chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Retching, Vomiting
Clinical narrative: heart attack; became ill; I became nauseous; vomiting; dry heaves; dizzy; tingling in my face and right hand; right hand didn't feel like I could get up on my own; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 10Feb2021 10:15 at SINGLE DOSE in left arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) with lot number: EL3249 on 20Jan2021 in right arm. After receiving the 2nd dose on 10Feb2021, the patient became ill on 11Feb2021, while sitting on the toilet, she became nauseous and vomiting repeatedly even dry heaves also then became dizzy and felt a tingling in my face and right hand didn't feel like the patient could get up on her own so the patient's son and daughter assisted her to her bed. She didn't know what was wrong and her daughter thought it was a side effect of the vaccine and called the nurse on call. After arriving at the emergency and was examined the patient was told she was being kept for observation since she had just had the vaccine. The patient was later told she also had a mild heart attack and to her knowledge I never had any heart issues. She could then no longer use her walker to walk because she couldn't bear weight on her right hand. She was hospitalized for 8 days and transferred to rehab and I'm still in rehab. The events were assessed as serious (hospitalized and disability). The outcome of the events was not recovered. The patient received treatment for the events.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fall, Hyperhidrosis, Loss of consciousness, Muscular weakness
Clinical narrative: blacked out; Nausea; chills; sweating; muscle weakness; arm pain; fever; fell; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN5318) via an unspecified route of administration on Right arm, at the age of 32-year-old, on 27Feb2021 13:15, single dose, for covid-19 immunisation.  Medical history included gastrooesophageal reflux disease.  Concomitant medication included esomeprazole magnesium (ESOMEPRAZOLE [ESOMEPRAZOLE MAGNESIUM]) and garlic supplement.  The patient previously took amoxicillin and experienced drug hypersensitivity and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6198) on 06Feb2021 13:15, at right arm, at the age of 32-year-old single dose for covid-19 immunisation.  On 28Feb2021 at 04:00, 15 hours after the shot was administered, the patient experienced nausea, chills, sweating, muscle weakness, arm pain, fever, fell and blacked out twice. The patient did not receive any treatment in response to the events. The patient was not diagnosed with covid prior vaccination and was not tested for COVID post vaccination. Outcome of the events was recovering at the time of the report.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported loss of consciousness cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: blacked out; Nausea; chills; sweating; muscle weakness; arm pain; fever; fell; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN5318) via an unspecified route of administration on Right arm, at the age of 32-year-old, on 27Feb2021 13:15, single dose, for covid-19 immunisation.  Medical history included gastrooesophageal reflux disease.  Concomitant medication included esomeprazole magnesium (ESOMEPRAZOLE [ESOMEPRAZOLE MAGNESIUM]) and garlic supplement.  The patient previously took amoxicillin and experienced drug hypersensitivity and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6198) on 06Feb2021 13:15, at right arm, at the age of 32-year-old single dose for covid-19 immunisation.  On 28Feb2021 at 04:00, 15 hours after the shot was administered, the patient experienced nausea, chills, sweating, muscle weakness, arm pain, fever, fell and blacked out twice. The patient did not receive any treatment in response to the events. The patient was not diagnosed with covid prior vaccination and was not tested for COVID post vaccination. Outcome of the events was recovering at the time of the report.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported loss of consciousness cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis, SARS-CoV-2 test
Clinical narrative: I have MS and after day 4 of the 2nd dose I haven't been the same.; This 65- year-old male patient contactable consumer (reported for himself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EL9264), via an unspecified route of administration, on 13Feb2021 at 11:00 AM as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Nursing Home/Senior Living Facility. Historical Vaccine included first dose of BNT162B2 on 23Jan2021 for COVID-19 immunization, lot number 11:00 AM, in left arm. She has had no other vaccines on the same day or in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included: Multiple Sclerosis, colitis, gastroparesis, asthma, and allergy to Penicillins. Concomitant medications were not reported. It was also warm to the touch. On 17Feb2021, the patient reported that I have MS and after day 4 of the 2nd dose I haven't been the same. Pain throughout my body and extreme fatigue. All my MS issues were brought to light and haven't left. The outcome of the events Pain throughout my body and extreme fatigue/ MS issues were brought to light and haven't left was not recovered. It was reported that since the vaccination, the patient had been tested for COVID-19 via nasal swab on 19Feb2021 with a negative result.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19 test (nasal swab) on 29Jan2021 and the result was positive; covid-19 test (nasal swab) on 29Jan2021 and the result was positive; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, the first dose on 24Dec2020 14:15 (lot number: EKT231) on the left arm, then the second dose on 14Jan2021 (lot number: unknown) on the left deltoid; both at a single dose for COVID-19 immunization. The patient experienced severe abdominal pain, clay colored stool, tea colored urine, intensely burning, exploding headache and productive cough after the first dose was administered on 24Dec2020. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient underwent covid-19 test (nasal swab) on 29Jan2021 and the result was positive. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm pain; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EM, expiration date unknown) via an unspecified route of administration in the left arm on 05Feb2021 13:30 (at 70 years old) at a SINGLE DOSE for COVID-19 immunisation. The patient's medical history included bulging discs and known allergies to Penicillin, Dilaudid, and Sulphur.  Concomitant medications included ascorbic acid (VITAMIN C), colecalciferol (D), biotin, calcium, magnesium, and curcuma longa (TURMERIC); all from an unknown date for unspecified indications. The patient received these medications within 2 weeks of vaccination. At 70 years old, the patient received the first dose of BNT162B2 (lot number: EM, expiration date unknown) via an unspecified route of administration in the left arm on 15Jan2021 11:30 at a single dose for COVID-19 immunisation and experienced pain in left knee and down to ankle and knee arthritic. The patient was not pregnant at the time of vaccination; was not diagnosed with COVID prior to vaccination; did not receive any other vaccines within 4 weeks prior to BNT162B2; and has not been tested for COVID post vaccination. It was reported that after the administration of the second dose, the patient experienced left arm pain on an unspecified date. Patient realized that the pain was akin to what she felt in knee (after the first dose) but not as bad. No treatment was received in response to the event. Outcome of the event was recovered with sequelae. The event was reported as disabling.  Information on batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Reporter could not wake patient up; Oxygen dropped; Not doing too good; This is a spontaneous report from a contactable consumer (patient's wife).  A male patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 Vaccine. Medical history included lung cancer (they just told him he has lung cancer), ongoing smokes (She reported that he still smokes). The patient's concomitant medications were not reported. Consumer reported her husband was administered the first dose of Pfizer COVID-19 Vaccine. He refused to take the second dose of Pfizer COVID-19 Vaccine because he is not doing too good; and because of the events he experienced after being administered the first dose of Pfizer COVID-19 Vaccine. She clarified that the events he experienced after being administered the first dose of Pfizer COVID-19 Vaccine included: Right after the first dose of the vaccine was administered she does not know what happened but his oxygen dropped; that happens too because he won't wear his oxygen like he should; but reporter could not wake him up so he had to go to the hospital. The patient underwent lab tests and procedures which included oxygen saturation: dropped on unknown date. Therapeutic measures were taken as a result of oxygen dropped. The outcome of the events was unknown.    Information about lot/batch number has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Palpitation; This is a spontaneous report from a contactable consumer (patient). This 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on 27Feb2021 at single dose for COVID-19 immunization. Medical history included AFib (atrial fibrillation). Concomitant medications included apixaban (ELIQUIS) as blood thinners, had been fine with apixaban, had not got no problem with it; carvedilol (the patient took carvedilol and apixaban before got vaccine and at night of 27Feb2021 when the patient went to bed). Patient got a shot in the afternoon of 27Feb2021, and the night the patient had some palpitations, she was wondering about that because they didn't ask the patient anything about the heart. The patient did take blood thinners apixaban and carvedilol. The patient's question was should she get the second shot, well do the first vaccine have the same ingredients as the first? She was just concerned because she had history of AFib. Outcome of the event was unknown.  Information about lot/batch number was requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Entire left side went numb for 8 min; This is a spontaneous report from a contactable consumer (reported for herself, not pregnant). A 38-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration on 26Feb2021 14:00 at single dose in left arm for COVID-19 immunisation. The patient's medical history included known allergies Sulfur. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Health Clinic facility. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient experienced Entire left side went numb for 8 min on 01Mar2021 10:30. No treatment was received for the adverse event. The adverse event result in Doctor or other healthcare professional office/clinic visit. The event was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the event was recovering.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable other HCP (patient). A 63-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 18Dec2020 at SINGLE DOSE at left deltoid for covid-19 immunisation. Medical history included hot flushes from an unknown date, MCI from an unknown date. The patient's father had medical history of diabetic-II, obesity, the patient's siblings had medical history of environmental allergies, pre-diabetic, obesity. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) from 2005 and ongoing at 150 mg daily for hot flashes, curcuma longa (TURMERIC) from 2018 and ongoing at 1 tablet twice a day for MCI. The patient experienced fatigue on an unspecified date. The outcome was unknown. The reporter considered the Pfizer product had a causal effect to the adverse event.