chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Allergy to animal, Ear discomfort, Lymphadenopathy, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: rashes; throat and glands have been extremely swollen; throat and glands have been extremely swollen; had allergic reactions to things that I have never had reactions to in my life, such as dogs and horses; sore throat; plugged ears; had a fever multiple times a day; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient (non-pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via an unspecified route of administration on an unspecified date as single dose; the second dose via an unspecified route of administration in the arm left on unspecified date as single dose for COVID-19 immunization. Medical history included allergy to Sulfa. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient reported that since vaccines, especially the second, patient throat and glands had been extremely swollen. Patient had had allergic reactions to things that she had never had reactions to in her life, such as dogs and horses. Patient had an insanely sore throat and plugged ears, which she had two rounds of antibiotics for and has done nothing. Adverse events start date/time was 25Apr2021 12:00. Patient also had rashes and every day since the first shot on unspecified date, she had a fever multiple times a day on 25Apr2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Lab data included Binax was negative (Nasal Swab) on 11May2021 and PCR was negative on 11May2021. Treatment received for events. The outcome of the event rashes was unknown, while of the other events was not recovered. This report was assessed by the reporting consumer as non-serious; no results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: rashes; throat and glands have been extremely swollen; throat and glands have been extremely swollen; had allergic reactions to things that I have never had reactions to in my life, such as dogs and horses; sore throat; plugged ears; had a fever multiple times a day; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient (non-pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via an unspecified route of administration on an unspecified date as single dose; the second dose via an unspecified route of administration in the arm left on unspecified date as single dose for COVID-19 immunization. Medical history included allergy to Sulfa. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient reported that since vaccines, especially the second, patient throat and glands had been extremely swollen. Patient had had allergic reactions to things that she had never had reactions to in her life, such as dogs and horses. Patient had an insanely sore throat and plugged ears, which she had two rounds of antibiotics for and has done nothing. Adverse events start date/time was 25Apr2021 12:00. Patient also had rashes and every day since the first shot on unspecified date, she had a fever multiple times a day on 25Apr2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Lab data included Binax was negative (Nasal Swab) on 11May2021 and PCR was negative on 11May2021. Treatment received for events. The outcome of the event rashes was unknown, while of the other events was not recovered. This report was assessed by the reporting consumer as non-serious; no results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Looks like small hives; Rash all over my sides, stomach, too potion of thighs. Started about a week and a half after my last dose. Started out on my right rib cage and then moved through rest over the next week.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in left arm in Apr2021 (Lot Number: Ep7533) at the age of 40 years as single dose for Covid-19 immunization. Medical history included hyperthyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included the first dose of BNT162B2 (lot number: Er8735) administered in left arm on 31Mar2021 at the age of 40 years as single dose for Covid-19 immunization. Patient was not pregnant. There was no other vaccine in four weeks, no Covid prior vaccination, no known allergies. Patient experienced rash all over her sides, stomach, too potion of thighs. Started on 01May2021 04:00 PM, about a week and a half after her last dose. Started out on her right rib cage and then moved through rest over the next week. Went to care spot where they couldn't make any connection to things and gave her an oral steroid to take daily for a week, which didn't help. Ae resulted in doctor or other healthcare professional office/clinic visit. No Covid was tested post vaccination. Outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: dizziness; losing consciousness; falling; This is a spontaneous report from a contactable consumer reported for himself. This 62-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05May2021 for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient stated he received his first dose of the Pfizer covid vaccine on 05May and on 06May2021 he started losing consciousness and falling. On 09May he called 911 and was taken to the emergency department (ED) where he was told he was having side effects to the vaccine. He had been feeling this way ever since and his dizziness was continuing. He had concerned about receiving his second covid vaccination and wanted to know what he should