Pfizer

Nervous system symptom reports

Male, 26 - 39 years

Age Reported Symptoms Notes
26 2021-01-03 feeling hot his gums became discolored and turned purple/gums (both sides up and down) remain purple/discolorati... Read more
his gums became discolored and turned purple/gums (both sides up and down) remain purple/discoloration to the gums in his mouth; his mouth started hurting; feeling hot; Body aches; Fever; Pain to the gums in his mouth; muscle aches; sore throat; neck pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old male patient received the first 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 to right shoulder on 24Dec2020 11:30 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received vaccine on 24Dec2020. He experienced body aches, fever, and feeling hot with onset of about 3-4 hours after he was administered (24Dec2020). Next day (25Dec2020), his mouth started hurting, his gums became discolored and turned purple. Gums (both sides up and down) remained purple. He will be seeing a dentist. He also reported pain and discoloration to the gums in his mouth on 25Dec2020. He had been experiencing some of the regular side effects such as muscle aches, sore throat, neck pain on an unspecified date in Dec2020. Outcome of the event gum discoloration was not recovered, of the events feeling hot, generelized aching, and fever was recovered on 26Dec2020, of the event gum pain was recovering, and of the remaining events was unknown. He reported seriousness criteria as what he thinks to be medically significant at this point; that they could be medically significant. He is scheduled to receive the second dose of the product which at this point he does not plan to change. Dose change is unknown until he determines cause of these events and on what the doctor and dentist he is going to see recommend. He believes events could be caused by the vaccine. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162 and the reported events 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.
26 2021-01-04 numbness Lips swelled and went numb. Hands swelled and went numb. Rash/redness covering upper body. Hives on ... Read more
Lips swelled and went numb. Hands swelled and went numb. Rash/redness covering upper body. Hives on arms. Nasal passages clogged
26 2021-01-05 weakness Fatigue, feeling drained, fever, headache.
26 2021-01-05 flushing Immediately after vaccine administration, patient reported he felt faint. Had flushed cheeks and i... Read more
Immediately after vaccine administration, patient reported he felt faint. Had flushed cheeks and increased blood pressure. Had patient recline and was monitored for 20 minutes and felt better.
26 2021-01-05 pain in extremity, cold sweat Woke up in Cold sweat the night after receiving shot. Sore arm the following day. Tested positive fo... Read more
Woke up in Cold sweat the night after receiving shot. Sore arm the following day. Tested positive for corona virus 01/06/2021
26 2021-01-08 weakness Chills, body aches, head aches, and general energy depletion
26 2021-01-09 migraine The morning after vaccination patient developed full body muscle aches, a migraine, and fatigue. Ibu... Read more
The morning after vaccination patient developed full body muscle aches, a migraine, and fatigue. Ibuprofen was taken and symptoms lessened over 6 hours, they resolved by 01/10/2021. Patient developed severe nausea the morning after vaccination (this also occurred after the first dose), and patient vomited several times with severe retching for 30 minutes. No medication was taken and symptoms subsided after 6 hours.
26 2021-01-09 tremor, hot flush Uncontrollable shaking at 2:00 am the following morning after the vaccine. Shaking lasted about an h... Read more
Uncontrollable shaking at 2:00 am the following morning after the vaccine. Shaking lasted about an hour and from 3:00am to 6:00am hot flashes and body aches. Temperature was 100 degrees.
26 2021-01-10 weakness 1 day after vaccination I experienced muscle pain, weakness, and chills. Symptoms lasted for roughly... Read more
1 day after vaccination I experienced muscle pain, weakness, and chills. Symptoms lasted for roughly 1 day.
26 2021-01-10 pain in extremity Sore Left Arm, slight muscle aches and lightheadedness that lasted 24 hours after the day the vaccin... Read more
Sore Left Arm, slight muscle aches and lightheadedness that lasted 24 hours after the day the vaccine was given.
26 2021-01-11 flushing Employee stated he did not feel well felt flush dizzy. Employee skin was diaphoretic. Walked employe... Read more
Employee stated he did not feel well felt flush dizzy. Employee skin was diaphoretic. Walked employee to EMT station, he was able to walk without assistance. Rested on stretcher, stated he was feeling better and left the facility on his own at 1450
26 2021-01-12 slurring, tingling Facial edema, glossitis, slurred speech (non-asymmetrical) onset 1/12/2021 (time unspecified). Ting... Read more
Facial edema, glossitis, slurred speech (non-asymmetrical) onset 1/12/2021 (time unspecified). Tingling sensations to lips and tongue onset 1/13/21
26 2021-01-12 tingling At 2:34pm the patient had tingling to fingers on both hands. Vitals were taken. Observed for another... Read more
At 2:34pm the patient had tingling to fingers on both hands. Vitals were taken. Observed for another 30 min and was sent home. Notes were that right side did resolve no notes about left side.
26 2021-01-14 migraine Chills, body ache, nausea, mild fever, joint pain, fatigue, and migraine like headache.
26 2021-01-14 pain in extremity fever , extreme fatigue, sore arm, headache
26 2021-01-15 burning sensation Whole body burning sensation, chills, headache, nausea, muscle aches and general exhaustion. Improve... Read more
Whole body burning sensation, chills, headache, nausea, muscle aches and general exhaustion. Improved on second day to only muscle aches, general exhaustion, headache, and nausea. On third day, only mild muscle aches, headache, and nausea. Resolved on fourth day post-vaccine.
26 2021-01-17 weakness Symptom onset approximately 24 hours after 1st dose given. Experienced sudden onset orthostatic hypo... Read more
Symptom onset approximately 24 hours after 1st dose given. Experienced sudden onset orthostatic hypotension, weakness, and nausea for 36 hours.
26 2021-01-17 flushing After receiving COVID vaccine around 1720 and being observed post vaccination pt returned at 1807 to... Read more
After receiving COVID vaccine around 1720 and being observed post vaccination pt returned at 1807 to observation area with complaints of feeling anxious, pt noted to have flushed face and sweating. BP was 160/88 and HR 108, pt observed for additional time flushing and sweating resolved, pts BP and HR decreased to 137/73 and 73. Pt declined further evaluation in ED
26 2021-01-18 feeling hot On 1/18/2021 around 1am started feeling back pain, then started feeling hot, & then the pain went al... Read more
On 1/18/2021 around 1am started feeling back pain, then started feeling hot, & then the pain went all over my body I could still move but it was just very painful. It lasted about 12hrs.
26 2021-01-18 migraine, weakness 15th Jan-1200-nausea, migraine 16th Jan-1800-nausea, fatigue, migraine, weak body, slight dizziness ... Read more
15th Jan-1200-nausea, migraine 16th Jan-1800-nausea, fatigue, migraine, weak body, slight dizziness 17th Jan-laid down all day-spotted vision, dizziness, taste was off-threw-up x times-his words 18th Jan-same as above. night slight fever@99.3 19th Jan-woke-up, low fever, gastric reflux x 2-not feeling well
26 2021-01-18 migraine Body aches, fatigue, migraine, mild cough, nausea and vomiting.
26 2021-01-18 pain in extremity Slight chills and some body aches, mild headache, all starting at night. Sore arm at injection site ... Read more
Slight chills and some body aches, mild headache, all starting at night. Sore arm at injection site reaction. Vaccine was administered around 10am. Went to sleep and woke up with more severe headache, took Naprosyn, headache resolved. Chills and body aches were gone after sleeping. Some fatigue also present after waking up.
26 2021-01-19 tingling Tingling in arm 1 minute after injection. Rapid response observed for 30 minutes. no other interven... Read more
Tingling in arm 1 minute after injection. Rapid response observed for 30 minutes. no other intervention
26 2021-01-21 pain in extremity Sore arm after 2 hours from injection. Headache upon waking up the next morning after getting the in... Read more
Sore arm after 2 hours from injection. Headache upon waking up the next morning after getting the injection in the evening. Sleepiness/fatigue the night of injection and the day following injection.
26 2021-01-25 weakness Runny nose; tachycardia; Weakness; flu like symptoms; Sore/dry throat; Sore/dry throat; nausea; This... Read more
Runny nose; tachycardia; Weakness; flu like symptoms; Sore/dry throat; Sore/dry throat; nausea; This is a spontaneous report from a contactable nurse (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on the left arm, first dose on 18Dec2020 (lot number: EH9899) and second dose on 08Jan2021 08:15 (lot number: EL3246), both at a single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medications were not reported. Patient did not receive other vaccines in four weeks prior to vaccination. The vaccine was given at a hospital. The patient reported sore/dry throat and nausea started Sunday (03Jan2021), weakness and flu-like symptoms on Monday (04Jan2021), then runny nose and tachycardia on Tuesday (05Jan2021). No treatment was received for the events. Patient has not been tested for COVID post-vaccination. Outcome of the events was not recovered.
26 2021-01-26 weakness Subjective fever (axillary temp 98.2F), chills, generalized weakness, malaise, headache, brain fog. ... Read more
Subjective fever (axillary temp 98.2F), chills, generalized weakness, malaise, headache, brain fog. Onset 3AM, resolved by 10PM with PO Tylenol 500mg plus PO ibuprofen 800mg taken together, as well as warm soup/tea and a nap.
26 2021-01-26 muscle spasms, tingling Shivering; muscle cramps; Extreme Neck and back pain; Extreme Neck and back pain; Left armpit pain w... Read more
Shivering; muscle cramps; Extreme Neck and back pain; Extreme Neck and back pain; Left armpit pain with tinglingly sensation down left arm; Left armpit pain with tinglingly sensation down left arm; This is a spontaneous report from a contactable nurse. A 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283, expiry date not reported), via an unspecified route of administration on 11Jan2021 at a single dose in the left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient had no other vaccine in four weeks. The patient had the first dose of bnt162b2 (brand: Pfizer, lot number: Ej1685, expiry date not reported) on 21Dec2020, intramuscular in the left arm for COVID 19 immunization. On 12Jan2021, patient experienced shivering and muscle cramps the first day; extreme neck and back pain x2 days post injection. On third day post injection, patient experienced left armpit pain with tinglingly sensation down left arm. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events shivering, muscle cramps, extreme neck and back pain and left armpit pain with tinglingly sensation down left arm was unknown.
26 2021-01-30 feeling cold I felt cold then feverish with sweats. I also had full body aches and a headache. They lasted 10-12 ... Read more
I felt cold then feverish with sweats. I also had full body aches and a headache. They lasted 10-12 hours. 1000mg of tylenol helped significantly.
26 2021-01-31 pain in extremity Extremely sore arm, very tired.
26 2021-02-02 pain in extremity Extremely sore arm for entire day after injection (painful to move and use); severe headache (mornin... Read more
Extremely sore arm for entire day after injection (painful to move and use); severe headache (morning after - present, approximately 48hrs after injection).
26 2021-02-06 numbness, tingling numbness/tingling in face for 5 - 10 minutes
26 2021-02-10 unresponsive to stimuli Patient presented with puffy eyes approximately 4 minutes after vaccination. Was alert and oriented ... Read more
Patient presented with puffy eyes approximately 4 minutes after vaccination. Was alert and oriented to time, person, and place upon questioning and was able to engage in conversation. Parent (mother) of patient was present who gave patient's medical history and reported allergy to grass with similar reaction. Blood pressure was taken and found to be 150/80. Mother reported patient had not taken his blood pressure medicine yet that day but his normal is 115/70 with medication. While nurse was assessing patient's pulse (patient's pulse was WNL at 85) and other nursing staff was obtaining medication to administer if needed after assessment, patient became unresponsive to verbal commands and his upper body became limp. At 1054, a one time, single dose of 50 mg of diphenhydramine IM was given in the left deltoid. On site EMT arrived on the scene at 1055, completed assessment, and confirmed giving diphenhydramine was the best course of action. At this time, 1055, patient became responsive to verbal commands and was oriented to time, place, and person. At 1056 O2 sat was at 97%, pulse 70, and at 1100, BP was 110/70. Patient stayed for observation 30 more minutes and remained stable. Patient and parent were educated on side effects of diphenhydramine, to watch for any returning symptoms of allergic reaction throughout the day, and if/when to head to the ER. Recommended patient not receive 2nd dose of COVID vaccination.
26 2021-02-13 bell's palsy Bell's Palsy (left sided facial droop, difficulty closing left eye lid). Outpatient treatment with o... Read more
Bell's Palsy (left sided facial droop, difficulty closing left eye lid). Outpatient treatment with oral corticosteroids, valacyclovir and topical Lacrilube (eye lubricant) prescribed by ED physician and referral to primary care for follow up.
26 2021-02-13 muscle spasms Back spasms, fatigue, dizziness when standing/moving.
26 2021-02-20 cold sweat, weakness, pain in extremity, tremor 1/28 - First dose of vaccine received. Arm felt heavy, not sore. Throughout the day, fatigue gradual... Read more
1/28 - First dose of vaccine received. Arm felt heavy, not sore. Throughout the day, fatigue gradually increased. Before bed time, had cold sweats and shakes. 1/29 - woke up feeling perfectly fine. 2/17 - Second dose of vaccine. Arm felt sore and was sore two days after. From 2/18-2/20, I noticed the effects of the Cymbalta were gradually decreasing and was experiencing side effects (shocks from toe to head every step). Turns out that even with taking my regular dose of the Cymbalta, my body after 2 hours feels like I had never taken it. 2/20 - After experiencing heavy shocks, shaking, and heart racing, I went home after coming into work 3 hours later. 2/21 - Woke up today feeling dizzy, fatigued, and weak. I know that operating a motor vehicle will not be possible for me.
26 2021-03-02 feeling hot Nausea, warmth after vaccine. Initial BP, 89/51. Final BP 111/47; blood glucose 85. Drank water.
26 2021-03-02 flushing Patient stated to RN at observation that " he wants to lay down". RN stated that "she held his head"... Read more
Patient stated to RN at observation that " he wants to lay down". RN stated that "she held his head" as he experienced a syncope event. RN notified Nurse Practitioners . EMS activated. Patients assessed and found to be alert and oriented to place and person. Patient stated that he felt dizzy. Vital signs monitored and patient found to be hypotensive, diaphoretic, and flushed. Epinephrine administered X3 with vital signs monitored in between. Vital signs stabilized and patient transferred to hospital with EMS.
26 2021-03-04 feeling hot I took notes during my wait time: -6 minutes in my throat felt weird, but different than normal alle... Read more
I took notes during my wait time: -6 minutes in my throat felt weird, but different than normal allergic reactions to foods. I prepared my Epi-Pen so I have easier access at this time. -9 minutes in the sides of my tongue were slightly itchy. -11 minutes in and I felt as though the saliva in the back of my throat was thicker and I needed to clear my throat a bit more often, similar to allergic reactions. -15 minutes in, I felt my heart pound once out of beat, but my heart rhythm returned to normal immediately. Tongue itchiness also became intermittent rather than constant. -18 minutes in, overall condition improved and I felt better. -22 minutes in, my throat felt scratchy like I would if I consumed legumes (chickpeas, green peas, soy beans, etc.) but also oddly warm, which was out of the norm. No treatments needed given mild reactions. I went to work, but notified my co-workers of my reaction, so if my condition worsens they can help administer my Epi-Pen. I am reporting this at 9:21 am on 03/05/2021, roughly an hour after my first dose.
26 2021-03-05 pain in extremity, weakness On the same day after the vaccine I had a fever and no energy. The next day my arm was still sore an... Read more
On the same day after the vaccine I had a fever and no energy. The next day my arm was still sore and I felt better until around 11pm. I had a fever again of 100.4 and fatigue and dizzy ness.
26 2021-03-07 pain in extremity very painful arm; chills; extreme fatigue; Moderate prefrontal headaches; mild nausea; This is a spo... Read more
very painful arm; chills; extreme fatigue; Moderate prefrontal headaches; mild nausea; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 26-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), on the left arm, via an unspecified route of administration, on 31Jan2021 12:00 pm at single dose for COVID-19 immunization. Medical history was reported as none. The patient has no allergies. There are no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number: EL3248) on 10Jan2021 at 08:00 am on the left arm for COVID 19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications taken with 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date, 48 hours after the second dose, it was reported that the patient had very painful arm, chills, and extreme fatigue. On an unspecified date, 8 days after the second dose, the patient had moderate prefrontal headaches and mild nausea. No treatment was received for the events. The events were considered as non-serious and the events did not result in death, life-threatening condition, hospitalization, disability or congenital anomaly. The patient was tested for COVID-19 since the vaccination on 02Feb2021 via nasal swab with a negative result. The patient was vaccinated in a hospital. The outcome of the events was reported as recovering.
26 2021-03-07 pain in extremity arm very sore; her son received 6 times the amount of the vaccine dosage/overdosed 6 times the norma... Read more
arm very sore; her son received 6 times the amount of the vaccine dosage/overdosed 6 times the normal amount/over dosed him on the amount by 6 times, a huge mistake; This is a spontaneous report from a contactable consumer company CEP 2191. A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) on 04Feb2021 via an unspecified route of administration in the arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The reporter stated her son received 6 times the amount of the vaccine dosage. The patient had not administered pfizer vaccine on same date and not had prior vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine. The patient had no AE's prior vaccinations. The patient had no any illness at time of vaccination and was not diagnosed with allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient experienced her son received 6 times the amount of the vaccine dosage/overdosed 6 times the normal amount/overdosed him on the amount by 6 times, a huge mistake on 04Feb2021 and arm very sore on an unspecified date. The patient was concerned about side effects. The patient has been feeling fine and has not mentioned any issues since the overdose. The patient had no relevant test and no had any illness. 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.
26 2021-03-08 flushing, feeling of body temperature change Vision blurring, cold sweat, racing heart rate, flushing and syncope 5 minutes post-injection. EKG s... Read more
Vision blurring, cold sweat, racing heart rate, flushing and syncope 5 minutes post-injection. EKG showed ventricular arrhythmia which converted to normal sinus rhythm with regaining consciousness approximately 5 minutes later.
26 2021-03-08 numbness ten mins after shot left arm started going numb. started having chest pain, nausea, didn't feel like... Read more
ten mins after shot left arm started going numb. started having chest pain, nausea, didn't feel like himself bp started going up
26 2021-03-10 flushing, unresponsive to stimuli, feeling cold Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: COLD TO TOUCH AND SWEATING, DIFFICULTY HEARING-Mild, Systemic: Flushed / Sweating-Medium
26 2021-03-10 seizure About 30 minutes after dose he passed out and had a seizure that lasted 10 -15 seconds. This happene... Read more
About 30 minutes after dose he passed out and had a seizure that lasted 10 -15 seconds. This happened a couple times. He went to hospital had low blood pressure and oxygen. He stabilized and was released. He has a follow up appointment with his primary care doctor.
26 2021-03-10 tremor, seizure, involuntary muscle movements He began convulsing in his sleep, almost like a seizure except he woke up and became aware of what h... Read more
He began convulsing in his sleep, almost like a seizure except he woke up and became aware of what his body was doing. He could not control his body or limbs to move or stop the shaking. He did not have a fever at the time and could not determine whether or not he felt cold. The uncontrollable shaking was consistent for about ten minutes and then continued sporadically for an hour or so, though it became much more controllable. Hours later, he has more typical symptoms like a bad headache and a fever. The shaking has not come back.
26 2021-03-11 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotens... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Patient fainted, unfortunately did fall, however despite some bruises was ok. Waited for family to come to get him and was able to leave under his own power. Ambulance was called and he was checked, no issues found and did not leave with ambulance.
26 2021-03-12 difficulty speaking About 14 hours after the injection, pt developed difficulty breathing and hoarseness. Pt improved s... Read more
About 14 hours after the injection, pt developed difficulty breathing and hoarseness. Pt improved slightly after taking their symbacort & albuterol.
26 2021-03-15 numbness, tingling Two days after second shot Patient experienced: tingling/numbness in both hands; A rash to his face,... Read more
Two days after second shot Patient experienced: tingling/numbness in both hands; A rash to his face,chin and to both arms; Itching with bumps, swollen fingers and toes; Rash and swelling moves around body with elevated joint/bone pain; fevers on/off. 2/13/21- Went to Urgent Care, given Keflex with no change.2/15/21- Urgent Care second visit, Keflex stopped.2/17/21- Clinic, Benadryl & Tylenol PRN and labs done with no change in rash, Covid test negative. 2/18/21- Dermatology Appointment- Doxycycline 100mg BID, Hydroxyzine PRN, Zyrtec OT, Punchbx left ankle. 3/11/21 - No diagnosis made in Hospital or from follow-up visit with Dermatologist. Continue to have occasional area of transient redness and some numbness and tingling in hands.
26 2021-03-15 tremor, pain in extremity, muscle spasms, involuntary muscle movements On 2/13/2021, I began to experience both enhanced and new musculoskeletal and neurological symptoms ... Read more
On 2/13/2021, I began to experience both enhanced and new musculoskeletal and neurological symptoms that have not completely resolved still, today, 3/16/2021. While I had experienced some slight discomfort and pain of the b/l thumbs 2-3 weeks prior to 2/13, I began to experience increased pain up to the forearm in both arms on that day. In addition to pain, I had large muscular knots in the superior forearms, especially the right arm. The lower right arm felt extremely tight, and I was having difficulty raising the arm and gripping things. This continued for 2-3 weeks on the right arm. During that time, symptoms worsened on the left arm, while improving on the right arm. A week after the initial symptoms my left arm became worse, and I was struggling to lift objects as light as a sheet of paper. I was also having trouble typing at work, dialing the phone, and opening or closing my hand. Just over a week after symptoms began, I left work to determine a cause and solution for my issues. I also began to have tremors, extreme muscle spasms, and involuntary movements around this time for about 2-3 weeks. While the neurological symptoms have mostly subsided, still, today, 3/16/2021, I continue to deal with various inflammatory musculoskeletal symptoms affecting mostly my left arm, but also my right arm. Since yesterday, my left shoulder has begun to have pain as well, making raising my arm and reaching to the opposite side difficult due to pain. I have also had persistent popping of various joints in both arms since the initial symptoms began.
26 2021-03-17 grand mal seizure Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; Within t... Read more
Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EN5318) via an unspecified route of administration on 30Jan2021 12:45 into right arm at a single dose for COVID-19 immunisation. The patient medical history included epilepsy and cerebral palsy and known allergies is to amoxicillin. The patient had a seizure disorder, epilepsy (Lennox Gastaut Syndrome). He has an average of 1 Tonic-Clonic (Grand Mal) and 2 Series of Myoclonic Jerks a day. There is no other vaccine was administered in four weeks. There is no COVID prior to vaccination. Concomitant medications in two weeks included topiramate (TOPAMAX), lamotrigine (LAMICTAL), clobazam (ONFI), glycopyrronium bromide (CUVPOSA), potassium citrate, citric acid, calcium carbonate and colecalciferol (VITAMIN D). Within the first 24 hours(PENDING CLARIFICATION, as reported as 30Jan2021 02:45AM) of receiving the vaccine his seizure activity increased. Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks. The patient received emergency seizure medicine Klonopin. The patient did not test COVID post vaccination. The outcome of the events was recovering.
26 2021-03-18 bell's palsy Onset of Bell's Palsy two weeks post-vaccination
26 2021-03-19 numbness While in observation for 15 minute post vaccination observation period, recipient complained of dizz... Read more
While in observation for 15 minute post vaccination observation period, recipient complained of dizziness, numbness, light headed, tight chest
26 2021-03-21 pain in extremity Significant lethary, very sore arm, muscle weakness, full body achiness. Currently ongoing.
26 2021-03-22 flushing, unresponsive to stimuli Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: ANXIETY, monitored 1 hour post incident -Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Prior to injection patient fainted/syncope, and slowly made his way to the floor with assistance of RN. Pt. was \"out\" for 3-4 sec. aRevived with gentle shaking. Pt was face down taking slow breaths, patient was completely diaphoretic and lost control of his bladder. Paramedics arrived on scene with in minutes and monitored vitals. Pt reported feeling fine but embarassed and still wanted his shot. vaccine given, with paramedics present. pre-syncope rxn., due to anxiety, but fully responsive.
26 2021-03-22 seizure Patient was waiting for the 15mins post vaccine. Three minutes into waiting, patient slumps and fall... Read more
Patient was waiting for the 15mins post vaccine. Three minutes into waiting, patient slumps and falls out chair. He hit his head and turned face down, he then began to start seizing. During this time we held his head, to ensure he did not continue to hit the floor. A team was called, and the team attended to the patient. Patient's vitals were taking and he was stable. To take precaution, he was placed on oxygen to ensure he was comfortable during transfer. When picking the patient off the floor with the staff, patient began seizing once more before being transferred to the ED.
26 2021-03-23 cold sweat, feeling hot, feeling of body temperature change I have a history of insomnia, Bipolar II, and ADHD. Last night, about 10 hours after getting the vac... Read more
I have a history of insomnia, Bipolar II, and ADHD. Last night, about 10 hours after getting the vaccine, I had some insomnia. This might be unrelated, but I want to bring it up. About 18 hours after the vaccine, I started to get chills, become clammy, both hot and cold at the same time, and slight fatigue. 24 hours after my vaccine, I noticed that my headache got worse, i felt much more fatigued, and my head felt warmer.
26 2021-03-24 weakness Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Addit... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: PATIENT STARTED FEELING NAUSEATED AFTER SHOT BECAME PALE ,STUNBLED HAD DIFFICULTY BREATHING AND HE LAID DOWN X 30 MINUTES . AFTER WE CALLED 911 HE SAID HE DIDNT NEED IT BECAUSE HE HAS A REACTION AFTER EVERY IMMUNIZATION
26 2021-03-24 cold sweat, feeling cold 3/24/2021 9:59 AM VACCINE AT 9:30 AM - SYNCOPE- COLD CLAMY, VASOVAGAL RESPONSE CAME TO WITH REPONSE.... Read more
3/24/2021 9:59 AM VACCINE AT 9:30 AM - SYNCOPE- COLD CLAMY, VASOVAGAL RESPONSE CAME TO WITH REPONSE. BP TAKEN NO MEDICAL PROBLEMS.
26 2021-03-24 facial paralysis Pt. reports drooping of his left eye and left lip, which lasted a few hours, one day after receiving... Read more
Pt. reports drooping of his left eye and left lip, which lasted a few hours, one day after receiving his first dose of the COVID-19 vaccine.
26 2021-03-24 feeling cold Reported lightheadedness, feeling cold and weakness in knees.
26 2021-03-25 cold sweat Client received his second dose of Pfizer vaccine and during the post-vaccination wait period in his... Read more
Client received his second dose of Pfizer vaccine and during the post-vaccination wait period in his work car, he complained of feeling nauseous. He denied any other symptoms. Vital signs: BP=116/78; Pulse=91. He was noted to be clammy. He was evaluated by the Nurse as well as the EMT Personnel on site, and declined for 911 to be called. He made arrangements for someone to give him a ride back home, and was instructed to call 911 if the nausea did not resolve. He voiced understanding and waited in his car until he was picked up.
26 2021-03-26 feeling hot This was my second dose of the Pfizer/BioNTech COVID-19 vaccine. I took some notes during my waiting... Read more
This was my second dose of the Pfizer/BioNTech COVID-19 vaccine. I took some notes during my waiting time following my injection similar to my first dose. Information from my last report can be found using Temporary VAERS E-Report No: 334845. Of note, I did prepare for my second dose by taking Benadryl 50 mg and Airborne Immune-Boost supplements the night before my second dose, so my symptoms were not as severe as last time. 6 minutes: Mild tingling around tongue. This time all around the edges of my tongue, but a lot less bothersome than the first dose. 8 minutes: Weird. Slight itchiness under left half of tongue. Still very mild but less concerning than first dose itchiness on the left and right sides of my tongue. 18 minutes: Itchy on right side slightly, only side noticeable. 20 minutes: Mild warm feeling on left side of top of my throat. Less bothersome than time. 26 minutes: Left throat warm ness resolved, but transitioned to right side of top of my throat. 31 minute: Throat warmness overall resolved, but slightly itchy on edge of right side of my tongue. 37 minutes: Top of throat on right feels weird but not itchy. Warm maybe? 39 minutes: Weird feeling on right side of throat resolved. Symptoms more or less resolved the rest of the day, especially after second dose of Flonase @ 9:00 am. 14 hours later: About to go to bed. Feeling fatigued, similar to my first dose after working out. Took airborne and two Benadryl (25 mg each) before sleeping. 24 hours later: 03/27/2021, feeling more fatigued, groggy, mild headache (mostly at back of my head), and muscle aches around my body. 25 hours later: Groggy feeling and fatigue resolved. Possibly due to Benadryl or vaccine? 32 hours later: Majority of muscle aches resolved. Headache also resolved. Feeling mostly soreness at this point. Drank Airborne @ 10:00 am and 4:00 pm. In between drank plenty of fluids (water, cranberry juice, apple juice, milk). No fever or chills.
26 2021-03-27 tremor, weakness Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additio... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Pt was pale and stated that he felt as if he was going to pass out, Pt given orange juice and cool paper towel and monitored. Symptoms improved within 10 minutes and pt was able to leave store unaided.
26 2021-03-28 migraine, numbness, tingling Had onset of a headache about 2 hours after vaccination on Saturday, 20 March. On Tuesday 23 March, ... Read more
Had onset of a headache about 2 hours after vaccination on Saturday, 20 March. On Tuesday 23 March, at about 11 AM began having a migraine headache (had a past medical history of migraine headaches as a teenager). About 3:10 PM on Tuesday 23 March, began to have tingling and numbness in right hand (he is right-handed). Taken to ER where he could not remember his name. He was admitted and found to have four infarcts in three lobes of his left hemisphere (parietal, frontal and temporal). CT, MRI and cardiographic exams with contrast revealed a patent foramen ovale. Discharged on 40 mg Lipitor and ASA 81 mg, and referred to UCSF Neurology for followup.
26 2021-03-28 tingling Tunnel visioning Limited hearing Sweating Paresthesia of hands Nausea
26 2021-03-30 tingling pt. c/o headache, sweating, tingling. pt. went home after symptoms was resolved.
26 2021-03-31 cold sweat, feeling cold 26by/o male, c/o lightheaded ness, dizziness, buzzing in the ears, stated ?I think I passed out?. Pt... Read more
26by/o male, c/o lightheaded ness, dizziness, buzzing in the ears, stated ?I think I passed out?. Pt was pale, cold, clammy, diaphoretic but able to answer questions appropriately. PARAMEDICS came to check pt. V/S HR 51, BP 107/70, O2 sat 98%. NS BOLUS GIVEN, sent to HOSPITAL FOR FURTHER EVALUATION.
26 2021-03-31 migraine Migraine and inability to sleep starteing at about 6:00 am the next day, April 1, and continuing unt... Read more
Migraine and inability to sleep starteing at about 6:00 am the next day, April 1, and continuing until the submission at 4:00PM. Mild fever as well. Headaches so bad I can?t focus
26 2021-03-31 unresponsive to stimuli, seizure, tremor Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: patient was administered vaccine, was feeling well and walked to waiting area. patient \"lost balance\" and fell to floor, hitting his face and began bleeding from his nose and upper brow area. Technician retrieved an ice pack from pharmacy, and in the meantime, worker aided patient to sitting position, which was when patient began to seize. worker called EMS while holding patient's head steady. Patient regained consciousness and EMS arrived. Whole event lasted around 5 minutes.
26 2021-04-01 seizure, muscle spasms, weakness Patient got Shortness of breath, leg cramps, lost control on his body and seizures 2 hours after get... Read more
Patient got Shortness of breath, leg cramps, lost control on his body and seizures 2 hours after getting the vaccine and stayed for about 5 minutes. No medication or treatment was given. reported by his sister
26 2021-04-02 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
26 2021-04-03 night sweats Fatigue, lymph node swelling, night sweats and fever, chest tightness, muscle ache and pains (full b... Read more
Fatigue, lymph node swelling, night sweats and fever, chest tightness, muscle ache and pains (full body). All symptoms persistent and ongoing, beginning after second dose.
26 2021-04-04 unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild
26 2021-04-05 tingling Temporary blindness for about 5-10 minutes. I was unable to see but was conscious and eyes were comp... Read more
Temporary blindness for about 5-10 minutes. I was unable to see but was conscious and eyes were completely dilated. As a result of the inability to see, I felt panicky and my fingers and face were tingly.
26 2021-04-06 discomfort I have developed a lump above my left collarbone causing discomfort.
26 2021-04-06 feeling cold, cold sweat C/o lightheaded ness, upon assessment pt was cold, clammy, diaphoretic. Paramedics V/S HR 73, BP 11... Read more
C/o lightheaded ness, upon assessment pt was cold, clammy, diaphoretic. Paramedics V/S HR 73, BP 118/69. pt s/s resolved, able to be discharged without s/s distress.
26 2021-04-06 seizure Patient seemed to have a seizure lasting 1 minute, hitting head as he fell out of his seat. He then... Read more
Patient seemed to have a seizure lasting 1 minute, hitting head as he fell out of his seat. He then became aware of surrounding. Paramedics came and took patient to ambulance.
26 2021-04-07 weakness Low grade fever, body chills, nauseated, no energy,
26 2021-04-07 cold sweat About 10 minutes after receiving vaccination, patient started experiencing cold sweats and he felt l... Read more
About 10 minutes after receiving vaccination, patient started experiencing cold sweats and he felt like we was about to pass out. I took him into the clinic room and allowed him to lay down and began to fan him down for him to cool off. After 1-2 minutes, we put him on his back and elevated his feet. While he was laying down, I checked his blood pressure and it was low. I let him lay down for 5 more minutes and he started to feel much better and was cooled down. I slowly got him up and allowed him to sit and checked his blood pressure again. The blood pressure began to normalize. After 5 more minutes, I told him to get up and slowly walk to another chair in the room. Once he was rested there for about 5 minutes, I checked his blood pressure a 3rd time in the opposite arm and it was normal. He no longer felt the light headed feeling and was cooled off. The patient's partner then informed me that he has a fear of needles and the last time he received a vaccination about 7 years ago, the same reaction happened.
26 2021-04-07 muscle spasms, facial paralysis Loss of taste on left side of the tongue started on Sunday 04/04. This was followed by slight muscle... Read more
Loss of taste on left side of the tongue started on Sunday 04/04. This was followed by slight muscle spasms on the left side of the face (cheek and eyelid) on 04/05. On 04/06, loss of control of left side of the face started. I cannot blink fully with the left eye, and I cannot contract my left cheek fully. My smile is asymmetric and I cannot fully lift my left eyebrow. The loss of taste on left side of the tongue persists as of today 04/08. I was prescribed prednisone 20mg twice daily by my primary physician, which I started yesterday, 04/07. No alleviation of symptoms so far.
26 2021-04-07 tingling, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mi... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient felt lighthead and almost passed out. Sweating was profuse but no fever.
26 2021-04-07 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
26 2021-04-08 flushing Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizz... Read more
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Additional Details: Patient experience Syncope
26 2021-04-08 pain in extremity, numbness WHILE PATIENT WAS WAITING 15 MINUTES, HE STARTED LOSING FEELING IN HIS ARMS AND LEGS, NEXT HE LOST A... Read more
WHILE PATIENT WAS WAITING 15 MINUTES, HE STARTED LOSING FEELING IN HIS ARMS AND LEGS, NEXT HE LOST ALL STRENGTH IN ALL EXTREMITIES, STATED PAIN IN ARM AND SIDE OF RIB CAGE, STARTED LOSING VISION TO TUNNEL VISION AND BLURINESS. LIPS APPEARED SWELLING. WRITER CALLED 911 AND GAVE PATIENT EPI SHOT. EMT TOOK TO HOSPITAL
26 2021-04-10 tremor Patient was sitting for his 15 minutes. At about 5 minutes after his vaccine he passed out and fell ... Read more
Patient was sitting for his 15 minutes. At about 5 minutes after his vaccine he passed out and fell off his chair to the floor. The Pharmacy intern noticed that the color of his skin was like a purple and he was passed out. When she started to approach him he started slowly moving his head and adjusting his eyes. He said he felt really dizzy and we had him lay down. He was very sweaty and was shaking a little bit. I took his blood pressure at 11:53 and it was approximately 124/93. He was responsive but feeling dizzy and warm and I stayed with him until the paramedics arrived at about 11:54
26 2021-04-11 tingling Vomiting, lightheadedness, tingling
26 2021-04-12 hot flush Shivers(chills) for a couple hours, low grade fever, after chills hot flashes
26 2021-04-12 muscle spasms, pain in extremity, feeling of body temperature change Soon after receiving the vaccine, heart rate increased, and sweating began. Vision then began to fad... Read more
Soon after receiving the vaccine, heart rate increased, and sweating began. Vision then began to fade to white and ears ringing. This persisted for about 15 minutes, improvement began after 5 minutes. After vaccination, patient was very tired. Sore arm for 5 days. Hot/cold flashes days 3-5. Consitent tiredness 5 days. Muscle aches and cramps days 3-5. After 5 days side effects ceased. Concerns about initial effects
26 2021-04-12 pain in extremity, tenderness Pfizer COVID-19 Vaccine EUA Patient received Pfizer COVID vaccine on 3/12/2021. Patient presented t... Read more
Pfizer COVID-19 Vaccine EUA Patient received Pfizer COVID vaccine on 3/12/2021. Patient presented to outpatient clinic on 4/8/2021 for complaints of leg pain since Monday 4/5/2021. Patient states that Monday he woke up with point tenderness in his left calf which went away after about 2 hours. Tuesday, he woke up the same pain, which is persistent to this point. Patient denies exacerbating or relieving features. Patient denies trauma, no precipitating event and denies history of similar symptoms. Patient has not presented for medical attention for this prior today. Patient had a venous doppler ultrasound which showed a clot in the posterior tibial vein. Patient started on apixaban
26 2021-04-13 bell's palsy Bell?s Palsy
26 2021-04-15 feeling cold feeling very cold; Chills; fever; severe headache; This is a spontaneous report from a contactable c... Read more
feeling very cold; Chills; fever; severe headache; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration in left arm on 09Feb2021 02:45 (at 26-years age) as single dose for COVID-19 immunisation. Medical history included arthritis. Concomitant medication(s) included meloxicam (MELOXICAM) ;amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Previously he received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration in left arm on 19Jan2021 02:45 as single dose for COVID-19 immunisation. He received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021. The patient experienced chills and feeling very cold last night and this morning severe headache and fever on 10Feb2021 12:00. Patient not tested for COVID-19 after the vaccination. No treatment received for reported adverse event. The outcome of the events was not resolved. No follow-up attempts possible. No further information expected.
26 2021-04-15 flushing Syncope, Flushing/sweating, Dizziness; provided hydration + rest
26 2021-04-15 flushing Syncope, Flushing/sweating, dizziness; BP 132/76; HR 90, SpO2 99%
26 2021-04-15 hot flush Nausea, vomiting, hot flashes
26 2021-04-16 cold sweat, feeling hot 5 MINS AFTER RECEIVING VACCINE, FELT HOT, CLAMMY, AND NAUSEA. ASSISTED TO FLOOR TO RAISE FEET BY STA... Read more
5 MINS AFTER RECEIVING VACCINE, FELT HOT, CLAMMY, AND NAUSEA. ASSISTED TO FLOOR TO RAISE FEET BY STAFF. BROUGHT BACK VIA WHEELCHAIR, S/S RESOLVED ONCE ARRIVING. EXCORTED TO EXIT WITHOUT ISSUES AT 1045. 1033 INITIAL BP 128/62 HR 56 RR 18 SATS 98% RA 1041 SITTING BP 133/80 HR 63 RR 18 SATS 98% RA 1043 STANDING BP 124/71 HR 77 RR 18 SATS 97% RA
26 2021-04-16 pain in extremity Fever, fatigue. Moderate to severe arm pain for 9 days.
26 2021-04-17 weakness Fever on set 36 hours post shot; headache; chills; sinus pressure; General soreness across body; Gro... Read more
Fever on set 36 hours post shot; headache; chills; sinus pressure; General soreness across body; Grogginess; This is a spontaneous report received from a contactable consumer (Patient) via Reference No. A 26 year old male reported for himself that he received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: ER8727; expiry date: unknown) via an unspecified route of administration in the left arm on 25-MAR-2021 at 4:00 as a single dose for COVID-19 immnunisation. The patient did not had any relevant medical history. Concomitant medications were not reported. On 27Mar2021, the patient experienced Fever on set 36 hours post shot, headache, chills, sinus pressure, general soreness across body. By 5th day, fever, chills, and soreness have subsided, all that remains is the headaches and grogginess. The patient did not have allergies to medications, food, or other products. The patient did not receive any treatment for the event. The patient did not receive any vaccine prior to vaccination. The outcome for the events headache, chills, para nasal discomfort were captured as recovering and the outcome for pyrexia and grogginess was captured as not recovered. Follow up closed. Information of lot/batch is available.
26 2021-04-17 pain in extremity Sore arm starting 30 minutes after vaccination, lasting 1.5 days. Severe headache starting 45 minut... Read more
Sore arm starting 30 minutes after vaccination, lasting 1.5 days. Severe headache starting 45 minutes after vaccination lasting 1 hour.
26 2021-04-17 unresponsive to stimuli, cold sweat Patient received vaccine at 1440. Patient eyes were opened but claimed to black out and was not resp... Read more
Patient received vaccine at 1440. Patient eyes were opened but claimed to black out and was not responsive to his name. Nurse assessed and patient was clammy and pale. Patient was alert after 1 minute and stated he was dizzy. Medics were called on scene and patients blood pressure was 84/65, heart rate was 45. Medics started an IV with normal saline. Blood pressure 96/64. Patient was transported to hospital.
26 2021-04-18 unresponsive to stimuli, seizure Patient unresponsive; presented with seizure like activity; Patient fall from chair within 15minutes... Read more
Patient unresponsive; presented with seizure like activity; Patient fall from chair within 15minutes of receiving Pfizer vaccine dose 1; pale; diaphoretic; nausea; Full body clonus; This is a spontaneous report from a contactable nurse. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 26 years of age), dose 1 intramuscular, administered in arm left on 03Apr2021 10:45 (Batch/Lot Number: ER8737) as a single dose for COVID-19 immunisation. The patient's medical history included penicillin allergy. The patient's concomitant medications were not reported. The patient had no other vaccine prior to Covid vaccine. He was not diagnosed with COVID-19 prior to vaccination. It was unknown if patient has been tested for COVID-19 since the vaccination. It was reported that the patient fell from chair within 15 minutes of receiving Pfizer vaccine dose 1. Patient was unresponsive, pale, diaphoretic. Awakened within minutes, placed in recovery position on left side. Patient complained of nausea then presented with seizure like activity. Full body clonus. 911 notified. Patient woke within seconds able to state, name, location, date of birth accurately. He was placed on stretcher. EMS arrived. VS 154/80 HR 84, POx99% 2LO2. He continues to be pale. Family of patient notified of event at patient's request. He was transferred to ED via EMS. The events started on 03Apr2021 at 10:45 AM (as reported). Therapeutic measures were taken as a result of the events. The outcome of the events was unknown. Additional information has been requested.; Sender's Comments: Bases on the information in the case report and a strong temporal relationship, A causal relationship between adverse events Unresponsive to stimuli, Seizure and suspect product 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.
26 2021-04-19 feeling cold "Felt tired and a cold developing. Went away around 7pm the same day, 1/27/2021"
26 2021-04-19 flushing "Administered - 14:30, Adverse event started - 14:38. Patient had syncope, flushing/sweating, dizzin... Read more
"Administered - 14:30, Adverse event started - 14:38. Patient had syncope, flushing/sweating, dizziness. History of ""blackouts during blood draws"". BP 92/53 -- > 93/58y, HR 74 -- > 68, RR 18 -- > 18, O2 97% -- > 98%. Patient stable, released from vaccination site."
26 2021-04-19 migraine 3 weeks ago got Pfizer vaccine and has had symptoms ever since. Got pfizer vaccine #1 3/31/21, aroun... Read more
3 weeks ago got Pfizer vaccine and has had symptoms ever since. Got pfizer vaccine #1 3/31/21, around 2pm, at Site. About 90 minutes later started to have migraine HA, then exhaustion, then fever. No ST. Fever has been intermittent since the vaccine until today with spikes every day. Exhaustion and HA have almost been continuous since.
26 2021-04-19 seizure, flushing Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lig... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Seizure-Mild, Additional Details: Patient was found unresponsive on the floor by bystanders with ? siezure like activity, this RN and RN responsed. EMS called to store and was sent to the ER.
26 2021-04-19 unresponsive to stimuli Pt received vaccine and as patient began to schedule second appointment, they experienced a syncopal... Read more
Pt received vaccine and as patient began to schedule second appointment, they experienced a syncopal episode. Pt relaxed back into chair and became unresponsive. Pt was assessed immediately and EMS was called. Heartbeat was palpated and patient was breathing. Within thirty seconds of syncopal episode, pt roused and began to answer questions. Pt was moved to side of the room where they were assisted to a supine position with their legs propped up on a chair. BP 107/80 HR 70 O2 Sat 99%. EMS arrived at 1435. Pt denied feeling dizzy or faint and refused EMS services. Pt remained supine until 1445 at which time pt denied having any symptoms at all and was escorted out of the building.
26 2021-04-20 pain in extremity severe rhabdomyolysis/urinating the color of Coca-Cola and could not walk/CK level of 209,000 U/L; P... Read more
severe rhabdomyolysis/urinating the color of Coca-Cola and could not walk/CK level of 209,000 U/L; Pain in my left arm from vaccine started on Wednesday; Wednesday I worked on upper body and arm/chest/back muscle pains began/On Thursday, I worked on legs and severe quad/glute/hip muscle pain began; This is a spontaneous report from a contactable consumer (Patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:30 (Batch/Lot Number: EN6204) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included reported as none. Concomitant Therapy included multivitamin, joint suppliment. The patient was hospitalized with severe rhabdomyolysis a few days after receiving his first dose of the Pfizer vaccine. He received the vaccine Tuesday 23Mar2021 and went to the gym Wednesday 24Mar2021 and Thursday 25Mar2021. Pain in his left arm from vaccine started on Wednesday and additional muscle pain was induced post workout on both days. Wednesday he worked on upper body and arm/chest/back muscle pains began. On Thursday, he worked on legs and severe quad/glute/hip muscle pain began. Saturday (27Mar2021) he began urinating the color of Coca-Cola and could not walk. Sunday (28Mar2021) he was hospitalized with a creatine phosphokinase (CK) level of 209,000 U/L with no preexisting health conditions that would cause his CK levels to be so extreme. Adverse event severe rhabdomyolysis was started on 27Mar2021 09:00 AM and resulted in Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 7 days. Therapeutic measures were taken as a result of severe rhabdomyolysis included IV fluids. The outcome of the events was recovered.
26 2021-04-21 cold sweat Severe diarrhea (fully liquid) for 2+ days, extreme fatigue, cold sweating, fever.
26 2021-04-21 tenderness, pain in extremity BUMPS HIVES ALL OVER BODY RED ITCHY BRUISED ON INNER THIS AND ARMS SORE AND TENDER
26 2021-04-22 bell's palsy Bell's Palsy. Treatment was steroids (PredniSONE). Unknown time course.
26 2021-04-22 cold sweat Pt reported feeling a cold sweat followed by dizziness, clinical staff assisted him giving water and... Read more
Pt reported feeling a cold sweat followed by dizziness, clinical staff assisted him giving water and snack,Pt continued to feel dizzy and was assisted to the floor into recovery position until picked up by medical observartion staff. PT was transported by stretcher and monitored . Pt claims to begin feeling better and was released on his on charge at 09:50 am. Vitals as follows: 09:31 BP 109/73 HR 63 RR 20 Sp02 !00% Lying 09:38 BP 113/73 HR 62 RR 18 Spo2 100% sitting 09:46 BP 107/71 HR 58 RR 18 Sp02 100% standing
26 2021-04-23 coordination abnormal, tingling, numbness About two or three days after my second Pfizer vaccination I started to feel some immense pain in my... Read more
About two or three days after my second Pfizer vaccination I started to feel some immense pain in my right trapezius. I had difficulty moving my neck for several hours. The pain subsided later that day but I still had adverse effects. I had a numbing and tingling feeling that traveled from my right trapezius all the way down to my fingers. That sensation continued for several weeks (3 or so) until I saw my general physician. She conducted some strength tests and noticed that there was some weakness and lack of coordination on my right side. I was instructed to go get and MRI and the results showed 5 lesions in my brain and 1 in my cervical spine (C2-C3). After many other tests including blood tests and a follow up MRI the neurologist that viewed my case informed me that I showed a strong case of demylination and it looked likely that Multiple Sclerosis. The shot might have caused an immune response which allowed the MS to appear.
26 2021-04-26 weakness Situation: patient was administered 1st dose of COVID-19 (Pfizer) by certified tech. Post-administra... Read more
Situation: patient was administered 1st dose of COVID-19 (Pfizer) by certified tech. Post-administration, patient was instructed to sit for observation. Technician stated that approximately 2 min or so after patient sat down, he came up to her at the window to state that he was feeling lightheaded and weak. Consequently, while in conversation with her, patient gently collapsed onto the floor. He was alert and conscious the entire time; temp was 97; patient was noted to be pale and sweating profusely. Patient was provided water, ice pack and orange juice. Ambulance was offered and he was taken by paramedic for further evaluation.
26 2021-04-27 numbness A few days after my vaccine i was sitting in a chair and touched my calf and noticed that it was num... Read more
A few days after my vaccine i was sitting in a chair and touched my calf and noticed that it was numb. It wasnt pins and needles as if it had fallen asleep. It just had significantly decreased sensitivity. I stood up and walked around to try to fix this but the symptoms persisted for at least 36 hours before subsiding to a much lesser but still present degree of numbness. I went to my doctor and they told me that it was not an emergency aince there was no pain and it caused no weakness. This is localized to the skin on my outer left calf. He said this can be caused by crossing your legs too much but i dont ever do that. 3 weeks later and i still have muted sensations in my left calf. It mostly goes unnoticed until i go to scrub my leg in the shower or something and notice that the scrubber feels significantly different on each leg. The left side feels like "static".
26 2021-04-27 migraine Fever, migraine, fatigue
26 2021-04-27 seizure, unresponsive to stimuli Pt had generalized seizure, pupils dilated, non reactive, upper extremities contracted, diaphoretic,... Read more
Pt had generalized seizure, pupils dilated, non reactive, upper extremities contracted, diaphoretic, apneic. Seizure activity lasted approximately 30 sec. Pt attended by Rn clinic supervisor and NP.
26 2021-04-29 seizure Patient immediately felt dizzy after injection. He then passed out in his chair and we put him down ... Read more
Patient immediately felt dizzy after injection. He then passed out in his chair and we put him down on the floor. He then had a seizure lasting a couple seconds. The entire episode lasted less than a minute and he then regained consciousness and was responsive. Emergency services was contacted at the first sign of the seizure and upon arrival, they checked that he was alert and oriented x4. Patient did not go to the hospital but he did go home with a family member.
26 2021-04-29 tremor Body temperature : 100.8 Body shaking
26 2021-04-30 seizure Seizure; crashed my car.; don't remember 45 minutes of my life; This is a spontaneous report from a ... Read more
Seizure; crashed my car.; don't remember 45 minutes of my life; This is a spontaneous report from a Contactable Consumer (patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Apr2021 13:15 (Batch/Lot Number: ER8735) as SINGLE DOSE for covid-19 immunisation at a vaccine facility, at 26 years old. Medical history included known allergies: Penicillin from an unknown date. No other vaccine in four weeks. Patient did not COVID prior vaccination and has not been tested for COVID post vaccination. Concomitant medication included bupropion; and venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported. Patient waited 15 minutes and felt normal. Patient stopped for gas and soda and then patient stated to be honest he woke up surprised with EMT, police and fire just telling him he started having a seizure and crashed his car on 17Apr2021 13:30. Patient stated "that's craziest laser I don't remember 45 minutes of my life (onset 17Apr2021). Thought I would be like 140. It was 3 pm which leave a large gap. This is really scary for me and my family". The events resulted in emergency room visit for seizure and crashed his car. The patient was hospitalized for seizure and for crashed his car for 1 day. Therapeutic measures were taken as a result of seizure and crashed my car (Some things to regulate my heart rhythm). Outcome of the events seizure and crashed his car was not recovered while unknown for don't remember 45 minutes of his life.
26 2021-05-01 cold sweat 103 degree fever, cold sweats, body aches, headache
26 2021-05-01 unresponsive to stimuli, numbness Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Numb... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: numbness in arms
26 2021-05-03 weakness Pfizer-BioNTech COVID-19 Vaccine The patient received the vaccine in his left arm, and 5 minutes lat... Read more
Pfizer-BioNTech COVID-19 Vaccine The patient received the vaccine in his left arm, and 5 minutes later lost consciousness/passed out for several minutes then woke up feeling weak and tired
26 2021-05-04 feeling hot, pain in extremity 1st Pfizer shot beginning of April went fine. Only a sore arm. 2nd shot this past Saturday was a dif... Read more
1st Pfizer shot beginning of April went fine. Only a sore arm. 2nd shot this past Saturday was a different story. I got the shot around 3:30 and felt great until about 7. My arm started getting very sore. It got better a little later in the day. Next morning I felt pretty fatigued but nothing I haven?t felt before. Sore arm was still there. Pretty manageable. Had to pick up groceries and that was a mistake. Had to take deep breaths and my knees were in a lot of pain as I got out of the car and walked through the store (I injured them years ago and now have Baker's cysts). Wife brought me home and I had rigors on the ride back. I got home around 11:45 or so and I put on a blanket. I felt so hot I started to get a little bit delusional and very sad/started getting teary. Took off blanket and couldn?t get off the couch or walk without help. Knees now felt like about to fall apart. Wife takes temp shows 107, makes ice bath, I get in and it goes down to 105 a few minutes later. Temp went down to 103 over the next 15-20 minutes and stayed there. Got out with her help and still couldn?t stand up or walk without help. Sat upright in bed rest of the day. Fever ranged from 98-103, mostly 101-103. Took a very cold shower later in the day but temp still stayed in the same range. All other symptoms mentions else stayed the same. I also now had no appetite and felt nauseous. Stomach felt rock hard, and I didn?t feel too with it. Finally fell asleep later at night and woke up feeling way better but still awful. Monday and Tuesday I had to take off work I felt so fatigued. Both of those days I had no fever, it went away from Sunday night into Monday. I can walk by myself now and just feel a little fatigued today. I have my appetite back now and am back to work. I should mention that I took Tylenol which didn?t help. Ibuprofen I took later in the day and that might have helped a little. Took Benadryl later and that helped with sleep.
26 2021-05-06 feeling hot Patient was sitting in chair after vaccine waiting the required 15 minutes. He states he was staring... Read more
Patient was sitting in chair after vaccine waiting the required 15 minutes. He states he was staring sown watching his phone and he felt hot and then woke up on the floor with people around him. He fainted. He felt hot and sweaty afterward. Episode seemed to pass within about 10 minutes all together. Paramedics came and checked him out since he hit his head when he fell. Patient didn't want to go to hospital and was picked up from the store by family member.
26 2021-05-07 pain in extremity Runny nose for the first hour after. Sore arm for at least two days.
26 2021-05-07 seizure seizure; Body soreness; Inability to sleep/stay asleep; Loss of memory/confusion; Loss of memory/con... Read more
seizure; Body soreness; Inability to sleep/stay asleep; Loss of memory/confusion; Loss of memory/confusion; This is a spontaneous report from a contactable consumer. A 26-yearsold male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 29Apr2021 13:00 (Lot Number: EW0161) via an unspecified route of administration, administered in Arm Right as single dose for covid-19 immunization (Age at vaccination: 26 years). Medical history included High blood pressure. Concomitant medication included marijuana. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm (lot number: EW0150) on 08Apr2021, 10:00AM for covid-19 immunization (Age at vaccination: 25 years). The patient experienced seizure, body soreness, inability to sleep/stay asleep (initial insomnia), loss of memory/confusion on 30Apr2021 07:00. The events were assessed as life-threatening by the reporter. The patient was not diagnosed with COVID-19 prior vaccination and the patient has not been tested with COVID-19 since the vaccination. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
26 2021-05-09 seizure, feeling hot Pt reports that he waited for about 20 minutes after being vaccinated. During that time he felt a li... Read more
Pt reports that he waited for about 20 minutes after being vaccinated. During that time he felt a little hot and drank some water, but says he otherwise felt fine. He states that he stopped for gas after leaving the clinic and has no memories after that until he was being pulled from his car by a paramedic. He states that he was told he had a seizure and crashed his car. After the motor vehicle accident he says he was transported to the hospital, where they told him he had had a seizure, did some tests, and then released him. Pt states his heart rate and glucose were both elevated when he was at the hospital, but that his CT scan was normal. He states he was feeling fine we he got gas, and says he feels fine now (5/10/21: three weeks and two days later). He saw his primary care provider last week (5/5/21) and was referred to Neurology. He had an MRI done, which he reports was normal, and an EEG, which he says he is still waiting on results from. Pt reports no history of seizure prior to 4/17/21.
26 2021-05-10 pain in extremity Felt a little sick the day after. Significant arm pain for 2 days after. Starting 5 days after lymph... Read more
Felt a little sick the day after. Significant arm pain for 2 days after. Starting 5 days after lymph node under armpit swelled to the size of a nickel (by 4/24/21) and was very painful. Returned to normal around 4/27. At about that same time lymph nodes under jaw began to swell and were painful by 5/1. This seemed to return to normal by 5/6. Since then no other adverse affects.
26 2021-05-10 pain in extremity A male patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injectio... Read more
A male patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0161 and expiration date was not reported) via an unspecified route of administration, administered in Arm Left (Left Shoulder Side of the Arm s single dose for covid-19 immunisation. Vaccination facility type was other. Reportedly, patient had no history, no other products and no investigational assessment. Patient did not have any family medical relevant history. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 evening the patient experienced left arm sore, on 17Apr2021 patient experienced fever, head pounding, Lower Half of Body was Very Sore; Muscle Aches (muscle pain). The patient states he was calling about his first dose, he got the first dose on this past Friday, 16Apr2021 and he was fine that day and then the following day, Saturday night, he had a fever and he still has a fever 4 days later. Is it normal to have a fever after 5 days. The report was not related to a study or a program. Patient took treatment Montrin. Patient did not went to emergency room or physician office, he went to urgent care. The outcome of the event pyrexia is not recovered, left arm pain recovered on 18Apr2021, muscle pain (Lower Half of Body was Very Sore; Muscle Aches) recovered on 17Apr2021 and head pounding recovered on 18Apr2021. No follow-up attempts are needed. No further information is expected.
26 2021-05-10 pain in extremity his arm is sore and tight; his arm is sore and tight; specifically soreness where the shot was.; Thi... Read more
his arm is sore and tight; his arm is sore and tight; specifically soreness where the shot was.; This is a spontaneous report from a contactable consumer reported for himself. This 26-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the Pfizer covid 19 vaccine on 20Apr2021 and his arm was sore and tight, specifically soreness where the shot was. Event outcome was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
26 2021-05-11 pain in extremity Pain in the left arm, headache, and fever (100 F), relieved in about 24 hours
26 2021-05-11 tingling Gradual stiffness and tightening of both shoulder joints. Reduced flexibility in knees the first nig... Read more
Gradual stiffness and tightening of both shoulder joints. Reduced flexibility in knees the first night and pain during normal range of motion. 5-minute intervals of paresthesia in both hands and wrists every couple of hours. Nausea the next day.
26 2021-05-12 tingling I am experiencing brain-fog like symptoms. My sensations are dulled, I cannot process what's going a... Read more
I am experiencing brain-fog like symptoms. My sensations are dulled, I cannot process what's going around me the way I used to be able to. For example, I am having trouble holding conversations that require a lot of thinking. I am quick to lose focus, and it is difficult to engage in cognitive activities because of it. It feels like I am "up in the clouds" as if I am experiencing a drunk-like feeling or marijuana high. It is as if I am able to feel all the sensations, but somewhere in the brain, there is a disconnect happening that I am not able to be as sensitive as I used to be. I am dull to the usual pain sensations I would normally feel (e.g. when I scratch a part of my body, or when I am in an uncomfortable position for a longer time). Just overall, my sensations are not as sensitive so everything seems duller. I do not feel like I'm 100% there in my body. I have not had any adverse side effects to other vaccines I have received in the past. I may have gotten the usual flu-like symptoms but nothing as bizarre as the symptoms I am experiencing currently.
26 2021-05-13 migraine 2 days of migraine, joint and muscle pain throughout body, low-grade fever, fatigue/drowsiness
26 2021-05-14 seizure, tremor Started violently shaking uncontrollably for 30 minutes. Nothing I did helped or stopped it, I kept ... Read more
Started violently shaking uncontrollably for 30 minutes. Nothing I did helped or stopped it, I kept biting my tongue and could not walk, my entire body was shaking very very aggressively, I stayed laid down and focused on relaxing my body, eventually it calmed down on its own and I quickly tried to fall asleep before it came back, I feel fine today, just really shaken up and frightened. I did not call anyone and have not seen any doctor about it. I thought I was having a seizure, except was conscious.
26 2021-05-15 migraine Flu like symptoms; nausea, migraines, muscle aches, chills, fever. Treated with NyQuil and Ibuprofen
26 2021-05-16 cold sweat Became pale and clammy. Felt "light-headed." He asked for water. Lied down on mat, feet elevated. Fe... Read more
Became pale and clammy. Felt "light-headed." He asked for water. Lied down on mat, feet elevated. Feeling of light-headedness passed after 5 minutes (1848). Right deltoid site benign. Monitoring changed to 30 minutes. Sat up at 1852. Color better, no longer clammy. Given water and juice. Tolerated well. Feeling better @1858. Will wait 30 minutes at next vaccination, educated & states understanding.
26 2021-05-17 discomfort I have suffered from mild tinnitus from exposure to loud sounds, mostly pronounced in my left ear, f... Read more
I have suffered from mild tinnitus from exposure to loud sounds, mostly pronounced in my left ear, for several years now. About 1 week after my second dose I noticed that my tinnitus (the ringing in my ears) got significantly worse - especially in my left ear. My perception of dynamic range for sounds was severely limited and loud sounds sounded like static and caused headaches and significant discomfort. It is now 5/18, my second dose was 4/29 and my tinnitus is still significantly worse than before I got my shot.
26 2021-05-17 pain in extremity -sore arm 2 hours after appt (4:30pm, 5/17) -extreme chills and shivering (2:00am, 5/18) -high fever... Read more
-sore arm 2 hours after appt (4:30pm, 5/17) -extreme chills and shivering (2:00am, 5/18) -high fever (speculated 104-105, 2:00am, 5/18) -delirium (2:00 am, 5/18) -continued fever (101, 10:10 am 5/18)
26 2021-05-18 weakness Woke up feeling weak and tired; Woke up feeling weak and tired; Lost consciousness/passed out for se... Read more
Woke up feeling weak and tired; Woke up feeling weak and tired; Lost consciousness/passed out for several minutes; This is a spontaneous report from a non-contactable consumer (patient). A 26 years-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0173) in the left arm, at single dose, on 04May2021, at 08:45 AM, for COVID-19 immunisation. COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, was not the patient diagnosed with COVID-19. Relevant medical history and concomitant medications were unknown. It was reported that the patient received the first dose of vaccine in left arm, then 5 minutes later, on 04May2021, lost consciousness/passed out for several minutes. Woke up feeling weak and tired on an unspecified date. Emergency Room Visit /department or urgent care required. Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the events was unknown at time of this report. No follow-up attempts possible. No further information expected.
26 2021-05-18 tremor administered first dose of Pfizer to patient. Patient was waiting 15 minutes post vaccine and when w... Read more
administered first dose of Pfizer to patient. Patient was waiting 15 minutes post vaccine and when we went to check on him before closing for lunch, patient reported SOB and difficulty breathing. He stated he was currently a Nurse and requested administration of Epipen. administered 1 dose of EpiPen. Patient requested a second dose of Epipen but did not appear to need another dose and reported tightness lifted off chest but still SOB noted. called 911. administered patient 25 mg Benadryl liquid dose as secondary measure per protocol. Patient consumed 2 bottles of water prior to Ambulance arriving about 25 minutes after calling 911. Patient refused to lie down in supine position. He reported to EMTs that he had allergy to NSAIDs and Zoloft, so updated patient's PQCF form to reflect since patient originally reported NO to DRUG ALLERGIES. Patient left with EMTs on stretcher but reported SOB improving but still present.
26 2021-05-18 unresponsive to stimuli The patient was unresponsive, pale, and diaphoretic when I arrived at their vehicle. The patient rap... Read more
The patient was unresponsive, pale, and diaphoretic when I arrived at their vehicle. The patient rapidly regained consciousness and was alert. The patient was repositioned with legs elevated. Hydration was given. There was one episode of emesis, which resolved the patient's nausea. This was a vasovagal episode with true syncope. The patient improved rapidly with supportive care, increased monitoring, and hydration. He was returned home with his father as the driver.
26 2021-05-19 cold sweat Syncopal Episode Vital Signs: BP 92/64 HR 60 Resp 14 O2Sat 98% Skin Signs: Clammy, diaphoretic Ci... Read more
Syncopal Episode Vital Signs: BP 92/64 HR 60 Resp 14 O2Sat 98% Skin Signs: Clammy, diaphoretic Circulation: Cap refill 4-5 sec Respiratory: Breath sound clear bilaterally Initial Treatment: Patient received vaccine, fell to syncope - responsive after 5 seconds. Patient hit concrete floor with a loud sound. Patient awake after 5 seconds. A/Ox5 Patient moved to L lateral position with manual spinal check. 11:50 AM Vital Signs: BP 99/60 HR 78 Resp 18 O2Sat 97% Skin Signs: Diaphoretic Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: EMS on scene. Patient assessed by EMS. Spine cleared by EMS. Patient moved to superior posterior. Patient refused further transport to hospital. 12:00 PM Patient discharged home, escorted by EMS and significant other.
26 2021-05-19 migraine Developed chest pain, migraine and dizziness within 5 minutes of vaccination.
26 2021-05-20 bell's palsy Developed Bell?s Palsy on left side of face
26 2021-05-23 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild
26 2021-05-24 pain in extremity Chills and fever started at 2:00 am almost after 11 hrs of taking the vaccine. Chills subsided afte... Read more
Chills and fever started at 2:00 am almost after 11 hrs of taking the vaccine. Chills subsided after 20-30 minutes and fever was around 100.2 F. Heart Rate slightly elevated at night but in normal rane i.e below 100 BPM. Right arm soreness constant. Extreme headache and leg pain in the morning around 9:30 am.
26 2021-05-25 weakness A 26-year-old male with no past medical history presents to the emergency department (ED) with an ac... Read more
A 26-year-old male with no past medical history presents to the emergency department (ED) with an acute episode of chest pain. He reports initially mild dull substernal chest pain for a day prior to an episode of acute sharp chest pain that radiates to his left neck and left shoulder accompanied by diaphoresis leading him to present to the ED. He had received the second dose of the Pfizer-BioNTech mRNA COVID-19 vaccine three days prior to presentation and reported myalgia and weakness beginning within 24 hours of vaccination. His blood pressure on arrival was 126/83 mmHg and pulse was 61 bpm. Electrocardiogram (ECG) on admission showed diffuse upsloping 2mm STE, no reciprocal changes, and PR elevation in aVR. Troponin-I on admission was 6.03 ng/ml prior to peaking at 21 ng/ml while initial CRP was 56.8 mg/L. Transthoracic echo (TTE) showed left ventricular ejection fraction (LVEF) of 55-60% with hypokinesis of the basal lateral wall. Cardiac magnetic resonance imaging (CMR) was consistent with myocarditis showing subepicardial late gadolinium enhancement (LGE) in the basal inferior wall, no edema on T2 sequences, and a mildly reduced left ventricular systolic function with an LVEF of 51%. He was started on colchicine, low dose beta blocker and losartan and improved symptomatically along with resolution of the EKG findings prior to being discharged with plan for close outpatient follow-up and repeat imaging. In addition, a respiratory viral PCR panel was obtained which was positive for Rhinovirus/Enterovirus on nasal swab. Although it is possible that his presentation was secondary to enteroviral myocarditis, the temporal relationship to the second dose of Pfizer-BioNTech mRNA COVID-19 vaccine suggests the possibility of myocarditis secondary to immunologic response to COVID-19 vaccine itself.
26 2021-05-25 seizure Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Severe, Systemic: Seizure-Severe
26 2021-05-26 seizure like phenomena 9:05am pt had just received 1st dose Pfizer vaccine and lost consciousness at the table with seizure... Read more
9:05am pt had just received 1st dose Pfizer vaccine and lost consciousness at the table with seizure like activity. Pt was lowered to floor with assistance of several staff members. Pt very diaphoretic with decrease in skin color. Didn't hit head. Pt mother called per pt request and states him having no hx of seizures and NKA. BP 94/60 and HR 84. 9:20 am pt assisted to stretcher with heavy assist. 9:24am A&O when EMS unit arrived to transport pt to hospital for further evaluation and care.
26 2021-05-29 pain in extremity About 12-24 hours After receiving the vaccine I experienced the common side effects, sore arm, tired... Read more
About 12-24 hours After receiving the vaccine I experienced the common side effects, sore arm, tiredness, headache, nausea and lightheaded. However, I have been noticing that ever since I completed the 2 dose series I have been feeling dizzy randomly. First I thought it was normal but now is been months and I constantly feel dizzy. I check my blood pressure and heart rate thinking it may be due to that but they?re usually within normal ranges and the dizziness episodes just come and go throughout the day.
26 2021-05-30 tingling, migraine Had symptoms of tightness in chest high fever chills rapid heartbeat fluttering of heart nausea vomi... Read more
Had symptoms of tightness in chest high fever chills rapid heartbeat fluttering of heart nausea vomiting difficulty breathing lightheaded and tingling of fingers and lips severe migraine
26 2021-05-31 pain in extremity Patient received first injection left deltoid in April; 2 weeks later swelling and pain with reduced... Read more
Patient received first injection left deltoid in April; 2 weeks later swelling and pain with reduced range of motion to the left shoulder. Received second injection right deltoid in May; 2 weeks later swelling and pain with reduced range of motion to the right shoulder and worsening persistent symptoms to left shoulder. Symptoms are persistent. Not related to Sickle Cell Crisis; has been seen by specialists.
26 2021-05-31 tingling Patient had acute onset post-vaccination at 10 mins of nausea, bilateral UE and LE tingling sensatio... Read more
Patient had acute onset post-vaccination at 10 mins of nausea, bilateral UE and LE tingling sensation, no dermatological changes. Denied SOB. Patient reported last food was 30 mins prior to vaccination with bagel. Patient vitals as stated below and given OJ and gummies. VITALS: T97.7, HR 75, RR 14, O2 95%, BP 150/82 After 10 mins of snacks, symptoms were improving. After 15 mins, symptoms resolved entirely. patient left site 30 mins after onset without reoccurrence.
26 2021-06-01 night sweats Chest pain, chest tightness, difficulty breathing, all of which were worse when lying down. Soon dev... Read more
Chest pain, chest tightness, difficulty breathing, all of which were worse when lying down. Soon developed fever, chills, and night sweats, and eventually tachycardia (resting 160 bpm) with atrial flutter and then atrial fibrillation Original pain was within the week of the vaccine, but the fever came on about a month later and lasted for 2 weeks.
26 2021-06-06 pain in extremity Fever, body ache, pain in the left arm
26 2021-06-07 tingling patient reports having tingling/chills about 90 min after vaccination. No rash/hives/swelling or dif... Read more
patient reports having tingling/chills about 90 min after vaccination. No rash/hives/swelling or difficulty breathing. Some lightheadedness and feeling of blacking out. Patient did not have this reaction with the first pfizer shot. Patient was concerned since the onset was so soon after vaccination. Recommended patient rest as much as possible, drink plenty of water and eat some food. Patient may take tylenol if needed for fever/pain. Patient did have a granola bar and water for breakfast and had just recently ate lunch. Recommended no driving or any activity that requires attention/moving due to lightheadedness. Patient does have someone that will be checking in on him to see how he is doing. Advised that patient seek medical attention if condition worsens or if any trouble breathing or swelling
26 2021-06-08 muscle spasms A few hours after getting the 2nd dose, I had the following reactions (I didn't go to the doctor, I'... Read more
A few hours after getting the 2nd dose, I had the following reactions (I didn't go to the doctor, I'm just reporting what I experienced): *Slight rash consisting of pen-dot sized raised blisters which only appeared on top of a long-healed tattoo I have *Pain all throughout my right jugular (neck) *Sharp pain behind my right ear *Sleepiness *Dizziness *Muscle aches and muscle cramps Most of these lasted less than 24 hours, but the tattoo rash was progressively becoming worse, I managed to get it under control on day 4 by applying hydrocortisone directly over the immidiate area. I still see a few bumps, but it seems to be healing. I didn't do anything differently in my daily routine; nothing changed (ie: same soap, same detergent, no contact with dust or etcetera). The tattoo also contains phosphorus, which might be related to the reaction. The muscle aches and cramps are still ongoing; which is weird considering how I never get either and my daily activities haven't changed.
26 2021-06-08 pain in extremity, burning sensation Was afflicted with Severe poison Ivy on back of left leg from below glute down to mid calf. I had nu... Read more
Was afflicted with Severe poison Ivy on back of left leg from below glute down to mid calf. I had numerous smaller and less severe patches. Before getting the covid shot, I had had poision ivy for about 10 days. On the second day after receiving second shot of pfizer, I had a secondary rash occur that surrounded the poison ivy rash. There was a noticeable difference in that the covid rash appeared to come from within the body rather than the poison ivy rash that looked and felt as a more external rash. The symptoms aside from additional rash was when I would move around and generated any type of body heat the "covid rash" would begin to severely itch and irritate. Additionally, If I would go for walks, the area on my leg that still had the poison ivy rash along with the covid rash would not only itch but burn. It created the sensation that a lighter was being held to my skin. It was quite painful. The other small areas that had the mix of poison ivy and covid rash were not as painful when I was moving around/ walking like the bigger afflicted area.
26 2021-06-10 muscle twitching extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting i... Read more
extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting in fainting and twitching while unconscious; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 25May2021 at 11:00 as an unknown dose number, at a single dose for COVID-19 immunization. The patient's 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 has not been tested for COVID-19. The patient experienced extreme headache resulting in fainting and twitching while unconscious on 25May2021 at 20:00. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
26 2021-06-11 numbness Severe headache numb hands and high temperature 100.5
26 2021-06-13 seizure like phenomena After patient received his 1st dose COVID vaccine, patient came to the door where nurse was statione... Read more
After patient received his 1st dose COVID vaccine, patient came to the door where nurse was stationed. Patient stated he felt like he was having a seizure and his head was hurting. Nurse notified (pharmacist) and a medical alert was called. Nurse assisted him to the chair. Patient said he felt like his eyes were heavy and head was hurting. Patient was assisted to lay on the bench. We called 911 for fire rescue, at that moment ER nurse arrived with a wheelchair. patient was transported to wheelchair and sent to the ER with another person and accompanied by ANM, security and patient's father.
26 2021-06-13 tremor, flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mil... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: patient received first dose of pfizer vaccine with in 2 minutes passed out parents then told me later he has Aspergers and is very much afraid of needles has had reactions before after getting shots but none quite this severe patient was sitting and when he passed out he did not hit his head mother was beside him and helped him down called ems patient did not want to be transported to hospital left rx 20 minutes later
26 2021-06-13 unresponsive to stimuli, tremor, flushing Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
26 2021-06-16 discomfort Left ring finger pressure sensation, immediately after injection & lasting >15 minutes after injecti... Read more
Left ring finger pressure sensation, immediately after injection & lasting >15 minutes after injection. Patient attempted to stretch the area move fingers. No improvement. Routed to Urgent Care for follow up. No new or worsening sx during monitoring.
26 2021-06-16 flushing This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient re... Read more
This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received 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 13:00 as a single dose for COVID-19 immunisation. The patient had no allergies to medications, food or other products. No medical history was reported. Concomitant medication included Emtricitabine ,Tenofovir Alafenamide (DESCOVY), Vitamin D, amphetamine salts (within two weeks of vaccination) for an unknown indication. The patient 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. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 17:00, patient had flushed face which was more severe on left side (same side as vaccine shot). The clinical outcome of flushed face was not recovered. No follow-up attempts are needed. No further information is expected.
26 2021-06-16 migraine Migraines; brain fog; Panic attacks; Psychosis; This is a spontaneous report from a contactable cons... Read more
Migraines; brain fog; Panic attacks; Psychosis; This is a spontaneous report from a contactable consumer, the patient. This 26-year-old male patient reported that he received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0182 59267-1000-01) via an unspecified route in the right arm on 05May2021 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to apples. Concomitant medications were not reported. 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. On 06May2021, the patient experienced migraines, brain fog, panic attacks, and psychosis; all serious for hospitalization. Patient was hospitalized for 5 days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The clinical outcome of the events migraines, brain fog, panic attacks, and psychosis was not recovered. Since the vaccination, patient has been tested for COVID-19, result was unknown.
26 2021-06-20 feeling hot, tingling Cold sores, hives, bumps, rashes, severe itching over arms, legs, chest, and back of neck. Numbness ... Read more
Cold sores, hives, bumps, rashes, severe itching over arms, legs, chest, and back of neck. Numbness and tingling in cranial nerves. Back of neck hot, pins and needles. Severe head fog, fatigue.
26 2021-06-20 tremor Approximately 5 minutes after vaccination patient started slumping in chair. He was helped to the f... Read more
Approximately 5 minutes after vaccination patient started slumping in chair. He was helped to the floor by his companion. He had blurred vision and mild shaking and kept asking what is going on. He was asked to lay down on the floor but chose to remain sitting on the floor. He was given a cold compress for his neck and stayed seated on the floor until he felt better. He stated that he was not dizzy, lightheaded but felt really tired. He recovered and stayed for about 15 minutes after recovering. He declined any medical attention and had a ride with his companion. He was advised to seek medical attention at the ER.
26 2021-06-23 tingling PATIENT COMPLAINED OF FEELING FAINT, TINGLING TO FINGERS AND RADIAL SIDE OF HAND. HE WAS DIAPHORETI... Read more
PATIENT COMPLAINED OF FEELING FAINT, TINGLING TO FINGERS AND RADIAL SIDE OF HAND. HE WAS DIAPHORETIC. PATIENT DRANK WATER. PATIENT LAYED DOWN ON COT AND WAS OBSERVED.
26 2021-06-24 slurring Severe brain fog; difficulty concentrating, slow reaction speeds, struggling with articulation/ word... Read more
Severe brain fog; difficulty concentrating, slow reaction speeds, struggling with articulation/ word-finding, memory issues, general confusion and struggling to take in information. Inability to sleep despite fatigue. It feels like my IQ dropped 10-15 points.
26 2021-06-24 numbness, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Pt fainted a minute after recieving his vaccine. Was unresponsive for a few seconds and got up after. Bite his tongue from the fall head first. Paramedics were called and he was quickly evaluated with no vitals out of range. He went home and napped and after follow up call, feels better now 7 hours later. He confirmed had light headache,was tired so napped and also had tingling in his arm and also confirmed he did not drink water or eat anything before his visit. Now he feels fine.
26 2021-06-27 discomfort Dealing with moderate carpal tunnel symptoms, worse on non shot arm (right) mild symptoms in left ar... Read more
Dealing with moderate carpal tunnel symptoms, worse on non shot arm (right) mild symptoms in left arm. Shooting pains throughout left and right arm and hand as a result. Pressure and stiffness in right arm almost always.
26 2021-06-28 muscle twitching Muscle twitching in different muscles. Started at the left arm
26 2021-07-01 seizure The patient was given the Pfizer COVID vaccine. The patient immediately felt nausea and dizzy. The p... Read more
The patient was given the Pfizer COVID vaccine. The patient immediately felt nausea and dizzy. The patient's wife asked up to call for help and we called 9-1-1. The patient then fainted and had some seizure like activity. The patient woke up immediately after. The patient had no previous history of fainting or seizures but has almost fainted after blood tests. The EMT's came and checked his vitals which were all normal. Then the patient was taken to the hospital.
26 2021-07-02 cold sweat PATIENT STATED WHILE WAITING IN PHRMACY WAITING SEATED IN ROOM HE WAS FEELING SWEATY /CLAMMY , LI... Read more
PATIENT STATED WHILE WAITING IN PHRMACY WAITING SEATED IN ROOM HE WAS FEELING SWEATY /CLAMMY , LIGHT HEADED ABOUT 10 MINUTES AFTER 2ND DOSE OF PFIZER COVID 19 VACCINATION GIVIN AT APPROX 3PM .PATIENT THEN SAID HE STOOD UP TO GET ATTENTION FROM PHARMACY PERSONNELL AND FEINTED . BOTH PHARMACIST AND CLERK SAW PATIENT PASSING OUT AND LOWERED PATIENT TO THE FLOOR. A FEW MINUTES LATER PATIENT REGAINED CONCIOUSNESS. PARAMEDICS WERE CALLED AND WAS TAKEN TO HOSPITAL FOR CHECK UP
26 2021-07-09 unresponsive to stimuli, unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: pt fainted approximately 30 seconds af... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: pt fainted approximately 30 seconds after receiving vaccination. Patient was seated but hit is neck on the arm of the chair. He also hit his head on the wall located next to the chair where patient was seated. Blood pressure was taken- 116/68 pulse 78
26 2021-07-10 pain in extremity Pain in right arm; mild itching all over; neck pain opposite of injection site; joint pain; This is ... Read more
Pain in right arm; mild itching all over; neck pain opposite of injection site; joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7533) via unspecified route of administration in the right arm on 27Mar2021 at 17:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included overweight. Concomitant medications were not reported. It was unknown if the patient had any known 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 tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021 at 10:00, the patient experienced pain in right arm, mild itching all over, neck pain opposite of injection site and mild joint pain. 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 pain in extremity, pruritus, neck pain and arthralgia were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
26 2021-07-11 tingling Shortly after receiving the covid vaccine first shot. I began to develop symptoms that I have never ... Read more
Shortly after receiving the covid vaccine first shot. I began to develop symptoms that I have never previously felt and have sent me to the hospital in the time since. I have developed serious pins and needles sensation in my left foot, and hands. My left foot and leg constantly feel stiff. My left foot constantly feels as though it is buzzing or vibrating. I have received 3 blood test, imaging test, spent thousands of dollars trying to figure out what is wrong with me. The only thing in my life that changed was the covid vaccine. I can no longer work out due to pain in my leg. I am extremly heat intolerant. This vaccine has ruined my life.
26 2021-07-12 feeling of body temperature change, muscle spasms Immediate stomach ache, pt threw up, nausea, tachycardia, leg spasm, hot/cold, dizzy.
26 2021-07-12 unresponsive to stimuli, tremor, seizure Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Mild, Additio... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Mild, Additional Details: shortly after receiving vaccination, the patient became unconscious, fell out of his chair and to the floor, and began to seize. Body shaking lasted around 15-20 seconds. Patient then immediately became alert and concscious. Stated after this episode that he has a history of fainting and having seizures after he receives vaccinations. Patient vomited ~15-20 minutes after this episode.
26 2021-07-13 pain in extremity Erectile Dysfunction; Fatigue; Extreme Arm pain
26 2021-07-24 facial pain, migraine Initially after injection was fine. On 3/27 afternoon, experienced sinus fullness and throbbing head... Read more
Initially after injection was fine. On 3/27 afternoon, experienced sinus fullness and throbbing headache Extreme light sensitivity Felt like head was going to explode, hard to sleep. (saturday, 3/27) Went to urgent care the next day, care provider said it was a sinus migraine and prescribed antibiotics. (sunday, 3/28) Symptoms did not get better and continued to persist, headache became even worse / unable to work. (monday, 3/29 to 3/30) Stopped taking antibiotics 3/31 Went to see PCP on 4/2, was prescribed sumatriptan. Didn't seem to help. Found out a week later that covering one eye would help with the headache. Went to optometrist 4/8, confirmed that there was strabismus (left eye pointing down, right eye pointing up, prescription adjusted. Initial relief, but headaches returned a week later even with updated prescription (with prism) Had a follow-up with PCP 4/26 and got referral to a head and neck specialist. CT scan of sinus performed on 4/27, nothing weird spotted. Was prescribed verapramil. Made me extremely dizzy and did not help - stopped taking after a week. Continued to work with HNT, confirmed nothing wrong (physically) with brain after MRI. Saw specialist for strabismus - the misalignment at that point was no longer present. Continued to have on and off headaches and facial pain during this whole time period. Most recently, saw ophthalmologist who started treatment for very dry eyes.
26 2021-07-27 migraine Still experiencing severe muscle pain in right leg and left arm (arm was vax site); Severe migraine;... Read more
Still experiencing severe muscle pain in right leg and left arm (arm was vax site); Severe migraine; Flu-like symptoms; Diarrhea; Nausea; Temperature regulation issues; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 7533) via an unspecified route of administration in the left arm on 04Apr2021 at 17:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Information on medical history and known allergies was not available. Information on whether the patient had received any other medications in two weeks was not available. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6203) via an unspecified route of administration in the left arm on 13Mar2021 at 13:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Prior to the 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 did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 08:00 the patient was still experiencing severe muscle pain in his right leg and left arm (arm was vax site), severe migraine, flu-like symptoms, diarrhea, nausea, and temperature regulation issues. The patient did not receive any treatment for the adverse 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 of the events severe muscle pain in right leg and left arm (arm was vax site), severe migraine, flu-like symptoms, diarrhea, nausea, and temperature regulation issues was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
26 2021-07-27 pain in extremity, cold sweat Cold sweats; Body aches; Dehydrated; Sore arm; Headache; This is a spontaneous report from a contact... Read more
Cold sweats; Body aches; Dehydrated; Sore arm; Headache; This is a spontaneous report from a contactable pharmacist. A 26-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on an unspecified date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient woke up in middle of the night after receiving vaccine the previous day (as reported) with cold sweats, body aches, headache all morning, sore arm and dehydrated. The adverse events were starting to subside then. The clinical outcome of the event cold sweats, body aches, headache, sore arm and dehydrated was recovering at the time of this report. No follow-up attempts are needed; information about lot number cannot be obtained.
26 2021-07-27 pain in extremity experienced Flu; Joint Paint; Fever; Muscle Pain; Headache; Tiredness; Nausea; Arm Pain; Injection S... Read more
experienced Flu; Joint Paint; Fever; Muscle Pain; Headache; Tiredness; Nausea; Arm Pain; Injection Site Pain; He is feeling sick after second dose; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program . A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 20May2021 (at the age of 26-years-old) (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 previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date (at the age of 26-years-old) for COVID-19 immunisation. The patient reported that he experienced Flu, Joint Paint, Fever, Muscle Pain, Headache, Tiredness, Nausea, Arm Pain and Injection Site Pain. He had his first shot of the Pfizer BioNTech Covid-19 Vaccine last day 20May2021 (as reported). Caller wanted to know if he would be allowed to take Dayquil to relieve the current side effects he was experiencing. The patient received his second dose last day (20May2021) but cannot recall exact date of 1st. He was feeling sick after second dose. His symptoms were not much different than what was on the fact sheet. He did not wish to report them at all. He just had a question. His symptoms were very typical of the flu with the usual joint pain, fever, muscle pain, headache and tiredness. He took the day off of work. He just wanted to know if he should take Dayquil tomorrow so he could function and go to work. The patient was referred to HCP. Outcome of the events was unknown. Follow-up needed. Information about batch/lot number has been requested.
26 2021-07-28 burning sensation On saturday(7/3/2021) the day after the vaccine instatted already having chest pain. Three days(7/6/... Read more
On saturday(7/3/2021) the day after the vaccine instatted already having chest pain. Three days(7/6/2021) after the chest pain I started having chest palpations and felt a ball in my chest with tightness. I went to the ER and they diagnosed me with pericarditis. I'm still dealing with it 3 weeks later and cant exercise at all. Before i was a very healthy individual and ran 15 miles a week. Now im not able to jog for 2 minutes without a burning sensation on the left side of my chest. At night i constantly get chest pains. Ive been taking the medication ibuprofin 3 times a day and cholichine 1 time a day. Its gotten slightly better in terms of pain but I am still unable to perform any physical activities that raise my heart rate.
26 2021-07-28 pain in extremity, numbness, electric shock sensation, tingling March 20 2021 (shortly after 2nd Pfizer COVID19 vaccine March 17 2021, injected into LEFT arm): woke... Read more
March 20 2021 (shortly after 2nd Pfizer COVID19 vaccine March 17 2021, injected into LEFT arm): woke up with burning, throbbing, RIGHT neck, shoulder, RIGHT arm pain for 3-4 hours -- > numbness/tingling RIGHT shoulder to fingertips; dysesthesias to extremes of temperature in RIGHT arm; RIGHT hand>arm weakness and dexterity issues; dizziness with fast lateral movements that occurred a little bit later Pain went away in a few days, but still has residual numbness and tingling (even now) Dysesthesias to temperature lasted a few weeks -- > MRI brain noncontrast March 29 2021 showed lesions c/f MS in the supra and infratentorium -March 30 2021: L'hermitte's sign (shock or vibration) from abdomen to feet when looking down -- > steroids not given initially, as sx on neuro exam felt to be mild -- > MRI C/T spine April 21 2021 with RIGHT C2-C3 nonenhancing lesion; repeat brain showed no enhancement -- > ACE slightly elevated; CT chest without LAN -- > April 23 2021 decided to order IV steroids given mild RIGHT hand weakness, given April 27-29 2021 -- helped, but still has numbness and tingling; it's getting easier to write and use a pipetter, but still some difficulty IMPRESSION: This is a 26 Y man with CIS, one neurological event mostly causing RIGHT hand weakness and sensory sx plus vertigo that happened 3 days after a 2nd COVID19 vaccine. He meets criteria for dissemination in space (spine, brainstem, and PV lesions) but does not meet dissemination in time (no contrast enhancing lesions, no change in brain lesions over 1 month of monitoring). A LP is required to finalized criteria to discriminate between CIS and RRMS. Elevated ACE and ANA are common to see in MS, and I do not think they point to further pathology.
26 2021-07-28 tingling Since receiving the vaccine, my fingertips underneath the fingernails all felt as though they had fr... Read more
Since receiving the vaccine, my fingertips underneath the fingernails all felt as though they had frostbite/tingling on and off. This has reduced in effect over time. I have developed strong chest discomfort and a cough exactly 48 hours after receiving my second dose.
27 2021-01-04 weakness Body ache, headache, body weakness, fatigue
27 2021-01-04 cold sweat Patient presented to receive COVID-19 vaccine (Pfizer) at approximately 1621. Patient waited 15 minu... Read more
Patient presented to receive COVID-19 vaccine (Pfizer) at approximately 1621. Patient waited 15 minutes when asking to leave was asked if she had any symptoms, patient reported headache. NP asked patient to lay down in stretcher and took repeat vitals which showed elevated BP. Patient reported feeling clammy had palpitations. NP made decision to call EMS. EMS arrived and transported patient to ED at 1735.
27 2021-01-06 seizure, migraine Fever as high as 101.6, body aches, severe pain at injection site, convulsions/chills, nausea, cough... Read more
Fever as high as 101.6, body aches, severe pain at injection site, convulsions/chills, nausea, cough, migraine
27 2021-01-09 tremor 104.0° fever, shaking. Started approximately 12 hours after second dose. Lasted for 6 hours then w... Read more
104.0° fever, shaking. Started approximately 12 hours after second dose. Lasted for 6 hours then went away. Following night, fever of 101.9° and slight shaking. Chest pain. Oxygen saturation still at 97%
27 2021-01-10 nerve pain, pain in extremity, concussion, weakness, mild one side paralysis Nerve pain left arm to shoulder and ring and pinky finger weakness in l hand and arm pain and heart;... Read more
Nerve pain left arm to shoulder and ring and pinky finger weakness in l hand and arm pain and heart; concussion symptoms, severe headaches, body weakness and disorientation, lights bright and sensitive. ER visit 1/9/2021 - ER referral to Ortho Spine. Continuing pain radiates to different degrees l arm to hand to include burning shoulder pain, concussion symptoms, severe headaches, body weakness and disorientation, lights bright and sensitive.
27 2021-01-11 feeling cold Began to feel really cold; Muscle pains; Joint pains; Throbbing headache; Fever of 101.7F; Shivering... Read more
Began to feel really cold; Muscle pains; Joint pains; Throbbing headache; Fever of 101.7F; Shivering chills; Second dose of BNT162b2 was given 17 days after 1st dose; This is a spontaneous report from a contactable physician, the patient. A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Jan2021 11:15 AM (at the age of 27-years) as a single dose (Lot Number EK9231) for COVID-19 immunization. Medical history included asthma and no 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 had previously received the first dose of BNT162B2 via an unspecified route of administration in the left arm on 18Dec2020 12:00 PM (at the age of 27-years) as a single dose (Lot Number EH9899) for COVID-19 immunization. The patient had not received any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 04Jan2021, approximately 10-12 hours after 2nd dose of vaccine the patient began to feel really cold, had some mild muscle pains, joint pains, and a headache. Overnight these symptoms worsened to severe muscle pains, joint pains, and a throbbing headache, shivering chills, took a temperature and had a fever of 101.7F. These symptoms did not subside until late the next morning. The headache had persisted. The patient reported taking paracetamol (TYLENOL) 1000 mg, which helped. The outcome of the events feels really cold, muscle pains, joint pains, throbbing headache, shivering chills, fever of 101.7F, were reported as recovering.
27 2021-01-12 bell's palsy R sided Bell palsy
27 2021-01-12 burning sensation, numbness, tingling A few hours after my second dose on 1/08/2021, I had some adverse reactions that worried me, includi... Read more
A few hours after my second dose on 1/08/2021, I had some adverse reactions that worried me, including arm numbness, tingling around my mouth and cheeks, a splitting headache/blurry vision, joint and muscle pain and dizziness. I called e-medicine and had a video call with a E-Medicine provider who told me to keep monitoring my symtoms and go to the ER if they got worse (fortunately they didn't); however there are some lingering effects. Currently I still am experiencing headaches (around my ears and temple area) with joint pain/body aches and occasional tingling/burning sensations in my fingers and feet.
27 2021-01-13 pain in extremity, night sweats Around 7 pm I started feeling really anxious. I checked my HR on my smart watch and it said that aro... Read more
Around 7 pm I started feeling really anxious. I checked my HR on my smart watch and it said that around 12pm my HR was 157bpm which was right after getting the vaccine when I started walking home. My resting HR is usually 47-52bpm. I am a very active person. I have been waking up in the middle of the night multiple times in night sweats and it feels like my heart is contracting very hard. I notice that my HR jumps up right when I start to be more active, but more than normal. On the 11th my average walking HR was 140. Today at work my HR was 134 at the highest around 9am and the lowest was 56bpm around 7am when I was getting ready for work. Additionally to the increased HR I have SOB when I walk and talk. I did have a sore arm as well the first day, but nothing more than any other injection I have had before.
27 2021-01-13 seizure, migraine Fever, uncontrolled convulsions, rapid cycling of body temperature for roughly 48 hours, migraine, i... Read more
Fever, uncontrolled convulsions, rapid cycling of body temperature for roughly 48 hours, migraine, intense body pain and lethargy, inability to sleep, no appetite
27 2021-01-14 tremor Fever as high as 101.6, chills and shakes lasting almost 8 hours. Currently shaking has subsided and... Read more
Fever as high as 101.6, chills and shakes lasting almost 8 hours. Currently shaking has subsided and fever/chills starting to break after some rest and Advil
27 2021-01-17 tenderness Multiple left supraclavicular lymph node enlargement. Tender to touch. Started on 01/12/2021, has ... Read more
Multiple left supraclavicular lymph node enlargement. Tender to touch. Started on 01/12/2021, has increased slightly. On 01/18/2021, felt an additional lymph node.
27 2021-01-18 weakness Symptoms began at 06:00 on 1/19/21 and included fever, chills, weakness, aches, injection site pain.... Read more
Symptoms began at 06:00 on 1/19/21 and included fever, chills, weakness, aches, injection site pain. Tylenol taken. Notified employee health at the facility.
27 2021-01-18 tingling Tingling on the face in the left side. Headache. Fatigue
27 2021-01-20 pain in extremity Chills, fatigue, body aches, left arm pain, was unable to sleep. Headaches. Symptoms lasted for abou... Read more
Chills, fatigue, body aches, left arm pain, was unable to sleep. Headaches. Symptoms lasted for about 24 hours.
27 2021-01-21 inability to speak, tremor Started shaking uncontrollably Fever got up of 105.6 Was unable to speak
27 2021-01-21 hot flush About 12 hours post-injection I began noticing hot/cold flashes and running a fever. Between 10:30pm... Read more
About 12 hours post-injection I began noticing hot/cold flashes and running a fever. Between 10:30pm and noon on January 22nd, 2021 I've experienced continued hot/cold flashes, fever, nausea, muscle aches, injection site pain, congestion, headache, and minor swelling and pain of the lymph nodes in my left axilla area. So far the fever seems to have broken with Tylenol, water, and rest. Still experiencing significant muscle aches, left axilla pain, headaches, congestion, and general fatigue.
27 2021-01-24 facial paralysis, bell's palsy Received the first COVID shot on 1-17-21 and began to feel pain in the back of my neck on the right ... Read more
Received the first COVID shot on 1-17-21 and began to feel pain in the back of my neck on the right side in the afternoon of 1-19-21. On 1-20-21 I lost part of my taste and neck started to cause headaches. On 1-21-21 symptoms continued to get worse. On 1-22-21 I began to lose control of the right side of my face. Face began to droop and eye was unable to close. I went to the ER on the evening of 1-22-21 and was diagnosed with Bell's Palsy.
27 2021-01-24 night sweats Chills, fever, body aches, headache, fatigue, night sweats. Lasted approx 24 hours after second dose... Read more
Chills, fever, body aches, headache, fatigue, night sweats. Lasted approx 24 hours after second dose.
27 2021-01-26 feeling jittery PATIENT REPORTS SYMPTOMS OF FEELING JITTERY, ELEVATED BLOOD PRESSURE 149/109 AND HR 107 AND CHEST SO... Read more
PATIENT REPORTS SYMPTOMS OF FEELING JITTERY, ELEVATED BLOOD PRESSURE 149/109 AND HR 107 AND CHEST SORENESS.
27 2021-01-26 seizure Got him up in the morning after he had gotten the vaccine the day before. Sa t him down on the toil... Read more
Got him up in the morning after he had gotten the vaccine the day before. Sa t him down on the toilet and he immediately had a major seizure. Came out of it, let him sit for 5 minutes, got him up and sat on the chair, gave some juice and water, and he was back to normal. He had diarrhea the day of the vaccination and the day before.
27 2021-01-27 bell's palsy, numbness, facial paralysis Vaccine given 01/17 R-sided neck pain 01/19 Decreased taste, tongue numbness right sided 01/20 Lip a... Read more
Vaccine given 01/17 R-sided neck pain 01/19 Decreased taste, tongue numbness right sided 01/20 Lip and facial numbness right sided 01/21 Droopy right eye and face 01/22 ED on 01/22, given 7 day course of prednisone and valtrex Ongoing right sided facial droop, right sided eyelid droop. Unable to close right eye fully. Eye dryness. Diagnosed with Bell's Palsy in ED, confirmed in clinic
27 2021-01-28 bell's palsy, facial paralysis Bells Palsy was diagnosed at hospital at the ED was prescribed steroid, antiviral, and pain medic... Read more
Bells Palsy was diagnosed at hospital at the ED was prescribed steroid, antiviral, and pain medication for up to 10 days and it has only been 5 days since then. The only improvement seen is that the head pain in the back of the ear has gone but the right side of the face being droopy is still the same.
27 2021-01-31 flushing When patient was in for his 2nd dose, reported that an hour after the first vaccination was given he... Read more
When patient was in for his 2nd dose, reported that an hour after the first vaccination was given he felt like his heart rate was high. No measurement was ever taken to confirm it was in fact high. He also became flushed. He was wearing a sweatshirt, so when he took that off he was feeling better. This episode lasted for 5 hours. No comorbidities or other heart conditions. We asked if he was possibly dehydrated or had any caffeine that day. I determined to proceed with dose 2 under the request that he came back after 1 hour and 2 hours respectively to get vitals.
27 2021-02-03 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Headache, chills, sore arm, low grade fever for 2 days followin... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Headache, chills, sore arm, low grade fever for 2 days following administration starting 12 hours after vaccine. 2.5 days later, I got upper lip angioedema that resolved within 1 day with Benadryl and Zyrtec
27 2021-02-04 discomfort Woke up middle of night sweating with 200+ BPM heart rate. Blood pressure 190/100. Weight on chest. ... Read more
Woke up middle of night sweating with 200+ BPM heart rate. Blood pressure 190/100. Weight on chest. Felt dizzy and faint. Could hardly walk. Labored breathing. Had to call ambulance for transport to hospital.
27 2021-02-07 weakness Vertigo; 101 F oral temperature; nausea; generalized weakness; rigors/ chills; generalized muscle ac... Read more
Vertigo; 101 F oral temperature; nausea; generalized weakness; rigors/ chills; generalized muscle aches; This is a spontaneous report from a non-contactable Nurse (patient). A 27 years old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 27 years old on 21Jan2021 09:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Vertigo, 101 F oral temperature, nausea, generalized weakness, chills, rigors, generalized muscle aches. Patient did not have covid prior vaccination and did not have covid tested post vaccination. The outcomes of events were unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
27 2021-02-08 feeling of body temperature change Pt received first dose Pfizer COVID 19 vaccine 26JAN21 at approx 0830. Pt reports yesterday 2330 we... Read more
Pt received first dose Pfizer COVID 19 vaccine 26JAN21 at approx 0830. Pt reports yesterday 2330 went to pee and was feeling tired. Became nauseated and then started quickly oscillating between feeling hot and cold. Sat up in bed and when he did, felt ''everything move to my toes''. Remained conscious for about 2-3 seconds and then woke up on the floor in a pool of sweat about 5 minutes later (knows the timespan based on looking at his watch when he went to the bathroom and when he woke up). Tried to get up and felt unstable so decided to lay in the floor which he did for about another 10 minutes. During this timeframe, noticed jaw pain and soreness which he attributes to clenching his jaw. At this point, able to struggle into his bed and noted that the oscillation of hot/cold had abated and he was left with a mild headache and fatigue which has slowly improved since that time. At this time, pt reports he feels about 90% of USOH but somewhat ''uneasy'' still. Denies reaction to medication or vaccine in the past other than sulfa abx for which he had skin rashes as a child.
27 2021-02-16 pain in extremity, migraine Migraine-like headache started at around noon, got worse at 2pm, slept from 3-6, still had headache.... Read more
Migraine-like headache started at around noon, got worse at 2pm, slept from 3-6, still had headache. began feeling nauseous, vomited at 8pm. Took Tylenol and slept at 11pm, feeling OK with sore arm now.
27 2021-02-21 tenderness Patient presented to Urgent Care 3 days after his second dose of Pfizer COVID-19 vaccination.. He re... Read more
Patient presented to Urgent Care 3 days after his second dose of Pfizer COVID-19 vaccination.. He reported a 10 day issue of a left axilla mass (12 cm) with new onset of tenderness.
27 2021-02-24 pain in extremity Patient verbalized "scratchy" dry throat, feeling of swelling to lips, throat, tongue. Bilateral arm... Read more
Patient verbalized "scratchy" dry throat, feeling of swelling to lips, throat, tongue. Bilateral arm soreness. Headache. Vitals taken and stable. 10mg Zyrtec given. Patient feeling less swelling to lips, and throat. Vitals before discharge BP 132/73, HR 87%, O2 99%. Discharged home ambulating and stable.
27 2021-03-04 feeling hot, unresponsive to stimuli, seizure like phenomena After vaccine pt went to observation area .He felt hot and asked staff for H2O. When staff returned ... Read more
After vaccine pt went to observation area .He felt hot and asked staff for H2O. When staff returned c H2O he stated he felt light headed. Staff concerned he was going to pass out so they assisted him from chair to ground with legs e levated . Emergency number and onsite MDcalled . Pt was unresponsive c aBormal breathing and seizure like activity . Epi 0.3mg administered in right thigh. Pt became responsive and breathing 15 RR a minute. Pt diaphoretic c rash on upper extremities. VSS. EMS arrived and transported pt to local ED for evaluation.
27 2021-03-04 numbness, pain in extremity, tingling Patient is a 27 year old male with no significant medical history presents to MC on 2/6 from Urgent ... Read more
Patient is a 27 year old male with no significant medical history presents to MC on 2/6 from Urgent Care for further evaluation of chest pain. He states that he woke up at 5:30am with abrupt onset of chest pain with present like quality in the middle of the chest. It was non-radiating with associated nausea, small amount of emesis, and dyspnea. His pain lasted for about 15 minutes and he started experiencing it again after half an hour with numbness and tingling of his bilateral distal digits and diaphoresis. He decided to seek evaluation at local Urgent Care around 7:30am. States that he was immediately send here through ambulance due to findings of EKG changes. He was given aspirin and nitroglycerin with some alleviation of pain. Currently, he feels little better although continues to have chest pressure substernally every 45 minutes lasting 5-10 minutes. His dyspnea is resolved. He does not have pleuritic chest pain, fever, chills, nausea, vomiting, abdominal pain, diarrhea, leg swelling, rash. Additionally, he has been in normal state of health until this 2/2/21 when he received second dose of COVID-19 (Pfizer) vaccine. He had extreme fatigue with left arm soreness. He reports no sick contacts, recent illness, or travel. MRI cardiac done 2/9/21 with assessment reveals Infero-lateral myocarditis. Patient remained hemodynamically stable and was discharged with ibuprofen taper for 10 days, c/w colchicine 0.6 mg QD x 3 months and pantoprazole 40 mg QD
27 2021-03-04 unresponsive to stimuli, seizure like phenomena, feeling hot After vaccine, pt went to observation area. He felt hot and asked staff for water. Staff returned wi... Read more
After vaccine, pt went to observation area. He felt hot and asked staff for water. Staff returned with water and he stated he felt light headed. Staff concerned pt might pass out so they assisted him to floor with feet elevated. 911 and onsite MD and EOA called. Pt was unresponsive with agonal breathing and seizure like activity. Epi 0.3 mg administered IM into right thigh. Pt became responsive and breathing 15 RR a minute. Pt remained diaphoretic with rash noted on upper extremities. VSS. EMS arrived and transported pt to local ED for further evaluation.
27 2021-03-05 speech disorder Cough, pale, diaphoretic, non-verbal, dry heaved. Evaluated by EMS, cleared.
27 2021-03-09 feeling hot Feeling hot; abnormal, blurred vision
27 2021-03-10 hot flush Warm flush feeling, sweating, nausea, and diarrhea starting 3 hours after vaccine lasting for 24 hou... Read more
Warm flush feeling, sweating, nausea, and diarrhea starting 3 hours after vaccine lasting for 24 hours
27 2021-03-10 seizure Immediately after he said he was dizzy. I had him remove his mask and take some deep breaths. He did... Read more
Immediately after he said he was dizzy. I had him remove his mask and take some deep breaths. He did. I called for help from other nurses in the room. He had seizure activity and fell from the chair to the floor. In the process he hit his head on the table. He had his stocking hat on. The other nurses were there immediately. Talking to him, reassuring the mom, BP, pulse oximeter, ice pack, privacy curtains in place. He was offered food and drink. Other staff removed others from the room. The ambulance was called. And arrived. The ambulance assessed him. Education and instruction were given. They asked him to go to ER. He refused. They advised him to see his Doctor. The ambulance had him sign their needed paperwork. Helped him to his feet, he refused to use their cart provided. He said, I am fine. He was strongly encouraged to follow up with his Doctor. He walked out of the room with ambulance personal and his mom.
27 2021-03-11 feeling hot Pt. was vaccinated by another pharmacist at our remote clinic at an elementary school at 11:35am 3/1... Read more
Pt. was vaccinated by another pharmacist at our remote clinic at an elementary school at 11:35am 3/11/21. Within less than 3 minutes the patient informed a student that he did not feel well. He reported: itching, feeling hot, shortness of breath, dizziness, loss of vision, and thirst. The student alerted me and I assessed the pt. He was responsive, but felt "tired". He was sitting on the floor. I told the student to call 911. I continued talking with the pt. as I was preparing the epinephrine and placing a blood pressure cuff on his arm. He became less responsive and asked me for the epinephrine. I injected him with an EpiPen 0.3mg in his outer left thigh through his pants (at 11:43am). Within approximately 30s-1min the pt. became more responsive. I then took his pulse and BP shortly before EMS arrived (11:52am) . They performed the second blood pressure reading and the pt. was transferred to their care at that point.
27 2021-03-14 muscle spasms Gi Issues, intense sharp cramps, diarrhea
27 2021-03-16 night sweats Fever (101.5 F), chills, night sweats, injection site soreness, headache
27 2021-03-17 seizure Systemic: Seizure-Severe
27 2021-03-17 unresponsive to stimuli 1242: Vaccine administered. 1255: RN called to assist with patient. Caregiver stated that the pati... Read more
1242: Vaccine administered. 1255: RN called to assist with patient. Caregiver stated that the patient reported that he "felt funny" and "feel like I can't breathe." Caregiver stated that the patient was no longer responding to questions being asked. Caregiver reported not being able to arouse the patient after shaking his leg twice an no response. Caregiver stated that excess secretions from mouth is normal. 1255: Patient responding to questions being asked. Heart rate 123 beats per minute and oxygen saturation level 99% on room air via pulse oximeter. Lungs clear to ausculation. Patient sitting power chair. 1257: Apical heart, regular with a rate 100 beats per minute. 1258: Unalbe to obtain blood pressure in left arm due to tone. 1259: Blood pressure in right arm 168/92. 1303: Blood pressure in right arm 158/98. 1309: Patient reports feeling better at this time. Patient with caregiver. Caregiver verbalized appreciation.
27 2021-03-23 tenderness Woke up this morning and my armpit on the side that I received the shot was slightly swollen and ten... Read more
Woke up this morning and my armpit on the side that I received the shot was slightly swollen and tender.
27 2021-03-24 weakness, flushing Headache, swollen muscles, dizziness, blindness, sweating, flushing, feeling dehydrated, weakness, m... Read more
Headache, swollen muscles, dizziness, blindness, sweating, flushing, feeling dehydrated, weakness, muscle fatigue, eye soreness, sore neck.
27 2021-03-24 weakness, pain in extremity The female medical employee, who was administering the vaccination. The Pfizer Vaccination. Opened ... Read more
The female medical employee, who was administering the vaccination. The Pfizer Vaccination. Opened a shot syringe. That had an empty vile. The syringe did not have the dosage of vaccine. The female medical employee, documented on my immunization card the sticker Lot number #EN6204, but the vaccine Lot Number (the syringe received) was not the Lot Number indicated on the immunization card. Why? The female medical employee, called over the military personnel whom was being the security for the vaccination site. The female military personnel was holding an open unit syringe vile dosage of the vaccine. The female medical employee showed the empty syringe vaccine to the military personnel. She said, "The dosage fell out." The female medical employee, took the open package, of the syringe vile, that contained a measured dose of the vaccine. Which is not considered the full dosage, or considered a safe dosage of the vaccine, because the package was opened. Not in front of the patient. And. Was open, when the military personnel, who was holding this vile, was walking, with the open package, around without proper medical gear. The medical employee. Quickly took out the syringe. Didn't explain which and what that syringe was, and just injected the dosage into my arm. I know, that practice was malpractice. I know I experienced malpractice. And. It's obvious the Government is going to do anything about it. This is not a petty situation. I don't know where that needle from. What has been introduced to that open syringe package. I did experience very bad side affects: headaches, muscle pains, tiredness, fatigue, weakness, low strength, dizziness, partial blindness, overwhelming stress, back pain, joint pain, spinal pain, chills, fever like symptoms, nausea, spontaneous pain, soreness in the arm, swelling throughout my body, difficulty breathing, short breaths.
27 2021-03-25 tingling Nausea Paresthesia Lightheaded Sweating 1x emesis
27 2021-03-26 flushing Flushing/sweating, light-headed. Vitals wnl. Anxious about shot.
27 2021-03-27 feeling cold Tuesday evening sour throat developed. Wednesday morning sour throat had progressed had progressed ... Read more
Tuesday evening sour throat developed. Wednesday morning sour throat had progressed had progressed and sinuses became congested. Thursday by noon severely congested, constant cough, and cold shivers (still cold and shivering under two layers of blankets, heater on, wearing pants, shirt, and jacket). Eat foods high in potassium and vitamins A and C. Take 24 hour decongestant pill. Ibuprofen for headache resulting from cough. Friday abnormal coldness gone, slightly less painful throat, slightly less congested. Eat foods high in potassium and vitamins A and C. Take 24 hour decongestant pill. Ibuprofen for headache resulting from cough. Saturday Throat less sour, less congested, and cough less persistent. Ibuprofen for headache resulting from cough. Sunday so far (as of 7:43am) same level of congestion, sourness, and cough as Saturday.
27 2021-03-30 migraine Ongoing migraine x6 days following vaccine
27 2021-03-30 seizure had a major seizure on day 8 of dose one despite nearly no history of seizures; I was tired after th... Read more
had a major seizure on day 8 of dose one despite nearly no history of seizures; I was tired after the first dose (26Feb2021) on days 2-3; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in arm left on 26Feb2021 15:00 (Batch/Lot Number: EN6204) as SINGLE DOSE for COVID-19 immunization at doctor's office/urgent care. Medical history included atypical trigeminal neuralgia since 2009, complex regional pain syndrome (CRPS), attention deficit hyperactivity disorder (ADD), anxiety, depression, asthma, Epilepsy-prone and many more. The patient also had orthopedic knee surgery on 26Aug2020 which she had pain after surgery. She also had known allergies with Cephalosporins and elemental nickel. Concomitant medications included tapentadol (TAPENTADOL), amphetamine (AMPHETAMINE), and candesartan cilexetil, hydrochlorothiazide (CANDESARTAN HCTZ) all taken for unknown dates and indications. The patient stated that she was tired after the first dose (26Feb2021) on days 2-3 (Feb2021). She also had had a major seizure on day 8 of dose one (07Mar2021) despite nearly no history of seizures which require emergency room/department or urgent care visit. The seizure has been attributed to other issues by her doctor. The patient had no COVID-19 prior vaccination and was not tested post vaccination. The events were considered life threatening. The patient did not receive any treatments for the events. The patient recovered on unknown date in 2021.
27 2021-03-31 tingling, numbness patient complains of having nerve numbness and tingling from elbow down on same arm that he received... Read more
patient complains of having nerve numbness and tingling from elbow down on same arm that he received his vaccination
27 2021-04-01 pain in extremity I had very minimal symptoms after my shot, within 48 hours my slight arm pain had gone away About ... Read more
I had very minimal symptoms after my shot, within 48 hours my slight arm pain had gone away About a week later in the early morning of 4/2/21 I woke up feeling very fatigued and feverish. My symptoms continue to be a low grade fever, fatigue, headache, and sore throat.
27 2021-04-01 trigeminal neuralgia pain on the first day after the second vaccine dose was as bad as it was the first day after surgery... Read more
pain on the first day after the second vaccine dose was as bad as it was the first day after surgery; my atypical trigeminal neuralgia (had since 2009) was as bad as it has ever been; my atypical trigeminal neuralgia (had since 2009) was as bad as it has ever been; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received bnt162b2 (Pfizer/Bio-N-tech COVID vaccine), dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 13:15 (Batch/Lot Number: EN6203) as single dose for COVID-19 immunization. Medical history included major orthopedic knee surgery on 26Aug2020, atypical trigeminal neuralgia since 2009. The patient had pre-existing pain issues that also continued to be elevated on the 2nd and 3rd day after surgery but not nearly as bad as the first. The patient has known allergies to cephalosporins and elemental nickel. Other medical history: complex regional pain syndrome (CRPS), attention deficit hyperactivity disorder (ADD), anxiety, depression, asthma, epilepsy-prone, many more; rest will be provided if full list is needed. The patient was not diagnosed of COVID prior vaccination and has not been tested for COVID post vaccination. Concomitant medication included tapentadol, amphetamine and candesartan cilexetil, hydrochlorothiazide (CANDESARTAN HCTZ); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient had the 1st dose of bnt162b2 (Pfizer/Bio-N-tech COVID vaccine), via an unspecified route of administration, administered in left arm on 26Feb2021 03:00 PM (Batch/Lot Number: EN6204) as single dose for COVID-19 immunization. The patient was tired after the first dose on days 2-3, and had a major seizure on day 8 of dose one despite nearly no history of seizures but that has been attributed to other issues by his doctor. The patient had a major orthopedic knee surgery on 26Aug2020 and his pain on the first day after the second vaccine dose (after getting the dose on 19Mar2021, going to bed, and waking up the next day) was as bad in Mar2021 as it was the first day after surgery, and his atypical trigeminal neuralgia (had since 2009) was as bad in Mar2021 as it has ever been. The patient mentioned he would advise and recommend for patients to speak to their doctors before the second dose to obtain a few days of higher dose pain medication. The events resulted in: emergency room/department or urgent care and was considered serious due to life threatening illness (immediate risk of death from the event). No treatment given for events. Outcome of events recovered.
27 2021-04-02 cold sweat, flushing, seizure, tremor, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: unconscious for less than a minute.Has a history of fainting from many years ago but no incidents since.Epi pen given 4:10p and 911 called. Paramedics arrived ~4:18p.Bp was 110/80 @4:13p, 128/88 @ 4:18p, 132/86 (pulse 70) @4:21p.Was clamy, shaky, sweaty,and had a headache post.Paramedics monitored sitting and standing.Advised to followup with physician.
27 2021-04-05 cold sweat Shortly after patient received vaccine (within 5 minutes) Patient was sitting in area being monitore... Read more
Shortly after patient received vaccine (within 5 minutes) Patient was sitting in area being monitored for reaction. Patient then fell face forward and hit his face. Aid came helped immediately and patient was monitored for vitals. Patient report to feeling dizzy. He appeared pale and clammy.
27 2021-04-06 feeling hot Feeling lightheaded, very fatigued, and hot. Slight headache.
27 2021-04-06 pain in extremity Dizziness, difficult to concentrate, headache, fatigue, fear of sound and light starting 5 hours aft... Read more
Dizziness, difficult to concentrate, headache, fatigue, fear of sound and light starting 5 hours after vaccination. No treatment, went to bed as usual and symptoms were gone the next morning. Arm soreness lasted for around 1.5 days.
27 2021-04-06 tingling, feeling hot Sweating, intentional breathing, both hands, pins and needles, felt light-headed and hot. All sympt... Read more
Sweating, intentional breathing, both hands, pins and needles, felt light-headed and hot. All symptoms lasted only a few minutes (less than 5).
27 2021-04-06 seizure patient felt dizzy, was unconscious and upon awakening, patient was seizing
27 2021-04-06 tremor The patient felt uncontrollable shakes/chills at night for around 15 minutes before sleeping but rec... Read more
The patient felt uncontrollable shakes/chills at night for around 15 minutes before sleeping but recovered after rest.
27 2021-04-06 unresponsive to stimuli Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting... Read more
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pateint \"swooned\" when the observer was getting the timer. He was responsive after 2 minutes. sat upright after 5 minutes.
27 2021-04-07 cold sweat Patient reported that he "felt like he was going to pass out". Was pale and clammy. Reports hx of ... Read more
Patient reported that he "felt like he was going to pass out". Was pale and clammy. Reports hx of vasovagal response to injections. VSS. Cool air and drink applied. Within 5 minutes color returned and patient reported that he felt much better. Was able to drive self home after 20-30 minutes.
27 2021-04-07 pain in extremity Swollen lymph node in neck since March 24th 2021. I have recently been experiencing muscle fatigue/d... Read more
Swollen lymph node in neck since March 24th 2021. I have recently been experiencing muscle fatigue/dull aching in my left arm, left side of neck, left shoulder, and upper left back.
27 2021-04-07 seizure Patient received immunization and felt fine after sitting in chair for a few seconds. Pt got up and ... Read more
Patient received immunization and felt fine after sitting in chair for a few seconds. Pt got up and went to waiting area and was sitting down in chair during the 15 minute observation window. Pt passed out and slumped/fell out of chair on patients left side. I was called out by the person monitoring the waiting area to see pt in fetal position on their left side seizing. The seizing lasted for about 15 seconds and then stopped. PT was motionless for a few more seconds and then came around and said "I'm back". The pt was given a bottle of water because he said he was thirsty. In the meantime the paramedics were called and arrived. They checked his BP and Blood Glucose. After several minutes they took the pt out on a gurney for further evaluation, there was a question as to whether or not pt hit his head.
27 2021-04-07 unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild
27 2021-04-08 cold sweat Vasovagal event with lightheadedness, diaphoresis, blurry vision. No CP, SOB, palp. No s/sx anaph... Read more
Vasovagal event with lightheadedness, diaphoresis, blurry vision. No CP, SOB, palp. No s/sx anaphylaxis: no hives/rash, wheezing, stridor, throat closing, tongue swelling/itching, N/V/D. VS: BP 95/5Os, HR 50s, SaO2 99% RA, afebrile. Pt clammy, bradycardic. Lung clear, abd soft, no edema. No focal neuro deficits, A&Ox3. Pt laid down on the floor with legs elevated with improvement in symptoms, and BP up to 120s/70s, HR 70s. After ten minutes, felt well enough to sit up, repeat BP while sitting 120/70s, HR 70s. Given water/juice and a snack. After another ten minutes, felt well enough to stand, repeat BP unchanged. Pt monitored for another 30 minute without recurrence of sxs. Pt went home without issue.
27 2021-04-08 tenderness Supraclavicular lymphadenopathy following COVID-19 vaccination. Left supraclavicular lymph node is s... Read more
Supraclavicular lymphadenopathy following COVID-19 vaccination. Left supraclavicular lymph node is swollen and tender to the touch.
27 2021-04-09 speech disorder This vaccine is extremely illegal. Terroristic. I have been having such an extreme headache. Bluryne... Read more
This vaccine is extremely illegal. Terroristic. I have been having such an extreme headache. Bluryness, to the point where I have blindnesss. I am unable to think. My speech is completely off. I try to say something, but what I say is not what I was thinking. Don't you dare say I have something wrong with me, in regards to unable to articulate what I want to say, and what Is actually being said. I understand what is happening to me with this reality. Which is why this vaccine is terroristic. Im going to make it my life endeavored goal to resolve this in legal entities. For that. This is not helping anyone. Causing more pain. And. Allowing the government to lie even more. I hate this Country!
27 2021-04-10 cold sweat General fatigue after 12 hours Increased fatigue around 28 hours Nausea, cold sweats/feeling clammy,... Read more
General fatigue after 12 hours Increased fatigue around 28 hours Nausea, cold sweats/feeling clammy, and fitful sleep after 37 hours
27 2021-04-10 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotensi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Sycope episode
27 2021-04-10 pain in extremity 5 minutes after vaccine there was dizziness which passed after 10 minutes 30 minutes after vaccine... Read more
5 minutes after vaccine there was dizziness which passed after 10 minutes 30 minutes after vaccine there was headache, arm pain, muscle pain all over, fatigue, low grade fever, and sense of taste was altered. A constant metallic taste was in mouth and nothing (mints, brushing teeth, drinking water, etc.) removed it. Metallic taste resolved after 24 hours. Other symptoms lasted about 36 hours.
27 2021-04-11 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Additional Details: Patient felt ... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Additional Details: Patient felt light headness, gave patient water, he ate sour patch kids then he said hes ok but will sit for 30 minutes, but he lost consciouness for about 20 seconds, woke up then started vomitting, we called 911 and EMT came took his vital signs bp 117/91 seems ok but patient refuse to go to emergency room, Patient stayed for another 30 mins, his family came and picked him up. Patient said he will call his PCP if still nausea problem, patient said he fainted with injections before but never violently vomt
27 2021-04-12 weakness When I woke up on Sunday, April 11th, 2021 at around 9am, I have felt like my muscles have been ripp... Read more
When I woke up on Sunday, April 11th, 2021 at around 9am, I have felt like my muscles have been ripped apart, I was sweating, I had labored breathing, and I could not get up for the day. I slept all day, feeling like I had the flu, and was sleeping until 7pm that day. I called out of work when I woke up because I knew on Monday I would not be able to make it, as I felt like I was very tired, lethargic, and sore. This feeling was throughout every inch of my body. I also went to take a shower that day and I had a hard time breathing in the shower, to the point where I had to sit on the edge of the tub, just to make sure I would not pass out from lack of oxygen. This was the scariest sickness I have ever had in my entire life. I literally thought I was going to die. Monday came around and I felt even worse, my muscles were sore, I felt extremely tired, I could not do anything, and I was in bed all day. Today is Tuesday, and I have felt a little bit better, but I have missed two days of work because of the effects this vaccine has had on my body. I made a virtual appointment with a doctor on the app on phone and met with Doctor who basically told me that the only thing I could do for myself is take Ibuprofen every 8 hours for the pain and swelling that might occur and drink plenty of gatorade. It is Tuesday, April 13th, 2021 at 11:29pm at night and I still feel the same as Monday, very weak, tired, and sore all over my body. I have never had this with a vaccine before, until I got the COVID-19 one. I have taken the Flu Vaccine, Hep A, Tantnius, Chicken Pox and never felt like I was so tired I could not get out of bed from these vaccines.
27 2021-04-12 involuntary muscle movements, seizure, muscle twitching Patient walked to waiting area and when he sat down he fainted, hit his head, and started having sei... Read more
Patient walked to waiting area and when he sat down he fainted, hit his head, and started having seizure-like activity (jerky, twitchy). Patient was down about 15 seconds and when he sat back down his blood pressure was 74/48 and his vision was black. Called EMT, patient refused to go with EMT, because he felt better after 30 minutes of sitting
27 2021-04-12 seizure Patient fainted and exhibited seizure-like activity within 15 minutes of vaccination. Patient was t... Read more
Patient fainted and exhibited seizure-like activity within 15 minutes of vaccination. Patient was transported to ER by EMS.
27 2021-04-13 seizure like phenomena Syncope with seizure like activity. Bradycardia and hypotension, HR 30-40 BMP
27 2021-04-13 tenderness, burning sensation Approximately 6 days after my second dose, I began getting red splotchy bumps on my left forearm. 7 ... Read more
Approximately 6 days after my second dose, I began getting red splotchy bumps on my left forearm. 7 days after the 2nd dose these spots had spread up my arm and were appearing on my left Tricep area and shoulder. The lesions are tender to the touch with a mild burning sensation, they are mildly itchy.
27 2021-04-14 bell's palsy, facial paralysis 4/10/2021 experienced some right side facial paralysis upon waking. Called urgent care who directed... Read more
4/10/2021 experienced some right side facial paralysis upon waking. Called urgent care who directed me to go to a hospital as soon as possible and asked about all events leading up to this, noting that the vaccine may potentially have this side effect, as written in the medical journal. Went to the ER, they put me in stroke protocol, did CAT scan, negative results, blood tests (including for Lyme), MRI to look for tumors after the CAT scan was negative, and an echocardiogram as they detected a new heart murmur never present before. MRI showed Bell's palsey in one facial nerve, all other tests are negative, including for Lyme's disease, a common cause. I am still experiencing it, and am on Valtrex (anti viral) and Prednisone, but the symptoms still exist. There is no other change in my life or health, the only thing I've done differently is have the vaccine (for which we are grateful).
27 2021-04-14 bell's palsy Bell's palsy, took prednisone and acyclovir
27 2021-04-14 feeling hot Patient states feeling lightheaded, hot, and nauseous while waiting 15 minutes at the waiting area p... Read more
Patient states feeling lightheaded, hot, and nauseous while waiting 15 minutes at the waiting area post vaccination. Upon being assessed by EMS, patient did vomit.
27 2021-04-14 seizure Seizure. Lasted approximately 5 minutes. Outcome was positive and no lingering effects.
27 2021-04-15 discomfort NOTE: Taking Tylenol, Ibuprofen, Diphenhydramine HCL, Clear Eyes Eye drops. Have secere bruising o... Read more
NOTE: Taking Tylenol, Ibuprofen, Diphenhydramine HCL, Clear Eyes Eye drops. Have secere bruising of the eyes. Shortness of breath. Muscle Aches. Joint Aches. Congestion. Mucus buildup. Headaches. Brain noble unstable pressure, and heaviness. Unbalanced and unstable proprioception.
27 2021-04-15 tingling Systemic: Tingling on feet-Medium
27 2021-04-18 weakness Chills, fever, body aches, dizzy, weak
27 2021-04-18 feeling hot, pain in extremity On day 3 following, 2nd dose of Pfizer vaccine, he had right sided calf pain. Initially thought to b... Read more
On day 3 following, 2nd dose of Pfizer vaccine, he had right sided calf pain. Initially thought to be recurence of strain injury, although no history of trauma or obvious trigger. Pain conitnued to worsen and had different characteristics than original strain symptoms. Continued to worsen to point wher eunable to weight bear and swollen, hot and red. Saw orthopedist who refered to vascular surgeon, and on day 13 was officially diagnosed with large DVT extending form tibeal & peroneal, popliteal up to the femoral veins. Has no known clotting defects. Currently under evaluation with hematologist who recommended anticoagulants for remainder of his life.
27 2021-04-18 tingling, speech disorder Client began to complain of feeling dizzy and experiencing tunnel vision right after receiving the v... Read more
Client began to complain of feeling dizzy and experiencing tunnel vision right after receiving the vaccine. Ice pack was applied to back of client's neck. About 5min after receiving the shot the client stated he thought he was going to pass out. 2 RN's walked client to a safe place to lie down. Client began to pass out while walking and was carefully lowered to the floor. Total time unconscious was about 30 seconds. Client began talking though mumbled. About 3 min later client stated he was feeling better. Another 3 min and client moved from laying on the ground to sitting in a chair. He stated he was less dizzy but his arms felt tingly. Client eating crackers and drinking water. Vitals remained stable throughout incident. Client was released to personal vehicle at 1:41pm, walked out of building on his own, gait was steady. Educated pt to request to lie down for 2nd vaccine.
27 2021-04-19 flushing Patient had syncope, dizziness, flushing/sweating, seizure, urinary incontinence. BP 119/79 -- > 103... Read more
Patient had syncope, dizziness, flushing/sweating, seizure, urinary incontinence. BP 119/79 -- > 103/53 -- > 108/50, HR 47 -- > 38 -- > 37 -- > 64 -- > 62, RR 16, O2 100%, Temp 97.3F. EMS called at 17:06, arrived at 17:13.
27 2021-04-19 pain in extremity PATIENT BROUGHT WITH RAPID RESPONSE TO ED FROM VACCINATION ROOM; SYNCOPE IMMEDIATELY AFTER VACCINE S... Read more
PATIENT BROUGHT WITH RAPID RESPONSE TO ED FROM VACCINATION ROOM; SYNCOPE IMMEDIATELY AFTER VACCINE SHOT; PATIENT FELL FROM STANDING AND HIT HEAD ON TABLE; C-COLLAR IN PLACE; PATIENT REPORTS LOSS OF CONSCIENTIOUSNESS; PATIENT STATES HE HAD PAIN TO LEFT SIDE OF HIS ARM; NO SIGNS OF SOFT TISSUE INJURY
27 2021-04-20 pain in extremity Tinnitus Sore arm
27 2021-04-21 weakness Day of shot (4/9), experienced a potential vasovagal reaction and bleeding in the arm. 10 days after... Read more
Day of shot (4/9), experienced a potential vasovagal reaction and bleeding in the arm. 10 days after shot, on 4/19, began to feel very weak and faint, and movement became effortful, along with chills and muscle aches and soreness. This continued into 4/20. Vitals were checked and found to be normal, and by 4/21 symptoms mostly subsided, except for remaining occasional chills and muscle-aches.
27 2021-04-21 numbness 10mins into his observation Client reported feeling itchiness on collarbone and numbness on his ri... Read more
10mins into his observation Client reported feeling itchiness on collarbone and numbness on his right side arm where he had received his vaccine. Client then proceeded to taking his own allergy med that he carries in his bag. Claritin 1 tab 10-15mg. Vitals signs at 3:15pm BP 109/60 HR 60 Respirations 18. He states he is allergic to sulfa, cucumber, avocado, banana which causes him to have an anaphylaxis response. Pt stated he hadn't had anything to eat and a granola bar was provided for him, as well as water. Vital signs BP 130/70 HR 70 RR 18, 3:27pm BP 125/75 HR 71 RR 18. After third set of vitals were taken client reported feeling much better. 3:34pm BP 130/70 HR 70 RR 18 02 97%. Client reported itchiness had gone away. Client was in no respiratory distress and denied having any closing of throat. Client was informed to follow up with his Primary care provider, and emergency precautions were given. He left site in no apparent distress.
27 2021-04-22 cold sweat Post vaccine patient stated his vision began to be blurry and he felt clammy, sweaty and like he w... Read more
Post vaccine patient stated his vision began to be blurry and he felt clammy, sweaty and like he wanted to pass out. Pt was transferred to the observation area. Pt laid down on the stretcher and was given some graham crackers and water. Shortly after the patient stated he was feeling better . Vitals as follows: 1120 SITTING BP 109/74 HR 71 RR 71 SpO2 99; 1124 LYING BP 110/72 HR 74 RR 20 SpO2 99; 1128 BP 104/71 HR 76 RR 20 SpO2 100; 1135 standing BP 107/63 HR 71 RR 18 SpO2 98
27 2021-04-23 pain in extremity Sore arm, Full body aches, fatigue
27 2021-04-23 seizure Systemic: convulsed immediately after getting shot, less than 10 sec, came to in less than 10 sec-Mi... Read more
Systemic: convulsed immediately after getting shot, less than 10 sec, came to in less than 10 sec-Mild, Systemic: Seizure-Mild, Additional Details: he covulsed immediately after injection, staff got him on floor, he awoke in less than 10 sec and was completely aware, knew his name, where he was, and relatively the current time. We had him lay on floor with feet up, he said he felt fine, had normal blood pressure 142/88 hr 89, when emt arrived he felt lightheaded so they took him to hospital, He said no history of seizures, but said does pass out and do this after injections.
27 2021-04-26 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium
27 2021-04-27 seizure Pt had Pfizer vaccine, lost consciousness briefly and had seizure and lost control of bladder. EMS w... Read more
Pt had Pfizer vaccine, lost consciousness briefly and had seizure and lost control of bladder. EMS was called, pt declined to go to ED. Documents were signed and since pt had seizure and lost consciousness, report was filed. Pt was informed. Pt's friend picked up patient. Pt was urged to followed up with PCP and go to ED.
27 2021-04-28 tremor, flushing POST VACCINE, BEGAN TO FEEL FLUSHED, LIGHT HEADED, AND HAD PRE-SYNCOPAL EPISODE, ASSISTED TO FLOOR; ... Read more
POST VACCINE, BEGAN TO FEEL FLUSHED, LIGHT HEADED, AND HAD PRE-SYNCOPAL EPISODE, ASSISTED TO FLOOR; SYNCOPAL TREMORS NOTED BRIEFLY. SPONTANEOUS RECOVERY WITH NO S/S UPON ARRIVAL TO OBS VIA STRETCHER. VSS. ESCORTED TO EXIT WITH NO ISSUES ONCE S/S RESOLVED AT 1700. 1631 BP 160/88 HR 70 RR 12 SATS 100% RA 1653 STANDING BP 144/90 HR 80 RR 16 SATS 98% RA
27 2021-04-28 unresponsive to stimuli Vasovagal syncope Pt fell face first out of the chair approximately 10 minutes post covid vaccine. P... Read more
Vasovagal syncope Pt fell face first out of the chair approximately 10 minutes post covid vaccine. Pt became pale,diaphortic , pupils dilated and non-responsive. No chest rise/fall noted. Nurse could not palpate a pulse. Epi pen administered in right thigh. Pt responded to epi pen and sat up on his own . Emergency alert called overhead on the PA System. ED staff responded and transported pt via stretcher to ED. Pt discharged to home.
27 2021-04-29 weakness, tremor Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Med... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
27 2021-04-29 migraine Migraine Minor body ache Fever 101F
27 2021-04-30 bell's palsy lower right side of his face drooping and unable to move it/ Bell's Palsy; This is a spontaneous rep... Read more
lower right side of his face drooping and unable to move it/ Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8733) via an unspecified route of administration, administered on the left arm on 29Mar2021 11:30 at a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient previously took amoxicillin and experienced allergies. On 10Apr2021 09:00 AM, patient woke up with lower right side of his face drooping and unable to move it. Urgent care advised going to ER, he was put in a stroke protocol, MRI proved it to be Bell's Palsy; ruled out stroke, brain tumors, all blood work normal, echocardiogram normal. No Lyme. No other events or health issues, only change was taking the vaccine. The event resulted in emergency room/department or urgent care visit and hospitalization for 1 day. Therapeutic measures were taken as a result of the event which included valaciclovir (VALTREX) and prednisone (and lots of tests). COVID test post vaccination on 10Apr2021: nasal swab negative. The facility where the vaccine was administered was in a pharmacy or drug store. 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. Outcome of the event was not recovered.
27 2021-04-30 numbness Patient Received his 2nd dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1000 on 4/30/21. Patient ... Read more
Patient Received his 2nd dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1000 on 4/30/21. Patient alerted EMT. Patient stated that he felt that both hands felt numb at around 1032. EMT asked patient to stay extra 30 minutes. EMT reassessed patient at 1107 and patient no longer felt any symptoms. Patient requested for his vital signs to be taken. EMT took vital signs at 1108. BP: 152/92, pulse: 82, O2: 96%. Patient was educated on signs and symptoms of hypertensive crisis and recommended to make appointment to PCP. Patient agreed. Patient left vaccination site unassisted with a steady gait.
27 2021-04-30 migraine, cold sweat Severe migraine, muscle aches, cough, fever, cold sweats and muscle fatigue.
27 2021-04-30 tremor Headache, chills, dizziness, nausea, hands shaking
27 2021-04-30 unresponsive to stimuli Systemic: Fainting/Unresponsive-Severe. Additional Details: Patient had a syncope episode post vacci... Read more
Systemic: Fainting/Unresponsive-Severe. Additional Details: Patient had a syncope episode post vaccine administration. Unresponsive for about 5 minutes. Paramedics were called, patient had recovered from his episode quickly.
27 2021-05-01 weakness Within 5 minutes, I was very sweaty, nauseous and felt like I might pass-out. I was weak. I was told... Read more
Within 5 minutes, I was very sweaty, nauseous and felt like I might pass-out. I was weak. I was told my blood pressure was low. Approximately 15 minutes from the start of symptoms, I rapidly recovered. Within 20 minutes since the shot, I mostly felt normal. The next day and later that evening I felt fine.
27 2021-05-01 pain in extremity, cold sweat Tunnel vision, vomiting, chills, cold sweats, and very close to fainting. These effects occurred at ... Read more
Tunnel vision, vomiting, chills, cold sweats, and very close to fainting. These effects occurred at 3AM the morning after the second dose was administered. Nausea, lack of appetite, arm soreness and fatigue continued through the day. Fatigue continued the day after but the effects seem to be wearing off.
27 2021-05-03 muscle spasms, pain in extremity 1. Sharp Pain in left leg behind knee. Felt similar to nerve pain when leg cramps. Pain occurred ran... Read more
1. Sharp Pain in left leg behind knee. Felt similar to nerve pain when leg cramps. Pain occurred randomly off and on throughout the day. 2. Nausea. Occurred 2-3 times throughout the day. 3. Nose bleed. Occurred 2x on 5/2 and again on 5/4.
27 2021-05-04 cold sweat Fatigue, chills, cold sweats. Low grade fever. Lasted around 15 hours
27 2021-05-04 pain in extremity Left Arm pain starting around 4pm intensifying until plateauing at midnight, May 3rd going into May ... Read more
Left Arm pain starting around 4pm intensifying until plateauing at midnight, May 3rd going into May 4th. Left Arm pain became much more mild by early morning May 4th before resolving completely sometime overnight between May 4th and May 5th. Stiffness and feeling feverish starting around 11pm May 3rd lasting until around 4am May 4th. Slight nausea while standing up starting around 3am May 4th and lasting until around noon May 4th. All symptoms managed at home.
27 2021-05-04 unresponsive to stimuli lost my vision; lost my vision and hearing; essentially unresponsive; feel light-headed; This is a s... Read more
lost my vision; lost my vision and hearing; essentially unresponsive; feel light-headed; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0161), dose 1 via an unspecified route of administration, administered in the left arm on 16Apr2021 at 14:30 as SINGLE DOSE (at the age of 27 years-old) for covid-19 immunisation. Medical history included coarctation of the aorta from an unknown date and unknown if ongoing coarctation of aorta (age: 3 months), only requires bi-annual cardiologist visits, loss of consciousness from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient had no know allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient lost his vision and hearing, essentially unresponsive and light-headed on 16Apr2021 at 14:30. Circulation issues leading to a black out. Within 60 seconds of getting the shot, he began to feel light-headed. Within 30 seconds of that, he knew he needed help, so alerted the emergency medical technicians (EMTs) via car horn/flashers. By the time they arrived (120 seconds from the initial shot), he lost his vision and hearing and was essentially unresponsive. They woke him enough to unlock my car door, at which point they had him lay back to improve his circulation. That ultimately worked and got him back to normal within about 5 minutes. The patient had issues like this before relating to a coarctation of his aorta which he had done at 3 months of age. Over the years, he has "blacked out" like this from weight lifting and other high exertion things. This was the first time it was induced without him overexerting himself, and the onset of the "blackout" was much quicker than what he had experienced from weightlifting. Normally, he could tell 1-3 minutes in advance that he would black out. This time, it was about 30 seconds. Therapeutic measures were taken as a result of lost vision and hearing, essentially unresponsive and feel light-headed. EMTs did an electrocardiogram (EKG) and blood glucose check. The outcome of lost his vision and hearing, essentially unresponsive and light-headed was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
27 2021-05-05 night sweats He received the 1st dose of the Pfizer COVID vaccine on 4/22/21 and within 5 minutes, developed coug... Read more
He received the 1st dose of the Pfizer COVID vaccine on 4/22/21 and within 5 minutes, developed coughing, sneezing, and rhinorrhea. Within 2-3 hours, symptoms progressed into pt having swollen and red cheeks and red eyes. Denies any sob, tongue or lip swelling, hives, abd pain, dizziness. His BP was his normal, O2 was normal and he was sent home. He did not take any Benadryl or use epinephrine. That night he had subjective fever and night sweats. The symptoms lasted for 2 days and pt used Tylenol for symptomatic relief. Sx resolved by the 3rd day
27 2021-05-05 unresponsive to stimuli Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Fainting / Unres... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received vaccine, sat in observation chair for about 3 min speaking on his phone, patient leans forward and passes out, falling out of the chair and hitting the floor. The patient was unconscious for about 10-15secs. Pharmacist administering vaccine, immediately went to his aid and had his sit. I was called over and offered medical care, which he declined. Patient was given water and an ice pack for the abrasions received.
27 2021-05-07 pain in extremity Thought that I was in the clear of any side effects. First vaccine only resulted in a minor sore arm... Read more
Thought that I was in the clear of any side effects. First vaccine only resulted in a minor sore arm. Got second Phizer vaccine at 10:40 a.m. on 5/6 and went all day with nothing. Woke up at 2 a.m. the next morning (15.5 hours after vaccine) with sore arm at point of injection, chills, fever, aches, and a headache. Symptoms lasted all day. Woke up the next morning (46 hours after vaccine, 30 hours after symptoms started) with no lasting effects.
27 2021-05-08 pain in extremity Swelling and pain around arm, redness, sleepy
27 2021-05-09 migraine Migraine (2PM - 8PM) Fatigue (2PM - 8PM) Nausea (2PM - 8PM)
27 2021-05-09 seizure In the 15 minute waiting area patient begin to have seizure activity, then slumped into steering whe... Read more
In the 15 minute waiting area patient begin to have seizure activity, then slumped into steering wheel and then went rigid again with seizure like activity. Each one lasted approx. 15 -20 seconds. No medical hx of seizures per patients.
27 2021-05-10 feeling hot I received the first dose of the Pfizer vaccine. During the 15 minute evaluation, i felt nauseous, h... Read more
I received the first dose of the Pfizer vaccine. During the 15 minute evaluation, i felt nauseous, hot/sweaty and my vision got blurred to the point i passed out on the floor. After I regained conscio; I received the first dose of the Pfizer vaccine. During the 15 minute evaluation, i felt nauseous, hot/sweaty and my vision got blurred to the point i passed out on the floor. After I regained conscio; I received the first dose of the Pfizer vaccine. During the 15 minute evaluation, i felt nauseous, hot/sweaty and my vision got blurred to the point i passed out on the floor. After I regained conscio; I received the first dose of the Pfizer vaccine. During the 15 minute evaluation, i felt nauseous, hot/sweaty and my vision got blurred to the point i passed out on the floor. After I regained conscio; I received the first dose of the Pfizer vaccine. During the 15 minute evaluation, i felt nauseous, hot/sweaty and my vision got blurred to the point i passed out on the floor. After I regained conscio; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 10Apr2021 at 15:00 (Batch/Lot Number: EW0158) at 27-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 was reported as none. There were no concomitant medications received within the two weeks of vaccination. The patient experienced: "I received the first dose of the Pfizer vaccine. During the 15-minute evaluation, I felt nauseous, hot/sweaty and my vision got blurred to the point I passed out on the floor. After I regained consciousness (medically significant, hospitalization) on 10Apr2021 at 15:00. Reported Event: The patient received the first dose of the Pfizer vaccine. During the 15-minute evaluation, the patient felt nauseous, hot/sweaty and their vision got blurred to the point where the patient passed out on the floor. After, the patient regained consciousness with the assistance from the doctors and nurses there. The patient passed out again within minutes. After the second time, the patient was placed on a stretcher and sent to the emergency room for further testing. The patient reported that he had no history of medical conditions. The patient stated "all because of my vaccine hospitalization, I acquired a (some amount) medical bill. I would like to discuss assistance for handling this. I have all of the paperwork as proof. It's very unfortunate to pay this amount due a shot." Pfizer received an adverse event letter from withheld directed to Department, on 03May2021. Customer Verbatim: "On Saturday, 10April2021, I received the first dose of the Pfizer vaccine. During the 5-minute evaluation, I passed out on the floor. After I regained consciousness, I passed out again within minutes. After this, I was taken to the emergency room. I have no history of medical conditions. All because of my vaccine hospitalization, I acquired a (some amount) medical bill. I would like to discuss assistance for handling this. I have all of the paperwork as proof. " It was reported that the events required an emergency room visit and physician office visit. The patient was hospitalized due to the events from 10Apr2021 to an unknown date for 1 day (as reported). It was reported that no therapeutic measures were taken. The clinical outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
27 2021-05-10 feeling hot Starting 10 mins after vaccination, patient complains of blurry vision and feeling hot. Instructed t... Read more
Starting 10 mins after vaccination, patient complains of blurry vision and feeling hot. Instructed to turn on AC in car and patient reports he had not eaten much today. OJ given. At 15:15 episode of emesis x 1. Nausea relieved after emesis. Water given and vision returned back to baseline. Vitals 15:16 T975., HR 74, RR 16, O2 97% RA, BP 102/82. Patient remained at site for about 10 mins and symptoms entirely resolved.
27 2021-05-10 unresponsive to stimuli, grand mal seizure, seizure Patient appeared to have 45-60 second seizure following first dose of Pfizer COVID-19 vaccine. Appea... Read more
Patient appeared to have 45-60 second seizure following first dose of Pfizer COVID-19 vaccine. Appeared to experience a tonic/clonic seizure. He was sitting in a chair, scheduling an appointment to receive his second COVID-19 vaccine and became unresponsive and stiff. Staff responded, patient was lowered to the floor for safety. Patient was turned on his side to maintain airway. O2 was take 97-99% on RA. Once rigidity had resolved, O2 was applies at 3L NC as a precaution once stiffness resolved. BP was taken, 83/59 and pulse 105 side laying. 5 min later, BP 109/73, pulse 106 supine. EMS was called, patient transferred to ambulance. Patient was alert and oriented.
27 2021-05-12 speech disorder PT FAINTED AFTER VACCINATION. AFTER HE WOKE UP WE HE STILL SEEMED LETHARGIC AND WAS MUMBLING. HIS BP... Read more
PT FAINTED AFTER VACCINATION. AFTER HE WOKE UP WE HE STILL SEEMED LETHARGIC AND WAS MUMBLING. HIS BP WAS 68/40 SO WE CALLED EMS. WE PUT PT ON THE FLOOR AND RAISED HIS LEGS. EMS EVALUATED PT AND TRANSPORTED HIM TO HOSPITAL FOR FURTHER EVALUATION
27 2021-05-13 pain in extremity, feeling hot Body aches, headaches, chills, body very hot, lots of soreness in arm of injected site, arm ache on ... Read more
Body aches, headaches, chills, body very hot, lots of soreness in arm of injected site, arm ache on other arm after a day as well
27 2021-05-14 limb paralysis Began to have pain in hip that progressed to severe pain and parlaying leg and foot; Unable at 2 nd ... Read more
Began to have pain in hip that progressed to severe pain and parlaying leg and foot; Unable at 2 nd week to stand or walk; Unable at 2 nd week to stand or walk; Began to have pain in hip that progressed to severe pain and parlaying leg and foot; This is a spontaneous report from a contactable consumer (parent). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 30Apr2021 at 15:30 (at the age of 27 years) as unknown dose, single for COVID-19 immunization. Medical history included obesity and mental illness. Concomitant medications included aripiprazole (ABLIFY), sertraline hydrochloride (ZOLOFT), metformin, bupropion hydrochloride (WELLBUTRIN), simvastatin and 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 and since the vaccination, it was unknown if the patient was tested for COVID-19. The patient was hospitalized on 27Apr2021 for an unknown reason and began to have pain in hip that progressed to severe pain and parlaying leg and foot on 03May2021. Unable at the second week to stand or walk. These adverse events result in emergency room (ER) or department or urgent care. The patient's hospitalization was prolonged and the patient was disability as a result of these events. It was unknown if the treatment was received by the patient due to these events. It was reported that the duration of hospitalization was 10 days discharged on 07May2021 (also reported as continued, CLARIFICATION PENDING). The outcome of all these events was not recovered at the time of report. Information on the lot/batch number has been requested.
27 2021-05-14 muscle spasms High fever, chills, shorten breathe, dizziness, fatigue, muscle spasms, joint pain
27 2021-05-14 unresponsive to stimuli Patient was administered the Pfizer vaccine and was asked to wait around the pharmacy for 15 minutes... Read more
Patient was administered the Pfizer vaccine and was asked to wait around the pharmacy for 15 minutes post vaccination. After 5 minutes, patient started feeling dizzy and started to faint. He was accompanied by his parents, father tried waking patient up a few times but he was unresponsive to wake and started to tilt his head backwards and falling over. We called the paramedics and administered the epipen. Father did notify us that patient is fine and was discharged from the ER on the same day.
27 2021-05-15 cold sweat Chills, cold sweats, throbbing headache, and hives
27 2021-05-15 feeling hot Severe fever and chills overnight, unmeasured but body noticeably hot to touch. Fever still 99.8 dur... Read more
Severe fever and chills overnight, unmeasured but body noticeably hot to touch. Fever still 99.8 during next day after several hours when thermometer was acquired, but had significantly broken by that point
27 2021-05-17 involuntary muscle movements Pt DOB 1/4/1994. Pt had his first dose of Pfizer and was sitting in post observation. Per post obser... Read more
Pt DOB 1/4/1994. Pt had his first dose of Pfizer and was sitting in post observation. Per post observation staff to this writer: Pt began to jerk and slumped to his right side. Pt became diaphoretic, eyes were fixed but was able to answer all questions. Pt was laid onto cot feet elevated until Aid arrived. Guest reports he came from the gym and has not eaten today. Pt back to baseline and cleared to d/c home. Pt mother came to drive Pt home.
27 2021-05-17 numbness, pain in extremity fainted; lost consciousness for a couple of seconds; burning pain that felt like needles on his shou... Read more
fainted; lost consciousness for a couple of seconds; burning pain that felt like needles on his shoulder, left arm and a little on the right side/extremely, burning pains across his back/He had burning pain on his shoulders, very sensitive, felt like a 3rd degree burn; felt like he could not stand and had to go to the floor, struggled to get up; arms were numb; thought he was having a heart attack; left arm weak; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; left side of face is swollen; left side of face is swollen was reported as worsened.; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; left arm pain; This is a spontaneous report from contactable consumers (patient reported for himself, patient's mother). A 27-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 01May2021 12:00 noon (Batch/Lot Number: EW0170; Expiration Date: 31Aug2021) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunization, at the age at vaccination of 27 years old. The patient's medical history and concomitant medications were not reported. The patient experienced thought he was having a heart attack(medically significant) on 03May2021 01:00 with outcome of unknown, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (medically significant) on 03May2021 with outcome of not recovered, fainted (medically significant) on an unspecified date with outcome of unknown, lost consciousness for a couple of seconds (medically significant) on 03May2021 01:00 with outcome of recovered with sequelae on 03May2021, burning pain that felt like needles on his shoulder, left arm and a little on the right side/extremely, burning pains across his back/he had burning pain on his shoulders, very sensitive, felt like a 3rd degree burn (non-serious) on 03May2021 01:00 with outcome of unknown, felt like he could not stand and had to go to the floor, struggled to get up (non-serious) on 03May2021 01:00 with outcome of recovered with sequelae on 03May2021, arms were numb (non-serious) on 03May2021 01:00 with outcome of recovering, left arm pain (non-serious) on 03May2021 with outcome of not recovered, left arm weak (non-serious) on 03May2021 01:00 with outcome of unknown, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (non-serious) on 03May2021 01:00 with outcome of not recovered, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (non-serious) on 03May2021 with outcome of not recovered, left side of face is swollen (non-serious) on 03May2021 01:00 with outcome of not recovered , left side of face is swollen was reported as worsened (non-serious) on 03May2021 with outcome of not recovered. The patient underwent lab tests which included computerised tomogram (brain CT): no results, electrocardiogram (EKG): no results, both on unknown date. Reported patient was in pain and his mom and dad didn't know what to do. He had sharp pains. No bruises. He remember lowering myself to fall. He didn't fall. It was a strange thing. When he went to the ER they didn't fine anything. He was still in the same amount of pain. Caller stated her son took the vaccine on Saturday. Thirty six hours later around 1:00am he started getting extremely, burning pains across his back.The patient stated he was coming out of the bathroom and felt like he couldn't stand and he had to go to the floor. He lost consciousness for a couple of seconds. Both arms were numb. He struggled to get up. He sat on the couch and then went upstairs after being in the basement. He had a burning pain that felt like needles on his shoulder, left arm and a little on right side. His skin was sensitive. The back of his neck feels like he has a third degree burn. This morning he went to the hospital. Initially said he fainted but clarified that he was speaking about losing consciousness. He had left arm pain. He thought he was having a hard attack. While at the emergency room today he had labs, a brain CT scan and an EKG. He does not have results to provide. Caller added that his skin was hypersensitive. It was like if he moves the hair on his arm it hurts. His parents noticed he has swelling on the left side of his face. The events require a visit to Emergency Room. No Prior Vaccinations (within 4 weeks). Information on Lot/Batch number was available. Additional information has been requested.
27 2021-05-17 migraine dry cough, runny nose, migraine, dizziness, trouble sleeping, stiffness, weakness in left arm, sore ... Read more
dry cough, runny nose, migraine, dizziness, trouble sleeping, stiffness, weakness in left arm, sore throat,...
27 2021-05-17 unresponsive to stimuli Pt feeling lightheaded, BP 102/71; HR 79; RR 18. At assessment in observation pt hard to initiate a ... Read more
Pt feeling lightheaded, BP 102/71; HR 79; RR 18. At assessment in observation pt hard to initiate a response, blankly staring & unresponsive to questions. Eventually responded after 1 min & stated "I'm dizzy." Wheeled to bay, VS stable, AOx4, dizziness subsided per pt. Water given, BP 120/71 sitting, feels good to walk on own.
27 2021-05-19 tingling Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in both arms and fingers
27 2021-05-19 seizure Almost immediately after patient received the second dose of vaccine he stood up and passed out to t... Read more
Almost immediately after patient received the second dose of vaccine he stood up and passed out to the floor. He slightly seized for a few seconds until it stopped. When patient came to he stated that his knee hurt but he didnt believe he hit his head and he felt a bit light headed. Patient laid down for a while with us until he started to feel better. His BP was 102/58, but normally runs low. He said that he has passed out before and has been under a lot of stress, also had not eaten that morning before getting vaccinated. His significant other was with him and was planning to drive home. Patient was offered a call to EMS but refused.
27 2021-05-21 numbness, pain in extremity, tingling Initial symptom was tingling then loss of feeling in both lower legs. Happened a few times over seve... Read more
Initial symptom was tingling then loss of feeling in both lower legs. Happened a few times over several days. Lasted for several minutes each episode. Also had involuntary muscle tightness and pain in left upper thigh (quads) and left biceps. These episodes also happened several times, but not concurrently.
27 2021-05-22 bell's palsy Bell's Palsy on the right side of my face; muscle weakness around the right corner of my mouth, chee... Read more
Bell's Palsy on the right side of my face; muscle weakness around the right corner of my mouth, cheek, and eye.
27 2021-05-22 tremor, flushing, unresponsive to stimuli Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Letha... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild, Additional Details: Patient passed out about 5 minutes after receiving immunization. He came to fairly quickly but was confused, shaky and sweaty. After laying on the floor for a while he became nauseous but did not physically vomit while in my care. As the paramedics arrived the patient passed out a second time and was taken to the ER after evaluation.
27 2021-05-22 tremor, flushing, unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-M... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
27 2021-05-23 seizure Roughly 5 minutes after vaccine patient lost awareness, became red in the face, eyes rolled to back,... Read more
Roughly 5 minutes after vaccine patient lost awareness, became red in the face, eyes rolled to back, seizure like activity for about 1 to 2 minutes. 911 was called and the patient was assessed and released.
27 2021-05-24 discomfort Moderate aches experienced on the day following vaccination (5/23) beginning in the morning. Two dos... Read more
Moderate aches experienced on the day following vaccination (5/23) beginning in the morning. Two doses of ibuprofen taken in the morning and afternoon. Mild pain experienced in left front armpit, nearly on the left pectoral, on the night following vaccination. On the following morning (5/24), moderate swelling was noticed in the left armpit, extending from underneath the armpit down to the upper lat muscles and up along the left pectoral nearly to the nipple up to just below the left collarbone. Mild pain experienced in the left front armpit as well as on the lymph node under the armpit. No inhibition of arm motion or pain when using arm, but some feeling of discomfort and pressure. Tele-med help was sought which did not recommend any course of action. By the afternoon, moderate swelling was noticed on the left arm, on the bicep and tricep down to the elbow. Ibuprofen was taken at ~3pm with no effect. Medical advice was sought at 7pm and it was recommended to head to urgent care, but all providers in the area were closed. By this morning (5/25), the swelling has reduced significantly and localized to the left front armpit. Mild pain remains, now more localized to the lymph node under the left armpit.
27 2021-05-25 pain in extremity 27-year-old gentleman with history of mild intermittent asthma, anxiety, presented with complaints o... Read more
27-year-old gentleman with history of mild intermittent asthma, anxiety, presented with complaints of fever of 99.8 °F on 5/22/2021 associated to fatigue and body aches and then chest pain, generalized with radiation to left arm since afternoon of 5/23/2021, which got worse on 5/24/2021 and he was admitted for further evaluation with initial troponin of 472. Had an NSTEMI; chest tightness, pain in left arm, lightheadedness, dizziness, presyncope. Discharge diagnosis - probable myocarditis; clinical picture most consistent with viral myocarditis.
27 2021-05-25 pain in extremity Very sore arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 27-year... Read more
Very sore arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm right, on 19Feb2021 at 08:30 AM (Lot Number: EN6203), as single dose, for COVID-19 immunisation. The patient's medical history was none. Patient had no known allergies. Patient did not have COVID-19 prior to vaccination. Concomitant medications included loratadine (unknown manufacturer), vitamin d3 (unknown manufacturer) and men multivitamin 1x/day. The patient experienced very sore arm (non-serious) in Feb2021 at 12:00 PM with outcome of unknown and nausea (non-serious) in Feb2021 at 12:00 PM with outcome of unknown. Patient has not been tested for COVID-19 post vaccination. Follow-up attempts are completed. No further information is expected.
27 2021-05-25 cold extremities Patient started to feel dizzy , skin color getting pale , cold hands , sweat , and was about to f... Read more
Patient started to feel dizzy , skin color getting pale , cold hands , sweat , and was about to faint 5 minutes after administering the vaccine . pharmacist on duty grabbed the Epipen and blood pressure machine . patient blood pressure was 65/40 , patient started to feel better for couple minutes then he start to feel dizzy and to get same symptoms again , at this moment pharmacist injected the patient with Epipen as he stated he iwas fainting .patient denied to have any allergies , fear for needles or any health conditions . pharmacist kept watching and monitoring the patient till his blood pressure came back to 118/69. patient family came to pick him up .
27 2021-05-25 sciatica, nerve pain Flared up my chronic lower back pain, which flared up my nerve/sciatic pain. At its worse, it was so... Read more
Flared up my chronic lower back pain, which flared up my nerve/sciatic pain. At its worse, it was so bad I couldn?t walk.
27 2021-05-26 seizure Employee have a history of a seizure disorder received vaccine 1030 seizure started at 1047
27 2021-05-27 feeling hot Pfizer was given as second dose of which patient received moderna for the first one. Patient experi... Read more
Pfizer was given as second dose of which patient received moderna for the first one. Patient experienced a warm feeling in the arm. It continued but by the afternoon 3 o'clock he was feeling better
27 2021-05-27 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Se... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Medium
27 2021-05-27 numbness, tingling After first Pfizer dose, I was just feeling really tired. After the second dose, around that afterno... Read more
After first Pfizer dose, I was just feeling really tired. After the second dose, around that afternoon/evening I started feeling my mouth feeling weird. The next day I saw blisters filled with yellow/whiteish puss in my tongue. I went to the ER later i felt a lump under left shoulder while showering. On 28 MAY 3 AM I suddenly felt my face feeling numb and tingly along with my legs. Mind you I have been in the field emplacing howizters for the past few days in a field exercise. I also jammed my finger on an 80 lb metal bar on 26 MAY and got my finger poked with a hot device that also drained the blood after getting an xray. I called medical ER at 242 and spoke to Dr.(?) Doctor did not give me his name spelling after I asked for the spelling and he told me that I could always come in to the ER. I told him whether the finger pricking and blooding draining could cause the left facial numbness and legs tingleness. He said no so i am now assuming it is an adverse side effect. I am a smart guy have bachelors in journalism but right now I cannot concentrate and filling out htis form hastily just i case the effects get worse and I have to go to hospital er. Talking to the Dr. (?) was harder than normal and he asked if my breathing was normal, I said i am breathing heavily, which I did not have much control over. He said breathe normally and I will be better from the tingliness. I can write well I am a journalism major but this is hard to write for me . I am also feeling chills and I am also not feeling well. I was able to get this link from my local online meeting and I am glad I can contribute to the research and science in general. I wish the doctor had tested me for possible problems when I had an adverse effect from the first vaccine but the doctor told me to come back if the "viral infection" gets worse after I breathe normal. I did take a PT test and my 2 mile run time increased and it was much harder to run than the 2 mile run. Time went up by at least 3 minutes.
27 2021-05-28 weakness Swollen lips; Swollen tongue; Swollen face; Itchy throat; Lightheaded; weak; feeling Sore on right a... Read more
Swollen lips; Swollen tongue; Swollen face; Itchy throat; Lightheaded; weak; feeling Sore on right arm; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: EN 6204) via an unspecified route of administration in right arm on 12Mar2021 at 08:45 AM (at the age of 27-years) as a single dose for COVID-19 immunization. Medical history included allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. On 12Mar2021, post the vaccination, the patient felt soreness on the right arm. On 13Mar2021 at 12.00 PM, he started to become very weak, and light headed. On 14Mar2021, he woke up and his entire face was swollen including his tongue and his throat was itchy and on 17Mar2021, his lips and tongue were still swollen. Therapeutic measures included treatment with methylprednisolone acetate (DEPO-MEDROL) 40 mg/ml injection. The clinical outcome of the events vaccination site pain, weakness, light headedness, swollen face, swollen tongue, swollen lips, and itchy throat was reported as not resolved. No follow-up attempts are needed. No further information is expected.
27 2021-06-01 numbness felt numb and emotionless; felt numb and emotionless; felt sick to my stomach; Food does not take go... Read more
felt numb and emotionless; felt numb and emotionless; felt sick to my stomach; Food does not take good anymore and I have to force myself to eat; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 11May2021 16:30 (Batch/Lot Number: EW0173) (at the age of 27-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included known allergies nickel. Concomitant medications included none (did not receive other medications the patient received within 2 weeks of vaccination). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 administered in Arm Right on 20Apr2021 17:30 (Batch/Lot Number: EW0170) for covid-19 immunisation and had no adverse event. 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 12May2021 09:30, the patient experienced felt numb and emotionless, felt sick to my stomach and food does not take good anymore and i have to force myself to eat. Seriousness criteria reported as non-serious. No treatment was given for the events. The outcome of the events was not recovered.
27 2021-06-05 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: PAIENT GOT PANIC ATTACK AND FAINT BUT ... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: PAIENT GOT PANIC ATTACK AND FAINT BUT RECOVER WITH IN 3-4 M INUTES, CALLED 911, PARAMEDIC HELPED HIM
27 2021-06-08 pain in extremity I CALLED THIS PATIENT AND HE SAID HE FELT NAUSEOUS LAST NIGHT. HE SAID IT MAY HAVE BEEN DUE TO WHAT ... Read more
I CALLED THIS PATIENT AND HE SAID HE FELT NAUSEOUS LAST NIGHT. HE SAID IT MAY HAVE BEEN DUE TO WHAT HE ATE. BUT OTHER THAN THAT, JUST A SORE ARM TODAY.
27 2021-06-09 night sweats Headache; Fever; Chills; Sweating all night; This is a spontaneous report received from a contactabl... Read more
Headache; Fever; Chills; Sweating all night; This is a spontaneous report received from a contactable consumer (patient's parent). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202), on 04Mar2021 (at the age of 27-year-old) as unknown, single dose for COVID-19 immunisation. Vaccine facility type was reported as workplace clinic. The patient's medical history included known allergies: seasonal allergies, mold, dust, and mites. No COVID prior vaccination was reported. No concomitant medications in two weeks were reported. Patient did not receive other vaccines in four weeks. On 05Mar2021 the patient had headache, fever, chills and sweating all night. Patient was treated due to the events with paracetamol (TYLENOL). Patient was not tested for COVID post vaccination. The outcome of the events was recovered with sequel (reported as recovered with lasting effect). No follow-up attempts are needed. No further information is expected.
27 2021-06-09 seizure The patient was given Pfizer Covid vaccine and was the 1st dose in series. The patient walked to obs... Read more
The patient was given Pfizer Covid vaccine and was the 1st dose in series. The patient walked to observation chair after receiving vaccine. He fell from chair to the floor and appeared to have a seizure with arm movements and became aware soon after. Ems was called. Patient had some water and disclosed that he had not eaten yet. He then had OJ while awaiting EMS. He did not go with EMS.
27 2021-06-10 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
27 2021-06-12 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient was sitting in chair and rested head on arms. Then he fell out of chair onto floor. Immediately woke up after rph-on-duty went to him. He sat on floor for approximately 3 minutes and then was feeling well enough to sit in chair. Patient was able to communicate and sit in chair again. Patient stayed at pharmacy for approximately 30 minutes and was well enough to walk on own. No other issues reported by patient.
27 2021-06-13 numbness, feeling cold 3:00- 2nd dose Pfizer covid-19 vaccine placed to left arm. 3:05- reports ?saw shooting stars? pt pal... Read more
3:00- 2nd dose Pfizer covid-19 vaccine placed to left arm. 3:05- reports ?saw shooting stars? pt pale, laid him down immediately BP 122/82, HR 62, 100% on RA. 3:15 Pt reports facial numbness in lower face. Reports numbness to left arm. Pt report he feels cold. +Nausea. Brief neuro exam, equal facial symmetry, equal grips, Eye tracking normally, speech clear, normal and equal strength in all extremities. 145/80, HR 100 sat 100%. 3:28 Numbness to left arm resolved. Numbness to cheeks and lips continues. Nausea persisting. Pale. Pt reports he felt lower facial numbness 4 hours after first dose of Pfizer covid-19 vaccine, he did not seek medical care and reports the symptoms resolved. Pt in seated position, Pt given juice, tolerating well. BP 122/75, HR 104 98% on RA. 3:43 + emesis, HR 95-105, 98% on RA. PT states he feel better after episode of emesis. States lower facial numbness improving. PT pale. PT states he feels well enough to leave. Pt encouraged to stay to be monitored. Pt reports that his daily food intake consisted of 1 breakfast Danish during the morning, did not eat during the day. Pt reports he smokes 1 pack of cigarettes per day. 3:50- Pt given small sips of water and crackers. Pt tolerating well. Pt no loner pale. Pt denies facial numbness, Vitals WNL. 3:59-Ambulation trial with PT and Nurse. Pt tolerating well. 4:15- Pt Alert and oriented. Pt expressed that he feels well and would like to leave. PT edu given to contact PCP. Pt advised to contact EMS or ER if symptoms return or if new symptoms arise. PT aware of risks. Pt escorted to Car by staff.
27 2021-06-13 tremor, cold sweat cold skin, headaches, dizzy, throwing up blood, shaking, heart rate was elevated, hard time breathin... Read more
cold skin, headaches, dizzy, throwing up blood, shaking, heart rate was elevated, hard time breathing
27 2021-06-16 tingling Pt c/o Left hand/finger tingling 15min after receiving his first dose. BP 130/76, HR 63, RR 16, 98%... Read more
Pt c/o Left hand/finger tingling 15min after receiving his first dose. BP 130/76, HR 63, RR 16, 98% on RA. Pt mentating well and speaks in full sentences. No CP, SOB, DIB, N/V. NP monitored pt and pt stated that his condition is improving. Pt stated that he was on his computer all day. Possible carpal tunnel. Wrist brace encouraged. Stop repetitive movements until tingling subsides. Pt stable and released from vaccination site. Recommended that the pt follow up with their healthcare provider, follow up instructions provided.
27 2021-06-17 facial paralysis, bell's palsy Bell?s Palsy Paralysis and swelling on the left side of the face Prednisone for treatment
27 2021-06-17 pain in extremity Around 2 weeks after my first dose, I started having heart palpitations. The palpitations were on an... Read more
Around 2 weeks after my first dose, I started having heart palpitations. The palpitations were on and off for a week and I didn't think of it much. A week after the palpitations started it started happening more frequently and I was feeling light headed and I went to ER. I was diagnosed with SVT and put on metoprolol to control my heart rate. 1 week after I was on metoprolol, I took my second dose. I was feeling a little dizzy after my second dose but it improved after like 10 minutes. I started getting very fatigued and difficult to concentrate after my second dose. I spoke to my doctor and we thought it was because of metoprolol. My cardiologist took me off metoprolol but the fatigue didn't stop and I started having aches in shoulders, arms, neck and back. The aches and fatigue was more severe in the morning. After a week of being off metoprolol I started waking up with chest pain. One day the pain was severe and I had aches in shoulders, arms, neck and back and my heart rate was around 140 so I went to ER. The doctors put me on carvedilol and my heart rate has been controlled but my body aches and fatigue has been going on. The cardiologist and my PCP aren't sure if SVT or the medication is causing my body aches and fatigue. The only other thing I could think of was the vaccine so I wanted to send this report.
27 2021-06-18 pain in extremity Headache; diarrhea; chills; sweating; sore arm; This is a spontaneous report from a contactable cons... Read more
Headache; diarrhea; chills; sweating; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: unknown), via an unspecified route of administration, in his left arm on 17Mar2021 (at the age of 27-years-old) for COVID-19 immunisation. The patient had no medical history and had no known allergies. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The concomitant medications included cephalexin (MANUFACTURER UNKNOWN) for an unknown indication. On 18Mar2021 at 03:15 am, the patient experienced headache, diarrhea, chills, sweating and sore arm. No therapeutic measures were taken for these events. The clinical outcome of the events headache, diarrhea, chills, sweating and sore arm was unknown at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
27 2021-06-20 tension headache 27 yo M presents to the ICC c/o a headache and dizziness. States that he has neck muscle stiffness a... Read more
27 yo M presents to the ICC c/o a headache and dizziness. States that he has neck muscle stiffness and a squeezing, pressure-type headache that is affecting the top of his head and both sides of his forehead. The lights are bothering him and he is nauseated. Received COVID vaccination 4 days ago. Had a headache yesterday, which was worse than the one he has today. Has not taken any medications for symptom relief because he did not want to mess with the vaccine. Symptom duration == 5 hours. Not worsening. Diagnosed with a tension headache. Treated with acetaminophen 1000 mg. Rated 8-9/10 before taking acetaminophen and 3-4/10 after acetaminophen.
27 2021-06-24 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
27 2021-06-27 hot flush I am experiencing hot flashes, cold shivers, fever, full-body muscle soreness, headache, and vomitin... Read more
I am experiencing hot flashes, cold shivers, fever, full-body muscle soreness, headache, and vomiting. Vomiting only happened once during a really bad hot flash. Onset of event was roughly 12 hours after receiving second dose, and has continued through for almost 48+ hours on and off.
27 2021-06-30 feeling hot, pain in extremity Headache; injection site is at hurts a little bit.; he is feeling warm, is not sure if it's due to t... Read more
Headache; injection site is at hurts a little bit.; he is feeling warm, is not sure if it's due to the vaccine and he thought he might want us to know; arm hurts; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 27-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 22Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient experienced headache, injection site is at hurts a little bit, he is feeling warm, is not sure if it's due to the vaccine and he thought he might want us to know and arm hurts on an unspecified date in 2021. Patient asked if it's alright to take Aspirin or place an ice pack on the injection site. Outcome of all the events was unknown. Information about Lot/batch number is requested.
27 2021-07-05 tremor temporary loss of vision; sweating; pale skin; shacking; This is a spontaneous report from a non-con... Read more
temporary loss of vision; sweating; pale skin; shacking; This is a spontaneous report from a non-contactable pharmacist. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown), intramuscularly, administered in left deltoid on 20Jun2021 15:00 (at 27-year-old) as dose 1, single, for COVID-19 immunization. The patient had no medical history. No unknown allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cannabis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jun2021 at 15:00, the patient experienced temporary loss of vision, sweating, pale skin, and shacking. The events resulted in emergency room/department or urgent care. It was unknown whether treatment was received. The outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: Based on the temporal relation, the association between the event blindness and vaccination cannot be completely ruled out. 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 2021-07-07 discomfort Starting on Wednesday morning, couldn't hear in left ear and over the day both ears starting to lose... Read more
Starting on Wednesday morning, couldn't hear in left ear and over the day both ears starting to lose hearing. Thursday both ears felt like they were clogged and continued to get worse and felt pain and have a fever up until today. Patient also experienced ringing in the ear and discomfort. Pt would not use phone. Also experience dizziness. Patient was seen at urgent care on 7/7/21 and was diagnosed as a double ear infection and was prescribed cefdinir.
27 2021-07-07 seizure Observation RN noted a "30 second seizure" less than 15 minutes post vaccination. Initial steps tak... Read more
Observation RN noted a "30 second seizure" less than 15 minutes post vaccination. Initial steps taken by staff on duty, including calling EMS, which arrived shortly. Pt transported to local ED. Pt's SO states this has happened a few times previously associated with blood or needles. Pt was in a drive-thru vaccination/observation facility without AC on a nearly 100 degree day.
27 2021-07-08 weakness Within less than 5 min after administration, the patient looked pale, temporary lost of vision, and... Read more
Within less than 5 min after administration, the patient looked pale, temporary lost of vision, and weak to sit up straight. After asking more questions about his health and mediations, he informed about taking cannabis before the vaccination. By the paramedics came, he looked better and his vision came back. He was communicating and able to walk around.
27 2021-07-08 migraine Long lasting headache, migraine, vertigo, nauseous, unable to concentrate, brain fog, insomnia, stif... Read more
Long lasting headache, migraine, vertigo, nauseous, unable to concentrate, brain fog, insomnia, stiff neck, head sinus. Has been ongoing for 2 weeks
27 2021-07-08 tingling, pain in extremity About 4 hours post injection ring finger nerves became painful at tip with pins and needles feeling.... Read more
About 4 hours post injection ring finger nerves became painful at tip with pins and needles feeling. Still present, but not as painful. About 1 week post injection, began getting chest pains, difficulty breathing, and dizziness/lightheadedness. We to urgent care 1 week after symptoms started to appear as they got worse. EKG ran showing potential heart attach in past, but I don't think I've had one before. Was noted and told might have been due to crutches. Symptoms got worse next day so went to urgent care at different facility. Brought to ER for x-ray, blood , and EKG. Told no myocarditis, but potentially pericarditis.
27 2021-07-12 pain in extremity Very brief period of nausea; Slight drowsiness lingering; Soreness in arm on side that received inje... Read more
Very brief period of nausea; Slight drowsiness lingering; Soreness in arm on side that received injection; Soreness in shoulder; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male 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 28Mar2021 at 12:00 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included men daily multivitamin (MANUFACTURER UNKNOWN) and daily fiber supplement (MANUFACTURER UNKNOWN); both taken for unknown indication from unknown date. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 12:15, the patient experienced very brief period of nausea, some slight drowsiness lingering to about 2-3 hours after injection and soreness in shoulder/arm on side that received injection which lasted till approximately 21 hours. 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 the events nausea, drowsiness pain in arm and shoulder pain was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
27 2021-07-14 bell's palsy I got Bell?s Palsy, 2 weeks after I received the shot.
27 2021-07-17 night sweats Fever; Chills; Night sweats; This is a spontaneous report from a contactable other healthcare profes... Read more
Fever; Chills; Night sweats; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year-old male 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 15Mar2021 at 13:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. 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 22Feb2021 at 13:30 (at the age of 27-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 had not been tested for COVID-19. The patient had no known allergies to medications, food or other products. On 16Mar2021 at 00:00 the patient experienced fevers, chills and night sweats for two days. 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 treatment for the reported events. The clinical outcome of the fever, chills and night sweats was recovered on 18Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
27 2021-07-17 pain in extremity sore left arm; also had diarrhea from Saturday to Tuesday and my stool was bright yellow.; This is a... Read more
sore left arm; also had diarrhea from Saturday to Tuesday and my stool was bright yellow.; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route of administration in the left arm on 13Mar2021 (at the age of 27-year-old) at 15:00 as a single dose for COVID-19 immunization. Medical history included asthma and COVID-19. The patient had no known allergies. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 21:00, the patient experienced a sore left arm, diarrhoea from Saturday to Tuesday and his stool was bright yellow, which was not too serious. 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 adverse events. The clinical outcome of sore left arm was recovered on 15Mar2021, while that of diarrhoea was recovered on 16Mar2021 at the time of this report. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Prior to vaccination, was the patient diagnosed with COVID-19? Yes, added as Relevant Med History and vaccination Facility Country added.
27 2021-07-18 limb paralysis Within a few minutes of receiving the Pfizer Covid vaccine the patient passed out. He fell to the fl... Read more
Within a few minutes of receiving the Pfizer Covid vaccine the patient passed out. He fell to the floor. Person standing near said it looked like he hit his head on the sign he was next to but when he came to said his head did not hurt just his back and his arm which appeared to have carpet burn/scratch. He said he did not remember passing out only feeling nauseous. After a few more minutes he passed out once more. Firefighter checked vitals and said they were all fine. Patient declined transfer to a medical facility but did have someone come to pick him up. It was recommended to him to be checked at a medical facility but it is unknown if he did.
27 2021-07-20 tingling, numbness About one week after the second dose, I started to experience a persistent numbness throughout my le... Read more
About one week after the second dose, I started to experience a persistent numbness throughout my left arm. It is a "pins and needles" like feeling, mostly occurring in the left hand. However, if I use my arm for strenuous activity or let it sit the wrong way, the numbness persists in my arm as well. Soft and light movements generally ease the feeling, however it is not fully going away.
27 2021-07-21 pain in extremity Heart inflammation, fever, headache, arm ache, chest pain, shortness of breath, pulsing pain through... Read more
Heart inflammation, fever, headache, arm ache, chest pain, shortness of breath, pulsing pain throughout body, extreme pain at injection site, injection site was very hot to the touch, redness at injection site, swelling at injection site
27 2021-07-24 unresponsive to stimuli after giving imz., i went over adverse effects then after total of a few minutes i went to catch ph... Read more
after giving imz., i went over adverse effects then after total of a few minutes i went to catch phone and counsel. patient was fine in room. my assistant(who is a retired nurse) walked by and said patient was slumped and pale. i went into room immediately patient was fainting. eyes fluttered and closed still breathing. no response from voice or slight shaking. we put patients legs on other chair to elevate, (patient too heavy to move) He revived after a few minutes and we had him lay on ground with legs elevated. bp was 116/61 and he had eaten only a cliff bar after working the night shift. I gave him glucose. after 15 minutes or so he felt fine and called his sister to pick him up, while waiting i gave him pop tarts and cold water (his stomach was growling). He left with his sister and will return in 21 days for 2nd shot. I will call and check on him 24-48 hours from now.
27 2021-07-25 numbness and pain in extremities Neuropathy started in both feet and have radiated up towards knee. Started end of May, still ongoing... Read more
Neuropathy started in both feet and have radiated up towards knee. Started end of May, still ongoing. Also headaches, fatigue, dizziness.
27 2021-07-28 bell's palsy I got Bell's Palsy.; dose 1 on 27Apr2021, dose 2 on 27Apr2021; This is a spontaneous report from a ... Read more
I got Bell's Palsy.; dose 1 on 27Apr2021, dose 2 on 27Apr2021; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 27 year old male patient (age at vaccination 27 years old) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EW0171) as dose 1, single dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EW0185) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies. The patient was no prior to vaccination, was the patient diagnosed with COVID-19 and the patient not had the patient been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient experienced Bell's palsy, on 02Jun2021. The outcome of the event was not recovered. Upon follow-up on 22Jul2021 the follow-up attempts are completed. No further information is expected.
27 2021-07-28 numbness Within the first 5 minutes of injection: heart palpitations, shortness of breath, dizziness, extreme... Read more
Within the first 5 minutes of injection: heart palpitations, shortness of breath, dizziness, extreme thirst, and facial numbness.
27 2021-07-28 numbness Numbing and dead arm feeling; arm discomfort; This is a spontaneous report from a contactable consum... Read more
Numbing and dead arm feeling; arm discomfort; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on an unknown date in Mar2021 at 18:00 (at the age of 27-year-old) and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 26Mar2021 at 18:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. Prior to the 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 vaccination. On an unknown date in Mar2021 the patient experienced some numbing and discomfort around just the upper left arm area after the first shot, but not nearly as significant as the second shot, and it never came back like it was now (at the time of this report). After receiving the second dose, on 26Mar2021 at 18:00, the patient experienced numbing and dead arm feeling in upper left arm, extending into the armpit area and side of upper left chest area immediately, it went away after 1-2 hours and dead arm/discomfort returned 8-11 days later. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 22Mar2021, the patient underwent COVID-19 PCR test (nasal swab) and the result was negative. No therapeutic measures were taken as a result of the events. The clinical outcome of the event numbing and dead arm feeling and arm discomfort was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
28 2021-01-03 burning sensation Woke up to a burning sensation all over my face that quickly spread to my upper torso. I stumbled in... Read more
Woke up to a burning sensation all over my face that quickly spread to my upper torso. I stumbled into the bathroom and removed my pajama shirt to relieve the heat I was experiencing. I ran my hands under luke warm water and the sensation suddenly disappeared as quickly as it came. Later that same day I experienced fatigue and loss of appetite that lasted about 24 hours.
28 2021-01-04 tingling, flushing Pt. states that he received covid Pzifzer vaccine at 11:17 am on 01/05/2021 to left deltoid IM. Arou... Read more
Pt. states that he received covid Pzifzer vaccine at 11:17 am on 01/05/2021 to left deltoid IM. Around six to seven minutes at 11:23 am post vaccination patient started having burning sensation at site, felt flushed, diaphoretic, light-headed, nauseated, and now he is experiencing tingling to bilateral feet. Pt. states that earlier post vaccination he was feeling anxious, but he is no longer feeling anxious. Pt. denies feeling this way post vaccination with other vaccines. Pt. states that he is still having bilateral feet tingling up to both calves right greater than left.
28 2021-01-05 pain in extremity Arm pain, muscle aches, headache, chills. Started with arm pain a 6 hours after shot. Developed rest... Read more
Arm pain, muscle aches, headache, chills. Started with arm pain a 6 hours after shot. Developed rest of symptoms overnight.
28 2021-01-05 pain in extremity Patient returned about 2 hours after receiving vaccine complaining of chest tightness, shortness of ... Read more
Patient returned about 2 hours after receiving vaccine complaining of chest tightness, shortness of breath and arm and chest pain. Patient declined rapidly and could not breath. Called 911 and administered 1 dose of Epipen 0.3mg. Patient's breathing improved immediately. Patient went to ER for further workup.
28 2021-01-06 night sweats Fever and myalgias started approximately 36hrs after administration. Fever, myalgias, headache, dren... Read more
Fever and myalgias started approximately 36hrs after administration. Fever, myalgias, headache, drenching night sweats continued for over 24hrs until approximately 72hrs post administration.
28 2021-01-07 pain in extremity Congestion; Nostrils are really like dry inside; back was hurting; Body ache; Muscle ache; Sweats; B... Read more
Congestion; Nostrils are really like dry inside; back was hurting; Body ache; Muscle ache; Sweats; Body fatigue; Sore in arm; This is a spontaneous report from a contactable nurse. A 28-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included antidepressant therapy. Concomitant medication included sertraline hydrochloride (ZOLOFT) as an antidepressant therapy. On 28Dec2020, patient was sore in her arm. On 29Dec2020, the next day patient woke up, she had body fatigue and muscle aches and had the sweats and was fine the next day. On 30Dec2020, Wednesday, the patient's back was hurting and has a body ache. And on 01Jan2021, patient stated she was like super congested. There was no back ache or anything but just has a really bad congestion and stated her nostrils were like really dry inside. Therapeutic measures were taken as a result of congestion, nostrils were like dry inside with spray nose with normal saline and the use of a humidifier. The patient recovered from the event, back pain; has not recovered from the events, congested and nostrils were like really dry; and outcome of all other events was unknown.
28 2021-01-10 hot flush Awakened 4 times shivering, Headache- relieved with 1 gram of Tylenol. dizziness- resolved 3-4 hour... Read more
Awakened 4 times shivering, Headache- relieved with 1 gram of Tylenol. dizziness- resolved 3-4 hours after waking. Fatigue- slept for 13 hours after working Body aches (mainly lower extremities)- worsened above movement. Dull ache while at rest. resolved with time. Hot flashes- random hot flash with sweating. Still experiencing almost 48 hours after immunization.
28 2021-01-11 feeling hot Patient was feeling hot and appeared to be diaphoretic Pulse was 68 BPM, Respirations 12/minute Oxyg... Read more
Patient was feeling hot and appeared to be diaphoretic Pulse was 68 BPM, Respirations 12/minute Oxygen saturation 98% room air No c/o SOB and no difficulties breathing or swallowing Was given 250ml Orange juice and 200ml Water then another 150ml of soya milk within a one hour period Patient monitored closely with oversight by ARNP Patient felt improved and able to leave area approximately 2 hours later and was access last by ARNP
28 2021-01-11 night sweats Fever/chills/night sweats for 1 day, body aches, injection site pain, nausea for 3 days, headache fo... Read more
Fever/chills/night sweats for 1 day, body aches, injection site pain, nausea for 3 days, headache for 3 days, all resolved. Two doses of 1000 mg acetaminophen needed to resolve fever.
28 2021-01-12 cold sweat, tingling Patient asked to remain in observation area x15 minutes. Approximately 5 min into observation compl... Read more
Patient asked to remain in observation area x15 minutes. Approximately 5 min into observation complained of dizziness, tingling in fingers, sweating. Pulse 110, skin clammy. Requested patient move from chair to floor, remove jacket, instructed purse-lipped breathing, drank 2 bottles of water patient compliant and tolerated well. Pulse reduced to 79 at 1309, finger tingling resolved, asked patient to wait until 1:30 to leave, pt agreed. Symptoms resolved quickly and completely.
28 2021-01-13 tremor Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Minor Ras... Read more
Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Minor Rash/Itching/Shakiness on left side, followed by trouble breathing; symptoms lasted 1 day
28 2021-01-13 unresponsive to stimuli On day due for 2nd dose, Patient was found unresponsive at work in the hospital. Patient pupils wer... Read more
On day due for 2nd dose, Patient was found unresponsive at work in the hospital. Patient pupils were fixed and dilated. Full ACLS was initiated for 55 minutes with multiple rounds of bicarb, calcium chloride, magnesium, and epinephrine. Patient was intubated. Patient continued into V. Fib arrest and was shocked multiple times.
28 2021-01-14 weakness, numbness, migraine, pain in extremity Symptoms of 2nd Covid vaccine lot EL 1284: numbness in feet, legs throbbing, muscle weakness in legs... Read more
Symptoms of 2nd Covid vaccine lot EL 1284: numbness in feet, legs throbbing, muscle weakness in legs, overall tiredness I received my second Pfizer vaccine on 1/12/21 at 12:15 pm. After several hours, I felt weak and tired. By 7:00 pm, I had a migraine that wouldn?t go away and I had muscle ache in my feet and legs. On 1/13/21 I felt some numbness in my feet and my legs were throbbing. By 10:00 pm, both of my feet were completely numb and my legs were throbbing/radiating heat. It felt as if circulation was cut off from my feet entirely. On 1/14/21 I went into work where I?m constantly on my feet. I felt intense muscle weakness in my legs and thighs to point where I could barely stand up. I immediately went to an urgent care where they started me on an Sodium Chloride 0.9% intravenous IV solution drip. They ran blood tests and urine tests to rule out any other causes to my symptoms. All results came back negative. I was told to rest, hydrate, and recover for the next several days. If my symptoms did not subside within the next couple days, I was instructed to go to the ER for further examination.
28 2021-01-19 tingling postural dizziness; dyspnea; paresthesia; This is a spontaneous report from a contactable Physician.... Read more
postural dizziness; dyspnea; paresthesia; This is a spontaneous report from a contactable Physician. This Physician reported for a 28-year-old male patient received 2nd dose of BNT162B2 Intramuscular on 10Jan2021 07:30 on Left arm for covid-19 immunization. Medical history and concomitant drug were not reported. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Historical Vaccine was first dose of BNT162B2 on an unspecific date. Patient experienced Moderate reaction: postural dizziness, dyspnea, and paresthesia on 10Jan2021 09:00 AM that resolved with H1 and H2 antagonists and IV hydration. AE-resulted-in Emergency room/department or urgent care. Outcome of the event was recovered. No covid-prior-vaccination. 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 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.
28 2021-01-20 pain in extremity, weakness strong pulsating heartbeat; severe arm pain; fever with temperature of 102 [units unspecified]; abdo... Read more
strong pulsating heartbeat; severe arm pain; fever with temperature of 102 [units unspecified]; abdominal pain; general weakness; unquenchable thirst; very bad headache; tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 10Jan2021 10:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he did not experience any symptoms yesterday (unspecified date) and a few hours ago, he started to experience severe arm pain, fever with of 102 [units unspecified], abdominal pain, general weakness, unquenchable thirst, very bad headache, tiredness and strong pulsating heartbeat. The outcome of the events was unknown. Information about lot/batch has been requested.
28 2021-01-21 migraine, hot flush Migraine began at 01:00pm following hot flashes, diarrhea, vomiting and nausea at about 2:30pm. Migr... Read more
Migraine began at 01:00pm following hot flashes, diarrhea, vomiting and nausea at about 2:30pm. Migraine became more pronounce when under light. Sweating began at 8:30pm when I notified charge nurse of side effects and requested to leave. I?ve taken 500mg of Tylenol at 1:00pm which helped until 3:00pm when I took 500mg again which lasted until 11:00pm when effects of medicine started to wear off.
28 2021-01-21 tingling Tenderness at injection site lasting ~36 hours Noted weakness and loss in dexterity in hand Feeling ... Read more
Tenderness at injection site lasting ~36 hours Noted weakness and loss in dexterity in hand Feeling of swelling in hand Pins and needles sensation in full arm and extending through fingers
28 2021-01-24 discomfort, feeling hot 1st shot of Pfizer-BioNTech: 12/29/2020, left shoulder: marginal shoulder pain from 12/29 to 12/31, ... Read more
1st shot of Pfizer-BioNTech: 12/29/2020, left shoulder: marginal shoulder pain from 12/29 to 12/31, no further swellings (ek9231) 2nd shot of Pfizer-BioNTech: 01/22/2020, also left shoulder (el3247): less shoulder pain throughout; feeling that it "spreads" from injection side to left side of the neck in the following hour; on the 01/24 in the morning, palpable swollen lymph node with accompanying calor and dolor right on top of the left clavicular bone; 01/25 swelling reduced, calor and dolor mostly gone but lymph node still palpable No additional drugs taken and on a scale of 0 to 10 maybe a 2/10 causing discomfort
28 2021-01-28 feeling hot tired; dizzy/dizziness/lightheaded; chills; he is warm all of a sudden; a history of vertigo, so he ... Read more
tired; dizzy/dizziness/lightheaded; chills; he is warm all of a sudden; a history of vertigo, so he thought he was having a vertigo attack; super sick on the 8th after his second dose; Fever; This is a spontaneous report from a contactable nurse (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration on 07Jan2021 at single dose on the left arm for COVID-19 immunization. Medical history included vertigo from Aug2019. There were no concomitant medications. The patient received the vaccine through the facility where he works (not a military facility). Patient received his first dose on 17Dec2020 (lot number: EL0140). Patient said that the symptoms started Monday, he was super sick Friday after first dose. Patient clarified to super sick on 08Jan2021 after his second dose. On 08Jan2021 after his second dose, patient had a fever of unknown temperature which he slept through it. He was tired the whole day on Monday (11Jan2021) and really dizzy and had chills from then to now, which is not stopping, he means the dizziness is not better, the chills come and go. He clarifies that he did take Tylenol to treat the fever and the next day he had no fever. He says that the dizzy, he still has it. Patient took 500mg once by mouth of the Tylenol. Patient stated that he also has a history of vertigo, so he thought he was having a vertigo attack, but he took his medicine and it did not help him. Patient stated that these were not serious for him, he just feels dizzy and lightheaded. He has no loss of balance. The patient reported that he had both doses of the COVID vaccine on the left arm. Patient had the second dose on 07Jan2021, and until now he has been dizzy, it started 3 days ago (11Jan2021), he has had chills and then after he was warm all of a sudden, he was concerned. Patient has had no new medications or other vaccinations recently. He last saw his doctor six months ago and he plans to see her tomorrow (15Jan2021). The events were assessed as non-serious by the reporter. Outcome of the event dizzy/dizziness vertigo attack, and chills was not recovered (ongoing), for fever was recovered on 09Jan2021 while for other events was unknown.
28 2021-01-28 pain in extremity Fever (100.7 F), Chills, Sore arm, Fatigue
28 2021-02-01 weakness I was feeling fine for most of the day. The next day I woke up in sweats and chills but I didn?t thi... Read more
I was feeling fine for most of the day. The next day I woke up in sweats and chills but I didn?t think much of it. As I was standing up I notice all of the following- headaches, body pain, fever, low energy (although this one went away fast). I also felt like puking most of the day. I woke up at 7am and After work I took a nap. I woke up at 7pm feeling a lot better. I still had some minor headache but it went away with Advil.
28 2021-02-01 burning sensation, feeling hot initial exposure to coronavirus; COVID-19 PCR test positive; COVID-19 PCR test positive; when he wok... Read more
initial exposure to coronavirus; COVID-19 PCR test positive; COVID-19 PCR test positive; when he woke up the next morning he had a 5 minute interval of indescribable burning sensation on the face and upper torso/being hot; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program. A 28-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly on 31Dec2020 in arm at a single dose to prevent COVID. There were no medical history or no concomitant medications. He confirmed he is the physician and the primary doctor for the patient. The patient is a pharmacist and he received the first dose of the Pfizer COVID vaccine on 31Dec2020. The next day (01Jan2021), he woke up with a 5-minute interval of indiscernible burning sensation on his face and upper torso that went away after about 5 minutes. The patient reported being hot for a few seconds after taking the Pfizer COVID vaccine. The patient came in to contact with some with coronavirus and then the patient tested positive for coronavirus on 17Jan2021 with a PCR test. He had no symptoms since a week after his initial exposure to coronavirus. No adverse reactions but turned up with infection. The outcome of event burning sensation on the face and upper torso was recovered on 01Jan2021, outcome of the other events was unknown. Reporter assessed seriousness for burning sensation on face and upper torso: Medically significant. Causality between burning sensation on face and upper torso and bnt162b2 was related by Primary Source Reporter per Global Introspection. Information on the batch number/lot number has been requested.; Sender's Comments: Based on the current available information , Exposure to SARS-CoV-2 is most likely related to an intercurrent condition which is not related to the suspected drug. Based on the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of other events 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.
28 2021-02-01 tremor Mild fatigue/extreme fatigue (difficulty standing); strong chest/abdominal tightness (described simi... Read more
Mild fatigue/extreme fatigue (difficulty standing); strong chest/abdominal tightness (described similar to indigestion); strong chest/abdominal tightness (described similar to indigestion); chills (severe shaking/trembling); chills (severe shaking/trembling); deep breathing; Mild fatigue/extreme fatigue (difficultly standing); elevated temperature (99.3-7); sensitivity to cold for 24-48 hours; This is a spontaneous report from a non-contactable consumer. A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL3246) via an unspecified route of administration at right arm on 14Jan2021, at 10:00 AM at a single dose for COVID-19 immunization. Age at vaccination was 28-year-old. Medical history included blood pressure. No other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination reported as 2 - blood pressure (identity not disclosed). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL0140) at right arm on 23Dec2020 at a single dose for COVID-19 immunization and no symptoms reported. Facility where the most recent COVID-19 vaccine was administered at hospital. It was reported mild fatigue within first few hours for second dose. Around 12 hours after injection (11:30 PM) had rapid onset of strong chest/abdominal tightness (described similar to indigestion), extreme fatigue (difficultly standing), chills (severe shaking/trembling), and deep breathing. These strong symptoms lasted for around 15 minutes. Over next few hours elevated temperature (99.3-7) and sensitivity to cold for 24-48 hours. Symptoms resolved. Events with start date on 14Jan2021 at 11:30 PM. The outcome of events was resolved in Jan2021. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
28 2021-02-04 pain in extremity Hives from neck down to elbow on left side. Wet cough, chest pain over sternum and on left side llq... Read more
Hives from neck down to elbow on left side. Wet cough, chest pain over sternum and on left side llq on coughing. Fatigue, arm pain, localized swelling/inflammation.
28 2021-02-09 pain in extremity, numbness Sore arm near injection site and throughout arm; minor numbness in elbow and fingers; Sore arm near ... Read more
Sore arm near injection site and throughout arm; minor numbness in elbow and fingers; Sore arm near injection site and throughout arm; This is a spontaneous report from a contactable consumer reported for himself. A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration in left arm on 25Jan2021 14:15 at first single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. No other medical history. 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 experienced sore arm near injection site and throughout arm including minor numbness in elbow and fingers. Adverse event start date: 25Jan2021 04:30 PM. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
28 2021-02-09 seizure like phenomena Immediately after I administered the vaccine, the patient passed out. He fell onto the floor and we... Read more
Immediately after I administered the vaccine, the patient passed out. He fell onto the floor and we witnessed some oral seizure like type movement . The patient was unconscious for approximately 1.5-2 minutes. Our Chief Medical Officer was on site and walking into the room as the patient fell. We immediately placed him on his left side, protected his head, and stayed with him. We called 911 immediately due to the uncertainty of health issues. Once conscious, the patient explained to us that he experiences such every time he receives a vaccine. He was assessed by the CMO as well as the EMTs that arrived on scene. His vitals were taken. He was moved into a comfortable position and monitored. He was alert and orientated x 3. We requested he have someone pick him up instead of him driving himself home which he did. This gentleman is also an employee and we were able to see him and verify all was well in the following days. We also recommended he tell all vaccinators that he experiences LOC post vaccination. When he receives his second dose we plan to have him lying down and our CMO will be present. We recommended he follow-up with his PCP.
28 2021-02-15 feeling hot Started to feel warm and light headed. VS @ 15:15 HR 72, RR 16, BP 112/68, S02 98%
28 2021-02-16 tremor Body/head/muscle aches, nausea, dizziness, chills, mild shaking, poor attention/concentration.
28 2021-02-19 pain in extremity, feeling hot, numbness, tingling After about an hour following my second COVID-19 Injection I began feeling warm. My forehead felt w... Read more
After about an hour following my second COVID-19 Injection I began feeling warm. My forehead felt warmer so I figure I may have had a slight fever at that point. I received a metallic (Note I say metallic but I know it wasn't actually metal but that's simply the best way I can describe the taste I experienced) following the injection about 5 minutes after. My arm remained sore following and still remains sore as of this report. I experienced a decline in mental acuity following about an hour after injection. I began to feel lightheaded and exhausted to the point I was experiencing severe disorientation and confusion. I was having trouble putting sentences together and experienced a ringing sensation in the ears. I felt like I wasn't even present anymore. I couldn't comprehend things around me and apparently had conversations I don't even remember having. Note that at that point I had gotten home but don't even remember getting home. I just know that this did not begin to wear off until around 8:45pm when it was like someone flipped a switch and I suddenly was coherent again. It was an odd sensation to experience. The arm remained sore and the metallic taste returned briefly after this experience. I experienced a similar feeling from the HPV injection years ago, but just like this it was a temporary thing that resulted in no long term issues. However, I cannot tell you fully what we did the rest of the day until around 845-9 pm. I also remember becoming partly agitated after the injection like my body just all of a sudden took notice of something and shot into action. I had received my allergy injections this same day about two hours earlier as well and none of these reactions ever occur with those for me. I continued to drink liquid as far as I know as there were a few empty bottles of water next to me. I have no recollection of getting them. It's odd. There's just this brief moment in time that is just missing from my memory with a few short bits and pieces that are there like a puzzle with some missing pieces. I feel I became so fatigued I could not function. My emotions I remember were off and hard to control during this period too. I felt like I was having some random mood swings. I feel ok now though aside from the upset stomach occasionally and the fatigue and arm pain (but even the arm pain has partly decreased now). It all ceased. I have a number of health issues outside of this but have not experienced this long of a period of almost intermittent amnesia and incoherency following an injection before. I believe it made me that much more tired or reacted with one of my many conditions or genetic variants that perhaps may have been part of this. I'm happy to provide anything I can to help with this. I am greatly appreciative of all the CDC has done to get us this vaccine and continues to do to ensure our safety both before and after injection. It is commendable. I did fill out my survey through the V-Safe portal as well and will continue to follow up there should I have any changes. I have not sought medical care following this event as the coherency and such have seemed to resolve in regards to the vaccine injection. Only thing left are known side effects at this point besides an occasional increase in numbness and tingling that I already experience in my legs and feet. My absolute best guess for the cause is my immune system which already has some issues regulating (doesn't always like to learn everything it should and we are currently searching for an undiagnosed autoimmune disorder currently going on as well in me) on top of allergy shots today. it was perhaps just a bit too much demand on it all at once. But it seems to be balancing out again now.
28 2021-02-21 weakness, pain in extremity Left arm pain, headache, weakness on date of vaccination. 2 Extra strength Tylenol taken. Symptoms i... Read more
Left arm pain, headache, weakness on date of vaccination. 2 Extra strength Tylenol taken. Symptoms improved next morning.
28 2021-02-24 pain in extremity Soreness at the injection site/tenderness of arm; Soreness at the injection site/tenderness of arm; ... Read more
Soreness at the injection site/tenderness of arm; Soreness at the injection site/tenderness of arm; This is a spontaneous report from a contactable consumer (patient). This 28 -year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration, on 11Feb2021 (at 15:45) at a single dose on right arm for COVID-19 immunisation, administered at Workplace clinic. No relevant medical history and concomitant medications were provided. No known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 before vaccine. On 11Feb2021 (at 22:00), the patient had soreness at the injection site/tenderness of arm. The events were reported as non-serious. Post vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.
28 2021-02-24 tremor Uncontrollable shivering and shaking, lasting 45 minutes, relieved about 30 minutes after taking 1g ... Read more
Uncontrollable shivering and shaking, lasting 45 minutes, relieved about 30 minutes after taking 1g Tylenol
28 2021-03-02 pain in extremity Chills and Muscle aches in neck, shoulders, and arms.
28 2021-03-02 pain in extremity Had severe chest pains and pain radiating down left arm three (3) days; Had severe chest pains and p... Read more
Had severe chest pains and pain radiating down left arm three (3) days; Had severe chest pains and pain radiating down left arm three (3) days; I was diagnosed with myopericarditis (inflammation of both the lining of the heart and the heart muscle); This is a spontaneous report from a contactable consumer. This 28-year-old male consumer reported that: Report about Covid vaccine: Yes Reporting type: AE Reporter type: Patient Age group: Adult (18-64 Years) Current age: 28 Current age unit: Years Gender: Male Patient occupation: None of the above Covid vaccine details: (product=COVID 19, brand=Pfizer, lot number=EL3246, lot unknown= False, administration date=18Jan2021, administration time= 04:00 PM, vaccine location= Right arm, dose number= 2), (product= COVID 19, brand=Pfizer, lot number= EJ1685, lot unknown= False, administration date= 29Dec2020, administration time=11:00 AM, vaccine location= Right arm, dose number=1) Facility type vaccine: Hospital If other vaccine in fourweeks: No Other medications in twoweeks: No Adverse event: Had severe chest pains and pain radiating down left arm three (3) days (Thursday 21Jan2021) after receiving the second Pfizer COVID vaccine (lot:EL3246) on Monday 18Jan2021. I was admitted to the hospital the same day, and was discharged on Saturday 23Jan2021. I was diagnosed with myopericarditis (inflammation of both the lining of the heart and the heart muscle). I was given a 90 day prescription of colchicine 0.6mg and I am still currently taking the medication twice daily with 1g of Tylenol (acetaminophen) once daily. Adverse event start date: 21Jan2021 Adverse event start time: 03:00 AM AE resulted in: [Emergency room/department or urgent care, Hospitalization] No days hospitalization: 3 If patient recovered: Recovered If treatment AE: Yes AE treatment: Colchicine 0.6 mg tablet (twice daily) If Covid prior vaccination: No If Covid tested post vaccination: Yes Covid test post vaccination: (covid test type post vaccination=Nasal Swab, covid test date=21Jan2021, covid test result=Negative) Known allergies: Penicillin/Amoxicillin Other medical history: No
28 2021-03-04 migraine, mild one side paralysis 18 days after Covid Vaccine Dose 1, patient started to present with symptoms of a frontal lobe migra... Read more
18 days after Covid Vaccine Dose 1, patient started to present with symptoms of a frontal lobe migraine along with nausea, dizziness, and L Sided Weakness. As time continued to pass while en route to local hospital, patient began to stutter harshly, saying every other word in a sentence, complained of a stiff jaw, and began to panic.
28 2021-03-06 flushing 7-10 minutes after vaccine patient becae flushed, diaphoretic , nauseated and started vomiting. Mild... Read more
7-10 minutes after vaccine patient becae flushed, diaphoretic , nauseated and started vomiting. Mildly hypotensive BP 101/60. Symptoms resolved after 30 min with IM dose Benadryl and promethazine. BP on discharge 122/70
28 2021-03-10 weakness I had dermatitis reaction. My body was full of itchy and painful rash followed by weakness and body ... Read more
I had dermatitis reaction. My body was full of itchy and painful rash followed by weakness and body aches. Treatment: Benadryl 1 tablet single dose.
28 2021-03-11 unresponsive to stimuli Pt fell out of his chair landing on the right side of his body. Unresponsive 2-3 seconds. He was ... Read more
Pt fell out of his chair landing on the right side of his body. Unresponsive 2-3 seconds. He was able to respond verbally immediately p initial unresponsive episode asking "how long was I out for?" Pt is alert and oriented to person, place time situation "highlight headed. He did not eat breakfast. 0935AM HR 67, SpO2 98%, RR 22, BP 152/94. At 1950 AM HR 84, SpO2 97%, RR 22, BP 136/84. At 1015AM 8 oz water, granola bar snack, Capri-sun, consumed and he felt better. No injuries noted from falling out of chair. At 1026AM called -made it to work.
28 2021-03-14 unresponsive to stimuli 4:07 pm Vaccinating nurse said client was unresponsive to verbal stimuli, breathing even and unlabor... Read more
4:07 pm Vaccinating nurse said client was unresponsive to verbal stimuli, breathing even and unlabored. 4:08 pm client alert and orientated. According to patient, "I usually faint when I receive any vaccine of by blood pressure taken." 4:10 pm Client evaluated by onsite Paramedics. 4:12 pm client able to ambulate without any difficulties. 4:15 pm client expressed a phobia of needles. 4:40 pm client placed on 30 mins. of additional observation. 4:55 pm no additional symptoms observed and paramedics released to go home. 5:00 pm client released.
28 2021-03-15 numbness prolonged numbness in left pinky finger and occasionally the adjacent finger/first noticed this on l... Read more
prolonged numbness in left pinky finger and occasionally the adjacent finger/first noticed this on left shoulder/numbness radiated to shoulder maybe once or twice, but has been more prolonged in pinky finger; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on 26Jan2021 at 15:45 pm (at the age of 28-years-old) on left arm at single dose for covid-19 immunisation. Medical history was none. No Known allergies. Allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included linoleic acid (CLA), l-carnitine [levocarnitine] (L-CARNITINE [LEVOCARNITINE]), cocos nucifera oil (MCT OIL [COCOS NUCIFERA OIL]) as dietary supplements. The patient reported that, I noticed mild numbness on my left side the same night I had received the vaccine on 26Jan2021 at 20:00 PM. This has quickly faded over the course of the next day, however a week later (about 2 days prior this submission) I noticed prolonged numbness in my left pinky / sometimes adjacent finger. On occasion (once or twice) I have felt slight pain in my left shoulder and left foot. Pinky finger is currently still numb. I am unsure if I pulled a nerve while exercising or if this is an adverse reaction to the Pfizer Covid vaccine. He will be scheduling a checkup with his PCP to get a diagnosis, but informed me as his manager and I'm hereby reporting it as an adverse event. The event was considered as non-serious. 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 was received for the adverse event. The patient was not recovered from the event. Information about lot/batch number has been requested.
