chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue pruritus, Vaccination site pain
Clinical narrative: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) Immediately got chest pain; Itchy tongue; Severe dizziness and lightheadedness; Turned whiter than white; Lip started to swell and got really itchy; Lip started to swell and got really itchy; Feels tired; Almost died;  This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 53-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 16Aug2021 11:00 as dose 1, single for covid-19 immunisation (age at vaccination: 53 years). Medical history included ongoing rheumatoid arthritis diagnosed with about 6 years ago, overweight from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took bactrim and experienced allergy, cipro [ciprofloxacin] and experienced drug allergy. The patient experienced almost died, feels tired on an unspecified date in Aug2021, immediately got chest pain, itchy tongue, severe dizziness and lightheadedness with, turned whiter than white, lip started to swell and got really itchy on 16Aug2021. The reporter stated that, she received her first dose Pfizer Covid Vaccine on Monday, 16Aug2021. She immediately got chest pain, itchy tongue, severe dizziness and light headedness. The caller s daughter stated, the patient got whiter than white after receiving the first dose Pfizer Covid Vaccine. The caller stated she had the chest pains. Her lip started to swell and got really itchy. She received the first dose Pfizer Covid Vaccine at the Pharmacy and they Pharmacy did not do anything, it was awful. The caller stated she almost died and the pharmacy did nothing. The caller stated she was allergic to Cipro and Bactrim and was overweight. The caller shared this information with the Pharmacy and they said it would be fine. It was reported that, chest pain was still ongoing back and forth. The caller still felt tired and bouts of dizziness. The caller stated the chest pain had improved but still getting bouts and was super tired. Itchy tongue went away maybe about 2.5 hours after, was still having severe dizziness and lightheadedness off and on throughout the day, turned whiter than white, lip swelling and got really itchy went away like a few hours after the first dose. The caller stated, she knew she had to go to the hospital and was covered in hives and had trouble breathing (Caller clarified this occurred after taking Cipro). The caller could not drive and the Pharmacist was a moron and did not do anything, she could have died right there in the pharmacy. The outcome of almost died was unknown, immediately got chest pain was recovering. The outcome of severe dizziness and lightheadedness and feels tired was not recovered, other events: recovered on16Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Heart rate, Pericarditis
Clinical narrative: Pericarditis; Bradycardia; This is a spontaneous report from a contactable consumer. This contactable 33-year-old male consumer (patient) received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0187), via an unspecified route of administration, administered in Arm Left on 13Jul2021 10:30 as dose umber unknown, single for COVID-19 immunisation (Age at Vaccination 33 years). Medical history included cardiac failure, epilepsy, hypothyroidism, coronary artery disease, gastroesophageal reflux disease, drug hypersensitivity (Penicillin). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19 it was unknown. On 16Jul2021 07:00 patient experienced pericarditis, bradycardia, heart rate under 60bpm 47bpm, swelling of heart. The patient underwent lab tests which included heart rate: under 60bpm 47bpm on 16Jul2021. The events did not result into death/ Life threatening/ Caused/prolonged hospitalization/ Disabling/Incapacitating/Congenital anomaly/birth defect. The adverse event result in Emergency room/department or urgent care. No treatment was received as result of events. The outcome of all events was not recovered.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cardiac flutter, Dysgeusia, Feeling abnormal, Headache
Clinical narrative: Heart fluttering; Metallic Taste almost immediately after vaccine; Numb tongue + lips; Headache; Fever; Loss of memory; Brain Fog; This is a spontaneous report from a contactable other Health Care Professional (patient). A 20-years-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number and Expiration date was unspecified), intramuscularly, administered in the left arm on 20Aug2021 at 16:15 (at the age of 20-years-old) as dose 1, single for COVID-19 immunization at public health clinic or veterans administration facility. Medical history included endometriosis from an unknown date, and Patient had known allergies to Carrots, Dust Mites, codeine. Concomitant medication within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC DAIICHI) taken for an unspecified indication, from an unknown start date. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. Since the vaccination, the patient has not been tested for COVID-19. On 20Aug2021 at 17:00, patient developed metallic taste (almost immediately after vaccine) and also experienced heart fluttering, numbness in tongue and lips, headache, fever, loss of memory and brain fog. The events resulted in healthcare professional office or clinic visit. The patient not received any treatment for the events. The outcome of the events was reported as not recovered at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal association the possibility of causal association between the event heart fluttering  and the suspect drug BNT162B2 cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pyrexia
