Pfizer

Nervous system symptom reports

Male, 60 - 75 years

Age Reported Symptoms Notes
60 2021-01-07 hot flush Approximately 2 hours after receiving the vaccine I felt a heat flash, people setting in the area as... Read more
Approximately 2 hours after receiving the vaccine I felt a heat flash, people setting in the area asked if I was OK as my face was red. It cleared in approximately a minute. The 2nd heat flash came on about 5 to 10 minutes later and cleared about a minute later. The 3rd heat flash came on about another 5 to 10 minutes, again clearing at about 1 minute. Next I felt like my head was in a fog, found it very hard to focus, and was forgetting what I was doing. I walked over to the office, my supervisor asked if I was ok as she said it looked like my eyes were glazed over, my head was still in a fog. This cleared by 2:30 p.m.
60 2021-01-07 hot flush Approximately 2 hours post vaccination a heat flash came over my body, co-workers setting around me ... Read more
Approximately 2 hours post vaccination a heat flash came over my body, co-workers setting around me asked if I was ok as my face was red, cleared about 1 minute later. About 15 minutes later a 2nd heat flash came over my body and cleared about 1 minute later. About 15 minutes later the 3rd heat flash came across my body and cleared about 1 minute later. Approximately 30 minutes later my head was in a fog, I could not focus, thoughts left my mind. When returning to my office my manager asked if I was ok and said my eyes were glossed over and my face was red. All this cleared around 2:30 pm.
60 2021-01-07 night sweats Fever; He sweated the whole night; He slept for 24 hours and that is abnormal; This is a spontaneous... Read more
Fever; He sweated the whole night; He slept for 24 hours and that is abnormal; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Batch number: 20201221E; Expiration date was not reported) on 21Dec2020 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included previously having COVID-19 from Oct2020 to an unspecified date; abnormal cholesterol; and abnormal blood pressure. Concomitant medications included acyclovir [aciclovir] (ACYCLOVIR); atorvastatin for abnormal cholesterol; hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS) for abnormal blood pressure; and vitamin D NOS. On 22Dec2020, the patient had fever. In Dec2020, the patient had sweated the whole night; and had slept for 24 hours and that was abnormal. The patient had body temperature values of 101.4 to 101.6 degrees Fahrenheit on 22Dec2020; and 98.8 to 99.9 degrees Fahrenheit on 23Dec2020. The patient had received ibuprofen (MOTRIN) and paracetamol (TYLENOL) as treatment for the fever. The patient considered his adverse reaction "mildish". The outcome of the events was recovered on 22Dec2020 (21:00) for 'fever'; and was recovered in Dec2020 for 'sweated the whole night' and 'slept for 24 hours and that was abnormal'. The reporter's assessment on the causal relationship between the vaccine and the event was related.
60 2021-01-07 pain in extremity Dizziness, Headache, Arm sore and painful. C/O feeling eye pressure
60 2021-01-10 pain in extremity pt states experienced headache, soar throat, bone pain to (R) hand, chills, and low grade fever onse... Read more
pt states experienced headache, soar throat, bone pain to (R) hand, chills, and low grade fever onset night of vaccination lasting 2-3 days
60 2021-01-17 bell's palsy Ear ache Bells Palsy, given steroids, prednisone 50mg oral tablet, 5 days
60 2021-01-18 numbness WHEN I RECEIVED THE PFIZER -BIONTECH COVID-19 VACCINE THE NEXT 2 DAYS 12: 45 AM I TOOKA SHOWER AND ... Read more
WHEN I RECEIVED THE PFIZER -BIONTECH COVID-19 VACCINE THE NEXT 2 DAYS 12: 45 AM I TOOKA SHOWER AND WENT TO BED THEN I FOUND MY LEFT SIDE OF THE BODY FROM MY AMPIT ALL THE WAY TO MY FEET ARE NAMBED AND ALSO SOMETIMES MY LEFT LEG GIVE UP ON ME FEELS WEEK ON MY KNEE. I WENT TO MY DOCTOR AND ALSO I CONTACTED MY WORK PLACE THAT IS EMPLOYEE HEALTH AND THEY TOLD ME TO CALL THE AGENCY.
60 2021-01-18 tremor I had fever and severe chills/ shaking
60 2021-01-18 unresponsive to stimuli Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient... Read more
Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient presented to Urgent Care on 15-Jan-21 complaining of left sided chest pain that started the evening before with an associated slight cough. Pt was afebrile with a heart rate of 88 and an O2 sat on room air of 98% in triage. His EKG showed a sinus tachycardia of 114 with a slightly prolonged QTc of 463 ms. Physical exam was significant for bibasilar crackles and X-ray showed bibasilar infiltrates consistent with COVID pneumonia but bacterial pneumonia could not be excluded. The patients BP was documented as 97/64. He was treated with Zofran for nausea and tylenol. He was prescribed a five day course of Azithromycin, an Albuterol inhaler, guaifenessin with codeine cough syrup, and Zofran. Labs were drawn and he was discharged. His lab results were reported after his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes, an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit was reported as negative and a swab performed at his employment on 13-Jan-21 was also reported to be negative. Patient could not be reached by phone after discharge from Urgent Care about these labs. On the evening of 16-Jan-21, Police Department received a 911 call about an adult at the patient's address who was found unresponsive. Upon arrival on scene, the patient was found to be deceased and a decision was made not to attempt to resuscitate. The death was deemed to be non-suspicious and the patient's body was transported to a funeral home. On 19-Jan-21, I contacted the State Medical Examiner's Office. They have decided to perform an autopsy and have recovered the CBC and chemistry specimens obtained for further testing.
60 2021-01-19 numbness I received my 1st shot and 2 and a half weeks now, I have numb finger tips on several fingers. I am... Read more
I received my 1st shot and 2 and a half weeks now, I have numb finger tips on several fingers. I am making a Dr. appointment.
60 2021-01-19 pain in extremity MODERATE PAIN IN LOWER EXTREMITIES (FOCUSING ON HIPS/KNEES). TO TREAT: LOCAL WARMTH, FLUIDS, IBUPROF... Read more
MODERATE PAIN IN LOWER EXTREMITIES (FOCUSING ON HIPS/KNEES). TO TREAT: LOCAL WARMTH, FLUIDS, IBUPROFIN.
60 2021-01-21 feeling of body temperature change 1/19 2300- INJECTION SITE DISCOMFORT 1/20 0100- FEELING OF FEVER, BODY ACHES, SORE THROAT 0830- NAUS... Read more
1/19 2300- INJECTION SITE DISCOMFORT 1/20 0100- FEELING OF FEVER, BODY ACHES, SORE THROAT 0830- NAUSEA, FATIGUE 1050- TEMP 100.4. TOOK TYLENOL 1000MG @ 0100 AND @1030
60 2021-01-22 tremor Shakes headache nausea sweats for 7 days weight loss
60 2021-01-23 weakness Patient experienced fever 103 degrees, body and muscle aches, chills, ringing in the ears, headache... Read more
Patient experienced fever 103 degrees, body and muscle aches, chills, ringing in the ears, headache, loss of appetite. Dr. suggested Tylenol and fluids for treatment. Spent 24 hours in bed as I had no energy.
60 2021-01-24 facial pain Elevated blood sugar, unable to get it under control. Right side of skull and face extremely painful... Read more
Elevated blood sugar, unable to get it under control. Right side of skull and face extremely painful, including tongue lips, teeth eye, skin. Some soreness continued after 2 days.
60 2021-01-24 pain in extremity Pt received the 2nd dose of the COVID vaccine on Sunday 1/17/21 and developed a sore arm, but otherw... Read more
Pt received the 2nd dose of the COVID vaccine on Sunday 1/17/21 and developed a sore arm, but otherwise had no symptoms. By Tuesday 1/19/21, he was having shooting pains through his shoulder and down to his elbow. By late Wednesday, he had started to develop hives on his palm, between his fingers, and up to the elbow. Pt states he has a history of a pinched nerve in his neck and elbow, but this pain is nothing like his usual pain. On 1/22, pt presented to the ED for left uper arm pain and rash. He denied new detergents, foods, clothes, wooded area exposure. Denied decreased ROM in shoulder, but ROM makes his shoulder sore. BP 161/82, otherwise vitals normal. Rash did not apear infectious. No evidence for DVT. Pt received ketorolac 30 mg IM x 1 in ED and was prescribed hydrocodone-APAP 5-325 mg tabs PO Q6h PRN #8. Pt was instructed to follow up with PCP in 1-2 days. By 1/25/21, pt reports the hives have become dark purple, like bruises. He states he has trouble making a fist and is not using his left arm at all - when this writer spoke to him, he said it was "gimpy." Pt stated during the phone call that he was about to call his PCP for a follow up appointment.
60 2021-01-25 pain in extremity Received vaccine at 10:44am. My arm was a little sore almost immediately. Approximately 12:30-1:00pm... Read more
Received vaccine at 10:44am. My arm was a little sore almost immediately. Approximately 12:30-1:00pm, I started getting a bit nauseated, pit in my stomach . Lasted until went to bed around 9:00pm. In morning felt fine except my arm felt much more sore at the shot point for about 2-3 hours after I woke up. 10:00am everything is normal.
60 2021-01-28 discomfort This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: Apr2021), via an unspecified route of administration on 12Jan2021 08:00 at a single dose on left arm for COVID-19 immunization. Medical history included diabetes, stent, and cholesterol. Concomitant medication included metformin for diabetes, atorvastatin from 2009 (also reported as Jan2020) for cholesterol, ticagrelor (BRILINTA, NDC: 01860776-60, LOT: MM0189, EXP: Apr2023), saxagliptin hydrochloride (ONGLYZA, NDC: 0310-6105-90, LOT: MJ0731, EXP: Feb2023) for diabetes, and terbinafine. The patient experienced felt bad the first day, chills, wooziness/ woozy, felt wobbly all on 12Jan2021. Then experienced feeling like has a big weight on him, blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96/ checked his blood sugar again later and it was 153, which is not through the roof on 14Jan2021, and he is real tired on Jan2021. Patient says he got the Pfizer vaccine, clarified to Pfizer BioNTech COVID-19 vaccine, a couple days ago and the first day he felt bad and had chills and felt wobbly and woozy. He says yesterday (13Jan2021) he felt pretty good, and even worked out. He says he also worked out today, but he has had chills and feels like he has a big weight walking on him, he doesn't know the right word. He says he is also a diabetic, and he noticed today that his blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96. He says he is careful with his diet and eats the same thing. He says he hasn't taken his meds today, and he checked his blood sugar again later and it was 153, which is not through the roof, even without his medication so he would like to know does the vaccine affect your blood sugar? He says he got his first dose of the vaccination on Tuesday at 08:00AM, in his left arm. He clarifies that he has had chills today and then feels like there is a big heavy weight on him, he is real tired and his sugar is low, that was odd. The outcome of the events was unknown.
60 2021-01-28 feeling cold Muscle aches, fever, diarrhea, really bad chills, headache
60 2021-01-30 bell's palsy Developed Bell?s Palsy
60 2021-02-02 bell's palsy, facial paralysis Bell's palsy On 1/11 Patient began experiencing tingling in his left jaw On 1/18 he began experien... Read more
Bell's palsy On 1/11 Patient began experiencing tingling in his left jaw On 1/18 he began experiencing aches in his teeth On 1/22 paralysis of L side of his face, did not spare the forehead
60 2021-02-12 inability to speak, grand mal seizure Seizures Narrative: Hospital employee found aphasic & altered gaze, then tonic-clonic seizure witne... Read more
Seizures Narrative: Hospital employee found aphasic & altered gaze, then tonic-clonic seizure witnessed. Employee intubated in internal ED. Employee drank 1/2-1 gallon Vodka, last drink 24 hours prior to onset. Employee has history alcohol-induced seizure.
60 2021-02-17 weakness Double Covid Pneumonia; feeling tired; weak; doctors were concerned that the Covid vaccine had taxed... Read more
Double Covid Pneumonia; feeling tired; weak; doctors were concerned that the Covid vaccine had taxed his immune system; This is a spontaneous report from a contactable consumer (patient; a direct care staff for a group home). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 613247, expiration date: May2021), intramuscularly to the left arm on 21Jan2021 at 0.3 mL, single for COVID-19 immunization. He was given the vaccine at work. It's a group home facility. The patient's medical history included high blood pressure, and positive for the covid virus from 09Jan2021 to an unknown date. Concomitant medication included benazepril from 22Jan2021 and ongoing for high blood pressure. He saw a doctor on 22Jan2021 and he prescribed Benazepril; it was started on 22Jan2021. The patient previously received a flu vaccine on Sep2020 for immunization. The patient called about the Covid vaccine. He reported that on 09Jan2021, he was positive for the COVID virus. He was then cleared on 16Jan2021 to go to work. His work then offered the COVID vaccine on 21Jan2021 and he got it. Then on 29Jan2021, he was diagnosed with Double Covid Pneumonia. His doctors were concerned that the Covid vaccine had taxed his immune system. The patient was a direct care staff for a group home. He cares for adults that are developmentally challenged. He has a CPR license. The patient confirmed that he received his first dose of the vaccine on 21Jan2021. He started feeling tired and weak about evening of 22Jan2021. He then started feeling out of breath Wednesday 27Jan2021, 28Jan2021 Thursday, and Friday 29Jan2021. He thought maybe he might be having a normal side effect. He stated that the Double Covid Pneumonia was detected on the X-ray that took place on the 29Jan2021. He is scheduled for second dose on 11Feb2021. The patient stated that the weakness was horrible. They gave him antibiotics; he was starting to recover. He was off of work till Saturday due to the pneumonia. He doesn't know if he will be getting the second dose. The patient was prescribed antibiotic Cefuroxime Axetil 500mg 1 tablet by mouth twice a day for 7 days, antibiotic Doxycycline Monohydrate 100mg 1 tablet by mouth twice a day 7 days, a Steroid Prednisone 20mg 2 tablets by mouth daily at same time in morning for 5 days, and a breather Albuterol HFA 90mcg/att inhale 2 puffs by mouth every 4 hours as needed for shortness of breath, wheezing, or cough. It was reported that they did a Covid Nasal Swab Test on 09Jan2021, then on that Sunday or Monday he got positive result, and by that time he had fatigue. After he got the vaccine, he went back to work. After the vaccine, it was a big surprise about the double Covid pneumonia, and they think it was taxing the immune system. He has had no issues with vaccines in the past. He had a Flu vaccine recently and there was no problem, that was Sep2020. He wants to know should he get the second dose.The outcome of the events double Covid pneumonia and "doctors were concerned that the Covid vaccine had taxed his immune system" was unknown. Regarding his double Covid pneumonia, the doctor said his O2 level will determine how he is doing. They will also do another lung X-ray. The doctor said the antibiotic should take care of it. The doctor did warn him that things could get worse. They said he can possibly go back to work on 06Feb2021, but this is not certain at the moment; it could change.
60 2021-02-17 myelitis transverse, weakness, tingling, muscle twitching Few days after receiving the 1st dose, developed tingling paresthesia in both hands. He received his... Read more
Few days after receiving the 1st dose, developed tingling paresthesia in both hands. He received his second vaccination despite the symptoms. Symptoms continued to progress to his feet, and also developed weakness, particularly in his legs. Also had some weakness in arm but more so on the left side. He had difficulty climbing ladder when deer hunting due to weakness in his thighs/legs. He ended up falling in his home on Jan 17, 2021 as well, which caused significant hip pain. Had a neurosurgical evaluation- finding lumbar disease L3-4 requiring fusion. Following surgery, paresthesia and weakness persisted and actually worsened, , developed uncontrolled twitching in both thighs. Further developed loss of function in his L-hand. MRI revealed transverse myelitis. Symptoms have improved with corticosteroid therapy. Patient was hospitalized due to these symptoms for two days, discharged on corticosteroids.
60 2021-02-21 mild one side paralysis, myelitis transverse 3 days after the first injection of the Covid on the left arm the patient developed numbness on the ... Read more
3 days after the first injection of the Covid on the left arm the patient developed numbness on the left side of the body. 21 days later, he received a second injection on the right arm and 3 days later developed right-sided body weakness. I saw the patient for the first time on February 17, 2021
60 2021-02-22 facial paralysis Bells Palsey
60 2021-02-22 muscle twitching Injection site swelling (~2" Diameter), muscular twitching, nerve irritation. No treatment to date.
60 2021-02-23 weakness Upset stomach, headache, severe entire body aches short of breath, diarrhea, chest pressure, chills,... Read more
Upset stomach, headache, severe entire body aches short of breath, diarrhea, chest pressure, chills, fever and body weakness. Talk to Dr. and she recommended to drink plenty of fluids, take Tylenol , and rest.
60 2021-02-25 tremor, speech disorder, slurring, cold sweat Pt received vaccine at 11:20. At 1132 staff member asked RN to assess pt as he began slurring his wo... Read more
Pt received vaccine at 11:20. At 1132 staff member asked RN to assess pt as he began slurring his words and mumbling. VS 97% RA, HR 92, temp 99.8, BP 168/92. Pt is conscious but unable to tell me his name or location. Skin is clammy, patient?s hands are shaky. Wife was notified that we are calling an ambulance for further assessment. Ambulance arrived at 11:48 and pt was taken out shortly before noon.
60 2021-02-26 pain in extremity Soreness at Injection site Lasted one day. Soreness in both shoulders and both upper legs near groin... Read more
Soreness at Injection site Lasted one day. Soreness in both shoulders and both upper legs near groin area till 2:00am heart palpitations started one hour after injections and lasted for 2 1/2 hours.
60 2021-03-02 numbness, tingling Patient was monitored for 30 minutes after first dose of Pfizer vaccine as he reported rash after ta... Read more
Patient was monitored for 30 minutes after first dose of Pfizer vaccine as he reported rash after taking PO Sulfa medication. Per pt he has had no reaction to flu vaccines in the past. Patient left clinic at 0932 but later returned at 0940 c/o feeling loopy. BP at 0940 180/97 HR 63, Radial Pulse 60, Oxygen saturation 100% RA. BP at 0945 172/96 HR 60 left arm. BP at 0958 left arm 167/82 HR 57. Patient monitored by NP and was advised to follow up with his primary care doctor. Pt reports he had derma filers a few weeks ago. Patient c/o feeling redness and numbing in his cheek bones and feeling loopy. Per pt denied history of hypertension only had 2 cups of coffee this morning. Patient?s husband will pick up patient and take him to Hospital as he was advised to do by his primary care doctor who he spoke with while in clinic. Temperature 97.5 F on forehead. Pt declined feeling any itching. Patient was picked up by husband and he will drive patient to Hospital. BP at 1043 184/94 HR 64 Apical Oxygen saturation 97% RA. Patient denied any itching, stated swelling in cheeks and tingling has improved. NP walked patient out of clinic.
60 2021-03-03 numbness Numbness of left hand fingers; stiffness started 15 minutes after vaccine. BP readings: 141/90 (puls... Read more
Numbness of left hand fingers; stiffness started 15 minutes after vaccine. BP readings: 141/90 (pulse 86), and 148/89 (pulse, 84). 100% O2 sat.
60 2021-03-04 burning sensation The described waking up around 9pm after going to be early the day after he received the vaccine. ... Read more
The described waking up around 9pm after going to be early the day after he received the vaccine. He said that his hands burned and itched. He took Benadryl and the symptoms eased after about an hour. He reports he had a similar experience after being exposed to rubella many years ago. At that time the symptoms spread to his whole body.
60 2021-03-05 bell's palsy, facial paralysis I got my second Pfizer COVID vaccine on Friday February 26. On Saturday February 27 I started gettin... Read more
I got my second Pfizer COVID vaccine on Friday February 26. On Saturday February 27 I started getting a droopy lip and a droopy eye lid on the ight side of my face. I went to my doctor on Monday March 1 and after and examination and a CT scan (to eliminate other things), I was diagnosed with Bell?s Palsy. I am now on steroids and antiviral medication. I still have Bell's Palsy at this time,
60 2021-03-05 pain in extremity Arm sore lasted for >24 hours
60 2021-03-11 feeling hot During observation felt hot and sweating No LOC vision blurred Responded to lying down
60 2021-03-11 pain in extremity Very sore arm. fatigue and fever March 9th ,10th and 11th. Dizziness the morning of the 12th. No is... Read more
Very sore arm. fatigue and fever March 9th ,10th and 11th. Dizziness the morning of the 12th. No issues after lunchtime on the 12th.
60 2021-03-13 weakness Diarrhea began about 4:30 pm on 3/1/2021, continued intermittently for 4-5 hours. Significant loss ... Read more
Diarrhea began about 4:30 pm on 3/1/2021, continued intermittently for 4-5 hours. Significant loss of energy and headache began around 8:00 pm on 3/1/2021, and persisted with gradually decreasing intensity until 3/5/2021.
60 2021-03-14 flushing Pt complained of lightheadedness , itching which worsened and he became flushed. Progressed to gener... Read more
Pt complained of lightheadedness , itching which worsened and he became flushed. Progressed to generalized pruritis and redness. BP 117/74, HR70 )2 95% Epi 0.3 IM and Paramedics notified, transported to hosptial
60 2021-03-14 numbness RN responded to pt's report of centralized face numbness (reaching out to eyebrows, mid-cheek, upper... Read more
RN responded to pt's report of centralized face numbness (reaching out to eyebrows, mid-cheek, upper chin). Denied other symptoms. VS: BP 130/80, SpO2 98%, HR 55, RR 18. RN stayed with pt for 10 minutes, pt reported numbness stayed the same, no new symptoms reported. VS rechecked at 15 min: BP 130/90, HR 55, RR 16, SpO2 99%. Arm strength 5/5 bilaterally. RN called EMS due to facial numbness; gave report when EMS arrived. EMS assessed pt, released him to home with instructions to call 911 if any further symptoms. Pt said that he was returning home and he would have a family member there.
60 2021-03-14 pain in extremity fatigue; problems with his gall bladder; 2nd day joint pain; First day sore arm; slight headache/hea... Read more
fatigue; problems with his gall bladder; 2nd day joint pain; First day sore arm; slight headache/headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at the age of 60-year-old at left arm on 23Feb2021 08:15 at single dose for COVID-19 immunization. Medical history included heart failure, sarcoidosis and psoriatic arthritis. The patient wasn't allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced sore arm and slight headache in first day on 23Feb2021 09:00, joint pain in 2nd day on 24Feb2021, headache and fatigue and problems with his gall bladder in 3rd day on 25Feb2021. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient wasn't received 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 hasn't been tested for COVID-19. There wasn't treatment received for the adverse event. The outcome of events was recovered in Feb2021. This report was reported as non-serious report. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect.
60 2021-03-15 weakness FIRST: An ache at the injection site progressing to a throbbing aching. The peak-pain lasted 18 hou... Read more
FIRST: An ache at the injection site progressing to a throbbing aching. The peak-pain lasted 18 hours. Icing the area did nothing to reduce the throbbing. SECOND: Progressive Myasthenia Gravis weakening began about 20 hours after the injection. It was escalating toward being a full-blown crisis. I have an emergency stash of Prednisone, and I alerted my Neurologist that I began taking it. Prednisone effect saved me from a full-blown bulbar deficit, which would have required hospitalization. For MG, I've long only needed to take CellCept to be symptom-free. The Pfizer shot IS to blame for the MG exacerbation
60 2021-03-17 weakness WEAKNESS - GENERALIZED GENERALIZED BODY ACHES SORE THROAT ALLERGIC REACTION
60 2021-03-17 tingling, tremor Severe chills with uncontrollable shaking that lasted 4-5 hours. Fever up to 103.7F for 24 hours. Al... Read more
Severe chills with uncontrollable shaking that lasted 4-5 hours. Fever up to 103.7F for 24 hours. All over skin tingling and pain that lasted 24 hours. Treated with Tylenol and ibuprofen alternating every 3 hours. Applied cold compress to back of neck.
60 2021-03-18 tremor Patient felt nausea and started dry heaving. He was sweating profusely and had tremors. BP 140/60,... Read more
Patient felt nausea and started dry heaving. He was sweating profusely and had tremors. BP 140/60, HR54, O2 sat 98. He stated that he had not had a meal today and it could be his sugar. His glucose was evaluated and was normal. Pt. was taken to NWMC and was accompanied by his wife.
60 2021-03-20 pain in extremity, tenderness Muscle pain in shoulders with more extreme pain in the left shoulder, Left wrist. This muscle pain o... Read more
Muscle pain in shoulders with more extreme pain in the left shoulder, Left wrist. This muscle pain occurred on March 16 and dissipate 2 days later. Then on March 18, 2021 I started to feel muscle pain and swelling in and around my left ankle. On March 20th, 2021 the swelling remain in and around the ankle but the swelling and pain migrated to the first joint of my left big toe. The pain on a scale of 1 to 10 ten is about a 3. The pain elevate to a 10 when touched. Pain is unbearable if I attempt walking on the left leg, as a result I am not able to walk. Swelling has not subsided in 3 days
60 2021-03-20 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Small laceration on right ear from falli... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Small laceration on right ear from falling into shelving area. Cleaned and applied pressure by who was first on scene.
60 2021-03-21 weakness The following day after the second shot, I had a fever for 24 hours, lost my sense of taste, injecti... Read more
The following day after the second shot, I had a fever for 24 hours, lost my sense of taste, injection site pain, weakness/fatigue, chills, swollen lymph nodes/sore throat. 96 hours later (as of this writing) still have diminished sense of taste, swollen lymph nodes/sore throat, quick fatigue.
60 2021-03-21 weakness Flu like for 24 hours. Starting at 8am I was very lethargic. Absolutely no energy. Progressed to te... Read more
Flu like for 24 hours. Starting at 8am I was very lethargic. Absolutely no energy. Progressed to terrible headache, had slight fever and chills. After sleeping from 1pm 3/18 to 6am 3/19 I awoke and felt 100 percent better. Still felt a little tired throughout Sunday 3/20 but not to the point that I couldn't function.
60 2021-03-21 feeling hot Client reported dizziness and warm feeling "all over" 15 minutes after vaccination. Care initiated ... Read more
Client reported dizziness and warm feeling "all over" 15 minutes after vaccination. Care initiated by on site paramedics. B/P 140/80. Monitored x30 minutes. Client reported no further symptoms prior to exiting site.
60 2021-03-21 flushing Shortness of breath Flushing
60 2021-03-22 inability to speak Patient received the vaccine on Tuesday, and on Thursday morning he woke up and couldn't speak and w... Read more
Patient received the vaccine on Tuesday, and on Thursday morning he woke up and couldn't speak and was taken to the hospital and diagnosed with an ischemic stroke
60 2021-03-22 night sweats, pain in extremity Arm pain first day. Lightheaded, feeling like fainting, dizziness, above stomach pain nausea, that h... Read more
Arm pain first day. Lightheaded, feeling like fainting, dizziness, above stomach pain nausea, that happened parallel to erratic high blood pressure, 199/98. Chills, shakes, joints and muscle pain, headache, palpitations, night sweats, severe fatigue. From day 3 to day 17. Went to healthcare facility twice, and two doctor calls.
60 2021-03-22 pain in extremity 1) Cup right ear with hand; Arc described from thumb to little finger, 1/2 -1" depth. Needle sharp ... Read more
1) Cup right ear with hand; Arc described from thumb to little finger, 1/2 -1" depth. Needle sharp jabbing pain, lasts for an instance, yet whole arc "lights up"/pain felt throughout arc. Jabbing every 10-15 secs. Started ~08:00pm 03/03/21 (day after vaccine administered), and continued through the night, till mid-next day 04th. 2) Headache 3/02/21 6pm for the week ( through to 3/9/21) 3) right arm, site vaccine administered, bruised to the touch.
60 2021-03-22 tingling, numbness Sore joints in upper body, neck, shoulders, elbows , wrists & hands. Fingers are tingly and numbing... Read more
Sore joints in upper body, neck, shoulders, elbows , wrists & hands. Fingers are tingly and numbing , this is the most problematic symptom. Headaches come and go infrequently
60 2021-03-23 feeling hot WARM SENSATION FROM FEET TO HEAD Narrative: Patient received 2nd dose of Pfizer COVID vaccine and... Read more
WARM SENSATION FROM FEET TO HEAD Narrative: Patient received 2nd dose of Pfizer COVID vaccine and experienced warm sensation from feet to head twice a few minutes later. No SOB, hives or other symptoms. BP 144/91, P 58, PO2 98% NAD remained stable and improved. Released with instructions to seek medical care if symptoms return.
60 2021-03-23 numbness, burning sensation Burning, numbness sensation on fingers
60 2021-03-24 weakness, bell's palsy, discomfort ER Doctor said I have Bell's Palsy. Left side facial paralysis.; I started feeling funny; I started ... Read more
ER Doctor said I have Bell's Palsy. Left side facial paralysis.; I started feeling funny; I started feeling funny and weak; Eye is watering, feels like there is grit in there; Eye is watering, feels like there is grit; Uncomfortable.; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 12:15 (at the age of 60 years old) as SINGLE DOSE for covid-19 immunisation. Historical Vaccine includes BNT162b2 Dose 1, 10Feb2021 at 14:00 , Lot number=EL9263 in Left arm Medical history included diabetes mellitus. There were no concomitant medications. The patient has no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19 Facility where the most recent COVID-19 vaccine was administered was a Hospital. On 04Mar2021 at 13:15, The patient experienced Bell's palsy. left side facial paralysis (medically significant), started feeling funny and weak, eye is watering, feels like there is grit and uncomfortable. The adverse events resulted in an Emergency Room Visit. Treatment was given for the events. The clinical course is as follows the day after I went to the (Withheld). Patient started feeling funny and weak. Since he was close to a local Hospital Emergency room. ER Doctor said 'I have Bell's Palsy. Left side facial paralysis'. He prescribed prednisone. Have to wear eye patch on left eye. Eye wont close. Can't eat or drink on left side. I was told by my primary care doctor that this could last up to 6 months. And that 85 percent of cases clear up. Eye is watering, feels like there is grit in there. Uncomfortable. Treatment (Prednisone therapy) was given for the events. The clinical outcome of the events Bell's palsy. left side facial paralysis, started feeling funny and weak, eye is watering, feels like there is grit and uncomfortable was not recovered.
60 2021-03-24 weakness Rapid heartbeat (90-115bpm) for 2-3 days while laying in bed. Low pulse ox (88) Fever (101-102F) and... Read more
Rapid heartbeat (90-115bpm) for 2-3 days while laying in bed. Low pulse ox (88) Fever (101-102F) and chills Related difficulty urinating and frequent urination due to prostate inflammation Loss of memory (Brain Fog?) in which I had no memory of events occurring from 3/7-3/9 and little memory on 3/10. Memory was close to normal on 3/12. Two Covid tests with negative results (taken on 3/8 and 3/11) Some lung congestion which could be due to bloody sinus mucus and post nasal drip I did retain my sense of smell and taste but had no appetite and did not eat or ate very minimally from 3/7pm until 3/11pm Very fatigued and weak with knee, hip and general joint pain. Increasing levels of fatigue started on 3/2 with little energy from 3/7-3/11. Fatigue is mostly gone as of 3/23.
60 2021-03-25 feeling hot series of 4 periods where I became quite hot inside and broke out in a heavy dripping sweat over a p... Read more
series of 4 periods where I became quite hot inside and broke out in a heavy dripping sweat over a period of 6 hours or so. It would happen each time, lasting only 15 minutes or so.
60 2021-03-25 pain in extremity rashes, fever, chills, pain in joints and legs, extreme tiredness
60 2021-03-25 tingling, numbness Left upper extremity felt numbness and tingling to Right Chest. Pt experienced some diaphoresis to ... Read more
Left upper extremity felt numbness and tingling to Right Chest. Pt experienced some diaphoresis to face, denies dyspnea. Pt has hx of a vaccine reaction three years s/p 3 years.
60 2021-03-26 numbness Distal digits (finger tip digits) of fingers on both hands have reduced tactile sensory capability. ... Read more
Distal digits (finger tip digits) of fingers on both hands have reduced tactile sensory capability. My finger tips feel numb. Thumb is included in this numbness . First inoculation was 25 Feb. No lingering symptoms. Second inoculation was 19 March. Finger numbness seemed to appear about two days after second shot around 21 March. Numbness still persists even after a week. I felt this numbness was a strange development after the second shot and worth reporting.
60 2021-03-27 weakness Whole body weakness, pain
60 2021-03-27 tremor At around 2:20 in the morning I started getting really bad chills and shakes, I got 103 temperature ... Read more
At around 2:20 in the morning I started getting really bad chills and shakes, I got 103 temperature and within 30 minutes diarrhea and stomach cramps and bodyaches
60 2021-03-28 facial paralysis Right eye lid drooping, could not raise right eye brow, could not blink right eye, could not smile o... Read more
Right eye lid drooping, could not raise right eye brow, could not blink right eye, could not smile on right side of face, could not eat on right side of mouth, pain behind right ear.
60 2021-03-28 numbness numbing of right hand side of face/mouth and right arm. symptoms subsided after about 10-15 minutes... Read more
numbing of right hand side of face/mouth and right arm. symptoms subsided after about 10-15 minutes but continued to present every few days. I advised when i presented for my 2nd shot and they told me they had other reports of that and that is was fine/safe for me to take the 2nd shot, but to wait in a holding area for 30 minutes after the shot.
60 2021-03-29 weakness Started being cold around 11:00 on 3/29 - less energy throughout day - goose bumps from being cold a... Read more
Started being cold around 11:00 on 3/29 - less energy throughout day - goose bumps from being cold around 9:45PM. Woke up throughout night with lower back/neck pain and headache. Now (7:18AM) experiencing headache, nausea, neck ache, chills and lower back pain. Feels like a hangover.
60 2021-03-29 feeling hot About 45 minutes after first Pfizer shot I experienced a feeling like a warm starburst in the center... Read more
About 45 minutes after first Pfizer shot I experienced a feeling like a warm starburst in the center of my head... and got very dizzy. It started in the center of my head and spread in all directions to fill my head. I was driving and had to pull over. It passed after about five minutes. After that I felt a bit weak and slept that afternoon and most of next day.
60 2021-03-29 muscle spasms Muscle aches, joint aches, chills, fever, head ache, muscle spasms
60 2021-03-30 facial paralysis, slurring, face paralysis loss of taste; possible allergic reaction to the drug; Can't pronounce words right; can't close righ... Read more
loss of taste; possible allergic reaction to the drug; Can't pronounce words right; can't close right eye; eyes started to tear a lot; can't smile; right side of his face started drooping like that of a stroke; right side of his face started drooping like that of a stroke; headache at the back of his head; mouth started to feel numb; mouth started to feel numb; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 61 year old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) at the age of 60 years old, via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EL6205) as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, mouth started to feel numb and allergies to tree pollen; and family history of diabetic and heart disease (father); all from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium (TEMISARTAN), gabapentin, escitalopram oxalate (LEXAPRO), furosemide, potassium, valproate semisodium (DIVALPROEX) and tizanidine; all taken for an unspecified indication from an unspecified start date and ongoing. The patient received the first dose of BNT162B2. The next day, he said his mouth started to feel numb, and he had a loss of taste. Then on Saturday, his eyes started to tear a lot, and the right side of his face started drooping like that of a stroke. He also said he had headache on the back of his head, and his eyes do not. The patient wanted to know if he should go to the emergency room or if this is a normal reaction to the vaccine. The patient did have a sensation starting on Thursday of numbness in his mouth. The patient describes it as a feeling like when he was younger and would use chloraseptic spray, it feels like same numbness. He states that on Saturday his eyes started tearing up, and he does have allergies to tree pollen. The right side of his face feels and looks like he had a stroke, it is droopy on right side. The patient can't pronounce words right, can't smile, and can't close his right eye. The patient was checked with heart rate and EKG with his little machine and his temperature, and they all seem fine. The patient was also getting headaches at the back of his head. The patient took Advil for headaches, but it is not improving. The patient ran out of the Advil and doesn't have the bottle anymore. The patient took allergy pills, a knock off Benadryl, because he thought his eye tearing was possibly from allergies to tree pollen allergy or possible allergic reaction to the drug. The patient underwent lab tests and procedures which included body temperature: fine, CAT: not reported, EKG: fine, complete blood work: not reported and heart rate: fine; all on 15Mar2021. The outcome of loss of taste was unknown. The outcome of the rest of the events was not recovered. Information on the lot/batch number has been requested.
60 2021-03-30 tingling Site: Pain at Injection Site-Medium, Systemic: daughter described it as \"ants crawling under skin\"... Read more
Site: Pain at Injection Site-Medium, Systemic: daughter described it as \"ants crawling under skin\"-Severe
60 2021-03-31 pain in extremity Arm pain at injection site started 24hours later lasted 72 hours, Drowsiness started with in hours o... Read more
Arm pain at injection site started 24hours later lasted 72 hours, Drowsiness started with in hours of injection lasted 48 hours,Sweating,Vomiting ,Dizziness,chills and Rapid heart beat started 48 hours later,sweating and vomiting lasted and hour.Rapid heart beat lasted about 15 min. Took anti nausea medicine for the vomiting and Tylenol & Motrin for arm pain.
60 2021-03-31 pain in extremity On Jan 22, Developed sudden onset of left hand swelling , progressed to left hand throbbing pain wit... Read more
On Jan 22, Developed sudden onset of left hand swelling , progressed to left hand throbbing pain with decreased ability to preform simple task. treated rleased / march 23- developed same symptoms / march 28th recurrent symtoms. On 1/22/21 treated at ER w/ oral predisone , with improvement. / 0n jan 25th eval at Health Center . for Eval/ On march 23 seen at ER for recurrent symtoms . Had Xray, treated with oral prednisone // On 3/28 recurrent symptoms.
60 2021-03-31 tingling, tremor, migraine Day 1-Chills/Shaking, Body Aches, Dizziness, Itchy Throat, wheezing breathing, difficult walking, ex... Read more
Day 1-Chills/Shaking, Body Aches, Dizziness, Itchy Throat, wheezing breathing, difficult walking, extreme fatigue, Abdominal cramping. Day 2-Injection site pain, Nausea, fatigue.Day 3-Nausea,fatigue.Day4-Extreme lower and mid back pain, indigestion, gas, bloating, constipation.Day5-Fatigue lower back pain.Day6-Fatigue,lower back pain.Day7-Fatigue,lower back pain.Day8-Fatigue, Rash appears on torso and back, red bumps and itchy, Fever onset.Day9 Fatigue, Fever, rash itchy red bumps.Day10-Joint pain onset, Knees swollen large, reduced range of motion, hamstrings cramped up. Feet swollen and tingling. Rash over entire torso.Day11-rash abated, knees and legs swollen with limited range.Day12-Cramps hamstrings and knees swollen. Day13-Knees and leg cramps, fatigueDay14-Knees and legs cramped, fatigue.Day15-nausea,fatigue, hives on side and feet.Day16 Migraine onset, severe nausea, high fever, no sleep.Day17- extreme migraine, fatigue, nausea, hives.Day18-migraine,nausea,hivesDay19-Nausea,hives,fatigueDay20patchy hives, fatigue. Fatigue through to April 1, Skipped second dose.
60 2021-04-01 muscle twitching, myelitis transverse, pain in extremity Transverse Myelitis; spastic twitching in thighs; severe back and leg pain; severe back and leg pain... Read more
Transverse Myelitis; spastic twitching in thighs; severe back and leg pain; severe back and leg pain; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiration date not provided) via an unspecified route of administration, administered in left arm on 07Jan2021 15:00 as a single dose for COVID-19 immunisation. Medical history includes Hypertension, Gastrooesophageal reflux disease (GERD), prostate cancer and broncholith left lung. The patient has no known allergy. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine, losartan, pantoprazole, hctz, and acetylsalicylic acid (ASPIRIN). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on 17Dec2020 and experienced mild numbness and tingling in arms and legs following first dose of vaccine, followed by progressive weakness in legs. On 19Jan2021, the patient developed severe back and leg pain resulting in spinal fusion surgery on 25Jan2021. Postoperatively, the patient developed spastic twitching in thighs on 31Jan2021. On 07Feb2021, he woke up with weakness and clumsiness in left hand. At post-op check for spinal surgery on 10Feb2021, the neurosurgeon recommended another MRI and mentioned possibility of Transverse Myelitis. Following this MRI on 15Feb2021, he was again admitted to hospital for more extensive work up and was admitted for 6 days. Diagnosis made of Transverse Myelitis and was started on high dose steroid treatment and was discharged to home on 17Feb2021. Since then have had profound leg weakness, right side greater than left, which severely impairs mobility, especially stairs. He completed 5 day course of 1000 mg methylprednisolone per day as an outpatient on 20Feb2021. He is in PT and is unable to predict date of return to work. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment for the events included high dose steroid therapy, PT and exercise. The patient underwent COVID test post vaccination via nasal swab on 24Jan2021 and was negative. The outcome of the events was recovering.; Sender's Comments: Based on available information the reported events are unlikely related to BNT162B2. These are intercurrent medical conditions. Case will be reassessed if additional information is received. 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.
60 2021-04-02 feeling hot, feeling cold Very bad stomach cramping, nausea and vomiting. Started when I woke up this morning around 7am. A... Read more
Very bad stomach cramping, nausea and vomiting. Started when I woke up this morning around 7am. Also, I go from being hot to being cold.
60 2021-04-02 tingling, numbness mild numbness and tingling arms and legs; mild numbness and tingling arms and legs; weakness in legs... Read more
mild numbness and tingling arms and legs; mild numbness and tingling arms and legs; weakness in legs; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK5730), dose 1 via an unspecified route of administration, administered in Arm Left on 17Dec2020 15:00 (at the age of 60years) as single dose for Covid-19 immunization. Medical history included hypertension, GERD (gastrooesophageal reflux disease), prostate cancer, broncholith left lung; all from an unspecified date. Concomitant medications included amlodipine, losartan, pantoprazole, hydrochlorothiazide (HCTZ), and acetylsalicylic acid (ASPIRIN (E.C.)); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Dec2020, the patient initially experienced mild numbness and tingling in arms and legs following first dose of vaccine, followed by progressive weakness in legs. The patient was hospitalized for 6 days from an unspecified date to an unspecified date. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, and Disability or permanent damage. The patient was tested for Covid-19 post vaccination (Nasal Swab) 24Jan2021 with negative result. The outcome of events was recovering.
60 2021-04-02 unresponsive to stimuli, inability to speak Pt got vaccine at pharmacy off site clinic - this is notes from clinic staff "summary - pt was unabl... Read more
Pt got vaccine at pharmacy off site clinic - this is notes from clinic staff "summary - pt was unable to speak and became somewhat unresponsive 15 minutes after 2nd Pfizer covid dose. family informed clinic staff after he had returned to the car. history of hypertension/diabetes/kidney transplant. Insulin was administered this morning. 911 was immediately called, taken to er. current condition unknown. blood glucose was 500+ when paramedics checked"
60 2021-04-03 feeling hot Had shot at 2:30 Pm, Sitting in my truck and about 2:35 i started getting a warm feeling in my legs... Read more
Had shot at 2:30 Pm, Sitting in my truck and about 2:35 i started getting a warm feeling in my legs and feet (waist down) (Felt like same feeling when getting a CT scan when getting the dye put in veins,) Lasted about 25 minutes . then stated to feel it wear off. tired next day but dont know if from vaccine. (did not go to doctor)
60 2021-04-03 pain in extremity First injection: Sore arm that received initial injection for about one day. No treatments. Second... Read more
First injection: Sore arm that received initial injection for about one day. No treatments. Second injection received on other arm (right): Sore arm. The next day arm was sore, perhaps sooner. Also, the next day I was lethargic/sleepy, had a slight chill and was sore in at least some joints, including ankles. No treatments other than staying in bed. The second day I was close to back to full energy. Now a month later I'm occasionally naps these days, which I wonder whether are prompted by the vaccination.
60 2021-04-05 concussion after receiving my second pfizer vaccine, i blacked out, broke my nose, and had a concussion. I had ... Read more
after receiving my second pfizer vaccine, i blacked out, broke my nose, and had a concussion. I had maxillofacial surgery the next day. 5 weeks later, i developed DVT, and now have pulmonary embolisms.
60 2021-04-05 mild one side paralysis On 4/2/2021 my dad feel headache and nausea. no power right side arm and leg
60 2021-04-05 pain in extremity 4/3/2021, Initial Stinging pain at time of injection 4/3/2021 - 4/5/2021, Pain on the left arm (in... Read more
4/3/2021, Initial Stinging pain at time of injection 4/3/2021 - 4/5/2021, Pain on the left arm (injection site) extending into my shoulder and down to my wrist. 4/5//2021 - Current, Pain Reduced, but will be setting up an provider appointment. 4/3/2021 - 4/5/2021, Nauseas 4/3/2021 - 4/5/2021, Severe Headache, used Tylenol medication to reduce the pain. 4/5//2021 - Current, Light headache, Using Tylenol for relief
60 2021-04-06 inability to speak, numbness His left arm is numb waking up this morning. He is dizzy and having trouble comprehending things. He... Read more
His left arm is numb waking up this morning. He is dizzy and having trouble comprehending things. He has never acted this way before. Its like he in slow motion.
60 2021-04-06 bell's palsy earache, headache and Bell's Palsy on left side of fac
60 2021-04-06 numbness Starting Monday at work I began to feel very tired, my muscles started aching across my back at shou... Read more
Starting Monday at work I began to feel very tired, my muscles started aching across my back at shoulder level, and my hands went numb. I went home and took Tuesday off to rest. Wednesday this has continued and I may leave work again. I have also had some very sharp pains in my joints.
60 2021-04-06 pain in extremity, night sweats, tremor lightheaded; stomach pain; feeling like fainting; that happened parallel to erratic high blood press... Read more
lightheaded; stomach pain; feeling like fainting; that happened parallel to erratic high blood pressure 199/98.; nausea; Arm pain first day.; fatigue; palpitations; shakes; joints and muscle pain; joints and muscle pain; headache; Chills; night sweats; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 10:30 (Batch/Lot Number: EN6199) as SINGLE DOSE (at the age of 60 years) for covid-19 immunisation . Medical history included immune thrombocytopenia from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing , covid-19 from Mar2020 to Sep2020, (COVID 19 Long-Hauler from Mar-Sep2020). Concomitant medications included amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL); simvastatin (SIMVASTATIN). The patient previously took aspirin [acetylsalicylic acid] and experienced anaphylactic reaction, zantac and experienced rash and experienced peripheral swelling. The patient experienced feeling like fainting (medically significant) on 13Mar2021 14:30 with outcome of recovering , that happened parallel to erratic high blood pressure 199/98 on 13Mar2021 14:30 with outcome of recovering , palpitations on Mar2021 with outcome of recovering , lightheaded on 13Mar2021 14:30 with outcome of recovering , stomach pain on 13Mar2021 14:30 with outcome of recovering , shakes on Mar2021 with outcome of recovering , joints and muscle pain, headache on Mar2021 with outcome of recovering , chills on Mar2021 with outcome of recovering , night sweats on Mar2021 with outcome of recovering , nausea on 13Mar2021 14:30 with outcome of recovering , arm pain first day on 09Mar2021 with outcome of recovering , fatigue on Mar2021 with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: 120's-30's/70's, blood pressure measurement: 199/98 on 13Mar2021, platelet count: 99, sars-cov-2 test: Several negative tests on unspecified date. The patient went to Urgent Care twice. The patient took no other vaccine in four weeks and the patient was not COVID tested post vaccination.
60 2021-04-07 tingling, cold extremities Pain at injection site. Progress to under the arm. Also lymph nodes under arm are noticeable to the ... Read more
Pain at injection site. Progress to under the arm. Also lymph nodes under arm are noticeable to the touch and water build up on the right under arm chest wall. Some coldness in hand and occasional tingling. Shoulder area feels heavy.
60 2021-04-08 weakness weakness, nausea, vomiting, shortness of breath, diarrhea, muscle aches concern about antibody-depe... Read more
weakness, nausea, vomiting, shortness of breath, diarrhea, muscle aches concern about antibody-dependent enhancement
60 2021-04-08 discomfort Swollen glands under the arm pit. Little discomfort
60 2021-04-09 breast pain Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upp... Read more
Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Small bumps directly around lymph nodes with intense itching which feels like it's on the inside sometimes; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 18Mar2021 12:00 as single dose for COVID-19 immunization. Medical history included SAPHO syndrome, vasculitis, gout, arthritis, carpal tunnel syndrome, hot peppers and garlic sensitivity, and seasonal rhinitis allergy, all from an unknown date. The patient has no COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included ibuprofen; pregabalin (LYRICA); methotrexate; omeprazole; and paracetamol (TYLENOL), all taken for an unspecified indication. The patient previously took Biaxin and Bactrim and experienced allergies. On 20Mar2021, 04:00, the patient experienced pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, and upper back. Onset was intense aching pain two days post injection. Small bumps directly around lymph nodes with intense itching which felt like it's on the inside sometimes was reported. It was a Monday night of 22Apr2021 at 9:55 PM and symptoms were static, not worsening not improving. No treatment was received for the events. The outcome of the events was not recovered.
60 2021-04-11 numbness, breast pain Burning upon injection. Numbness at injection site and entire left arm. 100.6 fever. Switch between ... Read more
Burning upon injection. Numbness at injection site and entire left arm. 100.6 fever. Switch between chills and feverish and sweating. Intense pain under left breast radiating tru to left shoulder blade. 22 hours after injection, vomiting began and lasted the next 14 hours. Appetite is gone. 4th day post shot and all I've consumed is a banana and a yougurt. I has Covid 09/20 and the injection reaction was worse than Covid.
