, and denies any SOB, edema, numbness and or tingling. Patient vitals: B/P: 113/58, HR: 76, O2 Stat: 97% on RA. Patient did ambulate out of clinic with out issues. Advised patient on signs and symptoms to look out for and when to seek medical attention. Patient verbalized understanding.
37 2021-01-14 feeling of choking 12/30/2020- 5 minutes after receiving vaccination pt c/o throat tingling and tightening. Then 10 mi... Read more
12/30/2020- 5 minutes after receiving vaccination pt c/o throat tingling and tightening. Then 10 minutes later began having headache. Sent to ED- EKG completed, and pt was monitored. Declined Benadryl. Apx 5-7 pm that night when at home pt decided to take a half dose of OTC Benadryl. pt woke in middle of night still with headache-took Advil. When woke in the morning had diarrhea and stomach discomfort- lasted apx 24 hours. Then beginning on 01/04/2021 pt noticed the sensation of having a burned tongue and roof of mouth.- is constant and sensitive to heat. pt reports that intermittently in the evening she is also getting the sensation of tongue and throat swelling- denies any SOB and denies actual swelling just sensation.
37 2021-01-15 vision blurred The patient was in observation for 5-10 minutes after the vaccine. She reported that she was hot. I ... Read more
The patient was in observation for 5-10 minutes after the vaccine. She reported that she was hot. I asked her if she had any history of anaphylaxis. She said she did to morphine. Her bp was 119/74 with a pulse of 94. She said her nose was starting to get itchy, her ears and scalp were itchy, and her eyes were blurry. She had red blotches all over her neck and chest. She said her throat was tight. She was able to swallow the water she requested. I gave her 50mg of benadryl. She had no visible signs of being unable to breathe. I explained to her we could call 911. She reported she had no insurance. She said she was on her lunch break at the hospital and wanted to get back. She did walk back across the street unassisted. Clinical observer, followed her over just to verify she made it in the building. She ended up checking herself into the ER instead of returning to her shift.
37 2021-01-17 lip swelling, mouth tingling Vaccine given at approx. 1608, Patient developed full body itching, chest tightening, and tingling t... Read more
Vaccine given at approx. 1608, Patient developed full body itching, chest tightening, and tingling tongue approx. 8 minutes after the vaccine injection. Patient denies difficulty breathing or swallowing. Vitals taken: HR 88, BP 121/72, RR 20, SPO2 97% on RA. Diphenhydramine 50mg IM in left arm at 1627.. At 1700 tongue started tingling again with new hives on chest. At 1707 Hydrocortisone 100mg IM given in right ventrogluteal muscle. At 1746 patient feels no tongue tingling or lip swelling and itching has subsided, Denies difficulty breathing or swallowing. Patient released home.
37 2021-01-17 mouth tingling Patient's reaction(s) noted during COVID vaccine observation period: 15 minutes after Covid Vaccine ... Read more
Patient's reaction(s) noted during COVID vaccine observation period: 15 minutes after Covid Vaccine received, patient states that she has tingling on her lips and arms, lightheadedness, and nausea. Vitals taken; 0945: 148/86, HR 104, 100% RA, temp: 97.7 1015: 147/84, HR81, 100% RA, Temp: 98 Pt sitting comfortably in chair, drinking ice water. No further evaluation, spouse drove patient home. Disposition: Home
37 2021-01-18 dry mouth Significant dry mouth and oral sores from dry mouth- continuous and has not gone away. So bad that I... Read more
Significant dry mouth and oral sores from dry mouth- continuous and has not gone away. So bad that I got tested for Sjogren's which was negative
37 2021-01-18 swollen tongue, burning mouth syndrome Felt tachycardia immediately, thought she was anxious. After 35-45 minutes she felt like she was hav... Read more
Felt tachycardia immediately, thought she was anxious. After 35-45 minutes she felt like she was having a hard time swallowing which progressed to tongue swelling, all taste buds popped up and sore, hives on face & neck, reddened face. Itchy neck and face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling all over body. Woke up feeling heaviness as if she had "sumo wrestler" on her body. 24 hours post vaccine heaviness started to lift but felt as if she had a vise on her lungs. Continuing to take Atarax every 6 hours per MD order.
37 2021-01-18 tongue disorder low energy confused, foggy memory bumps on tongue and in mouth tired heart rate was high 120,150- hi... Read more
low energy confused, foggy memory bumps on tongue and in mouth tired heart rate was high 120,150- high 160s
37 2021-01-20 mouth itchiness Patient developed itchy hives to body 10 min post-vaccination. She also reported burning feeling to ... Read more
Patient developed itchy hives to body 10 min post-vaccination. She also reported burning feeling to her face and itchy mouth. No swelling noted or reported. Skin red.
37 2021-01-20 mouth tingling extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint... Read more
extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; fever/low grade fever; nausea; gas which lead to vomiting; gas which lead to vomiting; extreme joint and muscle aches even after 1gm of Tylenol (ankles, elbows, hips, lower back, calves were the worst)/ lower back pain; chest similar to what one would experience during hyperventilation; tingling feeling in hands/fingers, lips; tingling feeling in hands/fingers, lips; headache; Slept most of the day evening; This is a spontaneous report from a contactable nurse (reported for herself). A 37-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 08Jan2021 10:15 at single dose at right arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication received in two weeks included lisdexamfetamine mesilate (VYVANSE) in two weeks (did not take on vaccine days). The patient previously received the first dose of bnt162b2 (lot number: EJ1685) on 18Dec2020 10:00 at single dose at right arm for COVID-19 immunization. No other vaccine in four weeks. On 09Jan2021 12:00, 12hrs after injection extreme joint and muscle aches even after 1gm of Tylenol (ankles, elbows, hips, lower back, calves were the worst), fever, nausea/gas which lead to vomiting (even after 25mg phenergan) and headache this last 6hrs. The aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent. Tylenol did not relieve symptoms, but was able to sleep. Slept most of the day evening in Jan2021. 48/60hrs after injection the lower back pain remains intense as well as low grade fever (Jan2021). Also have a tingling feeling in hands/fingers, lips, chest similar to what one would experience during hyperventilation on 09Jan2021 12:00. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient didn't have Covid prior vaccination and didn't have Covid tested post vaccination. The outcome of Arthralgia and Pain in extremity was recovering, of Pyrexia and Low back pain was not recovered, of the other events was unknown.
37 2021-01-20 vision blurred Headache Beginning within 10 minutes of first injection (Pfizer Lot EL0142 administered 12/30/20) an... Read more
Headache Beginning within 10 minutes of first injection (Pfizer Lot EL0142 administered 12/30/20) and continuous, but exacerbated by second injection; Blurred vision; nausea; toe and finger cramping; chills; right eye and cheek spasm with numbness; swelling and itchiness at vaccine site; pain in left arm from second injection; fever 3 degrees above baseline
37 2021-01-21 taste impairment, mouth tingling ABOUT 15 MINUTES AFTER VACCINATION, TYHE PATIENT COMPLAINED OF ARM NUMBNESS, TINGLING IN MOUTH/TONG... Read more
ABOUT 15 MINUTES AFTER VACCINATION, TYHE PATIENT COMPLAINED OF ARM NUMBNESS, TINGLING IN MOUTH/TONGUE AND METALLIC TASTE. THE PATIENY WAS ADMINSTERED 50MG OF BENADRYL AND MONITORED FOR AN ADDITIONAL 30 MINUTES. THE PATIENT SAID THE TINGLING IN TONGUE IMMEDIATELY RESOLVED AFTER BENADRYL AND JUST HAD MINOR ARM SORENESS.
37 2021-01-21 oropharyngeal discomfort, tongue disorder About 12-13 minutes into my wait after getting the vaccination... my throat had a tickle in it... li... Read more
About 12-13 minutes into my wait after getting the vaccination... my throat had a tickle in it... like I needed to clear my throat. So I did... and then again.... and again. Then I felt dizzy and disoriented... foggy headed kind of drunk feeling. Then within what seemed like seconds... my mouth felt full so I opened my mouth and looked in the mirror. My tongue seemed bigger than usual and lighter in color. But what was most noticeable was that I had Ripples along the whole outer edge and side of my tongue. pulse ox reading was an 89 so they administered a prescription strength Benadryl shot and told me they would need to monitor me and keep an eye on me. Another woman drove me from the vaccination site to the clinic where they checked my oxygen levels again and i was already back up to 99. They monitored me and checked on me for about 15-20 minutes before releasing me. My tongue finally felt normal again about 2 hours later while resting at home.
37 2021-01-21 sensitivity to light Light sensitivity, skin sensitivity, flushed skin. My whole body itched.
37 2021-01-22 loss of smell, lip swelling, loss of taste, inability to speak, taste impairment, mouth tingling 1/7/21: had thee COVID vaccine on 1/5/20 and developed symptoms an hour after administration chills,... Read more
1/7/21: had thee COVID vaccine on 1/5/20 and developed symptoms an hour after administration chills, sweats and bodyaches. Also developed nausea, diarrhea and chest pain. Woke up this morning with cough and congestion. 1/10/21: called this morning to give us an update on her symptoms and see about a COVID swab. states that she is currently hooked up to an IV due to dehydration and no urine output. she has had zofran and pain medication for her severe abd pain. They have strep swabbed and flu swabbed but have not COVID swabbed. Encouraged getting a COVID. She states she will ask them for one and will call us with an update either today or tomorrow. 1/10/21: called and left voicemail stating that she was being discharged. they did COVID 48-72 hours for results. On ABX and Phenergan and Zofran alternating. Got two bags of LR has UTI and Kidney infection. CT with contrast lungs clear. Negative for flu and strep. Strep culture pending. added to spreadsheet since she was COVID tested. 1/14: Called regarding her Covid test. It was reported as negative. is still very sick with fever, sore throat, congestion, nausea. I spoke with Doctor regarding the extent of her symptoms following the vaccine. Doctor recommended that she be seen by her PCP as she has not improved. 1/14: called and went to her PCP as advised by Doctor. now has a UTI and URI. She is on Macrobid and Levoquin as well as Zofran and Phenergan. Her BP was 117/60 and dehydrated. Her PCP told her to monitor her BP and return to ER if not improved and also return to ER if symptoms became worse. will call on Monday 1/18/2020 and update us on her condition 1/17:COVID tests were negative, over 48 hours since a temp above 100.4, 99.1 was the last temp doing better. No more vomiting and no diarrhea. still has a cough and is still on ABX from all of her symptoms. Is on a cough suppressant so recommend her working from home since she is able and will update us towards the end of the week on how she is doing. 1/20: Received the COVID vaccine on 1/5/21. Released yesterday to work from home. No longer has vomiting or diarrhea. COVID, FLU and strep tests negative. Diagnosed with allergic reaction to COVID Vaccine. had kidney infection and UTI. CT of abdomen done with contrast. CXR to r/o pneumonia. continues to have a runny nose, no fever. Continues to have laryngitis and fatigue. called today to get released. Encouraged to call back when she gains more strength and can return. My PCP diagnosed me with a severe allergic reaction to the covid shot. I had the rapid covid test ran twice and the test sent out twice, all 4 tests came back negative. I had the flu test ran and it came back negative. So did the strep culture. I had 2 full lab workups ran and they both came back normal including my vitamin levels. The only thing that was out of alinement was my white cell count was high due to an infection. Today, I am currently running a fever of 99.4. I still have a cough that is rather irritating. I still do not have a voice. I am retaining color back in my skin. I am still tired and weak but have managed to work and do small things around the house such as cook dinner, wash laundry, clean dishes, and shower. These were daily tasks that I wasn't able to do during the first 2 weeks after taking the shot.
37 2021-01-22 mouth itchiness I developed an itchy mouth and throat, I was having difficulty swallowing. I was never asked about ... Read more
I developed an itchy mouth and throat, I was having difficulty swallowing. I was never asked about my allergies. I was administered the vaccine at 1501, and was released at 1509. When they released me, I was feeling nervous but overall fine. As I was driving home around 1515 I began having difficulty swallowing and the itchy feeling in my throat
37 2021-01-24 mouth numbness, mouth tingling Pt given 2nd Covid vaccine. Stated she had lip tingling/numbness and left sided facial numbness. No ... Read more
Pt given 2nd Covid vaccine. Stated she had lip tingling/numbness and left sided facial numbness. No SOB, no difficulty breathing or airway issues. 25 mg IM benadryl given at 17:33. Currently at 18:13 pt states it is not getting worse and the numbness is currently over her left eye brow and chin. Pt stated she feels comfortable to leave but pt was advised to wait.Pt stated that after her first vaccine she had some numbness on right side of face that lasted 3 days post injection but no difficulty breathing or with airway. She had read on line that 1% of people may get numbness so felt comfortable getting second dose since she had no airway problems. At 18:29 pt left, refused to go to ER per clinic recommendations.
37 2021-01-24 mouth tingling, lip swelling Received vaccine dose #2 1/21/2021 around 3:30pm. Woke up Friday with headache, nausea and progressi... Read more
Received vaccine dose #2 1/21/2021 around 3:30pm. Woke up Friday with headache, nausea and progressive chills and fever throughout the day. By the end of the day was feeling back to baseline. Felt normal all day Saturday and Sunday morning. Sunday afternoon around 1pm left upper lip tingling started and progressed to lip swelling and development of 3 hives to right forearm. Took diphenhydramine, famotidine, ibuprofen and cetirizine at home. Hives did not progress and lip swelling seemed to subside a little. Woke in the night around 3:30am with itching. Eyelids were swollen, hands very swollen with painful palms, new hives to groin, axilla, buttocks. Sought care at ED. No other identifiable cause for reaction, no new food, soap, detergent, exposure etc.
37 2021-01-24 mouth tingling suspect that it may be Bell's Palsy; tingling in the left side of her tongue; This is a spontaneous ... Read more
suspect that it may be Bell's Palsy; tingling in the left side of her tongue; This is a spontaneous report from a contactable nurse. A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly at 0.3ml single injection in the left arm on 22Dec2020 09:00 for covid-19 prophylaxis. Medical history included persimmon fruit allergy from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced tingling in the left side of her tongue on 22Dec2020, the event was reported as serious per medically significant, suspect that it may be bell's palsy on an unspecified date. The adverse event was not required a visit to emergency room or physician office. Caller was an employee health nurse that reported that she had an employee that received the first dose Covid-19 vaccine on 22Dec2020 and as they were administering the vaccine, the patient developed tingling in the left side of her tongue. The caller said that the patient reported that the tingling was still there. She said that the patient was concerned that it might cause her to get bell's palsy. Caller wanted to know if this was this common and whether she could move forward with getting the 2nd dose of the vaccine. The caller said that the patient received the vaccine in her left arm. The caller said that the patient reported that the tingling in her tongue was mild and not stopping her from eating and she was not having any respiratory issues. Caller said that the only allergy that the patient has was to Persimmon fruit. The side effect mentioned is not necessarily Bell's palsy since the characteristic eye drooping is not present. The outcome of events for tingling in the left side of her tongue was not resolved, for suspect that it may be bell's palsy was unknown. Vaccination Facility Type was hospital. Vaccine Administered at Military Facility: No. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No relevant tests. Drug result was related.; Sender's Comments: The causality between the reported tingling in the left side of her tongue, which was suspected that it may be Bell's Palsy and the administration of COVID-19 vaccine, BNT162B2, cannot be denied, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
37 2021-01-24 mouth tingling Patient reported that after dose 1 she was observed due to stated allergies. Approximately 10 minut... Read more
Patient reported that after dose 1 she was observed due to stated allergies. Approximately 10 minutes into this observation she reported tingling around her lips that resolved within approximately 20 minutes. She does not feel she was anxious and hyperventilating when this occurred. She was released and went back to work. Within approximately 30 minutes of being back to work her coworker commented that she had hives on her forehead. These were described as two blotchy areas and were slightly pruritic. They resolved without treatment within approximately one hour.
37 2021-01-25 lip swelling Diffuse Urticarial rash, worsening day 3 despite PO dexamethasone, Allegra, Zyrtec and Benedryl. Rec... Read more
Diffuse Urticarial rash, worsening day 3 despite PO dexamethasone, Allegra, Zyrtec and Benedryl. Received IV benedryl due to swollen lips in the ER.
37 2021-01-26 taste impairment Pt presented to COVID vaccine clinic today and developed a mild reaction after receiving her first P... Read more
Pt presented to COVID vaccine clinic today and developed a mild reaction after receiving her first Pfizer vaccination. Denies hx of known allergies or hx of anaphylaxis reactions. Pt reported palpitations and metallic taste in mouth 15 minutes after receiving the vaccination as well as a slight tightness sensation in her throat like there was something stuck in her throat. Metallic taste resolved after a few minutes. Pt denied SOB, swelling of face/tongue/throat, difficulty swallowing, nausea, rash, itchiness, dizziness. No visible swelling. BP: 127/66 HR: 80 O2: 100% Paged Allergy. Pt advised to stay for 30 more minutes and reassess. After 30 minutes pt reported palpitations had resolved. Throat symptoms improved but not completely resolved. Paged Allergy again to check in. Advised to give Zyrtec 10 mg and observe to see if there is any improvement
37 2021-01-26 eye pain, photosensitivity reaction itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles);... Read more
itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles); nausea; chills; fever/chills (up to 39 C); myalgias in the back and contralateral arm; left arm soreness; Redness and swelling at injection site; Redness and swelling at injection site; Lower back pain; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot: EK9231) on 13Jan2021 11:45 at a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), environmental allergies, Penicillin (but not augmentin) allergies and sulfa allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole, and vitamin d. Histrical vaccine included the first dose of BNT162B2 (lot number: EJI685) on 23Dec2020 12:15 in the left arm, for covid-19 immunization. On 13Jan2021 20:00, patient experienced left arm soreness. Then at 21:00, she experienced myalgias in the back and contralateral arm. At 23:00, she had fever/chills (up to 39 C). The next day (14Jan2021) at 2:30, she had frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), persistent fever and nausea. All these symptoms persisted until exactly 11:48 on 14Jan2021, when everything suddenly got better. Still occasional chills but no fever for the rest of the day, left arm pain persists into 15Jan2021. Redness and swelling at injection site are worse. There was also now itching. Lower back pain persists. The outcome of events left arm soreness, "Redness and swelling at injection site" and lower back pain was not recovering. She was recovering from " myalgias in the back and contralateral arm", fever/chills (up to 39 C), frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), nausea, chills Patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
37 2021-01-26 mouth numbness Started feeling throat tighten and lips go numb. She was given Benadryl 25 mg orally at 2:36. This... Read more
Started feeling throat tighten and lips go numb. She was given Benadryl 25 mg orally at 2:36. This did not start releaving the symptoms and epi 0.3mg was given IM at 2:45pm. This began to work and her upper lip numbness begin releaving at 2:53PM. She told us that she used epi and benadryl after her 1st dose but did not tell anyone.
37 2021-01-26 mouth tingling, swollen tongue Lip tingling, feeling of tongue swelling.
37 2021-01-27 taste impairment tired; slept most of the day; Headache; Chills; Joint pain; Sore throat; muscle pain/muscle ache; ar... Read more
tired; slept most of the day; Headache; Chills; Joint pain; Sore throat; muscle pain/muscle ache; arm was hurting more than sore/arm pain at injection site; Nausea; Loose stools; Left eye twitching; feeling pretty ill/ under the weather; a little short of breath/shortness of breath; Metal taste in her mouth; Itchy everywhere; asthma has flared up a little bit; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH3246, expiry date unknown), intramuscular (right arm), on 08Jan2021, at single dose, for covid-19 immunization. Medical history included asthma since 2004 (diagnosed about 17 years ago). Concomitant medication included formoterol fumarate, mometasone furoate (DULERA) (has been on this for about 2 months) for asthma. The patient previously took formoterol and budesonide (SYMBICORT) for asthma. The patient stated she was a technician and she has a couple of questions about the Covid vaccine. She got the vaccine on 08Jan2021. Since she got the vaccine, papers said she would feel under the weather for a few days but she was still feeling pretty ill; she wanted to know if this was normal and when should she be concerned, wondering if she should call her doctor. She was encouraged to reach out to her HCP for any medical advice. She also stated that 5-10 min after the vaccine on 08Jan2021, she started to feel a little short of breath/shortness of breath but that resolved. Also, afterwards on 08Jan2021 she had a metal taste in her mouth and was itchy everywhere on that day. She went home and around 9PM on the day of the vaccination, she started to feel under the weather on 08Jan2021. Then she woke up on Saturday 09Jan2021 with headaches, chills, joint pain, sore throat, muscle pain/muscle ache, arm was hurting more than sore/arm pain at injection site, nausea, loose stools, and left eye twitching. On Sunday 10Jan2021, she was very tired and slept most of the day. She added that she has been reporting this to the link that was provided to her. She has been taking Tylenol and ibuprofen to treat these symptoms and; was also using her inhaler because it seemed like asthma has flared up a little bit on Jan2021. No other vaccines administered on the same date with the Pfizer vaccine. The adverse events did not require a visit to the emergency room or physician office. No prior vaccinations within four weeks. The outcome of the events feeling pretty ill/ under the weather, slept most of the day and, asthma has flared up a little bit was unknown. The outcome of events a little short of breath/shortness of breath, metal taste in her mouth, and itchy everywhere was recovered on 08Jan2021. The outcome of joint pain was recovering. The outcome of arm was hurting more than sore/arm pain at injection site was recovered on 13Jan2021. The outcome of the other remaining events was not recovered.
37 2021-01-27 lip swelling, swollen tongue, ear pain, chewing disorder 37yo female received first COVID vaccine lt arm on 1/15/21. She denies any immediate adverse reacti... Read more
37yo female received first COVID vaccine lt arm on 1/15/21. She denies any immediate adverse reactions. Day 6 (1/22) she c/o right ear pain. 1/23 continued ear pain with nasal congestion 1/24 symptoms continue with difficulty chewing about 1100am. 1700 c/o tongue -upper lip swelling and rt facial droop, forehead-eyebrow paralysis - to ER where diagnosed with Bells Palsy. ER provider dx viral like illness and bells palsy attributed to viral prodrome. Given tapering dose prednisone, Sudafed for congestion/ear fullness and ophthalmic eye drops. Seen by HCP 1/27 and again 1/28 with improvement of symptoms but facial droop continues. Pt states is better. Prescribed Valtrax Additional information for Item 18: Medical center notified of case and monitoring.
37 2021-01-27 eye discomfort Patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine at 0710 on 1/13/21. At app... Read more
Patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine at 0710 on 1/13/21. At approximately 0740 at the end of the 30 minutes observation period, she reported right eye pressure. Benadryl 25 mg was given per clinic protocol by the clinic RN and administered. Patient stayed for another 15 minutes for observation to assess if symptoms would worsen. Of note: patient reported that on receiving the first dose of the Pfizer COVID vaccine, she experienced periorbital edema and mild tongue swelling about 20 minutes after the first dose. The symptoms were relieved following Benadryl 25 mg administration.
37 2021-01-28 permanent deafness Sudden-onset R sided sensorineural hearing loss
37 2021-01-28 eye itchiness At 4:26pm patient reported that she has itchy eyes and nose and also a runny nose. Vital signs taken... Read more
At 4:26pm patient reported that she has itchy eyes and nose and also a runny nose. Vital signs taken. Patient given Diphenhydramine by mouth at 4:33pm. Patient was discharged to go home.
37 2021-01-28 ringing in ears After 10 minutes RN walked over to recovery area and noticed that pt's face was red. She asked pt if... Read more
After 10 minutes RN walked over to recovery area and noticed that pt's face was red. She asked pt if she was ok and pt stated yes. RN never left pt side and then noticed her neck getting red and pt c/o ringing in ear. Pt was refusing to stay until she became diaphoretic and the she handed RN EPI pen to administered. RN sat patient down and administered epi to Right thigh. EMS was called patient taken to ED
37 2021-01-29 eye itchiness Approximately 8hrs after receiving vaccine I developed itchy eyes, hives around my eyes, itchy throa... Read more
Approximately 8hrs after receiving vaccine I developed itchy eyes, hives around my eyes, itchy throat. I took 2 benadryl capsules. The symptoms resolved in approximately 2 hours. I woke up the next day with some itching and 2 hives on my abdomen (approximately 21 hrs after injection). Nothing was taken and symptoms resolved on their own.
37 2021-01-30 mouth tingling Within 1 min of getting the injection I felt my heart racing , I became dizzy, my lips and tongue st... Read more
Within 1 min of getting the injection I felt my heart racing , I became dizzy, my lips and tongue started to tingle and felt weird. Then I fainted, on the floor I heard the nurse say my BP was 'dangerously low'
37 2021-01-31 eye irritation, loss of smell, eye itchiness 13 days after receiving my first shot I started with a mild cough. I thought it was allergies associ... Read more
13 days after receiving my first shot I started with a mild cough. I thought it was allergies associated with changing weather and I wasn?t running fever so I continued to go to work. Two days later I still had no fever, but got dizzy and started feeling bad. I went and got tested that night and tested positive for the virus. My eyes have itch and burned, but I still have never run and fever and didn?t loose my Sense of smell until 5 days after symptoms first started. My cough got worse and I have also had sneezing.
37 2021-01-31 lip swelling, swelling of eyelid ?Pfizer-BioNTech COVID-19 Vaccine EUA? Received second covid vaccine on 1/21 (17 days from first inj... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA? Received second covid vaccine on 1/21 (17 days from first injection) and experienced fever, chills, nausea and body aches the following morning. Symptoms resolved by the next morning and pt felt fine all day Sat and Sun morning. Sun after noon around 1pm pt's lips started to swell and developed hives to right arm. This progressed throughout the evening despite antihistamines. At about 4am Monday 1/25 pt awoke with eyelid swelling, persistent lip swelling and more hives and presented to the ED. Pt was given prednisone. Pt followed up with PCP on Tues 1/26 as hives persisted through prednisone. Symptoms have improved over the next few days. No breathing or airway symptoms.
37 2021-01-31 mouth tingling, mouth numbness Pt stated that her lips were tingling and numb, and that she felt lightheaded about 20 min after get... Read more
Pt stated that her lips were tingling and numb, and that she felt lightheaded about 20 min after getting her 2nd dose. After about 5 minutes the symptoms improved.
37 2021-01-31 mouth tingling, vision blurred, swollen tongue Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 15-20 minutes after receiving the injection, fel... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 15-20 minutes after receiving the injection, felt dizzy, nauseated, shaky. Tongue felt like it was swelling similar to previous allergic reactions I have had, lips were tingly, vision started to blur. Given 25 mg benadryl PO. Walked to urgent care in building, given IV methylprednisone and odansterone, oral famotidine. BP initially very high, was 154-100 at time of discharge from urgent care at approximately 11:30 am. Temp 97.4 at discharge. The following morning: vomiting, copious diarrhea, fever, body aches, stomach pains, fatigue, headache, weakness, dizziness, joint pain. Treated with fluids, rest, benadryl. Temperature high of 100.8 (not taking it consistently though). Today, 02.01.2021 temperature 99.8, still aches and weakness but improving. Normal temperature is ~97.7 on home thermometer.
37 2021-01-31 sensitivity to light Vaccine caused MS related symptoms which included, optic neuritis, photophobia, cluster migraines, f... Read more
Vaccine caused MS related symptoms which included, optic neuritis, photophobia, cluster migraines, fatigue, nausea, chills, confusion, diarrhea
37 2021-02-01 loss of taste, loss of smell 1/28/2021- Sever upper abdominal (stomach aches) pain, diarrhea, low grade fever (~100 F), and fati... Read more
1/28/2021- Sever upper abdominal (stomach aches) pain, diarrhea, low grade fever (~100 F), and fatigue- No intake of food- fear of adverse abdominal pain. 1/29/2021- Mild abdominal pain , diminish sense of smell and taste, and tired. Took a Covid-19 PCR test. 1/30/2021- Little abdominal pain and diminish sense of smell and taste. 1/31/2021-Diminish sense of smell and taste. 2/1/2021- Diminish sense of smell and taste. Negative PCR Covid-19 Test. 2/2/2020- Sense of smell and taste restored.
37 2021-02-01 sensitivity to light STARTED WITH STRONG HEADACHE, PHOTOPHOBIA, FEVER, BODYACHE, JOINT PAIN , LEFT ARM PAIN SINCE 2/2/202... Read more
STARTED WITH STRONG HEADACHE, PHOTOPHOBIA, FEVER, BODYACHE, JOINT PAIN , LEFT ARM PAIN SINCE 2/2/2021 12AM
37 2021-02-01 tongue itchiness, swollen tongue Patient did not receive COVID vaccine at SHG, unsure where patient received vaccine. Also, unsure wh... Read more
Patient did not receive COVID vaccine at SHG, unsure where patient received vaccine. Also, unsure which COVID vaccine patient received. Shortly after receiving COVID vaccine on 1/29/21, patient developed sensation of throat closing, tongue swelling and itching. Patient was given Epi and Benadryl by EMS and saw improvement. Patient was admitted to the ER where she received steroid and epi and was discharged home with steroids. The next day, 1/30/21, patient returns to the ER after taking EpiPen, benadryl and prednisone at home because she felt throat was closing and some itchiness. She later improved in ER stating she can now take a deep breath without issue.
37 2021-02-02 sensitivity to light, vision blurred 01/25/2021-1/26/2021: photophobia, headache, general exhaustion, left shoulder discomfort 01/31/2021... Read more
01/25/2021-1/26/2021: photophobia, headache, general exhaustion, left shoulder discomfort 01/31/2021- dyspnea, tachypnea, palpitations, nausea, indigestion, dizziness, blurred vision, tremors/shaking 02/01/2021-on-going: dizziness and intermittent blurred vision and palpitations
37 2021-02-03 taste impairment 30 mins after injection of second dose a metallic/medicinal taste was discovered in my saliva. Four... Read more
30 mins after injection of second dose a metallic/medicinal taste was discovered in my saliva. Four hours after dose began feeling nausea. Day 2 nausea and metallic/medicinal taste in saliva continued. Metallic/medicinal taste in saliva stopped mid morning of day 2. Day 2 experienced chills, headaches, elevated body temperatures, severe night sweats, and stiff body. Day 3 headaches and stiff neck. Also injected arm was very sore during the two day experience.
37 2021-02-04 mouth tingling Felt dizzy and had tingling of lips about 4 min after vaccine. VSS. Laid on cot for ~20 min. Left... Read more
Felt dizzy and had tingling of lips about 4 min after vaccine. VSS. Laid on cot for ~20 min. Left on own without assistance. Symptoms resolved.
37 2021-02-04 swollen tongue EMS evaluated treated and transported- Difficulty breathing, tongue swelling, flushing, airway swell... Read more
EMS evaluated treated and transported- Difficulty breathing, tongue swelling, flushing, airway swelling 12:22 patient received covid 19 Pfizer vaccine 12:23 EMS called off to assess patient c/o of difficulty breathing, tongue swelling, flushing. 12:28: 50 mg IV diphenhydramine - some improvement seen- patient transferred to higher level of care per EMS
37 2021-02-04 ringing in ears Tinnitus; headache; This is a spontaneous report from a contactable other Health Professional (patie... Read more
Tinnitus; headache; This is a spontaneous report from a contactable other Health Professional (patient). A 37-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 09Jan2021 10:00 at single dose in right arm for covid-19 immunization. Medical history included chronic pain, hypothyroidism and anxiety, allergies to medications, food, or other products included sulfa.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine, eszopiclone (LUNESTA), ibuprofen (MOTRIN), celecoxib (CELEXA). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No treatment was received. The patient experienced tinnitus and headache on 11Jan2021. The outcome of the events was recovering.
37 2021-02-05 dry mouth, taste disorder The patient felt extremely warm, jittery, her heart was racing, and her face was swelling 10 minutes... Read more
The patient felt extremely warm, jittery, her heart was racing, and her face was swelling 10 minutes after receiving the vaccine. Her face swelled slightly and her arm had shooting pain up and down. The symptoms started with dry mouth and a weird taste in her mouth. That sensation continued for approximately 30 minutes.
37 2021-02-05 vision blurred Patient presented with chills, upset stomach, blurry vision, lightheadedness and the feeling that sh... Read more
Patient presented with chills, upset stomach, blurry vision, lightheadedness and the feeling that she would pass out. These symptoms presented less than 2 minutes after receiving her Pfizer vaccine. Her blood pressure was slightly elevated when EMS evaluated patient. The feeling resolved after 15 minutes and the patient went home.
37 2021-02-07 eye pain On day 16 post-injection, I started experiencing left sided pins/needles/numbness. I went to the ER... Read more
On day 16 post-injection, I started experiencing left sided pins/needles/numbness. I went to the ER and they did a CT and CTA which was normal. The next day or so I went to neurology who ordered blood tests (Lyme's, Vitamin deficiencies, Sjrogen's antigens, CRP, ferritin, Copper, ACE, TSH, Vitamin D , ANA) that were all negative. Next I had a MRI of the head and spine with and without contrast which was normal. The pins and needs have now spread all over my body. I full body neuropathic pain (burning sensation, numbness, tingling, sharp pain like stabbing, left eye pain, feeling like bugs are walking on me, and zapping pain). Neurology is continuing to work up my symptoms but they were new onset after COVID vaccine.
37 2021-02-07 mouth tingling Patient experienced pruritus and lip tingling approximately 20 minutes after injection. Benadryl 50m... Read more
Patient experienced pruritus and lip tingling approximately 20 minutes after injection. Benadryl 50mg IM administered. Patient's symptoms did not worsen and left on her own.
37 2021-02-08 eye discharge Had second dose on Saturday; headache and body aches the rest of Saturday and Sunday. Monday just bo... Read more
Had second dose on Saturday; headache and body aches the rest of Saturday and Sunday. Monday just body aches. Tuesday around 12:30pm during lunch break felt like I had something in my eye. Pulling out white stringy stuff and about 20 mins after initial feeling my eyes were nearly swollen shut, felt like lots of sand in my eyes, and a headache. I do not have any food or seasonal allergies, only allergy to sulfa.
37 2021-02-08 eye pain First day: Fatigue Extreme Restless Leg (Advil calmed) Fever (101.4 at highest, Advil, damp washclot... Read more
First day: Fatigue Extreme Restless Leg (Advil calmed) Fever (101.4 at highest, Advil, damp washcloth on forehead) Chills Muscle ache in hips (hot rice pillow, Advil) Pain at injection site 2nd day: Lower fever (99.7, Advil, no damp wash cloth, seemed too cold) Chills Muscle ache in hips and hands (hot rice pillow, Advil) Fluttering under right breast (about 2 seconds long, happened 6 times) Start of migraine (Aleve, took edge off but not completely gone) Pain at injection site Day 3: Migraine (Aleve) Muscle aches in hands (Advil) Late in day, around 2pm, migraine turns into headache in left eye socket by around 7pm pain feels more like congestion in same area. (Aleve, doesn't seem to help much, neither does Advil) Day 4 (Morning): Headache/congested feeling in left eye socket continues (Aleve or Advil, neither help so far)
37 2021-02-08 eye itchiness ITCHY EYES, FACE, CHEEK, AND HEADACHE 4/10. WAS GIVEN BENADRYL 50MG BY PROVIDER AND MONITORED FOR 45... Read more
ITCHY EYES, FACE, CHEEK, AND HEADACHE 4/10. WAS GIVEN BENADRYL 50MG BY PROVIDER AND MONITORED FOR 45 MIN WITH NO FURTHER SYMPTOMS.
37 2021-02-08 lip swelling, mouth tingling, mouth itchiness 1st dose: 01Jan2021/ 2nd dose: 25Jan2021; Angioedema and systemic anaphylaxis; Angioedema and system... Read more
1st dose: 01Jan2021/ 2nd dose: 25Jan2021; Angioedema and systemic anaphylaxis; Angioedema and systemic anaphylaxis; itchy face; Lips swollen; itchy mouth; tongue tingling; This is a spontaneous report from contactable Pharmacists. A 37-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN5318, Exp Date: 31May2021) intramuscular in right arm on 25Jan2021 15:45 at single dose for COVID-19 immunisation. She received the first dose on 01Jan2021 for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient experienced angioedema and systemic anaphylaxis on 25Jan2021, events resulted in emergency room/department or urgent care. The signs and symptoms of the anaphylactic reaction were described as itchy face and mouth 20-30 minutes after the vaccination, lips swollen, tongue tingling. Patient was scared and crying. Her lips started to swell. The patient require medical intervention, the patient was seen in the emergency department. It was unknown if the patient hospitalized, the patient was not admitted to an Intensive Care Unit. It was unknown it the patient received treatment. The patient did not receive any recent vaccines for SARs-CoV2 other than Pfizer-BioNtech Covid-19 Vaccine prior to the event being reported. Events outcome was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-02-09 mouth numbness Within minute of injection began to have numbness at back of throat and tongue; Within minute of inj... Read more
Within minute of injection began to have numbness at back of throat and tongue; Within minute of injection began to have numbness at back of throat and tongue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL1287; expiration date: unknown), via an unspecified route of administration left arm on 20Jan2021 14:45 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies before vaccination. The patient was not diagnosed with COVID prior vaccination. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and cetirizine hydrochloride (ZYRTEC). The patient did not have other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EH9899) at the age of 37-year-old via an unspecified route of administration left arm on 28Dec2021 11:00 AM at a single dose for covid-19 immunization. The patient received her vaccine Public Health Clinic/Veterans Administration facility. The patient reported that within minute (20Jan2021 02:45 PM) of injection, began to have numbness at back of throat and tongue. No swelling or difficulty breathing was experienced by the patient. The patient received treatment for the adverse events which included diphenhydramine 50mg IM. The patient did not have COVID tested post vaccination. The adverse event required a doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in Jan2021.
37 2021-02-09 lip swelling, swelling of eyelid Within a few minutes had hives, itching, some swelling in lips and eyes. For 48 hours afterwards had... Read more
Within a few minutes had hives, itching, some swelling in lips and eyes. For 48 hours afterwards had low grade temp (100.1), diarrhea, chills, body aches, exhaustion.
37 2021-02-09 pain in jaw Intense back pain, lower back pain above buttocks, similar to contractions all day, joint aches ever... Read more
Intense back pain, lower back pain above buttocks, similar to contractions all day, joint aches everywhere, chills, temp 99.9, no appetite, head pounding, at 15 hours later, back pain continued and wrapped around quads and down to shins and calf?s, aches stopped but stayed strong at jaw. Neck pain stopped the following morning 7am, headache persude lethargy, and weakness rest of day, more appetite but not back to normal, light headed rest of day.
37 2021-02-09 vision blurred Woke up at 1:00 am in a sweat, sore and achy. Had a headache that got worse as the day went on. This... Read more
Woke up at 1:00 am in a sweat, sore and achy. Had a headache that got worse as the day went on. This headache turned into a migraine. I was so sore I couldn?t get out of bed. It got worse throughout the day. I had a fever and chills. At 48 hours my head was still in a fog, eyes wouldn?t focus, dizzy and hurt especially when I coughed or sneezed. Arm, armpit were swollen and sore. At 6o hours my head was better but still sore. I was told not to take medication and the ?ride it out.?
37 2021-02-09 visual impairment, vision blurred I suddenly had blurry vision with dots and squiggles in front of my eyes to the point I couldn't eve... Read more
I suddenly had blurry vision with dots and squiggles in front of my eyes to the point I couldn't even see. It then turned into a raging headache. I went to bed, where I had terrible, restless sleep. I woke up feeling as if I was awake all night and very woozy and weak. It went away by early afternoon the following day, so a total of about 20 hours.
37 2021-02-09 visual impairment Subjective complaints of intense frontal headache with visual changes approximately 10 minutes follo... Read more
Subjective complaints of intense frontal headache with visual changes approximately 10 minutes following her second COVID vaccination. Initial BP was 192/127 HR 96. We continued to monitor her and due excessively high BP's she was transported to ER via ambulance. PO benadryl 50 mg was given.
37 2021-02-10 loss of taste, loss of smell Received my vaccine on 12/23, woke up 12/24 and was really tired as morning went on I got really col... Read more
Received my vaccine on 12/23, woke up 12/24 and was really tired as morning went on I got really cold and could not get warm, throat started to hurt, body aches and had low grade temp of 100.5, 12/25 felt the same but throat was really sore, 12/26 tested positive for Covid, 12/27 lost sense of taste and smell, 12/28 had horrible shortness of breath and burned when I breathed. 12/29 and 12/30--was very tired, body aches and generally did not feel well. 1/1 woke up and felt well, 1/2 had shortness of breath with activity and not feeling well in general. 1/3 had severe shortness of breath and tachycardia at rest--had to report to ER. 1/4-still had shortness of breath and burning while breathing and then had nausea, vomiting and diarrhea throughout the night. 1/5 went to er because I was so nausea and could not keep anything down and was having heart racing and chest pain. received fluids in er and nausea medications. 1/6, 1/7, 1/8 and 1/9 was very weak and still did not feel well, short of breath. 1/10 woke up and had lung burning, chest pain , shortness of breath and heart racing--was seen in ER for chest pain. week of 1/10 was very tired and short of breath. finally returned to work 1/18---still am short of breath, heart races and tire easily
37 2021-02-10 oropharyngeal discomfort, swollen tongue, mouth discomfort she needed to clear her throat a few times; felt dizzy; disoriented; foggy headed; mouth felt full; ... Read more
she needed to clear her throat a few times; felt dizzy; disoriented; foggy headed; mouth felt full; tongue was larger than normal and swollen; This is a spontaneous report from a contactable consumer (patient herself). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 22Jan2021 at 09:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as the clinic. The patient had no medical history; she had no allergies to medications, food, or other products. Concomitant medications included aloe ferox gum, aloe vera gum, atropa belladonna herb, peumus boldus leaf oil, rhamnus frangula (SPARK, "Advocare Spark") and "NLA for Her Shred Her" as diet supplement (sup). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Jan2021 at 10:00, also reported as 10-13 minutes after vaccination, the patient needed to clear her throat a few times. Within seconds or minutes, she felt dizzy, disoriented, and foggy headed. Then her mouth felt full and she looked in the mirror and noticed her tongue was larger than normal and swollen. The reporter assessed the events as non-serious. The adverse events did result in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events, which included a steroid and diphenhydramine (BENADRYL) shot. The patient recovered from all the events on an unspecified date. Information on the batch/lot number has been requested.
37 2021-02-14 blindness The day after vaccination I lost vision for an hour then had onset migraine. Migraines continued and... Read more
The day after vaccination I lost vision for an hour then had onset migraine. Migraines continued and then had sudden onset of vertigo, ataxia, nausea, and vomiting 6 days following vaccine. I could not walk with the ataxia for several days and ended up in ED 8 days after vaccine for persistent vertigo, migraines, and nausea not improved with antivert and imitrex. I do have a history of migraines but I have never experienced this vertigo and migraines lasting days on end. I am now currently 19 days past vaccine and still with vertigo and migraines.
37 2021-02-14 taste impairment Pt has 2nd dose of Pfizer vaccine today at approx 1037 and at within 5 min experienced nausea, palpi... Read more
Pt has 2nd dose of Pfizer vaccine today at approx 1037 and at within 5 min experienced nausea, palpitations and a metallic taste simuliar to copper pennies. She had breakfast at 0900 and had taken oral SL Zofran at 0930 due to previous reaction to the first vaccine where she had nausea, vomiited x 3 metallic taste and had to go home from work. 1055 had vomiting x 2 at present sitting in chair with legs elevated all VSS will list below. 1105 Spoke with Doctor and pt states she wants to go home. He said to offer her a Tryptase test to confirm a diagnosis of anaphylaxis. The Lab was called and the tests results take 5 to 7 days it is sent out to Lab. Informed pt of the offer for testing and the time frame. 1117 Vomited for the third time and VSS are stable in recliner chair. 1125 Doctor informed pt wishes to go and sleep she is now starting to get a headache. She also does not wish to pursue the Tryptase test which she would have to go the urgent care to be seen and ordered. Pt has a co-worker to drive her home and declines to go to Urgent care. She was instructed to return if her symptoms worsen.
37 2021-02-14 mouth numbness Mild Facial and tongue numbness.
37 2021-02-15 mouth tingling Left arm became very sore after about 8 hours after each dose. After the 2nd day after each injectio... Read more
Left arm became very sore after about 8 hours after each dose. After the 2nd day after each injection, a wave of exhaustion hit me. About 10 days after the first injection, I felt a tingling in my lip and a cold sore erupted. Then another! I've never had 2 at the same time. One on the top lip and one on the bottom. I haven't had a cold sore in 15 years. I had my 2nd titer on February 3rd. On February 15th I had another eruption of another cold sore. I didn't think the first recurrence of a cold sore was linked to the vaccine, but the timing of the 2nd one is beyond coincidental, which is why I'm reporting it. Abreva is not helping too much. I haven't had a herpes breakout since 2006.
37 2021-02-17 ear pain Fever 101.3 (reduced w/ Tylenol), severe generalized body aches, severe injection site muscle pain, ... Read more
Fever 101.3 (reduced w/ Tylenol), severe generalized body aches, severe injection site muscle pain, nausea (no vomiting), headache, severe chills, ear pain, restlessness, short interval of mild shortness of breath. All severe symptoms resolved by 30 hours after vaccine administration.
37 2021-02-17 mouth numbness, mouth tingling About 5-10 min later I started getting tingling sensation on my lips and tongue. After 15, my lips g... Read more
About 5-10 min later I started getting tingling sensation on my lips and tongue. After 15, my lips got numb, along with my jaw. The numbness was only on my left side and went from my jaw to my eye. I also had a headache as well. I also felt like something was stuck in my throat, but not like I couldn't get air. Those symptoms lasted about 2-3 hours. When I got home, about an hour after I got the vaccine, I ended up breaking out on torso. I took Benadryl and went to sleep. The next morning, I was itchy and breaking out in hives in torso area. I took Benadryl again and the numbness and itchiness improved, but I had a headache for like 8 days. On the 6th day, I had really bad body aches and my headache was extreme. Per on call allergist, I wasn't allowed to get 2nd dose based on CDC guidelines.
37 2021-02-19 dry mouth Dry mouth 15 minutes after injection. BP 150/77 (pulse 89); O2 sat 100%. Albuterol 2 puffs given.
37 2021-02-19 taste impairment 1 hour after vaccine given patient started to have salty taste in her mouth and salty taste to food ... Read more
1 hour after vaccine given patient started to have salty taste in her mouth and salty taste to food and drink 2 days after vaccine noted not able to hold water in her mouth and noted right facial weakness. Progressed over the next 3 days to complete right facial paralysis ( OV 1/19/2021) Follow up on 2/9/2021- some improvement of facial paralysis -- approximately 50-75%
37 2021-02-22 vision blurred Patient reported at 6:40 pm that she had thrown up and was having nausea. EMS attendant was on stan... Read more
Patient reported at 6:40 pm that she had thrown up and was having nausea. EMS attendant was on standby and took vitals: 129/89 BP, Resp 16, lungs clear on auscultation, pulse 104, blood sugar 69. Patient reported she had not eaten since 12:00 pm. Patient reported at 6:50 pm that her nausea was improving. At 7:00 pm, patient had a near-syncope event and was diaphoretic. She was placed in a wheelchair and taken to a private area. She appeared struggling to focus, but was responsive to questions. She developed a rash on her chest and an ambulance was called related to dermal, CNS, and GI symptoms. On ambulance arrival, Diphenydramine 15 mg IV was given and patient was transported to ER.
37 2021-02-26 eye swelling I first had a typical reaction to the vaccine, including soreness at site, fatigue, aches, and chill... Read more
I first had a typical reaction to the vaccine, including soreness at site, fatigue, aches, and chills. On the fourth day after the shot, I developed shingles on my left side (the same side as where I received the vaccine). It began on the left side of my scalp and progressed down my forehead and to my left eye. My left eye also became very swollen, to the point of being shut. I am 12 days post vaccine now, and I still have shingles and my eye is still very swollen. I have been seen at both the ER and urgent care. I am currently taking Valtrex, oral steroids, and have antibiotic ointment for my eye as well as steroid eye drops.
37 2021-02-26 gaze palsy Fever (100 degrees), chills, worsening of headache, shooting pains in joints and back of neck, muscl... Read more
Fever (100 degrees), chills, worsening of headache, shooting pains in joints and back of neck, muscle soreness. I took Tylenol, max strength, and Aleve to help with symptoms. Fever and chills lasted most of the night (~7hours), pain, headache and soreness of muscles lasted 14 hours. Joints remained stiff and painful to use the rest of the following day.
37 2021-02-28 loss of taste 2nd dose: Fever; extreme chills; all over muscle aches; loss of taste; extreme fatigue; upset stomac... Read more
2nd dose: Fever; extreme chills; all over muscle aches; loss of taste; extreme fatigue; upset stomach; dehydrated; weakness; loss of appetite; chest tightness; feel like a panic attack; This is a spontaneous report from a contactable Other Healthcare Professional, the patient. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), intramuscularly on 19Jan2021 at 11:00 (at the age of 37-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was not provided. The patient has no allergies to medications, food, or other products. Historical vaccinations include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686) on 30Dec2020 at 19:00 intramuscularly as a single dose in the right arm for COVID-19 vaccination after which the patient experienced fatigue, muscle soreness in neck and shoulders and vaccination site pain. The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MIDOL) and ibuprofen(MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 19Jan2021 at 23:30 she began to experience fever, extreme chills, all over muscle aches, loss of taste for a day ,extreme fatigue, upset stomach, dehydrated, weakness, loss of appetite, chest tightness that would come and go making it feel almost feel like a panic attack. She further stated that she has lingering side effects such as extreme fatigue, muscle aches and chest tightness after day three of receiving this second dose that comes and goes. Currently on day seven and still have those lingering three side effects. Fatigue has been extreme at times. The patient did not receive any treatment for the events. The clinical outcomes of the events Fever, extreme chills, myalgia, loss of taste, extreme fatigue, upset stomach, dehydration, weakness, loss of appetite, chest tightness and panic attack were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107223 Same reporter, Same product, Same patient, same and different events (First Dose)
37 2021-02-28 mouth numbness, mouth swelling, mouth tingling Client vaccinated during drive-through event, in a remote, rural setting approx 40 minutes from near... Read more
Client vaccinated during drive-through event, in a remote, rural setting approx 40 minutes from nearest hospital, and instructed to wait 30 min due to past h/o anaphylaxis. At 20 min post-vaccine, she reported feeling "funny," with swelling, tightness, and numbness in her face and inside of her mouth, although "not as bad as last time." Noted to be tachy in the 130's, and making constant mouth movements due to the increasing numbness. After brief explanation, adult Epipen admin to rt thigh. O2 sat remained in upper 90's throughout, and no resp distress was ever noted. BP fluctuated between 96/60 and 142-92 during the course of management. 50mg IM diphenhydramine followed the Epipen, as ambulance was enroute, unknown ETA. With constant monitoring, client reported chest tightness and variable feeing of swelling, tightness, and numbness inside her mouth and face/chin. After 20 min, with some improvement of symptoms, transported by ambulance to ED, where she received continued monitoring and steroid admin. According to ER note, she was released to home after some hours of observation.
37 2021-02-28 eye discomfort, dry eye 2/19/21 patient notice lump under Lt arm (painful), which resolved in 1 week. On 2/25/21 she felt ti... Read more
2/19/21 patient notice lump under Lt arm (painful), which resolved in 1 week. On 2/25/21 she felt tightness and pressure on Lt side of the neck and behind Lt ear which was progressing to numbness. On 2/28/21 she noticed LT facial droop and consulted her MD, who diagnosed her with Bell's Palsy and informed her that could be a side effect from Covid 19 vaccine.patient says that her Lt side of face is still numb and she cannot close her Lt eye, which causes dryness and discomfort. She was started on antiviral medication and steroids by mouth.
37 2021-02-28 mouth tingling tongue and lip tingling; subjective swelling; This is a spontaneous report from a contactable physic... Read more
tongue and lip tingling; subjective swelling; This is a spontaneous report from a contactable physician reported that a 37-years-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on 27Jan2021 at single dose for covid-19 immunisation. Medical history included anaphylaxis; nightshade vegetable allergy; Food allergy, migraine, Attention deficit hyperactivity disorder, anxiety, former smoker. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), alprazolam (XANAX), escitalopram oxalate (LEXAPRO), ethinylestradiol, norethisterone acetate (JUNEL), amitriptyline (AMITRIPTYLINE). The patient previously took atropine had anaphylaxis and known allergies. On 27Jan2021, patient developed tongue and lip tingling and subjective swelling within 10 minutes after vaccine administration. No angioedema. The patient was received treatment with benadryl, pepcid, IVF and solumedrol. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, was the patient was not diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. The outcome of the events was recovered in 2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events "tongue and lip tingling and subjective swelling" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-03-01 ear pain Feb 22 started to get some pimples in the left ear Feb 26 started to get some pain in left ear Feb... Read more
Feb 22 started to get some pimples in the left ear Feb 26 started to get some pain in left ear Feb 27 diagnosed as shingles at NYU urgent care .
37 2021-03-01 swollen tongue, eye swelling, lip swelling On 2/17 woke up with 102.3 fever, tongue, lips, eyes swollen, inside mouth/throat irritated, injecti... Read more
On 2/17 woke up with 102.3 fever, tongue, lips, eyes swollen, inside mouth/throat irritated, injection site red and swollen, tingling down left arm extreme fatigue. Increased Blood Pressure and Heart rate
37 2021-03-03 lip swelling, swollen tongue 30 minutes after shot my throat and tongue started to swell. I took benadryl at that time. 8 hours l... Read more
30 minutes after shot my throat and tongue started to swell. I took benadryl at that time. 8 hours later I became very itchy and my face swelled (including lips)
37 2021-03-03 oropharyngeal discomfort arm automatically felt heavy and hot. immediately started coughing. then after that I started feelin... Read more
arm automatically felt heavy and hot. immediately started coughing. then after that I started feeling tight in my chest and airways. I waited and it progressively got worse. it felt like I had phlegm stuck in my throat that I could not get out. nurses at the drive offered to call 911 but I was close enough to an Urgent care/ER that I decided to drive myself over there. they took me in, started an IV and gave me 50mg of epinephrine and Benadryl, steroids and Pepcid. they prescribed an EpiPen. They told me to continue taking Benadryl because the allergic reaction could resurface. cough is still present and I have body aches.
37 2021-03-03 oropharyngeal discomfort PT STATED SHE IS NORMALLY FATIGUED AND LETHARGIC AFTER VACCINES. NORMALLY TAKES BENADRYL AFTER VACCI... Read more
PT STATED SHE IS NORMALLY FATIGUED AND LETHARGIC AFTER VACCINES. NORMALLY TAKES BENADRYL AFTER VACCINES. PT WAS ADMINISTERED VACCINE AND WAS IN OUR OBSERVATION AREA AND STARTED COMPLAINING OF CHEST TIGHTNESS, CLAMMY HANDS AND LIGHTHEADEDNESS. PROVIDER APPROACHED PATIENT AND PT COMPLAINED OF SOME THROAT TICKLING BUT NO BREATHING ISSUES. EMS ASSIST WAS CALLED. WHEN EMS ARRIVED TO THE PT, SHE VOMITED. EMS TRANSPORTED PT TO ER.
37 2021-03-03 mouth tingling, lip swelling First sign - tingling in upper lip, similar to that of the beginning of a cold sore After 1 hour - l... Read more
First sign - tingling in upper lip, similar to that of the beginning of a cold sore After 1 hour - lip begins to swell Went to Express Care clinic 6:30pm, nearly 8 hours after shot. Prescribed prednisone to reduce swelling. 7pm - took first dose of prednisone. Lip continued to swell Upper lip continues to swell to a severe level throughout evening and night Overnight, swelling expanded to cheeks . Cheek swelling moderate, lip swelling still severe 7am - took half of 2nd dose of prednisone and applied cool compact Throughout 3/4/2021, lip swelling reducing, cheeks still swollen similar to mumps
37 2021-03-03 mouth tingling Throat swelling, tongue tingling, voice change
37 2021-03-04 oropharyngeal discomfort Chest tightness/pain, acid reflux, gas, throat discomfort, fever, injection site soreness, headache,... Read more
Chest tightness/pain, acid reflux, gas, throat discomfort, fever, injection site soreness, headache, fatigue, extreme nausea, and body aches.
37 2021-03-04 mouth tingling, lip swelling Swelling/hives on left arm, left hand, and right hand. Tingling/swelling lips and lump in throat.
37 2021-03-04 mouth tingling 3:08pm 37yo active duty female presents with a change of voice and swelling of the throat and tingli... Read more
3:08pm 37yo active duty female presents with a change of voice and swelling of the throat and tingling tongue. Patient denied any difficulty breathing and was able to swallow and control secretions. Patient has had an anaphylactic reaction with pork and beef in the past. Patient states she is on numerous amounts of medication. Epinephrine was delivered via IM on right thigh at approximately 3:08pm. EMS was called at 3:10pm and arrived at 3:13pm. At 3:11pm, patient reported tongue was no longer tingly but still numb. SPO2 98%, HR110, BP 148/100. Patient was released upon stabilization.
37 2021-03-04 taste disorder stools have been weird looking and smelly, like yeast; stools have been weird looking and smelly, li... Read more
stools have been weird looking and smelly, like yeast; stools have been weird looking and smelly, like yeast; coffee (which is what has been tasting weird), tasted so gross; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 37-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3302, Expiry date: unknown), at 37 years of age via an unspecified route of administration on Left arm on 01Feb2021 at single dose for COVID-19 immunisation. Medical history was none. Concomitant medication included multivitamin (unspecified) and estradiol (ESTROGEN) as a supplement within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (Lot number: EJ1685, Expiry date: unknown) on 07Jan2021 at 09:30 AM on left arm for COVID-19 immunisation and experienced Exactly two weeks after the first vaccine I started smelling cigarette smoke and a sweet garlicky smell. Things tasted a little funny, but I mostly noticed it with coffee. Patient also had known allergies to clindamycin and Sulfa. The patient stated that, things tasted a little funny, but I mostly noticed it with coffee. I didn't think about the COVID shot, I just thought maybe I had a cold. Then exactly two weeks after the second, my coffee (which is what has been tasting weird), tasted so gross I had to throw it out in Feb2021. That's when I put it all together that it is probably from the vaccine. Then the more I research that sweet garlic is actually yeast I am smelling. Then I realized since all this has started by in Feb2021 stools have been weird looking and smelly, like yeast and sure enough I googled it and it looks similar. My co-worker is having a yeast infection also, but it is only in her mouth. The patient received treatment for the events with diflucan 150mg a 20-week cycle. The reporter considered the events as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed as non-serious by the reporter. The outcome of the events was reported as not recovered.; Sender's Comments: Based on temporal relationship, the causality between the suspect 'BNT162B2' and the reported 'stools have been weird looking and smelly, like yeast' cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
37 2021-03-05 mouth numbness Numbness to right side of cheek/lip Rash to bilateral hands/arms/abdomen/legs/back/chest Arm injecti... Read more
Numbness to right side of cheek/lip Rash to bilateral hands/arms/abdomen/legs/back/chest Arm injection pain. Mottling to skin all over Warmth radiating up my arm to my face where it?s numb Body aches
37 2021-03-05 lip swelling Flushing, swelling of upper left lip. Itchiness on face, brain fog. BP 150/105 (pulse 119). Final BP... Read more
Flushing, swelling of upper left lip. Itchiness on face, brain fog. BP 150/105 (pulse 119). Final BP 129/97 (pulse 93).
37 2021-03-06 vision blurred COMPLAIMED OF FEELING HOT, STOMACH UPSET, BLURRY VISION, LIGHT HEADED, VS BP - 97/72 HR 81, OBSERVED... Read more
COMPLAIMED OF FEELING HOT, STOMACH UPSET, BLURRY VISION, LIGHT HEADED, VS BP - 97/72 HR 81, OBSERVED 30 MINS, OFFERED WATER AND PATIENT CONSUMING, BP RECHECKED POST 30 MINS NOW 118/72. PATIENT STATES FEELING BETTER, AND NEEDS TO EAT.
37 2021-03-07 feeling of choking Felt tingling in RUE (resolved), followed by throat tingling. Patient self-medicated with Benadryl 2... Read more
Felt tingling in RUE (resolved), followed by throat tingling. Patient self-medicated with Benadryl 25 mg PO. Felt throat tightening - consulted with provider, who gave Benadryl 50 mg IM. Vitals within normal limits. Resolved.
37 2021-03-09 eye swelling woke up with eye swelling. Now with jaw and chin numbness
37 2021-03-09 mouth tingling Patient experienced sweating, dizziness and tingling on the mouth. She was sweating profusely and fe... Read more
Patient experienced sweating, dizziness and tingling on the mouth. She was sweating profusely and feeling hot. Pharmacist gave her Benadryl and after 20 minutes , she said she felt better . Observed the patient for few more minutes until she was okey. Patient advised to call primary care doctor if anymore reaction.
37 2021-03-09 feeling of choking At 9:43 am client states she has tingling sensation in back of her throat. Client advised to drink w... Read more
At 9:43 am client states she has tingling sensation in back of her throat. Client advised to drink water. 9:45 am an MD onsite at the clinic is requested to assess. Client did not complain of any flushing, or difficulty breathing. She states she has her own Benadryl was advised not to take it because she was going to drive home. Client was reassessed at 10:08 and 10:14 am states feels better and can drive. Client was on observation for 30 minutes before released to go to home.
37 2021-03-10 taste impairment Ever since the first dose, I have had a strong metallic taste in my throat/mouth and my upper teeth ... Read more
Ever since the first dose, I have had a strong metallic taste in my throat/mouth and my upper teeth are starting to gray in the back. No other variables other than the vaccine. Have seen some data that others experience a metallic taste and that Covid can cause teeth Green, so thought I would report. I have never had a positive Covid test or any reason to believe I have had Covid. Just the vaccine
37 2021-03-10 mouth tingling Aprox 3 min after injection, broke out in rash and hives, severe itching in neck, face, chest, tingl... Read more
Aprox 3 min after injection, broke out in rash and hives, severe itching in neck, face, chest, tingling lips and shaking. EMS was on scene at clinic immediately removed me from car and checked vitals, BP was high 176/94, took by ambulance to ER at Medical Center. Treated in ER for 4.5 hours. Developed migraine, received benadryl, steriods,and medicine for the migraine. Sent home told take benadryl for 2 days and do
37 2021-03-10 thirst 2 hours after injection got extremely tired and had rashes similar to that of a scalding water burn ... Read more
2 hours after injection got extremely tired and had rashes similar to that of a scalding water burn on the tops my feet. They are circular in shape and the skin between my toes hurt. The rash covers the majority of the tops of my feet. They are itchy. I have almost slept since 8pm last night and it is now 3:15 the following afternoon. My husband had difficulty waking me up. I have been extremely foggy and jumbleing my words each time I wake up and when I try to text I dont realize I'm typing words that do not make sense. I also have the normal symptoms like headache and sore arm. Tops of my hands seem puffy and red. Extreme thirst and hunger.
37 2021-03-11 eye pain Immediately after injection I felt a tingling in my back that went away within 25 minutes. My left a... Read more
Immediately after injection I felt a tingling in my back that went away within 25 minutes. My left arm started tingling/feeling numb in small areas starting days after injection from vaccine site up to my neck. Days later it spread down to my left hand. It has now been over a month straight of my entire left arm and left hand tingling/feeling numb, with my hand and fingertips being the worst. The symptoms affect me all day every. I?ve also had very bad headaches with the pain behind my eyes multiple times a week since the injection.
37 2021-03-11 light flashes or floaters in the eye After 60 minutes from receiving the first shot my face became flush and hot like a bad sunburn. Thi... Read more
After 60 minutes from receiving the first shot my face became flush and hot like a bad sunburn. This only showed on my cheeks and a little on my forehead in color and felt hot to touch. The rest of my face being warm but not with the red coloring. The flush coloring faded after 4 hours and my face felt less hot but still warm. I didn't take anything but water and some food. A bad headache was included in this feeling and now my face feels and looks closer to normal after 9 hours. I did not run any fever and I did feel that laying down was the only thing to do. Yet while resting, lights flashed from my right side to the center (when looking into the darkness) which was very new and different. I only mention this as I have no clue how that could be related but I've never experienced this...
37 2021-03-11 swollen tongue Patient began feeling tongue swelling, tightness in throat, progressed to headache, flushing, chest ... Read more
Patient began feeling tongue swelling, tightness in throat, progressed to headache, flushing, chest tightness. Patient refused 911-EMS. Ambulated to ER, escorted by RN.
37 2021-03-12 taste impairment Metallic taste in mouth after 10 minutes of receiving injection. Left arm axillary lymph node swell... Read more
Metallic taste in mouth after 10 minutes of receiving injection. Left arm axillary lymph node swelling that began the day after vaccination. The swelling persist, it is day 4 today.
37 2021-03-13 taste impairment Strong persistent metallic taste in mouth
37 2021-03-14 swollen tongue difficulty swallowing, tongue feels swollen, evaluated by EMS, refusal to transport
37 2021-03-14 thirst Severe and sporadic itching of entire body 3 days post vaccine which has continued for over a week n... Read more
Severe and sporadic itching of entire body 3 days post vaccine which has continued for over a week now (8 days to be exact). Small rash will sometimes appear however after a few hours will go away. Benadryl will sometimes help however the itching is not getting better on its own. Predominately located on all 4 limbs, neck and chest. Itching is worse towards end of the day, especially at night and for short durations throughout remainder of the day. Itching to the point of breaking skin to relieve and even then it continues. I have increased water intake and have to take benadryl at night to even get some rest however once the benadryl wears off it comes back and almost worse.
37 2021-03-14 vision blurred, mouth numbness Tongue, lips, face went numb at around the 5 min mark. Then hands and arms. I was dizzy and weak, ha... Read more
Tongue, lips, face went numb at around the 5 min mark. Then hands and arms. I was dizzy and weak, had a hard time walking. I noticed my vision was blurred. I couldn't see freckles on my arms that I usually can see. After 40 mins the numbness improved. On the drive home I was swept with head-to-toe numbness for about a min with the feeling like I was going to throw up and chest pain. The chest pain continued to come and go a few times for the next 10-12 hours. I was very dizzy and very weak. My vision went back to normal about 5 hours later. But I remained dizzy and weak for about a week. I still have dizziness on and off throughout the day that I never had before though. All those symptoms I feel like are outside of what was expected and concern me but other than that I had symptoms that I expected as well like my arms was sore for maybe 3 hours total the day after, I was tired, and had an elevated temp around 100 degrees.
37 2021-03-15 eye movement disorder Scenario: Pharmacist administered immunization and patient had immediate reaction to imz. The patie... Read more
Scenario: Pharmacist administered immunization and patient had immediate reaction to imz. The patient has multiple health conditions such as lupus, cerebral palsy, and is currently on dialysis. She indicated on the PQCF that she had never had an adverse reaction after a vaccine but after the incident, her husband indicated this was normal and not uncommon. SIG: Pharmacist Administered Immunization What happened (Describe in detail, what occurred)? * The patient came in for a covid vaccine; this was the first of a 2 series of Pfizer. * The pharmacist injected the immunization and a few minutes afterwards the husband called for the pharmacist to come because his wife didn't feel well. She immediately became unresponsive and her eyes rolled back into her head but she came to. She was responding somewhat to questions but she was also slightly mentally impaired at baseline due to her co-morbidities. She never fell to the ground or wanted to lie down, so not a true faint. * The pharmacist offered to call 911 but they both declined. The patient was given water and a banana and taken to a private area to recover until she fell well enough to leave. How did it happen? * The Pharmacist administered an appropriate, routine vaccine per protocol. *Patient had an somewhat immediate reaction (~4 minutes) after the vaccine. *The pharmacist followed the adverse event protocol. CPR was not administered nor benadryl. Why did it happen (Root Causes)? * Unknown; patient has no known allergy to the vaccine but has had adverse reactions to different procedures in the past. Plan of Action * Make sure all pharmacists are refreshed and aware of the adverse reaction protocol. *Document reaction as a SCRT and with VAERS. What specific task will take place to prevent future recurrence? *N/A. Who: * Pharmacist Where: * clinic When: *All pharmacists at location must review by 3/20.
37 2021-03-15 lip swelling Two hours you noticed swelling but I didn't think much of it. I started feeling a little weird and p... Read more
Two hours you noticed swelling but I didn't think much of it. I started feeling a little weird and pain in the arm. About 01:00, I woke up and I was in a lot of pain. I had hives all over me. Hives were spreading all over my body: hair; arm with the injection; we called 9-1-1 I went to the hospital. They gave me some meds through IV. By that time, I had taken Bendryl and I was there about 4 hours with IV. I felt better but hives didn't subside. That Sunday afternoon they started getting worse again and I went back to the hospital (16th)and they gave me rounds of something through IV. On 17th, I went back to hospital - they gave me another shot for the hives. I worked on the 18th - but was they said I should go home because I didn't look well. My lip started swelling that night. On the 19th, I went to my doctor and the Dr, used an epi-pen on me and gave me a shot of something for the welts still on my body. They still didn't go away. Symptoms have calmed down - but I still have spots on me. I am on Prilosec and anti-itch - Atarax and some others.
37 2021-03-15 swelling of eyelid, ear swelling Swelling, intense itching and redness on face particularly around eyes and eyelids, cheeks, neck and... Read more
Swelling, intense itching and redness on face particularly around eyes and eyelids, cheeks, neck and back of ears. Also present in and around the bellybutton and on both arms (strong on right arm). Started day after injection and continued to intensify despite doses of benedryl and loratadine, and topical cortisone. Morning of 3/16 woke up to slight swelling in throat and overall intensified swelling in face and neck.
37 2021-03-16 dry throat, dry mouth On Wednesday, March 17, 2021 client received her first dose of Pfizer COVID vaccine (LOT # ER2613, E... Read more
On Wednesday, March 17, 2021 client received her first dose of Pfizer COVID vaccine (LOT # ER2613, EXP 7/2021) at approximately 2:55pm. Client waited in Observation Area and was observed by EMT to have blotchiness in both hands 15 minutes later. Client also stated to EMT her "throat feels tight and dry." EMT alerted Lead RN while EMT took vitals at 3:25pm. Vitals: BP: 110/80, HR: 125 bpm, O2 sat: 96%. Upon assessment of client, Lead RN authorized EMT to administer 50mg of Diphenhydramine HCL oral solution per protocol with a water bottle at 3:36pm. Another set of vitals were taken following administration of Diphenhydramine HCL oral solution. Vitals at 3:38pm: HR: 78 bpm, O2 sat: 97%. Final set of vitals were taken at 3:46pm: BP: 118/86, HR: 71 bpm, O2 sat: 96%. Client stated the initial throat tightness with dry throat and mouth subsided after administration of Diphenhydramine HCL oral solution. At 3:50pm client was educated by Lead RN & EMTs on s/sx of adverse reaction and when to go to the ED/call MD. Client left vaccine site with a steady gait at approximately 3:52pm.
37 2021-03-16 vision blurred Dizziness, numbness in left arm, heart palpitations, nausea, blurred vision. Began within the hour o... Read more
Dizziness, numbness in left arm, heart palpitations, nausea, blurred vision. Began within the hour of the dose. Dizziness, arm numbness, blurred vision lasted less than 24 hours. Heart palpitations lasted 3 days. Breastfed twins also fussy, irritable, trouble sleeping, smaller appetites for three days.
37 2021-03-17 loss of smell, loss of taste Loss of taste; Loss of smell; she tested positive- 5/tested positive for COVID-19; This is a spontan... Read more
Loss of taste; Loss of smell; she tested positive- 5/tested positive for COVID-19; This is a spontaneous report from a sponsored Program. A contactable female consumer (patient) reported that a 37-years-old female patient received bnt162b2 (BNT162B2; Batch/lot number: EL1284) first dose, intramuscular on 11Jan2021 between 9-9:30 a.m at SINGLE DOSE at Right upper arm for covid-19 immunisation. The patient medical history was not reported. Prior Vaccinations (within 4 weeks) was None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. The patient's concomitant medications were not reported. The patient experienced she tested positive- 5/tested positive for covid-19 on 18Jan2021 with outcome of unknown, loss of taste on 18Jan2021 02:00 with outcome of recovered on 23Jan2021, loss of smell on 18Jan2021 02:00 with outcome of recovered 23Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test (COVID-19 Rapid Test): positive on 18Jan2021, sars-cov-2 test (COVID-19 Test): inconclusive on 29Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Caller was scheduled today for the 2nd dose of Pfizer vaccine. However, 2 weeks ago she tested positive- 5 days after the 1st dose of the vaccine. Today, she had no symptoms for over a week and she didn't know yet if she was still positive for COVID or not. Caller was asking if she can take the 2nd dose today or if she needed to wait for days/weeks before taking it. On 11Jan2021, the caller received her first dose of COVID-19. On 18Jan2021, the caller tested positive for COVID-19. She was symptom free after 5 days. She was scheduled to receive her second dose at 12:00pm today. She stated she has been getting conflicting information. She wanted to know can she receive the second vaccine? Since 23Jan2021, she has been symptom free. She mentioned she filled out a questionnaire online about and she did respond that she tested positive after receiving the first dose, but she never heard anything back. Caller stated she noticed probably around 2 am in the morning on 18Jan, she had that feeling in my throat where she was losing her sense of smell and taste. She woke up that morning around 8am, and these senses were completely gone. Caller stated it was the only symptom she had. She confirmed she had a COVID-19 Rapid test done on 18Jan2021. She actually went and got tested again on Friday, 29Jan2021, to see if she still had COVID. However, the person doing the test must not have done it right. The person only swabbed one nostril and the test came back inconclusive as of yesterday. The events not require a visit to Emergency Room and Physician Office. No further information was provided or obtained.
37 2021-03-17 thirst, mouth tingling *Pressure in the head *Pulling and warmth in the face *Tingling in the tongue, feet and fingers: Gab... Read more
*Pressure in the head *Pulling and warmth in the face *Tingling in the tongue, feet and fingers: Gabapentin *Extreme exhaustion and sleepiness *Body ache: Tylenol *Headache- Tylenol *Extreme thirst *Nausea: Ondansetron *Vomiting *Constipation: Senna with Docusate Sodium *Weakness *Some difficulty breathing
37 2021-03-18 eye disorder, eye movement disorder rapid eye movement, dizziness, hard time focusing, feeling of anxiety and panic attacks, hard time b... Read more
rapid eye movement, dizziness, hard time focusing, feeling of anxiety and panic attacks, hard time breathing, head fog. Eye movements started the evening of vaccination... other symptoms followed and are still lingering today, March 19th.
37 2021-03-18 mouth numbness Itching, numb tongue and throat within hour after vaccine. Diarrhea within two hours. Rash on cheeks... Read more
Itching, numb tongue and throat within hour after vaccine. Diarrhea within two hours. Rash on cheeks three days later.
37 2021-03-18 swollen tongue Tongue swelling, dizziness, brain fog, fainting. Lasted 3 hours.
37 2021-03-21 eye swelling, eye pain On the second day I started to feel some mild pain in my left eye. By Monday my eye was swollen and ... Read more
On the second day I started to feel some mild pain in my left eye. By Monday my eye was swollen and painful.
37 2021-03-21 mouth tingling First Pfizer vaccination shot given at 11am, felt fine until 9pm that night then sudden onset dizzy,... Read more
First Pfizer vaccination shot given at 11am, felt fine until 9pm that night then sudden onset dizzy, lips tingling, then cheeks swelled and got very red, low grade fever 99.7F. Took 50mg benadryl within 10 mins of initial symptoms and another 25mg an hour later after talking to the oncall doctor.
37 2021-03-21 swollen tongue Tongue swelling not occluding airway; Fevers of 102-103F; Chills; Sweats; Fatigue; This is a spontan... Read more
Tongue swelling not occluding airway; Fevers of 102-103F; Chills; Sweats; Fatigue; This is a spontaneous report from a contactable nurse (patient). This non-pregnant 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the left arm on 13Feb2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included postpartum 9 months c-section from an unknown date and unknown if ongoing. The patient had no allergies to medications, foods or other products and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included sunflower lecithin, fish oil and postnatal vitamin, all from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number EL9261) in the left arm on 23Jan2021 at 12:00 (at the age of 37-years-old) for COVID-19 immunisation. The patient reported that she experienced tongue swelling not occluding her airway starting 6 hours post second injection on 13Feb2021. She took diphenhydramine hydrochloride (BENADRYL) 25 mg and famotidine (PEPCID) 20 mg orally which resolved the symptoms after 1 hour. She also reported fevers of 102-103Fahrenheit (F) with chills, sweats, and fatigue for 36 hours. The events were reported as non-serious and did not require hospitalization. The clinical outcome of tongue swelling not occluding airway was recovered on 13Feb2021 at 17:00; the clinical outcomes of fevers of 102-103F, chills, sweats and fatigue were recovered on 15-FEB-2021 at 04:00. It was also reported the patient had not been tested for COVID-19 since vaccination.
37 2021-03-22 loss of taste Dizziness; Chills; Everything I eat and drink tastes like chemicals/I tried other peoples food items... Read more
Dizziness; Chills; Everything I eat and drink tastes like chemicals/I tried other peoples food items as well they all tasted, off; This is a spontaneous report from a contactable Other HCP. A 37-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration single dose left arm on 10Feb2021 07:30 for covid-19 immunisation. The patient received the first dose (Lot # EL3249) left arm on 20Jan2021 07:30 AM. Medical history included type 2 diabetes mellitus. Concomitant medication included metformin, insulin glargine (LANTUS). The patient experienced dizziness on 10Feb2021 20:00, chills on 10Feb2021 20:00, everything I eat and drink tastes like chemicals/i tried other people food items as well they all tasted, off (ageusia) on 10Feb2021 20:00. The events outcome was not recovered.
37 2021-03-22 inability to speak, photosensitivity reaction Hives, fever, chills, body aches, migraines, vertigo, photosensitivity, phonophobia, nausea, fatigue... Read more
Hives, fever, chills, body aches, migraines, vertigo, photosensitivity, phonophobia, nausea, fatigue, dizzy light-headed, loss of voice, sob, diarrhea, and sore arm. No outcome still ongoing testing and seeing specialists.
37 2021-03-22 ear discomfort Patient developed cold symptoms on 3/12/21. The symptoms included runny nose, clogged ears, congest... Read more
Patient developed cold symptoms on 3/12/21. The symptoms included runny nose, clogged ears, congestion, and headache. The symptoms resolved on 3/17/21.
37 2021-03-22 mouth tingling 1:45 driving home, started to notice weird feeling like I had an allergy shot. 2:30 I got home and b... Read more
1:45 driving home, started to notice weird feeling like I had an allergy shot. 2:30 I got home and breathing was aggravated. 2 puffs of inhaler, sat down and waited. Breathing worse, 2 more puffs. Breathing not improving enough, tongue started to feel weird. Went to ER. 3:45 went to ER. By 4:45 I was in a room, saw physician at 5:45. I had a heart rate in 140s in triage, and a low BP around 90/60. My tongue continued to feel funny and started to get hard to talk. It felt heavy, but medical staff didn't think swollen. I was given a breathing treatment, Benadryl, Pepcid, IV fluids and monitored. 8:15 I was asked to walk a bit to make sure oxygen was staying up. My chest tightness was getting worse but since my oxygen stayed at 95 when walking, was discharged. As of today, I still struggle to control my breathing and have an appointment with my allergist for tomorrow. I'm scheduling albuterol treatments every 4 hours around the clock and continue to take Pepcid and Benadryl in addition to my normal meds. 3/20 I developed uterine cramping, felt like I was having back labor as the result. Uterine cramping resolved 3/21 but severe soreness in back remained.
37 2021-03-23 taste impairment Nausea, Metallic taste in mouth, headache, entire arm in pain for 24 hours. I was better by the fol... Read more
Nausea, Metallic taste in mouth, headache, entire arm in pain for 24 hours. I was better by the following day 3/20.
37 2021-03-23 mouth tingling Left hand, arm, face, lip were tingly. Slightly dizzy when symptoms began. Tingly feeling has lasted... Read more
Left hand, arm, face, lip were tingly. Slightly dizzy when symptoms began. Tingly feeling has lasted almost 24 hours to varying degrees but has not fully gone away yet.
37 2021-03-23 feeling of choking About 30 minutes after my injection, I started to feel a tingly feeling in my throat, then felt like... Read more
About 30 minutes after my injection, I started to feel a tingly feeling in my throat, then felt like my throat was slightly tightening. I was driving and pulled over to monitor. It stayed the same for about 10 minutes, then started resolving. I never had any trouble breathing and I could sip water. When I returned home, my husband commented that I looked ?flushed.? I called my PCP who recommended to monitor myself, but that I was probably fine and no need for any treatment. I have not had any issues since and now am 24 hours post injection. There is no phone number to the site in which I received my vaccine. I have been trying to connect with someone who can advise on whether it is safe for me to receive my second dose. I would be so grateful for any advice on how to proceed as I really want to get the second shot, but also am concerned if there is a risk that I could have a severe allergic reaction upon receiving it. I have searched the agency website and see where a second dose is not recommended for anyone that has had a severe or non-severe allergic reaction to the first dose. What I had was not severe, but I am unclear if it was enough to preclude me from receiving a second dose. I would so appreciate any insight, guidance, or connection to someone who can advise on how to proceed. Thank you.
37 2021-03-23 ringing in ears Developed lightheadedness, nausea (no vomiting, b/ tinnitus, and tingling in b/l hands. All symptoms... Read more
Developed lightheadedness, nausea (no vomiting, b/ tinnitus, and tingling in b/l hands. All symptoms resolved by 20 minutes of monitoring. Vitals WNL.
37 2021-03-24 ear congestion Vertigo presented one week post-vaccination (1st shot), accompanied by aural fullness in right ear a... Read more
Vertigo presented one week post-vaccination (1st shot), accompanied by aural fullness in right ear and dizziness. Symptoms abated over time, but remain mildly present two weeks later.
37 2021-03-24 lip swelling, swollen tongue Patient complained of having trouble breathing following receiving her vaccine. When observed her b... Read more
Patient complained of having trouble breathing following receiving her vaccine. When observed her bottom lip was swollen and swelling of her tongue was noted. An epi pen was administered and 911 was called. She was monitored and vitals were assessed until an ambulance arrived and was able to transport her to the hospital
37 2021-03-24 taste disorder, smell distorsion Things tasted a little funny but I mostly noticed it with coffee; Exactly two weeks after the first ... Read more
Things tasted a little funny but I mostly noticed it with coffee; Exactly two weeks after the first vaccine I started smelling cigarette smoke and a sweet garlicky smell; This is a spontaneous report from a contactable healthcare professional (patient). This 37-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EJ1685) via an unspecified route of administration on 07Jan2021 at 09:30 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine, the patient was not diagnosed with COVID-19. Concomitant medications included a multivitamin and an estrogen supplement. The patient previously received sulfa and clindamycin from unknown dates for unknown indications and experienced allergy. Exactly two weeks after the first vaccine on 21Jan2021 the patient experienced smelling cigarette smoke and a sweet garlicky smell. Things tasted a little bit funny but she mostly noticed it with coffee. She thought maybe she had a cold. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events.The outcome of smelling cigarette smoke and a sweet garlicky smell were not recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
37 2021-03-24 visual impairment On 3/25/21 at 1220 Pt received her first Pfzier vaccine to the left deltoid and was sitting in the p... Read more
On 3/25/21 at 1220 Pt received her first Pfzier vaccine to the left deltoid and was sitting in the post vaccine observation site under 15 min observation. Pt was witnessed slumping down in chair by nurse at 1225 and then became unconscious with eyes gazed and to the right with snoring respirations. Pt was assisted to the floor by two nurses without any trauma lying supine and legs elevated. VS were taken 122/60,59,20 and SPO2 87%. Pt woke while BP was being taken and started talking and was A&OX4. Pt was placed on oxygen at 10LPM with NRB mask. SPO2 increased to 99%, pt's skins were W/D with good color. Pt denied any SOB, itchy throat or difficulty swallowing, rash or hives. Pt was feeling a bit better and oxygen was taken off. Pt was then sat up with legs straight while on the floor to repeat VS at 1231 Pt's BP was 70 systolic, pluse of 58, SPO2 dropped again to 87% and pt became vere dizzy and vision blackening and was layed back down immediately with legs elevated and NRB mask at 10 LPM was placed back on with increased SPO2 of 99%. Pt had positive orthostates. Pt also c/o tingling hands. 911 was contacted at 1234. VS at 1241 were 106/60, 62, 20 and SPO2 of 100%. Pt's husband was at her side. 1247 engine co 54 arrived onscene and report was given to paramedic. AMR unit 460 arrived approx 2 min later. Pt was assessed and transported to closest ER.
37 2021-03-26 eye strain Started with lethargy and hot flashes, followed by extreme shortness of breath, difficulty speaking ... Read more
Started with lethargy and hot flashes, followed by extreme shortness of breath, difficulty speaking and holding up my head and keeping my eyes open. Then trembling. The local nurse at the vaccination sight reported high blood pressure, rapid pulse and seemingly extremely low blood sugar. I didn?t go to the ER because my supervisor agreed to take me home since we were volunteering at the sight prior to me receiving the vaccine. I had to keep eating every hour or so due to blood sugar seeming very low. Shortness of breath continued. Pulse rate still high as I could sleep with my head down due to racing pulse in my head. Later that night I had small bumps on my arms with no itch. Then I had extreme fatigue and muscle fatigue. I kept experiencing extreme episodes of hot flashes. I woke up in the middle of the night with a headache and uncomfortable hot flashes. I drank 100% juice and ate a few goldfish. I had mild nausea and food aversions. The next day the bumps were gone. I went to work but was sent home. I was told I should have gone to the ER but I don?t have insurance. Once home, I went through 5 hours of extreme chills unlike anything I have ever experienced. I had to cross my arms over my chest and stack on blankets to regulate. If I moved my arms for more than five minutes or pulled the blanket down, I began uncontrollably trembling. I still had trouble regulating my blood sugar on day two. It?s day three and no bumps and no chills. Less muscle fatigue as well. I am still pretty exhausted and tire easy when doing things. I did experience the common soreness in the muscle the vaccination was administered, but I figure that is normal. I am hopeful that I am improving and out of the danger zone. I took Garden of Life Elderberry with added nutrients last night and today I took my normal detox probiotic. I have been pushing fluids and have broken my intermittent fasting to try and keep my blood sugar up. I feel like my system is finally regulating and now I just have lingering exhaustion from the events that took place.
37 2021-03-26 lip swelling I want to make a report because I had a sole of my foot that started swelling (mild) on Thursday (I ... Read more
I want to make a report because I had a sole of my foot that started swelling (mild) on Thursday (I got my shot on Wednesday). Then after that it felt my forehead akin was swelling. Now my chin and lips and right foot are swelling more. Other (more normal) side effects I had were: tired and headache, on Wed night fever and nausea (only short time, 1-2 hours), On Thu swelling started (See above for description) and pain underneath my left armpit and swelling there too, small shocks/cramps in my arm muscles, especially left side.
37 2021-03-28 taste impairment Pain and swollen right arm where shot was given. Metal taste in mouth that has not gone away yet. Ta... Read more
Pain and swollen right arm where shot was given. Metal taste in mouth that has not gone away yet. Taste like a coin is in mouth. Started between 30- 1 hour after shot and still tasting it a day later
37 2021-03-28 eye movement disorder, double vision FEELING CROSS EYED ANXIOUS SEEING DOUBLE,OBSERVED FOR 20 MORE MIN. HAD HER DRINK WATER, S/S RESOLVED... Read more
FEELING CROSS EYED ANXIOUS SEEING DOUBLE,OBSERVED FOR 20 MORE MIN. HAD HER DRINK WATER, S/S RESOLVED OWN, PATIENT STATED DID NOT EAT WELL, ADVISED TO GO GET SOME FOOD, HAS CELIAC DZ DECLINED CRACKERS. 1314-150/96 98% 24 95 1132 130/86 96% 16 92
37 2021-03-28 lip swelling Immediately S/P vaccine pt experienced diarrhea for 7 days. 1.3 wks post vaccine pt began experienc... Read more
Immediately S/P vaccine pt experienced diarrhea for 7 days. 1.3 wks post vaccine pt began experiencing HA with tachycardia (120bbm) at 1.5 wks pt began experiencing swelling in the face and neck which worsened around the lips ending in fever blister. She has lymphadenopathy anterior cervical.
37 2021-03-28 pupils dilated Pt received vaccination and had left facility and was driving away from the center when she develope... Read more
Pt received vaccination and had left facility and was driving away from the center when she developed red skin, was pale, huge pupils, and throat felt thick and full. She stated she was "about to pass out". Returned to center and was further evaluated. At 1832 BP 124/71, HR 98, 99% on Room Air; 1826 104/72, 112, 99% on RA. At 1828 she received 50 mg Benadryl in her Left Arm via IM injection. At 1838 131/79, HR 92, 100% on RA. Pt stated she felt better and was wheeled out of the facility at 1850 accompanied by significant other. Pt was advised to get rest and monitor symptoms.
37 2021-03-29 lip swelling, lip blister Vaccine at 7:30am. Noticed swollen lip with blister at about 11:45am. Had a video appointment/evalua... Read more
Vaccine at 7:30am. Noticed swollen lip with blister at about 11:45am. Had a video appointment/evaluation about 12:15pm and was advised to take two Benadryl and repeat every six hours for 24 hours or until swelling subsides. Was advised to go to ER if symptoms worsened.
37 2021-03-30 dry mouth Spotting/vaginal bleeding began 2 days after first dose and lasted 1 week. Dry mouth began within mi... Read more
Spotting/vaginal bleeding began 2 days after first dose and lasted 1 week. Dry mouth began within minutes of first dose and lasted 2 weeks. Sore/itchy arm 1 week after first dose and lasted a few days.
37 2021-03-30 oropharyngeal discomfort, tongue discomfort, swollen tongue About an hour after the shot I felt my tongue swell slightly. Drinking water helped at first but abo... Read more
About an hour after the shot I felt my tongue swell slightly. Drinking water helped at first but about 20 mins after that I felt my throat get tight in the back. Went and received an epi shot. Paramedics took me to ER at the Hospital. In ER I received a a second epi shot about an hour after admission as tightness as starting again. Benadryl, prednisone and Pepcid was also given. I was admitted for observation for close to 28 hrs. Following morning I was given more prednisone and Benadryl. It?s been 3 weeks and I still have side effects with throat and tongue discomfort at night and when laying down. Awaiting results from follow up testing.
37 2021-03-30 swollen tongue, swelling of eyelid, ear discomfort 30 minutes after vaccination, had a prickly/burning sensation in the neck and ears. Face and tongue ... Read more
30 minutes after vaccination, had a prickly/burning sensation in the neck and ears. Face and tongue began to swell. Had some swelling of the eyelids
37 2021-03-30 swollen tongue tongue swell and throat close.; tongue swell and throat close.; still have lingering side effects wi... Read more
tongue swell and throat close.; tongue swell and throat close.; still have lingering side effects with breathing; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eng206), via an unspecified route of administration, administered in arm left on 08Mar2021 15:45 as a single dose (at the age of 37-years-old) for covid-19 immunisation. The patient had no known allergies or other medical history. The patient was not pregnant at the time of vaccination. There were no concomitant medications. On 08Mar2021 17:00 (as reported) about an hour after receiving the first does, she felt her tongue swell and throat close. Resulted in multiple epi shots, hospitalization and still have lingering side effects with breathing. The reported events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for 2 days. The patient received epi shot in urgent care, another at hospital. The outcome of still lingering side effects with breathing was not recovered, while recovered on an unspecified date for the other events.
