chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Headache
Clinical narrative: Headache; Extreme body fatigue; Muscle aches; Had difficulty sitting up or lying down unless lying on a hard floor; Felt like I was going to pass out; Heart palpitations; Two panic attacks; Chest pains/Felt like heart attack; Shortness of breath/Felt like heart attack; Increased severe anxiety; Depression; This is a spontaneous report from a contactable Healthcare Professional. A non-pregnant 51-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration, in left arm on 29Mar2021 10:15, at 51 years of age, (Batch/Lot Number: ER8733) as single dose, for COVID-19 immunization. Medical history included hyperthyroidism, allergy to shrimp, menopause and allergy to IV dye, all from an unknown date. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (Batch/Lot Number: EN6206) on 08Mar2021 10:00 AM, at 51 years of age, administered in left arm. Concomitant medications included levothyroxine 25 mcg, progesterone and estradiol, all taken for an unspecified indication, since an unknown date. The patient didn't receive any other vaccine in the previous 4 weeks. She wasn't diagnosed with COVID-19 before vaccination. The patient reported that on 29Mar2021, after the second dose she had severe headache; extreme body fatigue; muscle aches; and had difficulty sitting up or lying down unless lying on a hard floor for the first 3-4 days after vaccine. For 3 weeks she continued to have severe continual headache; extreme body fatigue where if she tried to exercise or simply walk dog or go up flight of stairs she felt like she was going to pass out; she also had heart palpitations and two panic attacks, all of these symptoms lasted 3 weeks after vaccine. She went to the emergency room twice: once for headache and chest pains (as she felt like heart attack); second time it was for shortness of breath, again she felt like heart attack, she had to call for an ambulance. All these instances increased severe anxiety and panic and interfered with her work and daily functioning until 24Apr2021. She then began to feel herself again. However, she was still experiencing anxiety, depression, and panic at times. The patient underwent lab tests and procedures on an unknown date in 2021, which included CT scan, chest X-ray and EKG, with unknown results. The patient was tested for COVID-19 via nasal swab on 23Apr2021, which was negative. The patient was treated with headache medication. The events headache, extreme body fatigue, muscle aches, had difficulty sitting up or lying down unless lying on a hard floor, felt like i was going to pass out, heart palpitations, chest pains and shortness of breath recovered with sequelae on an unknown date, whereas the events two panic attacks, increased severe anxiety and depression had not resolved yet at the time of the report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Palpitations, Panic attack, SARS-CoV-2 test, Sitting disability
Clinical narrative: Headache; Extreme body fatigue; Muscle aches; Had difficulty sitting up or lying down unless lying on a hard floor; Felt like I was going to pass out; Heart palpitations; Two panic attacks; Chest pains/Felt like heart attack; Shortness of breath/Felt like heart attack; Increased severe anxiety; Depression; This is a spontaneous report from a contactable Healthcare Professional. A non-pregnant 51-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration, in left arm on 29Mar2021 10:15, at 51 years of age, (Batch/Lot Number: ER8733) as single dose, for COVID-19 immunization. Medical history included hyperthyroidism, allergy to shrimp, menopause and allergy to IV dye, all from an unknown date. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (Batch/Lot Number: EN6206) on 08Mar2021 10:00 AM, at 51 years of age, administered in left arm. Concomitant medications included levothyroxine 25 mcg, progesterone and estradiol, all taken for an unspecified indication, since an unknown date. The patient didn't receive any other vaccine in the previous 4 weeks. She wasn't diagnosed with COVID-19 before vaccination. The patient reported that on 29Mar2021, after the second dose she had severe headache; extreme body fatigue; muscle aches; and had difficulty sitting up or lying down unless lying on a hard floor for the first 3-4 days after vaccine. For 3 weeks she continued to have severe continual headache; extreme body fatigue where if she tried to exercise or simply walk dog or go up flight of stairs she felt like she was going to pass out; she also had heart palpitations and two panic attacks, all of these symptoms lasted 3 weeks after vaccine. She went to the emergency room twice: once for headache and chest pains (as she felt like heart attack); second time it was for shortness of breath, again she felt like heart attack, she had to call for an ambulance. All these instances increased severe anxiety and panic and interfered with her work and daily functioning until 24Apr2021. She then began to feel herself again. However, she was still experiencing anxiety, depression, and panic at times. The patient underwent lab tests and procedures on an unknown date in 2021, which included CT scan, chest X-ray and EKG, with unknown results. The patient was tested for COVID-19 via nasal swab on 23Apr2021, which was negative. The patient was treated with headache medication. The events headache, extreme