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: caught COVID (approximately five days after vaccine). Tested positive 10 days after vaccination; This is a spontaneous report from a contactable consumer (patient himself). A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269), via an unspecified route of administration in the left arm on 12Feb2021 at 16:30 (04:30 PM) at single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. The patient had no COVID prior to vaccination. There were no concomitant medications. The patient had no other vaccine in four weeks and had no other medications in two weeks. On 17Feb2021, the patient caught COVID (approximately five days after vaccine). Tested positive 10 days after vaccination on 21Feb2021. The patient had a COVID test post vaccination which included an Oral Swab with Positive result on 22Feb2021. The patient had not received any treatment. The outcome of the event was resolved on an unspecified date in 2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Lymph node pain, Nerve compression, Neuralgia, Pain
Clinical narrative: significant pain in right armpit lymph node area; Severe nerve pain throughout right upper quadrant of my body, in arm and back (spine); Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; occasional heat sensation; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female non-pregnant patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration on 26Feb2021 17:30 at single dose in Right arm for COVID-19 immunisation. There was no medical history, no Allergies to medications, food, or other. Concomitant medication included metformin, fish oil, colecalciferol (D3) within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) at the age of 42-year-old, on 29Jan2021 17:30 at single dose in Left arm for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe nerve pain throughout right upper quadrant of her body, in arm and back (spine), began the afternoon the day after the second shot on 27Feb2021 03:00 PM and progressed throughout the day, until almost unbearable that evening, even with 800mg ibuprofen.  Pain was similar to pinched nerves, with pain, tingling, occasional heat sensation, as opposed to that of a pulled or sore muscle. The patient could not lay in bed that evening and had to sleep upright in a chair with a pillow under her elbow to get minor relief. This pain continued on day 3, but was starting to lessen slightly. Day 2 (28Feb2021), the patient also developed significant pain in right armpit lymph node area, becoming more intense on day 3. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of "severe nerve pain throughout right upper quadrant of my body, in arm and back (spine)", "pain similar to pinched nerves, with pain, tingling" which included 800mg ibuprofen. There was no treatment received for the remaining events. The outcome of the events was unknown. The events were reported as non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: significant pain in right armpit lymph node area; Severe nerve pain throughout right upper quadrant of my body, in arm and back (spine); Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; occasional heat sensation; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female non-pregnant patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration on 26Feb2021 17:30 at single dose in Right arm for COVID-19 immunisation. There was no medical history, no Allergies to medications, food, or other. Concomitant medication included metformin, fish oil, colecalciferol (D3) within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) at the age of 42-year-old, on 29Jan2021 17:30 at single dose in Left arm for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe nerve pain throughout right upper quadrant of her body, in arm and back (spine), began the afternoon the day after the second shot on 27Feb2021 03:00 PM and progressed throughout the day, until almost unbearable that evening, even with 800mg ibuprofen.  Pain was similar to pinched nerves, with pain, tingling, occasional heat sensation, as opposed to that of a pulled or sore muscle. The patient could not lay in bed that evening and had to sleep upright in a chair with a pillow under her elbow to get minor relief. This pain continued on day 3, but was starting to lessen slightly. Day 2 (28Feb2021), the patient also developed significant pain in right armpit lymph node area, becoming more intense on day 3. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of "severe nerve pain throughout right upper quadrant of my body, in arm and back (spine)", "pain similar to pinched nerves, with pain, tingling" which included 800mg ibuprofen. There was no treatment received for the remaining events. The outcome of the events was unknown. The events were reported as non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: red blotch - broken blood vessel on white of right eye; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El9266) on left arm, via an unspecified route of administration on 22Feb2021 18:00 at single dose for COVID-19 immunisation. Medical history included COVID from an unspecified date (if COVID prior vaccination: yes). The patient's concomitant medications were not reported. The patient experienced red blotch - broken blood vessel on white of right eye on 23Feb2021 07:00. The patient had no other vaccine in four weeks. The patient was not COVID tested post vaccination. There was no treatment received for the adverse event. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: abnormal period approximately 1 week after 1st vaccine on 20Feb2021. Period was not due for another 3 weeks. Very heavy clotting and flow.; TThis is a spontaneous report from a non-contactable consumer (patient). This 46-year old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9266) at single dose via an unknown route in left arm on 11Feb2021 17:15 for Covid-19 immunization. Medical history was not provided. Patient had no covid prior vaccination. Patient was not pregnant. Concomitant drugs administered in two weeks included estradiol and escitalopram. There was no other vaccine in four weeks. Patient experienced abnormal period approximately 1 week after 1st vaccine on 20Feb2021. Period was not due for another 3 weeks. Very heavy clotting and flow. No treatment received for the event. Covid test post vaccination included nasal swab which was negative. Outcome of the event was resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Blood pressure diastolic, Blood pressure systolic, Dizziness, Dyspnoea, Investigation