28 2021-03-15 tingling Full body rash, itchy, pins and needle feeling all over the body. Some joint pain. Noticed the day a... Read more
Full body rash, itchy, pins and needle feeling all over the body. Some joint pain. Noticed the day after the second shot. Got progressively worse over the next day. I Saw PCP Doctor Friday and Dermatologist On Monday. The treatment has been bed rest, 4mg MethlPREDNISolone and Clobetasol 0.05%. Some of the rash is clearing up.
28 2021-03-15 tremor Patient got vaccine and went to restroom once given despite being told to wiat 15mins before going. ... Read more
Patient got vaccine and went to restroom once given despite being told to wiat 15mins before going. After 10mins of being vaccinated patient stated not feeling well. His face became pale and bacame shaky and sweaty. We laid him on the ground and elevated his ffet and called 911. Patient felt batter and was sitting in chair when parmedics arrived. Once the paramedics arrived patient had another episode as previouse and threw up. After a while patient states he had 2 beers before coming for the vaccine and had it on an empty stomach. Pstient was taken by paramedic to hospital for evaluation.
28 2021-03-18 migraine, cold sweat migraine; Fever; mild chills/uncontrollable heavy shivering; cold sweats; Mild muscle pain at inject... Read more
migraine; Fever; mild chills/uncontrollable heavy shivering; cold sweats; Mild muscle pain at injection site; This is a spontaneous report from a contactable healthcare professional (the patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration in the left arm on 14Feb2021 07:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: ADHD (attention deficit hyperactivity disorder), severe migraine, unknown vestibular event in June-Jul2020 attributed to vestibular migraines based on normal CT, MRI, and EEG. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), amitriptyline, caffeine/ paracetamol (EXCEDRIN), 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 VACCINE, lot number EL4262), via an unspecified route of administration in the left arm on 26Jan2021 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Feb2021, the patient experienced mild muscle pain at injection site onset 1 hour after injection (at 08:30) lasted about 24 hours. At 01:20 on 15Feb2021, also reported as 17 hours 10 minutes post-injection, the patient woke up with mild chills, temperature (oral thermometer) was 97.6°F. Chills and cold sweats progressed rapidly, with severe chills and uncontrollable heavy shivering and sweating present within 10-15 minutes (on 15Feb2021). Temperature at 02:00 15Feb2021 was 103.0°F. Fever slowly waned without medication. By 04:30, fever at 101.2°F, chills mild, sweating persisted. At 07:00 15Feb2021, the patient started to develop early stages of migraine (preexisting condition), took EXCEDRIN 565 mg tablet x 2. At 08:00 15Feb2021, the temperature was 98.2°F. By 10:00 15Feb2021, the fever resolved, temperature 97.6 (individual baseline) and chills had resolved. Sweating has improved to be more mild, but persistent now at 16:30 15Feb2021. Treatment was received for migraine. No treatment was received for the other events. The clinical outcome of mild muscle pain at injection site was recovered on 15Feb2021 08:30, chills and fever both recovered on 15Feb2021 10:00. The clinical outcome of cold sweats and migraine was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
28 2021-03-18 seizure Aggressive convulsions, in 5 minute spurts, with pauses between, for roughly 3 hours 11:00pm to 2:00... Read more
Aggressive convulsions, in 5 minute spurts, with pauses between, for roughly 3 hours 11:00pm to 2:00am.
28 2021-03-18 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
28 2021-03-19 cold sweat Patient received vaccine at 12:30pm, at 12:35 pm, patient felt dizzy and felt like he had a lump in ... Read more
Patient received vaccine at 12:30pm, at 12:35 pm, patient felt dizzy and felt like he had a lump in his throat that made it hard to swallow. Upon assessment, patient had constricted pupils, skin was cold and clammy. Patient respirations were rapid but unlabored. Nurse administered 25mg of benadryl and had patient drink Pepsi while waiting for an ambulance. Ambulance arrived at 12:52 and assessed patient. At 13:09, patient refused vital signs by squad and refused to be evaluated at hospital, stating he was feeling much better and thinks he just had an anxiety attack due to witnessing another patient have a reaction. Patient stayed onsite with nurse until 14:00, when he called someone to come drive him home. Patient texted nurse at 15:40 stating he arrived home safely and felt fine.
28 2021-03-22 tremor Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: shaking-Mild, Systemic: Shakines... Read more
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: shaking-Mild, Systemic: Shakiness-Mild
28 2021-03-24 migraine deathly sick; deathly sick; high fever; throwing up; massive migraine; dehydration; This is a sponta... Read more
deathly sick; deathly sick; high fever; throwing up; massive migraine; dehydration; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the parent, reported that a 28-year-old male patient (son) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 vaccination. Medical history included Crohns disease (caller concerned because HUMIRA causes immunosuppression). Concomitant medication included adalimumab (HUMIRA) for Crohns disease. After the first dose, the patient became "deathly sick" with the following: high fever, throwing up, massive migraine. These symptoms occurred approximately 5-7 days post vaccination. The patient went to ER (emergency room) and was given IV fluid for dehydration, no other diagnosis, but was told it could be related to the dose of vaccine. The outcome of the events deathly sick, high fever, throwing up, massive migraine and dehydration was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
28 2021-03-25 pain in extremity 24 hours following administration patient developed body aches, fever (101), sore throat and nausea.... Read more
24 hours following administration patient developed body aches, fever (101), sore throat and nausea. 72 hours after receiving the shot he developed sudden onset substernal chest pain described as sharp and burning with radiation to his bilateral arms.
28 2021-03-26 pain in extremity Extremely sore arm, beginning only several minutes after injection, persisting at least several seve... Read more
Extremely sore arm, beginning only several minutes after injection, persisting at least several several hours and days, painful to move, difficult to use for normal tasks Fatigue, sleepiness,
28 2021-03-28 cold sweat Patient is a 28 year old male who has completed a 45-minute observation period with the following si... Read more
Patient is a 28 year old male who has completed a 45-minute observation period with the following signs and symptoms of an adverse reaction: other - syncopal episode. COVID-19 vaccine # 1 in series administered. Patient complaints of syncopal episode witnessed by other patients after received 1st dose of Covid vaccine. Patient states that he developed clammy skin, lightheadedness 10 minutes after he received his Covid vaccine, patient tried to get out of chair when he had a syncope episode and fell on the floor face down witnessed by other patient in the Covid vaccine lobby area. Denies any head or facial injury. Patient states that he has needle phobia and he forgot to tell the nurse about his needle phobia. Treatment provided/action Taken: Vital sign @ 1325: blood pressure 114/44, heart rate: 71. SPO2: 98%, respiration : 16; Vital sign @ 1335: blood pressure 104/62, heart rate: 82. SPO2: 95%, respiration : 16; Vital sign @ 1352: blood pressure 102/68, heart rate: 90. SPO2: 99%, respiration : 16; Patient states that he didn't eat breakfast or lunch today, able to tolerated fluid and intake well, eating chocolates. Action taken: Transferred to higher level of care ( urgent care ); Patient advised to discuss second dose considerations with a clinician.
28 2021-03-29 hot flush Fatigue, body aches, headaches, hot flashes (no fever), chills, decreased concentration, heart rate ... Read more
Fatigue, body aches, headaches, hot flashes (no fever), chills, decreased concentration, heart rate spikes, mild nausea, malaise. Effects lasted through the evening of vaccination date and the following two days.
28 2021-03-30 weakness Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium... Read more
Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: symptoms occured 30-45 minutes after vaccination -Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Said he felt dizzy when he got up (about 10 minutes post) to go to restroom. He said he sat for an additional 30 minutes then left. While driving he felt lightheaded and pulled over. He also reported stomach cramps at that time. He felt better and drove back to the store. NP looked at him and checked bp and O2 sat level. Bp was little low. Advised have someone pick him up and he felt any worse to go to urgent care. After 15 minutes pt said he felt much better and left. Unable to reach f/u.
28 2021-04-01 numbness, tingling Tingling sensation throughout body 1 hour after vaccination, followed by numbness. 1 hour and 20 m... Read more
Tingling sensation throughout body 1 hour after vaccination, followed by numbness. 1 hour and 20 minutes after the vaccination my face started swelling.
28 2021-04-01 migraine I initially got a bad migraine three days after the first vaccine. Since then I?ve experienced dizzi... Read more
I initially got a bad migraine three days after the first vaccine. Since then I?ve experienced dizziness, anxiety, blurred vision, headache, and constant tinnitus. I decided to have my second shot which I had today.
28 2021-04-01 muscle twitching Constant twitching in right eye, and above left ear.
28 2021-04-04 flushing Mother called to report information for son. All information documented was information obtained. Lu... Read more
Mother called to report information for son. All information documented was information obtained. Luanne counseled to have son contact PCP for further recommendation. 04/02/2021, symptom of nausea, headache and feeling flushed instantly after receiving the vaccine. Client did not report symptoms or wait 15 minutes prior to leaving mass clinic. Symptoms on 04/02/2021 were resolved by morning of 04/03/2021. On 04/04/2021, client woke with swollen eyes and red blotches to face. Client took 50mg of Benadryl, 3 times on 04/04/2021. Symptoms improved over the day, but did not resolve.
28 2021-04-04 flushing Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported chill... Read more
Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported chills and sweat
28 2021-04-05 feeling hot, weakness Light headed, faint, weak, hot, sweating. Complained about throat tight and difficulty breathing. Pr... Read more
Light headed, faint, weak, hot, sweating. Complained about throat tight and difficulty breathing. Provided patient with ice pack for back of neck and wrist. Due to patient complaining of difficulty breathing, 911 was called and he was assessed by EMS personnel.
28 2021-04-05 tingling RNs x 2 responded to pt's vehicle c/o nausea, left arm tingling. RN reported pt was visibly "panick... Read more
RNs x 2 responded to pt's vehicle c/o nausea, left arm tingling. RN reported pt was visibly "panicked " and self-reports he "passed out twice:" after seeing blood after getting vaccine. RN reported pt had small of blood on bandaid. Reports history of anxiety, especially r/l blood needles
28 2021-04-05 unresponsive to stimuli Patient received Pfizer vaccine as IM into left arm at approximately 10:05am on Tuesday 4/6/2021. Pa... Read more
Patient received Pfizer vaccine as IM into left arm at approximately 10:05am on Tuesday 4/6/2021. Patient had a vasovagal response at 10:20am on Tuesday 4/6/2021. Patient fell out of chair, face down onto gym floor. This RN went over to patient. Patient noted to be unresponsive, however after 30 seconds woke up and was alert and oriented x 4. Patient log rolled onto back and noted to be pale and diaphoretic. EMS called by RN at 10:20. Initial set of vital signs BP 132/80, SpO2 98% on room air, HR 90 and RR 20. Legs elevated onto chair and patient remained lying flat on his back until EMS responded. EMS initial arrival at 10:49 am ... EMS response time 33 minutes with arrival onsite at 10:53am. Patient taken to hospital by EMS.
28 2021-04-06 pain in extremity . Pfizer dose 1 on 3/30. Just had sore arm. Symptoms dizziness began on 4/3. Otherwise feeling well.... Read more
. Pfizer dose 1 on 3/30. Just had sore arm. Symptoms dizziness began on 4/3. Otherwise feeling well. Labs drawn 4/5 which revealed pancytopenia, rechecked today and numbers are worsening. Working to get him into hematology now. 28 yo male s/p Covid-19 Vaccine (Pfizer) on 3/30 with lightheadedness only when bending down and coming up returns for follow up today for pancytopenia found on labs obtained 4/5. He denies any recent viral symptoms. He did not have any episodes in past that made him question that he may have had Covid-19 viral illness. He is able to tolerate his normal daily exercise and bike without any symptoms. He has no dietary restrictions, eats dairy, meat, lots of vegetables/fruits, pastas and some breads/cereals. He drinks alcohol once per week. He abstains from ETOH every April. He has used edible THC in past, only once per month at most. He has not been tested for HIV in past. His girlfriend, in last semester of school advised him to ask about HIV testing. He denies any chest pain, SOB, HA. Upon review of his lab results yesterday, I called the hematology fellow, Dr. through program at hospital and he recommended the labs to be obtained and rechecking labs in one week. He felt the student was not exhibiting any emergent symptoms requiring emergent evaluation. Patient and I spoke on phone after this call with fell at 1557 4/6 and I advised him to seek emergent medical eval in ED for any CP, SOB, HA or any neurologic symptoms. Patient has not had any of those symptoms. He exercised this morning without difficulty. He notes raised papules on legs which he has had in past. They have currently been present for a few days. He believes it to be related to biking in sweatpants. He has been in a hot tub recently, but after the bumps were present. They do not itch. He has had them in past, more in winter months with heavier clothing. He also notices slight left arm pain today. This was site of his vaccine. He denies any swollen lymph nodes. He is notices only with arm movement. He denies any FH of blood disorder/ blood cancers/MDS. He denies bruising, bleeding or dark stools. He states he likely has not had a blood draw in past, unless one visit to ER, for HA/concussion in high school (9+yrs ago) resulted in any blood test.
28 2021-04-06 seizure Pt started to faint and then had a seizure. The patient awoke from seizure and 1 minute later had an... Read more
Pt started to faint and then had a seizure. The patient awoke from seizure and 1 minute later had another seizure. EMS arrived and took the patient to a hospital facility.
28 2021-04-07 migraine migraine; nausea; nausea followed by vommiting; mild headache; This is a spontaneous report from a c... Read more
migraine; nausea; nausea followed by vommiting; mild headache; This is a spontaneous report from a contactable consumer (Patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9262) via unspecified route of administration on 11Feb2021 10:00 AM at single dose for covid-19 immunization. Medical history included Psoriasis - Take Stelara every 12 weeks for it. The patient had no known allergies. 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 multivitamins in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 on 22Jan2021 10:00 AM at left arm single dose for Covid-19 immunization (Lot number: EN6201). It was stated on 13Feb2021 at 06:00 PM, 50-60 hours after injection- migraine that lasted for about 6 hours , nausea followed by vomiting, no fever even after 3-4 days still mild headache. No therapeutic measures were received for all the events. The outcome of the events were recovering.
28 2021-04-07 unresponsive to stimuli Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Joint Pain-Mild, Additional Details: Patient passed out hit his head while dropping to the ground. Paramedic was called and came. He was fine after, but called a ride to get him to be on the safe side.
28 2021-04-08 grand mal seizure Generalized tonic clonic seizure with post-ictal state, 1 minute after the shot, 2 episodes, each l... Read more
Generalized tonic clonic seizure with post-ictal state, 1 minute after the shot, 2 episodes, each lasting about 15 seconds. -stable vital signs, patient has no prior h/o seizure disorder, no h/o allergies to food, vaccine or meds, -patient was not on any meds at the time. -patient was stabilized and transferred to the ER for further evaluation.
28 2021-04-08 unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Fainted due t... Read more
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Fainted due to fear of needles-Medium, Additional Details: Patient has fear of needles and passed out after administration- EMS called to assess him and he was cleared to go home. No pain at injection site, no adverse effects from vaccine
28 2021-04-09 pain in extremity First day I only had a sore arm Second day, typical malaise, flu-like symptoms Third day I saw impro... Read more
First day I only had a sore arm Second day, typical malaise, flu-like symptoms Third day I saw improvement but still malaise. I tried a 500mg tumeric curcumin suppliment which was new for me ~5 hours later I noticed brain fog and my vision was not as clear. Over the next 3-4 days my brain stem/back brain started to throb/vibrate occasionally, and I got very bad tinnitus.
28 2021-04-09 tremor Mother and patient reports directly after injection patient experienced chills and shaking. That res... Read more
Mother and patient reports directly after injection patient experienced chills and shaking. That resolved within 3-4 hours. The next morning he woke up with a sore throat that felt swollen that persisted through today 4/10/21.
28 2021-04-10 feeling hot Feeling hot, Dizzy and Nauseous
28 2021-04-11 pain in extremity Slight fever and sore arm. Went away not long after and fine now! Took some Tylenol.
28 2021-04-12 tingling, numbness Swelling; Numbness; Tingling; received the most recent COVID-19 vaccine subcutaneously; This is a sp... Read more
Swelling; Numbness; Tingling; received the most recent COVID-19 vaccine subcutaneously; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 subcutaneously administered in left arm on 29Mar2021 12:45 (Lot Number: 1239921-00) as a single dose for covid-19 immunisation. Medical history included type 1 diabetes and allergic to tempeh (it's a food). The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medication included amoxicillin (AMOXICILLIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine subcutaneously in a pharmacy or drug store. On 29Mar2021 14:00, the experienced swelling, numbness and tingling which was considered serious since the patient was hospitalized (unspecified date in 2021) for 1 day (unspecified date in 2021). The adverse event required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The events required treatment which included Benadryl. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovered on an unspecified date in 2021 with sequel.
28 2021-04-12 seizure I got the Covid 19 Vaccine Pfizer at the pharmacy. After I got the Vaccine I was waiting in the wait... Read more
I got the Covid 19 Vaccine Pfizer at the pharmacy. After I got the Vaccine I was waiting in the waiting room for 15 minutes but before my time was up and it was my time to leave I felt really dizzy & light headed as I was sitting down on a chair. Then I just felt some one tell me to wake up because I had fainted, fell face down to the floor & convulsed for 5 seconds.
28 2021-04-12 tremor Almost immediately after receiving the vaccine, I started having really bad blepharospasms which I h... Read more
Almost immediately after receiving the vaccine, I started having really bad blepharospasms which I had not had for about a month and started having general shaking throughout, but especially in my legs. Much of these side-effects began to subside upon the self-administration of clonezepam, but not completely There is a still a lot of pain at the injection site as well as fatigue
28 2021-04-13 weakness, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: sweating-Severe, Systemic: Flushed / Sweating-... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: sweating-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Weakness-Mild
28 2021-04-13 pain in extremity Client fell out of chair and hit his head. Began to seizure Left arm pain after pfizer injection. EM... Read more
Client fell out of chair and hit his head. Began to seizure Left arm pain after pfizer injection. EMS called
28 2021-04-14 feeling hot Pt vaccinated and immediately felt, hot, sweaty, faint. Hx of having similar reaction to vaccines in... Read more
Pt vaccinated and immediately felt, hot, sweaty, faint. Hx of having similar reaction to vaccines in the past. No medical problems. No medications. Ate a "snack" this AM. Drank fluids this AM. Pt wheeled without incident to triage area. Feeling a little better after drinking 16 oz water. Appears A & O X 3, no distress, diaphoretic, skin warm and moist to touch Mood and affect normal Initial vitals 10:30 am - P78 PO2 95% RA BP 113/62 Repeat vitals 1040 am P71 PO2 97% BP 104/56 Repeat vitals 1046 am P76 PO2 97% BP 100/57 Repeat vitals 1048 am P76 BP 102/61 Reports feeling better after water and Gatorade. Pt advised hydration. Advised immediate medical attention should symptoms persist or worsen Hypotension , Hypotension
28 2021-04-14 hot flush Hot flashes, fatigue(lasting 24 hours), drowsiness (slept for 18 hours the next day), lower back pai... Read more
Hot flashes, fatigue(lasting 24 hours), drowsiness (slept for 18 hours the next day), lower back pain,
28 2021-04-15 weakness Approximately 10 minutes after receiving the COVID vaccine (second dose) pt. Experienced a fainting ... Read more
Approximately 10 minutes after receiving the COVID vaccine (second dose) pt. Experienced a fainting episode, with the possibility of loosing his pulse for approximately 30 seconds according to RN. Pt. Was in his vehicle in the monitoring area. When RN arrived after approximately 1 minute, the patient had a strong carotid pulse of around 80. Airway was maintained until patient woke up. Pt stated that he had not eaten before coming. BP's follow: 1230:99/64, P-48-Sat 94% 1243:109/74,P-67,Sat-97% 1248: 102/63,P-73,Sat-95% 1253-106/72,P-68, Sat-93& 1258-105/64,P-66, Sat-94% 1305-106/73,P-63,Sat 95%. 1311-112/74,P-59,Sat 94% 1316-99/68,P-59, Sat 92% 1322-112/73,P59, Sat 94% Pt remained weak and nauseous for approximately 45 minutes. It was decided at that time he would need to go to the ER and EMS was called. At approximately 1330 Pt. Was assisted to the stretcher and transported to ER for further evaluation. ED physician determined that patient had a vasovagal reaction to the vaccine and was discharged home.
28 2021-04-15 flushing Patient experienced flushing and sweating. BP 98/53 P86 RR18. No signs of respiratory distress, vita... Read more
Patient experienced flushing and sweating. BP 98/53 P86 RR18. No signs of respiratory distress, vitals stable. Patient given orange juice and crackers, felt better, possible lower blood sugar episode. Did not eat for more than 6hrs prior to vaccination. Discharged in stable condition.
28 2021-04-15 muscle twitching, seizure patient sitting in post-vaccination area has a witnessed seizure at 1525, patient had twitching, LO... Read more
patient sitting in post-vaccination area has a witnessed seizure at 1525, patient had twitching, LOC and eye rolling. EMT and RN were there and observed. Patient returned to consciousness, and moved behind curtin. Patient had another witnessed seizure @ 1532 lasting 10 seconds, with LOC, twitching, eyerolling and vomiting. Patient came to and placed on floor, alert and awake, able to answer questions but feeling foggy. EMS was called during 1st seizure. EMS arrived and took patient to hospital @ 1558.
28 2021-04-15 tingling Soreness at the place of injection beginning around 12:10 pm, stomach ache beginning around 7:00 pm,... Read more
Soreness at the place of injection beginning around 12:10 pm, stomach ache beginning around 7:00 pm, followed almost immediately by tingly feeling in arms and legs. Lost movement below the elbow for 3-5 minutes around 7:15 pm. By loss of movement, I mean my fingers tensed up, fully extended, and I was unable to relax or move them at all.
28 2021-04-17 involuntary muscle movements 4/18/2021 , 11:15 - Upon getting his First dose of Pfizer Vaccine, Patient seen in his chair having ... Read more
4/18/2021 , 11:15 - Upon getting his First dose of Pfizer Vaccine, Patient seen in his chair having generalized jerking movements, arms and legs were extended, both eyes were rolling. 911 called and EMS came. Patient refused to be taken to the hospital.
28 2021-04-17 feeling hot IMMEDIATELY AFTER VACCINE PT EXPERIENCED A "HOT FEELING" AND LIGHTHEADEDNESS. PT WAS TRASNPORTED TO ... Read more
IMMEDIATELY AFTER VACCINE PT EXPERIENCED A "HOT FEELING" AND LIGHTHEADEDNESS. PT WAS TRASNPORTED TO OBS VIA WC AT 1032. PT REPORTS HE IS FEELING BETTER ALREADY. WATER AND SNACKS GIVEN. VSS. PT RELEASED BY SELF AT 1043. PT ESCORTED BY STAFF TO EXIT WITH NO FURTHER ISSUES. VITALS AS FOLLOWS: 1036 SITTING BP 122/81 HR 86 SPO2 98 1042 STANDING BP 116/73 HR 72 SPO2 98
28 2021-04-18 feeling hot The patient received the vaccine on 4/18/21 at 12:56pm. As he was waiting 15-minute post-administrat... Read more
The patient received the vaccine on 4/18/21 at 12:56pm. As he was waiting 15-minute post-administration, he walked to the front, (~1 minute post-administration) and fainted. He was caught by his girlfriend and brought down to the floor, where he remained sitting. No injuries reported, reported no nausea, was oriented, held a normal conversation, reported being hot, temp was 95.5F. Paper towel soaked in cold water was applied to forehead, and gave him water to drink. Declined juice. The patient mentioned he had a reaction to a flu vaccine in the past where he was very ill after. He expressed a fear of needles, and he has fainted after bloodwork previously. EMS evaluated, patient declined hospital visit.
28 2021-04-18 muscle twitching About 24 hours after patient got his second dose of the Pfizer Covid-19 vaccine, he started to get m... Read more
About 24 hours after patient got his second dose of the Pfizer Covid-19 vaccine, he started to get muscle twitches throughout the entire body. This lasted for 24 hours, and then reduced to legs only. He now has leg twitches, chills and flu-ish symptoms that have continued to today, Monday April 19, 5 days after the second dose.
28 2021-04-19 pain in extremity right arm axilla lymph node swelling, fatigue, headache and right arm pain
28 2021-04-19 pain in extremity Soreness in the left arm from 3 hours after shot. Headache and elevated temperature in the late afte... Read more
Soreness in the left arm from 3 hours after shot. Headache and elevated temperature in the late afternoon and evening. Fever and chills in the evening. Headache continued in the morning of April 20th. Took 200 mg ibuprofen, 50mg zinc and 2 tbsp elderberry.
28 2021-04-20 muscle spasms, weakness, tremor, seizure, discomfort seizures/Convulsions; weird metal or acidic taste in my mouth; felt heavy; feel shaky; back spasms; ... Read more
seizures/Convulsions; weird metal or acidic taste in my mouth; felt heavy; feel shaky; back spasms; blood pressure spiked to higher than normal levels; nauseous; weakness on my left side; pain at the injection site; pain at the injection site, my back, and neck; pain at the injection site, my back, and neck; feel super tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 06Apr2021 11:15 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included axenfeld reigers, bilateral congenital iris coloboma, bilateral glaucoma, hearing loss. Known allergies: peanut, albuterol, amoxicillin-pot clavulante, doxycycline, fentanyl, levosalbutamol (LEVALBUTEROL), oxycodone-acetaminophin, sedation. Concomitant medications in two weeks: cryofood (unspecific), folic acid, cyanocobalamin (B12), timolol and dorzolamide hydrochloride/timolol, all from unknown date for unknown indication. First, patient had a weird metal or acidic taste in mouth. Following that, patient felt heavy. Next, began to feel shaky having back spasms. His blood pressure spiked to higher than normal levels and started feeling shakey dropped. Patient was laid down by nursing staff and blood pressure dropped. After being laid down, patient started having seizures/convulsions, paramedics were called and patient was given midazolam hydrochloride (VERSED, anti-seizure meds) and was taken to the ER (emergency room). Once patient arrived at the ER, he felt nauseous and was given anti-nausea medication, after about 4 hours patient was released. But he was experiencing weakness on left side and pain at the injection site, back, and neck, and felt super tired. AEs onset at 11:30 of 06Apr2021. Outcome of the events was resolving. Patient had no COVID prior vaccination and had no COVID tested post vaccination.
28 2021-04-20 tremor Whole body aches and trembling, fever, lightheaded, nauseated, vomiting
28 2021-04-20 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted for a few seconds while sitting in observation for 15 minutes. almost 15 minutes had lapsed and fell to the floor. bumped head mildly on the groud. immediate response. a little disorientated. gave water and granola bar. pt did not drink or eat anything all day . sat for 30 extra minutes and felt better. advised to check with md.
28 2021-04-21 numbness, tingling Pt contacted health clinic on Apr 22 at approximately 0900 stating he was experiencing numbness and ... Read more
Pt contacted health clinic on Apr 22 at approximately 0900 stating he was experiencing numbness and tingling in his right arm/hand, no other symptoms/side effects stated. Pt indicated that symptoms started yesterday morning, Apr 21 and got worse this morning when he woke up which prompted him to contact the clinic. Pt was instructed to f/u at urgent care/er to rule out other medical conditions.
28 2021-04-22 weakness Headache, body ache, tiredness, lack of energy.
28 2021-04-22 bell's palsy Bells palsy came into effect 1 week after the first Pfizer shot
28 2021-04-23 seizure Patient at pharmacy and sitting in chair after receiving vaccine. Patient slumped in his chair and ... Read more
Patient at pharmacy and sitting in chair after receiving vaccine. Patient slumped in his chair and had seizure x 2, incontinent of urine. Patient to ER and neurology consult.. Neurology diagnosed convulsive syncope. No further treatment. Patient discharged home.
28 2021-04-24 cold sweat Patient became for clammy, dizzy, low pulse rate, low blood pressure, blue lips, somewhat incoherent
28 2021-04-24 pain in extremity Received the vaccine at 10:;15 am on 4/14/2021 and had fatigue, slight chills, and a sore arm. By ... Read more
Received the vaccine at 10:;15 am on 4/14/2021 and had fatigue, slight chills, and a sore arm. By 4/16/2021 I felt normal until approx. 10pm when my right ear blocked up and I lost hearing in my right ear. On 4/17/2021 I treated it as a congestion issue with neti pot and decongestions but the ear remained blocked. After sleeping for approx 1 hour on 4/17/2021 I woke up at approx. 11pm with severe vertigo and nausea and vomited consistently for approx 1 hour. I could not get off of the floor and the right side of my face was fixated to the floor. Paramedics were called and I was taken to the ER where I was treated with anti-nausea medications and valium to reduce vertigo. A non contrast CT, blood panel, and stroke assessment were all normal with no sign of ear infection. I was release from the hospital at 10am on 4/19/2021. On 4/21/2021 I saw an ENT who performed a hearing exam revealing my right ear is completely deaf with normal left ear function. The ENT prescribed prednisone 10mg (63 tablets over 10 days). As of today (4/25/2021) I no longer have vertigo and nausea, but I still have no hearing in my right ear and have significant vestibular challenges and cannot walk safely unassisted without getting dizzy.
28 2021-04-24 tension headache, weakness afraid to take second dose of Pfizer COVID-19 vaccine due to the events; brain fog every single day;... Read more
afraid to take second dose of Pfizer COVID-19 vaccine due to the events; brain fog every single day; kind of off and uneasy; body aches; slight dizziness not like he was going to fall over, but cant stand still without lean a little/felt immediate rush to the head and feeling of fainting; very weird like an out of body experience this was almost like an anxiety attack/anxiety attacks for every 30 minutes or so; tension headaches; Chills; tunnel vision/tunneled, it was like tunnel vision and a very very weird like an out of body experience this was almost like an anxiety attack; it was extremely intense; pain at the injection; insane rush from the bottom of his feet to the top of head, felt like he was going to pass out; weakness; This is a spontaneous report from a contactable consumer (Patient). A 28-year-old male patient received first dose of BNT162B2 (Pfizer COVID Vaccine, solution for injection, Lot Number: ER8733; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 28Mar2021 at 17:00 (at the age of 28 years-old) as single dose for COVID-19 immunization. Medical history included ongoing asthma, anxiety experienced years and years ago when he was about 19-20 years old and it has been under control, he hasn't had this happen in years. The patient mother suffers from slight anxiety at times; dad currently has high blood pressure. Concomitant medication included albuterol sulfate taken for asthma (in inhalation (90mcg per actuation 200 metered inhalations: 2 puffs as needed) and liquid form (0.083% 2.5 mg out of 3ml as needed) for nebulizer since he was born). Patient did not have COVID prior vaccination. Patient did not want to contract COVID-19 because he has asthma. On 28Mar2021 at 17:00 (within 5 minutes of vaccination), patient experienced Tunnel Vision, chills, weakness, insane rush from the bottom of his feet to the top of head, felt like he was going to pass out (which was recovered same day with lasting effects), weakness, hasn't felt the same; feels like something is off every day; not himself, very weird like an out of body experience this was almost like an anxiety attack/anxiety attacks for every 30 minutes or so, tension headaches, dizziness and felt immediate rush to the head and feeling of fainting, at 8PM or 9PM, he felt pain at the injection and body aches. The patient visited physician room as a result of Insane tension headaches, and anxiety. On 29Mar2021, he didn't really feel too anxious, but he felt out of place, kind of off and uneasy. The chills and body aches, kind of off and uneasy were disappeared on 30Mar2021. On 31Mar2021, brain fog and slight dizziness does not like he was going to fall over but cant stand still without lean a little/felt immediate rush to the head and feeling of fainting. On 02Apr2021, injection site pain was gradually faded away. The patient states that these events started after the Pfizer COVID 19 vaccine. Therapeutic measures were taken as a result of events included Tylenol. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal swab): Pending on 06Apr2021. The patient did not take any other vaccinations four weeks prior to vaccination. The patient was afraid to take second dose of Pfizer COVID-19 vaccine due to the events. Patient felt very hard to work with these symptoms and to get through everyday life, it is very tough. Patient knows plenty of people that died from COVID-19 and he does not want to have to make changes and fix things in his life that he did not cause and worries this will stick around for the rest of his life all because he took a vaccine. The patient had physician office and Emergency room visit. The outcome of the events insane rush from the bottom of his feet to the top of head, felt like he was going to pass out, pain at the injection, chills and body aches were recovered, while for tension headaches, anxiety attacks, dizziness, weakness, brain fog, hasn't felt the same; feels like something is off every day; not himself was not recovered, and for tunnel vision it was unknown. Information on the lot/batch number has been requested.
28 2021-04-25 hot flush, feeling cold, cold sweat PATIENT EXPERIENCED A "HOT FLASH' AND TIGHT THROAT AT ITHE 15 MIN MARK, COLD AND CLAMMY FOREHEAD, 1... Read more
PATIENT EXPERIENCED A "HOT FLASH' AND TIGHT THROAT AT ITHE 15 MIN MARK, COLD AND CLAMMY FOREHEAD, 121/79 89, 100 % GIVEN COLD WATER TO SIP, REPORTS NO DIFFICULTY SWALLOWING AND IMPROVED TIGHTNESS WITH SIPS. 0935 SIDE EFFECTS RESOLVED DISCHARGED AT 945 TOLD PO'S NOT THROAT TIGHTNESS. PATIENT EDUCATED TO REPORT SIDE EFFECT TO VACINATOR AT SECOND DOSE APPOINTMENT PRIOR TO ADMINISTRATION. PATIENT VERBALIZED UNDERSTANDING OF PATIENT CARE PLAN.
28 2021-04-25 numbness, bell's palsy Bell's Palsy. Feel numbness on the right side of face for about 10 days.
28 2021-04-25 migraine with aura Below symptoms noticeably worse - Vertigo - Migraine visual aura - Tinnitus Onset 4 days after Pfiz... Read more
Below symptoms noticeably worse - Vertigo - Migraine visual aura - Tinnitus Onset 4 days after Pfizer dose # 1. Symptoms still not much improved as of 12 days after vaccination
28 2021-04-26 flushing Patient had flushing/sweating, dizziness, lightheaded, diaphoretic, lips tingling, slight blurred vi... Read more
Patient had flushing/sweating, dizziness, lightheaded, diaphoretic, lips tingling, slight blurred vision, anxious. Given water, juice, graham crackers. Symptoms improved, stable, patient released from vaccination site.
28 2021-04-26 seizure, tremor, unresponsive to stimuli, muscle twitching Systemic: Fainting / Unresponsive-Medium, Systemic: pt had seizure-like twitching, fell off his chai... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: pt had seizure-like twitching, fell off his chair face first. He cut his face.-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Pt told me he gets lightheaded after vaccines. I told him I'd help him get to a chair near vaccination area so I could monitor him. He agreed. I didn't even have time to apply the bandage when he started twiching & basically jumped out of his chair. He twisted 180 degrees and fell on his face. He got cut in at least 2 facial areas. Pharmacist cleaned him up. He never lost consciousness. EMS came and treated him. He refused to go to hospital at first, but eventually they took him.
28 2021-04-27 feeling of body temperature change, flushing Pain on left lower side of stomach around at random times, this is the second day in a row. Feeling ... Read more
Pain on left lower side of stomach around at random times, this is the second day in a row. Feeling exhausted and sore the second day after the vaccine. Feeling hot and flushed and then cold at times Headache
28 2021-04-28 pain in extremity Chills, injection arm ache, back ache, headache - symptoms disappeared overnight but lasted roughly ... Read more
Chills, injection arm ache, back ache, headache - symptoms disappeared overnight but lasted roughly 16 hours or so
28 2021-04-28 pain in extremity Received COVID vaccine (Pfizer) 3 days prior to admission which was followed by subjective fevers an... Read more
Received COVID vaccine (Pfizer) 3 days prior to admission which was followed by subjective fevers and chills x 2 days but no longer endorses this. Had a headache one day prior to admission that resolved with tylenol. Reports that he has hx HTN but home BPs (which he takes infrequently) have been 140s-150s systolic in the past. Has never been on meds for blood pressure. Chest pain was substernal 5/10 lasted 2 hours and believes it relieved with his blood pressure coming down. Does not describe any other alleviating factors. It was nonradiating, just happens for have left arm pain after vaccine that was present prior to chest pain.
28 2021-04-28 seizure PATIENT HAD SEIZURE ABOUT 5 MINUTES AFTER VACCINATION. THE SEIZURE LASTED ABOUT 5 SECONDS.
28 2021-04-28 tenderness A day after the vaccine I noticed pain in my armpit. I looked at my arm and I have roughly a golf b... Read more
A day after the vaccine I noticed pain in my armpit. I looked at my arm and I have roughly a golf ball sized lump in my armpit. It's pretty tender when I touch or move my arm abruptly. From what I've researched it seems like a fairly normal reaction, but I still want to report it. I've taken ibuprofen and tried icing it to help with the swelling.
28 2021-04-29 tenderness Notmal injection. Days later large lumps formed on my under arm and rib cage that appear to be lypno... Read more
Notmal injection. Days later large lumps formed on my under arm and rib cage that appear to be lypnodes or something similar. Painful to the touch and persistent over a few days
28 2021-05-01 feeling hot headache, fever (100 F), chills. Symptoms started at about midnight. The chills lasted for a few ho... Read more
headache, fever (100 F), chills. Symptoms started at about midnight. The chills lasted for a few hours throughout the night but were gone after a few hours (2-6). I took 325 mg of aspirin in the morning at about 10 am. I did not remeasure my temperature, but my head still felt warm. I took 500 mg of acetaminophen 1-3 hours afterwards. The fever went away and I felt normal again by the time I went to bed (11 pm).
28 2021-05-03 discomfort Two lumps above clavicle suspected to be swollen lymph nodes on the left side (same side of vaccine ... Read more
Two lumps above clavicle suspected to be swollen lymph nodes on the left side (same side of vaccine injection). One lump is soft and moveable, and one is pea sized and it is firm and also moveable. Both lumps are painless. Discomfort and tension on the side of the neck where the swollen lymph nodes are. I noticed the lumps about two weeks after the first vaccine dose. The day after the second dose, the lumps swelled a bit more and neck tension increased.
28 2021-05-03 flushing Patient reports dizziness, nausea, flushed and visual changes. Patient reports going running before... Read more
Patient reports dizziness, nausea, flushed and visual changes. Patient reports going running before vaccine and didn't eat or drink. After patient spent some time lying down and drinking some water, patient reports symptoms resolved.
28 2021-05-03 pain in extremity Aside from the expected soreness in the arm and short lived fevers, I started to develop painful swe... Read more
Aside from the expected soreness in the arm and short lived fevers, I started to develop painful swelling and hard lumps in my lymph of the same armpit as my injection site. It was quite painful and broke out into a puss-tipped rash and continued to get worse. It has been over 20 days now and instead of getting better, it has spread to my other armpit now. I went to the local advanced urgent care clinic who ran some bloodwork and said my white cell count is normal and non-indicative of lymphoma, so I was put on prednisone and doxycycline. The medication has done next to nothing and I was told that there was nothing else they could do. The pain in the arm varies per day but there are some days where it is too painful to use my arms at all.
28 2021-05-04 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
28 2021-05-05 feeling hot Post vaccine pt felt warm a light headed. Pt laid down independently and symptoms went away but retu... Read more
Post vaccine pt felt warm a light headed. Pt laid down independently and symptoms went away but returned upon standing up. Pt laid down again until brought to Medical Observation. Vitals obtained and monitors. Water and food provided 1626 LYING BP 125/75 HR 93 Sp02 100% 1631 LYING BP 126/69 HR 93 RR 16 Sp02 98% 1636 LYING BP 128/85 HR 89 RR 14 Sp02 100% 1648 STANDING BP 150/81 HR 94 RR 14 Sp02 98% 1650 STANDING BP 128/74 HR 93 Sp02 99%
28 2021-05-05 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
28 2021-05-05 tingling Patient is a 28 year old male in the observation area presents tingling sensation from right hand th... Read more
Patient is a 28 year old male in the observation area presents tingling sensation from right hand that jumped to left arm then to left leg then resolved after 2-3 minutes. Endorsed had the same No CP, SOB, angioedema, blurry vision, slurry of speech, facial droop. Physical exam unremarkable. Vital signs stable. Neuro intact. Given ED precautions for CP, SOB, angioedema, sudden focal weakness. Sent home stable with resolved symptoms.
28 2021-05-06 cold sweat Cold sweats, nausea, flu symptoms
28 2021-05-06 feeling cold Last weekend on Sunday morning (April 25th), I received my second shot of Pfizer vaccine at 9am. My... Read more
Last weekend on Sunday morning (April 25th), I received my second shot of Pfizer vaccine at 9am. My body started to show some side effects on the evening of Sunday. I felt super cold around 10 pm and at the same time, I had a fever, too. I went to bed early that night (around 10:30 pm) and since I was super cold, I had 3-4 blankets on me when I was on my bed. Suddenly, at 1 am, I woke up due to a very strange noise in my head (a very low-volume noise of knocking on the door every 10 seconds!! I think it was only something in my mind). Since I couldn't sleep because of that low artificial noise, I decided to go to the bathroom at around 1:10 am (My bode was also in lots of pain at that time). When I started to walk, I realized that something is wrong with my body. When I peed and stood up to get back to my bed, I noticed that I'm losing control! Therefore, I hit the bathroom door to wake up my girlfriend, and then I fainted! (I can't remember anything for about 30 seconds here). My girlfriend told me that when I fainted, one of my eyeballs was upward and the other was downward (like zombies!!). She started to freak out and called her mom, but once they started talking, I woke up. My body was soaking wet when I woke up and I was in lots of pain. I asked her to help me to lay down on the ground. After 10 minutes, that my sweats were gone, I started feeling cold and asked her to give me a blanket. I couldn't sleep for about 2-3 hours after I fainted, but I was feeling better (I was much better than the time before fainting). On Monday afternoon, I called the health center and told them my side effects. They strongly recommended visiting ER ASAP since the symptoms that I described were severe side effects of Pfizer. Therefore, I went to ER on Monday (April 26th) to see what?s the issue. Hopefully, after spending 3-4 hours there, and passing some tests, the results did not show anything wrong with my body, but just the side effects of the vaccine.
28 2021-05-07 weakness, inability to speak, tingling Shortness of breath, rapid heartbeat, tiredness and weakness, tingling in the face and extremities, ... Read more
Shortness of breath, rapid heartbeat, tiredness and weakness, tingling in the face and extremities, could not articulate, swelling on the right side of the face.
28 2021-05-08 cold sweat, numbness Immediately after the patient received the vaccination he stated that his arm felt numb. This seemed... Read more
Immediately after the patient received the vaccination he stated that his arm felt numb. This seemed to concern him greatly although I reassured him that this reaction had been reported to me on other occasions and it was transient. I checked his blood pressure and pulse, both of which were normal, and he waited for about 20 minutes before returning to work where he received the shot. He returned to the pharmacy approximately 15 minutes later and stated that he felt dizzy, nauseous, and had blurry vision. His forehead felt cold and clammy to the touch and he was sweating. I had him sit, and checked his pulse again (still normal). He stated that his chest felt "cold and tired" but he was not having difficulty breathing. After observing him for some minutes I gave him a 50mg dose of Benadryl in case the reaction was allergic in nature. I observed him for at least 15 more minutes were he seemed calm and was able to speak on his cellphone to family so they could come and pick him up. In my opinion he seemed improved by the time he left but I counseled him to seek medical attention if his adverse feeling worsened. The patient was able to walk out of the Walmart without assistance. I called him at home around 5:20 pm and he sounded very sleepy but he had not yet had to seek further medical attention.
28 2021-05-09 cold sweat 5 min after receiving vaccine felt clammy and nauseous vomited small amt undigested food brought b... Read more
5 min after receiving vaccine felt clammy and nauseous vomited small amt undigested food brought back to OBS 1 via wheelchair upon arriving to OBS area pt pale in color transferred self without difficulty to stretcher, VS as noted pt feeling better once laying on stretcher, awake and alert pt states has anxiety related to needles pt given snack and water, tolerated well. denies further symptoms color improved. pt repositioned self to dangle at side of bed then standing with no further issues. discharged to exit. VS 0925 hr 66 po 100 bp 134/82 0930 hr 71 po 99 bp 138/73 0935 dangle hr 63 po98 bp 121/74 0940 standing hr 79 po 98bp 124/76
28 2021-05-09 pain in extremity woke up 3 AM Friday was sore, ache, chills, the small blister noted that Friday evening injection si... Read more
woke up 3 AM Friday was sore, ache, chills, the small blister noted that Friday evening injection site bump small blemish- scratched and it "popped" similar to a sunburn, it's flat now but a little itchy. Sore arm, body ache, chills - this is resolved 5/4-Placed follow-up call, pt reports that on the left arm the bump went down and not as raised as before, and it is not spreading and not painful. Pt reports took Tylenol ES and drank a lot of powerade and that helped. Pfizer 1st dose 4/8/2021 @ 1630 LOT#: EW0153. Recommend that if it gets itchy or red an apply topical otc anti-itch cream as needed.
28 2021-05-10 bell's palsy Bells palsy on the right
28 2021-05-10 migraine Within 15 minutes, light headed and slight nausea, deeveloping small rash on right arm Within 60 min... Read more
Within 15 minutes, light headed and slight nausea, deeveloping small rash on right arm Within 60 minutes, migraine, nausea, slight chest pain, HBP, fever Within 8 hours, migraines, nausea, body aches, fatigue, fever With 24 hours, migraines, nausea, body aches, fatigue,on/off fever
28 2021-05-10 tingling Dizzines, nausea, tingling in fingers, vasovagal reaction. Pt reports that has needle phobia and has... Read more
Dizzines, nausea, tingling in fingers, vasovagal reaction. Pt reports that has needle phobia and has not had blood draw or any vaccination for a long time. Pt reported nausea, but no vomiting, feeling dizzy, and tingling of fingers. Pt was transported via wheelchair and transferred to bed. Pt reported doing well after 5 minutes, water, crackers and juice was given. Pt reported doing well and was asymptomatic. Pt was observed for a period 20 minutes. BP: 110/69, HR: 62, R: 16, O2 sat: 98 to 100% room air. Pt was discharged in stable condition.
28 2021-05-13 speech disorder, paralysis, numbness, weakness, burning sensation, coordination abnormal he had an episode which he states is similar to a TIA (transient ischemic attack); Reports experienc... Read more
he had an episode which he states is similar to a TIA (transient ischemic attack); Reports experiencing something similar last may except for 'the paralysis'.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; States he felt as though his knee had a tear in it- it felt it was on fire; tightness in left knee; shortness of breath; feeling foggy; headache; balance issue; coordination off; having a hard time to get a sentence out (felt like his motor skills were affected); having a hard time to get a sentence out (felt like his motor skills were affected); confusion; blurred vision; impending sense of doom; post fatigue; his energy doesnt feel up to par; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 at 28 years old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that on 19Apr, he had the first shot of pfizer covid vaccine. This past sunday (25Apr2021), he had an episode which he stated was similar to a TIA (transient ischemic attack). Reported numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side. Stated he felt as though his knee had a tear in it- it felt it was on fire; he experienced burning and tightness in left knee. He also reported having shortness of breath, headache, feeling foggy, balance issue, coordination off, having a hard time to get a sentence out (felt like his motor skills were affected), confusion, blurred vision and an impending sense of doom. Stated this episode persisted for 15 min and then it resolved. Currently he was experiencing a 'post fatigue' and his energy didn't feel up to par. Reported experiencing something similar last may except for 'the paralysis'. Had not followed up with his provider. Patient was scheduled for second shot of Pfizer covid vaccine on 10May, he was asking for information if he decided to delay his second shot past may 10th. He was asking for information on getting the second shot given his recent experience possibly related to the vaccine shot. Was not sure if he should get the second shot. He was asking about side effects for the second shot- if it would be worse. Asking if there were any reports of blood clots with Pfizer covid vaccine. The outcome of the events 'post fatigue' and "his energy didn't feel up to par" was unknown, of other events was recovered on 25Apr2021. Information about lot/batch number has been requested.
28 2021-05-16 electric shock sensation, pain in extremity, burning sensation, nerve pain, tingling Cognitive -- severe symptoms began ~3 days after Pfizer 2nd dose. Extreme disorientation and confus... Read more
Cognitive -- severe symptoms began ~3 days after Pfizer 2nd dose. Extreme disorientation and confusion (transient), memory loss (longterm), extreme lethargy - unable to move, intermittant psychosis (mild, esp. when going to sleep), and anxiety (transient but very extreme, unlike anything I've felt before, not improved by diazepam) (continued for 10 days then began to improve dramatically followed by alternating relapse on a daily basis for 4 weeks, up to present -- dramatically and stably improved by steroid treatment, returned after discontinuing) Nerve pain -- began ~1 week after Pfizer second dose. -- tingling, burning throughout extremities, especially fingertips, toes, hips; transient (usually 5 seconds or less). Progressively became more frequent (20+ / day), longer lasting (up to 20 seconds) and more severe (like stabbing or electric shock). Gradually resolved after course of dexamethasone beginning 3 weeks after vaccination. Sharp inner ear pain -- (both ears) began ~1 week after Pfizer second dose. Rare events (~5x / day), very transient (1-2 seconds) but extremely painful. Continues up to present, (4 weeks after Pfizer second dose). Also constant popping of both ears beginning week 2 to present, feels like fluid inside. Adenopathy -- On 4/28/21 noticed massive swelling on left pectoral muscle (contralateral to vaccine injection site), diagnosed as lymphadenopathy, moderately painful. Continued to get worse for 1 week, began dexamethasone on 5/7/21. Dramatically improved, however swelling returned after discontinuing steroid and spread to all lymph nodes, including neck and others. Became extremely painful on 5/14/21, unable to walk due to swelling in inguinal lymph nodes. Again dramatically improved after steroid injection on 5/16/21.
28 2021-05-17 bell's palsy Bell's Palsy
28 2021-05-18 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Chills roughly 12 hours after administration. Resolved by the n... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Chills roughly 12 hours after administration. Resolved by the next morning Headache began 15May21 resolved 16May21 Left Hip pain from 16May21-17May21 Pain in outer left thigh 19May21 - ongoing (no redness or swelling) Fatigue: 14May-15May21
28 2021-05-18 tingling Patient reported tingling sensations all over body, heavy sweating, and *feeling like fainting* 5 mi... Read more
Patient reported tingling sensations all over body, heavy sweating, and *feeling like fainting* 5 minutes after injection during observation period. One dose of epipen was administered and patient immediately started feeling better after 2 minutes
28 2021-05-19 facial paralysis Patient reports approximately 1 week after vaccination noticing tingling sensation to right upper li... Read more
Patient reports approximately 1 week after vaccination noticing tingling sensation to right upper lip. This was mild and persisted for a few days. He noticed a few days later that when he went to drink water it drippled down his right cheek, as if he could not close his lips completely on the right side. This continued for 1 day, then improved and has now resolved. Never had any other facial paralysis and was able to completely close his right eye. He did not seek medical attention for this. He went for his follow up vaccination dose and was turned away when he brought up these symptoms, and made appointment with myself at his PCP office.
28 2021-05-20 weakness After shot. I was sitting down for the advised 15 minutes. I got up to pass the time and look at an ... Read more
After shot. I was sitting down for the advised 15 minutes. I got up to pass the time and look at an aisle in the store. All of a sudden everything went white and my head got light headed and I had to go down on my knees, I was then weak and advised to stay seated. Eventually it passed but I am shaken up.
28 2021-05-21 cold sweat PT ADMINISTERED 1ST DOSE OF COVID PFIZER VACCINE. WAS TOLD TO SIT FOR 15 MINUTES. AFTER ABOUT 5 MINU... Read more
PT ADMINISTERED 1ST DOSE OF COVID PFIZER VACCINE. WAS TOLD TO SIT FOR 15 MINUTES. AFTER ABOUT 5 MINUTES, WIFE NOTIFIED PHARMACY STAFF OF PT PASSED OUT IN CHAIR (SLUMPED OVER). AFTER PHARMACIST ATTEMPTED TO GET ATTENTION, HE REGAINED CONSCIOUS BUT WAS CLAMMY AND SWEATY. PT ASKED FOR A GLASS OF WATER. AFTER A FEW MINUTES, HE STATED HIS CHEST WAS HEAVY AND VISION BLURRY. 1 DOSE OF AN ADULT EPIPEN WAS ADMINISTERED WITH PT CONSENT. HE STATED HE FELT BETTER. WIFE REQUESTED EMS BE CONTACTED. EMS DISPATCHED AND PT LEFT PHARMACY CONSCIOUS IN A STRETCHER.
28 2021-05-21 feeling hot Patient observed at 1442 sliding down in his observation chair. Observation nurse helped lower patie... Read more
Patient observed at 1442 sliding down in his observation chair. Observation nurse helped lower patient to the floor. Patient had a syncopal episode for a few seconds. Patient woke up, assisted into wheelchair, and taken to private room for further assessment. Full set of vitals obtained as follows: O2 sat 99% RA, HR 66, BP 138/80, RR 18. Patient stated he was feeling fine and that he previously was outside today and was very hot before receiving his vaccine. Patient also stated he had a historyof syncopal episodes from being over heated. Monitored pt for another 10 minutes and took another set of vitals at 1452 as follows: O2 sat 99% RA, HR 83, BP 135/85, RR 17. Assessed patient vitals 10 minutes later at 1502...
28 2021-05-23 nerve pain, pain in extremity On May 13 (3 Weeks after first covid vaccine shot), I started to feel skin pain on the area above ri... Read more
On May 13 (3 Weeks after first covid vaccine shot), I started to feel skin pain on the area above right kneecap. Then I felt nerve pain on the same side of leg. May 14 I couldn't sit down as I felt occasional lumbar pain. I even went to orthopedics and they said no trouble found. Skin pain spread through the whole body. May 15 I had second shot of pfizer, still back pain and thigh pain. Skin pain spread through whole body. May 16 I saw red spots begin to surface on the thigh. Skin pain spread through whole body. May 17 red spot became bigger I thought it was rash, pain persists. May 18 the red spots looks out of control, I scheduled the next available appointment for primary care (2days later!) May 19 Just bigger red spots every time I take off my pants. May 20 black bubbles appeared in the morning, and I got to finally go to appointment at noon, diagnosed as shingles.
28 2021-05-23 unresponsive to stimuli Syncopal episode with fall from chair. Unresponsive approx 30 seconds. Pt was GCS 15 within 60 seco... Read more
Syncopal episode with fall from chair. Unresponsive approx 30 seconds. Pt was GCS 15 within 60 seconds after syncope. EMS was called because the pt hit his head on the ground but did not sustain any life threatening or injuries. No signs of trauma to note. Pt was AOx4 and GCS 15 by the time he was dismissed from the clinic.
28 2021-05-25 pain in extremity Chest pain, dizzy, light headed, leg and arm pain, short of breath, tired, spaced out mentally/unabl... Read more
Chest pain, dizzy, light headed, leg and arm pain, short of breath, tired, spaced out mentally/unable to focus. No treatment at this time.
28 2021-05-30 unresponsive to stimuli, flushing Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
28 2021-06-01 feeling hot Patient complained of feeling warm all over, sweating, feeling shaky. Denies shortness of breath, fa... Read more
Patient complained of feeling warm all over, sweating, feeling shaky. Denies shortness of breath, facial swelling or itching. Patient transferred to gurney from wheelchair. Patient put in Trendelenburg position and legs elevated, cold compress to forehead, ice pack to back of neck. After a few minutes, patient stated he "feels much better". Blood pressure 154/88 at first, 8 minutes later 138/81 (lying). Tried sitting. Apple juice given. Patient vomited x 1. After a few minutes he felt okay sitting with feet dangling. Tried ambulating. Denied dizziness. Patient wanted to go home. Discharged with mother.
28 2021-06-01 pain in extremity Fever; Headache; sore arm; very tired; This is a spontaneous report from a contactable consumer (pat... Read more
Fever; Headache; sore arm; very tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0150) in the left arm, on 24Apr2021, at 12:15 PM, at single dose, 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 unknown. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. On 02May2021, at 06:00 AM, the patient experienced fever, headache, sore arm and he was very tired. No treatment was received. Post the vaccination, the patient has not been tested for COVID-19. The patient did not recover from the events at time of this report. The case was assessed as non-serious. Then, on 15May2021, at 09:45 AM, the patient received the second dose of BNT162B2 (COMIRNATY, Lot. EW0179) in the left arm, at single dose, for COVID-19 immunisation. No follow-up attempts are needed. No further information is expected.
28 2021-06-01 tremor Patient reports having tremors lasting 1 hour straight which were on and off for the first day and a... Read more
Patient reports having tremors lasting 1 hour straight which were on and off for the first day and a half. Had a gradient body temperature from warm to cold from lateral side to lateral side of body.
28 2021-06-02 flushing VIIS ID: 41412; Pfizer COVID-19 Vaccine Vaccine Lot Number: Ew0178 2nd dose; vagal faint after vacc... Read more
VIIS ID: 41412; Pfizer COVID-19 Vaccine Vaccine Lot Number: Ew0178 2nd dose; vagal faint after vaccine#2 pfizer, hx of anxiety and vagal reaction, + 10-15 secs LOC no fall, no trauma, no neck pain/stiffness. increase oral hydration. Apprehension, flushing and/or skin edema, moderate ETOH night before. faints with vaccinations and tattoos. 540pm 140/88, P-70, R-20 POX 99%; 5:50 147/80, p-66, r-20, Pox-99%. Pt d/c home-friend driving him home.
28 2021-06-02 numbness, tingling Tingling, numbness in left arm and heart area; shortness of breath; abnormal heartbeat all on a dail... Read more
Tingling, numbness in left arm and heart area; shortness of breath; abnormal heartbeat all on a daily basis since about a week or 2 after the second vaccination shot.
28 2021-06-02 muscle twitching Patient reports twitching in left arm throughout day at vaccine site in tricep each day since first ... Read more
Patient reports twitching in left arm throughout day at vaccine site in tricep each day since first covid Pfizer vaccine. Patient reports twitching is getting better.
28 2021-06-02 pain in extremity Patient received the Jansen vaccine in April then came to our facility informing us that he had not ... Read more
Patient received the Jansen vaccine in April then came to our facility informing us that he had not been vaccinated and we went ahead and administered the Pfizer vaccine serues
28 2021-06-02 unresponsive to stimuli 28 year old male presented for initial dose of Phizer-BioNtech at 1100 AM on 6/3/21. Pre-assessment... Read more
28 year old male presented for initial dose of Phizer-BioNtech at 1100 AM on 6/3/21. Pre-assessment form was filled out and reviewed with nursing student administering the vaccine. The client stated no known allergies to medications, food, venom, or environmental elements. He also stated no allergic reactions to previous vaccines. The client also stated that he had no known health issues. After administration the patient stated he was dizzy and then immediately became unresponsive, diaphoretic, eyes rolled back, and head hyperextended. Family was present and we asked if he had any seizure history and his family declined. At this time the patient and family informed us that after vaccines in the past he does faint but didn't inform staff before this vaccine was administered. The patient remained unresponsive for 45 seconds. Then his feet were elevated and he asked to lay down. At 11:11 AM his HR was 60 and O2 was 97% on pulse oximetry. He felt hot and was still diaphoretic and felt very fatigued. Once he started feeling better we sat him back up and his HR was 89 and O2 was 99%. We gave him 2 bottles of water and crackers. He remained in our care for 45 minutes. He then waited an additional 30 minutes in the post vaccine area. His family stated they were going to drive him home and get some food. The patient is expected to return June 24, 2021 for his second dose of the Phizer vaccine. We provided additional discharge instructions
28 2021-06-03 inability to speak 28 yold male previously healthy who presented with recurrent loss of speech and motor function witho... Read more
28 yold male previously healthy who presented with recurrent loss of speech and motor function without loss of consciousness beginning 5/8/2021. Pt received his 2nd Pfizer COVID MRNA vaccination on 5/7/2021
28 2021-06-03 numbness, tingling It was the patients first COVID-19 Pfizer vaccine dose and he was sitting in the waiting room after ... Read more
It was the patients first COVID-19 Pfizer vaccine dose and he was sitting in the waiting room after his vaccination and came to get me to tell me that he did not feel well. He was sweating and then proceeded to vomit. We had him sit in the other exam room and gave him some water. After that he started saying his arms were tingling and going numb, when that happened I discussed with him calling EMS and instructed the PCT to call EMS. When EMS came the pt said he was feeling better and signed a refusal to go with them to the ER. The pt had a friend who was in the store with him that was going to drive him home. He was able to sit for about 30 minuets when he stated that he was feeling better and was wanting to go home. PCT walked him to the car. He was instructed that if at any time he started having symptoms again that he needed to go to the ER.
28 2021-06-06 weakness Pt was brought to the triage area with c/o chest tightness, weakness, and mild SOB. No CP, non-radia... Read more
Pt was brought to the triage area with c/o chest tightness, weakness, and mild SOB. No CP, non-radiating. VS taken: (1:47 PM) BP 141/97, HR 108, Resp 20, O2 sat 100 on R; (1:52 PM) BP 147/98, HR 106, Resp 18, O2 sat 100% on RA. Pt no in apparent distress, speaks in full sentences, mentating well. Nurse manager and attending MD at triage area to monitor pt. Advised pt to go to ED but pt refused. Pt stated that he will be fine and just need to go home and rest. ED precautions discussed. Pt verbalized understanding and signed AMA form. Pt left the triage area with no assistance, ambulating well, with steady gait.
28 2021-06-06 pain in extremity Patient presented for his second dose and noted lingering arm pain and difficulty raising left arm t... Read more
Patient presented for his second dose and noted lingering arm pain and difficulty raising left arm to shoulder height.
28 2021-06-06 tremor Per LVN patient was nervous and shaking some prior to the vaccine. LVN offered patient to decline or... Read more
Per LVN patient was nervous and shaking some prior to the vaccine. LVN offered patient to decline or return another date. Patient reported he has to get it for the University. Immediately after the vaccine which was given at 0950, patient reported nausea. LVN notified RN. 0958 Patient sitting up in chair with an emesis bucket. Patient is pale and has light tremors, and reports nausea. Vital sigs taken Pulse 91, respirations 20, blood pressure 91/54, and 02 sat 100%. Patient reports he is thirsty. Reports he ate a bagel and had coffee this morning. Gave patient sips of water. Had patient take a few deep breaths. 1003 Assisted to gurney. Vital signs rechecked and ice pack applied to back of head and neck. Pulse 65, blood pressure 110/74, 02 100%. Patient reports he is feeling better. Patient transported with LVN and RN via gurney to nurse treatment room per protocol. Report given to LVN ad RN. Patient is stable.
28 2021-06-07 pain in extremity, feeling hot arm sore; got a little warm; got a little headache; This is a spontaneous report from a contactable ... Read more
arm sore; got a little warm; got a little headache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration in arm left, on 22Apr2021 (Lot Number: EW0171) and on 14May2021 (Lot Number: EW0182), (at the age of 28-years-old) respectively, both as single doses for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that his second shot was scheduled at the location where he got his first dose, but he could not go to that location, so he rescheduled the second dose at different location. Further he added that, the guy at the second location did not know he was going to get the second shot hence, the patient was afraid if he might get the first shot twice and wanted to know if he should be concerned about this. On an unspecified date in May2021, the patient had arm sore, got a little warm and headache. The patient experienced the same side effects as he did with the first dose and stated that the symptoms started the next day after each dose and lasted about two days (exact dates were unknown). The outcome of the events was unknown. Additional information is requested.
28 2021-06-08 tingling Patient felt tingling in the arm after administration & informed vaccinator that he felt like he was... Read more
Patient felt tingling in the arm after administration & informed vaccinator that he felt like he was going to pass out. He started to lose consciousness shortly after & EMS was called to clear before he was allowed to leave. Patient was out for only a couple of seconds before regaining consciousness. He remembered feeling dizzy & like he was falling during the episode.
28 2021-06-10 flushing, unresponsive to stimuli, weakness Patient started perspiring profusely, became weak and flush, and appeared to pass out and become unr... Read more
Patient started perspiring profusely, became weak and flush, and appeared to pass out and become unresponsive while sitting in the chair. Patient was given water and ice to cool down while 911 was contacted. After a few minutes, the patient returned to normal mental status and was ready to leave. Patient refused care when arrived and he was released from the site.
28 2021-06-10 seizure R56.9 - Unspecified convulsions SEIZURES
28 2021-06-10 tremor His eyes rolled in the back of his head , became stiff , and was shaking. It lasted approximately 1 ... Read more
His eyes rolled in the back of his head , became stiff , and was shaking. It lasted approximately 1 minute. EMS was called to check out.
28 2021-06-11 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Additional Details: Pt fainted about 8 minutes after vaccine. He had been given cold water and candy. Blood pressure was normal, but he was sweating and continued dizzy. He admitted to vaping earlier. He wanted us to call 911. 911 said he was hyperventilating and said it was from anxiety. He was checked out and fine. Called him later and he was fine.
28 2021-06-15 pain in extremity Developed left lower leg pain the follow day after receiving his second COVID vaccine. Still persis... Read more
Developed left lower leg pain the follow day after receiving his second COVID vaccine. Still persistent to date.
28 2021-06-16 numbness, face paralysis Patient is a 28 year old male who developed left side facial weakness and numbness a day after his s... Read more
Patient is a 28 year old male who developed left side facial weakness and numbness a day after his second COVID-19 vaccination. His physical exam was notable for left sided forehead and mouth weakness, with loss of left side blink although forced eye closure intact on the left side.
28 2021-06-16 migraine Fever with sweats and chills, migraine. Happened overnight, about 12 hours of intensity and 12 hours... Read more
Fever with sweats and chills, migraine. Happened overnight, about 12 hours of intensity and 12 hours lingering.
28 2021-06-18 numbness, tingling right shoulder felt numb/ the numbness spread to the rest of the right arm, hand, shoulder, side of ... Read more
right shoulder felt numb/ the numbness spread to the rest of the right arm, hand, shoulder, side of the neck, and side of the face.; I feel intense tingling sensations throughout the day; lose of control of my right arm and leg; dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient). This 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 08Apr2021 07:00 AM (Lot Number: EP7533) at the age of 28-year-old as single dose for covid-19 immunisation. The patient medical history was none. No known allergies or other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the evening of the first day after getting the vaccine, on 08Apr2021 at 04:00 PM, patient right shoulder felt numb. Over the course of the next few days, the numbness spread to the rest of the right arm, hand, shoulder, side of the neck, and side of the face. At this point, he went to the ER and then they admitted him to hospital for 3 days, gave him steroids, did an MRI of his neck and a CT of head. After discharged, in Apr2021, patient felt intense tingling sensations throughout the day making him dizzy, nauseous, and loss of control of his right arm and leg. Patient has had regular visits with the recommended neurologist where they did an EKG test, and patient is now waiting on a lumbar puncture test. Event numbness resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for three days. Since the vaccination, the patient had not been tested for COVID-19. Treatment received for the adverse event numbness as steroids. Outcome of the events was not recovered.
28 2021-06-19 tingling Within a few minutes after receiving my first COVID vaccine I started feeling lightheaded/nausea and... Read more
Within a few minutes after receiving my first COVID vaccine I started feeling lightheaded/nausea and then lost consciousness. My wife was with me during this time and stated that I lost consciousness for about a minute. My wife stated that my eyes rolled back in my head, my back arched, and I became rigid. Upon waking up my ears were muffled and my wife stated my lips were blue and my face/arms/legs were very pale in color. Both of my legs and both of my hands were also tingling upon waking up. 911 was called by my wife.
28 2021-06-21 pain in extremity, weakness Hand pain, no appetite, weak, fever, severe headaches.
28 2021-06-21 seizure Patient has seizure disorder and was well controlled for 1.5 years prior to 1st Pfizer vaccine. Pat... Read more
Patient has seizure disorder and was well controlled for 1.5 years prior to 1st Pfizer vaccine. Patient experienced a seizure within 8 hours after receiving dose. No report of fever.
28 2021-06-23 feeling cold Patient got really dizzy and was sweating profusely about 3 minutes after receiving his vaccine. Th... Read more
Patient got really dizzy and was sweating profusely about 3 minutes after receiving his vaccine. This lasted about 15 minutes. He then felt cold and had the chills once he stopped sweating. He was soaked with sweat. I made him stay for another 15 minutes to observe him. He felt normal once he left.
28 2021-06-24 tingling Lightheaded(mild); Fatigue(mild); muscle pain at injection site(moderate); tingling in fingertips(mi... Read more
Lightheaded(mild); Fatigue(mild); muscle pain at injection site(moderate); tingling in fingertips(mild); This is a spontaneous report from a contactable consumer or other non HCP (Patient, reported for self) A 28-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:15 as single dose for covid-19 immunization. (vaccination Facility: Other). Medical history was not reported. The patient concomitant medications were not reported. patient did not took any other vaccine in four weeks. Patient did not experience COVID prior to vaccination. No known allergies. Patient had no known allergies. Other medical history: None. On 05Feb2021 at 10:45 AM patient experienced Lightheaded(mild), Fatigue(mild) muscle pain at injection site(moderate) and tingling in fingertips(mild). Patient did not receive any treatment for the adverse events. Patient was not tested for COVID post vaccination. Outcome for the events was reported as Recovering. Follow-up attempts are completed. No further information is expected.
28 2021-06-27 tingling 10 TO 15 MINUTES AFTER RECIEVING 1ST DOSE OF PFIZER COVID VACCINE PATIENT STATED HIS ARM FELT LIKE ... Read more
10 TO 15 MINUTES AFTER RECIEVING 1ST DOSE OF PFIZER COVID VACCINE PATIENT STATED HIS ARM FELT LIKE IT WAS TINGLING AND IT RADIATED TO HIS CHEST. HE STATES HE DID NOT HAVE CHEST PAIN BUT IT FELT STRANGE. PATIENT STATED HE HAD NOT HAD ANY PO FLUIDS SINCE 4:30 THAT MORNING. HE WAS GIVEN WATER TO DRINK AND OBSERVED. PATIENT'S SYMPTOMS WERE RESOLVED BEFORE LEAVING FACILITY. FOLLOW UP CALL ON 6/28/21 PATIENT STATED HE CONTINUED TO BE ASYMPTOMATIC OVER THE WEEKEND AND WAS BACK AT WORK TODAY.
28 2021-06-29 migraine, tremor The morning after the first inoculation I woke up at 7:30 am with severe chest pain . It would hurt ... Read more
The morning after the first inoculation I woke up at 7:30 am with severe chest pain . It would hurt to inhale and exhale and I was short of breath, possibly due to the not being able to inhale without pain. Breathing was shallow as to not cause pain. I administered hydrocodone 15 mg PO q6h for pain. I told my pulmonologist who stated it sounded like pleuritis. He stated I should go to the hospital if the pain comes back . I admit I did not follow this order as I felt the pain med resolved it and did not want to go to an ER if it wasn?t critical. The chest pain lasted 96 hours and then resolved . The pain was severe enough to wake me from my sleep multiple times. That was the only AE associated with the first shot . The second shot had many more side effects , Severe nausea , emesis , diarrhea , migraine headache , high fever , shaking , and sinus discharge. The chest pain also came back and I did the same regiment of pain meds to treat the severe pain. These side effects lasted 7 days and then resolved .
28 2021-06-30 pain in extremity Sore arm, fever of 100.7.
28 2021-06-30 tingling, numbness, weakness I started having intermittent numbness, tingling, pain and weakness in my left arm down to my hand a... Read more
I started having intermittent numbness, tingling, pain and weakness in my left arm down to my hand about a week after my second Pfizer Covid vaccination. Over several months it progressively was getting worse. I am a nurse in a hospital and after speaking with several colleagues (other nurses and doctors) about what was going on, I went to my PCP. After seeing my PCP, I was referred to a Hand to Shoulder Center. The doctor declared it as cubital tunnel syndrome in which I had an Ulnar Nerve Release Surgery on June 8th. Approximately a week and a half to two weeks after the surgery I started noticing intermittent numbness and tingling to the left side of my lips and left side of my face. Until I started having issues with my face, I didn't even consider the possible correlation with my problems and the COVID vaccines. It it just ironic that I received both vaccines in my left arm and I am having issues with my left arm and the left side of my face. I am still having numbness, tingling and some weakness to my left arm as well as the intermittent numbness and tingling to the left side of my face. Now I was advised by the surgeon that it could take up to a couple of months for my issues with my arm to resolve but when I contacted my PCP regarding an update on my arm as well as to inform her about the concerns with my face, and questioning the possible correlation with the COVID vaccines, she advised me to file a report through VAERS.
28 2021-07-05 tingling lost consciousness; Lightheadedness; Nausea; She stated that my eyes rolled to the back of my head, ... Read more
lost consciousness; Lightheadedness; Nausea; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; Face/arms/legs were pale in color; My lips were blue; My hearing was muffled; Tingling in both of my legs and hands; Mouth was also extremely dry; This is a spontaneous report received from a contactable consumer or other non hcp. A 28-year-old male patient received bnt162b2 (COMINARTY, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in arm left on 19Jun2021 17:15 as dose 1, single for covid-19 immunization. Medical history included cat hair allergy. Concomitant medications included probiotics (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ascorbic acid (VIT C) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ergocalciferol (VIT D) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. 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 not has been tested for covid-19 since the vaccination. On 19Jun2021 17:15, the patient experienced lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. Therapeutic measures were taken as a result of lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. The outcome of the events was recovering. Information on the lot/batch has been requested.
28 2021-07-07 difficulty speaking Lip swelling and altered voice.
28 2021-07-08 pain in extremity on 7/8/21 , patient noticed soreness in his right arm when he moved his arm in a certain direction o... Read more
on 7/8/21 , patient noticed soreness in his right arm when he moved his arm in a certain direction or position. he stated after vaccine administration on 6/18/21 his arm was sore for 2 days (he stated he experienced average soreness like with any vaccine). Soreness went away completely and had no complaints, but noticed soreness again on 7/8/21 ,around area of injection site on and also sometimes when lifting or rotating arm. He stated he did lift some boxes/totes recently at home and it's possible the soreness could be from that; however, the soreness seems to be in similar area where he received the vaccine 3 weeks ago.
28 2021-07-09 pain in extremity, numbness Heart inflammation, shortness of breath, numbness of left arm, sharp pains in left arm, tightness in... Read more
Heart inflammation, shortness of breath, numbness of left arm, sharp pains in left arm, tightness in chest.
28 2021-07-12 numbness dizziness, sweating, headache, numbness in arms. given 25mg diphenhydramine liquid and water. he d... Read more
dizziness, sweating, headache, numbness in arms. given 25mg diphenhydramine liquid and water. he did not pass out but felt as if he might. he rested in the waiting area until he felt he could leave safely on his own (about 30 minutes).
28 2021-07-14 weakness, migraine sore throat, body aches, weakness, nausea, headache/migraine
28 2021-07-14 feeling hot PATIENT GOT HIS VACCINE AND THEN WATCHED HIS GIRLFRIEND GET HER SHOT, PATIENT STATED HE SAW ME WITH ... Read more
PATIENT GOT HIS VACCINE AND THEN WATCHED HIS GIRLFRIEND GET HER SHOT, PATIENT STATED HE SAW ME WITH THE NEEDLE AND GIVE IT TO HER AND THEN HE GOT SICK FEELING. PATIENT SAT ON FLOOR AND GOT HOT AND TURNED A GREENISH COLOR BEFORE PASSING OUT, PATIENT WAS IN AND OUT FOR ABOUT 2 MINUTES. PATIENT CAME TO AND JOKED ABOUT IT AND SAID THIS HAS HAPPENED BEFORE. PATIENT WANTED TO WALK OFF AND LEAVE, WE HAD HIM SET DOWN AND HIS GIRLFRIEND WENT TO GET WATER AND A SNACK FOR HIM. BEFORE SHE RETURNED HE FAINTED AGAIN AND I HELD HIM UP IN THE CHAIR. HE CAME TO AND STARTED FEELING BETTER. EMS ARRIVED AND CHECKED HIM OUT, PATIENT WAS TAKEN TO AMBULANCE TO BE CHECKED OUT MORE. GIRLFRIEND SAID THEY WOULD RELEASE HIM AFTER WATCHING HIM FOR 30 MINUTES.
28 2021-07-17 feeling of insects crawling on skin Itching.; Random red rash appears on numerous parts of the body; feel headcrawling; This is a spon... Read more
Itching.; Random red rash appears on numerous parts of the body; feel headcrawling; This is a spontaneous report from contactable healthcare professional. A 28-year-old male patient received the second dose BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3249) via an unspecified route of administration in the left arm on 12Jan2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had allergies to medications, food, or other products. 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 medications 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 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 23Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 12Jan2021 the patient experienced itching, red rash and crawling sensation. The patient had itching, a random red rash appeared on numerous parts of the body one month after receiving the second dose of the vaccine. The patient also felt head crawling. The event resulted in a doctor or other healthcare professional office/clinic visit. On an unknown date, post-vaccination, the patient underwent a COVID-19 virus test (nasal swab test) and resulted negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events itching, red rash and crawling sensation were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
28 2021-07-17 tingling Patient developed paresthesia of the left arm; Patient developed paresthesia of the left arm and lef... Read more
Patient developed paresthesia of the left arm; Patient developed paresthesia of the left arm and left side of face.; This is a spontaneous report received from a contactable healthcare professional, the physician. A 28-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left deltoid on 26Mar2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included herniated disc of lumbosacral spine. It was unknown if the patient had any allergies to food, medications, or other products. It was unknown if the patient received any medication within two weeks prior to the COVID-19 vaccine. It was unknown if the patient received 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 vaccination, the patient had not been tested for COVID-19. On 28Mar2021, the patient experienced paraesthesia of the left arm and left side of face and neg (negative) weakness was reported. The adverse events resulted in a visit to the doctor's or other healthcare professional office/clinic visit. The clinical outcome of the events paraesthesia of the left arm, left side of face was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
28 2021-07-18 weakness Intermittent dizziness, palptiations, and feeling lightheaded since administration. Feel much better... Read more
Intermittent dizziness, palptiations, and feeling lightheaded since administration. Feel much better but still feels weak. Had similar episode today (4/20/2021) around 3pm with accompanied by 3 episodes of diarrhea. Seen on 4/10/2021.
28 2021-07-18 feeling hot On June 25th, 2021 at around 4 A.M. I started feeling itchiness and warmth on my face, neck and arms... Read more
On June 25th, 2021 at around 4 A.M. I started feeling itchiness and warmth on my face, neck and arms. Shortly after I noticed red spots on my face, neck, elbows, and hands. Some of the red spots on my face and elbows were raised bumps that were itchy and other red spots were not raised or itchy. On the same day around 10 A.M., the spots on my face faded but others appeared around my knees that were warm to the touch and were raised and itchy. I took allergy medicine (Zyrtec) and applied anti-itch cream (Gold Bond) to the spots which helped with the itchiness and raised bumps but the red spots remained. The following day some of the spots faded on my neck and elbows but some had appeared on my legs, feet and chest. I continued taking the allergy medicine and cream until they completely faded away on like the 4th day, June 28th, 2021.
28 2021-07-21 pain in extremity, seizure First day had sore arm Second day-4th day after injection I could barely life my arm at all. After t... Read more
First day had sore arm Second day-4th day after injection I could barely life my arm at all. After the first dose 7 days later I had a medical episode in my sleep that drs are trying to say was seziure.I have absolutely no family history of epilepsy,no major brain trauma in my life and was in perfect health prior to shot. Prior to the shot I didn't feel sick,I didn't have any kind of medical issues whatsoever.
28 2021-07-21 unresponsive to stimuli The patient was given the first dose of Pfizer COVID-19 vaccine and was instructed to wait in the wa... Read more
The patient was given the first dose of Pfizer COVID-19 vaccine and was instructed to wait in the waiting area for 15 minutes. After waiting for about 15 minutes, he tried to exit the waiting area, but ended up collapsing. When I went out to examine him, his eyes were open and he was breathing normally, but he was not immediately responsive. I had to ask him if he was OK several times before I was able to get an answer. He appeared to be disoriented, but otherwise appeared fine. My technician helped him to a chair. He was coming in and out of non-responsive/limp state several times before he asked us for a glass of water. I had contacted 911. They came in and examined him. One of the paramedics told me that he appeared to be fine, but they were going to take him to ER. The patient walked to the stretcher outside the pharmacy.
28 2021-07-22 pain in extremity The aches have moved into hands; Chills; Headache; Bad body aches; This is a spontaneous report from... Read more
The aches have moved into hands; Chills; Headache; Bad body aches; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the right arm on 31Mar2021 at 08:45 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history included crohns, IBD, fibromyalgia, sleep apnea, rheumatoid arthritis and juvenile idiopathic arthritis (jia). Concomitant medications included vedolizumab (ENTYVIO), duloxetine (MANUFACTURER UNKNOWN), pregabalin (MANUFACTURER UNKNOWN), trazodone (MANUFACTURER UNKNOWN) and nifedipine (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient previously took humira and experienced drug allergy. 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 31Mar2021 at 14:00, the patient experienced chills along with bad body aches. The chills went away but still having body aches and a headache every hour. On an unknown date in Apr2021, the aches have moved into hands. No therapeutic measures were taken as a result of the 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 event chills was recovered. The clinical outcome of the event bad body aches, headache and the aches have moved into hands were recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.
28 2021-07-22 tingling Sore neck; dizziness; pins and needles feeling while standing; Pressure feeling behind eyes; This is... Read more
Sore neck; dizziness; pins and needles feeling while standing; Pressure feeling behind eyes; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 02Apr2021 at 14:15 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy and COVID-19. Concomitant medications included valproate semisodium (DEPAKOTE ER) from an unknown date, for an unknown indication. The patient previously took Lamictal and experienced allergy. 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 11Mar2021 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 03:00 the patient experienced sore neck, dizziness, pins and needles feeling while standing and pressure feeling behind eyes. The adverse 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 of sore neck, dizziness, pins and needles feeling while standing and pressure feeling behind eyes was recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
28 2021-07-22 seizure PT HAD A SEIZURE SHORTLY AFTER VACCINATIONI LASTING ABOUT 1 MINUTE - WAS ALERT AND ORIENTED AFTERWAR... Read more
PT HAD A SEIZURE SHORTLY AFTER VACCINATIONI LASTING ABOUT 1 MINUTE - WAS ALERT AND ORIENTED AFTERWARD - PT CALLED HIS MOM TO PICK HIM UP AND SHE SAID SHE'D STAY WITH HIM TODAY. PT DOES NOT CURRENTLY HAVE A PRIMARY CARE MD BUT WILL LOOK FOR ONE NOW.
28 2021-07-26 seizure After receiving his 1 dose of the shot, patient did not wait as requested for 15 minutes. He went to... Read more
After receiving his 1 dose of the shot, patient did not wait as requested for 15 minutes. He went to the gas station next to the pharmacy , and while he was about to pump for gas he had a seizure attack. Patient came to the pharmacy to inform me of the incident. Patient sustained minor cuts and bruises on his chin, leg and hands. I was able to dress his cut by applying band aid after wiping with alcohol wipes. I did follow up with patient today and he's doing well.
28 2021-07-27 cold sweat six minutes after receiving vaccine patient complained of feeling as if his throat was closing up. P... Read more
six minutes after receiving vaccine patient complained of feeling as if his throat was closing up. Pt appeared pale and clammy. Vital signs BP 150/100, Heart rate 142, PO2 99. 2 doses of EPI given, EMS called. Pt was transported to Hospital.
28 2021-07-27 grand mal seizure Grand mal seizure
28 2021-07-27 numbness, pain in extremity, weakness from a contactable nurse (patient mother). A 28-year-old male patient (reporter son) received first ... Read more
from a contactable nurse (patient mother). A 28-year-old male patient (reporter son) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: ER8731, Expiration Date: 31Jul2021), via an unspecified route of administration on 19Apr2021 (at the age of 28-years-old) as dose 1, 0.3ml single for COVID-19 immunisation. The patient medical history included blood cholesterol increased. The reporter stated that she called for her son. She have a concern he had his first shot on 19Apr and that was Monday, last Monday and then Sunday he felt some symptoms and Sunday and Monday but he did not tell her until today. On the second day, on Monday a lot of fatigue, no energy, a little bit of nausea and he just slept it off and yesterday when he told her the symptoms he experienced. Its just because of the vaccine of the, she know its like less more than, less than a week 6 days after he said he felt some numbness on his left leg both legs but most in the left leg. He had some tingling pins and needles like on his mouth like numb on the left side of his body. She don't know if its related to the shot, it was 6 days after but she was concerned. He said, than he did not tell her he just let it go but he was like scared and then Monday in the evening, in the afternoon same thing happened like he just went to bed because he was not feeling well and he did not tell her he just said all he was just tired in his head its hurting and laid down and today is when he told her symptoms that he felt like he said mom like mom I read it looks like a TIA(Further not clarified hence not captured in tab). So, Sunday he felt like pain on both legs but most on the left leg. He felt like paralysis on the left side like numb on the left side and then he had some headache too, blurred vision and confusion. He had a shot on Sunday, on Monday it had some proximity. The reporter states that, she don't know if its related we had a shot on the 19, He do not have numbness or anything now. 25th he felt like he was sitting down himself. He said his left leg is paralysed. He said a little bit little for a short time he had blurry vision. He could not focus. He did not tell any of us about any of the symptoms. She guess he just went to sleep, it lasted 15 minutes. He just told her yesterday that his cholesterol was high according to his primary physician. she have not really called to find out exactly what the numbers are but he told her his cholesterol was high but he is not being treated for anything. He is not on any medication except for the vitamins that he takes every morning. That was January. She think its the usual CBC and CMT. she did not get a chance to see his results. She thinks he just did virtual, he just talk to the doctor and they talked about vital signs, she was not sure. She just corelated it because he just have it for almost a week that is why she was like could it be related, that is her concern and he is going to get his second dose in May 10. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
29 2021-01-03 numbness, facial paralysis Bell?s palsy, right side of face is numb, with difficulty closing eyes, smiling, raising eyebrows, e... Read more
Bell?s palsy, right side of face is numb, with difficulty closing eyes, smiling, raising eyebrows, eating, drinking, swallowing.
29 2021-01-03 numbness, speech disorder, involuntary muscle movements, inability to speak, mild one side paralysis, tingling left sided weakness; it has weakened his heart; stutter; severe stroke like symptoms; Ventricular ta... Read more
left sided weakness; it has weakened his heart; stutter; severe stroke like symptoms; Ventricular tachycardia/help keep his heart rate at bay; Loss of balance; extreme numbness and tingling in left hand and foot; tingling in left hand and foot; oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily; Issues finding words and trouble speaking; Issues finding words and trouble speaking; Ejection fraction down to 25%; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 28Dec2020, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other healthcare professional (HCP). A 29-years-old male patient received bnt162b2 (lot number: EJ1685), intramuscular (deltoid left) on 21Dec2020 at 05:30 at 0.3 mL single (first dose) for Covid. Medical history was reported as "none". Concomitant medications were not reported. The patient previously received Flu vaccine in Oct2020 for immunization. The patient is an Occupational Therapist, and he called to report an adverse event that he experienced with the first dose of the COVID Vaccine. He received the vaccine last Monday, 21Dec2020 at 5:30AM before his shift at work, then 20 minutes later, he was having severe stroke like symptoms. He experienced severe left sided weakness, loss of balance, extreme numbness and tingling in his left hand and foot, he had issues finding his words and he couldn't speak, and he had an oral motor impairment where his mouth was weak and not coordinated. The staff at the hospital did a neurological exam on him, and he failed, so he had to go to the emergency room (ER). The patient added that he was already in the hospital when this happened, and the ER doctors suspected that he had a CVA, and they gave him TPA to prevent any permanent brain damage and it worked. The patient then added that due to the shock of this whole event, from everything that happened, it has weakened his heart. Reportedly, he is a healthy 29 year old man, with no preexisting conditions, and he works out, and he has no heart conditions, but he had to get a cardiology follow up a few days after he got the vaccine, because he started going in to Ventricular Tachycardia, which he had never had in his life. So, the doctors at the hospital went ahead and did an Echocardiogram and an EKG, and he was told that his Ejection Fraction is down to 25%. He stated his heart is so weak, that he cannot work right now, but the structure of his heart is fine and has not had any damage. The hospital staff thought that maybe the patient had a chronic heart issue that he just did not know about, and that the stress of this event maybe made it kick into overdrive, but he states that the cardiologist said that was not the case, because the structure of his heart is fine, and the only thing they can see is that the heart is pumping weak. One physician even suggested that due to the shock of the event, he might have Takotsubo Cardiomyopathy, which is a broken heart, but because the structure of his heart is okay, it should be reversible. He stated that he is hoping he will heal up good, because he is young and has no pre-existing conditions. He added that his heart is in such a state right now; he has to wear an external defibrillator. The patient stated that all these happened about 20 minutes after he received the vaccine, and he was admitted to the hospital from 21Dec2020 to 25Dec2020. His neurological symptoms have resolved except that he has a stutter that he did not have before and his mouth is fatigued easily, so he has to slow down when he is eating, but now he can eat regular for the most part. The patient confirmed that he was not specifically prescribed the product; it was administered to him at his place of work, but it was optional. He stated he considered how he is working with COVID patients every day, and given the circumstance, he thought that it would be a best practice for him to get the vaccine. He had not gone to his primary care doctor in a while because he had been fine and healthy, but he called them and found out that his primary care had retired, so he has to find a new one now. Regarding the issues finding words and trouble speaking, he stated that he has improved, but it is still ongoing, he is just stuck in a plateau zone. With the Ventricular Tachycardia, he stated that this is an ongoing issue, as he has to wear the life vest even though he has no need to activate it yet. He did have one minor bought of the VTach, but because he is a therapist, he knows how to take care of it with relaxation techniques, he knows how to manage it. He had one bought of VTach the evening prior, but he was able to get it under control. The doctors have him on medication to help keep his heart rate at bay. He has never had to use medication before and is on the following medications to help keep his heart rate at bay: Metoprolol 25mg one tablet once daily by mouth and Lisinopril 5mg one tablet once daily by mouth. The VTach has improved, it was good enough he was able to discharge home, but it is still a concern. His cardiologist said that, basically his hope, is that once his body recover from the whole shock of everything, then his ejection fraction will heal, and his heart will heal. He again stated that the doctor told him that the structure of his heart is perfectly fine; he has thick walls in his heart, no leaking valves, and the heart was not conducting any abnormal signals. The doctor just said that right now, his heart is super weak and that it is an acute problem. With the Takotsubo Cardiomyopathy, he states that two doctors mentioned this diagnosis, but he confirmed that he was not actually diagnosed with this issue, he was just diagnosed with Ventricular Tachycardia. The outcome of the ejection fraction down to 25% was unknown to the patient at this time as he has not had another EKG or echocardiogram, but the cardiologist told him that the cardiologist expects that this will not be resolved quickly anyway. The patient confirmed that he did not receive any other vaccines on the same day he received the COVID vaccine. The only other vaccine he had this year was the flu vaccine which he got back in Oct2020. He has gone on to his online portal and there are the bloodwork results and all the imaging results on there from his CTs and MRIs, but he did not see the EKG or Echocardiogram results yet. He does not have this pulled up at this time, but he does have access to this stuff and can provide it later, if requested. He is curious about the next steps from here to how his case is processed. He is also curious if this information would help Pfizer make modifications to the vaccine if it is found that a lot of people are having the same reaction as he did. He is also wondering, given his situation, that probably he is not going to get the second dose, for his safety, but he is wondering what percentage of effectiveness the first dose does having just covered. The events left sided weakness, loss of balance, extreme numbness and tingling in left hand and foot resolved on 25Dec2020; severe stroke like symptoms and oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily resolved in 2020. The events ventricular tachycardia/help keep his heart rate at bay and issues finding words and trouble speaking were resolving, stutter had not resolved while the outcome of the events it has weakened his heart, and ejection fraction down to 25% was unknown.; Sender's Comments: The reported information is unclear and does not allowa meaningful assessment of the case. It will be reassessed upon receipt of follow up 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
29 2021-01-04 tingling Nausea; Chills; Injection site pain; Tingling in his arm; This is a spontaneous report from a non-co... Read more
Nausea; Chills; Injection site pain; Tingling in his arm; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), via intramuscular, on 28Dec2020 at 13:15, at single dose for COVID-19 immunisation. Vaccine location was left arm. No relevant medical history and concomitant medications were provided. The patient was vaccinated at workplace clinic, age at vaccination was 29-year-old. No other vaccine was received in four weeks. On 29Dec2020, the patient reported normal side effects of nausea, chills, injection site pain. Patient also reported that he was experiencing tingling in his arm. No therapeutic measures were taken as result of the events. Pre-vaccination and post-vaccination COVID tests were not performed. The patient had not recovered from the events. No follow-up attempts are possible. No further information is expected.
29 2021-01-05 pain in extremity 12/17 vaccination 12/20 Wen to use restroom. Reddish hue in urine. Went to urgent care. UTI was neg... Read more
12/17 vaccination 12/20 Wen to use restroom. Reddish hue in urine. Went to urgent care. UTI was negative. Positive for blood in urine. Next day, urine back to normal. Arm soreness
29 2021-01-06 weakness, unresponsive to stimuli Pfizer-BioNTech COVID-19 Vaccine EUA Injection given at 1420. He was watched for 15 minutes follow... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Injection given at 1420. He was watched for 15 minutes following vaccine administration without incident. Returned endorsing dizziness and nausea at 1455. Was tachycardic with HR in 130s with elevated BP with systolic in 150s. Given hydration and vitals monitored for about 45-55 minutes. Vitals downtrended and began to normalize. Stood to leave and became diaphoretic and weak. Placed in wheelchair for transfer down the hall to the ER and became unresponsive on the way. Was given epinephrine 0.3 mg to L thigh. Given IV fluids and acetaminophen. Returned to usual state of health and was discharged home.
29 2021-01-07 pain in extremity Normal after the inj. 8 hours later, arm pain, fatigue. Next day at noon, felt anxious, heart rate 1... Read more
Normal after the inj. 8 hours later, arm pain, fatigue. Next day at noon, felt anxious, heart rate 140's, extreme back pain, tachycardia. Lasted 12 hours 140 at rest. Movement 160 rate. Had chest pain. High fever 102-103.
29 2021-01-10 feeling cold The night of vaccine administration, I developed headached which progressed into the next day. For r... Read more
The night of vaccine administration, I developed headached which progressed into the next day. For roughly 24 hours I had fever, chills, total body aches, and headache. Symptoms completely resolved by 5am 1/10/21
29 2021-01-10 feeling jittery 0700- Vaccine 0800 -2200- Clear urine, 1-2 times per hour, 300-500ml each time 2200-2300 sleep 230... Read more
0700- Vaccine 0800 -2200- Clear urine, 1-2 times per hour, 300-500ml each time 2200-2300 sleep 2300 - woke up, felt jittery, provided car for emergent surgical case 0100 - felt like headed, drank 50oz water, felt better after 20 minutes 0400 - 0700 - sleep. Woke up 3 -5 times and urinated 300-500 each time clear urine 0800- 0900 - drove home 0900-1000- Urinated 3 times while attempting to fall asleep, each time 500ml if clear urine. Massive 10/10 right sided headache 1000-1300 sleep 1300- present- woke up. Felt ok, able to eat and drink, felt ?normal? by the following morning
29 2021-01-10 pain in extremity, weakness Received around 7-8pm on 12/22. Woke up 12/23 feeling okay, just L arm soreness however as day went ... Read more
Received around 7-8pm on 12/22. Woke up 12/23 feeling okay, just L arm soreness however as day went on progressively worsening chills, myalgias, malaise, headache, and extreme weakness/fatigue. Lasted 24-48 hours, peaking around 24-36 hours. Necessitated sick call out from work. Of note I had Covid in March and had antibodies prior to vaccination.
29 2021-01-11 flushing pt reported feeling flush, dizzy immediately after vaccine administration. It quickly resolved, VS W... Read more
pt reported feeling flush, dizzy immediately after vaccine administration. It quickly resolved, VS WNL. Observed for 30 mins pt reported initial symptoms resolved and no new ones have developed.
29 2021-01-11 flushing Red flushing over the arms and face (upper). No treatment administered. Duration of event: (1 hr app... Read more
Red flushing over the arms and face (upper). No treatment administered. Duration of event: (1 hr approx.)
29 2021-01-11 pain in extremity Dose 1 (12/16/20 9:30 am): L arm pain, malaise, fatigue, myalgias lasting 48 hours Dose 2 (1/06/21 ... Read more
Dose 1 (12/16/20 9:30 am): L arm pain, malaise, fatigue, myalgias lasting 48 hours Dose 2 (1/06/21 9:30am): L arm pain, malaise, fatigue, myalgias, severe rigors starting at 2am and lasting 3 hours
29 2021-01-13 muscle spasms, feeling cold, numbness, weakness, tingling Severe chills the evening of vaccination. Uncontrollable chills lasting 10pm 1/5 to 2:30am 1/6. Gene... Read more
Severe chills the evening of vaccination. Uncontrollable chills lasting 10pm 1/5 to 2:30am 1/6. General fatigue and weakness 1/6. Severe muscle spasms 1/7. Ongoing headaches, head pressure, mental ?fog? noticed 1/8 and continuing through when report was filed. Fog makes simple tasks seem very difficult. Seems always present, but sometimes much worse than others. Some facial numbness/tingling when head pressure is severe.
29 2021-01-13 pain in extremity, weakness At around 1:30 in the morning, i became really weak, achey, had the chills, some nausea, a minor hea... Read more
At around 1:30 in the morning, i became really weak, achey, had the chills, some nausea, a minor headache, a slight sore throat, and minor eye pain like they were dry. Though i I felt terrible, the most concerning side effect was that my skin felt like it was extremely raw in patches all over my body where if my sheets lightly touched one of those ?patches?, it would be very painful. However, there was no rash or discoloration from what I could tell. I also had strange painful sensations at the ends of my toes but were different in quality relative to the hypersensitive/raw painful sensations on my skin. The adverse events kept me awake for hours but when I finally got to sleep and woke up the next morning. I only had chills, weakness, and acheyness which were much less in severity than those early morning hours. It is now 4:45 pm and the only adverse effect I am still feeling is the fatigue. Also, I forgot to mention it on the medication portion but I had taken 400 mg of ibuprofen about 15 minutes before receiving that second dose.
29 2021-01-13 pain in extremity Sore left arm for 24 hours. Ache body and headache for 12 hours.; Sore left arm for 24 hours. Ache b... Read more
Sore left arm for 24 hours. Ache body and headache for 12 hours.; Sore left arm for 24 hours. Ache body and headache for 12 hours.; Sore left arm for 24 hours. Ache body and headache for 12 hours.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration at the left arm on 29Dec2020 18:45 at a single dose for COVID-19 immunization. Medical history included anxiety, asthma, seasonal allergies, known_allergies: PCN and dairy allergy. Concomitant medication included celecoxib (CELEXA, 40 mg) and cetirizine hydrochloride (ZYRTEC, 10 mg). On 30Dec2020, the patient experienced sore left arm for 24 hours. Additionally, she had ache body and headache for 12 hours. 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 for the adverse events. 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. The patient had Nasal Swabs for COVID-19 on 05Jan2021 and 06Jan2021, both results were negative. The outcome of the events was recovered on an unspecified date in Dec2020.
29 2021-01-14 weakness I was having like sore throat but not very severe almost like a tight throat; I was having like sore... Read more
I was having like sore throat but not very severe almost like a tight throat; I was having like sore throat but not very severe almost like a tight throat; Difficulty swallowing; I began to have a stuffy nose; Sleep restless; Upon swallowing I had increased amount of mucus going down; Since getting the second dose, I have been breathing more shallow; I have had tiredness, body aches, just not feeling well; I have had tiredness, body aches, just not feeling well; I have had tiredness, body aches, just not feeling well; I noticed my heart rate, it seems to be irregular; I feel like mine is like speeding up and just an irregular; Weakness, I have been super weak, I have not been able to do much physically/I have just been sleeping, just resting, my body is getting weak from that; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL3246), via an unspecified route of administration, on 05Jan2021 at 9:40 am at single dose for COVID-19 immunisation. Age at vaccination was 29-years-old. Medical history was none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Dec2020. Concomitant medications included multivitamins. He is a very health conscious individual. He is very healthy. On same day of getting the vaccine, 05Jan2021, on that evening the patient began to have a stuffy nose and then he had a very restless sleep. He woke up the very next day. On 06Jan2021, with difficulty swallowing. He was having like sore throat but not very severe almost like a tight throat. He noticed that he had, upon swallowing he had increased amount of mucus going down and then he noticed yesterday and today as well, it was like not difficulty breathing but very shallow breathing. He is typically a deep abdominal breather. Since getting the second dose, he has been breathing more shallow. He has noticed increased amount of tiredness. He has body aches, he is not sure about body aches because he has just been sleeping, just resting, his body is getting weak from that. He is not sure but he has had tiredness, body aches, just not feeling well. He is still able to eat and he is still able to drink. he noticed his heart rate, it seems to be irregular, not alarming but it was like, he is not sure if you are a coffee drinker but sometimes when you take caffeine your heart rate speeds up. He feels like his is like speeding up and just an irregular. Also, weakness, he has been super weak, he has not been able to do much physically. Outcome was unknown.
29 2021-01-14 hot flush Chills, Malaise, Hot Flashes - All symptoms waxing and waning in severity, present from 0230 - 2230 ... Read more
Chills, Malaise, Hot Flashes - All symptoms waxing and waning in severity, present from 0230 - 2230 on 01/14.
29 2021-01-15 muscle spasms, night sweats Fever (max 101.3), body aches, body chills, muscle cramps, night sweats, hives on face
29 2021-01-18 feeling jittery Abnormal diuresis from 8am to 10pm; Urinating 1-2 time per hour; woke up for midnight trauma/woke up... Read more
Abnormal diuresis from 8am to 10pm; Urinating 1-2 time per hour; woke up for midnight trauma/woke up 4 times in between; woke up for midnight trauma; Felt very jittery, although HR was 75.; extremely nauseous; lightheaded; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL0140), intramuscular at left arm on 08Jan2021 07:15 at single dose for COVID-19 immunization at a hospital. The patient's medical history included 1 kidney stone in 2019. No known 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 did not receive any other medications within 2 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EJ1685), intramuscular at left arm on 18Dec2020 07:15 for COVID-19 immunization at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. It was reported that the patient was vaccinated at 07:15. The events started on 08Jan2021 08:00. Detailed clinical course was reported das follows. Abnormal diuresis from 08:00 to 10:00. Urinating 1-2 time per hour, 300-500 ml per time. He went to sleep from 22:00 to 23:30, woke up for midnight trauma. He felt very jittery, although heart rate (HR) was 75. In the middle of surgical case, he became extremely nauseous and lightheaded. He left the operating room (OR) for 20 minutes and drank 50 oz of water and felt slightly better. He finished case at "an". He slept from 04:00 to 07:00. He woke up 4 times in between and urinated 300 500ml each time. He drove home from 07:00-08:00, felt nauseous. Laid in bed from 08:00 to 09:00 and urinated 3 times 300-500 ml each time. Slept from 09:00 to noon, felt better, urinating every 4-6 hours, appears back to normal routine. Treatment for the events included fluids. The outcome of the events was unknown. The reporter consider the events as non-serious.
29 2021-01-18 night sweats Fever, night sweat, fatigue, and diarrhea. Feel a little tired, but not extremely tired.
29 2021-01-18 night sweats Fever, chills, night sweats, muscle aches, joint aches all started approximately 14 hours after the ... Read more
Fever, chills, night sweats, muscle aches, joint aches all started approximately 14 hours after the vaccine (2100, 1/17,2021) and continued for approximately 6 hours (0300). Joint and muscle aches and pains however continued for approximately 24 hours (until 2100, 1/18/2021). Treatment was acetaminophen 1000mg q6-8h with little to no relief of symptoms.
29 2021-01-18 pain in extremity At midnight 1/17/2021I developed severe muscle aches, shivering, chills, and a temperature of 100 F.... Read more
At midnight 1/17/2021I developed severe muscle aches, shivering, chills, and a temperature of 100 F. The pain in my left arm was so severe I could barely move it. This all persisted to the morning of 1/18/2021 after which it resolved. I was unable to sleep at all the nights of 1/16/2021 or 1/18/2021.
29 2021-01-18 pain in extremity Beginning 1/17/2021 at midnight I developed shivering, chills, a temperature of 100 F, and severe mu... Read more
Beginning 1/17/2021 at midnight I developed shivering, chills, a temperature of 100 F, and severe muscle aches. My left arm was so painful I could barely move it. This persisted until the morning of 1/18/2021 and resolved. I also could not sleep at all the nights of 1/16/2021 or 1/18/2021.
29 2021-01-18 tingling Patient received Pfizer COVID vaccine at approximately 0850. Patient instructed to wait 15 minutes a... Read more
Patient received Pfizer COVID vaccine at approximately 0850. Patient instructed to wait 15 minutes after receiving vaccine. Observer reported to administering RN that patient was having symptoms of a reaction. RN immediately spoke with patient regarding statements. Patient stated he had tingling in his neck and then tightness along his mediastinum immediately following tingling. Vitals taken by RN at 0905. BP 164/84, P 108 and O2 98%. Tightness began to subside after approximately 5 minutes. Patient asked to stay an additional 30 minutes for observation. Vitals taken again at 0920. BP 144/82, P85 and O2 sat 99%. Patient stated he was no longer experiencing tightness of tingling at that time. Patient discharged from clinic and advised to contact his PCP before receiving second dose of Pfizer COVID vaccine.
29 2021-01-22 muscle spasms Uncontrollable shivers for about 20 min, with muscle spasms, and the tempature of 92°F lasting for... Read more
Uncontrollable shivers for about 20 min, with muscle spasms, and the tempature of 92°F lasting for about 30-45min.
29 2021-01-24 numbness Numbness to both legs; This is a spontaneous report from a contactable Other Health Professional (pa... Read more
Numbness to both legs; This is a spontaneous report from a contactable Other Health Professional (patient). This 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EL1283), intramuscular, on 13Jan2021 at single dose for COVID-19 immunisation. Vaccine location was right arm. Age at vaccination was 29-years-old. No other vaccine was received in four weeks. Medical history and concomitant medications were none. On 13Jan2021 at 09:00 PM, the patient experienced numbness to both legs, went to sleep and when he woke up both legs were completely numb. This had never happened to him before, so he assumes it's attributable to the vaccine. The event was reported as non-serious. No treatment was received for the event. Outcome was not recovered.
29 2021-01-26 migraine * 01/14/21 - Received first Pfizer COVID Vaccine. Felt really strange for first 10 mins after vaccin... Read more
* 01/14/21 - Received first Pfizer COVID Vaccine. Felt really strange for first 10 mins after vaccine. * 01/17/21 - Noticed my heart rate was at 120 bpm and I was extremely tired. * 01/24/21 - I noticed that I?ve started getting headaches more frequently. I rarely got headaches before (maybe 3-4 per year) * 1/25/21 - Had one of the worst migraines I?ve ever had. Blurred vision. * 1/26/21 - Went to the E.R. to get my heart checked because my heart rate was high and I was extremely tired. Also had a minor headache. * 1/27/21 - I still do not feel right. My heart flutters. Come and go headache. Very sleepy, though I had good sleep the night before.
29 2021-01-27 pain in extremity 8:00am-5:00pm. Headache, nausea, sore arm, lack of appetite.
29 2021-01-27 pain in extremity Headache; fatigue; irritable bowels; diarrhea; nausea; stomach cramps/stomach pain; arm soreness; ki... Read more
Headache; fatigue; irritable bowels; diarrhea; nausea; stomach cramps/stomach pain; arm soreness; kidney pain; the first dose of BNT162B2 was administered in the left leg; This is a spontaneous report from a non-contactable pharmacist, the patient. A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left leg on 23Dec2020 at 13:00 (at the age of 29-years old) as a single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 15:00, the patient experienced headache, fatigue, irritable bowels, diarrhea, nausea, stomach cramps/stomach pain, arm soreness, and kidney pain. The patient took lopearmde (MANUFACTURER UNKNOWN), sucralafate (MANUFACTURER UNKNOWN), and calcium carbonate (TUMS) as treatment. The clinical outcomes of the headache, fatigue, irritable bowels, diarrhea, nausea, stomach cramps/stomach pain, arm soreness, and kidney pain were not recovered. It was reported that the patient received the second dose of the BNT162B2 on 11Jan2021 (at the age of 29-years old; Lot Number: EL3302) in the right arm. No follow-up attempts are possible. No further information is expected.
29 2021-01-27 tremor Sweating; 38 degrees fever; Feverish chill; Shaking; This is a spontaneous report from a contactable... Read more
Sweating; 38 degrees fever; Feverish chill; Shaking; This is a spontaneous report from a contactable pharmacist (patient). A 29-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 11Jan2021 16:45 at a single dose for COVID-19 immunization. The patient has no medical history and concomitant medications. Previously, the patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on the right arm on 23Dec2020 14:45 for COVID-19 immunization. It was reported that approximately starting 10 hours after the patient received the vaccine (reported as 12Jan2021 03:00) he woke up in the middle of the night feeling feverish chill, but had no fever at the moment. Took Tylenol 1000 mg and slept, but still shaking. Starting around 11:00, he had 38 degrees fever, chill, and sweating for next 18 hours, where Tylenol 1000 mg q (every) 6h briefly dropped temperature to 37 degrees but spiked again when drug is excreted out. Then he maintained with 37 degrees for 12 more hours, then came back to normal. The patient reported that it looks like he had hyperimmune reactions. The events recovered on an unspecified date in Jan2021.
29 2021-01-28 weakness 1407: Patient c/o extreme dizziness and weakness stating "feels like all of the energy left my body"... Read more
1407: Patient c/o extreme dizziness and weakness stating "feels like all of the energy left my body", BP 150/80, P121, O2 99, denies hx of hypertension and post injection reactions, nurse offered juice and will increase monitor time. 1420: BP 160/84, P 118, dizziness persisted and c/o heaviness in tongue lasting about 4 seconds. 1430: BP 164/82, P 122, O2 98, nurse encouraged patient to go to ER for further evaluation, patient refused ambulance and stated "I have to call my supervisor". 1447: Supervisor arrived, patient still c/o dizziness and "feeling weird" 1503: Supervisor and nurse escorted patient to security vehicle for safety, patient will go to ER. Cormier, Markus, RN 1/29/2021 08:37:21 AM > Contacted patie
29 2021-01-28 pain in extremity, feeling of insects crawling on skin, numbness He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his l... Read more
He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his legs are actually numb. He also woke up sweating; He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his legs are actually numb. He also woke up sweating; He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his legs are actually numb. He also woke up sweating; he fell flat on the floor; felt really tired; arm feels like it was punched by a gorilla/his arm was sore/muscle sore; arm feels like it was punched by a gorilla/his arm was sore/muscle sore; He couldn't hardly move it sore; tingling, kind of like ants crawling up his leg; This is a spontaneous from a contactable consumer (patient). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via intramuscular route of administration on 13Jan2021 at 19:05 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Hepatitis B vaccine that is supposed to last for 10 years (which was administered for about three years ago) and flu vaccine. On 13Jan2021, patient received the vaccine and felt really tired, his arm feels like it was punched by a gorilla, it was sore. He couldn't hardly move it sore, like a muscle sore, so he went to bed. His arm was really, really sore, he's just kind of avoided using his arm. He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his legs are actually numb. He also woke up sweating. He didn't know his legs were numb until he literally got out of bed, and he fell flat on the floor because he could not feel them. He went to bed again and woke up at 7:20. On an unspecified date in Jan2021, he feels the tingling, kind of like ants crawling up his leg. It's not as bad as it was, it's like a feeling one gets when sitting on top of your legs. He wanted to know could these be side effects of the vaccine. The patient took Advil for arm feels like it was punched by a gorilla/his arm was sore/muscle sore. The patient underwent lab test which included COVID-19 PCR test with negative result on 10Jan2021. The outcome of the events arm feels like it was punched by a gorilla/his arm was sore/muscle sore, he couldn't hardly move it sore, numbness in leg was not recovered; sweating was recovered on an unspecified date, while unknown for the other events.
29 2021-01-31 discomfort, pain in extremity, feeling hot, feeling cold General body aches, compressed feeling. chills, second day big headache , cold and hot feeling , pa... Read more
General body aches, compressed feeling. chills, second day big headache , cold and hot feeling , pain in lower neck and spine, today minor headache and tired. sore arm all days.
29 2021-02-01 discomfort, pain in extremity 12hr after second dose: increased pain at injection site, but no swelling or redness; headache; Disc... Read more
12hr after second dose: increased pain at injection site, but no swelling or redness; headache; Discomfort is a 6/10; gradual onset of soreness raidiating from lymphnodes in neck; gradual onset of soreness in chest/ soreness in bronchi; gradual onset of soreness in back; gradual onset of soreness in hips; gradual onset of soreness in legs; gradual onset of soreness in glutes; soreness in upper lungs; soreness in upper respiratory system; This is a spontaneous report from a non-contactable consumer. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration on the left arm from 18Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included major depression, anxiety; increased airway sensitivity due to being former smoker from an unknown date and unknown if ongoing. Concomitant medication included vilazodone hydrochloride (VIIBRYD), loratadine (LORATADINE), theanine (THEANINE). The patient previously received the first dose on 28Dec2020 (Lot number=EK3730). There were no noticable effects after the first dose but 12hrs after second dose (19Jan2021), the patient experienced increased pain at injection site, but no swelling or redness. There was gradual onset of soreness raidiating from lymphnodes in neck, chest, back, hips/glutes, and legs; headache; soreness in upper lungs/bronchii (they are hypersensitive and usually sometimes get sore in reaction to irritants in the air), as well as upper respiratory system, but no difficulty breathing. Discomfort was at 6/10 on 19Jan2021. The outcome of the events was not recovered.
29 2021-02-05 muscle spasms Constipation, lethargic 24-72 hours onset after vaccine administered. Vomiting, diarrhea, nausea, c... Read more
Constipation, lethargic 24-72 hours onset after vaccine administered. Vomiting, diarrhea, nausea, cramping, bodyaches onset 72 hours to present time.
29 2021-02-06 feeling of insects crawling on skin, speech disorder Causing symptoms of SSRI withdrawal. Skin crawling, brain feels like electricity is running through ... Read more
Causing symptoms of SSRI withdrawal. Skin crawling, brain feels like electricity is running through it, racing mind, stumbling over my words and I'm taking my medication as directed.
29 2021-02-13 numbness, feeling cold, pain in extremity Approx. 8 hours following injection, on Friday, 2/5 at 3:45 p.m., began experiencing the following... Read more
Approx. 8 hours following injection, on Friday, 2/5 at 3:45 p.m., began experiencing the following symptoms: low grade fever (99.1 F); Left arm numbness and pain from deltoid to fingers; severe joint pain in L thumb, Index, and middle fingers; headache; chills; systemic muscular weakness; dizziness/nausea; extreme fatigue. Symptoms began to abate on Sunday 2/7 at approx. 8 p.m., and had completely abated by Monday 2/8 at 6 a.m.
29 2021-02-14 tingling, pain in extremity Within 5 minutes following administration: - Paresthesia and pain in left upper extremity extending ... Read more
Within 5 minutes following administration: - Paresthesia and pain in left upper extremity extending from shoulder to hand Within 48 hours following administration: - Progressive pain in left upper extremity - Greatly reduced range of motion in left upper extremity - Inability to bear any weight in left upper extremity - Large ecchymotic lesion at head of left humerus After 48 hours to current presentation: - Pain in the left proximal arm, left shoulder, left upper back, and left neck extending to the occiput - Painful spasticity in the left proximal arm, left shoulder, left upper back, and left neck extending to the occiput - Pain-restricted impaired range of motion of the neck including flexion, extension, lateral rotation, medial rotation, and lateral bending - Pain restricted impaired range of motion of the left upper arm including flexion, extension, lateral rotation, medial rotation, and abduction - Painful left-sided dysphagia at the level of the cricoid cartilage - Use of left arm impaired versus baseline with no signs of improvement
29 2021-02-20 pain in extremity Sore arm
29 2021-02-24 feeling hot 29M hx HTN who obtained his first COVID vaccine. Few minutes after receiving the vaccine, he reporte... Read more
29M hx HTN who obtained his first COVID vaccine. Few minutes after receiving the vaccine, he reported to provider that he felt warm and dizzy. He was immediately brought to the enclosed first responder area where he mentioned additional sx of nausea. Vasovagal response, Dizziness, Hypotension, nausea
29 2021-03-02 cold sweat Chills, anxiety, cold, clammy, chest tightness, SOB
29 2021-03-02 feeling hot blacked out and loss consciousness twice; hit head and make a gauche on eyebrow needing stiches; hit... Read more
blacked out and loss consciousness twice; hit head and make a gauche on eyebrow needing stiches; hit head and make a gauche on eyebrow needing stiches; whole body was feverishly hot; This is a spontaneous report from a non-contactable consumer (patient). A 29-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), via an unspecified route of administration on 13Feb2021 10:30 (at 29-years-old) at single dose (Left arm) for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), on 23Jan2021 03:30 PM (at 29-years-old) on Left arm for COVID-19 immunization. Facility type vaccine was reported as Other. There were no other vaccine administered in four weeks. There were no other medications in two weeks. Approximately 12-24 hours after second dose, whole body was feverishly hot, blacked out and loss consciousness twice within 30mins of each other waking up on the floor from standing position, causing to hit head and make a gauche on eyebrow needing stiches. Events started on 14Feb2021 04:00. Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of hit head and make a gauche on eyebrow needing stiches. The outcome of the events was recovering. No follow-up attempts are possible. No further information expected.
29 2021-03-04 cold sweat, migraine Migraine Muscle aches Fatigue Severe Nausea Fever Cold Sweat
29 2021-03-12 pain in extremity Received vaccination on 03/12/2021 at 4:04PM. Symptom onset 03/13/2021 around 10:00AM: soreness at i... Read more
Received vaccination on 03/12/2021 at 4:04PM. Symptom onset 03/13/2021 around 10:00AM: soreness at injection site (left deltoid muscle), soreness in leg muscles, fatigue, nausea, chills, dizziness, runny nose, cough, and worry. Axillary temperature: 98.6F.
29 2021-03-15 tingling, pain in extremity Both Arm soreness, both hands soreness/ tingling, Dizziness, Nausea, Tingling of lips, large patches... Read more
Both Arm soreness, both hands soreness/ tingling, Dizziness, Nausea, Tingling of lips, large patches of painful itchy welts covering body including arms, torso, groin area. Took benedryl for two days, welts subsided, soreness remained. Sought out medical attention from physician on 3/16 and was given a steroid injection and prescribed a steroid pack and OTC pepsid as well as continuing the use of benedryl.
29 2021-03-19 weakness Patient reported fast heartbeat, sweating. Patient was pale, HR 112, O2Sat 96%, BP 108/60, reported... Read more
Patient reported fast heartbeat, sweating. Patient was pale, HR 112, O2Sat 96%, BP 108/60, reported feeling dizzy, vision changes, had brief moment of syncope, then aroused, Oxygen applied at 2l via NC, patient continued with sweating, HR now 78, EMS called, patient continued with sweating and feeling weak gradual improvement, EMS arrived, patient evaluated and did not want to go to ER for eval. Vitals rechecked and patient ambulated to private vehicle with no further difficulty.
29 2021-03-20 tremor, cold sweat patient received their first dose of the Pfizer covid immunization. during observation, the patient ... Read more
patient received their first dose of the Pfizer covid immunization. during observation, the patient got extremely red and lost consciousness. upon waking up, the patient began having cold sweats and lost color in this face, the patient then lost consciousness again and began shaking. 911 was called. the patient was moved to the ground with the help of a fellow team member. blood pressure was taken and was 106/62. heart rate was around 60. patient began getting color back but remained on the floor until the paramedics came.
29 2021-03-22 tingling Light headedness, tingling feeling all over body and excessive vomiting (in this progressive order).... Read more
Light headedness, tingling feeling all over body and excessive vomiting (in this progressive order). All of this occurred within 2 hours of receiving the vaccine.
29 2021-03-23 bell's palsy, facial paralysis Bell's Palsy/ facial droop
29 2021-03-25 discomfort, pain in extremity I felt soreness and pressure build up in my arm starting a few hours after the receiving the dose. T... Read more
I felt soreness and pressure build up in my arm starting a few hours after the receiving the dose. The soreness and pressure got progressively worse over the course of two days. It wasn't unbearable, just uncomfortable. The second day after the vaccine I had stretched my arm pretty good for minute, when I released the stretch I felt a rush of something for from my arm into my torso. I got really dizzy and passed out, my wife was in the room at the time and said I never closed my eyes; but I had completely blacked out. My wife had woken me up and I wasn't sure what had happened, it took me about 30 seconds to realize I had passed out after stretching that arm. My arm had felt better after waking up from passing out, and soreness had passed a couple days later. I didn't get checked out, after I woke up I started feeling fine. I'm honestly not sure if it's directly related to the vaccine or not, I just thought I should let someone know just in case.
29 2021-03-25 feeling hot, tingling Sweaty Warm Anxious Parasthesia
29 2021-03-28 burning sensation, weakness Intermittent Chest Pain, Palpitations, burning sensation in the area of the heart, weakness, hyperve... Read more
Intermittent Chest Pain, Palpitations, burning sensation in the area of the heart, weakness, hyperventilation due to pain, inability to sleep, and chronic cough while standing or sitting but not while laying prone. Seen at Atrium Health Urgent Care Clinic Shelby NC on 14 Mar 2021. Then at the Emergency Room CaroMont Regional Medical Center Gastonia NC on 17 Mar 2021. Seen by PA-C on 19 Mar 2021 at Novant Health Family Physicians of Gastonia. Then seen again at the Emergency Room CaroMont Regional Medical Center Gastonia NC on 20 Mar 2021. Symptoms have begun to subside as of the date 28 Mar 2021 with the exception of the chronic cough.
29 2021-03-28 tingling difficulty, swallowing and breathing. Rapid heart beat, tingling in the throat and cheeks
29 2021-03-30 flushing The patient had a syncopal event, followed by flushing and vomitting. He received the vaccine at 9:3... Read more
The patient had a syncopal event, followed by flushing and vomitting. He received the vaccine at 9:30am and the event occurred at 9:32am and lasted 30 seconds. He then became extremely flushed and dizzy. He was given a cool compress and bottle of water. I observed him for 7 minutes and then he began to vomit. After vomiting, I observed him for 15 more minutes, personally, and then had him wait in our waiting area for 15 additional minutes.
29 2021-03-31 hot flush I started feeling a headache around 9:00 P.M. Eventually around 11-12:00; I started experiencing bod... Read more
I started feeling a headache around 9:00 P.M. Eventually around 11-12:00; I started experiencing body aches and chills. Eventually in between the hours of 12:00 A.M. to 4:00 A.M. I started a fever. I dealt with varying degrees of the previous stated symptoms throughout the day with varying effectiveness with OTC Tylenol. On Friday, most of the symptoms had dissipated, however I did experience random bouts of hot flashes.
29 2021-04-01 pain in extremity Soreness of injection site, sympathy pains in other arm
29 2021-04-01 unresponsive to stimuli Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Pa... Read more
Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient had a vasovagal reaction. He states he has had this occur previously. Orthostatic vitals: lying 176/81 HR 81, sitting 129/86 HR 82 standing BP 119/82 HR 83, Pulse OX 99%
29 2021-04-02 tingling, numbness 28 y/O male immediately post-vaccined reported feeling faint and lightheaded. The patient was assis... Read more
28 y/O male immediately post-vaccined reported feeling faint and lightheaded. The patient was assisted to a wheelchair and taken for observation. He reports no known h/o vasovagal symptoms. He did however admitted he had not eaten. He was placed in Trendelenburg position for recovery and later sat up after being offered crackers and a drink. Vitals 151/76 HR, 65 O2 sat 98%. The patient was unable to complete the snack and started to experience chills, fatigue, chest pressure with palpitation and numbness and tingling down his left arm. EMS was called. The patient was observed for additional time, the chills resolved but but the chest pressure and lightheadedness persisted,
29 2021-04-03 numbness Dry mouth 10-15 mins after shot Swollen throat/discomfort swallowing about 45 mins after shot Numbne... Read more
Dry mouth 10-15 mins after shot Swollen throat/discomfort swallowing about 45 mins after shot Numbness feeling in face about 1 hour after shot
29 2021-04-04 feeling cold Injection site tenderness, pain, and bleeding; headache, sweating, chills, full-body muscle and join... Read more
Injection site tenderness, pain, and bleeding; headache, sweating, chills, full-body muscle and joint aches, lethargy, malaise, runny/stuffy nose. Started a couple hours after the dose and continued for two days after.
29 2021-04-06 tingling The patient developed lightheadedness, tightness in his chest, and tingling of his hands about two m... Read more
The patient developed lightheadedness, tightness in his chest, and tingling of his hands about two minutes after receiving the vaccination. He said that he felt anxious that something was happening. He was hyperventilating. During the event, his heart rate was normal (in the 70s-80s), his blood pressure was normal (SBP in the 130s to 140s), and his oxygen saturation was 100%. He was able to communicate without difficulty, he did not have any weakness, chest pain, diplopia, dysarthria, dysphagia, trouble with walking/balance, bowel/bladder dysfunction, or pain elsewhere in his body. He had a bottle of water. His symptoms lasted about 30 minutes, and then resolved completely.
29 2021-04-08 feeling cold, cold sweat Client had a vasovagal response, became diaphoretic, cool and clammy. Lips were pale. Client never... Read more
Client had a vasovagal response, became diaphoretic, cool and clammy. Lips were pale. Client never lost consciousness. Client recovered within 15 minutes. Administered ammonia inhalant. Pt. was bradycardic which resolved within 10 minutes. Client movd to holding/observation.
29 2021-04-08 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe
29 2021-04-09 feeling cold patient stated was sitting in the chair after receiving the vaccine 10 minutes later he started expe... Read more
patient stated was sitting in the chair after receiving the vaccine 10 minutes later he started experiencing dizziness and light headiness then he started feeling cold and feverish at one time like he was about to pass outpatient was evaluated and assessed the vitals are as followed 2:44p b/p 112/65 p 98 r 18 sat 98% 3:00p b/p 117/73 p 93 r 18 sat 93% 3:10p b/p 120/74 p 83 r 18 sat 98% patient stated he was feeling better patient was wheeled to the front entrance patient was encouraged to go to the nearest ER was to reoccur. Patient was released home.
29 2021-04-09 pain in extremity Soreness in arm
29 2021-04-09 throat numbness, numbness throat numb; Numb lips; face started to feel numb; Feel asthmatic; My head felt cloudy; This is a sp... Read more
throat numb; Numb lips; face started to feel numb; Feel asthmatic; My head felt cloudy; This is a spontaneous report received from a contactable consumer (patient). A 29 years old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EP7533 and Expiration Date unknown) via an unspecified route of administration on 03Apr2021 01:30 PM (vaccine location: Left arm, vaccination age:29 years old) at single dose for COVID-19 immunisation. The patient's medical history included peanut allergy and asthma. The patient was not diagnosed with COVID-19 prior to vaccination. The concomitant medications included Loratadine, Montelukast, salbutamol (ALBUTEROL HFA), ciclesonide (ALVESCO). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Around 30-40 minutes afterwards after vaccine (reported as 03Apr2021 02:00 PM), patient experienced lips, throat, and face started to feel numb. Additionally, patient started to feel asthmatic and head felt cloudy. Seriousness criteria was provided as life-threatening for events. Treatment received for event included Benadryl. The outcome of event was recovered in Apr2021. No follow-up attempts are possible. No further information is expected.
29 2021-04-09 tenderness Left axillary lymph node inflamed, red, and tender. 4.5 cm x 2.0 cm. Difficulty moving left arm due... Read more
Left axillary lymph node inflamed, red, and tender. 4.5 cm x 2.0 cm. Difficulty moving left arm due to pain. Patient has taken Ibuprofen and Tylenol PRN. He also did warm heating pad. No improvement.
29 2021-04-09 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe
29 2021-04-10 tingling Pt called c/o tingling on bilateral hand , foot and face after 20 minutes of receiving Pfizer vaccin... Read more
Pt called c/o tingling on bilateral hand , foot and face after 20 minutes of receiving Pfizer vaccine. Pt advised to come back to the clinic pt monitored for 45 minutes. Pt reports that she does not have tingling in her foot any more. Pt denies any SOB, any fast heart beat, swelling of face or throat, rash , dizziness or weakness. Spoke with the pt on 4/11/2021 10AM . Pt reports that she does not have any more tingling sensation.
29 2021-04-11 hot flush, feeling cold The day after I got my 2nd dose I woke up with a mild fever of 99.9 which came and went throughout t... Read more
The day after I got my 2nd dose I woke up with a mild fever of 99.9 which came and went throughout the day and continued on and off for 3 days. During those 3 days, I had severe body aches and fatigue. I slept 16-18 hour nights and struggled to stay awake. I had hot and cold flashes throughout the evenings from the night of the vaccine and the 2 nights following that (3 nights total). I had a loss of appetite during those 3 days and on day 4 finally started to feel normal.
29 2021-04-11 pain in extremity Arm pain all the way down
29 2021-04-11 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted in store after receiving... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted in store after receiving first dose of Pfizer Covid vaccine. Patient regained consciousness within a minute and reported no other injuries. Patient was guided by pharmacist on duty to lie down with feet propped up. Patient remained in room for approximately 30 minutes after which patient confirmed that he was feeling fine. Patient will call pharmacy if any new symptoms develop
29 2021-04-12 numbness After 10 minutes of receiving vaccine, patient reported that his left side of face felt a little num... Read more
After 10 minutes of receiving vaccine, patient reported that his left side of face felt a little numb. He also complained of feeling dizzy. Patient was brought to exam room. BP was elevated 160s/90s. Stroke ruled out, no drooping noted in face. Patient able to move upper extremities fully and symmetrically. Patient was observed for 15 minutes. BP rechecked. BP decreased to 131/80. Patient observed for 15 more minutes. Patient reports cessation of numbness and dizziness. Patient was able to walk out of clinic alert and without assistance. Patient encouraged to make appointment with PCP to check for undiagnosed HTN. Patient denied having a PCP. Encouraged to find PCP or sign up at clinic.
29 2021-04-12 pain in extremity, seizure Patient had a seizure on the day of the Pfizer vaccine as well as arm & leg pain due to fall
29 2021-04-14 flushing, tremor, weakness Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Sy... Read more
Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
29 2021-04-15 seizure This patient had received vaccination and was scheduling next appt in observation area. Medical aler... Read more
This patient had received vaccination and was scheduling next appt in observation area. Medical alert called overhead. RN responded to alert. Pt conscious, but per RN, in observation area, she stated he had a loss of consciousness and although she tried to break his fall, he did hit his head on the wall. Pt was sitting in chair, vitals attempted to be assessed, no reading, but patient alert. Before vitals were repeated,16:18 pt eyes drifted left and closing, another loss of consciousness, followed by convulsions and gasping sounds from the throat. Pt convulsed and left leg /foot turned inward torsion. Pt was removed from chair by 3 RN's to floor safely. approximately 15-30seconds of convulsion. pt regained consciousness AOX4. Pt remained laying, head propped on cushion. vitals taken 16:24 BP 108/69 86bpm, 100%O2Sat. MD assessed and pt stable. MD provided recommendation for pt to be evaluated at ED for further evaluation due to the convulsions. Pt accompanied by friend, friend agreed to drive pt to ED. Blood Glucose 90, which was taken at 1630. Wheelchair was provided for patient, RN rolled pt out to car and friend designated driver.
29 2021-04-15 seizure <10 minutes after vaccination, patient had syncope episode, fall broken by another person, slight bu... Read more
<10 minutes after vaccination, patient had syncope episode, fall broken by another person, slight bump to head. Patient became conscious, was seated on a chair, and then had second syncope episode followed with convulsions. Stabilized patient. Vitals monitored, assessed by MD and released with referral to PCP.
29 2021-04-16 flushing Flushing/sweating, dizziness BP 113/72, HR 70, RR 14 -- > 109/63, HR 63, RR 16. Water was given, th... Read more
Flushing/sweating, dizziness BP 113/72, HR 70, RR 14 -- > 109/63, HR 63, RR 16. Water was given, therapeutic talk, patient layed down until he felt better. Patient stable and released from vaccination site
29 2021-04-16 muscle spasms Fever, nausea, cramping, body aches, head/chest congestion.
29 2021-04-16 pain in extremity Arm sore/pain, tiredness, tight throat, Poor appetite, slightly chilling but no fever
29 2021-04-17 migraine, tension headache Severe vice like headache morning after vaccine - headache persists despite OTC meds - Wednesday cam... Read more
Severe vice like headache morning after vaccine - headache persists despite OTC meds - Wednesday came home from work at 10 AM nausea - went to ER Friday treated for migraine - given IV fluids and migraine cocktail (Toradol, Benadryl and Zofran) headache returned 2 hours after meds given - headache persists so had Covid test done Sunday afternoon and will make appointment with PCP on 4/19
29 2021-04-17 night sweats Nausea beginning about 6 days after vaccine; repeated vomiting and, for 10 hours, inability to retai... Read more
Nausea beginning about 6 days after vaccine; repeated vomiting and, for 10 hours, inability to retain even small amount of any fluid without vomiting; vomiting occurred one more time 30 hours after onset after eating small amount of chicken soup; night sweats, chills, and joint pain accompanied vomiting; night sweats and joint pain remain to date, approximately 4 days after onset of symptoms; no diarrhea. Vomiting was far worse than ever experienced in memory, except possibly when having a stomach bug as a child.
29 2021-04-17 pain in extremity 4/9/21- pain in left arm 4/10/21 to 4/13/21 - body aches and sore 4/13/21 to 4/15/21 - body aches w... Read more
4/9/21- pain in left arm 4/10/21 to 4/13/21 - body aches and sore 4/13/21 to 4/15/21 - body aches went away, started diarrhea. Eating was normal around 4/13/21 and then ate less because of the diarrhea and stomach aches/cramp increasing 4/15/21 (evening) - ate a bit of sushi, instant diarrhea and vomitting. Vomitted 4 times and 12 times of diarrhea from 18:00 to the next morning. 4/16/21 - vomitting stopped and not really nauseous but still diarrhea. Ate a half banana at night and drank water 4/17/21 - ate half a banana in the morning made me super nauseous but didn?t vomit. Ate a lipton soup for diner, drank water and apple just during the day. Night: slept good from 22:30 to 2:30 and then diarrhea every hour.
29 2021-04-17 seizure Patient received shot and told us about 2 minutes later that he did not feel good. His eyes rolled b... Read more
Patient received shot and told us about 2 minutes later that he did not feel good. His eyes rolled back into his head and he lost consciousness. He started convulsing and seizing for about 20 seconds.
29 2021-04-18 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: a... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: after receiving 2nd shot, patient feels dizziness and swating, feels like passing out. but he was alert. asked about diabetes issue and he denied. offered gatoraid and he said he would like to drink that and provided one bottle with store manager's authorization and after 20 minuts he was feeling better.
29 2021-04-19 feeling cold Very anxious prior to injection, became lightheaded directly after injection. Then became nauseated... Read more
Very anxious prior to injection, became lightheaded directly after injection. Then became nauseated and began vomiting. Diaphoretic and pale in color, assisted to monitoring room with cot for client to lay down. Became chilled ,warm blankets placed on client and continued to monitor. PSO2 99 % b/p120/78 pulse 80 Client improved ready to be released. Informed to see medical attention for any further problems.
29 2021-04-21 weakness Heart rate increase, body weak, shortness of breathe, stomach pain, rib cage hurts, heart hurts
29 2021-04-22 involuntary muscle movements Four hours after receiving my 2nd vaccine, I fainted while standing in my kitchen. Bystanders said I... Read more
Four hours after receiving my 2nd vaccine, I fainted while standing in my kitchen. Bystanders said I was out cold for about 1 minute, and was flailing my arms and legs, but did not appear to be a full on seizure.
29 2021-04-23 feeling cold Body aches, chills, sweating, possible fever
29 2021-04-23 unresponsive to stimuli, tremor, flushing Systemic: Chills-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Seve... Read more
Systemic: Chills-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Additional Details: none
29 2021-04-23 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient complained of feeling light he... Read more
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient complained of feeling light headed and then passed out. He was laid on the floor until he regained consciousness. We called EMS and kept an eye on the patient. EMS arrived and checked him out and he was responsive and was sent home.
29 2021-04-24 tremor Dehydration (Severe); Trembling / Shaky Feeling (Occasional - Moderate); Lethargy (Moderate); Body A... Read more
Dehydration (Severe); Trembling / Shaky Feeling (Occasional - Moderate); Lethargy (Moderate); Body Ache (Moderate); Trembling / Shaky Feeling (Occasional - Moderate); Light Fever; Nausea (Severe); severe headache; This is a spontaneous report from a contactable consumer. A 29-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 08Apr2021 at 12:00 PM (at the age of 29-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 17Mar2021 at 1:00 PM as single dose for COVID-19 immunization. There was no list of any other medications the patient received within 2 weeks of vaccination.The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination.There were no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 at 10:00 AM, the patient experienced moderate lethargy, moderate body ache, severe nausea, severe dehydration, occasional - moderate trembling / shaky feeling, light fever and severe headache. The events were considered serious due to medically significant. The patient was admitted to emergency room and Intravenous treatment was administered for the events. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
29 2021-04-25 flushing pt received covid shot. waited around the 15 minutes after and girlfriend reported that he fainted ... Read more
pt received covid shot. waited around the 15 minutes after and girlfriend reported that he fainted in the aisle. He had a gash on his scalp and said he fainted. We put in in a chair with legs raised. took bp and hr. all were normal. pt reported he was still feeling faint and flushed so we called the emt. amubulance and fire truck came. pt reported feeling better and refused medical care.
29 2021-04-26 involuntary muscle movements 1455 1ST DOSE PFIZER VACCINE ADMINISTERED 1457 PT WITH LOSS OF CONSCIOUSNESS, WITH ARMS AND LEGS JER... Read more
1455 1ST DOSE PFIZER VACCINE ADMINISTERED 1457 PT WITH LOSS OF CONSCIOUSNESS, WITH ARMS AND LEGS JERKING MOVEMENTS. AMMONIA INHALANT USED, PT AROUSED AFTER STERNAL RUB AND INHALANT. ORIENTED TO SITUATION PROVIDED. PT STATES "I'M SO EMBARRASSED, I FELT THAT COMING ON" 911 CONTACTED AND PT ASSISTED TO STRETCHER. 1458 BP 137/81 HR 72. PT DENIES ANY OTHER COMPLAINTS. DOES CONFIRM HE WAS ANXIOUS ABOUT INJECTION AND WAS SCARED HE WOULD FAINT. 1500 EMS HERE, BP128/80 HR 92. PT REFUSED TRANSPORT WITH EMS AFTER DISCUSSION WITH EMTS. 1530 PT STATES FEEL OK TO LEAVE WITH GIRLFRIEND DRIVING. BP 165/64 HR 65. DENIES ANY COMPLAINTS. INSTRUCTED TO CALL 911 OR SEEK MEDICAL ATTENTION IF NEEDED. VOICED UNDERSTANDING.
29 2021-04-27 feeling cold Cold chills, fever, headache, body ache, fatigue, nausea. This effect happened on both shots to the ... Read more
Cold chills, fever, headache, body ache, fatigue, nausea. This effect happened on both shots to the same intensity.
29 2021-04-27 night sweats Got shivers and a fever 102F. The fever was broke by 2 Acetaminophen. 100F Fever lasted for a day an... Read more
Got shivers and a fever 102F. The fever was broke by 2 Acetaminophen. 100F Fever lasted for a day and a half. I had night sweats from the first night on Wednesday which gradually receded ending on Saturday night.
29 2021-04-27 tremor, unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Additio... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Additional Details: PATIENT RECIEVED VACCINE AND WAS WAITING IN DESIGNATED AREA AND TRIED TO MOVE AND FAINTED - RPH WAS NOTIFIED AND PT BP WAS CHECKED WNL AND PT WAS GIVEN WATER AND SPOKEN TOO AND STARTED TO FEEL BETTER AFTER 5 MINS
29 2021-04-28 weakness Dizzy, faint, blurred vision, headache started 5 minutes after shot. I was wheelchaired to fresh air... Read more
Dizzy, faint, blurred vision, headache started 5 minutes after shot. I was wheelchaired to fresh air and moved to a cot for 30 minutes of monitoring. I slowly recovered over the 30 minutes. The following day I had a 99.6 fever, headache, chills and weakness. The vaccination site is sore.
29 2021-04-28 cold sweat Pain at injection site, headache, fever, nasal/sinus congestion and cold sweats.
29 2021-04-28 pain in extremity unprovoked right leg DVT; bilateral PEs; Factor V Leiden positive (hetereozygous); right leg swellin... Read more
unprovoked right leg DVT; bilateral PEs; Factor V Leiden positive (hetereozygous); right leg swelling and pain progressively worsening; right leg swelling; This is a spontaneous report from a contactable consumer (patient). A 29 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jan2021 10:00 (Lot Number: EL1283) as SINGLE DOSE for COVID-19 immunisation. The patient previously had first dose of BNT162B2 on 29Dec2020 at the age of 29 years old for COVID-19 immunisation. Medical history included pleural effusion w/ thoracentesis x2 (5 years ago), known allergies: penicillin and sulfa drugs from an unknown date and unknown if ongoing. Concomitant medication included armodafinil 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 workplace. 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 been tested for COVID-19 (nasal swab): negative on 28Jan2021. On 28Jan2021, the patient presented to the ED with right leg swelling and pain progressively worsening over the past week. Subsequently diagnosed with unprovoked right leg DVT and bilateral PEs, admitted overnight and given anticoagulation therapy. Labs ordered and reviewed with hematology consult 1 week later and found to be Factor V Leiden positive (hetereozygous). Treatment plan therapeutic dose of Eliquis twice a day for 1 year, prophylactic dose indefinitely after that. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The events were reported as life threatening illness as patient was in immediate risk of death from the events. The patient was hospitalized for 1 day. The events was recovering. The events was treated with anticoagulation therapy, pain medicine and stockings.
29 2021-04-28 seizure, weakness, flushing, unresponsive to stimuli, tremor Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: conv... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: convulsion-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: patient recieved first dose, went to go sit in observation area, few minutes later fell forward off his chair and starting having a seizure. called 911. patient was able to get up and sit in chair with feet elevated. paramedics came, patient refused hospital visit. Patient was oriented and went home after the paramedics.
29 2021-04-28 seizure Pt reported having one seizure the evening of his vaccination and two seizures back to back the morn... Read more
Pt reported having one seizure the evening of his vaccination and two seizures back to back the morning after his vaccination. Per neurology, pt will be admitted to an epilepsy monitoring unit to better characterize the seizures.
29 2021-04-29 cold sweat, unresponsive to stimuli Syncope Vital Signs: BP 110/80 HR 82 O2Sat 95% Skin Signs: Clammy, diaphoretic, Other - Pale Circ... Read more
Syncope Vital Signs: BP 110/80 HR 82 O2Sat 95% Skin Signs: Clammy, diaphoretic, Other - Pale Circulation: Cap refill <2sec Initial Treatment: Raised legs, patient had moved from original position 911 called - denied 7:25 PM: Vital Signs: BP 110/77 HR 76 Resp 16 O2Sat 97% Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: Laying down on cot, Juice box 7:41 PM BP 110/75 Notes: Provider called to patient side due to patient becoming unresponsive in chair. Patient assisted to floor and noted to be unresponsive. Pale, diaphoretic, and pupils dilated. Patient did not initially have a palpable pulse, however, initiate CPR patient became responsive. AOx3. EMS arrived and evaluated. Home with wife.
29 2021-04-29 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
29 2021-04-29 seizure Suffered a seizure in the minutes after injection. Urinated on self.
29 2021-04-30 weakness, feeling of body temperature change Started out feeling out of energy about 12 hours after the 2nd dose along with having aching arms an... Read more
Started out feeling out of energy about 12 hours after the 2nd dose along with having aching arms and legs. Around 14 hours after the dose I got a fever, chills, hot flashes. Took Tylenol and went to bed Went to bed and kept waking up feeling hot or cold. Woke up in the middle of the night and experienced a vivid hallucination. This morning as I write this I still have a small fever and headache, running nose. My arm became really sore at the site of injection.
29 2021-04-30 weakness Approximately 5 minutes after vaccine administration, pt. C/O tiredness, weakness/fatigued, slow l... Read more
Approximately 5 minutes after vaccine administration, pt. C/O tiredness, weakness/fatigued, slow loss of vision. He was guided to a flat surface in a supine position with legs elevated , Slow deep breaths were encounter, ice pack applied at the back of his neck. Vitals included 90/60, 68, @18, 98% RA. Pt. Was alert and oriented x4. At 11:44 am, second vitals were, 110/70, 57, 26, t=98.2, @ 98%RA. Vision was restored back tk normal with minimal dizziness. At 11:44, all symptoms had subsided as per pt. report. Pt. did mmot experience any falls or trauma while at the clinic. At
29 2021-04-30 burning sensation Widespread hives/rash in middle stomach and lower back, with accompanying burning sensation on conta... Read more
Widespread hives/rash in middle stomach and lower back, with accompanying burning sensation on contact. First noticed late Thursday but spread rapidly overnight, prompting doctor visit. Doctor prescribed Xyzal, famitodine and a topical cream. Hives have not responded to treatment and have continued spreading to neck.
29 2021-04-30 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild
29 2021-05-01 tremor At 1100, patient reported feeling shaky, dizzy, and faint to EMT. Patient had unlabored respirations... Read more
At 1100, patient reported feeling shaky, dizzy, and faint to EMT. Patient had unlabored respirations, alert and oriented x4, and able to follow commands. Patient assisted to anti-gravity chair. EMT assessed patient vitals: blood pressure 98/58 mmHg, heart rate 42 beats/minute, and SpO2 96%. Patient reported not eating breakfast. Patient given water and crackers. Patient advised to wait for further observation. Patient reassessed at 1130. Patient vitals were blood pressure 122/72 mmHg, heart rate 70 beats/minute, and SpO2 97%. Patient stated he felt good and reported no earlier symptoms. Patient educated patient on eating before his second dose appointment. At 1134, patient left facility to self with unlabored respirations and steady gait.
29 2021-05-03 numbness Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient felt numbne... Read more
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient felt numbness on right forearm several minutes after the vaccination. It was very mild and came and went for several days. I'm confused because patient stated first shot was in right arm but our records show he received on the left arm. Didn't report any symptoms. He did nothing for the numbess. He said it was barely noticeable. After a couple days, it went away completely.
29 2021-05-04 hot flush, seizure After my 2nd vaccine shot I kept getting heat flashes, headaches, felt dazed throughout the time I g... Read more
After my 2nd vaccine shot I kept getting heat flashes, headaches, felt dazed throughout the time I got the shot at noon till I have a seizure a few hours later at work. It took about 4 hours till I got a seizure in reaction to the 2nd covid shot.
29 2021-05-04 numbness Severe pox like rash all over body, swelling in extremities, pain in joints, numbness in fingers
29 2021-05-05 feeling hot, seizure Patient got the 1st dose of Pfizer vaccine at 1:58 pm on 5/6/21. Patient felt slightly dizzy about 3... Read more
Patient got the 1st dose of Pfizer vaccine at 1:58 pm on 5/6/21. Patient felt slightly dizzy about 3 minutes after getting the vaccine. Then he passed out and fell on the floor with seizure for about 5 seconds. He regain conscious and said he didn't remember anything. He also said his stomach felt upset. Later he felt chest tightness and blurry vision. We called 911 at 2:02 pm. They came in at 2:07 pm. They checked the patient's blood pressure. Patient had low blood pressure. He was sweating and felt hot. He didn't eat or drink anything before getting the vaccine. They transferred him to the emergency room for further check-up.
29 2021-05-05 tremor Within two or three minutes minutes of receiving the injection, patient experienced lightheadedness ... Read more
Within two or three minutes minutes of receiving the injection, patient experienced lightheadedness and felt like fainting. Shaking or pulsating sensation felt in the arms and hands, along with sweating and elevated heart rate, lasting for about 10 minutes. Lightheadedness went away after about 30 minutes.
29 2021-05-06 feeling hot Patient finished 15 minutes of observation time and was in his car about to leave when patient becam... Read more
Patient finished 15 minutes of observation time and was in his car about to leave when patient became very warm and nauseous. Patient walked back into clinic and began to throw up and develop a headache. Patient sat down and blood pressure was taken which was noted to be slightly high (160/72). Patient initially did not want to go to the hospital. However, another 10 minutes went by and patient began to throw up again. Patient agreed to call an ambulance and be checked out by the hospital. 911 was called. Patient did not have a reaction to his first dose of Pfizer COVID vaccine.
29 2021-05-07 muscle spasms, weakness Around 4 AM I started to experience a fever of 101.2, full body weakness, trouble walking, muscle sp... Read more
Around 4 AM I started to experience a fever of 101.2, full body weakness, trouble walking, muscle spasms, irritability, and chills. It was a very strange experience. I took 3 Tylenol at about 7 AM and symptoms started to alleviate around 8:30 AM. The rest of the day I had random body aches, chills, and fatigue. I felt 100 percent by 10 PM on 5/7/2021
29 2021-05-09 hot flush, flushing Pt c/o flushing/sweating, dizziness, hot flashes. BP 96/51, HR 83, RR 16 -- > 116/80, 83. Patient ... Read more
Pt c/o flushing/sweating, dizziness, hot flashes. BP 96/51, HR 83, RR 16 -- > 116/80, 83. Patient stable and released from vaccination site.
29 2021-05-09 myelitis transverse Transverse myelitis
29 2021-05-09 restless legs syndrome, pain in extremity On 07May21 at 11:00PM, I experienced an immense pain on both of my arms that I've never experienced ... Read more
On 07May21 at 11:00PM, I experienced an immense pain on both of my arms that I've never experienced before in my life. Every time I move my arms, fingers, or apply any amount of pressure on any part of my arms, I will get a surge of pain raining down on my arms and only my arms from the shoulder down. At the same time, I also felt a surge of energy/adrenaline flowing throughout my legs, from the pelvis down, urging me to move around. I tried to force myself to sleep (without medication, just forcefully closing my eyes and trying to sleep) to no avail, so I got up and walked around my room and did some leg squats exercises without moving my arms too much from 11:10PM till 3:10AM, (I think getting my blood pumping throughout my body helped ease the pain a bit). The intensity of the pain on my arms decreased about half at around 3:10AM and I was finally able to fall asleep at around 3:30AM. I woke up once at around 7:45AM to go to the bathroom and drink some water. During this time, I think the intensity of the pain had dropped to 1/3 from when I first experienced this pain. I fell back asleep again and woke up at around 11:20AM. Most of the pain is gone by now, I only felt the lingering stings of the dreadful night from before. I continued to feel this phantom pain on both of my arms throughout the day and it wasn't until the day afterwards on the morning of 09May21 that relief was finally bestowed upon me.
29 2021-05-11 weakness, feeling cold 12 hours after vaccine began chills and aggressive shivering that lasted multiple hours. Lethargic, ... Read more
12 hours after vaccine began chills and aggressive shivering that lasted multiple hours. Lethargic, inability to sleep over an hour at a time. First Temperature check at roughly 13 hours from vaccine 102. 1000mg Tylenol taken. Temperature drops to 100 an hour or so later but jumps back to 102 a few hours later. 4 hours after first Tylenol dose took another 1000mg. Same outcome as before but Temperature spiked to 103.4 at about 26 hours post vaccine. Still very lethargic, no appetite since onset of symptoms. Headache, head feels weird when bending over. 36 hours post vaccine Temp raises to 103.8, another 1000mg Tylenol taken. Next five hours spent being cold yet sweating. 42 hours post vaccine Temp returns to normal. Rest of day feeling weak and head feeling odd when making quick movements.
29 2021-05-11 weakness, pain in extremity It started with arm pain at night. And then at 1am I woke up with chills. I fell asleep and woke up ... Read more
It started with arm pain at night. And then at 1am I woke up with chills. I fell asleep and woke up at 5am with severe fever. Fever was all day. I also felt weak, fatigued, dizzy, headache. Took Advil for most of the day. Took Tylenol at night. Took lots of fluids. Was in bed trying to sleep all day. Feeling good now the day after.
29 2021-05-13 tingling pt felt fine immediately after getting Pfizer Covid vaccine, but passed out in the aisle within 5 to... Read more
pt felt fine immediately after getting Pfizer Covid vaccine, but passed out in the aisle within 5 to 10 minutes after receiving vaccine. Didn't administer epipen, but called 911 and had paramedics on the scene quickly. Paramedics started IV, monitored BP, and checked BS. Pt stated hands felt tingly and almost lost consciousness more than once. Ambulance arrived on scene and took pt to hospital.
29 2021-05-14 pain in extremity Fell unexpectedly; I injured my nose, tooth; I injured my nose, tooth; My arm pain is 7 out of 10; s... Read more
Fell unexpectedly; I injured my nose, tooth; I injured my nose, tooth; My arm pain is 7 out of 10; scared to get up.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 28Apr2021 at 16:15 (at the age of 29-years-old) as a single dose in the left arm for COVID-19 immunisation and ibuprofen (ADVIL) from an unspecified date to an unspecified date at an unspecified dose (2) and frequency for an unspecified indication. Medical history included anxiety/depression (mitigated with SSRI) from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known drug allergies. Concomitant medications (taken within 2 weeks of vaccination) included escitalopram orally taken for an unspecified indication from an unspecified date to an unspecified date at 10mg, daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration an unspecified date as a single dose for COVID-19 immunisation. On 29Apr2021 at 03:00 the patient experienced fell unexpectedly, I injured my nose, tooth, my arm pain is 7 out of 10 and scared to get up. The course of events was reported as follows: "Got up at 3am in the morning to take some Advil. Took 2 Advil then fell unexpectedly. Partner was awake and stated that I did not trip on anything. I did not have any previous dizziness or indications that I was going to faint (no night sweats, no stars or blurry vision, no muscle weakness). I injured my nose, tooth (no significant damage), and was scared to get up. My arm pain is 7 out of 10. I have no previous medical history of fainting after a vaccine." No treatment was received for the adverse events. The clinical outcomes of the events fell unexpectedly, I injured my nose, tooth, my arm pain is 7 out of 10 and scared to get up were recovered/resolved on an unspecified date in 2021. 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.
29 2021-05-14 pain in extremity 2nd dose on 5.15.21 at 5 am reports he has pain and swelling in left arm, more so in his left ... Read more
2nd dose on 5.15.21 at 5 am reports he has pain and swelling in left arm, more so in his left hand and digits. He was given Ibuprofen and calling medical professional
29 2021-05-16 numbness, tingling Pt reported numbness, tingling in hands, anxiousness, and syncopal episode in personal vehicle in po... Read more
Pt reported numbness, tingling in hands, anxiousness, and syncopal episode in personal vehicle in post-vaccination waiting area. Pt then walked to EMS staff in waiting area . Second syncopal episode witnessed by EMT.
29 2021-05-16 pain in extremity 1. Sore arm for 2 days 2. Mild fever for 1 day (99.1 F) 3. Mild chest discomfort / shortness of bre... Read more
1. Sore arm for 2 days 2. Mild fever for 1 day (99.1 F) 3. Mild chest discomfort / shortness of breath for 3 days 4. Mild headache for 2 days 5. Fatigue for 2 days 6. Mild stomach ache for 1 day
29 2021-05-16 tingling, tremor, feeling hot, cold extremities, slow speech 5/15/21 @1200: Gammaplex IV infusion started 1320: pt rang call bell for assistance, RN entered room... Read more
5/15/21 @1200: Gammaplex IV infusion started 1320: pt rang call bell for assistance, RN entered room to see pt shaking uncontrollably, pt reports that he is not feeling well, infusion stopped, and PIV flushed, VS obtained BP: 95/66 HR: 104 Temp: 100 RR: 24, Anaphylaxis kit retrieved, DON on phone assisting with walking through Anaphylaxis reaction needs/protocol 1325: 25mg (0.5mL) of Diphenhydramine given via SIVP, PIV flushed with 3mL NS post Diphenhydramine SIVP, manual BP taken at this time BP reading of 120/78 but really hard to obtain an accurate BP d/t pt shaking, Temp: 100 RR: 23, pt continues to shake, hands are cold to touch, finger tips are white with no cap refill noted, purple areas noted around pts knuckles at this time, pt reports that his feet feel tingly at this time and possibly his fingers, states that his back has a warm sensation and that he has a light feeling, pt reports feelings of being nauseated, garbage can provided for patient 1340: no improvement noted from 1st Diphenhydramine dose given, 2nd dose of 25mg (0.5mL) Diphenhydramine given via SIVP at this time, 3mL NS flushed post med, Acetaminophen 325mg x2 tabs that was dispensed for pre-med that pt declined to take was administered PO at this time, BP: 110/64 HR: 104 Temp: 101 RR: 23, continued body shakes noted, hands continued to be cold to touch with fingertips being white noted, no cap refill noted, purple areas still noted around knuckles of hands, pt still reports a warm sensation to his back, pt communicating with eyes closed most of the time, face coloring is pale 1345: pt reports that he feels like he is going to vomit at this time, pt vomited x 3 times into garbage can, 500mL Normal Saline bag per Anaphylaxis order begin at this time, rice pack heated and provided to pt for hand warming, hands continue to be cold to touch, pt continues to keep eyes closed, face continues to be pale 1347: pt reports feeling a little better at this time, lungs clear in all lobes bilaterally to auscultation, tachycardia noted via palpitation and auscultation, pt states at this time that his back does not feel as bad, color is starting to return to pt face at this time, hands continue to be cold to touch with white fingertips noted 1350: BP: 114/72 HR: 100 Temp: 101.9 RR: 20, pt breathing has decreased, pt reports that he feels like he is feeling better, pt discussed with me again that his provider stated that there was not enough information on time frame in between getting the COVID vaccine and his infusion, he also went on to report that he also spoke with another provider about getting the COVID vaccine and his infusion and that provider gave him the CDC website for him to read about the recommendations as well, he stated that both his provider and the CDC website stated that there was no recommended interval between the COVID vaccine and IVIG 1358: BP: 118/68 HR: 90 Temp: 101.7 RR: 18, color returned to face at this time, cheeks flushed, hands continue to be cold to touch but color have started to return to fingertips at this time, cap refill noted at 4 seconds, pt reports that he thinks he is feeling better at this time, states he feels that his speech is a little slower than normal, no slur noted, pt eyes are open and pt is alert, improvement in VS noted 1410: BP: 106/64 HR: 96 Temp: 101.7 RR: 18, pt reports feeling much better at this time, pt is holding conversation well and without difficulty, pt denies feelings of nausea, more color return noted to pt fingertips, cap refill noted of 3 seconds, pt reporting feelings of being drowsy at this time, reports that his back feels normal 1420: 500mL NS bag completed, pt reports at this time that he does not wish to restart his IVIG and asks if he can stay in the AIS for a little while because the Benadryl is making him super tired, pt reports that he does not have anyone that could come and drive him home, pt assured that he can stay in the AIS with RN as long as he needs 1445: BP: 104/56 HR: 106 Temp: 101.8 RR: 20, pt resting calmly, eyes were closed upon entering the rm, pt states he feels much better still, denies any new or concern symptoms at this time, states that he is just really tired, fingertip coloring has returned, cap refill less than 3 seconds noted, lungs clear to all lobes bilaterally 1500: pt resting calmly, pt opens eyes upon entrance into pt rm, pt continues to report feeling better just tired, pt denies any needs at this time 1515: no changes noted with pt, continues to rest calmly in recliner in room with eyes closed, opening eyes when rm is entered 1540: pt up to restroom 1545: BP: 104/63 HR: 102 Temp: 101.3 RR: 18, pt reports that he is feeling much better, he reports not feeling as drowsy now and that he feels okay for him to drive home, he denies any new symptoms, pt was encouraged to take Tylenol 2 tabs Q4-6 hours for temperature and body aches for the next 24 hours, pt was educated on contacting provider for further IVIG needs and rescheduling, pt educated on going to the ER if symptoms return, pt also educated on monitoring temperature at home 1550: PIV removed with tip intact noted, pt stabilized, all color has returned to hands, pt holding conversations without difficulty 1555: pt escorted out of AIS
29 2021-05-16 seizure 5 minutes after patient received vaccine patient reported he felt like he may have a seizure. He the... Read more
5 minutes after patient received vaccine patient reported he felt like he may have a seizure. He then had full body convulsions for about 5 seconds and then fainted. He was assisted to the floor by a staff member. He remained unconscious for approximately 15 seconds per the nurse monitoring the clinic. Patient received a dose of epi and albuterol inhaler. He felt nauseated after, but quickly improved. EMS was called to transport, patient declined and was taken to ER by private care, significant other to drive.
29 2021-05-17 flushing Pt had episode of syncope, flushing/sweating & Dizziness. BP 109/62; HR 74; RR 16. Hx of fainting f... Read more
Pt had episode of syncope, flushing/sweating & Dizziness. BP 109/62; HR 74; RR 16. Hx of fainting from blood draws. MD saw pt & pt stable ok to leave vaccination site
29 2021-05-18 grand mal seizure Numerous grand mal seizures, never before experienced,, including 2 instances of status epilepticus.... Read more
Numerous grand mal seizures, never before experienced,, including 2 instances of status epilepticus. Have had epilepsy since 2012 and current medication levels are in normal range.; Numerous grand mal seizures, never before experienced,, including 2 instances of status epilepticus. Have had epilepsy since 2012 and current medication levels are in normal range.; This is a spontaneous report from a contactable consumer reporting for self. A 29-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Apr2021 at 13:30 (Batch/Lot number was not reported) as single dose (at the age of 29 years old) for COVID-19 immunization. There was no other vaccination received in the 4 weeks prior. Medical history included epilepsy since 2012, autism spectrum disorder, respiratory illness in Nov2019 (not caused by the flu but with COVID-like symptoms), high blood cell count (previous treatment). There were no known allergies. Concomitant medication(s) included lamotrigine (LAMICTAL) and escitalopram oxalate (LEXAPRO), both taken for epilepsy, start and stop date were not reported. On 25Apr2021 at 20:30, the patient experienced numerous grand mal seizures, never before experienced, including 2 instances of status epilepticus. The patient has had epilepsy since 2012 and current medication levels were in normal range. There was no treatment received for the adverse event. The events resulted in a Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events grand mal seizures and status epilepticus was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
29 2021-05-18 night sweats I received the 1st shot of the pfizer covid vaccine on March 11, 2021. Within 2 days I began to feel... Read more
I received the 1st shot of the pfizer covid vaccine on March 11, 2021. Within 2 days I began to feel extremely fatigued. The days following I experienced night sweats, nausea, extreme fatigue, fever. I went to urgent care with a 102 fever, jaundice, and anemia. Urgent care sent me to the ER. At the ER they admitted me to the hospital. I was in the hospital for 3 days with hemolytic anemia. After a lot of testing and ruling out any infections, they discovered I have a rare blood disorder: hereditary elliptocytosis. The pfizer vaccine created an immune response and since I have this blood disorder I was predisposed to this event occurring from the vaccine (hemolytic anemia/juandice) without knowing it. It was a result of the vaccine. I was told to not get the second shot because there is no guidance, but that I am a high risk individual now. I need medical advice from people who are familiar and know.
29 2021-05-19 flushing, feeling hot Similar to covid infection; Similar to covid infection; Shock sensation on different locations of th... Read more
Similar to covid infection; Similar to covid infection; Shock sensation on different locations of the body; Could not eat or drink; Feeling weird; Heart beat went up; Tensed; Pink warm face; Flushing of the skin for about 20 mins; Pink warm face/feeling warm; Drank water and then it went away somewhat like after drinking alcohol; Butterflies sensations in the throat; This is a spontaneous report from a contactable consumer. A 29-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's 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 unspecified date as single dose for COVID-19 immunisation. It was reported that the patient (male, 29 years old) had COVID and then took vaccine and experienced similar side effects like next morning could not eat or drink, feeling weird, heartbeat went up, tensed, pink warm face, flushing of the skin for about 20 mins, feeling warm, drank water and then it went away somewhat like after drinking alcohol. The patient again felt different sensation, butterflies sensations in the throat, heart rate went up, shock sensation on different locations of the body and taking deep breathing. It lasted for about 3-4 days. The outcome of events was recovered/resolved. Information on the lot/batch number has been requested.
29 2021-05-19 seizure Patient had a syncope episode followed by a period of decreased breathing and a seizure. Patient was... Read more
Patient had a syncope episode followed by a period of decreased breathing and a seizure. Patient was given 0.3 mL EpiPen in right anterior thigh and 2-dose Albuterol 90mg. 911 dispatched. Patient declined transport. Instead, transported by personal vehicle with wife. Was seen at the hospital.
29 2021-05-19 tremor Patient presented to Observation check in area (@ 4:20 PM) appearing shaky, diaphoretic and was comp... Read more
Patient presented to Observation check in area (@ 4:20 PM) appearing shaky, diaphoretic and was complaining of being lightheaded. Patient was assisted to sit in a wheel chair and wheeled back to treatment area where he was assisted again onto the cot to lay down. Patient history was obtained while he was inside treatment area. Pt denied Medication and Food Allergies as well as any Past Medical History. Patient was given water to drink and stated he felt normal again, wanted to and was ready to leave 5 minutes later at 4:25 PM.
29 2021-05-20 tingling Pt developed "head rush" then tingling feeling in legs after vaccination, also felt like he wanted t... Read more
Pt developed "head rush" then tingling feeling in legs after vaccination, also felt like he wanted to cry. Denies chest pain, SOB, trouble breathing or swallowing. Pt discharged home in stable condition. SpO2 98% RA BP 132/81 HR 84 Respirations 18, unlabored.
29 2021-05-21 bell's palsy Have been diagnosed with Bell's Palsy due to a facial paralysis; This is a spontaneous report from a... Read more
Have been diagnosed with Bell's Palsy due to a facial paralysis; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 23Apr2021 11:00 (Lot Number: EW0171) as 2ND DOSE, SINGLE for covid-19 immunisation. No known allergies and other medical history. The patient concomitant drugs were not reported. The patient previously received first dose of BNT162B2 on 02Apr2021 12:00 am in left arm (lot number: ep7534). 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 had been diagnosed with Bells Palsy due to a facial paralysis on 04May2021 12:00 AM. Unknown if it was related to the vaccine or the cause. The adverse event result in emergency room/department or urgent care. Currently taking prescribed medication for event. The outcome of event was recovering.
29 2021-05-23 nerve pain Pt states the day after he received the vaccine, pt teeth hurt and he was having lung pain. Pt also ... Read more
Pt states the day after he received the vaccine, pt teeth hurt and he was having lung pain. Pt also stopped smoking the day he received the vaccine. Pt is unsure if symptoms are related to incident. Pt lung pain has resolved. Pt states that 2 days after he received the vaccine, he complains of hand nerve pain, with his middle and ring finger. The nerve pain is still present. Pt also complains about after getting the vaccine, days later that patient complains of foot/nerve pain. Pt was shot with a bullet in past and had nerve pain before in similar spot and it has returned after receiving the vaccine. Bullet fragments are still in patient.
29 2021-05-23 night sweats High fever, chills, muscle aches, night sweats, nausea, vomiting, headache. Persisted for 3 days.
29 2021-05-24 numbness Left arm pinky and ring finger are numb. Any pressure put onto the arm causes the numbness intensity... Read more
Left arm pinky and ring finger are numb. Any pressure put onto the arm causes the numbness intensity to increase. Circulation doesn't improve numbness, it's always there at some level.
29 2021-05-24 pain in extremity Pain in arm, headache, temporary backpain
29 2021-05-25 weakness tiredness; weakness; headache; muscle pains; feeling unwell; stomachache; heavy breathing; This is a... Read more
tiredness; weakness; headache; muscle pains; feeling unwell; stomachache; heavy breathing; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 19Feb2021 at 10:45 (Lot Number: EL9266) (at the age of 29-year-old) as single dose for COVID-19 immunisation. Medical history included type 1 diabetes and penicillin allergy, both from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not tested positive for COVID-19. Concomitant medications included insulin and sertraline hydrochloride (ZOLOFT), both taken for an unspecified indication, start and stop date were not reported. On 19Feb2021 at 11:30, the patient experienced tiredness, weakness, headache, muscle pains, feeling unwell, stomachache and heavy breathing. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
29 2021-05-25 slurring slurred speech; Memory loss; loss of cognitive functions; increased appetite; nausea; headaches; wei... Read more
slurred speech; Memory loss; loss of cognitive functions; increased appetite; nausea; headaches; weight gain; unable to stay focused; shortness of breath / difficulty breathing; chest pain near heart; This is a spontaneous report from a contactable consumer or other non hcp. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0162) unknown dose via an unspecified route of administration in deltoid left on 15Apr2021 at 01:45 (at the age 29 years) as single dose for COVID-19 immunization. Medical history included depression. The patient's concomitant medications were not reported. 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: Allergy medicine, ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Apr2021 at 16:00, the patient experienced memory loss, loss of cognitive functions, increased appetite, nausea, slurred speech, headaches, weight gain, unable to stay focused, shortness of breath, difficulty breathing, chest pain near heart. Outcome of the events was recovered with sequelae. No follow up attempts are possible. No further information is expected.
29 2021-05-25 hot flush AE: rosey smell, hot flashes, feeling nervous/ anxious(at 10:20am) treatment: n/a ; food and drink h... Read more
AE: rosey smell, hot flashes, feeling nervous/ anxious(at 10:20am) treatment: n/a ; food and drink helped, ate crackers and drank juice. outcome: felt better after eating crackers, patient discharged home
29 2021-05-25 night sweats I had covid 19 back in March of this year. I am experiencing similar side effects. Headache Aches C... Read more
I had covid 19 back in March of this year. I am experiencing similar side effects. Headache Aches Chills Brain fog Tiredness Night sweats
29 2021-05-25 pain in extremity The first day I got the vaccine, my arm became very sore about 4 hours afterward. It kept getting mo... Read more
The first day I got the vaccine, my arm became very sore about 4 hours afterward. It kept getting more sore until I fell asleep. I stretched and massaged it. The next day (Sunday), I woke up to a small canker sore in the left side of my mouth behind my top lip. It is right by where my canine and lateral incisor intersect. I thought nothing of it since I do occasionally get canker sores. As the day went on, the pain increased. I also noticed that two more sores had appeared. One on my lower lip right below where the original one is, and on my gums near my throat, like right where the gums end and throat begins. All on the left side. I got the shot in the left arm. They're all more painful than usual, but the first one is the worst and is the biggest one I've ever had. Normally if I get one (like once every other month) the canker sore is small, white, and hurts if I touch it. The one behind my top lip is causing my lip to be noticeably swollen when I open my mouth, and it's definitely left a crater. I can't brush my teeth near where it is because it feels like I'm ripping out my flesh. In addition, a submandibular node feels weird. It's not quite painful, but it's definitely a weird sensation that is noticeable at all times. I started feeling it one day after the vaccine, and today (two days after) the feeling is much more pronounced. I have not seen a doctor since it seems like others have had these side effects, and they went away after a couple days. I just wanted to provide more data since it's definitely not the most comfortable thing right now.
29 2021-05-25 tremor, feeling of body temperature change, hot flush, pain in extremity After a few hours of receiving the vaccine, I could start to feel soreness in my left armpit (lymphn... Read more
After a few hours of receiving the vaccine, I could start to feel soreness in my left armpit (lymphnode). This moved to all of left arm even all left side of body. Began feeling very tired. Less than 12 hrs after receiving 2nd dose I had to leave work early. 3:30 am the next morning I had uncontrollable shivers/tremors. To the point where I couldn't stand on my own. I had a fever of 101 degrees. As a result of the tremors I had entire body soreness. Hot flashes; alternating from sweat to freezing. Side effects began to dissipate after a full 24 hours.
29 2021-05-25 tremor Severe headache, rigors, high fever (subjective), tachycardia, severe nausea. Drenching sweats, "str... Read more
Severe headache, rigors, high fever (subjective), tachycardia, severe nausea. Drenching sweats, "strange thoughts". Rigors and drenching sweats throughout the night. "Crazy shaking fits." Presyncope. Got to point where patient considered calling ambulance. Lasted 12 hours then fully resolved.
29 2021-05-28 pain in extremity cold symptoms; My arm is sore; feel congested like when I get sick; This is a spontaneous report fro... Read more
cold symptoms; My arm is sore; feel congested like when I get sick; This is a spontaneous report from a non-contactable consumer (patient) via Medical information team. A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 19May2021 (at the age of 29-years-old) at first dose, single for COVID-19 immunization. Medical history included allergies. The patient's concomitant medications were not reported. The patient reported that he had cold symptoms. He thought he had allergies before the shot because he would usually get them about this time of year and it would start to act up. The patient's arm was also sore and felt that it was something he had before the shot because they were kind of similar and he just felt congested like when gets sick. Additionally, the patient wanted to know how long he has to wait to take medications like Nyquil or Dayquil. The outcome of the events was unknown. Information on the lot/batch number has been requested.
29 2021-05-30 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Additional Details: the next... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Additional Details: the next day patient said he was okay.
29 2021-06-01 cold sweat about 5 minutes after receiving the pfizer vaccine patient became sweaty and skin got clammy and he ... Read more
about 5 minutes after receiving the pfizer vaccine patient became sweaty and skin got clammy and he felt like he was going to faint. He lost all color to his face. Blood pressure was taken and it was 92/60. We gave him a cold pack on the back of his neck and had him lay down and elevate his feet and legs. Also got him some cold water to drink. He started to feel better in about 15 minutes after that. We continued to monitor blood pressure about every 5 to 10 minutes and it got to 99/72 and last check was 120/65. He did not want the ambulance or to go to urgent care. We told him to take it easy the rest of day and to have somebody with him til next morning. And then he and his friend left to go to his parents house.
29 2021-06-01 pain in extremity After I received the vaccine my left arm hurt real bad for about 50 days to lift or move. I went to... Read more
After I received the vaccine my left arm hurt real bad for about 50 days to lift or move. I went to the ER one day because of the pain and was prescribed pain medication.
29 2021-06-03 pain in extremity Somewhat sore arm and protruding swollen lymph node on left collarbone.
29 2021-06-05 seizure, seizure, unresponsive to stimuli, unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Additional Details: patient fell d... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Additional Details: patient fell down and apper to have seizure , we called emc ,emc take care of the pt, and he was ok,pt refuse to go to er.
29 2021-06-07 difficulty speaking Date added: 06/05/2021 at 10:29 AM (MDT) Patient wants to be seen for covid symptoms. Experiencing h... Read more
Date added: 06/05/2021 at 10:29 AM (MDT) Patient wants to be seen for covid symptoms. Experiencing headaches, dry cough, congestion, only thing he does not have is fever and chills. Been going on for a week now. Started with the COVID vaccine that was received last Friday been sick since last Saturday. onset week ago, 5/28 he received covid vaccination pfizer first dose - from CVS and developed same evening headache congestion now has neck pain for 2-3 days, 3/10, worse with nothing not worse with movement and has full rom, no fever or chills but has dry cough, and congestion and raspy voice, has headache slight headache, back of head 7/10, daily headache for a week now, and has lightheadedness when stands up for a week, headache is worse with activity, and worse when lays down, taking tylenol and ibuprofen and dayquil and nyquil but headache recurs and only slightly improved by medication. has no PCP had covid19 illness July 2020
29 2021-06-08 muscle twitching -Head ache lasting almost all day. No particular region of the head -Started 06/01~ 06/02 . Persis... Read more
-Head ache lasting almost all day. No particular region of the head -Started 06/01~ 06/02 . Persistent upto now 06/09. - Taking ~ 75 mg Aspirin 1 X day, since 05/06. Pain intensity is lower now. -Patient has minor history of muscle twitching , no particular history of head ache - Will consider visiting primary care physician , if pain doesn't subside in the next few days
29 2021-06-10 weakness This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old male patient r... Read more
This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP6955; Expiration date was not reported), via unspecified route of administration on an unspecified date in Mar 2021 (reported as 10:00 AM) (at the age of 29-years-old) as first dose, single dose for COVID-19 immunization. Medical history included COVID-19 (COVID prior vaccination) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not tested for COVID post vaccination. The patient has no known allergies. On an unspecified date in Mar 2021 (reported as 04:00 PM), the patient experienced heavy fatigue, weakness and pain at injection site. No treatment was taken for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
29 2021-06-12 flushing Patient got the vaccine around 12:45pm. At around 1 pm, the patient fainted for about 7 seconds and ... Read more
Patient got the vaccine around 12:45pm. At around 1 pm, the patient fainted for about 7 seconds and fell out of the chair in the waiting room. I ran outside of the pharmacy to assist him. He was conscious but confused for a few moments. Then said he felt fine. Patient showed no signs of allergic reaction. I asked him if he had any injuries/bleeding and he said no. I asked him to stay at the pharmacy for another 30 minutes so I could observe him closely. We gave him a cup of cool water to sip on. At around 1:10 pm, I went outside the pharmacy to check on him again and he said he felt flushed and asked for a bucket. At 1:15 pm, he vomited into the bucket. He said he felt 100% better after vomiting. I had him stay at pharmacy until shortly after 1:30 pm when he said he felt okay to go home. I called him at home around pm the same day and he said he felt fine.
29 2021-06-13 weakness Swollen lymph nodes within 5 minutes. After 3 hours, malaise, dizziness, fatigue, weakness, chills,... Read more
Swollen lymph nodes within 5 minutes. After 3 hours, malaise, dizziness, fatigue, weakness, chills, nausea. Symptoms worsened over the past 10 days. Uncontrollable and inexplicable panic attacks, debilitating episodes of sickness.
29 2021-06-13 burning sensation At the time of injection, he experienced a burning sensation immediately from the injection site to ... Read more
At the time of injection, he experienced a burning sensation immediately from the injection site to the fingers. The burning lasted a few minutes. He then was standing waiting for his wife to receive her vaccine. He became dizzy and diaphorectic. He passed out for a moment. I kept him in the chair and monitored his breathing and tried to keep him alert and responding to my questions.
29 2021-06-13 feeling cold, tremor really cold and joint pain everywhere and minor shakes
29 2021-06-14 feeling hot, muscle twitching Directly after administration of the vaccine, the patient started to feel like he was going to faint... Read more
Directly after administration of the vaccine, the patient started to feel like he was going to faint and became nauseous. I got him some water and when I returned he was slouched in his chair. His leg and arms started to twitch for at least 10 seconds and he was incoherent. After the twitching stopped, he seemed to not have full recollection of the past minute and asked if he had passed out. His shoulder muscles were tight, he felt very warm, and soon after become nauseous but did not vomit. We gave him an ice pack to cool him down in addition to the cold bottle of water. We waited for a friend to come pick him up and during the wait he recovered and was able to hold a conversation, not feel dizzy, and stand up on his own. After 30 minutes of observation, the friend arrived so I walked with him out of the pharmacy to the car.
29 2021-06-16 weakness Still feeling dizzy; Dizzy; Not able to concentrate on his work; Weakness; This is a spontaneous rep... Read more
Still feeling dizzy; Dizzy; Not able to concentrate on his work; Weakness; This is a spontaneous report from a contactable consumer (patient himself). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), intramuscularly in right arm on 01Jun2021 (at the age of 29-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), intramuscularly in right arm on 12May2021 (at the age of 29-year-old) as a single dose for COVID-19 immunization and had fever. The patient did not receive any other vaccines 4 weeks prior to COVID-19 vaccination. It was reported that, patient stated, he had his second dose of COVID Vaccine like 12 days ago. So he was still feeling dizzy on an unspecified date in 2021, and he was not able to concentrate on his work on an unspecified date in 2021. So he just wanted to know how long it would last. Patient stated that he experienced side effects mostly after the second shot. Patient had ibuprofen after the vaccine. Patient was still experiencing dizzy and was not able to concentrate on his work. Patient experienced only dizzy, weakness on an unspecified date in 2021. No investigation assessment. The outcome of the events was unknown.
29 2021-06-16 numbness Adverse Events: Severe Loss of Breath; Numbness in Extremities; Chest Pain; Heart Palpitations; Fain... Read more
Adverse Events: Severe Loss of Breath; Numbness in Extremities; Chest Pain; Heart Palpitations; Fainting; Dizziness Treated with Oxygen and High Dose of Benadryl at hospital. Returned home roughly 4 to 5 hours after treatment.
29 2021-06-16 pain in extremity I think the second time it is like some Arm Pain; This is a spontaneous report from a contactable co... Read more
I think the second time it is like some Arm Pain; This is a spontaneous report from a contactable consumer (patient himself). A 29-year-old male patient received 2nd dose of bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection), via intramuscular route of administration, administered in arm right on 03Jun2021 (Lot number: EW0180) (at the age of 29-year-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection, Batch/Lot Number: EW0179), via intramuscular route of administration, administered in arm right on 10May2021 as 1st dose, single dose for covid-19 immunisation and experienced left me with some type of hardness on my skin, muscle ache, tiredness and arm pain. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine because patient was really skeptical about vaccine. The patient confirmed that he had taken both the shots. On an unspecified date, the patient reported that "I think the second time it is like some Arm Pain". He thought he had doubt after seeing all this stuff all over the news and talk this hard stuff and potentially putting the life in danger. He did not receive any treatment for the events, he just rested. At the time of reporting, the outcome of the event was unknown.
29 2021-06-16 pain in extremity Sore arm after first dose; This is a spontaneous report received from a contactable consumer, the pa... Read more
Sore arm after first dose; This is a spontaneous report received from a contactable consumer, the patient. A 29-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot number: EP-6955), via an unspecified route of administration on an unknown date (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient had experienced sore arm after first dose. The clinical outcome of the event sore arm after first dose was unknown. No follow-up attempts are needed. No further information is expected.
29 2021-06-17 numbness to the ED on 4/30, with an ECG and symptomatology consistent with pericarditis, no official diagnosi... Read more
to the ED on 4/30, with an ECG and symptomatology consistent with pericarditis, no official diagnosis sent home on indomethacin. Cardiology 5/4 with the ongoing diagnosis of atypical pericarditis sent home. return to the ED 5/9. No definitive pericarditis diagnosis R/T vaccine admin. did experience Left sided numbness upper/lower extremity which was worked up with unclear etiology
29 2021-06-21 tingling Pt getting shot felt tingling 30 seconds after then nausea and lightheaded. He got stiff, gasped and... Read more
Pt getting shot felt tingling 30 seconds after then nausea and lightheaded. He got stiff, gasped and passed out. Per pt, he had a "hallucination". Pt experienced LOC for approx 5 seconds, he "took a deep snort" and came back. Pt pale and diaphoretic, vomited and moved to med obs 1. VSS. Resolution of symptoms within 20 minutes, and released.
29 2021-06-22 pain in extremity First day after had sore arm and 101 fever. Woke up next day and fever was gone, then went to sleep ... Read more
First day after had sore arm and 101 fever. Woke up next day and fever was gone, then went to sleep and high fever came back ranging between 102 and 103.5 for the next 4 days. Had difficulty urinating due to inflamed prostate and UTI and fever that only lowered mildly from medicine
29 2021-06-22 tingling, feeling hot PATIENT BEGAN WITH FEELING HOT AND A HEADACHE. PATIENT WAS GIVEN A COOL RAG TO PLACE ON HIS HEAD AND... Read more
PATIENT BEGAN WITH FEELING HOT AND A HEADACHE. PATIENT WAS GIVEN A COOL RAG TO PLACE ON HIS HEAD AND NECK. PATIENT THEN CONTINUED TO HAVE SHORTNESS OF BREATH DESCRIBED AS A KNOT IN HIS CHEST. HE WAS GIVEN 10ML OF BENADRYL, THEN VOMITED A FEW MINUTES LATER. BENADRYL AND COLD WATER WAS ADMINISTERED AGAIN. THEN HE STARTED FEELING TINGLY IN HIS RIGHT ARM. THEN TIGHTNESS IN HIS ENTIRE CHEST. THIS LASTED OVER AN HOURS TIME FRAME. BEGAN AT 8 MINUTES AFTER ADMINISTRATION.
29 2021-06-24 myelitis transverse Pt reported progressive neuro deficits, was seen by a neurologist and reports a diagnosis of Transve... Read more
Pt reported progressive neuro deficits, was seen by a neurologist and reports a diagnosis of Transverse Myelitis that he reports was attributed to the covid vaccine by his provider.
29 2021-06-26 myelitis transverse, numbness, muscle spasms, burning sensation, tingling, nerve injury Muscle weakness, nerve damage, burning in legs, numbness/tingling in legs, numbness/tingling feet an... Read more
Muscle weakness, nerve damage, burning in legs, numbness/tingling in legs, numbness/tingling feet and hands and arms, severe cramping - cannot walk for more than a few minutes. Treatment will involve Solumedrol steroid injections, Tizanidine muscle relaxers, and Meloxicam inflammatory medication.
29 2021-06-28 discomfort Day after vaccine, I was sick all day. Hard to breathe; heart rate would shoot up and then come down... Read more
Day after vaccine, I was sick all day. Hard to breathe; heart rate would shoot up and then come down in one minutes sessions; I had body aches - all over. Doing anything felt painful. Eating was uncomfortable and sitting was uncomfortable. I had some fever. 238.5 Celsius and it got a little worse during the day (and that number is the end of the day). I had some pain in the chest, too - center of chest. I also had a headache throughout the day. I did a televisit (wednesday) and she advised to take acetaminophen for fever. She said my blood pressure was fine and my heart rate was still under 100 most of the time. The next day, everything seemed fine - all symptoms seemed to go over night except heart rate - still was elevated and the difficulty breathing was still there. Even sitting - my breathing and heartrate felt like it was working. Friday, things were mostly similar - heart rate came mostly down. But end of day, difficulty breathing came worse and chest pain became worse and tightening of chest was more intense. No fever after Wed though. I went to see the Urgent Care doctor at Urgent Care. Friday, the second week after the vaccine, the symptoms received. Pain in left arm started (started Tuesday or Wed the second week) and I had chest pain and tightness in the chest and slight difficulty breathing, nausea, dizziness and no fever. ER - on Saturday - 11:30PM - they did more tests - everything heart related came back fine so they ruled out Heart attack; but didnt' know what it was; gave medication for nausea in case it would help. IV medication and then one medicine to drink on the spot. It didn't really help - the symptoms continued and slowly disappeared the next day (the second Sunday after the vaccine). Nothing new since then.
29 2021-06-29 pain in extremity Felt like had torn muscles in shoulder--intense pain / sudden pain; Limited range of motion, without... Read more
Felt like had torn muscles in shoulder--intense pain / sudden pain; Limited range of motion, withoutany muscles feeling tense or locked up; Sore arm; Pain and sensation continued to worsen in my arm and shoulder, until it spread to my spine; spine hurt more and more; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6202) via unspecified route of administration in left arm on 17Mar2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not received any other medications in two weeks prior to vaccination. On 18Mar2021, the patient started the morning after vaccine, with just a sore arm (pain in arm). The second day after the vaccine, it felt like the patient had torn muscles in shoulder--intense pain (shoulder pain) and limited range of motion, without any muscles feeling tense or locked up (movements reduced). The third day, pain and sensation continued to worsen in arm and shoulder, until it spread to spine (condition worsened). By the end of the night, arm started to feel okay but spine hurt more and more (pain in spine), feeling like it had a compression injury. It was reported that, the patient that if he had no memory, and someone told he had been in a car accident, or compressed his spine by jumping from 30 feet in the air, he would readily believe it. It was the fourth morning as the patient wrote, and spine still felt same way. No physical activity or other explanation for sudden pain, no prior history of injury/pain for these areas. It was unknown if the patient had received any treatment for the events. The outcome of the events shoulder pain, movements reduced, condition worsened, pain in spine was not resolved and for event pain in arm was resolving at the time of this report. No follow up attempts are needed. No further information is expected
29 2021-07-04 pain in extremity, feeling hot 5/10 min after shot I started sweating profusely and y body temp felt really hot, I then started fee... Read more
5/10 min after shot I started sweating profusely and y body temp felt really hot, I then started feeling faint and my vision went blurry and I had stabbing pains in both arms. This lasted 10 minutes and was extremely uncomfortable, by the time medics reached the scene I was okay and the only symptom that remained was the stabbing pains.
29 2021-07-08 pain in extremity There is a small, weak, shooting pain in my chest around the area of my heart. It lasts for about ha... Read more
There is a small, weak, shooting pain in my chest around the area of my heart. It lasts for about half a minute to a full minute before dispersing. It rarely happens and so far, it has been about once daily. My left arm is also experiencing a weak, dull pain on the outer side of my bicep. It starts in the middle and goes down to the elbow. It sticks around for a while but it did not start until 07/09/2021.
29 2021-07-08 pain in extremity Next morning woke up shaking chills; Feeling feverish but no fever; Arm sore immediately following s... Read more
Next morning woke up shaking chills; Feeling feverish but no fever; Arm sore immediately following shot; In evening body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration on 24Mar2021 at 11:30 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. Medical history included obese and blood pressure being monitored. The patient did not have any allergies to medications, food, or other products. Concomitant medication included multi-vitamin (MANUFACTURER UNKNOWN) for unspecified indication started from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021 at 12:00, the patient experienced arm sore immediately following the shot and in the evening the patient experienced body aches. On 25Mar2021 (next morning), the patient woke up with shaking chills and feeling feverish but no fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with TYLENOL. The clinical outcome of the events pain in arm, general body pain, chills and feverish were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
29 2021-07-15 tingling, weakness GBS with ascending polyneuropathy causing paresthesias and weakness treated with IVIG at discharged ... Read more
GBS with ascending polyneuropathy causing paresthesias and weakness treated with IVIG at discharged to rehab had aspiration and worsening weakness again then brought to MGH, requiring intubation
29 2021-07-18 numbness, tingling Patient came today for the first pfizer covid vaccine. Patient fainted as he walked out. Pt has a hi... Read more
Patient came today for the first pfizer covid vaccine. Patient fainted as he walked out. Pt has a history of fainting after a vaccine, gave an example from his previous experience with a vaccine given to him (he did not know the name of the vaccine), claims that he had increased bowel movement, numbness and tingling after that vaccine. Patient had similar reactions today. It seems that his reaction was not specific to the covid vaccine but regardless we had him rest in a private room for 45 minutes before releasing him. We will follow up with him in the next few days.
29 2021-07-18 migraine Severe migraine lasting 12+ hours and reoccurring for the next two days
29 2021-07-19 pain in extremity Soreness in the arm. Skin is sensitive on the left hip. Left calve area is sore.
29 2021-07-19 seizure shortly after the vaccine, the patient had a seizure while sitting on his chair for about 10 seconds... Read more
shortly after the vaccine, the patient had a seizure while sitting on his chair for about 10 seconds and was feeling dizzy. He sipped some water and he felt better. paramedics came to check on him and he was stable.
29 2021-07-26 seizure, tingling Patient experienced nausea, then a seizure 5 minutes after receiving the vaccination. He was inconti... Read more
Patient experienced nausea, then a seizure 5 minutes after receiving the vaccination. He was incontinent and postictal. He remembers his arms tingling and difficulty opening his right hand. Patient went to the ED. His CT scan was negative for bleed. EKG showed sinus bradycardia 48. Patient did have a head injury at the age of 18 but no prior history of seizures. He was discharged but told to follow up with neurology.
29 2021-07-26 unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: patient felt lightheaded after shot. I gave him a water bottle that when he placed on the ground he started to fall over/ lose consiousness. 911 was called immediately. I was able to catch patient and tried lowering him to the ground as he regained consiousness. cold water was also used to cool neck area. ems took patients bp and wrote up report but patient refused to go to ED. fiance was called to drive home/ to go eat after 30 mins to ensure patient was stable, hydrated.
30 2020-12-31 tension headache - Injection site soreness: developed the day after injection and largely resolved after about 24-36 ... Read more
- Injection site soreness: developed the day after injection and largely resolved after about 24-36 hours. - Headache: minor tension headache developed about 48 hours after injection and lasted a little over a day. - Sore throat: mild; developed about 48 hours after injection and continues to persist about 2 days later.
30 2021-01-03 hypersensitivity of all senses 6 day history R sided chest rash w/ skin hypersensitivity consistent with shingles rash. Received co... Read more
6 day history R sided chest rash w/ skin hypersensitivity consistent with shingles rash. Received covid vaccine 1.5 days before. Seen by PMD over telehealth appt and dx with shingles. Had VZV at 5 yo. No prior vaccine for VZV.
30 2021-01-04 flushing Approximately around 1450, 10 minutes after injection, while in monitoring area, employee started c/... Read more
Approximately around 1450, 10 minutes after injection, while in monitoring area, employee started c/o nausea and then began to vomit. He then c/o feeling flushed, itching, headache, chest tightness, and SOB. V/S: B/P 126/82; pulse 103; resp 20; O2 sat 99% on RA; lungs clear upon asculatation; pupils equal and reactive; skin pink. Doctor was notified and assessed the employee 1455 - Doctor ordered Benadryl 50mg IM which was administered to the Left arm by nurse. 1505 - FSBS was 87; O2 sat was 98% on RA; pulse 97 1510 - O2 sat was 98% on RA; pulse 90 1520 - O2 sat was 98% on RA; pulse 98; employee was still vomiting; lungs remained clear 1528 - Employee reported that all symptoms were about the same, but waxing and waning; doctor ordered to give Zofran 4mg SL and this was given by nurse. 1530 - O2 sat was 98% on RA; pulse 90; B/P 122/90 1540 - O2 sat was 96% on RA; pulse was 88. Rechecked on Left hand - O2 sat was 98% on RA; pulse was 94 1545 - Employee reported improvement of headache, itching, chest tightness, flushing, and SOB; however, was still vomiting almost continously 1550 - O2 sat was 99% on RA; pulse 83 1600 - B/P - 118/84; pulse 78; resp 20; O2 sat 98% on RA; Employee still vomiting continously 1613 - Doctor recommended that the employee be evaluated in the ER. A family member/friend was called. Employee was taken to a private vehicle via wheelchair and transported to ER for evaluation.
30 2021-01-04 flushing After vaccination, employee went to the monitoring area. Around 1450, he complained of nausea and t... Read more
After vaccination, employee went to the monitoring area. Around 1450, he complained of nausea and then began to vomit. He then began to c/o flushing, itching, headache, chest tightness, and SOB. Symptoms began approximately 10 min. after immunization. V/S: 126/82; pulse 103; resp 20; O2 sat 99% on RA; pupils equal and reactive. Dr. was notified and assessed the employee. Dr. ordered Benadryl 50mg IM at 1455. This was administed by RN to Left Arm. At 1505, FSBS was 87; O2 sat 98% on RA, pulse 97. At 1510, O2 sat was 98% on RA; pulse 90. At 1520, O2 sat was 98% on RA and pulse 98. Employee continued to vomit. Lungs were clear upon assessment. Skin was pink. At 1528, employee reported that the symptoms were about the same...maybe waxing and waning. Dr. ordered Zofran 4mg SL which was administered at 1528. At 1530, O2 sat was 98% on RA; pulse was 90; B/P was 122/90. At 1540, O2 sat was 96% on RA; pulse 88 - rechecked on Right hand which gave a reading of O2 sat of 98% on RA; pulse 94. At 1545, employee reported improvement of headache, itching, chest tightness, flushing, and SOB; however, was still vomiting almost coninuously. At 1550, O2 sat was 99% on RA; pulse 83. At 1600, B/P was 118/84; pulse 78; resp 20; O2 sat 98% on RA. He continued to vomit. At 1613, employee was taken via wheelchair to private vehicle of a friend and was taken to ER for evaluation.
30 2021-01-04 migraine Migraine 1 day after injection; Headache; arthralgias; myalgia; chills; low grade fever; This is a s... Read more
Migraine 1 day after injection; Headache; arthralgias; myalgia; chills; low grade fever; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 30-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose at left arm for immunization. Medical history was none. The patient's concomitant medications were not reported. Patient didn't 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 had not been tested for COVID-19. The patient experienced migraine 1 day after injection, headache, arthralgias, myalgia, chills, low grade fever on days 1-6 post injection which are improving. Patient received Ibuprofen 400 mg daily for events. The report is considered non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
30 2021-01-04 night sweats Starting the day after I got flu like symptoms. Headache, night sweats, chills. Starting last night,... Read more
Starting the day after I got flu like symptoms. Headache, night sweats, chills. Starting last night, after sweating an obscene amount, I started feeling dizziness. Not a normal dizziness, but a severe one with brain zaps. The type of brain zaps someone has when coming on or off affexor/venlafaxine (which I?m currently on). The dizziness only happens when I stand and the brain zaps happen more frequently than when the dose changes or is forgotten with the snri. Before someone asks... yes... I?m taking my affexor properly and haven?t changed how I?m taking it since my covid shot.
30 2021-01-05 weakness Severe chills and weakness. Ran 6 miles day of getting vaccinated (21st) unable to even reach the e... Read more
Severe chills and weakness. Ran 6 miles day of getting vaccinated (21st) unable to even reach the end of the street on the 22nd.
30 2021-01-05 throat numbness Patient experienced significant swelling of arm, back, and facial region, headache, reports kidney p... Read more
Patient experienced significant swelling of arm, back, and facial region, headache, reports kidney pain and lip and throat numbing, as well as overall body aches. Patient took Benadryl 50mg to reduce swelling with success. Symptoms subsided completely after 4 days.
30 2021-01-06 weakness Body aches, chills, sweating, nausea, and general weakness
30 2021-01-06 flushing Patient stated he was "feeling flushed", observed flushed cheeks, itchy lips, tingling tongue. Had h... Read more
Patient stated he was "feeling flushed", observed flushed cheeks, itchy lips, tingling tongue. Had him sit for vital signs, after a few minutes employee asked if he wanted fresh air and he felt fine enough to walk, she escorted him outside. They came back in after a few minutes and he sat down and drank some water. They retook vital signs and he said he was feeling better. 0742 vital signs 121/79, 02 sat 99, HR 87. 0757 vital signs 119/79, O2- 98, HR 77. Took Benadryl 1 hour after reaction and improved.
30 2021-01-06 night sweats Fever of 102.4 F, chills, decreased appetite, night sweats.
30 2021-01-06 night sweats Fever of 101.7F while taking 500mg of acetaminophen every 6 hours. Chills, night sweats, headache, f... Read more
Fever of 101.7F while taking 500mg of acetaminophen every 6 hours. Chills, night sweats, headache, fatigue, backache/myalgias.
30 2021-01-06 pain in extremity fever, soreness in arms and legs, headache, fatigue, began last night around midnight (january 7)
30 2021-01-07 weakness Low grade fever; Sore mouth; Sore throat; still so weak; This is a spontaneous report from a contact... Read more
Low grade fever; Sore mouth; Sore throat; still so weak; This is a spontaneous report from a contactable nurse (patient). This 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EK5730), via an unspecified routed of administration, on 31Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 30-years-old. Medical history was none. Concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient just wanted to know how long a low grade fever is in the patients, it's been like three days now she still has low grade fever, mouth sore, sore throat and she is still so weak. The patient was treated with Tylenol. Outcome was not recovered. The reporting nurse considered the events related to the vaccine because the events started after that.
30 2021-01-07 feeling hot Patient felt very warm. Blood pressure was checked. BP @ 1055 was 240/130. Oxygen saturation 99%, ... Read more
Patient felt very warm. Blood pressure was checked. BP @ 1055 was 240/130. Oxygen saturation 99%, heart rate 65. BP rechecked at 11:00 and was 236/138 on Left. At 11:02 blood pressure was 232/124 on right arm, oxygen saturation 100%, heart rate 64. Stat team called. At 11:06 blood pressure was 210/120, oxygen saturation 99% and heart rate 61. Patient transferred to ED @ 11:15.
30 2021-01-08 feeling hot Dizziness c/o feeling warm and dizzy w/ diaphoretic skin. Recovered after cold pack to neck and moni... Read more
Dizziness c/o feeling warm and dizzy w/ diaphoretic skin. Recovered after cold pack to neck and monitoring for 30 min. Narrative: 7 min after vaccine, c/o feeling warm and dizzy. Skin diaphoretic and pale. unlabored breathing. @1308: 98/54, 76, 96% O2 sat.; @1316: 122/66, 92, 20, 95% O2sat and stated feeling better. Observed for 30 minutes and d/c'd in stable condition. ambulated around the room and denied any c/o prior to D/C. Resolved.
30 2021-01-08 migraine Severe chills late that night of the second vaccination. Migrane as well as light sensitivity. Preas... Read more
Severe chills late that night of the second vaccination. Migrane as well as light sensitivity. Preassure in the head as well as vertigo. Chills have almost resolved this morning into the next day after vaccination. The migranes, head preassure and vertigo still persist.
30 2021-01-08 nerve pain, weakness Friday 1/8/21 I got a bit of what i think was nerve pain or just shooting pain on the wrist of the r... Read more
Friday 1/8/21 I got a bit of what i think was nerve pain or just shooting pain on the wrist of the right-arm that was not the injection arm. Then today (Sat 1/9/21) that nerve pain is gone, but I developed a worse pain (pain of 6-7 out of 10) and additionally some weakness in the left-forearm closer to my elbow than my wrist, possibly where a tendon is (the injection arm). The pain shoots down from the elbow area towards my wrist on the posterior side. I haven?t done any extraneous work or lifted anything heavy since 1-2 days before the vaccine. It?s also my non-dominant arm so I don?t use it as much as my other arm. So far I have iced it twice and taken Tylenol which has helped the pain. The arm is currently in a sling and I haven?t tried to use it since icing it the first time.
30 2021-01-09 weakness, muscle spasms Headache beginning 18:30 PM on 01/08 Following began at 03:30 on 01/09: Headache Body aches Severe m... Read more
Headache beginning 18:30 PM on 01/08 Following began at 03:30 on 01/09: Headache Body aches Severe muscle cramps Weakness Fatigue Chest tightness Inability to concentrate Difficulty sleeping Blurred vision Treatments: Ibuprofen 400 mg at 18:30 01/08 - headache responded Ibuprofen 800 mg at 07:00 01/09 - chest tightness had resolved spontaneously. Headache, body aches, cramps, visual disturbance, concentration, and chest tightness improved over next 4 hours Ibuprofen 400 mg at 11:30 01/09 - continued improvement of symptoms Naproxen 220 mg and ibuprofen 200 mg at 20:00 01/09 - continued improvement of headache and body ache symptoms with no return of overnight adverse events
30 2021-01-09 numbness, tingling COVID-19 Vaccine (Pfizer) EL3302 Exp 05/21. Tingling in left arm and hand(same arm as side of injec... Read more
COVID-19 Vaccine (Pfizer) EL3302 Exp 05/21. Tingling in left arm and hand(same arm as side of injection) following adminstration of Dose#2. Patient also reports that he experienced numbness immediately after the first dose which went away after about 1 hour, followed by fatigue. All symptoms resolved by next morning following the first dose. BP 134/82 HR=71 @1:45pm. Patient clinically stable. Symptoms of tingling resolving. Patient was released from clinic at 1:50pm.
30 2021-01-10 weakness Generalized weakness, low grade fever, headache
30 2021-01-10 cold sweat cold sweats, shivering, mild nausea for a few hours. then fever and headache for another several hou... Read more
cold sweats, shivering, mild nausea for a few hours. then fever and headache for another several hours. all occurring overnight from 11:30 or so to resolving by noon following day with just a headache and general fatigue remaining
30 2021-01-10 muscle spasms Severe fatigue, malaise, and muscle cramping. Lasted 48 hours, started to resolve after the initial ... Read more
Severe fatigue, malaise, and muscle cramping. Lasted 48 hours, started to resolve after the initial 24hr.
30 2021-01-10 pain in extremity Soreness, hot around the area of the injection. Muscle pains
30 2021-01-10 pain in extremity Dose 1 on 12/15- Sore arm for three days after vaccination. Swelling also was present on the deltoid... Read more
Dose 1 on 12/15- Sore arm for three days after vaccination. Swelling also was present on the deltoid. Upon resolution a large bruise showed up. Dose 2 on 01/05- Sore arm near vaccination site at 12 hours. At 15 hours out woke up in middle of the night with diffuse body aches and chills. These progressively worsened. Fatigue also present in the morning with very mild fever. Developed nausea the next day as well. At 36 hours out body aches were improving but a headache developed at ~ 30 hours out. Next morning 2 days out the only thing thing that persisted was fatigue. This was gone another 12 hours later. No persistent symptoms.
30 2021-01-11 flushing The evening of 1/10 I spontaneously developed diffuse urticaria of my trunk and face, associated wit... Read more
The evening of 1/10 I spontaneously developed diffuse urticaria of my trunk and face, associated with itching, mild abdominal discomfort, and facial flushing. Symptoms somewhat improved with cetirizine. The evening of 1/11 developed recurrent spontaneous diffuse urticaria, mostly in the face. Having persistent intermittent sweats and significant fatigue. Per Patient, He have had urticaria rarely in the past, associated with shellfish. I have never had anaphylaxis before.
30 2021-01-11 tingling 01/08/2021 (2330): Chills and body aches came on suddenly and quickly. Tried to warm self and sleep.... Read more
01/08/2021 (2330): Chills and body aches came on suddenly and quickly. Tried to warm self and sleep. During the night continued to wake with body aches, chills, fever, dizziness, headache and fatigue. 01/09/2021 (0520): Spoke to Doctor and informed of symptoms. Told to take tylenol and drink lots of fluids. Medication did seem to help with body aches. Had already been drinking lots of fluids. 01/09/2021 (0730): Feeling better. Still having Fatigue and headaches. 01/09/2021 (0900): Headaches, skin tingling, flashes of chills/fever, slight body aches. Noticed a dullness to sense of taste and smell. Continued for the rest of the day. Took tylenol again. 01/10/2021 (1130): Fatigue and slight bodyaches. 01/11/2021 (1300): Slight body aches. Was tested for COVID per Rapid test per work. Negative. 01/12/2021 (0600): Only symptom remaining is very infrequent body aches when exerting myself.
30 2021-01-13 weakness, flushing received vaccine 01/08/21, reported around 02:00PM 01/09/21, onset of chills, muscle aches, fever, d... Read more
received vaccine 01/08/21, reported around 02:00PM 01/09/21, onset of chills, muscle aches, fever, did not take temps, flushed feeling, headache, injection site pain, general weakness, fatigue, unable to get up due to weakness. Around 01/09/21 at midnight reported started feeling better. 01/12/21 reports repeat of symptoms like on 01/09/21, however not as bad and did throw up, reported body sweats on this day and only lasted about 4 hours.
30 2021-01-14 weakness fever, headache, fatigue, weakness
30 2021-01-14 feeling cold In the evening after getting the shot, I started getting chills and became more sensitive to cold te... Read more
In the evening after getting the shot, I started getting chills and became more sensitive to cold temperatures. Many of joints became stiff, some of which made a cracking sound when I flexed them. Several muscles in my arms, legs and back felt sore and weak. After a restless night of sleep, the cold sensitivity is all but gone. Some of my joints and muscles are still a little stiff and sore, but I'm sure they'll be better by the next morning.
30 2021-01-14 pain in extremity nausea; vomiting 3 times; chills/rigors; sore arm; This is a spontaneous report from a contactable p... Read more
nausea; vomiting 3 times; chills/rigors; sore arm; This is a spontaneous report from a contactable physician (patient). A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0142, via an unspecified route of administration on left arm from 08Jan2021 09:30 to 08Jan2021 09:30 as single dose for COVID-19 immunisation. Historical vaccine includes first dose of BNT162B2, lot number: EJ1685, on 18Dec2020 at 09:00 AM on left arm. There were no medical history and no concomitant medications. On 08Jan2021 21:30 (12 hours after vaccine), the patient experienced sore arm; on 09Jan2021 at 00:30 (15 hours after vaccine), the patient experienced chills/rigors; on 09Jan2021 at 01:30 (16 hours after vaccine), the patient experienced nausea and vomiting 3 times. The outcome of the events was recovering. No treatment was given to the patient. No follow up attempts are possible. No further information is expected.
30 2021-01-15 facial pain About any hour after sore throat left side , headache ,stomachache ,chills, throughout next day swel... Read more
About any hour after sore throat left side , headache ,stomachache ,chills, throughout next day swelling in throat neck and face left side very hard and painful to swallow ,eat , drink felt like a golf ball was in my throat. By 3rd barely ate only had soup and a mild case of diarrhea , day face neck throat pain still and swelling , warm wash clothe hot fluids help with pain, 4 day cold things help reduces swelling in face and throat, neck still swollen and a lot more pain in face jaw , neck, still hard and painful to swallow. Current day a lot of pain in jaw neck throat face still only happening on left side of body more pain then before but less swelling neck still swollen a little bit. I tried cough drops soup heat ice and still having pain don?t want to pay for an ER visit found old painkillers haven?t taken yet. How long do symptoms like these last for ? I take medication for ADD and that masks pain to make it bearable. What do you recommend to do if I don?t want to go to the ER ?
30 2021-01-16 pain in extremity Very minor sore arm the night of vaccination. Around 1200 on 1/9/2021, I developed a minor headache,... Read more
Very minor sore arm the night of vaccination. Around 1200 on 1/9/2021, I developed a minor headache, fatigue, chills, and fever to 101.6 at noon. This resolved by 1800 after I took Ibuprofen at 1700.
30 2021-01-16 tingling, numbness, weakness Parasthesia on both sides, upper and lower extremities. Weakness, and fatigue, now right side slight... Read more
Parasthesia on both sides, upper and lower extremities. Weakness, and fatigue, now right side slight face numbness.