body fatigue, muscle aches, had difficulty sitting up or lying down unless lying on a hard floor, felt like i was going to pass out, heart palpitations, chest pains and shortness of breath recovered with sequelae on an unknown date, whereas the events two panic attacks, increased severe anxiety and depression had not resolved yet at the time of the report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: Extreme bout of Raynaud's (primary) in right hand; This is a spontaneous report from a non-contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in Arm Left on 04May2021 08:30 (Batch/Lot Number: EW0150) as unknown, single for covid-19 immunisation. Medical history included very occasional Raynaud's (primary) usually in chilly conditions. The patient concomitant medication was not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 04May2021 09:30, the patient experienced extreme bout of Raynaud's (primary) in right hand. The patient reported it was probably triggered by very brief visit to frozen section of grocery store. The patient reported that her fingers numb and turned dark blue (rather than the usual white) and base of thumb also turned dark blue and feeling numb. The patient drive home and applied warm water, which relieved attack. The patient stated that it was first time in 40 years she had a Raynaud's attack that has been swift and severe. The outcome of the event was recovered on unspecified date in May2021.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a contactable consumer (wife). A 58-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 14May2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 19May2021, 5 days after vaccination, the patient was tested positive for COVID. She received her first COVID vaccine on 14May2021 but was exposed to COVID on the same day. The reporter asked for guidance on when she can receive her second vaccine dose. The reporter stated that they already spoke with her HCP who instructed her to get the second dose as soon as possible. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 12May2021, SARS-COV-2 test: positive on 19May2021. The clinical outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac murmur, Physical examination
Clinical narrative: little murmur in [his] heart; This is a spontaneous report from a contactable consumer(patient). This 84-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0158) on 01Jun2021 via an unknown route in right arm at 84-year-old for Covid-19 immunization. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0150) on 11May2021 at 84-year-old for Covid-19 immunization.  Patient had an echocardiogram scheduled this Wednesday, 06Jun2021, and further reported had scheduled for an echocardiogram on 09Jun2021; due to a "little murmur in [his] heart", which his doctor noted during his physical exam a couple days ago.  The Patient stated that he heard from other people that they don't recommend any other scans after receiving the second dose of the vaccine, and inquired if it's safe in getting his scheduled echocardiogram. Outcome of the event was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Blood triglycerides, Body temperature, Body temperature abnormal, Erythema
Clinical narrative: broke out a rash all over her face/ bad rash on her face under her eye from her ear to ear down her throat/it was burning/it itch; This is a spontaneous report from a contactable consumer (patient) reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0191), via an unspecified route of administration, administered in arm left on 02Jun2021 (at the age of 75-years-old) as 1st dose, single for covid-19 immunization. The patient medical history included allergies, had a UTI and a bad tooth that needs to be pulled. The patient was taking blood pressure pills and stuff, have been taking two antibiotics. On an unspecified date, the patient broke out a rash all over her face. Have really bad rash on her face under her eye from her ear to ear down her throat. It was burning and she have put allergen gel on it and that's seemed to sooth it, because it itch so bad and she took a Benadryl long ago. The outcome of the event was not recovered.   Information on lot/batch number was available. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling hot, Pruritus, Rash, Scratch
Clinical narrative: broke out a rash all over her face/ bad rash on her face under her eye from her ear to ear down her throat/it was burning/it itch; This is a spontaneous report from a contactable consumer (patient) reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0191), via an unspecified route of administration, administered in arm left on 02Jun2021 (at the age of 75-years-old) as 1st dose, single for covid-19 immunization. The patient medical history included allergies, had a UTI and a bad tooth that needs to be pulled. The patient was taking blood pressure pills and stuff, have been taking two antibiotics. On an unspecified date, the patient broke out a rash all over her face. Have really bad rash on her face under her eye from her ear to ear down her throat. It was burning and she have put allergen gel on it and that's seemed to sooth it, because it itch so bad and she took a Benadryl long ago. The outcome of the event was not recovered.   Information on lot/batch number was available. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Urticaria, X-ray