60 2021-04-12 tingling, numbness Left arm tingling and numbness from hand to shoulder. Aching. No injection site redness or swellin... Read more
Left arm tingling and numbness from hand to shoulder. Aching. No injection site redness or swelling. No palsy or other symptoms. Symptoms began on Day 10 post injection and continue. Had brief, faint chest pains last night, 4/12, while walking to car after restaurant prepared sea bass meal. This morning my arm is tingling and aches like it has been slept on or is not receiving proper blood flow. Right arm is fine. BP normal. Breathing normal. No other issues.
60 2021-04-12 seizure Patient was with Medical Examiner. She was reviewing his allergies (PCN, bee stings) and discussed ... Read more
Patient was with Medical Examiner. She was reviewing his allergies (PCN, bee stings) and discussed with patient need to wait 30 minutes after vaccine for observation. She then gave him pfizer vaccine. Within 1 minute of giving vaccine, patient began to have seizure. He was assisted to ground by MD and RNs at vaccination site. He was assessed and assisted to remain safe throughout seizure, 911 called and arrived on scene. Meanwhile, caregiver with patient stated seizures are "normal" for him and he has 4-5 a day. She reported that in line he was not feeling well and had precursors to seizure. Patient had reported to MD that he felt fine today and did not report seizure history to her previous to giving vaccine. It was also later reported that he had a seizure the night before as well. IVF were started by RN's. When emergency services arrived, patient was recovering and refusing to go to ER - against medical advice. He was assisted back into wheelchair by emergency services personnel. Patient was alert, and oriented and able to make decision not to go to emergency room. Patient left facility with caregiver in private vehicle. Patient was instructed to contact his primary care physician and let them know what happened and ask if 2nd dose of pfizer is appropriate for him. Patient was also instructed if MD wants him to get 2nd dose to go to a more controlled setting then Mass vaccination site.
60 2021-04-13 weakness, electric shock sensation, cold sweat Body muscle aches. Cold sweats. Weak upset stomach. Raised body temperature 99.7 and dissyness and ... Read more
Body muscle aches. Cold sweats. Weak upset stomach. Raised body temperature 99.7 and dissyness and brain zaps.
60 2021-04-13 pain in extremity Blood clot in left leg; first noticed on March 17; swelling and pain bad by March 19, called advice ... Read more
Blood clot in left leg; first noticed on March 17; swelling and pain bad by March 19, called advice nurse who told me it sounded like a blood clot and told me to go to emergency room.
60 2021-04-13 tremor This was the second shot. I didn't expect to get sick since I had been sick after the first one. S... Read more
This was the second shot. I didn't expect to get sick since I had been sick after the first one. Symptoms were for the first night uncontrollable shaking, vomiting & light fever (100). This is the second day and I feel tired although I slept about 20:00 hours yesterday and 12 today. Expect to recover tomorrow!
60 2021-04-14 pain in extremity Acute onset left foot pain (5th metatarsal protuberance), lasted six days, resolved with ibuprofen, ... Read more
Acute onset left foot pain (5th metatarsal protuberance), lasted six days, resolved with ibuprofen, colchicine, Keflex. Prompted urgent care clinic visit on 4/13/2021 where x-rays showed no abnormalities. Diagnosed as probable gout flare (my first first diagnosis of gout, but second episode of this type of pain).
60 2021-04-14 tremor Pt. with hx of hypoxia, oxygen at night, CAD, seizure disorder. Started feeling light headed, SOB of... Read more
Pt. with hx of hypoxia, oxygen at night, CAD, seizure disorder. Started feeling light headed, SOB of 4-5 min. after injection. Pt.brought to procedure room. Initial vs at 4:20, 118/78, p 105, r 18. O2 placed, sat up to 98% on 2l. 911 called. Started feeling better on o2. SOB improved. Due to hx of CAD, epi not given. PE: heart rate reg 95, lungs cta, upper airway without stridor, swallowing well. Squad arrived. Repeat bp 120/80, sat 98%, r 16. pt. exhibited some shakes and felt he might seize. Shakes stopped in 10 sec. Transported in stable condition to ED.
60 2021-04-15 slurring, mild one side paralysis, facial paralysis Presented to ER on 4/8 with slurred speech, left sided weakness, and facial droop. Was diagnosed wit... Read more
Presented to ER on 4/8 with slurred speech, left sided weakness, and facial droop. Was diagnosed with right posterior cerebral artery occlusion and started on Alteplase for tPA and transferred to Medical Center on 4/9.
60 2021-04-15 mild one side paralysis, inability to speak 60-year-old male with essentially no past medical history who developed acute left-sided weakness an... Read more
60-year-old male with essentially no past medical history who developed acute left-sided weakness and aphasia. EMS was immediately called and he was taken to healthcare facility. He underwent an immediate work-up with an NIH of 12 with left hemiparesis. CT scan of the head did not show any evidence of acute bleed CTA was consistent with a right M1 occlusion. Patient was given TNKase at 0 755 and taken immediately for thrombectomy. Therapies successful. Patient has not had Covid during this pandemic but did receive the first dose of the pfizer immunization yesterday in his left arm.
60 2021-04-17 numbness numbness and weakness in my legs; numbness and weakness in my legs; difficulty urinating; This is a ... Read more
numbness and weakness in my legs; numbness and weakness in my legs; difficulty urinating; This is a spontaneous report from a contactable consumer (reporting for himself). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Leg Left on 11Mar2021 at 05:30 (Batch/Lot Number: EN6208) as single dose for COVID-19 immunization. Medical history included transverse myelitis. The patient's concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) and terbinafine, both for unspecified indication and experienced allergies. On 11Mar2021 at 10:30, the patient experienced numbness and weakness in his legs and some difficulty urinating. The patient was hospitalized. The patient did not received treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Mar2021. The outcome of the events was recovering. Information about Lot/Batch number has been requested.
60 2021-04-17 pain in extremity Arm pain; Tired; Abdominal swelling; This is a spontaneous report from a contactable consumer (patie... Read more
Arm pain; Tired; Abdominal swelling; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8730), via an unspecified route of administration, in left arm on 27Mar2021 at 12:00 (at the age of 60-year-old) at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient hasn't been tested for COVID-19. The patient experienced arm pain, tired and abdominal swelling on 29Mar2021. The events were reported as non serious. The patient didn't receive any treatment for the events. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
60 2021-04-18 feeling hot Several minutes after injection patient began feeling hot and fainted - Patient never lost conscious... Read more
Several minutes after injection patient began feeling hot and fainted - Patient never lost consciousness, breathing remained regular, but complained of neck pain
60 2021-04-18 flushing Face and arms visibly flushed. HX hypertension. No difficulty breathing or tightness in throat. Vit... Read more
Face and arms visibly flushed. HX hypertension. No difficulty breathing or tightness in throat. Vital Signs: BP 150/80 HR 72 O2Sat 97% Skin Signs: Warm and dry, Other - Very red and flushed warm to touch Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally No increased res. effort Initial treatment: Continue observation. Patient observed to be flushed prior to vaccination. HX of rosacea. Patient states HX of sun exposure prior to clinic. 11:13 AM Vital Signs: BP 138/74 HR 76 Resp. 16-18 O2Sat 95% Possible irregular HR noted while getting BP Skin Signs: Other - Flushed A/Ox4 Circulation: Cap refill >2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: Observation. No increased res. effort. Neg S/S anaphylaxis. 11:19 AM Vital Signs: BP 122/80 HR 78 Resp 14-16 O2Sat: 95% Skin Signs: Warm and dry, Other - Flushed A/Ox4 Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Notes: Vitals at 11:32 AM BP 130/72 HR 81 O2Sat 94% Lung sounds clear bilaterally Resp 16 Patient states no dyspnea upon sitting. Cap refill <1sec No nausea Patient instructed to update son. Released home by self.
60 2021-04-19 bell's palsy, facial paralysis Bell's palsy (left sided facial droop). Pt first noted symptoms 2 days after vaccine.
60 2021-04-19 bell's palsy Left Sided Bells Palsy - began approximately 36 hours after first vaccination.
60 2021-04-19 mild one side paralysis Pt went to ED for R-sided weakness and dizziness. then subsequently had CVA.
60 2021-04-19 numbness Left perioral and lower cheek numbness or anesthesia. Began shortly after leaving facility. Lasted 4... Read more
Left perioral and lower cheek numbness or anesthesia. Began shortly after leaving facility. Lasted 48 hours. No loss of motor function. No other symptoms.
60 2021-04-20 numbness Slight numbness in left cheek. Sensation can be described as like one had a novocain injection 3 hou... Read more
Slight numbness in left cheek. Sensation can be described as like one had a novocain injection 3 hours earlier. It has persisted for 2 days. All functions (speech, eating, drinking, etc) are normal. No treatment.
60 2021-04-20 pain in extremity Rash around injection site. Hard warm lump where needle was inserted and vaccine injected. Approx ... Read more
Rash around injection site. Hard warm lump where needle was inserted and vaccine injected. Approx 1 in by 4 in. Shoulder is sore and feels hot. Painful to touch.
60 2021-04-21 numbness Developed left facial numbness-minor left lower periorbital + cheek with gradual increase and decrea... Read more
Developed left facial numbness-minor left lower periorbital + cheek with gradual increase and decrease after he left the vaccine clinic. Reaction resolved in 48 hours.
60 2021-04-22 bell's palsy Bell's Palsy of Left lower face/jaw started upon waking 4/22/21, pt's 2nd dose was 4/20/21
60 2021-04-22 pain in extremity Pain on my left leg.
60 2021-04-22 tingling Had 2nd covid vaccine shot April 8th at 1:15PM. Friday evening started feeing tingling in left arm a... Read more
Had 2nd covid vaccine shot April 8th at 1:15PM. Friday evening started feeing tingling in left arm and skin on stomach. Saturday noticed rash on stomach. Sunday rash had grown. Wend Sunday April 11th to urgent care and was diagnosed with shingles. Was given a 7 day prescription for Valtrex. Two weeks later finally beginning to to see a reduction in the rash and pain.
60 2021-04-23 inability to speak To bed about 10:30p. Awoke 11:30p & could not talk, shivering uncontrollably, couldn't move my legs... Read more
To bed about 10:30p. Awoke 11:30p & could not talk, shivering uncontrollably, couldn't move my legs, & no feeling in feet & legs. Very difficult to breathe. Was alert. Wife up to BR, looked over, I was trying to say help. Brought me water. she assisted me up , then back to bed, still shivering uncontrollably. 30 mins to 1 hr later, my son saw me in the hall and said, "Dad, you look like ****". I could not make a sentence. Per my son all I said was, "Gatorade". I drank it then fell asleep. next morning 101 temp, severe fatigue, severe aches and pains, could not make complete sentences I was told. I did have COVID 19 for 4 weeks Oct-Nov 2020.
60 2021-04-23 night sweats Bony pain; night sweats; This is a spontaneous report from a contactable consumer (patient). A 60-ye... Read more
Bony pain; night sweats; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 1 via an unspecified route of administration, administered in Leg Left on 20Feb2021 12:45 (Lot Number: EN6201) at the age of 60 years old as single dose for covid-19 immunisation. Medical history included Covid prior vaccination, Hypertension, Diabetic, No Known allergies. The patient's concomitant mediations received in two weeks included medications for Hypertension and Diabetic Medication. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced Bony pain and night sweats on 21Feb2021 at 11:45 AM. No treatment received for the events. No covid tested post vaccination. The outcome of the events was recovering. The report was serious per the reporter.
60 2021-04-23 tingling Paresthesia of the right leg/thigh after getting the vaccine; This is a spontaneous report received ... Read more
Paresthesia of the right leg/thigh after getting the vaccine; This is a spontaneous report received via Pfizer sponsored program from a contactable physician (patient). A 60-year-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 9231) via intramuscular route in left arm on 29Dec2020 01:00 AM (at the age of 60-year-old) at single dose for COVID-19 immunisation. There was no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID- 19 (nasal swab and Abbott Antigen) on 14Feb2021 and resulted negative. On 09Jan2021 13:00, the patient experienced paresthesia of the right leg/thigh after getting the vaccine. The patient did not receive any treatment for the event. The outcome of event was not recovered/not resolved.
60 2021-04-24 weakness Chills, Dizzinesss and Weakness 5-10 minutes after invection. Cough and sore throat 12 hours after ... Read more
Chills, Dizzinesss and Weakness 5-10 minutes after invection. Cough and sore throat 12 hours after injection.
60 2021-04-24 numbness, paralysis new numbness and pins & needles in left leg; It causes paralysis in muscles; CPK increased; This is ... Read more
new numbness and pins & needles in left leg; It causes paralysis in muscles; CPK increased; This is a spontaneous report from a contactable consumer (patient). This 60-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 at single dose in right arm for COVID-19 immunisation at the age of 60-year-old. Medical history and concomitant medications were unknown. Historical vaccine included fatigue with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 for Covid-19 immunisation at the age of 60-year-old (1st dose, at 09:30, leftarm). The patient got up one day and legs where paralyzed on 08Apr2021. The patient kept trying to stand and walk thinking it was just legs fallen asleep, but the patient was falling every time she would try to walk it off. On 08Apr2021 at 07:30, new numbness and pins and needles in left leg. The patient was hospitalized due to the events and they were considered as disabiliting and life-threatening. The patient then had a bad moment when on his way to leave for pcp appt (as reported), a steel cabinet fell on him. The patient was taken by ems to trauma unit in Hospital. Creatine phosphokinase (CPK) levels were over 2,000 on unknown date. The outcome of Creatine phosphokinase increased was unknown, the patient was recovering from other events. Information on the Lot/Batch number has been requested.
60 2021-04-24 migraine migraine headaches/cluster migraines; This is spontaneous report received from contactable consumer ... Read more
migraine headaches/cluster migraines; This is spontaneous report received from contactable consumer (patient) reported for himself. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Mar2021 at age of 60 years old at single dose for COVID-19 immunisation. Medical History: patient typically has had migraines, cluster headaches in the past and he had figured out what it was that was causing it. Patient states it was certain supplements that he discontinued and hasn't had a migraine in three years. Patient states he had diagnosed with migraines maybe in 1992, 1993, 1994, the early 90s. Food allergies. Allergic to caffeine. Concomitant medications were not reported. Patient previously took sumatriptan succinate (IMITREX) for migraine headaches. Patient states typically he can take ibuprofen (ADVIL), pseudoephedrine hydrochloride (SUDAFED), and loratadine;pseudoephedrine sulfate (CLARITIN-D), but they were not really helping his headaches. Patient had a history of migraines. He received his vaccine on 27Mar2021. Since the next day, he has had migraine headaches non-stop (28Mar2021 and ongoing). It had been 3 years since he last had migraines, however they started since the vaccine. He has had 2 emergency room visits, he missed 2 days of work last week due to the headaches. He feels the cluster sparks as a dull migraine at this moment. He had a side effect after the first dose of the vaccine. Asked if he should get the second dose. Response: 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. Patient would like to know whether there was anything he can take for his migraines. Patient replied that he was not helped by the information provided to him. Migraine headaches and they have been non-stop was reported as worsened. Patient stated he had the first vaccine shot and he was reading information and it mentioned something about allergies. Patient states he has food allergies and he got migraine headaches. Patient states he took the first vaccine two Saturdays ago and as of that Sunday evening, Monday, he started having migraine headaches and they have been non-stop. Patient states he is wondering if he should take the next shot and if there was something he can do or take for the headaches. Patient states it was cluster migraines, he has not had migraines in like three years. Prescribing Healthcare Professional: Patient states he is getting ready to change. Patient states he was supposed to have an appointment today and she cancelled on him. Patient states it seems like every time he makes an appointment in the afternoon, she cancels on him. Patient states he had the vaccine on Saturday, 27Mar2021 and the migraines started Sunday evening. Migraine headaches: Patient states on Monday evening, early Tuesday, he went to the emergency room because it was just excruciating, unbearable. Patient states what has worked for him in the past was sumatriptan succinate (IMITREX). Patient states they gave him a couple of things, but that's only temporary. He stayed for a few hours and then send him home. Patient states he missed two days of work last week and missed yesterday due to the headaches. Patient states they start around midnight, 1230 every night and it goes for several hours. Patient states typically he can take ibuprofen (ADVIL), pseudoephedrine hydrochloride (SUDAFED), and loratadine;pseudoephedrine sulfate (CLARITIN-D), but they were not really helping his headaches. Patient states they are helping a little bit as a temporary thing, but he finds himself having to take more because the pain gets worse. Patient states he was taking two Advil and it was helping a little bit but now he is taking four, which is 800mg. Patient states he does not have the bottles with him; therefore is unsure of NDC, LOT, or Expiry dates for Advil, Sudafed, or Claritin-D. Migraine headaches: Patient states now it was a dull headache, but he had to come to work today, but he has a headache. Patient states he can feel the shooting clusters going through on the right side. Patient states he thinks it was BioNtech, but doesn't remember the dosage. Patient unsure of NDC, LOT, or Expiry date. Pfizer Covid Vaccine: Indication: Caller states for safety reasons and his mother had received it and she lives with him. Caller states his family was getting it and just for precaution. Test Results: Caller states he went to the emergency room last Tuesday morning, they did draw blood and they did a CAT scan and blood work but they said they didn't see anything. Caller unsure of blood tests they did. Caller states but like he said, whenever it occurs, it was always on the right side, right above his eye to the rear of his head. Caller verifies he received medicine, Imitrex, then was sent home a few hours later. He was not admitted overnight. Time the Vaccination was Given: appointment was at 0845, so around 0900 or 0915. There is no history of all previous immunizations with the Pfizer vaccine considered as suspect. Caller verified he has only received one dose. Caller states he is due to get his next one on 17APR2021, which is a Saturday. There is no additional vaccines administered on same date of the Pfizer suspect. The adverse events (AE) migraine headaches require a visit to Emergency Room, Caller states they gave him blue tablets and then Imitrex. He has allergic to caffeine so he can not have that, and then they sent him home. And caller states he was supposed to have an appointment today to see his doctor, but she cancelled. Prior Vaccinations within 4 weeks, there was no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Caller verifies that he is wondering if he should take the next shot and if there was something he can do or take for the headaches to hopefully eliminate them. Caller states he was reading the information sheet and it said if he has an allergic reaction, not to take the vaccine. Outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.
60 2021-04-24 muscle spasms he got positive with Covid-19; dizziness; woke up sweating; chills; muscle spasms; can not eat; Coug... Read more
he got positive with Covid-19; dizziness; woke up sweating; chills; muscle spasms; can not eat; Coughing; This is a spontaneous case is received from a contactable consumer. A 60-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced he got positive with covid-19 (sars-cov-2 test positive), dizziness on 06Apr2021, chills on 04Apr2021, muscle spasms on 04Apr2021, coughing (cough) on 01Apr2021, woke up sweating (hyperhidrosis) on 06Apr2021, cannot eat (feeding disorder)on 03Apr2021. The patient underwent lab tests and procedures which included sars-cov-1 test: positive. Therapeutic measures were taken as a result of, woke up sweating (hyperhidrosis). The outcome of the events sars-cov-2 test positive was unknown, chills, cough, feeding disorder were recovering, dizziness, hyperhidrosis were recovered on 06Apr2021, muscle spasms were recovered on 04Apr2021. Follow-up activities have been completed and no further information is expected.
60 2021-04-24 pain in extremity Minor arm pain. Aches started in jaw followed by headache and fever. Significant fatigue. Lasted ... Read more
Minor arm pain. Aches started in jaw followed by headache and fever. Significant fatigue. Lasted about 22 hours.
60 2021-04-25 pain in extremity My left arm is painful above the elbow, arm is very weak, trouble carrying things. Joint pains, sti... Read more
My left arm is painful above the elbow, arm is very weak, trouble carrying things. Joint pains, stiffness, extreme pain in my knees, painful to the touch, sharp pains when I step or turn wrong.
60 2021-04-25 tension headache Caller reports ER visit day after getting vaccine for chest tightness and ?extreme sedation?. Calle... Read more
Caller reports ER visit day after getting vaccine for chest tightness and ?extreme sedation?. Caller was discharged and has had some chills since then. Also reports fogginess and tension headaches. States he was in the ER last night and was treated and released.
60 2021-04-26 burning sensation, muscle spasms Lower back and left leg spasms (LLE spasms q/min or <), patches of BLE dermatomes. Bilateral anterol... Read more
Lower back and left leg spasms (LLE spasms q/min or <), patches of BLE dermatomes. Bilateral anterolateral thigh muscle burning sensation during prolonged exertion. Difficulty standing from a crouched position. G.U. Urgency. Symptoms similar to viral transverse myelitis diagnosed in 2013
60 2021-04-27 weakness Injection site soreness, tiredness on 4/27/21. At 2 a.m. on 4/28/21 woke up with chills, sweats, fe... Read more
Injection site soreness, tiredness on 4/27/21. At 2 a.m. on 4/28/21 woke up with chills, sweats, fever of 102, headache, muscle pain, joint pain, nausea, feeling unwell, dizziness, weakness, injection site soreness, somewhat fast heartbeat, shortness of breath. If he talked then short of breath and would cough. About 8 a.m took 1 Tylenol. About 9:30 a.m. had major stomach cramps, barely walk but made to bathroom to throw up. Used cold wash cloth for his fever then after he threw up he ate one piece of toast, took his medications and 1 Tylenol (since he threw up the first one). Heart rate better and breathing better. Went back to bed to go to sleep about 10:30 a.m.
60 2021-04-27 burning sensation After first and second night had 101 F fever. Rash started on back as mild faliculitis, now has spre... Read more
After first and second night had 101 F fever. Rash started on back as mild faliculitis, now has spread to cover a large portion of his back and to his legs and arms. The rash appeared the 3rd day after the vaccine. Rash is very itchy and burns/stings. PCP gave prednisone - may have helped a little but has now quit responding. Will begin tapering.
60 2021-04-27 severe one side paralysis Stroke from blood clot. .Surgical thrombectomy . After initial full paralysis on left side, not adv... Read more
Stroke from blood clot. .Surgical thrombectomy . After initial full paralysis on left side, not adverse effects.
60 2021-04-27 pain in extremity pt says his arm was sore the day after taking the vaccine but now the soreness has spread from the t... Read more
pt says his arm was sore the day after taking the vaccine but now the soreness has spread from the top of his left shoulder down to his fingers. He says it hurts from the skin to the bone. He cannot lay down, he has to sleep sitting upright. he said the pain is constant but is not as bad when he sits up and when he lays down the pain is so bad he has to get back up. He is taking aspirin for his pain.
60 2021-04-28 discomfort Sharp pain in right side of abdomen near appendix; bloating; distended abdomen; flatulence. Discomfo... Read more
Sharp pain in right side of abdomen near appendix; bloating; distended abdomen; flatulence. Discomfort began 3 hours post vaccine. Peak discomfort lasted for 10 hours. Subsided overnight. Almost gone 20 hours post vaccine. Alka Seltzer & Tums
60 2021-04-28 numbness, feeling of body temperature change, tingling After first dose-Numbness and tingling that started in the left jaw area, moved into era and throat,... Read more
After first dose-Numbness and tingling that started in the left jaw area, moved into era and throat, then moved up to the scalp on the left side only. (I thought I was getting shingles) Pricking sensation in left arm. After second dose tingling and numbing in different parts of the body with pricking at different time ALL over my body randomly. Sometime feeling of cold and other times the feeling of heat. It takes 1-3 day to subside and as it subside I get an itchy feeling. Comes back what seems to be every 2 weeks. It is like my nerves are "firing off", again, all over and randomly.
60 2021-04-28 migraine Severe headache/migraine
60 2021-04-29 tremor, seizure, speech disorder On 4/28, I was feeling some side affects like tired, body pain and joint stiffness . I work at home... Read more
On 4/28, I was feeling some side affects like tired, body pain and joint stiffness . I work at home and I was finished with work at 7pm. My legs felt like led weights and my right hand had lots of joint pain. I ate supper at 7pm. It was getting towards 8pm and was starting to have signs that Unintentional tremors. shaking in my legs, hands and head. I laid in bed and it was far worse, this was a seizure. was having hard time speaking or breathing at times. I managed to take a clonazepan and with in a hour it starting to calm down.
60 2021-04-30 pain in extremity Muscle pain and rash at injection site, both lasting for 3-4 days. Body and joint aches lasting 1 1... Read more
Muscle pain and rash at injection site, both lasting for 3-4 days. Body and joint aches lasting 1 1/2 days. Feeling of being too warm, tiredness and chills lasting 1 1/2 days. Did not seek treatment since I knew these were normal reactions that would subside. Most of the side effects only lasted a day and a half except for the arm soreness and rash at the injection site which lasted 3-4 days.
60 2021-05-02 slurring 4 days after 1st shot my husband became ,confused,garbled ,speech,,did not know who the president wa... Read more
4 days after 1st shot my husband became ,confused,garbled ,speech,,did not know who the president was or what year it was.admitted to Hospital .Released with a diagnosis of TIA.Went back to work .Sent home due to garbled speech and confusion .Second shot given.Sick for 10 days .Fever 101,diarrhea ,slurred speech ,confusion .awaiting to get second MRI.
60 2021-05-02 numbness Sudden bilateral leg weakness a little over 2 weeks from vaccine dose. Also had the inability to wal... Read more
Sudden bilateral leg weakness a little over 2 weeks from vaccine dose. Also had the inability to walk. Bilateral increasing numbness to both arms and legs. Progressive weakness. Admitted to hospital. Had CT scan, MRI scan, LP puncture, blood work. Findings/lab work state GBS (Gillian Barre syndrome)
60 2021-05-02 pain in extremity Fever lasted 2 days, headache lasted 3+ days, chills lasted 2 days, body aches lasted almost 2 days... Read more
Fever lasted 2 days, headache lasted 3+ days, chills lasted 2 days, body aches lasted almost 2 days, sore arm lasted 2-3 days. Took 500mg Acetaminophen one time about 23 hours after symptoms began.
60 2021-05-02 seizure Patient first presented with extreme nausea, vomiting and dizziness about 30 minutes after his secon... Read more
Patient first presented with extreme nausea, vomiting and dizziness about 30 minutes after his second dose. Another 15 minutes later as he has a seizure and then was still very delirious. Ambulance was called but patient refused to go to the hospital.
60 2021-05-04 slurring, weakness Originally went to ER, they diagnosed it as torticollis. They sent me to my PCP who confirmed it. ... Read more
Originally went to ER, they diagnosed it as torticollis. They sent me to my PCP who confirmed it. I had violent & severe neck pain and severe headaches. Also an extremely stiff neck where I couldn?t turn it 1/8th oh an inch to either side. It all got so severe that I didn?t eat for days at a time and was literally not with it. Couldn?t respond when spoken to, and became excessively weak where I couldn?t walk w/o help, and speech was slurred. It all lasted 5 days where it was so severe. With medication it slowly began to back off.
60 2021-05-04 feeling cold, numbness, pain in extremity, tremor Fever; felt like trash and didn't feel good at all; both of his pinkies down to his wrist were numb;... Read more
Fever; felt like trash and didn't feel good at all; both of his pinkies down to his wrist were numb; Got really winded; didn't have any oxygen; Got really winded; didn't have any oxygen; Uncontrolled Chills; he was shaking like crazy and he couldn't get warm enough; Sore Right Arm after Second Dose; he was shaking like crazy and he couldn't get warm enough; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (BNT162B2), dose 2, administered in arm right on 14Apr2021 09:50 (Batch/Lot Number: EW0158) as single dose at the age of 60-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were none. The patient received bnt162b2 (BNT162B2), dose 1, administered on 18Mar2021 09:50 (Batch/Lot Number: EN6208) as single dose at the age of 60-year-old for COVID-19 immunisation and experienced on 18Mar2021 17:10 left arm hurt and on 19Mar2021 felt really fatigued, recovered on 25Mar2021 and 20Mar2021 respectively. No additional vaccines administered on same date of the Pfizer suspect. On 14Apr2021 22:00 the patient experienced got really winded; did not have any oxygen, uncontrolled chills, sore right arm after second dose, he was shaking like crazy and he could not get warm enough, he was shaking like crazy and he could not get warm enough. On 15Apr2021 the patient experienced 102 degree fever fever, felt like trash and did not feel good at all, both of his pinkies down to his wrist were numb. The course of events was as follows: On 14Apr2021 after his second shot that evening around 10:00 P.M., he had uncontrollable chills. He could not hold a cup of water without spilling it. He fought that off and it calmed down and he fell asleep. The next morning on 15Apr2021 he felt like trash and did not feel good at all and he had a 102 degree fever. He took Advil as treatment and one hour later he sweated that out and his fever went away then. Both of his pinkies down to his wrist were numb for the rest of the day and the next morning, his left hand was already feeling back to normal, and his right hand took the rest of the day and it got back to normal. No event required a visit to Emergency Room or physician office, but he almost went to the ER with the second dose because he was shaking like crazy and he couldn't get warm enough, but finally it wore off. It got to a point where he did not have any oxygen, he was shaking that bad. When he went up the stairs, he got really winded and sat and down. It lasted at least an hour, during that time he was awake he was trembling bad and couldn't get warm. When he quit shaking, he fell asleep. Patient stated his wife mentioned something about they gave him some tests, like COVID Experimental Drugs, when he was in hospital for 12 days. He could not even tell the names of them. That was 15-27Oct2020. He did not know if that has anything to do with his reaction. The outcome of got really winded; did not have any oxygen, he was shaking like crazy and he could not get warm enough was recovered on 14Apr2021, of uncontrolled chills, fever, was recovered on 15Apr2021, of sore right arm after second dose, both of his pinkies down to his wrist were numb, felt like trash and did not feel good at all was recovered on 16Apr2021.
60 2021-05-06 pain in extremity Feeling terrible all over; aching all over; his urine started smelling bad; Hepatitis C; His chest w... Read more
Feeling terrible all over; aching all over; his urine started smelling bad; Hepatitis C; His chest was also hurting; Dizzy; his arm hurt just from the shot.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient (weight: 83.91 kg, height: 178 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8734, Expiration date: 31Jul2021) at single dose, in the right upper arm, on 10Apr2021 at 14:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included arachnoiditis adhesive chronic from an unspecified date, in 1999 and ongoing, ulcerative colitis from an unspecified date, in 1996 and ongoing, chronic sinusitis from an unspecified date, venous reflux disease from an unspecified date and ongoing and polyps from an unspecified date (7 surgeries performed from polyps. Last surgery was Mar2016). The patient preciously, on 20Mar2021, at 14:00, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EP7534, Expiration date: 31Jul2021) in the right deltoid, at single dose, on for COVID-19 immunisation. He was good after the first shot, he had no problems. Concomitant medications were unknown. On 10Apr2021, the patient experienced dizzy ("after the second dose they got home and that evening while getting up off the couch, he got really dizzy") and his arm hurt just from the shot. On 13Apr2021, he developed chest pain (his chest was also hurting) and had hepatitis C ("he got blood work done and just got it back and was told he has hepatitis C"). On 20Apr2021, his urine started smelling bad. On an unspecified date, the patient also experienced generalised aching ("aching all over") and was feeling terrible all over. Relevant laboratory test, performed on an unspecified date, showed the following value: alkaline phosphate high, blood cholesterol high, eosinophil count 5.4 %, hepatitis C positive, low density lipoprotein (LDL) high and infectious mononucleosis (Mono) 13.5. The patient recovered from vaccination site pain on 10Apr2021, recovered from dizzy on 14Apr2021 and recovered from chest pain on 20Apr2021. The patient did not recover from hepatitis C and urine abnormal. Clinical outcome of feeling bad and generalised aching was unknown at time of this report.
60 2021-05-06 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
60 2021-05-07 bell's palsy Bell's Palsey; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old ... Read more
Bell's Palsey; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8734) in the left arm on 01Apr2021 at 13:00 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history was none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included loratadine (CLARITIN) and fexofenadine hydrochloride (ALLEGRA). The patient previous received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204) on 11Mar2021 at 14:00 (at the age of 60-years-old) in the left arm for COVID-19 immunization. There were no other vaccinations within 4 weeks of the vaccine. On 04Apr2021 at 12:00 (reported as 3 days after the second vaccination), the patient experienced Bell's Palsy and it was difficult to close the left eye and move the left side of his mouth. The patient visited a doctor or other healthcare professional because of this event. It was unknown if the patient received treatment for the event. Since the vaccination, the patient was tested for COVID-19 via a molecular nasal swab on 15Apr2021 with negative results. The clinical outcome of Bell's Palsy was not resolved.
60 2021-05-07 numbness TIA symptoms. Facial numbness
60 2021-05-07 muscle spasms Losing strength in his right leg; Muscle pain; Joint pain; Muscle spasms in his neck because he has ... Read more
Losing strength in his right leg; Muscle pain; Joint pain; Muscle spasms in his neck because he has neck pain too; Muscle spasms in his neck because he has neck pain too; His leg kept getting worse; He just cant walk anymore; Leg is swollen; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A 60-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: ER6208) as single dose at the age of 60-year-old for COVID-19 immunisation. Medical history included disability. The patient's concomitant medications were not reported. The patient experienced losing strength in his right leg in Mar2021, his leg kept getting worse in 2021, he just can not walk anymore in 2021, leg is swollen in 2021, muscle pain in Mar2021 with, joint pain in Mar2021, muscle spasms in his neck because he has neck pain too in 2021. The events losing strength in his right leg, his leg kept getting worse, he just can not walk anymore and leg is swollen were assessed medically significant. The patient underwent lab tests and procedures which included magnetic resonance imaging: leg is swollen in 2021, X-ray: nothing showed up in 2021. Therapeutic measures were taken as a result of losing strength in his right leg, muscle pain, joint pain. The course of events was as follows: Around 21 Mar2021 or 22Mar2021, he had problems with his leg. Patient was experiencing muscle pain and joint pain, losing strength in his right leg. Patient stated that was a problem. Patient had an MRI and X-ray that looked to see what the problem was. Patient received second dose on 14Apr2021. Patient hasn't even seen his prescribing Healthcare Professional yet, until Monday. He hasn't worked in five years, he's been on disability. He wanted to get off disability so he went and got a job. He started the job 28Mar2021 and everyday, his leg kept getting worse. He had to leave the job the other day because he just cant walk anymore, he has to do a lot of walking on the job. He called the doctor and told them something was wrong with his leg, they took an x-ray and nothing showed up. They did an MRI and all it shows was that his leg was swollen, no bones or nothing is broken. He was looking at Pfizer paperwork that a facility gave him and the two of symptoms are on there, so this problem was related to the vaccine. He never hurt his right leg, never had a problem until he got this shot. He was losing all his strength in his right leg, all the pain. They have been giving muscle relaxers and ibuprofen and they did not seem to work or be doing anything. First, he went to the emergency room and they gave him Ibuprofen 600 mg tablets and they gave him Cyclobenzaprine 10mg tablets. They said that he was experiencing muscle spasms in his neck because he has neck pain too. So he made an appointment with his family doctor, which there was no openings and had to see another PA. He did not know the HCP last name, but he/she was a PA in the office and he saw him/her, who requested the x-ray, and he had the x-ray done and saw him/her again and nothing showed up so he/she requested an MRI. He went to the hospital to have that and nothing showed up except his leg was swollen. Now they are going to send him to a bone specialist, but there was no reason to because now he stated he knew what was causing this. Patient took Cyclobenzaprine, 10 mg, three times a day by mouth. He states it did not seem to do nothing. Patient verified it was a prescription from the pharmacy: NDC: 0137517-19674, unsure of LOT, expiry date. The quantity of the first bottle was 15 but he went through that already and he got a new bottle that has 42 in it. This current bottle he has 12 or 13 left. The first bottle was completely gone. Patient took Baclofen 5mg tablets, three times a day: morning, noon, and night. They were not doing anything either, well he did not think they are. Patient provided NDC: 0135391-19674. The first muscle relaxer they gave him, the 10mg one, he took it that day, it knocked him out. Caller states when he saw his doctor, he said he can not take that one while he works, he will take it at night time, so that is why the doctor gave him the other muscle relaxer, Baclofen, to take while he worked during the day. He took one muscle relaxer at night of one kind and the other kind he takes the ones that won't take him out as much. Patient stated that he had to leave his job because he cannot do it, he cannot walk. Patient took Ibuprofen (NDC: 0139246-19674, to use before 22Apr2022) 600mg, by mouth, three times a day. He took one with the muscle relaxers. Patient took verified all medications Cyclobenzaprine; Baclofen; Ibuprofen were prescriptions from the pharmacy. The outcome of muscle pain and joint pain, losing strength in his right leg, his leg kept getting worse, was not recovered of he just can not walk anymore on, leg is swollen, neck pain was unknown. Reporter seriousness for muscle pain and joint pain, losing strength in his right leg and neck pain was unspecified Patient received his second dose of Pfizer Covid 19 Vaccine (LOT: EW0161, unsure if ER or EW) on 14Apr2021. A Product Complaint was filed. No follow-up attempts are needed. No further information is expected.
60 2021-05-07 paralysis had a stroke that left him paralyzed; had a stroke that left him paralyzed; This is a spontaneous re... Read more
had a stroke that left him paralyzed; had a stroke that left him paralyzed; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Apr2021 at 09:45 (lot number: EW0158) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no 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 prior to vaccination. On 27Apr2021 at 11:15, the patient had a stroke that left him paralyzed. The events resulted in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The events were considered serious (hospitalization, disability, life threatening). Therapeutic measures were taken as a result of the events which included full stroke treatment (as reported). The patient had Covid-19 nasal swab test with unknown results on 27Apr2021. The outcome of the events was recovered with sequel. No follow-up attempts are needed. No further information is expected.
60 2021-05-09 slurring Admitted 04/30/2021 for increasing slurred speech and confusion; previously admitted to outside faci... Read more
Admitted 04/30/2021 for increasing slurred speech and confusion; previously admitted to outside facility 04/15/2021 through 04/19/2021 for similar symptoms
60 2021-05-09 seizure Wife says I have had seizures at least twice just after falling asleep
60 2021-05-10 muscle spasms leg cramps in upper leg; muscle aches in his upper legs at night; This is a spontaneous report from ... Read more
leg cramps in upper leg; muscle aches in his upper legs at night; This is a spontaneous report from a contactable consumer (patient's sister). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer said the patient took the COVID shot, and has taken the second shot and on his first one had muscle aches in his upper legs at night, the second shot didn't bother him. She said that with the first shot he had some leg cramps at the top of his legs at night and that was it. He had it for like 2 nights and then it went away. She stated that she didn't know his age when he got the 1st vaccine because she didn't know when he got it, but that it was sometime in March (Mar2021). She stated he did receive the vaccine at hospital. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained
60 2021-05-11 pain in extremity, numbness 2 hours after, tiredness, next morning soreness in arm, insomnia, numb face for 3 days, loss sense o... Read more
2 hours after, tiredness, next morning soreness in arm, insomnia, numb face for 3 days, loss sense of taste
60 2021-05-12 bell's palsy Patient reported developing Bell's Palsy 3 days after first dose.
60 2021-05-13 pain in extremity About 1 week following first Pfizer vaccination, I began having achiness in left leg and thought thi... Read more
About 1 week following first Pfizer vaccination, I began having achiness in left leg and thought this was possibly from sitting in a chair without enough cushion. I simply could not get leg comfortable. Over a couple days duration the leg continued to be achy and slightly swollen. On December 23rd at night I awoke due to such discomfort in leg and could not get comfortable enough to go to sleep. I went to ED where I was examined and found to be mildly short of breath and in pain. Ultrasound of leg showed large upper leg DVT. CT of chest showed submassive Pulmonary Horseshoe Embolus. I was placed on Heparin and anticoagulated. Hospitalized for several days while anticoagulated and observed for any clot progression or respiratory distress and discharged home on Xarelto for anticoagulation and follow up with PCP, Hematology, Pulmonary medicine.
60 2021-05-14 bell's palsy Three weeks after my second shot, I developed Bells palsy, and virus attacked right side of my face;... Read more
Three weeks after my second shot, I developed Bells palsy, and virus attacked right side of my face; virus attacked right side of my face; This is a spontaneous report received from a contactable consumer (patient). A 60-years-old male patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 15:15 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included meniere's disease from Oct2020 to an unknown date. There was no known allergy. The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER COVID-19 VACCINE), on 13Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization and experienced vertigo. Three weeks after his second shot, the patient developed Bells palsy, and virus attacked right side of his face at 27Apr2021 07:30 AM. These events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. This event did not result in death, cause/prolonged hospitalization, was not life threatening, disabling/incapacitating, congenital anomaly/birth defect. Treatment for the events included Zaltrex - antivirus, Prednisone. The patient did not have covid prior vaccination. The patient was covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
60 2021-05-14 tremor, speech disorder, seizure, weakness This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient re... Read more
This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 27Apr2021 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing tremors and prostate issue. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included clonazepam, tamsulosin, oxybutynin. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 27Apr2021 (the first day), the patient was a little tired. On 28Apr2021 (the second day), the patient experienced joint pain, felt very tired and weak. By 19:00-20:00, the patient realized he was going to have a tremor attack, but quickly turned into what would be called a seizure. The patient lost motor skills, speaking and breathing issues accrued. The symptoms where coming and going. With the help of his wife, the patient managed to take one 0.5 mg clonazepam. The situation lasted for around an hour, after which the patient went to bed. The next morning, 29Apr2021, the patient still had a lot of joint and muscle pain. As soon as he tried to start some minor work around the house, the tremors started again, but this time the patient took clonazepam and rested in bed all day. Today, 30Apr2021, the patient was tired from the situation and will be resting also. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of seizure, " tremor attack / tremors started again", joint pain, tired, weak, lost motor skills, speaking and breathing issues accrued and muscle pain was resolving. Information about lot/batch number requested.
60 2021-05-16 feeling hot Immediately after the injection I felt a warm sensation flowing through my body and my head felt war... Read more
Immediately after the injection I felt a warm sensation flowing through my body and my head felt warm but I did not have a temperature. This subsided within 20 minutes. Prior to the vaccination I had slight Tinnitus on a scale of 1-10 I would say it was a 2. I had no trouble sleeping at night and did not use any sound machines to mask the tinnitus. I would characterize myself as a great sleeper. About 48 hours after the vaccination in my left ear my Tinnitus went from a 2 to a 5. Now to sleep I must run a fan or noise machine to mask the tinnitus and sometimes have to take benadryl or Tylenol PM to sleep.
60 2021-05-16 pain in extremity, sciatica On April 14, 2021 at 2:15 AM, I woke up with severe pain in my lower right calf/ankle. Unable to bea... Read more
On April 14, 2021 at 2:15 AM, I woke up with severe pain in my lower right calf/ankle. Unable to bear weight on right leg. Reduced to crawling around house on hands and knees. Went to former Primary Care Physician on 4//14/21, where I was treated for Sciatic Nerve flare up. Returned to Dr on 4/19/21 in severe severe pain. Dr referred me to hospital where I was again treated for Sciatic related symptoms. Symptoms worsened daily. On April 28, 2021, I crawled into Hospital, was admitted. Received injection in spine. Symptoms worsened. Changed Primary Care Physicians to Dr on 4/11/21.
60 2021-05-18 muscle spasms, tingling leg cramping and weakness, tingling and pins-needles head and face
60 2021-05-20 tremor, seizure, flushing Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Systemic: Sh... Read more
Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: At this point in time, patient was taken by paramedics and they took him to the local hospital. Additional symptoms,issues, or outcome unknown.
60 2021-05-21 weakness, unresponsive to stimuli, feeling hot Patient felt fine after shot, then started feeling weak, hot, lightheaded, then lost consciousness. ... Read more
Patient felt fine after shot, then started feeling weak, hot, lightheaded, then lost consciousness. Tapped patient, yelled his name, called 911, monitored breathing and blood pressure, provided him water, banana, oragne juice when he woke and waited for Ems. He left with ems but was feeling much better.
60 2021-05-21 pain in extremity Sore arm, diarrhea
60 2021-05-22 weakness Pt was admitted on 5/10/21 c/o of rigor. Patient complains of fatigue, weakness, intermittent fever... Read more
Pt was admitted on 5/10/21 c/o of rigor. Patient complains of fatigue, weakness, intermittent fevers up to 100.8 °F. EMS found patient to be hypotensive up to 84/52 and tachycardic up to 120s per minute. He woke up the morning of admission and then began to have shaking rigors at 10 AM and felt profoundly fatigued, dizzy and lightheaded. Patient does have a history of COPD which is non-O2 nonsteroid dependent and has some chronic shortness of breath. He does use inhalers and nebulizers and also continues to smoke. He also has a history of melanoma who follows with provider. In the ER he was found to have hypotension and was given 2 L of IV fluids. He also had a 3 g drop in his hemoglobin over the past 5 days and there was concern for a possible upper GI bleed. Because of the hypotension and drop in hemoglobin he was admitted to the ICU. He was started on Protonix IV. Chest x-ray, CT of the chest CT of the abdomen and pelvis were unremarkable for any acute process. He was admitted for unspecified shock which was initially thought possibly due to sepsis but this was ultimately ruled out. He was treated with 5 days of vancomycin and Zosyn and then antibiotics were discontinued. Patient's troponin was elevated with an elevated delta. He was seen In consultation by cardiology who felt that no further cardiology work-up was needed the cause for the patient's hypotension was unclear but his home lisinopril was discontinued. he did require albumin but not pressor support. As he was more stable he was transferred out of the ICU to the medical floor. He was started on midodrine. His blood pressure has improved he has remained afebrile throughout his hospital course he has remained stable off antibiotics. At this time he is medically stable for discharge to home and will continue on midodrine for new autonomic failure/dysfunction. the cause for his fevers/rigors was not found
60 2021-05-24 discomfort After about 4 days with a temperature of 37.7 centigrade: high blood pressure -- > systolic 190 dias... Read more
After about 4 days with a temperature of 37.7 centigrade: high blood pressure -- > systolic 190 diastolic 115 (despite Ramipril 5mg morning and evening) Vertigo Acufene General discomfort duration of symptoms: 5 days
60 2021-05-24 electric shock sensation Pt described feeling a feeling similar to Pop Rocks but in his brain. Describes the sensation as lig... Read more
Pt described feeling a feeling similar to Pop Rocks but in his brain. Describes the sensation as lightning bolts in his brain. Pt denies any vision changes, hearing changes, light headedness or dizziness.
60 2021-05-24 muscle spasms Left arm, Epilepsy (Parkinsons) Can?t lift arm, muscles cramp, hurts under his arm, never had this p... Read more
Left arm, Epilepsy (Parkinsons) Can?t lift arm, muscles cramp, hurts under his arm, never had this problem before, Received Moderna May 20th. Takes blood thinner depakote and triacetone,. Being seen by Health Department.
60 2021-05-25 tingling, flushing, feeling hot Per triage notes on 4/21/21: Pt had his 2nd COVID vaccine today at 0800. At 0900 developed lip swell... Read more
Per triage notes on 4/21/21: Pt had his 2nd COVID vaccine today at 0800. At 0900 developed lip swelling. Took two doses of Benadryl and has now developed chest tightness and throat swelling. Per doctor's notes: Patient is a very pleasant 60-year-old gentleman who comes in for evaluation after a possible allergic reaction today, possibly related to a second dose of Pfizer Covid vaccine that he got at 8 AM this morning. About an hour later he started to feel flushed. He felt like his face was warm and his ears were warm. He started to feel like the inside of his mouth had filled with a rubber ball. His tongue felt full and he started noticed progressively that he felt like he was having difficulty swallowing. States that he never actually had any lip swelling, contrary to the triage note, just felt funny in the interior of his mouth. Did feel like his tongue was slightly swollen, both based on the fact that it felt "thick" when he was talking, and on direct inspection, as well. Took 50 mg of Benadryl around the time that his symptoms started, and lay down to nap for a little while. When he woke up he was still feeling like he was having more difficulty swallowing. He also felt like his face was a little bit puffy, prickly under each eye. He also felt like he had a blotchy rash on his chest and upper back, which his wife corroborates. He felt like his chest was a little bit tight and that something was heavy on his chest, though he was not wheezing or acutely short of breath, per se. Took another 50 mg of Benadryl at about 2:15 PM, and presented to the emergency department for further evaluation. Currently still has a little bit of chest tightness and throat tightness. He feels flushed. Symptoms have not worsened, but they have not completely resolved, either. He has had anaphylaxis in the past and has had to be admitted to the hospital. And this was in relation to taking doxycycline, it sounds like. Patient presented again to the ED on 4/22/21 with the same symptoms. He was admitted with anaphylaxis. Per ED notes, also diagnosed with Angioedema, improved. Likely related to second covid vaccine. Cant rule out secondary to Lisinopril.
60 2021-05-26 tingling, numbness Injection given in left upperr arm. About a week or so later I started to get tingling on my left pa... Read more
Injection given in left upperr arm. About a week or so later I started to get tingling on my left palm. This was sporadic at first, but it is getting more common (ie all the time, with some slight numbness) as well as tingling in my pinky and ring fingers. I have not had any trauma or other change in circumstances that would be a reason for having the tingling. I am not on any other meds nor do I use alcohol. I am concerned that this might be a reaction to the vaccine and for this reason I am hesitant to have a second dose. Please advise.
60 2021-05-27 tingling, difficulty speaking, numbness, inability to speak Post vaccination at approximately 10:30 am client reported feeling numbness and tingling in hands, d... Read more
Post vaccination at approximately 10:30 am client reported feeling numbness and tingling in hands, developing a cough and a subsequently developing a felling of throat "closure" or tightness. Client was evaluated by Emergency response team and relocated to the Emergency response tents. At 10:45 am client was noted to become hoarse and requiring neck extension to swallow water. Client at this point was reported to be unable to speak in full sentences. Epinephrine was administered by Emergency Response physician at 10:50 AM. EMS was on site, oxygen was administered and transport to a nearby hospital emergency room was initiated and completed. Note: In retrospect client stated that he had similar symptoms after his first intramuscular vaccine dose (Pfizer, three weeks prior) for three days and had self medicated with Benadryl but had subsequently felt better.