30 2021-01-18 numbness, tingling 2021/01/16 10:00 AM - Numbness in face (lips, jaw, gums) similar to the feeling from localized anest... Read more
2021/01/16 10:00 AM - Numbness in face (lips, jaw, gums) similar to the feeling from localized anesthesia. Also numbness and tingling in left hand. Vision is blurred and spotted vision loss. 2021/01/16 10:45 AM - Numbness in face and hands diminishing. Head ache on right temple. Vision issues persist. 2021/01/16 11:15 - Muscle pain on right abdomen and numbness beginning in feet. Vision issues cease. Headache persists. 2021/01/16 2:15 - All symptoms cease
30 2021-01-20 flushing diffuse urticaria on my trunk and face/had recurrent diffuse urticaria, predominantly in the face; A... Read more
diffuse urticaria on my trunk and face/had recurrent diffuse urticaria, predominantly in the face; Associated with itching; mild abdominal discomfort; facial flushing; Persistent intermittent sweats, and significant fatigue; Persistent intermittent sweats, and significant fatigue; first dose given on 21Dec2020 and second dose on 07Jan2021 (Day 18); This is a spontaneous report from a contactable physician (reported for himself). A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 17:00 at a single dose on left arm for COVID-19 immunization. Medical history included allergies to shellfish. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications were not reported. The patient received first dose of bnt162b2 on 21Dec2020 on left arm for COVID-19 immunization (lot number: EH9899). No any other vaccines within 4 weeks prior to the COVID vaccine. On 10Jan2021 18:00 (three days after second immunization), the patient developed diffuse urticaria on his trunk and face, associated with itching, mild abdominal discomfort, and facial flushing. Symptoms somewhat improved with cetirizine. About 24 hours later, he had recurrent diffuse urticaria, predominantly in the face, persistent intermittent sweats, and significant fatigue. Treatment was given to the patient for the adverse events. The patient underwent lab tests and procedures which included nasal swab (COVID test type post vaccination): negative on 11Jan2021. The patient has not recovered from the events.
30 2021-01-20 pain in extremity Mild arm pain, achy body. Lasted 2 days.
30 2021-01-20 pain in extremity fever of 100.7, body aches and sore arm
30 2021-01-24 flushing c/o itching in mouth and throat. Flushing noted in face. Benadryl 50 mg IM given in Right deltoid at... Read more
c/o itching in mouth and throat. Flushing noted in face. Benadryl 50 mg IM given in Right deltoid at 1002. Now 1026 with no progression and no improvement MOVE team called
30 2021-01-26 pain in extremity feel his chest and neck hurting; feel his chest and neck hurting; feeling really sick; feeling tired... Read more
feel his chest and neck hurting; feel his chest and neck hurting; feeling really sick; feeling tired; arms hurting; head hurting/ neck and all around head area, hurting real bad; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization (reported as "I guess to protect myself from other people, to protect myself"). There were no medical history and concomitant medications. The patient took his first dose on 20Dec2020, 3 weeks from there, he took the second on 10Jan2021 (reported as "it was 10th it was Sunday morning when I took it"). The patient reported that he had his second dose on Sunday morning (10Jan2021) and started feeling tired last Monday (11Jan2021). Then on 12Jan2021 (reported as "yesterday" at the time of reporting), he started to feel his chest and neck hurting. The patient stated that he woke up in the middle of the night (Sunday night) and Monday morning, he was feeling really sick so he called out rest all day on Monday (11Jan2021). Then patient woke up yesterday morning (12Jan2021) feeling good then probably about 6 o'clock last night he started feeling tired, like real bad tired and he got home. Patient lied down and woke up in middle of night, his chest, arms and head were hurting. His neck and all around head area were hurting real bad. The events were assessed as non-serious. The patient does not have the lot number but stated that it was the Pfizer vaccine. When the patient was asked if still experiencing tiredness and chest hurting, he stated "When I started, that was last night on I will go with the 12 before midnight 12 (not clear). Yes right now yeah. This is the first time my chest and my arms and my neck and like all that has been hurting, started last night". When asked for the treatment, the patient answered "I took Ibuprofen to calm it down a little bit. I took Ibuprofen if you count that as a treatment". Outcome of the events was unknown. Information about lot/batch number has been requested.
30 2021-01-28 throat numbness Pt c/o slight throat numbness and slight dizziness aprox 20 minutes after receiving second dose of ... Read more
Pt c/o slight throat numbness and slight dizziness aprox 20 minutes after receiving second dose of Pfizer Covid vaccine. Pt denied experiencing difficulty breathing, flushing of the skin, and itchiness.
30 2021-01-29 mild one side paralysis Presumed Bell's Palsy. Tearing of eye started 1/21/21, and produced R facial hemi-paresis 1/22/21.
30 2021-02-02 facial paralysis Bell's Palsy; This is a spontaneous report from a non-contactable nurse (patient's wife). A 4-decade... Read more
Bell's Palsy; This is a spontaneous report from a non-contactable nurse (patient's wife). A 4-decade-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. Medical history included Herpes Zoster (chicken pox and shingles), and hypogammaglobulinemia from an unknown date. The patient's concomitant medications were not reported. The reporter asked if her husband should receive his 2nd dose of vaccine after experiencing Bell's Palsy 12 hours after 1st dose. The patient had history of herpes zoster (chicken pox, shingles) on the same side of his face as the paralysis now (Bells Palsy). The patient was in a lot of pain and asked how serious Bell's Palsy is. Outcome of the event was unknown. No follow-up attempts are possible; information on the lot number cannot be obtained. 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 event Bell's palsy 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.
30 2021-02-04 weakness Waves of weakness; dizziness and lightheadedness; Feels like I am about to pass out while sitting/re... Read more
Waves of weakness; dizziness and lightheadedness; Feels like I am about to pass out while sitting/resting.; Fading vision approx 24hr post admin of second vaccine; This is a spontaneous report from a contactable other hcp, the patient. This 30-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: Unknown), first dose, via an unspecified route of administration in the left arm on 21Jan2021 at 13:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. Medical history included prehypertension from an unknown date and unknown if ongoing and attention deficit hyperactivity disorder from an unknown date and unknown if ongoing. The patient had no history of syncopal events. The patient did not have any known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and lisinopril (LISINOPRIL). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: Unknown), dose #1, via an unspecified route of administration on an unspecified date in the left arm as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jan2021 at 15:30, the patient experienced lightheadedness, dizziness and waves of weakness and fading vision approximately 24 hours post administration of the second dose of the vaccine. He stated it felt like he was about to pass out while sitting/resting. No therapeutic measures were taken as a result of the events. The clinical outcomes of the lightheadedness, dizziness, waves of weakness, fading vision and felt like he was about to pass out while sitting/resting were unknown. It was also 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.
30 2021-02-04 facial paralysis One week after the second vaccine I developed Bell's Palsy; This is a spontaneous report from a cont... Read more
One week after the second vaccine I developed Bell's Palsy; This is a spontaneous report from a contactable other health professional reported for himself. A 30-year-old male patient received second dose of bnt162b2, via an unspecified route of administration in left arm on 11Jan2021 11:00 at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included terbinafine, cetirizine hydrochloride (ZYRTEC), multivitamin. The patient previous received first dose of bnt162b2, via an unspecified route of administration in right arm on 21Dec2020 11:00 for covid-19 immunization. The patient experienced one week after the second vaccine, he developed bell's palsy on 18Jan2021 with outcome of not recovered. The event was reported as non-serious. The adverse event result in a visit to emergency room/department or urgent care. Treatment Prednisone, valacyclovir was received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported event Bell's palsy. 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 2021-02-04 mild one side paralysis, migraine New onset complex migraine headaches requiring admission to hospital for intractable pain for 1 week... Read more
New onset complex migraine headaches requiring admission to hospital for intractable pain for 1 week along with focal neurological symptoms with right sided weakness of upper and lower extremity that resolved.
30 2021-02-11 pain in extremity, weakness Within the first few hours of receiving the first vaccine does, feeling of tiredness occurred within... Read more
Within the first few hours of receiving the first vaccine does, feeling of tiredness occurred within a few hours of injection, but went away the next day. Also felt arm pain as excepted and abated after ~2.5 days. Symptoms of tiredness and lack of energy started again and were significantly noticeable on 2/10 (12 days post-injection). Seasonal weather dreary weather may be influencing this; however, I wanted to report it here since no other lifestyle or medical changes have occurred since the vaccine was administered. Otherwise, no adverse reactions have been recognized.
30 2021-02-13 feeling hot Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1100. Patient reported right arm heat s... Read more
Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1100. Patient reported right arm heat sensation, right neck tightness, right facial tightness at 1120 with sensation progressing up arm and across face. Given Benadryl 25mg PO at 11:50 and symptoms resolved after further observation.
30 2021-02-13 numbness Headaches, site pain, neck pain, numbness in arms and fingers on side if injection site. Extreme fat... Read more
Headaches, site pain, neck pain, numbness in arms and fingers on side if injection site. Extreme fatigue.
30 2021-02-13 pain in extremity Sore arm, movable but paid lifting it above my head. Fever on day after vaccination of 99.2-100.2. ... Read more
Sore arm, movable but paid lifting it above my head. Fever on day after vaccination of 99.2-100.2. Minor chills, minor fatigue.
30 2021-02-23 pain in extremity Pain in my knees, back, both arms, joints and shoulders. The next 24 hours, the pain peaked but I re... Read more
Pain in my knees, back, both arms, joints and shoulders. The next 24 hours, the pain peaked but I rested. By the next day I had no pain. No pain relievers were taken. Only rest.
30 2021-02-25 weakness Intense nausea; diarrhoea; headache; chills; body aches; intense fatigue; body weakness; This is a s... Read more
Intense nausea; diarrhoea; headache; chills; body aches; intense fatigue; body weakness; This is a spontaneous report from a non-contactable healthcare professional who reported for himself, a 30-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581), via an unspecified route of administration left arm, on 08Feb2021 at 12:15, at the age of 30 years, at a single dose for COVID-19 immunization. Medical history included COVID-19. The patient had no known allergies. The patient's concomitant medications were not reported. On 09Feb2021 at 03:00, the patient experienced intense nausea, diarrhoea, headache, chills, body aches, intense fatigue and body weakness. Lasting at moderate/severe intensity for about 10 hours, and mild/moderate intensity for 8 more hours. The patient tested positive for COVID-19 and fully recovered about a month prior to the vaccination. The patient stated that this felt very similar to the first day of having COVID-19, except more intense. The reported considered the events as non-serious. Tylenol was received as treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The events recovered on an unspecified date in Feb2021.
30 2021-02-25 facial paralysis Left side of face started to droop; This is a spontaneous report from a contactable consumer (patien... Read more
Left side of face started to droop; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received their second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported), via an unspecified route of administration on the left arm on 02Feb2021 14:25 at 0.3 mL, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported) via an unspecified route of administration on the left arm on 14Jan2021 at 0.3 mL, single for COVID-19 immunization. The patient reported that when at work on Sunday 07Feb2021, the left side of his face started to droop at 23:00. No treatment was received for the event. The patient did not recover from the event.
30 2021-02-25 feeling hot, numbness dizziness, feeling hot all over. Grabbed at chest "it feels a little tight" hand is getting numb no... Read more
dizziness, feeling hot all over. Grabbed at chest "it feels a little tight" hand is getting numb no reaction with 1st vaccine 1155 c/o headache. Took pt to adult urgent care in wheelchair. Patient was seen in urgent care and referred to ED at 12:50pm.
30 2021-02-28 weakness Fever and chills, debilitating headache, weakness and muscle aches, joint pain, nausea, and fatigue.... Read more
Fever and chills, debilitating headache, weakness and muscle aches, joint pain, nausea, and fatigue. Local swelling and pain at injection site. Also felt unusually anxious, though unsure if that was directly due to the vaccine or to the inability to sleep for a number of days because of the feverish chills. Acute symptoms lasted for 48 hours, and prohibited me from being able to work from home. I still have what feels like a lingering sinus headache (with no actual sinus symptoms) as well as some fatigue. Lingering headache is not debilitating, but it is irritating. Feels a bit like a sensation of pressure in my forehead.
30 2021-03-01 seizure COVID19 VACINE CLINIC SHCE: 3/1/2021 4:57 pm: 1st Seizure 20 sec long 30 year old male, had... Read more
COVID19 VACINE CLINIC SHCE: 3/1/2021 4:57 pm: 1st Seizure 20 sec long 30 year old male, had a seizure 10 mins after receiving 1st dosage of pfizer. History of Seizures per parents that are accompanying the patient, every 4 days. Dx of Epilepsy. 3 RN's attending 1. FIRST RN 2. SECOND RN 3. THIRD RN MA attending: 1. ATTENDING MA Note: First Vitals taken, 10 mins after 1st dosage of Pfizer given. 5:00 pm: BP:147/82 HR: 74 O2: 96% Notes: No complaints of pain 5:07 pm: BP: 125/73 HR:76 O2:96 Notes: No complaints of pain Outcome: 30 mins in Observation area, 2nd Dosage for Pfizer appointment made for Hospital. 5:17 pm: 2nd Seizure 10 sec long 5:19pm: EMS called by NP 5:19pm: BP:140/71 P: 69 O2: 96 5:24 pm: EMS Arrived 5:31 pm: Vitals BP:115/72 P:87 O2: 97 Outcome: Family refused EMS. EMS released the patient to the parents due to history of epilepsy at 5:33pm, patient stable. **Instructions were given to the parents by Charge RN and atttending RN, advised the family to take the patient to the ER if symptoms worsen. Family understood and agreed. 5:34 pm patient was able to walk out with parent to the exit. Director, & RN on site notified
30 2021-03-02 weakness On Saturday morning I woke up with a large rash on my left shoulder and my upper left chest. It itch... Read more
On Saturday morning I woke up with a large rash on my left shoulder and my upper left chest. It itches.; On Saturday morning I woke up with a large rash on my left shoulder and my upper left chest. It itches.; First dose on 11Jan2021 and second dose on 28Jan2021; First dose on 11Jan2021 and second dose on 28Jan2021; ached all over my body; I felt very weak; I had a temperature of 100.7.; This is a spontaneous report from a contactable consumer. A 30-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on his left arm, via an unspecified route of administration on 28Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included allergies to sulfa medicine. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 07:00AM for COVID-19 immunization (first dose). It was reported that approximately 12 hours after the 2nd shot, the patient felt very weak and ached all over her body. She had a temperature of 100.7. This lasted from late Thursday night until late Friday Morning. On Saturday morning, she woke up with a large rash on her left shoulder and her upper left chest. No treatment was received for the events. The outcome of all event fever was recovered on an unspecified date while recovering for the remaining events.
30 2021-03-02 burning sensation Patient began feeling dizzy and a burning sensation in his throat directly after vaccination. Vital... Read more
Patient began feeling dizzy and a burning sensation in his throat directly after vaccination. Vital signs were stable.
30 2021-03-02 cold sweat Fainting episode; Loss of hearing; Left collar-bone lymph node enlarged noticeable swelling to area ... Read more
Fainting episode; Loss of hearing; Left collar-bone lymph node enlarged noticeable swelling to area and left lower neck near carotid artery/lymph nodes; Soreness in area; Cold sweats; Light-headedness; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male 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 08Feb2021 at 07:00 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. 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's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no symptoms until 5 days post vaccination. On 13Feb2021 at 12:15, the patient experienced fainting episode, loss of hearing, left collar-bone lymph node enlarged (noticeable swelling to area and left lower neck near carotid artery/lymph nodes), soreness in area, cold sweats, and light-headedness. The events required a visit to the physician's office and emergency room (as reported). The clinical outcomes of the fainting episode, loss of hearing, left collar-bone lymph node enlarged, soreness in area, cold sweats, and light-headedness were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
30 2021-03-02 facial paralysis, bell's palsy BELL'S PALSY, FACIAL PARALYSIS
30 2021-03-04 flushing, feeling hot Patient received dose of vaccine on right deltoid at 4:09PM at around 4:23PM developed symptoms. Sym... Read more
Patient received dose of vaccine on right deltoid at 4:09PM at around 4:23PM developed symptoms. Symptoms described as: feeling "warmth, like if feels when you take NAICIN-flushing sensation but only minor". Other symptoms includes light rash in both arms, redness on face and arms. Excluding back, trunk and legs. Patient denies sore throat, swelling or tingling of tongue or mouth, lips. Denies drooling, no difficulty swallowing. Denies chest pain, SOB, palpitations, dizziness or light headed. No near syncope episodes. Patient refused Benadryl due to driving alone and also refused EMS to transport to ER.
30 2021-03-05 weakness Patient received his 1 dose of Pfizer vaccine and was waiting in our lobby for the recommended 15 mi... Read more
Patient received his 1 dose of Pfizer vaccine and was waiting in our lobby for the recommended 15 minutes. He fainted after about 10 minutes. He fell from the bench to the floor where he landed on his stomach. When I ran over to him, his eyes were open but his body was limp. I tapped his back and asked if he was ok, and he was startled as if I woke him up from sleep. He was alert and was able to speak, he asked for water and I gave it to him. I asked of he wanted me to call emergency services but he declined. He then vomited in the waiting room trash can. His sister was with him and began to rub his back and fan him. I asked again if he needed to go to the hospital and again her declined. I told them to please wait in the lobby at least another 15 minutes before leaving and he did. I called to patient around 8pm to check on him and he said he was fine and had no more symptoms.
30 2021-03-05 weakness Nausea, rash behind left ear, muscle pain, weakness, joint pain, lethargy, headache
30 2021-03-10 feeling hot Anxious, Sweaty, Increased HR, Hot, Tight Neck
30 2021-03-11 feeling cold Approx 5 min post vaccine, c/o dizziness/light headed- became cold with clumsy arms/hands. Placed o... Read more
Approx 5 min post vaccine, c/o dizziness/light headed- became cold with clumsy arms/hands. Placed on floor with legs elevated (given water and sugar snack)VSS: HR 48, BP 98/60. After laying supine with legs elevated: HR 78, BP 112/72, Osat 97%. At D?C HR 71, BP 118/64, OSat 98%. Escorted home.
30 2021-03-15 seizure Seizure about 1 minute after injection, seizure lasted about 1 minute
30 2021-03-17 weakness, pain in extremity, cold extremities 11pm on day of (Sunday) vaccination felt soreness in left arm at injection site and in entire upper ... Read more
11pm on day of (Sunday) vaccination felt soreness in left arm at injection site and in entire upper arm when trying to hold it up. Soreness subsided by noon the next day, Monday. No symptoms on Tuesday until late evening when tongue began to feel sore. On Wednesday morning around 6am, woke up with severe body fever, chills, muscle and joint aches, nausea, headache. Hands and fingers very cold to the touch. Severe fatigue and weakness all day. Sore tongue persisted. No respiratory symptoms present. By Thursday (today), body is still feverish, joint and muscle aches persist, light headache at times. Still fatigued and weak. All symptoms today Thursday are much weaker except for the muscle and joint pain which remains high. The reason I am reporting this is that from what I've read and been told, the delayed onset of these symptoms (almost 3 days) is very unusual, especially because I had little/no symptoms in the first 2 days of the vaccine.
30 2021-03-17 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient was very nervous about getting covid vaccination. Shortly after patient recieved covid vaccine, he sat in the chair of waiting area. He got up from chair after a few mins to try to notify someone he was not feeling well and subsequently started to fall to the ground. Rx technician caught his fall and brought him safely to the ground where he laid. he was unconscious for a 15 seconds and regained consciousness. 911 was called and paramedics subsequently came, bp was ok after
30 2021-03-18 flushing Flushing, headache, lightheadedness, hypotension, nausea this morning and had oatmeal. NKDA ... Read more
Flushing, headache, lightheadedness, hypotension, nausea this morning and had oatmeal. NKDA Vitals: 87/56 P 46 RR 18 O2: 100% - Patient: reports he is a runner, unknown baseline BP/HR Exam: General: Alert, diaphoretic, pale HEENT: Normocephalic, Neck: ROM normal
30 2021-03-19 flushing pt had flushing and redness of cheeks and neck. 25mg of benadryl issued to patient.
30 2021-03-24 seizure Pt was in waiting area when he started to have a seizure. He went rigid and flipped his chair hittin... Read more
Pt was in waiting area when he started to have a seizure. He went rigid and flipped his chair hitting his head on the cement floor. He was taken to the EMS area.
30 2021-03-25 flushing, cold sweat Patient checked in to the observation room. A patient sitting adjacent reported he 'dropped his phon... Read more
Patient checked in to the observation room. A patient sitting adjacent reported he 'dropped his phone and was out' momentarily. The patient did not fall and MD was alerted. Patient was red, flushed, clammy but alert. BP 73/42mmHg, HR 85, O2sat 97%, and RR 12. He was placed on a stretcher. He had no difficulty breathing or cutaneous symptoms. BP recovered to 120/75mmHg, HR 80, O2sat 96% and RR 12 within 15 minutes. Pt felt well and was able to be discharged home.
30 2021-03-25 grand mal seizure Pfizer-BioNTech COVID-19 Vaccine EUA About a day and a half after receiving the 1st dose of the COVI... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA About a day and a half after receiving the 1st dose of the COVID vaccine I had a grand mal seizure. I was sitting on the couch with my family and my sister said I had only fallen asleep for about 20 minutes. I take seizure prevention medication each night prior to bed. I had not taken the medication yet but I was up to date on taking this medication. I had not had a seizure in 6 years since starting my medication. I did not have a fever before or after this seizure. I was generally feeling normal prior to the seizure ,after receiving the vaccine.
30 2021-03-26 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
30 2021-03-27 pain in extremity Moderate pain w/ movement in right arm, specifically shoulder joint. First noticed on 3/14/21. Still... Read more
Moderate pain w/ movement in right arm, specifically shoulder joint. First noticed on 3/14/21. Still having symptoms 3/28/21. Plan is to follow-up with PCP if symptoms don't subside in a few weeks.
30 2021-03-28 pain in extremity Arm soreness Nausea Anxious feelings Ear ringing Syncope
30 2021-03-29 numbness slight numbness in the left side of the face; This is a spontaneous report from a contactable consum... Read more
slight numbness in the left side of the face; This is a spontaneous report from a contactable consumer or other non hcp. A 30-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot #; EL9266), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 09:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took naldecon [carbinoxamine maleate;paracetamol;phenylephrine hydrochloride] and experienced drug hypersensitivity. On 26Feb2021 11:15, the patient experienced slight numbness in the left side of the face. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.
30 2021-03-30 muscle spasms, tingling, numbness and pain in extremities Possibly a demyelinating neuropathy; I still have intermittent lumbar discomfort; started experienci... Read more
Possibly a demyelinating neuropathy; I still have intermittent lumbar discomfort; started experiencing tingling sensation (paresthesia) in both legs without loss of sensitivity or strength/mild tingling sensation in my feet and sometimes legs depending on posture; I started having lumbar pain similar to a mild muscle cramp.; back and joint pain/I started having lumbar pain similar to a mild muscle cramp.; back and joint pain; shivers; headaches; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received second dose of bnt162b2 (lot number: el1283), via an unspecified route of administration, administered in Arm Left, on 09Jan2021 11:30 as single dose for COVID-19 immunisation. Medical history included mild asthma, allergies to fur, mites and olive tree pollen from an unknown date and unknown if ongoing. Concomitant medication(s) in two weeks included finasteride taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (Lot number: ek5730) at 30-year-old on 19Dec2020 08:00 PM at left arm for COVID-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. A few hours after the second dose, the patient experienced back and joint pain, shivers and headaches for two days. On 19Jan2021 (reported as 10 days after the second dose), the patient started experiencing tingling sensation (paresthesia) in both legs without loss of sensitivity or strength. Also, the patient started having lumbar pain similar to a mild muscle cramp. The paresthesia was somewhat strong for a week and started to very slowly fade away, but the patient still has intermittent lumbar discomfort and mild tingling sensation in his feet and sometimes legs depending on posture. Possibly a demyelinating neuropathy. No treatment AE. The outcome of the events was recovering.
30 2021-03-30 tingling at immediate time of vaccine felt a tingling down left arm where he got the vaccine. then it stoppe... Read more
at immediate time of vaccine felt a tingling down left arm where he got the vaccine. then it stopped--has not had any further tingling on arm. since then, he states has felt tingling on the left ankle 2-3x per hour. As of 3-30-21 states the tingling has moved to his Left calf. same frequency of sensation. also generally states he feels a bit weird. these symptoms started since the vaccine and have not hindered his normal activities.
30 2021-03-31 weakness 2nd day after vaccine; shoulder in severe pain on same arm as injection; pain caused nausea, dizzine... Read more
2nd day after vaccine; shoulder in severe pain on same arm as injection; pain caused nausea, dizziness, and buckling over; woke up with pain that never went away; concentrated around past surgery site
30 2021-03-31 tremor Patient received vaccine. Within 2 minutes patient became sweaty with shallow breathing. Patient t... Read more
Patient received vaccine. Within 2 minutes patient became sweaty with shallow breathing. Patient then lost consciousness and began shaking. Time lasted a few minutes. Provider was notified and by the time provider arrived patient was alert and conscious. Patient was taken to an urgent care exam room for further treatment.
30 2021-04-01 night sweats, tremor The day after my second dose, I woke up around 0600 and noticed I had an extreme case of chills, nig... Read more
The day after my second dose, I woke up around 0600 and noticed I had an extreme case of chills, night sweats, and body aches. My temperature read 101. I drank water and rested on my couch, see my condition seemed we worsen as the day progressed; at one point my fever was in excess of 103 degrees. The shakes, sweating, and aches only got worse, and it wasn't until Monday morning that I felt as if I recovered.
30 2021-04-01 pain in extremity Arm soreness, fatigue, nasal congestion. Slight at first, then worsening throughout the day followin... Read more
Arm soreness, fatigue, nasal congestion. Slight at first, then worsening throughout the day following vaccination. Treated by nyquil and bestest for a day.
30 2021-04-01 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional D... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Prior to vaccine administration patient reported history of passing out from any needle and injection related procedures such as blood work and injected medication. Approximately 30 seconds after administering vaccine patient said \"oh my god\" and passed out shortly after with head rolled back. Patient regained consciousness approximately 2-5 minutes later. Felt nauseous and wanted to vomit for about 10 minutes. 911 was called. Patient refused further care and recovered after 15-20 minutes.
30 2021-04-02 weakness, tremor, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient felt light headed, appeared flushed and sweating. Had shaky hands. Patient was given orange juice and is fine
30 2021-04-02 tingling Patient felt slightly dizzy, "like rain drops hitting head," mild tingling . No medications given... Read more
Patient felt slightly dizzy, "like rain drops hitting head," mild tingling . No medications given, symptoms resolved.
30 2021-04-03 migraine Constant Migraines, vertigo, ringing of ears
30 2021-04-04 numbness No events within the first 15 minutes. After 20 minutes, car air conditioner caused a mild tingling ... Read more
No events within the first 15 minutes. After 20 minutes, car air conditioner caused a mild tingling on the left corner of my lips. Touching a hand to my left face revealed mild parathesias from my cheekbone to my mandible. No change in motor function, just sensation. Opening my mouth fully highlights the "numb" feeling even at the corner of my mouth. No treatment. Continued monitoring. I recovered from COVID-19 in late January / early February with no treatment.
30 2021-04-05 cold sweat Onset of dizziness & clamminess shortly after the shot. No nausea. No near syncope. He has had cla... Read more
Onset of dizziness & clamminess shortly after the shot. No nausea. No near syncope. He has had classic vasovagal events in the past including syncope atleast once. He thought symptoms were similar but less intense than prior V-V events. No CP, SOB, tingling. Initial BP - 132/90 P 97 O2 sat - 98% All VS remained stable throughout observation time. He felt better soon after lying down for a short time. No orthostasis occurred and he ambulated comfortably before D/C.
30 2021-04-05 seizure I suffered an apparent seizure according to the multiple pharmacists working that day. It happened w... Read more
I suffered an apparent seizure according to the multiple pharmacists working that day. It happened within less than a minute of the injection. I went to sit down to be monitored and the next thing I know is I have a pharmacist in my face asking me if I am ok and telling me an ambulance was on the way. No idea what caused it or how severe the seizure was.
30 2021-04-05 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Given fluid and food. BP and Pulse ox mo... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Given fluid and food. BP and Pulse ox monitored
30 2021-04-06 bell's palsy Left ear pain started 2 weeks after shot. 3-4 days later started to develop Bell's Palsy.
30 2021-04-06 numbness Chest tightness, numbness of left arm
30 2021-04-06 pain in extremity This is a spontaneous report from a contactable physician. A 30-years-old male patient received bnt... Read more
This is a spontaneous report from a contactable physician. A 30-years-old male patient received bnt162b2 (Formulation: Solution for injection Lot Number: EL3247), dose 1 via intramuscular, administered in Arm Left on 04Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications. The patient experienced right foot pain on 04 Mar 2021. Patient developed right foot pain 4 hours after vaccination and lasting 18 hours. Resolved spontaneously without treatment. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was recovered.
30 2021-04-06 tingling Patient arrives to observation at 14:15 following feeling lightheaded, having tunnel vision, feeling... Read more
Patient arrives to observation at 14:15 following feeling lightheaded, having tunnel vision, feeling tingly, and sweaty after receiving the vaccination. BP 111/64 HR 61 oxygen sat 99% on room air. She was given some graham crackers and water. 14:25 BP 127/73 HR 75 Pulse oxygen 97% on room air. patient stated he feels better and was escorted to the exit in a wheelchair
30 2021-04-07 unresponsive to stimuli, tremor, tingling Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-M... Read more
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
30 2021-04-08 cold sweat pt was faint, light headed and clammy; we got him to the floor, raised feet and gave ice pack, he la... Read more
pt was faint, light headed and clammy; we got him to the floor, raised feet and gave ice pack, he laid there for about 5 minutes until he felt better, we then monitored him for another 15 minutes
30 2021-04-08 migraine After first vaccine - I had a mild headache and than a migraine the next day. Felt normal after (03/... Read more
After first vaccine - I had a mild headache and than a migraine the next day. Felt normal after (03/17/21) After the second vaccine - I had a mild headache and migraine the next day (04/07/21) I still have a mild headache today. After receiving the second dose, later that day I began to get a numb tongue on the left side which is still present. Along with tiredness.
30 2021-04-08 seizure Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: THE PATIENT ... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: THE PATIENT FELL FROM A CHAIR IN THE POST-VACCINATION AREA AND WAS FACE-DOWN, NOT RESPONSIVE. THE PATIENT WAS TURNED ON HIS BACK WHEN HE BEGAN TO SEIZE, SO HE WAS PLACED ON HIS SIDE. HE RECOVERED AND OPENED HIS EYES SHORTLY THEREAFTER. HIS BP WAS 120/59 MMHG, AND HE WAS PROVIDED CRACKERS AND WATER. THIS PATIENT DENIED ANY EPISODES LIKE THIS IN THE PAST BUT ALSO DENIED HAVING BREAKFAST THIS MORNING. THE PHARMACIST RECOMMEND FOLLOWING UP WITH HIS PCP, AND A RELATIVE PICKED HIM UP FROM THE CLINIC.
30 2021-04-09 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild
30 2021-04-10 muscle spasms, burning sensation (First COVID shot) Immediately (likely due to low glucose levels): Dizziness; muscle spasms; burning... Read more
(First COVID shot) Immediately (likely due to low glucose levels): Dizziness; muscle spasms; burning in neck and face; chills/chattering teeth (settled down after about an hour, drinking Gatorade and eating). About an hour after the shot: Nausea, lightheadedness, diarrhea. Afternoon of 4/9 to 4/11: Nausea, repeated vomiting, repeated diarrhea, chills, chattering teeth, headache, body aches, fatigue, unable to keep food down, fever. Morning of 4/11: Still feeling body aches, headache, and slight nausea; fever reduced; vomiting stopped.
30 2021-04-11 feeling hot Patient reports feeling "hot and fatigued" roughly 30 minutes post-vaccination. He states he is feel... Read more
Patient reports feeling "hot and fatigued" roughly 30 minutes post-vaccination. He states he is feeling mild dizziness but denies and other symptoms. Patient was given juice and observed sitting in wheelchair. Patient reports symptom improvement and walked out on his own
30 2021-04-12 involuntary muscle movements Syncope post vaccine. Dizziness, nausea, jerking motions upon event last few seconds, incontinence, ... Read more
Syncope post vaccine. Dizziness, nausea, jerking motions upon event last few seconds, incontinence, Vomited. Pt left with girlfriend at 2:45. symptoms resolved
30 2021-04-12 pain in extremity Sporadic shooting pains, mostly in the arms
30 2021-04-13 migraine Regular Migraine Headache B/P 150/110, HR 60, O2Sat 95% Pt. left at 9:10am stat that he was feeling ... Read more
Regular Migraine Headache B/P 150/110, HR 60, O2Sat 95% Pt. left at 9:10am stat that he was feeling better, refused second B/P saying that , "It's okay."
30 2021-04-13 tremor called to see pt in vaccinator's room; pt sitting on exam table, increased RR, skin color white; pt ... Read more
called to see pt in vaccinator's room; pt sitting on exam table, increased RR, skin color white; pt diaphoretic, warm, responding to some questions; HOB placed flat and legs elevated; sweatshirt removed; mother at bedside telling pt that he is "all right"and states he has anxiety; VS at 1058:141/78; HR 64, regular; RR 22; SaO2 100%. At 1104 pt with slight tremors, continues to respond to questions; ice pak applied to neck; VS 133/84, HR 64, RR 20, SaO2 100%. 1115 pt without tremors, more awake, calm; HOB raised to 45 degrees; VS 122/72, HR 54, RR 18, SaO2 96%; Pt taking sips of Glucola and water, no c/o nausea; pt conversing appropriately. 1130 pt sitting at 90 degrees; states that he feels tired, no other c/o; VS 123/58, HR 55, RR 16, SaO2 97%. Pt ambulating in room, gait steady and strong; ambulated well in hallway. 1145-Pt left clinic stable, no c/o; mother accompanying pt and will drive pt home.
30 2021-04-14 weakness Very weak, slight headache, site of injection pain, maybe a little dizzy.
30 2021-04-14 feeling hot Pt said he felt extremely hot, sweaty, and dizzy. He then fainted, falling and hitting the side of h... Read more
Pt said he felt extremely hot, sweaty, and dizzy. He then fainted, falling and hitting the side of his face.
30 2021-04-14 numbness, tingling Major tingling and numbness in face and left side of body. Second shot has now been taken and numbn... Read more
Major tingling and numbness in face and left side of body. Second shot has now been taken and numbness has increased significantly.
30 2021-04-14 migraine Extreme migraine, pressure in the head. Blindingly painful. All other symptoms have pretty much clea... Read more
Extreme migraine, pressure in the head. Blindingly painful. All other symptoms have pretty much cleared up but this migraine and pressure in the head is none stop. No treatment has been effective at relieving it. OTC medicine. Allergy medicine. Steam bath. Netti pot. Nothing.
30 2021-04-14 tingling, numbness Sever facial numbness and tingling
30 2021-04-15 flushing Patient had vasovagal response to vaccine, no loss of consciousness, but did have flushing/sweating.... Read more
Patient had vasovagal response to vaccine, no loss of consciousness, but did have flushing/sweating. BP 109/67, HR68, RR15. Patient discharged in stable condition.
30 2021-04-15 numbness Pt complained of numbness at injection site in L arm, radiating down to forearm. BP 151/90, HR89, RR... Read more
Pt complained of numbness at injection site in L arm, radiating down to forearm. BP 151/90, HR89, RR18. No other symptoms or visual changes, self-resolved. Pt discharged in stable condition
30 2021-04-16 pain in extremity Body aches. sharp pain in finger joints. Sharp pain in joints. Pain in bones. Fatigue. Pain at injec... Read more
Body aches. sharp pain in finger joints. Sharp pain in joints. Pain in bones. Fatigue. Pain at injection site. Swollen painful lymph nodes in the armpit of the same arm of the injection site. Headache after 24 hours. Neckache. Shoulder pain.
30 2021-04-16 tingling Patient here for 2nd dose of pfizer and informed staff of a reaction he had to his first dose which ... Read more
Patient here for 2nd dose of pfizer and informed staff of a reaction he had to his first dose which included tingling throughout the body and lasted for 2 days ("comes and goes") then resolved. Pt did not notify staff of tingling at the time of the 1st dose. Patient also reported today that he had again experienced the tingling with the 2nd dose. Patient was monitored for another 30 minutes after the tingling had resolved and was provided education on adverse/allergic reactions and when to seek care prior to leaving the vaccination site.
30 2021-04-17 discomfort, brain damage At approximately 4:30pm, on the day I got the vaccine, I began to feel the effects of Encephalopathy... Read more
At approximately 4:30pm, on the day I got the vaccine, I began to feel the effects of Encephalopathy and Encephalitis, in which I began to feel pressure in my skull, and felt confusional thinking. It became hard to discern my thoughts. I also, began to experience a difficult time with my vision not being able to control what my vision was focusing on, as well as seeing a blue tint in my vision. I am also experiencing mild pressure and aches on the right side of my back and left side of my chest. These effects have been continuous for the last 4 days. To treat these symptoms I have been using natural remedies, and have maintained a stable condition due to that.
30 2021-04-17 migraine Severe migraine headache, worst of my life. Never had a migraine before. Couldn?t drive, sensitivity... Read more
Severe migraine headache, worst of my life. Never had a migraine before. Couldn?t drive, sensitivity to light and noise. Alleviated by migraine nasal spray prescribed by telehealth.
30 2021-04-18 discomfort Body discomfort and pain in the injection area
30 2021-04-18 feeling cold Assessment: 1. Suspect acute myopericarditis likely immune related/related to second dose of Covid ... Read more
Assessment: 1. Suspect acute myopericarditis likely immune related/related to second dose of Covid vaccine. 2. Troponin elevation likely due to acute myopericarditis. This is a 30-year-old male with no previous cardiac history. This past Thursday he got the second dose of Pfizer Covid vaccine. He had the usual muscle aches at the site of the injection. The next day he felt crappy, cold, etc. Nevertheless he went to work. This was Friday. On Saturday he felt better. He visited his grandma. On the way to home he felt a little dizzy. He took a meclizine when he got to the his grandmother's home. He helped her eat, and then went home. On Saturday night he started to feel cold and chilled. His face felt li
30 2021-04-18 pain in extremity Pain in right arm to start followed by chills and tiredness. The next day much the same. Now 3 days ... Read more
Pain in right arm to start followed by chills and tiredness. The next day much the same. Now 3 days later still feeling nausea and fever and chills.
30 2021-04-19 pain in extremity Major soreness in left arm, headache. Approximately 5-6 hours after injection At soreness, took 400m... Read more
Major soreness in left arm, headache. Approximately 5-6 hours after injection At soreness, took 400mg ibuprofen, 50mg zinc supplement and 2tbsp of elderberry supplement. Overnight, fever with chills. Around midnight. No medicines taken. Fever had broken by morning.
30 2021-04-19 tremor, flushing, unresponsive to stimuli Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: F... Read more
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: patient was rushed to the hospital by the ambulance, i followed up with the patient and he left the hospital hours after on the same day. patient is now recovered and feeling well.
30 2021-04-20 migraine about 18 hours after shot I began experiencing migraines and sensitivity to light and sounds. The mi... Read more
about 18 hours after shot I began experiencing migraines and sensitivity to light and sounds. The migraines lasted for about 10 hours. Shortly after, about 27 hours after the shot i began experiencing a fever and body aches that are still happening as i fill out this sheet.
30 2021-04-20 seizure Patient experienced syncope and possible seizure post vaccination, transported to hospital via ambul... Read more
Patient experienced syncope and possible seizure post vaccination, transported to hospital via ambulance
30 2021-04-20 seizure PATIENT ACCOMPANIED BY HIS WIFE REPORTED TO PHARMACY FOR HIS FIRST DOSE OF THE COVID-19 PFIZER VACCI... Read more
PATIENT ACCOMPANIED BY HIS WIFE REPORTED TO PHARMACY FOR HIS FIRST DOSE OF THE COVID-19 PFIZER VACCINE. THE PATIENT REPORTED THAT HE DID NOT LIKE NEEDLES AND ASKED IF HIS WIFE COULD BE WITH HIM DURING HIS VACCINATION. THE PATIENT WAS VERY ANXIOUS BUT THEN HAD CALMED DOWN. AFTER COMPLETING THE VACCINE , THE PATIENT STATED THAT HE WAS FEELING OKAY PRIOR TO PROCEEDING TO A VACCINE WAITING CHAIR JUST OUTSIDE THE PHARMACY BUT INSIGHT OF THE PHARMACY STAFF. THE WIFE AFTER ABOUT 4 MINUTES POST VACCINATION ASKED IF WE COULD LAY HIM DOWN. ONE OF OUR TECHNICIANS STATED THAT THE PATIENT WAS STARTING TO SEIZE. LAYING THE PATIENT ON THE FLOOR. CONFIRMED THAT 911 SHOULD BE CALLED. OUR TECHNICIANS, COMPLETED THE CALL AND NOTIFIED MANAGEMENT PER POLICY. BY THE TIME THE PATIENT WAS TO THE FLOOR, HIS SEIZING HAD SUBSIDED (~20-30 SECONDS TOTAL). THE PATIENT WAS ON THE FLOOR AT APPROXIMATELY 09:29 AM ON 4/21/21.STABILIZED THE PATIENTS' NECK AND HEAD WHILE HIS WIFE, A REGISTERED EMERGENCY ROOM NURSE OBTAINED A PULSE. GRABBED THE CLEAN BLOOD PRESSURE DEVICE SPECIFIC FOR VACCINE EMERGENCIES. A BLOOD PRESSURE WAS OBTAINED 120/63 WITH A HEART RATE OF 57 (NORMAL ADULT CUFF, LEFT ARM, IN THE SUPINE POSITION ). THE PATIENTS' FEET WERE ELEVATED ON A CHAIR TO RETAIN BLOOD FLOW AND COLOR. SHORTLY AFTER EMERGENCY MEDICAL SERVICES ARRIVED AND COMPLETED THEIR ASSESSMENT.
30 2021-04-21 tingling Tingling and occasional electric shooting pain in right arm, usually originating in the right wrist ... Read more
Tingling and occasional electric shooting pain in right arm, usually originating in the right wrist and extending both into the right little finger and a distance upward as far as the top of the right tricep.
30 2021-04-21 seizure like phenomena, tremor Syncope event after receiving second dose of Pfizer covid vaccine. He walked away into observation a... Read more
Syncope event after receiving second dose of Pfizer covid vaccine. He walked away into observation area after getting vaccine. Approximately 10 minutes later , patient became pale and diaphoretic. Limbs began to shake and it appeared to be having seizure-like activity. Pl lowered to the floor and legs were propped up. Heart Rate was inthe 40's, BP was unmeasurable. After several minutes HR came up to mid 80's and SA02 sats were normal. EMS notified for transport to ED.. Hx diabetes and had not eaten all morning. Last seizure was 2 years ago
30 2021-04-22 tingling Patient said they had tingling in feet, sweating. No other side effects, recovered on their own with... Read more
Patient said they had tingling in feet, sweating. No other side effects, recovered on their own within few minutes and refused EMS. Vital signs stable. No interventions needed.
30 2021-04-22 seizure Systemic: Seizure-Severe, Additional Details: Pt with history of seizure passed out while sitting do... Read more
Systemic: Seizure-Severe, Additional Details: Pt with history of seizure passed out while sitting down hit head then started seizing. Pt was placed on side till seizing stopped and until ambulance got to store. Pt was dazed and out of it while ambulance took him away.
30 2021-04-23 tremor, feeling jittery I'm really hoping to get some guidance as I seem to be having a very strange reaction to the vaccine... Read more
I'm really hoping to get some guidance as I seem to be having a very strange reaction to the vaccine. Approximately 2 weeks from my 1st vaccine on 3/16/2021; I had sudden panic attacks. I never had a panic attack or anxiety before. Following the panic attacks, I have been struggling with several major symptoms: no appetite/ loss of appetite, chronic headache(almost daily), GI problems, and most noteworthy, daily inexplicable waves of anxiety and worry. As mentioned, I have no history of anxiety or panic attacks. I also am experiencing chills, sweating, shaking, and a lot of brain fog/ inability to concentrate. The symptoms did start to subside to some degree, but as of today (4/24/21) I had more sudden and inexplicable rushes of anxiety and panic. Some other symptoms are an elevated resting heart rate and higher than usual blood pressure. I have also been waking from sleep suddenly with a feeling of jitteriness in my chest and palpitations. I have had trouble sleeping and almost feel like a rush of adrenaline hits me right before I start to fall asleep. I received my 2nd vaccine on 4/6/2021 because I didn't think these could be related to the vaccine. I'm seeing many people online mentioning similar reactions after getting their Pfizer vaccine.
30 2021-04-24 concussion Patient stated he passed out while driving and ended up crashing into a tree. He stated he was trea... Read more
Patient stated he passed out while driving and ended up crashing into a tree. He stated he was treated at a hospital where it was determined he had a concussion. He was later released and did not say he had sustained any other injuries. He informed me at the time of his second dose. He stated he wanted to get the second shot but the doctor who treated him advised him not too. I told him to delay until further consultation with same doctor or a 2nd consultation with another doctor.
30 2021-04-24 feeling cold Ran a fever that reached 100.8; fever subsided after 16 hours. Chills at the onset of the symptoms ... Read more
Ran a fever that reached 100.8; fever subsided after 16 hours. Chills at the onset of the symptoms (1-2 hours). Fatigue (has not yet subsided). Muscle pain, particularly in the left arm, though was present in the rest of the body. Subsided in the left arm after 16 hours.
30 2021-04-24 feeling hot After 2nd dose, client reported feeling hot, dizzy, and light-headed. EMT assisted client into gravi... Read more
After 2nd dose, client reported feeling hot, dizzy, and light-headed. EMT assisted client into gravity chair. Client was sweating and warm-to-touch. Client drank water from personal water bottle. RN provided education on vaccine side-effects and advised to remain in-place for observation for 30 minutes. Vital signs were within normal limits. Client reported side-effects resolved 15-minutes later. Client was advised to seek emergency medical attention if side-effects return and/or worsen. Client was provided information on VSAFE and walked out of vaccine site unassisted with steady gait after an additional 15 minutes observation.
30 2021-04-25 bell's palsy Bell?s Palsy
30 2021-04-26 weakness patient immediately felt light headed and weak as soon as the shot was being injected into his delto... Read more
patient immediately felt light headed and weak as soon as the shot was being injected into his deltoid. After 2 minutes the patient still felt weak and the staff proceeded to lay him onto the floor. At this time, the patient passed out for about 5-7 seconds and he was conscious for the rest of the time. Blood pressure was 100/49 at the time when he fainted. By the time the EMT came, his BP was 112/69.
30 2021-04-27 burning sensation Small cluster of hives appeared on back of neck just around 24 hours after first dose of vaccine. It... Read more
Small cluster of hives appeared on back of neck just around 24 hours after first dose of vaccine. It has been six days since getting the vaccine and still no signs of them disappearing. Followed the guideline of taking 50mg of diphenhydramine as suggested with minimal success in getting the hives to go down completely. They will subside slightly sometimes but not at all entirely and are currently still present. There is occasional itchiness which comes and goes as well as a slight itchy burning sensation in the right hand seemingly random at times. A small hive also developed on the right hand that does not originate from where the itch on the hand comes from.
30 2021-04-27 migraine Pfizer-BioNTech COVID-19 Vaccine EUA Started getting a migraine at 0300. Turned worse by 0530. Got ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Started getting a migraine at 0300. Turned worse by 0530. Got a fever ranging from 100.1-100.5 for the majority of the day. Fever dropped to 99.8 by 2000 that night. All day I had muscle tightness and stiffness to the point I could not function for work or move with out being in extreme pain.
30 2021-04-27 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
30 2021-04-28 flushing, tremor Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Additiona... Read more
Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Additional Details: Had a panic attack
30 2021-04-28 pain in extremity Sore arm on day of shot and second day of shot third day swollen lymph node under arm pit near chest
30 2021-04-28 pain in extremity 1st Dose (April 3rd) - Soreness in arm for first few days - Bad fever, headache, fatigue day 4 2nd ... Read more
1st Dose (April 3rd) - Soreness in arm for first few days - Bad fever, headache, fatigue day 4 2nd Dose (April 23rd) - About 12 hours after experienced bad fever (this time measured between 100.5-101.5), headache, chills causing shivering, and fatigue (though couldn't sleep with fever) first night. This continued for two days. - It is now 6 days out, and still experiencing brain fog (days 3-6 so far), which I didn't really notice until fever began reducing on day 2. The fog has also come with general fatigue, though not as bad as during fever period. Can be difficult to concentrate, focus, and feels associated with slight pressure in ears.
30 2021-04-28 seizure Seizure.
30 2021-04-28 seizure Possible seizure, ER treatment and keppra 500mg prescribed.
30 2021-04-29 tingling Patient was feeling faint and dizzy and complained of tingling. He was give benadryl 25mg and monit... Read more
Patient was feeling faint and dizzy and complained of tingling. He was give benadryl 25mg and monitored for 38 minutes. Symptoms were resolved before he left.
30 2021-04-30 pain in extremity 5 minutes, dizziness. Arm pain radiating down to the hand after 15 minutes. Pleural pain and tachyca... Read more
5 minutes, dizziness. Arm pain radiating down to the hand after 15 minutes. Pleural pain and tachycardia 1 hour after. Throat closing. Trouble breathing. Respirations 26. Pulse 130-170 resting. Normal 60-75. Took 25mg Benadryl tablet orally. 2 minutes after feeling of throat closing.
30 2021-05-01 facial paralysis 4/17 2nd doze Pfizer finished, 4/26 found myself having Bell's Palsy symptoms: lose of forehead and ... Read more
4/17 2nd doze Pfizer finished, 4/26 found myself having Bell's Palsy symptoms: lose of forehead and brow movements (left face), inability to close eyelid(left eye),drooping of the mouse treatments now: Corticosteroids +Vitamin B
30 2021-05-01 pain in extremity Chills, fever, soreness of the arm, insomnia.
30 2021-05-02 migraine I started feeling achey close to midnight, so roughly 12 hours after the shot. I had chills througho... Read more
I started feeling achey close to midnight, so roughly 12 hours after the shot. I had chills throughout the night. In the morning I had a migraine, chills, aches, and a 102 degree fever. This lasted most of the day until around 6pm. I'd taken tylenol in the morning and ibuprofen around 3pm. By 7-8 I felt much better. I started feeling chills again around midnight, but after sleeping, I feel basically 100%.
30 2021-05-03 unresponsive to stimuli Patient received second dose of Covid19 Pfizer-BioNTech. A few minutes later, my pharmacy technician... Read more
Patient received second dose of Covid19 Pfizer-BioNTech. A few minutes later, my pharmacy technician, was informed that patient had collapsed in front of the pharmacy. I was in the immunization room with another patient. I grabbed an Epinephrine 0.3mg auto injector and went to the patient. He was unconscious and unresponsive. I told him to call 911 and to send for paramedics. I administered one dose of 0.3mg epinephrine and patient woke up within a few seconds. He stayed sitting with me assisting as this was his most comfortable position. He later transferred to a chair and paramedics/emt took over when they arrived.
30 2021-05-04 seizure Within the first 5 minutes of his 15 min wait time after receiving the vaccine, he appeared to be ha... Read more
Within the first 5 minutes of his 15 min wait time after receiving the vaccine, he appeared to be having a seizure & went unconscious. EMS was called, they checked his vital signs. He declined offer to go to hospital, waited another 15 min, then drove home.
30 2021-05-06 weakness Fever up to 103 at peak and at an average of 101 for 3 day after vaccine. Diarrhea for 6 days after... Read more
Fever up to 103 at peak and at an average of 101 for 3 day after vaccine. Diarrhea for 6 days after vaccine which lead to intense abdominal pain. General weakness due to dehydration
30 2021-05-06 pain in extremity Headache, Dizziness, Shoulder Pain, Arm pain and Stomach pain started 3-4 days after the vaccine an... Read more
Headache, Dizziness, Shoulder Pain, Arm pain and Stomach pain started 3-4 days after the vaccine and dizziness has affected the daily activities including work. Been happening for 5 days now
30 2021-05-07 cold sweat, discomfort Recurring fever, chills, cold sweats, body pain / soreness, massive headache, constant discomfort, l... Read more
Recurring fever, chills, cold sweats, body pain / soreness, massive headache, constant discomfort, lethargy
30 2021-05-07 migraine Persistent headache/migraine; Persistent headache/migraine; chills; extreme fatigue; insomnia; This ... Read more
Persistent headache/migraine; Persistent headache/migraine; chills; extreme fatigue; insomnia; This is a spontaneous report from a contactable Physician (patient). A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jan2021 11:00 (Lot Number: EL3248) at single dose for COVID-19 immunisation. The patient medical history was none, no known allergies. Patient didn't have COVID prior vaccination. There were no concomitant medications in two weeks and no other vaccine in four weeks. The patient previously received the first dose of bnt162b2, lot number: EL1284, at 30 years old on 30Dec2020 11:00 AM in Left arm for COVID-19 immunization. The patient experienced persistent headache/migraine, chills, extreme fatigue, insomnia. Adverse events started from 20Jan2021, 04:00 PM. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab COVID Test: negative on 04Jan2021. The outcome of the events was recovering.
30 2021-05-08 cold sweat, numbness Cold sweats overnight, body hot to the touch in the morning but no fever (98.7). Dehydrated, body so... Read more
Cold sweats overnight, body hot to the touch in the morning but no fever (98.7). Dehydrated, body sore, head ache. Numb finger tips.
30 2021-05-08 muscle spasms, numbness and pain in extremities Stabbing pains in both kidneys every time I would inhale, stabbing pains in stomach every time I wou... Read more
Stabbing pains in both kidneys every time I would inhale, stabbing pains in stomach every time I would exhale; lasted approximately 1 hour. Intense throbbing pain in the head. Sporadic pain and ringing in both ears. Stabbing pain in left armpit. Fever dreams / delirium. Chills, fever. Sensitivity to cold. Spasms of abdominal muscles. Spasms and ?tics? of neck and shoulder muscles. Spasms of leg muscles. Nausea. Extreme weakness of upper body.
30 2021-05-09 facial pain Injection on may 6th, on my seventh around 12pm, lymph nodes near ear and below jaw became wnlarged ... Read more
Injection on may 6th, on my seventh around 12pm, lymph nodes near ear and below jaw became wnlarged and sore,, noticed red hot itchy spot on left cheek. Progressively expanded through the day, accompanied by fever, body aches. Each day has gotten progressively worse. Rash spreading to scalp following day and migrating left to right across face. May 9th went to emergency room for treatment. Prescribed zyrtec, benadryl and prednisone along with Valtrex. Unable to identify cause of rash. As of May tenth the rash has continued to grow and is now on spread to the top of my scalp, back of my skull and pain as shown up in nerve in jaw on right side
30 2021-05-09 numbness Immediate stinging and numbing feeling in index finger that lasted about a week
30 2021-05-10 involuntary muscle movements Immediately after receiving vaccine, patient eyes began to roll. He then started having jerking move... Read more
Immediately after receiving vaccine, patient eyes began to roll. He then started having jerking movements and body stiffness. Patient was lowered to floor. BP 120/90 P64, SpO2 98% on room air. Patient A&O x3 after approx. 1 min. Cool compresses applied to face/head along with fan. BP 130/99, P81, SpO2 99% room air. Patient sat upright. Denies any further complaints and states, "This always happens when I see needles and get a shot." Additional monitoring in recovery. Patient ambulated from facility with mother. No s/sx of distress noted.
30 2021-05-10 feeling hot hot , red face, dyspnea
30 2021-05-11 feeling of body temperature change felt a cold and then hot burning mostly at night; like his legs were heavy; bad bruising on the delt... Read more
felt a cold and then hot burning mostly at night; like his legs were heavy; bad bruising on the deltoid muscle and bleeding; bad bruising on the deltoid muscle and bleeding; This is a spontaneous report from a non-contactable consumer reported for his son. A male patient in his 30's received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Apr2021 (at age of 30's, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter stated that his son had the first dose of the Covid-19 vaccine on 12Apr2021 and ten days later he presented "something like burning feet, felt a cold and then hot burning mostly at night, felt like he ran a marathon and felt like his legs were heavy". Stated that the side effects resolved after 24 hours. Added that his son was in his 30s. Stated that the vaccine administrator had a poor technique and his son presented bad bruising on the deltoid muscle and bleeding. He had no preexisting condition and would like to find out if this event has been reported. Reporter would like to consult if his son should get the second dose of the Pfizer Covid-19 vaccine if he presented side effects after the first dose. The outcome of the events "Feeling hot and cold/ Heaviness in limbs" was recovered on 23Apr2021. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
30 2021-05-11 pain in extremity Sore left arm, chills, feverish feeling, vomiting starting around 5:50 PM today
30 2021-05-11 pain in extremity Other than soreness in my left arm for the first few days, I did not notice anything else (nor did I... Read more
Other than soreness in my left arm for the first few days, I did not notice anything else (nor did I look at the injection site). However, today (5 days after the 2nd injection) I noticed my left arm is yellow in color (about 1 inch tall by 2 inches wide), but there is no soreness or any other associated complications.
30 2021-05-12 numbness Systemic: Numbness (specify: facial area, extremities)-Medium
30 2021-05-12 migraine with aura heart fluttering; arrhythmias; Fever; chills; intense pressure behind eyes; headache; muscle weaknes... Read more
heart fluttering; arrhythmias; Fever; chills; intense pressure behind eyes; headache; muscle weakness; fatigue; brain fog; intense body pains/aches; intense body pains/aches - especially at joints (knees, wrists, ankles); heart pounding; insomnia; lack of appetite; migraine with aura; lethargy; This is a spontaneous report from a contactable pharmacist (patient). A 30-years-old male patient received bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/facility. The patient medical history was not reported. No known allergies. The patient's concomitant medications were none. No other vaccine in four weeks. No other medication in two weeks. The patient previous received the first dose on 31Mar2021 11:00 (Lot number=ER8737) as single dose at Left arm for covid-19 immunization. The patient had no reaction on previous exposure to vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Fever, chills, intense pressure behind eyes, headache, muscle weakness, fatigue, brain fog, intense body pains/aches - especially at joints (knees, wrists, ankles), arrhythmias/heart fluttering, heart pounding, insomnia, lack of appetite, migraine with aura, lethargy on 22Apr2021 13:00. The outcome of the events was recovering. No treatment received.; Sender's Comments: The contributory role of the suspect product bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization to reported events is possible based on temporal association and known profile of the product.
30 2021-05-13 discomfort High Fever (103 +) Chills Body Aches Nausea and Stomach Pain Joint Pain Was unable to eat or drink ... Read more
High Fever (103 +) Chills Body Aches Nausea and Stomach Pain Joint Pain Was unable to eat or drink causing dehydration. Main add to the community if you have stomach sensitivity this Vaccine caused extreme discomfort and feeling of high risk outcome with high temperature and unable to consume fluids
30 2021-05-13 tingling, tremor Blood pressure spike to 190/110, Temperature increase to 100 degrees F, Heart rate accelerated to 12... Read more
Blood pressure spike to 190/110, Temperature increase to 100 degrees F, Heart rate accelerated to 120 bpm, body shakes, tingling sensation all the way down to finger tips, within 20 minutes of vaccine administration. Sent the emergency room and monitored for 4 hours until vital returned to normal.
30 2021-05-14 bell's palsy Bell's palsy
30 2021-05-14 cold sweat, pain in extremity Low grade fever - Tuesday to Saturday Extreme headache: Tuesday Body aches, cold sweat, and minor he... Read more
Low grade fever - Tuesday to Saturday Extreme headache: Tuesday Body aches, cold sweat, and minor headache: Tuesday - Saturday Blood Clot found in my leg behind my knee Saturday (today). Symptoms of pain and swelling started Tuesday. Reached high pain point Thursday and it didn't get better so I was recommended to go to the emergency room.
30 2021-05-14 pain in extremity, burning sensation Rash with pain and burning sensation located on the arm in a straight line where vaccinated the nigh... Read more
Rash with pain and burning sensation located on the arm in a straight line where vaccinated the night of receiving the vaccine. Began to spread along the arm, but nowhere else on the body and develop blisters and redness. Along with rash was constant pain through the whole arm and pain in armpit where lymph node is located. Went to a healthcare clinic one week later who said it was a possible case of shingles. Took a sample to send to lab. Was prescribed valacyclovir.
30 2021-05-15 numbness, bell's palsy Pt came in to let us know that he had numbness on left side of face, he stated he went to ER and the... Read more
Pt came in to let us know that he had numbness on left side of face, he stated he went to ER and they diagnosed him as having Bells Palsy. This has affected his entire left side of face and his eye.
30 2021-05-16 pain in extremity, tenderness I've had symptoms of leg pain/tenderness in my left leg after each of the two doses. The first time ... Read more
I've had symptoms of leg pain/tenderness in my left leg after each of the two doses. The first time I thought it was due to not resting enough and overworking, but there was no possibility of that after the second dose on May 11th. I have been resting as much as possible and trying to alternate heat/ice therapy and seems to be helping, but am worried what I have may be blood clots. I do not have a primary physician at this time but am now looking.
30 2021-05-19 seizure like phenomena Patient experienced a minor seizure-like reaction that lasted for about 5 seconds. Patient was monit... Read more
Patient experienced a minor seizure-like reaction that lasted for about 5 seconds. Patient was monitored for about 30 minutes. Blood pressure, heart rate and oxygen saturation were normal.
30 2021-05-19 unresponsive to stimuli, weakness, flushing Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: PATIENT FELL OFF CHAIR AFTER HE GOT HIS PFIZER COVID VACCINE AND HIT HIS HEAD ON BOARD. HE DEVELOPED A BRUISE ON FOREHEAD. PATIENT LOOKED PALE. PHARMACY TECHNICIAN GAVE HIM SOME WATER AND TARGET STAFF APPLIED ICE PAK ON FOREHEAD AND OFFERED HIM SOMETHING TO EAT
30 2021-05-20 unresponsive to stimuli Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechia... Read more
Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day.
30 2021-05-21 feeling hot Within 10 mins of getting vaccine, I felt hot, lightheaded, nauseous, fast heart rate.
30 2021-05-21 unresponsive to stimuli, seizure like phenomena, muscle twitching About 5 minutes after injection, patient was sitting in chair. Wife sitting next to him noticed he s... Read more
About 5 minutes after injection, patient was sitting in chair. Wife sitting next to him noticed he started twitching. Pt appeared to have seizure like activity, was non responsive with eyes open. Pt was lowered to laying down on the ground. Within 1-2 minutes patient became responsive. Pt was not able to recall previous 4-5 minutes. Pt was given water and crackers and was able to move back to sitting position. Pt was monitored for 45 minutes without any other event. Pt was called the next morning and was left a voicemail with no answer
30 2021-05-25 feeling hot nausea; lightheadedness; ill-appearing; Hot; vomiting; dry mouth; chills; This is a spontaneous repo... Read more
nausea; lightheadedness; ill-appearing; Hot; vomiting; dry mouth; chills; This is a spontaneous report from a contactable Healthcare professional. A 30-Year-old Male patient received BNT162B2 (BNT162B2) 1 single dose via Unknown route of administration in unspecified anatomical location on 20210315 (Lot number: EN6206) for COVID-19 immunisation. On 15Mar2021, during his 15-minute waiting period after the injection, the patient experienced chills, dry mouth, Hot, ill-appearing, light-headedness, nausea and vomiting. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. The patient had complained of chills and vomiting (scantly, x 3 times) and was ill-appearing. He was not diaphoretic. Zofran. The therapeutic measures taken as a result of the adverse events were not reported and follow up response to treatment had no change. The patient was transported to ED (emergency department) by POV (privately owned vehicle). The patient had not recovered from the events at the time of this report. No follow-up attempts are possible. No further information is expected.
30 2021-05-28 unresponsive to stimuli as soon as got the shot he passed out , not responding , gave him epinephrine 0.3 mg auto injector,... Read more
as soon as got the shot he passed out , not responding , gave him epinephrine 0.3 mg auto injector, with in 5 minutes paramedics came and took care of him , he is fine, talking good, , feeling , after few minutes he walked away with family member
30 2021-05-29 cold sweat Patient received the first stick where the hub of the needle was split and the vaccine ran down his ... Read more
Patient received the first stick where the hub of the needle was split and the vaccine ran down his arm. Upon deciding that he had not received any of the vaccine, I administered a second dose bc the hub was split all the way down. I administered it and left him to go wash my hands. After about a minute, we heard a loud sound. When I got to him, he was getting up and was pale. His face was white, hands clammy and sweating. He did not remember falling. I took his bp which was 99/65. My tech went and got him some water. He started drinking and then vomited. He said he immediately felt better. his girlfriend went and got him some juice. He sat there for about 15 more minutes. He sated that he felt fine, but he had not had anything to eat or drink that morning. (also a beer the night before). He got up and walked out without any help and was going to get him something to eat. He was hungry.
30 2021-05-30 numbness, pain in extremity I received my second COVID vaccine on 5/13/2021. My arm got intensely sore and it keeps getting brui... Read more
I received my second COVID vaccine on 5/13/2021. My arm got intensely sore and it keeps getting bruised around the area randomly and it is still very sore weeks later. I can?t sleep on that side of my arm because it hurts and my arm is constantly ?falling asleep? . It hurts a lot and isn?t normal.
30 2021-06-02 weakness Had bloody stool followed by dizziness, ringing in ears, loss of strength, heavy sweats-- nearly pas... Read more
Had bloody stool followed by dizziness, ringing in ears, loss of strength, heavy sweats-- nearly passed out. Most symptoms passed after event but was weak for the rest of the day.
30 2021-06-02 pain in extremity High fever 38.8 degrees in Celsius or 101.84 degrees in Fahrenheit, right arm pain, back pain, bone ... Read more
High fever 38.8 degrees in Celsius or 101.84 degrees in Fahrenheit, right arm pain, back pain, bone pain, splitting headache, heart speeding up, diarrhea, fatigue, feeling very irritated. No treatment but drinking a lot of cold water. Body temperature back to normal and feeling much better 2 days after the shot.
30 2021-06-03 weakness, burning sensation - following the vaccine i began to develop a very severe sore throat (no cough) that last for up to ... Read more
- following the vaccine i began to develop a very severe sore throat (no cough) that last for up to 5+ days. - body fatigue and weakness ensues and sore throat persists. - constant runny nose after day 4 - burning sensation comes and goes in nostril / sinus cavity - on day 5 i begin to have severe sinus congestion all throughout my head and face
30 2021-06-03 pain in extremity bilateral lower extremity muscle "soreness/weakness"; fatigue; mild headache for most of the day (co... Read more
bilateral lower extremity muscle "soreness/weakness"; fatigue; mild headache for most of the day (coughing made it worse); bilateral lower extremity muscle "soreness/weakness"; coughing; left arm pain/bilateral arm pain (worse of the left); This is a spontaneous report from a non-contactable physician. A 30-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration administered on arm left on 04Mar2021 at single dose for covid-19 immunisation (At the age of 30-year-old). Medical history included chronic hives from an unknown date and unknown if ongoing. The patient had known allergies: shellfish from an unknown date and unknown if ongoing. Concomitant medications in two weeks included cetirizine taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. Covid prior to vaccination was unknown and the patient was not covid tested post vaccination. On 04Mar2021, the patient experienced left arm pain (the day of the vaccine)and that day after vaccine the patient had bilateral arm pain (worse of the left), bilateral lower extremity muscle "soreness/weakness", fatigue, mild headache for most of the day (coughing made it worse). No treatment was given for any of event. The outcome for all the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
30 2021-06-03 seizure, tremor Patient experience what it look like a seizure right after getting the COVID-19 vaccine. He started ... Read more
Patient experience what it look like a seizure right after getting the COVID-19 vaccine. He started shaking and lost consciousness. The patient was sitting on a chair and the immunizer technician hold the patient so he didn't fell on the floor and requested 911 to be called. The paramedics came an assisted the patient. The patient recovered consciousness and stated that he felt fine. The paramedic help him get into his car. The patient's wife was present at the time the event happened.
30 2021-06-03 tenderness, migraine Developed tenderness and sensitivity under left arm on rib cage / upper torso area approximately 2 w... Read more
Developed tenderness and sensitivity under left arm on rib cage / upper torso area approximately 2 weeks after 2nd dose. It was initially suspected to be a rash or allergic reaction, however there was no redness or visible signs of a rash in the area. Approximately 20 days after 2nd vaccine dose, severe migraine headache occurred which lasted for approximately 6 days. After about 3 days of headaches, COVID-19 test was taken and confirmed negative. This was followed by a visit to urgent care facility. Shot of Toradol was given for the headaches and an anti-inflammatory prescription was provided. Also mentioned to the nurse practitioner the sensitivity at left rib cage / upper torso area. It was confirmed by a nurse practitioner to be early signs of shingles. Prednisone and anti-viral were prescribed for the shingles outbreak. Thankfully the shingles were caught early enough to be treated immediately and I only missed 5 days of work (Mar 24- Mar 30) and the shingles did not develop into large blisters or boils.
30 2021-06-05 involuntary muscle movements After the pt received the vaccine, he asked me for some water because he wasn't feeling very well. I... Read more
After the pt received the vaccine, he asked me for some water because he wasn't feeling very well. I didn't have any on hand, so I offered chocolate. When I came back he tried to reach for it, but was struggling. He dropped it and started making jerking movements and slumping over. I put my hand on his chest to keep him propped up and called for my technician. After a minute or so, he was responsive, but sweating and his skin tone became washed out. I told him he should lay on the floor and prop his feet up on the chair. He said that made him feel better. I got him some orange juice to drink after he got off the floor. He remained near the location for 30mins and then did some shopping to make sure he would be okay before leaving with his wife.
30 2021-06-05 unresponsive to stimuli, seizure, tremor, tremor Systemic: Fainting / Unresponsive-Medium, Additional Details: pt fainted about 10min after administr... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: pt fainted about 10min after administration of vaccine. He shaked (seized) for a few seconds and then awoke. 911 was contacted
30 2021-06-09 feeling cold, numbness Numbness on side of body receiving vaccine (left arm, left side of neck, left side of face) Heart pa... Read more
Numbness on side of body receiving vaccine (left arm, left side of neck, left side of face) Heart palpitations Chest pain Flu-like symptoms (fever, headache, coldness, lethargy)
30 2021-06-09 pain in extremity, weakness This is a spontaneous report from a contactable consumer or other non health care professional. A 30... Read more
This is a spontaneous report from a contactable consumer or other non health care professional. A 30-years-old male patient received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 13:45 (Batch/Lot Number: EL3247) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took streptomycin and experienced drug hypersensitivity. The patient did not receive other vaccine in four weeks. The patient did not receive other medication in two weeks. On 10Mar2021 at 08:00 AM, the patient had experienced very sore arm the second day with pain in extremity, weakness, fatigue and mild fever. No treatment was received for the adverse events. The outcome of all events was not received. No follow-up attempts are possible; no further information is expected
30 2021-06-10 inability to speak Patient received his first dose of Pfizer COVID Vaccine (Lot #EW0185, Exp 08/2021) in left deltoid o... Read more
Patient received his first dose of Pfizer COVID Vaccine (Lot #EW0185, Exp 08/2021) in left deltoid on 05/21/2021 at 11:58 am. Patient states he had been taking penicillin for tonsillitis for approximately 3 days before receiving his first dose of COVID Vaccine. Patient states approximately one hour after receiving his first dose of the Pfizer COVID vaccine, he began to experience "swelling" in his throat. Patient states he was unable to speak for approximately one minute, so he took a drink of water and the swelling immediately relieved. Patient denies SOB. Patient states he lost his voice for two days following this episode. Patient called PCP to report symptom and his doctor advised patient to discontinue use of antibiotics. Patient states he has had an "uncomfortable sore throat" since discontinuing his antibiotics. Patient denies allergies or medical conditions. Patient due to receive dose 2 of Pfizer on 06/11/2021 at . On 06/11/21, patient consulted with nurse about adverse event following his first dose of Pfizer vaccine. Nurse elevated concerns to next upline nurse. Nurse elevated medical consult to doctor. Patient was given medical clearance from doctor at 3:10 pm. Patient received his second dose of the Pfizer COVID vaccine (Lot #ER8735, Exp 08/2021) at 3:11 pm. Nurse provided patient with education related to when to seek medical care, including shortness of breath, chest tightness, and sensation of throat tightness. The patient demonstrates understanding of teaching and states he will call doctor if he experiences these symptoms.
30 2021-06-10 weakness About 2 days after 2nd covid vaccine I started to get chills, felt like a strong cold, coughed with ... Read more
About 2 days after 2nd covid vaccine I started to get chills, felt like a strong cold, coughed with mucous, skin was very sensitive, had low energy to do anything.
30 2021-06-10 bell's palsy Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male ... Read more
Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171, expiration date not reported), via an unspecified route of administration, administered in Left arm on 30Apr2021 14:00 (at the age of 30-years-old) as 2nd dose, single dose for covid-19 immunisation. Medical history was reported as none and the patient had no known allergies. The patient did not receive other medications in two weeks of vaccination. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8732) via an unspecified route of administration, administered in Left arm on 09Apr2021 14:00 as 1st dose, single dose for covid-19 immunisation. 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 not been tested for COVID-19 since the vaccination. On 21May2021 at 16:00, the patient experienced Bell's palsy and was treated with Antiviral / steroid prescription. The adverse event resulted in emergency room/department or urgent care. The reporter assessed event as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused or prolonged hospitalization, Disabling or Incapacitating, Congenital anomaly or birth defect. The outcome of the events was recovering.
30 2021-06-10 muscle spasms Pain/cramping/tightness in chest around heart area
30 2021-06-10 night sweats, pain in extremity, cold sweat Lost his vision; Breathing almost completely shut down; Severe fever and sweats that night; Ringing ... Read more
Lost his vision; Breathing almost completely shut down; Severe fever and sweats that night; Ringing in his ears; Cold sweat; Severe fever and sweats that night; Could not get up from the chair or move to 40 minutes; Achy; Arm severely sore; This is a spontaneous report from a contactable consumer (parent of the patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration on 09May2021 (Batch/Lot Number: ER8735, at the age of 30 years) as a single dose for COVID-19 immunization at a pharmacy drug store. Medical history included allergies to antibiotics (penicillin and all cross over drugs). The patient has no prior no health issues. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included the patient received the first dose of the BNT162B2 vaccine (Batch/Lot Number: EW0151) on 09Apr2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was reported as none. The patient was not taking any other medications within 2 weeks of receiving the vaccination. On 09May2021, the patient received the second dose of the BNT162B2 vaccine. On 09May2021, the patient had a immediate reaction to the vaccination where his breathing almost completely shut down. He experienced ringing in his ears, lost his vision and had cold sweats. He could not get up from the chair or move for 40 minutes. It was reported that the patient meditates, and he kept his breathing going on his own. The pharmacist assisted him. That night he was achy and had severe fever and sweats. He had to rest for many days. His arm was severely sore and took many days to recover. It was reported that the patient has a very high threshold for pain, but this was severe. The patient has not been tested for COVID-19 after receiving the vaccination. The consumer inquired if the patient should avoid all COVID booster shots next year. The consumer inquired if it possibly this was a polyethylene glycol reaction. No treatment was received for the events. The outcome of event arm was severely sore was recovered in May2021. The outcome of the events loss of vision, breathing almost completely shut down, severe fever, ringing in his ears, night sweats, cold sweats, could not get up from the chair or move and achey was reported as recovering.
30 2021-06-10 pain in extremity Chest pain, pain in left arm
30 2021-06-10 pain in extremity After the first dose the caller's arm was still sore and tight before the second shot; After the fir... Read more
After the first dose the caller's arm was still sore and tight before the second shot; After the first dose the caller's arm was still sore and tight before the second shot; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955), via an unspecified route on 20Mar2021 as 1st dose, single dose in the left arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Mar2021, after the first dose the patient experienced arm was still sore and tight. After the first shot, the patient had arm soreness but nothing that was different from the reports. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
30 2021-06-13 weakness, muscle spasms Light headedness, weakness, and subjective fever onset during the morning of 6/6 following injection... Read more
Light headedness, weakness, and subjective fever onset during the morning of 6/6 following injection of second COVID-Pfizer vaccine on 6/4 at approx. 4:30 p.m, and the initial even also included minor muscular spasms, headache, heartburn, and abdominal pain. These symptoms worsened throughout the day. My pulse felt weak. My breathing became rapid and shallow, even though it was not difficult to draw breath. The major symptoms on 6/7 were headache, with a sense of my motion being affected. My urine throughout this time was excessively dark, even though I was drinking more water than normal. The following day, 6/8, most of my joints began to heart, and I became very stiff; this sx lessened after taking a long, slow walk. On 6/13 another event involving slowed heart rate, subjectively weak pulse, and shortness of breath ensued. There had been no unusual or excessive physical activity, and as I had not experienced this phenomenon before receiving the second vaccine dose on 6/4, I believe that the 6/13 event was also linked to the vaccination.
30 2021-06-13 bell's palsy I got a mild case of Bell's Palsy. My face did not droop but I could not lift the left side of my fa... Read more
I got a mild case of Bell's Palsy. My face did not droop but I could not lift the left side of my face at all. I could not fully smile or flare my nostrils. I also had an earache but no ear infection. I am 10 days into having Bell's Palsy and I have seen an improvement in the movement of my face after one week of Prednisone. But there is still a long way to go before I fully recover.
30 2021-06-13 tenderness Patient came in having tenderness under left armpit. Upon examination, patient had what looked like ... Read more
Patient came in having tenderness under left armpit. Upon examination, patient had what looked like a swollen lymph node. Patient had swelling of about the size of a baseball at left armpit. This was compared to his right side which looked normal. Instructed patient to seek a physician for further examination.
30 2021-06-14 flushing Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild... Read more
Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient experienced excessive sweating; nausea but did not vomit; and also visual changes where for a brief moment his vision was blurred. after elevating his legs and given some orange juice his vision normalized, also given a cool damp cloth to place on his forehead; which control his sweating. All vital signs were within normal limits and checked by nurse practitioner from .
30 2021-06-15 tremor, flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Additional Details: EMTs arrived, patient was already conscious on the floor with feet up, cleared to return home by EMT after checking vitals.
30 2021-06-16 pain in extremity This is a spontaneous report from a contactable consumer (patient) A 30-years-old male patient rec... Read more
This is a spontaneous report from a contactable consumer (patient) A 30-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Mar2021 02:30 (Batch/Lot Number: EL3247) (at the age of 30) as single dose for covid-19 immunisation. The first dose was received on 23Feb2021 03:15 PM in Arm left, Batch/Lot number: EL3247 (at the age of 30). Medical history included anxiety, Raynaud's phenomenon. Concomitant medication included nifedipine taken for an unspecified indication. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm pain on 17Mar2021 09:00, headache on 17Mar2021 09:00, chills on 17Mar2021 09:00, fatigue on 17Mar2021 09:00. No treatment received. The events recovered in Mar2021. No follow-up attempts are possible. No further information is expected
30 2021-06-17 cold sweat Patient reported feeling lightheaded to the nurse. Appeared pale and drowsy according to observers i... Read more
Patient reported feeling lightheaded to the nurse. Appeared pale and drowsy according to observers in the room. Patient unable to speak name to nurse when asked or answer any questions. Skin cold and clammy to the touch. Immediately layed patient down onto cot and elevated feet. Vital signs taken at time of reaction (BP 132/70, HR 57, T 96.9, RR 16, O2 97% RA). Patient stated he was starting to feel better, offered and accepted a glass of water. Patient sat up and denied any dizziness, nausea, or lightheadedness. Vital signs upon leaving (BP 124/76, HR 72, T 97.0, RR 17, O2 99% RA). Patient was able to ambulate independently to the outside accompanied by two nurses.
30 2021-06-18 pain in extremity, numbness, tingling heartrate was faster than normal; tightness in his chest and left arm; tightness in his chest and le... Read more
heartrate was faster than normal; tightness in his chest and left arm; tightness in his chest and left arm; he was kind of laboring to breath; the left side of neck was numb; "pins and needles" sensation from "heads to toes for weeks".; metallic taste; Tired and fatigue; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Apr2021 (lot number: EW0150, expiration date: Jul2021) as single dose for COVID-19 immunization. Medical history included having issues ever since with certain foods and having that reaction ever so often throughout the week. Concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Mar2021 (at the age of 30 years old, lot number: EP6955) as single dose for COVID-19 immunization and after the first dose the patient's arm was still sore and tight before the second shot. On 11Apr2021, the patient experienced arm soreness. The patient experienced metallic taste, tired and fatigued on 12Apr2021. On 19Apr2021, patient reported tightness in his chest and left arm, it was in the left side of his chest, he was kind of laboring to breath, and the left side of neck was numb. He reported that the symptoms were cyclical in nature and that the only thing that's changed in his medical history was the vaccine. On 03May2021, he's also been experiencing a "pins and needles" sensation from "heads to toes for weeks". The patient experienced pins and needles for the last three weeks from the top of his head to his toes, in his fingers, arms, and legs that was also reported as worsened. Patient had been having blood work and x-rays on all of this. None of this was happening to the patient before the vaccines. Also, the patient's heartrate was faster than normal on unspecified date (also reported as on 01Apr2021) and he went to the emergency room on the 19Apr2021. The patient's faster than normal heartrate normally happened in the middle of the night and it woke him up between 2:00 am and 5:00 am. The patient had to walk around and do breathing exercises to slow down his heart rate. After the patient's emergency room visit, the faster than normal heartrate happened roughly around noon and then after that first week, it started earlier around 10:00 am or 10:30 am. The patient went to the emergency room and was admitted and discharged the same day. The patient was in hospital from 19Apr2021 to 19Apr2021 for events tightness in his chest and left arm, it was in the left side of his chest, he was kind of laboring to breath, and the left side of neck was numb, heartrate was faster than normal. Lab data included the patient wore a Holter monitor from 05May2021 to 09May2021. The Holter monitor showed that it was collected normal, normal range, and no issues or symptoms. On 19Apr2021, the blood work and chest X-ray done but both was negative. EKG with result of normal on 19Apr2021. H pylori with result of negative on 02Jun2021. Outcome of events metallic taste, tired and fatigued was recovered on 13Apr2021, while of the other events was not recovered.
30 2021-06-19 nerve pain Severe acute nerve pain, beginning from vaccination site and spreading over the course of several da... Read more
Severe acute nerve pain, beginning from vaccination site and spreading over the course of several days to shoulders, neck and throat
30 2021-06-22 numbness Numbness and complete loss of strength in left tricep and chest muscle
30 2021-06-22 migraine About 2 days after the vaccination I began to have chest pain that would not go away unless I leaned... Read more
About 2 days after the vaccination I began to have chest pain that would not go away unless I leaned forward. It hurt all the time for about 7 days and went away gradually. I believe it to me myocarditis. As well as the above reaction, my migraine frequency went up noticeably from around 10 days a month to 15 or 20. This has not shown any sign of abating and seems to be permanent. Please note that the heart issue went away but the migraine problem definitely has not.
30 2021-06-23 weakness head congestion and cough Acute bronchitis, unspecified organism Office Visit 6/18/2021 WellSpan I... Read more
head congestion and cough Acute bronchitis, unspecified organism Office Visit 6/18/2021 WellSpan Internal Medicine - Dover Internal Medicine Pneumonia due to COVID-19 virus Dx URI Reason for Visit Progress Notes (Physician) ? ? Internal Medicine ? ? Encounter Date: 6/18/2021 ? ? Signed Expand AllCollapse All Assessment/Plan Diagnoses and all orders for this visit: Pneumonia due to COVID-19 virus Other orders - predniSONE (DELTASONE) 10 mg tablet; 10 mg tablets 6 tablets on the first day followed by reducing the dose by 1 tablet each day for 5 more days.6,5,4,3,2,1 - fluticasone propionate (FLONASE) 50 mcg/actuation nasal spray; Administer 2 sprays into each nostril daily He continues to experience fatigue, cough, generalized weakness. Start him on prednisone taper again His insulin need to be adjusted because prednisone can raise his blood sugars. I recommend he contact his endocrinologist regarding this. Advised him not to take hydrocortisone while he is on prednisone. Advised him to monitor his oxygen level at home. I recommend he stay home to rest. No need for quarantine anymore. Stay home to rest until June 27. He can return back to work on June 28 without restrictions.
30 2021-06-23 pain in extremity 30 YO M with no PMH who presented on 4/27 with left arm pain after covid vaccine on 4/15. He reports... Read more
30 YO M with no PMH who presented on 4/27 with left arm pain after covid vaccine on 4/15. He reports he developed left arm swelling and redness that was progressive following the vaccine. He is now s/p I&D at El Camino on 4/28. Patient with multiple apparent debridement sites 3x around elbow and 1x left deltoid. Continues to have pain and swelling around elbow and in shoulder. No sensation changes, compartments are soft. He was subsequently taken to the OR on 5/4 for debridement with return trips on 5/5, 5/6, and 5/7 with vac placed on 5/7. He tolerated bedside vac change to left deltoid and WTD to 3 sites around elbow. He lives at home alone and is unable to do dressing changes by himself. Wound vacs were placed on all wounds and home health was arranged for MWF visits. In addition, he will follow up in wound care clinic as outpatient. He understands he needs to complete course of oral antibiotics and will have pain meds for vac changes. He was stable upon discharge
30 2021-06-23 tingling, burning sensation 3 days after shot got vertigo for about a week. dizzy & lightheaded, problems seeing, vision was dis... Read more
3 days after shot got vertigo for about a week. dizzy & lightheaded, problems seeing, vision was distorted. burning/ tingling in left leg.
30 2021-06-24 weakness 2nd Dose: Experienced first symptoms around 6:00pm on June 24, including severe headache and moderat... Read more
2nd Dose: Experienced first symptoms around 6:00pm on June 24, including severe headache and moderate general weakness. Around 9:00pm experienced mild shortness of breath and moderate lymph node swelling under injection arm armpit which carried into June 25. This report is being submitted on June 25 and the mild shortness of breath and armpit lymph node swelling is still present. 1st Dose: Mild to moderate weakness and fatigue day after the first shot (June 3, 2021) with no additional symptoms. Symptoms completely resolved by June 4.
30 2021-06-25 pain in extremity Left arm sore, stiff, and tired it led me to believe I was having a heart attack and had to go the E... Read more
Left arm sore, stiff, and tired it led me to believe I was having a heart attack and had to go the ER the doctor at the time stated I didn't have a heart attack nor had any visible signs of heart damage
30 2021-06-27 pain in extremity I was immunized with the 2nd dose of the Pfizer COVID-19 vaccines on May 4th, 2021, and on May 5th s... Read more
I was immunized with the 2nd dose of the Pfizer COVID-19 vaccines on May 4th, 2021, and on May 5th started experiencing left shoulder pain radiating to the arm, and upon breathing in pain would intensify. On the night of May 5th pain started to increase and decided to report to the hospital. On May 6th I was admitted to the hospital to further identify what was causing the shoulder pain, deferent test were performed with normal result but upon performing CT Scan, it was identify that I had blood clots on the left lung (pulmonary embolism). Upon several questions asked by the health care team, the doctors at the Hospital stated that the main cause of the blood cloths was the 2nd dose of the Pfizer COVID-19 vaccine due to my healthy status and being the only thing that I had completed different in the days prior to the hospitalization. Due to this I was prescribed a 3 month anti coagulant treatment for the embolism.
30 2021-06-28 seizure R56.9 - Unspecified convulsions
30 2021-06-28 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted on the floor gave him cr... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted on the floor gave him crackers and gatorade fell better called 911 but he refused to go to the hospital. patinet was ok and responsive when he left. He fainted for a few seconds and care was given immediately. patient had no pain or swelling
30 2021-06-29 cold sweat Lighted headed, dizzy, cold clammy skin, history of these type symptoms with injections.
30 2021-06-30 pain in extremity Arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-o... Read more
Arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via unspecified route of administration on 22Mar2021 at 14:00 (at the age of 30-years-old) as a single dose 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 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 an unknown date after first dose, the patient experienced arm soreness. The patient also experienced arm soreness on 22Mar2021 at 16:00. The patient stated that it felt like onset of arm soreness was faster when compared with vaccine 1 and magnitude of pain was seemingly lower than vaccine 1. The patient did not receive any treatment for the event. 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 arm soreness was recovering at the time of report. No follow-up attempts are needed. No further information is expected.
30 2021-07-01 numbness It started out as very bad shoulder pain with a bit of swelling, but shortly after I could feel a ti... Read more
It started out as very bad shoulder pain with a bit of swelling, but shortly after I could feel a tightness when my arm was held all the way outward. The next morning, the top of my ring finger felt numb and as the days progressed it moved to the whole finger and the finger tip of my middle finger as well. I have not regained any of feeling that I lost
30 2021-07-01 pain in extremity Systemic: Patient experienced swelling of left ankle and pain in left foot-Medium
30 2021-07-02 numbness, pain in extremity, nerve pain Injection Site Mild discomfort on 0d . Arthritis Flare up on 7d. Arthralgia, right hand joints swoll... Read more
Injection Site Mild discomfort on 0d . Arthritis Flare up on 7d. Arthralgia, right hand joints swollen, numbness, stiffness. Nerve pain on right arm, left hand joint pain at 8d
30 2021-07-04 feeling hot Patient complained of lightheadedness, slight vision loss, and feeling overheated. This lasted for m... Read more
Patient complained of lightheadedness, slight vision loss, and feeling overheated. This lasted for maybe a few minutes; laying down on his back helped relieve the symptoms.
30 2021-07-05 feeling hot Fever of 100.1, fatigue, slight injection site pain, mild joint pain, mild muscle pain, feeling hot.
30 2021-07-08 muscle spasms myocarditis; Muscle spasms near heart
30 2021-07-10 grand mal seizure, weakness fainted, seizure (grand mal) for 30 seconds, dyspnea, sweating. came to feeling weak, drank water an... Read more
fainted, seizure (grand mal) for 30 seconds, dyspnea, sweating. came to feeling weak, drank water and started feeling better
30 2021-07-11 pain in extremity 8 days post-vaccine I woke up with shortness of breath and mind racing that turned into heart attack... Read more
8 days post-vaccine I woke up with shortness of breath and mind racing that turned into heart attack-like symptoms (shooting pain down left arm, couldn?t breathe, fear of death, lightheaded) and to call ambulance. Cardiologist said that I had inflammation around my heart. Since the medical event I have had four others. Notably, I have never had a history of these types of attacks and they started happening 8 days after first vaccine shot. I am 30 years old, 5?10?, 170 pounds. The vaccine has to have been the cause of these as lifestyle hasn?t changed one bit since vaccination.
30 2021-07-11 tingling, numbness, pain in extremity Bilateral numbness, tingling and pain to arms that started the same day he received his 2nd dose. Pa... Read more
Bilateral numbness, tingling and pain to arms that started the same day he received his 2nd dose. Patient did not have information on 2nd dose of vaccine he received, however states that it was the 2nd dose . Dose was given on 7/8/2021. on left deltoid. He also kept stating it was Moderna? He did not have proof of 2nd dose, only card showing first dose. This report and information on vaccine dose was made with the only information he had at this time.
30 2021-07-12 discomfort Fever, bodily discomfort, chills, burning eyes, nausea. Cold towels were placed to lower his fever.
30 2021-07-12 numbness, tingling 25 Minutes after receiving vaccine he got numbness and tingling in his face, lip, under his eye and ... Read more
25 Minutes after receiving vaccine he got numbness and tingling in his face, lip, under his eye and temple. he also had red whelps on his neck, right arm
30 2021-07-12 migraine I have got a retinal migraine this day. It started by some difficulty to see and focus the vision (1... Read more
I have got a retinal migraine this day. It started by some difficulty to see and focus the vision (15-30 min). Then I got the headache. It was moderate for 1 hr and then relatively low the next hours. I have not had any migraine in the last 3 years. But I got some before in other countries (on or two max per year).
30 2021-07-12 seizure About 30 seconds after injection was administered, the patient's face went blank and their head fell... Read more
About 30 seconds after injection was administered, the patient's face went blank and their head fell back. I took their mask off and they were snoring. I tried to get the patient to the ground and they started seizing and clutching at me. When the patient's knees hit the ground, they came to and asked what had happened. The whole incident took a total of less than 5 minutes. EMTs were called and they checked out the patient and confirmed their vitals were ok. Patient stayed for 30 minutes after incident for monitoring and had returned to normal.
30 2021-07-14 numbness Syncope, hypervetilating, numbness in hands, chest tightness
30 2021-07-17 tingling Approximately 30 minutes after the vaccine administration, my face started to turn red and tingle.; ... Read more
Approximately 30 minutes after the vaccine administration, my face started to turn red and tingle.; Approximately 30 minutes after the vaccine administration, my face started to turn red and tingle.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: unknown) via an unspecified route of administration in left arm on 24Mar2021 at 09:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not applicable. The patient had seasonal allergies to pollen. Concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not tested positive with COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. On 24Mar2021 at 10:15, the patient experienced face red and tingling, approximately 30 minutes after the vaccine administration, the patient's face started to turn red and tingle. The sensation mostly had subsided within 30 minutes after onset. But still, the patient had lingering sensation 2 hours later. The patient had not received any treatment for the adverse events. The clinical outcome of the events faces red and tingling were recovered with sequelae. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
30 2021-07-19 weakness Patient received Pfizer Covid vaccination at pharmacy on 7/20/21 at around 4:15pm. Patient was told... Read more
Patient received Pfizer Covid vaccination at pharmacy on 7/20/21 at around 4:15pm. Patient was told to wait in our waiting area for 15 minutes. Around 10 minutes later, patient was throwing up. He called his mom who works at bakery. She bought him some donuts and gave him water. We checked his blood pressure and it was 111/78. He told us he was feeling dizzy, nauseous, sweating, and felt like his body was shutting down. He gave him an ice pack and told him to lay down. He continued to monitor him for 15 more minutes. He told us he was not feeling any better. His mother told us to go ahead and call 911. We called 911 and the paramedics took him.
30 2021-07-19 feeling hot I also felt like I was struggling to stay conscious./but I had to get up and move around.; I began t... Read more
I also felt like I was struggling to stay conscious./but I had to get up and move around.; I began to start sweating a lot; I felt a warm heat in my body almost like when you get hives. I also felt like I was struggling to stay conscious. I had to get up and use the bathroom and get a drink; I felt a warm heat in my body almost like when you get hives. I also felt like I was struggling to stay conscious. I had to get up and use the bathroom and get a drink; This is a spontaneous report from contactable consumer (Patient). A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection: Lot Number: EW1076) via an unspecified route of administration in left arm on 15Jun202 at 16:00 (at the age of 30-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included the patient had known penicillin allergies. Concomitant medications included methadone, ergocalciferol (VITADONE) both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 15Jun2021 at 16:00, the patient experienced a little nervous because the Agency didn't approve it yet, so I did not know if that what messing with him. After i got the vaccine like 5 minutes after the shot i began to start sweating a lot and i felt a warm heat in my body almost like when you get hives. I also felt like i was struggling to stay conscious. I had to get up and used the bathroom and got a drink but if they would've made him sit in them chairs in the isles, I think I would've passed out. I knew they had them chairs there just in case someone passes out i thought, but i had to get up and move around. The patient did not receive any treatment for the event. The outcome of all events was recovered in 2021.
30 2021-07-20 muscle twitching Vagal syncope- patient passed out, extreme sweating, some muscle twitching, slowing of pulse rate, l... Read more
Vagal syncope- patient passed out, extreme sweating, some muscle twitching, slowing of pulse rate, loss of consciousness Laid patient on ground, propped legs up Duration of 10 minutes before fully regaining consciousness
30 2021-07-27 weakness, numbness, tremor, speech disorder Symptoms that lasted ~12-18 hours; Body Temperature dropped to 90, couldn't warm up for hours, was s... Read more
Symptoms that lasted ~12-18 hours; Body Temperature dropped to 90, couldn't warm up for hours, was shivering/shaking for whole time period; Loss of strength trouble walking collapsed multiple times; Strong; Headache; Loss of Control of Bowels; Vomiting; Brain Fog; Numb Face and issues talking; Issues since then Discomfort in chest at all times.
30 2021-07-27 pain in extremity Chalazion on upper right eyelid starting 5/31/2021 (1.5 months after vaccination). Removed surgicall... Read more
Chalazion on upper right eyelid starting 5/31/2021 (1.5 months after vaccination). Removed surgically on 7/15/2021 (1.5 months after onset). Sharp, stabbing leg pain and hypersensitivity of skin on right thigh starting 7/19/2021 (3 months after vaccination). No treatment, problem persists to present day (7/28/2021).
30 2021-07-28 migraine, muscle spasms Heart Rate in 130's, short of breath, pulse ox 92-93%, low grade fever (99.9-100.5), chills, genera... Read more
Heart Rate in 130's, short of breath, pulse ox 92-93%, low grade fever (99.9-100.5), chills, generalized body aches & cramping, frontal migraine. Fever seemed to occur in early morning (about 01:00 am). By 04:30 am, all of the other listed symptoms were present. Treatment was related to symptom management; 1L of water, Tylenol Cold & Sinus Severe (acetaminophen, phenylephrine, guaifenesin), and sleep.
30 2021-07-28 pain in extremity Entire back hurt; Left arm sore; Left armpit swollen a bit; Cold; This is a spontaneous report from ... Read more
Entire back hurt; Left arm sore; Left armpit swollen a bit; Cold; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male 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 30Apr2021 at 03:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient previously took shellfish. 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 01May2021 at 00:15, the day after shot, the patient experienced that his entire back hurt, on a pain scale it was 6/10, had left arm sore, left armpit swollen a bit and cold most of the day. The clinical outcome of the events entire back hurt, left arm sore, left armpit swollen and cold was resolved on an unknown date on May2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
31 2021-01-04 feeling hot After receiving the vaccine, I was instructed to wait i for 15 minutes to ensure there were no react... Read more
After receiving the vaccine, I was instructed to wait i for 15 minutes to ensure there were no reactions. I sat down in the provided chair, put my headphones in my ears, and started my timer on my watch for 15 minutes. after about 5 minutes I began to feel like my injection arm was a little weak, as if perhaps my arm was stiffening from the injection sore. I remember feeling slightly warm and started to read over the COVID-19 Vaccine symptoms sheet and then I blacked out (Fainted). The nurse in the hallway woke me up and was asking me if i was alright and then rushed me in the back room where they tested me and ensured I was ok. I had not eaten anything the morning of the vaccination shot and barely anything the night before. I have been experiencing higher levels of anxiety recently due to pressures of day to day life; school, work, etc. The nurses are thinking it is likely I had more of a reaction to the anxiety and low food or blood sugar (I am not diabetic), than a reaction to the vaccine itself. They did refer to my experience as sounding like Vasovagal syncope. I have never had this experience with any flu vaccine or shots before; I do not have a fear of needles or shots.
31 2021-01-04 tremor Constant tremors all over, equilibrium off, hypersensitive to noises, fatigue. No treatment. Still... Read more
Constant tremors all over, equilibrium off, hypersensitive to noises, fatigue. No treatment. Still continuing
31 2021-01-05 numbness, hot flush 1/5/21 Within 10 min, started hot flash, right side of face was numb but was not paying attention an... Read more
1/5/21 Within 10 min, started hot flash, right side of face was numb but was not paying attention and went to visit his wife and mother in hospital and came back to the clinic. Noted right facial swelling, right leg felt off, no blurred vison, no difficulty with swallowing. Staff walked to the ED. Gave Benadryl IM given, Steroid IM given. Discharged from ED about 1400
31 2021-01-06 weakness Fever 100.8, shortness of breath, chills, myalgias, weakness, shortness of breath worse with exertio... Read more
Fever 100.8, shortness of breath, chills, myalgias, weakness, shortness of breath worse with exertion, chest tightness
31 2021-01-06 tremor c/o shaking and was pale, per assessment. VSS. RRT assessed. Narrative: pt. noted to be shaking and ... Read more
c/o shaking and was pale, per assessment. VSS. RRT assessed. Narrative: pt. noted to be shaking and had labored breathing when brought to Observation area after vaccination. RRT called and recommended additional 30 min. monitoring. 121/76, P 72, R 20, O2 sat. 98% Discharged in stable condition at 4:15PM.
31 2021-01-07 feeling cold, tingling Started feeling very fatigued around 6/7 PM on 1/7/21. Ate dinner shortly after and took my normal s... Read more
Started feeling very fatigued around 6/7 PM on 1/7/21. Ate dinner shortly after and took my normal sleeping pills as previously listed. Around 12:30 AM on 1/8/21 I woke up feeling very cold. I got up, used the restroom and grabbed some acetaminophen (1000mg). I took the medication and started feeling very dizzy and light headed. After that all I remember is sitting on the kitchen floor feeling like my body was buzzing/tingling. My ears were also ringing really badly. I attempted to get up but was unable to get orientated for what I believe was about 15-30 minutes. I called my BF at 1:10 AM after I was able to get up and moving. I elected not to go to the ER because I didn?t want to directly expose myself to COVID. I stayed up for about another hour, drank some water and ate some crackers. I took 25mg of diphenhydramine and went back to sleep. The rest of the day up to writing this I have been very fatigued and achy. Mild dizziness and confused feeling. I didn?t hit my head but I have about a four inch scrape down my back and a small cut on my foot from the broken glass.
31 2021-01-07 tingling I felt fine the rest of yesterday but started to feel really tired and worn down late last night. I ... Read more
I felt fine the rest of yesterday but started to feel really tired and worn down late last night. I took my sleeping pill like normal and went to bed. I woke up feeling really achy and cold so I went to take some Tylenol in case I had a fever. Started feeling dizzy and light headed and I passed out. I cut my foot on the glass I dropped and scraped my back as I fell. I don?t remember being blacked out very long. I just remember sitting on the floor feeling really lethargic. My whole body felt tingly and my ears were ringing really bad. Was able to get up and get back to bed. Decided to go back to sleep and not go to the ER. This morning I?m still a little dizzy but mostly just have a headache and am extremely tired. I plan to get into my doctor today so I will keep you updated. Just wanted to let you know what happened so you could report it.
31 2021-01-07 tingling Dizziness, NauseaVomiting, Tingling feeling Narrative: Patient returned after 1.5 hours. Monitored ... Read more
Dizziness, NauseaVomiting, Tingling feeling Narrative: Patient returned after 1.5 hours. Monitored an additional 30 minutes. Tingling sensation and nausea diminished. Upon return at 1420: 130/84, HR 79 o2 98%; Recheck 1425: 118-81, HR 73 O2 97%; 1440 120/81, HR 73 O2 98%; 1455 127/85, HR 71 O2 99%. VSS stable. Per patient request, 25mg Diphenhydramine administered by staff Patient sent to ED for further observation.
31 2021-01-07 tingling After administration of the first dose of the COVID19 vaccine (Pfizer) intramuscularly to the left ... Read more
After administration of the first dose of the COVID19 vaccine (Pfizer) intramuscularly to the left deltoid, the patient experienced right hand tingling.  Patient was monitored for 30 minutes, at which point symptoms had resolved. This patient received his second dose of vaccine (from same lot # EH9899) on 1-6-20201 and no adverse reactions were displayed.
31 2021-01-08 weakness, hypersensitivity of all senses Myalgias, Chills, hyperesthesia, Headaches, neck pains, fatigue, weakness. The day after the second ... Read more
Myalgias, Chills, hyperesthesia, Headaches, neck pains, fatigue, weakness. The day after the second dose.
31 2021-01-08 tenderness Persistent but improved tenderness with new swelling noted 3 days after vaccination
31 2021-01-09 pain in extremity Around 6 pm the following symptoms started: Heart rate was as high as 140 Body aches Felt like I ha... Read more
Around 6 pm the following symptoms started: Heart rate was as high as 140 Body aches Felt like I had a fever Felt like pressure on chest Arm was very sore Had chills Nauseous
31 2021-01-10 numbness, hot flush 20 minutes after injection-had hot flash and then right side of face with numbness and then swelling... Read more
20 minutes after injection-had hot flash and then right side of face with numbness and then swelling; no tongue swelling or airway swelling. Was treated in the emergency room at Hospital and was given IV Benadryl and Decadron
31 2021-01-11 pain in extremity Arm pain; swollen and tender supraclavicular lymph node (injection side); swollen and tender supracl... Read more
Arm pain; swollen and tender supraclavicular lymph node (injection side); swollen and tender supraclavicular lymph node (injection side); general fatigue; sinus congestion; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), with the first dose on 15Dec2020 and second dose on 05Jan2021; both intramuscular in the left arm at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy and lactose allergy. Concomitant medications were not reported. 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 05Jan2021, the patient experienced arm pain, swollen and tender supraclavicular lymph node (injection side), general fatigue, and sinus congestion. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious by the reporter. Information on the lot/batch number has been requested.
31 2021-01-12 numbness, tingling 2 days after receiving vaccine employee experienced numbness and tingling in feet which worsened wit... Read more
2 days after receiving vaccine employee experienced numbness and tingling in feet which worsened with rest and improved with waling.
31 2021-01-12 migraine I had body chills fever 103 degree Celsius; body aches; Diarrhea; migraine headache; shivering; This... Read more
I had body chills fever 103 degree Celsius; body aches; Diarrhea; migraine headache; shivering; This is a spontaneous report from a contactable health care professional, the patient. A 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK9231) intramuscular in the left arm on 05Jan2021 at 5:30 PM (at the age of 31-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient did not have any 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. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730), intramuscular, left arm on 17Dec2020 for COVID-19 immunization. On 06Jan2021 at 05:00 AM, the patient experienced body chills fever (103 degree Celsius), body aches, diarrhea, migraine headache, shivering. The events was reported as non-serious. The patient underwent lab test which included body temperature: 103 degree Celsius. The patient did not receive any treatment for the body chills fever (103 degree Celsius), body aches, diarrhea, migraine headache, shivering. The clinical outcome of the events body chills fever (103 degree Celsius), body aches, diarrhea, migraine headache, shivering was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
31 2021-01-12 night sweats pt received vaccine on 1/7/2021. He had soreness at the injection site following the injection. He h... Read more
pt received vaccine on 1/7/2021. He had soreness at the injection site following the injection. He has been having fatigue, malaise, decreased appetite and low grade fevers that occur at night since the injection. He feels fine most of the day but after leaving work mid to late afternoon, feels very fatigued and no interest in evening meal. Low grade fevers in low 100's in the evening and night sweats. has been self medicating with Tylenol for symptoms. No URI symptoms. Hx of COVID 19 virus in July 2020
31 2021-01-12 tingling High blood pressure, tingley fingers, rapid pulse Given 50mg Benadryl
31 2021-01-13 weakness Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection S... Read more
Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; This is a spontaneous report from a contactable Physician (patient). This 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 05Jan2021 15:00 (lot number: EK9231) at single dose in Arm Left for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Migraines. 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 paracetamol (TYLENOL), ibuprofen (ADVIL) occasionally as needed. The patient previously received first dose of BNT162B2 intramuscularly on 16Dec2020 12:00 at 31-year-old (lot number: EH9899) at single dose in Arm Left for COVID-19 immunisation. The patient experienced Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing on 06Jan2021 03:00 AM. The outcome of Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing was recovering. Tylenol, Advil, Bed Rest was received for the adverse events Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing as treatment. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
31 2021-01-13 pain in extremity The evening after the vaccine, Chills, muscle aches and "hung-over" feeling. Approximately 16 hours... Read more
The evening after the vaccine, Chills, muscle aches and "hung-over" feeling. Approximately 16 hours later, arm pain and swollen lymph nodes in injection arm.
31 2021-01-13 pain in extremity Fever more than 100.5F; severe headache; body aches/joint pain; body aches/joint pain; chills; left ... Read more
Fever more than 100.5F; severe headache; body aches/joint pain; body aches/joint pain; chills; left arm soreness; administration date=06Jan2021 dose number=2/administration date=18Dec2020 dose number=1; administration date=06Jan2021 dose number=2/administration date=18Dec2020 dose number=1; This is a spontaneous report from a contactable pharmacist (patient). A 31-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EK9231) via an unspecified route of administration in left arm on 06Jan2021 16:30 at single dose for COVID-19 immunisation. The patient received the first dose of BNT162B2 (Lot: EH9899) on 18Dec2020 16:30 at 31 years old at single dose for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 07Jan2021 06:00 AM, the patient experienced fever more than 100.5F, severe headache, body aches/joint pain, chills, and left arm soreness all lasting 12 hours. Dose received on 06Jan2021 4:30PM and side effects mostly subsided by 07Jan2021 430PM. No treatment was received for the adverse events. Events outcome of fever more than 100.5F, severe headache, body aches/joint pain, chills, and left arm soreness was recovering.
31 2021-01-14 discomfort, numbness, pain in extremity, tingling Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; Left hand tingly/a... Read more
Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; injection site pain; Mild discomfort (2 of 10), but different than arm/injection site pain; This is a spontaneous report from a contactable other healthcare professional (hcp). A 31-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686; 313,121, expiry date not reported) via an unspecified route of administration on 05Jan2021 15:30 at a single dose in the left arm for COVID-19 immunization. Medical history included patient had known allergies to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen (ADVIL) at regular dose, 2 pills, one time in 2 weeks. On 05Jan2021 08:00, the patient experienced left hand tingly/achy/numbness, localized but radiant throughout hand and digits, on-and-off throughout day for past 6 days; mild discomfort (2 of 10), but different than arm/injection site pain, which lasted for 2-3 days. The vaccination was done in a hospital. Patient had a nasal swab test post vaccination (COVID-19 Antigen) on 10Jan2021 and the result was negative. No treatments received in response to the 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 events injection site pain and "mild discomfort (2 of 10), but different than arm/injection site pain" were recovered in Jan2021. The outcome of the event "left hand tingly/achy/numbness, localized but radiant throughout hand and digits" was not recovered.
31 2021-01-15 tingling, numbness Numbness and tingling in left ulnar nerve starting 2 min after injection into left deltoid. 6h after... Read more
Numbness and tingling in left ulnar nerve starting 2 min after injection into left deltoid. 6h after injection began the flu like symptoms: fever 101, systematic joint ache, fatigue, diarrhea, loss of appetite, and sweats. Symptoms lasting for ~38h. Treatment: Tues: nyquil Wednesday: dayquil, advil, and nyquil Thursday by 1030a, 44h after injection did symptoms subsided suddenly.
31 2021-01-16 weakness, muscle spasms Nausea, Vomiting, Fever, Muscle Cramps, Weakness, Shivering.
31 2021-01-16 slurring Patient developed dry heaves followed by angio edema of the tongue, slurred speech. Patient admitted... Read more
Patient developed dry heaves followed by angio edema of the tongue, slurred speech. Patient admitted to the ED and treated with 2 doses of SQ epi, IV pepcid and IV benadryl. Patient recovered and was discharged home with an epi pen.
31 2021-01-16 tingling, tremor, feeling cold Shaking, pulse 110 BPM, tingling/cold sensation in hand, given Benadryl 50 mg, which patient reports... Read more
Shaking, pulse 110 BPM, tingling/cold sensation in hand, given Benadryl 50 mg, which patient reports improved his symptoms
31 2021-01-18 feeling cold Felt head pressure / very cold almost chills for about 4-6 hours same time.
31 2021-01-21 numbness, tingling 3:20pm-patient c/o numbness and tingling in fingertips of left arm. Vital signs taken: 98.4-68-20-98... Read more
3:20pm-patient c/o numbness and tingling in fingertips of left arm. Vital signs taken: 98.4-68-20-98/62. patient alert, oriented x 3. Denies SOB, dizziness or difficulty breathing. bottled water and crackers given. Requested patient wait another 10 mins to be observed. 3:30pm-vital signs: 98.4-70-20-108/60. Remains alert, oriented x3. Denies SOB, dizziness or difficulty breathing. No signs of resp. distress noted. Pt. states feels no worse nd numbness and tingling the same. Pt. states he feels fine to go home and knows to go to ER if start to feel worse. 4:30pm- Called patient. Patient states he feels fine. Numbness and tingling is better.
31 2021-01-21 pain in extremity With both first vaccine (12/28/20 lot EK9231) and second vaccine (1/21/21), about 12 hours after dos... Read more
With both first vaccine (12/28/20 lot EK9231) and second vaccine (1/21/21), about 12 hours after dose I developed a sore arm, headache, chills, nausea, myalgias, fatigue, sweats. After the first done they resolved approximately 36 hours after the vaccine was administered, or about 24 hours after the symptoms began
31 2021-01-26 weakness Chills; weak; hung-over feeling; pain and swollen lymph node under left arm (injection arm); pain an... Read more
Chills; weak; hung-over feeling; pain and swollen lymph node under left arm (injection arm); pain and swollen lymph node under left arm (injection arm); This is a spontaneous report from a contact consumer (patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1283), via an unspecified route of administration on Jan2021 08:00 AM at single dose for covid-19 immunization. Vaccine location was left arm. Patient received the first dose on Dec2020 10:00 AM (lot number EK5730) at left arm for covid-19 immunization. The facility type vaccine was hospital. Known allergies included Penicillin. Concomitant medication included omeprazole. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Chills, weak, hung-over feeling the evening after second dose. Second day, pain and swollen lymph node under left arm (injection arm). The events onset date was reported as 13Jan2021 02:00 AM. Patient didn't receive treatment for the adverse events. The outcome of events was not recovered.
31 2021-01-26 cold sweat First night after second dose of vaccine significant chills and cold sweat lasting all night. Began ... Read more
First night after second dose of vaccine significant chills and cold sweat lasting all night. Began to get better by morning. Early morning muscle and joint paint (1/10)gradual began and increased to a significantly uncomfortable level throughout the day (6/10) along with general malaise. Treated with 600mg ibuprofen at 1500 and 2300. Woke with same type of pain on 1/27/21 (3/10).
31 2021-01-28 discomfort, cold sweat 13 hours after injection: Typical chills, body aches, cold sweats lasting 24 hours. Relief with Acet... Read more
13 hours after injection: Typical chills, body aches, cold sweats lasting 24 hours. Relief with Acetaminophen and Ibuprofen. On 1/25/21 around 4:00 PM: Following intercourse, shortness of breath and mild chest pain. Unable to go for walk with son and wife due to fatigue and mild chest pain. Discomfort ameliorated with rest. On 1/26/21 around 6:00 AM: Shortness of breath and chest pain in shower with minimal effort. Pulse around 140 BPM. Drove to ER for workup. Transferred to hospital for admission.
31 2021-01-31 tenderness Moderate Soreness. Presented 8 hours after vaccination. Contact caused awakening from sleep during ... Read more
Moderate Soreness. Presented 8 hours after vaccination. Contact caused awakening from sleep during the night. Soreness/Tenderness persisted x 24 hours
31 2021-02-01 numbness About one hour after injection developed left facial numbness while I was on my way home. Not full n... Read more
About one hour after injection developed left facial numbness while I was on my way home. Not full numbness, but felling as if coming out of a novocaine shot. Left side chin, lips, cheek extending up to ear/eye. No sign of swelling, droop, redness. Has lasted 2 weeks + and has improved over time but not fully resolved. Now is more an occasional numb feeling mostly in L cheek/lips/corner of L eye. I grind my teeth during stressful times and grind more on my left side so was thinking it could be related to that. Sought medical attention from my doctor who felt said most likely not Bell's palsy related.
31 2021-02-07 feeling hot Feeling unwell and lousy; Feeling warm; Nausea; This is a spontaneous report from a contactable cons... Read more
Feeling unwell and lousy; Feeling warm; Nausea; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at left arm on 21Jan2021 at 12:30 single dose for COVID-19 immunization. The patient medical history included asthma (diagnosed 11 years ago, family history of asthma on mother's side) and pain, both from an unknown date and unknown if ongoing. The patient's concomitant medication included methadone at 75 mg once a day for pain. On 21Jan2021, the patient experienced nausea at 19:00, feeling unwell and lousy and feeling warm at 21:00. The patient's outcome of the events was not recovered.
31 2021-02-10 migraine Onset with fever, chills, body aches, and evolved into prolonged migraine with severe head pain whic... Read more
Onset with fever, chills, body aches, and evolved into prolonged migraine with severe head pain which localized behind eyes. Head pain lasted duration of night.
31 2021-02-16 electric shock sensation Covid Vaccine appeared to be interfering with antidepressants. On 2/16, at 9:00 AM, began experienc... Read more
Covid Vaccine appeared to be interfering with antidepressants. On 2/16, at 9:00 AM, began experiencing brain shocks and very pronounced tics, as well as confusion and extreme depression. Symptoms the same as when decreasing or eliminating sertraline from medication regiment. Went away by 11:00 PM on 2/16.
31 2021-02-16 pain in extremity, nerve pain The day of the vaccine everything was fine sore arm. On the following morning notice rash on the rig... Read more
The day of the vaccine everything was fine sore arm. On the following morning notice rash on the right side of the mouth was flare of shingles on day 7 rash had crusted over. Around 2 more weeks still exp nerve pain right side of the mouth.
31 2021-02-22 seizure like phenomena, tremor 1145 vaccine administered 1147 patient stood up from chair and then had syncopal episode. Fell face ... Read more
1145 vaccine administered 1147 patient stood up from chair and then had syncopal episode. Fell face first onto floor. Hit head on wall trim on the floor. Eyes dilated, fists clinched, arms and legs shaking , not responding to verbal cues. Seizure like activity last approximately 1.5 minutes 1150 called 911 1200 ambulance arrived on scene. patient c/o lightheadedness and needing to continue to lay down 1210 transported patient to ER at Hospital
31 2021-02-26 face paralysis History of Present Illness 31-year-old male with no past medical history presenting with left-si... Read more
History of Present Illness 31-year-old male with no past medical history presenting with left-sided facial weakness after receiving the first dose of the COVID-19 vaccination 2 days ago. States that several hours after receiving the vaccination he noticed left-sided tongue numbness. He was able to tolerate oral intake without difficulties and handle his secretions. The following day his wife noticed facial asymmetry of his lip left side of his face involving his forehead. Patient is denying any extremity numbness or weakness, head injury, trouble speaking, confusion. No recent travel or skin changes. No similar reaction to vaccinations in the past.
31 2021-02-27 pain in extremity Pain in arm for 2 days 24 hours after injunction full 24 hours of sleep. I went to sleep at normal ... Read more
Pain in arm for 2 days 24 hours after injunction full 24 hours of sleep. I went to sleep at normal time Tuesday night woke up at normal time Thursday morning. Same with Friday went to sleep normal time on Thursday woke up Saturday morning then Saturday night could not fall asleep at all.
31 2021-03-04 weakness 102 degree fever, body aches, severe chills, lethargy, weakness, muscle aches, fatigue, swollen lymp... Read more
102 degree fever, body aches, severe chills, lethargy, weakness, muscle aches, fatigue, swollen lymph nodes. Rested in bed for 4 days, felt better on the fifth. I feel an onset of similar symptoms today 03/05/2021, 17 days after 2nd vaccine dose.
31 2021-03-04 bell's palsy I was suffering from paralysis and numbness on the left side of my face. I went to the ER and was d... Read more
I was suffering from paralysis and numbness on the left side of my face. I went to the ER and was diagnosed with Bell's Palsy; This is a spontaneous report from a non-contactable consumer (the patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) via an unspecified route of administration in left arm on 21Feb2021 11:30 a.m. at age of 31-year-old, at single dose for COVID-19 immunisation. The patient had history of frequent ear infections. Concomitant medication included fluticasone which was taken within 2 weeks of vaccination for an unspecified indication. 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 the vaccination. The patient reported when he woke up the next day after receiving the vaccine (22Feb2021), he found that he was suffering from paralysis and numbness on the left side of his face. He went to the emergency room (ER) and was diagnosed with Bell's Palsy. He had been experiencing some minor pain in his left ear beginning two days before he received the vaccine (i.e., three days before onset of facial paralysis), and this ear pain had continued as he continue to experience the palsy. Since visiting the ER, he had also seen a neurologist. The doctors he had seen do not necessarily think that the palsy resulted from receiving the vaccine. The onset date of the event "I was suffering from paralysis and numbness on the left side of my face. I went to the ER and was diagnosed with bell's palsy" was reported as 22Feb2021 09:00 a.m. The event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The event was non-serious (the event did not result in death, not life threatening, not caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect). Oral steroid and antiviral drugs, eye ointment was received to treat the event. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
31 2021-03-07 discomfort, migraine Extreme migraine, nausea/vomiting, fever/chills, fatigue, muscle soreness, aching of joints, sensiti... Read more
Extreme migraine, nausea/vomiting, fever/chills, fatigue, muscle soreness, aching of joints, sensitivity to light/sounds, and weighted sensation.
31 2021-03-11 feeling hot Pt received vaccine. Pt was light headed, dizzy and feeling hot 15 min post vaccine. Crew arrived to... Read more
Pt received vaccine. Pt was light headed, dizzy and feeling hot 15 min post vaccine. Crew arrived to pt. Vitals assessed. Crew brought pt to ambulance. ALS assessment and fluids given due to hypotension. Transport to hospital.
31 2021-03-13 cold sweat Mild flu like symptoms starting around 9 hours after dose - cold sweats, muscle aches, nausea.
31 2021-03-15 hot flush Severe fatigue; headache; chills; hot flashes; This is a spontaneous report from a non-contactable o... Read more
Severe fatigue; headache; chills; hot flashes; This is a spontaneous report from a non-contactable other healthcare professional. A 31-year-old (age at the time of vaccination was 31-year-old) male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via intramuscular route of administration on 03Feb2021 12:00 PM at single dose in right arm for COVID-19 immunisation at clinic. The patient medical history and concomitant medications were not reported. It was reported that the patient had not received COVID prior vaccination. The patient experienced severe fatigue onset 24 after receiving shot on 04Feb2021; duration 48 hours. Included headache, chills, and hot flashes on 04Feb2021. Treatment was not received for adverse events. No other vaccine in four weeks. The patient was not tested for COVID post vaccination. The outcome of all events was recovering. No follow-up attempts are possible. No further information is expected.
31 2021-03-16 feeling of body temperature change Stinging feeling in my left eye lid and face. Progressively got worse. Change in feeling and tempera... Read more
Stinging feeling in my left eye lid and face. Progressively got worse. Change in feeling and temperature on the left side of the face between my eyebrows and chin.
31 2021-03-17 feeling cold Shivers Chills Fever Extreme cold Fatigue Nausea
31 2021-03-18 flushing 3/19/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination... Read more
3/19/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: . Complained of a heart racing and feeling flushed Assessment : Time of assessment. 0920a Actions taken: Vitals sign taken BP- 121/78. HR- 94, O2 - 100%. Recheck at 0921- 78 Waited in observation 30 mins Medications administered: No medication administered. Disposition:The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/19/2021 9:11 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8727 NDC: 59267-1000-1 Electronically signed by , RN at 3/19/2021 11:52 AM Immunization on 3/19/2021
31 2021-03-23 migraine First shot left me with a fever of 102 for two days, plus being chilled and migraine. Second shot le... Read more
First shot left me with a fever of 102 for two days, plus being chilled and migraine. Second shot left me with a fever of 100.5, chilled, and migraine.
31 2021-03-24 tenderness Swollen Lymph node in left arm pit. Sensitive to touch, sore. Development was about 24 hours after r... Read more
Swollen Lymph node in left arm pit. Sensitive to touch, sore. Development was about 24 hours after receiving the 2nd dose. Other side effects were headaches and fatigue. Took Tylenol for that twice.
31 2021-03-25 feeling hot, tingling, flushing Pt c/o feeling warm and flushed after receiving vaccine. Also reported "tingling" sensation in Lt fi... Read more
Pt c/o feeling warm and flushed after receiving vaccine. Also reported "tingling" sensation in Lt fingers. Pt was reclined in seat and given pretzels and poweraide to drink. Medical director notified and pt Observed for additional 30 minutes. Initial bp 98/55 p- 44. Aftere reclining in seat BP 117/67 P-68, after eating/drinking and waiting 30 minutes BP 120/71 P-61. before being released pt denied any symptoms and was driven home by wife.
31 2021-03-26 feeling cold, pain in extremity Had a sore arm starting around 9am. Around 3am I woke up freezing and shivering uncontrollably. This... Read more
Had a sore arm starting around 9am. Around 3am I woke up freezing and shivering uncontrollably. This co tinued until about 7 or 8 am. Currently At 130pm 24hrs after receiving my body aches, mild headache, and pretty tired.
31 2021-03-29 hot flush, pain in extremity, migraine Sore arm, chills and hot flashes, headache/migraine, body aches. Fully recovered.
31 2021-03-29 unresponsive to stimuli Patient fell out of chair and was unresponsive about 10 minutes after vaccination. When able to talk... Read more
Patient fell out of chair and was unresponsive about 10 minutes after vaccination. When able to talk complained of itching all over. EpiPen was administered. During fall landed directly on face resulting in laceration to nose and subconjunctival hematoma to left eye. Patient continued to be alert and responsive and itching resolved with EpiPen. He was transported by ambulance to Emergency Department.
31 2021-03-30 burning sensation Muscle and joint pain in my hips. Burning sensation in my legs that lasted about 5 hours through the... Read more
Muscle and joint pain in my hips. Burning sensation in my legs that lasted about 5 hours through the night
31 2021-03-30 tingling Tingling - much like the sensation of novocain wearing off - from the injection site on my left shou... Read more
Tingling - much like the sensation of novocain wearing off - from the injection site on my left shoulder to my left cheek. The sensation is most noticeable on my left shoulder ( injection site), left neck, and left cheek (from jaw to cheekbone)
31 2021-03-30 seizure PATIENT HAD SEIZURE IN WAITING AREA AFTER RECEIVING FIRST DOSE OF COVID VACCINE. PT BECAME RESPONSIV... Read more
PATIENT HAD SEIZURE IN WAITING AREA AFTER RECEIVING FIRST DOSE OF COVID VACCINE. PT BECAME RESPONSIVE, EMS WAS CALLED AND MANAGED PATIENT AFTER
31 2021-03-31 pain in extremity Caller stated he got Pfizer vaccine on 3/36, and later that day arm was sore, and had fatigue, but t... Read more
Caller stated he got Pfizer vaccine on 3/36, and later that day arm was sore, and had fatigue, but that both are gone now. He stated he started coughing the same day and is still coughing. He denies any other symptoms. No lot number was available at this time.
31 2021-04-01 pain in extremity, hot flush Woke up with large headache and nausea, chills and hot flashes. Severe throat pain and fatigue with ... Read more
Woke up with large headache and nausea, chills and hot flashes. Severe throat pain and fatigue with chills throughout the day, arm pain and lymph node swelling, joint pain
31 2021-04-02 tingling 5 days after vaccination, left arm got progressively more sensitive to the tough. Rash appeared alon... Read more
5 days after vaccination, left arm got progressively more sensitive to the tough. Rash appeared along spinal column, on chest, and on left shoulder blade by day 6 after vaccination. Rash turned more pustular, with increased sensitivity and needling feeling. On day 9, diagnosed with herpes zoster reactivation (shingles).
31 2021-04-05 pain in extremity First Dose - 3/15/2021 - No side effects other than a sore arm. Second Dose - 4/5/2021 - Drowsy appr... Read more
First Dose - 3/15/2021 - No side effects other than a sore arm. Second Dose - 4/5/2021 - Drowsy approximately 11 hours after injection. Body Aches, Chills, Fever began approximately 13 hours after the injection and lasted for 9 hours. Morning of 4/6/2021. Fever and chills have cleared but still experiencing body aches and stiffness.
31 2021-04-06 weakness injection site ache from time of injection that has not subsided, general body ache onset from appro... Read more
injection site ache from time of injection that has not subsided, general body ache onset from approximately an hour after injection that has not subsided, general body weakness onset within 12 hours after injection that has not subsided, headache onset from approximately 15 hours after injection that has not subsided, dizziness onset approximately 19 hours after injection that has not subsided, fever onset approximately 24 hours after injection
31 2021-04-07 burning sensation Extremely lethargic, sore throat, chills, achiness, nausea, dizziness, congestion, runny nose, burni... Read more
Extremely lethargic, sore throat, chills, achiness, nausea, dizziness, congestion, runny nose, burning sensation in lungs, coughing, asthma attack, swollen lymph node under arm with injection
31 2021-04-07 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted after getting his pfizer shot. he was sweating.
31 2021-04-07 tingling, weakness Pfizer-BioNTech COVID-19 Vaccine EUA About a minute after the shot I experienced dizziness, weakness... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA About a minute after the shot I experienced dizziness, weakness and a bad headache. I also become very nauseous, had injection site numbness, a tingling feeling in my fingertips, lower back pain/joint pain and felt sick the rest of the day.
31 2021-04-08 cold sweat directly after injection, patient felt like he was going to pass out, tunnel vision, assisted to flo... Read more
directly after injection, patient felt like he was going to pass out, tunnel vision, assisted to floor by staff, feet placed up on chair. arrived to obs, admits to needle phobia/anxiety. clammy, diaphoretic and pale. bp 110/72 hr 55 rr 18 sats 99% on ra. placed in tredelenberg, states relief, color returned and sweating ceased. water and apple juice provided. 5 mins later bp 117/78 hr 59 rr 18 sats 100%. patient sitting up on side of bed 5 mins later bp 127/89 hr 65, then standing bp 118/65 hr 55. states he feels back to baseline and escorted to vehicle with no issues.
31 2021-04-09 weakness Monday afternoon 3/22/2021 I received the vaccine. The next day (23rd) I had dizziness and nausea st... Read more
Monday afternoon 3/22/2021 I received the vaccine. The next day (23rd) I had dizziness and nausea started with stomach grumbling. 24th worsening nausea with some very green loose stools, still dizzy and started feeling fever, chills and then began loss of appetite. By the 25th & 26th my condition had worsened. still had fever and chills, nausea & lost appetite (could not eat anything). I was only drinking fluids by this time and I felt extremely fatigued and spent most of Thursday and Friday in bed recovering. By Friday I contacted my doctor, who said to go to urgent care if I didn't feel better on the weekend. Saturday my condition was the same and still on Sunday I was not any better. By Sunday, I took myself to urgent care, upon arrival, pulse was 124 with a temperature of 100.2F .. the worst symptoms for me were all body weakness/fatigue & fever/chills & nausea. I was prescribed medicine for the nausea and tested negative for covid. In all it was almost 2 weeks before I felt recovered from the vaccine.
31 2021-04-09 migraine, pain in extremity, hot flush Headache; migraine; Sore arm; Body aches; Hot flashes; chills; This is a spontaneous report from a c... Read more
Headache; migraine; Sore arm; Body aches; Hot flashes; chills; This is a spontaneous report from a contactable consumer (patient himself). A 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 31 years, at single dose in left arm on 24Mar2021 at 18:00 (Lot number: EN5318) for COVID-19 immunisation. Medical history was not provided. Concomitant medications included fluoxetine and oxymetazoline hydrochloride (CLARITIN ALLERGIC) both taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose in left arm on 02Mar2021 at 18:00 (Lot number: EN5318) for COVID-19 immunisation. The patient experienced headache/migraine, sore arm, body aches, hot flashes and chills on 25Mar2021 at 04:00. The patient had no Covid prior to vaccination and no Covid tested post vaccination. There was no treatment received. Events outcome was recovered. No follow-up attempts are needed. No further information is expected.
31 2021-04-10 flushing Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed ... Read more
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
31 2021-04-11 feeling hot pt c/o lightheadedness and vision turning white; pt able to ambulate with 2 guards at his side to pr... Read more
pt c/o lightheadedness and vision turning white; pt able to ambulate with 2 guards at his side to private obs room; wife present; pt placed on exam table and HOB put flat and legs elevated; eyelids fluttering, pt warm and diaphoretic; remained responsive and answering questions; pt states that he has fainted in the past, also has "sensitivity" to certain anesthetics; initial VS at 1013:cuff not registering BP, HR 38/dinamap,RR 18,Sao2 100%. Switched to smaller BP cuff and Vs at 1015: BP 78/43,HR 40,RR 18, Sao2 100%. Pt c/o nausea. VS at 1020: 98/51, HR 58, RR 18, SaO2 100%. Pt states that he is feeling better except still nauseous. VS at 1025: BP 112/59, HR 68, RR 16, SaO2 100%. HOB raised to 45 degrees, no c/o. Pt given cold pak and drink of water. 1030:pt states less nauseous, still "cloudy". 10:45:HOB placed at 90 degrees, BP 114/67, HR 66, RR 16, SaO2 98%. 10:50:pt states that he is feeling much better, talkative, ambulated WNL in room. 1055: BP 112/72, HR 56, RR 16, Sao2 100%. Pt states that he feels a "little tired" but fine to leave. Wife will drive pt home. 1100 Pt leaves clinc; no c/o.
31 2021-04-11 numbness, pain in extremity Today, 9 days later I have pain in arm, and numbness in my hands on the side where I got my shot. Ne... Read more
Today, 9 days later I have pain in arm, and numbness in my hands on the side where I got my shot. Neck pain and leg pain on the side that I got the shot. Joint pain on the side where I got my shot.. Slight Cough.
31 2021-04-11 pain in extremity Mild arm soreness
31 2021-04-11 pain in extremity Pfizer Covid 19 vaccine vial was mixed with 1.4 instead of 1.8 ml of diluent and a dose was administ... Read more
Pfizer Covid 19 vaccine vial was mixed with 1.4 instead of 1.8 ml of diluent and a dose was administered to patient. Spoke to patient 04/11/2021 and he reported having a sore arm. Provided counseling.
31 2021-04-11 tingling Dry mouth, tingling in face, slight blurry vision (anxiety)
31 2021-04-12 weakness Severe energy drain, soreness, headaches, difficulty concentrating.
31 2021-04-12 numbness PT CALLED INTO STORER AND SPOKE TO PERSON AND SHE CALLED US SINCE PT GOT VACCINE AT THATLOCATION. PT... Read more
PT CALLED INTO STORER AND SPOKE TO PERSON AND SHE CALLED US SINCE PT GOT VACCINE AT THATLOCATION. PT TOLD PERSON HE HAD NUMBNESS IN HIS THIGH AND CHEST. SHE TOLD PT TO CALL HIS MD
31 2021-04-13 pain in extremity Received the vaccine on Saturday, 4/10/2021 at around 12p. On Sunday, 4/11/2021 woke up around 11am ... Read more
Received the vaccine on Saturday, 4/10/2021 at around 12p. On Sunday, 4/11/2021 woke up around 11am with a fever and feeling extremely run down. In addition had no appetite and somewhat nauseas. On Monday morning around 10am, felt better with no fever yet still less of an appetite. Through out the day kept improving and then at 12:30a Tuesday, 4/12/21 I began to get hives on my inner thighs, arms, feet, buttocks which started to rapidly spread to all over my body. After about an hour my lips swelled up and the hives were puffier and immensely itchy and painful including my arms and feet. On
31 2021-04-15 muscle spasms 31 Y/O MALE WITHA PMHX OF GERD CONTROLLED DAILY WITH OMEPRAZOLE AND RANITIDNE, PRESENTS POST COVID V... Read more
31 Y/O MALE WITHA PMHX OF GERD CONTROLLED DAILY WITH OMEPRAZOLE AND RANITIDNE, PRESENTS POST COVID VACCINE 4/12 PFIZER # 1 WITH EPIGASTRIC BURNING 10/10 CONSTANT, SEVERE SWEATING, SOAKING TSHRTS 3 AT NIGHT AND SWEATING NONSTOP DAILY, INSATIABLE HUNGER, MUSCLE CRAMPS TODAY ONLY. HAS BEEN PRESENT SINCE WEDNESDAY BUT WORSENED TODAY/ n. Pt states he takes Omeprazole, Tums, and Pepto. Pt states Pepto relieved his symptoms temporarily. Pt states he is nausea, but denies vomiting and diarrhea. Pt rates pain 10/10. EP PAIN IS CONSTANT, DENIES FEVER ., ADMITS URINARY HESTANCY BP 173/117 HR 113 DIAPHORETIC, SEVERE PAIN
31 2021-04-15 tremor PATIENT WALKED UP TO THE COUNTER AREA AND STATED HE WAS FEELING LIGHTHEADED AND DIZZY. HE SAT DOWN, ... Read more
PATIENT WALKED UP TO THE COUNTER AREA AND STATED HE WAS FEELING LIGHTHEADED AND DIZZY. HE SAT DOWN, THEN BEGAN TO SHAKE AND START SWEATING. I STAYED WITH HIM AND MONITORED HIM, PARAMEDICS WERE CALLED. AFTER 3-4 MINUTES, THE PATIENT SAT UP AND BEGAN TO FEEL BETTER.
31 2021-04-15 unresponsive to stimuli, flushing, tremor Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Pt urinated while unconscious-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: Pt reported no feeling well. Denied trouble breathing/swallowing. Pt lost consciousness. We were able to prevent him from falling or any\r\ninjury. 911 was called. He was out about 15 seconds. Regained consciousness. Was startled and confused but was quickly became reoriented to where he was, that he had just recieved vaccine and passed out. Patient's BP and condition was monitored until paramedics arrived. After coming around patient started to feel nauseous and felt like he would vomit.
31 2021-04-16 tingling received vaccine, soon felt woozy, heart pounding, lips and fingers tingling, dizziness, reported to... Read more
received vaccine, soon felt woozy, heart pounding, lips and fingers tingling, dizziness, reported to staff, brought back via wheelchair to obs at 0855. placed on stretcher in trendelenberg, states felt better moments after. snack and water given, instructed on hyperventilating and exercises to reverse this with controlled breathing. sig other at bedside, when symptoms resolved, patient and sig other escorted to exit without issues at 0920. 0855 intial/trendelenberg bp 139/85 hr 108 sats 100% on ra rr 22 0900 sitting bp 146/87 hr 106 sats 97% ra rr 20 0915 standing bp 130/85 hr 79 sats 98% ra rr 20
31 2021-04-17 burning sensation About 30 to 60 second after, burning sensation spreading from injection point. Within about 5 minute... Read more
About 30 to 60 second after, burning sensation spreading from injection point. Within about 5 minutes light headedness, shortly after confusion occurred. About 10 minutes after a headache start and mild nausea. Headache and nausea progressively got worse, while light headedness and confusion stayed about the same. Lightheadedness and confusion subsided about 4 to 6 hours later. Nausea and headache continued for 5 to 7 days. A sore throat and stuffy nose developed about 2 days after receiving the vaccine, and continued for 3 to 4 days.
31 2021-04-17 slurring, numbness I felt numbness in my right leg, the numbness went up to my right arm and then I started slurring. T... Read more
I felt numbness in my right leg, the numbness went up to my right arm and then I started slurring. This happened within a few minutes. I laid down and called a nurse adviser. I was recommended to go to ER, so my wife took me to ER. They did CT scan of my head, then CT scan of my head and neck with contrast, then MRI of my head, then MRI of my head and neck with contrast. It was confirmed that I had an ACUTE ISCHEMIC STROKE. It was decided to perform carotid endarterectomy surgery to remove a clot in the neck carotid artery. The clot was removed.
31 2021-04-18 numbness Loss of circulation in left and right hands, fingers and thumbs falling asleep frequently. Very simi... Read more
Loss of circulation in left and right hands, fingers and thumbs falling asleep frequently. Very similar to Raynaud's disease symptoms. Started 5 minutes after shot and lasted for two weeks.
31 2021-04-18 tingling, numbness, feeling cold - 4/17/21, ~4:30 pm: 1st dose of Pfizer COVID?19 vaccine - 4/17/21, ~7:30 pm: Tingling in face, more... Read more
- 4/17/21, ~4:30 pm: 1st dose of Pfizer COVID?19 vaccine - 4/17/21, ~7:30 pm: Tingling in face, more concentrated on left side of face. - 4/17/21, ~8:30 pm: ER visit upon recommendation of a nurse phone line. During the ER visit, the tingling turned into numbness (novocaine like feeling). There was also tingling in front left of tongue. Benadryl was given (tongue tingling seemed to go away with Benadryl but nothing else) and sent home ~11:30 pm. The ER doctor advised coming back if symptoms got worse.
31 2021-04-20 pain in extremity 24-48 hours post injection, pt experienced a sore arm consistent with other immunizations which reso... Read more
24-48 hours post injection, pt experienced a sore arm consistent with other immunizations which resolved shortly thereafter. 9 days post immunization, pt experienced pain and inflammation in the area of the injection. Symptoms included radiating pain into the scapular area, mimicking that of a labral tear. Pt continues to experience pain/inflammation at the site of the injection that continues to radiate and feels like a fatigued arm with excessive movement (as of today (Day 14)).
31 2021-04-20 tingling, numbness, pain in extremity On 4/19 he received the first dose of Pfizer vaccine oh 4 PM. Administration of vaccine was unevent... Read more
On 4/19 he received the first dose of Pfizer vaccine oh 4 PM. Administration of vaccine was uneventful. The next day he noticed sore shoulder at 3 PM on 4/20 he noted he had upper wrist pain that progressed to his right thumb as well as redness with a shiny quality that was consistent with previous gout flares so he took 2 doses of colchicine and 2 doses of Advil which did not relieve his symptoms. A couple hours later he noted hand numbness and tingling as well as feet numbness and tingling bilaterally. The numbness progressed to his extremities with the left arm more affected than the right arm (he received vaccine in his left arm). He had accompanied pain of his extremities and wrists that was described as 10 out of 10. He then felt 2 episodes of chest tightness and difficulty breathing prompting him to present to the strong ED. In the ED his exam was notable for hypertension (240/90), tachycardia, wrist flexion in distress and yelling in pain. His exam also showed bilateral hyperflexion of bilateral wrist with mild swelling and diminished sensation and motor function throughout. He was administered IV hydromorphone, and Benadryl with dramatic improvement in his symptoms. His labs are notable for abnormal electrolytes including magnesium, potassium, phosphorus, calcium and he was repleted with magnesium potassium and phosphorus. He is admitted to ED OBS. overall felt his symptoms were most likely due to gout flare and hyperventilation, not likely related to vaccine.
31 2021-04-21 feeling cold At 0632 patient woke up to go to the bathroom, felt dizzy, and fainted on the floor face down. I aw... Read more
At 0632 patient woke up to go to the bathroom, felt dizzy, and fainted on the floor face down. I awoke from the noise and found him trying to stand up. At about 0634 patient fainted again. I brought him to lay down on his back on the floor. No seizure-like activity or loss of consciousness. Pulse was thready but resolved after about 5 minutes. Had patient lay on back and elevate lower extremities. Patient felt chilly and fever-ish, but was not able to get reliable temperature at this time.
31 2021-04-21 tingling, weakness The BNT 162 B2 vaccine was administered on the morning of Monday January 4th 2021 at approximately 1... Read more
The BNT 162 B2 vaccine was administered on the morning of Monday January 4th 2021 at approximately 11:08am, via intramuscular route. Within the next 24 hours, I started having myalgia and Paresthesia to my right leg and foot on 1/5/21, this progressively worsened. On the 6th January, the paresthesia worsened and started to occur on the left foot- anterior and dorsal surfaces. In addition, at about 21:45hrs, I started having lower back pain- severe, rated about 6/10 in severity. This progressively worsened to 10/10 in pain severity. On the 7th an, all my symptoms had worsened, despite taking Tylenol. On the 8th January 2021, I started having difficulty lifting my right foot and visited emergency room for further care. At that time I have had a series of investigations and lab work done, in addition to PCP and specialist referral including Neurologist, Physiatrist and for Physical therapy. I am still undergoing physical therapy with improvement in the weakness but I still have persistent and on going lower back pain and paresthesia in my legs and foot three months later.
31 2021-04-21 tingling, numbness VACCINE ADMINISTERED AT 10:19, AT 10:22 PT C/O DIZZINESS AND REPORTED NUMBNESS AND TINGLING IN BOTH ... Read more
VACCINE ADMINISTERED AT 10:19, AT 10:22 PT C/O DIZZINESS AND REPORTED NUMBNESS AND TINGLING IN BOTH EXTREMITIES. PT WAS GUIDED TO A FLAT SURFACE IN A SUPINE POSITION WITH LEGS RAISED UP ON THE CHAIR. COLD ICE PACK WAS APPLIED AT THE BACKOF HIS NECK, SLOW DEEP BREATHS ENCOURAGED. VITALS INCLUDED; 108/68, 74BPM, RR=16. AT 10:27 AM PT REPORTED SYMPTOMS HAD SUBSIDED. PT WAS OBSERVED FOR 20 MORE MINUTES AND D/C WITH NO MORE SYMPTOMS OBSERVED OR REPORTED.
31 2021-04-21 unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Med... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Additional Details: Fainted, lost consciousness and fell to floor. Hit head and had redness above eye brow. Patient said he had anxiety surrounding needles. Wife will bring to ER
31 2021-04-22 feeling hot Extremely minor allergic reaction to injection. Within minutes of injection I had a red butterfly sh... Read more
Extremely minor allergic reaction to injection. Within minutes of injection I had a red butterfly shaped fash in my cheeks. The rash was very warm to the touch and my face felt warm in general. I developed no further symptoms of an allergic reaction, and the rash went away within 2 hours untreated.
31 2021-04-22 flushing 3 MINUTES AFTER RECEIVING THE VACCINE, HE FELT FLUSH AND DIFFERENT THAN EVER BEFORE. ON SITE EMS RES... Read more
3 MINUTES AFTER RECEIVING THE VACCINE, HE FELT FLUSH AND DIFFERENT THAN EVER BEFORE. ON SITE EMS RESPONDED AND VITALS ARE BELOW. 25MG DIPHENHYDRAMINE WAS GIVEN. HE WAS MONITORED AND RELEASED TO HOME
31 2021-04-23 unresponsive to stimuli, seizure At 10 am on 4/23/21, the patient received his second Pfizer dose and became unresponsive and started... Read more
At 10 am on 4/23/21, the patient received his second Pfizer dose and became unresponsive and started to seize. He was sitting in the waiting area to be monitored when this occurred. The nurse and I went to assist him and I told staff to call 911. The patient quickly became responsive and said that he was fine and I told staff to cancel the call for an ambulance. I could tell he was shaken up and I asked him about any pertinent medical and medication history. He says he has high blood pressure but took his medication that day. He did not eat or drink anything and we gave him water and a granola bar to eat while he was waiting for his family member to pick him up. I recommended he call his provider to inform him or her what had happened and to report the side effect to VSAFE. I checked his blood pressure and it was 159/90 which was considered normal for him. His brother arrived and was thankful for the help.
31 2021-04-24 facial paralysis, face paralysis drooping face; complaining of right facial weakness; has difficulty closing right eye; headache; nec... Read more
drooping face; complaining of right facial weakness; has difficulty closing right eye; headache; neck pain; hard to get into sleep last night; This is a spontaneous report from a non-contactable Other-Healthcare professional. A 31-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Pfizer, Formulation: Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration on 16Mar2021 (age at vaccination 31 years) at single dose for Covid-19 immunization. Reportedly, there were no known allergies to medications, food or other products other medical history. Patient did not have COVID prior to vaccination. Patient was not tested for COVID post vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was complaining of right facial weakness since 04Apr2021 (the day before yesterday), drooping face, has difficulty closing right eye. It was associated with headache, neck pain. The neck and headache pain scale was 7/10 for 4-5 days. It was reported that pain comes and goes. The headache was less when he works and exercise. But the headache was more severe at night. It was hard to get into sleep last night. There was no n/v/c/d, blurred vision, cp, sob, doe, fever, chills, cough, sore throat, runny nose, etc. There was no rash, numbness. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The reporter assessed the case as non-serious with no seriousness criteria (Seriousness criteria-Results in death/ Seriousness criteria-Life threatening/ Seriousness criteria-Caused/prolonged hospitalization/ Seriousness criteria-Disabling/Incapacitating/ Seriousness criteria-Congenital anomaly/birth defect). No treatment was given for adverse events. Outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of drooping face 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 2021-04-24 flushing Lightheaded, flushed/sweating. Offered water and juice. BPs 96/63 (pulse 70), 102/65 (pulse 68).
31 2021-04-24 numbness Left side, arm, chest and face felt very swollen and numb. No visible swelling or redness or hives o... Read more
Left side, arm, chest and face felt very swollen and numb. No visible swelling or redness or hives or anything Started about 20 minutes post vaccine and lasted about an hour
31 2021-04-24 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receiving shot. Wi... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receiving shot. Wife caught him and he was laying on the ground for about 20 seconds and woke up. Wife says this happens after he gets shots. He gets light-headed and faints. After 5 minutes he got up and sat in the waiting area and after 20 minutes he felt okay and went home
31 2021-04-25 feeling hot, flushing Sweaty, flushed, warm, dizzy, blurred vision.
31 2021-04-25 tingling, numbness 45 min after the shot my left foot went numb, a couple days later my left hand also went numb. Shoul... Read more
45 min after the shot my left foot went numb, a couple days later my left hand also went numb. Shoulders and neck became stiff. after 2 weeks numbness started to fade but now have tingling sensation instead and still on going after 5 weeks. Neck pain has still not subsided after 5 weeks. I have been to 5 Dr appointments so far with no conclusion or fix.
31 2021-04-26 tingling 4 days post vaccine woke with difficult with visual focus. Over the next 2 weeks, progressed to ocu... Read more
4 days post vaccine woke with difficult with visual focus. Over the next 2 weeks, progressed to ocular pain with diplopia. Also with paresthesia in hands and feet. Vision is improving at week 4, but paresthesia in hands still present.
31 2021-04-26 tremor Tiredness, chills, shaking, lightheadedness, reaction site pain (normal amount)
31 2021-04-27 seizure Patient received vaccine in clinic around 10:20am. Patient waited around the pharmacy for around 20... Read more
Patient received vaccine in clinic around 10:20am. Patient waited around the pharmacy for around 20 min and then left. Patient returned around 11-11:10 am with his mother in which we were notified that he was having a reaction. We brought the patient into the patient care room in which he was vomiting and patient's mother stated that he had a seizure. Patient was conscious but had some altered mental status. Patient denied any falls. 911 was called and EMS took patient to the hospital.
31 2021-04-28 flushing Syncope, flushing, sweating, vitals wnl. Repositioned, given water.
31 2021-04-28 pain in extremity, tingling Severe vasovagal episode with hyperventilation, shortness of breath, dizziness, nausea, headache, an... Read more
Severe vasovagal episode with hyperventilation, shortness of breath, dizziness, nausea, headache, and intense pain, tingling, and tetany in feet and hands. I was seen at the nearby emergency room where I underwent an EKG and monitoring until my vitals stabilized about an hour and a half later. Today, 4/29/2021, I am recovered from the severe symptoms and so far I just have a very sore arm, headache, chills, and fatigue.
31 2021-04-29 pain in extremity Patient presented to ED with complaint of left arm pain starting today (2 days post-vaccine). Axilla... Read more
Patient presented to ED with complaint of left arm pain starting today (2 days post-vaccine). Axillary pain, lymph node palpable. Dx axillary lymphadenopathy. Patient received ketorolac 30mg IM x1 and discharged home from ED.
31 2021-04-30 weakness, unresponsive to stimuli Patient received COVID-19 vaccination at pharmacy on 5/1/21. At the time of vaccination (11:24am), p... Read more
Patient received COVID-19 vaccination at pharmacy on 5/1/21. At the time of vaccination (11:24am), patient was feeling fine and reported no previous medical history of vaccination reactions, allergies to medications, foods, or vaccinations. After 4 minutes had passed, the patient was talking to his wife during his 15 minutes of observation when his eyes rolled behind his head and he became unconscious. Pharmacist rushed to patient?s aid. Pharmacist noticed his skin color was pale and she checked his pulse. The pulse was very weak and his O2 saturation was at 85. Pharmacist tried to wake him by asking his name and touching his shoulder. His wife was doing the same and patient remained unconscious. Pharmacist had another employee in the room call 911 while she administered 0.3 mg Epi Pen in left thigh. Patient finally came to and pharmacist lowered patient to the floor so that he was positioned lying down with his knees up. Heart rate was at 45, O2 saturation at 87, BP 128/90. Patient was able to state his name and know where he was but very weak. EMS arrived and checked vitals and blood sugar. EMS encouraged patient to go to hospital for further evaluation; however, patient refused to go to hospital and was educated to go to ER if symptoms returned. Patient was taken home by wife. A follow up call was made to patient at 3pm and wife stated patient was doing alright at home but very weak.
31 2021-04-30 cold sweat Runny Nose; Coughing; Cold Sweats; Pounding Headache; This is a spontaneous report from a contactabl... Read more
Runny Nose; Coughing; Cold Sweats; Pounding Headache; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in deltoid left on 07Apr2021 13:30 (Batch/Lot Number: EW0158) as single dose for COVID-19 immunization. The patient medical history included COVID 19 in December and had serious side effects. Patient denied any medications, medical conditions, labs, testing, or treatments. Stated he was the healthiest person. The patient's concomitant medications were none. No prior vaccinations (within 4 weeks). Patient took COVID 19 Shot because he wanted to stop wearing a mask and wanted to travel. The patient experienced pounding headache (reported as worsened) from 09Apr2021 with outcome of not recovered, cold sweats from 11Apr2021 with outcome of recovered on 11Apr2021, runny nose from 12Apr2021 with outcome of not recovered, coughing from 12Apr2021 with outcome of not recovered. AEs did not require a visit to Emergency Room and Physician Office. No family medical history relevant to AEs. No relevant tests. The patient underwent lab tests and procedures which included covid-19: positive on an unspecified date. Clinical course reported as follow: Patient stated the Friday after his vaccine he had a pounding headache. He had take off from work today due to his headache. Said it had eased off, but it came back today worse. Patient said he woke up with cold sweats on Sunday. Has not experienced this symptom since then. Runny nose and coughing started on Monday and was ongoing about the same as when it started. No follow-up attempts are needed. No further information is expected.
31 2021-05-01 feeling hot 7-8 Days after 2nd dose of COVID Vaccine, the skin on my fingers started to peel like they would aft... Read more
7-8 Days after 2nd dose of COVID Vaccine, the skin on my fingers started to peel like they would after a sunburn. There was no prior rash. I can only remember around 4 days after the vaccine, my fingers felt warm as if they had a sunburn, but I had no exposure to sun, UV, or any heat source that might explain the heat/peeling. This did not occur to my wife, who received the same vaccine at the exact same times from the exact same batch from the exact same CVS. The only side-effect she had was a swollen thumb on the hand belonging to the arm which received the vaccine. This last form day 2 till about day 6 after the 2nd dose. Did not occur during 1st dose, so we don't know if its related to the vaccine. Again, we found no other cause for the potential swollen Thumb.
31 2021-05-03 tingling Pain in left jaw, pins and needles in left side of face, headaches in left side of head
31 2021-05-04 discomfort, numbness, coordination abnormal, tingling, burning sensation Started with numbness and tingling throughout both legs and progressively worsening to severe full b... Read more
Started with numbness and tingling throughout both legs and progressively worsening to severe full body burning/buzzing pain. Also experienced dizziness and slight loss of muscle strength/coordination. Difficulty breathing.
31 2021-05-04 numbness Pt received first dose COVID 19 vaccine 3:07pm on left arm and left to pharmacy after 15 minutes obs... Read more
Pt received first dose COVID 19 vaccine 3:07pm on left arm and left to pharmacy after 15 minutes observation. Pt came back to vaccine site after pharmacy c/o weakness and numbness in left arm 3:40pm. BP 127/92 HR 77 O2 98 BS83, last meal at around 1pm. NP was on site to evaluate pt. Pt is A&O but lethargic. Pt was able to move his right arm, right leg, and left leg weakly but not able to move his left arm. Both arm appeared to be pale. Sensation intact for all extremities, no facial droop. Pt then c/o SOB. Called ambulance, wife left with pt to medical center.
31 2021-05-05 numbness, pain in extremity After about 20-30 minutes after receiving a shot in my left arm I began to feel a very minor allergi... Read more
After about 20-30 minutes after receiving a shot in my left arm I began to feel a very minor allergic reaction. The left side of my face, neck, and mouth became slightly numb, similar to how it feels after the anesthesia in your mouth begins to subside after an appointment to the doctor's office. This lasted for about 60 minutes. No other symptoms were present outside of my left arm being somewhat sore.
31 2021-05-05 pain in extremity Fever, chills, headache, sore arm, swollen arm, lethargy, sensitive and sore skin. These began withi... Read more
Fever, chills, headache, sore arm, swollen arm, lethargy, sensitive and sore skin. These began within 6 hours of the shot and were debilitating for 48 hours. Severe for 49-72 hours and then fever broke and other symptoms gradually subsided over next 48 hours. At some (unknown) time after the vaccine, I developed viral pericarditis. In addition to the above, this manifested in chest pain (no difficulty breathing) which radiated from what felt like the lungs, through my windpipe, into a sore throat, jaw muscles hurting, inner ear and neck soreness. These symptoms lasted after all had subsided and didn?t disappear until 14 days after the 2nd vaccine.
31 2021-05-05 tremor Extreme chills/shakes
31 2021-05-07 tremor, feeling cold 2000 Light sensitivity 2200 cold/shakes 2430 nausea 0300 vomiting, fever 102.3
31 2021-05-09 flushing 11:15 am while sitting at the observation area he complained that he was light-headed . Noted he was... Read more
11:15 am while sitting at the observation area he complained that he was light-headed . Noted he was warm-flushed and pale lips. Then later on he was sweaty. Vital sings taken. BP initially was 84/54 mmHg; HR=88 O2 sat=96% T= 97.8 . Instructed to lay down and gave him fluids. Denies any c/o N/V. 11:25 am BP 121/76 HR = 76. Still a little sweaty but feels much better . Less pale lips. 11:40 am Up and claims he is feeling much better. BP 113/72. No sweating noted. Color improved and requested to be discharged. 15:00 pm RN called him and stated that he went back to work and he was doing better.
31 2021-05-11 feeling hot Patient received vaccine and fainted. He was dizzy, felt hot, was groggy, and side of his neck hurt.... Read more
Patient received vaccine and fainted. He was dizzy, felt hot, was groggy, and side of his neck hurt. He had no previous reactions to any vaccines. We provided water, cool cloth, and called ambulance.
31 2021-05-11 tingling Admitted to hospital on 5/3 with difficulty breathing, chest pain, light-headedness/dizziness, tingl... Read more
Admitted to hospital on 5/3 with difficulty breathing, chest pain, light-headedness/dizziness, tingling in arms, and sloght loss of motor control of hands (clenching into fists uncontrollably). CT scan on 5/5 showed sub-sectional pulmonary emboli in both lungs. Released from hospital on 5/7 with treatment course including blood thinners.
31 2021-05-12 seizure Approximately 3-4 minutes after injection, patient stood up and said he didn't feel well. Felt dizz... Read more
Approximately 3-4 minutes after injection, patient stood up and said he didn't feel well. Felt dizzy, lightheaded. Took a step, fell to the floor. Did not hit head. Had a seizure while lying on the floor, lasting 1-2 minutes. Felt okay for a few minutes, then had another seizure lasting 1-2 minutes. 911 was called. Witness observed fixed pupils and sweating. Patient taken by ambulance to local hospital.
31 2021-05-13 seizure Pt received his vaccine and was being monitored. He mentioned he was feeling short of breath. He h... Read more
Pt received his vaccine and was being monitored. He mentioned he was feeling short of breath. He had an altered level of consciousness but did not pass out, but ammonia salts were used. He had his BP taken which was normal, Blood glucose was 70, pulse ox was 97% on room air. He appeared to have a seizure x 15 seconds. He has no hx of seizure activity. An onsite physician examined him and was supported by a PharmD and RN.
31 2021-05-13 tension headache, burning sensation, numbness, muscle twitching, tingling, weakness Woke up 2 days after vaccine and had tingling pins and needles throughout all my extremities. Massiv... Read more
Woke up 2 days after vaccine and had tingling pins and needles throughout all my extremities. Massive tension headache and pressure behind eyes and sinus that has lasted so far for 3 weeks, tinnitus, blurred vision, joint pain, muscle weakness, muscle twitching in face and throughout body, numbness in all my limbs, burning sensations on my neck and back, stomach pain, and heart palpitations that sent me to the ER. When I walk and move my arms I feel weak. The vaccine has effected my nervous system in a terrible way. The ER doctor, ENT, PCP, Optometrist, and Opthamologist told me it was inflammation due to the vaccine. I was prescribed 6 days prednisone, 40mg for 2 days then taper down and they put me in a "let's wait and see" mode. All symptoms have persisted since. I follow-up with a cardiologist on 05/14/2021 and waiting appt for a neuro ophthalmologist.
31 2021-05-14 muscle spasms I had fever and achiness the day after. Fever of 101 degrees. This was on top of an injection site r... Read more
I had fever and achiness the day after. Fever of 101 degrees. This was on top of an injection site reaction with pain. 36 hours after the shot I developed extremely swollen lymphnodes in my chest area, accompanied by soreness and pain. Along with this has been continuous (seemingly non-stop, as the issue has not been resolved) muscle spasms.
31 2021-05-14 tingling, numbness Numbness/parasthesia of the right scapula; Numbness/parasthesia of the right scapula; This is a spon... Read more
Numbness/parasthesia of the right scapula; Numbness/parasthesia of the right scapula; This is a spontaneous report from a contactable Physician (patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 12:00 (Batch/Lot Number: EK9231), age at vaccination of 31-years-old, as single dose, for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had not received other vaccine in four weeks. The patient experienced numbness/paraesthesia of the right scapula on 20Jan2021 01:30 PM. No treatment was administered. The patient underwent lab tests and procedures which included sars-cov-2 test negative on an unspecified date. The patient had not recovered from the events. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 12:00 (Batch/Lot Number: EL3247), as single dose, for covid-19 immunisation. Follow-up attempts completed. No further information expected.
31 2021-05-16 burning sensation Patient received vaccine Thursday morning. Later that evening, he started experiencing chills, fever... Read more
Patient received vaccine Thursday morning. Later that evening, he started experiencing chills, fever (>101F), and body aches for the next couple of days. Saturday morning, fever continued with body aches throughout the day but other symptoms subsided. Chest pain started Saturday evening but patient was unsure what it was. Saturday after midnight, patient went to sleep and woke up after 30 mins with chest pain, chest pressure, burning sensation in chest, and stiff neck. Patient couldn't lay down in bed and went to ED.
31 2021-05-16 tingling Patient is experiencing pins and needles on left side on his face, arms about an hour after vaccinat... Read more
Patient is experiencing pins and needles on left side on his face, arms about an hour after vaccination about 50 minutes after vaccination. Patient has sit for the allocated 15 minutes for observation but did not report any side effects. Patient came back to the pharmacy to report pins and needles on left side of his face and arms. Patient is able to breath normally and did not experience any other side effects or reactions. Patient was advised to apply ice pack and to observe for other side effects especially if there is difficulty breathing and if needed we could call the ambulance for him. Patient declined ambulance but will observe for worsening side effects. Patient's provider was also called and as per MD, patient will just have to be observe and to make necessary appointment or ER if symptoms persist. I've spoke with patient at 1:45 pm and patient stated that pins and needles have slightly diminished.
31 2021-05-18 weakness Body aches, weakness, fatigue, nausea, vomiting with quick onset around 10:30 pm on 5/18. Called phy... Read more
Body aches, weakness, fatigue, nausea, vomiting with quick onset around 10:30 pm on 5/18. Called physician and employer health line for symptom check-in. Recommended ED visit or OTC medication at home. Chills began around 11:45 pm on 5/18. Took two Advil for a total of 500mg Acetaminophen and 250mg Ibuprofen at 12:00 am on 5/19.
31 2021-05-18 flushing Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild... Read more
Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: vision was obstructed for a little. took off mask to get some breaths in and felt better. blood pressure was a little low. water given. followed up a few hours later. pt felt fine.
31 2021-05-18 seizure PATIENT REPORTED A SEISURE INCIDENT AFTER RECEIVING PFIZER COVID VACCINE
31 2021-05-18 tremor Pfizer-BioNTech COVID-19 I got the 2nd shot around 3pm and felt fine throughout the rest of the day.... Read more
Pfizer-BioNTech COVID-19 I got the 2nd shot around 3pm and felt fine throughout the rest of the day. Around 10pm when I started feeling feverish. Around 11pm, while laying in bed, it started getting much worse - shaking uncontrollably, feeling nauseous, very dizzy, fever - flu like symptoms which seemed normal for the vaccine, but then they got much worse and very strong. I couldn't fall asleep and at 1am I got out of bed to get tylenol. I took the tylenol and was still feeling naeusous so went to the bathroom. I don't remember what happened next because I fainted and woke up on the floor. I hit my head in the fall and head to get 4 staples and had a laceration above my eye. I think I may have fainted again shortly after that but don't remember because I was out of it. I went to the ER - all tests came back normal at that point. I had covid about 2 months before the vaccine. I had no side effects from the first shot.
31 2021-05-20 cold sweat Fever, Chills, Headache, Severe Muscle Ache, Sore Throat, Cold Sweats, Hallucinations for 8 days.
31 2021-05-21 bell's palsy Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male... Read more
Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729) via an unspecified route of administration, in arm left, on 07Apr2021 09:30 AM (at the age of 31-year-old), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: EP6955), in arm left, on 17Mar2021 09:30 AM (at the age of 31-year-old), at single dose, for COVID-19 immunization. The patient experienced bell's palsy on 12May2021 23:00. AE result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Patient received valacyclovir and prednisone as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient did not receive any other vaccines within 4 weeks. Since the vaccination, the patient hadn't been tested for COVID-19. Case was reported as non-serious by reporter. The outcome of the event was unknown.
31 2021-05-23 pain in extremity Fever; chills; arm pain.
31 2021-05-25 weakness, tremor Inflammation; Chills; Sweats; Fever; Shaking; could not sleep very well and was going in and out of ... Read more
Inflammation; Chills; Sweats; Fever; Shaking; could not sleep very well and was going in and out of sleep; Dizziness; Unable to eat; Weakness; Shortness of breath; Excruciating hemorrhoid pain; Left arm was really stiff; Left arm gets locked up; This is spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 03May2021 (Lot Number: EW0179) as 2nd dose, single at the age of 31-years-old for covid-19 immunization. Medical history was none. Family medical history included: High blood pressure, diabetes, high cholesterol and heart problems. The patient's concomitant medications were not reported. The patient received 1st dose of bnt162b2 on 12Apr2021 with Lot ER8729, expiration is unknown, injected intramuscularly in left arm. No additional vaccines administered on same date of the pfizer suspect. No AE following prior vaccinations. No other prior vaccinations (within 4 weeks). The patient received the 2nd dose of the bnt162b2, and the next day (04May2021 12:00) the patient had excruciating slowly pain like a hemorrhoid pain. The patient bought hemorrhoid cream. The patient experienced shortness of breath on 05May2021, when he woke up yesterday he had it as well. He could not sleep very well and was going in and out of sleep. He could not sleep because of discomfort for hemorrhoid pain. The patient also had dizziness on 06May2021 12:00, inflammation, chills, sweats, and fever. He said that his left arm (injection site) gets locked up on 03May2021 23:00. He also said that he experienced shaking, weakness and was unable to eat on 05May2021 11:00. When he woke up on 04May2021, his left arm was really stiff. Yesterday, he was not able to eat (worsened). His weight was provided as being between 180-190 lbs. There was no prescriber. NO ER or physician's office required. Outcome for hemorrhoids was provided as both persistent and worsened, of the events shortness of breath, dizziness, weakness, left arm gets locked up was not recovered, of other events was unknown. No follow-up attempts are needed. No further information is expected.
31 2021-05-25 pain in extremity, burning sensation, muscle twitching pressure headache; tinnitus; hyperacusis; grainy and double vision; photophobia; facial twitching; P... Read more
pressure headache; tinnitus; hyperacusis; grainy and double vision; photophobia; facial twitching; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Burning sensations in back and arms; Muscle weakness in legs and arms; Large rash at injection site; Swollen lymph nodes in both arms; This is a spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: ER8736, Expiration date: not reported) via an unspecified route of administration in left arm on 23Apr2021 at 10:00 AM (at the age of 31 years) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included diabetes (controlled) and concomitant medications were not reported. The patient had a history of allergies to Demerol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955, Expiration date: not reported) via an unspecified route of administration in left arm on 31Mar2021 at 12:00 PM as 1ST DOSE, SINGLE for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was reported as Vitamin C, D3. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021 at 07:45 AM, the patient stated that he woke up with pressure headache, tinnitus, hyperacusis, grainy and double vision, photophobia, facial twitching, pain in back, shoulders and arms, burning sensations in back and arms, muscle weakness in legs and arms, large rash at injection site, swollen lymph nodes in both arms. The adverse events resulted in the doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received for the adverse events which includes Prednisone. The events were reported as non serious. Outcome of the events were reported as Not recovered.
31 2021-05-25 tingling, numbness Upon receiving the second dose of the COVID-19 vaccine, I immediately felt tingling or chills in the... Read more
Upon receiving the second dose of the COVID-19 vaccine, I immediately felt tingling or chills in the arm where the shot was administered. This developed into muscle soreness as I sat through the waiting period before leaving the facility. (For this reason, I had taken acetaminophen at about 8:30 that morning.) I experienced both of these symptoms after my first shot of this COVID-19 vaccine, so these did not concern me. After taking a nap back at my house, I woke up about 3:30 p.m. experiencing some partial numbness in my left arm, which received the injection. It was not inhibitive, but I can somewhat relate it to the neuropathy my mother experienced before being diagnosed with diabetes in 2005. It was a bit like the tingling I first experienced after the injection, but throughout the injected arm. As I continued through that afternoon and evening, my arm kept getting stiffer and stiffer. This prompted me to take my temperature at about 8 p.m. and then again at 10 p.m. Both of these tests resulted in a normal temperature of 98.3 or 98.4 degrees. By the time I was about to climb into bed at midnight, the stiffness had spread to my shoulder joint -- such that almost any movement of that arm elicited some mild discomfort, especially if I leaned against the wall with that shoulder or raised my arm above my head. I took a third dose of acetaminophen. My normal prone sleeping position was not comfortable with this stiffness, so I did my best to sleep on my back. Next, I woke up too hot about 3:30 a.m. (Wednesday, May 26) and could not get back to sleep. Full-body chills set in soon after, prompting me to turn off my ceiling fan. I faced some mild nausea as I attempted to get comfortable in bed again. I suspected I was feverish by at least 4 a.m., but I did not get up to check my temperature until 5 a.m. The thermometer gave a reading of 100.3 degrees, so I took another dose of acetaminophen (my fourth in 24 hours) and tried to go back to sleep.
31 2021-05-25 tremor achy joints; mild sore throat; nausea; Fever; chills; shaking; Headache; This is a spontaneous repor... Read more
achy joints; mild sore throat; nausea; Fever; chills; shaking; Headache; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 18Feb2021 11:45 (Batch/Lot Number: EL3247) as age at vaccination of 31-years-old, as single dose, for covid-19 immunisation. Medical history was none; the patient had no allergy. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 03:00 PM (Batch/Lot Number: EL3247) for covid-19 immunisation. There were no concomitant medications. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. Starting at 2 AM on 19Feb2021, the patient experienced achy joints then fever, chills, shaking, headache, nausea and mild sore throat were all experienced. Therapeutic measures were taken as a result of the events and included administration of ibuprofen. The patient had not covid prior vaccination and was not covid tested post vaccination. The patient was recovering from the events. Follow-up attempts completed. No further information expected.
31 2021-05-27 numbness Numbness on one side of face for 3-4 days 2 days after receiving vaccination.
31 2021-05-28 hot flush Severe headache; Hot flashes; Chills; Loss of appetite; Fatigue & exhaustion; Dulled sense of smell ... Read more
Severe headache; Hot flashes; Chills; Loss of appetite; Fatigue & exhaustion; Dulled sense of smell and taste; dulled sense of smell and taste; This is a spontaneous report from a non-contactable other hcp. A 31-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 24Feb2021 (Batch/Lot Number: EL3247) as 2ND DOSE, SINGLE for covid-19 immunisation. The medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. On 25Feb2021 05:00, the patient experienced severe headache, hot flashes, chills, loss of appetite, fatigue & exhaustion, dulled sense of smell and taste, and with onset 15 hours after shot administered adverse effects duration 48 hours; dulled sense of smell and taste still on-going dulled sense of smell and taste. The outcome of the events was reported as recovering. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
31 2021-05-29 slurring, face paralysis, speech disorder Immediate onset of L facial weakness/inability to fully close lips on L side (contract muscles) to s... Read more
Immediate onset of L facial weakness/inability to fully close lips on L side (contract muscles) to seal lips when eating/drinking. Evaluated in ER and stroke ruled out by negative head CT and workup. Misdiagnosed as Bell's palsy, no treatment, told it could take several weeks or months to resolve and to wait it out. Upper lip tight and smile changed. Symptoms persisted and slowly worsened/progressed, overall muscle strength diminished, some bronchospasm issues with heavy exercise. Seen by PCP and allergy doctor and told likely has exercise-induced asthma and still resolving Bell's palsy. Facial symptoms continued to worsen and began involving his palate, unable to close off sinus passage way, slurred and nasal speech in the evenings, unable to chew and swallow well towards evening. Patient feared he had ALS after researching symptoms, I started to worry it was myasthenia gravis. Saw PCP again who refused to order confirmatory lab work for MG or ALS and referred to neurology. Referral turnaround was not emergent despite several calls and attempts to escalate this issue. Unable to verbally communicate in the evenings, resorted to texting to express needs. Had a scary episode of choking due to inability to swallow, 911 called to home. Sent to ER for workup and finally a neuromuscular disorder was on the differential. Transferred to a higher level of care for on-site neurology where he received IVIG x 5 days and started pyridostigmine for likely myasthenia gravis with rapid improvement in symtoms. Plan is for continued monthly IVIG and then adding an immunosuppressant long-term in addition to his pyridostigmine.
31 2021-05-29 pain in extremity Patient had pain shooting from back to leg. He was unable to walk or work for two days. He had high ... Read more
Patient had pain shooting from back to leg. He was unable to walk or work for two days. He had high fever of 102. Pain was said to be an 9/10.
31 2021-05-29 tingling Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Wrong Route (SC, IM, etc.), Add... Read more
Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Wrong Route (SC, IM, etc.), Additional Details: tingling of arm down to fingers
31 2021-06-03 tingling Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Sy... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
31 2021-06-05 numbness, muscle spasms a) Rapid heart beat (up to 140/min.) immediately after vaccination. Heart rate normalized after half... Read more
a) Rapid heart beat (up to 140/min.) immediately after vaccination. Heart rate normalized after half hour of rest. b) Acid reflux three days after vaccination. Took Omeprozole & Sucralfate tabs and recovered within 3 weeks. c). Tachycardia & palpitation occurred on 4/12/2021. Hard to fall asleep at night. Visited ER, no treatment (blood test, chest X-ray and EKG all normal). d). Excessive fatigue following just a few steps of walk, or speaking just a brief moment. Began to be sensitive to screen light and sound from loudspeakers. e). Hospitalized on 4/16/2021, b/c of breathing problem, numbness (hands & feet) and muscle cramps. Called 911 for ambulance to hospital. Discharged on 4/18/2021 after testing normal for chest X-ray, EKG, echocardiogram. Prescribed Bisoprolol Fumarate tabs. f). After discharge from hospital, I had to remain on bed b/c of breathing difficulty upon standing up or slight movement. Excessive sweat during sleep or after meals. g). Subsequently I felt a little better and began to do minor exercises (walking in the yard) May 14-19. While lying on the bed on the night of May 19, I felt short of breath and worsening of breathing patterns (i.e. shallow breathing). h) On May 23, I began to feel shortness of breath when I walk or after a meal. i) Staring May 24th, I felt very weak breathing when lying on bed. Since then, I have experienced weaker & weaker tidal volume. j) Staring May 27th, I felt shallow breathing when I was at rest during the day. Since then, I have experienced weaker & weaker tidal volume.
31 2021-06-05 unresponsive to stimuli About two minutes after receiving the vaccine, the patient was talking to me then suddenly stopped t... Read more
About two minutes after receiving the vaccine, the patient was talking to me then suddenly stopped talking and slumped over. He was able to speak to us after about 30 seconds and drink water.
31 2021-06-06 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: patient had not eaten anything all day
31 2021-06-09 cold sweat, numbness Injection site swollen around my back arm and armpit, small hive left inner elbow, increased heart r... Read more
Injection site swollen around my back arm and armpit, small hive left inner elbow, increased heart rate, blood pressure was 183/110. Was hard to breathe, clammy, faint, confused, and panicky. Left arm went numb. I went to hospital twice, and clinic twice due to the symptoms coming and going.
31 2021-06-09 pain in extremity throat itchy and scratchy; hard to breathe; fever; fatigue; arm pain; This is a spontaneous report f... Read more
throat itchy and scratchy; hard to breathe; fever; fatigue; arm pain; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: unknown), via an unspecified route of administration in the right arm on 16Mar2021 at 12:00 pm (at the age of 31 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. 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 17Mar2021 at 1:15pm the patient developed itchy throat and scratchy, found hard to breathe (difficulty breathing), fever, fatigue and arm pain. The patient did not receive treatment for the events. The clinical outcome of itchy throat, difficulty breathing, fever, fatigue and arm pain was not resolved. Information about lot/batch number cannot be obtained. No further information is expected.
31 2021-06-10 inability to speak, nerve pain, migraine Dose 1 - I had increased body wide nerve pain. At that time, they thought I had fibromyalgia and the... Read more
Dose 1 - I had increased body wide nerve pain. At that time, they thought I had fibromyalgia and the shot caused a flare up. Dose 2 - I had very severe body wide nerve pain, vertigo, terrible migraines, vision issues, confusion, short term memory loss and grasping for words and increased muscle weakness. It kind of mirrored a stroke. The pain was a 10/10. It was basically like all of my symptoms were getting progressively worse over the weeks. It's gotten better, but the symptoms are definitely still there. My neurologist increased the dosage of a few of my meds. At this time, they're basically managing my symptoms, but we do not have a definite source for the issue. However, the vaccine definitely caused the flare up because nothing else in my life has changed.
31 2021-06-10 numbness Whole left side of face is numb. No feeling in lips, ears, jaw line, cheek area on left side.
31 2021-06-13 tingling On 6/11/2021 after my 2nd injection, I received muscular pains in my left arm. After applying pressu... Read more
On 6/11/2021 after my 2nd injection, I received muscular pains in my left arm. After applying pressure to it, it felt much worse. On 6/13 I went to a walk-in clinic to have it checked out. The NP prescribed 7 days of Naproxen 500mg and to use hot/cold treatment as needed. At the time of this form being filled out, I have a tingling sensation in my left hand and forearm, due to the Naproxen after doing research. The condition has not worsened.
31 2021-06-15 weakness, numbness, sensory loss Shortly after receiving my second dose of the Pfizer vaccine on 30 Mar 2021, there was insidious and... Read more
Shortly after receiving my second dose of the Pfizer vaccine on 30 Mar 2021, there was insidious and unilateral onset of pain of the left shoulder that quickly amplified in severity and intensity. This pain was subsequently replaced over the ensuing days and weeks with progressive weakness, reflex changes, and sensory abnormalities in shoulder girdle musculature and proximal upper limb. The progressive neurologic deficits of motor weakness, dysesthesias, and numbness have persisted. Subsequent tests (MRIs and EMGs) have been ordered to confirm and/or rule out possible causes of the event.
31 2021-06-15 migraine Nausea, headache, migraine. Extreme pain and swelling of lymph nodes. Lymph nodes under the armpits ... Read more
Nausea, headache, migraine. Extreme pain and swelling of lymph nodes. Lymph nodes under the armpits swelling with extreme pain. Swelling of lymph nodes was greater and more painful near site of injection.
31 2021-06-16 numbness This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EW0167, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 12May2021 at 08:30 (at the age of 31 years old) as first dose, single for COVID-19 immunisation in a hospital. Medical history included overactive bladder from an unknown date and unknown if ongoing. The patient has known allergies with beeswax. Prior to vaccine the patient was not diagnosed with COVID-19. Concomitant medications included tolterodine, xantofyl (LUTEIN), fish oil and vitamin d, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. When the patient got his shot of BNT162B2, the patient felt no pain when the nurse administered the shot. On 12May2021 at 21:00, the patient started to feel numbness occasionally in the thenar muscle on the radial side of the patient's left hand. The numbness was most obvious during complex hand movements such as hand washing and but it wasn't persistent. It was further described that it felt like the sudden numbness the patient gets when he accidentally hit his elbow against the wall but less intense. The patient woke up the next day with persistent numbness in his entire left hand, affecting the wrist, palm, and all 5 fingers. This persistent numbness the patient had felt was like the numbness he gets when he was sleeping on his side with his hands under his head. It extended to the patient's distal forearm on 15May2021. At the day of the report ,the 5th day after vaccination (as reported), the soreness of the injection site had subsided but both types of numbness in the patient's left hand remained. They're were not as bad as "pins and needles" and there was no tingling sensation but it was concerning the patient. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was not recovered.
31 2021-06-20 tingling After administration of the pfizer covid vaccine, patient experienced dizziness, chest tightness, ti... Read more
After administration of the pfizer covid vaccine, patient experienced dizziness, chest tightness, tingling in the hands and had sweaty palms. Patient reported that possible dehydration may have contributed to dizziness and was given water and monitored for 1 hour.
31 2021-06-21 depressed level of consciousness Woke that morning very lethargic and hard to arouse. Mom states had been doing very well, exercisin... Read more
Woke that morning very lethargic and hard to arouse. Mom states had been doing very well, exercising and losing weight. States he felt good up until that day. DEATH
31 2021-06-22 numbness Patient experienced chest pain and arm numbness 11 days after receiving vaccine on 6/22/21. He went ... Read more
Patient experienced chest pain and arm numbness 11 days after receiving vaccine on 6/22/21. He went to ER and a chest CT images revealed a pulmonary embolism. He was discharged on 6/22/21 with a prescription for Eliquis 5mg BID.
31 2021-06-22 numbness I had numbness in my right hand consistently about two hours after the shot (noticed when putting so... Read more
I had numbness in my right hand consistently about two hours after the shot (noticed when putting son down for bed). Figured it would go away by morning. The next morning, the numbing had left my right hand but moved mainly to my fingers and toes and was no longer constant but sporadic. Every few minutes a toe would become numb or a finger (sometimes a side of my leg or arm but usually a digit). It has lasted for a week now. Not painful but annoying. I am not getting the second dose given this side effect for a "safe" shot and the unknown consequence of getting what often results in worse side effects for the second shot. I feel the response from CVS and my doctor has been poor and leaves me with significant doubt on our medical system and vaccination program.
31 2021-06-23 feeling hot Client received the COVID vaccine (Pfizer dose 1, lot # EW0187, expiration date 7/12/2021) in his l... Read more
Client received the COVID vaccine (Pfizer dose 1, lot # EW0187, expiration date 7/12/2021) in his left deltoid at 1835. The client reported to RN at 1705 that he was experiencing itching. RN informed EMT and RN , who responded at that time. The client stated that the itching had started "5 minutes" after he was vaccinated and he was experiencing itching on his bilateral upper and lower extremities, as well as the back of his head. The client denied any shortness of breath or chest pain. The client didn't have any observable swelling on his head or tongue, and he had no observable rashes on his extremities or head. The client stated he had a history of hypertension but takes no medications, and he stated that he had an allergy to penicillin. The client stated that he last ate at noon. At 1710, the client's vital signs were as follows: blood pressure 158/112, heart rate 76, respiratory rate 18, O2 97%. The client stated he did not know his usual blood pressure range. The client denied any headache and his pulses were normal. The client stated that he was feeling "heat"; the client's skin was pink, warm, and dry. The client continued to denied any difficulty breathing. The client was alert and oriented x4. The client was offered water and oral Benadryl (50 mg) at 1710, which he accepted. At 1720, the client's vital signs were as follows: blood pressure 152/102, heart rate 74, O2 96%. The client stated that the itching had stayed the same. Education provided to the client and his partner regarding emergency management, primary care follow up, and v-safe. At 1730, the client's vital signs were as follows: blood pressure 150/96, heart rate 78, O2 95%. At 1735, the client stated that his symptoms of itching and heat had resolved. The client was sitting in his chair comfortably resting. At 1740, the client was able to stand without dizziness, and ambulated with a steady gait out to his car, where his partner drove him home.
31 2021-06-28 pain in extremity The patient is a 31 year old kidney transplant recipient who had been in his usual state of health a... Read more
The patient is a 31 year old kidney transplant recipient who had been in his usual state of health and feeling well over the past months. On May 7, he received the first dose of COVID vaccine and experienced intense myalgias at that time. He recovered, but then around May 17 noted the onset of pain in the R thigh and lower R back and subsequently developed a vesicular rash in this area. He saw his primary care physician who prescribed gabapentin. However his pain worsened and the rash extended and he presented for admission. He was diagnosed with disseminated zoster, was hospitalized from 5/24/21 - 5/29/21 and was treated with IV acyclovir followed by oral valacyclovir.
31 2021-06-29 pain in extremity Sore and tight in left arm; This is a spontaneous report from a contactable consumer, the patient. A... Read more
Sore and tight in left arm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old adult male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: UNKNLOWN), via an unspecified route of administration in the left arm on 07Mar2021 at 14:45 (at the age of 31 years old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included fluticasone(ARNUITY ELLIPTA) for unknown indication from unknown date. The patient did not have known allergies to medications, food, or other products. 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 09Mar2021, the patient experienced sore and tight in left arm (where injection was received) on the underneath side of the arm, spanning from bottom of armpit to elbow. No heat or swelling, just a dull and uncomfortable sensation. The patient underwent lab tests and procedures, which included COVID-19 Virus test on unknown date and resulted negative. 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 treatment for the reported event. The clinical outcome of pain in arm was recovering. Information about lot number cannot be obtained. No further information is expected.
31 2021-07-01 hot flush, pain in extremity heat flashes that feel like a fever; Arm pain; off and on headaches; This is a spontaneous report re... Read more
heat flashes that feel like a fever; Arm pain; off and on headaches; This is a spontaneous report received from a contactable pharmacist. A 31-year-old, male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955), via intramuscular route administration in left arm on 23Mar2021 at 1500 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history included migraines. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. The Patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, the patient experienced arm pain, off and on headaches and intermittent heat flashes that felt like a fever. No therapeutic measures were not taken for the 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 arm pain, headache and hot flashes was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
31 2021-07-02 weakness 4/7 - First dosage. Following day experienced lack of energy, lethargic - as is typically reported. ... Read more
4/7 - First dosage. Following day experienced lack of energy, lethargic - as is typically reported. Initial symptoms resolved after 24 hours or so. 4/16 - started experiencing cold/cough symptoms. Symptoms persisted as minor cough until second dosage on 4/29 4/29 - received second dose 5/3 - started having trouble breathing. Pulse-Ox around 93/94. Went to urgent care. No findings reported from X-ray. Given subscription for coriciden and left. 5/3 - 5/22 - coughing And trouble breathing persist. Manage symptoms at night typically with NyQuil 5/24 - the preceding few days mucus had been getting darker and darker leading me to believe I had an infection. Did a telehealth visit with Dr where she prescribed z-pack. 5/24 - 5/29 - Course cleared up dark mucus but cough remained. 5/29 - 6/30 - cough throughout. Symptoms worsen at night. Overproduction of mucus in airway. Feels constrained. 6/30 - met with Dr Money. Took blood sample and ordered CT scan.
31 2021-07-02 bell's palsy Bell?s Palsy on the right face
31 2021-07-02 discomfort After my Second Shot I felt fine that day but the next day around 7am in the morning I feel sharp p... Read more
After my Second Shot I felt fine that day but the next day around 7am in the morning I feel sharp pain in my heart area and dizzy also shortness of breath and can?t get comfortable to sleep without pain since on that side also been experiencing headaches tomorrow will be third day since second dose of Pfizer
31 2021-07-06 discomfort, numbness uncomfortable; Extreme pain; Couldn't taste cheetos; Pulp in his arm; Worst fever he can imagine; Ch... Read more
uncomfortable; Extreme pain; Couldn't taste cheetos; Pulp in his arm; Worst fever he can imagine; Chills all over; Brain stating out/ his brain goes fuzzy; gutting his stomach; ribs were sore; Almost died; He thought his body went into shock; Numbness; This is a spontaneous report received from a contactable consumer or other non hcp. A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0178) via an unspecified route of administration in Arm Right on 19Jun2021 15:00 as single dose for covid-19 immunisation. Medical history included ongoing substance use. Concomitant medication(s) included hydrocodone and unspecified antibiotics taken for an unspecified indication, start and stop date were not reported. The patient received first dose of BNT162B2 (Batch/lot number: EN5318) via an unspecified route of administration in Arm Right on 20May2021 as single dose for covid-19 immunisation. The patient experienced worst fever he can imagine, pulp in his arm, chills all over on 19Jun2021, extreme pain on 20Jun2021, couldn't taste cheetos on 22Jun2021, numbness, he thought his body went into shock, almost died, brain stating out/ his brain goes fuzzy, gutting his stomach, ribs were sore on Jun2021. Caller reported as he got the second Covid Vaccine in his arm. He literally almost died. He went to (withheld), and they said it is normal and he should take some Tylenol. If he can die it is not normal. The hospital didn't want to do anything because they were afraid people would use him as a scapegoat and say if he is incapacitated, they will never take it. He had a bad dose or just had a severe adverse reaction. He had his vaccination card on him. It didn't happen until he had his second dose. He had been shot in the face with a 357 Magnum at point blank range, and this is more painful than that. It is legit more painful. He has never felt worse pain in his entire life. His card says Pfizer Vaccine EW0178. Maybe he got a bad dose. Right now, he has to be careful to not sit in one position because he was very uncomfortable. Further reporter stated briefly extreme pain: They gave him the shot and he went to sleep, and his body was immediately super tender and painful. He thought his body went into shock. He was shot in the face by a 357 Magnum so he knows the feeling. It started at 0000. In the morning he woke up and tried to eat food and couldn't taste Cheetos. He tried to go to the bathroom and peed on his leg twice, he was that kind of numb. The real pain came from trying to just exist. He was so tender that breathing was an obstacle and touching a pillow against his skin felt like getting hit by a bus for the next couple days. He still doesn't feel all that great. He needs antibiotics and a painkiller. He was smoking marijuana because everyone left him in the cold. Pulp in his arm: He could feel like a pulp in his arm where it was worse. It felt like a bullet was put into his arm. It was all pulpy and feels nasty. It was dispersants of coagulation and blood or the medicine and blood or something else. Either way it is gross. He put his hand against it and massaged it and it hurt like hell. The pain subsided. It was like he has PTSD. He had to get that out of his arm. When he gets the pulpy stuff out of his arm the dispersing pain was less and less, but it was still super painful. That was how he woke up initially. It was there only slightly now. Brain stat icing out: He also keeps having his brain static-ing out which was not a good thing. His brain goes fuzzy. He has had no medical tests. The clinical outcome of the events Numbness, worst fever he can imagine, pulp in his arm, brain stating out/ his brain goes fuzzy was recovering and other were not recovered. Information on Lot/Batch number was available. Additional information has been requested.
31 2021-07-06 tingling, numbness, migraine, numbness and pain in extremities Pressure, tingling, and numbness in his head and it spread to his arm and leg.; Pressure, tingling, ... Read more
Pressure, tingling, and numbness in his head and it spread to his arm and leg.; Pressure, tingling, and numbness in his head and it spread to his arm and leg.; Pressure, tingling, and numbness in his head and it spread to his arm and leg.; he was diagnosed with peripheral neuropathy; Pressure, tingling, and numbness in his head and it spread to his arm and leg.; Migraines; Insomnia; Fatigue; This is a spontaneous report from a contactable other health care professional reported via Pfizer sponsored program . A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 13May2021 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 31-year-old) for covid-19 immunisation. Medical history included none. There were no concomitant medications. No Family Medical History Relevant to AE. Prior to vaccination, the patient did not receive other medication within 4weeks. No AE reported following prior vaccination. On 13May2021, Patient started to experience fatigue and that was a normal side effect at approximately 10 am. The tingling and numbness she did not had exact time. While on 19May2021, patient started to have pressure, tingling, and numbness in his head, and it spread to his arm and leg. On unspecified date patient experienced Insomnia and migraines and he went to the doctor for tests to see what was wrong. Everything came back normal. The patient was hospitalized for two nights for the events pressure, tingling, and numbness in his head, and it spread to his arm and leg. Patient visited Emergency Room and Physician Office for the numbness, tingling and head pressure. Therapeutic measures were taken which included, patient has been given ibuprofen. That was what they typically give. It has been diagnosed as a migraine, for tingling given Gabapentin for he was diagnosed with peripheral neuropathy. For Numbness included Pretty much ibuprofen and gabapentin, it's all in one. Fatigue treatment included Gabapentin, they said gabapentin helps and makes sleepy and they increased it today and night because he was having insomnia as well. He was also taking magnesium and vitamin c. The patient underwent lab tests and procedures which included blood magnesium: low, blood test: normal, blood testosterone: low, thyroid function test: normal, vitamin c: low, vitamin d: low on an unknown date. Patient received his normal blood work. His thyroid and other normal labs. No investigation assessment was provided. The outcome for the event Pressure was ongoing it has been off and on recovering, Tingling, and numbness in his head and it spread to his arm and leg was not recovered while Fatigue was recovering, and rest of events outcome was unknown. His second was scheduled for 03Jun2021 and primary care assistant told him not to get the second shot, he only got one dose. Information on the lot/batch, further information has been requested.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 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.
31 2021-07-08 pain in extremity Arm pain, self-limiting
31 2021-07-08 seizure Patient had waited the recommended 15 min post shot. Went home and his aunt told us that his eyes be... Read more
Patient had waited the recommended 15 min post shot. Went home and his aunt told us that his eyes became blood shot, his throat started to close. He then proceeded to have 4 seizures. First one being at home, second in the car on the way to the ER, third once they arrived at the ER and fourth on the way inside into the hospital. Patients aunt called us 7/9 to give us the full details of the event. Patient spent the night in the hospital and is in stable condition.
31 2021-07-11 cold sweat Pt received his Covid vaccine and as was scheduling his second dose, pt stated he started to feel di... Read more
Pt received his Covid vaccine and as was scheduling his second dose, pt stated he started to feel dizzy. patient was reclined and gavin juice and called for assistance from the LVN . Pt was pale, clammy/sweaty, and dry heaving.; call for Rapid Response. They were in the pt's room within the minute and proceeded to take vitals and treated the pt with a bag of IV fluid while having the pt be observed by an RN for an additional amount of time. After the nurse observed the pt walking on his own, she gave pt permission to leave. Patient was discharged 1601 after receiving a liter of NS IV.
31 2021-07-11 numbness patient came in today 07/12/21 and mentioned since he got the vaccine on 06/21/21 he has been feelin... Read more
patient came in today 07/12/21 and mentioned since he got the vaccine on 06/21/21 he has been feeling side effects , he mentioned his hear beat feels different , numbing , some chest pain, dizziness , I mentioned to the patient to schedule a visit to his doctor , in order to do more tests , and make sure everything is ok, patient he will reach out to the Dr today
31 2021-07-11 tingling, coordination abnormal Developed severe vision impairment, tingling sensation in extremities, loss of balance/ coordination... Read more
Developed severe vision impairment, tingling sensation in extremities, loss of balance/ coordination, alterations in depth perception, reflexes become unresponsive upon physical exam at doc office & developed severe headache. Was unable to work or function normally for over 2 months being unable to work and needing additional help to care for my dependents. Was diagnosed with GBS by the hosapital.
31 2021-07-19 electric shock sensation, tingling severe cervicle neck pain for 3 weeks including radiculapathy severe headache inter cranial pressur... Read more
severe cervicle neck pain for 3 weeks including radiculapathy severe headache inter cranial pressure for 2 weeks non stop pressure in head and different parts of the brain due to elevation swollen lymph nodes left side of face correlates to vax in left arm swollen face and neck fluid filled ears and pressure & mastoid bone pressure neasua due to constant feeling of unsteadiness dizziness & vertigo for 7 weeks tingling in each section of brain electrical shock sensations weakness in arms legs hands severe fatigue and malaise lingering severe brain fog peripheral vision blurriness constant tunnel vision spine pain to middle spine after neck pain stopped chest bone pain and tightness heart pressure and pain random joint pain weakness tingling in hands and legs and head stomach discomfort diarrhea for 6 weeks and soft stool ringing in ears occasionally arachnoid cyst found where grinding & neck pain originated radiating into back of head and severe headaches to entire brain or different sections at random
31 2021-07-20 migraine Migrane for 5 days, 6th day sensitivity to light. I am not sure if it is relevant, but at the end... Read more
Migrane for 5 days, 6th day sensitivity to light. I am not sure if it is relevant, but at the end of about the month I had a cranial palsy in the left eye that could be unexplained but the eye specialist that suggested to do this. I am still experiencing it.
31 2021-07-22 pain in extremity, numbness Slight temporary numbness in left arm; Odd feeling in pit of stomach; Palpitations while attempting ... Read more
Slight temporary numbness in left arm; Odd feeling in pit of stomach; Palpitations while attempting to sleep; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male 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 03Apr2021 at 17:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included glucose-6-phosphate dehydrogenase (G6PD) deficiency. The patient had an allergy to legumes. Concomitant medications included melatonin (MANUFACTURER UNKNOWN), theanine (L-THEANINE), magnesium (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (MANUFACTURER UNKNOWN) all from an unknown date for unknown indication. The patient previously took aspirin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. 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 03Apr2021 at 18:00, the patient experienced a sore left arm where the vaccine was administered and slight temporary numbness in the left arm. The patient had an odd feeling in the pit of the stomach and had palpitations while attempting to sleep. 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 patient did not receive any treatment for the events. The clinical outcome of the events sore left arm, slight temporary numbness in left arm, odd feeling in pit of stomach and palpitations while attempting to sleep were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
31 2021-07-25 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for about 1 minute, urin... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for about 1 minute, urinated during fainiting. Paramedics checked patient vitals, everything was norma-blood pressure, heart rate. Pt has history of fainting in the past. Followed up with pt at 6 pm 7/25/21, pt is doing well with some headache. Before vaccination pt did not eat and he exercised. Pt received Pfizer Covid vaccine at 12;15 pm. Pt also said that he felt dehydrated, he only consumed caffeine in the morning.
31 2021-07-27 flushing Back of hands, elbows, thighs, knees have been itchy; Flushed; Regular rash. Knuckles, elbows, knees... Read more
Back of hands, elbows, thighs, knees have been itchy; Flushed; Regular rash. Knuckles, elbows, knees flushed in red and warm.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm left on 21Apr2021(at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and past drug history were reported as no. Concomitant medications were reported as not applicable. 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 four weeks prior to the COVID-19 vaccine. On an unknown date in Apr2021, a week after receiving the vaccine the patient experienced itchy and flushed on back of hands, elbows, thighs, knees for past 4 days. No visible, regular rash. Knuckles, elbows, knees flushed in red and warm. Therapeutic measures were taken for the reported events and included treatment with oral antihistamine(unspecified). Itching had minimally reduced with oral antihistamine. 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 Itchy rash, flushed and red rash was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
31 2021-07-28 feeling hot, numbness Red dots all over lips and nose, face red (same as sunburn); Numb right arm; Left arm only numb at i... Read more
Red dots all over lips and nose, face red (same as sunburn); Numb right arm; Left arm only numb at injection site; Very hot head and neck; Dizziness; Anxiety; Nasal congestion; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male 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 06Apr2021 at 08:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included generalized anxiety disorder. The patient was not allergic to food, medications, or other products. Concomitant medications included nicotinic acid (NIACIN), garlic extract and cayenne pepper. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 13:30, the patient experienced red dots all over lips and tip of nose, numb right arm, left arm only numb at injection site, very hot head and neck, red face which was same as sunburn, dizziness, anxiety and nasal congestion. The patient did not receive any treatment for the 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 events red dots all over lips and tip of nose, numb right arm, left arm only numb at injection site, very hot head and neck, red face which was same as sunburn, dizziness, anxiety and nasal congestion were resolved on 06Apr2021. No follow-up attempts are needed. No further information is expected.
32 2021-01-01 tingling, numbness Less than 5 minutes after receiving vaccine the left side of my face went numb (same side as injecti... Read more
Less than 5 minutes after receiving vaccine the left side of my face went numb (same side as injection) as if I had a lidocaine injection. This lasted about 45 minutes to an hr and then self resolved. No slurred speech or facial drooping evident although I didn't look in a mirror. Later in evening I experienced pins/needles in left arm similar to reduced blood circulation.
32 2021-01-03 pain in extremity arm pain
32 2021-01-04 feeling cold, pain in extremity I got my first dose 12/18/20, minimal symptoms, sore arm that lasted about 24 hours, consistent with... Read more
I got my first dose 12/18/20, minimal symptoms, sore arm that lasted about 24 hours, consistent with every years flu shot. 2nd dose 1/4/21, completely different experience. I was forwarned that the first dose primes the immune system, 2nd can be worse, so I was taking 600 mg Motrin q6 hours. Despite that, my arm progressively hurt worse and worse until now I can?t lift it above my waist. Full body aches and pains. Horrible chills and so cold. 102.1 F is highest temp so far, but that?s on top of scheduled Motrin. Still glad that I got it, but man does it suck right now.
32 2021-01-04 tingling, numbness He got a little bit of tingling in his left arm; headache; Muscle soreness in the arm the vaccine wa... Read more
He got a little bit of tingling in his left arm; headache; Muscle soreness in the arm the vaccine was administered; His thumb looks swollen and inflamed; Muscle weakness; Experiencing swelling in left arm/thumb and numbness from tip of thumb to joint on opposite limb of administration.; Experiencing swelling in left arm/thumb and numbness from tip of thumb to joint on opposite limb of administration.; This is a spontaneous report from a contactable consumer (patient) reported that a 32-year-old male patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685 and Expiration Date 31Mar2021) intramuscularly on 22Dec2020 15:00 at single dose for Vaccination (covid-19 immunization). The patient's medical history and concomitant medications was reported as none. The patient experienced swelling in left arm/thumb and numbness from tip of thumb to joint on opposite limb of administration. Since Wednesday, 23Dec2020, he has been experiencing some numbness in the arm opposite of where the vaccine was administered. He clarifies the vaccine was administered in the deltoid of his right arm, and the numbness he is experiencing is in his left hand. His thumb has been partially numb since last Wednesday. He got a little bit of tingling in his left arm since last Wednesday (23Dec2020).The patient explains on Tuesday, 22Dec2020, when he was administered the vaccine he only had typical side effects that went away within 24 hours. He experienced headache and muscle soreness in the arm the vaccine was administered. Both of these symptoms went away and he has recovered completely. After 24-36 hours, he noticed numbness on hand opposite of the arm where the vaccine was administered. His thumb has been partially numb which has lasted about 6 days. He clarifies the numbness is on the palm side- which he was told was not related to the nerve. His thumb looks swollen and inflamed compared to the other. He also has noticed muscle weakness in the opposite arm. The patient states he can't recall if the numbness occurred within 24 hours but he knows by 24 hours, he did have the numbness. His thumb is partially numb on the side of the palm and up to the middle of his thumb where the joint is.Patient states yesterday the numbness was noticeably worse when he was sleeping. However, today the numbness seems to be back where it was before. He forgets about the numbness since he is not actively doing anything with that particular hand, but he doesn't forget about it completely. The numbness hasn't improved any, it's been consistently there and never went away. While reading off of his card, the patient cannot determine if the Lot number is an F or an E because the number is underlined. He thinks it might be an E. Patient was able to confirm the Lot number begins with an E after looking at the information sheet he was provided. He also sees the product number, CVX 208. Patient states he has no allergic reactions and nothing that he knows of that is an underlying condition. Patient states he hasn't had any testing done in regards to these events. He wanted to talk to the manufacturer and report it to the (Contact center name) first before he schedules something at Urgent Care. He wanted to check and see if what he is experiencing is a lesser known symptom. He couldn't find this information anywhere. The outcome of events, headache and muscle soreness was recovered on 23Dec2020. The outcome of Numbness in hand was not recovered. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
32 2021-01-06 pain in extremity Fever right arm pain, chills, exhaustion Narrative: Vaccine 12/28 1700 12/28 - 12/29 - overnight wok... Read more
Fever right arm pain, chills, exhaustion Narrative: Vaccine 12/28 1700 12/28 - 12/29 - overnight woke up several times feeling sick. He had chills. Temp was 99-100. Exhaustion. 12/30 - this morning symptoms his symptoms are still present but improved. Chills, exhaustion. Hasn't checked his temperature this morning. Right arm - hurt on 12/28 and resolved as of 12/30. He took off from work 12/29 - 12/30. 12/31 - Symptoms have all resolved as of later 12/30.
32 2021-01-06 tingling Parasthesia on injection arm and parasthesia on ipsilateral skull base
32 2021-01-07 pain in extremity Body aches, arm soreness
32 2021-01-07 tension headache Mild to moderate pain at injection site.; Severe tension headache that started approximately 24 hour... Read more
Mild to moderate pain at injection site.; Severe tension headache that started approximately 24 hours after injection and lasted approximately 18 hours; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received the first dose of bnt162b2 (COVID 19 vaccine, brand: Pfizer) lot no: EH9899, via an unspecified route of administration in left arm on 27Dec2020 12:30 at a single for COVID-19 immunization in workplace clinic. There were no relevant medical history and concomitant medications. The patient had no COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. No known allergies. The patient did not receive other vaccines in four weeks or other medications in two weeks. On 28Dec2020 at 12:00 pm, the patient experienced mild to moderate pain at injection site. Severe tension headache that started approximately 24 hours after injection and lasted approximately 18 hours. The events were alleviated by single acetaminophen (TYLENOL) and sleep. The events were reported as non-serious. The patient recovered from the events.
32 2021-01-09 bell's palsy, facial paralysis Potential Bell's Palsy 8 days post Pfizer BioNtech COVID19 Vaccine Dose #1 Per documentation from e... Read more
Potential Bell's Palsy 8 days post Pfizer BioNtech COVID19 Vaccine Dose #1 Per documentation from emergency department provider: 32 y/o M who comes in from home for a new onset facial droop. Pt states that this is sudden onset today. he is unsure if it is related to the recent covid vaccine but has otherwise been well. He has no recent viral sx. He has no other neuro sx. He did have some pain in the jaw at the onset but that has since resolved. CT head obtained more for the jaw pain and to ensure no mass etc. It is normal. I discussed at length with the pt that I suspect this is bells palsy as he has very minimal movement of the forehead, cannot fully blink the L eye closed and has no risk factors for stroke. I did offer him further imaging to make 100% sure this is not a stroke but he agrees that he feels he has bells palsy and declined further labs or imaging. i will have him f/u with ENT as an OP. Given return precautions and f/u with them in the office. Given first dose of steroids and valacyclovir here. He will use artificial tears and tape the eye at night. .
32 2021-01-09 bell's palsy Anaphylaxis Please note previous VAERS report of Bell's Palsy 8 days following the first dose and s... Read more
Anaphylaxis Please note previous VAERS report of Bell's Palsy 8 days following the first dose and subsequently treated with prednisone and valacyclovir. This neurologic diagnosis was not reported by the patient during the consent process with the COVID19 vaccination center staff. Confirmed following review of the consent form. Documentation from Emergency Department Provider: Patient is serially reassessed following treatment for anaphylaxis. Patient has significant improvement in diffuse erythema and hives within 20 minutes. He has gradual improvement in his sensation of throat swelling. He is observed while in the emergency department serially over 4 hours with no recurrence of symptoms. He does not require any repeat dose of epinephrine and feels at baseline. Discussed my suspicions that patient may have had a reaction to COVID-19 vaccine as he has had no other new medications or exposures that he is aware of. As he will not be receiving another vaccine there is nothing to necessarily stay away from. Make sure he notifies individuals about this for any new vaccine should he receive them. Patient is observed for sufficient time but discussed possibility for biphasic reaction. Recommend he return should he have recurrence of symptoms. Recommend he take EpiPen as prescribed for any throat swelling or progressive shortness of breath. Recommend follow-up with a primary care provider for this visit..
32 2021-01-09 pain in extremity, tingling With in 12 hours had muscle soreness in right arm, headache. Got weakness in arm for 2 weeks. Shooti... Read more
With in 12 hours had muscle soreness in right arm, headache. Got weakness in arm for 2 weeks. Shooting pains in arm. Feels like a pinched nerve when the left arm in moved. Numbness in thumb.
32 2021-01-10 weakness Soreness, weakness, fatigue, and short term fever; treatment none; fever ended in hours; fatigue and... Read more
Soreness, weakness, fatigue, and short term fever; treatment none; fever ended in hours; fatigue and soreness decreased over 1-2 days
32 2021-01-10 burning sensation Itchy/burning sensation on tongue, associated with an altered taste with food and metallic taste in ... Read more
Itchy/burning sensation on tongue, associated with an altered taste with food and metallic taste in mouth. Symptoms began 12:00 pm 01/11, with metallic taste onset at 15:15 01/11.
32 2021-01-10 migraine chills, migraine, cotton mouth, whole body muscle aches, congestion. Was woken up by chills and head... Read more
chills, migraine, cotton mouth, whole body muscle aches, congestion. Was woken up by chills and head. Went to shower and sat in hot shower for 25-30 minutes. got out. chills returned, got back in shower for 10 minutes. took excedrin and then went back to bed with heat blanket.
32 2021-01-10 migraine fever, migraine. called in sick to work.
32 2021-01-11 facial paralysis, tingling Following the first COVID vaccine dose on Dec/18/2020, I had headaches that started on the third day... Read more
Following the first COVID vaccine dose on Dec/18/2020, I had headaches that started on the third day and ended on the tenth day. The headaches were usually light, unilateral, and alternating from one side to the other. I was usually functional except on the fourth and seventh days where the headaches were moderate to severe, and I took naps to help with the headaches for those two days. I have never had an issue with headaches before, and these symptoms were a new experience for me. I did not take any medications as treatment for the headaches. Following the second COVID vaccine dose on January/7/2021, I felt fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On January/10/2021, when I woke up that morning I again felt light, unilateral, and alternating headaches. In addition, I noticed that I was unable to move the left side of my face. I felt moderate tingling sensations associated with the distribution of the paralysis. When I looked in the mirror, I could quite noticeably see asymmetry in my face. I immediately went to the emergency department at the hospital where my primary care doctor is located. I was kept in the hospital into the next day for observation. After evaluation by a neurology team and an MRI, I was provided with the diagnosis of Bells Palsy. I have never previously been diagnosed with Bells Palsy, and I have never previously had a hospital stay before. The doctors prescribed medications which I am currently taking. As of today January/12/2021, the symptoms have had some improvement, but the symptoms still continue.