Clinical narrative: broke out a rash all over her face/ bad rash on her face under her eye from her ear to ear down her throat/it was burning/it itch; This is a spontaneous report from a contactable consumer (patient) reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0191), via an unspecified route of administration, administered in arm left on 02Jun2021 (at the age of 75-years-old) as 1st dose, single for covid-19 immunization. The patient medical history included allergies, had a UTI and a bad tooth that needs to be pulled. The patient was taking blood pressure pills and stuff, have been taking two antibiotics. On an unspecified date, the patient broke out a rash all over her face. Have really bad rash on her face under her eye from her ear to ear down her throat. It was burning and she have put allergen gel on it and that's seemed to sooth it, because it itch so bad and she took a Benadryl long ago. The outcome of the event was not recovered.   Information on lot/batch number was available. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: broke out a rash all over her face/ bad rash on her face under her eye from her ear to ear down her throat/it was burning/it itch; This is a spontaneous report from a contactable consumer (patient) reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0191), via an unspecified route of administration, administered in arm left on 02Jun2021 (at the age of 75-years-old) as 1st dose, single for covid-19 immunization. The patient medical history included allergies, had a UTI and a bad tooth that needs to be pulled. The patient was taking blood pressure pills and stuff, have been taking two antibiotics. On an unspecified date, the patient broke out a rash all over her face. Have really bad rash on her face under her eye from her ear to ear down her throat. It was burning and she have put allergen gel on it and that's seemed to sooth it, because it itch so bad and she took a Benadryl long ago. The outcome of the event was not recovered.   Information on lot/batch number was available. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chest X-ray, Computerised tomogram, Fatigue
Clinical narrative: fever of 102, fever was getting higher as 102.6; fatigue; headaches; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program COVAX US Support. This 42-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in left arm on 27May2021 at 14:00, at patient age of 46-year-old, as single dose (Lot number EW0178, Expiry Date: Aug 2021) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no other medical history and no known allergies. The patient's concomitant medications included gabapentin, quetiapine fumarate (SEROQUEL), chloroquine. The patient had no past drug reaction. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced the adverse events from 01Jun2021. The patient got a high fever of 102 which had lasted a week and it was not getting any better. The patient also experienced headache and fatigue. The patient went to the emergency room on 07Jun2021, where they did blood work and a chest X-ray and a CT scan. Everything came back normal and they can not figure out why he had this persistent high fever. The patient wanted to know how long this is going to last or what was going on. On 08Jun2021, the patient reported fever was getting higher as 102.6. It was going up little more everyday. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Covid test post vaccination included Rapid test on 05Jun2021 showed negative (Nasal Swab); Non rapid test on 07Jun2021 showed negative (Nasal Swab). The patient received treatment including paracetamol (ACETAMINOPHEN), ibuprofen (MOTRIN), Ibuprofen. The outcome of the events was not resolved.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever of 102, fever was getting higher as 102.6; fatigue; headaches; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program COVAX US Support. This 42-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in left arm on 27May2021 at 14:00, at patient age of 46-year-old, as single dose (Lot number EW0178, Expiry Date: Aug 2021) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no other medical history and no known allergies. The patient's concomitant medications included gabapentin, quetiapine fumarate (SEROQUEL), chloroquine. The patient had no past drug reaction. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced the adverse events from 01Jun2021. The patient got a high fever of 102 which had lasted a week and it was not getting any better. The patient also experienced headache and fatigue. The patient went to the emergency room on 07Jun2021, where they did blood work and a chest X-ray and a CT scan. Everything came back normal and they can not figure out why he had this persistent high fever. The patient wanted to know how long this is going to last or what was going on. On 08Jun2021, the patient reported fever was getting higher as 102.6. It was going up little more everyday. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Covid test post vaccination included Rapid test on 05Jun2021 showed negative (Nasal Swab); Non rapid test on 07Jun2021 showed negative (Nasal Swab). The patient received treatment including paracetamol (ACETAMINOPHEN), ibuprofen (MOTRIN), Ibuprofen. The outcome of the events was not resolved.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Electrocardiogram, Hepatic enzyme increased, Inappropriate schedule of product administration