60 2021-05-27 tingling 21 days after my 2nd Pfizer shot in my Left Arm, I started having an on going "tingling" sensation ... Read more
21 days after my 2nd Pfizer shot in my Left Arm, I started having an on going "tingling" sensation from my left elbow down into my left hand. Now after 2+ days I still have a tingling sensation.
60 2021-05-28 muscle spasms, pain in extremity Headache; Aches/pains,aches/pains, especially of back,; Aches/pains,aches/pains, especially of back,... Read more
Headache; Aches/pains,aches/pains, especially of back,; Aches/pains,aches/pains, especially of back,; Nausea; Cramps; Fatigue; Felt worse next day with arm pain; This is a spontaneous report received from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administration in Arm Left on 03Mar2021 10:30 (at age of 60-year-old) as a single dose for covid-19 immunisation. Medical history included high cholesterol, High blood pressure and General anxiety from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, losartan, alprazolam and xanax only as needed. The patient had no allergies to medications, food, or other products. The patient experienced headache, aches/pains, especially of back, nausea, cramps, fatigue; felt worse next day with arm pain on 03Mar2021. The events assessed as non-serious. No treatment was received for the events. 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, did not patient been tested for COVID-19. In pharmacy or drug store most recent COVID-19 vaccine was administered. The outcome of the events was reported as recovered on unknown date. Follow up: This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: The patient told reporter about the event on 3Mar2021 (day of vaccination) and PRD for initial report updated to 03Mar2021 accordingly. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
60 2021-05-29 cold sweat EE called hotline stating he received a call from Urgent Care that he has a POSITIVE covid test resu... Read more
EE called hotline stating he received a call from Urgent Care that he has a POSITIVE covid test result from 5/28/21. He was called from Urgent Care providers. EE symptomatic. EE went on his own on 5/28 to Urgent Care and was swabbed. EE was not swabbed through EH hotline. Results not available on Epic. EE called dls and Urgent Care for a copy of his results, but they have not given it to him. Instructed EE to email a copy of positive covid results to Employee Health and covid surveillance. EE to update manager. Spoke with nurse at Urgent Care who verified that EE is Covid Positive. States she will email the results. EE states he is fully vaccinated, last dose on 1/13/21. EE states he is not a part of the SARS study, but he would like to do the antibody blood test. EE to do antibody testing after quarantined. Orders placed and instructions given to EE to obtain blood test at DLS. Instructed EE he will need to isolate & quarantine at least 10 days and/or until symptom free. EE to call hotline when he is released from DOH and to update us on his symptoms. HISTORY 5/28/21: EE stated he woke up with sore throat, feeling lethargic, fever, and cold sweats today 5/28/21. EE stated he went to Urgent Care on his own today, swabbed for strep which was negative and swabbed for covid; awaing covid test results. EE instructed to quarantine while results pending; if negative no longer needs to quarantine. EE instructed to call the hotline with his results. EE informed when he calls hotline, he will be given further guidance for clearance and will be asked to email the results to employee health. EE informed to keep his manager updated.
60 2021-06-01 pain in extremity Sore arm, headaches, painful and swollen lymph node on left side under left ear -- still swollen and... Read more
Sore arm, headaches, painful and swollen lymph node on left side under left ear -- still swollen and painful after 3 months since the first injection.
60 2021-06-02 pain in extremity Very painful left arm pain. location where shot was given there is a lump under the skin. The pain i... Read more
Very painful left arm pain. location where shot was given there is a lump under the skin. The pain is still going on when raising my are or supporting weight on it. . My Fiancée also had the shot in her arm before I did and her arm as well is having site pain. She had the same shot that I did at pharmacy.
60 2021-06-02 seizure Patient here for 2nd dose of Pfizer Covid-19 vaccine. No h/o allergies or significant medical histor... Read more
Patient here for 2nd dose of Pfizer Covid-19 vaccine. No h/o allergies or significant medical history. LPN arrived on scene after vaccinator was yelling for help. Patient was "in and out of consciousness", awake and alert and then would have LOC for a few seconds and then become awake and alert again. This happened about 4 times with LOC with also some "convulsing like movements in the arms". Emergency responders and clinical lead, RN called. Patient laid back in seat as far as the seat would go, face pale and lips white. Pulse-ox put on and BP taken, 36 bpm (according to pulse-ox) and oxygen level 89%, BP 100/54. LPN gave epinephrine injection at this point at 1151, 0.3mg IM in right thigh. HCP arrived on site, patients VS after epi: pulse 76, 100/76, O2 sats 94% at 1155. Patient awake and alert, oriented to person, place and time. Lips and face pink. Care turned over to Paramedics who arrived on site at 1200.
60 2021-06-03 hot flush HAD PHIZER VACCINE: HEADACHES, CHILLS, HOT FLASHES, NAUSEA, SLIGHT TEMPERATURE. STARTED AT 6:00... Read more
HAD PHIZER VACCINE: HEADACHES, CHILLS, HOT FLASHES, NAUSEA, SLIGHT TEMPERATURE. STARTED AT 6:00PM DAY OF VACCINE AND TODAY IS FRIDAY THE 4TH AND I STLL HAVE HEADACHE
60 2021-06-03 night sweats TIA; Swollen lymph nodes in chest and abdomen; enlarged spleen; fever; night sweats; exhaustion; Thi... Read more
TIA; Swollen lymph nodes in chest and abdomen; enlarged spleen; fever; night sweats; exhaustion; This is a spontaneous report from contactable consumer. This 60-years-old male consumer(patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: unknown) at single dose for COVID-19 immunization on 03Apr2021. Relevant history and concomitant drugs were unknown. 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 experienced TIA (Transient ischaemic attack), Swollen lymph nodes in chest and abdomen, enlarged spleen, fever, night sweats, and exhaustion. Emergency room/department or urgent care was need, the patient was hospitalized due to the events. Outcome of events was not resolved. The patient was very sick in the hospital per patient's wife. The patient had SARS-CoV-2 test (Nasal Swab) in Apr2021 (After post vaccination) with negative result. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-06-06 inability to speak, pain in extremity Normal reactions sore arm -fatigue lasted 3 days 3 weeks later he was getting some brain fog ... Read more
Normal reactions sore arm -fatigue lasted 3 days 3 weeks later he was getting some brain fog and little confusion 2nd shot fatigue- sore arm which lasted a week more brain fog more confusion couldn't get his words out. could not work his phone or computer Went to doctorMay 24th
60 2021-06-06 weakness 24 Hours after - completely dibilitating lasted for 2 days. gradual recover to being able to so... Read more
24 Hours after - completely dibilitating lasted for 2 days. gradual recover to being able to somewhat function but still dizziness - vertigo - always a little bit but massive if moving head rapidly,
60 2021-06-07 numbness About 4 hours after the vaccine my left eye started to get very red & swollen; About 4 hours after t... Read more
About 4 hours after the vaccine my left eye started to get very red & swollen; About 4 hours after the vaccine my left eye started to get very red & swollen; Numbness on the left side of my face; Swelling on the left side of my face; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 60-years-old male patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 07Mar2021 at 12:30 as SINGLE DOSE for covid-19 immunization (Facility type vaccine: Pharmacy or Drug Store). The patient's mdical history was reported as none. Patient has been not taking any other vaccine in four weeks. And no other medications in two weeks. Patient has not tested covid-19 positive prior to vaccination. Patient has no known allergies. It was reported as on 07Mar2021 at 04:30 PM about 4 hours after the vaccine his left eye started to get very red and swollen along with some numbness and swelling on the left side of his face. Four hours later it was started to get better with cold compress. Patient has not tested covid-19 positive post vaccination. The outcome of the events was reported as resolving. No follow-up attempts are possible. No further information is expected.
60 2021-06-08 tremor 20 hours after shot i became very dizzy and confused i made it to my bed were i slept interrupted wi... Read more
20 hours after shot i became very dizzy and confused i made it to my bed were i slept interrupted with night terrors' upset stomach and shaky legs this continued for two days 5 days later i became strong enough to continue with daily activities
60 2021-06-12 numbness, tingling Pt reported experiencing tingling on left side of face, arm, fingers leg and toes. Tingling progres... Read more
Pt reported experiencing tingling on left side of face, arm, fingers leg and toes. Tingling progressed to numbness on the fingers.
60 2021-06-13 pain in extremity Body aches, sore arm & slight fever 99/100 for one day
60 2021-06-14 pain in extremity A few days after his second dose he developed left neck, left arm, and left thigh pain. He described... Read more
A few days after his second dose he developed left neck, left arm, and left thigh pain. He described it as a burning pain and a poking pain. It felt exactly like his post-herpetic neuralgia from 2019 - which he developed after herpes zoster.
60 2021-06-15 burning sensation, tingling Burning sensation started on back of neck - intense sunburn feeling. Later on arms, hands, feet an... Read more
Burning sensation started on back of neck - intense sunburn feeling. Later on arms, hands, feet and back. Also pins and needle feeling. Started taking Advil and Benadryl. Helped a little. Moved to Advil and Zyrtec during the day. The intensity varies during the week. To a little sunburn feeling to more intense on other days. Been doing on for two months now.
60 2021-06-15 hypersensitivity of all senses Commencing approximately 18 hours after the vaccination (which was my second Pfizer vaccine), I deve... Read more
Commencing approximately 18 hours after the vaccination (which was my second Pfizer vaccine), I developed a rash that started under my arms and on my lower abdomen. Within approximately 4 hours the rash had spread across my chest, up my neck to the chin, around my waist and up the center of my back, and down the insides of my arms. The rash remained inflamed and red, and the skin sensitive, for approximately 72 hours before it began to fade. Within 5 days of beginning, the rash had subsided completely.
60 2021-06-15 numbness Severe shoulder pain vax site spreading to other shoulder. Numbness right side of face. Large swelli... Read more
Severe shoulder pain vax site spreading to other shoulder. Numbness right side of face. Large swelling left shoulder below vaccination site.
60 2021-06-15 pain in extremity Symptoms started when waking up on Monday 6/14; headache, muscle ache, joint pain, tiredness, sore a... Read more
Symptoms started when waking up on Monday 6/14; headache, muscle ache, joint pain, tiredness, sore arm; started taking Ibuprofen throughout the day. Tuesday 6/15 experienced fever, chills, still aches and pains, headache.
60 2021-06-16 tingling, numbness Patient developed Unilateral (Left)numbness and tingle 3 weeks post 2nd vaccination. Symptoms have ... Read more
Patient developed Unilateral (Left)numbness and tingle 3 weeks post 2nd vaccination. Symptoms have not improved. Patient says his left side is very sensitive to hot and cold now. Its his entire left side from left side of face to his foot. Describes it like a line down center of body. No prior episodes of anything like this in teh past. Says it was sudden onset . went to bed fine and woke up with it.
60 2021-06-17 pain in extremity Severe pain in left arm over 2 week; This is a spontaneous report from a contactable consumer (patie... Read more
Severe pain in left arm over 2 week; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 03May2021 12:00 (at the age of 60-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included meloxicam, pravastatin and cetirizine all taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient experienced severe pain in left arm over 2 week on 05May2021 08:00. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Unspecified therapeutic measures were taken as a result of the event on 17May2021. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was unknown.
60 2021-06-17 pain in extremity Chest pain in heart region at night progressing to pain radiating down left arm and up left side of ... Read more
Chest pain in heart region at night progressing to pain radiating down left arm and up left side of neck and slight nausea. Symptoms similar to beginning of heart attack, so went to emergency room for observation. No signs of heart attack were detected and emergency room doctor suggested follow up with heart specialist. Follow up also showed no heart attack occurred. Pericarditis not detected with stethoscope but was suspected. Pain in heart region was not severe, ~level 2, but was persistent. Heart doctor said that was not consistent with heart attack which tends to be severe but episodic. Slight pain noticeable in heart region for weeks afterward and still evident but now very slight. Not acute, but joint pain seems slightly increased after the vaccine.
60 2021-06-17 seizure Systemic: Seizure-Severe
60 2021-06-18 pain in extremity Pain in the thighs and legs, in the lower part of the buttocks; Pain in the thighs and legs, in the ... Read more
Pain in the thighs and legs, in the lower part of the buttocks; Pain in the thighs and legs, in the lower part of the buttocks; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 19Mar2021 10:00 (Lot Number: EN6207) as single dose for covid-19 immunization at the age of 60-year-old. The patient medical history and known allergies were none. Concomitant medications included atorvastatin taken for an unspecified indication, start and stop date were not reported; verapamil taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain in the thighs and legs, in the lower part of the buttocks on 20Mar2021 01:00 and resulted in visit to doctor/other health care professional (HCP) office. The outcome of the events was not recovered. Therapeutic measures for events included Prednisone. The patient further received second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 30Apr2021 11:15 (Lot Number: EW0179) as single dose for covid-19 immunisation. The patient underwent Covid Test post vaccination (polymerase chain reaction: Nasal Swab) which was negative on 07May2021.
60 2021-06-19 unresponsive to stimuli Started to have chest pains a few days after vaccine. I passed out and was unresponsive with no puls... Read more
Started to have chest pains a few days after vaccine. I passed out and was unresponsive with no pulse and breathing. Received cpr from my partner who found me on the floor at approximately 2:00am on 5/16/21. I was taken to the emergency room of the hospital and underwent extensive tests of the brain: CT scan, MRI, Angiogram, and Spinal Puncture. All tests negative. I cannot walk without a walker and have other cognitive neurological symptoms. I was discharged from hospital on 6/2/21 to sub-acute rehabilitation facility. I was discharged from rehab on 6/12/21. Neurological and neuromuscular symptoms are still present.
60 2021-06-25 difficulty speaking 1st dose of vaccine administered on 03/25/21 at 1:30 pm. Side effects: 03/25/21-03/28/21 ? pain on... Read more
1st dose of vaccine administered on 03/25/21 at 1:30 pm. Side effects: 03/25/21-03/28/21 ? pain on the site of injection; nausea. 03/26/21-04/04/21 ? increased tone of facial muscles; tiredness. 04/05/21-04/07/21 ? stomach pain; slight increase in body temperature up to 37.2 C; nausea; vomiting; muscle and joint pain in the belt region. 04/08/21-04/12/21 ? increased maximum body temperatures up to 37.8 C; temperature declined overnight to 36.7-37.2 in the morning and then rising again; change of voice; all other side effects are gone. 04/13/21-04/14/21 ? maximum body temperature decreased to 37.4 C; change of voice. 04/15/21-04/20/21 ? maximum body temperature decreased to 37.2 C; change of voice. 04/20/21 blood test results - inflammation: Erythrocyte Sedimentation Rate (ESR) 56 mm/hr SARS-CoV-2 Antibodies, Spike Protein 15.10 U/mL C-Reactive Protein (CRP) 1.06 mg/dL 04/21/21-05/08/21 ? maximum body temperature decreased to 36.7-37.0 C; change of voice persists; chest pain. Multiple rectal bleedings: 04/30/21, 05/01/21, 05/11/21, 05/12/21, 05/15/21, 05/16/21, 05/21/21, 05/22/21, 06/03/21, 06/04/21(small). Temperature is in the normal range since 05/09/21. 06/01/21 blood test results ? inflammation gone: Erythrocyte Sedimentation Rate (ESR) 10 mm/hr SARS-CoV-2 Antibodies, Spike Protein 10.10 U/mL C-Reactive Protein (CRP) 0.44 mg/dL Looking for suggestion to do or not to do second vaccine administration.
60 2021-06-26 numbness and pain in extremities Abrupt worsening of his chronic neuropathy 5 days after receiving dose 1 of COVID19 vaccine series. ... Read more
Abrupt worsening of his chronic neuropathy 5 days after receiving dose 1 of COVID19 vaccine series. (He did receive dose 2 later without any change in symptoms). Workup shows axonal polyneuropathy somewhat responsive to steroids. An alternate cause of his abrupt worsening of neuropathy not found. He was taken off of his disulfiram which he had started on fall 2020. This did not seem to help. He did show some improvement with 1g IV solumedrol daily x5 days.
60 2021-06-28 pain in extremity Vaccinated person reported pain in his hands, nausea and chest pain approximately 48 hours post seco... Read more
Vaccinated person reported pain in his hands, nausea and chest pain approximately 48 hours post second Pfizer vaccine. was diagnosed with a STEMI heart attack and then coded on April 26, 2021.
60 2021-06-29 coordination abnormal, severe one side paralysis, numbness Received 2nd dose of vaccine on 4/15/21. Reported (no feeling well 10-14 days after vaccine) Tire... Read more
Received 2nd dose of vaccine on 4/15/21. Reported (no feeling well 10-14 days after vaccine) Tired, fatigued, no energy. Symptoms worsened. Started to experience bilateral numbness in both legs, gradually moving up into arms. 4/30-5/3 developed coordination issues,. Stated, "I wouldn't be able to pass a field sobriety test." Tripping, stumbling, dropping items. 5/3 had a CT scan of brain (did not show history of stroke) Early am on 5/4 fell and lost all movement on left side. MCA occlusion removed/stent placed/brain swelling worsened. Informed by neuro team that he was experiencing more brain swelling in 24 hours than a stroke victim had in 4 days.
60 2021-06-29 pain in extremity Felt hungover; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the pat... Read more
Felt hungover; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in left arm on 10Mar2021 at 13:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether 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. Concomitant medications included pravastatin (MANUFUTURER UNKNWON), allopurinol (MANUFUTURER UNKNWON) and famotidine (MANUFUTURER UNKNOWN) all for unknown indication and from an unknown date. On 11Mar2021 at 09:00, patient experienced sore arm. On 12Mar2021, the patient experienced moderate headache which lasted for 15 hours and on 13Mar2021, the patient felt hungover. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was reported that the patient did not receive any treatment for the event. The clinical outcome of sore arm, moderate headache and felt hungover was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
60 2021-06-30 tingling, numbness Numb tingly fingers is the worst; Tingly fingers; Upper body joint ache in neck, shoulder, elbow, wr... Read more
Numb tingly fingers is the worst; Tingly fingers; Upper body joint ache in neck, shoulder, elbow, wrist, hands; Infrequent headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration in the left arm, on 19Mar2021 at 15:30 (at the age of 60-years-old) for COVID-19 immunisation. Medical history includes Barretts esophagus and crab allergy (seafood allergy). The patient did not receive any other medications within two 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 had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 17:00 patient experienced numb tingly fingers, upper body joints ache, neck, shoulders, elbows, wrists & hands, infrequent headaches. The patient described numb tingly fingers as worst. Therapeutic measures and treatment were not received as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of numbness in fingers and tingling (in fingers), joints ache and headache were not resolved. No follow-up attempts are needed. No further information is expected.
60 2021-07-01 weakness Shortness of breath; Chest pain; rapid respiration; weakness; increased heart rate; This is a sponta... Read more
Shortness of breath; Chest pain; rapid respiration; weakness; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:00 (at age of 60 years old) as single dose for COVID-19 immunization. Medical history included Kidney stone. 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 has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient had Chest pain, shortness of breath, rapid respiration, weakness, increased heart rate on 12Mar2021 12:00PM. The adverse event result in: Emergency room/department or urgent care. No treatment received. The outcome of the events was unknown. This case Serious reported as No.
60 2021-07-02 burning sensation, hypersensitivity of all senses, numbness Numbness, burning and pain sensitiveness in palms and fingers; Numbness, burning and painsenstivenes... Read more
Numbness, burning and pain sensitiveness in palms and fingers; Numbness, burning and painsenstiveness in palms and fingers; Numbness, burning and pain senstiveness in palms and fingers; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 04Mar2021 at 18:00 (at the age of 60-years-old), as a single dose for Covid-19 immunisation. Medical history included blood pressure and psoriasis. The patient had a history of allergy to sulpha drugs. 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 15Mar2021, the patient had experienced numbness, burning and pain sensitiveness in palms and fingers. The patient received Neurontin as a part of treatment for the reported events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events numbness, burning and pain sensitiveness in palms and fingers was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
60 2021-07-02 pain in extremity On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 d... Read more
On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 26Mar2021 14:15 (at the age of 60-year-old) as dose 2, single for covid-19 immunisation. The patient previously took BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, on 05Mar2021 (at the age of 60-year-old) as dose 1, single for covid-19 immunisation and experienced sore arm. The patient medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported; ezetimibe taken for an unspecified indication, start and stop date were not reported. The patient had no allergies to medications, food, or other products. 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 26Mar2021, the patient experienced fever, headache, body aches, dizziness, sore arm. No treatment was taken for the events. The outcome of the events were recovering. No follow-up attempts are needed. No further information is expected.
60 2021-07-06 numbness, tingling Seen in the Emergency room on 4/29/21 for chest pain and nausea, vomiting, numbness and tingling in ... Read more
Seen in the Emergency room on 4/29/21 for chest pain and nausea, vomiting, numbness and tingling in feet and hands. Various tests were performed to rule out a heart attack. We were told they felt the symptoms were due to side effects of the COVID-19 vaccination. Told we could go home, if symptoms worsened or persisted to check with our primary or return to the ER if needed. We returned home, symptoms did worsen, returned to the ER on 4/30/21. PT was admitted to the hospital and eventually diagnosed with Guillain-Barre Syndrome, type AIDP (acute inflammatory demyelinating polyneuropathy), elevated troponin levels, low vitamin B12, and hypertension. He was hospitalized through 5/11/21 receiving IVIG treatments and then referred to an acute rehabilitation facility through 6/24/2021. Released to home and receiving in home therapy services currently.
60 2021-07-06 migraine Reoccurring cluster migraine headaches. No medical diagnosis due to history of adverse event. Head... Read more
Reoccurring cluster migraine headaches. No medical diagnosis due to history of adverse event. Headaches occur generally around the same time each day, 9:30 PM. Headaches last around 1 1/2 hours. This headache cycle lasted until 4/29/2021 (day after 2nd vaccination shot).
60 2021-07-06 pain in extremity Left arm pain at injection site; he was bite by a dog about 10 years ago on the right calf and 1 wee... Read more
Left arm pain at injection site; he was bite by a dog about 10 years ago on the right calf and 1 week after the vaccine began to feel pain in that right calf area where the dog bite occured and felt as though the bite had just happened all over again. Still occurring about 3-4 times per week for about an hour then goes away
60 2021-07-10 night sweats Patient was a previously healthy 60 year old male who developed an acute change in mental status on ... Read more
Patient was a previously healthy 60 year old male who developed an acute change in mental status on 4/9/21 after first receiving the Pfizer COVID-19 vaccine; he was ultimately diagnosed to have hemophagocytic lymphohistiocytosis, and other underlying etiologies were ruled out (malignancy, infection, autoimmune disorders) and improved only after initiation of HLH-directed treatment with etoposide and dexamethasone. He is currently in remission. Patient was initially admitted in 4/2021 for fevers, night sweats, weight loss, and worsening altered mental status. Patient symptoms reportedly started in ~ 4/2021. Per patient's wife, there is a temporal correlation between the patient receiving the COVID-19 vaccine and his symptoms worsening. He was admitted in 4/2021 for stroke-like symptoms after his 1st dose and was diagnosed with a TIA. He was cleared to receive the 2nd dose of the COVID-19 vaccine (received on 4/25/21), and he reportedly became worse after this dose as well. He underwent an extensive workup over the last 2 months to further evaluate his symptoms. He was found to have mediastinal lymphadenopathy on imaging. He had an excisional biopsy of these LNs which were ultimately reactive in nature (negative for lymphoma). There was no evidence of a lymphoma or a lymphoproliferative disorder. Patient was ultimately readmitted to hospital on 5/17/21 due to worsening symptoms. His labs were notable for anemia/thrombocytopenia. A bone marrow biopsy and aspirate to rule out suspected lymphoma was performed and his labs/bone marrow were consistent with a diagnosis of HLH. He was found to meet 6/8 criteria (splenomegaly, peripheral blood cytopenias, elevated ferritin, hemophagocytosis noted on bone marrow, fevers, and elevated Soluble IL-2). The hope was to do a PET/CT and LP before starting therapy to rule out secondary causes of HLH. However, his clinical status continued to deteriorate before these tests could be performed and so he was ultimately started on Dexamethasone and Etoposide as per HLH protocol. These therapies were started on June 3rd. His mental status significantly improved once the medications were started. A PET/CT and LP on 6/7/21 were finally obtained ; however, both did not show overt evidence of an underlying trigger for HLH. "Prominent mediastinal, hilar, and RP LNs seen on previous imaging were not FDG-avid." It did show a few small, mildly FDG-avid patchy B/L pulmonary opacities which were likely infectious or inflammatory for which a follow-up CT Chest was recommended. The flow from the CSF was grossly unremarkable. CSF PCR and other viral studies were negative. Of note, it is uncertain at this juncture if these tests are negative because they are truly negative, or if they are possibly falsely negative since patient was started on treatment before they were obtained. Currently, patient's mental status has significantly improved with Dexamethasone and Etoposide. Per the HLH protocol (which is a scheduled over 8 weeks), patient was started on Dexamethasone 10mg/m2 (equates to 20mg daily) and Etoposide 150mg/m2 biweekly for the 1st 2 weeks. Pt received his 2 weeks of biweekly Etoposide while inpatient (6/3, 6/9, 6/11, and 6/15). The remaining Etoposide doses are to be given weekly and his next dose would be ideally due on 6/22/21 (today). He also completed his 14-day course of Dexamethasone 10mg/m2 on day of discharge (6/16/21). Pt was advised to reduce his Dexamethasone to 5mg/m2 (or 10mg daily) on 6/17. Of note, ID was contacted on day of discharge who recommends that patient be placed on PCP PPx while on HLH therapy. He was recommended to start Mepron on 6/17/21.
60 2021-07-10 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male ... Read more
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Ep7533) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 60-years-old) at 14:45 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 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 Mar2021, the patient had experienced sore arm. The clinical outcome of the event sore arm was unknown at the time of the report. No follow-up attempts are needed. No further information is expected.
60 2021-07-11 seizure R56.9 - Seizure (CMS/HCC) E87.1 - Hyponatremia
60 2021-07-12 numbness Numbness in upper extremities and hands. Numbness and lack of power in hands and arms. Numbness and ... Read more
Numbness in upper extremities and hands. Numbness and lack of power in hands and arms. Numbness and lack of power in legs oh my God I'm ready to get you medical testing laboratory results related to the
60 2021-07-12 muscle twitching Twitching face; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old... Read more
Twitching face; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6199) via an unspecified route of administration in shoulder on 13Mar2021, (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was not had any allergies to medications, food and other products. Concomitant medications were not reported. Prior to vaccination, the patient did not diagnose 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 14Mar2021, the patient experienced twitching on left side of the face. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the event twitching face was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
60 2021-07-12 pain in extremity, discomfort headache/severe headache; sweating among other side effects/breakdown in sweat; arm still hurts/pain... Read more
headache/severe headache; sweating among other side effects/breakdown in sweat; arm still hurts/pain to arm where he received the shot; Lethargic; issues with his vision; sensitivity to light; absolutely miserable; light headed; chills; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a 60-year-old male patient (reporter's husband) via medical information team. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0165), via intramuscular route of administration, administered in left arm (left upper arm) on 22Apr2021 at 10:30 (at the age of 60-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included propranolol hydrochloride taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733), via intramuscular rout of administration in the left arm (left upper arm) on 01Apr2021 at 10:30 (at the age of 60-year-old) as dose 1, single for COVID-19 immunisation. No other prior vaccination was administrated. The patient got his 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE on 22Apr2021 and experienced headache, sweating among other side effects until "today", almost 2 months after getting his 2nd dose. The reporter would like to know if it was normal to still experience the above-mentioned side effects for this amount of time. The reporter stated that it was okay, so her husband had the Pfizer vaccine his second dose was two months ago, and he has been having adverse "I" think almost immediately afterwards he got severe headache. He was lightheaded, breakdown in sweat his arm still hurts after two months. He was lethargic, issues with his vision. He was just wiped-out walking across just across the room. He breaks out a sweat and has got a whole bunch of symptoms. "They" are very similar to COVID symptoms, but they gave him a COVID test, and he does not have COVID. "We" had gone to his regular doctor two or three times. They did not know what was wrong with him and how to fix anything. "They" did not know what kind of doctor to send him to they did a blood test, and nothing was out of line. "They" did a COVID test send it for stress test. He was absolutely miserable, severe headache "you" know sensitivity to light; all kinds of things and "we" need to do something. The reporter like to report it and hoping "you" can connect "me" with somebody who has some knowledge about whether anybody else in the world was having similar symptoms after two months and what can be done, what kind of doctor we go to. The reporter stated, "Okay so the first one I have a LOT Number, I don't have an expiration number. The LOT number was ER8733 the second one was EW0165." The reporter stated, "It was his left upper arm and was a shot. I did not know, i think It was in the muscle was not that what they are yes." Reporter stated, "That was also 10:30 in the morning." The reporter stated, Well, yes, the pacemaker, there was only one thing he not taking really. Okay, so he does not want to take medications the only thing he takes was Propranolol Hydrochloride looks like it was 60 mg once a day. He had a blood test couple weeks ago and everything was normal and had a stress test on "Monday" and "I" did not have the results from it yet. He was still experiencing the symptoms that "we" are calling about yes. That's why reporter was called. Events was persistent and has tried taking Aspirin or Tylenol and he was tried some Benadryl, and nothing has relieved his symptoms. The reporter has been complaining of chills, pain to arm where he received the shot, headaches which came on even if he was having a conversation. The patient underwent lab tests and procedures which included blood test: nothing's out of line on an unknown date in 2021, stress test: don't have the results on an unknown date in 21Jun2021, COVID test: he doesn't have covid (negative) on an unknown date in 2021. Therapeutic measures were taken as a result of headache/severe headache. The outcome of headache/severe headache, sweating among other side effects/breakdown in sweat, arm still hurts/pain to arm where he received the shot, lethargic, issues with his vision, sensitivity to light, absolutely miserable, light headed was reported as not resolved; chills was unknown. Information on Lot/Batch number was available. Additional information has been requested.
60 2021-07-14 tingling, numbness Extreme onset of arthritis in both hands, numb fingers in both hands with pins/needles with high deg... Read more
Extreme onset of arthritis in both hands, numb fingers in both hands with pins/needles with high degree of pain occurring one week after 2nd injection.
60 2021-07-14 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-Severe, Additional Details: patient briefly lost consciousness and came too once we were able to lie him down and elevate his feet. Ambulance was called and they took him for further evaluation. per patient the next morning they observed for and hour and a half and he was released. was fine the next day
60 2021-07-18 tremor Initially, the event consisted of a fever on and off for 5 days reaching 103 at one point. Took Ty... Read more
Initially, the event consisted of a fever on and off for 5 days reaching 103 at one point. Took Tylenol. Covid test on 4/15 resulted positive; Covid test on 4/18 resulted negative. Sporadic fever resumed 1st week of May on and off for a few days; visited doctor. 2nd Covid vaccine administered on 5/13 at same location (Pfizer EW0165). Since then I've experienced sporadic fevers lasting 1-3 days at a time each 2-3 weeks. Fevers are usually between 99 and 102. Most recently (7/14), experienced violent trembling with 102 fever. Visited doctor on 7/16 where bloodwork, urinalysis and chest x-rays were taken for "fever of unknown origin". Results not in yet.
60 2021-07-21 bell's palsy Patient developed Bell's Palsy, about 2 days after getting his pfizer vaccine. Patient also develope... Read more
Patient developed Bell's Palsy, about 2 days after getting his pfizer vaccine. Patient also developed hookworms. Patient has visited several doctors, and had prescriptions for hookworms. Patient is still having pain from rashes, and he state that his sturnum had popped out and the rashes have affected his groins.
60 2021-07-21 facial paralysis, numbness, burning sensation, trigeminal neuralgia 3 days later after receiving the vaccine, I started to feel a light facial numbness. I indurated for... Read more
3 days later after receiving the vaccine, I started to feel a light facial numbness. I indurated for the next 3 or 4 days. On the 23rd of April, I was taken to the ER. The ER thought I was having a stroke. They did a lot of procedures. They determined there was not nerve or brain damage as to why I had facial numbness. All of the test I had proved nothing. They could not find anything. The facial palsy persisted. It has been identified as trigeminal neuralgia. I have been given many medications to deal with this facial numbness. I was given carbamazepine for facial numbness and then switched to pregabalin for trigeminal neuralgia. Sometimes its a pain and burning sensation down my cheek, underneath my cheek, and towards the nose. Sometimes above the eyebrow, my eyelid would twitch. The numbness is getting stronger, and it gets worse each week than the previous week before.
60 2021-07-22 burning sensation Woke up small area of inflamation burning on right index finger. Seems to have developed into a sm... Read more
Woke up small area of inflamation burning on right index finger. Seems to have developed into a small area of shingles. I had chicken pox as a small child. Affected area has calmed down and skin is peeling mildly and I seem to be recovering.
60 2021-07-25 hot flush, migraine, feeling hot Constant headache since the nite after the vaccine. Some headaches are really bad, almost migrane ... Read more
Constant headache since the nite after the vaccine. Some headaches are really bad, almost migrane level occurring on right side of temple. After a month, headaches are not as bad, still persistent. Dizziness to the point that i have gotten nausea 5 out of 5 times being a passenger in a car, 2 of those times vomiting. Driving a car is fine with no dizziness or car sickness. 2 intense bouts of vertigo, starting 1 week after the vaccine Could hardly walk, bumping into things, like i got off a spinning carnival ride drunk. I took zanax and went to bed, and woke up fine. Overheating, hot flashes, and fatigue also come and go.
60 2021-07-27 pain in extremity Pain started at the left shoulder and kept like traveling through the elbow to the side left to litt... Read more
Pain started at the left shoulder and kept like traveling through the elbow to the side left to little finger and pounding of heart
60 2021-07-28 weakness Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 4... Read more
Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 4/30/21). Patient presented to ED on 7/25 c/o rash on his back, feeling generalized fatigue and weakness for last few days and had tested positive for SARS-CoV-2. Patient remained stable and was discharged from ED on same day. On 7/29 patient returned c/o headache and SOB, he was placed on 3.5L NC and given albuterol neb, acetaminophen and prednisone.
60 2021-07-28 pain in extremity initial reactions for 5 days: sore arm, tiredness, fuzzy brain, fever, gastric distress. All of th... Read more
initial reactions for 5 days: sore arm, tiredness, fuzzy brain, fever, gastric distress. All of these would fluctuate in intensity and sometimes weren't noticeable at all, except the sore arm which started strong and gradually lessened and disappeared after 3 days. The real adverse reaction I've experienced and has actually been getting worse is a racing heart. It may have actually started in May but I simply thought I had gotten out shape. I really noticed it going uphill. But starting in July, especially the last two weeks, the racing from just a brisk walk on flat land. I have to stop and rest when I haven't really exerted myself. There's no rational explanation where this has suddenly come from, until I just googled and found that it's been a reaction for some to the vaccine.
60 2021-07-29 migraine right eye lost vision; visual disturbance; migraine headache; He saw little pyramids connected toget... Read more
right eye lost vision; visual disturbance; migraine headache; He saw little pyramids connected together, then it had a thing with a pyramid shaped head at the edge of it. Stacked on top, was like a snake looking thing.; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: FA6780) via an unspecified route of administration in right arm on 09Jul2021 at 12:30 (age at vaccination 60-years-old) as first dose, single for COVID-19 immunization. Medical history included atopic allergies. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC) one pill, once a day for atopic allergies (It was working perfect. Patient had been taking for about two years). Prior vaccinations (within 4 weeks) were reported as none. On 15Jul2021, around 00:15 to 00:30, patient started to get a migraine headache. He normally did not get migraines or headaches. His head was still hurting on the right side. The pain started on the right back side of his neck. Then it moved to the cortex of his brain, just on the right side. It spilled into the right side of his brain. After he saw things, then his head was hurting so bad. He could feel the right side of his brain. It got terrible to the point that his right eye lost vision. His vision did not go black, it went white. The weird thing was that he could see two to three feet in front of him. He saw little pyramids connected together, then it had a thing with a pyramid shaped head at the edge of it. He really could see nothing, but it was clear at the same time, and he could still see the light. At first, it got whiter, and then it got black and white. Stacked on top, was like a snake looking thing. It was circling, and then moving back and forth, and then turned into an S. It straightened up and turned its head towards him. Then it started fading away. He had to leave his job because his head was hurting. He felt it on the right side of his brain. He was driving home, and it started happening again. He held his right hand over his right eye, and he could still see it. He knew that it was not an illusion, it was in his head. He was like what the hell was going on. When he got home he drank water and laid down and feel asleep when woke up can still feel pressure in head and the pressure /pain had gone away but if moved head can still feel a little bit in the right side of his brain, feel like it was still there a little. Also stated that he did have topical allergies and they do "explode" from time to time and patient was Zyrtec for that and it had been working and he did have an allergy attack about 3-4 weeks ago with sneezing. He wanted to know if that had something to do with the COVD vaccine. He vividly knew what he saw. The patient did not visit emergency room or physician office. Relevant tests were reported as none. The outcome of the events he saw little pyramids connected together, then it had a thing with a pyramid shaped head at the edge of it. Stacked on top, was like a snake looking thing was recovered on 15Jul2021, migraine headache was not recovered and right eye lost vision, visual disturbance it was unknown. Follow-up (20Jul2021): Follow-up attempts are completed. No further information is expected.
61 2021-01-03 discomfort, pain in extremity I felt light headed, sore arm, head ache and fever at first and that evening. Then woke up the next ... Read more
I felt light headed, sore arm, head ache and fever at first and that evening. Then woke up the next morning I felt fine but had swelling to the face more swelling to the left side then the right with a heavy feeling to my left side of my face along with pain to the eye. I feel very lethargic and very tired I could not go to work. I feel to bad to work.
61 2021-01-03 numbness, pain in extremity, tingling Right side of face tingly, slightly numb. Tingly feeling was gone the next day. Slightly numb feel... Read more
Right side of face tingly, slightly numb. Tingly feeling was gone the next day. Slightly numb feeling lasted at least three or four days. Right arm was sore for four days. Until 12/28, pain in upper right arm would start for no reason, usually in the evening.
61 2021-01-05 mild one side paralysis, face paralysis 5 days later December 31st Noticed weakness on my left side of my face. Tearing on the left eye .... Read more
5 days later December 31st Noticed weakness on my left side of my face. Tearing on the left eye . Unable to open wide on my left lips
61 2021-01-05 night sweats Severe night sweats for 3 nights in a row. Severe fatigue for 2 weeks. No fever. No cough. No si... Read more
Severe night sweats for 3 nights in a row. Severe fatigue for 2 weeks. No fever. No cough. No sick contacts and no contacts became sick.
61 2021-01-06 flushing, tingling, cold sweat tingling from fingers thru body to toes, cold sweats, flushing, elevated BP/Pulse (170/110,130) Date... Read more
tingling from fingers thru body to toes, cold sweats, flushing, elevated BP/Pulse (170/110,130) Date of Onset: about 40 min after receiving vaccine. Patient went to ED and received Medrol, benadryl, and famotidine,
61 2021-01-06 pain in extremity "Pain like a torn rotator cuff, i couldn't lift my arm. After about 2 weeks i was back to 80% mobil... Read more
"Pain like a torn rotator cuff, i couldn't lift my arm. After about 2 weeks i was back to 80% mobility. on 1/7/21 i am almost back to 100%. No other symptoms"
61 2021-01-10 feeling cold Got dizzy after vaccine and was told to sit down for 15 min after 15 I still felt dizzy so I stayed ... Read more
Got dizzy after vaccine and was told to sit down for 15 min after 15 I still felt dizzy so I stayed seated for an extra 10 min, still felt not ok but enough to go. Went home and still felt dizzy and then I felt like I need to pee but I was very cold , urinated 3 more times thinking it was because it was due to being cold but doctor explained it was due to me drinking lost of water. Went to bathroom and bassed out and woke up about an hour later, but during the fall I injured the neck by heating your head on the sink, back and broke my nose, when I woke up I was still very dizzy. Also felt a fast heart rate, chest pain, very nauseas and started sweating a lot.
61 2021-01-10 tingling, pain in extremity Per the patient's description, about 36 hours after the first dose he began having pain and tingling... Read more
Per the patient's description, about 36 hours after the first dose he began having pain and tingling sensation and feeling of swelling in both feet and less in both hands. He had difficulty walking for about 2 days. No fever or anything else. After the second dose given on January 5, 2021, Lot number EL1284, he had a milder reaction that lasted for one day and started 2 days after the shot.
61 2021-01-11 weakness High fever; Vomiting; Severe fatigue; Weakness; This is a spontaneous report from a contactable phys... Read more
High fever; Vomiting; Severe fatigue; Weakness; This is a spontaneous report from a contactable physician (patient himself). This 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1442), via intramuscular, on 05Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 61-year-old. Vaccine location was deltoid left. The subject did not have a relevant medical history and concomitant medications. On 06Jan2021, the patient developed high fever, vomiting, severe fatigue and weakness. He did not experience anaphylaxis. The events were considered serious as medically significant. The patient stated that side effects mentioned lasted 3 hours and he felt much better now. However, the final clinical outcome was unknown. The patient is not sure if he should get the shot again in 3 weeks since he was really sick. The reporting physician considered the events 'high fever', 'vomiting', 'severe fatigue' and 'weakness' related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, vomiting, fatigue and asthenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
61 2021-01-11 face paralysis, bell's palsy Right sided facial weakness, right eye tearing, Bell's Palsy diagnosis
61 2021-01-11 numbness Left arm numbness and chest pain. saw doctor on site. no other details regarding treatment.
61 2021-01-11 pain in extremity Awakened 0300 the next day, Saturday the 9th with chills, fever 2 degrees above normal, headache an... Read more
Awakened 0300 the next day, Saturday the 9th with chills, fever 2 degrees above normal, headache and left arm pain from deltoid to elbow. Went to work in ICU at 0638, feeling like i had been ran over by a truck. Fatigue and general malaise throughout day. Sunday, i had no problems. Monday morning awakened with diarrhea, I never have diarrhea! I felt bad most of Monday. Tuesday today, i feel fine!
61 2021-01-12 face paralysis, facial paralysis left side will blur; Left side of face was sagging/ water leaking out of mouth/Progressive weakness ... Read more
left side will blur; Left side of face was sagging/ water leaking out of mouth/Progressive weakness on left side of face/ Swelling on lower left mandible/ diagnosed with Bell's Palsy.; Eye tearing; This is a spontaneous report from a contactable nurse who reported for himself. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK5780) in left arm on 26Dec2020 at 08:30 at single dose for covid-19 immunisation (worked in surgical ICU and was over 61 years old). Medical history included Pre-diabetic. Family history included: mother died; mother's side had colon cancer and grandparents and uncles had cardiovascular diseases.Concomitant medication included exenatide (BYDUREON), amlodipine besilate (NORVASC), omeprazole (PROTONIX), hydrochlorothiazide, lisinopril and pneumococcal vaccine on 08Dec2020 and tetanus vaccine on 08Dec2020. It was reported that on 31Dec2020 at 07:30, the patient had eye tearing and water leaking out of mouth, left side of face was sagging, swelling on lower left mandible (eye tearing was first, as reported); on 31Dec2020 he also experienced progressive weakness on left side of face; on 02Jan2021 the patient was diagnosed with Bell's Palsy. Then on an unknown date, left side will blur occurred. All events required emergency room visit and physician office visit. Diagnosis of Bell's Palsy and event eye tearing were serious per disability; left side will blur was non serious. Patient described the events as follows: on 31Dec2020 he was brushing teeth and noticed the water was going everywhere. Left side of face was sagging, noticed some swelling and thought it was from a bug bite. He wasn't sure if it was a stroke or not. In the morning of 01Jan2021 noticed it was progressively causing a problem. Days before noticed tearing of left eye (as reported). On 31Dec2020 before midnight, something felt wrong. He saw four cases on clinical trial with similar side effects (he clarified he had no patient information for the four patients mentioned with similar side effects from Pfizer Clinical trial. He saw this information from a article; stated four from Pfizer and Moderna). In the morning of 02Jan202, he went to Emergency Room (ER) and was diagnosed with Bells Palsy. He was given prednisone 20mg to take 3 times by mouth every day for 5 days, tetracycline 100mg, at 1 capsule by mouth twice a day for 10 days and methylprednisolone (SOLU MEDROL; Lot: 9945776;Exp: Nov2021) 4mg dose pack, started with 6 tablets first day. It was told by doctor it might cause tick problems. He was waiting for results. On 04Jan2021 went to family doctor and more blood work was taken. Because he was taking prednisone, noticed his sugar was up a little bit (date unspecified). It was prescribed Glitizide extended release, 2.5mg one tablet twice a day with breakfast. Patient was checking sugar every 6 hours. It was also prescribed Acyclovir 400mg one tablet orally five times per day for 10 days. 08Jan2021 is last day of prednisone 5 day dose and will follow up with methylprednisolone tablets. Patient had an appointment with a neurologist on 13Jan2021. Patient was still having symptoms. It was really hard for him. Not hard to swallow. Face was still drooping. Eyes were still tearing. Could not work with eyes tearing all of the time. Needed to be alert. When driving, had to focus on the right side because his left side will blur. He had to chew only on the right side because food will be left behind in between his cheeks and gums. If he drank through a straw, he had to cover the left side of his lips so he was able to suck out fluids. He thought symptoms were progressively getting worse, he didn't see much improvement. He clarified swelling was on lower part of mandible on left side. It was slightly bigger than right. When looking at face, the lines on his forehead on the left side were down. If he smiled he cannot raise his left eye brow, when before the COVID-19 vaccine he could. Noticed left side of nose was lower than the right. Cannot raise left side of lips. Outcome of the event Eyes tearing and Bell's Palsy was not recovered; outcome of the other event was unknown. Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Bell's palsy, Lacrimation increased and vision blurred due to temporal relationship. However, the Bell's palsy may likely possibly represent concurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and viral serologies, 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.
61 2021-01-13 weakness headache, chills, injection site pain, feeling unwell, difficulty breathing, dizziness, weakness and... Read more
headache, chills, injection site pain, feeling unwell, difficulty breathing, dizziness, weakness and imbalance
61 2021-01-13 tingling lower legs red prickly itchy rash , dryness.
61 2021-01-13 tingling L HAND DORSAL ASPECT WITH TINGLING AFTER 10 MIN. Resolved in 5 minutes.
61 2021-01-14 mild one side paralysis headache, left sided weakness, nausea and fatigue
61 2021-01-16 pain in extremity Sore arm for approximately 24 hours, headache for approximately 12 hours,muscle/ joint aches 12 hour... Read more
Sore arm for approximately 24 hours, headache for approximately 12 hours,muscle/ joint aches 12 hours. Took 2 Tylenol. All symptoms gone after 30 hours.
61 2021-01-18 facial paralysis left facial palsy
61 2021-01-20 numbness Numbness in right thigh from hip bone to knee cap. Still numb as of 1/21/2021.
61 2021-01-20 seizure, mild one side paralysis Hypoxia, left sided weakness, seizures, transferred to Emergency Room.
61 2021-01-21 facial paralysis Bell's Palsy; This is a spontaneous report from a contactable other hcp. A 61-years-old male pati... Read more
Bell's Palsy; This is a spontaneous report from a contactable other hcp. A 61-years-old male patient received bnt162b2 (BNT162B2; Lot # EH9899), intramuscular in the right arm on 17Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included lung neoplasm malignant , adenocarcinoma from an unknown date and unknown if ongoing. Concomitant medication included duloxetine (DULOXETINE), levetiracetam (LEVETIRACETAM), omeprazole (OMEPRAZOLE), olanzapine (OLANZAPINE), hydromorphone (HYDROMORPHONE) , fentanyl (FENTANYL PATCH), bisacodyl (BISACODYL). The patient experienced Bell's palsy on 02Jan2021 with outcome of recovered. The patient had to be treated in Emergency room/department or urgent care; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of Bell's palsy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-01-24 weakness RIGHT BRACHIAL PLEXOPATHY SYMPTOMS WITH WEAKNESS FINGER EXTENSORS. SYMPTOMS ARE IMPROVING. 50-60% BE... Read more
RIGHT BRACHIAL PLEXOPATHY SYMPTOMS WITH WEAKNESS FINGER EXTENSORS. SYMPTOMS ARE IMPROVING. 50-60% BETTER ALMOST A MONTH LETTER
61 2021-01-24 muscle spasms, tingling Right Brachial plexopathy. Began with right periscapular muscle spasms x 5 days followed by right ar... Read more
Right Brachial plexopathy. Began with right periscapular muscle spasms x 5 days followed by right arm paresthesias on day 6 followed by right wrist and hand weakness on day 7 of adverse event.
61 2021-01-26 pain in extremity intractable left arm pain for 6 hours, unable to move arm, started about 9 hours after injection
61 2021-01-27 unresponsive to stimuli All residents had been in isolation due to multiple cases of COVID in the facility. Resident voiced ... Read more
All residents had been in isolation due to multiple cases of COVID in the facility. Resident voiced no health related complaints. He continued to visit with staff and required moderate assist with toileting. Resident had fall 0130 on 1-15-2021, which resulted in laceration with surgical repair. Resident was noted to change in mental status and respirations on morning of 1-16-2021 during morning blood sugar check. Resident had O2 @1.5l/m via n/c and respirations of 10 with periods of apnea and unresponsive to verbal stimuli. Blood sugar was 583. Resident deceased upon re-check after calling PCP to report status change.