37 2021-03-30 vision blurred Dizziness, blurred vision, extreme aches, joint aches, difficulty walking, nausea, fever, chills, th... Read more
Dizziness, blurred vision, extreme aches, joint aches, difficulty walking, nausea, fever, chills, throw up, rash all over body, difficulty breathing, migraine
37 2021-03-31 loss of smell loss of smell 4/1 arm soreness 3/31 arm redness 4/1 underarm soreness 3/31
37 2021-03-31 dry throat Within 15-20 minutes: Dizzy and lightheaded. Hard to think clearly. Headache. High heart rate and he... Read more
Within 15-20 minutes: Dizzy and lightheaded. Hard to think clearly. Headache. High heart rate and heart arrhythmia. Pin prickly over whole body, then itchy. Heavy throat and chest, tight throat, hard to breathe, dry and phlegm feeling in throat (was very hydrated. 64 plus oz water that day). Low blood pressure, icy cold limbs. Face might have swelled slightly I was concentrating on breathing. Took 2 Benadryl per pharmacy directions, probably around 5:25. Symptoms stayed consistent for 2/3 hours and started subsiding. Hour 6: Took a Benadryl and 2 Tylenol to and went to sleep. The itchiness has continued
37 2021-03-31 eye pain Muscle aches, fatigue, low-grade fever all lasted about 24 hours. Headache and eye pain were severe ... Read more
Muscle aches, fatigue, low-grade fever all lasted about 24 hours. Headache and eye pain were severe and lasted 72 hours before subsiding. I?m still managing a headache but believe it may now be from allergies/stress.
37 2021-03-31 mouth numbness, visual impairment couldn't see right; Felt like she was going to throw up; lips, tongue, face, hands and arms went num... Read more
couldn't see right; Felt like she was going to throw up; lips, tongue, face, hands and arms went numb; lips, tongue, face, hands and arms went numb; Extreme weakness and dizziness; Extreme weakness and dizziness; had chest pains that would come and go near my heart; This is a spontaneous report from a contactable consumer reported for self. This 37-year-old female no pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 12:00 Left arm at single dose (Lot EM9810) for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Hashimoto's thyroiditis (autoimmune disease) and Allergies to food and Gluten, methergine. No covid prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), and calcium carbonate, colecalciferol (VITAMIN D 2000). No other vaccine in four weeks. Extreme weakness and dizziness, lips, tongue, face, hands and arms went numb. She couldn't see right. Had chest pains that would come and go near heart. Felt like she was going to throw up. The numbness only lasted about an hour. The extreme weakness and dizziness lasted about a day. The chest pains started about an hour after the vaccine was given and lasted on and off for about 12 hours. All events were on 03Mar2021 and non serious. No covid tested post vaccination. No treatments were received. Outcome of the events was unknown. Information about batch number has been requested.
37 2021-03-31 toothache Upper back molar pain on both sides of my mouth. More specifically, the gums above/between my back t... Read more
Upper back molar pain on both sides of my mouth. More specifically, the gums above/between my back two molars is sore to the touch. I have good dental hygiene and this pain started in both right and left upper back molars after the vaccine. It's a constant, but mostly bearable pain that is heightened by pressure such as chewing or clenching my jaw together. Just to give an idea, eating thin apple slices is painful.
37 2021-04-01 ear infection, ringing in ears Sinus inflammation, aura migraine, double ear infection. Ringing in left ear two days after vaccine,... Read more
Sinus inflammation, aura migraine, double ear infection. Ringing in left ear two days after vaccine, ear infections diagnosed 8 days post shot. Augmentin and allergy pills prescribed..
37 2021-04-01 mouth swelling, lip swelling Swollen mouth and lip and rash
37 2021-04-01 oropharyngeal discomfort I had a couple of episodes where I felt like I swallowed something and couldn?t catch my breath afte... Read more
I had a couple of episodes where I felt like I swallowed something and couldn?t catch my breath after the shot during the day. Then I woke up about 3am and had a hard time breathing and felt like I was having an asthma attack. I have not had any issues with my asthma since I was child unless I was around environmental factors like smoke, perfume, air fresheners, etc. The next day I went to work and had a few more of those episodes throughout the day. Then after giving report at 7:00pm I felt like I was choking on something and couldn?t catch my breath. Maybe 15min of trying to cough and catch my breath, I was finally able to breath, but I felt like there was something in my throat. I felt like I was breathing through a straw. I ended up driving home and having another episode where I couldn?t breath, but I was also having left sided numbness and weakness. My left hand acted like I had a contracture and it was stuck like that. I also had numbness around my mouth and my jaw felt like it was hard to move. I ended up going to the ER They said I looked like I was having a stroke. They worked me up for a stroke, which was negative. Despite telling them I couldn?t breath, they decided I was having a panic attack for no reason. I begged for a breathing treatment and finally got that and an inhaler which helped. I also reported that I had just got my vaccine and no one would listen to that.
37 2021-04-03 ear pain Tingling pain in left ear start 5 minutes after vaccine, spread to left side of face 10 min after va... Read more
Tingling pain in left ear start 5 minutes after vaccine, spread to left side of face 10 min after vaccine & subsided within a couple hours
37 2021-04-03 mouth tingling, ear discomfort, feeling of choking After a few minutes, I started to feel chest pains which started to intensify, then my breathing sta... Read more
After a few minutes, I started to feel chest pains which started to intensify, then my breathing started to get shallow. Next, I was feeling tingling in my extremities. Then like the flick of a switch, I went into anaphylactic shock. I couldn't breathe and struggled to get the words out to get an epi pen. I was then injected with 3 epi pens while the ambulance was called. I also felt tingling in my tongue and mouth. The following day at home, I had another reaction. It started with tingling in my throat then the shallow breathing again. Chest pains again, then anaphylactic shock again. The next day, allergy symptoms came back, but not anaphylactic shock. This time, the addition of burning in my biceps on both sides, which traveled down to my forearms. Later on, the burning traveled down my torso to my legs. There is also some burning in my ears and scalp. My breathing is shallow, and it seems like when the allergy meds start to wear off, the symptoms keep coming back. They're happening now as I write this
37 2021-04-04 eye discomfort, bloodshot eyes, swelling of eyelid Right eye, redness and swelling of eyelid. Discomfort when blinking.
37 2021-04-04 taste disorder On 3/19/21, presented to ED with new right facial droop and numbness. CT head negative, neurology co... Read more
On 3/19/21, presented to ED with new right facial droop and numbness. CT head negative, neurology consult and thought to be Bell's Palsy. Discharged home on Solumedrol 5 day pack. Patient noted asymmetry in her taste sensation and then started to have R sided facial pain, followed by R sided facial droop. On 3/23/21, brain MRI showed no acute infarction, intracranial hemorrhage or mass lesion, very minimal asymmetric enhancement of the labyrinthine segment of the right facial nerve as compared to the left side.
37 2021-04-04 ringing in ears Tinnitus one approximately three days after vaccine. This symptom has not stopped since the vaccinat... Read more
Tinnitus one approximately three days after vaccine. This symptom has not stopped since the vaccination administration as well as increased in severity.
37 2021-04-05 eye pain - I had a severe headache within 4 hours of receiving the vaccine. Behind my eyes.
37 2021-04-06 drooling, mouth numbness Approximately 21 days after second vaccine, employee began to have neurological symptoms consisting ... Read more
Approximately 21 days after second vaccine, employee began to have neurological symptoms consisting of right side facial numbness, drooling, tongue numbness, right arm/foot numbness. Employee was hospitalized for nine days and diagnosed with Nervitis/Myelitis. She has again been hospitalized (4/6/21) with worsening symptoms.
37 2021-04-06 eye pain Received 2nd dose on 4/2/21 at 12:15 pm. By 6 pm, I was absolutely exhausted. Woke up next day (Satu... Read more
Received 2nd dose on 4/2/21 at 12:15 pm. By 6 pm, I was absolutely exhausted. Woke up next day (Saturday at NOON, which is not like me after having very vivid dreams is someone in my past. Felt like I had been run over by a semi truck. Had body coaches and couldn?t stop sweating. Finally took Motrin around 2 or 3 pm. An hour later my temperature was 99.3 F. By 7pm I had to take more Motrin because my temperature was 99.3 again. By 8 pm, I almost fell over walking to the kitchen to warm up soup. Sunday, did not trust myself to drive to my mothers for breakfast. Freezing cold all day. No shiver just cold. Temperature was 97.3 all day. Monday and Tuesday, 4/5 and 4/6 I had a splitting migraine which felt like I had alternating pouring from a hammer or an axe. Tuesday woke up with what felt like my head was split open. Severe pain behind my eyes and the entire head. Stiffness in my neck, especially left side and down the left shoulder. Slight lingering headache on Wednesday 4/7
37 2021-04-06 bloodshot eyes persistent fever despite Tylenol, started a few hours after vaccination, "blood shot" eyes, admitted... Read more
persistent fever despite Tylenol, started a few hours after vaccination, "blood shot" eyes, admitted to hospital
37 2021-04-06 visual impairment At the moment after the injection not even 10 mins I started to feel weakens all over, like passing ... Read more
At the moment after the injection not even 10 mins I started to feel weakens all over, like passing out, hot running trough my body, low heart rate, lots of chest heart pressure, sensations of throat closing, nausea & vomiting. Heart rate was down to 30, very very weak and hot flashes, pale, and couldn't see much. Will tell the paramedics I couldn't breath to give me something. I asked why was a feeling like this, if this is a reaction to the shot. They said no that is more like dehydration, and took me to the ER. ER did an EKG and results where normal. They took out blood work took hours to give me results, had me waiting in the ER waiting area. Didn't give me proper care especially coming from the injection site. I walked out of the ER once I felt better.
37 2021-04-07 mouth tingling Patient reported that upon rcvding the 1st dose she experienced an immediate electric shock in her j... Read more
Patient reported that upon rcvding the 1st dose she experienced an immediate electric shock in her joints specifically in the knees and ankles, which went away immediately. Then approx. 25 minutes later she experienced tingling lips which went away, and soreness in her left arm (lasted for approx. 30 hours before it went away). Approx. 30 hours from rcvding the vaccine she reported having a hive reaction on her left upper arm (described as 1 small bump size of a pencil eraser and it was itchy), and then approx. 48 hours from the vaccine she noticed another hive spot on her left shoulder blader (described as 1 small bump size of a pencil eraser also) - upon discovering these hive spots she reported they disppear immediately. Approx. 4 days from the vaccine date she experienced diarrhea which lasted for 4 days (diarrhea was worse in the morning compared to in the evening). She also experienced food diversion for a few days. What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): Patiented reported she had applied an ice pack on her left arm - this caused the bump to disappear immediately. Also stated she took Tylenol for her headache. Ever have a reaction to a previous vaccine? If yes, what? None. ***NOTE*** Patient called because she was concerned about getting her 2nd Pfizer dose (schedule for 4/6/2021) based on her 1st reactions to the vaccine. Patient reported she had been in contact with her PCP and even reached out to Pfizer regarding her concerns but got no where. Discussed with patient that based on the ADE she provided and her medical history, these are not a contraindication from getting the 2nd dose. The decision would be up to her based on the informations provided and benefits vs risks assessment. Suggested that she can consider getting her 2nd dose at a hospital or at PCP office so she can be monitor a little longer by a healthcare professional if she was concern (patient reported that she have the 2nd dose schedule to be administer at a hospital on 4/6/2021). Recommend that if she experience any localized reactions upon rcvding 2nd dose, can take Benadryl (counseled can experience drowsiness).
37 2021-04-07 swelling of eyelid Patient notified staff at 0955 she had developed sore thoart. she did not have prior to vaccine. rig... Read more
Patient notified staff at 0955 she had developed sore thoart. she did not have prior to vaccine. right eyelid swelling appeared at 1000. facial swelling at 1005.
37 2021-04-07 ringing in ears start to develop tinnitus after receive the vaccine.
37 2021-04-07 vision blurred Blurred vision after 20 minutes, lasted 10 minutes and resolved. Coughing and slightly swollen thro... Read more
Blurred vision after 20 minutes, lasted 10 minutes and resolved. Coughing and slightly swollen throat after 30 minutes, lasted 15 minutes and resolved. Bloody spit after coughing but resolved after an hour. Fatigue after 2 hours, extreme headache and nausea began after 4 hours. All were reduced after 12 hours, but none have resolved yet 48 hours later.
37 2021-04-08 eye swelling Left eye is swollen. Puffiness is around the whole eye socket, but more so below the eye. No pain, b... Read more
Left eye is swollen. Puffiness is around the whole eye socket, but more so below the eye. No pain, but it feels as swollen as it looks. I?ve taken one Aleve, two allergy pills (the Walgreens version of Allegra) , and used a cold eye compress. It is still swollen as of 7:47 pm ET. It has not improved that much, but it has not gotten worse. I don?t know if this swelling is due to the vaccine, as my arm feels sore but okay, or possibly a poorly timed mosquito bite in the middle of the night (as there was one in my room last night).
37 2021-04-08 lip blister I did get the arm soreness like I get from the Flu shot for about 48 hours in the left arm where I w... Read more
I did get the arm soreness like I get from the Flu shot for about 48 hours in the left arm where I was injected. I'm not sure if this because of the shot, but about 5 days after I discovered a blister or boil on my back right shoulder and then another on my left shoulder. 7 days after the shot there was another blister in my mouth bottom lip and 9 days after I found another blister on my inside right little toe.
37 2021-04-08 ringing in ears, extreme sound sensitivity Having non stop low frequency tinnitus that I have not experienced before. Interrupt rest at night a... Read more
Having non stop low frequency tinnitus that I have not experienced before. Interrupt rest at night and distract work during work. Sometimes it goes extremely loud that really hard to handle. It becomes very sensitive responds to sounds.
37 2021-04-08 eye floaters, mouth tingling within minutes felt an intense systemic response. broke out in a sweat clammy sweat above upper l... Read more
within minutes felt an intense systemic response. broke out in a sweat clammy sweat above upper lip tingle/prickly feeling over body in fingers and toes dizzy heart palps gumby/jelly like limbs face muscles around mouth affected eye floaters splitting headache that started at base of skull and wrapped around to top of head and temples As response progressed extremities started to tremble teeth chattered fatigue nausea 4-8 in the evening (over 24 hrs later) intense sweating difficulty swallowing brain fog
37 2021-04-09 ringing in ears Headache, dizziness, tinnitus, arm tingling, hot and cold flashes (pre-syncope sxs)
37 2021-04-10 lacrimation increased, tongue itchiness, mouth tingling, feeling of choking Out for a run that evening (8 hours after shot) after about 12-15 minutes of running I stopped to wa... Read more
Out for a run that evening (8 hours after shot) after about 12-15 minutes of running I stopped to walk and started sneezing a lot, about 8 - 10 times. Then my nose started to run, eyes started to water a little followed by tingling & itching on the back of my tongue and throat, then swelling on the back of my tongue. I felt a little light headed a few minutes later, I slowed to an even slower walking pace. The swelling did not get worse. Blood pressure was fine when checked at home about 30 minutes after the start of the episode, a little high for me if anything, but normal. My nose become fully congested which was the only side effect that lasted for a couple of hours. Yes, it is spring here but I do not have allergic reactions beyond a few sneezes and slight runny nose to spring pollen. This was much more intense and I have never experienced tongue and throat swelling.
37 2021-04-10 swollen tongue I first got a bad headache and dizzy. They brought me back behind a curtain with an emergency person... Read more
I first got a bad headache and dizzy. They brought me back behind a curtain with an emergency person. I got very dizzy and nauseous after that. They had me lay down on a cot. About 30 minutes after I received the vaccine, they brought me out to my husband?s vehicle in a wheelchair. By that time, I was so dizzy that I could hardly stand by myself. I was told to call my primary care doctor. My husband called them while we were headed home. My tongue was swollen a little. We decided to go to my father in law?s home, since he is a doctor. By the time we got there, I was coughing. We were still on hold for a nurse at my primary care doctor?s office. I started getting hives on my chest and neck and wheezing around the same time. We left before seeing my father in law to go home and use my nebulizer. For the moment, I used my inhaler, which doesn?t work as well. Once we got to my driveway, a nurse from my PCP office said to go straight to the emergency room. I spent the night at the hospital that night and was treated for an allergic reaction, which resolved the issues. I continued medications at home after leaving the hospital the following day.
37 2021-04-10 thirst, taste impairment 5-10min post injection: metallic taste in mouth 1 hr post injection: sudden dry skin, increased thir... Read more
5-10min post injection: metallic taste in mouth 1 hr post injection: sudden dry skin, increased thirst, increased urination, pulse at mid 80s, oxygen saturation at 98 12hrs post injection: diarrhea for 1 hr 18hrs post injection: fever/chills , headache, dizziness & nausea develop; pulse increases to high 90s and oxygen dropped to low 90s 24hrs post injection: fever at 102.4-102.8, increased pulse, oxygen dropped to high 80s. 28-33 hrs post injection: pulse at low 100s, oxygen saturation between 86-90, squeezing chest pain on some beats, handheld ekg monitor detects multiple possible vpb RonT , blood pressure 128/68 45 hrs post injection: oxygen saturation in low-mid 90s, fever dropped to 100-101, No abnormal beats detected on EKG monitor. Nausea gone. 48-54 hrs post injection: fever drops to 99.
37 2021-04-11 eye swelling The following early morning hours, right eye was swollen and throat was incredibly itchy. Took Benad... Read more
The following early morning hours, right eye was swollen and throat was incredibly itchy. Took Benadryl throughout day and monitored symptoms while at work and contacted my family doctor to notify. Around 4pm on 3/23/21, the itchy throat sensation had subsided and the right eye was less swollen. By the next day, 3/24/21, my right eye returned to normal.
37 2021-04-11 lip swelling, swelling of eyelid Sweeping of eyelids and upper lip, stayed swollen for over 24 hours.
37 2021-04-11 ringing in ears, ear discomfort The next morning I woke up with a feeling of clogged ears. It was hard to hear. Feeling for better o... Read more
The next morning I woke up with a feeling of clogged ears. It was hard to hear. Feeling for better over the last few days but now on the 7th day I can barely hear out of my right ear. Have been trying to ?pop? my ears to relieve pressure. Nothing helps. Slight ringing in my right ear as well.
37 2021-04-12 lip swelling I felt a tingling sensation between my chin and my lower lip, it got a little swollen. It lasted tw... Read more
I felt a tingling sensation between my chin and my lower lip, it got a little swollen. It lasted two days. I also felt heat all over my face where my mask used to be, it lasted several minutes.
37 2021-04-12 swollen tongue About 45 minutes-an hour later, my tongue swelled a little, cheeks swelled, left side of face and ch... Read more
About 45 minutes-an hour later, my tongue swelled a little, cheeks swelled, left side of face and chin swelled. I also had a rash on face. Swelling and Rash lasted about an hour or so.
37 2021-04-13 loss of smell, taste impairment Mild dyspnea, cough, chills, myalgia, headache, anosmia and dysgeusia no treatment
37 2021-04-13 dry throat Patient went directly to a gurney for her 15 mins observation because patient stated she had dizzine... Read more
Patient went directly to a gurney for her 15 mins observation because patient stated she had dizziness during her first dose of Pfizer. Patient c/o dizziness, nausea. Patient stated has history of gastric issues and has sensitivity. Patient verbalized that she gets nauseated. Patient lying on gurney bed and given some snacks and water since patient stated her throat was dry. Also patient was monitored for 30 mins and taken vital signs: BP (127/81); HR: 80; RR: 16, O2 Sat 98%. Around 1:35 PM, no N/V no dizziness noted. Patient discharged and patient stated feeling better, no more dizziness. Patient stated she has a ride home with accompanying husband.
37 2021-04-13 ear discomfort Covid symptom onset 3/18/21 in the evening. Went to sleep early at 6:30 pm, woke at midnight with ch... Read more
Covid symptom onset 3/18/21 in the evening. Went to sleep early at 6:30 pm, woke at midnight with chills (no fever). Others symptoms include cough, headache, nasal congestion, "plugged ears", chest tightness. Rapid test, Binax now, was performed 3/19 am and was negative. Symptoms worsened so scheduled a PCR test at Walgreens on 3/22. Received results three days later that it was positive. 4/13/2021, still symptomatic. Seen at walk-in and prescribed albuteral inhaler.
37 2021-04-13 tongue discolouration Patient woke up the next morning after receiving vaccine and said she had a white, fuzzy tongue and ... Read more
Patient woke up the next morning after receiving vaccine and said she had a white, fuzzy tongue and it did not go away with brushing her teeth. I looked up side effects and nothing like that was listed. Told her I could not confirm or deny that it was caused by the vaccine and advised her to contact a doctor.
37 2021-04-13 visual impairment dizziness strange visual sensation
37 2021-04-14 loss of taste, loss of smell tested positive for Covid 19 4/09/2021 symptoms were mild and able to treat at home. symptoms includ... Read more
tested positive for Covid 19 4/09/2021 symptoms were mild and able to treat at home. symptoms included loss of taste/ smell, severe sinus congestion/ headache, fatigue, and muscle weakness
37 2021-04-14 loss of smell, loss of taste Lose of taste and smell, headache.
37 2021-04-14 taste impairment Metallic taste in mouth, left hand is very numb ( which is same side as injection site), but right h... Read more
Metallic taste in mouth, left hand is very numb ( which is same side as injection site), but right hand is numb some too
37 2021-04-14 ringing in ears Persistent ringing in the ears
37 2021-04-15 mouth tingling Patient reported tingling in gums, feeling faint, shortness of breath, is 22 weeks pregnant. Checke... Read more
Patient reported tingling in gums, feeling faint, shortness of breath, is 22 weeks pregnant. Checked out by Emergency Medical Services.
37 2021-04-15 swollen tongue, tongue itchiness Tongue swelling - occurred hours after receiving vaccination on 4/9. Swelling subside after 1-2 hour... Read more
Tongue swelling - occurred hours after receiving vaccination on 4/9. Swelling subside after 1-2 hours Throat closing sensation - symptoms started on 4/11. Treatment - Benadryl, Claritin, Motrin, honey, warm water, gargle salt water. Swelling occurred on 4/11 and 4/14-15; still experiencing the symptoms as of today - 4/16. Tongue itching - occurred hours after receiving vaccination on 4/9. Still experiencing symptoms today - 4/16
37 2021-04-15 swollen tongue Patient states that 10 minutes after getting her 2nd Covid vaccine, she started to feel her tongue s... Read more
Patient states that 10 minutes after getting her 2nd Covid vaccine, she started to feel her tongue swelling. Denies any difficulty swallowing , denies chest pain, denies palpitations. No observation of redness, swelling o face hnds or feet. Vitals signs obtained 0930 BP 117/72 HR 52bpm Sp02 100% , and 1006 BP 103/63 HR 52bpm Sp02 100%. No RRT called. Pt left clinic by herself 1010
37 2021-04-15 visual impairment Freezing cold, could not warm up for hours. Very mild fever. Eyes were foggy and dazed. Very little ... Read more
Freezing cold, could not warm up for hours. Very mild fever. Eyes were foggy and dazed. Very little movement could be made. Headache.
37 2021-04-16 taste impairment Slight aftertaste in my mouth 5 mins out., 20 minutes out i had a warm fuzzy feeling in my front sto... Read more
Slight aftertaste in my mouth 5 mins out., 20 minutes out i had a warm fuzzy feeling in my front stomach that stayed all afternoon. Around 10:17 I wasnt able to walk around for long periods of time bc I felt winded. When I got home from the shot I slept for about 7 hrs
37 2021-04-16 taste impairment Lethargic -3 weeks Heart palpitations- 2 days Chills - 4 days Left arm limited mobility- 7 days Hea... Read more
Lethargic -3 weeks Heart palpitations- 2 days Chills - 4 days Left arm limited mobility- 7 days Headache- 7 days Metallic taste in mouth - 3 weeks
37 2021-04-16 eye movement disorder In the evening on March 15th, she began having shortness of breath and chest pain. She asked her boy... Read more
In the evening on March 15th, she began having shortness of breath and chest pain. She asked her boyfriend for her blood pressure cuff so she could take her blood pressure. As he was getting it she told him to call 911 and then her eyes rolled back in her head and she stopped breathing. Paramedics attempted to revive her but were unsuccessful. She was taken to the hospital and pronounced dead. Cause of death listed as heart disease.
37 2021-04-16 swollen tongue, lip swelling Client had first dose approximately 12:15 pm, allergy to sulfa drugs. At 1:15pm tongue swollen, lip... Read more
Client had first dose approximately 12:15 pm, allergy to sulfa drugs. At 1:15pm tongue swollen, lips swollen, hives on tongue, trouble swallowing. Epi (0.3 mg) given at 1324, Benadryl 50 mg at 1324, called 911 at 1324. Client transported to hospital by EMS.
37 2021-04-17 dry throat I was given the Pfizer vaccine at 7:30am and waited for 20 minutes. I headed to my car and started d... Read more
I was given the Pfizer vaccine at 7:30am and waited for 20 minutes. I headed to my car and started driving home. A few miles down the road I started getting tingly on my left arm (where the shot was administered), then it traveled up to my face and down my left leg. I realized I was getting lightheaded but I was driving on Hwy 75 and needed an exit FAST. Thankfully I was safely able to exit and park in the Mall parking lot. I called husband and my dr immediately to let them know where I was and I needed help. As I?m talking to them my throat started getting cottony and tight, and that tingly feeling that made it?s way down my left side was coming up my right side. When it got to my heart it hit my heart with a *boom* like a really hard heartbeat. I was seriously freaking out and thinking I am going to pass out and no one is going to be able to find me. My dr's office advised me to go to an ER. I found a small ER across the highway from me and decided my lightheadedness had subsided enough that I could get there. They monitored me for an hour, gave me no meds, did an EKG and discharged me once they felt my symptoms had mostly stopped. No discharge instructions other than to follow up with my dr. My dr has never responded to my efforts to reach her. For the remainder of that day and the next day I continued to feel itchy, a cottony throat, and like I was getting pricked with needles all over my body, but specifically on my fingertips and the back of my knees. A friend suggested I take some Benadryl, and that drastically improved those lingering symptoms. I took 10ml of Children's liquid Benadryl on April 13 at 8:00pm, and since it made me feel better, I did the same dose again on April 14 at 9:00pm. I was doing fairly well other than being very tired and sleeping quite a bit: 5-6 extra hours each day. On April 16 at 4:45pm I stood up and then leaned all the way over to the ground to pick something up and my heart beat super hard again, and I felt like I was going to throw it up. I got lightheaded and my heart just hurt afterward so my husband took me to another ER. They did another EKG, took a chest X-ray, did some blood tests, gave me baby aspirin and some anxiety medication by IV. After monitoring me for a couple fo hours, they sent me home to rest. My heart has been very sore ever since.
37 2021-04-17 ear discomfort anaphylactic shock; chest pains; tingling in extremities; shortness of breath/couldn't breath; wheez... Read more
anaphylactic shock; chest pains; tingling in extremities; shortness of breath/couldn't breath; wheezing; Throat closed; chest tightened; burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning; Scalp and ears also burning; ears also burning; Itchy throat all days; couldn't breath or talk; This is a spontaneous report from contactable consumers. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 13:30 (Lot Number: EW0151) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included fish, tree nuts, peanuts allergy, in-door & outdoor environmental allergies, pet dander allergy, rheumatoid arthritis, asthma, GERD, chronic dry eye and ADHD; all from an unknown date and unknown if ongoing. Concomitant medications included albuterol, lifitegrast (XIIDRA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), prednisone, cetirizine hydrochloride (ZYRTEC) and etanercept (ENBREL); all taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 31Mar2021 13:45, the patient began with chest pains, then tingling in extremities, then shortness of breath & wheezing. Suddenly, was in anaphylactic shock. The patient experienced throat closed, chest tightened, couldn't breath or talk. Same symptoms came back on 01Apr2021. The patient went to emergency room/department or urgent care. The patient stated, "I went into anaphylactic shock again and back to hospital. The following day, anaphylaxis re-turned, but no anaphylactic shock. Shortness of breath, burning in arms that traveled down my arms then into my torso and legs. Itchy throat all days. Scalp and ears also burning. Today, on day 4, still feeling the burning and trouble breathing. Every time the Benadryl wears off, it feels like it's still attacking my body". Treatment for the events was received such as 3 epi-pen injections, EKG, IV of Benadryl and IV of steroids. The outcome of the event "burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning" was unknown and the outcome of the rest of the events was not recovered. The patient was hospitalized due to event anaphylactic shock that was also reported as life threatening.
37 2021-04-17 mouth numbness Sensation of numbness in the upper lip mouth, palate, nose and pomulos
37 2021-04-17 vision blurred, eye swelling, eye irritation Symptoms: Sore throat Swollen eyes Feverish/chills Headache Burning eyes High heart rate Labored bre... Read more
Symptoms: Sore throat Swollen eyes Feverish/chills Headache Burning eyes High heart rate Labored breathing when moving Dizzy/blurred vision Sore arm
37 2021-04-17 vision blurred Dizziness; blurred vision; joint aches; extreme pain; difficulty breathing; fever; chills; sweats; l... Read more
Dizziness; blurred vision; joint aches; extreme pain; difficulty breathing; fever; chills; sweats; large rash; This is a spontaneous report from a contactable consumer. A non-pregnant 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 21Mar2021 at 15:30 (Batch/Lot Number: EN 62v3) at 37-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient's medical history included gluten allergy from an unknown date and unknown if ongoing, COVID-19 prior to vaccination from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 28Feb2021 (Lot Number: EN6201, administration time 15:30, location: Left arm, dose number: 1). On 22Mar2021 02:00, the patient experienced: dizziness, blurred vision, joint aches, extreme pain, difficulty breathing, fever, chills, sweats, large rash; all of which required a visit to a doctor or other healthcare professional office/clinic, emergency room/department or urgent care and hospitalization. The patient was hospitalized for all of the events for 1 day. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Mar2021. Therapeutic measures were taken as a result of the events, which included intravenous (IV) fluids and pain medications. The clinical outcome of the events was recovered with sequelae on an unspecified date. Follow-up attempts have been completed and no further information is expected.
37 2021-04-18 lip swelling Facial tingling and lip swelling.
37 2021-04-18 bloodshot eyes Roughly 12hrs after receiving 2nd Pfizer Covid-19 dose I woke up with a stabbing headache, dizziness... Read more
Roughly 12hrs after receiving 2nd Pfizer Covid-19 dose I woke up with a stabbing headache, dizziness, lightheadedness, slight chills and bodyaches. As the day progressed I began to develop extreme bodyaches, extreme joint pain, I couldn?t regulate my body temperature which fluctuated between feeling very cold and very hot/feverish. My eyes were bloodshot from having a fever of 102.5 at it?s highest. I was in significant pain and unable to sleep and rest due to the severe bodyaches and joint pain in my hips, knees and wrists. I also had significant pain in my low back. I don?t have pain anywhere in my body generally. The dizziness and lightheadedness also continued to worsen to the degree that I couldn?t sit up or walk without losing balance. Around 11:30pm on Saturday 4/17, my fever broke and my aches and pains started to dissipate. As the aforementioned symptoms began to dissipate, I started having difficulty breathing. I felt as though I was having trouble breathing, specifically inhaling. I felt like I couldn?t catch my breath at times, though I was sitting or lying down and not exerting myself. I also developed wheezing and a mild cough, both of which have continued to worsen. Today is Monday 4/19/21 and I?m still having mild lightheadedness and dizziness, mild headache that feels like stabbing pains and my cough continues to worse as is the wheezing and feeling like I?m having difficulty breathing at times, without exertion. Injection site continues to be sore. My first dose, I had fatigue and injection site soreness, both of which were completely resolved as of 24hrs after being vaccinated.
37 2021-04-18 swollen tongue Tongue swelling (sensation) 45 in after vaccine injection with subjective throat tightness
37 2021-04-18 ringing in ears Chills, fever, muscle aches, starting 7 hours after injection, lasting on and off for the next 30 ho... Read more
Chills, fever, muscle aches, starting 7 hours after injection, lasting on and off for the next 30 hours. Horrible nausea starting 8 hours after injection and continuing on and off the following 24 hours. Mild versions of nausea and chills continuing through today (4/19/21), day 6. Day 4, headache, vertigo, dizziness, tinnitus. Tinnitus has not stopped since day 4.
37 2021-04-19 dry mouth, taste impairment There's a metallic taste in my mouth plus dryness in the mouth also that's causing bad breath which ... Read more
There's a metallic taste in my mouth plus dryness in the mouth also that's causing bad breath which is lasting for about a week now.
37 2021-04-19 mouth tingling, feeling of choking Pt reported small amount of tongue edema and tingling in mouth, throat, and lips. 25mg PO Benadryl g... Read more
Pt reported small amount of tongue edema and tingling in mouth, throat, and lips. 25mg PO Benadryl given.
37 2021-04-19 light flashes or floaters in the eye Flashing lights in peripheral of left eye for 20 minutes, tingling in right leg
37 2021-04-20 ear pain UTI Symptoms , like Blood in Urine with fever and Headache. Headache with ear pain and Nerve at ba... Read more
UTI Symptoms , like Blood in Urine with fever and Headache. Headache with ear pain and Nerve at back side of the ear swollen . Bell's Palsy to the right side of the face.
37 2021-04-20 painful gums, mouth ulceration, oral mucosal blistering Inflamed, sore gums Oral ulcer/blister with no history of cold sores Fatigue Fever Muscle aches
37 2021-04-20 lip swelling, mouth pain, swollen tongue, pain in jaw Mouth hurt very bad.; I was having an autoimmune reaction to the vaccine; I woke up and my lips abs ... Read more
Mouth hurt very bad.; I was having an autoimmune reaction to the vaccine; I woke up and my lips abs tongue were swollen; I woke up and my lips abs tongue were swollen; I could smile and it hurt to talk.; I went to ER because my throat was also starting to hurt; This is a spontaneous report from a contactable consumer (patient). A 37-year-old received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Mar2021 at 11:00 in left arm at single dose for COVID-19 immunisation (lot number was En6202). Medical history included Inflammatory bowel disease (IBD), chronic anemia, l5-s1 disc herniation, obesity, Gastrooesophageal reflux disease (GERD), migraine, known allergies: benzoyl peroxide and Cefalexin, mouth ulcers. Historical vaccine included first dose of received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Feb2021 at 11:00 in right arm at single dose for COVID-19 immunisation (lot_number En6203). The patient was not pregnant at the time of vaccination. Concomitant medications included chlorthalidone; budesonide; ferrous sulfate. The patient had 2-3 mouth ulcers already forming when she received 2nd shot; the patient had IBD and mouth ulcers often happen to her. On 21Mar2021, the patient woke up and her lips abs tongue were swollen. The patient could smile and it hurt to talk. Mouth hurt very bad. The patient went to ER because her throat was also starting to hurt and she was worried it would swell like her lips. ER doctor said the patient was having an autoimmune reaction to the vaccine on 21Mar2021 at 07:00. The patient was no treated for the events. The patient recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.
37 2021-04-20 mouth tingling Patient presented for second Pfizer covid vaccination today. She tolerated first vaccination well, ... Read more
Patient presented for second Pfizer covid vaccination today. She tolerated first vaccination well, however did note some hives on trunk 1 week later, which resolved with zyrtec. However, did have some residual erythema on chest at presentation today. I met with her before vaccination and given CDC recommendation to only discontinue vaccination series if evidence of allergic reaction within first 4 hours of vaccination, and patients motivation to complete series, we did proceed with second vaccination. Approximately 10 minutes after vaccination (11:30 am), she reported feeling hot and tingling in extremities and tongue. She did not feel short of breath, was able to drink water, but did report mild tightness of throat. Initial PE: She had increased erythema on chest, no redness or edema noted of face or tongue. No acute distress/increased work of breathing. Mild tachycardia, regular rhythm, lungs CTA bilaterally. Skin warm and dry, conversant and alert. Vitals initially HR 91, BP 121/85, O2 99%. Temp 97.2 F O2 sats remained 96-100 at all times. After 5 minutes, pt given 50 mg IM benedryl. Discussed having husband meet her to drive her home and to be with her this afternoon in case of worsening symptoms. After 15 minutes, BP 11/5/72, HR70 and O2 100%. She did begin to feel sleepy, but was able to ambulate to bathroom with assistance without difficulty. She felt her symptoms had resolved after 30 minutes and felt comfortable returning home with husband. She will continue benedryl 50 mg q 4-6 hrs for 24 hrs and allegra, which she had added recently for hives. They have strict instructions to seek medical attention with any change in condition. I will follow up with her tomorrow as well and then will also report to VAERS. 4/21/21 1:30 pm I spoke with Patient- she is doing very well today. She states she took an additional dose of benedryl before bed and allegra. This morning complete resolution, however where she had some hives in the last two weeks have flared and are itchy. I have asked her to sign up for vsafe and I will submit to VAERS as well. I also suggested she consider seeing an allergist if she has ongoing issue with hives.
37 2021-04-20 feeling of choking The patient's throat was tingling after administration, with not other side effects. Issue resolved... Read more
The patient's throat was tingling after administration, with not other side effects. Issue resolved on its own.
37 2021-04-20 thirst Shot at 12:20. 5-10 minutes later, pt reported feeling very dizzy even while seated. I had the pt si... Read more
Shot at 12:20. 5-10 minutes later, pt reported feeling very dizzy even while seated. I had the pt sit back down to see if the dizziness improved. She also said her heat was beating fast. She was thirsty and was given water. BP and HR were 172/117 and 94. She eventually began to shake a little and said she was cold. I had her lie down and put her feet on a chair to try to help with her dizziness but even then she said her symptoms weren't improving. I asked if pt would like me to call 911 and she agreed. They arrived and asked if she wanted to go the hospital and she agreed and left around 1:05. I administered no medication.
37 2021-04-20 ringing in ears Raging bilateral tinnitus; This is a spontaneous report from a contactable consumer (patient). A 37-... Read more
Raging bilateral tinnitus; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0150), via an unspecified route of administration administered in right arm on 31Mar2021 at 12:00 PM (at the age of 37-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took tetracycline and experienced allergies to it. On 01Apr2021 at 12:00 AM, the patient experienced raging bilateral tinnitus. The event was considered as serious as it was disabling/incapacitating. There was not treatment given for the event. Since the vaccination, the patient has been tested for COVID-19 (nasal swab, PCR) on 02Apr2021 which was negative. The patient had not yet recovered from the event.
37 2021-04-21 mouth tingling The patient had her vaccine at 8:21am. She reported her lips were tingly. At 8:48am , we gave 50mg o... Read more
The patient had her vaccine at 8:21am. She reported her lips were tingly. At 8:48am , we gave 50mg of benadryl. She reports history of allergy to shellfish. She takes Zyrtec 10mg daily. Her bp was 130/75. HR 71, RR 18, and oxygen 97%. Patient was no worse after benadryl and was ready to return to work. She was cautioned about driving after 50mg of benadryl.
37 2021-04-22 teeth hypersensitivity Tooth sensitivity that felt like spread through the gums. Lasted several hours. Bad enough to keep a... Read more
Tooth sensitivity that felt like spread through the gums. Lasted several hours. Bad enough to keep awake from sleep and consider going to a hospital. Laying down feels better than sitting or standing up. Tried oragel to numb the effected area. Did not alleviate pain. Did not try to treat otherwise.
37 2021-04-23 lip swelling Right side too Lip swelling, 2 hrs duration, onset 8hrs post vaccination. Right side Very mild face ... Read more
Right side too Lip swelling, 2 hrs duration, onset 8hrs post vaccination. Right side Very mild face swelling, resolved by the next day. Low grade fever, headache, nausea, chills, fatigue, body aches, onset 12-15hrs post vaccination. Fever and chills subsided within 12 hrs of onset. Fatigue, nausea, and headache ongoing but significantly improved 45hr after vaccination.
37 2021-04-23 mouth tingling Tongue started tingling 5 minutes after receiving shot and remained tingling for 2-3 hours. 1 hour a... Read more
Tongue started tingling 5 minutes after receiving shot and remained tingling for 2-3 hours. 1 hour after shot, had tight chest and some related coughing. 1-2 hours after shot, chest had burning sensation. All symptoms went away about 3-4 hours after shot.
37 2021-04-24 eye discharge Allergies where there were none before. Excessive sneezing, gunky eyes, running nose wheezing and co... Read more
Allergies where there were none before. Excessive sneezing, gunky eyes, running nose wheezing and coughing. Sinus congestion and strange pains in my head. The pains could not be fixed by Tylenol or congestion medication. The pains are sharp and tugging in a single spot. This started exactly 5 days after receiving the 2nd dose of Pfizer. The allergies are persistent. Nothing seems to work well. I tried benadryl and Claratin, but they failed. I also experienced unusual pain in the deep tissue of my left breast, like there was a swollen and painful lymphnode. The pain lasted for several days.
37 2021-04-24 eye itchiness I sneezed thousands of times during the day. I have a really itchy and runny nose. I couldn't sleep ... Read more
I sneezed thousands of times during the day. I have a really itchy and runny nose. I couldn't sleep at night because my nose is super itchy. I might also have itchy eyes. I never had any allergy in my life before having this vaccine.
37 2021-04-25 ear congestion Right after my first Pfizer shot I felt my left ear clog up and within 10 minutes the left side of m... Read more
Right after my first Pfizer shot I felt my left ear clog up and within 10 minutes the left side of my face from my cheek bone to my chin began to tingle and have a pins & needle feeling. It is 6 hours later and I still have this tingling on the left side of my face. It is not as intense as it was earlier but it is definitely still there. I called my Dr.?s office and they told me they had no reports of this and told me to report it here. In the past with food allergies I have had tingling in my arms but never like this. I was completely fine this morning and this was like within 5 minutes of my first dose I began to experience this. My Dr?s office said you may contact me which is fine. Hopefully this quits soon. Also what do I do for my next vaccine in 3 weeks?
37 2021-04-26 mouth numbness, lip swelling Swelling of the lips and numbness in the lips
37 2021-04-26 mouth ulceration I started to develop a ulter/redness spot inside of my month (lower lip), and it won't go away for o... Read more
I started to develop a ulter/redness spot inside of my month (lower lip), and it won't go away for over a month, it's not painful.
37 2021-04-27 oropharyngeal discomfort Patient recevied Pfizer vaccine and shortly after noticed her throat was scratchy and felt tight. S... Read more
Patient recevied Pfizer vaccine and shortly after noticed her throat was scratchy and felt tight. She was given 50 mg of benadryl PO with no relief. Was administered 0.3 mg of epineiphrine IM and called 911. EMS shortly arrived and transferred patient to nearest ED. Symptoms prior to leaving in stretcher were: diaphoresis, chest pressure, throat closing sensation, scratchy throat, "I don't feel right".
37 2021-04-27 tongue discolouration, dry mouth, tongue disorder, taste impairment, burning mouth syndrome, swollen tongue, tongue discomfort After shot, noticeable fatigue and hot / cold sweats sleeping first night. no other symptoms. 24-36 ... Read more
After shot, noticeable fatigue and hot / cold sweats sleeping first night. no other symptoms. 24-36 hrs later, dry mouth, weird taste in mouth, and very painful swelling, irritation, redness and "splits" on tongue. White spots near back of tongue and general discomfort. Went to Urgent Care on 4/16/21 (3 days after first vaccine dose) - because my normal Dr office could not see me for 2 weeks. Diagnosed with Oral Thrush and given meds.
37 2021-04-28 canker sore pain and heaviness in my arm, canker sore, rash on my face I had a shot 9;50 AM in the morning of S... Read more
pain and heaviness in my arm, canker sore, rash on my face I had a shot 9;50 AM in the morning of Sunday April 18th. I had no symptoms nor pains right after the shot. Later in the evening of that day, I started feeling pain in my left arm and felt that my arm was heavy. I felt like I could barely lift it. Next, I think it was around Wednesday, but I had a canker sore on the floor of my mouth. I usually take vitamin B supplements in order for me to not have canker sores in my mouth, so I'm guessing it was caused by the vaccine. Since Friday, I've started to having rash on my face. It started from right above my lip and has been spreading to both of my cheeks, eyes, and neck. This is my third time to have rash in my life. For the other two times, I think the reasons were stress, and not vaccination. I'm not allergic to anything.
37 2021-04-28 vision blurred Blood clots; Major blood loss; Blurred vision; Heart palpitations; Shortness of breath; Extreme fati... Read more
Blood clots; Major blood loss; Blurred vision; Heart palpitations; Shortness of breath; Extreme fatigue; Dizziness; This is a spontaneous report from a contactable other hcp (patient). This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 29Mar2021 12:00 (Lot number was not reported) as single dose (at 37 years old) for COVID-19 immunisation. Medical history none. There were no concomitant medications. On 31Mar2021 01:00, the patient experienced blood clots, major blood loss, blurred vision, heart palpitations, shortness of breath, extreme fatigue, dizziness. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events included blood transfusion, ongoing tests, ultrasounds. The events required a visit to the emergency room and a visit to the physician's office. Seriousness criteria of the events was reported as serious due to disability and life threatening. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No allergies. The patient was not pregnant at the time of vaccination. The information on the Lot / Batch number has been requested.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported events cannot be completely excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-04-29 burning mouth syndrome, mouth discomfort Tongue soreness initially and especially along the edges around 6:30 pm on 4/27/21, 4 hours after va... Read more
Tongue soreness initially and especially along the edges around 6:30 pm on 4/27/21, 4 hours after vaccination. Consistent non stop pain of tongue that only lessened around 6am on 4/29/21. Felt like it had been burned but had not eaten anything hot to cause. Glossitis. Realized evening of 4/28/21 sores were on the tip and bottom of the tongue. At 5am on 4/29/21 sores were more pronounced and pain was not getting better so went to urgent care that morning. Valtrex 1 gram tablet, 2 by mouth to be taken in am and pm, qty 4 were prescribed as well as magic mouthwash, 5 ml 4 times daily as needed. Took medications as prescribed. 4/29/21 6am, tongue finally only irritated and not full pain without using the mouth wash so seems to be getting better after treatment.
37 2021-04-29 smell distorsion hot flashes, heightened sense of smell to the point of nausea, lightheadedness
37 2021-04-29 swollen tongue Tongue swelling, Fatigue ,headache and heavy congestion cough
37 2021-04-30 eye disorder sleepy; tired; tested positive for covid-19 after receiving the first dose of the covid-19 vaccine; ... Read more
sleepy; tired; tested positive for covid-19 after receiving the first dose of the covid-19 vaccine; tested positive for covid-19 after receiving the first dose of the covid-19 vaccine; body ache; runny nose; left eye was throbbing; she couldn't swallow like her body forgot how to do it; feeling she had something in her throat; severe headache; tension on her neck that felt like a neck injury; neck pain; jaw was paralyzed; pain in arm; This is a spontaneous report from a contactable lactation registered nurse (patient). A 37-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number and expiration date unknown) via an unspecified route of administration on 06Jan2021 around 5 pm (at 37-year-old) at single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included amitriptyline since 2018 at 10 mg nightly, 20 mg and 30 mg for migraine and stopped after COVID, and she was feeling tired/ sleepy and that made it worse; riboflavin sodium phosphate (VITAMIN B), and magnesium. The next day on 07Jan2021 about 7:59 am (around 13 hours after receiving the vaccine), all of a sudden she was driving and her jaw was paralyzed, it's became hard, she couldn't move it and it was very painful. she never had that and she was driving with her two little kids and it freaked her out and she tried to park and she finally parked being it lasted for a couple of minutes. When she looked at the time again it was 8:03 am, it was gone. She needed to get her kids to safety because she was driving but then it went away. On 09Jan2021, she started to have all of a sudden this tension on her neck that felt like a neck injury, it was hard to move her neck to a certain side and started while she was working. It was progressing and she thought she hurt herself. The pain began to lead to a severe headache. The neck pain felt like an injury lasted for a couple of days, but headache persisted and was intense, it lasted for 2 weeks and her coworkers thought she had COVID. She worked on 09Jan2021 and 10Jan2021 and then called out after that. On 12Jan2021 and 13Jan2021 the pain was not just in her head but in the left eye, it was throbbing and severe pain deep inside. It lasted for a couple of days lasted for over a week, it was not as bad as the first couple of days, the pain was the most severe on the 12Jan2021 and 13Jan2021 and couldn't do anything and stayed in bed. It felt like it was nerve pain and she never had that before, it was definitely different. She took daily anti migraine medicine and as long as she took it she doesn't have migraine headaches. For her Sumatriptan 50 mg, she took it twice on 12Jan2021, but because of the side effects it makes her nauseous and she couldn't take it anymore, she just has the prescription. She was only allowed to have 10 a month. It is sumatriptan and it didn't work either and she was supposed to take it to reverse the headache and it didn't work. For the amitriptyline, its 10 mg and had to triple to 30 mg. She took it at nighttime, but one of the side effects is that it made her sleepy but she didn't sleep. She has a 3 month supply and had plenty, if she needed to adjust but that was her first time she was taking that much, her doctor said she could up her dose to 20 mg, her gave her permission before because it can be used at higher doses if needed, she did try the 20 mg but that did not work so she had to triple to 30 mg. Once she realized that was not helping she just said forget it. She had to triple the dose of her migraine medicine and she was taking 3000-4000 mg of paracetamol (TYLENOL) even that couldn't take it down and even did cold compresses. The headaches lasted for a couple of weeks and then she finally got COVID. The headache after that was different, not as intense, and even taking paracetamol a couple times per day was dealing with this headache, the fever the body aches. It is not like the headache she got from the vaccine. It lasted for another week with COVID and was different and managing the headache. So currently she was good. She stopped taking amitriptyline, she was taking it for 3 years and was switched to Vitamin B2 and magnesium in the last month and had no headaches. She had to switch after getting COVID because she felt more tired and sleepy and felt that the amitriptyline would make it worse so she had to find something else. She was good with the new medications. She was cleared to go back to work on 03Feb2021. She was pretty much good by 03Feb2021. She was told by her MD not to get a second dose but her employer stated she could be terminated if she was not fully vaccinated. She was concerned and scared of having this reaction again. Her arm pain hurt for a few hours but because she has other pain she thought it was her left arm but she really couldn't recall. she did have pain in her arm, it was normal pain nothing significant. It started at 11 pm on 06Jan2021 and lasted until Saturday 09Jan2021 and remembered that she had a hard time helping at work because she has to used the arm but the arm soreness was just like with any other vaccine, nothing abnormal. From 10Jan2021 to 13Jan2021 she kept feeling she like had something in her throat in the morning, and when she would start drinking she couldn't swallow like her body forgot how to do it. She would hold it in her mouth and then 30 seconds later she would start swallowing and then it went away. It was just in the morning for like 4 days. It cleared by 14Jan2021, clarifies it ended then. Caller stated her husband took a test on 11Jan2021 and didn't get his results until 14Jan2021 and showed he was positive and he was already isolating and she was at home with the kids. States her husband was the one that brought it in. She did start to have COVID symptoms until 23Jan2021, she had fever, chills, body ache, runny nose, shortness of breath and diarrhea. She was prescribed a z pack, azithromycin, and it helped with cough, the congestive cough and nasal spray for her runny nose. It was water coming out of her nose, most runny she has ever felt. She got testing and kept going for testing because she felt so sick and it was negative (on 13Jan2021 and 18Jan2021). She finally tested positive on 25Jan2021. No additional therapies for COVID-19. No other test performed, they see patients that keep testing positive 3 months later after no symptoms and just want to wait for symptoms to go down. The patient was not hospitalized, not admitted to an Intensive Care Unit. The outcome of the event paralyzed jaw was resolved on 07Jan2021, neck pain/ tension was resolved on 11Jan2021, headache was resolved on 03Feb2021, throbbing eye was resolved on 19Jan2021, pain in arm was resolved on 09Jan2021, "feeling she had something in her throat" and swallowing impaired was resolved on 14Jan2021, of other events were unknown. Reporter seriousness for Jaw was paralyzed: unknown Reporter seriousness for headache: serious, affected her ability to perform and no one wanted to see her in person and only had virtual visits with the doctor Reporter seriousness for tested positive for COVID-19 after receiving the first dose of the COVID-19 vaccine: Unspecified Reporter seriousness for tension on her neck that felt like a neck injury: Not serious Reporter seriousness for left eye was throbbing: Medically significant Reporter seriousness for pain in arm: Not serious Reporter seriousness for feeling she had something in her throat: Not serious The primary reporter considered the events paralyzed jaw, neck pain, headache, throbbing eye, pain in arm, "feeling she had something in her throat" were related to BNT162B2; while event tested positive for COVID-19 was unrelated. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events
37 2021-05-01 oropharyngeal discomfort Patient complained of throat discomfort/swelling.
37 2021-05-02 loss of smell, loss of taste Fatigue, Muscle or body aches, Headaches, New loss of taste or smell, Congestion or runny nose and D... Read more
Fatigue, Muscle or body aches, Headaches, New loss of taste or smell, Congestion or runny nose and Diarrhea, chills, heaviness in chest at times
37 2021-05-02 ear discomfort, eye discomfort - immediately after vaccine -- redness in face, heaviness in arms and legs. nurse gave me Zyrtec and... Read more
- immediately after vaccine -- redness in face, heaviness in arms and legs. nurse gave me Zyrtec and I was ok after 45 min - evening of shot -- typical flu response, felt sick, by next day had 103 degree fever - day after shot afternoon -- developed swelling sensation in throat, hard to swallow. Took another Zyrtec and it went down a bit. - headache persisted throughout week after shot on left side of head - day 9 after shot headache got extremely bad, throbbing pain in head on left side, electric jolts through head - day 10 took excederin migraine to relieve headache pain, made head throb and pulse and face went numb on left side and left arm numb - bad headache continued day 9 - day 13 after shot, mostly on left side of head - also developed spasm in chest at night mostly when lying down, feels like a motor running that sometimes turns off (still happening at 3 weeks) - day 14 after shot headache continued, now on both sides all day long, pressure behind earns, sometimes behind eyes, top of head - day 18 morning took Advil to relieve headache pain, developed numbness in face and difficulty swallowing - current (almost 3 weeks after shot) still have headache, afraid to take pain meds, seeing neurologist in a week
37 2021-05-02 mouth numbness Numbness on left side of tongue within 4 minutes of receiving vaccine. Transient Dizziness and short... Read more
Numbness on left side of tongue within 4 minutes of receiving vaccine. Transient Dizziness and shortness of breath 2 hours later. Fatigue 3-10 hours later. Severe joint pain in hands about 8-12 hours later. Transient. Pain and stiffness in hands and feet/Achilles tendons 36 hours later. Transient. Reduced sensation and feeling of heaviness, puffiness on left side of face 40 hours later. Unknown duration.
37 2021-05-03 mouth tingling Had left facial numbness and tingling, tingling of my tongue, dizziness
37 2021-05-03 mouth tingling Patient came to registration table and said tongue initially felt fat and tingly but was having no t... Read more
Patient came to registration table and said tongue initially felt fat and tingly but was having no trouble breathing. States she felt weird and was directed to sit in front row of chairs to observe and let us know if symptoms worsened or persisted. As patient continued to be monitored she states she was becoming immediately fatigued and just wanted to take a nap and felt very weak. Rapid response team was called to take patient to ER to be evaluated further.
37 2021-05-03 taste disorder 2:10pm, after receiving the injection, patient felt dizzy upon standing. Gave her a tangerine and w... Read more
2:10pm, after receiving the injection, patient felt dizzy upon standing. Gave her a tangerine and water. Sat down and felt hot, naseous, tightness inside body. 2:45 headache behind left eye and mouth tastes like medicine. BP 150/80, O2 100%, HR64 RR28. After an hour of resting, laying down, meditating, patient felt a little better, but still bad. BP120/72, O2 100%, HR 88. Patient left with a friend at 3:35.
37 2021-05-04 ear discomfort, ringing in ears, ear pain Sinus/ear pressure and ear discomfort/pain. 2 short mild instances of tinnitus. Each lasted about 5 ... Read more
Sinus/ear pressure and ear discomfort/pain. 2 short mild instances of tinnitus. Each lasted about 5 seconds then went away. One was in left ear, one in right. Head and ear pressure have gotten much better since first onset, but still comes and goes, not totally resolved.
37 2021-05-04 lip swelling, eye swelling Severe Hives; Severe swelling on eye and lip; Severe swelling on eye and lip; severe swelling arthri... Read more
Severe Hives; Severe swelling on eye and lip; Severe swelling on eye and lip; severe swelling arthritic feeling in hands; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ENS318) via unspecified route administered in Arm Left on 26Jan2021 09:30 via an unspecified route of administration, as single dose for an unspecified indication. Historical vaccine included first dose of bnt162b2. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol (VITAMIN D COLECALCIFEROL). No other medication taken four weeks prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test with unknown date. The patient experienced severe hives on, severe swelling on eye, severe swelling on lip, Started roughly 10 hours after the vaccine and are still lasting 4 days later. Also severe swelling arthritic feeling in hands(could not grip anything on day 2) all these on 26Jan2021 19:00. The patient was currently using prednisone, Zyrtec, benedryl, and Pepcid AC and said nothing was helping. The patient said she had no known allergies and have never had hives before. She had to miss two days of work. The outcome of the event was not resolved. Follow-up (02Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Query: Dear Manufacturer, Kindly see the attached document received by Pfizer Inc. containing a product in which you have been identified as the manufacturer. Response: Email received. Case created #. Dear Colleagues, Would you kindly address the query below and copy it to the mailbox with your reply.
37 2021-05-04 lip swelling Patient is a 37 yo female new patient referred by the ED for allergy consult on delayed urticarial/a... Read more
Patient is a 37 yo female new patient referred by the ED for allergy consult on delayed urticarial/angioedema 2 days following the initial dose of Pfizer Covid19 vaccination. Timeline: 4/19/21 Received her first Pfizer immunization at clinic. 4/21/21: She woke up with a systemic itchy rash. Worst in flexural regions like the folds of her groin, elbows, knees and where her bra meets her skin. The hives didn't stay fixed and didn't respond to benadryl. She also was experiencing joint pain in her hands and ankles. 4/23/21: Increased benadryl dose to 50 milligram Q4 hours which initially helped but then the hives returned. 4/27/21: Seen at a local urgent care and was prescribed a medrol dosepak. She didn't fill this immediately given pharmacy wait time. 4/28/21: Woke up with upper lip swelling. Went back to urgent care and was given epinephrine which didn't help. She was referred to the ED where she was given an IV, IV benadryl and more epinephrine. Tryptase was not obtained. At no time did she have dizziness, throat swelling, or difficulty breathing. Her lip swelling resolved and she was discharged home. Her blood pressure and respiratory exam in the ED were normal. She continues to have itching and rare hives. She is currently on day 3 of the medrol dosepak and is taking benadryl 50 mg. Q6H She denies a history of medication/vaccine allergies/reactions. She had recent IVF retrieval on 3/29 and is currently taking birth control pills for ovarian suppression.
37 2021-05-04 bloodshot eyes, eye swelling 4/24 midnight: muscle pain and joint pain 4/26 recovered from the pain 4/25 Started to have rashes o... Read more
4/24 midnight: muscle pain and joint pain 4/26 recovered from the pain 4/25 Started to have rashes on the face, side of nose then inside the nose, then around the eyes 5/2 Swollen eyes got worse each morning after 5/2 5/4 Went to urgent care and later ER, because of red eyes, shingles liked symptoms around both eyes (eye lids) and numbness on the left side of the face. Got prescription for valacyclovir and ganciclovir ophthalmic gel. 5/5 Eyes are still swollen but not worse compare to the day before. Some joint pain still persists (left hand)
37 2021-05-04 bloodshot eyes, swelling of eyelid, lacrimation increased Pfizer-BioNtech COVID-19 Vaccine swollen eyelids both upper and lower of the eye, severe pain, wat... Read more
Pfizer-BioNtech COVID-19 Vaccine swollen eyelids both upper and lower of the eye, severe pain, watery eyes , redness in the eye and pus discharge. Currently being treated with painkillers and antibiotics
37 2021-05-04 mouth tingling, swollen tongue Patient presents with a rash that started after her 2nd covid immunization ( Pfizer ). Her first imm... Read more
Patient presents with a rash that started after her 2nd covid immunization ( Pfizer ). Her first immunization was placed on 3/29/2021 and her 2nd was placed 4/19/2021. approximately 4 hours after her 2nd immunization she developed a warm sensation to her hands and they felt hot. She ran them under water but the warm water was painful. The symptoms did move to her feet as well so she went to the ER and was told she had an allergic reaction and was prescribed benadryl, pepcid and told if she did et any steroids her 2nd immunization would no be effective so she elected to not get any steroids and presents today for follow up care. No shortness of breath but did feel her tongue was bigger and tingling - today her tongue feels normal , no Hives or rash but her fingers tips did peel.
37 2021-05-04 ringing in ears Severe pulsatile tinnitus, tingling and electric feelings in feet, unusual headaches
37 2021-05-05 taste impairment About 9 minutes after administration, pt reported a nickel taste. Initially strong, but it was subsi... Read more
About 9 minutes after administration, pt reported a nickel taste. Initially strong, but it was subsiding by 15 minutes after the vaccination
37 2021-05-05 mouth tingling Tingling of tongue and lips and tightness in throat within 15 minutes; advised by ED physician not t... Read more
Tingling of tongue and lips and tightness in throat within 15 minutes; advised by ED physician not to follow up for 2nd dose.
37 2021-05-06 ear discomfort, ringing in ears Clogged ear feeling and ringing in ears
37 2021-05-06 swollen tongue Tongue started swelling while driving home so I drank water. Pulled over and took liquid children?s... Read more
Tongue started swelling while driving home so I drank water. Pulled over and took liquid children?s Benadryl. It didn?t really reduce it but I was having no trouble breathing.. Woke up the next morning with swelling almost gone.
37 2021-05-06 taste disorder, smell distorsion, loss of smell, loss of taste I lost my sense of smell and taste entirely. Now it comes and goes but everything smells rancid and ... Read more
I lost my sense of smell and taste entirely. Now it comes and goes but everything smells rancid and horrible
37 2021-05-06 ringing in ears rash and ringing in the ear treated with benadryl 50mg . the treatment was for couple of days and he... Read more
rash and ringing in the ear treated with benadryl 50mg . the treatment was for couple of days and helped improve symptoms of rash but for ringing in ear only slightly improved
37 2021-05-08 loss of smell, lacrimation increased, deafness Headache, bone pain/ache, tiredness, watery eyes, runny nose, lack of smell, very congested that an... Read more
Headache, bone pain/ache, tiredness, watery eyes, runny nose, lack of smell, very congested that and I can barely hear. Going on day 3 with these symptoms no fever.
37 2021-05-09 eye strain Shivering, chills, fever, bodyache, energy less. Headache, heaviness in eyes and head. On May 8th 11... Read more
Shivering, chills, fever, bodyache, energy less. Headache, heaviness in eyes and head. On May 8th 11:50 I got 2nd dose of Vaccination, after that normal tenderness at site, but near 8:00 pm felt uncomfortable, around 11 pm shivering, fever. 9th May stayed on bed, felt energy less, bodyache. Today feeling better, but still feel heaviness in head and eyes, not normal feeling, took day off from work.
37 2021-05-10 eye strain Headache; Back Pain; muscular weariness; Tired eyes; feel strange as sick; This is a spontaneous rep... Read more
Headache; Back Pain; muscular weariness; Tired eyes; feel strange as sick; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (Pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 10Apr2021 at 08:45 AM (lot number: EW0150) at single dose for COVID-19 immunization. The relevant medical history was reported as none. Concomitant medications were not reported. On 17Apr2021 at 17:00, the patient had headache, back pain, muscular weariness, tired eyes. She felt strange as sick. It's been almost two weeks since she got the vaccine but only on Saturday she started with a headache. When she empused herself she was in pain head for two days but they became all the symptoms together a week after. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were reported as non-serious. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
37 2021-05-10 ringing in ears, ear pain Tingly feeling on her left face; A ring sound on her left ear and pain as well; A ring sound on her ... Read more
Tingly feeling on her left face; A ring sound on her left ear and pain as well; A ring sound on her left ear and pain as well; Pain in the injection area; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 01Apr2021 (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that she had a reaction after the 1st dose of the vaccine last 01Apr2021, pain in the injection area, tingly feeling on her left face, a ring sound on her left ear and pain as well. Now, she wants to know more about her reaction and if it is safe for her to get the 2nd dose of the vaccine on 22Apr2021. It is reported that she received the first dose of the Pfizer-BioNtech CoVid-19 vaccine on 01Apr2021, immediately after getting the shot, the left side of her face started tingling and it lasted for a couple hours. A couple days later her left ear started hurting and the pain has not gone away, she has like a ringing in her ear, her right ear is also experiencing some. Caller states she found that some people has even lost their hearing. She would like to know if she should procced with the second dose of the vaccine and if the ear problems are permanent and if the second dose of the vaccine will make the side-effects worse and if she should delay a couple weeks the second dose if that helps. The outcome of the event tingly feeling on her left face was recovered in Apr2021, the outcome of the event ear pain was not recovered, outcome of the remain events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
37 2021-05-12 eye swelling developed shingles. It began on my scalp and then traveled down my forehead and into my eye; develop... Read more
developed shingles. It began on my scalp and then traveled down my forehead and into my eye; developed shingles. It began on my scalp and then traveled down my forehead and into my eye; My eye became so swollen, it shut completely; fatigue; aches/ soreness; chills; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9267) dose 1, via an unspecified route of administration, administered on the left arm on 15Feb2021 05:00 AM as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 (prior vaccination), ulcerative Colitis and known allergies red food coloring. Concomitant medications included infliximab (INFLECTRA), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); zinc and ergocalciferol (VITAMIN D). Upon receiving the vaccine, the patient initially had a typical reaction including soreness, fatigue, aches, and chills (Feb2021). On 19Feb2021 07:00 AM, patient developed shingles. It began on her scalp and then traveled down her forehead and into her eye. This was all on the left side of her scalp and face (the vaccine was given on my left side). Her eye became so swollen, it shut completely. She visited both the ER and urgent care as well as an ophthalmologist. She is now 12 days post vaccine and she still have shingles and extreme swelling of left eye. Currently taking Valtrex, oral steroids, steroid eyedrops, and using antibiotic ointment on her eye. The events resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the events which included Valtrex, steroids, antibacterial ointment. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events fatigue, aches/ soreness and chills was unknown and not recovered for the other events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event Ophthalmic Herpes zoster with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
37 2021-05-12 pain in jaw, toothache Shingles. Diagnosed on 5/8. Symptoms include fatigue, severe headache, tooth pain, jaw pain, scalp s... Read more
Shingles. Diagnosed on 5/8. Symptoms include fatigue, severe headache, tooth pain, jaw pain, scalp sensitivity, sores around mouth/chin/cheek/sideburn area.
37 2021-05-12 sudden hearing loss, deafness 32 weeks pregnant at time of vaccination On the next day following vaccination, noticed sudden heari... Read more
32 weeks pregnant at time of vaccination On the next day following vaccination, noticed sudden hearing loss in right ear. Will start steroid treatment. MRI not yet performed.
37 2021-05-12 taste disorder, taste impairment Metallic and rancid taste, sour throat and runny nose . Sore throat and runny nose lasted for 2 da... Read more
Metallic and rancid taste, sour throat and runny nose . Sore throat and runny nose lasted for 2 days. Change in taste still present weeks after.
37 2021-05-13 eye pain, vision blurred, ringing in ears, ear pain, ear discomfort, eye strain Starting one day after the shot I experienced the following reactions which came and went intermitte... Read more
Starting one day after the shot I experienced the following reactions which came and went intermittently for three weeks: -heart palpitations -numbness in hands -tingling and shakiness in arms and legs -severe pressure headaches -Difficulty focusing eyes, eye pain/strain -ear pain/pressure -dizziness and confusion -tinnitis
37 2021-05-13 ringing in ears, extreme sound sensitivity As reported in the first dose: Symptoms appeared three days after second dose. I mainly have hissing... Read more
As reported in the first dose: Symptoms appeared three days after second dose. I mainly have hissing perceived in my right ear, sometimes left ear, and sometimes in the middle of my head. The tone sometimes changes from hissing to a slight hum in both ears (like a faraway vacuum sound). After the second dose, I notice the humming sound is more prominent in my right ear, especially when I wear ear buds without accompanying music (such as wearing them when engaging in a phone conversation with someone). Similar to the first dose, I get sudden spikes of my tinnitus that come out of nowhere but subside within a few seconds. The tinnitus is more prominent when in a silent room (such as sleeping at night), climbing the stairs, running, and after taking a shower. It sometimes gets worse if I am around loud noise. I visited my primary care doctor for a routine physical exam on 5/7/21 and she didn't seem too concerned. She said there are many reasons for tinnitus and sometimes we don't know why it begins and I might not likely find a reason. She said she will refer me to an ENT if symptoms get worse or if I notice accompanying hearing loss. I also do want to note I noticed hyperacusis (sensitivity to loud noise) approximately a week after my frst dose. That does seemed to have resolved itself just before the second dose (so it lasted about 2 weeks). I have not noticed hyperacusis after my second dose.
37 2021-05-13 ringing in ears Tinnitus (hissing in ears) started three days after vaccination. Subsided slightly before second dos... Read more
Tinnitus (hissing in ears) started three days after vaccination. Subsided slightly before second dose (5/3) but symptom still persists. Tinnitus is mainly in right ear with some sound perceived in left ear. Sometimes it switches ears or is in the middle of my head. Tone sometimes changes from a hiss to a slight hum (like the distant sound of a vacuum in the background). I also have sudden spikes that come out of nowhere but subside after a few seconds. Tinnitus is more noticeable in a silent room (sleeping at night), when wearing ear buds (with no music on, such as engaging in a phone conversation with someone), climbing the stairs, running, and after taking a shower.
37 2021-05-15 swollen tongue On both shots, within 24 hours I had full bodyaches and my body temp dropped to 96.1. I had chills e... Read more
On both shots, within 24 hours I had full bodyaches and my body temp dropped to 96.1. I had chills every time I drank anything. Lasted 24 hours both times. After the 1st shot I had horrible muscle cramps for 2.5 weeks. After the 2nd shot, within 5 days the tastebuds on the back of my tongue got swollen and I feel like I've burnt my tongue on the back and sides of my tongue, but I haven't. Brushing my teeth and using mouthwash twice a day has not helped, neither has warm salt water rinses. My tongue also feels slightly swollen so I have been taking anti-inflamatories.
37 2021-05-16 vision blurred, eye floaters, eye pain Eye pain started day of vaccination 2/3/21. Floaters and blurry vision started evening of vaccinatio... Read more
Eye pain started day of vaccination 2/3/21. Floaters and blurry vision started evening of vaccination/next morning. Triggered an autoimmune disease called Birdshot Uveitis- diagnosed 2/8/21.
37 2021-05-17 loss of taste, loss of smell Received Pfizer-BioNet COVID-19 vaccine on 3/30/2021 and 4/22/2021. On 5/9/2021 patient developed s... Read more
Received Pfizer-BioNet COVID-19 vaccine on 3/30/2021 and 4/22/2021. On 5/9/2021 patient developed shortness of breath and loss of taste/smell. Tested positive for COVID. Treated with bamlanivimab/etesevimab.
37 2021-05-18 dry throat Pt received shot at 10:49 am. She had warned us of a history to anaphylaxis with penicillin and ceph... Read more
Pt received shot at 10:49 am. She had warned us of a history to anaphylaxis with penicillin and cephalosporins and we counseled her to be observed for 30 minutes at the pharmacy. Between 10 and 15 minutes after her immunization she had a panicked look on her face and said her throat felt extremely dry and scratchy. We immediately called 911 due to the history of anaphylaxis and they instructed us to not let her have any water to drink. She continued to be alert and breathing/talking through the entire episode and never had any other complaints besides extremely dry mouth, sore throat, and scratchy voice. The paramedics arrived approximately 20-25 minutes after the immunization and observed her in the pharmacy for approximately 5 minutes. They then walked with her to the ambulance where she just sat and talked to them for another 10 minutes and they cleared her to drive home. No medications were administered. A couple hours later I spoke to the patient and she said her throat was still a little sore and dry but nothing else had happened.
37 2021-05-19 deafness I developed (possible) sudden sensorineural hearing loss 2 weeks after my second dose of COVID-19 va... Read more
I developed (possible) sudden sensorineural hearing loss 2 weeks after my second dose of COVID-19 vaccine on May 19, 2021. I started to experience a change of my hearing (reduced hearing) in the morning of May 19, 2021 in the left ear. No vertigo or dizziness, no fever, no discharge. The diagnosis is made by Dr. on May 20 2021. For completeness, I had a medical history of Guillain-Barre Syndrome in 2002, and Bell's Palsy in 2010. Both were mild cases and recovered with no sequela. I never took Flu shot because of the medical history. I am glad that I took the COVID-19 vaccine because I think it would be worse if this is a natural infection. It might be valuable if we can collect safety data for those who had GBS history, so people know what to expect and they can be proactive if things happen.
37 2021-05-20 deafness 4 days after each dose of series started having vestibular symptoms. First dose resulted in disequil... Read more
4 days after each dose of series started having vestibular symptoms. First dose resulted in disequilibrium that was positional (up and down movements of the head) at first and the progressed to persistent the next day and ended with a migraine headache that night. Better during the weekend and then took about 2 weeks to resolve. Had almost fully resolved (would still return with ingestion of antihistamine so had to stop taking it) but then got second dose and was initially ok, but 4 days after dose started having rotator vertigo L sided. Vertigo and disequilibrium were never symptoms of known schwanomma. The schwanomma is small 3mm and intralabyrinthine. Negligible hearing loss at baseline of 25 dB at 4000 Hz. Both ENT physicians acknowledge temporal link but agree hard to tell because vaccine is so new and hard to conclude causation and none of the routine evaluation for the schwanomma fit the clinical picture.
37 2021-05-20 mouth swelling, eye swelling, swollen tongue Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient fel... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient felt tongue swell and face felt itchy and numb. Patient was conscious, talking and able to swallow water. Gave her 25 mg of benadryl. Called 911, medics transported to hospital. Patient called and said hospital gave her more benadryl and steroids.
37 2021-05-20 visual impairment Client received the COVID vaccine (Pfizer dose 1, lot #EW0185, expiration date5/2/2021) at 1536 in ... Read more
Client received the COVID vaccine (Pfizer dose 1, lot #EW0185, expiration date5/2/2021) at 1536 in her left arm. The client reported "my heart is going fast and slow" and 1550. EMTs, and RN responded at that time. The client endorsed "pressure" in her chest nausea, and some shortness of breath. The client's vital signs were as follows: heart rate 110, O2 99%, respiratory rate 20, blood pressure 138/118. The client's skin was pink, warm, and dry, and she was alert and oriented. The client stated her shortness of breath was getting worse and 911 was called at 1554. Per the client, she has no history of needle anxiety or syncope. She stated that she did eat lunch prior to getting her vaccine. The client stated that she has a medical history of SVT (supraventricular tachycardia) and she does take medication for it but she did not remember the name ("it sounds like lisinopril", "it works like a beta blocker") and she hadn't taken the medication today. The client has an allergy to morphine. At 1556, the client's vital signs were as follows: heart rate 116, blood pressure 128/palpable, and O2 98. The client stated they don't have a previous history of anxiety. The client was observed to be sitting forward in their chair, with increased work of breathing, and visible diaphoresis. The client stated they had a sudden onset headache and rated the pain 6/10. The client stated they have no history of migraines and have "never had a headache like this before." The client dry heaved repeatedly and complained of persistent nausea, as well as "twisting" pain in her left axilla. The client's pulse was bounding and she endorsed changes in her vision. Pupils were equal and reactive to light. The client continued to be alert and oriented, but very anxious. She was able to demonstrate equal strength in hand grips. AMR arrived and assumed care at 1600. Client transported to Hospital at 1607.
37 2021-05-23 eye twitching My left eye started twitching 5/20 a couple hours after I received my 2nd COVID vaccine. It's been s... Read more
My left eye started twitching 5/20 a couple hours after I received my 2nd COVID vaccine. It's been several days and my eye is still twitching. Sometimes it twitches several times an hour and sometimes I go a few hours without twitching. No other symptoms and only my right eye has the twitch. I do not have a history of eye twitching.
37 2021-05-23 ear pain Sore throat, rapid heart rate, uneven heart rate, exhaustion, bad headache, increased sensitivity to... Read more
Sore throat, rapid heart rate, uneven heart rate, exhaustion, bad headache, increased sensitivity to heat - all eventually diagnosed as hyperthyroidism. Also extreme inner ear pain - not yet diagnosed. All started about 5 days after 1st COVID vaccine. Diagnosis of hyperthyroidism happened about two months later (5/18/2021) when I finally went into an ER.
37 2021-05-24 loss of smell, taste impairment Received Pfizer COVID vaccines per report on 12/26/20 and 1/16/21. Tested positive for COVID-19 by P... Read more
Received Pfizer COVID vaccines per report on 12/26/20 and 1/16/21. Tested positive for COVID-19 by PCR on 5/24/20. Unknown symptom onset date; had anosmia, dysgeusia.
37 2021-05-24 eye pain Like 5-10 mins after receiving the vaccine I began to have right temporal pain. This stayed for 2-3 ... Read more
Like 5-10 mins after receiving the vaccine I began to have right temporal pain. This stayed for 2-3 hours. The pain then started to creep over my right eye and then my entire right face. Within the next 4-5 hours I was having pain over both eyes. By midnight I woke up with pain at the right backside of my head along with chills and body aches. The headache lasted for 2 weeks. I called my Dr. after 1 week. He prescribed prednizone 40mg which did not work. He then prescribed 600mg Advil every 4-6 hours which also did not work. Then imotrex which also didn't help. Also, the last 3/4 days, I had increased jaw tightness. I usually have TMJ issues but this was extraordinary. Eventually the symptoms resolved themselves.
37 2021-05-24 lip pain, mouth numbness Maybe 5 minutes after the shot I noticed a headache, then about 25 minutes after the shot, my face s... Read more
Maybe 5 minutes after the shot I noticed a headache, then about 25 minutes after the shot, my face started to swell a bit around my mouth and I had some pain. My sinuses and breathing passages swelled. The swelling went down gradually within 24 hours or so, but since then my lips and the area surrounding them have remained numb and it hasn't gone away. Hurts a bit to smile. I kept waiting for it to end so I could report what happened as far as duration, but it hasn't ended. I'm slightly angry about this and also recognize it is what it is. I regret getting this vaccine for sure though knowing it was a rushed process! I called my doctor today and have an appointment next week to discuss my allergies and reactions in general. Other reactions that happened but not sure if they are related -- intense, long lasting menstrual cramps post shot (just way more than usual) and blood for several days in my bowl movements. Those two items have subsided.
37 2021-05-25 dry throat Extreme itching all over head and arms; Chills, with uncontrollable shaking; Chills, with uncontroll... Read more
Extreme itching all over head and arms; Chills, with uncontrollable shaking; Chills, with uncontrollable shaking; Cannot get rid of dryness in throat; Hands and feet are frozen; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0168; Expiration Date: 31Aug2021) via an unspecified route of administration on 10May2021 at 07:40 (at the age of 37-years-old) as a single dose for COVID-19 immunisation (to protect self and kids). Medical history included shingles in left eye from an unspecified date (diagnosed two weeks ago) and unspecified if ongoing. The patient had no history of previous immunizations and had no history of adverse events that followed prior vaccinations. Family medical history was reported as none. Concomitant medications included moxifloxacin (eye drops; strength: 0.5%; Lot Number: AGT001; Expiration Date: Jun2023) ophthalmic taken for shingles in left eye from an unspecified date (started two weeks ago) to an unspecified date (stopped a week ago per doctor's instructions) at 1 drop (in left eye), 4x/day; prednisone (eye drops; strength: 1%; Lot Number: E90450; Expiration Date: Aug2023) ophthalmic taken for shingles in left eye from an unspecified date (started two weeks ago) and ongoing at 1 drop (in left eye), 4x/day and acyclovir (ACICLOVIR) orally taken for shingles in left eye from an unspecified date (been on it for two weeks) to an unspecified date (did not take it today) at 200mg, 5x/day. The patient did not receive any additional vaccines on the same date as the COVID-19 vaccine or within 4 weeks of the COVID-19 vaccine. On 10May2021 the patient experienced extreme itching all over head and arms, chills, with uncontrollable shaking, cannot get rid of dryness in throat and hands and feet are frozen. The clinical course was reported as follows: The patient received the first dose this morning. She waited the recommended fifteen minutes and was fine. While she was driving home, she started to feel extreme itching all over arms and head. She made sure that she did not have a rash. She had to take care of her son that got injured and take him to the pediatrician. The patient's throat did not close, but she cannot get rid of the dryness. She had been drinking and drinking, but her throat was extremely dry. Her son's pediatrician advised her to take Benadryl, so she took 2 teaspoons, but was still experiencing uncontrollable shaking, chills, throat dryness, extreme itching on arms and head, and hand and feet were frozen. She had chills with uncontrollable shaking. She stated that it was uncontrollable, she was shaking uncontrollably. She did not have a fever. She was aware that chills were a known side effect. She asked whether dryness of the throat was common. She could not get rid of the dryness in her throat. It was not getting better. She clarified that she was not having breathing issues. The extreme itching was all over her had and arms, it would get better, start, and stop. She was not allergic to anything. The patient stated that she had the COVID vaccine scheduled for two weeks ago and then cancelled the appointment. Her doctor said there was no reason to cancel the COVID vaccine appointment because there would be no interaction between the drugs and the COVID vaccine. She did not take Acyclovir today. She was supposed to go for a follow-up appointment today, but she canceled it. The adverse events required a call to her primary care physician. The adverse events did not require a visit to the emergency room. Relevant tests were reported as none. The clinical outcomes of the events extreme itching all over head and arms, chills, with uncontrollable shaking, cannot get rid of dryness in throat and hands and feet are frozen were not recovered/not resolved. Follow-up attempts are completed. No further information is expected.
37 2021-05-25 eye pain I experienced a variety of symptoms including darkened veins, head pressure and headache, tingling/ ... Read more
I experienced a variety of symptoms including darkened veins, head pressure and headache, tingling/ numbness in bottom left half of face, heart palpitations and chest tightness, sleepy/ restless legs, and a bruised/ sore left orbital the morning after the shot. The heart palpitations occurred on the 4th day after the vaccination. Most symptoms persisted over the course of three weeks.
37 2021-05-25 tongue itchiness, mouth itchiness, mouth tingling Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: faci... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Slight tingle/itch of the oral cavity/tongue 1.5 hours following administration.
37 2021-05-26 pain in jaw About 4 days after the vaccine, suddenly in the middle of the day, I had jaw pain in my left jaw. th... Read more
About 4 days after the vaccine, suddenly in the middle of the day, I had jaw pain in my left jaw. there is a lot of tightness and I can't open my mouth wide. exactly one week after the vaccine I had a possible TIA. I was observed and underwent testing for a day and a half at the medical center.
37 2021-05-27 dry mouth Pt c/o slight SOB, dry mouth, dizziness after 2nd dose of Pfizer. RN & NP assessed VS (BP 147/87; HR... Read more
Pt c/o slight SOB, dry mouth, dizziness after 2nd dose of Pfizer. RN & NP assessed VS (BP 147/87; HR 114, AOx4) afebrile, no SOB or trouble swallowing. Pt has history of anemia & taking iron supplements. Pt felt similar after 1st dose. RN & NP reassessed vital signs (BP 127/79; HR 99). Pt denied SOB, verbalized sx resolution. D/C to home with steady gait
37 2021-05-27 mouth numbness 2 hours after vaccine my entire face and teeth went numb and tingly like pins and needles and my thr... Read more
2 hours after vaccine my entire face and teeth went numb and tingly like pins and needles and my throat felt slightly swollen. I took a benadryl which did help some with my face and throat but my teeth still felt numb and tingly. The next day I felt a bit better my whole face still had a slight numbing sensation but not bad. By friday I felt mostly back to normal.
37 2021-05-28 ear discomfort Swollen lymph nodes/tender neck and lower face; Swollen lymph nodes/tender neck and lower face; Swol... Read more
Swollen lymph nodes/tender neck and lower face; Swollen lymph nodes/tender neck and lower face; Swollen lymph nodes/tender neck and lower face; pressure on left ear; Headache; pain in upper right abdomen; arm pain; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 via an unspecified route of administration administered in left arm on 24Feb2021 10:00 (at 37 years old) as single dose for COVID-19 immunization. Medical history included appendix removed, gallbladder removed, heartburn, and known allergies to adhesive; all from unspecified date and unknown if ongoing. Concomitant medications included unspecified medication for birth control, buspirone, and omeprazole magnesium (PRILOSEC); all from unspecified date for unspecified indication. There were no other vaccines received within 4 weeks. The patient experienced swollen lymph nodes/tender neck and lower face, pressure on left ear, headache, pain in upper right abdomen, and arm pain; all on 24Feb2021 10:30, which were considered non-serious events. No treatment received for the events. No COVID tests done prior and post vaccination. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
37 2021-05-28 ear pain health has been getting worse; have pains in her chest and back; have pains in her chest and back; m... Read more
health has been getting worse; have pains in her chest and back; have pains in her chest and back; making it difficult to move, breathe and cough; making it difficult to move, breathe and cough; coughing; coughing up bloody phlegm; constant waves of fever; cold chills; swollen lymph nodes; earache; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 09May2021 09:30 (Lot Number: EURO182) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that for the last 6 days her health has been getting worse, she have pains in her chest and back, making it difficult to move, breathe and cough. She's coughing up bloody phlegm and go through constant waves of fever and cold chills. She have swollen lymph nodes right side with a terrible earache. The events started on 11May2021 08:00. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.
37 2021-05-28 ear pain Upon awakening (17 hours after injection), had a headache; As the day progressed, my whole body star... Read more
Upon awakening (17 hours after injection), had a headache; As the day progressed, my whole body started to ache as well; intermittant shooting pains in my ears; Arm started to be sore at bed time (about 8-10 hours after injection); Woke up in middle of night (atypical for me) with general feeling of being unwell; do not have a fever but have been feeling colder than normal; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 16Mar2021 at 14:00 (at the age of 39-years-old) as single dose for COVID-19 immunisation. Medical history included kiwi allergy psoriasis, exercise induced asthma and HLAB27 associated anterior uveitis, all from an unknown date and unknown if ongoing. The patient previously took first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in left arm on 23Feb2021 at 14:15 for COVID-19 immunisation and had sore arm. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccine within four weeks of vaccination. Concomitant medication(s) included norethindrone, Vitamin D3, fish oil and multi-vitamin. On 16Mar2021 at 22:00 (8-10 hours after vaccination), patient arm started to be sore at bedtime and woke up in middle of night (which was atypical for patient) with general feeling of being unwell. On 17Mar2021 (17-hours after vaccination), upon awakening patient had a headache and as the day progressed, whole body started to ache as well and experienced intermittent shooting pains in her ears. On an unspecified date, patient not had fever but had been feeling colder than normal. Patient received no treatment for the events. Since the vaccination, patient had not been tested for COVID-19. The outcome of all the events was recovering. No follow-up attempts are needed. No further information is expected.
37 2021-05-28 extreme sound sensitivity about 5 minutes after administration pt. experienced strange hearing,dizziness; stated she was worke... Read more
about 5 minutes after administration pt. experienced strange hearing,dizziness; stated she was worked up and feeling her nerves taking over. i sat with her and she started feeling better. i gave her water and that seemed to help, too. she was soon on her way to going home attributing the incidence to anxiety. called her later and she was fine
37 2021-05-29 ear discomfort Chest tightness, tight jaw, nausea, dizziness, and feeling of full ears
37 2021-05-29 swollen tongue, lip swelling I have never had any food allergies, but I ate roasted peanuts yesterday for the first time since my... Read more
I have never had any food allergies, but I ate roasted peanuts yesterday for the first time since my covid vaccines. I had anaphylaxis, throat swollen shut, swollen lips tongue and face. shortness of breath, runny nose, coughing, vomiting, chest pain about 15 minutes after eating.
37 2021-05-31 mouth tingling Facial numbness and tingly sensation that began in the chin and jaw area a few days after the 2nd do... Read more
Facial numbness and tingly sensation that began in the chin and jaw area a few days after the 2nd dose. A week and a half later, the tingly sensation spread to the lips, cheeks and forehead. I am still experiencing this.
37 2021-06-02 mouth tingling, feeling of choking At 8:55 AM, on June 1, 2021, a slight tingling was felt in the fingertips of my rught arm. I then f... Read more
At 8:55 AM, on June 1, 2021, a slight tingling was felt in the fingertips of my rught arm. I then felt an increase of heart rate and my husband noticed my breathing was more rapid. I began to feel a slight tingling on the back undersides of my tongue and the top of my throat. I got up to walk and had to sit back down due to throat swelling and breathing reatriction. It was apparent to others around me due to the thick choked breathing I was experiencing. I felt my throat and jawline/cheeks feel puffed up. A nurse appeared to assist me, check my breathing and heart rate, and monitor my symptoms. I was not given an EPI injection, but was treated qith an adult dose of liquid benedryl, and 30 mg of Prednisone. I was then instructed to take benedryl at 4 hour intervals along with a dose of Zyrtec one I got home and again at bedtime then a single dose of Zyrtec for the next few days. I stayed an extra 30 min after the initial reaction took place for monitoring.
37 2021-06-03 taste impairment, swollen tongue Pt described feeling her heart rate high and feeling dizzy immediately after the vaccine, but she st... Read more
Pt described feeling her heart rate high and feeling dizzy immediately after the vaccine, but she stated because she has a phobia with needles, she attributed the feeling to that. She felt tired when she went home and went to bed. When she woke up this morning, her tongue was swollen, as was the left side of her neck. She stated she was drinking lots of water, but it tasted like chemicals. I recommended to the patient to take 2 benadryl, and if the symptoms did not subside, to go to the emergency room.
37 2021-06-03 taste impairment Employee completed 15 minute observation time after vaccination, then informed observers that she ha... Read more
Employee completed 15 minute observation time after vaccination, then informed observers that she had been feeling lightheaded and had a metallic taste in her mouth since just a few minutes after her vaccination had been given. She was advised to be seated again and did so. She was given water but refused juice. BP 132/80, Heart rate 60, Respiratory Rate 16 @ 1128. At 1132, recipient stated she felt better, we requested that she continue to stay for monitoring. At 1140, recipient said she felt fine, no longer lightheaded, but still had metallic taste in her mouth. She was able to ambulate without issues. Left at 1141.
37 2021-06-03 ear discomfort I had my first Pfizer dose on 3/16, I immediately got hot and flushed with high heart rate and hea... Read more
I had my first Pfizer dose on 3/16, I immediately got hot and flushed with high heart rate and heart palpitations. I was assured by multiple doctors that this was "normal". I was rushed to ER with sever pain my left leg and chest pain on 3/24/21. I was instructed this was all my anxiety and it was safe to receive the second dose. The anxiety and severe brain fog did resolve within 2 weeks. I stupidly received the second dose 4/7/21. I was fine for 3 days until I got severe ear pressure, severe vertigo, low blood pressure, high heart rate, GI symptoms, severe brain fog, anxiety, neurological issues and palpitations. 9 weeks later and I am still not recovered form the inflammation and Pfizer admitted "severe adverse reaction". I reported this to V-Safe and heard nothing back.
37 2021-06-03 burning mouth syndrome, tongue discomfort Vaccine exposure during pregnancy; Burning sensation on tongue; appearance of tongue sores; This is ... Read more
Vaccine exposure during pregnancy; Burning sensation on tongue; appearance of tongue sores; This is a spontaneous report received from a contactable consumer (patient). A 37-year-old pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206) via an unspecified route of administration in right arm on 06Mar2021 at 13:30 (at the age of 37-year-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history included hypothyroidism and PCOS (Polycystic ovary syndrome). The patient had allergy to Minute Maid Fruit Punch. The patient last menstrual period was 02Dec2020 and expected date of delivery was 05Sep2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included Levothyroxine (MANUFACTURER UNKNOWN), Prenatal vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; En9266) via an unspecified route of administration in right arm on 06Mar2021 at 15:00 as a single dose for COVID-19 immunisation. On 07Mar2021 at 02:00 am, the patient experienced burning sensation on tongue, followed by the appearance of tongue sores. It was reported that this happened frequently when the patient gets sick. Since, the patient was pregnant at the time of vaccination. Hence, vaccine exposure during pregnancy was captured as separate event. The patient did not receive any treatment for the events.The outcome of events burning sensation on tongue, followed by the appearance of tongue sores was recovering and other events was unknown.