Clinical narrative: extreme discomfort in her chest; liver enzyme that normal is 40 and it was 110; Dose Number : 1; Date of start of drug: 16Apr2021; Dose Number : 2; Date of start of drug: 28May2021; This is a spontaneous report from a contactable consumer (patient's mother). This is the second of two reported. This report concerns events occurred after the second dose. A 16-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0180), administered in left arm, on 28May2021 at 18:00 (at the age of 16-years-old) at dose 2, single for COVID-19 immunization. The patient was not pregnant. Medical history included ichthyosis vulgaris. No COVID prior vaccination and no COVID tested post vaccination. The patient had not known allergies. Concomitant medications were not reported. No other vaccines were received in four weeks and no other medications in two weeks. The patient received the first dose of BNT162b2 (lot number: EW0164) on 16Apr2021 at 13:30, at the age of 16-years-old, administered in right arm for COVID-19 immunization and experienced extreme radiating nerve pain in her arm to her fingertips. The reporter purposely waited 6 weeks for her second vaccine because she had adverse reactions to her first. The patient suffered extreme discomfort in her chest on 01Jun2021 at 03:00 AM. She described it as something sitting on her chest not allowing air in at a level 7 w 10 being dead. She had been taken to emergency room (ER) immediately. There she received an EKG, heart and lung scan and bloodwork on 01Jun2021. All that showed up was a liver enzyme that normal was 40 and it was 110, on 01Jun2021 at 03:00 AM. No treatment was administered in response to the events. The events were reported as non-serious and they required emergency room/department or urgent care visit. The patient had recovered from the events extreme discomfort in her chest and liver enzyme that normal is 40 and it was 110 in Jun2021, the outcome of the other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021669577 same patient/drug, different doses/events
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Scan myocardial perfusion, Ventilation/perfusion scan
Clinical narrative: extreme discomfort in her chest; liver enzyme that normal is 40 and it was 110; Dose Number : 1; Date of start of drug: 16Apr2021; Dose Number : 2; Date of start of drug: 28May2021; This is a spontaneous report from a contactable consumer (patient's mother). This is the second of two reported. This report concerns events occurred after the second dose. A 16-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0180), administered in left arm, on 28May2021 at 18:00 (at the age of 16-years-old) at dose 2, single for COVID-19 immunization. The patient was not pregnant. Medical history included ichthyosis vulgaris. No COVID prior vaccination and no COVID tested post vaccination. The patient had not known allergies. Concomitant medications were not reported. No other vaccines were received in four weeks and no other medications in two weeks. The patient received the first dose of BNT162b2 (lot number: EW0164) on 16Apr2021 at 13:30, at the age of 16-years-old, administered in right arm for COVID-19 immunization and experienced extreme radiating nerve pain in her arm to her fingertips. The reporter purposely waited 6 weeks for her second vaccine because she had adverse reactions to her first. The patient suffered extreme discomfort in her chest on 01Jun2021 at 03:00 AM. She described it as something sitting on her chest not allowing air in at a level 7 w 10 being dead. She had been taken to emergency room (ER) immediately. There she received an EKG, heart and lung scan and bloodwork on 01Jun2021. All that showed up was a liver enzyme that normal was 40 and it was 110, on 01Jun2021 at 03:00 AM. No treatment was administered in response to the events. The events were reported as non-serious and they required emergency room/department or urgent care visit. The patient had recovered from the events extreme discomfort in her chest and liver enzyme that normal is 40 and it was 110 in Jun2021, the outcome of the other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021669577 same patient/drug, different doses/events
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Overdose, Pain in extremity, Product preparation issue
Clinical narrative: Her arm is just sore this time and she is tired; Her arm is just sore this time and she is tired; His daughter received twice the dose/ They put two and a half dosage given and they didn't diluted it correctly; They put two and a half dosage given and they didn't diluted it correctly; This is a spontaneous report from a contactable consumer (patient's father/ parent). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jun2021 (9:00 or 09:10 this morning AM) (Lot Number: EW0180; Expiration Date: 01Aug2021) as single dose (at the age of 15-years-old) for COVID-19 immunization. Medical history included allergic to peaches. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 16:00 (Lot Number: EW0167) as single dose (at the age of 15-years-old) for COVID-19 immunization. The patient received the second dose today (of the vaccine) and father was notified by the pharmacist that she received twice the dose of the vaccine today. The pharmacist called and said they put two and a half dosage given and they didn't diluted it correctly. Her arm is just sore this time and she is tired. She got her first shot and it was fine then. The patient underwent lab tests and procedures which included body temperature: fine on 07Jun2021. The patient did not receive any treatment for the events. The outcome of the events was unknown. The events were assessed as non-serious. The patient did not have any other vaccine after COVID vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable nurse. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 03Jun2021 at 09:03 (Batch/Lot Number: EW0180) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included Psoriatic arthritis, Psoriasis and an autoimmune disorder. Concomitant medication included secukinumab (COSENTYX) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the right arm on 10May2021 at 10:16 (Batch/Lot Number: EW0173) as 1ST DOSE, SINGLE for COVID-19 immunisation, and didn't have reaction with that shot. The patient had no prior vaccination within 4 weeks. The patient called to report that she got her second shot and it's not dangerous like threatening or death or anything like that, but she did come down with shingles after her second vaccination. When probed for permission to probe, the patient added that it was totally fine. She just wanted to make sure she reported it, because she thought it would probably be tracked for people with autoimmune issue. When asked regarding the causality, the nurse (patient) agreed that it is, but there was more to it than just that. She added that she was immunocompromised, she has an autoimmune disorder, and have psoriatic arthritis for which she is treated and at a higher risk for side effect. The nurse added that she did get a confirmation from her primary care doctor. She did guarantee the day before and did confirm it was shingles. Treatment for the adverse effects included some steroid. The patient added that she was on Nitropack (not clarified further) right, and on Acyclovir which has helped tremendously with the side effect. With regards to the lab test, the nurse stated that she didn't need any, they were able to look at it, and they were able to examine her. The blisters were very apparent that it was not psoriasis and that it was shingles because it looks very different from her psoriasis, and it follows the pattern which shingles does. The patient also stated that she just wanted to make sure that they get this information so that they can keep tracking more and more. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pretty high temperature; This is a spontaneous report from a contactable consumer (parent). A 19-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm, on 06Jun2021 at 14:00 (at the age of 19 years old) as 1st dose, single for COVID-19 immunisation. Medical history included diabetes and asthma. Concomitant medications included insulin lispro (HUMALOG); and, insulin glargine (LANTUS), both were taken for an unspecified indication, start and stop date were not reported. The patient has no prior vaccination within 4 weeks. On 06Jun2021, about 5 or 6 hours ago, it was reported that the patient experienced pretty high temperature, and they wanted to know if that's an after effect of the shot because it's not listed in the side effects. The treatment for the adverse event was just a rest (as reported). The outcome of the event was unknown.   Information about batch/Lot number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Diarrhoea, Dizziness, Feeling hot, Flushing
Clinical narrative: During day of 6/7, was able to keep down a little food, but still experiencing nausea; diarrhea; Range of motion in arm was also quite limited; could not engage in normal activities; Nauseated; arm was very sore; bouts of dizziness which continued for next two days; felt very hot; face flushed; This is a spontaneous report from a contactable consumer (patient).  A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Jun2021 17:45 (Batch/Lot Number: EW0171) age at vaccination of 38-years-old, as single dose, for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (Prior to vaccination). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid (VIT-C) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; calcium citrate (CALCIUM CITRATE) taken for an unspecified indication, start and stop date were not reported and multivitamin for an unspecified indication, start and stop date were not reported. The patient previously took trimox ketone and experienced drug hypersensitivity.  Immediately after shot, on 04Jun2021 18:00, the patient felt very hot and face flushed; then approximately 1 hour after, had bouts of dizziness which continued for next two days. During the evening of 05Jun2021, became nauseated (and arm was very sore), and most of day during 06Jun2021, had diarrhea and additional nausea, could not engage in normal activities and range of motion in arm was also quite limited. During day of 07Jun2021, was able to keep down a little food, but still experiencing nausea. No treatments were given for the events. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: During day of 6/7, was able to keep down a little food, but still experiencing nausea; diarrhea; Range of motion in arm was also quite limited; could not engage in normal activities; Nauseated; arm was very sore; bouts of dizziness which continued for next two days; felt very hot; face flushed; This is a spontaneous report from a contactable consumer (patient).  