Clinical narrative: Heart fluttering; Metallic Taste almost immediately after vaccine; Numb tongue + lips; Headache; Fever; Loss of memory; Brain Fog; This is a spontaneous report from a contactable other Health Care Professional (patient). A 20-years-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number and Expiration date was unspecified), intramuscularly, administered in the left arm on 20Aug2021 at 16:15 (at the age of 20-years-old) as dose 1, single for COVID-19 immunization at public health clinic or veterans administration facility. Medical history included endometriosis from an unknown date, and Patient had known allergies to Carrots, Dust Mites, codeine. Concomitant medication within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC DAIICHI) taken for an unspecified indication, from an unknown start date. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. Since the vaccination, the patient has not been tested for COVID-19. On 20Aug2021 at 17:00, patient developed metallic taste (almost immediately after vaccine) and also experienced heart fluttering, numbness in tongue and lips, headache, fever, loss of memory and brain fog. The events resulted in healthcare professional office or clinic visit. The patient not received any treatment for the events. The outcome of the events was reported as not recovered at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal association the possibility of causal association between the event heart fluttering  and the suspect drug BNT162B2 cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Myocardial infarction
Clinical narrative: ECG confirmed septal infarct, age undetermined.; This is a spontaneous report from a non-contactable consumer (patient). A 19-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on an unspecified date of 2021 at 13:00 hours as dose 2, single (at the age of 19-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 09Apr2021 at 13:15 as dose 1, single (at the age of 19-years-old) for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 07Jun2021, at 09:00 hours, electrocardiogram (ECG) confirmed septal infarct, age undetermined. Cardiologist running a series of new tests. Patient had doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit for the event. The event was reported as non-serious by the reporter. Patient received no treatment for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Pain, Rosacea
Clinical narrative: bilateral cellulitis elbows; rosacea face; throbbing from elbows to wrists with forced exertion; This is a spontaneous report from a non-contactable consumer. A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EE0151), dose 2 via an unspecified route of administration, administered in arm on an unspecified date (at the age of 61-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included hypertension (HBP), gastrooesophageal reflux disease (GERD), vertigo positional (BPPV) and meniscus injury (torn meniscus R knee) from an unknown date and unknown if ongoing. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: ER8733) as dose 1, single on 21Mar2021 for COVID-19 immunization. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), hydrochlorothiazide, losartan potassium (LOSARTAN HCT), omeprazole (OMEPRAZOLE), diphenhydramine hydrochloride (BENADRYL) and vit d [vitamin d nos] (VIT D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported received other medications in two weeks. The patient previously took z-pak, lorabid and sulfonamide (Known allergies- Sulfa, z-pack, Lorabid) experienced drug hypersensitivity. The patient experienced food allergy (Known allergies: tangerines). The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. The patient experienced bilateral cellulitis elbows, rosacea face, throbbing from elbows to wrists with forced exertion (i.e. coughing, sneezing, bowel movement, etc.). Adverse event resulted in Doctor or other health care professional office/clinic visit. Treatment received for the adverse events include Antibiotic for cellulitis, skin creams for rosacea. No COVID tested post vaccination. The outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Dizziness, Dyspnoea, Heart rate irregular