37 2021-06-03 oropharyngeal discomfort Throat tightening/discomfort after the vaccine. The clinical lead gave 25 mg Benadryl and monitored... Read more
Throat tightening/discomfort after the vaccine. The clinical lead gave 25 mg Benadryl and monitored x 30 minutes with a return to baseline.
37 2021-06-03 visual impairment She got her vaccine, nothing happened after the first 15 minutes, everything was fine. Her arm was ... Read more
She got her vaccine, nothing happened after the first 15 minutes, everything was fine. Her arm was sore for about 2 1/2 days and then 4 days later she was nauseous, had vomiting, and that next morning and ever since she has had a terrible migraine. Her vision has either started to swirl and miss some spots in her vision, and then migraine pain and nausea that starts shortly after that. She has not gone to her doctor for her symptoms. She has taken Tylenol, Excedrin, and a Goodies powder with some relief, but they have not relieved the pain entirely.
37 2021-06-05 loss of taste, loss of smell Patient received 2 doses of Pfizer covid vaccine. Dates: 12/29/2020 and 1/15/2021
37 2021-06-05 lip itchiness Racing heart beat up to 125 bpm. Felt numbness on left arm Itching around mouth (lips) Dizzy
37 2021-06-06 loss of smell, loss of taste Mental decline. Short term memory is not as good as it used to be. It started after recovering from ... Read more
Mental decline. Short term memory is not as good as it used to be. It started after recovering from Covid. I had to bring it to my bosses attention because I could not retain anything. So steps were put into place to help me. Range of motion in my right arm, I couldn't lift anything for at least two months. I get random shock pains randomly in my arm. I can now lift things better. Reaching over my shoulder was also difficult. It aggravated the brachial nerve. I got a migraine that started at 11 am that morning. It woke me up at 2am the next morning. It stopped the next day. Loss of smell and taste. Nauseated. It was like french kissing a tailpipe. This all stopped like a light switch.
37 2021-06-06 tongue discomfort, taste disorder, mouth tingling Around 12 hours after receiving the 2nd dose of Pfizer vaccine (around 1:00am), I began to get extre... Read more
Around 12 hours after receiving the 2nd dose of Pfizer vaccine (around 1:00am), I began to get extremely tired (similar to the way one gets after taking a sedative). The next morning, I felt run down. I didn't want to get out of bed. Felt like a truck hit me. Very normal reactions so far. Foggy headed. Then got chills and a mild fever some time in the afternoon. Tongue *felt*(?) funny. Difficult to explain the sensation. Taste and tongue feel just felt different than usual. On Saturday (two days after the vaccine), I still felt run down, cold and foggy headed. Attempted to eat a cheese sandwich, but it hurt(!?). Felt like I really burnt my tongue on food, but did not. The rest of the symptoms were 90% gone by Sunday, the 3rd day after vaccine, but tongue still hurt. Noticed a few swollen taste buds on tongue on Monday (4th day after), and a sore on upper R gum area, near canine. It took roughly 5-6 days for tongue to return back to normal. "Odd" feeling remained for a few days more. I had been put off, for some reason, by wanting to drink coffee ever since day 1 after the vaccine. I drank it on Friday, but absolutely didn't want it on Saturday, or since. I have just been drinking tea. It is very strange for me, since I absolutely love(d) coffee and would normally drink several cups a day! Also, side random note: On Tuesday, the 5th day after the vaccine, I had a very random, very strong taste of rosemary while eating lunch (a tuna sandwich, prepared by myself). I didn't put rosemary in it. The taste subsided nearly as quickly as it came, which is odd considering if I were to have bitten into a rosemary leaf (that washow strong it tasted), the taste would have lingered for several more bites. It did not.
37 2021-06-09 dry throat client complained of dizziness after receiving 1st Pfizer Covid vaccine. Client alerted EMTs she was... Read more
client complained of dizziness after receiving 1st Pfizer Covid vaccine. Client alerted EMTs she was feeling dizzy and headache at 1330. Vitals at 1333: blood pressure 155/95, pulse 103, oxygen 98%. Per client dizziness 8/10, headache to occipital region 7/10. No medical history, medication or allergies. PHN arrived within 5 minutes. Upon arrival client sitting upright in chair, alert and oriented x4. Client denied blurry vision, chest pain, shortness of breath. At 1340 client able to transfer to anti-gravity chair with no assistance. EMT gave water. Vitals at 1342: blood pressure 144/91, pulse 105, oxygen 98%. Client stated feeling warm in face. PHN asked client to lower mask. Client's face flushed, hives on neck and upper chest. Per client dizziness and nausea same. Client denied shortness of breath. Clinic offered client Benadryl, client accepted. Daughter present and would drive client home. Bendaryl 50mg IM given at 1344 on right deltoid. 1345 client stated itchy throat feeling, clinic assessed for swelling, client denied throat closing. Client speaking in full sentences. Vitals at 1352: blood pressure 132/86, pulse 91, oxygen 97%. Face flushed, hives on neck. Per client headache 6/10 and dizziness improving and only felt warmth in cheeks. Vitals at 1357: blood pressure 127/85, pulse 89, oxygen 98%. Per client headache resolved, dizziness 6/10, felt dry throat but no itchiness or shortness of breath, warmth in cheeks improving. Client face flushing improving, no hives in upper chest, hives on neck and improving. Clinic gave client some water upon request, advised to take small sips. Client stated was able to swallow with no problem. Vitals at 1407: blood pressure 131/78, pulse 83, oxygen 98%. Per client dizziness, headache and warm feeling resolved. Client with redness in cheeks and neck. Vitals at 1414: blood pressure 130/82, pulse 95, oxygen 100%. Client cheeks and neck pink, no hives. Client denied feeling warm, dizzy, headache, shortness of breath. Per client feeling much better and was ready to home home and rest. PHN advised client to follow up with provider and gave ER precautions. Daughter would drive client home. Client left facility with steady gait at 1423.
37 2021-06-09 ear pain The left side of my face swelled a bit,redness, completely numb; The left side of my face swelled a ... Read more
The left side of my face swelled a bit,redness, completely numb; The left side of my face swelled a bit; ear aching; redness; Teeth aching; face aching; This is a spontaneous report from a contactable consumer (patient herself). A 37-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6204/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 09Mar2021 (at the age of 37-years-old) as 1st dose, single dose for covid-19 immunisation at Public Health Clinic. The patient medical history was not reported. Concomitant medication included azithromycin (AZITHROMYCIN) (5 pack) taken for an unspecified indication from an unspecified start date to 02Mar2021. The patient previously took ceclor (CECLOR) and experienced allergy, percocet [OXYCODONE HYDROCHLORIDE; PARACETAMOL] and experienced allergy, doxicycline [DOXYCYCLINE HYDROCHLORIDE] and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was also reported that since the vaccination the patient had not been tested for COVID-19. On 09Mar2021 at 14:30, the reporter stated that, the left side of my face swelled a bit, redness, completely numb. By the next day, the redness and swelling seem to mostly be gone, but my face was still numb. There was teeth aching, ear aching, face aching, just the left side. Therapeutic measures were taken with Prednisolone for the events. The reporter stated the events result doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. No Follow up attempts are possible: No further information is excepted.
37 2021-06-10 canker sore About a week after receiving, second dose I noticed a canker sore on my inner lip. It healed and ano... Read more
About a week after receiving, second dose I noticed a canker sore on my inner lip. It healed and another one appeared. Now, more than 2 weeks later, I have multiple mouth sores inside my lips and underneath my tongue.
37 2021-06-10 taste impairment Metallic taste; Headache; This is a spontaneous report received from a contactable consumer, the pat... Read more
Metallic taste; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 36-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot number: EN6202), via unspecified route of administration in the right arm on 25Feb2021 at 17:00 hours as a single dose for COVID-19 immunisation. Medical history includes major depressive disorder, ADD (attention deficit disorder), hyperprolactinemia, Prolactinoma, vitamin D deficiency, anemia (only during week of period or if ill) from an unknown date. The patient has sensitivities to Hydrocodone, latex, Neomycin, nuts, dairy, gluten. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID 19. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included VYVANSE, hydroxychloroquine (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN) which were received within two weeks of vaccination. On 25Feb2021, the patient experienced metallic taste within 1 to 2 minutes of having the vaccine shot, which lasted 12 to 24 hours and headache within 3 to 4 hours after having the vaccine shot, which lasted 24 hours. Patient did not received treatment for the reported events. The clinical outcome of the events metallic taste and headache was recovered. No follow up attempts are possible. No further information is expected.
37 2021-06-10 ear discomfort, ringing in ears First 5 days I experienced insomnia, anxiety, and vibrations/pulsations on the soles of my feet. I w... Read more
First 5 days I experienced insomnia, anxiety, and vibrations/pulsations on the soles of my feet. I was unable to fall asleep naturally and felt like I had way too much energy (the uncomfortable kind of energy). When trying to sleep, my brain would jolt me awake. I felt two pops on both sides of my forehead the second night after being vaccinated. After 5 days of only 4 hours sleep per day, I was finally able to sleep more hours. I still have days where I am not sleeping well. My ears also felt full and still do, which I have not experienced in years. After the insomnia subsided, my tinnitus increased to extremities that I have never experienced in my entire life of having mild-tinnitus. My tinnitus is loud keeping me awake and making it hard to sleep and triggering ongoing anxiety. The enhanced tinnitus began around May 30th and still going. I have not had anxiety this bad in several years. The vaccine has triggered this and it is debilitating. I also feel "cramps" near where my heart is every now and then - which is also concerning.
37 2021-06-13 toothache Patient experienced pain on the right side of her face and teeth, sinus headache the next day after... Read more
Patient experienced pain on the right side of her face and teeth, sinus headache the next day after the second dose of the vaccine and the symptoms have not been subsided since 06/10/2021. Her current pain level is on scale of 5/10 at the moment. Sinus Headache is the symptoms that causes her the most discomfort
37 2021-06-13 vision blurred Sort story, since getting the vaccine(s) I have experienced persistent body itch, GI-related abdomin... Read more
Sort story, since getting the vaccine(s) I have experienced persistent body itch, GI-related abdominal pain, fatigue, and hypersensitivity to a variety of oral medications and to the endoscopy/biopsies, though tests have largely shown that I'm normal. I got the second Pfizer-BioNTech Vaccine in my right arm on 04/23/2021, but the system won't let me enter that. 2 days after receiving the vaccines, I had fatigue and arm pain. 4 days after the vaccine, I was given one dose of flagil and a 5 day treatment of metronidazole for a suspected UTI or BV, even though tests for both came back negative. I developed a severe body itch that has since died down but still intermittently persists 2.5 months after the first dose of the vaccine and 1.5 months after the second dose. Topical steroids have done nothing to help, so they were discontinued. 4 days into the metronidazole I was told to discontinue due to significant adverse side effects. About that time I also started having chest pain. On or about April 14th I went to the ER for significant chest pain. Tests were largely okay, and it was speculated that I had gastritis. I was given an Rx for 20mg a day of omeprazole and told to get an endoscopy. I discontinued the omeprazole due to significant adverse side effects. I switched to 10mg of Pepcid for a couple of days, but I had significant side effects from that as well and discontinued therefore use. I was feeling better (still with some intermittent fatigue and body itch) when I went in for the endoscopy on June 7. I was told the procedure went really well and shouldn't anticipate much by way of side effects. Later that afternoon, I started having a sore throat, abdominal cramps, and the next day I also started having some chest pain. Called the doctor on call and received an Rx for dicyclomine, 2 pills x 2x day. Did that for one day and started having blurry vision and mood alterations. Discontinued that use and have slowly started feeling less cramps, but they still off-and-on persist.
37 2021-06-14 taste impairment Odd taste in mouth
37 2021-06-14 visual impairment Chronic cluster and migraine headache with vision changes, joint pain, short term memory and concent... Read more
Chronic cluster and migraine headache with vision changes, joint pain, short term memory and concentration issues - onset after vaccine to current date.
37 2021-06-15 taste impairment About 1 day after receiving vaccine had fever and fatigue as well as burning at site, heart palpatat... Read more
About 1 day after receiving vaccine had fever and fatigue as well as burning at site, heart palpatations and "feeling like my heart was weak". This resolved on it's own after a day or two. Currently experiencing intermittent metallic taste in mouth that started about a week after receiving vaccine.
37 2021-06-16 eye strain, bloodshot eyes Pt w/ hx of allergy to Penicillin, Reglan, Zofran (rash). Pt w/ a PMH Bowel obstruction and Anxiety... Read more
Pt w/ hx of allergy to Penicillin, Reglan, Zofran (rash). Pt w/ a PMH Bowel obstruction and Anxiety. Pt c/o flushing/sweating, dizziness, heavy/red eyes 3mins after vaccination. BP 86/51, HR 68, RR 18, Temp 97.8 -- > 123/74 -- > 103/82. Had pt lean back and elevate feet. Blanket given to the pt as they felt cold. Benadryl 50mg IM given 12min after vaccination. Pt also given water. Pt states that they feel better; just got scared. Pt stable and released from the vaccination site. Recommended that pt f/u with healthcare provider, instructions provided.
37 2021-06-17 eye disorder, mouth numbness left side facial paralysis/left half of her face became paralyzed; numbness on the left side part of... Read more
left side facial paralysis/left half of her face became paralyzed; numbness on the left side part of her face; her tongue is still numb; cannot blink her left eye; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route on 26May2021 (at the age of 37-years) at left shoulder as single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0179), via an unspecified route on 05May2021 as single dose in the left arm for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not took any other products. On 07Jun2021, the patient experienced left side facial paralysis/ left half of her face became paralyzed which was facial paralyzed. It started to have numbness on the left side part of her face and it already went out since yesterday, but her tongue was still numb. She has been experiencing numbness but not painful. She also cannot blink her left eye. Patient stated that numbness went away but the look got worse and sometimes feels numbness but not all the time. Patient stated that she started drinking B complex vitamins yesterday. She wanted to know if this was a recorded side effect of the vaccine and if she needs to see a doctor for treatment. Patient stated that she just searching online probable connection to Pfizer and facial paralyzed and saw there were some studies that connected the two. The patient did not went to Emergency Room. Patient stated she just had a phone consultation from her country it was just a virtual consultation to a doctor, but she did not go to a doctor here. Patient stated she decided to get it to be protected since she has never been infected with COVID and when it was available, she got it to feel safe. The outcome of events was left side facial paralysis and her tongue was still numb, cannot blink her left eye was not recovered, numbness on the left side part of her face was recovering. Information on Lot/Batch number was available. Additional information has been requested.
37 2021-06-17 mouth swelling, lip swelling Bottom lip started welling same day of vaccination and it stop on its own the same day and exactly ... Read more
Bottom lip started welling same day of vaccination and it stop on its own the same day and exactly 2 weeks later my right side of the face began swelling I went to the ER and my whole face was swollen face inside my mouth. they said I wasn't anaphylaxis I .was given steroids and anhistamines and Pepcid. They tested me for autoimmune disease ANA came back positive and endocrinologist did a US thyroid and everything was normal and he changed my medications and vitamin D and I saw an RA specialist. they did x rays on my hands and they did ANA and it came back negative. after 18 days it started disappearing.
37 2021-06-18 taste impairment My mouth had a metallic taste.; This is a spontaneous report from a contactable consumer, the patien... Read more
My mouth had a metallic taste.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non pregnant female patient received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via unspecified route of administration, administered in left arm on 19Mar2021 at 14:45 (at the age of 37 years old) as a single dose for COVID-19 immunisation. Medical history included svt, asthma. Concomitant medication included BYSTOLIC, ADVAIR, PROTONIX, vitamin d (MANUFACTURER UNKNOWN), and TYLENOL for unknown indication and unknown duration. The patient reported of allergic reaction to food but not exactly sure about the ingredient that caused. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID 19 prior to vaccination. Since the vaccination patient had not been tested for COVID-19. The patient experienced metallic taste in mouth on 19Mar2021 at 15:00. The clinical outcome of the event metallic taste was unknown at the time of reporting. No follow up attempts are needed. No further information is expected.
37 2021-06-20 ear pain Symptoms, most severe to least: Seizure (non-epileptic): 3:05-3-45pm, May 12th, 2021 2:55-3:25am,... Read more
Symptoms, most severe to least: Seizure (non-epileptic): 3:05-3-45pm, May 12th, 2021 2:55-3:25am, May 15th, 2021 Approx 1-2pm, May 27th, 2021 4:45-5:20, June 6th, 2021 These are a half-hour+ of jerking (arms and legs) many times a minute, back arching, muscle locks, and muscle spasms. I retain consciousness and control between jerks, usually, though they are very painful and exhausting. Note: I do have a medical history of Tourette?s, so these non-epileptic seizures are not new to me, and are generally manageable at home with hydration and safety practices unless they last more than a few hours. But I hadn?t had any in a couple years prior to the shot, as they are far more rare than they were a decade ago. Weakness (cannot walk or stand unsupported, cannot lift heavy (and sometimes even light) objects, wobbly legs, shaky arms, etc.) 2:50pm, May 12th to present This weakness rapidly increased from wobbly legs in the waiting room to unable to walk on my own or stand unsupported. It was extremely bad the first few days, then from May 17th seemed to slowly get a bit better day by day as I could walk a few steps and lift a jug of milk, then relapsed and has varied in terms of how extreme it is day by day. Currently I am using a walker to get around the house, except on days where I am too weak for that and have to stay mostly in bed. Weakness on evening of Jun 1st was so bad that my head felt like a bowling ball I was trying to balance, and I could not hold my head up unassisted as it would fall forward, backward, or to the side. I went to bed early (7:30 about) and in the morning I could move my head again normally. Lots of falls and partial falls (Often body ?locks down? after a fall and I cannot move my legs, and sometimes arms, to get up again unassisted, so I?ve been on the floor 5+ minutes.) Most falls from standing or walking position, but a few have been from sitting or kneeling. Some of these feel like legs or back giving out due to weakness, others feel like my legs or back just stopped working right. Dizzines: 2:45pm, May 12th to Evening May 14th It?s been on/off since, but has mostly cleared up. Severe Fatigue: 3:00pm, May 12th to present Very tired, need a lot of extra sleep, hard to focus on things. Even climbing stairs or walking a bit with the walker can be exhausting and I need a long break of sitting to recuperate. Some days am so weak and tired I have to stay in bed, and can?t get much done. Pain: May 12th to present. It increases with activity and sometimes at night in back/right hip/left wrist especially. Left wrist is the most severe in persistence ? it will often buckle in pain if I try to support myself with it or catch myself from a fall with it. Pain in my right leg was also so bad the night of the 13th it was difficult to sleep. My spine, left wrist, and right hip/pelvis seem to have the worst on/off pain, though my back and legs often ache a lot in the early morning. ?Glitchy? muscles: May 12th to present, worsening. Goes along with the weakness, but it feels like a muscle (especially legs) will glitch out and not work right. This slowly got worse for about a week after the shot, and has been pretty bad since. While sometimes the glitching causes my legs to buckle or I?ll drop something because my hand releases, it more commonly is just weird things like my legs and feet turning sideways or pointing weird. Minor to moderate stabby headache: 2:50pm 12th to present, intermittent, managed by Tylenol. It was worse the first week after, but now seems to be every few days. Earaches: ~May 17th to present. On and off, often accompany headaches - every few days. Both ears, sometimes just right. Sore arm: From injection around 2:40pm May 12th to morning of the 14th There are spots in the upper left arm which are still sore when pressed. As mentioned under the pain section, my left wrist still hurts immensely when weight is put on it. Minor Fever (estimate 99-100 degrees max) and/or Hot/Cold flashes: Had chills and low fevers? It seemed on and off for a few days after the vaccine, so more than just recorded. Night of the 12th, broke around 2am on the 13th Night of the 14th, broke around 2:45am on the 15th Afternoon of the 15th, broke around 6pm June 9th, some of the day on and off Abdominal Cramps & nasuea: 12th-14th (not on period or pregnant at that time.) Bowl issues: Mild Diarrhea for a couple of weeks after the shot. It also was more difficult to go pee/empty my bladder, as muscles seemed week and it could take 20 minutes to empty my bladder incrementally. I also had some minor leaking. This cleared up, though, no current bowl issues. Shortness of breath: Mild shortness of breath after the shot for a couple days where I could not speak at extra volume, read aloud or talk for a length of time, or take ?deep? breaths. This has mostly resolved though sometimes I will briefly get a little short of breath. Muscle twitching and jerks: Since childhood. Since May 12th it has been worse than in the past few years, though. Started calming down a bit about June 10th. Brain fog: For about a month after the shot, it was really hard to focus or keep on top of things. It got to the point my kids would literally move my head towards them and say, "mommy, you aren't listening!" to get my attention, and my sister and others also complained that I wasn't focusing on them. It was really hard to manage paperwork and arranging doctors as well.
37 2021-06-20 sensitivity to light, eye pain So, Photo Phobia an eye pain. I was feeling myself for 5 days and I wore sunglasses because of the l... Read more
So, Photo Phobia an eye pain. I was feeling myself for 5 days and I wore sunglasses because of the light. I was able to work but not really functional. It wasn't a margaine. Just a really bad headache. I was also confused for a day or so. That's not like me. I was having problems remembering things but it went away the following.
37 2021-06-23 ringing in ears When I was at the Hospital I got dizzy after getting the vaccine administered. I couldn't not sleep... Read more
When I was at the Hospital I got dizzy after getting the vaccine administered. I couldn't not sleep that night I had serve insomnia. I had two bumps come up on my forehead. My energy quickly depleted. For two weeks I gave anxiety and I struggle to rest at night. I wake up with a ton of energy. I started having tinnitus (ringing noise in my ear). I am still dealing with the anxiety and tinnitus. I also had a weird vibration through the bottom of my feet. I also have the hypnic jerks as well. Its been a rough 4 weeks.
37 2021-06-24 loss of smell Could not smell; a very sore arm; This is a spontaneous report from a contactable consumer, the pati... Read more
Could not smell; a very sore arm; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 14.00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history reported was asthma. Concomitant medication included sertraline (MANUFACTURER UNKNOWN) and DAYQUIL. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 16:00, the patient could not smell and had a very sore arm. The patient did not take any treatment for the reported events. The clinical outcome for the event loss of smell and very sore arm was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
37 2021-06-24 oropharyngeal discomfort Nasal congestion; shaking chills; Momentary feeling of a lot of heat; sweat; burning throat; No mens... Read more
Nasal congestion; shaking chills; Momentary feeling of a lot of heat; sweat; burning throat; No menstrual period; Cough; This is a spontaneous report from a contactable consumer or other health care professional (patient). A 37-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0177) via an unspecified route of administration, administered in Arm Left on 12May2021 19:30 (at the age of 37 years old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient did not receive any other vaccines within four weeks and within 2 weeks of vaccination. On 15May2021 10:00am, the patient experienced shaking chills, momentary feeling of a lot of heat, sweat, cough, nasal congestion, burning throat and no menstrual period. The patient was treated with Tylenol Flu, Antibiotic for the adverse events caused. The patient underwent lab tests and procedures which included oral swab test results negative on 25May2021. The clinical outcome of the events was recovered with sequelae on an unspecified date in May2021. Follow up attempts are needed. Further information has been requested.
37 2021-06-24 visual impairment half of her body she is feeling numb; Dizzy; cannot see well from the right side of her right eye; h... Read more
half of her body she is feeling numb; Dizzy; cannot see well from the right side of her right eye; heart is beating faster; can barely talk; throat closing; Allergic reaction; her throat clogged; difficulty breathing; Face swell; This is a spontaneous report from a contactable consumer. This consumer reported for a 37-year-old female patient (reporter's sister) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 08May2021 12:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included paracetamol (TYLENOL) taken for stomach hurt from 07May2021 to an unspecified stop date. The reporter called on behalf of the patient, that the patient got the vaccine on Saturday, 08May2021 at 12:15, so right after the administration of the first dose, the patient had allergic reaction, her throat clogged, throat was getting closed, had difficulty breathing and then her face started to swell, and the patient was administered or took an anti-allergic medicine and was sent to emergency room and they said it was an allergic reaction. The patient was still feeling bad. The reporter provided the important safety information, and the reporter were also asking why the common side effects was not advised before the administration. The reporter and patient went to the emergency room and was there until 1:00 am on Sunday, 09May2021. The caller was never admitted as a patient into the hospital. On 09May2021, when the patient left the emergency room, patient started that she was feeling numb on half of her body, started feeling dizzy, couldn't see well from her right-side eye, her heart was beating faster, and she can barely talk. The patient being able to barely talk comes and goes. The patient received the treatment in the emergency room. Reporter stated, "It's for side effects for vaccine she had allergies to the vaccine." The outcome of the events was allergic reaction, her throat clogged, difficulty breathing, face swell, can barely talk, throat closing unknown. The outcome of the events was half of her body she is feeling numb, dizzy, cannot see well from the right side of her right eye, heart is beating faster was not resolved. No follow-up attempts are needed. information about lot/batch number cannot be obtained.
37 2021-06-27 oral mucosal blistering Ever since I got the vaccine shots I have been sick on and off and had horrible allergies. Before th... Read more
Ever since I got the vaccine shots I have been sick on and off and had horrible allergies. Before the vaccine I was rarely sick and didn't have bad allergies. There is no proof this is related to the vaccine but I just think it's strange. I have had sore throat, snotty nose, cough, sinus pressure, blisters in my mouth, headaches, I went and got a steroid shot last month and I'm finally getting some relief. I dont know that this is related but I just think it's crazy I have been sick so many times after the shot and the actual shots made me sick too.
37 2021-06-29 swollen tongue, eye swelling, swollen gums, lip swelling Swelling of tongue began at 3:42pm. Took Benedryl 25 mg and waited at vaccine clinic for 30 minutes.... Read more
Swelling of tongue began at 3:42pm. Took Benedryl 25 mg and waited at vaccine clinic for 30 minutes. Lips, eyes, upper gums, and throat also began to swell. Advised by clinic that I could either be observed more at the clinic or go to ER. My husband and I decided to leave (around 4:15 pm) and see if I will improve at home but started getting shortness of breath 5 minutes after leaving, and headed back to the ER. It took about 30 minutes to get processed/checked-in at the ER and received oral Benedryl 25 mg, Pepcid 20 mg, and Prednisone 50 mg at approximately 5:00pm. By about 7:00pm, the swelling had reduced and the ER discharged me around 8:00pm with oral Benedryl 25 mg, Pepcid 20 mg, and Prednisone 50 mg. Today is 6 days after the vaccine and still have continuous minor swelling every day.
37 2021-07-04 mouth tingling, mouth numbness About 20 minutes after injection the right side of my tongue began tingling. It was very noticeable,... Read more
About 20 minutes after injection the right side of my tongue began tingling. It was very noticeable, and persisted all day. About 4-5 hours after injection, the right side of my face and right side of my lips also felt slightly tingly and slightly numb. No noticeable swelling, but my husband detected less movement on the right side of my face and said that my speech sounded like I had a bit of a fat tongue. I took ibuprofen to relieve symptoms. The next day the tingling in my tongue was gone. The weird feeling on the right side of my face was improved, but still there. It was distracting enough that I continued taking ibuprofen which seemed to help. It has now been 72 hours since my injections. The weird feeling of the right side of my face/lips being slightly tingly and numb persists. It improved that first night, but has not improved any more since then.
37 2021-07-05 ringing in ears, hearing loss I developed a seizure about 6 hours later, probably went off for 5 minutes. When it ended I had tinn... Read more
I developed a seizure about 6 hours later, probably went off for 5 minutes. When it ended I had tinnitus, really bad ear ringing that was extremely loud, I could not hear any sounds really well. The following days I could not drive my car, walk or eat. I got to see an ear, nose and throat doctor, he did and ear exam and said I had partial hearing loss in my left ear. He did not have any answers for me. He reported to Pfizer and they sent me a big package and send it back, I also completed the Agency report. I saw other doctors and they could not do anything for me. I was paying out of pocket since I did not have insurance. I ran out of money. I started treating my self. At the 6th week I developed really bad neuropathy on my arms, feet and head. I developed shooting pain on my injection site. I went to the ER, they said I had elevated troponin levels which indicated heart damage. Now I struggled to use my hands and feet. I have not had any other health problems before. It has been a rough couple of months. The new symptom I developed after filing the first report is the neuropathy.
37 2021-07-07 mouth numbness, mouth tingling Tingling , numb sensation on tongue and lips at beginning. After 3 months tongue still Tingling.
37 2021-07-07 tongue disorder SPOTTING COVID TONGUE
37 2021-07-08 taste impairment Metal taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 37-ye... Read more
Metal taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL9269) via an unspecified route of administration in the left arm on 18Mar2021 at 16:15 (at the age of 37 years old), as a single dose for COVID-19 immunisation. The patient had known allergies to lobsters and shrimps. The medical history of the patient and concomitant medications was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL9266) via an unspecified route of administration in the left arm on 25Feb2021 at 16:15 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, the patient experienced metallic taste. No therapeutic measures were taken as a result of the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event metallic taste was not recovered at the time reporting. No follow-up attempts are needed. No further information is expected.
37 2021-07-08 ear pain extremely tired; super lathargic,; sore throat started; Fever was ranging between 101-102 degrees; c... Read more
extremely tired; super lathargic,; sore throat started; Fever was ranging between 101-102 degrees; chills; headache; nausea; glands in neck on left side swollen; Day 1 (day after getting vaccine) woke up with severe pain next to the left ear Day 2: same pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) in the left arm 21Mar2021 at 13:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Patient medical history included high cholesterol and eczema. Concomitant medications included norethindrone (NORTREL) and sertraline (MANUFACTURER UNKNOWN) both for unknown indications from unknown dates received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had undergone a COVID-19 nasal swab test and the result is pending. The patient reported no known allergies to medications, food, or other products. On 22Mar2021 at 06:00 am, the patient had severe ear pain next to the left ear, on 24Mar2021, the patient had glands in neck on left side swollen and hurt to touch, sore throat, fever at 101-102 degrees, chills, headache and nausea, on 25Mar2021, the patient was not able to get out of bed, the patient also had fever at 102 degrees, sore throat and was super lethargic and on 26Mar201, the patient woke up with throat on fire and extremely tired. The events resulted in emergency room visit/ doctor or other healthcare professional office visit. Therapeutic measures taken as a result of the events ear pain, painful lymphadenopathy, sore throat, fever, chills, headache, nausea, lethargy and tiredness included treatment with TYLENOL extra strength. The patient underwent lab tests and procedures, which included COVID nasal swab test on 26Mar2021 and the report was pending, on 26Mar2021, the patient had strep test and the result was negative. The clinical outcome of the event severe ear pain was resolved on 24Mar2021, the clinical outcome of events headache and nausea was resolved on 25Mar2021. The clinical outcome of the events painful lymphadenopathy, sore throat, chills, lethargic, tiredness and fever was recovering at the time of report. No follow-up attempts are needed. No further information is expected.
37 2021-07-08 vision blurred Tingling hands; Heart palpitations; Elevated heart rate and blood pressure; Elevated heart rate and ... Read more
Tingling hands; Heart palpitations; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Nausea; Vomiting; Shaking; Chills; Blurred vision; Injection site pain; Muscle pain; Headache; Fatigue; Malaise; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 37-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN 6204 and expiry date: unknown), via an unspecified route of administration, in left arm on 10Mar2021 at 16:30 (at the age of vaccination was 37-years-old) as single dose for COVID-19 immunization. The patient's medical history included mild aortic regurgitation, abdominal adhesions, inappropriate sinus tachycardia, had emergency laparotomy and hysterectomy on 4Apr2020 for severe infection post C-section. The patient had no concomitant medications. The patient had known allergies: sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Mar2021 at 16:45, the patient experienced tingling hands, heart palpitations, elevated heart rate and blood pressure, nausea, vomiting, shaking, chills, blurred vision, injection site pain, muscle pain, headache, fatigue and malaise. The patient did not receive any treatment medication for the events. The patient received large doses of zosyn, augmentin, as well as lovenox from 23Mar2020 through about 15Apr2020. On 10Mar2021, the patient underwent lab tests which included blood pressure measurement was elevated, heart rate was elevated. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
37 2021-07-11 visual impairment the patient felt very hot and sweaty shortly after receiving the vaccine. She also noted some visua... Read more
the patient felt very hot and sweaty shortly after receiving the vaccine. She also noted some visual impairment as well. We provided an ice pack and some water and she felt better. She stayed in the pharmacy for 30 minutes after administration.
37 2021-07-12 lip itchiness, swollen tongue Throat swelling; tongue swelling; itchiness of throat; itchiness of lips; Difficulty breathing; Exha... Read more
Throat swelling; tongue swelling; itchiness of throat; itchiness of lips; Difficulty breathing; Exhaustion; high fever; joint pain; aches; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 22Mar2021 at 10:45 (at the age of 37-years-old) as single dose for COVID-19 immunisation and received the second dose for BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on unknown date as single dose for COVID-19 immunisation. Medical history included COVID-19; the patient had mushroom allergy. Prior to vaccination, on an unknown date the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any vaccine within four weeks prior to the COVID-19 vaccine. On 22Mar2021 (within 30 minutes of vaccination), the patient experienced aches, chills, difficulty in breathing, exhaustion, high fever, itchiness of lips, itchiness of throat, joint pain, throat swelling, tongue swelling. Therapeutic measure takes as a result all events included treatment with BENADRYL. The clinical outcome of the events aches, chills, difficulty in breathing, exhaustion, high fever, itchiness of lips, itchiness of throat, joint pain, throat swelling and tongue swelling were unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
37 2021-07-12 bloodshot eyes face and hands turned red; whites of my eyes were red as well; burning up and hot to the touch; smal... Read more
face and hands turned red; whites of my eyes were red as well; burning up and hot to the touch; small rash on multiple body locations; lump in the back of my throat; My hands swelled; My body temperature was also at a low grade fever; BP, heart rate, and sugar levels were abnormally high; BP, heart rate, and sugar levels were abnormally high; BP, heart rate, and sugar levels were abnormally high; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection Lot Number: EL9265) via an unspecified route of administration in right arm on 11Feb2021 at 15:30 as dose 2, single (at the age of 37-years-old); and previously received first dose of BNT162B2 (Lot Number:EL8982) via an unspecified route of administration in left arm on 15Jan2021 at 10:30 as dose 1, single (at the age of 37-years-old); both for COVID-19 immunization at hospital. Medical history included Crohn's, Ulcerative Colitis, Premature Menopause; all from an unknown date and unknown if ongoing. Patient had known allergy to sulfa. Concomitant medications within 2 weeks of vaccination included BUPROPION, DHEA, BUSPIRONE, ESTRADIOL; all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. On 13Feb2021, 2 days after the second vaccination, the patient experienced a small rash on multiple body locations. On 14Feb2021, 3 days after the second vaccine, Patient had face and hands turned red, and it moved inward to cover the top half of body. The whites of her eyes were red as well. Patient was burning up and hot to the touch all over. No hives and no itching. It was reported on an unspecified date in Feb2021, patient also felt like she had a lump in the back of throat, and experienced hands swelled, body temperature was also at a low-grade fever. At the ED, it was noted patient's Blood pressure (BP), heart rate, and sugar levels were abnormally high and had no history of any of those being high. The patient underwent lab tests and procedures in Feb2021, which included blood glucose, blood pressure measurement, heart rate resulted as high on an unspecified date; and body temperature was low-grade fever on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19. Adverse event resulted in emergency room/department or urgent care. Treatment received was steroids, pepcid, Benadryl. The outcome of events was unknown. Follow-Up (08Jul2021): Follow-up attempts are completed. No further information is expected.
37 2021-07-13 loss of taste At 7am the morning after I took the second vaccination, I woke up with major flue like symptoms. My... Read more
At 7am the morning after I took the second vaccination, I woke up with major flue like symptoms. My whole body ached all over. My left arm was swollen where they injected me and it so painful where I could not even move my left arm. I hurt every where throughout my body. I literally felt like I had been poisoned. I was running a 100 degree fever, I was nauseated and very fatigued. I felt dizzy and had to lay down all day. I was a bit congested. I could not really taste food and had no appetite. I had some shortness of breath. This lasted for a couple days. The fever finally went away after 24 hours. I was nauseous and still had trouble eating four days after the shot. I?ve been tired and fatigued still five days after the shot but I seem to be regaining my strength slowly.
37 2021-07-13 taste impairment, feeling of choking Metallic taste and tingling in throat about 14 mins after shot. This happened with the first shot to... Read more
Metallic taste and tingling in throat about 14 mins after shot. This happened with the first shot too. With the 1st shot my throat was itchy/achy for a few days but nothing serious occured with the 1st dose so I said nothing about the sensation with the 2nd dose. About 5 minutes after leaving (20 mins after receiving 2nd dose) the sensation in my throat worsened and my throat tightened. My throat was itchy. Arriving home I took my inhaler (Albuterol) since the tightening feeling somewhat reminded me of the onset of an asthma attack. But finding no relief I took Benadryl and layed down. Since July 2nd my throat has on and off bothered me. Nothing severe or painful just bothersome. It's not constant. Its On and off sometimes I'll experience tightness scratchiness or a odd tingling taste and sometimes I'm fine.
37 2021-07-13 sensitivity to light After my 2nd dose I had a bad headache the day after. Now I have noticed that I get similar headache... Read more
After my 2nd dose I had a bad headache the day after. Now I have noticed that I get similar headaches more often, maybe once every 4-6 weeks that are severe enough that I need to take ibprophin and at times am sensitive to light. My period has also been irregular as it used to come on the dot every 28 days and now it varies more. It's hard to discern whether this is related to the vaccine or whether it is related to the parathyroidectomy I had in Dec 2019, or related to stress because I work in a hospital during the pandemic.
37 2021-07-15 pupils dilated Immunization was administered at 2:41pm, aprox 2:45pm patient slumped over in clinic room chair- wit... Read more
Immunization was administered at 2:41pm, aprox 2:45pm patient slumped over in clinic room chair- with snoring respirations, bilateral pupils dilated 5mm, became rigid, diaphoretic, and started having tonic clonic seizure activity lasting for approximately 4 mins, patient was lowered to ground for safety- 911 was activated- patient slowly regained consciousness post event- patients blood glucose = 100. HR 110 SPO@ 98%RA; patient denies previous seizure activity or history of seizures, denies drug abuse. Patient is transported to local hospital.
37 2021-07-17 taste impairment swollen sore right arm; Metal taste; swollen sore right arm; This is a spontaneous report from a con... Read more
swollen sore right arm; Metal taste; swollen sore right arm; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the right arm on 28Mar2021 at 16:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had a history of allergy to black ants, cockroaches and had seasonal allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 16:45, the patient experienced swollen sore right arm, and had metal taste which was like, she had a coin in her mouth that would not go away. She tried drinking lots of fluids, eating and mouth wash, which was not beneficial. Other than that, the patient felt fine. These events started about 30 minutes to an hour after the vaccination. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events swollen sore right arm and metal taste was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
37 2021-07-17 mouth numbness Sweating, mouth went numb, itchy burning hands blotching on palms... Tight chest labored breathing ... Read more
Sweating, mouth went numb, itchy burning hands blotching on palms... Tight chest labored breathing tingling itching all over body... Extremely itchy cheeks and face
37 2021-07-17 oropharyngeal discomfort Congestion of throat; Fatigue; Muscle ache; Chills; Headache; This is a spontaneous report from a co... Read more
Congestion of throat; Fatigue; Muscle ache; Chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER7613), via an unspecified route of administration in the left arm on 18Mar2021 at 17:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. The patients medical history included penicillin allergy. The patient's concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 09:00, the patient experienced fatigue, muscle aches, congestion in throat, chills and headache. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, myalgia, congestion in throat, chills and headache were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
37 2021-07-17 tongue itchiness, mouth tingling Back of Tongue tingly and itchy; Back of Tongue tingly and itchy; This is a spontaneous report from ... Read more
Back of Tongue tingly and itchy; Back of Tongue tingly and itchy; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206, Expiration date not reported), via an unspecified route of administration in arm left on 09Mar2021 09:00 (at the age of 37-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. patient had no known allergies. Patient did not had covid prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.25 mcg taken for an unspecified indication, start and stop date were not reported and was taken within 2 weeks of vaccine administration. Patient did not receive any other vaccinations with in 4weeks prior to vaccination. Patient was not tested for covid post vaccination. On 10Mar2021 12:00 the patient experienced back of tongue tingly and itchy the day after vaccination on and off for 2 days. The patient did not receive any treatment for the event. The outcome of back of tongue tingly and itchy was resolved on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
37 2021-07-19 lacrimation increased Severe unilateral (right) sided headaches that happen multiple times per day. My right eye will wate... Read more
Severe unilateral (right) sided headaches that happen multiple times per day. My right eye will water and right nostril will get a burning sensation and will be congested during the headache. Headaches last around 3 hours and happen 3-5 times per day. Headaches feel as if someone is drilling a hole in my right temple. Doctor has diagnosed me with Cluster Headaches. I was prescribed steroids then the standard preventative medication which is Verapamil. Headaches have subsided significantly with the Verapamil but come back if I don?t take them. Cluster cycle has not stopped yet and has been over 3 months. MRIs and MRAs have ruled out aneurysm as well as structural abnormality.
37 2021-07-20 ear infection I have had a chronic ear infection that no antibiotics have cleared up since March 2021. I had a sta... Read more
I have had a chronic ear infection that no antibiotics have cleared up since March 2021. I had a staph infection on my skin for three months and it took two rounds of antibiotic?s to clear it up.
37 2021-07-21 eye itchiness Extreme fatigue; Itchy eyes; Tingling in face; Tingly turned into burning; Face is red and itching a... Read more
Extreme fatigue; Itchy eyes; Tingling in face; Tingly turned into burning; Face is red and itching and swollen.; Face is red and itching and swollen.; Face is red and itching and swollen.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the left arm on 01Apr2021 08:15 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included lupus, rheumatoid arthritis, obesity and cold urticaria. The patient was allergic to tramadol and imuran. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN) 2.5 mg x 6, one weekly, folic acid (MANUFACTURER UNKNOWN) and multi (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 08:25, 10 minutes after injection, the patient experienced itchy eyes and tingling in face. Thought nothing of it since she could not see a rash. The patient experienced extreme fatigue 3 hours later and slept on and off. Tingly turned into burning and overnight face was red, itching and swollen. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure taken as a result of the events included antihistamines (MANUFACTURER UNKNOWN). The clinical outcome of the events itchy eyes and tingling in face, extreme fatigue, tingling turned into burning and overnight face was red, itching and swollen were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
37 2021-07-21 mouth numbness Client called nurse to report that her tongue felt numb and she had slight sob/wheezing. Client too... Read more
Client called nurse to report that her tongue felt numb and she had slight sob/wheezing. Client took two puffs of her Albuterol that she had in her car. Client complained afterwards of light headedness. Given ammonia to sniff. Client instructed to lean back in seat and lower her had. Client stated that she was feeling worse despite sniffing on ammonia. Client refused for 911 to be called, stating she wanted to go home and rest as she lived around the street. Manager came to observation site. Client said she wanted to go home. Client left with her 3 children one of whom had received the vaccine today.
37 2021-07-21 ringing in ears, deafness unilateral Pfizer-BioNTech COVID-19 Vaccine EUA: during clinic visit to establish care patient reports initial ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: during clinic visit to establish care patient reports initial flushing, body aches, fever, and headache a few hours after vaccination. A few days later patient reports facial swelling, tinnitus, and hearing loss on the left side. Patient took diphenhydramine and symptoms mostly resolved within a week. The patient was evaluated by an ENT specialist and the examination was documented as benign. Patient will continue to follow-up with ENT and allergy/immunology.
37 2021-07-26 blindness About 24 hours after receiving the first shot I had a really bad migraine. The migraine would comple... Read more
About 24 hours after receiving the first shot I had a really bad migraine. The migraine would completely debilitate me, and loss of vision, After a couple weeks of not being able to get rid of it with over counter pain meds, I went to the doctor. My blood pressure was sky high, after blood work and a hospital visit, I still have no real answers. My blood thickened I am now on a blood thinner, Several anti inflammatory medications, my heart rate is irregular and skipping a beat, my stomach and the pain in my stomach is unbearable. I was so swollen for weeks, even to walk hurt. I have so much pain in my legs and arms, I feel as though I am getting beat up daily. I have daily headaches and have not felt the same or close to it since.
37 2021-07-26 ear swelling For the first week following second dose- extreme fatigue. The first few days also included body ach... Read more
For the first week following second dose- extreme fatigue. The first few days also included body aches, nausea, and headaches. Then on July 14 I woke up in the middle of the night with pain in my left ear cartilage- it was extremely swollen, red, and hot. In 24 hours the redness and heat decreased fully and the swelling decreased a lot, however, the cartilage is still swollen and painful. I also became congested in my sinuses and developed a cough, pain in my chest, and shortness of breath. These symptoms were so bad I could not talk or walk up stairs without losing my breath and several times a day blacked out from shortness of breath or coughing. I have seen the doctor twice, was put on two inhalers, oral steroids, and tessalon perles, however, still have extreme tightness in my chest, shortness of breath, and a cough. I have not had extreme asthma symptoms requiring medical intervention in 6 years, was not exposed to anyone sick, and have not been sick in years.
37 2021-07-26 mouth tingling Approximately 8 hours after receiving the shot on 7/10/21, I had tingling that started in my right t... Read more
Approximately 8 hours after receiving the shot on 7/10/21, I had tingling that started in my right thumb (the same arm as the vaccine). The tingling spread to my fingers in the same hand, then into my right wrist, right elbow, and up my right arm. It felt like my nerves were very angry. The next day, nerve tingling started in my feet. I had jerking movements in my right lower leg. I started twitching in my arms and my legs and experienced numbness in my hands and feet. It was difficult to cut my husband's hair, because holding the hair clippers was too aggravating to the nerves in my right hand. The nerve irritation moved upward to my hips, upper legs, and low back. By Tuesday (3 days after the shot) I grew increasingly weak and stiff in my legs and back. I was also losing coordination. I went to hospital. They did tests (blood, urine, etc) which were normal. I was sent home. It was difficult to walk very far without feeling stiff. Prior to the vaccine I could walk several miles without problems. The next day, the nerve irritation moved into my upper back and neck. I felt twitching in my face. It was uncomfortable to stand for extended periods of time. Most of the symptoms subsided over the next two weeks, with some mild twitching (arms, legs), numbness (hands, feet), weakness, and coordination loss currently remaining. I took Aspirin on 7/22/21 and it caused my nerves to flare up again, causing tingling in my arms, legs, and lips. Currently on 7/27/21 I still have tingling in my hands, arms, feet, and legs.
37 2021-07-27 loss of taste, loss of smell Vaccinated on 4/2/21 and 4/23/21. Covid positive on 7/27/21. Runny nose, headache, sinus pressure, l... Read more
Vaccinated on 4/2/21 and 4/23/21. Covid positive on 7/27/21. Runny nose, headache, sinus pressure, loss of taste and smell since 7/27/21
37 2021-07-28 loss of smell, loss of smell Sx onset 7/19/21 with runny nose, nasal congestion, fatigue, headache & loss of smell. Tested on 7/2... Read more
Sx onset 7/19/21 with runny nose, nasal congestion, fatigue, headache & loss of smell. Tested on 7/23/21 which resulted as positive.
37 2021-07-28 mouth tingling I went to get my first dose of the Pfizer shoot, and during the first 15 minuter felt minor swellin... Read more
I went to get my first dose of the Pfizer shoot, and during the first 15 minuter felt minor swelling in my throat but nothing alarming. I then left the facility and 30 min later I felt strange tingling sensations in my face, and after that a numbness spread across my left side of the body. Through my arm, shoulder, neck, face and down my leg. I experienced soreness in my left calf. Even my touge was divided in two sides. Numbness was slight but feeling sense are different on each side. This has now persisted for 48 hours, and I have a slight fever. I experienced occasional pressure in my head and muscle twitches in my left calf.
37 2021-07-29 ear pain earache; Migraine; Headache; This is a spontaneous report from a contactable healthcare professional... Read more
earache; Migraine; Headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the right arm on 02Apr2021 at 16:45 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. Medical history included autoimmune inner ear disease, multiple sclerosis and shellfish allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the first day, the patient experienced headache and progressed to migraine on the second day (on 04Apr2021), then went away. On 07Apr2021, after 5 days of vaccination, the patient experienced earache. The adverse events headache, earache and migraine resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event headache and migraine was resolved on an unknown date in Apr2021 while that of the event earache was not resolved. No follow-up attempts are needed. No further information is expected.
38 2021-01-03 eye pain, eye itchiness, lacrimation increased Red itchy water painful eye
38 2021-01-03 swollen tongue Allergic reaction; Diarrhea; Chills; Palpitation; Tongue and throat swelling; Tongue and throat swel... Read more
Allergic reaction; Diarrhea; Chills; Palpitation; Tongue and throat swelling; Tongue and throat swelling; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO141), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunization. The patient's medical history included asthma and allergy. Concomitant medication included levosalbutamol hydrochloride (XOPENEX) for asthma and cetirizine hydrochloride (ZYRTEC) for allergy. About hour and a half to two hours after the vaccine, on 21Dec2020, the patient experienced had an allergic reaction with symptoms set of diarrhea, chills, palpitations, and tongue and throat swelling. The patient took diphenhydramine (BENADRYL) 25 mg as treatment. It helped some. She woke up this morning (22Dec2020) and still had the symptoms. So, she went to the emergency room. They gave her diphenhydramine 25 mg IV, methylprednisolone (SOLUMEDROL), and famotidine (PEPCID). The patient underwent lab tests and procedures which included blood count and chemistry and lab work which showed normal on 22Dec2020. Outcome of the events was unknown. The patient thinks that the product had causality to the events. Information on the lot/batch number has been requested.; Sender's Comments: The patient's medical history included asthma and allergy. Based on information available, the reported allergic reaction with symptoms set of diarrhea, chills, palpitations, and tongue and throat swelling was likely related to the use of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-01-04 dry mouth Anaphylaxis Patient was vaccinated and within just a few minutes of vaccine administration began to ... Read more
Anaphylaxis Patient was vaccinated and within just a few minutes of vaccine administration began to feel throat tightening, difficultly getting air, tachycardia, and dry mouth. Admitted to a past history of anaphylaxis with shell fish and endorses similar symptoms. Employee was treated with an epi pen and taken to the emergency room for additional monitoring and treatment as needed
38 2021-01-04 lacrimation increased, mouth numbness 5 minutes after receiving vaccine: Itchy throat Mouth numb Runny nose 30 minutes Eyes watering He... Read more
5 minutes after receiving vaccine: Itchy throat Mouth numb Runny nose 30 minutes Eyes watering Headache
38 2021-01-04 lip pain developed 2 more of the same type of sores on inside of my cheek, in mouth; sore under top lip; head... Read more
developed 2 more of the same type of sores on inside of my cheek, in mouth; sore under top lip; headache; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 12:00 PM, at left arm, at single dose for covid-19 immunization. Medical history included hepatitis c from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient was not pregnant at the time of vaccination. First day on 24Dec2020 the patient had headache and fatigue, some nausea. Day 3 (26Dec2020) and 4 (27Dec2020) headaches all day, mild. Day 5 (28Dec2020) developed sore under top lip and day 6 (29Dec2020) developed 2 more of the same type of sores on inside of my cheek, in mouth. No treatment was received for all events. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about lot/batch number has been requested.
38 2021-01-04 mouth tingling, mouth numbness tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to ... Read more
tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue; tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue; numbness and tingling progressed up my cheeks and up underneath my eyes on both sides; numbness and tingling progressed up my cheeks and up underneath my eyes on both sides; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 26Dec2020 11:30 AM at single dose for covid-19 immunization. The COVID-19 vaccine was given at nurse's hospital vaccine clinic. Medical history included narcolepsy with cataplexy. Concomitant medication in two weeks included venlafaxine hydrochloride (EFFEXOR SR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took naproxen and erythromycin; and experienced drug allergy. On 26Dec2020, the patient stated "At about 1150 my tongue started to get a little bit of numbness and tingling. I didn't really feel nervous but I thought maybe some type of anxious reaction. So I thought I'd give it just a little time and over the next 20 minutes the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue, up my cheeks and up underneath my eyes on both sides. I was not feeling anxious about the vaccination. I didn't have any trouble breathing or difficulty swallowing. It felt like Novocain that was wearing off like after you have dental work done. I decided to take 25mg Benadryl to see if it went away. And it definitely got better about 25 minutes after I took the Benadryl. Within an hour I would say it was 95% gone. Still just like a trace numbness on my cheeks. When I woke up this morning (27Dec2020) I noticed the facial numbness had completely resolved." The adverse event start time also reported as 11:45 AM. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 27Dec2020. Information on the Batch/Lot number has been requested.
38 2021-01-05 taste impairment Numbness and tingling on the injection site and the left side of your face. Also reports a metallic ... Read more
Numbness and tingling on the injection site and the left side of your face. Also reports a metallic taste in her mouth
38 2021-01-05 ear discomfort Left ear felt like it was clogged - sensation of water being in her ear; This is spontaneous report ... Read more
Left ear felt like it was clogged - sensation of water being in her ear; This is spontaneous report from a non-contactable healthcare professional (patient). A 38-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left arm, on 28Dec2020 14:00, at a single dose, COVID-19 immunization. The patient's medical history included allergies to sulfa. The patient's concomitant medication included lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28Dec2020 at 17:00, the patient's left ear felt like it was clogged - sensation of water being in her ear. This lasted a couple of days after receiving the vaccine. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event in Dec2020. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
38 2021-01-05 eye swelling Eye swelling; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female ... Read more
Eye swelling; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), on 28Dec2020 10:30AM (vaccine location: Left arm) via unknown route of administration at single dose (first dose) for COVID-19 immunization. Medical history and concomitant medications were reported none. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Eye swelling where Allergen filler was placed 7 weeks prior to the event on 30Dec2020 07:00AM. Patient did not receive any treatment. Patient did not have covid prior vaccination. Patient did not have covid tested post vaccination. The outcome of the event was not recovered. This case was assessed non-serious by reporter. The event did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
38 2021-01-05 eye swelling Headache, Body aches, swollen eyes/face, dry scratchy feeling when breathing, low grade fever I call... Read more
Headache, Body aches, swollen eyes/face, dry scratchy feeling when breathing, low grade fever I called staff with pharmacy COVID Vaccination team and notified her of the adverse reaction. The employee was seen at the medical clinic by "staff", Dr, nurse practitioner. Employee was informed that these were all common side effects + she should go ahead and take the second vaccine when it's scheduled on 1/26/21
38 2021-01-05 mouth numbness Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, f... Read more
Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, felt like it was closing up; Uncontrollable rigors; High heart rate; Numb lips and hands; Numb lips and hands; Nausea; Shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 38-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685, expiry date 30Dec2020) intramuscular (Arm Left), on 30Dec2020 09:15, single dose, for COVID-19 immunization. Relevant medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had gall bladder removed, and had tonsils removed. It was reported that the patient cannot take NSAIDS, patient was not allergic to them. No allergies to food or other products. Concomitant medications included rizatriptan and paracetamol (TYLENOL). On 30Dec2020, within about 10 minutes of the injection of the vaccine, the patient had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea. The patient was discharged from the ED, went home and took a nap. Later that evening, the patient began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath, and was admitted to the ED again and given more IV medications. Therapeutic measures given in response to the event included administration of IV medications, epinephrine injection and breathing treatment. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks, was not tested or diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events oropharyngeal discomfort, throat tightness, chills, heart rate increased, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
38 2021-01-05 pain in jaw, ear pain Left neck pain and intense left sided jaw pain (parotid gland area). The pain made it difficult to o... Read more
Left neck pain and intense left sided jaw pain (parotid gland area). The pain made it difficult to open mouth for 2 weeks, but it started getting better after week 1. The pain went into left ear.
38 2021-01-05 mouth tingling 20 minutes post immunization patient developed hives over face and neck, stated tongue felt like it ... Read more
20 minutes post immunization patient developed hives over face and neck, stated tongue felt like it was tingling, patient felt flushed and warm and stated she "just didn't feel right" patient evaluated by provider - claritin 20mg given, vitals taken after another 30 minutes of being observed patient stated she"felt better"-hives gone
38 2021-01-06 dry mouth FEELING FLUSHED, MILD FACIAL FLUSHING Narrative: 0825 C/O FEELING HOT , MILD FACIAL FLUSHING 120/84... Read more
FEELING FLUSHED, MILD FACIAL FLUSHING Narrative: 0825 C/O FEELING HOT , MILD FACIAL FLUSHING 120/84 P101 99% RA R 18 0837: 50MG BENADRYL GIVEN IM, 0841: C/O DRY MOUTH, FEELING SHAKY 0834: 124/83 P 102 99.4 100% RA 0850: C/O DRY MOUTH, COLD 0840: 118/77 P: 104 100% RA 100% RA.... 0855: 118/84 P101 100% RA T 99.0 0905: TRANSPORTED BY EMT
38 2021-01-06 eye discomfort, mouth tingling, vision blurred Facial numbness on the right side since Saturday 1/2/2020 woke up to half of my face numb the tip of... Read more
Facial numbness on the right side since Saturday 1/2/2020 woke up to half of my face numb the tip of my tongue tingled . and pressure on my right eye and I was not able to focus. I have headaches that come and go. my back is achy since last week and yesterday half of my body felt numb.
38 2021-01-06 tongue itchiness, mouth tingling Swelling of hands, throat, and cheeks. Itching/tingling back of tongue. Resolved after 45 minutes. T... Read more
Swelling of hands, throat, and cheeks. Itching/tingling back of tongue. Resolved after 45 minutes. Took Benadryl 50 mg.
38 2021-01-06 enlarged tonsils Swelling around the throat including tonsils & lymph nodes within 5 minutes of vaccine administratio... Read more
Swelling around the throat including tonsils & lymph nodes within 5 minutes of vaccine administration.
38 2021-01-07 loss of taste, pain in jaw, taste impairment Thursday morning 1/7/21, right side of face noticed jaw drooping, later progressed to bad headache, ... Read more
Thursday morning 1/7/21, right side of face noticed jaw drooping, later progressed to bad headache, bad taste in mouth then lost sense of taste. Pain on the right side of face/jaw area. Trouble speaking. Went to ER at hospital then transferred to another ER.
38 2021-01-07 dry throat Patient complained of dry, tight, scratchy throat after receiving vaccine. Patient monitored and in... Read more
Patient complained of dry, tight, scratchy throat after receiving vaccine. Patient monitored and instructed to monitor at home.
38 2021-01-07 taste impairment Taste metallic; This is a spontaneous report from a contactable health care professional (patient, a... Read more
Taste metallic; This is a spontaneous report from a contactable health care professional (patient, a Psychologist). This 38-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730) at single dose via an unknown route at left arm on 04Jan2021 15:45 for Covid-19 immunization. Medical history included sinus infection before getting the covid vaccine and this has never happened; the sinus infection was still ongoing at the moment, it started in Dec2020, she was prescribed amoxicillin for it and she was still completing it. Additional medical history included pernicious anemia, Celiac disease, Hashimoto's disease, Sulfa allergy, and Stevens Johnson syndrome. Patient also reported "she hasn't had symptoms at all". She further reported that in the past she has had a reaction to Sulfa, it was about 3 years, due to this she got Steven Johnsons' Syndrome , she was hospitalized because of this, it was not fun 0 out of 0 she would not recommend. She has had no positive test for Covid Prior to the vaccine. She has had 1 negative test, it was May2020. She had no issues with vaccines in the past. She did have an issue with the TB Test, explaining that about 6 years ago, the issue was that she got a reaction from getting the TB Test, she got dermatographic urticaria, she was instructed to never get the test again and to get X rays instead. Patient confirms allergy was to Sulfa like the antibiotic. She had no Lot or Exp it has been discarded. Concomitant drugs included ongoing amoxicillin 500mg 1 capsule by mouth twice a day from 28Dec2020 for sinus infection. Patient began to notice the metallic taste within 15 minutes of receiving the vaccine (onset date on 04Jan2021). She didn't think anything of it till she noticed it stuck around. She just had a bad taste in the mouth. It tastes weirdly metallic. Outcome of the event was not resolved.
38 2021-01-07 mouth numbness, mouth pain The next morning I woke up and thought my mouth hurt then the more I thought about it I realized it ... Read more
The next morning I woke up and thought my mouth hurt then the more I thought about it I realized it didn't hurt but it was numb on the left side, like I had Novocain wearing off. It is getting a little better but is still numb a week later.
38 2021-01-07 mouth numbness, mouth tingling, swollen tongue 1150 Post injection my tongue started to feel numb and tingling. Tongue started to swell. Over th... Read more
1150 Post injection my tongue started to feel numb and tingling. Tongue started to swell. Over the next 20 minutes the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue, up my cheeks, and underneath my eyes on both sides. Because it kept slowly progressing I took 25 mg oral Benadryl. About 20 minutes after the Benadryl I noticed that my tongue didn?t feel or look as swollen. Within an hour I would say 95% better. I just had some trace numbness on my cheeks bilaterally. Symptoms returned again about 12 hours later. Again took Benadryl, this time 50 mg. All symptoms have resolved
38 2021-01-07 mouth numbness I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart ra... Read more
I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart rate agai; uncontrollable rigors; numb lips and hands; numb lips and hands; nausea; shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable Other Health Professional (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the left arm, on 30Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had her gall bladder and tonsils removed. Concomitant medication included rizatriptan and paracetamol (TYLENOL). The patient had no known allergies but mentioned that she cannot take the NSAIDs eventhough she was not allergic to them. She had no allergies to food or to other products. It was reported that within about 10 minutes of the injection of the vaccine, she had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea on 30Dec2020 at 09:30 AM. She was discharged from the ED (emergency department), went home and took a nap. Later that evening, she began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath and she was admitted to the emergency department again and given more IV medications. The onset of the events was reported to be 30Dec2020 at 09:30 AM with outcome of recovering. As a result of the events, the patient visited that Emergency room/department or urgent care. Treatment received with IV medications (unspecified), breathing treatment, and epinephrine injection. The patient had no covid prior vaccination. She had not had Covid test post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events throat tightness, heart rate increased, chills, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
38 2021-01-07 taste disorder, mouth numbness Light headed, dizziness, pain in left arm from shoulder to elbow, fluzzy and numb feeling on roof o... Read more
Light headed, dizziness, pain in left arm from shoulder to elbow, fluzzy and numb feeling on roof of mouth, sob, constricted throat, altered sense of taste. Episode lasted for about 30 minutes. I sat and rested, focusing on my breathing and not panicking. I did not seek medical attention.
38 2021-01-07 tongue discomfort, loss of taste, mouth tingling left sided mild case of trigeminal neuritis that persisted beyond 48 hrs after vaccination given (sy... Read more
left sided mild case of trigeminal neuritis that persisted beyond 48 hrs after vaccination given (symptom-numbness); headache; gritty/sandy sensation in mouth; borderline intermittent scratchy/sore throat, gritty/sandy sensation in mouth; borderline intermittent scratchy/sore throat; lost taste; burning/tingling on tongue; burning/tingling on tongue; This is a spontaneous report from a contactable physician, the patient. A 38-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK5730), intramuscular in the left arm on 28Dec2020 at 12:30 (at the age of 38-years-old) as a single dose for Covid-19 vaccination. edical history included trigeminal neuritis in the past twice, first from herpes simplex virus (HSV1) and second from flu shot a few years ago; acne and recurrent oral HSV 1, all from an unknown date and unknown if ongoing. The patient was allergic to sulfa. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications included drospirenone, ethinylestradiol (LORYNA) for OCP; prednisone (MANUFACTURER UNKNOWN), short course completed prior to vaccination; beclometasone dipropionate (QNASL); xylometazonline hychrochloride (SUDAFED) which was stopped before vaccination; valaciclovir hydrochloride (VALTREX); ascorbic acid (VITAMIN C) which was stopped before vaccination and multivitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020 at 12:45, the patient experienced left sided mild case of trigeminal neuritis that persisted beyond 48 hours with symptoms of numbness with decreased sensation on lateral part of V2 trigeminal nerve which started 10-15 mins after vaccination with small spot corner of mouth on left and involved lateral part of entire left side of face from corner of left eye down within 1-2 hours after received vaccine. The patient also experienced headache, borderline intermittent scratchy/sore throat, gritty/sandy sensation in mouth, at 12-14 hours after getting vaccine on 28Dec2020; got burning/tingling on tongue and then lost taste 100% for about 1 hour then started to slightly come back-and waxed and waned until later that evening and most was back to normal except sweet taste still gone. The events resulted in a doctor or other healthcare professional office visit. Therapeutic measures were taken for all of the events which included antihistamines and valaciclovir; and for the trigeminal neuritis only, methylprednisolone pack. The clinical outcome of the event trigeminal neuritis was recovering (lasted longer than 48 hours after vaccination); for headache, stomatitis, throat irritation, oropharyngeal pain, ageusia, tongue discomfort and paraesthesia oral was recovered (at 48 hours after vaccination).
38 2021-01-08 feeling of choking, oropharyngeal discomfort, mouth tingling About 15 minutes after the injection I felt a warm sensation throughout my body and it went away imm... Read more
About 15 minutes after the injection I felt a warm sensation throughout my body and it went away immediately. About 10 minutes after that, my throat started feeling scratchy/itchy/tingling, then my tongue and lips. After about 10 minutes it went away. I felt ok so I left the vaccination area and went back to my department I work in. For several hours the same symptoms came and went in waves, lessening over time. At 8:30pm the same day, I took 25 mg PO Benadryl to feel safe while sleeping. I felt fine the next day and reported it to the pharmacist in the vaccination clinic. I never felt like my airway was compromised.
38 2021-01-09 chewing disorder I felt weak and with muscle fatigue the day after the shot. Also had a headache and neck muscle tens... Read more
I felt weak and with muscle fatigue the day after the shot. Also had a headache and neck muscle tension and mid back muscle tension. Joint pains as well. These subsided after 48 hours except for the neck and upper back muscle fatigue and mild soreness. This gave me a low grade headaches almost daily since the vaccine. I took ibuprofen a few times which helped. On the 6th I awoke at night and felt weak all over. I felt like I was falling in my bed. Mild dizziness. I went to work and felt extremely fatigued with muscle weakness but no neuro deficits. I feared some terrible autoimmune illness and took Decadron that day- 4mg tab BID. This helped my muscle weakness but left me with insomnia. The decadron is now wearing off after 4 days and I still have muscle weakness/fatigue. It takes considerable effort walking up the stairs. Yesterday my masseter muscles became fatigued with little chewing. My arms feel heavy when I lift them. The strange thing is that at night when I lie down I feel like my sympathetic nervous system is being triggered. I will get palpitations and feel just strange- I can't describe it. I took valium to sleep last night -5 mg tablets that my doctor gave me Saturday as there seems to be an anxiety panic component going on. I have no history of diagnosed anxiety or panic attacks- I have never felt this way before. Today I feel a little better but still have considerable muscle fatigue and neck and upper back muscle soreness and overall muscle tightness in my arms and legs- feels good to stretch kind of feeling. I have mild dizziness when standing up and turning too abruptly. But no considerable focal neuro deficits.
38 2021-01-09 oropharyngeal discomfort I felt fine after the shot all day. I went to bed at 1030pm, woke up at 1130 hyperventilating (respi... Read more
I felt fine after the shot all day. I went to bed at 1030pm, woke up at 1130 hyperventilating (respiratory rate was 40+ and I couldn?t lower it), shaking uncontrollably (felt increasingly cold, though my temp was normal; my skin was cold to the touch but I felt like it was burning off), tachycardic (heart rate was 140bpm and I normally am at 60-80 at rest). My throat felt like it was closing and my face was swollen. I should have gone to the ER, but I wasn?t thinking clearly and didn?t know what to do with my small children. It took 2 hours until I stopped shaking, my heart rate returned to normal, and my breathing was under control. Since then I have mainly been fatigued, taking Tylenol for overall aches, and have not been able to tolerate much activity (can only stand for about 5 minutes at a time).
38 2021-01-09 mouth tingling, swollen tongue Patient c/o tongue swelling, throat tingle and chest pain. Warm tingling around mouth. VS.Benadryl ... Read more
Patient c/o tongue swelling, throat tingle and chest pain. Warm tingling around mouth. VS.Benadryl 25 min 7:43, Epi Pen Eipi-Pen at 07:45, Rapid response called, Epi Pen working. Transferred to ED.
38 2021-01-09 visual field defect The patient presented with left eye peripheral visual loss, left upper and lower extremity and facia... Read more
The patient presented with left eye peripheral visual loss, left upper and lower extremity and facial numbness sensation and weakness. This started 1 hour after receiving COVID-19 vaccine at her place of employment. Pt was brought to CRMC via EMS.
38 2021-01-10 loss of taste Fever up to 101.2 F, chills, severe headache( left temporal, right temporal then spread to forebrain... Read more
Fever up to 101.2 F, chills, severe headache( left temporal, right temporal then spread to forebrain, even walking coughing makes brain hurt like tingling, loose stool, long bone pain, peri orbital edema, neck stiffness, new onset low back, loss of appetite, loss of taste, insomnia, fatigue and dizziness. I feel like I have all repeat symptoms of covid, with worse headache and neckstiffness than actual infection. Fever last for 3 days and disappeared but headache continues and ended up in ER. CTA negative, D dimer<200
38 2021-01-10 taste impairment Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for severa... Read more
Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for several hours, racing heart rate, sudden hot feeling, extreme headache, extreme fatigue, brain fog, irritability, pain at injection site.
38 2021-01-10 eye swelling Swollen left under eye noted at 0500 the morning after the vaccine where fillers are in. Prednisone... Read more
Swollen left under eye noted at 0500 the morning after the vaccine where fillers are in. Prednisone and zyrtec started and swelling has improved however 1 more day left of medications.
38 2021-01-10 mouth numbness, taste impairment Metallic taste in the back of throat between 15-20 minutes post vaccination, noticeable swallowing a... Read more
Metallic taste in the back of throat between 15-20 minutes post vaccination, noticeable swallowing and throat irritation at 20-25 minutes post vaccination, tongue and lip numbness and throat tightness at 25-30 minutes, dry hacking cough at 30 minutes. Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions, coughing, speaking 1-2 word sentences, with tachycardia and tachypnea. Treated with IM epinephrine, IV solumedrol and IV Benadryl and IV Benadryl with marked improvement in symptoms.
38 2021-01-10 swollen tongue Wheezing, cough, tongue swelling
38 2021-01-10 vision blurred chest tightness, trouble breathing, dizziness and blurry vision
38 2021-01-10 vision blurred SCRATCHY THROAT , BLURRY VISION, LIGHTHEADEDNESS. SOLUMEDROL, BENADRLY, PEPCID. 1 LITER OF FLUIDS.
38 2021-01-11 eye itchiness Two days after receiving 2nd dose of COVID19 vaccine, red itchy areas to upper legs and arms. Progre... Read more
Two days after receiving 2nd dose of COVID19 vaccine, red itchy areas to upper legs and arms. Progressed next day. Today 1/12/21 employee showed me additional red areas to arms, face, outer eyes and states red areas to abdomen. Otherwise feels well.
38 2021-01-11 eye swelling Facial cellulitis, eye swelling, headache, nausea
38 2021-01-11 lip swelling, burning mouth syndrome, swollen tongue, pain in jaw Became very hot, flushing, dizziness, lightheaded, felt like passing out. Followed by jaw tightness ... Read more
Became very hot, flushing, dizziness, lightheaded, felt like passing out. Followed by jaw tightness and pain, tongue swelling, lip swelling, difficulty breathing, chest tightness, fast heartbeat, increased blood pressure. Given benadryl, epi, solu-medrol and pepcid. Kept for observation. After release, continuing to have intermittent hot flashes, itching all over face and body, occasional jaw tightness, sore throat and tongue, increase in pulse, O2 sats in low 90s,
38 2021-01-11 lip swelling R sided facial numbness approx 30 mins after vaccine. R lip felt swole/big then R lower face. I took... Read more
R sided facial numbness approx 30 mins after vaccine. R lip felt swole/big then R lower face. I took 1/2 Benadryl after.
38 2021-01-11 oral mucosal blistering I had body ache, fever, vomiting, a nausea. It lasted for 3 days. I went to doctor. I receive bliste... Read more
I had body ache, fever, vomiting, a nausea. It lasted for 3 days. I went to doctor. I receive blister on my mouth. I was in bed and couldn't take anyting.
38 2021-01-11 mouth tingling Experienced tingling of tongue and lips 20 minutes after injection of vaccine. Zyrtec 10mg PO give... Read more
Experienced tingling of tongue and lips 20 minutes after injection of vaccine. Zyrtec 10mg PO given, with symptoms resolved after 35 minutes.
38 2021-01-12 swollen tongue, mouth tingling Patient vaccinated at 1715. Almost immediately after vaccination patient experienced dizziness and ... Read more
Patient vaccinated at 1715. Almost immediately after vaccination patient experienced dizziness and tongue tingling. Diphenhydramine 50 mg IM was administered at 1726. Patient progressed to swollen tongue and inability to swallow. Epinephrine 0.3 mg IM administered at 1800. Patient transported to ED. In ED patient received fluids, famotidine 20 mg at 1840, and dexamethasone 12 mg IV at 1858. Patient symptoms resolved and she was discharged.
38 2021-01-13 ear pain Fever of 101.5° f, headache, chills, body ache, joint pain, inner ear pain in both ears and swollen... Read more
Fever of 101.5° f, headache, chills, body ache, joint pain, inner ear pain in both ears and swollen painful lymph node around collarbone on left side. Collarbone areas are visibly different due to swelling. Most symptoms resolved within 36 hours of second dose of Pfizer vaccine. However, swollen lymph node in left clavicle area has continued to get more painful and swollen. Will seek medical treatment if this does not resolve.
38 2021-01-14 dry throat dry, tight, scratchy throat; dry, tight, scratchy throat; dry, tight, scratchy throat; This is a spo... Read more
dry, tight, scratchy throat; dry, tight, scratchy throat; dry, tight, scratchy throat; This is a spontaneous report from a contactable pharmacist. A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) intramuscular on 06Jan2021 18:15 (06:15 PM) at a single dose for COVID vaccine. Medical history included anxiety; known allergies to latex, penicillin, wheat, gluten. Concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. It was unknown if the patient received other vaccines within four weeks prior to the COVID vaccine and there were no documented other medications within 2 weeks of vaccination. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). On 06Jan2021 18:15, the patient complained of dry, tight, scratchy throat after receiving vaccine; assessed as non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient was monitored and instructed to monitor at home. Treatment was not received for the events. It was unknown if she was diagnosed with COVID-19 prior to vaccination and also unknown if she had COVID-19 tested post vaccination. The outcome of the events was unknown.
38 2021-01-16 dry mouth, swollen tongue Allergic reaction started about 30-35 minutes after injection. First symptom was dry mouth, tickle i... Read more
Allergic reaction started about 30-35 minutes after injection. First symptom was dry mouth, tickle in throat, and felt like tongue was swelling followed by hot flashes, ?cloudy? brain. My words didn?t want to form although I knew what I wanted to say. I was speaking very slowly. Heart rate was fast.
38 2021-01-17 ear pain Vaccination on 1/6/2021. Pt noticed pain behind her R ear on 1/11/2021. Pt then noticed right-sided... Read more
Vaccination on 1/6/2021. Pt noticed pain behind her R ear on 1/11/2021. Pt then noticed right-sided facial weakness and asymmetry on 1/12/2021. Pt went to ED for evaluation. Pt diagnosed with Bell's Palsy and given Valacyclovir and prednisone to be taken orally for 7 days and referred to Neurology for ongoing care.
38 2021-01-17 feeling of choking Throat tickling.
38 2021-01-18 ear discomfort, hearing loss, ear pain 12/30- possible exposure to COVID (+) med student 1/5- tested negative 1/8- tested negative, went t... Read more
12/30- possible exposure to COVID (+) med student 1/5- tested negative 1/8- tested negative, went to clinic and was diagnosed with a head cold, BP elevated 1/9-1/10- had 100.1. fever, lethargic, high BP, lymph nodes swollen 1/12- BP uncontrolled, Increased metoprolol to 2 pills instead of 1 1/15- noticed pressure on L side of neck, temp higher on this side compared to right 1/17- L earache, decreased hearing, feels clogged, pain intermittent
38 2021-01-18 lip swelling Swollen lower lip about 24 hours after receiving 2nd dose of vaccine
38 2021-01-18 sensitivity to light Received dose at 1205 noon on January 15, 2021. I completed the 30 minutes after vaccination due to ... Read more
Received dose at 1205 noon on January 15, 2021. I completed the 30 minutes after vaccination due to history of food allergies/medication allergies/intolerances and is prescribed epinephrine. After 30 minutes no reaction was seen in return to work, as a healthcare, CMA. At 1500 hrs. became incredibly dizzy, flushed, hot sweats. Sat down with cool window open, facecloth. Legs became tingling and numb, blood pressure was taken at over 130/90, nausea increasing, could not keep eyes open due to dizziness and light, with headache developing. After 30 to 45 minutes of observation from healthcare staff/coworkers became incredibly weak in arms and legs, head became incredibly faint, nausea increased, headache, dizziness, extreme fatigue in regards to wanting to sleep. At which time clinical lead nurse/supervisor brought myself to emergency room department for further evaluation. Was brought into emergency room for further evaluation developed at this time a lump in throat feeling, and was given an IV of Benadryl 25mg and Pepcid 20mg with an hours of observation. Within an hour of observation extreme fatigue tingling numbness and dizziness head decreased. And was discharged from emergency room for vaccine reaction around 20:00. Home with Benadryl 25 mg and Pepcid 20 mg, 3 times daily to treat reaction. After reaction been dealing with headaches and nausea.
38 2021-01-19 lip itchiness, swollen tongue, lip swelling, enlarged tonsils, tongue itchiness 11 minutes after receiving shot, scalp on head started itching, tongue started swelling, area around... Read more
11 minutes after receiving shot, scalp on head started itching, tongue started swelling, area around tonsils felt like it was swelling. Pt received epi, and lips/tongue/throat continued to swell and itching spread to different parts of face.
38 2021-01-19 mouth discomfort Felt hot, flushed, tingling. Then mouth and throat started to burn. Throat felt like closing. Diffic... Read more
Felt hot, flushed, tingling. Then mouth and throat started to burn. Throat felt like closing. Difficult to swallow water. Able to take Benadryl liquid within 5 minutes of reaction starting and drink water (4 bottles of 16 ounces). 15 minutes later felt returning to normal status. No epinephrine used.
38 2021-01-19 mouth tingling Patient describes a tingling in her tongue, this is the same reaction she gets with exposure to her ... Read more
Patient describes a tingling in her tongue, this is the same reaction she gets with exposure to her other allergens including: grapes, blueberries, and dust. The patient was given 50mg Benadryl and monitored for 1.5 hours. The patient did not report a gradual lessening of symptoms. Patient will be released with instructions for self monitoring and emergency planning if the symptoms get worse. She has had no history of EPI usage for an allergic reaction. She has gone for the
38 2021-01-19 feeling of choking Twenty minutes after injection patient noted left sided facial numbness (Same side as injection). Sh... Read more
Twenty minutes after injection patient noted left sided facial numbness (Same side as injection). Shortly after that she noted some tingling in her throat. She was given diphenhydramine 50mg and monitored for roughly 1 hour total after her injection before having complete resolution of the tingling in her throat and marked improvement in facial numbness.
38 2021-01-20 eye movement disorder Prior to vaccination, patient denied previous reactions to vaccines or injectable products. Patient ... Read more
Prior to vaccination, patient denied previous reactions to vaccines or injectable products. Patient received Pfizer COVID-19 vaccine at approximately 10:55 am. Patient requested to sit down as she became faint. After sitting, patient became unresponsive with eyes rolling back in head, and gasping for breath/gurgling. Patient's head was also bobbing up and down slightly. Patient was then transferred to the floor. After moving to the floor, patient became slightly responsive but was still disoriented. 0.3 mg of epinephrine was administered into the right thigh at approximately 11:04 am. Patient's condition continued to improve, although she became nauseous with no emesis. EMS arrived at the scene and patient was monitored in the ambulance per EMS discretion but then left the scene with her husband.
38 2021-01-20 extreme sound sensitivity, sensitivity to light Mild nausea; Flu-like symptoms; headache; mild dizziness; mild brain fog mid afternoon; having some ... Read more
Mild nausea; Flu-like symptoms; headache; mild dizziness; mild brain fog mid afternoon; having some sensitivity to sound and light; having some sensitivity to sound and light; I'm suspecting this may be triggering a migraine; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for herself). A 38-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL1283, expiry date not reported), via an unspecified route of administration on 09Jan2021 07:00 at a single dose on the left arm for COVID 19 immunization. Medical history included GERD (gastrooesophageal reflux disease), migraines, and indoor allergies. The patient was not pregnant at the time of the vaccination. The patient had no Covid prior to vaccination. Concomitant medication included mometasone furoate (FLONASE), taken within two week prior to vaccination. The patient previously took codeine and was allergic to it; and flu vaccine and experienced intolerance and short term dizziness. Patient had first dose of Pfizer COVID 19 bnt162b2 as COVID 19 immunization on 19Dec2020 at 07:30 AM, intramuscularly on the left arm. No other vaccines were taken in the four weeks. Patient received second Pfizer dose on Saturday (09Jan2021) at approximately 7:00am. Consistent with prior history of dizziness following flu vaccines, patient started to develop mild dizziness and mild brain fog mid afternoon (reported as 09Jan2021 11:30). Flu-like symptoms and headache started around 8:00pm and resolved around 6:00pm on Sunday (the following day; 10Jan2021). Mild nausea also experienced Sunday morning (10Jan2021). Unfortunately, patient was still experiencing dizziness and brain fog that comes and goes and was worse midafternoon. Patient was having some sensitivity to sound and light, and suspecting this may be triggering a migraine since 09Jan2021 11:30. As treatment to the reported events patient received Aleve. The patient was not tested for COVID post vaccination. The patient recovered from flu-like symptoms and headache on 10Jan2021 18:00. The patient had not recovered from mild dizziness, mild brain fog, mild nausea, some sensitivity to sound and light and migraine.
38 2021-01-20 extreme sound sensitivity Tremendous body aches. Skin sensitivity. Sound created body pain waves. Fatigue. Mild nausea. 9 pm T... Read more
Tremendous body aches. Skin sensitivity. Sound created body pain waves. Fatigue. Mild nausea. 9 pm Tuesday through 5 pm Wednesday.
38 2021-01-20 mouth tingling Patient began to have tongue tingling and an elevated heart rate about 45 minutes after receiving th... Read more
Patient began to have tongue tingling and an elevated heart rate about 45 minutes after receiving the 1st dose of the Pfizer vaccine. She was given 50mg Benadryl IM. Her tongue tingling resolved after 30 minutes.
38 2021-01-20 swelling around the eyes Patient received her second dose of the Pfizer COVID vaccine in the right arm 45 minutes ago. She wa... Read more
Patient received her second dose of the Pfizer COVID vaccine in the right arm 45 minutes ago. She was being monitored for the mandatory 15-30 minute period when she started feeling some increasing shortness of breath, scratchy throat, some swelling in her bilateral periorbital area. She was then taken to the ED for further evaluation. Patient denies any allergic reaction to the initial covid vaccine 3 weeks ago. She denies any abdominal pain, diarrhea, nausea, vomiting, chest pain, shortness of breath. She does have a mild headache. In ED, patient received diphenhydramine 25mg IV, epinephrine 0.3mg IM, famotidine 20mg IV and dexamethasone 10mg IV, and LR 1,000mL bolus @ 1228, ketorolac 15mg @1312, ondansetron 4mg @1312. Patient monitored and discharged at 1530.
38 2021-01-20 swelling around the eyes Patient received her second dose of the Pfizer COVID vaccine in the right arm 45 minutes ago. She wa... Read more
Patient received her second dose of the Pfizer COVID vaccine in the right arm 45 minutes ago. She was being monitored for the mandatory 15-30 minute period when she started feeling some increasing shortness of breath, scratchy throat, some swelling in her bilateral periorbital area. She was then taken to the ED for further evaluation. Patient denies any allergic reaction to the initial covid vaccine 3 weeks ago. She denies any abdominal pain, diarrhea, nausea, vomiting, chest pain, shortness of breath. She does have a mild headache. She received IM epinephrine, diphenhydramine, famotidine, and dexamethasone at 1300 and was monitored and discharged at 1530.
38 2021-01-20 vision blurred I got the vaccine at 11am on 1/19/21 by 8pm of 1/19/21 I had a low grade temp and was tired so I wen... Read more
I got the vaccine at 11am on 1/19/21 by 8pm of 1/19/21 I had a low grade temp and was tired so I went to bed. By 1am I woke up with uncontrollable shivering and had an alarming temperature of 104. I then took alternating Tylenol and ibuprofen and for the next 24 hours and I had a continuous fever for the entirety of 1/20/21 that would range from 101-103 with taking the constant Tylenol and ibuprofen. In addition I had shooting nerve pain down my legs, I was so weak I felt like I could not move, terrible body aches, and had what felt like dizziness and blurred vision at the same time. By 1/21/21 I started to improve but still had an increased temp of 99 and body aches but not as bad as the day prior. I am a healthy 38 year old with a good BMI no medical history and am very concerned about the temperature of 103-104 in regards to those with underlying heart or health conditions which may not be able to withstand that high of a temperature or a continuous temperature like I had for an extended period of time . I would have gone to the emergency room but I am a healthcare professional with the education and experience to know what to do in this situation
38 2021-01-21 eye floaters About 9 am on 1-21-2021 started to ?feel off?, between this time and 11am I would get light headed ... Read more
About 9 am on 1-21-2021 started to ?feel off?, between this time and 11am I would get light headed at random. At 11am I started to see ?black floaters? and developed a slight headache. Coworker (another ICU RN) took blood pressure: 234/148 and tachycardia. Was made to rest while arrangements could be arranged and given 4 chewable baby aspirin. Was then sent to urgent care.
38 2021-01-22 pain in jaw Leftside sudden onset jaw pain. Jaw pain 7 out of 10. Left arm discomfort to injection site 2 of 10... Read more
Leftside sudden onset jaw pain. Jaw pain 7 out of 10. Left arm discomfort to injection site 2 of 10. Left jaw pain is constant ,achy, and at times throbbing. Unable to close mouth all the way on left side. Unable to chew food due to pain. Received vaccination at 3:10pm and the sudden onset pain started at 8pm the same day. Meds taken: Tylenol, ibuprofen, and benadryl. All meds have been un effective to help control pain. Ice and heat have been un effective for jaw pain. Ice has been effective for injection site pain.
38 2021-01-24 ringing in ears The day following the 2nd vaccination dose, I had zero symptoms other than a slightly sore injection... Read more
The day following the 2nd vaccination dose, I had zero symptoms other than a slightly sore injection site. Around hour 30 following the vaccination I began to feel warm, and I got up to brush my teeth and cool off in the bathroom. As I was brushing my teeth, I started experiencing an increasing ringing noise in both my ears that I thought was strange and somewhat alarming, but I didn't feel any signs of dizziness or dysphoria. The next thing I remember is waking up the bathroom floor with my husband standing over me. Apparently I experienced a complete lose of consciousness and feel to the floor, hitting my chin on the bathroom vanity as I feel and splitting my chin open, which I have zero recollection of. My husband states that when he found me, that my eyes were open, but I was staring blankly at him with a glazed over look and my whole body was limp and diaphoretic. I came too in about 30 seconds after he found me, but I was very confused, not making a lot of sense, and felt very disoriented and weak. It took about 20 mins for my fever to break, and to have the strength and power to get up and walk to bed. We changed all my clothes because I had soaked through them, and he got me into bed after cleaning/bandaging up my chin. I then slept solidly until noon the next day, which is very unlike me, but since then I have felt relatively fine with no other experiences of fever/chills/disorientation, just some continued mild fatigue off and on. After discussing with my nursing colleagues, they all had similar experiences around hour 24-30 post 2nd vaccine with fevers, chills, restless sleep, or just general malaise, but no one experienced a complete loose of consciousness, so I reached out to my PCP yesterday, and she confirmed today that I should report this to VAERS. I have never experienced any form of loss of consciousness/fainting/black-out/syncope prior to this, which is another reason I thought it was important for me to report this.
38 2021-01-25 loss of taste, loss of smell First it was dizziness, light headed, nausea, and vomiting, headaches, and extreme weakness. Went to... Read more
First it was dizziness, light headed, nausea, and vomiting, headaches, and extreme weakness. Went to the Hospital received IV fluids and sent home. Wasn't any better and lost my taste and smell for 3 days. Went to the Clinic, was tested for Covid-19 and the flu both negative. Went back to the Clinic and had chest x-ray, diagnosed with right middle lobe pneumonia. Sent home with doxycycline and zofran. Took the Medication as directed. Still feeling dizzy and lightheaded, and still winded and extremely tired after doing the slightest bit of house work, whether it would be sweeping the floor, doing dishes, or laundry. I get extremely after doing one activity. I still have not driven.
38 2021-01-25 mouth tingling, mouth numbness Tingling, numbness of lips, inside cheek and tongue for approx. an hour. Given oral 50mg benadryl a... Read more
Tingling, numbness of lips, inside cheek and tongue for approx. an hour. Given oral 50mg benadryl at 1025, nothing progressed or got worst.
38 2021-01-25 mouth tingling Tingling in left check
38 2021-01-26 loss of taste, loss of smell At the vaccination day only soreness at the injection site. I started feeling bad on 12/27/20 with a... Read more
At the vaccination day only soreness at the injection site. I started feeling bad on 12/27/20 with a sore throat. Monday I had a bit of sinus congestion and Tuesday 12/29/20 no sense of smell or taste. I was tested that day on 12/29/20 and was positive.
38 2021-01-26 blindness Shot recieved Wednesday. By Wednesday night, I had a headache (forehead and back of neck) and fatig... Read more
Shot recieved Wednesday. By Wednesday night, I had a headache (forehead and back of neck) and fatigue. Friday I became dizzy, and had 2 near fainting spells (this included dizziness, weak muscles, and slight loss of sight). I became achy (back and shoulders) and my headache continued. These dizzy spells and headaches have continued for 6 days. The dizziness is starting to subside, however the headache and fatigue remains.
38 2021-01-26 taste impairment, loss of taste Nausea; vomiting; Metallic taste; Headache; migraine; didn't have an appetite; lost taste, lost the ... Read more
Nausea; vomiting; Metallic taste; Headache; migraine; didn't have an appetite; lost taste, lost the sense of taste; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported a 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176) via unspecified route single dose for COVID-19 immunization on 08Jan2021, 10 am, at 38-year-old. Medical history was not reported. Concomitant medication included: celecoxib (CELEXA) 10 mg for an anti-depressant; alprazolam (XANAX) 0.25mg three times a day. Once the patient took that second vaccine, she had the metallic taste and had some headache and migraine at that time (08Jan2021). When the patient got the vaccine, within one minute, she started getting her usual migraine on the right side of head (08Jan2021), that was pretty much instantly. She didn't have an appetite (Jan2021), she only vomited when she ate. She had nausea and vomiting, it was about 2 o'clock that afternoon (08Jan2021, 2 pm). Every time she ate, she vomited and lost taste, lost the sense of taste. The patient was still nauseated (Hence, ongoing checked for nausea) and she hadn't tasted anything. She hadn't drink or ate anything yet this morning but last night her taste was starting to come back. But she still couldn't identify something. No treatment received. Action taken for BNT162B2 was not applicable. Outcome of the event nausea was not resolved, outcome of the other events was unknown.