do. Outcome of the events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Laboratory test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable consumer (patient). This 51 years old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) the first single dose on 31Mar2021 (lot EN6199) in left arm and the second single dose on 21Apr2021 (lot ER8737), both at 51 years of age, for COVID-19 immunisation. Relevant medical history, family history and concomitant medications were none. She had no problems with unspecified shots in the past. The patient had her second dose of the Pfizer COVID 19 vaccine and tested positive on 14May2021 (she got the results on 15May2021). Testing was swabbed from mouth. Her 16 years old teenage daughter turned out to be positive for COVID so she got tested. She didn't have any symptoms at that time, but right now she had like a cold. The patient added that she lost her smell. The event required physician office visit. She was not hospitalized. The event did not require any treatment or ER visit or hospitalization. She did not display clinical signs at rest indicative of severe systemic illness. The event did not result in multiorgan failure, respiratory diseases, cardiovascular diseases, gastrointestinal/hepatic diseases, renal diseases, neurological diseases, hematological diseases or dermatological diseases. COVID-19 was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Syncope
Clinical narrative: She fainted when she had it and she has a headache; She fainted when she had it and she has a headache; This is a spontaneous report from a contactable consumer reported for daughter. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16May2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. She fainted when she had it on 17May2021 and she had a headache in May2021. Outcome of the events was unknown.  Information about Lot/ batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: multiple sclerosis; This is a spontaneous report from a contactable consumer (patient). This 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 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced multiple sclerosis. Patient wanted to get know if she can get revaccinated because of her current multiple sclerosis condition. She was quite concerned because she got her second shot of the vaccine 3 weeks after receiving the infusion for her multiple sclerosis condition. Patient stated she got the 2nd shot of the vaccine 3 weeks after the infusion for her multiple sclerosis medical condition. She wanted to get a yes or no answer if she can get revaccinated given that she got the 2nd shot of the Pfizer BioNTech Covid-19 Vaccine 3 weeks after the infusion for her multiple sclerosis medical condition. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Hallucination, auditory
Clinical narrative: Caller states she got her first Pfizer Covid vaccine on 20Apr2021 and has since had trouble focusing and reports she is "hearing things that aren't there."; trouble focusing; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that that the female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced caller states she got her first pfizer covid vaccine on 20apr2021 and has since had trouble focusing and reports she is "hearing things that aren't there." on an unspecified date with outcome of unknown, trouble focusing on an unspecified date with outcome of unknown.    The clinical course was reported as follows: Caller states she got her first Pfizer Covid vaccine on 20Apr2021 and has since had trouble focusing and reports she is "hearing things that aren't there." She wants to know with these side effects, should she proceed with the second dose. Agent states the caller on the line received her first vaccine and after that she had some strange side effects, she had trouble focusing and hearing things that were not there, agent states the caller has her second vaccine scheduled for tomorrow and wants to know if she should get it. Caller confirmed details provided. Confirms she received the first dose of the Pfizer Covid vaccine on 20 APR 2021, caller declines to provide further information for a report at this time, states she has to get back to work.   Follow-up needed. Information about batch/lot number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chest X-ray, Influenza virus test, Investigation
Clinical narrative: weak; Low kidney function; Low platelets/platelets numbers are low; kidney numbers are low; Fever up to 102.5F; This is a spontaneous report from a contactable consumer. A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 08:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included covid-19 from Nov2020 to an unknown date.   Patient previously received the first dose of BNT162B2 for  covid-19 immunization. There were no concomitant medications. Consumer is the sister of the patient that after getting the second dose of the Pfizer covid vaccine is experiencing after several days fever up to 102.5F on 04May2021, low platelets and low kidney function. her brother who is too weak right now to call.  