Clinical narrative: Took blood pressure noticed it was in the low range; irregular heartbeat; Tightness of chest; trouble taking deep breath; felt lightheaded and dizzy; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0186), dose 1 via an unspecified route of administration, administered in Arm Right on 24May2021 (age at the time of vaccination was 39-year-old) as dose 1, single for COVID-19 immunization. No Medical history was reported. Concomitant medication(s) included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported.The patient previously took erythromycin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the tightness of chest and trouble taking deep breaths around 8 PM and next morning felt lightheaded and dizzy on 24May2021. The patient also experienced blood pressure noticed it was in the low range and irregular heartbeat on 25May2021. Those symptoms continued for roughly a month. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken for events (Testing and referral for further testing). It was reported that patient saw PCP and after testing was done suggested the patient to visit a neurologist, appointment with neurologist was in Sep2021. Device Date was reported as 21Aug2021. Outcome of all the events was reported as Unknown at this time of the report.   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Investigation
Clinical narrative: Took blood pressure noticed it was in the low range; irregular heartbeat; Tightness of chest; trouble taking deep breath; felt lightheaded and dizzy; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0186), dose 1 via an unspecified route of administration, administered in Arm Right on 24May2021 (age at the time of vaccination was 39-year-old) as dose 1, single for COVID-19 immunization. No Medical history was reported. Concomitant medication(s) included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported.The patient previously took erythromycin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the tightness of chest and trouble taking deep breaths around 8 PM and next morning felt lightheaded and dizzy on 24May2021. The patient also experienced blood pressure noticed it was in the low range and irregular heartbeat on 25May2021. Those symptoms continued for roughly a month. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken for events (Testing and referral for further testing). It was reported that patient saw PCP and after testing was done suggested the patient to visit a neurologist, appointment with neurologist was in Sep2021. Device Date was reported as 21Aug2021. Outcome of all the events was reported as Unknown at this time of the report.   Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Inappropriate schedule of product administration
Clinical narrative: administration date: 31Jul2021; This is a spontaneous report from a contactable Nurse (patient reporting herself). This 56-year-old female Nurse (Patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FA7485) via an unspecified route of administration on 31Jul2021 at 11:30 on left arm (at 56-year-old), as dose 2, single for COVID-19 immunization. The medical history of the patient included spondylolisthesis s/p fusion and scarlet fever age 18. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8729) via an unspecified route of administration on 06Apr2021 at 04:00 PM (at 56-year-old) on left arm as dose 1, single for COVID-19 immunization and experienced heart rate dropped to as low as 30. It was mentioned that no other vaccines were received in four weeks. The other medications in two weeks were reported as none. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. The allergies were reported as none. On an unknown date the patient reported inappropriate schedule of vaccine administered. The event resulted in disability or permanent damage. No treatment was received, and patient had not recovered.; Sender's Comments: Based on the information in the case, a causal relationship between inappropriate schedule of vaccination and suspect drug BNT162B2 cannot be excluded
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure that may have been a PNES seizure.; This is a spontaneous report from a contactable Consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FC3182), via unspecified route of administration, administered in left arm, on 17Aug2021 at 12:00 PM (15-year-old at the time of vaccination), as dose 1, single for COVID-19 immunization. Medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies. On 17Aug2021 at 12:00 PM, the patient experienced Seizure that may have been a PNES (psychogenic non-epileptic seizure) seizure. As a result, the patient visited emergency room. The patient did not receive any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination and not tested for covid post vaccination. On an unknown date in 2021, the outcome of the event was recovered.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dyskinesia, Eye pain, Facial paralysis, Fatigue
