chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0167), via an unspecified route of administration, administered in left arm on 30Apr2021 15:00 as 1st dose, single for COVID-19 immunization. Medical history included amoxicillin allergy. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient experienced difficulty breathing, feverish on 01May2021 23:00. The events resulted in emergency room/department or urgent care visit. The patient was hospitalized due to the events. Therapeutic measures were taken as a result of the events and included treatment with prednisone 20 mg for 5 days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Seriousness of the events was reported as non-serious. Information on lot/batch number was available. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: terrible muscle/joint pain; terrible muscle/joint pain; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: 9266), via an unspecified route of administration, administered in the left arm on 14Feb2021 at 10:00 as a single dose for COVID-19 immunization. Medical history included ongoing lung cancer and known allergy to lobster and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 25Jan2021 on the left arm for COVID-19 immunization. On 16Feb2021 at 03:00 the patient had terrible muscle/joint pain since the second dose of the vaccine. It gets worse everyday. The event caused a doctor or other healthcare professional office/clinic visit. The patient has not recovered from the events. The events were reported with a seriousness of disability.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pyrexia, Syncope
Clinical narrative: fainted; low blood pressure; fever; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 01May2021 (Batch/Lot Number: Unknown) as 2nd dose, single dose (at the age of 28-years-old) for COVID-19 immunization. Medical history was not reported. The patient did not have concomitant medications: the patient did not have any other medications the patient received within 2 weeks of vaccination. The patient received the first dose of 12Apr2021 BNT162B2 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks. On 02May2021, around 24 hours after receiving the second shot of COVID vaccine the patient fainted due to fever and low blood pressure. The patient required emergency room/department or urgent care. The patient did not receive treatment for the events. The patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Inappropriate schedule of product administration, Off label use
Clinical narrative: Diarrhea; first dose on 17Feb2021/second dose on 03Mar2021; first dose on 17Feb2021/second dose on 03Mar2021; This is a spontaneous report from a contactable consumer (patient). A 69-year-old patient of unspecified gender received 2 nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration at right arm at the age of 69 years old on 03Mar2021 as single dose for COVID-19 immunization. The patient medical history included headache. Concomitant medications included ibuprofen taken for headache, start date reported as'20 years, 30 years before, not confirmed, actually 40 year before when Ibuprofen 1st came out' and Multivitamins took it regularly one tablet per day from many years, all life (as reported). The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 (at 69 years old) in right forearm near the shoulder for covid-19 immunization with no adverse event. The patient experienced a little small amount of diarrhea on 04Mar2021 on the following day of the 2nd dose but otherwise was pretty good. No investigation assessment. No treatment received. Diarrhea was gone in couple of days. The outcome of the event diarrhea was recovered on unknown date in 2021.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 21-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170, expiration date not provided), 1st dose via an unspecified route of administration, administered in arm left on 26Apr2021 11:30 at age of 21 years old as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on 26Apr2021. The patient underwent lab tests and procedures which included test for COVID-19: negative (nasal swab) on 26Apr2021. The outcome of the event was resolving. The report was reported as non-serious. The event had not being prolonged hospitalization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are needed.  No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, VIth nerve paralysis
Clinical narrative: abducens nerve palsy right eye and fever; fever; This is a spontaneous report from a non-contactable healthcare professional. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was not pregnant. The patient experienced abducens nerve palsy right eye and fever on 18Apr2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event abducens nerve palsy right eye cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Haemorrhage, Hypoacusis, Peripheral swelling