61 2021-01-28 muscle spasms Injection site pain, Tiredness, Headache, Muscle cramps & pain, Chills, Joint pain (extreme), Fever,... Read more
Injection site pain, Tiredness, Headache, Muscle cramps & pain, Chills, Joint pain (extreme), Fever, Feeling Unwell.
61 2021-01-28 pain in extremity Got the injection around 8:15 AM, by around 2:00 PM started to feel mildly achy and tired. Around 6:... Read more
Got the injection around 8:15 AM, by around 2:00 PM started to feel mildly achy and tired. Around 6:00 PM arm was sore, I was tired, not feeling well. Went to bed, started to get chills, nausea, and vomited around 9:30 PM. Did not sleep well. The next day I had a headache, felt tired and wiped out. Started to feel better around 2:00 PM . Lost day of work was able to return to work on 1/21/2021. My arm still ached for several days. It felt like someone had hit me in the shoulder with their fist
61 2021-01-31 feeling hot I was asked to sit down for 15 mins in the observation chair. I started to feel a warm feeling in t... Read more
I was asked to sit down for 15 mins in the observation chair. I started to feel a warm feeling in the arm went back to work.The next day arm was sore at the injection site went away that night. On Friday night started vomiting and diarrhea at the same time.After 3 days following Monday I went to ER stayed 2 wks 12 days with blockage small intestine.
61 2021-01-31 pain in extremity felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like... Read more
felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after; felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after; achy arm; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information team a Pfizer-sponsored program, Pfizer First Connect. A 61-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 12Jan2021 at a single dose for COVID-19 immunization administered at the hospital. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, batch/lot number and expiration date unknown) on 22Dec2020. Relevant medical history included high blood pressure and diabetes; both were diagnosed in 2006 and ongoing conditions and were under control. Concomitant medications included metformin, lisinopril for high blood pressure, and semaglutide (OZEMPIC, injection), which was a once a week injection kind of like "Trulicity" that encourages his body to make more insulin. The patient said that when he got the second dose of the vaccine on 12Jan2021, he got an achy arm and it went away. At the time of the report on 18Jan2021, almost a week later, he felt like he got the vaccine in his arm again and it was going into his shoulder. The patient was asking if it was normal. He was driving at the time of the call. The patient had been a scrub technician (tech) and an endoscopy tech for 20 years. During the first surge, when they shut down the outpatient surgeries, he went and worked as an aide in the COVID ward. He was glad to get the shot. He did what his kids would do when they were young and would get a shot. He took ibuprofen. Later that evening for the achy arm, he took more ibuprofen. The achy arm lasted only a day. He thought he wasn't going to have any side effects at all. It felt like a flu shot. The patient clarified that at the time of the report (18Jan2021), his arm felt achy like it was the day he got the shot and the day after. He got the vaccine as he was in the first bunch in the city and he works in healthcare and the fact that he was over 60 years old. The patient stated he could live through it and he was just curious. The reporter assessed the events as non-serious. The events did not require any visit to an emergency room or a physician office. The patient had no relevant tests. Therapeutic measures were taken as a result of achy arm, which included ibuprofen. The patient recovered from the event "achy arm" on 13Jan2021, while the outcome of the event "felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after" was unknown. Information on the batch/lot number has been requested.
61 2021-02-01 numbness tingling on outside of left arm where he had the shot that progresses to his pinky finger which is m... Read more
tingling on outside of left arm where he had the shot that progresses to his pinky finger which is most numb; tingling on outside of left arm where he had the shot that progresses to his pinky finger which is most numb; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ELQ142), via an unspecified route of administration on 12Jan2021 at single dose at left arm for covid-19 immunisation. Medical history and concomitant medications were none. Patient experienced tingling outside of left arm where he had the shot, progresses to pinky finger which was most numb. Stated thumb and pinky finger that it was not there. Stated when woke up had numbness tingling feeling that had never gone away. Above symptoms started on 16Jan2021. No treatment was received for the events. Outcome of the events was not resolved. The second dose was due on 02Feb2021.
61 2021-02-01 pain in extremity This is spontaneous report from a contactable consumer (patient). A 61-year-old male patient receive... Read more
This is spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included Blood pressure high, Cancer (Two or less years ago; In remission, Taking medication to follow through with remission period), Allergies and sinus issues, covid virus (in July). The patient reported soreness in the arm (15Jan2021), fatigue (15Jan2021) and palpitations (16Jan2021) that he felt below the mouth and above the heart, calling it the esophagus area. He wanted to know if others had reported this same palpitation. The reporter further reported that he has a little bit of concern. He felt fine, had sore arm and fatigue that has gone away. Noticed lately, somewhere in his esophagus between his heart and mouth that he is feeling palpitations. Doesn't know if it's more indigestion. Stated it could be gas. Sometimes comes and goes, feels different than what he's already experienced. Wanted to double check if this has been heard of or anything similar to it. Clarified product as first dose of COVID-19 Vaccine. Received last Thursday. Received COVID-19 Vaccine in left arm on 14Jan2021 between 15:00 and 16:00. Both arms are sore, but only because other arm is injured. Pain level in injection arm was around 5-6 and he wasn't able to sleep on that side. Within the second day, 16Jan2021 in late afternoon soreness and fatigue was gone. Indigestion or Palpitations, feeling was happening again. They wanted to know if that is something he is experiencing from the COVID-19 Vaccine. Stated it doesn't appear to be related. It is around the esophagus. Stated it affects breathing. Stated maybe that has something to do with it. For the dose, they noticed it was a small amount of fluid in the tube that was injected into him. The outcome of the events soreness in the arm/sore arm and fatigue was recovered on 16Jan2021, while for other events was unknown. Information on the batch number/lot number has been requested.
61 2021-02-06 weakness, unresponsive to stimuli, seizure anxious, restless, weak, dizzy, felt "horrible". Continued to C/O symptoms,. At 01:15, patient lost ... Read more
anxious, restless, weak, dizzy, felt "horrible". Continued to C/O symptoms,. At 01:15, patient lost consciousness , then stopped breathing and lost pulse. Narrative: Patient was first vaccinated for COVID 19 on 1/8/21. On 1/24/21: 61 year old presents to E.R. with CC of chest pain/sob, with multiple medical conditions including hypertension, atrial fibrillation on apixaban, cardiomyopathy with poor EF, dyslipidemia, COPD, CVA, lung CA s/p radiotherapy, PTSD, depression, Churg Strauss Syndrome, Sjogren's syndrome presented with chief complaint of chest pain or shortness of breath. He has been having worsening shortness of breath the past few days, also complains of cough productive of yellowish sputum, no hemoptysis. He complains of left upper chest pain with no radiation. There is no diaphoresis, palpitations or lightheadedness. He denies fever or chills. He complains of having fallen a few times recently, thus he passed out. Could not say if there were seizures activity. Admitted to 3D Tele. On 1/27, Pt advises he had episode of substernal CP this am. RN advises pt was in afib w/ RVR at a rate >140 at time of CP. Pt CP improved w/ prn NTG. Pt HR improved after daily medications. Pt sts his CP has resolved. Pt admits to continued dyspnea. Increased trop, transferred. 1/28, struggling with orthopnea and cough. He has no peripheral edema. He does have intermittent chest pain. Patient having periods of A-Fib RVR with non-sustained rates of 140's-150's 1/29 more chest pain at 04:00, relieved with NTG. HR = AF, with RVR 145. At about 08:00, Cardiology sees patient and signs off, "shortness of breath and cough not due to heart failure as evidenced by orthostatic hypotension and no improvement in symptoms with diuresis. Consider underlying lung disease vs acute pulmonary disease." No pulmonary consult noted. 1/29 Patient received 2nd dose COVID19 vaccine at about 3:30-4p. No notes from staff on this event. No notes from MD that this was discussed and still part of the plan. 1/29 nurse's note: At around 2240 Pt was able to rest briefly but is now restless and anxious again. Tachypneic, stating he feels so weak and dizzy and overall just feel horrible. Continuing to get up frequently to have small soft bowel movements with assistance. Pt also stated ever since he got "that shot" he hasn't felt well. When asked what shot pt replied "COVID shot." Pt did receive 2nd dose of COVID vaccine 1/29 at 1530. Around 2250 Spoke w MOD to relay above information and overall concern for pt, asked for MOD to come to bedside to evaluate pt. MOD states he's handing off to oncoming MOD and they will come to bedside to see pt. Around 2300 oncoming MOD called and all above and previous information discussed Around 2310 MOD came to bedside to see pt. Will continue to monitor closely. 01/30/2021 ADDENDUM Around 0115 pt called for help to use bedside commode to urinate and have BM. Assisted x2 to BSC. While sitting on BSC pt's eyes rolled back and pt made postures consistent with a seizure, body became very rigid. Pt was unresponsive still with pulse. Lifted patient back to bed with 3 staff assist. Pt stopped breathing and lost pulse. Chest compressions started immediately and Code Blue called at 0120. 1/30 Hospitalist note: Called for CODE BLUE AGAIN AT 4:53. While on Vent after s/p Code blue for reasons not clear patient went into Asystole and code called second time. Patient had a prolonged CPR and was actually called off at 5:17 but he started having pulse and agonal resp. he was placed on Levophed and D5NS. He got a total of 9 amps of epi, 3 amps od Bicarb and 1amp of D50. Trope bumped from 0.12 to 0.43 prior to this he already was on ASA, Apixiban for afib. Cards are on board for his CHF for his pulmonary edema Lasix ordered. Hid lactic acid is elevated. Blood cultures pending. Started Zosyn and is on Levophed. Continue to monitor. Updated patients Mom and she requested to do everything at this point. Coded again at 5:40, survived, but AOD writes a death note(?) Coded for the 4th time at 08:18. Family at beside, Mother asks for code to be stopped.
61 2021-02-07 muscle twitching, unresponsive to stimuli 1/31/21 0730 am confused and low grade temp 99.5, 12 noon Temp 100.6 and sitting in recliner non res... Read more
1/31/21 0730 am confused and low grade temp 99.5, 12 noon Temp 100.6 and sitting in recliner non responsive twitching. Sent to Hospital with EMS to rule out stroke. Admitted 1/31/21.
61 2021-02-08 weakness, migraine, night sweats 31 Jan 2021-Sunday-Very weak, diarrhea, migraines,-no diagnosis-pt states nights sweats 1Feb 2021-Mo... Read more
31 Jan 2021-Sunday-Very weak, diarrhea, migraines,-no diagnosis-pt states nights sweats 1Feb 2021-Monday-Same as above 2 Feb-Tuesday-feeling a little better 3 Feb-WED-more fatigued 4th Feb-TH-home from work-later that day 5th Feb-Fri-no work-at home 6th FEB-Sat-feeling up & up-has a migraine-takes aleve 7th Feb-Sun-still diarrhea-stayed in bed 8th Feb-Monday-**diarrhea-taking Immodium AD
61 2021-02-09 weakness Dizziness, muscular aches, severe headache, overall weakness
61 2021-02-09 numbness and pain in extremities Within 24hrs fever, malaise, progressive weakness beginning in the lower extremities and advancing p... Read more
Within 24hrs fever, malaise, progressive weakness beginning in the lower extremities and advancing proximally to affect arms. Severe neuropathy
61 2021-02-10 pain in extremity headache; Left arm sore; This is a spontaneous report from a contactable consumer (patient) This 61... Read more
headache; Left arm sore; This is a spontaneous report from a contactable consumer (patient) This 61-year-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL3247 at left arm on 26Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation . Facility where the most recent COVID-19 vaccine was administered:Workplace clinic. the patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.Medical history :none. Concomitant medication included atorvastatin calcium (LIPITOR ) bupropion hydrochloride (WELLBUTRIN), acetylsalicylic acid (ASPIRIN) 81 mg.The patient experienced left arm sore and minor headache on 27Jan2021 06:00 .No treatment received.Events reported as non serious.Outcome of the event was recovering.No Prior to vaccination, was the patient diagnosed with COVID-19 .Since the vaccination, The patient hadn't been tested for COVID-19
61 2021-02-11 numbness Numbness shooting up injection arm starting from two middle fingers, traveling up arm to shoulder.
61 2021-02-15 tremor Pt reports he started shaking all over on 2/6/21 and it gradually improved over the next week. He c... Read more
Pt reports he started shaking all over on 2/6/21 and it gradually improved over the next week. He continues to experience problems with short term memory and recall. Headaches, myalgias/arthralgias. Positive for mild nausea, constipation. Dizziness with turning his head started on 2/6/21 but has now resolved.
61 2021-02-17 pain in extremity This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 26Jan2021 13:15 at single dose in left arm for COVID-19 immunisation. Age at vaccination was 61 years. The vaccine was administered at Doctor's office/urgent care. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) received on 05Jan2021 at 01:30 PM at single dose in left arm and the patient experienced sore arm. Medical history included Supraventricular tachycardia (SVT), Herpes, Hyperlipidemia, idiopathic mesenteric lymphadenopathy. The patient has no known allergies to medications, food, or other products. Concomitant medications included Valacyclovir, cyclobenzaprine, Metoprolol, lipitor. The patient reported second dose 8 hours post headache, sore arm and entire upper torso pain, chills and fever 101-102F 12 hrs. Patient was lethargic the whole next day with severe headache. Normal 2nd day after. Adverse events start date was reported as 26Jan2021 16:00. No treatment was received for the events. The events were reported as non serious. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The events were resolving (as reported).
61 2021-02-19 pain in extremity Extreme exacerbation of patient's longstanding Crohns Disease. Intractable liquid diarrhea for 5 day... Read more
Extreme exacerbation of patient's longstanding Crohns Disease. Intractable liquid diarrhea for 5 days beginning approximately 48 hours after first shot; almost constant Fever; Body Aches; Strong lower back and hip pain; Bilateral pedal edema; dehydration; inability to absorb fluids for 5 days; arm, ankle, hip, back, shoulder, and wrist joint pain; difficulty getting out of bed in the morning, or getting up from the stationary position. Symptoms finally resolved day 7 just before I anticipated going to ED in local hospital, and were gone for two days. Symptoms returned on day 9 following vaccination and lasted 5 additional days, with symptoms resolving for good only on the 15th day after the initial injection.
61 2021-02-21 weakness, feeling cold Chilly Nausea weak
61 2021-02-25 bell's palsy, facial paralysis Per patient, he received his second dose of Pfizer COVID-19 vaccine on 02/20/2021. Approximately 48... Read more
Per patient, he received his second dose of Pfizer COVID-19 vaccine on 02/20/2021. Approximately 48 hours later, he developed left-sided lip paralysis. He went to his doctor that day, no medications were prescribed and no tests were ordered. Over the next 24 hours, he states that his symptoms progressively worsened and now the left side of his face seems "completely paralyzed." He described left ear pain, increased sensitivity to loud sounds, runny nose, and inability to close his left eye. He saw another doctor the next day, who diagnosed Bell's Palsy and prescribed valacyclovir for 7 days. Patient also noticed a transient "crooked smile" after his first dose of Pfizer vaccine, but did not relate this
61 2021-02-26 muscle spasms Acute muscle spasm middle back left of spine
61 2021-02-27 depressed level of consciousness Pain in left arm was so strong that I could not roll over to get out of of bed. All other joints and... Read more
Pain in left arm was so strong that I could not roll over to get out of of bed. All other joints and areas in which I have minor aches and pains were very sore. Mind somewhat clouded. Modest temperature, 101. Chills. Like a bad flu, but more pain and less congestion. Strong but not splitting headache. Not like a migraine--not at all as bad. Very minor nose congestion and sore throat. Symptoms all ended by 36 hours after 2nd shot
61 2021-02-28 discomfort he was not comfortable; allergic reaction; dizziness; feeling a lot of pressure in his head like his... Read more
he was not comfortable; allergic reaction; dizziness; feeling a lot of pressure in his head like his "brain wanted to pop out of his head"/ his brain wanted to swell up; felt like he was going to lose his mind / go crazy; fever; headache is recurring- worse at bedtime; almost passed out; This is a spontaneous report from a contactable consumer reporting for himself. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9621), intramuscular on the left arm on 22Jan2021 (reported as 07:45 to 08:00) at a SINGLE DOSE for prevent COVID, at 61 years old. Medical history included triple bypass surgery from an unknown date. There were no concomitant medications. The patient previously took morphine and experienced the same thing with his brain, almost identical to what he was experiencing after the COVID vaccine. He reported that the first time he received morphine it was fine and then he got a shot of morphine and he experienced the pressure on his brain after receiving morphine, about 5 or 6 years before reporting time. He stated it was almost the same reaction. He was given a shot of Demerol (he was not sure if it was Demerol) to counteract it. History of all previous immunization reported as none. No additional vaccines administered on the same date. No prior vaccinations within 4 weeks. The patient reported he experienced an "allergic reaction"/ bad reaction to his first dose of BNT162B2 on 22Jan2021. His symptoms included dizziness as soon as he got the vaccine, got dizzy right off the bat, still dizzy, very little; feeling a lot of pressure in his head like his "brain wanted to pop out of his head"/ his brain wanted to swell up; felt like he was going to lose his mind / go crazy; fever; headache is recurring- worse at bedtime. Symptoms (unspecified which) reported as recurring and are notably worse at bedtime. Patient is hesitant to receive the second dose. The patient stated he just went to sleep and prayed and then when he woke the next day, at night it did it again. At night it comes and goes, and he still has it happen but not like the first time. He tried to describe that he was washing his hands and he almost passed out like on an unspecified date in Jan2021, he was going to lose his mind. Last night he went to bed no problem, he felt a little pressure on his brain, stated it is hard to describe, it was not a good feeling. He was running a fever. Last night he had a slight fever, like it was going away. He was not able to drive when this was happening and today was the first day he could drive and he was not comfortable (27Jan2021). The patient declined any treatment. He already talked to his doctor and was told to call Pfizer. He asked if he was to get the second shot, is there something he could to take to make that feeling go away or counteract it. No relevant tests were reported. Events did not require a visit to the emergency room nor physician office. The outcome of the events, allergic reaction, headache is recurring- worse at bedtime, almost passed out and he was not comfortable was unknown. Outcome of the events dizziness, "feeling a lot of pressure in his head like his brain wanted to pop out of his head/ his brain wanted to swell up", felt like he was going to lose his mind / go crazy, and fever was reported as recovering.
61 2021-02-28 pain in extremity Shoulder Pain starting 48+ hours after injection. Initial arm soreness went away in less than 24hou... Read more
Shoulder Pain starting 48+ hours after injection. Initial arm soreness went away in less than 24hours. At time of injection the shot was given high on my shoulder and sent pain through my back an up my neck. The shot was administered into my shoulder not my muscle This is problem from the injection not the vaccine. SIRVA type injury
61 2021-02-28 tenderness, pain in extremity After the vaccine he came home, felt a little less sore than a flu shot. The next day when he took ... Read more
After the vaccine he came home, felt a little less sore than a flu shot. The next day when he took a shower, and when he went to wash under his armpit was very swollen, and very tender. He put some ice on it which did not help the swelling. It bothers him when his T-shirt touches the area, so he tried to wear a regular shirt. He also had achy pain in his back, weakness in his arms, sore throat and a little cough, no fever. The armpit still hurts and is still swollen. Other than the ice he did not take anything else as he takes a lot of medications as it is. He has not called his doctor because it happened over the weekend, but is going to call her today. He did have a COVID test yesterday drive through facility at the community hospital as he has a surgery coming up, and they were going to call him if it was positive. He is scheduled for surgery on his right knee on Thursday.
61 2021-03-02 facial paralysis had total paralysis of the left side of his face; This is a spontaneous report from a contactable co... Read more
had total paralysis of the left side of his face; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at arm left on 20Feb2021 11:00 AM at the age of 61-year-old at single dose for COVID-19 immunisation. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at left arm on 30Jan2021 11:00 AM at the age of 61-year-old for COVID-19 immunisation. Patient had no COVID-19 prior vaccination. COVID-19 was not tested post vaccination. There was no known allergies. Other relevant medical history was reported as none. Concomitant medications were not reported. There was no other vaccine in four weeks. Patient had total paralysis of the left side of his face on 22Feb2021 at 07:00 AM. It was reported that the event resulted in disability or permanent damage. Outcome of the event was not recovered. No treatment for the event was received. Information on the lot/batch number has been requested.
61 2021-03-04 bell's palsy BELL PALSY left side of face and mouth. taking prednisone 20 mg tablet 3 each one time a day for 7 ... Read more
BELL PALSY left side of face and mouth. taking prednisone 20 mg tablet 3 each one time a day for 7 days. started 3/1/21 still have BELL PALSY left side of face and mouth as of 3/5/21.
61 2021-03-04 numbness, tingling Within two hours of injection, I began to feel numbness in my right foot. Later that day, I experien... Read more
Within two hours of injection, I began to feel numbness in my right foot. Later that day, I experienced tingling in my fingers on both hands. This has continued for several days now and has worsened today (three days after injection), with the tingling being stronger and moving into my calves. I have had no loss of strength or coordination. I had similar peripheral neuropathy about 20 to 25 years ago; no reason was ever found, and it went away. This is the first recurrence in many years, and by far the most widespread on my body and the most acute sensations.
61 2021-03-04 tingling, numbness Numbness in face and lips. Some tingling. Rapid heartbeat. Normal breathing
61 2021-03-08 cold sweat, pain in extremity Approximately two hours after getting the shot, I felt clammy and had a fever. Very fatigued, left ... Read more
Approximately two hours after getting the shot, I felt clammy and had a fever. Very fatigued, left arm very sore. In bed by 7 p.m.. Slept till 7 a.m. Friday(3-5). Chills and fever subsided that morning. Headache and ringing in my ears. This and extreme fatigue lasted until Sunday(3-7). Unable to work for 2.5 days. Lost income. Went back to work Sunday morning, but not completely recovered. Felt back to normal by Monday morning .
61 2021-03-08 unresponsive to stimuli Patient had a syncopal episode
61 2021-03-10 weakness Nausea, throat tightness, dizziness, weakness, evaluated by EMS-refused transport to nearest ER
61 2021-03-11 muscle spasms Headache, sore arm at injection, leg cramps - evening of injection >>> Blood pressure spike to 150/... Read more
Headache, sore arm at injection, leg cramps - evening of injection >>> Blood pressure spike to 150/100 on second evening after injection, felt funny, bad sleep <<<
61 2021-03-11 tingling, tremor Warm red skin of face arms hands feet. Swelling in feet and hands. Trouble sleeping, anxiety, shaky.... Read more
Warm red skin of face arms hands feet. Swelling in feet and hands. Trouble sleeping, anxiety, shaky. Prickly feeling throughout body.
61 2021-03-12 hot flush patient was given 1st injection and about 5 minutes afterward @ 1205 he started to fell like a warm... Read more
patient was given 1st injection and about 5 minutes afterward @ 1205 he started to fell like a warm flushing feeling, and feeling a little fuzzy in the head, heart rate 64bpm, patient blood pressure on the monitor did not appear to be accurate indicating 180/118 and this was also tried on the right wrist. Patient did not have any complaints with the elevated with this blood pressure, patient was conversing and without headache, patient denied any itching or signs of anaphylaxis. patient was monitored for a total of 55 minutes before being released. Patient was instructed to call 911 with signs of anaphylactic reaction and to call his provider with any other symtpoms that he was concerned with.
61 2021-03-15 weakness significant swelling and redness at the injection site with minimal pain; significant swelling and r... Read more
significant swelling and redness at the injection site with minimal pain; significant swelling and redness at the injection site with minimal pain; significant swelling and redness at the injection site with minimal pain; weakness; Nausea; mild myalgia; general muscle pain and aches; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: not reported), via an unspecified route of administration, on 28Jan2021 09:00 AM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was not administered at a military facility. He did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. The patient had no relevant medical history and concomitant medications to report.The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: not reported, NDC number: 59267-1000-1), on 09Jan2021 09:30 AM on the left arm for COVID-19 immunization, at the age of 61-year-old. He experienced myalgia at the injection site/pain at inject site after the first dose on 09Jan2021 and resolved on 12Jan2021. The first and second doses of bnt162b2 had the same lot number. On 28Jan2021, the patient received the second dose of bnt162b2. 24 hours later, on 29Jan2021, he experienced mild aches/pain, nausea/malaise. Three days (42-72hours) after 2nd dose, on 31Jan2021, he experienced "significant redness" and swelling at injection site with minimal pain. He described it as "Out of proportion to what should be expected". The redness and swelling were improving at the time of the report (01Feb2021). He asked if this should be of concern. He also asked if it was possible that the vaccine was given subcutaneously instead of intramuscularly. He developed a good amount of swelling and redness at the injection site. It seemed fine the first day. It took two or more days to develop the swelling. He added that he only had mild myalgia, weakness, and nausea initially on 29Jan2021 after the second dose of the vaccine. Then 48 hours later, he got the large amount of swelling and redness at the injection site. He later clarified he received the first dose of the Pfizer COVID 19 vaccine on 9Jan2021 at 09:30 AM in the left arm. He had some myalgia at the injection site on 09Jan2021 that went away on 12Jan2021. Then he received the second dose of the Pfizer COVID 19 vaccine on 28Jan2021 at 09:00 AM in the left arm. Initially he had no pain. 24 hours later, on 29Jan2021, he had myalgia referring to general muscle pain and aches and nausea that only lasted about two hours. He is mostly concerned now about the significant swelling and redness at the injection site with minimal pain which he noticed 48 to 72 hours after the second dose of the vaccine. He took some Aleve which gave some relief (for significant swelling and redness at the injection site with minimal pain). He asked if this is an expected side effect as it seem out of proportion to him. Outcome of events general muscle pain and aches and weakness was recovered on 30Jan2021. Outcome of event nausea was recovered on 29Jan2021. Outcome of events significant swelling and redness at the injection site with minimal pain was recovering. The reporting physician (patient) assessed the causality between the suspect vaccine and all events as related. He assessed the events "swelling and redness at the injection site with minimal pain" as medically significant (serious), while he assessed the other events as non-serious.; Sender's Comments: Based on temporal association and known product safety profile of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: not reported), the contributory role of the product cannot be totally excluded. The events are known adverse event of the product. 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.
61 2021-03-16 flushing, tingling Pain in head/neck, flushing, sweating, tingling of lips and feet
61 2021-03-17 bell's palsy Bells Palsy affect 60 hours after injection. Right eye.....same manifestation as I had during Covid-... Read more
Bells Palsy affect 60 hours after injection. Right eye.....same manifestation as I had during Covid-hospitalization in 2020. Seems to be abating finally (approx 18 hrs from detection). Severe headaches, chills and fatigue commenced approx 8 hours after injection. LAsted two days. On third day, headaches and fatigue continued, but mildly.
61 2021-03-17 pain in extremity Within 15 minutes of my 2nd covid shot I developed extreme lightheadedness, shortness of breath, dis... Read more
Within 15 minutes of my 2nd covid shot I developed extreme lightheadedness, shortness of breath, disorientation, dehydration and consequently extreme anxiety from the incident. I was taken to an examination room at the vaccination clinic by their nurse director. Blood pressure was high and there was a question if I was having a stroke or heart incident. the director sent me by ambulance to Hospital as they didn't know if I was having an anaphylactic shock or cardiac incident. All this occurred within an hour if the first symptoms.
61 2021-03-18 feeling cold, cold sweat Cold sweat at 2am Achy all over and especially upper joints Injection site sore Cannot get warm Sl... Read more
Cold sweat at 2am Achy all over and especially upper joints Injection site sore Cannot get warm Slight intestinal discomfort
61 2021-03-18 pain in extremity Gout in my left foot at the base of the big toe has flared up. Some swelling and redness in the are... Read more
Gout in my left foot at the base of the big toe has flared up. Some swelling and redness in the area, was warm to the touch when it started. Significant pain and lack of flexibility in the joint. Has persisted for four days.
61 2021-03-19 numbness Nausea feeling, serious backpain. Numbness along the right arm and hand.
61 2021-03-21 migraine migraine head ache, back ache, fever, nausea, lack of apatite , brain fog,, i had covid in november,... Read more
migraine head ache, back ache, fever, nausea, lack of apatite , brain fog,, i had covid in november, felt about the same, was very sick for 5 days, felling much better 8 days after the vaccine, very afraid to get the second dose, if reaction is more severe as reported in the second dose, i'm afraid i won't servive
61 2021-03-21 tingling, burning sensation Started 03/18 Headaches - stabbing/ache/pressure/burning/tingling Started 03/14 Tired Started 03/14 ... Read more
Started 03/18 Headaches - stabbing/ache/pressure/burning/tingling Started 03/14 Tired Started 03/14 Dizzy Started 03/14 High Blood pressure Started 03/14 Slight nausea
61 2021-03-22 tremor, grand mal seizure Developed fever to 104 degrees on the morning after vaccination and had a grand mal seizure that las... Read more
Developed fever to 104 degrees on the morning after vaccination and had a grand mal seizure that lasted about 1 minute followed by generalized tremors that lasted about 10-15 minutes and resolved with administration of rectal Diastat 5mg. Tremors resolved within 5 minutes. Temp treated with Ibuprofen 600mg and cool sponge bath. Temp down to 101 within one hour and afebrile after 8 hours. Temp did not recur. Normal postictal mental status. Somewhat lethargic for a day or two then gradual return to baseline cognitive and physical functioning over 10 days. Wilmer has had this type of seizure with high fever in the past.
61 2021-03-23 grand mal seizure Grand mal seizure, wife found patient lying on the ground with eyes fixed and loss of urine. Wife ca... Read more
Grand mal seizure, wife found patient lying on the ground with eyes fixed and loss of urine. Wife called EMS around 2:22 and patient came to about 15 minutes later.
61 2021-03-24 numbness, weakness immediately after vaccination, patient developed arm numbness and weakness. he was monitored at vacc... Read more
immediately after vaccination, patient developed arm numbness and weakness. he was monitored at vaccine site x15-20 min and was sent home. when he arrived home about 35-40 minutes after vaccination, that sensation traveled throughout his body. he described feeling weak all over, had lightheadedness, and tingling on his lips and tongue.
61 2021-03-24 muscle twitching Within 24 hours noticed right lower facial twitching. The frequency varies between a few in an hour... Read more
Within 24 hours noticed right lower facial twitching. The frequency varies between a few in an hour to several in 5 minutes.
61 2021-03-24 pain in extremity Sore arm, chills, fever, dizziness, nausea, aching muscles, diarrhea
61 2021-03-28 weakness On going flu symptoms since the 2nd vaccination. It is going on 8 days and I still have flu symptoms... Read more
On going flu symptoms since the 2nd vaccination. It is going on 8 days and I still have flu symptoms. I feel weak, sometimes low level headache, mostly feel weak and tired. Don't feel like I have a temp. On scale of 1-10, I would say it's around 2-3. It does affect my work ability. Not overly hungry(which can be good).
61 2021-03-28 seizure like phenomena UNKNOWN VACCINATION LOCATION. ADMITTED TO CENTER THE DAY AFTER HIS 2ND SHOT FOR CONFUSION, MENTAL ST... Read more
UNKNOWN VACCINATION LOCATION. ADMITTED TO CENTER THE DAY AFTER HIS 2ND SHOT FOR CONFUSION, MENTAL STATUS CHANGES, SYNCOPE VS SEIZURE ACTIVITY, LOSS OF CONSCIOUSNESS. NEURO CONSULTED AND THOUGHT POSSIBLE ADVERSE REACTION TO COVID VACCINE #2 AS NO OTHER REASON HAS BEEN FOUND WITH LABS, IMAGING, ETC. NEURO CALLING IT A 2 HOUR FUGUE EVENT.
61 2021-03-29 pain in extremity My left after 5 hours or so got really sore and just got worse during the day. It also got me really... Read more
My left after 5 hours or so got really sore and just got worse during the day. It also got me really tired and had to go to bed early and slept for 10 hours. Got up and felt good. The soreness in my arm was almost gone. By mid day no more soreness. I did take 800 mg of Ibuprofen twice in a 24 hr period. I don't believe it did any good.
61 2021-03-30 migraine By 2nd day and for one week, had an extreme headache (unlike any migraine). Extreme flu like symptom... Read more
By 2nd day and for one week, had an extreme headache (unlike any migraine). Extreme flu like symptoms for 1 week after vaccination. Reports severe bruising on left arm from collar bone to elbow. "It was black".
61 2021-03-30 muscle spasms Patient started with pain in his lower back thought it was muscle spasm .Kept working with the pain ... Read more
Patient started with pain in his lower back thought it was muscle spasm .Kept working with the pain rash started still didn?t think anything about it March 29 he went to family doctor said it was a muscle spasm gave him muscle pills March 29 he was taken to the emergency room in excruciating pain emergency room doctor did test bloodwork CT scan urine sample came back that he has shingles he has the rash. His wife also had the same shot and she also has rash on her side no pain.Do not know if this has anything to do with the shots but wanted to report us because he never had it before he got the shot or neither did she
61 2021-03-31 pain in extremity he is not getting any sleep; he had a rash and hives all over his body; itching; he had a rash and h... Read more
he is not getting any sleep; he had a rash and hives all over his body; itching; he had a rash and hives all over his body; sore arm; This is a spontaneous report from a contactable consumer reported for self. This 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 in the morning on Arm right at single dose (Lot # EN6205) for COVID Prevention. Medical history included ongoing leukemia CML from 2013, ongoing chronic lymphocytic leukemia from 2013, prostate cancer, white blood cell count runs high anyway, PSA (prostate specific antigen) last time he had blood work done, was 5.1. Concomitant therapy was none. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 26Feb2021 in the morning, in the evening (26Feb2021), he had a rash and hives all over his body, he also experienced sore arm. He states that he had itching sooner. He also has leukemia CML, his oncologist told him to receive the vaccine. He would like to know if he should receive the second dose of the vaccine, and get ready for rashes. He broke out in hives and it was really uncomfortable, and he was not getting any sleep. He states that the hives got so bad, it looks like he has alligator skin. He states that he took Benadryl (UPC: 81131 07825, Lot number: P113775, Expiry: Oct2020, he has been using the product since the expiry date) and used Cortisone, and it helped but did not work 100%, but it helped enough he got some sleep. He stated that he felt like it is getting better, but he was taking Benadryl, and when the Benadryl wears off, it starts doing it again, but it was bad at first, like alligator skin, so he does feel like it is improving some. Outcome of the event hives was recovering. Outcome of other events was unknown.
61 2021-04-01 weakness Moderate to severe headache, chills, weakness, and sleeplessness through the night with headache lin... Read more
Moderate to severe headache, chills, weakness, and sleeplessness through the night with headache lingering through the next day.
61 2021-04-01 flushing 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: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: pt passed out for 10 seconds, blood pressure low, when he regained consciouness he vomited.Recovered in about a half hour.
61 2021-04-01 numbness, tingling On 3/18/21 was providing vaccinations for its employees I was asked if I wanted to take advantage ... Read more
On 3/18/21 was providing vaccinations for its employees I was asked if I wanted to take advantage of the extra vaccine. I did and got the 1st vaccination Pfizer EN6208. On 3/19/21 Shortly after arrival at work 08:00 I began to feel numbness/ tingling of both my feet. The numbness/tingling had moved up to my knee?s by Noon and once at home at approximately 6:00pm while at home the numbness/ tingling had moved up to my waist. The numbness/ tingling remained from the waist down. In addition my groin and rectum region also have the numbness/ tingling. When I sit down it feels like I am sitting on a gel pad, kind of squishy. On 3/22/21 had an appointment my vitals were checked a couple of physical tests were done and he recommended a full panel of blood work.
61 2021-04-01 pain in extremity Arm soreness, mild body aches and fatigue
61 2021-04-03 numbness 1:00 am on 4/1 chills and slight fever. Remainder of day on 4/1: fever, chills, exhaustion and hea... Read more
1:00 am on 4/1 chills and slight fever. Remainder of day on 4/1: fever, chills, exhaustion and headache Friday 4/2 Headache and numbness in left hand. Tired most of day Saturday 4/3: slight numbness in left hand.
61 2021-04-03 migraine Slight migraine headache, slight nausea, slight soreness on upper arm at injection site. Ibuprofen L... Read more
Slight migraine headache, slight nausea, slight soreness on upper arm at injection site. Ibuprofen Lasted 2 days
61 2021-04-04 seizure Pfizer BioNTech COVID-19 Vaccine EUA Patient experienced a seizure 9 hours after receiving his first... Read more
Pfizer BioNTech COVID-19 Vaccine EUA Patient experienced a seizure 9 hours after receiving his first dose of COVID-19 Pfizer vaccine. Patient has a history of seizures but has been well controlled with levetiracetam and has been seizure free for several years. Patient's wife called the pharmacy to report the event 6 hours later, and the pharmacist recommended the patient to follow up with primary care physician as soon as possible. Patient was evaluated by his physician and had dosage of levetiracetam increased. Patient was referred for further testing.
61 2021-04-04 seizure While sleeping had heart attack, seizure, went into cardiac arrest. No warning signs and did not ha... Read more
While sleeping had heart attack, seizure, went into cardiac arrest. No warning signs and did not have a previous heart condition. CPR was performed, shocked four times at home once in ER and placed on a ventilator. Catheterization procedure performed, full blockage of the right coronary artery received two stents. After surgery was in ICU on a ventilator for three days then went to step down unit for two days. Now being treated by cardiologist, pulmonologist, neurologist and primary care physcian.
61 2021-04-05 slurring Patient fell while on the job on Friday March 26th, slurred talking. Later slumped over in the car w... Read more
Patient fell while on the job on Friday March 26th, slurred talking. Later slumped over in the car while driving and had to be taken to the Emergency room where he later passed away. Cause of death on the death certificate per the coroner is Pulmonary Embolus. Patient was just seen my his family physician in January and was in good health no medications taken other than eye drops.
61 2021-04-06 seizure He had 2 seizures that following Monday, 08 Feb 2021 and another seizure on Friday, 12 Feb 2021.; di... Read more
He had 2 seizures that following Monday, 08 Feb 2021 and another seizure on Friday, 12 Feb 2021.; discovered he had COVID; discovered he had COVID; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) at age of 61 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose of Pfizer's COVID vaccine on 06Feb2021. He had 2 seizures that following Monday, 08Feb2021 and another seizure on Friday, 12Feb2021. He also stated he discovered he had COVID. He was at the hospital for the seizures and diagnosed with Covid. He was due for the second dose which was supposed to be given the third week. He he spoke to the nurses there and they advised him not to do anything until after 90 days or something like that. He was told by the doctor that his second dose should be delayed until 30 to 90 days and heard from Department of Health that he had up to 42 days that he'll be ok. He stated that he just spoke to themDepartment of Health. He stated that they said after 40 or 42 some odd days, and there was an extra 7 days of leeway, he could get the second dose. He stated that his 42 days was up either today (24Mar2021) or yesterday (23Mar2021). He had an opportunity this Friday (26Mar2021) to get the second shot. He had to get the shot at the same location. He was tired of this. The patient stated when should he take the second shot? Should he wait the 90 days? He stated his primary said to see a neurologist, but he didn't see them until 05May2021 and the neurologist said they couldn't say anything because he was a new patient until they see him, so they say to go to his primary care. Dates for tested positive for covid after first dose of Covid Vaccine was unspecified. The outcome of events was unknown. Information on the lot/batch number has been requested.
61 2021-04-07 tingling Parasthesia - both arms, most remarkable in hands, concentrating on lower palm and pinkie, ring and ... Read more
Parasthesia - both arms, most remarkable in hands, concentrating on lower palm and pinkie, ring and middle finger
61 2021-04-08 weakness Tiredness headache muscle pain chills joint pain fever nausea difficulty breathing swelling in the f... Read more
Tiredness headache muscle pain chills joint pain fever nausea difficulty breathing swelling in the face a fast heartbeat dizziness and weakness stomach pain
61 2021-04-08 tingling Patient was monitored for 30 minutes without complaint. Patient returned approximately 45 minutes a... Read more
Patient was monitored for 30 minutes without complaint. Patient returned approximately 45 minutes after vaccine complaining of lips and mouth tingling that transitioned to numbness. Patient received 25mg of Benadryl PO approximately 50 minutes after vaccine. 30 minutes after Benadryl patient continued to complain of lip numbness and tingling on both palms. Patient was transferred to ED for further examination/treatment.
61 2021-04-09 facial pain March 26, 2021: One week to the day after receiving my second dose of the Pfizer COVID19 vaccine, my... Read more
March 26, 2021: One week to the day after receiving my second dose of the Pfizer COVID19 vaccine, my right eye suddenly had double vision and facial pain behind the right eye and all around the right eye (forehead, right temple, around to under the right eye on the cheek). The right eye would not move correctly. March 27, 2021: I went to see Optometrist. He performed an eye exam with dilation and stated that the right eye was slow to track, and that the nerve behind the right eye was inflamed. He recommended blood work, CT scan, and an MRI. March 27, 2021 ? March 28, 2021: We went to ER at 9:00pm. After waiting six hours, I finally was able to see an ER doctor. No medical history was taken. No bloodwork was done. ER Dr performed a CT scan as Dr requested. CT scan w/o contrast showed no masses or hemorrhages. ER suggested to follow-up with Nuerology. March 29, 2021: Went to Neurologist and he examined me. He called in another Dr for a second opinion. They stated that it may be a possible cranial nerve palsy and ordered multiple MRIs. March 29, 2021: The earliest MRI appointment available was April 7, 2021. Scheduled the MRI. April 1, 2021: Had blood drawn at lab as Dr requested. April 2, 2021: Two weeks from the day of COVID19 vaccine #2, my right eyelid would not open at all and the pain was getting worse. April 5, 2021: Went to ER at 4:30am. Triage nurse sent me straight to an ER room and within minutes an ER doctor was there. Within 15 minutes after seeing the ER doctor, a Neurologist was examining me. The nuero doctor was very thorough. While waiting for the MRI, other neurologists and residents also examined me. MRI scans with and without contrast were performed. MRI images were clear ? no tumors, no aneurisms, and no stroke. They concluded that it was a micro-vascular injury to cranial nerve #3. (Similar to the Bells Palsy that I had in 2015.) They prescribed gabapentin to help calm the nerve pain. Follow-up will be with nuero-ophthalmologist.
61 2021-04-09 pain in extremity headache; teeth hurt; leg pain; chills; low grade fever; This is a spontaneous report from a contact... Read more
headache; teeth hurt; leg pain; chills; low grade fever; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Right on 03Feb2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. On 04Feb2021 at 09:00, patient experienced headache, teeth hurt, leg pain, chills and low-grade fever. Since the event onset date was presented as 04Feb2021, however, PRD was noted as 08Feb2021, query was raised to provide the awareness date of AEs. The patient responded that the symptoms started on 04Feb2021, the day after receiving the second vaccine shot. Patient reported this to the health clinic on 04Feb2021 and filled out the report when he returned to work on 08Feb2021. The date of start of event in the report is correct and the date of receipt of the most recent information is on 08Feb2021. The outcome of the event was recovered. Information on the lot/batch number has been requested.
61 2021-04-09 tremor After about 14 hours receiving my second dose, had severe chills with shaking/shivering for about a ... Read more
After about 14 hours receiving my second dose, had severe chills with shaking/shivering for about a half-hour. Then a slight fever for about 6 hours. Then body aches- muscles and joints for 6 hours. Then it went away with mild fatigue for a couple days.
61 2021-04-10 mild one side paralysis About 30 minutes after getting the vaccine his developed a headache. Shortly after that he develope... Read more
About 30 minutes after getting the vaccine his developed a headache. Shortly after that he developed left leg weakness and inability to use left leg. The next morning his symptoms somewhat improved. Friday morning, 2 days later, his left leg weakness returned. He was directed to the ER where stroke was confirmed.
61 2021-04-10 pain in extremity Arm pain morning after shot, general fatigue and achiness in joints afternoon after shot (i.e. 24 h... Read more
Arm pain morning after shot, general fatigue and achiness in joints afternoon after shot (i.e. 24 hrs after vaccine administered). Arm pain lasted a day, fatigue about 12-18 hours.
61 2021-04-10 tremor, weakness, feeling cold 4/7/2021 @ noontime: Began to have cold shakes. Approximately 15 minutes later, began to experience ... Read more
4/7/2021 @ noontime: Began to have cold shakes. Approximately 15 minutes later, began to experience slight headache and some fatigue. Within an hour, extreme shaking, fatigue and worse headache ever experienced in my life. Went to bed, covered up and tried to rest, but headache was too severe. About 6:00pm, took ibuprofen and headache began to subside, but too weak to walk without holding onto support items. Nausea left me unable to eat and drinking water was unpleasant. Fell asleep about 10pm and woke at midnight with cold shakes and did not get back to sleep. Went to work next morning and just felt somewhat fatigue and had no appetite.
61 2021-04-11 numbness, pain in extremity Bilateral arm and hand pain, numbness in fingers. Arms go completely numb when driving or holding gr... Read more
Bilateral arm and hand pain, numbness in fingers. Arms go completely numb when driving or holding grandson. Only time they are not numb is when he is standing up. It started the same time he got his COVID vaccine.
61 2021-04-12 facial paralysis, slurring Morning of 4/8 at 0615, patient was in shower, started feeling pressure on top of head, was struggli... Read more
Morning of 4/8 at 0615, patient was in shower, started feeling pressure on top of head, was struggling to use arms, trouble using legs, unable to stand well. Wife noticed slurred speech, drooping left side of face. Called 911. Was taken ED and transferred to another Hospital. Was found to be having ischemic Stroke.
61 2021-04-12 facial paralysis Bell's palsy/eyes droopy; annoying headache 3-4 days; This is a spontaneous report from a contactabl... Read more
Bell's palsy/eyes droopy; annoying headache 3-4 days; This is a spontaneous report from a contactable consumer (patient, self-reported). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via unknown route, on 22Mar2021 (last Monday) as a single dose for COVID-19 immunisation. Patient's medical history included Bell's palsy. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Lot number and expiry dates were not reported) for COVID-19 immunisation. Patient stated that patient received COVID-19 Vaccine second dose last Monday, (22Mar2021). He had started with annoying headaches for 3-4 days. On Friday (26Mar2021), had lost control with talking, eyes were droopy etc. Patient mentioned that he had Bells palsy once before, and that now got it again. Patient asked if it would be possible that the vaccine caused the disease?. He mentioned that the hospital gave him Prednisone and Valtrex. Seriousness of the events was considered as hospitalization. Outcome of the events was unknown. Information on about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
61 2021-04-13 pain in extremity He received his vaccine, he did have a sore arm but nothing else. When he woke up today at 4/14/21 ... Read more
He received his vaccine, he did have a sore arm but nothing else. When he woke up today at 4/14/21 with an upset stomach, has been nauseated, feeling run down. He has thrown up 3 times. His bones are aching and light headed. He has not taken anything for the reaction, just trying to stay hydrated, very little appetite. Does have an appointment to see his doctor today at 4:20 PM.
61 2021-04-14 bell's palsy Bells palsey on left side. Had stiff neck several days before with first shot and more with second s... Read more
Bells palsey on left side. Had stiff neck several days before with first shot and more with second shot that escalated to bells palsey.
61 2021-04-14 feeling hot This patient came in to the community center to receive his 2nd dose of his Pfizer vaccine at approx... Read more
This patient came in to the community center to receive his 2nd dose of his Pfizer vaccine at approx 10:06am. At approx 10 minutes after sitting in the observation area, the patient started to fee hot, dizzy, some tunneled vision and nausea. This attendee did not have any sort of reaction to his first dose. This was brought to the attention of one of the observing staff members. This nurse, was called over to the patient. The attendee was asked to lay down on the cot provided and we elevated his legs. RN, measured his vital signs: bp 110/70, HR: 60, Resp 16, O2 97%. This patient denied any shortness of breath. Lung sounds were clear, and no wheezing or rhonchi were observed. This patient stated he has a history of Asthma and took his asthma medications this morning as normally directed. This patient was directed to lay down for approx 10 minutes, then stated he felt much better and wanted to sit up and take a sip of water. The attendee tolerated the water well. This nurse, advised for this attendee to stay for another 10 minutes until he had no symptoms present. The patient quickly felt better and stated that his wife was out in the car and would be driving him home. This nurse advised for him to go to the Emergency Room if he felt any of these symptoms again.
61 2021-04-14 pain in extremity After receiving my shot around 4:00 pm on April 13, 2021, I was restless and did not sleep well that... Read more
After receiving my shot around 4:00 pm on April 13, 2021, I was restless and did not sleep well that night. When I woke up on April 14, I was tired but otherwise felt fine except my arm was a bit sore. However, after working at home for a couple of hours, shortly before 10:00 am I began to feel nauseous. I rushed to the bathroom thinking I was going to throw up, and almost immediately fainted. My wife and sons found me on the floor and woke me up. I threw up shortly after and felt pretty lousy the rest of the day with low grade fever, chills, body aches, fatigue, and a headache. I began to feel better at night and had a good night of sleep. Today (April 15), I feel fine except I'm a little tired.
61 2021-04-15 bell's palsy 8 days post 2nd covid vaccine (given on 4/6/21), patient awoke with stroke like symptoms. Evaluated ... Read more
8 days post 2nd covid vaccine (given on 4/6/21), patient awoke with stroke like symptoms. Evaluated in the ER and diagnosed with Bell's Palsy.