38 2021-01-26 ear pain severe dizziness; disorientation; Tired; muscle aches; L ear pain; chills; This is a spontaneous rep... Read more
severe dizziness; disorientation; Tired; muscle aches; L ear pain; chills; This is a spontaneous report from a contactable Other HCP (patient). A 38-year-old female (pregnant: No) patient received 1st dose of BNT162B2 (COVID vaccine, lot number= EK9231) on 11Jan2021 12:30 PM on Left arm for covid-19 immunization. Medical history and concomitant drug were not reported. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Patient experienced severe dizziness, disorientation, unable to finish any tasks. Tired, some muscle aches, L ear pain and chills (no fever) on 11Jan2021 01:00 PM. No treatment. Outcome of the event was Recovered/Resolved with Sequel. No further information is expected. Information on the Batch/Lot number has been obtained.
38 2021-01-26 mouth tingling Within 2 minutes of receiving vaccine, patient reported experiencing throat swelling, face and lip t... Read more
Within 2 minutes of receiving vaccine, patient reported experiencing throat swelling, face and lip tingling. Patient was administered diphenhydramine PO while in clinic. At this time, patient declined to be seen in the ED and was released from clinic after additional monitoring. Patient received a course of prednisone from another physician later that day. 2 days later the patient began experiencing severe abdominal pain and was seen in the ED. Labs, right upper quadrant ultrasound, and abdominal CT were within normal limits and was determined that symptoms were likely still part of COVID vaccine anaphylactic reaction. The patient was evaluated by the acute care surgery service who did not find anything concerning and was discharged home from the ED with return precautions and instructions to follow-up with primary physician. The patient follow-up with PCP and was continued on a 5 day course of steroids. The patient will not receive a second vaccine dose at this time and was referred to see an allergist for further testing.
38 2021-01-26 mouth tingling Pt called office on 1/14/2021 and reported that she had her second Pfizer Covid 19 immunization. s... Read more
Pt called office on 1/14/2021 and reported that she had her second Pfizer Covid 19 immunization. she reported having some periorbital edema, facial rash (located underneath her protective face mask) and tingling around her lips. She had self medicated with some cetirizine . we provided her an injection of solumedrol IM. Symptoms resolved.
38 2021-01-27 taste impairment Post vaccine, patient described chest pain, metallic taste in mouth, dry tongue and L foot tingling.
38 2021-01-27 mouth tingling, taste impairment, taste impairment, mouth numbness, mouth tingling, mouth numbness Immediately after receiving the vaccine, patient noticed that she had a metallic taste in her mouth.... Read more
Immediately after receiving the vaccine, patient noticed that she had a metallic taste in her mouth. Approximately 4 minutes later she called the attention of a staff member to alert them that her tongue felt tingly. The RN was called to come observe patient, blood pressure taken at this time, reading was 118/82. Patient began complaining that mouth and tongue both felt numb and it was becoming hard to swallow. EMS was called at this time along with MD. MD directed nurses to continue to monitor patient, while on the phone with MD, patient stated that her chest felt heavy. MD ordered patient to receive 0.5 ml of Epinephrine. Patient received dose of epinephrine. BP taken again at 1:18, 3 minutes after Epi injection, reading was 124/86. Patient began complaining of a "heaviness feeling" in legs at approximately 1:19. Ambulance and EMS staff arrived at 1:21. Ambulance left with patient at 1:26. Spoke with patient at 4:45 pm, patient has made a full recovery and is at work.
38 2021-01-27 mouth tingling, taste impairment Dose #1 4 hours later tingling on my tongue and a strange taste almost metallic which lasted 5 days,... Read more
Dose #1 4 hours later tingling on my tongue and a strange taste almost metallic which lasted 5 days, I woke up on 12/31/20 with body aches, chills, headache, that is when I called the infectious disease nurse and they tested me for covid on the 31st and it was negative, I also approximately 2 weeks after the dose i developed a large red bullseye around the injection site and it lasted about 3 days. I had some itching and swelling at the injection site but the bullseye showed up later. The infectious disease team did not seem to find I needed any additional treatment. I self medicated myself with Tylenol, Benadryl Zyrtec OTC and Ibuprofen. There was about 4-5 days before the second dose when the symptoms cleared up.
38 2021-01-28 mouth ulceration, mouth pain I got multiple very painful ulcers on the roof of my mouth and just behind my right front tooth.
38 2021-01-28 vision blurred, eye pain, sensitivity to light, eye strain, eye discomfort nasty headache; felt hot; Shivers; achy; Nauseous; eyesight/ felt like she was straining; sensitivit... Read more
nasty headache; felt hot; Shivers; achy; Nauseous; eyesight/ felt like she was straining; sensitivity to light; eyeballs felt sore; cold sweats; when she talked, she felt like she had to close her eyes because of pressure; arm was hurting really bad; received the 2nd vaccine yesterday/ date of the first vaccine was 28Dec2020; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on the left arm, deltoid on 14Jan2021 15:30 to 14Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included ongoing pernicious anaemia, a B12 deficiency diagnosed 2-3 years ago (she gave herself B12 shots and she cannot convert B12 through her food), and myomectomy (15 cm uterine fibroid, removed this past summer). Concomitant medication included ongoing cyanocobalamin (B12) for pernicious anemia. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on the left arm, deltoid on 28Dec2020 at a single dose for COVID-19 immunization; and a flu shot (the MA gave it in the back of her arm, it was pretty significant). The patient was a nurse and informed that she received the second COVID vaccine the day before report (14Jan2021). She woke up on the day of report on 15Jan2021 03:00 with a nasty headache, she felt hot, had the creepy crawly shivers, was achy and when she talked, she felt like she had to close her eyes because of pressure, and she was nauseous. She figured this was probably normal but she couldn't get a hold of her doctor and the hospital she worked at did not know what to tell her. She was wondering if she can take Tylenol or ibuprofen and has even thought about drinking caffeine, that it might help her headache. She didn't have a prescribing doctor as she got it at work. The first round of the vaccine she only had a super mild sore arm and a slight headache. She received the second vaccine at 3:30pm and then went to bed when she got home. She woke herself up at 3 am because her arm was hurting really bad. She started feeling like she couldn't keep her legs still. She felt hot, achy, and was shivering. She hasn't taken her temperature. When she woke up at 3 am she got on her phone, and her eyesight felt like she couldn't quite focus. It wasn't bad, but she felt like she was straining. Then her head started hurting at 5-7 am. She was very sensitive to light. She woke up and couldn't go back to sleep. She had cold sweats, and was shivering. Every time she stood up, she was chattering. She felt achy almost like growing pains. She woke up with the arm pain, and then 10-15 minutes later, she started feeling that creepy crawly feeling. She got up and the cool fan hit her, and she realized how bad she was shivering. The shivering intensified at times but hasn't gotten worse. She had just called employee health and realized that when her eyes were open when she was talking was when she felt nauseated. She has noticed the nausea in the past half hour. She did not know if it was related to the headache or what. She had to cover her eyes, her eyeballs felt sore. When she talked with her eyes open, she felt a little queasy. She was just straining to see. Her vision was not blurry but she can tell she was straining. She did not know if it was because of the headache and nausea. When she got out of bed, the cold fan did not feel cold but it made her shiver. She was a nurse was trying to be socially responsible as she did not want to get COVID. She was a little suspicious because of the headache after the first one. She hasn't been around anyone in a couple of weeks and had been working from home. She has not been exposed to people. She kept feeling like she needed to stretch because she was sore. The patient was tested for COVID pre-surgery (myomectomy) and was negative. She was also tested for COVID antibodies and she did not have any. She was vaccinated at a hospital facility. Patient received no other vaccines on that day. The adverse events did not require any visit to the emergency room or physician office. Patient did not receive prior vaccines in the previous 4 weeks. Outcome of the events cold sweat and "tested for COVID antibodies and she did not have any" was unknown, nasty headache was reported as worsened (not recovered), and the remaining events was not recovered. The reporter considered the events serious due to medically significant events and related to the suspect drug.; Sender's Comments: Based on the information currently available, a possible contributory role of BNT162B2 vaccine in the development of the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-01-29 mouth tingling Itching at injection site which spread to bilateral arms, legs and abdomen 4 minutes following injec... Read more
Itching at injection site which spread to bilateral arms, legs and abdomen 4 minutes following injection. 50mg Benadryl PO administered to patient by co-workers in LTC facility. HR 108, SaO2 98%, 5 min following injection. Dizziness began 11 minutes following vaccine injection. Patient laid in bed with elevated head. HR 80, SaO2 98% 15 minutes following injection. Tingling in lips mouth area began 30 minutes following vaccine injection. 911 called within 2 minutes of this and EpiPen 0.3mg dose administered at same time in left thigh. HR 94, SaO2 98% 32 minutes following vaccine injection. Ambulance arrived and patient stable, stating reduction in tingling of lip/mouth area and reduction in overall body itching. Patient taken to ER, based on history of allergy to fish, and patient's agreement to be seen in ER.
38 2021-01-29 ringing in ears 38 year old female observed post 1st COVID vaccine @ 1:18PM. 5 minutes post vaccine patient report... Read more
38 year old female observed post 1st COVID vaccine @ 1:18PM. 5 minutes post vaccine patient reported tinnitus, itchy throat, dizziness and neck/face flush. On exam lungs clear, BP and O2 stable, HR 102 BPM. Patient was administered Benadryl PO and observed. 10 minutes post benadryl patient became tachycardic and reported chest tightness and shortness of breath, patient was then administered EPIPEN to Left outer thigh. EMS activated and patient was sent to ER
38 2021-01-31 dry mouth, dry throat Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations,... Read more
Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations, fever, dizziness, a dry mouth/throat and heat in my head/upper body. After being discharged from recovery an hour later i returned home but felt very anxious all night. Heart palpitations continued on and off. Day 2: Severe cramp/pain started in my arm, neck and shoulders. Headache. Sweating. Days 3 & 4: Flu symptoms; headache, shivers/fever, runny nose, sore throat, cough, severe muscle and joint pain. Skin was so sensitive to touch i could not wash. Muscles hurt so much i could not move around. Extreme fatigue. Days 5 & 6: Cold symptoms started to resolve. Muscle and joint pain still very severe - difficulty walking/moving around, stiffness and aches in every part of my body. Extreme fatigue. Days 7, 8 & 9: Cold symptoms gone. Muscle and joint pain still severe. Extreme fatigue. Day 10: Pain in muscles started to resolve but not in joints. Fatigue still present. Day 11: Fatigue starting to resolve, joints still very sore.
38 2021-01-31 mouth tingling Congestion started the night of 1/29/21. The next morning on 1/30/21 she started to get tingling in ... Read more
Congestion started the night of 1/29/21. The next morning on 1/30/21 she started to get tingling in both arms, facial swelling, face became tingling and flushed feeling. Slight tingling in tongue. She took Benadryl with mild relief. No shortness of breath or difficulty swallowing. Tingling of tongue and arms is gone but still has facial swelling and redness.
38 2021-02-01 bleeding gums Had finished me struck period the week prior to second shot. Day after second re-started menstrual p... Read more
Had finished me struck period the week prior to second shot. Day after second re-started menstrual period, and still bleeding today. Also noticed bleeding gums and bloody noses shortly after second vaccine. (Have never experienced these prior to second vaccine)
38 2021-02-02 thirst Headache and interstitial pain starting the evening of dose 2 injection, generalized body aches, jo... Read more
Headache and interstitial pain starting the evening of dose 2 injection, generalized body aches, joint pain (hips, shoulders, metacarpal/phalange, knees) starting shortly after midnight after injection for about 28hrs. Day 2 post injection significant brain fog through 48hrs post injection. Day 3 fog lifting gone by about 72 hrs post injection. Increased thirst throughout.
38 2021-02-03 mouth numbness, mouth tingling Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and... Read more
Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and chest; Slight itching; This is a spontaneous report from a contactable healthcare professional (the patient). A 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular in the left arm on 18Jan2021 at 10:30 (at the age of 38-years-old) as a single dose for Covid-19 immunization. Medical history was not reported. The patient was allergic to penicillin. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685) on 28Dec2020 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ALERTEC), both for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jan2021 at 11:00, the patient experienced bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching. Treatment was given when seen by paramedics with an emergency room visit which included a second dose of allergy medication. The clinical outcome of the events bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The reported events were likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering the plausible temporal relationship and clinical course of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-02-03 eye discomfort, eye strain Pt received vaccine at 1645. Pt sitting in observation for 15 min post vaccination. After 13 minutes... Read more
Pt received vaccine at 1645. Pt sitting in observation for 15 min post vaccination. After 13 minutes patient reports dizziness, fatigue, eye lids are getting heavy with pressure, throat with burning sensation, difficulty breathing and clearing throat. At 1700 patient given Benadryl 25mg PO and obs for 1 hr. Symptoms resolved.
38 2021-02-03 swollen tongue swelling of tongue improved with benedryl
38 2021-02-03 swollen tongue EMT found Pt in vaccine observation area, sitting in chair. At 2:12 pm (15 min after vaccination). P... Read more
EMT found Pt in vaccine observation area, sitting in chair. At 2:12 pm (15 min after vaccination). Pt c/o scratchy, swollen throat, feeling warm, pain in neck, light headed, nausea. Vitals taken at 2:19 pm: BP 146/100, HR 112, respirations 20. Pt AxO x4, still talking, no SOB or complaints of breathing, no wheezing heard. 50 mg Benedryl liquid given PO at 2:24 pm. PHN on scene at 2:32 pm, 9-1-1 activated, Pt c/o continued neck pain 6/10, feeling hot, worsening of swollen tongue, throat tightness and swelling, now chest tightness, EMT reports no wheezes or stridor with auscultation of lungs and larynx. EMS on scene at 2:35 pm, assumed care. Pt transported to hospital at 2: 50 pm.
38 2021-02-03 ringing in ears experienced sudden onset of tinnitis mostly in my right ear, but both ears were affected. It sounde... Read more
experienced sudden onset of tinnitis mostly in my right ear, but both ears were affected. It sounded like I was hearing a lot of echoing/tinny sound in my ears every time someone was talking; This is a spontaneous report from a contactable pharmacist (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 at 5:00PM at single dose in left arm for COVID-19 immunisation at the age of 38-year-old. Lot number was EL3249. Medical history and concomitant medications were unknown. The patient was not pregnant at the time of vaccination. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 at 1:00PM at single dose in left arm for COVID-19 immunisation (lot number was EL1284) at the age of 38-year-old. About 26 hours after 2nd dose of vaccine on 22Jan2021 at 7:00PM, the patient experienced sudden onset of tinnitis mostly in right ear, but both ears were affected. It sounded like the patient was hearing a lot of echoing/ tinny sound in ears every time someone was talking. It only lasted a few hours and hearing returned to normal, but the patient had never experienced anything like that before, and it was so close to the vaccine administration, that she had to wonder if there was a correlation. The patient was not treated for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered from the event. Information on the lot/batch number has been requested.
38 2021-02-04 dry mouth Report of numbness of left arm, body aches, chills, nausea, HA, dry mouth, throat irritation . Trea... Read more
Report of numbness of left arm, body aches, chills, nausea, HA, dry mouth, throat irritation . Treatment: one dose of Ibuprofen Outcome: No improvement of symptoms, does not interfere with ADLs.
38 2021-02-04 dry throat face started itching; throat was getting dry; face was starting too itch and be red; hives after sec... Read more
face started itching; throat was getting dry; face was starting too itch and be red; hives after second dose of vaccine; This is a spontaneous report from a contactable Other HCP reported for herself. This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL1283, Expiry Date: 30Apr2021), via an unspecified route of administration on 18Jan2021 06:45 at single dose injected into left arm for COVID-19 immunisation. Medical history included asthma from 2010. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT EJ1685, EXP 31Mar2021.) on 18Jan2021 at 04:00PM, injected into her right arm for COVID-19 immunisation, uses salbutamol (ALBUTEROL, NDC: 6699301968, LOT: VE7L, EXP: Nov2021) inhaler as needed for asthma and took inhaled steroids, but nothing recent. The patient got the second dose of the vaccine at 06:45AM, and the hives began on the 21Jan2021, she noticed them about 06:20AM and she had to be at work at 07:00AM. She said she treated that with diphenhydramine hydrochloride (BENADRYL, 25mg LOT: P120108. EXP May2022, UPC: 193968051518) because her face started itching and her throat was getting dry, so she took BENADRYL 25mg this morning about 06:40AM. She says she took one dose of this by mouth, because it seems to make her sleepy and she had to work. She says she got to work and started working, and her face was starting too itch and be red, and her throat was super dry, this was at 07:20AM, so she took prednisone (NDC: 20603-5338-31, LOT 8675217, EXP Dec2020) 60mg by mouth. She says this was expired, but she still took it, it is in a dose pack that has a box that says distributed by (Company name). She says she took Prednisone 60mg, one time today by mouth. She says she has asthma so she keeps a prescription of Prednisone at home that her doctor writes so she can have it, she says with asthma she keeps Prednisone around. She says she also applied equate Hydrocortisone cream 1% (LOT: 0JT0306, EXP Aug2022) that she got over the counter to the hives topically. She says that the label for that says underneath anti-itch it says intensive healing that it is mixed with vitamins, chamomile and Vitamins A, C, and E. Equate Hydrocortisone cream 1% UPC: Unknown, the tube has a barcode with no number, it did have a box that she did throw away. She thought hives was medically significant, but it is not getting worse, it is worrisome, but she is improving with the medicine she used for treatment. The outcome of hives was recovering. The outcome of other events was unknown.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-02-04 oropharyngeal discomfort Approximately 7:00pm, I began to experience itching from head to toe. No rash noted. Had a little bi... Read more
Approximately 7:00pm, I began to experience itching from head to toe. No rash noted. Had a little bit of throat scratchiness, took 50mg of Benadryl and two Tylenol pills for my arm soreness and went to bed. When I woke up the next morning it was resolved.
38 2021-02-04 mouth tingling 12-20-20, started with tingling around my left lower lip at night time and the next morning I had ti... Read more
12-20-20, started with tingling around my left lower lip at night time and the next morning I had tingling going up to the left eye and cheek. No rash noted and concerned I was getting shingles. I saw a doctor and he did an eye exam to see if I had any shingles in my eye. My symptoms went away in few days.
38 2021-02-04 swelling around the eyes feeling some increasing shortness of breath; feeling some increasing shortness of breath; scratchy t... Read more
feeling some increasing shortness of breath; feeling some increasing shortness of breath; scratchy throat; some swelling in her bilateral periorbital area; have a mild headache; This is a spontaneous report from a contactable Pharmacist. A 38-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # EL3302) intramuscular at single dose at right arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included, chronic headaches and vertigo, depression, type 2 diabetes mellitus (DMT2), hypertension, vitamin d deficiency, sleep apnoea syndrome (OSA), chronic pain, psoriatic arthropathy, allergies: ACE inhibtors, gabapentin, lisinopril, Lyrica, milk products, nuts. Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: amlodipine (manufacturer unknown) 2.5mg, apremilast (manufacturer unknown), bupropion (manufacturer unknown) 150mg bid, calcipotriene (manufacturer unknown) topical, carvedilol (manufacturer unknown) 12.5mg bid, ergocalciferol (VIT D, manufacturer unknown) 1000 units, duloxetine (manufacturer unknown) 20mg bid, dicyclomine (manufacturer unknown) 20mg qid, losartan (manufacturer unknown) 50mg qday. The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # EL1284) intramuscular at single dose at left arm on 23Dec2020 12:30 PM for Covid-19 immunisation, administered at hospital. Patient denied any allergic reaction to the initial dose of Covid vaccine. No other vaccine has been received in 4 weeks. On 14Jan2021 12:00 PM after vaccination, she has being monitored for the mandatory 15-30 minute period, when she started feeling some increasing shortness of breath, scratchy throat, some swelling in her bilateral periorbital area. She was then taken to the ED for further evaluation. Patient denied any allergic reaction to the initial Covid vaccine 3 weeks before. She denied any abdominal pain, diarrhea, nausea, vomiting, chest pain, shortness of breath. She had a mild headache. In ED, patient received treatment with diphenhydramine 25mg IV, epinephrine 0.3mg IM, famotidine 20mg IV and dexamethasone 10mg IV, and LR 1,000mL bolus @ 1228, ketorolac 15mg @1312, ondansetron 4mg @1312. Patient monitored and discharged at 1530. Post vaccination, the patient has been tested with nasal swab for COVID-19 and resulted negative on 15Jan2021. Therapeutic measures were taken as a result of events. The outcome of recovered in Jan2021.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association
38 2021-02-04 swollen tongue Patient had the initial Pfizer COVID vaccine on December 18th. She started to having arthralgias, m... Read more
Patient had the initial Pfizer COVID vaccine on December 18th. She started to having arthralgias, myalgias, fever, fatigue and weakness starting on December 20th. The patient continuously had arthralgias, myalgias and weakness for the next few weeks. Patient follow up with physical therapist once a week to work on muscle weakness. The patient continuously had arthralgias and myalgias until January 10th. Primary care provider on January 7th orders CBC, autoimmune and thyroid panel since patient was having ongoing myalgias and arthralgias. Patient postpone 2nd dose because side effects from 1st vaccine were ongoing. Patient got 2nd dose vaccine on January 12th at 4:30pm. On January 13th at 11am the patient initially had nausea and arthralgias. Patient took Zofran 4mg ODT about 11:15am. 30mins later the patient tongue swelled. No lips swelling and no SOB. Patient immediately took liquid Benadryl 50mg to 75mg PO. Patient immediately drove to ED. Patient was observed until 2pm for progressive signs and symptoms of allergic reaction. Patient was discharge and advised to take Benadryl 25mg to 50mg every 4 to 6 hrs prn allergic reaction, Patient took famotidine 20mg at 4pm along with 25mg of Benadryl PO. Tongue swelling began to decrease. Patient also had fever, myalgia and arthralgias at 4:30pm. Took Tylenol 1,000mg and symptoms subsided (fever, myalgia and arthralgias). 1st Vaccine lot#EH9899 on left arm. 2nd Vaccine Lot#EL01T2 on left arm.
38 2021-02-04 tunnel vision tunnel vision; Muscle fatigue; joint pain; This is a spontaneous report from a contactable other hea... Read more
tunnel vision; Muscle fatigue; joint pain; This is a spontaneous report from a contactable other healthcare professional (HCP) communicated to a Pfizer colleague. A 38-years-old female patient (not pregnant) received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on right arm on 04Jan2021 at single dose for covid-19 immunisation. Medical history was None. The patient's concomitant medications were not reported. On 04Jan2021 the patient experienced tunnel vision, muscle fatigue, joint pain. No treatment was received for the events. The outcome of the events was not resolved. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of tunnel vision cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-02-06 dry mouth flu-like symptoms. Maximum fever of 102.2, body aches, shivering/cold chills, nausea, fatigue. Una... Read more
flu-like symptoms. Maximum fever of 102.2, body aches, shivering/cold chills, nausea, fatigue. Unable to stay awake for more than thirty minutes on first day. Loss of appetite. Dry mouth. Inability to preform basic tasks. Anhedonia. Severe to moderate symptoms lasting twenty-four hours, mild symptoms persisting.
38 2021-02-07 dry mouth RASH ON CHEST, UNDER CHIN AREA; SHORTNESS OF BREATH; INCREASED HR 109 ETC... DRY MOUTH; ITCHING ARMS... Read more
RASH ON CHEST, UNDER CHIN AREA; SHORTNESS OF BREATH; INCREASED HR 109 ETC... DRY MOUTH; ITCHING ARMS, LEGS CHEST, AND FACE. TOOK BENYDRYL AND ALBUTEROL INHALOR.
38 2021-02-07 dry mouth Feverish, chills, headaches, nausea, dry mouth, and sleepiness the day after the Vaccine was taken. ... Read more
Feverish, chills, headaches, nausea, dry mouth, and sleepiness the day after the Vaccine was taken. Started out slowly late morning around 9am and got worse by the afternoon. Took Motrin to relieve symptoms and slept. The next day felt better but in the evening on 2/5/21 felt itchy starting from arms and neck. Then after about 10 min of itchiness in that area and started itchiness down to my stomach and legs. I took allergy medication prescribed by my physician: Cetirizine HCL 10mg tablet (1 tablet). No issues after that. Had some issue with the itchiness from the first dose around the 3rd-5th day after the first vaccine was given. Didn't take any allergy medications and had a tiny bit of dark circular spots on limps and torso but wasn't severe. Thought that was from something I ate, or clothes detergent, etc. so shrugged it off.
38 2021-02-07 mouth numbness Numbness of my tongue and lips; This is a spontaneous report from a contactable nurse (patient). A 3... Read more
Numbness of my tongue and lips; This is a spontaneous report from a contactable nurse (patient). A 38-year-old non-pregnant female patient started to receive bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL8982; expiration date: unknown), via an unspecified route of administration left arm on 21Jan2021 17:00 at a single dose for covid-19 immunization. Medical history included migraine. The patient was not diagnosed with COVID prior vaccination. The patient has no known allergies. Concomitant medication included allopurinol (ELAVIL), paracetamol (TYLENOL), vitamin c [ascorbic acid] (VITAMIN C) zinc and prenatal vitamins. The patient has not had other vaccine in four weeks. The patient received her vaccine in a hospital. On 22Jan2021 01:00 AM, the patient experienced numbness of her tongue and lips. No treatment was received for the adverse events. The patient has not been COVID tested post vaccination. The outcome of the event was not recovered.
38 2021-02-07 lip pain I got the shot on a Saturday afternoon. Overnight Monday, I got an enormous and painful cold sore o... Read more
I got the shot on a Saturday afternoon. Overnight Monday, I got an enormous and painful cold sore on my lip, which extended an inch onto my face.
38 2021-02-09 ear pain With the second dose my symptoms started late evening on 01/13/2021. I started feeling bad, but fini... Read more
With the second dose my symptoms started late evening on 01/13/2021. I started feeling bad, but finished my shift. Felt drained, headache to start. By next morning (01/14) I had fever (101.5F) and the whose body aches, nausea, diarrhea, horrible horrible headache, like a migraine, severe congestion, runny nose and some days later I started having an earache on my right ear. I would like to mention I also had a vaginal discharge with an unpleasant odor that started with the first dose and had not resolved by the time I received the second dose and this time the odor is much stronger, it is awful, I already made an appt with my GYN. The odor got much stronger about a week after the second dose. I kept self medicating at home with Tylenol, Ibuprofen, but the fever would return as soon as the dose was weaning off. The 101.5F fever lasted for about 9 days. I also experienced shortness of breath from 01/14 until the 22nd and I never had to use my rescue inhaler before. I had to use it and had to even call for a second one. I am very athletic and active and never need it even after my runs and workout activities. I consulted with my PCP on the 19th and again she gave me a covid test. Negative. She diagnosed me with inner ear infection (right ear). Prescribed me Levaquin and in 2 days I was much better. On the 22nd I finally started seeing the symptoms subside and started feeling better. Also, I wanted to tell that I had a gas pain episode that almost sent me to the ER. My chest, my left shoulder hurt really really bad. I called a friend who is a physician and he told me to take some gasex first and if that did not work to go to the ER. Fortunately it worked. But the pain was excruciating.
38 2021-02-09 mouth tingling 10:26h - pt reports 'can't swallow', lips tingling, feels nervous/anxious while in parked car in pos... Read more
10:26h - pt reports 'can't swallow', lips tingling, feels nervous/anxious while in parked car in post-vaccination area, BP 138/72, pulse 91, O2 sat 88%, pt observed to be tachypnic but A&Ox3, responding appropriately 10:32h - BP 128/88, pulse 92, O2 sat 98%, MD arrived for further assessment, no meds given/no further interventions, close observation/monitoring only 10:38h - paramedics arrived, pt released to their care, AMA observed to be signed by pt and her partner/driver
38 2021-02-09 thirst really bad vertigo that I never had experienced before; Mild neck pain; tiredness; mild dizziness/fe... Read more
really bad vertigo that I never had experienced before; Mild neck pain; tiredness; mild dizziness/feel like passing out; nausea; Increased thirst; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration in the right arm on 22Jan2021 11:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced mild dizziness and some nausea the afternoon of the shot (22Jan2021). Increased thirst started that evening (22Jan2021) and continued till now, regardless of how much she drink. Mild neck pain and tiredness started the next day (23Jan2021 09:30). Then on day 3 (24Jan2021), the patient woke up with really bad vertigo that she never had experienced before. If she move her head, the room spins and she get really nauseous and feel like passing out. She ended up taking motion sickness medication for these and sleeping rest of day. Outcome of the increased thirst was not recovered while of the remaining events was recovering. Information on the lot/batch number has been requested.
38 2021-02-10 visual impairment Thursday started extreme fatigue, headache, muscle aches. On Sunday started rash on chest, arms and ... Read more
Thursday started extreme fatigue, headache, muscle aches. On Sunday started rash on chest, arms and legs with itching in face and throat. Went to urgent care on Monday and received steroid cream for rash. Rash went away by Thursday, but came back on Saturday, then have had a light redness on and off since the following Sunday. Still had the fatigue, headache, muscles aches, but started the shortness of breath, chest pain with dry cough, nausea. Saw NP on Thursday and got prednisone for cough and shortness of breath. Felt better on Thursday but got worse over the weekend with increased shortness of breath, chest pain with cough and spotty vision. Saw NP on Monday and was sent to ER to rule out life threatening illnesses. Finished the prednisone on Monday.
38 2021-02-11 loss of smell, loss of taste stuffy and runny nose, headache loss of taste and smell body aches. Tested Positive for COVID-19
38 2021-02-11 vision blurred At around 1030 hours the patient felt: dizzy, lightheaded, nauseous, had blurry vision, tightness in... Read more
At around 1030 hours the patient felt: dizzy, lightheaded, nauseous, had blurry vision, tightness in her throat, and was hypotensive with a BP of 62/27 and HR of 45. At around 1035 hours the patient was given 0.3 mg of epinephrine and her BP was then 81/37 and a HR of 55. Medics arrived at 1040 hours and the patient was sent to a hospital.
38 2021-02-14 oral mucosal blistering, pain in jaw Severe body aches, fever as high as 102.4; jaw pain, blister on roof of mouth, headache, fatigue
38 2021-02-15 sensitivity to light Severe headaches, throbbing head pain, sensitivity to light
38 2021-02-16 lip swelling, mouth numbness The night of the side effects were normal, over all fatigue. The next day my top, left upper lip st... Read more
The night of the side effects were normal, over all fatigue. The next day my top, left upper lip started to go numb and swell, because of the timeline of the event and the lack of any other symptom I was not thinking allergic reaction, but took a benedryl just in case. I feel asleep and woke up a couple hour later and the top upper lip swelling had started to go down, but my bottom lip had swollen and looked like a sausage. At this point it was pretty late at night and figured the ER had bigger problems to deal with and this was either going to be better by morning or worse and would deal with it then. When I woke up the next day I had some submental pain, but the swelling in my lip had gone down considerable. At this point I noticed I had considerable pain in my collar bone, I felt the area, noticed a mass, went to the mirror and saw what looked like a golf ball under my skin at my collar bone. My lymph nodes were completely swollen. I went to urgent care who instructed me to follow up with my PCP if it didn't go down in a week, my PCP told me we would follow up with an ultrasound if it didn't go down in a month. At this point this is getting ridiculous. I understand that swollen lymph nodes are a side effect, but it should not be for a month. This is causing me discomfort and gets worse the more I move around and on top of that I have been getting numbness in my left arm and hand which is what side the swollen lymph node is on.
38 2021-02-17 swelling of eyelid Received 2nd dose of Pfizer vaccine on 1/8 around 12:40pm. Only had a sore arm yesterday. The next ... Read more
Received 2nd dose of Pfizer vaccine on 1/8 around 12:40pm. Only had a sore arm yesterday. The next morning, woke up with mild abd cramping that resolved over about 1 hour. Throughout the day, had 2 episodes of NB diarrhea. At night, she noticed diffuse body hives and b/l upper and lower eyelid swelling. +accompanying mild SOB with audible wheezing. Pt took benadryl, zyrtec, and pepcid just before arrival to ED and reports feeling better. SOB/wheezing has resolved. Hives are mostly resolved. Only has residual eyelid swelling, Ice applied to eyelid and sent home for observation along with epinephrine pen.
38 2021-02-18 mouth numbness Nausea "weird feeling on the my tong" numbness of the tong
38 2021-02-18 mouth tingling Sudden onset of lip and face tingling, redness and rash to chest, flushed face and increased heart r... Read more
Sudden onset of lip and face tingling, redness and rash to chest, flushed face and increased heart rate
38 2021-02-18 swollen tongue, drooling COVID VACCINE CLINIC Subjective Patient is a 38 y.o. female who was seen at COVID Vaccine Cli... Read more
COVID VACCINE CLINIC Subjective Patient is a 38 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 30 min waiting period after the injection, the patient began to experience throat tightness and wheezy. She denied sob, cp, facial swelling, tongue swelling. She reports of above symptoms about 20 minutes after receiving vaccine. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting . PMH: Previous Reactions: allergies including anaphylaxis to shellfish, peanut oil and sulfa drugs. Reaction of arm swelling to location of shot and wheezy when she got the flu shot 7 years ago. Asthma hx. She had taken Singulair, cetirizine and albuterol prior to coming. She did not take any benadryl prior to her injection as pt reports that her sister whom is a nurse told her not to take benadryl in case it masks a reaction. ALLERGY REVIEW OF SYSTEMS: Patient complains of frequent throat clearing (slightly upon arrival. with throat itching) and wheezing Patient denies chills, fever, malaise/fatigue, facial swelling, itching in ears, sore throat, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, rash, hives, eczema, cysts, itching of skin, vomiting, abdominal pain, diarrhea, muscle aches, joint pain, dizziness and headaches Objective Vitals Vitals: 02/19/21 0933 02/19/21 0944 02/19/21 0952 02/19/21 1002 BP: (!) 143/83 134/81 126/80 123/70 Pulse: SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is not ill-appearing, toxic-appearing or diaphoretic. Comments: No facial or lip swelling HENT: Mouth/Throat: Lips: Pink. Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Uvula midline. No pharyngeal swelling, oropharyngeal exudate, posterior oropharyngeal erythema or uvula swelling. Eyes: General: Lids are normal. Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Neck: Trachea: Trachea and phonation normal. Cardiovascular: Rate and Rhythm: Regular rhythm. Tachycardia present. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Comments: Slightly tachycardia (103) Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds and air entry. No stridor, decreased air movement or transmitted upper airway sounds. No decreased breath sounds, wheezing, rhonchi or rales. Comments: Speaking full sentences. Musculoskeletal: Cervical back: Full passive range of motion without pain. Skin: General: Skin is warm. Findings: No rash. Comments: Injection site w/o erythema or swelling. No adhesive reactions Neurological: General: No focal deficit present. Mental Status: She is alert. Psychiatric: Mood and Affect: Mood is anxious ( slightly). Thought Content: Thought content normal. Judgment: Judgment normal. Re-evaluation of lung sounds and throat was done periodically about every 5-10 minutes. No acute findings seen/heard. Assessment/Plan Treatment included: albuterol, antihistamines, water and solu-medrol IM and pepcid, albuterol (pt used her own). Follow up response to treatment: excellent. Scale of 0-10 based on symptoms of tightness was 7 at first. Upon discharge was 3-4/10. Patient discharge: Stable to go home and follow up with PCP and her allergist. Differential Diagnosis: Anaphylaxis/anxiety (dyspnea, stridor, drooling, tongue swelling) We discussed close monitoring at home and when/if she were to take her epi-pen and call 911 if symptoms were to worsen. She's to let her allergist know about her visit today. She may need to have other medications taken prior to her #2 dose of Pfizer according to her allergist recommendations. Pt appreciative and is ready to go home. Pt wheeled out to front door by security. Accompanied by husband.
38 2021-02-19 ear swelling Fever 101.6, chills, sweats, nausea, muscle aches and pain, exhaustion,swollen itchy red ears, hives... Read more
Fever 101.6, chills, sweats, nausea, muscle aches and pain, exhaustion,swollen itchy red ears, hives all over body
38 2021-02-21 mouth ulceration 2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness,... Read more
2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM
38 2021-02-22 eye pain, eye swelling Sore arm, swollen eye (lump under the skin and visible in the rim of the eye, fatigue, malaise, head... Read more
Sore arm, swollen eye (lump under the skin and visible in the rim of the eye, fatigue, malaise, headaches, chills, diarrhea. All recovered other than the sore eye.
38 2021-02-23 lip swelling Patient experienced lip swelling, facial redness & swelling with tingling. Patient transported to E... Read more
Patient experienced lip swelling, facial redness & swelling with tingling. Patient transported to ER for further treatment.
38 2021-02-24 mouth numbness, vision blurred Bell palsy develop Wednesday early morning some numbness in lip but condition worsen around 7pm at n... Read more
Bell palsy develop Wednesday early morning some numbness in lip but condition worsen around 7pm at night, face droop, blurred vision , and paralysis set in. Thursday seen dr and started prednisone 20mg tablet , 2 tablet once a day and valtrex 20mcg , 3 times daily . Currently a week on meds and symptoms hasn?t improved. Never been diagnosed with bell palsy or have any neuroconditions. Blurred vision and paralysis is still the same. Have some eyelid and mouth movement.
38 2021-02-24 mouth numbness COVID-19 Vaccine Pt received first dose of vaccine in December and states that she only had a sore ... Read more
COVID-19 Vaccine Pt received first dose of vaccine in December and states that she only had a sore arm. She received second dose 1/13/2021 at 0813 and had no side effects. Around 1500, she developed chest pain and wheezing. She used her albuterol inhaler (pt has asthma), which helped. That night, she developed a sore arm. She woke 1/14/2021 around 0100-0200 from pain and was unable to go to back to sleep. She had aching in her left arm, as well as shooting pains through her arm and into palm. She took APAP 1000 mg PO x 1 and doxylamine which helped, but she was still unable to go back to sleep d/t pain. The pain expanded into her chest (especially with deep breaths), and upper back. She developed headache, sore throat, sweats and chills, shooting pain in her ear, painful and swollen left axillary lymph node, and the right side of her tongue became numb (numbness subsided after 1-2 hours). 1/14/21 morning, pt has persistent left hand pain, as well as joint pain in her feet, hips, and knees. She took another 1000 mg of APAP, which helped her pain. by 1/14 evening, she took 1000 mg APAP again and was able to sleep, although pt still endorsed sweats/chills. 1/15: Pt reports her pain is better, less severe, though now she is very fatigued and feels like she has been "hit by a truck". Her left axillary lymph node is still painful and swollen, but less painful than before.
38 2021-02-25 lip dry, taste impairment, mouth discomfort Metallic taste, burning sensation on lips, excessive dryness and peeling
38 2021-02-25 lip swelling mild lower lip swelling
38 2021-02-26 ear swelling I received the shot at 2:50, at about 5pm I had a bad headache and I noticed my left ear was hot. By... Read more
I received the shot at 2:50, at about 5pm I had a bad headache and I noticed my left ear was hot. By 6pm I noticed my ear was extremely red and swollen.
38 2021-02-28 mouth numbness, mouth tingling She began feeling dizzy with some nausea, apprehension, and numbness/tingling in her tongue. Her vit... Read more
She began feeling dizzy with some nausea, apprehension, and numbness/tingling in her tongue. Her vital signs were monitored every 5 minutes for 20-25 minutes, and she was given 20 mL (50 mg) liquid Diphenhydramine. Her symptoms subsided, and she was ambulatory and stable without distress at dismissal from clinic.
38 2021-03-01 eye pain About 3 hours after receiving the vaccine I started to have a headache that would go from the base o... Read more
About 3 hours after receiving the vaccine I started to have a headache that would go from the base of head on the right side, up the right side of my head to the back of my right eye. This lasted for 5 days. I had tried tylenol, ibuprofen, and advil with no relief. On day 4 I woke up with and additional symptom of nausea. I went to Urgent care where they tested me for Covid which came back negative and suggested this was side effects from the vaccine. The nausea lasted until the 7th day post vaccine.
38 2021-03-01 mouth tingling, swollen tongue Patient c/o of tingling on roof of mouth, and slight throat and tongue swelling approximately 12 min... Read more
Patient c/o of tingling on roof of mouth, and slight throat and tongue swelling approximately 12 minutes after IM injection. Continued to monitor as patient stated symptoms were improving but then got worse so Benadryl was given at 12034. EMS was contacted concurrently. EMS transported to local ER at 12:30
38 2021-03-02 eye discomfort, mouth discomfort My right eye,lips and face had discomfort; My right eye,lips and face had discomfort; My right eye,l... Read more
My right eye,lips and face had discomfort; My right eye,lips and face had discomfort; My right eye,lips and face had discomfort; I felt malaise for the rest of that day; right sided discomfort; This is a spontaneous report from a contactable nurse (patient). This 38-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231) via an unspecified route of administration on 21Jan2021 at 14:00 (at the age of 38-years-old) as a single dose in the right arm for COVID-19 immunization. The patient did not have any medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccine, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient reported taking unspecified concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 21Jan2021 at 14:30 the patient experienced right sided discomfort. Her right eye, lips, and face had discomfort; not pain but a strange feeling. The patient also felt malaise for the rest of that day (21Jan2021) and the following day. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcome of right sided discomfort, right eye, lips, and face discomfort, and malaise was recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
38 2021-03-03 smell distorsion, taste impairment The day after the injection I had a metallic taste and smell (almost like blood) that I've never exp... Read more
The day after the injection I had a metallic taste and smell (almost like blood) that I've never experienced before. It was very strong. I also have had increased acne in the days since the vaccine - which my husband also experienced.
38 2021-03-06 dry mouth, lip swelling, tongue disorder Patient presented for her first dose of Pfizer covid-19 vaccination today. She had Covid in the fall... Read more
Patient presented for her first dose of Pfizer covid-19 vaccination today. She had Covid in the fall. She has had anaphylactic reaction to antibiotics in the past, was advised she should be evaluated for 30 minutes post vaccination today. She agreed, was seated in the front row of chairs, next to the EMS and RN Observer tables. This RN checked in frequently with patient throughout her 30 minute observation period, conversing throughout the wait time. She reported feeling anxious about the vaccine and potential for side effects. She had her husband drive her to her appointment today. Her earlobes and forehead were flushed red and dry, but her neck was without redness. She had even, regular respirations and was able to speak clearly without issue. RN reassured her that we were here, assessing for any changes and were available to help. After 15 minutes, patient stated her mouth felt dry. RN offered water, patient accepted. She was able to drink and swallow without trouble. Patient's coloring remained the same, but she reported feeling better. She was still able to converse without difficulty. At about 29 minutes, patient stated she was worried that something may happen after her 30 minutes was up, stated her tongue was starting to feeling thick. RN offered her additional observation with EMS, alerted them to the situation. Patient checked out with RN station and this RN walked her into the hallway for EMS evaluation. EMS helped patient out of her sweatshirt and mask. EMS noted lip swelling and increased redness in her face, neck, chest, earlobes. EMS obtained vitals and administered 50 mg benadryl IM in her right deltoid. Patient's husband came in from the parking lot. Patient declined solumedrol injection due to her diabetes. EMS advised patient she needed additional evaluation and she was transported to hospital via ambulance. Patient's husband followed in his car. VAERS report filed.
38 2021-03-07 blindness transient Patient experienced three episodes of syncope between 1000-1100 on Sunday, 2/28 after receiving the ... Read more
Patient experienced three episodes of syncope between 1000-1100 on Sunday, 2/28 after receiving the vaccine on Saturday, 2/27 at approximately 1810. Loss of responsiveness ranged from approximately three to twenty seconds. Two of the three episodes were witnessed. Episode one occurred when patient attempted to sit up after waking. Episodes two and three occurred while attempting to change position from sitting to standing. Episodes were preceded by flushing, diaphoresis, graying/blackening vision, and tremulousness. Patient had not experienced syncope prior to these events. Patient recovered at home with increased fluids and rest on Sunday, 2/28 and outpatient infusion of normal saline at a naturopathic clinic on Monday, 3/1. Patient experience no further episodes of syncope as of 3/8 but did have multiple episodes of near-syncope in the week following vaccination. Syncope started at approximately 10 am on Sunday after having received the vaccine on Saturday at approximately 6:10 pm.
38 2021-03-07 mouth tingling At approximately 4:10 PM, patient reported "tingly lips" to lead RN. Lead RN assessed patient. Pati... Read more
At approximately 4:10 PM, patient reported "tingly lips" to lead RN. Lead RN assessed patient. Patient denied difficulty breathing, throat irritation, and itchiness. Lead RN noted unlabored breathing and noted no pallor and no cyanosis of the lips. EMT assessed patient vitals. Blood pressure 125/82 mmHg and pulse 90 beats per minute. Patient reported no other symptoms. Patient monitored for 15 minutes. Tingling resolved within 10 minutes. Patient stated she felt fine. Patient advised to seek emergency care if symptoms return and progress. Patient left facility at approximately 4:30 PM with steady gait and unlabored breathing.
38 2021-03-07 swelling of eyelid Day of injection: Foggy head, injection site pain, chills, fever, muscle aches, sensitive to touch (... Read more
Day of injection: Foggy head, injection site pain, chills, fever, muscle aches, sensitive to touch (lightly touching my skin felt like needles and washing my hair hurt my scalp). Day 2: Felt hungover, nausea, splitting headache, fever, muscle aches, sensitive to touch, lethargic Day 3: Sneezing (~60 + times), pain from lymph node in left armpit, dizziness, lump in throat, fever, lethargic Day 4: Sneezing, swollen and red eyelids, dizzy, lethargic
38 2021-03-08 eye irritation Patient complained at 5 pm of dizziness/burning of the throat, eyes and entire body fatigue 13 minut... Read more
Patient complained at 5 pm of dizziness/burning of the throat, eyes and entire body fatigue 13 minutes after receiving the vaccine. Benadryl 25 mg by mouth given per protocols at 5:01 pm. patient transferred to the urgent care for further observation at 5:06 pm. Patient stable upon transferring from Covid vaccine clinic
38 2021-03-09 mouth tingling Immediately felt dizzy/woozy. Within 1 minute felt extremely hot and a bright red, splotchy rash app... Read more
Immediately felt dizzy/woozy. Within 1 minute felt extremely hot and a bright red, splotchy rash appeared all over my chest, neck, face, back. Jaw and tongue felt tingly, but not unsure if that meant swollen. Medic checked heart rate and BP which were elevated. HR was in 120's and BP was 140's/80's for a prolonged period of time. Doctor gave Benadryl which seemed to help. Doctor and Medic watched me for an hour. Rash mostly went away within 5 hours, however once I came home, I noticed it had also been on my legs. The rash never produced hives, but the Doctor onsite confirmed this was an immediate allergic reaction, and said to see my regular doctor and an allergist. Since the shot some flushed look has come back in spots each day for a short period of time (maybe 10 mins or so). Still taking Claritin.
38 2021-03-09 light flashes or floaters in the eye On Tuesday 3/9/21 around 11:45 AM immunizing tech administered the 1st dose of the Pfizer Covid-19 v... Read more
On Tuesday 3/9/21 around 11:45 AM immunizing tech administered the 1st dose of the Pfizer Covid-19 vaccine to patient. During the 15 minutes recommended for patients to wait in the waiting room after being given the vaccine, she informed the pharmacy staff that she did not feel well. Immunizing technician & pharmacist accompanied patient to the rest room and brought female technician inside the restroom with her. Patient stated she felt dizzy and was seeing stars. Patient kept apologizing about the whole situation. Technician offered to get her a bottle of water. She got the water bottle, informed management to store expense it while the pharmacist was on stand by with the patient. Technician and pharmacist asked if they can come back into the bathroom and patient told team members she will be out in a minute. After 5 or so minutes passed, patient came out of the restroom and apologized about the whole situation again. Patient informed pharmacist and technician that she defecated, tried to vomit but was not able to. Pharmacist told patient to wait in the waiting area of the pharmacy as long as she needed. After 5 or so minutes, patient said she felt fine and was ready to go home. Pharmacist asked if she was okay to drive. Patient informed pharmacist that she no longer felt dizzy as before and that she was going to contact her husband to pick her up but she felt fine to drive. Pharmacist told patient he will document this event and asked patient if she had any questions or concerns to contact the pharmacy. Pharmacist called back and felt better after eating lunch. Patient stated this hasn't happened to her before after any vaccination.
38 2021-03-09 thirst Severe chills, headache weakness, fatigue nausea severe thirst
38 2021-03-10 mouth tingling I had extreme dizziness, facial numbness, tongue tingling and was observed during the observation pe... Read more
I had extreme dizziness, facial numbness, tongue tingling and was observed during the observation period. Later that day I had nausea and fatigue that lasted for 12 hours.
38 2021-03-11 mouth numbness Pt received her vaccination around 11.58am and advised to stay for observation by RPh for 30minutes ... Read more
Pt received her vaccination around 11.58am and advised to stay for observation by RPh for 30minutes due to history of her throat closing up due to Aleve allergy years ago. Patient started reporting fast heartbeat about 10minutes after and we concluded that it might be because she was anxious and continued to observe pt. However, she started feeling foggy, tongue felt numb, and throat started to hurt as well. Pt was not able to clarify whether her throat was closing up. Due RPh professional judgement, she gave pt EpiPen 0.3mg injection on Left thigh considering pt history and called paramedics. Pt was seen by paramedics at the pharmacy and brought to ER/urgent care for treatment. Called patient several hours after, and she is currently fine at home.
38 2021-03-11 mouth tingling Chest pain, shortness of breath, itching, tingling in the mouth
38 2021-03-14 taste impairment Metallic taste in mouth that was transient. Developed and resolved during the 15 minute observation ... Read more
Metallic taste in mouth that was transient. Developed and resolved during the 15 minute observation period following vaccination.
38 2021-03-14 swollen tongue Immediately after vaccination had sensation of tongue swelling. No rash, no nausea/vomiting, no lig... Read more
Immediately after vaccination had sensation of tongue swelling. No rash, no nausea/vomiting, no lightheadedness. On exam patient was in no acute distress, well appearing, clear voice, no rash, clear oropharynx with no appreciable tongue swelling. Patient reports symptoms resolved spontaneously with no intervention while talking with providers. Patient drinking her own water/gatorade. Patient taking her own benadryl and husband in car who is a physician driving patient home. Discussed indications for calling 911 if needed. Given health provider line number. VSS: HR 90s, O2sat 97-98%, BP 129/66.
38 2021-03-18 ear pain Pfizer-BioNTech COVID-19 Vaccine Symptom started a few minutes after the vaccine, around 1:50pm, ... Read more
Pfizer-BioNTech COVID-19 Vaccine Symptom started a few minutes after the vaccine, around 1:50pm, and lasted until approximately 5:30pm. Symptoms: ear or head pressure. Felt like when driving from a height altitude to a lower one, and the fast change of heights causes the ears to get plugged with a feeling of great pressure.
38 2021-03-18 mouth tingling 3 pm c/o chills all over, stated "have anxiety all the time and this may be it." Agreed to being mo... Read more
3 pm c/o chills all over, stated "have anxiety all the time and this may be it." Agreed to being monitored by this RN and EMs. BP 141/95, HR 130. Tingling on lips. 3:10 pm Stated feeling much better. Allowed to leave observation area.
38 2021-03-18 vision blurred Immediately after vaccination #1 at 0945 pt. noted "fuzziness, then cold at injection site and throu... Read more
Immediately after vaccination #1 at 0945 pt. noted "fuzziness, then cold at injection site and throughout body." BP at 1010 was 140/100. By 1040 BP was 130/88 and "coldness" had resolved and "fuzziness" had improved. States also that her distance vision had been blurred at 0945 but had resolved by 1040. She left the POD ambulatory at 1050. Follow up call 3/19 finds no sequelae; pt. reports complete recovery. Is scheduled for #2 dose 3/31. Advised to report event and BP spike to her doctor and be advised about receiving 2nd dose.
38 2021-03-20 mouth lesion, mouth itchiness itchy throat, mouth, and around skin mouth, mild rash around mouth, inflammation of throat, sent to ... Read more
itchy throat, mouth, and around skin mouth, mild rash around mouth, inflammation of throat, sent to the ER, tachycardia, O2 95% on room air at first reading in ER waiting area. Was given IV push of Pepcid, Benadryl, solo-medrol, and atarax. Monitored in ER for a few hours.
38 2021-03-20 ringing in ears Tinnitus beginning in the late evening of the 2nd day following the injection
38 2021-03-22 swollen lips, lip swelling Upper lip swelling day after my second vaccine that is painful and significant. Swelling has not res... Read more
Upper lip swelling day after my second vaccine that is painful and significant. Swelling has not resolved with Benadryl that was suggested and remains significantly swollen and inflamed. Right side of upper lip started swelling first and then it slowly spread to the left side of the upper lip. Bottom lip not impacted. No other signs of respiratory distress or rash. I did spike a fever exceeding 103.6 after the vaccine and had aches/chills/nausea/headache but these were all expected. The lip swelling has been the outlier.
38 2021-03-22 hearing loss, ringing in ears About an hour or so later after receiving the 1st dose of Pfizer COVID-19 vaccine, I started having ... Read more
About an hour or so later after receiving the 1st dose of Pfizer COVID-19 vaccine, I started having muffled hearing or clogged ears like when you come down from a plane ride and your ears have not ?popped yet? or when you drive up a mountain or high altitude, and then immediately, ringing in the ears(both ears) clogged and ringing. Took an ibuprofen and it got better by the time I went to sleep but it is still a bit muffled or clogged, especially on my left ear. Titinnus?
38 2021-03-22 lip swelling, mouth tingling During 1st dose (2/27/2021 lot En 6202) patient developed swollen lips starting on 2/28/21. However,... Read more
During 1st dose (2/27/2021 lot En 6202) patient developed swollen lips starting on 2/28/21. However, patient assumed it was due to a change in laudry detergent that masks were watched in the previous day). During the 2nd does, Sunday, March 21, 2021 the patient stared to have tingling in lips 3/21/21 the by 6:00pm on 3/22/21 the lips were swollen. Patient took 50mg of diphenhydramine at 8pm. On 3/23/21 the swelling was worse on the lips, cheeks swollen, and ears itching. Another 50mg of diphenhydramine at 6am. The swelling did not change and patient went to ER at 7:30am. Patient was given 10mg decamethasome, 50mg diphenhydramine, and 20 mg famotide at 7:54am. Doctor noted minor swelling in the throught. At 1030am patient was released. Meds helped swelling some but not all the way. ER doctor believes it us angioedema.
38 2021-03-22 mouth tingling Patient reported her tongue felt like it was getting larger- no visible enlargement on exam. Patien... Read more
Patient reported her tongue felt like it was getting larger- no visible enlargement on exam. Patient was given 50mg of Diphenheramine by mouth with partial symptom resolution in 40 minutes and complete resolution by 80 minutes. Patient went home with significant other released to self care.
38 2021-03-23 deafness Felt lightheaded and warm. Started to lose hearing. BP dropped 90/50's, HR 40's. Recovered in 20 ... Read more
Felt lightheaded and warm. Started to lose hearing. BP dropped 90/50's, HR 40's. Recovered in 20 mins
38 2021-03-23 mouth tingling, tongue itchiness, swollen tongue (note: I had no reaction to the first dose) 13 hours after receiving my second dose I had been in b... Read more
(note: I had no reaction to the first dose) 13 hours after receiving my second dose I had been in bed for a couple of hours unable to get comfortable because I felt weird. That?s when my ankles and feet began to itch. I checked for mosquito bites, none were there but I noticed that my ankles and feet were swollen. I applied a lotion recommended eczema thinking my skin might be dry. Over the next hour the itching got worse and spread up my calves. That?s when I noticed that my tongue felt weird and kinda poofy. I?m used to occasional dry mouth due to my meds, but this was nothing like that. It freaked me out so I got up took Allegra hoping that on top of the Zyrtec I?d taken hours before would help. Since I was restless and desperately needed sleep I took 1/2 of a 15mg trazadone tablet. That did the trip. No itching and I was able to sleep. Now I?ve been in bed all day with flu-like symptoms, I?m miserable and I?ve missed work. Unless I awake tomorrow morning feeling magically better I?ll miss work again. The itching and swollen tongue really freaked me out, hence my report today.
38 2021-03-23 vision blurred, thirst Fatigue, blurred vision, increased thirst, increased urination after receiving second vaccination (... Read more
Fatigue, blurred vision, increased thirst, increased urination after receiving second vaccination (Started 2/10/21)
38 2021-03-24 taste impairment Day of injection: pain at injection site, extreme fatigue. Next day: Extreme fatigue, fever (100-101... Read more
Day of injection: pain at injection site, extreme fatigue. Next day: Extreme fatigue, fever (100-101.7), whole body ache but especially on the left side, metallic taste in mouth.
38 2021-03-25 extreme sound sensitivity Fatigue/extreme tiredness, sound sensitivity, pain at the injection site, brain fog (lack of mental ... Read more
Fatigue/extreme tiredness, sound sensitivity, pain at the injection site, brain fog (lack of mental acuity), dull persistent headache even after tylenol, aspirin, and ibruprofen,
38 2021-03-25 ringing in ears, extreme sound sensitivity Starting the night of the vaccine, a lot of constant buzzing in ears, periodic feeling of fullness i... Read more
Starting the night of the vaccine, a lot of constant buzzing in ears, periodic feeling of fullness in ears & sensitivity to loud sounds in ears. Went to sleep. Awakened dry heaving & had vomited some bile. Couldn?t stand or walk due to extreme dizziness & moderate nausea continued. Called PCP and was seen at 1pm on march 26th. My son had to help me walk all day so far. The doctor office checked my vitals & my ears. Vitals good. No infection. Diagnosed with vertigo & prescribed Meclizine. 4p was 1st dose. Seems to be helping some. Nausea has subsided. Buzzing is present, but quieter. Still too dizzy to walk without assistance
38 2021-03-26 dry mouth Fever, chills, shaking, full body pain, sweating, dry mouth, headache, dizziness
38 2021-03-27 taste disorder About 10 minutes after receiving the shot I got a slight taste and a sensation in the back of my nos... Read more
About 10 minutes after receiving the shot I got a slight taste and a sensation in the back of my nose. Within an hour it moved a little lower to listen station in the back of my throat. Almost a sensation like before you would throw up but not the same. Soon after developed nausea which lasted and intensified until bed around 10pm. A sore arm that eve, but not major. Woke up feeling pretty well with just a sore arm. Developed chills and mild fever which persisted rest of that day and following day. Fever mostly around 100-100.4. Got up t0 100.6. Ear thermometer registered 101 at one point but shortly after jumped down so it seemed unreliable. On day 4 fever subsided and felt normal. On day 5, sensation in back of throat and nausea returned. No fever.
38 2021-03-28 taste impairment, dry mouth Metallic taste in mouth and dry mouth every day since 2nd vaccine.
38 2021-03-29 ear pain, ear infection, toothache, mouth tingling Day 1 - Tingling, itchy mouth Day 2 - nerve tooth pain started Day 3-6 - excruciating nerve pain Day... Read more
Day 1 - Tingling, itchy mouth Day 2 - nerve tooth pain started Day 3-6 - excruciating nerve pain Day 7-14 - rash, diagnosed Shingles Day - 14-19 ear pain - ear infection Day 28 - nerve sensations still present
38 2021-03-29 mouth tingling, mouth numbness c/o numbness/ tingling around mouth and SOB chest pain x 2 minutes after vaccine. No swelling or fac... Read more
c/o numbness/ tingling around mouth and SOB chest pain x 2 minutes after vaccine. No swelling or facial flushing noted.rash not on patient not typical of patient . Patient felt numbness and tingling resolved but not chest pain/ SOB. 121/85,83,98% o2 RA . Patient transported to ED for unresolved chest pain and rash. Transported to hospital
38 2021-03-29 swollen tongue, taste impairment, mouth numbness, lip swelling About an hour after the shot, I started to feel the left side of my face (specifically the jaw area)... Read more
About an hour after the shot, I started to feel the left side of my face (specifically the jaw area) getting numb and tingly. With the progression of the day, my entire left side of my face was numb and I was feeling pain and burning sensations in my left year. Movement in that side of my face was okay. By the evening, my lips had also gone numb and were swollen. The left side of my tongue also swell, which resulted in me biting it a couple of times. At night, the numbness and swelling got worse, but my breathing was always okay. My lips and tongue went back to normal within 24 hours, however the numbness in my face and the pain the my ear have persisted and I still feel some of these sensations and pain after almost 7 days since receiving the vaccine. Also, at least one time per day, but sometimes more often, I get a metallic taste in my mouth when I am not eating or drinking anything at that particular time.
38 2021-03-29 ringing in ears Persistent constant ringing in both ears at same consistent pitch. Onset within 2 hours of vaccine i... Read more
Persistent constant ringing in both ears at same consistent pitch. Onset within 2 hours of vaccine injection and continuing now as of 2 weeks later
38 2021-03-29 vision blurred Brain fog, severe headache, blurred vision, constant urination, fatigue , leg cramps, trouble breath... Read more
Brain fog, severe headache, blurred vision, constant urination, fatigue , leg cramps, trouble breathing and irregular heart beat. that have lasted since day of vaccine. Still suffering from some symptoms
38 2021-03-30 ringing in ears, extreme sound sensitivity Thirty minutes after receiving the shot my ears started ringing very loudly and all of the noises ar... Read more
Thirty minutes after receiving the shot my ears started ringing very loudly and all of the noises around me became amplified. 24 hours post vaccine the tinnitus and sound amplification has not improved. I am not disoriented or dizzy.
38 2021-03-30 visual impairment My arm felt as if I could feel the vaccine moving down it, then began to tingle. My vision went wei... Read more
My arm felt as if I could feel the vaccine moving down it, then began to tingle. My vision went weird for a few minutes and I felt light headed and as if my whole body was vibrating/buzzing a bit. It's hard to describe, but I knew something wasn't right. I spoke with a nurse on site who suspected I had a vasovagal reaction to the vaccine. I had to wait 40 minutes before I felt okay enough to leave the site. I continued to feel off for the rest of the night, along with extreme fatigue and soreness in my arm, neck and back. The day after the vaccine I still had extreme fatigue, muscle soreness, was nauseous, with hot flashes and chills throughout the day. Currently on day 2 past the vaccine and still have fatigue and muscle soreness. The other symptoms seem to have improved some. I have not been able to sleep much that last 2 nights either.
38 2021-03-31 eye swelling, lip swelling, mouth numbness Allergic reaction within 1-2 minutes. My eyelid and upper lip started to swell and my face and lips... Read more
Allergic reaction within 1-2 minutes. My eyelid and upper lip started to swell and my face and lips became numb and tingly. I have had hives in the past and this is how it always starts. They were accompanied by the sensation of heat in my face as well. I drove myself to an urgent care and my BP was extremely elevated. I believe the highest was 190/114. The staff at Urgent Care waited to medicate me, perhaps due to my elevated BP. My forearms became very flushed, almost a purple hue, but no hives developed. My throat started to swell and they called an ambulance to take me to the hospital. In the minutes before the ambulance arrived, I was given epinephrine and Benadryl via injection in my right arm. I wish they had given me that more quickly. I started to feel better very quickly. By the time I was hooked up to monitors at the hospital, right across the parking lot, my BP had gone down to 123/71. There was never any sign of swelling of the tongue, but my throat felt tight the remainder of the evening and I had difficulty swallowing. I am still itchy in my legs today and my cheeks and eyebrows still feel numb. I am currently taking Prednisone for the next few days and was given an Epi Pen prescription. I was given the vaccine at 12, arrived at Urgent Care about 1:00 and was transported to the hospital around 2:30. I was discharged around 5:00.
38 2021-03-31 lip swelling, mouth tingling, swollen tongue Lip swelling/tingling, tongue swelling
38 2021-04-01 deafness, ringing in ears Severe bilateral tinnitus; Hearing loss; This is a spontaneous report from a contactable nurse repor... Read more
Severe bilateral tinnitus; Hearing loss; This is a spontaneous report from a contactable nurse reporting for self. A 38-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 19Jan2021 (at the age of 38-years old) (Batch/Lot Number: EL1293) as a single dose for COVID-19 immunization. The patient had not received any other vaccines in the 4 weeks prior. Medical history included postural orthostatic tachycardia syndrome (POTS) from an unknown date. The patient had not experienced COVID prior to vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT 162b2 on 29Dec2020 at 12:00 PM, in left arm for COVID-19 immunization; and previously received CECLOR and experienced allergy. The patient developed severe bilateral tinnitus and hearing loss on 04Feb2021 at 2:00am, 2 weeks after vaccination with 2nd dose. The event resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit, and Disability or permanent damage. As treatment for the events, the nurse reported "multiple visits to doctors and medications hearing." The outcome of the events severe bilateral tinnitus and hearing loss were not recovered. The patient wasnot COVID-tested post vaccination.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of tinnitus and hearing loss due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
38 2021-04-01 dry mouth 3:45 3/30 Dizziness 7:30 3/30 Pain at Injection Site Extreme Stomach Pains Dizziness 8:30 3/30 Al... Read more
3:45 3/30 Dizziness 7:30 3/30 Pain at Injection Site Extreme Stomach Pains Dizziness 8:30 3/30 All of the above plus Chills and Headache 9:30 3/30 All of the above Dizziness getting worse 3/31 Dry Mouth Injection Site Pain Chills Severe Dizziness Weakness especially in legs Stomach Pains Tiredness Headache (Called Doctor and was prescribed Meclizine) 4/1 Arm Pain went away Diarrhea started Extreme dizziness and weakness-Meclizine not helping Low grade fever of 100.3 Chills Achy Headache Tired 4/2 Bad headache on left side of head Extreme Dizziness and Weakness Fever of 101.4 Chills Tired
38 2021-04-01 eye pain Moderate side effects: at hour 12, onset of nausea in muscles/body/head/eyes, pain, insomnia, chills... Read more
Moderate side effects: at hour 12, onset of nausea in muscles/body/head/eyes, pain, insomnia, chills/shaking. Acute side effects passed after 36 hours, but deep fatigue and brain fog persisted. After 4 days, symptoms of RA flare set in.
38 2021-04-01 lockjaw, ear discomfort Tingling/ numbness in left side of face; felt like tingling was spreading across face under eye for ... Read more
Tingling/ numbness in left side of face; felt like tingling was spreading across face under eye for 15-20 minutes; felt acute pressure in left ear; jaw popped also on that side
38 2021-04-04 eye discharge Twisted mouth, one nostril was drooping left nostril, left eye running & can?t blink eye.
38 2021-04-04 eye pain On April 3rd at 6:00 am I awoke with difficulty breathing and intense abdominal pain. Took my eye m... Read more
On April 3rd at 6:00 am I awoke with difficulty breathing and intense abdominal pain. Took my eye medicine (Cyproheptadine 4mg) in the morning, difficulty breathing subsided, but abdominal pain remained. Became lethargic, noticed a fever around 9:00 am. Fever was 100 degrees Fahrenheit. Chills, muscle pains all over body, nausea, inability to eat, acid reflux, temporary loss of feeling in right toes. Around noon my fever was 102, and my walking heart rate was 146 bpm (according to fitbit sense watch). I took two Tylenol tablets (recommended dose 2 for adults according to bottle). Went to urgent care. Fever subsided, and bpm returned to mostly normal. Blood draw revealed thrombocytopenia. Platelets were at 72 (units of measurement), normal range is 150-450 (units of measurement). I was told recommended hospitalization occurs at 50 (units of measurement). April 4th. Painful abdomen, lack of appetite, nausea, headache. Took 1 Tylenol. Lethargic. Slept most of the day. Pain behind my eyes. Headache located in front behind both eyes. Dry throat. Constantly drinking water and Gatorade, Thirsty. April 5th. Headache remains. Pain behind eyes remain. Lack of appetite. Planning for second blood draw on April 7th to check Platelets.
38 2021-04-04 pupils dilated Headache around 15 minutes after shot, dizziness, nausea, racing heart, dilated pupils at 29 minute... Read more
Headache around 15 minutes after shot, dizziness, nausea, racing heart, dilated pupils at 29 minutes after shot.
38 2021-04-04 ringing in ears tinnitus constant ringing in left ear. Occasional ringing in right ear. Ongoing since onset.
38 2021-04-05 ear discomfort Around 1:35pm I noticed my nose starting to itch. I didn?t think anything of it and continued to dri... Read more
Around 1:35pm I noticed my nose starting to itch. I didn?t think anything of it and continued to drive. Around 1:38 I started feeling very hot and numb in my face, ears, and toes. I felt that my heart was beating very rapidly and I felt a sinking feeling in my stomach, and felt I might pass out. I pulled over and contacted 911 for fear of my reaction progressing. Around 1:45pm I started to feel better. By the time the ambulance arrived, I felt a little fuzzy but better. They checked breathing and vitals, all of which were normal. By the end of the day my symptoms had self resolved.
38 2021-04-05 lacrimation increased, eye swelling I noticed swelling upper right eye lid initially then little whitish bumps (2 small) on the lower e... Read more
I noticed swelling upper right eye lid initially then little whitish bumps (2 small) on the lower eye lid.My doctor thought it was a growth gave me a antibiotic. I exp some drainage from eye and bumps lasted 3 weeks.
38 2021-04-06 lip dry, lip swelling, lip pain, lip itchiness, chapped lips, swollen lips Woke up day after vaccination with very dry lips. Over a 3 day period they became severely chapped, ... Read more
Woke up day after vaccination with very dry lips. Over a 3 day period they became severely chapped, dry, cracking, peeling, itchy, soreness. Medicated lip bam caused very uncomfortable stinging and itching. I used a non medicated, natural lip lip balm constantly up until about 3/10/2021, when they started to feel a bit better. Received 2nd dose of Pfizer/BioNTech vaccine, same location, same appt time, Lot #EN6207 on 3/13/2021. The next day, 3/14/2021, my lips started to rapidly become very chapped, dry and irritated again. This time I had swelling and broken skin. I continued using the same lip balm consistently until 4/6/2021, when they started to feel better again. Today, 4/7/2021, my lips are almost back to normal. I have never experienced an issue like this in my life, that I can recall. Just a major discomfort and inconvenience, and I haven?t heard of this anywhere.
38 2021-04-06 swelling of eyelid Had a stye that was almost healed at time of vaccine. After getting the vaccine my eyelid swelled an... Read more
Had a stye that was almost healed at time of vaccine. After getting the vaccine my eyelid swelled and presented with intense itching with numerous small painful bumps. At 1.5 weeks post vaccine has not healed and has gotten worse.
38 2021-04-06 ringing in ears Tinnitus in the left ear
38 2021-04-06 vision blurred, eye pain, eye swelling, lacrimation increased, bloodshot eyes 2 hours after: right eye watering, nose running. 8 hours after: right eye red, swollen, very difficu... Read more
2 hours after: right eye watering, nose running. 8 hours after: right eye red, swollen, very difficult to open, blurred vision, burning sensation, sensation of a foreign object. Went to ER. Could not read any letters on the vision chart out of right eye. Given numbing eye drops and antibacterial eye drops. 12 hours after vaccination: right eye still swollen and painful, but slightly less inflamed.
38 2021-04-07 loss of smell, loss of taste Patient tested positive for COVID-19 after completing the full Pfizer vaccine series, 86 days after ... Read more
Patient tested positive for COVID-19 after completing the full Pfizer vaccine series, 86 days after 2nd dose. Patient received 2nd dose of COVID vaccine on 01/05/21 . Tested positive on 04/01/21. NOT hospitalized. "Symptoms reported: Chills, fatigue, loss of taste, loss of smell; Symptom onset date: 3/31/2021" No known exposure outside of work. I have not traveled or eaten at restaurants or gone anywhere unmasked. Cared for a COVID + patient on 3/25, 3/26, 3/30 - wore my PAPR as fit tested to. "First COVID positive test; Did care for COVID + patient on 3/25/2021"
38 2021-04-07 taste impairment, canker sore Missed period. I have been consistently at 28-30 day cycles for years and I had cramping day 28-30 o... Read more
Missed period. I have been consistently at 28-30 day cycles for years and I had cramping day 28-30 of my cycle and swollen breasts and bloating, but no period. My cycle was supposed to start 3/31 and I still haven?t had it as of 4/8 today. I have taken 4 pregnancy tests that are negative. This is very unusual for me. My only other side effects were sore arm, metallic taste and canker sores for three days after my first dose and the same only about 12-18 hours after my second. I want to know why my period disappeared, should women have smaller doses? How many ovulating women took part in these studies?
38 2021-04-07 painful gums, mouth pain, mouth swelling, toothache My mouth has developed swollen, red, tender gums and also some areas of roof of mouth. Behind front ... Read more
My mouth has developed swollen, red, tender gums and also some areas of roof of mouth. Behind front upper teeth is the worst. Also on inside of right premolars area is very tender and sore. A slight bit of tenderness and swelling on inside of right cheek where premolars are also sore. Inside upper lip in top most center area is also red and swollen and extends down front to teeth. I took some ibuprofen but it did nothing. I just now took two Benadryl and it might be feeling a slight bit of improvement. First symptoms started yesterday evening around 5pm. This morning symptoms became more pronounced. And now at 8:30pm it feels much higher level of discomfort. My left lymph node under mandible is a bit swollen too. And around 3pm I felt like I had a slight fever but didn?t take temp. I Otherwise feel fine and have no other medical issues occurring. When I was 10 I was diagnosed as having PCN allergy. I recall something like this happening about five days after I was prescribed. Something like this also happened after taking Sulfa antibiotic but it was at back of throat about 4 days after first administration. That was in 2015.
38 2021-04-07 sensitivity to light Patient received vaccination 5:25pm for second dose of Pfizer vaccine. Patient stated that after the... Read more
Patient received vaccination 5:25pm for second dose of Pfizer vaccine. Patient stated that after the 1st dose she had a fibromyalgia breakout with tingling in the hands, headache. Patient stated that about 15 minutes she had the injection she started to have some the same symptoms, slight tingling in the hands, light sensitivity. Had patient wait until 5:55pm. Patient stated that symptoms weren't really worsening or improving, denied dizziness and shortness of breath/itchiness. Patient stated that she would like to go home and she how she feels because it was starting to feel like a fibromyalgia breakout, advised patient to contact PCP if symptoms worsen or go to emergency room if she experiences severe dizziness or shortness of breath. Will follow-up with patient tomorrow to check on them.
38 2021-04-07 swollen tongue Patient has nausea and vomiting after receiving her Pfizer vaccine first dose. She has mild dizzines... Read more
Patient has nausea and vomiting after receiving her Pfizer vaccine first dose. She has mild dizziness. She felt like her face is red, warm, and swelling of the tongue noted. Benadryl IM given. Transferred to the ED
38 2021-04-07 ringing in ears Tinnitus (high-pitched ringing in the ears) starting after vaccination. Doctor's visual inspection ... Read more
Tinnitus (high-pitched ringing in the ears) starting after vaccination. Doctor's visual inspection of eardrum indicates everything looks normal. Wait and see if tinnitus gets better/worse/same. Recommended to contribute with second vaccination dose.
38 2021-04-07 vision blurred Pt began c/o blurred vision and sweaty palms. Pt states she did not eat breakfast. Fingerstick 110, ... Read more
Pt began c/o blurred vision and sweaty palms. Pt states she did not eat breakfast. Fingerstick 110, pt given apple juice and one hard candy. Pt was able to distinguish how many fingers was holding up. BP 125/80, HR 92. Pt AOx3. Pt has bilateral upper & lowe extremity strength 5/5. After 30 min of unresolved blurred vision, patient escorted to ER.
38 2021-04-08 eye pain, bloodshot eyes Left eye pain and entire sclera blood red. No discharge
38 2021-04-08 mouth numbness Right side of face tingly and numb around mouth and eye. General numbness in right arm and in finger... Read more
Right side of face tingly and numb around mouth and eye. General numbness in right arm and in fingers.
38 2021-04-08 lip swelling sudden onset intense itching, lips swelling, hoarseness
38 2021-04-08 oropharyngeal discomfort 8 minutes after shot in Left Deltoid, pt developed scratchy throat, dry cough, dry cough got worse a... Read more
8 minutes after shot in Left Deltoid, pt developed scratchy throat, dry cough, dry cough got worse after 2 minutes and pt reported throat felt funny, appeared pale and states throat felt really strange. Epi 0.3ml was given due to complaint of throat tightness, scratchy throat, and dry cough; classic signs of anaphylaxis. Pt also received 50 mg Benadryl IM. After Epi pt reported throat tightness improved. Pt was then transferred to ER for observation after EPI.
38 2021-04-08 mouth tingling, lip swelling Within the first 10 minutes I was nauseous, developed a headache and started feeling very warm. The... Read more
Within the first 10 minutes I was nauseous, developed a headache and started feeling very warm. They had put me in the 15 minute wait area, and I did not report my symptoms as I didn't immediately think it was cause for concern or necessarily a reaction related to the shot. After the 15 minute waiting period, I returned to my vehicle and started driving. At this point, I was hot enough that I took off my coat and turned the A/C to 67 degrees even though it was 35 degrees outside. About 10 minutes later (25 minutes after receiving the shot), my upper lip started tingling, and within another 5 minutes (30 minutes after the shot) I looked in the review mirror and noticed my face and upper lip were swollen. The vaccinated clinic was 45 minutes from my home and there is not much between the clinic site and my home, therefore, I kept driving. About 50 minutes after getting the shot, the face and lip swelling started to decrease . I was able to access Benadryl at this point in time by stopping at a pharmacy, which helped my allergic type symptoms from that point onward. I did continue to have a headache, fatigue, and chills for the remainder of that day.
38 2021-04-08 swollen tongue Swollen throat and tongue
38 2021-04-09 ringing in ears, vision blurred, visual field defect headache; blurred vision; couldn't stand without assistance; a band of numbness and tightness in my ... Read more
headache; blurred vision; couldn't stand without assistance; a band of numbness and tightness in my right arm that migrated down my arm from the site of the vaccination all the way to my wrist; a band of numbness and tightness in my right arm that migrated down my arm from the site of the vaccination all the way to my wrist; The site of injection also became very sore; a band of vice-like grip appeared around the lower part of my head, near my jaw, and it migrated up my head until it settled around my temples and eyes; faintness; strong vasovagal response; narrowing field of vision; rushing sound in ears; dizziness/severe dizziness; nausea; This is a spontaneous report from a contactable consumer (patient) reported for self. A 38-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 at 16:30 (Lot number: EP7533) on the right arm at single dose for COVID-19 immunization. Medical history included chronic lyme disease, hypothyroidism, allergies to cephalosporin antibiotics. Concomitant medications included levothyroxine, metronidazole, sertraline, clonazepam (KLONOPIN); that all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnosis with covid-19 and patient had not been tested for covid-19 since the vaccination. Patient experienced a strong vasovagal response within 30 seconds of receiving the dose with narrowing field of vision, rushing sound in ears, faintness, dizziness, nausea; all of these symptoms improved after lying on the floor for 15 minutes. 2 hours later, a band of vice-like grip appeared around the lower part of patient head, near patient jaw, and it migrated up patient head until it settled around patient temples and eyes. The patient developed a headache, blurred vision and severe dizziness such that he couldn't stand without assistance. Patient also felt a band of numbness and tightness in his right arm that migrated down his arm from the site of the vaccination all the way to his wrist. The site of injection also became very sore. There was no treatment received for the adverse events. The outcome of events was recovering.
38 2021-04-09 ringing in ears Immediately following receiving the vaccine, my heart rate became very elevated, my face, nose and h... Read more
Immediately following receiving the vaccine, my heart rate became very elevated, my face, nose and head began burning and my hands were cold and tingling. My blood pressure went extremely high. I immediately felt my body reacting to the injection My entire body did not feel right. I was taken to the emergency room by ambulance. Since having the vaccine I have had constant tinnitus that will not go away, a buzzing/nerve sensation through my entire body, dizziness and notice my heart rate feeling elevated. I am on day 10 after the vaccine and still have these symptoms.
38 2021-04-09 eye floaters, vision blurred Blurred vision/focus issues/can't focus visually/couldn't see right; floaters; left arm and leg went... Read more
Blurred vision/focus issues/can't focus visually/couldn't see right; floaters; left arm and leg went numb; Both arms and legs tingly; felt disoriented; cold chills; Legs and arm felt heavy; my eyes are now having esophoria convergence Excess or vergance dysfunction; my eyes are now having esophoria convergence Excess or vergance dysfunction; my eyes are now having esophoria convergence Excess or vergance dysfunction; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 18Mar2021 11:45 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included allergies to Penicillin and no other medical history. The patient had no COVID prior vaccination. The patient was no pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ALLERTEC); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D). There was no vaccine in four weeks. The patient stated that right after she drove off, Blurred vision/floaters, left arm and leg went numb. Both arms and legs tingly, felt disoriented, cold chills, had to pull the car over because she couldn't see right. Legs and arm felt heavy. Blurred vision & focus issues had continued and the eye doctor said her eyes were now having esophoria convergence Excess or vergance dysfunction. She still can't focus visually since she drove off from the vaccine. She had to go to the doctor today & they were going to schedule a neurologist appointment to make sure she didn't have a mini stroke. It had been extremely scary since she received it. All events occurred on 18Mar2021 12:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received for the events and she needed glasses with a prism and neurologist appointment. The patient had no COVID tested post vaccination. The outcome of the events was not recovered.
38 2021-04-10 eye strain Vertigo Started in the morning all day Felt dizzy ,off balance , eyes were heavy Took Tylenol and... Read more
Vertigo Started in the morning all day Felt dizzy ,off balance , eyes were heavy Took Tylenol and gravel for motion sickness did not help lasted all day. Later in day I took a THC medicinal gummy helped me feel a lot better. Symptoms went away by night. I was exhausted from the vertigo. Scared me because it affected my eyes.
38 2021-04-10 deafness, ringing in ears Acute onset of tinnitus and hearing loss.
38 2021-04-11 mouth tingling She reports she initially felt weird immediately after receipt and noted her heart was racing. She w... Read more
She reports she initially felt weird immediately after receipt and noted her heart was racing. She was waiting her 15 minutes, she felt hot, when she noted her face was flushed. She briefly felt dizzy but it passed. She asked staff if the flushing was normal and they got the medics. They noted flushing to her face, neck and chest. (She noted flushing to her legs when she got home). She denies pruritis or urticaria. Her BP and HR were elevated. She felt a little confused: they were asking her if she felt she needed eval, but she felt she had trouble answering. She noted tingling to her left jaw, and tongue. Providers did exam which was normal and gave her benadryl and monitored her for an hour. She felt better and was released. The flushing continued intermittently for brief periods (minutes) to sites such as her neck and face. She continued benadryl 50 mgs at bedtime. She routinely takes Claritin this time of year and had that morning. Symptoms resolved and have not returned. She denies pruritis, oral/face/throat/tongue swelling, globus sensation, red watery eyes, rhinorrhea, dyspnea, wheezing, CP, cough, n/v/d.
38 2021-04-12 eye pain, pain in jaw 10-16 hours after (4/7): insomnia, confusion due to all-over body pain (myalgias, arthralgias), occa... Read more
10-16 hours after (4/7): insomnia, confusion due to all-over body pain (myalgias, arthralgias), occasional stabbing abdominal pain and lung/back pain 16-30 hours after (4/7): increasing fever to 3.5 F over normal temperature with continued all-over severe pain including eye pain about 20 hours after (4/7): diarrhea (same thing happened with shot #1 at same timing) 16-50 hours after (4/7-4/8): loss of appetite 24-40 hours after (4/7-4/8): increasing headache with increasing nausea, borderline migraine 24-30 hours after (4/7): rapid (resting) heart rate days 3-5 (4/9-4/11): fatigue, light-headedness days 2-3: pain around injection site radiating up through neck and jaw day 3 onwards (continuing): axillary lymph nodes around injection site sore/tender The outcome was that I couldn't work for 2 days and couldn't sleep the first night due to all-over pain.
38 2021-04-12 bleeding gums First two days had a sore arm. Starting exactly one week from the vaccine administration, I started ... Read more
First two days had a sore arm. Starting exactly one week from the vaccine administration, I started my period two weeks early. This has never happened. I also had bleeding gums. The bleeding gums have stopped. As of today, I?m still bleeding vaginally. It has not been heavy bleeding. Light to moderate only.
38 2021-04-12 fluid in middle ear Unexplained fluid in the ears causing vertigo. Still ongoing
38 2021-04-12 ringing in ears 3/13/21 Received first Pfizer COVID vaccine to right arm. The next day on 3/14/21 she developed ring... Read more
3/13/21 Received first Pfizer COVID vaccine to right arm. The next day on 3/14/21 she developed ringing in the ears.
38 2021-04-12 ringing in ears Ringing in errors. Sounds like I'm in a tunnel. Pulsing.
38 2021-04-13 lip swelling Anaphylaxis and swelling of the lips - administered benadryl and patient felt better
38 2021-04-13 thirst Patient reports feeling warm, nauseous, thirsty and clammy before lowering herself to floor. Episod... Read more
Patient reports feeling warm, nauseous, thirsty and clammy before lowering herself to floor. Episode occurred 15 mins after vaccination. Symptoms improved after lying down.
38 2021-04-13 ringing in ears, extreme sound sensitivity Four days after receiving the vaccine I woke up early in the morning to a loud ringing in my left ea... Read more
Four days after receiving the vaccine I woke up early in the morning to a loud ringing in my left ear that made it hard to hear and made loud sounds more uncomfortable than usual. The ringing remained all day but did become a little less noticeable toward evening. By the next morning (Wednesday) the ringing was very quiet and did not affect my hearing very much. However, the ringing came back to being very loud and made my hearing muffled on Thursday. Again, it improved on Friday and returned Saturday. It has followed this pattern ever since. It never completely goes away but does get better and worse.
38 2021-04-13 ringing in ears Tinnitus developed after about 10 days in both ears. Otherwise, healthy 38 year old with no prior ti... Read more
Tinnitus developed after about 10 days in both ears. Otherwise, healthy 38 year old with no prior tinnitus issues.
38 2021-04-13 vision blurred At 3:11pm, 5 minutes post injection, patient began to feel anxious with dizziness and blurred vision... Read more
At 3:11pm, 5 minutes post injection, patient began to feel anxious with dizziness and blurred vision. Moved to lie down on floor. Patient states she has not eaten today. Brought by litter to observation area at 3:45pm. Patient laid down, vitals taken. Given water. Patient notes mild nausea. 4:08pm, patient reports normal vision. Denies nausea. Given crackers to eat. Moved to edge of bed, vitals rechecked. Feeling well. Patient released by wheelchair.
38 2021-04-14 loss of taste, loss of smell, ringing in ears, smell distorsion PHANTOM SMELL OF CIGARETTE SMOKE (THERE IS NO ACTUAL SMOKE ANYWHERE NEARBY), RINGING IN THE YEAR, LE... Read more
PHANTOM SMELL OF CIGARETTE SMOKE (THERE IS NO ACTUAL SMOKE ANYWHERE NEARBY), RINGING IN THE YEAR, LEFT GRATER THAN RIGHT. It is important to note that I already had Covid-19, twice. The second time was in January of 2021 (just 3 -4 months ago). At that time I lost my sense of smell and taste, and had ringing in my ear. When smell and taste began to come back I had the phantom smell of cigarettes and that lasted until just a few weeks ago (I would say 4 -6 weeks ago it finally went away). After the first dose of the Pfizer Vaccine (LOT NUMBER EN6203) taken at the same location as this second one, I experienced flu symptoms 24 hours later (vaccine date was 3/22/2021). I had a fever and body aches and a very strong headache but both went away by the second day. It was only after the second dose that I started to experience the phantom smell of cigarettes and the ringing in my ears once again. I am not sure if it was triggered by the vaccine or if I was doomed and would have had it anyway, after all I experienced it for a while after Covid. I also tested positive for antibodies in February. So I probably still had the antibodies present in my body when I got both doses of the vaccine.
38 2021-04-14 taste impairment Four minutes after vaccine administration, severe burning chest pain, lightheadedness, dizziness, sc... Read more
Four minutes after vaccine administration, severe burning chest pain, lightheadedness, dizziness, scratchy throat, metallic taste in mouth was experienced. The next day, a pruritic rash appeared on my right forearm and bilateral thighs. Two days after vaccine numbness to right leg that lasted about 24 hours.
38 2021-04-14 eye irritation BURNING EYES APROXIMATELY 15 MINUTES AFTER VACCINATION - RESOLVED @07:55 ACCORDING TO PATIENT -NO BR... Read more
BURNING EYES APROXIMATELY 15 MINUTES AFTER VACCINATION - RESOLVED @07:55 ACCORDING TO PATIENT -NO BREATHING PROBLEM, NO RASH
38 2021-04-14 mouth numbness, loss of taste Patient presented to my office for a routine visit (as her family doctor) the very next day after sh... Read more
Patient presented to my office for a routine visit (as her family doctor) the very next day after she started noticing symptoms. First it started with some numbness of her tongue on the left and accompanying decrease in taste. The next morning (day of my appointment with her) she woke up with left side facial drooping involving the entire left face. I diagnosed her with Bell's Palsy today and discussed the case with a neurologist at the academic center nearby and started treatment of prednisone for 7 days. Also instructed other conservative measures such as eye wetting drops and eye patch.
38 2021-04-14 mouth numbness, mouth tingling Throat tightening. Rapid heart rate of 120 bpm while resting. Tingling/numb mouth.
38 2021-04-14 lip swelling Lower lip swollen, pale, weak, sweating. B/P 116/90, BP 151/91 IV 0-9 Sodium chloride given, 50ml of... Read more
Lower lip swollen, pale, weak, sweating. B/P 116/90, BP 151/91 IV 0-9 Sodium chloride given, 50ml of Benadryl 3mg Epinephrine
38 2021-04-14 vision blurred Within 5 minutes of receiving shot I felt woozy, had mild face and throat swelling, blurry vision, a... Read more
Within 5 minutes of receiving shot I felt woozy, had mild face and throat swelling, blurry vision, and hives on face. All symptoms except woozy feeling went away within 3 hours. Did not feel fully well until 24 hours later.
38 2021-04-15 taste impairment Metallic taste, vaccinated arm feels numb/cold throughout entire arm "instant". BP 123/62; HR 97; RR... Read more
Metallic taste, vaccinated arm feels numb/cold throughout entire arm "instant". BP 123/62; HR 97; RR 18, SpO2 100%, Temp 99.1F
38 2021-04-15 eye swelling, swelling around the eyes Exactly two weeks after the 2nd covid shot, to the hour, my eyes became puffy and swollen. Eyelids, ... Read more
Exactly two weeks after the 2nd covid shot, to the hour, my eyes became puffy and swollen. Eyelids, under eye, between eyes - all was swollen. Also, three small (about 2") rashes: under chin and inside both wrists. Stayed swollen 48 hours before selling medical care. Could not think of anything I had a reaction to. No new laundry soap, pillow, food, drink, facial product. Only thing done that I'd never done or used or had before was I spent 2 hours on the deck of an indoor swimming pool. 48 hours after onset, I visited virtual care Doctor. Prescribed Zyrtec (once daily) and opthalmic erythromycin. Started at bedtime, woke up to eyes more swollen than before. Visited walk in clinic and told to stop erythromycin, start famotidine (20 mg twice daily x5 days) and prednisone (50 mg qd x3 days) and continue Zyrtec. Cleared within 2.5 days.
38 2021-04-15 lip swelling Tingling and numbness in face at 25 minutes post shot. Told to take Benadryl. Throat began to swell... Read more
Tingling and numbness in face at 25 minutes post shot. Told to take Benadryl. Throat began to swell at 35 minutes post shot. Took Benadryl went to bed. Next morning took more Benadryl at 7am. At 11am face started to tingle. Drove to mom's. She said she could see my bottom lip swelling. Face began to twist and droop. Went to ED. Had MRI.