Clinical narrative: Have some kind of bleeding issue I am on warfarin; Hard of hearing; leg started swelling a week; Eye pain, they hurt; Low grade fever with a 100; chills; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 (Batch/Lot Number: EW0161) as 2nd dose, single for COVID-19 immunization; warfarin, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at an unknown dose for bleeding issue. Concomitant medication included simvastatin; and furosemide (LASIX) taken for an unspecified indication from 26Apr2021 to an unspecified stop date. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose on 25Mar2021 (lot number: EN6199) for COVID-19 immunization and experienced leg swelling and hard of hearing. The patient mentioned she was hard of hearing. The patient had a reaction to both of the Pfizer shots. Her second one was on the 26Apr2021, her first one was on 25Mar2021. Her leg started swelling a week after and on 26Apr2021, she had her second and the same evening she started having eye pain, it's just they hurt, there was no redness, no swelling, no visual problems, they just hurt and they still hurt. And that night, she had low grade fever with a 100, chills and that lasted about, the fever and chills lasted about 10 hours but the eye pain was still there, it's just eye pain, no vision changes, no redness nothing it's just eye pain. She mentioned she was not tired or stressed, it was just there. The patient also reported that she had some kind of bleeding issue and she was on warfarin. The outcome of the event eye pain was not recovered, fever and chills was recovered while other events was unknown. The event bleeding issue was assessed as serious- medically significant.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Have some kind of bleeding issue I am on warfarin; Hard of hearing; leg started swelling a week; Eye pain, they hurt; Low grade fever with a 100; chills; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 (Batch/Lot Number: EW0161) as 2nd dose, single for COVID-19 immunization; warfarin, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at an unknown dose for bleeding issue. Concomitant medication included simvastatin; and furosemide (LASIX) taken for an unspecified indication from 26Apr2021 to an unspecified stop date. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose on 25Mar2021 (lot number: EN6199) for COVID-19 immunization and experienced leg swelling and hard of hearing. The patient mentioned she was hard of hearing. The patient had a reaction to both of the Pfizer shots. Her second one was on the 26Apr2021, her first one was on 25Mar2021. Her leg started swelling a week after and on 26Apr2021, she had her second and the same evening she started having eye pain, it's just they hurt, there was no redness, no swelling, no visual problems, they just hurt and they still hurt. And that night, she had low grade fever with a 100, chills and that lasted about, the fever and chills lasted about 10 hours but the eye pain was still there, it's just eye pain, no vision changes, no redness nothing it's just eye pain. She mentioned she was not tired or stressed, it was just there. The patient also reported that she had some kind of bleeding issue and she was on warfarin. The outcome of the event eye pain was not recovered, fever and chills was recovered while other events was unknown. The event bleeding issue was assessed as serious- medically significant.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mouth swelling, Myalgia, Oropharyngeal pain, Pain in extremity
Clinical narrative: Arm was very sore; Muscle ache throughout my body; Headache; Sore throat; Swelling mouth; ulcer on tongue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 09:30 (at 39 years old, not pregnant) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient used nickel on an unspecified date. First dose received Saturday 24Apr2021 on left arm, next day (all events also reported started 28Apr2021) arm was very sore and muscle ache throughout my body and headache. Couple days later sore throat and swelling mouth and ulcer on tongue. Adverse events result in Emergency room/department or urgent care. Treatment received for the adverse event wasUrgent care and Rx. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, nasal swab on 29Apr2021, negative results, nasal swab on 01May2021, unknown results. The outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Tongue ulceration
Clinical narrative: Arm was very sore; Muscle ache throughout my body; Headache; Sore throat; Swelling mouth; ulcer on tongue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 09:30 (at 39 years old, not pregnant) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient used nickel on an unspecified date. First dose received Saturday 24Apr2021 on left arm, next day (all events also reported started 28Apr2021) arm was very sore and muscle ache throughout my body and headache. Couple days later sore throat and swelling mouth and ulcer on tongue. Adverse events result in Emergency room/department or urgent care. Treatment received for the adverse event wasUrgent care and Rx. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, nasal swab on 29Apr2021, negative results, nasal swab on 01May2021, unknown results. The outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Limb injury