He got his second vaccine and right now it will be 2 weeks ago, he got it on 03May2021, he had the COVID virus in Nov, it has been 2 weeks since the second dose as of tomorrow and he has had 102 degree fever the whole time throughout the day and night. She is trying to understand if this is something to be concerned about. He had blood work done and his platelets numbers are low and his kidney numbers are low and she is looking for peace of mind of if this is commonly reported adverse event or maybe the steps to be taken. She says she works for (Company) so she familiar with having to report adverse events. Her brother is also awaiting chest x-ray results, he was negative for mono, flu, and negative for COVID.The patient underwent lab tests and procedures which included body temperature: 102.5 fahrenheit on 04May2021, chest x-ray: unknown results, influenza virus test: negative, investigation: low   on 13May2021, mononucleosis heterophile test: negative, platelet count: low   on 13May2021, sars-cov-2 test: negative. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Mononucleosis heterophile test, Platelet count, Platelet count decreased, Pyrexia, Renal disorder
Clinical narrative: weak; Low kidney function; Low platelets/platelets numbers are low; kidney numbers are low; Fever up to 102.5F; This is a spontaneous report from a contactable consumer. A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 08:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included covid-19 from Nov2020 to an unknown date.   Patient previously received the first dose of BNT162B2 for  covid-19 immunization. There were no concomitant medications. Consumer is the sister of the patient that after getting the second dose of the Pfizer covid vaccine is experiencing after several days fever up to 102.5F on 04May2021, low platelets and low kidney function. her brother who is too weak right now to call.  He got his second vaccine and right now it will be 2 weeks ago, he got it on 03May2021, he had the COVID virus in Nov, it has been 2 weeks since the second dose as of tomorrow and he has had 102 degree fever the whole time throughout the day and night. She is trying to understand if this is something to be concerned about. He had blood work done and his platelets numbers are low and his kidney numbers are low and she is looking for peace of mind of if this is commonly reported adverse event or maybe the steps to be taken. She says she works for (Company) so she familiar with having to report adverse events. Her brother is also awaiting chest x-ray results, he was negative for mono, flu, and negative for COVID.The patient underwent lab tests and procedures which included body temperature: 102.5 fahrenheit on 04May2021, chest x-ray: unknown results, influenza virus test: negative, investigation: low   on 13May2021, mononucleosis heterophile test: negative, platelet count: low   on 13May2021, sars-cov-2 test: negative. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Renal impairment, SARS-CoV-2 test
Clinical narrative: weak; Low kidney function; Low platelets/platelets numbers are low; kidney numbers are low; Fever up to 102.5F; This is a spontaneous report from a contactable consumer. A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 08:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included covid-19 from Nov2020 to an unknown date.   Patient previously received the first dose of BNT162B2 for  covid-19 immunization. There were no concomitant medications. Consumer is the sister of the patient that after getting the second dose of the Pfizer covid vaccine is experiencing after several days fever up to 102.5F on 04May2021, low platelets and low kidney function. her brother who is too weak right now to call.  He got his second vaccine and right now it will be 2 weeks ago, he got it on 03May2021, he had the COVID virus in Nov, it has been 2 weeks since the second dose as of tomorrow and he has had 102 degree fever the whole time throughout the day and night. She is trying to understand if this is something to be concerned about. He had blood work done and his platelets numbers are low and his kidney numbers are low and she is looking for peace of mind of if this is commonly reported adverse event or maybe the steps to be taken. She says she works for (Company) so she familiar with having to report adverse events. Her brother is also awaiting chest x-ray results, he was negative for mono, flu, and negative for COVID.The patient underwent lab tests and procedures which included body temperature: 102.5 fahrenheit on 04May2021, chest x-ray: unknown results, influenza virus test: negative, investigation: low   on 13May2021, mononucleosis heterophile test: negative, platelet count: low   on 13May2021, sars-cov-2 test: negative. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Neuropathy peripheral
Clinical narrative: increasing in episodes of A-Fib strong enough where she was aware of them; peripheral neuropathy was greatly worsened; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 14:30 (Lot Number: EW0172) as 1st dose, single dose for covid-19 immunisation. No pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included ongoing Peripheral neuropathy from chemo, asthma, ongoing A-Fib, Known allergies: Yes. Concomitant medications included unspecified drugs that the patient received within 2 weeks of vaccination. On 23Apr2021, the patient experienced increasing in episodes of A-Fib strong enough where she was aware of them. She slips into and out of it many times daily but am usually not aware when it occurs. Since the vaccine these episodes are such that she was well aware of them. Her electrophysiologist had others reporting same. Also, peripheral neuropathy was greatly worsened. No treatment received. The events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The second dose of BNT162B2 was on 14May2021 03:00 PM (lot number: EW0167, Vaccine location: Right arm) for covid-19 immunisation. Outcome of the events was not recovered. The case was reported as non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear pain, Tinnitus