38 2021-04-15 mouth tingling, lip swelling, swollen tongue Anaphylaxis, tongue tingling and swelling, lip tingling and swelling, facial tingling and swelling, ... Read more
Anaphylaxis, tongue tingling and swelling, lip tingling and swelling, facial tingling and swelling, difficulty breathing, nausea
38 2021-04-16 eye itchiness my daughter and I had itchy eyes; This is a spontaneous report from a contactable physician. This p... Read more
my daughter and I had itchy eyes; This is a spontaneous report from a contactable physician. This physician reported for two patients. This is 2 of 2 report. A 38-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 26Jan2021 09:00 (Batch/Lot Number: EL9263) as SINGLE DOSE for covid-19 immunization. The patient is small, not overweight, a little on the skinny side. Patient medical history was none. Family medical history was none. There were no concomitant medications. The patient did not receive any prior vaccinations within 4 weeks. AEs follow prior vaccinations was none. Additional vaccines administered on same date of pfizer suspect was none. History of all previous immunizations was not provided. It was reported that caller, her daughter, and her husband, all received the first dose of the Pfizer COVID vaccine on 26Jan2021. Caller and her daughter experienced very itchy eyes on 27Jan2021-28Jan2021. It then subsided. Asked if this is an allergic reaction and would it interfere with getting the second dose. If it is an allergic reaction, would there be a worse allergic reaction to the second dose, which is scheduled for 26Feb2021. Has the same question for her daughter too. The reporter was concerned if it plays an relevance to the second COVID shot. The patient frequently takes care of the caller, who is 79, and caller's husband, who is 84. On that basis was offered the COVID Vaccine. The AEs did not require visit. Relevant tests was none. Investigation Assessment was none. The event was assessed as insignificant. Relatedness assessment of drug to event by unspecified company was unknown. Outcome of the event was recovered on 28Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116744 same reporter/drug/AE, different patient.
38 2021-04-16 ringing in ears Tinnitus starting 2 hours post-vaccination (possibly earlier but I was outside) and still ongoing. ... Read more
Tinnitus starting 2 hours post-vaccination (possibly earlier but I was outside) and still ongoing. Appears to be fluctuating in intensity but has been persistent.
38 2021-04-17 taste impairment Metallic taste in mouth within minutes of receiving shot. Arm pain and soreness. Slight headache.
38 2021-04-17 sensitivity to light Mild headache began within five minutes of receiving vaccine, which worsened until dissipating at ar... Read more
Mild headache began within five minutes of receiving vaccine, which worsened until dissipating at around 9 pm. At around 1 am spiked a fever; at 11 pm it was 97.5 (which is normal); it peaked at 7 am at 101.4. Chills until the morning of the 17th. Fever between 100.0 - 101.0 continued until the morning of the 18th. Body aches all day on the 17th and morning of the 18th. Severe headache with migraine-like symptoms all day on the 17th and into the morning of the 18th (throbbing, sensitivity to light and sound). Nausea all day on the 17th, which culminated in vomiting (once) around 9 pm on the 17th. Nausea dissipated after vomiting.
38 2021-04-18 dry mouth 1030 - Patient complained of itchiness, dry mouth, throat itching. Given water and Benadryl 25mg PO.... Read more
1030 - Patient complained of itchiness, dry mouth, throat itching. Given water and Benadryl 25mg PO. Patient reports having multiple allergies with similar reactions. Patient lying down. BP = 145/87, HR = 79, RR = 18, O2 Sat = 100% 1039 - Patient reports increasing itchiness. BP = 134/66, HR = 71, O2 Sat = 100% 1045 - Patient reports feeling the same. 1057 - Patient talking, reports feeling the same. BP = 130/75, HR = 80, RR = 18, O2 Sat = 100% Benadryl 25mg PO given. 1108 - Patient reports symptoms improving. 1119 - Symptoms resolved - patient reports no dizziness/sleepiness. BP = 122/80, HR = 74, RR = 17, O2 Sat = 100% 1121 - Patient ambulated with nurse out to reception to check out.
38 2021-04-18 eye pain Pain on my eyes and headache Really bothers me
38 2021-04-18 eye swelling, swelling around the eyes Hopefully like symptoms and soreness in the arm after the shot. Aftee waking the next morning I thre... Read more
Hopefully like symptoms and soreness in the arm after the shot. Aftee waking the next morning I threw up 3 times. Over the course of the next few days for headaches nausea stomach cramps and developed multiple rashes throughout my body including I swelling and puffiness around my eyes that still remains.
38 2021-04-18 extreme sound sensitivity, loss of taste burning pain in the distribution of the left facial nerve, loss of taste, hyperacusis left ear
38 2021-04-18 lip swelling, mouth tingling Patient brought in by rescue squad reportedly after allergic reaction to of Pfizer COVID vaccine 1st... Read more
Patient brought in by rescue squad reportedly after allergic reaction to of Pfizer COVID vaccine 1st dose. Rescue squad gave her a dose of Solu-Medrol IV and an IM shot of Benadryl 50 mg. Patient reports that she initially became very itchy she still remains very itchy she thought she had some tingling or may be slight swelling her lips and felt like she was having some problems breathing but admits she is very anxious because of her extensive allergy issues. Here she is clearly very pruritic and slightly flushed. But is breathing easily speaking in full complete sentences. She has no other acute complaints. Symptoms started within minutes after receiving immunization.
38 2021-04-18 pain in jaw Pt reports the following reactions that started 24 hrs after receiving the 1st dose: Heart racing; F... Read more
Pt reports the following reactions that started 24 hrs after receiving the 1st dose: Heart racing; Facial flushing; skin tenderness; bilateral jaw pain; soreness at the injection site
38 2021-04-18 ringing in ears, hearing loss Humming, ringing and muffled sounds in left ear
38 2021-04-18 vision blurred vision blurry, fainted, leg numbness, headaches
38 2021-04-19 lip swelling *Patient was being observed in the patient waiting area post injection given at 11:00am. Had to wait... Read more
*Patient was being observed in the patient waiting area post injection given at 11:00am. Had to wait 30 minutes due to prior reaction to MMR in December of 2020. At 20-25 minutes post injection patient started itching with arms and chest becoming red. Nurse and NP observing came over to patient and assessed. They administered Benadryl 25mg due to itching and redness. Advised patient to go home and also take Pepcid to help the Benadryl. Patient drove home immediately and by 12:00pm after looking in mirror lips and lower arms minimally swollen. Patient took another 25mg of Benadryl. No change, skin continues to break out and itch. Right lower forearm begins to swell more. Patient takes a third Benadryl 25mg along with a Prednisone 20mg PO. After the 75mf of Benadryl total and Prednisone 20mg the reaction gradually subsides, but does not go away 100%. It is manageable at this time. *Overnight the patient develops dizziness and headache. *By morning (07:00am on 04/16/2021) the patient is itching minimally, dizzy, has headache, nauseated, and now is experiencing vertigo with what feels like equilibrium imbalance. Patient stays home from work and rests all day. No fever, no SOB, and no other signs at this time. *Patient continues to show the above signs through Monday, April 19, 2021 with now on Tuesday April 20, 2021 additional signs of night sweats, muscle cramps, and soreness in her legs.
38 2021-04-20 vision blurred - injection site bleed, eventually bruised (still exists 7 days after) - radiating nerve pain in arm... Read more
- injection site bleed, eventually bruised (still exists 7 days after) - radiating nerve pain in arm at moment of injection, expected due to know needle reaction/intolerance - muscle spasms at injection site after about 15m that continued for approximately 2 days - swelling at injection site, immediate, still present - parasthesia in lower arm, presumed due to swelling, lessened with time but still present - sense of lethargy at 30m, profound enough to have me stay in the parking lot for an extra hour, randomly hits - blurred vision development at 2hrs that was constant from them until becoming intermittent at 4/20/2021 - HEADACHE at about 30m mark, constant and still present - body pain increased at about 1hr, noticeable beyond typical body pain, continuous - nausea, intermittent, first bout was at about 6hr, have had "attacks" each day - fatigue, at 6hr, impacting more activities each day, profound - lower extremity bruising in the calf muscle, bilateral, appears to be deep vein rupture (for the record, recently evaluated for DVT(clear) and current medications create anticoagulation effect) - general increase to most problematic neurological symptoms currently under review
38 2021-04-21 dry mouth Roughly 12-14hrs after shot I experienced a very painful headache , full body aches with muscle and ... Read more
Roughly 12-14hrs after shot I experienced a very painful headache , full body aches with muscle and pain all over (head to toe), fever was 101-102, chills, dry mouth and my throat was swollen (hurt to take ibuprofen). About 7-8hrs after symptoms began I had diarrhea and was nauseous. 24hrs after symptoms began, they were gone and I felt fine.
38 2021-04-21 dry throat 0850 - Patient reported mouth was dry and throat was tight - was given water. Patient laid down and... Read more
0850 - Patient reported mouth was dry and throat was tight - was given water. Patient laid down and fanned to cool off. HR = 98, RR = 16, O2 Sat = 98%. Face went from red to pink and patient stated she "responds similarly to new things" and this was a "typical reaction". She has a personal epi pen (not used at this time). 0912 - Patient feeling fine - back to normal. Patient left clinic.
38 2021-04-21 taste impairment nausea immediately after vaccine, continuing off on on for several hours before ceasing increased le... Read more
nausea immediately after vaccine, continuing off on on for several hours before ceasing increased level of exhaustion developing within 24 hours and lasting for 72 hours metallic taste in mouth immediately after vaccine, diminishing over 72 hours
38 2021-04-21 ear swelling Patient reported on form that they had a previous allergic reaction to a meningitis vaccine in the p... Read more
Patient reported on form that they had a previous allergic reaction to a meningitis vaccine in the past (10+ years ago). Immunizer informed patient to stay at pharmacy for the next 30 minutes following the vaccination to be able to monitor for allergic reaction. At around minutes 20-30, we checked in on patient who said she was experiencing shortness of breath. She began administering her inhaler that she had on hand (Ventolin/albuterol), it was not having any noticeable effect. Patient reported worsening shortness of breath and reported that she felt a swelling sensation and felt that her ears were swelling. She was visibly struggling with breathing. At this time we helped her back into the immunization area for privacy. Myself (pharmacist) and the other pharmacist on duty were talking her through breathing and trying to calm her down while helping her contact a family member in the area. We administered 1 dose of epinephrine 0.3 mg after about 10-15 minutes of her experiencing a visible serious allergic reaction. Right before administering the Epinephrine we instructed a technician on staff to call EMS. Within about 5 minutes of administering epi the patient began to be able to breathe better. We kept trying to keep her calm and within 10 minutes from administering EPI the EMS had arrived and they took her outside to allow her more fresh air to determine if she needed to go to the hospital.
38 2021-04-21 eyelid function disorder Elevated resting heart rate - 20-40bpm higher than normal. Was 90-105bpm at rest for 24 hrs starting... Read more
Elevated resting heart rate - 20-40bpm higher than normal. Was 90-105bpm at rest for 24 hrs starting around 10pm evening of vaccine. (Normal is high 60s for me.) Fever - 101.1 - noticed morning after vaccine, lasted 18 hrs Arm soreness - 2 days Splitting headache with drooping eyelids - started morning after vaccine and continued 24 hrs Fatigue/exhaustion - started 8 hrs after vaccine and lasted 1.5 days
38 2021-04-21 bloodshot eyes, vision blurred, eye itchiness Swollen arms and hands, Numbness pins and needles whole body over first two days, Swollen Numb Face ... Read more
Swollen arms and hands, Numbness pins and needles whole body over first two days, Swollen Numb Face off and on. First 2 days. Face felt like hives but never surfaced. Itchy Red Eyes, body aches, fever/chills, joint pain, nausea, Blurry vision twice the first 2 days lasted briefly. euphoria. Off work for 3 days felt back to normal after 6 days. Traveled Dec end of 2019. Returned with bad Cold out of work for a week +
38 2021-04-22 dry throat, lip swelling, oral mucosal blistering Pt had a sore and dry throat, with minor swollen lips for few minutes and blisters in her mouth
38 2021-04-22 taste impairment Received Pfizer vaccine on 2/5/21, 2/26/21 Tested positive for COVID-19 by PCR on 4/21/21 Symptoms o... Read more
Received Pfizer vaccine on 2/5/21, 2/26/21 Tested positive for COVID-19 by PCR on 4/21/21 Symptoms of cough, dysgeusia beginning 4/18/21.
38 2021-04-22 eye pain Headache, pain in eyes feel dizzy more than 10 days acetaminophen 500 Ibprophen 600
38 2021-04-22 eye discomfort Fatigue, febrile, malaise times one week following vaccine. Developed shingles in right eye, and for... Read more
Fatigue, febrile, malaise times one week following vaccine. Developed shingles in right eye, and forehead one week post vaccine.
38 2021-04-22 mouth discomfort, mouth tingling Complained of lips burning, flushing, tingling to lips. 50 mg Oral Benadryl given. Symptoms dissipa... Read more
Complained of lips burning, flushing, tingling to lips. 50 mg Oral Benadryl given. Symptoms dissipating Taken home by daughter
38 2021-04-23 ear pain, ringing in ears After almost a week of persistent symptoms from the vaccine, I went to a local health clinic. Thw he... Read more
After almost a week of persistent symptoms from the vaccine, I went to a local health clinic. Thw health care professional who treated me said the vaccine made my body believe that it had COVID. I was diagnosed with severe tinnitus from severely irritated eardrums, irritated throat and nose, ear pain, Estachian tube disfunction, and headaches. Recommended treatment was Afrin nasal spray, prescription-strength Sudafed, and Zyrtec. I have never had any prior ear problems in my life.
38 2021-04-23 lip dry, lip redness, lip swelling, taste disorder 1. Loss if salt taste only for about 2-3 weeks. 2. Pain on my salivary gland 3. Dryness on and in... Read more
1. Loss if salt taste only for about 2-3 weeks. 2. Pain on my salivary gland 3. Dryness on and inside my bottom lip with redness and slight swelling 4. Skin Rash
38 2021-04-23 visual impairment On Apr. 17, I had a sore arm at the injection site and a slight headache. On Apr. 20, I began to be ... Read more
On Apr. 17, I had a sore arm at the injection site and a slight headache. On Apr. 20, I began to be very tired and the headache became more intense. Apr. 20 I has a mild night sweat. By mid day on Apr. 21, I have severe back pain, body aches and extreme fatigue, in addition to a continuous headache impacting my vision. Apr. 21 I had an extreme night sweat, requiring me to change in the middle night and constant chill. These symptoms persisted through Apr. 22. I was not able to work on Apr. 21 and 22. The symptoms continued but were mild on Apr. 23rd. The back pain, chills, fatigue and headache continued Apr. 24.
38 2021-04-24 oropharyngeal discomfort Around 20-30 minutes after getting the shot my throat felt weird. Almost like there was a lump in th... Read more
Around 20-30 minutes after getting the shot my throat felt weird. Almost like there was a lump in the back. It went away after a few hours.
38 2021-04-25 smell distorsion Abnormally heavy and long menstruation resulting in iron-deficient anemia, lasting 2 weeks, with abn... Read more
Abnormally heavy and long menstruation resulting in iron-deficient anemia, lasting 2 weeks, with abnormally painful cramps. Episodes of fainting, nausea, diarrhea, and vomiting. Smell hallucinations, muscle soreness, brain fog.
38 2021-04-25 ringing in ears, deafness Dizziness, motion sickness, tinnitus, loss of hearing, increased susceptibility to abscesses
38 2021-04-27 swelling of eyelid, lip swelling 24 hours after the vaccination , I had swelling in my left hand. 48 hours later I had swelling in bo... Read more
24 hours after the vaccination , I had swelling in my left hand. 48 hours later I had swelling in both hands, followed by hives on both hands. I was put on a seven day Medrol dose pack. Once completed I experienced swelling of the face, lips, eyelids and tightness around my mouth.
38 2021-04-27 swollen tongue, tongue discomfort One to two days after the pfizer vaccine the taste buds on the tip of my tongue were swollen and unc... Read more
One to two days after the pfizer vaccine the taste buds on the tip of my tongue were swollen and uncomfortable for about 5 days.
38 2021-04-28 ringing in ears anxiety; night sweat; fatigue/extremely fatigued; nerve pain; body aches; had a slight ringing in my... Read more
anxiety; night sweat; fatigue/extremely fatigued; nerve pain; body aches; had a slight ringing in my ear; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in right arm on 25Mar2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included post viral syndrome (chronic fatigue), dry eye, known allergies included lactose intolerance and had adverse reactions to Botox. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications in two weeks included Vitamin B, D, Magnesium, zinc, copper, omega 3. No other vaccine was received in four weeks. On 25Mar2021 (pending clarification) by 2am the patient woke up with a horrible anxiety and night sweat. Evening two the patient had some fatigue, evening three I had a flare up of nerve pain and body aches, same issues night four. By night five the patient felt like her entire body was on fire with nerve pain. Day six on 30Mar2021 the patient was extremely fatigued and had a slight ringing in her ear that remained. The patient slowly regained her strength and functioning. The events resulted in "Doctor or other healthcare professional office/clinic visit, Disability or permanent damage". No treatment was received for events. The outcome of events was recovering. Information on the lot/ batch number has been requested.
38 2021-04-28 ringing in ears Throat swelling, chest pain, difficulty breathing, rapid heartbeat, high pitch ringing in ears, numb... Read more
Throat swelling, chest pain, difficulty breathing, rapid heartbeat, high pitch ringing in ears, numbness in face, upper body, arms and hands about 6 hours after shot was given. 103.5 fever for 18+ hours, severe nausea, severe headache, lethargic, muscle aches, body aches, chills & shaking.
38 2021-04-29 eye bleeding, bloodshot eyes Severe muscle aches, pain, swollen lymph nodes, extreme fatigue, blood shot left eye- 2 blood vessel... Read more
Severe muscle aches, pain, swollen lymph nodes, extreme fatigue, blood shot left eye- 2 blood vessels bled in eye
38 2021-04-29 mouth itchiness, tongue itchiness, swollen tongue About 10-15 minutes post-vaccination, she started to have itching in her mouth (her tongue, mainly).... Read more
About 10-15 minutes post-vaccination, she started to have itching in her mouth (her tongue, mainly). Also felt like tongue was swelling and throat was tight/swelling. Chest felt tight as well. She has asthma and said it felt like she had just breathed in the "worst allergen." She did not seek help from the EMT at the site and remained sitting in the observation area. She then developed a flat, mottled rash that started on her neck, spread to her chest and stomach. She sought help from the EMT who took her vitals (BP, HR, O2 sat), which were all normal, per the patient. She was observed closely by the EMT and medical review staff for about another 20 minutes. No treatment was given. The rash resolved on its own
38 2021-04-29 ringing in ears, deafness unilateral Temporary hearing loss, 1 ear. Tinnitus. Vertigo. Nausea
38 2021-04-30 toothache, taste disorder, sensitivity to light Severe and unbearable migraine Fever, profuse sweating Teeth hurt Extreme sensitivity to light Weird... Read more
Severe and unbearable migraine Fever, profuse sweating Teeth hurt Extreme sensitivity to light Weird taste and sensation in mouth Extreme exhaustion and weakness Chills and shivering Totally unable to function
38 2021-05-02 eye swelling, eye bleeding Swollen and bleeding eye
38 2021-05-03 fluid in middle ear, hearing loss Within 5 minutes of receiving the vaccine, she noticed a gradual decreasing of hearing in her left e... Read more
Within 5 minutes of receiving the vaccine, she noticed a gradual decreasing of hearing in her left ear. It sounded like when you have an ear infection when you cannot hear, without any popping or changes by positioning. No pain, but imbalance/dizziness which sent her to a clinic. She feels that she lost about 80-85% of her hearing on the left side. She was told that she had fluid in her ear - to go home take a decongestant and nasal spray. At 3 days, there was no improvement, so she went to her PCP. They examined her ear and did not see any fluid, but referred her to an ENT MD. As it would have taken more time to get in to see an ENT, she made an appointment with an audiologist. She saw the audiologist on 3/17/2021. Her hearing had returned by this time. The audiologist said she had seen several patients who had experienced hearing loss and about 50% had not had their hearing return. This client's hearing tested above average at this time.
38 2021-05-03 taste disorder Congestion, stuffy nose, store throat, things taste funny, fever x1 day, diarrhea Cough - ben... Read more
Congestion, stuffy nose, store throat, things taste funny, fever x1 day, diarrhea Cough - benzonatate (TESSALON) 100 mg capsule; Take 1 capsule (100 mg total) by mouth 3 (three) times a day as needed for cough for up to 7 days - guaiFENesin (MUCINEX) 600 mg 12 hr tablet; Take 2 tablets (1,200 mg total) by mouth 2 (two) times a day as needed for cough for up to 7 days
38 2021-05-03 vision blurred, extreme sound sensitivity, sensitivity to light extreme fatigue, dizziness (so much that i couldn't walk), sick to stomach, sensitivity to sound and... Read more
extreme fatigue, dizziness (so much that i couldn't walk), sick to stomach, sensitivity to sound and light, swollen lymph nodes (stilll have these), blurry vision, achy muscles
38 2021-05-04 taste impairment Sore arm at the time of shot and for 8 days after. Within 10 min of receiving the shot, I had a slig... Read more
Sore arm at the time of shot and for 8 days after. Within 10 min of receiving the shot, I had a slight metallic taste in my mouth. I had my second dose on 3/31/2021. My first menstrual cycle after the second dose began on 4/27/2021. I experienced painful cramping in my lower back about 1 week prior to my cycle starting and heavy bleeding and more painful than normal cramping on the day that I started my menstrual cycle.
38 2021-05-05 blindness Fever of 101.6, severe joint pain, dizziness, loss of vision, nausea, severe headache.
38 2021-05-05 eye itchiness sneezing and itchy eyes
38 2021-05-05 eye swelling Patient had feeling of neck pain during post injection surveillance. She returned to clinic for help... Read more
Patient had feeling of neck pain during post injection surveillance. She returned to clinic for help. C/O weak legs, tight chest. Patient led to bed for care. Face, arms very warm and flushed. VS @ 11:54: 147/97, 18, 118. VS stayed the same x 6 checks. 12:05pm: Zyrtec 10mg PO x 1 given. Redness reduced on face, arms. Some flushing remained on cheeks, eyes appear slightly swollen, though patient states she takes Prednisone 4 mg po Q day, also took her Flonase. 12:55pm: Ordered Diphenhydramine 25mgs po x 1. 1:10pm: Diphenhydramine po given. Continue to monitor. 1:30pm: Patient resting, feeling much improved. Denies any s&s. VS: remains hypertensive, tachycardic, although Mom states this is baseline, but will be addressed @ next f/u with Cardio. 1:55pm: Eyes improved- no more swelling, patient overall returned to baseline. Discharged home in stable condition with mother. If s7s return or worsen patient was instructed to go to nearest emergency department.
38 2021-05-05 mouth swelling, mouth tingling, canker sore, swollen gums, mouth itchiness During the 1st hour after receiving the vaccine my mouth had the same oral reaction I have when eati... Read more
During the 1st hour after receiving the vaccine my mouth had the same oral reaction I have when eating almonds. The roof of my mouth and gums became swollen, my lips tingled, on the soft palate there were small raised itchy bumps, the following day I had a few canker sores in my mouth. I immediately took my allergy pill, & I took a two non-steroidal naproxen pills. I continued taking my daily allergy pill and the naproxen about every 8 hours for two days. The swelling lasted about 3 to 5 days, the canker sores were better after 1 week. I kept monitoring my symptoms which improved on their own over time.
38 2021-05-06 ear pain, ringing in ears Dizzyness, vertigo, rapid heart rate, heart palpitations, slight chest pain, lightheadedness, slight... Read more
Dizzyness, vertigo, rapid heart rate, heart palpitations, slight chest pain, lightheadedness, slight ear pain, ringing in ears. All symptoms went away 4 days after first symptom except dizzyness, vertigo, and ear pain and ringing in ears.
38 2021-05-06 eye bleeding Burst blood eye vessel, my head felt hot for a few seconds. Felt light headed when I stood up.
38 2021-05-06 lip swelling Patient presented to the ED immediately after receiving COVID vaccination. Patient had shortness of ... Read more
Patient presented to the ED immediately after receiving COVID vaccination. Patient had shortness of breath, swelling to cheeks and lips, and it felt like her throat was swelling. Per nurse's note: Epi pen used to Right thigh and brought to the ER for further evaluate and monitoring. Epi seemed to help and by the time reached ER throat tightness was gone and breathing easier. Patient was prescribed and EpiPen, prednisone, and Pepcid. Epi pen was used a second time while in the ED. she was discharged home.
38 2021-05-07 mouth tingling Within 5-10 minutes of getting my Pfizer vaccine, I started to develop hives on my face, neck and ch... Read more
Within 5-10 minutes of getting my Pfizer vaccine, I started to develop hives on my face, neck and chest. My tongue and lips began to tingle and my throat ached/felt tight. Breathing was not affected. Was monitored for over an hour at CVS, and contacted my doctor who instructed me to take a Benadryl. The hives subsided but the tingling in my mouth and the aching in my throat remained. When I got home from CVS I took another Benadryl, a Claritin and a Zyrtec. Took a nap from 6:30-8:30 and woke up feeling a lot better. Started feeling the tightness in my throat again around 10:30, so I took another Benadryl
38 2021-05-07 swollen tongue, thirst swollen tongue; joint pain; inability to feel my right hand.; hands were very cold and clammy; thirs... Read more
swollen tongue; joint pain; inability to feel my right hand.; hands were very cold and clammy; thirst; trembling; arm soreness; I felt instantly dehydrated; had difficulty swallowing and breathing; had difficulty swallowing and breathing; throat tightness; This is a spontaneous report from a contactable consumer. A 38-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EW170 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 23Apr2021 19:45 (at the age of 38-years-old) as a single dose for covid-19 immunization. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium 75mg. The patient was not pregnant at the time of vaccination. It was unknown whether patient had any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021, 20:00, after inoculation of the 1st dose of the Pfizer COVID 19 vaccine, 'I felt instantly dehydrated, had difficulty swallowing and breathing'. After 30 mins, she felt a little better and went home. At about 21:30 she was able to breathe adequately but had throat tightness and arm soreness. The following day, at around 19:00, her symptoms re-occurred, only more seriously. She felt again swelling of her tongue, throat tightening, difficulty breathing, thirst, joint pain/trembling and inability to feel my right hand. Her hands were very cold and clammy. She sought emergency help at the Emergency room. The patient received treatment- decadron, benadryl, Pepcid. The seriousness of the event was considered as serious hospitalization by reporter consumer. Outcome of the events was unknown. Follow up needed, further information has been requested.
38 2021-05-07 ringing in ears EXTREME TINNITUS
38 2021-05-08 ear discomfort Itchyness on left side only of scalp, eyebrow, eye and forehead without any swelling or redness. Pre... Read more
Itchyness on left side only of scalp, eyebrow, eye and forehead without any swelling or redness. Pressure around the left ear and tiredness.
38 2021-05-08 ear pain Swollen lymph node in neck on the left side causing soreness in throat and left ear. Soreness is wor... Read more
Swollen lymph node in neck on the left side causing soreness in throat and left ear. Soreness is worse when laying down. Also experience breast pain in left breast and periodic burning sensation in left arm at vaccine site. Symptoms continue over a month after vaccine was administered. I am pregnant and was pregnant at the time of vaccination. Estimated due date is November 7th 2021.
38 2021-05-08 ringing in ears, ear discomfort, hearing loss 04/25-28/2021: blockage of right ear, audio distortion with severe headache 04/28-05/01/2021: tinnit... Read more
04/25-28/2021: blockage of right ear, audio distortion with severe headache 04/28-05/01/2021: tinnitus started on right ear, headace continues, blockage of right ear goes away 05/02-03/2021: blockage comes back again, ringing gets worse, audio distortion continues, headace, dizziness 05/04/2021: blockage dissapating, right ear ringing becomes multiple sounds, ringing starts in left ear as well 05/05/2021: ringing volume is increasing, mixed sounds 05/06/2021: blockage comes back, ringing in both ears continues with mixed sounds, went to PCP and checked ear, no infection or wax 05/07/2021: went to ENT doctor, did audiogram, no hearing loss confirmed, possibilty of inflamation symptoms due to vaccine by doctor, similar symptoms (minus tinnitus) were felt a year prior months after infected with covid, no prescription given Since April 25th, significant decreased function due to ear issue, unable to concentrate, tired, difficulty sleeping
38 2021-05-09 loss of smell Stomach Complaints, Vaccine Side Effects LOSE OF SMELL
38 2021-05-09 eye swelling, bloodshot eyes, swollen lips, eye itchiness On 4/28 had fever of 100.7, joint pain, tired and sick. On 5/3 began having a reaction on chest, ch... Read more
On 4/28 had fever of 100.7, joint pain, tired and sick. On 5/3 began having a reaction on chest, chin line, eyes, and lips. I have itchy bumps on these areas of my body and some sores on my chest. My eyes are itchy and have dry patches around the eye. They are also red and swollen.
38 2021-05-09 eye swelling Severe pain on right forehead starting 5/2/2021. Rash on forehead with pain starting 5/3/2021. Blist... Read more
Severe pain on right forehead starting 5/2/2021. Rash on forehead with pain starting 5/3/2021. Blisters on rash, body aches, fatigue, fever of 101 starting 5/5/21. Virtual appt with physician on 5/5/21, diagnosed as shingles (uncomplicated), started 7 days of antiviral medication and OTC pain relief (1000 mg XStrength Tylenol 3x daily). Rash spread to area around right eye starting 5/6/21. Eye partially swollen shut, continued fever 5/7/21. Follow-up virtual appt with physician 5/7/21, recommended in-person urgent care or ER. ER visit 5/7, administered anti-inflammatory injection and oral (liquid) steroid. Continued antiviral medication and prescribed percoset, amitriptyline, and dexamethasone. Fever and facial swelling reduced by 5/8. Rash, pain, fatigue still present 5/10.
38 2021-05-09 feeling of choking Patient began to experience tingling in her throat, no swelling or shortness of breath. At the same... Read more
Patient began to experience tingling in her throat, no swelling or shortness of breath. At the same time she began to experience a hot sensation in her throat and ears. Patient was given 25 mg of diphenhydramine along with water. Patients blood pressure, pulse, and oxygen levels were normal. Patient was also given ice pack to place on her throat and chest. Patient rested for about 1 hour and then left on her own, accompanied by her mother.
38 2021-05-11 eye swelling Swelling of right undereye area the morning after COVID-19 vaccine (approximately 23 hours after vac... Read more
Swelling of right undereye area the morning after COVID-19 vaccine (approximately 23 hours after vaccine). History of dermal fillers in mid-face area one year ago.
38 2021-05-11 painful gums, mouth ulceration, pain in jaw, lip swelling Swollen lips, redness on gums, tenderness on gums, pain in jaw, ulcer type rash in mouth, headache. ... Read more
Swollen lips, redness on gums, tenderness on gums, pain in jaw, ulcer type rash in mouth, headache. Treated with steroids and allergy medicine.
38 2021-05-12 eye pain, vision blurred Acute multifocal posterior placoid epitheliopathy right > left eye. eye pain and center vision hazin... Read more
Acute multifocal posterior placoid epitheliopathy right > left eye. eye pain and center vision haziness (as if she just got a camera flash in her eye)
38 2021-05-12 mouth numbness Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: tip of tongue got n... Read more
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: tip of tongue got numb after waiting for about 10 minutes after receiving the vaccine. she explained it like it feeling as though she drank hot coffee and burnt the tip of her tongue. she said she felt fine besides that and decided to leave.
38 2021-05-12 mouth numbness Systemic: Allergic: Rash Generalized-Mild, Systemic: Numbness (specify: facial area, extremities)-Mi... Read more
Systemic: Allergic: Rash Generalized-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: pt stated that about 3 days after her first vaccine the tip of her tongue got numb and she got a rash on her chest. the numbness of the tongue only lasted a few hours and the rash was gone by the next day. about a week after her first vaccine, she started getting pain in her toes and then in her inner thighs. the pain lasted for about a week. she took some ibuprofen when the pain first started which she said helped a little, but then didn't take anymore. she said the pain wasn't bad at all
38 2021-05-12 ringing in ears Ringing in ears
38 2021-05-13 swollen tongue PATIENT REPORTED DIZZINESS, NAUSEA, TONGUE/THROAT SWELLING SENSATION, FLUSHING, CHEST PRESSURE, CHES... Read more
PATIENT REPORTED DIZZINESS, NAUSEA, TONGUE/THROAT SWELLING SENSATION, FLUSHING, CHEST PRESSURE, CHEST PAIN. ANAPHYLAXIS. CALLED 911 . ADMINISTERED EPIPEN INJECTION. TRANSPORTED TO HOSPITAL BY PARAMEDIC.
38 2021-05-13 ringing in ears Tinnitus, dizziness, headache
38 2021-05-13 vision blurred PATIENT EXPERIENCE BLURRED VISION AND LIGHT HEADEDNESS IMMEDIATLEY AFTER VACCINATION. A WEEK FOLLOW... Read more
PATIENT EXPERIENCE BLURRED VISION AND LIGHT HEADEDNESS IMMEDIATLEY AFTER VACCINATION. A WEEK FOLLOWING DURING PATIENT MENSES SHE EXPERIENCED EXTREMELY HEAVY AND UNUSUAL BLEEDING.
38 2021-05-14 loss of taste Loss my sense of taste completely the day after I received my second vaccine. As of today it's been ... Read more
Loss my sense of taste completely the day after I received my second vaccine. As of today it's been 20 days, no change in symptom.
38 2021-05-14 taste impairment Increasing foot pain on the second day of the injection, tiredness and weakness. The foot pain conti... Read more
Increasing foot pain on the second day of the injection, tiredness and weakness. The foot pain continued then my spine and my feet got numbed. My hands, my lower lip and several parts of my body got numbed. The pain in the spine does not subside, I had a bitter or metallic taste in the mouth and moderate diarrhea.
38 2021-05-14 visual impairment, ringing in ears Tinnitus in one ear at a time, but affecting both ears. Intermittent Vertigo. Small slightly raised ... Read more
Tinnitus in one ear at a time, but affecting both ears. Intermittent Vertigo. Small slightly raised red spots that are not itchy, located under arm pits, and on neck. Black spots in vision that come and go.
38 2021-05-15 dry mouth After Pfizer vaccine administration symptoms started burping, nausea, lightheaded, nasal congestio... Read more
After Pfizer vaccine administration symptoms started burping, nausea, lightheaded, nasal congestion, dry mouth which developed 3 minutes after COVID-19 vaccination and did not resolve. I provided a copy of Allergist note with her for clearance given noted allergies to polysorbate et al for which I get dry mouth , itchiness, vomiting and nausea. Since nausea, burping and wretching did not resolve after an hour , EMS activated for further eval, treatment and monitoring in the ED. given Zofran by EMS with prior to transport to ED.
38 2021-05-15 ringing in ears 39 Weeks and 1 day pregnant, estimated due date May 20, 2021. One previous successful pregnancy. Rea... Read more
39 Weeks and 1 day pregnant, estimated due date May 20, 2021. One previous successful pregnancy. Reaction to first shot, sore arm. Reaction to second shot: Vomiting, fever (99.9), lethargy, throbbing joints, headache, tinnitus, 36 hours of nausea, tiredness, sore arm and sweating.
38 2021-05-17 feeling of choking Patient developed mild tingling in the throat which lasted 24 hours but resolved and was not associa... Read more
Patient developed mild tingling in the throat which lasted 24 hours but resolved and was not associated with any angioedema. She had some transient joint discomfort. Here menses arrived a few days early. Approximately April 26th she developed supraclavicular/ paratracheal enlarged lymph nodes which would be worse in the early morning and late afternoon. symptoms would radiate to her hear and cause discomfort with eating.
38 2021-05-17 vision blurred Patient received in RN triage area, post-COVID vaccination administration. Patient being observed fo... Read more
Patient received in RN triage area, post-COVID vaccination administration. Patient being observed for 15 minutes as recommended per CDC guidelines on post-vaccination RN monitoring. Patient approached nurses stating that she felt nauseous and lightheaded. Patient noted diaphoretic, and pale in color; while helping patient to the wheelchair the patient fainted and was completed unconscious. Patient guided to floor by staff. Patient was unconscious for about a minute while on floor. RRT called. When patient came to patient reporting lightheadedness, blurred vision. Vitals 09:11: BP: 103/62, HR: 63, O2: 96%. Patient denies any history of syncope or fainting. Patient stated that she had not had anything to eat this morning. Denies any Hx of anaphylactic reaction to vaccines. Patient denies adverse reactions to vaccinations in past. Tolerated injection well. Patient sent to ER with RRT . All questions and concerns addressed.
38 2021-05-18 loss of taste, sensitivity to light I started having a headache the same day non stop, nausea and light dizziness, sensitivity to bright... Read more
I started having a headache the same day non stop, nausea and light dizziness, sensitivity to bright lights and a week after the vaccine I lost my sense of taste on my right side of my mouth. April 25th I woke up to my right side of my face paralyzed and rushed to the ER. I was diagnosed with Bell's Palsy
38 2021-05-18 fluid in middle ear Fluid in the ears - creating a ?clicking? noise. Doctor described as Eustachian Tube Dysfunction.
38 2021-05-18 sensitivity to light Foggy mind ever since first shot, alone with aches and weakness, followed by scull and scalp pain on... Read more
Foggy mind ever since first shot, alone with aches and weakness, followed by scull and scalp pain on my right side, and then terrible vertigo and light sensitiv on 5/18/21
38 2021-05-19 ear discomfort, ear congestion, ear infection pain reached her neck; had sore throat; feeling congestion/inflammation/pressure in my left ear; fee... Read more
pain reached her neck; had sore throat; feeling congestion/inflammation/pressure in my left ear; feeling congestion/inflammation/pressure in my left ear; feeling congestion/inflammation/pressure in my left ear; the inflammation/pressure grew to my right year and all over my head; it felt very swollen; pain in my arm; pain grew to my armpit; side of the left breast, and up to the clavicle; side of the left breast, and up to the clavicle; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173), dose 1 via an unspecified route of administration in left arm on 01May2021 at 11:00 as 1st dose single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included vitamin d nos, iron, vitamins nos, thyroid. No other vaccine in 4 week, no prior vaccination Covid testing and no post vaccination Covid tested. On 03May2021, the patient experienced pain in my arm, pain grew to my armpit, side of the left breast and up to the clavicle, it felt very swollen and on 05May2021 experienced feeling congestion/inflammation/pressure in my left ear, the inflammation/pressure grew to my right year and all over my head and pain reached her neck and had sore throat. As resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the event pain in my arm, pain grew to my armpit, side of the left breast, and up to the clavicle recovered on 07May2021 and feeling congestion/inflammation/pressure in my left ear the inflammation/pressure grew to my right year and all over my head, it felt very swollen, pain reached her neck and had sore throat were not recovered. No follow-up attempts are needed. No further information is expected.
38 2021-05-19 mouth itchiness, mouth tingling, lip itchiness Tingly/itchy face especially around thelips and tongue; Tingly/itchy face especially around the lips... Read more
Tingly/itchy face especially around thelips and tongue; Tingly/itchy face especially around the lips and tongue.; Tingly/itchy face especially around the lips and tongue.; This is a spontaneous report received from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the one dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; EN6208) via an unspecified route of administration in Left arm on 13Mar2021 at 10:30 am (at the age of 38-year) as a single dose for COVID-19 Immunization. The patient's medical history was not reported. Allergies to medications, food, or other product reported towards Peaches (any fuzzy fruit). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021 at 09:00 am, the patient experienced Tingly/itchy face especially around the lips and tongue (Lip itching, Oral pruritus and Tingling mouth). The patient did not receive any treatment for the events. The clinical outcomes for Tingly/itchy face especially around the lips and tongue was not recovered. No follow-up attempts are needed. No further information is expected.
38 2021-05-20 mouth tingling Patient received the vaccine at 2:55pm and returned 30 min later stating soreness at the injection a... Read more
Patient received the vaccine at 2:55pm and returned 30 min later stating soreness at the injection and having headache and tongue is tingling. RXM gave her 2 Benadryl and water.
38 2021-05-24 mouth numbness Client complained of numbing feeling to throat and tongue. Able to drink fluids without difficulty. ... Read more
Client complained of numbing feeling to throat and tongue. Able to drink fluids without difficulty. No stridor noted 02 Sats 100%. Made aware to follow-up with MD if symptoms persist and call 911 if symptoms worsen.
38 2021-05-25 mouth numbness Noticed intermittent tingling/numbness in lips, arm and fingers a little over a month after receivin... Read more
Noticed intermittent tingling/numbness in lips, arm and fingers a little over a month after receiving the second dose. Also intermittent vertigo on same timeline.
38 2021-05-26 ear pain Swelling under arm and near left breast - felt internal mass becoming enlarged, difficulty swallowin... Read more
Swelling under arm and near left breast - felt internal mass becoming enlarged, difficulty swallowing, soreness in entire left arm, and continuing up left side into shoulder area and neck and ear area. Tiredness, foggy brain, lathagic feeling, and slightly aches around armpit area.
38 2021-05-26 mouth tingling The monitoring nurse observed client with elevated hand, reported feeling "tingling to hands, lip, f... Read more
The monitoring nurse observed client with elevated hand, reported feeling "tingling to hands, lip, feet". No signs of acute distress. Patient denied any respitory difficulty, and there were no signs of anaphylactic reactions. Skin clammy to touch. Patient felt nausea, so was assisted to clinic restroom and had 2 vomiting episodes. Vital signs b/p 123/86, pulse 84, resp. rate 22, O2 sats 99% After continued observation, dizziness and nausea subsided. Felt comfortable enough to leave clinic Vital signs b/p 119/87, pulse 76, resp. rate 22, O2 sats 97%
38 2021-05-26 ringing in ears, oropharyngeal discomfort problem with her throat; Ears were ringing; turned red on her neck and her chest, it was not like hi... Read more
problem with her throat; Ears were ringing; turned red on her neck and her chest, it was not like hives, but it was as if someone had slapped her; felt an intense heat in her chest and throat; This is a spontaneous report from a contactable registered nurse (the patient's mother). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 10May2021 (at the age of 38-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: reflux, "weird allergy" that had popped up before and caused Steven Johnson Syndrome (further clarification unknown). Concomitant medication included an unspecified reflux medicine. The patient daughter received the first dose of the Pfizer BioNtech COVID-19 vaccine yesterday (10May2021), and she had a problem with her throat (May2021). She took diphenhydramine hydrochloride (BENADRYL), and it was resolved after an hour (treatment). The patient's mother also specified that the patient felt an intense heat in her chest and throat, and her ears were ringing (both May2021). The patient turned red on her neck and her chest, it was not like hives, but it was as if someone had slapped her (May2021). At the vaccination site, they were able to put an ice bag on her neck and on her chest, and it resolved afterward, after an hour, so ice was applied for an hour as well. The symptoms resolved at the time over there (at the center where the vaccine was given), and they gave her BENADRYL. The patient's weight was maybe in the 150 range. The outcome of the events was resolved in May2021. Information on Lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-05-27 taste disorder The client received her vaccination and then reported changes in taste approximately 10 minutes afte... Read more
The client received her vaccination and then reported changes in taste approximately 10 minutes after being vaccinated. She then vomited x6 in the parking lot. This resolved with apple juice and crackers. On 5/28 client has reporting fatigue and continued vomiting the day after her vaccination. recommended to continue monitoring and seek medical attention if necessary.
38 2021-05-28 eye irritation Fever 101.7F, severe weakness, headache, body aches, chills, heat waves, burning eyes, painful (not... Read more
Fever 101.7F, severe weakness, headache, body aches, chills, heat waves, burning eyes, painful (not sore) L arm at the injection site
38 2021-05-28 ringing in ears One day after receiving 2nd vaccine shot in left arm, I had tinnitus in left ear for about 10-15 sec... Read more
One day after receiving 2nd vaccine shot in left arm, I had tinnitus in left ear for about 10-15 seconds and the lymph nodes in my left underarm became swollen and painful. The following day, my underarm area is still swollen but less painful. Experienced tinnitus again at around 5 p.m. in my left ear for about 5 seconds. I am reporting this because tinnitus is not listed as a common side effect.
38 2021-05-28 ringing in ears Tinnitus in both ears; This is a spontaneous report from a contactable consumer (patient). A 38-year... Read more
Tinnitus in both ears; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EWO 153), via an unspecified route of administration, administered in Arm Left on 20Apr2021 12:45 (received at the age of 38-years-old) as 2ND DOSE, SINGLE for COVID-19 immunization. The vaccine was administered at a pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hashimoto's and allergy to penicillin. The patient was not pregnant. Concomitant medications included vilazodone hydrochloride (VIIBRYD) taken for an unspecified indication, start and stop date were not reported; clonazepam (KLONOPIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8734), in the left arm, on 30Mar2021 12:45 for COVID-19 immunization. The patient experienced tinnitus in both ears that has not stopped since the day after her 2nd vaccine, on 21Apr2021: 10:00. The adverse event resulted into a doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 post vaccination. Outcome of the event was not recovered. The adverse event was assessed serious (disability).
38 2021-05-29 lip swelling Wednesday morning at 2 am, I broke out into itching hives all over my chest, stomach and under arm p... Read more
Wednesday morning at 2 am, I broke out into itching hives all over my chest, stomach and under arm pits. I took a Claritin and applied Benadryl cream. They were gone when I woke up that morning. Around 3pm that afternoon, my neck started itching. By the time I got off of work at 5pm, my entire neck had broken out in hives and there were hives forming near both of my eyes. When I got home, my face had swelled and I was also breaking out on my arms, chest, stomach and upper thighs. I went to the hospital where they treated me for an allergy. I was given prednisone and Pepcid, a prescription for an EpiPen, and then told to take Benadryl and apply hydrocortisone cream which I had to purchase myself. I took two Benadryls that night and applied the cream and the hives were gone by the morning. Thursday, around 4 pm, my chest and stomach started itching. I came home and took 2 Benedryls, and a cold shower to help relieve the itch. I applied the hydrocortisone cream and took a nap. I woke up 3 hours later, itching again, this time all over my arms, face, thighs and back. My lips had swollen and my ears were itchy and red. I called the urgent care number and was instructed by a doctor to come into the facility since my lips were swollen. When I arrived, I was given a steroid (name unknown), Pepcid and Benadryl through IV. The hives did not respond right away and in fact because to spread further after treatment. After 2 steroid shots, they finally went away, though my lips were still slightly swollen. I was given a prescription for Prednisone and sent home. Saturday morning, my arms and chest began to itch and turn red. I applied hydrocortisone cream, took 2 Benadryls and the Prednisone as prescribed. The itching subsided after an hour, but the redness remained the rest of the day. As I am typing this on Sunday morning, I still have redness over my chest, stomach and arms, but no itching.
38 2021-05-31 canker sore, thirst, taste impairment Metallic Mint Taste, canker sore on tongue, dizziness/faint, increased bpm (beats per minute), face ... Read more
Metallic Mint Taste, canker sore on tongue, dizziness/faint, increased bpm (beats per minute), face was hot and burning after working out (1 day and ongoing after), can't quench my thirst, and throat felt tight.
38 2021-06-01 hearing loss, ringing in ears Tinnitus ringing in right ear and muffled left ear. Not subsiding after 16hrs
38 2021-06-02 lip blister Since becoming fully vaccinated, I've had two viral infections or episodes physically triggered. One... Read more
Since becoming fully vaccinated, I've had two viral infections or episodes physically triggered. One was an upper respiratory illness which was mistreated with antibiotics as a bacterial infection. This latest viral episode manifests itself with fever blisters on my upper lip, fatigue, stomach pain, body aches, dehydration. It could've been triggered by excessive sun exposure, but fever blisters are not reoccurring whatsoever for me. Both of these incidences are atypical for my body. I suspect either I'm temporarily & mildly immunocompromised. Or I'm experiencing a hyper immune system that is overreacting to the presence of dormant viruses. It's in "fighting mode."
38 2021-06-02 swollen tongue - Dizziness / feeling of dis-ease within 15-30 mins following shot - Some face swelling and rednes... Read more
- Dizziness / feeling of dis-ease within 15-30 mins following shot - Some face swelling and redness, hot to touch within first hour with itchiness - swelling and redness similar to a bad sunburn - itchiness spread down neck and eventually to whole body and lasted for around 5-6 days - Nausea / general discomfort within first hour - swelling feeling in my calves and feet like I was retaining water the first night after the shot, lasted a few days - what felt like swelling / tightness in throat - felt like the back of my tongue was swelling a bit / harder to swallow - extremely swollen lymph node at left collar bone - noticeably swollen lymph node under left arm area
38 2021-06-05 taste impairment METALLIC TASTE IN MOUTH STARTING THE DAY AFTER VACCINATION, AND HAS CONTINUED SINCE THEN.
38 2021-06-05 eye movement disorder, lacrimation increased, sensitivity to light Once I got the vaccine my right arm had been sore but on the second day of having it I felt the righ... Read more
Once I got the vaccine my right arm had been sore but on the second day of having it I felt the right side of my face not function properly. The right side of my face had gotten swollen and felt numb. My right eye was slower at closing compared to the left one. It would water and was sensitive to any wind or light. My mouth seemed to go off on one side when I'd speak and my right ear was in pain.
38 2021-06-07 taste impairment Metal taste in mouth; dizzy; headache; nausea; hot / cold; brain fog; exhausted feeling; This is a s... Read more
Metal taste in mouth; dizzy; headache; nausea; hot / cold; brain fog; exhausted feeling; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of BNT162B2 (Lot number was not reported), via an unspecified route of administration, administered in left arm on 10Mar2021 09:45 (at the age of 38-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history included ADHD, psoriasis, multiple joint arthritis and allergies. The patient's concomitant medications were not reported. On 10Mar2021 at 11:15 AM, the patient experienced metal taste in mouth, dizzy, headache, nausea, hot / cold, brain fog, and exhausted feeling. It was unknown if there are treatment received for the events. No Covid prior vaccination. Covid not tested post vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
38 2021-06-07 lip swelling Bilateral lip swelling
38 2021-06-10 ringing in ears 1st shot on 05/13/2021: in the next 24 hours, taste changed. It eventually went away 2nd shot on 06/... Read more
1st shot on 05/13/2021: in the next 24 hours, taste changed. It eventually went away 2nd shot on 06/03/2021: in the next 48 hours, ear whooshing sound and nosebleed. It eventually went away
38 2021-06-10 vision blurred, visual impairment I called off work on 01/08/2021 and I woke up that morning around 2 am with a headache and fever of... Read more
I called off work on 01/08/2021 and I woke up that morning around 2 am with a headache and fever of 102.7. The headaches never went away and they were very persistent and pulsating. I made an appointment with my PCP on 01/18/2021 at 11 AM and at this point I was getting very dizzy and nauseous. I made another appointment with my psych Doctor to make sure it wasn't an interaction with the medication I was taking. He said it shouldn't cause interaction. PCP wanted me to see Neurology and schedule for an MRI. I continued to work and was taking Motrin and Tylenol. The Headaches were still persistent. By February I seen an Opthomologist because I was having blurred vision and still had pulsating on the left side of head. He said I had increased intracranial pressure and he asked about any history of glaucoma. He had me on these eye drops to decrease eye pressure on 02/08/2021. I had a F/U on 02/16/2021 with my other psych Doctor because I still felt the same. I had another follow up with PCP on 02/23/2021. I seen the neurologist on 03/12/2021 and the the pressure was getting worse and worse by this point and people were noticing at work that I was not myself. I had vision changes and blurred vision. The Neurologist stated that he does believe the vaccine plays apart in this. He said I have intracranial hypertension and would need spinal tap. On the 02/13/2021 I was at work I threw up because I was so dizzy. I went to ER and they could not do a spinal tap so they ended up doing a spinal tap on the 02/14/2021 and they removed fluid and I had instant relief from that. I was discharged on 02/17/2021and pretty much once they removed that fluid I felt better. I still have subtle headaches but something did happen to me where I had increased intracranial pressure. I had a follow-up on the 02/23/2021 and follow up 03/31/2021 with Dr. and things were starting to resolve and get better. Neuro has me on medication for fluid on brain (diuretic) and Topamax for the headaches. MRI was done on 03/01/2021.
38 2021-06-14 blindness, vision blurred After the shot, I could not see. Everything was blurry. My fingers became numb and my feet were swol... Read more
After the shot, I could not see. Everything was blurry. My fingers became numb and my feet were swollen
38 2021-06-14 eye discomfort, eye pain So prior to the vaccine I did have glaucoma which was controlled by eye drops. But then at the end o... Read more
So prior to the vaccine I did have glaucoma which was controlled by eye drops. But then at the end of April, beginning of March I started to have pain and pressure in my eyes. I saw my eye DR and he gave me more eye drops and scheduled a surgery on my eyes. My eye pressure was 39. On the 9th of March 2021 I had surgery on my eye. I had another surgery on April 13 2021 as well.
38 2021-06-15 taste impairment Light headed, nauseous, metallic taste in mouth, dull/numbing pain in entire arm except burning sens... Read more
Light headed, nauseous, metallic taste in mouth, dull/numbing pain in entire arm except burning sensation at injection site.
38 2021-06-15 eye pain, eye floaters -10 min after vaccine, saw spots and was dizzy almost passed out nurses had to run over and put ice ... Read more
-10 min after vaccine, saw spots and was dizzy almost passed out nurses had to run over and put ice on my neck and put my head in between my legs. they had to keep me at the clinic for 45 min and they checked my blood pressure and it was elevated. that night I had horrible back spasms - next day had numbness and tingling in my left arm, headace stabbing pain in right eye. sore breasts, spotting , racing heart, elevated blood pressure numbness lasted for two days, all other symptoms have continued every day and I am on day 5
38 2021-06-16 eye swelling swelling on her right eye; This is a spontaneous report from a contactable consumer(spouse). A 38-ye... Read more
swelling on her right eye; This is a spontaneous report from a contactable consumer(spouse). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0173; Expiration date was not reported), via unspecified route of administration in the left arm on 11May2021 17:30 (at the age of 38-years-old) as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0162; Expiration date was not reported), via unspecified route of administration in the left arm on 20Apr2021 05:00PM (at the age of 38-years-old) as first dose, single dose for COVID-19 immunisation. On 13May2021 at night, the patient experienced the swelling on the right eye. The outcome of the event was not recovered. The reporter wanted to understand if any action needs to be taken and asked if this was normal and expected and how to go about it. No follow-up attempts are possible. No further information is expected.
38 2021-06-20 eye itchiness, bloodshot eyes, eye swelling 1. Day 1 -- Immediately started feeling dizziness, weakness and sickness. I can not think clearly.... Read more
1. Day 1 -- Immediately started feeling dizziness, weakness and sickness. I can not think clearly. My body was cold. Too weak and dizzy to walk. I stayed in a bed for about 40 minutes. Couldn't drive, At that night I had pains all over my body. 2. Day 2 -- Still felt dizzy and had mild allergic reaction: my eye areas were reded, swallowed a little and itchiness on my eyes and around them. See floats. Still couldn't drive cos of the dizziness. 3. Day 3 -- Still feeling dizzy and tired. Floats are almost gone.
38 2021-06-20 visual impairment Seven minutes after the patient received the Pfizer Dose 1 COVID-19 vaccination, patient started to ... Read more
Seven minutes after the patient received the Pfizer Dose 1 COVID-19 vaccination, patient started to feel nervous and hot. While waiting to receive some water she started complaining of being dizzy and wanted to lie down. The pharmacist escorted her to the immunization area and the patient became weak and started loosing her balance. She was put in a sitting position on the floor with her legs out. She then went into a blank stare to the ground, her hands flexed to her side, and wet herself. She became alert within seconds and was talking and acting normally. We called EMS and they transferred her to an emergency room for evaluation.
38 2021-06-21 mouth numbness On day 10 I experienced numb tongue, symptoms became worse the following day. I reported to the ER ... Read more
On day 10 I experienced numb tongue, symptoms became worse the following day. I reported to the ER and was diagnosed with Bells Palsy. Not sure vaccine had anything to do with it.
38 2021-06-24 dry mouth Chief complaint: Syncope. The patient was seen on paramedic arrival to room #2 with the above chie... Read more
Chief complaint: Syncope. The patient was seen on paramedic arrival to room #2 with the above chief complaint. She is a very pleasant otherwise healthy 38-year-old woman who had been in her usual state of health. Today she felt a little lightheaded, laid down on the floor in her kitchen, and had a syncopal spell. This occurred roughly an hour prior to arrival and lasted just a few minutes. When her mother arrived she stated that she had witnessed the spell and that the patient was tonic but not having seizure-like activity. She was completely unresponsive and confused afterwards but not incontinent. She is describing nausea but no chest discomfort. She has had no vomiting or diarrhea and no diaphoresis. She denies prior similar symptoms and has no history of seizure, heart disease, VTE, or reactive airway disease. She does feel like she has a dry mouth and also feels improved at this time. She is not on medications chronically. She did have her second COVID-19 vaccination yesterday with some mild arthralgias but nothing else. She was seen by the paramedics and noted to be having dropped beats. An EKG was obtained and during transport she went into a complete heart block with resumption of sinus rhythm afterwards. The EMS rhythm strip was reviewed by myself and does reveal transient complete heart block. DETAILS OF HOSPITAL STAY Hospital Course Summary Patient is an 38 y.o. female w/ no significant PMHx who presented to the ED via EMS after a syncopal episode. She was standing in the kitchen, felt lightheaded then fell to the floor and passed out. Her mother subsequently arrived and witnessed an additional episode of of unresponsiveness. EMS subsequently caught on telemetry multiple episodes of complete heart block. The longest of these lasted 20 seconds. She was referred for admission. The interested reader is referred to the complete admission history and physical. Patient is admitted to the hospital. Pacer pads were placed. On monitor she had no further symptoms nor pauses. Cardiology consulted. Echocardiogram was performed and was normal. It was ultimately felt that the patient most likely experienced a vagal event with marked suppression of AV conduction. Of note, patient received her second Pfizer COVID-19 vaccination the day prior. Cardiology has recommended discharge home with a Zio patch. Lengthy discussion has been held with patient regarding importance of immediately activating EMS should she have recurrent symptoms similar to what brought her in. Patient was also noted to have a microcytic anemia. Iron studies returned remarkable for severe iron deficiency. She received 1 dose of IV iron in the hospital and is discharged with twice daily oral iron. She is to follow-up with her PCP for ongoing monitoring and evaluation. In addition, she should lay down immediately.
38 2021-06-25 mouth swelling, swollen tongue, swelling of eyelid Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Mild, Additi... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Mild, Additional Details: patient reported swelling in eyelids and the whole area around the eye that started wednesday 6/23; 2 days after pfizer 1st shot, pt. went to an urgent care that prescribed the patients triamcinolone 0.025% cream to apply to affected area. pt reported swelling reduction after treatment but on friday that the right eye started to swell up as well but not as bad as the left. no vision changes has been reported, Pt is to follow up with an eye doctor next week.
38 2021-06-25 pain in jaw Pt reported neck discomfort starting within 10 minutes of second vaccine dose, progressed to right s... Read more
Pt reported neck discomfort starting within 10 minutes of second vaccine dose, progressed to right submandibular pain over the next few weeks clinically consistent with sialoadenitis. Patient subsequently had a severe viral UTI a month after the vaccine and developed symptoms of hyperthyroidism following the viral URI. Patient was subsequently diagnosed with thyroiditis.
38 2021-06-27 lip swelling, mouth numbness The inside of my mouth went numb, then my whole face went numb. I broke out with hives on my chest, ... Read more
The inside of my mouth went numb, then my whole face went numb. I broke out with hives on my chest, My lips started to swell, and my throat started to close. My blood pressure shot to the roof.
38 2021-06-28 eye strain, drooling Dose 1: I went out to eat after and on the drive home, I started to feel weird. Almost like I should... Read more
Dose 1: I went out to eat after and on the drive home, I started to feel weird. Almost like I shouldn?t be driving. Foggy, tired, eye lids were heavy, almost felt drunk or withdrawing from drugs. (Similar to when I was prescribed Cymbalta and forgot to take one, years ago. But much worse.) I went home and laid down. My heart was racing. I felt nauseous. I didn?t feel like I had control over my thoughts, if that makes sense. My chest hurt. My mouth was watering. It was scary. I slept for 11.5 hours, on and off. I had a hard time staying asleep. I woke up in the morning feeling much better, but my arm hurt pretty bad and I was still exhausted and nauseous. I stayed home from work. The next day, I felt more myself, but my arm still hurt. Dose 2: I expected to feel the same or even worse after this dose, so I planned to go straight home and lay down and took the following day off from work in advance. I went straight home and waited, but I felt fine. I went to bed at my normal time. Slept fine. Woke up fine. I thought I got lucky. I called and told work that I?d be in. I had a calm morning, but then we did a fire drill at 9:45am or so. After the fire drill, I started to feel weird again. All of the same symptoms. By 10:30, I told my boss I needed to leave. I felt paranoid. I had a couple hallucinations. I was falling asleep. I was scared to be working. I felt guilty for putting my boss in this predicament. I wasn?t able to get coverage until about 1pm. By then, I was terrified of driving home, but forced myself to. I live 2 minutes away. I told my kids that I didn?t feel well and went to sleep. My heart was racing. All of the same symptoms plus these, but all heightened. I kept telling myself that they would go away. I just needed to sleep. So, I did. Again on and off, it was hard to stay asleep. My Fitbit showed that my heart rate was elevated once the symptoms started and the entire time I was sleeping. I woke up feeling exhausted again. Nauseous. This time, my arm felt like I was shot with a gun. I took the day off from work. My arm actually still doesn?t feel the same today.
38 2021-06-29 eye swelling Swollen eyes with rash; Swollen eyes with rash; This is a spontaneous report from a contactable cons... Read more
Swollen eyes with rash; Swollen eyes with rash; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in left arm on 19Mar2021 at 10:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to amoxicillin-m. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications taken within two weeks of vaccination included CLARITIN-D and spironolactone (MANUFACTURER UNKNOWN) both for unknown indication and from an unknown date. The patient experienced swollen eyes with rash on 20Mar2021 at 15:00. No Therapeutic measures were taken for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen eyes and rash was not recovered. No follow-up attempts are needed. No further information is expected.
38 2021-06-29 feeling of choking, mouth tingling, hearing loss, dry throat, ringing in ears 30 minutes after first Covid jab she experienced tachycardia, tingling in neck and chest. Her legs g... Read more
30 minutes after first Covid jab she experienced tachycardia, tingling in neck and chest. Her legs gave out when she got home and she felt unwell for the rest of the day, but recovered. Second Covid jab was on 4/11/21 and she felt her throat close up afterwards. Numbness in toes, feet, thighs and hand, felt tingling in throat, tongue and face. She took prednisone taper and experienced hip and knee pain, then took ibuprofen, which caused chest discomfort. Since then she has lost 8# because of dryness in throat and tightness in throat when she tries to swallow or eat. Feels short of breath although pulse ox readings have been normal. Fatigue and light-headedness with some reduced hearing and tinnitus. Symptoms are gradually improving after visits to primary care, neurologist and cardiologist. Still experiences heart pounding when she stands up first thing in the morning and light-headedness. Also experiences heart pounding when she eats. Sometimes pounding in the middle of the night that wake her up from sleep. Tingling in arms and legs continues.
38 2021-06-29 thirst menstrual cycle started 8-9 days later than expected. almost 4 weeks after second dose and still fee... Read more
menstrual cycle started 8-9 days later than expected. almost 4 weeks after second dose and still feel pain in lower right back side, worse in the morning. constantly feel thirsty, drinking 2.5-3L of water a day and still thirsty(wasn't experiencing the same before vaccine)
38 2021-06-29 tongue discomfort, swollen tongue 2 circle rash one on chin n one on chest.; Itching all over body; Tongue felt heavy; Tongue swollen;... Read more
2 circle rash one on chin n one on chest.; Itching all over body; Tongue felt heavy; Tongue swollen; Difficulty breathing normal at night; Headaches; This is a spontaneous report received from a contactable health care professional, the patient. A 38-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 08:15 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. No relevant medical history was provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No concomitant medications were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any medications within 2 weeks of vaccination. On 18Mar2021 at 23:00, the patient experienced 2 circle rash one on chin and one on chest, itching all over body, tongue felt heavy and swollen, experienced headaches for 2 days and difficulty breathing which was normal at night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received as a result of the adverse events. The clinical outcome of event headache was resolved while the outcome of events spot-like rash, itching, tongue discomfort, swollen tongue and difficulty breathing was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
38 2021-06-30 ear pain inflammation symptoms- left clavicle pain; general neck pain; area above left ear hurts when touched... Read more
inflammation symptoms- left clavicle pain; general neck pain; area above left ear hurts when touched; migraine on 2nd day; This is a spontaneous report from a non contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 16:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history included migraine, hypoglycemia, and obese with chronic inflammation issues like neck pain . The patient had allergies to dog and mold as well as severe seasonal allergies, also she had no known drug allergy. The concomitant medications within two weeks included cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE), ibuprofen (MANUFACTURER UNKNOWN) for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced migraine on 20Mar2021, inflammation symptoms-left clavicle pain (shoulder pain), general neck pain, area above left ear hurts when touched (ear pain) on 21Mar2021 at 20.00. It was 4-day delayed reaction. The patient was obese with chronic inflammation issues like neck pain. The notable pain on end of clavicle closest to arm and horrific pain above ear on head was new as well as the migraine not being from hormonal change as they were typical. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of shoulder pain, neck pain, migraine and ear pain were not resolved at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
38 2021-07-03 taste disorder, smell distorsion Head ache , tired , stomach ache , diarrhea, smell and taste
38 2021-07-06 vision blurred My throat was itchy, and I was coughing. Then, I had an anxiety attack. I stayed at the vaccination ... Read more
My throat was itchy, and I was coughing. Then, I had an anxiety attack. I stayed at the vaccination location for 40 minutes until I felt better. When I got home, the first and second day I felt tired and nauseated. Sunday, I felt normal and on Monday I woke with a migraine, very nauseated, really dizzy, had blurry vision, and I couldn't stand without holding onto the wall. Tuesday, I had the exact same side effects plus an itching/burning throat. I went to the ER on Tuesday, and everything was normal. CT scan was taken on Tuesday. I no longer have headaches, and I am no longer nauseated. Throughout the whole ordeal I had no energy. I can no longer tolerate the heat, I always get really hot.
38 2021-07-07 mouth swelling Called hospital callc center to report c/o swelling mouth, headache, body ache, weakness, severe anx... Read more
Called hospital callc center to report c/o swelling mouth, headache, body ache, weakness, severe anxiety. Advised pt to go to ED .
38 2021-07-08 taste impairment Mouth tasted like metal within 1 minute of receiving the vaccine, but I can still taste food. Scratc... Read more
Mouth tasted like metal within 1 minute of receiving the vaccine, but I can still taste food. Scratchy throat within 15 minutes of receiving the vaccines.
38 2021-07-12 lip swelling angioedema, began in my hands, feet and was mostly red/swelling in palm and arches started the nig... Read more
angioedema, began in my hands, feet and was mostly red/swelling in palm and arches started the night before dose 2 within a week it was occurring in my face and then started to get a few hives as well up and down my arms met with Dr. who diagnosed me with either acute or chronic idiopathic Urticaria and angioedema - then later after it hit 6 weeks of symptoms it became chronic. she said it will go away within 4 years. I do not think she feels it is related to the vaccine because it did not occur immediately. She has been working with me on symptom treatment with various antihistamines and other Rx and OTC to help manage it and improve quality of life. Currently take 20mg of Zyrtec and Pepcid each, am and pm, recently added Montekulast in pm which has finally made the hives stop breaking through on a daily basis, for now. I did get a cold over memorial day weekend and my face swelled up horribly along my lower lips and into my cheek as my body responded to fight it. She said that flare ups with viral infections or trauma to the skin can cause that with this condition. Had to change my nightly zyrtec to Hydroxyzine for two weeks to get back to normal. My concern is that the known condition might NOT be the case if it is related to the vaccine which we are still not sure we know much about. Also the fact that I have an auto immune disease could further complicate things
38 2021-07-14 pain in jaw Severe body aches and pain, fever, chest pain, jaw pain, back pain upon taking a breathe, Pain acros... Read more
Severe body aches and pain, fever, chest pain, jaw pain, back pain upon taking a breathe, Pain across shoulder blades and through arms
38 2021-07-15 loss of smell No unusual side effects. However, I have an autoimmune condition and am on immunosuppressants. My ... Read more
No unusual side effects. However, I have an autoimmune condition and am on immunosuppressants. My husband came down with COVID right before he was eligible for the vaccine so he brought it home in early April. We have 2 young kids under 5 so were unable to isolate from each other realistically in the home. I tested positive on 4/12 and had a very mild COVID illness compared with my husband, only had low grade temp 99-100, loss of smell with bloody sinus discharge, mild brief headache. However about 10-14 days later, I became very short of breath, had tachycardia to 115 just walking around my house (usually I'm pretty fit), chest pressure, palpitations. Talking for prolonged periods of time left me very winded. I lost time from work. About 3 weeks after initially test, I went to the ER and my EKG and lab tests were normal EXCEPT my D-dimer was elevated to 870 so I got a CT scan to rule out pulmonary embolism. My CT was normal, but CTs cannot see the microemboli (small clots) seen on autopsies of COVID patients.
38 2021-07-17 pain in jaw This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 17Mar2021 at 12:00, the patient was 9 days out and had a lot of shortness of breath, jaw pain, fatigue, night sweats and generally feeling not well. This was after a single dose and never had COVID. It was unknown if the patient received any treatment for the reported events. The adverse events resulted in emergency room/department or urgent care visit. The outcome of the events lot of shortness of breath, jaw pain, fatigue, night sweats and generally feeling not well were not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
38 2021-07-17 taste disorder Nausea; Fatigue; Chills; Diarrhoea; 6lb weight loss within 24 hours; Constant burping; Bloating; Foo... Read more
Nausea; Fatigue; Chills; Diarrhoea; 6lb weight loss within 24 hours; Constant burping; Bloating; Food taste bland; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8732) via an unspecified route of administration in the left arm on 28Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient had allergies to lisinopril and losartan. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) and liraglutide (SAXENDA) weight loss injection. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 29Mar2021 at 18:30, the patient experienced nausea, fatigue, chills, diarrhea for at least 24 hours, 6lb weight loss within 24 hours, loss of appetite, food taste bland that normally the patient find good, constant burping and bloating. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic treatment was taken for the reported events. The clinical outcome of the events diarrhea recovered on 30Mar2021. The clinical outcome of the events nausea, fatigue, chills, diarrhea, 6lb weight loss within 24 hours, loss of appetite, food taste bland that normally find good, constant burping and bloating were not resolved at the time of this report. No follow-up attempts are needed. No further information expected.
38 2021-07-17 ringing in ears This is a spontaneous report from a contactable consumer, the patient. A 38-years-old non-pregnant f... Read more
This is a spontaneous report from a contactable consumer, the patient. A 38-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203) via unspecified route of administration in the left arm on 30Mar2021 at 09:30 as a single dose for COVID-19 immunisation (at the age of 38-years-old). Medical history included meniere's disease. The patient reported no allergies to medications, food and other products. Concomitant medication was claritin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 30Mar2021 at 10:00 (30 minutes after), the patient experienced the shot she developed a loud ringing in her ears and sounds became amplified. 24 post vaccination there had not been any improvement. The tinnitus was very loud and the amplified noises are uncomfortable. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had not received treatment for event. The clinical outcome of event tinnitus was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
38 2021-07-18 oropharyngeal discomfort CLIENT STATES SHE WAS FEELING WARM, DIZZY, AT 10:45, STARTED TO SWEAT AND STATED THAT SHE HAD A 'FRO... Read more
CLIENT STATES SHE WAS FEELING WARM, DIZZY, AT 10:45, STARTED TO SWEAT AND STATED THAT SHE HAD A 'FROG IN HER THROAT' AND STARTED TO GASP. 10:47 0.15 MG OF BENEDRYL GIVEN IM IN R THIGH AND EMS WAS CALLED CLIENT SP O2 IS 88%, CLIENT REPORTS BEING NAUSEAOUS AND SHAKING THROWS UP SMALL AMOUNT OF FOAMY CLEAR FLUID. CLIENT SP 02 IS 98% EMS ON SITE, TAKES CLIENT TO ER VIA AMBULANCE. LEAVES CLINIC BY 11AM APPROXIMATELY CLIENT GOES TO ER
38 2021-07-18 swollen tongue Symptoms consistent with MCAS, ME/CFS, neuropathy, anxiety, panic attacks, anaphylaxis, swelling of ... Read more
Symptoms consistent with MCAS, ME/CFS, neuropathy, anxiety, panic attacks, anaphylaxis, swelling of throat and tongue, dysautonomia, heart palpitations, widespread inflammation and neuropathy especially at sites of old or previous injury. Cognitive issues consistent with brain fog and extreme confusion.
38 2021-07-18 vision blurred Blurry vision from first covid vaccine- 24 hours
38 2021-07-19 eye discomfort, vision blurred Chest pain, breathing problem, tingling and numbness in right fingers, (first 3 side effects lasted ... Read more
Chest pain, breathing problem, tingling and numbness in right fingers, (first 3 side effects lasted for 4 days) sore left arm, severe anxiety levels elevated, (lasted 5 days) fever up to 102.7 (for 3 days after injection), could not focus especially out of my right eye, pressure behind right eye and in chest. Overall side effects lasted about 5 days.
38 2021-07-22 swollen tongue she got a big hive on her body that started on her shoulders and popped up on different spots of her... Read more
she got a big hive on her body that started on her shoulders and popped up on different spots of her body; Some spots hurt more than others. I got it on my tongue and woke up with my tongue swollen; left ankle was hurting her and swollen/left shoulder was hurting really bad; left ankle was hurting her and swollen/swelled up again on her left shoulder; her whole throat was swollen, itchy; knee like on her bone, it's really hard; she took some Benadryl, thought it was an allergic reaction to the shot; her bone was hurting, her whole left arm was hurting to the core of her bone; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 10:30 (Batch/Lot Number: ER2613); dose 1 administered in Arm Left on 23Apr2021 (Batch/Lot Number: EW0172) as single dose for covid-19 immunisation at the age of 38-year-old. Medical history included ongoing hypertension from the summer of 2019 but she didn't really start taking any medication for it until the summer of 2020. Concomitant medication included losartan taken for hypertension from 2020 and ongoing. About three days after the second dose (also reported on 16May2021), she got a big hive on her body that started on her shoulders and popped up on different spots of her body. It went away after a week and then came back. She has had it for the last week and its coming up on different spots. It itches and it hurts. They were big bumps that are moving. They itch, their hot and they do hurt. Some spots hurt more than others. I got it on my tongue and woke up with my tongue swollen. I got one on my face, neck, back, shoulders, arms. I would say this is severe but I'm still breathing. Reporter stated she got the Pfizer vaccine and she got the first and second dose and about 3 days after she got the second dose, she got a big hive on her body. Reporter stated it started on her shoulders and kind of like spread, it popped up in different spots and stayed for about a week and then it went away so she wasn't worried. Reporter stated she took some Benadryl, thought it was an allergic reaction to the shot and then all of a sudden a month, almost 2 months now, came back and won't go away. Reporter stated she's had it about a week again, its been popping up in different spots since the shot, it's moved down her body and its really hard, it itches, it hurts in certain spots where it goes, then it moves and its not going away now. stated she knows its the shot because she's never been allergic to medicine in her life and never had a allergic reaction like this. Reporter stated she's assuming it went away. Reporter stated on her ankle, it had swollen up and she had a physical and the doctor checked her ankle and said it didn't look like anything was wrong, she didn't sprain it, she wasn't sure why it was hurting. Reporter stated they did an x-ray and everything was fine, it didn't show any problems with ligaments or bones. Reporter stated she doesn't know if it settled there for a while, her left ankle was hurting her and swollen, she doesn't know why it was swollen. Reporter stated she had that for about 2 weeks, actually it still comes and goes, but its gone right now, actually it was more than 2 weeks. Reporter stated these hives haven't been completely gone, they weren't as much. Reporter stated like right now its all over her body, all over her back, the back of her legs, its like right under the skin and it still gets in the muscle or something, the knee like on her bone, its hard in one spot. Reporter stated it just keeps moving spots in her body and its so weird because on her left ankle it was really sore and hurting her and then it went up to her left shoulder and her left shoulder was hurting her for a while but she didn't have a bump, and then all of a sudden the left shoulder was hurting her really bad, every night she couldn't sleep on it. Reporter stated all of a sudden she swelled up again on her left shoulder. Reporter stated it looks like there's a baseball in her shoulder. Reporter stated at first she thought it was a bug bite, but bug bites don't move. Reporter stated it started small, like a small bump and it got bigger and bigger and bigger at least 2 inches wide, like a deformed circle, not even a regular circle and it got really big on her shoulder, so big that it looked like there was a baseball in her shoulder. Reporter stated it was really red, really hard, really hot, super hard, and itchy and then it moved. Reporter stated this pain, its so weird, this pain on her left shoulder, she's a little worried about it and then she took some pain killers and so one night when all these bumps started coming back, her left shoulder it was hurting her so bad, her whole bone, her whole left arm was hurting to the core of her bone. Reporter stated her hands and palms got swollen and it hurt so bad she was crying. Reporter stated they were not home, so she didn't want to go to the doctors over there. Reporter stated she doesn't want to go to the doctor because she's scared they are going to keep her in a room for observation and not let her out because they don't know what the hell to do so that's the only reason she hasn't gone to the doctor. Reporter stated another night she woke up and her esophagus, or the little thing in the back of her throat, that thing was swollen, her whole throat was swollen and itchy and that went away in 24 hours. Reporter stated she keeps swelling up in different spots in her body and then it moves. Reporter stated her arm, its one spot in her arm, its really hard. Reporter stated when it got into her palms, it got really red looked like bruises then went away. Reporter stated now, it's all over her back now, all kinds of bumps, all over her back from one side to the other. Reporter stated this is really freaking her out. Reporter stated and right now its behind her knees, so it never really has gone away, it's just gone in different spots. Reporter stated it wasn't as bad, then all of a sudden, its all over her body so it never really went away. Reporter stated it's like everyday its getting worse. Reporter stated she's got bumps all over the back of her neck that's going up into her scalp now. Reporter stated if she saw them, she would think they were hives. Reporter stated all her symptoms began in May after she got the COVID shot and then after the COVID shot, they stayed for a little while then they spread through her body in a whole week then moved in all different parts of her body, her inner thighs, ankle, right shoulder, then it kind of went away in her body, but she still felt pain on right shoulder on the inside and her left ankle was swollen then all of a sudden it popped up all over body again. Reporter stated it started happening in the last week and its crazy, its all over. Reporter stated she thought it was gone, but now that it came back, she knows that pain in her right shoulder was from it, she means her left shoulder. Reporter stated it doesn't pain her anymore but like she said her whole arm got swollen, her palms got swollen and it moved from that spot. Reporter stated and she knows she got the x-ray after she got the shot because she had a physical and the doctor wanted to update other shots, ones she gets as she gets older and the caller told the doctor that she's getting these bumps, its really weird, she's not sure where they are from, and so the doctor didn't give her any shots and told her she was having a reaction from the Pfizer. Reporter stated the doctor didn't say she knew what to do or anything. Reporter stated all the big bumps she's getting again had went away so she wasn't concerned anymore because she thought the reaction was already done but really it wasn't because that's why her left shoulder is hurting her and ankle is bothering her and she knows its from the shot because the bump on the ankle went away and she didn't even do anything to her ankle , she didn't twist it or anything and the same thing happened to her left shoulder. Reporter stated all the bumps are really freaking her out because they aren't going away, but now they are all over her body again. The patient underwent lab tests and procedures which included x-ray: didn't show any problems in May2021. The outcome of the events was unknown. The patient didn't visit Emergency Room or Physician Office. Follow-up attempts are completed. No further information is expected.
38 2021-07-23 loss of taste, loss of smell Coughing, Wheezing, Fever, No taste , No smell, hurting all over
38 2021-07-23 feeling of choking Patient stated that her throat felt tingly . She said she thought she was having the same reaction a... Read more
Patient stated that her throat felt tingly . She said she thought she was having the same reaction as a previous patient. She was given 25 mg of Benadryl and symptoms resolved.
38 2021-07-24 hearing loss Next morning after getting a shot around 4am my head shook for a few seconds and stopped. And then a... Read more
Next morning after getting a shot around 4am my head shook for a few seconds and stopped. And then about 4 days later I noticed a slight change of my hearing on my right ear. Went to get it checked and even had MRI done and no explanation. Only event that took place is the shot.
38 2021-07-24 eye discomfort pt c/o pressure behind her eyes and slightly light headed. Pt consumed one bottle of water. Pt repor... Read more
pt c/o pressure behind her eyes and slightly light headed. Pt consumed one bottle of water. Pt reported not having anything to eat since noon. Pt asked by EMS if she had checked her BS, pt stated, "No she had not". Pt encouraged to stay with AC blowing on her and to dringk some more water. Pt unerstood. No S/S of respiratory distress noted, no swelling at injection site. pt denied itching or difficult breathing or swallowing. Pt verbalized understanding. Pt stated, "I feel better". Pt left site at 1907
38 2021-07-25 lacrimation increased a 38 years old female received her first dose of pfizer #lot: EW0180 in 07/02/2021. She refer that ... Read more
a 38 years old female received her first dose of pfizer #lot: EW0180 in 07/02/2021. She refer that in the next sunday (july 4,2021) her eye star to tearing. In the next day (july,5,2021) patient noted an inflammation in her left eye. Patient said that her eye left eye have the appearance of a burn. Patient call her dermatologist but he never respond. She take panadol and eye drops.
38 2021-07-25 lip swelling Starting in June , started to get intense hives almost every other day and/or swelling of the lip. W... Read more
Starting in June , started to get intense hives almost every other day and/or swelling of the lip. Was prescribed an antihistamine as well as an epipen.
38 2021-07-25 mouth tingling, tongue disorder My tongue felt fat, tingly, and fuzzy. My throat felt tight and my cheeks were red and tingly. That ... Read more
My tongue felt fat, tingly, and fuzzy. My throat felt tight and my cheeks were red and tingly. That occurred at the pharmacy and I was extremely dizzy when I arrived home. I had to lay down to let it pass. The pharmacy gave me Benadryl and I took an additional Benadryl when I got home and four hours later.
38 2021-07-27 loss of smell, loss of taste Immunized on 4/2/21 and 4/23/21. sinus pressure, loss of taste and smell since 7/26/21. Covid test ... Read more
Immunized on 4/2/21 and 4/23/21. sinus pressure, loss of taste and smell since 7/26/21. Covid test positive on 7/27/21
38 2021-07-27 swelling of eyelid swollen and red eyelids; swollen and red eyelids; Sneezing (~60 + times); pain from lymph node in le... Read more
swollen and red eyelids; swollen and red eyelids; Sneezing (~60 + times); pain from lymph node in left armpit; dizziness; lump in throat; Felt hungover; nausea; splitting headache; lethargic; Foggy head; injection site pain; chills; fever; muscle aches; sensitive to any touch (lightly touching my skin felt like needles and washing my hair hurt my scalp).; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9266 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 12:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included eczema and food allergy (Hazel nuts and nuts). Concomitant medications included ascorbic acid, folic acid, iron, vitamin b12 nos (VITA GUMMYS IRON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Foggy head, injection site pain, chills, fever, muscle aches, sensitive to any touch (lightly touching my skin felt like needles and washing my hair hurt my scalp) on 05Mar2021 at 03:30 PM, Felt hungover, nausea, splitting headache, lethargic on 06Mar2021, Sneezing (60 + times), pain from lymph node in left armpit, dizziness, lump in throat on 07Mar2021 and swollen and red eyelids, dizzy on 08Mar2021. Outcome of all the events were recovering. No follow-up attempts are possible. No further information is expected.
38 2021-07-27 taste disorder, loss of smell I had a drink of coffee and asked my husband if he brunt it because it tasted odd, then since then m... Read more
I had a drink of coffee and asked my husband if he brunt it because it tasted odd, then since then my taste on several food and drink items has changed. It's a gross taste in my mouth upon smell the item and even while eating.; I can't really smell bleach, my toothpaste (2 different brands) and other food all taste/smell the same.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ew0150), via an unspecified route of administration in the left arm on 07Apr2021 at 18:30 (at the age of 38-years-old) as single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medication taken within two weeks included ethinylestradiol; norgestimate (SPRINTEC) from an unknown date for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 11Apr2021 at 08:00, the patient experienced taste change and smell loss. The patient had a drink of coffee and asked her husband if he had brunt it because it tasted odd, then since then her taste on several food and drink items had changed. It was gross taste in her mouth upon smell the item and even while eating. There were several things the patient just couldn't eat because it was gross but she used to highly enjoy them. The patient couldn't really smell bleach, her toothpaste (2 different brands) and other food all tasted/smelled the same. The clinical outcome of the event taste change and smell change was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ew0179), via an unspecified route of administration in the left arm on 28Apr2021 at 18:30 (at the age of 38-years-old) as single dose for COVID-19 immunisation and the adverse events for the second dose were not reported. No follow-up attempts are needed. No further information is expected.
38 2021-07-28 loss of taste, loss of smell no smell; headache; cough; no taste; congestion; I tested positive for corvid 19 and have mild sympt... Read more
no smell; headache; cough; no taste; congestion; I tested positive for corvid 19 and have mild symptoms congestion, headache, cough, no taste or smell.; 1st dose taken on 05Feb2021 and the 2nd dose was taken on 15Jun2021; 1st dose taken on 05Feb2021 and the 2nd dose was taken on 15Jun2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3247 and Expiry date was not reported), dose 2 via an unspecified route of administration in arm right on 15Jun2021 13:00 (age at vaccination was 38-year-old) and dose 1 (Lot Number: EL3247 and Expiry date was not reported) via an unspecified route of administration in arm right on 05Feb2021 13:00 as a single dose for covid-19 immunisation. Medical history included drug hypersensitivity (Sulfur base drugs) from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient tested for COVID-19. Concomitant medications received within 2 weeks of vaccination included birth control pills, OTC, cetirizine hydrochloride (WAL ZYR) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Jul2021 at 03:00 tested positive for corvid 19 and have mild symptoms congestion, headache, cough, no taste or smell. Due to the events patient visit Doctor or other healthcare professional office/clinic visit. Treatment received for the events was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test post vaccination: negative on 19May2021, negative on 25Jun2021, positive on 15Jul2021 by using nasal swab and covid test name was SARS-CoV-2 (APTIMA). The outcome of the events was unknown.
38 2021-07-28 eye floaters, sensitivity to light, vision blurred, double vision, visual field defect, visual impairment About 2 weeks after my first shot, I started to have intense shoulder pain followed by a numb hand a... Read more
About 2 weeks after my first shot, I started to have intense shoulder pain followed by a numb hand a couple of days later. The next day, my vision was weird, and the day after that I had dizziness, nausea, lack of balance, sensitivity to light, vertigo, a tingling sensation in my head, and a range of vision changes (hallucinations, lack of depth perception, blurriness, double vision, trouble focusing, two-dimensional objects looking three-dimensional, narrow field of vision). All of these symptoms were relatively constant and lasted from 4/19-5/6. Then they all went away. On May 21 I got my second shot, and about 6 hours later I had some of the same 3D vision changes, which only lasted that night. Then on June 10th I had a range of vision changes (hallucinations, seeing lights when I close my eyes, seeing lots of floaters, static quality to vision in dim light). I also had dizziness, vertigo, and nausea on and off. These symptoms continued until July 20th. I now am mostly better, but I still have a few lingering vision issues.
39 2021-01-01 pupils dilated Covid Pfizer vaccine dose one on 12/21/20 - at 18 minutes post vaccination, globus sensation, diapho... Read more
Covid Pfizer vaccine dose one on 12/21/20 - at 18 minutes post vaccination, globus sensation, diaphoresis, neuropathic crawling all over scalp, loss of consciousness, heart rate 35 bradycardia event. Responders said I was out for a minute or so then regained consciousness. Pupil dilation during event per responders. ICU MD responder states no radial pulse but had carotid pulse which was weak at initial loss of consciousness. Given fluids. Blood pressure normal during fluids. Improved heart rate without tachycardia. Had recurrence of clammy hands, globus sensation with frequent swallowing/throat clearing about 30 minutes after initial event while still receiving fluids. No airway compromise or stridor. Received PO Benadryl 25 mg. Transferred to ER for monitoring for an additional 90 minutes with complete resolution of globus sensation about 30 minutes after Benadryl. Fatigue and weak post event.
39 2021-01-03 loss of taste, loss of smell Vaccinated at mass vaccination event for nursing home staff and residents on 12/18/2020. Developed c... Read more
Vaccinated at mass vaccination event for nursing home staff and residents on 12/18/2020. Developed cough, runny nose, sore throat, loss of taste and smell and tested positive for COVID-19 on 12/24/2020. Had exposure to COVID+ mother whom she takes care of.
39 2021-01-03 dry mouth, drooling 2 hrs post injection sudden onset of severe dry mouth that lingered but gradually resolved. Still dr... Read more
2 hrs post injection sudden onset of severe dry mouth that lingered but gradually resolved. Still dry next morning and a couple hrs later it switched to increased salivation. The evening after injection I had a headache and just felt general malaise and fatigue, "run down". Difficulty sleeping that night due to body aches. HEadache, neck and lower back pain. Skin sensitivity when touched, bed sheets kinda hurt my skin. The bodyaches and malaise persisted through out day 2. Tylenol seemed to help. I slept better that night but woke up with night sweats, completely drenched. Arm pain at injection site on day 2 that resolved by mid day. Now 1 week later I have extreme fatigue yesterday and today. I do have hypersomnia but not even my adderall is helping. Not sure if this is related or not.
39 2021-01-03 mouth tingling, mouth numbness I got the vaccine in my right arm. About 30 min after the vaccine, I started feeling numbness/tingli... Read more
I got the vaccine in my right arm. About 30 min after the vaccine, I started feeling numbness/tingling in my right jaw/mandible area that spread behind my ear. Over about an hour or 2 I could feel the numbness/tingling/strange sensation move across the top of my right lip and into my right nostril. I took benadryl and it seemed to stop the spreading but the strange sensation stayed on the right side of my face for about 4 days afterwards.
39 2021-01-04 loss of smell, inability to speak result back w positive covid; positive COVID-19 test with symptoms; This is a spontaneous report fro... Read more
result back w positive covid; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse reporting for herself. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Dec2020 11:00 (at age 39 years old) as a single dose (Dose 1) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient was not administered any other vaccine in the 4 weeks prior to COVID-19 vaccination. Medical history was none. There were no allergies to medication, food, or other products. The patient's concomitant medications were not reported; however the patient had not received any other medications in the last 2 weeks. The patient experienced a sore throat, voice loss on day 4, loss of smell on day 5, went to test, and the result came back with positive COVID. The events resulted in a Doctor's office visit. The patient was tested post vaccination on 22Dec2020 via NAAT-PCR (nasal swab), with a positive result. The patient had not been diagnosed with COVID-19 prior to vaccination. There was no treatment received for the event(s). The clinical outcome of the event positive COVID was unknown The event was reported as non-serious. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The association between the event drug ineffective (COVID-19 infection) with BNT162b2 can not be fully excluded.
39 2021-01-04 ear infection Administration of vaccine was given about 3 inches too low, not sure if it went into muscle or subcu... Read more
Administration of vaccine was given about 3 inches too low, not sure if it went into muscle or subcutaneous but I did end up with an injection site reaction 2 days later to include a 2x3 inch red, itchy, raised, hot to the touch welt. Also had extreme dizziness, nausea, headache 2 days after injection. Dizziness, nausea, headache subsided after 24hrs however injection site reaction will go away and come back randomly. Seems to coincide with getting sick? Was fine up until 12/29 when I did end up getting sick to include headache, body aches, chills. I went to go get covid tested which was negative. I ultimately had a sinus/ear infection. However injection site reaction had gone away UNTIL I got sick on 12/29 then it showed up again and still have it as of today.