Clinical narrative: His arm hurt; A little tired; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had zero issues, his arm hurt. The patient was fine, nothing happened to him, he had nothing, he was a little tired and his arm hurt. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Had 2 episodes of syncope; Shortness of breath; weakness; Fatigue; 80% O2 saturation on RA; Heart rate up to 180; Rash on his abdomen appeared; This is a spontaneous report received from a non-contactable pharmacist. A 39-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscularly administered in left arm on 29Apr2021 08:45 (Batch/Lot Number: EW0172) (age at vaccination: 39 years old) as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. On an unspecified date, prior to vaccination, the patient was diagnosed with COVID-19, unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. He had previously received the first dose of BNT162b2 on 08Apr2021 08:00 (Batch/lot number: EWP0158) (age at vaccination: 39 years old) as single dose for COVID-19 immunisation. Concomitant medication(s) included albuterol (ALBUTEROL) inhaler, naproxen (NAPROXEN) and calcium carbonate (CALCIUM CARBONATE), taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021, the patient developed shortness of breath, weakness, fatigue hours after administration of the vaccine. He had 2 episodes of syncope, 80% O2 saturation on room air (RA), heart rate up to 180. Rash on his abdomen appeared. The adverse events resulted in emergency room/department or urgent care. The patient was admitted to the hospital on an unspecified date in Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported events and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, Rash, Syncope
Clinical narrative: Had 2 episodes of syncope; Shortness of breath; weakness; Fatigue; 80% O2 saturation on RA; Heart rate up to 180; Rash on his abdomen appeared; This is a spontaneous report received from a non-contactable pharmacist. A 39-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscularly administered in left arm on 29Apr2021 08:45 (Batch/Lot Number: EW0172) (age at vaccination: 39 years old) as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. On an unspecified date, prior to vaccination, the patient was diagnosed with COVID-19, unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. He had previously received the first dose of BNT162b2 on 08Apr2021 08:00 (Batch/lot number: EWP0158) (age at vaccination: 39 years old) as single dose for COVID-19 immunisation. Concomitant medication(s) included albuterol (ALBUTEROL) inhaler, naproxen (NAPROXEN) and calcium carbonate (CALCIUM CARBONATE), taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021, the patient developed shortness of breath, weakness, fatigue hours after administration of the vaccine. He had 2 episodes of syncope, 80% O2 saturation on room air (RA), heart rate up to 180. Rash on his abdomen appeared. The adverse events resulted in emergency room/department or urgent care. The patient was admitted to the hospital on an unspecified date in Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported events and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Nausea, Seizure like phenomena
Clinical narrative: seizure like movements; passed out; dizzy; nausea; This is a spontaneous report from a non-contactable healthcare professional (HCP). A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE)  via an unspecified route of administration on an unspecified date (age at vaccination: 19 years old) (Batch/Lot Number: ew0167) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient experienced dizzy, nausea, passed out, seizure like movements on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Body temperature, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Bell's palsy; After second shot, 102 fever for 76 hours; vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number: unknown) via an unspecified route of administration on 12Mar2021 (36-year-old at vaccination) at a single dose for COVID-19 immunisation. Medical history was reported as the patient did not test positive for COVID, but did have a respiratory illness preceding the bell's palsy. Known allergies: sulfa and tetracycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination was reported as none. The patient was not pregnant at time of vaccination. The patient experienced adverse events after second shot, was reported as 102 fever for 76 hours, vomiting and diarrhea; all with onset date in 2021. On 30Apr2021, the patient was diagnosed with bell's palsy in emergency room. She was not sure that they were related, just reporting for your tracking purposes. The adverse event result in emergency room/department or urgent care. Treatment received for the adverse event included steroids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not resolved.  Follow-up attempts are needed. Further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Embolism, Rash
Clinical narrative: Blood clot; Random bruise on knuckle; Joint pain; Rash; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 14Apr2021 at 04:00 PM at age of 57-year-old at single dose, unknown dose number for COVID-19 immunization. Patient was not pregnant at time of vaccination and at time of events onset. Medical history included known allergies (unspecified). Compound heft (pending clarification) was reported as other medical history. Prior to vaccination, it was unknown if patient was diagnosed with COVID-19. Since the vaccination, the patient wasn't tested for COVID-19. Concomitant medications included supplements in two weeks. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had rash on day 10 on 24Apr2021 at 03:00 PM, joint pain on day 11 (25Apr2021), day 12 (26Apr2021), day 13 (27Apr2021) and a blood clot and random bruise on knuckle on day 14 (28Apr2021). Events didn't result in emergency room visit or physician office visit. No treatment received for the events. Outcome of events was recovering.  Information about Lot/Batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia
Clinical narrative: Bells Palsy; Facial numbness and drooping left side. Eye, cheek, lips.; This is a spontaneous report from a contactable nurse. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Jan2021 15:00 (Batch/Lot Number: EK4176) as 2nd dose, single for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 15:30 in the left arm (lot number: EH9899). The patient did not receive any other vaccines within 4 weeks prior the COVID vaccine. The patient experienced Facial numbness and drooping left side. Eye, cheek, lips; had Bells Palsy on 30Apr2021 11:00 which resulted a visit in the emergency room or urgent care. Steroids and acyclovir were taken as treatment for the events. The patient was not diagnosed with COVID prior vaccination and has not been tested after vaccination. The outcome of the event was unknown. The event Bells Palsy was assessed as serious- medically significant.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious event cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. 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 the Authorities, Ethics Committees and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Ear haemorrhage, Otorrhoea
Clinical narrative: Bleeding in right ear; ear does not necessarily hurt but I feel moisture in it and when I tried to clean the ear with several stops; This is a spontaneous report from a contactable consumer.   A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 27Apr2021 14:30 (Batch/Lot number was not reported) as unknown, single (at the age of 32 years old) for COVID-19 immunisation.  Medical history included depression and anxiety.  The patient stated on 28Apr2021, "bleeding in right ear. I've never had an issue with my ears, I'm a healthy 32 year old woman. My ear does not necessarily hurt but I feel moisture in it and when I tried to clean the ear with several stops, blood is on each stop. It's been 5 days and my ear is still bleeding with unknown cause". Prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient received no treatment. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain/same problem; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporting consumer had been rushed to the hospital last night (30Apr2021 at around 11:00PM) because she thought she was having a heart attack; she had really bad chest pain. She reported another guy (patient) at the hospital had the same problem as her. The guy said he was healthy and had just gotten the COVID-19 Vaccine. The patient experienced chest pain on an unspecified date in Apr2021. The clinical outcome was not reported.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021490608 same reporter/ drug, different patient, similar & different events
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Hypoacusis, Lip discolouration
Clinical narrative: seizure; faint; feeling dizzy; drained again; his lips lost their color; difficulty hearing; nauseous; sweating profusely; This is a spontaneous report from a contactable pharmacist. An adolescent male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: Er8736), intramuscular, administered in Arm Left on 30Apr2021 20:30 as 1st dose, single for COVID-19 immunization. Medical history, none known. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient reported no previous adverse events with prior vaccinations, specifically dizziness or fainting. After the shot he went to the bathroom, returned fairly quickly & reported feeling dizzy and quickly took a seat and thought he might faint. Soon thereafter he seemed to have a seizure. His eyes remained open but rolled back, he stayed upright but was unresponsive.  They removed his mask & his mother & they kept talking to him. It ended after about 10 seconds & he asked how long he had been out. His color was momentarily better, but drained again & his lips lost their color. They asked if he had any difficulty breathing and he did not. He reported that he had difficulty hearing (like he had headphones on) & was sweating profusely.  His mother kept encouraging him to take deep breaths, they got him some water & asked if he had a history of hypoglycemia- he did not. They asked if they could get him a candy bar& they asked for a granola bar which they acquired.  He was too nauseous to eat it & asked. The events started on 30Apr2021 20:30. No treatment was given. The outcome of the events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure and the other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EEG and head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Seizure, Syncope