Clinical narrative: had a stroke; Right facial paralysis; mouth swelling; mouth numbness and swelling; mouth numbness and swelling, scramble, imbalance; fatigue; left eye pain due unable to close; arm pain; This is a spontaneous report from a contactable consumer.  A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, in Arm Left on 13Mar2021 12:45 (Batch/Lot number was not reported) (at the age of 51-years-old) as single dose for covid-19 immunisation.  Medical history included known allergies not to food, to some medications. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant drugs included prescribed medication since a long time. On 13Mar2021 the patient experienced right facial paralysis, mouth swelling, mouth numbness and swelling, scramble, imbalance, arm pain, fatigue, after been at the hospital it moved to the left side of face, left eye pain due unable to close. She had a stroke. The patient was hospitalized for 2 days and treatment for the events was received. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability. The outcome of the events was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Mouth swelling, Pain in extremity
Clinical narrative: had a stroke; Right facial paralysis; mouth swelling; mouth numbness and swelling; mouth numbness and swelling, scramble, imbalance; fatigue; left eye pain due unable to close; arm pain; This is a spontaneous report from a contactable consumer.  A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, in Arm Left on 13Mar2021 12:45 (Batch/Lot number was not reported) (at the age of 51-years-old) as single dose for covid-19 immunisation.  Medical history included known allergies not to food, to some medications. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant drugs included prescribed medication since a long time. On 13Mar2021 the patient experienced right facial paralysis, mouth swelling, mouth numbness and swelling, scramble, imbalance, arm pain, fatigue, after been at the hospital it moved to the left side of face, left eye pain due unable to close. She had a stroke. The patient was hospitalized for 2 days and treatment for the events was received. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability. The outcome of the events was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Chest pain, Dysmenorrhoea, Fatigue, Feeling abnormal
Clinical narrative: huge blood clots; Period is two weeks early; Period is two weeks early with major cramping; brain fog; extreme bloating; extreme fatigue; headache; arm pain at injection site; weight gain; chest pain; thick sputum; This is a spontaneous report from a contactable Other HCP (patient).   A 37-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 04Aug2021 13:00 (at the age of 37-year-old) (Batch/Lot Number: Fc3180) as single dose for COVID-19 immunisation, administered at Pharmacy or Drug Store.  The patient medical history was not reported. Known allergies: Iodine, codeine. The concomitant medications in 2 weeks were none. The patient previously received bnt162b2 dose 1 at right arm on 28Jan2021 16:00 (Lot number: El9265) as single dose for COVID-19 immunisation. No other vaccine in four weeks. Patient was not pregnant. No COVID prior vaccination. On 08Aug2021 14:30 the patient experienced huge blood clots (medically significant) with outcome of not recovered, period is two weeks early (non-serious) with outcome of not recovered, period is two weeks early with major cramping (non-serious) with outcome of not recovered, brain fog (non-serious) with outcome of not recovered, extreme bloating (non-serious) with outcome of not recovered, extreme fatigue (non-serious) with outcome of not recovered, headache (non-serious) with outcome of not recovered , arm pain at injection site (non-serious) with outcome of not recovered, weight gain (non-serious) with outcome of not recovered, chest pain (non-serious) with outcome of not recovered, thick sputum (non-serious) with outcome of not recovered. The course of events was as follows: Period was two weeks early with major cramping and huge blood clots, brain fog, extreme bloating, extreme fatigue, headache, arm pain at injection site, weight gain and chest pain with thick sputum. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Sars-cov-2 rapid test (nasal swab): negative on 18Aug2021. Therapeutic measures were taken as a result of the events: antibiotics.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Polymenorrhoea, Productive cough, SARS-CoV-2 test negative, Thrombosis
Clinical narrative: huge blood clots; Period is two weeks early; Period is two weeks early with major cramping; brain fog; extreme bloating; extreme fatigue; headache; arm pain at injection site; weight gain; chest pain; thick sputum; This is a spontaneous report from a contactable Other HCP (patient).   A 37-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 04Aug2021 13:00 (at the age of 37-year-old) (Batch/Lot Number: Fc3180) as single dose for COVID-19 immunisation, administered at Pharmacy or Drug Store.  