39 2021-01-04 eye irritation burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had ho... Read more
burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had hot flashes; skin pain; joint pains; numbness of the whole arm; site pain; Headaches; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 39-years-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EJ1685, Expiration Date: 31Mar2021), via an unspecified route of administration in left arm on 28Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included obesity, asthma, hypothyroidism, vitamin D deficiency, multiple tendonitis, allergies to horses, cats, and dogs and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included mometasone furoate (ASMANEX), colecalciferol (VITAMIN D), levothyroxine sodium (SYNTHROID) and hydroxychloroquine, all received within 2 weeks of vaccination. The patient stated for hours post injection she had hot flashes but the worst was 12hrs after. She experienced severe muscle pain/ skin pain, joint pains, burning of eyes, Headaches, low grade fever, site pain, numbness of the whole arm, hot flashes followed by rigors. The events started on 28Dec2020 21:00. Treatment received for the events included Tylenol. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.
39 2021-01-04 mouth numbness, lip swelling Slight numbness and swelling left side of upper lip half an hour after first injection. Patient obs... Read more
Slight numbness and swelling left side of upper lip half an hour after first injection. Patient observed for an additional 45 minutes after symptoms. Symptoms did not progress. Patient advised to continue to monitor symptoms and if swelling or numbness progress to seek medical attention immediately. Patient returned to work.
39 2021-01-05 ear pain extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left ar... Read more
extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left arm and up to behind left ear; pain radiating down left arm and up to behind left ear; neck tightness; mild headache; This is a spontaneous report from a non-contactable Nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 29Dec2020 10:30 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroid, PCOS (polycystic ovarian syndrome), sulfa allergies. Concomitant medications included unknown medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 29Dec2020 13:00, the patient experienced extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild headache. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild head ache was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
39 2021-01-05 eye itchiness PERIORBITAL AND SCALP ITCHING
39 2021-01-05 swelling around the eyes Puffy eyes. Right more than left; This is a spontaneous report from a contactable other-HCP. This 39... Read more
Puffy eyes. Right more than left; This is a spontaneous report from a contactable other-HCP. This 39-year-old female other-HCP (patient) reported for herself that she received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscularly at left arm at single dose for COVID-19 immunization on 30Dec2020 02:00 PM. Relevant medical history was none. Relevant concomitant drug was unknown. The patient experienced puffy eyes, right more than left on 30Dec2020. The event was assessed as non-serious. No treatment was received for the event. Outcome of event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
39 2021-01-05 swollen tongue Patient woke on 1/01/2021 with headache; swelling of left-side of neck; swelling of tongue
39 2021-01-05 ringing in ears My ear started to ring; My blood pressure was kind of up; Lot of anxiety; This is a spontaneous repo... Read more
My ear started to ring; My blood pressure was kind of up; Lot of anxiety; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included neuropathy. Concomitant medication included pregabalin (LYRICA) for neuropathy. The patient experienced side effects on 30Dec2020: she had the injection on 30Dec2020 and then about five minutes after like she just walked to sit down, her ear started to ring pretty significantly just like ring in both ears and she spoke with the medical professional there, the nurse was like to see her blood pressure and she did, her blood pressure was kind of up and the ear ring had continued. It never stopped. It got better. She was kind of had a lot of anxiety around this. The outcome of event ear started to ring was resolving, outcome of other events was unknown.
39 2021-01-05 tongue itchiness 15 to 30 minutes after vaccination experienced itchy throat and tongue and dizziness
39 2021-01-06 mouth numbness Perioral numbness & mild edema.
39 2021-01-06 pain in jaw, swollen tongue, eye swelling Felt sharp pain under jaw, then facial numbness. Then quickly developed facial swelling, left eye sw... Read more
Felt sharp pain under jaw, then facial numbness. Then quickly developed facial swelling, left eye swelling and tongue swelling. Then felt like throat closing up within 7 minutes of receiving vaccine. Received vaccine in the clinic, was transported to Emergency Room. In ER received Epinephrine, steroids, Benadryl and Pepcid.
39 2021-01-06 sensitivity to light site soreness (started within 3 hours of injection and is still sore 2 days later) , sleep disturban... Read more
site soreness (started within 3 hours of injection and is still sore 2 days later) , sleep disturbance night of injection, elevated temp of 100deg (started at 0200 on the 6th and lasted for 24 hours), whole body aches esp neck and back pain (Started when temp started and has lasted after temp has stopped for a total of 31 hours). Migraine with sensitivity to light (started at 0400 on the 6th and lasted for 5 hours). Nausea and heartburn (started on the 6th at 1845 lasting 5 hours despite taking famotidine)
39 2021-01-06 thirst Woke up at 3am with the chills took my temp was 99.8. Took my morning medicines and then some ibupr... Read more
Woke up at 3am with the chills took my temp was 99.8. Took my morning medicines and then some ibuprofen, was having body aches and severe chills. Went back to bed and took my temp an hour later was 101.0. Had body aches, chills, thirst, weakness, headache for the rest of the day. Temperature went from 99.0 to the highest of 102.0. Got ahold of covid 19 hotline at work, they said it was a reaction to the shot and should be gone within 72hrs. If not then I would need to get covid tested. Got ahold of my pcp and they ordered a covid test but I told them what the hotline had said and that I would wait to get one done. It has been 24 hour since and now I no longer have a fever and am feeling better just tired.
39 2021-01-07 taste impairment Headache upset stomach, metallic taste, loose stool Narrative:
39 2021-01-07 eye swelling Itchiness to multiple sites followed by rash and swollen eyes. Saw PCP placed on steroid course x 7... Read more
Itchiness to multiple sites followed by rash and swollen eyes. Saw PCP placed on steroid course x 7 days plus antihistamines.
39 2021-01-07 mouth numbness Patient received her vaccination on Monday, 1/4/21. She waited her 15 minutes of observation and the... Read more
Patient received her vaccination on Monday, 1/4/21. She waited her 15 minutes of observation and then left. She states on her way home she started feeling that her tongue and left side of her face was a little bit numb. It continues to be numb and on examination the left side of her face has diminished sensation. Her left eye is droopy and she has a symmetrical eyebrow raises as well as smile. Her diagnosis is consistent with possible Bell's palsy.
39 2021-01-07 mouth numbness UrticariaPruritus Reported lip numbness c/ injection, reported to monitor no action. Employee left a... Read more
UrticariaPruritus Reported lip numbness c/ injection, reported to monitor no action. Employee left and called staff and reported hives on upper and lower lips, lips warm to touch Narrative: Reported lip numbness c/ injection, reported to monitor no action taken. Employee left after 15mins. Employee reported hives on upper and lower lips, lips warm to touch ( text message) no action taken
39 2021-01-07 lip swelling Had itchy hives on face and neck, some lip swelling, dizziness; Denied SOB or throat tightness. Pfi... Read more
Had itchy hives on face and neck, some lip swelling, dizziness; Denied SOB or throat tightness. Pfizer vaccine was given at 11:45 AM and reaction onset at 11:55. VS at 12:10: BP 132/67; HR: 100; O2 96%; Epi given at 12:22; Was taken to ED for observation. Patient has PMHx of RA and Asthma; Meds include Methotrexate, Advair, Omeprazole, Vit D; Allergies to PCN and Percocet; Had anaphylactic reaction to sucralose for fit test.
39 2021-01-07 feeling of choking Tickle in throat / throat itching, Can't get a full swallow, anxious, jittery
39 2021-01-07 taste disorder, mouth tingling About 3 minutes after I received the vaccine I became flushed for just a few moments and had a stran... Read more
About 3 minutes after I received the vaccine I became flushed for just a few moments and had a strange taste in my mouth. I could feel a tingle in my mouth at the same time. I became panicked of course but the flushing quickly subsided. The mouth sensation lasted a bit longer but there was no airway compromise at all.
39 2021-01-07 ringing in ears, deafness, permanent deafness 4 days after receiving vaccine, was awoken from sleep with high pitched tinnitus in right ear. I di... Read more
4 days after receiving vaccine, was awoken from sleep with high pitched tinnitus in right ear. I discovered in the morning that i could not hear out of that ear. My husband, a physician, examined ears and did not see any effusion. Consulted with a friend who is an ENT specialist, and he recommend initiating high dose steroids immediately. 2 days later, had audiology test in ENT office, and it revealed severe Sensiorneural hearing loss in right ear. The steroids were continued, and valtrex was added. I had MRI of head on 1/7/20 which did not reveal any abnormality.
39 2021-01-07 ringing in ears, mouth numbness Elevated blood pressure (155/95); decrease in heart rate (55); Face & tongue went numb; Face & tongu... Read more
Elevated blood pressure (155/95); decrease in heart rate (55); Face & tongue went numb; Face & tongue went numb; Residual ringing in left ear; This is a spontaneous report from a contactable physician, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 22Dec2020 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included seasonal allergies and allergies/asthma, from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 22Dec2020 at 16:00, the patient experienced elevated blood pressure of 155/95 (normal was 110/60), a decrease in heart rate which was 55, face and tongue went numb and residual ringing in the left ear. The patient was treated for the events with diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events elevated blood pressure of 155/95 (normal was 110/60), a decrease in heart rate which was 55, face and tongue went numb and residual ringing in the left ear was resolved with sequel. Information on lot/batch number has been requested.
39 2021-01-08 ear pain I have had the "normal" reactions such as; sore arm, ear and throat pain, headache, fatigue, and bod... Read more
I have had the "normal" reactions such as; sore arm, ear and throat pain, headache, fatigue, and body aches. I have also noticed my neck hurting and this am I notice a knot like form on my left clavicle bone that was not there prior to the the vaccine. I have not had any treatment for this.
39 2021-01-08 mouth tingling, mouth numbness numbness and tingling in left side of face (1/8), also in tongue and right hand (1/9)
39 2021-01-08 light flashes or floaters in the eye About 3-5 minutes after I felt so out of it. I felt like I was under the influence of something. I... Read more
About 3-5 minutes after I felt so out of it. I felt like I was under the influence of something. I tried to read my email and the words were there but didn't have meaning. I had to drive home after my 15 minute observation and plugged my home address into my gps so I wouldn't get lost even though I drove home from Medical Center for years. I got home and laid down and slept for a couple hours and woke up fine. I felt ok the following day and was doing laundry around 6 pm and my arm stopped being sore and I got really dizzy and nauseated and my vision had shadows (reminded me of an ocular migraine) and drank 2 x 16 oz glasses of water and laid down and felt better in about 20-30 minutes.
39 2021-01-08 visual impairment Reported feeling onset of dizziness, right side of eye vision change, flushed, and clammy about 7 mi... Read more
Reported feeling onset of dizziness, right side of eye vision change, flushed, and clammy about 7 minutes after dose #2 of vaccination. No hx of adverse vaccine response. Only seasonal allergies. High-risk pregnancy at 25 weeks. Hx of feeling dizzy when she gets up suddenly, otherwise, no other medical issues. V/S taken over 45 minutes with noted decrease in BPs which was not normal for her. Apple juice x3 given at increments of 15 minutes and finished 1 bottle of water. Reports feeling better and then s/s returned. States she feels tired during episodes and back to normal. Advised to be evaluated in ED since her drive was more than 55 minutes away from hospital. Agreeable and was transported to ED for observation. B/P: 9:51 110/58, 10:09 92/58, 10:25 91/49 HR: 9:49 63, 9:59 80, 10:09 80, 10:25 80 SpO2: 9:49 99, 09:59 99, 10:09 99, 10:25 97 No other interventions given. Wheeled to the ED, room 505 at 10:41. Report given to RN.
39 2021-01-09 taste impairment Severe Headache, body aches, chills, fatigue, and metallic taste in mouth
39 2021-01-09 oropharyngeal discomfort 15 minutes post injection, I was tachycardic, lightheaded, nearly fell over (nurse caught me as I st... Read more
15 minutes post injection, I was tachycardic, lightheaded, nearly fell over (nurse caught me as I started to sway), and my throat felt thick like something was stuck in it. Staff sat me into a recliner and called an ICU attending. Benedryl IM was given. Throat symptoms did not get worse but did take about 10-12 hours to resolve.
39 2021-01-10 ear infection, pain in jaw, hearing loss, ear pain Ear infection-Right ear Diagnosed 12/30 (treated with 10 day course of Augmentin), pain in ear and ... Read more
Ear infection-Right ear Diagnosed 12/30 (treated with 10 day course of Augmentin), pain in ear and jaw continue despite antibiotics, jaw pain, ear fullness, with decreased hearing.
39 2021-01-10 eye pain, pain in jaw 10 minutes later, minor headache and itching. 4 hours later, lightheadedness/dizziness. ~12 hours la... Read more
10 minutes later, minor headache and itching. 4 hours later, lightheadedness/dizziness. ~12 hours later (03:30 the next day) fever up to 102, skin felt on fire all over my body, gi cramps, mild intermittent cough, myalgias, fatigue, extreme headache behind my eyes, occiput, and jaw pain, rigors.
39 2021-01-10 lacrimation increased, swollen tongue Redness and itchiness to chest and lower neck around nose as well as minor tongue swelling. I was va... Read more
Redness and itchiness to chest and lower neck around nose as well as minor tongue swelling. I was vaccinated at 0710, waited my 15 minutes drove home ( 15 min) showered and then just before 9 am realized Inwas itchy. Checked chest area and had red blotches similar in pattern to an anaphylactic reaction I had a few years earlier to betadine exposure. The night of the vaccine Inwoke up with nasal congestion and rhinorhea, itchy ears and throat, watery eyes. This became worse throughout the following day where I continued benadryl 50mg q6 as well as alternating tylenol and ibuprofen for body aches
39 2021-01-10 pain in jaw Fever of 102, chills, rigors, myalgias, severe headache behind my eyes, occiput and jaw, intermitten... Read more
Fever of 102, chills, rigors, myalgias, severe headache behind my eyes, occiput and jaw, intermittent cough and gi cramping, along with feeling like my skin was on fire, especially on my face
39 2021-01-10 mouth tingling, mouth numbness My tongue became tingley, numb. My heart started to race and I became dizzy. The numbness has affe... Read more
My tongue became tingley, numb. My heart started to race and I became dizzy. The numbness has affected the right side of face and throat.
39 2021-01-10 mouth tingling Client reports with in minuets of being in the observation room her tongue started to tingle. Approa... Read more
Client reports with in minuets of being in the observation room her tongue started to tingle. Approached staff in hall and client and nurse went in to an exam room. Nurse started taking vitals and called Nurse Director and was instructed to administer 25ml IM of Diphenhydramine to right arm. Nurse cont. with taking vitals signs until client reported to feeling better.
39 2021-01-10 mouth tingling Client approached a Nurse in the hall, reports within min. of being in the observation room client r... Read more
Client approached a Nurse in the hall, reports within min. of being in the observation room client reports a "tingling tongue". Client was lead to an exam room and vitals were taken at 12:44pm. Lead Nurse called Nursing Director and was instructed to administer IM 25ml of Diphenhydramine to right arm. Vitals were continued every 5 min. Client reported "feeling better" and after aprox. 30min left to go home.
39 2021-01-10 swelling around the eyes developed UTI very quickly; Puffy face and eyes; Puffy face and eyes; Burning inside digestive tract... Read more
developed UTI very quickly; Puffy face and eyes; Puffy face and eyes; Burning inside digestive tract; Diarrhea; Dehydrated; arm pain; Headache; At bedtime neck stiffness began and worsened; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246/expiration date unknown), dose number 1, via an unspecified route of administration on 02Jan2021 10:30 at a single dose on the left arm for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications included alprazolam (XANAX). The patient experienced arm pain and headache 4 hours post injection requiring Excedrin. At bedtime, neck stiffness began and worsened. She was treated with lidocaine patches and Aleve. She developed diarrhea 33 hours post injection. She went ER because she was dehydrated. She developed UTI very quickly by hour 35 post injection. She had puffy face and eyes, and burning inside her digestive tract. She was treated with Benedryl at home for allergic reaction, Toradol for pain, IV fluids for dehydration and Keflex for infection. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 since vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Dehydration cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-10 swollen tongue Pfizer COVID-19 Vaccine EUA Patient experienced swelling of the tongue around 7 hrs after vaccinati... Read more
Pfizer COVID-19 Vaccine EUA Patient experienced swelling of the tongue around 7 hrs after vaccination. Patient took oral prednisone and swelling resolved.
39 2021-01-11 eye pain, ear pain, pain in jaw The numbness began to intensify and I could not feel myself blinking or smiling on the left side of ... Read more
The numbness began to intensify and I could not feel myself blinking or smiling on the left side of my face; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; This is a spontaneous report from a contactable nurse reported for herself. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142) via an unspecified route of administration on 07Jan2021 07:00 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was Workplace Clinic. Medical history included food allergy at shrimp. Concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 07:15 AM the patient notice pain and numbness to her left ear and left jaw that began to spread down left jaw and upward across left cheek, left eye, and left temple, and above left eyebrow. The numbness began to intensify and patient could not feel herself blinking or smiling on the left side of my face. The numbness slowly began improving over the next hour in the same order that it began, but she still have mild left ear and jaw pain and mild numbness. Events outcome are recovering. No treatment was received. The action taken was not applicable.; Sender's Comments: Based on the compatible time association, the facial palsy is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-11 eye itchiness Pt. started having tachycardia immediately after vaccination and hives developed two hour after vacc... Read more
Pt. started having tachycardia immediately after vaccination and hives developed two hour after vaccination was given. Pt. took propanolol for tachycardia(already prescribed this medication by pcp) and bendryl for hives along with cold water. Pt. still experiencing hives today and just took loratadine and zaditor eye drops for crusty/itching eyes.
39 2021-01-11 lip swelling 1/11/21 at 0625 recieved vaccine. Had taken benadryl to help sleep due to working night shift. Wok... Read more
1/11/21 at 0625 recieved vaccine. Had taken benadryl to help sleep due to working night shift. Woke up at 2:30pm and noticed swelling to face and inside of inner cheeks. Went to Free Standing ER and recieved Hydroxyzine to help reduce swelling and sent home. 1/12/21 this am noticed the swelling in cheeks was better but now has swollen necks glands and facial swelling is slightly better in cheek better, but lips and rest of face of face still swollen.
39 2021-01-11 mouth tingling dizziness, lightheadedness, tongue tingling
39 2021-01-11 mouth tingling Received IM injection, 5 minutes later she felt tingling down her left arm. Over the course of the ... Read more
Received IM injection, 5 minutes later she felt tingling down her left arm. Over the course of the afternoon it spread to her left jaw, neck, face and lips. She proceeded to be seen by UC. She took tylenol. She improved. She had nausea and seats as well. This is similar to the symptoms she had of covid the month previous.
39 2021-01-11 thirst Shaking from chills and fever, extreme thirst followed by vomiting, moderate headache, body ache, ki... Read more
Shaking from chills and fever, extreme thirst followed by vomiting, moderate headache, body ache, kidney area pain. Fatigue following. Missed work the following day.
39 2021-01-11 vision blurred Client c/o having blurry vision and splitting headache. Also felt very hot. Loss of consciousness.... Read more
Client c/o having blurry vision and splitting headache. Also felt very hot. Loss of consciousness. Able to respond to verbal commands.
39 2021-01-12 eye twitching 11 hours after vaccine, chills started. Fever, chills, severe headache and body aches, and fatigue ... Read more
11 hours after vaccine, chills started. Fever, chills, severe headache and body aches, and fatigue over next 24 hours. Bedridden, would not have been able to work or care for my children. Left eyelid began twitching at that time and has continued to have intermittent periods of twitching over the 5 days since.
39 2021-01-12 mouth numbness Patient developed numbness in her lips, had some tachycardia, and dizziness around 5:30 pm. Patient ... Read more
Patient developed numbness in her lips, had some tachycardia, and dizziness around 5:30 pm. Patient then notified one of the physician who advised her to monitor symptoms and notify on call provider if symptoms worsened. Patient then went home and slept and the next morning was feeling better.
39 2021-01-12 lip swelling, mouth tingling at 7:30 pm Itching on arms and burning sensation on all over back with some swelling and tingling on... Read more
at 7:30 pm Itching on arms and burning sensation on all over back with some swelling and tingling on left top lip.. Took benadryl didnt subside then took 60 mg prednisone and it subsided.
39 2021-01-12 lip swelling upper right lip swelling; hive on forearm above elbow on left arm; This is a spontaneous report from... Read more
upper right lip swelling; hive on forearm above elbow on left arm; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular in the left arm on 05Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history included type 2 diabetes. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included metformin and glucosamine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 06Jan2021 17:00, the patient experienced hive on forearm above elbow on left arm then on 07Jan2021, the patient experienced upper right lip swelling. No treatment was received for the adverse events. Outcome of the events was unknown. The events were considered non-serious by the reporter.
39 2021-01-12 mouth tingling, swelling of eyelid, mouth numbness Pfizer-BioNTech COVID-19 Vaccine EUA - Lips tingled 2 minutes after injection, then moved to tongue.... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - Lips tingled 2 minutes after injection, then moved to tongue. Lips started to go numb along with tongue, face started to itch right after. Within 30 minutes of injection, eyelids were swelling, face and chest redness, whole body itching. Benadryl and Tylenol taken, symptoms were lessening within 1 hour of taking Benadryl.
39 2021-01-12 swollen tongue Patient had the initial Pfizer COVID vaccine on December 18th. She started to having arthralgias, m... Read more
Patient had the initial Pfizer COVID vaccine on December 18th. She started to having arthralgias, myalgias, fever, fatigue and weakness starting on December 20th. The patient continuously had arthralgias, myalgias and weakness for the next few weeks. Patient follow up with physical therapist once a week to work on muscle weakness. The patient continuously had arthralgias and myalgias until January 10th. Primary care provider on January 7th orders CBC, autoimmune and thyroid panel since patient was having ongoing myalgias and arthralgias. Patient postpone 2nd dose because side effects from previous vaccine were ongoing. Patient got 2nd dose vaccine on January 12th at 4:30pm. On January 13th at 11am the patient initially had nausea and arthralgias. Patient took Zofran 4mg ODT about 11:15am. 30mins later the patient tongue swelled. No lips swelling and no SOB. Patient immediately took liquid Benadryl 50mg to 75mg PO. Patient immediately drove to ED. Patient was observed until 2pm for signs and symptoms of allergic reaction. Patient was discharge and advised to take Benadryl 25mg to 50mg every 4 to 6 hrs prn allergic reaction, Patient took famotidine 20mg at 4pm along with 25mg of Benadryl PO. Tongue swelling began to decrease. Patient also had fever, myalgia and arthralgias at 4:30pm. Took Tylenol 1,000mg and symptoms subsided (fever, myalgia and arthralgias).
39 2021-01-13 ear discomfort Contract employee reports approximately 25 minutes after receiving her second covid vaccination she ... Read more
Contract employee reports approximately 25 minutes after receiving her second covid vaccination she began to experience mild numbness in and slightly below her right ear. She reports her hearing sounding "muffled" in her right ear. This employee was monitored for a total of 60 minutes in the observation area and reports no worsening of symptoms at the 60 minute mark and felt comfortable leaving the location. She reports having similar symptoms with the first Covid vaccination she received but denies reporting it to Employee Health department or submitting a report herself. She does state she reported the symptoms on the daily check-ins.
39 2021-01-13 mouth tingling, taste impairment Metallic taste in mouth x 5-10 minutes after receiving vaccine, treated with oral benadryl, tingling... Read more
Metallic taste in mouth x 5-10 minutes after receiving vaccine, treated with oral benadryl, tingling in lips and tongue, Solumedrol IM given and transported via ambulance to ED. Lung sounds and vital signs within normal throughout, no rashes.
39 2021-01-13 mouth tingling Tingling in side of tongue at 10 minutes after vaccine/ tingling on right side of cheek at 45 minute... Read more
Tingling in side of tongue at 10 minutes after vaccine/ tingling on right side of cheek at 45 minutes/ tingling on tongue & cheek; tingling on toes on right side of feet only/ tingling on foot; This is a spontaneous report from a contactable nurse (patient). A 39-year-old non-pregnant female nurse (patient) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular route of administration on the left arm on 29Dec2020 10:00 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no known allergies. Concomitant medications included multivitamins, ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), vitamin B complex, zinc, and curcuma longa (TURMERIC), all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient experienced tingling in side of tongue at 10 minutes after vaccine, tingling on right side of cheek at 45 minutes & tingling on toes on right side of feet only on 29Dec2020 10:15. The tingling on tongue & cheek went away, but she was still getting tingling on foot at times. This never happened to her before the vaccine. No treatment was given and events were reported as non-serious. The outcome of the event tingling on tongue & cheek was recovered on an unspecified date and of tingling on foot was not recovered. The patient had not been tested for COVID-19 since the vaccination.
39 2021-01-14 mouth numbness On my way home from work about 20 min after 2nd vaccine unable to swallow and tingling/numb sensatio... Read more
On my way home from work about 20 min after 2nd vaccine unable to swallow and tingling/numb sensation to right side of face. Lasted approximately 30-45 min. Since then intermittent right sided facial tingling, lip twitching/numbness thats lasts approximately 2 seconds then stops. Increasing in frequency 1/15/21 which is leading me to report symptoms and notify PCP. Today (1/15/21) alone has happened about 20 times
39 2021-01-14 pain in jaw Moderate Bilateral jaw pain with moderate headaches; started about 3-4 days after shot, persistent, ... Read more
Moderate Bilateral jaw pain with moderate headaches; started about 3-4 days after shot, persistent, constant- despite ice and ibuprofen. Pain is intense but manageable to go to work. I am getting really worried about this pain. No problem increased pain with eating, but or talking
39 2021-01-14 ringing in ears Ringing in ears; Nausea; Heart palpitations; heart rate elevated to 163; This is a spontaneous repor... Read more
Ringing in ears; Nausea; Heart palpitations; heart rate elevated to 163; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the right arm on 07Jan2021 12:30 at single dose for COVID-19 immunisation. Medical history included asthma. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT), levothyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR), and paracetamol (TYLENOL). The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported) in the left arm on 17Dec2020 at 12:30 at single dose for COVID-19 immunisation. The patient previously took amoxicillin and experienced allergies. On 07Jan2021 16:45, the patient experienced ringing in ears, nausea, heart palpitations, and heart rate elevated to 163. Clinical outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
39 2021-01-15 swollen tongue Swollen tongue and sob with decreased swallow
39 2021-01-16 sensitivity to light Sore arm at the injection site 24 hours post vaccine then symptoms of nausea, weakness, tired, head... Read more
Sore arm at the injection site 24 hours post vaccine then symptoms of nausea, weakness, tired, headache started 12/20/2020, 4 days post the vaccine. Went to the ER on the 12/21/20-12/22/20 due to increase headache, vomiting, diarrhea, dizzy, dry cough, weak/extremely fatigue. At the ER was given IV fluid, Zofran, Phenergan, tested for the Flu and Covid, also had blood work. All my blood work came back in normal ranges, FLU and Covid test were negative as well. Discharged from the ER with Phenergan, the next 3 days I had a migraine and had to be in a dark room with lights off, still very dizzy, tired, shortness of breath with movement, could not eat it made me nauseas. Called for follow up with PCP he then put me on steroids, for 7 days. 12/28 called PCP office again, was put on another round of steroid treatment with antibiotic. Was off work from 12/21/2020-01/02/21 due to the sickness post the vaccine
39 2021-01-17 visual impairment Kaleidoscope like visual disturbance, geometric shapes black and silver that appeared to shimmer. A... Read more
Kaleidoscope like visual disturbance, geometric shapes black and silver that appeared to shimmer. Appeared for 5-10 minutes. I took Tylenol/aspirin/caffeine combo OTC when I got home about an hour later in case was precursor to a migraine. Dull headache that worsened with bending my body so my head was below my waist started about an hour after taking the medication.
39 2021-01-18 taste impairment Metalic taste feeling of numbness in face with itching started within 25 min. I self medicated with ... Read more
Metalic taste feeling of numbness in face with itching started within 25 min. I self medicated with 25mg of Benadryl 15 min before injection because I had the same reaction to the first injection. However it did not prevent the reaction as I hoped it would this time. 30 min post injection I took another 25mg of Benadryl. Once med started working symptoms went away. At no time did I have difficulty breathing. By midnight I was woken by chills, body aches, and head ache (possibly secondary to the jaw clenching I woke up with too). I took tylenol which did not appear to help which is abnormal for me. Fever, chills, aches continued on throughout the night and through the day into the night. On tylenol fever was noted to be 100.6 Fahrenheit. I was finally able to sleep with tylenol and motrin by 10 pm on 18th for 8 hours. Next day temp was about 97.6 Fahrenheit with mild sweating throughout the day and aches had subsided. Today Jan. 19th all symptoms are gone.
39 2021-01-18 taste impairment Fevers as high as 103 Body aches chills Metallic taste in mouth Nausea vomiting Lasted 3 days
39 2021-01-18 mouth tingling TICKLING IN THE LOWER LIP, WHICH IS SLIGHTLY INFLAMMED
39 2021-01-18 ringing in ears About five-ten minutes after the injection, tinnitus began ( both ears)... Immediately, I notified t... Read more
About five-ten minutes after the injection, tinnitus began ( both ears)... Immediately, I notified the nurse overseeing the vaccination event, Then next day, I notified my primary. The tinnitus started to subside a little after about two weeks, but still there as of 1/19/2021. I have my second dose tomorrow...
39 2021-01-18 vision blurred Immediately following vaccine my entire chest began very hot. I was having hard time breathing. I ... Read more
Immediately following vaccine my entire chest began very hot. I was having hard time breathing. I started trembling a little and my vision became blurry. Doctors told me I had bad panic attack.
39 2021-01-19 dry mouth Began having chills, fever 101.6, dry mouth, headache and body ache. Took ibuprofen and fever subsid... Read more
Began having chills, fever 101.6, dry mouth, headache and body ache. Took ibuprofen and fever subsided. Still having chills and extreme fatigue. Fever came back again.
39 2021-01-19 ear congestion day after 2nd injection increased fatigue, arm soreness and shortness of breath overnight requiring ... Read more
day after 2nd injection increased fatigue, arm soreness and shortness of breath overnight requiring rescue inhaler. Fatigue and general malaise continued x 7 days with intermittent shortness of breath requiring use of rescue inhaler. (Prior to vaccine inhaler used 3/year post vaccine requiring inhaler 2x per day). Increased post nasal drip with shortness of breath at night 02-03am each night and head congestion ear fullness during day requiring rest increased benadryl and decongestant use.
39 2021-01-20 eye disorder Received the vaccine and waited for 15 min within 10 minutes left arm had a warm heat through to che... Read more
Received the vaccine and waited for 15 min within 10 minutes left arm had a warm heat through to chest to her neck , head and throat . Felt like eyes had to adjust . Hot flushing sensation and got cold water to south her thought. Stayed for an additional 30 minutes . Check Blood pressure was 154/95 and heart rate of 120 We to the ER for observation. 1 hour from the physician 184/96 pulse 121 admitted for observation. Benadryl for observation for 2 hours
39 2021-01-20 hearing loss, deafness unilateral Hearing loss; This is a spontaneous report from a contactable Nurse Anesthetist (patient). A 39-yea... Read more
Hearing loss; This is a spontaneous report from a contactable Nurse Anesthetist (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL0140) on 18Dec2020 at single dose in the left deltoid for COVID-19 immunization.Medical history included ongoing anaemia. There were no concomitant medications. On 06Jan2021 at 16:00 the patient experienced hearing loss, serious as medically significant. Patient had no problems with her ears before hand. On 06Jan2021 around 4 PM, she was just walking in the store, with no loud music or anything, and all of a sudden her hearing in her left ear went lost and muffled. On 07Jan2021 she went to the Otolaryngologist (ENT doctor) to get her ears checked. They said no it looked perfectly fine. They did an audiogram and hearing test on 07Jan2021 and there was a 20% hearing loss. She had no idea what it was from. She took no other medications. She had anemia but that was it. She was wondering if hearing loss has been reported with the vaccine either in the studies or recently. She researched it, and with the COVID virus itself, back in Jul2020 and Oct2020, people reported hearing loss. So she went and had a COVID test in Jan2021 and it was negative. Patient stated it was very scary and weird. Event treatment included high dose oral steroids to see if it can be treated and the ENT doctor was also giving her steroid shots in the ear. She was due to see him again in Jan2021. The outcome of the event Hearing loss was not recovered. Patient also clarified that she did continue with her second dose of the vaccine on 08Jan2021. She had asked the ENT doctor his opinions on still getting the second dose, and he recommended it. The second dose of the vaccine was given on 08Jan2021 (lot EL3302, EXP: May2021) at single dose in the left deltoid for COVID-19 immunization.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hearing loss cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-01-20 pain in jaw Started with headache, feeling flush/hot and right side jaw pain around 4pm. At 2am woke up freezing... Read more
Started with headache, feeling flush/hot and right side jaw pain around 4pm. At 2am woke up freezing with the chills, started vomiting and diarrhea. Had a fever of 99.9, extreme body aches, fatigue and joint pain. Around 2:30 pm the body aches eased a little. I continued with a fever into the evening. Woke up the next day feeling fatigued and weak. Finally felt better on 1/16.
39 2021-01-20 mouth tingling 4 minutes post vaccine pt began to have tingling of face, tongue and throat pt states that she also ... Read more
4 minutes post vaccine pt began to have tingling of face, tongue and throat pt states that she also felt that her throat was starting to close and felt mild SOB
39 2021-01-20 swollen tongue Pt reports that immediately after receiving pfizer covid vaccine, she began to feel like her tongue ... Read more
Pt reports that immediately after receiving pfizer covid vaccine, she began to feel like her tongue was swelling. She was given liquid benadryl. No rash/hives/lip swelling/eyelid swelling/diarrhea. Similar feeling w eating scallops, but also never had swollen lips/rash. Denies voice change/wheezing/sob/cough.
39 2021-01-21 loss of taste Fever, body aches , joint pain, dry cough, loss of taste of spice only. All symptoms resolved except... Read more
Fever, body aches , joint pain, dry cough, loss of taste of spice only. All symptoms resolved except loss of taste of spice. COVID test neg.
39 2021-01-21 blindness in both eyes Extreme facial swelling, closing of throat, loss of vision in right eye, uveitis, extreme fatigue, h... Read more
Extreme facial swelling, closing of throat, loss of vision in right eye, uveitis, extreme fatigue, headache
39 2021-01-21 mouth numbness facial numbness to right side of face, crossing midline at chin and across upper lip, spreading from... Read more
facial numbness to right side of face, crossing midline at chin and across upper lip, spreading from jaw line to periorbital area
39 2021-01-21 lip swelling Angioedma to top lip. Started with swelling to chin area and the moved to top lip being fully swolle... Read more
Angioedma to top lip. Started with swelling to chin area and the moved to top lip being fully swollen. Seen at urgent care, given decadron injection in left butt cheek
39 2021-01-21 lip swelling hives, swelling of upper lip, localized to one area. No SOB, no throat swelling. Observed for addi... Read more
hives, swelling of upper lip, localized to one area. No SOB, no throat swelling. Observed for additional 20 minutes and 1 dose (12.5 mg) of Benadryl given. Some improvement noted. Patient advised to call 911 if symptoms worsen. Will need 30 minutes of observation for second dose.
39 2021-01-21 mouth tingling Tingling on lips and back of tongue, coughing-6 minutes after vaccine given
39 2021-01-21 swollen tongue 30 min after dose, thickening in back of throat, swelling of tongue, continued to worsen over the ne... Read more
30 min after dose, thickening in back of throat, swelling of tongue, continued to worsen over the next 24 hours, then tightening of airway. Treated with Benadryl, albuterol, Pepcid and then required 4 days of oral steroids for airway inflammation
39 2021-01-21 visual impairment Patient began to complain of shortness of breath, tingling in left arm (in which she received the va... Read more
Patient began to complain of shortness of breath, tingling in left arm (in which she received the vaccine), dizziness, and "seeing spots" approximately 5 minutes after administration of COVID-19 vaccine. Patient was found to have low blood pressure of 86/58. A code blue was called by COVID clinic staff. Upon rechecking vitals, the patient's blood pressure had improved to 136/79 and her oxygen saturation on room air was 100%. The patient was advised to go to the emergency department for continued monitoring but refused.
39 2021-01-22 eye pain, vision blurred Significant eye pain, swelling, puffiness, blurry vision, and headache, disorientation. started 3 ho... Read more
Significant eye pain, swelling, puffiness, blurry vision, and headache, disorientation. started 3 hours after receiving second dose of covid/pfizer vaccine and continues 2 days later. Has NOT resolved
39 2021-01-23 vision blurred racing heart rate and throat was itchy. slight blurry vision patient received IM Benadryl 50 mg sy... Read more
racing heart rate and throat was itchy. slight blurry vision patient received IM Benadryl 50 mg symptoms resolved 30 minutes later
39 2021-01-24 loss of smell, loss of taste Cough, SOB starting on 1/9. Loss of taste and smell starting 1/10 and still hasn?t returned. Dizzine... Read more
Cough, SOB starting on 1/9. Loss of taste and smell starting 1/10 and still hasn?t returned. Dizziness and fatigue on 1/10 as well
39 2021-01-24 eye strain 1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdo... Read more
1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdominal cramping for the rest of the day. I took some ibuprofen. The following morning (Wednesday), the pain was on my right abdomen and right flank area only. It was persistent, achy, soreness. My insides felt very tender to put any pressure on my right abdomen or flank. The pain on the right side of my back became more intense as the day went on. I had sharp right flank pain when lifting my right leg after showering to get dressing and use lotion. When I was walking up the stairs I turned to the left and had a sharp pain in the right flank again, taking my breath away for a moment. Around 4pm I took ibuprofen. About an hour later my eyes felt hot and tired. My cheeks were pink. My temp was 99.2. I generally just didn't feel good from this achiness. I took Benadryl and went to bed at 7pm, and slept for about 12 hours, waking once at midnight. The following day (Thursday) I felt 99% better and contacted my doctors office. When putting pressure on the same areas I could feel very slight tenderness if I pushed hard. That evening and into the next morning (Friday) I was mildly achy on my right side but barely at all. I didn't feel any more discomfort until this past week on the 22nd or 23rd. During sexual intercourse I felt that same mild internal tenderness on my right side. At this time, I don't believe I have any pain. My urine seems unusually clear, light colored, and smaller volume but this is very subjective. I have some abdominal swelling but this has been present since my breast reconstruction in January of 2020 and seems to get worse or better depending on the days activities or meals so it's hard to know what causes what. Labs were done on 1/22 showing decreased kidney fuction. Pending tests include an ultrasound of the Right Ovary that remains after the hysterectomy, bladder, and kidney. In addition to a 24 hour urine and some other urine studies.
39 2021-01-24 pain in jaw, ear discomfort Recieved the 2nd dose of Covid on 1/21/2021 at 8am the symptoms started that night around 9pm. Fat... Read more
Recieved the 2nd dose of Covid on 1/21/2021 at 8am the symptoms started that night around 9pm. Fatigue, achy, and nausea. Wake up at 11pm with fever 104.8, ears pounding, dizziness, swollen elbow and hand pain on same arm of injection. Fever over the next 24hrs went to 105.9. Nausea and extreme jaw pain and joint pain. fever resolved after 26hrs. Still having dizziness, arm around injection site is warm to touch, swollen, and joint painful. headache and neck pain still. treating with motrin and tylenol that was started 26hrs after the injection.
39 2021-01-24 mouth tingling, mouth numbness 20 min after the injection my lips started tingling and getting numb. Under my nose was numb, felt l... Read more
20 min after the injection my lips started tingling and getting numb. Under my nose was numb, felt like I had novacaine. 1 hour and 30 minutes later my throat swelled. I had a hard time getting water down my throat. I took two benadryl pills at 11:10 am. Throat swelling went away within 10 minutes of taking benadryl and I was able to eat without any issues. My lips are still tingling, it's been 7 hours since the injection.
39 2021-01-24 swollen tongue Swollen tongue and swollen lymph nodes throat
39 2021-01-25 taste impairment, mouth numbness, taste disorder First vaccine on 12/30/20 almost immediately after receiving vaccine metallic taste in mouth, follow... Read more
First vaccine on 12/30/20 almost immediately after receiving vaccine metallic taste in mouth, followed by itchy throat and felt throat slightly thighten took Benadryl and received relief Second dose on 1/20/21 took a Zyrtec per doctor?s instruction prior to receiving vaccine about 15 minutes after receiving second dose tongue numbness and weird taste in mouth now and developed itchy face, managed with Zyrtec although itchiness not resolved, taking Zyrtec every day since second dose, yesterday 1/25 in afternoon still medicated under Zyrtec face began to swell on left side of face, persistent itchy face, itchiness went down to other areas including neck, chest, bumps on left hand now on an oral steroid per my doctor
39 2021-01-25 mouth tingling 1/15/21 Tingling in lips, fingers and arms 1/16/21 Right sided facial numbness
39 2021-01-25 mouth tingling Left lower lip and Left tip of tongue tingling. Symptoms remain after 3 weeks
39 2021-01-25 mouth tingling 1:08 Injection; 30 min wait time , 1:40 Tingly lower lip and dizzy 1:45 Benadryl 50mg; bp 122/7... Read more
1:08 Injection; 30 min wait time , 1:40 Tingly lower lip and dizzy 1:45 Benadryl 50mg; bp 122/72 HR 83, pox 99 2pm still dizzy ", somewhat ; somewhat less tingly lip" couldn't give a scale 2:20 per DNS Deb, improved slightly. 2:30 very tired - may be contributed to 50mg Benadryl. 2:30 medical director examined. She feels okay, sent home with another staff member. Suggest contact her dr tomorrow and before next vaccine. Suggest do it at a medical facility.
39 2021-01-25 feeling of choking pt c/o of SVT. She is an MD. She c/o of tickling & lump in throat, refused Epi. Transferred to ER.
39 2021-01-25 swollen tongue Throat and tongue swelling that started a few minutes after the vaccine was given. No interventions ... Read more
Throat and tongue swelling that started a few minutes after the vaccine was given. No interventions were needed and the swelling subsided on its own within approx 2 hours.
39 2021-01-25 ringing in ears Ringing in ears; This is a spontaneous report from a contactable nurse (patient). A 39-year-old fema... Read more
Ringing in ears; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received bnt162b2, via an unspecified route of administration in left arm on 17Dec2020 16:00 (first dose, lot number: EJ1685, expire: unknown) at single dose, via an unspecified route of administration in left arm on 08Jan2021 09:00 (second dose, lot number: EL3246, expire: Apr2021) at single dose for COVID-19 immunization. Medical history included very frequent yeast infections that started about eight years ago, hypothyroidism from an unknown date and unknown if ongoing (she has been on medication her whole life). Concomitant medication included thyroid (ARMOUR THYROID) at 90 mg daily for hyperthyroidism (she has been on this particular medication about a year, but she has been on thyroid medication her whole life). The patient experienced ringing in ears on an unspecified date. She got two doses of Pfizer vaccine. It may be a coincidence. She started having intermittent ringing in ears and now it had been constant for 3 or 4 days in a row. She had continuous ringing in her ear and has never had problems with her ears before. It wasn't going away. She was at the point to go to the doctor. She honestly didn't know the date. She noticed it intermittently about the time she got the COVID vaccine. She didn't really pay much attention. She got the second shot about the time it started constantly. She couldn't say 100%, maybe it was coincidental. Caller clarified that she noticed intermittent ringing in the ears about the same time of the first dose. She noticed constant ringing about the same time as the second dose. She would rate seriousness criteria at a five, in the middle. It is not requiring hospitalization, but she would seek medical treatment if it didn't go away. The outcome of event was not resolved. Vaccination facility type was hospital. No additional vaccines administered on same date of the Pfizer suspect. The events were not required a visit to emergency room nor physician office at this time, but she was considering seeing her doctor or an ENT. No AE following prior vaccinations. No relevant tests.
39 2021-01-25 vision blurred Dizziness, lightheaded, difficulty focusing, seeing straight, reading
39 2021-01-26 lip swelling, mouth numbness 1/23/21 10:00 am, Developed lower lip and tip of tongue tingling post vaccination. Lower lip tinglin... Read more
1/23/21 10:00 am, Developed lower lip and tip of tongue tingling post vaccination. Lower lip tingling resolved 5 minutes later and tip of tongue tingling continued. Tip of tongue tingling resolved on 1/24/21. 1/25/21: 20:30 pm; developed sudden left leg numbness and left great toe tingling. 2100 pm left leg numbness decreased. Left great toe continued to have tingling sensation. Also had faint tingling right great toe. 1/26/21: 0800 am; left leg numbness improved. Left great toe continued to tingle. Right great toe tingling intermittent. New development of right index finger intermittent tingling. 1/26/21: 1000; Left leg numbness resolved. 1/27/21: Still remain with intermittent left and right great toe tingling and right index finger tingling.
39 2021-01-26 swollen tongue, mouth tingling 5 minutes after, lips tingling and swollen tongue/ tongue continued to be bigger than normal, doctor... Read more
5 minutes after, lips tingling and swollen tongue/ tongue continued to be bigger than normal, doctor onsite administered 2.5mg of epinephrine, felt relief within mins, however, after 15 minutes my tongue was tingling and swelling again. My throat, too was feeling swollen and scratchy. Was taken by the ambulance to the er where they gave me more medication to help with the swelling.
39 2021-01-27 mouth numbness, lockjaw Numbness around my mouth and my jaws wants to lock up like headache; Numbness around my mouth and my... Read more
Numbness around my mouth and my jaws wants to lock up like headache; Numbness around my mouth and my jaws wants to lock up like headache; Numbness around my mouth and my jaws wants to lock up like headache; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK4176), via an unspecified route of administration on 08Jan2021 at a single dose for covid-19 immunisation. Medical history included anxiety and some depression. Concomitant medication included sertraline hydrochloride (ZOLOFT) for anxiety and some depression, clonazepam for anxiety when it gets extreme. On an unspecified date in Jan2021, the patient experienced numbness around her mouth and her jaws wants to lock up like headache. The patient received ibuprofen, Tylenol and Advil as treatment for the event. The patient is due to receive second dose on 29Jan2021. The outcome of the events was unknown.
39 2021-01-27 eye discomfort After the first COVID19 shot I got very red and very hot. I had a blinding headache for days. I re... Read more
After the first COVID19 shot I got very red and very hot. I had a blinding headache for days. I received the shot on a Wednesday afternoon and by Saturday I felt like I could claw my eye out, that I had something in it. I went to the eye doctor Monday morning and was diagnosed with a corneal ulcer. After the second COVID19 shot I was watched for 30 minutes based on my first reaction. I again turned very red and very hot. I had hives on my arms, neck, and behind my ears. I felt lightheaded and dizzy. I received 25 mg Benadryl by mouth and was observed for another 45 minutes. At that time I walked outside and felt worse. My throat became very itchy and I kept coughing. I went back in to tell provider and received an epi pen injection into my right leg, they took my vitals, and sent me to the hospital by ambulance.
39 2021-01-27 eye discomfort left arm pain, right eye throbbing, right side headache, nausea, shortness of breath
39 2021-01-28 mouth tingling Tingling of tongue
39 2021-01-28 feeling of choking, mouth tingling tingling tongue and throat, self administered oral benadryl 50mg
39 2021-01-29 mouth numbness Extreme urticaria (itchiness). Mild hives on arm and redness on neck and arm. Numb lips. Took 50 mg... Read more
Extreme urticaria (itchiness). Mild hives on arm and redness on neck and arm. Numb lips. Took 50 mg diphenhydramine mild relief slept overnight normal in am, arm only sore
39 2021-01-29 ringing in ears, eyelid function disorder G4P1 prior uncomplicated pregnancy 35 +1 weeks pregnant EDD 27 Feb. That night I went to drink and ... Read more
G4P1 prior uncomplicated pregnancy 35 +1 weeks pregnant EDD 27 Feb. That night I went to drink and liquid came out my mouth spontaneously, my left side of face had lost normal wrinkles on forehead, eyebrow wouldn't lift, eyelid wouldn't blink, cheek couldn't puff, lips didn't smile. Next day (1) slight cheek numbness noted- resolved Day3 . Day 2 slight difficulty articulating words. Night 3 intermittent sharp outer ear and mastoid area pain duration 30min and at different times intermittent pulsatile heartbeat and whistling sound 10 min or less. Day 4 & 6 notable improvements in cheek ability to puff- not fully resolved though. Day 5 eyelid movement - not fully resolved though. Day 6: less difficulty articulating. Day 1: Spoke to OB office nurse- offered steroids which I declined & spoke to PCP recommended go to ED, which I declined, I'm a family physician and had otherwise normal Cranial nerve testing and no other neurological changes- seems fully consistent with Bell's palsy. Day 3 had co-worker physician use otoscope - normal exam bilaterally.
39 2021-01-30 taste impairment, dry mouth Metallic taste and dry mouth inmediately after injection that stopped on its own and lasted for less... Read more
Metallic taste and dry mouth inmediately after injection that stopped on its own and lasted for less than a minute. Severe headache migraneous type that started an hour after injection, treated with OTC Acetaminophen at home but did not resolved until 6 hrs later. Moderate Myalgia and general malaise without fever or chills that started 20 hours after injection and was treated with Ibuprofen and bed rest at home. Lasted 12 hrs aprox.
39 2021-01-31 loss of smell Loss of smell, diarrhea, headache and tiredness
39 2021-01-31 ear discomfort Day 1: numbness, pins and needles to bilateral lower legs. The pain was severe. They felt frozen. Bo... Read more
Day 1: numbness, pins and needles to bilateral lower legs. The pain was severe. They felt frozen. Body aches ascended from feet up to shoulders and then head. This lasted for 6 hours. Severe pain. Tylenol and ibuprofen did nothing. I could not focus my eyes on an object, and my ears stayed plugged, I kept trying to pop them. My throat became raspy and irritated. (Symptoms started at 16 hrs) Day 2: started having fever symptoms at hr 22, cold sweats and malaise. Couldnt get out of bed.. charley horse cramps to legs, and lower back pain. Gatorade and water didnt seem to help. I became tachycardic. I was all alone and didn't have the energy to take my vitals, I wish I had, but I know my heart was bounding quickly. Im sure I was very dehydrated. My normal HR is 70-80s. Day 3: find my right axillary node is hard and swollen, my right arm still hurts too. General body pain and fatigue still, finally able to get out of bed. Day 4: (today)out of bed most of day but in pain still, fatigued. Lymphadenopathy to right axillary still. Called out from work. Im an RN, and have chosen not to go to the E.R for prolonged symptoms. If I am still symptomatic tomorrow I will. I have a dr. Appt in 2 days with a new primary care doctor.
39 2021-01-31 mouth numbness I had complete numbness on my right side of my tongue and right cheek. The tongue lasted one hour an... Read more
I had complete numbness on my right side of my tongue and right cheek. The tongue lasted one hour and my cheek four hours
39 2021-01-31 mouth itchiness, mouth swelling, swollen tongue, mouth pain Severe swelling, itching and pain in right side of mouth, chin and cheek. Swelling inside the mouth... Read more
Severe swelling, itching and pain in right side of mouth, chin and cheek. Swelling inside the mouth, itching, slight swollen tip of the tongue on the right side
39 2021-01-31 mouth tingling Approximately 40 minutes after injection, my tongue began to feel thick, my throat tight, and my fac... Read more
Approximately 40 minutes after injection, my tongue began to feel thick, my throat tight, and my face slightly numb. I spoke with a nurse and was given zyrtec. Within an hour, symptoms related to face and tongue were gone. Even 11 hours later, my throat feels like there is a small lump in it.
39 2021-02-01 mouth numbness Felt dizzy and nauseous soon after with difficulty swallowing/dysphasia for a few hours. Facial twit... Read more
Felt dizzy and nauseous soon after with difficulty swallowing/dysphasia for a few hours. Facial twitches. Arm pain in evening and next day that went away. Nausea remained and continues (9 days after so far). Evening 8 slight facial numbness and today day 9 face, throat and back of tongue feels slightly numb. Slightly shallow breathing. Dizziness and fatigue/malaise.
39 2021-02-01 lip swelling Started with a rash to my neck and chest. A day or a rash started to develop on my forehead, eye lid... Read more
Started with a rash to my neck and chest. A day or a rash started to develop on my forehead, eye lids and under one eye. Lymph node in my neck was also swollen. A week later my lips are slightly swollen, rash is better on my neck but is worse on my face.
39 2021-02-01 sensitivity to light Fever 102 (lasted 3 days) Chills (lasted 2 days) Full body aches (lasted 3 days) Severe muscle and ... Read more
Fever 102 (lasted 3 days) Chills (lasted 2 days) Full body aches (lasted 3 days) Severe muscle and joint pain/throbbing (lasted 3 days) Severe headache (lasted 2 days) Dizziness (lasted 1 days) Light sensitivity (lasted 2 days) Chest pressure/pain (continuing) Cough (continuing)
39 2021-02-01 photosensitivity reaction Hallucination on Day 1 and day 3. Lasted about 3-5 minutes followed by 36 hours of lethargy and phot... Read more
Hallucination on Day 1 and day 3. Lasted about 3-5 minutes followed by 36 hours of lethargy and photosensitivity. Shortness of Breath on Day 4.
39 2021-02-02 taste impairment Patient voiced having metallic taste in mouth and had mild redness on chest and stated chest felt wa... Read more
Patient voiced having metallic taste in mouth and had mild redness on chest and stated chest felt warm. Patient denied any itching.
39 2021-02-02 ear pain, toothache Fever, chills, body aches, sore teeth, ear pain
39 2021-02-02 eye irritation, bloodshot eyes I received COVID vaccine #1 on 6 Jan 21. Shortly following the vaccine I turned very red and felt v... Read more
I received COVID vaccine #1 on 6 Jan 21. Shortly following the vaccine I turned very red and felt very hot. The next few days I experienced a very bad headache and flu like symptoms. On 9 Jan 21 my left eye felt very irritated and had redness. I was seen by optometry on 11 Jan 21 and was diagnosed with a corneal ulcer. I received COVID vaccine #2 on 27 Jan 21. I was observed for 30 minutes based on the first vaccine experience. I got very flushed, red, and hot and very itchy. I felt lightheaded and not right. I had hives behind my ears and on my chest. I notified one of the vaccine staff who gave me 25mg Benadryl by mouth and took my vitals. The staff observed me for another 45 minutes. Once I went outside the back of my throat felt very itchy. I felt like I had something in my throat and I had to keep trying to clear my throat. I got very red, hot, and itchy again. I went back inside to tell the staff. They gave me an epi pen injection into my right thigh and called the ambulance. I was taken to the ER to be evaluated. Two days later I noticed the back of my throat was very red and my uvula was large and elongated. I called the clinic and was given cough drops and Cepacol. I have been experiencing hives, redness, and feeling very itchy. To a point I have been having to take Benadryl. I took the 5 days of steroids and ended them on Monday. Yesterday, 2 Feb 21 I woke up and my right eye was bloodshot, irritated, and uncomfortable. I was seen at Urgent Care and prescribed Ofloxacin 4x a day for 10 days. They did not notice any scratches or anything. My right eye is still uncomfortable and red. I am currently on day two of the eye drops.
39 2021-02-02 mouth numbness Sweaty palms, numb lips, cold sweats, shakiness
39 2021-02-03 eye pain, pain in jaw Two days after receiving the vaccine patient experienced flu-like symptoms, body aches, nausea, and ... Read more
Two days after receiving the vaccine patient experienced flu-like symptoms, body aches, nausea, and swollen lymph nodes in the armpit. The next day she had eye and jaw pain, and burning up and down her arm which she believes is the start of shingles
39 2021-02-03 lip swelling, lip redness Patient lips begin to swell 20 minute after receiving covid19 Vaccine. Patient had left clinic and... Read more
Patient lips begin to swell 20 minute after receiving covid19 Vaccine. Patient had left clinic and returned due to the swelling of lips. At the time of return swelling to lips were slightly visible with some redness. Client refused treatment of benadryl intramuscular due to driving to site. She stated she felt fine after additional observation period of 30 minutes. Vital signs Heart rate 89 BP 132/64 Sp02 98% Resp. 18 . Followed up with client on 02/04/2021. Client stated she took OTC benadryl once returning home w/ no complaints today.
39 2021-02-03 vision blurred I received the 1st dose of my covid vaccine on Thursday 1/7 at 4pm and during my 15 min observation ... Read more
I received the 1st dose of my covid vaccine on Thursday 1/7 at 4pm and during my 15 min observation I started to not feel well, light headed, spacey, eyes blurry. I sat and was observed til approx. 1715 at which time I thought I was ready to head back to my department. After the elevator to the LL I really wasn't feeling well. I ended up going to the ER which they diagnosed me with Vertigo. I have never had vertigo in the past. I remained in the ER until approx. 2220 until my symptoms were managed with medication and I felt well enough to leave.The lightheaded and dizziness lasted a few days while the headaches lasted about a week.
39 2021-02-05 lip itchiness Facial swelling, neck swelling, dizziness, shortness of breath, nausea, warm feeling, lips itchy, fa... Read more
Facial swelling, neck swelling, dizziness, shortness of breath, nausea, warm feeling, lips itchy, face itchy
39 2021-02-05 mouth tingling, swollen tongue After about 30 minutes I experience swelling and tingling to my tongue. I also experienced some dizz... Read more
After about 30 minutes I experience swelling and tingling to my tongue. I also experienced some dizziness. The swelling and tingling dissipated after about 4 hours, and I took some 20mg PO Pepcid and 10mg Loratidine to see if it would help. After 6-8 hours the swelling and tingling to my tongue was gone. I reported this to my provider Manaku MD, and she recommended it was fine to get my second vaccine, and she would give me a methylprednisone taper pack for the next vaccine. She states she questions if I have an allergy to polyethylene glycol which I did not believe I did? Unsure of where the reaction could have stemmed from.
39 2021-02-05 swollen tongue, tongue itchiness Patient reported itching of posterior tongue, under further observation and over 10 minutes, worseni... Read more
Patient reported itching of posterior tongue, under further observation and over 10 minutes, worsening itching to tongue and swelling sensation, noted by PA starting to clear throat and having more forceful swallowing. Patient reported difficulty swallowing. Administered epinephrine 0.3 mg IM and diphenhydramine 50 mg IM (IV line could not be started). Patient mild hypertension but other vitals stable. EMS called and patient transported to ED for further evaluation.
39 2021-02-06 visual impairment At or around 2300 on 2/4/2021 I began feeling tense, major body aches, and had a temp of 99.6°. I w... Read more
At or around 2300 on 2/4/2021 I began feeling tense, major body aches, and had a temp of 99.6°. I went to emergency department for nausea vomiting. Dizziness. Seeing stars when moving, and rapid heart beat that would not stop and my chest began hurting. Dr saw me in the Ed where I was administered iv bolus fluids along with the meds: toradol, dexamethasone, pepsid, Benadryl, and zofran. I went home and laid on the couch all evening until the chest pain became so intense I went to new medical center emergency department. I was then given iv fluids along with phenergan, toradol, dilaudid, and Ativan. I got a chest X-ray, ecg, ekg, and a bunch of blood work to rule out things.
39 2021-02-07 deafness, ringing in ears, hearing loss Hearing loss to certain tones/pitches Muffled and ringing in ears
39 2021-02-07 tongue itchiness Patient is a 39 y.o. female presenting to ED with itchy tongue and throat which occurred 1 hour afte... Read more
Patient is a 39 y.o. female presenting to ED with itchy tongue and throat which occurred 1 hour after second dose of COVID-19 patient received vaccination this morning. Patient states symptoms started an hour and a half after vaccine administration. Patient denies rash or swelling. Patient received 50 mg of Benadryl for presentation. Patient will be discharged and instructed to follow up with primary care doctor in 1-2 days and return to the ED if symptoms worsen. Symptoms believed to be from allergic reaction, nausea. Pt received atarax, pepcid, zofran, decadron.. Patient will be discharged with atarax, epipen. Pt has no oral swelling on repeat exam.. Patient understands and agrees with plan.
39 2021-02-08 loss of taste Around 6am on Sunday, the day after I received the vaccine, I woke up with the following symptoms: ... Read more
Around 6am on Sunday, the day after I received the vaccine, I woke up with the following symptoms: injection site pain, fatigue, headache, chills, fever, nausea, swelling in my under arm and loss of taste. I was out for the entire day. On Monday, I woke up with the same symptoms but they were milder than the day before. I called to schedule an appointment with my doctor today, Tuesday, to go over my reaction to the vaccine. I still have swelling under my arm and loss of taste and fatigue.
39 2021-02-08 lockjaw Immediately after her second Covid vaccine injection, she began to have a cluster headache and felt ... Read more
Immediately after her second Covid vaccine injection, she began to have a cluster headache and felt flushed. O2 was administered for 15 minutes to treat headache. All vitals were normal Cardiopulmonary assessment was normal. All abnormal feelings resolved prior to her leaving the vaccine clinic approximately 45 minutes after injection. Later that day, she started to have "lockjaw" symptoms and went to her PCP. She received an IM injection of dexamethasone and has been fine since.
39 2021-02-09 loss of taste Patient developed body aches 2/08/21 and loss of taste. She is covid+ today.
39 2021-02-09 loss of smell body aches; She feels like she has shortness of breath; feeling really tired/fatigued; chills and sw... Read more
body aches; She feels like she has shortness of breath; feeling really tired/fatigued; chills and sweats; chills and sweats; sore at injection site; lost sense of smell; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318), intramuscular in left deltoid on 23Jan2021 15:35 at SINGLE DOSE for covid-19 immunisation. She typically got sick when she got the flu vaccine or any vaccine in general for immunization, she got deathly sick. She always got the flu after getting the flu vaccine. She did not get the flu shot this year and she did not get the flu. She did not know the name of the flu vaccine or any vaccine that she was referring to and she did not have lot number to provide. Other medical history was reported as none. There were no concomitant medications. Relevant Tests were reported as none. The patient experienced lost sense of smell on 23Jan2021 with outcome of not recovered, feeling really tired on 24Jan2021 with outcome of not recovered, chills and sweats on 24Jan2021 with outcome of recovered on 25Jan2021, sore at injection site on 24Jan2021 with outcome of not recovered, body aches and Shortness of breath on an unspecified date with outcome unknown. Details were as follows: the patient had a list of the expected side effects and she did not see loss of sense of smell on the list. Reported she completely lost her sense of smell, she cannot smell anything at all. She was asking if she should be concerned. On Friday prior to getting the vaccine she could smell everything. She thought the loss of smell started Sunday, reported it may have started Saturday (23Jan2021). She noticed when she put her body spray on Sunday and she was washing her hands that she could not smell. She can taste fine. She can handle the body aches and all the other stuff. She clarifies she was experiencing body aches, she was feeling really tired, fatigued. She was feeling better. She could not call earlier because she was so tired. She had the chills and sweats that started Sunday evening and recovered today (25Jan2021). Reported her sheets were drenched with sweat when she woke up. She did not have a fever. She thought most of her side effects started Sunday night. Reported the injection site was sore and that started the day after receiving her injection, it was still sore. She did not go to work today (25Jan2021). She felt like she had shortness of breath but she was checking her oxygen level and it was fine, stated it just felt like she was short of breath and it was ongoing and persisting. No additional vaccines Administered on Same Date. The events did not require a visit to Emergency Room and Physician Office.
39 2021-02-10 eye pain I had a migraine beginning Feb 9 AM. I have chronic migraines that almost always occur on the left s... Read more
I had a migraine beginning Feb 9 AM. I have chronic migraines that almost always occur on the left side of my head, but this one was on the right side, which is unusual for me. The migraine pain was more severe than normal. I also had a stiff right jaw and eye pain primarily on the right side. I took 100 mg Imitrex in the afternoon of Feb 9 and it reduced the pain very effectively (which is also unusual for me). On Feb 10 AM, the migraine returned or a new one started. The pain was also in the right side. I took 100 mg Imitrex and it reduced the pain somewhat effectively. The migraine pain returned Feb 11 AM and hurt on both sides of my head. I took 100 mg Imitrex this evening (Feb 11) and it is helping so far. In addition, my left arm was sore around the injection site beginning when I got the shot and stopped this morning.
39 2021-02-10 mouth numbness, mouth tingling my throat started swelling; had a hard time drinking water, felt like the water was going to come ou... Read more
my throat started swelling; had a hard time drinking water, felt like the water was going to come out of my nose; my lips started tingling and getting numb; my lips started tingling and getting numb; Under my nose was numb, felt like I had novacaine; This is a spontaneous report from a contactable other health professional reporting for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3246), via an unspecified route of administration on 25Jan2021 09:30 at SINGLE DOSE (2nd dose, Arm left) for COVID-19 immunization. Medical history included Allergies: Hair dye, henna dye, Allergies: latex, and Allergies: metals with the exception of gold from an unknown date. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021, 10:30 (lot number: EL3246, age of vaccination 39 years old) for COVID-19 immunization. Concomitant medication included cetirizine hydrochloride (ZYRTEC) from an unspecified date for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient received the vaccine at public health clinic/facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Jan2021 at 09:50, 20 minutes after the injection (Also reported as 09:15 AM), the patient experienced her lips started tingling and getting numb. Under her nose was numb, felt like she had novacaine. At 11:00, 1 hour and 30 minutes after the injection (also reported as 09:30 AM), her throat started swelling, had a hard time drinking water, felt like the water was going to come out of her nose. She took two BENADRYL pills and the throat swelling went away within 5 minutes. She stated she eats and had no issues regarding swelling. Her lips were still tingling and it has been 8 hours since getting the injection. Therapeutic measures for the events included BENARDRL. Outcome of the events her lips started tingling and getting numb (tingling lips) was not recovered; Outcome of the events her lips started tingling and getting numb (numb lips), Under her nose was numb, felt like she had novacaine, had a hard time drinking water, felt like the water was going to come out of her nose was reported as recovered/resolved with sequel, recovered with lasting effects (as provided by the reporter) on an unspecified date; while throat swelling recovered/resolved with sequel on 25Jan2021. The reporter considered the events as non-serious. No hospitalization was involved.
39 2021-02-10 swollen tongue After 9 minutes my tongue start to swell and tingle .. within a hour my mouth and lips started tingl... Read more
After 9 minutes my tongue start to swell and tingle .. within a hour my mouth and lips started tingling. My moth and lips felt as if they were swollen
39 2021-02-10 eye floaters, visual impairment, eye bleeding A few hours after receiving the vaccine, I developed fevers lasting until 3 days as high as 104.7, s... Read more
A few hours after receiving the vaccine, I developed fevers lasting until 3 days as high as 104.7, self-care of Tylenol and Iced towels. I started seeing spots/ floaters in my left eye. I made an appt the following day and was advised I had 3 hemorrhages in my left eye, the spots/floaters are still there. Fatigue, full body pain, vomiting lasted one day, the day after the vaccine, dizziness and Tenderness in left arm where the vaccine was given, still slight pain 3 weeks later.
39 2021-02-11 pain in jaw 1st vaccine 01/15/2021; 2nd dose 02/05/2021; seen at care center 12/12/2021 for new onset jaw pain a... Read more
1st vaccine 01/15/2021; 2nd dose 02/05/2021; seen at care center 12/12/2021 for new onset jaw pain and swelling onset 12/12/2021.
39 2021-02-15 mouth tingling Patient reported reaction to first vaccine. After receiving dose, resident started feeling dizzy (at... Read more
Patient reported reaction to first vaccine. After receiving dose, resident started feeling dizzy (at 3:15pm). at 3:25pm patient reported tingling of the bottom lip. Both resident reported with previous dose. AT 3:50PM patient reported no change, and reported to director of nursing that legs felt "heavy" and that her legs had fallen asleep. She did not want Benadryl. Director of nursing let staff member leave facility around 4:10pm, with another nurse driving her home after confirming resident felt well enough to leave.
39 2021-02-15 ringing in ears Ringing in ears (tinnitus), Constant for 4 weeks (and still taking place) plus severe neck pain and ... Read more
Ringing in ears (tinnitus), Constant for 4 weeks (and still taking place) plus severe neck pain and pain in back of head.
39 2021-02-16 lip swelling I have had dermal fillers in my lips and about 18 or 20 hrs after vaccine i had swelling on my upper... Read more
I have had dermal fillers in my lips and about 18 or 20 hrs after vaccine i had swelling on my upper lip two and half days .
39 2021-02-16 swollen tongue Anaphylaxis: After my second dose of the vaccine within 3-5 minutes I stared feeling swelling of th... Read more
Anaphylaxis: After my second dose of the vaccine within 3-5 minutes I stared feeling swelling of the thong, itchy throat, head, neck, sob. I immediately reported my symptoms to the MD that was in the room monitoring the recent vaccinated employees. Immediately he administered 50mg of Benadryl, 20mg of Pepcid, and salbutamol. I was rushed to the ED and stayed there for couple of hours headed back to my unit and then sent home by my manager.
39 2021-02-16 ringing in ears Tachycardia, dizziness, weakness within 5 minutes of receiving injection. Moderate tinnitus several... Read more
Tachycardia, dizziness, weakness within 5 minutes of receiving injection. Moderate tinnitus several weeks following injection.
39 2021-02-16 lockjaw jaw spasms on the left side of face near TMJ; Involuntary jaw closing; This is a spontaneous report ... Read more
jaw spasms on the left side of face near TMJ; Involuntary jaw closing; This is a spontaneous report from a contactable consumer (patient) reported that a 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right arm on 29Jan2021 17:45 at a single dose for covid-19 immunization. The vaccine was administered at the Health Department. The patient also received the first dose of other vaccine (reported as Pfizer brand) via an unspecified route of administration on the right arm on 29Jan2021. Medical history included tinnitus from an unknown date, and allergy from quinoa. Patient is not pregnant at the time of the vaccination. Concomitant medications included ergocalciferol (VIT D), and fexofenadine hydrochloride (ALLEGRA). The patient previously took, neosporin [neomycin sulfate;polymyxin b sulfate] and experienced drug allergy. On 02Feb2021 08:00, the patient experienced jaw spasms on the left side of face near TMJ, and involuntary jaw closing when teeth were very close to each other. The reported events was resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
39 2021-02-17 dry mouth Throat tight, hard to swallow, extreme dry mouth, chills, shaking, anxiety
39 2021-02-19 ear pain Nausea fever of 102.1, hot flashes, headache, ear pains, diareah, body cramping
39 2021-02-20 loss of taste, loss of smell 2/17/21 at 7:00pm; extreme fatigue, massive headache, chills, nausea; couldn?t stay awake, slept for... Read more
2/17/21 at 7:00pm; extreme fatigue, massive headache, chills, nausea; couldn?t stay awake, slept for 12 hours. 2/18/21 at 7:00am; difficulty waking; fatigue, muscle and joint pain; moderate headache; nausea; diarrhea; dizziness, minimal relief with Tylenol and Tums. Continued all day. 2/19/21 all day; muscle and joint pain, fatigue, chills; dizziness 2/20/21 all day; headache at least twice and dizzy spells at least four times; fatigue, chills; temperature ranged between 95.4-96.2; nausea; lost of taste 2/21/21 all day, no headache; chills; inability to stay warm, inability to taste (even tried straight sugar and daughters sour candy), dizzy spells so far three times. No loss of smell.
39 2021-02-20 lip swelling, swollen tongue Within 10-15 minutes started experiencing swelling of the tongue and lips. Was taken to the local ER... Read more
Within 10-15 minutes started experiencing swelling of the tongue and lips. Was taken to the local ER where I was treated with steroids, benadryl. I was monitored for any other adverse reactions and released hours later once reaction resolved.
39 2021-02-20 eye discomfort, eye pain, sensitivity to light, bloodshot eyes, eye swelling One week after first Pfizer vaccine, awoke with severe right eye pain and light sensitivity. The eye... Read more
One week after first Pfizer vaccine, awoke with severe right eye pain and light sensitivity. The eye and peri-orbital area was extremely painful, swollen and red. The ophthalmologist said the the urea and surrounding tissues were severely inflamed and the eye pressure was increased. He stated this could have been a delayed inflammatory response to the covid vaccine and advised to refrain from having the second dose. Took steroid eye drops every one hour for several days and have had three follow up ophthalmology visits.
39 2021-02-21 mouth tingling Welts on trunk, generalized pruritus, tingling on lips. Trapsorted to ED. Contacted by allergy - dec... Read more
Welts on trunk, generalized pruritus, tingling on lips. Trapsorted to ED. Contacted by allergy - declined consult.
39 2021-02-22 lip swelling, lip blister 2/2/2021- 1 day after vaccination, Pt. noted swollen upper lip (swelling greater than lower lip). Sl... Read more
2/2/2021- 1 day after vaccination, Pt. noted swollen upper lip (swelling greater than lower lip). Slight itching. 2/3/2021- patient noted blister on top lip open with blood and body aches started and lasted until 2/16. Pt. did mention during clinic that she does develop a similar reaction when she eats salmon- but does not have blisters on her lip. She has also never had a cold sore before.
39 2021-02-23 taste impairment metallic taste in mouth; itchy throat that felt constricted; itchy throat that felt constricted; Thi... Read more
metallic taste in mouth; itchy throat that felt constricted; itchy throat that felt constricted; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142) intramuscular on the left arm on 30Dec2020 10:30 at a single dose for COVID-19 immunization. Medical history included pre-diabetes and known allergies: Penicillin. Concomitant medication included escitalopram oxalate (LEXAPRO). Immediately after the 1st dose on 30Dec2020, the patient experienced metallic taste in mouth followed by itchy throat that felt constricted. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.
39 2021-02-23 mouth numbness, taste impairment tongue numbness; weird taste; persistent allergies; itchy face; This is a spontaneous report from a ... Read more
tongue numbness; weird taste; persistent allergies; itchy face; This is a spontaneous report from a contactable health care professional (patient). A 39-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8982, expiry date unknown), via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included pre-diabetes and allergies to penicillin both from an unknown date and unknown if ongoing. The patient concomitantly received cetirizine hydrochloride (ZYRTEC) as pre-medication and Lexi pro (as reported). The patient received the first dose of BNT162B2 (lot number: EL0142, expiry date unknown), intramuscular on 30Dec2020 at 10:30 AM on the left arm for COVID-19 immunization where the patient immediately after experienced metallic taste in mouth followed by itchy throat that felt constricted. Prior to vaccination, the patient has not had COVID-19. The patient has not been tested for COVID-19 post vaccination. The patient was premedicated with Zyrtec and 15 minutes after second dose had tongue numbness and weird tast on 20Jan2021 at 16:15 and itchy face started hours later and then continued with persistent allergies every day since the second dose until present was placed on oral steroid. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient received oral steroid and Benadryl as treatment for the events. The outcome of the events was recovering.
39 2021-02-23 thirst, taste impairment Day 1. Fever and shaking chills. Strong body pain. Treatment: Equate NiteTime and DayTime Cold & F... Read more
Day 1. Fever and shaking chills. Strong body pain. Treatment: Equate NiteTime and DayTime Cold & Flu, Naproxen 500mg. Day 2 to present. Diarrhea, heartburn, bitter taste, stomachache, thirsty, body pain. Treatment: Pepto bismol.
39 2021-02-25 pain in jaw, mouth tingling Within 30 minutes I had severe jaw pain, tingling in tongue and gums, and headache.
39 2021-02-25 mouth tingling Very hot, flushed immediately after injection. She felt panicky, lips, fingers/feet were tingling. ... Read more
Very hot, flushed immediately after injection. She felt panicky, lips, fingers/feet were tingling. She cooled down and was back to normal within 20 minutes of vaccination. No other events reported thereafter.
39 2021-02-25 mouth tingling Patient developed mild oral tingling and sensation of chest tightness while in COVID post-vaccinatio... Read more
Patient developed mild oral tingling and sensation of chest tightness while in COVID post-vaccination observation area. Diphenhydramine 25 mg/10 ml administered and patient observed for 30 min. Patient reported feeling well and left the observation in good condition.
39 2021-02-27 swollen tongue On third day after 2nd vaccine was given, urticaria appeared throughout my body, along with tongue ... Read more
On third day after 2nd vaccine was given, urticaria appeared throughout my body, along with tongue swelling, wheezing, flushing, and eye irritation. Because my daughter suffers from allergic reactions, I knew to immediately administer Benadryl. I also took an additional dose of Zyrtec and Pepcid, which helped temporarily and symptoms subsided when I called my primary care doctor. I had a virtual visit, and she then prescribed Medrol.
39 2021-02-28 thirst Sore arm. Feeling drowsy and sluggish. Sleepy. Not interested in eating large meals. Desire lots of ... Read more
Sore arm. Feeling drowsy and sluggish. Sleepy. Not interested in eating large meals. Desire lots of liquids and small bites of food.
39 2021-03-02 pain in jaw Client c/o a nerve discomfort from the vaccine site to the side of Left neck up to the jaw area. Adv... Read more
Client c/o a nerve discomfort from the vaccine site to the side of Left neck up to the jaw area. Advised client for another 15 minutes of observation. Client stated OK. NP was made aware and NP spoke with client. BP was taken at 146/84. Ox at 98% HR at 76, temp 98.7. Client was monitored for another 15 minutes BP was taken 10 minutes later with 143/83, Ox at 98, HR 75. Patient stated that she is okay. stated that the nerve discomfort is no longer present. Client left clinic stable with steady gait.
39 2021-03-02 mouth tingling Tachycardic, hr 112; hives on both arms, chest, face.; Lips were tingly; This is a spontaneous repor... Read more
Tachycardic, hr 112; hives on both arms, chest, face.; Lips were tingly; This is a spontaneous report from a contactable other hcp. A 39-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 16:00 at single dose, right arm for covid-19 immunization. Medical history included Anti Myelin oligodendrocyte glycoprotein(MOG) disease. Known allergies included prednisone, methyl prednisolone. Concomitant medication included cyclobenzaprine, celecoxib and duloxetine hydrochloride (CYMBALTA). There were no other vaccine in four weeks. The patient previously received first dose of bnt162b2 for covid-19 immunization. The patient had hives on both arms, chest, face. Lips were tingly. Tachycardic, HR 112. The patient took 75 mg diphenhydramine hydrochloride(BENADRYL) and became slightly better. Adverse events start date was 25Feb2021 16:30. Events resulted in [Life threatening illness (immediate risk of death from the event)]. The outcome of the events were recovering. The patient had no COVID prior vaccination. There was no COVID tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
39 2021-03-02 swelling around the eyes, eye swelling One week after each vaccine, my skin beneath my right eye started swelling, getting very red, and ve... Read more
One week after each vaccine, my skin beneath my right eye started swelling, getting very red, and very itchy. I look like I've been punched in the face. The first time, it lasted about 4-5 days before it went away. My vaccine date for dose #1 was Friday 1/29/21 and the swelling started on 2/5 (the following Friday). My second vaccine date was Monday 2/22 and the skin beneath the eye started reacting 3/2 (Tuesday). It itches a huge amount. The skin beneath the eye is dark red, and puffy. The skin beneath the left eye is normal.
39 2021-03-03 lip swelling Patient with no history of anaphylaxis had immediate lip swelling post vaccine, which resolved with ... Read more
Patient with no history of anaphylaxis had immediate lip swelling post vaccine, which resolved with 50 mg oral benadryl administered by EMS standing by. No transportation to hospital needed.
39 2021-03-03 swelling around the eyes, photosensitivity reaction, eye strain Information provided by patient as follows: Slight throat tightening within first 20 minutes and th... Read more
Information provided by patient as follows: Slight throat tightening within first 20 minutes and then after an hour had some amount of numbness in left side of face only. About after 4 hours, I had complete numbness of the left side of my face. The numbness persisted through the rest of the day. The day following the vaccine, the numbness still persisted in areas by my left eye and upper cheek area. After over a week, those areas are still affected. My left eye feels weak, photosensitive, and strained. I am experiencing frequent headaches and pain around/above my eye. I am also noticing intermitted numbness/tingling in my upper extremities and hands. Scheduled to see provider on 2/24/21 regarding if 2nd dose should be given (findings from that visit unknown)
39 2021-03-04 ringing in ears Within 5 minutes: dizzy, racing heart, lump in throat, strange feeling in face, exacerbated tinnitus... Read more
Within 5 minutes: dizzy, racing heart, lump in throat, strange feeling in face, exacerbated tinnitus. I think develop significant vestibular dysfunction - felt like I had been on a carnival ride or boat. It was acute for about 5-6 days and mild for 3-4 weeks following.
39 2021-03-06 ringing in ears Severe fever (104°), chills, nausea, joint pain, ringing in left ear
39 2021-03-07 mouth numbness, swollen tongue, mouth tingling Patient reported slight tongue swelling and "tingly and numb" lips after 1st dose of Pfizer. Patient... Read more
Patient reported slight tongue swelling and "tingly and numb" lips after 1st dose of Pfizer. Patient transported clinic, patient was given water to swallow, lips continued to be "tingly", 25mg of Benadryl was given by mouth by ENT. At 2pm patient stated lips were no longer tingling and was ready to go. BP 127/76, HR 108, O2 95%, Temp 97.9 F. Patient was picked up by Friend.
39 2021-03-07 feeling of choking Throat feeling inflamed and tingling, "my tonsils are closing on me" "throat is getting worse and so... Read more
Throat feeling inflamed and tingling, "my tonsils are closing on me" "throat is getting worse and so is my cough" Told through interpreter. Epi 0.3 mg (epi-pen) Mylan OFM407 expires 2/2022 given in left vastus lateralis at 515m
39 2021-03-07 vision blurred During end of 30 minute observation time veteran's arms appeared erythemic and splotchy. During ass... Read more
During end of 30 minute observation time veteran's arms appeared erythemic and splotchy. During assessment, she stated that she was feeling like her heart was racing, blurry vision, and dizzy. Denies SOB, no facial swelling noted, swallowing water without difficulty. Vital signs completed at approx. 1344: 194/116, 113 bpm, 16 rr. Repeated 5 minutes later as 176/113, 105 bpm. She later reported that symptoms first began about 15 minutes into timer. She was taken to ER, given IV Benadryl, monitored, and discharged home.
39 2021-03-09 lip swelling At 16:07, 12 minutes following administration of the Pfizer COVID-19 vaccine (dose #2), patient pres... Read more
At 16:07, 12 minutes following administration of the Pfizer COVID-19 vaccine (dose #2), patient presented with a swollen lip, hives, and itching. Patient denied shortness of breath, difficulty breathing, tightness in throat. 25 mg diphenhydramine was administered orally at 16:08. Patient was admitted to ED for care where IV methylprednisolone, IV diphenhydramine, and IV famotidine were administered between 16:30-16:36. Patient reported decreased swelling and itching at 17:15. Provider at bedside and cleared for discharge with home meds at 18:00.
39 2021-03-09 oropharyngeal discomfort I felt like their was a frog in my throat and my throat was starting to close 20 minutes after the v... Read more
I felt like their was a frog in my throat and my throat was starting to close 20 minutes after the vaccine. Fire Department checked me out and advised that I go home and take Benadryl.
39 2021-03-10 mouth tingling, mouth numbness On March 3, 2021, a eligible vaccine recipient, patient, received her first dose of Pfizer Covid 19 ... Read more
On March 3, 2021, a eligible vaccine recipient, patient, received her first dose of Pfizer Covid 19 vaccine at approximately 9:00am. After a 15 minute observation period, patient was driving home at approximately 9:20am when she began to feel tingling and numbness in her mouth and tightening of the throat. Patient returned to clinic and informed clinic staff she was having a reaction to the vaccine. A cardiologist volunteering in the post-immunization observation met with the patient and evaluated her. The cardiologist was informed by patient that she had a history of allergic reactions to vaccines and carries an EpiPen, but had not used it yet. Patient's vitals were normal. She was given diphenhydramine for her symptoms, which did not improve. The Emergency Department was consulted, who advised that patient should be transported to the ED and monitored for 4 hours. The cardiologist transported patient to ED via wheelchair. The following day, patient reported she was released from the ED after 4 hours of observation. All of the symptoms had subsided at the time of release from the ED, and she was back to baseline on 3/4/21. The patient was referred to an allergist for consultation and clearance prior to receiving a second dose of Pfizer vaccine. Also of note, upon review of the patient's vaccine consent form, she did not acknowledge that she had previous anaphylactic reactions to other vaccines, nor was this information relayed to the vaccinator who administered the vaccine. Upon return to clinic, the patient reported she was 5-6 weeks pregnant.
39 2021-03-10 mouth tingling Tingling in lips and tongue. Raspy voice. Some shortness of breath and chest pain. Pt reported hx of... Read more
Tingling in lips and tongue. Raspy voice. Some shortness of breath and chest pain. Pt reported hx of asthma and pt took a breathing treatment of albuterol. No tongue swelling, rash, or airway closure reported.
39 2021-03-11 ear pain 3 days after--intense headache, throbbing head/neck heaviness--heavy to lift, pain behind ear, dizzi... Read more
3 days after--intense headache, throbbing head/neck heaviness--heavy to lift, pain behind ear, dizziness/lighthead/nausea 7 days after--treated for minor sinus infection--ear pain and dizziness etc were not related ENT said 10-14 days after- multiple cold-sores on face--potentially more coming
39 2021-03-11 eye swelling Staff member reported itchy throat, chest tighness, hoarse voice and swelling of neck area and eyes.... Read more
Staff member reported itchy throat, chest tighness, hoarse voice and swelling of neck area and eyes. On site physician was called, and staff member was evaluated. Pharmacist (myself) and director of nursing was present. Patient O2 sat was checked at 99% and BP noted to be 170/116. Staff member was able to swallow water and speak however recommendation made to call 911. EMT brought staff member to hospital where throat and chest tightness progressed. Staff member was given epinephrine, steroids and benadryl q6h and referred to her allergist.
39 2021-03-11 mouth swelling, mouth itchiness After about 18 minutes (patient under observation for 30 minutes) the patient started to complain of... Read more
After about 18 minutes (patient under observation for 30 minutes) the patient started to complain of itching on face, arms, and swelling feeling in mouth. she also c/o shortness of breath. On observation her oxygen saturation and blood pressure remained stable. she was brought into the office from the waiting area and given 25 mg benadryl IM. SHe was observed for 15 minutes and vitals were monitored and remained stable. she subsequently continued to have itching in throat and around mouth and hives were noted on arms and neck. her lips appeared starting to have edema. She was given one dose of epipen 0.3mg im in thigh and 911 was called. she was transported to er for further treatment and observation. she reported to us several hours later that she remained stable and was discharged on prednisone, famotidine, and cetirizine.
39 2021-03-11 oropharyngeal discomfort Patient c/o throat thickness. Osat 96%, BP 132/98, HR 72. Pt states she is back to baseline. S/S ... Read more
Patient c/o throat thickness. Osat 96%, BP 132/98, HR 72. Pt states she is back to baseline. S/S similar to GERD pt stated. Pt with in normal limits upon discharge.
39 2021-03-11 tongue disorder Receive 0.3 ml of Pfizer vaccine. Discovered later than vial had been diluted with 1.6 ml instead of... Read more
Receive 0.3 ml of Pfizer vaccine. Discovered later than vial had been diluted with 1.6 ml instead of the recommended 1.8 ml normal saline. Patient experienced Tingling/numbness on same arm as injection. Reports feeling odd. Observed and symptoms resolved within 20 minutes. Released home. Contacted 3/11/2021 and reports "Dizziness; cloudy headed feeling; feeling a lot better now but not completely back to normal; some bumps on her tongue that are improving; HR was elevated for remainder of day after "
39 2021-03-14 dry mouth Dizzy, Nauseous, Headache, Dry Mouth, Fatigue and barely able to walk... Weakness, Dehydration, Low... Read more
Dizzy, Nauseous, Headache, Dry Mouth, Fatigue and barely able to walk... Weakness, Dehydration, Low Magnesium at 1.6 and Sodium at 131 also High BP and a lowered pulse rate...
39 2021-03-14 ear pain Severe body aches and muscle aches. Jaw tension. Lymph nodes in neck swollen 72hrs later. Lung pain... Read more
Severe body aches and muscle aches. Jaw tension. Lymph nodes in neck swollen 72hrs later. Lung pain. Ear pain
39 2021-03-14 eye bleeding red blotch - broken blood vessel on white of right eye; This is a spontaneous report from a non-cont... Read more
red blotch - broken blood vessel on white of right eye; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El9266) on left arm, via an unspecified route of administration on 22Feb2021 18:00 at single dose for COVID-19 immunisation. Medical history included COVID from an unspecified date (if COVID prior vaccination: yes). The patient's concomitant medications were not reported. The patient experienced red blotch - broken blood vessel on white of right eye on 23Feb2021 07:00. The patient had no other vaccine in four weeks. The patient was not COVID tested post vaccination. There was no treatment received for the adverse event. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
39 2021-03-14 mouth numbness, lip swelling 12 minutes floowing vaccination (16:07) patient presents with swollen lips, hives on neck and compla... Read more
12 minutes floowing vaccination (16:07) patient presents with swollen lips, hives on neck and complaint of mouth numbness. Patient denied difficulty breathing, swollen throat or SOB. Pharmacist adminsted 25 mg diphenhydramine po at 16:08. Patient transferred to ED where she received Solumedrol 125 mg IV x1, Famotidine 20mg IV x1 and DIphenhydramine 25 mg IV x1. Patient stabilized and discharged home at 18:00.
39 2021-03-14 mouth tingling Per patient, at approximately 2pm patient received first pfizer vaccine for covid EN608 EXP 6/30/21 ... Read more
Per patient, at approximately 2pm patient received first pfizer vaccine for covid EN608 EXP 6/30/21 in her left deltoid muscle. Approximately, 10 mins. later patient c/o "tingling of lips and tip of tongue". Per patient use to have a "book" of numerous allergies, unable to recall all allergies this day. Stated she has "environmental and cat dander allergies". C/O of history of anxiety. Offered patient to send to hospital via ems for evaluation and higher level of care and refused. Patient signed refusal and it was witnessed. After symptoms resolved 30-45mins in EMS area, patient left in stable condition. This provider instructed patient to call her primary and obtain a clearance from primary to obtain send dose of covid vaccine in 3 weeks. Patient verbalized understanding.
39 2021-03-15 ringing in ears Tinnitus in right ear, sometimes shifts to left. Tinnitus has been constant since receiving the firs... Read more
Tinnitus in right ear, sometimes shifts to left. Tinnitus has been constant since receiving the first vaccine. It seems to be getting louder. Received 2nd vaccine dose on March 13th.
39 2021-03-16 feeling of choking Patient c/o throat tingling and was assessed by MD and prescribed Zyrtec 10 mg sublingually. Patient... Read more
Patient c/o throat tingling and was assessed by MD and prescribed Zyrtec 10 mg sublingually. Patient was observed for further 15 mins as recommended by MD. DC home at 1210.
39 2021-03-17 dry mouth, mouth discomfort the patient initially reported to the scheduler that she was having severe dizziness. at 1220 repor... Read more
the patient initially reported to the scheduler that she was having severe dizziness. at 1220 reports having mild lightheadedness, feeling hot, strange sensation in her mouth, dry mouth and foggy thinking. In addition, she admits to being apprehensive about receiving the vaccine. . BP 140/103 P is 100, Temp is 97.4 resp are 16. given water and placed in front of fan. at 1230 bp 140/96, pulse 100, Resp 16, O2sat 100%. At 1300 reports that she is feeling better and ready to leave if this RN feels it is ok for her to go. patient has partner waiting for her in parking lot. Discharged hom.
39 2021-03-18 deafness unilateral, ringing in ears some hearing loss in left ear; Ear ringing; This is a spontaneous report from a contactable other he... Read more
some hearing loss in left ear; Ear ringing; This is a spontaneous report from a contactable other health professional (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at the age of 39-years-old on 24Feb2021 18:00 (Lot Number: EL8982) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Feb2021 6:00 PM (Lot Number: unknown) as a single dose for COVID-19 immunization. The patient experienced some hearing loss in left ear (medically significant) and ear ringing on 03Mar2021 19:00. Unknown if patient received treatment. The outcome of the events was not recovered. The patient was not pregnant. Facility type vaccine was Hospital. No other vaccine in four weeks. No COVID prior vaccination. Not COVID tested post vaccination.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-03-18 drooling, mouth tingling 0945 Patient reported feeling nausea, lightheaded, dizzy, weakness in legs, and tingling in the left... Read more
0945 Patient reported feeling nausea, lightheaded, dizzy, weakness in legs, and tingling in the left side of her face that radiated down to the left lateral side of her neck. Upon assessment, patient noted to be visibly anxious. Patient reported that she has history of anxiety and has been anxious about shot for the past week. States "This is common when I become anxious, however, I have never felt tingling in my mouth and neck before." Also noted some drooling out the side of her left mouth. Patient vitals were BP: 136/90, O2: 100%, HR: 96. No visible signs of stroke with further assessment. After talking with patient and easing anxiety with relaxation techniques for 10 mins, all symptoms resolved. Patient feels she is going to be ok and doesn't want further treatment or intervention. Patient walked out clinic at 1010 with no further issues.