61 2021-04-15 pain in extremity Joint pains. 1) Left should pain with shooting pain down the arm to the wrist. Occurs infrequently ... Read more
Joint pains. 1) Left should pain with shooting pain down the arm to the wrist. Occurs infrequently 2) Wrist pain will occur when using the joint. 3) Knee joint pain in both knee - stiffness after sitting or from waking up with difficulty standing 4) Lumbar back pain - have had issues with this area prior
61 2021-04-16 pain in extremity Skin on the side of my forearm is hypersensitive and paimful to the touch. It is the same arm as I r... Read more
Skin on the side of my forearm is hypersensitive and paimful to the touch. It is the same arm as I received teh injection. It first presented after my first dose (03/19/2021 and started to subside. After the second dose the pain and sensitivity increased. It has bee 1 week since second dose.
61 2021-04-17 weakness Substantial Fever, body aches, headache, weakness all over
61 2021-04-17 seizure Patient received vaccine was sitting for 15 minutes and got up in the middle of his 15 minutes to ap... Read more
Patient received vaccine was sitting for 15 minutes and got up in the middle of his 15 minutes to approach the pharmacist and the pharmacist sat him down again and he passed out onto the floor hitting his head with a cut on his eyebrow and nosebleed. Ems arrived and got patient back into chair and he again passed out and began seizing. He again regained consciousness and was taken away in a stretcher.
61 2021-04-18 feeling hot POST VACCINE PT BECAME DIZZY, DIAPHORETIC, HOT. TRANSFERRED TO OBS VIA W.C. PT REPORTS FEELING BETTE... Read more
POST VACCINE PT BECAME DIZZY, DIAPHORETIC, HOT. TRANSFERRED TO OBS VIA W.C. PT REPORTS FEELING BETTER ONCE PLACED IN TRENDELENBERG ON STRETCHER. VS MONITORED THROUGHOUT OBSERVATION. HX OF HTN, TAKES BP MEDS QHS. ONCE SYMPTOMS RESOLVED, PATIENT AND SPOUSE ESCORTED TO EXIT WITHOUT ISSUES AT 1200, INSTRUCTED TO MONITOR BP AND SEEK FURTHER EVAL/TREATMENT IF UNRESOLVED OR WORSENS. PER ON-SITE MD, PT EXPERIENCED CLASSIC NON SYNCOPAL VASOVAGAL REACTION-RESOLVED. 1120 INITIAL BP 193/100 HR 70 SATS 99% RA 1125 BP 185/94 HR 75 SATS 100% RA 1135 BP 186/105 HR 65 SATS 99% 1155 STANDING BP 175/98 HR 59 SATS 98%
61 2021-04-20 weakness 102 degree fever 8 hours, head ache 24 hours, nausea, weakness for 24 hours
61 2021-04-20 feeling cold Severe chills (2am 20 Apr thru 5am 20 Apr), fever to 103 (3am 20 Apr thru 3pm 20 Apr), mild fever (i... Read more
Severe chills (2am 20 Apr thru 5am 20 Apr), fever to 103 (3am 20 Apr thru 3pm 20 Apr), mild fever (intermittent, 9pm 20 Apr to present), severe fatigue, diarrhea, dizziness, periodic nausea (all thru current)
61 2021-04-21 numbness C/O N/V, SOB, Chills, funny taste in month.
61 2021-04-21 numbness Patient was vaccinated with first dose of Pfizer on 4/1/2021. Patient reports having no known allerg... Read more
Patient was vaccinated with first dose of Pfizer on 4/1/2021. Patient reports having no known allergies and no known chronic medical conditions. He states he experienced his "cheeks go numb" an hour following his first dose of the Pfizer vaccine. This symptom lasted 3-4 minutes. He denies having taken or consumed anything that would have brought on these symptoms. The numbness resolved on its own without medication. Patient consulted with primary care provider following adverse event.
61 2021-04-22 inability to speak, facial paralysis, slurring Pt presented for 2nd dose of Pfizer Covid vaccine on 4/5. for second Pfizer COVID vaccine, and repo... Read more
Pt presented for 2nd dose of Pfizer Covid vaccine on 4/5. for second Pfizer COVID vaccine, and reported to have Left facial droop, and slurred speech same night after first dose. He reports as soon as he made it home he "felt sleepy and went to bed, and woke up around 8:00 pm with my tongue swollen and Left facial droop, and unable to speak." States he did not follow up with PCP or ER.Uon assessment by LVN and MD facial droop swollen tongue still present 2nd COVID vaccine not give and instructed on EC visit. Pt diagnosed with CVA in EC. Pfizer noted as an allergy.
61 2021-04-22 weakness I had no ill reaction-no swelling, no redness, no fever, no trouble breathing at all. By next mornin... Read more
I had no ill reaction-no swelling, no redness, no fever, no trouble breathing at all. By next morning, my Parkinson's symptoms, overall weakness, "frozen foot" and (left) foot-turned-in-bent-at-ankle, resulting in my needing assistance to walk, get up out of chairs, use the bathroom, worse than I had experienced prior. Normally I have much relief with Rytary, Carbidopa-Levodopa, and deep brain stimulator, but nothing helped. I'm now at 65-70% of where I had been. While I can't say with certainty that my medication failure resulted from the vaccine, I have no other explanation. I would rather risk whatever one vaccine has done for me against COVID, than go through this again, or worse!
61 2021-04-22 pain in extremity First dose Sore arm; This is a spontaneous report received from a contactable consumer (reporting on... Read more
First dose Sore arm; This is a spontaneous report received from a contactable consumer (reporting on himself). A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL1284 and Expiry date: Mar2021), via an unspecified route of administration in Arm Left on 05Jan2021 13:30 (at the age of 61-years-old) as single dose for COVID-19 immunization. Medical history included supraventricular tachycardia, herpes virus infection, lymphadenectomy and idiopathic mesenteric lymphadenopathy. Concomitant medication(s) included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]); cyclobenzaprine (CYCLOBENZAPRINE); metoprolol (METOPROLOL) and atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that patient experienced first dose sore arm. Patient took second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL1284 and Expiry date: Apr2021), via an unspecified route of administration in Arm Left on 26Jan2021 13:15 (at the age of 61-years-old) as single dose for COVID-19 immunization. Second dose 8 hours post headache, sore arm and entire upper torso pain, chills and fever 101-102F 12 hrs. I was lethargic the whole next day with severe headache. Normal 2nd day after. Since the vaccination, patient not tested for COVID-19. The outcome of the event was recovering.
61 2021-04-22 pain in extremity Starting 3-4 days after injection, began to have increasing pain in buttocks. Pain became more seve... Read more
Starting 3-4 days after injection, began to have increasing pain in buttocks. Pain became more severe, spread to hips, then to knees/quadriceps over next 3 days - during this time, pain was relieved with Tylenol for 2-3 hours, then the pain would "break through" the Tylenol. Three days after onset pain was unbearable and consistent for 2-3 days. The pain slowly subsided over next 3 days without intervention. Morphine and Valium was required to manage pain in ER.
61 2021-04-23 muscle spasms Severe headache from neck to eyebrows. Chills, running 104.4 temp muscle cramps in legs, extremely t... Read more
Severe headache from neck to eyebrows. Chills, running 104.4 temp muscle cramps in legs, extremely tired
61 2021-04-23 pain in extremity Pain in left arm still persist. Pain is unexplained. It seems like mud is applied and it has dried o... Read more
Pain in left arm still persist. Pain is unexplained. It seems like mud is applied and it has dried out. it is kind of annoying pain. Pain keeps moving from lower part of arm (wrist) to shoulder. sometime it hurts then it goes down.
61 2021-04-24 weakness, muscle spasms, cold sweat muscle cramp; tightness in chest; shoulders cold sweat with no fever; body weakness; 7days brain fog... Read more
muscle cramp; tightness in chest; shoulders cold sweat with no fever; body weakness; 7days brain fog; This is a spontaneous report from a contactable consumer reported for himself that a 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733, expiry date: Jul2021) at the age of 61-years, via an unspecified route of administration in right arm on 29Mar2021 11:30 at 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. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient experienced 7days brain fog, muscle cramp, tightness in chest, shoulders cold sweat with no fever and body weakness. These events started since unknown date (reported as 28Mar2021, pending clarification). No treatment received for the adverse events. Outcome of the events was recovered/resolved. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
61 2021-04-24 weakness On Friday, April 23/ 2021 @4PM I began to feel pressure built up on my chest. @ 4:15 the pressure al... Read more
On Friday, April 23/ 2021 @4PM I began to feel pressure built up on my chest. @ 4:15 the pressure also built up on my neck. I was short of breath and I can feel the heartbeat way too high. I recall the person that gave me the first Pfizer shot to get ready for side effects after the second shot. @ 4:30pm the pressure was all over the back, the chest and the neck. Making things worse the jaw and lower teeth were also in extreme pain. I laid down on the sofa and must have passed out. 20 minutes later I began to come around but I was way weak and the heart beat was beginning to relax. The body pressure was present till 6pm I did not know what to do at that time other than take a nap. I was not able to eat any food until Saturday 6PM.
61 2021-04-24 slurring he had a stroke; felt pressure on his head; He had slurred speech; he fell as well; At approximately... Read more
he had a stroke; felt pressure on his head; He had slurred speech; he fell as well; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737) in left arm on 06Apr2021 10:30 am at single dose for COVID-19 immunisation. Medical history included ischemic cardiomyopathy, chronic heart failure, pace maker/dif, diabetes, high blood pressure. Concomitant medications in two weeks included aspirin, carvedilol, valproate semisodium (DIVALPROEX), furosemide, and other medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 16Mar2021 10:30 AM at 61-year-old in left arm at single dose for COVID-19 immunisation, received levofloxacin (LOVENOX) and experienced allergies. No other vaccine in four weeks. At approximately 10:00 pm on 07Apr2021, patient started having a fever and flu symptoms that lasted into the first day after taking the second covid shot. By the second day, on 08Apr2021 at 6:15 am, patient took a shower felt pressure on his head and his arms would not work. He had slurred speech, and he fell as well, his lip was curled up on one side and patient sated he thought he was in trouble. He was transferred to ER, and they said he had a stroke. He then went to the Neurological ICU where he stayed until his discharge three days later. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was hospitalization for 3 days. Treatment received for all the events in patient hospitalization. No COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was not recovered.
61 2021-04-24 pain in extremity Severe Headache; Muscle ache; Abdominal pain; lost his appetite; had a horrible feeling in his stoma... Read more
Severe Headache; Muscle ache; Abdominal pain; lost his appetite; had a horrible feeling in his stomach, almost like the stomach flu; cold and had trouble maintaining his body heat; significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week; nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick; Sore Arm; Runny Nose with Mucous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2, via an unspecified route of administration, administered in Arm Left on 31Mar2021 (Batch/Lot Number: EN6206) (at age of 61-year-old) as single dose for COVID-19 immunisation. Medical history included Slightly Diabetic from 2009 to an unknown date. The patient stated he doesn't smoke or do drugs, or drink and he tried to eat good healthy food. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 10Mar2021 (at age of 61-year-old) (Lot number: EN6200) and experienced sore arm and runny nose with mucous. The patient experienced sore arm on 01Apr2021, runny nose with mucous on 01Apr2021, nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick on 02Apr2021 , severe headache on 07Apr2021, muscle ache on 05Apr2021, abdominal pain on 02Apr2021, lost his appetite on 02Apr2021, had a horrible feeling in his stomach, almost like the stomach flu on 02Apr2021, cold and had trouble maintaining his body heat on 02Apr2021, significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week on 02Apr2021.Clinical course: The patient had his second shot last Wednesday, 31MAR2021, and he was calling to report his adverse side effects. The patient stated he had a sore arm which was okay and runny nose with mucous, which was similar to his experience with his first shot, but then things went downhill. The patient stated with the first vaccine, he had arm pain that evening and it really wasn't bad. Stated there was an hour where it was really intense like he got shot up with something pretty powerful, he had a yucky feeling like when you catch the flu and get the first kick and then it went away. Stated he had a runny nose that first came on and lasted pretty much until he got the second vaccine, stated it got not so severe and heavy and decreased until the second shot and then went up again. Stated with the second vaccine he lost his appetite and he developed nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick. Clarified he did not have vomiting or diarrhea. Stated he just had a horrible feeling in his stomach, almost like the stomach flu. The patient stated yesterday (07Apr2021) was bad and he spent the last 2 days in bed. Stated while he was sick, her ate half a sandwich, that was all he could stomach and could eat. Stated he had significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week. Stated looking at his waist line he can tell he has lost weight. Clarified most of the pain was in his lower abdominal pelvis region, large intestine area. Stated he had a severe headache yesterday (07Apr2021). Clarified that it has significantly improved. Stated he still felt tension in his head but nothing compared to yesterday (07Apr2021) with the pounding migraine type of headache. Stated he was cold and had trouble maintaining his body heat. The patient clarified the phases of his events mimic the flu but unlike the flu, he wasn't coughing, but he was having the physical pain of the flu but not the normal symptoms you would expect like heavy mucous, coughing, sneezing, like if he had the flu or a cold, but he felt like he was going through the flu. Stated he had muscle aches. States his back is normally okay but he injured it in the past and it started to hurt especially at the points that were injured. The patient stated just before he called, his husband brought him some soup and he just finished that and he didn't feel immediately sick after eating something so it seems to have significantly improved. Caller states yesterday (07Apr2021) was the worst. Stated he has isolated, he didn't have to go out and lives in the mountains, he only goes out for groceries and they bring it out to him. Stated he did go to the hospital where he received the vaccine, he could have picked up something at the hospital. Stated he hasn't exposed himself to anything, no bars, gym, church, he is not hanging out with anyone, he maintained as restrictive environment as one could have and he wears a mask when they are putting the groceries in his vehicle. Restated that yesterday (07Apr2021) and last night were the worst and everything has significantly improved. Treatment: Been in bed for the last 36 hours, today (08Apr2021) he is actually up enjoying a beautiful day. The events did not result in emergency room visit or physician office visit. AE(s) following prior vaccinations: Every time got flu shot, and he didn't get them anymore, he got sick as a dog for a couple of weeks, with yellow phlegm. Stated he thought it was supposed to protect him, why is he so sick and hacking up phlegm? Stated maybe he is one of those people that doesn't do well with vaccines. Stated this is a new type of vaccine MRNA and it could just be him. Stated not all vaccines, it seems like flu vaccine kicks him in the keister but has had other vaccines like the MMR and no issues with that, no pain no nothing. The outcome of events Sore Arm was resolved on 03Apr2021 and Runny Nose with Mucous was resolved on 06Apr2021 and of the rest of events was Resolving. No follow-up attempts are possible; No further information is expected.
61 2021-04-25 flushing Ringing, buzzing, chirping , humming in both ears general practitioner prescribed allergy medicine,... Read more
Ringing, buzzing, chirping , humming in both ears general practitioner prescribed allergy medicine, still have this side effect Dizziness - no treatment Ear ache , ears burning - no treatment Flushed feeling in head - no treatment Anxiety and stress - went to ER with chest pains, found nothing wrong with heart
61 2021-04-25 flushing Flushing, minor breathing issue, anxiousness occurring about 8 minutes after getting the vacciine. ... Read more
Flushing, minor breathing issue, anxiousness occurring about 8 minutes after getting the vacciine. Patient admitted to anxiety discorder. Nurse and EMT assessed patient and obtained vitals. Patient got out and walked and stated that he felt better.
61 2021-04-25 pain in extremity Zero symptoms after the first dose aside from a sore arm for 24 hours. Almost no immediate symptoms ... Read more
Zero symptoms after the first dose aside from a sore arm for 24 hours. Almost no immediate symptoms after second dose aside form a sore arm again for 24 hours. However, a few days after the second dose, I noticed a very slight metallic sort of buzzing or ringing in my ears. After consulting a week later with my family doctor, he mentioned the possibility of tinnitus and we have an appointment set with an ear/nose/throat specialist on May 3rd.
61 2021-04-25 pain in extremity Fever, pain from left arm to left ear, sweating
61 2021-04-26 pain in extremity Very sore arm 10 days post vaccination accompanied by sensitive teeth on left side of mouth and a st... Read more
Very sore arm 10 days post vaccination accompanied by sensitive teeth on left side of mouth and a stye on left eye. Recovery took 2-3 weeks
61 2021-04-27 weakness Fever, chills body aches no energy or appetite . Slept all day
61 2021-04-27 discomfort Arrhythmia lasting about 5 - 7 minutes. Unpleasant and got light-headed. Resolved itself instantaneo... Read more
Arrhythmia lasting about 5 - 7 minutes. Unpleasant and got light-headed. Resolved itself instantaneously.
61 2021-04-27 pain in extremity, feeling cold sweating; felt cold/intense cold even in his bones; He was told by the professional health care that... Read more
sweating; felt cold/intense cold even in his bones; He was told by the professional health care that he had small clots in his blood; death cause: Medication; arm started to sore; Doctor identified he had DVT; her husband during that night was not able to sleep; He started having fever; This is a spontaneous report from a contactable consumer (patient's spouse). A 61-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 21Mar2021 09:00 (Batch/Lot number was not reported) as single dose f(at the age of 61-year-old) or COVID-19 immunisation. Medical history included dialysis, diabetes mellitus, known allergies: A7, Penicillin, Aspirin, Iodine, Povidone, Pepcid, dyes, iodine allergy. The patient's concomitant medications were not reported. The patient previously took Aspirin, povidone and pepcid ac and experienced drug hypersensitivity with all. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced death cause: medication on 18Apr2021, he was told by the professional health care that he had small clots in his blood in Mar2021, felt cold/intense cold even in his bones on 21Mar2021, sweating on 26Mar2021, her husband during that night was not able to sleep on 21Mar2021, he started having fever on 21Mar2021, arm started to sore and DVT on 29Mar2021. The patient was hospitalized for he had small clots in his blood, felt cold/intense cold even in his bones, sweating for 27 days. The event DVT was medically significant. The course of events was as follows: After getting the vaccine in 21Mar2021 her husband during that night was not able to sleep. He started having fever and felt cold. Days later he continued with the symptoms. On 26Mar2021 after vaccination he had dialysis same day in the afternoon. When arriving home the person notifies symptoms of intense cold even in his bones and then he started to sweat excessively on 26Mar2021 (Friday). The reporter decided to take her husband to the emergency room on 28Mar2021 (Sunday) where he had a general checkup. He was told by the professional health care that he had small clots in his blood. After some time he had health complications where they had suggested to amputate some of the limbs because of this, the reporter alleges those complications were due to the vaccine. On Monday 29Mar2021 same symptoms reappeared and he was admitted to Hospital. Had a blood test and notified to health professional that blood presents small clots. His arm started to sore severely after the sample. Doctor identified he had DVT. Doctor decided to proceed with various medications. Patient received treatment and he was injected: Percose, Morphine, Benadryl, Triphetarin for blood clot reduction. The patient underwent lab tests and procedures which included blood test: blood clot in Mar2021, Sars-cov-2 Nasal swab test: negative in Mar2021 post vaccination. The patient died on 18Apr2021. It was not reported if an autopsy was performed. The outcome of death cause: medication was fatal, of the other events was unknown. Information about the lot/batch number has been requested.; Reported Cause(s) of Death: death cause: Medication
61 2021-04-28 pain in extremity Arm soreness which came up within hours of injection, slightly limited range of motion , got slightl... Read more
Arm soreness which came up within hours of injection, slightly limited range of motion , got slightly worse into the night but was gone by morning. Pain would be described as minor.
61 2021-04-30 migraine headaches; bad migraine/Migraine headache and headache which has not improved; This is a spontaneous... Read more
headaches; bad migraine/Migraine headache and headache which has not improved; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 16Mar2021 14:30 (Lot Number: EN 6208, Expiration date: unknown) as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced the day after he took the shot on 17Mar2021, a migraine, it was awful, the migraine came down to a headache and he haven't had that level of migraine. Since then his headache is not gone away and he does not know if he has migraine right now but it was not improved on 17Mar2021. Patient reported he was not going to take the second shot. But he is scheduled to take the second shot tomorrow, but there is no way he could take that. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of bad migraine. Nabumetone 500 mg twice a day was taken as treatment for migraine. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
61 2021-04-30 pain in extremity Sunburn-like pain on his back; Sunburn-like pain on his back; Rash on his back / patch-like rash on ... Read more
Sunburn-like pain on his back; Sunburn-like pain on his back; Rash on his back / patch-like rash on his back; Itching on his back; Left arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis. Concomitant products included TOZINAMERAN (COVID-19 VACCINE PFIZER). On 3rd March 2021, the patient received the 1st dose of Shingrix. On 8th April 2021, the patient received the 2nd dose of COVID-19 VACCINE PFIZER. On 4th March 2021, 1 days after receiving Shingrix, the patient experienced pain in arm. On 19th April 2021, the patient experienced pain burning, back pain, patchy rash and localised pruritus. The patient was treated with lidocaine, dermatologicals nos (Lotion) and ambiguous medication nos (Cortisone (Nos)). On 8th March 2021, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the pain burning, back pain, patchy rash and localised pruritus were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, pain burning, back pain, patchy rash and localised pruritus to be related to Shingrix. Additional details were provided as follows: The patient reported for himself. The patient was vaccinated with Shingrix in his left arm. The patient had left arm pain next day after vaccination with Shingrix. On 18th March 2021, the patient was vaccinated with 1st dose of Pfizer Covid vaccine in his right arm. On 8th April 2021, the patient was vaccinated with 2nd dose of Pfizer Covid vaccine in his right arm. On 19th April 2021, 1 days after receiving Pfizer Covid vaccine and 47 days after Shingrix vaccine, the patient experienced Sunburn-like pain, itching and rash on his back. On 26th April 2021, the patient experienced patch-like rash on his back. The patient used over the counter lotions, cortisone, and Lidocaine P. The patient did not receive his second Shingrix vaccination. The patient did not share any information except his name and date of birth. The lot number and expiration date of Shingrix vaccination was not known. The reporter did not share if he received his vaccine at a pharmacy or his Heath Care Professional's office. The reporter did not consent to follow up. It was unknown if the reporter considered the back pain, pain burning, patchy rash and localized pruritus to be related to Pfizer Covid vaccine.
61 2021-05-02 numbness On 4/14/2021 patient developed pain in left shoulder blade with numbness in the front of chest and u... Read more
On 4/14/2021 patient developed pain in left shoulder blade with numbness in the front of chest and under left arm and biceps, and broke out rash on Sunday 4/18/2021 and on Monday, 4/19/2021 he developed blisters and he went to Urgent care and was diagnosed with Shingles. He received a prescription for the rash, (Valacyclovir TID x 7 days), but he used Calamine lotion and applied that to the rash which improved. . Went to see his health care provider a week later on 4/26/2021. and received pain medication Tramadol, which was very helpful with reducing the pain. He was advised to get the 2nd dose of Pfizer vaccine on 4/29/2021. As of this date no complaints. He was encouraged to use V-Safe and he is being followed by them at this time.
61 2021-05-03 numbness, tingling About a week after the first vaccine pt started having numbness and tingling in the injected arm. He... Read more
About a week after the first vaccine pt started having numbness and tingling in the injected arm. He states it comes and goes and hasn't seemed to improve at time of second dose. He stated no previous issues with carpel tunnel or other nerve issues in his hand or arm. He did want to go ahead with the second injection.
61 2021-05-03 numbness muscle pulled in back of back, tips of fingers numb
61 2021-05-06 burning sensation I felt fine following the 2nd shot, for 48 hours, but unusally tired so I knew it must have been the... Read more
I felt fine following the 2nd shot, for 48 hours, but unusally tired so I knew it must have been the shot. The next day my sinuses became burning and I assumed it was hayfever because I had experienced some symptoms of that for the previous two weeks. But the next day, Tues., it was worst, like a bad cold (which all of this "reaction" may have been), but then the next 3 days I could barely get out of bed--and that's unusual because I run every day and nothing stops me. I had bad headaches for 5 days or so and that included coughing, from a dry cough at first to a very wet cough and very large thick segments of gelled mucous coming out of my sinuses, something I've never seen before. After almost two weeks I felt much better but was still coughing, and now three weeks later I'm still really tired, can't think as tightly as usual.
61 2021-05-06 pain in extremity, muscle spasms Day 1 headache and sore arm. Day 2 intermittent weakness in both legs and cramps in the calves. Day ... Read more
Day 1 headache and sore arm. Day 2 intermittent weakness in both legs and cramps in the calves. Day 3 gradual withdrawal of reactions. Early am Day 4 , while sleeping stabbing pain in liver and gallbladder area (under right rib). Pain came on 5-10 minute intervals for 4 hours. Day 4 was at a hotel in another city. Pain was gone by Day 5. Neck was sore throughout the 5 days post vaccine.
61 2021-05-10 muscle spasms Swelling, cramping, redness, pain, and warmth in left leg. He went to Urgent Care. The ultra sound l... Read more
Swelling, cramping, redness, pain, and warmth in left leg. He went to Urgent Care. The ultra sound lady said she saw a small clot. The PA he saw reported the radiologist did not diagnose a clot. The PA cautioned from prescribing any blood thinners for fear of interacting with DM medications (metformin and lisinopril).
61 2021-05-11 cold sweat having heart attack feelings; tightness and pain on the chest; tightness and pain on the chest; naus... Read more
having heart attack feelings; tightness and pain on the chest; tightness and pain on the chest; nausea; lightheadedness; fatigue; dizziness; shortness of breath; cold sweats; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 09:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Relevant medical history included type 2 diabetes and high blood pressure. The patient had allergy to some nuts. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, 24 hours after his first Pfizer shot, the patient thought that he was having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats. These events were resulted in a visit to the Emergency Room. The Hospital Emergency Room diagnosis was "anti-viral reaction to vaccine" for the adverse event. The patient received with IV treatment. As of 24Apr2021, the clinical outcomes of the events "having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats" were resolved on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.
61 2021-05-11 flushing Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection... Read more
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Additional Details: patient's husband says pt was admitted to hospital with burning in chest, heart, throat swelling, anxiety and trouble breathing.
61 2021-05-12 weakness diabetes/high glucose levels; Patient says he is feeling very weak; has fallen twice; This is a spon... Read more
diabetes/high glucose levels; Patient says he is feeling very weak; has fallen twice; This is a spontaneous report from a contactable consumer (patient's stepbrother). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Arm Right on 23Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 for covid-19 immunisation. The patient was feeling very weak and has fallen twice and no fever or flu like symptoms. He ended up going to the hospital where they did a blood test which came back showing he had very high glucose levels and he was now convinced that the vaccine has given him diabetes. The patient experienced Patient says he is feeling very weak and has fallen twice but no fever or flu like symptoms on 24Feb2021, high glucose levels and diabetes on an unspecified date. The patient underwent lab tests and procedures which included blood glucose increased: high glucose levels on an unspecified date.The patient was not tested for COVID-19 since the vaccination. Outcome of the events patient says he is feeling very weak and has fallen twice was not recovered and unknown for other events. Follow-up attempts are completed. No further information is expected.
61 2021-05-14 bell's palsy Bell's Palsy
61 2021-05-17 burning sensation, numbness, tingling On April 27 felt tingle / pulse shoot down left arm, on April 28 felt tingle / pulse shoot down rig... Read more
On April 27 felt tingle / pulse shoot down left arm, on April 28 felt tingle / pulse shoot down right arm, on May 1 fely tingle in legs knee down to toes and also arms , from that point I have have pins and needles, burn, tingle numb pulsing off and on in arms to fingers, knees to toes and also in face numbness , have seen muscles soften and skin sag and lost autonomic nerve sensation in privates area and have not had bowel movements for over a week and a half other than wit hlaxative until last 3 days have had very small bowel movements , also eyes had been for years but vision has gotten worse , additionally anxiety i high and not sleeping well as worry and concern increases .
61 2021-05-18 brain damage ED to Hosp-Admission Discharged 4/3/2021 - 4/10/2021 (7 days) Hospital MD Last attending ? Treatme... Read more
ED to Hosp-Admission Discharged 4/3/2021 - 4/10/2021 (7 days) Hospital MD Last attending ? Treatment team Severe sepsis with acute organ dysfunction Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Date: 4/10/2021 Admission Date: 4/3/2021 Length of stay: 6 Days PCP: MD Discharging provider: MD Admission diagnosis: Primary Admission Diagnosis Hospital Problems POA * (Principal) Severe sepsis with acute organ dysfunction Yes Left hip pain Yes Primary osteoarthritis of left hip Yes Intractable vomiting with nausea Yes Acute metabolic encephalopathy Yes COVID-19 virus infection Yes Gastrointestinal hemorrhage with hematemesis No Urinary tract infection associated with indwelling urethral catheter Yes HPI: Admitted with severe left hip pain and altered mental status. patient with history of stroke Was also found to have Covid positive at the time of admission Hospital Course: Following issues were addressed during this hospitalization Acute encephalopathy: At the time of admission Most likely secondary to gabapentin Held medication during this hospitalization and also stopped at the time of the discharge. Patient was started on this medication recently due to his left hip pain. COVID-19 infection D-dimer was elevated at the time of presentation. CT chest ruled out pulmonary embolism. Ultrasound did not reveal any DVT. Patient did not qualify for any convalescent plasma remdesivir during this hospitalization as he is saturating well on room air. Possible catheter associated urinary tract infection Patient with chronic indwelling Foley catheter. Urine culture grew Staphylococcus hemolyticus and Enterococcus faecalis faecalis. Patient was started on ampicillin during this hospitalization he completed the 5-day course. Sepsis ruled out at the time of admission Acute kidney injury present at the time of admission Suspect underlying chronic kidney disease Patient needs to follow-up with the PCP for the follow-up on the creatinine in 1 week. Left hip pain Patient underwent extensive work-up during this hospitalization. MRI of the left hip showed high-grade tear of the iliopsoas tendon. Patient was seen by orthopedics recommending continued therapy and pain management. Acute GI bleed, presented as coffee-ground emesis Acute on chronic anemia Iron deficiency anemia Underwent extensive work-up during this hospitalization. CT angiogram of abdomen pelvis revealed suspected bleeding in the stomach. Patient underwent EGD which showed severe esophagitis most likely cause of the bleed. Gastroenterology recommending continuing pantoprazole twice daily. Patient hemoglobin remained stable during this hospitalization. Biopsy did not reveal any H. pylori infection. Patient was seen by PT OT during this hospitalization who recommended acute inpatient rehab. But patient and family decided to take the patient home patient was discharged home in stable condition with home health.
61 2021-05-18 flushing Client received 2nd COVID vaccine of Pfizer (Lot# EW0185 expiration 05/23/2021). RN noticed Client t... Read more
Client received 2nd COVID vaccine of Pfizer (Lot# EW0185 expiration 05/23/2021). RN noticed Client turn red and become flushed to the skin. RN provided supplemental nutrition and fluids. Client accepted. At 1740 RN and PHN responded to this event. At 1741, vital signs are blood pressure 150/90, heart rate 100, oxygen saturation 96%. Client reports anxiety, no dizziness, no headache, no blurred vision, no chest pain. Client reports history of hypertension, takes blood pressure medication every morning (today's morning dose was administered via self at home), takes over the counter aspirin as needed, and no known allergies. At 1745, vital signs are blood pressure 144/88, heart rate 101, oxygen saturation 95%. Client reports no complaints with the 1st dose. Per Client had a very stressful day. The flush reaction of the face happened within 2 minutes of administration. RN educated Client in regards to ED precautions and common adverse effects of COVID vaccine. At 1750, vital signs are blood pressure 140/88, heart rate 90, oxygen saturation 98. Client reports symptoms have resolved and skin tone returned to appropriate coloration to ethnicity. At 1800, vita signs are blood pressure 130/88, heart rate 92, oxygen saturation 97%. At 1801, Client stood up with no complaints. At 1802, Client walked out of facility with a steady gait.
61 2021-05-18 grand mal seizure Autoimmune encephalitis with generalized tonic/clinic seizure.
61 2021-05-18 tremor Severe body aches, shakiness, and fever up to 102
61 2021-05-19 pain in extremity Patient presented at the pharmacy on 05/20/2021 stating he has arm pain from the COVID vaccine he re... Read more
Patient presented at the pharmacy on 05/20/2021 stating he has arm pain from the COVID vaccine he received 04/08/21. Patient states he has limited range of motion and the arm has pain radiating down. Patient received his second COVID vaccine in the left arm without incident.
61 2021-05-21 weakness Flu symtems for 3 days. Body aches, fever, weakness. After that, low grade fever from May 8 to pres... Read more
Flu symtems for 3 days. Body aches, fever, weakness. After that, low grade fever from May 8 to present (May22)
61 2021-05-25 tingling, numbness Numbess/tingling all through right arm, still ongoing. Some days not very much, some days its more ... Read more
Numbess/tingling all through right arm, still ongoing. Some days not very much, some days its more noticeable.
61 2021-05-26 pain in extremity blood pressure had dropped a lot/blood pressure dropped a good deal; his heart rate was 30 beats per... Read more
blood pressure had dropped a lot/blood pressure dropped a good deal; his heart rate was 30 beats per minute; Not feeling well; Sore arm; felt strange; his bone spur in his heel quit bothering him immediately/he can walk long distance/he would get that real soreness or pulling after a walk and that kind of stopped; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 09Apr2021 (lot number: EW0158), as 1st dose, single, for COVID-19 immunization, at a clinic. Medical history included high cholesterol (controlled with diet); bone spur in left heel (bone spur in his left heel began coming on gradually, probably for 10 or 12 years) which has gotten little worse and made it hard for him to walk in the evening, in long distances, it was like a knife in his heel and he would get that real soreness and pulling after a walk; and allergy to sulfa drugs, more specifically sulfa antibiotics (he was given them 25 years ago and had a reaction). The patient has not had any vaccines or shots for years. He reported that he is very healthy and has not had the flu or anything in 25 years. The patient does not smoke and is careful with what he eats. There were no concomitant medications. On 09Apr2021, within minutes of receiving the first dose of the COVID-19 vaccine, the patient was not feeling well, he felt strange. He wondered if it was his imagination or if something was going on. Then it got worse and worse within 12-15 minutes after the COVID-19 vaccine. The staff member sent paramedics over to him. The paramedics set him up with a blood pressure cuff and heart monitor. Apparently, his blood pressure dropped a lot/dropped a good deal and his heart rate went to 30 beats per minute. His heart rate is normally around 65 beats per minute. The paramedics informed him that if his blood pressure and heart rate didn't come up, he was going to have to go to the hospital. The paramedics instructed him to stand up and it seemed to bring his blood pressure and heart rate back up to normal. The patient reported that everything returned to normal within a 15-20-minute time frame. He was then able to leave the vaccination facility. His health care provider advised him not to take the second dose of the COVID-19 vaccine. His physician informed him that he could possibly go into cardiac arrest. The patient did not have any problems after that other than a sore arm later in the day on 09Apr2021. His arm was sore for a day or two. The patient stated that this was the only effect after the incident in the vaccination facility. The patient also reported that on the weekend after receiving the COVID-19 vaccine, in Apr2021, he can walk long distance and his bone spur in his heel quit bothering him immediately. He reported that if he walks a mile and back, it quit the hurt. He reported that he would get that real soreness or pulling after a walk and that kind of stopped. The patient thought this was really strange. The patient reported that he cancelled the appointment for the second dose and did not get it. He was a little apprehensive about the second dose of as he didn't know if his reaction would be worse. The patient asked if the vaccine is 80% effective after one dose, if Pfizer has heard of that type of reaction from others, if his reaction was rare, and if he should get the second dose of the COVID-19 vaccine. He mentioned that he would like to have a second dose of the Covid-19 vaccine, but he is afraid to get it because he doesn't want to go into cardiac arrest. The patient recovered from "blood pressure had dropped a lot/blood pressure dropped a good deal", "his heart rate was 30 beats per minute", not feeling well and felt strange on 09Apr2021, and from sore arm in Apr2021. The outcome of "his bone spur in his heel quit bothering him immediately/he can walk long distance/he would get that real soreness or pulling after a walk and that kind of stopped" was not recovered. No follow-up attempts are needed. No further information is expected.
61 2021-05-27 feeling hot AS SOON AS WE COMPLETED VACCINE , HE START FELLING HOT AND NAUSE AND HE SAID HE FEEL LIKES HE WILL... Read more
AS SOON AS WE COMPLETED VACCINE , HE START FELLING HOT AND NAUSE AND HE SAID HE FEEL LIKES HE WILL PASSOUT , WE GAVE HIM 1 TABLET OF BENADRYL 25 MG AND CALL 911 ,AFTER 5 MINUTES HE START FEELING GOOD AND EMS ARRIVED IN 10 TO 15 MINUTES CHECCK HIS BLOOD PRESSURE AND PULSE AND HE FELT GOOD AFTER 15 MINUTES AND WALKED TO HIS CAR.
61 2021-05-27 pain in extremity swollen and red leg; swollen and red leg; blood clot in right leg; Pain in right leg; her husband ca... Read more
swollen and red leg; swollen and red leg; blood clot in right leg; Pain in right leg; her husband cannot walk, he is limping; her husband cannot walk, he is limping; This is a spontaneous report from contactable consumers (patient and wife). A 61-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 61-year-old via an unspecified route of administration on 21Apr2021 13:00 (Lot Number: ER3732; Expiration Date: 30Nov2022) as 2nd dose, single for covid-19 immunisation. Medical history included ongoing high cholesterol and ongoing prostate [having to go to the bathroom frequently] (prostatic disorder). The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 61-year-old on 26Mar2021 3:45 pm for covid-19 immunisation. Concomitant medications included (LIPITOR) ongoing since unspecified date (reported as 3 or 4 years ago) for blood cholesterol increased, and tamsulosin on an unspecified therapy dates (reported as he has been taking it for years now) for prostate/having to go to the bathroom frequently (prostatic disorder). The patient did not receive other vaccine in the last four weeks prior to vaccination. The patient received the vaccine from a pharmacy. The patient reported that one week after getting the second vaccine, he had pain in his right leg (28Apr2021). He stated that he did know what was going on, but he continued to work. He added that last Monday (10May2021) it got worse, so he contacted his primary care doctor and he went today (12May2021) because his leg was swollen, red and he had pain. His doctor sent him to the ER (emergency room). The patient mentioned that the ER did a CAT scan on 12May2021 and found that he had a blood clot in his right leg (reported as 10May2021). The patient's wife comes on the line and stated the reason her husband called to report was because it could be from the vaccine, but they are not sure. The wife added that her husband went to the pharmacy to pick up the blood thinner and they told him to report this. She also stated that all the side effects could happen, but he did know the side effects and he just wanted to report because the pharmacy told him to report. She mentioned that her husband started complaining his leg hurt because he has to do yard work. She states that it got worse and worse and she saw his leg get swollen and she was like you need to go to the doctor. The wife mentioned that the leg is more swollen and painful, but is the same, her husband cannot walk, he is limping on an unspecified date in 2021. She stated that her husband has just started taking medication, yesterday and today. The outcome of the event thrombosis leg was not recovered while the outcome of the other events was unknown.
61 2021-05-28 numbness numbness on his left leg and one time with left arm/His left leg went numb seven or eight times; cou... Read more
numbness on his left leg and one time with left arm/His left leg went numb seven or eight times; could not walk; This is a spontaneous report from a contactable consumer (the patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW0164, expiry date Aug2021), via an unspecified route of administration on 13Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: hypertension and allergic to bees. The patient had an EpiPen. He would have to use it if he ever got stung. He has never had to use an EpiPen. Concomitant medications included: hydrochlorothiazide/ lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) taken for hypertension, for maybe 8 years. The patient had other unspecified concomitant medications. After receiving the Pfizer COVID vaccine, the patient experienced numbness on his left leg and one time with left arm. His left leg went numb seven or eight times. His left arm went numb one time. He thought maybe it was just going to sleep. He usually slept on his arm, and it woke up that way. But he was walking, and it went numb; it was very strange. There was no pain. It began about two and a half weeks ago (2021). It has happened twice today, so he thinks it is getting worse. It was also lasting longer. Today (unspecified date 2021), his left leg went numb so much that he could not walk. He was walking, and he had to stop and stand there for 10 minutes before the feeling came back. It was very strange. His leg numbness was the most serious today. After this last episode of leg numbness, he called his insurance company, and made an appointment with his medical provider on Monday. He was reluctant to take the second dose of the COVID vaccine. The patient stated he occasionally took vitamin D, fish oil, vitamin C, and aspirin. The outcome of the event could not walk was unknown. The outcome of the other event was not recovered.
61 2021-05-29 pain in extremity First day: Arm pain, followed by a severe headache lasting approximately 24 hours, with pain in extr... Read more
First day: Arm pain, followed by a severe headache lasting approximately 24 hours, with pain in extremities, joints, ankles, wrists, knees, neck pain, high fevers and intermittent sweating. Something that triggered me and that I had never suffered before was ALLERGIES TO POLLEN. Today a week later I still feel sick from it. A lot of headache, runny nose, and sneezing. I assume they are allergies to pollen because I took some pills for that {CLARITIN} and I calm down and we feel them a bit, however I do not take it off.
61 2021-05-31 burning sensation, numbness Doctors are suspecting I might have mucous or blood colitis, we are just not sure; Hands, both right... Read more
Doctors are suspecting I might have mucous or blood colitis, we are just not sure; Hands, both right-left hand and wrist, right-left foot and ankles and toes, heels, right-left knees are numb; Burning sensation; Doctors are suspecting I might have mucous or blood colitis, we are just not sure; Shooting pain like flu; This is spontaneous report from contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, (patient not sure if it's right arm or left arm) on 13Mar2021 (Batch/Lot Number: EP7534) as 1ST DOSE, SINGLE, for covid-19 immunisation. The patient took the second dose on 04Apr2021 (Batch/Lot Number: ER8732). The patient medical history and concomitant medications were not reported. The patient stated that "I wanted to report about suspected side effects to covid-19 shot. I'm not sure if it's the Covid-19 shot or not or has to do with it but I wanted it to be documented may there's some coincidence, you can tell me about. All extremities hands, both right-left hand and wrist, right-left foot and ankles and toes, heels, right-left knees are numb. Burning sensation, shooting pain kind of like flu but no body temperature change, body temperature is 97.7 down there, it's been occurring now past my 2nd shot." The patient later corrected it as," It's 5-10 days after the 1st shot." When paraphrased, the consumer stated," I've got a number of doctors working on trying to figure out what's wrong with me. So, if we cannot find anymore answers then I'm sure, I'll contact Pfizer. I don't know if it has anything to do with the shot or not, I don't even know if the side-effects are from Pfizer or not. Doctors are suspecting I might have mucous or blood colitis, we are just not sure." When asked for the anatomical Site of administration of Vaccine: The patient stated, "I'm not sure if it's my right arm or left arm." For the event start date: patient stated, "18 or 19 June, somewhere around there. I am not sure. (pending clarification)" The patient also added: "Do you guys also report to VAERS? I don't know my physician asked to say, if you guys report to VAERS, otherwise I should call VAERS and report my symptoms." The outcome of the events was unknown. Information on the Lot/Batch number has been requested.
61 2021-05-31 pain in extremity very sore arm at the injection site; very sore arm at the injection site; This is a spontaneous repo... Read more
very sore arm at the injection site; very sore arm at the injection site; This is a spontaneous report from a non-contactable consumer(patient). This 61-year-old male patient reported that he received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 17Jan2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient (frontline worker), received his first dose of the Pfizer COVID vaccine on 17Jan2021. On an unspecified date the patient had a very sore arm at the injection site which he was never had with a vaccine before, and the patient had no side effects except these. The outcome of the events was unknown. No follow up attempts are possible. Information about lot/batch cannot be obtained. No further information is expected.
61 2021-06-01 numbness, weakness, pain in extremity He got his vaccine, he had a very, very bad headache. About 3 weeks later his neck stiffened. He d... Read more
He got his vaccine, he had a very, very bad headache. About 3 weeks later his neck stiffened. He developed a pain in his chest, stabbing in nature, down his neck, left arm, arm pit, down his side and through to his back and down his spine. He also has had numbness in his hands. He went to the ER because he thought he was having a heart attack, and they did a bunch of tests on him including a COVID test which was negative . They did a chest x-ray, EKG, blood work and possibly some others, and everything seemed to be OK, and could be a neuromuscular thing. He then went to see his PCP the next day who reviewed the ER results, and he sent him to a cardiologist and he is in the process of having tests done with him. He also has an APT set up with a neurologist and an Orthopedist as it has been 5 weeks since this started, and the pain is fairly severe. He has an overall feeling of weakness, light headedness and nothing really relieves the pain and has been using Advil. They told him to take Advil. The cardiologist has not given him any results yet. He did ask his PCP and his cardiologist if they felt that it was due to the vaccine, perhaps a delayed reaction and they told him that they would not rule that out.
61 2021-06-03 numbness swelling and numbness in my face and lips; swelling and numbness in my face and lips; swelling and n... Read more
swelling and numbness in my face and lips; swelling and numbness in my face and lips; swelling and numbness in my face and lips; swelling and numbness in my face and lips; Racing heartbeat; I have degenerative disc disease and arthritis. After 1 day those symptoms have almost disappeared; This is a spontaneous report from a contactable consumer, reporting for himself. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in left arm on 01Mar2021 11:15AM (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. Relevant medical history included asthma, arthritis, degenerative disc disease and type 2 diabetes. The patient had latex allergy. He did not have COVID prior to vaccination. Concomitant medications were not reported. About 30 minutes after injection, the patient started to get some swelling and numbness in face and lips, racing heartbeat. Breathing was normal. As of 05Mar2021 he was still having these symptoms. On a positive note the patient had degenerative disc disease and arthritis. After 1 day those symptoms have almost disappeared. No treatment was received. The patient was not tested for COVID after vaccination. The events were non-serious and not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
61 2021-06-03 pain in extremity Nothing major; slight redness at injection site and a sore arm for 24 hours; Sore arm; This is a spo... Read more
Nothing major; slight redness at injection site and a sore arm for 24 hours; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6195), via an unspecified route of administration on 04Mar2021 12:30 as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has not had other vaccine in four weeks. The patient has no history of COVID prior vaccination. The patient was not COVID tested post vaccination. The patient experienced nothing major; slight redness at injection site and a sore arm for 24 hours on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
61 2021-06-07 numbness, tingling reports numbness and tingling on L hand radiates to elbow continues with symptoms at this time. Mo... Read more
reports numbness and tingling on L hand radiates to elbow continues with symptoms at this time. Motor skills intact
61 2021-06-07 pain in extremity Sharp pain in his arm; This is a spontaneous report from a contactable consumer or other non-hcp (Pa... Read more
Sharp pain in his arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0172) via an unspecified route of administration (Age at vaccination 61-year) in Left Arm on 06May2021 13:30 as single dose for COVID-19 immunization. It was reported that the second dose of the COVID vaccine given over 21 days after the first dose. Medical history included allergy to animal (The only allergies he has are to dogs, cats, horses, seasonal allergy); ragweed; blood pressure measurement, He takes a blood pressure medicine and a cholesterol medicine. He started taking all of his medications after age 55, blood cholesterol from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide taken for blood pressure measurement; amlodipine besilate taken for blood pressure measurement; lisinopril taken for blood pressure measurement; rosuvastatin taken for blood cholesterol from an unspecified start date and ongoing. On 06May2021 the patient experienced sharp pain in his arm. On an unspecified date the patient underwent lab tests and procedures which included blood test: nothing for his arm. The seriousness of the event was reported as non-serious. The clinical outcome of the event was not recovered. Batch/Lot number was obtained. Further information has been requested.
61 2021-06-08 weakness, feeling cold I got a sinus headache; body ached; Terrible feeling; lost all energy; was cold; This is a spontaneo... Read more
I got a sinus headache; body ached; Terrible feeling; lost all energy; was cold; This is a spontaneous report from a contactable consumer(patient). A 61-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581) via an unspecified route of administration, administered in right arm on 18Feb2021 12:00 as single dose for COVID-19 immunization. Patient medical history included Early Onset Alzheimers, high blood pressure, acid reflux, diverticulitis, and allergies to pollen and ragweed. Past drug event included Lipitor orifarm, amlodipine for allergies (Hypersensitivity). The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via intramuscular, administered in arm Left on 28Jan2021 12:00 as single dose for COVID-19 immunization. Patient stated that on 19Feb2021 01:00 when she was in store, she had terrible feeling came over her. She lost all her energy, she got a sinus headache, she was cold, her body ached all over. She had to leave the store. Barely had enough energy to walk from the car into her house. The patient did not receive any other vaccines prior to the COVID vaccine in four weeks. Patient received other medications in two weeks after vaccination. Patient did not receive any treatment for AE. Patient was not tested covid prior vaccination or post vaccination. The clinical outcome of events was not recovered.
61 2021-06-08 trigeminal neuralgia ACTIVATION OF TRIGEMINAL NEURALGIA FROM 04/16/2021 RESULTING IN DEBILITATING PAIN CONTINUING TO THIS... Read more
ACTIVATION OF TRIGEMINAL NEURALGIA FROM 04/16/2021 RESULTING IN DEBILITATING PAIN CONTINUING TO THIS PRESENT REPORT
61 2021-06-09 discomfort Chronic allergic reaction. Severe itch, rash, welts, hives and discomfort
61 2021-06-10 burning sensation Approximately 1 month after second injection, I began having the sensation of menthol in my mouth, n... Read more
Approximately 1 month after second injection, I began having the sensation of menthol in my mouth, nose, tongue, throat, and lungs. The sensation is constant and continuous. It seems to be getting stronger with time.