32 2021-01-11 feeling cold suspected COVID-19; suspected COVID-19; Fatigue; Body aches; Headache; chills; The initial case was ... Read more
suspected COVID-19; suspected COVID-19; Fatigue; Body aches; Headache; chills; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), intramuscular in the left deltoid on 15Dec2020 at 21:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing hypertension from 2009 and COVID-19 from 10Jun2020 to an unknown date in 2020. Ongoing concomitant medications included fosinopril (MANUFACTURER UNKNOWN) taken for hypertension from 2017. The patient did not receive any other vaccines on the same day as the BNT162B2 vaccine. On 19Dec2020, shy of about 96 hours of getting the vaccine, the patient experienced fatigue, body aches, headache and chills. He did not have any fever. The patient stated that he recovered from the fatigue, body aches, headache and chills by 19Dec2020. The patient was fine from 19Dec2020 until 01Jan2021. On 28Dec2020, the patient had a COVID-19 PCR test that came back negative. On 01Jan2021, the patient suspected that he had COVID-19. He had a fever of 103.1 degrees Fahrenheit, body aches, chills like he was freezing to death, fatigue, diarrhea; however, he did not have nausea or loss of taste or smell. He had swollen lymph nodes, but no sore throat and his oxygen saturation was okay in Jan2021. He was also having chest pain but it was more like intercoastal pain. He stated that these current symptoms were significantly worse than the ones he had just after getting the vaccine and felt more like the symptoms he had when he had COVID-19 before on 10Jun2020 (positive IgG for COVID-19-tested in 2020). The patient had a COVID nasal swab (PCR) done at an urgent care (physician's office) on 02Jan2020 or 03Jan2020 and was awaiting the results. The clinical outcome of the suspected COVID-19 was not recovered.; Sender's Comments: A causal association between reported suspected COVID-19 cannot be excluded.
32 2021-01-11 pain in extremity 32 yo male received 2nd dose of Pfizer/BioNTech Covid19 vaccine. 3 days later developed itching and ... Read more
32 yo male received 2nd dose of Pfizer/BioNTech Covid19 vaccine. 3 days later developed itching and urticarial rash all over his torso, arms, and legs. Eyelids slightly swollen. No shortness of breath, tongue or lip swelling, wheezing, nausea, diarrhea, cough, fever. Presented to ED, received diphenhydramine, famotidine, and methylprednisolone IV. Had significant improvement of urticarial rash and eyelid swelling. Patches still present. Discharged home on 5 day course of H1/H2 blocker and prednisone. After first Pfizer Covid19 vaccine dose, patient only had sore arm. In ED, chest xray has no radiographic evidence of an acute cardiopulmonary abnormality, PCR panel (Cepheid GeneXpert System) negative for Covid19, influenza A/B, RSV. No new food or detergents in last couple days. No other vaccines administered in last 30 days. This event is being described a couple hours after ED discharge. Unknown at this time if patches resolved with subsequent discharge home treatment.
32 2021-01-12 weakness Swelling of throat, face and weakness
32 2021-01-12 migraine Severe migraine with vomiting and visual aura (never happened to me before)
32 2021-01-12 tingling Patient felt tingling and dizziness. Drank water and stayed for additional observation. Symptoms res... Read more
Patient felt tingling and dizziness. Drank water and stayed for additional observation. Symptoms resolved.
32 2021-01-13 night sweats Developed subjective fevers and night sweats the night after receiving the second dose. Upon waking,... Read more
Developed subjective fevers and night sweats the night after receiving the second dose. Upon waking, I had significant chills, muscle and body aches, and fatigue. These symptoms lasted between 12-24 hours.
32 2021-01-14 weakness I was sitting down at work when out of the blue I experienced heart palpitations, lightheadedness, w... Read more
I was sitting down at work when out of the blue I experienced heart palpitations, lightheadedness, weakness and shortness of breath that lasted for about an hour. I went to the Emergency Room and by the time I was triaged the symptoms went away. My blood pressure was 150/90 at triage with other vitals within normal limits. I did get an EKG which was negative. I was given Valium 5mg and discharged with a diagnosis of Panic Attack.
32 2021-01-18 pain in extremity woke up with fever to 102F; rigors; body aches; headache; R arm pain and redness at injection site; ... Read more
woke up with fever to 102F; rigors; body aches; headache; R arm pain and redness at injection site; R arm pain and redness at injection site; R arm pain and redness at injection site; the 1st dose on 22Dec2020, the 2nd dose on 08Jan2021; This is a spontaneous report from a contactable Physician (patient). This 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the 1st dose on 22Dec2020, the 2nd dose (lot number: EL0142) on 08Jan2021; both at right arm via an unspecified route of administration at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. 12 hours after vaccine, the patient woke up with fever to 102F, rigors, body aches, and headache on 09Jan2021. Severe symptoms until around 24 hrs, then continued mild body aches and chills up to 50 hours after shot. Continued R arm pain and redness at injection site currently, at 72 hours after vaccine. No treatment was received for events. The patient had no COVID prior vaccination, no COVID tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of all events was recovered. No follow-up attempts are possible. No further information is expected.
32 2021-01-19 difficulty speaking 14th Jan-lump left-groin-lymph node, he feels it, body aches, 15th Jan-feeling better-slept-all day... Read more
14th Jan-lump left-groin-lymph node, he feels it, body aches, 15th Jan-feeling better-slept-all day 16th Jan-lay in bed 15 & 16th Jan till noon-holiday week-end 17th Jan-lay in bed 18th Jan-lay in bed 19th Jan- lump in left neck-lymph node he says-enlarged-he feels it-hoarse like sound in his voice 20th today-Jan-better today-feels like he is getting to FLU-nose runny
32 2021-01-20 discomfort Patient is a 32-year-old male with history of cervical disc herniation and bilateral upper extremity... Read more
Patient is a 32-year-old male with history of cervical disc herniation and bilateral upper extremity radiculopathy presents with complaint of left hand tightness 5 minutes after receiving a COVID-19 vaccine. Patient was unsure if this was allergic reaction and was sent here for evaluation. Patient denies any difficulty with breathing.
32 2021-01-23 migraine Muscle stiffness through out the body, headach/migraine, sore area at injection site with tenderness... Read more
Muscle stiffness through out the body, headach/migraine, sore area at injection site with tenderness. All of this was after the second dose.
32 2021-01-24 tingling, facial paralysis Unable to move the left side of my face/I could quite noticeably see asymmetry in my face/I was prov... Read more
Unable to move the left side of my face/I could quite noticeably see asymmetry in my face/I was provided with the diagnosis of Bells Palsy; I felt moderate tingling sensations associated with the distribution of the paralysis; Generalized muscle aches; I felt fatigue; Dizziness; This is a spontaneous report from a contactable Physician. A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246) on 07Jan2021 at 09:00 a.m. intramuscular on left deltoid, at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 on 18Dec2020 at 09:00 on left arm (lot number: EK5730) and experienced headaches that started on the third day and ended on the tenth day. Following the second dose on 07Jan2021, patient experienced fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On 10Jan2021, he noticed that was unable to move the left side of his face. He felt moderate tingling sensations associated with the distribution of the paralysis. When looked in the mirror, he could quite noticeably see asymmetry in his face. Patient immediately visited emergency department at the hospital where his primary care doctor was located. Patient was kept in the hospital into the next day for observation (as reported). After evaluation by a neurology team and an MRI, patient was diagnosed with Bells Palsy. He had never previously been diagnosed with Bells Palsy, and never previously had a hospital stay before. It was also informed that patient underwent Nasal Swab for SARS-CoV-2 test on an unspecified date in Dec2020 and on 10Jan2021, both resulted negative. At the time of the reporting, the symptoms continued.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diagnosed Bells Palsy presented as unable to move the left side of his face/felt moderate tingling sensations associated with the distribution of the paralysis/asymmetry in his face 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.
32 2021-01-25 tremor Fever; Body aches; Chills; Tremors; Headache; This is a spontaneous report received from a contactab... Read more
Fever; Body aches; Chills; Tremors; Headache; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 32-year-old male patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date: unknown), intramuscular in the left arm, on 12Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included Sleep apnea, asthma, gastrooesophageal reflux disease (GERD), hypertension and anxiety. The patient did not have COVID-19 prior to vaccination. The patient had no known allergies. Historical vaccines included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), via an unspecified route of administration in the left arm, on 29Dec2020 for immunization; and the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: unknown), intramuscular in the left arm, on 21Dec2020 15:15, for COVID-19 immunization. The patient experienced fever, body aches, chills, tremors and headache on 12Jan2021 23:00. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.
32 2021-01-26 discomfort Large nodule on left side of neck; Lymphadenopathy; Some pain occurs when straining neck, but mostly... Read more
Large nodule on left side of neck; Lymphadenopathy; Some pain occurs when straining neck, but mostly just very uncomfortable; Some pain occurs when straining neck, but mostly just very uncomfortable; Some pain occurs when straining neck, but mostly just very uncomfortable; This is a spontaneous report from a contactable pharmacist (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:00 (at the age of 32-years-old) at a single dose for COVID-19 immunization. Medical history included penicillin allergy and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced large nodule on left side of neck, lymphadenopathy, and some pain occurs when straining neck, but mostly just very uncomfortable on 16Jan2021. The clinical course was reported as: The patient woke up the morning after being vaccinated and had a large nodule on left side of neck, which appeared to be lymphadenopathy. There was some pain that occurred when straining neck, but patient was mostly just very uncomfortable. The patient did not receive any treatment for the events. The clinical outcome of large nodule on left side of neck, lymphadenopathy, and some pain occurs when straining neck, but mostly just very uncomfortable was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
32 2021-01-27 weakness, night sweats Pain at injection site; Severe headache; Myalgias; Fever; Chills; Night sweats; Weakness; This is a ... Read more
Pain at injection site; Severe headache; Myalgias; Fever; Chills; Night sweats; Weakness; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK4176), via an unspecified route of administration in right arm, on 13Jan2021 at 10:15, 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 (Lot Number: EK9241) on 24Dec2020 at 12:15 PM for COVID-19 immunization (left arm) and developed pain at injection. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The facility where the vaccine was administered was in a hospital. On 13Jan2021 at 8 PM after the second dose, the patient developed pain at injection site similar to the first dose but also developed severe headache, myalgias, fever, chills, night sweats, and weakness about 8-10 hours after the injection that lasted throughout the night. The patient was currently more than (>) 24 hours after the second injection and while most symptoms have resolved, the patient still had significant weakness and myalgias. Treatment was received for the events including paracetamol (TYLENOL). Post-vaccination, the patient has not been tested for COVID-19. The patient was recovering from "Myalgias" and "Weakness". The patient recovered from the remaining events in Jan2021.
32 2021-01-28 pain in extremity This is a spontaneous report from a contactable consumer. A 32-year-old male patient received bnt162... Read more
This is a spontaneous report from a contactable consumer. A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the left arm on an unspecified date in Dec2020 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. He had no known allergies. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. He was not tested for Covid post vaccination. The patient's injection arm and entire upper body was sore for roughly 3 days on an unspecified date in Dec2020. The patient did not receive any treatment for the events. The patient recovered from the events on an unspecified date. Information on the lot/batch number has been requested.
32 2021-01-29 pain in extremity, muscle spasms Bilateral lower thigh soreness starting 2 days after vaccine (12/21/20) subsequently developing into... Read more
Bilateral lower thigh soreness starting 2 days after vaccine (12/21/20) subsequently developing into severe bilateral lower thigh pain and cramping 3 days after the vaccine (12/22/20) persisting for approximately 2 weeks. Confirmed as rhabdomyolysis with elevated CK on 12/29/20, and saw physician on 1/2/21, with subsequent downtrending CK but elevated on 1/2/21.
32 2021-02-01 pain in extremity 2 HOURS AFTER INJECTION I EXPERIENCED SORENESS AT THE INJECTION SITE. 13.5 HOURS AFTER INJECTION I W... Read more
2 HOURS AFTER INJECTION I EXPERIENCED SORENESS AT THE INJECTION SITE. 13.5 HOURS AFTER INJECTION I WOKE UP WITH A FEVER AND CHILLS. I TOOK ONE TYLENOL WHEN THE FEVER AND CHILLS WOKE ME. THE FEVER AND CHILLS LASTED APPROXIMATELY 3 HOURS. THE SORENESS HAD SPREAD TO MY UPPER BODY BY 4AM, 17.5 HOURS AFTER INJECTION. THE SORENESS/BODYACHE PERSISTED FOR THE DAY FOLLOWING INJECTION. I DID NOT SEE A DOCTOR AS THE SYMPTOMS RESOLVED THEMSELVES.
32 2021-02-02 night sweats Fever up to 106, extreme headache, chills, and night sweats
32 2021-02-03 pain in extremity scheduled for the same day as the 2nd Hep B vaccine; scheduled for the same day as the 2nd Hep B vac... Read more
scheduled for the same day as the 2nd Hep B vaccine; scheduled for the same day as the 2nd Hep B vaccine/ realized they were not supposed to give vaccinations like that, the error was caught; Received his first dose of Covid19 vaccine on 18Dec2020/ Received his second Covid vaccine on 11Jan2021; Pain in the left arm; Felt woozy/Small bouts of dizziness; Felt nausea; Not too much pain around the injection site; Rise in temperature of 97.7 to 99.9; This is a spontaneous report from a contactable consumer reporting for himself. A 32-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 08:45 at single dose, left arm (lot number EK5730); and second dose via an unspecified route of administration on 11Jan2021 at single dose, right arm (lot number EJ1685) for COVID 19 prevention; hepatitis b vaccine (manufacturer unknown), via an unspecified route of administration on 14Dec2020 at single dose (arm once) for immunisation (Prerequisites of working in long term care facility). Medical history reported as none. There were no concomitant medications. The patient received the Pfizer-Biontech Covid19 vaccine in within a close interval with a Hepatitis B vaccination. On 14Dec2020, patient received the Hepatitis B vaccination 4 days prior to COVID-19 vaccine which patient reported was not recommended, then received his first dose of Covid19 vaccine on 18Dec2020 (he was 32 years old at that time, he turned 33 years old on 25Dec2020). He received his second COVID vaccine on 11Jan2021. Patient reported he has since learned that a dosing interval of 14 days is usually recommended. Patient stated this was not supposed to be done within 14 days. He stated that CDC mentioned that three vaccines that were possible to do this but unknown safety hazards to doing this. Stated that it did not mention Hepatitis B. Stated it was an error on nurse's judgement. He stated there was a second co-administration to happen on Monday, patient was scheduled for the same day as the 2nd Hep B vaccine (unknown date), but that she was on vacation. He stated that the person could not find Hepatitis B vaccine. He stated that his original paperwork was not filed. He stated that he got a second COVID 19 on Monday, and on Wednesday (13Jan2021) they realized they were not supposed to give vaccinations like that, the error was caught, and he would not get the second Hepatitis B vaccine. Stated that he was unaware of any symptoms that occurred immediately after vaccination. He wanted to know how to proceed from this point. Patient stated that It was the person in charge of vaccinations told him there was no problem giving co-administration of COVID-19 vaccine. He also reported mild adverse events after both COVID vaccines which include not too much pain around the injection site, some nausea 10-12 hours after the injection; felt woozy/small bouts of dizziness, pain in the left arm at 17:00 (to point could not lift or sleep on it), rise in temperature of 97.7 to 99.9 (also reported as for 5-6 days were at 99.9 never breaking 100) on 18Dec2020. Treatment was not given for all events. Patient had blood work done on an unspecified date with unknown results, and rise in temperature of 97.7 to 99.9 on 18Dec2020 and 11Jan2021. Outcome of the events rise in temperature of 97.7 to 99.9, pain in the left arm was recovered on an unspecified date; events felt woozy/small bouts of dizziness and felt nausea was recovered on 18Dec2020, while outcome of not too much pain around the injection site was unknown.
32 2021-02-04 tingling A few hours after injection I began to feel faint pins and needles feelings on skin throughout my bo... Read more
A few hours after injection I began to feel faint pins and needles feelings on skin throughout my body. Not concentrated in any specific location. Comes and goes. Is not painful, but has lasted 4 days now.
32 2021-02-04 unresponsive to stimuli, slurring Patient received his vaccine and was waiting in the post-vaccination waiting space. Within 5-10 minu... Read more
Patient received his vaccine and was waiting in the post-vaccination waiting space. Within 5-10 minutes he slumped in his chair and became unresponsive. Became responsive to voice but was slurring his words. Patient was diaphoretic. HR in 90s, O2 98%. His eyes rolled back in his head suspecting vasovagal episode, we moved patient to the floor and raised his legs. He became more responsive. Was fully oriented although did not seem incredibly alert. Cycled multiple BPs with 100s-110s/60s-70s. HR 70s-80s supine, O2 sat 96-98%. EMS was called for transport to ED given patient's lack of prompt recovery. We attempted to sit patient up and he again became lightheaded and had to lie back down. While in supine position, remained with normal and stable VS. At no time did he manifest any rash, respiratory symptoms, throat or chest tightness, abdominal discomfort, or other overt signs of anaphylaxis. Patient was transported to the ED where ROS was reported as: - CONST: +fatigue, denies fevers or chills - EYES: Denies vision changes - ENT: Denies rhinorrhea, sore throat - CV: Denies new chest pain - RESP: Denies SOB or cough - GI: Denies abd pain, n/v, diarrhea - GU: Denies dysuria - MSK: Denies new joint swelling or pain - SKIN: Denies new lesions or rash - NEURO: Denies new HA, numbness, or weakness - PSYCH: Denies suicidal ideation Vitals: BP 116/67, O2 99% on RA, Temp: 97.7F, Pulse 79. ED provider felt this was most likely vasovagal episode given occurrence following vaccine administration and associated sxs. EKG without evidence of dysrrhythmia. No PE risk factors, SOB or CP. Pt with HA that was not thunderclap nor severe in nature and was consistent with prior migranes, thus do ot suspect SAH. No hx to suggest anemia and no anemia on blood work today. No report of seizure. Pt is alert without report of post-ictal period.
32 2021-02-10 seizure Had back to back seizures 2 days after getting the vaccine (1/27/21). Hospitalized for 48 Hours. Cam... Read more
Had back to back seizures 2 days after getting the vaccine (1/27/21). Hospitalized for 48 Hours. Came back and had another seizure after discharging from ICU.
32 2021-02-10 seizure Had back to back seizures 2 days after getting the vaccine (1/27/21). Hospitalized for 48 hours. ... Read more
Had back to back seizures 2 days after getting the vaccine (1/27/21). Hospitalized for 48 hours. came back and had another seizure after discharging from ICU.
32 2021-02-11 migraine Patient stated he had a migraine after the vaccine. We were advised of a change in appetite on Thurs... Read more
Patient stated he had a migraine after the vaccine. We were advised of a change in appetite on Thursday February 4th. Patient died on February 6th.
32 2021-02-12 pain in extremity, migraine Sore arm, body aches, migraine, stiff lower back, chills, tiredness, smell/taste affected.
32 2021-02-17 migraine This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), at age 32 years, via an unspecified route of administration on the left arm, first dose on 29Jan2021 09:30, at single dose, for COVID-19 immunization. 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, was the patient was not diagnosed with COVID-19. On 30Jan2021 , the patient experienced migraine. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other medications within 2 weeks of vaccination. Treatment was not received for the adverse event. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the event was recovering. Information on the lot/batch number has been requested.
32 2021-02-22 weakness Began - General weakness, body aches, chills 12 hours later - 102 fever, full body/joint aches, chil... Read more
Began - General weakness, body aches, chills 12 hours later - 102 fever, full body/joint aches, chills 24 hours later - above continued 40 hours later - symptoms subsided fever came down below 100 minimal aches, etc 48 hours later - 102 fever, no body ache, chest/throat tightness (trouble deep breath), chills (considered urgent care) 64hours later - temp consistently normal bouts of chest tightness occasionally (believe fully recovered) Began regiment of Tylenol (500mg) every 4-6 hours (as close to 6 as possible) w inbuprphin (200mg) as needed (occasionally instead of Tylenol). Neither medication worked for all symptoms (Tylenol better for fever and chest tightness ibuprophin better for body aches)
32 2021-02-28 numbness, pain in extremity At approximately 15:30 began experiencing pain in right hand and wrist as well as headache. Then at ... Read more
At approximately 15:30 began experiencing pain in right hand and wrist as well as headache. Then at approximately 18:00 began noticing decreased feelings in right hand and wrist. By 19:00 lost all feelings in right hand and arm also notable drift on stroke screening. Was seen at approximately 19:30hrs for possible stroke. Released at 23:30hrs after all results were negative for stroke. Still experiencing symptoms until the following morning. From then extreme pain was noted around a 3 inch circle of injection resolving approximately 24 hours later.
32 2021-02-28 pain in extremity Pfizer Dose #1: I felt pain in my arm, which was expected immediately. In ten hours, I had 103F feve... Read more
Pfizer Dose #1: I felt pain in my arm, which was expected immediately. In ten hours, I had 103F fever, chills and tiredness. I can't even sleep all night. It was sore, tired and headache. I lost all of my smell & appetite. It took me four days to recover my body. Pfizer Dose #2: REPEAT it again
32 2021-03-01 slurring After vaccination, patient had slurred speech and syncopal
32 2021-03-02 unresponsive to stimuli During the safety briefing by staff, participant became unresponsive; participant was administered E... Read more
During the safety briefing by staff, participant became unresponsive; participant was administered Epi Pen 0.3 mg in left thigh. EMS was called. Participant then aroused and was assisted by staff to observation tent. Initially denied history of passing out with injections, however, later stated he had. Participant was incontinent of urine. Oxygen saturation - 99%, pulse 66. EMS arrived and assessed participant, BS 112, & offered to take to E.D. for further evaluation, however, participant declined & left with wife. Called to f/u on 3/3/21 and stated he had visited his physician and had no further concerns.
32 2021-03-03 feeling cold, tremor Constant shoot chills/sensation cin neck and back of head. Shaking sensation when laying down, inabi... Read more
Constant shoot chills/sensation cin neck and back of head. Shaking sensation when laying down, inability to sleep more than 2 hours due to aforementioned sensations.
32 2021-03-03 numbness NUMBNESS IN RIGHT CHEEK
32 2021-03-06 migraine, seizure After 23 hours of first dose had a less than ten second seizure. Last seizure over seven years ago. ... Read more
After 23 hours of first dose had a less than ten second seizure. Last seizure over seven years ago. Had a migraine that night before bed. After 53 hours of second dose had migraine headache at that night. Not able to clearly read the number on the CDC card with the EN number.
32 2021-03-07 pain in extremity About 2 hours after vaccine, became unusually tired, and napped for 2 hours. Felt fine when I woke ... Read more
About 2 hours after vaccine, became unusually tired, and napped for 2 hours. Felt fine when I woke up. Arm was mildly sore for about 2 days after the shot. Beyond that no other noticeable symptoms.
32 2021-03-09 tremor, unresponsive to stimuli Pt was riding with parents through drive through clinic. Received vaccine and proceeded to observati... Read more
Pt was riding with parents through drive through clinic. Received vaccine and proceeded to observation area, after approximately 13 minutes, pt's parent honked the horn and flagged down paramedic. Upon arrival, paramedic stated pt had a blank stare and was unresponsive. Supervisor notified and EMS was called. Pts hand began to tremor at 0940. VS were: BP 120/74, HR 100. Pt broke his blank stare, and stopped tremoring at 0949. EMS arrive at 0950. blood sugar taken- 123. Pt able to confirm orientation to self and location.
32 2021-03-11 numbness, tingling Tingling and numbness in feet, legs, and fingertips
32 2021-03-12 weakness Patient had expected discomfort at injection site for 1-2 days. Started feeling tired about 3-5 days... Read more
Patient had expected discomfort at injection site for 1-2 days. Started feeling tired about 3-5 days after injection but continue to function well. However, he has had progressive weakness, tiredness and falling asleep just couple hours after sleeping all night and it is at a point as of today where he cannot do his usual work. He also has headache and very cloudy mental status with inability to concentrate and loses his trend of thought. He is highly accomplished individual. He is a compulsive mask wearer and follows strict isolation guidelines. Please advise as we are becoming increasingly concerned.
32 2021-03-14 pain in extremity blacked out; Nausea; chills; sweating; muscle weakness; arm pain; fever; fell; This is a spontaneous... Read more
blacked out; Nausea; chills; sweating; muscle weakness; arm pain; fever; fell; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN5318) via an unspecified route of administration on Right arm, at the age of 32-year-old, on 27Feb2021 13:15, single dose, for covid-19 immunisation. Medical history included gastrooesophageal reflux disease. Concomitant medication included esomeprazole magnesium (ESOMEPRAZOLE [ESOMEPRAZOLE MAGNESIUM]) and garlic supplement. The patient previously took amoxicillin and experienced drug hypersensitivity and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6198) on 06Feb2021 13:15, at right arm, at the age of 32-year-old single dose for covid-19 immunisation. On 28Feb2021 at 04:00, 15 hours after the shot was administered, the patient experienced nausea, chills, sweating, muscle weakness, arm pain, fever, fell and blacked out twice. The patient did not receive any treatment in response to the events. The patient was not diagnosed with covid prior vaccination and was not tested for COVID post vaccination. Outcome of the events was recovering at the time of the report.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported loss of consciousness 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.
32 2021-03-15 speech disorder He had a syncopal event witnessed by his wife. He was leaning to the left when the staff came to be ... Read more
He had a syncopal event witnessed by his wife. He was leaning to the left when the staff came to be by his side. He was unable to speak, fixed stare with dilated eyes. He became pale and diaphoretic. During this time he had a strong pulse. He He quickly (within 5 seconds) was oriented and speaking again. He did this twice. His blood pressure was 110/60. He was then moved to a bench and his feet were elevated. He was able to drink and eat some crackers. 10 minutes later his BP was rechecked and was 100/60. He was no longer pink and was easily conversing. By 20 minutes later, he was able to be sitting up, normal color, pupils at normal size, stating he feels much better. BP was 110/64 at that time. He did state he has done this before when getting blood drawn. His wife was able to walk him out and drive him home.
32 2021-03-17 tingling pt. complain of sore throat and tingling of his right hand after the pfizer vaccination The symptom... Read more
pt. complain of sore throat and tingling of his right hand after the pfizer vaccination The symptoms were resolved and pt. went home in stable condition.
32 2021-03-18 unresponsive to stimuli felt injection, eyes in disarray, unresponsive, vomiting
32 2021-03-19 seizure Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: H... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Hypotension-Medium, Systemic: Seizure-Severe, Additional Details: Approx. 15 minutes after getting his COVID vaccine pt. notifed clinic staff that he was feeling unwell and his heartbeat was irregular. Pt. then started to collapse and after being assisted to the ground had a seizure lasting approx. 10 seconds. After waking back up from seizure pt. had trouble breathing. Clinic staff notified me and I immediately administered 0.3 mg of epinephrine via an auto-injector. 911 was called and Pt. was able to sit back up while he waited for EMS.
32 2021-03-19 tenderness Patient had just received his injection and just sat down in the observation area when he had a sudd... Read more
Patient had just received his injection and just sat down in the observation area when he had a sudden syncopal episode that was witnessed by other bystanders. EMS responded immediately. Patient was difficult to arouse, with some muscle rigidity. Patient returned to consciousness within 30 seconds. Patient was moved to WC, and still felt syncopal. HR was 62. Patient was laid down. Patient did have a small carpet burn on his right wrist, and some tenderness on his right side of his neck, and tenderness behind his left ear from his mask. After 30 minutes, patient was able to stand and walk without assistance. He was transported to home by his wife. Patient denied need for further medical assistance and would have his wife observe him at home.
32 2021-03-22 cold extremities, tingling Patient felt coldness and tingling down the right leg 15 minutes after administration. No loss of st... Read more
Patient felt coldness and tingling down the right leg 15 minutes after administration. No loss of strength, able to walk. After an additional 15 minutes the patient had improved.
32 2021-03-23 bell's palsy Developed Bell's palsy, was treated with prednisone and valtrex, almost completely resolved by 3/24/... Read more
Developed Bell's palsy, was treated with prednisone and valtrex, almost completely resolved by 3/24/2021, he had previously when he was 15 or 16 years of age with complete resolution, was told at that time that it may recur, given over one month doubt if from the vaccine but wanted to report since may be important in data collection
32 2021-03-23 flushing Mild swelling of the tongue, lips and face, feeling flushed, itchy upper back.
32 2021-03-23 pain in extremity, burning sensation About two weeks after first shot, I got shingles. It could be unrelated, but since I'm young, perfec... Read more
About two weeks after first shot, I got shingles. It could be unrelated, but since I'm young, perfectly healthy, not abnormally stressed, and haven't ever had singles before, I thought there might be a chance it is related. I've seen online other young people who are saying that they got shingles after the first shot of Moderna or Pfizer. Maybe it was just a coincidence, but I figured it was worth reporting. It is overall a pretty mild case because I got on the antiviral drugs pretty quickly. Wondering if I should still get my second shot on schedule or wait until my shingles is all cleared. I have asked my doctor and am awaiting a response. I first noticed the symptoms on Saturday (3/20) exactly two weeks after my first shot.
32 2021-03-23 pain in extremity Within 48 hours of receiving the vaccine on 17-MAR-21, my left arm became notably painful and weaker... Read more
Within 48 hours of receiving the vaccine on 17-MAR-21, my left arm became notably painful and weaker, seemingly an unusual shoulder pain. On 24-MAR-21, my condition remained the same, so I attempted to contact Healthcare facility (vaccine administrator), but was then directed to consult my primary physician. The Clinic then directed me to contact the Healthcare facility. Eventually, I was able to get an appointment with the Clinic, and the dr proscribed me a 6-day steroid regime (Methylpredinsolone 4 MG tablet) to attempt to reduce pain.
32 2021-03-24 feeling cold Tiredness and chills next day. Severe headache and night sweats evening of the next day. 2 days late... Read more
Tiredness and chills next day. Severe headache and night sweats evening of the next day. 2 days later an itchy, raised, red rash appeared on arms and some spots on torso when I went outside. They went away shortly after returning inside. This continued to happen any time I went outside for greater than a 15 minute duration and lasted for 2-3 weeks.
32 2021-03-24 numbness facial numbness, lips numb swelling, tongue swelling, nape of neck itching
32 2021-03-24 migraine -Onset after 1 hour - light-sensitivity migraine. Children's dose aspirin taken and decreased in sev... Read more
-Onset after 1 hour - light-sensitivity migraine. Children's dose aspirin taken and decreased in severity at 37 hours. -Onset after 4 hours - altered temperature, between 95.9 F - 97.1 F (average is 98.2 F). Ongoing symptom after 96 hours (97.1 F as of typing this, taken on the hour). -Onset after 6 hours - feeling of physical exhaustion without sleepiness. Decreased in severity at 70 hours. -Onset after 18 hours - bone and joint pain, focused in mid-back, shoulders, hips, knees, and ankles. Decreased in severity at 42 hours. -Onset after 21 hours - Decreased mobility in shoulders, hips, and ankles. Decreased in severity at 38 hours.
32 2021-03-25 seizure At approx. 1015 pt began to seize in chair and fell off chair. Pt continued seizing after fall. Anot... Read more
At approx. 1015 pt began to seize in chair and fell off chair. Pt continued seizing after fall. Another pt sitting next to pt placed pt onto left side during seizure. Nurse assumed care at approx. 1015. Nurse observed tonic-clonic seizure lasting approx. 30 seconds total. After seizure ended, pt had unlabored breathing and appeared foggy for approx. 10 seconds. Patient was then AxO x4. Pt reported 7/10 pain on left side of head and feeling tired. Pt reported no Hx of seizures and no blood thinners. 911 activated at approx. 1016. Pt denied taking any meds and any chronic medical conditions. Paramedics arrived and assumed care at approx. 1024. At approx. 1026, pt left facility via ambulance and transported to ER for further care.
32 2021-03-27 tingling Soon after vaccination patient felt very light headed. No Syncope. States always feels like this wit... Read more
Soon after vaccination patient felt very light headed. No Syncope. States always feels like this with needles.
32 2021-03-28 bell's palsy Right sided Bell's palsy developed 10 days after 1st dose of Pfizer Covid-19 vaccine. Has been sta... Read more
Right sided Bell's palsy developed 10 days after 1st dose of Pfizer Covid-19 vaccine. Has been stable on prednisone and valacyclovir without worsening.
32 2021-03-28 discomfort Auxiliary lymphadenopathy on the left side of the body from March 24 to approximately March 29. Di... Read more
Auxiliary lymphadenopathy on the left side of the body from March 24 to approximately March 29. Discomfort due to left auxiliary lymphadenopathy in armpit and a visible egg shaped swelling. Mild flu like symptoms of chills and joint aches occasionally from March 25 to March 26.
32 2021-03-29 flushing, unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Sev... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Additional Details: Pt was sitting for observation, after 8min, pt suddenly fell to lateral side, pt denies head trauma. IM Rx and Technician responded immediately.
32 2021-03-29 numbness Patient felt numbness in her vaccinated hand while driving home followed by sweating. Once home he s... Read more
Patient felt numbness in her vaccinated hand while driving home followed by sweating. Once home he started to feel better. No shortness of breath, difficulty breathing, rash or hives were reported. Once the follow up call was made, patient stated he feels fine.
32 2021-03-30 pain in extremity Tiredness and exhaustion in general/exhaustion/feeling like I am completely drained of energy; muscl... Read more
Tiredness and exhaustion in general/exhaustion/feeling like I am completely drained of energy; muscle and joint pain; muscle and joint pain; Pain in my arms and legs; Pain in my arms, back, and legs; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiration date not provided), via an unspecified route of administration on 05Jan2021, 10:30 in right arm and then via unspecified route of administration (Lot Number: EL8982, Expiration date not provided) on 25Jan2021, 07:30 in the right arm both for COVID-19 immunization. The patient's medical history included very slight allergy to Kiwi fruit. 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 had not been diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 26Jan2021, the patient experienced tiredness and exhaustion in general, performing any physical activity that requires a minor amount of effort leads to muscle and joint pain and exhaustion, while walking around the store pushing the cart has ended him calling out of work sick the next day due to pain in arms, back, and legs as well as feeling like he was completely drained of energy. It was reported that all events listed happened with the first shot and continued after the second dose but more severe. The patient had not received any treatment for the events. Outcome of the events was not recovered.
32 2021-03-30 pain in extremity Fever of 100.1, pain at site of injection, body aches at lower back/upper leg the morning after the ... Read more
Fever of 100.1, pain at site of injection, body aches at lower back/upper leg the morning after the shot.
32 2021-03-31 numbness, throat numbness After about 10 minutes, sensations of numbness in face and sinuses and throat and soft-pallet of the... Read more
After about 10 minutes, sensations of numbness in face and sinuses and throat and soft-pallet of the mouth.
32 2021-04-01 feeling hot, flushing Started with sweeping of hands, feeling hot and flushed, then redness of face. Extremely itchy. Fain... Read more
Started with sweeping of hands, feeling hot and flushed, then redness of face. Extremely itchy. Fainted once arrived to ER.
32 2021-04-01 flushing Racing heart(panic attack feeling), flush feeling in skin, intermittent body aches. Insomnia,
32 2021-04-03 tingling, inability to speak, numbness 8 minutes after I ejection left arm and entire face went numb along with pins and needles throughout... Read more
8 minutes after I ejection left arm and entire face went numb along with pins and needles throughout all of the body, lightheaded, dizzy. Day 1 minor aches, numbness still present. Day 2 severe chest pain, numbness still present. Went to urgent care, ekg preformed. Day 3 loss of equilibrium, severe vertigo, nausea, dizziness. This continued to get worse day 4 and 5, went to urgent care again. Still numb, tingling, vertigo, nausea. Blood work completed and nausea medication provided. Inability to speak or perform any movement without losing balance. Severe spinning sensation. Went to ER on day 9 all symptoms still remain. Numbness converted to painful tingling and movement throughout body. Vertigo medication, nausea medication provided. Suggested neurologist. Went to neurologist on day 12. Symptoms still remain. Neurologist suggested seeing a primary care internal dr.
32 2021-04-04 unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Severe
32 2021-04-05 tingling Increased heart rate within minutes of receiving the vaccine followed by a tightening of the throat ... Read more
Increased heart rate within minutes of receiving the vaccine followed by a tightening of the throat and tingling in the extremities. Symptoms lasted roughly 10 minutes before heart rate dropped to normal, but throat tightness lasted the rest of the evening.
32 2021-04-05 seizure, grand mal seizure Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Addi... Read more
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Pt was advised to set down in the waiting area for 15 minutes to be monitored, once in a sitting position patient started convulsing into a grand mal seizure, I immedietly ran to him, started restraining him and holding his head to prevent him from hitting the wall, patient was laid flat and restrained by family members and the nurse practitioner, seizure lasted for les than a minute, and patient started to regain consiousness. called 911
32 2021-04-06 flushing Approx. 11:40 or 11:45 Client passed out while seated in the back of the observation area Client fel... Read more
Approx. 11:40 or 11:45 Client passed out while seated in the back of the observation area Client fell to the side but landed face forward and sustained a laceration to the forehead near the hairline on the right side RN called 911 to dispatch EMS around 11:45 After the client passed out a fireman/EMT, physician and nurse were present to arouse the client and assess for further neck or brain injuries RN tended to the bleeding laceration Client gained consciousness and became alert Client able to answer questions Vaccine Administrator stated that the client mentioned that he was having chest pain but Client denied this and stated that he just felt nervous Client states that he passes out when giving blood and has a needle phobia Nurses and Fireman/EMT assisted client to a wheelchair and back to a private recovery area 11:52 Vitals obtained : O Sat 98, Pulse 56 BP 129/75 Client reports nausea, a flushed sensation, headache and dizziness No Vomiting noted Fireman/EMT took Blood sugar reading with Glucometer. Blood sugar reading is 83 Client reports feeling drowsy but he states that he did not sleep as much as he normally does last night Fireman/EMT reports Full range of motion to the neck and client reports no neck pain Ambulance arrives at 12:08 Client previous history was relayed to the paramedics : Vital assessed BP 127/80 and pulsometer in use Paramedic noted that client must have been wearing his sunglasses when he passed out because blood was present on the glasses and the laceration lined up with the sunglasses perfectly Client discussed what hospital he wanted to be transported to Client does not have a family physician Ambulance left within 10 to 15 minutes after arrival
32 2021-04-06 numbness Patient felt numb on hands, sweating, and fainting after receiving the covid vaccine from the pharma... Read more
Patient felt numb on hands, sweating, and fainting after receiving the covid vaccine from the pharmacy.Patient was full alert and responded to all the requests. We did call and EMS arrived. They did check patient health and everything was normal . Patient did not want to go to the hospital and felt better after drinking a bottle of orange juice. EMS crew left the pharmacy after 10 minutes. Patient sit down on a chair and drank another bottle of water. He felt very well and wanted to left the pharmacy.
32 2021-04-07 weakness Fever, body aches, headache, nauseia, chills, sweats, weakness, fatigue, loss of appetite. Began to... Read more
Fever, body aches, headache, nauseia, chills, sweats, weakness, fatigue, loss of appetite. Began to feel weak and chill in the evening, sweat profusely all night.
32 2021-04-07 discomfort -Fever beginning around 12 hours after injection. At 24 hours, fever hovered between 101-102. At aro... Read more
-Fever beginning around 12 hours after injection. At 24 hours, fever hovered between 101-102. At around 36 hours, fever hit 103.2. By 48 hours, fever dropped to around 100. -Full body aches that correlated with fever. Extremely achy and discomfort. -Mild nausea -Intense dull headache -Injection site muscle pain -By 48 hours after injection, symptoms heavily subsided. Lethargy and fatigue remained until 72 hours. No symptoms by 96.
32 2021-04-07 feeling hot Approximately 9 days after injection in left arm, started experiencing symptoms in right armpit cons... Read more
Approximately 9 days after injection in left arm, started experiencing symptoms in right armpit consistent with swollen lymph nodes including: intermittent sharp stinging pain similar to ingrown hair or inflamed hair follicle, as well redness and dull pain upon palpation. Over several days, swelling has increased significantly and pain has increased a little as well. Today, 14 days after injection in left arm, starting to experience onset of lymph node swelling in left armpit as well. Additionally, starting 9 days after injection, concomitant with lymph node swelling, I believe I have felt slightly fatigued and have felt 1 degree warmer than usual, though not actually feverish. I confirmed a temperature of 98.9F today around 5:45PM, whereas my normal temperature is about 97.7F when measured by the same method.
32 2021-04-08 inability to speak, tremor, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient sat down after vaccine and became dizzy. He laid down and fainted but regained conciousness. He was sweating profusely and could not speak well. This lasted about 10 minutes. BP was measured at 150/71 with a pulse of 71. He drank some gatorade and was monitored for 30 minutes and was able to leave.
32 2021-04-08 numbness Developed a medium size knot where shot was given that was hard and sore to the touch. Then also de... Read more
Developed a medium size knot where shot was given that was hard and sore to the touch. Then also developed the same thing up on my collar bone area (may be a lymph node) that is more sensitive to the touch than my arm. Makes me arm feel somewhat numb and harder to grip at times.
32 2021-04-08 night sweats, feeling hot 2nd shot. Night sweats beginning at 1 or 2 am. Felt very warm. Removed blankets in cold room to achi... Read more
2nd shot. Night sweats beginning at 1 or 2 am. Felt very warm. Removed blankets in cold room to achieve comfort. No medications taken. Returned to sleep comfortably and symptoms had resolved with unknown duration by time I awoke in the morning.
32 2021-04-08 tingling Felt mild itchiness at various parts of my body, starting a few hours after the shot was given. I'm ... Read more
Felt mild itchiness at various parts of my body, starting a few hours after the shot was given. I'm not positive if the itchy feelings began within the first 4 hours after the shot, but I think so. I took an antihistamine before bed that night. The next day I occasionally felt very minor tingling, which I believe was the itchiness diminishing. By the third day the itchiness/tingling was gone. I never developed a rash, hives, or swelling. I spoke with my primary care physician during an unrelated annual physical exam that took place a couple days after the vaccination, and he said it's possible it was a very mild allergic reaction, but in his determination it was nothing to be concerned about or to prevent me from getting the second dose of the Pfizer vaccine 21 days later.
32 2021-04-09 feeling cold Pt was sitting in observation area, became very pale, cool, & nauseated, became diaphoretic. Pt lai... Read more
Pt was sitting in observation area, became very pale, cool, & nauseated, became diaphoretic. Pt laid supine with legs propped up, within 5 minutes, patient skin was pink warm & dry, patient allowed to rest for 30 minutes, sat up slowly, states he felt much better. Offered EMS, patient declined, patient called father to transport home. patient left clinic ambulating independently, smiling, thankful for treatment with father to drive home.
32 2021-04-09 feeling of insects crawling on skin Skin crawling, nerves going out of control, loss of muscle tone. Infections everywhere and cognitive... Read more
Skin crawling, nerves going out of control, loss of muscle tone. Infections everywhere and cognitive problems haven?t been able to complete one task for 2 weeks. Can?t see properly either
32 2021-04-10 feeling hot Within 10 minutes of receiving the vaccine the patient became hot and sweating and passed out. He wa... Read more
Within 10 minutes of receiving the vaccine the patient became hot and sweating and passed out. He was given water, gatorade and crackers and remained seated for about 45 minutes before leaving the pharmacy.
32 2021-04-11 feeling hot pt was in observation room, felt hot, passed out around 13:12, took patient to the recliner lifted ... Read more
pt was in observation room, felt hot, passed out around 13:12, took patient to the recliner lifted legs, ice pack, head back. Patient alert and oriented times 3, bp 126/71, 93 pulse, 97% o2 on room air.
32 2021-04-11 tingling client complained of tingling sensation to left arm after receiving 1st Pizer Covid Vaccine. Client ... Read more
client complained of tingling sensation to left arm after receiving 1st Pizer Covid Vaccine. Client had completed 15 min observation when he informed EMT he was feeling tingling sensation to left arm, upper arm, not radiating. Client asked to stay longer in observation. First vitals at 1336: blood pressure 120/78, pulse 66, oxygen 97%. Alert and oriented, no other complaints. At 1344 PHN arrived, reassessed client. Alert and oriented. Per client only upper arm tingling sensation, left arm is where he received vaccine. Tingling not worsening or radiating anywhere else. Arm motor and sensory intact. Vitals at 1347: blood pressure 132/76, pulse 83, oxygen 98%. Per client tingling improving. Wanted to go home. ER precautions given. Client left facility at 1350 with steady gait
32 2021-04-11 tremor Patient received the Pfizer COVID vaccine at around 4:50pm and while under observation he began to f... Read more
Patient received the Pfizer COVID vaccine at around 4:50pm and while under observation he began to feel dizzy. He eventually passed out and became unconscious (5:00pm). Unfortunately he hit the ground with his head after he became unconscious. He also appeared to begin shaking while unconscious. He regained consciousness after about 20 seconds and was immediately fully alert. He stated he had no history of losing consciousness in the past. He was then taken to a nearby hospital via ambulance for evaluation and required staples to address the cut. He was discharged from the hospital around 8:00pm.
32 2021-04-12 discomfort Swelling in the neck started a few days after receiving the first dose of the Covid vaccine. Its no... Read more
Swelling in the neck started a few days after receiving the first dose of the Covid vaccine. Its not known if the swelling is related to the vaccine. Medical exam by primary said my thyroid is a bit full. Some post nasal drip as well. Discomfort from the swelling became gradually more significant over several days. Some tightness when swallowing food. At this time of year I typically get allergy symptoms of hay fever (sneezing, itch/watery eyes, etc.) but neck swelling has never been a symptom for me. Started taking Claritin once a day as I usually do this time of year as well.
32 2021-04-12 hot flush, feeling cold Slight headache, fatigue, cold chills, hot flashes, muscle aches.
32 2021-04-12 migraine 3/26: first dose Pfizer 4/6: insane nausea, chills, migraine, body aches, vivid dreams, insomnia 4... Read more
3/26: first dose Pfizer 4/6: insane nausea, chills, migraine, body aches, vivid dreams, insomnia 4/7: severe lower abdominal pain, cough, rash on injection arm
32 2021-04-12 tingling Tingling feeling near back teeth on L side and on L side of throat. No swelling of tongue or throat... Read more
Tingling feeling near back teeth on L side and on L side of throat. No swelling of tongue or throat and no difficulty breathing. Recovering by end of clinic encounter.
32 2021-04-12 unresponsive to stimuli Patient received Pfizer vaccine at 1445, patient walked over to the observation area at 1450 and sta... Read more
Patient received Pfizer vaccine at 1445, patient walked over to the observation area at 1450 and stated he was not feeling well. Nurse noticed the patient was staring off and stopped responding to verbal cues. Patient placed in chair and blood pressure taken, 142/79. Sternal rub performed, no reaction from patient. Palpable pulse felt bilaterally. After 10-12 seconds patient opened his eyes and stated he felt weird. RN asked patient his name and date of birth, both questions were answered appropriately. RN noticed the patient clinched his eyes shut and stopped talking, after about 10-12 more seconds patient opened his eyes and stated he was still feeling weird. Patient placed in wheelchair and taken to infirmary with Sheriff Officer.
32 2021-04-13 tremor Tremors, shaking in the hands, arms, head, torso (for about 40 seconds)., anxiety, nausea, no loss o... Read more
Tremors, shaking in the hands, arms, head, torso (for about 40 seconds)., anxiety, nausea, no loss of consciousness. Paramedics called and the SV and observe him. Leave at 11:10am.
32 2021-04-14 flushing Site: Pain at Injection Site-Mild, Systemic: Fatining/loss of conciousness - otherwise no sysmptoms ... Read more
Site: Pain at Injection Site-Mild, Systemic: Fatining/loss of conciousness - otherwise no sysmptoms of anaphylactic reaction - however pt said that he doesn't respond with that severity to the flu vaccine and was concerned about his reaction to this vaccine which usually only happens with blood-draw-Mild, Systemic: Flushed / Sweating-Mild
32 2021-04-14 pain in extremity Intense pain down left arm and wrist. Joint pain in left arm.
32 2021-04-15 weakness Weakness, feels like passing out. Evaluated by EMS-Cleared
32 2021-04-15 pain in extremity Fever, headache, brain fog, fatigue, arm soreness (right arm), swollen nodes in right arm pit.
32 2021-04-16 cold sweat, feeling cold Client received vaccine, where Health Center was holding a vaccine clinic for staff needing the vacc... Read more
Client received vaccine, where Health Center was holding a vaccine clinic for staff needing the vaccine. Client came in for his first dose of the Pfizer vaccine. He was nervous prior to receiving the vaccine. Stated that he didn't like getting vaccines. He stated that he had seasonal allergies and was on zyrtec or claritin. He did not have any other allergies or history of a serious allergic reaction to food, medications or vaccine components/vaccines. I vaccinated patient, and he went into the observation room with two APRN's for his 15 minute observation. He stayed in the room for 20 minutes per APRN. When he got up to leave, he walked 20 feet and fainted per APRN note. She stated, "he was cold, clammy pale, bradycardic and was difficult to rouse but spoke less than 2 words or none at a time. Blood pressure at 6:10 pm was 90/50, pulse 40, shallow respirations at 10/min. At 6:15 pm blood pressure was 120/60, pulse 70, and respirations at 10/min. At this time EMS arrived and put patient onto the gurney and transported him to Hospital.
32 2021-04-16 pain in extremity, night sweats Radiating soreness/numbness (whole left arm/injection arm), neck/spine pain (similar to arm soreness... Read more
Radiating soreness/numbness (whole left arm/injection arm), neck/spine pain (similar to arm soreness) but 'pricklier', traveling pain/soreness (effected right arm), night sweats, dry throat, 'frog' in throat, sneezing, runny nose, stomach discomfort
32 2021-04-16 unresponsive to stimuli Pt fainted. Staff alerted by customers that someone was laying in floor. We immediately ran out. Pt... Read more
Pt fainted. Staff alerted by customers that someone was laying in floor. We immediately ran out. Pt was laying face door on floor. Pt was tapped, and verbally asked if he could hear us. Initially there was no response. Checked for breathing, then begin checking for pulse, but he came to. He started speaking with us, saying he was feeling light headed, and got up to notify us, but then he couldn't remember the rest. Asked if he had a history of seizures or diabetes and he said no to either. At some point he went out again, briefly. Meanwhile, the tech called 911. He came to again, begin talking with us. At some point he requested water, which we got. After seeping, he wanted to sit up. We asked him to place his back against the wall, if he wanted to. He did so, and after a few seconds said he wanted to lay down again. EMS came. They asked if he wanted to go to the ER which he consented to. They rolled him out on a stretcher.
32 2021-04-17 feeling cold, pain in extremity, burning sensation Once I received the dose my elbow began to hurt. The feeling later continued to my left hand. The el... Read more
Once I received the dose my elbow began to hurt. The feeling later continued to my left hand. The elbow pain now feels of burning and stiff. My left hand has swelled and feeling of joint pain. My left hand also is cold to touch. No discoloration.
32 2021-04-17 feeling hot, flushing c/o facial flushing and feeling hot 5 minutes after vaccine. Refuses transport to ED.139/81,76,97% R... Read more
c/o facial flushing and feeling hot 5 minutes after vaccine. Refuses transport to ED.139/81,76,97% RA 134/90
32 2021-04-18 hot flush Patient received the 1st COVID-19 Vaccine (Pfizer, Lot #: EW0162, expiration date: 07/31/2021) at 10... Read more
Patient received the 1st COVID-19 Vaccine (Pfizer, Lot #: EW0162, expiration date: 07/31/2021) at 10:00. At 10:12 patient ambulated to Medic in the observation area, asking to use the restroom due to complaints of nausea. Patient was advised by Hospital that he would not be able to use the restroom due to his physical presentation of pale, warm, moist skin, pupils becoming greater than or equal to 9 mm, and a look of confusion. Medic attempted to assist the client with ambulation to anti- gravity chair, when the patient?s knees buckled and he was assisted to the floor. Nurse and Nurse responded to assist Medic. Patient lost consciousness and was then assisted into anti-gravity chair and sternal rub applied. Per Medic , patient?s loss of consciousness subsided after 3 seconds and became conscious, alert, and oriented to person, place, time, and event (CAOX4). Patient stated he has ?syncopal episodes every time he has a procedure done that involves needles.? Baseline vitals were obtained by Medic at 1015, while patient was sitting: blood pressure: 98/50, heart rate: 60, respiratory rate: 18, pupils equal and reactive to light at 5 mm. Patient claimed that about 2 minutes status post- vaccine, he began to feel ?lightheaded, nauseous, and had a hot flash. Patient stated he has similar reactions every time. Patient denied chest pain, headache, vomiting, abdominal pain, and blurry vision. Patient was given water to sip on. At 1020, second set of vitals were taken by Medic, while patient was sitting: blood pressure: 90/60, respiratory rate: 16, heart rate: 97, and patient was conscious, alert, and oriented to person, place, time, and event (CAOX4). Patient?s skin was normal color, warm, and dry. Pupils were 3 mm and equal and reactive to light. Patient claimed last oral intake was on 04/15/2021 with minimal fluid intake as well. Patient denied any complaints and claimed he was feeling better. ALS interventions offered by Medic for further evaluation and care, but patient refused. Third set of vitals were obtained by Medic, while patient was standing, at 1030: blood pressure: 118/76, heart rate: 82, respiratory rate: 14, and patient was conscious, alert, and oriented to person, place, time, and event (CAOX4). Patient was negative for orthostatic pressures and was released into the care of his spouse, after waiting in the observation area for about 1 hour. Patient drank a full 12 ounce water bottle and was able to walk out on his own, with a steady gait and in no distress.
32 2021-04-19 hot flush lightheadedness, nauseaus, symptoms worsen when sitting or HOB elevated. Pale, dizzy, hot flashes
32 2021-04-19 tremor Chills, shaking, low grade fever, headache, muscle soreness
32 2021-04-20 feeling hot Fainting; Swelling of arms and hands; Feeling hot; Hives on the face and limbs; Shortness of breath;... Read more
Fainting; Swelling of arms and hands; Feeling hot; Hives on the face and limbs; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 32 years of age), dose 1 via an unspecified route of administration, administered in arm left on 31Mar2021 14:30 (Batch/Lot Number: EW0150) as a single dose for COVID-19 immunisation. Medical history was None. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. He was not diagnosed with Covid-19 prior to vaccination. He has not been tested for covid since the vaccination. He had no allergies to medications, food, or other products. The patient experienced swelling of arms and hands, feeling hot, hives on the face and limbs. He also had shortness of breath and fainting. The events started on 31Mar2021 18:45 with outcome of recovered with sequelae. Therapeutic measures were taken as a result of the events as the patient was administered with IV saline, steroids and antihistamine. The events resulted to Emergency room/department or urgent care. Information on the lot/batch number has been requested.
32 2021-04-20 tremor Fever, chills with uncontrollable shaking, whole body muscle fatigue and soreness, swollen lymph nod... Read more
Fever, chills with uncontrollable shaking, whole body muscle fatigue and soreness, swollen lymph node with extreme pain. On 4/16/21 the pain from my left armpit lymph node almost made me vomit. Swelling has persisted through today 4/20/21. Chills started on 4/15/21 and ended 4/18/21. Fever from 4/15/21 to 4/17/21. Treated with bedrest and ice pack / warm compress.
32 2021-04-21 tingling Joint pain, nauseous, fatigue, body muscle aches, night sweats/chills, headache, and tingling over b... Read more
Joint pain, nauseous, fatigue, body muscle aches, night sweats/chills, headache, and tingling over body.
32 2021-04-21 tenderness, tingling I think shingles. I have a small patch of red, raised bumps on my right lower back. They don't hurt ... Read more
I think shingles. I have a small patch of red, raised bumps on my right lower back. They don't hurt but I can constantly feel them. They hurt to touch. My front right torso is also slightly tingly in certain spots to touch. Forget this.
32 2021-04-22 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA. Moderate soreness in left upper arm several hours after vaccin... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Moderate soreness in left upper arm several hours after vaccination.
32 2021-04-22 pain in extremity I had a sudden case of hearing loss (felt like my ear was suddenly full of water). I got it around ... Read more
I had a sudden case of hearing loss (felt like my ear was suddenly full of water). I got it around 1 or 2 days after vaccination. ENT specialist diagnosed it as a side effect of the vaccine due to seeing an uptick in similar cases after vaccination. Side effect went away after around 4 days woth no treatment. Went to ER because I had a previous case of SSHL and was afraid this was the same thing. Also had minor arm pain in both doses.
32 2021-04-22 seizure Shortly after receiving the vaccine patient passed out on the floor and was seizing for a few second... Read more
Shortly after receiving the vaccine patient passed out on the floor and was seizing for a few seconds then he got up and was doing fine. He was pale but conscious. EMT came checked him out and he was normal. He refused to be transported to the ER. after EMT left patient left on his own.
32 2021-04-23 feeling cold, tenderness Mild fever/chills for approximately 10 hours from the initial time of reaction, body aches for appr... Read more
Mild fever/chills for approximately 10 hours from the initial time of reaction, body aches for approximately 18 hours from time of reaction, lymphoma in the left armpit with noticable swelling and tenderness starting at about 4 hours from initial time of reaction and continuing on to current time, approximately 54 hours from time of vaccination.
32 2021-04-23 pain in extremity, weakness After second shot: Fever, chills, aches, weakness, brain fog, minor arm soreness. Symptoms started a... Read more
After second shot: Fever, chills, aches, weakness, brain fog, minor arm soreness. Symptoms started approximately 6 hours after the vaccine and lasted about 48 hours. Fever reached 102.6 before I took Advil. I took Advil twice to control fever in the 48 hours.
32 2021-04-24 bell's palsy Diagnosed with Bell's Palsy on right side of my face; administration date 02Mar2021/ number 2; admin... Read more
Diagnosed with Bell's Palsy on right side of my face; administration date 02Mar2021/ number 2; administration date 09Mar2021/dose number 1; administration date 02Mar2021/ number 2; administration date 09Mar2021/dose number 1; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration at 32-years, at single dose in right arm on 02Mar2021 (as source reported; pending clarification) at 13:00 (Lot number: unknown) for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Concomitant medications included atenolol, amlodipine and atorvastatin, all taken for an unspecified indication, start and stop date were not reported. The previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) also via an unknown route of administration at 32-years, at single dose in right arm on 09Mar2021 at 08:30 for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with Bell's Palsy on right side of his face on 06Apr2021 06:00. The adverse event resulted in "Doctor or other healthcare professional office/clinic visit". And the patient received treatment with prednisone and valacyclovir for it. The patient was not diagnosed with COVID-19 prior to vaccination. He had Covid test (IDNOW COVID-19 rapid diagnostic test (nucleic acid amplification test NAAT)) post vaccination with type of Nasal Swab on 30Mar2021 with a result of negative. Event outcome was recovering. Information on the lot/batch number has been requested.
32 2021-04-24 night sweats All four nights since the 2nd vaccine shot I?ve got bad night sweats
32 2021-04-25 weakness patient reported rapid heart rate, weakness, dizziness the next morning after the vaccine
32 2021-04-25 numbness, tremor, weakness Fever (101.5) for 18 hours. Light fever (99) until 36 hours after first symptom. Shakes and chills. ... Read more
Fever (101.5) for 18 hours. Light fever (99) until 36 hours after first symptom. Shakes and chills. Achey joints. Flu symptoms and weakness. Sluggish 24 hours. Cutaneous hyperesthesia for 48 hours. Chest pain and odd feeling when taking deep breaths until 04/23. Persistent headache until 04/24 evening. Headache persisted over front left eye and back of head.
32 2021-04-25 tingling About an hour after the second dose, I had the feeling of pins and needles in my left thumb. It was ... Read more
About an hour after the second dose, I had the feeling of pins and needles in my left thumb. It was most severe that day and has improved a little but I have had it now for five days. I also had this same reaction (but didn't realize it was related to vaccine) after the first shot. I believe it only last two days then.
32 2021-04-26 weakness, flushing Syncopal episode approx 7 mins after vaccine administration. Pt reported feeling weak and flushed b... Read more
Syncopal episode approx 7 mins after vaccine administration. Pt reported feeling weak and flushed before syncopal episode and attempted to drink water to alleviate symptoms. PT placed in trendelenburg immediately after episode. Upon regaining consciousness, pt reported continued weakness. Upon assessment in observation unit pt oriented x4 with initial BP of 86/48, HR of 56, SP02 98%, RR 18, lungs CTA. PT observed for approx 1.5 hours and was discharged asymptomatic with negative orthostatics. D/c vitals BP:104/71 , HR:88, SP02:96%, RR:16
32 2021-04-27 feeling cold Woke up sweaty; was cold for about 30 minutes after; Mild tingling in left arm for about a minute af... Read more
Woke up sweaty; was cold for about 30 minutes after; Mild tingling in left arm for about a minute after passing out; Mild numbness in lips for a few minutes after passing out; Passed out 25 mins after receiving vaccination; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 13Apr2021 09:15 (32-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not have covid prior vaccination and not tested for covid post vaccination. The patient passed out 25 mins after receiving vaccination (13Apr2021 09:40). Lasted a few seconds. Woke up sweaty (13Apr2021 09:45), was cold for about 30 minutes after (13Apr2021 09:45). Mild tingling in left arm for about a minute after passing out (13Apr2021 09:45). Mild numbness in lips for a few minutes after passing out (13Apr2021 09:45). Patient had no treatment for events. The outcome of the event passed out 25 mins after receiving vaccination and mild numbness in lips for a few minutes after passing out was recovered on 13Apr2021, woke up sweaty was recovering, was cold for about 30 minutes after was recovered on 13Apr2021 10:15, mild tingling in left arm for about a minute after passing out was recovered on 13Apr2021 09:46.
32 2021-04-27 numbness, tingling, discomfort Severe pain in arms, hands, legs and abdomen. Pain is numbness and tingling in nature. Pain is worse... Read more
Severe pain in arms, hands, legs and abdomen. Pain is numbness and tingling in nature. Pain is worse in right arm and leg. Very tired and unable to do much. Bedridden state for most of last 19 days. Breathing is deeper and heavier than normal. Occasional dizziness, Headache and nausea.
32 2021-04-27 pain in extremity sore arm 1 day, 102 degree fever for 2 days, fatigue 2 days, dizziness 2 days, headache 2 days, diar... Read more
sore arm 1 day, 102 degree fever for 2 days, fatigue 2 days, dizziness 2 days, headache 2 days, diarrhea 2 days, nausea 2 days
32 2021-04-27 seizure Otherwise healthy patient with no past medical history presents to the ED after having a witnessed s... Read more
Otherwise healthy patient with no past medical history presents to the ED after having a witnessed seizure. Patient was initially confused and only A&O x 2 for EMS. Improved back to baseline while in the ED.
32 2021-04-27 sensory loss, facial paralysis Initially he was diagnosed with Bell's palsy/face drooling; did not have a knee reflex or any feelin... Read more
Initially he was diagnosed with Bell's palsy/face drooling; did not have a knee reflex or any feeling in his hands; did not have a knee reflex or any feeling in his hands; severe muscle pain all over his body to the extent he can't move; severe muscle pain all over his body to the extent he can't move; This is a spontaneous report from a contactable pharmacist. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 06Mar2021 09:45 (lot number: EN6205) at the age of 32 years old, as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medication included salbutamol (ALBUTEROL HFA) taken for an unspecified indication, start and stop date were not reported. Initially the patient was diagnosed with Bell's palsy, his diagnosis was changed to rare reaction to a vaccine as per ER report in the hospital. They changed the diagnosis because it was not only his face drooping (reported as drooling) but he did not have a knee reflex or any feeling in his hands, and severe muscle pain all over his body to the extent he can't move. At the hospital they excluded Lyme disease by blood work and stroke and spinal infection by spinal tapping. Then he was discharged. All events occurred on 12Mar2021 at 09:00 AM. AEs resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (COVID-19 PCR test): negative on 13Mar2021; and on unspecified date, blood work which excluded Lyme disease and stroke and spinal tapping which excluded spinal infection. Corticosteroid was given as treatment for the events. The patient has not recovered from the events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and an implied temporal association, the reported events are considered 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
32 2021-04-28 discomfort Morning of April 29 ...severe joint point unlike normal related to chronic conditions. Knees and hip... Read more
Morning of April 29 ...severe joint point unlike normal related to chronic conditions. Knees and hips of both legs felt and appeared to be swollen. Mobility was limited due to discomfort. Treated with 800 MG OTC ibuprofen 1x and later in evening treated with 1,000 MG Acetaminophen. Pain got to be enough that 1 5 mg Oxycontin was taken around 9pm.
32 2021-04-28 feeling hot Within 10 minutes of receiving the immunization the patient felt hot, and pain down the back of his ... Read more
Within 10 minutes of receiving the immunization the patient felt hot, and pain down the back of his head and neck. He stated his chest felt somewhat heavy off and on. He did not have labored breathing. He was given cold compresses, blood pressure was monitored and 50mg of oral benadryl was given.
32 2021-04-28 feeling hot Chest Pain/warmth
32 2021-04-29 bell's palsy Bell?s palsy
32 2021-05-02 flushing Reaction: Vasovagal response; flushing; loss of consciousness; Tachycardia; nausea; vomiting.
32 2021-05-02 tremor Shakes, dizziness, hives(mild), itchiness -- took benadryl
32 2021-05-03 cold sweat patient received Pfizer vaccine and within 5 minutes of administration had a syncopal episode while ... Read more
patient received Pfizer vaccine and within 5 minutes of administration had a syncopal episode while seated. Patient was diaphoretic and clammy during monitoring period. Vitals 147/87, HR 50, Spo2 100%. Patient reports prior syncopal episodes during blood draws and acupuncture as stated by girlfriend. Was sent to to Urgent care onsite for further monitoring.
32 2021-05-04 feeling of body temperature change This is a spontaneous report from a contactable consumer (Patient) reported himself. A 32-year-old m... Read more
This is a spontaneous report from a contactable consumer (Patient) reported himself. A 32-year-old male patient received bnt162b2 (Pfizer- Biontech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 17Apr2021 19:00 at 32 years old (Lot number: EW0170) at single dose for covid-19 immunization. Medical history was none, his mom had high blood pressure. The patient's concomitant medications were none. No vaccines were administered on the same date or within 4 weeks prior to vaccination. Caller stated he received the first dose of the Pfizer covid 19 vaccine on Saturday, 17Apr2021. Caller reported that 24 hours later on 18Apr2021 around 1830 to 1900, he felt pressure in the back of his head saying it was very subtle and short lived. He had pressure on back of his head behind his left ear that got progressively worse. The pressure started Sunday evening and progressed a little on Monday. It is the worst today. Caller stated that on Monday (19Apr2021) it progressed to throbbing shooting pains. Caller stated that today (20Apr2021) it is pressure or shooting pains and trouble controlling his temperature stating he went from freezing to hot to freezing to hot and headaches. Caller stated it was not consistent. If it is no pain it is just pressure. Caller stated it was on the left side in the back and occasionally came to the front noting nothing on the right side. Caller reported the injection was on the left side. Caller asked has this been reported before, is this normal, should he get it checked out. Caller also stated that he was not feeling well, mentioned his stomach and flu like symptoms on20Apr2021. It threw off his equilibrium. He felt better sitting or laying. About treatment, he just took an ibuprofen yesterday one time for pain. Caller indicated that the pain had worsened.
32 2021-05-04 pain in extremity headache; feel fatigued/super worn out; pretty lethargic/Lethargic as all get out; kind of almost fl... Read more
headache; feel fatigued/super worn out; pretty lethargic/Lethargic as all get out; kind of almost flu-like feeling; arm pain/soreness like "someone punching me in the arm."/arm hurt; Not feeling too good; This is a spontaneous report from a contactable consumer (patient). A contactable 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 32-year-old, on 15Apr2021 at single dose for COVID-19 immunization. Medical history included COVID (Patient had COVID probably within the first few months of COVID being a thing, so that was a while ago). Concomitant medication was not reported. patient received his first Pfizer Covid vaccine dose on 15Apr2021. The following day (16Apr2021) he experienced arm pain/soreness like "someone punching me in the arm." On 18Apr2021 he states he started to feel fatigued, "super worn out", and a headache (19Apr2021). Patient asked if it was normal to experience. He is not feeling too good and doesn't know if that is from the Pfizer Covid-19 Vaccine. Caller's wife got the Moderna shot and caller got the Pfizer Covid-19 Vaccine shot on 15Apr2021. It seemed like his arm hurt on Friday. Saturday it seemed like he was alright. Sunday (18Apr2021) he felt pretty lethargic and kind of almost flu-like feeling, today (19Apr2021) just severe headache and just lethargic as all get out, walking to refrigerator is kind of a task. He was wondering, he heard of like the day after, but if it is a normal thing to have these events a few days after the Pfizer Covid-19 Vaccine. He does not feel like he needs to be rushed to the hospital. Outcome of arm pain was recovered on 17Apr2021 and outcome of other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
32 2021-05-05 muscle spasms, muscle twitching Immediate and continuous cramping/twitching pain in right shoulder. Shoulder now appears permanently... Read more
Immediate and continuous cramping/twitching pain in right shoulder. Shoulder now appears permanently indented. Trouble sleeping and increased pain when exercising.
32 2021-05-05 seizure Felt flushed and dizzy within minutes after receiving vaccine, and started convulsing. Later that ev... Read more
Felt flushed and dizzy within minutes after receiving vaccine, and started convulsing. Later that evening on 5/1 started convulsing again and then twice more. Went to ER to get evaluated by a neurologist who believed he had vasovagal convulsions. Has not had a convulsion since but has had feelings that he might and has steady HA's and feeling faint.
32 2021-05-06 flushing Flushing/sweatiness, dizziness. Vitals wnl. Lack of eating/drinking > 4 h. Given crackers, juice, an... Read more
Flushing/sweatiness, dizziness. Vitals wnl. Lack of eating/drinking > 4 h. Given crackers, juice, and water.
32 2021-05-07 pain in extremity Shortness of breath with slight chest pressure Soreness in arm
32 2021-05-08 flushing Flushing/sweatiness, dizziness. Vitals . Lack of eating/drinking > 4 h. Given crackers, juice, and w... Read more
Flushing/sweatiness, dizziness. Vitals . Lack of eating/drinking > 4 h. Given crackers, juice, and water.
32 2021-05-09 feeling of body temperature change I got my second Pfizer COVID-19 vaccine shot on 5/5 at 1:30PM and woke up on 05/08 at 04:30AM in ext... Read more
I got my second Pfizer COVID-19 vaccine shot on 5/5 at 1:30PM and woke up on 05/08 at 04:30AM in extreme abdominal pain. I was nauseous, had hot and cold flashes, and vomited. The pain eventually moved to my lower right abdominal quadrant and I decided to go the ER at around 11:00AM. I was diagnosed with acute appendicitis and had my appendix removed at about 4PM that same day. I was sent home Sunday at around 11:00AM.
32 2021-05-09 numbness Numb leg.
32 2021-05-10 bell's palsy Bell's Palsy about 2 weeks after vaccine administration. Symptoms are improving today.
32 2021-05-10 tremor had severe body shakes as if subjected to freezing temperatures for approx. 2 hours from 03:00 AM to... Read more
had severe body shakes as if subjected to freezing temperatures for approx. 2 hours from 03:00 AM to 05:00AM with body temperature at 98.5 degrees farenheit and shaking stopped at 05:00 and body temperature was 101.7 degrees farenheit. Throughout the day, body temperature ranged from 98.7 degrees farenheit to 101.9 degrees farenheit. There was some slight body aches as well. By 05/09/2021 side effects went away,\.
32 2021-05-11 burning sensation Patient reported face burning, throatt feeling dry and "taste weird" BP 143/85, HR 74, RR 22, O2 Sat... Read more
Patient reported face burning, throatt feeling dry and "taste weird" BP 143/85, HR 74, RR 22, O2 Sat 100%; MD consulted & recommended J&J on 6/8/21. Pt felt better & was discharged.
32 2021-05-11 facial paralysis, bell's palsy Bells Palsy with paralysis on left side of face
32 2021-05-11 numbness Patient complained of numbness in left leg. EMT called. Assessment done. Vital signs stable. No fu... Read more
Patient complained of numbness in left leg. EMT called. Assessment done. Vital signs stable. No further treatment needed.
32 2021-05-11 tingling, numbness Per pt, 2 hours after receiving 2nd dose of vaccine began to experience headache, numbness and tingl... Read more
Per pt, 2 hours after receiving 2nd dose of vaccine began to experience headache, numbness and tingling to face. Vaciine administered at Clinic
32 2021-05-11 seizure RN administered Pfizer vaccination (2nd dose) approximately 11:06am to client via drive through. Wh... Read more
RN administered Pfizer vaccination (2nd dose) approximately 11:06am to client via drive through. While RN was logging passenger of same vehicle, approximately 11:08am, passenger yelled out for help. RN called for MEDIC. 11:08-11:14 Client became alert, AO x3 11:16 MEDIC arrived on scene
32 2021-05-12 weakness Fatigue, headache, tiredness, dizziness and weakness, chills, muscle pain, feeling unwell, nausea
32 2021-05-12 involuntary muscle movements PATIENT REQUESTED TO BE VACCINATED BY FIRST DOSE OF PFIZER BRAND VACCINE FOR COVID 19. VACCINATION H... Read more
PATIENT REQUESTED TO BE VACCINATED BY FIRST DOSE OF PFIZER BRAND VACCINE FOR COVID 19. VACCINATION HAPPENED AT AROUND 9:39 PM PST. FEW MINUTES AFTER VACCINATION, PATIENT REPORTED FEELING DIZZY. IMMEDIATELY AFTER THAT, HIS BODY STARTED TO EXPERIENCE JERKINGS AND HIS EYES SEEM TO POP OUT. THIS LASTED FOR AROUND 30 SECONDS. PATIENT REGAINED NORMAL STATE OF CONSCIOUSNESS AFTER THOSE 30 SECONDS. HE MENTIONED FEELING FINE. 911 WAS CALLED. PARAMEDICS CAME AT AROUND 10:40 PM. PATIENT WAS CLEARED TO BE NORMAL BY THEM AFTER WHICH HE LEFT THE FACILITY
32 2021-05-12 tremor Fevor of 99.9 degrees, shakes, headache, dizziness
32 2021-05-13 pain in extremity Arm sourness for one and a half days. 'Punctured' feeling for as long, distinct from general sourne... Read more
Arm sourness for one and a half days. 'Punctured' feeling for as long, distinct from general sourness. Dry mouth starting almost immediately from time of shot till one day later. Tiredness for about 20 hours, despite sleeping for 6 hours twice. Fatigue/drowsiness for about 30 hours. Loss of apatite for about 32 hours (about 1400 calories consumed with meals left mostly unfinished). Unusually high depression and generalized anxiety (not mostly about shot side-affects, but mostly existential) for about 28 hours. Runny nose for about 8 hours. Elevated sneezing for about 4 hours.
32 2021-05-14 weakness Fever 104°F, Weakness, Achiness, and headache for about 24 hours
32 2021-05-14 pain in extremity Same day - fever; pain in injection site; mild pain in legs and back; lethargy Next day - extreme fa... Read more
Same day - fever; pain in injection site; mild pain in legs and back; lethargy Next day - extreme fatigue; muscular and joint pain throughout body; headache; worse fever and reddening of face; difficulty moving and walking due to pain; general cloudy feeling; fever delirium 2-3 days after - nausea
32 2021-05-15 flushing About 10 minutes after administration of vaccine, I noticed pain in my chest, similar to a previous ... Read more
About 10 minutes after administration of vaccine, I noticed pain in my chest, similar to a previous heart attack. Within another 5 minutes, I felt lightheaded and my face was flushed. I was given water, had pulse ox, heart rate, and blood pressure checked while sitting. All in all, kept a further 30 minutes for testing/observation.
32 2021-05-15 tingling, burning sensation Burning/Tingling Sensation in both legs, from the kneecaps to the feet.
32 2021-05-17 cold sweat Pt c/o anxious, dizziness, and nausea 5 minutes after his second dose of COVID vaccine. He became p... Read more
Pt c/o anxious, dizziness, and nausea 5 minutes after his second dose of COVID vaccine. He became pale, diaphoretic with clammy skin. assisted patient lay down on yoga met with legs elevated. His vital signs are: BP 125/84; P 87; R 18; O2 saturation 100%. patient felt better 2 to 3 minutes after lay supine. Assisted patient back to chair. Continue to monitor patient until all symptom subsided. Patient left observation area with wife at 07:45pm.
32 2021-05-17 pain in extremity Sore arm at first; fever at 102.0 F; chills; body aches; mild headache; This is a spontaneous report... Read more
Sore arm at first; fever at 102.0 F; chills; body aches; mild headache; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El3247) in the left arm, at single dose, on 11Feb2021 at 02:00 PM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history was unknown. The patient previously received, on 21Jan2021 at 02:00 PM, the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El3247) in the left arm, at single dose, for COVID-19 immunisation. Known allergies to cephalosporin was reported. Concomitant medications included esomeprazole sodium (NEXIUM) and fexofenadine hydrochloride (ALLEGRA). On 11Feb2021, at 07:00 PM, the patient experienced sore arm at first. Then developed fever, chills, body aches and mild headache. Fever, chills and body ache lasted approximately 12 hours. Highest temperature during fever was 102.0 Fahrenheit. No treatment was received. COVID was not tested post vaccination. The patient recovered from the events. No follow-up attempts are possible. No further information is expected.
32 2021-05-18 pain in extremity Arm pain for 2 days on a 7 of 10 pain scale. Swollen lymph nodes under the arm where vaccine was ad... Read more
Arm pain for 2 days on a 7 of 10 pain scale. Swollen lymph nodes under the arm where vaccine was administer
32 2021-05-18 seizure Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Additional Details: Patient refuse... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Additional Details: Patient refused medical services after pharmacy staff notified 911 about incident. Patient reported a history of fainiting after vaccine was administered.
32 2021-05-19 weakness Very bad headache, loss of appetite, no energy, very sharp low back pains. all joints sore. was basi... Read more
Very bad headache, loss of appetite, no energy, very sharp low back pains. all joints sore. was basically in bed all day the next day
32 2021-05-19 weakness covid vaccine given 5/5/2021: pt experiencing mild dizziness and weakness. Patient denies any urgent... Read more
covid vaccine given 5/5/2021: pt experiencing mild dizziness and weakness. Patient denies any urgent concern at this time. pt to see PCP (external to system)
32 2021-05-19 tingling, weakness, pain in extremity Patient developed low grade fever 18 hours after vaccine associated with bilateral hand and foot par... Read more
Patient developed low grade fever 18 hours after vaccine associated with bilateral hand and foot parthesias associated with reported loss of grip strength as well. Resolved by approx 72 hours after vaccine except for some residual heel pain.
32 2021-05-20 unresponsive to stimuli After administering the shot I was explaining to wait for 15 minutes, as we were speaking patient ... Read more
After administering the shot I was explaining to wait for 15 minutes, as we were speaking patient stated he was feeling light headed then he slumped forward and became unresponsive for a few seconds during that period he urinated on the chair and floor I had a customer get the pharmacist and the patients wife came to him. The patient remained shaky, as we retrieved a towel and some water for him. The patient remained sitting and resting for about 20 mins during this time we offered to call 911 to which the patients wife stated that something similar to this happened before and declined the call to 911.
32 2021-05-21 pain in extremity, tremor I felt very lightheaded and woozy roughly 5 minutes after injection. I was found passed out on the b... Read more
I felt very lightheaded and woozy roughly 5 minutes after injection. I was found passed out on the bathroom floor shortly after, with no recollection of entering the bathroom. It was estimated I was out for a couple minutes. I personally wondered if it caused blood pressure to drop, but I had no way to test it and was more focused on sitting up at the time. I stayed in the waiting area until I was confident I was able to walk on my own. A second wave, though less intense, happened roughly 30-45 minutes after the first. I left the store after 2 hours with fatigue, arm pain, and the hand of the opposite arm shaking on its own. The hand stopped shaking roughly 3 hours after the injection. Fatigue was mostly gone in a day. I could not raise my arm above chest height without pain the 1st day. Today is day two and I can raise it up properly again with mild stiffness and slight twinges of pain.
32 2021-05-22 tingling 32 year old male complaint of feeling lighted headed, vision distortion, sensation of fluid in both ... Read more
32 year old male complaint of feeling lighted headed, vision distortion, sensation of fluid in both ears, and nasal tingling. skin is cool to touch and pale in color. Writer gave water. After drinking water patient felt better. Patient reported no longer having vision distortion. Wife and patient stated do not need EMT and stated going to drive home.
32 2021-05-23 flushing, unresponsive to stimuli, tremor Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Letha... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Shakiness-Medium
32 2021-05-23 flushing Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Di... Read more
Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hearing and vision difficulty-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Vitals were normal after 30 minutes
32 2021-05-24 pain in extremity, numbness The patient began to vomit within 10 minutes of receiving his vaccine . He was also having numbness ... Read more
The patient began to vomit within 10 minutes of receiving his vaccine . He was also having numbness in his left hand. I sat with the patient in the consultation room for 20 minutes, until he became more calm. I offered him some water and I took his blood pressure every 5 minutes. It was initially 154/105 and eventually decreased to 140/90. His heart rate was normal and he had no shortness of breath or signs of any rash. He threw up twice. I offered to call ems for him if he wanted but he declined. Once his blood pressure decreased he said that he felt better and sat in the pharmacy waiting area until he felt completely better. I called him 30 minutes after his departure from the pharmacy to make sure he got home safe and he was thankful for the call. I did advise him to contact his PCP if the numbness in his hand worsens or does not get better. I also told him to seek medical help if he gets any shortness of breath, rash or other unusual symptoms.
32 2021-05-25 weakness Heart issues, weakness and dizziness. I went to a family doctor and after blood test, I need to see ... Read more
Heart issues, weakness and dizziness. I went to a family doctor and after blood test, I need to see a cardiologist urgently because my blood test found my CK in 742H where the scale is between 31-336. I?m young and athletic and never had a condition in my life, but all these started two weeks after the vaccination.
32 2021-05-25 pain in extremity His arm was sore; Felt fatigued; Him and his wife both got their 1st shot of the Pfizer covid vaccin... Read more
His arm was sore; Felt fatigued; Him and his wife both got their 1st shot of the Pfizer covid vaccine last week at pharmacy/they got a call from pharmacy that it was not stored at the right temperature; Him and his wife both got their 1st shot of the Pfizer covid vaccine last week at pharmacy/they got a call from pharmacy that it was not stored at the right temperature; This is a spontaneous report from a contactable consumer. Patient reported about him and his wife. This is report 1 of 2. A 32-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and expiration date: Unknown), via an unspecified route of administration on 07Mar2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received vaccine which was not stored at the right temperature and patient stated he was given a bad vaccine and offered a new appointment for a good vaccine. Patient reported his arm was sore, felt fatigued for 2 days, but now although him and his wife feel okay. The outcome of arm was sore, felt fatigued was recovered and other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
32 2021-05-26 feeling hot, pain in extremity, discomfort I received the COVID-19 vaccine at 9:30 am from vaccination clinic. I had just recovered from COVID-... Read more
I received the COVID-19 vaccine at 9:30 am from vaccination clinic. I had just recovered from COVID-19 about two and a half weeks prior. I had no immediate reaction. I worked the entire day with no adverse effects other than a sore arm, which I expected. Later in the day at about 7:45 pm I went for a 6 mile run and got home at approximately 8:49 pm. Within half an hour of getting home, I quickly became feverish. The fever continued to rise until I was extremely hot, and hotter than I can ever remember as an adult or child. I did not have access to a thermometer so I cannot reliably report what the temperature was but I am estimating 103. It felt like every part of my body, including my legs, was hot to the touch. By 1 am I had serious chills and was shivering under winter blankets despite an outdoor temperature of 70-80. In addition, I had an extremely elevated heart rate and chest pain. I also had generalized muscle aches all over my body. I did not sleep at all that night. The fever began to slowly dissipate early in the morning but the elevated heart rate continued for approximately 24 hours. The discomfort resulting from my elevated heart rate was substantial and alarming enough that I sought advice from my primary care physician after a nurse at my Occupational Health clinic suggested potentially getting an ECG. Ultimately, by Thursday morning, the symptoms had decreased and I declined any follow up. However, this was the single worst reaction I've ever had to any vaccine and the single worst fever I've ever experienced as an adult or in my memory as a child. Although I am aware that people who have already had COVID-19 tend to have worse reactions to the first COVID vaccine, I am filing this report primarily because of my concern that exercise may trigger an especially severe reaction.
32 2021-05-26 numbness In the morning of May 2nd I was driving and I felt my heart rate increasing lasted about 30 minutes ... Read more
In the morning of May 2nd I was driving and I felt my heart rate increasing lasted about 30 minutes to an hour. I ended up going to the ER and I was diagnosed with sinus tachycardia, I stayed overnight. After that event I developed a cognitive fog and a sensation of numbness on the left side of my head like someone is pulling the skin on my face ever so slightly. I also developed a sense of imbalance like I am in a boat for an extended period of time. These feelings remained constant and I noticed that they were getting better by May 19th. At 6 am on May 19th I walk up to the feeling of my heart pounding and my heart rate increasing, I measured my pulse on my watch and it was around 150 bpm average. This event lasted about 5 minutes and went away. On May 19th around 10 pm I was in the shower and my heart rate increase again and I felt a tickling sensation on the left side of my chest when I was breathing in. I ended up going to the ER gain and stayed overnight. May 26th I felt the sensations of fogginess and just feeling off cognitively. May 27th I woke up rested without fogginess and after a morning walk with my dog I felt my heart increasing. This episode lasted about 10-20 minutes and my heart rate was ranging between 120-150 bpm. My stools from April 20th till May 26th have been lighter in color yellowish and soft, when I consumed vegetables I could see specs of them in my stools like they were not fully processed. May 27th was the first day where my stool color was brown but still soft.
32 2021-05-26 seizure 33 year old healthy man presented with seizure to Hospital ER on 5/7/2021. He required intubation. C... Read more
33 year old healthy man presented with seizure to Hospital ER on 5/7/2021. He required intubation. CT scan and MRI of brain showed dural venous sinus thrombosis along the anterior to mid aspects of the sagittal sinus. CBC was normal at presentation with WBC 13.9, HGB 16.1 and PLT 367k. He was admitted on unfractionated heparin. Repeat platelet count on 5/8/2021 was 153k. HIPA was negative. Patient was extubated and continued to improve. He was put on warfarin and sent home. He has some mild personality change in the immediate weeks of discharge. Hypercoagulable workup had normal Prot S & C activity, normal ATIII activity. The Factor V Leiden and Prothrombin Gene were negative. The homocysteine level was elevated at 16.3.
32 2021-05-27 grand mal seizure Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient brought in by ambulance to e... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient brought in by ambulance to emergency department (ED) for generalized tonic-clonic seizures. Patient experienced first seizure and treated, evaluated, and released from ED at another facility. Patient experienced another seizure at home and brought to this facility. Patient experienced a third seizure in the ED, antiepileptic medication was initiated, patient was admitted then discharged the next day stable on antiepileptic medication and follow-up in place. On subsequent follow-up visit with primary care patient reported no seizures but back pain. Found to have a thoracic compression fracture from seizures prior to hospital admission. On neurology follow-up continues to be seizure-free and compliant with antiepileptic medication. Diagnosed with focal epilepsy and will continue to be followed by outpatient neurology.
32 2021-05-27 seizure, feeling hot Patient reported tunnel vision and subsequently passed out, seized for 5 seconds, and then regained ... Read more
Patient reported tunnel vision and subsequently passed out, seized for 5 seconds, and then regained consciousness. Patient afterwards reported having a history of this type of reaction to vaccines, tattoos, and dental work. Patient became very warm, received water, and an ice pack. Patient was cooled down and left 30 minutes after the event.
32 2021-05-28 tremor nausea; Subjective fever; chills; shaking; significant muscle and joint pain; significant muscle and... Read more
nausea; Subjective fever; chills; shaking; significant muscle and joint pain; significant muscle and joint pain; fatigue; headache; This is a spontaneous report from a non-contactable Physician (patient) reported for himself. This 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 28Jan2021 at 09:00 am (age at vaccination was 32 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient did not have any medical history. Concomitant medications patient received within 2 weeks of vaccination included ibuprofen (MOTRIN [IBUPROFEN]), acetylsalicylic acid, caffeine, salicylamide (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;SALICYLAMIDE]) as needed. The patient previously took augmentin [amoxicillin;clavulanic acid] and had allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 07Jan2021 at 11:00 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 Hospital. On an unknown date, the patient experienced subjective fever, chills, shaking, significant muscle and joint pain, fatigue, headache, nausea which started 18 hours after injection. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.
32 2021-05-31 bell's palsy Bell's Palsy started on 5/18/21. He was then started on prednisone and antiviral medication.
32 2021-05-31 pain in extremity, numbness Right arm numbness, swelling, pain for 4 days. Fatigue for 2-3 days.
32 2021-06-01 weakness weak; Low kidney function; Low platelets/platelets numbers are low; kidney numbers are low; Fever up... Read more
weak; Low kidney function; Low platelets/platelets numbers are low; kidney numbers are low; Fever up to 102.5F; This is a spontaneous report from a contactable consumer. A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 08:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. Patient previously received the first dose of BNT162B2 for covid-19 immunization. There were no concomitant medications. Consumer is the sister of the patient that after getting the second dose of the Pfizer covid vaccine is experiencing after several days fever up to 102.5F on 04May2021, low platelets and low kidney function. her brother who is too weak right now to call. He got his second vaccine and right now it will be 2 weeks ago, he got it on 03May2021, he had the COVID virus in Nov, it has been 2 weeks since the second dose as of tomorrow and he has had 102 degree fever the whole time throughout the day and night. She is trying to understand if this is something to be concerned about. He had blood work done and his platelets numbers are low and his kidney numbers are low and she is looking for peace of mind of if this is commonly reported adverse event or maybe the steps to be taken. She says she works for (Company) so she familiar with having to report adverse events. Her brother is also awaiting chest x-ray results, he was negative for mono, flu, and negative for COVID.The patient underwent lab tests and procedures which included body temperature: 102.5 fahrenheit on 04May2021, chest x-ray: unknown results, influenza virus test: negative, investigation: low on 13May2021, mononucleosis heterophile test: negative, platelet count: low on 13May2021, sars-cov-2 test: negative. Outcome of events was unknown. Information on the lot/batch number has been requested.
32 2021-06-01 feeling hot Became unconscious and collapsed onto the floor. Unconscious for approximately 3 minutes. After wa... Read more
Became unconscious and collapsed onto the floor. Unconscious for approximately 3 minutes. After waking, patient reported feeling hot.
32 2021-06-01 pain in extremity He cant keep anything down and he keeps running to the toilet; Throwing up; Deathly ill; Gave him na... Read more
He cant keep anything down and he keeps running to the toilet; Throwing up; Deathly ill; Gave him nausea pills but they're not helping; Sore arm; Cant even keep soup down/still cannot eat.; Can't lift arms and legs; Start passing out; Sick; Progressed into flu like symptoms 3-4 days after the shot; This is a spontaneous report from a contactable consumer reported for her son. A 32 year old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05May2021 at age of 32 year old (Batch/Lot Number: EM4965) at 2nd dose, single for COVID-19 immunisation. Medical history included ongoing shellfish allergy started in childhood. None family medical history included. Concomitant medications were none. None vaccines administered on same date with the Pfizer vaccine. None other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation, after he had the first shot, he was fine other than a sore arm. He had the second dose on 05May2021 and it started with a sore arm and then progressed into flu like symptoms 3-4 days after the shot on May2021. He was actually sick on 05May2021. He says that he cannot keep anything down and he keeps running to the toilet. He has been missing work and he never misses work. He cannot even keep soup down. He checked himself into the hospital and they released him yesterday after IV fluids and they gave him nausea pills but they're not helping. If he cannot keep anything down then he's going to start passing out on 05May2021. He went and had a Covid test a week ago to make sure he didn't have Covid. States he has been throwing up on 05May2021 and deathly ill on 05May2021. States that it started the first couple of days like flu like symptoms that have kept getting worse. States he can't lift arms and legs on 05May2021. She says at the hospital yesterday they gave him anti-nausea pills and hydration. States he still cannot eat on 05May2021. His symptoms began the evening of 05May2021. They have continued to worsen. She wanted him to go be seen at Urgent Care about a week ago; but he just went and got a Covid test. States he has been missing work ever since 05May2021. States that he finally couldn't stand it anymore and checked himself into the hospital yesterday. She says he was admitted on 16May2021, but they discharged him in the evening on 16May2021. AEs require a visit to emergency room. No physician office. He ran tests in the hospital, like blood tests. No specifics or results provided. Outcome of the event cant keep anything down and he keeps running to the toilet, throwing up, gave him nausea pills but they're not helping, sore arm was unknown. Outcome of other events was unknown. Information about Lot/ batch number has been requested
32 2021-06-02 nerve pain, burning sensation, pain in extremity I have been having nerve pain on the right side of my body. I have NEVER in my life had any nerve pa... Read more
I have been having nerve pain on the right side of my body. I have NEVER in my life had any nerve pain what so ever. This week the pain got much more noticeable. My right arm by inside bicep has a pain of burning and itching. My right leg has burning nerve pain in multiple spots. I know my body and this is 100% because of the vaccine. The pain itself is not very bad, but it?s very noticeable. Burning sensation in different parts of my right limbs. Will this go away? I fear getting my second shot and this getting worse. Any advice?
32 2021-06-05 flushing, feeling hot, tingling, flushing, numbness, discomfort, tingling, feeling hot Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, System... Read more
Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Tingling fingertips-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: A couple of minutes after the shot, the patient said he had a sharp neck pain. He sat down and then said he felt hot all over except his arms which were tingling/numb. Patient was clearly very anxious and said he felt "odd," and he asked me to call his wife and appeared to be having a panic attack. It lasted about 10 minutes, and at 13 minutes post vaccine, patient said it had passed. He seemed fine when he left after his 15 minutes and said over and over he did not want me to call an ambulance.
32 2021-06-07 muscle spasms Chest pains, unexplained spasms and pains throughout my body, getting dizzy several times throughout... Read more
Chest pains, unexplained spasms and pains throughout my body, getting dizzy several times throughout the day.
32 2021-06-07 pain in extremity Patient called to office 6/8/2021 and complained of swollen neck, a "weird fuzzy feeling in his face... Read more
Patient called to office 6/8/2021 and complained of swollen neck, a "weird fuzzy feeling in his face and head", and sweats. Per the patient he has been having this feeling since his COVID vaccine 3/2021. Patient told nurse he has been having sweats and arm pain, and heart keeps racing. Patient stated that is cardiologist has said that everything is fine. Patient stated he has also been to the ER and they could not find anything with the tests that were done. He has been to healthcare facility several times. Per information patient received the Pfizer vaccine on 3/13/21.
32 2021-06-08 weakness, slurring Pnt called Saturday 6/6 stating he developed tightness in chest within hours and laryngitis, a stutt... Read more
Pnt called Saturday 6/6 stating he developed tightness in chest within hours and laryngitis, a stutter, hard to articulate thoughts and generally didn't feel well by that evening. I advised to go to ER for evaluation. I followed up on Tues 6/8/21 and he stated the ER said he has inflammation of the heart and lungs but sent him home. Also none of the previous symptoms had resolved and he also has pain in left upper chest, decreased energy and loss of appetite. The patient said he doesn't have a PCP so I advised to go to ER again.
32 2021-06-08 weakness bedridden; extreme nausea; headache; bodyache; stiffness; chest pain; dizzy whenever I try and stand... Read more
bedridden; extreme nausea; headache; bodyache; stiffness; chest pain; dizzy whenever I try and stand/ light headed; can't focus on screen very long without feeling like throwing up; can barely turn neck; bones/joints hurt; bones/joints hurt; no energy; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0191) via unspecified route of administration, administered in arm left on 01Jun2021 at 06:15 (at the age of 32-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included allergy to peanuts and shellfish. Concomitant medication was not reported. The patient previously took bnt162b2 (lot number: EW0185) in arm left on 07May2021 at 07:15 as 1st dose, single dose for COVID-19 immunization and experienced bed ridden and fatigue. No other vaccines within 4 weeks prior to the COVID vaccine. On 02Jun2021 at 10:00 (AM), the patient experienced lightheaded, extreme nausea, physical weakness, headache and body ache. It was reported that the patient also experienced stiffness, chest pain, dizzy on same day. Whenever the patient was trying and stand, could not focus on screen very long without feeling like throwing up, always lightheaded, could barely turn neck, bones and joints hurt and no energy. The patient stated he received full-time care while bedridden first day and a half from his partner and continue to receive care daily as he was not able to accomplish much on his own at this point. The patient also stated he did not know if this was a permanent condition caused by the vaccine nor did he know what the extent of any permanent damage was. This was the worst body he had ever felt. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. Patient was not tested COVID post vaccination. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
32 2021-06-08 weakness Low blood pressure Sweating all the time Loss of energy Dis colored urine All systems are still on... Read more
Low blood pressure Sweating all the time Loss of energy Dis colored urine All systems are still on going I don't have health insurance and no one will see me
32 2021-06-08 numbness complaints of numbness to right lower lip and right cheek
32 2021-06-08 seizure, weakness Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Syste... Read more
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Aprox. 2 min. after vaccine admin., pt. fainted and appeared to have a seizure. Upon regaining consciousness, pt, began sweating and vomited. Pt was confused after the incident. EMS was called and took over care. Pt was taken to local hospital. Outcome of ER visit in not known.
32 2021-06-09 feeling hot, unresponsive to stimuli After receiving the vaccine the patient was instructed to sit at the designated post vaccination are... Read more
After receiving the vaccine the patient was instructed to sit at the designated post vaccination area. As he was sitting in the chair, a few minutes after receiving the vaccine the patient lost consciousness and fell from the chair onto the floor. The patient was unresponsive for a few seconds. When I positioned him in an upward position he regained consciousness and did not remember what happened. The patient had a fast heart rate and was feeling hot, dizzy, and nauseated. He showed no signs of anaphylactic/allergic reaction. Patient admitted he was nervous and anxious about the vaccine and does not like needles. I instructed the patient to remain seated on the floor and gave him an ice pack, water, and told him to take deep breathes. Patient stated he felt better. The store manager and I called 911 to get paramedics to check his vitals. Patient denied to go to emergency room, said he was feeling better. Patient confirmed he lived only a few blocks away and he had someone to drive him. Paramedics cleared the patient and stated all vitals were in normal range. Patient stayed at the pharmacy for 10 more minutes after that with instructions if he felt any symptoms to call his doctor or 911.
32 2021-06-09 pain in extremity Sore at injection spot after 1st shot for about 1 hour. Sore arm from elbow to shoulder from 5 hou... Read more
Sore at injection spot after 1st shot for about 1 hour. Sore arm from elbow to shoulder from 5 hours after 2nd shot. Continued for about 24 hours. site of injection was red and size of a quarter.
32 2021-06-09 pain in extremity I got my second dose of the Covid vaccine on 5-16-21 and my right arm is still sore weeks after and ... Read more
I got my second dose of the Covid vaccine on 5-16-21 and my right arm is still sore weeks after and it has gone away as of today 6-10-21. I can?t lift anything heavy with out it hurting.
32 2021-06-09 tenderness, night sweats slept first day after vaccine began losing appetite slightly no change in bowel by day 3 breathin... Read more
slept first day after vaccine began losing appetite slightly no change in bowel by day 3 breathing was a bit labored chalked it up to regular auto immune response and chest inflammation day 5 night sweats and woke up to wet pillow day 6 fought consciousness after coming home from non strenuous day and was taken to hospital at my resquest. sweaty palms mild headache chest pain and slight tenderness in ribs
32 2021-06-10 weakness Fatigue; light-headed; nausea; physical weakness; headache; body ache; This is a spontaneous report ... Read more
Fatigue; light-headed; nausea; physical weakness; headache; body ache; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 07May2021 07:15 (Batch/Lot Number: EW0185) as a single dose for covid-19 immunization. Medical history included allergy to peanuts and shellfish allergy. The patient's 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, since the vaccination, the patient has not been tested for COVID-19. After the administration of first dose, the patient experienced fatigue lasting from 2 days after dose through receiving 2nd dose, light-headed, nausea, physical weakness, headache and body ache. Following questions of what were caused can't be answered. The patient received full-time care while bedridden first day and a half from his partner and continue to receive care daily as he was not able to accomplish much on his own at this point. He does not know if this was a permanent condition caused by the vaccine nor does he know what the extent of any permanent damage was. This was the worst his body has ever felt. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
32 2021-06-10 pain in extremity Chest pain, shortness of breath, fatigue, leg pain
32 2021-06-10 unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Un... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild
32 2021-06-11 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient received the vaccine, then used the restroom and came back to wait, 5 minutes post vaccine, he fainted. Regained consciousness when his name was called out, was provided soda and ice pack behind neck. Stated seated, then laid down for a few minutes and then seated upright. EMS was called in to ensure no other injuries.
32 2021-06-11 pain in extremity, migraine Dose 1: Zero side effects Dose 2: Fatigue within four hours, migraine headaches to follow periodical... Read more
Dose 1: Zero side effects Dose 2: Fatigue within four hours, migraine headaches to follow periodically for three days, Pain in left shoulder and swelling and redness, Swollen Lymph Node under the armpit, pain followed in shoulder and arm for one week
32 2021-06-13 pain in extremity Severe back and leg pain began after doing daily stretches on 3/26. MRI determined that the minor h... Read more
Severe back and leg pain began after doing daily stretches on 3/26. MRI determined that the minor herniation had ruptured and caused an extrusion. A surgical microdiscectomy was necessary to remove the extrusion.
32 2021-06-14 flushing, tremor, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild, Additional Details: Patient lost conciousness while waiting his 15 minutes after recieving his first Pfizer COVID-19 vaccine. We ran to his aid, and upon arriving at his side we laid him down on the ground. Before we were able to assess his pulse and breathing status he jolted awake and started shaking his arms and kicking his legs. After a few seconds of panic the shaking stopped and he sat upright. EMTs arrived on scene and confirmed his BP and pulse were returning to normal.
32 2021-06-14 tingling I received the first covid vaccination in May 5th and a week or so later started getting tingling in... Read more
I received the first covid vaccination in May 5th and a week or so later started getting tingling in my toes that would come and go. I did not tie it to the vaccine at first as it was not a listed side effect I saw. On 5/26/2021 I received the second shot and the tingling spread to more of my toes, and then into my hands a few days later. After another few days my legs became very weak and I went into the Emergency Room where they diagnosed me with Guillain-Barre and my symptoms continued to worsen where I lost all my reflexes and ability to walk as usual
32 2021-06-15 pain in extremity One week after shot developed burning pain in arm and shoulder. The pain lasted two weeks then went ... Read more
One week after shot developed burning pain in arm and shoulder. The pain lasted two weeks then went away. After the pain subsided weakness in the muscles of the shoulder and arm developed.
32 2021-06-15 unresponsive to stimuli, flushing Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / ... Read more
Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient passed out 3 minutes after receiving vaccine, came to after about 1 minute. EMS called and evaluated patient, patient refused to go to hospital.
32 2021-06-16 migraine Patient was seen by primary care physician and opthamologist. Patient was diagnosed with shingles (a... Read more
Patient was seen by primary care physician and opthamologist. Patient was diagnosed with shingles (also ocular shingles). Patient reported a rash from top of head to eye, and from nose to ear on the right side of the body. He experienced swollen lymph nodes on the right side and eye swelling. He lost half of his vision in the right eye that has still not returned at this time. In addition to the shingles, he experienced an excrutiating mgiraine (10/10 on pain scale) which he described as the worst he has ever experienced. He also expreinced joint pain and fatigue. At this time, he is being treated with a course of valacyclovir.
32 2021-06-16 tremor, feeling cold Body aches. Flu like symptoms .Dizzy and lots of pain. Feeling Cold . Body shaking.
32 2021-06-21 tingling, pain in extremity Extreme fatigue still occurring, tiredness, leg pain/tingling
32 2021-06-24 feeling hot Fever-like feeling, and painful headache.
32 2021-06-24 numbness Left leg numb from the whole left butt cheek down to his knee/ left arm feels kind of numb and a lit... Read more
Left leg numb from the whole left butt cheek down to his knee/ left arm feels kind of numb and a little heavy; Left arm feels kind of numb and a little heavy; Fatigue; Was sleeping a lot; Pain from the shot at the injection site; This is a spontaneous report from a contactable consumer (patient, self-reported). A 32-year-old male patient (age at vaccination: 32 year) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0217 and expiry date was not reported), via an unspecified route of administration, in Deltoid Left (upper arm), on 03Jun2021, as a single dose for COVID-19 immunization at Pharmacy. The patient's medical history included dysautonomia (he was born with it) and herniated disc. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (GOODY'S) (powder for headache or something like that, or back pain powder, in the week or 2 before the vaccine. It was like a pain powder that comes in a little pouch instead of actual pill like Tylenol. No further information provided). There was no family medical history relevant to adverse events. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0182 and expiry date was not reported), via an unspecified route of administration, in Deltoid Left (upper arm), on 14May2021, as a single dose for COVID-19 immunization at Pharmacy and no reaction on previous exposure to vaccine. The patient did not receive any vaccine within 4 weeks prior vaccinations, he had never even had the flus shot before. He had never even had the flu either. Investigation assessment was not done. The patient stated he was calling regarding the Pfizer Covid vaccine. He got the second shot 03Jun2021, about 2 weeks ago. The back side of his left leg was completely numb from the whole left butt cheek down to his knee and it has been since he got the second shot. Also, his left arm felt the same, kind of like he has been holding it over his head for a long time, it felt kind of numb, but not really, but kind of heavy. This probably wasn't a common thing, so he wanted to report it. He had some other side effects, but he wanted to give it a little more time to make sure it didn't go away. The patient's left leg numb from the whole left butt cheek down to his knee which started within the next day or 2 and it hadn't gone away. It felt about the same. It felt like it fell asleep, the whole back side area. It was like holding the arm above the head too long where it loses a little blood. It felt kind of cold and stiff and felt a little heavy. It started around the same time as the numbness in the leg, but it may have taken a little bit to notice because he did have the fatigue and was sleeping a lot the first couple days. That might have been why it took a couple of days to really notice what was going on with his arm. It was after the second dose and lasted a couple of days. It has stayed the same. Numbness was 2 inches higher where he has a herniated disc. The patient's had pain from the shot at the injection site on 03Jun2021, which was normal and went away, the heaviness of the arm was still there and was just right at the injection site. It didn't feel any worse than a tetanus shot. It was kind of a longer needle and all, so he expected that to be normal anyway. The soreness went away the second day. The adverse events did not require a visit to emergency room or physician office. No relevant tests were performed. The patient did not receive any treatment. When asked if he had any other concerns, patient stated, not unless Pfizer was going to help with the copay for going to the doctor and clarified that this was not an actual request, says he was joking. Outcome of the event pain from the shot at the injection site was recovered on 04Jun2021 and for the events fatigue and was sleeping a lot it was reported as unknown and for all other events, it was not recovered. Information on the lot/ batch number has been requested.
32 2021-06-24 pain in extremity Severe pain in knuckle joint which causes swelling and pain in index finger on right hand. The pain... Read more
Severe pain in knuckle joint which causes swelling and pain in index finger on right hand. The pain is still ongoing, been almost 4 weeks. Not getting better even with ibuprofen. Loss of strength and mobility in finger, hard to use pencil or chopsticks. Never had injury there before, only happened after second dose of vaccine.
32 2021-06-25 muscle spasms, tingling, numbness 4 days after receiving the vaccine, I had severe fatigue, hear palpitations, tingling and numbness i... Read more
4 days after receiving the vaccine, I had severe fatigue, hear palpitations, tingling and numbness in my hands and face, anxiety and muscle spasm. I went to the ER and was hospitalized for 24 hours. At the hospital I received multiple tests but it was not discovered was caused my symptoms. Later my Primary Care provider diagnosed me with a B12 deficiency based on the same test results, and treatment with cobalamin injections has been very effective.
32 2021-06-26 cold sweat, feeling cold 4:10 PM: patient reported feeling "cold". Patient was clammy and upper extremities were cool to touc... Read more
4:10 PM: patient reported feeling "cold". Patient was clammy and upper extremities were cool to touch. Denies lightheaded, dizzy, nausea, other symptoms at this time. Brought back into exam room. Vital signs: BP 106/62, Pulse 62 bpm, Temp 97.1 F, O2 98%. 4:13 PM patient states that he is beginning to feel lightheaded. Lay patient flat on the exam table and propped up lower extremities. Pt lay for about 10 minutes and felt like sitting up, states he is having some improvement in symptoms. Gave him some water to drink and informed him to lay back for a bit longer so we can monitor him and not to get up too quickly because symptoms can return. After resting a bit longer, repeat vital signs at 4:30 PM: BP 120/78, Pulse 74, O2 99%, Temp 97.3 F. Pt reports full recovery from symptoms at 4:30 PM. Leaves the clinic without any distress, steady gait, and improved symptoms amd vital signs. Informed pt will report this and gave him instructions on what to do during next vaccination to prevent this from happening again. Pt verbalizes understanding. Go to ER if any symptoms return or if in any distress.
32 2021-06-27 weakness Persistent headache (started a few hours after receiving vaccine and has been present off/on through... Read more
Persistent headache (started a few hours after receiving vaccine and has been present off/on throughout the week) Fever (started morning after receiving vaccine, peaked at 103 degrees F, lasted 2 days) Fatigue (started morning after receiving vaccine, sleeping 14-16 hours a day with minimal energy during waking hours)
32 2021-06-28 cold sweat After 10 minutes, clammy hands which lasted for 10-15 minutes. After 4-5 hours, sore arm on injecti... Read more
After 10 minutes, clammy hands which lasted for 10-15 minutes. After 4-5 hours, sore arm on injection site. Soreness persisted and relieved for 3 days. After 5 days, louder than previously experience in right ear along with pressure inside of right ear. Persisted for a few hours, hard to sleep. Then relieved. After 5 days, scratchy throat, even swallowing caused gag reflex. Persisted for a few hours, hard to sleep. Then relieved. After 6 days, right arm lymph node swollen to a little over a half centimeter. Saw doctor and got blood test for white blood cell count. Has not relieved yet. Please contact me at a later date to understand how long it lasted.
32 2021-06-30 burning sensation, weakness weak; could not lift my arm up; blacked out and fell to the floor/ Unconscious; lost hearing; starte... Read more
weak; could not lift my arm up; blacked out and fell to the floor/ Unconscious; lost hearing; started to lose balance and couldn't stand and couldn't walk; started to lose balance and couldn't stand and couldn't walk; started to lose balance and couldn't stand and couldn't walk; very, very pale; zapped of energy; drenched in sweat; neck was burning, like it was on fire; complete loss of body function; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in left arm on 16Jun2021 12:15 (at the age of 32-year-old), as single dose for COVID-19 immunisation in pharmacy. The patient had no medical history present and no family medical history relevant to AE. The patient had no other products taken. The patient did not receive any other vaccines within four weeks prior to the vaccination. After received the first dose around 16:30 on 16Jun2021, the patient waited there 15 minutes after and was fine. Four hours later, the patient blacked out and fell to the floor. The patient stated he was unconscious for 30 seconds and then snapped back to life, drenched in sweat, started to lose balance, couldn't stand, and couldn't walk. The patient stated he did not have a phobia of getting a needle or anything like that. The patient stated he was not doing anything but eating dinner when it happened. For a minute or two while all this was happening, he states he lost his hearing. Then the patient was able to walk about 25 feet and tried to lean against the wall and then fell to the floor. Patient stated his buddy was there and tried to wake him up. The patient was still thinking in his mind but he didn't know where he was. He had complete loss of body function for about 20 minutes. The patient stated he was then able to lay down, drenched from sweat from head to toe, the cold air outside seemed to help, He stated his neck was burning, like it was on fire. The patient said that everything came out of left field. He seemed fine from 00:15 until 16:30 (on 16Jun2021). He felt zapped from energy, so he went to sleep from 16:45 until 23:00, which he seemed to help. The patient stated he has had nothing like that today, he was just weak and could not lift his arm. His face did get very, very pale when these events happened. He stated everything happened yesterday between 16:15 to16:45. The patient states for 20 minutes he had to lay down and get fresh air and during that time there was a moment he couldn't hear, he thought he had lost his hearing. Patient stated it was very scary and he considers himself a healthy male and tried to do all the right things. He states he did not have a fear of getting the vaccine, then everything hit him really hard. The patient underwent lab tests and procedures which included blood test: excellent. Outcome of the all events was resolved on 16Jun2021while outcome of the event zapped of energy was resolving and weak and could not lift my arm up was unknown.
32 2021-07-01 weakness motion sickness; Chills; Slight fever; Tiredness; Weakness; Flu like symptoms; This is a spontaneous... Read more
motion sickness; Chills; Slight fever; Tiredness; Weakness; Flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6206) via an unspecified route of administration in the left arm as a single dose on 13Mar2021 at 11:00 (at the age of 32-year-old) for COVID-19 immunisation. The medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6198), via an unspecified route of administration in the left arm on 20Feb2021 at 11:00, 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 been tested for COVID-19. Laboratory test included nasal swab on early March (for work) and the result was not provided. On 13Mar2021, the patient experienced mild flu like symptoms. On 15Mar2021, the patient experienced chills, slight fever, tiredness and weakness. On 15Mar2021 at 09:45, he had motion sickness while driving to a worksite (highway driving). 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 the reported events flu like symptoms, chills, slight fever, tiredness, weakness and motion sickness were recovered on an unknown date in Mar2021. No follow-up attempts possible. No further information expected.
32 2021-07-01 bell's palsy Bell's Palsy
32 2021-07-01 muscle spasms Bad headache; Bad muscle pain; Cramps; Fatigue; Low grade fever (~102 max); Diarrhoea; Feeling dehyd... Read more
Bad headache; Bad muscle pain; Cramps; Fatigue; Low grade fever (~102 max); Diarrhoea; Feeling dehydrated; sensitive skin; This is a spontaneous report received from a contactable consumer. A 32-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 9:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and ADHD (attention deficit hyperactivity disorder). The patient was allergic to penicillin. Concomitant medications included amfetamine aspartate, amphetamine aspartate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and salbutamol (ALBUTEROL) for unknown indications. The patient did not receive any vaccination 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 18Mar2021, the patient experienced headache, myalgia, muscle spasm, fatigue, low grade fever (102 maximum) (unspecified unit), diarrhea, dehydration and sensitive skin. No treatment was received for the 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 headache, myalgia, muscle spasm, fatigue, low grade fever, diarrhea, dehydration and sensitive skin was recovered with sequelae. No follow-up attempts are needed. No further information is expected.
32 2021-07-02 seizure New onset seizure. Total of 4; This is a spontaneous report from a contactable consumer (patient). ... Read more
New onset seizure. Total of 4; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 02Apr2021 07:00, at the age of 32-years-old, (Lot Number: ER8737) as DOSE 1, SINGLE; and via an unspecified route of administration, administered in right arm on 23Apr2021 07:00 (Lot Number: EW0171) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included seizure on 01Apr2021 05:00AM. The patient's 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. On unspecified date on Apr2021, after receiving the vaccine, patient had new onset seizure, total of 4. The event required ER visit, and the patient was hospitalized for 2 days due to this. Post vaccination, the patient been tested for COVID-19, tested with nasal swab with negative result on 24Apr2021. The outcome of the event was recovering. Information on Lot/Batch number was available. Additional information has been requested.
32 2021-07-05 cold sweat, feeling hot, tremor Patient was complaining of dizziness/shakiness 15 minutes after vaccine was administered. He was pro... Read more
Patient was complaining of dizziness/shakiness 15 minutes after vaccine was administered. He was provided with water, orange juice and granola bars, positioned with his feet up. He was no better after 1.5 hours and 911 was called at that time. EMTs evaluated the patient - he felt dizzy, shaky, pale, hot and clammy. Seated BP was measured at 144/98, standing up at 152/99. He was transported to hospital and admitted for observation. He was provided with food and fluids and experienced an adrenaline rush. Had ECG (normal?) and tachycardia. He was given an anti-anxiety medication and reassurance by medical staff. Discharged at around 9pm on 7/5/21. On checking up with patient 10am on 7/6/21 - he stated the expected muscle aches but otherwise feeling fine.
32 2021-07-13 coordination abnormal, weakness, tingling, numbness - Recieved first dose March 29th - Hands and Feet were Tingly/Numb April 2 - Saw Acute Care April 7,... Read more
- Recieved first dose March 29th - Hands and Feet were Tingly/Numb April 2 - Saw Acute Care April 7, Sent to ER and admitted to Hospital - Hospital for 6 days and recived IVIG - Recieved second IVIG Treatment Middle of April - Completely unable to walk or sit up unassisted for roughly 2 weeks. - Still have issues with numbness, weakness, coordination, vision and energy.
32 2021-07-13 discomfort Constant, roaring, and very loud tinnitus-mostly in right ear, but definitely in both ears Headaches... Read more
Constant, roaring, and very loud tinnitus-mostly in right ear, but definitely in both ears Headaches and facial pressure on right side, same side as loudest tinnitus Sparks of quickly arriving and quickly leaving severe chest pain slightly left of center
32 2021-07-17 migraine This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient re... Read more
This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male 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 22Mar2021 at 10:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history of patient included obesity (33.5 BMI with 21% body fat) and allergy to sulfonamide. The patient was allergic to morphine and ondansetron. Concomitant medications included multivitamin supplement (NATUREMADE) received within 2 weeks of vaccination. 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 01Mar2021 at 11:45 (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 has not been tested for COVID-19. On 22Mar2021, at 11:15, the patient experienced light-sensitivity migraine, bone and joint pain, altered temperature from (95.9 to 97.1) average temperature was 98.2, reduced mobility, and physical exhaustion. 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 the events. The clinical outcome of the events light-sensitivity migraine, bone and joint pain, altered temperature, reduced mobility, and physical exhaustion were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
32 2021-07-17 pain in extremity second dose: arm pain; second dose: headache; They both received an email that the vaccine was inval... Read more
second dose: arm pain; second dose: headache; They both received an email that the vaccine was invalid due to freezer storage beyond recommended date; They both received an email that the vaccine was invalid due to freezer storage beyond recommended date; This is a spontaneous report form a contactable consumer. This 36-year-old female consumer reported for a 32-year-old male patient (reporter's boyfriend) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EW0186, expiration date: 31Aug2021) via an unspecified route of administration, administered in left arm on 07Jun2021 at 14:58 as single dose for COVID-19 immunization. Patient's medical history (including any illness at time of vaccination) was none. There was no family medical history relevant to AE but cancer runs in his family but there has not been any scares or anything with him. The patient had no prior vaccinations (within 4 weeks). There were no AE following prior vaccinations. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EW0167, expiration date: 31Aug2021) via an unspecified route of administration, administered in left arm (upper) on 16May2021 at as dose 1, single for COVID-19 immunization and experienced headache and pain the arm. It was reported that patient received an email that the vaccine was invalid due to freezer storage beyond recommended date and administered on 07Jun2021 at 14:58. The email indicated that the facility had reached out to the center and it was recommended that they take a third dose. The reporter stated that her boyfriend had taken the first and second dose at the same exact date and time. The reporter stated that, when the patient had the second dose, the patient had pain in the arm and a little headache. The patient not visited to emergency room and physician office. No treatment medications were received for the adverse events. The outcome of the events was unknown. Follow up information has been requested.; Sender's Comments: Linked Report(s) : 2021814858 same reporter, dose, drug and event, different patient.
32 2021-07-17 pain in extremity first dose: pain in the arm; first dose: headache; This is a spontaneous report from a contactable c... Read more
first dose: pain in the arm; first dose: headache; This is a spontaneous report from a contactable consumer or other non hcp. A 32-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 16May2021 (Batch/Lot Number: EW0167; Expiration Date: 31Aug2021) as DOSE 1, SINGLE for COVID-19 immunization. Medical history was reported none. The patient's concomitant medications were not reported. The patient experienced first dose: pain in the arm on 16May2021, first dose: headache on 16May2021The outcome of the events was unknown.
32 2021-07-18 numbness, tremor, tingling After 2 hours or so of taking the first dose of the Pfizer vaccine, I started feeling numbness and t... Read more
After 2 hours or so of taking the first dose of the Pfizer vaccine, I started feeling numbness and tingling all over the body specially in the hands and face. After 3 days it got worse and my hands started shaking a bit but could barely feel if I was holding something or not. Swallowing was painful and walking felt strange. Went to the er and the doctor told me it was inflammation and recommended to still take the second dose. After a week it got better. But when I took the second dose the effects came back again. Not as strong as when they started but it?s been more than a month since the second dose and I still have the symptoms.
32 2021-07-26 cold sweat The recipient was vaccinated at 1:09pm on 07/22/2021 with Pfizer vaccine ( first dose). While waiti... Read more
The recipient was vaccinated at 1:09pm on 07/22/2021 with Pfizer vaccine ( first dose). While waiting in the observation patient walked to the window and said he felt dizzy. As the nurse walked about 3 feet to attempt to escort him to sit back down he fell to his back hitting his head. He was clamy, cool , sweating but alert to person, place and situation.
32 2021-07-27 pain in extremity Soreness in body; Congestion in nose; Congestion in throat; Nausea; Itching in random spots on body;... Read more
Soreness in body; Congestion in nose; Congestion in throat; Nausea; Itching in random spots on body; Headache; just overall felt terrible.; Soreness in neck area; Soreness in injection arm; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 10:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included Localized epidermolyisis bullosa simplex from an unspecified date. Concomitant medications included terbinafine (LAMISIL), ascorbic acid; biotin; calcium pantothenate; cyanocobalamin; ergocalciferol; iron; nicotinamide; pyridoxine hydrochloride; retinol; riboflavin; thiamine hydrochloride; tocopheryl acetate (CENTRUM) all from an unknown date for an unspecified indication. 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 the patient experienced soreness in injection arm, side and neck area. On 02Apr2021 the patient experienced a headache and nausea and just overall felt terrible. Over the next few days, soreness in body, congestion in nose and throat, and itching in random spots on body. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of neck pain, general body pain, nose congestion, throat constriction, nausea, painful arm, itching, headache, feeling miserable was resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.
33 2021-01-03 pain in extremity Low degree fever (99.8 F) in the night of 01/02 until the afternoon of 01/03. Sore left arm and feel... Read more
Low degree fever (99.8 F) in the night of 01/02 until the afternoon of 01/03. Sore left arm and feeling unwell throughout the day.
33 2021-01-04 weakness, muscle spasms Weakness, dizziness, lightheaded, cramps, chest pain, shortness of breath, headache.
33 2021-01-05 weakness Within 1 hour, increasing dizziness and vertigo like symptoms, loss of appetite, followed by fatigue... Read more
Within 1 hour, increasing dizziness and vertigo like symptoms, loss of appetite, followed by fatigue weakness and febrile episodes by 10pm that evening. These persisted until 0300AM on the 19th.
33 2021-01-06 pain in extremity Arthralgia, UrticariaPruritus, NauseaVomiting, stomach cramps Narrative: 12/29 approximately 15 min ... Read more
Arthralgia, UrticariaPruritus, NauseaVomiting, stomach cramps Narrative: 12/29 approximately 15 min after vaccination, employee reports onset of "foggy brain", stomach cramps, and widespread itching. He was transferred to the ED. Evaluation revealed no rash and the physical exam was normal. He was treated with 50 mg of benadryl PO and observed in the ED for about 90 minutes and discharged back to work. He was given a prescription for hydroxyzine 25 mg po q 6 hours x 5 days. On 12/30 - he reports his arm is sore and he still feels itchy. Now he has some nausea and his joints hurt. He plans to stay home from work to rest today. He had to leave work early yesterday (works night shift). 12/31 - reports he feels better but still has a headache and feels achy. He hasn't taken the hydroxyzine because his itching is not as intense. 1/4 employee reports his symptoms have improved and has mild achiness, fatigue, and itching which he describes as 1-2 on a scale of 1-10.
33 2021-01-06 tingling I sat in a chair after I received the vaccine. After 10 minutes I stood up and my legs were tingling... Read more
I sat in a chair after I received the vaccine. After 10 minutes I stood up and my legs were tingling and felt heavy. I was slightly lightheaded too. I sat back down for a few more minutes and then I went back to work. The the tingling stopped but my legs felt heavy for 3 days. I am feeling normal now. I am aware of orthostatic hypotension and the possibility of it being from sitting in the chair and pinching nerves. I just wanted to report this in case it is a problem.
33 2021-01-07 weakness Onset lethargy feeling ?down? and drained of energy and ?foggy?
33 2021-01-07 pain in extremity, numbness, tremor, weakness Pfizer-BioNTech COVID-19 Vaccine EUA. After 10 minutes I started hyperventilating, difficulty breath... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. After 10 minutes I started hyperventilating, difficulty breathing, difficulty swallowing, Left arm numbness, lightheaded, and elevated heart rate. After 1 hr symptoms subsided as I was looked after by 3 nurses. Then last night I woke up at 3 am with body aches, chills, difficulty breathing, lightheaded, tremors, sore arm, elevated heart rate, and swollen injection site. By 6:30 I was sitting up but still too weak to stand. By 9 am I am still lightheaded, sore arm, body aches, and fatigue.
33 2021-01-10 pain in extremity Normal, arm soreness in the beginning. This morning. Skin on hands starting to peel. Has not been in... Read more
Normal, arm soreness in the beginning. This morning. Skin on hands starting to peel. Has not been in the sun. No behavioral changes for the patient.
33 2021-01-10 tingling, pain in extremity Headache started within 30 minutes of vaccine and Lasted 36 hours. Moderate arm pain for at least 4... Read more
Headache started within 30 minutes of vaccine and Lasted 36 hours. Moderate arm pain for at least 48 hours. One episode of chills and sweats first night. One episode each of Paresthesias in left upper and left lower extremity first night.
33 2021-01-11 feeling hot body sweats; bad headaches; Runny nose; his body was warm and the cheeks were warm.; This is a spont... Read more
body sweats; bad headaches; Runny nose; his body was warm and the cheeks were warm.; This is a spontaneous report from a contactable consumer (patient self). A 33-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at 11:20 at single dose on right arm for COVID-19 immunisation. Medical history included kidney disorder. He was not allergic to peanuts. He did catch COVID and had a positive test back in Apr2020. He had not taken any antibody test. He had no issues with vaccines in the past. Concomitant medications included levothyroxine sodium (SYNTHROID), hydrochlorothiazide for kidney, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) (he didnt take this he need a refill). The patient developed bad headaches and body sweats on 07Jan2021. The patient reported he had side effects after getting his first covid vaccine. He got the shot on 06Jan2021 and over night developed a bad headache, body sweats, and had to call out of work today. He stated that he was laying in bed after a hot shower. He received his 1st dose on 06Jan2021 at 11:20 in the morning. He had No symptoms the of receiving the vaccine. Now because he is a Volunteer Fire Fighter, he woke up at 2-3 AM today this morning (07Jan2021) and that's when the headache started, it was gradually increasing. He took a hot shower and that made it better behind the neck but now its worse. His body sweats when he was sleeping this morning, his body was warm and the cheeks were warm. He also added that he had a runny nose that started the same time as the headache. The body sweats were on and off, its like his body was trying to fight it. Outcome of event headaches, body sweats and runny nose was not recovered, outcome of other events was unknown. Information about Lot/Batch number has been requested.
33 2021-01-11 tingling Tingling in hands and feet which started about 1.5 hour after I took the vaccine
33 2021-01-13 hot flush Patient reports lightheadedness, fatigue, chills, hot flashes, sore throat, loss of appetite, light ... Read more
Patient reports lightheadedness, fatigue, chills, hot flashes, sore throat, loss of appetite, light cough and nausea when consuming food or water
33 2021-01-13 hypersensitivity of all senses Fever, Chills, body aches & skin sensitivity starting 22 hours post second dose of Pfizer's Covid-19... Read more
Fever, Chills, body aches & skin sensitivity starting 22 hours post second dose of Pfizer's Covid-19 vaccine. Symptoms resolved in 5 hours with continued use of Tylenol. Sore arm persists 3 days later.
33 2021-01-13 pain in extremity, feeling cold, hot flush Left arm pain that began around 5pm. Chills and headache started around 7pm. Low grade fever, hot fl... Read more
Left arm pain that began around 5pm. Chills and headache started around 7pm. Low grade fever, hot flashes and cold chills persistent all night.
33 2021-01-14 feeling hot, weakness Vaccine at 8:30am in the morning. Around 4 pm started feel warm, weakness. Took Tylenol 1000 mg. ... Read more
Vaccine at 8:30am in the morning. Around 4 pm started feel warm, weakness. Took Tylenol 1000 mg. Helped a little bit. Today still having bodyache and chills.
33 2021-01-14 pain in extremity Woke up with low grade fever 99.9. Felt low back pain, chills, arm pain, and fatigue. Took Tylenol 1... Read more
Woke up with low grade fever 99.9. Felt low back pain, chills, arm pain, and fatigue. Took Tylenol 1000 mg and Naproxen 440mg. Symptoms decreased around 5pm and fever subsided around 9pm.
33 2021-01-16 muscle spasms Severe Right sided chest pain, right sided muscle spasms and difficulty breathing two weeks after va... Read more
Severe Right sided chest pain, right sided muscle spasms and difficulty breathing two weeks after vaccine was administered Diagnosis of bilateral pulmonary embolism was made on presentation to ER. No personal or family history of clots in arteries or deep veins or any risk factors in patient. Received heparin drip, pain medications, muscle relaxants inpatient. Pain progressively improved over days. Was discharged after 6 days on admission. Was discharged on oral anticoagulant (Rivaroxaban aka xarelto)
33 2021-01-19 cold sweat, pain in extremity I had the same symptoms on the dose two, as I did in dose 1, same timeline. My arm got heavier and h... Read more
I had the same symptoms on the dose two, as I did in dose 1, same timeline. My arm got heavier and hurt quite a bit. I was feeling feverish by the end of the day, a slight head ache, clammy, mental fog, exhausted. The following day I had waves of nausea, and each of the previously reported symptoms were stronger. The headache grew stronger and I was relatively useless, feeling very ill. By the next day the 16th most of the symptoms had cleared up. I had a slight headache and felt a bit tired, but much better. By the 18th, I was back to normal with the only symptom being a sore arm.
33 2021-01-20 hot flush, tremor Chills, shaking, hot flashes, headache body aches for 24 hours
33 2021-01-20 hot flush Hives sporadically throughout body, headache, hot flashes
33 2021-01-20 numbness Patient tongue went numb approximately 15 to 20 minutes after the shot, cheeks went slightly numb ab... Read more
Patient tongue went numb approximately 15 to 20 minutes after the shot, cheeks went slightly numb about an hour after shot. All symptoms resolved within 1.5 hours. Patient described as feeling like 2hrs post-novocaine shot at the dentist.
33 2021-01-21 night sweats Got the second dose of the COVID 19 vaccine. The next morning felt mild to moderate symptoms. Later ... Read more
Got the second dose of the COVID 19 vaccine. The next morning felt mild to moderate symptoms. Later in the day had more intense symptoms including headache, myalgia, and fatigue (needed to lie down). Continued throughout the evening with night sweats. Woke up Sunday morning feeling significantly better but with persistent mild symptoms.
33 2021-01-21 pain in extremity enlarged lump under left arm after receiving COVID 19 vaccine # 2 on 1/19/2021 to left deltoid. Got ... Read more
enlarged lump under left arm after receiving COVID 19 vaccine # 2 on 1/19/2021 to left deltoid. Got initial does to the left deltoid and tolerated it well. Mild arm soreness. The day he received his 2nd dose he again had arm soreness. On 1/21 he noticed a firm tender lump under the left arm. He denies any fever/chills, redness or swelling to the area. No hx of vaccine reactions in the past
33 2021-01-22 tingling While driving home in traffic from getting the vaccine, I felt a tingling over my whole body and the... Read more
While driving home in traffic from getting the vaccine, I felt a tingling over my whole body and then everything started to spin (vertigo). This lasted for about 10 seconds of severe vertigo and then stopped. I thought that was weird and kept driving (was in stop and go traffic) then about 1 minute later it started again and thankfully I was stopped at the time in traffic. I leaned my seat back slightly and called my wife to tell her where I am. I couldn't pull over because there was a cement barrier on one side and 4 lanes of traffic on the other. I kept on the phone with her for the remained of my drive and it occurred one more time when I was driving home. Once home, a couple more times I felt it coming on but it didn't ever happen again. I took my blood pressure and it was normal, boarderline high when I got home (140/84). The next morning I had a fever and severe muscle aches and body aches which lasted most of the day and then today I've felt totally fine (today being 1/23).
33 2021-01-24 night sweats Vaccine received 12/19, began to feel ill later that evening. Nightsweats and emesis. With confusi... Read more
Vaccine received 12/19, began to feel ill later that evening. Nightsweats and emesis. With confusions and hallucinations. Admitted to the hospital 12/21-12/27/20 for encephalitis.
33 2021-01-25 tingling flu-like sxs. joint and muscular pain. abdominal cramping. pins and needles/hypersensitive skin. hea... Read more
flu-like sxs. joint and muscular pain. abdominal cramping. pins and needles/hypersensitive skin. headache. fever. unable to sleep. sxs had rapid onset appx 12 hrs after dose administration, have continued for 12 hrs to current time.
33 2021-01-27 hypersensitivity of all senses mild dyspepsia; loose stools; Moderate deltoid soreness at injection site; chills; myalgias; hyperal... Read more
mild dyspepsia; loose stools; Moderate deltoid soreness at injection site; chills; myalgias; hyperalgesia; headache; fatigue; grogginess; This is a spontaneous report from a contactable physician reported for himself. A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 07Jan2021 08:45 at single dose in left arm for covid-19 immunization. The patient medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included triamcinolone 1% cream and diphenhydramine 2% cream. The 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, lot number EJ1685), via an unspecified route of administration on 17Dec2020 05:00 PM at single dose in left arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. On 07Jan2021 12:00, the patient experienced moderate deltoid soreness at injection site within 2-3 hours; chills, myalgias, hyperalgesia, headache, fatigue, grogginess from 12-36 hours post injection (on 07Jan2021); mild dyspepsia and loose stools 24-36 hours post-injection (on 08Jan2021). The patient did not received treatment for the events. The outcome of the events was recovered in Jan2021.
33 2021-01-27 migraine Migraine for 10 days. Never had a migraine before.
33 2021-01-27 tremor, feeling of body temperature change About an hour after I received my second shot I felt extremely hot and my knees and elbows started t... Read more
About an hour after I received my second shot I felt extremely hot and my knees and elbows started to hurt. I felt so hot that I walked outside to my car (about .3 miles away) in freezing cold temperatures with no jacket and didn't feel the cold at all. I developed a brain fog shortly thereafter and made several mistakes while performing my job throughout the day. My supervisor provided me with extra strength tylenol and within an hour or so the joint pains subsided. By 7 PM that night I had very bad chills and was shaking under a blanket on my couch. My temperature got up to 99.8 which is pretty high for me. I went back and forth between feeling like I was freezing cold and on fire. I got very little sleep that night and had disturbing dreams. The following morning all my joints hurt and I felt extreme exhaustion. I laid on my couch all day the day after receiving the shot and felt exhausted and and had no appetite. From 6 PM the day of the shot to 9 PM the following day I ate NOTHING and had no desire to eat. As I'm typing this 60 hours after receiving the second shot the joint pain is gone, the exhaustion is gone and my appetite is back to normal. There's a lingering pain at the injection site but otherwise I feel like I did prior to receiving the second shot.
33 2021-01-28 night sweats 12/30 vaccine 1/1 about 12 started to feel fever, HA, fatigue, chills, body aches, night sweats. 10... Read more
12/30 vaccine 1/1 about 12 started to feel fever, HA, fatigue, chills, body aches, night sweats. 101 at highest point for temp. Took Ibuprofren. Doraflu from urgent care.
33 2021-02-02 flushing After vaccination, patient felt light headed and sought us out. Patient had not eaten since breakfa... Read more
After vaccination, patient felt light headed and sought us out. Patient had not eaten since breakfast, and then had a protein shake. He did have some water/fluids prior to arrival. Patient was flushed, dizzy, lightheaded, and tachycardic. Patient placed in recumbent position and Given water/juice Initial vitals- 145/85 pulse 115 O2 98% sats Patient felt much improved with fluids and a snack. Discharge Vitals- 135/85 Pulse 90; did not recheck O2 sat Patient discharged in stable condition.
33 2021-02-04 numbness Sporadic facial and arm numbness on vaccine side (left). Numbness locations in arm localized around ... Read more
Sporadic facial and arm numbness on vaccine side (left). Numbness locations in arm localized around shoulder, hand, and fingers. Noticeable Numbness in face localized to lower front jaw, top of left ear, and above left eye (around eyebrow)
33 2021-02-04 migraine, hot flush Fatique, fever and chills, 100 degree temp, physically felt bad but mentally felt well, malaise. 12-... Read more
Fatique, fever and chills, 100 degree temp, physically felt bad but mentally felt well, malaise. 12-36 hours post injection. Treatment was hydration and bed rest. Migraine (7 on 0 to 10 scale), dry cough, transient hot flashes. 36 to 60 hours post injection. Treatment included Tylenol otc, aspirin otc, flonase otc, caffeinated drinks, bed rest. Tinnitus, 60 hours and continuing post injection
33 2021-02-05 tremor I woke up in the middle of the night with sever chills. My body was shaking uncontrollably. I took a... Read more
I woke up in the middle of the night with sever chills. My body was shaking uncontrollably. I took an ibuprofen and then took a 40 minute hot shower. My chest felt tight and I couldn?t catch my breath, so I called 911 for extra precaution. My vitals were good so I was advised to take ibuprofen and stay hydrated. This chills, achy body, headache lasted the whole day. Chills, headache, body aches. It wasn?t until about 48 hours after the shot that I began to feel better.
33 2021-02-06 involuntary muscle movements, grand mal seizure, feeling cold 10 hours after receiving injection, spontaneously began feeling cold, shivering to rigors, rapid hea... Read more
10 hours after receiving injection, spontaneously began feeling cold, shivering to rigors, rapid heart rate increased respiratory rate, lips and nail bed dusky, T37C. Took to ER, Temp 101 F and experienced a grandmal seizure, lasting approximately 1 minute of vigrous movement. froathing and flaying . Temp up to 103F. tachycardia and SOB, PO2 in 90's blood pressure low 78/45 88/50 after 3 liters of fluid up to 100/50. Chest Xray, EKG, multiple labs blood and one urine text.
33 2021-02-08 weakness 12/22/2020 vaccination 1/2/2021 I woke up and felt exhausted, groggy. 1/3-1/4 still felt exhausted.... Read more
12/22/2020 vaccination 1/2/2021 I woke up and felt exhausted, groggy. 1/3-1/4 still felt exhausted. 1/6 this is abnormal. I went to work and felt 'weak'. Effort to do normal activities at work. transported to ER. Prescribed zofran. symptoms subsided by sat. I started to feel better and maneuver better.
33 2021-02-09 seizure Patient received vaccine in AM, had seizure in PM at work with typical post-ictal picture. Has epil... Read more
Patient received vaccine in AM, had seizure in PM at work with typical post-ictal picture. Has epilepsy but no seizure since 2014. Also has history EtOH misuse but history not consistent with withdrawal. Patient had some waxing and waning altered mental status, worsening slowly over next 2-3 days. Presented to ER with AMS. Initially thought to be EtOH withdrawal, but due to atypical clinical appearance, LP performed and HSV encephalopathy diagnosed.
33 2021-02-10 pain in extremity, cold sweat Arm soreness; cold sweats; This is a spontaneous report from a contactable consumer. A 33-year-old... Read more
Arm soreness; cold sweats; This is a spontaneous report from a contactable consumer. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231) on 21Jan2021 at 12:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 21Jan2021 at 16:00 the patient experienced Arm soreness and cold sweat. Treatment for the events were not administered. On an unspecified date the patient recovered from the events.
33 2021-02-11 burning sensation, tremor, tingling I noticed a headache in the very top of my head within an hour of getting the vaccine. I thought it ... Read more
I noticed a headache in the very top of my head within an hour of getting the vaccine. I thought it was normal because everyone I know said they got a headache from it. Over the next few hours, the pain moved down the back of my neck and became a burning sensation at the bottom of my skull. The pain was not excruciating but was constant. I thought it would eventually go away. I'm a pilot and fly for a living. Two days after receiving the vaccine I flew my plane and immediately noticed something was wrong with me. I was having a very hard time focusing. Approximately 2 hours into my flying I felt sudden and extreme pressure in my head and nearly blacked out. I immediately landed and stopped flying. Two days later I tried flying again and the exact same thing happened again after 20 minutes. The burning in my neck intensified and was now accompanied by dizziness, nausea, disorientation, confusion, uncontrollable shaking, and tinkling in my toes and fingers. I immediately went to my hometown doctor and he diagnosed me with vertigo. He prescribed me meclizine on Friday 02/05/2021. I took the medicine as prescribed all weekend with no relief. Monday 02/08/2021 I made an appointment for that Wednesday at the Institute. During Wednesday 02/10/2021-02/11/2021 I had roughly 10-15 test performed on me including balance, eye and hearing test, CT scan, MRI, and measured my spinal fluid pressure. The physician determined on 02/11/2021 that I had an allergic reaction to the Pfizer COVID vaccine the severely increased the pressure in my spinal cord and brain stem. That pressure causes my vision problems and ultimately ruptured my left inner ear breaking off several crystals in the process. I cannot fly with this condition. I'm currently taking Diamox to reduce the pressure in my spinal cord and brain stem.
33 2021-02-13 weakness On 26DEC ( 5 days after first injection), he started experiencing pain and weakness in the Right de... Read more
On 26DEC ( 5 days after first injection), he started experiencing pain and weakness in the Right deltoid radiating down to the fingertips . Within a week, started feeling similar symptoms in Left extremity. No shoulder/neck pain. Pain starts at the deltoid at the injection site and has caused stiffness, pain, and tightness of the upper extremities alone. Decreased grip b/l. Symptoms have persisted since ( almost a month now) but did seem to resolve while on prednisone, but returned after cessation. No respiratory issues, chest pain, paresthesias, or lower extremity symptoms.
33 2021-02-14 seizure spiked a fever of 101.3; spiked a fever of 101.3 which cause a 20 minute seizure; spiked a fever of ... Read more
spiked a fever of 101.3; spiked a fever of 101.3 which cause a 20 minute seizure; spiked a fever of 101.3 which cause a 20 minute seizure; headache; This is a spontaneous report from a contactable consumer reported for himself. A 33-years-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at right arm on 25Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included seizure disorder and other neurological issues, allergy to latex. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), omeprazole, lacosamide (VIMPAT), lamotrigine (LAMOTRIGINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included 1st dose of BNT162B2 (lot number: EK9231) on 04Jan2021 12:00 PM at left arm for COVID-19 immunization when he was 32-years-old. The patient had a headache throughout the following day and evening on 26Jan2021. On 27Jan2021 spiked a fever of 101.3 which cause a 20 minute seizure. He was hospitalized for 2 days. Events resulted in emergency room/department or urgent care, hospitalization. Treatment was received for the adverse event in hospital. The events outcome was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The report was reported as serious with seriousness criteria-caused hospitalization.
33 2021-02-15 tingling Patient had a tingly face and lips 10 minutes after dose, same as last time. Last time resolved aft... Read more
Patient had a tingly face and lips 10 minutes after dose, same as last time. Last time resolved after 45 mins and a workout. Feels same, refused ambulance evaluations.
33 2021-02-16 muscle spasms Aches, headache, fatigue, vomitting. Started roughly 24 hours after shot. Had muscle spasms and sev... Read more
Aches, headache, fatigue, vomitting. Started roughly 24 hours after shot. Had muscle spasms and severe vomitting.
33 2021-02-18 involuntary muscle movements RESPIRATORY DIFFICULTY TIGHT CHEST SOB DIZZINESS LOW MOTION COORDINATION INVOLUNTARY MOVEMENTS
33 2021-02-19 pain in extremity Fatigue, Chills, headache, sore arm. The sore arm lasted a couple of days. The other symptoms went a... Read more
Fatigue, Chills, headache, sore arm. The sore arm lasted a couple of days. The other symptoms went away after 24h.
33 2021-02-19 tingling, numbness Fingers felt tingly and then hand felt numb. Started after shot. Seen by EMT, reported site looks ... Read more
Fingers felt tingly and then hand felt numb. Started after shot. Seen by EMT, reported site looks good. No difficulty breathing.
33 2021-02-20 tremor At 09pm experienced a severe fever. (the type i experienced with Sepsis) No other symptoms. It was... Read more
At 09pm experienced a severe fever. (the type i experienced with Sepsis) No other symptoms. It was a debilitating fever with chills and severe shaking. I took acetaminophen with some crackers and plenty of water at 10pm. Fever broke by 01am. I followed with a more water and ibuprofen and fell asleep around 02am. Following morning, I feel pretty good, slightly tired but other wise normal. I have had no gastrointestinal or noticeable issues before or following. The episode was near the point of going to ER. It was something utterly unexpected and I've never experienced a fever with no cause.
33 2021-02-21 burning sensation, tingling, tremor diagnosed with vertigo; Allergic reaction which elevated patient's spinal cord pressure and brain st... Read more
diagnosed with vertigo; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Very hard time focusing my eyes; Extreme burning and tingling sensation over his entire body; Extreme burning and tingling sensation over his entire body; extremely dizzy; confused; nauseous; uncontrollably shaking; Headache; This is a spontaneous report from a contactable consumer reporting for himself. A 33-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Feb2021 at 11:00 AM, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient had no known allergies and did not receive other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. On 01Feb2021 at 12:00 PM the patient developed a headache. Over the next few hours the headache moved to the back of his neck and base of his skull. On 03Feb2021 the patient experienced very hard time focusing his eyes and extreme burning and tingling sensation over his entire body, he was extremely dizzy, confused, nauseous and uncontrollably shaking. Patient went to his family doctor and was diagnosed with vertigo on 05Feb2021. Patient took meclizine with no relief. On 10Feb2021 the patient was visited by another doctor and went under two days of testing including acoustic stimulation tests, balance test, visual acuity tests, CT scan and MRI all with unknown result. The doctor said the vaccine shot caused an allergic reaction which elevated patient's spinal cord pressure and brain stem swelling. Therapeutic measures were taken as a result of spinal cord pressure and included treatment with Diamox. Outcome of the events was not resolved. The events were considered serious as life-threatening and as per disability. Patient was not tested positive for COVID-19 after vaccination. The information on the lot/batch number has been requested.
33 2021-02-24 muscle spasms, pain in extremity Starting Monday February 22 (six days after second dose), I experienced moderate muscle cramping and... Read more
Starting Monday February 22 (six days after second dose), I experienced moderate muscle cramping and soreness in the back of the neck, lower back, and buttocks/legs. I am also experiencing headache, dizziness, and diarrhea, all moderate. Symptoms are temporarily relieved by massage and stretching, but pain is still ongoing. This has persisted until today (Thursday, February 25).
33 2021-03-03 inability to speak, seizure lightheadedness after about 5 minutes followed by confusion and loss of consciousness. Brief seizure... Read more
lightheadedness after about 5 minutes followed by confusion and loss of consciousness. Brief seizure and short-term aphasia.
33 2021-03-05 face paralysis, numbness, bell's palsy Patient was vaccinated at the Community Center (not our clinic) and called us today with symptoms of... Read more
Patient was vaccinated at the Community Center (not our clinic) and called us today with symptoms of Bell's Palsy (left side of face feeling numb and visibly weak including left eyelid) that began on March 4th and slowly worsened. I prescribed prednisone 60mg daily x7 days, with plan to f/u with another phone visit this week.
33 2021-03-07 tingling Tingling in torso, arms and legs almost like pins and needles sensation; This is a spontaneous repor... Read more
Tingling in torso, arms and legs almost like pins and needles sensation; This is a spontaneous report from a contactable healthcare professional (patient). A 33-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN9581, expiry date not reported), via an unspecified route of administration at the left arm on 05Feb2021 10:15 at single dose for COVID-19 immunization. Medical history included hyperlipidaemia, COVID-19, and sulfa drugs. The patient was vaccinated at a hospital. Concomitant medications included atorvastatin (LIPITOR) and fish oil. Historical vaccine included first dose of bnt162b2 (lot number: EK9231, expiry date not reported) in the right arm on 15Jan2021 08:00 at single dose for COVID-19 immunization. The patient experienced tingling in torso, arms and legs almost like pins and needles sensation on 05Feb2021 16:00 with outcome of unknown. No therapeutic measurement was given as a result of the event.
33 2021-03-10 numbness, tingling Facial numbness on left side, lip numbness, facial tingling, dry mouth
33 2021-03-10 pain in extremity Pain in left upper arm developed the day after 2nd COVID vaccine on 1/22/21. Persistent upper left... Read more
Pain in left upper arm developed the day after 2nd COVID vaccine on 1/22/21. Persistent upper left arm pain, especially with internal rotation and abduction of shoulder. No redness, swelling, weakness, numbness or tingling.
33 2021-03-10 tingling I started having radicular tingling with neck flexion that ran down my left leg starting at the begi... Read more
I started having radicular tingling with neck flexion that ran down my left leg starting at the beginning of February. I noted it to a colleague and asked if anyone else who had received the vaccine at the same time as me had any similar effects. I was the only person noted. Slowly the tingling increased and began radiating the entire length of the left leg. It only last for a few seconds at the beginning of flexion then completely resolved. I did not think much of this at the time and figured that it would resolve. On February 27, I began having visual disturbances and symptoms similar to vertigo with a severe nystagmus with a gaze the the right. I attempted a round of azithromycin at this time thinking that there may be an ear infection and that was causing my visual/vertigo like symptoms. There was no improvement with this course of treatment and the visual issues were becoming more of a regular issue. It became hard for me to focus anytime that I would look to my right but was able to focus my eyes while looking forward and the the left. At this time, I opted to have a brain MRI done which was completed on Match 9th as well as having basic labs run. I ended up with an elevated white count on my labs with a left shift. My MRI was read the same day showing a demyelinating process. Multiple neurologist were consulted on this and they believe that my symptoms are not related to MS as the radiologist listed as his top three on his differential but rather what they called post-covid vaccine syndrome, similar to what they are seeing with patients who actually had COVID. I have no medical history, I am not taking any medications and had no symptoms prior to the vaccine. My symptoms were acutely brought on unlike MS and I do not have any of the four most common male characteristics of MS. I do not currently have any muscle weakness, I am not fatigued, it has not progressed to my upper extremities, it does not have a stalking glove approach but rather shoots down, I have no sexual dysfunction. I have been started on a high dose prednisone taper as recommended by the neurologist. My biggest concern is that when I looked for information as a medical provider, I was unable to find anything related to neurological issues and the vaccine. Once, I was placed in contact with multiple neurologist, I was told that they are seen quite a few neurological adverse events.
33 2021-03-10 seizure First time seizure, normal MRI and EEG on workup
33 2021-03-12 flushing, unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: Patient had short fainting spell post vaccination while seated, immunizer was a registered nurse who provided immediate care, checked blood pressure, 100/60 then 125/90 10 minutes later, patient was upright and responsive after being assisted. after observation period left on own ability with mother. left message with pcp office post event, spoke with patient following morning, no issues feeling fine.
33 2021-03-12 migraine Severe chest pain. Migraine headaches
33 2021-03-14 migraine Acute new onset of migraine or cluster headache on left side of temporal/eye area 3 days after first... Read more
Acute new onset of migraine or cluster headache on left side of temporal/eye area 3 days after first jab.
33 2021-03-14 muscle spasms Neck pain/cramps in neck/muscle spasm in neck
33 2021-03-15 cold sweat The first adverse effect started a couple minutes after the injection. I felt lightheaded and dizzy ... Read more
The first adverse effect started a couple minutes after the injection. I felt lightheaded and dizzy and then I broke out into a cold sweat followed by blurry vision. I felt as though I was going to pass out. These symptoms lasted for approximately 10-12 minutes after starting and then I started to feel better. I then experienced a headache in just above the base of my neck in the back of my head and that lasted for approximately 5 minutes.
33 2021-03-15 feeling hot, tingling Patient developed tingling in fingers, shortness of breath, pruritic rash to forehead and chest, bl... Read more
Patient developed tingling in fingers, shortness of breath, pruritic rash to forehead and chest, blanched with applied pressure, associated sweating, feeling hot and shaky within 20 minutes of vaccination.
33 2021-03-15 pain in extremity, numbness pt c/o of rt. hand pain after the vaccine, numbness of both hand. chest tightness after 10 mins of... Read more
pt c/o of rt. hand pain after the vaccine, numbness of both hand. chest tightness after 10 mins of vaccination. the symptoms were resolved and patient went home.
33 2021-03-15 tingling, numbness an hour after my injection I had tingling and numb sensation on my face. I checked in the mirror to ... Read more
an hour after my injection I had tingling and numb sensation on my face. I checked in the mirror to see if i was having a stroke but I was fine. I was still numb and tingly so I went to the ER (03/8/21) a few days later. its now been 2 weeks and I get the numbness and tingling off and on. Doctors say to just keep an eye on it and make sure I don't get any drooping. I can still feel myself touch my face but it still has a tingly numb sensation.
33 2021-03-19 night sweats Sunday, headache began to form. The, what appeared to be bite marks, found on right leg. Monday, day... Read more
Sunday, headache began to form. The, what appeared to be bite marks, found on right leg. Monday, day long headache. Tuesday, horrible headache, nausea, night sweats, chills. ER diagnosed it as reaction from spider bite. Wednesday, headaches, more bumps. Thursday, headaches, nausea. Friday, headaches, more bumps on right leg, itching on right leg, ringing in right ear. Contacted doctor on Friday with pictures, and he diagnosed it as shingles.
33 2021-03-21 feeling hot Patient complained of feeling hot and mild shortness of breath @14:03. Pulse ox 98% on RAD pulse 99-... Read more
Patient complained of feeling hot and mild shortness of breath @14:03. Pulse ox 98% on RAD pulse 99-102bpm. Lungs clear to auscultate, he said his breathing got better but started feeling dizzy & swelling. Sent to ER
33 2021-03-21 hot flush, tingling 33y/o male reports itching on the bottom of both feet at ~17min post-Pfizer vaccination into the lef... Read more
33y/o male reports itching on the bottom of both feet at ~17min post-Pfizer vaccination into the left arm on 3/17/21. He states that he has h/o allergic reactions that typically present this way. He reports pain at injection site that he rates as a 3/10. He has associated itching/tingling sensation that he rates as a 2/10. He also feels flushed/heat in his face. He denies throat discomfort/swelling, difficulty breathing, shortness of breath, chest pain, palpitations, blurry vision, dizziness, lip/tongue swelling, or nasal congestion. Patient reports resolved sensations at 35min post-injection. He reports h/o allergic reactions to river water, Chantix, Zyrtec and seasonal allergies. He states that he has never needed epinephrine and his past symptoms resolved without intervention and he was monitored. Physical Exam: BP; 155/110 Cardiac: regular heart rate and rhythm. Radial Pulse 2+ Lungs: Clear to auscultation bilaterally Skin: no rash, erythema, or injection site redness/swelling Plan: Patient reported symptoms resolved at 35min after injection and left clinic. He was advised to call 911 if he develops any allergic reactions or respiratory issues including hives, difficulty breathing, chest pain, or throat/lip/tongue swelling. He was also informed that his blood pressure was high and that he would need to follow up with his PCP. Patient reports that it typically rises when he speaks to providers.
33 2021-03-22 weakness, migraine Rapid onset of the following symptoms within a two hour time frame. Dizziness. Strong Migraine (Firs... Read more
Rapid onset of the following symptoms within a two hour time frame. Dizziness. Strong Migraine (First ever in life time). Light Sensitivity. Vomiting for multiple hours which did not subside with reduction of migraine or food intake. Migraine was not affected in a positive way with vomiting. Episode lasted approximately seven hours. The next 24 hours symptoms included dizziness and feeling weak.
33 2021-03-22 numbness Pt received the vaccination at 1006 22MAR2021. Pt reports having numbness of the left side of the fa... Read more
Pt received the vaccination at 1006 22MAR2021. Pt reports having numbness of the left side of the face and back-left side of the tongue at approximately 1830-1900. Denies swallowing or facial muscle movement problems. No known allergies, no prior vaccination reactions.
33 2021-03-23 pain in extremity Roughly three hours after the vaccination, my arm started hurting. There was minor swelling. The sw... Read more
Roughly three hours after the vaccination, my arm started hurting. There was minor swelling. The swelling has gone away, but the pain persists. The evening of the vaccination, I experienced severe fatigue and tiredness. I slept 14 hours that night and after waking up, I'm tired and lethargic and my arm still hurts. I missed work today (Wednesday 3/24/21) due to the pain and fatigue.
33 2021-03-23 seizure Systemic: Seizure-Mild, Additional Details: Minor seizure lasted only briefly. Patient seemed unconc... Read more
Systemic: Seizure-Mild, Additional Details: Minor seizure lasted only briefly. Patient seemed unconcerned afterwards and informed pharmacy staff that he goes through this outcome after getting any type of vaccine.
33 2021-03-23 unresponsive to stimuli, flushing 10 to 15 minutes after receiving the vaccination. The patient reported to a pharmacy technician the... Read more
10 to 15 minutes after receiving the vaccination. The patient reported to a pharmacy technician they were feeling unwell. As the patient went to sit down they fainted. Patient was unresponsive for roughly a minute exhibiting tensed arm and neck muscles. Muscles also contracted several times during the episode. Patients eyes were open during the episode but they could not be coaxed to speak signal or blink. Additional patient symptomology as follows: elevated pulse, constricted pupils, flushing/redness in the face & neck. For this reason, medical staff called 911. Patient became responsive and reported losing consciousness and having no recollection of majority of the event. Upon arrival EMT's took over patient care. Patient left with EMT's
33 2021-03-25 flushing Dizziness Flushed, sweaty, heart racing Narrative: outpatient RRT called at0904 to the auditorium. ... Read more
Dizziness Flushed, sweaty, heart racing Narrative: outpatient RRT called at0904 to the auditorium. pt stated ~15min after vaccine administration she felt a tingle in her throat for a few seconds that quickly resolved, dizzy, and felt her heart was racing. observing RN inauditorium gave 25mg benedryl IM shortly after, she then felt tired and like she was 'drunk'. no alcohol on board per pt. vaccine was second dose and administered in left deltoid. denies f/c/n/v/d/CP/SOB, is able to breathe clearly and swallow secretions. Other Relevant History:
33 2021-03-25 seizure Systemic: Seizure-Mild, Additional Details: Patient had a minor shock lasting briefly within 15 minu... Read more
Systemic: Seizure-Mild, Additional Details: Patient had a minor shock lasting briefly within 15 minutes of vaccine administration. 911 was called and the Fire Department arrived, but he had already recovered at that point and refused service. He informed the pharmacy staff that this is a regular occurrence every time he receives a vaccine.
33 2021-03-29 numbness Left side of my face when numb, not limp, just numb. Kinda like when the numbing medication at a den... Read more
Left side of my face when numb, not limp, just numb. Kinda like when the numbing medication at a dentist office is wearing off. This started happening shortly after I got the shot, but by the next morning it was gone.
33 2021-03-29 seizure Patient fell backwards from urinal in men's bathroom. Hit his head and sufferred a seizure. Ambulanc... Read more
Patient fell backwards from urinal in men's bathroom. Hit his head and sufferred a seizure. Ambulance was called. Witness to the incident.
33 2021-03-31 cold sweat got my Pfizer COVID vaccine March 30th 2021 @ 9am. 39 hours after my 1st Pfizer COVID vaccine, I wo... Read more
got my Pfizer COVID vaccine March 30th 2021 @ 9am. 39 hours after my 1st Pfizer COVID vaccine, I woke up at 1 am from bed on April 1. I dry heaved and threw up from 1-5 am. Horrible headache, knees and ankles weak and sore, no appetite, chills, cold sweats, nausea, April 1, 6 am-5 pm I napped with chills and cold sweats.
33 2021-03-31 flushing Diaphoresis. Flushing. Blood pressure from 133/94 to 136/95 then 144/99. Pulse from 72 to 67 to 67
33 2021-03-31 muscle spasms Full body muscle spasms. Could not stop them for a good 30 minutes. Made it hard to breathe. This ha... Read more
Full body muscle spasms. Could not stop them for a good 30 minutes. Made it hard to breathe. This happened multiple times over the course of a couple hours for prolonged periods. It was like having a shiver from being cold but 100x worse.
33 2021-03-31 night sweats Extreme fatigue, flu like symptoms, fever, night sweats, nausea
33 2021-03-31 pain in extremity, tremor A few hours after receiving vaccine I developed high fever (not certain about the temperature) chill... Read more
A few hours after receiving vaccine I developed high fever (not certain about the temperature) chills, shakes, sweating, headache, extremely sore arm. It felt like I had a severe case of the flu. About 24 hours later, with the assistance of Acetaminophen, the symptoms seemed to have lessened. I am afraid the same thing will happen tonight again. Upon your follow up, I will advise.
33 2021-04-01 weakness Complete lack of energy. Unable to work. Note: Patient received second COVID vaccine 14 days after f... Read more
Complete lack of energy. Unable to work. Note: Patient received second COVID vaccine 14 days after first vaccine instead of 21 days.
33 2021-04-01 pain in extremity, tenderness Soreness, chills, 100-101 degree tempature, nausea, vomiting, prolonged diarrhea, burping, tiredness... Read more
Soreness, chills, 100-101 degree tempature, nausea, vomiting, prolonged diarrhea, burping, tiredness. Soreness throughout body and joints Sunday morning. Tiredness and chills started Sunday afternoon. Temperature and nausea started Sunday night. Vomiting in the night of Sunday and part of morning Monday. Temperature and chills worsening throughout Monday morning and afternoon. Diarrhea started Monday evening and continued until Wednesday morning. Chills and temperature continued throughout all Monday and Tuesday ending in the night. Tiredness continued on through Wednesday. Soreness and tenderness in left arm continued until late Wednesday. Prolonged oral gas (burping) started Sunday early morning and contenued until Wednesday morning.
33 2021-04-02 flushing dizziness flush sweating
33 2021-04-03 cold extremities, cold sweat 9:30pm- Muscle fatigue/soreness. 10:30pm- hands and feet extremely cold. Only way to get warm was ho... Read more
9:30pm- Muscle fatigue/soreness. 10:30pm- hands and feet extremely cold. Only way to get warm was hot water. 11pm-7:30am 4/4/21- fever, chills, repeat of hands and feet cold. 7:30-ongoing- Clammy skin, muscle weakness, exhaustion.
33 2021-04-05 cold sweat Loss or consciousness about 30 seconds, recovered feeling clammy and ?out of it? Felt better after ... Read more
Loss or consciousness about 30 seconds, recovered feeling clammy and ?out of it? Felt better after reclining and putting feet up
33 2021-04-05 tremor, tingling Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: f... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: I gave patient orange juice and crackers after reported. Took blood pressure, slightly elevated. after 1/2 hour patient feeling better but still tingling, offered to call 911, but mother, who was in attendance, said was going home. She also told me she had the same response when she received same vaccine. Mother is contacting doctor to determine is pt should take 2nd dose. Offered benadryl, but mother refused.
33 2021-04-06 cold sweat Patient complained of bieng nauseaus, clamy, and sweaty. Onsite EMS was called vitals BP 123/69 ... Read more
Patient complained of bieng nauseaus, clamy, and sweaty. Onsite EMS was called vitals BP 123/69 HR 59 100% O2. He said he hadn't eaten anything yet. He was offered graham crackers and water, he refused both. felt better and was released home.
33 2021-04-06 flushing, cold sweat Client received the COVID vaccine (Pfizer, dose #1, lot# EW0150) at 1215. EMT observed the client to... Read more
Client received the COVID vaccine (Pfizer, dose #1, lot# EW0150) at 1215. EMT observed the client to be clammy and sweaty, and she and RN responded at 1230. The client was sitting in the chair, face flushed and diaphoretic, reported feeling dizzy. The client stated he has no allergies, and his only medical condition is ankylosing spondylitis. His only medication is cosentyx. The client's vital signs were as follows: blood pressure of 139/83, respiratory rate of 20, heart rate of 106, and pulse oximeter reading of 97%. The client's pupils were equal and reactive to light. The client was offered water. At 1235, repeat vital signs were as follows: blood pressure of 130/90, heart rate of 103, and pulse oximeter reading of 98%. At 1240, the client started to cough and complained of intermittent shortness of breath. The client refused benadryl at that time. Breath sounds on the client were clear, no swelling or edema observed around the mouth or tongue. At 1245, 9-1-1 was called. At 1245, EMS assumed care. Client transported to Hospital.
33 2021-04-06 grand mal seizure Grand mal seizure, 2:30 a.m. , second night after injection, 3-5 minutes.
33 2021-04-07 cold sweat, feeling hot 0933: few minutes after receiving vaccine, c/o dizziness, chest tightness, feeling hot, starting to ... Read more
0933: few minutes after receiving vaccine, c/o dizziness, chest tightness, feeling hot, starting to black out. patient then experienced syncopal episode, feeling clammy, while being placed on stretcher, thready pulse noted. regained counsciousness once laying flat on stretcher. arriving to obs 0936: bp 111/71 hr 68 rr 18 sats 96%. patient arousable and reports feeling better. 0941: bp 110/69 hr 74 rr 18 sats 98%. patient able to sit up with ease, reports feeling back to baseline 0945: bp 120/86 hr 78 rr 18 sats 98% on ra. no further s/s of complications. departed to personal vehicle 0956.
33 2021-04-07 facial paralysis facial paralysis/facial drooping/facial palsy/eyes started drooping and then mouth started drooping;... Read more
facial paralysis/facial drooping/facial palsy/eyes started drooping and then mouth started drooping; strange feelings in face; This is a spontaneous report received from a Pfizer sponsored program.This contactable consumer patient himself and a contactable physician psychologist, (parent of patient reported) that a 33-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm on 21Mar2021 16:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. On 21Mar2021 at 07:30 PM, after receiving his first dose, he began noticing facial drooping, which began to intensify, on the right side. He was advised by a medical professional to immediately call an ambulance and he was then taken to an emergency room where received a CT scan and full bloodwork on Mar2021. Luckily, the facial palsy began to subside and he was able to return home after the test results came back and a stroke was ruled out - it was stated that this was some kind of immuno-reaction to the vaccine. He still felt as though his face was still not 100% back to normal and still felt a bit droopy (noticeable in the mirror) yet it does feel better than on 21Mar2021 evening. Patient had a nasal swab on 22Mar2021 with negative result. One of the reporters is a psychologist and reported that her son received Pfizer-BioNTech COVID-19 Vaccine. Psychologist asking about risk of Bell's palsy, incidence, and outcomes and if these patients received their second dose of the Pfizer-BioNTech COVID-19 Vaccine. She read about 7 cases of Bell's palsy in a Dec2020 article in the [Redacted], 4 of them on the Pfizer vaccine. The reporter further clarified and described that at 6pm (2 hours after dose), patient reported he felt fine and was happy he got the vaccine; but then sometime after that, he reported "strange feelings in face" and then eyes started drooping and then mouth started drooping, all on right side of face. They called the university clinic and was instructed to go to ER. Brain scans and blood work were done; they ruled out stroke and said it was a possible reaction to the vaccine. He was discharged at midnight and by then, paralysis was 80-85% resolved. He is an otherwise very healthy young man. The psychologist wanted to know the efficacy after just one dose and stated that a friend suggested to perhaps not get second dose and consider getting a dose of the non mRNA vaccine like Johnson and Johnson. The outcome of the event was recovering. Information on Lot/Batch number has been requested.
33 2021-04-07 flushing, feeling hot, feeling cold, tingling Right arm became weak, tingly and cold. Pt became sweaty, flushed and felt a warm sensation come ove... Read more
Right arm became weak, tingly and cold. Pt became sweaty, flushed and felt a warm sensation come over body. Became dizzy and lightheaded. Pt assisted to floor and then to stretcher by staff. Arrived to med obs with all symptoms resolved except right arm weakness and tingling. Right arm warm to touch. Bilateral hand grips equal. No arm drift noted. No reaction noted at vaccine site. Vitals remained stable during evaluation. Initial vitals as follows; BP 127/78 HR 57 RR 14 spo2 99%. Final vitals as follows; BP 126/80 HR 48 RR 14 spo2 99%. Pt instructed to follow up with physician if symptoms don't resolve within an hour or symptoms get worse. Pt left facility by self @ 1526.
33 2021-04-07 numbness Right arm went numb for about 5 minutes.
33 2021-04-08 cold sweat He was feeling restless, clammy, and dizzy and appeared pale during his 15-minute waiting period aft... Read more
He was feeling restless, clammy, and dizzy and appeared pale during his 15-minute waiting period after vaccine administration. I had him lie down on the floor with his feet up for about 10 minutes until he felt confident to sit in the chair for another 10 minutes or so. As he was lying on the floor, We brought him a bottle of water. His color came back shortly after lying down on the floor. He stated that he has previously had panic attacks after shots, blood draws, etc. He stated he was no longer dizzy when he stood up to leave.
33 2021-04-08 pain in extremity Soreness in arm getting progressively stronger until 11:00am. Mild headache throughout second day. G... Read more
Soreness in arm getting progressively stronger until 11:00am. Mild headache throughout second day. General fatigue
33 2021-04-08 tenderness Severe swelling; tenderness and soreness under the left armpit; Severe soreness at injection site (o... Read more
Severe swelling; tenderness and soreness under the left armpit; Severe soreness at injection site (outer left arm); Severe soreness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 1:15 pm (Batch/Lot Number: EL0982) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included Nature's Way Alive Max3 Daily multivitamin. The patient had previously received first dose of bnt162b2 (BNT162B2) on 29-JAN-2021 at 1:15 pm (Lot number: EL3246) for covid-19 immunisation. On 19Feb2021 at 12:00 pm the patient experienced severe swelling, tenderness and soreness under the left armpit, severe soreness and fatigue .The treatment for events was unknown. The action taken in response to the event(s) for bnt162b2 was not applicable. Outcome of events was unknown.
33 2021-04-08 unresponsive to stimuli, flushing, feeling of insects crawling on skin, cold sweat Patient presented for his first vaccine dose. He later stated he felt a sensation of something movin... Read more
Patient presented for his first vaccine dose. He later stated he felt a sensation of something moving through his arm after vaccine administered, then states he felt some increased anxiety, followed by cold sweats, and then lost consciousness. He was noted to be unresponsive, initially with brief period of apnea, and was unresponsive to sternal rub by vaccine administration staff. He was placed into a reclined position in the driver seat of his vehicle. He regained consciousness within a minute, and was normally responsive but with pale color noted to face and chest, diaphoresis, and thready pulse with bradycardia, HR 43. Difficult to auscultate HR and breath sounds clear but shallow. EMS responded promptly and assisted with evaluation, with initial BP 80/50, SpO2 97%. Patient became less responsive and started to lose consciousness again, but responded to questioning, then lost consciousness again. His feet were placed on the dashboard to elevate them, and he quickly regained consciousness, pulse improved to HR 86, and repeat BP after a few minutes was 140/76. Oxygen saturations briefly dipped to 90% then rebounded to 100%. He improved quickly, was normally responsive and able to drink orange juice. He had pale clammy skin on the face, neck and hands, and some facial flushing. Patient was monitored for several minutes, had improvement in symptoms, and refused transport by stretcher to the ambulance. He was able to walk to the passenger side of his vehicle and was driven out of the vaccination facility and further monitored. Blood glucose noted to be 96, EKG normal with sinus rhythm, no acute ST or T wave changes or other acute abnormality. Patient was offered transport to the hospital for further evaluation, but he declined. Symptoms resolved completely, he was monitored for resolution of symptoms. He reported prior similar symptoms after a hand laceration at work and after a dental visit. Risks discussed, prevention measures for second dose discussed. Encouraged follow up with PCP given recurrent vasovagal syncope. No signs of allergy noted.
33 2021-04-09 feeling hot headache; felt warm in the head; aches, particularly in my lower back; chills; I had pain at the inj... Read more
headache; felt warm in the head; aches, particularly in my lower back; chills; I had pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Right on 09Feb2021 at 04:30, at a single dose for covid-19 immunization. The patient medical history and concomitant medications were none. The patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 19Jan2021 04:30 at single dose for covid-19 immunization. The patient did not receive any other vaccines in 4 weeks. The patient experienced pain at the injection site on 10Feb2021, after receiving the second dose and would compare the feeling to a bad bruise approximately after 17 hours the patient had chills and approximately after 19 hours the patient started to develop aches, particularly in lower back. The aches were not severe and were more of a nuisance. Approximately after 21 hours the patient, developed a headache and felt warm in the head. The headache slowed her down and was bothersome for the remainder of the day. The headache was almost completely gone when she woke up the next day. My head no longer felt warm when I woke up. Events were not treated. All the events were recovered when she wok up next day.
33 2021-04-11 cold sweat Patient fainted 10 minutes after receiving his first dose of the Covid vaccine. He was sweating prof... Read more
Patient fainted 10 minutes after receiving his first dose of the Covid vaccine. He was sweating profusely and very clammy. We gave him an ice pack and monitored him for 30 minutes after. His blood pressure was 90/60 a few minutes after the episode but then it came up to 124/84 a few minutes later. His eyes were dilated and we were concerned about a possible concussion from the fall so EMS came and evaluated him. They cleared him to go home.
33 2021-04-12 pain in extremity Day 1 (4/5/21) was a Monday and I felt okay. Tuesday I felt okay. Wednesday and on I?ve had mild hea... Read more
Day 1 (4/5/21) was a Monday and I felt okay. Tuesday I felt okay. Wednesday and on I?ve had mild headaches and fatigue. Today (4/13/21) I had strong fatigue and needed to rest after work for at least an hour. In addition, last night (4/12/21) I experienced slight pain in my lower to middle right leg. It went away after a while. I?m a kidney transplant patient so there are many variables to take into consideration.
33 2021-04-13 flushing Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
33 2021-04-13 hot flush, muscle twitching Twitching at injection site (left arm) and feeling of flush ness as if I was blushing but only in my... Read more
Twitching at injection site (left arm) and feeling of flush ness as if I was blushing but only in my chest and left arm.
33 2021-04-14 slurring Feeling chest pounding, anxiety, slurred speech, dizziness, sweaty
33 2021-04-14 numbness Approximately 30 minutes post injection patient had numbness in vaccinated arm which over the course... Read more
Approximately 30 minutes post injection patient had numbness in vaccinated arm which over the course of time moved to the left leg and eventually the right leg as well. Pharmacy was made aware of this problem at second vaccine appointment. Patient was instructed to contact Dr before receiving second dose.
33 2021-04-14 numbness 33 y/o male, no past medical history, who presents with left ear and left upper and lower extremity ... Read more
33 y/o male, no past medical history, who presents with left ear and left upper and lower extremity numbness. Negative Stroke Scale. Vaccination site was the left deltoid. NP and Paramedics at patients side. Patient vitals within normal limits. Patient placed in Trendelenburg position. Patient asked to lay on his right side to see if the feeling would travel to his right side. Patient states that numbness was getting better and he thinks that it was going to the right side. Patient denied headache, no facial droop noted, no facial asymmetry present. Patient symptoms persisted for over 40 mins so Fire Rescue was called. Patient was transported to hospital. -------------------END.
33 2021-04-14 seizure Patient reported feeling dizzy after vaccination during observation period. Patient was placed in w... Read more
Patient reported feeling dizzy after vaccination during observation period. Patient was placed in wheelchair and brought to a private observation area. During transport, patient seized and had syncopal episode in wheelchair twice. EMS was notified and arrived within one minute. Vitals were taken and patient regained consciousness. Initial blood pressure in supine potion was 92/62 with a heart rate of 58. Patient was alert and oriented times three, stable. Orthostatic blood pressure was taken. Patient was diaphoretic. Patient's wife was in tent with patient. Patient's blood pressure on recheck was 122/73, 132/78 with heart rate 75, 76. Patient agreed to have wife drive patient home. Patient to follow up with PCM if patient has recurring symptoms. ER precautions given. Patient agreed with plan.
33 2021-04-14 tremor Rec'd covid vaccine dose 1 @ 1430. c/o nausea, dizzy, tachy @1440. taken from theater chair to gurne... Read more
Rec'd covid vaccine dose 1 @ 1430. c/o nausea, dizzy, tachy @1440. taken from theater chair to gurney@1443 HR 114 Left BP 134/94 sats 94% on RA. 1446 given apple juice box, fruit snacks and water LEFT BP 136/94 HR 104 sats 94%increased drowsiness, bilateral arm tremor, nauseous, able to answer all questions, aaox3 however drifting to sleep eyes closed often during conversation. pt stated takes depakote, chart review revealed depakote, cogen, plenate with h/o schizophrenia. 1459 BP LEFT while sitting up on gurneu 129/94 HR 120 RA 96% no longer dizzy or nauseous. 1502 sitting up, talking, recovered. 1504 LEFT BP 113/100 RA 94% ambulated to parking lot without assistance to depart in handivan.
33 2021-04-15 weakness Patient weakness unable to diagnosis specific cause. Onsite EMS was called vitals BP 110/60 99% O2 H... Read more
Patient weakness unable to diagnosis specific cause. Onsite EMS was called vitals BP 110/60 99% O2 HR 86. Patient refused evaluation or care without transport, released agianst medical adivse.
33 2021-04-15 bell's palsy Bell's palsy
33 2021-04-15 feeling hot, numbness, feeling jittery, tingling 3 days after the vaccine I started feeling extremely jittery with numbness in my arms and legs. My h... Read more
3 days after the vaccine I started feeling extremely jittery with numbness in my arms and legs. My heart rate increased and I was finding it very difficult to stay calm or focused. This has been persistent since. Body seems warmer than usual and numbness/tingling sensation is still an issue.
33 2021-04-15 unresponsive to stimuli 1pm Pt reports not feeling well. Pale and diaporetic sitting in chair in OBS area. HX HTN No PSH and... Read more
1pm Pt reports not feeling well. Pale and diaporetic sitting in chair in OBS area. HX HTN No PSH and po BB at night. Verbal and expressive. Unresponsive for appx 5 sec and regained without assistance. EMS activated. VS brady 106/63 P 48 Pt reported did not eat, just closed on home and going to close on another home at 2 pm Pt wife is preg and due next month. BP 127/83 verbal, tolerated water and no deficits noted. Amb to personal car. Wife driving and instructed to let medical know next dose to lay down prior to vaccination. No direct adverse reaction noted to the vaccine, FNP
33 2021-04-17 tingling, numbness Within 2 minutes of vaccine i became very light headed and needed to lay down and was sweating. This... Read more
Within 2 minutes of vaccine i became very light headed and needed to lay down and was sweating. This is common with me with any vaccine. Within 24 hours severe shortness of breath and severe chest pains. Went to 2 urgent cares. Was prescribed Prednisone and a Inhaler. Both did nothing. Symptoms got worse. went to my primary doctor who ordered a chest X ray which came back good. and a EKG which came back with a slight issue and referred me to a cardiologist next month. Was sent home to recover. Pain and shortness of breath got worse. Within a week after that i got severe headaches and the left side of my head arm and leg began to get numb and tingle sensation which lasted about 48 hours. About 2 weeks after vaccine i began to improve. Chest pain started to go away and my shortness of breath as well. As of today 4-18-2021 no chest pain, and shortness of breath still comes and goes but nothing compared to weeks before.
33 2021-04-17 tremor Syncopal event. Witnessed loss of consciousness while standing and fell forward. Did not strike he... Read more
Syncopal event. Witnessed loss of consciousness while standing and fell forward. Did not strike head. Pt breathing rapidly & upper extremities shaking. VSS except RR 26 A&Ox4. 911 Called given LOC for further evaluation. Transported to ED.
33 2021-04-18 involuntary muscle movements Jaw pain under left ear. One week after vaccination. The jaw pain comes and goes. The joint is ten... Read more
Jaw pain under left ear. One week after vaccination. The jaw pain comes and goes. The joint is tender to the touch. Hard to open moth wide and can be hard to chew
33 2021-04-18 facial paralysis left sided facial droop onset 24 hours prior, in addition patient had chest pain 48 hours prior noth... Read more
left sided facial droop onset 24 hours prior, in addition patient had chest pain 48 hours prior nothing improved chest pain however it resolved on its own; nothing improved facial droop quality of chest pain was sharp, mild intensity, facial droop symptoms have been worsening since onset
33 2021-04-18 pain in extremity arm pain, chills, body ache
33 2021-04-19 weakness started on 4/17 in the evening and lasted through 4/18 called on 4/19 still feeling weak and chills
33 2021-04-20 pain in extremity, feeling cold he feels like his throat is so raw; Second COVID-19 vaccine: sore arm; Second COVID-19 vaccine: feel... Read more
he feels like his throat is so raw; Second COVID-19 vaccine: sore arm; Second COVID-19 vaccine: feeling achy/ Her husband is still sore/achy today; Second COVID-19 vaccine: nauseous; Second COVID-19 vaccine: vomiting/ throwing up; Second COVID-19 vaccine: diarrhea; Second COVID-19 vaccine: fatigue; vomiting blood; Second COVID-19 vaccine: blood in the phlegm or just whatever he spit up / spitting up blood; Second COVID-19 vaccine: Chilly; Second COVID-19 vaccine: redness around his eyes, like under his eyelids; his pores looked red; This is a spontaneous report from a contactable consumer (wife). A 33-year-old patient (husband) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right arm on 05Apr2021 15:40 (Lot Number: ER8734) at single dose for COVID-19 immunization. Medical history included atopic dermatitis. Concomitant medication included dupilumab (DUPIXENT), an injection that patient takes every other week to control his atopic dermatitis, he has been using this for 3 years at least. The patient previously received the first dose of BNT162B2 (Lot number: ER6207) in left shoulder on 15Mar2021 15:40, at the age of 32 years old, for COVID-19 immunization, and experienced arm sore and body aches. The patient experienced vomiting blood in Apr2021, blood in the phlegm or just whatever he spit up / spitting up blood in Apr2021, he feels like his throat is so raw on 05Apr2021, sore arm on 05Apr2021, feeling achy/ her husband is still sore/achy today on 05Apr2021, nauseous on 05Apr2021, vomiting/ throwing up on 05Apr2021, diarrhea on 05Apr2021, chilly in Apr2021, redness around his eyes, like under his eyelids; his pores looked red in Apr2021, fatigue on 05Apr2021. No treatment received for the adverse events. Outcome of the events pain in arm, ache, nauseous, erythema, fatigue was not recovered, of the other events was unknown. Clinical course as reported: Her husband got their second dose of the vaccine on 05Apr2021. Her husband was having a more severe reaction than the first time. The first time he got the vaccine his arm was sore. Last night (05Apr2021), the caller's husband was vomiting just over and over and had diarrhea, both at the same time. Wife added the thing she was worried about was that her husband was vomiting blood as well, and that her husband said it was from the phlegm, like he felt like his throat was so raw. Her husband did not really want to eat anything which she expected was normal. She was trying to give him fluids, and having him drink a little bit. Her husband had not vomited since around 4 am. And right now, he was sleeping. She did not know if she should give him medicine or take him to be seen or if this was a normal reaction to the vaccination. She did read side effects from the paper and she saw that some vomiting was expected but the blood was what caught her off guard. Around 10 o'clock last night (05Apr2021), her husband felt nauseous and went to bed. She actually fell asleep on the couch and heard her husband vomiting across the house, that was how bad the vomiting was. The vomiting started at midnight last night (05Apr2021). Her husband has been vomiting every couple of hours (2 hours), around the clock. Diarrhea had been at the same time. From her understanding, her husband had vomited at least 3 or 4 times, and had diarrhea 3 or 4 times. She kind of lost track after the 3rd time, but she had not heard him since around 4 am Her husband was still sore/achy today (06Apr2020) and was is still nauseous. She believed he was also feeling chilly. He was wrapped up in his blanket. Her husband did not have a fever, she has been checking his temperature. Wife stated no treatment yet, as she did not know what was safe. Her husband wanted to wait until he stopped vomiting because anything he put in his stomach came right back up. After the first time her husband was done throwing up, and was only dry heaving, he started to like kind of spit. When he would gargle or spit, there was blood in the phlegm or just whatever he spit up. The first time the wife went to check on him, she saw him spitting up blood. It was not like his vomit was red with blood in it, it was just the after effects, so she thought she should call and report this. Each time he has vomited, there was still that spit up of blood afterwards. The patient himself clarified the vomiting was last around 4 am (06Apr2020), give or take, and the last stool/bout of diarrhea was around 7 am (06Apr2020). He was still feeling nauseous and fatigued. He added that after the first time he vomited and the couple times he checked later on, he looked in the mirror and saw that there was this redness around his eyes, like under his eyelids. He adds it was red, it wasn't like splotchy, but it was like his pores looked red, like pinpoints. The patient clarified that the fatigue and achiness probably started around the first time he vomited, and that was still hanging around. The wife stated this was better than him getting Covid. Wife added what she was trying to see was if she should take her husband to the hospital or not. She did not want to wait too long, but if this was something that was a side effect that was expected, then her husband could just sleep it off.
33 2021-04-20 pain in extremity Sore arm and fatigue with second dose.
33 2021-04-20 tingling 5 MINUTES POST INJECTION : TONGUE STARTS TINGLING . SWEELING GLANDS IN THROAT . TOOK DIPHENYDRAMINE ... Read more
5 MINUTES POST INJECTION : TONGUE STARTS TINGLING . SWEELING GLANDS IN THROAT . TOOK DIPHENYDRAMINE 10MINUTES LATER : BP 143/90 - THROAT STILL SWOLLEN - ARM TINGLING MBUT TONGUE IS BETTER
33 2021-04-20 unresponsive to stimuli, tremor, flushing Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Additional Details: Patient passed out about 3 minutes after receiving injection. He experienced mild to moderate trembling and became unresponive for about a minute. I contacted 911 and they sent emergency response. Patient came to but was still lethargic and confused. First responders gave patient oxygen for several minutes, took vitals. Patient felt better after oxygen and declined to be taken to hospital. I monitored him for an additional 15 minutes after first responders left. He felt safe to drive home.
33 2021-04-21 weakness Fever dizziness pounding headache body aches, weak lethargic
33 2021-04-21 cold sweat, seizure PT STATES FELT DIZZY THEN HAD SEIZURE LASTING 3-4 MINUTES LONG NOTED CODE CALLED TRANSFERRED TO ER A... Read more
PT STATES FELT DIZZY THEN HAD SEIZURE LASTING 3-4 MINUTES LONG NOTED CODE CALLED TRANSFERRED TO ER AT THIS TIME AWAKE AND ALERT , COLOR PALE COOL AND WET.
33 2021-04-21 cold sweat 33 year old male c/o dizziness post first pfizer vaccination at 1330 He became diaphoretic and clam... Read more
33 year old male c/o dizziness post first pfizer vaccination at 1330 He became diaphoretic and clammy 1330 VS 77/49 44 16. 99% O2 SAT ON RA. A+OX3 THE WHOLE TIME. PLACED IN SUPINE POSITIION DIZZINESS RESOLVED WITHIN 30 SECONDS. F/U VS AT 1335 112/72 61 REMAINED SUPINE FOR FIVE MINUTES AND THEN SAT UP AND THEN STOOD UP VS THEREAFTER OF 113/73 68 20 AND PATIENT REPORTED BEING ASYMPTOMIC. AMBULATED TO BR WITH STEADY GAIT, DENIED ANY SYMPTOMS . DRANK TWO BOTTLES OF WATER (16.9 OUNCES EACH) AND ONE BAG OF FRITOS. STEADY GAIT MAEW, DENIES ANY SYMPTOMS AND STATED HE WAS ABLE TO DRIVE HIMSELF HOME. ADVISED TO WAIT 30 TO 60 SECONDS BETWEEN ANY POSTURAL CHANGES. REPORTED PREVIOUS VASOVAGUEL EPISODES X 4 IN THE PAST. REPORTED TAKING NO MEDICATIONS AND NO ALLERGIES. PATIENT ADVISED TO F/U WITH PCP AS NEEDED AND/OR 911 AS NEEDED AND RECORD 3 OR 4 SETS OF VS PRIOR TO NEXT VACCINATION FOR COMPARISION. HE WILL ALSO CHECK IN WITH OBSERVATION NURSE PRIOR TO THE VACCINATION. (SITE SUPERVISOR) INFORMED
33 2021-04-21 feeling hot While sitting in observing unit, he feels his breathing got heavier and feels room get hot. Denies c... Read more
While sitting in observing unit, he feels his breathing got heavier and feels room get hot. Denies chest pain or other signs/symptoms. History of Asthma. Encouraged to use his inhaler and take some deep breath. Improvement.
33 2021-04-21 pain in extremity Arm pain, headache, chills, fever, fatigue
33 2021-04-21 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: The patient fainted after vaccine administration, came to after about 3 seconds. Offered snacks and water. Pt's wife was contacted and she is coming to the store to drive him home. After resting for 10 minutes, pt reported feeling fine
33 2021-04-22 cold sweat Approx. 5 min. after vaccination client blew his car horn. EMS responded. Client cool, clammy, pal... Read more
Approx. 5 min. after vaccination client blew his car horn. EMS responded. Client cool, clammy, pale, stated that he felt that he was passing out. Vital signs checked B/P 90/40, P 50, EMS provided care, emotional support. Vital signs rechecked B/P 100/60, client reported that he felt "better but foggy." EMS provided Gatorade. Monitored for an additional 15 min. Reported that he felt better. Declined further observation or transport to ER. Encouraged to follow up with PCP or emergency room if needed. Verbalized understanding.
33 2021-04-23 numbness Right eye twitching , chest pain , left arm numbness
33 2021-04-24 flushing Flushing/sweating. BPs 93/57 (pulse 62), 103/55 (pulse 56). Rest and hydration recommended.
33 2021-04-24 tingling, numbness Felt like was fainting; Five to ten minutes after receiving the first dose I started feeling dizzy; ... Read more
Felt like was fainting; Five to ten minutes after receiving the first dose I started feeling dizzy; numb (tingling) in my fingers.; numb (tingling) in my fingers.; I also started to sweat; my BP fell when the nurse checked.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 06Apr2021 12:45 (Lot Number: ER8737) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks or in two weeks. There was no known allergies. The patient has no Covid prior vaccination and has no Covid tested post vaccination. After receiving the first dose, on 06Apr2021 13:00, the patient started feeling dizzy and numb (tingling) in his fingers. Felt like him was fainting. He also started to sweat and his BP fell when the nurse checked. The patient did not have a full breakfast or lunch before getting the dose. The patient had coffee in the morning with some dates and later had two oranges and a Kind Nut Bar. Drank some water and juice after the dizziness subsided. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken as a result of all the events. The outcome of events was resolved on unknown date.
33 2021-04-25 weakness Fever, chills, chest pain, muscle aches, severe headache, nausea, loss of energy. All symptoms laste... Read more
Fever, chills, chest pain, muscle aches, severe headache, nausea, loss of energy. All symptoms lasted for 3-4 hours with chest pain, muscle aches, headache, and loss of energy continuing into the next day.
33 2021-04-25 bell's palsy Bell's Palsy
33 2021-04-26 flushing PATIENT ARRIVED FOR HIS 2ND DOSE OF PFIZER. (1ST DOSE GIVEN 4/6/21, WITHOUT ANY REACTIONS NOTED). N... Read more
PATIENT ARRIVED FOR HIS 2ND DOSE OF PFIZER. (1ST DOSE GIVEN 4/6/21, WITHOUT ANY REACTIONS NOTED). NURSE SCREENED PATIENT AND FORM COMPLETED WITHOUT ANY NOTED REACTIONS OR REASONS NOTED TO HOLD VACCINE. INTERVIEW WITH PT WHO SAID HIS LEFT ARM STARTED TO CRAMP BEFORE THE SHOT WHEN HE WAS REMOVING HIS SHIRT. PT RECEIVED HIS PFIZER VACCINE AT 1205PM, THEN TO 15MIN WAITING. HE SAID HE FELT FLUSHED, AND SEEN SPOTS. ASSISTED BY EMERGENCY PERSONEL WITH VS TAKEN. EP SAID THE PT WAS DIAPHORETIC AND PALE WHEN HE MADE IT TO THE CAR AT 1215 AND CALLED THE AMBULANCE MONITORED EKG BY EP AND ASSESSED BY THE AMBULANCE PERSONEL. PT REFUSED TO GO TO THE ER, SAID WOULD GO TO HIS PRIMARY PHYSICIAN WITH HIS WIFE, WHO WAS PRESENT AND DRIVING THE CAR. LEFT WITHOUT ANY ACUTE SYMPTOMS AND SAID WAS FEELING BETTER.
33 2021-04-26 tingling, cold sweat 30 seconds after injection felt clammy, lightheaded and had tingling fingers. Still symptomatic at ... Read more
30 seconds after injection felt clammy, lightheaded and had tingling fingers. Still symptomatic at 15 minutes post injection but symptoms improving. Light headedness resolved after 10 minutes.
33 2021-04-27 weakness even to the point of near blindness; suddenly begin to sweat profusely; feeling weak/felt weak; naus... Read more
even to the point of near blindness; suddenly begin to sweat profusely; feeling weak/felt weak; nauseous; my vision becomes extremely blurry; spent much of that time in the bathroom with diarrhea; This is a spontaneous report from a contactable consumer. A 33-year-old male patient received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 31Mar2021 at 13:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Seasonal allergies (trees, grass) and related fruits (apples/cherries/peaches). Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient reported "Received the shot and waited in the parking lot for the 15 minutes. No negative effects whatsoever during the 15 minutes, and I was cleared to leave. As I am driving out of the parking lot, suddenly begin to sweat profusely, feeling weak/nauseous, and my vision becomes extremely blurry, even to the point of near blindness. I stopped the car and sat for about 30 seconds/1 minute until my vision returned sufficiently to drive back to the waiting area where I requested water. I immediately felt better with the water, and the staff also gave me benadryl although I don't think it had any impact. I felt weak for an additional 30 minutes or so and spent much of that time in the bathroom with diarrhea. I felt fine to drive after this 30 minutes and have had no side effects since." Therapeutic measures were taken as a result of even to the point of near blindness, suddenly begin to sweat profusely, feeling weak/felt weak, nauseous and my vision becomes extremely blurry. No treatment was reported for the event spent much of that time in the bathroom with diarrhea. Outcome of the events was recovered on 31Mar2021.
33 2021-04-27 numbness Patient reported chest muscle tightness on the left side, numbess in the left shoulder and tricep. T... Read more
Patient reported chest muscle tightness on the left side, numbess in the left shoulder and tricep. This was reported about 50 minutes after receiving the vaccine
33 2021-04-27 pain in extremity Sore arm Fever Sore throat
33 2021-04-28 weakness Client complained of dizziness and weakness. Fire Rescue first responded. Client vitals all within ... Read more
Client complained of dizziness and weakness. Fire Rescue first responded. Client vitals all within normal limits. Client showed symptoms of paleness and diaphoresis but recovered by the time of release. Client was released to home at 11:30am. No further treatment needed as per Fire Rescue.
33 2021-04-28 numbness, tingling Patient was seen at ER for left sided facial numbness at 2126 on 22 MAR. Patient was diagnosed w/ pa... Read more
Patient was seen at ER for left sided facial numbness at 2126 on 22 MAR. Patient was diagnosed w/ paresthesia and discharged at 2200 on 22 MAR.
33 2021-04-28 pain in extremity ? Arm pain all the way down to fingers all week, and it turned purple ? Little red dots, like a sub... Read more
? Arm pain all the way down to fingers all week, and it turned purple ? Little red dots, like a subtle rash, at injection site ? Passed 4/16; woke up with very bloody nose which was not from hitting anything because he slumped forward (He is not dehydrated) ? Very cold and his hands turned blue; shivering
33 2021-04-28 tremor The patient began feeling light-headed and diaphoretic immediately after vaccine administration. He ... Read more
The patient began feeling light-headed and diaphoretic immediately after vaccine administration. He was taken by wheelchair to a medical exam table to recline, with feet elevated on pillows. He stated he had not had anything to eat that morning or the evening prior. He was offered juice, and would take sips if it was held to his mouth, however did not want to eat any crackers. He was not verbal, answering questions by shaking his head yes or now only. Unsure if he remained oriented. He was also noted to have a brief syncopal episode. He was noted to be shaky and anxious. He complained of lethargy and was unable to bear weight/walk. His vitals upon arriving at the exam table were: BP 110/64 HR 45 SpO2 97% It was determined by RN that he may be hypoglycemic. No glucometer was available. She stated he was not able to tell them if he was diabetic. She decided to administer 1mg glucagon subcutaneously. He also continued sipping on apple juice. His vitals were repeated five minutes later and at that time were: 110/82 HR 84 SpO2 96% Ten minutes after this: 122/80 HR 74 SpO2 95%. This was now 1045. He was complaining of his head spinning when he tried to sit up and remained shaky. He was unable to stand or walk independently. At this time it was recommended that he go to the emergency room or urgent care. He denied an ambulance, but stated his mother could come pick him up and take him to the emergency room. She was contacted, arrived at 1105. His last set of vitals remained within normal limits at 1106. He was taken by wheelchair to his mother's car.
33 2021-04-29 numbness, tingling Patient experiencing dizziness and diaphoresis immediately following vaccine. Patient reports "numbn... Read more
Patient experiencing dizziness and diaphoresis immediately following vaccine. Patient reports "numbness" in left arm for about 10 minutes, which then turned to "tingling" for 20 minutes. Patient instructed to follow up with PCP.
33 2021-04-29 tenderness, pain in extremity Very sore and tight left arm, same arm for injection, with a small lump or knot. Lump/knot is near b... Read more
Very sore and tight left arm, same arm for injection, with a small lump or knot. Lump/knot is near back/shoulder and armpit. Pain radiates from spot and is painful to touch.
33 2021-04-29 tremor POST VACCINE, PATIENT NOTED TO HAVE TREMORS, AND NEAR SYNCOPAL EPISODE. ASSISTED TO FLOOR, FEET PLAC... Read more
POST VACCINE, PATIENT NOTED TO HAVE TREMORS, AND NEAR SYNCOPAL EPISODE. ASSISTED TO FLOOR, FEET PLACED ON CHAIR, DID NOT LOSE CONSCIOUSNESS. ASSISTED TO STRETCHER, TAKEN TO OBS WITH DAD, PLACED IN TRENDELENBERG, REPORTS SLIGHT RELIEF (SPECIAL NEEDS). ALSO REPORTED NAUSEA. VSS THROUGHOUT EPISODE. ONCE S/S IMPROVED, SAT UP AND SNACK PROVIDED. ONCE S/S RESOLVED, ESCORTED VIA WC WITH FATHER TO EXIT WITH NO ISSUES AT 1245. 1140 LYING BP 110/76 HR 98 RR 22 SATS 99% RA 1200 SITTING BP 108/75 HR 90 RR 20 SATS 98% RA 1230P STANDING BP 110/72 HR 88 RR 20 SATS 99% RA
33 2021-05-01 weakness Fever,weak dizzy, sleepy, lightheaded, nauseous
33 2021-05-01 feeling cold At around 2 AM the night after the vaccine (5/1), I woke up feeling extremely cold and aching all ov... Read more
At around 2 AM the night after the vaccine (5/1), I woke up feeling extremely cold and aching all over. This lasted until around 3 AM on 5/2. I also had occasional slight headaches during the day on 5/1. After the fever symptoms went away, the were immediately replaced by: runny nose, sneezing, some coughing, a slight wheeze (only lasted from 3 AM to 4 AM), slight chest tightness, itchy mouth/tongue, and throat tightness. All of those lasted until around 11 AM on 5/2. Only a slight throat tightness remains now (noon on 5/2).
33 2021-05-01 pain in extremity Patient was given an expired vaccine that was left out from the day before. He has reported no side ... Read more
Patient was given an expired vaccine that was left out from the day before. He has reported no side effects except for a sore arm.
33 2021-05-02 numbness Started experiencing back pain around 4/23/21, then experienced numbness in the feet on 4/26, was su... Read more
Started experiencing back pain around 4/23/21, then experienced numbness in the feet on 4/26, was subsequently admitted to Medical Center on 4/28/21
33 2021-05-02 pain in extremity Pt rec'd COVID-19 vaccine at 817am. He completed his observation time and walked to his car. He star... Read more
Pt rec'd COVID-19 vaccine at 817am. He completed his observation time and walked to his car. He started feeling dizzy. Continue to drive to work and began feeling worse. Sudden onset of pain at injection site that began to shoot into his neck and down into left lower extremity. He returned to the vaccine clinic. BP normal, HR 135. C/O severe left jaw, neck and left arm pain. Brief throat itching. Pain waxes and wanes. EMS notified and patient transported to for evaluation. Pt monitored in ED, treated with Benadryl, Morphine, Robaxin and discharged to home . Symptoms resolved in ED.
33 2021-05-02 tremor, weakness patient reports history of anxiety, shaking and passing out with shots. Patient reports shaking, we... Read more
patient reports history of anxiety, shaking and passing out with shots. Patient reports shaking, weak and is pale and sweaty. After lying down, patient reports symptoms resolved at 3:12pm
33 2021-05-02 tremor Pfizer-BioNTech COVID-19 Vaccine EUA: a few minutes after vaccination patient reported feeling funny... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: a few minutes after vaccination patient reported feeling funny with arm shaking then briefly experienced loss of consciousness: patient reported to return immediately back to baseline. No status epilepticus or tonic-clonic seizures witnessed. Patient immediately transported to emergency department (ED) and arrived awake with vital signs within normal ranges but refusing to answer questions. On physical exam noted to rhythmic movement of right arm but no convulsions. Administered intravenous fluids and left medically stable. Diagnosed with psychogenic non-epileptic seizure.
33 2021-05-03 tension headache Fever, chills, eventual hospital/ED visit. Consistent neck/head tightness
33 2021-05-03 unresponsive to stimuli Patient came into clinic today to receive first dose of COVID-19 Vaccine PFIZER. Pt denied any aller... Read more
Patient came into clinic today to receive first dose of COVID-19 Vaccine PFIZER. Pt denied any allergies to food or medications. Pt denied any reactions to previous vaccines. Pt denied anaphylaxis hx. Pt states no Vaccines in the last two weeks. Pt denies any COVID positive. Pt stated last fainting episode was two years ago with a blood draw and included lightheadedness, dizziness with Needle puncture. Pt stated these sx occur most with blood draws. Due to this pt was informed that wait time will be 30 minutes and we moved pt from room two to room eight to sit in adjustable chair. Pt father and pt son were present. Reaction: At 1343 pt. began to feel light headed and pt was given a bottle of water to sip which pt did. Pt began to close eyes and laid head back without responding after a few sips of water. Administered Sternal rub and pt was asked LOC question with no response just groaning. VS were taken. After VS were complete pt began to answer questions verbally (ie name of son, as well as how many children pt. has etc) and pt answered correctly, but pt. continued to have eyes closed, was pale, and diaphoretic. Dr. was informed and was made aware of Initial Set of vital signs which were within normal limits. Dr. requested that pt be laid flat. Pt was put in Supine position and was assessed by physician. Pt was responsive, but required further monitoring. Pt stayed for 30 min and Dr. requested orthostatic VS which were all within normal limits. Pt was released after Dr's final assessment. Patient stayed for 40 min total and Patient was awake an oriented x4, left with father and patient son with no further issues. Patient was advised for second COVID-19 Vaccine to notify nurse about incident so that proper measures can be taken for patient safety.
33 2021-05-04 bell's palsy Got Bells Palsy on the left side of my face.
33 2021-05-04 burning sensation Post vaccine, a few hours later he had symptoms of an upper respiratory infection. It evolved into ... Read more
Post vaccine, a few hours later he had symptoms of an upper respiratory infection. It evolved into a fairly intense headache for which he took some ibuprofen. He had chills and fevers and felt very poorly. At 7 AM on Saturday, April 24 he suffered excruciating substernal chest pain. It was a burning sensation and it was so severe he wanted to die to relieve the pain. The pain was only minimally positional and it was nonpleuritic. He drove himself to the nearest hospital and even drove through some red lights to get there more quickly. When he arrived he had ST elevation in the same leads with his early repolarization which was perhaps a millimeter or so higher than the EKG we did in February. He had both an elevation of his troponin levels which were 5.07, 6.06, 5.72 and 5.73. A CK was 195 with an MB of 41.2. He was taken to the cath lab emergently. no coronary disease.
33 2021-05-04 pain in extremity Major pain in arm and restriction in range of motion. 14+ days major diarrhea and flu like symptoms,... Read more
Major pain in arm and restriction in range of motion. 14+ days major diarrhea and flu like symptoms, tired, body ache, major headache. Has shortness of breath after second dose and went to hospital for such.
33 2021-05-05 feeling hot, pain in extremity Pt reported with the 1st dose his left arm as sore for a couple of days. Pt reported with the 2nd do... Read more
Pt reported with the 1st dose his left arm as sore for a couple of days. Pt reported with the 2nd dose, he felt feverish but sxs has subsided. On 4/29/2021, pt reported he felt sluggish and warm. Currently he reports there's a red patchy appearance at the injection site (left arm) that looks ~3 inch in diameter, and he reports he can feel a lump when placing his hand over the injection site area and it feels warm to the touch. Pt also reports that he can feel some pain with arm movements, but not at rest. Advised pt ADEs are more common with 2nd dose and ADEs usually occurs within the first 3 days and should resolve after 1-2 of onset. Recommend pt can place ice pack for 15 minutes on and 15 minutes off as need to help with the warm sensation in the left arm; can also take Ibuprofen PRN for pain. Recommend pt to stay hydrated and wear loose fitting clothing to keep the area cool. Recommend if symptoms worsen or intensify to contact MD or go to urgent care to get evaluated. Patient feeling much better, no longer has pain at injection site still has lump and redness but both have decreased in size. There were some itchiness to site which was alleviated with Benadryl, still has slight warmth when touched. Recommended to follow up with provider if symptoms worsen.
33 2021-05-06 migraine, pain in extremity First two days, high fevers, chills, migraine. Got better for three or four days then, At first, d... Read more
First two days, high fevers, chills, migraine. Got better for three or four days then, At first, dizziness and lightheadedness upon standing up, nearly fainting. Within another week, intermittent heart racing, elevated blood pressure episodes followed by headaches. By three weeks out from second dose my headaches became constant, some devolving into migraines, relegating me to my bed. Headaches are now constant, from morning until night, intermittent heart racing and bouts of light headedness are nearly every day.