39 2021-03-18 lip swelling I received my second vaccine on 3/19 at 5:45pm. At 7pm the same day, my right lip began to swell up... Read more
I received my second vaccine on 3/19 at 5:45pm. At 7pm the same day, my right lip began to swell up and my right side of my face feels tingly
39 2021-03-18 ringing in ears, mouth numbness, mouth tingling, visual impairment, drooping eyelid Debilitating headache; nausea; vomiting; ringing in the ears; L eye drooping; numbness and tingling ... Read more
Debilitating headache; nausea; vomiting; ringing in the ears; L eye drooping; numbness and tingling of lips; numbness and tingling of lips; trembling of R side of body; abnormal/change in gait; change in vision; hypertension; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number and Expiration date was unknown), first dose via an unspecified route of administration on an unspecified date, second dose via intramuscularly in right arm on 16Jan2021 15:30; both at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included depression, MTHFR (methylenetetrahydrofolate reductase), latex allergy. Concomitant medications included venlafaxine, L-methylfolate; the patient received both the drugs within 2 weeks of vaccination. The patient previously took fluoxetine, citalopram and experienced known allergies for both the drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient experienced debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension on 25Jan2021 06:00. On 01Feb2021, the patient underwent lab test and procedure included nasal swab/ COVID-19 by PCR: Negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with IV Dexamethazone, Diphenhydramine, ketorolac, promethazine for all the events. The outcome of the events was not recovered. Information on the Lot/Batch number has been requested.; Sender's Comments: On the basis of the available information, the reported events debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension would seem most likely related to intercurrent and/or underlying medical condition and concomitant medication, which is not related to bnt162b2. This case will be reassessed when additional information becomes available. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-03-19 ringing in ears Sudden onset of ringing in my right ear, so far lasting for about five minutes (still going)
39 2021-03-20 swollen tongue throat sratchy, tongue swelling, nausea, dizziness
39 2021-03-20 swollen tongue FOLLOWING ADMINISTRATION OF PFIZER VACCINE PT DEVELOPED SWOLLEN TONGUE. HX MULTIPLE ALLERGIES AND MU... Read more
FOLLOWING ADMINISTRATION OF PFIZER VACCINE PT DEVELOPED SWOLLEN TONGUE. HX MULTIPLE ALLERGIES AND MULITPLE INCIDENTS OF ANAPHYLAXIS. CARRIED EPIPEN. EPI-AUTO INJECTOR 0.3MG IM X 1. TRANSFERRED TO HOSPITAL ED IN THE BUILDING FOR EMERGENCY MEDICAL ASSESSMENT. NO SOB OR DIFFICULTY BREATHING. NO ITCHING OR RASH. PT CALM.
39 2021-03-20 vision blurred At exact time of infection, whole left arm started getting tingly and warm, especially from crook ... Read more
At exact time of infection, whole left arm started getting tingly and warm, especially from crook of elbow down through fingers. My usual comfortable watch felt tight and annoying. Was able to walk to observation area, then started getting dizzy and light- headed. Still had warm, tingly feeling in arm that received injection. My normal resting heart rate is 61 but now it was up to 111 per smart watch (possibly 121 but can't confirm since I was dizzy and blurry-eyed). In addition to tingly arm, racing heart, dizziness, I felt immediate fatigue and wanted to lay down and sleep. Also, had dull headache on left-side. Nurse sat me down and elevated my feet. Also got me some frozen peas for my forehead and neck. After 12-13 mintues, I started feeling better. She kept me under observation for full hour. Got better and went home. Heart rate remained elevated at 78-89 rest of evening. Dull headache remained on left- side only. Similar feeling to when wearing a tight pony tail and you take it out.
39 2021-03-21 eye itchiness INITIALLY FELT AN ITCHING NEAR HER FOREHEAD/EYES. NO S/S OF ANGIOEDEMA. NO SOB, NO SCRATCHY THROAT. ... Read more
INITIALLY FELT AN ITCHING NEAR HER FOREHEAD/EYES. NO S/S OF ANGIOEDEMA. NO SOB, NO SCRATCHY THROAT. BLOOD PRESSURE AND HEART RATE ELEVATED. AFTER INITIAL ANXIETY OVER POSSIBLE REACTION, HER HEART RATE WAS DECREASED BUT BP REMAINED IN HYPERTENSIVE URGENCY RANGE.
39 2021-03-21 ringing in ears Day 1: high heart rate for about 12 hours after injection - would not go below 100 even lying down; ... Read more
Day 1: high heart rate for about 12 hours after injection - would not go below 100 even lying down; warm flushing feeling randomly through body. Chills and fatigue 2 hours after shot. Day 2: arm sore; as day went on got achy all the way down to rest. heart rate back to normal but still high when walking. Very fatigued - head pressure Day 3: Still fatigued; heart rate normalized - no appetite, some stomach discomfort and head pressure Day 4: Fatigue, stomach discomfort and achy joints down left side of body - still have head pressure Day 5: Low fever of 99, ear canals swollen and waves of nausea; head pressure; ear ringing Day 6: Fatigue is gone, aches are gone and ear canals/pressure/ringing seem to be getting better. Day 11: Off and on stomach distress
39 2021-03-21 tongue disorder Pt waiting after vaccination. At about 30 minute mark pt reported throat itching. nurse monitored pt... Read more
Pt waiting after vaccination. At about 30 minute mark pt reported throat itching. nurse monitored pt. Symptoms progressed to throat clearing/cough. Epinephrine administered. Benadryl administered IM. Ambulance called. While waiting for ambulance pt reported feeling tongue thickness. @nd dose of epinephrine given while awaiting ambulance. Paramedics evaluated pt and advised ER. pt refused. Advised pt to seek medical attention for any new/worsening symptoms. Advised pt not to drive home but have someone else take her home and to not be alone. pt daughter came to clinic and nurse witnessed pt enter vehicle.
39 2021-03-22 ringing in ears, deafness Woke up the morning of 1/28 unable to hear any sound out of left ear, gradually possibly gaining hea... Read more
Woke up the morning of 1/28 unable to hear any sound out of left ear, gradually possibly gaining hearing back however there's a constant ringing in left ear still concurrent as of today's date 3/23 (almost 2 months of on-set symptoms)
39 2021-03-22 tongue discomfort Tongue feels "weird" and throat is tight. Placed on oxygen and provided 25 mg Benadryl. BP 147/71 HR... Read more
Tongue feels "weird" and throat is tight. Placed on oxygen and provided 25 mg Benadryl. BP 147/71 HR 113
39 2021-03-23 enlarged tonsils Systemic: throat/tonsils slightly swollen-Mild
39 2021-03-23 vision blurred Feeling tightness on the face for around 45 min. Blurred vision, very dizzy and unable to have good ... Read more
Feeling tightness on the face for around 45 min. Blurred vision, very dizzy and unable to have good balance for 6 days.
39 2021-03-24 mouth numbness Mild numbness of upper and lower lips and the tip of my tongue starting about 30 minutes after and l... Read more
Mild numbness of upper and lower lips and the tip of my tongue starting about 30 minutes after and lasting only about 2hrs after the first vaccine, self resolved. Left sided auricular, axillary, and cervical lymphadenopathy noticed about 1 week after the first vaccine. Still present
39 2021-03-24 lip swelling Patient experienced lip swelling post vaccine #1, which resolved with 50 mg oral Benadryl administer... Read more
Patient experienced lip swelling post vaccine #1, which resolved with 50 mg oral Benadryl administered by EMS standing by. No transportation to hospital needed. Today at vaccine #2 she experienced a cough, and was assessed by EMS. Per EMS no adventitious breath sounds noted, no wheezing and no concern with PS02 sats. 50 mg Benadryl administered today. and she reported relief felt. Patient stated that she was in contact with her oncologist who "wasn't crazy about me getting the shot," but "he said it was up to me." No transportation needed.
39 2021-03-24 vision blurred The vision in my right was blurred for about 6 hours. When it started to get better it was inconsist... Read more
The vision in my right was blurred for about 6 hours. When it started to get better it was inconsistent. I would close my left eye and at first my right eye would be blurry for about 2-3 seconds then would be able to focus. As of now 13 hours after first noticing the problem upon waking, my vision is almost 20/20 again from what I can tell not having a doctors visit.
39 2021-03-25 oropharyngeal discomfort About 45 minutes post vaccine my chest, neck, and face started to turn bright red and I had a horrib... Read more
About 45 minutes post vaccine my chest, neck, and face started to turn bright red and I had a horrible burning sensation as well as a scratchy throat. I went to a walk in minor care clinic and they gave me a steroid shot. The following day around 11:00 am the reaction spiked again and I went to the ER. While at the ER they gave me more steroids, benadryl, and pepcid and observed the reaction for a couple hours. The redness got better and the burning subsided but my skin was still a pinkish tone. Today, the third day, I have a tingling feeling in my skin where the reactions occurred and they are bright pink. I am on oral steroids and pepcid for a week.
39 2021-03-25 mouth tingling, mouth discomfort Pt received Covid-1 vaccine. About 15 minutes after shot was given pt waved down parking attendant a... Read more
Pt received Covid-1 vaccine. About 15 minutes after shot was given pt waved down parking attendant and asked for a nurse. 2 nurses arrived at pt's car. Pt reported that she first started feeling itchy on a bug bite on her arm which was red. She then stated it went from her bug bite to feeling tingly/burning on her lips. Pt reported she hadn't eaten much today and had drank hardly any water today. Pt's vitals were 152/92 to which pt stated she takes BP meds and her BP is at times higher than that. Her HR was 64, resp 22, SpO2 98%. Pt stayed for an extra 15 minutes then stated she was feeling better and wanted to go home.
39 2021-03-25 visual impairment Approximately 45 after injection a migraine began with visual disturbance. Wavy lines across field o... Read more
Approximately 45 after injection a migraine began with visual disturbance. Wavy lines across field of vision obscuring eyesight. This was accompanied by fatigue. That night racing thoughts throughout the night. I felt as if I was awake all night cataloging my daily life. The following day only sore muscles and muscle weakness in left arm.
39 2021-03-26 taste impairment 10 minutes after receiving covid vaccine, rapid heart rate, hard to breathe, and metallic taste in ... Read more
10 minutes after receiving covid vaccine, rapid heart rate, hard to breathe, and metallic taste in mouth. Advised to go to emergency after been checked out by allergist on site. At emergency, was given Pepcid, steroids, IV fluids, Benadryl intravenously. Also, did bloodwork and chest X-ray. After bloodwork came back, doctor felt okay to release me. Over the week, still felt heavy chested and I could not return to work until a week later. The emergency doctor, sent me home with steroids, Pepcid, and Benadryl to take for the next 3 days. I only took the steroids and Pepcid because the Benadryl made me feel so out of it. I also started to get fatigued couple days after with some body aches. On Saturday morning, I woke up at 4:00 am to vomit. Had an appointment with my PCP that Monday, told me to take Claritin and Albuetrol inhaler.
39 2021-03-27 pain in jaw, ear discomfort neck and jaw pain; neck and jaw pain; has clicking in her jaw; concerned these symptoms following v... Read more
neck and jaw pain; neck and jaw pain; has clicking in her jaw; concerned these symptoms following vaccine could be Bell's Palsy/Palsy; dull ear; She stated she could not walk on her left foot on 11Mar2021 but recovered the next day; This is a spontaneous report from a contactable consumer (the patient). This 39-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EN6204), via an unspecified route of administration, in the right arm on 10Mar2021 at 10:45 AM (at the age of 39 years) as a single dose for COVID-19 immunization. Medical history included skin wrinkling. Concomitant medication taken within two weeks of vaccination included botulinum toxin type a (BOTOX) taken for skin wrinkling, and unspecified birth control pills. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot # EN6200, on 18Feb2021, in the right arm COVID-19 immunization, and experienced fatigue. The patient reported that while she was sleeping last night on 11Mar2021 around 02:00-3:00, she had onset of dull ear, neck and jaw pain on left side. She had clicking in her jaw. The patient mentioned she never had a droopy face. She stated she could not walk on her left foot on 11Mar2021 but recovered the next day. She's concerned these symptoms following vaccine could be Bell's Palsy - what should I do. She looked online and saw that these are some of the first symptoms of Bell's palsy. She called to ask if these events could be Bell's palsy, and for information on events and Bell's palsy relative to the COVID-19 Vaccine. She informed that she had an upcoming appointment with her doctor "today" at 14:00 to see if she has Bell's palsy. The patient stated she went to the doctor on 11Mar2021 at 03:00 pm. Event term of Palsy with onset date of 11Mar2021 was reported. The physician did not prescribe medication, no treatment given. The clinical outcome of dull ear, neck and jaw pain, has clicking in her jaw, and palsy was recovered on 13Mar2021
39 2021-03-27 sensitivity to light Fever, chills, headache, nausea, vomiting, dizziness like I was going to pass out. Sensitive to lig... Read more
Fever, chills, headache, nausea, vomiting, dizziness like I was going to pass out. Sensitive to lightens arm pain near injection sight.
39 2021-03-29 mouth numbness After administration, pt presented with itchy/ numb tongue . Patient took benadryl first , after ... Read more
After administration, pt presented with itchy/ numb tongue . Patient took benadryl first , after 40 minutes, patient complained of trouble swallowing. At this time, an ambulance was called to evaluate the patient for anaphylaxis. She was fine after an hour and EMT sent patient home.
39 2021-03-30 taste impairment Metallic taste in my mouth; Mild face swelling; This is a spontaneous report from a non-contactable ... Read more
Metallic taste in my mouth; Mild face swelling; This is a spontaneous report from a non-contactable other health care professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number: EL9265 Exp Date:not reported),via an unknown route of administration in right arm (at the age of 39-year-old) on 27Jan2021 at 4pm at a single dose for COVID-19 immunization. Medical history included asthma, obesity and post-traumatic stress disorder, all from an unknown date and unknown if ongoing. Patient has allergies with bee stings from unknown date and unknown if ongoing. It was also reported that prior to vaccination, the patient was not diagnosed with COVID-19. Patient was also reported not to be pregnant at the time of vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and ibuprofen (MOTRIN), both taken for an unspecified indication and start and stop date were not reported. Patient previously received Hepatitis A vaccine and had allergies. The patient experienced mild face swelling at 4:45pm (about 45 minutes after injection, as reported) then she had a metallic taste in her mouth that started about 6:30pm (about 2.5 hours after injection) and lasted until about 8 pm. She reported that she could still taste the food. Patient has not been tested for COVID-19 since vaccination. The outcome of mild face swelling was recovered on an unknown date while metallic taste recovered on 27Jan2021 at 8pm. No follow-up attempts are possible; information about lot/batch number already obtained
39 2021-03-30 mouth tingling My heart rate was around 115/120. Heart rate still elevated even now nearly 10 hrs later; my lips an... Read more
My heart rate was around 115/120. Heart rate still elevated even now nearly 10 hrs later; my lips and in my mouth was tingly; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 39-year-old via an unspecified route of administration, administered in Arm Left on 16Mar2021 09:00 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included Asthma, high blood pressure, anxiety, allergies: Peanuts, tree nuts, cantaloupe, watermelon, imitrex. Concomitant medications included sertraline hydrochloride (ZOLOFT); amlodipine besilate (NORVASC); budesonide, formoterol fumarate (SYMBICORT); salbutamol sulfate (ALBUTEROL). The patient previously took first dose of BNT162B2 at the age of 39-year-old in Left arm on 23Feb2021 10:15 for covid-19 immunisation, lot number=EN6203. There were no covid prior vaccination, no other vaccine in four weeks, and no covid tested post vaccination. About 10 mins after vaccine the area around patient's lips and in her mouth was tingly. The patient's heart rate was around 115/120. Heart rate still elevated even now nearly 10 hrs later. Called Her primary dr. He sent patient to ER. The event onset date and time were 16Mar2021 09:30. Treatments were received including IV Fluids, Ativan. The events outcome was Not recovered.
39 2021-03-30 light flashes or floaters in the eye First dose 1/30/2021 within one hour became extremely fatigued, lasting 12-16 hours. Fatigue in week... Read more
First dose 1/30/2021 within one hour became extremely fatigued, lasting 12-16 hours. Fatigue in weeks to follow. Second dose 02/20/2021, 12 hours to follow, extreme muscle pain all over body, seeing flashing lights in eyes and headache. Major body chills and fatigue. Difficulty walking without holding on to wall or doors. Extreme fatigue to follow, on and off, current fatigue.
39 2021-03-30 swollen tongue, mouth tingling 30 minutes following injection the patient began experiencing tingling of the lips and sensation of ... Read more
30 minutes following injection the patient began experiencing tingling of the lips and sensation of swollen tongue. no shortness of breath, wheezing, chest tightness, lightheadedness or syncope. She was given 25 mg po Benadryl and monitored for 45 minutes. her symptoms resolved completely.
39 2021-03-31 taste impairment Metallic taste in mouth immediately after vaccine was administered.
39 2021-03-31 mouth swelling, eye swelling, swollen tongue Anaphylaxis; swelling of face, eyes, mouth, tongue.; swelling of face, eyes, mouth, tongue.; swellin... Read more
Anaphylaxis; swelling of face, eyes, mouth, tongue.; swelling of face, eyes, mouth, tongue.; swelling of face, eyes, mouth, tongue.; swelling of face, eyes, mouth, tongue.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6205), via an unspecified route of administration on 05Mar2021 08:45 (at the age of 39-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included possible Covid one year ago (in 2020) and known allergies: mild shellfish allergy. Concomitant medication included ibuprofen in two weeks. On 05Mar2021 at 16:00, the patient experienced anaphylaxis, swelling of face, eyes, mouth, tongue that resulted in emergency room/department or urgent care. Treatment included epinephrine, steroids and diphenhydramine hydrochloride (BENADRYL). It was unknown if with covid prior vaccination. Not covid tested post vaccination. The patient had no other vaccine in four weeks. The outcome of the events was recovered in Mar2021.
39 2021-03-31 thirst 3/26- Thirst 3/27- Achy especially joints, chills with no fever, tired 3/28- Same as 3/27 with sever... Read more
3/26- Thirst 3/27- Achy especially joints, chills with no fever, tired 3/28- Same as 3/27 with severe diarrhea and nausea 3/29-Fine 3/30-Fine 3/31- Return of all symptoms from 3/27 4/1- Woke up covered in sweat, still no fever, symptoms from previous day gone
39 2021-03-31 ringing in ears Developed severe and persistent tinnitus approximately one week after first injection. Did not have ... Read more
Developed severe and persistent tinnitus approximately one week after first injection. Did not have any tinnitus before vaccine. Tinnitus present in both ears but worse in left ear. No other side effects except for sore arm and fatigue.
39 2021-03-31 tongue disorder, swollen tongue, burning mouth syndrome tongue was swollen/The front half of her tongue was swollen and stinging; tongue was swollen and had... Read more
tongue was swollen/The front half of her tongue was swollen and stinging; tongue was swollen and had white dots and a sore tip on the tongue. The front half of her tongue was swollen and stinging; had white dots and a sore tip on the tongue; Sinus Pressure; Body Aches; Tired; Dizzy; Nausea; This is a spontaneous report from a contactable licensed practical nurse (LPN) reporting on behalf of physician. A 39-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on 09Mar2021, at 39 years of age, (Batch/Lot Number: EN6206) as single dose for COVID-19 immunization. The patient had no medical history; concomitant medications were not reported. On 09Mar2021, a few minutes after receiving the vaccine, the patient felt sinus pressure that lasted the rest of the day, she was tired and dizzy for two days and also had nausea for two days and body aches for the first 3 days, all assessed as non-serious. Then the patient stated that when she woke up on 11Mar2021, her tongue was swollen and had white dots and a sore tip on the tongue. The front half of her tongue was swollen and stinging. The patient stated she did not feel as if though her throat was swollen, just her tongue, but it resolved after 3 days. These events were assessed as medically significant and the tongue swelling was what the reporter was mainly concerned about. There were no treatments, no medication was given, the patient was not seen in the Emergency Department, she was not hospitalized and was not admitted to an Intensive Care Unit. She visited the Physician Office on 15Mar2021 and Physician Assistant advised the patient not to get the second COVID vaccine. The event "sinus pressure" resolved on 09Mar2021, the events "Tired", "Dizzy" and "Nausea" resolved on 11Mar2021, the event "body aches" resolved on 12Mar2021, the events "tongue was swollen and had white dots and a sore tip on the tongue; the front half of her tongue was swollen and stinging" resolved on 14Mar2021.; Sender's Comments: Based on the information available, a causal association between BNT162B2 and the reported serious events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
39 2021-04-01 taste impairment, thirst The day I received the vaccine, I noticed that I feel thirsty later in the day. I didn't really take... Read more
The day I received the vaccine, I noticed that I feel thirsty later in the day. I didn't really take much into it and it seemed to be ok the next couple days. 5 days later, I woke up to extreme thirst and a very salty taste in my mouth. This continued until the day after two weeks after receiving the 2nd dose. It has now gone away so I think it was related. My doctor ran my AIC (fasting and not) the first week and several blood work on electrolytes, thyroid etc. Everything was normal and my blood sugar is controlled (as it was before the vaccine). I also had COVID in December (a mild case) and recovered fully. I also noted my urine was yellow (not scary, hospital) yellow but dark. No matter how much water I drank, it did not change. I also drank Gatorade etc. and that didn't change anything. After receiving the 2nd dose, two weeks later is when I noticed it start to be a little better and then two more days later, it went away.
39 2021-04-01 oropharyngeal discomfort Throat fullness/tightness, heart racing, hot feeling, chest tightness and wheezing approximately 26 ... Read more
Throat fullness/tightness, heart racing, hot feeling, chest tightness and wheezing approximately 26 to 27 minutes or so after the vaccine
39 2021-04-01 sensitivity to light Received first shot of COVID 19. Felt fine until 4 hours after. Migraine like symptoms with chills... Read more
Received first shot of COVID 19. Felt fine until 4 hours after. Migraine like symptoms with chills and shaking and nausea. Driving home and had photophobia and aura like vision. Took Tylenol and tried to sleep. Woke up today and felt ok.
39 2021-04-01 ringing in ears Ten days after the vaccine I started having involuntary twitching of my arms and legs . It was bilat... Read more
Ten days after the vaccine I started having involuntary twitching of my arms and legs . It was bilateral, a single twitch every ten minutes or so all day long. I am still having the twitching in my arms and legs hourly after 11 weeks. I also have insomnia nightly, a brief waking one or two times a night also still happening after 11 weeks. My left ear had a crackling sound that came and went a couple of times a day. which is now happening a couple of times weekly. Starting on day 14 I had severe breast pain for three days. I have been trying multiple forms of naturopathic treatment to help and the symptoms have improved slightly. I plan to see a Neurologist.
39 2021-04-01 eye floaters, mouth numbness, pain in jaw, mouth tingling The first abnormal effect I experienced was numbness in my inner upper lip. This was intermittent an... Read more
The first abnormal effect I experienced was numbness in my inner upper lip. This was intermittent and lasted roughly 24-48 hours after vaccine administration. Then on 3/25, I had muscle cramping/soreness in my lower leg muscles (calves). The next day (3/26), the muscle soreness continued, and my lower leg muscles began to feel tight when walking. On 3/27, I woke up with numbness and tingling in my right 5th digit, which then spread to all my fingers and toes. That morning, the muscle soreness had also spread into my thighs and bilateral upper extremities. I also noted mild swelling in my hands and feet and could not put my rings on or wear socks or shoes. By that evening, walking became more difficult as the muscle soreness had now turned into muscle weakness. This prompted me to go the ER for evaluation. A CT scan of my head and lab work was done. I was given IV fluids and sent home with instructions to return to the ER the following day for a MRI of my brain. Overnight, the weakness and swelling in my hands and feet progressed . I became unable to walk, go to the bathroom, or feed my self without assistance. The numbness and tingling I first experienced in my inner upper lip returned, and these symptoms were also now noted in the rest of my face as well. I also began having muscle soreness in my neck, my jaw felt sore when chewing food, and I began seeing some floaters. I returned to the ER the morning of 3/28. They did more blood work, imaging, as well as a lumbar puncture, and I was admitted to hospital. Once admitted, the hospitalist consulted with another hospital and recommended transfer by EMS there where I was admitted under a neurologist's care. When I arrived at that hospital, I began to feel somewhat better as the soreness and swelling appeared to be improving, and I could walk without assistance. They did a full neurological workup and kept me overnight for observation. Overnight, I did experience a mild headache that was relieved with Tylenol and rest. I woke up the next morning (3/29) with nausea and did have a few episodes of vomiting that turned into dry heaving and was given Zofran with relief. The swelling in my hand went down enough that I was able to make a fist and grasp objects with my fingers again. After the neurologist reviewed my labs and work up the morning of 3/29, I was allowed to return home to await final test results as all my tests were looking normal, my symptoms were continuing to improve, and PT had cleared me to be able to return home. Upon discharge, I was instructed to not get my 2nd COVID vaccination as it was possible that my symptoms were an adverse reaction to the COVID vaccination as no other diagnosis was found with testing. I was instructed to follow up with my PCP in one week. Since returning home, I have continued to be very easily fatigued and have had some headaches, nausea, and dizziness. I continue to feel weak when walking and have some muscle stiffness when first waking from sleep. I also continue to have some intermittent episodes of numbness and tingling.
39 2021-04-02 deafness, ringing in ears I have never had a history of hearing loss or ringing in my ears. Within 1 week of receiving my firs... Read more
I have never had a history of hearing loss or ringing in my ears. Within 1 week of receiving my first dose of the COVID vaccine, I began experiencing horrible tinnitus, dizziness and nausea.
39 2021-04-02 ear congestion, ringing in ears Ear congestion, ear ringing, fatigue, arm pain
39 2021-04-02 mouth ulceration, dry mouth, feeling of choking, taste impairment Within first 10 minutes Metallic taste Tingly feeling in throat & mouth Hives Within 15 minutes... Read more
Within first 10 minutes Metallic taste Tingly feeling in throat & mouth Hives Within 15 minutes -Took Benedryl - checking in at ER Felt dizzy (low blood pressure) Felt as though I was about to pass out Mental confusion, foggy brain Extremely dry mouth Within 20 minutes - treated with more Benedryl, Pepcid, and a steroid Tightening in the chest Chest pain Oxygen saturation 80% for approximately 10 minutes. Oxygen saturation 92% for approximately the next hour. Palms of my hands were blue. By 6:20pm I was released from the hospital. Most symptoms were resolved. My chest was still tight and I started a mild cough. I used my rescue inhaler at 8:00pm and that provided some relief.
39 2021-04-02 swollen tongue Right after vaccination, patient felt itching, flushing, sweeling of skin/tongue, throat tightness, ... Read more
Right after vaccination, patient felt itching, flushing, sweeling of skin/tongue, throat tightness, nausea, anxiety, sweating, and difficulty swallowing. (BP 180/100 HR 96) Patient took 25mg of benadryl and was seated for monitor about 30 min until symptoms were improved.
39 2021-04-02 ringing in ears Tinnitus, started after shot and has been getting louder, it has been 3 days so far
39 2021-04-04 loss of taste, loss of smell Patient tested positive for COVID-19 after completing the full Pfizer vaccine series, 65 days after ... Read more
Patient tested positive for COVID-19 after completing the full Pfizer vaccine series, 65 days after 2nd dose. Patient received 2nd dose of COVID vaccine on 1/19/21 . Tested positive on 3/25/21. NOT hospitalized. My son was sent home from school due to exposure with a positive COVID classmate. My husband then tested positive the following day. "nasal congestion, runny nose, headache, new loss of taste/smell symptom onset date: 3/25/2021"
39 2021-04-04 mouth numbness, lip itchiness Pt received shot at 1626. At 1637, pt reported that her lower lip felt itchy, cheeks were red. Pt ha... Read more
Pt received shot at 1626. At 1637, pt reported that her lower lip felt itchy, cheeks were red. Pt has hx anaphylaxis to multiple food allergies and carries epi pen with her. At 1638, VS: BP 168/112, P 86, O2 100% RA.Lungs clear bilaterally. Pt then reported that her tongue felt ?numb? and ?pins and needles? sensations. Recheck BP is 200/130 at 1644. Pt is awake, alert, oriented. She states that when she has anaphylaxis in the past, this is how it initially presents. Dr. called at 1645 and notified of pt condition and advises to give epi and benadryl and call ems. EMS called at 1650 by RN. Pt requested to wait until EMS is closer to take epi as she said that it can make her blood pressure raise. At 1653, pt willing to take epi. Pt?s seat reclined. Epi pen 0.3mg given at 1653, Benadryl 50mg liquid given at 1654 by RN. EMS on site to take over care at 1655. Pt remains A&OX4 at this time. No difficulty breathing at this time. Pt remains fully conscious. Pt transferred to hospital in EMS. Pt notified that due to her having anaphylactic reaction to vaccine, she will not be able to receive another vaccine. Pt advised to follow up with PCP. RN
39 2021-04-04 lip swelling Full body rash and hives, incredibly itchy. Bottom lip swelled up. Had to go to urgent care. Receive... Read more
Full body rash and hives, incredibly itchy. Bottom lip swelled up. Had to go to urgent care. Received steroid and benadryl shot. Got a steroid prescription.. Rash came back at 2am. Went to Dr's office. They recommended taking zyrtec and peocid ac every morning and night. Rash keeps coming back in different locations. Dr is performing bloodwork. My second vaccine is appt is 04.10 need to know if I should still go or reschedule. I've never had an allergic reaction, rash or hives before.
39 2021-04-05 lacrimation increased Light headed, runny nose, sore throat, tiredness, watery eyes. Started to get a sore throat about 11... Read more
Light headed, runny nose, sore throat, tiredness, watery eyes. Started to get a sore throat about 11 pm on 4/5 and by the time I woke up at about 6:30 am on 4/6 turned into "cold-like" symptoms. Seems to be getting worse throughout the day.
39 2021-04-06 swollen tongue This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female pat... Read more
This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 20Mar2021 08:30 as a single dose for COVID-19 immunisation. Medical history included cystitis interstitial and allergies: cat and bee stings. Concomitant medications included prednisone epinephrine, and chlorphenamine maleate (ANTIHISTAMIN) taken. Patient was not pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID prior to vaccination. After about 30 minutes, on 20Mar2021 09:00 AM, the patient experienced tongue started swelling and would not subside. She tried antihistamine all day with no success. She went to Urgent Care and received steroid shot and was prescribed prednisone that same evening. She was told to return if symptoms not improved in three days. The patient returned on Monday evening and was sent to the ER. She was diagnosed with Angioedema and given more antihistamines and steroid shot and epinephrine in IV. The patient was currently monitoring and seeing an allergist to follow up. Her tongue was still not back to normal. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of tongue started swelling and would not subside was not recovered, and of angioedema was unknown. The events were reported as non-serious. The patient had not been been tested for COVID-19 since the vaccination. No follow-up attempts are possible; information on the batch/lot number cannot be obtained.
39 2021-04-06 ringing in ears constant ringing in ears, tinnitus
39 2021-04-06 ringing in ears Constant Tinnitus
39 2021-04-07 eye pain In addition to the known side effects of fever, chills, body aches, headaches, and brain fog, my men... Read more
In addition to the known side effects of fever, chills, body aches, headaches, and brain fog, my menstrual cycle occurred about 10 days post what it should have started in February. In March menstrual cycled started about 5 days later than in February. On April 3, 2021 started to have eye pain, was diagnosed with a chalazion cyst on April 7. Cyst is on the eyelid of left eye. I have never had issues with cysts or swelling of any kind.
39 2021-04-07 mouth numbness Lip/perioral numbness 3 minutes after
39 2021-04-07 feeling of choking Pt reported to post vaccination waiting area as instructed after vaccine administration. Pt began to... Read more
Pt reported to post vaccination waiting area as instructed after vaccine administration. Pt began to feel "dizzy" and notified staff. While with patient, pt started to have tightness in chest, difficulty breathing. tingling in throat, and "tight airway". Vitals signs were obtain at 1400 178/110. At 1402 EPI 0.3 mg given in the Right Thigh and 1405 50 mg Benadryl IM to Left deltoid. After EPI administration vitals were obtained, 1406 148/82, SpO2 99%, HR 95. Vitals at 1409 164/100 HR 118 SpO2 98%. EMS was called at 1357 and arrived to site at 1410.
39 2021-04-07 vision blurred fever, chills, fatigue, blurry vision (onset evening of vaccine), L arm/hand numbness
39 2021-04-08 ear pain, ear discomfort I am having an earache in my left ear (same side vaccine was administered), and it feels like I have... Read more
I am having an earache in my left ear (same side vaccine was administered), and it feels like I have something clogged in my ear canal. Hurts to push on my ear hole.
39 2021-04-08 lip itchiness, tongue itchiness, mouth itchiness, eye itchiness Flushed face, itchy lips, tounge, roof of mouth, and head. EMT checked and advised Benadryl. Took ... Read more
Flushed face, itchy lips, tounge, roof of mouth, and head. EMT checked and advised Benadryl. Took benadryl at 10:54am symptoms continued to progress itchy eyes, began to feel tighness in throat and chest but benadryl began working. Still was itchy and flushed but not as bad. Around 4pm began to feel lightheaded and dizzy, eyes and face itchy. Felt like throat was blocked and like i was going to faint. Took more benadryl and went to er because I was having problems breathing. Was given steroids and pepsid. Placed on a course of benadryl, pepsid and steroids for the next 5 days instructed to follow up with PCP in 2 days.
39 2021-04-08 thirst, mouth tingling Within ten minutes of receiving shot: Flush, felt hot Lips tingling Trouble swallowing Shaky Rea... Read more
Within ten minutes of receiving shot: Flush, felt hot Lips tingling Trouble swallowing Shaky Really thirsty Dizzy
39 2021-04-09 loss of taste Headache on the right side of the head, tingling on the right side of the face, facial paralysis, lo... Read more
Headache on the right side of the head, tingling on the right side of the face, facial paralysis, loss of sense of taste,
39 2021-04-09 inability to speak Loss of voice and tightness in my chest and ribs.
39 2021-04-09 taste impairment Immediately after vaccination an overpowering metallic taste was present in my mouth; This is a spon... Read more
Immediately after vaccination an overpowering metallic taste was present in my mouth; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, at the age of 39 years, administered in Arm Left on 27Mar2021 12:45 (Lot Number: EP6955) at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. No Allergies to medications, food, or other products. Reported that Immediately after vaccination an overpowering metallic taste was present in my mouth. Even after eating, drinking and brushing teeth the taste remained. Food and drink still tasted the same but immediately after swallowing my mouth tasted like I was sucking on a roll of pennies. By the following morning it was gone on 28Mar2021. Adverse event started on 27Mar2021 12:45. No treatment received for the adverse event. Outcome of events was recovered on 28Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
39 2021-04-09 hearing loss, eye itchiness, ear itchiness decreased hearing; Allergic reaction which included hives; Mild vasovagal reaction; itchy throat; Al... Read more
decreased hearing; Allergic reaction which included hives; Mild vasovagal reaction; itchy throat; Allergic reaction which included hives, itchy throat, eyes, nose, and ears, and hives; fast heart rate; flushing; lightheaded; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; This is a spontaneous report from a contactable other HCP (patient). A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 39-year-old via an unspecified route of administration, administered in Arm Left on 26Mar2021 17:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthma, allergies, inflammatory bowel disease. There was no COVID prior vaccination, no other vaccine within 4 weeks prior to the COVID vaccine, and no COVID tested post vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); lisdexamfetamine mesilate (VYVANSE); breo all within 2 weeks of vaccination. The patient experienced allergic reaction which included hives, itchy throat, eyes, nose, and ears; mild vasovagal reaction which included flushing, fast heart rate, lightheaded, and decreased hearing all on 26Mar2021 17:15 and resulted in Doctor or other healthcare professional office/clinic visit. Treatments included antihistamines and steroids. The events outcome was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the contributory role of the suspect product is possible.
39 2021-04-10 mouth numbness, lip itchiness Pt received shot at 1626. At 1637, pt reported that her lower lip felt itchy, cheeks were red. Pt ha... Read more
Pt received shot at 1626. At 1637, pt reported that her lower lip felt itchy, cheeks were red. Pt has hx anaphylaxis to multiple food allergies and carries epi pen with her. At 1638, VS: BP 168/112, P 86, O2 100% RA.Lungs clear bilaterally. Pt then reported that her tongue felt ?numb? and ?pins and needles? sensations. Recheck BP is 200/130 at 1644. Pt is awake, alert, oriented. She states that when she has anaphylaxis in the past, this is how it initially presents. Dr called at 1645 and notified of pt condition and advises to give epi and benadryl and call ems. EMS called at 1650 by RN. Pt requested to wait until EMS is closer to take epi as she said that it can make her blood pressure raise. At 1653, pt willing to take epi. Pt?s seat reclined. Epi pen 0.3mg given at 1653, Benadryl 50mg liquid given at 1654 by RN. EMS on site to take over care at 1655. Pt remains A&OX4 at this time. No difficulty breathing at this time. Pt remains fully conscious. Pt transferred to hospital in EMS. Pt notified that due to her having anaphylactic reaction to vaccine, she will not be able to receive another vaccine. Pt advised to follow up with PCP.
39 2021-04-11 swollen tongue, mouth tingling Signs/Symptoms: Tingling in mouth, swollen tongue but looks fine Treatment: Benadryl PO (12.5mg); ... Read more
Signs/Symptoms: Tingling in mouth, swollen tongue but looks fine Treatment: Benadryl PO (12.5mg); less symptoms.
39 2021-04-11 vision blurred Chest Pain, Headache, Dizziness, Blurry Vision; BP 124/65; HR 90, RR 32, O2 100%; Fingerstick 83. Pt... Read more
Chest Pain, Headache, Dizziness, Blurry Vision; BP 124/65; HR 90, RR 32, O2 100%; Fingerstick 83. Pt observed for ~20 minutes, as per patient symptoms persisit.
39 2021-04-11 visual impairment tracers in my peripheral vision vertigo
39 2021-04-12 blindness Extremely rapid heart rate. Dizziness nauseous loss of sight everything went dark like I was passing... Read more
Extremely rapid heart rate. Dizziness nauseous loss of sight everything went dark like I was passing out. Not able to breathe properly as heart rate was so fast and I had pain in my chest because of this. Body felt like it was burning up. Once heart rate decreased I had uncontrollable snakes throughout my whole body. Like spasms. My head felt like it had a lot of pressure inside. My heart rate exceeded 100 but not sure if exact number. Paramedic on site took it.
39 2021-04-12 ear discomfort Chills began several hours after the 2nd dose. Lasted throughout the next day with a mild headache.... Read more
Chills began several hours after the 2nd dose. Lasted throughout the next day with a mild headache. 28 hrs after the shot, my arm begin swelling, fever began started at 99.9 to 101.5. Cramping in abdomin area and legs. Terrible headache and nausea. Lasted 5 hrs. Now Tuesday 4/13/21 and my arms is swollen about double the amount from the previous day. I have a lump under my arm pit and the area around my collarbone is swelling. I can feel pressure building in my ear and head. My throat is starting to hurt.
39 2021-04-12 mouth tingling Start feeling tingling and numbness starting from my neck extending to my chin, lips, and cheeks. Ha... Read more
Start feeling tingling and numbness starting from my neck extending to my chin, lips, and cheeks. Having trouble in swallowing. Started 30-45 mins after getting the shot and continue up to new ( some improvements over time but not fully recovered)
39 2021-04-12 mouth tingling Lip Tingling
39 2021-04-12 swollen tongue, lip swelling Immediate tingling in left arm, within 1 minute: dizziness, jittery ness, within 5 minutes: lips and... Read more
Immediate tingling in left arm, within 1 minute: dizziness, jittery ness, within 5 minutes: lips and tongue slightly swollen, continued adrenaline rush, feeling like I might pass out (though I never did). Waited at clinic with a nurse who monitored my symptoms for 1 hour and 15 minutes. After speaking with PCP, took Benedryl at ~2 hours post shot. Will monitor for the rest of today.
39 2021-04-12 swollen tongue, tongue discomfort On 03/18, I started experiencing burning on my tongue. My tongue became swollen and more irritated t... Read more
On 03/18, I started experiencing burning on my tongue. My tongue became swollen and more irritated throughout the day. This progressed in to 03/19, when my throat became sore and swollen as well. I felt like I do when I have strep throat with the amount of irritation in my throat and tongue. By the evening of 03/19, my tongue was so swollen it was hard to talk and articulate sounds. It was difficult to swallow liquids and I started to get scared. I took a Benedryl and went to sleep. The irritation and swelling eased Saturday and by Sunday afternoon, it was like nothing happened. I went to my general practitioner who sent me to an allergist and everyone agrees it sounds like an anaphylactic response to the vaccine, though unusual in the timing. I still have some burning and irritation on my tongue. My allergist is doing testing and ordered me an Epi-Pen.
39 2021-04-12 ringing in ears In about 1.5 h after the shot crawling sensation appeared on the site of vaccine. That sensation mov... Read more
In about 1.5 h after the shot crawling sensation appeared on the site of vaccine. That sensation moved up left side of neck, felt in head, lowered on the right side of neck and felt throughout the whole body. 911 was called, didn't find any stroke signs and left. Next day - vomiting (once) and diarrhea. The day after extreme headache that wouldn?t respond to double dose of Zomig 5mg, took 2 Tylenols and it subsided. Headache lasted for 5 hours. The day after ringing started in left ear with echoing of the sounds. Took 2 Tylenols and it subsided. Numbness in the left side of the head and left ear are persistent. Also experiencing extremely heavy period.
39 2021-04-12 ringing in ears Fever (1 day) abdominal cramps (1 day), extreme sweating (1 hr), ringing in ears (30 minutes), fatig... Read more
Fever (1 day) abdominal cramps (1 day), extreme sweating (1 hr), ringing in ears (30 minutes), fatigue
39 2021-04-13 dry mouth, mouth swelling, dry throat The patient received her Pfizer 1st dose Covid 19 Vaccine (Lot # ER 8731) at 0930 on 14 APR 21. PT h... Read more
The patient received her Pfizer 1st dose Covid 19 Vaccine (Lot # ER 8731) at 0930 on 14 APR 21. PT had a previous anaphylactic reaction to Morphine and was identified to be monitored for 30 minutes. At 0957, the PT alerted the staff that her throat was dry. At 0958, began monitoring the patient. VS: BP 131/87 HR 83 SpO2 100% RR 24 Rapid Assessment: -Pt alert and oriented. GCS 15. Distressed and diaphoretic. Complaints of throat dryness and sounded raspy. No complaint of throat swelling or tingling. No urticaria or erythema. Given water. At 1007, after the patient's condition did not improve, 911 was called.
39 2021-04-13 mouth numbness, oropharyngeal discomfort Tingling and numbness in lips, discomfort in throat, dizziness. No treatment. Tingling, numbness, a... Read more
Tingling and numbness in lips, discomfort in throat, dizziness. No treatment. Tingling, numbness, and dizziness subsided within 35 minutes of the vaccine. Discomfort in throat still constant over 9 hours later.
39 2021-04-13 mouth numbness Lips and tongue went numb within 10 minutes. Followed by dizziness and thoat tightening.
39 2021-04-13 mouth numbness At approximately 12:08 PM, pt became dizzy and lightheaded within 3 minutes post vaccination. Pt re... Read more
At approximately 12:08 PM, pt became dizzy and lightheaded within 3 minutes post vaccination. Pt reported nump lips and a scratchy throat with no issues with their tongue. Pt's vital were assessed and improved upon lying down on the cot. Pt released to husband.
39 2021-04-13 mouth numbness Felt cold wave on whole left side of body starting at the head and very quickly going down all the w... Read more
Felt cold wave on whole left side of body starting at the head and very quickly going down all the ways to toes. It happened as I was still in the car about 5 minutes after receiving shot. Immediately after felt numbness in left side of the face, left arm, and left leg (all mild). Numbness on the arm and leg stayed for about 4 hours, and numbness on the left side of the face stayed until the next morning. The numbness on the face was similar to when anesthetized by a dentist and also the tip of my tongue was numb. I could smile and close my eyes without a problem, and both right and left sides looked the same when doing so.
39 2021-04-13 swollen tongue, mouth numbness Dizziness, lips went numb, sides of mouth went numb, tongue began to swell.
39 2021-04-13 swollen tongue, lockjaw Sudden swelling of tongue, trouble swallowing, jaw locked up, couldn't speak 10 minutes after shot. ... Read more
Sudden swelling of tongue, trouble swallowing, jaw locked up, couldn't speak 10 minutes after shot. Took a benadryl 45 minutes after symptoms began.
39 2021-04-13 ringing in ears Headache - 2 MInutes later. Lasted 24 Hours Pain at Injection site - Started 12 hours later - Lasted... Read more
Headache - 2 MInutes later. Lasted 24 Hours Pain at Injection site - Started 12 hours later - Lasted 48 Hours Loud Tinnitus - 48 Hours Later - Improved but un-resolved a week later
39 2021-04-13 vision blurred Date and time adverse event started: Patient started to experience symptoms on her drive home after ... Read more
Date and time adverse event started: Patient started to experience symptoms on her drive home after taking the vaccine on 4/8/21 around 12:15pm-12:30pm. Patient stated she started to experience and feel symptoms on her drive home after the vaccine was given. Complains of soreness in arm at injection site, blurry vision, extreme headache and nerve pain, complete numbness in right leg (caused car accident), fever, body aches, chills, sweats increased neuropathy pain, left shoulder pain, n/v, extreme weakness and tiredness. No bowel movement since morning of 4/8/21. Appetite decreased tremendously due to n/v feeling. She has vomited twice on Thursday on 4/8/21 and once on 4/9/21. BP ON 4/8/21 around 4pm it was 178/122 and then at 7pm after taking bp medication it was 176/120. Patient experienced SOB and chest pressure/heaviness not painful on 4/8/21. Didn't take BP on 4/9/21. She took her normal medications for the day before the vaccine. When patient arrived at home she took Oxycodone, Buspar, Potassium tabs and Methocarbamol at 2pm on 4/8/21 (due time for her meds). On 4/8/21 at HS the muscle relaxer and pain killer was taken and it hasn't helped with the pain. As of 4/9/21 @2:19pm her neuropathic pain is 12 (on a scale of 1-10), she is breathing better today but still feels pressure, but still feeling all of the above symptoms. Recommended patient to go to an urgent care or ER, if she can't go then to make her PCP aware of what shes feeling. Advised her to take Tylenol for the fever, body aches, chills, and stay hydrated and eat light. 4/13-patient did not follow up with the ER/primary/urgent care as advised by prior entry. Patient states she has increased neuropathy from her baseline and continued nasal congestion. She took her rx medications but no additional medications for treatment. we will follow up with her next week to see how she is feeling. she is appreciative of the follow up call.
39 2021-04-14 mouth tingling Large red ring around the injection site still there after 48 hours, severe chills, headache and bod... Read more
Large red ring around the injection site still there after 48 hours, severe chills, headache and body aches, tingling mouth and some tightness of throat immediately after injection
39 2021-04-14 swollen tongue Red rash on chest and face, tingling feet, tongue swollen (patient said), child. Drove home. Refuse... Read more
Red rash on chest and face, tingling feet, tongue swollen (patient said), child. Drove home. Refused transportation to hospital.
39 2021-04-14 ringing in ears Noon: chills, body aches 3:00 PM: extreme tiredness, dizziness, ringing in ears, torso/neck rash, he... Read more
Noon: chills, body aches 3:00 PM: extreme tiredness, dizziness, ringing in ears, torso/neck rash, heavy bodied feeling, heaviness in chest
39 2021-04-15 dry mouth immediate complaint of racing heart rate and numbness in hands after vaccination, patient heart rate... Read more
immediate complaint of racing heart rate and numbness in hands after vaccination, patient heart rate max was 135 but then resolved in minutes and stayed in 80s-100. We put her in reclining chair, gave water and cookie. She stated she had not eaten all day--she then wanted something salty and ate potato chips. She appeared to be breathing fast and complained her mouth was dry. after an hour she requested an ambulance. We called one immediately. They transported her to the ED
39 2021-04-15 eye swelling My eyes were slightly swollen for a week. I had thought it is because of sleep posture. But it's bee... Read more
My eyes were slightly swollen for a week. I had thought it is because of sleep posture. But it's been swollen for a week and started next day after I took the vaccine. Also my left eye (close to left arm where I got the shot) swell more than the right eye.
39 2021-04-15 burning mouth syndrome Within 5 Minutes, Numbness, tingling and pain in arm. Within 15 -30 minutes after that, numbness, Ti... Read more
Within 5 Minutes, Numbness, tingling and pain in arm. Within 15 -30 minutes after that, numbness, Tingling and pain spread to face (forehead, cheeks, chin, nose) and to tongue. PA Prescribed Prednisone and Benedryl. After 2 doese, Pt can still not talk correctly and continues to have bilateral face pain and tingling as well as tongue and bilateral arm pain and tingling.
39 2021-04-15 mouth numbness @ 1220 Lightheaded, numb tongue (back), no SOB, states previous anaphylactic reaction to Naproxyn. ... Read more
@ 1220 Lightheaded, numb tongue (back), no SOB, states previous anaphylactic reaction to Naproxyn. @1230 OxSat 98%, HR 114, BP 140/112, BS 111. @ 1250 BP 150/110, RR 18, OxSat 99. Monitored pt until 1308. Stated light headedness gone, throat better, ready to leave. Son will drive her home. Was epi-pen in her purse and know where we are. Advised to contact PCP or seek medical attention if needed. Pt verbalized understanding of instructions and walked out with son.
39 2021-04-15 swollen tongue, swollen tongue tongue swelling, throat swelling
39 2021-04-15 swollen tongue Approx 4hrs after her dose , R side of face throat, tongue face began to swell. Lasted 20hrs approxi... Read more
Approx 4hrs after her dose , R side of face throat, tongue face began to swell. Lasted 20hrs approximately. Throat was swollen, self admin benadryl 50mg , 2 tabs. ALL of the symptoms has resolved.
39 2021-04-15 ringing in ears Presyncope occurred the morning after receiving the vaccine. I did not actually faint, but when I go... Read more
Presyncope occurred the morning after receiving the vaccine. I did not actually faint, but when I got out of bed in the morning and walked across the house I suddenly had ringing in ears, started sweating profusely, felt lightheaded and felt like I was going to faint. This lasted for at least a couple minutes. I'd received the vaccine at 9:10am on 4/14. The first side effects started around 8:15pm and were along the lines of what I expected: body aches, low fever, fatigue, chills. Overnight, despite the fatigue, I had trouble sleeping due to heart palpitations and intermittently feeling too hot or too cold, and eventually I had a headache. All night, I was falling asleep and waking up a little while later. At around 6:30am on 4/15, after sleeping poorly, my headache had gotten bad enough that I decided to take acetaminophen. I had not previously taken any medicine leading up to the vaccine or after getting the shot. I got out of bed and walked across the house, and that's when the presyncope came. Feeling very faint, I sat down, took the acetaminophen, and waited for the feeling to pass. Once the feeling did pass, I started to feel better pretty quickly, which may have been the medicine working, and then I was able to sleep for a few hours. A slight fever came back over the course of the day, I took a couple more small doses of acetaminophen as needed, and then on 4/16 I woke up feeling fine.
39 2021-04-15 vision blurred Headache (of head) Stiff muscles and weak muscles Funny nose Cough Sweating Cold sweats Being ho... Read more
Headache (of head) Stiff muscles and weak muscles Funny nose Cough Sweating Cold sweats Being hot and then cold Hands and feet always cold I am tired all of the time My vision will get blurry all of a sudden and then be fine My right hand will shake randomly Nauseous
39 2021-04-16 taste impairment Metallic taste in mouth several minutes afterword and extending next two days. Lower back pain, hea... Read more
Metallic taste in mouth several minutes afterword and extending next two days. Lower back pain, headache, joint pain, possible fever, fatigue--sleeplessness due to symptoms
39 2021-04-16 swelling of eyelid Urticaria on upper arms and upper tights and waist started Feb. 20. I took OTC Benaddryl and used ... Read more
Urticaria on upper arms and upper tights and waist started Feb. 20. I took OTC Benaddryl and used hydrocortisone cream with no improvment. On Feb. 25 I saw an urgent care who gave me a course of prednisone with no help. The urticaria continuly got worse and lasted all day with new areas effected. On March 8, I woke up to my left eye swollen shut and my whole body covered in hives and on fire and itching. I saw urgent care again who told me to see a dermolotogist. MArch 9 saw sermotoligst who gave me a cobetasol cream and hydroxyzine 10mg. I was told to also take claritin 10mg daily. Hives improved less body area and no swelling eye but still serveer hives. March 19 my legs were swelling and I incraesed my dose of hydroxyzine to 20mg and claritin 30mg per my dermotoligst orders. March 30 night I woke up to shortness of breath almost went to the ER. My dermotoligist orderd me an epi pen. I had a CBC, complement 3 &4 lab, metobolic panel, ASA , and h.pylori labs done all were within normal limits or negative. I had 2 punch biospies done one from hives on each arm on March 25- results given April 15 of Urticardia.
39 2021-04-16 ringing in ears Extremely severe tinnitus. Severe headache
39 2021-04-17 mouth numbness, mouth tingling Between 20-60 minutes of receiving the vaccine in my left arm, my lips and face started tingling and... Read more
Between 20-60 minutes of receiving the vaccine in my left arm, my lips and face started tingling and going numb, a sensation very similar to receiving novocaine when visiting the dentist. The sensation was primarily felt on the left side of my face, and had also affected my left arm, chest and leg by the time I was seen at the urgent care clinic. A MRI was conducted to rule out any kind of stroke event.
39 2021-04-17 ringing in ears increased intracranial pressure; Pseudotumor Cerebri; Transverse sinus stenosis; left sided pulsatil... Read more
increased intracranial pressure; Pseudotumor Cerebri; Transverse sinus stenosis; left sided pulsatile tinnitus; severe headache; Postural Orthostatic Tachycardia Syndrome; dizzy and light headed; Then I developed a red circle around the injection site a week after the injection; This is a spontaneous report received from contactable consumer (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 18Mar2021 12:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. No known drug allergies. The patient received other concomitant medications within 2 weeks of vaccination (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event started on 18Mar2021 13:15. The patient became dizzy and light headed within 30 minutes of receiving the first dose. The patient believed this was related to her postural orthostatic tachycardia syndrome (POTS). The symptoms lasted for approximately 12 hours. She also developed symptoms of increased intracranial pressure the morning after she received the first dose. The patient believed this was related to her pseudotumor cerebri (PTC) and transverse sinus stenosis (TSS). The symptoms included left sided pulsatile tinnitus and a severe headache. These symptoms lasted for approximately one week. Then she developed a red circle around the injection site a week after the injection. The patient contacted her neurologist as a result of all of symptoms. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. Information about lot/batch number has been requested.
39 2021-04-17 visual impairment, eye bleeding Had blood clot in left leg. Blood in eyes. Sinus sore throat short breath congested headache vision ... Read more
Had blood clot in left leg. Blood in eyes. Sinus sore throat short breath congested headache vision problems. Tested positive for strep one month after receiving one vaccine been taking antibiotics for 6 days but I'm getting worse.
39 2021-04-18 ringing in ears Severe tinnitus, intermittent headaches
39 2021-04-19 lip swelling Tingling sensation/swelling in lips
39 2021-04-19 mouth discomfort, eye irritation At 17 hours after the 2nd dose. I started with a fever, back pain, hips to the bones, followed by ch... Read more
At 17 hours after the 2nd dose. I started with a fever, back pain, hips to the bones, followed by chills and a bit of a headache. The acetaminophen was taken every 4 hours but as the day passed before 4 hours the fever and all the symptoms began. I felt as if I had fire inside my body. In the mouth and eyes. Then that fire continued and after 79 hours I noticed large welts on my legs, very intense itching and burning all over my body, I consulted a Dr on the phone and he told me to take Benadryl 50 every 8 hours, low a little the hives with the first dose but continued the same. I feel the allergy the same as when they administer Iodine and I feel acid or fire through my veins. I have not been to the hospital since I do not have the facility (the means or capability) to leave my children and be able to go with someone to the hospital. At this moment I write 4/20/2021 9:20 pm I am with these symptoms.
39 2021-04-20 feeling of choking The back of my throat started to tingle, then it started to swell. The staff at the CVS stuck me wit... Read more
The back of my throat started to tingle, then it started to swell. The staff at the CVS stuck me with an epi-pen. I waited for almost an hour after the epi-pen and the swelling did start going down. It didn't completely go down, back to normal, for several hours later. My airways were never completely restricted, it was just some swelling in the back of my throat.
39 2021-04-22 gaze palsy I passed out on 4/10/2021 at around 10:15 am at home when I was just walking without any warning sig... Read more
I passed out on 4/10/2021 at around 10:15 am at home when I was just walking without any warning signs of dizziness etc. I hit my head, started frothing from the mouth, my eyes rolled up and my whole body stiff. My husband tried to wake me. I opened my eyes after 10 mins and asked him what happened, which he explained after which I went and laid down. After laying down for about 15 mins I regained consciousness. I did not remember anything that happened the past 30 mins..I completely blanked out. We went to the ER where they did blood work, pregnancy test, EKG, CT scan of Head and put me on telemetry for about 8 hours which all came out Normal. They diagnosed me as having a Seizure. I got discharged from the hospital with referral to see Cardiologist and Neurologist to get MRI of head and EEG. I went to my appointments, got MRI of head, EEG, EKG, ECHO and Holter monitor tests done which all came out normal. Both the specialists said I do not need any medication or treatment. I talked to the Infectious Disease specialists in the hospital where I work and they said I should immediately report it to CDC and I should not take my Second dose of Covid vaccine until cleared by CDC. My 2nd shot was due today 4/23/2021.
39 2021-04-22 lip pain, lip swelling Onset of symptoms was around 12:30 am on 04/23/21. Symptoms began with lip pain followed by the fe... Read more
Onset of symptoms was around 12:30 am on 04/23/21. Symptoms began with lip pain followed by the feeling of puffiness around my lips , which then prompted me to look at them with a mirror. I noticed not only were they swollen but they were also slightly red as well. As of 3:36 am on 04/23/21 they are still swollen, painful and red.
39 2021-04-22 visual impairment I felt light halo in both eyes, visual artifact. At the ER they performed lab work and ultrasound... Read more
I felt light halo in both eyes, visual artifact. At the ER they performed lab work and ultrasound of the eyes. My symptoms to my eyes resolved on its own. I am at 35 weeks pregnant with high risk twin pregnancy, many medical factors being monitored.
39 2021-04-23 blindness Severe headaches, loss of vision with a beginning diagnosis of optical neurosis, continued headache ... Read more
Severe headaches, loss of vision with a beginning diagnosis of optical neurosis, continued headache and increased loss of vision In right eye after receiving steroids in hospital.
39 2021-04-23 pain in jaw Sharp tight pain in the middle of my chest with right jaw burning radiating from chin to right ear. ... Read more
Sharp tight pain in the middle of my chest with right jaw burning radiating from chin to right ear. First the nerve pain started about 1-2 mins after injection and then immediately after the nerve burning in my face was the chest tightness and sharp pain. Like it hurt to take a deep breath as well. The burning pain in my right side of my face passed after 20-30 mins and then the chest tightness and sharp pain passed a little longer about an hour.
39 2021-04-24 mouth numbness, thirst, mouth tingling difficulty swallowing; dizzy; Flush; Felt very hot; lips tingling; tongue felt a little bit numb; sh... Read more
difficulty swallowing; dizzy; Flush; Felt very hot; lips tingling; tongue felt a little bit numb; shaky; really thirsty suddenly; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: Unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 13:45 (at the age of 39-years-old) at as a single dose for COVID-19 immunization. Medical history included allergic to Compazine and allergic to dogs, both from unspecified dates and unspecified if ongoing. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications (medications received within 2 weeks of the vaccination) included vitamins NOS and ibuprofen, occasional, both taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Apr2021 the patient experienced, difficulty swallowing, dizzy, flush, felt very hot, lips tingling, tongue felt a little bit numb, shaky and really thirsty suddenly. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was received for the events and included Benadryl, Prednisone and an Epipen was prescribed but was not used. The clinical outcomes of the events difficulty swallowing, dizzy, flush, felt very hot, lips tingling, tongue felt a little bit numb, shaky and really thirsty suddenly were all recovering/resolving. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot number cannot be obtained.
39 2021-04-24 ringing in ears, deafness Severe vertigo, tinnitus, then complete hearing loss in right ear.
39 2021-04-25 feeling of choking At approximately 8:30 AM patient received 2nd dose of Pfizer vaccine in the right arm at the Public ... Read more
At approximately 8:30 AM patient received 2nd dose of Pfizer vaccine in the right arm at the Public Health Center's drive through vaccine clinic. She was accompanied by her husband who was driving her vehicle. At 8:34 AM she notified staff in observation parking area that she felt dizzy, chest pain, and reported wheezing. Two RN's responded at 8:34 AM to observation parking area with emergency kit. Upon arrival, patient verbalized again that she felt dizzy, chest pain and tightness now, no audible wheezing heard, patient's skin was pale, and her respiratory rate was high. Advised patient to take slow deep breaths and to try to relax and remain calm. No improvement. At 8:36 AM called 911 for the patient to be evaluated. While one RN was on the phone with 911 operator, patient reports to the second RN throat pain/ tingling, difficulty swallowing, a feeling of a "lump in her throat", continued chest pain and tightness, and states that she feels she cannot breathe in or out well. Per standing order Epinephrine 0.3 mg administered in the right thigh IM. Both RN's remained on scene. No improvement, and patient continued to state it was getting harder to breathe, and that her throat was tingling and she could hardly swallow. At 8:44 AM 0.3 mg Epinephrine administered in the left thigh IM per standing order. At 8:50 AM EMS arrived. Patient had improvement. Vital signs stable upon arrival per EMS. Breathing difficulty improved upon EMS arrival. No further difficulty swallowing reported. Chest pain reported to be improved as well. 8:55 AM EMS transported patient to local hospital. Attempted to contact the patient on 04-26-2021 to determine outcome of event. Phone went to voicemail. Voice message left.
39 2021-04-25 tunnel vision Approximately 22 hours post vaccine injection, I felt like I was going to pass out. I got hot, swea... Read more
Approximately 22 hours post vaccine injection, I felt like I was going to pass out. I got hot, sweaty, ringing in both ears, and tunnel vision. I had to lay down for an unknown amount of time until the feeling passed.
39 2021-04-26 taste impairment, smell distorsion Fainted; extreme dizziness and disorientation since; extreme dizziness and disorientation since; met... Read more
Fainted; extreme dizziness and disorientation since; extreme dizziness and disorientation since; metallic taste in mouth; smell metal coming out of pores; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient (not pregnant, age at vaccination 39-year-old) received the second dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand=Pfizer, Batch/Lot number was not reported), via an unspecified route of administration in the left arm, on 12Mar2021 09:00 as SINGLE DOSE for Covid-19 immunisation. Medical history included allergy to contrast dyes. She reported of Covid prior vaccination. She had her first dose of bnt162b2, 09am (lot unknown), left arm on 19Feb2021. Concomitant medications was antibiotics (unspecified) in two weeks. On 12Mar2021 09:15, the patient experienced faint/fainted, extreme dizziness and disorientation, metallic taste in mouth and had a smell metal coming out of pores (no treatment for the events). She had a clinic visit and Emergency room/department visit. The patient was hospitalized for 2 days due to the events. The patient underwent laboratory test Sars-cov-2 test: negative on 01Apr2021. The outcome of events was recovering. Information about lot/batch number has been requested.
39 2021-04-26 taste impairment Patient reported having metallic taste in mouth about 15 minutes after receiving the immunization an... Read more
Patient reported having metallic taste in mouth about 15 minutes after receiving the immunization and wanted us to report it. She also said that she had a metallic taste after the first shot. Patient had anxiety about the shot and was not sure if she had a little trouble swallowing because of the shot or the anxiety.
39 2021-04-26 eye itchiness Pt reported itchiness in her arm, forehead, and eyes. Pt was administered w/ 25mg Benadryl LOT 0810... Read more
Pt reported itchiness in her arm, forehead, and eyes. Pt was administered w/ 25mg Benadryl LOT 0810127
39 2021-04-26 taste disorder Itchiness all over her body; Weird taste in her mouth; dizzy; The initial safety information receive... Read more
Itchiness all over her body; Weird taste in her mouth; dizzy; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 12Apr2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8735) via an unspecified route of administration, administered on the left deltoid on 31Mar2021 18:00 at a single dose for COVID-19 immunization. The patient had no medical history. Family medical history included that her dad has severe allergies. There were no concomitant medications. On 31Mar2021, after 1st dose of the Pfizer covid vaccine, she experienced weird taste in mouth and felt little dizzy both went away immediately, not too concerned. Saturday 03Apr2021 until Saturday 10Apr2021, had itchiness all over her body, she was asking since she had a mild reaction, when she goes next week, if it will be really bad. It was really bad itching, she didn't think it would go away. Patient thought she had a reaction to the first dose of the covid vaccine, it was not deadly. She was trying to figure out if it was safe to her to get the second dose of the covid vaccine next week. Itchiness all over her body: The only place she did not itch was her hands and feet. Her scalp, back and everything itched. She mostly itched on her torso and scalp. She even itched inside of her ears. She does not take any medications. She was healthy. She has no known drug allergies. She has not started any new products. She kept going about her business, but the itching was getting worse and worse until this weekend. Last Wednesday, 07Apr2021, the itching was so bad that she took a Benadryl to see if it would help. She does not like to take medications. She also used calamine lotion. She took Benadryl children's dose and it did not help the itching. She thinks that the dose was 10mg, but she does not know for sure. It was a new package, she had just bought it. Benadryl children's dose did not help at all. All of a sudden, the itching resolved on Saturday, 10Apr2021. She was out a lot in the sun all day Saturday. The sun seemed to help, she does not know if it was related. She did not have any hives. It felt like chicken pox to her but with no pustules. The itchiness all over her body was awful. She does not know. She has never had anything like this happen to her before. Her concern was if she had a mild reaction to the first dose of the covid vaccine, what was going to be like whenever she goes next week for her second dose of the covid vaccine. She was asking if it will be really bad. She was itching so bad that she took a Benadryl to see if it would help. She took Benadryl children's dose and it did not help the itching. Event itching was reported as serious, medically significant. After reviewing call recording, patient reported when she was at the vaccine facility nothing really major happened, she had a little bit of a weird taste in her mouth, nothing strange. She did get a little bit dizzy but nothing that did not wear off shortly thereafter, so she went about her life normally. The weird taste and dizzy feeling started within minutes of receiving the vaccine. The events did not require a visit to emergency room and physician office. She was lucky enough to work with doctors, so she just talked to them. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was in a pharmacy. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the event itchiness all over her body was recovered on 10Apr2021, while the other events recovered on 31Mar2021.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported pruritus cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
39 2021-04-27 mouth tingling, feeling of choking Patient experienced "throat and lip tingling" immediately post vaccination, but did not inform medic... Read more
Patient experienced "throat and lip tingling" immediately post vaccination, but did not inform medical staff until 30-40 min post injection. The tingling progressed to "tightness." around 45 min post vaccination. The OP was visualized and mildly erythematous initially. Loratidine 10mg PO x1 administered at this time. The OP erythema progressed with no resolution of reported "tightness", therefore Diphenhydramine 0.5ml IM administered. Sxs began to improve over 30 min. EMS was notified to further evaluate patient. Patient declines transport to ED. AFVSS throughout medical response. Patient was monitored an additional 15 min after EMS completed eval and was dc'ed home with strict ED precautions.
39 2021-04-27 eye floaters After receiving the ?Pfizer-BioNTech COVID-19 Vaccine EUA" on April 9, I developed a yellow floater ... Read more
After receiving the ?Pfizer-BioNTech COVID-19 Vaccine EUA" on April 9, I developed a yellow floater in my vision, which I noticed nine days after receiving the vaccine. There has not been any other trauma that could have caused this event. I then saw a retina specialist on April 26, as the floater had not gone away yet. I was diagnosed with a Retinal Hemorrhage of the right eye. I am being followed by my physician, but the bleeding continues to cause a yellow floater in my right eye.
39 2021-04-28 ear congestion, ringing in ears, hearing loss The patient reports dizziness, brain fog, and left ear plugging, left ear reduced hearing, and left ... Read more
The patient reports dizziness, brain fog, and left ear plugging, left ear reduced hearing, and left ear pulsatile tinnitus. They began at the time of her second vaccine. After a course of Prednisone started 4/19/2021 the pulsatile tinnitus has resolved but not the brain fog and dizziness.
39 2021-04-28 ear pain Swollen and sore throat. Difficulty swallowing Congestion, pain in ears, and mild cough
39 2021-04-28 mouth numbness, mouth tingling numbness, tingling, and swelling of her hands and feet; numbness, tingling, and swelling of her hand... Read more
numbness, tingling, and swelling of her hands and feet; numbness, tingling, and swelling of her hands and feet; numbness, tingling, and swelling of her hands and feet; muscle weakness; unable to walk unassisted; Vitamin D deficiency; muscle cramps in her lower extremities that progressed to her upper extremities and neck; muscle soreness in her lower extremities that progressed to her upper extremities and neck; intermittent numbness/tingling of my inner upper lip; intermittent numbness/tingling of my inner upper lip; This is a spontaneous report from a contactable other healthcare professional (HCP) reported for herself. A 39-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot Number: EN16208) at the age of 39-years-old as single dose for covid-19 immunisation. Patient was not pregnant. Medical history included Hormonal Acne, gastrooesophageal reflux disease (GERD). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included spironolactone taken for an unspecified indication, start and stop date were not reported; esomeprazole magnesium (NEXIUM) taken for an unspecified indication, start and stop date were not reported; aluminium hydroxide, magnesium trisilicate, sodium alginate (PEPCID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefalexin monohydrate (KEFLEX) and experienced allergy. The patient initially had some intermittent numbness/tingling of her inner upper lip that began within the first hour of receiving the vaccine on 19Mar2021 and lasted about 24 hours. Six days following vaccination on 25Mar2021, the patient began having muscle cramps/muscle soreness in her lower extremities that progressed to her upper extremities and neck, By the eighth day on 27Mar2021, she had developed numbness, tingling, and swelling of her hands and feet. On this day, she also began having muscle weakness and was unable to walk unassisted by the end of the day. She was seen in the Emergency room (ER), admitted, and transferred to another facility. The patient hospitalized for 1 day. She underwent a Computerised tomogram (CT) scan of my head, Magnetic resonance imaging (MRI) of my brain/neck, lumbar puncture, and extensive blood work. All of her work up was unremarkable except for showing that she had a Vitamin D deficiency. Her symptoms began to improve without treatment in the hospital, and she was discharged home with the diagnosis that she had most likely had an unusual, adverse reaction to her 1st dose of the COVID 19 vaccine and was instructed not to receive my 2nd dose. Covid tested post vaccination (Nasal swab) on 28Mar2021: Negative. The outcome of the events 'numbness/tingling of my inner upper lip' was recovered on 20Mar2021 and the outcome of the other events was recovering.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Myalgia, Muscle cramps, Hypoasthesia, Parasthesia, Pheripheral swelling, Muscle weakness and Vitamin D Defiency. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-04-28 mouth tingling Patient c/o tingling in mouth and tongue, and in hand 25 minutes post vaccination. Patient states th... Read more
Patient c/o tingling in mouth and tongue, and in hand 25 minutes post vaccination. Patient states this happened last time and resolved with Benadryl. No c/o SOB, lightheadedness, itchiness/rash. Does not appear to be in respiratory distress. Gave 25mg liquid Benadryl at 11:15am. Pt stayed 20 minutes, no change in symptoms. Advised to ER for possible reaction but patient declined and said she would be with someone and they would call 911 if any worse.
39 2021-04-29 mouth numbness, mouth tingling Felt lightheaded after receiving vaccine. Stayed at pharmacy for 30 mins. Later that evening had int... Read more
Felt lightheaded after receiving vaccine. Stayed at pharmacy for 30 mins. Later that evening had intense headaches and the feeling of blood rushing to my head. The next morning my headache subsided some and I drove to work. My throat felt tight and continued to feel tight through the morning. At 11:30 I called the pharmacy because my throat tightness continued to get worse and it was difficult to eat my breakfast. Also my lips began to go numb and tingle. I was told to immediately go to the ER. I went to ER and was seen by Dr. in the ER. They did xrays of my throat and bloodwork, inserted an IV and gave me steroids thru the IV. Within about 30-40 mins I began to feel better. I was prescribed steriods to take for 6 days at home. I have continued to have headaches, mainly at night and extreme inflammation in my neck, chest/clavicle area, back of neck and shoulders from my lymphnodes, difficulty sleeping flat. This is now 4 days after the shot and I am beginning to feel a little better, just still swollen lyphnodes and mild headache.
39 2021-04-29 ringing in ears, mouth numbness Within 6 minutes heart rate was elevated and blood pressure was high with ringing in ears. Lips and... Read more
Within 6 minutes heart rate was elevated and blood pressure was high with ringing in ears. Lips and tongue were numb, tightness in throat. Hives developed on ears and back of neck. Had difficulty concentrating and confusion. Felt like passing out. Pharmacist did not react or call for ambulance because I was still breathing. My husband had to drive me home. I have a doctor as a neighbor who was home when I got home still having reaction 30 min after the shot and took blood pressure that was extremely elevated (top number in 200) and heat rate still over 100bpm. Took 50mg Benadryl and symptoms started decreasing within an hour and blood pressure was decreasing but still higher than normal. By 7pm, blood pressure was back to normal and heart rate back to 70bpm.
39 2021-04-29 ringing in ears Pfizer-BioNTech COVID-19 Vaccine EUA On 3/31/2021 I developed a headache, fatigue, ringing in ears a... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA On 3/31/2021 I developed a headache, fatigue, ringing in ears and tachycardia. Later that night I developed hives on my forehead that was resolved with oral Benadryl. On 4/22/2021 I developed burning fatigue in my arms and legs, the headache and ringing in ears have still continued. I saw my PCP on 4/26/2021 for daily headaches, ringing in ears and fatigue/burning in arms that started after receiving the Pfizer vaccine. A prednisone dose pack was prescribed. I am currently on day 4 of steroids and fatigue has improved slightly, still having headaches and ringing in ears.
39 2021-04-29 ringing in ears Right side ear completely numb. Tissues surrounding ear including face, neck and head above and behi... Read more
Right side ear completely numb. Tissues surrounding ear including face, neck and head above and behind ear completely numb. Sudden onset ringing in both ears.
39 2021-04-30 deafness unilateral, ear pain, ringing in ears Right ear was losing hearing sporadically; Pain in surrounding area on face and cranium on same sid... Read more
Right ear was losing hearing sporadically; Pain in surrounding area on face and cranium on same side; Pain in surrounding area on face and cranium on same side/Periodic headaches on same side; Feels a bit like swimmer's ear with pain and muffled sounds; Feels a bit like swimmer's ear with pain and muffled sounds; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 14Apr2021 14:15 (at the age of 39-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included irritable bowel syndrome (IBS) from an unknown date. The patient had known allergies with lactose (lactose intolerance). The patient had no covid-19 prior vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), administered in arm left on 24Mar2021 02:45 PM (at the age of 39-years-old) for covid-19 immunisation. Concomitant medications included vitamin d3; zinc; magnesium; calcium; and vitamin b6; all were taken for an unspecified indication, start and stop date were not reported. On 15Apr2021 12:00PM, the right ear was losing hearing sporadically. Pain in surrounding area on face and cranium on same side. Periodic headaches on same side. Feels a bit like swimmer's ear with pain and muffled sounds. It was unknown if the patient did received any treatment for the events. The outcome of the events was not recovered. The patient did not covid-19 tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
39 2021-04-30 ear discomfort, ringing in ears approximately 2 weeks post second dose I started with a low level , high pitched tinnitus in the rig... Read more
approximately 2 weeks post second dose I started with a low level , high pitched tinnitus in the right ear. It has been constant since that time with no improvement or worsening. Occasional (approximately 5 days total) I've had days where I can also feel pressure in the right ear, discomfort with swallowing. On 2 occasions I've experienced a momentary intensity of the tinnitus but then it returns to the "normal" level
39 2021-04-30 ringing in ears Tinnitus in right ear. Constant fluttering and pulsing sound. Have never had this occur prior to get... Read more
Tinnitus in right ear. Constant fluttering and pulsing sound. Have never had this occur prior to getting the vaccine.
39 2021-05-01 swollen gums, painful gums Mouth sores, swollen and painful gums, enlarged cervical lymph nodes
39 2021-05-01 ringing in ears Bilateral moderate tinnitus starting around 8 hours after the second Pfizer shot. Still present with... Read more
Bilateral moderate tinnitus starting around 8 hours after the second Pfizer shot. Still present with no improvement 10 days after injection. No treatment has been given.
39 2021-05-01 ringing in ears 1. within 10 minutes I had increased heart rate, which went away within next 3-5 minutes than I had ... Read more
1. within 10 minutes I had increased heart rate, which went away within next 3-5 minutes than I had another episode, 10-15 min after the first episode, again it went away within 2-4 minutes 2. 04/13/21 by the evening the same day of vaccination I developed pain in the shoulder, arm, hand, neck, breast and underarm on the left side (injection side), left ear, head. Within 24 h form injection I developed ringing in the left ear. 3. Ringing got worse within next 48h. Headache was very bad in the evening/night on 13 -16 of April. Also felt tightness in my throat when swallowing. 4. 04/16/21 - ringing in the ears still there, no improvement, very loud. Tightness in my throat when swallowing, postnasal drip 5. 04/17/21 ? ringing in the ear still there, no improvement, slight pain in the shoulder, and intermittent headache and pain in the left ear, postnasal drip. 6. 04/18 ? 05/02/21 ? constant tinnitus, no improvement, postnasal drip is lessening.
39 2021-05-02 mouth tingling After 35 min post vaccination patient was anxious and reported that she has "little tingling" on her... Read more
After 35 min post vaccination patient was anxious and reported that she has "little tingling" on her upper lip. Throat feels like "pins and needles" inside. Mild headache. Given Benadryl 25 mg PO x1. Patient stable, released from vaccination site.
39 2021-05-02 vision blurred 2nd shot - Immediately after getting this shot, my entire arm went numb and tingly all they way down... Read more
2nd shot - Immediately after getting this shot, my entire arm went numb and tingly all they way down into my fingers. Then by the time I got home my entire left side was numb and tingly - myleft eye was blurry, my left jaw felt funny, my left hip and leg were numb making it hard to walk and balance. This went away by the next morning (thank goodness). But I still had a Very sore Arm and some tingling in that arm. I also had intense pain and swelling in my arm pit starting day 3 thru 6 (now), this is pretty serious swelling in that area - my left arm pit, shoulder, even my left breast is swollen and very tender to move or touch. I have also gotten random chills a couple times a day that last for an hour or so, and I have had random nausea (about once or twice a day for an hour or two). Finally overall fatigue for the past 6 days.
39 2021-05-02 visual impairment A wave like feeling came over her, followed by a transient tightness in her throat. Very brief "dark... Read more
A wave like feeling came over her, followed by a transient tightness in her throat. Very brief "dark vision" without classic tunnel vision. No SOB, itching, tongue thickness, or diaphoresis. VSS throughout without orthostasis. Initial BP - 131/76, Pulse 66, Resp - 19, O2 sat - 99% All symptoms spontaneously resolved before arriving at Observation Pod. Suspect simple anxiety.
39 2021-05-03 loss of taste, loss of smell I got covid. I only lost sense of smell and taste and my arm was weak for a day after. Other than th... Read more
I got covid. I only lost sense of smell and taste and my arm was weak for a day after. Other than that, I was okay
39 2021-05-03 double vision Double vision for 1.5 days Vertigo for 2 days Pain in left side of body ongoing Injection site red a... Read more
Double vision for 1.5 days Vertigo for 2 days Pain in left side of body ongoing Injection site red and painful ongoing Heavier than normal menstrual period for a week and possibly effecting daughter with hers as well
39 2021-05-03 eye discharge, swelling of eyelid First pregnancy - EDC 09/18/21, RH negative (spouse is positive), Advanced maternal age - First adv... Read more
First pregnancy - EDC 09/18/21, RH negative (spouse is positive), Advanced maternal age - First adverse event on 09/11/21 included minor spotting while using the bathroom 2 days after 2nd dose of the Pfizer shot - pregnancy at 17 weeks, 1 day. I contacted my doctor via the online message system and advised her of the spotting. She instructed me to rest and take fluids. - Second adverse event on 09/13/21 (17 weeks, 3 days pregnant)- I woke up with a swollen right eye, which was crusted shut with mucus. My first thought was that it was either debris in my eye or pink eye. I made an appointment with the eye doctor and he said that it's likely a stye forming and to use a warm compress. - Third adverse event on 09/16/21 (17 weeks, 6 days pregnant) - I tried using the bathroom to pass a stool and was finding myself a bit constipated (which hasn't been uncommon in this pregnancy). I experienced enough bleeding to have blood in the toilet and continuous blood while wiping. I went immediately to the ER for treatment.
39 2021-05-03 ringing in ears I started getting dizzy and ears ringing almost 15 minutes after I got the shot. I told my husband ... Read more
I started getting dizzy and ears ringing almost 15 minutes after I got the shot. I told my husband I didn't feel right and then passed out. I am told I turned white and my chest was not noticeably moving. Nurses tried for about 30 seconds or so to get me to wake up before I came around. I laid on the floor for a few minutes. When they tried to get me to sit up I started to feel quite dizzy again and asked to lay down. After a few minutes they brought a wheelchair and started wheeling me from the vaccine clinic to the ER. While in the wheelchair I passed out again. I also noticed tingling in the outer half of both hands, and my hands were curling up involuntarily. It took a couple of hours for me to start to feel like I could think clearly. I did not feel well for several days after receiving the vaccine. I was extremely tired and got a lot of dizzy spells for about 4 days afterwards.
39 2021-05-04 swollen tongue Angioedema and anaphylaxis approximately 15 minutes after the vaccine was administered. She was giv... Read more
Angioedema and anaphylaxis approximately 15 minutes after the vaccine was administered. She was given IV solumedrol, benadryl, and famotidine which improved her tongue swelling. Afterwards she was admitted to an inpatient observation unit at the hospital. Around 9pm patient developed recurrent tongue swelling and difficulty swallowing. 0.5 mg of epi was administered. There was some initial improvement followed by additional worsening after 5 minutes. She was ultimately transferred to the ICU for a continuous epi infusion.
39 2021-05-05 eye irritation patient reported eye irritation and burning. denies blurry vision. patient was observed for 115-20 ... Read more
patient reported eye irritation and burning. denies blurry vision. patient was observed for 115-20 minutes. then felt better and was driven home
39 2021-05-05 mouth tingling, mouth numbness Lip and tongue numbness/tingling lasting 5-6 hours, resolving spontaneously
39 2021-05-06 loss of taste, loss of smell New loss of taste or smell
39 2021-05-06 toothache Tingling on and off in my left hand, left eye twitching every few minutes, left side neck pain, left... Read more
Tingling on and off in my left hand, left eye twitching every few minutes, left side neck pain, left lung pain, started the day after I got vaccine ended 8 days later. Severe pain in all of my teeth on the right side of my face started the day after I got the vaccine and lasted about 4 hours. Headache, nausea, and diarrhea for 2 days after vaccine.
39 2021-05-07 mouth tingling In order of onset? Lip Tingling (20 min after vaccination) Facial flushing (20 min after vaccinatio... Read more
In order of onset? Lip Tingling (20 min after vaccination) Facial flushing (20 min after vaccination) Swelling of throat/uvula (30 min after vaccination ) Throat irritation (60 min after vaccination) Symptom relief after 2 antihistamine tablets 50mg (Benadryl)
39 2021-05-07 drooling Headache; excessive saliva; burning sensation in the throat.; This is a spontaneous report from a no... Read more
Headache; excessive saliva; burning sensation in the throat.; This is a spontaneous report from a non-contactable other HCP (patient). A 39-year-old non-pregnant female patient reported for a herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: El8982) via an unspecified route of administration on her left Arm on 04Feb2021 (at the age of 39-years-old), at single dose for COVID-19 immunization. The patient's historical vaccine included received first dose of BNT162B2 (Comirnaty, formulation: Solution for injection; lot number=Ed0142) on 14JAN2021 at 12:00 pm via intramuscular route on left arm for COVID-19 immunization. The patient's medical history was not reported. It was reported that covid prior vaccination and covid tested post vaccination as No. Also, allergies was reported as no. The patient's concomitant medications included sertraline hydrochloride (Zoloft), bupropion hydrochloride (Wellbutrin), levothyroxine sodium (Levothyroxin), pregabalin (Lyrica) and spironolactone; all start and stop date were not provided and used for unknown indication. On 04Feb2021 at 02: 30 PM, the patient developed headache, excessive saliva and burning sensation in the throat for which she did not received any treatment. The outcome of all the events was recovered in Feb2021. No follow-up attempts were possible. No further information was expected.
39 2021-05-07 lockjaw Patient received her first dose of Pfizer COVID 19 vaccine at off-site pharmacy COVID vaccine clinic... Read more
Patient received her first dose of Pfizer COVID 19 vaccine at off-site pharmacy COVID vaccine clinic at 4:40pm on 05/07/2021. About 12 mins after receiving the vaccine, pt started to feel nauseated and asked for something to throw up in. She complained of chest tightness, shaking feeling, itching sensation in her face, and jaw locking. Epi pen (0.3mg) was administered at 4:55 pm and 911 was called. Pt's daughter was present and said pt did not have any known allergy and never had any adverse reaction to vaccinations previously. Fire department arrived after 911 call was made, and they took her for further observation.
39 2021-05-09 taste impairment, dry mouth, feeling of choking Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 5/10/2021 10:30 AM Expand... Read more
Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 5/10/2021 10:30 AM Expand AllCollapse All COVID VACCINE CLINIC 5/7/2021 Date: 5/7/2021 Subjective Patient is a 39 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle done in the medical bay due to having anxiety and feeling worked up. She reported to feeling sad before coming in today as her grandmother passed a week ago (non-covid related), pt was hoping GM would hold on until pt got her 2nd vaccine so she could see her GM. Pt also has other family things going on that is causing her to feel emotional. She also was seen in the bay for her vaccine as she has a recent hx to the ED on 05/02/21 for tongue swelling. She took benadryl prior to her arrival to the ED at that time, symptoms had resolved for her then. During her 30 minute waiting period after the injection, the patient began to experience cough, throat itchiness, tongue tingling. She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Past Medical History: Diagnosis Date ? ADHD ? Chronic fatigue ? Chronic fatigue syndrome ? Head ache menstral related ? Hypersomnia, idiopathic ? IBS (irritable bowel syndrome) ? Interstitial cystitis ? MTHFR gene mutation ? Myofascial pain syndrome ? PMDD (premenstrual dysphoric disorder) ? PTSD (post-traumatic stress disorder) ? Rosacea ? Sinusitis ALLERGY REVIEW OF SYSTEMS: Patient complains of cough Patient denies chills, fever, malaise/fatigue, facial swelling, frequent throat clearing, chest tightness, shortness of breath, wheezing, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches + throat and tongue itching. : Previous Reactions:none but see above about ED visit on 05/02/21 Objective Vitals Vitals: 05/07/21 1140 05/07/21 1151 05/07/21 1206 BP: 137/82 (!) 141/92 127/59 Pulse: (!) 130 (!) 101 99 Resp: (!) 26 20 16 SpO2: 100% 100% 100% Physical Exam Constitutional: Appearance: She is obese. She is not diaphoretic. Comments: Flushed, HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: No tongue swelling noted. Speaking full sentences. Pt does report cotton mouth. She is able to swallow w/o difficulty. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Regular rhythm. Tachycardia present. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Tachypnea (hyperventilating) present. No respiratory distress. Breath sounds: No wheezing. Comments: Clear breath sounds with slight diminished to apex. Improved with albuterol use. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal. 1158: pt reports improvement of symptoms, "especially after the use of albuterol" but has metallic taste and tongue tingling. Itching has resolved. She feels like she is on the right right of "recovery.". We went ahead and gave her some zyrtec and pepcid as well. About 5 minutes prior we gave her a minty loungeze which may be contributing to tongue tingling. Lungs cta, no tongue swelling noted, speaking full sentences, hyperventilation-resolved-eupneic, heart rate normal range. flushing of face improved as well. Assessment/Plan Treatment included: albuterol, antihistamines and water Follow up response to treatment: good. Patient discharge: Transported to ED by POV. Differential Diagnosis: Systemic reaction (headache, itching, tachycardia, hypoglycemia, hypotension, generalized rash) Stable and improving symptoms. Certainly anxiety may be a factor playing into this but recommended that she seek emergency care for observation and follow up with her primary care along with allergist to look into her two reactions that she has had this week. She declined EMS and wishes to go by pov. Husband here to transport her. VS stable and exam unremarkable. Pt and husband voiced appreciation of care today. ED charge nurse notified of patient's coming. Dr. updated on pt's visit today. Electronically Signed 5/7/2021 12:06 PM
39 2021-05-09 taste impairment Right after vaccination patient developed a metallic taste in mouth and became warm. Recipient was e... Read more
Right after vaccination patient developed a metallic taste in mouth and became warm. Recipient was evaluated by on-site EMS and was stable and denied transportation to the hospital.
39 2021-05-09 ear discomfort, ringing in ears I have been feeling foggy and slightly dizzy. Pressure in my left ear. Ringing in my left ear. ad 2 ... Read more
I have been feeling foggy and slightly dizzy. Pressure in my left ear. Ringing in my left ear. ad 2 vertigo spells to the point where I could not drive and one where I had to lie down immediately to prevent falling. I have been anxious, having waves of anxiety.
39 2021-05-09 sensitivity to light, eye pain Migraine with light sensitivity on day following vaccine. On 4/26, light sensitivity went away but t... Read more
Migraine with light sensitivity on day following vaccine. On 4/26, light sensitivity went away but the intense migraine continued. (And still continues.) Feels like a metal rod is going from my right occipital through my right eye socket.
39 2021-05-09 drooling, taste impairment, mouth tingling, feeling of choking 2nd COVID-19 vaccine late afternoon 3 days ago on Friday, 5/7/21. As soon as injection occurred, pt ... Read more
2nd COVID-19 vaccine late afternoon 3 days ago on Friday, 5/7/21. As soon as injection occurred, pt had increased saliva (mild), metallic taste, tingling tongue. She did not advise pharmacist at pharmacy/administrator of sxs, she stayed another 10 minutes & did not tell anyone of her "mild" sxs, left. On the way home, started to get tingling in her throat (points to suprasternal notch), itching started on soles of both feet, then started feeling itching all over. Called pharmacy, was advised she should call 911. Called a nurse friend, advised to take Benadryl immediately, took 50 mg by mouth after she could get to the pharmacy to get it, then felt it start working 18-20 min later, noticed when it started that she
39 2021-05-09 swollen tongue After administration of 2nd dose, pt's tongue and throat began to swell. Developed itchiness to head... Read more
After administration of 2nd dose, pt's tongue and throat began to swell. Developed itchiness to head, face, and neck. Physician on site informed, placed IV, and administered diphenhydramine 50mg, famotidine 20mg, methylprednisolone 125mg and then patient was transported to the ED. In the ED, she was monitored for 2 hours and discharged with prescriptions to take famotidine 20mg daily x 5 days and prednisone 40mg daily x 5 days, and benadryl every 8 hours x 48 hours.