The patient medical history was not reported. Known allergies: Iodine, codeine. The concomitant medications in 2 weeks were none. The patient previously received bnt162b2 dose 1 at right arm on 28Jan2021 16:00 (Lot number: El9265) as single dose for COVID-19 immunisation. No other vaccine in four weeks. Patient was not pregnant. No COVID prior vaccination. On 08Aug2021 14:30 the patient experienced huge blood clots (medically significant) with outcome of not recovered, period is two weeks early (non-serious) with outcome of not recovered, period is two weeks early with major cramping (non-serious) with outcome of not recovered, brain fog (non-serious) with outcome of not recovered, extreme bloating (non-serious) with outcome of not recovered, extreme fatigue (non-serious) with outcome of not recovered, headache (non-serious) with outcome of not recovered , arm pain at injection site (non-serious) with outcome of not recovered, weight gain (non-serious) with outcome of not recovered, chest pain (non-serious) with outcome of not recovered, thick sputum (non-serious) with outcome of not recovered. The course of events was as follows: Period was two weeks early with major cramping and huge blood clots, brain fog, extreme bloating, extreme fatigue, headache, arm pain at injection site, weight gain and chest pain with thick sputum. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Sars-cov-2 rapid test (nasal swab): negative on 18Aug2021. Therapeutic measures were taken as a result of the events: antibiotics.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Weight increased
Clinical narrative: huge blood clots; Period is two weeks early; Period is two weeks early with major cramping; brain fog; extreme bloating; extreme fatigue; headache; arm pain at injection site; weight gain; chest pain; thick sputum; This is a spontaneous report from a contactable Other HCP (patient).   A 37-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 04Aug2021 13:00 (at the age of 37-year-old) (Batch/Lot Number: Fc3180) as single dose for COVID-19 immunisation, administered at Pharmacy or Drug Store.  The patient medical history was not reported. Known allergies: Iodine, codeine. The concomitant medications in 2 weeks were none. The patient previously received bnt162b2 dose 1 at right arm on 28Jan2021 16:00 (Lot number: El9265) as single dose for COVID-19 immunisation. No other vaccine in four weeks. Patient was not pregnant. No COVID prior vaccination. On 08Aug2021 14:30 the patient experienced huge blood clots (medically significant) with outcome of not recovered, period is two weeks early (non-serious) with outcome of not recovered, period is two weeks early with major cramping (non-serious) with outcome of not recovered, brain fog (non-serious) with outcome of not recovered, extreme bloating (non-serious) with outcome of not recovered, extreme fatigue (non-serious) with outcome of not recovered, headache (non-serious) with outcome of not recovered , arm pain at injection site (non-serious) with outcome of not recovered, weight gain (non-serious) with outcome of not recovered, chest pain (non-serious) with outcome of not recovered, thick sputum (non-serious) with outcome of not recovered. The course of events was as follows: Period was two weeks early with major cramping and huge blood clots, brain fog, extreme bloating, extreme fatigue, headache, arm pain at injection site, weight gain and chest pain with thick sputum. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Sars-cov-2 rapid test (nasal swab): negative on 18Aug2021. Therapeutic measures were taken as a result of the events: antibiotics.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: heart felt like someone was squeezing it. The pain was so intense that it woke me up in the morning while I was sleeping.; This is a spontaneous report from a non-contactable consumer.  A 36-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jun2021 (Batch/Lot number was not reported) (at the age of 36-years-old ) as single dose for covid-19 immunisation.  Medical history was none. Concomitant medications included levonorgestrel (MIRENA) taken for an unspecified indication. The patient was not pregnant.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no Known allergies. The day after the first injection on 08Jun2021 the patient's heart felt like someone was squeezing it. The pain was so intense that it woke her up in the morning while she was sleeping. About a week later this happened again when she was walking down the stairs. Again, the pain was so intense it stopped her in her tracks. This pain has not occurred again. The event required Physician Office Visit. No treatment was received. For the records, she was active, fit, and healthy. She run and lift weights several times a week, maintain a healthy diet, have a healthy body weight, and was a former college athlete. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Then the patient received the second dose of vaccine on 28Jun2021 (Batch/Lot number was not reported).   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Fatigue, Headache, Hypersensitivity, Nausea