61 2021-06-10 migraine First shot induced week and a half migraine headache. Second shot has caused extreme fatigue and eve... Read more
First shot induced week and a half migraine headache. Second shot has caused extreme fatigue and every joint in my body hurts to the point I have experiences a severe reduction in quality of life. So, extreme fatigue and pain. I just can't seem to catch up on sleep and have to think twice about the next move due to the pain it will cause.
61 2021-06-10 pain in extremity I woke up with terrible lower back pain and shooting pains in legs. I had difficulty and extreme pai... Read more
I woke up with terrible lower back pain and shooting pains in legs. I had difficulty and extreme pain standing and walking. Doctor's examination revealed inflammation of lower back around spine. X-rays revealed arthritis in lower back and minor disc slippage/bulging, as expected for age. Since no back injury or strain, Doctor diagnosed it as probable immune system going into over-drive due to vaccine and attacking lower back arthritis resulting in inflammation and pinched nerves. Treatment was muscle relaxers for a few days and Physical Therapy for lower back. Cleared sufficiently in 2 weeks to get second dose of vaccine on time, with no problem.
61 2021-06-11 migraine Migraine headache after the shot. Since the shot on 3/16/2021 I have a headache. This headache is ... Read more
Migraine headache after the shot. Since the shot on 3/16/2021 I have a headache. This headache is 24/7 all day every day. It has not gone away or improved. I have visited my primary care physician, ENT doctor, ophthalmologist and two neuologists. I have been prescribed numerous presciptions. I have had a CT scan, MRI and MRA. My headache has not improved after 3 months from the initial vaccine. I had no history of headaches prior to receiving the vaccine.
61 2021-06-12 bell's palsy Bell's Palsy
61 2021-06-12 numbness Patient came in for his second dose after 3 weeks and I asked him if he had any issues with his firs... Read more
Patient came in for his second dose after 3 weeks and I asked him if he had any issues with his first dose. He responded that his arm became numb after his first dose and it is still numb.
61 2021-06-13 inability to speak, mild one side paralysis, speech disorder He reports changes in speech noted by neighbor on 5/8/21. Admitted for acute stroke on 6/12/21.
61 2021-06-14 weakness Sudden onset of right upper back pain with radicular symptoms radiating to right pinky on afternoon ... Read more
Sudden onset of right upper back pain with radicular symptoms radiating to right pinky on afternoon of 3/5/2021. Discovery of right pinky weakness in extension and abduction with EMG confirmation of Parsonage Turner Syndrome on 6/8/2021
61 2021-06-20 muscle spasms Legs ache/cramp when standing or walking. Unknown cause--not circulatory or nervous system. Taken ... Read more
Legs ache/cramp when standing or walking. Unknown cause--not circulatory or nervous system. Taken off medication-Atorvastatin. Stopped taking the Vitamin D/Calcium. High Blood Pressure is being controlled. Using a CPAP machine (1 month now) for treatment of sleep apnia.
61 2021-06-23 numbness, slurring 30 minutes after vaccination he did not feel good, has droopy eyes , slurred speech, numbness of lef... Read more
30 minutes after vaccination he did not feel good, has droopy eyes , slurred speech, numbness of left arm. high blood pressure, headach, shortness of breath 2 days after vaccination he feels better but still has mild headache , pressure behind eye, Rt eyelid ptosis, numbness of left upper arm and slight shortness of breath
61 2021-06-24 difficulty speaking I received my vaccine, I was monitored for 15 min with no effects. I walked outside to my truck whe... Read more
I received my vaccine, I was monitored for 15 min with no effects. I walked outside to my truck when I got in I could not breathe, I was gasping for air. I am on 02 for my Copd and had to turn it up and sit for 30 minutes until I could drive because I could not catch my breathe. I lost my voice it is raspy and have had a COPD exacerbation since my vaccination. I have been hospitalized twice since receiving the vaccine, and still have no voice. No treatments are working.
61 2021-06-25 pain in extremity Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; Co... Read more
Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; pain with any and all movement of left arm, pain at rest; This is a spontaneous report from a contactable physician (patient). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL926L, Pfizer NTEC), via intramuscular route of administration in left arm on 01Feb2021 at 10:30 (at the age of 61-years-old) as 2nd dose, single for covid-19 immunization. The most recent COVID-19 vaccine was administered in the public health clinic/veteran's administration facility. The patient medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 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-19 vaccine. The patient previously took naproxen for hypersensitivity and experienced periorbital oedema. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL2183, Pfizer NTEC), via intramuscular route of administration in left arm on 11Jan2021 at 14:00 as 1st dose, single for covid-19 immunization. On 02Feb2021 patient experienced constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder, i.e., 40% reduction in range of motion, positive tenderness to palpation, pain with any and all movement of left arm, pain at rest, but no redness or swelling or bruising. Events resulted in disability or permanent damage. Treatment received for the events included NSAID and physical therapy. The clinical outcome for the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the 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.
61 2021-06-25 seizure, weakness Received the first Pfizer COVID vaccine (ew0161) injected at 4:30PM on 29 April 2021 at the Pharmacy... Read more
Received the first Pfizer COVID vaccine (ew0161) injected at 4:30PM on 29 April 2021 at the Pharmacy. He became weaker, more tired and sleep afterwards, He developed decreased oral intake. He was unable to recall his name, so family brought him to the ER. In the ER he was noted with significant anemia Hgb 6.5 and thrombocytopenia with platelet of 6. There is question of hemolysis with reticulocyte 8, LDH 1757, total bill 3.8. There is elevated D-dimer and renal function. Hematology consultation was placed for possible TTP versus COVID vaccine induced thrombocytopenia. PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times on 4, 5, 6, 8, 9, 10, 11, 12, 13, 17, 19 May 2021. Received Rituximab 375 mg/m2 = 731 mg IV weekly X 4 on 5, 13, 19, 26 May 2021. Completed high dose steroids 1000 mg x 3 days AMS and seizures 2/2 TTP related metabolic encephalopathy(i mproved), Small R parietal subdural hematoma­ likely related to TTP. No focal deficits. Treated for TTP with plasmaphoresis.initially alert but not oriented. Had an episode of seizure, intubated for airway protection Patient was hospitalized for 15 days 4-19 May 2021. He was in ICU for 1 week and 8 days in general ward. He was unconscious for the first week experienced 2 episodes of seizure. He has been comatos since he developed the first episode of seizure on 5/5/21. He developed another episode of seizure after the brain MRI on 5/5/21. PT discharged on 19/5/21 and continued blood works and Ritoximab therapy as out patient. Assessment: TTP, based on his clinical features including altered mental status, fe1er, hemolytic anemia and thrombocytopenia, renal insufficiency, and peripheral smear with 7-8 schistocytes per HPF (5/4/2021). Adam Ts 13 activity <3 Hemolytic anemia, severe thrombocytopenia 212 TTP with AdamTs13 deficiency In setting of hemolytic anemia, thrombocytopenia, AKI and AMS Hgb 6.5, Bili 3.8, LOH 1757, ARC 3.6 significant for hemolytic anemia on adm Peripheral smear showed anisocytosis, microspherocytosis and possible 1 schistocytes Platelet 6, multiple petechiae, no active bleeding, guaiac negative. Received 1U PRBC. Direct Coombs test -ve , Tbili elevated Plasmic score 6 Acute kidney injury 212 TTP vis Prerenal (Resolved) , Hyponatremia (resolved) FENA 0.5 Hematology followup: TTP (THROMBOTIC THROMBOCYTOPENIC PUPURA) 5/14/21 He developed a new ulcer in the mid of tongue. He coughs and sputum is clear. He feels better. Sip plasmapheresis and rituximab infusion yesterday. 5/13/21 He continues improling. Good appetite. He still coughs with blood streak, slightly pinkish sputum. 5/12121 His mental status is back to baseline. He is able to eat regular food and walk inside his room. Clo cough with blood streak, slightly pinkish sputum. 5/10/21 Fully alert and awake, but reported confusion and forgetful episodes. Eating better. Clo tightness in arms 5/9/21 More alert and awake. Started eating. Feeling tired. Clo mild pain at shoulders. Sip 1 unit PRBCs 5/8/2021 Mild improvement. Wife is at bedside. No acute overnight events. Still has intermittent confusion. Surgery re-placed left IJ Shiley for PEX 5/7/2021 He has intermittent confusion and irritation, mixed with short-term of AAO x 3. He pulled out his PEX line and has urinary incontinence. He is NPO and remains sleeping most of time. 5/6/2021 Sip extubated. He appears tired, but arousable, follows commands and carries normal communication with b/I symmetric strength with no motor deficits. Afebrile since last night. 5/5/2021 He developed 1 episode of seizure. Sip Ativan and 1 dose of propofol for intubation. He has been in comatose since then. Brain MRI was performed this afternoon. He developed another episode of seizure after the brain MRI. Sip 1 unit packed RBC 5/4/2021 and 1 unit packed RBC 5/5/2021. He de1.eloped mild bleeding from the bronchial suction and Foley catheter. He de1.eloped fe1.er temperature 101 during the first plasmapheresis. Temperature was 104 about 2 hours after the first plasmapheresis. He has had persistent high fe1.er since then. 5/4/2021 Lab showed WBC 7.1, Hb 6.5, pit 6, MCB 92.1, neut 68%, re!8%, PT 14, PTT 30. 5, D-dimer 2.19, fibrinogen 490, CMP normal except Ca 8.1, Glu 189, BUN 47, Cr 1.57, T bili 3.9, direc!0.9, and AST 56. LOH 1757, TSH 4.828, serum HIV and hepatitis panel negati1.e, COVID-19 Ag, SARS-CoV2 Rapid and Flu Ag negati1.e. 5/5/2021 WBC 21,500, hemoglobin 6.2, platelets 17,000, neutrophils 69%, PT 14.9, PTT 28.3, D-dimer 5.5, glucose of 296, BUN 63, creatinine 2.18, total bilirubin 2.5, albumin 3.6, LOH 891, AST 57, ALT 32, alkaline phosphatase 51. Laboratory results: WBC H 13.2 (MAY 14) H 11.6 (MAY 13) H 13.4 (MAY 12) H 16.8 (MAY 11) ? Hgb L 9.9 (MAY 14) L 11.3 (MAY 13) L 10.8 (MAY 12) L 10.4 (MAY 11) Hct L 30.2 (MAY 14) L 33.3 (MAY 13) L 31.5 (MAY 12) L 31.2 (MAY 11) Pit L 92 (MAY 14) L 58 (MAY 13) L 63 (MAY 12) L 74 (MAY 11) Risk Assessment: Denies Alcohol Use Substance Abuse Risk As sessment: Denies Substance Abuse Tobacco Risk Assessment: Denies Tobacco Use
61 2021-06-27 cold sweat I received the Pfizer shot in my left arm. The arm was sore at the shot location for 3 days...On the... Read more
I received the Pfizer shot in my left arm. The arm was sore at the shot location for 3 days...On the fourth day around 1:30 in the morning I woke up in a cold sweat and I felt my heart racing and also uneven heart beat. My blood pressure was up to 150/100. Over the next 20 hours this condition subsided and finally went away completely after 20 hours or so.
61 2021-06-28 impaired body coordination Pt presented to the ER with x5 days of dizziness, ataxia , and lightheadness. Imaging studies showe... Read more
Pt presented to the ER with x5 days of dizziness, ataxia , and lightheadness. Imaging studies showed and Acute left Cerebellar Infarction. Patient was recommended for inpatient acute rehab upon discharge which he refused, patient discharged home with home health services.
61 2021-06-29 weakness Chills; Lack of energy; slight fever; This is a spontaneous report received from a non-contactable c... Read more
Chills; Lack of energy; slight fever; This is a spontaneous report received from a non-contactable consumer, the patient. A 61-years-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6205) via an unspecified route of administration in the right arm on 12mar2021 at 1:30 for COVID-19 immunisation. TMedical history included asthma and sinus. Concomitant medications included antibiotics received within two weeks. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. and 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 experienced Chills, lack of energy and slight fever on 20Mar2021 at 9.00.The patient did not receive any treatment for reported events. The clinical outcome of the events Chills, lack of energy, slight fever was not recovered . No follow-up attempts are needed. No further information is expected.
61 2021-06-29 pain in extremity some stomach cramps; Bit of dizziness; Diarrhea issues; Arm Soreness; This is a spontaneous report f... Read more
some stomach cramps; Bit of dizziness; Diarrhea issues; Arm Soreness; This is a spontaneous report freceived rom a contactable other health care professional. A 61-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration and administered in left arm on 05Feb2021 10:00 (at age of 61 years) as dose 1, single for COVID-19 immunization. The patient didnot had covid-19 and was not tested for covid-19 prior vaccination. The patient was not tested covid post vaccination. The patient had no other vaccines in 4 weeks. The reporter was not aware of known allergies. The patient medical history was not reported. Concomitant medications included levothyroxine (LEVOTHYROXINE), vitamin D NOS (VITAMIN D NOS). The patient experienced arm Soreness, some diarrhea issues the first 2 days with some stomach cramps, he have a bit of dizziness that he awoke to this morning. The patient didnt received any treatment for events. The outcome of events was recovering. Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
61 2021-07-06 numbness Dec 7, 2020 felt chest pain on deep inspiration with fatigue, malaise over 7 days. No cough, no feve... Read more
Dec 7, 2020 felt chest pain on deep inspiration with fatigue, malaise over 7 days. No cough, no fever, no headache, no smell or taste alteration. On Dec 31 developed aching pain right shoulder scapular area, on Jan 5 developed weakness in the right arm and hand with intrinsic hand muscles weak and wrist flexion extension weak. Transient numb feelings in the right little finger. Diagnosed by myself as a Neurologist as an immune mediated motor brachial plexopathy affecting C6,7,8 and T1 myotomes. Prednisone 60 mg/ day for 5 days followed by a tapering dose completed. Complete recovery in 8 weeks.
61 2021-07-07 burning sensation, numbness and pain in extremities, muscle spasms, numbness, tingling Peripheral Neuropathy symptoms; tinnitus/Ringing/buzzing/chirping/humming in both ears; difficulty c... Read more
Peripheral Neuropathy symptoms; tinnitus/Ringing/buzzing/chirping/humming in both ears; difficulty concentrating; Extreme sensitivity to sound; Vertigo; Dizziness; Earache; Anxiety; Chest pains; Chest stress; Spasms in chest and back; Began to get blur in right eye; Bowel movements changed; Numbness on face: lips, checks, forehead; Muscles have shrunk throughout body; Joints popping; Neck ache; Throat tight; Face and smile have changed; Hair is thinner; Hair gotten gotten more grey since these issues; Feet burning; numbness and tingling sensation in both legs to feet and both arms to hands and extremities; Back aching; muscle weakness; Brain fog; Fatigue - constantly feel like laying down; Difficulty Sleeping through night/Unable to nap throughout day; feet aching in joints; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0150) via an unspecified route of administration, administered in left arm on 30Mar2021 at 14:45 as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included finasteride, ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride. The patient previously took augmentin s. On 03Apr2021 at 18:00, the patient experienced tinnitus/ringing/buzzing/chirping/humming in both ears, difficulty concentrating, extreme sensitivity to sound, vertigo, dizziness, earache, anxiety, chest pains, chest stress, spasms in chest and back, began to get blur in right eye, bowel movements changed, numbness on face: lips, checks, forehead, muscles have shrunk throughout body, joints popping, neck ache, fatigue - constantly feel like laying down, throat tight, face and smile have changed and hair is thinner. The outcome of the events was not resolved.
61 2021-07-08 numbness Stroke; Blood pressure high; Vision peripheral decreased; Joint stiffness; Numbness on left side of ... Read more
Stroke; Blood pressure high; Vision peripheral decreased; Joint stiffness; Numbness on left side of body; This is a solicited report from non-Pfizer sponsored marketing program based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3921608-00). A contactable consumer reported that a 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Mar2021 at age of 61 years old (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from 2016 (Batch/Lot number was not reported) and ongoing, at unspecified dose for moderate to severe adult crohns disease. Medical history included alcohol use started from 1976, rarely use beer and red wine; tobacco use from 1976 to 2021, a pack of cigarettes a day; and moderate to severe adult crohns disease. Concomitant medications included clopidogrel bisulfate (PLAVIX) and acetylsalicylic acid (BABY ASPIRIN); both taken for prevent another episode of stroke. The patient previously received the first dose of bnt162b2 intramuscularly in Mar2021 at age of 61 years old for COVID-19 immunisation. The patient experienced stroke, blood pressure high, vision peripheral decreased, joint stiffness, numbness on left side of body on 14May2021. Event stroke was serious per hospitalization, other events were reported as non-serious. Event details: On 14May2021, the patient experienced numbness on left side of body and peripheral vision on left side was affected. On the same day, he had stroke and was hospitalized due to that. He had physical occupational therapy after within two weeks when he returned home from the hospital. His blood pressure was high but could not remember the exact number. His joints got stiff with colder weather. He had unspecified high blood pressure pill as part of his concomitant medications. The action taken in response to the events for adalimumab was dose not changed. The outcome of event stroke was resolving, outcome of event blood pressure high was resolved, outcome of event joint stiffness was not resolved, outcome of other events was unknown. Causality for adalimumab: The reporter's causality for the events of stroke, blood pressure high and vision peripheral decreased with adalimumab was not related. The reporter's causality for the events of joint stiffness and numbness on left side of body with adalimumab was not provided. AbbVie's opinion was that there was no reasonable possibility that the events of stroke, blood pressure high, vision peripheral decreased, joint stiffness were related to adalimumab. Causality for bnt162b2: The reporter's causality for the events of stroke, blood pressure high and vision peripheral decreased with bnt162b2 was not related. The reporter's causality for the events of joint stiffness and numbness on left side of body with bnt162b2 was not provided. The reporter's assessment of the causal relationship of the events joint stiffness and numbness on left side of body with the suspect product bnt162b2 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. No follow-up attempts are needed. Information on the lot number cannot be obtained.; Sender's Comments: The events stroke, blood pressure high, vision peripheral decreased, joint stiffness, numbness on left side of body were considered as unrelated tot he use of bnt162b2. Patient received 2nd dose of bnt162b2 in Mar2021 and the events occurred on 14May2021. The temporal relationship between the events and bnt162b2 is weak.
61 2021-07-10 difficulty speaking his first cup of coffee about killed him, it tasted so bad; dryness in the mouth; his voice has chan... Read more
his first cup of coffee about killed him, it tasted so bad; dryness in the mouth; his voice has changed to raspy; his urine has a smell; lethargy; metallic taste in the mouth; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 61-years-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 08Jun2021 (age at vaccination 61-years) (Batch/Lot Number: EN0180) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient states coffee tastes strange/bad and this is ongoing but had improved some. Caller states starting out his taste was completely gone, his first cup of coffee about killed him, it tasted so bad. Caller states he has dryness in the mouth every day and he was drinking more water. Caller state he normally drinks a lot but this is more. Caller states his voice has changed to raspy most of the time and his urine has a smell. Caller states it was not like when he eats asparagus but another smell he hasn't had before. Caller states it started the morning after on 09Jun2021. Caller states his coffee is not back to normal taste yet, it still just tastes weird. Caller states he was also lethargic but that has improved some. Caller states he figured that out because he usually only has 1 cup of coffee and he was having 2-3 cups so he could stay focused and work, it was kind of weird. He also states he had a metallic taste in the mouth and for a while he had to brush his teeth 5 times a day. Outcome of the events was not recovered.
61 2021-07-12 seizure Had a seizure that lasted an hour and 15 minutes. My blood pressure and heart rate have been unstabl... Read more
Had a seizure that lasted an hour and 15 minutes. My blood pressure and heart rate have been unstable since the seizure.
61 2021-07-14 weakness Fever, Afib, weakness, chest pain, tachycardia
61 2021-07-17 feeling hot Muscle weakness; tired; Feeling hot; eyeball pain; Headache; Caller is the patient that received one... Read more
Muscle weakness; tired; Feeling hot; eyeball pain; Headache; Caller is the patient that received one dose of the Moderna Covid vaccine on 20 Jan 2021. Yesterday he received the Pfizer Biontech covid 19 vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program support. A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0198, expiry date: not reported) via an unspecified route of administration, administered in Arm Left, on 30Jun2021 at 15:00 ( at the age of 61 years), as 0.3 ML single for covid-19 immunisation. The patient received covid-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot Number: 027L20A), via an unspecified route of administration, on 20Jan2021 at standard dose, in left arm, for covid-19 immunisation and had a bad reaction to it. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior vaccination (within 4 weeks) was reported as the patient had shingles vaccine about a month ago. Family Medical History Relevant to AE was reported as no. On an unspecified date, the patient had experienced muscle weakness, tired, feeling hot, eyeball pain, headache. Reported feeling a little bit of eyeball pain, not bad and a little bit of a headache. The symptoms started the night before the day of reporting and most of the effects were on that night and on the morning of reporting. Stated his cup of coffee made him really hot. Side effects were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Adverse events did not require visit to emergency room or physician office. The outcome of the event headache was reported as recovered. The outcome of other events was unknown.
61 2021-07-17 pain in extremity, weakness It feels like I had pulled a muscle and noticed pain in movement and lack of strength.; Pain in arm;... Read more
It feels like I had pulled a muscle and noticed pain in movement and lack of strength.; Pain in arm; It feels like I had pulled a muscle and noticed pain in movement and lack of strength.; It feels like I had pulled a muscle and noticed pain in movement and lack of strength.; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533), via an unspecified route of administration in the left arm on 23Mar2021 at 18:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications of the patient included atorvastatin (MANUFACTURER UNKNOWN) 20 mg and acetylsalicylic acid (ASPIRIN) low dose for unknown indication from an unknown date. The patient did not have allergies to food, medications, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, the patient experienced pain in arm, loss of strength, pulled muscle, pain upon movement. The patient reported pain in the left arm which persisted until the day. It felt like he had pulled a muscle and noticed pain in movement and lack of strength and felt like someone had repeatedly punched his upper arm. The pain was persisted for 6 days so far. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, loss of strength, pulled muscle, pain upon movement was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
61 2021-07-20 numbness, weakness Swelling and lots of pain in left arm at injection site, radiates up to left side of neck, left inne... Read more
Swelling and lots of pain in left arm at injection site, radiates up to left side of neck, left inner ear and left side of back of my head. panful headaches, pain in all my bones, vomiting, feverish , extremely tired and in bad mood. Chills and numbness on the left side of my face, including left side of my mouth and left eye making me almost lethargic and extreme bad mood. Light bother me a lot, feel nauseas. I am extremely weak when walking and have to make a great effort to walk since is extremely painful and I don't have much strength. Everything hurts, especially when I walk, I feel very weak.
61 2021-07-25 tenderness Did well with first shot. Second shot was okay, pain and tenderness in shoulder. Did not worry abo... Read more
Did well with first shot. Second shot was okay, pain and tenderness in shoulder. Did not worry about it at first, figured it was vaccine related. 2 weeks later i was still having issues, noted weakness when reaching up and out to pick up things. Got to point I was reaching across body with right arm/hand. 2+ months later still having issues reaching for medicine in medicine cabinet, keys in closet, soap dispenser at work. Got to point i was dropping things. Thinking i somehow unknowingly injured myself and needing to get better quickly (ice, heat, Tylenol, limited use was not working), went to orthopedic 7/19/21.
61 2021-07-26 flushing I was immediately confused about where I was at, when leaving the vaccination site. I immediately f... Read more
I was immediately confused about where I was at, when leaving the vaccination site. I immediately felt flush with red splotches on my face. I came home and took a nap just to sleep it off. I woke up with severe tinnitus, a headache, and brain fog. Both the tinnitus and headaches have only gotten worse. The flush feeling, (suspecting higher blood pressure than usual), comes and goes with more frequency as time goes by. The ?brain fog? has been more like brain damage. At first, I just couldn?t think. My ability to think has slowly improved, but it is no where near the same as my abilities prior to the vaccine. My memory has been impaired, both long term and short term. My hand/eye coordination has been impaired. Prior to the vaccine, I didn?t feel my age. After the vaccine I felt like I aged 25 years in a week. I need to figure out what is going on inside my head, and what can be done about it. The degeneration is a serious concern. Both in the severity of the adverse reactions, and in the permanence of the damage. This will be devastating if I?m entering early stages of dementia, decades before the course of natural causes of aging.
61 2021-07-27 pain in extremity Vertigo; Dizziness; Arm pain; Fatigue; This is a spontaneous report from a non-contactable consumer,... Read more
Vertigo; Dizziness; Arm pain; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 61-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 04Apr2021 at 13:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history was 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 on unknown date as a single dose 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 05Apr2021 the patient experienced vertigo, dizziness, arm pain and fatigue. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vertigo, dizziness, arm pain and fatigue were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
61 2021-07-27 tingling Felt tight around right shoulder joint centered on 1st injection site; Right side of body didn't wor... Read more
Felt tight around right shoulder joint centered on 1st injection site; Right side of body didn't work correctly. Right leg and arm felt odd, muted sensation in right arm and leg not numb, tingling or pins and needles feeling; Lack of fine motor control in right fingers; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8727) via an unspecified route of administration in the arm left on 30Mar2021 at 12:00(at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included borderline diabetes and body mass index (30BMI). Patient had no allergies to food, medications or other products. Concomitant medications included metformin (MANUFACTURER UNKNOWN), ascorbic acid, copper gluconate, zinc oxide, tocopheryl acid succinate, xantofyl, zeaxanthin (AREDS 2 VISUAL ADVANTAGE), cetirizine hydrochloride (ZYRTEC), cannabidiol (CBD OIL) and glucosamine (MANUFACTURER UNKNOWN) all for unknown indications from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6205) via an unspecified route of administration in the arm right on 09Mar2021 at 12:00(at the age of 61-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 01Apr2021 at 07:00 the patient experienced lack of fine motor control in right fingers and right leg and arm felt odd, muted sensation in right arm and left; not numb, tingling or pins and needles feeling. On 06Apr2021 the patient experienced tight around right should joint. He woke up 2nd day after the second dose, the right side of his body didn't work correctly. Lack of fine motor control in right fingers which got better during the day, almost 100% . He called and doctor said he has heard several cases like this and prescribed anti-inflammatory medications. Symptoms lessened each day and by 06Apr2021 he was walking normally, right fingers regaining fine motor control but feel tight around right shoulder joint centered on 1st injection site. The event lack of motor control and tingling resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tingling and lack of motor control and included treatment with (SULINDAC) 200mg twice daily. The clinical outcome of the event lack of motor control, tingling and feel tight around right shoulder was recovering. No follow-up attempts are needed. No further information is expected.
61 2021-07-28 feeling of body temperature change, weakness tired; has no energy; can't think straight; dizziness; he has developed two spots on his right leg w... Read more
tired; has no energy; can't think straight; dizziness; he has developed two spots on his right leg where the skin has fell off; two spots on his right leg that the skin fell off and swelling really bad; two spots on his right leg that the skin fell off and swelling really bad; throbbing; bad headache; feels hot and cold; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (at age of 61 years old), (Batch/Lot Number: unknown) as dose 2, single for COVID-19 immunisation. Medical history included two heart attacks, three stent implants, and his lung had separated, also he had tube in his chest. He had to have six bypass open heart surgeries. His first heart attack was at age 55. Patient was taking unspecified concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on 15Jun2021, (at the age of 61 years old), in left arm as single dose for COVID-19 immunization. The patient experienced dizziness and he has developed two spots on his right leg where the skin has fell off and are throbbing and swelling really bad for no reason, had bad headaches and feels hot and cold on 16Jul2021 (Friday). The patient stated he can't think straight right now and also stated he is tired, has headaches, and has no energy. If he gets up and walks around he gets dizzy. The headaches are constant. The patient stated he was calling because his son wants to take him to the ER. The outcome of the events was not recovered.
62 2021-01-03 tingling Stuffy nose tingling lips tingling face i took 50 mg of over the counter benedryl..symptoms resolve... Read more
Stuffy nose tingling lips tingling face i took 50 mg of over the counter benedryl..symptoms resolved
62 2021-01-04 pain in extremity Right arm soreness Dec 24 , Fatique on Dec 25 , Severe Chills DEC 26 and fever of 101.5
62 2021-01-05 night sweats, tremor Chills, followed by shaking chills, myalgias, vomiting (x1), headache, lethargy. Chills, myalgias, ... Read more
Chills, followed by shaking chills, myalgias, vomiting (x1), headache, lethargy. Chills, myalgias, headache and lethargy lasted all night then took Naproxen in the AM and was able to go to work. Stayed on Naproxen all day and all the next night with no additional symptoms (other than extreme tiredness) throughout the day until night two had drenching night sweats throughout the entire night (changed drenched t-shirt 5 times, soaked sheets and pillow case, until up to go to work at 6:00 AM. Since morning no additional symptoms including no tiredness/lethargy. I currently feel completely normal. Last dose of naproxen was at 6:00 AM and no symptoms since. Currently 1:45 PM.
62 2021-01-05 pain in extremity PATIENT REPORTED A SORE ARM THE DAY FOLLOWING THE VACCINATION. THE PAIN SUBSIDED BY THE END OF THE S... Read more
PATIENT REPORTED A SORE ARM THE DAY FOLLOWING THE VACCINATION. THE PAIN SUBSIDED BY THE END OF THE SECOND DAY. ON DAY 4, THE PATIENT AWAKENED WITH FEVER, HEADACHE, BODY ACHES, CHILLS, SEVERE FATIGUE, SOB AND COUGH. ON MONDAY, JANUARY 4, THE WAS GOT FEELING ANY BETTER AND WITH TO SEE A PROVIDER AT MEDICAL CENTER. HE WAS GIVEN A CHEST X RAY AND LABS. HE WAS GIVEN A RAPID FLU AND COVID ANTIBODY PCR TEST BOTH NEGATIVE. HE DID NOT REPORT TO THE HEALTH DEPARTMENT AND THE HOSPTIAL DID NOT THINK FEEL THE SYMPTOMS WERE RELATED TO COVID VACCINATION. HEALTH DEPARTMENT ONLY FOUND OUT TODAY DURING F/U PHONE CALL WITH PATIENT. PATIENT IS RECOVERING AT HOME. AS OF TODAY, HE FEELS HE IS GETTING BETTER.
62 2021-01-06 flushing Syncope Hx of syncopal episodes during any procedures, per ED note. Narrative: c/o of feeling flushe... Read more
Syncope Hx of syncopal episodes during any procedures, per ED note. Narrative: c/o of feeling flushed and pt. asked to lay down @11 am in the observation area. Staff able to get pt. to cart before she "passed out." She immediately responded but RRT was called to assess the patient. BP low, per RRT (84/54 P 53, 108 /65 P 51) and pt. was taken to the ED at 1112. No SOB, nausea noted. Per ED and final report was that the reaction was not an allergic reaction nor a side effect of the injection.
62 2021-01-06 pain in extremity Fever 102.1, bone, joint, muscle pain, chills, headache, malaise, sore arms lasted 24 hours, took T... Read more
Fever 102.1, bone, joint, muscle pain, chills, headache, malaise, sore arms lasted 24 hours, took Tylenol, which cut fever and made me feel a little better, and the next day I felt normal again. I had no reaction to 1st dose.
62 2021-01-07 weakness, feeling hot, cold sweat Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness ... Read more
Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine; Postnasal drip in throat; Feeling warm then really hot; Feeling weak; Clammy; sweaty; As if he was going to pass out; almost like a vagal reaction if you got a needle or were scared; vagal reaction but delayed; Heart might have been beating fast; Experience is like the dizziness related in the signs of a severe allergic reaction; Experience is like the dizziness related in the signs of a severe allergic reaction; Anxiety; anxious; This is a spontaneous report from a contactable physician (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left deltoid, on 30Dec2020 10:30, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing mild intraocular pressure. The patient's concomitant medication included unspecified eye drops for a mild intraocular pressure. The patient previously took tetanus vaccine and experienced vagal reaction and passed out (in his childhood). The patient's past COVID tests were always negative. On 30Dec2020, the patient received it at a facility where he is a physician on staff, and they started giving it that day. It was administered by a pharmacist who was very clean and professional, and everything was fine. The patient received the COVID-19 vaccine in the left deltoid and felt pinched when the vaccine was administered, and he felt fine. He did not have any immediate reaction. He sat down, then got up and was standing talking to some colleagues, and about 10 to 15 minutes later, they were talking and felt a little postnasal drip in throat. His colleagues said that is what they felt as well. About 10 minutes later, the patient was feeling warm then really hot to the point where he felt the need for cool air. He added feeling weak and clammy as if he was going to pass out. He started to feel weak and warm and almost like a vagal reaction if you got a needle or were scared. It was almost like he felt hot, sweaty, and weak and feeling like he needed to get to a cool place and sit down. The patient's heart might have been beating fast, but he did not check his pulse. The patient went outside where the temperature was in the thirties and cold. The patient broke out in sweat and felt weak. The patient sat down, and it was cold outside, and he felt better. It passed and he felt fine after that. The symptoms lasted 10-15 minutes top, and it was resolved after the peak. The patient had soreness at the muscle site which got better overnight; little muscle soreness from the vaccine. The patient then got better and felt no other symptoms. He looked up the side effects and talked to the pharmacist. He spoke with a pharmacist, who provided the information on the reported adverse reaction of the COVID-19 vaccines and the signs of a severe allergic reaction included in the PI. He is not an allergic type person. He is familiar with those reactions and never had any trouble. He wasn't quite sure if it was related but then said it is probably somewhat related. The patient explained that he doesn't have any of the reported adverse reactions in the PI; but his experience is like the dizziness related in the signs of a severe allergic reaction in the PI, and he did feel that his heartbeat was fast. He is fine now though. The patient asked if his event is related to the vaccine and what is the impact on getting the second dose when reacting to the first. The patient was thinking that this event is a vagal reaction but delayed. He also explained that he was speaking with his colleagues, right after receiving the COVID-19 vaccine, regarding postnasal drip reaction. The patient also wondered if anxiety related to this discussion could have triggered his symptoms. Originally, he thought it was just him. But after talking to colleagues, maybe he was just a little anxious. He did not feel anxious going in. He did not need any intervention. He did not take any diphenhydramine hydrochloride (BENADRYL) or anything. He sat and rested, and it passed. He has been fine since. He needs a second dose in 3 weeks. There is not a lot of information about the side effects. It was not like he got a rash. He did not have any swelling of the tongue or throat. He just wanted to find out about if he should get the second dose. He really wanted to get the second dose. He just wanted to know if this was common or a concern and should he take the second dose. There were a lot of people getting the vaccine and this was not anything that stopped anyone from getting it. He is just trying to make sure and see how likely it was that it was related to the vaccine and how does it affect him getting the second dose. The patient was recovering from "Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine". The outcome of "Postnasal drip in throat" and "Anxiety; anxious" was unknown. The patient recovered from the other events on 30Dec2020. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
62 2021-01-08 pain in extremity insidious onset lateral right foot pain at fibularis tendons from lateral malleolus to the base of 5... Read more
insidious onset lateral right foot pain at fibularis tendons from lateral malleolus to the base of 5th metatarsal
62 2021-01-09 pain in extremity, bell's palsy Sore arm, tender under arm, headache, nausea, joint pain, made Bell?s palsy start
62 2021-01-10 facial paralysis, bell's palsy, involuntary muscle movements, mild one side paralysis Bell's Palsey- 1-10-21- c/o rt eye not closing all the way the night before, lower lip shifted to le... Read more
Bell's Palsey- 1-10-21- c/o rt eye not closing all the way the night before, lower lip shifted to left side with decreased movement and pt reports trouble drinking fluids. Physician assessment- vss, left lower lip decreased movement rt side, lt sided weakness, some pain in eye, eye red and injected. prescribed prednisone. Assessment 1-11-21- patient eye droop visibly improved, still left sided weakness and having issues drinking, due to hx herpes cold sores prescribed famciclovir in addition to prednisone.
62 2021-01-10 facial paralysis Bell's Palsy; This is a spontaneous report from a contactable physician (patient). A 62-years-old ma... Read more
Bell's Palsy; This is a spontaneous report from a contactable physician (patient). A 62-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on left arm on 19Dec2020 19:00 at single dose for COVID-19 immunisation. Known allergies: No. Other medical history: None. No other vaccine in four weeks. No other medications in two weeks. The patient experienced bell's palsy on 03Jan2021 21:00 and required visit to physician office. Covid test type post vaccination: Nasal Swab (PCR) on 29Dec202: Negative. Therapeutic measures were taken as a result of bell's palsy included Prednisone, Valtrex. Outcome of event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible association, causality between event Bell's palsy and BNT162B2 vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
62 2021-01-10 face paralysis, facial paralysis Woke up 1/4/21 with right sided facial weakness consistent with Bell's Palsy. Started high dose Pre... Read more
Woke up 1/4/21 with right sided facial weakness consistent with Bell's Palsy. Started high dose Prednisone and Valtex. Received IVIG infusion on 1/6/21 and 1/7/21. Mild improvement 1/11/21.
62 2021-01-10 flushing After the vaccine, pt experienced facial flush. Pt was given Benadryl 50 mg at 1:05 pm on 1/6/21
62 2021-01-10 hot flush Rash to Left torso spreading to midline of abdomen and to left side of back. Observing for past 30 ... Read more
Rash to Left torso spreading to midline of abdomen and to left side of back. Observing for past 30 hours. Slightly itching and internal hot flashes occasionally
62 2021-01-11 feeling cold Chills, Rigors, extreme sensation of being very cold with intense lethargy, Low grade fever 100.3d... Read more
Chills, Rigors, extreme sensation of being very cold with intense lethargy, Low grade fever 100.3degrees po. The reactivity was intense enough to be described as incapacitating for a period of approximately 10 hrs
62 2021-01-12 flushing flushing and light headed
62 2021-01-13 weakness Developed fever 102.7 F; Chills; Extreme weakness; This is a spontaneous report from a contactable h... Read more
Developed fever 102.7 F; Chills; Extreme weakness; This is a spontaneous report from a contactable healthcare professional who reported for himself, a 62-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0140) at the hospital, via an unspecified route of administration in the left arm on 07Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included CVA no residual, patent foramen ovale and known allergies to iodine. Concomitant medications included apixaban (ELIQUIS) and atorvastatin (ATORVASTATIN). Patient did not receive other vaccines in four weeks. On 08Jan2021 at 06:00 AM, the patient developed fever 102.7 F, chills and extreme weakness. Treatment for the events included Tylenol, tepid bath and "cleep". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. The outcome of the events was not recovered.
62 2021-01-19 tremor, unresponsive to stimuli Shaking and then became unresponsive
62 2021-01-21 numbness, weakness Right arm numbness that radiated to right side of the neck. Weakness headache and shortness of brea... Read more
Right arm numbness that radiated to right side of the neck. Weakness headache and shortness of breath, difficulty swallowing.
62 2021-01-21 night sweats DAVELOPED HEADACHE, BODY ACHES, FEVER, BACK ACHE, EXTREME CHILLS, NIGHT SWEATS, EXTREME FATIGUE
62 2021-01-24 numbness On January 18, 2021, I experienced extreme weakness of both legs to the extent that I was unable to ... Read more
On January 18, 2021, I experienced extreme weakness of both legs to the extent that I was unable to stand. I experienced an exacerbation of baseline numbness over many areas of my body. I had an elevated resting heart rate of over 108 bpm. I was transported by ambulance to that afternoon. I was admitted in the early morning hours of January 19, 2021. I was diagnosed with, "Exacerbation of multiple sclerosis; SIRS (systematic inflammatory response syndrome). I was given multiple intravenous antibiotics. I had a CAT scan. I had a chest x-ray. I had many blood tests. The adverse event resolved on its own. I was discharged January 16, 2021.
62 2021-01-25 hypersensitivity of all senses fever 103.8, shaking chills, extreme fatigue, muscle aches, disorientation, skin extremely sensitive... Read more
fever 103.8, shaking chills, extreme fatigue, muscle aches, disorientation, skin extremely sensitive to touch
62 2021-01-28 numbness Approximately 8 mins after receiving vaccine, complained of numbness to left side of face, gums and ... Read more
Approximately 8 mins after receiving vaccine, complained of numbness to left side of face, gums and lateral tongue to midline. No other symptoms of adverse reaction and vital signs were stable. Numbness progressed from lateral aspect of tongue to midline so MD ordered Benadryl. Symptoms resolve approx. 40 mins after Benadryl dose
62 2021-01-31 facial paralysis, muscle spasms, face paralysis, numbness Patient reports having his flu vaccination in November 2020 and his Pfizer COVID-19 vaccination on 1... Read more
Patient reports having his flu vaccination in November 2020 and his Pfizer COVID-19 vaccination on 12/22/2020. 10 days later he noticed bilateral leg cramps subsequently leading to numbness in his feet, weakness in his feet, numbness on side of his legs, both hands and upper back. 2 to 3 days prior to admission on 1/2/21 he has noticed right-sided facial weakness andhas noticed increasing shortness of breath on exertion. He was initially seen by PCP who suspected Guillain-Barré syndrome and had a PFT done which showed reduced tidal volume and FEV1 He was seen by neurologistand had EMG nerve conduction studies which confirmed demyelination & patient has been sent to the hospital for IVIG treatment. Per PT note from 1/30: "UE ROM: WFL UE Strength: WFL, reports grip weaker from baseline LE ROM: WFL LE Strength: proximal WFL, ankle DF/ PF 2+/3-/5             Coordination: reports no deficits with finger to nose B Sensation: numbness B hands; B feet numbness and reports weight bearing feels like standing on something squishy Balance: WFL over level surfaces, able to compensate with strength Posture: midline Other: R side facial droop, able to close R eyelid Bed Mobility: mod independent Transfers: modified independent, no device; able to perform controlled eccentric lowering stand > sit Gait Level of Assistance: Modified independent, requires aide device or extra time Assistive Device: None Distance Ambulated (ft): 10 ft Gait: pt ambulating in room without device, appears mildly unsteady with decreased heel strike with increased foot flat contact, mild increased lateral postural sway (increased with retrowalk). No frank LOB. Stairs: verbally reports has been performing stairs sineonset of symptoms, stairs are hard but able to perform, improved with UE support when available, requires increased time and fatigues quickly Endurance: neuromuscular fatigue, requires increased rest breaks" He was admitted to hospital from 1/28-2/2 for 5 treatmens of IVIG. He had improvement of his SOB and numbness but has not had full resolution of symptoms.
62 2021-01-31 facial paralysis headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of ... Read more
headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient receive first dose of bnt162b2 (lot number: EL3249, Pfizer), via an unspecified route of administration in right arm (shoulder) on 16Jan2021 06:30 at single dose for covid-19 immunization. Medical history included hypertension, gout, BP (blood pressure) abnormal, blood cholesterol abnormal all from an unknown date and unknown if ongoing. Concomitant medication included daily losartan for blood pressure, rosuvastatin calcium (CRESTOR) for cholesterol. The patient experienced headache, 10 hours later symptoms of fatigue and bell's palsy on 16Jan2021 16:00 about 10 hours after vaccination. Therapeutic measures were taken as a result of events. He was prescribed Prednisone 6 tabs PO (per oral) for 5 days, tapering down 1 tab daily. B12 Shot in 19Jan2021. He had an MRI (magnetic resonance imaging) appointment on 20Jan2021. His BP and cholesterol are both under control. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. No additional vaccines administered on same date of the Pfizer suspect. The adverse event was not required a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Family Medical History included: Mother died of cancer in the early 90s. Dad died of heart failure in the early 80s. The outcome of events was not resolved.
62 2021-01-31 sciatica, pain in extremity Worsening of sciatica in right leg. I don't believe this is related to the vaccine but understand it... Read more
Worsening of sciatica in right leg. I don't believe this is related to the vaccine but understand it is appropriate to report any effects which are temporally related to the vaccine
62 2021-02-01 slurring Pt had some amazing hallucinations and was actively communicating while I believe he was asleep. He... Read more
Pt had some amazing hallucinations and was actively communicating while I believe he was asleep. He called me on the phone and his voice was slurred and he thought he was being held down by some things that were flying around. I was able to direct him to sit up after ensuring him that he wasn't being held down and eventually get him to walk to the bathroom, turn on the light and look in the mirror and describe to me what he saw (he lives at a different address than I do). By this time, he had "woken" up and his voice was no longer slurred and he was "making sense". My concern was that he had had a stroke or Bell's palsy or something. He was fine and slept well the rest of the night. I will bring him to my home after his second shot just in case this happens again. He hallucinated after his anti-anxiety medications for the first couple of weeks and to a more minor amount with his other medications, again for the first couple of weeks. I am assuming that his brain reacted to the vaccine with hallucinations but I don't know. This may be nothing or it may be something that other patients are experiencing, who the heck knows.
62 2021-02-04 hot flush Blood pressure was high; tired from the night before; Itchy; slight headache; little lightheaded; He... Read more
Blood pressure was high; tired from the night before; Itchy; slight headache; little lightheaded; Heart racing; panic attack; Hot flashes; Sweating; Chills; achy/body aches; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer reported for himself, a 62-year-old male patient who received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration (reported as by injection) to left arm on 14Jan2021 at 3pm at single dose to prevent COVID/COVID-19 immunization. Medical history included anxiety. Concomitant medications included antidepressants. The patient received his first dose of Pfizer COVID vaccine last 14Jan2021 at 3pm, and everything went well. When he left the place, he had a slight headache. He had to stay there for 15-20 minutes to make sure he had no reaction. He just got a little lightheaded, he didn't think much, and it didn't get worse. The patient took 2 paracetamol (TYLENOL) and forgot about it. It went away for a while. He took the shot at 3 pm and he took paracetamol at 4 pm. Later that night, about 10 pm, everything kicked in. He was sick again at 10:30 pm, or so, the headache was gone for several hours. He was ok between 4 pm and 10 pm. Then about 10 to 10:30 pm, when he went to go to sleep, his heart started racing, like he was having a panic attack, then he started getting hot flashes, sweating, chills, and aching, and this went all night from like 10 pm to 11 to the next morning. He had a doctor's appointment to get his knee examined for an upcoming knee surgery. The patient clarified that he didn't go to the doctor because of the symptoms, he went for his knee. He asked the doctor, before getting examined, and the doctor said he got off easy, as the doctor himself was sick for 3 days. The patient asked the doctor if he could take something to calm down, as his blood pressure was high on 15Jan2021 at 8 am. They had taken his blood pressure to examine his knee, and the doctor said it was alright. He was prescribed with alprazolam (XANAX), and the doctor said it would be fine. The next day, he was tired from the night before. He had no symptoms the next day. After he took alprazolam, he slept fine, he felt better. The hot flashes, heart racing, body aches, and chills were gone, and he read everything as far as symptoms. The heart racing went away about 11 the next morning because he took alprazolam. The patient stated that he forgot to add one more, he had all the symptoms described as side effects, but he also had itching. He had very mild itching and was given cetirizine hydrochloride (ZYRTEC, lot number: OHE2723, expiry date: Feb2022, UPC: 4122053077), it was like 80% gone. Every now and again he has a little itch, but it was bothering him all night that first night. Currently, the patient felt pretty good. He has no symptoms other than the slight itch. He further stated that his second dose is on 04Feb2021. Out of all symptoms, the thing that freaked him out the most was the heart racing, he asked if he could take diphenhydramine hydrochloride (BENADRYL) before the shot. He has been on antidepressants for a while, he has a lot of anxiety, but the day he went in, he felt good, and didn't take alprazolam. He also asked if this have triggered all that heart racing stuff. He was seeking for information if there was anything to do to prepare him better, he knew you have to sit there for 15-20 minutes to see if there was a reaction. The outcome of the event headache and lightheadedness was recovered on 14Jan2021, unknown for blood pressure high and tiredness, recovering for itchy, and recovered on 15Jan2021 at 11 am for all other events.
62 2021-02-04 muscle spasms Muscle cramps in lower back area. Feels like Kidney area Cramps started on 1/31/2021. I called out o... Read more
Muscle cramps in lower back area. Feels like Kidney area Cramps started on 1/31/2021. I called out of work on 2/1/2021 Went to urgent care on 2/5/2021. I had blood work done
62 2021-02-07 numbness muscle weakness of both legs; exacerbation of the baseline numbness of many areas of my body; This i... Read more
muscle weakness of both legs; exacerbation of the baseline numbness of many areas of my body; This is a spontaneous report from a contactable consumer (patient himself). A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, left arm, on 14Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included multiple sclerosis. Concomitant medication included gabapentin, tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), oxybutynin and vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]). The patient previously took diphenhydramine hydrochloride (BENADRYL) and experienced 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 prior to vaccination. On 18Jan2021 at 11:00, the patient had muscle weakness of both legs to the extent that he could not stand. He had an exacerbation of the baseline numbness of many areas of his body. The event resulted in emergency room/department or urgent care visit and the patient was hospitalized for 2 days. The patient received intravenous antibiotics as treatment. The event was considered serious by the patient, requiring hospitalization. The patient's COVID test post vaccination via nasal swab on 18Jan2021 was negative then via blood test on 20Jan2021 was negative. The patient recovered from the events on an unspecified date. Information on the lot/batch number has been requested.
62 2021-02-07 pain in extremity Intense pain to R foot within 12 hours; This is a spontaneous report from a contactable other HCP (p... Read more
Intense pain to R foot within 12 hours; This is a spontaneous report from a contactable other HCP (patient). A 62-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), via an unspecified route of administration on 29Dec2020 10:30 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, type 2 diabetes mellitus, cerebrovascular accident, Penicillin allergy. The patient experienced intense pain to R foot within 12 hours on 30Dec2020 01:30 with outcome of recovered with sequelae. Treatment received for the adverse event included: MRI, Ultrasound, Interventional radiology. The patient was hospitalized for intense pain to R foot within 12 hours for 9 days. The patient underwent lab tests and procedures which included Interventional radiology, magnetic resonance imaging, Nasal Swab test: negative, ultrasound scan.; Sender's Comments: The 62-year-old male patient had medical history included hypertension, type 2 diabetes mellitus and cerebrovascular accident. The reported intense pain to R foot was more likely due to intercurrent condition/disease, and less likely causally related to the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information, including MRI and Ultrasound findings and Interventional radiology details, 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.
