chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Fluid retention, Transient ischaemic attack
Clinical narrative: a possible transient ischaemic attack; the patient began retaining water; This is a spontaneous report from a non-contactable consumer (patient).   An 87-year-old male patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 19Jan2021 for Covid-19 immunisation. Medical history included mitral valve replacement, pacemaker. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included blood thinner, atorvastatin calcium (STATIN), lisinopril (manufacturer unknown), warfarin (manufacturer unknown).  No other vaccine received in four weeks. In 2021 a few days after 1st vaccination the patient began retaining water. On 04Feb2021 the patient was hospitalized for a possible transient ischemic attack. The patient was hospitalized for a possible transient ischaemic attack and began retaining water from 04Feb2021 to an unknown date. Therapeutic measures were taken as a result of events. The outcome of unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Swelling face, Urticaria
Clinical narrative: systematic allergic reaction that is still on going; Exactly two weeks after taking the first shot my body broke out in systematic rash; welts with swelling of face.; welts with swelling of face.; This is a spontaneous report from a contactable Other HCP (patient himself). A 38-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EH9899, expiration date not reported) intramuscular on left arm on 28Dec2020 at a single dose, then second dose (lot no. EK9231, expiry date not reported), intramuscular on right arm on 18Jan2021 at a single dose for covid-19 immunization. Medical history included known allergies: penicillin. (no major history of allergic reactions except penicillin as a baby). The patient's concomitant medications were not reported.  The patient reported that on 11Jan2021 15:00 (03:00 PM) "exactly two weeks after taking the first shot, my body broke out in systematic rash and welts with swelling of face. My doctor thought two weeks was two long of a delay for the reaction to be from the vaccine. My doctor thought it might have been some antibiotics I had been on and they gave me prednisone. The prednisone cleared up the reaction before the second shot. I received the second shot (on 18Jan2021 with lot no. EK9231, intramuscular on right arm) and within two hours I had an even worse systematic allergic reaction that is still on going as of today 04Feb2021. The Prednisone is not clearing up the reaction. I am going to have to take short term disability." The adverse events resulted to patient had clinic visit, disability or permanent damage. Patient took prednisone, famotidine, hydroxyzine, and XANAX (because of the prednisone) as treatments. The vaccine was given in the hospital. No other vaccines were given in four weeks.  Outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported allergic reaction manifested with "systematic rash and welts with swelling of face" and the administration of the COVID-19 vaccine, BNT162B2.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Gait disturbance, Headache, Investigation
Clinical narrative: red to blue rash on thigh; short of breath; headache; could hardly walk; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable 75-year-old female consumer (Patient) received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME) (lot number/expiration date: unknown), via unknown route of administration, on 25Jan2021 as a single dose for COVID-19 immunization. Relevant medical history was unknown. Concomitant medications was unknown. On 26Jan2021 patient was admitted to hospital for red to blue rash on thigh and short of breath. She stated she got headache after injection and 2 hrs later she could hardly walk. She was in the hospital for 3 days. Complete cardiac work up and CT scans performed which were all negative. The patient inquired if she should take the second covax. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: red to blue rash on thigh; short of breath; headache; could hardly walk; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable 75-year-old female consumer (Patient) received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME) (lot number/expiration date: unknown), via unknown route of administration, on 25Jan2021 as a single dose for COVID-19 immunization. Relevant medical history was unknown. Concomitant medications was unknown. On 26Jan2021 patient was admitted to hospital for red to blue rash on thigh and short of breath. She stated she got headache after injection and 2 hrs later she could hardly walk. She was in the hospital for 3 days. Complete cardiac work up and CT scans performed which were all negative. The patient inquired if she should take the second covax. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncope; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the right arm on 15Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient is not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) and methylfolate. The patient experienced syncope on 15Jan2021. The event was assessed as serious (medically significant). The outcome of the event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: left armpit in arm tender swollen; left armpit in arm tender swollen; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received her first doe of bnt162b2 (BNT162B2 reported as PFIZER -BIONTECH COVID-19 VACCINE; lot number: Em9810; expiration date: unknown), via an unspecified route of administration left arm on 02Feb2021 10:30 at a single dose for covid-19 immunization. The patient has no medical history and known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included clarithromycin (CLARITIN), zinc, ergocalciferol (VIT D) and vitamins nos (MULTIVITAMINS reported as mtv). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 12:00 AM, the patient had left armpit in arm tender swollen. The events were non-serious, and no treatment was received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Vomiting