Clinical narrative: Severe allergic reaction; headache; tired within 5 minuets; about 30 minuets in it turned to nausea; then throat started to feel tight; wheezing in lungs; Lips tingling; Face tingling; Eyes went itchy; This is a spontaneous report from a contactable consumer.  A 28-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 20Aug2021 15:30 (Batch/Lot number was not reported) (at the age of 28-years-old female ) as single dose for covid-19 immunisation  .  Medical history included covid-19 from an unknown date and obesity. The patient was not pregnant. Concomitant medications included buspirone 40mgs taken for an unspecified indication; escitalopram 25mgs taken for an unspecified indication; hydroxyzine 10 taken for an unspecified indication.  The patient had known allergies to  allergies to Lamictal, abilify and strattera.  On 20Aug2021 at 15:45 the patient had severe allergic reaction. Headache and tired within 5 minuets then about 30 minuets in it turned to nausea then throat started to feel tight with wheezing in lungs, lips and face went tingling and eyes went itchy. The events resulted in Emergency room/department or urgent care. The patient was treated with Iv benadryl, stairoid, histamine uptake, ep shot. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Throat tightness, Wheezing
Clinical narrative: Severe allergic reaction; headache; tired within 5 minuets; about 30 minuets in it turned to nausea; then throat started to feel tight; wheezing in lungs; Lips tingling; Face tingling; Eyes went itchy; This is a spontaneous report from a contactable consumer.  A 28-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 20Aug2021 15:30 (Batch/Lot number was not reported) (at the age of 28-years-old female ) as single dose for covid-19 immunisation  .  Medical history included covid-19 from an unknown date and obesity. The patient was not pregnant. Concomitant medications included buspirone 40mgs taken for an unspecified indication; escitalopram 25mgs taken for an unspecified indication; hydroxyzine 10 taken for an unspecified indication.  The patient had known allergies to  allergies to Lamictal, abilify and strattera.  On 20Aug2021 at 15:45 the patient had severe allergic reaction. Headache and tired within 5 minuets then about 30 minuets in it turned to nausea then throat started to feel tight with wheezing in lungs, lips and face went tingling and eyes went itchy. The events resulted in Emergency room/department or urgent care. The patient was treated with Iv benadryl, stairoid, histamine uptake, ep shot. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Behaviour disorder, Blood test, Condition aggravated, Emotional distress, Mental disorder
Clinical narrative: Major breakdown; was diagnosed with a 'behavior'  disorder; suffering and I am very upset; got worse; This is a spontaneous report from a contactable consumer (patient reported for herself). A 44-year-old female patient received bnt162b2 (PFIZER COVID VACCINE, Solution for injection, lot number: EW0181), via an unspecified route of administration on 03Jul2021 (age at the vaccination 44-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date 2021, the patient had a major breakdown, and the patient was diagnosed with a 'behavior' disorder (Not appropriately clarified hence disorder captured as event) due to Pfizer vaccine. The patient stated that it got worse and, the patient was rush to the hospital and blood work done all kind of stuff. The patient asked another question patient want to file a lawsuit as, the patient stated that "suffering and I am very upset". The patient lab test which included blood work was unknown on an unknown date 2021. The patient had taken a lots of treatment fostair 6 steroid was what the patient had but it was not working. That was steroid (unspecified). The medicine that patient had was steroid and the cream (unspecified), but it did not work for any way for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Both of them are positive (confirmed as COVID positive); Both of them are positive (confirmed as COVID positive); This is a spontaneous report from a Pfizer Sponsored Program of Pfizer via a contactable consumer (patient).  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date, after receiving first dose of vaccination, patient was tested positive for COVID-19. On an unspecified date patient underwent lab test of COVID and tested positive. Patient was due for second dose on the date of report and asked if she could take the dose. Outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I could have blood clots; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: FA7484) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that: "I could have blood clots" on an unspecified date with outcome of unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: The next day on 07Apr21 my daughter started having syncope episodes. They have gotten increasingly worse since then; This is a spontaneous report from a contactable consumer (parent). A 16-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as dose 1, single; then dose 2 via an unspecified route of administration, administered in Arm Left on unspecified date (Batch/Lot number was not reported) as dose 2, single (at the age of 16 years) for covid-19 immunisation. The patient's medical history included covid-19 (prior to vaccination)from an unknown date and unknown if ongoing. Concomitant