chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; aches and pains; chest spasms; a fever a little shy of 101; hard to breathe; feel ill; activated all that discomfort; she thought she was having a heart attack; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 20Jan2021 12:30 at single dose in right arm to prevent covid. Vaccination Facility Type was Health department. Medical history included rotator cuff challenge. There were no concomitant medications. No other vaccine was administered on the same date. There were no prior vaccinations within 4 weeks and no adverse events were following prior vaccinations. Patient was calling about Pfizer Covid vaccine. She had the first shot on 20Jan2021. She did not have a reaction. She went to go get her monthly massage on Saturday (23Jan2021). On Sunday morning (24Jan2021) she started to feel ill and she had to go the hospital. She confirmed she was not admitted to the hospital. She had chills, aches and pains, it felt like an elephant was on her chest, she had chest spasms, a fever a little shy of 101. She went to hospital and the doctor there told her she had covid since she had all the symptoms. She confirmed she did not have covid and had a negative covid test. She had chest x-ray and an EKG since she thought she was having a heart attack. Reported her massage was primarily on her left shoulder, it was a deep massage on that area since she had a rotator cuff challenge, massage was focused on that shoulder. She was thinking that the vaccine activated all that discomfort since she felt it from the left part of shoulder, went down to her chest like a v, and back up to her right shoulder. Every time she took a breath she had a chest spasm and it was hard to breathe. The events required a visit to emergency room. For treatment, they gave her medication to take called robaxin, it was an anti-spasm, and 800mg of ibuprofen. She took robaxin Sunday night, Monday, and she took one on Tuesday since she was feeling better. She was sensitive to medication. She felt dizzy and nausea from Robaxin. The patient had recovered from the events completely by Wednesday on 27Jan2021. She had a reminder to return for the second dose on 10Feb2021. She was asking if she should get the second dose.   Information about Batch/Lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Rash, Tachycardia
Clinical narrative: body rash; tachycardic; near syncope; This is a spontaneous report from a contactable other health care professional (patient). A 45-year old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunisation at the hospital.  Medical history included asthma, clotting disorder and allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. However, it was reported that the patient had other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID019 prior to vaccination. The patient experienced body rash, tachycardia, near syncope on 20Jan2021. As a result, the patient went to the doctor office; clinic visit and emergency room/ department or urgent care. The patient received Cortisone injections, oral steroids and antihistamine in response to the events. The events were considered as non-serious by the reporter. The outcome of event recovering. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose of bnt162b2 (lot number: el3246, expiration date unknown) on 26Jan2021 at 9:30 AM via an unspecified route of administration on the left arm at a single dose for covid-19 immunization.   No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information received, the reported serious events of Generalized rash, Tachycardia and Pre-syncope were plausibly consequent to single dose for COVID-19 immunisation. The impact of this report on the benefit/risk of profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness postural, Dry mouth, Odynophagia, Shock symptom
Clinical narrative: Dizziness (like shock); Dizziness (like shock)/unable to stand or sit-up; Painful dry mouth and swallowing; Painful dry mouth and swallowing; Intense joint pain; This is a spontaneous report from a  contactable consumer reporting for herself.  A 65-years-old female patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EN5318) vaccine , via an unspecified route of administration in the left arm on 28Jan2021 14:15 at single dose for Covid-19 immunisation .  Medical history included systemic lupus erythematosus , Raynaud's phenomenon , intervertebral disc degeneration, arthritis , migraine , blood cholesterol increased , hypersensitivity.  Concomitant medication included atorvastatin calcium (LIPITOR), hydroxychloroquine sulfate (PLAQUENIL), estrogens conjugated (PREMARIN), rizatriptan benzoate (MAXALT), venlafaxine hydrochloride (EFFEXOR).  The patient experienced  dizziness (like shock)/unable to stand or sit-up on  28Jan2021 03:30 with outcome of recovering , painful dry mouth and swallowing on 28Jan2021 03:30 with outcome of recovering , intense joint pain on 28Jan2021 03:30 with outcome of recovering. The events Shock-like symptom and dizziness postural were considered Important Medical Events.  Since the vaccination,  the patient has not  been tested for COVID-19  Follow up information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neuropathy peripheral