Clinical narrative: muscle aches; Nausea/vomiting; Nausea/vomiting; general malaise; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (BNT162B2 reported as COVID-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 03Feb2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced muscle aches, nausea/vomiting and general malaise on an unspecified date. The events were non-serious, and it was unknown if the patient received treatment for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Overdose, Product preparation issue
Clinical narrative: one of vials was accidentally diluted with 2mL of diluent. Instead of 1.8mL; one of vials was accidentally diluted with 2mL of diluent/2 people were vaccinated with it; one of vials was accidentally diluted with 2mL of diluent/2 people were vaccinated with it/received vaccine that was diluted with 2mL instead of 1.8mL; This is a spontaneous report from a contactable pharmacist reported similar events for 2 patients. This is 1st of 2 reports. This Pharmacist reported for a 61-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported NDC number of COVID-19 Vaccine: 59267100001) , via an unspecified route of administration on 03Feb2021 at a single dose (diluted the COVID-19 vaccine with 2mL instead of 1.8mL) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her first dose of BNT162B2 intramuscular (hopefully it was in the arm) as covid-19 immunization. On 03Feb2021, one of vials was accidentally diluted with 2mL of diluent. Instead of 1.8mL, he used a whole 2mL. 2 people were vaccinated with it. Patients received vaccine that was diluted with 2mL instead of 1.8mL. The caller explained she was calling because one of her pharmacists diluted the COVID-19 vaccine with 2mL instead of 1.8mL. The pharmacist did inject two patients and it was their second dose. Caller is calling because she wants to know what the next steps are with the patients. Should they get another dose or what?  Prior vaccinations were reported as unknown. The vaccine was given in a Pharmacy.   Information on the lot/batch number has been requested.; Sender's Comments: The company deems there is not a reasonable possibility that the reported event is related to suspect product BNT162b2. The impacts 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.,Linked Report(s) : US-PFIZER INC-2021126750 same drug/reporter, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chills, Dyspnoea, Ejection fraction, Ejection fraction decreased
Clinical narrative: breathing difficulties; Ejection fraction down to 19 percent and fluid in lungs.; achy; chills; unresponsive; fluid in lungs; Heart is weak/Will be removed fluid from heart; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer Sales Representative. An 8-decade-old (in her 70s) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included surgeries, congestive heart failure (CHF) and cardiac issues (many previous heart issues). Concomitant medications included multiple medications including blood thinners. On the night 1 and day 2, the patient experienced achy and some chills. On night 3, the patient was unresponsive with breathing difficulties. Ejection fraction down to 19 percent and had fluid in lungs. Heart was weak. Intubated and catheter placed. Patient was in cardiac ICU. Responding with hand movements. Would be removed fluid from heart and lungs. The above mentioned events took place after use of product, and required hospitalization. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pulmonary oedema, Unresponsive to stimuli
Clinical narrative: breathing difficulties; Ejection fraction down to 19 percent and fluid in lungs.; achy; chills; unresponsive; fluid in lungs; Heart is weak/Will be removed fluid from heart; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer Sales Representative. An 8-decade-old (in her 70s) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included surgeries, congestive heart failure (CHF) and cardiac issues (many previous heart issues). Concomitant medications included multiple medications including blood thinners. On the night 1 and day 2, the patient experienced achy and some chills. On night 3, the patient was unresponsive with breathing difficulties. Ejection fraction down to 19 percent and had fluid in lungs. Heart was weak. Intubated and catheter placed. Patient was in cardiac ICU. Responding with hand movements. Would be removed fluid from heart and lungs. The above mentioned events took place after use of product, and required hospitalization. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Body temperature, Chills, Decreased appetite