Clinical narrative: slight hearing loss; I've experienced ear pain; ringing in my ears; This is a spontaneous report from a contactable consumer who reported for herself that a 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-years, via an unspecified route of administration, administered in left arm on 14May2021 16:45 at single dose for COVID-19 immunisation, in pharmacy/drug store. Medical history included prior to vaccination, was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were reported as none. No other medications the patient received within 2 weeks of vaccination. On an unspecified date (reported as on 08May2021), the patient experienced ear pain and ringing in her ears and slight hearing loss. Outcome of the events was not recovered/not resolved. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Magnetic resonance imaging, Mobility decreased, Scan brain, Seizure
Clinical narrative: Unable to use left arm or hand; Seizure; Lost vision in left eye; This is a spontaneous report from a contactable consumer (patient wife). A 74-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 31Mar2021 10:00 (Batch/Lot Number: ER8730) (at 74 year old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included slight stroke from 2012, seizure disorder from 1972 and ongoing (She says her husband did have a seizure disorder since his car accident in 1972, but he hadn't had a seizure in years), road traffic accident from 1972 (Caller says her husband had a car accident in 1972 and had some injuries from that), injury from 1972 (Caller says her husband had a car accident in 1972 and had some injuries from that). The patient's concomitant medications were not reported. Historical Vaccine included first dose (LOT: EN6199) of BNT162B2 (Pfizer COVID-19 vaccine) for COVID-19 immunization on 10Mar2021 10:00AM in his right arm at 74-year-old experienced tiredness and arm soreness. The patient experienced seizure on 20Apr2021 with outcome of recovered in 2021, lost vision in left eye on 20Apr2021 with outcome of recovered on 21Apr2021, unable to use left arm or hand on 20Apr2021 with outcome of recovered on 21Apr2021. The events caused Emergency Room Visit, and were serious due to hospitalization since 20Apr2021 to May2021 for 19 days. The patient underwent lab tests and procedures which included magnetic resonance imaging and scan brain: no evidence of a stroke said it was a seizure on 20Apr2021. The consumer reported that her husband ended up going to the ER and spending 2.5 weeks in hospital after the second dose. She says it started out like a stroke, he lost vision in his left eye temporarily then couldn't use his left arm, couldn't raise it or use his hand or wiggle his fingers. She says that ended up being temporary too. She says he then took a seizure before the ambulance got there, so when he got to the hospital they assumed it was stroke and a seizure and he ended up in intensive care unit. She says as days went on and they did MRIs and brain scans, stuff like that, they found no evidence of a stroke said it was a seizure that caused it, and that next day he got his vison back after he was there overnight in the intensive care unit, and could use his arm, raise his arm, and hold things with his left hand. She says it was 20Apr, 20 days later, that this occurred and he was admitted to the hospital. The patient was home now after spending 2.5 weeks in the hospital. She says he is home and doing ok, he is back to how he was. She says that they did give him a seizure medicine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: underlying Atrial Fibrillation; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ER2613 or EL2613), via an unspecified route of administration, administered in upper arm on 15Apr2021 at the age of 72 years as single dose for covid-19 immunisation. Medical history included atrial fibrillation from 2017, diagnosed around 4 years ago, stroke from 11Sep2001, osteoarthritis from 2019 diagnosed around 2 years ago. Concomitant medications included verapamil hydrochloride (VERAPAMIL ER) at 120mg for atrial fibrillation, apixaban (ELIQUIS) at 5 mg twice a day to prevent a stroke. Historical vaccine included the first dose of BNT162B2 (lot ENB208 or EN6208) received on 22Mar2021 at the age of 72 years for Covid-19 immunization. She had underlying Atrial Fibrillation and had 2 episodes where she sent to the ER after getting vaccinated with the 2nd dose. The first time the patient went into atrial fibrillation was on 24Apr2021 and she had to visit the Emergency room. Patient was given multiple IVs and had to stay in the emergency room for 24 hours. Patient was sent home on 25Apr2021 but she had an old stroke so she was unsure if they formally admitted her to the hospital or not. The second time patient went into atrial fibrillation she had to visit the Emergency room. It was on 15May2021 and the patient had to stay there for a little bit but then came out of atrial fibrillation and was sent home that same day, 15May2021. Patient had been out of atrial fibrillation since the 15May2021. Outcome of event was recovered on 15May2021.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Migraine, Neurological symptom, Renal function test