33 2021-05-07 numbness, pain in extremity severe headaches; strong pain in my head, my left arm and left eye; strong pain in my head, my left ... Read more
severe headaches; strong pain in my head, my left arm and left eye; strong pain in my head, my left arm and left eye; light pressure during the morning in my head not as severe as the other days; whole body turned red; bumps; itchy; nausea; stomach ache; eyes were numb; left arm was numb; rash all over his body; chills; flu symptoms; Caller (male, age 33) spoke already to someone prior to Pfizer and gave information on his experience with the Pfizer covid vaccine. "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad. It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction. I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?" I had a side effect after the first dose of the vaccine. Should I get the second dose? e-transmitting potential duplicate AE. Caller said he didn't give PCP information to the safety agent. He did not have. Response: Spoke from EUA PI (Revised: 06 April 2021) under Post Authorization Experience Fact Sheet for Recipients and Caregivers (Revised: 06 April 2021) under section WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE? As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Request Name: Product: PFIZER-BIONTECH COVID-19 VACCINE Caller (male, age 33) spoke already to someone prior to Pfizer MI and gave information on his experience with the Pfizer covid vaccine. "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad. It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction. I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?" Caller wanted to know if his reactions could be due to him having covid before and if it was safe to get the covid vaccine after having covid infection. Response: Spoke from EUA PI (Revised: 06 April 2021) CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Spoke from attached document and emailed as requested. Request Name: Product: PFIZER-BIONTECH COVID-19 VACCINE Caller (male, age 33) spoke already to someone prior to Pfizer MI and gave information on his experience with the Pfizer covid vaccine. "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad. It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction. I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?" Caller wanted to know about delaying his second dose; information on timing of dose 2. Response: Spoke from attached document and emailed as requested. Request Name: Caller (male, age 33) spoke already to someone prior to Pfizer MI and gave information on his experience with the Pfizer covid vaccine. "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad. It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction. I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?" Caller wanted to know about using Benadryl during/after the second dose. Response: Spoke from attached document and emailed as requested. Request Name: Product: PFIZER-BIONTECH COVID-19 VACCINE Caller (male, age 33) spoke already to someone prior to Pfizer MI and gave information on his experience with the Pfizer covid vaccine. "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad. It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction. I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?" Caller wanted to know about using Tylenol or ibuprofen. Response: Due his reaction informed caller to speak with HCP or allergist regarding this. Follow-up #01 (23Apr2021): This is a follow-up spontaneous report received from a contactable reporter( patient). This male consumer (patient) reported that: Narrative case summary and further information: Patient Ethnicity: # Is the patient also the reporter? Yes Reporter type: Consumer or other non health professional Specify Consumer or other non health professional: self Dates for massive severe headache: (From: Unspecified To: Unspecified) Reporter seriousness for massive severe headache: Unspecified Dates for had chills: (From: Unspecified To: Unspecified) Reporter seriousness for had chills: Unspecified Dates for nausea: (From: Unspecified To: Unspecified) Reporter seriousness for nausea: Unspecified Dates for little bit of a stomach ache and nausea: (From: Unspecified To: Unspecified) Reporter seriousness for little bit of a stomach ache and nausea: Unspecified Is Pfizer Vaccine a Pfizer product? Yes Pfizer Vaccine manufacturer: Unspecified Dates for Pfizer Vaccine: (Start: 17 Apr 2021 Stop: Unspecified) NDC number of Pfizer Vaccine: Unknown Expiry Date of Pfizer Vaccine: Unknown Why was the patient taking Pfizer Vaccine (Verbatim): just to get vaccinated for covid Other Products: No Patient History: No Investigation Assessment: No Additional Context: Caller states he is calling about the Pfizer Vaccine and has a couple of questions in his experience with this; states he had the 1st dose of the Pfizer Vaccine on 17Apr2021 and had a really severe reaction with it and basically through the next day he had normal things that are normal but the last 5 days he has had a massive severe headache and overnight had chills then his symptom was nausea and headache and everything else; states the following four days after that he had a little bit of a stomach ache and nausea which were not as bad but had a severe headache. States he had a severe body reaction on Thursday 22Apr2021 and today he is 100 percent better. HCP information: Caller declined to provide the HCP information as he does not have that with him at this time. States he took Tylenol yesterday and the whole week which is Tylenol Extra Strength 500mg and yesterday took two tablets and on the 2nd day Sunday 18Apr2021 he took about 5 tablets the whole day and the bottle has expiry date 2024 and lot ABC207. States the emergency room gave him a steroid shot he can't find the name of and has no dosage, lot number to provide. States the emergency room gave him a medication Prednisone that he is to take for the next 5 days and is required to take it this week and it is 5mg in an orange pharmacy bottle with no lot or expiry date because it is an orange pharmacy bottle. States he took Ibuprofen 200mg with expiry date Dec2022 and lot WJ02713. States the Tylenol and Ibuprofen were the two ones that were recommended to take and he took them and the Tylenol and Ibuprofen gave him a severe headache and it was really really bad on the 5th day which was yesterday and the pressure from the headache he could feel and it was a slight pressure and was uncomfortable and the left side of his body and his eyes were numb and the left arm was numb; states after that the next day on the 5th day, he had a tight pressure in his head and in late afternoon the pain was starting to get tighter with a severe headache; states today is the 6th day. Caller states he took Tylenol again and a half hour later he had a severe body rash all over his body and had to go to the emergency room to get a steroid shot from it and the rash is not ongoing and he went to the ER yesterday and they have him the steroid shot at that time and a medication to take for the next 5 days which caller said is the Prednisone. States he had the really bad rash all over his body and it was really really red and itchy and he had bumps coming up so went to the emergency room and they could not tell if it was due to the Tylenol or part of the Pfizer Vaccine; states he had taken Tylenol a couple of times in 5 days and was fine and then took Tylenol yesterday and had the severe reaction. States he had been reading a lot and is really worried about taking the 2nd dose of the Pfizer vaccine and is debating on waiting two months before getting the 2nd one and his general practitioner can't find anything wrong and can't say the reported event is due to the Pfizer Vaccine; states a lot of people get a reaction in 6 days he has found in his reading; states his HCP has some patients that had reactions within 4 hours and not in 5 days after the vaccine and states he has no patient information or lot numbers for their vaccines to report. States he had covid in late January 2021 and that can react a lot with the Pfizer Vaccine and he understands that and does not know if this is actually an allergy of the vaccine in these few days of the last 7 days or if is the Tylenol reacting with the vaccine. States he realized that having had covid in late January could affect him a lot more with the vaccine. Caller states he only has the medication for Prednisone that he was given to take for the reaction from yesterday. VACCINE SUPPLEMENTAL FORM Patient Age at Time of Vaccination in Years: 33 Vaccine Lot Number: EW0162 Time the Vaccination Was Given: 10:35am Vaccine Lot Expire Date: unknown Anatomical Location of Administration of Pfizer vaccine considered as suspect: left arm History of all previous immunization with the Pfizer vaccine considered as suspect: This was the 1st dose of the Pfizer vaccine administered on 17Apr2021. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None Did any AE(s) require a visit to ER or MD office?: Yes, emergency room but not the HCP office. If the patient was hospitalized, how many days was the hospital stay?: n/a Prior Vaccinations (within 4 weeks): None Patient's Medical History: see additional context Family Medical History Relevant to AE(s): None Relevant Tests: None PSCC Communication: PC filed. Caller was provided with the report reference number, contact information and hours of operation for Covid Line, # option #3, Monday to Friday 8:00am to 8:00pm EST and Saturday and Sunday 9:00am to 3:00pm EST; caller was placed on hold; due to larger than normal call volumes, the caller agreed to be placed into the queue for the next available agent. Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: Vaccine Supplemental Form completed in additional context. Caller states he is calling about the Pfizer Vaccine; states he had the 1st dose of the Pfizer Vaccine and had a really severe reaction with it;States he realized that having had covid in late January could affect him a lot more with the vaccine. States he had covid in late January 2021 and that can react a lot with the Pfizer Vaccine and he understands that and does not know if this is actually an allergy of the vaccine in these few days of the last 7 days or if is the Tylenol reacting with the vaccine.States the Tylenol and Ibuprofen were the two ones that were recommended to take and he took them and the Tylenol and Ibuprofen gave him a severe headache and it was really really bad on the 5th day which was yesterday and the pressure from the headache he could feel and it was a slight pressure and was uncomfortable and the left side of his body and his eyes were numb and the left arm was numb; states after that the next day on the 5th day, he had a tight pressure in his head and in late afternoon the pain was starting to get tighter with a severe headache.States he took Tylenol yesterday and the whole week which is Tylenol Extra Strength 500mg and yesterday took two tablets and on the 2nd day Sunday 18Apr2021 he took about 5 tablets the whole day and the bottle has expiry date 2024 and lot ABC207. States he took Ibuprofen 200mg with expiry date Dec2022 and lot WJ02713. No follow-up attempts are needed; information about lot/batch number cannot be obtained. This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17Apr2021 10:35 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced chills (chills) (medically significant) on 18Apr2021 with outcome of unknown , flu symptoms (influenza) (medically significant) on 18Apr2021 with outcome of unknown , severe headaches (headache) (medically significant) on an unspecified date with outcome of unknown , strong pain in my head, my left arm and left eye (pain in extremity) (medically significant) on an unspecified date with outcome of unknown , strong pain in my head, my left arm and left eye (eye pain) (medically significant) on an unspecified date with outcome of unknown , light pressure during the morning in my head not as severe as the other days (head discomfort) (medically significant) on an unspecified date with outcome of unknown , whole body turned red (erythema) (medically significant) on an unspecified date with outcome of unknown , bumps (swelling) (medically significant) on an unspecified date with outcome of unknown , itchy (pruritus) (medically significant) on an unspecified date with outcome of unknown , nausea (nausea) (medically significant) on an unspecified date with outcome of unknown , stomach ache (abdominal pain upper) (medically significant) on an unspecified date with outcome of unknown , eyes were numb (hypoaesthesia eye) (medically significant) on an unspecified date with outcome of unknown , left arm was numb (hypoaesthesia) (medically significant) on an unspecified date with outcome of unknown , rash all over his body (rash) (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021 . The action taken in response to the event(s) for bnt162b2 was not applicable. This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17Apr2021 10:35 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced chills (chills) (medically significant) on 18Apr2021 with outcome of unknown , flu symptoms (influenza) (medically significant) on 18Apr2021 with outcome of unknown , severe headaches (headache) (medically significant) on an unspecified date with outcome of unknown , strong pain in my head, my left arm and left eye (pain in extremity) (medically significant) on an unspecified date with outcome of unknown , strong pain in my head, my left arm and left eye (eye pain) (medically significant) on an unspecified date with outcome of unknown , light pressure during the morning in my head not as severe as the other days (head discomfort) (medically significant) on an unspecified date with outcome of unknown , whole body turned red (erythema) (medically significant) on an unspecified date with outcome of unknown , bumps (swelling) (medically significant) on an unspecified date with outcome of unknown , itchy (pruritus) (medically significant) on an unspecified date with outcome of unknown , nausea (nausea) (medically significant) on an unspecified date with outcome of unknown , stomach ache (abdominal pain upper) (medically significant) on an unspecified date with outcome of unknown , eyes were numb (hypoaesthesia eye) (medically significant) on an unspecified date with outcome of unknown , left arm was numb (hypoaesthesia) (medically significant) on an unspecified date with outcome of unknown , rash all over his body (rash) (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021 . The action taken in response to the event(s) for bnt162b2 was not applicable.
33 2021-05-07 seizure I had a seizure and I am not common to having seizure; This is a spontaneous report from a contactab... Read more
I had a seizure and I am not common to having seizure; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 33-year-old, dose 2 via an unspecified route of administration, administered in left arm on 21Apr2021 (Lot Number: ER8735) as single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included bisoprolol 10 mg. The patient was previously vaccinated with the first dose of BNT162B2 on 31Mar2021 at the age of 33-year-old for COVID-19 immunisation. The patient stated that he had a seizure on 21Apr2021, and he was not common to having seizure. No treatment was received for the event. The outcome of the event was recovering.
33 2021-05-08 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Additional D... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Additional Details: Patient fainted immediately after dose, fell and hit his head, a scrape on his forehead was cleaned up with hydrogen peroxide, applied antibiotic ointment, and covered up. Patient was given water and orange juice, his BP and pulse were within normal limits. Advised him not to drive home and to make appointment with doctor to rule out concussion. A relative is picking him up.
33 2021-05-09 feeling cold Fever, chill ness and body aches
33 2021-05-09 tenderness Information obtained from mother. Pt. c/o a lump on left shoulder near the neck about 1 weeks after... Read more
Information obtained from mother. Pt. c/o a lump on left shoulder near the neck about 1 weeks after 1st covid vaccination. It is about 1/2" in size, oval in shape. It is tender but not painful. The lump has not changed in size. He has not sought care because of having no insurance. Mom was given names of local clinics for uninsured.
33 2021-05-13 seizure, unresponsive to stimuli Patient post-vaccination (Pfizer/0.3ml/1st dose administered @10:23a) appeared to be seizing in his ... Read more
Patient post-vaccination (Pfizer/0.3ml/1st dose administered @10:23a) appeared to be seizing in his chair during observation @ 10:26a. I rushed to him, requesting aid from his colleagues to help lay him on the ground and elevate his feet. He was unresponsive and disoriented, with shallow breathing and weak pulse, so I activated EMS @ 10:26a. He appeared to seize again so I instructed two men to help roll him onto his side, at which time, an RN managing the vaccines, took over monitoring while I talked to 911. EMS was on scene @ 10:29a. RN reports he'd had a vagal response, most likely due to witnessed severe anxiety during IM injection (name /right deltoid @ 10:23a). RN gave him Gatorade and he quickly became AOx3. When EMS arrived, he was able to stand up, with assist, and be placed on the gurney. EMS monitored him for ~ 20min onsite, at which time he became hypotensive, resulting in transport to the nearest ER with O2 and IV management. Per HR representative for a business patient was discharged @ ~2p the same day, with diagnosis of severe dehydration and hypokalemia, his reaction most likely a vagal event. Unknown if medications were given outpatient.
33 2021-05-16 cold sweat C/O feeling dizzy, pale, and cool clammy to touch. BP 110/78, P 60 and thready, resp 12 denies SOB ... Read more
C/O feeling dizzy, pale, and cool clammy to touch. BP 110/78, P 60 and thready, resp 12 denies SOB or swallowing problems. EM serv notified and arrived @ site to assess.
33 2021-05-16 numbness Headaches, numb swollen feeling in only left side of face, diarrhea
33 2021-05-16 seizure Pt had seizure like event May2, getting worked up
33 2021-05-17 concussion concussion; lost consciousness; fell; hit my head on the bathroom floor; This is a spontaneous repor... Read more
concussion; lost consciousness; fell; hit my head on the bathroom floor; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 33-years-old, via an unspecified route of administration, administered in Arm Left on 27Apr2021 12:45 PM (Lot Number: EW0171) as single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, syncope from an unknown date and unknown if ongoing (last episode 2008). Concomitant medication included minocycline hcl taken for an unspecified indication, start and stop date were not reported at 50mg. (patient received within 2 weeks of vaccination). Patient received first dose of bnt162b2 at the age of 33-years-old, administered in Arm Right on 06Apr2021 12:30 PM (Lot Number: EW0158) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In the middle of the night, patient woke up to use the bathroom. At some time, he lost consciousness, fell, and hit head on the bathroom floor. Patient regained consciousness around 3am. At the hospital, he was diagnosed with a concussion. Event start date was at 28Apr2021 01:00 AM. Events resulted in Emergency room/department or urgent care, Hospitalization. Days hospitalization was 1. Treatment received for the adverse event was Testing and observation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. Covid test name post vaccination was BioFire, Type post vaccination was Nasal Swab, test date on 28Apr2021, test result was Negative. Events outcome was recovering. Information on Lot/Batch number was available. Additional information has been requested.
33 2021-05-17 tingling At approximately 5:20pm on 5/10/21 I started having jumbled speech. I would be speaking clearly and ... Read more
At approximately 5:20pm on 5/10/21 I started having jumbled speech. I would be speaking clearly and then random words would take the place of the words I was trying to say. I was unable to use the correct words my brain was telling myself to say. Then I started experiencing tingling sensation throughout my right arm. Believing that I could be having a stroke my wife rushed me to the emergency room at hospital. En route to the ER, my left arm began to have tingling sensation in it as well. Once at the ER I began hyperventilating. I was in the ER for approximately 4-5 hours, for 3 of those hours I had difficulty communicating and could not speak clearly. I was told I may have been having a complex migraine and was discharged and referred to a neurologist. I met with the neurologist and given that I have no history of headaches or migraines, they concluded that it most likely was not a complex migraine and discussed the possibility of an immune response. It has now been a week since my ER visit, since then I have been getting extremely fatigued every afternoon and my head feels spacey.
33 2021-05-17 seizure Second day after shot, fever began and has not subsided. Three and a half days later, seizures began... Read more
Second day after shot, fever began and has not subsided. Three and a half days later, seizures began.
33 2021-05-19 weakness, sensory loss ascending weakness, areflexia, lack of sensation, progression to quadriplegia; GBS syndrome
33 2021-05-19 myelitis transverse, tingling, numbness spinal cord swelling/ transverse myelitis; multiple sclerosis; lesions in the brain; It was hard for... Read more
spinal cord swelling/ transverse myelitis; multiple sclerosis; lesions in the brain; It was hard for him to walk. He has to hold on to walls to walk.; Patient started to get terrible numbness in his feet. The numbness moved to up his left leg. Patient could not walk because of his left leg numbness.; patient cannot walk; Severe back pain; both feet have numbness and tingling; This is a spontaneous report from Pfizer. A contactable nurse (patient's mother) reported that a 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 13Apr2021 13:30 (Batch/Lot Number: EW0153) (at the age of 33 years old) as 1st dose, single for COVID-19 immunisation. Medical history included surgery on his leg (when he was 17) and cold. There were no concomitant medications. Patient had a severe reaction to the covid vaccine. On 17Apr2021 at 08:00, the patient had severe back pain. On Sunday morning (25Apr2021), patient had severe back pain. Patient was a former college athlete. Patient was mentally healthy and physically fit. Patient did not remember getting hurt while playing golf. Patient iced his back and did some stretches. Patient called his friend who is a doctor, and his friend told him he did the right thing by icing and stretching. A few days later, either Tuesday evening, 27Apr2021 or Wednesday, 28Apr2021, patient started to get terrible numbness in his feet. The numbness moved to up his left leg. Patient could not walk because of his left leg numbness. Patient was able to get down a flight of stairs and then called an uber. Patient was taken to the hospital. It was his left foot and left leg initially. Now both feet have numbness and tingling. It was hard for him to walk. He has to hold on to walls to walk (also reported as Patient could not walk because of his left leg numbness. Patient cannot walk. Patient can now only stand if he is holding a wall). He went to the emergency department on 29Apr2021 and got an MRI of back and lower legs, "all was negative for slip disc or spinal cord swelling. Patient had an MRI of his lower back, and legs. The MRI results were that patient had no spinal cord compression that would cause his left lower leg numbness. Patient was admitted to the hospital, to the neurology department, with a consult for a neurosurgeon to see him. The doctors agreed that he had something going on since he had left lower leg numbness. In the course of four days, Thursday through Sunday, patient was admitted to hospital in the neurology unit. Patient was in an overflow area. Several hospitals around that area have closed, so now the hospital is seeing so many more patients, and the hospital is over capacity. Patient was admitted by a hospitalist, and then was referred to a neurology team. The doctors said that that does not explain patient's symptoms, so the doctors ordered a head to toe MRI with contrast. He was admitted to the hospital and continued to have severe back pain then, the doctors did another head to toe MRI with contrast and then they said he has "MS due to brain lesions and spinal cord swelling the length of his spinal cord." They also did a spinal tap. The family kept telling the MDs that he had just received his Pfizer vaccine. The patient denies any weakness or numbness in past 6 months. He continues to have numbness in both feet and now the left leg is always numb. The doctors gave him an outpatient appt at the end of June. It felt like whenever he sits on his foot while watching TV, and it starts going numb. By the time that patient was getting testing done, the nurses covered patient's eyes, and told patient to tell them whenever he could feel it. The doctors and nurses were sticking pens in patient's feet, and patient could not feel it at all. Patient could only feel pressure. On Friday, 30Apr2021, patient had a head to toe MRI with contrast. Reporter thinks that patient got back to his room after the total body MRI about 22:15. The head to toe MRI with contrast revealed that patient had spinal cord swelling, and lesions in the brain. Doctors diagnosed patient with multiple sclerosis. Patient has never had any symptoms of multiple sclerosis. Reporter's husband feels like patient could have transverse myelitis, because some vaccines can cause that. Reporter's husband asked patient's doctor to contact Pfizer to see if there was anything in place about how to treat this. On Thursday, patient's doctor told reporter's husband that there had been no reported adverse effects of spinal cord swelling from the covid vaccine. On Sunday, whenever patient was discharged, patient's doctor told reporter's husband that he was not going to call and report about patient to Pfizer, and that there had already been 45 documented cases. This was a really big red flag to reporter. Patient cannot walk. Patient can now only stand if he is holding a wall. Before this, he was totally healthy. Patient was discharged from the hospital on Sunday. The hospital sent his MRI results, lab work, and spinal tap fluid after his MRI to Clinic. The doctors did the spinal tap on patient to make sure he did not have an infection. Patient did not have an infection. The doctor started patient on Lyrica and some other drug. The hospital told patient to call back in two weeks, because by then they would have stuff back from Clinic, and then he could make a follow up appointment. Upon discharge, patient was told that maybe he could get a follow up appointment in Jun2021. Everything that reporter has read, says that patient's condition needs to be followed up on as soon as possible. Patient cannot walk. This is going to financially cripple patient. Reporter is sure that after this, patient will meet his deductible and is going to have to pay out all of this money to cover his hospital stay and testing. Before the COVID vaccine, patient did not have any problems at all. Patient had to have surgery on his leg when he was 17. Patient has no history of back pain. By the time the doctors and nurses did testing, that was late Friday evening, 30Apr2021 or Saturday morning, 01May2021. By the time that the testing was done, both of patient's feet and left leg were totally numb. The hospital said that patient's symptoms were terrible, and that he had something acute going on. The hospital ran tests on patient. Patient told the doctors at the hospital that he had recently received the COVID vaccine. Patient was never sick he might get a cold every once in a while. Other than that, patient only sees the doctor once a year for a physical. The hospital did preliminary lab work on patient. Patient's vital signs were stable, and he had no fever. After patient received three doses of IV Solu-Medrol, his back pain went away. Patient's doctors felt like patient's spinal cord swelling had diminished. Patient's doctors felt like patient's spinal cord swelling is what cause patient's numbness and tingling. The first dose of IV Solu-Medrol was given sometime on 30Apr2021. Patient received IV Solu-Medrol 1 gram, three days in a row.The doctors said that was all they were going to do at this time. The doctors wanted to wait to see what the lumbar puncture shows (unknown results). Patient was given IV Solu-Medrol while in the hospital. Patient was put on Lyrica and gabapentin. The doctors are hoping that those two medications will make his symptoms go away. Patient used to take a multivitamin for years, but reporter does not know if patient still takes that. Patient is super healthy. Patient was admitted to the hospital on 29Apr2021, and discharged on 02May2021 after receiving his last dose of IV Solu-Medrol. The patient had no COVID prior vaccination. The patient had Nasal Swab (COVID test) on 28Apr2021 and was negative. Event relatedness to Pfizer COVID vaccine: Severe back pain and Patient started to get terrible numbness in his feet. The numbness moved to up his left leg. Patient could not walk because of his left leg numbness. Patient cannot walk. Patient can now only stand if he is holding a wall was related. Reporter stated that she thinks his symptoms are medically significant, but they could be disabling. If the COVID vaccine gave patient multiple sclerosis or transverse myelitis, this could be disabling. The outcome of the event back pain was recovered in May2021; event spinal cord swelling was recovering; events "terrible numbness in his feet. The numbness moved to up his left leg. Patient could not walk because of his left leg numbness and It was hard for him to walk. He has to hold on to walls to walk" were not recovered; and unknown outcome for the other events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the multiple sclerosis, transverse myelitis and other reported events 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 spinal MRI at baseline, 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 2021-05-19 pain in extremity Mild fever of 100.4; Headache; sore arm; fatigue; headache Aches; This is a spontaneous report from ... Read more
Mild fever of 100.4; Headache; sore arm; fatigue; headache Aches; This is a spontaneous report from a contactable nurse (Patient himself). This 33-year-old male nurse (Patient) received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via Intramuscular in left arm on 04Jan2021 at 10:00 and second dose via Intramuscular in left arm on 27Jan2021 at 12:30, both as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. The patient was diagnosed with COVID-19 prior to vaccination. The patient tested with COVID-19 post vaccination was unknown. On 27Jan2021 at 17:00, the patient experienced mild fever of 100.4, headache aches, sore arm, fatigue. No treatment was received for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested. Follow-up (19Apr2021): 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 2021-05-20 tenderness Swollen lymph nodes in armpit on right arm. The same arm where the shot was given. Lot of fluid in a... Read more
Swollen lymph nodes in armpit on right arm. The same arm where the shot was given. Lot of fluid in armpit. Tender as well. This was my second Pfizer Covid shot.
33 2021-05-21 bell's palsy, numbness Left side of my face started numbing, felt like if a nerve popped while eating a sub, next day in th... Read more
Left side of my face started numbing, felt like if a nerve popped while eating a sub, next day in the morning lost control on my left side lip, started dripping saliva while sleeping and water while brushing my teeth., couldn?t drink water, couldn?t blink my eye. Im still the same until now.
33 2021-05-22 seizure, feeling hot Systemic: Seizure-Mild, Additional Details: patient got vaccine and about 3 minutes after dose was e... Read more
Systemic: Seizure-Mild, Additional Details: patient got vaccine and about 3 minutes after dose was experiencing feeling hot and excessive sweating. Patient then passed out and had seizure with loss of consiusness, convulsion, and clenched jaw. Patient regained consciousness in about 10-15 seconds and was disorriented ambulance was called and patient was taken to hospital. Hx of seizure 1 time in past year not currently on antiepleptic medication
33 2021-05-23 tingling BP147/83, patient reported tingling to R arm. Patient was administered 25mg of Benadryl Po. Complain... Read more
BP147/83, patient reported tingling to R arm. Patient was administered 25mg of Benadryl Po. Complained of palpitations, probably related to anxiety. Ice pack was applied to back of the neck. Patient was discharged home.
33 2021-05-24 migraine with aura Had migraine with aura for first time in my life on 4/23, then a second on 4/29, which is one day af... Read more
Had migraine with aura for first time in my life on 4/23, then a second on 4/29, which is one day after my second dose. Then had a third one on 5/20. Saw doctor on 5/25 to confirm it was migraines since I had never had them before.
33 2021-05-25 weakness The following morning, I had body aches, headaches and I took some Tylenol. They only lasted through... Read more
The following morning, I had body aches, headaches and I took some Tylenol. They only lasted through the late afternoon and early evening. And then following that, in the weeks following, I started noticing I would get headaches two or three times a week and often it would be something that I would get a headache at night and it would worsen in the morning and it would last for 24 hours before it would go away. Sometimes I took Tylenol and sometimes I would just try massaging it .On, February 17, I saw my doctor and he told me to try Aleve instead and to up the dose of it. When I do that it curbs the headaches a bit for sure. Since seeing him, this week I had two and the two weeks prior I didn't have any. They start in the back of the neck and go to my upper back and when it is at its worse: goes to the tops and sides of my head. Pretty debilitating - I couldn't do a whole lot when I have these. I had one yesterday into this morning. I don't know if it has to do with the vaccine. I got my first dose of the vaccine on December 23 and they had told to wait for the second dose because I got COVID after the first day.
33 2021-05-25 pain in extremity Chest pain, SOB, left arm pain, nausea, body aches , sweating, inability to lie down. Started 4/26 1... Read more
Chest pain, SOB, left arm pain, nausea, body aches , sweating, inability to lie down. Started 4/26 10 pm. To Medical Center ER at approx 5:30 am. 4/27/21. Admitted to cardiac unit. Myocarditis
33 2021-05-25 tingling, numbness, pain in extremity, weakness, muscle spasms About a week or so after my first dose I started having muscle tightness and cramping in my legs and... Read more
About a week or so after my first dose I started having muscle tightness and cramping in my legs and some ?electric? type radiating shots down my left leg starting up in my thigh down to my ankle. I thought it was getting better but then a week or so after my second shot I began having worse leg problems (weakness, pains, pulsing, numbness, tingling). It?s just gotten worse and I?m having tests done and seeing a neurologist.
33 2021-05-25 seizure Seizure with loss of consciousness, but without passing out, lasting shorter than 2 minutes with no... Read more
Seizure with loss of consciousness, but without passing out, lasting shorter than 2 minutes with no prior history of seizures. Other present symptoms included: aura including heightened fear, visual and auditory abnormalities, loss of awareness, loss of muscle control in face and neck, staring episode, breathing difficulties/gurgling, and loss of bladder control. All symptoms subsided upon regaining consciousness/awareness.
33 2021-05-26 inability to speak First dose caused no noticeable symptoms. Second dose caused fatigue and intense brain fog. I (patie... Read more
First dose caused no noticeable symptoms. Second dose caused fatigue and intense brain fog. I (patient) expected symptoms to subside, but they did not. Now over a month later (May 27, 2021), still experiencing brain fog symptoms as follow: cognitive impairment, short and long term memory loss, difficulty finding/saying certain words. Symptoms are akin to a geriatric dementia patient, but in an otherwise healthy 33 y/o male with no underlying conditions. Onset of symptoms was acute following vaccination.
33 2021-05-26 cold sweat, tingling Patient c/o dizziness and nausea 3:25 PM Vitals: BP 102/56 HR 71 Resp 16 O2Sat 90 Skin Signs: Coo... Read more
Patient c/o dizziness and nausea 3:25 PM Vitals: BP 102/56 HR 71 Resp 16 O2Sat 90 Skin Signs: Cool, clammy, diaphoretic, other - pale Initial Treatment: 3:24 PM patient states he feels tingling sensation in his hand bilaterally. Patient presents very pale, diaphoretic, and cool. Denies previous medical hx. 3:27 PM patient continues to improve, denies emesis but continues to present pale and diaphoretic. 3:40 PM Vitals: BP 102/62 HR 68 O2Sat 96 Skin Signs: Diaphoretic, other - pale Follow up Treatment: Continue to monitor patient. Advised patient to drink water and provided patient with juice. 3:55 PM Vitals: BP 116/60 HR 52 O2Sat 97 Skin Signs: Warm and dry Follow up Treatment: Patient continues to improve both in presentation and vitals. He stated he feels better and is ready to go home. Home with SO driver.
33 2021-06-01 weakness, pain in extremity Inflammation of entire body/ specifically lower body; Headaches; double vision; Low energy; Low sens... Read more
Inflammation of entire body/ specifically lower body; Headaches; double vision; Low energy; Low sensation; Neck pain; Extreme foot pain; Nervousness; anger; This is a spontaneous report from a contactable consumer (patient, self-reported). A 33-year-pld male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number and Expiry date: unknown), dose 2 via an unspecified route of administration in the right arm, on 06May2021 at 17:00, as single for COVID-19 immunization in the pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient had no allergies. The patient previously patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number and Expiry date: unknown), dose 1 via an unspecified route of administration in the right arm, on 24Apr2021 at 11:00, as single 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. The patient did not receive any other medications within 2 weeks prior. On 17May2021 at 01:00, the patient had inflammation of entire body/ specifically lower body, headaches, double vision, low energy, low sensation, neck pain, extreme foot pain, nervousness, and anger. The outcome of the events were not recovered. Information on the lot/batch number has been requested.
33 2021-06-02 discomfort mild myocarditis (tight hear muscle) in day time tightness gets stronger usually at night, causes di... Read more
mild myocarditis (tight hear muscle) in day time tightness gets stronger usually at night, causes discomfort in sleeping
33 2021-06-02 numbness, tingling headache, dizziness, brain fog/disorientation, tingling/numbness in extremities.
33 2021-06-03 pain in extremity ONE WEEK LATER, PT STARTING FEELING PAIN LEFT CALF.
33 2021-06-03 tingling, numbness numbness and tingling on my left cheek; numbness and tingling on my left cheek; This is a spontaneou... Read more
numbness and tingling on my left cheek; numbness and tingling on my left cheek; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 29May2021 at 10:15 (at the age of 33 years) as 1st single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced minor numbness and tingling on his left cheek on 29May2021. The patient received first dose of the Pfizer COVID vaccine and had a minor reaction of numbness and tingling on his left cheek, few (2-3) hours after the vaccine. It was reported that patient did not think that this should be a concern or if it was something that would happen after vaccine and enquired about the side effect, whether it was common and will it go. The outcome of the event was unknown. Follow up attempts are completed. No further information is expected.
33 2021-06-06 muscle twitching Patient started to have muscle twitching of deltoid vaccine administered (left deltoid) occurred app... Read more
Patient started to have muscle twitching of deltoid vaccine administered (left deltoid) occurred approximately 1 week following vaccination and lasted for a duration of 1 week. Mild sore arm day following vaccination with no other symptoms.
33 2021-06-07 weakness For 40 hours (2 nights and 1 day) Fever, Chills, Head Aches, Soreness all over body, fatigue, inabil... Read more
For 40 hours (2 nights and 1 day) Fever, Chills, Head Aches, Soreness all over body, fatigue, inability to sleep, no mental capacity for even basic activity such as reading or watching TV. I would rate this as on par with worst sicknesses I have ever had in my life. For next approx. 30 hours - soreness all over body, head aches, not as bad as previous day. Next 24 hours - Soreness on right side, akin to being hit by a baseball fastball in 4 spots on my right side (arm, leg, 2 spots on body) about every 5 minutes. Next 24 hours leg every muscle from knee to hip was sore and hardly moveable like I had participated in an all day sporting event the day before. For the next week or so I had aftershock headaches, occassional mild headaches that would last for less then a minute. Gradually went down in duration and frequency over time. Also that next week, felt very fatigued and low energy.
33 2021-06-07 burning sensation Second covid-19 vaccine (Pfizer) on 6/1/21 Says about 5 minutes later he got a temporary electrical ... Read more
Second covid-19 vaccine (Pfizer) on 6/1/21 Says about 5 minutes later he got a temporary electrical pain that radiated from the right scapula up into the right scalp Also developed injection site pain, fever, chills, severe arthralgias within the first 24-48 hours Then on 6/4, developed right neck and scalp rash Burning, electrical pain and also some swelling Also on the right anterior neck area Some ear pain No facial involvement Diagnosed with Shingles June 7, 2021.
33 2021-06-07 discomfort I started to feel pressure build up on the inside of my body & almost started to blackout. It seeme... Read more
I started to feel pressure build up on the inside of my body & almost started to blackout. It seemed like Heat Inflammation.
33 2021-06-07 sensory loss, numbness Nausea; Body ache; Loss of feeling in the left arm; I have numbness and loss of feeling in left arm;... Read more
Nausea; Body ache; Loss of feeling in the left arm; I have numbness and loss of feeling in left arm; Tightening in my fingers.; This is a spontaneous report received from a contactable male consumer (patient). A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0176, Expiration date: unknown), via unspecified route, on 27may2021 over left arm (at the age of 33-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Her second is scheduled on 17jun2021. No other vaccines were taken prior 4 weeks. Family medical history was reported as blood pressure. On 30may2021 at 10:00, 3 days 10 hours after the vaccination, the patient experienced Nausea, Body ache, Loss of feeling in the left arm, numbness in left arm, Tightening in my fingers. The reporter assessed all events as non-serious. She wanted to know if the presented reactions are normal or not. She also asked about the need of meeting a doctor. The outcome of all the events was unknown. No follow-up attempts possible. No further information expected.
33 2021-06-09 cold sweat, cold extremities After my vaccination I experienced clamminess and fatigue. I was given a drink of juice by the nurs... Read more
After my vaccination I experienced clamminess and fatigue. I was given a drink of juice by the nurses and I felt ok afterward. Now I'm experiencing heart palpitations and cold hands and feet.
33 2021-06-09 pain in extremity REPORTED: ARM SORENESS, BRUISING, LETHARGY FOR 1 WEEK, RADIAL TENDONITIS INJURY REAGGRAVATED, EFFEC... Read more
REPORTED: ARM SORENESS, BRUISING, LETHARGY FOR 1 WEEK, RADIAL TENDONITIS INJURY REAGGRAVATED, EFFECTS BEGAN WITHIN A FEW HOURS AND LASTED 1 WEEK
33 2021-06-09 tremor Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, ... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Additional Details: Patient came in for 2nd dose of pfizer vaccine on 6/9/21. He complained he was feeling dizzy after the shot,checked his blood pressure and ot was 90/45. Gave him a bottle of water, rechecked his blood pressure and it was 80/40. He asked if we can call 911, paramedic showed up in less than 5 min, no epinephrine was given to the patient. Paramedic said everything looks fine, he had a syncopy after the shot. His final blood pressure was 130/90. He was escortrd out,willl follow up with him on 6/9/21.
33 2021-06-10 pain in extremity sore arm; little tired; This is a spontaneous report from a contactable consumer or other non hcp. ... Read more
sore arm; little tired; This is a spontaneous report from a contactable consumer or other non hcp. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), dose 1 via an unknown route of administration on 20May2021 as single dose for covid-19 immunisation. Medical history included stroke from 2019 that was caused because the heart valve, PFO, never closed when he was born so he had an occluder put in. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) taken once a day for an unspecified indication and ongoing. On 20May2021, the patient experienced sore arm and a little fatigue. He has scheduled to get the second dose on 10Jun2021. Outcome of events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
33 2021-06-12 pain in extremity, discomfort 6/4 (around midnight) - fevers (high around 104/105) and chills 6/6 - symptoms subsided in the morni... Read more
6/4 (around midnight) - fevers (high around 104/105) and chills 6/6 - symptoms subsided in the morning upon rising 6/8 - woke up with squeezing and stabbing pain radiating from left elbow to left wrist 6/8 - went to ER; ECG was administered and came back clean; blood was taken and showed troponin levels to be moderately high; heparin then administered and heart monitor put on; continued to collect blood 6/8 -6/10 - admitted to a different hospital facility for observation; blood collected and heparin continued to be administered; echocardiogram and heart cath procedure performed; no damage or blockages found in heart
33 2021-06-12 pain in extremity After receiving second dose, patient was experiencing sore and achy arms. However, now he's reportin... Read more
After receiving second dose, patient was experiencing sore and achy arms. However, now he's reporting that the pain has gone down to his elbow. He says, it doesn't hurt when he's moving his arm up and down, but is sore when he's pulling on something, such as a door knob
33 2021-06-13 discomfort Development of cyst-like, ball-shaped protrusion under dermis adjacent to/resting against right, cen... Read more
Development of cyst-like, ball-shaped protrusion under dermis adjacent to/resting against right, center section of clavicle. Size/circumference of protrusion comparative to dime (coin). Minor tissue irritation and discomfort at location/site of protrusion. Possibly correlated, development of muscle ache in rear and sides of neck, extending to upper shoulder/trapezius.
33 2021-06-14 muscle twitching Muscle twitching at site of injection at both vaccination sites (Dose 1, Pfizer-BioNTech Covid-19 Va... Read more
Muscle twitching at site of injection at both vaccination sites (Dose 1, Pfizer-BioNTech Covid-19 Vaccine Lot# EP7533, left arm, intramuscular). Fasiculations of up to 3 per minute directly located where vaccine was injected. Occurs daily in intervals of 30minutes, up to 4 times per day. It occurs in both arms since it was first noticed on May 24th (38 days after 2nd dose of vaccine). It prevents sleep and causes distress.
33 2021-06-15 numbness Right and left ulnar nerve damage caused upon injection. Found by emg by dr Muscle weakness in leg... Read more
Right and left ulnar nerve damage caused upon injection. Found by emg by dr Muscle weakness in legs hands and feet. Numbness of legs hands and feet.
33 2021-06-16 hot flush There where times where I felt I was going to pass out; I became very dizzy and fatigued/ light head... Read more
There where times where I felt I was going to pass out; I became very dizzy and fatigued/ light headedness; I became very dizzy and fatigued; Had extreme brain fog and light headedness; Had shortness of breath. Tightness in throat and dry mouth; Tightness in throat and dry mouth; Tightness in throat and dry mouth; I also developed a very strong metal taste in my mouth that lasted for a few weeks; Sometimes I would also get strange sensations or weakness in my muscles with sweats or hot flashes; Sometimes I would also get strange sensations or weakness in my muscles with sweats or hot flashes; Sometimes I would also get strange sensations or weakness in my muscles with sweats or hot flashes; Some days I would wake up feeling like I was intoxicated like a drunk feeling; The feelings also came with extreme anexity and panic although the symptoms themselves could have caused that; The feelings also came with extreme anexity and panic although the symptoms themselves could have caused that; Sometimes I would also get strange sensations or weakness in my muscles with sweats or hot flashes; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11May2021 10:15 (at 33-year-old) (Lot Number: EW0182) as 2nd dose, single in arm right for COVID-19 immunisation. Medical history included anxiety, depression, and panic. No known allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Apr2021 15:30 (at 33-year-old) (Lot Number: EW0171) as 1st dose, single in arm right for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. After about 7-10 days after 2nd dose vaccination he became very dizzy and fatigued, and had extreme brain fog and light headedness. There where times where he felt he was going to pass out. He also had shortness of breath, tightness in throat and dry mouth. He also developed a very strong metal taste in his mouth that lasted for a few weeks. Sometimes he would also get strange sensations or weakness in his muscles with sweats or hot flashes. Some days he would wake up feeling like he was intoxicated like a drunk feeling. The feelings also came with extreme anexity and panic although the symptoms themselves could have caused that. The onset date of events was reported as 14May2021 02:30 am. No treatment received for events. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events was resolving.
33 2021-06-17 muscle twitching, speech disorder I woke up the next day with a severe twitch in my right eye and had trouble speaking and getting wor... Read more
I woke up the next day with a severe twitch in my right eye and had trouble speaking and getting words out. The eye twitch lasted for 3 months and I am currently still have slight speech impairment. I am basically waiting it out and seeing if it will improve.
33 2021-06-21 bell's palsy Bells Palsy
33 2021-06-22 muscle spasms Extreme muscle pain, muscle spasms, skin pain, eye pain, pupil dilation, headache, nausea, vomiting,... Read more
Extreme muscle pain, muscle spasms, skin pain, eye pain, pupil dilation, headache, nausea, vomiting, extreme dizziness, fatigue, nose bleed, cough
33 2021-06-23 night sweats, pain in extremity My reactions to the second shot started with a sore arm, night sweating for the first day of injecti... Read more
My reactions to the second shot started with a sore arm, night sweating for the first day of injection (5/9). In the morning of the two days after the shot, there are also some minor nose bleedings. The primary reason I'm reporting is because of the symptoms below: On 5/10, I suffered from fatigue that I had to sleep every other couple of hours. In the night the adverse event that resembled myocarditis occurred when I went to bed (around 10 PM). The symptoms included respiratory difficulties/shortness of breath and severe chest pain especially when lying on my back, and pains in the upper body mostly in both arms. As a result, I wasn't able to sleep until 4 AM when these symptoms started to reduce. However the fatigue and periodic shortness of breath persisted for a couple of more days. I recognized these symptoms are much like the ones I experienced once in 2018, although I was able to get a diagnosis of myocarditis after being tested with ECG and blood tests. During that event the trajectory of serverless and recovery was similar.
33 2021-06-24 weakness fever; felt weak when standing or walking; chills; shortness of breath; This is a spontaneous report... Read more
fever; felt weak when standing or walking; chills; shortness of breath; This is a spontaneous report from a contactable Consumer (Patient). A 33-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 01Feb2021 at 14:45 (33 year age at the time of vaccination) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration in Left arm on 13Jan2021 at 14:45 (33 year age at the time of vaccination) for COVID-19 immunisation. Patient had no known allergies. Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 02Feb2021 at 08:30 AM, the patient experienced fever, felt weak when standing or walking, chills, shortness of breath. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for events. The outcome of event was recovered on an unspecified date in Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
33 2021-06-24 numbness Numbness on his lips and on the left side of his face; Numbness on his lips and on the left side of ... Read more
Numbness on his lips and on the left side of his face; Numbness on his lips and on the left side of his face; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 04Feb2021 (33-years-old at the time of vaccination), as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 04Feb2021 an hour after getting the vaccine, the patient experienced numbness on his lips and on the left side of his face. Patient wanted to know if this is a normal side effect of the vaccine. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
33 2021-06-24 unresponsive to stimuli, tremor, weakness Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shak... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Patient fainted for a few seconds within a couple minutes of vaccine. He the was shaking uncontrollably for a few seconds. We laid him down as per his request. We called 911. BP was 119/94. Fire dpt arrived and BP was 81/31 then 84/42. EMS arrived and took him into ambulance. Within 15-20 minutes, BP returned to normal and EMS sent patient home. We informed the MD and patient not to get her second one.
33 2021-06-27 tingling, numbness Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient's wife ca... Read more
Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient's wife called the pharmacy on 06/27/21 to say that the patient has been complaining of tingling in both arms that started 4 days after the second dose of pfizer covid 19 vaccine. She also said will contact his phisician tomorrow, we gave her the vaers toll-free n umber and also the phone number for pfizer safety reporting.
33 2021-06-28 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
33 2021-06-30 numbness Patient experienced numbness to the left side of their face a few hours after their vaccine, and las... Read more
Patient experienced numbness to the left side of their face a few hours after their vaccine, and lasted less than 36 hours. Labs were drawn at the ER. Bells Palsy was ruled out.
33 2021-06-30 pain in extremity, nerve pain, burning sensation nerve pain in face arms, legs, fingers, and toes; rapid high blood pressure; superficial thrombosis;... Read more
nerve pain in face arms, legs, fingers, and toes; rapid high blood pressure; superficial thrombosis; weakness in limbs/legs give out on me; constant nausea; pain behind eyes; right eye randomly goes blurry; pain and pressure in back of neck and legs; pain and pressure in back of neck and legs; pain and pressure in back of neck and legs; lightheaded/severe light headedness; almost blackout; rapid heart rate; hard to breath; throat swelling; severe pain and burning down full left side of body; severe pain and burning down full left side of body; severe headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received bnt162b2 (brand: PFIZER), dose 1 via an unspecified route of administration, administered in arm left on 03May2021 08:15 (Batch/Lot number was not reported, Unable to locate or read the details) as dose 1, single at the age of 33-year-old for covid-19 immunisation. Medical history included known allergies: Penicillin. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Other. Reported event: within 30 minutes was lightheaded/almost blackout, rapid heart rate, hard to breath, throat swelling, severe pain and burning down full left side of body, severe headache on 03May2021 08:45. 7 weeks later (Jun2021) still having headaches, nerve pain in face arms, legs, fingers, and toes, rapid high blood pressure, superficial thrombosis, weakness in limbs, legs give out on me, severe light headedness, constant nausea, pain behind eyes, right eye randomly goes blurry, pain and pressure in back of neck and legs. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalization for 1 day. Events seriousness reported as hospitalization and life threatening. Prior to 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 (Rapid): negative on 05May2021. The treatment received for the adverse event included pain medication. The event outcome was not recovered. Information on the lot/batch number has been requested.
33 2021-07-04 brain damage Other diseases of bronchus, not elsewhereclassified Onset: 20-Apr-20213:06 Comments: Onset Date: 202... Read more
Other diseases of bronchus, not elsewhereclassified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Acute respiratory failure with hypoxia Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Hypertensive heart disease with heart failure Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Heart failure, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 ABG (arterial blood gas) abnormal Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Acute kidney failure, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Polycythemia Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Hyperglycemia, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 ARDS (adult respiratory distress syndrome) Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Shock Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Acute respiratory failure Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Aspiration pneumonitis Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Abnormal CXR Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Cardiogenic shock Onset: 17-Apr-202114:26 Comments: Onset Date: 20210417 Cardiac arrest Onset: 17-Apr-202114:26 Comments: Onset Date: 20210417 Pulmonary infiltrate Onset: 17-Apr-202112:23 Comments: Onset Date: 20210417 Acute respiratory failure with hypoxia Onset: 17-Apr-202112:23 Comments: Onset Date: 20210417 Aspiration into airway Onset: 17-Apr-202112:23 Abnormal EEG Onset: 25-May-202112:11 Comments: Onset Date: 20210419 Encephalopathy Onset: 25-May-202112:11 Comments: Onset Date: 20210419 Acute thrombosis of right cephalic vein Onset: 19-May-202111:49 Comments: Onset Date: 20210425 Cardiomegaly Onset: 30-Apr-20216:24 Comments: Onset Date: 20210426 Ventricular fibrillation Onset: 29-Apr-20212:21 Comments: Onset Date: 20210427 Coma Onset: 27-Apr-202114:09 Comments: Onset Date: 20210422 Postoperative hemorrhage involving circulatorysystem following circulatory system procedure Onset: 26-Apr-202112:27 Comments: Onset Date: 20210421 Personal history of ECMO Onset: 26-Apr-202112:23 Comments: Onset Date: 20210419 Presence of ventricular assist device Onset: 26-Apr-202112:23 Comments: Onset Date: 20210419 Frequent PVCs Onset: 24-Apr-202112:49 Comments: Onset Date: 20210424 Presence of other vascular implants and grafts Onset: 24-Apr-20215:43 Comments: Onset Date: 20210418 Obesity, unspecified Onset: 24-Apr-20214:58 Comments: Onset Date: 20210417 Body mass index [BMI] 45.0-49.9, adult Onset: 24-Apr-20214:58 Comments: Onset Date: 20210417 Hyperthermia Onset: 23-Apr-202121:40 Comments: Onset Date: 20210419 Ventricular tachyarrhythmia Onset: 23-Apr-202112:14 Comments: Onset Date: 20210423 This code is used to indicate to the billing staff thatservices have been rendered and the chargeneeds to be coded. Onset: 22-Apr-202113:08 Comments: Onset Date: 20210421 Cardiomyopathy Onset: 22-Apr-202111:48 Comments: Onset Date: 20210422
33 2021-07-05 pain in extremity, coordination abnormal he couldn't stand up anymore; wasn't able to stand up with the muscle pain; couldn't support his leg... Read more
he couldn't stand up anymore; wasn't able to stand up with the muscle pain; couldn't support his legs any longer; fever; muscle pain; a stronger pain in his head; pain in his throat; heart beat was accelerated too much; flu like symptoms; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 33-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 07Jun2021 15:15 (at age of 33 years old) 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot no: EW0177) on 17May2021 (at age of 33 years old) at left arm as single dose for COVID-19 Immunization and experienced a lot of congestion, body aches, cough. Caller stated he had side effects to the Pfizer COVID 19 vaccine and went to the ER (emergency room). The patient said he had to go to the emergency room because of side effects he was having to the COVID 19 vaccine. He is asking who will pay for his medical expenses. He experienced fever, muscle pain, a stronger pain in his head, pain in his throat and also his heartbeat was accelerated too much, all on 13Jun2021. Second dose received on 07Jun2021 in the left arm. After the second dose, it was 4 days starting on the 13Jun2021 with flu like symptoms. On the 16Jun2021, he couldn't stand up anymore so he went to the emergency room. He couldn't stand up anymore so he had to go to the emergency room on 16Jun2021. He was discharged from the emergency room. The emergency room ran some tests and told him to take some Tylenol. He had a COVID 19 test and he is expecting a call with the results and the staff at the hospital took his temperature. He explained to the hospital staff that he was having the symptoms that are on the COVID 19 vaccine paperwork and that was the reason for his visit, since he had the two COVID 19 vaccines. He would like to point out that he asked the nurse when he was going to have the second dose, since the first vaccine he was still having side effects, he asked her if he was in danger to have the second vaccine. The nurse told him he was ok to get the second vaccine. The nurse told him he might have some muscle pain but he shouldn't be worried about it. At the emergency room he also had some blood tests. And also they took his pulse and after that the doctor was reading something in English that the interpreter couldn't catch and read. He provided Pfizer with what happened so far since he had the vaccine. He wasn't able to stand up with the muscle pain and he couldn't support his legs any longer, all on 16Jun2021. He would like to know if he's going to get some help with the medical bills. The patient underwent lab tests and procedures which included Blood test: negative, COVID-19 virus test: negative on 16Jun2021. The outcome of the events was unknown. information on the lot/batch number has been requested.
33 2021-07-13 numbness, muscle twitching, pain in extremity Arm pain and fatigue. Waking up with shooting pain in arm. Numbness and fatigue in legs. Persiste... Read more
Arm pain and fatigue. Waking up with shooting pain in arm. Numbness and fatigue in legs. Persistent fatigue and muscle twitching still two months after injection. In forearms, thighs, calves, buttocks, eye area. Neck stiffness. inflamed lymph nodes. longer recovery times from exercise. mild to moderate chest pain. severe shoulder pain return in left arm after exercise. Occasional
33 2021-07-17 numbness, facial paralysis, tingling, paralysis Numbness tingling and moderate paralysis and loss of motor function in left pinky, left thumb, left ... Read more
Numbness tingling and moderate paralysis and loss of motor function in left pinky, left thumb, left index, left forearm, left shoulder, left neck, left jawline, bottom lip of mouth, right shoulder
33 2021-07-17 pain in extremity chest pain/experienced chest pain, but it was more like a radiating pain that also effected their ne... Read more
chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; patient had some of the symptoms of the myocarditis or pericarditis; patient had some of the symptoms of the myocarditis or pericarditis; This is a spontaneous report from a contactable pharmacist. A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Batch/Lot number was not reported) via an unspecified route of administration and administered in left arm on 07Jun2021 (at age of 33 -years-old) as first dose 0.3 ml, single dose for COVID-19 immunization get protection from covid 19. The patient medical history and concomitant medications were not reported. Caller was a pharmacist calling on behalf of her patient who received the first dose of the Pfizer-BioNTech COVID19 vaccine on 7 Jun 2021 and experienced chest pain, but it was more like a radiating pain that also effected their neck and arm on the same day of vaccination. The patient came in to get their second dose. patient had some of the symptoms of the myocarditis or pericarditis. He was supposed to get the vaccine on Monday (28 Jun 2021) but caller said she wanted to talk to Pfizer to see if we had any recommendations on getting the second dose with a potential of having myocarditis or pericarditis. The chest pain lasted 3-4 days and was improved. Investigations as the caller does not think the patient had any tests done as he didn't seek any medical attention about this. Outcome of the chest pain was recovered on unspecified date in 2021 and other events was unknown. Reporter seriousness for chest pain but it was more like a radiating pain that also effected their neck and arm as Not serious and assessed as Related. Information on the lot/batch, further information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Myocarditis and Pericarditis and the 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 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 2021-07-17 tingling, numbness Facial tingling; facial numbness on left side of face; numb lips; dry mouth; This is a spontaneous r... Read more
Facial tingling; facial numbness on left side of face; numb lips; dry mouth; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: En6204), dose 1 via an unspecified route of administration, administered in Arm Left on 07Mar2021 at 12:00 (at the age of 33-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Patient's medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient previously took cipro (ciprofloxacin) and experienced drug hypersensitivity. There were no concomitant medications in two weeks.The patient did not received vaccine within 4 weeks prior to the suspect dose of vaccine. He did not have covid prior vaccination. On 08Mar2021 at 17:00, the patient experienced facial tingling, facial numbness on left side of face, numb lips and dry mouth. Patient did not receive any treatment for the events. He had not been tested for covid post vaccination. Outcome of the events were not recovered. No follow-up attempts are possible. No further information is expected.
33 2021-07-19 muscle spasms This is a spontaneous report from a contactable consumer, the patient. A 33-years-old male patient r... Read more
This is a spontaneous report from a contactable consumer, the patient. A 33-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via an unspecified route of administration in the left arm on 31Mar2021 at 12:15 (at the age of 33-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 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 was not tested for COVID-19. On 31Mar2021 at 23:00, the patient experienced full body muscle spasms. It was reported that the episode lasted for thirty minutes, stopped briefly then started again for a couple hours and it felt like a shiver from the cold but then it never stops and 100x worse. It was reported that he was exhausted after the spasm event. The patient did not receive any treatment for the 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 full body muscle spasms and exhausted was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
33 2021-07-20 tingling Persistent tingling in the feet; This is a spontaneous report from a contactable consumer, the patie... Read more
Persistent tingling in the feet; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 30Mar2021 at 15:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included sports induced asthma, prostatitis and rhinitis. The patient had no known allergies. Concomitant medications included fexofenadine (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL INHALER) from unknown dates and 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 30Mar2021 at 20:00, the patient experienced persistent tingling in the feet front half of the foot, 55 hours post first vaccination and still continued at the time of the report. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received any treatment for the event. The clinical outcome of the event persistent tingling in the feet was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
33 2021-07-22 feeling hot, hot flush Tuesday (7/20, AM, after waking up) - Tight chest, slight shortness of breath while standing, lastin... Read more
Tuesday (7/20, AM, after waking up) - Tight chest, slight shortness of breath while standing, lasting for about an hour. In the afternoon/early evening, short episode of feeling overheated and had to sit down during work. Wednesday (7/21, AM, after waking up) - Same as the day before, Tight chest, slight shortness of breath while standing, lasting for about an hour. In the afternoon/early evening, short episode of feeling overheated and had to sit down during work. Thursday (7/22, AM, after waking up) - Chest pain on the left side, specifically heart throbbing accompanied by hot flashes, persisted for about 45 min while standing.
33 2021-07-27 numbness Throat swelling; Tongue tingling; Numbness in back, mouth, hands, lips.; This is a spontaneous repor... Read more
Throat swelling; Tongue tingling; Numbness in back, mouth, hands, lips.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic moderate asthma, allergies, shellfish allergy, peanut allergy and allergy to nuts. Concomitant medications included mometasone furoate (FLONASE), vitamin D nos (MANUFACTURER UNKNOWN), BREO 100 and fish oil supplements; all from an unknown date 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 05Apr2021 at 11:00, the patient experienced throat swelling, tongue tingling, numbness in back, mouth, hands and lips. No therapeutic measures were taken as a result of 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 throat swelling, tongue tingling, numbness in back, mouth, hands and lips were resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.
33 2021-07-27 pain in extremity Watery diarrhea; Fatigue; Malaise; Nausea; Vomiting; Arm soreness; Headache; This is a spontaneous r... Read more
Watery diarrhea; Fatigue; Malaise; Nausea; Vomiting; Arm soreness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male 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 03Apr2021 at 08:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on 21Dec2020, hypertension (HTN) and hyperlipidemia. The patient did not have allergies to medications, food, or other products. Concomitant medications were not reported. 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 08:00, the patient experienced watery diarrhea, fatigue, malaise, nausea, vomiting, arm soreness and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient did not receive any treatment for the events. The clinical outcome of the events watery diarrhea, fatigue, malaise, nausea, vomiting, arm soreness and headache was recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
33 2021-07-28 pain in extremity, facial pain Hives all over body, itchiness, swollen lips, face hands and feet. Pain and wormth in the swollen ar... Read more
Hives all over body, itchiness, swollen lips, face hands and feet. Pain and wormth in the swollen areas.
33 2021-07-28 pain in extremity My arm has been sore for about 2 months now. Not a severe pain like 1-2 days after the vaccine but a... Read more
My arm has been sore for about 2 months now. Not a severe pain like 1-2 days after the vaccine but a constant soreness.
33 2021-07-28 pain in extremity Severe left arm pain; This is a spontaneous report from a contactable consumer, the patient. A 33-ye... Read more
Severe left arm pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male 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 06Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications within two weeks. 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 an unknown date in Apr2021 at 09:15, the patient experienced severe left arm pain, which was unbearable. 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 event. The clinical outcome of the event severe left arm pain was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
34 2021-01-05 flushing, tingling Reported feeling flushed, increased heart rate tingling fingertips difficulty focusing eyes.
34 2021-01-05 pain in extremity, feeling hot Burning anterior thigh pain on left 13hrs after injection; Burning hand pain on right; right hand wa... Read more
Burning anterior thigh pain on left 13hrs after injection; Burning hand pain on right; right hand was warm to touch relative to left; This is a spontaneous report from a contactable healthcare professional reporting for himself. A 34-year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 28Dec2020 at 08:00 PM (at the age of 34 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included hypertension (HTN), polymyositis, and psoriasis. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included olmesartan medoxomil (BENICAR), methotrexate, prednisone, vitamin C, and vitamin D. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 at 08:40 PM, 40 minutes after injection, the patient experienced burning hand pain on right, and the right hand was warm to touch relative to left. On 29Dec2020 at 09:00 AM, 13hrs after injection, the patient experienced burning anterior thigh pain on left. Treatment for the events included physical therapy nerve glides: for burning hand pain on right, and the right hand was warm to touch relative to left included Median Nerve Glides, with a frequency of once a day which improved 99% in 24hrs; and treatment for the event burning anterior thigh pain on left included Femoral Nerve Glides, with a frequency of 2-5 times a day which improved 85% in 3 days. The patient was recovering from the events burning hand pain on right, the right hand was warm to touch relative to left, and burning anterior thigh pain on left. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
34 2021-01-06 flushing, hot flush Patient describes chest pain, shallow breathing, sharp chest pain, patient has previous cardiac prob... Read more
Patient describes chest pain, shallow breathing, sharp chest pain, patient has previous cardiac problems and could recognize. He also reports feeling fatigued and flushed (hot flashes), body aches, headache mildness, injection site pain
34 2021-01-06 pain in extremity 20 minutes after got a rash in the neck, took allegra 180mg, same day 1 hour after same left arm pai... Read more
20 minutes after got a rash in the neck, took allegra 180mg, same day 1 hour after same left arm pain, next day shivers, chills, body aches took Tylenol 1gr every 8 hours
34 2021-01-06 tingling Left leg paresthesias. Isolated to lateral aspect of lower leg and stops at ankle. Has been ongoing ... Read more
Left leg paresthesias. Isolated to lateral aspect of lower leg and stops at ankle. Has been ongoing for about 3 weeks off and on. It is intermittent and did go away for a week or so but recently returned. It has not progressed and appears to be localized.. Evaluated by neurology 1 week after symptoms with a normal neurological exam.
34 2021-01-06 cold extremities, tingling Felt Cold tingling in 4th and 5th Fingers to right hand Narrative: Pt at on site 15min observations... Read more
Felt Cold tingling in 4th and 5th Fingers to right hand Narrative: Pt at on site 15min observations immediately after receiving Covid-19 Vaccination Informed monitor staff of 4th and 5th finmgers on right have felt cold Monitor checked VS: BP=134/85 P=73 O2-98% BP=127/74 P=73 BP-115-75 P=73 O2-am98% Situation resolve by 1045
34 2021-01-07 burning sensation, tremor feeling like he was going to pass out; throat was really dry within 15 minutes; Was very shaky. He w... Read more
feeling like he was going to pass out; throat was really dry within 15 minutes; Was very shaky. He was not falling over but had to be very careful with his steps.; burning sensation like a really bad acid reflux in chest that went to his back; he felt off. It is hard to explain.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 31Dec2020 07:20 at single dose for covid-19 immunization. Medical history included ongoing acid reflux, gout, anxiety depression. Ongoing Concomitant medication included allopurinol from Dec2020 for Gout, fluoxetine hydrochloride (PROZAC) at 20mg daily from Dec2020 2 weeks ago for Anxiety depression, omeprazole from Dec2020 3 weeks ago for Acid reflux (esophageal), calcium carbonate (TUMS ANTACID) from 2019 as needed for acid reflux. He experienced some unusual side effects that were not listed on the web. His boss advised him to call. Within a few minutes on 31Dec2020 after getting the vaccine he was feeling like he was going to pass out but didn't. His throat was really dry within 10-15 minutes on 31Dec2020. He was very shaky. He was not falling over but had to be careful with his steps. After getting the vaccine you have to sit and be monitored for 15 minutes. After that he was ok enough. He thought this was an expected reaction. He usually reacted to things though he didn't know why. He did fine with the flu shot. He had burning sensation like a really bad acid reflux in chest that went to his back on 31Dec2020. His throat was no different compared to like when you were going to get sick. He had drank a ton of water and his throat was still dry. He was not shaky but he felt off. It was hard to explain. Investigation assessment was no. The outcome of shaky and feeling like he was going to pass out was recovered on 31Dec2020, of dry throat was not recovered, of burning sensation was recovering, of others was unknown. Information on Lot/batch number has been requested.
34 2021-01-07 feeling cold, feeling hot Light-headedness, dizziness, headache. Feelings of being cold/hot with high lability. Facial press... Read more
Light-headedness, dizziness, headache. Feelings of being cold/hot with high lability. Facial pressure. Exacerbating throughout the day and continuing into the following day.
34 2021-01-07 tingling, flushing Became extremely flushed; tingling in hands and feet; disorientation; This is a spontaneous report f... Read more
Became extremely flushed; tingling in hands and feet; disorientation; This is a spontaneous report from a non-contactable nurse (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0140/expiration date unknown), via intramuscular route of administration, on 28Dec2020 (at the age of 34 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included Gastrooesophageal reflux disease (GERD), Attention deficit hyperactivity disorder (ADD), Generalised anxiety disorder (GAD). The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included esomeprazole sodium (NEXIUM), venlafaxine hydrochloride (EFFEXOR), 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. On 28Dec2020, at 09:00 PM, the patient became extremely flushed, tingling in hands and feet, disorientation. Treatment was received for the events became extremely flushed, tingling in hands and feet, disorientation included Diphenhydramine 50mg @2200 and again at 0200. The outcome of the events became extremely flushed, tingling in hands and feet, disorientation was recovered on unknown date. Since the vaccination, the patient had not been tested for COVID-19.; 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 extremely flushed, tingling in hands and feet and disorientation 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 chemistry panel and 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.
34 2021-01-07 tremor Approximately 12 hours post 2nd injection systemic rigors, uncontrollable tremors, tachycardia, seve... Read more
Approximately 12 hours post 2nd injection systemic rigors, uncontrollable tremors, tachycardia, severe tachypnea, nausea, fever >103F, severe diaphoresis. Most acute reaction lasted 8-12 hours. Sub-acute reaction of mild fever, generalized ache, and malaise 48 hours post. I am a health care provider, Certified Registered Nurse Anesthetist (CRNA).
34 2021-01-09 feeling hot After 15 minute observation states, feels hot, dizzy "off", B/p135/90, HR 74, 02Sat 98%, monitored f... Read more
After 15 minute observation states, feels hot, dizzy "off", B/p135/90, HR 74, 02Sat 98%, monitored for additional 15 minutes symptoms resolved, b/p 124/62, HR 69 and 02 Sat 98%.EE was able to return to work
34 2021-01-09 numbness and pain in extremities Experiencing moderate to severe ulnar nerve neuropathy or cubical tunnel syndrome (aka funny bone) s... Read more
Experiencing moderate to severe ulnar nerve neuropathy or cubical tunnel syndrome (aka funny bone) since receiving first shot, worse after 2nd
34 2021-01-10 weakness Vaccine recipient reported that 10 hours post vaccination they experienced fevers, chills, confusion... Read more
Vaccine recipient reported that 10 hours post vaccination they experienced fevers, chills, confusion, body aches, headaches, nausea, GI distress, generalized weakness and blunted cognitive processing. On a follow-up call on 1/11/2021, the vaccine recipient reported that their symptoms have resolved. Pfizer-BioNTech COVID- 19 Vaccine EUA.
34 2021-01-10 weakness Weakness Body aches Headache
34 2021-01-10 hot flush Pfizer BioNTech COVID 19 Vaccine EUA- All at once became flush, hot , dizzy & nausea, abdominal pai... Read more
Pfizer BioNTech COVID 19 Vaccine EUA- All at once became flush, hot , dizzy & nausea, abdominal pain & extreme dizziness. Went directly to MD who said it was a fairly normal side effects post COVID vaccine. Instructed to take Zofran APAP and if symptoms became worse to take Benadryl and my epi pen and seek emergency Tx. AT home N&V and abd. pain continued with extreme fatigue and chills. Continued the following day but mild. 1/7/21 symptoms relieved. Body & head feels fuzzy but no illness.
34 2021-01-10 migraine Headache, Myalgia, then next day migraine, fatigue, chills on/off, joint aches Narrative:
34 2021-01-10 nerve pain Two weeks after receiving the vaccine, I started noticing nerve pain in my left arm. The next day I ... Read more
Two weeks after receiving the vaccine, I started noticing nerve pain in my left arm. The next day I had a few red blisters on my arm, which began to spread along my arm over the next couple of days. I then went to the doctor on a Friday (18 days after receiving the vaccine), and he diagnosed me with Shingles and I was started on Valtrex and gabapentin.
34 2021-01-12 weakness Extreme chills, generalized weakness, headache, low back pain.
34 2021-01-12 flushing Headache fatigue, chills, slight sore throat; next day, also felt flushed, headache worse
34 2021-01-13 pain in extremity right arm pain, fever of 100.9 and Achy. Tylenol taken on 1/13/21 no improvement.
34 2021-01-14 flushing, weakness Approximately two hours after receiving the second dose of the COVID-19 vaccine, the patient complai... Read more
Approximately two hours after receiving the second dose of the COVID-19 vaccine, the patient complained of shortness of breath, feeling flushed, throat burning, tongue swelling and numbness, elevated heart rate, diaphoresis, dry mouth, weakness, and reddened skin. Patient was still in the facility where he received the vaccine and was immediately taken to the Emergency Department. The patient received Pepcid 20 mg by mouth, Benadryl 25 mg by mouth, and Predisone 40 mg by mouth.
34 2021-01-14 tremor Became very light headed; cold chills with shaking for 45-60 minutes; cold chills with shaking for 4... Read more
Became very light headed; cold chills with shaking for 45-60 minutes; cold chills with shaking for 45-60 minutes; Sweating for next 12 hours; Date of start of drug: 08Jan2021, Dose number: 2; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm, on 08Jan2021 08:30, at single dose, for COVID-19 immunization, in the doctor's office/urgent care. Medical history included depression, anxiety and COVID-19, all on unspecified dates. The patient has no known allergies. Concomitant medication included vilazodone hydrochloride (VIIBRYD 40 mg) and folic acid 1 mg. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm, on 19Dec2020 12:30, at single dose, for COVID-19 immunization. On 08Jan2021 at 21:00 (reported as 12 hours after the shot), the patient became very light headed. He experienced cold chills with shaking for 45-60 minutes and was sweating for next 12 hours. The patient had no fever. All events subsided by 10:00 next day, 09Jan2020. The patient received no treatment for the events. 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. The outcome of the events was recovered on 09Jan2020 at 10:00.
34 2021-01-18 pain in extremity, numbness Instant arm soreness and numbness. Arm muscle pain from about 2pm until about 9pm. Developing fatigu... Read more
Instant arm soreness and numbness. Arm muscle pain from about 2pm until about 9pm. Developing fatigue and headache by 2. At 9pm started to have sever rigors and had to move to a bed. Rigors for several hours with fever coming and going. Mild hallucinations while in bed and severe sweating. Woke up with left eye not responding but still had vision. Headache only on left side of head with severe pressure. Right sight felt normal. Right eye normal. Seemed like mix between edema and slight bell's pallsy. Could still move left side mouth and forehead. Eye was not responsive. Eye resolved after 2 days. Return to 100% about 96 hours after dose.
34 2021-01-18 tingling, tremor, cold sweat 1. Shaking 2. Whole body tingling 3. Left arm tense (injection was provided in right arm) 4. Felt c... Read more
1. Shaking 2. Whole body tingling 3. Left arm tense (injection was provided in right arm) 4. Felt clammy Walked over to hospital attached to the facility and was discharged the same day. All symptoms resolved.
34 2021-01-19 tingling Patient reported left sided tingling of the face and tongue starting approximately 30 minutes after ... Read more
Patient reported left sided tingling of the face and tongue starting approximately 30 minutes after vaccination and improved over a course of 30 minutes.
34 2021-01-21 tenderness Felt generalized malaise and left axillary lymphadenopathy one day after the vaccine (the very next ... Read more
Felt generalized malaise and left axillary lymphadenopathy one day after the vaccine (the very next morning). Took acetaminophen and was back to normal two days after the vaccine except for a very tender, enlarged left axillary lymphadenopathy that is persisting, now four days since the vaccination.
34 2021-01-23 pain in extremity I was lightheaded after receiving the shot, remained at the site for approximately 45 minutes. I con... Read more
I was lightheaded after receiving the shot, remained at the site for approximately 45 minutes. I continue to have a rash on my upper back indicative of an allergic reaction. Left arm was sore for first two days, soreness has dissipated. Still have a small lump on left arm where shot was received.
34 2021-01-26 seizure, unresponsive to stimuli Patient had vaccine administered by PA and was walking to do his observation period and stopped to g... Read more
Patient had vaccine administered by PA and was walking to do his observation period and stopped to get water from a fountain and leaned forward then fell to the floor was unresponsive and had an approximate 20 sec GTC seizure when the seizure was over he came to and was very confused and diaphoretic for approximately 15 minutes after the seizure. 911 was called by RN, and EMS came to assess the patient while waiting patient was placed into a wheelchair by multiple staff and taken to a cot where oxygen was applied. Vitals were taken and vitals were stable. EMS took blood sugar upon arrival that was stable. Patients sister has significant history of seizures but patient has never had a seizure before. Once patient was no longer sweating, pale and confused he was observed for half and hour. His parents came to get him and drove him home from the event. Patient was stable talking and no confusion or SOB or other symptoms after the half hour and patient was released to his father to drive him home and to monitor him for other symptoms.
34 2021-01-27 night sweats About 1 day after the shot experienced fatigue, myalgias, fever, night sweats, chills, and sleepines... Read more
About 1 day after the shot experienced fatigue, myalgias, fever, night sweats, chills, and sleepiness.
34 2021-01-27 unresponsive to stimuli Client became unresponsive for about 15 seconds after sitting in the observation area. He was pale a... Read more
Client became unresponsive for about 15 seconds after sitting in the observation area. He was pale and diaphoretic but came to almost immediately and was AO x4. BP was 128/74. Client reported having a history of "passing out" with needles prior but it had been years since that had happened. He was observed until 4:14pm and EMT observer on site took a final BP: 120/84 and walked him to his car. He had a steady gait walking to the car and ate a muffin before driving away.
34 2021-01-28 pain in extremity Fever; fatigue; headache; sore arm; This is a spontaneous report from a contactable other health pro... Read more
Fever; fatigue; headache; sore arm; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176), via an unspecified route of administration at right arm on 16Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at right arm on 27Dec2020 at 12:00 for COVID-19 immunization and experienced sore arm. On an unspecified date after second dose, the patient experienced sore arm, fever, fatigue, headache. The patient outcome of the events was recovered.
34 2021-01-28 tingling Lightheadedness, rapid breathing, tingling sensation all over the body, sudden drop in blood pressur... Read more
Lightheadedness, rapid breathing, tingling sensation all over the body, sudden drop in blood pressure to 80/50. Lasted about 20 minutes and then gradually subsided without medical treatment .
34 2021-01-29 weakness Had covid before in march. On first shot had fever and chills for 2 days. Still feel lousy and wea... Read more
Had covid before in march. On first shot had fever and chills for 2 days. Still feel lousy and weak. Feels like a strong immunogenic response. Not sure I want to take second dose since colleagues that didn't have covid before had these symptoms after the second dose not the first. I had covid before and I have these symptoms now.
34 2021-01-30 pain in extremity -Mild-moderate fatigue -Moderate bilateral upper body soreness, specifically axillary and neck areas... Read more
-Mild-moderate fatigue -Moderate bilateral upper body soreness, specifically axillary and neck areas with lymphadenopathy -Mild-moderate fever (99.7*F-100*F) -Mild-moderate bilateral upper extremity peripheral hypersensitivity (burning/pain with light touch from elbows to hands)
34 2021-01-31 pain in extremity Sore arm; This is a spontaneous report from a contactable other health professional (HCP). A 34-year... Read more
Sore arm; This is a spontaneous report from a contactable other health professional (HCP). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:00 on right arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm after the first dose on 27Dec2020. There was no treatment received for the event. The outcome of the event was recovered on an unspecified date.
34 2021-01-31 tingling Patient received 1st COVID vaccine (Pfizer) at approx. 0730. 10 minutes later noted bilateral hand ... Read more
Patient received 1st COVID vaccine (Pfizer) at approx. 0730. 10 minutes later noted bilateral hand tingling, bilateral foot tingling and left leg tingling. minimal pain at injection site, sent to ED. No difficulty breathing, speaking swallowing, no rash, no injection site change, no n/v. no vital sign changes of concern, no signs of typical allergic reaction. Normal neuro exam and symptoms spontaneously improving. Briefly observed in ED and discharged.
34 2021-02-03 numbness second COVID vaccine on 1/13/2021. Had a vaccine reaction on 1/14/2021 facial numbness, nausea & v... Read more
second COVID vaccine on 1/13/2021. Had a vaccine reaction on 1/14/2021 facial numbness, nausea & vomit x 5 days, chills, fever, HA.
34 2021-02-06 tingling, numbness and pain in extremities Mild neuropathy in last two fingers of injection arm. Neuropathy presents as "the tinglies" and is m... Read more
Mild neuropathy in last two fingers of injection arm. Neuropathy presents as "the tinglies" and is mild and transient. The neuropathy began approximately 2 weeks after the first dose. It was also experienced approximately 30 minutes after the second dose of the vaccine.
34 2021-02-07 feeling cold Extreme body aches, chills, headache, nausea, fatigue
34 2021-02-08 cold sweat, feeling cold Near syncopal episode, cool and clammy.
34 2021-02-12 numbness, nerve pain, pain in extremity Tendonitis, debilitating neuralgias leading to 2.5 weeks of missed work No issues immediately after... Read more
Tendonitis, debilitating neuralgias leading to 2.5 weeks of missed work No issues immediately after injection. About 12 hours later had severe arm pain limiting motion in L arm. Slowly improved but never resolved. Started to get worse again on day 7/8 with pain in deltoid, tricep, bicep, forearm. Should pain on day 10 while in bed reaching for covers - limited ability to do normal task (lift arm to turn on turn signal). No improvement with ibuprofen. Right shoulder pain started the following day. Was given medrol dose pack with some improvement for 2 days but bilateral shoulder pain worsened by day 2 of steroids. Heard pop in Right groin while sliding in bed on day 3 of steroids. Painful causing limping while walking for several days. On 1/13/21, severe pain in groin when standing leading to ER visit (Xray negative). MD described as tendonitis of adductor muscle. Pain radiated down leg to knee and to hip. The following day similar pains occurred in the left leg. Pain "bounced" between bilateral upper and lower proximal muscles and tendons. Had stiffening of R arm on 1/15/21 and 1/16/21 associated with numbness in hand. Went to ED again. inflammatory markers were negative. ANA was positive for RNP antibodies but the titer was low. rheumatoid factor low. TSH normal. ED MD said she would call it polymyalgia rheumatica but I was 40 years too young. Bouncing severe neuralgia type pain lasted about 2 weeks. It started to resolve with scheduled naproxen and daily physical therapy multiple times per day. It's 2/13/21 and I am still taking NSAIDs and doing PT and have residual shoulder impingement with upward arm movements, have limited ability to lift objects that I previously could and also have difficulty standing for rounds (critical care clinical pharmacist).
34 2021-02-18 flushing, feeling hot Patient feeling hot, flushed, diaphoresis, dry throat 15 minutes after vaccine; denies shortness of ... Read more
Patient feeling hot, flushed, diaphoresis, dry throat 15 minutes after vaccine; denies shortness of breath, rash, hives. BP 150/100, pulse 104; notes higher than normal although doesn't know normal. Given water, monitored. Continued with BP same; pulse down in high 80s, low 90s; bit better. Refused ED monitored. Monitored for another 15 minutes or so. Ambulated without lightheadedness; BP down to 140/90, pulse 90s. Felt about "80%"; stable; ready to go home. Lives with wife/children. Knows if not feeling well, seek medical attention.
34 2021-02-28 pain in extremity Severe joint pain in left arm - specifically elbow, hand
34 2021-03-03 pain in extremity Very mild arm soreness. Onset overnight. Soreness at injection site and when raising arm that was in... Read more
Very mild arm soreness. Onset overnight. Soreness at injection site and when raising arm that was injected. No others symptoms.
34 2021-03-04 tremor Lethargy; Muscle and Joint Pain; Muscle and Joint Pain; random Tremors; This is a spontaneous report... Read more
Lethargy; Muscle and Joint Pain; Muscle and Joint Pain; random Tremors; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 31Jan2021 10:45, at single dose, for COVID-19 immunization. Medical history included HIV undetectable. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient has no allergies to medications, food, or other products. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY); clonazepam; divalproex sodium (DIVALPROEX SODIUM ER); and lurasidone hydrochloride (LATUDA). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 01Feb2021, the patient experienced lethargy, muscle and joint pain, and random tremors. No treatment was given for the events. The patient underwent lab test which included Blood HIV RNA on an unspecified date with result HIV undetectable. The outcome of the events was not resolved. Information on the lot/batch number has been requested.
34 2021-03-05 muscle spasms, nerve pain Varicella resurgence, shingles on back and spine causing severe muscle cramping and nerve pain.
34 2021-03-09 feeling hot After receiving the Pfizer Covid vaccine at 11:43 AM, we had a patient alert one of the technicians ... Read more
After receiving the Pfizer Covid vaccine at 11:43 AM, we had a patient alert one of the technicians (at 11:50 AM)that he wasn't feeling well. He said that he felt a little dizzy and hot and started to feel nauseous. The pharmacist gave him a cold compress and had him lie on the ground and elevate his feet. After about 10 minutes the patient said he felt fine so we helped him back in his chair and asked that he stay longer for us to monitor him. He waiting an additional 15 minutes and said he felt fine and left.
34 2021-03-10 numbness Racing heart rate 30-45 minutes after injection. Also mild facial numbness on upper neck and jawline... Read more
Racing heart rate 30-45 minutes after injection. Also mild facial numbness on upper neck and jawline to ears. No difficult breathing at any point. Called 911 and pulled over. Evaluated by Fire/EMS and found no evidence of severe anaphylaxis. All vitals (except elevated heart rate) were normal.
34 2021-03-11 feeling cold pt reports shortly after sitting in the observation he felt dizzy and felt " like the vaccine was tr... Read more
pt reports shortly after sitting in the observation he felt dizzy and felt " like the vaccine was traveling through my body". Pt reports that he began to feel cold and had a brief episode of shortness of breath. RN nurse observer came over an stabalized pt and called for assistance. Pt was pale , diaphoretic and had bluish tinge to face upper extremities cap refill > 3 seconds. negative for facial swelling, skin redness, rash, chest pain, SOB, or NV. VSS EMS activated. after approximately 15 min. pt reported that he was feeling much better. EMS escorted pt out to ambulance for further evaluation.
34 2021-03-11 numbness Numb and tingling sensation, primarily in arms and face, later whole body. 50mg Benadryl has made it... Read more
Numb and tingling sensation, primarily in arms and face, later whole body. 50mg Benadryl has made it slightly better but it fades in and out throughout the day
34 2021-03-11 pain in extremity Left arm was incapacitated for nearly a week after the initial injection. Arm could not be lifted mo... Read more
Left arm was incapacitated for nearly a week after the initial injection. Arm could not be lifted more than a few inches away from torso, and pain felt like severe deep cramping constantly. No bruising or mark at the site of the injection just severe muscle pain that affected all movement and sleep. After one week I regained more mobility but still had severe pain in the shoulder muscles around injection site. At the 3 week mark I have more mobility but still struggle with a full range of motion and lifting anything more than a few pounds.
34 2021-03-11 tingling Numbness on tongue, tingling on face. Reported same symptoms as allergic reaction to shellfish. O... Read more
Numbness on tongue, tingling on face. Reported same symptoms as allergic reaction to shellfish. Observed and symptoms resolved within 30 minutes. Released home
34 2021-03-15 tingling, flushing 8 days after the 2nd dose of the pfizer, I started having heart rate increases where my heart rate i... Read more
8 days after the 2nd dose of the pfizer, I started having heart rate increases where my heart rate increased from my normal rate all the way up to 160bpm+. This has continued now for almost 2 weeks and also the start of additional symptoms where I feel flush, my body tingles, chest tightness, heaviness in my legs, shortness of breaths.
34 2021-03-16 feeling hot Syncope episode and feeling warm right before event
34 2021-03-16 cold extremities Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening ,p... Read more
Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening ,patient received 2nd vaccine today, during observation patient complained of feeling light-headed, sweaty , and hot, his skin felt cool to touch and he was pale in color, patient transferred to wheelchair onto stretcher, Vitals taken at 445p, BP-98/58 ,P-54, O2- 98. T- 98.6, R- 16, patient given water and he is drinking currently, at 449p VS rechecked, BP - 131/96, P- 82, O2- 94, R- 20, T- 97.7, 5pm BP- 133/94, P- 81, R- 20, O2- 97%, T- 97.8, 515p, BP- 128/ 94, P- 77, R- 19, T- 98.2, O2- 98% patient reports feeling better and continues in observation. He was discharged without incident. He was provided with Vaccine Information Sheet and instruction to access the V-Safe system.
34 2021-03-17 tingling 1100 Patient noticed tingling in right jaw 5 mins after receiving vaccine. Upon assessment patient v... Read more
1100 Patient noticed tingling in right jaw 5 mins after receiving vaccine. Upon assessment patient vital signs were BP: 146/98, O2: 97%, HR 81. Tingling in jaw doesn't radiate anywhere in his face. After assessment and sitting for a few minutes, tingling in face started to subside. Patient feels he is going to be ok. Doesn't need any other further supervision. Patient waited remainder of 15 mins and left with no further issues.
34 2021-03-18 feeling hot, unresponsive to stimuli Patient is a 34 year old male with a past medical history of asthma who presented to the vaccine sit... Read more
Patient is a 34 year old male with a past medical history of asthma who presented to the vaccine site today for his first dose of the vaccine. He received his dose at about 1710 and went t o observation area for his 15 min wait. About 5 minutes into his wait he reports feeling lightheaded and feeling hot then had a syncopal episode with loss of consciousness and fell out of his chair. He hit the left side of his head on the floor. This writer her a loud thud and looked out to see him on floor. I immediately ran over to him. He was unresponsive to tactile and verbal stimuli. He finally regained consciousness with sternal rub. He was out for about 30-45 seconds.
34 2021-03-18 pain in extremity, numbness excessive heart beating began after about 1 hour since had been vaccinated nausea - still continuing... Read more
excessive heart beating began after about 1 hour since had been vaccinated nausea - still continuing as of morning of 3/19 with every food consumption, cannot hold food spontaneous fever, mostly in the evenings numbness and soreness in left arm within first two days
34 2021-03-21 cold extremities Anaphylactic reaction (throat swelling), sweaty, cold skin, elevated blood pressure (211/137 mmHg) g... Read more
Anaphylactic reaction (throat swelling), sweaty, cold skin, elevated blood pressure (211/137 mmHg) gradual onset within 15 minutes of vaccine administration.
34 2021-03-22 tingling 13:45 patient received first Pfizer covid vaccine. Began to to complain of throat dryness and extrem... Read more
13:45 patient received first Pfizer covid vaccine. Began to to complain of throat dryness and extremity tingling shortly after while in observation post vaccine. Patient taken to private room and evaluated by MD. BP 150's/90's,HR slightly tachy with normal rhythm, o2 @100%RA. Patient continued to express dryness of throat and tongue and feeling swollen, also continues to mention tingling of body. Patient with hx of and also verbalized anxiety, @ 14:35 25mg of oral diphenhydramine was administered to patient, patient reported feeling better soon after. Bp lowered to 140's/80's and pulse to 70's-80's, and 02 remained at 100%RA. @15:07 patient expressed feeling back to normal, clinician gave home precautions and patient proceeded to go home. MD reported this as "mild anaphylaxis", patient will not be receiving 2nd dose
34 2021-03-23 feeling cold General fatigue/soreness started the evening of 3/23/2021. Experienced chills, fatigue, body aches, ... Read more
General fatigue/soreness started the evening of 3/23/2021. Experienced chills, fatigue, body aches, and headache the morning of 3/24/2021. Tylenol helped to manage these symptoms but they have still not abated.
34 2021-03-23 pain in extremity fainted; severe headache; Chills; body aches; arm pain; This is a spontaneous report received from ... Read more
fainted; severe headache; Chills; body aches; arm pain; This is a spontaneous report received from from a contactable consumer (patient). A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Mar2021 at 14:00 (Lot Number: EN6198) (at 34-year-old) at single dose in arm left for COVID-19 immunization. The patient's medical history was not reported. No allergy to medications, food, or other products. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications within 2 weeks of vaccination included testosterone cypionate, chorionic gonadotrophin (HCG), rosuvastatin, and tadalafil (CIALIS), all taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Feb2021 at 14:00 (Lot Number: EN6201) at single dose in arm left for COVID-19 immunization. He woke up in the middle of the night (4:00 am on 06Mar2021) after getting his second vaccine with severe headache, chills, body aches and arm pain. After getting up and using the bathroom, he went to take his temperature and fainted. The events were reported as non-serious, while resulted in emergency room/department or urgent care, treatment included intravenous (IV) fluids, paracetamol (TYLENOL). The outcomes of the events were resolved on an unspecified date in Mar2021. Information on the expiration date of vaccine has been requested.
34 2021-03-25 tremor Severe tremor and chills; near fainting; blood in urine and stool.
34 2021-03-27 feeling hot Pt states he felt very hot and sweaty. Pt presented as pale and diaphoretic. Pt was moved to the exa... Read more
Pt states he felt very hot and sweaty. Pt presented as pale and diaphoretic. Pt was moved to the exam area and monitored. Pts vitals are stable. Pt states he?s feeling better and wants to leave. Pt didn?t require transport to hospital.
34 2021-03-27 tremor, tingling Pfizer-BioNTech COVID-19 Vaccine - One day following administration of the Pfizer COVID-19 vaccine, ... Read more
Pfizer-BioNTech COVID-19 Vaccine - One day following administration of the Pfizer COVID-19 vaccine, pt repoted chills, body aches, shakiness in his hands and tingling in his feet and hands. He treated with Tylenol, rest and fluids and opted to also contact his physician to report the symptoms as he is currently being tested for a hereditary immune system disorder.
34 2021-03-28 numbness Upon waking up in the morning, day after 1st injection, I've been experiencing numbness on my chin, ... Read more
Upon waking up in the morning, day after 1st injection, I've been experiencing numbness on my chin, and pain behind my jaw, lower left side around where my tonsil is. Only hurts when I try to open jaw wide or stick my tongue out far. Pain level around 4 out of 10. Symptoms still present 4 days after injection and have my no change in severity.
34 2021-03-30 pain in extremity Patient experienced a sore arm and dizziness five minutes after receiving the vaccine. He never lost... Read more
Patient experienced a sore arm and dizziness five minutes after receiving the vaccine. He never lost consciousness. He reported having not eaten anything since 6PM the night before. Patient was given food and water and recovered after about 30 minutes.
34 2021-03-30 unresponsive to stimuli Patient became syncopal approximately 10 minutes after injection. Patient was sitting in a chair an... Read more
Patient became syncopal approximately 10 minutes after injection. Patient was sitting in a chair and rolled off and onto the floor. He was unresponsive for several seconds until sternal rub performed. Patient woke and did not know where he was. Patient states he has a hx of vasovagal syncope.
34 2021-03-31 flushing, feeling hot Systemic: Dizziness / Lightheadness-Medium, Systemic: really over heated-Severe, Systemic: Flushed /... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: really over heated-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Gave patient cold water glucosetablet and took blood pressure. 118/70.patient felt fine after 5 min and left
34 2021-04-04 face paralysis, bell's palsy, mild one side paralysis Left side facial weakness due to Bells Palsy
34 2021-04-04 feeling hot Patient reported feeling hot and dizzy brought to the EMS room for observation. Doctor at bedside. p... Read more
Patient reported feeling hot and dizzy brought to the EMS room for observation. Doctor at bedside. patient denies chest pain shortness of breath or nausea. Vitals taken, blood sugar 103. Patient given some apple juice and discharged in no distress @ 8:50am.
34 2021-04-04 numbness, flushing Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Syst... Read more
Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient complain of tachycardia, sweating, left neck soreness, dry mouth and numb tongue approximately 10 minutes after administration. Recovered after 30 minutes. Per patient possibly anxiety induced.
34 2021-04-04 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA (administered on 03/26/21) Fever, chills, headache, general so... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA (administered on 03/26/21) Fever, chills, headache, general soreness all began on 03/27/2021. On 03/28/2021, I began to notice chest pain and simultaneous pain in my left arm on 03/28/2021. The fever, chills, headache, and general soreness subsided on 03/29/2021, but the periodic chest and arm pain persisted and continued to get worse. On 03/29/2021 I also had nausea/vomiting and sweating. On the morning of 03/30/2021 during an episode of chest and arm pain we went to the Emergency Department at. At the emergency department, they detected elevated troponin levels indicating damage to the heart muscle. I was rushed via ambulance for an emergency heart catheterization. I was admitted to the hospital and monitored while various other tests were performed. It was determined that there was inflammation of the heart muscle (myocarditis).
34 2021-04-06 pain in extremity Sore left arm, muscle soreness, fatigue waking up the next day. Around 24 hrs after vaccination, hea... Read more
Sore left arm, muscle soreness, fatigue waking up the next day. Around 24 hrs after vaccination, headache started, and lasted for ~8 hours. I took some advil around an hour before the headache stopped (really wish I'd taken it when I first felt the headache). I could feel the muscle soreness go away before the headache did. The headache felt like it moved from behind my eyes to the back of my head. I decided to only eat bits and pieces of stuff when I was feeling my worst because I was concerned that would make me feel nauseated (never did feel that way, so no idea if that made a difference). I drank probably 200oz of liquid throughout the day, but still felt dehydrated, even though I wasn't sweating. Did pee a lot though. Generally it was what I expected, but a friend who works at a hospital said I should report the info.
34 2021-04-06 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA. Symptoms included sore arm, fatigue/tiredness, headache, body... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Symptoms included sore arm, fatigue/tiredness, headache, body ache, slight chills, slight sore throat, fever, and slight stomach ache. Majority of symptoms lasted about 8 hours. Slight headache still exists. Took 2 Ibuprofen to help with pain(s) about 5 hours after symptoms started.
34 2021-04-07 cold sweat 1-2 MINS AFTER VACCINE ADMIN, FELT LIGHTHEADED, "SEEING STARS" CLAMMY. GIVEN WATER AND CRACKERS AND ... Read more
1-2 MINS AFTER VACCINE ADMIN, FELT LIGHTHEADED, "SEEING STARS" CLAMMY. GIVEN WATER AND CRACKERS AND BROUGHT TO OBS VIA WHEELCHAIR. FELT BETTER ONCE IN WHEELCHAIR. HAD ANXIETY PRIOR TO ARRIVAL TO SITE. 1139: BP 110/74 HR 90 RR 18 SATS 94% RA. FEELING BETTER PER PATIENT. 1145: BP 124/81 HR 88 RR 18 SITTING. PATIENT STATES BACK TO BASELINE. STANDING BP 131/71 HR 85. ESCORTED TO PERSONAL VEHICLE WITH NO REMAINING RESIDUAL.
34 2021-04-07 feeling hot received shot 0935a, 0940a patient started to feel lightheaded, hot, sweating; reports hx of this wi... Read more
received shot 0935a, 0940a patient started to feel lightheaded, hot, sweating; reports hx of this with anxiety and needle anxiety. brought back to obs, offered apple juice and water, laying down, patient feels some relief. 0945: bp 139/82 rr 20 hr 71 sats 95% on ra. feeling better per patient. 0950: bp 138/88 hr 77 rr 20 sats 98% on ra. 1000: bp 137/85 hr 71 rr 20 sats 97% on ra sitting up. patient states feeling back to baseline, s/s resolved. escorted with s/o to private vehicle.
34 2021-04-08 feeling cold Woke up with extreme dizziness to the point of almost losing balance and passing out. Mild nauseou... Read more
Woke up with extreme dizziness to the point of almost losing balance and passing out. Mild nauseous, and brief cold chills. Subsided after about 5 minutes.
34 2021-04-08 muscle spasms nine hours after injections: fever, muscle pain, nausea, chills, joint pain, headache, injection sit... Read more
nine hours after injections: fever, muscle pain, nausea, chills, joint pain, headache, injection site pain, vomiting, muscle spasms, lymph node appearance in neck, sleepiness, malaise, vivid dreams, unable to sleep well, or function.
34 2021-04-08 pain in extremity When I got the shot I felt okay for the rest of the day, but the injection site on my right arm hurt... Read more
When I got the shot I felt okay for the rest of the day, but the injection site on my right arm hurt a bit for the rest of the day. The next morning my right arm still hurt, but it was not worst. However my left hand and left elbow felt very stiff. When I tried to bend my left elbow it hurt a bit. When I tried to bend my fingers on my left hand it hurt very much. I couldn't even make a fist it hurt so much. I kept slowly bending my elbow and bending my fingers until the pain and stiffness would go away. Most of the pain and stiffness went away, but a little still remained. It feels like I have some kind of Arthritis in my left hand and left elbow, but I have never had it before. Since I got the COVID-19 vaccine, every time I wake up I have been experience the same thing.
34 2021-04-08 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
34 2021-04-09 seizure He had flu-like symptoms after receiving the vaccine on Monday 3/29. He woke up on Tuesday 3/30 with... Read more
He had flu-like symptoms after receiving the vaccine on Monday 3/29. He woke up on Tuesday 3/30 with fatigue and a low-grade fever. He was scheduled for a routine doctor's appointment late Tuesday afternoon. At the doctor's office he had a seizure, which caused him to lose consciousness for 15 seconds. Upon waking, he was transferred to the Hospital. He was released later that day. On Wednesday 3/31, he experienced a headache & went to the hospital. He was admitted and stayed in the hospital for 2 nights. An MRI found micro-bleeds on his brain. He was treated with lamotrigine and sent home with a prescription for 25mg/twice daily. He has a follow up appointment with a neurologist in 3 weeks.
34 2021-04-11 weakness Feeling unwell, dizziness/weakness, muscle pain, and difficulty breathing. Onset of symptoms under 1... Read more
Feeling unwell, dizziness/weakness, muscle pain, and difficulty breathing. Onset of symptoms under 1 hour from time of vaccination. EMS on site monitored patient and later released. No need for additional care or treatment.
34 2021-04-11 flushing Flushing, Sweating, Dizziness, BP87/50, HR70, RR18, given juice and monitored, left in stable condit... Read more
Flushing, Sweating, Dizziness, BP87/50, HR70, RR18, given juice and monitored, left in stable condition
34 2021-04-11 flushing Pt reports he felt lightheadedness, sweating, and flushing after receiving vaccine. Denies LOC. No p... Read more
Pt reports he felt lightheadedness, sweating, and flushing after receiving vaccine. Denies LOC. No previous reactions to vaccinations in the past. Pt had gatorade in hand at time of arrival to med obs #1. Pt able to stand and ambulate to stretcher from w/c independently without difficulty. Orthostatic VS obtained per MD request. No s/s of distress noted. VS at 1055: BP 131/74, HR 60, RR 17, O2 sat 96% on RA. VS at 1105: BP 130/73, HR 60, RR 16, O2 sat 99% on RA. VS at 1107: BP 142/68, HR 63, RR 16, O2 sat 98% on RA. VS at 1108: BP 149/78, HR 63, RR 17, O2 sat 98% on RA. Pt escorted to exit via w/c with staff.
34 2021-04-11 nerve pain, tingling 2-4 hours after the injection experienced ulnar nerve pain and paraesthesia, tingles and pins and ne... Read more
2-4 hours after the injection experienced ulnar nerve pain and paraesthesia, tingles and pins and needles sensation in pinky and ring finger of the right (injection side) hand. Over the course of 6 days the paraesthesia spread distally to both hands and feet and cheeks. Symptoms persist at day 38 accompanied by mild fatigue. Per my Dr's recommendation I've skipped the second dose. Reading a lot of folks online are experiencing tingles, paraesthesias and similar side effects. Worried that this may be nerve damage or cause chronic peripheral neuropathy. Completely healthy with no known medical issues prior to vaccination other than food allergies to certain seafood as a child.
34 2021-04-12 weakness Symptoms starting roughly 10 hours after vaccine, and lasting for 18-24 hours: High fever, chills, i... Read more
Symptoms starting roughly 10 hours after vaccine, and lasting for 18-24 hours: High fever, chills, intense body ache, joint pain (to the point of not being able to move), fatigue, headache, vomiting, diarrhea, abdominal pain, weakness/fainting
34 2021-04-12 weakness EMS providers approached by 34 y/o M pt c/o diaphoresis and feeling weak. Pt CAOx4 with a GCS of 15.... Read more
EMS providers approached by 34 y/o M pt c/o diaphoresis and feeling weak. Pt CAOx4 with a GCS of 15. Pt with normal patent airway with no visible signs of distress. Upon initial assessment, pt found to be diaphoretic. Pt moved to cot and full assessment performed and v/s obtained. P 84 regular, RR 18 non-labored, B/P 120/72, SpO2 98% RA. Pt denied CP, SOB, N/V/D. No other associated symptoms noted. Pt rested for approx 10 mins and stated he felt much better. Pt stated that he thought it might have been an anxiety reaction. Repeat vitals P 77 regular, RR 18 non-labored, B/P 128/P, SpO2 97%. Pt did not want to go to the hospital for eval and stated his wife could come pick him up. Pt informed to call emergency responders or go to the
34 2021-04-12 bell's palsy tongue felt numb on third day after receiving second shot for about 3 days then woke up 4/5/21 with ... Read more
tongue felt numb on third day after receiving second shot for about 3 days then woke up 4/5/21 with no movement to left side of face. went to urgent care and was diagnosed with bells palsy .
34 2021-04-12 cold sweat At approximately 1010 the client lied down on the bleachers and reported feeling dizzy and not well,... Read more
At approximately 1010 the client lied down on the bleachers and reported feeling dizzy and not well, he was also visibly clammy. He stated he usually feels that way after medical situations such as vaccinations and blood draws. Client was offered to go to a more private area and refused. MRC volunteer got cool paper towels to place on his forehead and client requested to continue to lay down where he was. After about 10 minutes client wanted to sit back up and reported he was not as dizzy any more. He sat up with ease and no difficulty and he stated he was not feeling as dizzy. After sitting for a few minutes he received notification that his observation period was over and he stated that he was ready to go. I assisted him down the bleachers and out of the outreach facility, he had a steady gait and stated he was feeling, much better. He left the facility with his partner.
34 2021-04-12 feeling hot, tingling Feeling warm tingling in face and feet seemed anxious. One dose of Benadryl 25 mg cap given plus wat... Read more
Feeling warm tingling in face and feet seemed anxious. One dose of Benadryl 25 mg cap given plus water given
34 2021-04-12 pain in extremity, hot flush, numbness Within 15 minutes of receiving my first dose of the Phizer vaccine a portion of my arm went numb as ... Read more
Within 15 minutes of receiving my first dose of the Phizer vaccine a portion of my arm went numb as if I received Novocain from the Dentist. This only impacted the portion of my arm between my elbow and shoulder. My hand was not numb. My entire head also felt as if I was coming off Novacain. I would also get hot and cold flashes. My upper body was itchy. I also felt like I was having circulation issues (like if you sleep in a weird position). The tips of my fingers and toes would be cold. I believe the Novacain issue was attributable to the shot but some of my other issues might have been the result of a panic attack as a result of my face going numb. I went to the ER but by the time I saw the doctor around 12:00pm most of these symptoms were going away. I went to bed and woke up much better. I can feel my arm now. It just feels sore but what I expected it to feel like after the shot. The Novacain feeling in my head went away now I just have a mild headache. The key symptom I was concerned about was the Novacain feeling given my wife also received the shot and did not have this experience.
34 2021-04-14 cold sweat PT. PASSED OUT AFTER RECIEVING THE VACCINE. WHEN HE CAME AROUND HE WAS SWEATY AND CLAMY. EMT WAS CA... Read more
PT. PASSED OUT AFTER RECIEVING THE VACCINE. WHEN HE CAME AROUND HE WAS SWEATY AND CLAMY. EMT WAS CALLED. HE ORIGINALLY HAD LOW BLOOD PRESSURE. WEHN THE EMT SHOWED UP ALL VITALS CAME BACK GOOD.
34 2021-04-14 numbness, pain in extremity Main symptom: Around 10 hours after receiving the vaccine, my right ankle felt slightly numb. I also... Read more
Main symptom: Around 10 hours after receiving the vaccine, my right ankle felt slightly numb. I also had a sharp, painful shooting pain in the middle of the sole of my foot that lasted less than a second. As the night progressed, the numb area spread slowly to other parts of my foot. When I woke up the following day (today), I was surprised to discover I was not only still numb, but the numbness had spread across the entire outside of my right foot (from my ankle to 3/4 of the distance to my pinky toe). Now, several hours later at 8:30pm, the numbness reaches all the way from near my pinky toe on my right foot up to the bottom of my calf. All of the numbness is isolated to the right side of my right lower extremities and has not crossed over to the middle of any of my extremities yet. I can also feel a slight numb sensation in my left index finger stretching to the base of my left thumb, but it isn't nearly as bad as my right foot. I haven't felt any addition sharp shooting pains. Numbness aside, I had a pretty bad headache from about 4pm to 10pm yesterday, and when I closed my eyes saw what appeared to be mild hallucinations (green and red streaks that disappeared pretty quickly, and were only visible when my eyes were closed). I'm no longer having the visual symptoms, but the numbness is getting worse by the hour. I have NEVER had any of these symptoms before in my life, and did nothing out of the ordinary yesterday or today in terms of food or physical activities. I take no medications.
34 2021-04-14 pain in extremity First dose of vaccine received on April 6. Soreness in arm for remainder of day, slight fever to 100... Read more
First dose of vaccine received on April 6. Soreness in arm for remainder of day, slight fever to 100.5 that night. No symptoms for remainder of week. Slight cough began in the morning on April 12, no other symptoms at that point. Woke up on April 13 with 101.4 F temperature, and throat soreness that made swallowing incredibly painful. Sore throat has made continuous sleep nearly impossible for the next two days (so far), as whenever I swallow I wake myself up, which happens every 10-15 minutes. This has resulted in general fatigue throughout the day. Fever, sore throat, coughing all get worse at night time. Average temperature during the day has been 99.5 F, while temperature readings after 10 PM have been in the 101-102 F range. Appears to be semi-breakthrough SARS-CoV-2 infection (i.e. after first dose of vaccine, but before second dose), based on timing of symptoms and subsequent positive PCR test.
34 2021-04-14 tingling Post vaccine pt experienced heart palpitations, sob and lightheadedness. Pt arrived to med obs at 1... Read more
Post vaccine pt experienced heart palpitations, sob and lightheadedness. Pt arrived to med obs at 1004 via wc. Upon arrival pt reports heart palpitations, extremities tingling. lips tingling and mild throat tightness. Vitals obtained and monitored. Pt denies pruritus, no wheezing noted upon auscultation. Symptoms resolved on their own. Per on site physician pt ok to be released. Pt released by self at 1020. Vitals as follows: 1005 BP 153/102 HR 88 RR 14 SPO2 97% 1010 BP 144/95 HR 86 RR 16 SPO2 98% 1015 BP 138/89 HR 79 RR 16 SPO2 98% 1018 BP 142/95 HR 87 RR 16 SPO2 96%
34 2021-04-14 tremor Around 11:30 pm, began experiencing symptoms. By 12:30am, had extremely severe/uncontrollable chil... Read more
Around 11:30 pm, began experiencing symptoms. By 12:30am, had extremely severe/uncontrollable chills and shakes. I took Advil and the shakes lasted approx another 20 minutes. Tried to take temperature, but had to physically hold my mouth shut , which was unsuccessful. The thermometer registered 95°. Cycles of chills/sweats/shakes continued throughout the night.
34 2021-04-15 weakness EMS providers approached by 34 y/o M pt c/o diaphoresis and feeling weak. Pt CAOx4 with a GCS of 15.... Read more
EMS providers approached by 34 y/o M pt c/o diaphoresis and feeling weak. Pt CAOx4 with a GCS of 15. Pt with normal patent airway with no visible signs of distress. Upon initial assessment, pt found to be diaphoretic. Pt moved to cot and full assessment performed and v/s obtained. P 84 regular, RR 18 non-labored, B/P 120/72, SpO2 98% RA. Pt denied CP, SOB, N/V/D. No other associated symptoms noted. Pt rested for approx 10 mins and stated he felt much better. Pt stated that he thought it might have been an anxiety reaction. Repeat vitals P 77 regular, RR 18 non-labored, B/P 128/P, SpO2 97%. Pt did not want to go to the hospital for eval and stated his wife could come pick him up. Pt informed to call 911 or go to the
34 2021-04-15 discomfort, tingling, seizure Within an hour of receiving the vaccine, I began to feel "odd" (i.e heart racing, spine tingling, st... Read more
Within an hour of receiving the vaccine, I began to feel "odd" (i.e heart racing, spine tingling, strange sensations in my hands, and dizziness). At the hour mark, while trying to "walk it off" inside my backyard, things escalated quickly. As I came back inside, I suddenly collapsed and and lost consciousness. Luckily my best friend was with me and she described my behavior as a full on seizure (which I am not predisposed to). According to her, I was flopping around, spitting wildly and drooling all over my face, my eyes wide and glazed staring into nothing, lips turning blue. She immediately called 911 and within 5-10 minutes, two EMT's arrived and began to speak to me and take my vitals. For a good 15 minutes I couldn't sit up and had to lay on the ground, still extremely out of it - unable to think, merely in extreme discomfort similar to the most intense flu I've ever experienced. After a half hour or so, I sat up and was able to thank them for helping me and answer some of their questions. Over another 15 or so minutes they said all my vitals were perfect and they were not worried about me - sure I'd make a full recovery, which I hope I did. I am feeling MUCH better today. The reason I felt it so important to submit this report is because I had never heard of anyone experiencing side-effects that severe. Of course I had heard it could wipe you out, give you chills, aches, and exhaustion - but I had never heard that it could lead to a seizure so scary that my best friend thought I might be dying. I truly don't know what might have happened without her. People should know to have someone at home with them after the second dose. I am not over-exaggerating about my symptoms whatsoever. My body still hurts all over and I feel as if I went through some type of gauntlet yesterday. I absolutely do NOT want to discourage anyone from getting the vaccine, but I wish I had some notion that something so severe could happen to me.
34 2021-04-15 numbness, tingling Numbness and face tingling. Similar to the impact of novacaine when at the dentist. Symptoms start... Read more
Numbness and face tingling. Similar to the impact of novacaine when at the dentist. Symptoms started with minor tingling on tongue, then went to chin, then after a short period of time covered my entire lower left side of face from chin up through jaw and into ear. Extremely minor scratching and tingling in throat. Entire episode only lasted a few hours. Then was mostly gone.
34 2021-04-17 feeling cold, feeling hot, numbness, weakness At 1140, RRT was activated for a 34 y/o M that passed out for a few seconds. He stated, ?I felt like... Read more
At 1140, RRT was activated for a 34 y/o M that passed out for a few seconds. He stated, ?I felt like I was in a dream.? His eyes rolled back before passing out. When he was alert after his fainting episode, he stated that his right arm was numb and had c/o nausea, weakness, a brief moment of blurry vision, and ?feeling hot?. Head-to-toe assessment completed. Client was diaphoretic and pale. Client also reported that he was feeling hot and then feeling cold all of a sudden and this was ongoing. Client vaccinated on the R arm at 1130. NKA, no past medical hx. Does not take any medications but smoked marijuana just prior to his appointment. Vitals ? BP: 138/98, RR: 20, HR: 65, 0/0 pain. EMS called. Client?s condition improved during monitoring period but as EMS arrived, client began to feel same symptoms again but did not pass out. EMS arrived at 1149. Vitals when they arrived were: BP: 142/77, HR: 48. Client?s condition did not improve significantly but did not get worse. Client opted to have ambulance transport to Community ER to be further evaluated and treated. Client left vaccination clinic via Representative, accompanied by Fire Engine and unit @ 1200. Girlfriend, who came with client, followed client to hospital. Client left in stable condition, AA0x4, breathing even and unlabored, in no acute distress.
34 2021-04-17 pain in extremity Pain and throbbing in arm where I received the shot, especially the following morning. It?s been re... Read more
Pain and throbbing in arm where I received the shot, especially the following morning. It?s been recurring pain especially when I move my arm in certain ways. No health insurance at the moment, haven?t seen a physician about this or received an MRI. The more concerning though is recurring vertigo I?ve been experiencing. I have never had it before, but a few days after I?m receiving the dose my eyes started shaking involuntarily and I had difficulty keeping my balance. It went away after a bit, but has happened a number of times over the last two weeks. I?m obviously hoping it just goes away.
34 2021-04-17 seizure, unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-S... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient passed out the first time for about 15-20 seconds then was sat down. Patient passed out again the 2nd time with some convulsions. Paramedics came and took pt away.
34 2021-04-18 weakness, migraine Fever highest at 102. Chills. Body aches. Muscle aches. Severe migraine. Weakness.
34 2021-04-18 bell's palsy Bell Palsy started a couple weeks after my first Phizer vaccination
34 2021-04-18 feeling hot Patient, who has a h/o vasovagal reactions with injections was fine for 15 minutes, then started to ... Read more
Patient, who has a h/o vasovagal reactions with injections was fine for 15 minutes, then started to feel warm and slightly woozy. He did not have any loss of consciousness. VSS and he felt better quickly after placing him in a reclined position.
34 2021-04-19 mild one side paralysis, difficulty speaking My husband had stork like symptom on 16APR, starting at 11:30 am. He was in a conference call, and s... Read more
My husband had stork like symptom on 16APR, starting at 11:30 am. He was in a conference call, and suddenly felt dizzy, voice change, drooling, sleepy. When he came downstairs, he could not hold himself, and I noticed his mouth was tilted to the left with drooling, and weakness on his left side. We had him sitting in the chair and I drove him to the ER immediately.
34 2021-04-19 migraine Headache, chills, fever from 9:00am - 2:00pm day after vaccine. Extreme migraine from 2:00pm - 4:00... Read more
Headache, chills, fever from 9:00am - 2:00pm day after vaccine. Extreme migraine from 2:00pm - 4:00pm. Symptoms stopped very rapidly and did not come back.
34 2021-04-20 numbness, tingling minor symptoms, soreness at injection site and numbness and tingling at the fingers since the mornin... Read more
minor symptoms, soreness at injection site and numbness and tingling at the fingers since the morning and throughout the day
34 2021-04-20 seizure After receiving dose one of covid 19 vaccine on 3/19/21, patient experienced a tonic clonic seizure ... Read more
After receiving dose one of covid 19 vaccine on 3/19/21, patient experienced a tonic clonic seizure on 3/21/21 at 2pm. After receiving dose two of covid 19 vaccine on 4/8/21, patient experience a different kind of seizure on 4/10/21 at 11pm. Patient has history of epilepsy but is controlled and has not experienced a seizure in many years. the adverse even occured approx 2 days after each dose. Follow-up with Neurologist has determined that most likely the immune response to the vaccines triggered the seizures. Patient had EEG and has appointments for more testing including MRI.
34 2021-04-20 tremor Severe body/muscle aches approximately 19 hours after injection, accompanied by minor dizziness. Mod... Read more
Severe body/muscle aches approximately 19 hours after injection, accompanied by minor dizziness. Moderate fatigue. Took Tylenol to relieve side effect symptoms. Mild to moderate shakiness and shaky sensations then set in 24 hours after injection, most noticeable when trying to sleep and waking up.
34 2021-04-21 pain in extremity next day had leg pain and swelling on right side. over the next several days, significant bruising, ... Read more
next day had leg pain and swelling on right side. over the next several days, significant bruising, swelling and pain
34 2021-04-22 burning sensation, weakness I had a nasty zit on the back of my neck, popped it, and my immune response was extreme. Initial: It... Read more
I had a nasty zit on the back of my neck, popped it, and my immune response was extreme. Initial: Itching and burning through my neck and shoulders, and swollen lymph nodes in neck and collarbone. I began sweating at night profusely and losing weight. I have had a lot of trouble sleeping. These symptoms continued in 24-48 hour cycles of flare ups until 04/19/2021 but finally seem to be abating. Progression: secondary symptoms appeared over the course of the month such as full body joint soreness, weakness, stiffness, stabbing pains (in the neck, arms, chest, and abdomen), blood pressure spikes, dry/sore throat, dry eyes, difficulty swallowing. Symptoms are similar to arthritis or other autoimmune diseases. Night sweats continue but are lighter. Weight loss continues but slower. Sleeping remains irregular.
34 2021-04-22 flushing Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-M... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Under pharmacist observation for 45 minutes , fainted and light-headed 5 minutes, given bottle water for hydration . no other symptoms and fine after 45 minutes of observation
34 2021-04-22 muscle spasms Spasms in right arm. Vitals wnl, O2 sat 99%.
34 2021-04-22 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: 911 called to store by RN who administered vaccine. Patient was waiting 15 min after vaccine and passed out on floor about 5 min after receiving vaccine. RN reports he did not hit his head, was assisted to the floor. Regained consciousness about 1 min later. VSS, BP 127/75, P 97, R 18, O2 93%. \r\nEMS arrived and evaluated pt, glucose 88, reported sinus rhythm on ECG. Patient refused transport to ED by EMS or to go to ED for further evaluation. \r\nPatient stayed and had driver take him home.
34 2021-04-23 cold sweat aBOUT 10 MINUTES FOLLOWING THE vaccine, the patient lost consciousness and passed out, his hands wer... Read more
aBOUT 10 MINUTES FOLLOWING THE vaccine, the patient lost consciousness and passed out, his hands were clammy and he was pale. He needed to lay down with his legs elevated for about 20 minutes before improving. Shorlty after passing out, he also vomitted. His vitals were always stable and he never had trouble breathing. He later reported that he always passes out after blood draws.
34 2021-04-23 pain in extremity I started to notice a metallic taste in my mouth early Saturday morning. Soreness in the arm but it ... Read more
I started to notice a metallic taste in my mouth early Saturday morning. Soreness in the arm but it has decreased significantly.
34 2021-04-23 tremor Client shaking followed and stated he felt anxious. MD advised client to wait in observation area fo... Read more
Client shaking followed and stated he felt anxious. MD advised client to wait in observation area for extended observation. Client developed persistent dry non-productive cough. 50mg/1ml Benadryl ordered. Client symptoms improved. Client wife came to site to drive client home. Client declined transport to ER. Client advised that if symptoms worsen to seek emergency services.
34 2021-04-23 unresponsive to stimuli At approximately 6:00pm on 04/23/2021 patient during 30 minute observation had a witnessed syncopal ... Read more
At approximately 6:00pm on 04/23/2021 patient during 30 minute observation had a witnessed syncopal episode with loss of consciousness. Pt was assisted to stretcher during episode and assessed, presenting unresponsive initially, and then improved to AA&Ox4, airway patent, breathing normal and non-labored. Pulse bounding and thready with delayed perfusion. Pt skin pale, diaphoretic, and cool. Pt condition did not improve with oral hydration. EMS contacted via 911 for transport to the hospital. Pt administered 300ml IV Normal Saline via 18g catheter in left AC. Vitals as follows: (1800 91P, 112/58 16R, 98%)(1808 99P,90/50, 23R, 98%)(1812 109P, 94/50, 20R, 98%)
34 2021-04-24 feeling cold Muscle ache Fatigue Chills Indigestion Brain Fog Lightheadedness
34 2021-04-24 feeling cold I felt really tired after an hour of the shot. I woke up today sweating, but I also felt code. As of... Read more
I felt really tired after an hour of the shot. I woke up today sweating, but I also felt code. As of today (one day after the second shot) my right arm, shoulder, and armpit ache, my back and legs also ache.
34 2021-04-24 flushing, weakness Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Me... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Medium
34 2021-04-24 hot flush nausea; diarrhea; excessive sweating; chills; hot flashes; shortness of breath; chest tightness; ele... Read more
nausea; diarrhea; excessive sweating; chills; hot flashes; shortness of breath; chest tightness; elevated liver enzymes; blood pressure and heart rate were high. BP was approx 180/120; heart rate were high; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 19Mar2021 08:15 (Batch/Lot Number: ER2613) as a single dose for covid-19 immunisation. Medical history included asthma, IBS (irritable bowel syndrome), and allergies to shellfish, fish and seafood. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included glucosamine and cetirizine, all indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The COVID 19 vaccine was received in a hospital. Approximately 12:15 AM on 21Mar2021, the patient began to experience chest tightness, shortness of breath, nausea, diarrhea, excessive sweating, chills and hot flashes. The patient took himself to the emergency room (ER) on 21Mar2021. The patient also mentioned that his temperature was normal, but his blood pressure (BP) and heart rate were high. BP was approximately 180/120 (unit unspecified). The ER ran Chest X-Ray, EKG, CBC, CMP, Protime-INR, Magnesium, Troponin, Partial Thromboplastin Time and TSH. The results were normal ranges besides high heart rate and elevated liver enzymes. The adverse events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events received treatment for the adverse events which included albuterol-ipratropium, aspirin and IV fluids. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
34 2021-04-24 numbness Systemic: Lymph Node Swelling-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe,... Read more
Systemic: Lymph Node Swelling-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Knot at injection site. Left arm, middle pinky numb & loss of sensation for top knukle (inch from top knuckle to finger tip). Sensation has still not returned. Contemplating seeking medical attention.
34 2021-04-24 pain in extremity, feeling hot For over 2 weeks: Knuckle pain, trigger finger like symptoms, knee pain, knee radiating heat, tendon... Read more
For over 2 weeks: Knuckle pain, trigger finger like symptoms, knee pain, knee radiating heat, tendon pain in knee
34 2021-04-25 flushing Day 2 post vaccine, I experienced severe chills throughout the day. Onset upon waking up. I felt l... Read more
Day 2 post vaccine, I experienced severe chills throughout the day. Onset upon waking up. I felt like I could not get warm at all, and flu-like symptoms up until around 4pm day 2. Then it turned to a fever and felt very flushed. I was irritable and lack of patience. Day 3 I was back to about 95%. I did take acetaminophen to ease the day.
34 2021-04-25 tingling Left arm tingling, respiratory distress. Vitals WNL.
34 2021-04-25 tingling Tingly fingers in both hands going for about a month now
34 2021-04-26 feeling cold Headache; fatigue; body aches; cold-like symptoms; This is a spontaneous report from a contactable c... Read more
Headache; fatigue; body aches; cold-like symptoms; This is a spontaneous report from a contactable consumer. A 34-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3248) via an unspecified route of administration in right arm on 12Feb2021 15:00 as single dose and was previously administered the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3248) via an unspecified route of administration in right arm on 19Jan2021 07:30 for covid-19 immunization. Patient was 34-years-old at the time of vaccination. Vaccination facility type was workplace clinic. Patient medical history was not reported. Concomitant medication included fish oil, alprazolam and vitamins nos (DAILY MULTIVITAMIN). On 14Feb2021 at 09:00, the patient experienced headache, fatigue, body aches and cold-like symptoms. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other vaccine in four weeks. No treatment was given for the event. The outcome of the events was recovering.
34 2021-04-27 pain in extremity, night sweats Sore arm, fever (99.5-100.1 F) , muscle ache, night sweats and chills. Symptoms started about 9 hour... Read more
Sore arm, fever (99.5-100.1 F) , muscle ache, night sweats and chills. Symptoms started about 9 hours after receiving the vaccine; persisted for the next 24 hours.
34 2021-04-27 pain in extremity Cold like synptoms-post nasal drip; enlarged lymph nodes; sore throat; sore arm; general malaise; ru... Read more
Cold like synptoms-post nasal drip; enlarged lymph nodes; sore throat; sore arm; general malaise; runny nose; wheezing; This is a spontaneous report received from a contactable other health care professional (patient him-self). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL9269) via an unspecified route of administration to Left arm on 19Feb2021 12:15 at single dose for COVID-19 immunization. Patient medical history included ADHD, Anxiety, Depression, Psychosis, Ashthma and seasonal allergies. Patient concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). On 19Feb2021 15:00 patient experienced with Cold like symptoms- post nasal drip, sore throat, sore arm, enlarged lymph nodes, general malaise, runny nose and wheezing. Patient did not receive any treatment for the events. Outcome of events was not recovered.
34 2021-04-27 tingling Patient complains of puffiness/ slight tingling on fingers. Provider noticed some 'whitish patches' ... Read more
Patient complains of puffiness/ slight tingling on fingers. Provider noticed some 'whitish patches' on finger tips of right hand.
34 2021-04-28 feeling cold At approximately 6:00pm on 04/23/2021 patient during 30 minute observation had a witnessed syncopal ... Read more
At approximately 6:00pm on 04/23/2021 patient during 30 minute observation had a witnessed syncopal episode with loss of consciousness. Pt was assisted to stretcher during episode and assessed, presenting unresponsive initially, and then improved to AA&Ox4, airway patent, breathing normal and non-labored. Pulse bounding and thready with delayed perfusion. Pt skin pale, diaphoretic, and cool. Pt condition did not improve with oral hydration. EMS contacted via 911 for transport. Pt administered 300ml IV Normal Saline via 18g catheter in left AC. Vitals as follows: (1800 91P, 112/58 16R, 98%)(1808 99P,90/50, 23R, 98%)(1812 109P, 94/50, 20R, 98%)
34 2021-04-30 tingling Distal paraesthesia, pins and needles, tingling feeling throughout body.; This is a spontaneous repo... Read more
Distal paraesthesia, pins and needles, tingling feeling throughout body.; This is a spontaneous report from a contactable consumer reported for self. This 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 34 years old on 05Mar2021 04:00 PM Arm Right at single dose (Lot: EN6204) for COVID-19 immunisation. Medical history included Childhood food allergies, but years since allergic reaction. Prior to vaccination, was the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. None other medications the patient received within 2 weeks of vaccination. He experienced Distal paraesthesia, pins and needles, tingling feeling throughout body on 09Mar2021 08:00 which result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, has the patient has not been tested for COVID-19. 4mg 6 day course of Prednisone was received for the events. Outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected
34 2021-04-30 seizure like phenomena Pt received 1st dose at 345 pm at 355 pm, pt became diaphoretic and had tonic-clonic-like seizure, p... Read more
Pt received 1st dose at 345 pm at 355 pm, pt became diaphoretic and had tonic-clonic-like seizure, pt was lowered to the ground and seizure-like activity which lasted for a total of 5 -6 seconds. pt was then responsive without confusion. BP 110/70 T 96.9 O2 99% 4 L NC RR 18 HR 78 Vitals recheck at 410 BP 112/72 T 97.1 O2 100% RA RR 16 HR 74 Pt stated he had not eaten all day, he was given juice and granola bar. Pt reported feeling much improved. He was cleared to leave site at 430 and he will follow up with Urgent Care or PCP
34 2021-05-01 cold sweat Patient received his vaccine and a few minutes later felt like he was going to pass out. He said his... Read more
Patient received his vaccine and a few minutes later felt like he was going to pass out. He said his head felt foggy and just didn't fell well. He was brought back to med observation 1 by wheelchair. He looked pale and felt clammy. We laid him down on the stretcher and almost immediately felt better. He had a water when he came to us and he was given some crackers to eat. His color returned to normal and skin felt warmer. He stated that he was ready to leave. His wife was out in the car waiting for him. We took vitals at 10:12 am - heart rate 79, o2 98, BP 115/83, at 10:16 am heart rate 80, o2 99, BP 125/79, at 10:20 am heart rate 80, o2 99, BP 127/76. We released patients with other at 10:21am.
34 2021-05-02 weakness, muscle spasms Low grade fever for 3 days, sweating, nausea, severe fatigue (i slept for 20 hours yesterday which i... Read more
Low grade fever for 3 days, sweating, nausea, severe fatigue (i slept for 20 hours yesterday which is not normal for me), muscle pain throughout body (cramping pain, not a burning or stabbing pain). Got the vaccine Thursday, its Monday and I still feel absolutely drained.
34 2021-05-02 hot flush Constant Dizziness as well as Constant Body temperature changes. I get hot flashes like i'm a woman ... Read more
Constant Dizziness as well as Constant Body temperature changes. I get hot flashes like i'm a woman experiencing menopause
34 2021-05-02 pain in extremity 6 hours from vaccine === Mild injection arm pain 12 hours == Severe injection arm pain (can?t raise... Read more
6 hours from vaccine === Mild injection arm pain 12 hours == Severe injection arm pain (can?t raise beyond chest level) Chills 16 hours == High heart rate (160 bpm) 18 hours == 103 fever Severe headache Unable to sleep Exhaustion ** Took 1000 mg of Tylenol at 21 hours 24 hours == Heart rate is now only slightly elevated (120 bpm). ** Took 1000 mg of Tylenol at 25 hours 30 hours == Vomiting (x2) Heart rate is now normal 48 hours == Joint pain (shoulders and neck) Nausea subsides Temperature drops below 100 Headache is now mild 72 hours == Back to normal
34 2021-05-03 night sweats, weakness extreme tiredness; nauseated; night sweats; felt weak; light-headed; brief rapid breathing; This is ... Read more
extreme tiredness; nauseated; night sweats; felt weak; light-headed; brief rapid breathing; This is a spontaneous report from a contactable consumer reported for himself. A 34-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 16:30, at the age of 34 years, as single dose for covid-19 immunisation. Medical history included drug hypersensitivity to penicillin. The patient's concomitant medications were not reported. The vaccine was administered at the hospital. On 31Mar2021 17:00 the patient experienced extreme tiredness, nauseated, night sweats, felt weak, light-headed, brief rapid breathing all with outcome of recovering. The patient didn't receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Information on lot/batch number has been requested.
34 2021-05-03 pain in extremity 34 y.o. male with history of depression admitted to the hospital on 4/23/2021 for chest pain and leg... Read more
34 y.o. male with history of depression admitted to the hospital on 4/23/2021 for chest pain and leg pain found to be due to Deep Vein Thrombosis and bilateral Pulmonary Embolism. Patient started on heparin infusion in the hospital with stabilization of vital signs then transitioned to apixaban at DVT/PE dosing prior to discharge
34 2021-05-03 seizure Presented to ED c/o fever s/p COVID-19 vaccination onset today. Received vaccine at 12 pm today and... Read more
Presented to ED c/o fever s/p COVID-19 vaccination onset today. Received vaccine at 12 pm today and started experiencing chills around 8 pm today with continued progression in intensity. Patient received 2 doses of Benadryl PTA without relief. Patient experienced a seizure while in triage at 2135 and recorded temperature was 102.8 F. Temperature PTA 103.8. Patient had no more seizures and was treated and released.
34 2021-05-04 migraine Horrible migrainous headache; he also felt tired and fatigued; This is a spontaneous report from a c... Read more
Horrible migrainous headache; he also felt tired and fatigued; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 34-year-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Right on 11Apr2021 15:30 (Batch/Lot Number: EW0151) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE) on 21Mar2021 for covid-19 immunisation. The patient experienced horrible migrainous headache on 11Apr2021 evening with outcome of not recovered, he also felt tired and fatigued on 11Apr2021 15:30PM with outcome of recovered. Therapeutic measures were taken as a result of horrible migrainous headache. The clinical course was reported as follows: I was having some complications with my vaccine. I received my 2nd vaccination 8 days ago and hours after I got the vaccine I come down with a horrible migrainous headache. It has been 8 days now and it has not subsided. Is it common to last this long? Is it something I should be worried about? Side effects (such as fever, chills, tiredness, and headache) throughout the body were more common after the second dose of the vaccine. Consumer calling states he received the second dose of the Pfizer COVID 19 vaccine last Sunday. Reports a few hours later he had a horrible migraine headache and has had it for eight days now. Adds nothing will stop it, no matter how much Tylenol he takes. Adds he doesn't usually have headaches. Later clarifies it was pharmacy brand acetaminophen he has taken for the migraine. Provides UPS50428317112; lot S210022; expiration date AUG2023 for the acetaminophen. Consumer states he received the first dose of the Pfizer COVID 19 vaccine on 21MAR2021 at 1530PM in the right arm. Then he received the second dose on 11APR2021 at 1530PM in the right arm. By the evening after the second dose he had the headache. Adds he also felt tired and fatigued but he took a nap and that went away. Adds he figured a couple of days is okay but a week is too long and he is worried. He is asking should he be worried; how long before he should go to see a doctor? Advised caller call center does not provide medical advice. Vaccination Facility was pharmacy. No Vaccine Administered at (name) Facility. 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. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. Patient's Medical History (including any illness at time of vaccination) was none. Family History was none. Relevant test was none. No follow-up attempts are needed. No further information is expected
34 2021-05-04 unresponsive to stimuli, slurring, mild one side paralysis, severe one side paralysis Patient arrived at hospital via EMS after being found unresponsive by his parents at home. Had left ... Read more
Patient arrived at hospital via EMS after being found unresponsive by his parents at home. Had left sided paralysis in the ER, left hemineglect, right gaze, slurred speech, headache.
34 2021-05-05 unresponsive to stimuli, pain in extremity 34 y/o male with no PMHx presenting in cardiac arrest from home. Per pt's wife, he received 2nd dos... Read more
34 y/o male with no PMHx presenting in cardiac arrest from home. Per pt's wife, he received 2nd dose of the Pfizer vaccine roughly 24 hours prior. He complained of arm soreness yesterday afternoon and some chills this morning, took Tylenol for these symptoms. She found him unresponsive in bed after speaking to him roughly 2 hours earlier. Per EMS, patient was in asystole upon their arrival. He received ~ 30 minutes of prehospital ACLS and an additional 20 minutes in the ED and remained in asystole throughout.
34 2021-05-06 pain in extremity, tingling, numbness, electric shock sensation, burning sensation On the 3rd day I also woke up with left side of my face feeling a slight but noticeable cold burn ma... Read more
On the 3rd day I also woke up with left side of my face feeling a slight but noticeable cold burn mainly above my left eyebrow and left cheek bone; Arm is still sore; palms of my hands feeling as if they were on fire. The back of my neck and upper back felt like they had a really bad sunburn 8 days post vaccine; parasthesia/pins and needles in my left arm and legs; Felt lightheaded for 4 full days after the shot beginning 20 hours after the shot; facial numbness/my left arm became numb/the numbness moved to various parts of my body; Constant electrical buzz and vibration in my body for the first week which made it impossible to sleep; impossible to sleep; This is a spontaneous report from a contactable consumer (reporting for himself). A 34-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Apr2021 at 11:30 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunization. Medical history included allergy (cannot digest bananas or avocados). The patient's concomitant medications were not reported. On 17Apr2021 at 08:00, the patient felt very strong lightheaded for 4 full days, with some facial numbness, woke up with left side of his face feeling a slight but noticeable cold burn mainly above his left eyebrow and left cheek bone. After lightheadedness, his left arm became numb. The numbness moved to various parts of his body. It would leave the left arm, then move to my right arm, then it would move to my neck and throat (skin only). The patient had constant electrical buzz and vibration in my body for the first week which made it impossible to sleep. The electrical buzz in the front part of his head between his eyes. Along with the arm numbness (parasthesia), the patient woke up with palms of his hands feeling as if they were on fire. The back of his neck and upper back felt like they had a really bad sunburn on 24Apr2021 (reported as 8 days post vaccine). On an unspecified date, the patient's arm was still sore. The patient had doctor or other healthcare professional office/clinic visit. The patient also visited emergency room/department or urgent care. The patient was hospitalized for 1 day. The patient did not received treatment 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. The outcome of the event cold burn was recovering while not recovered for the other events. Information about Lot/batch number was available. Further information has been requested.
34 2021-05-06 tremor, muscle twitching EXTREME RIGORS AND SHAKING. I AM PHYSICIAN AND SUFFERED FOR 48HOURS OF SHAKING TWITCHING AND RIGORS.... Read more
EXTREME RIGORS AND SHAKING. I AM PHYSICIAN AND SUFFERED FOR 48HOURS OF SHAKING TWITCHING AND RIGORS. CHILLS AND FEVERS >103 48HOURS POST 2ND INJECTION
34 2021-05-07 pain in extremity Within 30 seconds of vaccination patient said he could feel it in his arm. started to feel light he... Read more
Within 30 seconds of vaccination patient said he could feel it in his arm. started to feel light headed, began sweating. after 5 to 10 minutes patient continued to have light headedness and experienced a black out that lasted 2 seconds. Emergency services were alerted. Emergency checked out pt and cleared him to leave. Contacted pt in the morning they said overnight they experienced itching, swelling, and redness near injection site relieved by benadryl, also experiencing a sore arm.
34 2021-05-09 seizure, seizure like phenomena 34 y/o male with no known medical history, who presents with seizure like activity lasting 2-3 secon... Read more
34 y/o male with no known medical history, who presents with seizure like activity lasting 2-3 seconds post vaccination. Patient states that this is his second vaccination in the two-dose series. Patient denies previous reaction with the first vaccination. Patient states that he fears needles. Patient was witnessed with upper arm stiffening, convulsions and syncope lasting 2-3 seconds. RNs lowered patient to the ground with legs elevated. Patient regained consciousness within seconds. Patient was not post ictal. Patient denies headache, sore throat, difficulty breathing or itch. Patient vitals (151/79 BP, 98% O2, 74 HR, 14 Resp, Glucose 125, EKG NSR). Fire rescue was called. Patient was placed in wheelchair and taken to private area where he was further assessed by the Paramedics, NP and RN. Patient was noted to be diaphoretic. Water provided and patient placed in Trendelenburg position. Fire rescue arrived. Patient refused to be transported to the ER, although it was advised by the NP. Fire rescue did not have the patient sign out AMA. AMA form provided and signed, witnessed by the NP. Patient aware of risk involved with no seeking further medical evaluation, such as worsening adverse reaction, subsequent seizures, cardiac event, MVA and/or death. Patient verbalized understanding. Patient ambulated to his car without difficulty.
34 2021-05-10 numbness pain and numbness in right paracervical muscle
34 2021-05-10 migraine Fever of 102.5 severe migraine sweating body aches Nausea blurred vision
34 2021-05-11 burning sensation, pain in extremity 3 days after I got the 1st dose I started to muscle tightness in both of my upper legs, and buttox. ... Read more
3 days after I got the 1st dose I started to muscle tightness in both of my upper legs, and buttox. I took a muscle relaxer 10 mg cyclobenzaprine once a day to try and relieve the tightness and pain but did not seem to make any difference. I drive a work truck for a living and I could not even bare to sit down anymore. The pain in my legs got to be so bad that I could not work anymore. On 5-1-2021 both of my upper legs, hips and low back where all "on fire", extremely painful to walk, could not sit down at all. Both buttox muscles hurt extremely bad when I sat down. Everything was hot to the touch and just had pulsating pain. 10 days after icing and taking ibprohen, the pulsating pain finally stopped in everything except for my left hip and low back. (But I have had chronic left hip pain and low back pain for awhile bow so that's just "normal" for me). Another symptom that has started is upper right abdominal cramping and feeling nauseous. Especially when getting up to quickly. I am very nervous about getting my 2nd dose of the Pfizer shot. Which is scheduled for tomorrow in fact.
34 2021-05-11 numbness Woke up with abdominal pain on the right side just below the ribs. I have had two other "events" tha... Read more
Woke up with abdominal pain on the right side just below the ribs. I have had two other "events" that I assumed were gallbladder attacks but the pain subsided within a few hours. With this event, after a few hours and the pain was still high, I had to be driven to the ER. Just before leaving my house I started getting tunnel vision and my arms and legs went numb. I was able to walk on my own again once reaching the hospital. As of today, 5 days later, I am still in pain. I have taken out all fatty foods and things that are bad for gallbladder issues and still no change.
34 2021-05-11 pain in extremity flu like symptoms including sore arm, chills, headache, body aches, nausea
34 2021-05-13 muscle spasms, nerve pain Severe intermittent muscle spasm and nerve pain, ongoing for 1 month after second dose
34 2021-05-13 seizure PATIENT HAD A SEVERE REACTION TO FIRST COVID-19 VACCINE, PT WAS TAKEN BY ABULANCE TO ER. HE STATED T... Read more
PATIENT HAD A SEVERE REACTION TO FIRST COVID-19 VACCINE, PT WAS TAKEN BY ABULANCE TO ER. HE STATED THAT HE TALKED TO HIS PHYSICIAN AND THAT IS WAS LIKELY NERVES/ANXIETY, HE WAS GIVEN XANAX OR ATIVAN AND TOLD TO TAKE PRIOR TO VACCINE #2. WE WERE PREPARED AS WE ARE THE SAME STAFF THAT WAS HERE WHEN HE HAD HIS FIRST REACTION. AFTER VACCINE 2 HE SEEMED OK BUT THE RPH STAYED WITH HIM INCASE OF REACTION. HE GOT PALE, SWEATY, SEEMED OK. HE THEN WENT UNCONSCIOUS, 911 WAS CALLED, HE SEEMED TO CONVULSE, AND BIT HIS CHEEK. FIRST RESPONDERS CHECKED HIM OUT, HE REFUSED TO GO TO THE ER VIA AMBULANCE. PATIENTS WIFE SAID SHE WOULD DRIVE HIM TO URGRNT CARE. 5/14/21
34 2021-05-15 bell's palsy Bells Palsy 2 days after second dose of Pfizer vaccine
34 2021-05-15 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: After inoculation of vaccine given by Ph... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: After inoculation of vaccine given by Pharmacy Technician patient fainted briefly under 10 seconds while seated in chair. Immunizer asked if patient had any issues with immunizations, patient said he does not like needles. We kept him for more than 30 minutes in the store. Patient was given water and gatorade. Patient felt okay after a few minutes and was sitting awake. Patient recovered well and left feeling well after being monitored. Note was made in profile.
34 2021-05-17 tingling, flushing Within 15 min of vaccine face flushed, felt a little light headed, and felt tingling in jaw/mouth/th... Read more
Within 15 min of vaccine face flushed, felt a little light headed, and felt tingling in jaw/mouth/throat. Intermittently worse and a little better. Was on way home from store and had to return. Ended up seeing doctor. Was given 2 Benadryl and told to monitor and not receive second shot.
34 2021-05-19 tingling, weakness Racing heartbeat, Diarrhea, Chest pain, Hypnic jerks, Overall weakness and tingling throughout the b... Read more
Racing heartbeat, Diarrhea, Chest pain, Hypnic jerks, Overall weakness and tingling throughout the body especially the legs
34 2021-05-19 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium
34 2021-05-24 cold sweat 5 min after administration, nausea, disorientation, stomach cramps, blood pressure drop, partial lo... Read more
5 min after administration, nausea, disorientation, stomach cramps, blood pressure drop, partial loss of hearing and sight, cold swat, on the verge of loosing consciousness. Reaction lasted for approximately 20 min, no medical help was administered. After 30 min, the symptoms subdued, 2 hours later were gone.
34 2021-05-24 unresponsive to stimuli As a clinical monitor, I was called over to assess a driver slumped over in his seat. He had just re... Read more
As a clinical monitor, I was called over to assess a driver slumped over in his seat. He had just received the second dose of the Pfizer vaccine approximately 10 minutes earlier. The passenger (his fiance) said he was acting normal until she heard him grunt and then realized that he was passed out. While attempting to lay flat, I performed a jaw thrust that yielded a stridulous inspiration but was still unresponsive. He did not have a palpable carotid pulse. Paramedics was summoned emergently. Within 30-45 seconds, he awoke but was confused and amnestic to the event. He had no physical complaints and no significant medical or allergy history. I auscultated his larynx (no stridor) and his lungs (CTA). His initial vitals: BP 90/51 HR 61 VR 16 SaO2 100% An electrocardiogram demonstrated a sinus rhythm without ischemic changes or evidence of conduction delay. His glucose was 119. Over the next 30 minutes, he was able to drink two bottles of water and some orange juice. That said, he still said he "felt off." Repeat vital signs: BP 118/62 HR 69 SaO2 100%. The medics advised him to follow up with his doctor, preferably today. His fiance agreed to drive him to an ED near their home for a more thorough evaluation. I provided her my phone number to provide to the ED for any questions. His clinical syndrome was consistent with a syncopal episode associated with orthostatic hypotension. Low suspicion for anaphylaxis.
34 2021-05-25 difficulty speaking 34 yo male is calling to report symptoms of itching, loss of appetite, change in voice, fatigue, nau... Read more
34 yo male is calling to report symptoms of itching, loss of appetite, change in voice, fatigue, nausea, headache and fever that started 24 hours after first Pfizer vaccination on 4/30/21. He reports taking Nyquil at night with minimal improvement. He reports symptoms have changed over the last two weeks and progressed to different symptoms. He did a rapid covid test last week that was negative. He did this at a travel location and did not see a provider.
34 2021-05-25 numbness, pain in extremity AFTER MY FIRST DOSE OF THE PFIZER COVID-19 VACCINE,MY LEFT ARM HURTED FOR A LIL BIT THE NEXT DAY ARO... Read more
AFTER MY FIRST DOSE OF THE PFIZER COVID-19 VACCINE,MY LEFT ARM HURTED FOR A LIL BIT THE NEXT DAY AROUND THE MORING TIME.BUT AROUND 12PM AFTERNOON 4/30/2021 MY LEFT SIDE OF MY FACE STARTED TO GET A NUMB FEELING.IT HAS BEEN FEELING LIKE THIS ALMOST A FULL MONTH NOW,AFTER TAKING MY SECOND DOSE OF THE PFIZER COVID-19 VACCINE,NOTHING HAS CHANGED.IT STILL FEELS THE SAME,I HAVE TO KEEP RUBING MY FACE BECAUSE IF I DONT IT WILL START TO GET NUMB EVERY TIME.I DONT LIKE THIS FEELING AT ALL,I GOT THE SHOTS BECAUSE I WANTED TO FEEL SAFE,AND MAKE SURE THE PEOPLE AROUND ME WAS ALSO SAFE.SO I NEED HELP NOW,I NEED SOMETHING TO HELP ME BEFORE IT GETS WORSE.
34 2021-05-26 pain in extremity pain in calves worse on left side then right; This is a spontaneous report from a contactable consum... Read more
pain in calves worse on left side then right; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0176), via an unspecified route of administration in left arm on 11May2021 13:30 (at the age of 34-year-old) at first, single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. Prior to vaccination, the patient did not have other vaccinations within four weeks prior, did not have other vaccinations on the same date. On 13May2021, the patient reported that he started with pain in calves worse on left side then right. It felt like they were sore, like he was working out. But he had just been sitting at his desk and doing nothing. Outcome of the event was not resolved. No follow-up attempts are possible. No further information is expected.
34 2021-05-26 unresponsive to stimuli Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Addit... Read more
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: pt fell from chair and landed on floor. scraped his face on the way on the floor. i ran to the patient and asked him if he is okay and checked to see if he was breathing, 911 was called, and after about 3 seconds, the patient regains conciousness and explains he has no idea how he ended up on the floor but remembers getting the vaccine and sitting. this occured about 5 minutes into the 15 minute post vaccination observation. pt states he gets sqeamish and nauseus at the thought of needles
34 2021-05-27 nerve pain PATIENT IS EXPERIENCING LEFT ARM NERVE PAIN
34 2021-05-28 cold sweat Body aches, chills, cold sweats, eyes burn.; Body aches, chills, cold sweats, eyes burn.; Body aches... Read more
Body aches, chills, cold sweats, eyes burn.; Body aches, chills, cold sweats, eyes burn.; Body aches, chills, cold sweats, eyes burn.; Body aches, chills, cold sweats, eyes burn.; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 13May2021 12:00 (Lot number was not reported) as single dose (at age of 34-year-old) for covid-19 immunisation. Medical history was reported as none. First dose of bnt162b2 (BNT162B2) was administered on 22Apr2021 12:00 PM in right arm (at age of 34-year-old) for covid-19 immunisation. Concomitant medication received within 2 weeks of vaccination included ibuprofen (IBUPROFEN). Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. On 13May2021 16:30 patient experienced body aches, chills, cold sweats, eyes burn. Patient had not recovered from the events at the time of the report. No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
34 2021-05-28 feeling hot I was getting ready for bed (around 2am, early night for me) and suddenly felt dizzy, nauseous, and ... Read more
I was getting ready for bed (around 2am, early night for me) and suddenly felt dizzy, nauseous, and incredibly hot. I was very stressed about it and it had been six days since the shot, so I just assumed I was either having a heart attack or a really bad panic attack. I did a meditation and chewed a couple aspirin just in case. There was extreme tightness in my chest. Breathing was difficult. The dizziness, nausea, and inability to control my body temperature went away within a couple hours and I managed to sleep. But the chest tightness and difficulty breathing persisted for about 3 or 4 days. I also noticed it hurt more whenever I was sitting upright or forward, and it hurt almost zero when I leaned back or laid down.
34 2021-05-29 feeling cold, cold sweat, tremor Client was in observation area, Ancillary, said ?client stood up and took a step and then fell to d... Read more
Client was in observation area, Ancillary, said ?client stood up and took a step and then fell to down, in one or two seconds, and his body was shaking for a second more?. Client was seated in a chair while answering questions. Client stated, ?everything went black?. Client was transferred to anti-gravity chair . RN assessed his mental orientation AAOX4 alert and oriented to place, time, location, and situation. Client denied any history of chronic illness or history of allergies. Client was found to be cool, pale and clammy . Vital Signs at 1316 110/86 HR 59 02 96%. Paramedics were called immediately. Client was transported to Hospital via ambulance.
34 2021-05-31 muscle spasms Muscle spasms for entire right arm and side, nonstop since both vaccine doses Vaccines were 2 weeks... Read more
Muscle spasms for entire right arm and side, nonstop since both vaccine doses Vaccines were 2 weeks apart 1 week after 2nd dose, visited primary care doc and received muscle relaxers. Did not stop spasms. Uses heating pad, Icy Hot, ibuprofen 3 weeks after 2nd dose, muscle spasms stopped and pain in right arm and shoulder began. Continued regime above. June 1 I went to ER for extreme shoulder pain. They ran blood and ultrasound to check for blood clots, gave morphine and muscle relaxer, and discharged. Visited primary care doc again same day and received cortisone injection in right shoulder to finally relieve pain
34 2021-05-31 nerve pain Shingles outbreak. Rash across left side of torso and chest and back. Nerve pain ongoing for a cou... Read more
Shingles outbreak. Rash across left side of torso and chest and back. Nerve pain ongoing for a couple weeks now Never had shingles before. Outbreak due to physical/mental stress factors is very unlikely.
34 2021-05-31 tremor, weakness Bruising, low energy, swollen legs, hard to breath, shaking, hard to concentrate
34 2021-06-01 electric shock sensation, speech disorder, weakness 16 hours after my second shot, I woke up with some nausea. I went to the bathroom, did not vomit, h... Read more
16 hours after my second shot, I woke up with some nausea. I went to the bathroom, did not vomit, however in the middle of urinating I collapsed on the floor, couldn't walk, couldn't form full sentences, started sweating profusely, had to crawl back to my bed, and my pulse was through the roof. I almost went to the ER, but the episode subsided within 15 minutes. When I tried to fall back asleep, it felt like I was blacking out and not drifting asleep. The next day, I experienced the typical flu like symptoms. Followed by 4 days of normalcy. On the 4th day, while working, I experienced a sharp 3 second "electric shock" feeling in my left side of my chest. On the 5th day, I already had previously scheduled an appointment with my primary for a physical. I told her about my episode; she took an EKG which yielded normal results. Lab work also looked ok. On the 6th day, I started feeling some more nausea and fatigue. On the 7th day, the vertigo intensified tenfold, and the room was spinning. That's when I started experiencing the following symptoms: ? More nausea. ? Dizzy spells that come and go, especially after eating. ? Persistent periodic electric shock feeling in my left chest. It?s dull but annoying. And just when I think it?s gone for good, another 1 second shock happens. ? Left arm is weak - the entire arm. ? When I try to sleep, the left side of my head feels as though I?m blacking out when I start drifting. It almost feels like I?m getting anesthesia or something like that. But just the left side. ? Basically the left side of my body (I got the jab in my left arm) from the waist up just feels off. ? One of my arms is numb when I wake up until I shake it out. It?s not one particular arm. ? Energy levels are low. Especially when I wake up and start moving around. On the 8th day, I went to the ER thinking perhaps it was a heart attack. Nothing - EKG was again normal and lab work was normal. The doctor told me it's all in my head - anxiety. However, I'm not anxious and I'm a very level headed individual. It's now day 12 and I feel overall awful. I can't concentrate on anything. I'm not thinking clearly and forgetting simple things. The dull feeling and electric shocks on my left side continue. I've never felt this bad before. I'm a healthy 34 year old that exercises regularly, has never smoked or done drugs, rarely drinks alcohol, and eats generally very healthy. If given a second chance I would not take the covid shot. I am praying this goes away.
34 2021-06-01 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Stomach aches-Mild, Systemic: Flushed / Sweati... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Stomach aches-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: Pt started feeling lightheaded and signs of flushing at 3:05PM post-vaccination. RPh had pt lie down on the floor and continiously monitored BP and pulse. BP and pulse were 96/55; 52 and 122/74; 80 at 3:08PM and 3:17PM, respectively. Pt had no relevant PMH and attributed his lightheadness to anxiety and witnessing his partner experience vertigo post-vaccination. Pt fully recovered and left the pharmacy at 3:35PM. Pt's temp was 95.5 F at 3:24 PM.
34 2021-06-02 tingling woke today, 19May at 1 am with bad chest pain and tingling down his arm; woke today, 19May at 1 am w... Read more
woke today, 19May at 1 am with bad chest pain and tingling down his arm; woke today, 19May at 1 am with bad chest pain and tingling down his arm; pericarditis; myocarditis; He still felt off on Tuesday; then felt malaise later in the day; This is a spontaneous report from a non-contactable consumer. A 34-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date for covid-19 immunisation. Clinical course, after vaccination, patient felt fine most of 16May2021, and then felt malaise later on 16May2021, and took off from work on 17May2021. He still felt off on 18May2021 and woke on 19May2021 at 1 am with bad chest pain and tingling down his arm. He was admitted. Patient was diagnosed with myocarditis and pericarditis. His tropic level was 11. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
34 2021-06-02 tremor, weakness, flushing Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy... Read more
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Systemic: Weakness-Mild, Additional Details: few minutes after given the covid pfizer vaccine, patient felt like he was going to black out and had ringing in his ears. He was having chills and sweats. his face was becoming more pale than normal. Pt was given orange juice and a protein bar. After 911 was called, his face seemed to have gotten its color back and he did state that he did felt better than before. EMT took him away to the hospital. the patient came back few hours later, and he stated that he felt better and is doing okay now.
34 2021-06-03 weakness Can not seem to gain any energy back.; Headaches; Severe exhaustion for 3 days after plus heightened... Read more
Can not seem to gain any energy back.; Headaches; Severe exhaustion for 3 days after plus heightened previously existing conditions; Loose stool; This is a spontaneous report from a contactable other health care professional. A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 09Mar2021 at 12:45 (at the age of 34-years-old) as a single dose for COVID-19 Immunisation. The patient medical history included gout, chronic depression, HF (high functioning) anxiety and BPD 2 (borderline personality disorder). The patient concomitant medications included colchicine (MANUFACTURER UNKNOWN). 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. On 09Mar2021 at 15:30, the patient experienced loose stools, headaches, exhaustion for 3 days plus heightened previously existing conditions. After 7 days, severe exhaustion and heightened conditions continues, coming in waves. It was also reported that the patient could not seem to gain any energy back. The patient did not receive treatment for adverse events. The clinical outcome of the loose stools, headaches, exhaustion, condition aggravated and loss of energy were not recovered. No follow-up attempts are needed. No further information is expected.
34 2021-06-03 muscle spasms Fever 100 +; Extreme chills; Back ache / spasms and cramps; Overall body pain, inability to get out ... Read more
Fever 100 +; Extreme chills; Back ache / spasms and cramps; Overall body pain, inability to get out of bed; Lightheadedness, brain fog; Back ache / spasms and cramps; Back ache / spasms and cramps; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE BIONTECH; Lot number: EN6203) via an unspecified route administration in right arm on 26Feb2021 at 10:00 (at the age of 34-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH; Lot number: EN6206) via an unspecified route in left arm on 16Mar2021 at 8:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16March2021 at 14:00, the patient had experienced fever (more than 100), extreme chills, back ache, spasms and cramps, overall, his body was in pain, inability to get out of bed, lightheadedness, brain fog. He was not comfortable to drive for 24 hours after the vaccination with the first dose. It was reported that, the patient had similar experience after first shot, but lesser effects. The office recommended the patient to take the following day off from work because so many people had experienced intense adverse events after second dose. The patient did not receive any treatment for the events. The clinical outcome of the events fever (more than 100), extreme chills, back ache, spasms and cramps, overall body pain, inability to get out of bed, lightheadedness, brain fog was recovering. No follow-up attempts are needed. No further information is expected.
34 2021-06-03 tremor Coming close to 6 weeks with vertigo issues , I?m off balance , unsteady, shaky movement, I haven?t... Read more
Coming close to 6 weeks with vertigo issues , I?m off balance , unsteady, shaky movement, I haven?t had any progress of feeling better! I have anxiety and panic attacks, I have the chills in the morning. I?ve seen my PCP who prescribed me mcylzine , and a steroid taper pack ! Didnt really see and or feel any change ! So she referred me to an ENT , and he wants me to take nortriptyline , but I?m very cautious of taking a anti depressant! These events have brought great fear to me! I was perfectly normal before the vaccine! I would run everyday , workout and enjoy life! I haven?t been able to enjoy these things! Currently taking hydroxyzine for anxiety and high vitamin to get the inflammation done! Must be a inner ear inflammation from the spike protein we think! I cry a lot , cuz I miss my life
34 2021-06-06 weakness Fever, ache in all joints, loss of energy, dry mouth,
34 2021-06-06 facial paralysis, slurring Emblematic stroke in vision and language centers of brain causing blurred vision and aura as well as... Read more
Emblematic stroke in vision and language centers of brain causing blurred vision and aura as well as facial droop and slurred speach.
34 2021-06-06 numbness, tingling, pain in extremity 1stApril: Patient Reports: Arm pain [Onset: 2 Day(s) Acute; Char.: Denies Swelling, Trauma, Arthriti... Read more
1stApril: Patient Reports: Arm pain [Onset: 2 Day(s) Acute; Char.: Denies Swelling, Trauma, Arthritis Reports Ache; Location: Reports Left arm; Pattern: Reports Constant, Worse with lifting, Worse with movement; Free text: Patient presents with left arm pain and numbness since yesterday morning. Patient describes the pain as a 7/10 aching pain that is worse with extension of the shoulder and shoots down to the hand with associated numbness and tingling. He denies any weakness or loss of sensation. Patient denies any leg, neck, or facial involvement. No facial droop or impaired speech. No cardiovascular history. Patient denies any known injury to the area or history of similar symptoms but states that he received the 1st dose of thePfizer vaccine in the left arm on Friday. Patient has been using diclofenac at home without relief. He denies any erythema, swelling, itching, or rashes in the area]; Arm numbness [Onset: 1 Day(s); Char.: Reports Ache; Assoc. Sx: Denies Chest Pain, Grip weakness, Neck pain, Speech impairment, Tingling, hands, Chest pressure, Leg weakness, Chest tightness]. Patient Denies: Grip weakness; Neck pain; Speech impairment; Leg weakness; Chest tightness. 5 April: Pain has receded and arm can be moved again.
34 2021-06-07 weakness, discomfort, tremor, pain in extremity, seizure convulsions; he was not conscious/Blacked out/pass out; Tunnel vision; shaking; sweating profusely; ... Read more
convulsions; he was not conscious/Blacked out/pass out; Tunnel vision; shaking; sweating profusely; Lightheadedness/Dizziness; sore arm; He turned ghostly white; tired; weak; feeling like he was going to black out/going to pass out; could not elevate his feet; couldn't get comfortable; restless; This is a spontaneous report from a contactable consumer (patient). A 34-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in Arm Left on 17May2021 (at the age of 34-years-old) (Lot Number: EW0187) as single dose for covid-19 immunization. Medical history included higher than normal blood pressure, about 2-3 weeks ago, his blood pressure was very high due to really crazy stress in his life and eating terrible; headaches, smoked marijuana, drunk vodka, sometimes he had a sensitivity to needles, sometimes he will have angst or nervousness with needles, Sometimes he got a little queasy with the sight of needles and just had a ton of dental work done. Concomitant medications included cetirizine hydrochloride (Generic Brand Zyrtec); caffeine, paracetamol (EXCEDRIN) taken for headaches. He explained he took Generic Brand Zyrtec which he had been on for years now and he took Excedrin for headaches when he got them. Those were basically the only medications he took really. He hadn't had any type of vaccine. He previously had a tetanus shot about 10 years ago for Immunization. There was no previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. There were no vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient received his first dose of the Pfizer BioNTech COVID 19 Vaccine on Monday, 17May2021. Within 3-5 minutes of getting the vaccine, he had a really crazy reaction. He remembered looking at his wife and she told him he was having mild convulsions as he was sitting in the chair in May2021. He was kind of shaking in May2021. He turned ghostly white and he began sweating profusely in May2021. He mentioned that her wife said that he was not conscious for around 5 minutes and was "snoring with eyes open" in May2021. He added that he was "fighting to stay awake" for around 15-20 minutes after that. He blacked out. All he remembers was that he was trying to fight off tunnel vision for a very brief time in May2021. The pharmacist continuously checked on him. The lightheadedness and feeling like he was going to black out lasted 15-20 minutes in May2021. They put him in a chair and told him to elevate his feet, but the caller explains he could not elevate his feet. He had his feet in another chair in front of him. He couldn't get comfortable, he was sitting down. He was restless, lightheaded. He kept feeling like he was going to pass out. So, then he tried to stand up and walk a little bit. He only made it 5 steps. So, he sat on the ground and laid down. He laid on the ground, flat on his back, and put his feet in a chair, which was about 2.5 feet above him for about 15-20 minutes. He started to feel better. He still felt very tired and weak in May2021 but he was able to stand up and walk and go home. He hadn't had a reaction since. He had had no other symptoms besides just a sore arm in May2021. He confirmed he recovered completely from his experience when he was administered the vaccine. He came home from the vaccine facility, laid on the couch and watched TV for a couple of hours and then fell asleep for 3-4 hours. He was tired, but he felt completely fine. He had no lightheadedness, no dizziness. He also wanted to add sometimes he has a sensitivity to needles, but he didn't when he received the COVID vaccine. Sometimes he will have angst or nervousness with needles, but he was actually excited to get the COVID shot. He was even comforting his wife and was telling her everything is going to be okay. He wasn't worried about the needle with the COVID shot. Sometimes, he gets a little queasy with the sight of needles, but he saw the needle and he didn't feel faint or angst when getting the shot. He just had a ton of dental work done, where he had huge needles shoved in his mouth and he didn't feel faint or anything. He really wanted to get the second shot to finish the vaccination series. He did kind of believe he had a reaction, he was not trying to play it off and say "oh I got the vaccine and passed out". He knew himself and knew what it's like to faint and this experience just felt different. He believed he had a reaction. He never felt tunnel vision that strong in his entire life, it felt like being punched in the face. Since those 2-3 weeks, his stress load had gone down and he had had a drastic change in his diet, so his blood pressure was reading much better now. This past Monday, 17May2021, when he received his vaccine, his blood pressure shouldn't have been that high. The EMT's did come before he left and because he passed out his blood pressure was low at 100/60. When providing the Lot number off of his vaccine record card, the patient explained the last digit was either a 7 or a 2, he can't read this person's handwriting", however, he eventually confirmed the number was a 7. The events did not require a visit to Emergency Room and Physician Office. The outcome of event tired was unknown and the outcome of the other events was recovered in May2021.
34 2021-06-08 discomfort After receiving my second COVID-19 vaccine, I began feeling feverish and achy about 20 hours after t... Read more
After receiving my second COVID-19 vaccine, I began feeling feverish and achy about 20 hours after the shot. I left work early to come home and rest. About 34 hours after the shot, I woke up around 2:00 am with intense abdominal and back pain, a fever, and vomiting. I took Tylenol and tried to rest, but my discomfort continued throughout the day. By the afternoon of March 30, I began to worry that I was having more than a typical vaccine reaction. The PA who saw me assessed my symptoms, performed an abdominal exam, and then dismissed my issues as a bad vaccine reaction. He gave me an injection of toradol and sent me home. My symptoms subsided after the toradol injection, but I still felt unwell. On March 31, I had a previously scheduled visit with my primary care doctor. During the visit, I described my symptoms after receiving the vaccine, but I was told again that I was just having a really bad reaction to the vaccine. Throughout that day, my condition continued to worsen, and by the evening of the 31st I developed a fever and my abdominal pain returned. I scheduled an emergency telemedicine visit. I described my symptoms and described the pain I was feeling, but again, I was told I was having a bad vaccine reaction. On the morning of April 1, I woke up with a fever and debilitating abdominal pain. I drove myself to the ER where I was diagnosed appendicitis. My appendix was about to rupture, so I was rushed into surgery. I was released after several days but had to return.
34 2021-06-09 burning sensation Neck lyph nodes swelling, under chin to collarbones, pancreatitis, never had prior occurance. Felt l... Read more
Neck lyph nodes swelling, under chin to collarbones, pancreatitis, never had prior occurance. Felt like liver was on fire, similar to gallbladder pain. I do not have a gallbladder, fatique
34 2021-06-13 weakness Patient c/o pain in left arm where he received the vaccine. Pain noted more when he goes to the gym... Read more
Patient c/o pain in left arm where he received the vaccine. Pain noted more when he goes to the gym and lift weights. Stamina has decreased, elevated heart rate with weight loss or 2-3 lbs. Seen by a Nurse Practitioner and given Benadryl for sleep and he received prednisone. was dx with dehydration also. Referred to Urgent care for follow up. States he had a lack of sense of smell and digestive issues.. Weakness noted with insomnia. Advised to get COVID 19 test to rule out virus. He did get a covid test done on 6/3/2021 and it was negative. On 6/7/2021 his heart rate and weakness decreased. He will follow up with a physician as directed.
34 2021-06-14 weakness, pain in extremity Later Sunday June 13th arm was sore and was very tired. In the middle of the night of Sunday/ early ... Read more
Later Sunday June 13th arm was sore and was very tired. In the middle of the night of Sunday/ early Monday morning he woke up feeling horrible. Dizzy, nauseated, body hurt, sweating then the chills. No fever. All Monday he slept on and off waking up feeling nauseous, weak, dizzy, having chills to sweating. Monday evening started throwing up fluids. Has had no appetite. Tried to eat a piece of bread, threw it up.
34 2021-06-14 pain in extremity Persistent arm pain (ongoing as of this date), pressure in head/ears especially at nights.
34 2021-06-16 feeling hot Pt became hot, diaphoretic and felt chest pain within minutes of receiving dose. Pt was layed down, ... Read more
Pt became hot, diaphoretic and felt chest pain within minutes of receiving dose. Pt was layed down, ice packs applied and was given juice. Within minutes, symptoms resolved per patient.
34 2021-06-16 tingling, burning sensation sleeplessness; tingling burning in arms at night; tingling burning in arms at night.; This is a spon... Read more
sleeplessness; tingling burning in arms at night; tingling burning in arms at night.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6205) via an unspecified route of administration in the left arm on 27Feb2021 at 12:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Patient Medical history include COVID-19 infection around mid Feb. The patient had not been tested for COVID-19 since the vaccination. The patients concomitant medications included pantaprozole (MANUFACTURER UNKNOWN), rosuvastatin (CRESTOR), simethicone (PHAZYME) and finasteride (MANUFACTURER UNKNOWN) all for unknown indications from unknown dates. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 14Mar2021, at 03:00 after 2 weeks of vaccination patient experienced sleeplessness and tingling burning in arms. The patient did not receive any treatment for sleeplessness and tingling burning in arms. The clinical outcome of sleeplessness and tingling burning in arms was not resolved. No follow-up attempts are needed. No further information is expected.
34 2021-06-17 cold sweat anaphylactic reaction; about to black out/lost consciousness; cold sweats; had a hard time /trouble ... Read more
anaphylactic reaction; about to black out/lost consciousness; cold sweats; had a hard time /trouble swallowing; turning pale; his pupils were dilated; This is a spontaneous report from a contactable Pharmacist via Medical Information. This Pharmacist reported for two patients, this is the first of two reports regards to a male patient. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in left arm on 02Jun2021 between 10:00 and 11:00 am, maybe around 10:30ish (Batch/Lot Number: EW0178; Expiration Date: Aug2021, NDC number: 59267100002) as 1ST DOSE 0.3ML, SINGLE for covid-19 immunisation at pharmacy. The patient medical history and concomitant medications were not reported. No prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. A pharmacist from pharmacy had 2 patients who received the vaccine and both had a reaction after the dose, within one hour after receiving the dose, and EMS was called. The pharmacist confirmed the first patient had the reaction within 1 hour of receiving the dose. She clarified this person was having cold sweats, about to black out, had a hard time and trouble swallowing and was turning pale, his pupils were dilated. Pharmacist explained they make them sit there for 15 minutes after receiving the vaccine so this reaction happened maybe 3 minutes after he got the shot. The EMS came and he was brought to the hospital. The patient did come back afterwards and he said the doctor didn't know 100 percent what happened, but it might been a slight allergic reaction, not to the point where he lost consciousness, but they did release him. She clarified they checked his vitals and everything and released him. When pharmacist was probed for the event, the pharmacist thought it was an anaphylactic reaction. The events require a visit to Emergency Room, patient was brought by EMS. Not had a visit to Physician Office. Unknown if patient received treatment, the pharmacist wasn't be told that much information. The outcome of events was unknown. Causality: In this case, pharmacist did not think so. She thinks maybe it was anxiety but she wouldn't know.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events and the 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.,Linked Report(s) : US-PFIZER INC-2021646208 same reporter, product, different patient and similar events.
34 2021-06-21 muscle spasms Approximately an hour and half after patient received his 2nd covid vaccine, pt contacted pharmacy a... Read more
Approximately an hour and half after patient received his 2nd covid vaccine, pt contacted pharmacy asking if lower back pain and muscle spasms was a common side effect from the vaccine. He reported having lunch with his friends but could not stand and needed help walking to his car, could not walk on his own. I asked if he has any history of back pain or a similar situation and he denied any previous experience similar to this. I advised patient to contact his doctor as soon as possible for observation.
34 2021-06-21 pain in extremity, flushing fatigue, arm soreness, extreme dizziness, nausea, flushing. Recurred after 2 weeks. Brain fog that l... Read more
fatigue, arm soreness, extreme dizziness, nausea, flushing. Recurred after 2 weeks. Brain fog that lasted weeks.
34 2021-06-22 numbness Numbness of hand and arm where received the shot (left).
34 2021-06-22 pain in extremity, tremor, numbness and pain in extremities Right arm soreness, sweating, itching, visual & auditory hallucinations, tremors, paranoid, tachycar... Read more
Right arm soreness, sweating, itching, visual & auditory hallucinations, tremors, paranoid, tachycardia, neuropathy of right side then left side, vomiting & diarrhea.
34 2021-06-24 numbness, weakness, pain in extremity Excessive heart beating; Nausea; overall weakness; numbness of left arm; soreness of left arm; This ... Read more
Excessive heart beating; Nausea; overall weakness; numbness of left arm; soreness of left arm; This is a spontaneous report from a contactable consumer, the patient. A 34-year old, male patient received his unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 15Mar2021 at 14:30 hours as single dose, for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to vaccination patient was not tested positive for COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient has no known Allergies to medications, food, or other products. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 14:30 the patient experienced events, Excessive heart beating, nausea after food consumption - haven't been able to hold food as of morning 3/19, overall weakness, numbness and soreness of left arm during first 2 days since the vaccination. The patient didn't receive any treatment for the events. The clinical outcome for the events Excessive heart beating, nausea, overall weakness, numbness and soreness of left arm was recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
34 2021-06-24 muscle spasms bad muscle spasms/chills and soreness; bad muscle spasms/chills and soreness; bad muscle spasms/chil... Read more
bad muscle spasms/chills and soreness; bad muscle spasms/chills and soreness; bad muscle spasms/chills and soreness; Shortly after felt nauseous and had episodes of vomiting; Shortly after felt nauseous and had episodes of vomiting; Took temperature and had a mild fever at 100.4f.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3247, Expiration date was not reported), via an unspecified route of administration, administered in right arm on 04Feb2021 16:00 (age at the vaccination 34-year-old) as second dose single for covid-19 immunisation. Medical history included intestinal disorder (unknown gastric intestinal illness that is still be diagnosed). Concomitant medications included dexlansoprazole (DEXILANT) and vitamin d2. Historical vaccine included first dose of BNT162B2 (Lot number: EL3247), via an unspecified route of administration, administered in right arm on 14Jan2021 04:00 PM for COVID-19 immunization. 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. Patient felt fine after the injection and had no issues when patient went to sleep at 0600hrs. Woke up at the indicated time below to bad muscle spasms/chills and soreness. Shortly after felt nauseous and had episodes of vomiting. Took temperature and had a mild fever at 100.4 f on 05Feb2021 09:30. Patient Took a Goody's powder for fever and soreness. Symptoms have improved but nausea still persist. The outcome of the event nauseous was not recovered while for other events was recovering.
34 2021-06-24 numbness and pain in extremities, pain in extremity First shot gave Severe Edema in the feet and ankles. Went to ER to check it. Second one occurred th... Read more
First shot gave Severe Edema in the feet and ankles. Went to ER to check it. Second one occurred the same night of the vaccine which is also reported at this but that was on 5/21/21. That gave similar effects to the first one. Following after which legs started to hurt and gave pitting edema. This is not related to high sugars as it happened instantly verses long period of time. Then arms and hands began to get neuropathy as well, continuing to the present.
34 2021-06-24 numbness and pain in extremities First one couple days later gave edema in feet and ankles Second caused Edema and Neuropathy. Follow... Read more
First one couple days later gave edema in feet and ankles Second caused Edema and Neuropathy. Following immediately that evening and worsening each day and still going on.
34 2021-06-24 pain in extremity Pain in his whole mainly in his mouth and toes. Staring to get a lot of mild sores that wont heal, a... Read more
Pain in his whole mainly in his mouth and toes. Staring to get a lot of mild sores that wont heal, always coughing, lost 20lbs. Having extreme pain in throat and mouth.
34 2021-06-26 numbness, tingling Experienced foot drop. I was sitting, then stood up and tried to turn right. Lost motion in my right... Read more
Experienced foot drop. I was sitting, then stood up and tried to turn right. Lost motion in my right foot when trying to turn to walk away. After that, had tingling sensation in both arms and tongue for 10 - 15 minutes. Since the initial event, I have had a tingling/numbness sensation below my knee on my right leg, on the outside of my leg extending down to my toes and on the top of my foot. The inside of my leg feels fine so does the bottom of my foot. I can move my foot from side to side and point my foot and toes down, but I have weakness and lack of mobility when pointing my foot and toes upwards. When trying to stand on toes my right foot buckles. Can't walk on my right heel.
34 2021-06-26 migraine Hearing loss (right ear) Non stop Loud Ringing in ear (right ear) Migraine due to ear pain. Pain i... Read more
Hearing loss (right ear) Non stop Loud Ringing in ear (right ear) Migraine due to ear pain. Pain in left chest when breathing.
34 2021-06-27 tingling fainted, low bp, sob, tingling sensation on hands and feet
34 2021-06-28 flushing, weakness, tremor, unresponsive to stimuli Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Pt fainted about 4 minutes after receiving the first covid vaccine, pt was warm, sweating. He was light headed and dizzy for about 10 minutes, his girl friend came to pick him up.
34 2021-06-29 migraine recurrent horrible migraine headache; This is a spontaneous report from a contactable other healthca... Read more
recurrent horrible migraine headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6199), via an unspecified route of administration in the right arm on 12Mar2021 at 10:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. It was reported that, the patient not had migraine in past 6 months and also not had two in a row before this time. The patient did not have any allergies to medications, food or other products. 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 were not reported. On 14Mar2021 at 13:00 (two days after receiving the vaccine), the patient experienced horrible migraine headache that effected vision and had vomiting all night long. After getting better, the patient had another episode of migraine and spent night throwing up. Therapeutic measures were taken and included treatment with migraine medications (unspecified). The clinical outcome of the event recurrent migraine headache was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
34 2021-06-30 weakness I started having severe allergies and they have not stopped as of today 21Jun2021; severe sinusitis;... Read more
I started having severe allergies and they have not stopped as of today 21Jun2021; severe sinusitis; It began as a sore throat; developed into a chronic cough; sneezing; occasional weakness; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EL3247), at the age of 34 years old, in left arm on 20Apr2021 17:00 at single dose for covid-19 immunisation. Medical history was none. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took aspartame and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL3247), at the age of 34 years old, in left arm on 30Mar2021 09:30 at single dose for covid-19 immunisation. On 01May2021 07:00, within 2 weeks of the second vaccine, the patient started having severe allergies and they had not stopped as of 21Jun2021. It began as a sore throat and developed into a chronic cough. Within a few weeks the patient was also experiencing severe sinusitis and sneezing. The patient also experienced occasional weakness. All symptoms had been somewhat managed through doctor provided and over-the-counter (OTC) medication. The patient had never had to deal with seasonal or other allergies before. The patient had been tested for covid-19 since the vaccination. The patient underwent lab tests and procedures which included SARS-COV-2 RNA, QL, RT, PCR (covid-19) test (nasal swab) negative on 11May2021. Therapeutic measures were taken as a result of the event severe allergies and included treatment with prescription medication. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.
34 2021-06-30 feeling cold In about 12-14 hours after the 2nd dose of the Pfizer/BioNTech vaccine developed sever fever, chills... Read more
In about 12-14 hours after the 2nd dose of the Pfizer/BioNTech vaccine developed sever fever, chills, violent shivering. In about 24-26 hours after the vaccination chest pain/discomfort/pressure started, predominantly on the left side, and continued on and off with moderate severity until the end of June, the pain started to subside as of Jul 1, 2021.
34 2021-06-30 grand mal seizure After the administration of the vaccine, while waiting for the observation time, I lost consciousnes... Read more
After the administration of the vaccine, while waiting for the observation time, I lost consciousness for more than two minutes, I completely fainted and all my muscles contracted until they were rigid. From the symptoms the doctor said it was a tonic-clonic seizure, and that it was a side effect of the vaccine. They told me I turned purple, stopped breathing, and exhaled the remaining air until I stopped breathing for about 30 seconds until then I came back to my senses. The firefighters examined me and all my vital signs were fine so they recommended that I go home and rest.
34 2021-07-05 pain in extremity 1) There were no side effects after taking the first vaccine (except for pain on the left arm for 2 ... Read more
1) There were no side effects after taking the first vaccine (except for pain on the left arm for 2 days) 2) Until yesterday, there were no side effects after taking the second vaccine (except for pain on the left arm for 2-3 days) 3) Last night when I went to bed, I felt distinct pulling sensation of nerve on right side of the chin/jaw area. The pulling sensation is still present after 20 hours and can clearly be seen when I look at the mirror. I am not sure if this is early symptom of Bell's Palsy. 4) As of now, I do not seem to have any other side effects.
34 2021-07-05 tingling Symptoms of generalized ascending paresthesias with right hand weakness since May 18, 2021, first ... Read more
Symptoms of generalized ascending paresthesias with right hand weakness since May 18, 2021, first right foot then left, then ascending to the trunk and upper extremities. As of June 21 left with residual right hand weakness and paresthesias. second Covid Pfizer vaccine given May 19, 2021
34 2021-07-06 pain in extremity, burning sensation, numbness rhythm of the beat of the heart changes; Giving me medications for the heart anti-inflammatories rig... Read more
rhythm of the beat of the heart changes; Giving me medications for the heart anti-inflammatories right now; Neurological problems; Heart has been abnormal with rapid beating; Some arm pain and then numbness; Some arm pain and then numbness; Burning in my body; This is a spontaneous report received from a contactable consumer. A 34-year-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN0158), via intramuscular, administered in Arm Right on 07Apr2021 (at the age of 34-year-old) as dose 2, single for covid-19 immunisation. Medical history included tobacco user, I was also smoking a lot of marijuana prior. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6208), via unspecified route of administration on 17Mar2021 (at the age of 34-year-old) as dose 1, single for covid-19 immunisation. On an unknown date in 2021, the patient experienced rhythm of the beat of the heart changes, his doctor gave him medications for the heart anti-inflammatories right now, had Neurological problems, heart has been abnormal with rapid beating, some arm pain and then numbness and burning in his body. Reporter stated that "he started getting heavy symptoms a month after receiving the vaccine and it started with his heart. Caller states he has seen a few people with the same side effects that he is experiencing. Caller states he has had heart problems and neurological problems that took place since his second dose of the vaccine on 07Apr2021. Caller states his heart has been abnormal with rapid beating. Caller states he also had some arm pain and then numbness. Caller states after the first dose he received on 17Mar2021 his heart was a little weird but then it went away. Caller states after the second dose and after the first two to three days he noticed his heartbeat was a little different. Caller states he never had issues with vaccines in the past and never had heart or neurological issues before". "I went to go see my doctor and they are giving me medications for the heart anti-inflammatories right now. Yeah, they are giving me aspirin right now and also another drug called Colchicine". "I was eating a lot of junk food and then I was also smoking a lot of marijuana prior but I stopped that like a month ago because I started getting a lot of heart problems a month ago which is almost like a month after the vaccine or a few weeks after. So I didn't get the heart problems like heavy heart problems till later like weeks later and that's just not heart problems there's also like neurological problems like in my brain different sensations and numbness in my body and stinging and burning in my body and also my heart you know It could mean like a rhythm of the beat of the heart changes and stuff like that I never had any issue like that so it must have been the side effect of the vaccine you know I know not a lot of people get it but some people do so I just thought to report it you". The patient underwent lab tests and procedures which included blood test: n/a, electrocardiogram: n/a on an unknown date in 2021. Therapeutic measures taken as a result of events included aspirin and colchicine. The outcome of the events were unknown. Follow-up attempts are completed. No further information is expected.
34 2021-07-08 numbness Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-S... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Visual Changes/Disturbances-Severe
34 2021-07-08 pain in extremity pain in arm/shoulder area and still experiencing pain
34 2021-07-08 cold extremities, numbness 02/05/2021- After the 15 minute wait, I went to work and ten minutes into drive my left arm became c... Read more
02/05/2021- After the 15 minute wait, I went to work and ten minutes into drive my left arm became cold, numb, inflamed and swollen, continued for about 2 hours, was radiating toward my fingertips and shoulder. Fever 102.0 for abut 6 hours, no medication needed it subsided. I also had lethargy, body aches. Within 48 hours all side effects subsided.
34 2021-07-10 weakness Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild
34 2021-07-10 weakness Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Nausea-Mil... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild
34 2021-07-10 numbness, pain in extremity, tingling, seizure seizure; unconscious; passed out; stopped breathing; received Pfizer vaccine, first dose 3 days ago,... Read more
seizure; unconscious; passed out; stopped breathing; received Pfizer vaccine, first dose 3 days ago, technically I got pneumonia vaccine, PPsV23; lost my sense of taste; I can't smell; I am feeling like a tingling sensation in my hands, like numbness; I am feeling like a tingling sensation in my hands, like numbness; metallic taste; fatigue; coughing up phlegm; hard time getting to sleep; Left arm hurt a lot and hand is swollen; Left arm hurt a lot and hand is swollen; Tightness of Chest; I can breath but it's like I can't get any oxygen; it's like very hard for me to get air; This is a spontaneous report from a contactable consumer (patient). A 34-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EW0177) via an unspecified route of administration in Arm Left on 25Jun2021 15:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from 2019 to an unknown date doctors believe I had Covid-19 in 2019, neoplasm malignant from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The first dose of the Pfizer vaccine was on 25Jun2021, I have got this kind, out of order. So, he said from what he remembers that he was fine following the vaccination, and everything was good but he took a few steps and collapsed. He started having a seizure and he said, my mom said, you stopped breathing, I was unconscious, tightness of chest I can breathe but it's like I cannot get any oxygen it's like very hard for me to get air. He says, the doctors there, the doctors, he says don't get me started on the (sentence incomplete) and he went to the hospital and was there for like 5 hours and they gave him 5 mg of Valium treatment and he said that was it. They could not find his vein, they did an ultrasound, I guess to find his vein and apparently, he had a couple of seizures. He says, I don't recall, all I remember is waking up in a hospital and I received the Pfizer vaccine first dose and then he said, 3 days ago, technically, I got Pneumonia vaccine which he said he received the PPSV23 vaccine prior the same day of his Pfizer vaccine. Also, he says, I hate needles, so I got tortured. I had the pneumonia vaccine (PPSV23 vaccine) first, he was with his mom, they went out for a while and then went back to where he got the Pfizer vaccine following that (PPSV23 Vaccine). He said, he was there after the Pfizer vaccine for about 30 minutes, got up and had a seizure and he says, that also his mom said that he cannot remember anything because he was unconscious, and they took him to the hospital. Also, he said, he lost his sense of taste, I cannot smell, he said, he was feeling like tingling sensation in his hands like numbness and left arm hurt a lot and hand was swollen. In 2019, he says, he got sick with respiratory issues. He was not sure if he had Covid because they did not know about Covid at that time when he was in the hospital then (consumer had respiratory issues before getting the vaccine, hence not captured as event). He said, it was freaking him out and he was scared to take the second shot. He said, he does not know if this was the combination of getting two vaccination and he says, he used to have cancer (not clarified further, hence not captured as event) and then he says, that they did blood work, it was been followed by the place and they did not tell me anything about the blood work. He says, should I be considered or concerned about getting the second dose of the vaccine because I am experiencing various symptoms and what can I do about my side effects because he is still experiencing metallic taste, loss of smell, fatigue, coughing of Phlegm, having a hard time getting to sleep. Then he says, I forgot to mention, I could feel my heartbeat and I have a cough, I have had a cough from very long time when doctors believe I had Covid-19 in 2019 (further clarification unknown). He wanted to know how safe the vaccine was. Therapeutic measures were taken as a result of seizure, unconscious, passed out. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
34 2021-07-11 tremor Metallic taste 20 hours after second dose of Pfizer vaccine. Other side effects: mild fever, some so... Read more
Metallic taste 20 hours after second dose of Pfizer vaccine. Other side effects: mild fever, some sore throat, body pain. During the first night: chills to the point of shaking and insomnia.
34 2021-07-14 feeling hot, weakness, feeling cold 5 mins after receiving vaccine I felt a strong sense of heat within the muscles in my back. Soon aft... Read more
5 mins after receiving vaccine I felt a strong sense of heat within the muscles in my back. Soon after felt anxiety and scared so I ran to the front of pharmacy to get the pharmacist?s attention for them to call 911. I began feeling weak and started hyperventilating, feeling like I was going to die. Almost felt difficult to gasp for a full breath of air. As I got on the floor due to feeling weak, I began sweating profusely in my face, while at the same time, seeing my sweat drip on the ground like I just ran a full sprint mile. I was begging the pharmacist for some water but she refused to give me water because she thought I would choke. I was able to breathe but hyperventilating made it difficult. A couple mins passed, and I began to try my best to control my breathing by taking deeper breaths. I say about 5 mins, the paramedics arrived, but by then, all the side effects went away. Lastly, I felt the chills and very cold by the time the medics came. I got up on my own accord, went outside in the sun and felt normal again.
34 2021-07-15 speech disorder 24 hours after vaccination - compressed breathing, extreme shortness of breath, swollen chest and di... Read more
24 hours after vaccination - compressed breathing, extreme shortness of breath, swollen chest and difficulty speaking or catching air. Extreme headache, fatigue and continuous projectile vomiting. Also experienced irregular heartbeat and increased heart rate. Hands and feet were swollen, red, itchy, hot to touch and joints were stiffened to the point where I couldn't walk or grip. After 48 hours the fever and vomiting were omitted from the symptoms. For the last 2 weeks the chest pain, heart irregularities, swelling of hands and feet and chronic inflammation, fatigue, etc. have continued.
34 2021-07-17 seizure, weakness, muscle twitching Seizure; I just like sit down and I pass out; they also give a Pneumonia shot and on top of that the... Read more
Seizure; I just like sit down and I pass out; they also give a Pneumonia shot and on top of that they gave me the Pfizer shot on the same day; Metallic in my mouth, lost sense of smell and sense of taste; Head is twitching; My visions going blurry; My vision is going in and out; Abdominal pain; Hard to concentrate and it's been kind of really bad for me; I stopped breathing; Difficult breathing which I happened having difficulty breathing; I just fell; Weak; My arms are really weak; I am losing my hair now, like my facial hair is coming off like I barely even pull it and it just comes off; Tired like a super tired; Dizziness; Have lost like 30 pounds; Metallic in my mouth, lost sense of smell and sense of taste; Metallic in my mouth, lost sense of smell and sense of taste; I got a rash; scaling of hand and feet; his arms were really weak; like a lot of saliva bulid up; This is a spontaneous report from a contactable consumer (patient, self-reported). A 34-years-old-male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0177 and expiry date: 31Aug2021), via an unspecified route of administration, in Arm Left, on 25Jun2021 (age at vaccination: 34 years), as a single dose for COVID-19 immunization, pneumococcal polysaccharide vaccine, 23-valent via an unspecified route of administration from an unspecified date on right arm (Batch/Lot number not reported) to an unspecified date, at unspecified dose for immunization, and levetiracetam (Keppra), route of administration, start and stop date, batch/lot number and dose were not reported for seizure and he had an allergic reaction to it, he got a rash and so his doctor decided to take him off of it. The patient's medical history included alcohol withdrawal syndrome and cancer was back in 2010. Concomitant medication included chlordiazepoxide (LIBRIUM) taken for alcohol withdrawal syndrome. The patient did not take any other vaccine 4 weeks prior to COVID 19 Vaccine. The patient underwent investigation Assessment. On an unknown date the, the patient reported that he got the Pfizer shot about two days ago, his first one and the reason why he decided to get the Pfizer shot was because he believe that it was the one with the least side effects but when he got it, he got it at the clinic that he went through and they not only give hi, the Pfizer shot they also give a Pneumonia shot and on top of that they gave him the Pfizer shot on the same day and then when he got the Pfizer shot at the clinic that he was at, it was his doctor's appointment actually, he end up having a seizure and they send him to the hospital (further clarification unknown hence seriousness criteria not checked in event). But now he was having like was the weird side effects almost like he didn't know, it's just metallic in his mouth, lost sense of smell and sense of taste and 'scaling' of the hands and feet' (not clear, hence not captured as event) and there was like his head was twitching, his visions going blurry, and he was experiencing abdominal pain but weird part was that he could eat. The patient stated that he was just really like out of it, he had recently got the shot, he has been very kind of like he didn't know, like hard to concentrate and it's been kind of really bad for me. The patient stated, that he had recently lost like 30 pounds so, he was 152-156 and now he was down 130 (further clarification unknown) and then his height was 5 feet 8 inches, on good day was 5 feet 8 inches or 5 feet 7.5 inches almost, but had, because he had sclerosis (intent of history), so it could not match up his height some times and his weight was 130 (pounds). Regarding the lot number of Pneumococcal Polysaccharide PPSV23, consumer stated that he does not think they even gave him that, he does not know, he was reading, he just found a piece of paper that said an allergic reactions could occur after the vaccination 'peruses' up leave the clinic if you see signs of severe allergic reaction, hives, swelling, difficult breathing which he happened having difficulty breathing, it says heart beat which he did, dizziness, whole weakness, and at the clinic he ended up having a seizure and then they sent him to a hospital. The patient stated that he got lab test done when he was on his doctor's appointment and he also got his lab test done in hospital when he woke up there, all he knew was his mom was with him and she said he stopped breathing after he got the Pfizer, because they did the Pfizer vaccine and he waited for 15 minutes and then they had him wait for another 15 minutes and so it was like 30 minutes, and then he was like he was okay everything was good, and he just took five step, he got up and walked just five steps, that's all remember at moment he just fell. The patient stated that he went to this, he walked to the store and he came back, so he thought he was okay with having energy, but he felt weak and tired like a super tired. He didn't know, he was losing his hair now, like his facial hair was coming off like he barely even pull it and it just came off. The patient also stated that when he was at the hospital, they gave him Valium but that was only 5mg. The patient stated that he was going to die because he heard a lot of bad thing about the vaccine, it's like stroke, heart attack aneurysms, and long-term conditions. He was just really worried because usually vaccines were not approved, he was mean this vaccination was approved way to quick and being informed of like medicine and his mom was in pharmaceutical industries. The patient's arms were really weak, he have also been experiencing months ago of the Pfizer shot, I have been having like a lot of lower back like where my spinal cord was (sentence incomplete), like a lot of saliva built up and metallic taste, his vision was going in and out and he just like sit down and he pass out and he didn't know what that mean. The patient further stated he was just wanted to make sure that he was not having like a really bad reaction to it because his body was kind of not having (incomplete sentence). So, he didn't know it's like cancer that came back in his throat but all he knew that they gave him the number and asked should he go to the hospital. He wanted to go to the hospital. The patient was suggested to contact Pfizer Medical Information department for the concern. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
34 2021-07-19 bell's palsy On Friday I was dianogosed with Bell's Palsy.; On Thursday night i started showing signs of a full-b... Read more
On Friday I was dianogosed with Bell's Palsy.; On Thursday night i started showing signs of a full-blown stroke; June 22nd I started having issues with my eye. It would look like it was cloudly and I couldn't blink.; June 22nd I started having issues with my eye. It would look like it was cloudly and I couldn't blink.; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 34-years-old male patient received bnt162b2 (Pfizer covid vaccine, formulation: solution for injection, tch/Lot Number: EW0185), via an unspecified route of administration, administered in Arm Right on 11Jun2021 12:00 (at the of 34-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with covid. The patient had no allergies. Since the vaccination, the patient had not been tested for covid 19. The patient previously took BNT162B2(Pfizer covid vaccine, formulation: solution for injection, lot number=EW0168) via unspecified route of administration, administered in Arm right on 19May2021 12:00 as DOSE1, SINGLE for covid 19 immunisation. On 22Jun2021 at 19:00, the patient experienced having issues with his eye. It would look like it was cloudly and he could not blink and eye disorder. On 23Jun2021 , Wednesday, the patient experienced issue with his eye and got worse. On 24Jun2021 Thursday night, the patient started showing signs of a full-blown stroke. On 25Jun2021 Friday, patient was diagnosed with bell's palsy and on Wednesday the issue with eye got worse. The outcome of the events was not recovered. Follow-Up (09Jul2021): Follow-up attempts are completed. No further information is expected.
34 2021-07-19 numbness, throat numbness heavy head; muscle aches; Numbness aroundcheeks, face, bottom jawline; Numbness in throat; Tired; sw... Read more
heavy head; muscle aches; Numbness aroundcheeks, face, bottom jawline; Numbness in throat; Tired; swallowing was little tight; Throat area felt tight; Throat area tender; Felt dizziness; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the arm left on 01Apr2021 at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. The patient had allergies to pollen (otherwise do not know). 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 16:15 (15 min after the shot), the patient experienced dizziness; at 16:30 (30 min after the shot), the patient felt heavy head, muscle aches, numbness around cheeks, face, bottom jawline, throat, felt tired, swallowing was little tight, throat area felt tight and tender (no difficulty in breathing). 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 reported events. The clinical outcome of the events felt dizziness, heavy head and muscle aches were recovering at the time of this report; whereas for events numbness around cheeks, face, bottom jawline, numbness in throat, tired, swallowing little tight, throat area felt tight and tender were resolved on 01Apr2021 (5 to 10 and 15 minutes later after the event started). No follow-up attempts are needed; information about lot/batch number cannot be obtained.
34 2021-07-19 muscle spasms Abdominal pain; Cramp; This is a spontaneous report from a contactable consumer, the patient. A 34-y... Read more
Abdominal pain; Cramp; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955), via an unspecified route of administration in the left arm on 31Mar2021 at 10:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included pollen allergy. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247), via an unspecified route of administration in the left arm on 10Mar2021 at 10:30 (at the age of 34-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 10:00, after 24 hours of vaccination, the patient experienced abdominal pain and cramp for 3 hours. The patient did not receive any treatment for the events. 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 clinical outcome of the abdominal pain and cramp was resolved on 01Apr2021. No follow-up attempts are needed. No further information is expected.
34 2021-07-25 pain in extremity Severe muscle soreness in left calf starting on 4-14; continued for several days, leading to ultraso... Read more
Severe muscle soreness in left calf starting on 4-14; continued for several days, leading to ultrasound of the legs on 4/16. Two blood clots were found, one in the left calf, one behind the left knee.
34 2021-07-26 night sweats Severe FUO illness with temp > 103 for 4-5 weeks duration after 10 days of receipt of COVID vaccine.... Read more
Severe FUO illness with temp > 103 for 4-5 weeks duration after 10 days of receipt of COVID vaccine. had developed pharyngitis symptoms, night sweats. work up negative for other etiologies.
34 2021-07-27 feeling cold Intense chills/shivering; Feeling chilly and achy; Feeling chilly and achy; Temperature which was el... Read more
Intense chills/shivering; Feeling chilly and achy; Feeling chilly and achy; Temperature which was elevated; Mild fever; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 01Apr2021 at 13:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. The patient had no known allergies. The patient's concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 125 mcg once daily and diphenhydramine (MANUFACTURER UNKNOWN) for an unknown indications started from an unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 11Mar2021 at 13:15 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 in the morning at 03:00, the patient woke up feeling chilly and achy. The patient took his temperature which was elevated at 99.9 F. The patient spent the rest of the day with aches throughout his body and a mild fever. The highest the fever got to was 100.5 F. The patient thought, he was feeling better in the evening, but at 22:00 when the patient walked around he had intense chills/shivering. However, by the time he woke up on the next day 03Apr2021, the patient basically felt totally fine. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the events chilliness, aches, temperature elevation, fever and shivering was resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
34 2021-07-27 numbness pain spreading through his body, arm, should, elbow, it gets worse when he uses more force like when... Read more
pain spreading through his body, arm, should, elbow, it gets worse when he uses more force like when lifting.; minimum pain at inject site of Left arm; had fever blisters all over on my lower lip; I tried moving the couch and both arms went numb gave out on me; felt like I had internal fever until they showed up; as severe muscle and joint pain; as severe muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 25Jun2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. No medical history and concomitant medications were not reported. It was reported that side effects started the same day as vaccine stated it was normal at injection site went on for 2 to 3 days minimum pain at inject site of Left arm. By the 4th day till today it has gotten worse, pain spreading through his body, arm, should, elbow, it got worse when he used more force like when lifting. 2 or 3 days ago (as reported), he started experiencing internal fever, although no temperature had fever blisters all over on his lower lip. they are still there and started 3 days ago, when his joint pain got worse, felt like had internal fever until they showed up. Right now, few hours ago, tried moving the couch and both arms went numb gave out on him. It was also reported that he did not want to go to the emergency room (ER) until he spoke. He wanted to know if this was a severe reaction. The patient explained that he was experiencing severe muscle and joint pain. The outcome of the events was not resolved. Follow-up attempts are possible. Information on lot/batch number can be obtained.
34 2021-07-27 pain in extremity Injection site soreness; Full arm soreness; Generalized fatigue; This is a spontaneous report from a... Read more
Injection site soreness; Full arm soreness; Generalized fatigue; This is a spontaneous report from a contactable consumer. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 01896589) via an unspecified route of administration in the arm left on 31Mar2021 at 11:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included Arthritis in both knees and allergic to purex laundry detergent. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from unknown date for unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Mar2021 (at the age of 34-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 31Mar2021 at 15:30, the patient experienced injection site soreness, full arm soreness and generalized fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events injection site soreness, full arm soreness and generalized fatigue was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.
35 2021-01-05 weakness Headache, Myalgia, Fever, Pain at injection site; then 1/5/2021, headache, weakness, fever; resolvin... Read more
Headache, Myalgia, Fever, Pain at injection site; then 1/5/2021, headache, weakness, fever; resolving today
35 2021-01-05 numbness Headache; blurred vision; unable to read at time; Difficulty focusing; right hand numbness; This is ... Read more
Headache; blurred vision; unable to read at time; Difficulty focusing; right hand numbness; This is a spontaneous report from a contactable Nurse (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 04:15 PM, Intramuscularly at single dose (Vaccine location: Left arm) for COVID-19 immunization. Medical history was reported none. Concomitant medications were not reported. Patient did not have any allergies. Patient did not receive other vaccine in four weeks. 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 Headache, blurred vision and unable to read at time, Difficulty focusing and right hand numbness on 30Dec2020 12:00 AM. Patient did not receive any treatment. The outcome of the events was not recovered. 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. Information on the lot/ batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events headache, vision blurred, cognitive disorder, disturbance in attention and hypoaesthesia cannot be excluded as 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 2021-01-06 pain in extremity, tension headache 01/06 -Upon waking: generalized body ache, more intense left arm ache -12PM: intermittent chills wit... Read more
01/06 -Upon waking: generalized body ache, more intense left arm ache -12PM: intermittent chills without rigors -4PM: diffuse tension headache rated 1/10 -No other signs and symptoms 01/07: no change compared to 01/06.
35 2021-01-06 pain in extremity left arm into neck pain, headache, low grade fever, nausea, body aches, treated with rest 01/07/ s... Read more
left arm into neck pain, headache, low grade fever, nausea, body aches, treated with rest 01/07/ still has headache
35 2021-01-06 tremor "The next couple of days i was extremely tired, slept for several hours in a row and was not even aw... Read more
"The next couple of days i was extremely tired, slept for several hours in a row and was not even aware of it. 12/23 I started feeling light headed and shakey and couldnt get my heart rate down when attempting a light work out. I felt so bad i took the rest of the week off. 12/30 it hit me again with really bad stomach cramps, fever, light headed and shakey again. i took covid and flu tests and it was all negative. it was so bad i was in bed from new years eve at 9p till 1/1/21 4p and i missed another week of work"
35 2021-01-07 tingling, numbness @1052 pt c/o numbness and tingling in left arm and it intensified to left leg, right toes, left side... Read more
@1052 pt c/o numbness and tingling in left arm and it intensified to left leg, right toes, left side of face. @1100 c/o of same numbness in addition to heaviness from the shoulders down and a little dizzy. @1115 pt stated he felt better and stated he felt Narrative: @1052 BP 123/85,Pulse 73, Res 16, SP02 99 RA: pt c/o numbness and tingling in left arm and it intensified to left leg, right toes, left side of face @ 1100 BP 117/78, Pulse 73, Rep 16, SP02 99 RA: c/o of same numbness in addition to heaviness from the shoulders down and a little dizzy. @ 1115 BP 132/77, Pulse 68, Rep 16, SP02 98 RA. pt stated he felt better and stated he felt numbness in left arm and left leg. Offered Benadryl pt declined and stated "he was fine to leave." Pt returned to clinic @1243 BP 137/89, Pulse 71, Rep 16, SP02 98 RA: c/o same tingling but migrated to neck but reported no shortness of breath. 1250: BP 137/89, Pulse 74, Rep 16, SP02 RA: eBenadryl given and code 99 called. Pt transported ED.
35 2021-01-10 slurring Acute demyelinating encephalomyelitis; Slurring his speech; Stroke; This is a spontaneous report fro... Read more
Acute demyelinating encephalomyelitis; Slurring his speech; Stroke; This is a spontaneous report from a contactable physician. A 35-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in deltoid (unknown if right or left) on 17Dec2020 at 30 ug, single for 'Preventative'. Medical history included hypertension. There were no concomitant medications.(Physician) He is calling about the Pfizer Covid 19 vaccine. States what is going on with the patient may be associated as a side effect. The patient got the vaccine two to three weeks ago, he clarifies the patient received the vaccine on 17Dec2020 and the patient ended up acutely developing (states it is a presumptive diagnosis) Acute demyelinating encephalomyelitis, states it looks like a radiologic diagnosis. The patient is an employee at hospital. When querying seriousness states it is medically significant but could be disabling but he thinks the patient will recover. Reporter seriousness for acute demyelinating encephalomyelitis: Medically significant, Hospitalization. Patient was hospitalized on Sunday and he is still admitted at this time. Dates when patient was in hospital for acute demyelinating encephalomyelitis was from 03Jan2021 to ongoing. Caller thinks the patient was flown to (Place) yesterday. The patient's mother asked the caller if the caller thought the acute demyelinating encephalomyelitis was from the vaccine and the caller responded that he did not think it was from the vaccine. He confirms the patient is still admitted in the hospital and the patient's attending neurologist is doctor. The caller heard about the patient from doctor. When querying covid vaccine dose, the caller states the standard dose is 30 mcg. This was clarified and documented as provided. The patient has not received his second dose yet. He asks if the patient should receive the second dose. He asks a general question if a pregnant patient can be given the Pfizer covid vaccine. He heard the patient had a stroke then the CFO tried to talk to him and the patient was slurring his speech. Caller spoke to the patient's mother this morning and caller told the mother that he would try to find out what is going on with the patient. He asked that the patient get an HIV test even though he does not think the patient is at risk. Vaccination facility type was Hospital. Vaccine administered at military facility was No. None additional vaccines administered on same date of the PFIZER suspect. AE acute demyelinating encephalomyelitis require a visit to Emergency Room, not visit to physician office. Prior Vaccinations (within 4 weeks) was none. He has heard of acute demyelinating encephalomyelitis being associated with vaccines in the past and states that it is rare and usually in kids. States he saw patients that may have had acute demyelinating encephalomyelitis back in the 80s and 90s. Therapeutic measures were taken as a result of acute demyelinating encephalomyelitis (Patient will get steroids tonight pending the review of the x-ray). The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported stroke with speech slurred, and the presumptive diagnosis of acute demyelinating encephalomyelitis (looks like a radiologic diagnosis by the reporting physician), was most likely an intercurrent disease, and unlikely causally related to the first dose 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 2021-01-10 pain in extremity, weakness Myalgia, Arthralgia, lower back pain down to heels Narrative: Lower back pain down to his heels, can... Read more
Myalgia, Arthralgia, lower back pain down to heels Narrative: Lower back pain down to his heels, cannot tolerate sitting or standing still, laying down was the only thing that help, feels fatigued and weak, doesn't feel like he has his usual strength. Missed 2 days of work. No fever. Has bilateral elbow pain. Does not feel like he is sick, just feels like he needs to rest.
35 2021-01-10 pain in extremity Body aches, headache, chills, soreness in arm. Resolved in about 12 hours
35 2021-01-11 tingling, feeling hot, numbness, flushing About 2 hours after the second dose of the Pfizer vaccine I felt a warm, flushed feeling in my left ... Read more
About 2 hours after the second dose of the Pfizer vaccine I felt a warm, flushed feeling in my left foot, not unlike stepping in a bucket of warm water. The sensation lasted about 5 seconds and disappeared on its own. Since then, about once per hour I have had the same symptom, with a warm, flushed feeling in my left foot. There is no pain, slight numbness and tingling, but no loss of function or coordination. I can sense that the symptom is about to begin approximately 10 seconds before it starts, because my foot begins to feel swollen. This has occurred about 40-50 times since the injection, and has only gone down slightly in frequency over the past 72 hours, currently it is happening about once every 1.5-2 hours.
35 2021-01-12 numbness After about 20 minutes, I noticed some mild numbness in the face, similar to getting a light dose of... Read more
After about 20 minutes, I noticed some mild numbness in the face, similar to getting a light dose of Novocain at the dentist. It stated to go away, but never fully dissipated. The next morning while getting ready for work, I noticed I could not taste anything, and mouth felt a bit numb. Also had some residual facial numbness.
35 2021-01-12 night sweats Abdominal pain, diarrhea, night sweats. All disappeared on following day
35 2021-01-12 pain in extremity Headache, Myalgia, chills, swolen clavicular nodes, left arm soreness Narrative: reports headache w... Read more
Headache, Myalgia, chills, swolen clavicular nodes, left arm soreness Narrative: reports headache was severe
35 2021-01-12 pain in extremity PT sts within a few hours of second vaccine, he experienced sore arm, tiredness, body aches, and chi... Read more
PT sts within a few hours of second vaccine, he experienced sore arm, tiredness, body aches, and chills, no reactions outside of those anticipated from the vaccine literature. Next morning, Wednesday 13JAN21 woke up with new onset of sharp, right-sided chest pain. Worsens on breathing and coughing. PN is otherwise persistent, does not radiate, but changes when breathing.
35 2021-01-13 pain in extremity, tingling, mild one side paralysis ? right arm/shoulder pain, c-spine stiffness, headache, body aches. After 2nd dose same sx and naus... Read more
? right arm/shoulder pain, c-spine stiffness, headache, body aches. After 2nd dose same sx and nausea, dizzy, blurred vision and most concerned about right scapula feeling ?weak? and intermittent right arm ?paresthesia?
35 2021-01-13 tingling body muscle aches, chills, bloody nose, fatigue, fever 100.2 f, headache, ears tingling which starte... Read more
body muscle aches, chills, bloody nose, fatigue, fever 100.2 f, headache, ears tingling which started on 1/13/21 at 4 pm. Pt. states that he still has symptoms despite taking tylenol. nose stopped bleeding after ten minutes.
35 2021-01-15 pain in extremity First dose of vaccine received on 12/18/20: no adverse reaction, felt great Second dose of vaccine r... Read more
First dose of vaccine received on 12/18/20: no adverse reaction, felt great Second dose of vaccine received Thursday night, 1/7/21: no adverse reaction that night but woke up with sore L arm in the morning. So, no unusual side effect for 24h, then experienced on Friday night: headaches, chills, body ache, fatigue. Took 650 mg of acetaminophen. Same symptoms on Saturday with increase in intensity, plus mild fever in the evening at 99.6 F (instead of 97.4 F which is "my normal"), nausea, painful eye balls, sensitivity to light and noise, loss of appetite. Took 650 mg tabs of acetaminophen throughout the day per bottle instruction. Extreme fatigue Saturday night and severe headaches, fever at 100.2 F that night, treated with acetaminophen. By Sunday night temperature was 100.9 F, extreme fatigue and severe headaches and painful eye balls, heart rate racing up to 120 BPM when moving from bathroom to living room. Went back down to 65 BPM after about 1min at rest. Tried massages of upper body to loosen muscle, seemed to help with bodyache. Spent Saturday through Tuesday at home. Rapid covid 19 test negative. Back to work on Wednesday.
35 2021-01-16 tremor 2nd dose administered Thursday Jan 14th @ 2pm. Symptoms started Friday Jan 15th @ 0630 am. Became ... Read more
2nd dose administered Thursday Jan 14th @ 2pm. Symptoms started Friday Jan 15th @ 0630 am. Became extremely lightheaded/dizzy. Became nauseous. Felt as I was going to pass out. Made it to bathroom as I thought I was going to vomit. Essentially collapsed on floor and had severe rigors/uncontrollable shaking throughout entire body for 30 minutes. Felt as I was being electrocuted, it was extremely intense and could feel it through every part of my body. Teeth were clenched entire time and could barely open mouth. Attempted to get up multiple times but could not make it past getting on my knees. Laid on floor until shaking eventually subsided. Had severe headache after (i assume it was from clenching teeth for 30 min). Extreme fatigue. Was sent to ER per policy for covid test - results negative. Sent home from work per policy. Slept remainder of day. Woke up @ 5 pm feeling substantially better.
35 2021-01-17 weakness, tingling Severe cervical spine pain and stiffness with paresthesias in bilateral arms and weakness in right t... Read more
Severe cervical spine pain and stiffness with paresthesias in bilateral arms and weakness in right tricep and scapula. Took OTC acetaminophen and NDAIDs. Visited employees health who sent me to urgent care for neurological exam. Urgent care physician noted right arm weaker than left and recorded report of bilateral upper extremity paresthesia. Recommended follow up exam and cervical MRI if symptoms worsen or do not resolve within 7 days. Neck pain has improved but still present. Paresthesias still present. Right arm (dominant arm) still weaker than left. Will follow up with primary care physician this week if symptoms continue. Additional side effects: headache, dizziness, nausea, shivers, fatigue, joint pain (all resolved within 72 hours).
35 2021-01-20 weakness Headache, diahrea, weakness, upset stomach,
35 2021-01-24 feeling cold Felt headache and light headed at 230 am. Went to use reset room and felt a cold spell and dizzy. En... Read more
Felt headache and light headed at 230 am. Went to use reset room and felt a cold spell and dizzy. Ended up passing out and regained consciousness as I was falling head first down stairs.