Clinical narrative: tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen feeling; tongue was swollen and sore feeling in the back of mouth/tongue sensation continued with swollen feeling; difficulty swallowing; sore throat sensation; no appetite; severe abdominal pains; diarrhea; mild heart palpitations; developed fever of 101 Fahrenheit; chills; back pain; Could not Sleep; This is a spontaneous report from a non-contactable consumer reported for herself. A 63-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3247, via an unspecified route of administration on 22Jan2021 09:00 at single dose in left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was in hospital. Medical history included Hashimoto Disease; Moderate Metro Valve Prolapse; known allergies: food Intolerances (Gluten, Eggs, Diary, Soy, Corn). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ciclosporin (RESTASIS), calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D), ascorbic acid (VITAMIN C), ubidecarenone (COQ-10). The patient previously received the first dose of bnt162b2 with lot number: L0140 on 30Dec2020 10:30 AM in left arm for covid-19 immunisation, ciprofloxacin (CIPRO) and experienced drug allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 (Friday Evening) post injection, she could not sleep. On 23Jan2021 (Saturday) severe abdominal pains post breakfast; breakfast was gluten free bread with vegan scrambled eggs and coffee w/ oat milk. Continued diarrhea for about 1 hour; mild heart palpitations, developed fever of 101 Fahrenheit; mild chills and back pain. On 24Jan2021 (Sunday) - still with fever 99.8; no appetite. On 25Jan2021 (Monday) - tongue was swollen and sore feeling in the back of mouth; difficulty swallowing; sore throat sensation; pain of swelling caused it hard anything; remained home from work, did not see medical doctor. From 25Jan2021 to 28Jan2021 tongue sensation continued with swollen feeling, each day getting slightly better by 28Jan2021 (Thursday) feeling normal. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Jan2021. The reporter considered the case as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphagia, Insomnia, Oral pain, Oropharyngeal pain
Clinical narrative: tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen feeling; tongue was swollen and sore feeling in the back of mouth/tongue sensation continued with swollen feeling; difficulty swallowing; sore throat sensation; no appetite; severe abdominal pains; diarrhea; mild heart palpitations; developed fever of 101 Fahrenheit; chills; back pain; Could not Sleep; This is a spontaneous report from a non-contactable consumer reported for herself. A 63-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3247, via an unspecified route of administration on 22Jan2021 09:00 at single dose in left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was in hospital. Medical history included Hashimoto Disease; Moderate Metro Valve Prolapse; known allergies: food Intolerances (Gluten, Eggs, Diary, Soy, Corn). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ciclosporin (RESTASIS), calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D), ascorbic acid (VITAMIN C), ubidecarenone (COQ-10). The patient previously received the first dose of bnt162b2 with lot number: L0140 on 30Dec2020 10:30 AM in left arm for covid-19 immunisation, ciprofloxacin (CIPRO) and experienced drug allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 (Friday Evening) post injection, she could not sleep. On 23Jan2021 (Saturday) severe abdominal pains post breakfast; breakfast was gluten free bread with vegan scrambled eggs and coffee w/ oat milk. Continued diarrhea for about 1 hour; mild heart palpitations, developed fever of 101 Fahrenheit; mild chills and back pain. On 24Jan2021 (Sunday) - still with fever 99.8; no appetite. On 25Jan2021 (Monday) - tongue was swollen and sore feeling in the back of mouth; difficulty swallowing; sore throat sensation; pain of swelling caused it hard anything; remained home from work, did not see medical doctor. From 25Jan2021 to 28Jan2021 tongue sensation continued with swollen feeling, each day getting slightly better by 28Jan2021 (Thursday) feeling normal. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Jan2021. The reporter considered the case as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Swollen tongue
Clinical narrative: tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen feeling; tongue was swollen and sore feeling in the back of mouth/tongue sensation continued with swollen feeling; difficulty swallowing; sore throat sensation; no appetite; severe abdominal pains; diarrhea; mild heart palpitations; developed fever of 101 Fahrenheit; chills; back pain; Could not Sleep; This is a spontaneous report from a non-contactable consumer reported for herself. A 63-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3247, via an unspecified route of administration on 22Jan2021 09:00 at single dose in left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was in hospital. Medical history included Hashimoto Disease; Moderate Metro Valve Prolapse; known allergies: food Intolerances (Gluten, Eggs, Diary, Soy, Corn). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ciclosporin (RESTASIS), calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D), ascorbic acid (VITAMIN C), ubidecarenone (COQ-10). The patient previously received the first dose of bnt162b2 with lot number: L0140 on 30Dec2020 10:30 AM in left arm for covid-19 immunisation, ciprofloxacin (CIPRO) and experienced drug allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 (Friday Evening) post injection, she could not sleep. On 23Jan2021 (Saturday) severe abdominal pains post breakfast; breakfast was gluten free bread with vegan scrambled eggs and coffee w/ oat milk. Continued diarrhea for about 1 hour; mild heart palpitations, developed fever of 101 Fahrenheit; mild chills and back pain. On 24Jan2021 (Sunday) - still with fever 99.8; no appetite. On 25Jan2021 (Monday) - tongue was swollen and sore feeling in the back of mouth; difficulty swallowing; sore throat sensation; pain of swelling caused it hard anything; remained home from work, did not see medical doctor. From 25Jan2021 to 28Jan2021 tongue sensation continued with swollen feeling, each day getting slightly better by 28Jan2021 (Thursday) feeling normal. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Jan2021. The reporter considered the case as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Syncope, Vomiting
Clinical narrative: tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female received the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via intramuscular on 04Feb2021 18:00 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT). On 05Feb2021 5:30, the patient experienced faint and vomit and on 16: 00, more vomit, tired and headache all day. No treatment received for the events. Since the vaccination, the patient has not tested for COVID 19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: shortness of breath; Tested positive; Tested positive; This is a spontaneous report from a contactable consumer. A 69-year-old female patient started to receive BNT162B2 (Pfizer product, lot number was EL3248, expiration date was unknown) via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. Patient was not pregnant. Patient had no COVID prior vaccination. The patient had COVID test post vaccination and tested positive on 26Jan2021. Patient developed shortness of breath oxygen levels keep dropping on 03Feb2021. The events resulted in Emergency room/department or urgent care and hospitalization. It was unknown if patient received treatment for events. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283, expiry date: unknown), via an unspecified route of administration, on 04Feb2021, at single dose, for COVID-19 immunization. Medical history included COVID-19 on Mar2020 (reported as "had the virus"). The patient's concomitant medications were not reported. The patient had a temperature, chills and headache on an unspecified date in Feb2021. The patient thought that it is because she had the virus back in Mar2020. She heard that if you had the virus that the side effects from the vaccine are worse. She wanted to know if that was true. She also wanted to know if she can take Tylenol. She reported that she does not think she will get the second one if it was like this. The outcome of the events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Enlargened lymph node in mouth; headache in temples; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: E13302) solution for injection, via an unspecified route of administration in left arm on 11Jan2021 13:00 at a single dose for Covid-19 immunization. Medical history included lower back pain. Concomitant medications: patient received medications two weeks prior to vaccination. The patient had the first dose of the vaccine on 22Dec2020 at 1pm (lot/batch number: El0140) in left arm. Patient reported that after 2 days (13Jan2021), at around 3pm she got a headache in her temples that would not go away. She went to the urgent care Covid test done which was negative. Had ER visit for headache then with continued headache, then 2 weeks later another ER visit. She also had enlarged lymph node in mouth that was found 2 days ago (03Feb2021). Patient visited ER for the events. As treatment, patient was given Rocephin IV, migraine cocktail, morphine and Dilad. The patient underwent lab tests which included Nasal swab: negative on 16Jan2021 (Rapid test). Prior to vaccination, patient was not diagnosed with Covid-19. Outcome of the events was not recovered.    No follow-up activities are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I broke out with shingles; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number 144414, via an unspecified route of administration in left arm, on 03Feb2021 at 08:45 (at 74 years of age) at single dose for COVID-19 immunization. The patient was not pregnant at the time of the vaccination, she was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Medical history included thyroid disorder from an unknown date. Concomitant medications included thyroid (ARMOUR THYROID), atorvastatin and alendronate sodium. On 05Feb2021 06:00 the patient "broke out with shingles". No treatment was given to the patient for the event. The patient had not recovered yet at the time of the report.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Headache, Laboratory test