Clinical narrative: neurological symptoms; developed a migraine headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 01Apr2021 14:15 (lot number: ER8737) at the age of 59 years old, as 1ST DOSE SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed a migraine headache on 06Apr2021 and neurological symptoms on an unspecified date. The doctor and neurologist were testing her. Clearly migraines medication can't help it. Her physician is working with her other doctor to try to figure it out. He worked with other patients with long term side effects from the vaccine. She is wondering if there is any literature on migraines as a long-term side effect. She got the first vaccine on 01Apr2021. She started having migraines on 06Apr2021. She has tried taking multiple medications. She has been to the emergency room for and infusion, and she had an infusion at her neurologist office. She received Saline with magnesium and Toradol. She received Reglan, DHE, and Decadron. She also tried (withheld) CGRP 50mg and 100mg. She received the second dose 21Apr2021. The second lot was ER8735. She got the first vaccine in her left arm, and the second one in her right. She received the doses at 2:15pm. Migraine headache also required visit to Physician office. No prior vaccination within 4 weeks. No other AEs prior to vaccinations. All the blood work at hospital came out normal and kidney function was one marker a little out of normal range. The patient has not recovered from the events.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bradykinesia, Disturbance in attention, Electrocardiogram normal, Fatigue, Full blood count normal
Clinical narrative: neurological symptoms; developed a migraine headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 01Apr2021 14:15 (lot number: ER8737) at the age of 59 years old, as 1ST DOSE SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed a migraine headache on 06Apr2021 and neurological symptoms on an unspecified date. The doctor and neurologist were testing her. Clearly migraines medication can't help it. Her physician is working with her other doctor to try to figure it out. He worked with other patients with long term side effects from the vaccine. She is wondering if there is any literature on migraines as a long-term side effect. She got the first vaccine on 01Apr2021. She started having migraines on 06Apr2021. She has tried taking multiple medications. She has been to the emergency room for and infusion, and she had an infusion at her neurologist office. She received Saline with magnesium and Toradol. She received Reglan, DHE, and Decadron. She also tried (withheld) CGRP 50mg and 100mg. She received the second dose 21Apr2021. The second lot was ER8735. She got the first vaccine in her left arm, and the second one in her right. She received the doses at 2:15pm. Migraine headache also required visit to Physician office. No prior vaccination within 4 weeks. No other AEs prior to vaccinations. All the blood work at hospital came out normal and kidney function was one marker a little out of normal range. The patient has not recovered from the events.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hyperacusis, Magnetic resonance imaging normal, Metabolic function test, Methylmalonic aciduria
Clinical narrative: neurological symptoms; developed a migraine headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 01Apr2021 14:15 (lot number: ER8737) at the age of 59 years old, as 1ST DOSE SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed a migraine headache on 06Apr2021 and neurological symptoms on an unspecified date. The doctor and neurologist were testing her. Clearly migraines medication can't help it. Her physician is working with her other doctor to try to figure it out. He worked with other patients with long term side effects from the vaccine. She is wondering if there is any literature on migraines as a long-term side effect. She got the first vaccine on 01Apr2021. She started having migraines on 06Apr2021. She has tried taking multiple medications. She has been to the emergency room for and infusion, and she had an infusion at her neurologist office. She received Saline with magnesium and Toradol. She received Reglan, DHE, and Decadron. She also tried (withheld) CGRP 50mg and 100mg. She received the second dose 21Apr2021. The second lot was ER8735. She got the first vaccine in her left arm, and the second one in her right. She received the doses at 2:15pm. Migraine headache also required visit to Physician office. No prior vaccination within 4 weeks. No other AEs prior to vaccinations. All the blood work at hospital came out normal and kidney function was one marker a little out of normal range. The patient has not recovered from the events.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Migraine, Nausea, Photophobia, Vitamin D