62 2021-02-08 muscle spasms, hot flush Muscle cramps through body, hot flashes, sore throat, and upset stomach.
62 2021-02-09 weakness muscle pain, weakness, fatigue-Possible GBS/AIDP Narrative:
62 2021-02-09 bell's palsy Bell's Palsy, received valacyclovir, prednisone in ED, now improved by 95%
62 2021-02-16 burning sensation Right chest, right shoulder, right shoulder blade pain, extreme to the point where i wasn't able sle... Read more
Right chest, right shoulder, right shoulder blade pain, extreme to the point where i wasn't able sleep and a burning sensation in those areas as well
62 2021-02-16 tremor About 30 minutes or so after injection, patient had reaction. The patient had really bad tremors, bl... Read more
About 30 minutes or so after injection, patient had reaction. The patient had really bad tremors, blood pressure was ok but pulse was fluctuating. Nurse was at bedside providing oxygen through mask. He was given aspirin and didn't need EpiPen. 911 was called and patient was transported
62 2021-02-17 tremor woke next morning w/ temp. 100.8 fever; full body aches; left armpit swollen / sore (inj. arm); left... Read more
woke next morning w/ temp. 100.8 fever; full body aches; left armpit swollen / sore (inj. arm); left armpit swollen / sore (inj. arm); extreme shaking last 2-3 hours; severe headache; eye ache; administration date of dose 1: 11Jan2021/ administration date of dose 2: 28Jan2021; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249 and expiration date not provided), via an unspecified route of administration left arm second dose on 28Jan2021 at single dose for Covid-19 immunization. The vaccine was administered in the hospital. The Patient's medical history included Esophageal Cancer. The patient's concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686 and expiration date not provided) via an unspecified route of administration left arm first dose on 11Jan2021 for Covid-19 immunization. On 28Jan2021 17:30, the patient experienced extreme shaking last 2-3 hours, severe headache, eye ache, full body aches, left armpit swollen/sore (injection arm). Woke next morning 29Jan2021 with temperature 100.8 fever, later evening, temperature of 99.6. Symptoms lasted almost 72 hours. The patient stayed in bed the entire time. The patient did not received treatment for the events. The outcome of the events was recovered. The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
62 2021-02-21 pain in extremity Patient had sore arm on the day of vaccination. Per patient's nephew , the next morning patient expe... Read more
Patient had sore arm on the day of vaccination. Per patient's nephew , the next morning patient experienced body pains, aches, headache . Onn Tuesday patient had fever. Patient's condition progressively got worse. He had difficulty breathing by Wednesday night. He had low oxygen levels at 80 per pulse ox reading. Patient was coughing up blood. Family took him to hospital on Thursday morning due to breathing difficulty and patient died 2.18.21 at 10 am
62 2021-02-22 pain in extremity severe chills. shivering at night for 2 hours. no fever, some aching and malaise. this was 4 days a... Read more
severe chills. shivering at night for 2 hours. no fever, some aching and malaise. this was 4 days after shot. all previous days was fatigued alittle chilled and arm sore. taking alot of tylenol drinking alot of water. things did not get worse.
62 2021-02-24 numbness Pt felt arm soreness 4 hours later than felt fatigued, leg heaviness, arm heaviness, and then felt f... Read more
Pt felt arm soreness 4 hours later than felt fatigued, leg heaviness, arm heaviness, and then felt faint with black spots in eyes and numbness down left extremity. Symptoms are still persisting 5 days later today 2/25/21. PT did not knowingly have COVID prior.
62 2021-02-28 weakness Headache, muscle ache, bone ache, upset stomach, lack of energy
62 2021-02-28 unresponsive to stimuli Patient remained at baseline until noted at 2130 unresponsive and abnormal VS. Sent to ED and patien... Read more
Patient remained at baseline until noted at 2130 unresponsive and abnormal VS. Sent to ED and patient passed away in ED
62 2021-03-02 sciatica sciatic nerve diagnosed as inflamed only left leg and shot provided left arm; This is a spontaneous ... Read more
sciatic nerve diagnosed as inflamed only left leg and shot provided left arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration in right arm on 08Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included blood pressure. Concomitant medication included unspecified blood pressure medication. On 09Jan2021 at 2pm, sciatic nerve was diagnosed as inflamed only on left leg and shot (treatment) was provided in left arm. Patient visited emergency room/department, methylprednisolone sodium succinate (PF) was given as treatment. The event was reported as non-serious, patient was not hospitalized. The patient underwent lab tests which included COVID-19 Nasal RT-PCR: negative on 25Jan2021 (Nasal Swab). Outcome of the event was recovering. Information on the lot/batch number has been requested.
62 2021-03-03 burning sensation, flushing Patient felt burning in left arm, and said he felt flushed approximately 15 minutes after receiving ... Read more
Patient felt burning in left arm, and said he felt flushed approximately 15 minutes after receiving 1st dose of the vaccine. Patient refused transport to nearby hospital. He waited an additional 10 minutes before leaving.
62 2021-03-04 weakness Broken bones; Fever 102.2; General weakness; Injection site pain; This is a spontaneous report from ... Read more
Broken bones; Fever 102.2; General weakness; Injection site pain; This is a spontaneous report from a contactable other health professional reported for himself. A 62-year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021 08:15 on Arm left at single dose (Lot # EL9267) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. He experienced Fever 102.2, broken bones, general weakness and injection site pain on 17Feb2021, which were non serious. Tylenol were received for the events. The patient had not been tested for COVID-19. Outcome of the events was recovered.; Sender's Comments: The event broken bones was considered as an intercurrent condition and unrelated to the use of 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.
62 2021-03-04 tingling, numbness, cold extremities Tingling in arm he received vaccine Numb finger tips Hand is colder in comparison to the other
62 2021-03-04 tingling Since the injection, I've had ongoing tingling and weakness in my arm. Unable to open a jar with my... Read more
Since the injection, I've had ongoing tingling and weakness in my arm. Unable to open a jar with my hands, which I could do previously. I feel a bit off and this has been going on since I received the shot 2 weeks ago. Concerned about getting the second dose, which is due 3/15 - I don't want these symptoms to worsen and need guidance.
62 2021-03-06 tremor Chills, shakes, 101 degree fever
62 2021-03-08 flushing Approximately 10 minutes after vaccine patient had c/o flushing for approximately 15 minutes.
62 2021-03-10 weakness, tremor After my vaccine, I went to the hospital because I experienced weakness some shortness of breath an... Read more
After my vaccine, I went to the hospital because I experienced weakness some shortness of breath and some tremors. I am a doctor of training, one aspect the aspect of covid-19 affects testosterone. I got Covid after my first dose. I am still having some symptoms and scheduled to return back to work the third week of March 2021.
62 2021-03-10 tingling, feeling hot, feeling cold Within 1 minute of vaccine being injected. I started to feel dizzy. I was wheeled in wheelchair to o... Read more
Within 1 minute of vaccine being injected. I started to feel dizzy. I was wheeled in wheelchair to observation area. I kept feeling more dizzy and started to feel tingly in my fingers and legs (both sides equally) After 15 minute observation time was over, I tried to stand up and immediately sat down again as a wave of dizziness hit me. Doctor in observation area saw me and came over. I told him how I felt. He put his fingers to my wrist and felt my pulse. It was initially between 40 and 90, then steadied off around 90-100. He called for EMTs on duty to come over with a stretcher because he thought I should be laid flat. The EMT took my blood pressure and it was 155/94. The doctor said at one point my pulse was thready. By this point the dizziness was stronger and I felt tingly in my teeth as well as other areas. I was asked about my breathing and I said that it was okay. An ambulance was called for and arrived. I don't remember the exact time. The moved me from the wheelchair to a stretcher. I could not stand up on my own and lurched toward the stretcher. I am grateful strong people were there to get me on stretcher and strapped in. All throughout this my normally barely noticeable Atrial Fibrillation was quite apparent and more erratic. This was a major reason for ambulance call. Some of the stroke protocol was done including gripping EMT's fingers equally and following his finger with my eyes. I was very cold throughout. I was brought to the waiting ambulance outside and driven to Medical Center. The EMT took an EKG which showed atrial fibrillation and a line was put into my arm. When we got to the hospital, I was brought into the triage area and had all my vitals taken. Blood pressure was high, so was pulse then for a half hour, I was very hot and sweated a lot after being cold.
62 2021-03-11 migraine 12 hours after the second Covid 19 injection I got a severe debilitating migraine with chills. The m... Read more
12 hours after the second Covid 19 injection I got a severe debilitating migraine with chills. The migraine was the worst I have ever had in my life. It lasted for 10 hours. I have had migraine throughout my life but nothing this severe. I took Tylenol and used cold compress on my forehead.
62 2021-03-11 unresponsive to stimuli 62 yo M with no known medical history awoke 12:15 am on 3/11/2021 and told his wife he had "pain all... Read more
62 yo M with no known medical history awoke 12:15 am on 3/11/2021 and told his wife he had "pain all over". When she asked if it was chest pain, he said he didn't know. He went downstairs, vomited, slumped over against the wall behind the couch, and became unresponsive. Wife called 911 and was instructed to begin CPR. EMS crew arrived shortly after that and performed prolonged resuscitation efforts as per ACLS protocol. Pt pronounced at 3:15 am. Patient had not seen a physician in many years, had not had any vaccines in over 20 years, took no medications, and had no known medical history. He did have a strong family history of heart disease and had told his wife the week prior to his death that he had suffered a several-hour bout of chest pain that resolved spontaneously 2-3 days prior to his telling her about it. He refused to seek medical evaluation despite her urging.
62 2021-03-12 tingling Dizzy tingling in legs
62 2021-03-13 feeling hot, weakness he was excited and/or anxious about getting vax after having Covid in November. vax dose approx 305 ... Read more
he was excited and/or anxious about getting vax after having Covid in November. vax dose approx 305 pm, by 310 he reported feeling weak with rapid pulse and heart fluttering. Gave water to drink, he declined food. 315 he felt hot sweaty and took off his overcoat. 325 said he felt better after drinking the water and declined to have his bp or pulse checked. Follow up phone call 3/14 to check on condition, said he felt ok after leaving pharmacy and has no allergies, no current illnesses and no vaccines within past month.
62 2021-03-13 pain in extremity Day 1 (evening): soreness in arm radiating to back and neck, accompanied by waves of light nausea, r... Read more
Day 1 (evening): soreness in arm radiating to back and neck, accompanied by waves of light nausea, resolved itself after about two hours. Low-grade headache continued to bedtime w/no appetite. Day 2: Low grade headache and lightheadedness. Light nausea only after eating. Resolved by dinner. Day 3: Some lingering fatigue, but symptoms mostly resolved.
62 2021-03-14 flushing Several minutes after vaccine administration, patient was flushed and diaphoretic. No shortness of ... Read more
Several minutes after vaccine administration, patient was flushed and diaphoretic. No shortness of breath, No chest pain. No dizziness. Has history or DM and HTN. Denied nausea. PCP had changed his DM medication and he took the new prescription this morning. Felt better after 22 minutes and discharged home.
62 2021-03-14 tremor Bad chills and shaking followed by extreme headache. Lasted 24 hours and then gone..
62 2021-03-17 facial pain, inability to speak Left side of face pain and swelling, under jaw and ear pain, tongue pain. Difficulty swallowing and... Read more
Left side of face pain and swelling, under jaw and ear pain, tongue pain. Difficulty swallowing and speaking. This continues after four days!
62 2021-03-17 numbness, feeling hot, tingling Left side of face from cheekbone to chin feeling like novacane wearing off - warm, tingly, slightly... Read more
Left side of face from cheekbone to chin feeling like novacane wearing off - warm, tingly, slightly numb.
62 2021-03-19 weakness Difficulty breathing, throat swelling (feels like it is) dizziness and weakness, nausea, feeling unw... Read more
Difficulty breathing, throat swelling (feels like it is) dizziness and weakness, nausea, feeling unwell, fever headache, tiredness and injection site pain
62 2021-03-21 speech disorder Exacerbation of Parkinson?s symptoms, trouble walking, speaking, mental slowness, worsening balance
62 2021-03-24 facial paralysis, bell's palsy Severe grade v, Bell?s palsy on left face. Started 3days after second covid-19 vaccine. Patient has... Read more
Severe grade v, Bell?s palsy on left face. Started 3days after second covid-19 vaccine. Patient has history of Bell?s palsy on the same side about 10years ago but had near full resolution with only mild facial asymmetry and eye lid droop prior to this. Patient sought care in our ER 3/24 and I did a video call with him 3/25 confirming severe left facial droop and inability to raise left eye brow or close eye, consistent with house-Brockman v Prednisone/valacyclovir initiated
62 2021-03-24 pain in extremity Right arm shoulder and elbow pain
62 2021-03-25 weakness, mild one side paralysis Per report from patient's daughter: Patient received 1st dose of Pfizer around 4:30 pm on 2/7/21. Ar... Read more
Per report from patient's daughter: Patient received 1st dose of Pfizer around 4:30 pm on 2/7/21. Around 4 am the next morning, 2/8/21, he woke up and didn't feel good. Around 12 pm on 2/8/21 he reported feeling "weak" especially on one side of his body. His daughter said she took him to the hospital around 9:30 pm that night, after he continued to feel unwell throughout the day. At Hospital he was diagnosed as having had a stroke. He was admitted to the hospital and kept for observation for 2 days. When his daughter reached out to the patient's PCP to ask if he should get the 2nd Pfizer dose, she was told he should wait at least 3 months and advised to report his stroke to the public health department.
62 2021-03-25 cold sweat Cold sweats 64.5 hours later, causing fainting, followed by vomiting 6 times and diarrhea once. Rec... Read more
Cold sweats 64.5 hours later, causing fainting, followed by vomiting 6 times and diarrhea once. Recovered after 1 hour.
62 2021-03-26 flushing, tremor Mild dull headache began about 18 hours post-vax. Unresponsive to OTC pain relief. About 5 hour... Read more
Mild dull headache began about 18 hours post-vax. Unresponsive to OTC pain relief. About 5 hours later, there was an episode of chills, accompanied by severe shaking. Face and neck became very warm and flushed. After about an hour, the episode ended, and even the long-lasting headache felt better. Have not had any adverse effects that were not known to be occurring in some after the 2nd Pfizer vax.
62 2021-03-26 tingling Patient reported feeling a "prickly" feeling on his chest and left arm. Patient said "it feels like ... Read more
Patient reported feeling a "prickly" feeling on his chest and left arm. Patient said "it feels like I fell into a cactus." Patient also reports his face itching. Denies any other symptoms. No bumps or redness observed. After 10 minutes, the symptoms subsided. Instructed patient to call PCP for new or worsening symptoms.
62 2021-03-28 pain in extremity Patient experienced severe arm pain in his shoulder at 8:00am. Blood pressure at 8:00am was 151/80 (... Read more
Patient experienced severe arm pain in his shoulder at 8:00am. Blood pressure at 8:00am was 151/80 (normal for patient) and heart rate was 79 beats per minute. At 8:15am pain was radiating down the patient's arm. At 8:40am the patient was feeling better and felt comfortable leaving with his wife because she is a nurse
62 2021-03-28 pain in extremity Extreme intense muscle pain to shot area, left arm, left shoulder around back to the right shoulder.... Read more
Extreme intense muscle pain to shot area, left arm, left shoulder around back to the right shoulder. started on 6th day with max pain on 8th/9th day. pain subsiding on day 10. treated with Advil/Acetaminophen Dual-Action and lidocaine medicated rub.
62 2021-03-29 facial paralysis, numbness and pain in extremities Right facial droop worsening neuropathy
62 2021-03-29 pain in extremity A few minutes after receiving the vaccine felt tongue "thickness" but only lasted about a minute. Th... Read more
A few minutes after receiving the vaccine felt tongue "thickness" but only lasted about a minute. Then about 4 hrs later felt headache, dry throat and sore arm. At about 7 hrs after injection noticed pain in the left wrist, same side as vaccine. Went to bed and all symtoms were resolved this morning except sore arm.
62 2021-03-30 weakness 1. First shot, no adverse effect. 2. After the second shot I developed chills, aches and a very slig... Read more
1. First shot, no adverse effect. 2. After the second shot I developed chills, aches and a very slight fever within four to five hours of the shot. Later that night I noticed a decided lack of energy and some arm soreness at the shot site when I touched it. The chills and fever subsided after about two to three hours, but the rest of the symptoms continued until I fell asleep around midnight, which was about 12 hours after getting the shot. The aches, arm soreness and weakness all lasted for about a week afterwards, with the weakness being the last thing to go.
62 2021-03-30 tenderness Pt. has a swollen spot under his left arm pit the size of a small apple, and it is sore to touch, an... Read more
Pt. has a swollen spot under his left arm pit the size of a small apple, and it is sore to touch, and feels like an achy muscle. This was noticeable after the second injection of the Pfizer vaccine.
62 2021-03-31 numbness Left arm, left eye/face numbness (front teeth and cheek numb) and some lightheadedness. Vitals: 02 s... Read more
Left arm, left eye/face numbness (front teeth and cheek numb) and some lightheadedness. Vitals: 02 sat 98% on RA, BP 122/70, HR 60. No rash, itchiness or wheezing. Throat/neck/thorax clear. Patient given 25 mg PO Benadryl and 20 mg PO famotidine.
62 2021-03-31 unresponsive to stimuli Shortly after receiving vaccine, participant's wife summoned nurse, found him sitting in car with ey... Read more
Shortly after receiving vaccine, participant's wife summoned nurse, found him sitting in car with eyes open, but unresponsive. After approx. 30 sec. he was responding to questions; c/o feeling light headed, nauseated and had 'limited' vision. B/P 110/74, O2 sat 87%, HR 51. EMS arrived and assessed participant. Repeat B/P160/102 and BG 118. Due to cardiac hx., participant agreed to be transported to E.D. On 4/1/21 made a f/u phone call to participant and he stated that lab work in the E.D. indicated that he was anemic.
62 2021-04-01 bell's palsy Bell's Palsy; stroke; Minor injection site soreness; Extreme sleepiness (2 days); This is a spontane... Read more
Bell's Palsy; stroke; Minor injection site soreness; Extreme sleepiness (2 days); This is a spontaneous report received from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206), first dose via an unspecified route of administration, administered in right arm on 05Mar2021 07:30 as single dose for covid-19 immunisation. Medical history included high blood pressure (HBP) hypertension, Transient ischaemic attack (TIA) twice, pre-diabetic. Known allergies was none. Concomitant medications received within 2 weeks of vaccination included metformin, atorvastatin, losartan, amlodipine, Aspirin (acetylsalicylic acid). The most recent COVID-19 vaccine was administered at work location. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced bell's palsy (17 days after vaccination - confirmed via ER visit vice stroke) and stroke (seriousness crietria was medically significant), minor injection site soreness (2days) and extreme sleepiness (2 days); all events on 22Mar2021 17:30. The adverse event result in emergency room/department or urgent care. Treatment was received for all adverse events including Steroid/anti-viral medication 7 days by neurologist. The event outcome for all events was not recovered. Follow-up attempts are needed. Information on batch/lot number was available.
62 2021-04-01 flushing PT (DOB 12/14/1958) received the COVID vaccine (Pfizer dose 1, Lot# EW0150, exp 7/31/2021) at 1525.... Read more
PT (DOB 12/14/1958) received the COVID vaccine (Pfizer dose 1, Lot# EW0150, exp 7/31/2021) at 1525. The client reported feeling dizzy and lightheaded, and his caregiver reported that he was "red and sweaty". EMT alerted the RNs and responded to the client. Upon observation, the EMT observed that the client appeared flushed and diaphoretic. The client was accompanied by his caregiver who reported that the client has a medical history of hypertension, orthostatic hypotension, intellectual disability, schizophrenia, diabetes mellitus 2, and bell's palsy. The client has no allergies and takes the following medications: metformin, lipitor. clozapam, metoprolol, cogentin, iron, prostigmine, and farxiga. At 1530, the EMT obtained a blood pressure of 180/118, with a heart rate of 116, respiratory rate of 22, temperature of 99.1 F and pulse oximeter reading of 94%. At 1536, the client's blood pressure was 172/118, with a heart rate of 116, respiratory rate of 20, and pulse oximeter reading of 95%. At this time, the client stated that he was dizzy and feeling anxious. The client reported that he was feeling dizzy before he was vaccinated but that he "forgot" to tell his caregiver. His caregiver reported that the client had not yet eaten or had anything to drink that day. The client was offered and accepted water. The client and his caregiver deferred Benadryl. Repeat vital signs were obtained at 1542: blood pressure of 166/112, heart rate of 116, respiratory rate of 24, temperature of 99.1 F, and a pulse oximeter reading of 95%. The client practiced deep breathing, denied any difficulty breathing, itching or swelling. At 1550, the client reported no longer feeling anxious or dizzy. At this time, the client's color was improved, he no longer was diaphoretic, and he stated "I'm pretty hungry now." Repeat vital signs were as follows: 156/115, heart rate 108, respiratory rate 20, and pulse oximeter reading of 95%. Client left the facility at 1600 after waiting the recommended 30 minutes from initial symptoms, with symptoms resolved at that time. The client ambulated to his car with a steady gait, escorted by the EMT and his caregiver, and his caregiver drove him home.
62 2021-04-01 pain in extremity leg pain, left side of his body; swelling to his left arm; swollen lymph nodes, swollen neck lyphnod... Read more
leg pain, left side of his body; swelling to his left arm; swollen lymph nodes, swollen neck lyphnodes to the left side of his neck; inabilitly to move his jaw accompanied by severe pain; inabilitly to move his jaw accompanied by severe pain; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from another company (manufacturer control number: US-AMGEN-USASL2021043173), license party for etanercept (ENBREL). This non-serious solicited report (USASL2021043173) was reported to a company on 18/MAR/2021 by a consumer from a commercial program (PSP00086) and involves a 63 year old male patient who experienced leg pain, left side of his body [PT: pain in extremity], swelling to his left arm [PT: peripheral swelling], swollen lymph nodes, swollen neck lyphnodes to the left side of his neck [PT: lymphadenopathy], inabilitly to move his jaw accompanied by severe pain [PT: jaw disorder], inabilitly to move his jaw accompanied by severe pain [PT: pain in jaw] while receiving Enbrel, Reusable Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel, Reusable Autoinjector on an unknown date. On 22/FEB/2021, the patient took his previous injection to recent last dose. At that point patient's Enbrel was put on hold for getting first Covid (coronavirus disease) vaccine. On 02/MAR/2021, the patient was administered first Covid (coronavirus disease) vaccine. On 12/MAR/2021, the patient restarted Enbrel. On 13/MAR/2021, the patient woke with swollen lymph nodes, leg pain which was right below the knee and had inability to move his jaw which was accompanied by severe pain. The patient reported all the pain was located on the left side of his body. The patient also had swelling to his left arm. The patient reported that he was seen and treated in the emergency room and all reported symptoms resolved post unspecified treatment. On 18/MAR/2021, the patient developed swollen on neck lymph nodes to the left side of his neck. The outcome of the event lymphadenopathy was reported as not recovered/not resolved. The outcome of the events pain in extremity, peripheral swelling, jaw disorder, pain in jaw were reported as recovered/resolved. The events pain in extremity, peripheral swelling, jaw disorder, pain in jaw were resolved on an unknown date in MAR/2021. Action taken with Enbrel was reported as unknown for the events pain in extremity, peripheral swelling, lymphadenopathy, jaw disorder and pain in jaw. Action taken with Reusable Autoinjector was reported as unknown for the events pain in extremity, peripheral swelling, lymphadenopathy, jaw disorder and pain in jaw. The causal relationship between the events pain in extremity, peripheral swelling, lymphadenopathy, jaw disorder, pain in jaw and Enbrel was not provided by the consumer. The causal relationship between the events pain in extremity, peripheral swelling, lymphadenopathy, jaw disorder, pain in jaw and Reusable Autoinjector was not provided by the consumer. Follow up has been requested. The reporter's assessment of the causal relationship of the events with the suspect product etanercept was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment. Company's Causality Assessment: The events Leg pain, Swelling arm, Lymph nodes enlarged, Jaw disorder, Pain in jaw were considered as non-serious and related to etanercept.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drugs to the reported events "leg pain, left side of his body", "swelling to his left arm", "swollen lymph nodes, swollen neck lyphnodes to the left side of his neck" and "inabilitly to move his jaw accompanied by severe pain" cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
62 2021-04-01 pain in extremity sore muscles. arthritis flare up Gout in my foot swelled up like a balloon (extremely painful). all ... Read more
sore muscles. arthritis flare up Gout in my foot swelled up like a balloon (extremely painful). all symptoms are receding as of 4/2/2021 8:30
62 2021-04-01 tingling Rash on back, abdomen, bilateral arms and stingling/tingling sensation
62 2021-04-01 tremor I began shaking violently and severe cold chills. I began hallucinating and felt like I was turning ... Read more
I began shaking violently and severe cold chills. I began hallucinating and felt like I was turning inside out. I blacked out and woke 2 hours later with severe flu like pain in my entire body and a severe headache. I do not do drugs and I had no alcohol in the 3 days before I wa vaccinated. It is now 47 hours after the vaccination and I have moderate flu like symptoms.
62 2021-04-02 pain in extremity Stiff arm, shoulder and neck. Sore arm, shoulder and neck. Severe chills. Couldn?t turn my head to t... Read more
Stiff arm, shoulder and neck. Sore arm, shoulder and neck. Severe chills. Couldn?t turn my head to the left and couldn?t raise my arm. Had both shots in the left arm. Still have slight pain in those areas.
62 2021-04-03 nerve pain 1. Ringing in both ears. Note: I have had very mild tinnitus for the past 20 years that comes and go... Read more
1. Ringing in both ears. Note: I have had very mild tinnitus for the past 20 years that comes and goes, but after receiving the vaccine, the sound became louder and as of this writing it has not stopped in both ears since 11:15, 31 March, 2021 2. Fiery nerve pain thought my entire body that reached pain levels of 8-9 that I have not experienced since 2016. Note: I have been diagnosed with Immune-Mediated-Neuropathy since 2016. Prior to the vaccine, I had pain levels 1-3, and only on parts of my body at times; mainly legs. However, about 45 minutes after the vaccine, my entire body lite up with fiery nerve pain thought my entire body.
62 2021-04-03 pain in extremity This is a spontaneous report from a contactable consumer. A 62-year-old male consumer (patient) rece... Read more
This is a spontaneous report from a contactable consumer. A 62-year-old male consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3302, Expiration date: unknown) via an unspecified route of administration in left arm on 26Jan2021 at 14:30 at single dose for COVID-19 Immunization. The patient medical history and family history were none. No prior vaccinations within 4 Weeks. Current condition included, hypochondriac. History Of All Previous Immunizations was Not provided. Additional Vaccines Administered On Same Date Of Pfizer Suspect was reported as no. Concomitant conditions were not reported. On 27Jan2021 patient experienced sore arm, "more pronounced than normal flu shot" On 28Jan2021 patient experienced the events, "nose starting dripping/running", "eyes dry", "dry hacking cough". "sinuses swollen a little bit" the patient said that symptoms were similar to "cold symptoms" and still experiencing nasal drainage and "tickle in throat", "eyes dried out", Paranasal sinus discomfort. Nose dripping stopped after about a week and turned more into sinus pressure. Patient underwent lab test Swab COVID test on 01feb2021, results negative on 02Feb2021. No other testing since the COVID-19 Vaccine. His eyes are dried out and it feels like a cold that progresses into different stages. Arm soreness: lasted two day. More pronounced than flu shots he's received. Lasted through 28Jan2021. Tickle in throat with cough: Has a little tiny bit of irritation still. Not a constant cough. Is talking now and feels like he wants to cough, but doesn't. Nose is not dripping as much. Never been totally stopped up. Feels pressure underneath eyes. Adverse Events did not require Require A Visit To: no, it is just mild, but weird. Relevant Tests included Swab COVID test on 01Feb2021. Negative results came back on 02Feb2021. No other testing since the COVID-19 Vaccine. The patient did not received any treatment for these symptoms. Product Complaint was Yes. Not provided, if a sample of the product available to be returned. No information provided whether product Packaging sealed and intact. Outcome for all events were reported as unknown. No follow-up attempts are possible. No further information is expected.
62 2021-04-03 pain in extremity severe headache, muscle aches, fatigue, sore arm, lack of appetite, weight loss, trouble focusing
62 2021-04-04 feeling cold 8 hours after vaccine terrible chills, and cold, stomach ache 12 hours after vaccine had 104.7 temp.... Read more
8 hours after vaccine terrible chills, and cold, stomach ache 12 hours after vaccine had 104.7 temp. 24 hours still was dealing with 104.7 temp - showers and cold compress with tylenol would bring it down, but would spike back up 36 hours temp of 101
62 2021-04-06 discomfort, pain in extremity After 17 hours: Uncontrollable chills, though temperature was only slightly elevated at 99 degrees. ... Read more
After 17 hours: Uncontrollable chills, though temperature was only slightly elevated at 99 degrees. Malaise lasted 10 hours. Pain at arm lasted 40 hours. Slight pain with pressure continues now. (about 60 hours)
62 2021-04-06 pain in extremity extreme fatigue, headache, arm soreness, and chills
62 2021-04-06 pain in extremity bulging eyes; Mild allergic reaction; metallic taste in mouth; pounding headache; red ears; face/nec... Read more
bulging eyes; Mild allergic reaction; metallic taste in mouth; pounding headache; red ears; face/neck rash; fatigue; dizzy.; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on 23Mar2021 12:00 (Batch/Lot number was not reported), at the age of 62-years at vaccination, as SINGLE DOSE for COVID-19 immunization. Medical history included enlarged aorta, high blood pressure, asthma, eggs and corn allergy. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported; budesonide (PULMICORT) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin, ferrous sulfate, folic acid, serine (RESCUE) taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 12:00, the patient experienced mild allergic reaction, started with metallic taste in mouth and pounding headache before leaving (pharmacy name withheld) after 15 min wait period, red ears, face/neck rash, "bulging eyes". No respiratory issues. Subsided after <1 hour but still feeling fatigue and dizzy. The patient also had sore arm. Still thrilled to get it. The outcome of the events was recovering. No treatment was received for the events. Information on the lot/batch number has been requested.
62 2021-04-08 bell's palsy, facial paralysis approximately 10 days post vaccine shot, onset of headaches and tiredness for two days. On the 12th ... Read more
approximately 10 days post vaccine shot, onset of headaches and tiredness for two days. On the 12th day, I ended up with facial droop and being rushed to the emergency room. Ct. scan and subsequent mri ruled out a stroke and diagnosis after spending two days at hospital was Bells Palsey.
62 2021-04-08 tremor, feeling hot, weakness Patient seen at the Vaccination Center on 4/9/2021. He had just received his first dose of COVID-1... Read more
Patient seen at the Vaccination Center on 4/9/2021. He had just received his first dose of COVID-19 vaccine. He was feeling dizzy and felt like he was going to pass out. He was transported by EMT to the Adverse Reaction Area and then moved. Representative served as sign language interpreter via tablet. His wife was also present and is deaf. Patient stated that his heart rate was very slow, and he felt dizzy, hot, and sweating. He also fel very weak and it appeared that was going to pass out. He was also shaking. Ambulance was called due to the above symptoms. Patient also stated that he thought he may need to go to the ER. Vital signs: 9:53 am: Blood pressure was 143/71, heart rate was 71. Patient was given an ice pack. He also took sips of water. He then noted that he felt better, after laying down. Ambulance crew arrived and he declined to go the ER. He got up and walked around stated the he felt better. He notes that his head feels like it's slightly buzzing, so he lay down again. Vitals signs: 10:25 am: Blood pressure 138/63, heart rate is 64, temperature is 98.1 Patient felt better and noted no more buzzing in his head. He also walked around and felt normal. Patient notes that he blacked out as a child whenever he got shots/injections. He was not surprised that this happened to him today. He wanted to know whether he should get the second vaccine injection. It is recommended that he get his second vaccine injection and we also discussed that he may have the same reaction as today. He should allow for extra time and be well-hydrated. He felt safe to go home and his wife would be driving him home. Should he feel worse, then he should go to the ER. The patient and his wife understand this. All questions were answered.
62 2021-04-09 pain in extremity Adverse effect with the onset of gout 24 hours extremely painful in the right foot.
62 2021-04-11 bell's palsy 2nd Pfizer COVID-19 vaccine on 4/1/2021. Developed Bell's palsy on 4/11/2021.
62 2021-04-11 numbness Numbness in tongue, mouth, lips, cheeks, face lasting approx 2hrs and 30 minutes
62 2021-04-11 numbness Continued soreness in injection arm every day since first injection. Near-continuous cognitive befu... Read more
Continued soreness in injection arm every day since first injection. Near-continuous cognitive befuddlement / inability to think clearly - only have had this before with severe sinus infection / head cold (I'm a practicing degree'ed engineer - very scary to me). Had a bout of "double vision" for approximately a minute - never had this before - another very scary thing. Two days ago experienced "highway hypnosis" - zoned out while driving for 10 minutes - lost time event / can't remember driving the route I did - never had this before - another very scary thing.
62 2021-04-13 bell's palsy Bells palsy
62 2021-04-13 numbness Numbness in face and right thigh
62 2021-04-13 numbness Played tennis on Sun 4/11 (entire left leg felt numb; didn't fully support my weight) Played tennis... Read more
Played tennis on Sun 4/11 (entire left leg felt numb; didn't fully support my weight) Played tennis on Tue 4/13 (had diarrhea beforehand; left calf throbbed and then "popped"; had to stop immediately) Overnight Tue/Wed upset stomach
62 2021-04-13 tingling, pain in extremity About 1 day after vaccination, there was pain in the muscles around the right hip joint to the exten... Read more
About 1 day after vaccination, there was pain in the muscles around the right hip joint to the extent that I had difficulty walking up the staircase. It lasted for 2+ days and gradually diminished. Then, sporadic pains appeared in the right collar bone for a day, then in the left collar bone for a day or 2; and then intermittent ache in the left elbow and left hand; and then soreness in finger joints of both hands, especially in the morning; and, beginning 5 days ago and ongoing, RA-type pain is felt in the left shoulder, especially when I try to lift the arm or holding something with the left arm stretching out. this pain seems to be growing. Sometimes, tingling sensation in the toes and soles of both feet.
62 2021-04-14 feeling hot chills dry heeve sweats diahrea tiredness (extreme) hot/ no fever
62 2021-04-15 migraine, weakness Patient started having decreased urine output, painful urination, and dark brown urine 5 days after ... Read more
Patient started having decreased urine output, painful urination, and dark brown urine 5 days after receiving his first Pfizer COVID vaccine. These symptoms were accompanied by migraine and nausea. UA on 4/13 consistent with a UTI and started on Bactrim. On 4/14 he started having chills and weakness with kidney pain on the left side. CT abdomen and pelvis on 4/14 showed a left kidney calyceal diverticula with calcification in the superior pole that could have been a nidus for infection with symptoms showing 5 days after COVID vaccine. Increased suspicion for pyelonephritis and antibiotic changed to Macrobid. After a few days of increased hydration and antibiotics, urinary symptoms improved. Will continue monitoring kidney infection. Still had flu-like symptoms as of 4/15. Heart rate was first recorded on 4/13 at 113 and again on 4/16 at 111. Patient stated it had been elevated all week. Left lower lobe had decreased breath sounds. Working up for possible PE.
62 2021-04-15 pain in extremity My Dad was healthy no symptoms on first shot . On Second shoot just slight pain in arm , he felt si... Read more
My Dad was healthy no symptoms on first shot . On Second shoot just slight pain in arm , he felt sick on Sunday the 4 of April at around 7pm he had a upset stomach. He got worse at night. in the morning Monday the 5 April we decided it was time to take him to the hospital. Due to the covid 19 restriction we were not able to go in with him He was stable until 1 pm when he suffered 4 heart attacks . He Died . He was healthy he exercise and was active every day . We were told to report this because it was close to dates of vaccination.
62 2021-04-16 weakness Patient received 2nd dose of Pfizer Vaccine today at 2:32pm at temprorary vaccination Site Patient s... Read more
Patient received 2nd dose of Pfizer Vaccine today at 2:32pm at temprorary vaccination Site Patient started C/O SOB, Abominal Pain, and Weakness. Patient states that the SOB and abdominal pain were experienced prior to vaccinations but got worse. Patient shared medical history of CHF, DM and Hypertension. Patient requested to be transported to the nearest ER. 911 Called by writer. Pulse Ox 98%, RR 20, BP 130/80. Temp WNL. Patient alert and responsive oriented x3. Patient Transported to ER.
62 2021-04-16 numbness, facial paralysis Stroke symptoms (numbness on left hand, then developed into loss of control of left hand and left le... Read more
Stroke symptoms (numbness on left hand, then developed into loss of control of left hand and left leg, and also drooping of left side of face) showed up about three weeks after 1st dose of Pfizer COVID19 vaccine, and stroke occurred on 04/12/21 which is two days after the 2nd dose of Pfizer COVID19 vaccine.
62 2021-04-17 pain in extremity Calf soreness; stiffness; This is a spontaneous report from a contactable consumer. A 62-year-old ma... Read more
Calf soreness; stiffness; This is a spontaneous report from a contactable consumer. A 62-year-old male consumer reported for himself that: A 62-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in Arm Right on 18Mar2021 01:30 as SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity; drug hypersensitivity the patient's concomitant medications were not reported. The patient experienced calf soreness and stiffness on 28Mar2021 and the events were assessed as Non serious by health authority. and outcome of the events was Not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
62 2021-04-17 pain in extremity Sore arm later in day of injection; Slight fever; Slight fatigue; This is a spontaneous report from ... Read more
Sore arm later in day of injection; Slight fever; Slight fatigue; This is a spontaneous report from a contactable consumer(patient).This 62-year old male consumer(patient) reported for himself that: A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6199), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 09:45 as SINGLE DOSE, via an unspecified route of administration, administered in Arm Left on an unspecified date as an unspecified dose for covid-19 immunisation. Medical history included hypertension hypertension controlled with lisinopril, Allergic to penicillin. Concomitant medications included lisinopril taken for hypertension, the patient experienced sore arm later in day of injection, slight fever, slight fatigue on 30Mar2021 and The events were assessed as serious (medically significant) by health authority.outcome of the events was recovered. No follow-up attempts are needed. No further information is expected.
62 2021-04-19 pain in extremity Continued pain on the left arm.
62 2021-04-20 weakness The next morning after first shot Patient stood up and fell. Due to brain stem stroke there are bala... Read more
The next morning after first shot Patient stood up and fell. Due to brain stem stroke there are balance issues. Patient fell twice within first week of shot. He was extremely weak/unstable. He was starting to walk without his cane or walker. He could no longer walk on his own. He refused to talk because he was drooling all the time. There was little to no drooling before first shot. All the progress he made in the last 6 months is gone. He is just starting to feel like himself. Patient's second Pfizer shot was cancelled and will not be rescheduled.
62 2021-04-21 weakness Nausea, vomiting, weakness, syncope, dizziness, bradycardia
62 2021-04-21 pain in extremity Lymph node swelling in Right Shoulder and axillary regions including edema and increased skin temper... Read more
Lymph node swelling in Right Shoulder and axillary regions including edema and increased skin temperature/redness extending from axilla into Right pectoral region with pain/discomfort also. Performed gentle lymph drainage massage to Right trunk/shoulder regions and added Lymph Tone II homeopathic drops 3 times daily, with resulting dissipation of fluid in the pec region and decreased soreness.
62 2021-04-21 unresponsive to stimuli The patient passed out while sitting in the waiting area about 15 minutes after the vaccine was give... Read more
The patient passed out while sitting in the waiting area about 15 minutes after the vaccine was given. They were pale but became responsive very quickly after the fall. After about 20 more minutes the patient was able to stand up and felt "all better". The paramedics were called and assessed the patient before the patient left.
62 2021-04-22 muscle twitching, muscle spasms Intense muscle twitching in my lower extremities, especially in the feet and calf muscles of both le... Read more
Intense muscle twitching in my lower extremities, especially in the feet and calf muscles of both legs. Abodominal muscle spasms were present but not as prevalent or obnoxious as my legs. Also twitching in my right deltoids, triceps and thumb muscle. Could not sleep for two days . I began to get a headache due to no sleep so I took two 200 mg Advil tablets. I was able to sleep that night because the twitches had greatly subsided. I still have frequent but light twitches .
62 2021-04-22 pain in extremity Initially, the first day as with the first dose, my left arm ached but this time it lingered for abo... Read more
Initially, the first day as with the first dose, my left arm ached but this time it lingered for about 4 days. I was working a job that requires heavy lifting and at first thought it was the work, but after not working at all for about 3 days, my body would start aching all over. This is approximately 10 days after my second dose of Phizer. My bones ached, sort of like getting the flu. Late in the afternoons is when this pain would begin and by 7-8 at night, all I wanted to do was sleep. Each day, when waking most all the aching would be gone only to start up again about the same time in the afternoon/early evening. Last night, I went to bed about 7 pm and slept up until 6 am. As I am writing this, the aching is beginning in my arms again and I have tons of tiredness. It is 4:25 pm. and day 12 after the 2nd dose of Phizer.
62 2021-04-22 paralysis, severe one side paralysis, speech disorder March 15th COVID shot. March 16th started to get severe dizziness and fatigue. Went to bed early. ... Read more
March 15th COVID shot. March 16th started to get severe dizziness and fatigue. Went to bed early. March 17th speech was impaired and difficulty with gait and balance. Admitted to MAMC ER, which confirmed a stroke and released. March 18th early AM admitted again to ER due to unable to move/walk. Due to lacking proper equipment and space was transferred via ambulance to hospital in March 18th until March 24 Obeservations Inpatient at Hospital. March 24 to April 16th Inpatient rehab.
62 2021-04-23 pain in extremity Fever, chills and nausea 12 hours; fever and chills for an additional 20 hours. Immediately followin... Read more
Fever, chills and nausea 12 hours; fever and chills for an additional 20 hours. Immediately following the subsiding of fever and chills, I had extreme pain in my left hand (same arm as the shot was given). No swelling in my hand but my hand aches all over. I have very little strength in and use of my hand. I feel like my hand is broken. I have been experiencing the left-hand pain from the wrist down for approximately 12 hours now with no relief as of yet.
62 2021-04-23 pain in extremity Fatigue. Onset a few hours after the second shot and lasted about 36 hours. The fatigue was simila... Read more
Fatigue. Onset a few hours after the second shot and lasted about 36 hours. The fatigue was similar to that experienced when I had covid19 in March of 2020, but not as intense. Other information After the first shot I only experienced arm soreness in the arm that was injected. I was donating antibodies to the through about September/October 2020. I stopped donating for personal reasons, .
62 2021-04-23 pain in extremity The first Pfizer shot was on 4-1-21, and I had no reactions to that. The second Pfizer shot was on ... Read more
The first Pfizer shot was on 4-1-21, and I had no reactions to that. The second Pfizer shot was on 4-22-21, and a few hours after, I started feeling soreness in my arms, shoulder, neck, armpits and had chills (although no fever). Throughout the next couple of days, the chills and body aches went diminished and/or went away--except for my left armpit. My left armpit is still sore and it is swollen (now at 52 hours).
62 2021-04-24 pain in extremity Sore arm, slight fever, body aches
62 2021-04-24 pain in extremity Low grade fever (~100), chills, headache, nausea, muscle aches, feeling of fatigue and sore arm. Sym... Read more
Low grade fever (~100), chills, headache, nausea, muscle aches, feeling of fatigue and sore arm. Symptoms lasted about 24 hours.
62 2021-04-24 tenderness Tenderness in left shoulder after first dose; This is a spontaneous report received from a contactab... Read more
Tenderness in left shoulder after first dose; This is a spontaneous report received from a contactable consumer (patient, self -reported). This 62-years-old male patient received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8727 and expiry date: Jul2021) via Intramuscular route, into left upper arm in the muscle, on 22Mar2021, at 13: 15 (at the age of 62-year-old), as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 23Mar2021 at 02:00, the patient experienced tenderness in left shoulder after first dose. Outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.
62 2021-04-25 tingling reported tingling in bilateral arms post vaccine , set of vitals were in normal range after comfort... Read more
reported tingling in bilateral arms post vaccine , set of vitals were in normal range after comfort measures were taken discharged to home
62 2021-04-27 pain in extremity pain in his left leg, very severe; he can hardly walk now; he could hardly stand on his feet for 5 m... Read more
pain in his left leg, very severe; he can hardly walk now; he could hardly stand on his feet for 5 minutes; This is a spontaneous report from a contactable consumer (patient). A 62-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 11Mar2021 (Lot Number: EN6205) (at the age of 62-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure. Concomitant medication included lisinopril oral at 10 mg once a day taken for high blood pressure, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 18Feb2021 (Lot Number: EN6201) for COVID-19 immunization. The patient reported that he experienced: "pain in his left leg, very severe, he can hardly walk; he went to work, he could hardly stand on his feet for 5 minutes" on 05Apr2021. Caller stated that: "the pain goes from his ankle to his hip on his left leg". The patient due to the events visited the emergency department on 07Apr2021. Therapeutic measures were taken as a result of the events and included injection of some pain medication (not specified) but hasn't seen any improvement. The patient underwent lab test and procedure which included X-ray (left leg): unknown results on an unspecified date. The patient outcome of pain in his left leg was not recovered and unknown for the other events. No follow-up attempts are needed. No further information is expected.
62 2021-04-27 pain in extremity felt funny in his chest, like a really weird, really warm and heavy feeling; Sore Arm; This is a spo... Read more
felt funny in his chest, like a really weird, really warm and heavy feeling; Sore Arm; This is a spontaneous report from a contactable nurse. The nurse reported similar events for herself and her husband. This is the second of two cases. A 62-year-old male patient (reporter's husband) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 10Mar2021 at 16:00 as a single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medication included lisinopril (manufacturer unknown) taken for high blood pressure, start and stop date were not reported (reported as for over 5 years). The patient did not have prior vaccinations within 4 weeks from the the COVID vaccine. On 10Mar2021, the patient felt funny in his chest, like a really weird, really warm and heavy feeling. The patient did not freak out and didn't want to appear weak. It lasted 5 minutes and then it went away. It was a warm feeling in the chest and not being able to breathe. The patient also had a sore arm on 10Mar2021. The outcome of the event felt funny in his chest, like a really weird, really warm and heavy feeling was recovered on 10Mar2021 and the outcome of the event sore arm was recovered on 11Mar2021. The event felt funny in his chest, like a really weird, really warm and heavy feeling was reported as medically significant. The patient received the second dose of the vaccine on 31Mar2021. Relatedness of the suspect drug with the reaction 'felt funny in his chest, like a really weird, really warm and heavy feeling' from the Primary Source Reporter (method of assessment) is unknown. Information on the Lot/batch number has been requested.; Sender's Comments: Based on the narrative information provided, a causal association between the reported event Chest discomfort and BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021408430 same reporter and drug, similar events, different patient
62 2021-04-28 pain in extremity Severe Leg pain (especially calves. Both legs equally) Major Leg swelling Elevated D-Dimer Low plat... Read more
Severe Leg pain (especially calves. Both legs equally) Major Leg swelling Elevated D-Dimer Low platelets Elevated Liver enzymes General Body Aches. Shortness of breath Fever Rash Fatigue / Malaise
62 2021-04-29 seizure Seizure
62 2021-04-30 numbness, tingling numbness + tingling in both fingertips. No redness, swelling, rash, hives noted. No CP, SOB, dyspnea... Read more
numbness + tingling in both fingertips. No redness, swelling, rash, hives noted. No CP, SOB, dyspnea, blurry vision, HA. A&O x 4, able to speak in full sentences. Refused transport. VS: 100 HR, 97% RA, 177/87 (noncompliant with HTN meds), BS: 96. Observed for 30 mins.