A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Jun2021 17:45 (Batch/Lot Number: EW0171) age at vaccination of 38-years-old, as single dose, for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (Prior to vaccination). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid (VIT-C) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; calcium citrate (CALCIUM CITRATE) taken for an unspecified indication, start and stop date were not reported and multivitamin for an unspecified indication, start and stop date were not reported. The patient previously took trimox ketone and experienced drug hypersensitivity.  Immediately after shot, on 04Jun2021 18:00, the patient felt very hot and face flushed; then approximately 1 hour after, had bouts of dizziness which continued for next two days. During the evening of 05Jun2021, became nauseated (and arm was very sore), and most of day during 06Jun2021, had diarrhea and additional nausea, could not engage in normal activities and range of motion in arm was also quite limited. During day of 07Jun2021, was able to keep down a little food, but still experiencing nausea. No treatments were given for the events. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Skin warm
Clinical narrative: rash down three quarters of left arm; Arm  was hot, very itchy and red; Arm was hot, very itchy and red; Arm was hot, very itchy and red; This is a spontaneous report from a non-contactable consumer (patient) received via a sales representative. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 03Jun2021 (batch/lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included Psoriatic Arthritis. Concomitant medication included infliximab (REMICADE). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, on 13May2021 at the age of 68- years in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 06Jun2021, the patient experienced rash down three quarters of left arm, arm was hot, very itchy and red. Therapeutic measures were taken as the result of the events which included treatment with Advil and Benadryl. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were considered non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Scratch, Urticaria, Vaccination site erythema
Clinical narrative: Small hives around her wrist on the same arm received the vaccine/ hives on my lower abdomen, near my diaphragm, back of my legs, thighs and arms again; Itchiness on both of the arms; Some redness/ getting red on my wrist that I was vaccinated on my left wrist and then on my right arm; I am scratching it my skin and kind of broke out in some slight hives, small little hives and getting red; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: GW0177), via an unspecified route of administration, administered in left arm on 01Jun2021 16:30 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no prior vaccination within 4 weeks. The vaccination facility type was pharmacy/drug store. One week after getting the vaccine on Sunday (06Jun2021), the patient had some small hives on her wrist (same arm that received the vaccine) and it was itching in both arms. She took some Benadryl and the itching ceased but there was still some redness. The patient had woke up in the middle of the night of 06Jun2021 and she was scratching it her skin and kind of broke out in some slight hives, small little hives and getting red on her wrist that she was vaccinated on her left wrist and then on her right arm she was kind of breaking out and scratching kind of hard. She took a half of a Benadryl cleared it up and then the very next day she ended up breaking out. She had hives again on her left wrist abdomen and the back of her legs. The next day, she had hives on her lower abdomen, near her diaphragm, back of my legs, thighs and arms again. She spoke with her doctor and he said to call Pfizer to report the side effects and wanted to know if she should get the 2nd dose. She is scheduled for the 2nd dose on 22Jun2021. Therapeutic measures were taken as a result of the events and included treatment with Benadryl (formulation not specified). The outcome of the events hives, itching, and vaccination site erythema were recovered on 08Jun2021, and for the event scratch was recovered on Jun2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Tinnitus
Clinical narrative: Chills; Severe headache; Really bad tinnitus; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in left arm on 16Apr2021 15:00 (at the age of 65 years old) as dose 1, single for COVID-19 immunization. Medical history included mildly high blood pressure, and Sulfa-based drugs allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid (ASPIRIN 81); hydrochlorothiazide; and losartan, all taken for an unspecified indication. The patient previously took aspartame and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. After vaccination, on 17Apr2021, the patient woke up at 01:30 AM with chills and a severe headache. The symptoms disappeared the next day, but still have mild headaches and noticed really bad tinnitus several days later on an unspecified date in 2021. No treatment was received for the events. The outcome of the event really bad tinnitus was unknown, and for other events was recovered with sequel. The patient received the second dose of BNT162B2 on 07May2021 15:00, for COVID-19 immunization.