Clinical narrative: increased (previously existing) neuropathy; continued fatigue; This is a spontaneous report from a contactable other healthcare professional reported that an elderly female patient of an unspecified age (current age: 90, unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Not available), second dose via intramuscular on 13Jan2021 at single dose for COVID-19 immunization in a nursing home/senior living facility. Medical history included ongoing neuropathy, Celiac disease, and allergies to gluten. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. No adverse events occurred with first dose. The patient was not pregnant at the time of vaccination. 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. In Jan2021, patient was experiencing continued fatigue and increased (previously existing) neuropathy, two weeks post second dose. However, onset date of the events was reported as 13Jan2021 (pending clarification). No treatment was received for the adverse events. Patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the possible contribution of suspect vaccine BNT162B2 to the event neuropathy peripheral 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Loss of consciousness, Night sweats
Clinical narrative: pass out; 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe/lower lumbar pain; dull headaches; Some night sweats; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265) on left arm intramuscularly from 28Jan2021 15:00 (03:00 PM) at single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), allergies to trees, pollen, grasses and latex. Concomitant medication included omeprazole (PRILOSEC), sucralfate (CARAFATE), sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL) , minerals nos/ vitamins nos (OPTISOURCE CHEWABLE VITAMIN & MINERAL SUPPLEMENT). There was no other vaccine in four weeks. The patient historical vaccine included bnt162b2 (lot number: EL1284) for first dose on 04Jan2021, 03:00 PM, Intramuscularly, left arm, for covid-19 immunisation. The patient previously took metoclopramide (REGLAN), pethidine hydrochloride (DEMEROL) and hydrochlorothiazide (HCTZ) and all had allergies. On 29Jan2021, 02:00 AM, 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe it caused me to pass out. In Jan 2021, 20 hours to 48 hours post injection continued to have dull headaches and lower lumbar pain achy at this point. Some night sweats. The vaccination facility type is hospital. There was no covid prior vaccination and covid tested post vaccination. There was no treatment for the events. The events were not result in emergency room visit or physician office visit. The outcome the events recovered in Jan2021.; Sender's Comments: Based on the compatible time association, the event back pain and loss of consciousness are possibly related to suspect vaccine BNT162B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Diarrhoea, Dizziness, Eye movement disorder
Clinical narrative: Diarrhea began about 2 hours after inject as well as fever; Diarrhea began about 2 hours after inject as well as fever; BP had increased to 170s SBP and 120s DBP; Experienced a near syncopal episode; Dizzy/Light headed; Eyes were fluttering; Nausea; Vomiting; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received second dose of BNT162B2, via intramuscular in left arm on 29Jan2021 08:30 am at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included PCOS. Concomitant medication included celecoxib (CELEXA [CELECOXIB]), buspirone hydrochloride (BUSPAR). The patient previously took keflex [cefalexin] and cipro [ciprofloxacin] and experienced Known allergies: Cipro and Keflex. Historical vaccine of BNT162B2 at 25 year on 08Jan2021 for covid-19 immunisation. The patient stated on 29Jan2021 10 minutes post vaccine at 08:45 am she became lightheaded and dizzy. It was reported that her eyes were fluttering and experienced a near syncopal episode. Further assessment showed that her BP had increased to 170s SBP and 120s DBP. Her baseline SBP was 1-teens and 1-tens. She also experienced nausea and vomiting at that time. She was taken to ER for cardiac monitoring and eval. BP returned to normal spontaneously. Diarrhea began about 2 hours after inject as well as fever. Highest fever noted was 102.3. Discharged home from ER. Symptoms has subsided 24hrs post vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: increased to 170s sbp and 120s dbp on 29Jan2021, blood pressure measurement: normal on 2021, body temperature: 102.3 on 29Jan2021. The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been not been tested for COVID-19. The adverse events resulted in emergency room. No treatment was received for the adverse events. The outcome of the events recovered on an unspecified date of 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the event blood pressure high 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.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Nausea, Presyncope, Pyrexia, Vomiting