Clinical narrative: headache; feeling tired; feeling weak; having breathing problems/couldn't catch my breath; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: 813249 (reported as "Pfizer 813249")), via an unspecified route of administration on 28Jan2021 08:30 at a single dose for covid-19 immunization at a hospital. The patient's medical history was not reported. The patient has no allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received other medications within 2 weeks of vaccination (unspecified). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: ek9231), in the right upper arm on 07Jan2021 for COVID-19 immunization. The following day2 (2021), the patient experienced headache and feeling tired. The 3rd day after, patient was more tired and feeling weak and began having breathing problems. Day 4, more severe breathing problems noted. Day 5, the patient woke up and couldn't catch his breath. The patient went to the ER. The patient had numerous tests and was given breathing treatments, O2, and "Anit bo". The patient was tested for covid post vaccination via nasal swab which was negative. The outcome if the events was recovering.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: headache; feeling tired; feeling weak; having breathing problems/couldn't catch my breath; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: 813249 (reported as "Pfizer 813249")), via an unspecified route of administration on 28Jan2021 08:30 at a single dose for covid-19 immunization at a hospital. The patient's medical history was not reported. The patient has no allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received other medications within 2 weeks of vaccination (unspecified). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: ek9231), in the right upper arm on 07Jan2021 for COVID-19 immunization. The following day2 (2021), the patient experienced headache and feeling tired. The 3rd day after, patient was more tired and feeling weak and began having breathing problems. Day 4, more severe breathing problems noted. Day 5, the patient woke up and couldn't catch his breath. The patient went to the ER. The patient had numerous tests and was given breathing treatments, O2, and "Anit bo". The patient was tested for covid post vaccination via nasal swab which was negative. The outcome if the events was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Pyrexia
Clinical narrative: 101.8 - 102.2 fever; Extreme hip pain, joint pain in knees, elbows majority of day 2; Headache; This is a spontaneous report from a contactable HCP (patient).  This 44-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER4176), via intramuscular on the right arm, on 07Jan2021 (at 13:00) at single dose for COVID-19 immunization, administered at hospital. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via intramuscular on the right arm, on 17Dec2020 at 13:00. No other vaccine was received in four weeks. Relevant medical history included allergy to Brazil nuts and to kiwi. Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (VITAMIN D), chlorella spp., plantago ovata seed husk, spirulina spp. (COLON HEALTH) and glucosamine. On 08Jan2021 (at 10:00), the patient had fever 101.8-102.2 (from 10:00 AM until 4:00 AM following day), extreme hip pain, joint pain in knees, elbows majority of day 2 and headache. The events were assessed as non-serious. The patient was not treated for the events. Post-vaccination COVID-19 test was not done. The patient had recovered from the event in Jan2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Fall, SARS-CoV-2 test
Clinical narrative: death was from natural causes; collapsed; This is a spontaneous report from a contactable consumer.  A 73-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 at 73-years-old at a single dose for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing (on oxygen as needed, but not every day), oxygen therapy from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on unknown dates (Gets flu shot every year around October). On 06Feb2021, the patient collapsed (medically significant) and experienced death was from natural causes (death, medically significant).  The clinical course was reported as follows: The reporter stated that his grandmother received the first dose of the Pfizer COVID-19 vaccine on 05Feb2021 and passed away on the morning of 06Feb2021.  The patient went to bed and woke up in the middle of the night around 03:00 to use the bathroom and collapsed and died within 10-15 minutes of collapsing. The patient was pronounced dead at the scene. The reporter asked: "What do you know about the news in the media about reports of death in nursing home elderly patients?"  The reporter wanted to know the ingredients of the Pfizer COVID-19 vaccine. The reporter wanted to know about the use of the Pfizer COVID-19 vaccine in patients with underlying conditions. The patient had COPD and was on oxygen as needed, but not every day. The Medical examiner said the death was from natural causes and the family was not doing an autopsy.  The patient had been tested for COVID and was negative. The patient underwent lab tests and procedures which COVID test: negative on an unspecified date. The clinical outcome of the event, death was from natural causes, was fatal. The clinical outcome of the event, collapsed, was unknown. The patient died on 06Feb2021 due to death was from natural causes.  An autopsy was not performed.   The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Reported Cause(s) of Death: death was from natural causes