39 2021-05-09 swollen tongue Tongue swelled and throat felt tight about 30 minutes after the shot. I immediately went back into ... Read more
Tongue swelled and throat felt tight about 30 minutes after the shot. I immediately went back into the clinic at Hospital to report my reaction to a nurse. The nurse sent me to the ER to be monitored and receive Benadryl since my reaction wasn?t worsening. My tongue and feeling in my throat improved with their care.
39 2021-05-09 ringing in ears I have constant ringing/buzzing in my right ear that has started last night (5/9/2021) at approximat... Read more
I have constant ringing/buzzing in my right ear that has started last night (5/9/2021) at approximately 9 pm and has not stopped
39 2021-05-10 ear discomfort, mouth tingling tingling of tongue, ear felt weird, Benadryl administered and some improvement but not completely an... Read more
tingling of tongue, ear felt weird, Benadryl administered and some improvement but not completely and 911 called after started to go further in mouth
39 2021-05-10 burning mouth syndrome Day after vaccine, frequent urination, burning pain in neck/throat, tongue hurts, fever
39 2021-05-10 pain in jaw Headache, body aches, jaw ache, sore throat, skin sensitivity, fatigue and stomach pains.
39 2021-05-10 visual impairment, eye disorder Intermittent, severe, spasmodic neuro muscular facial contracture and eye closure, worse on right si... Read more
Intermittent, severe, spasmodic neuro muscular facial contracture and eye closure, worse on right side began approximately 3 weeks after 2nd Covid-19 vaccination injection.
39 2021-05-11 eye swelling Left eye swollen; Rash on left arm from injection site down to elbow for 5 days.; Lymph nodes swolle... Read more
Left eye swollen; Rash on left arm from injection site down to elbow for 5 days.; Lymph nodes swollen.; This is a spontaneous report from a contactable Other HCP. A 39-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262) via intramuscular route of administration in left arm on 22Jan2021 06:45 as single dose for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient has known allergies of bactrum and cellebrex. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration on unspecified date as single dose for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 22Jan2021 at 11:00 left eye swollen shut about 4 hours after receiving second dose. Rash on left arm from injection site down to elbow for 5 days. Lymph nodes swollen. Patient received treatment for the events with 2 doses of Benadryl. Outcome of the events were recovered with lasting effects. No follow-up attempts are possible. Information about batch number cannot be obtained. No further information is expected.
39 2021-05-11 pain in jaw, blindness blood pressure drop; nearly fainted; chest pain; jaw pain; loss of vision; Multiple bilateral pulmon... Read more
blood pressure drop; nearly fainted; chest pain; jaw pain; loss of vision; Multiple bilateral pulmonary embolisms in my lungs; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 39 years of age), via an unspecified route of administration, administered in arm left on 04Feb2021 (Batch/Lot Number: EN6202) as 2nd dose, single for COVID-19 immunisation. Medical history included MTHFR blood clotting gene mutation. Concomitant medications included citalopram, metoprolol, omeprazole and minastein fe24, all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (lot number: EN9581) dose 1 on an unknown date (also reported as 04Feb2021) 01:00 PM in left arm for COVID-19 immunisation. The patient was not pregnant. The patient did not have any other vaccine within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 prior since vaccination. It was reported that 6 weeks after the second dose on 21Apr2021 12:00, the patient had a blood pressure drop, nearly fainted, chest pain, jaw pain, loss of vision. She went to emergency room (ER), they did tests and found multiple bilateral pulmonary embolisms in her lungs. The adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events, Eliquis (reported as 'Eloquis') blood thinners given. The patient was hospitalized for the events for one day. The outcome of the events was not recovered. Information on the batch lot/batch number has been obtained.
39 2021-05-12 sensitivity to light Pt received immunization in left arm. Immediately had a pain that went up the left side of neck and ... Read more
Pt received immunization in left arm. Immediately had a pain that went up the left side of neck and into head. She then developed a 10/10 headache, photophobia, and vertigo. Per her report "This has triggered a migraine" although it was more intense and atypical for migraine. BP was measured in right arm at 175/120. Pt had received Dose 1 with no issues. Patient was monitored for 45 minutes in the vaccine clinic over which time her BP improved slightly and her pain reduced. At the time she left clinic, she was able to ambulate, answer questions, and had no neurological deficits during the event.
39 2021-05-13 thirst 10 pm - arm near injection site was really sore, it hurt to touch or lift my arm. I was really thir... Read more
10 pm - arm near injection site was really sore, it hurt to touch or lift my arm. I was really thirsty (even after drinking lots of fluids throughout the day). I started getting a headache so took a normal dose of acetaminophen. Woke up a few times in the middle of the night, still with thirst/headache (drank another 32 oz over the course of the night). The following day continued to have a really bad headache despite taking acetaminophen throughout. I also continued to feel very thirsty/dehydrated despite drinking more water than usual (drank close to 200oz of water/ Vitamin Water). Had a sharp muscle ache on the right side of my chest that continued into the next morning. Went to bed with a slight fever. Woke up with no fever but still felt very dehydrated and had a slight headache throughout that 3rd day. Felt Mostly back to normal by the end of day 4.
39 2021-05-13 ringing in ears had mild side effects like pain in arm, chills, fever first but chills and fever continued and most... Read more
had mild side effects like pain in arm, chills, fever first but chills and fever continued and most adverse tinnitus ( like hearbeat throbbing sound in left ear).. And its continuos from last 2 days, used riteaide wax cleaning drops but no relief..
39 2021-05-13 vision blurred, blindness Blurry, loss of vision; numbness in arms & legs, extreme fatigue, loss of feeling in face
39 2021-05-14 mouth swelling Arm was very sore; Muscle ache throughout my body; Headache; Sore throat; Swelling mouth; ulcer on t... Read more
Arm was very sore; Muscle ache throughout my body; Headache; Sore throat; Swelling mouth; ulcer on tongue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 09:30 (at 39 years old, not pregnant) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient used nickel on an unspecified date. First dose received Saturday 24Apr2021 on left arm, next day (all events also reported started 28Apr2021) arm was very sore and muscle ache throughout my body and headache. Couple days later sore throat and swelling mouth and ulcer on tongue. Adverse events result in Emergency room/department or urgent care. Treatment received for the adverse event wasUrgent care and Rx. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, nasal swab on 29Apr2021, negative results, nasal swab on 01May2021, unknown results. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
39 2021-05-16 hearing loss, vision blurred Dizziness and nausea about 20 min after the vaccine. I am still dizzy and have difficulty walking, ... Read more
Dizziness and nausea about 20 min after the vaccine. I am still dizzy and have difficulty walking, balancing, eating, blurred vision and hearing (5 weeks later)
39 2021-05-16 swollen tongue 5 hours after vaccine had explosive diarrhea, 2 hours after that throat swollen and sore, tongue a b... Read more
5 hours after vaccine had explosive diarrhea, 2 hours after that throat swollen and sore, tongue a bit swollen and fevers. The following day same symptoms but also coughing fits and sever exhaustion/fatigue. Today same symptoms but also vomiting and hives/rash. I also started feeling lightheaded about 30 minutes after the vaccine but that could also just be season allergies and sinus issues, still feeling lightheaded and dizzy.
39 2021-05-17 blindness pt lost vision and had headaches. On 4/17/2021 she went to Hospital. They did multiple test. They... Read more
pt lost vision and had headaches. On 4/17/2021 she went to Hospital. They did multiple test. They did blood work and took MRI. She was diagnosed w/ subarachnoid hemorrhage. Pt was given a surgical procure on her head. She was discharged after five days to FU w/ PCP and surgeon
39 2021-05-17 mouth tingling, lacrimation increased Deviation of the corner of the mouth on the left side, watery left eye, heavy tongue, loss of streng... Read more
Deviation of the corner of the mouth on the left side, watery left eye, heavy tongue, loss of strength in the left hand and speech problems.
39 2021-05-18 deafness, ringing in ears, extreme sound sensitivity Ringing in my ears mostly right ear/Echo in ear; Very sensitive to sound; hearing loss; This is a sp... Read more
Ringing in my ears mostly right ear/Echo in ear; Very sensitive to sound; hearing loss; This is a spontaneous report from a contactable consumer (reporting for herself). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Apr2021 (Batch/Lot Number: ER8734) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Apr2021, the patient experienced ringing in her ears, mostly right ear, echo in ear, very sensitive to sound, and hearing loss. The event resulted in doctor or other healthcare professional office/clinic visit. The events were treated with anti-inflammatory ear drops. The outcome of the events recovering. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
39 2021-05-18 eye itchiness, eye swelling Exact same symptoms as with DRESS syndrome - swollen, itchy eyes; red, burning sensation on skin on ... Read more
Exact same symptoms as with DRESS syndrome - swollen, itchy eyes; red, burning sensation on skin on face
39 2021-05-19 eye itchiness, pain in jaw, bloodshot eyes, pupils dilated Severe itchy throat,constant nose irritation & sneezing,severe eye itchiness with redness of the eye... Read more
Severe itchy throat,constant nose irritation & sneezing,severe eye itchiness with redness of the eye & pupil dilated,fatigue,jaw pain.
39 2021-05-19 vision blurred About 5 minutes after she received her vaccine, she developed a posterior headache, worsening numbne... Read more
About 5 minutes after she received her vaccine, she developed a posterior headache, worsening numbness and weakness, a sensation of tightness in her throat, blurred vision, and some chest pressure. Patient was transferred to the ED for observation. She was normotensive and saturating well on room air. Neurologic exam was performed and and EKG, both were within normal limits. The patient was administered 25 mg diphenhydramine and throat tightness symptoms improved. The patient was discharged to home.
39 2021-05-20 taste impairment 5 minutes after vaccine was administered, while seated in the waiting area, I suddenly had an intens... Read more
5 minutes after vaccine was administered, while seated in the waiting area, I suddenly had an intense metallic taste in my mouth and became lightheaded. I felt like I was going to faint so I had my son get the nurse's attention. The lightheaded feeling began to pass within the next few minutes. The intense metallic flavor remained. They gave me water and gum to chew on. I waited an additional 15 minutes (totaling 30 minutes) to ensure there were no other side effects. I felt odd but safe to drive home upon leaving. The metallic taste has not subsided. It does not fade and it affects how my food tastes to me. Sweet food now has a saltiness to it, savory food has a bitter taste to it. I felt very tired the rest of the day and my arm hurt the next day, but I had no other side effects from the vaccine. The metallic taste has not faded.
39 2021-05-20 ear pain Severe head ache & severe vertigo started 8 days after vaccine. Patient had never experienced vertig... Read more
Severe head ache & severe vertigo started 8 days after vaccine. Patient had never experienced vertigo prior to this. Vertigo lasted for 4 days Severe ear pain on left side started 11 days after vaccine. Ear pain improved then returned and still remains along with head ache. Body aches and chills were also present 11 days after vaccine. Ear pain is extreme and not a symptom patient has experienced before.
39 2021-05-20 eye swelling, blindness She got her vaccine, that evening she started with ill feeling, developed a fever of 100.5, and then... Read more
She got her vaccine, that evening she started with ill feeling, developed a fever of 100.5, and then she broke out completely with a rash that she had not seen before similar to hives . She also had the soreness in the arm and felt like she was hit by a truck and it put her down for a few days. She then woke up not feeling the ill feeling. Then four days later she woke up and part of her vision was gone. She then went to the eye Dr. and was informed that she had a blood clot and an eye stroke in the right, and has to get injections in her eyeballs themselves now to resolve the issue. She will not get her sight back as the blood vessel that goes to her optic nerve has ruptured and there is blood and fluid leaking due to the stroke. She has to go through these injections every month for life, and trying to reduce the swelling to have laser surgery. She has significant swelling right now behind the optic nerve and if it does not go down then they will not be able to perform the surgery. She had previous 20/20 vision and was able to see long distances without any problems, and now she has limited vision.
39 2021-05-21 ear itchiness Itching on arms, ears, scalp, stomach and legs. twitching under skin like a spasm. Fatigue. Stoma... Read more
Itching on arms, ears, scalp, stomach and legs. twitching under skin like a spasm. Fatigue. Stomach cramps.
39 2021-05-21 ringing in ears This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient... Read more
This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172 and expiration date not provided), via an unspecified route of administration, administered in Arm Left on 07May2021 12:30 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history included exhaustion in Jan 2021, memory issues in Jan 2021, dizzy spells in Jan 2021, and COVID-19 in Jan 2021. The patient was not pregnant at time of Vaccination. The patient's concomitant medications were not reported. The patient was The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in Arm Left first dose on 15Apr2021 for COVID-19 immunization. On 07May2021 01:00, the patient experienced Painful shocking/stabbing feeling throughout entire body, tinnitus, fever, chills, body aches, headache, and covid symptoms. No treatment was given to the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
39 2021-05-22 dry mouth The day following the shot: 0400 dry mouth (drank a lot of water, that went away), temp 98.32° 0600... Read more
The day following the shot: 0400 dry mouth (drank a lot of water, that went away), temp 98.32° 0600-1200 slept (normally awake, felt fatigued) 1200-1300 felt a massive headache coming on (drank more water, ate food), temp 99.21° 1325 felt drugged, relaxed 1331 face was completely numb 1400 headache continued getting worse 2030 feeling hot - took an aspirin (Bayer 300mg) and Benadryl (25mg) and slept it off 2 days after the shot: 0545 sore arm when raising it above the shoulder, everything else was fine The face numbness was weird. I hadn't read about that symptom until I specifically searched for it after having it. But, everything is fine now.
39 2021-05-23 ear pain, vision blurred, ringing in ears, eye discomfort, ear discomfort Adverse effects started 5/12 - present. Significant increase in right ear tinnitus/fullness/pain; ne... Read more
Adverse effects started 5/12 - present. Significant increase in right ear tinnitus/fullness/pain; new left ear tinnitus; significant increase in dizziness; intermittent vertigo/nausea; eye pressure/blurring. Treatment: Have not seen a doctor yet but I am going to consult one prior to deciding to receive 2nd shot.
39 2021-05-25 taste impairment my face went numb and tingly, very sore in my joints and muscles throughout my body. It has been 4 d... Read more
my face went numb and tingly, very sore in my joints and muscles throughout my body. It has been 4 days and now i have a metallic taste in my mouth
39 2021-05-25 swollen tongue, mouth numbness Swelling and numbness of the tongue.
39 2021-05-26 loss of smell, loss of taste On 5/22 she began exhibiting congestion and lost of taste and smell. She subsequently tested positiv... Read more
On 5/22 she began exhibiting congestion and lost of taste and smell. She subsequently tested positive for Covid-19
39 2021-05-26 inability to speak patient received 1st dose on 26 jan2021,second dose on 11 feb2021; patient received 1st dose on 26 j... Read more
patient received 1st dose on 26 jan2021,second dose on 11 feb2021; patient received 1st dose on 26 jan2021,second dose on 11 feb2021; Hives; Facial swelling; Sore Arm; Lost voice indicative of airway swelling; Lost voice indicative of airway swelling; Extreme sleepiness indicative of low blood pressure; Extreme sleepiness indicative of low blood pressure; Fever - 102; This is a spontaneous report from a contactable consumer (patient). A 39 years old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 11Feb2021 at 14:00 as a 2nd dose, single dose for COVID-19 immunization. The patient's medical history included chronic urticaria, allergic to fire, ant bites, dog dander, dust mites. The patient's concomitant medications included lisdexamfetamine mesylate (VYVANSE), cetirizine (CETIRIZINE) and fexofenadine (FEXOFENADINE). Facility type vaccine was reported as Hospital. No other vaccine was administered four weeks prior to COVID-19 vaccine. On an unknown date in Dec2020, the patient underwent lab test and procedure which included covid test type Nasal Swab: Inconclusive. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 26Jan2021 at 14:00 as a 1st dose, single dose for COVID-19 immunization. On 12Feb2021 at 12:00 PM, the patient experienced sore arm, hives, lost voice indicative of airway swelling, extreme sleepiness indicative of low blood pressure, facial swelling and fever 102. The patient received 1st dose on 26 jan2021, second dose on 11 feb2021 (Inappropriate schedule of product administration)(Off label use) on an unspecified date. The patient underwent lab test and procedure post vaccination with COVID vaccine which include COVID test nasal swab: Inconclusive. The patient visited doctor or other healthcare professional office/clinic visit as result of the events. The patient took Epipen, prednisolone, antihistamines as treatment medication for the resulted events. The clinical outcome of the events were resolved on an unspecified date in 2021 and outcome of the patient received 1st dose on 26 jan2021,second dose on 11 feb2021 was unknown. Follow-up (12May2021): Follow-up attempts completed. No further information expected.
39 2021-05-26 ear pain Fever, headache, stuffy nose, nauseous, sore left ear when swallowing, diarrhea, sore breasts, start... Read more
Fever, headache, stuffy nose, nauseous, sore left ear when swallowing, diarrhea, sore breasts, started my period after finishing my regular cycle a week prior, aches, sore ankles from Monday May 24th 7pm-today Thursday May 27th. I do not have fever, diarrhea, sore ear, aches, or a stuffy nose today as of roughly 3:30 am this morning.
39 2021-05-26 pain in jaw Immediately after receiving the second dose of Pfizer on Tues May 18, I felt prickly sensations thro... Read more
Immediately after receiving the second dose of Pfizer on Tues May 18, I felt prickly sensations throughout my body. After sitting for the recommended 30 minutes (due to known allergies to previous medications), I began to feel dizzy. They monitored me in the tent for several minutes and checked my vitals, which were fine. The nurse thought I may have hyperventilated. I thought I must have just had a mild panic attack. But the attacks did not stop. Rather, the first three days post vaccine, I had several panic attacks a day, even being woken from sleep because of them. It's not fear or a racing mind but a constant racing heart, weakness, feeling faint. I feel prickly sensations and sensation of heat, which are common in panic attacks. But even after three days, they were not letting up. In addition to the attacks, I felt lightheaded, weak and extremely fatigued, even at rest. There is also constant pain and tightness in my neck and jaws. Thursday evening (May 20), I had an episode where I nearly passed out. Once I got seated, my body froze. I was unable to get my words out clearly. Instead of saying the full sentence in my head, I could only get a word or two out. Instead of being able to lift my arm to eat, I couldn't move. The episode lasted about 15-20 minutes. I had several of these episodes on Saturday, two on Sunday and one on Monday. Thinking it was purely anxiety, I reached out to my psychiatrist who prescribed Klonopin to ease the symptoms. I took 0.5mg on Friday afternoon (5/21) and 0.5mg on Saturday morning (5/22). Realizing the Klonopin was likely making my symptoms worse, I have not taken any since Saturday morning (05/22). Most of the day I am breathless, weak, feel faint doing nearly nothing. I have an hour or so a couple of times of day where I'm more functional but still have to move very slowly. Otherwise, I'm either like a zombie or unable to speak clearly, stuttering when I speak, and unable to operate without feeling faint.
39 2021-05-26 mouth tingling Cough; Throat itchiness; Tongue tingling; Anxiety; This is a spontaneous report from a non-contactab... Read more
Cough; Throat itchiness; Tongue tingling; Anxiety; This is a spontaneous report from a non-contactable other HCP reporting for a patient. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 07May2021 (Batch/Lot Number: EW0167) as a single dose (at the age of 39-years-old) for COVID-19 immunisation. The patient medical history included recent visit to the ED on 02May2021 for tongue swelling, the patient took Benadryl prior to her arrival to the ED at that time, symptoms had resolved for her then. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 on an unknown date (Lot number: ER8731) for COVID-19 immunisation. On 07May2021 the patient experienced cough, throat itchiness, tongue tingling and anxiety. The clinical course is as follows: The patient received the second dose of bnt162b2 on 07May2021. During her 30 minute waiting period after the injection, the patient began to experience cough, throat itchiness, tongue tingling. She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Follow up response to treatment: good. The patient was transported to ED by POV. The Differential Diagnosis was reported as: Differential Diagnosis: Systemic reaction (headache, itching, tachycardia, hypoglycemia, hypotension, generalized rash). The patient had stable and improving symptoms. The reporter stated: Certainly anxiety may be a factor playing into this but recommended that she seek emergency care for observation and follow up with her primary care along with allergist to look into her two reactions that she has had this week. Therapeutic measures were taken as a result of the event and included unspecified treatments. The clinical outcome of the events cough, throat itchiness, tongue tingling and anxiety were unknown. No follow-up attempts are possible. No further information is expected.
39 2021-05-26 photosensitivity reaction, pain in jaw, ear pain This is a spontaneous report from a contactable Other HCP (patient, self-reported). A 39-year-old fe... Read more
This is a spontaneous report from a contactable Other HCP (patient, self-reported). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EL8982 and expiry date was not reported), via intramuscularly, in Arm Left, on 25Jan2021 at 04:45 PM, as a single dose for COVID-19 immunization at hospital. The patient received first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EK9231 and expiry date was not reported), via intramuscularly, in Arm Right, on 04Jan2021 at 04:45 PM, as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included known allergies: mushrooms, Levaquin and cipro, hypertension, and thyroid cancer. The patient received medications Amlodipine, Levothyroxine, and fenofibrate in two weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient reported that in first 36 hrs, she was fine but by 06Feb2021 at 06:00 AM, she had the worst headache ever focused on her left temple. She happened to have an eye exam scheduled for that day and was told that her IOP was 21 in her left eye. She experienced photosensitivity for the following 2 days. Then she ended up in the ER from the headache and pressure she felt in her eye. Her blood pressure was 162/125. She was now 11 days post vaccine and currently still had a headache and experiencing light sensitivity focused in her left temple into her scalp and now had inner ear pain and jaw pain. At times, she felt short of breath as well. The events resulted in emergency room/department or urgent care. The patient received cocktail Compazine, Benadryl and Tylenol as treatment for the event headache. The patient also received unknown treatment for other events. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
39 2021-05-27 deafness, ear discomfort, ringing in ears Systemic: claims "loss of hearing, ringing, popping in right ear along with numbness in face-Medium,... Read more
Systemic: claims "loss of hearing, ringing, popping in right ear along with numbness in face-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: pt did not directly contact pharmacy-she filled out survey from a receipt-tried to follow up twice with pt but pt did not call back
39 2021-05-27 lacrimation increased Client arrived on 5/27/21 to the Health Center to get his second dose of Pfizer. Client reports that... Read more
Client arrived on 5/27/21 to the Health Center to get his second dose of Pfizer. Client reports that after her first dose on 5/6/21 of Pfizer lot #EW0179 she experienced itchy throat on only the left side, runny nostril on the left side and watery left eye 5 hours after receiving dose. Client reports she was vaccinated on the left arm. Client reports it resolved on its own after 4 days. Client approved lead PHN to administer 2nd dose with a 30 minute wait and no reaction occurred.
39 2021-05-27 lip swelling, mouth tingling Pt. arrived for first Pfizer vaccine, pt. alerted staff to anaphylaxis risk to bees and trees but st... Read more
Pt. arrived for first Pfizer vaccine, pt. alerted staff to anaphylaxis risk to bees and trees but stated she has never had an adverse reaction to vaccinations. Pt. has not used her epi pen in 10 years. Approx 10 minutes into observation pt. complains of lip tingling, swollen lips and states "half of face is swollen". EMS contacted and vital signs stable except for elevated blood pressure. Pt. given 25mg Benadryl and water. Second dose of Benadryl 25mg given at 1733. Pt. educated to seek medical attention if reaction increases. Cleared by EMS, pt. exited facility in stable condition with partner.
39 2021-05-27 mouth tingling, feeling of choking After 5-10 minutes. I started to feel tingling around my mouth and throat. Tingling in my chest, tro... Read more
After 5-10 minutes. I started to feel tingling around my mouth and throat. Tingling in my chest, trouble breathing. After sitting there for an hour my heart rate was evaluated 100 beats/min. My temperature and blood pressure was high. I started to feel dizzy. I felt I was having an allergic reaction. My oxygen was low.
39 2021-05-31 ear pain Ear ache in left ear, same side vaccine was given.
39 2021-05-31 ringing in ears Throbbing in head and vibrating sound in head
39 2021-06-01 ear swelling, ear pain Shingles; Diagnosed May 30, 2021, by Dr. Vesicular eruption on forehead, above left eye. Pain and s... Read more
Shingles; Diagnosed May 30, 2021, by Dr. Vesicular eruption on forehead, above left eye. Pain and swelling around left ear and left side of neck. Treatment: Seven-day course of antiviral medication (Valacyclovir): 600mg ibuprofen tablets as needed for pain; Hydrocodone-acetemin (Norco) for pain at night in order to sleep
39 2021-06-01 ringing in ears 10 hours after injection I had a short ringing in right ear first, then about 10 minutes later ringi... Read more
10 hours after injection I had a short ringing in right ear first, then about 10 minutes later ringing inert ear and it lasted for less than 30 seconds for both ears. Tenderness in arm at injection area about 8 hours after shot. Slight headache 10 hours after injection.
39 2021-06-06 swollen tongue Within 10 minutes I had the following symptoms: Swelling in tongue, especially the back of the tongu... Read more
Within 10 minutes I had the following symptoms: Swelling in tongue, especially the back of the tongue; Swelling and tingling sensation in throat; Flushing and swelling in face; Dizziness; tingling in arms, fingers, legs; Mild wheezing; Rapid heart rate and heart palpitations; high blood pressure. Treated with liquid Benadryl, and monitored for 2 hours. Released to go home - taking liquid benadryl every 6 hours for the rest of the day and the following day. Discontinue and see if anymore allergic reaction - did this and symptoms were gone.
39 2021-06-06 ringing in ears tinnitus It was more severe some days ago. Now, it is better.
39 2021-06-07 mouth pain, swollen tongue, dry mouth Experiencing swelling of her soft tissue palate at the back of her throat/swelling where her soft ti... Read more
Experiencing swelling of her soft tissue palate at the back of her throat/swelling where her soft tissue palate gets swollen; She can't swallow; The roof of mouth also feels dry and sticky and achy; The roof of mouth also feels dry and sticky and achy; The roof of mouth also feels dry and sticky and achy; She is muscle pain at the left back side of her mouth; The nerves start getting crazy; back of her tongue feels like it swells; Feels like she's gagging; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration in Arm Left on 18Mar2021 at 11:30(at the age of 39 years old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included , ankylosing spondylitis from 2020 and ongoing, ongoing autoimmune thyroiditis(Hashimoto) diagnosed after her second baby, she was 6 so maybe 5 years ago , cardiac disorder from an unknown date and states her mom has a heart condition and they tested her and her heart's good. The patient concomitant medications were not reported. The historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration in Arm Left on 26Feb2021 at 14:00 as single dose for COVID-19 immunization (she reported as, she knows it was close to the expiration because she got in at the last minute. It was probably the same day, the expiration. the first one was the same day expiration by 1700), flu vaccine (FLU VACCINE VII) 6.5 to 7 years ago(she would have been 34 year old) and she get Guillain-Barre and she just felt numbness, and she cut her hand open by accident a week after the first shot and got tetatnus shot (TETANUS VACCINE) on right arm on 04Mar2021 for immunization. The patient experienced as, experiencing swelling of her soft tissue palate at the back of her throat/swelling where her soft tissue palate gets swollen, she can't swallow, the roof of mouth also feels dry and sticky and achy, she is muscle pain at the left back side of her mouth, the nerves start getting crazy, back of her tongue feels like it swells, feels like she's gagging on an unspecified date on May2021. Reporter reported as, she has been experiencing swelling of her soft tissue palate at the back of her throat which started 3 weeks ago. She said that she feels like she can't swallow, it comes and goes and has been in the ER multiple times because of this. The roof of mouth also feels dry and sticky and achy. She has muscle pain at the left back side of her mouth. She enquired regarding reports on this and as to how long she will be experiencing this. She was taking Pfizer COVID vaccine as she got very paranoid, they instilled a lot of fear, she has a lot of autoimmune diseases too. She is just wondering if Pfizer has had any other people with similar symptoms to what she had after the second vaccine in March. She just started getting some insane symptoms in her mouth. she's been to the hospital 3 times with swelling where her soft tissue palate gets swollen and the nerves start getting crazy. She wasn't sure in the beginning if it could be tied to the vaccine, but from her last three hospital visits they are kind of questioning it, its kind of an unexplained reaction. It started where she felt like she couldn't swallow so they ran tests, they thought maybe it was strep throat and everything got cleared. It was nothing viral, nothing medically they could find. They could see the swelling, but theres no reason for it. The back of her tongue feels like it swells feels like she's gagging. It swells then it goes down. It gets worse then it's go back down. It's not getting better, but progressively gets worse then stabilizes then worse again. It just won't go away. She was a little skeptical of the Covid shot as she had flu shot which she did get Guillain-Barre. She was told it was safe. She was tested for strep probably 5 days after her symptoms started. She also got a Covid swab too because they didn't know what it was. They tested her for everything, viral, bacterial, Covid, strep, and everything came back negative. They are kind of puzzled, she's having symptoms, they come and go and it drives her to the emergency room because of the swelling in the soft tissue in her throat. She did read online there is some people with the vaccine have had swelling so she thought and wondered if its related.she went to the emergency room three times and she has been to an ENT, neurology, her family doctor, she has been everywhere. They discharged her every time she went to the hospital. they see the inflammation almost like it's spasming, as it gets spasms and goes down then goes up, it's very spontaneous. She went to a gastroenterologist and they did a scope and they said it was red and inflamed all the way from the back of her throat to her soft palate and all the way to her stomach, it's swollen and inflamed. She states that's why she's on steriods. They thought it could be a viral infection and the biopsy came back and it's not so they are questioning the vaccine. She states Rheumatology, they also did a test to see if her inflammation marks are high and they weren't so it shows it's not her autoimmune, it's something else. The patient underwent lab tests and procedures which included bacterial test: negative on an unspecified date, endoscopy: red and inflammed all the way from back to throat on an unspecified date , sars-cov-2 test: negative on an unspecified date on May2021, streptococcus test: negative on an unspecified date on May2021, viral test: negative on an unspecified date. Therapeutic measures were taken as a result of experiencing swelling of her soft tissue palate at the back of her throat/swelling where her soft tissue palate gets swollen. Adverse event resulted in visit to emergency room and physician office. Outcome of all the events were not recovered. Information on batch/Lot number was obtained. Further information has been requested.
39 2021-06-08 deafness, ringing in ears Tinnitus, hearing loss in left ear since two days after receiving COVID vaccine in left arm. Symptom... Read more
Tinnitus, hearing loss in left ear since two days after receiving COVID vaccine in left arm. Symptoms began on 6/3/21 and I am still experiencing symptoms today, 6/9/21.
39 2021-06-08 dry mouth Swollen underarm lymph node (ongoing) Cold sweats (lasted approx. 32 hours) Chills (lasted approx. 3... Read more
Swollen underarm lymph node (ongoing) Cold sweats (lasted approx. 32 hours) Chills (lasted approx. 32 hours) Body aches (lasted approx. 32 hours) Headache (lasted approx. 32 hours) Fatigue (lasted approx. 32 hours) Sore throat/dry mouth (lasted approx. 32 hours) Sinus congestion (lasted approx. 32 hours)
39 2021-06-08 eye pain I have been suffering from fatigue, chills, headaches, eye pain, pain in my arm (where I received th... Read more
I have been suffering from fatigue, chills, headaches, eye pain, pain in my arm (where I received the vaccine) for the past several weeks after my second dose of the Pfizer vaccine. The symptoms started the day after my second dose and continue to persist (almost a month later).
39 2021-06-08 mouth tingling my face started swelling in my lower right cheek and a little bit on my upper neck. Then within 15-2... Read more
my face started swelling in my lower right cheek and a little bit on my upper neck. Then within 15-20 min my left lower cheek started swelling slightly; right side of my tongue started to tingle; This is a spontaneous report from contactable consumers (one of them was patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: EN6260), dose 1 via an unspecified route of administration, administered in right arm on 05Mar2021 16:45 (at the age of 39-year-old) as single dose for COVID-19 immunization. The patient medical history included allergic to shellfish and iodine. Concomitant medications included levothyroxine, colecalciferol (VITAMIN D 3) and prenatal vitamins; all the concomitant medications were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 Vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 05Mar2021 16:45, the patient received first dose of the vaccine within 5 minutes her face started swell and she had tingling on her tongue. The patient stated that "I received my first does of the vaccine and within 5 min my face started swelling in my lower right cheek and a little bit on my upper neck. Then within 15-20 min my left lower cheek started swelling slightly. The right side of my tongue started to tingle as well". From the onset of the reaction to the when it started to go away was around an hour. She stated that they observed her and she didn't got into anaphylactic shock or need emergent care. She stated that she filed an online report and wanted to speak to someone in person regarding her reaction and whether or not she should get the second vaccine. She stated that her physician didn't know whether she should or not and did not give her guidance on getting the second dose. The patient wanted to know if she can get the second dose. No treatment was received for the events. Outcome of the events was reported as resolved. No follow-up attempts are needed. No further information is expected
39 2021-06-08 smell distorsion Balance issues; nauseau; alterations to sense of smell; inability to focus; constant feeling needing... Read more
Balance issues; nauseau; alterations to sense of smell; inability to focus; constant feeling needing to urinate/ inability to feel when I need to urinate; headache; joint pain; exhaustion; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp. A 39-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) , dose 1 via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 13:00 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. Relevant medical history was not reported. Concomitant medications included probiotics and ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]). The patient previously took gluten and experienced drug hypersensitivity. On 24Feb2021 the patient experienced balance issues nausea, alterations to sense of smell, inability to focus, constant feeling needing to urinate/ inability to feel when I need to urinate, headache, joint pain, exhaustion, muscle aches, all with outcome of not recovered. Therapeutic measures were taken as a result of events. No follow-up attempts are possible; no further information is expected.
39 2021-06-08 ringing in ears I had a headache and a fever developed the day of the second shot. I took Motrin that night. I exper... Read more
I had a headache and a fever developed the day of the second shot. I took Motrin that night. I experienced a lot of ear ringing, which has not gone away.
39 2021-06-08 tongue disorder, mouth tingling Pain in injection sight; Tingling and bumps on tongue; Tingling and bumps on tongue; Tiredness/Fatig... Read more
Pain in injection sight; Tingling and bumps on tongue; Tingling and bumps on tongue; Tiredness/Fatigue; This is a spontaneous report from a contactable consumer (Patient) reporting herself. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 at 11:00 (39-years age at the time of vaccination) as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient had no known allergies. Patient did not receive other vaccine in four weeks. No other medications was received in two weeks. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. It was reported that, patient has experienced pain in injection sight, tiredness/fatigue, tingling and bumps on tongue. Patient was not received any treatment for the events. The outcome of events was recovering. No follow-up attempts are possible, No further information is expected.
39 2021-06-09 taste impairment About 5 minutes after vaccine was administered, while sitting in the waiting area, I suddenly got a ... Read more
About 5 minutes after vaccine was administered, while sitting in the waiting area, I suddenly got a strong metallic taste in my mouth; felt like I was going to faint; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 17:00 (Batch/Lot Number: EW0176) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included anxiety. Concomitant medications included ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]); and ashwagandha (ASHWAGANDHA) taken for an unspecified indication, start and stop date were not reported. About 5 minutes after vaccine was administered on 30Apr2021 17:05, while sitting in the waiting area, the patient suddenly got a strong metallic taste in her mouth and felt like I was going to faint. I was given water and started to feel better. The woozy feeling subsided. I still felt as though I was in an altered state even a few hours later before that feeling subsided. The metallic taste has remained and is very strong. It has altered how foods taste to me. Even with nothing in my mouth I taste metal, as if I had a penny in my mouth. The patient did not receive treatment for the events. It was reported that the event strong metallic taste in my mouth resulted in Disability or permanent damage. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
39 2021-06-10 ringing in ears, ear discomfort constant relentless tinnitus in her right ear with accompanying ear pressure; constant relentless ti... Read more
constant relentless tinnitus in her right ear with accompanying ear pressure; constant relentless tinnitus in her right ear with accompanying ear pressure; anxiety; depression; insomnia; This is a spontaneous from a contactable nurse (patient) report. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 08May2021 09:00 (Lot Number: EP7533, at age of 39-year-old) as single dose for covid-19 immunisation. Medical history included allergy to amoxicillin and allergy to shellfish. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Apr2021 09:00 (Lot Number: ER8731, at age of 39-year-old) as single dose for covid-19 immunisation. On 09May2021 at 21:00, 36 hours after her injection she developed constant relentless tinnitus in her right ear with accompanying ear pressure. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment included prednisone 40mgs x 6 days, 20mg x1. She now (on May2021) had anxiety, depression, insomnia and was hopeless that this vaccine had ruined her entire life and had been out of work since. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Purified protein derivative (PPD) was given about 6 weeks prior to vaccine (on Mar2021) and unknown results. The patient was not pregnant. The outcome of the events was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the events(Tinnitus, Ear discomfort , Anxiety, Depression, Insomnia) and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-06-12 ear pain Received 2nd dose of Pfizer on 4-29-21. On May 1, 2021 (2 days later), started feeling dizzying and... Read more
Received 2nd dose of Pfizer on 4-29-21. On May 1, 2021 (2 days later), started feeling dizzying and light headed. This symptom continued to get worse. Slight ear pain but didn't last. Two weeks later diagnosed with inner ear infection and prescribed antibiotic and steroid. Vertigo/Swaying dizziness still persistent. Infection now gone, but still dizzy. Two ENT docs seen. Back on Prednisone and to start vestibular therapy next week and see neurologist as well. Its been over 6 weeks and still dizzy. Suspect it is Vestibular neuritis. I also was diagnosed with double eustachian tube dysfunction. Prednisone helps with ears but still dizzy. Next thursday will be 7 weeks.
39 2021-06-12 hearing loss At the first 5 minutes, I couldn't hear from my left ear and then my face was swollen and it was num... Read more
At the first 5 minutes, I couldn't hear from my left ear and then my face was swollen and it was numb. I talked to the nurse told me not to worry and to take a Claritin and go home. After 30 minutes at home, I was feeling nausea and I had migraines. After few days the doctors sent me on the emergency for a scan on my head. I still have migraines and feel nausea. Sometimes, I cannot even walk on the corner of my house. In the emergency they gave me some medicines and I was feeling better but only for one day. I wish that the nurse would send me on the hospital right away to receive a treatment and not at home.
39 2021-06-12 vision blurred Second Vaccine Location: Pharmacy. On 6/2/21 (day after 2nd dose) I vomited repeatedly throughout th... Read more
Second Vaccine Location: Pharmacy. On 6/2/21 (day after 2nd dose) I vomited repeatedly throughout the day, a total of 4 times between 9am and 5pm and was unable to keep any water or Tylenol down at all. I had a strong headache the entire day, which also brought with mental fatigue and overwhelm - I couldn't even manage to watch tv I was so ill, it was hard to concentrate, think or even focus my eyes. Around 5pm, feeling severely dehydrated and realizing the urgent cares would be closing soon I scheduled a telehealth dr. appt. with assistance. (I couldn't sit up or focus long before being overcome with nausea, and it was very hard to think.)The telehealth dr. prescribed me anti nausea medicine - Ondansetron, orally disintegrating tablet, 4mg. Told me to attempt drinking 1tsp water every 10 min. after having the medicine. After taking this medicine and also a dissolving form of tylenol you could put on your tongue, and waiting another hour I was able to begin taking sips of water and sit up. I was able to drink more water over the next few hours and finally some cold plain cereal. I thought I was finally in the clear, however I was surprised that I continued to feel nauseous the next two days and continued to need to take the medicine prescribed (from 6/2 - 6/4). My stomach was so upset from nausea and also I had cramps from beginning my menstrual cycle, but I continued to have stomach aches for the following two days (6/2-6/5). I wondered if it was a side effect from the vaccine or the anti nausea medicine. I also experienced constipation 6/2-6/12, (up to the day of writing this) something I never have an issue with. While I could say it might be related to the medicine, I don't understand why it would continue so long. It has improved somewhat gradually. What was most surprising to me after all of this is I then began to experience having a stutter when speaking, approximately once a day every day since returning to work through June 8th. (6/4 - 6/8). While this might seem minor, I have not ever experienced this in my life, so four times in four days is markedly unusual.
39 2021-06-13 deafness unilateral Sudden hearing loss in right ear.
39 2021-06-13 vision blurred It started with pain and spasms in the back and afterward difficulty breathing, blurry vision, invol... Read more
It started with pain and spasms in the back and afterward difficulty breathing, blurry vision, involuntary tremors, loss of balance, pressure and headache, dizziness, weakness, tachycardia, numbness of leg, pressure in head and seizures.
39 2021-06-14 swelling around the eyes Puffy left eye (vaccinated on left arm) first 3 days post vaccination. Spotting day 5-7 post vaccina... Read more
Puffy left eye (vaccinated on left arm) first 3 days post vaccination. Spotting day 5-7 post vaccination. Not normal to be spotting as it?s only been 1 week post last cycle. Day 7-8 (currently on day 8), puffy right eye. This is more extreme and difficult to open right eye.
39 2021-06-14 swelling of eyelid Exactly three weeks after receiving the second dose of the vaccine, I developed scleritis in my left... Read more
Exactly three weeks after receiving the second dose of the vaccine, I developed scleritis in my left eye (diagnosed by my ophthalmologist, ). After the first dose of the vaccine (so six weeks before developing scleritis), my left eyelid became swollen within two hours. The swelling went away after a day, and I did not have any issues with my left eye until three weeks after the second dose of the vaccine, when the scleritis presented in this eye.
39 2021-06-14 ringing in ears (1) Persistent ringing in both ears; has remained constant for the last 3 weeks. (2) Elevated heart... Read more
(1) Persistent ringing in both ears; has remained constant for the last 3 weeks. (2) Elevated heart rate and shortness of breath. Can't walk up stairs without having extreme heart palpitations and trouble breathing. Walked 3 miles per day without issues prior to vaccine. (3) After vaccine, I can't sleep lying down; feel like I am suffocating.
39 2021-06-15 deafness unilateral, ringing in ears fever, chills, red and itchy spots on the upper body starting the day after the second vaccination. ... Read more
fever, chills, red and itchy spots on the upper body starting the day after the second vaccination. took about 3 days. After that, echo and ringing started in the left ear. A total hearing loss in the left ear about 15 days after vaccination. Steroid use for about a month but it didn't work. Afterwards, MRI and the diagnosis is acoustic neuroma. The tumor is in vestibular nerve and 3mm.
39 2021-06-15 visual impairment The whole right side of my face went numb and vision impairment.
39 2021-06-16 dry mouth It started with tingling in my lower parts of body, restless leg symptom, stomach problems, spasms i... Read more
It started with tingling in my lower parts of body, restless leg symptom, stomach problems, spasms in my back, numbness in the toes, feeling of buzzing sensations throughout my body, dry mouth, fatigue, burning when being active, heart palpitations, brain fog, dizziness and severe headaches. I have tinnitus in the right ear and sun sensitivity.
39 2021-06-16 eye pain At the time of injection the site bled for a few minutes. For the next following week I had sharp p... Read more
At the time of injection the site bled for a few minutes. For the next following week I had sharp pains down my arm which turned into numbness that affected the fingers on my left hand. Over the course of the next month, the numbness/tingling went on to affect both of my hands and feet. At this point, my calf muscles in both legs begin to spasm. The pains are worse at night. After a month of this, I began to feel my heart racing and shortness of breath. Currently, I am experiencing additional abdominal pain and my eyes ache. None of my symptoms have resolved to date.
39 2021-06-16 ringing in ears, visual impairment, bleeding gums Day 58 of these symptoms which started approximately 1.5 hours after my shot: Flushing, severe head... Read more
Day 58 of these symptoms which started approximately 1.5 hours after my shot: Flushing, severe headaches (especially at the base of my skull), fever, weakness, confusion and brain fog, vision changes, fatigue, rapid heart rate, sweats, rash (appears more now when I eat), shortness of breath, ringing ears, severely bleeding gums, incredibly dry skin, extremely bad dizziness even while sitting still, edema, muscle aches
39 2021-06-17 loss of taste, lacrimation increased, eye pain She had no taste now, and she lost her sense of taste 2 days ago; She was not able to eat because of... Read more
She had no taste now, and she lost her sense of taste 2 days ago; She was not able to eat because of her twisted mouth; She said the COVID-19 Vaccine left her partially paralyzed in the left side of her face only/On the night of 24May2021, she couldn't close her left eye/mouth was getting "twisted; She had a terrible pain in the left-side of her head that started on the afternoon of 24May2021; On the night of 24May2021, her left eye began hurting a lot; On the night of 24May2021, her left eye had a lot of tears coming out of it.; She said she was not able to work; This is a spontaneous report from a contactable consumer. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on 24May2021 10:00 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that on 24May2021, covid-19 vaccine left her partially paralyzed in the left side of her face only, she had a terrible pain in the left-side of her head that started in the afternoon. On the night of 24May2021, her left eye began hurting a lot, her left eye had a lot of tears coming out of it and she couldn't close her left eye. On the morning of 25May2021, when she went to brush her teeth, she saw her mouth was getting "twisted". She was not able to eat because of her twisted mouth. She said she was not able to work. She had no taste now, and she lost her sense of taste 2 days ago. The events She said the COVID-19 Vaccine left her partially paralyzed in the left side of her face only was reported as serious, medically significant. The outcome of the events she said the COVID-19 vaccine left her partially paralyzed in the left side of her face only, on the night of 24May2021, her left eye began hurting a lot, on the night of 24May2021, her left eye had a lot of tears coming out of it, on the night of 24May2021, she couldn't close her left eye, on the morning of 25May2021, when she went to brush her teeth, she saw her mouth was getting "twisted", she had no taste now, and she lost her sense of taste 2 days ago and she said she was not able to work was not recovered while the outcome of the event she had a terrible pain in the left-side of her head that started on the afternoon of 24May2021 was resolved on unspecified date of 2021.
39 2021-06-17 mouth numbness Patient started to feel her "teeth and gums feel numb" at 2:35PM. Patient was given Benadryl at that... Read more
Patient started to feel her "teeth and gums feel numb" at 2:35PM. Patient was given Benadryl at that time. While being observed after given Benadryl the patient started to feel an "itchy throat" at 2:47PM. Patient was monitored for 10 more minutes. No further symptoms. Patient was allowed to leave the clinic.
39 2021-06-18 deafness As soon as I received the vaccine about 1 minute after I started with racing of heart, feeling like ... Read more
As soon as I received the vaccine about 1 minute after I started with racing of heart, feeling like my oxygen supply is being cut off, lost my hearing basically felt like I was going under with like anesthesia that lasted 5-6 minutes and then I reported it to the front staff who told me they could give me Epi pen but I refused Bc they would have had to call ambulance so they gave me 2 Benadryl I stayed for 5 more minutes then left absolutely exhausted. My hubby and I came home and went to take nap and later about 1 -2 hours after I woke up to SEVERE itching! It was horrible!!! Then I couldn?t stand much, very dizzy and unsteady on my feet. Every step I took was painful my whole body hurt and felt like I had been beaten! This went on all day then I woke up Sat morning could not walk still was in lotttt pain, so my hubby takes me to er . Long story short they provided wheelchair for me, and 45 minutes later found me bed, did chest X-ray, blood work , iv , EKG everything normal. The dr shook his head Bc he had no idea what else to do kept apologizing to me. I left the way I came basically. Sunday I was exactly same but Tuesday the limp seemed to get better and then I discovered a knot on my left upper thigh and freaked so I called my dr. My Thursday I was struggling again limping, dizzy etc. Friday I went to the dr she said muscle was very tight in my upper tight and given all my symptoms I could have Guillan Barre and she gave me handout told me what possibly look for. Symptoms are scary! She also referred me to neurologist which she said I should get a call soon. I went home couple hours later stiff when I stand, walking painful but I almost fell 2 times! Very unsteady on my feet, then I noticed pins needle feeling in my leg right arm hand goes numb now. I?m absolutely exhausted struggling to get to the bathroom! A week ago I was pretty healthy 39 year old who worked out and on the go now I struggle to walk!
39 2021-06-20 eye irritation Patient reports dizziness immediately after vaccine. Upon getting home from vaccine, reports HA, re... Read more
Patient reports dizziness immediately after vaccine. Upon getting home from vaccine, reports HA, redness/swelling of left arm. HA worsened to radiate down back. Nausea, body ache, fever over night. Next day, patient could not raise arm for swelling/pain. All of these symptoms continue but are lessening in severity. Fever continues(around 100.3). Cough, sinus drainage, burning of eyes started 5 days later and continue.
39 2021-06-21 deafness unilateral, ringing in ears ringing in left ear and some hearing loss in left ear; ringing in left ear and some hearing loss in ... Read more
ringing in left ear and some hearing loss in left ear; ringing in left ear and some hearing loss in left ear; This is a spontaneous report from a contactable other health professional (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm, on 03Jun2021 12:00 (batch/lot number: Ew0181), as 2nd dose, single, at age 39 years old, for COVID-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. Medical history included COVID-19 on an unknown date (diagnosed prior to vaccination). There were no concomitant medications. Historical vaccine included the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm, on 05May2021 10:00 (batch/lot number: Ew0173), at age 39 years old, for COVID-19 immunisation. On 04Jun2021 13:00, the patient started to have ringing in left hear and some hearing loss in left ear. No treatment was given for the events. The patient underwent laboratory tests which included SARS-CoV-2 test: Positive on an unspecified date (prior to vaccination), and COVID-19 Rapid Nasal Swab: Negative on 04Jun2021. The outcome of the events was not recovered. Follow-up attempts are needed. Further information is expected.; Sender's Comments: The patient had COVID-19 infection prior to vaccination with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). Based on information available, the reported event ringing in left hear and hearing loss in left ear was unlikely causally related to BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
39 2021-06-21 tongue discomfort, swollen tongue Swollen tongue, sores on tongue, burning sensation on tongue.
39 2021-06-22 dry mouth chills; very dry mouth; 104 fever; sleepy The temperature came down to 100 but got improved after ta... Read more
chills; very dry mouth; 104 fever; sleepy The temperature came down to 100 but got improved after taking Tylenol 3-4 times
39 2021-06-24 dry throat Hot flash; Heart rate increased; Dizzy; Nauseated; Stomach pain; throat felt hoarse; Dry throat; Ras... Read more
Hot flash; Heart rate increased; Dizzy; Nauseated; Stomach pain; throat felt hoarse; Dry throat; Rash/hives left side of face and arm,entirety of chest; Rash/hives left side of face and arm,entirety of chest; Tightening of chest; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 08Mar2021 at 10.30 (age at vaccination was 39-year-old), as single dose of COVID-19 immunisation. Medical history was not reported. Patient was allergic to sulfa medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), and Daily Vitamin (MANUFACTURER UNKNOWN) for unknown indication. On 8Mar2021 at 10.30, patient experienced hot and cold flash over entire body, heart rate increased rapidly and immediately, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest through to neck and face and Rash/hives left side of face and arm, entirety of chest. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measure was taken as a result of events hot and cold flash, heart rate increased rapidly, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest, Rash/hives and treatment included IV antihistamine (50mg Benadryl injection) Pepcid. The clinical outcome of the events hot and cold flash over entire body, heart rate increased rapidly and immediately, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest through to neck and face and Rash/hives left side of face and arm, entirety of chest was recovered with lasting effects. Information about lot/batch number cannot be obtained. No further information is expected.
39 2021-06-24 taste impairment Metalic taste in mouth; This is a spontaneous report from a contactable Other HCP (patient). This 39... Read more
Metalic taste in mouth; This is a spontaneous report from a contactable Other HCP (patient). This 39-year-old non pregnant female patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: EN5318), dose 2 intramuscularly, administered in Arm Left on 29Jan2021 23:00 as 2nd dose, single for an COVID-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing, milk allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: EL0142, Expiration date: unknown), dose 1 intramuscular, administered in Arm Left on 08Jan2021 12:00 PM as 1st dose, single for an COVID-19 immunisation. The patient experienced metalic taste in mouth on 02Feb2021 12:00. No treatment was received for event. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Feb2021 Nasal swap rapid test. The outcome of the event metalic taste in mouth was recovering Follow-up attempts are completed. No further information is expected.
39 2021-06-24 mouth tingling Perioral tingling, developed into burning sensation. No shortness of breath or respiratory distress... Read more
Perioral tingling, developed into burning sensation. No shortness of breath or respiratory distress. This developed about 50 minutes after her event.
39 2021-06-24 mouth tingling It was a bizarre feeling; my lips and tongue were tingling for about 4 days; started to feel itchy ... Read more
It was a bizarre feeling; my lips and tongue were tingling for about 4 days; started to feel itchy on back, foot, eyelids, and inside of her ears/feel itchy and the itching moves around my body; like bugs were crawling on my skin; This is a spontaneous report from a contactable consumer or other non-health care professional. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 17:45 (at the age of 39 years old) (Batch/Lot Number: ER8727) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she received her 1st Pfizer Vaccine dose on 22Mar21 17:30 pm. Around10pm that night she felt itchy on her back then it moved to her foot and the itching moves around her body, like bugs were crawling on her skin all over her body, it was all day long, 24/7. It was a bizarre feeling. And she explains that it was irritating. Then Tuesday evening, on 23Mar2201, her lips and tongue were tingling for about 4 days. She clarifies that her throat did not swell up, itch, or anything, her lips and tongue were just tingling. The patient enquired if this is a normal side effect and she still get her 2nd vaccine dose and she mentioned that she has never had reactions to vaccines or medications before. Patient states that there is not a whole lot of information about the itching. She saw information on the Covid rash, but her biggest fear was the lips and tongue tingling. Her only concern is that her allergic reaction is going to be worse with the second dose. If the reaction is not going to be worse, she will get the second one which was scheduled on 16Apr2021and will deal with the itching and tingling. Patient states that she thought maybe she was going crazy, but then she researched more and found that it was a reaction according to Pfizer's literature, it is known as pruritus. The literature did not specify if she should get the second one and wants to make sure if based on what Pfizer has seen, she's not going to get worse with the second dose. The patient reports she is still itching, the itching has improved, but it is still there very slightly. She explains that on Thursday or Friday, it was the worst, but it has been subsiding since then. She had most of the tingling of the lips and tongue then too. Since then, it's pretty much gone away, there is a little itch and tingling here and there, but nothing like what it was. She tried Benadryl and it didn't seem to do anything. The patient explains that she took one and it wasn't really working so she took another one a couple hours later, and that didn't seem to help. She didn't take any other after that because she didn't want to keep taking them if they weren't going to help. No other vaccines were administered on Same Date of the Pfizer Suspect. No adverse events required visit to emergency room or physician office. Prior vaccination there was no adverse events. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.
39 2021-06-24 swollen tongue At about 2am, the patient reported feeling itchy all over and had face swelling. At this point, her ... Read more
At about 2am, the patient reported feeling itchy all over and had face swelling. At this point, her tongue started to swell. She was brought to the ER where she received steroids and recovered.
39 2021-06-25 extreme sound sensitivity, double vision, vision blurred Following my first vaccine, I developed some blurry vision in left eye and upper arm weakness. A few... Read more
Following my first vaccine, I developed some blurry vision in left eye and upper arm weakness. A few days after my second vaccine, blurry and double vision occurred, significant cognitive deficits occurred that included difficulty processing information, memory problems, brain fog, and severe fatigue. This was associated with a headache and dizziness/lightheaded and I lost fine motor control in my upper extremities. Sound sensitivity was very prevalent. Symptoms lasted about 6-8 weeks and were so severe I was unable to drive or work for about 2-3 weeks. I continue to have lingering symptoms but would say they are 90% resolved.
39 2021-06-27 ringing in ears Right side ear completely numb. Tissues surrounding ear including face, neck and head above and behi... Read more
Right side ear completely numb. Tissues surrounding ear including face, neck and head above and behind ear completely numb. Sudden onset ringing in both ears.
39 2021-06-28 deafness At the first 5 minutes, I couldn't hear from my left ear and then my face was swollen and it was num... Read more
At the first 5 minutes, I couldn't hear from my left ear and then my face was swollen and it was numb.; At the first 5 minutes, I couldn't hear from my left ear and then my face was swollen and it was numb.; At the first 5 minutes, I couldn't hear from my left ear and then my face was swollen and it was numb.; After 30 minutes at home, I was feeling nausea and I had migraines. After few days the doctors sent me on the emergency for a scan on my head. I still have migraines and feel nausea; After 30 minutes at home, I was feeling nausea and I had migraines. After few days the doctors sent me on the emergency for a scan on my head. I still have migraines and feel nausea; I cannot even walk on the corner of my house; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 11May2021 (at age of 39 years old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine in four weeks. The case Serious was reported as No. At the first 5 minutes, patient couldn't hear from left ear and then face was swollen and it was numb. Patient talked to the nurse in the Community Center and she told patient not to worry and to take a Claritin and go home. After 30 minutes at home, patient was feeling nausea and had migraines. After few days the doctors sent patient on the emergency for a scan on head. Patient still have migraines and feel nausea. Sometimes, patient cannot even walk on the corner of house. In the emergency they gave patient some medicines and patient was feeling better but only for one day. Patient wish that the nurse would send her on the hospital right away to receive a treatment and not at home. All events started on 11May2021. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received (They gave patient medicines in the emergency room). The outcome of the events was Not recovered.
39 2021-06-30 permanent deafness, ringing in ears Patient had significant impairment of daily activities. She had dizziness random episodes while driv... Read more
Patient had significant impairment of daily activities. She had dizziness random episodes while driving, sitting, which were not positional; mild SN hearing loss; tinnitus; Dizziness; Fatigue; arm hurt; she was feeling weird; This is a spontaneous report from a contactable physician (patient). This physician reported in response to HCP letter sent via email follow that included: This 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0167) via intramuscular route in right deltoid on 30Apr2021 at 16:45 on a Friday (at the age of 39-year-old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. No pertinent family history was reported. She had no other vaccinations that day or in the four weeks prior. She did not start new medications. The patient experienced dizziness on 30Apr2021, deafness, tinnitus in May2021, fatigue, pain in extremity, she was feeling weird, loss of personal independence in daily activities on an unspecified date. Reporter called as patient who said that she was calling about the Pfizer COVID-19 vaccine because she took the first dose the 30Apr2021 and felt dizzy within 10-15-minute period, so she stood there a few minutes or whatever and then came home, and then she was still having dizziness. She said that the dizziness was not when she was moving, it was when was sitting doing work, she felts dizzy and felts fatigued. She said she was going for testing, but the reason she was calling was her second dose was scheduled for Friday and she did not think she would be able to take it then, so she would like to know how did this work. She said that they would be doing blood work and a brain MRI or something, she had an appointment with a neurologist, and she did not want to take it with the testing, without the results. Reporter said that it was given at a State government site, she set up her appointment through a website. She asked if she needs to call them to tell them she was not coming for a second dose and wants to ask if she would be able to get her second dose after the time when she knows if she was normal to get it. Reporter said her dizziness began before 5:00PM, she was feeling weird and dizzy so they put ice packs on her head for a few minutes and it was no good, she thought this was not good, it was also hot there so maybe there was something to do with it, and they said wait 15 minutes so she sat there, then slowly came home. She says she thought maybe it would go away. She says this was the main thing, her arm was also hurting, but this is normal she guesses everyone had that. She says her arm hurt for two days and then was fine after that. She says her dizziness or fatigue she did not take anything for, she did not know what to do, she thought maybe water would help. Patient had dizziness immediately after vaccine and had been persisting every day. Tinnitus started 2 weeks later with mild sensorineural hearing loss on audiology testing. No prior medical issues. Labs, MRI without contrast were normal VNG testing from ENT pending. MRI with contrast internal auditory canal pending. Patient had significant impairment of daily activities. She had dizziness random episodes while driving, sitting, which were not positional. Lab data was normal, MRI was normal. VNG test from ENT and MRI IAC with contrast was pending. Adverse event was resulted in physician office visit. Ice packs treatment received for event feeling abnormal and dizziness. Reporter said she looked it up online and it said you could get the second dose of the vaccine up to 28 days or 9 weeks or something like that, she just wanted to know if she could get it at a later date if everything was normal, like her labs or everything. Seriousness criteria was reported as persistent /significant disability/incapacity for dizziness, tinnitus and mild SN hearing loss. Reporter consider the Pfizer product had a causal effect to the adverse event. The outcome of event deafness, tinnitus, dizziness was not resolved and for rest of events was unknown. No follow-up attempts are possible. No further information is expected. Follow-up (15Jun2021): This is a spontaneous follow-up report from a contactable physician (patient). This physician reported in response to HCP letter sent via email follow that includes: Lab data was updated. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Sensorineural hearing loss,dizziness,tinnitus and Activities of daily living impaired cannot be totally excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-06-30 lip swelling tightness in chest; Swelling of lips and cheeks; Swelling of lips and cheeks; This is a spontaneous ... Read more
tightness in chest; Swelling of lips and cheeks; Swelling of lips and cheeks; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). This 39-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: not reported, Expiry date: Unknown) via an unspecified route of administration in Arm Left on an unspecified date (Age at vaccination 39 years) as dose 1, single for COVID-19 immunisation. Medical history included allergies to medications, food, or other products Penicillin and shellfish. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Concomitant medication(s) included metformin (METFORMIN) and pantoprazole (PANTOPRAZOLE). Patient was not pregnant at the time of vaccination. On 03Feb2021 08:00 PM, the patient experienced tightness in chest, swelling of lips and cheeks. Patient was received Benadryl as treatment for events. The clinical outcome of all events were recovered on an unspecified date in Feb2021. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
39 2021-06-30 visual impairment On 6/4/21 I noticed the appearance of many black dots and black squiggly lines in both of my eyes, w... Read more
On 6/4/21 I noticed the appearance of many black dots and black squiggly lines in both of my eyes, with the left eye being worse. I have never experienced this problem previously. I continue to experience this, and it appears that the number of black lines and dots may be increasing or remaining constant.
39 2021-07-01 ear pain Went from 125 down to 108 during, it was hard for me to eat I keep laying down; weight loss; Sinusi... Read more
Went from 125 down to 108 during, it was hard for me to eat I keep laying down; weight loss; Sinusitis; Really bad dreams; Not been able to like think straight; Tired; Sneezing; I had changes in my bowel like I normally went like once a day and I was going like 2 to 3 time; Sick; Bruising on my legs; I was feeling like someone was kicking me or and that's being continuing and my legs are just literally all bruised up, it started on my arms; Felt a little pain in my wrist, like my vein was like bulging like wrist was having bulging pain which was kind of like tendon, there was a bruise about the size of a quarter on my left; Nauseous; Not feeling well; Ear ache; I was actually like dry breathing because whenever there was draining from my nose down my throat, it's hardening; I was actually like dry breathing because whenever there was draining from my nose down my throat, it's hardening; This is a spontaneous report from a contactable consumer reporting for herself. A 39-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not provided), via an unspecified route of administration on 09Apr2021 at 15:00 into left side as single dose (at the age of 39 year-old) for COVID-19 immunization. The patient had received ondansetron (ZOFRAN), via an unspecified route of administration on an unspecified date, batch/lot number and dose were not reported for an unspecified indication. The patient previously took first dose of bnt162b2, solution for injection (Batch/Lot Number: not provided), via an unspecified route of administration in left side on unknown date for COVID-19 immunization and the patient had slight nausea sort of that for couple of hours. The patient medical history was not reported. Concomitant medication(s) included omeprazole (PROTONIX); quetiapine fumarate (SEROQUEL); bupropion hydrochloride (WELLBUTRIN); meloxicam; budesonide (NASOCORT); diphenhydramine hydrochloride (BENADRYL); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); propranolol; and metoprolol. The patient did not administer any vaccine 4 weeks prior to the COVID 19 Vaccine. Patient stated that, she didn't remember when she received the first one but the second dose she received on April 9th and received that one at work. She got to have that card in her purse because it's important, but it looks like she has, will give on some other time. Before the Pfizer vaccine, the patient was 125 on 22Apr. She also takes Propranolol and that's 'PRN'. And she also takes, it's also the heart medicine, it's Metoprolol, and that's 'PRN', that's a longer acting one, so she only take either one or the other (further not clarified). On an unknown date in 2021, after the second dose of the vaccine, about couple of hours she was nauseous like really nauseous. She had really bad dreams of like more than she has now still have that. And not been able to like think straight and like find words and she really honestly wouldn't have been able to even report her side effect because she couldn't even, so then she was tired, just like not feeling well and just exhausted all the time also she got up like nausea and then developed sinusitis and didn't know if that was like during that weekend or the following week but with the nausea like after like Zofran didn't help with this kind of nausea and so she was like maybe she have something wrong like with her sinuses or something. It was pollen season here and so she was taking allergy medication (unspecified medicine) and she was trying to avoid being outside where the pollen was and then she got an allergy test done recently and she was not allergic to anything. She has been tested with ear, nose, throat (ENT) and he did a Computed Tomography Scan (CT) and had fluid. The physician put her on 3 different types of antibiotics (unspecified medication) but nothing worked still have sinusitis, but the nausea was gone but this was like 3 months of being like this. And like most in her ear it's like an earache and he said that like when he was looking in there, looks better now but it's still like it's irritated but the fluid was draining but still have like she was sneezing and blowing her nose and just all this like constantly. And he sent her to a GI doctor because she was actually like dry breathing because whenever there was draining from her nose down my throat, it's hardening and so she got that checked out and had changes in her bowel like she normally went like once a day and she was going like 2 to 3 time. So, she has an endoscopy and colonoscopy done, everything came back normal. They did like, they took like few samples of something not, no problem or anything just a few samples just to see and everything came back normal, all her bloodwork came back normal, and she was checked for celiac and her thyroid and her everything came back normal but during that time she went from 125 down to 108 during like month period basically month and a half would say, and she was slowly gaining it back. But it was hard for her to eat because she was nauseous like kept laying down and then, so she was slowly gaining it back and she was feeling like she was 111 now but that was a weight loss suddenly. There's one that's kind of very disturbing, so the next morning woke up after the Pfizer and she was definitely sick but noticed she had bruising on her legs from an unknown origin like she was feeling like someone was kicking her or and that's being continuing and her legs were just literally all bruised up, her arm, like it started on her arms last week and actually like for the first time last night she witness that was happening and just felt a little pain in her wrist slight and her vein was like bulging like wrist was having bulging pain which was kind of like tendon and that was it and woke up and there was a bruise about the size of a quarter on her left and was and that's the first time that she has actually realized that she was getting one because she woke up this morning and just pressed on that spot because she knew it was the on because it hurts. But she had never actually felt the pain and then went to sleep and then woke up and it was like that, but she can't, her primary care they don't have a 'dermatologist' appointment till 22Jun2021. So, she was going to try to find one around here, but it meant this all started right after the vaccine. The patient received antibiotics as a treatment drug for the events, she thinks the first one was like 'CIVAX' or something. The outcome of the event nausea was resolved on unknown date in 2021, the event weight loss was resolving, and for other events the outcome was unknown. Information on the lot/batch number has been requested.
39 2021-07-01 mouth discomfort Fell on the floor and could not get herself up; Felt a shock; Puking and throwing up; Headache; Dizz... Read more
Fell on the floor and could not get herself up; Felt a shock; Puking and throwing up; Headache; Dizziness and could not get self up; Feeling like throwing up; Tightening of the lips; stomach was so painful; Unable to eat; Feeling so weak; Fever; Feeling so tired; Lost a lot of weight; She could not do anything; GI issues like feeling like things in her stomach and not feeling comfortable at all.; She was out of breath from the puking.; Not constipation but a sharp pain.; She does fasting and does not have an appetite; This is a spontaneous report from Other HCP (Nurse assistant; patient herself). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0186; Expiration Date: 31Aug2021) via an unspecified route of administration, administered in Arm Left on 08Jun2021 as single dose for COVID-19 immunization. Medical history included vitamin D from an unknown date and unknown if ongoing she used to take Vitamin D, accident from 2020 to an unknown date She states there was one time she had an accident and took a baby aspirin. History: Caller used to take supplement but not she did not, she used to take Vitamin D which was a supplement she takes every day like a Vitamin D and a women's pill and she used to take a fish pill but since this time she was not taking anything because she did not want anything that would be contraindication. Caller did not clarify statement or provide any additional details. She states there was one time she had an accident and took a baby aspirin but she did not take it anymore. Caller confirmed she was not taking these at time of vaccination and that her accident occurred prior to the vaccine. Caller added she was not allergic to anything, she had never reported an allergic reaction, and any medication she did not have anything she feels she was allergic to. She was good. Her health was good. Patient had not any other history and products. The patient's concomitant medications were not reported. It was reported that, she received her first injection on 08Jun2021 and she felt like that night and the whole day she threw up, had some puking and stomach, heavy headache, and a lot of dizziness. She called back her husband and her husband called back because she could not do anything. She had a headache, dizziness, fell on the floor and could not get herself up. Caller added that she started feeling like throwing up and her lips would tighten up and her stomach was so painful she has not been able to eat and has been throwing up which is a problem. Right now, she had one week without eating well. She feels like she have to go to the bathroom or like her stomach was upset and she has to throw up instead of having a BM. She had a headache and was feeling so tired and like a headache. She decided to call to see if Pfizer had experienced something like this because of how her stomach was acting. Caller was asked for clarification as she was speaking fast and states she was having GI issues like feeling like things in her stomach and not feeling comfortable at all. Caller stated that night they called 911 because it was serious and was told to take tylenol and she just had been taking tylenol and drinking water for her headache. Caller stated that she was continuing that thing - she was feeling fever and wanted to know. They were taking her temperature and it was 98 points and she was concerned about her fever. Caller stated that they told her husband to give her water and rest which did not work. She did not call because she was so weak and she usually has a good appetite but she did not have an appetite. Caller got her injection at this hospital and this was where she has her primary. Caller did not provide any additional details. Her stomach was hurting, she could not eat anything it was so terrible. Puking and throwing up: first of all, that day, when she went for her vaccine she went to come from work in the morning at 9:45 and went for the injection and they said it was horrible, she felt dizziness, she was sleepy the whole night so she thought she was sleeping like she felt the need to sleep and fell asleep immediately at 11 so that night she was feeling dizzy and weak. She was weak and dizzy and because she was sleepy she woke up around 7 in the evening to get ready for work and that was when she woke up. She fell on the floor, felt a shock and a fall. She started throwing up and her husband came and picked her up because he did not want her to choke because she was sleeping down on the floor. That is when she started throwing up and he gave her a container to throw up. He gave her one to do it, but she was feeling like she could not hold anything and was puking and felt a headache pounding up and felt like everything was going around like she was feeling dizzy. Caller clarifies she does not know what it is called, everything is going around and at that time she was out of breath from the puking. She did not eat because she slept there and there was nothing to puke so she was forcing something to come out so it was just she did not have anything in her stomach to come up. She woke up, and was asleep, she did not know what happened when she went to sleep and when she woke up too. Caller did not provide clear timeline and was asked regarding if events are still occurring and she states for now, the dizziness is not now and was not coming. The headache she takes tylenol now and she takes tylenol when she feels feverish. Caller stated what led her to call Pfizer was about the stomach problems and not eating. Also, the pain that was sharp and was going and it was not constipation but a sharp pain. She did not know how she can describe it a lot, she was having troubles like a stomachache. When she ate something, like the more she eats, like a little pancake one week, he said do not eat because she did fasting and did not have an appetite. When she ate and drinks it was like drinking a lot of water, she could not even drink things she likes. Caller added she was sure she did not have Covid because of every week they get a test. The reporter seriousness for all the events was unspecified. Patient was taking tylenol for headache and fever. The patient underwent lab tests and procedures which included body temperature: 98 points on 08Jun2021, and COVID-19: negative on an unspecified date. The outcome of event dizziness and could not get self up was recovered on an unspecified date while unknown for all other events.; Sender's Comments: Based on plausible temporal relationsip the causal role of the suspect vaccine bnt162b2 cannot be excluded for reported adverse events The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
39 2021-07-01 visual impairment Immediate: Dizziness, Light headed, Drowsy, Unsteady, weak, hot and cold flashes Reported to staff: ... Read more
Immediate: Dizziness, Light headed, Drowsy, Unsteady, weak, hot and cold flashes Reported to staff: asked twice for water, chairs were limited, sat in car... due to confusion, vision issues, and above symptoms Called parents after 45 minutes: speech was slurred like a stroke symptom Remained in parking lot for 2 hours before driving home, have not driven since Upon arriving home: experienced nausea, wooziness, severe chills, breathing irregularities, sore arm Next morning: migraine, nausea, chills, stiff muscles, fatigue, total body ache, confusion, memory loss, slurred speech, dizziness, delayed speech, stuttering Continued Continued symptoms: all above symptoms, short term memory loss, difficulty with productive language, processing speed and severe impairment with focus and concentration, extreme fatigue, slurry and stuttered speech, at times no speech ability at all, extreme body pain, difficulty walking without assistance, 24/7 headache, dizziness, nausea, vision issues, muscle spasms and tightness, joint and nerve pain, chest pains, changes in menstruation, in and out of awareness, seizure like episodes, extreme weakness The Covid19 vaccine has left pt. both physically and mentally incapacitated. She is unable to work and is on disability, unable to drive or preform normal daily activities. Please See: VSAFE Survey Response Details and Pfizer Complaint dated 5-18-21
39 2021-07-02 ear discomfort enlarged lymph node in neck; intermittent hot ears with erythema. Left worse than right; mild itchi... Read more
enlarged lymph node in neck; intermittent hot ears with erythema. Left worse than right; mild itchiness to back of neck and upper back; intermittent hot ears; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 10Mar2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Patient had no medical history. Concomitant medications were not reported. The patient did not had allergy to any medications, food, or other products. The patient previously received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration in the left arm on 17Feb2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021, the patient experienced intermittent hot ears with erythema, left ear was worse than right, along with mild itchiness to back of neck and upper back. On 23Mar2021, thirteen days after injection she noted enlarged lymph node in neck and symptoms were still occurred. The patient had no other symptoms and never had this prior to the vaccine. It was unknown if the patient received any treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the intermittent hot ears with erythema, mild itchiness to back of neck and upper back and enlarged lymph node in neck was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
39 2021-07-04 blindness in both eyes Woke up next day after the 2nd dose with an extremely bad headache and 2 days later realized I went ... Read more
Woke up next day after the 2nd dose with an extremely bad headache and 2 days later realized I went completely blind in my right eye. I went to the emergency room and they gave me steroids and plasmapheresis treatments and I was still blind after being hospitalized for 2 weeks.
39 2021-07-04 swollen tongue, lip swelling On 7/4/21, my lips started swelling around 7:30pm. I did an online visit with a doctor who told me t... Read more
On 7/4/21, my lips started swelling around 7:30pm. I did an online visit with a doctor who told me to try Benadryl and Pepcid. I went to bed and slept really well. When I woke up I noticed it was still swollen and my tongue was now also swelling. I then headed to the ER. The ER put me on an IV for steroid and more Benadryl & Pepcid. The ER also prescribed an oral steroid and said continue taking the Benadryl & Pepcid.
39 2021-07-05 eye swelling, mouth swelling, swollen tongue Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (speci... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient describes symptoms of itchiness in the face, redness (like sunburn), peeling skin and puffiness. Happened with both doses of covid vaccine.
39 2021-07-07 taste disorder, taste impairment Metallic taste in mouth, odd sense of taste after
39 2021-07-08 taste impairment, taste disorder Previously report metallic taste in mouth/altered sense of taste. Additionally reactions to report: ... Read more
Previously report metallic taste in mouth/altered sense of taste. Additionally reactions to report: sharp chest pain (resolved after several hours), skin peeling, loss of appetite, drowsiness
39 2021-07-12 taste impairment, mouth tingling, thirst heart was pounding; skin became blotchy all over; tongue was tingling; blood pressure it was 186/123... Read more
heart was pounding; skin became blotchy all over; tongue was tingling; blood pressure it was 186/123; excessive thirst; light-headedness; metal/chemical taste; extremely jittery; on edge feeling; loss of apatite; chills; fever; breathing was labored; This is a spontaneous report from a contactable consumer, the patient. A 39-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: ER 8732), via an unspecified route of administration in left arm on 26Mar2021 at 13:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included loratadine (CLARITIN) for unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was allergic to penicillin. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021, within five minutes of vaccination, the patient experienced heart pounding, skin became blotchy all over, tingling tongue, and when the technician had a check her blood pressure was found to be186/123 (her blood pressure was usually 117/over 70). The patient went to an urgent care and the doctor told, it appeared to be an allergic reaction (though not anaphylactic shock) to the vaccine and advised not to receive the second dose. The other symptoms included were excessive thirst, light-headedness, metal/ chemical taste in her mouth, extremely jittery and on edge feeling, loss of appetite, chills and fever. The following day the patient experienced laboured breathing from lightly walking around (not usual for the patient). The patient did not receive any treatment for adverse events. The clinical outcome of the events heart pounding, blotchy skin all over, tingling tongue, hypertension, excessive thirst, light headedness, taste metallic, jitteriness, depressed mood, loss of appetite, chills and fever was resolved with sequelae on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
39 2021-07-12 eye pain, eye disorder headache; headache; had issues with her left eye and it was with excruciating pain; had issues with ... Read more
headache; headache; had issues with her left eye and it was with excruciating pain; had issues with her left eye and it was with excruciating pain; hurt in the back, front and on top of her head; pressure and fluid build up in the brain; pressure and fluid build up in the brain; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer sponsored program. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0151), via an unspecified route of administration, administered in left arm on 20Apr2021 13:00 (at 39-year-old) as dose 2, single for COVID-19 immunization. Medical history included that the patient has had asthma all of her life, probably diagnosed with at age 5, the asthma was pretty much under control; patient had Covid from Mar2020. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8732), via an unspecified route of administration, administered in left arm on 30Mar2021 10:00 (at 39-year-old) as dose 1, single for COVID-19 immunization, and experienced mild headache. The patient previously has had the flu shot and might of itched just a little bit after receiving the flu shot. Nothing that would deter the patient from taking a vaccine. No shortness of breath or anything significant. The patient experienced severe headaches on 21Apr2021 after receiving the second dose. In Apr2021 she had issues with her left eye and it was with excruciating pain. The patient also had pressure and fluid build up in the brain. She hurt in the back, front and on top of her head and according to the doctor, it was because of the fluids. The patient was seeing a Neuro Ophthalmologist who put the her on Diamox medication. She was still trying to recoup. If the patient's issues did not resolve eventually the patient might have to have a shunt put in her head. The patient reported the headache to her doctor and the doctor thought the patient was having worse reaction and gave it maybe another week. The patient's headaches got worse and worse. The patient's headache was not gone. When the patient started taking Diamox, that has helped the patient reduce the pressure some, but the patient has not been headache free since all of this started. It also helped the patient when fluid was drawn off with lumbar puncture. For less than 24 hours, the patient felt pretty good, the lumbar puncture pulled the pressure off. The fluid began to build right back up. The patient has been moving from one doctor to another through all of this. The consumer stated literally everything started at the same time. When the severe headache started, it all started with the fluid. First it was just the headache when patient got the Pfizer Covid 19 Vaccine. In hindsight, everything happened very quickly and just continued to build stronger. The patient was better simply because of the medicine, but not headache free. If the Diamox medicine was taken away, the patient would be right back where she was in pain. It was completely debilitating. The patient could not let the sunlight touch her eye. The patient can't work. The outcome of event headache was not recovered; outcome of events "had issues with her left eye and it was with excruciating pain" was recovering. Outcome of the other events was unknown. Follow-up attempts are completed. No further information is expected.
39 2021-07-13 ear discomfort, eye twitching On the day after first dose of the vaccine, I started to have nerve pain going down both legs in the... Read more
On the day after first dose of the vaccine, I started to have nerve pain going down both legs in the front, from the groin area down. I also started to have a headache, and my left eye started to twitch and turned into Bell Palsy. This lasted for 3 weeks. After the second shot on 5/26/21. Lot #EW0187 I had a lot of pain on the area of vaccine on the left arm, and really bad pain under arm pit. Also, the night of the 2nd shot I developed a light rash under my breast area/upper stomach. By June 4th I had more allergic reaction around my mouth and by June 5th a had hives and rash all over my face, neck, and my scalp. By June 6th I had severe itching, rash, hives, and started swelling of my head. By June 7th I was at urgent care as the back of my head and left side was swollen, I felt like my ear was clogged and my i was in pain and itching. The Urgent Care gave me a steroid shot due to severity and prescribed pepcid, and methylprednisolone; on June 8th it spread to my check are on top, under breast, hips area, upper butt area; under stomach area. On June 14th went to see PCP, still bad rash, got more steroid pills and cream for specific areas; On June 16th had bruises all under my stomach from one side to the next. This rash and bruises lasted until July 22. On July 22nd started needles and pins on my thumbs, and fingers which i still have today that come and go. Also, on June 25th my heart started racing or skipping a beat, that comes/goes.
39 2021-07-14 tongue discomfort 3 days after my first vaccine my tongue started to feel like it was burnt. The Sunday after my first... Read more
3 days after my first vaccine my tongue started to feel like it was burnt. The Sunday after my first vaccination I woke up with the right side of my face was numb and not functioning.
39 2021-07-15 mouth numbness started out as pins and needles in arch of foot, progressed to pins and needles, body parts falling ... Read more
started out as pins and needles in arch of foot, progressed to pins and needles, body parts falling nunb for hours at time, pins and needles in arms, legs, feet, hands, nerve pain in hands , feet, around mouth, burning sensation for days on end, morphed into extreme joint pain in hands ,fingers, knees, elbows, weakness in arms- hard to raise hands over head for more then a few seconds.
39 2021-07-17 mouth tingling Development of right index finger tingling; left leg numbness; left great toe tingling/Faint tinglin... Read more
Development of right index finger tingling; left leg numbness; left great toe tingling/Faint tingling right great toe; Developed lower lip and tip of tongue tingling post vaccination; Developed lower lip and tip of tongue tingling post vaccination; This is a spontaneous report from a contactable Nurse (patient). A 39-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot Number: EL-3247), via an unspecified route of administration, administered in Arm Left on 23Jan2021 09:30 (age the age of 39-year-old) as single dose, for covid-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient sis did not receive any other vaccine in four weeks. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (MICROGESTIN FE); cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), and multivitamin. On 23Jan2021 10:00 (after receiving vaccine at 09:33 am), the patient experienced developed lower lip and tip of tongue tingling post vaccination. On 25Jan2021 20:30, the patient experienced left leg numbness and left great toe tingling/faint tingling right great toe while development of right index finger tingling on 26Jan2021. At 10:00 am, Developed lower lip and tip of tongue tingling post vaccination. Lower lip tingling resolved 5 minutes later, and tip of tongue tingling continued. Tip of tongue tingling resolved on 24Jan2021. On 25Jan2021 at 20:30 pm; developed sudden left leg numbness and left great toe tingling but at 21:00 pm left leg numbness decreased and left great toe continued to have tingling sensation. She also had faint tingling right great toe. 26Jan2021 08:00 am; left leg numbness improved but left great toe continued to tingle and Right great toe tingling was intermittent. On 26Jan2021, she had new development of right index finger intermittent tingling but at 10:00; Left leg numbness was resolved. As of 27Jan2021, she remained with intermittent left and right great toe tingling and right index finger tingling. In week of 08Feb, the above remaining symptoms were resolved. The adverse events resulted into doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The outcome of the event Tingling lips was resolved on an unspecified date in 2021, Tingling tongue resolved on 24Jan2021, numbness in leg resolved on 26Jan2021; and left great toe tingling/Faint tingling right great toe and development of right index finger tingling resolved on 08Feb2021. No follow-up attempts are possible. No further information is expected.
39 2021-07-19 taste impairment Metallic taste; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old... Read more
Metallic taste; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 10:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic cough. The patient has pineapple allergy. The concomitant medications not included. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 01Apr2021 at 10:30, almost immediately after vaccine was administered the patient experienced metallic taste in the mouth. The patient did not receive any treatment for the event. The clinical outcome of the event metallic taste was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
39 2021-07-19 taste disorder, smell distorsion I have had a history of migraines since I was a small child, but they have been stable for many year... Read more
I have had a history of migraines since I was a small child, but they have been stable for many years. I usually have about two migraines a month, same symptoms, usually easily controlled with Excedrin migraine. Of note, they do increase in frequency during stressful times. Shortly after receiving my vaccines, I noticed an accelerating increase in frequency and severity and significant change in symptoms with new changes in smell and taste, as well as new dizziness. I got care at urgent care and am now seeing neurology. I am now having daily migraines, for the last 4 months. They have been incredibly difficult to control, even on preventative medications. I have missed and cut back on work and activites with my family. I have never had an episode this severe
39 2021-07-21 drooling Mouth filled with foam; Hiccuped; Whole mouth was filled with a very thick, veryfoamy saliva; This i... Read more
Mouth filled with foam; Hiccuped; Whole mouth was filled with a very thick, veryfoamy saliva; This is a spontaneous report from a contactable other healthcare professional, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 02Apr2021 at 14:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 15:30, one hour after receiving the vaccine, the patient experienced mouth filled with foam, hiccuped, felt the mouth was filled with saliva and when she looked in the mirror the whole mouth was filled with a very thick, very foamy saliva. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events mouth filled with foam, hiccuped and whole mouth was filled with a very thick, very foamy saliva was resolved with lasting effects on 02Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
39 2021-07-25 eye irritation First shot - Large dark bruise for five days along with pain and heaviness in arm for 4 days. Nasty... Read more
First shot - Large dark bruise for five days along with pain and heaviness in arm for 4 days. Nasty asthma attack on day two. I hadn?t had one over a year and a half prior to the vaccine. Second shot - Shortness of breath, hives on face, swelling in arms, burning feeling in eyes, softball size purple bruise on arm, burning in right arm from tips a finger to middle of the back of the neck, severe nausea, and headache all started within approximately 10 minutes of getting the shot. I developed and ran a fever of 102 to 103 for four consecutive days starting on day two. Had to take a Motrin/Tylenol sport to try to get the fever down. The nausea, burning eyes, burning in the arms, and pain in the arms lasted approximately a week and a half. I went to the doctor three or four days in as the pharmacist was concerned I was getting cellulitis in my arm because of the symptoms. He stated I was having a very bad reaction to the vaccine and prescribed anti-nausea meds. He stated I should probably take steroids but it would counteract what the shot was trying to do. He advised me to come back if the redness in my arm got any bigger. It didn?t, but my arm had a nasty red bruise for roughly 3 to 4 weeks before it went away.
39 2021-07-27 ear pain Extremely swollen lymph nodes; moderate pain in neck/under chin; severe ear aches in both ears; Mino... Read more
Extremely swollen lymph nodes; moderate pain in neck/under chin; severe ear aches in both ears; Minor red rash on face, neck and chest; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 03Apr2021 at 17:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient was allergic to CIPRO/sulfa drugs. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 22:00 the patient experienced extremely swollen lymph nodes in neck causing moderate pain in neck/under chin. The swollen lymph nodes were causing severe ear aches in both ears. Minor red rash on face, neck and chest was also reported. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse events. The clinical outcome of the events extremely swollen lymph nodes, moderate pain in neck/under chin, aches in both ears, minor red rash on face, neck and chest were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
39 2021-07-27 mouth numbness Patient, who used to frequently consume seafood/shellfish, developed an allergy to seafood and shell... Read more
Patient, who used to frequently consume seafood/shellfish, developed an allergy to seafood and shellfish 1 day after vaccine administration. Patient reports to have consumed shrimp 1 day after receiving the vaccine. After eating the shrimp, the patient then developed a skin rash on her upper and lower extremities as well as numbness in the lips. The origin of the rash is unknown, but the patient exclaims the rash did not start on the arm in which the vaccine was injected. The patient also reports trying saltwater fish and shrimp flavored ramen soup after the vaccine on future unknown dates. She experienced the same allergic reaction (skin rash and numbness in the lips) from the seafood thereafter. Benadryl was used to combat the allergic reaction. The patient has consumed seafood/shellfish for all of her life and has never experienced any allergic reaction before vaccine administration. The patient was advised to contact an allergy specialist before consuming any seafood/shellfish in the future. Patient also reported having a son with seafood/shellfish allergy.
39 2021-07-27 smell distorsion, loss of smell, taste disorder, loss of taste 2 days after the vaccine I started to have body ache and chills. Then the following symptoms starte... Read more
2 days after the vaccine I started to have body ache and chills. Then the following symptoms started to come rapidly. Headache, shortness of breathe, fever, fatigue, loss of taste and smell. I felt like I was going to die (for lack of a more tactful description). This lasted for 3 weeks then the body aches started to disappear along with the chills, fever and shortness of breathe. About a week later the headache was gone. My taste and smell started to come back about a week after the headaches were gone but they are still not quite right. Things still don't taste like they used to or smell like they used to.
39 2021-07-27 ringing in ears I began to experience common symptoms about 24 hours after the shot. On Friday or Saturday night (4/... Read more
I began to experience common symptoms about 24 hours after the shot. On Friday or Saturday night (4/30 or 4/31) - I think it was Friday but am not sure, I began experiencing extreme chest pain and possibly esophageal pain and shortness of breath. It was difficult to breathe, the pain was so intense I was crying out and crying, I began profusely sweating, lost color and experienced ringing in my ears as I was close to passing out (had made it to the bed at this point). I asked my husband to call for an ambulance but w waited to do so. These intense pains and shortness of breath passed after about an hour. I also experienced headaches that would not go away for days. I ultimately went to an emergency walk-in clinic Sunday, May 1 and talked to them about my chest pains and headaches. They wrote off my chest/upper back pains as an anxiety attack, which I have never had in my life, and recommended a different OTC medication for the headaches which ultimately went away. I am not one to seek emergency medical care, I do not have heart or anxiety problems but the chest and upper back pains were excruciating but short lived. Very scary!
39 2021-07-27 eye floaters, visual impairment This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 19Mar2021 at 12:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included arthritis in the right shoulder and seasonal and pet dander allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE) from unknown dates taken for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21Mar2021 at 12:00, 2 days after the shot the patient came in from outside and her vision became dark, it had been sunny outside and this was not normal for the patient and few days after that the patient was in shower and vision was funny. On 05Apr2021, 17 days after the shot, the patient was looking at her phone screen in the evening and experienced weird splotches in vision. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events vision became dark, vision was funny and weird splotches in vision was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
39 2021-07-28 visual impairment bleed heavily with large blood clots; bleed heavily with large blood clots; chest pains; headache; h... Read more
bleed heavily with large blood clots; bleed heavily with large blood clots; chest pains; headache; hives on my neck; very sick; 2min after receiving, my throat started burning but never closed; numbness; rib pain; extremely fatigued; I recently am having some weird vision things happening; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 39-years-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 01Jul2021 at 15:00 pm (age at the vaccination was 39 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history included Ehlers Danlos. The patient did not have any known allergies. Concomitant medication the patient received within two weeks of vaccination included Amphetamine aspartate, amphetamine sulfate, dexamphetamine saccharate, dexamphetamine sulfate (ADDERALL) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Jul2021, 2 mins after receiving the vaccine, the patient's throat started burning but never closed and she took antihistamines and went to work. 48 hours later a headache started and hives on her neck, a few hours later she became very sick. The next morning she woke up to hives all over her legs and chest pains she began to bleed heavily with large blood clots. A few days later she felt better but weeks have gone by and she was still getting hives, numbness, rib pain, she hemorrhaged for eight days and that started again yesterday. She was extremely fatigued and still had hives coming and going. She was recently having some weird vision things happening. Obviously she had an immediate allergic reaction to something but now the vaccine was not meshing well with her body and symptom. She did have ehlers danlos syndrome and she realized there was just no real studies for ED patients and the vaccine. She was just hoping to let someone know what was going on. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment with EKG, epi pen, allergist appt, opt out of 2nd dose. The outcome of the events was not resolved. Information on the lot/batch number has been requested.