35 2021-01-25 tingling pain on swallowing in the throat; throat started feeling itchy; pins and needles feeling; throat was... Read more
pain on swallowing in the throat; throat started feeling itchy; pins and needles feeling; throat was swollen; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL0140, expiry date unknown), via an unspecified route of administration on the left arm on 12Jan2021, 9:00AM at a single dose for COVID-19 immunization. The patient's medical history included asthma and allergies to Amoxicillin, Quinolones, and Sulfa drugs, all from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B 12); patient received these medications with two weeks of vaccination. 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, the patient had not been tested for COVID-19. On 12Jan2021, 19:00, just after evening, patient's throat started feeling itchy and had pins and needles feeling. Gradually the symptoms increased in intensity and in the night of 12Jan2021 (time unspecified), he felt like his throat was swollen. It was also reported that patient woke up today, 13Jan2021 with the same feeling and there is pain on swallowing in the throat. No therapeutic measures were taken in response to the events. Outcome of the events was reported as recovering.; Sender's Comments: Based on a chronological association, causality between events odynophagia, pharyngeal swelling and throat irritation 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 2021-01-26 pain in extremity Extreme arm soreness; Chills; Fever; Headache; It felt like he got the flu; This is a spontaneous re... Read more
Extreme arm soreness; Chills; Fever; Headache; It felt like he got the flu; This is a spontaneous report from a non-contactable pharmacist (patient). A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1686), via an unspecified route of administration in left arm, on 12Jan2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior to vaccination). There were no concomitant medications. No other vaccine was administered in four weeks. The facility where the vaccine was administered was in a nursing home or senior living facility. On 12Jan2021 at 10 PM, the patient had extreme arm soreness that did not go away with ibuprofen or paracetamol (TYLENOL). The patient had chills and a fever the night he got the injection. The patient also had a headache for 2 days after the injection (Jan2021). It felt like he got the flu in Jan2021. Post vaccination on 12Jan2021, the patient underwent COVID-19 nasal swab and PCR tests that was negative. Therapeutic measures were taken as a result of "Extreme arm soreness" including ibuprofen and paracetamol; no treatment was administered for the other events. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
35 2021-01-26 tingling, feeling hot Chest Pain SOB Feeling hot 30 min- numbness to mouth Tingling to hands/fingers Rest and recovered.
35 2021-01-27 bell's palsy 2 weeks out developed Bells palsy
35 2021-01-27 tingling C/o Tingling in hands, fingers, weakness in legs, mild lightheadedness. Legs elevated. Reaction tim... Read more
C/o Tingling in hands, fingers, weakness in legs, mild lightheadedness. Legs elevated. Reaction time 15 min from Vaccine admin. B/P slightly elevated 144/90...See document. Approached with mild tingling ...., lied down for 10 min. and felt better. Discharged to self at 7:15pm.
35 2021-01-27 tremor At night all of a sudden I got chills, shaking from the chills, 103 temp, body aches, and a headache... Read more
At night all of a sudden I got chills, shaking from the chills, 103 temp, body aches, and a headache the next day.
35 2021-01-28 tingling, numbness Facial tingling; facial tingling and numbness/cheek and eye feel swollen or numb; eye feel swollen o... Read more
Facial tingling; facial tingling and numbness/cheek and eye feel swollen or numb; eye feel swollen or numb; eye feel swollen or numb; cheek and eye feel swollen; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 14Jan2021 09:00 at single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient received the first dose of the COVID-19 vaccine yesterday morning at 9:00AM. The patient was experiencing facial tingling and numbness on unspecified date. He would like to know if this is a common side effect. He wanted to ask if numbness and tingling in the face a common side effect? The patient does not know if slept on his face or what but his left cheek and eye feel swollen or numb and stated that it was hard to describe. The patient noticed this this morning 15Jan2021. The patient stated, "it sort of feels like when you go to the dentist". The outcome of the event cheek swollen and eye feel swollen or numb was not recovered. The outcome of the remaining events was unknown.
35 2021-01-31 feeling hot Sat down, felt hot (left coat on), felt light headed, nauseated & nervous. Took coat off: felt bett... Read more
Sat down, felt hot (left coat on), felt light headed, nauseated & nervous. Took coat off: felt better. Lasted 10 min
35 2021-01-31 flushing 35 yo M w/PMH of asthma, allergies, w/acute onset of lower chest/epigastric pain, nausea, cough, and... Read more
35 yo M w/PMH of asthma, allergies, w/acute onset of lower chest/epigastric pain, nausea, cough, and feeling flushed within 30 minutes of Pfizer dose #1. T: 98.3 F, BP: 139/105, HR : 89, Ox 98% RA. CO is well appearing, not diaphoretic, w/clear lungs and normal heart sounds. No rash. PO Benadryl given at 13:07 PM d/t cough and CO observed until 13:24 w/resolution of chest discomfort and throat irritation. Tolerating sips of water. ER precautions discussed.
35 2021-01-31 cold extremities, feeling cold feeling cold; achy joints; mild to moderate headache; patient received second dose of bnt162b2 on 09... Read more
feeling cold; achy joints; mild to moderate headache; patient received second dose of bnt162b2 on 09Jan2021; head and torso fever while extremities like ice; head and torso fever while extremities like ice; Sporatic sweats; chills; body ache; Lingering lethargy; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EJ1685), via an unspecified route of administration on 09Jan2021 07:00 at single dose at right arm for covid-19 immunization. Medical history included asthma, rheumatoid arthritis, raynaud's, known allergies: nickel and latex. Concomitant medications in two weeks included salbutamol (ALBUTEROL), fluticasone propionate (FLONASE), ascorbic acid (VIT C), ergocalciferol (VIT D) and multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient previously took erythromycin and experienced drug allergy, and received first dose of bnt162b2 on 23Dec2020 for covid-19 immunization and experienced splitting trident occipital headache/Dull ache in frontal skull region. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 2nd injection-15hrs post injection, patient began feeling cold and achy joints, mild to moderate headache on 09Jan2021 10:00 pm, by 3am head and torso fever while extremities like ice. Over several days ran fevers from 99.1 to 103.6 F. Sporatic sweats, chills, and body ache attacks. Symptoms gradually subsided in severity and duration until resolving one week post injection. Patient also had lingering lethargy in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive treatment for events. Outcome of events lingering lethargy and 'patient received second dose of bnt162b2 on 09Jan2021' was unknown, and outcome of other events was recovering.
35 2021-02-03 bell's palsy Bell?s palsy
35 2021-02-03 pain in extremity dizziness; nausea; pain all over the body; severe headache; excessive flatulence; Fever 40 Degree C/... Read more
dizziness; nausea; pain all over the body; severe headache; excessive flatulence; Fever 40 Degree C/severe fever; pain in knees, ankles and foot the first day; pain in knees, ankles and foot the first day; administration date= 04Jan2021, dose number=2/administration date=18Dec2020, dose number=1; This is a spontaneous report from a contactable healthcare professional. A 35-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ES1686), intramuscular on 04Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 (first dose). The patient experienced fever 40 Degree C, pain in knees, ankles and foot the first day (on 04Jan2021 21:00); second day (05Jan2021) dizziness, nausea, severe fever, pain all over the body, severe headache, excessive flatulence. Symptoms lasted a week. Treatment included Panadol every 4 hours. The patient went for an emergency visit for the events. The outcome of the event was recovered in Jan2021.
35 2021-02-03 tenderness, feeling cold Severe abdominal pain. The shot was given at approx 11 am. Abdominal pain started around 6 pm, gra... Read more
Severe abdominal pain. The shot was given at approx 11 am. Abdominal pain started around 6 pm, gradually got worse. At 1 am I was awoken in pain and I took hydrocodone leftover from a previous surgery in hopes of making it to the morning for urgent care. (ER Bills) At 4 am I was re-awoken in even worse pain, decided I was about to die, and went to the ER. Cold sweat on way to ER. Throat dry. Made it to ER, received Morphine, the first dose calmed the pain down, did not make it go away. A lot of tests and several hours later, a second dose was given when the pain returned to its terrible state. Approx 15 min into the second dose pain was finally subsiding (roughly 1 or 2 pm). Went home and took Tylonal as requested by Docs and filled an Oxy prescription in anticipation of the return of the pain. This has not happened. Slept great last night. Dry Mouth Persists. Also slight arm tenderness.
35 2021-02-07 hot flush, numbness Left side of my face is numb/hot, neck sore, hot flashes, shortness of breath when walking
35 2021-02-07 numbness, pain in extremity Sharp pain (8/10) radiating down arm accompanied by numbness in left hand. Started on Saturday, 2/6... Read more
Sharp pain (8/10) radiating down arm accompanied by numbness in left hand. Started on Saturday, 2/6, at the injection site and has progressively gotten worse since then. Also having a constant headache starting on Saturday, 2/6. HA started out as a 4/10 and has progressed to 6/10 on pain scale.
35 2021-02-08 numbness Numbness in pinky and ring finger of the left arm.
35 2021-02-11 tingling, cold extremities, numbness Within a few days of first shot, I developed a sort of numbness/tingling/cold feeling in my 2nd and ... Read more
Within a few days of first shot, I developed a sort of numbness/tingling/cold feeling in my 2nd and 3rd toes on my right foot. Over time the symptoms have spread and I developed small sores on my feet. I also am feeling some slight tingling and cold feelings in my hands/fingertips but no blisters at this time.
35 2021-02-16 feeling jittery About 5 minutes after receiving the vaccine, I got very lightheaded and my heart started pounding. T... Read more
About 5 minutes after receiving the vaccine, I got very lightheaded and my heart started pounding. There were a few moments during the first half hour of receiving the shot that I thought I might pass out. When the nurse took my blood pressure it was 184/81, which is not normal for me. It took about an hour for it to get back down to a normal level. Afterwards, I felt very jittery for a while.
35 2021-02-17 pain in extremity Sore arm; This is a spontaneous report from a non-contactable consumer. A 35-year-old male patient (... Read more
Sore arm; This is a spontaneous report from a non-contactable consumer. A 35-year-old male patient (age at vaccination 35-years-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. At the time of the report, the patient recovered from the event on an unspecified date. No treatment was received for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. It was unknown if the patient had been COVID tested post vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained.
35 2021-02-18 flushing Pfizer-BioNTech COVID-19 Vaccine EUA Patient woke up with sudden onset shortness of breath. Felt flu... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Patient woke up with sudden onset shortness of breath. Felt flushed and heart racing. Went to Emergency Department. He received oxygen, aspirin, atorvastatin, fluids, and midazolam. Resp rate 25 BPM. BP 137/89 mmHg Heart rate 105 BPM Has family history of heart disease
35 2021-02-21 pain in extremity Received first vaccine on 2/17/21, had left arm soreness and swelling the next day which continued t... Read more
Received first vaccine on 2/17/21, had left arm soreness and swelling the next day which continued to get worse. Went to urgent care on 2/22/21 diagnosed with vaccine reaction.
35 2021-02-23 numbness, pain in extremity pain and numbness in left arm resolved within 3 days / right foot pain continues, pressure headache ... Read more
pain and numbness in left arm resolved within 3 days / right foot pain continues, pressure headache that resolved within minutes
35 2021-02-24 hot flush Hot flush, extreme dizziness, and vomiting
35 2021-02-27 pain in extremity Right shoulder pain (where I received the vaccine) Very very tired post 48 hours
35 2021-02-28 flushing Started to feel aches and fatigue that evening of the vaccine (2/18) and then woke up in pain around... Read more
Started to feel aches and fatigue that evening of the vaccine (2/18) and then woke up in pain around midnight (2/19). Had horribly body aches, was extremely flushed, tachycardic and short of breath. The respiratory distress kept increasing which is why I ended up going to the ER.
35 2021-03-01 discomfort Swollen lymph nodes in shoulder and neck on same side as shot. Radiating discomfort into neck, shoul... Read more
Swollen lymph nodes in shoulder and neck on same side as shot. Radiating discomfort into neck, shoulder and arm.
35 2021-03-01 pain in extremity I tested positive for covid on ~11/26. Relatively mild case with mild fatigue and lost of taste and ... Read more
I tested positive for covid on ~11/26. Relatively mild case with mild fatigue and lost of taste and smell. Possibly some worsening exercise tolerance ~3-4 weeks after initial onset date. I'm not sure if it was deconditioning vs lingering covid effects. No side effects from first covid vaccine minus a sore arm. After second dose some mild fatigue ~2 days. Then 12 days after second dose significant more fatigue and in the next few days chills at night and tachycardia with pulse in 120s at rest. No fever, pain, sob, swelling or other symptoms. Presented to immediate care on 2/27 predominantly for the tachycardia. Was referred to the ED. Discharged on 3/1 on metoprolol with possible diagnosis of viral myocarditis.
35 2021-03-03 cold sweat In monitoring parking lot, client waved down staff reporting he may have lost consciousness for arou... Read more
In monitoring parking lot, client waved down staff reporting he may have lost consciousness for around 10 minutes. Client had pale clammy skin that improved with mild activity. Client reported noticing red spots on his nose, not witnessed by monitoring staff. Client also reported have trouble drawing in deep breaths. EMS was activated and client was transported to ER for further evaluation.
35 2021-03-04 pain in extremity Pain in arm/sore arm; This is a solicited report from a contactable consumer (patient) based on the ... Read more
Pain in arm/sore arm; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from another company (MFR. Control No.: 20K-163-3447228-00). A 35-year-old male patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: e10142, expiry date: Mar2021), intramuscular on 11Jan2021 at single dose for covid-19 immunisation, adalimumab (HUMIRA), subcutaneous from Sep2019 to an unspecified date, 10Jun2020 to Jun2020 and 24Jun2020 and ongoing at 40 mg (40 mg, 1 in 1 wk) for Moderate to Severe Hidradenitis Suppurativa. Medical history included hyperlipidaemia, high cholesterol, depression, hypothyroidism, sleep apnea from an unknown date and unknown if ongoing, Down syndrome from 31Jan1985 to an unknown date, pneumonia from 1986 to 1986, open heart surgery in May1988, May1994 and Jul2012, acute respiratory distress syndrome from 08Dec2002 to 04Apr2003, aspiration pneumonia from 08Apr2003 to 15Apr2003 and clinical trial participant in 11Jan2021. Concomitant medication included atorvastatin at 20 mg for high cholesterol and hyperlipidemia, fluoxetine at 40 mg for depression, levothyroxine at 0.75 mg, 1 in 2 D for hypothyroidism and sleep apnea, colecalciferol (VITAMIN D3 1000) for supplement. The patient previously took Reglan and experienced vomiting, confusion and disorientation, Percocet and experienced vomiting and disorientation, Toradol and Zofran and experienced vomiting, confusion and disorientation; Humira for moderate to severe hidradenitis suppurativa in Sep2019 and experienced abdominal hernia on Nov2019 which resolved in 19Jun2020 and hidradenitis suppurativa breakout underarm and in groin area/hidradenitis suppurativa flare in Sep2019 which resolved on an unspecified date. The patient experienced pain in arm/sore arm on 12Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on an unspecified date, ultrasound abdomen: unknown results (Abdominal Hernia that needed surgical repair) on 11Jan2020. The action taken in response to the event for adalimumab was dose not changed. The patient recovered from the event on 13Jan2021. The reporter assessed the event as probable to the drug and vaccine.; Sender's Comments: There is a reasonable possibility that the event pain in arm/sore arm was related to BNT162b2 based on known drug safety profile and close temporal relationship.
35 2021-03-05 migraine Blurred vision. Migraines. Inability to sleep. Anexiety.
35 2021-03-07 pain in extremity Left lower portion of my leg ached; This is a spontaneous report from a contactable consumer (patien... Read more
Left lower portion of my leg ached; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received first dose of BNT162B2 (lot number: EL3248), via an unspecified route of administration on the left arm on 28Jan2021 at 08:15 at a single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient had no known allergies. No other vaccine was given in four weeks. No other medications was given in two weeks. No covid prior vaccination. No covid test was done post vaccination. The patient experienced Left lower portion of leg ached. It felt like similar to growing pains experienced as a child. Lasted only one night, the same day as when I received the shot. No treatment was received in response to the adverse event. The next day (29Jan2021) the pain was gone. The patient was not allowed to contact hcp. The patient recovered from the event on 29Jan2021.
35 2021-03-07 tingling Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms started to occur approximately 10 min after injection... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms started to occur approximately 10 min after injection. Symptoms included tingling sensation in face and brief period of lip numbness. I did not have any rash or respiratory issues. All noted symptoms resolved within 1 hour without any medication. I initially did not report these issues to the pharmacy where I received the shot.
35 2021-03-07 tremor, migraine Uncontrollable shaking for approximately 2hrs, leading into severe migraine and entire body ache for... Read more
Uncontrollable shaking for approximately 2hrs, leading into severe migraine and entire body ache for 24 hours. Possible fever but was unable to get out of bed to get a thermometer.
35 2021-03-08 numbness cold throughout body, increased HR, Numbness in hands and feet, dry throat. Evaluated by EMS-Cleare... Read more
cold throughout body, increased HR, Numbness in hands and feet, dry throat. Evaluated by EMS-Cleared
35 2021-03-09 weakness, pain in extremity, night sweats nausea; weakness; fever; photophobia; body aches; night sweats; chills; headache; arm pain; This is ... Read more
nausea; weakness; fever; photophobia; body aches; night sweats; chills; headache; arm pain; This is a spontaneous report from a contactable Pharmacist (Patient). A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EL3246) via intramuscular in the left arm on 13Jan2021, at 12:30 (at the age of 35-year-old) as a single dose for COVID-19 immunization. The patient medical history included ulcerative colitis, adhd (Attention deficit hyperactivity disorder), prediabetes, high cholesterol. The patient did not have any allergies to medications, food, or other products. 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 concomitant medication included mesalazine (LIALDA), methylphenidate hydrochloride (CONCERTA), cetirizine hydrochloride (ZYRTEC), vitamin d, citalopram and atorvastatin. The patient previously took historical vaccine first dose of bnt162b2 (Lot number: EK5730), via intramuscular, on left arm on 22Dec2020, at 16:30 (at the age of 35-year-old) for COVID-19 immunization and experienced arm pain. On 13Jan2021, the patient experienced arm pain at 13:30 and, headache at 14:30. On 14Jan2021, at 00:30 body aches, night sweats, chills and at 12:30 patient had fever and photophobia. On 15Jan2021, at 12:30 the patient had weakness. On 16Jan2021 at 12:30 the patient had nausea. The patient did not receive any treatment for the events. The outcome of the events was reported as non-serious. The outcome for all the events was recovered on an unknown date in 2021.
35 2021-03-10 weakness Difficulty breathing, pain and weakness all over. Felt as if my lungs were bruised, dizzy and unable... Read more
Difficulty breathing, pain and weakness all over. Felt as if my lungs were bruised, dizzy and unable to keep food down. I was given steroids and fluids along with a shot of ketorolac
35 2021-03-11 tension headache, muscle spasms Severe muscle spasms, fever, fatigue, headache, tightness, soreness
35 2021-03-13 weakness, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Head... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Medium, Systemic: Weakness-Medium
35 2021-03-13 pain in extremity One hour after the injection, my brain began to feel hazy. My short-term memory was terrible. Rememb... Read more
One hour after the injection, my brain began to feel hazy. My short-term memory was terrible. Remembering simple tasks was very difficult. The best way I can describe it is that it felt like I had consumed marijuana. I do not use marijuana or any other drugs. I had not consumed alcohol. The effects were similar to that of marijuana in that there was a ?peak? and a ?come-down.? The peak lasted a little more than one hour, and began about one hour after the injection. The effects slowly faded until I didn?t feel completely normal until I woke up this morning. Today, I have no symptoms other than a sore arm.
35 2021-03-13 pain in extremity Sor arm with loss of range of motion in shoulder. Red then large bruise at injection site. Fatigue f... Read more
Sor arm with loss of range of motion in shoulder. Red then large bruise at injection site. Fatigue for 3 days. First shot only.
35 2021-03-15 face paralysis, facial paralysis Patient received his first dose of Pfizer covid19 vaccine on 3/5/21. Over the next few days he devel... Read more
Patient received his first dose of Pfizer covid19 vaccine on 3/5/21. Over the next few days he developed progressive right facial weakness and was evaluated in the emergency dept. It progressed over the next week to severe R sided facial nerve palsy and has remained in this condiiton at the time of this report. He was started on Valacyclovir and prednisone with minimal improvement
35 2021-03-15 migraine Migraine Headache
35 2021-03-16 feeling hot Progress Notes (Nurse Practitioner) Family Medicine Cosigned by: MD at 3/16/2021 9:55 AM Expand All... Read more
Progress Notes (Nurse Practitioner) Family Medicine Cosigned by: MD at 3/16/2021 9:55 AM Expand AllCollapse All COVID VACCINE CLINIC 3/15/2021 Subjective Patient is a 35 y.o. male who was seen at COVID 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 hot sensation in L side of chest. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, 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 , chest pain, collapse, rapid progression of symptoms and respiratory distress. No medical hx. Not on any medications ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, ear pain, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, abdominal pain, muscle aches, joint pain and dizziness Denies cp: No injection site pain: Previous Reactions: none to vaccines Objective Vitals Vitals: 03/15/21 1520 03/15/21 1533 BP: (!) 147/82 134/77 Pulse: 69 76 SpO2: 98% 98% Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is not ill-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. 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. Comments: Speaking full sentences. Skin: General: Skin is warm. Coloration: Skin is not pale. Findings: No rash. Comments: No tenderness on chest wall or L deltoid with palpation. 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. Assessment/Plan Treatment included: no therapy 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) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Pt observed in medical bay for approx 15 mins. Chest hotness resolved in medical bay after 5 minutes of being in bay. He denies any other concerns. Possible anxiety/ stress response. VS and exam stable. Reassuring. Pt to follow up with pcp as needed. Discussed reasons to go to ED if needed. Pt voices understanding and is appreciative of his care today. Pt is predominantly Spanish-speaking. Translator used: Myself. Electronically Signed 3/15/2021 3:58 PM
35 2021-03-17 tingling, numbness, face paralysis TINGLING AND NUMBNESS OVER THE LEFT CHEEK AND JAW, ALONG WITH WEAKNESS AT THE LEFT CORNER OF THE MOU... Read more
TINGLING AND NUMBNESS OVER THE LEFT CHEEK AND JAW, ALONG WITH WEAKNESS AT THE LEFT CORNER OF THE MOUTH. FULLY RESOLVED SYMPTOMS AFTER 2 DAYS.
35 2021-03-18 facial pain Swelling in my left cheek with a red area on the surface.; Swelling in my left cheek with a red area... Read more
Swelling in my left cheek with a red area on the surface.; Swelling in my left cheek with a red area on the surface.; "skittle" in the flesh of my cheek; still very sore and swollen; This is a spontaneous report from a contactable consumer. A 35-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot_number EN5318) via an unspecified route of administration, in Arm Left on 09Feb2021 10:15 at single dose for covid-19 vaccination. The patient medical history was not reported. Concomitant medication included tizanidine 4 mg ; cannabidiol 10 mg. The patient previously received first single dose of bnt162b2 on 19Jan2021 12:15 PM unknown route left arm single for Covid-19 immunization. Patient previously took Nortriptyline had allergy. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination: Tizanidine 4mg, CANNABIDIOL 10mg, adult mens multi-vitamin. On 09Feb2021 16:00, Patient had swelling in my left cheek with a red area on the surface. The area was first noticed when it felt like there was a "skittle" in the flesh of my cheek. It then grew at a slow rate Tuesday evening. During Wednesday it swelled to the size of a large grape before bed last night. This morning the swelling has gone down slightly, but the area is still very sore and swollen. I have sent a message with photos to my doctor and am waiting to hear back if I should go into the clinic or wait to see if the swelling continues to go down. The reporter considered all events was non-seriousness. The patient received treatment was reported as unknown. The outcome of the events was unknown. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient been not tested for COVID-19.
35 2021-03-20 seizure Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Medium, Additional Details: Patient recieved first dose of Pfizer vaccine administered by Staff. Patient appeared confused and lethargic appearing to pass out. Staff administered epinephrine. Patient then started to seize ~2 mins. Patient was then reponsive. Emergency services came and took patient to hospital.
35 2021-03-23 tingling Hand on arm that shot was administered has a tingling feeling that has been going on since a couple ... Read more
Hand on arm that shot was administered has a tingling feeling that has been going on since a couple hours after shot. Feels like when your hand is "waking up" after "falling asleep" doesn't hurt, it just won't stop doing it
35 2021-03-23 tremor Patient went stiff and went unconscious. Patient was then assisted to the floor by a staff member fr... Read more
Patient went stiff and went unconscious. Patient was then assisted to the floor by a staff member from the chair. Patient shortly after regained consciousness. Patient was then alert and oriented but had no memory of what happened. Pt was shakey and light headed. EMS was called to the scene. Pt was then transported by ems to the hospital. No epi pen was used.
35 2021-03-24 tingling, weakness, numbness tingling, numbness and generalized weakness, headache, palpitations with in a few minutes of adminis... Read more
tingling, numbness and generalized weakness, headache, palpitations with in a few minutes of administration of the vaccine
35 2021-03-25 bell's palsy Classical Bell's Palsy symptoms, right side of the face. Treatment began with valtrex and prednisone... Read more
Classical Bell's Palsy symptoms, right side of the face. Treatment began with valtrex and prednisone on 03/23/2021. No decrease (or increase) in symptoms so far.
35 2021-03-25 cold sweat Two minutes after receiving his vaccine he started to get lightheaded and dizzy, cold sweats, nausea... Read more
Two minutes after receiving his vaccine he started to get lightheaded and dizzy, cold sweats, nausea, and he was bradycardic. Ammonia was used while he was in the POD. He was removed from the cell and brought to the medical observation area. His blood pressure on arrival was 119/68, heart rate 71, pulse ox on room air was 99%. Patient was placed in trendelenberg for about 10 minutes. His follow up blood pressure was 113/68 @ 2:49. About 5 minutes later hw as placed in a semi fowlers position with his follow up blood pressure was 127/62, HR 72. , subsequent in a sitting position was 113/68 HR 74, and in a standing position 125/64. Patient reported his symptoms have resolved.
35 2021-03-26 cold sweat Patient fainted after getting vaccination, bumped the car in front of him. Did not remember hittin... Read more
Patient fainted after getting vaccination, bumped the car in front of him. Did not remember hitting the car. He was diaphoretic, clammy, palor in color, VSS but low, patient stated that he vagals with all shots. He was removed from his car and taken to the emergency tent. laid on a cot with his legs elevated. His vital signs were: 80/40, 49, 98%, 88/60, 56, 99%; 100/64, 78, 96%; 110/68, 64 98% Patient stated that he was feeling better, he runs a low blood pressure and frequently gets orthostatic hypotension.
35 2021-03-26 pain in extremity Inflammatory arthritis and tendonitis in my left thumb. Isolated swelling and pain to my proximal in... Read more
Inflammatory arthritis and tendonitis in my left thumb. Isolated swelling and pain to my proximal interpharangeal joint of Left first finger. Symptoms have been persistent since onset. Remain present today. No prior history. No trauma or over use. I am right hand dominant.
35 2021-03-27 grand mal seizure, seizure Patient thought he sat in chair in observation area but he fell on the ground and began to seize. Mu... Read more
Patient thought he sat in chair in observation area but he fell on the ground and began to seize. Multiple nurses and EMTs responded and found the patient in tonic-clonic seizure. Pt continued to seize for about 10 seconds and upon exiting the seizure he reported that this happened about 4 years ago The patient repeatedly declined to be transported to the hospital.. He was incontinent and finally he agreed to be transported to a nearby hospital to be checked out.
35 2021-03-31 migraine Events occurred approximately 17 hours from shot. Low fever (between 99.4 and 100.6F) for about 18 h... Read more
Events occurred approximately 17 hours from shot. Low fever (between 99.4 and 100.6F) for about 18 hours. Headache/migraine lasting 20 hours. No treatment sought and no medication taken.
35 2021-03-31 tingling Itchy throat, dry mouth and tingling to left arm
35 2021-04-01 pain in extremity, numbness Arm soreness around 5:00 pm on day of vaccination Lips began tingling at 7:54 pm on day of vaccinati... Read more
Arm soreness around 5:00 pm on day of vaccination Lips began tingling at 7:54 pm on day of vaccination Facial numbness and mild muscular weakness by 8:15pm
35 2021-04-01 tremor, muscle spasms Craps, Pains, Shakes, Chills, Pulsing Pain , Lost of taste
35 2021-04-02 pain in extremity Shoulder injury, very painful arm and back, still ongoing.
35 2021-04-02 pain in extremity Elevated blood sugars, sore arm, tired, tunnel vision.
35 2021-04-02 unresponsive to stimuli, flushing Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted and hit his head on the way down. Was unresponsive for <10 seconds and came to then was able to sit up and hold a conversation. Had 2 orange juice bottles and patient communicated that this was a known issue with needles.
35 2021-04-03 weakness After second shot, felt drowsy quickly. Next day I had fever of 101, chills, pounding headache, shar... Read more
After second shot, felt drowsy quickly. Next day I had fever of 101, chills, pounding headache, sharp pain headache, weakness, pain at injection site, aches, couldn't sleep. Did not treat with any medication. Felt fine the next day, except a little fatigue.
35 2021-04-04 tremor, flushing Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Additional Details: Patient was lightheaded and fainted post vaccine. He was non responsive for a few seconds. 911 was called and EMS treated patient on site. Patient denied hosptial visit.
35 2021-04-05 involuntary muscle movements Pt received vaccination to left deltoid. Soon after shot pt had a syncopal episode with jerking mo... Read more
Pt received vaccination to left deltoid. Soon after shot pt had a syncopal episode with jerking movement. Was assisted to floor with help of nursing staff. Placed on left side. A/Ox3. V/s obtained with b/p 136/68 Hr 48 O2 98% on RA. RR18 even and unlabored. EMS notified. No acute distress noted, Father was contacted and at pt side. EMS arrived with full assessment of pt. He refused to go to hospital. V/S obtained again with HR 66 b/p 110/71. Pt went from side lying position to a standing position. Ambulated to waiting area with steady gait. Waited 30 min before leaving with father at his side. After 30 min pt was free to go. Denies any problems before leaving. V/s 134/64 HR 61 O2 100% on RA.
35 2021-04-05 tingling Vaccine Reaction: Nauseated, Syncope and sweating Description of Event: Pt found in observation ch... Read more
Vaccine Reaction: Nauseated, Syncope and sweating Description of Event: Pt found in observation chair, sweaty and nauseous and had about a 1 minute syncopal episode observed by OBS RN. Pt slow to arouse post syncope. Able to ambulate 2 steps and placed on gurney. Taken outside of the building by exit doors. Pt sleepy and sweaty, placed on vital sign machine. Dr. and multiple RN's with patient. Pt remained slightly nauseous at 1033. Pt had eaten breakfast and denies any medical history or meds. 1035 attempt sips of water, 1038 we called his girlfriend to come be with him and drive him home. Pt felt like he couldn't get enough air at 1038, we removed both of his masks at this time. Pt was sweaty again, but oxygen sats were 100%. 1056 GF arrived. 1106 we attempt to sit up patient slightly and he gets lightheaded and request to lie flat again. Sips of water causes nausea. Dr. remains at BS with patient. Pt began feeling a whole body tingle, encouraged to take nice slow easy breaths. 1111 took a bite of granola bar. 1143 tried sitting up again, gets lightheaded and laid back down. 1154 Dr. back at bedside. 1200 Pt cold bath blanket put on patient. Pt had periods of being slightly pale during observation period and dry mucuous membranes.Pt refusing to try water or granola bar at this time. 1205 pt began to vomit stomach contents.1212 Dr. back at BS to evaluate patient. Pt feels slightly better, taking sips of water. 1220 pt has been able to lay with head up on his left side now for 20 mins. Dr. offered to send patient to ER to get IVF and be checked out, pt began to perk up and wanted to go home. Orthostatic VS done and remain stable. GF is agreeable to take patient home and monitor him, she is not going in to work today. Pt taken to car via wheelchair, assisted in car, able to walk a few steps. Advised by Dr. to eat a salty meal and drink plenty of fluids and rest. Go to ER if symptoms worsen. Also advised by this RN to follow up with his PCP and let them know of his syncope with vaccine. Pt also advised if he dose get the second vaccine to let them know up front he faints and will be given vaccine in reclining chair.
35 2021-04-05 unresponsive to stimuli, flushing, cold sweat Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: approximately 10 minutes after dose patient blood pressure dropped, eyes dilated, clammy. sweating. First responders came, pt did not leave with them but was going to hospital to \"get checked out\".
35 2021-04-06 bell's palsy I seem to be experiencing slight Bell's Palsy on the right side of my face.; This is a spontaneous r... Read more
I seem to be experiencing slight Bell's Palsy on the right side of my face.; This is a spontaneous report from a contactable nurse reporting for himself. A 35-year-old male patient received the first dose of BNT162B2 (Lot Number: EN6204), intramuscular, administered in left arm on 20Mar2021 14:00 (at the age of 35-year-old) at single dose for COVID-19 immunization. Medical history included autoimmune encephalitis and obesity. No known drug allergies. Concomitant medications included aripiprazole (ABILIFY); clonazepam; propranolol; lithium carbonate (LITHEUM); naltrexone; benzatropine mesilate (COGENTIN); dexmethylphenidate hydrochloride (FOCALIN XR ER); dexamethasone, ofloxacin hydrochloride (FOCALIN); desvenlafaxine succinate (PRISTIQ); amoxicillin trihydrate, clavulanate potassium (AUGMENTIN BD); levothyroxine sodium (TIROSINT); iron (FE 10); probiotics and multivitamins (MV). No other vaccine in four weeks. No Covid prior vaccination nor tested with Covid post vaccination. The patient seems to be experiencing slight bell's palsy on the right side of his face on 22Mar2021 08:30. It was unknown if treatment was received for the event. The outcome of the event was unknown.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the event facial paralysis. 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 2021-04-06 flushing Site: Itching at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Syst... Read more
Site: Itching at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Mild, Systemic: Nausea-Medium
35 2021-04-06 tingling client complained of left hand tingling 5 mins after receiving first Pfizer Covid Vaccine (lot# EW01... Read more
client complained of left hand tingling 5 mins after receiving first Pfizer Covid Vaccine (lot# EW0150, Exp 4/11/21). Client was sitting on chair approximately 4 mins when he felt tingling sensation to hand and alerted EMTs. PHN joined right after. Client alert and oriented. Client denied pain or radiation of tingling. Client able to move hand and arm freely. First vitals: blood pressure 140/80, pulse 91, oxygen 99%. Client just had vaccine on left arm, no complaints at site of injection. Allergy to penicillin, client agreed to stay 30 mins for observation. Per client 140 blood pressure is his normal, no history of hypertension, but is aware is a little higher than normal. Other pertinent medical history: prediabetes, no current medications. Vitals at 1645: blood pressure 130/90, pulse 85, oxygen 98%. Client reported tingling sensation same, not worsening or radiating. Alert and oriented. Last set of vitals at 1658: blood pressure 130/90, pulse 87, oxygen 97%. Per client improvement of tingling on left hand. No other complaints. Client advised to seek medical help if symptom worsened. ER precautions given as well. Client stated feeling well to leave. Client left with steady gait at 1701
35 2021-04-07 cold sweat had complaints of dizziness, diaphoresis after shot while sitting in chair, was about to notify some... Read more
had complaints of dizziness, diaphoresis after shot while sitting in chair, was about to notify someone and had witnessed fall to ground, head first out of chair, fell to ground and had 15 sec syncopal episode, with thready pulse noted, barely palpable, pale, and clammy. feet put up on chair, ammonia tx, regained consciousness, and rolled onto backboard and transported to obs via stretcher, answering appropriately at this time. left forehead abrasions noted. 1105: bp 137/85 hr 76 rr 18 sats 99% on ra. PERRL. 1115: bp 136/86 hr 88 rr 16 sats 100% on ra, feeling better per patient. advised to go via ems for further eval for possible imaging by md and nurses, refusing, as has syncopal episodes in past similar to this with falls. 1124: bp 144/90 hr 81 lying, bp 135/88 hr 82 sitting, bp 126/89 hr 81 standing; asymptomatic. patient states feeling back to baseline. instructed on ss to monitor for and to go to ed. escorted to private vehicle with no further issues.
35 2021-04-07 seizure Patient was having seizure symptoms within 10 mins of receiving his first dose of the COVID-19 Pfize... Read more
Patient was having seizure symptoms within 10 mins of receiving his first dose of the COVID-19 Pfizer vaccination. 911 was called immediately and while the EMS was arriving to the scene patient was starting to feel better. There was no reports of any signs of trouble breathing. EMS arrived on the scene and assessed the patient. Patient refused to go to the hospital with the EMS and reports to be feeling fine. Recommendations to follow up with a physician was advised.
35 2021-04-08 face paralysis, numbness Tiredness; headache; slight numbness of right side of face; slight loss of muscle control in right s... Read more
Tiredness; headache; slight numbness of right side of face; slight loss of muscle control in right side of face; This is a spontaneous report received from a non-contactable consumer (patient). A 35-year-old male patient received first dose of bnt162b2 (Batch/Lot Number: 953738), at the age of 35-year-old via an unspecified route of administration, administered in left arm on 21Mar2021 as single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced tiredness, headache, slight numbness of right side of face, slight loss of muscle control in right side of face all on 27Mar2021 16:00. No treatment received for the adverse events. The events were reported as non-serious. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. 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 hadn't been tested for COVID-19. Not allergies to medications, food, or other products. The outcome of events was not resolved.
35 2021-04-08 muscle spasms Severe lower back pain and cramping of lower back muscles.
35 2021-04-09 flushing, weakness Pt reported weakness with flushing. Denies LOC. Administered crackers and water and placed pt in lyi... Read more
Pt reported weakness with flushing. Denies LOC. Administered crackers and water and placed pt in lying position in stretcher in med obs #1. VS at 0843: BP 160/93, HR 89, RR 18, O2 sat 99% on RA. VS at 0906: BP 137/89, HR 78, RR 17, O2 sat 99% on RA. Pt sent home independently after recovering, VSS at time of discharge. Escorted to facility exit.
35 2021-04-09 hot flush Pt reports feeling dizzy & a "rush of heat", & sweating 1 minute after vaccination. Also reports tun... Read more
Pt reports feeling dizzy & a "rush of heat", & sweating 1 minute after vaccination. Also reports tunnel vision, but resolved w/in 2 minutes after receiving vaccine. Pt reports similar experiences w/ injuries. Pt remained on site for 30 minutes after vaccine with no worsening symptoms. Pt left the vaccine clinic LOC X4.
35 2021-04-09 numbness Restong heart rate jumped to 100bpm when normal resting rate 8s 58 to 60bpm. Normal heart rate retur... Read more
Restong heart rate jumped to 100bpm when normal resting rate 8s 58 to 60bpm. Normal heart rate returned after 4 minutes. Jaw line, nose, back of the head and upper back went numb for 6+ hours after 1st vaccine. Second vaccine administered on March 18th at 1130. Jaw line and nose went numb for entire day. Woke up next morning and it was back to normal. A cough and chest pain started March 20th and it still is present today(April 9th) Primary doctor is useless and can't help.
35 2021-04-09 migraine I started experiencing dizziness and lightheadedness about two weeks after my first shot. I had inte... Read more
I started experiencing dizziness and lightheadedness about two weeks after my first shot. I had intense migraines for about a week as well. I also suddenly get intense stomach pains whenever I eat bananas or pineapples, two foods I used to previously enjoy without issue
35 2021-04-09 pain in extremity Start Date/Time: 8-MAR-2021 11:30 AM/15-JAN-2021 02:00 PM; Start Date/Time: 8-MAR-2021 11:30 AM/15-J... Read more
Start Date/Time: 8-MAR-2021 11:30 AM/15-JAN-2021 02:00 PM; Start Date/Time: 8-MAR-2021 11:30 AM/15-JAN-2021 02:00 PM; Fever; Arm Pain; Body Aches; Left Under Arm Lymph Node Swelling and Pain; Left Under Arm Lymph Node Swelling and Pain; This is a spontaneous report from a non-contactable consumer (patient). This 35-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 08Mar2021 at 11:30 (at the age of 35-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient previously received dose 1 of BNT162B2 (lot number EL9263) on 15Jan2021 at 14:00 (at the age of 34-years-old) as a single dose in the left arm for COVID-19 immunization. On 09Mar2021 after dose 2 of BNT162B2, the patient experienced fever, arm pain, body aches, and left underarm lymph node swelling and pain. The events were reported as non-serious. The patient was not hospitalized for the events. The patient was treated for the events with acetaminophen (TYLENOL) from an unspecified date. The outcomes of fever, arm pain, body aches, and left underarm lymph node swelling and pain were 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.
35 2021-04-10 numbness, face paralysis pt w/ 3wk of posterior neck pain and headache after second dose that did not improve with OTC meds. ... Read more
pt w/ 3wk of posterior neck pain and headache after second dose that did not improve with OTC meds. on 4/10/21 @ 6pm pt noticed that he could not swallow and was drooling, His L face and body was numb so he presented to the Ed. Pt was worked up for angioedema at first . then symptoms progressed to R sided facial weakness and CODE stroke was activated. Found to have R vertebral artery occlusion, R PICA occlusion secondary to distal vertebral artery dissection and pt was given TPA. Neuro exam slowly improving.
35 2021-04-11 pain in extremity flu like symptoms, aches, sore arm, fever, headache, loss of vision
35 2021-04-12 numbness Typical advertised reactions with one exception - Slight numbness/tingling radiating from the inject... Read more
Typical advertised reactions with one exception - Slight numbness/tingling radiating from the inject site - left shoulder. This started about 90 minutes after vaccination. It originated at the injection site and moved down the arm into the left hand. At 120 minutes after injection it moved into the neck, face, ear and scalp - again only on the left side. The following day numbness and tingling sensation is about half as strong. At times it fades and but comes back. Muscle movements were not impacted and sense of touch remained. As of 30 hours after the injection I have not sought out treatment.
35 2021-04-12 tingling Shortness of breath, runny nose, racing heart, headache, shivering, ringing ears, tingling hands and... Read more
Shortness of breath, runny nose, racing heart, headache, shivering, ringing ears, tingling hands and fingers, paranoia, nightmares, hallucinations, panic attacks
35 2021-04-12 unresponsive to stimuli, slow speech Pt to observation after receiving vaccine. Immediately upon entering observation, pt complained of d... Read more
Pt to observation after receiving vaccine. Immediately upon entering observation, pt complained of dizziness and feeling as though he was going to pass out. RN to vehicle to assess per request of observation staff. Once RN approached car and began to speak with pt, she noted pt to be very pale, diaphoretic and speaking sluggishly. RN laid pt drivers seat all the way back and elevated his feet, pt wife who also received vaccine was in the passenger seat. After pt laid back his eyes rolled back and he became unresponsive. Medics and MD called to evaluate. After sternal rub pt noted to have eyes open and pupils dilated, still unresponsive. Within the minute the medics arrived and pt began to regain consciousness. Pt states he has had this happen before when he has had blood drawn. After medical evaluation from paramedics and the MD, it was recommended pt be further evaluated at hospital. Pt transported to hospital, wife drove personal vehicle in stable condition.
35 2021-04-13 weakness, feeling cold From 12:30PM to 8:30PM i felt okay. From 9PM, I started feeling cold, got headache, felt weak and ey... Read more
From 12:30PM to 8:30PM i felt okay. From 9PM, I started feeling cold, got headache, felt weak and eyes started getting heavy at 3AM - I woke up because of severe headache. I also felt cold, and believe I had fever. at 6AM onwards - I felt very weak that I could barely get up in bed. Headache was severe. Still got fever. I lost my sense of smell and taste. 1:30PM - I took ibuprofen. 5PM - Fever was gone, but there was headache and weakness. No sense of smell and taste. 7PM - Felt better, headache was less. little sense of smell and taste. still felt weak and dizzy. 7AM - Felt weak, dizzy. not much headache. 11:45AM - still feeling weak and dizzy.
35 2021-04-13 cold sweat Participant sitting in Vaccination monitoring area; est. 10 min post first dose Pfizer vaccination (... Read more
Participant sitting in Vaccination monitoring area; est. 10 min post first dose Pfizer vaccination (Lot# ER 8733). Participant's mother voiced "son c/o feeling lightheaded." 1552 Assessed while sitting and participant is clammy, pale with c/o of feeling faint and stomach bothering him". 1555 Noted allergy of PCN with medical hx of reflux, autism and some anxiousness per mother; Attempted to moved to monitoring cot but participant voiced inability to stand up. 1557 EMS called to site. 1559 BP 118/72, P 90, O2 sat 98%; sitting. 1602 Participant provided sips of H2O; swallows without diff. Skin remains clammy / pale with no resp distress; O2 sat 99% / P 70. 1604 BP 124/68 - P 70 - Sat 99% with decrease paleness. 1605 Fire Rescue team arrives. Participant voiced "Feeling better with no feeling of faintness / lightheadedness". Noted decrease in clamminess. 1607 Mom remains at participant side and voiced son "son looks / feels better. 1608 P - 64, O2 SAT 99% with participant requesting to stand up at time. 1611 Paramedics arrived with assessment of participant. 1615 Participant ambulated on his own without difficulty; paramedics monitoring. 1618 Participant's mother declines EMS transport for further evaluation; will transport participant back home and monitor. At time EMS provided education on s/s monitoring and 911 follow up then departed scene. 1821 Participant and mother denies any continued complaints; noted pink / dry skin / P 70 / Sat 98%. Participant voiced he's "just hungry now"; mother shared both will stop and eat before traveling home. 1621 Discharged from site - mother and participant ambulated to private car with assist of Nurse without c/o or incident. Reminded to eat, drink and let PCP know about events post vaccination. *Vaccine exp. date 7/2021
35 2021-04-13 tingling, migraine One day after receiving my second vaccine, I started to get a tingling feeling on my nose and left c... Read more
One day after receiving my second vaccine, I started to get a tingling feeling on my nose and left cheek, near my sinuses. It would occasionally lightly burn. This persisted for a couple of days, then slightly improved. It never completely went away, and in the past day I have noticed it moving more to my head where I am having migraine like headaches behind my left eye.
35 2021-04-16 migraine Headache a couple hours ago. Took acetaminophen plus caffeine (generic Excedrin) Migraine and nause... Read more
Headache a couple hours ago. Took acetaminophen plus caffeine (generic Excedrin) Migraine and nausea now.
35 2021-04-16 pain in extremity Head ache, fatigue, left arm soreness (injection site), some congestion and occasional cough.
35 2021-04-17 flushing Syncope, Flushing/sweating. BP 116/77 HR 90 O2 Sat 95%. Patient stable and released from vaccinati... Read more
Syncope, Flushing/sweating. BP 116/77 HR 90 O2 Sat 95%. Patient stable and released from vaccination site
35 2021-04-18 weakness Chills started 8 hours after vaccination. Lasted 1 day. Muscle aches started 8 hours after vaccinati... Read more
Chills started 8 hours after vaccination. Lasted 1 day. Muscle aches started 8 hours after vaccination. Lasted 2 days. Weakness started 8 hours after vaccination. Lasted 2 days. Nausea started 14 hours after vaccination. Lasted 20 minutes. Fever started 10 hours after vaccination. Lasted several hours.
35 2021-04-18 burning sensation, feeling hot About 5 minutes after vaccination patient reported "not feeling well." Upon questioning he said his ... Read more
About 5 minutes after vaccination patient reported "not feeling well." Upon questioning he said his chest felt tight and he was having trouble breathing and requested his inhaler. Jail nurse brought his inhaler and listened to his lungs with a stethoscope. She reported that his lungs sounded clear bilaterally. Pt reported that using his inhaler helped his breathing and made his chest feel better. He also complained that his legs and head were "burning." When asked to elaborate, he said it felt hot and like he was experiencing pressure but not pain. His legs and face were expected skin color, dry, and without any raised or itchy patches. Pt was able to speak coherently and without difficulty throughout, and muscle tone was strong during entire reaction. Nurses remained with pt for approximately 35 minutes post vaccination. Epi was prepared but not administered. About 30 minutes after vaccination patient reported feeling better and was breathing smoothly.
35 2021-04-19 facial paralysis, bell's palsy Received dose 1 on Wednesday, by Friday night and Saturday I noticed fatigue in my facial muscles. B... Read more
Received dose 1 on Wednesday, by Friday night and Saturday I noticed fatigue in my facial muscles. By Sunday and Monday the left side of my face was paralyzed. Monday evening I was diagnosed with Bell's Palsy. Was prescribed Valtrex and Prednisone. No tick exposure or herpes diagnosis.
35 2021-04-19 numbness, tingling R side facial numbness and tingling occurred 30 mins after shot. Headache and pressure on right side... Read more
R side facial numbness and tingling occurred 30 mins after shot. Headache and pressure on right side of head, vitals signs normal. Right side of neck was tender. pt kept complaining symptoms were getting worse verses better so he wanted to go to the ED to be check out. EMS called.
35 2021-04-19 pain in extremity Small growth between testicles and butt. Slightly painful to touch. No treatment attempted yet.
35 2021-04-19 pain in extremity left calf pain , swelling and redness, patient reports stating one week prior to being seen in the c... Read more
left calf pain , swelling and redness, patient reports stating one week prior to being seen in the clinic on 19April2021, Patient was diagnosed with acute Embolism and Thrombosis of left popliteal Vein and started on Eliquis
35 2021-04-21 feeling hot Patient experienced a vasovagal reaction after vaccination. The patient reported feeling hot, sweaty... Read more
Patient experienced a vasovagal reaction after vaccination. The patient reported feeling hot, sweaty, dizzy, and nauseous about 5 minutes after vaccination. The patient was brought to the floor and provided with water and ice packs to use as cold compresses. The patient never fully lost consciousness and recovered from the event fully after about 10 minutes. He was able to leave the clinic after observation and there was no need for emergency medical services. Afterward, the patient reported a history of vasovagal reactions post vaccination.
35 2021-04-21 migraine Severe migraine for 2 days
35 2021-04-22 weakness, feeling cold, flushing, unresponsive to stimuli Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
35 2021-04-22 weakness On Day 1 of second dose 4/21 - Felt weakness and light-headed with slight muscle pain near the site... Read more
On Day 1 of second dose 4/21 - Felt weakness and light-headed with slight muscle pain near the site On Day 2 - 4/22 - Severe muscle pain full-body, head ache and low energy On Day 3 0 4/23 - Reduced muscle pain through out body, Head ache consistent, and now developed swollen lymph node on right side with pain felt in right ear and throat when swallowing
35 2021-04-22 burning sensation Client received 2nd dose COVID vaccine @ 12:00pm, complained of feeling burning sensation in chest a... Read more
Client received 2nd dose COVID vaccine @ 12:00pm, complained of feeling burning sensation in chest and lower back, with pressure in head @ 12:02pm. Client placed in chair, vital signs stable. Burning sensation in chest and lower back resolved at 12:09pm, head pressure lessened. Client left for home @ 12:34pm, with headache, advised to follow up with primary care if symptoms not resolved at home or worsen.
35 2021-04-23 seizure, muscle spasms A few minutes after vaccine administration , while the patient was sitting in the waiting area for o... Read more
A few minutes after vaccine administration , while the patient was sitting in the waiting area for observation, Patient lost consciousness and started convulsing/ spasms. RPh ran outside to attend to patient. Pt's eyes were rolled back and looked very pale. RPh asked staff to call 911 while attending to patient. Patient came to after about 30 seconds- 1 minute and was scared and confused. RPh calmed him down and took his BP. BP and HR was normal. Paramedics arrived shortly after and retook patient's vitals and made sure he was ok before leaving. There were no signs of anaphylaxis and paramedics think it was anxiety- related. Advised patient to have 2nd dose ok'd by MD and if yes, get it at a clinical setting.
35 2021-04-24 tingling, discomfort I had blacked out or passed out while driving; Shortly afterwards while driving I suddenly started t... Read more
I had blacked out or passed out while driving; Shortly afterwards while driving I suddenly started to not feel well.; Horrible dry, metallic taste in my mouth; Horrible dry, metallic taste in my mouth; VERY dizzy; My whole body started to tingle and I knew I needed to pull over as fast as possible; I feel very "off/extremely upset; This is a spontaneous report from a contactable consumer. This 35-year-old male consumer (patient) reported for himself. A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8729) via an unspecified route of administration in left arm on 08Apr2021 11:00 as SINGLE DOSE for COVID-19 immunization. Medical history was 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. The patient had no allergy to medications, food or other product. The patient receives other medication in two weeks include probiotics. After patient received first dose and waited 15 minutes as directed before leaving. He felt fine at this point. Shortly afterwards while driving I suddenly started to not feel well. Horrible dry, metallic taste in my mouth and started getting VERY dizzy. My whole body started to tingle and I knew I needed to pull over as fast as possible. I turned my signal on to turn right onto a side road and the next thing I know, I woke up in the woods. I had blacked out or passed out while driving and trying to pull off to safety. I was blacked out for at least 15 minutes. Now I feel very "off" and not myself. My car is damaged, and I don't have the means to get it fixed. I'm extremely upset. Adverse events start time: 01:30 AM. Patient didn't received treatment for the events. The clinical outcome is not recovering.
35 2021-04-24 tremor Patient complained of Light headedness, nausea, and tremor. These symptoms would come in waves ove... Read more
Patient complained of Light headedness, nausea, and tremor. These symptoms would come in waves over one and half hour. At 1:25pm BP was 168/91 and HR 108. He stated that symptoms had stopped at 2:45 at which time BP was 142/93 and HR 95
35 2021-04-25 pain in extremity When mixed, vial was only mixed with 1mL of diluent and 1 dose was given to patient. No other doses ... Read more
When mixed, vial was only mixed with 1mL of diluent and 1 dose was given to patient. No other doses were given from vial. Patient was made aware. Patient was followed up with on 4/25 at 4:30pm and no issues reported at the time. Also called patient on 4/26 at 10am and patient stated he was having a low-grade fever and sore arm.
35 2021-04-25 tingling, numbness The morning after my shot my right foot was numb and tingly. Almost like it was asleep, except it w... Read more
The morning after my shot my right foot was numb and tingly. Almost like it was asleep, except it was pretty severe and would not correct itself. I rated the numbness to be a 6, I could still feel things but they felt weird. The more I moved it or stood up to try and wake my foot up, the worse it became.
35 2021-04-26 feeling hot Tennitus in left ear/ears feel like they have fluid in them. Tennitis got worse and now have in both... Read more
Tennitus in left ear/ears feel like they have fluid in them. Tennitis got worse and now have in both ears; Muscle aches in neck/ shoulders; headaches; Warm feeling in ears.; Tired; brain fog; ear pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (Pfizer, lot number: EN6207) first dose on 04Apr2021 11:00 AM on left arm at single dose for COVID-19 immunisation. Medical history included Childhood asthma. Allergies to cats and dust. Concomitant medications were none. No other vaccine in four weeks. No Other medications in two weeks. The patient previously took Ibuprofen and experienced allergy. Day after getting vaccine (05Apr2021 04:00 PM) started to get tinnitus in left ear. Muscle aches in neck/ shoulders headaches mild vertigo. Warm feeling in ears. Tinnitis got worse and now have in both ears. Also ears feel like they have fluid in them. Some minor ear pain. Tired feeling and brain fog. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The outcome of the events was not recovered. No treatment for events. No Covid prior vaccination. No Covid tested post vaccination.
35 2021-04-26 muscle spasms Ongoing diarrhea, cramping, stomach pain, gas, mucus in stool.
35 2021-04-26 muscle spasms Chills, Sweats, Cramps night of vaccine and SOB
35 2021-04-27 weakness, pain in extremity fainted; weak; tired; dizziness, light headed; nausea; soreness and aches in upper legs; ear pain; s... Read more
fainted; weak; tired; dizziness, light headed; nausea; soreness and aches in upper legs; ear pain; swollen throat; joint pain; fever 101; chills; shortness of breath; elevated heart rate; sinus drainage; entire body pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 05Apr2021 at 09:00 (Batch/Lot Number: ER8734) at 35-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient medical history was not reported. It was unknown if the patient had COVID prior to the vaccination. There were no concomitant medications. On 09Apr2021 (as reported), the patient experienced: fainted (medically significant; also reported as 4 days after vaccine), weak (non-serious; also reported as 1-2 days after vaccine), tired (non-serious; also reported as 1-2 days after vaccine), dizziness, light headed (non-serious; also reported as 4 days after vaccine/ 7 days after vaccine), nausea (non-serious; also reported as 4 days after vaccine), soreness and aches in upper legs (non-serious; also reported as 4-7 days after vaccine), sinus drainage (non-serious; also reported as 4-7 days after vaccine), ear pain (non-serious; also reported as 4-7 days after vaccine), swollen throat (non-serious; also reported as 4-7 days after vaccine), joint pain (non-serious; also reported as 4-7 days after vaccine), fever 101 (non-serious; also reported as 7 days after vaccine), chills (non-serious; also reported as 7 days after vaccine), entire body pain (non-serious; also reported as 7 days after vaccine) shortness of breath (non-serious; also reported as 7 days after vaccine), and elevated heart rate (non-serious; also reported as 7 days after vaccine). The patient underwent lab tests and procedures which included body temperature: 101 on 09Apr2021, heart rate: 118-125 beats per minute (bpm) on 09Apr2021. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
35 2021-04-27 nerve pain, muscle twitching passed out; black out; tense nerve feelings/nerve twitching; tense nerve feelings/nerve twitching; t... Read more
passed out; black out; tense nerve feelings/nerve twitching; tense nerve feelings/nerve twitching; typical body aches or pain; This is a spontaneous report from a contactable consumer (patient). This 35- year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 12Apr2021 at 09:30 am (at the age of 35-years-old) as a single dose for COVID-19 vaccination, in left arm. The facility where COVID-19 vaccine was administered was a hospital. No known allergies. Patient has no relevant medical history. States: I live a healthy lifestyle diet, exercise, proper rest. 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. On 12Apr2021 10:00 am, the patient stated: I passed out and or blacked out on my drive home from the hospital. I was careful to follow the 15minute wait period before I left the hospital and was ok at that point. I had tense nerve feelings came over me as it grew so strong, I was forced to try and get my car on an off ramp to leave the highway I was on. I thankfully did not get any real injuries to my body as I spun and landed on the side of the road in the grass area. However, this experience was horrifying to say the least. I had a delayed reaction to this vaccine, other than this one incident, I really only had the typical body aches or pain for 24 hours and a bit of nerve twitching. I will not mark this as a risk of death, because it was my driving a car that risked my safety not the vaccine, however, the vaccine did cause the black out. The clinical outcome of the events was recovered. The patient was not tested for COVID-19 after the vaccination. Information about the Lot/batch number has been requested.
35 2021-04-27 pain in extremity Dose administered at 2:15PM. SORE ARM began same day, 6 hrs after dose administration. The next da... Read more
Dose administered at 2:15PM. SORE ARM began same day, 6 hrs after dose administration. The next day at 9:00 AM (19 hours after dose), patient experienced GENERAL CONFUSION/COGNITIVE REDUCTION, which lasted until 10:00 PM that day. At 11:00 AM day after (21 hours after dose administration), patient began experiencing LIGHT DIZZINESS which faded overnight.
35 2021-04-27 tingling Patient has been experiencing tingling of forearms/hands and lower legs/feet since 1 week after his ... Read more
Patient has been experiencing tingling of forearms/hands and lower legs/feet since 1 week after his first dose of the Pfizer vaccine
35 2021-04-29 pain in extremity Soreness at injection site Full arm pain of injection arm Body aches muscular and joint pain through... Read more
Soreness at injection site Full arm pain of injection arm Body aches muscular and joint pain throughout body Nausea
35 2021-04-29 seizure Patient came for 1st dose COVID-19 vaccine today. Patient denied having any vaccine reaction prior t... Read more
Patient came for 1st dose COVID-19 vaccine today. Patient denied having any vaccine reaction prior to today. Patient briefly convulsed and passed out post vaccination. Reaction was immediately and woke up a few seconds shortly after his name was called a couple times by the vaccinator. Patient admitted that he was very nervous and scared of needle, but denied ever experience fainting and convulsing. Patient was instructed to sit in the pharmacy for 30 minutes for observation. He rejected our offer to call EMT/Paramedics and for someone else to pick him up instead of driving himself. Patient received 4 cups of water from pharmacy. When he left at 30 minute mark, he was stable.
35 2021-04-30 weakness After 2nd dose of COVID19 vaccine (taken 3 weeks after first dose) I had a feeling of a mild fever/c... Read more
After 2nd dose of COVID19 vaccine (taken 3 weeks after first dose) I had a feeling of a mild fever/chills and low energy and body aches about 12 hours after the injection. However I also begin getting a lot of pain and tightness around my right rib cage intercostal muscle area and lower back (QL area to Lats). This made it harder to breath and hurt while I laid down to sleep. It also hurt to take a deep breath/cough/laugh etc. This lasted until Thursday night (4/29/21) when the same kind of pain moved over to my left side. The past 2 days it has become quite intense though making it impossible to sleep on my back last night (I had to sit upright to avoid intense pain) and painful to even walk. It still hurts in my left rib cage at rest (feels more like a dull ache and stiff), but intensifies if I try to expand my lungs with breathing or lie down or move in any way. Mainly intercostal area around the rib cage and the back around my lung. Thought I might have to go to the emergency room last night it was so bad.
35 2021-04-30 flushing, weakness, unresponsive to stimuli, tremor Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Di... Read more
Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Urinated in the event of fainting-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe
35 2021-04-30 flushing First vaccine, no major symptoms (04/09/2021) besides sore arm and flush feeling for ~1 hour around ... Read more
First vaccine, no major symptoms (04/09/2021) besides sore arm and flush feeling for ~1 hour around 7 hours after vaccine issued. Second vaccine (04/29/2021), slight headache after about 6 hours?woke up at 2:30am (11 hours after second vaccine) with flush feeling/light sweating but no fever. Triggered my vasovagal syncope (had this happen with other vaccines before so no big deal) to have a heavier heartbeat (about 10-20bpm higher than normal) for about 2 hours. Insomnia until about 6am. Next day 4/30 minor soreness, fatigue, soreness at injection site and ?blah? feeling with headache. 5/1/2021: woke up feeling great, other than soreness in my left arm and armpit area. By noon 5/1 most soreness gone with little to no other symptoms?
35 2021-04-30 muscle spasms I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fev... Read more
I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Right on 25Jan2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation. Medical history included was none. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks after receiving COVID vaccine. The patient had no history of COVID prior to vaccination and did not test post vaccination. The patient also stated that on 15Feb2021 at 10:00 PM, he had severe chills, fever and muscle cramps overnight. He was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours (on 16Feb2021), the fever broke and returned to 97F. The patient stated that on 15Feb2021 at 10:15 AM, about 30-45 minutes after vaccination, he experienced elevated heart rate. His Apple Watch alerted him asking if he was working out, and upon checking his heart rate, it was oscillating between 85 - 110 BPM. After about an hour, his heart rate dropped back down. The patient did not receive any treatment for the events. The outcome of the events chills, fever and muscle cramps was recovered on unspecified date in 2021. The outcome of the event heart rate increased was recovering.
35 2021-05-01 weakness, cold sweat Approximately 8 hours after second vaccination patient had chills, fever, muscle soreness and fatigu... Read more
Approximately 8 hours after second vaccination patient had chills, fever, muscle soreness and fatigue. Patient also developed an acute headache that evening and was unable to sleep more than a few hours that night. Patient administered 800 mg of ibuprofen to relieve headache and also drank lots of water. Patient also awoke multiple times in cold sweat and had to change clothing due to dampness. The following day Patient continued to have the muscle soreness and fatigue as well as loss of appetite. patient did force himself to eat and continued to drink lots of water with occasional Gatorade. Began to feel better mid-afternoon, however by 8 p.m. fever and chills were setting in again. Patient then administered one dose of NyQuil and took an early bed. Patient slept well through the night and woke up the next day and is able to resume regular activity, although at substantially lower energy levels. By 8 p.m. that night, chills, fever and headache was returning however patient attempted to sleep it off. This resulted in highly interrupted sleep and patient resorted to 800 mg of ibuprofen to stop headache again. Patient woke multiple times through the night in a cold sweats and had to change clothing to return to sleep. Patient continued through the day to rest an attempt to recuperate. That brings us to the present moment, where patient is currently experiencing fatigue and muscle soreness.
35 2021-05-01 feeling hot Started with fatigue, difficulty breathing. Has continued for days. Also suffering from nausea, vomi... Read more
Started with fatigue, difficulty breathing. Has continued for days. Also suffering from nausea, vomiting, diarrhea achy body, feeling hot, shortness of breath treated with inhaler.
35 2021-05-01 flushing Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhau... Read more
Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Additional Details: Pt's temp at time of vaccine was 99, dropped to 94-95 during acute distress. Pt had eaten breakfast but was doing manual labor before getting vaccinated. He was very hungry after he recovered from acute distress. BP had dropped significantly but did return to normal ~80/120 after recovering. All other sypmtoms resolved after several minutes except for injection site swelling
35 2021-05-01 pain in extremity, numbness Left side of my face felt numb for a full day after, starting around 2 pm. 2 days later I still feel... Read more
Left side of my face felt numb for a full day after, starting around 2 pm. 2 days later I still feel a bit of numbness around the top of my left cheek and around my eye that comes and goes. Also strange pains in my left thigh on day after, thats now moved to my right leg. And a few weird pains in my back and very still neck on the left side. Also a bit of pointed pain in a single location on the back left side of my skull.
35 2021-05-02 feeling cold, feeling hot, migraine Short visual effect of a kaleidoscope half-ring for about 30 minutes. Extreme cold feeling/shivers d... Read more
Short visual effect of a kaleidoscope half-ring for about 30 minutes. Extreme cold feeling/shivers during night for around 3 hours followed by feeling of being extremely hot for about 2 more hours. Bad migraine lasted one day. Feeling of unbalanced and needing assistance to walk for about 2 hours after waking up next morning. Head felt stuffed up similar to sinus pressure, but no other sinus symptoms.
35 2021-05-02 feeling hot, unresponsive to stimuli Patient told me that he gets dizzy after immunizations. I told him that I would keep him seated afte... Read more
Patient told me that he gets dizzy after immunizations. I told him that I would keep him seated after until he felt ok, his wife was with him and I told her that if he started feeling bad to let me know as I went back into the pharmacy. About 5 minutes after his immunization he said he didn't feel well. I went out to check on him he said he was hot and then he lost consciousness. His wife and I were not able to wake him, 911 was called and I grabbed the Epipen 0.3mg and gave him 1 dose in the left thigh. Shortly after he started to respond. Once awake he began vomiting and still complained of being very hot. His wife splashed water on his face and we kept talking to him until EMS arrived about 5 minutes after the Call. EMS checked him out, he refused to go to the hospital and refused them to take him to his car when he felt better. He walked out on his own after about another 20 minutes with his wife. I called to check on his around 4pm and he said that he was feeling ok.
35 2021-05-02 flushing Flushing/sweating, dizziness, nausea. Stable, released from vaccination site.
35 2021-05-02 pain in extremity Immediately for 36 hours - left arm pain - head fog - thirsty - fatigued In addition: my 3 year old... Read more
Immediately for 36 hours - left arm pain - head fog - thirsty - fatigued In addition: my 3 year old daughter developed roseola 4 days after I received the shot. I did not mention my vaccine, and her pediatrician informed us that roseola is a herpes virus and it is often a virus that sheds from parents and often lays dormant in parents. It is my belief that the vaccine caused me to shed this virus to her.
35 2021-05-03 numbness Noticeable numbness in right hand beginning ~2 hours after injection at 11:30 on 4/24, ongoing after... Read more
Noticeable numbness in right hand beginning ~2 hours after injection at 11:30 on 4/24, ongoing after 10 days. Fever spiking above 101°F, chills, fatigue beginning from 22:30 on 4/24, 9:24 on 4/26. Headache, onset accompanying fever, which lasted about another 1-2 days after fever.
35 2021-05-03 numbness 35 year old male without a significant health history, who had his second dose of the Pfizer vaccine... Read more
35 year old male without a significant health history, who had his second dose of the Pfizer vaccine 4 days prior to admit on 4/30/2021. Since his second vaccine dose, he started having generalized chest/abdominal aching, chills, body aches, nausea/vomiting. On the day of admission, he awoke with numbness in his right and left upper extremity. In the ED, his ECG showed NSR with anterior and inferior ST elevation. Troponin elevated to 3.99, trended down. Echo normal. Cardiac MRI suggested myocarditis. He was started on colchicine 0.6 mg BID with resolution of his symptoms.
35 2021-05-03 unresponsive to stimuli While waiting 15 minutes after vaccination, patient approached window stating to Pharmacy Techni... Read more
While waiting 15 minutes after vaccination, patient approached window stating to Pharmacy Technician he felt light headed, dizzy. Technician went to alert Pharmacist and patient collapsed to the floor. 911 was called. Patient was breathing but unresponsive and pale. Pharmacist administered Epinephrine o.3mg IM. Patient gradually became alert and was moved to chair with feet elevated and Blood Pressure of 129/74 and pulse 65. Water was given and EMTs arrived and took over assessment.
35 2021-05-04 numbness, tingling Pfizer-BioNTech COVID-19 Vaccine EUA: three days after vaccination patient presents to emergency dep... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: three days after vaccination patient presents to emergency department (ED) reporting sudden onset severe chest pain, emesis, numbness/tingling of arms, and nausea. Initial vital signs: pulse = 90 beats per minute, blood pressure 142/100 mmHg, oxygen saturation 95% on room air. Patient admitted for management of NSTEMI: differential includes myocarditis.
35 2021-05-04 pain in extremity Pt states he received second dose of Pfizer COVID-19 vaccine on 4/27/21. Reports on 4/29/21 his ring... Read more
Pt states he received second dose of Pfizer COVID-19 vaccine on 4/27/21. Reports on 4/29/21 his ring and pinky finger of his left hand became painful. States if he rests them for a while, like during sleep, when he moves them again, the pain is rated 9/10. States with movement throughout the day, pain is rated 2-3/10. Reports he has not taken any medication to help the pain, denies significant impact on ADLs, but states that typing is difficult and painful and notices pain with grasping. Has not sought medical care. Discussed when to seek evaluation. States understanding.
35 2021-05-05 pain in extremity, weakness 100.1F low grade fever, muscle soreness, chills, heavy eyes, headache, weakness, sore arm a day afte... Read more
100.1F low grade fever, muscle soreness, chills, heavy eyes, headache, weakness, sore arm a day after second Pfizer dose. No symptoms after first dose.
35 2021-05-06 pain in extremity soreness in right arm, chest pain, left ankle pain
35 2021-05-09 flushing Flushing /sweating, dizziness. Pt has a fear of needles (info not disclosed at the time of vaccinat... Read more
Flushing /sweating, dizziness. Pt has a fear of needles (info not disclosed at the time of vaccination). VSS. Patient stable and released from vaccination site.
35 2021-05-09 pain in extremity Sore arm for 24 hours
35 2021-05-10 cold sweat, involuntary muscle movements My condition rapidly went down the hill right before bed time. I woke up because of me screaming my ... Read more
My condition rapidly went down the hill right before bed time. I woke up because of me screaming my wife's name. I tried to get to my phone but my hands were out control for roughly 10 seconds - i never experienced such thing in my life (i will try to describe it - i could move them around shoulder but the rest looked like tentacles - no control over fingers too) . Around 5 seconds into trying to grab my phone i was completely awoken and realized that i covered in cold sweat, my heart rate is extremely high (when i returned control over my limbs i checked and it was >120, when i sleep i usually have around 45). Based on my smart watches my heart rate went all the way up to 160 at the moment when i woke up. Heart rate went down to ~80 and after 20-30 minutes or measuring everything possible (blood pressure, heart rate, oxygen level, etc) we decided not to call 911. The rest of the night was ok'ish - in AM i checked smartwatch data and my average heart rate was 60 which is 10-15 above normal. Next morning welcomed me with moderate fever (37.5C), joints pain (also never experienced at such scale - literally entire body), headache and bunch of other annoying things (including one impacting vision - until lunch time everything had higher contrast). Two days after i completely recovered.
35 2021-05-10 migraine severe Migraine, minor Fatigue, minor Muscle aches symptoms onset around 08:00 pm, 05/06/2021, most ... Read more
severe Migraine, minor Fatigue, minor Muscle aches symptoms onset around 08:00 pm, 05/06/2021, most severe overnight, and continues into the afternoon the following day. Symptoms slowly lessened in the evening the following day and recovered around 08:00 pm, 05/07/2021.
35 2021-05-11 weakness, pain in extremity, burning sensation I've got the second dose of Pfizer Covid vaccine on 5/6/21 evening. About a day and a half later on ... Read more
I've got the second dose of Pfizer Covid vaccine on 5/6/21 evening. About a day and a half later on 5/8/21 around 1 am, my symptoms started. It has been 4 days and i am still having side effects. First it was pain the arm them throughout my body. Later my bones were all in pain while being very weak. Last 2 days, the pain has subdued by my entire body is burning up from the inside. Currently, in still weak, tired, but mainly feeling of burning inside my body. The vaccination site which is my left arm still feels kinda sore and hot. I have been taking 2 Tylenol 500mg tablets every 6 hours, vitamin c every day, vitamin d 5000ui every day, and ibuprofen 800mg twice a day only for 2 days.
35 2021-05-11 numbness Patient stated he started feeling bad the day after the vaccine and his Left Big Toe at the tip (toe... Read more
Patient stated he started feeling bad the day after the vaccine and his Left Big Toe at the tip (toe nail area) became numb. He stated it has not resolved.
35 2021-05-12 pain in extremity Symptoms started approximately 14 hours post-vaccination. Day 1 symptoms: - Fever (<= 101.0 degre... Read more
Symptoms started approximately 14 hours post-vaccination. Day 1 symptoms: - Fever (<= 101.0 degrees F) - Chills - Headache - Fatigue/tiredness - Vomiting (one time exactly 24 hours post onset of symptoms) Days 2 - 5 symptoms: - Severe pain/tightness and fatigue feeling in both arms, shoulder blades, and chest. This has slowly improved over days 2 through 5. - Nausea associated with the pain/tightness noted above - Coughing (no phlegm) - Vomiting (one more time on day 2 exactly 24 hours after the first vomiting episode) - Fever and chills (both resolved by days 2-3) Treatments: - 500 mg Tylenol was used to treat fever and pain during the first several days. Fever was well controlled, but pain was only partially controlled - On days 3+ Advil was used for pain relief and it was effective - Alka Seltzer Gold was used to treat nausea as necessary. It was not particularly effective as the nausea seemed linked to the severity of the pain. When the pain eased, the nausea did as well. Outcomes: - Symptoms have slowly improved over the 5 days post 2nd dose vaccination. Advil has been discontinued since the afternoon of day 4. No fever is present and the pain is now only mild.
35 2021-05-12 tingling Patient left the observation room 15 minutes after being vaccinated. He came back and stated he is f... Read more
Patient left the observation room 15 minutes after being vaccinated. He came back and stated he is feeling dizzy, high and tingling in feet and legs. Per patient he has history of smoking and anxiety , but no other health problem or allergic reactions to food or medications. Checked patients vitals sign after he was lying down . BP 121/73, HR 75, O2 sat 96%, pain 0/10. Patient was given a bottle of water after stating he did not have any fluid since morning. Per patient he had breakfast before coming to the clinic. No signs of hypoglycemia noted at this time. Patient was asked to to stay 15 more minutes in the observation room to monitor him closely. Patient stated he is feeling better. Did not notified the paramedic since patient was feeling better with stable vitals signs . Patient was educated on s/s of anaphylactic reaction and when he needs to ask for help before he left .
35 2021-05-13 discomfort, feeling hot Nausea, discomfort, became very hot. Visuals that were almost hallucinogenic. Light colors were glow... Read more
Nausea, discomfort, became very hot. Visuals that were almost hallucinogenic. Light colors were glowing like neon. Paterns were very vivid and intense. Blurred vision. Dizziness. Lasted for about 10 minutes. Started 5 minutes after shot. Reported it to nurses after symptoms subsided. They gave me some water and I stuck around to be monitored. Everything was fine until the 4th day when I got a sinus infection which lasted for a week. Got a Covid test just in case on that Sunday. It was negative.
35 2021-05-13 numbness, tingling Tingling and numbness at injection side and spreading to arm and hand of same side. Strong for 1/2 h... Read more
Tingling and numbness at injection side and spreading to arm and hand of same side. Strong for 1/2 hour but continued in and off ( more mildly) for several days
35 2021-05-13 pain in extremity light dizziness; cognitive reduction ("covid brain fog"); general confusion; sore arm; This is a spo... Read more
light dizziness; cognitive reduction ("covid brain fog"); general confusion; sore arm; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left arm on 26Apr2021 at 14:15 (Lot Number: ER8735) as SINGLE DOSE for COVID-19 immunization in pharmacy or drug store. The patient's medical history was not reported. The patient previously took Cefzil and experienced allergies. Concomitant medication included loratadine (LORATADINE 10 mg) at a dose of 10 mg daily from an unspecified date for an unknown indication. The 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), via an unspecified route, administered in left arm on 05Apr2021 at 12:00 (Lot Number: EW0150) as SINGLE DOSE for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021 at 20:15, the patient experienced sore arm. On 27Apr2021 at 09:00, the patient was having general confusion/cognitive reduction ("COVID brain fog"), and on the same day at 11:00, the patient felt light dizziness. No corrective measure was received by the patient for the reported events. The outcome was reported as recovered in morning of 28Apr2021 for the reported events. No follow-up attempts are needed. No further information is expected.
35 2021-05-13 tremor, cold extremities PT WAS SITTING AT POST-VACCINATION AREA AND SUDDENLY FAINTED. PT FELLED OVER AND WAS SHAKING. HE REG... Read more
PT WAS SITTING AT POST-VACCINATION AREA AND SUDDENLY FAINTED. PT FELLED OVER AND WAS SHAKING. HE REGAINED CONSCIOUSNESS RIGHT AWAY WHEN HE HEARD SOMBODY CALLING HIM. HE SAID HIS HANDS WERE COLD
35 2021-05-13 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
35 2021-05-14 feeling hot Fever, Feeling hot and getting chills, skin painful to touch, neck pain, headache, dizziness, fatig... Read more
Fever, Feeling hot and getting chills, skin painful to touch, neck pain, headache, dizziness, fatigue, injection site pain, and flu-like symptoms.
35 2021-05-14 grand mal seizure Grand Mal seizure; Heart palpitations; This is a spontaneous report from a contactable consumer (pat... Read more
Grand Mal seizure; Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 28Apr2021 at 14:00 (lot number: EW0158) at single dose for COVID-19 immunization. The relevant medical history included epilepsy, childhood leukemia and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19), all from unspecified date. Concomitant medications included lamotrigine (LAMICTAL ODT). The patient experienced Grand Mal seizure and heart palpitations on 29Apr2021 at 18:00. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
35 2021-05-14 tingling, bell's palsy left eye tingling and not able to close with Left side mouth not able to close; left eye tingling an... Read more
left eye tingling and not able to close with Left side mouth not able to close; left eye tingling and not able to close with Left side mouth not able to close; loss of taste of left side of tongue; Bell's palsy symptoms; Cold with light sneezing; Cold with light sneezing; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737), dose 2 via an unspecified route of administration, administered in left arm on 06Apr2021 15:00 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) administered in left arm on 16Mar2021 18:30 for COVID-19 Immunization. Cold with light sneezing developed on 27Apr2021 and Bell's palsy symptoms developed from 28Apr2021 around night before bed (22:45). On 29Apr2021, left eye tingling and not able to close with Left side mouth not able to close and loss of taste of left side of tongue. Doctor diagnosed on 30Apr2021 that it is early stages of Bell's palsy could be due to vaccine or shingles. No symptoms of shingles. The patient did 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. The patient received treatment (Bell's Palsy along with Shingles) for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no COVID prior vaccination, no COVID tested post vaccination, no known allergies. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
35 2021-05-14 seizure According to my wife, 10 minutes post shot I had what appeared to be a mild seizure and lost conscio... Read more
According to my wife, 10 minutes post shot I had what appeared to be a mild seizure and lost consciousness for 1-2 minutes. Prior to that happening, I told her I felt light headed. She notified personnel while we were in the 15 min wait holding area and when I regained consciousness two EMTs were checking me out. They took my vitals, asked me questions and had me get out of the car and walk around. I was monitored for several minutes. It was recommended I visit a hospital or urgent care if I continued to feel unwell. My wife & I left the vaccine site and decided on the way home to go to the hospital just to ensure everything was all right. We went back home for about 30-60 minutes. During this time my heart rate continued to remain elevated and it felt like I had adrenaline coursing through my system. I attributed the feeling to recovering from passing out, but it did not dissipate. Upon arrival to the ER I began having trouble trying to breathe and chest pain. During the triage EKG it was discovered I was experiencing atrial fibrillation. I was given treatment, fluids and monitored for several hours before being released. Estimated time from receiving shot to being diagnosed with afib was approximately 2.5-3 hours.
35 2021-05-15 weakness, numbness The day of my first dose (January 23) I felt a bit numb in the head but thought it would be okay. Th... Read more
The day of my first dose (January 23) I felt a bit numb in the head but thought it would be okay. That did clear up. I was however very weak after the first dose but improved. By February 7, I had been feeling pulsations in my head and I checked that I had a BP over 200/100 and went to the ER. I was given a low dose amplodipine however my primary care doctor checked my urine and found very high proteinuria. Eventually I followed up with a nephrologist after being given an urgent referral and was diagnosed with membrane nephropathy due to high PLA2R levels. My proteinuria was 13 g/day (severe) and I had very high cholesterol and low serum albumin (2.5 mg/dl). He mentioned that the vaccine has unmasked it in several people. I have received treatment of 10 mg Lisinopril, 20 mg Simvastatin, 81 mg aspirin and have received my first infusion of 1 g Rituximab and will follow with a second infusion 2 weeks later.
35 2021-05-16 cold sweat 4/16/21 Patient presents to ED w/chest pain. he was found to be + for SARS-CoV-2. He was placed in o... Read more
4/16/21 Patient presents to ED w/chest pain. he was found to be + for SARS-CoV-2. He was placed in observation and was discharged to home the next day after IV hydration and lowering blood sugar. Chest and abdominal myalgias In context of COVID-19 infection, he has no additional symptoms of Covid. CPK is unremarkable Likely secondary to COVID Covid-19 Virus Infection Date of onset of symptoms: ?? Date of covid positive test: 4/16/2021 Symptoms: Myalgias, no fever, no GI or respiratory symptoms Special isolation precautions implemented: yes Oxygen requirements on admission: None Current oxygen requirements: None Medical therapy: not indicated
35 2021-05-18 weakness, feeling jittery Pt became weak and began to fall. Nurse lowered to ground. Fire department and other agency assisted... Read more
Pt became weak and began to fall. Nurse lowered to ground. Fire department and other agency assisted; Pt aroused and c/o feeling jittery. Blood sugar 105; Provided food from car which was cotton candy and peanut butter and crackers. Pt states feels much better but but knee and neck hurt. Small abrasions on lateral aspect of knee and 2 bruises over bony areas of knee. Area cleaned with alcohol and band aide applied. Neck has full ROM. No abrasions on head. Patient and wife instructed to go to PCP or ER after they leave. Wife states they will go to PCP, Pt released in stable condition.
35 2021-05-19 flushing Systemic: Abdominal Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Syst... Read more
Systemic: Abdominal Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
35 2021-05-19 pain in extremity General soreness around injection site. Sharp pain under left arm when performing any kind of stretc... Read more
General soreness around injection site. Sharp pain under left arm when performing any kind of stretch. No pain when arm is at rest. As of writing (9:30 am), pain upon stretching is milder, but still noticeable.
35 2021-05-19 pain in extremity back pain that shifted positions and was then in the left neck, shoulder and arm regions; back pain ... Read more
back pain that shifted positions and was then in the left neck, shoulder and arm regions; back pain that shifted positions and was then in the left neck, shoulder and arm regions; back pain that shifted positions and was then in the left neck, shoulder and arm regions; back pain that shifted positions and was then in the left neck, shoulder and arm regions; This is a spontaneous report from a contactable consumer (patient). This 35-year-old male 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 28Jan2021 (at 35-years of age) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included testosterone cipionate, vortioxetine hydrobromide (TRINTELLIX) and propranolol, all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number EK9231) on 06Jan2021 at 16:00 (at 35-years of age) for COVID-19 immunisation. The patient reported experiencing rapid onset of back pain that shifted positions and was then in the left neck, shoulder and arm regions on 04Feb2021 at 07:00, 7 days following the second shot. He reported he was referred by his primary care physician and physical therapist to a physiatrist specializing in spine/neck issues. It was unknown if treatment was received for the events. The clinical outcomes of back pain that shifted positions and was then in the left neck, shoulder and arm regions were not recovered. It was also reported that since vaccination, the patient had tested negative for COVID-19 via blood test on 15Feb2021. No follow-up attempts are needed; information about lot number cannot be obtained.
35 2021-05-20 weakness Worst headache of my life. Completely drained of all energy.
35 2021-05-20 weakness started as severe dizziness and weakness, chest pain was hospitalized once I got to the ER because m... Read more
started as severe dizziness and weakness, chest pain was hospitalized once I got to the ER because my heart was not working properly, after many test the found my heart was in heart failure with an output of 35% only, was in hospital for 5 days. Doctors couldn't see what caused such a sudden weakness of the heart, they did cardio path and arteries have zero blockage, they did ECO, and a EP Study. My heart now suffers from PVCs or arrhythmia and they are very irregular and frequent. Was given medicine to help the heart and control the PVCs, and discharged with wearing a safety vest, to follow up with the cardio doctors. Followed up with doctors and they have done an MRI which shows scarring of the heart. The doctor has determined that the diagnosis is myocardiatis. There is no proof this direct relation with the vaccine, however symptoms started soon after the vaccine in a healthy young man. Now I still have to go to another electrophysiologist to see what he can do to help alleviate the PVCs and continue to take the medication to see of the heart can improve. I could not work for a month, and still cannot resume normal activities because my heart is to weak to sustain it.
35 2021-05-20 pain in extremity Arm pain, diarrhea, stomach pain, and chills.
35 2021-05-23 numbness, sensory loss, tingling (Note: patient has reported incident to VAERS as well) Patient called to cancel second dose due to ... Read more
(Note: patient has reported incident to VAERS as well) Patient called to cancel second dose due to severe adverse reaction to first dose. Patient notified and is under the care of his primary physician, who has referred him to neurologist specialist. Pt reported severe pain at injection site (left deltoid) approximately one hour following shot. Approximately 4 to 5 hours after vaccination pt was observed by friend to have fainted, he appeared to be asleep and snoring for 3 minutes. Pt reported to have lost feeling in arm (shoulder down to fingers) for a period of time, which slowly has resolved. Currently he still has numbness in his fingers of left hand and has the sensation of pins and needles.
35 2021-05-23 pain in extremity, numbness muscle pain, fatigue, pain down hip to leg, knee down is numb
35 2021-05-24 migraine 24 hour Migraines
35 2021-05-25 tingling Shingles manifesting as parathesia and blisters on the right torso (upper back, side of chest, below... Read more
Shingles manifesting as parathesia and blisters on the right torso (upper back, side of chest, below rib cage)
35 2021-05-26 tingling pt got vaccination approximately and 1:00 pm. Pt. returned at 7:45 pm. Pt is panicking, states tha... Read more
pt got vaccination approximately and 1:00 pm. Pt. returned at 7:45 pm. Pt is panicking, states that he feels his hands are tingling and that he never felt this way before. I asked if he ever had that tingling before and he said yes. Pt. states that he has anxiety disorder. pt does not have hives, sob, but does appear nervous. Offered to call EMS in he felt that it was necessary, he stated "no," I'll just wait in my car. I told pt he was welcomed to stay and sit in the building and we would call EMS if necessary but he repeated he would wait in his car.
35 2021-05-26 seizure seizure at 3:30 in the morning. Partner discovered seizure activity awoken from sleeping. Last seizu... Read more
seizure at 3:30 in the morning. Partner discovered seizure activity awoken from sleeping. Last seizure activity was 2 years prior to event. No change in medications prior to immunization.
35 2021-05-27 cold sweat, tremor Patient had fainted after receiving the vaccine and when I came to saw him, he was back on the chair... Read more
Patient had fainted after receiving the vaccine and when I came to saw him, he was back on the chair. He said he felt faint. I asked if his breathing was alright, his sight and hearing was ok; he said everything was fine, but he still felt faint. Then I saw his eyes closing again and he slouched down on the chair and became unconscious. I helped him onto the ground, where he started shaking, so I rolled him onto his side. He felt clammy. It was a few seconds before he stopped shaking and opened his eyes again. I asked him to stay laying on the ground and asked him again regarding his breathing, hear rate, vision, how he felt. He asked if he passed out again and I told him yes and we're going to keep him on the ground until paramedics arrive. He said he felt better; his breathing and speech was fine, there wasn't any sound of shortness of breath, but he was sweating in cold sweats and he asked us to fan him. He said that he felt better and that he has a big phobia of needles, which his wife who was there, confirmed. He informed me that he's fainted several times at doctor's office and hospitals when they stick a needle in him. When the fire fighters arrived, they spoke to him prepared to get a EKG on him, to which he immediately told them that he doesn't want them to stick any needles in him and he became frightened that the EKG pads were needles. When paramedics came, they determined that they had to take him to the hospital because they said he wasn't able to stand up on his own without falling over and his heart rate was increasing.
35 2021-05-27 feeling cold Epstein Mono virus positive; freezing cold and could not get warm; Heat intolerance; Tongue discolor... Read more
Epstein Mono virus positive; freezing cold and could not get warm; Heat intolerance; Tongue discoloration; Sore throat; Lost 20 pounds; Swollen lymph nodes; Anxiety causing him to not sleep; constant pressure on his neck; he could barely hear; Trouble swallowing; Breathing was becoming a concern; Anxiety-like symptoms; Pain on right side of neck; Tightness in throat; Right ear plugged; Pretty severe chills; Swollen neck; General fatigue and malaise; General fatigue and malaise; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 21Jan2021 12:00 (at 35 years old) (Batch/Lot Number: EL9263) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing food allergy. The patient's concomitant medications were not reported. After receiving the Covid Vaccine on 21Jan2021, the caller has experienced a lot of adverse side effects that he's dealing with now almost 3 and a half months later. He has seen numerous doctors as well as specialists. He has a long list of symptoms that occurred at onset. What he is dealing with now is a swollen neck (onset date 21Jan2021), a sore throat (onset date 21Jan2021), tongue discoloration, and just general fatigue (onset date 21Jan2021) and malaise (onset date 21Jan2021). Prior to the shot he was physically healthy. He was running about 20 miles a week. Then he got the shot and his health declined significantly and he is still recovering. When this occurred, caller weighed 165 pounds, and now he weighs 145 pounds. He lost 20 pounds. These events happened after the first dose of the vaccine. He got his vaccine at around noon on 21Jan2021, and by that evening at around 2000 he had a tightness in his throat, felt like his right ear was plugged up, then had pain on the right side of his neck. It all coincided with the same side as the vaccine, which he had in his right arm. He also experienced some pretty severe chills. His throat still feels swollen, probably because of his swollen lymph nodes. Some days it is better and some days it is worse. It is causing constant pressure on his neck. He is not sure if he noticed the swollen lymph nodes the same day as the shot or shortly after.Patient does not currently have neck pain. He should probably mention it started probably a few weeks after the onset of his symptoms. He does not know when it went away. He was getting swollen lymph nodes on his left side as well, and his throat became sore on the left side as well. It went away maybe a few weeks ago. He is not sure when the swollen lymph nodes or the sore throat started. His right ear was plugged and then it affected his left ear and it got plugged up as well. It was to the point where he could barely hear. It was almost like an ear infection when it is completely plugged and there is pressure behind the ear drum. 2 weeks after his right side it started on the left side. It has subsided by this time, but it has not completely gone away, but it is not as bad. Patietnt had the chills for 3 weeks, but they weren't as severe as the first night. He was just freezing cold and could not get warm. After that night he was still having issues feeling warm and had to keep his bedroom at like 80 degrees constantly. It probably continued for about a month. He doesn't have chills now, however it evolved into more of a heat intolerance. Whenever he feels to warm he feels more tired and not well overall. It is really odd. It is more heat intolerance he feels is going on. After the first few months it started then he had the opposite. He had a problem getting warm, then after the first month he didn't tolerate heat too well. He is not sure when the tongue discoloration first started, but he noticed it about a month and a half ago. The general fatigue and malaise started at the beginning with everything else. He did not have the second dose of the vaccine. Caller believes the doctors ran a CBC. He had a complete panel done a few times and nothing concerning presented or stood out to the doctors. They did an ultrasound on the left side of his abdomen to make sure he had no spleen enlargement, and that came back normal. They ran thyroid panels and those came back normal. One thing that came back abnormal that explains more of this but the timing is odd with the vaccine is he came back positive for Mono. He started seeing an ENT specialist, and he believes that getting the vaccine could have caused his immune system to freak out considering his history with allergies. It could have caused the Epstein Mono virus already present to become reactivated. That was kind of his theory on why this could have occurred. All the events caused a visit to Emergency Room. He went to the ER about a week, exactly a week after he had the vaccine that day. He was having trouble swallowing (onset date 28Jan2021) as well as his breathing was becoming a concern (onset date 28Jan2021) for him. He also was just having what felt like anxiety-like symptoms (onset date 28Jan2021), and he has no history of anxiety. If he got the vaccine on 21Jan2021 then this happened around 28Jan2021. He did have another ER visit about a week after that one as well. He started to have severe symptoms similar to the first time he went. He is still having a little bit of an issue swallowing. He attributes that to the swelling in his lymph nodes and neck possibly affecting that. His breathing he does not have problems with so much now. He has more of a constant discomfort in his neck, though it is not affecting his breathing at this point. As far as general anxiety he still has that and it does cause issues. It is causing him to not sleep as a result. His swallowing is better. His breathing was the most severe of the symptoms. Maybe after the first month it began to become less of an issue. He couldn't say exactly when it went away. It probably went away as a result of the swelling subsiding. To be honest he is not sure. Doctors put the caller on numerous medications as well as a medicine that he continued with. He doesn't know if his anxiety is better as a result of the medicine helping or if it would be the same if he went off of it. He is not sure. He has had trouble sleeping since this all began. It has been a little better. It could be a result of the medicine that helped. He is really unsure if he was not on the medicine how it would be. Patient visited a Physician Office for all events.No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. The outcome of the events Throat tightness,Sensation of block in ear,Swallowing difficult,Anxiety, Sleep difficult,Hearing reduced was recovering; chills,Swollen lymph nodes,Neck pain,Sore throat was recovered; Tongue discoloration, heat intolerance,Fatigue,Malaise was not recovered; other events was unknown.
35 2021-05-27 pain in extremity Soreness in arm beginning the afternoon vaccine was administered and lasting approx 56 hours, fatig... Read more
Soreness in arm beginning the afternoon vaccine was administered and lasting approx 56 hours, fatigue beginning in the late afternoon and lasting approx 36 hours, urticaria developed bilaterally on the medial elbows beginning overnight Tuesday into Wednesday morning. The urticaria is now drying out and beginning to heal but is still present. No intervention was sought from a medical provider. It is mild and no treatment was needed.
35 2021-05-28 pain in extremity, numbness numbess in left arm, feet pain, headache severe back pain
35 2021-05-30 numbness, tingling A few hours after receiving my first dose, the tips of my fingers suddenly felt like they were being... Read more
A few hours after receiving my first dose, the tips of my fingers suddenly felt like they were being electrocuted (like touching a battery terminal), and my hands, part of my arms, and the lower portion of my face went numb and tingly. This subsided after about 20 mins, with some lingering numbness. Since then this has happened to me every single day (often multiple times, though sometimes only once or twice per day), and lasts from a few minutes to sometimes six hours. I went to an urgent care, and an after-hours clinic here in town to have this looked at, but I am working class, so too poor to be able to see a doctor regularly (or often at all) so I have no primary care physician. This still goes on in varying degrees every day. I am concerned this is permanent damage, and I cannot use my hands very well at all at my job when it is happening.
35 2021-05-30 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Was informed to sit after the vaccine. W... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Was informed to sit after the vaccine. Waited a few minutes, then sat over by the clinic. Technician informed pharmacy staff that he fainted. Staff offered him water after he regained composure. Patient stated he had a previous history of adverse events from vaccines. Will eat and drink more fluids before coming back for second vaccine.
35 2021-05-31 pain in extremity Pt was at work, laying tile, and developed sudden onset of chest, back, neck and left arm pain, with... Read more
Pt was at work, laying tile, and developed sudden onset of chest, back, neck and left arm pain, with associated dizziness around 10:15AM 5/10/21. He sat down for bit and symptoms persisted. He vomited x1 and went home, assuming he had developed the same "24 GI bug" his daughter had over the weekend. Once home he continued to feel unwell. He called his mother who proceeded to call EMS. EKG revealed anterior and inferior STE and he was taken directly to cardio lab for emergent coronary angiography, where he was found to have total thrombotic occlusion of midLAD, treated with drug-eluting stents.
35 2021-06-01 feeling hot 1st dose: within 7 minutes hot feeling throughout the body, racing hear rate up to 157 and BP 180/10... Read more
1st dose: within 7 minutes hot feeling throughout the body, racing hear rate up to 157 and BP 180/107. Monitored at the site with an oxymeter and bp monitor. Eventually it went back to normal and I was able to leave. The event of my heart BP and pulse rising happened multiple times during that day. Called my doctor after. 2nd dose: same event as first dose, but this time it came on almost immediately after the shot was completed. Elevated BP and heart rate. I was not getting better so I was wheeled in to the hospital where I had some testing done and released maybe 5 hours later. All heart tests were normal. Within about a week of the 2nd dose I was at home relaxing and my heart rate went up to 150 and then back down to 59 and then back up again. I had an oxymeter on that was monitoring it and it kept fluctuating between 59-150 and I could feel it rise and drop. I was admitted to the ER then discharged. I was told it was a possible vaccine side effect. Cardiologist appointment a few weeks later where again I was told it may have been related. Since the vaccine I have recurring episodes as detailed above. Racing heart, headaches etc.
35 2021-06-01 tingling Pt presented with rash on trunk of body that was tingly and painful, upon inquest he also revealed h... Read more
Pt presented with rash on trunk of body that was tingly and painful, upon inquest he also revealed he had been having nose bleeds and swollen gums. The pt had been out of zoloft ~5d prior to event. Recommended f/u with PCP and pt went to urgent care where he was given amoxicillin and a topical ointment for his irritation. He also refilled zoloft prescription after initial presentation. 5/24 phone f/u revealed pain was gone and rash had subsided.
35 2021-06-03 cold extremities, numbness he experienced "chest and lung pain" from the vaccine among additional side effects/severe chest pai... Read more
he experienced "chest and lung pain" from the vaccine among additional side effects/severe chest pain on the left side; more like a choking; he experienced "chest and lung pain" from the vaccine among additional side effects/moderate lung pain on both sides; throat sickness; hard to swallow; hands were really cold; face numbness; swollen inside the throat; Burning in lung on both sides; hard to breathe; itching in lung on both sides; allergic reaction; More like a pressure in the chest; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: ER8734), via an unspecified route of administration, administered in Arm Left on 26May2021 at 04:10 as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing high cholesterol from Dec2020, high low-density lipoprotein (LDL) from Dec2020 (not related to lifestyle or diet), and ongoing heartburn from Nov2020 (received omeprazole for couple of months, two weeks before vaccination for heartburn or acid reflux, for his ulcer, for GI), H-pylori (patient got two courses of antibiotics for 10 days and diagnosed with H-pylori in January), patient thought maybe the antibiotics harmed his body and allergy to grass (undiagnosed allergy to grass and it was more severe in spring in early summer). No prior vaccinations and no family history. The patient's concomitant medications were not reported. The patient previously took omeprazole on Jan2021 for heartburn (one pill one day during two-week period before vaccine administration. He took for two month and later had a break from it. He was not taking it lately). On 26May2021, the patient experienced chest and lung pain from the vaccine among additional side effects, severe chest pain on the left side, moderate lung pain on both sides, throat sickness, hard to swallow, hands were really cold, face numbness. swollen inside the throat and burning in lung on both sides, itching in lung on both sides, more like a choking, allergic reaction, more like a pressure in the chest. The patient experienced moderate lung pain on both sides. This was 40 minutes after vaccination. It was moderate. He felt a burning and itching in lungs on both sides. The patient experienced severe chest pain on the left side. Severe chest pain was 15 minutes after lung pain began. It was on the left side, mostly to the ribs, where heart is located. Pain was moderate to maybe severe. Sometimes it was a little bit hard to breathe. It was more like he was afraid to breathe because of the pain. Confirmed there was not issue with his airway. More like a pressure in the chest. As the lung pain was going away then chest pain came in. Dime size pressure. He stated he got sickness in his throat a little bit after. It was hard to swallow. He was not worried about it. He stated he was able to breath and was able to drink water. It was more like a choking. It happened after he left the vaccination site. It was maybe like 20 minutes after he had the vaccination. His hands were really cold as well after. The patient severe chest pain was improved a little bit. The chest pain on left side lasted 25-30 minutes. After that it was kind of resolved. In a couple hours it came back. The reporter stated right now it was coming back, but more lighter. It was not a severe pain (mild to moderate). It was sort of like a sore muscle in the chest. The patient had sickness in throat, when trying to swallow. The face numbness felt right after chest pain. He also felt this one hour ago, maybe on left side. He felt it for a few minutes, but not sure if it was connected. The patient also got two courses of antibiotics for 10 days. His doctor diagnosed with him with H-pylori in January. He thinks maybe the antibiotics harmed his body. He read articles about heart inflammation that lead to myocarditis or something like that. The patient thought that what he was experiencing is maybe an allergic reaction. He read articles about heart inflammation that lead to myocarditis or something like that, kids and young adults experienced chest pain after getting the Pfizer-BioNTech COVID-19 vaccine. He then explained he also read about 68 cases, among which there were 20 individuals and 2 individuals who died: a 22-year-old female and 35-year-old male. Patient thinks maybe he was experiencing an allergic reaction. No Investigation Assessment. No relevant tests. Outcome of the event Lung pain and hands were really cold was recovered on 26May2021, for chest pain, throat sickness, hard to swallow, more like a choking, hands were really cold, face numbness and more like a pressure in the chest was not recovering while unknown for rest of the events. Information on Lot/Batch number was available. Additional information has been requested.
35 2021-06-04 tingling Pins and needles feeling in left hand; This is a spontaneous report from a contactable consumer, the... Read more
Pins and needles feeling in left hand; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 08:45 hours (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 17Mar2021, the patient received Sars-cov-2 vaccine via an unknown route of administration for an unknown indication. The patient's medical history and concomitant medications were not reported. The patient had allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 09:00 hours the patient experienced pins and needles feeling in left hand. The patient did not receive any treatment for the reported event. The clinical outcome for the pins and needles was not resolved. No follow-up attempts are possible. No further information is expected.
35 2021-06-05 numbness L sided facial numbness, persisted 3-4h after dose #1, then 30 days after dose #2
35 2021-06-06 inability to speak I had symptoms consistently I had a period of aphasia.
35 2021-06-07 tingling, numbness Tingly feeling and numbness throughout my body since the vaccine shot. No other symptom but it is co... Read more
Tingly feeling and numbness throughout my body since the vaccine shot. No other symptom but it is constant. Visited the ER on Monday June 7th - testing only revealed a bulging disc in the neck. Doctors do not believe it is related to the vaccine
35 2021-06-08 weakness Three - four hours after my second dose I began to feel dizzy, fluttering in my chest, and short of ... Read more
Three - four hours after my second dose I began to feel dizzy, fluttering in my chest, and short of breath. I sat down to try to catch my breath and decided to put my heart rate monitor on (I use it when I run). My heart rate would dip into the 40s when I normally have a resting heart rate in the mid 60s. After 30 minutes of sitting and the symptoms getting progressively worse, I decided to go to the emergency room. On the way over I started feeling weak and increasingly short of breath. These symptoms lasted for approximately 8 hours. Since the episode I have noticed periodic episodes of shortness of breath and chest fluttering.
35 2021-06-09 discomfort Heart/chest pain, sharp pain, discomfort (ongoing daily-progressing) Headache, head swelling feelin... Read more
Heart/chest pain, sharp pain, discomfort (ongoing daily-progressing) Headache, head swelling feeling (ongoing daily)
35 2021-06-09 unresponsive to stimuli About one minute following vaccine administration, the patient said he was going to pass out. He los... Read more
About one minute following vaccine administration, the patient said he was going to pass out. He lost consciousness but was making snorting/snoring noises and was having muscle contractions that left him rolling around in his chair. This lasted about 2 minutes. He then turned very red and it appeared that he wasn't breathing. I removed his facemask and yelled his name/patted his chest and he began to regain consciousness. He sat for several minutes and said he felt fine.
35 2021-06-10 hot flush This is a spontaneous report from a contactable consumer (Patient). A 35-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (Patient). A 35-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 22:30 (Batch/Lot Number: EW0177) as single dose for covid-19 immunisation at the age of 35-year-old. Medical history included allergies to Penicillin, Cipro. There were no concomitant medications. On 14May2021 18:00 (as reported), the patient experienced Sleepwalking for 6 hours straight. Hallucinations. Severe sweating, heart racing, hot flash. The events were recovered without treatment. The patient was not COVID prior vaccination and hasn't been tested post vaccination.
35 2021-06-10 migraine 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrib... Read more
24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine half a day for 2nd dose; 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine half a day for 2nd dose; 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine half a day for 2nd dose; 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine half a day for 2nd dose; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number:EW0168; Expiry date: unknown),via an unspecified route of administration, in the Left Arm on 15May2021 at 13:00 as a single dose for COVID-19 immunization. The patient's medical history included disability due to back injury and nerve damage in both legs. The patient reported No allergies. The patient's concomitant medications included buprenorphine (BUPRENORPHINE); oxycodone (OXYCODONE), etodolac (ETODOLAC); baclofen (BACLOFEN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 06Jun2021 at 12:00, the patient reported for both doses, 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine that lasted 2 days for 1st dose, and so far, half a day for 2nd dose. No treatment was received for the events. The clinical outcome for the events was not recovered/not resolved. Information on Lot/Batch number was available. Additional information has been requested.
35 2021-06-10 pain in extremity, tension headache Left arm issues pinching sensation, palpatation and left side of head tension. Hard to breathe and c... Read more
Left arm issues pinching sensation, palpatation and left side of head tension. Hard to breathe and chest pain.
35 2021-06-13 bell's palsy, severe one side paralysis I was diagnosed with Bell?s palsy. Left side facial paralysis. These symptoms lasted about 3 weeks d... Read more
I was diagnosed with Bell?s palsy. Left side facial paralysis. These symptoms lasted about 3 weeks during treatment
35 2021-06-14 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient passed out about 3 minutes aft... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient passed out about 3 minutes after being given the shot. He was stiff at first but upon putting him on the floor he relaxed and opened his eyes. 911 was called, patient refused treatment.
35 2021-06-18 pain in extremity HA, dizziness, localized arm pain
35 2021-06-21 pain in extremity Arm pain resolved in 24 hrs. a few days later, I'm feeling fatigued, brain fog, and sad (the symptom... Read more
Arm pain resolved in 24 hrs. a few days later, I'm feeling fatigued, brain fog, and sad (the symptoms still persist). It's hard for me to focus on my work and enjoy what interests me. I'm not sure whether the vaccine triggered something in my body; that's why I suffer from these symptoms. My second dose is in a week; not sure what is going to happen!!!
35 2021-06-23 facial paralysis, bell's palsy Patient developed Bell's Palsy 6 months after 1st dose. Received both doses in the series. 12/18/21 ... Read more
Patient developed Bell's Palsy 6 months after 1st dose. Received both doses in the series. 12/18/21 and 1/8/21 Left sided jaw pain, then drooping mouth following by entire left sided facial droop within 3 hours involving loss of eyelid function. Started prednisone taper, valacyclovir, and lubricating eye drops within 5 hours of symptom onset. Facial droop worsened over the next 36 hours. Appears stable now.
35 2021-06-24 pain in extremity, weakness Burning feeling on skin all over body, tiredness, weakness, pain in legs.
35 2021-06-24 tingling Pfizer-BioNTech COVID-10 Vaccine EUA. Patient received his 2nd covid vaccine and felt like the midd... Read more
Pfizer-BioNTech COVID-10 Vaccine EUA. Patient received his 2nd covid vaccine and felt like the middle of his tongue was swollen. Zyrtec and pepcid administered. 10 minutes later patient reports some improvement. No difficulty swallowing or shortness of air. After 25 minutes patient reports no swelling and mild tingling, which continues to improve.
35 2021-06-24 tenderness, pain in extremity a patient who received the 2 doses of the vaccine 4 days apart; a patient who received the 2 doses o... Read more
a patient who received the 2 doses of the vaccine 4 days apart; a patient who received the 2 doses of the vaccine 4 days apart; Usual side effect of arm soreness, tenderness; Usual side effect of arm soreness, tenderness; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, NDC number, Expiry Date of Pfizer COVID-19 Vaccine: unknown), via an unspecified route of administration, administered in arm on 29Jan2021 13:30 (Batch/Lot number was not reported) as 1st dose, 30 ug, single, [30mcg injection to unknown arm] and received BNT162B2 via an unspecified route of administration on 02Feb2021 09:45 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient age at time of vaccination was 35 years. Medical history included ongoing depression and anxiety and looks like the patient has been getting treatment for depression and anxiety, further details unknown. Family history reported as none. Concomitant medications were not reported. HCP said that the patient had who received the 2 doses of the vaccine 4 days apart on 02Feb2021 and experienced usual side effect of arm soreness, tenderness on an unspecified date in 2021. The adverse events do not require a visit to emergency room and physician office and not hospitalized. No relevant tests performed. Prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. The report assessed as non-serious. Outcome of the events arm soreness, tenderness was recovered on an unspecified date in 2021. Relatedness of the events was reported as unrelated. Information about lot/batch number has been requested. The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
35 2021-06-27 bell's palsy, facial paralysis Face got dropped, was diagnosed with Bell's Palsy. The only different thing in my life was the vax... Read more
Face got dropped, was diagnosed with Bell's Palsy. The only different thing in my life was the vax. It still completely frozen up to now.
35 2021-06-28 muscle spasms, tremor, muscle twitching I started having cramps in my belly after the 1st dosage that carried over to the 2nd dosage. I star... Read more
I started having cramps in my belly after the 1st dosage that carried over to the 2nd dosage. I started having panic attacks and shakiness in my arms along with lose of weight (no appetite whatsoever). It has been like that every since and then the insomnia following the 2nd dosage and I had a feeling of bloating after I ate anything, became restless, sweating a lot, vision was blurry, and noticeable changes in my stool (became yellowish). I been gasping for air after any physical activity or eating. I also noticed that the mucus is yellowish in my throat and tongue. I also experience muscle cramps when attempting to fall asleep which causes me to wake up instantly (also happens when I eat...legs and arms start twitching). If I try to swallow, the yellowish mucus wakes me up while I am trying to sleep. The symptoms started gradually and I didn't have anything of them prior to taking either dosage of the vaccine. The emergency medical team did some tests upon arriving at my home to see if I needed to be transported to the hospital (was not necessary since my heart was working fine).
35 2021-06-28 muscle spasms The first reaction I had on 05/19/2021 was body pain from my back to all over my front side which fe... Read more
The first reaction I had on 05/19/2021 was body pain from my back to all over my front side which feels like I'm having a heart attack without the shortness of breathe. Whenever I moved my head forward, I experienced a cramping pain and it was the first time for me. I alerted my wife that my back was really hurting and the next day when I woke up, I felt sick with eye pain even though I wear glasses (have never happened to me before). The pain became worst as the day progressed (a pulsating pain at the back of my eyes and whenever I moved, I felt like I was going to faint. I stayed in bed because I could not move (includes light sensitivity...room has to be dim all the time and on May 27, I lost partial hearing in the left ear along with ringing in my ear). I was not sick and wanted to know what was going on (went to the ENT). The lost happened for 4 days and then it moved to the right ear on May 29 and I lost my hearing and it made me afraid that I would lose my hearing (went on and off for several weeks with both ears). I'm a Nurse and I told my wife that it may be an autoimmune reaction but I have never had any illness; therefore, I took Loratadine. My PCP prescribed me Advil and Tylenol but the pain did not go away in my ears and it didn't work. I also still have eye pain and can drive because now (having been taking Vitamins B-12 and B-6 to help me recover). I also have a change in my taste buds. The ringing in my ears and the hearing lost scared me the most. The headaches will probably be with me a while since the progress is so slow. I also still have pain at the back of my eyes. I also had one episode of vertigo and also a time when I felt that my legs had weakness in them.
35 2021-06-28 pain in extremity 24 hours after vaccine I started feeling icky and bad. I was working and thought I was going to pass... Read more
24 hours after vaccine I started feeling icky and bad. I was working and thought I was going to pass out so I went home, and I tried calling the hospital, but they said they couldn't recommend if I should go in or not. A week after that every joint in my body was killing me. I had a little bit of breathing issues probably about a week after. Chest tightness, not being able to get a full breath. 48-72 hours after that my knuckles and joints were hurting. 48 hours after that the tightness in chest started and the trouble breathing. I did not go to an urgent care. My brain just feels like it shut off a little bit and I don't know if that's just something in my head or not.
35 2021-07-06 feeling cold, weakness Woke up at 5 am sweating, but freezing when not under the blanket. Temperature 99.1 F. Headache. No ... Read more
Woke up at 5 am sweating, but freezing when not under the blanket. Temperature 99.1 F. Headache. No pain, except for the headache, and the bruise feeling of where the vaccine got injected (which is normal for me each vaccination I had in my life had that feeling the next day). No appetite and weak feeling. Those flu like symptoms lasted the entire day and all I could eat was a soup and drank tee.
35 2021-07-06 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: After vaccination patient was instruct... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: After vaccination patient was instructed to wait 15 minutes in the store, within a few minutes pharmacist was alerted patient had fainted. 911 was contacted immediately, patients vitals were checked, patient was breathing/normal pulse. Patient became responsive and allerted severe anxiety to needles and noted fainting had occured in the past.
35 2021-07-08 unresponsive to stimuli, flushing Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Conf... Read more
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Additional Details: called 911, taken to hospital,
35 2021-07-12 pain in extremity, cold sweat ARM PAIN, COUGHING, LETHARGIC, CHEST PAIN, CLAMMY,
35 2021-07-13 pain in extremity Persistent arm pain, weakness, feels like an injury. Left shoulder and wrist. Rested for 2.5 weeks... Read more
Persistent arm pain, weakness, feels like an injury. Left shoulder and wrist. Rested for 2.5 weeks and the pain subsided some but still remains (1 month so far). Difficulty sleeping on left side.
35 2021-07-17 pain in extremity Fatigue; Slight sore arm; This is a spontaneous report from a contactable consumer, the patient. A 3... Read more
Fatigue; Slight sore arm; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male 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 27Mar2021 at 09:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were 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 not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 28Mar2021 at 07:00, the patient experienced fatigue and slight sore arm. 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 treatment for the adverse events. The clinical outcome of the events fatigue and slight sore arm were resolving at the time of this report. No follow-up attempts are needed; information about lot number cannot be obtained.
35 2021-07-19 weakness Severe weakness; Chills; Fever (~100f); Joint pain; Headache; This is a spontaneous report from a co... Read more
Severe weakness; Chills; Fever (~100f); Joint pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 28Mar2021 at 18:00(at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included amblyopia, blood pressure high and strabismus. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. The patient had no known allergies to medications, food, or other products. 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 COVID vaccine. On 30Mar2021 at 03:30, the patient experienced chills, fever (~100f), joint pain, headache, severe weakness. 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. Therapeutic measures were taken as a result of reported events and included treatment with over-the-counter ibuprofen. The clinical outcomes of the event chills, fever (~100f), joint pain, headache, sever weakness were recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
35 2021-07-22 seizure Pt had vaccine on 7/8 and had a seizure on 7/13. He was at work and was found with blood on his ear ... Read more
Pt had vaccine on 7/8 and had a seizure on 7/13. He was at work and was found with blood on his ear and a mark on his face. He had no memory of the incident. Last seizure was at least 7 months prior.
35 2021-07-24 burning sensation On July 2nd I started feeling very nauseated and had a little bit of back pain, the next day I start... Read more
On July 2nd I started feeling very nauseated and had a little bit of back pain, the next day I started to experience a high fever and was feeling very exhausted. Two days later, on the 5th I started to come down with fatigue to the point I was very tired and only could sleep for 5 minutes. I then started to realize I had an itching and burning sensation on my shin due to having a rash. I did a virtual doctor's appointment and they thought it could have been cellulitis forming on my shin, I still have to go in to receive the test before ruling that out. I also experienced teeth pain throughout the day which made it uncomfortable to chew.
35 2021-07-25 trigeminal neuralgia, tenderness Morning after receiving the second Covid shot started experiencing debilitating head and face pain o... Read more
Morning after receiving the second Covid shot started experiencing debilitating head and face pain on the left side, it was tender to touch. After several weeks of the constant pain, I went to see my a doctor. My doctor ordered an MRI and referred me to a neurologist. My neurologist reviewed the MRI and said it was normal. She suggested it may be trigeminal neuralgia and prescribed Carbamazepine 100 Mg Chewable Tablet. I then missed a week of work.
35 2021-07-27 pain in extremity, discomfort Headache; low fever; nausea; fatigue; loss of appetite; general discomfort; sore arm; This is a spon... Read more
Headache; low fever; nausea; fatigue; loss of appetite; general discomfort; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm right on 27Apr2021 at 10:30(at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included food allergy like allergy to walnuts, apples and many stone fruits. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and naproxen sodium (ALEVE) since an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm right on 06Apr2021 at 14:00 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 had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Apr2021 at 02:00, the patient experienced headache, low fever, nausea, fatigue, loss of appetite, general discomfort and sore arm. It began approximately 14 hours after injection and easing 28 hours after injection and completely gone within 40 hours but still had sore arm. 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 clinical outcome of the event headache, low fever, nausea, fatigue, loss of appetite and general discomfort were recovered on an unknown date in Apr2021. The clinical outcome of the event sore arm was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
35 2021-07-27 seizure About 3 minutes after the vaccination was administered patient fell off their chair and began seizin... Read more
About 3 minutes after the vaccination was administered patient fell off their chair and began seizing. The seizure lasted about 20 seconds. Patient was on the floor in the fetal position, eyes rolled back and seizing. After the patient was alert and oriented. No history of seizures or diabetes. Paramedics arrived and took patient from there.
36 2020-12-31 cold sweat, tingling Few minutes after receiving injection developed lightheadedness/dizziness, nausea, palpitations, gen... Read more
Few minutes after receiving injection developed lightheadedness/dizziness, nausea, palpitations, generalized tingling sensation, clamminess. Upon checking vitals was tachycardic with heart rate in 120s; drop in blood pressure to 100/50 (my baseline is 120/75). No wheezing. No stridor. Oxygen saturations 99%. No hives or rash. No facial or peripheral swelling. Provided fluids (by mouth), cold compresses, and benadryl. Gradual improvement after this. Majority of symptoms lasted for approx 1 to 1.5 hours; with some waxing/waning palpitations for another~1 hour. I have no prior history of similar symptoms after receiving vaccines or medications in the past.
36 2021-01-04 throat numbness, migraine Patient reported a "migraine headache at the back of the head within 5 minutes of receiving the Pfiz... Read more
Patient reported a "migraine headache at the back of the head within 5 minutes of receiving the Pfizer COVID 19 vaccine at 9:45am on 01/04/2021. Symptoms were quickly followed by itching of the head and ears. Within twenty minutes his tongue, lips, and throat felt tingly and numb. He stated he was taken by EMS to hospital where he was given Benadryl and monitored for 2 hours. Today he reports a mild headache, chills, soreness at the site of the injection with slight burning, and fatigue. He stated, "I'm fine." Infection Prevention specialist for hospital reports that patient chart indicated he had no evidence of tongue or lip swelling. His vitals at the ER were stable and he was observed for over an hour. He was given oral zofran, acetaminophen, and benadryl.
36 2021-01-06 feeling of body temperature change On/Off Head Cold On/Off Hot/Cold Chills One Hour of the Runny Defecation. Loss of Apatite General F... Read more
On/Off Head Cold On/Off Hot/Cold Chills One Hour of the Runny Defecation. Loss of Apatite General Feeling of being Unwell
36 2021-01-07 burning sensation Shingles left flank, mild case so far
36 2021-01-07 slurring, tingling Pt was vaccinated at 1125 At 1157 pt was observed - with rash around neck, chest and back, dry mouth... Read more
Pt was vaccinated at 1125 At 1157 pt was observed - with rash around neck, chest and back, dry mouth and slurred speech, heavy arms, tingling in arms. Pt was very hard to communicate with - could not articulate - pt was taken to the ER via wheelchair and examined.
36 2021-01-07 pain in extremity Arm sore within 5 hours, Headache within 10 hours that lasted for about 14 hours
36 2021-01-08 cold sweat c/o feeling dizzy and diaphoretic a few minutes after receiving vaccine. Was pale and clammy to touc... Read more
c/o feeling dizzy and diaphoretic a few minutes after receiving vaccine. Was pale and clammy to touch. Laid down and given water and candy. Felt better after 15 minutes and discharged back to work.
36 2021-01-09 weakness Severe debilitating chills. Worse than any previous infection experienced. Unable to move. Mildly im... Read more
Severe debilitating chills. Worse than any previous infection experienced. Unable to move. Mildly improved with Motrin. Had low grade 100.3 F fever. Weakness aches lymphadenopathy. Severity of symptoms of reduced from severe to mild in just over 48 hours.
36 2021-01-09 numbness, pain in extremity numb hand 24 hours after injection; arm pain; shoulder and neck pain; fever 101degrees
36 2021-01-11 migraine It started with a headache felt like migraine. On 12/26 exp difficult breathing, felling fatigue wit... Read more
It started with a headache felt like migraine. On 12/26 exp difficult breathing, felling fatigue with fever of 102, joint pain in fingers/toes moving to wrist and ankles. Then on 12/27 the joint pain was traveling to knees and 12/28. The symptoms got severe on12/29 followed with a cough. By the 12/30 cough was still there and joint pain. On 12/31 still exp cough until 1/4 and less joint pain. I missed 2 1/2 days of work.
36 2021-01-11 pain in extremity Erythematous raised rash started on the left arm 01/10/21, the following day blisters appeared and t... Read more
Erythematous raised rash started on the left arm 01/10/21, the following day blisters appeared and the rash became painful. Prior to that there was shock-like pain through the left arm starting on the day after the vaccination. Suspect likely shingles
36 2021-01-11 pain in extremity Symptoms began on 01/10/2021 around 3:30-4:00 AM PST. I had body aches for 2 days. I woke up on 01/1... Read more
Symptoms began on 01/10/2021 around 3:30-4:00 AM PST. I had body aches for 2 days. I woke up on 01/11/2021 with soreness in my right arm pit. I woke up today, 01/12/2021 and had pain and swelling in my right arm pit. I went to my employer's employee health services and was checked out by a provider. I was told that he didn't see anything, and he minimized my symptoms. He didn't seem like he wanted to evaluate me from the time he walked in the exam room. He told me "what do you want us to do? It looks normal." He then went on to tell them he's not going to give me time off for work aside from today. I did not ask for any time off once during the evaluation. I recheck my arm pit when I got home, and noticed the swelling is approx. 3"x 3"s. It was not hard to see when I rechecked. I have noticeable pain the swollen area as well. The swelling is visible when I extend my right arm all the way up above my head. I attempted to tell the employee health provider this, but he preferred to check in a manner that does not show the swelling. I am slightly muscular and when my arm is down, you can only feel soft tissue. Employee health gave me Ibuprofen to treat my Sx's. I called my primary physician's office and am waiting for a call back to be either scheduled for an evaluation or receive medical advice.
36 2021-01-11 tingling, cold sweat Disorientation, tunnel vision, blurred vision, difficulty breathing, chest tightness, severe palpita... Read more
Disorientation, tunnel vision, blurred vision, difficulty breathing, chest tightness, severe palpitations, tachycardia, cold and clammy, tingling to extremeties, unable to verbalize thoughts and organize words. And feeling that I was going to lose consciousness.
36 2021-01-11 tingling Heart rate increased; Feeling a little lightheaded; Tingling in nostrils and lips; Tingling in nostr... Read more
Heart rate increased; Feeling a little lightheaded; Tingling in nostrils and lips; Tingling in nostrils and lips; This is a spontaneous report from a contactable other-HCP. A 36-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 19Dec2020 (Saturday) at single dose for covid-19 immunization. The facility type vaccine was hospital. Medical history included obesity, Sleep apnea, seasonal allergy. The patient's concomitant medications were not reported. After receiving the vaccine, 15-20 minutes afterwards patient began having an increased heart rate, feeling a little lightheaded and they brought patient back into the room. They monitored his vitals and then he started having tingling in his nostrils and lips but his blood pressure was fine. He didn't have any throat closure or anything like that but they monitored him in the emergency department for approximately an hour or so and they let him go and gave him the medications. Patient didn't received any treatment. The outcome of the events was recovering. Patient took CMB and EMP test. Patient further stated he was just trying to figure out should he get the second dose or not of the vaccine. Information about lot/batch number has been requested.
36 2021-01-12 numbness Left side face numbness; hypertension; tachycardia; lightheadedness; This is a spontaneous report fr... Read more
Left side face numbness; hypertension; tachycardia; lightheadedness; This is a spontaneous report from a contactable other healthcare professional (patient himself). A 36-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Elo140), intramuscularly at site of left arm at 11:15 on 19Dec2020 at single dose for COVID-19 immunization. Medical history included known allergies: environmental, sulfa. Concomitant medication included ibuprofen within 2 weeks of vaccination. The patient experienced left side face numbness, hypertension, tachycardia and lightheadedness, all at 10:00 on 05Jan2021. All events were identified as non-serious by reporter. The patient received lisinopril 10mg, electrocardiogram (EKG) and blood work for treatment. Facility where the most recent COVID-19 vaccine was administered was in hospital. The patient did 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. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was unknown.
36 2021-01-13 feeling cold pain on eye movement; high fever; joint/muscle ache; joint/muscle ache; headache; nausea; unable to ... Read more
pain on eye movement; high fever; joint/muscle ache; joint/muscle ache; headache; nausea; unable to sleep; shivered most of the night unable to feel warm; shivered most of the night unable to feel warm; First dose: 18Dec2020 10:00 AM; second dose: 04Jan2021 11:45 AM; First dose: 18Dec2020 10:00 AM; second dose: 04Jan2021 11:45 AM; This is a spontaneous report from a contactable physician (patient himself). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899), via intramuscular on 04Jan2021 11:45 at single dose in left arm for covid-19 immunization. Medical history included allergies: allergy to certain sunblock. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (lot number EH9899) for covid-19 immunization on 18Dec2020 10:00 AM in left arm via intramuscular. The most recent COVID-19 vaccine was administered was in hospital. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Roughly 12hrs after second vaccine (05Jan2021), patient had high fever, and accompanying symptoms such as joint/muscle ache, headache, nausea. Fever was severe enough, patient was unable to sleep and shivered most of the night unable to feel warm, patient was also unable to check temperature due to status of severe symptoms. Upon waking in the early morning, fever was better, symptoms of headache/nausea/joint/muscle ache persisted rest of day. Fever was around 101 rest of day time. By second day (05Jan2021 12:00 am), fever subsided, residual mild headache and pain on eye movement remained for another day. Eye pain on movement persisted for 4 days after fever. The patient took ibuprofen 200mg for high fever, joint/muscle ache, headache. Events were assessed as non-serious. Outcome of these events were recovering.
36 2021-01-13 feeling cold Severe chills; aches; general malaise, low grade fever lasting 2-3 hours. Acetaminophen and ibuprof... Read more
Severe chills; aches; general malaise, low grade fever lasting 2-3 hours. Acetaminophen and ibuprofen
36 2021-01-13 nerve pain Muscle pain; Dizzy; face swelling; Dry heaving; Neck swelling; hip pain, soreness, and his back and ... Read more
Muscle pain; Dizzy; face swelling; Dry heaving; Neck swelling; hip pain, soreness, and his back and shoulders are sore as well, joint achiness; hip pain, soreness, and his back and shoulders are sore as well; hip pain, soreness, and his back and shoulders are sore as well.; brachial plexus origin there was a sharp stabbing pain shooting down; rash was all over his body, but mostly on his back; drowsy; injection sight swelling in his arm; he did kind of feel like something was sitting on his chest; This is a spontaneous report from a contactable consumer. This 36-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Medical history included pre-existing back injury that caused neuropathy, damaged nerves, and chronic sciatica, all in 2009. There were no concomitant medications. On 05Jan2021, the consumer experienced muscle pain, joint achiness which got painful. He was dizzy. His girlfriend noticed a rash on his body. It was welted, but not itchy. His face and neck swelled up. He was dry heaving and couldn't throw up. He was given diphenhydramine hydrochloride (BENADRYL) and steroid shots in the ER. About 4.5 hours after the vaccine, the same day was when it all came on. At 8 o'clock, it got worse. The consumer had hip pain, soreness, and his back and shoulders are sore as well. He was dizzy and drowsy. At 11pm that night, his face was swollen and his neck was swollen. The rash was all over his body, but mostly on his back. He had injection sight swelling in his arm. At his brachial plexus origin there was a sharp stabbing pain shooting down his arm. It did go away. He recovered completely. That stabbing pain lasted from the 5th-6th. He has hip pain, soreness, and his back and shoulders were sore as well. They are ongoing, but improving. He has taken diphenhydramine hydrochloride (BENADRYL) and ibuprofen (MOTRIN). He has not had a fever. His neck still has a little swelling. He didn't have difficulty breathing. But he did kind of feel like something was sitting on his chest. He received a steroid. The consumer had to go to the ER visit. He was there over night from 05Jan2021 to 06Jan2021. The consumer went to get a free COVID test, and they had the vaccine available. The outcome of the event dizzy, face swelling, dry heaving, brachial plexus origin there was a sharp stabbing pain shooting down his arm was recovered on 06Jan2021. The outcome of muscle pain, neck swelling, hip pain, soreness, and his back and shoulders are sore as well, joint achiness was recovering. The outcome of other events was unknown.
36 2021-01-13 pain in extremity Had severe reaction to the vaccine not necessarily adverse events but still wanted to report it. I a... Read more
Had severe reaction to the vaccine not necessarily adverse events but still wanted to report it. I am a physician who likely had contracted COVID in 04/2020 and has been suffering long COVID sx since. No significant reaction to dose 1 of the Pfizer vaccine other than sore arm. 2nd dose within 12 hours had severe rigors, severe chills, then fever to 39.6 the first night (took 1 dose of tylenol and 1 of advil after), temp of 38-39 the next 12 hours, and then the 2nd night had a fever high of 41.4 degrees (took another tylenol). Had sweats the entire night after and defervesced after. Day 3-5 mostly involve myalgia, nausea, anorexia, malaise, chills, HA, and mild SOB. Took about 1 week to "recover" to my long COVID baseline after the 2nd dose of vaccine. Still having a bit worse SOB now compared to prior to 2nd dose but unsure if it has to do with the vaccine at this point. Had tested for positive anti-spike protein ab (likely from the 1st dose) the morning of my 2nd dose of vaccine.
36 2021-01-13 pain in extremity Fever, Malaise, Chills, aching limbs
36 2021-01-17 weakness, pain in extremity, flushing Woke up around 3pm flushed with temperature in the low to mid 99 degrees with a sore left arm (3 day... Read more
Woke up around 3pm flushed with temperature in the low to mid 99 degrees with a sore left arm (3 days) and some weakness (2 days). Accompanied by a painful headache as well as nausea. Headache for most of the day with varying pain severity. Nausea for about two and a half days on and off which is unusual for me to be nauseated.
36 2021-01-17 slurring slurring speech; rash around his neck and upper chest; his earlobes were bright red, as was his nose... Read more
slurring speech; rash around his neck and upper chest; his earlobes were bright red, as was his nose; mouth was dry; nose was dry; dry throat; almost "drunk"; Only abnormal finding was BP 159/94; This is a spontaneous report from contactable pharmacist. A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1283 and Expiration Date unknown) via Intramuscular on 08Jan2021 11:25 at single dose for COVID-19 immunisation. The patient's medical history was reported toradol made him feel lightheaded and foggy (similar to his first Pfizer BioNTech covid vaccine), Attention deficit hyperactivity disorder (ADHD). History vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number =EK5730 and Expiration Date unknown) via Intramuscular on 18Dec2020 at single dose for COVID-19 immunisation. Patient did report that on first vaccine it made him feel a little sluggish, tired and foggy minded. The concomitant medications were reported as amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall XR) at 25mg twice a day (BID) and escitalopram oxalate (LEXAPRO) oral (PO) at 10mg every day. No other vaccine in four weeks. Patient was vaccinated at 11:25. Patient was observed for 30 minutes. Pharmacist checked on patient at 17 minutes after vaccination - he was fine able to communicate and showed no signs of distress. Pharmacist came back and checked on patient at 25 minutes after vaccination (11:50) and patient was slurring speech, had developed rash around his neck and upper chest, his earlobes were bright red, as was his nose - mouth was dry, reported dry throat - no visible swelling of the lips or tongue. Patient was transported to ED (2 min) Home meds: Adderall XR 25mg BID [Twice a day], Lexapro 10mg Q [every]PM. Only abnormal finding was BP 159/94 - after initial workup patient was noted to be almost "drunk" as reported by Emergency Room (ER Doc). Patient was offered diphenhydramine declined several times but eventually agreed. Approx 30 min after diphenhydramine patient fully recovered and stated "I'm back". The second dose reaction was much more exaggerated and lasted much longer. No COVID prior vaccination and no COVID tested post vaccination. The adverse event result in Emergency room/department or urgent care. The outcome of events was recovered in Jan2021 after treatment was given.; Sender's Comments: Based on the time association, all 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.
36 2021-01-18 weakness, face paralysis 5 days after vaccination developed bilateral hand weakness. Next day bilateral facial weakness. Sub... Read more
5 days after vaccination developed bilateral hand weakness. Next day bilateral facial weakness. Subsequent days weakness worsened and spread to shoulders, arms, upper legs. Plateaued after about 7 days then began to improve around day 10, symptoms continue to resolve.
36 2021-01-18 pain in extremity, weakness, flushing Woke up around 3pm flushed with temperature in the low to mid 99 degrees with a sore left arm (3 day... Read more
Woke up around 3pm flushed with temperature in the low to mid 99 degrees with a sore left arm (3 days) and some weakness (2 days). Accompanied by a painful headache as well as nausea. Headache for most of the day with varying pain severity. Nausea for about two and a half days on and off which is unusual for me to be nauseated.
36 2021-01-19 weakness 2nd dose of COVID vaccine received approx 0800 on 1/19/21, felt healthy throughout the day. Began to... Read more
2nd dose of COVID vaccine received approx 0800 on 1/19/21, felt healthy throughout the day. Began to feel flu like symptoms approx 1800 on the evening of 1/19/21. Symptoms worsened through the night rapidly, beginning with uncontrollable chills/shivering, body aches, restless, slight vertigo, weakness/fatigue. At approx 0100 the morning of 1/20/21, blacked out while in the bathroom of which awoken and found myself disoriented, weak, and on the ground (no injuries noted as i must have eased myself down). I was able to hydrate afterwards and tolerate eating some dry cereal to help with the weakness. Symptoms began to dissipate while an intense headache continued throughout the night and even through the daytime. The time is now 1020 on the day of 1/20/21 and i still have quite the headache but all other symptoms seem to be relieved at this time.
36 2021-01-20 burning sensation, numbness STARTED HAVING BILATERAL UPPER EXTREMITY PARESTHESIA/BURNING SENSATION AND LEFT LOWER EXTREMITY PAR... Read more
STARTED HAVING BILATERAL UPPER EXTREMITY PARESTHESIA/BURNING SENSATION AND LEFT LOWER EXTREMITY PARESTHESIA/BURNING THE EVENING AFTER RECEIVING THE VACCINE.
36 2021-01-20 tenderness Swelling of underarm lymph nodes of left arm. First noticed tenderness under arm on post vaccination... Read more
Swelling of underarm lymph nodes of left arm. First noticed tenderness under arm on post vaccination day 1. Swelling noticeable on day 2 (Friday 1/15/21). Swelling still present as of 1/21/21, though reduced and no longer tender.
36 2021-01-21 weakness Felt mild chills and somewhat low energy that night and following morning. Nothing more than that an... Read more
Felt mild chills and somewhat low energy that night and following morning. Nothing more than that and the muscle soreness.
36 2021-01-21 sciatica, muscle spasms Lower back spasms and sciatic pain radiating down left leg with leg giving out.
36 2021-01-24 depressed level of consciousness Patient received vaccine without incident. As patient was walking to the observation area, he felt a... Read more
Patient received vaccine without incident. As patient was walking to the observation area, he felt a little dizzy. He ambulated to the observation room without difficulty. As he was sitting in the chair in observation he passed out in the chair with observer present who caught him and then the patient was placed in a wheelchair to take him to private observation area. By the time he was wheeled to the private area he was semi-alert. Vital signs were taken, EMS was called. Patient became fully alert within 5 minutes. He was diaphretic. VS were within normal limits. Patient did state he had a very light lunch. He had something to eat in the ambulance and felt better. EMS returned him to the clinic after about 30 minutes and patient stated he felt fine.
36 2021-01-24 flushing, pain in extremity 12h post vaccination: headache, chills, flush/pruritus, malaise, fatigue, arm soreness (acetaminophe... Read more
12h post vaccination: headache, chills, flush/pruritus, malaise, fatigue, arm soreness (acetaminophen, antihistamine, hot shower, sleep) 24h post vaccination: symptoms resolved except malaise and headache (acetaminophen) 48h post vaccination: symptoms resolved ~10 days post vaccination: maculopapular rash on R flank ~14 days post vaccination: maculopapular rash spread to entire torso and bilateral upper extremities
36 2021-01-25 numbness facial numbing; This is a spontaneous report from a contactable healthcare professional (patient). A... Read more
facial numbing; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old male patient received his first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EJ1685) intramuscularly at 10:45 13Jan2021 at left arm for Covid-19 immunization. The patient had no known allergies and had no medical history or concomitant medications. Approximately 20 minutes after administration of the vaccine (13:15PM), the patient began to experience facial numbing, the feeling as similar to the return of sensation after having a numbing agent (at the dentist, for instance). He was more aware than usual of an effort required to move his face. It was not unpleasant, apart from being concerning- He did not know when or if this symptom might pass. Within 90 minutes of onset the sensation was 90% resolved. There was minor sensation with smiling until awakening the next day (approximately 19 hours after administration). No treatment was received for the event. The patient had no Covid-19 before vaccination and had not tested for it. The event resolved at the time of reporting (unspecified date in Jan2021).
36 2021-01-27 feeling hot Developed rash on back approximately four hours after vaccination. Hives/rash located in four clust... Read more
Developed rash on back approximately four hours after vaccination. Hives/rash located in four clusters across upper back - 2 clusters near shoulder blades and 2 clusters below those. The hives are bright red and hot with the two clusters on the left side having a blister like center seemingly filled with yellow liquid. The hives/rash are extremely itchy and warm to touch. The vaccination site has a knot underneath the skin and is warm and sore.
36 2021-01-28 tingling Approximately 30 minutes after receiving his injection he returned to the site complaining that he... Read more
Approximately 30 minutes after receiving his injection he returned to the site complaining that he experienced a " split second second of dizziness and became light headed and had a tingling sensation to his left arm (the arm that he received the vaccine in.)" right after he left. He said it came and left quickly. He said the symptoms were gone and he felt fine and then he felt the symptoms again while nurse was checking his b/p. Those symptoms left quickly as well. EMS came to evaluate the patient.
36 2021-02-01 weakness Chills, fever, body aches, head ache, and weakness.
36 2021-02-01 cold sweat, slurring Checking on patient after vaccine administered. Patient was lethargic & described head hurting. Pa... Read more
Checking on patient after vaccine administered. Patient was lethargic & described head hurting. Patient has diabetes. Became diaphoretic shortly thereafter with a BP of 180/110, HR 115 and RR 26. LOC's decreased. Chest rubs began. Patient given Coke, but unable to drink effectively. 2 packs of granular sugar put under tongue. Patient began to slur words, skin clammy. Epi-pen administered in right arm and patient was moved out of car to the ground. Patient began to shiver and slurring words. We began to warm patient. EMS arrived and took over. Patient transported to Hospital.
36 2021-02-01 tremor At around 11pm I had the chills, I was shaking pretty bad, no fever and I had a major headache. I do... Read more
At around 11pm I had the chills, I was shaking pretty bad, no fever and I had a major headache. I do not have any access to tylenol and I will wait to take some when I arrive home at 7am. Its about 530am and I still have a headache. I've been drinking lots of water and I feel nauseous now.
36 2021-02-02 pain in extremity Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was d... Read more
Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was diluted incorrectly with less Normal Saline than require. This error was not noticed until person mixing vaccine said they were out of vaccine and did not have enough to get 5 dosages of 0.3ml. Two people mixed one vial of vaccine together demonstrating to the other. It appears the person making the error did not notice they did not have 1.8ml of NS but must have had some air and did not realize it. The error was noticed when all the vaccines were given and one person had not completed pulling up the vaccine. So, 2 of 7 patients received the incorrect dose of vaccine and it could not be determined which two received the incorrect dose. Patient Reports: Sore arm for several days
36 2021-02-04 migraine Whole body moderate muscular weakness and fatigue beginning 18 hours after injection, increasing in ... Read more
Whole body moderate muscular weakness and fatigue beginning 18 hours after injection, increasing in severity to 36 hours after injection. Moderate to severe migraine beginning 24 hours increasing to 36 hours after injection. Full recovery 42 hours after administration.
36 2021-02-07 sciatica sciatica with pain radiating from lower back to glute and then down to the left foot; This is a spon... Read more
sciatica with pain radiating from lower back to glute and then down to the left foot; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247), intramuscular in the left arm on 19Jan2021 at 13:15 at a single dose in the Nursing Home/Senior Living Facility for COVID-19 immunization. Medical history included stroke, hodgkin's lymphoma, cerebral vasculitis, seizures, chronic venous insufficiency, and had COVID prior to vaccination. Concomitant medication included levetiracetam (KEPPRA), apixaban (ELIQUIS), and levothyroxine sodium (SYNTHROID). The patient experienced sciatica with pain radiating from lower back to glute and then down to the left foot on 19Jan2021. Leg feels like it is going to give out. The patient did not receive treatment for the event. The patient was not tested for COVID post vaccination. The patient was recovering from the event.
36 2021-02-09 weakness fever of 100.6-102.5 for 2 days, chills/shivering, weak, body aches, headache. Tylenol and stayed h... Read more
fever of 100.6-102.5 for 2 days, chills/shivering, weak, body aches, headache. Tylenol and stayed hydrated
36 2021-02-09 burning sensation, pain in extremity, feeling hot, discomfort THE FOLLOWING DAY AFTER ADMINISTERING THE VACCINE STARTED APPEAR "RASH" ALL OVER THE BODY, ITCHING, ... Read more
THE FOLLOWING DAY AFTER ADMINISTERING THE VACCINE STARTED APPEAR "RASH" ALL OVER THE BODY, ITCHING, FELT WARM (TEMPERATURE WAS NOT TAKEN) AND PAIN IN BOTH LEGS FROM THE KNEE TO THE ANKLE. FEELS BURNED SENSATION IN BOTH HEELS AND CAN'T WALK WELL. IN ADDITION TO GENERAL DISCOMFORT. A TABLET OF ATARAX WAS TAKEN AND BENADRYL OINTMENT WAS APPLIED, COLD WATER COMPRESSES WERE APPLIED BUT IT DOES NOT IMPROVE. STILL HAVE THE "RASH"
36 2021-02-10 burning sensation, tingling - Tender, mobile and swollen axillary lymph node (ongoing) - ice and advil seem to help a little - B... Read more
- Tender, mobile and swollen axillary lymph node (ongoing) - ice and advil seem to help a little - Burning and stinging sensations in the right axilla (ongoing) - ice and avoiding contact between lateral chest and right upper arm seems to help a little - Intermittent paresthesias in the right axilla and chest wall (ongoing)
36 2021-02-14 weakness She said she was weak after the vaccine. Onsite EMS was requested.bp 127/87 hr 88 99% O2 on room air... Read more
She said she was weak after the vaccine. Onsite EMS was requested.bp 127/87 hr 88 99% O2 on room air. They were able to find a specific cause and she refused additional workup
36 2021-02-16 weakness, pain in extremity, speech disorder S&S: "not 100%", leg pains, lumbar pain, stiff neck, short-term memory loss; Vital signs were stable... Read more
S&S: "not 100%", leg pains, lumbar pain, stiff neck, short-term memory loss; Vital signs were stable; denies vision changes, H/A (nonretractable to meds), balance changes, weakness, speech abnormalities. Tx: Patient educated on post COVID-19 syndrome, Tylenol for pain, pseudoephedrine for congestion, labs for Liver enzymes, discussed possible neurology referral, follow-up w/ PCM on 2/4/2021 (14 days after initial visit).
36 2021-02-17 feeling cold 36 yo man with hx developmental disabilities here with caregiver and mother for second Covid vaccin... Read more
36 yo man with hx developmental disabilities here with caregiver and mother for second Covid vaccine. In observation area he was noted to become poorly responsive, pale at 12:55 pm. Initial VS P 127, thready but regular, pulse ox 98%,, B/P 90/50 and difficult to hear. Oxygen started at 3 L NC. Patient placed supine on mat. He remained pale, arms cool and diaphoretic, tachycardic. He was able to answer questions. Denied c/o chest pain or SOB. Denied headache. No rash noted, no stridor. 1:11 pm 99% sat, P 127. 1:15 pm given three small pieces of fruit snack. No change noted . 1:22 pm VS: 120/80, P 123, Sat 99%. Pulse remained thready but stable and B/P remained difficult to auscultate. 1:27 pm VS 95/78, P 120 sat. 99%. 1:41 pm B/P 110/85, P 124 99% sat. Paramedics called at 1:43 pm. Paramedics arrived 1:51 pm and report given. Patient transported to ER for further eval. Mother and caregiver present throughout observation period.
36 2021-02-17 muscle spasms Swelling of forearm by 60%; muscle spasms in pectorial muscle; This is a spontaneous report from a c... Read more
Swelling of forearm by 60%; muscle spasms in pectorial muscle; This is a spontaneous report from a contactable consumer. A 36-years-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), lot number=EL3247, via an unspecified route of administration in the left arm, on 22Jan2021 at 08:45 (at the age of 36 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a doctors office/urgent care. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) received within 2 weeks of vaccination. On 23Jan2021 at 0800, the patient experienced swelling of forearm by 60%, and muscle spasms in pectoral muscle. The patient was not hospitalized for the event nor received treatment. The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
36 2021-02-17 tension headache 48 hrs after receiving first dose of Pfizer Covid 19 vaccine I started to feel tension type headache... Read more
48 hrs after receiving first dose of Pfizer Covid 19 vaccine I started to feel tension type headaches that were moderate but sometimes can be severe and disabling. These headaches persist daily since the first dose of the vaccine. I still have them today. Duration has been almost two months. No other associated neurologic symptoms at this moment. I dont have any past medical history and never had issues with headaches before. Contacted neurologyst with specialty in headaches for treatment. Labs and MRI without contrast are within normal limits. I used a series of NSAIDS to see if it helped the pain without success. Also did the Botox treatment, which improved headaches but didnt resolve symptoms.
36 2021-02-20 inability to speak Please reference separately submitted MIS-A form. He had sore throat, high fever, diarrhea, deteri... Read more
Please reference separately submitted MIS-A form. He had sore throat, high fever, diarrhea, deteriorating in to multisystem failure and apparent acute myocarditis, notably with relative initial sparing of the lungs. He suffered cardiac arrest in radiology after developing aphasia and was transferred to Hospital after cannulation for VA ECMO; he died there 2/8/21.
36 2021-02-21 tingling EXPERIENCED NUMBING AT THE BASE OF THE TONGUE THE EVENING OF 2/13/21. EXPERIENCED TINGLING AT THE N... Read more
EXPERIENCED NUMBING AT THE BASE OF THE TONGUE THE EVENING OF 2/13/21. EXPERIENCED TINGLING AT THE NAPE OF THE HEAD 2/14/21. PT WAS NOT ABLE TO CLOSE LEFT EYE COMPLETELY THE MORNING OF 2/15/21.
36 2021-02-22 muscle spasms, numbness Adverse events: cramping at injection site (deltoid), cramping in injection arm, general body crampi... Read more
Adverse events: cramping at injection site (deltoid), cramping in injection arm, general body cramping, muscle spasms, numbness, body temperature dropping, high fever (101F), chills, severe headache, excessive sweating, severe earache, lethargy, loss of appetite, loss of balance, dizziness, vertigo, joint pain (knees), altered sense of smell (acidic smoke), altered sense of taste (metallic), altered color vision (tinted yellow), altered mouthfeel (plastic film feeling), gum sensitivity, blotchy rashes (legs), tightness in chest, difficulty breathing. All occurred within first 48 hours following injection and began to subside without intervention prior to 72 hours following injection.
36 2021-02-22 pain in extremity Arm Soreness and stiffness, Headache (the patient took Tylenol)
36 2021-02-28 muscle spasms Joint pain throughout body followed by spasm in my lumbar region. This is the first spasm I've had s... Read more
Joint pain throughout body followed by spasm in my lumbar region. This is the first spasm I've had since I got the spinal cord stimulator implanted over a year ago.
36 2021-03-02 burning sensation, tingling Tingling burning in all extremities, trunk and face; Tingling burning in all extremities, trunk and ... Read more
Tingling burning in all extremities, trunk and face; Tingling burning in all extremities, trunk and face; weakness in all extremities; Shortness of breath with after completing one flight of stair.; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for himself. A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included high blood pressure (BP), ocular migraine. Concomitant medication included amitriptyline, amlodipine. The patient received first dose of BNT162B2 on 02Jan2021 4:00PM for Covid-19 immunization and expedited tingling in right 15 days first dosage. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Tingling burning in all extremities, trunk and face after second dosage. Tingling and burning was followed by weakness in all extremities including Shortness of breath with after completing one flight of stair. Visited primary care physician and blood work results were not significant for any abnormalities. Visited emergency room (ER) and was seen by neurologist who did think symptoms were severe. Awaiting EMG scheduled for 24Mar2021. No treatment received for the events. 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 not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect drug administration to 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 2021-03-03 bell's palsy Bells Palsey
36 2021-03-03 unresponsive to stimuli, seizure Was administered the Pfizer COVID-19 vaccine in our drive-thru clinic on 3/4/21 at approximately 2:1... Read more
Was administered the Pfizer COVID-19 vaccine in our drive-thru clinic on 3/4/21 at approximately 2:15pm. Was in the driver's seat of his SUV with his father in the passenger seat. Nothing in the PQCF gave us any reason to be concerned over this particular administration. After administration, was asked to pull forward and park in a spot on the right in order to sit for his required 15 minutes post-administration. became unresponsive as he was attempting to park and continue to turn the wheel causing him to drive in a U shape into a rock covered median. The SUV was able to clear the median and the car stopped at the APEX. When I saw the car heading towards the median, I started to head toward the site safely. I approached the car slowly asking him to stop. When I did not receive a response, I knew something was wrong. Once I felt the car was safe to approach, I ran to assist the patient. The patient was barely able to communicate but did say he was dizzy. 15 seconds later he was unable to communicate, I called a second pharmacist to run over with an epi pen just in case (this was NOT administered). I immediately called 911 at 2:21 pm. reached into the vehicle and got the vehicle into park, while I assessed his airway, breathing, and pulse from a seated position. The patient began to seize. I continued to hold the patient from outside of the vehicle to maintain the patient's airway and keep him from hurting himself on the steering wheel. The patient regained consciousness approximately 3 minutes later with no memory of what happened. EMS arrived on scene about 2 minutes after he regained the ability to communicate. While EMS assessed the patient, and I reached out to and division one store management per SOP. EMS determined that the patient had a seizure and was able to go home if they wanted. The father moved into the driver seat. We monitored the patient for 30 minutes and allowed them to leave. We followed up with the patient via phone 2 hours later with no concerns noted. No property damage or bodily harm occurred during this incident. If we are given approval to vaccinate this patient with a second dose, we will arrange for this patient to be taken care of in the pharmacy.
36 2021-03-07 feeling hot Patient received dose 1 of Pfizer cov-19 vaccine. Approximately 10 minutes after administration, te... Read more
Patient received dose 1 of Pfizer cov-19 vaccine. Approximately 10 minutes after administration, team member began to report that he did not feel well. He was hot, then cold, felt nauseous and very dizzy. He vomited 3 times. We called 911 immediately. I monitored patient's breathing until emergency personnel arrived. EMT determined that situation was not life threatening. Patient left with his wife and stated he was heading to urgent care clinic.
36 2021-03-07 seizure Patient received 2nd dose of Pfizer COVID vaccine approximately 1:00pm. Around 1:15 pm staff were al... Read more
Patient received 2nd dose of Pfizer COVID vaccine approximately 1:00pm. Around 1:15 pm staff were alerted by patient's father that he was having a seizure in the car. Staff went to assess situation, no seizure activity was noted at that time. Patient was lying on his left side in the back of truck, vomit present on truck seat and in patient's nares. Patient has a history of epilepsy. Pulse ox was 78 and HR was 136, and there was concern for aspiration. Pt was placed on oxygen while waiting on ambulance. Oxygen sat improved up to 94% on 4L of oxygen, HR continued in 130s. He was stable when ambulance arrived approximately 15 minutes later, and he was transferred to the hospital.
36 2021-03-12 bell's palsy Bell's palsy left side. Medicine: Prednisone20mg 1 tablet a day for 5 days Acyclovir 800mg 1 tablet ... Read more
Bell's palsy left side. Medicine: Prednisone20mg 1 tablet a day for 5 days Acyclovir 800mg 1 tablet 4 times a day for 10 days Ibuprofen 600mg 1 tablet every 6 hours
36 2021-03-13 numbness Day 1 - flu like illness Day 2 7 pm acute onset numbness R jaw and neck pain - seen in UC and sent t... Read more
Day 1 - flu like illness Day 2 7 pm acute onset numbness R jaw and neck pain - seen in UC and sent to ER for evaluation of acute stroke symptoms - serial neuro exams normal
36 2021-03-14 seizure, feeling hot approximately 3-5 minutes after receiving dose, client states he felt a surge of warmth rush over hi... Read more
approximately 3-5 minutes after receiving dose, client states he felt a surge of warmth rush over him. Client loss consciousness and fell out of his chair. Client was laying prone with both arms down by his sides. Assume client hit his head when he fell. After approximately 10-20 seconds, client awoke, confused as to what happened, but oriented to person, place, and time. Client remains pale and diaphoretic. Client sat for 3-5 on the floor, recovering, then moved client to a wheelchair to escort him to the medical eval area. Upon transport to eval area, client stated he felt it happening again. He then fell unconscious again, with is head falling forward, client panic. Started to seize with body going stiff and sliding out of wheelchair. 4 staff assisted client safely to the floor, placing a blanket under his head. Approximately 10 seconds of so activity and client awoke again confused as to what happened, but oriented to person and place. Client had bladder inconvenience. 911 called at 1854. BP 130/84, stats 97%, HR 70 s, breathing non labored, 16-20 breaths per minute. Report given to EMTs. After 10 minutes client moved to chair. Vitals remain stable. After 20 minutes client stood up and walked around. Taking water and crackers. Color is better. Client refused ambulance to the ER. Called his friend, an RN, who will take him home. Client encouraged to stay with a friend if he chooses not to go to the ER. Also encouraged client to talk to his provider before receiving his 2nd dose.
36 2021-03-15 tingling, numbness After 8-10min of vaccination I felt the entire right arm heavy, and with a tingling sensation. The l... Read more
After 8-10min of vaccination I felt the entire right arm heavy, and with a tingling sensation. The lower right hand side of my neck, right check and lip felt slightly numb with tingling sensations. The side effects lasted approximately 15-20min.
36 2021-03-15 tingling Patient fainted and ended up falling and hitting her head on the floor. Once she came to, she felt "... Read more
Patient fainted and ended up falling and hitting her head on the floor. Once she came to, she felt "tingling" and ended up breaking into a sweat.
36 2021-03-15 tingling Patient notified me shortly after receiving his vaccine he had onset of "painful tingling throughout... Read more
Patient notified me shortly after receiving his vaccine he had onset of "painful tingling throughout body" and erythema of his hands. Denies chest pain, SOB, difficulty breathing, headaches, dizziness, swelling of lips/tonge/throat, itching or rash. No prior history of any allergic reaction. PMH significant for COVID-19 3/20. BP 125/88, HR 78, O2 sat 98% RA. After 45 minutes of observation - patient states he is feeling much better, mild erythema of the hands resolved. Denies any new symptoms, repeat vitals 122/89, HR 81, O2 sat 97% RA. Patient states he feels comfortable to go home. Informed patient if he has onset of SOB, chest pain, swelling of lip/tongue/throat, dizziness, or any other symptoms of distress. Reviewed common side effects of vaccine which may have onset tomorrow and supportive measures. Patient verbalized understanding and had no further questions or concerns at this time.
36 2021-03-15 tingling Patient appeared to experience vasovagal syncope within 30-60 seconds of injection. Patient briefly... Read more
Patient appeared to experience vasovagal syncope within 30-60 seconds of injection. Patient briefly lost consciousness for approximately 30 seconds and complained of severe nausea following the incident. After recovering, he stated that he has a history of vasovagal syncope and usually receives injections lying down. He described tingling sensation of hands and feet, nausea, and was perspiring. Patient had gatorade and water and tried to eat crackers before complaining again of nausea. Observed him for about 20 minutes at which point he was still complaining of nausea but was able to ambulate unassisted and left with his nurse wife. Checked in with him three hours later and he stated that he was feeling better.
36 2021-03-15 seizure Pt received the covid vaccine around 12:50 pm. Then as he was walking to schedule his second appoin... Read more
Pt received the covid vaccine around 12:50 pm. Then as he was walking to schedule his second appointment soon after the vaccine, he fell to his knees (no CHI). I was notified and ran over to see pt was disoriented, pale, diaphoretic. While measuring his left arm BP (80/30), he began to convulse with both elbows flexed. The convulsions lasted about 10 secs, pt did not recall the event, we held him in a seated position on the floor. He felt much better after the convulsion + water/snacks, however we did call EMS during the event. Per EMS, BP was 128/80, and pt was AAOx3. Pt refused to go to the hospital and agreed to f/up with PCP.
36 2021-03-16 flushing Systemic: FAINTING - LOSS OF CONSCIOUNESS FOR A FEW SECONDS AND HIT HIS HEAD. BITTED HIS TONGUE.-Med... Read more
Systemic: FAINTING - LOSS OF CONSCIOUNESS FOR A FEW SECONDS AND HIT HIS HEAD. BITTED HIS TONGUE.-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: PARAMEDICS CAME. HE WAS FEELING MUCH BETTER. HE WAS RESPONSIVE.
36 2021-03-16 tremor Sore throat within 24 hours of shot and uncontrollable shaking that lasted about 10 minutes after 2... Read more
Sore throat within 24 hours of shot and uncontrollable shaking that lasted about 10 minutes after 24 hours from shot. Headache and extreme fatigue 12-36 hours after shot. Muscle soreness in both arms after 24 hours of shot.
36 2021-03-17 feeling cold, cold sweat Dizziness, nausea, clamminess after ~15-20 minutes. Patient laid down with feet elevated. Dizziness,... Read more
Dizziness, nausea, clamminess after ~15-20 minutes. Patient laid down with feet elevated. Dizziness, nausea went away after 10 minutes of laying down. Patient started to feel cold, had shivers, and complained of heart palpitations or heart feeling like it was skipping a beat.
36 2021-03-17 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
36 2021-03-17 tingling Pt received vaccine and within ~2 minutes started feeling woozy and reported tunnel vision. He aler... Read more
Pt received vaccine and within ~2 minutes started feeling woozy and reported tunnel vision. He alerted his nurse who called for back up. Upon arrival, patient appeared pale and diaphoretic. Pt appeared lethargic but was conscious. Pt moved via stretcher to observation unit at 1601. Pt denied SOB, dizziness, palpitations, rash, itchiness, swollen mouth/tongue. Pt reported he had vasovagal response to another vaccine (tetanus) before. Vitals: 1605 154/108, 95%, 77HR 1608 146/90, 95%, 76 HR 1620 138/90, 95%, 76 HR At 1622 pt reported feeling 'tingly'. lungs clear on auscultation. Occasional PVCs on auscultation. Pt reported history of palpitations. 1636 151/102, 99%, 80 HR Pt reported palpitations subsided and tingling feeling subsided. 1635 141/94, 99%, 75 HR Pt escorted via wheelchair out of facility with a stop at the bathroom and was advised on follow up for additional care should palpitations return or s/s of allergic reaction.
36 2021-03-17 tremor Fever, chills like I?ve never get before. I was trembling. My fever was 103, I took an ice cold show... Read more
Fever, chills like I?ve never get before. I was trembling. My fever was 103, I took an ice cold shower to combat it. My headache was horrible and I think i was very dehydrated. I drank water but I kept urinating as if I couldn?t hold any water in. My watch warned be for an hour long period that my heart rate was 120+ when i was laying down with the chills.
36 2021-03-17 unresponsive to stimuli Pt. Found unresponsive in observation chair. Attempted sternal rub. Pt. Unconscious ~ 30 seconds, di... Read more
Pt. Found unresponsive in observation chair. Attempted sternal rub. Pt. Unconscious ~ 30 seconds, disoriented when finally awoke. Within 1-2 minutes, pt. was able to be re-oriented. EMS called. Pt. Became diaphoretic, stating that he was having a hard time getting air. Pt. Placed on 6L non-rebreather. Pt. Transferred to stretcher without issue. Pt. Able to have normal conversation. Per pt, he often faints when having blood drawn. Pt. Only ate a banana prior to getting his vaccine, pt. Normally has a more robust breakfast. After EMS arrival, VS remained stable. Per EMS BG normal. EMS attempted to get patient to sit up, pt again became increasingly diaphoretic and less responsive/drowsy. Pt. Stated he felt dizzy and was seeing white spots. Pt. Transferred to EMS stretcher and taken to ED. 1009: HR 56, RR 18, BP 129/83, SpO2 93% 1015: HR 59, RR 20, BP 115/80, SpO2 98%
36 2021-03-18 inability to speak Became very fatigued around 3 hours after vaccine, then had to lay down where I was, within 30 minut... Read more
Became very fatigued around 3 hours after vaccine, then had to lay down where I was, within 30 minutes could not speak or move any part of my body. Brought to emergency room where I was put on an IV and had blood test to show that my CK levels where at 7357 (normal range is 24-200). Slowly regained ability to move and speak over a 6 hour period at the ER, then transferred for hospitalization and further tests. Spent the next 4 days on IV, slowly flushing down my CK level, until discharge on 3/19 at CK = 3054.
36 2021-03-18 discomfort developed episodic HA. "Feels like a pressure in my head." Travels from one spot to another. Episodi... Read more
developed episodic HA. "Feels like a pressure in my head." Travels from one spot to another. Episodic. Lasts for several minutes before spontaneously resolving.
36 2021-03-18 pain in extremity Headache, sore arm
36 2021-03-21 numbness C/o of left hand and forearm numbness
36 2021-03-22 weakness, feeling hot Stronger pain in area of shot (compared to first dose) Soreness About 14-15 hours after the 2nd dose... Read more
Stronger pain in area of shot (compared to first dose) Soreness About 14-15 hours after the 2nd dose, I began feeling extremely fatigue. Also developed a slight chills feeling. At the 21 hour mark, I was exhausted. Felt very weak and stared feeling a little warm. Around hour 22/23, body/bone aches developed. By 24hrs after the 2nd vaccine, I took 800mg of ibuprofen (to help with the body aches and slight fever) and a Zyrtec for my allergies. I'm awake and getting ready for work again (I worked through the symptoms yesterday, somehow) approx 34hrs after the 2nd dose. I feel "normal" considering my arm is still sore from the shot. But all other symptoms appear to have subsided; my only tiredness is from waking up early for work.
36 2021-03-22 muscle twitching Sitting down on bleachers immediatly after receiving COVID vaccine - started feeling lightheaded and... Read more
Sitting down on bleachers immediatly after receiving COVID vaccine - started feeling lightheaded and had a witnessed syncopal episode. Patient hit his head on the back of the bleacher and passed out for a few seconds. Reports twitching movements. Reportedly does have a history of passing out with injections and piercings in the past. He had not had anything to eat or drink that day.
36 2021-03-23 hot flush Hypotension, syncopal like episode, hot flash, and diaphoresis
36 2021-03-24 discomfort Felt off, about one hour after receiving vaccine. Cognitive fatigue, seven hours after vaccination. ... Read more
Felt off, about one hour after receiving vaccine. Cognitive fatigue, seven hours after vaccination. Body discomfort/muscle aches 3:30am next day. On waking at 8:00am, physical and mental fatigue, full-body ache, sore arm, more difficult to lift, at injection site. Felt very much like having flu.
36 2021-03-25 feeling hot, feeling cold Mild headache approx 4 hours after injection. When waking to alarm at 0600 on 25Mar21, noticed that... Read more
Mild headache approx 4 hours after injection. When waking to alarm at 0600 on 25Mar21, noticed that bed was wet from sweating. Foread was hot to the touch, ague, severe headache, light and noise sensitivity. The room was cold, I turned up the heat in the house and put on sweatpants, socks, thermal shirt, hoodie, and beanie and could not get warm. Began drinking water (1.5 gal by end of day at 2300). No appetite for the entire day, nausea set on after eating a bowl of oatmeal around 1030. Had several episodes of dry heaving, but no vomiting after eating. Ate again at around 1900 - chicken broth and a peanut butter sandwich, nausea set on at around 1945, dry heaving, but no vomiting. Spoke with PCM on symptoms and continued to monitor. On 26 Mar21, cold sensation had abated, continued drinking water. Headache, light sensitivity, nausea, and body aches for the entire day, headache has remaind constant - 6 out of 10. Nausea at a 4. Body Aches varied between 4-7. Around 1100, I noticed that my neck had stiffened and it felt as if I had a tension headache. I used a theracane, heat, and an ice pack to try and relieve the tension with no success. I have tried relaxation techniques learned from VA to manage pain with no success. As of 2146, stiffness is around a 6, headache is a 7, body aches 3, nausea while sitting 1, while walking 4.
36 2021-03-25 flushing, feeling hot Onset began with a flushing/warmth feeling in the right side of face about 35 minutes after injectio... Read more
Onset began with a flushing/warmth feeling in the right side of face about 35 minutes after injection, with itching on the roof of the mouth accompanied by feeling of swelling in the area. This was followed by a spread of the flush/warm feeling across the face, chest and arms followed immediately by a 2-3 minute panic feeling, chest tightness and extremely heightened anxiety with a general feeling of being unable to focus/concentrate. After this couple of minutes the flushing stopped in all areas except the cheeks and the itching sensation dissipated quickly over the next 30 minutes but the feeling of swelling on the roof of the mouth continued for a total of one hour. There were no visible signs of swelling in the mouth, tongue or throat, nor redness in the face. The flushing feeling settled in both cheeks of the face and was accompanied by heightened anxiety, along with an overall feeling of being warm. However, there were no visible signs of redness or rash, the sensations and anxiety persisted for mildly for 10 hours, all of which gradually dissipating over time. That night physical symptoms had cleared up, soreness in the right arm began and lasted into the morning. Anxiety levels mostly returned to normal in the morning.
36 2021-03-26 tingling, feeling hot Pfizer COVID-19 Vaccine EUA Patient became sweaty and hot and felt like his right arm was tingling ... Read more
Pfizer COVID-19 Vaccine EUA Patient became sweaty and hot and felt like his right arm was tingling got to the medical obs. Patient was monitored for a total of 30 minutes. Patients vital remained stable. Reported improvement in symptoms prior to being discharged.
36 2021-03-27 flushing Approx 15 minutes post vaccine patient sts he feels flushed with no other symptoms. 25 minutes post ... Read more
Approx 15 minutes post vaccine patient sts he feels flushed with no other symptoms. 25 minutes post vaccine pt sts feels like it's hard to swallow, tongue is swollen and throat itches. Alert, oriented. No rash or swelling to face or neck noted. Tongue did not appear swollen. No shortness of breath. Pt appears anxious. Reports no pain. BP 110/palpation, HR 73, RR 20 oxygen sat 96%. EMS notified. Pt declined transport but may have been transported to the local hospital, of the . Unknown if wife drove him. Pt stated he wanted to go home to take some Benadryl which he takes for seasonal allergies.
36 2021-03-28 pain in extremity 1st shot was Thursday night. Started getting a stomach ache before dinner Friday, didn't get better ... Read more
1st shot was Thursday night. Started getting a stomach ache before dinner Friday, didn't get better after eating, felt very nauseous the remaining of the evening. About an hour or two after nausea started, felt very tired. Slept fine Friday night, woke up Saturday and stomach ache was gone, but tired all day Saturday. Sunday I felt normal. I also had a sore right arm Friday and Saturday.
36 2021-03-28 tingling, muscle spasms upon injection, immediate dizziness and slightly faint along with weird tingling and weakness feelin... Read more
upon injection, immediate dizziness and slightly faint along with weird tingling and weakness feeling in hands and feet. Had mild headache and mild arm ache which went away after 2 days, no fever, site redness, no chills. It has now been 10 days and I still have tingling and weakness mainly in hands and feet but sometimes it spreads to calfs, thighs, and arms. It feels like the beginning stages of a charlie horse about 25% of the time and I am getting 1 to 2 charlie horses each day.
36 2021-03-29 cold extremities Extreme fatigue. I?ve been sleeping double my normal amount of hours each day and still feel like I ... Read more
Extreme fatigue. I?ve been sleeping double my normal amount of hours each day and still feel like I need more sleep. Body temperature feels high although my skin feels cool to the touch
36 2021-03-29 seizure The day after the 2nd dose of COVID19 vaccination series this person had a seizure while at work. E... Read more
The day after the 2nd dose of COVID19 vaccination series this person had a seizure while at work. EMS was called and he had another seizure for them before they could transport him to the hospital. He also had a fever38.6. The individual was admitted and overnight became increasingly agitated and confused. Family reports that that after discharge from the hospital he has not returned to his normal functioning. Prior to this episode he was living alone and working. Now he cannot be left alone as his neurological status has quite deteriorated . He has had a ?substantial disruption of the ability to conduct normal life functions? Family have had to take time off of work and make arrangements to care for him.
36 2021-03-30 cold sweat nausea & feels "faint" Cool & calmmy. TX - mask removed. laid pupine across truck seat - incr... Read more
nausea & feels "faint" Cool & calmmy. TX - mask removed. laid pupine across truck seat - increased legs. O Sat increased B/P 134/92. given H2O symptoms abated. after additional 15 mins wait time. felt "good" & drove off lot.
36 2021-03-30 flushing At first I just started to feel a little nausea and some dizziness. Later my face and top of my hea... Read more
At first I just started to feel a little nausea and some dizziness. Later my face and top of my head and upper chest flushed some and had a headache, the headache went away on it's own relatively quickly. The next day I felt a little rough, but I have read that the second dose has much higher side effects, and since I have a blood issue, it's concerning.
36 2021-04-01 flushing Flushing/sweating. Blood pressures 148/84 (pulse 81), 141/84 (pulse 78). O2 sat 97%.
36 2021-04-01 trigeminal neuralgia 1. Mild fever, 3/29 evening treated with Tylenol. Subsided 2. Trigeminal neuralgia, started 4.00 pm ... Read more
1. Mild fever, 3/29 evening treated with Tylenol. Subsided 2. Trigeminal neuralgia, started 4.00 pm on 3/29. Ongoing. Treating with carbamazepine and ibuprofen.
36 2021-04-02 feeling hot, cold sweat Admin saw patient was fanning himself and said he was "dizzy and hot temp". EMT and staff assisted. ... Read more
Admin saw patient was fanning himself and said he was "dizzy and hot temp". EMT and staff assisted. 1:21 pm. EMT laid patient flat on floor with legs elevated Patient was awake, alert x 3, cool to touch, pale, diaphoric, vital signs, BP 190/110, HR 108, O2 Sat 98%, RR 18, Blood sugar 119, Temp 97.3. Ice pack was applied. Patient tolerated sips of water well with no problems. 1:33 pm, EMT reassessed: BP 140/90, HR 98, SaO2 99%, RR 14. Patient was able to sit in the chair and stated he was feeling better. With further 30 mins observation, Patient said he was doing fine and his wife was here to drive him home. Staff, EOA, RN discharged patient to parking lot.
36 2021-04-03 feeling hot I was unable to sleep and began to feel significantly overheated by 10 or 11pm the night of my vacci... Read more
I was unable to sleep and began to feel significantly overheated by 10 or 11pm the night of my vaccination. To give a sense of the extent of the disturbance, I ended up standing outside for 10 minutes without shoes or socks in the cold night air (~45°F) to cool off, but remained shiftless the rest of the night and was unable to remain asleep for a full sleep cycle until early morning (4 or 5am). I did not take my temperature at any point but did not appear to have a significantly warm forehead. The next morning I woke up with a very sore left shoulder and arm (i.e. the site of my vaccination) and general muscular stiffness in my back. Raising my arm increases the soreness significantly. I have no concerns about my reactions, but they were significant for a first Pfizer COVID shot so I am reporting to provide information to VAERS.
36 2021-04-03 pain in extremity Minor to light pain to the touch at the injection site approximately 30 minutes after injection, acc... Read more
Minor to light pain to the touch at the injection site approximately 30 minutes after injection, accompanied by minor to light soreness in the left arm. Symptoms gradually intensified throughout the day. I started to feel generally fatigued a couple hours following injection. Approximately eight to ten hours post-injection, injection site had fair pain to the touch, but no redness or other discoloration was noted. Moderate soreness in the left arm. I felt very fatigued. No pain medication was taken, I just slept for approximately nine hours. When I woke up before 0700, the arm soreness and pain at the injection site had lessened to mild soreness and minor to light pain at the injection site, but I still felt fatigued. I decided to power through and go to work, and the fatigue had subsided in hours. No further issues.
36 2021-04-04 flushing Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: ... Read more
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Patient had BP taken and it was normal, continued to be dizzy after 30-45 minutes of sitting. He had to sit on the floor. EMS was called and monitored him. Nothing further was reported
36 2021-04-04 mild one side paralysis, tingling, cold extremities 4/2/21 Patient calling and states he received the 1st covid vaccine, Pfizer, on the 3-29-21 at 12:07... Read more
4/2/21 Patient calling and states he received the 1st covid vaccine, Pfizer, on the 3-29-21 at 12:07 pm. The patient is having left side rib pain with left axillary pain that travels down the chest. Pain also in the left arm in the injection with shoulder pain all the way down to the elbow. The left hand and the left foot feel cold and tingling. The left sinus cavity feels cold with numbness. The side of the neck feels swollen, unsure. My heart is racing?weakness on the left side of the body. The patient had covid previously. The patient went to ED 4/2/21- diagnosis of Paresthesia of left arm and leg.
36 2021-04-06 night sweats The lymph nodes in my left underarm became very enlarged and very sore and painful for 5-6 days. I a... Read more
The lymph nodes in my left underarm became very enlarged and very sore and painful for 5-6 days. I also had flu like symptoms and severe night sweats while asleep.
36 2021-04-06 pain in extremity Had an extremely sore arm the next day after the shot. Nine days after first shot, in the afternoon ... Read more
Had an extremely sore arm the next day after the shot. Nine days after first shot, in the afternoon suddenly started feeling faint, dizzy/vertigo, fatigue, and heart palpitations strong enough to make me cough from the pressure drop.
36 2021-04-06 seizure, tremor Involuntary shaking/convulsions/shivering across entire body. Was able to walk, but very difficult ... Read more
Involuntary shaking/convulsions/shivering across entire body. Was able to walk, but very difficult going up/down stairs. No fever nor did I feel cold. Shaking subsided after about 15 minutes.
36 2021-04-06 seizure I had a seizure around 5 minutes after the shot. I was feeling sweat and my vision started to fade..... Read more
I had a seizure around 5 minutes after the shot. I was feeling sweat and my vision started to fade...I can explain further on a call or email.
36 2021-04-07 numbness, tingling Numbness and tingling in arm, neck and face
36 2021-04-07 pain in extremity Left Arm pain occurred 2 hours after receiving shot headache occurred 15 hours after receiving shot ... Read more
Left Arm pain occurred 2 hours after receiving shot headache occurred 15 hours after receiving shot tiredness occurred 4 hours after receiving shot vomiting 13 hours after receiving shot
36 2021-04-08 flushing About an hour after receiving vaccine I had the following take place: Flush skin, sweating (no fever... Read more
About an hour after receiving vaccine I had the following take place: Flush skin, sweating (no fever), stiffened muscles in neck and shoulders, tingling / stiff tounge, and enlarged lymph nodes in neck. Started taking over the counter benadryl (every 4 hours) until I could get in to see my doctor. Flush skin and sweating subsided, but stiffened muscles and swollen lymph nodes persist.
36 2021-04-08 tingling tongue stiffness, tingling, skin tingling, lymphadenopathy, muscle stiffness
36 2021-04-08 sciatica, numbness The evening he received his 1st dose of the vaccine, he developed severe sciatica in his left leg. ... Read more
The evening he received his 1st dose of the vaccine, he developed severe sciatica in his left leg. He took tylenol and ibuprofen and did gentle stretching. Then 4/2 he sought care because the pain was worse. He was prescribed a steriod-prednisone-unsure of doseage. He was also given a shot of Tordal. He did ok the next 3 days and was alble to walk around. He did have numbness in last 2 toes of left foot, in arch and on the inside of left foot. He called the provider on Monday 4/5 and was given Diclofinac. He saw Dr. on Thursday 4/9 and had an xray which did show narrowing of L5 through S1. Today, he has a consult with neuroscience APNP, for a consult.
36 2021-04-09 pain in extremity Sore arm, bad taste in mouth, Nashua, dizziness, body aches, fever
36 2021-04-09 pain in extremity Pain in left arm; chills; fever of 100 degrees; This is a spontaneous report from a contactable cons... Read more
Pain in left arm; chills; fever of 100 degrees; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received first dose of BNT162B2 (Pfizer- BioNTech COVID 19, solution for injection, lot number: unknown) via an unspecified route of administration on 05Feb2021 at 02:30 PM on left arm as single dose for COVID-19 immunization. Patient had other Medical history included Known allergies. Concomitant medications was not reported. 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 06Feb2021 at 02:00 PM Patient experienced pain in left arm, chills and fever of 100 degrees after vaccination. No treatment was given. Outcome of the event was not recovered. Information on the lot/batch number has been requested.
36 2021-04-11 tingling I started experiencing chest pain when I woke up. Also, right foot and arm were tingling. This is fr... Read more
I started experiencing chest pain when I woke up. Also, right foot and arm were tingling. This is from the second dose of the Pzifer Vaccine.
36 2021-04-12 burning sensation On 2/19/2021 I started getting a rash hand. It work its way up to the elbow. Then it started to appe... Read more
On 2/19/2021 I started getting a rash hand. It work its way up to the elbow. Then it started to appear also on my right arm. It was very itchy, burning sensation, & very red. It looked like scabies but it was not that. I followed up with my doctor and he prescribed me Hydrotoxin & prednisone. Also had a little bit of nausea.
36 2021-04-13 tremor, feeling hot, feeling cold This patient was vaccinated with the vaccine at approx 1530, in the left arm. He was sitting in the... Read more
This patient was vaccinated with the vaccine at approx 1530, in the left arm. He was sitting in the observation area for his allotted 15 minutes. At approx 1540 this nurse was called over by a staff member and was told that this patient was feeling dizzy, hot and nauseous. This patient presented as diaphoretic and pale. RN's, came over to the patient and began asking basic demographic info questions, and started to measure his vital signs. This patient denied any heart issues or past medical history. His father was present and was seated next to the patient. We had the patient move onto a cot and we had the patient lay down and we elevated his feet. The patients initial vital signs were: 110/70, HR 56 and O2 99% at 1543. He stated that he felt some shortness of breath but was able to speak to us without difficulty. No wheezing or rhonchi present. We kept the patients legs elevated and provided a cold pack to his head and neck. After approx 10 minutes the patient stated he felt better, but he felt cold and his legs and upper body were shaking. Once we sat him up into a sitting position he stated he wasn't feeling dizzy. We kept him there for another 10 minutes until he felt better. His vital signs were measured again and his bp was 140/90, HR 91 and O2 level was 99%. The patient denied any difficulty breathing. This nurse advised for the patient and his father to go to the Emergency Room if another episode of this occurs. The patient understood and he walked with his father to their car without any difficulty.
36 2021-04-14 feeling cold Approximately 45 minutes after returned to site w tachypnea, low grade temp 100 degrees, normal 98% ... Read more
Approximately 45 minutes after returned to site w tachypnea, low grade temp 100 degrees, normal 98% O2 sat, and recurrent moderate rigors that waxed and waned. Hemodynamically stable w tachycardia, cool extreme and diaphoretic. No rash, rigor, airway compromise. Transferred to ER by ambulance.
36 2021-04-15 tingling, numbness c/o numbness/tingling on left arm and body 14 mins post vaccination, vital signs within normal, wor... Read more
c/o numbness/tingling on left arm and body 14 mins post vaccination, vital signs within normal, worked up at ambulance. Initially agreed to be transferred via ambulance to hospital then changed his mind and preferred to go home instead. Discharged home with instructions to call 911 if sypmtoms return or worsen.
36 2021-04-16 numbness Right arm and upper body became numb. Redness and bruising appeared around injection spot with clea... Read more
Right arm and upper body became numb. Redness and bruising appeared around injection spot with clear liquid forming around skin
36 2021-04-16 pain in extremity Major swelling in both feet, ankles, and calves. Swelling subsided after a few days, but there is st... Read more
Major swelling in both feet, ankles, and calves. Swelling subsided after a few days, but there is still pain in the toes and ankles whenever I sit down
36 2021-04-18 burning sensation, tingling With in 30 minutes I began to have trouble swallowing liquids. Within 2 hours i felt like there were... Read more
With in 30 minutes I began to have trouble swallowing liquids. Within 2 hours i felt like there were needles puncturing my whole body or a really horrible sun burn.
36 2021-04-18 cold sweat Patient received vaccine at approximately 1230, started to feel lightheaded, dizziness, and nausea.... Read more
Patient received vaccine at approximately 1230, started to feel lightheaded, dizziness, and nausea. Patient was pale, diaphoretic, and clammy at point of observation. Patient was brought to observation POD. Patient stated his blood pressure was abnormal. Initial blood pressure was 173/120 with HR of 72. Patient stated he was prescribed lisinopril and hydrochlorothiazide, however, has not taken medication in a month because he felt his "blood pressure was fine". EMS was notified. Blood pressure on recheck was 168/110. Patient was evaluated by EMS, patient had been driven by escort. Patient declined visit to hospital transport with EMS. ER precautions were given and patient was notified to f/u with primary care provider in regards to incident.
36 2021-04-18 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
36 2021-04-18 seizure 10 min post vaccination patient became unconcious With clear signs of siezure *Incontinence *Cyanosi... Read more
10 min post vaccination patient became unconcious With clear signs of siezure *Incontinence *Cyanosis with postictal *headache *nausea *drowsiness *Airway management 30-60 sec *Tireness *Sleeppy *presentacion PT required
36 2021-04-19 brain damage Patient presented to outlying hospital on 3/31 for a 4 day history of nausea, vomiting, and confusio... Read more
Patient presented to outlying hospital on 3/31 for a 4 day history of nausea, vomiting, and confusion. Blood pressure in the 200s. Admitted for hypertensive urgency, renal failure, encephalopathy. By 4/3, patient was agitated and unable to recognize anyone but his mother. Fever 102.1. Intubated on 4/5 as he continued to worsen and responded only to painful stimuli. Patient transferred on 4/5. MRI demonstrated mutlifocal bilateral cerebral infarcts with vasogenic edema. Small infarct in the left cerebellar hemisphere. All workups so far have been negative. TEE being performed 4/20 to evaluate possible cardiac embolic source. Providers are unsure of etiology of infarcts and edema. Reporting per infectious disease physician's request.
36 2021-04-20 cold sweat Pt was found pale, diaphoretic and clammy, no LOC. Assisted to recumbent position on floor with BLE... Read more
Pt was found pale, diaphoretic and clammy, no LOC. Assisted to recumbent position on floor with BLEs elevated on chair. VS as follows: BP 109/70, HR 60, sats 94% on RA. Pt given water, snacks, cold compress applied. Pt was assisted to seated position after 3-5 mins, VS as follows: BP 115/74, HR 70, sats 96% on RA. Pt recovered within 10 mins and ambulated out of clinic in NAD after 20 min observation period.
36 2021-04-20 tingling, numbness PATIENT REPORTED NUMBNESS AND TINGLING FEELING IN LEFT LOWER JAW APPROXIMATELY EIGHT MINUTES AFTER R... Read more
PATIENT REPORTED NUMBNESS AND TINGLING FEELING IN LEFT LOWER JAW APPROXIMATELY EIGHT MINUTES AFTER RECEIVING HIS VACCINE. PATIENT REPORTED NO DIFFICULTY BREATHING, OR ANY OTHER SYMPTOMS. PATIENT WAS GIVEN DIPHENHYDRAMINE 50MG AT 12:30PM. PATIENT STAYED FOR AN ADDITIONAL TEN MINUTES, AND REPORTED THE FEELING STAYED THE SAME. FOLLOWED UP WITH PATIENT ON APRIL 21, PATIENT REPORTS THE FEELING WENT AWAY AFTER A FEW HOURS.
36 2021-04-21 weakness Fever, headache, chills, body ache, weakness
36 2021-04-21 pain in extremity During the evening on the day after my 2nd dose I experienced a fever up to 100.9 and when I woke up... Read more
During the evening on the day after my 2nd dose I experienced a fever up to 100.9 and when I woke up the following morning my arm was more than sore like the day before. I softball size raised red spot surrounded the injection site (slight off center, a bit lower where the injection site is more at the top of the softball sized spot). The injection site was very itchy, and the large red spot was hard, raised, and itchy. I looked up what this was and saw that is was extremely similar to "COVID Arm" and saw that is was atypical, but ok and that it should go away in a couple days to weeks. Which it did, at this point I feel a slight sore tingle around the injection site, but no more red spot or itchiness.
36 2021-04-22 discomfort I felt like my stomach was going to explode the day after getting the vaccine. The amount of pressu... Read more
I felt like my stomach was going to explode the day after getting the vaccine. The amount of pressure in my belly, it felt like something was going to burst. I was able to throw up 5x, which relieved some pressure, but I was still very uncomfortable. Yesterday and Today (Day 3 & 4 post vaccination shot), I have been monitoring the pain in my stomach, and the pain has traveled to the lower-right portion of my stomach. I am afraid my appendix is going to burst. I?m going to see a Dr today. I believe this is very unfair to me, an essential employee, who never contracted Covid-19 while still attending work over the last year, I was encouraged to take the vaccination shot by the state and my employer, and now I?m afraid I will need surgery. Please look in to this.
36 2021-04-22 pain in extremity Sore Arm for approximately 24 hours
36 2021-04-23 cold sweat, night sweats, pain in extremity Severe chills, cold sweats, temp 99.4, lethargy in whole body, left arm so sore unable to move on i... Read more
Severe chills, cold sweats, temp 99.4, lethargy in whole body, left arm so sore unable to move on it?s own power, pain and chills and cold sweats so severe I couldn?t sleep more than 1 or 2 hours at a time. Wake up drenched in cold sweats every 2 hours, all night long. Side effects from dose 1 - mildly sore L arm for 18 hours. Side effects from dose 2 - severe, crippling, virtually intolerable. Hellish pain and suffering. No sleep. For 12 hours..
36 2021-04-23 flushing Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild
36 2021-04-23 pain in extremity Arm very sore. Then extremely tired and all muscles achey.
36 2021-04-24 weakness, numbness, pain in extremity, tingling, tremor, feeling hot Tingling all over his body; body tingles; May have lost weight; Wheezing sound whenever he breathes;... Read more
Tingling all over his body; body tingles; May have lost weight; Wheezing sound whenever he breathes; Feeling numb; Feeling weak; no energy; Hands are shaking; Electrolytes were out of whack; electrolytes were too low; Phosphorus level was too low; Throwing up; vomiting; Vertigo; head was spinning; looked like the building was going up and down; vision was spinning; Fell three times; Face pale yellowish; Feel like going to pass out; Nausea; Felt there is pinching on left side of his chest; Heavy sweating (sweating all over his body); Head felt heavier; head was heavy in the front side of his head, not in the back; Feeling hot; 99.9 degrees body temperature; pre fever; Head felt a lttle dizzy; no control to his body like he was going to faint; Arm soreness; sore arm; Headache; it is only a little bit of pain; frontal headache; head is hurting; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was unclear and reported as either ER8727 or ED8727), via an unspecified route of administration, on 23Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history included asthma. The patient's concomitant medication included an unspecified inhaler. The patient was healthy. He has asthma, but other than that he has no health issues. He has never been hospitalized. The patient was calling to share his side effects after receiving the vaccine. He took the vaccine because it has been recommended. Most importantly, he took it for his elderly parents. He does not want to hurt them. He wants to help the community. The pharmacist told him he needed to call and report, so he googled Pfizer's phone number. On Tuesday (23Mar2021), the patient received his first dose of the COVID-19 vaccine. At first, he felt nothing. The patient's head felt a little dizzy (clarifies that it is a heavy feeling) and had a little bit of arm soreness at night (resolved about a day and a half later), but he could not complain. When the patient had the first dose, he experienced headache and sore arm the night on 23Mar2021. After the first dose, his head felt nothing like the day he went to the emergency room. He would say it was maybe 10% of the day he went to the emergency room. The next day (24Mar2021) in the morning, the patient experienced heavy sweating (sweating all over his body), feeling hot, headache, 99.9 degrees (also reported as 9.8) body temperature, and more pain on the arm. On the morning of 24Mar2021, the patient's head felt heavier. He heard people get chills, he did not get chills. He checked his temperature and it was 99.9 degrees. The patient considers that a pre fever, anything over 100 degrees is a fever to him. Sweating all over his body has gotten better. But it comes back from time to time, along with tingling all over his body (unspecified date). His body tingles, he sweats a little bit and then it goes away. His body tingling and sweating go back to back. Time passed by two days and nothing. On the sixth day (29Mar2021), the patient's mother had a doctor's appointment. After the patient got home from taking his mother to the doctor, he started sweating all over his body (started sweating again). His head was heavy (head is a bit heavy again), but not painful. It is heavy in the front side of his head, not in the back. It (head) is only a little bit of pain. He feels like his brain is going to come out of the front of his head. He started throwing up as soon as he got home. He got vertigo. He was running through the house, trying to make it to the bathroom and he fell three times (before he went to the emergency room). His head was spinning, and he could not open his eyes. The patient clarified that he could open up his eyes, but he did not want too. It looked like the building was going up and down. On 29Mar2021, the patient's face was pale yellowish, feel like going to pass out, time to time nausea and vomiting, vertigo, vision was spinning, tingling sensation, no control to his body like he was going to faint, vomited a total of 3 times, felt there is pinching on left side of his chest (the left side of his chest was pinching in the emergency room), and frontal headache. He felt like everything around him was spinning. The patient took meclizine for vertigo and medication for vomiting. The patient's father has vertigo, so his father gave him some meclizine for his vertigo. The patient also took ondansetron (ZOFRAN). The patient's family called the hotline and took him to the emergency room (ER). He has not fell again. He vomited three times, and then another in the ambulance, for a total of four times. When he got to the hospital, they started treating him. When he went to the emergency room, he did not open his eyes, and was talking with his eyes closed. All of his symptoms happened at the same time, when he came home from his mother's doctor appointment. The doctor at the emergency room told him that his electrolytes were out of whack, and that his phosphorus level was too low. They gave him some sodium sulfate right away. The doctor recommended that he stay overnight. The patient did not want to stay overnight because his parents are elderly, and he takes care of them. The doctor told him since he was not willing to stay, to go home and drink a lot of water. Per laboratory works done on 29Mar2021, the patient's phosphorous and electrolytes were too low, so they gave him saline and sodium phosphate for management. Also, the patient had abdominal and heart X-ray and computerized tomography (CT) scan done and everything came normal. Also, both X-rays came back clear. The patient had no diarrhea. Heaviness of head started feeling better after his emergency room visit on 29Mar2021. Around 02Apr2021 or 03Apr2021 is whenever it started feeling better. It comes back, and he gets scared. On 30Mar2021, the patient was almost improving and was advised to drink lots of fluids. Every now and then patient was feeling weak and head is hurting, hands are shaking on 30Mar2021. Every single day, he feels dizzy, weak and tingles all over his body. When the patient went to the emergency room, the doctor could not tell him what caused his symptoms. The doctor told him that it could possibly be because of the vaccine. He has never felt like this in his life. He has never fell in his life. He felt hopeless and was crying. He was worried about his elderly parents, and who would take care of them. The patient's second dose of the COVID-19 vaccine is due 13Apr2021. He is debating on whether to take it or not. He cannot afford to take it if it is going to make him feel worse. He has read that the second dose of the COVID-19 vaccine makes people feel worse. He is scared. He is asking if he should get the second dose of the COVID-19 vaccine. Within one week (unspecified date), he may have lost weight. The patient has to use his inhaler more now as he has a wheezing sound whenever he breathes. He has been using his inhaler more often, whenever he starts wheezing. He always feels like his whole body is tingling. He has no energy. He has only visited this doctor once. His long-term primary care physician is not practicing anymore, he thinks that he may have lost his license. It is hard for him to get an appointment with his primary care doctor since the pandemic. The patient is going to try to see his doctor through tele health. The emergency room doctor recommended that he follow up with a neurologist. The patient was advised to go to a neurologist. The patient reported these symptoms as side effects and asked how long the symptoms last. At the time of reporting, the patient currently still has that nausea and vomiting feeling, but it is better; and he feels heavy (pertaining to vertigo). If he starts to get vertigo again, he knows he will throw up. He can feel whenever the vertigo is coming, he begins to feel like the floor is moving. He can be standing still quietly, and the floor will start moving. The pharmacist told him to call Pfizer and share what happened to him. Since he took the first dose of the Pfizer COVID-19 vaccine, he spoke to the pharmacist. He was thinking of taking another company's vaccine of one shot. But they did not offer it in his area. The patient read that the first dose of the Pfizer COVID-19 vaccine gives him about 50-60% immunity. The patient was asking if he can take the other company's vaccine. The patient should have taken the other company's vaccine because it would have been one shot and done. He is nervous about taking the second dose of the Pfizer COVID-19 vaccine. He wishes he would have taken the other company's one shot because then he would not have to worry about having symptoms again. The patient's father received his second vaccine today. He asked the pharmacist there the same questions. He is still confused about if he is going to take the second dose of the COVID-19 vaccine. He cannot explain his symptoms. He can handle pain, but he cannot handle, vertigo, throwing up, and feeling numb (as reported; unspecified date). He feels like he had symptoms that people 90 and older should have. He kept falling. The patient further asked if he could take another company's COVID-19 vaccine as his second dose. Also, if it was okay if he was scheduled to get the second dose 4 weeks after the first dose. Lastly, if the company thinks that he is eligible for the second dose of the Pfizer COVID-19 vaccine despite these symptoms. The patient recovered from "Arm soreness; sore arm" on 25Mar2021; and from "Fell three times" on 29Mar2021. The patient was recovering from "Heavy sweating (sweating all over his body)", "Head felt heavier; head was heavy in the front side of his head, not in the back", "Throwing up; vomiting", and "Nausea". The outcome of the remaining events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
36 2021-04-24 feeling hot Injection site pain; Fatigue; Headache; Muscle pain; Chills; Low grade fever; Joint pain; Mild swell... Read more
Injection site pain; Fatigue; Headache; Muscle pain; Chills; Low grade fever; Joint pain; Mild swelling at the injection site; Nausea; Feeling warmness; This is a spontaneous report from a contactable consumer. A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included middle ear infection. Concomitant medication included ciprofloxacin taken for Middle ear infection. It was reported that patient got the first shot about 2 weeks ago and is still having side effects. He stated he knows it should only last a day or two and he asked what he should. When probed for symptoms experienced, consumer stated on an unspecified date he had injection site pain, fatigue, headache, muscle pain, chills, joint pain, low grade fever, mild swelling at the injection site, nausea, feeling warmness. Patient also stated, For the first couple days he took Acetaminophen they said not to take anything but Acetaminophen and since then he had been taking Ibuprofen. Outcome of the events was unknown.
36 2021-04-24 numbness Headache /body ache /pain in the ribs and numbness in back. Took one dose of Tylenol on 24th, was fe... Read more
Headache /body ache /pain in the ribs and numbness in back. Took one dose of Tylenol on 24th, was feeling better. Except for pain in the ribs everything is fine.
36 2021-04-24 limb paralysis, numbness Leg paralysis 12 hours after.; Slower cognitive functions for 5 days.; Leg numbing for 5 days.; Brai... Read more
Leg paralysis 12 hours after.; Slower cognitive functions for 5 days.; Leg numbing for 5 days.; Brain fog and fatigue for 5 days; Brain fog and fatigue for 5 days.; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6204), via an unspecified route of administration, at the age of 36 years, administered on the left arm on 05Apr2021 12:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. On 05Apr2021 23:00, the patient experienced leg paralysis 12 hours after, leg numbing for 5 days, brain fog and fatigue for 5 days and slower cognitive functions for 5 days. No treatment was received for the events. The outcome of the events was not recovered.
36 2021-04-24 pain in extremity, tingling, muscle spasms slightly faint; Instantly was dizzy; Instantly had tingling in my hands and feet; Turned into crampi... Read more
slightly faint; Instantly was dizzy; Instantly had tingling in my hands and feet; Turned into cramping in forearms, shins, and calves; mild arm pain; mild headache; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 17Mar2021 15:00 (3:00 PM) (Batch/Lot Number: eng206) as SINGLE DOSE for covid-19 immunisation. There was no medical history included. There was no covid prior vaccination, not covid tested post vaccination. The patient had no known allergies. No other vaccine in four weeks and no other medications in two weeks. The patient's concomitant medications were not reported. The patient reported that: "Instantly was dizzy and slightly faint upon injection. Instantly had tingling in my hands and feet which still has not gone away (still about 50% as bad 3 weeks later). Turned into cramping in forearms, shins, and calves. Only other symptoms were mild arm pain and mild headache, no fever, no chills." The events occurred on 17Mar2021 at 15:00 (03:00 PM). The outcome of the events was recovering. The events resulted in Doctor or other healthcare professional office/clinic visit. The treatment was unknown.
36 2021-04-25 difficulty speaking Swelling of throat, face, hoarseness hard to swallow. Headaches and light headed for weeks after.
36 2021-04-25 numbness, pain in extremity, tenderness One hour after the vaccine shot in my left arm shoulder, I see swollen, bulged black darkened nerves... Read more
One hour after the vaccine shot in my left arm shoulder, I see swollen, bulged black darkened nerves/veins in my left hand fingers/knucksles and palm region with moderate sharp pain. I see numbness on the same left hand side fingers. I see similar symptoms on my right foot with swollen and enlarged nerves with dark color. The foot area has moderate sharp pain. 32 hours after, I experienced sharp pain on back of my left leg thigh area. Bit sensitive to touch and feel the pain. Not sure these are symptoms of vericose veins or thrombosis kind.
36 2021-04-25 limb paralysis Patient stated that he experienced leg paralysis 12 hours after vaccine administration. He did not c... Read more
Patient stated that he experienced leg paralysis 12 hours after vaccine administration. He did not consult a physician.
36 2021-04-26 electric shock sensation, tingling Neuropathy. At it's worst - it felt like my body was getting shocked. Today, my feet, shins and han... Read more
Neuropathy. At it's worst - it felt like my body was getting shocked. Today, my feet, shins and hands have tingling. I was diagnosed with Small Fiber Neuropathy today.
36 2021-04-26 muscle twitching, tremor, weakness Left arm has been twitching and weak since second shot. Continues to shake and ache. Has caused neck... Read more
Left arm has been twitching and weak since second shot. Continues to shake and ache. Has caused neck pain and weakness in fingers and strength.
36 2021-04-27 feeling hot I had muscle soreness, severe headache, chills, a fever that came and went for 12+ hours. I would g... Read more
I had muscle soreness, severe headache, chills, a fever that came and went for 12+ hours. I would go from normal temperature of around 98 to 101 or so and back within a matter of 20 minutes. Additionally, random parts of my body would get very hot at times. About 2 hours after the side effects started, I became nauseous and threw up. I was unable to eat for nearly 24 hours. It seems that the fever and most side effects subsided through the 2nd night after vaccination.
36 2021-04-28 nerve pain, facial pain, bell's palsy, weakness The day after receiving the vaccine, I noticed Bells Palsy in the left side of the face along with... Read more
The day after receiving the vaccine, I noticed Bells Palsy in the left side of the face along with extreme pain on the side of the face. I went to the ER and was treated for Bells Palsy and ear infection. The next few days resulted in extreme dizziness, nausea, headaches and nerve pain. I was extremely weak and could not move due to the pain and vertigo like symptoms.
36 2021-04-29 cold sweat patient experienced dizziness, broke out in a cold sweat HR dropped to 31, o2 sat dropped to 92 and ... Read more
patient experienced dizziness, broke out in a cold sweat HR dropped to 31, o2 sat dropped to 92 and patient became pale. At this time the patient was laid back in seat and given water to drink cold wash cloth. I continued to talk with him and reassure him while monitoring his vitals to make sure they were coming up. After a couple of minutes the patient was feeling better and HR was 72 and o2 sat was 99 we continued to monitor another 30 minutes.
36 2021-04-30 pain in extremity developed headache; chills; 102°F fever; vomiting; left arm pain; This is a spontaneous report from... Read more
developed headache; chills; 102°F fever; vomiting; left arm pain; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 at 11:00 (at the age of 36 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Apr2021 the patient experienced headache, chills, 102°F fever, vomiting, and left arm pain. The patient received treatment for the events with ibuprofen. The patient underwent lab tests and procedures which included body temperature 102°F on 17Apr2021. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained
36 2021-05-02 feeling hot, feeling cold, weakness I went to bed around 10pm feeling very cold an shivering. I was able to fall asleep, but then I woke... Read more
I went to bed around 10pm feeling very cold an shivering. I was able to fall asleep, but then I woke up at 2am feeling very thirsty and experiencing intense nausea. I got out of bed to get some water. When I exited the room the nausea intensified so I knelt on the floor to wait until it passed. It didn't really pass so I stood up to try and get back to the bed. After a few steps I blacked out and fell to the floor. I was only unconscious for a few seconds, as confirmed by my wife who heard me fall. When I came to, I was lying face down and still experiencing intense nausea. I was also very hot and sweating, and very thirsty. I laid with my eyes closed an breathing very heavily to suppress the urge to vomit for a minute or two. When the urge to vomit began to subside I took a few sips of water while still lying on the ground. After another minute or two I was able to get up and get back into bed. The extreme nausea subsided after a few more minutes and I was able to drink more water. I went back to sleep after that. I woke up in the morning around 7am. I felt a little "off" for most of the day: slightly weak, a mild headache, with some difficulty focusing. But since then I have felt normal. I didn't seek medical attention or take any medication. I have experienced Vasovagel Syncope as a child so I expect that I am more susceptible to fainting like in this case.
36 2021-05-03 tingling 4 days after the first shot I was feeling very very dizzy. My ears felt full enough that I thought... Read more
4 days after the first shot I was feeling very very dizzy. My ears felt full enough that I thought maybe they were just full of wax. I bought an over the counter ear cleaning kit. That didn't relieve any symptoms. I never get headaches, but a couple days later the front top of my head was throbbing. The area just above my forehead. It was not sinus pressure, my face didn't feel any pressure or pain. My throat also felt like I was being slightly choked. Not my airway, but just my jugulars. It began in the evenings. It would feel like I had been hanging upside down for a while. My head felt full of blood, like it was going to pop, like my eyes were bugging out. By a week to 10 days later, my upper arms felt weak, my toes were tingling, and my heart would flutter for just a few seconds occasionally. I was still dizzy, still felt like I was choking, except I was feeling this way all the time now. The symptoms only seemed to be staying the same or getting worse. I have NEVER gone to the doctor on my own in my life to get something checked, but this had me disconcerted enough to check in and see if I should get my second shot at all. My appointment was to see my doctor was the morning of the same day I was scheduled to get my second Pfizer shot. My doctor had not heard of these symptoms being associated with the Pfizer shot and chalked my symptoms up to stress. I am not a stressful person and very much err on the side of "waiting to see what happens" if I feel sick. I never feel sick. But I accepted the explanation and took the second shot that day anyway. It should be noted that the second shot made my left armpit swell up quite a bit. I did feel dizzy again, but not nearly as much. The other symptoms seemed to not be as bad either.
36 2021-05-03 unresponsive to stimuli Patient was sitting in the waiting area after receiving first dose of Pfizer vaccine and called stor... Read more
Patient was sitting in the waiting area after receiving first dose of Pfizer vaccine and called store team member over and said that he felt dizzy. Upon assessing the patient he could not respond to questions and his eyes were glazed over. For a couple of minutes the patient was completely zoned out and could not respond. EMS was called to further evaluate the patient. After a few minutes the patient came back to and was able to respond to questions.
36 2021-05-04 burning sensation, muscle spasms INITIALLY presented to ER 5/2 with generalized fatigues,body aches,and subjective fevers after recei... Read more
INITIALLY presented to ER 5/2 with generalized fatigues,body aches,and subjective fevers after receiving his 2nd dose of Pfizer Vaccine against CoVID-19 on 4/28/21. Patient reports dizzy spells over the past few days with shortness of breath and then last evening developed a diffuse rash over his chest and extremities associated with itching and burning sensation on 5/1 evening. He denies any nausea,vomiting,abdominal pain,diarrhea.No chest pain or cough.Denies headaches.Denies h/o of prior allergic reaction/concerns to the first dose of the vaccine or any other vaccine.Denies any new exposure other than as stated the 2nd dose of the covid vaccine. Treated with IV steroids, IV Pepcid, and IV Benadryl with improvement. Upon discharge, directed to continue Prednsione 40mg daily for three more days for a total of five days of steroids, and follow-up with PCP. SUBSEQUENTLY, returned to ER acute onset of decreased visual acuity, diffuse arthralgias, joint pain, myalgias, lightheadedness, palpitations, vertigo, muscle spasms, and difficulty moving both upper extremities. This was accompanied by sharp, 10 out of 10, nonradiating, diffuse anterior chest pressure. Nothing made this better or worse. The patient was driving at that time, and was unable to control his arms, which resulted in his vehicle leaving the roadway. He was able to bring the vehicle to a stop before crashing. Since then, his symptoms have gradually improved, although they have not completely resolved. The characteristics are identical to the events that led to his previous admission.
36 2021-05-04 feeling hot First few hours felt warm... started to feel dizzy and sore... by evening had a fever and aching... ... Read more
First few hours felt warm... started to feel dizzy and sore... by evening had a fever and aching... the next day could barely move... high temperature... very sore all over body. Symptoms had subsided by the third day.
36 2021-05-04 tremor Chills, fever, body aches, tremors, sleeplessness
36 2021-05-05 pain in extremity Sore arm shortly after shot that continued for three days. Aches and chills with no fever that last... Read more
Sore arm shortly after shot that continued for three days. Aches and chills with no fever that lasted for 24 hours. Also, after I got better I wanted to run mask-free through fields of wildflowers, but that was probably me not the vaccine.
36 2021-05-06 weakness, migraine Dizziness, constantly tired, nausea, room spins when I stand up, I have fainted twice, constant mig... Read more
Dizziness, constantly tired, nausea, room spins when I stand up, I have fainted twice, constant migraine (I have had it for 14 days now) , often very weak,
36 2021-05-06 cold sweat Adverse Event: Syncopal Episode s/p Vaccine Administration Details: Pt presenting into exam room 1 ... Read more
Adverse Event: Syncopal Episode s/p Vaccine Administration Details: Pt presenting into exam room 1 for Pfizer COVID vaccine dose 1 around 6:20pm. Vaccine was administered into LT deltoid and pt stated that he is known to pass out after vaccines. I advised pt to stay in clinic for 15 mins or more if needed and pt agreed, and I also gave him 2 small bottles of water and highly advised him to drink them while he waited the 15 mins. I asked pt if he wanted to sit in our exam room but declined and stated that he would sit outside in our waiting area. After 5 mins (around 6:25pm), customer came and told us that someone was laying on the floor. Patient was found on other side of wall divider on the LT hand side of our waiting area laying on the LT side of his face and on his stomach. Pt aroused immediately to tactile stimulation and me calling his name. He was oriented X4 and stated that he was okay but wanted to lay on the cool floor for a moment. Pt was cool and clammy to touch and skin color pale pink. No hematomas or lacerations noted to face or head. No seizure activity noted. Stayed on floor for approx 3-4 mins and myself and another person stayed with him. There were 2 other patients present in the waiting room at the time, and the pharmD, also responded to make sure that we did not need any more help. After 3-4 mins of pt resting on floor, he agreed to get up and go into exam room 2 to lay on exam table. Patient said that he knew he was going to pass out because he heard ringing in his ears so he sat on the floor. He said the next thing he knew, I was calling his name and he was laying on the floor. Pt was escorted by me to room 2. AAOx4. V/S taken at that time: BP 120/80 HR 74 RR 16 O2 sats 98%. Skin warm and darker pink. Exam table put in incline position and pt resting there until 6:40p. Drank his 2 small bottles of water that was given to him and was stable upon leaving clinic. Offered to call someone to come get him but pt declined.
36 2021-05-06 flushing Vomiting, dizziness, flushing/sweating, vitals wnl. Known h/o of anxiety and vomiting with vaccines.
36 2021-05-07 weakness Around 2 weeks after receiving the first vaccine dose, I woke in the middle of the night gasping for... Read more
Around 2 weeks after receiving the first vaccine dose, I woke in the middle of the night gasping for air. My heart was racing and I was so weak that I could barely sit up. The following day I could not get out of bed. I also had an intense headache, which is unusual for me since I never get headaches. On the 3rd day I developed dizziness/vertigo. Since those events occurred, I've been dizzy 24/7 and had about 25-50% of my normal energy. I cannot drive, I cannot work, I cannot many of my normal daily activities. This has been devastating. It has been over 3 weeks now with these symptoms, and I will probably lose my job this week. I don't know where to turn. There should have been a safety net for these things.