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: left sided facial droop consistent with Bell's palsy; This is a spontaneous report from a contactable Physician. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), intramuscularly on 22Jan2021 at single dose for COVID-19 immunization. Medical history included acral lentiginous melanoma (ALM), myelodysplastic syndrome (MDS), hypertension (HTN), atrial fibrillation, left sided facial and ear pain. The patient's concomitant medications were not reported.  The patient previously took codeine and experienced drug allergy. It was reported that the patient was evaluated in the emergency department on 06Feb2021 for left sided facial droop consistent with Bell's palsy which started from 06Feb2021. The patient was complaining of left sided facial and ear pain for several weeks prior to vaccination and development of Bell's palsy. The reported event Bell's palsy resulted in Emergency room/department or urgent care. Therapeutic measures Valtrex, prednisone were taken as a result of the reported event Bell's palsy. The outcome of the event Bell's palsy was unknown.  Information on Lot/Batch has been requested.; Sender's Comments: Event represents an intercurrent medical condition and unrelated to BNT162B2. The patient experienced  left sided facial and ear pain before receiving vaccination.  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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory distress, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: respiratory distress; covid test result: Positive; This is a spontaneous report from a contactable consumer. An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 19:00 at single dose for covid-19 immunisation. The patient medical history was not reported. No other vaccine in four weeks. There were other medications in two weeks. No COVID prior vaccination. No Known allergies. The patient experienced respiratory distress on 09Jan2021 12:00. Patient was taken to hospital then released week later and currently readmitted with respiratory distress. Treatment received for the events. Nasal Swab Covid test post vaccination on 11Jan2021: result Positive. Outcome of events as not recovered.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Nausea, Paraesthesia
Clinical narrative: fainted; nausea; left arm began to tingle; dizziness; Broke out in a cold sweat; chills; Lost control of my bladder.; This is a spontaneous report from a contactable consumer (patient).  A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL6269), via an unspecified route of administration in Left arm on 04Feb2021 15:00 (at the age of 45-years-old) at SINGLE DOSE for COVID-19 immunization.  Medical history was reported as none.  There were no concomitant medications. 51 hours after receiving the vaccine, the patient was sitting down watching a film. His left arm began to tingle, and he felt a wave of dizziness and nausea come over him. He stood up, walked a few steps and sat back down. He broke out in a cold sweat, chills, and saw stars. He leaned forward with his head in his hands, and apparently fainted for a moment and lost control of his bladder. All events started on 06Feb2021 06:00 PM. No treatment received for the events. The outcome of the events was recovered in Feb2021. No covid prior vaccination, no Covid tested post vaccination, no known allergies.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Urinary incontinence
Clinical narrative: fainted; nausea; left arm began to tingle; dizziness; Broke out in a cold sweat; chills; Lost control of my bladder.; This is a spontaneous report from a contactable consumer (patient).  A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL6269), via an unspecified route of administration in Left arm on 04Feb2021 15:00 (at the age of 45-years-old) at SINGLE DOSE for COVID-19 immunization.  Medical history was reported as none.  There were no concomitant medications. 51 hours after receiving the vaccine, the patient was sitting down watching a film. His left arm began to tingle, and he felt a wave of dizziness and nausea come over him. He stood up, walked a few steps and sat back down. He broke out in a cold sweat, chills, and saw stars. He leaned forward with his head in his hands, and apparently fainted for a moment and lost control of his bladder. All events started on 06Feb2021 06:00 PM. No treatment received for the events. The outcome of the events was recovered in Feb2021. No covid prior vaccination, no Covid tested post vaccination, no known allergies.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fall, Heart rate, Postural orthostatic tachycardia syndrome, Presyncope