Clinical narrative: Diarrhea began about 2 hours after inject as well as fever; Diarrhea began about 2 hours after inject as well as fever; BP had increased to 170s SBP and 120s DBP; Experienced a near syncopal episode; Dizzy/Light headed; Eyes were fluttering; Nausea; Vomiting; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received second dose of BNT162B2, via intramuscular in left arm on 29Jan2021 08:30 am at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included PCOS. Concomitant medication included celecoxib (CELEXA [CELECOXIB]), buspirone hydrochloride (BUSPAR). The patient previously took keflex [cefalexin] and cipro [ciprofloxacin] and experienced Known allergies: Cipro and Keflex. Historical vaccine of BNT162B2 at 25 year on 08Jan2021 for covid-19 immunisation. The patient stated on 29Jan2021 10 minutes post vaccine at 08:45 am she became lightheaded and dizzy. It was reported that her eyes were fluttering and experienced a near syncopal episode. Further assessment showed that her BP had increased to 170s SBP and 120s DBP. Her baseline SBP was 1-teens and 1-tens. She also experienced nausea and vomiting at that time. She was taken to ER for cardiac monitoring and eval. BP returned to normal spontaneously. Diarrhea began about 2 hours after inject as well as fever. Highest fever noted was 102.3. Discharged home from ER. Symptoms has subsided 24hrs post vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: increased to 170s sbp and 120s dbp on 29Jan2021, blood pressure measurement: normal on 2021, body temperature: 102.3 on 29Jan2021. The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been not been tested for COVID-19. The adverse events resulted in emergency room. No treatment was received for the adverse events. The outcome of the events recovered on an unspecified date of 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the event blood pressure high 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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Echocardiogram, Magnetic resonance imaging, White matter lesion
Clinical narrative: stroke; Extensive FLAIR hyperintense signal signal in the cerebral white matter/ Mild hyperintense signal in the brain stem and medial cerebellum; This is a spontaneous report from a contactable consumer. This consumer reported for a 76-year-old female patient (reporter's mother) who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302) first dose via unspecified route of administration on 21Jan2021 at 12:00 PM in left arm at single dose for COVID-19 Immunization in the hospital. There was no other vaccine administered in four weeks. Medical history included COPD (Chronic obstructive pulmonary disease), Small Cell Lung Carcinoma with metastases to brain s/p surgery, chemotherapy and radiation in 2014, dementia. Concomitant medications included citalopram at 40mg, levothyroxine at 0.05 mg, salbutamol (ALBUTEROL). The patient previously took Codeine and experienced allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient had what appeared to be a stroke on Saturday, 23Jan2021 at 12:00 PM. A CT, MRI and an Echocardiogram were all performed on 23Jan2021 and there was no acute intracranial hemorrhage, mass effect, midline shift, or extra-axial fluid collection. Extensive FLAIR hyperintense signal signal in the cerebral white matter. Mild hyperintense signal in the brain stem and medial cerebellum. Following contrast administration there is no abnormal CNS enhancement. The adverse events resulted in Emergency room/department or urgent care and hospitalization for seven days from Jan2021. Treatment given was TPA to reverse adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was recovered/resolved with sequel.  No follow-up attempts possible. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 07Jan2021, 15:00 (lot number: EL3246), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the hospital. The patient's medical history included Covid-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient experienced sore throat, nausea, palpitations, headaches, dizziness, fatigue, faint, cough, body aches and myalgia on 08Jan2021, 19:00. The adverse events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient received treatment including antibiotics (did not help); pain medications for myalgia. The patient was underwent COVID-19 (Nasal Swab) on 15Jan2021 which was negative, and PCR and Flu (nasal swab) test on 20Jan2021 which was negative. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Palpitations, SARS-CoV-2 test
Clinical narrative: sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 07Jan2021, 15:00 (lot number: EL3246), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the hospital. The patient's medical history included Covid-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient experienced sore throat, nausea, palpitations, headaches, dizziness, fatigue, faint, cough, body aches and myalgia on 08Jan2021, 19:00. The adverse events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient received treatment including antibiotics (did not help); pain medications for myalgia. The patient was underwent COVID-19 (Nasal Swab) on 15Jan2021 which was negative, and PCR and Flu (nasal swab) test on 20Jan2021 which was negative. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 07Jan2021, 15:00 (lot number: EL3246), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the hospital. The patient's medical history included Covid-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient experienced sore throat, nausea, palpitations, headaches, dizziness, fatigue, faint, cough, body aches and myalgia on 08Jan2021, 19:00. The adverse events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient received treatment including antibiotics (did not help); pain medications for myalgia. The patient was underwent COVID-19 (Nasal Swab) on 15Jan2021 which was negative, and PCR and Flu (nasal swab) test on 20Jan2021 which was negative. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Body temperature, Burning sensation, Laboratory test