36 2021-05-09 discomfort High Fever, Pain behind the eyes, sharp headache, chills, sleeplessness, discomfort, bloating, indig... Read more
High Fever, Pain behind the eyes, sharp headache, chills, sleeplessness, discomfort, bloating, indigestion
36 2021-05-09 muscle spasms muscle spasms on the left side of the neck and upper part of the left shoulder
36 2021-05-10 grand mal seizure Grand Mal Seizure 3 days after injection. I was brought to the ER and had tests done. I had a clear... Read more
Grand Mal Seizure 3 days after injection. I was brought to the ER and had tests done. I had a clear EEG, EKG, CAT scan, and MRI. I am now on Keppra.
36 2021-05-10 nerve injury, hypersensitivity of all senses, pain in extremity Thrombosis; Vericose veins; Swollen, bulged nerves around left hand palm and fingers/The same sympto... Read more
Thrombosis; Vericose veins; Swollen, bulged nerves around left hand palm and fingers/The same symptoms noticed on right foot; Nerves are in black darkened color and the palm fingers, knuckle areas; the palm, fingers, knuckle areas had moderate pain. The same symptoms noticed on right foot.; the palm, fingers, knuckle areas had moderate pain; sensitive to touch; This is a spontaneous report from a contactable consumer(patient). The 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Apr2021 14:45 (Lot Number: EN6205) as first dose, single for covid-19 immunization. Medical history included none. He had not known allergies to food or medications, no illlness history. Concomitant medications included minerals nos, vitamins nos (CENTRUM A TO ZINC) adutls vitamin, miconazole nitrate (LOTRIMIN AF ANTIFUNGAL) topical cream. The patient experienced one hour after first dose of vaccine shot at left arm shoulder, he saw swollen, bulged nerves around left hand palm and fingers. Nerves were in black darkened color and the palm, fingers, knuckle areas had moderate pain. The same symptoms noticed on right foot. The affected areas on both palm, fingers, foot area have dark patch areas with moderate pain. After 32 hours, he saw swollen nerve back of left leg thigh area with deep pain. It was sensitive to touch. It looked like thrombosis or vericose veins not sure about it. He reached out to doctor office and they said to wait for another day to see if he can recover. whereas he still have the darkened black nerve with pain in the affected areas. Events occurred on 24Apr2021 16:00 which was resulted in doctor or other healthcare professional office/clinic visit. There was unknown if treatment received. Outcome of events was not recovered. There was no covid prior vaccination and post vaccination.
36 2021-05-10 pain in extremity He found out a few minutes ago that a person he was with yesterday has Covid 19; Arm soreness; This ... Read more
He found out a few minutes ago that a person he was with yesterday has Covid 19; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 22Apr2021 (Lot Number: EW0170) as a single dose for covid-19 immunisation. The patient received the first dose on 01Apr2021 (Lot number: ER8727) for Covid-19 immunisation in the left arm. The patient's medical history and concomitant medications were not reported. The patient inquired if he should get tested tomorrow (23Apr2021) and what do he do if he is positive. He also inquired if he needs to do anything different and If he had Covid, would he need to get a third vaccine. The patient reported that he received the second dose of the Pfizer Covid 19 vaccine today (22Apr2021). He found out a few minutes ago that a person he was with yesterday has Covid 19. He heard you shouldn't get the vaccine if you've been exposed. He inquired what was recommended. He is asymptomatic for Covid 19 at this time and only has some arm soreness from his second vaccine. The outcome of the events was unknown.
36 2021-05-11 numbness feeling numbness on the side of my right thumb
36 2021-05-12 feeling of body temperature change, pain in extremity Chills, fever, fatigue. Arm is swollen and sore. Legs are sore. Have spent the last two days tryi... Read more
Chills, fever, fatigue. Arm is swollen and sore. Legs are sore. Have spent the last two days trying to sleep. Cannot decide if I am hot or cold.
36 2021-05-12 migraine 1) Heart Palpitations. I developed episodes of prolonged heart palpitations 12 days after my second... Read more
1) Heart Palpitations. I developed episodes of prolonged heart palpitations 12 days after my second Pfizer shot. Sometimes I have an irregular heartbeat (80 BPM); sometimes I have a racing sinus heartbeat (120-130 BPM). My normal resting heart rate is slightly below 60 BPM. The palpitation episodes occur 2-3 times/week, and last from 2 minutes to 2 hours. I contracted Covid-19 in March 2020 and had mild cold-like symptoms that lingered for around 6 weeks. In June 2020, I began to experience the palpitation symptoms I am feeling now. My symptoms subsided and disappeared from December through April of this year. I am undergoing tests to determine what is causing my palpitations. EKG and Echocardiogram came back normal. I wear an Apple Watch that has confirmed Possible AFib / High Heart Rate during my episodes of Palpitations, using the ECG feature. 2) Migraine Headaches. 3 days after the second Pfizer shot, I began experiencing daily headaches on the left side of my head. The headaches typically begin around the mastoid area, but alternate in other areas including above my left eye, left temple, left sinus, and back of head. The headaches come and go, and are varying severity, but I've had some form of headache on same side of head every day since April 8, three days after my second shot.
36 2021-05-12 pain in extremity Unilateral rash on left thigh. Pain due to touch.
36 2021-05-13 weakness Cellulitis; immune system being weakened; fevers which came and went; chills; sweats; nausea; loss o... Read more
Cellulitis; immune system being weakened; fevers which came and went; chills; sweats; nausea; loss of appetite; light headedness; lack of energy; This is a spontaneous report from a contactable consumer (the patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0151) via an unspecified route of administration in left arm on 06Apr2021 12:30 at age of 36-year-old at single dose for COVID-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205) via an unspecified route of administration in left arm from 16Mar2021 12:30 at age of 36-year-old for COVID-19 immunization. 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. 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 was very sick for 4 days: fevers which came and went, chills, sweats, nausea, loss of appetite, light headedness, lack of energy. As a result of his immune system being weakened, he wound up with Cellulitis which he was still fighting over 3 weeks after the shot. As the patient was normally a healthy male, it was strange that he would wind up with a bacterial infection. The patient also stated that after the second dose he experienced cellulitis in his left leg to thigh area. He went to emergency room for scan and to rule out clot. He thought he was immunocompromised and that was why he got the cellulitis in the leg. Caller wanted to get the compensation information to help with the bills. The events onset date was 06Apr2021 17:00. 2 rounds of antibiotics was received for the events. The events result 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 ultrasound with unknown result. The outcome of the events was recovering.
36 2021-05-13 tenderness, weakness Very tender headache and over-all achy body like the flu and complete body weekness.
36 2021-05-14 bell's palsy Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male... Read more
Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, in arm left, on 08Apr2021 16:00 (at the age of 36-year-old), at single dose, for COVID-19 immunization. Medical history included cholesterol, anxiety, depression, and Barrera esophagus. No known allergies. Concomitant medications included unspecified medication (patient received other medications within 2 weeks of vaccination). The patient previously received 1st dose of BNT162B2 for Covid-19 immunization, in left arm. The patient experienced Bell's palsy a month after 2nd shot on 03May2021, and received Steroids and antivirus medicine as treatment. The event caused Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have Covid prior vaccination. On 04May2021, patient had negative Covid test post vaccination with Nasal swab. The outcome of the event was recovering. Information on the lot/batch number has been requested.
36 2021-05-14 brain damage, cold sweat This is a spontaneous report received from a contactable physician (patient). A 36-year-old male pat... Read more
This is a spontaneous report received from a contactable physician (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number EW0169), via unspecified route of administration in left arm on 29Apr2021 05:00 PM (at the age of 36-year-old) as 2nd dose, single for COVID-19 immunisation. The patient had no medical history. Prior to vaccination the patient was not diagnosed with COVID-19. No concomitant medications were reported. The patient did not receive any other medications 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 BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number EW0150), via unspecified route of administration in left arm on 05Apr2021 04:00 PM (at the age of 36-year-old) as 1st dose, single for COVID-19 immunisation. On 30Apr2021 09:00 the patient experienced encephalopathy, vertigo, dizziness, fever, chills, nausea, myalgia, fatigue, cold sweats, headache, neck pain, injection site pain. The reporter stated that he was a doctor, he treated himself symptomatically. Patient had not been tested for COVID-19 since the vaccination. The outcome of the events was resolved with sequel.; Sender's Comments: The etiology for the reported event could be multifactorial however.Based on a temporal association a causal relationship between the reported event and suspect drug is assessed as possible. 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.
36 2021-05-14 muscle spasms Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, S... Read more
Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; This is a spontaneous report from contactable consumer (patient). A 36-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown), via unknown route of administration on the left arm on 02Feb2021 at 11:30 AM, as a 1st single dose for covid-19 immunization. Medical history of the patient was none. Patient did not have any known allergies. Patient did not receive any other medications in two weeks after vaccination. Patient did not receive any vaccine within 4 weeks prior to the first dose of vaccine. Prior to vaccination, patient did not diagnose with Covid-19. On 10Feb2021 at 01:00 AM after receiving first dose of vaccine, patient experienced extreme pressure in brain, screaming tinnitus, muscle cramps and aches, which was resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment received for the events included medicine (unspecified). Since the vaccination, patient has not been tested for Covid-19. Outcome of the events were not recovered. Information on the lot/batch number has been requested.
36 2021-05-14 pain in extremity, limb paralysis Paralysis of left arm.; Extreme pain in left shoulder and arm for 6 weeks and counting.; Extreme pai... Read more
Paralysis of left arm.; Extreme pain in left shoulder and arm for 6 weeks and counting.; Extreme pain in left shoulder and arm for 6 weeks and counting.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left arm on 23Mar2021 at 09:00 (Lot Number: EP6955) at the age of 36-year-old as SINGLE DOSE for COVID-19 immunization. The patient did not have any relevant medical history and concurrent conditions. The patient did not have any concomitant medications. 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 an unspecified date, the patient experienced paralysis of left arm, extreme pain in left shoulder and arm for 6 weeks and counting. The patient visited to the emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit due to the reported events. Therapeutic measure was taken for the reported events included unspecified medication and physical therapy. The outcome was reported as not recovered for the reported events.
36 2021-05-14 seizure Per his mom patient had a seizure around 6 pm on 05/11 and his girlfriend fainted/collapsed. 911 was... Read more
Per his mom patient had a seizure around 6 pm on 05/11 and his girlfriend fainted/collapsed. 911 was called. Both went to emergency room. Patient was put on IV and his girlfriend was rushed to the hospital. This is all the information we have at the pharmacy. We have no been contacted again (though we have asked).
36 2021-05-16 tingling Reported right hand tingling. Stated he was fine wanted to leave after 15 minutes. No signs or sym... Read more
Reported right hand tingling. Stated he was fine wanted to leave after 15 minutes. No signs or symptomes of distress.
36 2021-05-17 tingling I got Pfizer covid vaccine (first shot) on April 9th and have been suffering from prickling (pins an... Read more
I got Pfizer covid vaccine (first shot) on April 9th and have been suffering from prickling (pins and needle) on my body. This prickling happened randomly anywhere in my body (feet, arms, chest, all over the place of the body) and happened frequently everyday since I the second day I received the vaccine. It is six week now since I got the vaccine, but pins and needle feeling still haul over me. I search online and found there are hundreds of people complaining about the same side effect I had. Some even say that this pins and needle feeling persist for months. I am not sure whether this pins and needle feeling eventually goes away. and I hope someone looks into this side effect and give us some guidance since there is no official document talks about this side effect.
36 2021-05-18 weakness, flushing, tremor Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Severe... Read more
Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
36 2021-05-20 feeling cold, feeling hot, tingling Lightheaded, hot, cold, headache tingling reported about 2 minutes after injection. Cold pack and co... Read more
Lightheaded, hot, cold, headache tingling reported about 2 minutes after injection. Cold pack and cold water given. V/s 96.4, 20, 110/60. No wheezing no shortness of breath and no chest pain and no syncopal episode. 911 called and client decline to go. About 10 minutes later stated felt better 98-100% left Aox4 and ambulating well. All protocols followed
36 2021-05-20 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient received 1st pfizer vaccine and after 10 min he felt light headed and passed out. He layed on the ground and was responsive and was able to communicate. He did not have any injuries after passing out. He remained laying down for about 15 min until his pressure came back up and he said he felt ok. He asked for a glucose tablet which we administered. He said he has had this type of reaction before to receiving vaccines but did not indicate that ahead of time. He did not want ambulance.
36 2021-05-20 flushing Systemic: Flushed / Sweating-Mild.
36 2021-05-21 cold sweat, weakness Received injection at approx 10:45am, became pale, clammy skin, and c/o weakness. Blood pressure low... Read more
Received injection at approx 10:45am, became pale, clammy skin, and c/o weakness. Blood pressure low, patient stated he had not eaten today. EMS here at 11:08, blood pressure normotensive. Patient states he feels better, significant other called and arrived. Patient reports he has had vasovagal/fainting episodes with vaccines/injections in the past. Patient stable, A&0x4, in good spirits, EMS deemed patient stable and able to return home with significant other.
36 2021-05-22 numbness Numbness and tingling in the arms and hands. Pain and pressure near the heart and lungs. No treat... Read more
Numbness and tingling in the arms and hands. Pain and pressure near the heart and lungs. No treatment has been given. Symptoms still continue as of 5/23/21.
36 2021-05-22 unresponsive to stimuli Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Called 911 and EMT completed an evaluation and released patient to go home
36 2021-05-23 seizure Diaphoresis started same day following COVID vaccine 05-15-2021. On 05-16-2021, patient lost conscio... Read more
Diaphoresis started same day following COVID vaccine 05-15-2021. On 05-16-2021, patient lost consciousness and had a seizure. Taken to ED for evaluation.
36 2021-05-24 pain in extremity This is a spontaneous report from a non-contactable consumer (patient himself). A 36-year-old male p... Read more
This is a spontaneous report from a non-contactable consumer (patient himself). A 36-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in left arm on 27Jan2021 at 08:30 as single dose for COVID-19 immunisation at Workplace clinic. The patient medical history was not reported. No known allergies were reported. Concomitant medications in two weeks were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 27Jan2021, the patient experienced sore arm 8 to 36 hours post injection, chills and aches 24-36 hours post injection. No treatment was received for the events. The outcome for all events was recovered in 2021. No follow-up attempts are possible. No further information is expected.
36 2021-05-25 feeling hot, tingling, numbness Patient stated he took the vaccine on Thursday 5/13, he felt fatigued the same night but on Saturday... Read more
Patient stated he took the vaccine on Thursday 5/13, he felt fatigued the same night but on Saturday started to feel numbness in legs and forearms but comes and goes. He also stated his face felt hot and tingly but still had sensation in it. He also felt a slight headache but that subsided on 5/21/21 when patient went ER. No c/o fever, body aches, sob, cough. Patient took ibuprofen to help with the headache and it helped. He stated what he felt started with tingling and then joint pain and numbness but no exact time how long it lasts, he stated sometimes it lasts a few minutes and sometimes as long as an hour but it comes and goes, he states he feels the sensation almost every day. He states he switches between the ibuprofen and the Tylenol and he does feel a little relief from taking either or.
36 2021-05-27 bell's palsy I have developed severe Bells Palsy
36 2021-05-28 burning sensation, tingling, numbness Numbness from the knees down, numbness from the elbows down; burning sensation in his joints; burnin... Read more
Numbness from the knees down, numbness from the elbows down; burning sensation in his joints; burning and tingling sensation in his face; burning and tingling sensation in his face; exhaustion; really bad headache; This is a spontaneous report from a contactable 36-year-old male consumer reported for himself. A 36-years-old male patient received bnt162b2 (BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown, via unspecified route, on 13May2021 (at 36-years age) as 1 st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. In May2021 the patient had experienced numbness from the knees down, numbness from the elbows down, burning sensation in his joints, burning and tingling sensation in his face. All these effects come and goes. He also experienced exhaustion and a really bad headache 1 night. He had already gone to the ER twice. The patient underwent lab tests and procedures which included several blood test, CAT Scan (computerized tomogram), EKG(Electrocardiogram) which all came back normal, and he was perfectly fine. He had consulted with his neurologist and orthopedic doctors and both had no findings for him. The outcome of the events was unknown. Information on the lot/batch number has been requested.
36 2021-05-28 migraine headaches; migraine; My endurance has also been greatly impacted and I have not been be able to exer... Read more
headaches; migraine; My endurance has also been greatly impacted and I have not been be able to exert myself for any extended period of time. Ten minutes of light activity is about all I manage.; My endurance has also been greatly impacted and I have not been be able to exert myself for any extended period of time. Ten minutes of light activity is about all I manage.; This is spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm, at age 36 years, on 08Apr2021 13:30 (Batch/Lot Number: ER8729) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had not had other vaccines in four weeks prior to the COVID vaccine. Patient had no other medications in two weeks. The patient historically took the first dose of BNT162B2 (Batch/lot number: ER2613) on 17Mar2021 at 02:00 PM on the left arm COVID-19 immunization. Adverse event start date and time was 09Apr2021 at 06:00AM. Patient reported having continuing and persistent headaches since his vaccine. After his second vaccine, he experienced his first ever migraine and it was very intense. Maximum intensity lasted for about 6-8 hours. His endurance has also been greatly impacted and has not been be able to exert himself for any extended period of time. Ten minutes of light activity is about all that he could manage. At the time of report, patient was still experiencing headaches more frequently than ever before. No treatment was received for the events. The adverse events resulted in disability or permanent damage. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Information on Lot/Batch number has been obtained.
36 2021-06-01 slurring sharp chest pain randomly; dizziness; slurred speech; severe joint pains; muscle pains; fast heart r... Read more
sharp chest pain randomly; dizziness; slurred speech; severe joint pains; muscle pains; fast heart rate over 100 beats per min; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01May2021 15:00 (at the age of 36-years-old) (Batch/Lot Number: EW0172; Expiration Date: Aug2021) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. 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 no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since 05May2021 13.00, the patient started experiencing sharp chest pain randomly, then had dizziness and slurred speech. Went into ER to check out and looked all fine per CT scans and MRI. Few days later, he started feeling severe joint pains and muscle pains. Last few days, he had fast heart rate over 100 beats per min (before his resting heart rate was 50-60). AE resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. No treatment received for AE. Reporter assessed the event as non serious. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included RT-PCR, covid test post vaccination (nasal swab): Negative on 11May2021. Outcome of the events was unknown.
36 2021-06-01 pain in extremity EXTREME ADVERSE SEVERE REACTION TO THE SECOND VACCINE. I HAVE BEEN SICK WITH FLU LIKE SYMPTOMS FOR O... Read more
EXTREME ADVERSE SEVERE REACTION TO THE SECOND VACCINE. I HAVE BEEN SICK WITH FLU LIKE SYMPTOMS FOR OVER A MONTH. I WAS IN BED FOR A WEEK A DAY AFTER THE SHOT. I HAVE NEVER FELT SO SICK IN MY LIFE. I THOUGHT I WAS GOING TO DIE. I AM STILL SICK. MY RIGHT ARM THAT GOT THE SHOT STILL HURTS I ALSO AM UNABLE TO SLEEP ON MY RIGHT SIDE FROM THIS. I CAN NOT WORK I AM TOO SICK TO FUNCTION. PLEASE HELP.
36 2021-06-01 tenderness, pain in extremity 5/9/21 - Pain on right toe, noticeable when walking and tender to touch. Gait affected. 5/11/21 - Pa... Read more
5/9/21 - Pain on right toe, noticeable when walking and tender to touch. Gait affected. 5/11/21 - Pain worsened to the point of being unable to sleep. Right toe pain sensitive to slightest touch and flex, impairing normal walking. 5/11 - 5/19 - Pain and swelling to right foot persisting, necessitating MD visit. Unable to bear weight to foot. 5/20 - Improvement of symptoms
36 2021-06-02 slurring -random chest pain - 5 days after first dose -dizziness, slurred speech and chest pain - 10 days fro... Read more
-random chest pain - 5 days after first dose -dizziness, slurred speech and chest pain - 10 days from first dose - 5/11 -joint pains, movement problems - 5/14 - fast heart rate - 110-120bpm without activity - 5/17
36 2021-06-06 feeling hot Sudden onset of warmth, diaphoresis, darkening of vision, and inability to hear. Reported while sitt... Read more
Sudden onset of warmth, diaphoresis, darkening of vision, and inability to hear. Reported while sitting and remaining in his chair. No fall or injury. Return of consciousness quickly on the vaccination floor. Full recovery after 27 minutes of observation. Initial BP was 71/57 sitting and alert, he was placed supine. Next BP was 98/63, and remained in the normal range thereafter. Pulse -88-103. O2 sat 97%. No orthostasis after recovery. Standing BP - 114/83. Very typical and self resolving vasovagal reaction.
36 2021-06-06 seizure pt states he had a seizure at work at approximately 6:00 p.m., 4 hour after vaccine. He states he i... Read more
pt states he had a seizure at work at approximately 6:00 p.m., 4 hour after vaccine. He states he is certain that it was from the vaccine as his seizures are under control until he received the vaccine. Pt. could not stay any longer to speak about the seizure as his ride was here.
36 2021-06-07 slurring, pain in extremity dizziness; fatigue; slurred speech; acute memory problems; constant headaches that could last 30 sec... Read more
dizziness; fatigue; slurred speech; acute memory problems; constant headaches that could last 30 seconds to 30 minutes, generally around the temple bilateral; fainting; woke up in the middle of the night screaming; woke up in the middle of the night screaming; soreness on left arm at site of injection; soreness under left arm; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 23Apr2021 at 09:00 (Lot Number: EW0172, at the age of 36-year-old) 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 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Apr2021 at 09:00 (Lot Number: EW0150, at the age of 36-year-old), as single dose for covid-19 immunization. First day after 2nd shot on 23Apr2021, soreness on left arm at site of injection and soreness under left arm. This last 2 days. Day 2 after shot on 24Apr2021 at 08:00, dizziness, fatigue, fainting, slurred speech, acute memory problems, constant headaches that could last 30 seconds to 30 minutes, generally around the temple bilateral. On 4 separate occasions on 24Apr2021, woke up in the middle of the night screaming because his head hurt so bad. Pain was easily a 9 or 10 our of 10. There was no treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no any other medications the patient received within 2 weeks of vaccination. The adverse events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had COVID-19 test on 14May2021, nasal swab and was negative. The outcome of the events "soreness on left arm at site of injection" and "soreness under left arm" was recovered on unspecified date in Apr2021, for other events was not recovered.
36 2021-06-07 pain in extremity Sore arm on the afternoon of May 11. Pain continued to get worse until the evening of May 15 when so... Read more
Sore arm on the afternoon of May 11. Pain continued to get worse until the evening of May 15 when sores/blisters started to appear.
36 2021-06-08 bell's palsy Bells Palsy
36 2021-06-08 tingling Patient reported to observation nurse dizziness and tingling sensation in his fingers and right arm.... Read more
Patient reported to observation nurse dizziness and tingling sensation in his fingers and right arm. Patient' s vitals noted at 153/102 heart rate 88, Temp 97.7, Res. 20. Patient verbalized anxiety regarding receiving the vaccine. Patient was offered water and encouraged to relax. Vitals were repeated fifteen minutes later. Blood pressure noted at 171/111, heart rate 88 Res. 22. The decision was made to contact EMS. Patient was assessed by EMS and vitals improved at 150/96, Heart rate 76, Pulse 20. Patient was provided patient teaching should condition worsen. Patient was released and was driven home by his wife.
36 2021-06-10 burning sensation, muscle spasms, tingling, trigeminal neuralgia After getting the second vaccine , I had the lip tingling and chin tingling for about 15 mins after.... Read more
After getting the second vaccine , I had the lip tingling and chin tingling for about 15 mins after. I also had jaw pains and low blood pressure which had me get me on the stretcher for about 55mins. My teeth also went numb as well. About 12 hours in I had a burning sensation in my checks and the site where I got my vaccine. First dose vaccine lot number is EN6200 I received this vaccine on February 26, 2021. With the first vaccine 20-25 after the vaccine I felt like I had a brain freeze, After one hour I had face tingling and throughout that day the face tingling got worse and my face went numb. I had right toe tingling with the first and second vaccine. The muscle spams happened three days after the vaccine and I still have muscle spams today.
36 2021-06-14 weakness Dizziness, light headed, heart pain, chest pain low energy
36 2021-06-14 weakness I started experiencing "fullness" and pressure inside my head and ears, slight dizziness, tinnitus,... Read more
I started experiencing "fullness" and pressure inside my head and ears, slight dizziness, tinnitus, and trouble focusing. This started approximately 60 hours after 2nd vaccine dose, after the normal side effects such as fever and weakness had passed. I have waited 24 hours for the symptoms to subside, but they are the same as of today.
36 2021-06-16 weakness The symptoms of this adverse event were noticeable tiredness and weakness continue beyond a week aft... Read more
The symptoms of this adverse event were noticeable tiredness and weakness continue beyond a week after the second vaccine dose. Went to primary doctor who then sent me to physical therapy. During my first visit, the physical therapist found that the was significant weakness on the left side of my body. The therapist suspects the vaccine shot temporarily enhanced a previously unknown issue enough where it became noticeable. The therapist says this 'enhancement' effect would go away in time.
36 2021-06-16 numbness, facial paralysis, bell's palsy, involuntary muscle movements Nearly three week after getting the first vaccine from Pfizer, I started to experience numbness in m... Read more
Nearly three week after getting the first vaccine from Pfizer, I started to experience numbness in my face. On Saturday night (May 8th) I expressed to me wife that I noticed that I couldn't close my mouth all the way, and my face was really numb. When I woke up Sunday morning the entire right side of my face was paralyzed. I was unable to close my right eye, flare my right nostril, open the right side of my mouth. We went directly to the hospital thinking I was having a stroke, and it was there that I was diagnosed with Bells Palsy.
36 2021-06-16 pain in extremity very tired; sore arm; This is a spontaneous report from a non-contactable other healthcare professio... Read more
very tired; sore arm; This is a spontaneous report from a non-contactable other healthcare professional. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: unknown) via unspecified route, as unknown, single dose on 22Mar2021 for COVID-19 immunization (at the age of 36-years). Medical history included chronic myeloid leukaemia, pancreatitis acute, Chronic Idiopathic urticaria, MALS released post op complications (bleeding), hepatic ischaemia, cholecystectomy, VATS decussation bil lungs, plurex bil lungs and ongoing idiopathic urticaria. The patient's concomitant medications were not reported. On unspecified date it was reported that patient experienced very tired & Sore arm. The clinical outcome for the event was unknown. Follow up needed, further information has been requested.
36 2021-06-16 tenderness, feeling hot Tenderness to left shoulder where injected; face felt warm; loss of appetite; chills; headache; flu ... Read more
Tenderness to left shoulder where injected; face felt warm; loss of appetite; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in arm left on 09Jun2021 at 17:30 (Batch/Lot Number: Ew0182) as 2nd dose, single dose for covid-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included, on an unspecified date, patient received the first dose of bnt162b2 via an unspecified route of administration, as single dose for covid-19 immunization (Dose number 1, lot_number=Ew0182, for COVID-19 immunization, Vaccine location: Left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient did not receive medication within 2 weeks of vaccination. On 09Jun2021 at 19:30, the patient experienced tenderness to left shoulder where injected, face felt warm, loss of appetite, chills, headache, and flu like symptoms. The patient did not take any treatment for the events. The outcome of the events loss of appetite and flu like symptoms on 10Jun2021 whereas other events were resolved on an unknown date. No follow-up attempts are possible. No further information is expected.
36 2021-06-17 pain in extremity Had a severe allergic reaction after a previous dose; ringing in the ear; feeling of pressure in the... Read more
Had a severe allergic reaction after a previous dose; ringing in the ear; feeling of pressure in the ear; arm hurt; joint pain; armpits hurt; muscle pain; bones hurt; super tired and fatigued; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 at 12:30 PM as single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, patient reported that got his first dose of the Pfizer COVID-19 vaccine April 13th and was due for his follow up second dose on May 4th. Stated that vaccine card information was handwritten and the NDC/EXP were not provided on there. Caller stated that got a lot of the normal things, like his arm hurt, he had joint pain, his armpits hurt, he had muscle pain, and his bones hurt a little bit and reported that 5-6 hours after getting the vaccine he had ringing in his ears and that lasted a bit but then it went away, then the next day it came back, and not had the ringing since then. Stated that had slight pressure in his ears that is still there, but the ringing only happened the first two days. The pressure feels like an ear infection, no treatment for the ear ringing or pressure, but called his primary care provider and they told him to wait a bit and also said he could come in or he could try over the counter ear ringing medications, but they recommended calling to report it to Pfizer and get their opinion on it, she doesn't see any reason he could not get the second dose. Stated that his armpit hurting and things only lasted a couple hours, didn't take anything for the other pains either. Stated arm felt like an anvil for days, was super tired and fatigued. Still muscle and joint pain lasted a couple days after or lasted a day or two, main reason he called was because of the ear ringing and pressure. The outcome of the events was unknown. Follow-up (PRD 04May2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included the information. Follow-up actions are closed. No need of further information.
36 2021-06-22 weakness Lower extremity myalgias and perceived weakness, currently hospitalized
36 2021-06-24 numbness, tingling pt states approximately 24 hours after the vaccination he noticed, numbness and tingling of his left... Read more
pt states approximately 24 hours after the vaccination he noticed, numbness and tingling of his left arm and a heaviness in his chest. symptoms have improved over the past week. He did not seek medical attention when the symptoms first started.
36 2021-06-24 pain in extremity Horrible nightmares; Sweating; Sore arm for 3 days; Feeling of unreality; Headaches; Chills; This is... Read more
Horrible nightmares; Sweating; Sore arm for 3 days; Feeling of unreality; Headaches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 36 years old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ew0171), via an unspecified route of administration in the left arm on 26Apr2021 at 16:45 (at the age of 36-years-old), as a first single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included Suboxone (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 27Apr2021 at 13:00, the patient experienced horrible nightmares, sweating, sore arm for 3 days, feeling of unreality, headaches, and chills. The clinical outcome of horrible nightmares, sweating, sore arm, feeling of unreality, headaches, and chills was recovering. No follow-up attempts are possible. No further information is expected.
36 2021-06-28 tremor Pt is a 36 y/o Caucasian Male who came for Covid-19 vaccine At 0845am_ I called him in to the room ... Read more
Pt is a 36 y/o Caucasian Male who came for Covid-19 vaccine At 0845am_ I called him in to the room and during the questions about allergies and reactions to medications: So, he expressed to me that he suffered from Anxiety and panic attacks sometimes and that he had not gotten vaccines since childhood. He also verbalized apprehension about the severe side effects of this vaccines. I talked to him for a while, reassured him that the vaccination process was painless. At around 0900am I gave him the Vaccine and Kept him sitting in my room after to closely observe him. I reviewed the possible severe and mild side effects before and after Vaccine. He verbalized understanding. At 0910_ I asked him how he was feeling, and he stated that? he didn?t feel well, that he felt weird and shaky.? I called for help and nurse came in talk to Pt for a couple minutes then I asked her to call RN. They both came in the room where Pt was sitting and after talking to him for a few minutes and trying to calm him down the RN notified the Provider NP @0915_NP came in the room to assess the Pt and told us to call 911. @0920_ nurse called 911 and gave reports of Pt condition, while we transferred Pt on to exam bed and plugged Vital-Sign machine. Pt continue to hyperventilate and check his own pulse in his Carotid area. B/P 138/85; Pulse 88; RR 22; PO2 100%. @925_ the Paramedics arrived and after giving them report they assessed Pt and tried to coach Pt to slow down his breathing pattern and offered reassurance that his vital signs and Po2 was normal @ 100 % in Room air; And they also offered to take him to the hospital, but Pt declined He stated ?I?ll be Ok? this happens before. @940 Vital Signs at this time were- B/P 120/82; PR 80; PO2 100%; RR20. @950 Paramedics prepared to leave and help Pt to sit in waiting room chair. Pt sat in waiting area for 15 more minutes until he felt better and left to his home in stable condition.
36 2021-06-29 numbness Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, ... Read more
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Injection arm is numb
36 2021-06-29 numbness I felt dizzy at 12 PM on the 17th of June 2021. Then at 1 pm I started to feel dizzy and then my hea... Read more
I felt dizzy at 12 PM on the 17th of June 2021. Then at 1 pm I started to feel dizzy and then my heart rate increased so I dialed 911. I then started to lose feeling in my left hand. Then when the ambulance picked me up, my right hand started to go numb. The doctors at emergency think its possibly anxiety and I had a panic attack. I am taking anxiety meds for the anxiety but I am still having heart palpitations.
36 2021-06-29 pain in extremity Sore Arm; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old male... Read more
Sore Arm; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER2613], via an unspecified route of administration in left arm on 22Mar2021 at 09:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient 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 since the vaccination, the patient had not been tested positive for COVID-19. On 22Mar2021 at 11:15, the patient experienced sore arm. 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 event. The clinical outcome of the event sore arm was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
36 2021-06-29 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male ... Read more
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male 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 22Mar2021 at 1500 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was not reported. On 22Mar2021 1500, the patient experienced sore arm. 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 treatment for the events. The clinical outcome for the event sore arm was resolving at the time of the report. Information about lot/batch number cannot be obtained. No further information is expected.
36 2021-06-29 tingling Tingling in both hands and arms, likely tingling in feet too.; This is a spontaneous report received... Read more
Tingling in both hands and arms, likely tingling in feet too.; This is a spontaneous report received from a contactable consumer, the patient. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6204) via an unspecified route of administration in the left arm on 15Mar2021 at 09:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included fluticasone (MANUFACTURER UNKNOWN) on an unknown date. Prior to 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 17Mar2021 at 07:00AM the patient experienced tingling in both hands and arms, likely tingling in feet too. The patient has not received any treatment for the events tingling in both hands and arms and likely tingling in feet. The clinical outcome of event tingling in both hands and arms, likely tingling in feet too was recovered on an unknown date in Mar2021. No follow-up attempts are possible. No further information is expected.
36 2021-06-30 hot flush Lightheaded; Nausea; Hot flush; Fatigue; Chills; This is a spontaneous report received from a contac... Read more
Lightheaded; Nausea; Hot flush; Fatigue; Chills; This is a spontaneous report received from a contactable pharmacist. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8270) via an intramuscular route of administration in the left arm the 23Mar2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported and there were no known allergies. The concomitant medications were unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 23Mar2021 at 12:00, the patient experienced lightheaded, nausea, hot flush, fatigue and chills. The patient did not receive any treatment for the 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 the lightheaded, nausea, hot flush, fatigue and chills was resolving at the time of this report. No follow-up attempts are needed. No further information is expected
36 2021-07-03 flushing, tingling Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Was pale and sweating, had a significant other that drove him home from the store
36 2021-07-05 cold sweat Fever, joint paid, headache, cold sweats, nausea, fast breathing, no energy. I have been trying to s... Read more
Fever, joint paid, headache, cold sweats, nausea, fast breathing, no energy. I have been trying to stay hydrated. I've taken Tylenol. 1200 mg. Fever and other side effects still persist.
36 2021-07-05 flushing Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Bradycardia-Severe, S... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Bradycardia-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient had not eaten all morning and felt very anxious about vaccine prior to administration.
36 2021-07-08 bell's palsy Bell?s palsy
36 2021-07-08 burning sensation, weakness About 2 weeks after getting my first Pfizer shot, I woke up with burning left-sided substernal chest... Read more
About 2 weeks after getting my first Pfizer shot, I woke up with burning left-sided substernal chest pain that persisted for hours. When I went to get up to use the bathroom that night, I passed out. For the next 1-2 months, I had exertional left-sided chest pain that then resolved spontaneously. I'm a 37-year-old male (was 36 at the time of symptoms), thin (BMI 23), exercise regularly, and take just one medication (the lowest dose of atorvastatin for mild dyslipidemia). At the time I had these symptoms, the phenomenon of myocarditis after the Pfizer vaccine had not been widely reported, so it never occurred to me that my symptoms could have been due to this. So I ended up receiving the second Pfizer vaccine about 3 weeks after the first dose. My symptoms after the second dose were similar to others around me (24 hours of severe myalgias/chills/weakness followed by several days of not feeling like myself). Now (6 months later), I feel essentially back to normal.
36 2021-07-08 pain in extremity A little bit of arm soreness
36 2021-07-10 pain in extremity 1) 4 days following second dose, calf pain developed that did not resolve. After 2 weeks of unresolv... Read more
1) 4 days following second dose, calf pain developed that did not resolve. After 2 weeks of unresolved calf pain a distal DVT in the right leg was detected by ultrasound at the ED. 2) Within a few days following the second dose, sudden onset hearing loss was detected in the left ear. Accompanied by tinnitus, and aura fullness. There was no vertigo or dizziness episodes
36 2021-07-11 tingling About 30 min after being vaccinated with second dose Pfizer, patient reported feeling dizzy with tin... Read more
About 30 min after being vaccinated with second dose Pfizer, patient reported feeling dizzy with tingling sensation in fingers. Ice pack applied to back of neck, BP taken x2 (high with no known history of HTN)- patient refused a third reading, and juice/water was refused by patient as well. He stated his current symptoms were similar to what happens prior to anaphylaxis with shellfish. Transported to
36 2021-07-11 trigeminal neuralgia Acute trigeminal neuralgia - systemic immune reaction, possibly vasculitic
36 2021-07-13 pain in extremity Site: Pain at Injection Site-Severe, Additional Details: Per pt complaining of arm pain from shot. L... Read more
Site: Pain at Injection Site-Severe, Additional Details: Per pt complaining of arm pain from shot. Left arm feels weaker, causing neck pain now. He will follow up with MD
36 2021-07-13 pain in extremity After the first shot I had extreme soreness in my arm/shoulder. The pain began the 2nd day and was o... Read more
After the first shot I had extreme soreness in my arm/shoulder. The pain began the 2nd day and was only sore at first, by the end of that day I could not lift my arm higher than my shoulder. This lasted another day and then by the 4th day after the shot I could move my arm normally but it was still sore until the 6th day after the shot. After the second shot I began experiencing a lot of join pain in my hands and fingers and my feet and toes. The pain was mild, maybe a 4 out of 10 and lasted for about 3 days. Earlier this year I had similar issue's with joint pain that lasted a while but it had been gone for almost two months before returning immediately after the second shot.
36 2021-07-15 bell's palsy Bell's Palsy on the left side of my face. Started with my upper lip on the left side, spread to the... Read more
Bell's Palsy on the left side of my face. Started with my upper lip on the left side, spread to the left side of my mouth the next day, and several hours later I am having trouble trying to close my left eye.
36 2021-07-19 tingling Tingling in right 15 days first dosage.; This is a spontaneous report from a contactable other Healt... Read more
Tingling in right 15 days first dosage.; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 02Jan2021 16:00 (at the age of 36-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included blood pressure increases (high bp), ocular migraine. The patient had no known allergies. Concomitant medication(s) included amitriptyline; amlodipine, both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient had no covid prior vaccination and not tested post vaccination. The patient experienced tingling in right 15 days first dosage since 17Jan2021 12:00. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the event. Outcome of the event was not recovered. Information on the lot/batch number has been requested.
36 2021-07-20 pain in extremity Headache; Arm soreness; Mild body aches; Light headedness/ got dizzy easily; Thirst; Got dizzy easil... Read more
Headache; Arm soreness; Mild body aches; Light headedness/ got dizzy easily; Thirst; Got dizzy easily; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 01Apr2021 at 09:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. No concomitant medications were taken by the patient. 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 patient did not receive any other medications within 2 weeks of vaccination. On 01Apr2021 at 13:00 the patient experienced headache, arm soreness, mild body aches, light headedness, got dizzy easily and thirst. 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 events. The clinical outcome of the events headache, arm soreness, mild body aches, light headedness, got dizzy easily and thirst were recovered on an unspecified date in Apr-2021. No follow-up attempts are needed. No further information is expected.
36 2021-07-20 tremor, flushing, weakness, unresponsive to stimuli Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Paramedics were called, they assessed, but did not take the patient with them. He had recovered
36 2021-07-27 weakness, numbness, tingling tingling in his hands; fingers felt numb; weakness in the left arm/shoulder; significant strength lo... Read more
tingling in his hands; fingers felt numb; weakness in the left arm/shoulder; significant strength loss; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0176; Expiration Date: Aug2021), dose 1 via an unspecified route of administration on 06May2021 (at the age of 36 years old) as dose 1 single, and dose 2 via an unspecified route of administration, administered in Arm Left on 27May2021 (Batch/Lot number was not reported) as dose 2 single both for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. On an unspecified date in May2021 patient had significant strength loss. on an unspecified date patient experienced tingling in his hands, fingers felt numb, weakness in the left arm shoulder. He works as a personal trainer and works out all the time. used to shoulder press 145 pounds and now it's about 95 pounds. did some range of motion exercises today and he just everything go by in May thinking it will get better, but this has been going on the whole month.thought he would give it a week or two to get better, but it hasn't. does range of motion exercises to see how fast he was, and his right arm goes up over the head effortlessly, but the left arm he has to concentrate really hard once it goes above the head. He took 6-pound weights in each hand to do arm curls and lift it straight over his head side to side and about the third time left arm felt like he was doing 30 pounds or something. He was struggling with the left arm. After that he took a chair that maybe weighed 10-12 pounds from the ground straight over his head with his right arm and then switched to his left arm and he could only get it to about chin level. It felt like his brain is not computing and it has to be a nervous system thing. He knows he could usually do that, but the left arm was struggling trying to keep up. States the loss in strength all started about a week after the second shot. That's when he noticed he went from 145 pounds down to 125 pounds and was able to that for about a week and then he had to go down and now at about 95 pounds and even that is a struggle. Has no problems with the right arm going up; it's the left arm and even now the weight bar is starting to tilt. His left arm used to be the strongest arm. did 60-pound curls with each hand and now can only do 25 pounds on the left arm. the right arm has stayed the same. No other vaccines given the same days as Covid 19 vaccines and no problems with vaccines in past. He had to get the vaccine to work even though he did not feel like it was very trustworthy and now he fully regrets getting it, but he needed to get it in order to work in . No other pain but did have some tingling in his hands and fingers felt numb, but he does not have that anymore, it's just the weakness in the left arm/shoulder. His grip is still there, and he is still able to pick up things and his fingers feel fine. Any movement over the head straight up is way more difficult than it should be. No events required visit to Emergency Room/ physician office and no prior vaccinations received. The outcome of the event significant strength loss was not recovered, weakness in the left arm/shoulder was unknown and outcome of all other events was recovering.
36 2021-07-27 pain in extremity Slightly reduced range of motion in arm.; Slight soreness in vaccinated arm; This is a spontaneous r... Read more
Slightly reduced range of motion in arm.; Slight soreness in vaccinated arm; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep7533), via an unspecified route of administration in the right arm on 04Apr2021 at 12:45 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and other allergies. 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 18:30, the patient experienced slight soreness in vaccinated arm and slightly reduced range of motion in arm. 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 the reported events. The clinical outcome of the events slight soreness in vaccinated arm and slightly reduced range of motion in arm were recovered on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.
36 2021-07-27 throat numbness, numbness facial numbness changed locations, moving to below tongue and some of throat; facial numbness change... Read more
facial numbness changed locations, moving to below tongue and some of throat; facial numbness changed locations, moving to below tongue and some of throat; sporadic pain; headache; feeling of brain freeze; injection site pain; general fatigue; facial numbness; Had to stop lecturing due to facial muscles sore; This is a spontaneous report from a contactable consumer. A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6200; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 26Feb2021 08:15 hr (at the age of 36-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included obesity, plantar fasciitis, sleep apnea from an unknown date and unknown if ongoing. Concomitant or other medications in two weeks, other vaccine in four weeks, COVID prior vaccination, if COVID tested post vaccination was reported as none. The patient previously took Sulfa drops and experienced hypersensitivity (known allergies). The patient experienced feeling of brain freeze, injection site pain, general fatigue, facial numbness on 26Feb2021, sporadic pain, headache on 27Feb2021, facial numbness changed locations, moving to below tongue and some of throat on 28Feb2021, had to stop lecturing due to facial muscles sore on unspecified date in Feb2021. Adverse events start time was reported as 08:30 hr on 26Feb2021. It was reported that adverse events on day 1 could be described as the feeling of brain freeze after drinking a smoothie too quickly about 20-25 minutes after injection, leading to injection site pain and general fatigue which has mostly continued and what could best be described as facial numbness. Day 2 most of face was numb, sporadic pain, injection site pain, fatigue, headache. Day3 facial numbness changed locations, moving to below tongue and some of throat, injection site pain and fatigue. Day 4-6 changing facial numbness and pain around face and top of head. Had to stop lecturing due to facial muscles sore (as if you hurt from laughing, but constant). Day 7 some fatigue and facial numbness and pain. There were no signs of stroke, no facial droop, nor uneven paralysis. No treatment was given for the events. Clinical outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
36 2021-07-28 tingling, trigeminal neuralgia I am now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms; ... Read more
I am now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms; I am now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms; some jaw pain; high blood pressure; lips tingle, chin tingles; lips tingle, chin tingles; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 08:30 (Lot Number: EN6205), at the age of 36-year-old, as single dose for COVID-19 immunisation. Medical history included sleep apnea, known allergies Sulfa drugs. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 26Feb2021 at 08:30 AM (Lot Number: EN6200) and 20-25 minutes after injection, roof of mouth cold like brain freeze, sore injection site. 1 Hr after jab: facial tingling, growing more severe - by 8 pm (12 hours) much of the face was numb. Nurse recommended Benadryl and stated that patient only need to come in if it affects his breathing. Right toe tingly, facial numbness. By 27Feb2021: throat, under tongue, and neck numb. 28Feb2021: hemifacial numbness, back of head cold and tingly. By 01Mar2021: hemifacial muscle spasms began and have continued today, headaches are common. On 19Mar2021, patient received Jab 2 (Lot EN 6205) and experienced much less severe reaction. He was told by the nurse to take Benadryl and Pepcid 1 hour before the jab, which he did. 10 minutes after jab: lips tingle, chin tingles. 15 minutes after: some jaw pain and high blood pressure (requiring a standby nurse to have him lie on a stretcher). As of 15Jul2021 he was now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms. The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Patient was currently on Azetazolamide for Intracranial Hypertension. The outcome of the events was not recovered. No COVID prior vaccination. No COVID tested post vaccination.
36 2021-07-28 tremor Roughly 5 hours after vaccine experienced chills and shaking/tremors that lasted 1-3 hours.
37 2020-12-31 pain in extremity Typical sore arm similar to flu shot. Following day, had minor low half body aches and chills.
37 2021-01-05 flushing, feeling hot Pt received vaccine at 11:45 and was sitting in observation for 8 minutes when he stated he felt lik... Read more
Pt received vaccine at 11:45 and was sitting in observation for 8 minutes when he stated he felt like he was getting really warm. Pt was put in wheelchair and taken to a room to lay down. Vital signs BP 139/88, P 68, R 20 SP02 98%. Pt face was flush. No signs of SOB or any other symptoms. After 10 minutes patient stated the "hot feeling" was going away. We monitored him for additional 30 minutes and patient was able to sit up without any difficulties or changes in the way he felt. Patient was released to his command with no limitations.
37 2021-01-05 flushing Within minutes patient experienced light headedness, flushing, reports that he felt like fainting a... Read more
Within minutes patient experienced light headedness, flushing, reports that he felt like fainting and he felt his heart racing He was taken to ER and only finding was elevated BP. Pt was interviewed an hour after incident and reported that all sx had resolved. Pt was discharged and came by vaccine clinic to report he had recovered.
37 2021-01-05 numbness, facial paralysis he had some facial drooping then resolving and his hand released an object he was holding, limbs goi... Read more
he had some facial drooping then resolving and his hand released an object he was holding, limbs going numb and he felt like he was having a stroke. This occurred about an hour after his vaccine. in the next few days he experienced severe headaches. All adverse experiences have resolved as of 1/6
37 2021-01-06 pain in extremity A few minutes post-vaccination, the patient developed a splitting headache that radiated from the ne... Read more
A few minutes post-vaccination, the patient developed a splitting headache that radiated from the neck up over the head. He had pain down his arm and leg on the opposite side (as well as itching-arm only)the vaccine was administered in. Nausea developed and became worse as time passed. No injection site reaction or trouble breathing reported. Once patient reported that his muscles hurt and he hurt everywhere EMS was called. The patient was transported to Hospital and discharged prior to the end of the clinic with Tylenol and Tums.
37 2021-01-07 numbness Numbness to right arm; This is a spontaneous report from a contactable nurse (patient) reported for ... Read more
Numbness to right arm; This is a spontaneous report from a contactable nurse (patient) reported for himself. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: PfizerBiontech; lot number: 4c9231) intramuscularly at right arm on 30Dec2020 at 09:45 AM at a single dose (dose number: 1) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was nursing Home/Senior Living Facility. No relevant medical history and concurrent conditions. No known allergies (no 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 experienced numbness to right arm on 30Dec2020 at 03:30 PM. The event was reported as non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The outcome of event was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 included COVID test post vaccination (COVID test type post vaccination: Nasal Swab; COVID test name post vaccination: Color) on 29Dec2020 was negative. No follow-up attempts are possible. No further information is expected.
37 2021-01-07 pain in extremity, feeling hot 7cm diameter area of redness and induration. Mild local soreness and warmth.
37 2021-01-07 pain in extremity Following day, had minor lower body half aches and chills; Following day, had minor lower body half ... Read more
Following day, had minor lower body half aches and chills; Following day, had minor lower body half aches and chills; Typical arm soreness similar to flu shot.; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH 9899), via an unspecified route of administration in the right arm on 29Dec2020 at 15:45 at a single dose as COVID vaccine. The patient had no other vaccines within four weeks prior to the COVID vaccine, was not diagnosed with COVID prior to vaccination, and was not tested for COVID post vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. Past drug history included flu shot. On 30Dec2020 at 10:00 AM, the patient experienced typical arm soreness similar to flu shot. The following day, 31Dec2020, he had minor lower body half aches and chills. The patient received no treatment for the events. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
37 2021-01-07 tingling, flushing FELT FLUSED FEELING, LEFT ARM /LEFT HAND TINGLING - LEFT FACILITY AFTER VITAL SIGNS TAKEN BY EMS ON ... Read more
FELT FLUSED FEELING, LEFT ARM /LEFT HAND TINGLING - LEFT FACILITY AFTER VITAL SIGNS TAKEN BY EMS ON SCENE
37 2021-01-08 hypersensitivity of all senses, hot flush Extreme fatigue/muscle soreness and hypersensitive skin concurrent with alternating hot flashes with... Read more
Extreme fatigue/muscle soreness and hypersensitive skin concurrent with alternating hot flashes with profuse sweating and cold flashes with shivering.
37 2021-01-09 tingling, face paralysis Facial weakness (left side), lip paralysis (left side), decreased sense of taste, eye leakage (left ... Read more
Facial weakness (left side), lip paralysis (left side), decreased sense of taste, eye leakage (left side), facial tingling (left side). Onset 1/4/2021 with symptoms worsening through the week. Noticeable lip paralysis starting on the afternoon of 1/10/2021. 2nd vaccine received at 8:00AM on 1/10/2021.
37 2021-01-11 feeling hot, flushing felt hot; flush; light headed; heart rate elevated; fever; This is a spontaneous report from a conta... Read more
felt hot; flush; light headed; heart rate elevated; fever; This is a spontaneous report from a contactable consumer (patient). This 37-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EH9899) via an unspecified route of administration at right arm on 06Jan2020 12:15 PM at single dose for COVID-19 immunisation. Medical history included known allergies to Penicillin and Hashimoto's thyroiditis. Concomitant medications included atorvastatin and clarithromycin (CLARITIN). The patient previous took Amoxicillin and Azithromycin, both experiencing allergies; the 1st dose of flu shot on 21Dec2020 at arm left. Within 5 minutes of injection, the patient felt hot, flush, light-headed and heart rate elevated from 06Jan2021 at 12:30 PM. The patient was under observation and the nurse laid him down in a room. The patient was monitored vitals with a doctor. Symptoms subsided and stopped by 30 minutes post injection. The patient felt normal and fine after fever. The patient did not have any symptoms himself. No treatment was received. 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 all events was recovered.
37 2021-01-11 flushing Facial flushing, tingling/tickle in throat
37 2021-01-12 face paralysis, bell's palsy, facial paralysis Pfizer-BioNTech COVID-19 Vaccine EUA? 1st vaccine 12/21/2020, 2nd vaccine 1/10/2021 ED visit 1/11/2... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA? 1st vaccine 12/21/2020, 2nd vaccine 1/10/2021 ED visit 1/11/2021: Chief Complaint: Pt. reports facial droop that started at 1200 yesterday. Pt. reports that he is unable to raise left eyebrow or control left side of face/lips. Pt. states that symptoms began approx. 4 hours after his COVID booster was administered Patient, 37 y.o male with hx DM, presents with left sided tongue numbness that began 2 days ago and left sided facial droop that began yesterday around noon. He reports difficulty raising his left eye brow and controlling the left side of his face. Pt also reports slight hearing and visual changes on the left side and tearing from the left eye. He denies any extremity weakness, rashes, and any other concerns at this tiem. Clinical Impression: Final diagnoses: Bell's palsy (Primary) Patient's history, physical exam and clinical work-up are consistent with Bells Palsy. Patient's symptoms of unilateral facial weakness with forehead involvement of relatively sudden onset are c/w peripheral seventh nerve palsy (lack of nasolabial folds, unfurrowing of the forehead and drooping corner of the mouth). Patient has not had recent rashes, arthralgias, or fevers or exposure to ticks. The ear canal, mouth and parotid gland are otherwise normal. The patient has been instructed to complete a 7 day course of oral steroids and anti-virals, and to use copious amounts of re-wetting eye drops, tape the affected eyelid while sleeping and follow up a primary care physician. The patient is to return to the ER immediately if symptoms progress or the patient becomes concerned for any reason.
37 2021-01-12 numbness Pfizer-BioNTech COVID-19 Vaccine EUA: Eight hours following vaccination patient developed numbness o... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Eight hours following vaccination patient developed numbness of left the lower face. No other symptoms documented. Numbness resolved without intervention within one week of vaccination.
37 2021-01-12 tremor Violent chills starting at 9p, appx 13 hrs after injection, followed by fevers, shakes, myalgia, art... Read more
Violent chills starting at 9p, appx 13 hrs after injection, followed by fevers, shakes, myalgia, arthralgias, malaise. Pounding headache for appx 12 hrs until the following morning, Appx 12 hrs after symptoms began was left with myalgias, arthralgias and fatigue that lasted another 24 hrs. Fevers as high as 101.6 during the first 12 hrs when symptoms began.
37 2021-01-13 pain in extremity the patient's arm has been giving him pain since the vaccine shot; This is a spontaneous report from... Read more
the patient's arm has been giving him pain since the vaccine shot; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on 05Jan2021 at 13:15 on the left arm at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient has no 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 vaccine. The patient's arm has been giving him pain since the vaccine shot on 05Jan2021 at 14:30. The patient did not receive treatment for the adverse event. Outcome of the event was recovering. Information on the lot/batch number has been requested.
37 2021-01-15 feeling hot Headache, body ache, feeling feverish/hot, some itchiness.
37 2021-01-15 tremor shaking chills and high fever over 102
37 2021-01-18 tingling, cold extremities Pt reported having a "burning sensation" in his throat about 11 min post vaccine. Denied any shortn... Read more
Pt reported having a "burning sensation" in his throat about 11 min post vaccine. Denied any shortness of breath, swelling of lips or tongue and had no evidence of rash. He also denied any difficulty swallowing . He did report tingling and "cold" feeling in his hands. Pts BP was elevated to 148 / 98 ( both by machine and manually) with HR 87, He drank some juice, but refused any Benadryl.
37 2021-01-19 pain in extremity The day after the vaccine he developed arm soreness, fevers, chills and headaches.
37 2021-01-21 weakness Nausea vomiting cold chills fever weakness dizziness onset was 3 hrs after vaccine and the symptoms ... Read more
Nausea vomiting cold chills fever weakness dizziness onset was 3 hrs after vaccine and the symptoms stopped 24 hrs later
37 2021-01-21 feeling hot Later that night on the day I got my injection, I started to get chills. After a few hours the chill... Read more
Later that night on the day I got my injection, I started to get chills. After a few hours the chills turned into a feeling of being warm. I had my wife check my temp 2-3 times and it was 100.3. I also had a headache.
37 2021-01-21 pain in extremity Strong Headache, Strong Body Aches, Pain while urinating, heavy congestion and discharge, pain in va... Read more
Strong Headache, Strong Body Aches, Pain while urinating, heavy congestion and discharge, pain in various areas of my body which moved throughout the day (jaw, arm, etc), upset stomach
37 2021-01-23 muscle spasms Fever , myalgia, back spasm , fatigue, lymp node swelling
37 2021-01-24 hot flush, weakness For three days after the vaccine I would alternate between chills and hot flashes. I also had body a... Read more
For three days after the vaccine I would alternate between chills and hot flashes. I also had body aches all over. I was lethargic, just drained of energy. I did not have a fever at anytime. Three days after the vaccine I developed a scratchy throat and cough.
37 2021-01-25 inability to speak, numbness EE reports he received pfizer vaccine on 1/21/21. He noted extreme fatigue on 1/22/21 and today 1/2... Read more
EE reports he received pfizer vaccine on 1/21/21. He noted extreme fatigue on 1/22/21 and today 1/23/21 noted an inability to form words and talk while on the phone, dizzy, tongue is half numb, and notes sweating. EE advised to f/u with ER for assessment. Consult with Dr. e-mail was sent alerting her to this reaction. MAJ follow up on 1/26: ED record reviewed. EE had vaccine injected on 1/21 and experienced chills and nausea on 1/22. On 1/23 he had 1-2 minutes of aphasia and R jaw numbness. ED evaluation that afternoon revealed a well-appearing adult with normal vital signs and neurologic exam. Assessment by ED physician was that this was not a stroke or transient ischemic attack but might be a vaccine-related adverse event. The ee was referred for follow-up with his PCP, Dr. , who can be emailed if further follow up information is needed. I suspect the ee became dehydrated from vaccine-related nausea and that this was the cause of his transient neurologic symptoms.
37 2021-01-25 numbness Patient experienced headache, shortness of breath, left side arm and leg numbness and mild diarrhea ... Read more
Patient experienced headache, shortness of breath, left side arm and leg numbness and mild diarrhea after one hour receiving the Covid 19 vaccine. This is the second dose.
37 2021-01-25 tingling, feeling cold Day of - toes and fingers started tingling, extreme fatigue, light-headed Next day - extreme cold sy... Read more
Day of - toes and fingers started tingling, extreme fatigue, light-headed Next day - extreme cold symptoms - fever, light-headed, stomach ache, stuffy nose, body aches, right deltoid (where shot was administered) hurt badly to move at all Day three - today - arm is still sore but no other side effects at this time
37 2021-01-30 pain in extremity Swollen tongue. Sore arm. Swollen throat
37 2021-01-30 sciatica Severe back pain and left sided sciatica. Symptoms start 24-ish hours after vaccine. No trauma or pr... Read more
Severe back pain and left sided sciatica. Symptoms start 24-ish hours after vaccine. No trauma or prior back conditions. Treated with two courses of steroids, gabapentin, and naproxen without relief. Pending neurosurgical evaluation. Patient had severe back pain for 2-3 days when he had COVID-19 back in December.
37 2021-01-31 feeling hot, muscle spasms 29th Friday January 2021-Body aches, HA, aches-real bad in his bones, runny nose, muscle aches, cong... Read more
29th Friday January 2021-Body aches, HA, aches-real bad in his bones, runny nose, muscle aches, congestion-no sleep Saturday 310th January-Lymph Noes-rt armpit-enlarged-rt neck nodes swollen also, he felt warm all over Sunday 31st January 2021-Very fatigued, BA, muscle cramps, a little congestion Today 1 February 2021-Body aches, taking motrin for his discomforts Reminded if his symptoms get worst-go to the ER, Go to his PCM also if he gets worse-talk to his supervisor if he needs to take off from work
37 2021-01-31 numbness 1/7-1/10 felt tired, 1/11 dizzy, confused, headache, Lt side facial numbess; 1/12 - less dizzy, 10% ... Read more
1/7-1/10 felt tired, 1/11 dizzy, confused, headache, Lt side facial numbess; 1/12 - less dizzy, 10% facial numbness - reduced, little confused - reduced.
37 2021-02-01 pain in extremity A couple days later I began experiencing a slight sore arm. Several days later I had a constant hea... Read more
A couple days later I began experiencing a slight sore arm. Several days later I had a constant headache. Around January 25 I began experiencing non-stop chest pain and on January 27 woke up with severe pain in my arm. I went to the emergency room and was diagnosed with an NSTEMI.
37 2021-02-02 facial paralysis Bells Palsy possible Guillans Bare
37 2021-02-02 pain in extremity it was so faint; he checked his temperature, it was 100.3; Body aches; aching in hips; Chills; littl... Read more
it was so faint; he checked his temperature, it was 100.3; Body aches; aching in hips; Chills; little mild headache; arm started hurting/his arm was so sore; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 19Jan2021 16:00 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were none. The patient on 19Jan2021 at about 4:00PM, got his first dose of vaccine, later clarified as COVID vaccine, and he was very energetic last night, he didn't feel the medicine going in, but today (20Jan2021), the more he was up, the worse he felt, and he checked his temperature, it was 100.3, and his employer said to not come in today, he knew can't get the virus from the vaccine, but this was not a side effect listed on the sheet. He had body aches, his arm, he can't hardly lift it, and last night he was so energetic and felt great, but his arm was so sore throughout the night, it woke him up, and he was aching in hips/aches primarily in his hips, he has hip issues, but was achy in that area. He was also starting to get a little mild headache, it was so faint right now, his symptoms came along the longer he was up, the more he was experiencing things. Primary care doctor's information declined, stated he didn't have one, he moved to another state, and didn't have one yet. Workplace said not to come if temperature was 100.4, but it's so borderline, so they said to stay home. Outcome: he had checked 4 times, and it kept saying 100.3. Overnight, his arm started hurting, but he got up today, and had chills and body aches. His arm was not hurting if he moved his arm, but other than that, he felt like something was there, but didn't ache or anything. The outcome of events faint, chills and headache was unknown, for events temperature was 100.3, body aches, arm hurting, and aching in hips was not recovered.
37 2021-02-03 nerve pain I began having what felt like was nerve and joint pain along my left side of my face and arm. I deve... Read more
I began having what felt like was nerve and joint pain along my left side of my face and arm. I developed a headache and was also nauseous. It went away after about 48 hours.
37 2021-02-03 pain in extremity Arm pain and headaches at 1:30pm on February 4, 2021.
37 2021-02-04 feeling of body temperature change, feeling hot, tingling, discomfort Lightheaded/dizziness; Feeling warm; Uncomfortable tingling sensations that started in my fingers an... Read more
Lightheaded/dizziness; Feeling warm; Uncomfortable tingling sensations that started in my fingers and moved up my arms; Uncomfortable tingling sensations that started in my fingers and moved up my arms; Feeling quite unwell; Strong flu symptoms; Felt very hot/cold; Intense aching; Muscle soreness all over; Inflamed lymph nodes (esp in neck); Some nausea; Internal temp (taken under tongue) was also very low, about 95 degrees; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 20Jan2021 (14:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included naproxen sodium (ALEVE) and cannabidiol (CBD OIL). On 20Jan2021 (14:45), after the vaccination, the patient became lightheaded/dizziness; had started feeling warm; and had uncomfortable tingling sensations that started in the fingers and moved up to the arms. On 20Jan2021, about an hour or two after the vaccination, the patient had begun feeling quite unwell; had strong flu symptoms; was feeling very hot/cold; had intense aching; muscle soreness all over; inflamed lymph nodes (especially in the neck); some nausea; and internal temperature (taken under the tongue) was very low at about 95 degrees. The patient had received treatment for the reported events; blood pressure was taken; and he was given water. The adverse events had required doctor or other healthcare professional office/clinic visit. The outcome of the events, 'lightheaded/dizziness', 'feeling warm', 'uncomfortable tingling sensations that started in the fingers and moved up to the arms', 'feeling quite unwell', 'strong flu symptoms', 'feeling very hot/cold', 'intense aching', 'muscle soreness all over', 'inflamed lymph nodes (especially in the neck)', 'nausea' and 'internal temperature (taken under the tongue) was very low at about 95 degrees', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
37 2021-02-10 pain in extremity Bloody nose, fainting spells, sore arm, insomnia.
37 2021-02-11 tingling Severe joint pain, headaches, paresthesias, severe fatigue, lethargy, difficulty concentrating
37 2021-02-14 weakness Pfizer-BioNTech COVID-19 Vaccine: About 15 minutes after vaccination, patient started to feel tingl... Read more
Pfizer-BioNTech COVID-19 Vaccine: About 15 minutes after vaccination, patient started to feel tingling in throat and also weakness. Paramedic was on site and put patient on EKG monitor. Paramedic administered diphenhydramine 50 mg IV. Patient recovered and left site independently. Patient state no throat tickle or further issues.
37 2021-02-16 bell's palsy, facial paralysis Patient here today with left sided jaw pain starting 2 days ago. He has subsequently had worsening p... Read more
Patient here today with left sided jaw pain starting 2 days ago. He has subsequently had worsening paralysis of the left side of his face. He is not able to fully elevate his left eyebrow, close his left eye, or smile with the left side of his face. He had a COVID 19 vaccine 1 moth ago and was scheduled for his second one today. No word finding difficulty or headache. Diagnosed with Bell's Palsy; treated with prednisone and Valtrex. Instructed to go to ED for loss of vision or evolving symptoms. Wait on second COVID vaccine until prednisone is finished.
37 2021-02-17 pain in extremity left index finger feels like it was jammed; finger was in a lot of pain when moving left or right, e... Read more
left index finger feels like it was jammed; finger was in a lot of pain when moving left or right, even when washing his hands; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male 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 on 03Feb2021 at 19:45 at a single dose on the arm left for COVID-19 immunization. Medical history included patient was diagnosed with COVID-19. Concomitant medications included naproxen sodium (ALEVE) and biotin. On 04Feb2021 at 03:00, the patient stated that his left index finger feels like it was jammed. The patient also stated that his finger was in a lot of pain when moving left or right, even when washing his hands. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The events were assessed as non-serious. Information on the lot/batch number has been requested.
37 2021-02-19 tingling, tremor "Tingling" all over body, slight reddening of the neck and chest area, kept shaking left hand
37 2021-02-22 pain in extremity Early the morning after my arm swole with increased swelling and pain and I treated with OTC Tylenol
37 2021-02-26 migraine Migraine with visual disturbance. Patient has had them before in response to new medication ex escit... Read more
Migraine with visual disturbance. Patient has had them before in response to new medication ex escitalopram.
37 2021-03-02 feeling cold It has now been more than 1 week since vaccination. First couple of days were fine, but starting 2... Read more
It has now been more than 1 week since vaccination. First couple of days were fine, but starting 26-FEB-2021, I've been exhibiting all of the following: Fever - Friday 98, Saturday (3 measures over 5 hours) 99.1, 99.3, 99.4, Sunday 98.5, Monday 99.4 (at night, work up in body aches), Tuesday(97.5), Wednesday 98.5 Chills - mild, 1-3 times. comes and goes through past week. Occurs more at night. Feeling cold - wearing sweat pants, two shirts, long sleeve shirt, sweater, during sleep. Constantly add/remove clothes to regulate temperature. During day, have sweat pants + sweater on 78+ degree weather. Muscle pain - in back, moving daily. First started in right chest and back right shoulder, has now disappeared. Now in middle of back, around spin area, hard and uncomfortable to sleep, taking IB profin helps alleviate pain, 2 to 3 tables over counter. pain in throat around vocal box, could be due to sneezing, slight soreness to touch/aches. Feeling unwell - comes and goes, day starts fine, then around noon/1pm i get super tired and sleep. Sleeping schedule is generally 10PM to 6AM + naps through day Lose stools - from 25-FEB to 27-FEB, cleared up on 29-FEB Coughing - started on 03-MAR-2021, slight about 1 to 3 times an hour. Headache - comes and goes, use IB profin only when trying to sleep, all other times i let it be. Good news: No swelling at injection site No redness at injection site No Swelling at injection site Final notes: Just feeling up an down, not taking anything besides IB profin for pain management. I was going to work everyday pre-shot with out issue. Post-shot, not feeling well enough to report to work out of fear of spreading anything that i got. Weekend immune system. Slightly grumpy demeanure since sick and interrupted sleep patterns.
37 2021-03-02 feeling hot I received my first dose of the Pfizer vaccine at about 4:05 or 4:10 PM today (Wed, Mar 3, 2021). Ri... Read more
I received my first dose of the Pfizer vaccine at about 4:05 or 4:10 PM today (Wed, Mar 3, 2021). Right away I had the following symptoms briefly: chills and blurred vision. Around 4:20 or so I left in my vehicle. Shortly after, I had a few chills. I needed to use the restroom and pulled into a gas station. After starting to go the bathroom, I quickly began to feel warm and my vision began to blur. The next thing I knew, I opened my eyes laying on the bathroom floor. I then left the restroom and headed to my vehicle where I noticed I had perspiration on my forehead and was really warm. Over the next hour or so I experienced chills frequently. They have since subsided.
37 2021-03-06 pain in extremity Patient got his second dose of the Pfizer Covid vaccine at ~1300 on 3/5/21. On 3/6/21, he developed... Read more
Patient got his second dose of the Pfizer Covid vaccine at ~1300 on 3/5/21. On 3/6/21, he developed fever, dizziness, temp up to 101. He experienced dizzy spells especially when he got up. He is able to walk with help. He took tylenol 1000 mg morning and evening on 3/6/21. Patient stated the worst symptom is the dizziness. On 3/7, patient had a temp of 100.2. He had pain and swelling in axilla where he got second vaccine and along his side. Patient reported the dizziness is getting a little better and is not constant. In the afternoon, his temperature went up to 102.9 F. Patient's PCP recommended that he be evaluated in the emergency department. Patient was evaluated in the emergency department. He received a liter of normal saline and was subsequently discharged.
37 2021-03-07 migraine Insomnia; 103 Fever; Chills; Muscle and Total body pain; Muscle and Total body pain; Profuse vomitin... Read more
Insomnia; 103 Fever; Chills; Muscle and Total body pain; Muscle and Total body pain; Profuse vomiting; Migraine; Tiredness; Stomach pain; Diarrhea; This 37- year-old male patient contactable consumer (reported for himself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot El3247), via an unspecified route of administration, on 31Jan2021 at 10:00 AM (at the age of 37-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines on the same day or in the past 4 weeks. The patient has allergy to Ceclor and Cephalosporin. The patient has no relevant medical history and is not taking any concomitant medications. On 04Feb2021 at 5:00PM, the patient experienced 103 Fever, Chills, Muscle and Total body pain, Profuse vomiting, Migraine, Tiredness, Stomach pain and Diarrhea, Insomnia. The patient did not receive treatment for the events. The clinical outcome of the events 103 Fever, Chills, Muscle and Total body pain, Profuse vomiting, Migraine, Tiredness, Stomach pain and Diarrhea, Insomnia was not recovered. It was reported that since the vaccination, the patient had been tested for COVID-19 via nasal swab on 05Feb2021 with a negative result.
37 2021-03-09 weakness The day of the vaccine I was feeling normal until later on in the afternoon when I started woozy a... Read more
The day of the vaccine I was feeling normal until later on in the afternoon when I started woozy and a bit weak. The next day Saturday I started feeling a bit weak and not sick but also as if something was wrong. I also had some throat discomfort. Sunday was similar but some lingering headaches began. I also felt weaker and some slight muscle aches. Sunday night I slept 10 hours (I had had seen friends on Saturday evening for a birthday so i didn?t get much sleep). Monday came around and the throat discomfort persisted along with the lingering headaches and slight weakness. By then my blood sugar levels were getting higher and I would not be able to lower them with the number of units of insulin I normally take like I used to prior to vaccine injection (this happens when my body is sick or reacting to something) Monday night I fell asleep and woke up at 3 am with a piercing headache ( the most painful headache I?ve ever felt) along with radiating pain to my neck and drenched in sweat. It felt like I had just gotten out of a shower but wet with sweat. My body and bed were soaked. I barely stumbled to my counter to take an Advil and Xanax ( prescribed) to ease the pain of the headache luckily after an hour I fell asleep. When I woke up on Tuesday I still experienced weakness and a woozy feeling like I?m sick but really wasn?t. I was getting some chills and hot flashes but did not develop a fever. Tuesday evening I took an Advil before bed to try to avoid the painful headache. I again woke up at 3 am with no headache, but once again drenched and soaked in sweat. I had to sleep on the other side of my bed. I drank water and took an Advil and Xanax and managed to fall asleep. From then on, on Wednesday and forward I was waking up with sweats but they were getting better. I did notice extreme levels of dehydration during the day and night (I never had them before) a heart rate which was at 100bpm resting and blood sugar that not decrease even when I injected 3x my normal insulin amount. Again, this has happened a couple of times in the past only when I?ve been sick or my body has been reacting to something. It was very alarming. Nothing that I took lowered my heart rate nor did 3-4x the amount of insulin lower my blood sugar. I had the lingering headaches still and just felt very worn out and achey. It?s not Wednesday 3/10 and thankfully my heart rate and blood sugar stabilized over the last 2/3 days and I am not waking up drenched in sweat. At all as of last night. These affects were very concerning and alarming. I got anxiety and a lot of tension which I?m sure did not help. This all lasted 8-9 days from the time of injection. Lastly the injection site on my arm does not look normal. It looks like there are some bruise spots and it seems like it may be swollen (looks bigger than before)
37 2021-03-09 hot flush, weakness Fatigue, weakness, hot flashes, pain in left shoulder within 24 hours of shot, and woke up drenched ... Read more
Fatigue, weakness, hot flashes, pain in left shoulder within 24 hours of shot, and woke up drenched in sweat 36 hours after the shot. 48 hours after the shot was still feeling fatigue and weakness, although it had subsided during the day. Face was red and was sweating 48 hours after the shot. Symptoms had mostly subsided within 72 hours.
37 2021-03-09 hot flush Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 2/28/2021 7:38 AM Expan... Read more
Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 2/28/2021 7:38 AM Expand AllCollapse All COVID VACCINE CLINIC 2/26/2021 Patient: Date: 2/26/2021 Subjective is a 37 y.o. male who was seen at COVID 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 flush feeling with chest pain to L lower chest. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. PMH: none. Ate a "big baked potato" about an hour an half before coming in . ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, ear pain, sore throat, frequent throat clearing, eyes itching, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, muscle aches, joint pain, dizziness and headaches No vision changes: + lightheaded. : Previous Reactions: none Objective Vitals Vitals: 02/26/21 1624 02/26/21 1635 BP: 137/88 123/73 Pulse: 59 62 SpO2: 100% 100% Physical Exam Constitutional: General: He is not in acute distress. Appearance: He is well-developed. He is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: General: Right eye: No discharge. Left eye: No discharge. 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. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: Mental Status: He is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Attention and Perception: Attention normal. Mood and Affect: Mood is anxious (slightly). Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Chest pain and symptoms resolved after taking off mask and eating/drinking. Assessment/Plan Treatment included: water and snacks 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) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Monitored for approx 15 minutes. Pt greatly improved. CP resolved within 1 minute of being in the bay after drinking. VS stable/improved. Pt ambulated out of the medical bay w/o assistance. Recommended protein based food and hydration 30 minutes prior to next vaccination. Follow up with pcp as needed. Pt voiced understanding and is appreciative of today's evaluation. APRN Electronically Signed 2/26/2021 4:28 PM
37 2021-03-10 feeling hot I started feeling sick around 8:00 that evening - more than just sore. I ended up with fever of 102 ... Read more
I started feeling sick around 8:00 that evening - more than just sore. I ended up with fever of 102 by 11:00 or midnight; chills and burning up and what prompted me to call my doctor, in the middle of the night, I have a watch with heart rate monitoring and it had woken me up with signal of abnormal heartrate. It was over 130 (normal rate is between 55 and 60 during sleep ) and I had a telemed visit and Dr. said to take Ibuprofen after 24 hour mark. The only other side affect, my bladder side was feeling small and I had to pee every hour. Ibuprofen helped break the fever. The symptoms were resolved by about the following night. My stress level measured by my watch was back in the normal range after I woke up the second morning.
37 2021-03-14 pain in extremity Pt developed sore arm, body/muscle aches, fatigue, malaise, insomnia, sour stomach
37 2021-03-15 bell's palsy, facial paralysis Bell?s Palsay
37 2021-03-17 flushing I began getting very flush, was short of breath, and an increased heartrate.
37 2021-03-18 flushing Well I?m alive. It started about 45 minutes after taking the vaccine. It began as heavy salivating a... Read more
Well I?m alive. It started about 45 minutes after taking the vaccine. It began as heavy salivating and turned into a numb tongue. I have never had an allergic reaction, so didn?t pay much attention to it. After returning home I became severely lightheaded and almost passed out. I immediately took a Benadryl and Motrin. Then my heart rate shot up to 160BPM according to my smart watch and maintained that for around 5 minutes. The home medicine helped it to subside, but the same feelings would return in moderate waves. By 2pm, I decided I should seek professional help and was taken to the ER by a family member. By this time I had moderate chest and jaw was very tight. At the ER I was monitored for 1 hour and then given an IV injection of Benadryl, Pepcid, and Decadron(steroid). I immediately get relived and well. I was released from the ER around an hour later and sent home with a prescription of Benadryl, Pepcid, and Prednisone Oral Steroid. I have since had a few different side effects like chest pain, extremely flushed face, and low grade fevers. The medicine taken at home immediately stopped the face flushing.
37 2021-03-21 hot flush 11:38 AM - Hot flash over chest, arms, neck, and face. Elevated heart rate and anxiety that some thi... Read more
11:38 AM - Hot flash over chest, arms, neck, and face. Elevated heart rate and anxiety that some thing bad was going to happen. Throat irritation and having the feeling to continuously clear throat. Labored breathing. 11: 55 AM - Hot flash over chest, arms, neck, and face. Elevated heart rate and anxiety that some thing bad was going to happen. Throat irritation and having the feeling to continuously clear throat. Labored breathing. 12:01 PM - Throat irritation. 12:24 PM - Took benadryl. 1:09 PM - No symptoms.
37 2021-03-21 speech disorder, feeling hot, involuntary muscle movements Patient started breathing heavily a few minutes after receiving the vaccine, was able to say words n... Read more
Patient started breathing heavily a few minutes after receiving the vaccine, was able to say words not full sentences. said he was feeling hot. he lost muscle control and uncontrollably urinated. EMR was contacted; patient retained muscle control and got back to normal in about 2 minutes after the start of the adverse events. and was able to walk with the EMR outside to get medical check.
37 2021-03-24 bell's palsy developed Bells Palsy on the left side of my face; eye irritation; lack of blinking; stiffness in mo... Read more
developed Bells Palsy on the left side of my face; eye irritation; lack of blinking; stiffness in mouth and jaw; This is a spontaneous report from a contactable consumer. . A 37-years-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN 6205) via an unspecified route of administration in arm left on 06Mar2021 17:15 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED MAGNESIUM CARBONATE]. The patient had no known allergies. The patient was not tested for COVID prior vaccination. The patient experienced facial paralysis, eye irritation, lack of blinking, stiffness in mouth and jaw. The patient underwent lab tests and procedures which included corneal reflex decreased, sars-cov-2 test: negative on 15Mar2021. Therapeutic measures were taken as a result of events with steroids. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
37 2021-03-24 feeling hot Vaccinated at 0820. Around 1800 same day, felt very tired suddenly and developed mild headache and m... Read more
Vaccinated at 0820. Around 1800 same day, felt very tired suddenly and developed mild headache and malaise. Went to bed early around 2030. Woke up feeling better next day. Still had a mild headache. Some soreness when lifting arm that vaccine was received in. Ate breakfast at 0730 and immediately felt very hot, like flushed. Lasted around 20 minutes, mainly subsided now. Took acetaminophen.
37 2021-03-25 numbness Facial numbness, onset approximately 45 minutes-1 hour after vaccine dose. Not full numbness, still ... Read more
Facial numbness, onset approximately 45 minutes-1 hour after vaccine dose. Not full numbness, still had some feeling but was very concerning. Worst numbness started to subside after about 1.5 hours but linger effects lasted until bedtime (5 hours) and were mostly gone after waking up the next day.
37 2021-03-25 pain in extremity PATIENT EXPERIENCING SEVERE ITCHINESS OVER GENERALIZED BODY, MORESO ON TORSO, HANDS AND FEET. PATIEN... Read more
PATIENT EXPERIENCING SEVERE ITCHINESS OVER GENERALIZED BODY, MORESO ON TORSO, HANDS AND FEET. PATIENT ALSO EXPERIENCING LEFT ARM PAIN AND WEAKNESS EVEN WITH VACCINATION TO THE RIGHT DELTOID.
37 2021-03-26 migraine, inability to speak Starting 4 days later, migraine to where I couldn't work, muscle and joint pain, body aches, fever, ... Read more
Starting 4 days later, migraine to where I couldn't work, muscle and joint pain, body aches, fever, chills,
37 2021-03-27 pain in extremity Right after receiving the vaccine, I had some minor arm soreness, which went away. I experienced no ... Read more
Right after receiving the vaccine, I had some minor arm soreness, which went away. I experienced no other adverse effects until the morning of March 21, when I woke up with a significant feeling of disequilibrium. I had never experienced something like this before; when I was stationary I felt fine, but when I started to move my sense of balance was noticeably off. I stumbled around my apartment for a bit before heading to Urgent Care, where I was diagnosed with Benign Positional Vertigo.
37 2021-03-28 pain in extremity Sore arm the day after the injection. Like, more than any other shot or vaccination I've ever gotten... Read more
Sore arm the day after the injection. Like, more than any other shot or vaccination I've ever gotten.
37 2021-03-29 weakness Extreme fatigue. Joint pain. Muscle aches. Extremely low energy/quickly depleted energy levels.
37 2021-03-30 depressed level of consciousness 0patient felt light headed and was unconscious for approximately 20- to 30 seconds. He told us he ha... Read more
0patient felt light headed and was unconscious for approximately 20- to 30 seconds. He told us he has not had any breakfast that day. he said he normally feels light headed after a vaccine but not to the extent of passing out. He was given soda and water for fear of low blood sugar. he was partially responsive and communicative but diaphoretic . 911 came in to assess him but since he was getting better he refused to go to the hospital with them
37 2021-03-30 feeling hot, discomfort Dehydration; perceived fever. I actually did not have any fever when I checked.; I am toughing it ou... Read more
Dehydration; perceived fever. I actually did not have any fever when I checked.; I am toughing it out but it was so uncomfortable; This is a spontaneous report from a contactable consumer (patient himself). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 11Mar2021 08:30 am (at age of 37-year-old) (Lot Number: EN6203) at single dose for COVID-19 immunisation. Medical history included obesity and allergic to Penicillin. The patient was diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The patient experienced dehydration and perceived fever.The patient actually did not have any fever when he checked. The patient reported 'I am toughing it out but it was so uncomfortable I wanted to make sure I reported it. I feel near where I did my worse days of COVID when I was on oxygen'. The events start date was 12Mar2021 02:00 am. The events were reported as non-serious. No treatment received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not resolved. .
37 2021-03-30 feeling hot Pfizer COVID-19 Vaccine EUA Patient received Dose 1 Pfizer vaccine at 1240. Pt started not feeling ... Read more
Pfizer COVID-19 Vaccine EUA Patient received Dose 1 Pfizer vaccine at 1240. Pt started not feeling well, was taken back to medical observation. Pt with grey apperance, not really comprehending commands, sweaty and hot, started to undo his jacket and flannel shirt. Patient started to go in and out of conciousness and was lowered to the floor. Pt became unconscious. Sternal rubs were performed and patient was arousable. Patient began to have generalized clonic seizure, patient was placed in left lateral decubitus position. EMS was called. BP 97/55, SpO2 100%, HR 98. Patient does have history of seizures and is not on any medications for these seizures. 1335: 75/50, 88, 100% (RA), two more additional seizures witnessed. Patient able to regain consciousness between seizures was alert and able to answer questions appropriately. 1340: 18g IV started to left AC. NS hung to open gravity, good flow. 1345: EMS arrived and assumed care, patient A&O x 3. Transported to the hospital. Reporter does not have access to hospital's health records. Bilateral breath sounds CTAB, no swelling of the face/lips/tongue or rash.
37 2021-03-30 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
37 2021-03-31 pain in extremity Low grade fever (99-100 F) Sore L arm Fatigue
37 2021-04-01 flushing, tremor Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: the pt passed out 5 min after covid vaccine had possible seizure. ambulance was called at pt was given fluids by emts because of low pulse while sitting. pt was taken to er and his status unknown
37 2021-04-01 hot flush Full Body Aches and Chills. Headache. Dizziness. Fever. Nausea. Hot Flashes. Rash on arches of both ... Read more
Full Body Aches and Chills. Headache. Dizziness. Fever. Nausea. Hot Flashes. Rash on arches of both feet.
37 2021-04-01 numbness, tingling Vaccine details: "Pfizer-BioNTech COVID-19 Vaccine EUA" Numbness and constant tingling sensation i... Read more
Vaccine details: "Pfizer-BioNTech COVID-19 Vaccine EUA" Numbness and constant tingling sensation in left foot, left hand and fingers, and left side of face including mouth and tongue. Swollen feeling (no visible swelling) in face. Drooping sensation to left side of mouth. Numbness and tingling sensation only on side of body where vaccine was administered (left arm).
37 2021-04-01 tremor, speech disorder Generalized shaking, impaired speech, left hemiparesthesia
37 2021-04-02 seizure like phenomena Fear of needles, syncope. Seizure-like activity for 4 seconds. Alert. Patient states this has happen... Read more
Fear of needles, syncope. Seizure-like activity for 4 seconds. Alert. Patient states this has happened before.
37 2021-04-03 difficulty speaking Patient reported throat tightness, voice change, dizziness, SOB shortly after receiving vaccine.
37 2021-04-03 tingling Shingles The following Monday morning (6 days after vaccine) I started feeling pain and tingling in... Read more
Shingles The following Monday morning (6 days after vaccine) I started feeling pain and tingling in my back. Three days later I saw a rash and was treated for shingles. The rash is around the left side of my torso.
37 2021-04-04 tingling briefly blacked out loss of bladder tingly sensation to fingers feet and face.
37 2021-04-05 weakness Felt like a bad hangover that I couldn't get rid of. I had a 99 to 100 degree temperature. I had chi... Read more
Felt like a bad hangover that I couldn't get rid of. I had a 99 to 100 degree temperature. I had chills. I felt very very weak the whole day. I took the shot on Monday, felt horrible all of Tuesday, and on Wednesday I had a very slight headache, but felt much better than Tuesday. I drank a lot of water on Tuesday, but it seemed to help very little. A hot shower made me feel better on Wednesday night.
37 2021-04-05 seizure 3-31-21 6PM STATING PT PASSED OUT AND HAD A SEIZURE; HE WAS HOLDING HIS VACCINATION CARD IN HIS HAND... Read more
3-31-21 6PM STATING PT PASSED OUT AND HAD A SEIZURE; HE WAS HOLDING HIS VACCINATION CARD IN HIS HAND - REQUESTING PHONE NUMBER. CALLED FOR TRANSPORT TO ER. 4-6-21 10AM PT STATES HE HAS A HX OF BECOMING LIGHTHEADED FOR MANY YRS. HE WAS IN THE CHECK OUT LINE AND 'FELT LIGHTHEADED AND WAS GOING TO GET SOME CANDY TO FIX IT(HADN'T EATEN MUCH THAT DAY)'. BYSTANDER STATES HE PASSED OUT AND HAD A SEIZURE. HE DID FX RT SHOULDER. HAS AN APPT TO SEE PCP FOR F/U.
37 2021-04-06 bell's palsy Severe eye irritation, swollen face, bell's palsy, and hives.
37 2021-04-06 pain in extremity due to scheduling error for dose 2 patient received dose 7 days earlier than the recommended 21 day ... Read more
due to scheduling error for dose 2 patient received dose 7 days earlier than the recommended 21 day waiting period. patient experienced fatigue, arm pain and low grade fever.
37 2021-04-07 weakness, feeling hot, feeling cold Only symptom experienced during first ~36 hours after receiving vaccine was soreness near injection ... Read more
Only symptom experienced during first ~36 hours after receiving vaccine was soreness near injection area of left arm. A couple hours after falling as sleep the second night after vaccination shot (Sunday night), I woke up very cold / severe shivering. After several hours I managed to fall asleep for approximately another 1-2 hours. The next day I experienced fever, shivers, general body weakness/fatigue, and muscle aches/discomfort especially in both legs. These symptoms lasted throughout the day. That night (Monday night), when I got into bed, I was strongly shivering. I managed to fall asleep for 1-2 hours, but woke up uncomfortably warm. I was unable to fall back asleep until 4-5 hours later. I woke up 1-2 hours later, with most of my body dripping with sweat, and the sheets rather damp. Tuesday and Wednesday: Symptoms came and went, mostly feelings of fever, chills, general fatigue, lost appetite, and mild light headedness. Sleeping remained difficult, able to stay asleep for <4 hours each night. As of today (Thursday), fever has subsided. Still generally feel fatigued, occasionally lightheaded.
37 2021-04-07 cold sweat, muscle spasms Within minutes of receiving injection blood pressure dropped, lost consciousness, and experienced mu... Read more
Within minutes of receiving injection blood pressure dropped, lost consciousness, and experienced muscle spasms in left arm (injection site) which was witnessed by spouse. Woke moments later with nausea and cold sweat/chills. Tended to by EMTs and left facility after 45 minutes of observation.
37 2021-04-07 numbness Chest pain, numbness in left arm, and left leg. President headaches and fatigue for over two weeks a... Read more
Chest pain, numbness in left arm, and left leg. President headaches and fatigue for over two weeks after vaccine.
37 2021-04-08 burning sensation, facial paralysis, numbness Immediate numbness on left side of my body (arm, face); burning sensation in my face; face felt droo... Read more
Immediate numbness on left side of my body (arm, face); burning sensation in my face; face felt droopy; lightheaded; nauseous
37 2021-04-09 numbness, tingling, bell's palsy Bell's Palsy type Left Side Facial Numbness and Tingling Radiating to Left Arm, that Initiated 12-16... Read more
Bell's Palsy type Left Side Facial Numbness and Tingling Radiating to Left Arm, that Initiated 12-16 Minutes after the second injection lasting Approximately 24 Hours. Felt like I had been anesthetized for dental work, I was Given Oral Benadryl and observed for other Side affects. Numbness had resolved by the next afternoon.
37 2021-04-09 migraine with aura Potential TIA or migraine with aura; Potential TIA or migraine with aura; This is a spontaneous repo... Read more
Potential TIA or migraine with aura; Potential TIA or migraine with aura; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 23Mar2021 15:15, as single dose, for COVID-19 immunisation, at a pharmacy. There were no medical history and concomitant medications (no other medications received within 2 weeks of vaccination). The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient has no allergies to medications, food, or other products. On 25Mar2021 at 09:30, the patient experienced transient ischaemic attack (TIA) or migraine with aura which resulted to physician office and emergency room visits, and hospitalization for 1 day (unspecified date). The events were reported as life-threatening illnesses (immediate risk of death from the events). The patient did not receive treatment for the events. The patient recovered from the events on an unspecified date. Information on lot/batch number was available. Additional information has been requested.
37 2021-04-11 feeling hot All start around 5:00 am (caused early wake up) - Fever of 100.1 (broke about 5:00 PM) - Chills (sto... Read more
All start around 5:00 am (caused early wake up) - Fever of 100.1 (broke about 5:00 PM) - Chills (stopped about 3:00 PM) - Body aches (entire body, stopped about 7:30 PM) - Nausea (stopped about 2:00 PM) - Headache (stopped about 2:30 PM) - Body warm (started 10:00 PM stopped 9:00 am following day, 04/12)
37 2021-04-12 discomfort Body pain, malaise, discomfort
37 2021-04-12 tingling client complained of dizziness after receiving 1st Pfizer Covid Vaccine (lot#EW0161 Exp. 4/17/21). C... Read more
client complained of dizziness after receiving 1st Pfizer Covid Vaccine (lot#EW0161 Exp. 4/17/21). Client alerted EMT he was feeling dizzy, nauseous, and sweaty. Other medical staff joined EMT. Upon arrival client was sitting on chair, pale, diaphoretic, holding emesis bag. Alert and oriented. Client stated had been sitting approximately 13 mins when he started feeling tingling sensation to both arms below elbow, dizziness, nausea, and chills. Client denied chest pain, shortness of breath, headache or blurry vision. Vitals 1515: blood pressure: 132/90, pulse 60. Client transfered to gravity chair and given water. 1521 client stated tingling sensation was improving, chills were improving, and nausea had resolved. Medical history: sleep apnea. Medications: for gastritis, name not available, per client has not taken in a couple weeks. Vitals 1523: blood pressure: 130/84, pulse 68. Skin color improving, per client dizziness, chills, nausea all resolved. 1530 client stated tingling sensation had resolved. Medical staff slowly began to reposition client back to a straight chair position. Vitals 1532: blood pressure 132/85, pulse 60. No complaints, everything resolved. Client back in straight sitting position without complaints. Client advised to speak to provider prior to second dose. Last vitals at 1543: blood pressure 130/84, pulse 60. Per client feeling fine, ready to leave. Able to stand up with no dizziness. ER precautions given. Client left facility with steady gait at 1546
37 2021-04-12 tingling client complained of dizziness after receiving 1st Pfizer Covid Vaccine (lot#EW0161 Exp. 4/17/21). C... Read more
client complained of dizziness after receiving 1st Pfizer Covid Vaccine (lot#EW0161 Exp. 4/17/21). Client alerted EMT he was feeling dizzy, nauseous, and sweaty. PHN and PHN joined EMT. Upon arrival client was sitting on chair, pale, diaphoretic, holding emesis bag. Alert and oriented. Client stated had been sitting approximately 13 mins when he started feeling tingling sensation to both arms below elbow, dizziness, nausea, and chills. Client denied chest pain, shortness of breath, headache or blurry vision. Vitals 1515: blood pressure: 132/90, pulse 60. Client transfered to gravity chair and given water. 1521 client stated tingling sensation was improving, chills were improving, and nausea had resolved. Medical history: sleep apnea. Medications: for gastritis, name not available, per client has not taken in a couple weeks. Vitals 1523: blood pressure: 130/84, pulse 68. Skin color improving, per client dizziness, chills, nausea all resolved. 1530 client stated tingling sensation had resolved. PHN slowly began to reposition client back to a straight chair position. Vitals 1532: blood pressure 132/85, pulse 60. No complaints, everything resolved. Client back in straight sitting position without complaints. Client advised to speak to provider prior to second dose. Last vitals at 1543: blood pressure 130/84, pulse 60. Per client feeling fine, ready to leave. Able to stand up with no dizziness. ER precautions given. Client left facility with steady gait at 1546.
37 2021-04-12 tremor Low body temperature after physical exertion. Measured at 94.6 degrees when symptoms first appeared.... Read more
Low body temperature after physical exertion. Measured at 94.6 degrees when symptoms first appeared. Other symptoms include profusive sweating, joint pain, chills, fatigue, and tremors. Similar sensations as a fever. Increasing my body temperature via heaters, hot showers, and warm drinks temporarily alleviated these symptoms, but they returned with any moderate physical exertion. This lasted for 4 days.
37 2021-04-14 numbness, tingling, feeling cold 4/7 - Anxiety, sense of dread, tickling of spine 4/12 - Anxiety, sense of dread, ticking of spine, h... Read more
4/7 - Anxiety, sense of dread, tickling of spine 4/12 - Anxiety, sense of dread, ticking of spine, heavy eyes 4/13 - Anxiety, sense of dread, ticking of spine, coldness of hands/ feet, heavy eyes, itchy skin, mild sweating 4/15 - Tickling of spine, coldness of hands/ feet, numbness of hands/ feet, mild arthritis
37 2021-04-15 burning sensation Patient started to feel nauseas after vaccine. When asked if having other sxs patient unable to expr... Read more
Patient started to feel nauseas after vaccine. When asked if having other sxs patient unable to express. Vitals taken and provider came to assess patient. Patient complained of nausea and arm burning, but unable to answer questions well. Not able to tell us if mouth felt swollen. Due to patient unable to express sxs, provider had us call EMS, as could not tell if patient would or would not have anaphylaxis reaction. Patient brought to hospital/ER for further evaluation.
37 2021-04-15 seizure like phenomena While RN BSN CCM was conducting educational facts about the covid 19 vaccination. Observed patients ... Read more
While RN BSN CCM was conducting educational facts about the covid 19 vaccination. Observed patients body went stiff and fell backwards in sitting position in his chair and started to exhibit seizure like symptoms in his chair for approximately 8-10 seconds. RRT called immediately and arrived 1 minuted after. Pt had beads of sweat dripping off forehead. Temp obtain 86.6. Sp02 95% Attempted to obtain BP vitals but machine did not complete cycle before pt blacked out again. ED transferred at 1055.
37 2021-04-16 feeling cold Worst sickness/flu like symptoms I have ever experienced. Bad dehydration, diarrhea, throwing up, fa... Read more
Worst sickness/flu like symptoms I have ever experienced. Bad dehydration, diarrhea, throwing up, fatigue, light headed, chills, fainting/passing out. Had to diarrhea over 30 times in one day, throw up several times. Went to emergency room for treatment. IV treatment plus anti naseau and anti cramping Medication. Cramping was severe in upper intestine. Symptoms have decreased, but still linger after 2 weeks of 2nd shot. Concern if side effects are permeant. I still very tired/fatigued, have cramping, dirahaha, throwing up, aches muscles and joints- not feeling like myself and regret taking the vaccine if it results in lifelong side effects.
37 2021-04-16 seizure Systemic: Dizziness / Lightheadness-Mild, Systemic: Seizure-Mild, Additional Details: patient had a ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Seizure-Mild, Additional Details: patient had a history of seizure not related to vaccination.
37 2021-04-18 numbness, numbness 37-year-old male, with past medical history of Pre-Diabetes, Hypercholesterolemia, Thyroid nodules, ... Read more
37-year-old male, with past medical history of Pre-Diabetes, Hypercholesterolemia, Thyroid nodules, Kidney stones and Insomnia, who presents with left arm numbness post vaccination administration. Patient states that the numbness began at the vaccination site and traveled down to his left hand. Patient denies radiation of numbness to the left neck and/or face. This is the patients second vaccination that was received in the Left deltoid. Patient denies previous reaction to vaccination number 1 or to other vaccinations in the past. The NP and paramedics at patient side. Patient with equal strength and pulses to bilateral upper extremities. Stroke Scale negative. Patients initial vitals ( 145/99 BP, 98% RA, 99 HR, Resp 12, glucose 116), repeat vitals (134/84 BP, 100% RA, 81 HR) and (136/93 BP, 99%, 81 HR, Resp 10), (130/94 BP, 99% RA, 80 Pulse on discharge. EKG with NSR. Patient was monitored by the NP and Paramedic for 30 mins with resolution of symptoms. Patient denies numbness, weakness, tingling of the left upper extremity, chest pain, difficulty breathing or throat discomfort. Patient was cleared to be discharged home. Patient aware to follow up if symptoms persist or worsen.
37 2021-04-18 muscle spasms Severe chills and cramps, joint pain, cold sweating but no fever. My skin felt like it was on fire
37 2021-04-19 feeling hot, unresponsive to stimuli, numbness About 5 min after vaccination, the patient was leaning back in his chair with his eyes closed while ... Read more
About 5 min after vaccination, the patient was leaning back in his chair with his eyes closed while in the waiting room after his vaccination. I approached him and asked if he was alright and gently tapped his shoulder. He did not respond. I spoke louder, he did not respond. I shook his shoulder and spoke very loudly, he opened his eyes and rolled his head around and told me that he felt really dizzy. His skin was warm and he was sweating. He reported that he was breathing fine, that he just felt dizzy and hot. Over the next 5 minutes his dizziness decreased. He reported that the site of vaccination felt numb. Vaccination site did not show any redness or signs of local reaction. He reported that he was still breathing fine. His dizziness continued to decrease, and 25 minutes after the vaccine he reported that he did not feel dizzy anymore. He asked for some water, which I gave him. He stayed sitting in the chair until an hour after the vaccine. He got up and walked around and reported feeling no more dizziness and that he felt fine driving home.
37 2021-04-19 feeling of body temperature change, feeling hot Pt received in private observation room, laying on exam table with HOB at 45 degrees, HOB placed fla... Read more
Pt received in private observation room, laying on exam table with HOB at 45 degrees, HOB placed flat and legs elevated; pt in no distress, responds to all questions, alert, slightly diaphoretic and warm; VS at 1353: 107/59, HR 62 regular, RR 18, SaO2 98%; Pt states that he felt cold and hot and knew that a syncopal episode was starting as he was sitting in a chair so he immediately requested a soldier to put him somewhere to lay down; VS at 1405: 100/61, Hr 64, regular, RR 18, SaO2 100%, pt states that this is his usual BP reading; pt states that his last syncopal episode was approx 1 year ago; pt does not want an ice pack, states that he is feeling better; VS at 1420, 110/73, HR 66 regular, RR 18, SaO2 98%; pt states that he feels fine, HOB placed at 45 degrees, then 90 degrees and pt has no c/o, drinking water; VS at 1440 106/65, HR 56-66, regular, RR 16, SaO2 99%, pt ambulated in room and then in hall and has no c/o; states that he feels fine and plans to drive home; Pt left clinic at 1445, stable and no c/o.
37 2021-04-19 night sweats *Headache started on day 1 following vaccine and has persisted through day 9. Comes and goes varying... Read more
*Headache started on day 1 following vaccine and has persisted through day 9. Comes and goes varying in intensity, usually a dull ache at the front of my forehead. Gets worse later in the day and into the evening. * Body aches--started in the shot arm, then moved to shoulders and neck and sometimes lower back. Comes and goes with varying intensity. Has persisted through day 9. Sometimes it feels like achey area is emitting heat. * Night sweats- started around day 3 * Congestion/sinus pressure--intense sinus pressure (not a runny nose or cough) starting day 4 persisting through day 9. C Currently taking a steady dose of tylenol and sudafed. Have been taking tylenol since the shot on 4/11. GP admits she has no idea if this is related to the vaccine or another virus. I would love to get some clarity.
37 2021-04-19 pain in extremity Pfizer 1st dose 3/16/21 (lot # EL 9266) on LD??Pfizer 2nd dose 4/6/21 (lot # ER8729) on LD??On 4/9/2... Read more
Pfizer 1st dose 3/16/21 (lot # EL 9266) on LD??Pfizer 2nd dose 4/6/21 (lot # ER8729) on LD??On 4/9/21, a 37-year-old male, with a history of Alport syndrome with kidney transplant, presented to urgent care with some left anterior lower leg pains. About 6 months ago, he had a small, pea-sized mobile lump in the area, and it did not bother him. About 3 days ago, that little mass disappeared, and in its place, he had some pain, a slightly larger lump/swelling, and significant tenderness. He said the pain was severe when he put weight on his leg or puts pressure on the lump. It was suspected that he had a ganglion cyst that ruptured, and x-ray of the tibia/fibula was performed to evaluate for any bony abnormality. It was not sure if this is a vaccine related incident. Report for record keeping.
37 2021-04-20 cold sweat Body aches, headaches, fever, cold sweats, fatigue.
37 2021-04-20 numbness Numbness in face tht stopped after a hour. Continuous numbness in hand all on same side of body as t... Read more
Numbness in face tht stopped after a hour. Continuous numbness in hand all on same side of body as the shot was given
37 2021-04-20 tingling, discomfort Intermittent tingling(not full numbing) all over body(upper lip, left forearm, lower back, right sho... Read more
Intermittent tingling(not full numbing) all over body(upper lip, left forearm, lower back, right shoulder, left foot), overall feeling of heaviness, and slight lethargy.
37 2021-04-20 seizure Patient received vaccine in right deltoid. Approximately 90 seconds later he lost consciousness. Had... Read more
Patient received vaccine in right deltoid. Approximately 90 seconds later he lost consciousness. Had seizure like activity for approximately 30 seconds, then regained consciousness. BP checked and 130/90. HR initially irregular to auscultation then became steady. Strong pulse to palpation. EMS was called. Patient was given juice and crackers. Patient denies pruritis, difficulty swallowing, difficulty breathing, or facial swelling. Hx vasovagal response to vaccines in the past. No hx seizures. EMS arrived within 5 minutes and evaluated patient. Patient declined transportation to ER. He and partner waited in observation area for 30 minutes with no additional adverse effects.
37 2021-04-21 weakness Fever, Nausea, Loss of appetite. Joint Achs. Dizzy. Tired, Weak
37 2021-04-21 burning sensation One day after getting the second shot of the vaccine, my left eye lid started burning. then the next... Read more
One day after getting the second shot of the vaccine, my left eye lid started burning. then the next day i had a shingles outbreak in the area.
37 2021-04-21 hot flush Achy joints and muscles, fatigue, nausea, diarrhea, hot flashes, and headache.
37 2021-04-21 seizure I am patient's primary care provider. He reported to me yesterday, 4/21/21, that he received his fir... Read more
I am patient's primary care provider. He reported to me yesterday, 4/21/21, that he received his first dose of Pfizer on 4/9, and subsequently developed a fever and seized later that day.
37 2021-04-22 hot flush, pain in extremity Wave of lightheadedness, sweating, hot flashes that lasted less than 1 hour. Sore arm, not too sever... Read more
Wave of lightheadedness, sweating, hot flashes that lasted less than 1 hour. Sore arm, not too severe.
37 2021-04-22 seizure like phenomena The patient received 1st dose Pfizer while in his car at a drive-thru vaccine clinic. Within 90 sec... Read more
The patient received 1st dose Pfizer while in his car at a drive-thru vaccine clinic. Within 90 seconds of administration, the patient became dizzy, fell unconscious, and experienced 30 seconds of observed seizure-like activity. The patient has no history of seizures, however does have a history of 'vasovagal response' to needles. The patient regained consciousness after 30 seconds, EMS arrived and evaluated patient, and patient declined transport to an emergency room. He was observed for 30 minutes and discharged to home (driven by family member). BP taken during event = 130/90. No other symptoms reported.
37 2021-04-23 bell's palsy Developed Bell?s Palsy the next day.
37 2021-04-23 tremor High fever the night of the shot, shaking and chills. Puked a few times that same night. Felt very s... Read more
High fever the night of the shot, shaking and chills. Puked a few times that same night. Felt very sick, like a very bad flu. Next day had a low grade fever all day and evening, extreme lethargy, and muscle aches all over my body, especially my back. That night, 2nd after shot, I had profuse sweating in bed while trying to sleep. Had to wake up several times to change clothes and bed sheets as they were soaked in sweat. Feeling better today, still a little lethargic but no fever or sweats. It?s been a rough couple days.
37 2021-04-24 seizure like phenomena Faint, possible seizure (jerking on groud for a few seconds). BPs 89/47 (pulse 56), 130/77 (pulse 75... Read more
Faint, possible seizure (jerking on groud for a few seconds). BPs 89/47 (pulse 56), 130/77 (pulse 75). Hit head - recommended getting CT scan.
37 2021-04-24 unresponsive to stimuli, seizure Pt sitting in chair in observation area. Pt appeared to be unresponsive. Pt was lowered to the floor... Read more
Pt sitting in chair in observation area. Pt appeared to be unresponsive. Pt was lowered to the floor. Upon assessment it was found that the pt was having a seizure. Pt was then rolled onto his left side. Pt then came to consciousness. On site EMS picked pt up off floor and put him into w/c. VS at that time, BP: 178/92, O2 sat: 98% on RA, HR: 66, RR: 16. Pt is now alert and oriented and verbal. Pt declined further assessment and transport to hospital.
37 2021-04-25 pain in extremity left-sided enlarged axillary lymph nodes, had a subjective fever which was not measured, chills, bod... Read more
left-sided enlarged axillary lymph nodes, had a subjective fever which was not measured, chills, body aches, fatigue, left arm soreness, headaches, and some sharp chest pain x1 episode, started 20APR2021 warranting ED visit, mostly resolved other than fatigue and dyspnea on exertion by clinic visit 21APR2021
37 2021-04-25 tingling, numbness Numbness and tingling left side of face and neck. Difficulty swallowing.
37 2021-04-26 pain in extremity Fever (101.7), chills, severe diarrhea, headache, stomach pain, fatigue, loss of appetite, arm pain
37 2021-04-27 weakness Dizziness, disorientation, brain fog, headache, fatigue, weakness
37 2021-04-27 cold sweat Started with joint aches throughout whole body. Nausea, chills, uncontrollable shivering, high temp ... Read more
Started with joint aches throughout whole body. Nausea, chills, uncontrollable shivering, high temp at 99 on day 1, 102 on day 2, cold sweat. Joint ache, nausea continue on day 3, temp read 97 on day 3. Patient took OTC Acetaminophen 500 mg for pain relief.
37 2021-04-27 numbness The patient noted the weakness when he began walking down the stairs, and felt numbness that began f... Read more
The patient noted the weakness when he began walking down the stairs, and felt numbness that began from the level of his groin and continued downward. He also noted right upper extremity weakness as well. Following the patient's arrival to the ER, he reported that his left side felt numbness beginning, however not at the same level as it was on the right side.
37 2021-04-28 burning sensation Within 10 minutes developed headache, near syncope, blurred vision, Later that day chest pain, short... Read more
Within 10 minutes developed headache, near syncope, blurred vision, Later that day chest pain, shortness of breath improved over 3 days 2.5-3 weeks later peppery/burning sensation left side of body, left neck pain and headache Swelling left upper palate
37 2021-04-28 numbness Pfizer covid vaccine first dose given on 4/20/21 Tuesday. First sign/symptoms of right palm and fing... Read more
Pfizer covid vaccine first dose given on 4/20/21 Tuesday. First sign/symptoms of right palm and finger numbness noticed on Saturday 4/24/21. This numbness sensation continue through 4/24 to 4/26, while frequency increased and also noted becoming more severe and noticeable. On 4/27 to 4/28, noticed also right thigh and right buttock numbness occurred, and right hand (arm) numbness noticed on top of right finger/palms. On 4/28 and 4/29, noticed the numbness increased in severity. Noted a bit numbness or stiffness of neck, especially right side. A bit concern if it's adverse event from covid vaccine, and if this is temporary. Will continue monitor and self assess, may need contact local health facility or emergency room if continue worsen.
37 2021-04-28 migraine 12 hours after the dose began having violent shivering and a sudden spike in temperature to 103 degr... Read more
12 hours after the dose began having violent shivering and a sudden spike in temperature to 103 degrees F. Intense migraine behind eyes and pain down neck and shoulder with nausea. Fever continued to rise until taking Acetaminophen which lowered the temperature to average around 102. The fever lasted for an additional 36 hours. Temperature now fluctuates between 100 and 98 degrees The headache and nausea still continues 72 hours later. Fatigue has remained throughout.
37 2021-04-28 nerve pain, seizure, pain in extremity Fever, body aches, chills, involuntary violent full body convulsions that comes in waves, leg nerve... Read more
Fever, body aches, chills, involuntary violent full body convulsions that comes in waves, leg nerve pain, nausea, headache, muscle weakness: all symptoms began at 5 am waking me up from my sleep, currently still feeling symptoms 12 hours since symptoms began. Time of onset of symptoms was exactly 12 hours from vaccination injection. Important to note I have previously tested positive for covid in July of 2020.
37 2021-04-28 unresponsive to stimuli, seizure The patient was in the observation area with wife after being vaccinated. At 13:22 the patient fell ... Read more
The patient was in the observation area with wife after being vaccinated. At 13:22 the patient fell out of his chair, he became unresponsive and started having a seizure which lasted 2 minutes. The paramedics arrives at 13:23 and took his vitals. At 1325 the patient had another seizure which lasted 1 minute and 42 seconds. After the seizures he became responsive, but very lethargic. He was transported to the hospital at via ambulance at 13:26.
37 2021-04-29 pain in extremity, feeling cold, hot flush, tingling Day 1: left arm hurting, headache, dizzy, eyes hurting, tired Day 2: left arm hurting, tired, legs w... Read more
Day 1: left arm hurting, headache, dizzy, eyes hurting, tired Day 2: left arm hurting, tired, legs were weak, feeling not well in general Day 3 - day 7: left arm hurting, got a lump under my armpit (it hurts and bothers), I have a tingling sensation (left arm to my finges, my left chest, my left back), I feel like when you apply Bengay (hot and cold), it feels like this freeze sensation where heart goes, I feel like a pinch on my back. I get trouble breathing (like anxiety, but it's not). I feel my arm tingles like when you're on top of it and it's "asleep". I'm super scared because these are "known" effects, but it's been 7 days now. Also, I'm super scared because I've heard second dose is when you actually feel sick... if this is the first one, will it get worse on the second one? is it recommended to get second one?
37 2021-04-30 bell's palsy, facial paralysis Facial Paralysis/Bell?s palsy; Was given 60 mg oral steroids on site and 40mg prescription for 5 day... Read more
Facial Paralysis/Bell?s palsy; Was given 60 mg oral steroids on site and 40mg prescription for 5 days. Follow up in 3 days. Showing no improvements 8 hrs after first dose.
37 2021-04-30 numbness Wrist and hand went numb in the arm right after administration. He could move hand and all fingers a... Read more
Wrist and hand went numb in the arm right after administration. He could move hand and all fingers as normal and there was no pain, tingling or redness. He did wait about half hour and continued to move arm to see if any changes. Pt did have full range of motion just complained that hand was numb to the touch.
37 2021-05-01 weakness Soreness around injection site starting within a couple hours. Woke up at 9am the next morning with ... Read more
Soreness around injection site starting within a couple hours. Woke up at 9am the next morning with persistent feeling of drowsiness. Fever starting around 10:30am, peaking after a few hours at around 100-101 degrees. Full body achiness accompanying fever, with most extreme discomfort around the injection site. Symptoms responded well to Excedrin at regular intervals, although never completely went away that day. Woke up the second day feeling mostly better, although still very drowsy, fatigued, and weak for most of the day. Fever came back around 11pm, up to about 99.8 degrees, but after taking Excedrin it went away pretty quickly. Woke up feeling generally ok the third day following the vaccine, but started to get a low fever (98.8 degrees) around 2pm. Took Excedrin and feel much better.
37 2021-05-01 pain in extremity, flushing Shortly after the shot which was painless to take, I felt soreness in my arm and stiffness in my nec... Read more
Shortly after the shot which was painless to take, I felt soreness in my arm and stiffness in my neck and for about 1 min about 10 min after the shot my vision went slightly fuzzy and got slightly light headed but passed very quickly but I did feel flushed for about 30 min after. A few hours after though a fuzzy feeling over my head returned, my stomach was slightly nauseated, and had a slight fever. This did not really go away before I went to bed for the night. My shot was about 1:15 PM EST this was noticed about 4-5 pm starting and lasting until bed. Around 4:00 Am I woke and my stomach was very nauseated to feeling like I would puke but I was able to go back to sleep. When I woke my left arm felt very sore, my stomach the rest of the day until sometime the next morning around 6 am was unsettled. No issues using the restroom. But the fuzzy headache had persisted but by the end of the night I had a very front sided top of the head headache that radiated to my neck off and on. Swallowing water hurt, lights were becoming slightly painful. As well as my jaw ached a bit. I went to bed and throughout the night woke to a headache of the same nature but at time with a pulsing pain. Sometime around 6 am it did stop for the most part as well as my fever broke. When I got up for the morning and throughout the day now it being around 5:30 pm my stomach had stopped for the most part with the unsettled feeling, my headache for the most part disappeared but I still have this slight felling of something fuzzy laying on top of the front part of my brain. It not a feeling of being on top of the head but actually a feeling on the brain.
37 2021-05-01 pain in extremity 101 fever Very sore body Even more sore arm The first dose left me with sore arm that continued to b... Read more
101 fever Very sore body Even more sore arm The first dose left me with sore arm that continued to be sore off and on up until dose two. First dose didn?t give me any flu symptoms like the second one has. I could barely sleep through the night. 1st dose was 4/5/21 (Lot# EW0151) and second was 5/1/21 1st dose at and Second at
37 2021-05-03 weakness trouble walking; it was concluded that I had a stroke and the vaccine was likely the main contributo... Read more
trouble walking; it was concluded that I had a stroke and the vaccine was likely the main contributor.; the right side of my body was very weak and my balance was off.; the right side of my body was very weak and my balance was off.; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, administered on the left arm, at the age of 37 years, on Apr2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included brain tumor from an unknown date and unknown if ongoing. On 09Apr2021, the patient stated, "I am undergoing immunotherapy treatment for a brain tumor. My doctors recommended I take the vaccine 2 weeks following my most recent treatment (administered every 4 weeks). Several hours after receiving the vaccine, the right side of my body was very weak and my balance was off. These symptoms went away by the next morning. 5 days later they came back and progressed. Ultimately, I went to the emergency room having trouble walking, using my right arm and staying balanced. All tests (MRIs, ultrasound, CT scan, extensive bloodwork, and more) proved that there were no apparent causes. Ultimately, it was concluded that I had a stroke and the vaccine was likely the main contributor. I am 37, in shape, and eat extremely well." The patient was hospitalized for the events. The patient underwent lab tests and procedures which included blood test: there were no apparent causes, computerised tomogram: there were no apparent causes, magnetic resonance imaging: there were no apparent causes, sars-cov-2 test: negative on 15Apr2021 and ultrasound scan: there were no apparent causes on an unspecified date. Therapeutic measures (Aspirin prescription, Castor, physical therapy) were taken as a result of the events. The outcome of the events was recovering. Information about Batch/Lot number has been requested.
37 2021-05-03 cold sweat High fever, headache, extreme shivers, sweats, shortness of breath, clammy skin.
37 2021-05-03 pain in extremity, nerve pain Woke up 4/5/21 with neck pain. Then nerve pain moved to bottom of neck down to shoulder and to scapu... Read more
Woke up 4/5/21 with neck pain. Then nerve pain moved to bottom of neck down to shoulder and to scapula. Pain will radiate down to elbow. Then loss of use of arm began. Unable to lift shoulder into shoulder flexion.
37 2021-05-04 bell's palsy 3 days after receiving the Pfizer SARS-CoV-2 vaccine, pt developed Bell's Palsy on the left side of ... Read more
3 days after receiving the Pfizer SARS-CoV-2 vaccine, pt developed Bell's Palsy on the left side of his face. This has not remitted despite standard treatment (prednisone and valacyclovir).
37 2021-05-04 flushing, weakness Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: OXYGEN WAS 98, TEMP WAS 99.1, BP WAS 111/65
37 2021-05-04 pain in extremity Watering eyes/recurrent eyes watery; Runny nose/recurrent runny nose; Drop in blood pressure; Season... Read more
Watering eyes/recurrent eyes watery; Runny nose/recurrent runny nose; Drop in blood pressure; Seasonal allergy; Postural orthostatic tachycardia syndrome; tachycardia syndrome; Psoriasis flare-up/flare off of psoriasis/Psoriasis flare-up/Psoriasis flare-up -Worsened; Scalp swelling/ scalp swelling - Worsened/swollen scalp; Knee swelling; Psoriatic arthritis aggravated/-Worsened/flare off of psoriatic arthritis; Itchy scalp/Itchy scalp -Worsened/Localised itching -Worsened/itch on back, arms, knees; Local swelling / Local swelling -Worsened/swollen back; Scalp pain/Scalp pain Worsened/painful scalp; Pain back/Pain back - worsened/painful back; Painful arm/Painful arm - worsened; Painful knee/Painful knee Worsened; Swollen arm /Swollen arm -worsened; This is a non-interventional study report based on the information received by Pfizer (Mfr Control No. 21K-163-3740568-00) received from a contactable consumer (patient). A 37 yearsold male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 25Mar2021 (at the age of 37 years old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2017 (Batch/Lot number was not reported) to 25Mar2021, at unknown dose weekly[1 in 2 wk] for Moderate to Severe Chronic Plaque Psoriasis . Medical history included non tobacco, abstains from alcohol, Klippel feil syndrome, spinal fusion surgery, seasonal allergy, postural orthostatic tachycardia syndrome from 2017 to an unknown date , blood pressure decreased from 2017 to an unknown date. The patient concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced psoriatic arthritis aggravated/-worsened/ flare off of psoriatic arthritis (medically significant) on 25Mar2021, postural orthostatic tachycardia syndrome on an unspecified date, tachycardia syndrome on an unspecified date. psoriasis flare up/ Psoriasis flare up -Worsened on 25Mar2021, scalp swelling/ scalp swelling - worsened/ painful scalp on 25Mar2021, knee swelling on 25Mar2021, watering eyes/recurrent eyes watery on an unspecified date, runny nose/recurrent runny nose on an unspecified date, drop in blood pressure on an unspecified date, seasonal allergy on an unspecified date, itchy scalp/itchy scalp -worsened/localised itching -worsened/ itch on back, arms, knees on 25Mar2021, local swelling / local swelling -worsened/ swollen back on 25Mar2021, scalp pain/scalp pain worsened/painful scalp on 25Mar2021, pain back/pain back - worsened/ painful back 25Mar2021, painful arm/painful arm - worsened on 25Mar2021,painful knee/painful knee worsened on 25Mar2021, swollen arm /swollen arm -worsened on 25Mar2021, psoriasis flare-up/psoriasis flare-up -worsened on 25Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop on 2017 blood test: normal o an unspecified date, magnetic resonance imaging: normal on 2018, x-ray: normal on 2008. The action taken in response to the event for adalimumab was permanently withdrawn on 25Mar2021(also reported as dose not changed). The clinical outcome of the event Psoriatic arthritis aggravated, Psoriasis flare-up, Scalp swelling, Knee swelling, Itchy scalp, Local swelling , Scalp pain, Painful arm, Knee pain, Swollen arm, Psoriasis flare-up was not recovered, while Postural orthostatic tachycardia syndrome, tachycardia syndrome, Watering eyes, Runny nose, Drop in blood pressure recovered, and the remaining events was unknown. Causality for Humira (Adalimumab) the reporter's causality for the event(s) of postural orthostatic tachycardia syndrome, swollen scalp, swollen knee, recurrent eyes watery, recurrent runny nose, blood pressure drop, seasonal allergies, itch on scalp, itch on back, arms, knees, swollen back, flare off of psoriasis, flare off of psoriatic arthritis, painful scalp, painful back, painful arms, painful knees, swollen arm and recurrent congestion with humira (adalimumab) was no reasonable possibility. The reporter assessment of the causal relationship of the (enter the event term) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, the reported events are attributed to underlying or intercurrent medical conditions which were unlikely related to BNT162B2 vaccine.
37 2021-05-06 migraine 1st shot in left arm-I had a red bump that was 3x3 inches and raised. It eventually went away after ... Read more
1st shot in left arm-I had a red bump that was 3x3 inches and raised. It eventually went away after two weeks leaving behind a bruise. 2nd shot- right arm,by day two I was feeling flu like symptoms. By day three I was short of breath,dehydrated,experiencing rapid heart rate,fever,chills,shortness of breath,sweating,dizziness,migraines which last a week. The bad headaches continued for a month and my blood pressure went from normal to high. I had to go on blood pressure medication after having my vaccine. I still don't feel the same since being vaccinated. I feel fatigued all the time,I have edema, and suffer with chronic headaches.
37 2021-05-06 migraine Severe migraine lasting 7 days.
37 2021-05-06 pain in extremity Cellulitis in the arm i received the shot; pain in my arm where i received the shot; This is a spont... Read more
Cellulitis in the arm i received the shot; pain in my arm where i received the shot; This is a spontaneous report from a contactable other hcp. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: EL1284), dose 1, via an unspecified route of administration on 30Dec2020 (at the age of 37-years-old) as a single dose for covid-19 immunisation. Medical history included was reported as none and the patient reported no known allergies. There were no concomitant 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 vaccination. No other medications were received within 2 weeks of the vaccination. On 15Jan2021, the patient reported he started having pain in his arm where he received the shot. He went to the doctor and was diagnosed with cellulitis in the arm he received the shot. Therapeutic measures taken included unspecified antibiotics. Clinical outcome of the events cellulitis and pain in the arm he received the shot was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; 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 cellulitis and pain in arm due to temporal relationship. There is limited information provided in this report. 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 2021-05-06 pain in extremity patient was sweating profusely, stated he was very dizzy and his heart felt funny. Provided patient... Read more
patient was sweating profusely, stated he was very dizzy and his heart felt funny. Provided patient with a cold, wet paper towel, checked blood pressure at 11:10 was 127/86 and pulse was 91. Provided patient with cold water to drink. Re checked blood pressure at 11:40 am 111/77 and pulse was 74. Patient stayed for almost one hour before he felt well enough to drive. I called the patient to check on him at 1:05 pm and he stated he was feeling ok but his arm was sore. I recommended he apply ice to the sore arm.
37 2021-05-06 tingling dizzy, heart racing, chest pressure, lower extremity pins and needles, EMS evaluated, pt. refused EM... Read more
dizzy, heart racing, chest pressure, lower extremity pins and needles, EMS evaluated, pt. refused EMS transport.
37 2021-05-07 burning sensation, tenderness Received first dose of vaccine on 4/30/21. The next day on 5/1 noted itching and a burning sensation... Read more
Received first dose of vaccine on 4/30/21. The next day on 5/1 noted itching and a burning sensation to the right side of his face in the nasal and orbital area. 2 days later a rash appeared to the right sided nasal and orbital area of face, that has gradually spread down the cheek and up the forehead. Painful and sensitive to touch.
37 2021-05-07 seizure My prescribed medication therapeautic levels were stable. After receiving Pfizer BioN Tech vaccinati... Read more
My prescribed medication therapeautic levels were stable. After receiving Pfizer BioN Tech vaccination on April 17, 2021, it triggered me a seizure (convulsion) on April 28, 2021. Why is Pfizer vaccination causing convulsions?
37 2021-05-07 tremor Vaccine Adverse Event Report May 8th, 2021. Patient, had an appointment for his 2nd dose of Pfizer ... Read more
Vaccine Adverse Event Report May 8th, 2021. Patient, had an appointment for his 2nd dose of Pfizer Covid 19 vaccine May 8th 2021 at 10:00am. His first dose of Pfizer Covid 19 was at our Pharmacy on April 16th, 2021. At around 10:15am, patient came in with his fiancé, who is a doctor at pediatric department, shown on her name tag. After processing the paperwork needed for vaccination, Pharmacist on duty, went over the VAR to ensure the provided information was adequate before it was ready for my intern to administer the shot. Patient looked fine as I was able to have a brief conversation with him while waiting for the shot. Due to some insurance issues that needed to be resolved, at 10:40am, pharmacy intern, took the patient to Patient Health Room for immunization. At 10:45am, I was ringing up a prescription at Terminal 42 when hearing the word, Help, coming from the Patient Health Room. Within seconds later, the door was opened as I was running out the pharmacy toward the Patient Health Room to see what happened. The patient was lying on the floor, unconscious, while his fiancé was calling his name asking whether he was okay and rolled him to his side and supported his head. I reached into the cabinet and prepared to administer an EPIPEN to the patient, meanwhile, pharmacy technicians, asked and dialed 911. As his fiancé kept calling his name, the patient gained consciousness. I asked intern what had happened to clarify whether it was a reaction due to the vaccination or not. Meanwhile, the patient's fiancé stated this event was not unexpected. Patient was able to talk and confirmed he was fine. Unfortunately, it appeared that the patient bruised his nose and forehead with slight blood from a minor cut. We instructed the patient and his fiancé to stay in the room and offered assistance upon request until EMS arrived. Patient's fiancé requested an ice pack for his bruise. Later on, the patient appeared to be shaking, so I asked the fiancé whether it was okay to give him some GATORADE. His fiancé also requested a glucose meter to check his blood sugar. The EMS arrived within minutes and patient was transported to hospital Before they were leaving, I asked the fiancé if there was anything she would like us to do as well as offered a follow-up. She declined the offer. I also asked briefly if she could share his medical condition, but the fiancé only disclosed that the patient has needle anxiety. The EMS also said that they will take it from here, and there is no additional action needed from our end at this time. Each team members who were involved in the event wrote reports and kept them filed in the pharmacy records.
37 2021-05-09 feeling cold passed out 4 hours after i received shot and did not remember even thinking about going to sleep. I ... Read more
passed out 4 hours after i received shot and did not remember even thinking about going to sleep. I woke up and was sweating, cold, headache, body aches, dizzy, feeling ok, then feeling terrible going thru the cycle again and again. The above scenario has been going on since around 12pm the last day I received the shot.
37 2021-05-09 feeling hot Clogged ears (patient has no history of/never experienced this before), "warm" sensation up and down... Read more
Clogged ears (patient has no history of/never experienced this before), "warm" sensation up and down both sides of neck. Ongoing after 6 days, though perceived lessening with time. Fatigue and mild headache, lasted for 3 days.
37 2021-05-09 flushing Pt experienced syncope w/ flushing/sweating, light headed and dizziness. VSS. Pt given water and i... Read more
Pt experienced syncope w/ flushing/sweating, light headed and dizziness. VSS. Pt given water and indicated that he is feeling better. Pt stable and released from vaccination site.
37 2021-05-09 migraine Within 8hrs of vaccination, extreme chills, joint aches, dizzyness migraine headache, and fever last... Read more
Within 8hrs of vaccination, extreme chills, joint aches, dizzyness migraine headache, and fever lasting throughout the night into early morning of 5/09/2021, fever lasted into evening of 05/09/2021. As of 05/10/2021 still have periodic migraine headaches and dizzy spells.
37 2021-05-09 pain in extremity onset w/in 2 hours of bil arm pain, primarily in the Left arm. Sx have persisted 2 weeks
37 2021-05-09 seizure like phenomena Seizure like activity without any personal or family history. All vitals and tests were normal when ... Read more
Seizure like activity without any personal or family history. All vitals and tests were normal when taken by EMT and RN at the hospital.
37 2021-05-09 tremor Strong full body shakes for several hours accompanied by a mild headache.
37 2021-05-09 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Detai... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt was seated after the vaccine in observation area. He stood up saying he had to use the bathroom. He proceeded to faint and was caught. He passed out and then came around seconds later. BP check and pulse were normal. Had him lie down with legs raised. Gave water and cookie. He stayed about 45 min. He was driven home later. Called his home at end of day and said he was sleeping but fine.
37 2021-05-10 feeling hot, tremor he felt like he was on something, like someone sedated him and like he was under the influence like ... Read more
he felt like he was on something, like someone sedated him and like he was under the influence like as if someone put something in his drink; chills on his body, shaking all of a sudden; chills on his body, shaking all of a sudden; blacked out, had lost consciousness; started with flu like symptoms; headache; dizzy; stomach pain; feeling very hot; he had an accident while driving fully loaded vehicles; This is a spontaneous report from two contactable consumers (one is patient mother). A 37 years old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0170) injected in left arm on 20Apr2021 14:00 at age of 37 years old at single dose for COVID-19 immunization. Medical history was not reported. There were no prior vaccinations within 4 weeks. No AE(s) following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. Concomitant medications were not reported. Patient previously took the first dose of BNT162B2 (lot number: EN6207) administered in left arm on 20Mar2021 at 14:30 (24hrs) at age of 37 years old at single dose for COVID-19 immunization and experienced soreness, arm pain. Caller states patient (her son) had his second Covid vaccination on 20Apr2021, the first one was 20Mar2021. Caller states patient had really a severe reaction from the second Covid Vaccination and that was the reason they are calling to find out. Caller states they reported it to the health department and the location where he had the vaccination but they had no success at all with that. Caller states she will just give an overview and then maybe the patient can chime in if there is any specifics, then maybe he can answer those. Caller states so her understanding was that several hours from having the vaccination, he blacked out, had loss of consciousness on 20Apr2021. Caller states it happened while he was driving on the highway. Caller states it resulted in an accident. Caller states the patient is a self-employed, owner/operator with a transporter that he drives for, he transports automobiles. Caller states what happened was he blacked out while talking on the phone to her other son and that was how they were aware that he had an accident while driving fully loaded vehicles, in his occupation. Caller states she called 911. Caller states of course they did not have direct information for 911 in the area that she was calling from, but they were able to locate someone, she did not even know the definite of where he was located and by that time, someone had arrived to the accident scene. Caller states the EMS and police department arrived on the scene and the EMS person said that it was a common thing for someone after having the Covid vaccination to black out and have a loss of consciousness. Caller states they checked the patient out and said that they did not have any reason to take him to the emergency because there were more COVID patients in the hospital there and that was the extent of what she knows. Patient states he blacked out on 20Apr2021 around approximately 20:30, 21:00 (24 hrs). Caller states he took the vaccine at 14:00 (24hrs) on the same day. Caller and patient states that is the first episode he has ever experienced, he has never had any blackouts before, no loss of consciousness. Patient states first off, he started with flu like symptoms, in which he had a headache on 20Apr2021, and was real dizzy on 20Apr2021. Patient states then the blacking out came into place. Patient states it also came with stomach pain before and dizziness on 20Apr2021. Patient states he was feeling very hot on 20Apr2021 then all of a sudden that was pretty much when he lost consciousness when he was operating a vehicle. Caller verifies the accident and the symptoms are from the second vaccine. Patient verifies had the accident around 2030 or 2100 and felt many of those symptoms right before. There was no adverse events (AEs) require a visit to Emergency Room or Physician Office. Reporter for AEs seriousness was unspecified. Caller states he received the first Covid vaccine 20Mar2021 at 14:30(24hrs) and the second Covid vaccine 20Apr2021 at 14:00 (24hrs). Patient verifies that all the symptoms happened at one time. Caller states the patient had no symptoms prior to the vaccination on 20Apr2021 other than the small symptoms, he did have some symptoms from the first vaccination. With the first dose, caller states just soreness, arm pain, not like symptoms from the second vaccine. Caller states with those symptoms and everything, he was driving and he was trying to get to the nearest place where he could pull over and he did not remember how close he was. Patient states he was probably about 40 yards from the location that he needed to be at to pull off the roadway. Patient states the next day or the next evening, for the whole day on 21Apr2021, he felt like he was on something, like someone sedated him and like he was under the influence like as if someone put something in his drink. Patient states he had chills on his body, he was shaking all of a sudden, then a day later, he felt like a whole new person. Patient states it took about two days for it to get out of his system and then he states he has recovered completely from all symptoms by 22Apr2021. Caller asking if there was another number or something that she can contact regarding the results of having the reaction and causes of these symptoms. Caller states when she had a Pfizer vaccination she got some flyers and that was really where she got the information at to call because nobody really knew. Caller states she contacted a lot of numbers prior to getting this number and nobody really knows so she had a flyer on counter measures and the compensation program and she was wondering what the phone number was for that program since an accident occurred that resulted after the vaccine. Outcome of event had an accident while driving fully loaded vehicles was unknown, for rest events was recovered on 22Apr2021. Additional information has been requested.
37 2021-05-10 migraine persistent severe headaches/severe migraine like headaches; photophobia/sensitivity to light; body a... Read more
persistent severe headaches/severe migraine like headaches; photophobia/sensitivity to light; body aches; fatigue; This is a spontaneous report from a contactable Physician reported for a male patient. A 37-year-old male patient received first dose of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 12Apr2021, as single dose for covid-19 immunisation. Medical history and concomitant medications were not provided. On an unspecified date in 2021, patient started to experience severe migraine like headaches/ persistent severe headaches accompanied with sensitivity to light/ photophobia, body aches and fatigue. The reporter (physician) has tested the patient for multiple issues including COVID-19 and done blood work and all came back negative. The patient has had an MRI which was also negative for any abnormalities. Patient was treated with Aleve, Advil, and steroids but none of which resolved headaches. The patient was still suffering with headaches and photophobia and described them as intermittent with pain ranging from a 2 to a 9 on the pain scale. The patient was evaluated by a neurologist who stated that headaches could be associated side effects from the vaccine and has prescribed medications for migraines to aid in symptom management. The Physician was concerned due to the length of time his patient has been experiencing these symptoms since it was outside of the normal range of time for systemic type symptoms to resolve. He stated that patient was another wise very healthy with no other issues. Outcome for the events persistent severe headaches/severe migraine like headaches and photophobia/sensitivity to light was not recovered and for body aches and fatigue was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
37 2021-05-10 muscle twitching After injection I had muscle twitching in my left arm. I had some wheezing about 2 hours after injec... Read more
After injection I had muscle twitching in my left arm. I had some wheezing about 2 hours after injection. I still have pain in shoulder on 5/11/21 (injection performed 4/21/21)
37 2021-05-11 weakness, cold sweat, feeling hot, tingling, inability to speak Client received the COVID vaccine (Pfizer, lot # EW0182, expiration date 5/13/2021) at 1455. The cl... Read more
Client received the COVID vaccine (Pfizer, lot # EW0182, expiration date 5/13/2021) at 1455. The client complained of feeling hot, nausea, spotty vision at. EMT and RN responded at this time. The client was offered a bottle of water. He appeared pale and clammy, and was speaking in 1-2 word sentences. The client denied chest pain or shortness of breath. At 1506, the client stated that he was feeling "weak and faint" and was transferred to the zero gravity reclining chair at that time. The client denied any medical history, stated he takes no medications, and has no allergies. The client stated he ate breakfast at 1000 and hadn't had anything to eat or drink since then. At 1509, the client's vital signs were as follows: blood pressure 100/60, heart rate 52, respiratory rate 20, O2 97%, temperature 96.3 (the client was still quite sweaty at the time.) The client's pulse was thready but regular. The client continued to appear diaphoretic but his color was improved. He was alert and oriented. The client stated his arms were tingling but his vision had returned to normal and his nausea had resolved. The client refused benadryl at this time. At 1517, the client's heart rate was 84, respiratory rate 14, pulse strong and regular. The client's skin color had returned to normal and he was no longer diaphoretic. The client stated that his symptoms had all resolved and he was feeling "back to normal." Education provided regarding v-safe, primary care follow up, symptom management, AMR activation and emergency management. At 1530, the client's vital signs were as follows: blood pressure 100/82, heart rate 72, pulse strong and regular, O2 96%. The client was able to stand up from the reclining chair without any dizziness, and ambulated with a steady gait to his car, where he drove himself home.
37 2021-05-11 bell's palsy Bells palsy; This is a spontaneous report from a contactable consumer (patient) reported for himself... Read more
Bells palsy; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, at the age of 37 years, on 24Apr2021 09:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced bells palsy on 24Apr2021 16:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Apr2021. Therapeutic measures (Steroids and anti viral) were taken as a result of bells palsy. The outcome of the event was not recovered. Information about batch/lot number has been requested.
37 2021-05-12 involuntary muscle movements, seizure like phenomena Recipient received pfizer vaccine at 12:22. Vaccinator reports recipient had no voiced concerns or s... Read more
Recipient received pfizer vaccine at 12:22. Vaccinator reports recipient had no voiced concerns or s/s of anxiety at time of vaccination. Recipient talkative in exit area with no outward signs of distress. Sitting in chair when he lost consciousness at 12:28. Guided to floor by this reporter and and 1 additional clinician. As recipient was guided to floor rigidity was noted and he started to experience seizure like activity, jerking movements, foaming at the mouth. He was turned on his side and material placed under head. Jerking movements lasted for 45 seconds after which time the patient continued to have eyes closed, breathing sonorous, unlabored, small amount of blood on lips.
37 2021-05-12 tremor Pt c/o lightheaded while sitting in 15 min waiting area. 2nd mask removed & taken to Observation ar... Read more
Pt c/o lightheaded while sitting in 15 min waiting area. 2nd mask removed & taken to Observation area per w/c. Vomited x2, shaky, pale & diaphoretic. BP125/87 R16 Legs elevated on cot & rested. 4:20 PM Sitting up & eating juice & crackers. Color improved 4:42 Released after walking around & stating he feels better. BP 125/87 R 16
37 2021-05-14 migraine migraines; dizziness off and on; Severe chronic headaches; fatigue; little lethargic/feeling letharg... Read more
migraines; dizziness off and on; Severe chronic headaches; fatigue; little lethargic/feeling lethargic; sensitivity to light; balance is off/was going left and right trying to stay in balance; hypersomnia; not been able to work or drive since being vaccinated; vision impairment; This is a spontaneous report from contactable other HCP. A 37-years-old (current age of 37-38 when the reported events began) male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EW0I58; expiration: not reported), intramuscular, administered in arm right on 12Apr2021 16:00 as single for Covid-19 immunisation/covid precautions, not wanting to get covid at pharmacy or drug store. The patient medical history was none. Concomitant medication(s) included vortioxetine hydrobromide (TRINTELLIX; received within 2 weeks of vaccination). No additional vaccines administered on same date of the Pfizer suspect, no other prior vaccinations (within 4 weeks prior to the COVID vaccine), no relevant family medical history. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. No other products and no investigation assessment. On 13Apr2021, the patient had headache, sensitivity to light, was feeling lethargic, balance was off, fatigue, and hypersomnia. The headache and vision impairment (start date: 13Apr2021) were ongoing and began the very next day after the 1st dose of the Pfizer COVID Vaccine and at first the headache was very severe and now was just different and his headache kind of moved around and was always constant and persistent and got better and then boom it came back. The patient had been a little lethargic (start date: 13Apr2021) and that began the same day as the headache and vision impairment which was the very next day after the 1st dose of the vaccine. Dizziness (start date: 13Apr2021) began the very next day after the vaccine and was almost like an imbalance of whenever he was walking, he noticed he was kind of not walking a straight line almost and was going left and right trying to stay in balance (start date: 13Apr2021) and this was a little bit better. After the 1st dose the patient was getting a little concerned right now because he got the vaccine about three weeks ago and ever since he had been having severe chronic headaches and vision impairment that was ongoing and began the very next day after the 1st dose of the vaccine; the patient was a little lethargic, kind of had dizziness off and on and went to his PCP, had an MRI, and was sent to a neurologist. The patient was taking Advil, Motrin and Tylenol that were not helping his migraines (start date: unspecified) and nothing from the bunch of medications the neurologist gave him were working to help and stated Nurtec ODT (lot 3990840, expiry date Oct2022 and NDC 72618-3001-1) 75mg once daily and Nortriptyline 10mg (orange pharmacy bottle with no lot, expiry date or NDC) supposed to be one capsule the 1st week and then two capsules after that by mouth. Motrin, Advil and Tylenol (no lot numbers, expiry dates or UPC numbers to provide because he ran out of those and threw the bottles away when he was done and has been meaning to get more but has not). Unspecified medicines, Toradol IV were given as therapeutic measure. The patient was not sure about the dates regarding his MRI (MRI was maybe a week and a half after this all started and then maybe a week after that he saw the neurologist). Headaches kept him up to night also and the patient had been to neurology, ophthalmology consultation, and received an MRI. The adverse events resulted in disability or permanent. The patient had not been able to work or drive since being vaccinated. The patient had no further treatment and had not gone to the ER but was under advisement that he was to go to the ER, but he could not afford to go to the ER. The patient had not had the 2nd dose of the Pfizer COVID Vaccine yet and his PCP and neurologist both agree that he would not be getting the 2nd dose of the vaccine due to the reactions he has had. The patient was calling to see if Pfizer offered help as he was without insurance and his PCP said he might need to send the patient to the hospital which might be out of the question and he was calling to see if Pfizer could help him with anything as he has not been at work for three weeks and the headache was not going away. The patient underwent lab tests and procedures which included magnetic resonance imaging with no results on unspecified date and nasal swab (sars-cov-2 test) was negative on 15Apr2021. The outcome for little lethargic/feeling lethargic was not recovered, severe chronic headaches was not recovered, sensitivity to light was not recovered, balance is off was not recovered, fatigue was not recovered, hypersomnia was not recovered, not been able to work or drive since being vaccinated was not recovered, vision impairment was not recovered, kind of has dizziness off and on was recovering and for migraine was not recovered. Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: The events was considered related to suspect drug based on Compatable temporal association and known safety profile of the drug. 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.
37 2021-05-17 weakness 37 year old male arrived to observation area. Pt. stated feeling nauseated, weakness. Observed to ... Read more
37 year old male arrived to observation area. Pt. stated feeling nauseated, weakness. Observed to be sweating. Two episodes of emitus with clear fluid vomitus. Denies any other pain. Fire Rescue arrived at scene. Vital signs rendered. Pt. declined hospitalization at this time. Patient recovered from adverse reaction. PO fluids given as tolerated. Pt denied any pain or discomfort. Pt. left observation area at 12:05pm.
37 2021-05-17 muscle spasms, numbness, discomfort After the first shot I began to feel a pressure in my neck. A few days after the second shot, I was ... Read more
After the first shot I began to feel a pressure in my neck. A few days after the second shot, I was walking across a street and my neck began to choke and my jaw locked up for about 10 seconds. It released a bit but was still very uncomfortable. I sought immediate medical help and was given steroids. The medical professional on staff said it was from the vaccine, but that I would be fine. I am now three weeks out from my second vaccine and my neck (rt side) is still stuck in spasm, and there is a growing numbness with a few painful spots growing up the right side of my face up to my eye. My Dad is an ophthalmologist, and he examined me. Confirmed the spasms in my neck and diagnosed the cheek numbness as infra-orbital neuralgia. He said he "strongly believes it is from the vaccine". I went back to the original facility the next day (5/17/21) and am now being referred to an ENT.
37 2021-05-19 muscle spasms (1) Wed, May 12th - I woke up around 7:30am with pain in my right side near the rib cage/beneath my ... Read more
(1) Wed, May 12th - I woke up around 7:30am with pain in my right side near the rib cage/beneath my chest. The pain was also in my upper right shoulder and trap/neck area. (2) Sat, May 15th - in the evening time around 7:30pm I was riding passener seat in a car and started having shortness of breath (constricted breathing) and immense pain in my right side near my rib cage/beneath my chest. The pain felt like the worst muscle spasm I've ever encountered. The pain was gripping and persistent. It was hard to breathe and even harder to utter out a word or two. This intense pain last for 45 minutes until I got home. I admitted myself into the ER around 8:30pm. Around 7 hours later and after a series of multiple tests I was told I have PE-blood clot in my lungs. (3) Sun, May 16th - I was admitted in the hospital around 5:30am. (4) Tue, May 17th - I was discharged around 4:30pm
37 2021-05-19 pain in extremity Extreme Debilitating Dizziness for 4 days so far as well as fatigue. Muscle pain that comes and goes... Read more
Extreme Debilitating Dizziness for 4 days so far as well as fatigue. Muscle pain that comes and goes in left arm, neck , upper back and both legs. Wheezing on days 1-3.
37 2021-05-20 flushing, feeling hot Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: per patient he felt little dizzy about 5 minutes after vaccine while sitting. after about 10 minutes total he passed out (for about 5 seconds)while sitting in chair and fell on to ground and appeared to hit his head. he did wake up, was aleart and responsive while 911 was on their way. 911 did come to store they did assess him and he did walk himself out. he felt ok when he left. he did feel very hot and sweaty when he woke up
37 2021-05-20 unresponsive to stimuli pt received second dose of pfizer vaccine and within ten minutes started feeling dizzy and nauseated... Read more
pt received second dose of pfizer vaccine and within ten minutes started feeling dizzy and nauseated, sweating and feeling as though having a panic attack. Pt had syncope episode and ammonia inhalant used and pt non responsive. 911 called and pt monitored. Once pt placed on stretcher pt became more responsive and was able to state name and todays date, bp 109/62 p73 @ 15:48 / bp 109/74 p 88 @ 15:52. Pt verbal and states he is feeling better, states he has not had much to drink today and has been mowing today. EMS on scene and pt leaves clinic with EMS.
37 2021-05-21 numbness, sensory loss, tingling Received shot on 5/17/2021 at 1:00...Within 20 to 30 minutes upon receiving the Pfizer COVID-19 vacc... Read more
Received shot on 5/17/2021 at 1:00...Within 20 to 30 minutes upon receiving the Pfizer COVID-19 vaccine, I experienced numbness on the right side of my entire body where the vaccine was given, also and pressure behind my right eye. Along with tingling on the right side of my body, headache, fatigue. Called pharmacy and was advised by a man that it?s fairly common and that it would go away in 24-48 hours and if it didn?t then to seek medical care. As of 12:40AM on 05/22/2021 it is better but still not back to fully 100%. It is now been 4 days going on 5 and I still have loss of sensation on the right side of my body of approximately 5% (tingling). Have not taken anything nor sought medical care. Even thought a visit to the ER was recommended, Patient said he could still mostly function.
37 2021-05-21 tingling Systemic: Tingling (specify: facial area, extemities)-Mild
37 2021-05-23 facial paralysis My right ear hurt two days later so two more days passed and the right side of my face began to para... Read more
My right ear hurt two days later so two more days passed and the right side of my face began to paralyze and the next day it no longer responded until today. I have right side of my face paralyzed I have spent too much money on doctors and meds and I have no favorable response from my face.
37 2021-05-23 numbness arm numbness, light headed, izziness
37 2021-05-23 numbness Patient complained of numbness during observation after receiving the second dose of the Pfizer vacc... Read more
Patient complained of numbness during observation after receiving the second dose of the Pfizer vaccine. EMS was called and treated the person on scene.
37 2021-05-23 unresponsive to stimuli Within two minutes from getting his second shot, Pt passed out from a standing position striking th... Read more
Within two minutes from getting his second shot, Pt passed out from a standing position striking the back of his head. Pt was unresponsive for 2 minutes before he was able to talk to EMS, Pt was picked up by staff and with his head supported placed on the stretcher to be take to the medical for treatment. While in treatment room, vitals and demographics were obtained. Treatment included ongoing vitals, ice pack for his head (large contusion to the right back of his head approx. 50 mm in dia. After 20 minutes of treatment and assessment, Pt tried to sit up and upon doing so became very dizzy and light headed. At this time the decision to call for a transport ambulance was made by calling 911. ambulance arrived within 10 minutes verbal report make to the medic and care was turned over at that time.
37 2021-05-24 burning sensation, numbness Pt yelled loudly upon cleaning of area for vaccine before needle went in; then after complained of b... Read more
Pt yelled loudly upon cleaning of area for vaccine before needle went in; then after complained of burning, big lump in throat, heaving but no vomit, anxiety, was laid on ground (911 called) and given epinephrine injection then complained of right side chest pai n, numbness in both hands, extreme anxiety. wanted to refuse paramedic treatment but eventually went to hospital. Pt called later to thank staff and said was feeling better but continuing right side pain after having been given benadryl and steroid in hospital.
37 2021-05-24 feeling hot headache, feeling faint and hot. given water and rest
37 2021-05-24 numbness, tingling Timeline just provided to neurologist. 5/1 - 2nd COVID vaccine (Pfizer) 5/3 - Went to Urgent Care ... Read more
Timeline just provided to neurologist. 5/1 - 2nd COVID vaccine (Pfizer) 5/3 - Went to Urgent Care for primarily chest pains 5/5 - GP sent to ER after continued severe chest pains and getting very winded after only a few steps. Weekend of 5/8 - vomiting, likely fever (felt like true vaccine side effects) - no vomiting/fever since Since then, lots of tests/dr visits. Current symptoms: tingliness/numbness - left leg - midshin to foot/toes. Left arm - elbow to hand/fingers. Face started to tingle ~2 weeks post vaccine - left side. Extremely fatigued. Some brain fog/forgetfullness. Lack of motivation. Irritability some days. Headaches - some days really bad, other days none. Chest pains come/go throughout day. Was getting winded walking up 3 stairs but that has been slightly better. Some days - extensive muscle pain. Especially in lower back & left hip area. Some days - whole body aches. Chills - feels like body temp is off. Things come in waves - numbness/tingliness is pretty much all the time though. Also, insomnia. Did start to take 1.25mg of melatonin as needed but still very fatigued. 5/19 - Stared acupuncture (plan is 2x a week) Around 5/21 - developed rash. Face (R&L side), neck/jaw area (L), inner thigh (L). Doesn't itch all the time but when it does, it really itches. Has continued 5/22 & 5/23 - headaches worsened 5/22 & 5/23 - developed diarrhea 5/23 - more tingliness developed midshin to right foot and more in right arm. 5/25 - joints began to hurt more - especially in elbow area Lung dr. Rx'ed albuterol (?) on Friday, 5/21 just in case something was going on in lungs. Has not helped. The lung dr. noted weakness in right leg during physical exam. Lung dr. and cardiologist discussed possibility of Guillain Barre Syndrome. Another blood test was ordered to check for some receptors. Awaiting results. Neurologist appt scheduled for 5/ 28
37 2021-05-24 muscle spasms, feeling cold After leaving site (while driving), my tongue became very heavy and almost difficult to swallow. Aft... Read more
After leaving site (while driving), my tongue became very heavy and almost difficult to swallow. After approximately 20 minutes, it passed. At the same time my right arm (opposite the injection arm) began to have muscle spasms which too passed. A wave of cold spread throughout my body and immediately my anxiety began to skyrocket (untriggered). None of these symptoms occurred after 1st dose. Insomnia the night of both the 1st and 2nd doses. Nearly 2.5 weeks after 2nd dose, dizziness is a daily occurrence followed by symptoms of vertigo (at times wakes me up at night). Fatigue has intensified.
37 2021-05-27 muscle twitching Twitching between facial left cheek and upper lip. Started after 30 days of 2nd dose. Its been 2nd d... Read more
Twitching between facial left cheek and upper lip. Started after 30 days of 2nd dose. Its been 2nd day and twitching hasn't stopped.
37 2021-05-27 nerve pain patient got itchy rash and nerve pain
37 2021-05-27 tingling, numbness, sensory loss I had the vaccine and later that night I lost sensation in the tip of my right index finger about h... Read more
I had the vaccine and later that night I lost sensation in the tip of my right index finger about half a centimeter of my finger. I could not feel anything there. I could only feel extreme tingling the next day and ultra sensitive of pinching needles. And a couple of days later it became numb. And for my second dose I notified the medical personal about my adverse event and they did a medical test with a paper clip and I could feel that.
37 2021-05-28 flushing Systemic: Allergic: Anaphylaxis-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadn... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: He had blurred vision, sweating a lot and dizzeness
37 2021-05-28 muscle twitching About 2 days after the 2nd dose random muscles will be twitching all over my body. I was saw a Nuero... Read more
About 2 days after the 2nd dose random muscles will be twitching all over my body. I was saw a Nuerologist and he diagnosed with Benign Safciculation Syndrome.
37 2021-05-28 tremor, tingling After receiving 2nd vaccine shot in early AM, felt great throughout the day. Around 9:30pm, I start... Read more
After receiving 2nd vaccine shot in early AM, felt great throughout the day. Around 9:30pm, I started experiencing shivers that turned into the worst shivers that I've ever experienced throughout my entire body. I could barely function, hands/arms/feet/fingers were shaking - even my jaw was uncontrollable clacking up and down. At the peak, this transpired into an intense headache in the upper back part of my head that scared me to death, it was severely intense to the point I thought I was having a stroke or something. My head pounded all night and also my body felt like needles were poking me in every joint in my entire body. Sleeping was miserable and minimal and symptoms are continuing the next day but not as severe. Lots of body pains and a constant headache. Resting and drinking water to try and remedy.
37 2021-05-31 bell's palsy Possibly/suspected bell's pulsy; inability to make full smile on the right side; Numbness in on righ... Read more
Possibly/suspected bell's pulsy; inability to make full smile on the right side; Numbness in on right side of tongue; loss of grip strength in right hand; unable to fully close right eye; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: zho179), the first dose via unspecified route of administration in left arm on 08May2021 at 13:00 as single dose for COVID-19 immunisation. The relevant medical history was not reported. Concomitant medications were reported as none. On 11May2021, the patient experienced numbness in on right side of tongue, inability to make full smile on the right side, loss of grip strength in right hand. No other symptoms presented. Possibly/suspected bell's pulsy unable to fully close right eye. No treatment received for the events. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the events was not recovered.
37 2021-06-01 cold sweat, feeling cold, involuntary muscle movements Patient received his first Pfizer vaccine and during monitoring period he became cool, clammy and pa... Read more
Patient received his first Pfizer vaccine and during monitoring period he became cool, clammy and pale. HR 50's; BP 110/74; O2 Sats 90%. He proceeded to pass out 3 times with jerky movements noted. EMS notified. Patient stated he had not eaten and had drank very little. EMS arrived and evaluated patient. He declined going in for further evaluation or treatment. Continued to monitor with no further episodes.
37 2021-06-01 facial pain, trigeminal neuralgia 3 Days following my second shot, I felt a horrible shock/pain through my neck and jaw that made me c... Read more
3 Days following my second shot, I felt a horrible shock/pain through my neck and jaw that made me crouch down in pain in the middle of a busy street. I went straight to an urgent care. The provider said it was a vaccine side effect and gave me steroids to take for four days. The next week, I went back because I began to feel a pulling sensation/pain develop on the side of my face. They referred me to an ENT. I went to the ENT. He found a vocal chord nodule and ordered a CT scan. Before I could make the CT scan appointment, I had an episode in the shower where I began to see flashing lights and my limbs became wobbly and weak. I was very dizzy and had to hug the shower wall for support. My wife took me to the emergency room where a multitude of tests were run including a CT scan. Nothing was remarkable, but the doctor was concerned about the neurological effects, and referred me to a neurologist. I saw the neurologist the next day, and she diagnosed me with trigeminal neuralgia on top of ordering an MRI of my brain (normal). I am taking carbamazepine and baclofen as treatment for the condition. She said it can occur virally.
37 2021-06-01 migraine headache; had a little migraine; This is a spontaneous report from a contactable consumer or other n... Read more
headache; had a little migraine; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EW0IS) via an unspecified route of administration, administered in left arm on 08Apr2021 as single dose for COVID -19 immunisation. The patient medical history and concomitant medications were not reported. On 08Apr2021 the patient experienced headache, had a little migraine. Caller stated he had the first dose of the Pfizer COVID vaccine today and had a little migraine; stated he did not eat a lot today and had a headache that occurred after the vaccine; caller stated he was calling to see if he could take Aspirin BC powder or Tylenol or something and known once he taken something like Tylenol, he will feel better. Caller aware that we could not provide treatment recommendations or medical advice and was referred to his HCP. Caller stated he did not think the headache had to do with the vaccine, but he did not eat and did not know but the headache just up and started. HCP information: Caller declined HCP information and stated he did not have HCP. Caller stated he had the Pfizer COVID Vaccine about 10:25 am and the headache began after that. Stated the headache was not like it was earlier and he got something to eat so he was 80 percent feeling a little better. Caller stated he had not required treatment for the reported event at this time. No follow-up attempts are possible; information about lot/batch number cannot be obtained. The outcome of all events was recovering. Communication: Caller stated the lot number for the Pfizer COVID vaccine was handwritten on his patient card and he thought it was EW0IS; captured as stated by the caller; stated his card did not have the NDC or expiry date written on it. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
37 2021-06-03 pain in extremity First shot: right arm pain; This is a spontaneous report from a contactable consumer or other non hc... Read more
First shot: right arm pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EW0173), via an unspecified route of administration, administered in arm right on 30Apr2021 (at the age of 37-years-old), at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. After first shot, the patient developed right arm pain on an unspecified date in 2021. Outcome of the event was resolved on an unspecified date in 2021. Information on the lot/batch number has been requested. Follow up needed, further information has been requested.
37 2021-06-05 night sweats I received my second dose of the Pfizer / BioNTech COVID-19 vaccine on Tuesday, May 18, 2021 at 1:53... Read more
I received my second dose of the Pfizer / BioNTech COVID-19 vaccine on Tuesday, May 18, 2021 at 1:53pm EDT. Many of the "typical" or "expected" side effects commenced about 12 hours later, including chills, night sweats, a slight fever (99.5), and headache and lethargy the following day. Nothing was particularly off-putting until the afternoon of Wednesday, May 19, 2021, when I noticed small red spots on my legs and feet. A Google search suggested petechiae and enough cause for me to go to a nearby urgent care clinic. The petechiae were present on both legs and feet (and eventually a few spots on my hands), though a little more pronounced on the left side (with one noteworthy cluster on my left leg). I had no apparent gum bleeding or bruising (maybe one bruise, but the urgent care doctor thought it was there beforehand). The doctor at the urgent care clinic confirmed petechiae and ran stat blood work for return that night. At ~9pm EDT on Wednesday, May 19, 2021, I received a phone call from the urgent care's centralized lab informing me that my platelet count was 2 (10^3/uL) -- dangerously low, with risk of spontaneous bleeding and in the worst case scenario brain hemorrhage -- and my PTT was 55.6 seconds. They told me to report to an emergency room immediately, the nearest of Medical Center. The diagnosis was eventually Immune Thrombocytopenia (ITP). Every physician I've encountered has felt that the occurrence one-day post-vaccination points to the vaccine as the cause. (For what it's worth, I do not think any of the doctors or nurses I encountered had never seen a platelet count so low. Most of them said as much.) My discharge papers officially note as the diagnoses: petechiae, thrombocytopenia, and adverse effect of vaccine. I have included details related to my platelet count, treatment course, and other figures below (and am happy to provide corroborating information where appropriate). The doctors did not run any d-dimers, PF4 HIT ELISA, or fibrinogen tests, and no imaging was performed, presumably because I did not present with any signs of simultaneous clotting (e.g., TTP or VITT). They've also told me that my haptoglobin and hemoglobin levels were normal (see below), which I am told helps support the notion that there was / is no clotting or "red blood cell breakdown." Search terms: decreased platelet count, immune thrombocytopenia, ITP, severely low platelet count, low platelets, petechiae, idiopathic thrombocytopenic purpura, immune thrombocytopenic purpura, vaccine-induced immune thrombocytopenia, vaccine-induced ITP
37 2021-06-06 tremor, weakness Woke up around 1:30am with extreme chills, shakes, tremors, teeth chattering, and could not stay sti... Read more
Woke up around 1:30am with extreme chills, shakes, tremors, teeth chattering, and could not stay still in bed. Took Tylenol in the evening and took another dose at 2am. It was about 78 degrees in our house that evening, and I had a comforter and another blanket on in bed. The chills subsided by 7am, but then my body felt like it got hit by a truck and was hard to move or get out of bed. I had to stay home and attempt to work from home, although the body weakness and headache lasted until 8pm on 4/28. Overall, it felt like flu condensed into a 24 hour period.
37 2021-06-07 pain in extremity, muscle spasms, muscle twitching Muscle contractions, twitching, spasms: with pain in the right leg, buttock, calf, difficult to get ... Read more
Muscle contractions, twitching, spasms: with pain in the right leg, buttock, calf, difficult to get in a car and drive, cannot sit in chair for less than 15 seconds, after the second vaccine.; Muscle contractions, twitching, spasms: with pain in the right leg, buttock, calf, difficult to get in a car and drive, cannot sit in chair for less than 15 seconds, after the second vaccine.; Muscle contractions, twitching, spasms: with pain in the right leg, buttock, calf, difficult to get in a car and drive, cannot sit in chair for less than 15 seconds, after the second vaccine.; Muscle contractions, twitching, spasms: with pain in the right leg, buttock, calf, difficult to get in a car and drive, cannot sit in chair for less than 15 seconds, after the second vaccine.; Muscle contractions, twitching, spasms: with pain in the right leg, buttock, calf, difficult to get in a car and drive, cannot sit in chair for less than 15 seconds, after the second vaccine.; This is a spontaneous report from a contactable consumer (patient's mother). A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration, to his right arm on 24May2021 around 10 AM (Lot number: EW0185, NDC number/Expiry date: Unknown) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 to his right arm on 03May2021 in the morning (Lot number: EW0165, NDC number/Expiry date: Unknown) as single dose for Covid-19 immunization. On 26May2021, the patient experienced muscle contractions, twitching, spasms: with pain in the right leg, buttock, calf, difficult to get in a car and drive, cannot sit in chair for less than 15 seconds, after the second vaccine. Caller confirmed that her son had his second shot of the Pfizer vaccine, reclarified as the Covid vaccine. Caller stated that last Tuesday until now, her son had been having muscle contractions from his legs to his buttocks, and the back of his foot, had to be messaged. Muscle contractions and pain from his leg to his buttock, and the back of his foot: later reclarified as muscle contractions, muscle twitching, and muscle spasms of the right leg and buttock, and calf. Caller stated when her son woke up in the morning, he had pain with the muscle contractions. Caller stated that her son did not have any health insurance, at that time. Some patient details reclarified later in the call, by the caller's son when reported on himself. Caller's son stated that it was hard for him to get in a car or sit in a chair, for less than 15 seconds. Caller's son stated that he could not drive. Reclarified, patient stated that his muscle contractions, spasms also feels like they were twitching. Caller notified that Pfizer was unable to provide medical advice but might have resources to help answer some questions. In this situation, the caller was encouraged to go to an Urgent Care, should his symptoms become concerning. Additional information had been requested. Reporter seriousness for muscle contractions, twitching, spasms: with pain in the right leg, buttock, calf, difficult to get in a car and drive, cannot sit in chair for less than 15 seconds, after the second vaccine: Unspecified. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
37 2021-06-07 tremor Mother reporting. He got his vaccine, and did fine yesterday. He woke up his mother at 5:40, came ... Read more
Mother reporting. He got his vaccine, and did fine yesterday. He woke up his mother at 5:40, came to his mothers room and said that he was shaking, and mother noticed that he was, trembling. She asked what was wrong and he said that he could not stop shaking and his chest was hurting. She set him down in a chair and she got the autometer to check his BP and oxygen, and his BP was 134/98, and his 02 was 96, heart rate 86. She felt him to see if he was having a fever, it was 98.4. She told him to sit for a little while and waited about 10 minutes, she checked his BP again at 6:00 AM, and it was 139/102, he said that he was feeling really dizzy, his head started hurting real bad. He said that he had a bad taste in his mouth. She just monitored him, and his 02 was still 96, heart rate was still good. He stayed in her room until 6:15 and she got up and told him if he got worse she would take him to the ER. At 6:25 she gave him two 500 mg of Tylenol tablets and sat him in a recliner. At 7:30 his head was still hurting, but he was not shaking, and she gave him some yogurt and water. He stated that he started feeling better and around 7:40 he went back up to his room and went back to sleep. He has been ok since then.
37 2021-06-08 migraine I received my first Pfizer Covid shot on Feb 2, 2021 with no adverse reaction. I received my second ... Read more
I received my first Pfizer Covid shot on Feb 2, 2021 with no adverse reaction. I received my second shot on Feb 23, 2021 and had a headache/ minor migraine two days later. By the next day I was alright. On approximately May 4, 2021 (I can't recall the exact date) I briefly experienced light pain in my chest while using an under-desk elliptical at work. I am in good shape and that has never happened before. I last had an ECG in October 2020 during a physical for my job, and there were no issues at the time. The pain lasted four about a half hour and then subsided. Exactly one week later on the afternoon of May 11, I experienced the pain again at work while sitting at my desk, but that time for approximately ten minutes. I have not experienced any further pain and never saw a doctor concerning the pain.
37 2021-06-08 pain in extremity Immediately felt pain moving from injection up and down arm into shoulder and neck and down into han... Read more
Immediately felt pain moving from injection up and down arm into shoulder and neck and down into hand. Within 5 minutes my back and neck muscles felt tight like knots and painful. Fatigue onset within 30 minutes. Headache onset at 1 hour. Felt soreness in joints (elbow, fingers, toes, knees) within 1 hour. Symptoms have not subsided since injection. Felt very sleepy but have been restless and rolling around without full sleep. Still very sore and fatigued.
37 2021-06-08 tingling Severe tingling ,mostly upper and lower extremities which has not improved after 6 weeks now. Upper ... Read more
Severe tingling ,mostly upper and lower extremities which has not improved after 6 weeks now. Upper extremities weakness, weak grip (right hand) which is better now.
37 2021-06-09 flushing flush feeling; chest pain to L lower chest; Vaccine-Related Anxiety (include misc mental health); SO... Read more
flush feeling; chest pain to L lower chest; Vaccine-Related Anxiety (include misc mental health); SOB; NVD; Visual/Neuro concerns; Visual/Neuro concerns; This is a spontaneous report received from a non-contactable Other HCP. A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205 and Expiration date was not reported) via an unspecified route of administration, on an unknown date (at the age of 37 years), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported.On an unknown date, during his 15 minutes waiting period after the injection, the patient began to experience flush feeling with chest pain to L lower chest. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light headedness, dizziness, facial swelling, lip swelling and tongue swelling. Differential Diagnosis was reported as Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Monitored for approx. 15 minutes. Pt greatly improved. CP resolved within 1 minute of being in the bay after drinking. VS stable/improved. Pt ambulated out of the medical bay w/o assistance. Recommended protein based food and hydration 30 minutes prior to next vaccination. Follow up with pcp as needed. Pt voiced understanding and is appreciative of today's evaluation. Treatment included: water and snacks. Outcome of the events was reported as unknown. No follow up attempts are possible. No further information is expected.
37 2021-06-13 myelitis transverse, numbness TM developed left sided facial numbness that progressed to 1st left arm, then right. Symptoms have ... Read more
TM developed left sided facial numbness that progressed to 1st left arm, then right. Symptoms have progressed to include both legs and feet.
37 2021-06-13 numbness and pain in extremities Intermittent peripheral neuropathy developed within a few minutes of received the first shot and mos... Read more
Intermittent peripheral neuropathy developed within a few minutes of received the first shot and mostly resolved after about two days but has not fully resolved in the back after approximately 3.5 weeks
37 2021-06-20 numbness numbness in left arm and hang, weakness in left hand
37 2021-06-21 numbness Client reports that the following morning after getting his COVID 19 Pfizer vaccoine that we woke up... Read more
Client reports that the following morning after getting his COVID 19 Pfizer vaccoine that we woke up with facial numbness above the nose and that is lasted 2 days, but Tylenol assisted with it.
37 2021-06-21 numbness Patient's brother works as a medical assistant and his brother, the patient, experienced numbness on... Read more
Patient's brother works as a medical assistant and his brother, the patient, experienced numbness on his whole arm as opposed to the area around the shot when he went for his 2nd Pfizer dose at clinic on June 14th around 3:15pm. They are looking at possible nerve damage to the arm. According to the patient's brother, the person administering the vaccine went in at an angle that is not 90 degrees and therefore did not administer the vaccine correctly and caused injury to the person they vaccinated.
37 2021-06-23 flushing, weakness, tingling, numbness Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypertensio... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: 911 was called...emt personnel checked him out and monitored him...pt refused transport to hospital and recovered within the half hour. numbness and tingling was reported by pt in his injection arm within 5 minutes of injection. this effect bothered pt and I believe this may have led to the vagal nerve reaction he apparently suffered.
37 2021-06-25 weakness Chills, weak, sinus pressure, extremely painful earache
37 2021-06-27 pain in extremity 1st dose - 05/22 11:30 AM - Pain in arm, mild feverish, tiredness and mild chest pain. 2 nd dose - ... Read more
1st dose - 05/22 11:30 AM - Pain in arm, mild feverish, tiredness and mild chest pain. 2 nd dose - 06/12 10:30 AM - Pain in arm, tiredness more pulling pain in chest
37 2021-06-29 muscle spasms I was sitting watching tv in my chair, drinking soda, 4 hours after shot when I started getting naus... Read more
I was sitting watching tv in my chair, drinking soda, 4 hours after shot when I started getting nauseous and I had to go vomit. I ended up passing out. I came out of it within a minute later and my heart was racing like crazy. I sat there, drinking cold water, and I stayed up because I was nervous to go to bed. The next day I felt fine, but I did have the usual side effects-muscle spasms and headache. A week later my chest got very tight and I started getting pain in my chest and I thought it was the muscle spasms. The next Sunday on 06/20/ 2021 I went to the urgent care because I woke up and didn't feel right. They did EKG, chest x-ray and they took blood and they got me into a cardiologist. I went to him on the 06/22/2021 and they did another EKG and it was normal and he told me that I could keep exercising (works out 5x a week). Last Friday my chest tightness was so bad when I left the gym so I went to the ER and they did another EKG and blood work and they did a cat scan and everything was normal - also an x-ray. He thinks it's inflammation of the chest wall surrounding the heart but he did not tell me it was a side effect of vaccine. I've never had tightness in chest or issues with heart. It was really scary and I'm wearing a heart monitor and just returned it today. I do have a few more appointments coming up with my PCP and cardiology. I've been taking Advil 2-3 times a day, and I think it might be anxiety a little bit and it's messing with my head.
37 2021-06-30 pain in extremity Sore arm; Headache; Fatigue; This is spontaneous report from non-contactable consumer, the patient. ... Read more
Sore arm; Headache; Fatigue; This is spontaneous report from non-contactable consumer, the patient. A 37-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8430) via an unspecified route of administration on left arm on 23Mar2021 at 08:15 as a single dose (at the age of 37-year-old) for COVID-19 immunisation. Medical history was not reported. The patient had allergy to penicillin and avocado. The patient did not receive any concomitant medication. 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 23Mar2021 at 20:30, the patient experienced sore arm, headache and fatigue. The patient did not receive any treatment for the 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 events sore arm, headache and fatigue were not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
37 2021-07-02 numbness, numbness and pain in extremities Four days following first dose, sudden numbness developed followed by weakness in right leg. Initial... Read more
Four days following first dose, sudden numbness developed followed by weakness in right leg. Initially attributed to peroneal neuropathy and did not seek medical help. Second dose was received and left foot numbness developed followed by weakness. Symptoms ascended to knees the next few days and was admitted to the hospital. MRI's, x-rays, blood work, lumbar puncture were performed. Treated with 4 days of IVIG. EMG performed to diagnose with Guillain-Barre Syndrome.
37 2021-07-02 pain in extremity In the left arm pit area, where he put deodorant, was painful; He felt pain in his left chest muscle... Read more
In the left arm pit area, where he put deodorant, was painful; He felt pain in his left chest muscle; His left chest felt swollen when he touched it; He had a little pain in his left arm on Saturday, between 2:00PM-3:00PM; This is a spontaneous report from a contactable consumer. A 37-year male consumer (patient) received Bnt162b2 (BNT162B2; Formulation: Solution for injection), dose 2 via unknown route of administration, administered in arm left on 01May2021 as SINGLE DOSE for COVID-19 immunization, and Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot Number: ER8733) dose 1 Intramuscularly, administered in arm left on 03Apr2021 as SINGLE DOSE for COVID-19 immunization. Patient was 37 years old age at time of vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. No emergency room, and physician office visit required. . It was reported that he received his second COVID-19 Vaccine on Saturday, 01May2021, and was still having pain in his (left) arm and (left) chest (muscle). He said his employer told him after 3 days, he had to get a notification from his doctor for why he was sick. He said the clinic he went to said the could not give him the notification his employer was looking for because their clinic didnt provide the COVID-19 Vaccine. He said he had to go back to work tomorrow, and he was not ready to go back to work tomorrow. Caller asked if there was anyway Pfizer could give him a letter to give to his employer for the pain he had in his (left) arm and (left) chest (muscle). Caller was advised that Pfizer was the manufacturer of the COVID-19 Vaccine and did not provide medical advice or services. The caller was offered transferred to Pfizer Medical Information for further assistance. Reporter Type: Stated he worked for Company as a delivery guy, and put together beds. Reported he had a little pain in his left arm on Saturday, between 14:00PM-15:00PM. He said he fell asleep, and woke up on Sunday (02May2021), and his chest felt swollen. He clarified he felt pain in his left chest muscle, and that the pain was all in the left chest muscle and his left armpit. He said he didnt have any pain on the inside, but he could tell the left chest muscle felt swollen when he touched it. He said he really did not have any pain in his left arm anymore, but in the left arm pit area, where he put deodorant, was painful. He said after a couple days his left chest muscle and left armpit were getting better, but he was not ready to go back to work and put hospital beds together. He said on Saturday morning (01May2021) he exercised and did not know if that had anything to do with the pain he was experiencing. Reported he does not have a doctor at this time. Adverse Event (AE) Details: Reported he received his second COVID-19 Vaccine on Saturday, 01May2021, and was still having pain in his left arm, and left chest muscle. He said he had a little pain in his left arm on Saturday, between 14:00PM-15:00PM. He said he fell asleep, and woke up on Sunday (02May2021), and his left chest felt swollen. He said he felt pain in his left chest muscle, and that the pain was all in the left chest muscle and his left armpit. He said he didnt have any pain on the inside, but he could tell the left chest muscle felt swollen when he touched it. He said he really didnt have any pain in his left arm, but in the left arm pit area, where he put deodorant was painful. He said after a couple days his left chest muscle and left armpit were getting better, No follow-up attempts are needed. No further information is expected.
37 2021-07-11 tingling Pins and needles, tingling in left foot
37 2021-07-17 nerve pain, feeling hot, burning sensation, feeling cold wandering nerve pain/Basically nerve sensations throughout the body, intermittent nerve sensations, ... Read more
wandering nerve pain/Basically nerve sensations throughout the body, intermittent nerve sensations, nerve pain; shooting pains in the arms, legs and trunk; nerve hot cold sensations those kind of thing throughout the body intermittently; nerve hot cold sensations those kind of thing throughout the body intermittently; burning; This is a spontaneous report from a contactable other Health Care Professional (patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 29Jan2021 (at the age of 37 years old) as a DOSE 2, SINGLE for covid-19 immunisation. Medical history included , hypertension 9 Blood pressure high) from an unknown date and unknown if ongoing. Concomitant medication(s) included amlodipine besilate (NORVASC) and amlodipine (AMLODIPINE, 5mg Daily) both were taken for an unspecified indication, start and stop date were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 8Jan2021 (at the age of 37 years old) as a DOSE 1, SINGLE for covid-19 immunisation. On 01Feb2021, the patient experienced wandering nerve pain/basically nerve sensations throughout the body, intermittent nerve sensations, nerve pain, shooting pains in the arms, legs and trunk, nerve hot cold sensations those kind of thing throughout the body intermittently and burning. Patient reported that, two to three days after second dose he developed wandering nerve pain, burning, shooting pains in the arms, legs and trunk. These effects had been intermittent but is still experiencing them. Patient reported that, It would be some neuralgia. Basically, nerve sensations throughout the body, intermittent nerve sensations, nerve pain, nerve hot cold sensations those kind of thing throughout the body intermittently, Not mouth specifically. You know in the leg, the feet, the arms, the hands, around the body. All over the body really. Consumer stated that, "I am not sure if this line is for medical providers only. I am an individual who received the Pfizer Covid vaccine and having some peculiar side effects that I wanted to report to the company." Consumer further added, he received First dos on 08Jan and second on 29Jan. start date for the event was 01Feb." Consumer stated, "I think the simplest way to put it would be some neuralgia. Basically, nerve sensations throughout the body, intermittent nerve sensations, nerve pain, nerve hot cold sensations those kind of thing throughout the body intermittently." Consumer stated, "Objectively he did believe that the time of the symptoms in relation to second dose of the vaccine, that they are related." Consumer asked, "Well, is there any way that he can find out if other people are having these kinds of symptoms. he could not find anything online." Outcome of the wandering nerve pain/basically nerve sensations throughout the body, intermittent nerve sensations, nerve pain, nerve hot cold sensations those kind of thing throughout the body intermittently and burning was unknown and shooting pains in the arms, legs and trunk was not recovered. Follow-up (12May2021): Follow-up attempts completed. No further information expected.
37 2021-07-17 tingling, cold extremities Sight tingling in both arms; Feels like arms are cold; This is a spontaneous report from a contactab... Read more
Sight tingling in both arms; Feels like arms are cold; This is a spontaneous report from a contactable consumer reported for himself. A 37-year-old male patient received BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot number: EN6199), via an unspecified route on 05Mar2021 (age at 37-year-old male), as a single dose for covid-19 immunization. Medical history included hypertension. The patient concomitant medications were not reported. No known allergies were reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021, patient experienced sight tingling in both arms. Feels like arms are cold. Patient did not receive any treatment for the events. The clinical outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
37 2021-07-17 speech disorder hallucinating; blood sugar very low; very dizzy; disorientated; I wasn't able to hold conversation; ... Read more
hallucinating; blood sugar very low; very dizzy; disorientated; I wasn't able to hold conversation; very scary; sweaty; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 37-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0217), dose 2 via an unspecified route of administration in arm left on 25Jun2021 at 17:00 (at the age of 37-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included liver disease from an unknown date and unknown if ongoing. The concomitant medications of the patient included rifaximin (XIFAXAN), propranolol (PROPRANOLOL), bupropion hydrochloride (WELLBUTRIN), celecoxib (CELEXA [CELECOXIB]) and ursodiol (URSODIOL) all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0178), via an unspecified route of administration in arm left on 04Jun2021 at 15:00 (at the age of 37-years-old) 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 not been tested with covid-19. The patient experienced reported that on 25Jun2021 at 18:00 approx 30 min after injection, while shopping, I became very dizzy, sweaty and disorientated. I wasn't able to hold conversation and was rolling and running in circles. I did not know where I was and was hallucinating, very scary and all happened very quickly. Was taken to ER for observation, was told my blood sugar very low. I've never had glucose problems and am not diabetic. The patient underwent lab tests and procedures which included blood glucose decreased was low on 25Jun2021. Therapeutic measures were taken as a result of events that included ate food and observed. The outcome of all the events was reported as resolving.
37 2021-07-19 nerve pain, electric shock sensation Obviously, he wants to treat this and has never pain like electric shocks all over body.; Obviously,... Read more
Obviously, he wants to treat this and has never pain like electric shocks all over body.; Obviously, he wants to treat this and has never pain like electric shocks all over body.; a rash that started on his leg/It is spreading all over his chest, legs, armpits, groin and torso.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date : unknown), dose 1 via an unspecified route of administration on 14Apr2021 as dose 1, single for covid-19 immunisation. Age at vaccination was 37-year-old. Medical history included covid-19 and sick. He very sick with covid 19 a year before that. He clarified about 12 months prior to receiving the vaccine. No prior Vaccinations (within 4 weeks). He not really allergic to anything. He thought he came in contact with poison ivy but he did not. There were no concomitant medications. Caller stated he is a physical therapist calling about the covid 19 vaccine. He talked to someone at the (Department name withheld) to report and the CDC. Ever since the injection, since the first one he has had a rash that started on his leg. The patient experienced a rash that started on his leg/it is spreading all over his chest, legs, armpits, groin and torso on Apr2021. It was two days after the first injection 14Apr2021 about on 15Apr2021 or 16Apr2021 he noticed the rash. He first noticed it midday on his shins and didn't think much of it. He waited a little longer between the first and second doses. Treatment stated he had seen a dermatologist and has done courses of steroids and topicals and nothing helps. It was ongoing and has worsened. Caller does not have at this time. He did two different courses of prednisone and it helped at the start and a lotion, creams, which were also steroids. It kind of tames it but then it came straight back. Advised caller to follow up with primary care physician or local health care provider for treatment recommendations and medical advice. The patient obviously, wants to treat this and has never pain like electric shocks all over body on an unspecified date. He has seen his local health provider. One of his friends had same side effects and all over his arms and legs. Caller stated he will tell him about reporting but that's up to him. Caller declined to complete report on behalf of his friend. No further details provided. They can't prescribe any more steroids and is there something Pfizer is doing as far as treatment and research. The outcome of event rash was not recovered and other events was unknown. Information about lot/batch number has been requested.
37 2021-07-21 cold sweat Lump on Thyroid has Not gone away. Headaches have Not gone away. Pain in shoulder joint has Not go... Read more
Lump on Thyroid has Not gone away. Headaches have Not gone away. Pain in shoulder joint has Not gone away. Endurance is much less. Fatigue. cold sweats.
37 2021-07-21 pain in extremity Head ache; Moderate injection site pain; Pain when raising arm above horizontal; This is a spontaneo... Read more
Head ache; Moderate injection site pain; Pain when raising arm above horizontal; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male 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 15:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. 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 not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 08:00, the patient experienced headache, moderate injection site pain and pain when raising arm above horizontal. The adverse 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 headache, moderate injection site pain and pain when raising arm above horizontal was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
37 2021-07-21 pain in extremity Sore left arm; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the pati... Read more
Sore left arm; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 02Apr2021 at 09:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes mellitus and COVID-19 on an unknown date. The patient was allergic to codeine (MANUFACTURER UNKNOWN). Concomitant medications included insulin glargine (BASAGLAR) and novalog (MANUFACTURER UNKNOWN) both from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, 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 19:00 the patient experienced sore left arm, headache and fatigue. 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 sore left arm, headache and fatigue were recovering at time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
37 2021-07-24 numbness, muscle twitching, nerve pain Patient began developing nerve like pain in his right leg, joint pain, right foot numbness. Went on... Read more
Patient began developing nerve like pain in his right leg, joint pain, right foot numbness. Went on to develop balance disturbances and intermittent episodes of altered mental status as well as twitching of the trunk.
37 2021-07-27 weakness, tingling Likely Giillain-Barre syndrome. Trouble swallowing, shortness of breath, pins and needles starting i... Read more
Likely Giillain-Barre syndrome. Trouble swallowing, shortness of breath, pins and needles starting in extremities the moving to torso then to face over weeks, vision issues (blurring/double vision), confusion and some motor movement challenges, lack of energy/weakness.
37 2021-07-27 burning sensation, tingling Both legs started to burn; Both legs started to burn then tingle; A nickle sizelump appeared on my c... Read more
Both legs started to burn; Both legs started to burn then tingle; A nickle sizelump appeared on my calf and isextremely painful to the tough. It isvery hard all around the lump andfeels like a coin under the skin.; A nickle sizelump appeared on my calf and isextremely painful to the tough. It isvery hard all around the lump andfeels like a coin under the skin.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Mar2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included pseudoephedrine sulfate, loratadine (CLARITIN D 12 HOUR) for unknown indication from an unknown date. The patient had no known allergies to medications, food, or other products. The patient previously, received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration on 11Mar2021 (at the age of 37-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 vaccination within four weeks prior to the COVID-19 vaccine. On 31Mar2021 at 21:00, 6 hours after injection the patient experienced burning sensation in both legs then tingle, immediately after that, a nickle size lump appeared on the calf. The lump was extremely painful to the touch, that was very hard all around the lump and felt like a coin under the skin. The patient did not receive any treatment for the 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 burning leg, tingling, nodule and painful nodule were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
37 2021-07-27 muscle twitching Systemic: muscle twitch-Medium, Additional Details: muscle in vaccinated arm began twitching about 1... Read more
Systemic: muscle twitch-Medium, Additional Details: muscle in vaccinated arm began twitching about 1 hour after dose and has continued every 30 seconds since
37 2021-07-27 unresponsive to stimuli, flushing, seizure, tingling, numbness, tremor Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespon... Read more
Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reported dizziness, then temporarily lost consciousness (associated with a possible seizure) while remaining seated. Patient quickly regained consciousness, then reported that he had also experienced nausea, tingling in fingertips, and sweating. Paramedics arrived and checked patient's vitals, then patient was released. Patient reported (to paramedics) a history of fainting post blood draws. Pharmacist advised patient to remain in the observation area for a minimum of 30 minutes.
37 2021-07-29 burning sensation Shingles; Rash continues to spread and burn when in contact with water or steam; Rash continues to s... Read more
Shingles; Rash continues to spread and burn when in contact with water or steam; Rash continues to spread and burn when in contact with water or steam; This is a spontaneous report from a contactable consumer or other non hcp. A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in left arm on 09Jul2021 16:30 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in right arm on 18Jun2021 05:00 PM (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies. Concomitant medication included vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. On 09Jul2021 18:00 the patient experienced shingles, rash continues to spread and burn when in contact with water or steam. The patient received treatment for shingles with prednisone shot and 30pill pack. The outcome of the events was not recovered. Information about lot/batch number has been requested.
38 2021-01-02 migraine, pain in extremity I started getting a Migraine , but then in the middle of the night I woke up with severe Lower Back ... Read more
I started getting a Migraine , but then in the middle of the night I woke up with severe Lower Back Pain , Joint pain in my shoulders , elbows , and hands bilaterally. Currently My fever is running 100.5-101 F and that?s with taking Tylenol . I still have constant severe low back pain and fatigue . I just feel sick .
38 2021-01-02 pain in extremity Patient with a history of thalassemia and Gilbert's disease, developed severe jaundice three days af... Read more
Patient with a history of thalassemia and Gilbert's disease, developed severe jaundice three days after vaccination. Had mild headache and sore arm but otherwise felt well. Had labs drawn - found to have highly elevated bilirubin (23) and LFTs in the 700s. Was admitted to the hospital and had CT showing Cholelithiasis, choledocholithiasis and minimal intrahepatic biliary ductal dilatation. Left hospital and was admitted to another facility where plan was for ERCP and cholecystectomy. Ultimately unclear if at all related to the vaccination - may be coincidental.
38 2021-01-03 weakness Patient complained of increased shortness of breath, generalized weakness and fatigue with mild coug... Read more
Patient complained of increased shortness of breath, generalized weakness and fatigue with mild cough worsening today and was admitted on 12/25/20. Patient is an employee of the hospital in the ICU and received the covid-19 vaccine on 12/25/20. Patient believes symptoms started after the vaccination. On admission, patient was in sinus tachycardia with O2 saturation 91% on room air. Tested SARs CoV 2 RNA, RT PCR positive on 12/24/20. Transferred to ICU for closer monitoring after transitioning to high flow nasal cannula on 12/26. Patient recovered and discharged on 12/31/20.
38 2021-01-03 tenderness Left thumb swelling and tenderness. Pain and restricted movement in the left hand joints.
38 2021-01-05 feeling hot, flushing Pt received vaccine and was sitting in observation for 10 minutes when he started to complain of fee... Read more
Pt received vaccine and was sitting in observation for 10 minutes when he started to complain of feeling really warm, skin was flush and he was sliding out of his chair. Pt was assisted to stand and move to another room to lay down and have vital signs taken. During this move he passed out and was assisted to the ground. Pt did not hit his head and was laid flat. At this time emergency protocol was activated and Epi Pen was given to left thigh at 10:42. BP 127/64 P. 64 SPO2 100%. respiration shallow at 18. Pt opened eyes immediately after Epi pen administration. He had no recall of syncopal episode. Pt was transported to ER via ambulance for further evaluation.
38 2021-01-05 pain in extremity Woke up with Right Arm Pain and SEVERE Body aches. Took long hot shower, 600mg Motrin.
38 2021-01-05 tremor, weakness Severe headache ("worst headache of my life"), tremor, weakness, fatigue
38 2021-01-06 weakness Stomach Cramping Vomiting Diarrhea Nausea Body Weakness Chills Sweating profusely without a fever
38 2021-01-06 hot flush HYPERtension Hot flush Narrative: BP 148/109 HR 88, patient monitored for an additional 15 minutes, ... Read more
HYPERtension Hot flush Narrative: BP 148/109 HR 88, patient monitored for an additional 15 minutes, repeat BP 147/97 HR 72. Patient recovered and referred to PCP for follow up.
38 2021-01-07 bell's palsy BELLS PALSEY ON LEFT SIDE ON DAY 11 AFTER VACCINE. FUNCTION HAS ALMOST FULLY RESOLVED AFTER A MEDROL... Read more
BELLS PALSEY ON LEFT SIDE ON DAY 11 AFTER VACCINE. FUNCTION HAS ALMOST FULLY RESOLVED AFTER A MEDROL DOSE PACK WAS STARTED.
38 2021-01-07 feeling hot, weakness Officially I fainted, but I describe in detailed events of occurrence below. I was using my laptop ... Read more
Officially I fainted, but I describe in detailed events of occurrence below. I was using my laptop doing some busy work while I waited the 15 minutes after taking the first shot of the Pfizer/BT Vaccine. I had the feeling that I could feel the vaccine coursing through my chest but I thought that was irrational and my mind and nerves playing tricks. I continued to work and let my mind wander for a moment. Next thing I know I was dreaming for a time and then I slowly awakened by the staff calling my name asking "are you OK, do you know where you are?" I was able to answer correctly, but my mind felt fuzzy/foggy where I felt as if I was running on automatic but my conscious mind was not in full control. At the time, It was hard to describe at the time how I was feeling as I was trying to note it down for future reference. All I could put down were simple words and I could not form full statements. Though I was very present in the moment. I can remember the name of the Nurses who I was talking to, and what we were talking about. They took me to be observed for about an hour longer. While I waited, I felt warm, especially in the areas of the back of my head and chest. I was not in any pain, but I was very thirsty. I was also getting pretty hot sitting there, but that may be because of the fact the ER Triage room has full glass wall in full sun. At the end of the hour the sun dropped lower in the sky I felt the normal cold refrigerated Hospital I am used to. I felt weak initially but by an hour I had regained most of my strength by the time the triage nurse took my vitals. After the physician looked over me and my report, they did not give me a reason of concern that would warrant keeping me and let me go home to rest.
38 2021-01-07 tingling Progress Notes (Physician Assistant) ? ? Family Medicine Cosign Needed Expand All Collapse All 1/... Read more
Progress Notes (Physician Assistant) ? ? Family Medicine Cosign Needed Expand All Collapse All 1/8/2021   Date: 1/8/2021   Subjective Patient is a 38 y.o. male who was seen at COVID Vaccine Clinic today for his second dose of the COVID 19 vaccination. He denied any history of previous adverse reactions to other vaccines, but does note he had tingling to the right side of his face after his first dose that lasted 3 days.   He was given the Pfizer vaccination in the right deltoid muscle.During his 15 minute waiting period after the injection, the patient began to experience tingling to right side of face. He denied difficulty breathing, throat tightness, itching, lightheadedness and facial 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 rapid progression of symptoms.   ALLERGY REVIEW OF SYSTEMS: Patient denies chest tightness, shortness of breath, wheezing, rash and dizziness +right sided facial tingling.:   Previous Reactions: Patient states he had right sided facial tingling after receiving his first vaccination, but was not evaluated in the medical bay. He states the numbness and tingling lasted approx. 3 days. Denied weakness in right sided facial muscles at that time.   Objective   Vitals Vitals:   01/08/21 1318 01/08/21 1337 01/08/21 1342 BP: (!) 153/101 137/88 125/85 Pulse: 69 71 60 SpO2: 98% 99% 98%   Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. 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: He is alert and oriented to person, place, and time.     Assessment/Plan Treatment included: antihistamines and Tylenol 1000mg. Tylenol was given by patients wife at 1331. Follow up response to treatment: Patient continues to have tingling to right side of his face. His respirations have decreased however and he is feeling better. BP and HR have improved throughout visit. Patient discharge: Stable to go home and follow up with PCP. Discussed returning to work for the remainder of the day.   Instructed to F/U in ER if symptoms worsen.   Electronically Signed 1/8/2021 1:44 PM    
38 2021-01-09 pain in extremity Around 8pm, legs achy, back sore, chills and low grade fever around 100.5 around 1130pm, severe body... Read more
Around 8pm, legs achy, back sore, chills and low grade fever around 100.5 around 1130pm, severe body aches, malaise. Chills dissipated around 7am but body aches lingered along with fatigue for the rest of the day. Slight chills the night of 1/9. Feels better on 1/10. No body aches and no chills.
38 2021-01-10 night sweats chills, night sweats, headaches, body ache
38 2021-01-11 migraine, tremor Dizziness, Headache, NauseaVomiting, "anxious" "lightheaded", shaking, "migraine" ice pack Narrati... Read more
Dizziness, Headache, NauseaVomiting, "anxious" "lightheaded", shaking, "migraine" ice pack Narrative: at1133: BP-125/79, HR-90, SPO2-99% RA, employee reported feeling anxious, lightheaded, with headache, dizziness, nausea, and shaking. at1148: BP-138/84, HR-79, SPO2-100% RA, stated having migraines that is more intense than usual, ice pack was given, and at1200: employee taken to ER via wheelchair for further observation of migraine, escorted by individual. Employee stated after 1st dose experienced night sweats and headache same day as injected that went away the next day, also reported fatigue the following day after injection and is still experiencing some fatigue today.
38 2021-01-11 nerve pain 7 hours after vaccine, felt fatigued with muscle aches. 15 hours after vaccine, worsening muscle ac... Read more
7 hours after vaccine, felt fatigued with muscle aches. 15 hours after vaccine, worsening muscle aches with nausea. 20 hours, peak of muscle pain, nerve pain, nausea, and pressure in eyes. at 20 hours, Tylenol and Benadryl were taken. At 40 hours post vaccine, reaction subsided with new symptom of left axillary lymph node enlargement and tenderness. Axillary lymph nodes normal 72 hours post vaccine.
38 2021-01-12 facial paralysis, bell's palsy Less than 24 hours of receiving the vaccine I started to experience my jaw locking. Later in the day... Read more
Less than 24 hours of receiving the vaccine I started to experience my jaw locking. Later in the day it began to get worst. I could not blink my left eye and my face started to drop. I went to the ER and they stated that due to vaccine I have Bells Palsy. I was given medication. It is now 4 days in and the symptoms are getting worst. My left eye is now dry due to can not blink. I have serve headaches behind my left eye. I can not eat or chew without having issues.
38 2021-01-13 tingling About 15 minutes after vaccination, employee started to feel tingling and burning sensation in elbow... Read more
About 15 minutes after vaccination, employee started to feel tingling and burning sensation in elbow and wrist. He stated he felt like he was having a reaction. No issues with throat, no shortness of breath but did feel dizzy. Was assisted to the ground and eventually was taken to local ED.
38 2021-01-13 tremor, feeling hot Received vaccine on 1/4/2021 at 15:15 hours. A few minutes after the shot, I felt a warm wave come ... Read more
Received vaccine on 1/4/2021 at 15:15 hours. A few minutes after the shot, I felt a warm wave come over me , kind of felt like passing out but didn't, heart started racing and hands became clammy/shaky. I sat down and after a few minutes it passed so I went back to work. On 1/5/2021 I started to become slightly dizzy with a mild headache lasting all day. On 1/6/2021 dizziness and slight headache persisted with slightly blurred vision. On 1/7/2021 I felt slightly better in the morning but as the day went on the dizziness returned with slight headache and blurry vision. At approximately 16:00 hours I was speaking with my NP, and went over my symptoms. She suggested getting my blood pressure taken. It registered at 154/115. I called my PCP and I was able to be seen the same day. I was given clonidine and it came down but on morning of 1/8/2021 it was back up getting as high as 160/120. Called my PCP back and he prescribed Olmesartan. It seems to have stabilized my BP but he is unsure why the vaccine has caused this and why it is persisting.
38 2021-01-14 burning sensation, weakness, feeling hot didn't have any energy /doing nothing/could not work; didn't have appetite; did not feel well; soren... Read more
didn't have any energy /doing nothing/could not work; didn't have appetite; did not feel well; soreness in left shoulder from injection site; Dizzy; Fever/temperature was 100.8; severe muscle aches; pain all over his body/Feels like a sunburn all over back; pain all over his body/Feels like a sunburn all over back; lost his balance twice; severe headache/Headache came back worse and couldn't open eyes; burning in his back and skin; burning in his back and skin; felt like his body was getting warm and had heat over his eye; felt like his body was getting warm and had heat over his eye; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at site of left deltoid (anatomical location: reported as left shoulder) at 10:30 on 06Jan2021 at single dose for COVID-19 immunization. Medical history included COVID symptoms from 12Mar2020 and COVID tested positive by swab from 24Mar2020. There were no concomitant medications. Clinical course: patient was fine on the 06Jan2021, when he got the vaccine. He did not feel well on 07Jan2021, He had soreness in left shoulder from injection site. In the morning, when he woke up, he felt dizzy and had severe muscle aches and pain all over his body, felt like a sunburn all over his back. His skin and arm were very sore. He took a shower and lost his balance twice in the shower because he was dizzy. He was able to make it to work. At work, he started having a headache. It started to get worse. The burning in his back and skin got worse. He took some paracetamol (TYLENOL) in the morning and the headache started to go down. It came back again worse, so he took paracetamol again. He took two tablets of 500mg paracetamol and he tried to go rest on his break. He took a nap on his break for 15 minutes. When he got up from his nap, he found his achiness was much better. The burning was still there. It was getting less but still there. The headache was less when he woke up from the nap. Headache came back worse and he couldn't open eyes. He took paracetamol. He took two 500mg tablets again. He didn't have any energy sitting at his desk doing nothing. He was not able to look at his computer because of the headache. He could not work on 08Jan2021. He left work and got home and was having headache on the ride home. When he got home, he didn't have appetite. He ate a banana and an orange. He felt like his body was getting warm and had heat over his eye. His temp was 100.8. last night on 07Jan2021. Headache started on 07Jan2021 and he continued to have headache. Fever was coming down, but he was still warm today. He didn't feel that like a sunburn all over his back today. Severe muscle aches and pain all over his body were still there, but less than 07Jan2021. He took ibuprofen (ADVIL) last night on 07Jan2021 and another dose of paracetamol this morning on 08Jan2021. He saw the medical team at the nursing home where he works which were nurses and doctors. They suggested he go home and rest. It was mentioned that patient developed COVID symptoms on 12Mar2020 and tested positive for COVID by swab on 24Mar2020. Could he take the second dose? He didn't know if it is an allergic reaction. He thought that burning over the skin is an allergic reaction. He knew they didn't know a lot about the vaccine. He didn't think he should take the second dose because it would make him miss more work and he already missed work today. Is the second dose recommended if it is an allergic reaction such as burning over the skin? Will Pfizer reimburse him for missing work? Vaccination Facility Type in nursing Home. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No adverse events required a visit to Emergency Room or Physician Office. No prior vaccinations within 4 weeks. No adverse events following prior vaccinations. The outcome of event did not feel well, soreness in left shoulder from injection site, Dizzy, lost his balance twice, didn't have any energy /doing nothing/could not work, didn't have appetite and felt like his body was getting warm and had heat over his eye was unknown; of event headache was not recovered; while of other events was recovering. Information on the Lot/Batch number has been requested.
38 2021-01-14 tingling, numbness right sided facial tingling after receiving his first vaccination/ numbness and tingling lasted appr... Read more
right sided facial tingling after receiving his first vaccination/ numbness and tingling lasted approx. 3 days; right sided facial tingling after receiving his first vaccination/ numbness and tingling lasted approx. 3 days; This is a spontaneous report from a non-contactable other healthcare professional. A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration in right deltoid muscle on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient was seen at the COVID Vaccine Clinic today for his second dose of the COVID 19 vaccination (Lot number: EK9231). He denied any history of previous adverse reactions to other vaccines but does note he had tingling to the right side of his face after his first dose that lasted 3 days. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience tingling to right side of face. Patient states he had right sided facial tingling after receiving his first vaccination but was not evaluated in the medical bay. He states the numbness and tingling lasted approx. 3 days. Denied weakness in right sided facial muscles at that time. Stable to go home and follow up with PCP. The outcome of the events was recovered. No follow-up attempts are possible; information regarding lot/batch number cannot be obtained. No further information is expected.
38 2021-01-15 pain in extremity Right thumb joint pain. I can't hold unto things in my right hand that requires me using pressure f... Read more
Right thumb joint pain. I can't hold unto things in my right hand that requires me using pressure from my thumb. Pain is a 9/10 when holding, grabbing, or using the thumb in any way. When not using the thumb there is no pain at all. I work out everyday and I am no longer to lift weights using my right hand because of the excruciating pain when I try to.
38 2021-01-18 tingling, weakness After I received the vaccine, I was asked to wait for 15 minutes, which I did, later I went to do ch... Read more
After I received the vaccine, I was asked to wait for 15 minutes, which I did, later I went to do chores, though it was rainy and cold a bit. When I came back around 4pm I was feeling okay, no sore on the injection site, unlike my regularly flu vaccines that I mostly feel sore at injection site which lasts about few hours immediately after the flu shot, so it was sort of surprising to see that but later that night, my body starts feeling weak, aches and a tangling on my feet, as the night progresses up to the early morning, I was unusually fatigued and lightheaded with the regression of the muscle aches and subsequently other symptoms started disappearing, notably, I started feeling soreness on the injection site, which lingered to the next day.
38 2021-01-19 pain in extremity I am a registered nurse at hospital. On 12/25, seven days after receiving the shot I started... Read more
I am a registered nurse at hospital. On 12/25, seven days after receiving the shot I started to get right lower leg pain and I kept complaining about it till New Years Day. I had no symptoms of a DVT. I triaged on 1/1/21 and the doctors ordered labs/imaging and the results were as followed: D-Dimer biomarker (+) , Ultrasound of the Rt lower leg ( - ) , CTA showed a PE (segmental right upper lobe pulmonary artery consistent with pulmonary embolus). I was discharged on Xarelto and advised to follow up with a hematologist. On 1/5/2021, I went to hematology and they did a whole bunch of labs. I was sent to get a ultrasound of the leg because the pain persist and they found a clot hidden by my soleus. The plan is to continue on the Xarelto for 6 months. Come back in 3 weeks to scan my leg again and get my lab results. On 1/12/2021, I received the 2nd shot of the Pfizer vaccination.
38 2021-01-20 feeling hot, tingling Developed tingling over body, feeling hot but no fever, fatigue, headache, motion sickness feeling, ... Read more
Developed tingling over body, feeling hot but no fever, fatigue, headache, motion sickness feeling, and a dimness in vision and tunnel vision in both eyes
38 2021-01-20 pain in extremity Cough; muscle aches; joint pain; fatigue; headache; arm pain; This is a spontaneous report from a co... Read more
Cough; muscle aches; joint pain; fatigue; headache; arm pain; This is a spontaneous report from a contactable physician (patient). A 38-year-old male patient received his second dose of BNT162B2 (lot number: EH2184), via an unspecified route of administration in the left arm on 07Jan2021 at 08:30 at single dose for Covid-19 immunization. Medical history was none. The patient had no known allergies. There were no concomitant medications. The patient received his first dose of BNT162B2 (lot number: EH9899) in the left arm on 17Dec2020 at 09:00 for Covid-19 immunization. The patient had no other vaccine in four weeks nor other medications in two weeks. The patient experienced cough requiring albuterol (the patient had never had any history of reactive airway disease or bronchoconstriction), other post-vaccine symptoms included muscle aches, joint pain, fatigue, headache, and arm pain; all on 08Jan2021 at 20:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient had no COVID prior vaccination nor tested with COVID post vaccination. The patient recovered from the events in Jan2021.
38 2021-01-21 weakness 16-40 hours post injection: joint pain/body aches, mid-grade fever, chills, lack of energy, tired. ... Read more
16-40 hours post injection: joint pain/body aches, mid-grade fever, chills, lack of energy, tired. 38+ hours post injection: swelling lymph node in arm pit of arm where injection was administered.
38 2021-01-24 hypersensitivity of all senses possible zoster 1 week after getting first COVID vaccine. Cluster of blisters/lesions on left side ... Read more
possible zoster 1 week after getting first COVID vaccine. Cluster of blisters/lesions on left side of scalp and a few on forehead, hyperesthesia, pain, malaise, swollen/painful lymph node behind left ear. No Eye involvement. Treated with Valacyclovir, now resolved.
38 2021-01-25 flushing, weakness Anaphylactic reaction (flushing, erythema of skin on arms, chest, and neck, tachycardia, diaphoresis... Read more
Anaphylactic reaction (flushing, erythema of skin on arms, chest, and neck, tachycardia, diaphoresis, AMS, weakness); received 0.3mcg epi (Epi-pen) in right thigh after being placed on a litter. EMS contacted. Patient improved prior to EMS arrival and was evacuated for further eval and treatment.
38 2021-01-26 feeling hot Heart racing, feels hot; anxious feeling BP 157/103, HR 114 Snack and juice given. Monitored for 30... Read more
Heart racing, feels hot; anxious feeling BP 157/103, HR 114 Snack and juice given. Monitored for 30 minutes. BP 161/94, HR 71. Reporting feeling better and comfortable going home.
38 2021-01-26 feeling hot Anxious feeling Heart racing Feeling hot BP 157/103, HR 114. Snack and juice given. BP repeated 16... Read more
Anxious feeling Heart racing Feeling hot BP 157/103, HR 114. Snack and juice given. BP repeated 161/94, HR 71. Reported feeling better and okay to leave. Went home.
38 2021-01-27 feeling hot Feeling hot, heart-racing. Axious feeling. BP 157/103, HR 114. Snack given. BP repeated 161/94, HR... Read more
Feeling hot, heart-racing. Axious feeling. BP 157/103, HR 114. Snack given. BP repeated 161/94, HR 71. Reported feelng better. Observed for 30 minutes and sent home.
38 2021-01-28 feeling hot, flushing Flushing/feeling hot, Heart-racing, Anxious feeling. BP 157/103; HR 114. Snack given. BP was repea... Read more
Flushing/feeling hot, Heart-racing, Anxious feeling. BP 157/103; HR 114. Snack given. BP was repeated - 161/94, HR 71). Reported feeling better and feel comfortable going home. Ambulated from clinic.
38 2021-01-31 flushing Developed flushing, diaphoresis, nausea, and eventually syncope about 18 hours after vaccine injecti... Read more
Developed flushing, diaphoresis, nausea, and eventually syncope about 18 hours after vaccine injection. Got up in the night to check on my kids, had been standing for about 2-3 minutes when symptoms started, and passed out in the hallway about 60 seconds after symptom onset. Recovered consciousness within a few seconds, had to lay on the floor for about 5 minutes due to nausea, then got back in bed and went back to sleep. Woke up 3 hours later and felt completely fine except a little fatigue - all other symptoms had resolved.