Clinical narrative: Nearly passed out; Postural Orthostatic Tachycardia Syndrome; icy like pulsation through my blood occurred; fell to the ground; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (not pregnant) received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), Lot number: EL9261, via an unspecified route of administration on 06Feb2021 12:30 at single dose in Left arm for covid-19 immunisation. Facility type Vaccine was Hospital. Medical history included anaemia, no known allergies. Patient had COVID-19 starting on 06Jan2021 and persisting through 16Jan. Her COVID symptoms were crushing chest pain, no fever, blood oxygen level never dropped below 98%. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. Patient was experiencing Postural Orthostatic Tachycardia Syndrome. Nearly passed out going to the toilet when she first awoke. An icy like pulsation through her blood occurred first thing this AM, day after the vaccine. She fell to the ground and called for her husband to help her. He gave her 500mg acetaminophen and aspirin. She slept. Same thing happened with pulse 140+, he measured, as she showered. They stopped the shower, she laid down and recovered. When she got up immediately the pulse rises to 120+. Adverse events started from 07Feb2021 08:30 AM. Therapeutic measures were taken in response to the events. The outcome of the events was not recovered. Covid was not tested post vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Dizziness, Fall, Headache
Clinical narrative: passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chills-shivers; Bad headache; Dizziness; Couldn't sleep; Neuropathy pain in hip/groin; This is a spontaneous report from a contactable consumer reporting for herself.   A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809 and expiry date unknown) on 05Feb2021 08:30 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included known allergies to statins. The patient had received first dose of BNT162B2 (lot number EL3248) on 15Jan2021 16:00 for COVID-19 immunization (vaccine location=Left arm). The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included gabapentin (GABAPENTIN), fish oil (FISH OIL), zinc (ZINC), cyanocobalamin (VITAMIN B 12), iron (IRON). No other vaccine received in four weeks. The patient experienced adverse events from 05Feb2021 at 20:30. She experienced chills-shivers, had bad head ache, dizziness, couldn't sleep, intense neuropathy pain in hip/groin when got out of bed and then passed out when went into bathroom at 5 am (06Feb2021), cut chin when fell. She felt dehydrated. Cold marble floor felt good as she had sweats, so she just layed there awhile. Her husband came to her rescue with water and cold compress for her head. She received lots of liquids and rest. She had good night's sleep on 06Feb2021. The outcome of the events was reported on 07Feb2021 as recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Loss of consciousness, Neuralgia
Clinical narrative: passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chills-shivers; Bad headache; Dizziness; Couldn't sleep; Neuropathy pain in hip/groin; This is a spontaneous report from a contactable consumer reporting for herself.   A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809 and expiry date unknown) on 05Feb2021 08:30 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included known allergies to statins. The patient had received first dose of BNT162B2 (lot number EL3248) on 15Jan2021 16:00 for COVID-19 immunization (vaccine location=Left arm). The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included gabapentin (GABAPENTIN), fish oil (FISH OIL), zinc (ZINC), cyanocobalamin (VITAMIN B 12), iron (IRON). No other vaccine received in four weeks. The patient experienced adverse events from 05Feb2021 at 20:30. She experienced chills-shivers, had bad head ache, dizziness, couldn't sleep, intense neuropathy pain in hip/groin when got out of bed and then passed out when went into bathroom at 5 am (06Feb2021), cut chin when fell. She felt dehydrated. Cold marble floor felt good as she had sweats, so she just layed there awhile. Her husband came to her rescue with water and cold compress for her head. She received lots of liquids and rest. She had good night's sleep on 06Feb2021. The outcome of the events was reported on 07Feb2021 as recovered.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Moderate diarrhea with dark red blood in stool on day 3; Moderate diarrhea with dark red blood in stool on day 3; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Left arm on 04Feb2021 08:30 (at the age of 73-years-old) at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient experienced moderate diarrhea with dark red blood in stool on day 3 on 07Feb2021 08:00. No treatment received for the events. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Electrocardiogram, Pain in extremity
Clinical narrative: Chest pain; shortness of breath; pain radiating down left arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 06Feb2021 12:00 at single dose in left arm for COVID-19 immunisation. Medical history included allergies to iodinated contrast, chronic lymphocytic leukaemia (CLL), herniated discs. The patient didn't have COVID prior vaccination. Concomitant medications included tamsulosin hydrochloride (FLOMAX), sertraline hydrochloride (ZOLOFT), valacyclovir, ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER). The patient previously received the first dose of bnt162b2 on 16Jan2021 02:00 PM in left arm for COVID-19 immunisation. There were no other vaccine in four weeks. The patient experienced chest pain, shortness of breath, pain radiating down left arm. Adverse events start from 07Feb2021 05:45 AM. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and hospitalization for 1 day. Treatment was received for the events. The patient underwent lab test which included Blood tests, EKG on unknown date. The outcome of the events was recovering. COVID was not tested post vaccination.  Information on Lot/Batch has been requested.