Clinical narrative: tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertips and toes were very painful-burning sensation; fingertips and toes were very painful-burning sensation; Underarm pain-throbbing; skin hurt when applying lotion; Low grade fever 99.9; This is a spontaneous report from a contactable other healthcare professional (patient).  A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262), intramuscularly at right arm on 29Jan2021 11:00 at single dose for COVID-19 immunization at workplace clinic. The patient's medical history included autoimmune disorder, kidney disease, angina, and high blood pressure. There were other medications that the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies: Simvastatin, Tramadol, Codeine. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), at the age of 62-year-old, intramuscularly at right arm on 09Jan2021 13:15 at single dose for COVID-19 immunization at workplace clinic. It was reported that on the 2nd day after the vaccine (30Jan2021 13:00) patient started having body aches, muscle pain, joint pain, nerve pain. Her fingertips and toes were very painful-burning sensation. Also reported underarm pain-throbbing. Her skin hurt when applying lotion. Had low grade fever 99.9. Treatment was received for the above mentioned events: Tylenol 500mg, 2 Caps Q6h. Patient was recovering from the above mentioned events. She do have an autoimmune disorder: her Rheumatologist is checking for Psoriatic arthritis. She had tested positive for Rheumatoid Arthritis (unknown outcome). No treatment for this condition at this time. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 or not prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuralgia, Pain, Pain in extremity, Pain of skin
Clinical narrative: tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertips and toes were very painful-burning sensation; fingertips and toes were very painful-burning sensation; Underarm pain-throbbing; skin hurt when applying lotion; Low grade fever 99.9; This is a spontaneous report from a contactable other healthcare professional (patient).  A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262), intramuscularly at right arm on 29Jan2021 11:00 at single dose for COVID-19 immunization at workplace clinic. The patient's medical history included autoimmune disorder, kidney disease, angina, and high blood pressure. There were other medications that the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies: Simvastatin, Tramadol, Codeine. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), at the age of 62-year-old, intramuscularly at right arm on 09Jan2021 13:15 at single dose for COVID-19 immunization at workplace clinic. It was reported that on the 2nd day after the vaccine (30Jan2021 13:00) patient started having body aches, muscle pain, joint pain, nerve pain. Her fingertips and toes were very painful-burning sensation. Also reported underarm pain-throbbing. Her skin hurt when applying lotion. Had low grade fever 99.9. Treatment was received for the above mentioned events: Tylenol 500mg, 2 Caps Q6h. Patient was recovering from the above mentioned events. She do have an autoimmune disorder: her Rheumatologist is checking for Psoriatic arthritis. She had tested positive for Rheumatoid Arthritis (unknown outcome). No treatment for this condition at this time. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 or not prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rheumatoid arthritis
Clinical narrative: tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertips and toes were very painful-burning sensation; fingertips and toes were very painful-burning sensation; Underarm pain-throbbing; skin hurt when applying lotion; Low grade fever 99.9; This is a spontaneous report from a contactable other healthcare professional (patient).  A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262), intramuscularly at right arm on 29Jan2021 11:00 at single dose for COVID-19 immunization at workplace clinic. The patient's medical history included autoimmune disorder, kidney disease, angina, and high blood pressure. There were other medications that the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies: Simvastatin, Tramadol, Codeine. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), at the age of 62-year-old, intramuscularly at right arm on 09Jan2021 13:15 at single dose for COVID-19 immunization at workplace clinic. It was reported that on the 2nd day after the vaccine (30Jan2021 13:00) patient started having body aches, muscle pain, joint pain, nerve pain. Her fingertips and toes were very painful-burning sensation. Also reported underarm pain-throbbing. Her skin hurt when applying lotion. Had low grade fever 99.9. Treatment was received for the above mentioned events: Tylenol 500mg, 2 Caps Q6h. Patient was recovering from the above mentioned events. She do have an autoimmune disorder: her Rheumatologist is checking for Psoriatic arthritis. She had tested positive for Rheumatoid Arthritis (unknown outcome). No treatment for this condition at this time. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 or not prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and 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.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Feeling abnormal, Hallucination