Clinical narrative: neurological symptoms; developed a migraine headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 01Apr2021 14:15 (lot number: ER8737) at the age of 59 years old, as 1ST DOSE SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed a migraine headache on 06Apr2021 and neurological symptoms on an unspecified date. The doctor and neurologist were testing her. Clearly migraines medication can't help it. Her physician is working with her other doctor to try to figure it out. He worked with other patients with long term side effects from the vaccine. She is wondering if there is any literature on migraines as a long-term side effect. She got the first vaccine on 01Apr2021. She started having migraines on 06Apr2021. She has tried taking multiple medications. She has been to the emergency room for and infusion, and she had an infusion at her neurologist office. She received Saline with magnesium and Toradol. She received Reglan, DHE, and Decadron. She also tried (withheld) CGRP 50mg and 100mg. She received the second dose 21Apr2021. The second lot was ER8735. She got the first vaccine in her left arm, and the second one in her right. She received the doses at 2:15pm. Migraine headache also required visit to Physician office. No prior vaccination within 4 weeks. No other AEs prior to vaccinations. All the blood work at hospital came out normal and kidney function was one marker a little out of normal range. The patient has not recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Exfoliative rash, Periorbital swelling, Rash erythematous, Rash vesicular
Clinical narrative: skin blisters; skin peels; eyes are puffy; recurring rash on the cheeks and forehead/cheeks and forehead, get red; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first single dose at the end of Mar2021 and second single dose on an unspecified date, both via an unspecified route of administration (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller reported that about 10 days after she got the first vaccine, she got a recurring rash on the cheeks and forehead, around the second week of April, which comes and goes, and when it comes back, her skin blisters and peels. Caller states it may not be a coincidence, and it started after the first vaccine. Caller states it has continued after the second vaccine. Caller reports that when she gets this rash, her eyes get puffy, and her cheeks and forehead, get red. Caller states the rash goes away and comes back again. Caller states she has ruled out, other causes, like soap, shampoo, makeup and food. Caller states her sister told her it looks like a Lupus butterfly rash, and she believes that she does not have Lupus. Outcome of the events was unknown.   Information about Lot/Batch number cannot be obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Diarrhoea, Gastric disorder, Vomiting
Clinical narrative: developed a swollen stomach; hardness in her stomach; diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07May2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient said she was perfect, perfect, perfect until yesterday (16May2021) and she developed a swollen stomach, hardness in her stomach, diarrhea and vomiting. Her stomach was swollen up to her breasts and felt like it was up to her throat. She did get some sleep and it did go down but since been being on the phone it was swollen up again. She mentioned she didn't take any of her medications yesterday. She took two sugar pills- Farxiga and Januvia, a heart pill Metoprolol 200mg XL, and then three stomach medications Protonix, Pepcid, and Nexium, but she said the Pepcid didn't really do anything. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Arthralgia, Chills, Dehydration, Diarrhoea
Clinical narrative: developed a swollen stomach; hardness in her stomach; diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07May2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient said she was perfect, perfect, perfect until yesterday (16May2021) and she developed a swollen stomach, hardness in her stomach, diarrhea and vomiting. Her stomach was swollen up to her breasts and felt like it was up to her throat. She did get some sleep and it did go down but since been being on the phone it was swollen up again. She mentioned she didn't take any of her medications yesterday. She took two sugar pills- Farxiga and Januvia, a heart pill Metoprolol 200mg XL, and then three stomach medications Protonix, Pepcid, and Nexium, but she said the Pepcid didn't really do anything. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hot flush, Infusion site joint swelling, Lymphadenopathy, Malaise
Clinical narrative: developed a swollen stomach; hardness in her stomach; diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07May2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient said she was perfect, perfect, perfect until yesterday (16May2021) and she developed a swollen stomach, hardness in her stomach, diarrhea and vomiting. Her stomach was swollen up to her breasts and felt like it was up to her throat. She did get some sleep and it did go down but since been being on the phone it was swollen up again. She mentioned she didn't take any of her medications yesterday. She took two sugar pills- Farxiga and Januvia, a heart pill Metoprolol 200mg XL, and then three stomach medications Protonix, Pepcid, and Nexium, but she said the Pepcid didn't really do anything. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Vaccination site swelling, Vomiting