Clinical narrative: increased shortness of breath; dizziness; This is a spontaneous report from a contactable consumer based on information received by Pfizer (manufacturer control number: EC-2021-087780), for bnt162b2.   A 75-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation; lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 14Jan2021 to an unspecified date at 14 mg daily for an unspecified indication; levothyroxine sodium, via an unspecified route of administration from an unknown date to an unknown date at 75 mcg once daily for an unspecified indication. Medical history included endometrial carcinoma as diagnosis C54.1, small bowel obstructions. The patient's concomitant medications were not reported. The patient previously took keytruda. Patient received first COVID vaccine this week and experience dizziness for 24 hours but has since resolved. Scheduled to receive second vaccine on 12Mar2021. Noted with increased shortness of breath with activity lasting longer than 10-15 minutes. Patient believe this is attributed to increase in thyroid and blood pressure medication more so than the Lenvima. Levothyroxine was increased to 75 mcg once daily. Scheduled for repeat labs and Keytruda infusion on 10Mar2021. Stated will discuss with oncologist at that time. Patient stated systolic blood pressure remains in 130s, but diastolic blood pressure remains in 90s. Continues to monitor and record and will discuss with oncologist on 10Mar2021. Most recent labs indicated CA125 levels decreased from 340 to 73. Stated oncologist is pleased with her progress. Scheduled for repeat scan at end of March. The patient underwent lab tests and procedures which included blood pressure diastolic: 90s on an unknown date, blood pressure systolic: 130s on an unknow date, CA125 levels: decreased from 340 to 73 on an unknown date.  The action taken in response to the event for lenvatinib mesilate and levothyroxine sodium was unknown. Outcome of the event dizziness was recovered, outcome of the event increased shortness of breath was unknown.  Pfizer is a marketing authorization holder of levothyroxine sodium in the country of incidence. This may be a duplicate report if another marketing authorization holder of levothyroxine sodium has submitted the same report to the regulatory authorities.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EL8982), via an unspecified route of administration in left deltoid, on 28Jan2021 at 11:45 AM, at single dose, for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included losartan (unknown manufacturer) from 2009 and ongoing, alopurinol (unknown manufacturer) from 1980 and ongoing, omeprazole (unknown manufacturer) from 2012 and ongoing, amlodipine besilate (unknown manufacturer) from 2010 and ongoing, cetirizine hydrochloride (CETIRIZINE) from 1998 and ongoing, atorvastatin calcium (unknown manufacturer) from 2019 and ongoing. The patient previously took the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# EJ1686) on 04Jan2021 at 03:00 PM, for COVID-19 immunisation and experienced mild soreness/arm sore/soreness in the arm and fatigue. Previously the patient received 1 pill of naproxen sodium (ALEVE) on 04Jan2021 to anticipate fever and pain. The patient experienced fatigue (non-serious) on 28Jan2021 with outcome of recovered in 2021. No therapeutic measures were taken as a result of the event.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Contusion, Diarrhoea, Dizziness, Fatigue
Clinical narrative: unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypotension, Nausea, Pain in extremity
Clinical narrative: unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, SARS-CoV-2 test
Clinical narrative: unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Lethargy, Multiple sclerosis, SARS-CoV-2 test
Clinical narrative: Patient has MS and UC - weeks of lethargy; Patient has MS and UC - weeks of lethargy; lethargy; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Feb2021 01:00 PM at single dose for COVID-19 immunisation.  Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient was not pregnant. Patient has MS (multiple sclerosis) and UC (ulcerative colitis) - weeks of lethargy on Feb2021. AE resulted in doctor or other healthcare professional office/clinic visit. Unknown if treatment received. The patient underwent lab tests and procedures which included SARS-CoV-2 test: COVID yes prior vaccination. Events outcome was recovering.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL9269), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that the patient had an attack of bell's palsy on an unspecified date. Outcome of the event was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Rash macular, Skin discolouration
Clinical narrative: Covid Toes. Red and purple discoloration spots on distal tip of big toe L foot and red spot dorsum of second toe; Covid Toes. Red and purple discoloration spots on distal tip of big toe L foot and red spot dorsum of second toe; Covid Toes. Red and purple discoloration spots on distal tip of big toe L foot and red spot dorsum of second toe; This is a spontaneous report from a contactable consumer reported for himself.  A 73-year-old male patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9261), at the age of 73-year-old via an unspecified route of administration in Right arm on 05Feb2021 15:00 at single dose for covid-19 immunisation.  Medical history included hypertension, asthma, pulmonary embolism, elevated cholesterol, Peanut allergy.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included warfarin, atenolol, simvastatin.  The patient experienced Covid Toes, red and purple discoloration spots on distal tip of big toe L foot and red spot dorsum of second toe on 15Feb2021. The events did not result in emergency room or physician office visit. No treatment was received. Seriousness was reported as no, no result in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. The outcome of events was not recovered.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Seizure