Clinical narrative: a specific disease where things in time-space was not adding up/something not right with time frame; having bouts, what the reporter  thinks are slight hallucinations; "floaty" feeling/ feeling of being "trapped" as he was trying to exit the latrine; This is a spontaneous report from a contactable consumer reported for her husband.  A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration at left arm on 27Jan2021 13:15 at single dose for COVID-19 immunization. Facility where the COVID-19 vaccine was administered: Other. The patient's medical history included stroke, blood pressure high (HBP), diabetes (Non-Insulin Dependent) and known allergies to medications, food, or other products: Lisinopril, Penicillin. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril and experienced drug allergy. The reporter's husband (for whom she was reporting) had been having bouts, what she thought are slight hallucinations, since receiving the vaccine. The first (onset of bouts) was twenty-four hours later (28Jan2021) when he described a "floaty" feeling in the morning and was not wanting to get out of bed. Second was forty-eight hours later, on the 29Jan2021, in the morning when he had (as with routine), left his empty water pitcher out for refill (which was per normal), he proceeded to question her about what happened to it and was stating that something was not right with the time frame of events. Thirdly, he had a feeling of being "trapped" as he was trying to exit the latrine on the 31Jan2021 (early hours of the morning). He at that point referenced a specific "disease" where things in time-space was not adding up. Before the vaccine, he was doing fine. After receiving this first dose, it seems to the reporter that he was suffering a reaction contrary to the general side effects. No treatment was received for the events. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Generalised tonic-clonic seizure, Myoclonus
Clinical narrative: Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EN5318) via an unspecified route of administration on 30Jan2021 12:45 into right arm at a single dose for COVID-19 immunisation. The patient medical history included epilepsy and cerebral palsy and known allergies is to amoxicillin. The patient had a seizure disorder, epilepsy (Lennox Gastaut Syndrome). He has an average of 1 Tonic-Clonic (Grand Mal) and 2 Series of Myoclonic Jerks a day. There is no other vaccine was administered in four weeks. There is no COVID prior to vaccination. Concomitant medications in two weeks included topiramate (TOPAMAX), lamotrigine (LAMICTAL), clobazam (ONFI), glycopyrronium bromide (CUVPOSA), potassium citrate, citric acid, calcium carbonate and colecalciferol (VITAMIN D). Within the first 24 hours(PENDING CLARIFICATION, as reported as 30Jan2021 02:45AM) of receiving the vaccine his seizure activity increased. Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks. The patient received emergency seizure medicine Klonopin. The patient did not test COVID post vaccination. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Immunosuppression
Clinical narrative: very suppressed immune system; have a problem with her hearing; This is a spontaneous report from a contactable consumer. A 58-years-old female patient (Reporter sister) received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation.  The patient medical history included down syndrome. Concomitant medications were not reported. It was reported, the 75 female consumer, her husband (78 years), and her sister (58 years) received their first COVID vaccine in (State name) 3 weeks ago. They moved to (city name) and there is no place in (city name) that will give them their second dose. Caller is wondering if it is advisable to skip the second dose or is it possible to start all over and get the first dose again when they can schedule 2nd dose. Caller stated her and her husband did not have any side effects after receiving the first dose, but her sister (58 years) who has a very suppressed immune system and has down syndrome began to have a problem with her hearing at about the 2 week mark after receiving the first dose of the vaccine. They were trying to determine what was going on as it was a sudden onset and made an appointment with a hearing specialist. The outcome of the events was unknown.  No follow-up attempts are possible, information on batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Chest X-ray, Chest discomfort, Drug ineffective, SARS-CoV-2 test