medications included lurasidone hydrochloride (LATUDA); omeprazole (OMEPRAZOLE); propranolol (PROPANOLOL [PROPRANOLOL]); riboflavin (RIBOFLAVIN); magnesium oxide (MAGNESIUM OXIDE); trazodone (TRAZODONE); ethinylestradiol, norethisterone acetate (LOESTRIN), all were taken for an unspecified indication, start and stop date were not reported. The patient previously took keppra [levetiracetam] and amoxicillin and had allergies (known allergies to Keppra and amoxicillin). The patient experienced the next day (reported as 07Apr21) patient started having syncope episodes, they have gotten increasingly worse since then on unspecified date in 2021. It was reported that the patient was hospitalized for 3 days due to the event. It was also reported that the event resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the event was not recovered. The patient was not tested for Covid-19 post vaccination.    The lot number for vaccine [BNT162B2], was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Illness, Influenza like illness, Nasal congestion
Clinical narrative: not being able to breathe; Runny nose; congestion; fever; headache; feeling of being sick; flu like symptoms; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp.   A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown and expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included vitiligo. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced runny nose, congestion, fever, headache, not being able to breathe, feeling of being sick and flu like symptoms on an unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on an unknown date. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of runny nose, congestion, fever, headache, not being able to breathe, feeling of being sick and flu like symptoms (Pain killers, flu medicine). Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: not being able to breathe; Runny nose; congestion; fever; headache; feeling of being sick; flu like symptoms; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp.   A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown and expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included vitiligo. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced runny nose, congestion, fever, headache, not being able to breathe, feeling of being sick and flu like symptoms on an unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on an unknown date. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of runny nose, congestion, fever, headache, not being able to breathe, feeling of being sick and flu like symptoms (Pain killers, flu medicine). Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic product effect decreased
Clinical narrative: what is in this COVID vaccine that's making the Xeljanz not work for me anymore; This is a spontaneous report from contactable consumer. This 72-year-old female contactable consumer (patient) reported for self that received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date (at 72-year-old), as dose number unknown, single for COVID-19 immunization and tofacitinib citrate (xeljanz) at an unknown dose for unknown indication. The patient's medical history and concomitant medications were not reported. On an unknown date the patient complained that COVID vaccine made the Xeljanz not work for patient anymore It was mentioned that patient was on Xeljanz, she called in saying that she recently got her COVID shot and now the Xeljanz was not working. Consumer stated that she had been taking Xeljanz for few years and everything was going fine, she had no problem after she took the COVID shot, the Xeljanz has stopped working, She had been in so much pain to the point where you can barely walk sometimes, she had arthritis (Intent: Indication). She wondered if what was in this COVID vaccine that's making the Xeljanz not work for her anymore, since they were made by the same company. Consumer was provided with the number of Pfizer Medical Information Department. The event outcome was unknown.  PSCC Communication: PC Filed.   QR comment: CEP ID was not available over the call, hence CEP name was captured as Xelsource. Is there a Product Complaint: Yes Description of Product Complaint: Call was transferred from Xelsource by withheld. Transferring agent stated, "I do have a patient on the backline who have couple of question regarding the Pfizer. She is on Xeljanz, she called in saying that she recently got her COVID shot and now the Xeljanz is not working, she just had a couple of questions, I do have her on the back line." Consumer stated, "I have been taking Xeljanz for few years and everything was going fine, no problem after I took the COVID shot, the Xeljanz has stopped working, I have been in so much pain to the point where you can barely walk sometimes, I have arthritis (Intent: Indication). I was wondering what is in this COVID vaccine that's making the Xeljanz not work for me anymore, since they are made by the same company." Limited information was available over the call.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.