Clinical narrative: seizure; faint; feeling dizzy; drained again; his lips lost their color; difficulty hearing; nauseous; sweating profusely; This is a spontaneous report from a contactable pharmacist. An adolescent male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: Er8736), intramuscular, administered in Arm Left on 30Apr2021 20:30 as 1st dose, single for COVID-19 immunization. Medical history, none known. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient reported no previous adverse events with prior vaccinations, specifically dizziness or fainting. After the shot he went to the bathroom, returned fairly quickly & reported feeling dizzy and quickly took a seat and thought he might faint. Soon thereafter he seemed to have a seizure. His eyes remained open but rolled back, he stayed upright but was unresponsive.  They removed his mask & his mother & they kept talking to him. It ended after about 10 seconds & he asked how long he had been out. His color was momentarily better, but drained again & his lips lost their color. They asked if he had any difficulty breathing and he did not. He reported that he had difficulty hearing (like he had headphones on) & was sweating profusely.  His mother kept encouraging him to take deep breaths, they got him some water & asked if he had a history of hypoglycemia- he did not. They asked if they could get him a candy bar& they asked for a granola bar which they acquired.  He was too nauseous to eat it & asked. The events started on 30Apr2021 20:30. No treatment was given. The outcome of the events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure and the other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EEG and head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Presyncope, SARS-CoV-2 test negative, Scan, Seizure
Clinical narrative: pre-syncopal and syncopal episodes; pre-syncopal and syncopal episodes; seizure; This is a spontaneous report from a contactable consumer.   A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 14Apr2021, at 10:00 (Batch/Lot Number: ER8731) as single dose for covid-19 immunization.  Medical history included hypertension, breast cancer, penicillin allergy, allergy to sulfa, and osteoporosis from unspecified dates. Concomitant medications included metoprolol tartrate (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; losartan (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; folic acid (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; exemestane (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported.  The patient experienced pre-syncopal and syncopal episodes and seizure on 23Apr2021, which  were serious as they involved hospitalization.  The patient was hospitalized for 2 days for the events.  The patient underwent lab tests and procedures which included blood test: negative on 22Apr2021, Covid-19 test: negative on an unspecified date, since the vaccination,  scan: no lesions on an unspecified date. Details were as follows: a week and a half after the vaccine, patient started having pre-syncopal and syncopal episodes, increasing in frequency.  After two days, patient went to the emergency room, where she had a seizure and was admitted to the hospital. Scans showed no lesions. Patient was put on Keppra, and no more seizures. Therapeutic measures were taken as a result of the events; treatment received for the adverse events included benzodiazepine, Keppra, and intravenous  fluids.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: pre-syncopal and syncopal episodes; pre-syncopal and syncopal episodes; seizure; This is a spontaneous report from a contactable consumer.   A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 14Apr2021, at 10:00 (Batch/Lot Number: ER8731) as single dose for covid-19 immunization.  Medical history included hypertension, breast cancer, penicillin allergy, allergy to sulfa, and osteoporosis from unspecified dates. Concomitant medications included metoprolol tartrate (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; losartan (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; folic acid (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; exemestane (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported.  The patient experienced pre-syncopal and syncopal episodes and seizure on 23Apr2021, which  were serious as they involved hospitalization.  The patient was hospitalized for 2 days for the events.  The patient underwent lab tests and procedures which included blood test: negative on 22Apr2021, Covid-19 test: negative on an unspecified date, since the vaccination,  scan: no lesions on an unspecified date. Details were as follows: a week and a half after the vaccine, patient started having pre-syncopal and syncopal episodes, increasing in frequency.  After two days, patient went to the emergency room, where she had a seizure and was admitted to the hospital. Scans showed no lesions. Patient was put on Keppra, and no more seizures. Therapeutic measures were taken as a result of the events; treatment received for the adverse events included benzodiazepine, Keppra, and intravenous  fluids.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral artery thrombosis