38 2021-02-01 face paralysis, bell's palsy Bells Palsy, facial weakness,
38 2021-02-01 pain in extremity Extreme pain in my right thumb/ very sharp pain in the middle and base of my thumb; This is a sponta... Read more
Extreme pain in my right thumb/ very sharp pain in the middle and base of my thumb; This is a spontaneous report from a contactable pharmacist reported for himself. A 38-year-old male patient received second dose of bnt162b2 (Lot number: EJ1686), via an unspecified route of administration in left arm on 07Jan2021 09:00 at single dose for covid-19 immunization. Medical history included HTN (hypertension) from an unknown date and unknown if ongoing. Concomitant medication included amlodipine, hctz, amfetamine sulfate (AMPHETAMINE-SALTS). The patient previous received first dose of bnt162b2 (Lot number: EJ1685), via an unspecified route of administration in left arm on 17Dec2020 11:00 AM for covid-19 immunization. The patient experienced extreme pain in his right thumb/ very sharp pain in the middle and base of my thumb on 09Jan2021 05:00. The event was reported as serious per disability. No treatment received for the adverse event. The adverse event result in disability or permanent damage. 36-48 hours after the second dose, the patient started experiencing extreme pain in my right thumb whenever he attempted to use his right hand for something including the simplest of tasks like tying his shoe. When he holds, lift, pull using his right hand he experienced a very sharp pain in the middle and base of his thumb. At first, he thought maybe he hit it on something, but he did not. A week later his wife was at work (she was a hair stylist) and was talking with one of her clients. Her client who is a nurse said recently she had also taken the vaccine (2nd shot) and said the weirdest thing had happened. She told her that she can't hold anything in her right hand, and she has been experiencing unbearable pain in her right thumb when she used it for anything. The pain has lasted almost two weeks now and was not going away. He still speak with the lady who has pain too and she said the same thing and he know it came after the second shot of the vaccine. The outcome of event was not resolved. Facility where the most recent COVID-19 vaccine was administered: Hospital. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Not known allergies.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "pain in thumb" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. 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. ,Linked Report(s) : US-PFIZER INC-2021058634 same reporter/product/event, different patient
38 2021-02-03 facial pain, face paralysis, facial paralysis typical Bell's Palsy; right side facial pain near the anterior right ear and traveling down the faci... Read more
typical Bell's Palsy; right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw; right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw; Weak feeling coming from the jaw; This is a spontaneous report from a non-contactable nurse (wife). A 38-year-old male patient (husband) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 18:00 (vaccine location: left arm) at single dose for COVID-19 immunisation. The patient's medical history included hypogammaglobulinaemia, from years low IGA, chickenpox and shingles in the past. The concomitant medications were not reported. No history and additional vaccines administered on same date. On 20Jan2021 when patient woke up, right now at 09:21 AM, he noticed right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw. Reporter stated this was typical Bell's Palsy and the usual treatment is the same as for herpes zoster; steroids and antivirals is the recommended treatment. Reporter is planning to call the doctor as she feels he needs treatment right away and she will get the doctor to prescribe this treatment. Patient has a weak feeling coming from the jaw. Patient had a history of chicken pox and chronic herpes zoster but this was the first time he had had Bell's Palsy. States the effects are persisting and medically significant. Patient was scheduled for the second dose 09Feb2021. Wanted to know about if patient should get the second dose of the vaccine. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events 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.
38 2021-02-03 numbness No history of severe allergic reactions. Observed for 15 minutes following vaccine injection. Felt... Read more
No history of severe allergic reactions. Observed for 15 minutes following vaccine injection. Felt fine at that point so I was told that I could leave. About 10-15 minutes after leaving (about 25-30 minutes after vaccine injection), I started to feel tingling in the bottom half of my face (most noticeable in the bottom lip and chin area), slight swelling on back sides of tongue, and slight swelling of area under chin at the top of the throat (right side only). I could still breathe, drink, and talk normally. Although symptoms did not seem to be intensifying, I decided to seek care at a nearby urgent care out of caution. I arrived at the urgent care about 10 minutes after the onset of symptoms (about 45 minutes after vaccine injection). Provider evaluated me, administered pepcid and a Benadryl shot, and notified me that if I went into anaphylactic shock that they would administer an epipen and call an ambulance. Vitals were normal and remained normal throughout observation. Symptoms began to abate about 15 minutes after Benadryl injection. Tongue swelling abated first about 15 minutes after Benadryl injection. Active tingling in the chin abated about 30 minutes after Benadryl injection, although light numbness remained. Swelling under chin abated about 45 minutes after Benadryl injection. Provider or staff checked on me every 15-20 minutes. Provider released me from observation after about 2 hours. At that point all symptoms had abated with the exception of slight numbness on bottom half of face, which persisted for several more hours.
38 2021-02-07 night sweats Significant chills; Spiked a fever (100 F at peak); Night sweats; Joint/muscle aches; Joint/muscle a... Read more
Significant chills; Spiked a fever (100 F at peak); Night sweats; Joint/muscle aches; Joint/muscle aches; This is a spontaneous report from a contactable healthcare professional (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported), intramuscularly on the left arm on 19Jan2021 (18:00) at a single dose for COVID-19 immunization at the public health clinic. Medical history included diabetes type II, asthma, high cholesterol and sulfa allergy. Concomitant medications included metformin, montelukast, finasteride, atorvastatin, cetirizine and fluticasone propionate (FLUTICASON). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported), intramuscularly on the left arm on 28Dec2020 (when the patient was 38 years old) for COVID-19 immunization. On 20Jan2021 (06:00), the patient had joint/muscle aches. On 20Jan2021 (19:30), the patient had significant chills for "about 15 minutes"; had spiked a fever (100 F at peak); and had night sweats. The patient had not receive any treatment for the reported events. The outcome of the events was recovered in Jan2021 for 'joint aches', 'significant chills' and 'night sweats'; was recovered on 21Jan2021 for 'spiked a fever'; and was recovering for 'muscle aches'. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
38 2021-02-09 weakness On the 1/3 - felt feverish, achy, and weak. I had a headache. It was bad. It got worse throughout th... Read more
On the 1/3 - felt feverish, achy, and weak. I had a headache. It was bad. It got worse throughout the day. I was nearly calling 911 that night - My wife ended up taking me to urgent care to be seen for headache. CAT SCAN and blood work to rule out aneurisms. I was given: Injection of Toradol -a steroidal anti-inflammatory. Viral inflammation in the brain caused by the vaccine - their diagnosis. Out of work for a week. I experienced symptoms on and off for three weeks - headaches; somedays I feel good and some days I don't feel good - with low energy and weakness and body aches. I have been taking (alternating) ibuprofen and Tylenol - the first week nothing could help but after that the alternating doses did start helping. I haven't had a headache for about a week now. The body aches and low energy is still not resolved - comes and goes.
38 2021-02-10 speech disorder He states he received the vaccine and within 2-3 minutes he experienced dizziness, chest tightness a... Read more
He states he received the vaccine and within 2-3 minutes he experienced dizziness, chest tightness affecting breathing, tunnel vision, disorientation. He asked for help and first they walked him to a chair and then laid him down. He recalls the MD taking his pulse and reporting it as 140. He states his awareness was blurred, but he remembers receiving the epi pen and then feeling better. He recalls sweating but not sure if it was before or after epinephrine. EMS arrived, started an IV and transported him to ER. He denies recalling pruritis, urticaria, oral face throat or tongue swelling, watery eyes, chest pain, cough, wheeze, nausea or emesis. ER observed him several hours. His discharge diagnosis was syncope. He denies recent use of antihistamines or H2 blockers. Per chart review, provider at the event recorded patient c/o hot dizzy, tachycardia, erythema bilat arms, chest with extension to the neck, diaphoresis, difficulty responding (single word only); treated with epinephrine with improved response.
38 2021-02-11 pain in extremity Left arm muscle pain on movement Fever 102 degree Body aches Headache like hangover
38 2021-02-12 muscle spasms Severe muscle spasms, body aches, sore throat and vomiting for 3 days, low blood pressure 6 hrs late... Read more
Severe muscle spasms, body aches, sore throat and vomiting for 3 days, low blood pressure 6 hrs later after the injection. Finally feeling better on the 4th day
38 2021-02-13 bell's palsy, face paralysis I was diagnosed with Bell's Palsy on 2/2/21 after I noticed muscle weakness on the right side of my ... Read more
I was diagnosed with Bell's Palsy on 2/2/21 after I noticed muscle weakness on the right side of my face. Went to Hospital ED per Dr. and was diagnosed after stroke was ruled out. The facial weakness progressed over the next couple of days, and I was unable to move any muscles on the right side of my face. I started recovering on 2/11/21, and have regained some movement back in my face. It currently feels like I have about 10% of my muscle movement back. I did take a five day course of Prednisone 60mg daily, which was started on 2/3/21.
38 2021-02-14 numbness patient developed numbness on face and around mouth that lasted for 10 minutes while driving home a... Read more
patient developed numbness on face and around mouth that lasted for 10 minutes while driving home after the 15 minutes wait time in our office.
38 2021-02-22 cold sweat Shortness of breath, racing heart, light headedness, clammy hands and feet. Feeling of faintness. (R... Read more
Shortness of breath, racing heart, light headedness, clammy hands and feet. Feeling of faintness. (Racing heart only lasted for 15-20 seconds) Treatment was only sitting still, breathing exercises, drinking water. Roughly an hour later breathing is normal, lightheadedness is gone, hands are still clammy and sweaty.
38 2021-02-24 grand mal seizure Per Dr.'s admit note: "Etiology unclear though favor meningitis/encephalitis given 2 days of viral s... Read more
Per Dr.'s admit note: "Etiology unclear though favor meningitis/encephalitis given 2 days of viral symptoms, headache, questionable neck pain, and low-grade fever of 100.6. Had first COVID-19 vaccination on 2/13. Cannot exclude paraneoplastic syndrome; possible hilar mass noted on CXR will need further work-up to rule out sarcoid/malignancy. Concern for viral meningitis. No known sick contacts. Another tonic-clonic seizure occurred around 08:00 on 2/24 AM with vomiting; no overt aspiration though certainly high risk given situation."
38 2021-02-24 tingling, tingling Approximately 15-20 minutes post vaccination patient began to feel "tingly" in his right arm extend... Read more
Approximately 15-20 minutes post vaccination patient began to feel "tingly" in his right arm extending from injection site to hand and all the the way up to his cheek. Moments later he began to have the same tingly feeling bilaterally in his feet. Shortly thereafter he also had some slight nausea/unsettled stomach feeling and also complained of dry mouth. Patient remained on-site for an additional 30 minutes before leaving the site.
38 2021-02-26 burning sensation, pain in extremity Rash and burning sensation on head and neck an hour after the shot was administered and continued th... Read more
Rash and burning sensation on head and neck an hour after the shot was administered and continued through the night. Sore throat also experienced. Both arms felt pain the next morning.
38 2021-03-01 flushing 10 minutes post injection, patient complained of throat fullness and cough, became flush. Patient wa... Read more
10 minutes post injection, patient complained of throat fullness and cough, became flush. Patient was examined by a Nurse who referred him to the Emergency department for further evaluation. Patient was hydrated with NS and medicated with diphenhydramine IV for throat swelling and Dexamethasone IV for cough. Patient was monitored for about one hour until resolution of symptoms.
38 2021-03-03 seizure seizure 3 days after vaccine; This is a spontaneous report from a contactable other health professio... Read more
seizure 3 days after vaccine; This is a spontaneous report from a contactable other health professional. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included seizure. The patient had known allergies: Risperidone. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced seizure 3 days after vaccine on 25Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported seizure 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 2021-03-04 pain in extremity Headache, chills, 103 fever, arm pain. Fever lasted over 24 hours.
38 2021-03-05 numbness, tingling Numbness and tingling bilaterally to arms and feet-cleared by EMS
38 2021-03-06 tingling Tingling sensation in left arm, then right hand, right leg. Resolved in 10 minutes. BP 129/78 (pulse... Read more
Tingling sensation in left arm, then right hand, right leg. Resolved in 10 minutes. BP 129/78 (pulse 66), 99% O2 sat.
38 2021-03-08 pain in extremity Swollen lymph nodes at the collar bone and neck. Acute pain in left arm and shoulder
38 2021-03-09 bell's palsy Bell's Palsy (facial nerve paralysis) started 3/10, 3 days after vaccination . Patient had history o... Read more
Bell's Palsy (facial nerve paralysis) started 3/10, 3 days after vaccination . Patient had history of same so had video visit. started on prednisone
38 2021-03-09 feeling hot ?Pfizer-BioNTech COVID-19 Vaccine EUA" 5 minutes after administration of Pfizer COVID vaccine, patie... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA" 5 minutes after administration of Pfizer COVID vaccine, patient passed out for less than a minute. Patient was alert, knew where he was and what had just happen. He stated he was not experiencing chest pain, shortness of breath, no rash observed. Patient stated he tends to pass out at the site of needles or when he was blood drawn. 10 minutes after passing patient begin to feel lightheaded, skin tone become very pale and patient stated he was hot. Patient passed out a 2nd time and experience 2 body jerk movements for less than a minute. Epi Pen was administered to the patient. Paramedics were called to the scene. Patient become alert and patient stated he need to vomit. Patient vomited profusely. Vitals were taken: BP 100/60mmhg, O2 stat 97%, Temperature 96.5F. Paramedics arrived at scene. Paramedics spoke with patient let him know his vitals were stable and if he would like to be taken down to the ER. Patient declined stated he was feeling much better. On 3.10 patient was contacted and he stated he was feeling great, just experiencing soreness at the site on Pfizer vaccine and Epi pen administration site.
38 2021-03-10 cold sweat Severe fatigue, body aches, chills, fever and cold sweats. Lasted approx 12 hours and then subsided.
38 2021-03-10 numbness, bell's palsy Felt mild numbness on left side of face the same night as I received the vaccine. It got worse the n... Read more
Felt mild numbness on left side of face the same night as I received the vaccine. It got worse the next day. I contacted a doctor via telemedicine and she did an evaluation. She said it was a mild Bell?s Palsy but likely not serious because she couldn?t observe it when asking me to raise my eyebrows or smile ? it was just something I could feel. It went away on its own within another day or so.
38 2021-03-10 pain in extremity It is the ringing in the ear; felt like a siren was going both of his ears; Headache; His arm was hu... Read more
It is the ringing in the ear; felt like a siren was going both of his ears; Headache; His arm was hurting; Throwing up; losing his balance; He was running a temperature; This is a spontaneous report from a contactable consumer. This consumer reported that a 38-year-old male patient (son) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for Covid-19 immunization on 19Feb2021. Relevant history and concomitant drugs were unknown. Relevant concomitant drugs were unknown. The patient previously received the first dose of BNT162B2 in 05Feb2021 for Covid-19 immunization on, when he received the first one he felt headache a little bit and his arm was hurting and all of a sudden he suffered from tinnitus in his ear. He had lost 8 pounds in like 4 days since he got that shot. He weighs not like a 117-118 pounds. When he received the second shot he experienced headache, tinnitus in his ears, which became so worse that he felt like a siren was going both of his ears and he landed up in the hospital plus he was throwing up and he was losing his balance and he was running a temperature and he was still in the hospital. It was the ringing in the ear; felt like a siren was going both of his ears. His arm was hurting. He was in the hospital since Tuesday and ringing in his ear, it would not stop. He said it was started, he always had this but not to this extent he started after the first vaccine that he had. He wanted to know because his ear nose and throat doctor said that another patient had the same reaction (Further clarification was unknown, hence split was not captured) and he wanted to know why is that not listed on the reactions. The outcome of events tinnitus and throwing up was not resolved. Outcome of other events was unknown. Information on the lot/ batch number has been requested.
38 2021-03-12 pain in extremity Vaccine administered at Mega Site Lot EL9266. 2/16/21 Sore arm for one day following first shot.... Read more
Vaccine administered at Mega Site Lot EL9266. 2/16/21 Sore arm for one day following first shot. Lot EN6206. 3/9/21 Sore arm a few hours after second shot. Woke up with body aches and stuffy nose and swollen eyes. Lasted approx 24 hrs
38 2021-03-15 feeling hot, tingling Patient received his pfzier covid vaccine. immediately after he had the vaccine administered, he st... Read more
Patient received his pfzier covid vaccine. immediately after he had the vaccine administered, he stated that he started to feel very hot, dizzy, nausea and tingling down his arm that he received the vaccine in. We immediately got a yoga mat, asked the patient to remove his shirt. He fell to the ground. We placed a cold pack under his head around the neck area and cold paper towels on his head. We took his blood pressure it was 136/88. He started to mention his chest hurting. His past medical history includes fainting in the past (due to low blood sugars) and open heart surgery as a child. He is currently under the care of a cardiologist. More recently he has had several fainting spells which he believes is due to low blood sugar. He stated he had eaten a good lunch around 11:30. It was about 2:30 when this incident occurred. We offered the patient, a banana, orange, chicken sandwich and water. He ate the orange. We called EMS. When they arrived, they checked his blood sugar which it was 95. He started to feel better and his wife drove him to the cardiologist.
38 2021-03-15 pain in extremity he has lost also since he got that shot he had lost 8 pounds in like 4 days. He weighs not like a 11... Read more
he has lost also since he got that shot he had lost 8 pounds in like 4 days. He weighs not like a 117-118 pounds; Headache; His arm was hurting; It is the ringing in the ear; felt like a siren was going both of his ears; This is a spontaneous report from a contactable consumer (parent). A 38-year-old male patient (son) received first dose of BNT162B2 on 05Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. When he received the first one he felt headache a little bit and his arm was hurting and all of a sudden he suffers from tinnitus, It is the ringing in the ear. He is about 5' 9 and he has lost also since he got that shot he had lost 8 pounds in like 4 days. He weighs not like a 117-118 pounds. The outcome of the events was unknown. Information on the Lot/batch number has been requested.
38 2021-03-17 nerve pain Closterfobic in the open air crushing feeling. 4 hours. Major nerve pain through out body. 4 hours.
38 2021-03-18 pain in extremity Sore arm. Resolved 2/24 (about 48 hours after vaccination).
38 2021-03-20 pain in extremity Starting in the evening the day following my vaccinations, my left toe, then foot began to swell and... Read more
Starting in the evening the day following my vaccinations, my left toe, then foot began to swell and ache. The pain continued to increase over the next 12 hours. I believe I have gout. I will be seeking medical treatment on Monday, March 22.
38 2021-03-21 burning sensation Red rash on forearm. Burning sensation.
38 2021-03-21 pain in extremity Sore (L) Arm, Lite headache and tired.
38 2021-03-21 seizure Arm hurt at injection site, upon lifting arm, felt a sensation in arm near injection site and had wh... Read more
Arm hurt at injection site, upon lifting arm, felt a sensation in arm near injection site and had what appeared to be a seizure that lasted around 10-15 seconds. A few moments later another seizure occurred. Resulted in a hospital visit and a follow-up with a neurologist.
38 2021-03-21 tremor othostatic Narrative: The patient looked pale, shaking, reported light headed after got the vaccine... Read more
othostatic Narrative: The patient looked pale, shaking, reported light headed after got the vaccine for COVID 19. The staff in the clinic put him down the ground with feet and legs lifting on the chair. Ice bag provided. At that moment (1250), checked his Vss: BP 103/62,HR 75, 02sat 98%, 10 mins later (1355),his Vss BP 120/80, HR70,02 sat 99%. He stated feeling better, face color turned to pink, the patient said no dizzy any more. Juice provided. Last Time (1330) checked the patient VSs: BP 117/77, HR 87,02 98%. The patient reported feeling OK. He has been released to home.
38 2021-03-24 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: EMS was called. However patient recovered prior to EMS arrival. Contacted patient at 8pm on 03/23/21. Patient stated he was doing fine and did not need to seek additional medical attention as of the time we spoke.
38 2021-03-24 numbness Headache, Myalgia, Fatigue, Hand numbness. Narrative:
38 2021-03-25 flushing Sweating Chills Palpitations Flushing Lightheadedness
38 2021-03-25 muscle twitching, muscle spasms, tingling, pain in extremity pt states he got a couple of hives after taking the vax. He was given Benadryl which helped with th... Read more
pt states he got a couple of hives after taking the vax. He was given Benadryl which helped with the hives. Later that night after going to bed he woke up w/ his muscles and nerves twitching and tingling. He says you can sometimes see the muscles spasms and then other times he feels it tingling under the skin. Pt is still having these symptoms. He had a sore arm for about 48 hours. For about 3 to 4 days he had a faster heart rate and higher blood pressure than normal. He developed a headache that lasted about 2 days. Currently he is having some brain fog and his shoulder and biceps still have a heavy feeling like they are detached from his body along with the muscle twitching and tingling. He does not feel like these symptoms are improving and will see his PCP on 3/29/2021.
38 2021-03-26 cold sweat Patient came up to the desk post vaccine from waiting area. Reported symptoms of queasiness, dizzine... Read more
Patient came up to the desk post vaccine from waiting area. Reported symptoms of queasiness, dizziness. Patient sat down. He was diaphoretic, pale & clammy. Sternal rubbed & patient came back around. Provided Gatorade. Sat in the clinic for further observation.
38 2021-03-27 pain in extremity Left arm soreness, stiffness. It lasted about 12 hours. I was achy all over my body, though that cou... Read more
Left arm soreness, stiffness. It lasted about 12 hours. I was achy all over my body, though that could be due to the rain storm we had overnight. The rain has passed and I am no longer achy in my arm or elsewhere.
38 2021-03-27 pain in extremity Fever, chills, pain in arm 10 hours after injection. Nausea and extreme fatigue with dizziness follo... Read more
Fever, chills, pain in arm 10 hours after injection. Nausea and extreme fatigue with dizziness followed for 48 hours.
38 2021-03-27 tingling 3/28/2021 patient was observed post Covid-19 immunization for 45 minutes . During the observation... Read more
3/28/2021 patient was observed post Covid-19 immunization for 45 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: Tingling around the face and mouth and down the vaccinated left arm.. Assessment : Time of assessment 1138 Alert and oriented. Actions taken: Observation 45 minutes, Vs - BP- 132/99. P- 68, O2- 100% Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/28/2021 10:48 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8733
38 2021-03-27 tremor Post vaccine, patient was being observed and reported dizziness and tremor of the hands. EMS assess... Read more
Post vaccine, patient was being observed and reported dizziness and tremor of the hands. EMS assessed and the patient was transferred to the ED via ambulance.
38 2021-03-27 tremor Syncope Sweating Shaking Tunnel vision
38 2021-03-28 bell's palsy, facial paralysis, weakness Bell's Palsy. Examined on 3/29/2021, he had moderate weakness, House-Brackmann Grade III
38 2021-03-28 migraine Patient describes he started to get a migraine on and off behind left eye and left side of neck star... Read more
Patient describes he started to get a migraine on and off behind left eye and left side of neck starting about 1 week after vaccine received, pain started on 3/23/2021 and has continued since that date, on and off. Taking Tylenol and alternating with ibuprofen to help with the symptoms of pain.
38 2021-03-29 numbness, tingling Tingling and numbness in left hand. Shot was given in left arm. Tingling comes and goes throughout t... Read more
Tingling and numbness in left hand. Shot was given in left arm. Tingling comes and goes throughout the day.
38 2021-03-29 pain in extremity Swollen left foot accompanied by pain Started roughly 10 hours after receiving the vaccine shot. Ha... Read more
Swollen left foot accompanied by pain Started roughly 10 hours after receiving the vaccine shot. Has persisted for 3 days so far Taking ibuprofen and cold foot bath to control swelling. Difficulty walking
38 2021-03-29 tingling I took 1 Advil 2 hours after vaccination (at 3pm on Sat 3/27). and then 2 more Advils at 11p that sa... Read more
I took 1 Advil 2 hours after vaccination (at 3pm on Sat 3/27). and then 2 more Advils at 11p that same day when I started feeling the side effect -- body ache, left arm soreness where I was vaccinated, and chills for about 4hours. It made it really hard to sleep. I woke up the next day on 3/28 feeling extremely fatigued with a bit of body ache. I then took two more Advils that day. By the 3rd day on 3/29 I was back to normal, with the exception of a tingly sensation on my left-hand (note i received the shot on my left arm/shoulder area).
38 2021-03-30 face paralysis, tingling, bell's palsy, facial paralysis Bell's palsy - a feeling of facial paralysis and severe muscle weakness where the neck muscles meet ... Read more
Bell's palsy - a feeling of facial paralysis and severe muscle weakness where the neck muscles meet the lower left jaw. This came on quickly as I was sitting down several hours after receiving my first dose, and then subsided over the course of the next 15 minutes or so. I have however a returning sensation of a weaker form of it today, three days after the vaccination event. - a feeling like I can't fully clench my jaw on my lower left side without a notable tingling sensation.
38 2021-03-30 pain in extremity Pain in left calf leading to development of blood clot above left knee cap near inside of quad; Pain... Read more
Pain in left calf leading to development of blood clot above left knee cap near inside of quad; Pain in left calf leading to development of blood clot above left knee cap near inside of quad; This is a spontaneous report from a contactable consumer. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included U/L fasciatomy in same leg with nerve damage, Blood transfusion, previous clot in femoral during recovery, Shellfish (allergy). The patient has not had COVID prior vaccination. The patient received first dose of BNT162B2 for COVID-19 immunization on an unspecified date (lot number: unknown) at 38-years-old. Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM) taken for an unspecified indication, start and stop date were not reported. On 04Mar2021 16:00, the patient experienced Pain in left calf leading to development of blood clot above left kneecap near inside of quad. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment for the events: Originally treated as cellulitis with doxy. The outcome of the events was recovering. The patient was not tested for COVID post vaccination. Information about Lot/Batch number is requested.
38 2021-04-02 weakness Diarrhea, fever progressing to 101.8 Fahrenheit, chills, weakness
38 2021-04-02 feeling cold, pain in extremity The day after the second shot, fever of 100.8 and chills/ feeling cold. Sore arm.
38 2021-04-02 pain in extremity I am a board certified physician in gastroenterology and internal medicine and work for the Medical ... Read more
I am a board certified physician in gastroenterology and internal medicine and work for the Medical Center. I have no hearing or ear history. Received Pfizer vaccine from work on 12/21/20 L arm IM, no side effects, sore arm for < 24 hours, second dose 1/11/21 L arm IM, no side effects, sore arm for < 24, however, on 1/22/21 work up with muffled hearing and bringing in the left ear only. Called colleague Doctor who started prednisone 50 mg immediately on 1/23/21 and continued for 4 weeks without improvement. Audiometry testing 1/25/21 demonstrated moderate high-frequency hearing loss suggestive of sudden sensorineural hearing loss (SSHL). Emergent CT head and MRI brain and ear were unrevealing. 20 session of hyperbaric oxygen therapy from 1/21-2/21 without substantial improvement. Vasculitis workup negative with normal ANA, CRP, ESR, ANCA, CBC, CMP. 3/21 COVID-19 antibodies test for exposure negative. 4/21 noting more public event reporting of hearing loss and tinnitus associated with vaccines. reports-grow-amid-covid-19-vaccinations/) while I understand there is not causal evidence yet linked, I feel that there is a temporal relationship and odd correlation that needs to be recorded and accounted prospectively further. Vascular surgeon, Hematologist who are treating me for a PE and DVT post ankle fracture and surgery do not correlate the SSHL with my DVT, PE, or anticoagulation. To date 3 audiometry tests demonstrate persistent left-sided moderate high-frequency hearing loss.
38 2021-04-03 burning sensation, feeling hot, feeling cold After taking my 2nd Shot for Booster on the morning of Friday the 5th of 2021. I ate and hydrated fo... Read more
After taking my 2nd Shot for Booster on the morning of Friday the 5th of 2021. I ate and hydrated for the day. At home I was resting when standing up I was overwhelmed with dizziness, nausea, sweats, and then the chills and heat hit. My inner core felt frozen. I couldn't move after standing up and the chills locked every bone in my body I couldn't breathe. Terrified doesn't cover how afraid I was at that moment. Teeth chattering, fingers rigid, and my back was solid. After moments in this state, I put on layers of sweaters to warm myself. The outside temperature was 65-70*C. So not that bad. I was in shock and not long after putting on my sweaters. My skin felt like it was sun burned and all the weight of the clothing was painful. I could not lay down, or even roll on my side for rest. Even standing up made my spin hurt. The muscles in my lower back seized up and the pain was right in the middle of my spin. (The ER Doctors checked and I do not have kidney stones.) I was fighting 99.3+ temp and rising. (This temp is accurate. I have phot evidence.) There was no sleep that Friday night. Saturday morning I called the first available chiropractor and went to that appointment at 2pm. As a new client they don't want to go all out in the first session, but I was in pain with every breathe. Hyperventilating and over breathing was causing issues with my head and stomach. The session was amazing, electro therapy mixed with heavy cracks worked on by a professional did help, but only for a brief period of time. Walking away from the building I was still in more pain than ever. My dad arrived to take me to the ER at roughly 6pm. Doctors gave me fluid and anti inflammatory drip. Potassium and Tylenol. It worked. The pain was unreal and I welcomed anything to end the suffering.
38 2021-04-04 cold sweat nausea, pale and clammy skin
38 2021-04-04 feeling hot rapid heartrate, drop in bp, sweating, turned pale, mild nausea, warmth throughout the body
38 2021-04-06 migraine Migraine, passing out, cysts
38 2021-04-06 nerve pain Patient developed progressive weakness starting in his legs leading to falls and then in his upper e... Read more
Patient developed progressive weakness starting in his legs leading to falls and then in his upper extremities as well. He also developed neuropathic pain. These symptoms began 2 days after vaccine administration. He was seen in the ED and admitted to the hospital on 3/29. He was diagnosed with acute inflammatory demyelinating polyneuropathy (AIDP) and started on PLEX and methylprednisolone. Patient continues to require inpatient hospitalization and significant assistance with his ADLs. He is also experiencing autonomic dysfunction with tachycardia, elevated BP, and diaphoresis.
38 2021-04-07 feeling hot, tingling Paresthesia, warm feelings on legs
38 2021-04-07 pain in extremity Sore arm started feeling hours after vaccine administration and last 48 hours. Effect was transient.
38 2021-04-07 seizure Patient was being observed after vaccine and passed out. While laying on the floor, he seized x 2 f... Read more
Patient was being observed after vaccine and passed out. While laying on the floor, he seized x 2 for about 45 seconds. No memory of seizure/seizure-like activity.
38 2021-04-08 numbness Patient felt groggy, little visual disturbances, shortness of breath--when placed in supine position... Read more
Patient felt groggy, little visual disturbances, shortness of breath--when placed in supine position and elevate feet felt better. Feet became numb but vitals were normal--pulse and 02 stats withing range.
38 2021-04-09 bell's palsy The symptoms were moving from my jaw to my cheek and impacting my vision; feeling feverish accompani... Read more
The symptoms were moving from my jaw to my cheek and impacting my vision; feeling feverish accompanied with body aches; feeling feverish accompanied with body aches; Moderate (level 3) case of Bell's Palsy/I began to feel more intense symptoms in my face, losing the ability to move/control muscles in the right side of my face; Fatigue; a stiff jaw/slight discomfort in my jaw; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 24Mar2021 09:45 (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization. Medical history included high blood pressure from an 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 has not been tested for COVID-19. Concomitant medications included indapamide, and fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number: EL3248) on 04Mar2021 11:45 AM on left arm for COVID-19 immunization. The patient reported that on 24Mar2021 he received his 2nd dose of COVID 19 vaccine. On 25Mar2021 he woke up at 6:30am with fatigue and a stiff jaw. At around 2pm he began feeling feverish accompanied with body aches and it continued until 3:30am of 26Mar2021. During that time, he did not notice any face or jaw discomfort. On 26Mar2021 and 27Mar2021 he had little to no symptoms other than slight discomfort in his jaw. On 28Mar2021 he began to feel more intense symptoms in his face, losing the ability to move/control muscles in the right side of face. The symptoms were moving from his jaw to my cheek and impacting his vision. He reported that this was out of the norm, and it prompted him to contact his healthcare provider. On 29Mar2021 at 1:40, he sought care from his healthcare provider. After a full examination he determined that he had a moderate (level 3) case of Bell's Palsy (reported started on 25Mar2021 07:00). Bell's palsy resulted in Doctor or other healthcare professional office/clinic visit. He was prescribed 80 MG/day of Prednisone for 7 days. The patient has not recovered from the events at time of report. No follow-up attempts are needed. No further information is expected.
38 2021-04-09 tremor Severe headache. Extreme chills and shaking multiple instances. Body temp check twice in 72 degr... Read more
Severe headache. Extreme chills and shaking multiple instances. Body temp check twice in 72 degree room has reading of 94.3 and 94.8 despite active and passive rewarming efforts.
38 2021-04-10 feeling cold, numbness Headache. Also numbness in jaw area and cold sensation inside the mouth and around the jaw as well ... Read more
Headache. Also numbness in jaw area and cold sensation inside the mouth and around the jaw as well as dry mouth.
38 2021-04-10 numbness, tingling TINGLING AND NUMBNESS IN EXTREMITIES
38 2021-04-10 migraine body ache, migraine, fever, joint pain, sore throat, chills
38 2021-04-11 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
38 2021-04-11 pain in extremity Non ending headache since first dose. Can hardly move my right leg its very sore and stiff. Intermed... Read more
Non ending headache since first dose. Can hardly move my right leg its very sore and stiff. Intermediate dizzyness and nausea and extremely tired.
38 2021-04-11 tingling nausea tingle in fingers, monitored in EMS and discharged in stable condition
38 2021-04-12 unresponsive to stimuli, flushing Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Me... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient experienced fainting for 2-3 seconds followed by 10 minutes of nausea/vomiting/flushing. Patient returned to baseline
38 2021-04-13 muscle twitching, tingling Developed typical fever, chills, body aches, headache for 24-48 hours but then developed diffuse ong... Read more
Developed typical fever, chills, body aches, headache for 24-48 hours but then developed diffuse ongoing paresthesias, tingling, muscle twitches and aches (similar to neuropathy that developed following 2009 H1N1 flu vaccine), in addition to status migrainosus x 4 weeks so far.
38 2021-04-13 seizure Patient began seizing after several hours of fever of >100 degrees F, post-vaccination. He was trans... Read more
Patient began seizing after several hours of fever of >100 degrees F, post-vaccination. He was transported by ambulance from his home to the Emergency Department where he experienced another seizure. Patient was hospitalized overnight and discharged with medication for control of seizures.
38 2021-04-13 tenderness Pt received second dose of the Pfizer vaccine 26MAR21. The night of 28MAR21 pt started to get left s... Read more
Pt received second dose of the Pfizer vaccine 26MAR21. The night of 28MAR21 pt started to get left sided chest and neck pain. Sx included point tenderness just below left pectoral and difficulty breathing during inhalation due to pain as lungs expanded. Pt states pain felt like inflammation around upper lung or heart lining that was agitated with movement that lasted for 05 days and went away. 29MAR21 pt was treated at Clinic at 0800 by Physician Assistant LT to rule out cardiac related issues with an EKG that showed normal results. Prescribed Motrin 200mg and Famotidine 20mg that reduced discomfort. Pt was cleared to return to work with no current sx.
38 2021-04-14 cold sweat Patient was dizzy, and pale and clammy. Had slight ringing in the ear . All symptoms lasted about 25... Read more
Patient was dizzy, and pale and clammy. Had slight ringing in the ear . All symptoms lasted about 25 min.
38 2021-04-14 mild one side paralysis, numbness, tingling Left sided numbness, tingling and weakness for first few days after vaccine and then returning sympt... Read more
Left sided numbness, tingling and weakness for first few days after vaccine and then returning symptoms with some additional localized left elbow bony tenderness 8 days post administration.
38 2021-04-14 pain in extremity Right knee (joint) pain. Some upper calf (maybe muscular) some lower thigh (maybe muscular) also rig... Read more
Right knee (joint) pain. Some upper calf (maybe muscular) some lower thigh (maybe muscular) also right leg. Possibly residual joint pain. Dull ache.
38 2021-04-14 tingling About a minute after getting a shot, he started feeling lightheaded. He also felt some anxiousness w... Read more
About a minute after getting a shot, he started feeling lightheaded. He also felt some anxiousness with tingling in his left arm. He says that his symptoms lasted about 20 minutes or so.
38 2021-04-14 tingling Feeling of pinches nerve in left elbow. Tingling in left fingers. Tightness on left side of chest. W... Read more
Feeling of pinches nerve in left elbow. Tingling in left fingers. Tightness on left side of chest. Weak feeling in left arm.
38 2021-04-15 burning sensation Headache, Nausea, Fatigue, Body Ache, Fever, Felt like my blood was on fire, Symptoms lasted 36 hour... Read more
Headache, Nausea, Fatigue, Body Ache, Fever, Felt like my blood was on fire, Symptoms lasted 36 hours
38 2021-04-15 discomfort Headache, Body aches, fatigue, felt like I was developing a fever though I didn't have a high temp. ... Read more
Headache, Body aches, fatigue, felt like I was developing a fever though I didn't have a high temp. Felt some discomfort in taking a deep breath.
38 2021-04-15 numbness Patient complained of lightheadedness and nausea with arm numbness. Patient states this began 5 minu... Read more
Patient complained of lightheadedness and nausea with arm numbness. Patient states this began 5 minutes after administration of vaccine. Patient asked for help at 15 minutes into symptoms Patient continued to improve with resolution of symptoms except for nausea after 30 minutes.
38 2021-04-15 tingling Tingling in feet; BP 110-152; 76-82; HR 81; RR 16
38 2021-04-15 cold extremities Patient received vaccine about 5 minutes later he was pale, cold to touch, slouching and sweating. ... Read more
Patient received vaccine about 5 minutes later he was pale, cold to touch, slouching and sweating. reported not feeling well. reported not being able to hear anything being said to him. Pressure was normal but he responsive but was almost to the point of passing out was sweating profusely. After laying on ground for a few minutes he was responding better said he has poor response to needles . He has passed out previously with needle stick. Emergency services was called patient was evaluated and released in good condition.
38 2021-04-16 feeling hot Pt stated feeling dizzy and woozy, hot/sweaty. Pt had stated previous adverse reactions to needles a... Read more
Pt stated feeling dizzy and woozy, hot/sweaty. Pt had stated previous adverse reactions to needles and vaccines. Pt had BP 110/70, Pulse 60, SpO2 96%.
38 2021-04-17 weakness Slight fatigue after 8 hours, minor body aches after about 10 hours, chills and low grade temp after... Read more
Slight fatigue after 8 hours, minor body aches after about 10 hours, chills and low grade temp after about 12 hours. Woke up with loud ringing ears at about 15 hours after vaccination. The following morning (21 hours after vaccination) ringing ears were less intense, no body aches or chills. Still low energy. 45 hours after vaccine noticed slight fever again. 60 hours after vaccine all symptoms gone except light ringing ears.
38 2021-04-17 burning sensation tested positive for covid19; tested positive for covid19; his heart, if he walks faster or does stai... Read more
tested positive for covid19; tested positive for covid19; his heart, if he walks faster or does stairs he feels his breathing is more short and it takes more time than it usually does to recover from walking the stairs.; roof of mouth is itchy; caller is more tired; had pain in his shoulder; First dose: 15 Feb 2021/Second dose: 04MAR2021; throat becomes a little swollen; Palpitations; congested; burning sensation when he breathed/nose is burning when he breathes; cough; lost smell yesterday morning/laundry to smell something strong and there was no smell; he was "feeling like shit"; he had pressure behind his eyes, 3 out of 10; could not work or do anything; not sleeping well/cannot sleep for the last couple of days; This is a spontaneous report from a contactable consumer (Patient). This 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN6205), via an unspecified route of administration arm (Left shoulder) at single dose on 04Mar2021 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL9267), via an unspecified route of administration Arm (left shoulder ) at single dose on 15Feb2021 for Covid-19 immunisation. The patient medical history included allergies depends on what kind of grass he is around. The concomitant medication included multivitamin daily and lists the brand. The event was described as follows: On an unspecified date patient tested positive for Covid19, roof of his mouth is itchy, foggy, tired, at night he was kind of tired, pain in his shoulder, throat becomes a little swollen it does not hurt at all but it is a little bit tight. On 31Mar2021 patient tested positive for covid, palpitations, congested, had a burning sensation when he breathed, he had a little cough, lost smell, "feeling like shit", cannot sleep for the last couple of days", pressure behind his eyes, 3 out of 10, and could not work or do anything had an apple cider vinegar gummy and it had no taste so he went to the laundry to smell something strong and there was no smell, nose is burning when he breathes, if he walks faster or does stairs he feels his breathing is more short, it takes more time than it usually does to recover from walking the stairs, could not work or do anything COVID 19 test 05Apr2021 positive, On Saturday he was not sleeping well which is a big issue, he slept 4 hours and heart now is ok but when he goes downstairs and up he is jogging a little, run the stairs and it is harder to recover and breathe and that started at the beginning. Patient had no meat or fish for 2 weeks to detox his body and he is starting to eat meat slowly. States he tested positive for COVID-19 5 weeks after his 2nd dose. Treatment received for adverse event 500 mg Tylenol, Mucinex, Tylenol, and vitamins B and C, Mucinex a nose wash with salty spray. The patient underwent lab tests and procedures which included S1-RBDIGG antibody (positive) on 02Apr2021, Blood Test (IgM and IgG together), COVID-19 test (tested negative 30Mar2021 and tested positive 31Mar2021), covid19 PCR test (one was negative and one was positive), SPO2 is 98. The outcome of the event was Unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Dyspnoea, Oral Pruritus, Pharyngeal Edema, Palpitations, Nasal congestion, Burning sensation, Cough, increased intraocular pressure and sleep difficulty cannot be excluded.
38 2021-04-17 facial paralysis Symptoms of bells palsy with right sided facial droop ~72 hours after receiving the vaccine
38 2021-04-18 feeling hot Vasovagal episode 5 minutes following vaccination administration (became hot and diaphoretic). HR 4... Read more
Vasovagal episode 5 minutes following vaccination administration (became hot and diaphoretic). HR 44, SBP 100. Received IVF enroute by ambulance to emergency department. Evaluated in emergency department, asymptomatic, and discharged home.
38 2021-04-20 burning sensation burning feeling in legs like a sunburn
38 2021-04-20 muscle spasms Tired/cramping muscles and Fatigue starting 14 hrs after vaccination
38 2021-04-20 trigeminal neuralgia I started experiencing stabbing pain in the top of my head then the teeth in my bottom right jaw sta... Read more
I started experiencing stabbing pain in the top of my head then the teeth in my bottom right jaw stared to hurt after about 4 days of random headaches then it became unbearable and I thought I had a tooth infection. The whole right side of my head hurt terribly so we went to the emergency room and they suggested Trigeminal Neuralgia gave me morphine and sent me home the next morning I couldn?t take the pain in my head so we went to hospital and spent 5 days there where they also suggest that it?s Trigeminal Neuralgia I am now on gavapentin and triliptal.
38 2021-04-21 night sweats Symptoms of the following: Late PM of 4/17/2021 into early AM of 4/18/2021: Fever >100.4*F , body ac... Read more
Symptoms of the following: Late PM of 4/17/2021 into early AM of 4/18/2021: Fever >100.4*F , body aches, muscle aches, chills, headache, fatigue. 4/18/2021: Fever >100.4*F, body aches, muscle aches, chills, headache, fatigue, loss of appetite 4/19/2021: Fever >100.4*F, body aches, muscle aches, chills,, fatigue, SLEPT ALL DAY and NIGHT, bad night sweats, loss of appetite. Lower abdominal pain over my bladder and right lower abdomen 4/20/2021: Fever >100.4*F, body aches, muscle aches, chills, headache, fatigue, slept a lot again, loss of appetite. Lower abdominal pain over my bladder and right lower abdomen. NEW COUGH, really bad night sweats and congestion. LOSS OF SMELL 4/21/2021: Felt a bit better in the morning, but had a fever later and throughout the day, body aches, muscle aches, chills, headache, fatigue, COUGH, & LOSS OF SMELL. 4/22/2021: Feeling a bit better, no fever today. Had really bad night sweats, so bad I had to change my clothes and sheets because they were soaked, able to work again today. Still have a COUGH. Also - my wife had her 2nd Moderna vaccine on 4/15/2021 and was ill on Friday.
38 2021-04-22 flushing Flushing, sweating, dizziness, vitals wnl.
38 2021-04-22 tenderness, pain in extremity Sore and tender in arm, minor. Some pain into neck, for only a few hours after. Fatigue within a few... Read more
Sore and tender in arm, minor. Some pain into neck, for only a few hours after. Fatigue within a few hours, persisting over 3 days. Fever, chills after 30 hours overnight. Sharp headache pain after 30+ hours for about one day. Congestion, runny nose, watery eyes after 20 hours and persisting for 4 days. Some muscle ache for 3 days.
38 2021-04-23 numbness c/o numbness to arm that was vaccinated. VS WNLs, symptoms resolved after 15 minutes and cleared by ... Read more
c/o numbness to arm that was vaccinated. VS WNLs, symptoms resolved after 15 minutes and cleared by medical provider to go home.
38 2021-04-24 pain in extremity, migraine passing out/ passed out; fainted; Vomited all over self; Blood pressure: Low, experiencing hypotensi... Read more
passing out/ passed out; fainted; Vomited all over self; Blood pressure: Low, experiencing hypotension; Lethargy; Pains in legs; Pain in lymph nodes on left side; Migraine headache/ headache; Felt unwell; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: ER8732, expiration date: 31Jul2021) via an unspecified route of administration, administered on the left arm on 30Mar2021 09:00 at a single dose for COVID-19 immunisation. Medical history included ongoing asthma, thyroid cancer, thyroid removed, rhinitis, allergic to eggs (ongoing). Concomitant medications included calcium since they took out part of parathyroid, levothyroxine for Thyroid removed and calcitriol taken for Better absorption of calcium; and all were ongoing. The patient previously received Tetanus shot on an unspecified date in 2021 (3 weeks to a month prior to getting the first dose of the Covid-19 vaccine) with no adverse events. Patient was calling to report adverse side effects that he experienced 2 days ago on 07Apr2021 after having the first dose of the Pfizer Covid-19 vaccine. He said that on 07Apr2021, he was taken ill in an ambulance after passing out and vomiting all over himself and his wife. His wife may have saved his life by keeping him from falling down when he fainted. He was taken in an ambulance to the emergency room after he passed out. He said that it was an unpleasant experience as he had to strip down all of his clothes because they had vomit all over them and change in front of the paramedics before being placed on a stretcher and taken to the emergency room. While in the emergency room, he had a CT scan, bloodwork, and checked body movement by having him follow a finger and various other regular tests. He mentioned that the emergency room physician determined that in likelihood, the reason that he passed out and vomited on himself was a side effect from the Pfizer vaccination. He talked to his physician yesterday. His physician explained to him that because of his health background, what happened following the first dose of the Covid-19 vaccine, and due to the severity of things, the physician believed that it wouldn't be a good idea for the caller to get the second dose of the Covid-19 vaccine given his reaction. The physician stated that it was up to him whether or not he got the second dose of the Covid-19 vaccine. He had his first dose of the Covid-19 vaccine on 30Mar2021. He began to feel unwell the following day of the Covid-19 vaccine (31Mar2021), experiencing lethargy, pains in his legs and migraine headache. He reported that he got progressively worse and thought he was having a thyroid issue. He reported that the physicians in the emergency room couldn't really determine what the cause of the fainting episode could be as all lab work and the CT scan came back normal. The emergency room physician thought that the caller experienced the fainting episode and vomiting due to the Covid-19 vaccine. He experienced a headache and pain in his lymph nodes on the left side. He took Tylenol and was ok. The next day, 31Mar2021, he didn't feel too well but was ok. He reported that for a few more days following 01Apr2021, he felt not too bad. He didn't have a temperature or a fever and didn't think he was suffering from any specific flu like symptoms. The facility where the vaccine was administered was in a Medical Facility, outpatient hospital like a walk-in center. The event passing out resulted in Emergency room visit. The patient underwent lab tests and procedures on 07Apr2021 which included, potassium levels: normal, blood pressure: low, experiencing hypotension, thyroid levels were normal, CT scan normal and checked for diabetes: negative. Outcome of the events lethargy, pain in legs and migraine headache was recovering, pain in lymph nodes on left side recovered on 31Mar2021 while unknown for the other events.
38 2021-04-24 seizure Convulsion; Syncope; This is a spontaneous report from a contactable consumer (patient). A 38-year-o... Read more
Convulsion; Syncope; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:15 (2:15 PM) (Batch/Lot Number: ER8729) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no covid prior vaccination and not covid tested post vaccination. There were no other vaccines in four weeks. It was reported that the patient experienced Syncope and Convulsion on 08Apr2021 at 14:30 (2:30 PM). The outcome of the events was recovered in Apr2021. No treatment for the reported events. The event resulted in Emergency room/department or emergent treatment.
38 2021-04-27 muscle spasms Severe body aches and muscle spasms. Shoulders, arms, back and hip area. Shoulders and upper arms... Read more
Severe body aches and muscle spasms. Shoulders, arms, back and hip area. Shoulders and upper arms are the worst though. I?ve drank a lot water, Gatorade, took Ibuprofen and ate a banana for potassium but still experiencing the muscle pain and tightness. It has only been 2 days though but I was advised to report it.
38 2021-04-30 weakness First vaccine dose 3/26/21 First health event 4/7/21: pre-syncope and palpitations Second vaccine d... Read more
First vaccine dose 3/26/21 First health event 4/7/21: pre-syncope and palpitations Second vaccine dose 4/16/21 4/18/21: strange heart feelings on any exertion, pre-syncope, weakness, malaise, winded by even walking the dog, hands turn purple, weird thump/click in chest, visual changes (seeing colors or spots, greying of vision, migraine-like hallucinations), shortness of breath Episodes like the one described on 4/18 daily, especially in the morning and on exertion until now, 5/1/21 Seen in the ER on 4/19/21 and 5/1/21. EKGs normal, CBC and metabolic panel largely normal. Holter monitor 4/21/21-4/26/21 placed by healthcare Center; hasn't been read yet.
38 2021-04-30 pain in extremity Chills; Fever started about 14 hours post vaccine; Body aches started about 10 hours post vaccine.; ... Read more
Chills; Fever started about 14 hours post vaccine; Body aches started about 10 hours post vaccine.; Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 30Mar2021 at 11:00 (Batch/Lot Number: EL3247) at 38-years-old as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 for COVID-19 immunization on 09Mar2021 (Dose 1, 11:00, left arm, Lot EL3247). On 30Mar2021 at 21:00, the patient experienced body aches started about 10 hours post vaccine (non-serious). On 31Mar2021 at 01:00, the patient experienced chills (non-serious) and fever started about 14 hours post vaccine (non-serious). On an unspecified date in 2021, the patient experienced sore arm (non-serious). The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
38 2021-04-30 tremor, feeling cold, feeling jittery 12 hours after shot, got severe cold shakes. Had to pile blankets on to sleep but still jittering. M... Read more
12 hours after shot, got severe cold shakes. Had to pile blankets on to sleep but still jittering. Morning after, bad headache and sore everywhere.
38 2021-05-02 speech disorder Immediately after given the shot my lymph nodes began to swell. I am having difficulty swallowing, e... Read more
Immediately after given the shot my lymph nodes began to swell. I am having difficulty swallowing, eating, speaking, and my salivary glands are creating an enormous amount of spit. I am in a great deal of pain and fatigue. I have taken ibuprofen but it only helps for a couple of hours. It is day 5 since the shot and it does not seem to be going away. If symptoms persist I will not take the second dose of covid.
38 2021-05-03 cold sweat Awoke 14 hours after injection with high fever, cold sweats, intense kidney pain, and severe nausea.... Read more
Awoke 14 hours after injection with high fever, cold sweats, intense kidney pain, and severe nausea. Could not stand without experiencing dizziness, tunnel vision, and fainting sensations. Symptoms began to improve within 12 hours of onset, but patient had to stay home from work due to inability to perform basic functions in an office environment. Kidney pain and low fever persisted for 2 days.
38 2021-05-03 migraine Severe migraines severe pain in arm numbness in arm where shot was given irritability loss of sleep ... Read more
Severe migraines severe pain in arm numbness in arm where shot was given irritability loss of sleep loss of appetite weight loss emotional stress anxiety
38 2021-05-03 muscle twitching, tingling Confusion, trouble concentrating/gathering thoughts. Twitching/tingling sensation on face (on the ri... Read more
Confusion, trouble concentrating/gathering thoughts. Twitching/tingling sensation on face (on the right side, same side as where the shot was administered). Chills, body aches.
38 2021-05-03 pain in extremity After the original pain on my left shoulder, I have excruciating pain when ever I do most things. It... Read more
After the original pain on my left shoulder, I have excruciating pain when ever I do most things. It hurts from the elbow up my arm all the way to the left side of my back. Muscle pain, like I am being stab by a sharp knife when ever I make movements with my left arm.
38 2021-05-05 cold extremities About an hour after the injection, my left arm from site down has gone ice cold. Have not had swelli... Read more
About an hour after the injection, my left arm from site down has gone ice cold. Have not had swelling or soreness as of yet. The left arm is ice cold and white compared to my right arm. Did not experience this with the first COVID-19 shot or any other vaccine I have received prior.
38 2021-05-06 tingling Pt stated that they were feeling diaphoretic and "tingling" immediately after their first Pfizer vac... Read more
Pt stated that they were feeling diaphoretic and "tingling" immediately after their first Pfizer vaccination in their left arm. Pt was laid on the ground in a Trendelenburg position and then felt better. After standing patient became dizzy. Last oral intake was at 08:30 hours. Pt was given water and pretzels. Last Vitals conducted 16:25 hrs HR: 97, R: 18, BP: 140/87, SPo2: 98%. Pt was lucid and aware of their surroundings with AxO-4.
38 2021-05-08 feeling hot very hot 101 to 105 temperatures at times but keep down to 101 blood pressure 140 118 80 injecti... Read more
very hot 101 to 105 temperatures at times but keep down to 101 blood pressure 140 118 80 injection arm hurts a lot massive headache more on the front " sensitive to bright lights can't really go outside
38 2021-05-08 numbness, pain in extremity Starting 20 minutes after injection, my left hand went numb for 2 hours. Starting 1 day after inject... Read more
Starting 20 minutes after injection, my left hand went numb for 2 hours. Starting 1 day after injection, my left arm ached for 2 days and I was mildly fatigued.
38 2021-05-08 pain in extremity, numbness Similar reactions to first dose, but accelerated and more intense. About 2 minutes after injection, ... Read more
Similar reactions to first dose, but accelerated and more intense. About 2 minutes after injection, burning at site lasting about three minutes. About 10 minutes after injection, numbness of left hand lasting about one hour. About 12 hours after injection, soreness of left arm lasting about 24 hours, and chills. About 24 hours after injection, noted body temperature about two degrees above usual (thermometer runs low). Lowered one degree the next day.
38 2021-05-11 weakness pneumonia; Extreme weakness; increased coughing; This is a spontaneous report from a contactable con... Read more
pneumonia; Extreme weakness; increased coughing; This is a spontaneous report from a contactable consumer (the patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number ER8736), via an unspecified route of administration on 23Apr2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient has a known allergy to penicillin. Prior to vaccination, the patient had not been diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient reported that she experienced extreme weakness beginning at 9:00 on 24Apr2021 which was still occurring four days later. She experienced increased coughing and was diagnosed by Chest X-ray with pneumonia on 27Apr2021. The events required an Emergency Room visit. The patient experienced pneumonia on 27Apr2021with outcome of recovering, extreme weakness on 24Apr2021 at 09:00 with outcome of recovering and increased coughing on 24Apr2021 at 09:00 with outcome of recovering. The patient underwent lab tests and procedures which included x-ray: pneumonia on 27Apr2021. Therapeutic measures were taken as a result of pneumonia, extreme weakness and increased coughing and included the administration of a "Z-Pack." Additional information has been requested.
38 2021-05-11 pain in extremity Fatigue; sore injection site and arm; sore injection site and arm; This is a spontaneous report from... Read more
Fatigue; sore injection site and arm; sore injection site and arm; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 09Feb2021 at 17:30 (at the age of 38 years old) (Lot Number: em9809, unknown expiration) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue and sore injection site and arm on 10Feb2021. No other vaccine in four weeks. The patient did not receive treatment for the events. The patient was not diagnosed with COVID prior to vaccination and was not tested for COVID post vaccination. The patient had not yet recovered from the events. No follow-up attempts are possible. No further information is expected.
38 2021-05-11 pain in extremity Severe Arm pain 12hours following injection. Extremely painful to move arm Severe Abdominal pain, fe... Read more
Severe Arm pain 12hours following injection. Extremely painful to move arm Severe Abdominal pain, felt like burning sensation in stomach, bent over in pain. Occurred within window of 12 hours to 24 hours post shot. Skin color turned pail white, including lips during abdominal pain and diarrhea. Explosive Diarrhea occurred 12 through 24 hours post injection. Symptoms were most intense and lasted 12 hours through 24 hours post injection, all self resolved within 30 hours post injection.
38 2021-05-12 weakness Unable to concetrate Lack of energy of any kind Headaches
38 2021-05-12 unresponsive to stimuli Client stood up and stated he felt lightheaded,I walked over and sat client down removed his mask an... Read more
Client stood up and stated he felt lightheaded,I walked over and sat client down removed his mask and asked hi to take some breathes, as I called for RN client passed out and fell out of the chair to the floor. Client was unresponsive for less than 30 seconds. Client then was A& O x 3. denies pain or discomfort. PERRLA, strength equal on both sides. Vital signs BP 138/ 80 P 64 R 22 SP02 97% temp 36.9 C. EMS was called and @ nurses were present during event. Client ambulated without difficulty to stretcher and left with EMS for further evaluation.
38 2021-05-14 tingling, flushing About 5 minutes after the injection I get a tingling feeling all over my body. That quickly subside... Read more
About 5 minutes after the injection I get a tingling feeling all over my body. That quickly subsides. Then my heart rate jumps from 75 to 140. My face goes flush and I feel like I am going to pass out. This happened on the first shot so I purchased a blood oximeter for my second and watched it closely. My blood oxygen never went below 96 and mostly remained at 98. Once my pulse hit 140 it immediately began to fall back to 75. About the time the nurse I alerted got there is was back to normal. I do not feel sick at all after either shot. Sure wish I knew what this reaction I am having was.
38 2021-05-15 slurring, weakness Brother felt dizzy and saw double vision with left side body fatigue which was diagnosed as a stroke... Read more
Brother felt dizzy and saw double vision with left side body fatigue which was diagnosed as a stroke. He has bleeding in the back of his brain. Went to the ER at Hospital and took a CT Scan and MRI which showed bleeding. Brother had normal blood pressure and everything was fine with him but the stroke happened after a week of his 2nd Covid-19 vaccine dose. He lost strength in his left part of the body and had a speech slur and double vision. He had to wear an eye patch and had a headache. Hospital said no surgery was needed and transfered him to Rehab for rehab. He is currently there getting treatment.
38 2021-05-16 tremor Within 1-2 minutes of receiving Pfizer vaccine, patient start shaking uncontrollably. We kept checki... Read more
Within 1-2 minutes of receiving Pfizer vaccine, patient start shaking uncontrollably. We kept checking his BP and HR, and although his BP was stable the entire time, his HR started out at 109 and gradually kept dropping. After 3-4 minutes of shaking, we called an ambulance and they took over monitoring the patient's vitals. It was determined that his vitals were stable, his blood sugar level was 60, and after a while, the patient stopped shaking. He was released to leave by EMT.
38 2021-05-18 numbness, tingling Pharmacist administered vaccine on upper right deltoid (intramuscularly). Patient reports a tingling... Read more
Pharmacist administered vaccine on upper right deltoid (intramuscularly). Patient reports a tingling in the right arm that traveled to the right index finger after vaccine administration. The reaction occurred almost immediately. The patient was asked to remain seated to be monitored. After a few minutes the patient reports the tingling subsided. However, patient reports his right index finger is numb. We will continue monitoring and follow-up in two weeks on 06/02/2021.
38 2021-05-21 pain in extremity Sore arm day one Day two upper back infamation with knot Muscle tireness
38 2021-05-22 tremor One day and a half after taking 1st dose of Pfizer vaccine, I woke up from sleep with chest tightnes... Read more
One day and a half after taking 1st dose of Pfizer vaccine, I woke up from sleep with chest tightness, heart discomfort, shortness of breath, unusually fast heartbeat, shakiness and I couldn't sleep. Next day, I went to the emergency department to have a complete heart check-up. All results came back ok. However, discomfort in chest lasted for three days and I had troubled sleeping. It was felt like myocarditis.
38 2021-05-25 cold sweat AE: Patient had not eaten prior to vaccine, started getting dizzy and clammy after receiving vaccine... Read more
AE: Patient had not eaten prior to vaccine, started getting dizzy and clammy after receiving vaccine. Tx: no medications, Symptoms improved with crackers and water. outcome: patient improved spontaneously without medication. patient was discharged home.
38 2021-05-26 nerve pain, involuntary muscle movements, tingling Other weird symptom; runny nose; Fever; cold; cold and flu like symptoms; headache; sinus pressure; ... Read more
Other weird symptom; runny nose; Fever; cold; cold and flu like symptoms; headache; sinus pressure; Sinus drainage; congestion; nerve shoot through his head down to his arm; tingling sensation that would usually last for less than a second; head or eye movement; head or eye movement; dizziness like the feeling one gets before one passes out; This is a spontaneous report from a contactable consumer (patient). A 38-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8737), via an unspecified route of administration, administered in right arm on 12Apr2021 14:00 at age of 38 years as single dose for covid-19 immunisation. Medical history included mystery cough from 2018 and not ongoing, seasonal allergies, used an arnuity inhaler for this, ADHD and depression. Concomitant medications included escitalopram oxalate (LEXAPRO) from Sep2020 to Apr2021 for depression; bupropion from Aug2020 to 20Apr2021 for depression; amfetamine sulfate (AMPHETAMINE SALTS) from 2018 and ongoing for attention deficit hyperactivity disorder. Around 14Apr2021, he had cold and flu like symptoms. He said he had headache, and sinus pressure, drainage and congestion. He said he felt dizzy, and he compared his dizziness to a feeling one gets before one passes out. He said it is associated with head or eye movement, and that there was a nerve shoot through his head down to his arm. This was accompanied by a tingling sensation that would usually last for less than a second. He said this reaction lasted for 2 and a half weeks. Patient mentioned that he consulted his physician, and was prescribed with doxycycline, which helped with the relief of his cold and flu like symptoms, as well as the congestion. He said it has been cleared for 5 days now. On 17Apr2021, patient said he had fever with a temperature of 100 F. He was concerned because the fever had not subsided ever since. On 17Apr2021 he had onset of fever which was ongoing. He was struggling to narrow down the choices here. He was grasping at straws trying to figure out if this ongoing fever fits in the realm of rare side effects of Pfizer Covid-19 Vaccine and asked for further information regarding the fever. He later mentioned he also had cold-like symptoms and an other weird symptom. Fever was typically in morning temperature was 100.2 to 100.5 degrees Fahrenheit then got to about 101 degrees Fahrenheit in the afternoon. Cold-like symptoms was for the first 2.5 weeks had headaches, sinus-related symptoms like runny nose, congestion, sinus pressure. He thought the sinus pressure in particular could be associated with the other weird symptom he had. One of patient's sons daycare had a cold going around his class on 14Apr2021; some of the kids went home with colds and fever so he initially chalked this up to that. Otherwise he did not think so. As a kind of cover her but his doctor did prescribe doxycycline which he just finished the last dose so been on that for 10 days at 100mg twice daily. He thought due to that any of the sinus symptoms he had have dropped. He felt cured of those other than fever; only fully recovered completely about 5 days ago (06May2021). Patient had COVID PCR test: First test in Apr2021, probably on 19Apr2021 or 20Apr2021. Not admitted to hospital, no ER visit, but went to hospital that his physician was associated with to have chest x-ray (Nothing notable found) and blood panel (Nothing notable found, didnt lead to anything. Standard blood work nothing notable found. White blood cell-nothing notable found.) done on 24Apr2021. COVID antibody test on May2021 was positive (IgG positive for COVID antibodies, IgM negative, no active COVID). COVID PCR test in Apr2021 and 26Apr2021 was Negative for COVID. AE (virtual visits for the fever) required a visit to physician office. Pfizer Covid-19 Vaccine delayed twice now; was supposed to get second dose on 03May2021 but since had a fever been told he can't. Outcome of event fever was not recovered and the other events was recovered on 06May2021. Follow-up attempts are needed. Further information is expected.
38 2021-05-26 pain in extremity, feeling hot Headache, light headed, feeling hot without fever, arm soreness fatigue
38 2021-05-27 pain in extremity I got gout in the big toe fingers in both my legs just 3 days following the 2nd vaccination shot, re... Read more
I got gout in the big toe fingers in both my legs just 3 days following the 2nd vaccination shot, resulting in immense pain in my legs and making me completely unable to walk. I have been into an urgent care where they confirmed it is indeed gout and no swolenness due to fracture or infection. I never had history or symptoms of gout or similar kind of illness ever earlier. I do exercise regularly, do not smoke or take alcohols, have properly maintained dietary habits and keep myself well hydrated. Given such lifestyle, the occurence of gout at an age of just 38 seems remote. So I have my doubts on the vaccine side effects. JUST A DISCLAIMER, I MAY BE WRONG.
38 2021-05-28 weakness, pain in extremity Sore arm; feeling weak; headache; This is a spontaneous report from a contactable consumer (patient)... Read more
Sore arm; feeling weak; headache; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 26Feb2021 at 12:00 PM at 38 years, as single dose, for COVID-19 immunisation. Medical history was none. The patient did not have COVID-19 prior to vaccination. Patient had no known allergies. Concomitant medications were not reported. The patient experienced sore arm (non-serious) on 27Feb2021 at 06:00 AM with outcome of not recovered, feeling weak (non-serious) on 27Feb2021 at 06:00 AM with outcome of not recovered, headache (non-serious) on 27Feb2021 at 06:00 AM with outcome of not recovered. The patient has not been tested for COVID-19 post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
38 2021-05-28 pain in extremity mild fatigue; mild body aches (legs); Sore arm; This is a spontaneous report from a contactable cons... Read more
mild fatigue; mild body aches (legs); Sore arm; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 13:00 (Batch/Lot Number: EL3247), at the age of 38 years, as single dose for covid-19 immunisation. The patient previously took bnt162b2 on 04Feb2021 01:00 PM (at the age of 38 years), first dose, lot number=EL3247, in Left arm. The patient medical history was not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Concomitant medication included ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES) taken for an unspecified indication, start and stop date were not reported. The patient experienced sore arm on 25Feb2021 (about 6-48 hours after 2nd shot; peak arm soreness 18-36+ hours), mild fatigue on 26Feb2021, mild body aches (legs) on 26Feb2021 (beginning 18-40 hours after 2nd shot). The patient was not treated. The events were non serious with outcome of recovering. No follow up attempts are possible. No further information is expected.
38 2021-05-29 migraine Migraine
38 2021-05-30 feeling cold Started getting very achy about 18 hours after my second shot. I had no side effects with the first ... Read more
Started getting very achy about 18 hours after my second shot. I had no side effects with the first one. Cold chills and bad headache. Nauseous waves coming on and off.
38 2021-05-31 facial paralysis, bell's palsy 1st shot 4/22/2021 No immediate adverse reaction. Sudden facial paralysis on left side started aprox... Read more
1st shot 4/22/2021 No immediate adverse reaction. Sudden facial paralysis on left side started aprox 2½ weeks later (5/9/2021). Hospital diagnosed me with Bells Palsy on 5/10/2021 after I went to the emergency room . The bells palsy has corrected itself and now I owe $13,872.05 to the hospital because I have no insurance and cannot afford to pay it.
38 2021-06-01 pain in extremity Mild chest pains throughout the day after the vaccine shot. Went away the following morning. No othe... Read more
Mild chest pains throughout the day after the vaccine shot. Went away the following morning. No other adverse side effects except for a sore arm. No side effects upon second dose on 4/19/2021
38 2021-06-02 tingling, burning sensation On day 2 or 3 of getting the shot, I started feeling a burning sensation in my chest and what felt l... Read more
On day 2 or 3 of getting the shot, I started feeling a burning sensation in my chest and what felt like my heart. It was about 3 or 4 out of 10 on the pain scale. I also had intermittent tingling sensations, mostly on my cheek to the left of my nose, but also tingling in locations around my body which happened only a couple of times. My heart beat rapidly. It was similar to the heart palpitations I get when I eat certain foods. It also felt as if my heart was constrained, as if its outer layers were less flexible than usual. When the symptoms showed up I started following a fairly aggressive anti-inflammatory diet, mainly wheat/cereal and Advil. I spent most of the time lying in bed facing up, in order to minimize strain on my heart. I had trouble laying on my side, since my chest/heart was sensitive to pressure. I also believe I was more acutely aware of the distribution of blood throughout my body, and laying on my side felt similar to being upside down in that blood was pooling heavily at the bottom, but I may be misremembering the sensation. I don't know if I had shortness of breath, since I took care to avoid exertion. Since my heart was beating like crazy, exertion of any kind seemed like a really bad idea. The symptoms did not change in severity for a couple days. On day 4 or 5 of getting the shot, I felt slightly feverish for about a 10 minute period. During this time, I noticed the burning sensation weakening slightly, and I began feeling a soreness on my chest near my left shoulder, which I believe is a lymph node area. Each day after, the symptoms and my heart calmed down little by little. ---- On day 9, I went to the emergency room since I still had heart palpitations and the burning sensation at about a 1/10 pain level. Just sitting upright caused my heart to go into overdrive. The hospital did not find anything out of the ordinary. I was given MAALOX, but the burning sensation was too faint to know if there was any improvement as a result. Their best theory is that I had costochondritis. ---- On day 11, after eating dinner I started getting "chronic hiccups". These last anywhere from 10 minutes to a couple of hours without stopping. I am not sure whether food or drinks cause them. They are short/acute hiccups and happen at an interval of about 10-15 seconds. I have no history of such a thing. ---- Today is day 12. The symptoms are noticeably better since I visited the hospital, but the burning sensation is still present around what feels like my heart and the hiccups aren't stopping. My best theory is that I may have had an infection by the time I got the vaccine. Maybe I had an infection, not necessarily COVID but some related virus, that was kept in check below an immune response threshold until the vaccine came along and led to the immune system burning the whole infection down.
38 2021-06-02 tingling Patient states having tingling sensation between cheekbone and ocular orbit bilaterally 30 minutes f... Read more
Patient states having tingling sensation between cheekbone and ocular orbit bilaterally 30 minutes following first dose of Pfizer covid-19 vaccine, lasting 1-1.5 hours
38 2021-06-06 pain in extremity Have had evolving symptoms over the past two months since vaccine. Starting with Tinnitus, fullness... Read more
Have had evolving symptoms over the past two months since vaccine. Starting with Tinnitus, fullness in ear, eye issues (feels off, potential lag). About a month in, pressure in nose, which goes through to tops of teeth came on. Soon after, started feeling other neurological symptoms, including pain in hands, wrist, forearms and right foot. Symptoms seem to come in waves.
38 2021-06-07 pain in extremity Swollen injection site after 12hours.. sore arm since april 8..
38 2021-06-08 pain in extremity mild headache; left arm soreness; This is a spontaneous report from a non-contactable consumer (Pati... Read more
mild headache; left arm soreness; This is a spontaneous report from a non-contactable consumer (Patients brother). A 38-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on an unspecified date as single dose for Cvoid-19 immunisation. He was administered his first vaccination of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE on an unspecified date with no AE. Medical history and concomitant medications were not reported. After vaccination, the patient experienced mild headache and left arm soreness on an unspecified date in second day after taking second dose. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
38 2021-06-10 flushing, unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
38 2021-06-10 numbness Transient left-sided headache and LUE/LLE numbness lasting for 1 day after COVID vaccine administrat... Read more
Transient left-sided headache and LUE/LLE numbness lasting for 1 day after COVID vaccine administration (Pfizer)
38 2021-06-13 electric shock sensation, numbness, tingling Numbness and tingling at my sides below the ribs and above the hips. Numbness and tingling across m... Read more
Numbness and tingling at my sides below the ribs and above the hips. Numbness and tingling across my torso in a horizontal line. I can feel the nerve as if it's an electric fence. It's a solid wire.
38 2021-06-13 migraine, depressed level of consciousness Severe Headache (Migraine) lasting more than 4 days, Body Soreness to injection site area lasting mo... Read more
Severe Headache (Migraine) lasting more than 4 days, Body Soreness to injection site area lasting more than 4 days, Fever of 101.3 for more than 8 hours, Large Knot at injection site lasting more than 4 days, Soreness and tenderness to arm after 4 days, Groggy and Cloudy head feeling, nausea with loss of appetite.
38 2021-06-13 pain in extremity, numbness, burning sensation, muscle spasms, nerve pain, numbness and pain in extremities, tingling, paralysis, seizure like phenomena, sensory loss 4/18/21 pfizer shot in left arm. 8 hours later nausea, heart race, dizzy. go to sleep. wake normal. ... Read more
4/18/21 pfizer shot in left arm. 8 hours later nausea, heart race, dizzy. go to sleep. wake normal. no more symptoms for 10 days. Day 10, arm pain returns at the injection site. Day 20 arm pain has spread in size and pain, i cancel the second shot. elbow and wrist become inflamed, tight, pain restricted. become sick for 5 days, headaches exhausted. prescribed 40mg prednisone for 5 days. first day it took the swelling down, then swelling came right back 2nd day. pinky and ring finder go numb, paresthesia/paresis. nerve pain in forearm to hand. ulnar nerve at first then all fingers. arm injection pain throbbing. rash shows up on stomach (now at 3.5 to 4 weeks since shot) cannot grasp a cup, weakness and numbness in hand. At this time its confined to the injection arm. Over the next week nerve pain and numbness spread to left side of face, both arms, hands, fingers, legs, feet, toes. physical therapist confirms elbow lymph node on injection arm swelling, hands turning red extreme pain and swelling, loss of feeling. nerve pain in the entire body, nerve and muscle spasms in all parts of body. Fingers and does burning at the tips feel like a string is cutting off circulation. Visibly red. Around the 4 week mark, fully unable to lift legs or arms, left half of face numb, zap/jots seizure like hitting my body. go to ER seemingly becoming paralyzed, within hours strength of legs returns but with numb feet/toes. no diagnosis other than peripheral neuropathy. neck begins to swell, hurts to swallow, throat closing. trying to sleep, throat closed, wake up, completely unable to open throat cant breath. throat episodes lasted about 5 days and resolved. complete insomnia and 24/7tinitus. any attempt to sleep or become tired results in heavy body zaps like hooked to a tenz unit. can't use hands or type, arm to hand seized nerves, feel like shrunken or contracted nerves. PCP prescribes benzos to sleep. this allows some sleep with waking every hour. over the following weeks symptoms seem to improve slowly but still debilitating. today at week 8+ since one shot only, I am able to type again, but with nerve pain and numbness in all fingers. loud tinnitus, numbness in all limbs, episodes of extreme debilitating muscle fatigue come in waves, almost unable to stand agonizing muscle fatigue and nerve zapping. These full body muscle episodes only seem to come in waves of 24 hours, then seem to feel recovering, only to relapse again. injection site pain seems to have wrapped around to the bicep 24/7 pain. unsure if this is nerve or muscle. 3 ER visits, PCP visits, blood tests, no help. I cannot work, constant nerve firing muscle spasms and nerve pain and episodes of weakness so bad you cannot sit without agonizing pain. I am disabled from this and still searching for help
38 2021-06-15 cold sweat, inability to speak consistent: brain fog, muscle aches, joint pain, headaches, difficult in concentration, losing words... Read more
consistent: brain fog, muscle aches, joint pain, headaches, difficult in concentration, losing words and tongue tied. poor and restless sleep. sporadic : cold sweats, neck stiffness, chest tightness, fevers.
38 2021-06-15 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Detai... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted 10 minutes after vaccine adminstration. patient was placed in a prone position and legs elevated. patient regained consciousness after 5 seconds, and was observed for another 30 minutes.
38 2021-06-16 muscle twitching My inner core began to feel as though it was shaking or pulsing, but no visible shaking on outside o... Read more
My inner core began to feel as though it was shaking or pulsing, but no visible shaking on outside of body. It is an odd sensation I have never felt before. This has persisted daily and spread to legs and chest. Primarily, the sensation is felt when laying in bed, or when still. Also note: After first dose, within minutes, I began to have a metallic taste in my mouth that continued for about 5 days.
38 2021-06-16 pain in extremity, tenderness Upper arm is extremely tender; Upper arm is extremely painful; cannot lift it above shoulder height ... Read more
Upper arm is extremely tender; Upper arm is extremely painful; cannot lift it above shoulder height due to pain; This is a spontaneous report from a contactable consumer (patient). A 38-years-old male patient received first dose of bnt162b2 (Pfizer BioNTech, formulation: solution for injection, Lot Number: EW0167), via an unspecified route of administration, administered in right arm on 20May2021 11:30 (at the age of 38-years-old) as single dose for COVID-19 immunisation. Medical history included ongoing SSRI discontinuation syndrome which would come back whenever he was sick and apparently also from the vaccine and ongoing electric brain zaps when he would get sick or have a temperature ever since he was a child and was taken off of paroxetine cold turkey which induced electric brain zaps and they went away at that time but continued having them lifelong whenever he would get sick, and also in response to this vaccine which felt like a jolt of electricity in the brain. The patient had no other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient was not COVID tested post vaccination. The patient had no known allergies. Concomitant medications included lorazepam; diazepam; paroxetine and bisoprolol. The patient previously took paroxetine. On 21May2021 at 01:00, the patient experienced upper arm was extremely tender, painful and could not lift it above shoulder height due to pain. It was unknown if the patient received treatment for the events. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
38 2021-06-20 muscle spasms, tingling, numbness, muscle twitching 1st covid shot: 10 minutes after I felt light headed and numbness\tingles throughout my entire body ... Read more
1st covid shot: 10 minutes after I felt light headed and numbness\tingles throughout my entire body for up to a minute. (didn't eat prior) 2nd covid shot: felt similar symptoms but only lasted a few seconds. (ate that day) ------------------------------------------------ Issues\Symptoms Week 1 May 2-8 Right eye started slowly watering on Sunday and kept going for a week Dizzy moment on a trip. Eye stopped watering mostly by Saturday ----------------------------------- Week 2 Dizzy moment again at a friend's house(hadn't eaten that day). Numbness through arms/weakness. May 10th: Panic attack. I was driving home and felt the numbness go through my arms so I pulled off and called friends to come and get me and take me home. Ended up calling another firend who is a nurse and she had me squeeze someone's hand and check my face for sign of a stroke etc. She thought I was having a panic attack and said to get some food, take some melatonin and try to calm down and goto sleep which I did. May 11th: Saw General doc who ordered blood work and heart monitor. No recommendations for immediate issue. EKG looked fine. Through the week Numbness and tingles in arms and head Ringing in ears, lots of head/sinus pressure, unable to focus, brain fog. ----------------------------- Week 3 May 19th: Had blood drawn for testing: Night before getting heart monitor I couldn't sleep because it felt like not breathing fast enough made me light headed to the point I could pass out and was getting worried. May 20th: Fitted with a heart monitor for 48 hours. I was freaking out when we got to the hospital and almost went to the ER but we went to cardiology and saw the nurse who helped calm me down and did another EKG which looked good. Blood pressure was high that day possibly from the anxiety. Stayed at my dad's the next few days with the monitor, had tingles a couple times, some pressure, but slept well. ------------------------------ Week 4 May 24th: Followup with General doc said blood tests looked good, not diebetic, blood pressure fine, no signs of heart problems. Gave me 6 days of prednisone and Nasonex for possible inflammation of Eustachian tube. (didn't feel like they helped any) through the week: Felt okish for a day and a half, drove to work and then towards the end of the day started feeling off, right side feels like it's floating up and down, sensation down through leg which lasted about a week. Pushed in between nose and cheek on right side and felt numbness/pain shoot through my head on that side Periods of ringing again though not as much but also periods of head pressure and pain if resting head on hands etc. --------------------------- Week 5 Muscle spasms in both arms lasting a couple minutes, finger twitching on left hand. Also had muscle spasms in legs since. ENT visit June 2nd: Audiologist tested hearing and saw no issues. ENT gave me an exam and did not find any issues with the Eustachian tube or any other problems. Suggested to do see if the symptoms continue to lessen and if they dont then do a VNG test and if that doesn't provide anything that he would have to refer me to a Neurologist next to see if they can find anything. After the visit I came upon a web site and found that there are 300 pages of other people posting having the same symptoms as I have been experiencing for varying lengths of time, some upwards of 10 weeks. https://vestibular.org/forum/dizziness/covid-19-vaccine-side-effects/ At this point I am absolutely convinced my issues have been as a result of some sort of reaction from the covid vaccine. There are way too many people having the same issues in a similar timeframe for not to be true. In the few weeks since I still have symptoms that come and go but don't last nearly as long when they do. However it can still be quite disruptive depending on the circumstance.
38 2021-06-24 pain in extremity Significant pain in the injected arm; muscle ache; general malaise; Fatigue; flu/cold like symptoms;... Read more
Significant pain in the injected arm; muscle ache; general malaise; Fatigue; flu/cold like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 38-year old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 18Mar2021 at 10:45 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported and the patient had no known allergies. 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 23Feb2021 at 10:00 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 08:00, patient experienced significant pain in the injected arm, muscle aches, general malaise, fatigue, and flu/cold like symptoms. No drugs were taken for the treatment of significant pain in the injected arm, muscle aches, general malaise, fatigue, and flu/cold like symptoms. The clinical outcome of pain in arm, muscle aches, general malaise, fatigue, and flu like symptoms was recovering at time of this report. No follow-up attempts are needed. No further information is expected.
38 2021-06-24 pain in extremity Had arm pain for three days; This is a spontaneous report from a contactable consumer (patient) from... Read more
Had arm pain for three days; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program COVAX US support. A 38-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0175, expiry date: 31Aug2021) via unspecified route of administration, administered in right side upper arm on 20May2021 (08:05 AM may be, he clearly didn't remember) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no family medical history. Patient did not receive prior vaccination (4 weeks prior). In May2021, after the first dose patient had arm pain for about three days. Patient did not received treatment. The outcome of event was resolved in May2021. Information on lot/batch number was available. Additional information has been requested.
38 2021-06-27 hot flush, weakness 3 hours after 2nd Pfizer dose my body was profusely sweating. I developed a terrible headache and pr... Read more
3 hours after 2nd Pfizer dose my body was profusely sweating. I developed a terrible headache and pressure in my head, along with mild fever, body aches, nausea, hot flushes, brain fog, dizziness and temperature deregulation. After 4 days in bed, the fever subsided and the symptoms got a little better. However, the headaches, brain fog, dizziness, nausea, hot flushes and extreme fatigue persisted. I thought these symptoms would go away in a day or so, but they have persisted for over 2 months now. I have been to the doctor multiple times, she ordered pcr tests to rule out covid and multiple blood tests. Doctor thinks I have a form of long covid syndrome, but triggered by the spike protein rather than the virus itself. The most debilitating thing has been the extreme fatigue and brain pressure and brain fog / cognitive slowness. It has prevented me from working and made my life a living hell. I would have to lie down and be in bed after something so simple as going to the grocery store. In the last week symptoms have improved a little, but still the headaches, head pressure, light headedness and fatigue remain as of today June 28th 2021.
38 2021-06-30 burning sensation I had a severe shingles outbreak which I believe wasrelated to Pfi zer covid vaccine. I had 3 quite ... Read more
I had a severe shingles outbreak which I believe wasrelated to Pfi zer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. Inaddition, I had severe headaches for several days. I'm 38 and I've never had shingles before (although I likelyhad chickenpox in my childhood). An urgent care nurse prescribed me Acyclovir 800MG tablets 5 times a dayand TRIAMCINOLONE 0.1% cream 2-4 times a day. Now 2 weeks later the rash looks much better however Istill feel annoying burning.
38 2021-06-30 pain in extremity My arm is hard, swollen and tender and it's not getting any better; My arm is hard, swollen and tend... Read more
My arm is hard, swollen and tender and it's not getting any better; My arm is hard, swollen and tender and it's not getting any better; My arm is hard, swollen and tender and it's not getting any better; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 38-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0187) via an unspecified route of administration on 17Jun2021 at 16:00 (age at vaccination 38years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient did not take any other medical condition. The patient did not take any other vaccine after covid vaccine. The patient previously received BNT162B2 dose 1 on 27May2021 16:00 AM (at 38 years of age) (Batch/Lot number: EW0185) via unspecified route of administration for COVID-19 immunisation. The patient experienced arm was hard, swollen, and tender and it was not getting any better on 18Jun2021. The patient did not receive any treatment for the events. The clinical outcome of the event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
38 2021-06-30 trigeminal neuralgia After second shot I felt spark in my head for 2-3 days. It disappeared. But I am feeling spark again... Read more
After second shot I felt spark in my head for 2-3 days. It disappeared. But I am feeling spark again since 2-3 days and it?s more worse than before.
38 2021-07-04 slurring, tingling, night sweats Fatigue, brain fog, emotional control, nausea, constant bronchitis type cough, pain, strange feeling... Read more
Fatigue, brain fog, emotional control, nausea, constant bronchitis type cough, pain, strange feelings in head, tingles rapid onset loss of focus, speech slowing sluring, profuse soaking night sweat.
38 2021-07-05 flushing, weakness, tremor, tingling Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Nausea-Severe, Systemi... Read more
Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Patient came out of vaccine area to wait for 15 minutes to be monitored when he started sweating profusely, was pale white and asked for someone to come talk to him. After reviewing potential adverse effects, patient was able to breathe, no swelling or trouble breathing. But complained of arm tingling/dizziness/weakness at which point rescue squad was dispatched for further evaluation. I stayed with patient and reviewed symptoms with rescue squad, patient choose not to go with rescue squad.
38 2021-07-05 tingling Chest tightness, muscle weakness, overall fatigue, dizziness, joint pain, chills, shortness of breat... Read more
Chest tightness, muscle weakness, overall fatigue, dizziness, joint pain, chills, shortness of breath, tingling feeling in hands and feet. Symptoms kept getting worse for about 3 weeks. Was hospitalized to make sure nothing wrong with heart. Heart checked out OK. Blood tests came back clean for any other diseases. Symptoms lasted for 4 more weeks getting gradually better with time.
38 2021-07-07 weakness Woke up the day after the vaccine with tightness in chest and experienced extremem weakness
38 2021-07-08 bell's palsy Left sided Bells Palsy which began 3 days after vaccination. Has been treated with prednisone and va... Read more
Left sided Bells Palsy which began 3 days after vaccination. Has been treated with prednisone and valacyclovir.
38 2021-07-09 weakness WEAKNESS, TIRED
38 2021-07-13 tenderness Patient received 2nd dose of Pfizer Covid vaccine on 07-12-21 at 0930. Presented to Health Dept on 0... Read more
Patient received 2nd dose of Pfizer Covid vaccine on 07-12-21 at 0930. Presented to Health Dept on 07-13-21 and reported that he noticed his left axcillary area was swollen around 0830 on the morning of 07-13-21 approximately 24 hours after receiving 2nd dose of Covid vaccine. Nurse noted that left axcillary area was swollen on the inner area closest to chest and directly in the arm pit area. No erythema present on 07-13-21, was slightly tender to touch. Encouraged to use anti-inflammatory meds, watch area, and to seek medical attention if symptoms persisted or becomes worse.
38 2021-07-14 seizure, pain in extremity /14 12:10pm - received first shot 7/15 3:45am - started having extreme nausea and have had sore arm... Read more
/14 12:10pm - received first shot 7/15 3:45am - started having extreme nausea and have had sore arm since receiving shot 7/15 4:00am - started having extreme uncontrollable chills / convulsions. Almost couldn?t walk or hold object in hand they were so bad. Also had back ache 7/15 4:20am - chills started to subside 7/15 4:45am - chills and nausea almost gone 7/15 8:00am - stomach cramps 7/15 9:00am - vomiting 7/15 9:00pm - vomiting Severe diarrhea at least 6 times on 7/15 Constant stomach cramps still occurring
38 2021-07-16 flushing, unresponsive to stimuli, weakness, tremor Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild,... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient has panic attacks from all medical procedures even blood pressure readings at the MD office. He felt faint and asked to lay down. Patient did not want intervention due to his deep fear and dread of medical facilities in general. Wife said this happens and if I would step away she would monitor and get us if needed. To respect patients wishes we put a fan on him while he laid on the floor with a pillow and wife gave him some electrolyte fluids by mouth.Better within 30min left on own will
38 2021-07-17 pain in extremity Chills; Chest pressure was noticeable when he was about to go to sleep; He had a hard time sleeping ... Read more
Chills; Chest pressure was noticeable when he was about to go to sleep; He had a hard time sleeping because of it.; Lightheadedness; A sharp shooting chest pain afterwards; A sore arm/Soreness in left arm; This is a spontaneous report from a contactable consumer (patient) reported that. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 16:30 (age at vaccination 38-year-old) (Batch/Lot number was not reported) as dose 1 single for covid-19 immunization. The patient past Medical history included asthma (has been diagnosed for a couple of months but has had this his whole life),gastroesophageal reflux disease (Additional Information for Other Conditions: caller has been diagnosed for a couple of months but has had this his whole life , death of relative). Concomitant medication included pantoprazole taken for gastroesophageal reflux disease and Albuterol [SALBUTAMOL] for asthma. Patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 04May2021, the patient experienced lightheadedness there was an initial rush right when he got the shot. It subsided and he stayed for 45 minutes and then he felt fine. Then, it came back when he got ready for bed. He is still having it today and he also had chest pain and thought it was from the soreness from his arm, but it is not going away. On an unspecified date the chest pressure was noticeable when he was about to go to sleep. There are still traces of the chest pain. The chest pain was yesterday but was not severe until the evening. It has gotten better and Last night it was was rough. The left arm, soreness is still there like someone hit him with a baseball bat. He wants to know what is normal for side effects of the vaccine, because he knows that like fever and stuff are. He did research online and was not finding much on this. He knew his arm would hurt. The patient is treated for the pain on the arm he took 200 mg Ibuprofen before bed. He has taken a multivitamin this morning. The event outcome was not recovered for a sore arm/Soreness in left arm, chest pain and lightheadedness and for rest of the event was Unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
38 2021-07-17 pain in extremity Arthritis; I was still in some pain; The pain then went to my big toe (very severe); I still have so... Read more
Arthritis; I was still in some pain; The pain then went to my big toe (very severe); I still have some pain in my ankle; I think it was gout; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 02Jun2021 (at the age of 38 years-old) as dose 2, single for covid-19 immunisation. The patient 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, was the patient did not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), on unspecified date in 2021 (at the age of 38-yesr-old) via unknown route for COVID-19 immunisation and experienced arthralgia. Reporter stated between vaccine 1st and 2nd, On 27Jun2021, patient started feeling pain in his right ankle, which turned into severe pain. Patient went to urgent care 2 days after his second vaccine. First, they told him it was arthritis. He went back 12 days later because he was still in some pain. They ran no further tests. The pain then went to his big toe (very severe) which lasted about 2 weeks, but he still have some pain in his ankle. Patinet think it was gout, possible brought on by the vaccine. Patient visited Emergency room/department or urgent care. Treatment was received for the events as Steroids. The outcome of the events was reported as recovering. Information on the lot/batch number has been requested.
38 2021-07-17 tingling, facial paralysis Partial paralysis of face, tingling in cheek of face
38 2021-07-18 mild one side paralysis Ever since my second COVID-19 shot, my left arm has felt "weak" and has varying levels of discomfort... Read more
Ever since my second COVID-19 shot, my left arm has felt "weak" and has varying levels of discomfort when idle. The discomfort is near the injection site. I had both shots done in the same arm/site. Doctor prescribed me a topical NSAID painkiller to apply, which didn't seem to make much difference.
38 2021-07-18 tenderness, pain in extremity, tingling Synopsis of event from ED and attending physician documentation, and pt. interview by this nurse: ..... Read more
Synopsis of event from ED and attending physician documentation, and pt. interview by this nurse: ...not feeling well for two days with dyspnea on exertion, fatigue, palpitations and mild body aching. Denies any chest pain, shortness of breath at rest or pleuritic pain, noticed lump over anterior right lower leg. Denies hx of leg swelling, calf or thigh pain, no recent travel by air or car. Received first COVID-19 vaccine 7/15/2021. States Friday, 7/16/2021 had 'pins and needles' sensation anterior lower leg then developed lump in that area, painful to touch, slightly reddened. Hx of torn fascia in area per pt. Denies fever, no nausea, vomiting or diarrhea.
38 2021-07-19 seizure Male 38. With no other disease. With no epilepsy in history. Convulsions most probably secondary TO... Read more
Male 38. With no other disease. With no epilepsy in history. Convulsions most probably secondary TO COVID VACCINATION
38 2021-07-20 tingling, burning sensation, mild one side paralysis Several episodes of facial burning and tingling. Bilateral eye burning. R sided weakness, headache a... Read more
Several episodes of facial burning and tingling. Bilateral eye burning. R sided weakness, headache and dizziness. Several episodes from 7/19-7/21. Was determined to have an acute ischemic stroke. Given heparin, phenylephrine, aspirin, clopidogrel, and eventually underwent embolectomy today. Still hospitalized.
38 2021-07-21 numbness Dizziness, fatigue, blood in Urine, Chest and Stomach burning, joint pain, irregular heartbeat and n... Read more
Dizziness, fatigue, blood in Urine, Chest and Stomach burning, joint pain, irregular heartbeat and numbness on both the hands Blood test - Normal ECG - Normal Echo - Normal Cardio Monitor (72 Hrs) - Normal Blood in Urine - It was normal after 15 days. Taking Meclizine 25 MG for dizziness.
38 2021-07-21 pain in extremity, weakness I experienced pain in my left arm/shoulder. I went to my PCP, He had me do exercises at home to help... Read more
I experienced pain in my left arm/shoulder. I went to my PCP, He had me do exercises at home to help my shoulder but it did not help anything. The pain is still in my arm and has not gone away. It has affected my strength and my range of motion.
38 2021-07-22 facial paralysis, numbness, weakness After 1st shot, I had a racing heart rate and I felt my heart beating hard in my chest. I was not i... Read more
After 1st shot, I had a racing heart rate and I felt my heart beating hard in my chest. I was not informed that this in and of itself was cause for concern or mention. It was not on the 1st shot warning sheet. This continued for about 30 to 1 hour and subsided. I figured it was me being anxious and dismissed it. After the 2nd shot, my heart did not race immediately. 10 minutes into the shot, I had sensations of what I can best describe as fiberglass being rubbed into the skin of my body at random intervals. This lasted until I took a zyrtec when I got home about 1.5hrs after the shot. On my drive home, approximately 25 minutes after the shot my right face went numb and I could not move the right side face muscles. I monitored my face for drooping for the remainder of the drive and had called my mother to have someone on the phone 'just in case'. This numbness and frozen muscle control lasted approximately 3 hours. The following day I experienced intense flu-like symptoms with a mild fever, extreme body fatigue, and zero energy. This lasted 2 days. 3 days after the shot the body fatigue subsisted. My heart felt like was constantly racing, and if I tried to exert myself my heart would pound in my chest. I would manage these symptoms by managing my activity levels. Finally, 2 weeks nearly to the day, on 7/22 I was working (as a massage therapist) and even standing still or sitting while working on a client I was getting light headed on top of the heart racing and pounding described above. I took myself to the urgent care facility mentioned in item 19. Today, 7/23 the symptoms are still as present as they were yesterday .
38 2021-07-26 muscle spasms Three hours after injection, my bottom lip started to have muscle spasms. They are still occuring at... Read more
Three hours after injection, my bottom lip started to have muscle spasms. They are still occuring at a rate of about 20 per day and last anywhere from 3 to 10 seconds.
38 2021-07-26 tremor, seizure During the week he complianed about chest pain, but we didn't pay any attention. On Saturday morning... Read more
During the week he complianed about chest pain, but we didn't pay any attention. On Saturday morning he was ok, went out and when he cema back he laid down. In the afternoon i woke him up and he had a fever of 102.2, blood pressure 157/96, he was shaking and desoriented. I called 911, in the ER he continue like tat. The doctor did some labs and came out negative, everything they did came out negative, he has seazures the next day and was sent to ICU. He was intubated for 4 days. The doctors said that it was a brain infection but all the test results are negative. The doctors at first thought that it was either menigitis or encephalitis, all the test were negative . His final diagnosis was Sepsis, unspecified organism. He still recovering and does not have any recolection of what happened to him.
38 2021-07-27 inability to speak Since the second injection I've lost the ability to speak. Along with quite a lot of pain in my thro... Read more
Since the second injection I've lost the ability to speak. Along with quite a lot of pain in my throat. As I'm not a doctor I couldn't say if it is vaccine related, but one thing followed the other.
38 2021-07-27 weakness Body pains; Chills/ shivering; Feeling a little weak; Fever; Wasn't able to sleep; Severe headache; ... Read more
Body pains; Chills/ shivering; Feeling a little weak; Fever; Wasn't able to sleep; Severe headache; Even when you touch his body it hurts. Patient added especially his shoulder where he took the vaccine; This is a spontaneous report from a contactable consumer. This 38-year-old male consumer (patient) reported that: A 38-years-old male patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0179), via an unspecified route of administration, administered in right of his shoulder on 19May2021 at 06:00 as single dose (at the age of 38-years-old) for covid-19 immunisation. Medical history was none. Family history included Mom and Dad have blood pressure and diabetes. Patient mom has this eye issue, glaucoma. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 (Solution injection; Batch/Lot Number: FW0179), via an unspecified route of administration, administered in left of his shoulder on 27Apr2021 at 05 20 as single dose (at the age of 38-years-old) for covid-19 immunisation. Patient did not take any other vaccine prior to the first administration of the suspect vaccine. The patient experienced shivering and all that along with body pains. Even when you touch his body it hurts. Patient added especially his shoulder where he took the vaccine. Patient reported that he drove home after the shot. He was at home for about 45 minutes. After 4-5 hours he was feeling a little weak, thought it was normal. Within 3-4 hours of time, he was having a fever, he knew it was normal, and he went to bed around 9pm. He thought he was feeling cold. He got a blanket to cover his body. Was feeling a little warm, when he took the blanket off he was feeling cold. Since then, he couldn't even close his eyes to sleep, was having pain all over his body. When he shakes his head there was pain all over his head. He had a severe headache, so last night he took Tylenol to try to see if he can bring the pain down. It helped a little bit, but he woke up this morning still feeling the same. He couldn't sleep because of the pain. When he touched his shoulder where the vaccine was given, it was very painful. He could not sleep the whole last night. Later, he was a little bit ok. It was a little bit improved. He was not shivering anymore, but the AC was off and he put fan on low mode. He reported that even now he wants to go to sleep but when he laid down, he moves from the left to the right, and had pains all over his body. He wishes he could sleep, but he can't. He stated that he had not taken his temperature, but stated he still having a fever today. He took tylenol for headache which helped a little bit but still has it today. Patient stated that his wife took his temperature, and it was 177/108. Clarified with patient that his wife checked his blood pressure. It was a wrist cuff. Pulse was 78. Therapeutic measures were taken as a result of body pains and severe headache. The clinical outcome of the chills and insomnia was unknown while the outcome of all the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
39 2020-12-31 migraine Headache and myalgias started day 2 after vaccine, treated with ibuprofen and APAP turned into: Migr... Read more
Headache and myalgias started day 2 after vaccine, treated with ibuprofen and APAP turned into: Migraine headache started 8 days after vaccine, lasted 2 days and treated with sumatriptan led into: Shingles on left side of face started after migraine
39 2021-01-01 cold sweat Patient became lightheaded, clammy and passed out (typical vagal reaction). Patient aroused easily,... Read more
Patient became lightheaded, clammy and passed out (typical vagal reaction). Patient aroused easily, VS monitored.... patient was able to sit up after about 5 minutes. Monitored for 30 minutes post vaccination. Patient did not need any other intervention or care.
39 2021-01-03 burning sensation, numbness, tingling guillain barre syndrome; stroke; left thigh burning; Left b/l gluteal burning/bilateral gluteal burn... Read more
guillain barre syndrome; stroke; left thigh burning; Left b/l gluteal burning/bilateral gluteal burning; paresthesia; mid back burning; right side burning / right thigh burning; b/l hand numbness/bilateral hand numbness; left facial numbness; b/l foot numbness/bilateral foot numbness; This is a spontaneous report from a contactable physician (patient). A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 19Dec2020 at single dose for prevention. Medical history included none. There were no concomitant medications. Caller states, he received the covid vaccine 19Dec2020 and on 25Dec2020 he was experiencing left facial numbness, b/l foot numbness, b/l hand numbness on 26Dec2020, right side burning on 28Dec2020, Today (29Dec2020) he has had left thigh burning, and Left b/l gluteal burning and paresthesia. No motor issues and no tendon issues, all intact. Also had mid back burning on 28Dec2020 that comes and goes. He has heard that there is a described neuropathy with the virus and/or with the vaccine and wants more information on that. Curious if anyone has anything similar? and makes mention of possible Gillian Barre Syndrome. States that he has had a potential reaction. He had his dose on 19Dec2020. On 25Dec2020 he developed left facial numbness, then later that day he developed bilateral foot numbness. On 26Dec2020, he developed bilateral hand numbness, on 28Dec2020 he developed right thigh burning, and today (29Dec2020) he has developed left thigh burning, and bilateral gluteal burning and paresthesia. States that he has been kind of freaking out about it. He doesn't have any motor issues. States that he heard that there is a described neuropathy with the virus, but not with the vaccine, is that true? The left facial numbness resolved on either 26Dec2020 or 27Dec2020. States that the symptoms were concerning because it could have been a stroke. States his symptoms were moderate. States that due to the bilateral foot and hand numbness, he had a LP, brain and spine MRI, and blood work done on 26Dec2020. All came back completely normal. When asked about causality, caller states that it makes the most sense for his symptoms to be caused by the vaccine due to his age and the fact that all his testing was completely normal. Reporter seriousness for left facial numbness, bilateral foot numbness, bilateral hand numbness, right thigh burning, left thigh burning and bilateral gluteal burning and paresthesia: Medically significant. The outcome of the event left facial numbness was recovered in Dec2020. The outcome of the events guillain barre syndrome, stroke and mid back burning was unknown. The outcome of the other events was not recovered.; Sender's Comments: Based on the temporal relationship the association between the reported serious adverse events 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.
39 2021-01-03 flushing Approximately 30 minutes after the injection I felt myself get very flushed and slightly lightheaded... Read more
Approximately 30 minutes after the injection I felt myself get very flushed and slightly lightheaded. This feeling lasted for about 45 minutes before resolving. Had right shoulder pain start about 1-2 hours after the vaccine and it steadily increased to the point where it was too painful to move in certain ways that utilized that muscle. I had to assist my right arm with my left when needing to move it in certain ways between 12-36 hours after the vaccine was received. The pain dissipated to manageable levels after 48 hours post vaccination and resolved completely after about a week. Also experienced significant fatigue that started 3-4 hours after the vaccination. the first night after the vaccination I slept for 12 hours and the second night I slept for 10 hours. I was still able to go to work which does not involve too much labor and alot of computer work. Once home I did essentially nothing except rest on the couch or in bed. When I woke up on the third day the fatigue was mostly gone. It was completely resolved on the 4th day.
39 2021-01-03 pain in extremity I had a persistent headache on day 1 after the vaccination. Also, had severe fatigue and later that ... Read more
I had a persistent headache on day 1 after the vaccination. Also, had severe fatigue and later that day I had chills with severe myalgia that lasted 48 hours requiring to take Ibuprofen for 2 days. The sourness in my left arm was more pronounced that with any other vaccine.
39 2021-01-04 weakness Weakness on the first day Diarrhea, weakness, chills, and weight loss the day after and ever since
39 2021-01-05 weakness Fever, chills, myalgias, arthralgias, weakness, nightmares.
39 2021-01-06 tenderness Swelling under my armpit.....black and blue....tender to touch...noticeably different than my right ... Read more
Swelling under my armpit.....black and blue....tender to touch...noticeably different than my right armpit in terms of swelling
39 2021-01-09 night sweats Night of the shot I had night sweats and chills. Woke up the following morning with 100 deg temperat... Read more
Night of the shot I had night sweats and chills. Woke up the following morning with 100 deg temperature. Experienced body aches. Temperature went away 2 days after vaccine.
39 2021-01-10 tingling Followed by neurological symptoms staring day 4; parasthesias of both upper extremity; progression t... Read more
Followed by neurological symptoms staring day 4; parasthesias of both upper extremity; progression to muscle weakness of all four extremities/Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop; progression to muscle weakness of all four extremities/Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop; Flu like symptoms first 3 days; This is a spontaneous report from a contactable physician (patient). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ek5730) at left arm, via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension, diabetes, migraines, Eosinophilic granulomatosis with polyangiitis (EGPA) remission. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 21Dec2020, the patient experienced flu like symptoms first 3 days. Followed by neurological symptoms staring day 4, parasthesias of both upper extremity with progression to muscle weakness of all four extremities. Leading to 2 ER visits and hospital admission. Evaluation by internal medicine, neurology and rheumatology. Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The treatment for events included High dose steroid. Covid test included Nasal Swab: negative on 19Dec2020. The outcome of events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events influenza like illness, neurological symptom, paraesthesia, muscular weakness and peroneal nerve palsy cannot be excluded. 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.
39 2021-01-11 pain in extremity R arm pain, fatigue, mild chills, wrist pain, insomnia
39 2021-01-11 tingling, numbness left V2 and V3 distribution numbness/bilateral foot numbness; bilateral entire lower extremity parae... Read more
left V2 and V3 distribution numbness/bilateral foot numbness; bilateral entire lower extremity paraesthesias; This is a spontaneous report from a contactable other hcp. A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. The patient had left V2 and V3 distribution numbness 6 days after vaccine which resolved in 2 days. The patient had bilateral foot numbness 7 days after vaccine which resolved approximately 5 days later. After the foot numbness, the patient had progressively increasing bilateral entire lower extremity paraesthesias since Dec2020 (resolved in 5 days). The patient never had any motor weakness, or delayed tendon reflexes. No other medical conditions. No cause identified on LP, MRI brain, C, T, and L spine, or labs. Presuming vaccine related given relative likelihood of other conditions on differential diagnosis, timing, and resolution. The outcome of the event left V2 and V3 distribution numbness was recovered on 27Dec2020, of the event bilateral foot numbness was recovered on 31Dec2020, of the event bilateral entire lower extremity paraesthesias was recovered on an unspecified date.
39 2021-01-12 coordination abnormal, pain in extremity, tingling, numbness severe stabbing-shooting lower back pain; severe stabbing-shooting lower back pain that radiated to ... Read more
severe stabbing-shooting lower back pain; severe stabbing-shooting lower back pain that radiated to both legs; Pricking, pins and needles sensations in the hands and feet; numbness; weakness to both legs but mostly the right leg; Coordination problems, unsteadiness; Coordination problems, unsteadiness; This is a spontaneous report from a contactable nurse (patient). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscular on 20Dec2020 08:00 at single dose at left arm for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications in two weeks included multivitamins. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. No known allergies to medications, food, or other products. On 22Dec2020 at approximately 19:15, the patient experienced sudden onset of severe stabbing-shooting lower back pain that radiated to both legs. Pricking, pins and needles sensations in the hands and feet. Coordination problems, unsteadiness, numbness, and weakness to both legs but mostly the right leg. The patient underwent lab tests and procedures post-vaccination which included nasal swab for covid test: negative on 30Dec2020 (Antigen Test). Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Patient received pain medication, steroid dose pack, MRI (pending), and physical therapy (pending) as treatment. Outcome of all events was not recovered.; Sender's Comments: Based on the compatible temporal association, a contributory role of vaccination with BNT162B2 in the onset 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.
39 2021-01-12 pain in extremity Sore arm; fatigue; headache; sore eyea; This is a spontaneous report from a contactable other HCP. A... Read more
Sore arm; fatigue; headache; sore eyea; This is a spontaneous report from a contactable other HCP. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at 06Jan2021 06:45AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. The facility type vaccine was hospital. The patient medical history was not reported. Concomitant medication included hydrochlorothiazide, losartan potassium (HYZAAR), ibuprofen, omeprazole. The patient previously took amoxicillin and experienced drug hypersensitivity. Patient received the first dose of BNT162B2 at 16Dec2020 12:45 PM left arm for covid-19 immunization, then on 22Dec2020, patient tested Nasal Swab, the result was positive. Patient was not diagnosed with COVID-19 prior to the first dose of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Sore arm, fatigue, headache, sore eyea on 07Jan2021 03:00 AM with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious. Information on the lot/batch number has been requested.
39 2021-01-13 tingling Tongue and lip numbness and tingling. Itchy on both arms Took Benadryl, resolved
39 2021-01-14 migraine Severe Migraine
39 2021-01-14 tingling In the left arm where I received my first dose of Covid-19 vaccine (Pfizer) I started getting a numb... Read more
In the left arm where I received my first dose of Covid-19 vaccine (Pfizer) I started getting a numbness feeling in the area of the injection. It feels very similar to when a limb falls asleep. There is numbness and tingling feeling . So far there is no pain or weakness. There has been no treatment. This started on 1/14/2021 and has continued through today.
39 2021-01-17 feeling cold, night sweats About an hour after receiving the second dose, I became severely lethargic and started having chills... Read more
About an hour after receiving the second dose, I became severely lethargic and started having chills. Symptoms lasted about 20 hours. Woke up and bed was completely saturated with sweat.
39 2021-01-18 hot flush approx 30 minutes after receiving the vaccine, client started c/o feeling facial heat and generalize... Read more
approx 30 minutes after receiving the vaccine, client started c/o feeling facial heat and generalized facial rash. He denies difficulty breathing, throat closure, or lip tingling and swelling.Client was given Benadryl 50mg Im to L Deltoid at 2:41pm. 3:00pm client reports feeling well. Wife 10-15 minutes away. He was released to his wife for her to drive him home. client reports to having a similar episode after an allergy shot 4-5 yrs ago. He was given Benadryl and prednisone.
39 2021-01-18 pain in extremity First Vaccine , did not have any reactions other than a sore arm. The second vaccine he started hav... Read more
First Vaccine , did not have any reactions other than a sore arm. The second vaccine he started having severe chills, body aches temp of 102F and pain at the injection site. He also had vomiting and dizziness for over 24 hours. He took two days off work but states he has resolved to normal at this time.
39 2021-01-19 weakness, hot flush Malaise, Chills, Hot-Flashes, Dizziness, Profound Weakness and Fatigue X 5 days. No fevers, No ... Read more
Malaise, Chills, Hot-Flashes, Dizziness, Profound Weakness and Fatigue X 5 days. No fevers, No dyspnea
39 2021-01-19 numbness Right axillary is sore, tender. Very painful. Numbness in right leg like it is asleep
39 2021-01-20 numbness "Pfizer-BioNTech COVID-19 Vaccine EUA" Pt with hx of herditary angioedema. About 10 minutes after g... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA" Pt with hx of herditary angioedema. About 10 minutes after getting vaccine, started to get thirsty. By 30 minutes patient started experiencing numbness and tingling in fingers, then the face, tongue, and lips started to swell. At that time patient took own supply of famotidine 10 mg, diphenhydramine 25 mg, and prednisone 20 mg. Symptoms resolved after about 45 minutes.
39 2021-01-21 feeling hot Woke up at 6:00am, felt hot, had to use the bathroom. Got up, went to the bathroom felt dizzy, I wa... Read more
Woke up at 6:00am, felt hot, had to use the bathroom. Got up, went to the bathroom felt dizzy, I was able to get to the floor before passing out/fainted. Felt chills when I finally went back, but could have been from how long I was laying on the floor.
39 2021-01-24 numbness On 1/8/21 redness and pain at the site of the administration of the vaccine. Numbness of the left ha... Read more
On 1/8/21 redness and pain at the site of the administration of the vaccine. Numbness of the left hand, tiredness and intermittent headache.
39 2021-01-24 muscle spasms Muscle spasms in same arm immediately after shot was given. Muscle spasms lasted a day and a half bu... Read more
Muscle spasms in same arm immediately after shot was given. Muscle spasms lasted a day and a half but have subsided. However now having muscle spasms in right leg.
39 2021-01-25 tingling Tingling in my fingers. Opposite side of body of injection. Shortness of breath. Fatigue.
39 2021-01-25 tenderness, pain in extremity Lymph node enlargement and tenderness on opposite arm, near elbow (epitrochlear)
39 2021-01-27 feeling hot, weakness At 1:00 pm on 1-25-2021 he stated he started feeling bad, bodyaches, headache, "sick feeling". That... Read more
At 1:00 pm on 1-25-2021 he stated he started feeling bad, bodyaches, headache, "sick feeling". That night fever started 99*, still ha bodyaches, headache, chills. On 1-26-2021 woke up with 101.7* temperature, took Tylenol 1000mg every 4-5 hours until it broke (approx 12 hours). On 1-27-2021 fever down to 99* most of the day, no energy, headaches, bodyaches, "feel like a mack truck hit me" also reports "I could felt every broken bone that I have had" "that spot just hurt". 1/28/2021 reports that he is feeling some better, no fever, but still feels very tired and sore. Sent home from work today and encouraged to drink fluids, take Tylenol and rest. Encouraged to talk to his PCP if symptoms continue to get worse.
39 2021-01-28 feeling hot This 39 yo civilian ctr reported being in good health 1/27/2021 when he received his 2nd Pfizer Covi... Read more
This 39 yo civilian ctr reported being in good health 1/27/2021 when he received his 2nd Pfizer Covid vaccination. He states about 3-4 hours after his vaccination (mid day) he felt "very hot" from head to chest, and his upper lip region under nose was red and sore. That evening he noticed small circular fluid filled blisters above left upper lip and below left lower lip in chin area. He began to treat with hydrogen peroxide and wipe with alcohol. This cased area to begin to dry and crust over. It's been 2 days and while drying out, these blisters are not increasing. He denies any fever, myalgia, arthralgia, n/v/d, or any other systemic symptoms. He denies any trauma to his lips/face, burns or recent illnesses. Patient request VAERS filed by clinic team.
39 2021-01-31 facial pain I developed pain on the left side of my face followed by a rash on my left side of face.
39 2021-02-01 pain in extremity redness, pain to right arm, hive like rash on right side of neck and right cheek 2 days after vaccin... Read more
redness, pain to right arm, hive like rash on right side of neck and right cheek 2 days after vaccination without dyspnea, angioedema, other rash location, nausea, lightheadedness. prescribed cetirizine and famotidine
39 2021-02-02 pain in extremity Minor headache and sore arm.
39 2021-02-03 fibromyalgia Triggered mild asthma attack; wheezing; Continued pain at injection site; Triggered a fibromyalgia e... Read more
Triggered mild asthma attack; wheezing; Continued pain at injection site; Triggered a fibromyalgia episode; body pains; headache; fatigue; dizziness; This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 19Jan2021 08:45 at single dose for COVID-19 immunisation. Medical history included fibromyalgia and asthma. On 19Jan2021 16:00, the patient experienced triggered mild asthma attack, wheezing, continued pain at injection site, triggered a fibromyalgia episode, body pains, headache, fatigue, and dizziness. No therapeutic measure was taken as a result of the events. Clinical outcome of injection site pain was not recovered while for the other events was recovered on Jan2021.
39 2021-02-03 night sweats, pain in extremity Left arm soreness progressively increasing now 18 hours after injection difficulty raising arm; Left... Read more
Left arm soreness progressively increasing now 18 hours after injection difficulty raising arm; Left arm soreness progressively increasing now 18 hours after injection difficulty raising arm; Night sweats last night, soaked sheets/pillow/mattress; This is a spontaneous report from a non-contactable pharmacist who reported for self. A 39-year-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration on 20Jan2021 14:30 at single dose on left arm for COVID-19 immunisation. Medical history was none. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. Concomitant medications included ascorbic acid (VIT C) at 1 g once daily, ubidecarenone (COQ10 [UBIDECARENONE]) at 100 mg once daily, valaciclovir hydrochloride (VALTREX) at 500 mg once daily, all from unknown date for unknown indication. On 20Jan2021 at 16:30, patient experienced left arm soreness progressively increasing 18 hours after injection difficulty raising arm and night sweats last night, soaked sheets/pillow/mattress. No treatment was received. Outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
39 2021-02-03 tingling Started feeling ill on 1/13 with fever, chills, aches and HA. By Thursday felt nerve tingling (has ... Read more
Started feeling ill on 1/13 with fever, chills, aches and HA. By Thursday felt nerve tingling (has had previous shingles). By Saturday starting to break out, went to Urgent Care for treatment. Called out 1/18
39 2021-02-04 migraine Migraine; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old male... Read more
Migraine; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 20Jan2021at single dose for covid-19 immunization. Medical history included allergies: penicillin, iodine, shellfish; asthma. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Concomitant medications were not reported. Patient experienced migraine on 21Jan2021 07:00 AM with outcome of recovered. No treatment was received for the event. No follow-up attempts are possible. No further information is expected.
39 2021-02-04 tingling dysaesthesia in the right arm (upper arm on the posterior aspect and forearm) and right hip/thigh; t... Read more
dysaesthesia in the right arm (upper arm on the posterior aspect and forearm) and right hip/thigh; the right shoulder, right elbow, and right hip joints are mildly sore; pins and neeles sensation; This is a spontaneous report from a contactable consumer who is the patient. A 39-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686) intramuscularly in the right arm on 11Jan2021 at 8:30 (at the age of 39-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included hypertension and migraines. The patient does not have allergies to medication, food, or other products. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EK5730) in the right arm on 18Dec2020. Prior to vaccination, the patient had not been diagnosed with COVID-19. The patient was administered the vaccine in a Hospital. The patient's concomitant medications were not reported. Beginning on 14Jan2021 the patient started to experience dysaesthesia in the right arm (upper arm on the posterior aspect and forearm) and right hip/thigh. Discomfort feels like pins/needles sensation anytime skin is touched lightly (such as blankets, clothing etc). As of the reporting date, the symptoms persist. In addition, the right shoulder, right elbow, and right hip joints are mildly sore which also are persistent. No perceived muscle weakness and no associated numbness. Treatment was not received for the events. Lab data included two post vaccination COVID 19 tests. A PCR nasal swab test on 11Jan2021 and a PCR nasal swab test on 17Jan2021 both of which were negative for COVID-19. The clinical outcomes of dysaesthesia, joint soreness and pins and needles were reported as not recovered.
39 2021-02-05 bell's palsy Symptoms of Bells Palsy that have gotten progressively worse since 2/3 til today 2/6. TX with Valtre... Read more
Symptoms of Bells Palsy that have gotten progressively worse since 2/3 til today 2/6. TX with Valtrex and prednisone. Outcome- TBD
39 2021-02-07 muscle spasms, migraine Patient reports that after recieiving dose 1 of the covid on Jan 5thvaccine he felt fatigue. then ... Read more
Patient reports that after recieiving dose 1 of the covid on Jan 5thvaccine he felt fatigue. then when he got his allergy shot on the 11th of Jan he had fatigue and cramps. he then had increased frequency and pain of migraines. he then develops muscle spasms which persisted. also reports erectile dysfunction. all symptoms worsened after he received his second covid vaccine on the 26th of January. he tried treating his headaches tih rizatriptan and naproxen whcih helped a little.
39 2021-02-10 pain in extremity Headache/ massive headache; Chills/ Shivers; Some fever 98.6/ temperature probably went up to 98-99;... Read more
Headache/ massive headache; Chills/ Shivers; Some fever 98.6/ temperature probably went up to 98-99; bodyaches; sore arm; This is a spontaneous report from a contactable consumer (patient himself, a dental hygienist, who worked in a dental office). A 39-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9262, expiration date was unknown), intramuscularly on the left arm on 25Jan2021 at 08:15 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the hospital, a public hospital. The vaccine was not administered at the military facility. Relevant medical history included ongoing migraines, which had been going on since he was in 20's, (condition began around 20 years prior reporting); allergies to pollen, grass, and dust; ongoing high blood pressure (HBP), which was diagnosed maybe about 6 years prior reporting; ongoing seasonal allergy, which started also in his 20's (around 20 years ago); slight shrimp allergy; tested positive for COVID-19 on 10Dec2020 (also reported as a month and a half ago); and diuresis. Concomitant medications included ongoing losartan (tablet; lot number: unknown, expiry date: 30Apr2022) for high blood pressure; ongoing hydrochlorothiazide (tablet; discard after date: 23Dec2021) as water pill; cetirizine hydrochloride (ZYRTEC); ongoing cetirizine hydrochloride (ALLERTEC) for allergy; ongoing ascorbic acid (ESTER-C) for vitamin C supplementation; ongoing ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium molybdate, sodium selenate, thiamine mononitrate, zinc oxide (NATURE MADE MULTI FOR HIM 50+, Tablet; lot number: 2393606, expiry date: Aug2022) as multivitamin that he only took once daily - supposed to take it twice daily, but they were big so he just takes one); ongoing chondroitin sulfate, glucosamine hydrochloride, hyaluronic acid (SCHIFF GLUCOSAMINE CHONDROITIN COMPLEX, "Schiff Move Free Joint Health," also says "advanced with glucosamine and chondroitin") as dietary supplement; and unspecified multivitamins. The patient had no prior vaccinations within 4 weeks. On 25Jan2021 at 17:00, the patient experienced headache, chills, some fever at 98.6, and body aches. It was further reported that the patient felt fine all day on 25Jan2021; he just had the sore arm. Mid afternoon, around 5pm, he started getting the shivers. He had a fever. The main thing was the chills and body aches. His temperature probably went up to 98-99. He also had a massive headache. He still had the headache at the time of the report, but it was not as bad. The patient stated he took ibuprofen (ADVIL) and took some dextromethorphan hydrobromide, doxylamine succinate, paracetamol, pseudoephedrine hydrochloride (NYQUIL, clarified as " Up and Up Brand Nighttime Cold and Flu" with lot number: 0EK0993, expiry date: Apr2022) last night. At the time of the report, he had taken 2 Advil's and some dextromethorphan hydrobromide, paracetamol, phenylephrine hydrochloride (DAYQUIL, clarified as " Up and Up brand Daytime Cold and Flu" with lot number: 0EK0735, expiry date: Sep2021). He had been drinking water and tea. He was okay at the time of the report. He still had a headache. When the effectiveness of the medication went away, his fever came back and his headache got more intense. He still had body aches, but they were little better after taking the medication. The adverse events (AEs) did not require any visit to an emergency room or a physician office. Therapeutic measures were taken as a result of headache, chills, some fever at 98.6, and body aches. The patient was not tested for COVID post vaccination. The patient was not recovered from all the events.
39 2021-02-10 pain in extremity dead arm; arm pain; This is a spontaneous report from a non-contactable consumer reported for himsel... Read more
dead arm; arm pain; This is a spontaneous report from a non-contactable consumer reported for himself. A 39-year-old male patient received bnt162b2, via an unspecified route of administration on 22Jan2021 at 05:00 PM in the right arm (dose: 01) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 at 08:00 PM, the patient had dead arm and patient thought they were exaggerating the extent of the arm pain and thought he was obligated to report. Patient did not receive treatment for the adverse events. The outcome of the events was unknown. No follow up attempts are possible. Information about lot/batch number cannot be obtained
39 2021-02-16 weakness Was fine after shot and waiting 15 minutes. Later on in the night around 7:30pm felt nauseas and vom... Read more
Was fine after shot and waiting 15 minutes. Later on in the night around 7:30pm felt nauseas and vomited slightly. Next day felt better but continued to feel "drained" like I had the cold of flu. Eventually by the 3rd day symptoms had subsided.
39 2021-02-16 feeling hot I received the vaccine Saturday afternoon. During the 15 minute waiting period I was warm but not fe... Read more
I received the vaccine Saturday afternoon. During the 15 minute waiting period I was warm but not feverish. No further adverse affects noticed for the remainder of the day. Sunday my left arm was sore at the injection site but no other issues. Sunday night/Monday morning I woke up at 1:30am and had diarrhea. I returned to bed and tossed and turned for another hour. I woke up at 2:30am and vomited. I had a restless night sleep for the remainder of the night. Monday I couldn?t get out of bed and suffered from chills. Tuesday I was tired but relatively fine. Wednesday I felt pretty much normal. Thursday was fine.
39 2021-02-17 facial pain, tingling excruciating pain on the left side my face; rash and swelling on the left side of my face; rash and ... Read more
excruciating pain on the left side my face; rash and swelling on the left side of my face; rash and swelling on the left side of my face; swelling of tongue; tingling in the face and tongue; tingling in the face and tongue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number: el3247, expiry date: not reported), via an unspecified route of administration on 18Jan2021 03:45 PM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a 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. Medical history was none. The patient had no known allergies to medications, food, or other products. The patient had no concomitant medications. On 26Jan2021 06:00 AM, the patient experienced "excruciating pain on the left side my face and then noticed a rash and swelling on the left side of my face and swelling of tongue. Also tingling in the face and tongue." Therapeutic measures received as a result of adverse events included prescribed medication. Adverse events resulted into doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. Outcome of the events was not recovered. The reporter assessed the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
39 2021-02-18 numbness Patient received 1st dose of Pfizer COVID-19 vaccine today at 0820 hours. At 0835 patient experience... Read more
Patient received 1st dose of Pfizer COVID-19 vaccine today at 0820 hours. At 0835 patient experienced Hypotension and dizziness, numbness, sweating and diaphoretic. Emergency response team arrived and assumed care of patient. Improved as he laid on liter and denied further obs in the ED. Stayed an additional 20 mins in the vaccine obs area and was stable when he left.
39 2021-02-21 involuntary muscle movements, tingling, slurring Slurred speech, disorientation, uncoordinated movement, tingles at fingertips and toes
39 2021-02-22 facial pain presenting to the emergency department via car for evaluation of Herpes Zoster to the left side of t... Read more
presenting to the emergency department via car for evaluation of Herpes Zoster to the left side of the patient's face. The patient was evaluated at Urgent Care yesterday and sent by the NP. Patient reports three days of rash to the left side of his face with redness and swelling. The patient initially thought the rash was acne due to his face mask. There is intermittent pain to the area which is rated 10/10 severity at its worst. The patient has been unable to sleep the past two days due to the pain. Pain is worse with cold weather and at night with increased clenching of his jaw and grinding of his teeth. He was prescribed Valtrex at Urgent Care and took one dose just PTA to the ED. There is concern given a bump just lateral to the patient's left eye. The patient received his first COVID-19 vaccination on 01/18/2021 and explains that the Urgent Care provider believes this may be an adverse reaction.
39 2021-02-22 feeling hot Aching body, mild headache, and feeling warm to the touch. Feeling of fatigue, tired, and generall... Read more
Aching body, mild headache, and feeling warm to the touch. Feeling of fatigue, tired, and generally lacking in energy. Difficult to conduct normal work duties. Feeling of tired and fatigue lasted for two days after vaccine. mild soreness at injection site, nothing debilitating.
39 2021-02-23 flushing After receiving 2nd dose Pfizer COVID vaccine, patient developed symptoms of being light headed and ... Read more
After receiving 2nd dose Pfizer COVID vaccine, patient developed symptoms of being light headed and dizzy. Observation RN reported he became flushed and appeared very anxious. She was going to continue to observe, but the patient requested to go ED for observation. Patient transported to ER, but did not require any additional treatment. Only required monitoring and was discharged.
39 2021-02-24 pain in extremity I had a sore arm that lasted about three or four days. It made it hard to hold anything heavy or lif... Read more
I had a sore arm that lasted about three or four days. It made it hard to hold anything heavy or lift it above my head for one day. One week later, I developed severe hives, and itching all over my body and it didn't stop until about 24 hours later. I went to urgent care. They put me on Prednisone.
39 2021-02-27 muscle spasms Swollen joints for 48+ Hours after each dose headache Muscle and nerve spasms
39 2021-03-03 flushing Patient received first dose of Pfizer vaccine at 1505. Patient waiting designated 15 minutes under s... Read more
Patient received first dose of Pfizer vaccine at 1505. Patient waiting designated 15 minutes under supervision. Patient reported reading email and then noted difficulty reading email and notified RN. Notified to go to Clinic check out due to patient's report of "light headed, like I had a drink or something.". Reported heart racing. Heart rate 112 and BP 130/86 initially. Upon patient being supine, heart rate elevated to 123. Symptoms improved and then start again. Flushed area around neck. "I think I'm okay.: "I feel so much better." Patient reported, "I felt out of it. Like I had a drink of something." Patient continued to wait under supervision of RN. Upon reassessment, sitting blood pressure of 118/78, heart rate 79, and oxygen saturation of 90% on room air. "I feel fine. After two waves of weirdness." Patient left at 1540. Patient reported symptoms had resolved.
39 2021-03-04 unresponsive to stimuli Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: ... Read more
Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe
39 2021-03-11 weakness, muscle twitching Fever , body aches , legs buckled and almost fell over , arm twitched a few times , nausea, eyes com... Read more
Fever , body aches , legs buckled and almost fell over , arm twitched a few times , nausea, eyes completely bloodshot & glassy looking , extreme fatigue
39 2021-03-14 weakness fatigue that is not going away feeling of being run-down constantly
39 2021-03-15 bell's palsy, facial paralysis Bell's Palsy; got the shot around 9 am and facial paralysis began around 9 pm.
39 2021-03-15 numbness, tingling Left sided facial numbness and tingling. Dizziness and lightheadedness. Mild headache. Mental foggi... Read more
Left sided facial numbness and tingling. Dizziness and lightheadedness. Mild headache. Mental fogginess.
39 2021-03-15 tremor 39y/o male presents with syncope, head injury and body shaking within 5min of receiving Pfizer vacci... Read more
39y/o male presents with syncope, head injury and body shaking within 5min of receiving Pfizer vaccine in left arm on 3/16/21. Patient lost consciousness, fell from a seated position and hit the left side of scalp on the floor. Patient then experienced uncontrolled body shaking for <5sec. He had drool from his mouth during episode. Patient regained consciousness after cessation of shaking. He reports associated sweating and head pain. He denies throat enclosing, difficulty speaking, lip/tongue swelling or itching, injection site pain or itching, blurring of vision, light headedness, chest pain, palpitations, or shortness of breath. He reports history of syncope when getting his blood drawn and at site of blood. He denies allergies to medication or vaccinations. He denies any current medical conditions or h/o seizures. On physical exam: Vitals: Heart rate 88, blood pressure 150/100 Skin: his skin is diaphoretic and ~4x2cm skin abrasion to his left scalp is noted. Cardiovascular: Radial Pulse 2+ . Heart regular rate and rhythm. Lungs: clear to auscultation bilaterally Patient was examined by EMS and informed that he could be transported to hospital via ambulance for immediate consultation with provider or can decline services and seek care at a later time. Patient opted to drive on his own to seek care at a later time. He was advised to contact his primary care provider regarding his adverse reaction, seizure and head injury. Note: MA called for PA on site when patient fell and hit head. PA told site manager to call 911 while attending to patient. When PA arrived to patient's side, he had regained consciousness and PA proceeded to provide care and investigate incident.
39 2021-03-17 tingling, cold sweat About 7 minutes post 1st dose vaccination, patient began to feel lightheaded, clammy, tingling, naus... Read more
About 7 minutes post 1st dose vaccination, patient began to feel lightheaded, clammy, tingling, nauseas, and diaphoretic. He was brought to lay down and vitals were taken. His vitals were stable and upon laying down he began to feel better. He stated he felt tingling in his left arm but it was just for a few minutes. He denies any numbness, rash, CP, SOB, HA, or palpitations. Patient reports he usually has a vaso vagal reaction when he gets his blood drawn. He felt better about ten minutes of laying down and water was provided. He declined transportation to the hospital but agreed to follow up with his PCP or the ER if he has worsening symptoms. Patient was stable upon leaving the vaccination POD.
39 2021-03-17 seizure like phenomena, unresponsive to stimuli Patient verbalized he felt he might pass out. Then he had seizure like activity and no response to e... Read more
Patient verbalized he felt he might pass out. Then he had seizure like activity and no response to external stimuli.
39 2021-03-18 bell's palsy, facial paralysis Loss of taste, facial paralysis. Dx of Bell?s Palsy
39 2021-03-21 feeling cold aches in the lower back, followed by cold extremities shortly after in the early evening. By midnig... Read more
aches in the lower back, followed by cold extremities shortly after in the early evening. By midnight I had a fever over 102* and bad chills throughout the night with very little sleep. the next day (Friday) I had a fever of 100* all day while on Tylenol and ibeprophin alternately. I stayed home from work to try to rest, but was fatigued all day. By Friday evening I started regaining strength, aches subsided and temperature was back to normal.
39 2021-03-21 feeling hot Hot, diaphoretic, lightheaded Narrative: felt lightheaded, dizziness, layed down, at 12:18 VS HR 78... Read more
Hot, diaphoretic, lightheaded Narrative: felt lightheaded, dizziness, layed down, at 12:18 VS HR 78, BP 110/73, RR24, 12:28 HR 85, BP 129/92, RR12, 12:39 HR 70, BP 124/85, RR 14, felt better after H2O, pt left with sx resolved at12:39
39 2021-03-21 numbness, tingling Patient is a 39 y.o. male who was seen at COVID Vaccine Clinic today for his second dose of the COVI... Read more
Patient is a 39 y.o. male who was seen at COVID Vaccine Clinic today for his second 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 numbness and tingling in the left arm and aching in left hand. He denied rash, hives, difficulty breathing, wheezing and lightheadedness. He takes no daily prescription medications. 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 skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, dizziness and headaches +numbness and tingling of left arm/hand: Previous Reactions: Denies reactions to prior vaccines. Objective Vitals Vitals: 03/22/21 1025 03/22/21 1042 03/22/21 1054 BP: (!) 165/93 (!) 153/95 (!) 138/92 Pulse: 79 70 72 SpO2: 97% 98% Blood Sugar 286 collected at 10:29am. Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. 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. Musculoskeletal: Comments: Equal grip strength in bilateral hands. No weakness noted in upper extremities. Skin: General: Skin is warm and dry. Findings: No erythema or rash. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Assessment/Plan Treatment included: no therapy 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) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Encouraged patient to follow up with PCP for annual labs and physical. BP improved prior to discharge.
39 2021-03-22 weakness, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe
39 2021-03-24 weakness Chills, weakness, fatigue
39 2021-03-25 numbness, facial paralysis Within an hour of the shot, started feeling dizzy. Intense fatigue and full body aches set in withi... Read more
Within an hour of the shot, started feeling dizzy. Intense fatigue and full body aches set in within 3 hours. Facial numbness and left-side facial drooping began within 8 hours. Low fever, chills, heavy heart beat, and intermittent cramps of the abdomen and on the left side (between hip and rib cage) began within 18 hours. Swollen lymph nodes in the neck and constipation began within 48 hours. At ~4 days since the first shot, the facial numbness, heavy heart beat, and fatigue persisted, though the drooping became less prominent and the other symptoms have largely resolved. At ~2 weeks since the first shot, the facial numbness has been constant, but varying in intensity, and the left-side facial drooping has returned multiple times.
39 2021-03-25 tingling tingling all over forehead, nausea vomitting, released in stable condition
39 2021-03-28 feeling hot Administered second dose of Pfizer Covid 19 vaccine. After 5 minutes, patient stated that he was fee... Read more
Administered second dose of Pfizer Covid 19 vaccine. After 5 minutes, patient stated that he was feeling hot, having a scratchy throat and wanting water. Prepared Epipen for possible anaphalaxis reaction. Patient stated that he was not having difficulty breathing therefore the decision was made just to monitor patient. No medications administered. Patient then stated that he was feeling a bit dizzy. Tested patients blood pressure with no issue. Patient was asked to wait for 30 minutes to be monitored for any changes. Atter 30 minutes patient stated that he was doing well with no issues. Asked patient to wait for a bit longer just to make sure, patient agreed. No other issues present and patient was able to leave. Followed up with patient later in the day and he stated that he was doing well with no issues.
39 2021-03-28 numbness Numb left side face
39 2021-03-28 muscle spasms Painful cramping of muscle in upper right back. Pain 2/10. Pain decreased to 1/10 by the next morni... Read more
Painful cramping of muscle in upper right back. Pain 2/10. Pain decreased to 1/10 by the next morning, and was fully resolved approximately 36 hours after onset.
39 2021-03-28 pain in extremity Fever, sore arm, body aches, shortness of breath
39 2021-03-28 pain in extremity Groin pain Swollen lymph nodes in groin and abdomen Left Testical pain Abdomin pain Sore left arm
39 2021-03-28 pain in extremity 3 days after I received the vaccine, the muscle on top of my forearm near the elbow (approximately w... Read more
3 days after I received the vaccine, the muscle on top of my forearm near the elbow (approximately where the "funny bone" is located) has been very sore and still is as of this writing. It hurts to straighten my arm out. It hurts to bring my fist to my shoulder. It hurts to clench my fist tight. It's affecting my capabilites at work. I delayed reporting it because I thought it was just from getting a shot and would pass.
39 2021-03-29 pain in extremity Inflammation and pain that progressed from upper body to lower body over 3-4 days. Upper body pain a... Read more
Inflammation and pain that progressed from upper body to lower body over 3-4 days. Upper body pain and inflammation subsided while the side effects moved to lower body extremities.
39 2021-03-29 tingling Systemic: Tingling (specify: facial area, extemities)-Severe
39 2021-03-30 weakness, numbness, pain in extremity DURING THE SECOND DOSE OF COVID VACCINATION THE INJECTION WAS ADMINISTERED INTO MY ARM TENDON HIGH U... Read more
DURING THE SECOND DOSE OF COVID VACCINATION THE INJECTION WAS ADMINISTERED INTO MY ARM TENDON HIGH UP ON THE SHOULDER BONE. IT HAS BEEN VERY PAINFUL. NOW I AM EXPERIENCING WEAKNESS, ARM PAIN, AND NUMBNESS. IT SORTA FEELS LIKE THE ROTATOR IS LOOSE OR WEAK. THERE IS A SMALL BRUISE IN THE AREA HIGH UP ON THE SHOULDER AS WELL.
39 2021-03-30 facial paralysis, numbness left-side facial drooping began within 8 hours; feeling dizzy; ntense fatigue; full body aches; Faci... Read more
left-side facial drooping began within 8 hours; feeling dizzy; ntense fatigue; full body aches; Facial numbness; Low fever; chills; heavy heart beat; intermittent cramps of the abdomen and on the left side (between hip and rib cage); Swollen lymph nodes in the neck; constipation; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 11Mar2021 12:15 (lot number: EN6208) as single dose at the age of 39 years old for COVID-19 immunisation. Medical history included allergies: minor reaction to iodine CT contrast. Concomitant medications included fish oil, turmeric [curcuma longa rhizome] (TURMERIC), and xantofyl (LUTEIN); all taken for an unspecified indication, start and stop date were not reported. The patient previously took iodine and experienced allergies (minor reaction to iodine CT contrast). On 11Mar2021 12:45 PM, within an hour of the shot, the patient started feeling dizzy. Intense fatigue and full body aches set in within 3 hours. Facial numbness and left-side facial drooping began within 8 hours. Low fever, chills, heavy heartbeat, and intermittent cramps of the abdomen and on the left side (between hip and rib cage) began within 18 hours. Swollen lymph nodes in the neck and constipation began within 48 hours. Facial numbness, heavy heartbeat, and fatigue persist, though drooping has become less pronounced and the other symptoms have largely resolved at 100 hours since the first shot. Seeking guidance on whether further medical help should be sought (did nurse line call with insurance company) and whether the booster shot should be administered. The AEs resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the adverse events. The patient has not been tested for COVID post vaccination. The patient was not diagnosed with COVID prior to vaccination. No other vaccines received four weeks prior to COVID vaccination. Outcome of the events was recovered with sequelae.
39 2021-03-30 hot flush Fever/hot flash, sneezing
39 2021-03-30 limb paralysis called in regards to his sister who received her second Pfizer dose on Friday 03/26/2021 @1100. repo... Read more
called in regards to his sister who received her second Pfizer dose on Friday 03/26/2021 @1100. reported that his sister developed fever, congestion, runny nose, sore throat, arm hurts. reported that his sister have no allergies and no medical history, patient was instructed that she can take tylenol for the headache and the fever. patient was instructed that she can apply cold compress to help with the arm soreness. patient was instructed to seek medical attention if the symptoms got worse. Adverse events experienced and are they still occurring now: fever, congestion, runny nose, sore throat, arm hurts 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): they called us
39 2021-03-30 unresponsive to stimuli The patient fell down on the floor about less than 5 min after vaccinated (while waiting for the 15m... Read more
The patient fell down on the floor about less than 5 min after vaccinated (while waiting for the 15min observation period), hit his head on the shelf. After turned him over, his eyes were half closed, unconscious, non-responsive and were not breathing properly. Administered an epi-pen 0.3mg, the patient woke up immediately. Also called 911, EMS came and he was able to get up and walk.
39 2021-03-31 bell's palsy Vaccine given on 3/20/21 and patient developed symptoms consistent with bells palsy on 3/26/21. Diag... Read more
Vaccine given on 3/20/21 and patient developed symptoms consistent with bells palsy on 3/26/21. Diagnosed and treated at urgent care
39 2021-03-31 pain in extremity Arm soreness, fatigue
39 2021-04-02 weakness Heart rate 104, dizziness, weakness, Fever 101.8, chills, headache, tiredness, muscle pain, feeling... Read more
Heart rate 104, dizziness, weakness, Fever 101.8, chills, headache, tiredness, muscle pain, feeling unwell.
39 2021-04-02 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out. Patient was responded to immediately. Blood pressure was checked and 911 was called. EMS evaluated patient and determined that the patient is okay.
39 2021-04-02 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out. 911 was called. Blood pressure was checked. EMS arrived and determined that patient was okay.
39 2021-04-04 numbness, tingling Initially symptoms were fatigue. About 64 hours after my second vaccine dose I began feeling slightl... Read more
Initially symptoms were fatigue. About 64 hours after my second vaccine dose I began feeling slightly dizzy. This has continued for an entire week (10 days after shot) and still persists, also some tingling and numbness in my legs and feet.
39 2021-04-05 involuntary muscle movements, muscle spasms, feeling jittery, tremor I received the 1st dose of the Pfizer Covid-19 Vaccine on 3/31/21 at High School. Within a few minu... Read more
I received the 1st dose of the Pfizer Covid-19 Vaccine on 3/31/21 at High School. Within a few minutes of receiving the shot, I started to have muscle cramps in my calves and arms, joint pain, general feeling of anxiousness and jitteriness. My right hand started to shake and it was difficult to completely control the use of my fingers on my right hand. It was difficult to hold onto a water bottle cap or pick up my iPhone to call my wife. It was like I temporarily lost some fine motor skills in the fingers of my right hand. Overall, this lasted for more than 30 minutes. I drove to get the vaccine by myself, however my wife had to drive me home. We got home about an hour after the shot. When I got home I changed into looser fitting clothing and felt much better. I did not need medical attention. On 4/6 I had similar symptoms but not as strong so I contacted my dr. They advised to get a Covid 19 test today.
39 2021-04-05 hot flush Received 2nd shot on April 2, 2021 that night had headaches, Hot flashes,. Saturday April 3 rd head... Read more
Received 2nd shot on April 2, 2021 that night had headaches, Hot flashes,. Saturday April 3 rd headaches all day and. Tuesday April 6 woke up itchy all over body and later that day developed rash and hives.
39 2021-04-06 pain in extremity 1. Sore arm, no treatment, resolved on its own:, lasted roughly 48-60hours hours post vax 1. Headach... Read more
1. Sore arm, no treatment, resolved on its own:, lasted roughly 48-60hours hours post vax 1. Headache, no treatment, resolved on its own:, lasted roughly 48-hours hours post vax 1. Malaise, no treatment, resolved on its own:, lasted roughly 48-hours hours post vax
39 2021-04-06 pain in extremity fatigue/so tired, he can barely can move; silver dollar rash at the injection site; his whole calf w... Read more
fatigue/so tired, he can barely can move; silver dollar rash at the injection site; his whole calf was constricted, felt like the muscle was separating inside, compared it to the same feeling of DVT; he is limping today; feeling pain in arm; left arm hurts so bad that he can hardly move it; fever; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient, self-reported). A 39-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER8730; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 24Mar2021 17:00 as SINGLE DOSE for COVID-19 immunization. Medical history included DVT (deep venous thrombosis) 3 years ago in his right calf/DVT of calf from 2019 to an unknown date (Right Calf; DVTs in his calf and had treatment with Eliquis and got off of that, had an ultrasound to check that it was gone); broke his ankle on an unspecified date in 2019; being in a tourniquet too long (DVT (deep venous thrombosis) 3 years ago in his right calf, from being in a tourniquet too long, was in an operation, was treated with ultrasound); normally when something hurts that bad, he has a softball size bruise on his arm, he has lived and had bruises like that before; Operation (DVT (deep venous thrombosis) 3 years ago in his right calf, from being in a tourniquet too long, was in an operation, was treated with ultrasound/rebreak his ankle and put rods and screws in). The patient's concomitant medications were not reported. It was reported that feeling pain in arm on 24Mar2021, fatigue on 25Mar2021, fever on an unknown date in Mar2021, silver dollar rash at the injection site on 25Mar2021. He reported that he had DVT (deep venous thrombosis) 3 years ago in his right calf, from being in a tourniquet too long, was in an operation, was treated with ultrasound. This morning (25Mar2021), his whole calf was constricted, felt like the muscle was separating inside, compared it to the same feeling of DVT that he had those years back. Patient reported that he thought he might be having allergic reaction. He was so tired, he can barely can move, he had a silver dollar size rash on his arm and his arm hurts so bad that he can hardly move it. He stated that this was weird and he has it every now and then, but it is really bad today. He states that 3 years ago he had DVTs in his calf and had treatment with Eliquis and got off of that, had an ultrasound to check that it was gone. He stated that his leg and it hurts so bad. It felt like has phantom clots in the same the muscles are separating again, like the muscle is trying to tear itself in half. Caller asks, the vaccine won't cause blood clots, will it?. Described about Tired, he couldn't get out of bed and he had been laying there for 3 hours this morning. Stated he ate dinner and went to bed. Stated that he works a full time job doing HVAC and goes to school full time so he could've been tired last night and not noticed it, because he is always tired, but today was different. Described about Left Arm Hurts, that it felt like when you play dead arm, that is when a person socks another kid in a certain spot, felt like he was hit with a bat in that spot. Hurt bad and he was surprised how bad it hurt. When he got the injection, he felt nothing. Now he feels like he fell down on his arm. Within a few hours he noticed it and thought it would probably go away. States that he was checking to see if he had a big ole bruise, and that when he noticed the rash. He stated that normally when something hurts that bad, he has a softball size bruise on his arm. States that he has lived an had bruises like that before. Described about Phantom DVT Pain: He stated that his leg started twitching and woke him up. he called it phan-tom DVT, it felt like DVT, like the muscles have memory and start contracting and get so tight like they are tearing each other apart again. Stated that he is limping today (25Mar2021). He stated that it was contracted for 10 minutes and his whole calf was tight. It was his right leg, the same leg as he had 3 blood clots in. He stated that he broke his ankle in 2019 and they left the tourniquet on too long and they had to rebreak his ankle and put rods and screws in and he developed DVTs in his right calf. Stated that it was treated and he had ultrasounds at 3 months, 6 months, and a year and it is all gone and he has had no symptoms since. He stated that it felt like he has 3 blood clots back hardcore with a vengeance. Stated that he had no edema in his foot, it is not full or swelling or trust him he would be running, well not running, but he would be going to the hospital. Patient was not received treatment for the events. Seriousness of the events was reported as Non-serious. Outcome of the events Fever and limping was reported as unknown and outcome of all other events was not recovered.
39 2021-04-06 pain in extremity 1. Sore arm lasting roughly 48-60 hours post vaccination; 2. Headache lasting roughly 48 hours post ... Read more
1. Sore arm lasting roughly 48-60 hours post vaccination; 2. Headache lasting roughly 48 hours post vaccination; 3. Malaise lasting roughly 36-48 hours post vaccination.
39 2021-04-06 tingling Patient became very pale, sweating profusely, nauseous, described fluttery/pins feeling in feet, leg... Read more
Patient became very pale, sweating profusely, nauseous, described fluttery/pins feeling in feet, legs, and hands, on the verge of losing consciousness within 10 minutes of administration of the injection. Patient was offered cool sips of water and orange juice by mouth, explained they had not eaten, yet, that day, though replied negative to being diabetic. BP and heart rate checked out normal. Patient remained at administration site for an hour after injection before being able to depart under own power. Partner drove them home.
39 2021-04-06 unresponsive to stimuli Pt noted to have Syncopal episode, pale skin and diaphoretic, unable to arouse at this time, verbal ... Read more
Pt noted to have Syncopal episode, pale skin and diaphoretic, unable to arouse at this time, verbal stimuli attempted with no response, sternal rub successful ( patient responded with a audible groan). MD notified for evaluation. Paramedic summoned, 911 EMS summoned on scene for transportation. Pt alertness increased, pt became combative when onsite staff attempted to escort to ambulance, . Pt agreed to be evaluated. Hospital contact made by medic. Pt refused care. Scene cleared by vaccine site.
39 2021-04-07 hypersensitivity of all senses 48 hrs after vaccine, extreme lethargy, fatigue, nausea, hyperalgesia, fever of 100 degrees, diahrea... Read more
48 hrs after vaccine, extreme lethargy, fatigue, nausea, hyperalgesia, fever of 100 degrees, diahreah, muscle aches. All side effects persist despite alternating advil and tylenol now on day 6. Took PCR covid test in case on 4/4/21 and was negative.
39 2021-04-07 tremor, unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild
39 2021-04-08 muscle twitching Patient lost consciousness about 10-15 seconds after vaccination administered. Concerned initially ... Read more
Patient lost consciousness about 10-15 seconds after vaccination administered. Concerned initially that patient may have been having a seizure due to twitching motion of head lasting 2-3 seconds. Then patient appeared to be sleeping. He was breathing, but audibly snoring and it seemed somewhat irregular. I moved patient from chair to floor and had staff call 911. Patient was still breathing but remained unconscious for about 1.5-2 minutes. He then woke abruptly and was immediately lucid. He was awake when EMS arrived. He stated he has passed out on previous occasions of abrupt pain/use of needles. EMS monitored patient for around 20-30 minutes, and he also had a bottle of orange juice and a granola bar and appeared to feel better. Patient declined transport to hospital by emergency personnel.
39 2021-04-09 hot flush Strong stomach cramping, hot flashes, chills
39 2021-04-09 seizure seizure like violent tremors in the middle of the night.; This is a spontaneous report from a contac... Read more
seizure like violent tremors in the middle of the night.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received second dose of BNT162B2 [PFIZER-BIONTECH COVID-19 VACCINE (also reported as MODERNA; pending clarification), solution for injection, lot number and expiry date were not reported], via an unspecified route of administration, administered in the left arm on 25Mar2021 13:00 (at the age of 39 years old) at a single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient experienced seizure like violent tremors in the middle of the night on 26Mar2021 04:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications received within 2 weeks of vaccination. The outcome of the event was recovering. Information on the batch/lot number has been requested.
39 2021-04-10 pain in extremity Arm pain started evening of 4/8 , rest started afternoon of 4/9 arm hard at site of injection, slig... Read more
Arm pain started evening of 4/8 , rest started afternoon of 4/9 arm hard at site of injection, slight nausea, slight headache, slight body aches, slight chill, slight brain fog, Everything cleared by morning of 4/10 except arm still slightly tender at time of this report
39 2021-04-11 hot flush In the Morning after my shot, I was getting breakfast ready for my kids. Everything seemed fine at t... Read more
In the Morning after my shot, I was getting breakfast ready for my kids. Everything seemed fine at the time and I started getting an odd feeling. Not really a dizzy or lightheaded feeling, but an odd feeling. The next thing I know, I came to on the floor. My security camera in the living room caught part of it from down a hall. I fell strait forward, onto my stomach with a large crash. The rest of the day, I did feel fatigue, joint pain in my knees and then chills/hot flashes later in the day/evening. The next morning (Friday) I woke up with a scratchy throat but felt fine the rest of the day. I have never fainted in the past. I don't know what would bring that on. I also have not had that feeling or any fainting spells since that incident. My wife came home about 8am out of concern.
39 2021-04-12 numbness Suspected Transient Ischemic Attack four days after receiving second dose of Pfizer Covid vaccine, w... Read more
Suspected Transient Ischemic Attack four days after receiving second dose of Pfizer Covid vaccine, with symptoms including sudden onset, inability to focus eyes, facial numbness on left side, headache, numbness moved around, involved left leg, left arm, left side of face, left side of lips and tongue. Numbness symptoms resolved after approximately thirty minutes; headache remained for approximately 6 hours; fatigue lasted until the following day. No medical care was sought at the time or subsequently.
39 2021-04-12 seizure seizure one week after second dose
39 2021-04-13 cold sweat Patient passed out after receiving his first Pfizer covid19 vaccination. He fell to the ground, but ... Read more
Patient passed out after receiving his first Pfizer covid19 vaccination. He fell to the ground, but does not believe he hit his head. He came to not too long after and stated that this has happened before when he has dealt with needles. Other symptoms include patient feeling clammy. His BP was taken three times and read 97/59. 156/108, and 134/94.
39 2021-04-14 pain in extremity At 1730 same day of vaccine, patient began feeling itching in bottom of feet. Spread to itching arm... Read more
At 1730 same day of vaccine, patient began feeling itching in bottom of feet. Spread to itching arms. At 3am next morning, patient noticed wrists/hands/fingers swelling. 4/14/21 afternoon, reported pain in heels, ball of feet. 4/15/21 reports increased swelling wrists/hands/fingers as well as swelling in forearms, ankle, bottom of feet.
39 2021-04-14 pain in extremity *Lip swelling, numb lip, (right lower lip) Others: Fever, arm pain
39 2021-04-14 tingling Client had a chief complaint of light headedness and body tingling. Pt was Alert, oriented, to time,... Read more
Client had a chief complaint of light headedness and body tingling. Pt was Alert, oriented, to time, place, location, and person A/Ox4, Glasgow Coma Scale 15, Airway, breathing, and circulation intact. Patient denied any pain or difficulty breathing but presented with slight pallor and agitation. Pt has no prior allergies and no pertinent medical history. Pt was given water, Benadryl 50MG, and monitored for an extra 30mins, Vitals were taken every 5mins for 30mins. Client reported feeling better after taking Benadryl. Pt felt better and was ready to go home and didn't want to stay for additional observation. Emergency precautions were given and follow up with Provider was recommended.
39 2021-04-15 discomfort, cold sweat, pain in extremity Patient is a 39 y.o. male with no significant past medical history who came to the ED with a sudden ... Read more
Patient is a 39 y.o. male with no significant past medical history who came to the ED with a sudden onset of chest pain that radiated initially to his right shoulder then to his left shoulder, left arm and back with intensity of 7/10 starting Tuesday 4/13/21 associated with sob that is worse when laying flat or taking a deep breath States he received his second Pfizer vaccine on Sunday, 4/11/2021 at 11 AM and started experiencing fever, chills, headaches, body aches and uncomfortable around 11 PM. He finally decided to take Tylenol x2 on Monday between 2 PM and 11 PM with some relief. He felt a little better on Tuesday morning and did some work from home but later around 7 PM, he notes a temp of 100.2, experienced body aches which he attributes to Vaccine side effects because his wife was also not feeling well post Vaccine. He went to bed and woke up later with cold sweats, felt pain in his chest and back. He described his chest pain as constant pain/heaviness that "felt like someone is sitting on his chest", he later felt pain in his left arm and back prompting ED evaluation. He denies similar episodes in the past, denies abdominal complaints, denies lightheadedness or dizziness, palpitations, shortness of breath at rest, orthopnea, PND, syncope, denies urinary complaints, denies smoking, drinks alcohol socially. States his father has CAD and MI x2 with stent in his 50s, his mother is doing okay with no cardiac history. In the emergency room, his EKG is consistent with pericarditis, initial troponin noted as 4.24 with repeat noted at 8.91, his LFTs are elevated at 107/123. He received full dose aspirin, Lopressor 25 mg with improvement in pain. IMG cardiology is on board with plan for cardiac cath today by doctor. Echocardiogram showed EF of 35-40% with wall motion abnormalities with initial reading.
39 2021-04-15 pain in extremity In the evening if the injection and through the following day I started to have brain fog or forgetf... Read more
In the evening if the injection and through the following day I started to have brain fog or forgetfulness and the inability to concentrate. I also had occasional sharp but temporary pains in my chest and in my toe joints. Very minor headache.
39 2021-04-16 pain in extremity Headache same day, right side of head. Lasted for about 4 hours. Arm started feeling sore. Next day,... Read more
Headache same day, right side of head. Lasted for about 4 hours. Arm started feeling sore. Next day, arm very sore at sight of injection. Day 3: soreness almost completely gone, but random nose bleed.
39 2021-04-16 unresponsive to stimuli presents with a potential reaction to the COVID19 vaccine. The patient was found by an RN responder ... Read more
presents with a potential reaction to the COVID19 vaccine. The patient was found by an RN responder in-vehicle unresponsive with a closed airway. RN performed head tilt jaw thrust maneuver and patient's airway opened with the spontaneous return of consciousness. EMS was summoned to the vehicle and vitals were obtained. BP 158/94 P 77 SpO2% 98%. The patient rapidly returned to baseline with oral hydration and increased monitoring.
39 2021-04-17 weakness Chills, shivering, aches, weakness, dizziness, sweating and swollen lymph node.
39 2021-04-17 weakness first night, 104 F fever and chills, complete body pain, weakness, sleepless, headache next day fel... Read more
first night, 104 F fever and chills, complete body pain, weakness, sleepless, headache next day felt almost normal, maybe just weak and tired next night, bad sore throat, bad runny nose, slight headache on going 4/18/21. 6PM
39 2021-04-17 pain in extremity Initial reaction was achiness in arm for about 24 hours. No troubles since. However, today, 6 days l... Read more
Initial reaction was achiness in arm for about 24 hours. No troubles since. However, today, 6 days later, in the morning, both eyes felt "heavy," swollen and puffy. I took a nap for about an hour around 11 am, and right eye significantly improved. Left eye remains the same: heavy, puffy, and swollen. I took a pill of Benadryl, and applied ice.
39 2021-04-17 tingling He felt like he was going to pass out, like he was disoriented; He felt like he was going to pass ou... Read more
He felt like he was going to pass out, like he was disoriented; He felt like he was going to pass out, like he was disoriented; He experienced disorientation; Itchiness on the abdomen area, knees, and toes; Feeling weird; feeling overwhelmed; Like itchy or pins and needles all over his body; Lightheaded; This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration in right arm on 25Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's prior vaccinations included tetanus shot on 09Feb2021. On 28Mar2021, 2 days after taking the first dose, the patient experienced reactions from the vaccine which included Itchiness on the abdomen area, knees, and toes and disorientation and went to emergency room for treatment. The patient wanted to know whether these are normal side effects of the vaccine. Upon follow-up on 28Mar2021, the patient reported that he felt weird after receiving the vaccine and lightheadedness. He told the nurse that he didn't eat before getting the vaccine. And wasn't sure if getting the vaccine was like having blood drawn so he hadn't eaten anything. The nurse told him he might be feeling lightheaded because he didn't eat and she gave him some lollipops and the patient felt much better. The patient also stated that on 28Mar2021, he was feeling overwhelmed and cannot describe the feeling. It was like itchy or pins and needles all over his body. The patient felt like he was going to pass out, as he as disoriented. The patient stated that he went to the Emergency Department. They kept him overnight, checked his heart, did some blood work, checked his blood sugar, gave him a Covid 19 test. The patient stated that everything came back normal. The Emergency Department concluded that the events could be due to the Covid 19 vaccine and described that his system was fighting the Covid 19 vaccine or something. The patient was asking if this is normal. He was also asking for a copy of this safety report for work purposes. The patient went to the Emergency Department on 28Mar2021 (around 7pm) and was in observation overnight. He was discharged from the Emergency Department this morning, 29Mar2021 at around 11:00AM. The patient confirmed that he was not hospitalized. The patient stated that he may be overthinking about the events and really paying attention to his body. He thinks he needs to rest as he was in the Emergency Department for a long time. The patient lab test included Blood sugar test. The outcome of the events was resolved for dizziness, unknown for feeling abnormal and overwhelmed and not resolved for other events. Information on lot/batch number obtained. Additional information has been requested.
39 2021-04-17 tingling Shingles. Tingling sensational around core felt approximately 4 or 5 days after shot and rash notice... Read more
Shingles. Tingling sensational around core felt approximately 4 or 5 days after shot and rash noticed after 6 days. Went to urgent care clinic and diagnosed with shingles. Received valacyclovir prescription with enough for 1 week. As of today, about 9 days following taking valacyclovir, shingles is improving but not gone. Note: the Department of Public Health and the Environment has shut down the clinic I received the shot and deemed the shots we did receive invalid because of inability to determine proper handling of the vaccine occurred.
39 2021-04-19 tingling Tingling in hands, feet, fingertips, Lips, and Face
39 2021-04-20 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: Pt fainted following second dose of vaccine, from sitting position, 20 minutes following vaccination. pt was back to normal about 30 minutes after fainting. pt declined any additional treatment or monitoring
39 2021-04-21 grand mal seizure Patient reports that he was sitting in chair, quite anxious, reporting that he had similar episodes ... Read more
Patient reports that he was sitting in chair, quite anxious, reporting that he had similar episodes in the past with fainting while aware of hypodermic needles. today, the patient reports that he felt himself beginning to pass out and lowered himself to the floor. Upon reaching the floor the patient sustained a period of unconsciousness for 10 seconds followed by 5 seconds of tonic clonic seizure activity. Patient awoke slightly confused and disoriented. Patient was completely alert and oriented about 30 seconds after event. Patient was brought back to EMS area and evaluated. Vitals signs were assessed and patient refused further medical care and transport to hospital.
39 2021-04-22 weakness, speech disorder, flushing Immediately after receiving vaccine my blood pressured dropped considerably (it was measured at 77 b... Read more
Immediately after receiving vaccine my blood pressured dropped considerably (it was measured at 77 by medical staff), I started sweating profusely, and briefly was unable to speak because I felt dizzy and felt as if I had no energy. After a few minutes, I recovered and my blood pressure resumed to normal (114). As this was happening, my partner-- who was with me when I experienced the allergic reaction--observed that my face suddenly became red and flushed (a minute after getting vaccination). Medical staff did not need to administer an Epipen. They had me lie down and breathe. After about 15-20 minutes I felt normal. Medical staff had me wait a total of 30 minutes before releasing me.
39 2021-04-22 impaired body coordination The patient had a sore throat for two days followed by severe polyarthralgias (pain in all of his jo... Read more
The patient had a sore throat for two days followed by severe polyarthralgias (pain in all of his joints) and fatigue. I sent him for evaluation in ER or urgent care. I suspect the possibility that this illness is possibly vaccine related but that is uncertain as there could be other explanations. He had his second immunization 3 weeks ago. He thinks he had covid 19 in March 2020 and had trouble "with his lungs" for about 3 months. An antibody test in September 2020 did not show antibodies to covid 19.
39 2021-04-22 paralysis Eye strain, possibly conjunctivitis. Some very slight flu like symptoms (sneezing, congestion)
39 2021-04-23 tingling at 13.5 minute mark after the injection, my face started to have an extreme tingle, I was unable to ... Read more
at 13.5 minute mark after the injection, my face started to have an extreme tingle, I was unable to swallow, chest was tight, then my arms also started to tingle. My heart rate was also fluctuating from 70-110 bpm while sitting down. The worst of it went away after 1 minutes, had mild symptoms for the rest of the day.
39 2021-04-24 feeling hot He received the vaccine and 5 to 10 minutes later got very hot, passed out, was communicating somewh... Read more
He received the vaccine and 5 to 10 minutes later got very hot, passed out, was communicating somewhat with the nurse who gave injection.EMS called and arrived minutes later. Pulse and oxygen level checked and ok. He stated had not had any food just coffee
39 2021-04-24 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
39 2021-04-25 burning sensation developed a heat burning sensation on the hip
39 2021-04-25 feeling cold, tremor Shaking uncontrollably and cold from 4:30-5:30 AM. Fatigue and tired for the next 24 hours. Brain ... Read more
Shaking uncontrollably and cold from 4:30-5:30 AM. Fatigue and tired for the next 24 hours. Brain fog when I woke up at 10:30 AM the next day. Fever coming and going until ~6 PM. Diahrea at 7 PM.
39 2021-04-25 flushing, tremor Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, ... Read more
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: anxiety and ptsd attacked trigered by the vaccine-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: 5 minutes after the dose, pt started having headache, sweating and shriveling, anxiety and ptsd attacked trigered by giving the vaccine, gave 1 dose of tylenol 500mg, called 911, pt was transfered to the hospital
39 2021-04-26 feeling of body temperature change headache; sore muscles throughout my body; alternating sense of hot/cold; general fatigue; strong so... Read more
headache; sore muscles throughout my body; alternating sense of hot/cold; general fatigue; strong soreness at the injection site (left arm); feeling chills; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm left on 16Feb2021 09:00 (Batch/Lot Number: EN 5318) (at the age of 39-years-old) as single dose for covid-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medication included desvenlafaxine succinate (PRISTIQ) 50 mg ER taken for an unspecified indication, from an unknown start date (two weeks prior to vaccination). The patient previously received BNT162B2 (Batch/Lot Number: EN 5318) dose 1 via an unspecified route of administration in left arm on 26Jan2021 at 12:00 for covid-19 immunisation. 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 the day when patient received second dose on 16Feb2021 at 21:00, he felt strong soreness at the injection site (left arm) and began feeling chills by the time he went to bed (12 hours after receiving the vaccine), but no other symptoms. On the following day (17Feb2021) when he woke up, he experienced a multitude of symptoms, including headache, sore muscles throughout my body, alternating sense of hot/cold, and general fatigue. These symptoms continued most of the day but began to subside by that evening. No treatment was given for the events. The outcome of the events was recovered on 18Feb2021.
39 2021-04-26 tingling Five minutes after vaccination, he felt "dizziness, weakness of lower extremities", tingling in bila... Read more
Five minutes after vaccination, he felt "dizziness, weakness of lower extremities", tingling in bilateral legs and feet. No problem walking. Gave water/juice. Stable, released from vaccination site.
39 2021-04-27 numbness Following morning (Thur) after receiving the vaccine, started feeling numbness on my face and swelli... Read more
Following morning (Thur) after receiving the vaccine, started feeling numbness on my face and swelling. Called my primary care Dr. to report symptoms. She advised I go to urgent care. I went to urgent care and they checked my blood glucose levels, EKG to check my heart was beating correctly. Urgent care advised I go to ER to get further evaluation done. I went to ER where they evaluated me. Advised this is an allergic reaction to the vaccine and to monitor. The following day (Fri) still felt slight swelling/numbness. Symptoms became worse in the evening called nurse line to explain swelling on my lip and face. Advised to take benadryl then go to ER. I went to ER in another location. ER Dr. advised this is an allergic reaction to the vaccine.
39 2021-04-27 migraine, pain in extremity Tinnitus, joint pain, muscle pain, migraines , left arm expressly sore
39 2021-04-27 tingling, numbness Pins and needles in toes started first, over the course of the month numbness became the main compla... Read more
Pins and needles in toes started first, over the course of the month numbness became the main complaint and has spread to calves, weak ankles. Pins and needles in fingers started the weekend after the first shot. Over the past month it has moved into tingling in the arms and numbness in fingers, back of hands.
39 2021-04-27 seizure seizure one week after second vaccine; This is a spontaneous report from a contactable consumer (pat... Read more
seizure one week after second vaccine; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Apr2021 at 11:00 as single dose for COVID-19 immunisation at the age of 39-year-old. Medical history was unknown and concomitant medications included ibuprofen (ADVIL), mometasone furoate (FLONASE). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Mar2021 for COVID-19 immunisation at the age of 39-year-old. On 11Apr2021, the patient experienced seizure; the patient was treated for the event. On unknown date, the patient underwent Computerised tomogram, Electroencephalogram, Magnetic resonance imaging (results unknown). The patient was recovering from the event. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. Information about lot/batch number has been requested.
39 2021-04-28 bell's palsy Monday after his vaccine he had pain in his lower neck to his ear on his Right side of his face. The... Read more
Monday after his vaccine he had pain in his lower neck to his ear on his Right side of his face. The pain persisted through the week and on Thursday his face had muscle drooping. They went to the urgent care and that is what he was diagnosed with as he had a previous episode 15 years ago.
39 2021-04-29 weakness Patient received second dose of Pfizer vaccine on 4/29/2021 at 8:50 AM. Patient reported feeling deh... Read more
Patient received second dose of Pfizer vaccine on 4/29/2021 at 8:50 AM. Patient reported feeling dehydrated and weak at work at 16:00 on 4/29/21. Patient reports symptoms worsening and includes: shortness of breath, passing out twice resulting in hitting his head on the bathroom wall, erythema on lower abdominal and shaking chills. EMS was called to patient's residence and found patient's O2 at 80% on room air and heart rate at 180s beats per minute. Of note, patient reported shortness of breath reaction after his first dose of Pfizer COVID-19 vaccine on 4/8/21 but did not feel the need to visit hospital. Patient came to the ED at 03:30 AM 4/30/21 and was admitted to hospital.
39 2021-04-29 weakness I had pain at the injection site the evening of receiving the injection, which still continues, thou... Read more
I had pain at the injection site the evening of receiving the injection, which still continues, though not too bad. Walking up today at around 7 am, I felt headache, achy all over, weakness, and some fever. I decided to stay home. I lay in bed most of the day, sometimes sleeping, sometimes watching YouTube videos on my phone. I was feeling kind of cold, so I snuggled completely under the covers, head and all. I got sweaty and had to uncover my head. I changed clothes. I got up a couple of times to urinate. Once, I felt some weakness, and had to support myself with my hand on the edge of the bathroom counter. Then, this afternoon, my headache was a bit worse. I got up to hop top the bathroom. I was urinating standing up, when I started feeling weak, so I supported myself with my hand, but almost immediately, I started feeling like I was going to fall, to faint, and to vomit. I hurriedly sat down on the toilet. I was still feeling nauseated and weak, so I learned back to take pressure off my abdomen, which was feeling slightly bloated. The bathroom fan was on, so it felt rather cold, but I started getting hotter and hotter, sweating profusely. At the same time, I just sat there trying to recover, and started feeling pins and needles in my forearms, but not like they had fallen asleep, just like someone were pressing down on my arms with blunt needles. I thought I was going to have to crawl back to bed. After a while, I started cooling off and feeling a little better. I went back to my room and changed clothes. I'm feeling warm and a bit weak and achy again, but nothing like that. I had only drunk 3 cups of water today, though I drank about 7 yesterday.
39 2021-04-29 pain in extremity Caller received his second COVID vaccine, yesterday 7:30 PM. Awoke today with chills, headaches, fe... Read more
Caller received his second COVID vaccine, yesterday 7:30 PM. Awoke today with chills, headaches, fever and pain in arm. Has been taking Tylenol for fever, however, his temp has gone from 97, to now 101.0. Last took Tylenol at 4:00 PM and chills are worsening. Encouraged to seek care at ED for these symptoms.
39 2021-04-29 tingling, tingling, tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
39 2021-04-30 pain in extremity Arm pain, persistent headache, tired and runny nose.
39 2021-05-02 burning sensation, tingling, muscle spasms Left arm burning. And cramping in elbow tingling in fingers for over a month. Went to healthcare fac... Read more
Left arm burning. And cramping in elbow tingling in fingers for over a month. Went to healthcare facility to check if should still get 2nd shot they told me I would need to see a neurologist. I got the 2nd shot 3 weeks after first shot and now issue spread into my neck muscles and leg cramps. Seems to be worse when it rains. Told me take anti-inflammatory but no help. My doctor gave me muscle relaxers neither has helped try ice and heat. Arm still burns. Took xrays. But I couldn?t get appointment with neurology til mid May.
39 2021-05-02 facial paralysis 39 year old male with right sided facial palsy, symptoms initiated 4/30/21 at 6 am. Patient diagnos... Read more
39 year old male with right sided facial palsy, symptoms initiated 4/30/21 at 6 am. Patient diagnosed with Bell's Palsy and started on appropriate steroid and antiviral treatment. Ongoing monitoring currently in progress.
39 2021-05-03 burning sensation Moderate headache that lasted 2 days. Starting 5 days later, started to develop a burning sensation ... Read more
Moderate headache that lasted 2 days. Starting 5 days later, started to develop a burning sensation in my right armpit. By 4-28-2021, several clusters of sensitive and itchy red bumps appeared in my right armpit, on the back of my right shoulder, and right pectoral. Symptoms persist as of today, waiting to be seen by a doctor. It appears like shingles. I have had chicken pox as a child, and have not ever had shingles or the shingles vaccine.
39 2021-05-03 cold sweat, tremor Light sensitivity, metallic taste in mouth, palor, shaking, GI upset, clammy skin, hypotension all r... Read more
Light sensitivity, metallic taste in mouth, palor, shaking, GI upset, clammy skin, hypotension all reported approximately 10 minutes after vaccination.
39 2021-05-06 night sweats Chills, headache, fatigue, dizziness, sensitivity to light, fever, night sweats, and muscle soreness... Read more
Chills, headache, fatigue, dizziness, sensitivity to light, fever, night sweats, and muscle soreness.
39 2021-05-06 tingling heart rate jumped from a normal 70 bpm to 90 then 110; face, tounge, lips and arm went extremely tin... Read more
heart rate jumped from a normal 70 bpm to 90 then 110; face, tounge, lips and arm went extremely tingly; face, tounge, lips and arm went extremely tingly; face, tounge, lips and arm went extremely tingly; It was hard to swallow; taking a breath felt empty; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 19Apr2021 12:30 (39-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included psoriasis and asthma as a kid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received ustekinumab (STELARA) 90mg on 24Jan2021; previously received sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergies. At the 13 minute mark of the safety wait time, his face, tongue, lips and arm went extremely tingly. It was hard to swallow, taking a breath felt empty and his heart rate jumped from a normal 70 bpm to 90 then 110 while sitting within a few seconds of the tingling starting. He sat for 10 more minutes then left the pharmacy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.
39 2021-05-07 burning sensation Helped someone move their household possessions two days prior to adverse effect, so wasn't sure if ... Read more
Helped someone move their household possessions two days prior to adverse effect, so wasn't sure if related. Observed a burning sensation in upper right pectoral major that moved through right armpit at boundary between biceps brachii and right deltoid. Felt tight during arm movements sway from torso and over head, bringing medium severity burning and tugging sensations under skin. Suspected lymph node irritation from 1st Pfizer shot or damage from moving heavy furniture. After 3-4 days the irritation in right pectoral ceased and burning and tight sensation in deltoid area lessened by approximately 50%. Today as I write this there is little of this persisting - only noticeable in right deltoid area when moving right arm to the most extreme limits of its possible positions, such as above and behind head. This produces a minor burning and tugging sensation in the right deltoid area which encourages slow and careful movement to this extreme position.
39 2021-05-08 migraine Since 48 hours after the shot, my wife and I have been extremely fatigued and dizzy. The fist week w... Read more
Since 48 hours after the shot, my wife and I have been extremely fatigued and dizzy. The fist week we suffered severe migraines, abdominal pain, fatigue and dizziness to the point of being incapacitated. A week later, we are still too dizzy to work/operate our vehicle and are always tired. Before this event, we are both in our 30?s, exercise at least an hour/ 5 days per week and have a very healthy diet. We went from the best shape of our lives to unable to function after this first shot. I have reached out to my clinic regarding my symptoms and they have no answers. I am terrified to get the second round as I have missed weeks of work due to this already.
39 2021-05-09 pain in extremity Had COVID-19 in July 2019. Afternoon of the second day after my first dose of Pfizer vaccine, develo... Read more
Had COVID-19 in July 2019. Afternoon of the second day after my first dose of Pfizer vaccine, developed minor chills/fatigue. Arm soreness persisted for several days, including swollen lymph node in my left armpit.
39 2021-05-10 pain in extremity, burning sensation has soreness and hurting at the injection site; right arm pain and burning getting pretty unbearable... Read more
has soreness and hurting at the injection site; right arm pain and burning getting pretty unbearable; from arm down to forearm; right arm pain and burning getting pretty unbearable; from arm down to forearm; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 13Apr2021 (Lot Number: ER8731) as SINGLE DOSE for COVID-19 immunization. The patient's medical history was none and concomitant medications were not reported. On 13Apr2021, the patient experienced soreness and hurting at the injection site and mentioned right arm pain and burning getting pretty unbearable; and that pain was radiating from arm down to forearm. Tylenol and Advil were considered as therapeutic measures. The outcome was not recovered for the reported events. No follow-up attempts are needed. No further information is expected.
39 2021-05-12 numbness, pain in extremity Same day of vaccination (1st dose) Patient reported 1)burning sensation in penis, 2)loss of use of a... Read more
Same day of vaccination (1st dose) Patient reported 1)burning sensation in penis, 2)loss of use of arms for period of time, followed by severe pain in arms. Continued numbness in arms. Patient scheduled follow-up appt with his HCP for 5/24.
39 2021-05-12 pain in extremity Sore arm
39 2021-05-12 tenderness, pain in extremity Next day after vaccination, the left elbow got swollen and painful to touch. The pain became tolerab... Read more
Next day after vaccination, the left elbow got swollen and painful to touch. The pain became tolerable after 2 weeks but did not disappear completely; the swollen area in the elbow somewhat reduced over time, but did not disappear completely.
39 2021-05-14 weakness Had 2 episodes of syncope; Shortness of breath; weakness; Fatigue; 80% O2 saturation on RA; Heart ra... Read more
Had 2 episodes of syncope; Shortness of breath; weakness; Fatigue; 80% O2 saturation on RA; Heart rate up to 180; Rash on his abdomen appeared; This is a spontaneous report received from a non-contactable pharmacist. A 39-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscularly administered in left arm on 29Apr2021 08:45 (Batch/Lot Number: EW0172) (age at vaccination: 39 years old) as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. On an unspecified date, prior to vaccination, the patient was diagnosed with COVID-19, unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. He had previously received the first dose of BNT162b2 on 08Apr2021 08:00 (Batch/lot number: EWP0158) (age at vaccination: 39 years old) as single dose for COVID-19 immunisation. Concomitant medication(s) included albuterol (ALBUTEROL) inhaler, naproxen (NAPROXEN) and calcium carbonate (CALCIUM CARBONATE), 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. On 29Apr2021, the patient developed shortness of breath, weakness, fatigue hours after administration of the vaccine. He had 2 episodes of syncope, 80% O2 saturation on room air (RA), heart rate up to 180. Rash on his abdomen appeared. The adverse events resulted in emergency room/department or urgent care. The patient was admitted to the hospital on an unspecified date in Apr2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported events 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.
39 2021-05-14 numbness, bell's palsy eyes are watery, more on the right, top to bottom feels numb/paralyzed type feeling. Seems to be a B... Read more
eyes are watery, more on the right, top to bottom feels numb/paralyzed type feeling. Seems to be a Bell's palsy type symptom but no drooping; Right side of my face is numb; eyes are watery, more on the right, top to bottom feels numb/paralyzed type feeling.; eyes are watery, more on the right, top to bottom feels numb/paralyzed type feeling.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: Er8733), via an unspecified route of administration at age of 39-year-old at arm right on 14Apr2021 12:15 at single dose for COVID-19 immunization. Medical history included high blood pressure. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, clomifene citrate (CLOMID), men's multivitamin, gluco, received within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 10:00, right side of his face was numb, eyes are watery, more on the right, top to bottom feels numb/paralyzed type feeling. Seems to be a Bell's palsy type symptom but no drooping. The adverse events result in doctor or other healthcare professional office/clinic visit. The adverse events result in Emergency room/department or urgent care. The patient underwent lab tests included Curative testing (covid tested): negative on 19Apr2021. The patient was given allergy steroids for events. The outcome of events was recovering.
39 2021-05-16 tremor, pain in extremity 12 Hours after my Husband's second Pfizer shot, he laid down and became incredibly lethargic, confus... Read more
12 Hours after my Husband's second Pfizer shot, he laid down and became incredibly lethargic, confused, delirious, achy, nauseous, and feverish, with shaking and chills. He collapsed when walking to the bathroom in the middle of the night, saying he couldn't breath. He was okay once he laid back down. He stayed in bed for 36 hours. 5 days later he is still fatigued, achy, and has headaches and eye strain, with intense pain in his arm, and a rash covering his body.
39 2021-05-20 brain damage ACCORDING TO DAD, HE GOT THE VACCINE ON 4/28/21. ON MAY 11 HE WAS COMPLAINING OF N/V, LATER HEADACH... Read more
ACCORDING TO DAD, HE GOT THE VACCINE ON 4/28/21. ON MAY 11 HE WAS COMPLAINING OF N/V, LATER HEADACHE AND ALTERED VISION, ENCEPHALOPATHY, CARDIAC ARREST AND DEATH.... AFTER MULTIPLE LOCAL ER VISITS. HE NEVER HAD FEVER. I WAS CALLED ON HIS CASE DUE TO CONCERN FOR CNS INFECTION. HE WAS ADMITTED ON 5/18 AND DIED ON 5/20 THIS MAY OR MAY NOT BE RELATED TO THE COVID VACCINE, BUT IT IS IMPORTANT IT IS REPORTED JUST INCASE IT IS AND MAY HELP SOMEONE.
39 2021-05-21 bell's palsy developed "Bell Palsy" between 48-72 hours after his second shot; This is a spontaneous report from ... Read more
developed "Bell Palsy" between 48-72 hours after his second shot; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 01May2021 10:00 (at age of 39-year-old) (lot number: EW0167) as single dose for covid-19 immunisation. Medical history included high cholesterol. No known allergies. The patient's concomitant medications were none. 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. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in arm left on an unknown date in Apr2021 10:00 (lot number: EW0153) for covid-19 immunization. The patient developed "Bell Palsy" between 48-72 hours after his second shot. The event start date was on 03May2021 14:00. The event resulted in doctor or other healthcare professional office/clinic visit. The event resulted in Emergency room/department or urgent care. No covid prior vaccination, no covid tested post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event included prednisone and valacyclovir. Event outcome was not recovered.
39 2021-05-22 muscle spasms Chest pain lasting 5 days after the first shot, then weaning. Chetry pain returned after the second ... Read more
Chest pain lasting 5 days after the first shot, then weaning. Chetry pain returned after the second dose, still exist on day 4 after vaccination. Shortness of breath occured with both shots. Lightheaded the day following both shots, when doing anything physical. Lasted about 4 days. Second shot caused sporadic muscle spasms throughout the body, shooting pains in random places.
39 2021-05-22 unresponsive to stimuli 39 yo B/M c/o severe headache and blurred vision 5 minutes after receiving the 1st dose of the Pfize... Read more
39 yo B/M c/o severe headache and blurred vision 5 minutes after receiving the 1st dose of the Pfizer vaccine. Patient evaluated by on-site NP and EMS; VS, 12 Lead EKG and IV fluids started. Due to patient not responding and elevated VS, 911 was called; Patient PMHX, PTSD and Anxiety D/O. NKDA; arrived, re-assessed, and transferred PT to Urgent Care for further medical evaluation.
39 2021-05-23 bell's palsy Symptoms consistent with a mild case of bell's palsy. Numbness and tingling in left side of face fro... Read more
Symptoms consistent with a mild case of bell's palsy. Numbness and tingling in left side of face from chin to cheekbone. No drooping in mouth or eye
39 2021-05-23 flushing Numb tongue More flushed than normal skin Allegra administered 0836, vitals obtained. BP 138/86, SPO... Read more
Numb tongue More flushed than normal skin Allegra administered 0836, vitals obtained. BP 138/86, SPO2 96%, P 55. At 0856 patient complained of increased numbness of tongue, vitals signs BP 153/83, SPO2 100%, P 71. Patient remained in no acute distress, no angioedema noted, patient remains without respiratory distress. Patient advised to report to closest Emergency Room. Patient agreed, patient accompanied by wife.
39 2021-05-24 weakness, unresponsive to stimuli Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Mild
39 2021-05-24 weakness Two days after round 2 of vaccine: Severe chest pain and shortness of breath, followed by low energy... Read more
Two days after round 2 of vaccine: Severe chest pain and shortness of breath, followed by low energy and drowsiness. Felt just like Pericarditis that I had back in February. This was confirmed with EKG. Chest X-Ray unremarkable. Pericarditis earlier diagnosed on February 16th, assumed by medical professional that likely had COVID at that time based on recurrence after vaccine. No previous occurrence of Pericarditis prior to Feb 2021
39 2021-05-25 burning sensation, tenderness Pain and burning to back of neck and scalp began on 5.11.2021. Visit to urgent care on 5.14.2021 an... Read more
Pain and burning to back of neck and scalp began on 5.11.2021. Visit to urgent care on 5.14.2021 and prescribed medication for muscle pain (flexeril and motrin) and antibiotic (augmentin) due to enlarged lymph node behind ear and clavicle area. Rash developed to the left side of neck on the evening of 5.15.2021. Returned to Urgent Care on 5.16.2021 and started on Valtrex for shingles. Shingles rash worsened over the following days spreading up on left side of scalp, left side of neck, and down to left shoulder, left side of chest. Rash began to receed on 5.20.2021. On date of report 5.56.2021 slight rash remains to base/back of neck and onto scalp. Pain and burning remain, worsened by pressure/touch and heat.
39 2021-05-26 numbness Patient reported losing feeling in extremities and eyes feeling heavy. Gave dose of benadryl and sy... Read more
Patient reported losing feeling in extremities and eyes feeling heavy. Gave dose of benadryl and symptoms resolved within 5 minutes.
39 2021-05-27 pain in extremity Patient, age 39, states 7 weeks ago (4/11/21) he received the second Covid vaccine in the right arm.... Read more
Patient, age 39, states 7 weeks ago (4/11/21) he received the second Covid vaccine in the right arm. The day after he felt expected malaise and stayed home from work. Day 2-3 it felt sore and warm. It began bothering him more than expected a week later. He describes it as being achy, weak, and sore. 3/10 pain. Denies losing sensation or having numbness. It's hard to pick up a cup of coffee. He can do pretty much everything he did before with this arm but lift weights. He hasn't lifted weights due to the pain, but not weakness. Denies any other symptoms. He controls pain with ibuprofen or aspirin. Patient denies any other illnesses around this time. Patient hasn't received any other vaccines around this time. Patient denies any previous adverse reactions from vaccines.
39 2021-05-28 pain in extremity Arm pain (moderate, resolved within 24 hours.) Dizziness (mild, resolved within 24 hours.) Fatigue (... Read more
Arm pain (moderate, resolved within 24 hours.) Dizziness (mild, resolved within 24 hours.) Fatigue (severe, resolved within 48 hours.) Exacerbation of GERD and nausea (mild, began 72 hours post vaccination, resolved within 5 days of vaccination.) Low grade fever (mild, 2 degrees F above normal basal body temperature for patient, or less - began within 12 hours of vaccination, resolved within 72 hours.) Somnolence (moderate, excessive sleepiness e.g. 3 or 4 hours beyond normal 8 hour sleep requirement daily - began 4 days post-vaccination and resolved within 1 week of vaccination.) Both myself and the older relative who was vaccinated with me (report submitted for them as well, same email address) We still plan to receive our second dose on June 11th and are not concerned by these effects. We will report any additional effects with the second dose as well, in hopes that they are useful data.
39 2021-05-31 numbness, tingling, burning sensation Tingling, burning sensation, numbness in half of face. Same side as injection, left. Same sensation ... Read more
Tingling, burning sensation, numbness in half of face. Same side as injection, left. Same sensation in left forearm and hand.
39 2021-05-31 unresponsive to stimuli Patient went completely white, head went down and his cell phone that he was holding fell to the gro... Read more
Patient went completely white, head went down and his cell phone that he was holding fell to the ground. We asked him multiple times, Sir, are you okay? With no response. We immediately called ED.
39 2021-06-01 numbness, tingling This is a spontaneous report from a contactable consumer (Patient himself). A 39-year-old male consu... Read more
This is a spontaneous report from a contactable consumer (Patient himself). A 39-year-old male consumer received bnt162b2 (BNT162B2, COVID-19 VACCINE; formulation: Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on Friday, 21May 2021 (at the age of 39-years-old) as Unknown dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On the day of vaccination, he felt a slight numbness of the face, on the right side, above the eyebrow and the outside corner of eye and ending up in the jaw, he was let it go at that time when he leaving the vaccination center, But these days he felt that tingling or numbness again. Also felt tingling in hand. Patient was asked whether any reports on this. Events were considered as non serious. The outcome of the both events was reported as not recovered. Information about lot/batch number has been requested.
39 2021-06-02 depressed level of consciousness, feeling cold he may pass out; feeling cold; chills; high heart rate; headache; palpitations; dizziness; Sweating;... Read more
he may pass out; feeling cold; chills; high heart rate; headache; palpitations; dizziness; Sweating; like a panic attack; got more anxious and scared; This is a spontaneous report from a Pfizer Sponsored Program. A 39-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Apr2021 12:30 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 39 years). The patient's medical history and concomitant medications were not reported. The patient states he took the shot at 12:30PM and came out of the technician's room, sat on the chair, and at that time, a minute after, the first thing he developed was dizziness, he started with dizziness, followed by palpitations and sweating and chilling, then headache and then he started a little bit of panic, like a panic attack, a lot of people gathered around him, he was scared because of it, and then the technician came out and mentioned he needed to go to the ER as soon as possible or he may pass out, he is unsure what she meant, but it scared him more (all on 25Apr2021). At the time he took the vaccine, 3 days before the vaccine came, his father, who is not in the US, but back home, his father was tested positive for corona, was in ICU at the time of caller's vaccine, so caller was stressed for 3-4 days before the vaccine, but at that time didn't feel like complete anxiety like when he took the vaccine, he was fine, not scared, but was 100% fine, not scared, then took the shot, started symptoms, got more anxious and scared and when people gathered, sometimes he felt totally stressed out because of his father. At the same time, if you are anxious and scared your heart beat can be high but not that high, his heart beat was 164 the other day, not the same, day, but after 24 hours. 25th was when he had the shot, 26Apr2021, at 1PM he was talking to someone on the phone, felt chills and right away his heart beat went from 120-140, he took water and sat down, walked a couple steps and picked up his oximeter and checked his oxygen and his heart rate was 120 to 130 to 140 then 160, and he sat down, took water and relaxed, it dropped down to 120, was 120-130 some time for 15-20 minutes then 911 guys came, took him to the hospital, and by the time he was at the hospital he was in the 100s. Feeling cold and chilling outcome: He was feeling cold chills, is now pretty much normal, sometimes he feels chills because he is in a T-shirt, he was fine going into the room taking the vaccine, when he came out, the first symptoms he started feeling was dizziness and feeling like falling down. High heart rate: was only those instances for 2 days, on the 25th and 26th for a little time, 15-20 minutes each day, after that he went to the cardiologist, who put a heart rate meter on his chest and observed his rate for 24 hours, and beat, and took a heart ultrasound and bloodwork and all his blood is fine and his heart rate is fine, after that he visited 3 times the cardiologist, who said his beat was fine and function was fine, and he was healthy and his physician after checking the report, she said the blood reports pretty much were normal. All the events occurred on 25Apr2021 and patient had an emergency room visit for all of the events and had a physician office visit for the event high heart rate. The patient underwent lab tests and procedures which included blood work: normal, heart rate: normal, heart rate: 100-160 and heart ultrasound scan: normal on an unspecified date. Outcome of the event Depressed level of consciousness was recovered on an unspecified date while outcome of the event heart rate increased was recovered on 26Apr2021. Outcome of the events panic attack and anxious mood was recovered on an unspecified date in 2021. Outcome of the remaining events was recovered on Apr2021. Information on the lot/batch number has been requested.
39 2021-06-03 weakness 39 y/o with past medical history of Hypertension that presents with feeling weak, nervous and concer... Read more
39 y/o with past medical history of Hypertension that presents with feeling weak, nervous and concerned for BP post vaccination. Patient states that this is the first vaccination in the two-dose series. Patient denies previous vaccination reaction. Patient states that the vaccination was received in the left arm. Patient placed in wheelchair and taken to the partitioned area with the NP and Paramedics. Patient initial vitals all within normal limits, 125/92 BP, 97 HR, 98 %RA, 12 Resp. Patient provided a bottle of water and monitored for 15 mins. Patient states that is feeling better and that feels that it was just nervousness. Patient vitals reassessed and normal, 127/85 BP, 98 HR, 99% RA, 12 Resp. Patient discharged in stable condition, ambulated without difficulty. NP encouraged patient to hydrate well since patient will be going back to work in an outdoor environment.
39 2021-06-05 tremor, feeling jittery Almost 11 hours I began to have controllable body tremors. I could not keep my hands steady. Entire ... Read more
Almost 11 hours I began to have controllable body tremors. I could not keep my hands steady. Entire body was in this state of shaking jitters. Then severe pain in all joints for duration on 24 hour period. Ankles, toes, fingers wrists. Felt like burning deep pain. All subsided by taking both Tylenol and Advil within 24 hours.
39 2021-06-06 feeling hot, tingling PT received 1st dose of Pfizer and within 5 minutes felt warm/sweaty, fingertips tingling, then expe... Read more
PT received 1st dose of Pfizer and within 5 minutes felt warm/sweaty, fingertips tingling, then experienced near syncope with injury. PT was assisted to the floor for rapid recovery. He was then taken to MED OBS 1. PT reported eating and drinking little today despite working outside. No history of similar evets. PT recovered with the intervention.
39 2021-06-08 feeling cold, tingling Within 2 min of vaccine, experienced tingling over back of hands and nose, with cold sensation on ba... Read more
Within 2 min of vaccine, experienced tingling over back of hands and nose, with cold sensation on back, and face itching. Then 30 min later, had itching in throat. Administered Benadryl 50 mg and within 30 min, patient reported resolution of symptoms.
39 2021-06-09 bell's palsy Bells Palsy
39 2021-06-09 pain in extremity sore arm; mild headache; This is a spontaneous report from a contactable consumer reporting for hims... Read more
sore arm; mild headache; This is a spontaneous report from a contactable consumer reporting for himself. A 39-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202 (EN6200: as reported in field)), via an unspecified route of administration, administered in Left Arm on 05Mar2021 at 11:45 as single dose for COVID-19 immunization. The patient's Medical history included High blood pressure, and overweight. The patient did not have COVID prior to vaccination. The patient did was not tested for COVID post vaccination. The patient did not take any other vaccine 4 weeks prior to COVID vaccination. The patient's concomitant medications included paracetamol (TYLENOL), ibuprofen, tadalafil (CIALIS), probiotics, and lisinopril. On 05Mar2021 at 13:00, the patient experienced sore arm, and mild headache. Therapeutic measures were taken as a result of events: treatment included Tylenol and Ibuprofen. The outcome for the events was resolved approximately on an unknown date in Mar2021. No follow-up attempts are possible. No further information is expected.
39 2021-06-13 weakness, unresponsive to stimuli, flushing Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medi... Read more
Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
39 2021-06-17 bell's palsy Patient presented to ED on 5/12/21 with Bell's palsy. Reported symptoms started 5/9/21. Initial sym... Read more
Patient presented to ED on 5/12/21 with Bell's palsy. Reported symptoms started 5/9/21. Initial symptoms was loss of taste.
39 2021-06-17 pain in extremity, bell's palsy Bell's palsy; sore arm; This is a spontaneous report from a contactable consumer (patient). A 39-yea... Read more
Bell's palsy; sore arm; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0151), via an unspecified route of administration on 14Apr2021 at 11:00 (at the age of 39-year-old), as 2nd dose, single dose in right arm for COVID-19 immunization. The patient's 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: ER8727), via an unspecified route of administration on 24Mar2021 as single dose in left arm for COVID-19 immunization. On 14Apr2021, after the second shot of vaccine, the patient experienced a sore arm. Patient felt sore arm for 2-3 days and then recovered completely. On 31May2021 Monday, morning around 07:00 or 08:00, the patient visited Emergency room because he thought he was having a stroke. But it was not stroke, and the ER told him he had Bell's Palsy. Patient thought it was a side effect and was given with medication for the event but was not able to afford it. The patient was not under any medications before the vaccine, but he continued medications for Bell's Palsy. Patient has not received any vaccines since the Pfizer vaccine. The clinical outcome of the event Bell's palsy was resolving, and the clinical outcome of the event sore arm was resolved on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
39 2021-06-24 weakness After receiving the first Pfizer vaccine, the patient started to suspect that he was going to experi... Read more
After receiving the first Pfizer vaccine, the patient started to suspect that he was going to experience an epileptic event related to the vaccination administration. The patient screamed, and upon assessment the patient's eyes were pointing up and I could see the whites of his eyes, and felt like he was going to vomit. The patient appeared to be oriented. The patient's blood pressure and HR were taken, found to be within BP 133/90 HR at 124. The patient appeared anxious and said that he was "seeing red", and continued to appear restless. The patient stated "I am going to have an event" and "I think I'm having blurry vision". EMS called while this RN comforted the patient during this time and appeared to become calm. Prior to EMS arrived, the patient stated "My body is moving and I'm not doing anything". The patient was encouraged to lay down on the floor as he stated that he felt weak, stated he was having chest pain, and continued to experience intermittent blurry vision. EMS arrived at 1213 and he was assessed. EMS suggested that walking over to the emergency department,and the patient agreed. The patient and son were escorted to the ED triage desk by this RN via wheelchair. On arrival to ED Pt left stating "I feel better and I'm gong to eat some food and come back" Did not return
39 2021-06-27 feeling of body temperature change, cold sweat, tenderness, pain in extremity Day 1: Within 1 hour of shot, feelings of delirium and low-grade fever (99 F), posterior neck pain a... Read more
Day 1: Within 1 hour of shot, feelings of delirium and low-grade fever (99 F), posterior neck pain and stiffness. 4 hours after shot, arm pain (significantly less than with first dose). Chills. Joint pain (fingers, knees, hips). Mild headache. After 8 hours, chills and fever subsided, but hot; sweaty. General fatigue. At 12 hours, worsening but intermittent finger, hand and knee tenderness. Clamminess, sweats, intolerance to both heat and cold. Eye sensitivity. Day 2: Severe body aches. Mild asthma exacerbation (effectively alleviated with albuterol sulfate inhalation). Severe fatigue. Description was, "like having just gotten out of a pool, but whole body instead of just swimsuit being wet." Light sensitivity/aversion with dull headache. Difficulty concentrating. Elbow joint paint. Fever. Day 3: Significantly reduced headache, fever and body "heaviness." Pain in legs and elbows improved or eliminated. Gastric and esophageal inflammation. Diarrhea; stomach bloating; nausea; gas; gastritis. Mild. Esophageal and splenic discomfort (upper-left quadrant tenderness). "Brain fog" persists. Better than previous day. Forgetfulness. Insomnia. Day 4: Significantly reduced symptoms. Pain virtually gone. Gastric symptoms persist, but reduced. Somnolence. Day 5 - 7: Complete improvement, however notable axial (underarm) lymph swelling and tenderness. Day 7 - 14: Resolution of all symptoms, mild lymph swelling persists. Day 17: Lymph swelling resolved.
39 2021-06-28 feeling hot History 39-year-old male patient with a past medical history significant for obstructive sleep apnea... Read more
History 39-year-old male patient with a past medical history significant for obstructive sleep apnea and anxiety presents with chief complaint of feeling dizzy, chest burning, and lightheaded shortly after receiving his first Covid vaccine here in the hospital. He states he waited for the designated amount of time to be observed and then walked out of the hospital and got into his vehicle. As he was leaving the parking lot he felt like he was going to pass out. He states things were spinning and he felt lightheaded. He developed a warm feeling from the lower abdomen up into his chest. He states he felt like he had some chest pressure. States he continues to feel lightheaded and has burning in his chest. Pati
39 2021-06-29 numbness Numbness in the left side of my face as well as both of my lips; Muscle pain all over body; Joint pa... Read more
Numbness in the left side of my face as well as both of my lips; Muscle pain all over body; Joint pain all over body; Headache; Elevated temperature of around 99 degrees; Chills; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) in left arm on 19Mar2021 at 10.45 am as a single dose (at the age of 39 years) for COVID-19 immunisation. Medical history included hypertension and obesity. Concomitant medication included blood pressure medication (not mentioned name of the medication). 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 had not tested for COVID-19. On 19Mar2021 at 19:45,the patient experienced numbness in the left side of my face as well as both of my lips, muscle pain all over body, joint pain all over body, headache, elevated temperature of around 99 degrees and chills. 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 event. The clinical outcome of the events numbness, muscle pain, joint pain, headache, elevated temperature and chills was still recovering at the time of the reporting. No follow-up attempts are possible. No further information is expected.
39 2021-06-29 pain in extremity, weakness just tired; nausea; gas along with weakness; Gas along with weakness; chills; joint pain in knees; A... Read more
just tired; nausea; gas along with weakness; Gas along with weakness; chills; joint pain in knees; Arm Soreness; Midnight Fever developed; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old male 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 17Mar2021 at 15:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19. Concomitant medications included Lisinopril/HCTZ (MANUFACTURER UNKNOWN) 20-25 mg from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 24Feb2021 at 15:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. On 17Mar2021, the patient experienced arm soreness that started and worsened at 20:00, joint pain in knees at 20:45, chills at 22:00 and at midnight fever developed. On 18Mar2021, the patient experienced nausea and gas along with weakness at 02:00, 103 (unspecified units) fever at 04:00, which was still bad at 06:00; fever falling strength recovery at 08:00, just tired and arm sore at 10:00, was same at noon and 14:00 and at 16:00, just the arm for another 24 hours. 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 joint pain in knees, chills, fever, nausea, gas, weakness, fever, pain in arm and tiredness was recovered on an unknown date. No follow-up attempts are possible. No further information is expected.
39 2021-06-29 pain in extremity stomach pain; severe diarrhea; Fatigue; Sore arm; headaches; This is a spontaneous report from a con... Read more
stomach pain; severe diarrhea; Fatigue; Sore arm; headaches; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8727), via an unspecified route of administration in the right arm on 19Mar2021 at 08:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. The patient medical history included milk sensitivity. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested positive for COVID-19. The patient did not take other medications within the two weeks of vaccination. On 20Mar2021 (day1), the patient experienced sore arm and headaches. On 21Mar2021 at 08:00 (day 2), the patient experienced stomach pain, severe diarrhoea and fatigue. 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 sore arm, headaches, stomach pain, severe diarrhoea and fatigue was resolving at the time of report. No follow-up attempts are needed. No further information is expected.
39 2021-07-01 feeling hot This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patie... Read more
This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received 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 left arm shoulder on 08Feb2021 at 14:00 (at the age of 39-year-old) as dose 1, single to protect his family and himself from COVID/ COVID-19 immunisation. The patient's medical history included ongoing vertigo. He has had vertigo in the past due to concussion, but that was a while back. Maybe 7 or 8 years ago. Concomitant medications was none. Family medical history relevant to adverse events was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Prior vaccinations (within 4 weeks) was none. Adverse events following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was none. It was reported that, patient confirmed vaccine as COVID-19 vaccine. He received it at Pfizer site. It was reported that, he just had vaccine yesterday the first dose. Pfizer vaccine. He was calling to report side effects. After the injection on 08Feb2021, within an hour, he started feeling like his body was hot. Then he started feeling dizzy, vertigo around four hours after vaccination on 08Feb2021. Vertigo was worse today. Dizzy was reported as worsened. Weight was 170 to 180 pounds. The adverse events did not require a visit to emergency room and physician office. No investigation assessment. The outcome of the event body was hot was resolved on 08Feb2021 and not resolved for the other events. Follow-up attempts completed. No further information expected.~
39 2021-07-03 seizure Dizziness, Seizure, chills, nightmares and headache
39 2021-07-08 tingling, weakness Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Mild, Systemic: Body Aches General... Read more
Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild, Systemic: Joint Pain-Mild, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild
39 2021-07-09 facial paralysis, bell's palsy Bell's Palsy, facial droop, facial paralysis. Treatment: predniSONE (DELTASONE) 60mg Time course: P... Read more
Bell's Palsy, facial droop, facial paralysis. Treatment: predniSONE (DELTASONE) 60mg Time course: Prescribed for 7 days. Referred to PCP for follow up
39 2021-07-11 pain in extremity, numbness, tingling The patient began to experience numbness; Tingling in the left arm; Aching in left hand; This is a s... Read more
The patient began to experience numbness; Tingling in the left arm; Aching in left hand; This is a spontaneous report from a non-contactable health care professional. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration on 22Mar2021 (at the age of 39-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had previously received PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 39-year-old) as dose 1, single for COVID-19 immunisation. During his 15-minutes waiting period after the injection, the patient experienced numbness and tingling in the left arm and aching in left hand on 22Mar2021. He denied rash, hives, difficulty breathing, wheezing and light headedness. The patient had no daily prescription medications for numbness and tingling of left arm/hand. The patient did not receive any treatment for events. Follow up response to treatment was good (as reported). The patient was discharged to home as stable. The outcome of the events numbness and tingling in the left arm and aching in left hand were resolved in Mar2021. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Historical vaccine details (39 years added as age/units) and leading sentence updated to a non-contactable health care professional.
39 2021-07-12 weakness Feels weak; No appetite; Short of breath/Winded going up and down stairs; This is a spontaneous repo... Read more
Feels weak; No appetite; Short of breath/Winded going up and down stairs; This is a spontaneous report from a non-contactable consumer. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 24Mar2021 as a single dose (at the age of vaccination 39-years-old) for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to vaccination, it is unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced short of breath (2 days after shot, felt short of breath, after moving equipment, had to sit for 10 mins and just catch breath) and on 28Mar2021, the patient was feeling weak, winded going up and down stairs and did not have appetite. Considered going to hospital for IV fluids. It was unknown if the patient had received 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 short of breath/winded going up and down stairs, feels weak and no appetite was unknown at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
39 2021-07-14 numbness Ash had COVID-19 Pfizer vaccination at his local pharmacy on June 17, 2021. He had significant pain... Read more
Ash had COVID-19 Pfizer vaccination at his local pharmacy on June 17, 2021. He had significant pain at the injection site, followed that evening by numbness of his left thumb. The numbness involves the tip of his finger, with worsening intensity. Over the next few days, the numbness progressed to involve also the left forearm. Patient did not have any neck pain or headaches. The pain at the injection site lasted more than 10 days. On June 28, he was evaluated by orthopedics at hospital MD. An EMG done revealed significant nerve conduction delays consistent as per the report with brachial plexopathy. The report was read to me by client as I do not have access to the document. He was given oral steroids without significant improvement. The pain at the injection site is gone. His numbness persists.
39 2021-07-16 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted ~ 1 minute after vaccine, episode lasted ~30 seconds. Pt laid on floor for ~10 minutes afterwards and then sat in chair for 20 minutes. Pts blood pressure taken and monitored.
39 2021-07-19 numbness The day after his second dose, he felt malaise, severe headache. His left side of the face develope... Read more
The day after his second dose, he felt malaise, severe headache. His left side of the face developed numbness, he had hearing loss, and worsening tinnitus. He has existing tinnitus and hearing issues and was objectively evaluated by audiology within 2 days, and found to have found significant worsening. It began slowly resolving over a few days to weeks. It is still being evaluated for potential other causes such as intracranial tumor or cochlear stroke.
39 2021-07-21 facial paralysis, bell's palsy I got a bell's palsy; I started left cheek completely you know got little paralyzed so on Wednesday ... Read more
I got a bell's palsy; I started left cheek completely you know got little paralyzed so on Wednesday I got a little severe; This is a spontaneous report from a contactable consumer. This 39-year-old male consumer (patient) reported himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0198) via an unspecified route of administration on 02Jul2021 on left arm (at 39-years-old), as dose 1, single for COVID-19 immunization. The patients medical history was not reported. It was mentioned that patient had no other medical condition, did not use concomitant medication. On 05Jul2021, after vaccination he got a bell's palsy after that from Monday onwards, his left cheek completely got little paralyzed so on Wednesday he got a little severe and went to the emergency, he went to normal physician first and then they send him to the emergency and then he got the CT scan and then they basically found him diagnosed with bell's palsy, one of the side effect and currently they have put him on the medication which was a steroid. He wanted to report it and at the same time he would like to see, what was the assistance that Pfizer was providing. When paraphrased the concern, Consumer stated, that he was taking it right now, every day they prescribed me to take this steroid Prednisolone, 60 mg, you know for next one week. The outcome of the events was not recovered. Follow-up attempts were completed. No further information was expected.
39 2021-07-21 numbness 7 DAYS POST-ADMINISTRATION, HALF OF PT'S FACE WAS SWOLLEN WITH NO SENSATION. EXPERIENCED SUDDEN SHAR... Read more
7 DAYS POST-ADMINISTRATION, HALF OF PT'S FACE WAS SWOLLEN WITH NO SENSATION. EXPERIENCED SUDDEN SHARP HEADACHES, CHEST PAIN
39 2021-07-25 pain in extremity On 4/11/2021, i was sitting and having coffee when i started get a lot of pain on the left side of m... Read more
On 4/11/2021, i was sitting and having coffee when i started get a lot of pain on the left side of my chest which was radiating in my lower back and in my left arm. Initially i though it was acidity related so i had a cup of cold milk to reduce the symptoms. However the pain did not stop and it did not feel like the indigestion discomfort. The symptoms looked like very classic heart related issue symptoms, so my wife drove me to the ER immediately.
39 2021-07-27 pain in extremity Retaining water; Legs are swollen, feel heavy, ache.; Legs are swollen, feel heavy, ache.; Legs are ... Read more
Retaining water; Legs are swollen, feel heavy, ache.; Legs are swollen, feel heavy, ache.; Legs are swollen, feel heavy, ache.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 26Apr2021 at 12:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. It was unknown whether the patient had any known allergies. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), glucosamine (MANUFACTURER UNKNOWN) and testosterone supplement (MANUFACTURER UNKNOWN), all were taken for unknown indication on an unknown date. 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 at 00:00, the patient experienced retaining water, legs swollen, feel heavy and ache. It was unknown whether the adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether the patient had received any treatment for the reported events. The clinical outcome of the events retaining water, legs swollen, feel heavy and ache was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
39 2021-07-28 depressed level of consciousness 39 Male tested positive 6/4/2021. Vaccinated with Pfizer 12/22/2021 & 1/12/2021. 6/4/2021 hospital a... Read more
39 Male tested positive 6/4/2021. Vaccinated with Pfizer 12/22/2021 & 1/12/2021. 6/4/2021 hospital admission for tracheo-esophageal fistula (TEF) transfer from hospital. Diminished breathing sounds, minimally conscious. Removed from ventilator support 6/17/2021. Problems at time of death 6/19/2021 - chronic respiratory failure, COVID-19, history of severe TBI, TEF, trach vent/PEG dependent.
39 2021-07-28 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Additional Details: 911 was calle... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Additional Details: 911 was called patient refused treatment.