Clinical narrative: convulsing throughout the night; Woke up with a fever of 102.4 degrees; This is a spontaneous report from a contactable consumer(parent).  A 49-year-old patient of an unspecified gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 at single dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medications included 2 types of prescription medication (name of medications not known).  Patient previously received first dose BNT162B2 on unknown date for covid-19 immunization. The patient experienced woke up with a fever of 102.4 degrees and convulsing throughout the night on an unspecified date with outcome of unknown.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pneumonia
Clinical narrative: Pneumonia; she is too weak to move; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. This consumer reported similar events for two patients. This is the first of two reports.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia (pneumonia) on an unspecified date. It was also reported that the patient was unable to receive her second dose since she was too weak to move on an unspecified date. Outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021233483 Same reporter, drug, similar event and different patients
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. The consumer reported similar events for 2 patients. This is 2nd of 2 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pneumonia after receiving first dose. Reporter stated that a friend also got pneumonia after receiving first dose. Outcome of event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021233471 Same reporter, drug, event and different patient
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: terrible sore throat after the first dose; This is a spontaneous report from a Pfizer-sponsored program from a contactable Other HCP report for husband. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The Other HCP asked to cancel the scheduled appointment for her husband's 2nd dose. Her husband had been hospitalized. He has a terrible sore throat after the first dose. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on data provided, the causal association between sore throat and the Pfizer -Biontech Covid 19 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: PPV
Symptoms: Intensive care, Pneumonia
Clinical narrative: Contracted Pneumonia and was in ICU for a week; Contracted Pneumonia and was in ICU for a week; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at single dose for pneumonia. The patient's medical history and concomitant medications were not reported. The patient experienced contracted pneumonia and was in ICU for a week (hospitalization) on an unspecified date with outcome of unknown.    Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rhinorrhoea
Clinical narrative: My nose keeps running; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for herself that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation, tofacitinib citrate (XELJANZ XR 11mg) , via an unspecified route of administration from an unspecified date at 11 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. During an inbound call with the patient, the patient stated that she had the covid shot and she was watching herself while taking her tofacitinib citrate. Her nose kept running. The action taken in response to the event for tofacitinib citrate was unknown. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Renal failure, Renal function test
Clinical narrative: kidney failure; This is a spontaneous report from a Pfizer Sponsored Program from a contactable nurse (patient's daughter). A 101-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 10Feb2021 for COVID-19 immunisation. Medical history and concomitant medication were not reported. Reporter was asking for her mom. Her mom got her first dose of the vaccine on 10Feb. Two weeks after receiving the first dose, her mom's kidney markers elevated leading to kidney failure on an unspecified date. She said that before the vaccine her mom's kidney markers were okay. The outcome of event was unknown.; Sender's Comments: The causal association of the event renal failure and suspected drug BNT162B2 cannot be totally excluded.  Case will be reassessed once new evidences and information are reported.  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: Macular degeneration
Clinical narrative: macular degeneration; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer report for self. This female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Feb2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had a procedure called "macular degeneration" before her 2nd dose vaccine schedule. She had 1st dose last 18Feb2021 and 2nd dose scheduled on 11Mar2021. The outcome of event was unknown.  Information about lot/batch number has been requested.  Amendment: This follow-up report is being submitted to amend previously reported information: to amend "Product Not Administered" to unchecked.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a 70-year-old female patient (reporter's wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergic reaction. The patient was being monitored in the hospital. Corrective treatments taken as a result of the event included antihistamine. The outcome of the event was unknown.  The information on the batch number has been requested.