Clinical narrative: Left distal artery thrombus 2 days after receiving covid vaccination in left arm; This is a spontaneous report from a contactable physician. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the left arm on 23Feb2021 (batch/lot number and expiration date were unknown) as an unknown dose number, single for COVID-19 immunization. Relevant medical history included chronic kidney disease (CKD), vitamin (vit) b12 deficiency, vit d deficiency, and hypertension (htn); all from an unknown date and unknown if ongoing. The patient received other unspecified medications for hormone replacement therapy within 2 weeks of vaccination. The patient previously took tramadol and gentamicin, from which the patient experienced known allergies. The facility where the most recent COVID-19 vaccine was administered was unknown. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Feb2021, the patient experienced left distal artery thrombus 2 days after receiving COVID vaccination in left arm. The adverse event (AE) resulted in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care, as well as hospitalization for 6 days. Therapeutic measures were taken as a result of left distal artery thrombus 2 days after receiving COVID vaccination in left arm, which included embolectomy and anticoagulation. The patient recovered from the event on an unspecified date.  Information on the batch/lot number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event peripheral artery thrombosis 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest scan, Pain, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: pulmonary embolism; body pain; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2) unknown dose number, via an unspecified route of administration, administered in left arm on 27Mar2021 13:15 (Batch/Lot number was not reported) (at age 71 years old) as single dose for covid-19 immunisation in a hospital. Medical history included hypertension, asthma, osteoporosis and hypothyroidism, all from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. No covid prior to vaccination. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. No other vaccine administered in four weeks. The patient previously received tetanus vaccine on an unspecified date for immunization and experienced allergies. On 28Mar2021, the patient had generalized body pain for 3 days. On the fourth day (30Mar2021), pain in her right rib area. Pain progressed for various days until she could not breathe. She went to emergency room twice and was diagnosed with pulmonary embolism on 04Oct2021 (as reported) confirmed with a CT chest scan. The events resulted in emergency or urgency room/department and hospitalization. The patient was hospitalized for three days. Treatment for the events included anticoagulant therapy. The patient underwent covid test (nasa swab) on 08Apr2021 with negative result. The patient was recovering from the events.  Information on the lot/ batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cerebrovascular accident, Headache, Hypertension, Paraesthesia
Clinical narrative: Got diagnosed with mild stroke after a high blood pressure crisis; Got diagnosed with mild stroke after a high blood pressure crisis; blurry vision on the left eye; Pins and needles feelings in left body side; headache; memory loss; This is a spontaneous report from a contactable consumer (reporting for herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 13Mar2021 at 10:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included high blood pressure, and asthma. The patient's concomitant medications were not reported. On 14Mar2021, the patient was diagnosed with mild stroke after a high blood pressure crisis and the symptoms showed days after the vaccine such as blurry vision on the left eye, pins and needles feeling in left body side, headache and memory loss. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of the events was unknown. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in emergency room/department or urgent care and was admitted in the hospital for 2 day. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vision blurred
Clinical narrative: Got diagnosed with mild stroke after a high blood pressure crisis; Got diagnosed with mild stroke after a high blood pressure crisis; blurry vision on the left eye; Pins and needles feelings in left body side; headache; memory loss; This is a spontaneous report from a contactable consumer (reporting for herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 13Mar2021 at 10:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included high blood pressure, and asthma. The patient's concomitant medications were not reported. On 14Mar2021, the patient was diagnosed with mild stroke after a high blood pressure crisis and the symptoms showed days after the vaccine such as blurry vision on the left eye, pins and needles feeling in left body side, headache and memory loss. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of the events was unknown. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in emergency room/department or urgent care and was admitted in the hospital for 2 day. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I did have Covid in between vaccine 1 and vaccine 2; I did have Covid in between vaccine 1 and vaccine 2.; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in right arm on 16Mar2021 11:00 (Batch/Lot number was not reported) as single, dose 2 via an unspecified route of administration, administered in right arm on 06Apr2021 11:00 (Batch/Lot number was not reported) as single for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did have COVID in between vaccine 1 and vaccine 2 on an unspecified date with outcome of unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.