Clinical narrative: First time having COVID symptoms; tested positive; First time having COVID symptoms; tested positive; COVID symptoms started on day 7 including loss of smell.; Horrible chest pressure 3 days after vaccination.; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in left arm on 15Jan2021 15:30 at single dose for Covid-19 immunization. Medical history was not reported. Concomitant medications included progesterone and estradiol. The patient was not Pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no Allergies to medications, food, or other products. The patient had Horrible chest pressure 3 days after vaccination (18Jan2021 07:00). COVID symptoms started on day 7 (22Jan2021) including loss of smell. First time having COVID symptoms; Nasal Swab tested positive on 26Jan2021. The patient was unknown if diagnosed with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 Since the vaccination. The events resulted Doctor or other healthcare profession-al office/clinic visit. Treatment received for all events included Chest xray. The outcome of all events was resolving.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: First time having COVID symptoms; tested positive; First time having COVID symptoms; tested positive; COVID symptoms started on day 7 including loss of smell.; Horrible chest pressure 3 days after vaccination.; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in left arm on 15Jan2021 15:30 at single dose for Covid-19 immunization. Medical history was not reported. Concomitant medications included progesterone and estradiol. The patient was not Pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no Allergies to medications, food, or other products. The patient had Horrible chest pressure 3 days after vaccination (18Jan2021 07:00). COVID symptoms started on day 7 (22Jan2021) including loss of smell. First time having COVID symptoms; Nasal Swab tested positive on 26Jan2021. The patient was unknown if diagnosed with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 Since the vaccination. The events resulted Doctor or other healthcare profession-al office/clinic visit. Treatment received for all events included Chest xray. The outcome of all events was resolving.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Inappropriate schedule of product administration, Meningeal disorder, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: autoimmune meningeal reaction/Prolonged headache; autoimmune meningeal reaction/Prolonged headache; Date of start of drug 14Jan2021/ Date of start of drug 22Dec2020; This is a spontaneous report from a contactable physician. A 37-year-old female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982) intramuscular at left arm on 14Jan2021 09:00 AM at single dose for COVID-19 immunization in hospital. Medical history was none. No known allergy. No covid prior vaccination. Patient is not pregnant. Concomitant mediations were not reported. Patient previously received the first dose of BNT162B2 (lot number: EJ1685) intramuscular at left arm on 22Dec2020 11:00 AM at single dose for COVID-19 immunization. Concomitant medication was none (No other vaccine in 4 weeks, no other medications in two weeks). Patient experienced prolonged headache, seen by PCP and neurologist who diagnosed with autoimmune meningeal reaction on 14Jan2021 09:00PM. Prescribed steroids, waiting for response. event resulted in Doctor or other healthcare professional office/clinic visit. Lab test included PCR and Nasal Swab, both on 05Jan2021 with result negative. Outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event autoimmune/meningeal disorder 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Pruritus, Rash, Swelling
Clinical narrative: bruise to her back; rash on back of neck/rash all over her body; redness; swollen area back of neck/ swollen area to her back; a lot itchier; This is a spontaneous report from a contactable Nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via intramuscular on left deltoid on 21Jan2021 at 14:00 at single dose to prevent Covid 19. The relevant medical history included obese from an unspecified date. Concomitant medications were reported as none. The patient experienced rash on back of neck/rash all over her body on 26Jan2021 at 19:30, swollen area back of neck/ swollen area to her back on 26Jan2021 at 10:00, redness on 26Jan2021 at 19:30, bruise to her back on 27Jan2021 at 10:00, a lot itchier in Jan2021. The nurse stated that she wanted to report that she had the Pfizer vaccine last Thursday. Stated that two days prior to the report that a rash started on the back of her neck and stated yesterday it was a lot itchier (as reported). Stated that she got undressed to put her PJs on and noticed that she had a fine raised rash everywhere and it was swollen. Stated that she went through her house to see if there was anything that could have caused it. Stated that she went to that doctor at the time of the report and was started on Prednisone taper. Stated that the doctor was concerned about the Prednisone reducing her ability to prevent antibodies. Stated that the doctor stated that he was unsure if she should get the second dose. Caller wanted to ask questions about these things. Had not started the Prednisone yet. Stated that there was redness to the back of her neck and back. Stated that the swelling was to the back of her neck and back. The events did not require a visit to Emergency Room but required a visit to Physician Office. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The event bruise to her back was reported as non-serious, while the events rash on back of neck/rash all over her body, swollen area back of neck/ swollen area to her back and redness were reported as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "rash on back of neck/rash all over her body", "swollen area back of neck/ swollen area to her back and redness" and the administration of the COVID-19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.