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Blood test, Hepatic enzyme, Hepatic enzyme increased
Clinical narrative: elevated liver enzymes; ALT is in the upper range; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient stated that he was having an adverse reaction that was not listed on "the site" and was not a general reaction. He said that he had a lot of reactions but he was most concerned about his elevated liver enzymes. He had a blood test 3 days after getting the first dose of the Pfizer COVID-19 vaccine and his ALT was in the upper range. He did another blood test 2 months later and his ALT level barely came down. He wanted to know all the information from Pfizer about having an elevated ALT level after vaccination. He talked to his hepatologist, he had an elevated ALT score that they were concerned about and it was remained elevated in the upper range for about 2 months now following the vaccine. He had also had a bunch of other side effects but the most concerning for him was his liver and he thought there was a link because he had done a lot of enzyme test, liver panel over the last 15 years and he had never seen this level of ALT on his liver health before his life and this blood test had taken 3 days after he received first dose of Pfizer vaccine. The outcome of the events was unknown.  Information regarding the Lot/Batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Antinuclear antibody, Blood albumin, Blood bilirubin, Blood bilirubin increased
Clinical narrative: where RUQ tenderness was noted on exam; BILI was 1.1; C-reactive protein (CRP) 25.8; She had persistent circulation sxs in her feet/ persistent Raynaud's type sxs primarily; her toes felt numb; patient noticed her toes felt numb, looked purplish; patient noticed her toes felt numb, looked purplish, and were cold; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; This is a spontaneous report from a contactable Physician. A 38-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 38-year-old, via intramuscular on 05May2021 as single dose for COVID-19 immunisation.  Medical history included morbid obesity, fibromyalgia, Post-traumatic stress disorder (PTSD), Anxiety, Attention deficit hyperactivity disorder (ADD), depression, prehypertensiony. Known allergies: cefixime (FLEXERIL), tape. The patient previously received the first dose of BNT162B2 on 14Apr2021 at the age of 38-year-old, for COVID-19 immunization. Concomitant medications included bifidobacterium infantis (ALIGN); ergocalciferol (VIT D); iron; magnesium. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Clinical course: On 19May2021 the patient noticed her toes felt numb, looked purplish, and were cold.  She took a shower, then spiked a fever > 101 with chills and myalgias. 48 hours later her fever was improved and she went for a COVID test (on 21May2021), which was negative. She had persistent circulation sxs in her feet. The reporter saw her on office on 25May2021, where RUQ tenderness was noted on exam. Labs were significant for white blood count (WBC) 8.0 with normal difference, Blood albumin (ALB) 3.3, Blood bilirubin (BILI) 0.3, C-reactive protein (CRP) 25.8, Red blood cell sedimentation rate (ESR) 54, normal Urine analysis (UA), Antinuclear antibody (ANA) 1:80 with a cytoplasmic pattern, neg cascade. Ultrasound abdomen (Abd U/S) was negative. Repeat labs 03Jun2021 her CRP was now 9.3 and BILI was 1.1, otherwise negative CBC and CMP.  Patient seen 08Jun2021 with persistent Raynaud's type sxs primarily. Repeat labs pending at the time of this report. The events were reported as non-serious. No treatment received for the events. The events resulted in physician office visit. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, C-reactive protein, C-reactive protein increased, Chills, Full blood count