62 2021-04-30 tingling his arm is "going back and forth with a tingling feeling, like when you cut off blood circulation to... Read more
his arm is "going back and forth with a tingling feeling, like when you cut off blood circulation to a limb, you get the tingling feeling; his arm is "going back and forth with a tingling feeling, like when you cut off blood circulation to a limb, you get the tingling feeling; This is a spontaneous report from a contactable consumer reported for himself. A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 62-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller reports that his arm was going back and forth with a tingling feeling, like when you cut off blood circulation to a limb, you get the tingling feeling. Reporting that his arm was going through that constantly back and forth even when doing nothing reporting that at one point its good, then the next minute it felt like the circulation was off. The patient was asking if his symptoms are normal and if he should get the second dose with these symptoms. Patients query was responded as he should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he 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. They referred him to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. His healthcare provider would know his health situation and had access to information that could better help inform this decision.The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
62 2021-04-30 tenderness This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received second dose of BNT162B2 (COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151; Expiration Date: Jul2021), via an unspecified route of administration at left arm on 12Apr2021 at 13:15 as single dose for covid-19 immunisation. Patient had historical vaccine first dose of BNT162B2 (at 62-year-old) lot number: ER8727, Expiration date: Jul2021 at left arm on 22Mar2021 for covid-19 immunisation showed tenderness in left shoulder. There was no patient medical history. There was no family history. There were no additional vaccines administered on same date of the COVID suspect. There were no prior vaccinations (within 4 weeks). No AE following prior vaccinations. The patient did not take concomitant medications. Patient experienced his arm is a little tender now on an unspecified date and received second dose that was clear on 12Apr2021. He received the first vaccination 3 weeks ago and this morning got the second vaccination. When he arrived, there was 30 minute delay. He saw the vaccines that were administered were transparent. It seems like it is not according to COVID standards. The person giving it said when it is diluted, it becomes transparent. He took it and is worried that it is not effective. The first dose was off white a little bit. It was not transparent and was exactly as described by the company. But now, it is transparent. He said that maybe they kept it too long outside, but they said it was correct. This same transparent one was given to several people before him. He did not provide any information on any others that had it. He wanted to know if that means it is not effective. They are doing it all the time. He later stated maybe the first one wasn't effective either. He just doesn't know. He later stated with the first dose, they knew what they were doing. He said he got the vaccine at pharmacy, does not have sample and didn't take photo. He thinks pharmacy did not dilute the vial correctly that's why it was clear, or they left it out too long. The pharmacy RPh told him they did it correctly. He doesn't believe it since the product is supposed to be off white after diluting. He did not see them do the actual diluting or shaking, just saw the vial sitting there. Site and PQM aware. He stated his arm is a little tender now and his temp is 98.4, it usually runs lower than that. He said he asked the company if he should get a third vaccine, he said they could not answer that. He said if anyone should know, its the company. Advised him to discuss his concerns with his doctor. No ER or physician's office visit required. The patient underwent lab tests and procedures which included body temperature was 98.4. Report not related to a study or program. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.
62 2021-05-01 tingling, numbness C/O FINGER TINGLING, AND NUMBNESS 177/87, DID NOT TAKE MEDS, 100, 97% BS 96
62 2021-05-02 weakness Fever, chills, muscle ache, headache, weakness. No special treatment; just rest, aspirin, drinking f... Read more
Fever, chills, muscle ache, headache, weakness. No special treatment; just rest, aspirin, drinking fluids. Lasted about 24 hours; felt fine the next day. Note: no reaction to first COVID vaccine injection 3 weeks earlier.
62 2021-05-02 night sweats Flu like symptoms: headache , body aches, fever, chills, night sweats
62 2021-05-02 tingling Patient presents with a potential reaction to the COVID19 vaccine. Patient-reported vague symptoms o... Read more
Patient presents with a potential reaction to the COVID19 vaccine. Patient-reported vague symptoms of some RUE tingling and R-sided facial tingling after RUE injection along with some neck tightness. The patient also reported mild generalized itching without rash, which he felt may be due to seasonal allergies. He requested 50mg oral Benadryl. Oral Benadryl given per request. Returned to baseline with monitoring.
62 2021-05-03 slurring, facial paralysis I63.9 - CVA (cerebral vascular accident) (CMS/HCC) R47.81 - Slurred speech R29.810 - Facial droop Z8... Read more
I63.9 - CVA (cerebral vascular accident) (CMS/HCC) R47.81 - Slurred speech R29.810 - Facial droop Z86.69 - History of Bell's palsy R51.9 - Headache"
62 2021-05-03 pain in extremity, numbness Left arm is in a lot of pain.; It falls asleep and I feel my circulation stopping. I feel numb and i... Read more
Left arm is in a lot of pain.; It falls asleep and I feel my circulation stopping. I feel numb and it causes my arm to fall asleep.; The pain runs to my chest and behind to the back of my ribs.; The pain runs to my chest and behind to the back of my ribs.; This is a spontaneous report from a contactable consumer (patient). This 62-year-old male patient received 2nd dose of BNT162B2 (lot_number EP6955) on 25Mar2021 at single dose on Left Arm for COVID-19 immunisation. Medical history was heart attack and was hospitalized to rule anything out, Hugh blood pressure, Cholesterol. Historical Vaccine was 1st dose of BNT162B2 (Lot number=EN6199) on 04Mar2021 on Left arm for COVID-19 immunisation. No other vaccine in four weeks. Left arm is in a lot of pain. It falls asleep and I feel my circulation stopping. I feel numb and it causes my arm to fall asleep. The pain runs to my chest and behind to the back of my ribs. I have a history of heart attack and was hospitalized to rule anything out. Events started from 08Apr2021. Events results in healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (3 days), disability or permanent damage. Treatment was Pain meds. Outcome of the event was Not Recovered. No covid prior vaccination. No covid tested post vaccination. No Known allergies. No follow-up attempts needed. No further information expected.
62 2021-05-04 pain in extremity After the vaccination in the morning, Sa-04-17-2021, have been in Urgent Care in the afternoon for a... Read more
After the vaccination in the morning, Sa-04-17-2021, have been in Urgent Care in the afternoon for an ongoing kidney stones issue that had occurred earlier this week. Felt tightness and pain in both lower legs which continued the next day, and it became worse. Mentioned this issue to the primary physician the following Monday 04-19-2021, but predominance had been given to the Kidney stones issue. On 04-26-2021 mentioned again the pain predominantly in the left calf to the primary physician. The same day, blood clots were found in both lower legs by Urgent Care. Had received information for Deep Vein Thrombosis by physician who prescribed Lovenox (enoxaparin) injections and advised to report the findings to V-safe. Continued narrative: Being informed by Urgent Care on 04-30-2021 that blood clots were not only in both lower legs, but also in both upper legs, now, after complaining about more pain. Ultrasound checks. Being advised to move and rest moderately. Received again information about Deep Vein Thrombosis. Advised to consider to skip the second Pfizer vaccination. Being on sick leave since 04-13-2021. Had switched from Lovenox to Pradaxa per prescription starting from Sa-05-01-2021. Urgent Care, 05-03-2021 conducted another ultrasound check. Another blood clot had developed. Again advised to consider to skip the second Pfizer vaccination, on SA-05-08-2021, to avoid more complications and risks. Under continued observation. Being alerted that this condition can lead to permanent damage and can turn life-threatening. Continued sick leave, considering medical leave. Concerned about the decision to take the second Pfizer vaccination, on Sa-05-08-2021.
62 2021-05-04 tremor fever, dizziness, lethargy, diplopia, and shakiness in arms. acute encephalitis. Intravenous immunog... Read more
fever, dizziness, lethargy, diplopia, and shakiness in arms. acute encephalitis. Intravenous immunoglobulins started 5/2-5/6. slow cognitive improvement. slow improvement in gait. Transferred to inpatient rehab.
62 2021-05-06 pain in extremity Very sore arm, fatigue, headache, then about 30 hours afterwards, extreme pain on right side under r... Read more
Very sore arm, fatigue, headache, then about 30 hours afterwards, extreme pain on right side under ribs, hard to breathe, went to ER, after several test performed, finding is PE in right lung and DVT behind right knee. I had signs of these weeks to months prior, have no underlying conditions before this happen, now I on Eliquis for blood clots! Also due to the blood clots have pneumonia!
62 2021-05-07 pain in extremity, muscle twitching Hives left hand, left cheek bone and then profound fatigue, bad insomnia and restlessness, severe bo... Read more
Hives left hand, left cheek bone and then profound fatigue, bad insomnia and restlessness, severe bone pain in right foot and right arm; heart palpitations and fast heart rate with dizziness and nausea; headache; Day 8 started having muscle twitches and cranial/ear buzzing; Day 8 experienced severe malaise and nausea and lightheadness; Day 18 difficulty walking in straight line; muscle twitches with heart palpitations very bad in evening; localized headache at left temple area, stiff neck and shoulders; eye vision blurry with heavy floaters and eye socket pain; extremely vivid dreams
62 2021-05-09 limb paralysis Began noticing rapid heart rate and dizziness approximately one hour after getting first dose of COV... Read more
Began noticing rapid heart rate and dizziness approximately one hour after getting first dose of COVID vaccine. Symptoms continued and worsened over next two weeks. Went to ER on April 11th, 2021, due to immense head pressure, BP over 200, and ringing in ears. My blood pressure and heart rate were checked at ER and were high, but came down after laying down for a while. I was given blood pressure medication, Amlodipine, 10 mg tablets. Medication had minor positive effects but symptoms continued to get worse. Returned to ER on April 14th, 2021. Same diagnostic testing was performed. I was given more BP medication and recommendations were made for how to lower blood pressure with diet and exercise.
62 2021-05-10 feeling cold, tremor, hot flush I recieved the 1st shot at about 5:30 pm and by 10:00 am the following morning is when the symptoms ... Read more
I recieved the 1st shot at about 5:30 pm and by 10:00 am the following morning is when the symptoms started: head aches, nauseous (that lasted for 4 days), body aches. Hot and cold flashes followed by upset stomach and throwing up. Dizziness chills and trembling of the hands and then diarrhea (that lasted for about 8hrs or so); Sleep was internment for about 3 days and then the symptoms slowly started to fade. Taste for food and nauseousness (after I ate) last for about 5 days after the shot.
62 2021-05-10 numbness, bell's palsy 1st dose 15Mar2021; 2nd dose 01Apr2021; diagnosed with Bells Palsy; On Wednesday, 14Apr I started e... Read more
1st dose 15Mar2021; 2nd dose 01Apr2021; diagnosed with Bells Palsy; On Wednesday, 14Apr I started experience numbness to the right side of my face; This is a spontaneous report from a contactable consumer (the patient). A 62-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EP7534), via an unspecified route of administration, on 01Apr2021 at 16:30 (at the age of 62-years-old) as a single dose administered in the left arm for COVID-19 immunization.The patient's medical history was not reported. The patient has no known allergies. Prior to vaccination, the patient had not been diagnosed with COVID-19. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6205) in the left arm on 15Mar2021 at 16:30 (at the age of 62-years-old) for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any other vaccinations within 4 weeks prior to the COVID vaccine. The patient stated that on Wednesday, 14Apr, she started to experience numbness on the right side of her face. She went to the ER and was diagnosed with Bell's Palsy. The patient experienced diagnosed with Bell's Palsy on 14Apr2021 at 16:30 with outcome of recovering and "numbness to the right side of my face" on 14Apr2021 at 16:30 with outcome of recovering. Therapeutic measures were taken as a result of Bells Palsy and and hypoaesthesia and included the administration of prednisone (not further specified). It was also mentioned that since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
62 2021-05-10 muscle spasms severe cramps in calf's and thighs; cramps as bad as bruises and calf's bruise; This is a spontaneou... Read more
severe cramps in calf's and thighs; cramps as bad as bruises and calf's bruise; This is a spontaneous report received from a contactable consumer (patient). This 62-year- old male patient received his 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733) at single dose via an unknown route in left arm on 09Apr2021 for Covid-19 immunization. Medical history included anxiety. Concomitant drugs included cariprazine hydrochloride (VRAYLAR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), clonazepam for anxiety. Patient had been having severe cramps in calf's and thighs in Apr2021. Patient had a shot on "Friday" and it started "Tuesday" (also reported as "may be 12 or 13Apr") night. Patient had been having cramps as bad as bruises and calf's bruise and the muscles "that are lined". No treatment received. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
62 2021-05-10 tingling, muscle spasms Took covid vaccine on 1/26/2021 first dose with reaction of fever on post vaccine day 1 and 2 and co... Read more
Took covid vaccine on 1/26/2021 first dose with reaction of fever on post vaccine day 1 and 2 and cough starting 3 days ago Fever free for last 24 hours . Last fever was 1/27/2021. Dizziness today for 4-5 mins ,non since . No rapid or slow heartbeat, chest pain or other sx Tingling of both upper extremities. Feels like the world is spinning around him. Also gets some tingling in hands and arms which is mainly on the left. Feels some spasms and body aches. Legs hurt at times. Feels like he is out of his skin..
62 2021-05-11 pain in extremity Continuous pain in left arm
62 2021-05-13 weakness, numbness 7:45am April 13th, 2021 at hospital I was very excited to finally get the vaccine ...I was given th... Read more
7:45am April 13th, 2021 at hospital I was very excited to finally get the vaccine ...I was given the Pfizer shot in my upper left arm and felt small pain a the site of injection ...In 5 minutes I felt nauseated, very dizzy and weak to the point of falling off the chair ...they gave me two cups of orange juice and a few fig bars in the hopes that I was just having low blood sugar ...I was offered a hospital bed to lay down ...I experienced numbness in my left arm and in both hands ...also across the lower part of my face ...I was at the hospital for over an hour an was unable to return to work ... A few days later I began experiencing high pitch ringing in both ears that has gotten worse to the point of being so loud I can't hear a person talking to me on the phone ...noises around me are extremely painful to my inner ear ...this high pitch sound wont go away and keeps me up all night ...I have been to the hospital several times to see ENT doctors and I have tried many medications to help me sleep with this 24/7 tortuous ringing sound ...I can keep myself busy all day trying to ignore it yet at night it haunts me like a demon ...please contact me with any help you know of to reduce this sound in my ears ...I am extremely desperate for sleep ...
62 2021-05-13 pain in extremity, burning sensation, tingling Soreness on the around the shot site; Severe arm pain up where the rotator cuff is; Severe arm pain ... Read more
Soreness on the around the shot site; Severe arm pain up where the rotator cuff is; Severe arm pain up where the rotator cuff is; Has not slept due to pain; cannot sleep, the pain wakes him up; Could not use his arm; 50% deficit with the use of his left arm; After the vaccine, he could not lift his arm above his mid face level; Burning and tingling down the left arm; went to his hand and fingertips and progressed to the whole left side of his body including his rib line, hip, leg, and foot; Burning and tingling down the left arm; went to his hand and fingertips and progressed to the whole left side of his body including his rib line, hip, leg, and foot; Nauseous; This is a spontaneous report from a contactable consumer (patient who is a retired paramedic). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8732), via an unspecified route of administration in left arm, on 30Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included bipolar depression from probably 10 years ago (2011) and ongoing, torn rotator cuff (15 to 20 years ago), and food poisoning in mid-Aug2020 (maybe it was more than that; may get tested to see if he ever had COVID-19). The patient's concomitant medication included vilazodone hydrochloride (VIIBRYD) from 2017 and ongoing (for at least four years) for bipolar depression. The patient has no known allergies. The patient was one of those people who doesn't get sick and he doesn't normally get the flu shot and everyone told him to get this Pfizer vaccine. The patient was not panicking but got the first dose of the Pfizer Vaccine on Tuesday (30Mar2021) around 01:00 PM and saw some things about having soreness on the around the shot site and all of that from that night (30Mar2021). This is going on for three days (from 30Mar2021) with severe arm pain up where the rotator cuff is; if you ever have pulled a rotator cuff it feels like that and he has not slept in almost 3 days due to pain from 30Mar2021. The pain is severe at times that it makes him nauseous (Mar2021). He figured the soreness was normal and later in the evening on 30Mar2021, the pain became an issue when he tried to go to bed that evening. Since the first two nights compared to last night, the soreness is actually improved; every time he tries to sleep with pain as a factor it is not easy. The patient can feel throbbing with his heartbeat and with the circulation there is throbbing pain. The pain was terrible and was throbbing like his heartbeat and similar to like a shoulder rotator cuff injury. For the first two days, on Tuesday (30Mar2021) and Wednesday (31Mar2021) after the vaccine, he could not use his arm or lift his arm above his mid face level. According to the patient, it was like a rotator cuff and he had a torn rotator cuff 15 to 20 years ago and this is the same arm that his torn rotator cuff occurred in; this is very painful and he is comparing it to the torn rotator cuff. In Mar2021, the patient had burning and tingling down the left arm and 3 days no sleep because the pain is worse at night. During the last week (Mar2021), his left leg down to his foot is also tingling and burning. The patient's primary care physician just retired, and he is in the process of finding a new one. The patient had no treatment or physician or emergency room (ER) visit for the reported events because being in the ER field, he can tell right now that it would be a waste of time of the effort to go into the ER as they would do nothing but tell him to take paracetamol (TYLENOL) and that is it. The patient did not like to take paracetamol and hates taking paracetamol. The patient clarified it is generic acetaminophen extra strength (Strength: 500 mg; Lot Number: P119682, Expiration Date: Mar2022, UPC Number: 5084417594) that he has taken (maybe every 6 hours oral) and it does relieve the pain so that is only so good. He does not know if in motion of the course of the day, something happened because at night laying still in bed is when he has pain. The patient did a lot of research before he made this call and the severity of the pain is enough to actually keep him awake for three days. He thought it was severe pain; maybe he should have told them to administer the vaccine in his right arm, but it was administered into his left arm. The only reason he made this call was because he wanted someone to know what he was having which could be just completely normal and he is sure every reaction is different and he expected the soreness because he remembers as a kid having shots. Also, this level of pain he is experiencing is what he wanted to report; imagine having himself going three days without a full night of sleep and he wanted to report this to make sure Pfizer knew this if they were keeping track of numbers of how many people have a similar pain level. The patient also asked if there were other people who called and reported these symptoms and if there is any information or treatment recommendations. As of 08Apr2021, even up to five days after getting the shot, now going on seven days that he has had some pretty severe reactions. The patient called in after 3 nights of getting no sleep. The patient was calling today to see if someone was ever going to call him back and asking will there be a follow up call from someone to see if he's still alive. The patient had some pretty severe reactions and they have actually gotten worse. There also have been new developments. The patient had pain in his arm that pulses along with his heart rate. It is so bad that it kept him up for 3 nights and still wakes him up at night. The pulsing pain in his arm started on the first night and has gradually gotten worse. The pain in the arm that is enough that it keeps him awake at night only starts getting severe when he goes to bed. He has tried sleeping in an upright position and he has tried everything, and nothing seems to alleviate it. The patient took generic acetaminophen which did not work during his last phone call. The patient also tried naproxen sodium (ALEVE) and that doesn't work wither. It was absolutely debilitating at times to where he has a 50% deficit with the use of his left arm (Mar2021). The patient initially reported burning and tingling sensation that was on his left arm and went to his hand and fingertips but now it has progressed to the whole left side of his body including his rib line, hip, leg, and foot. He is a retired paramedic and is pretty sure he is not having a long stroke. The patient feels it is too long to have symptoms from a shot he got. The patient has a lot of friends in the medical field and he's been told even going to a primary care physician, it is kind of gray area when it comes to dealing with COVID-19 vaccines. The patient was having second thoughts about getting the second shot. He had been told he can take NSAIDS over the counter for pain which has not helped him; there is no protocol for diagnosing or treating anything that happens from the shot. People in the medical field have told him there is thin line now to treat side effects because of liability; some doctors won't even get into it, just refer to Pfizer because medical insurance will not cover any services related to COVID-19 vaccine reactions. The patient continues to explain that is why the federal government is the only one that owns the shot due to liability. The patient's main concern is calling and reporting and maybe getting some help in deciding whether or not to get the second dose of the Pfizer COVID-19 vaccine. In his opinion, that is too long to have pain that he cannot sleep, the pain wakes him up. This all happened along with the shot, the same night and there are times where he can't work due to it. The patient asks if anyone is concerned with it and will someone feel bad because he doesn't get the second shot. His main concern is that people are underscoring or even lying about side effects, stating he can't believe he is an isolated case. The patient continued to ask if this is something he's stuck with, or if it is something he would have to deal with from now on from getting this shot. The patient regrets getting the first shot and stated that if he knew then what he would be going through now, he wouldn't have got it. The patient has no sort of history of being a hypochondriac and the feelings he is going through right now are sensations that he has never felt in his life. The patient continues to explain he doesn't even know how to categorize it other than mentally relating it to the shot since it all occurred in line with Mar2021 getting the shot. The patient further commented that if he ran a call with an ambulance right now with a patient telling him what i he was telling the company, he wouldn't even know what to do with them other than getting them comfortable and to a hospital. The patient had not recovered from "Soreness on the around the shot site", "Severe arm pain up where the rotator cuff is", and " Has not slept due to pain; cannot sleep, the pain wakes him up". The outcome of the other events was unknown.
62 2021-05-14 weakness He has been having diarrhea for the past 2 weeks ever since he received a second Covid vaccination h... Read more
He has been having diarrhea for the past 2 weeks ever since he received a second Covid vaccination he has been increasingly weak and could barely make it into the pulmonary function lab. At the pulmonary function lab, he was found to have new onset atrial fibrillation and worsening hypoxemia from baseline. Taken to ED from the lab on 5/12, found to have right middle lobe and right lower lobe consolidation and ground glass changes. Admitted. Conditioned worsened, respiratory acidosis and shock, started on biped and pressors. Taken to ICU. Found to have RV failure. Today he was intubated.
62 2021-05-14 speech disorder, tremor it could potentially be his Parkinsons; he started to shake and now is still shaking; he can't conce... Read more
it could potentially be his Parkinsons; he started to shake and now is still shaking; he can't concentrate; he doesn't think right; cannot talk right; he has a hard time moving, he moves so slowly; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old (age at time of vaccination) male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on 14Apr2021, as a single dose for COVID-19 immunization at clinic. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history included ongoing Parkinson's from 2010. He did not know about family history of having Parkinson's. Concomitant medications were not reported. The patient did not receive any vaccine within 4 weeks prior to vaccination. The patient reported that after two vaccines on an unknown date in Apr2021, he started to shake and now was still shaking. He was wondering why he was shaking so hard. He said it could potentially be his Parkinson's and asked what he should do. Mailing and email address declined. Primary care doctor's address, telephone number, and email address declined. The patient stated the doctor was not in. Shaking was noticed after the second dose. It was improved, but he didn't like it. He could not concentrate, he didn't think right, and could not talk right. When asked to provide information from vaccine card, the patient stated he had a hard time moving, he moved so slowly and had card but could not find it. He also could not recall date of first vaccine, but both doses were given to right arm. Time the vaccination was given: 10:14:2020, was the time that second dose was received. Time was documented as provided, and confirmed, by caller. He had first one and was given another 3 weeks to come back. He was waiting for his doctor and stated he had Parkinson's, diagnosed in 2010. There was no product complaint to report. Outcome of the event he started to shake and now is still shaking was recovering and for all other events, it was unknown. Communication: Caller had a thick accent- details were as provided by caller with clarifying attempts. Information about lot/batch number has been requested.
62 2021-05-19 cold sweat Patient was not feeling well with diarrhea and fatigue past 24 hours. After vaccination, patient wen... Read more
Patient was not feeling well with diarrhea and fatigue past 24 hours. After vaccination, patient went to observation area where they felt fatigue, sweating, and clammy. Patient alerted nurse they were not feeling well, and nurse noted patient was breathing fine. No rapid response was called, however patient was sent over to ED with wheelchair. Patient appears stable, but is being worked up in ED now.
62 2021-05-22 muscle twitching Started getting muscle twitch in right side of neck and shoulder. It lasted from minutes to hours. D... Read more
Started getting muscle twitch in right side of neck and shoulder. It lasted from minutes to hours. Doctor suspected pinched nerve and recommended physical therapy. Started PT 4-28. Neck muscle twitch stopped after 2nd PT session on 4-29. Completed PT on 5-20. I am now getting muscle twitches in my back, left arm, left hand and left eye. The twitch is random and lasts about one to two minutes. As of this date (5-23) it has not resolved.
62 2021-05-24 numbness, mild one side paralysis 4/11-4/17 Stiff neck and shoulders. Could hear whooshing sounds of my blood circulating at times squ... Read more
4/11-4/17 Stiff neck and shoulders. Could hear whooshing sounds of my blood circulating at times squeaking sounds 3 different occasions. Thought I might have an ear infection and called Teladoc was prescribed Oxi Clav 825 mg . 2x day. 4/25-4/26 significant temporary loss of control of left arm and left leg felt wobbly but intensity subsided to minor loss of mobile control.4/27 Left leg went totally numb from the knee down with no control couldn't wiggle toes , Left should went numb 2x left face went numb 1x Stroke, total blockage of left corroded artery
62 2021-05-25 weakness Fatigue, unspecified type Dizziness Fever, unspecified fever cause Weakness COVID-19 virus infec... Read more
Fatigue, unspecified type Dizziness Fever, unspecified fever cause Weakness COVID-19 virus infection Office Visit 5/12/20Family Practice PA Family Medicine COVID-19 virus infection +4 more Dx Cough Reason for Visit Progress Notes (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 5/12/2021 Cosign Needed Expand AllCollapse All Assessment/Plan TENT. 1. covid positive - symptoms and diagnosis occurred x15 days ago. He was improving but starting yesterday he has developed R sided chest pain and has been slightly SOB. Cough has worsened as well. He has not been taking ASA, will rule out PE at this time. STAT chest CTA ordered, CBC, and CMP. Possibility of secondary pneumonia but will hold off on abx for now, review after chest CTA results. Continue Acetominaphen and hydrating. If any symptoms worsen or the following occurs go directly to ED; fever/chills, chest pain, SOB. Patient understands and agrees. If chest CTA rules out PE and shows pneumonia would cover w/ azithromycin/ceftin/prednisone. Diagnoses and all orders for this visit: COVID-19 virus infection - CBC; Future - Comprehensive metabolic panel; Future - CT angiogram chest pulmonary embolism with and without contrast; Future Fatigue, unspecified type - CT angiogram chest pulmonary embolism with and without contrast; Future Other chest pain - CT angiogram chest pulmonary embolism with and without contrast; Future Tachycardia - CT angiogram chest pulmonary embolism with and without contrast; Future
62 2021-05-25 discomfort Day after 2nd dose, discomfort stayed in bed. 2nd day after dose shoulder pain radiating to chest, d... Read more
Day after 2nd dose, discomfort stayed in bed. 2nd day after dose shoulder pain radiating to chest, during night intense chest pain with extremely shallow breathing. By morning chest pain so bad I went to E.R. I was admitted with normal EKG and oxygen levels. Elevated test that indicates blood clot in lung. CT scan done. Diagnosis Pulmonary Embolism. Was admitted to hospital for 2 days while undergoing heparin and warfarin therapy and pain relief. Prescribed blood thinners for 6 mos. After release severe fatigue and low HGB levels limited walking of more than 50' without losing consciousness. It has been 1 month and still can only walk 100' without lightheadedness.
62 2021-05-27 severe one side paralysis, tingling, discomfort, difficulty speaking, pain in extremity 3/26/21 After Pfizer vaccine noticing hives on chest and left arm as well as facial tingling and sli... Read more
3/26/21 After Pfizer vaccine noticing hives on chest and left arm as well as facial tingling and slightly left eye itchiness. Received 2 dose of Epinephrine during ED visit. 5/13/21 After Janssen vaccine he received at this morning around 8:10 AM. After that he had almost the exact same symptoms with a shooting pain in the left arm and neck some left hand tingling and swelling to the point where he can't get his wedding ring off and a sensation of pressure/tingling/fullness in the left side. Given Benadryl and steroids, initially there is no airway concerns or compromise. However after a period of time, he thought his voice was different. He did sound just slightly raspy, though I did question whether this could be related to dryness from the Benadryl. Regardless given that he did note a change, we opted to go ahead and give a dose of epinephrine, which did resolve his symptoms
62 2021-05-28 numbness GBS. Sensory issues, numb feet, can?t walk. Received 5 Ivig treatments in the hospital in a step do... Read more
GBS. Sensory issues, numb feet, can?t walk. Received 5 Ivig treatments in the hospital in a step down unit
62 2021-05-28 pain in extremity This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9262) dose 1 via an unspecified route of administration on left arm on 26Jan2021 at single dose for covid-19 immunization. Time the vaccination was around noon. No prior vaccinations within 4 weeks. Medical history included ongoing blood pressure high. Concomitant medications included metoprolol 50mg once a day taken blood pressure from an unspecified start date ongoing. On 27Jan2021, Wednesday he started to feel pain in his arm which he knew was normal. But now he started to feel his temperature rise and usually takes his temperature every day as he works with the fire department. On 28Jan2021, Thursday he started to notice the rise in temperature. Then it was kind of within normal, but it was 98.4. However, this morning when he took his temperature it was 100 degrees. His usual temperature was between 97-98 degrees. He also had a cough last night and did not had the cough this morning. More, or less the main thing bothering him is the temperature. He has taken some Tylenol 500mg. He stated he does not know if he should be taking Tylenol. He was drinking more tea, coffee, and juice. The pain in his left arm was not immediate and was delayed. He does not know what time it started, but it was early in the day. He was coughing last night but he was not doing it on a consistent basis. Later he was doing it all day but did not know what time it started. He said as pretty much has subsided, no additional details provided. The patient underwent lab test which included body temperature resulted as 98.4 on 28Jan2021 and on 29Jan2021, body temperature resulted as 100. The clinical outcome of the event pain in arm and cough was recovering and the clinical outcome of the event rise in temperature was unknown. Follow-up attempts are completed. No further information is expected.
62 2021-05-28 pain in extremity Since 5/10/21 (through today 5/29), Left Shoulder / Arm soreness and swelling especially in left elb... Read more
Since 5/10/21 (through today 5/29), Left Shoulder / Arm soreness and swelling especially in left elbow which spread to lower left leg especially in left knee.
62 2021-05-31 facial paralysis, numbness, bell's palsy Developed facial numbness and paralysis of left side of face Diagnosed with Bell's Palsy
62 2021-06-01 tingling Itchy TIngling skin approximately 1 week after vaccine, using Cortisone 10
62 2021-06-02 cold sweat Eyes open in fixed stare for approximately 30 seconds. Would not respond verbally. Was pale and skin... Read more
Eyes open in fixed stare for approximately 30 seconds. Would not respond verbally. Was pale and skin clammy. Cool cloth to base of neck. Waiting in personal van with passengers seat partially reclined. Back to normal state by end of 15 minutes wait. VS were BP 97/66, pulse 57, pulse ox 97% Held for additional 15 minutes to further monitor. Was able to lay down for first Covid vaccination and had no adverse reaction(s). States his mother also reacts porky to any injection.
62 2021-06-02 migraine I received my first vaccination on March 24, 2021 at 9:50 am at Hospital. Within 24 hours I started ... Read more
I received my first vaccination on March 24, 2021 at 9:50 am at Hospital. Within 24 hours I started to get migraine headaches. I never have gotten migraine headaches. The migraine headaches never went away. After several weeks I contacted my doctor. He prescribed migraine medications. The first two medications didn?t work, the third helped. I had taken them for about two weeks and thought I would try to go off of the medicine, no luck, the migraine continues to exist. It?s been over two months. I finally had a MRI which came back negative. I really need some answers to try to figure this out. I had never had migraines in my life and now I have a constant migraine all the time. Looking for solutions not medications. Thank you.
62 2021-06-03 bell's palsy G51.0 - Bell's palsy
62 2021-06-03 pain in extremity pt says the next day after taking the vax his arm was a little sore but when he stood up he had a ha... Read more
pt says the next day after taking the vax his arm was a little sore but when he stood up he had a hard time moving around, he was hyperventilating and he felt very exhausted. He got a severe pain in his left hip. He said the pain was so intense he could barely move so he took a low dose pain killer. He was in so much pain he curled up in a fetal position and rock back and forth. He says he was crying and in a hallucination state for about an hour. After that the he said the symptoms seemed to be getting better but was completely exhausted. His eyes were red and had trouble with his vision. On 6/4/2021 he still has some pain and has an ache inside the bone, gets winded w/ moving around but says his symptoms seemed to be improving.
62 2021-06-07 pain in extremity shortness of breath; Fever 100 +; left arm pain; malaise/feel sick; headache; feel sick and tired; T... Read more
shortness of breath; Fever 100 +; left arm pain; malaise/feel sick; headache; feel sick and tired; This is a spontaneous report from a contactable other Health Professional (patient). A 62-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 18May2021 14:45 (Batch/Lot Number: Unknown) at the age of 62-year-old, as 1st dose, single for covid-19 immunisation. Medical history included covid-19. Prior to vaccination, the patient was diagnosed with COVID-19. There were no concomitant medications. The patient previously received other Pfizer vaccine (unspecified name) on 27Apr2021 administered in left arm for immunisation. The patient experienced shortness of breath, fever 100 +, left arm pain, malaise, headache, feel sick and tired on 19May2021. No treatment was taken for adverse event (AE). Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering. Information about lot/batch number has been requested.; 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 shortness of breath 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.
62 2021-06-08 bell's palsy Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male ... Read more
Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Apr2021 16:30 (at age 62-year-old) (Batch/Lot Number: EP7533) as 1st dose, single dose for covid-19 immunisation. Medical history included neurofibromatosis from an unknown date and unknown if ongoing. There were no concomitant medications and no other vaccines received in four weeks. The patient experienced Bell's palsy on 23May2021 08:00. Prednisone and Valtrex was given was treatment. Outcome of the event was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
62 2021-06-10 weakness, muscle spasms Felt tired; Back hurts; Pop in neck and back; Pop in neck and back; Headache; Cramps, sometimes in h... Read more
Felt tired; Back hurts; Pop in neck and back; Pop in neck and back; Headache; Cramps, sometimes in his legs and hands; Feels weak sometimes; Has a little bit of pain in his chest; Body hurt, reclarified, joints hurt; This is a spontaneous report from a contactable male consumer reported for himself. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 03May2021 (at the age of 62-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient previously received the first dose of BNT162B2 vaccine on an unspecified date (lot/batch and expiry date unknown). The patient medical history and concomitant medications were not reported. On 03May2021, after the vaccination, the first day patient felt tiredness, later (unspecified date in May2021) the patient explained his body hurt- reclarified as joints hurt, back hurts, pop in his neck and back, headache, cramps sometimes his legs and hands, feels weak sometimes, little bit of pain in his chest. Caller stated he has waited for his effects to go away, but it has been a month. Caller stated his body hurt, reclarified as joints hurt, and it was not going away (not recovered). The outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
62 2021-06-10 weakness Severe vomiting during overnight period into next day (approximately 12 episodes in 12 hours), sever... Read more
Severe vomiting during overnight period into next day (approximately 12 episodes in 12 hours), severe cranial pain/headache, open sore in esophagus/lower throat that prevented eating solid foods for 10 days and liquids for at least the first week, even water. Painful area surrounding sternum (uncertain if it was from the vomiting action or possibly heart damage), which also prevented food or liquid to pass down the throat due to spasms, localized pain and possibility of inducing vomit reflex. High blood glucose (ketoacidosis). General overall weakness/lack of energy. Loss of mucous in nose, throat and stomach. Loss of saliva in mouth for first week. Insomnia. High blood pressure.
62 2021-06-10 bell's palsy Belle's Palsy, Left side of face. Treatment Anti-Viral and Prednisone. Has not normalized to date... Read more
Belle's Palsy, Left side of face. Treatment Anti-Viral and Prednisone. Has not normalized to date.
62 2021-06-10 pain in extremity Arm hurt a little; This is a spontaneous report from a contactable consumer. A 62-years-old male c... Read more
Arm hurt a little; This is a spontaneous report from a contactable consumer. A 62-years-old male consumer (patient) reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, expiry date and NDC number were not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history, other products, investigation assessment and concomitant medications were not reported. On an unknown date, the patient reported that his arm hurt a little bit after first shot of vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
62 2021-06-11 feeling of body temperature change 31March2021 rec'd the 2nd Pfizer shot. Next morning 1April, multiple stripes of severe muscle pain f... Read more
31March2021 rec'd the 2nd Pfizer shot. Next morning 1April, multiple stripes of severe muscle pain from both ears, extending down the rear corners of neck across top of both shoulders to the shoulder joints. The 2nd set of severe pain was thin stripes of pain on the left & right sides of the spinal column from the neck to waist. The pain strips along spine disappeared in 3 days. The neck pain has continued to this day with varying intensity, sometimes random increases in pain. 7th of April 2021: Sudden onset of Covid like symptoms: extreme fatigue, extreme nausea, wild swings in perception of body temp from freezing cold which nothing warms me, to internal heat like a very high temp but not exhibiting any outward signs of fever. Felt like internal organs were heating up and nothing else like forehead or limbs etc. The symptoms of 7April2021 kept up for at least 2 weeks. No symptoms occurred together, each symptom came for varying lengths of time before subsiding and the next symptom surfaced. Towards the end of April the intensity of the symptoms was easing and eruptions were getting fewer with more time between. By end of May only the neck pain remained. BUT.... then the other symptoms reappeared in stronger form and still ongoing.
62 2021-06-13 feeling cold AT about 11 pm I got up to go to bed, and all of the sudden I felt like I was freezing and shaking v... Read more
AT about 11 pm I got up to go to bed, and all of the sudden I felt like I was freezing and shaking violently. I couldn't even hold my phone to call 911. I passed out. I woke up about 3AM on the floor. I was shivering. I got to bed, called my girlfriend, then fell asleep. The next morning it felt like I had COVID again, I had COVID back in December. I called the doctor, and they if I experienced it as bad as the night before then I should go to the ER, otherwise stay in bed, rest, and drink fluids.
62 2021-06-16 migraine, weakness painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was admi... Read more
painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was administered; Hard to lift up arm, nothing noticeable on arm; bloodshot eyes; muscle aches; unable to take full breathes/shortness of breath; minor cough; migraine headache; chills; exhausted; aches; nausea; covid like symptoms; body aches; low energy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 15:30 (Batch/Lot Number: EW0173) as single dose for covid-19 immunisation. The patient medical history was reported as none. Patient had not any known allergies. Patient had not received any other vaccine in four weeks nor received any other medications in two weeks. The patient did not received concomitant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 07:30 PM, as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 2nd shot administered on 03May2021 and on 08May2021 09:00 PM six days later developed migraine headache, chills, exhausted, aches, nausea. Chills, migraine, lasted 1 day, night of 08May2021- 09May2021. It was reported that due to lifting weights, vaccine was trapped in the arm/shoulder muscle, released slowly where he developed covid like symptoms 6 days after shot followed by week of covid like symptoms, shortness of breath, body aches, exhausted, low energy. Week of 10May2021 exhausted, bloodshot eyes, muscle aches, unable to take full breathes, developed a minor cough. On 15May2021- 16May2021, painful left arm/shoulder where shot was administered. Hard to lift up arm, nothing noticeable on arm. No treatment was received for the events. The seriousness of events was reported as non serious by the reporter. The outcome of the events chills, migraine were recovered on 09May2021; events painful left arm/shoulder where shot was administered and hard to lift up arm were recovered on 16May2021 and recovering for other events.
62 2021-06-16 pain in extremity, weakness It felt like his intestines were twisting in knots; diarrhea; joint pain; chills; muscle pain; tired... Read more
It felt like his intestines were twisting in knots; diarrhea; joint pain; chills; muscle pain; tiredness/exhausted; dizziness; weakness/lost strength; Arm pain; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0179), dose 1 via an unspecified route of administration, administered in left arm on 20May2021 10:00 (at 62-year-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included ongoing HIV positive from an unspecified date (reported as 5-6 years ago), ongoing immunocompromised due to being HIV positive. History: Patient has been taking BIKTARVY daily ever since he became HIV positive which was years ago. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV positive. He did have vaccinations but he had them way longer than the 4 weeks prior to receiving his first dose of the COVID vaccine. No events following prior vaccinations. The patient stated he received his first dose of the Pfizer COVID-19 vaccine on 20May2021 and this weekend 29May2021 into 30May2021 he developed diarrhea, joint pain, chills, muscle pain, tiredness, dizziness and weakness. He's not sure if he had food poisoning over the weekend or what, but he has been suffering. He received his first dose on 20May2021, and the next dose wasn't due until 10Jun2021. He was reading through the literature and he sees that there are issues with immunocompromised people and all the medications that make a person immunocompromised which he is on. He has been reading the side effects and he has experienced diarrhea from hell, joint pain, he had chills, muscle pain and tiredness. He mentioned he did have some arm pain. He mentioned he didn't have anything soon, it was a little over a week. He also experienced dizziness and weakness, he felt like he lost strength or something like that. It may be coincidental and he could have gotten food poisoning or something over the weekend. Patient clarified his symptoms began on Saturday night, 29May2021 into Sunday, 30May2021. On 31May2021, his symptoms were a little milder, but then towards afternoon, his symptoms started back up. It felt like his intestines were twisting in knots and his diarrhea was back. He mentioned he had been taking Pepto Bismol and Alka-Seltzer. He confirmed the arm pain and diarrhea were still ongoing, however, the rest of his symptoms had pretty much improved. He clarified if he does too much too quick, his tiredness comes back. He felt like he was just zapped, he felt exhausted. The events did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included weight: 157-158 lbs on an unspecified date. The outcome of events arm pain and diarrhea was not recovered, outcome of the other events was recovering.
62 2021-06-16 pain in extremity, tingling Two days following vaccination, I began to experience at random a pronounced tingling sensation alo... Read more
Two days following vaccination, I began to experience at random a pronounced tingling sensation along the path of the nerve in my right arm EXACTLY where I had presentation of shingles three years prior (mild case, limited to right arm). Each presentation of tingling lasted only a few moments to perhaps 30 seconds; it was NOT painful at all, and it was NOT debilitating in any way (did not interfere with function of my arm). Presentations occurred usually hours apart, initially experienced perhaps 4 or 5 occurences during waking hours. Over the next three weeks (prior to my second shot on 5/20/21), presentation of tingling sensation abated in degree and frequency; however, even up to this date (6/17/ 21) I experience SOME tingling from time to time.
62 2021-06-20 muscle spasms Muscles spasms
62 2021-06-21 tingling, pain in extremity, numbness As soon as she did the injection I can feel the med going into my arm and it started tinging and I s... Read more
As soon as she did the injection I can feel the med going into my arm and it started tinging and I stayed for the 15 mins and then my hand and arm started feeling numb. During the 15 mins I was waiting I ask the guy do this suppose to happen and he said that after the 15 min way, it should go away. An then the next day my hand was still hurting and the next I called my PCP and said, nothing that we can do. An then I waited and I called a doctor friend at Clinic and take Claritin because it was itching and so he said to try calamine lotion. It seemed to help but I would still have the numbing feeling. It felt like nerve damage. So I called Dr. and she gave a prescription for Betamethasone Dipropionate cream USP (Augmented). It has helped but it is still there on my arm. I can only use it for 2 weeks. It has only been a week. So, we will see what happens.
62 2021-06-22 pain in extremity Pain in finger joints when waking up in the morning. My wife got the vaccine the same day and we bot... Read more
Pain in finger joints when waking up in the morning. My wife got the vaccine the same day and we both developed the same finger joint pain
62 2021-06-23 weakness Pt states month after 2nd dose chest tightness, sweating, fatigued. Since then no breath, low energy... Read more
Pt states month after 2nd dose chest tightness, sweating, fatigued. Since then no breath, low energy. Feels like his heart is pounding out of his chest. Doctors ordered stress test, Ekg 04/28/2021. Extreme mental state stress.
62 2021-06-24 numbness numbness in left toes - mainly middle toes; This is a spontaneous report from a contactable consume... Read more
numbness in left toes - mainly middle toes; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown) via an unspecified route of administration into left arm as first single dose for COVID-19 immunisation on 18Mar2021 at 10:30 (at the age of 62 years). Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient had not been tested for COVID-19. The patient had allergies from dust mites and grass. Concomitant medications included nexum (MANUFACTURER UNKNOWN) for unknown indication started from unknown date, floranase (MANUFACTURER UNKNOWN) for unknown indication started from unknown date, florachrome (MANUFACTURER UNKNOWN) for unknown indication started from unknown date, alegra (MANUFACTURER UNKNOWN) for unknown indication started from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 16:00, the patient experienced event numbness in left toes, mainly on middle toes. The clinical outcome of the event numbness in left toes was not recovered at the time of report. No follow-up attempts are needed; information about lot number cannot be obtained.
62 2021-06-24 tingling I had pain in my injection site and it has subsided but literally for 4 months from march until earl... Read more
I had pain in my injection site and it has subsided but literally for 4 months from march until early June I had pain at the injection site. I had an acupuncturist come and massage the injection site. I went to my doctor and she took an MRI and my whole left hand tingles. I still have a slight tingle now. I had to get a pain killer because I had to take the MRI and I lay on my left shoulder and I could not move but it was painful so I took the pain killer. As the pain has subsided the tingling has increased. What my doctor said is that I was injected in my rotator cuff.
62 2021-06-25 discomfort chest heaviness/discomfort/ dull pain next to left arm till today no treatment usually constant disc... Read more
chest heaviness/discomfort/ dull pain next to left arm till today no treatment usually constant discomfort till today
62 2021-06-27 burning sensation, facial pain On the left side of the callers face down to his chest, pain and itching and burning and a rash. The... Read more
On the left side of the callers face down to his chest, pain and itching and burning and a rash. The caller went to the ER and the doctors gave benadryl and cream and said it was an allergic reaction. there is still a rash, and it is burning and painful.
62 2021-06-29 feeling cold Rash on torso (trunk); Chills; Very cold; Nauseated; This is a spontaneous report received from a co... Read more
Rash on torso (trunk); Chills; Very cold; Nauseated; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 08:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergic history.The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 09:00 as a single dose for COVID-19 immunisation Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, Concomitant medications included Trazodone 50mg (MANUFACTURER UNKNOWN) 2 tablets per day, Baby asprin (MANUFACTURER UNKNOWN), within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced chills, cold and nauseated. On 17Mar2021, the patient experienced rash on torso (trunk). Patient stated that after getting the 2nd dose, that evening patient started getting the chills and was very cold and felt like he had the flu. Patient also felt nauseated but did not throw up and took some Tylenol which helped but he did not check his temperature. Patient stated this lasted nearly 48 hours. On day 2 after getting the 2nd vaccine patient began getting a rash on his torso (trunk). It was mainly on the front side of his body but also some on back. The rash was fairly solid and looked like a sun burn. This lasted nearly a week with itching starting at about day 4 lasting about a full week from getting the 2nd dose. Patient was not feeling very well until about day 4 when he started getting energy to do things. At a week after patient pretty much back to normal. The clinical outcome of the events chills, cold, nauseated and rash on torso (trunk) was resolved on an unknown date in Mar2021.Patient has not tested positive for COVID-19 since having the vaccination. Information about lot/batch number cannot be obtained. No further information is expected.
62 2021-06-29 nerve pain Exacerbation of MS Symptoms. Including nerve pain and Cognitive difficulties along with heavy fatig... Read more
Exacerbation of MS Symptoms. Including nerve pain and Cognitive difficulties along with heavy fatigue.
62 2021-07-01 pain in extremity Fatigue and swelling with joint inflammation in left extremities. Follow-up for polyarthralgia Bri... Read more
Fatigue and swelling with joint inflammation in left extremities. Follow-up for polyarthralgia Brief history: Probable reactive arthritis: One week after getting second COVID vaccine (Pfizer, 5/3/2021) he developed chills, sweats, SOB, cough and red/watery eyes. Initially given topical antibiotics for eyes in walk in clinic. Went back and on 5/17/2021 given Medrol dose pack which cleared up symptoms. From 5/10/2021 onward he developed left shoulder soreness and limited ROM. He has had persistent polyarthralgia with morning stiffness. Seen initially in June 2021 with noted joint effusions in left elbow and left knee. Evaluation around that time significant for positive ANA (1:160, speckled), RF (22, normal < 14), SSB, Scl-70 (weakly positive). Other ENA panel and CCP negative. X-ray of left shoulder (6/3/2021) showed only mild degenerative changes suggestive that the limited ROM in shoulder is related to frozen shoulder. Rheum Medications: Celebrex 200mg daily Doxycycline 100mg daily (started about 2 weeks) Interval history: Patient was last seen 6/3/2021. He reports that the swelling in the left calf has decreased. The left knee has been bothering him. The mornings are the worse time of day. He continues to have swelling in the left knee. He has been doing ROM exercises with the left shoulder. At night he is not sleeping because of pain. He has morning stiffness which lasts from 20-30 minutes. He has noticed some pain in the left thumb. No eye pain/redness. No rashes. As in HPI, otherwise 12 point ROS was reviewed and negative
62 2021-07-01 tingling left leg and foot have tingled; semi-dizzy after the injection; involuntary bowel movement after inj... Read more
left leg and foot have tingled; semi-dizzy after the injection; involuntary bowel movement after injection.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in left arm on 17Mar2021 at 12:00, (at the age of 62-years) as single dose for COVID-19 immunisation. Medical history included C5, C6 quadriplegia and spinal cord injury in 1977. The patient did not have 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 received other unspecified medications within two weeks. The patient experienced left leg and foot have tingled, felt semi-dizzy after the injection, and I had an involuntary bowel movement moments after injection on 17Mar2021.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 left leg and food had tingled, felt semi-dizzy and had an involuntary bowel movement was unknown. No follow-up attempts are needed. No further information is expected.
62 2021-07-02 weakness faint; Soreness at injection site; chills; lethargy; body aches; weakness; Hypotension; This is a sp... Read more
faint; Soreness at injection site; chills; lethargy; body aches; weakness; Hypotension; This is a spontaneous report from a contactable consumer (patient reported himself). A 62-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 31May2021 at 10:15 AM (at the age of 62-year-old), as a single for covid-19 immunisation. The patient medical history included Coronary artery disease, CABG (Coronary artery bypass) surgery and hypertension. The patient had no known allergies. The patient received an unspecified concomitant medication within two weeks of vaccination. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 10May2021at 10:00 AM, as a single 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 did not have covid prior vaccination. The patient was not tested for covid-19 Since the vaccination. On 01Jun2021 at 09:00 AM, the patient experienced faint, soreness at injection site, chills, lethargy, body aches, weakness, and hypotension. Hypotension was continued to till the date. The patient visited physician office for the events. The treatment received for the adverse events was none. The patient was not resolved from all the events at the time of this report. Information on Lot/Batch number was available. Additional information has been requested.
62 2021-07-04 night sweats 63 year old male patient presents to ED 6/25/21 reporting 5 weeks of progressive cough, dyspnea and ...