Clinical narrative: developed a swollen stomach; hardness in her stomach; diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07May2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient said she was perfect, perfect, perfect until yesterday (16May2021) and she developed a swollen stomach, hardness in her stomach, diarrhea and vomiting. Her stomach was swollen up to her breasts and felt like it was up to her throat. She did get some sleep and it did go down but since been being on the phone it was swollen up again. She mentioned she didn't take any of her medications yesterday. She took two sugar pills- Farxiga and Januvia, a heart pill Metoprolol 200mg XL, and then three stomach medications Protonix, Pepcid, and Nexium, but she said the Pepcid didn't really do anything. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis, SARS-CoV-2 test
Clinical narrative: Dx with autoimmune disease first time in my life with Multiple Sclerosis post second shot became symptomatic for MS hospitalized had work up post 2nd injection.; This is a spontaneous report from a contactable nurse (patient). A 43-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jan2021 (Lot Number: Ek9231) in Deltoid as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on 22Dec2020 20:00 (lot number: Ek5730) in right arm for covid-19 immunisation. The patient experienced Dx with autoimmune disease first time in her life with Multiple Sclerosis post second shot became symptomatic for MS hospitalized had work up post 2nd injection on 17Jan2021. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient hospitalized for 28 days and received treatment. The patient had COVID tested post vaccination (Nasal swab) with unknown results. The outcome was unknown.; Sender's Comments: Based on the temporal relationship, the association between the event multiple sclerosis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria
Clinical narrative: Chronic idiopathic urticaria/itchy under-skin lumps/Also lines and streaks on arms and back; This is a spontaneous report from a contactable consumer reported for herself. This 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Feb2021 02:30 PM (lot number=EN6203) in left arm at single dose for COVID-19 immunization. Medical history included osteoporosis, prolapsed bladder, Polio as a toddler, allergies with food/inhalants, stopped 20 yrs ago. Concomitant medications included tolterodine, raloxifene.  The patient previously experienced allergies with levofloxacin (LEVAQUIN), ciprofloxacin hydrochloride (CIPRO), neomycin, diphenhydramine hydrochloride (BENADRYL), polymyxin b sulfate.  On 02Mar2021 08:00 AM, the patient experienced first itchy under-skin lumps appeared on thigh/buttocks junction on awakening. Since then .5 to 1 inch bumps had appeared in same area, knees, back, torso, arms, and feet. Also lines and streaks on arms and back. Two raised bumps on forehead and 2 inch square on hairline/forehead. All disappear few hours later. Patient took loratadine (CLARITIN), recommended by PCP. Seen by allergist 29April. Diagnosed with chronic idiopathic urticaria. Prescribed fexofenadine hydrochloride (ALLEGRA). Added famotidine (PEPCID AC) twice daily by PCP. Only 5 days without presentation since start. The event resulted in Doctor or other healthcare professional office/clinic visit. Additional treatment included antihistamines, cortisone cream, both OTC. The 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, patient has not been tested for COVID-19 since the vaccination. Outcome of event was not recovered.   Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Facial discomfort
Clinical narrative: stomach pain; face breaking out; This is a spontaneous report from a consumer (patient father). This consumer reported for 25 years old female patient(daughter). A 25 years and 11 months old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had first dose of the vaccine three weeks ago and had a very bad reaction to it. She had quite bad stomach pain for about three weeks, face breaking out and is not willing to get the second shot. Patient father wanted to know the efficacy of the first dose and how long will it last and if his daughter changes her mind, is the recommended interval between the first dose and second dose. He is asking if his daughter can get the Johnson & Johnson COVID Vaccine. Patient second dose was in the middle of this month (15 th). The outcome of the events was unknown.  Information about batch/Lot number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Thrombosis
Clinical narrative: Bruises on my thighs, looks like blood clots; Bruises on my thighs, looks like blood clots; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Left Arm on 17Apr2021 11:00 at the age of 42-years-old as single dose for covid-19 immunisation. Medical history included anaemia, iron deficiency. No known allergies. Patient was not pregnant, not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included iron, other vitamins such as biotin and minerals nos, vitamins nos (PRENATAL VITAMINS) within 2 weeks of vaccination.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced bruises on thighs, looked like blood clots on 17Apr2021. No treatment received for the events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered. The events assessed as non-serious.  Information on the lot/batch number has been requested.