Clinical narrative: where RUQ tenderness was noted on exam; BILI was 1.1; C-reactive protein (CRP) 25.8; She had persistent circulation sxs in her feet/ persistent Raynaud's type sxs primarily; her toes felt numb; patient noticed her toes felt numb, looked purplish; patient noticed her toes felt numb, looked purplish, and were cold; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; This is a spontaneous report from a contactable Physician. A 38-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 38-year-old, via intramuscular on 05May2021 as single dose for COVID-19 immunisation.  Medical history included morbid obesity, fibromyalgia, Post-traumatic stress disorder (PTSD), Anxiety, Attention deficit hyperactivity disorder (ADD), depression, prehypertensiony. Known allergies: cefixime (FLEXERIL), tape. The patient previously received the first dose of BNT162B2 on 14Apr2021 at the age of 38-year-old, for COVID-19 immunization. Concomitant medications included bifidobacterium infantis (ALIGN); ergocalciferol (VIT D); iron; magnesium. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Clinical course: On 19May2021 the patient noticed her toes felt numb, looked purplish, and were cold.  She took a shower, then spiked a fever > 101 with chills and myalgias. 48 hours later her fever was improved and she went for a COVID test (on 21May2021), which was negative. She had persistent circulation sxs in her feet. The reporter saw her on office on 25May2021, where RUQ tenderness was noted on exam. Labs were significant for white blood count (WBC) 8.0 with normal difference, Blood albumin (ALB) 3.3, Blood bilirubin (BILI) 0.3, C-reactive protein (CRP) 25.8, Red blood cell sedimentation rate (ESR) 54, normal Urine analysis (UA), Antinuclear antibody (ANA) 1:80 with a cytoplasmic pattern, neg cascade. Ultrasound abdomen (Abd U/S) was negative. Repeat labs 03Jun2021 her CRP was now 9.3 and BILI was 1.1, otherwise negative CBC and CMP.  Patient seen 08Jun2021 with persistent Raynaud's type sxs primarily. Repeat labs pending at the time of this report. The events were reported as non-serious. No treatment received for the events. The events resulted in physician office visit. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Investigation, Metabolic function test, Myalgia, Peripheral coldness
Clinical narrative: where RUQ tenderness was noted on exam; BILI was 1.1; C-reactive protein (CRP) 25.8; She had persistent circulation sxs in her feet/ persistent Raynaud's type sxs primarily; her toes felt numb; patient noticed her toes felt numb, looked purplish; patient noticed her toes felt numb, looked purplish, and were cold; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; This is a spontaneous report from a contactable Physician. A 38-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 38-year-old, via intramuscular on 05May2021 as single dose for COVID-19 immunisation.  Medical history included morbid obesity, fibromyalgia, Post-traumatic stress disorder (PTSD), Anxiety, Attention deficit hyperactivity disorder (ADD), depression, prehypertensiony. Known allergies: cefixime (FLEXERIL), tape. The patient previously received the first dose of BNT162B2 on 14Apr2021 at the age of 38-year-old, for COVID-19 immunization. Concomitant medications included bifidobacterium infantis (ALIGN); ergocalciferol (VIT D); iron; magnesium. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Clinical course: On 19May2021 the patient noticed her toes felt numb, looked purplish, and were cold.  She took a shower, then spiked a fever > 101 with chills and myalgias. 48 hours later her fever was improved and she went for a COVID test (on 21May2021), which was negative. She had persistent circulation sxs in her feet. The reporter saw her on office on 25May2021, where RUQ tenderness was noted on exam. Labs were significant for white blood count (WBC) 8.0 with normal difference, Blood albumin (ALB) 3.3, Blood bilirubin (BILI) 0.3, C-reactive protein (CRP) 25.8, Red blood cell sedimentation rate (ESR) 54, normal Urine analysis (UA), Antinuclear antibody (ANA) 1:80 with a cytoplasmic pattern, neg cascade. Ultrasound abdomen (Abd U/S) was negative. Repeat labs 03Jun2021 her CRP was now 9.3 and BILI was 1.1, otherwise negative CBC and CMP.  Patient seen 08Jun2021 with persistent Raynaud's type sxs primarily. Repeat labs pending at the time of this report. The events were reported as non-serious. No treatment received for the events. The events resulted in physician office visit. The outcome of the events was recovering.  Information on the lot/batch number has been requested.