chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Sleep disorder
Clinical narrative: wakes up in the middle of the night having chills, fever and bad headache; wakes up in the middle of the night having chills, fever and bad headache; wakes up in the middle of the night having chills, fever and bad headache; wakes up in the middle of the night having chills, fever and bad headache; This is a spontaneous report from a Pfizer sponsored program. A contactable other hcp 67-year-old male Nurse (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on Jun2021 (age at the time of vaccination 67-year-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date Jun2021, the patient experienced wakes up in the middle of the night having chills, fever and bad headache. Patient stated, the events had for 2 days. The patient took Tylenol to reduce fever. The outcome for all the events was recovered on an unspecified date 2021.  Information about lot/batch number requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, C-reactive protein increased, Chest discomfort, Chest pain, Myocarditis
Clinical narrative: Atrial fibrillation; pericarditis; low grade myocarditis; he was still having chest discomfort.; pleuritic chest pain; This is a spontaneous report from a contactable physician. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: not reported), via an unspecified route of administration on 12Jan2021 (at the age of 79-years-old) as dose 1, single, and via an unspecified route of administration on 02Feb2021 as dose 2, single for covid-19 immunization. Medical history included ongoing hyperlipidemia; ongoing Presume erectile dysfunction. Concomitant medications included rosuvastatin (ROSUVASTATIN) taken for hyperlipidemia; tadalafil (CIALIS) taken for erectile dysfunction. On 03Jun2021 the patient experienced atrial fibrillation. On Jun2021 the patient experienced pericarditis, low grade myocarditis. on 02Jun2021 the patient experienced pleuritic chest pain, on 10Jun2021 the patient experienced he was still having chest discomfort. The patient underwent lab tests and procedures which included C-reactive protein increased: 65.2 on 03Jun2021 upper limit of normal is less than 8 , C-reactive protein increased: 74 on 10Jun2021, C-reactive protein increased: 65.1 on 16Jun2021, sedimentation rate: 80 on an unspecified date, sedimentation rate: 25 on 10Jun2021, sedimentation rate: extremely high on 24Jun2021, troponin: elevated on 03Jun2021, troponin: normal on 10Jun2021 .Therapeutic measures were taken as a result of atrial fibrillation, pericarditis, low grade myocarditis , pleuritic chest pain, he was still having chest discomfort. Treatment included on 24Jun2021 primary/internist started patient on steroids which caller clarified as being Prednisone 20mg because he was not feeling well and a sedimentation rate came back quote: extremely high; Eliquis 5mg twice daily with the atrial fibrillation; When caller first met the patient, he started Motrin and Colchicine-which caller clarified as they gave him Mitigare which caller believes is the same thing as Colchicine: 0.6 twice daily. The outcome of events was not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information currently available, the causal association between the event Pericarditis, myocarditis and the suspect drug cannot be excluded. Also, there is limited information in the case provided, the causal association between the event Atrial fibrilation, Chest pain, Chest discomfort and the suspect drug 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 RAs, Ethics Committees, and investigators, as appropriate.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Red blood cell sedimentation rate, Troponin
Clinical narrative: Atrial fibrillation; pericarditis; low grade myocarditis; he was still having chest discomfort.; pleuritic chest pain; This is a spontaneous report from a contactable physician. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: not reported), via an unspecified route of administration on 12Jan2021 (at the age of 79-years-old) as dose 1, single, and via an unspecified route of administration on 02Feb2021 as dose 2, single for covid-19 immunization. Medical history included ongoing hyperlipidemia; ongoing Presume erectile dysfunction. Concomitant medications included rosuvastatin (ROSUVASTATIN) taken for hyperlipidemia; tadalafil (CIALIS) taken for erectile dysfunction. On 03Jun2021 the patient experienced atrial fibrillation. On Jun2021 the patient experienced pericarditis, low grade myocarditis. on 02Jun2021 the patient experienced pleuritic chest pain, on 10Jun2021 the patient experienced he was still having chest discomfort. The patient underwent lab tests and procedures which included C-reactive protein increased: 65.2 on 03Jun2021 upper limit of normal is less than 8 , C-reactive protein increased: 74 on 10Jun2021, C-reactive protein increased: 65.1 on 16Jun2021, sedimentation rate: 80 on an unspecified date, sedimentation rate: 25 on 10Jun2021, sedimentation rate: extremely high on 24Jun2021, troponin: elevated on 03Jun2021, troponin: normal on 10Jun2021 .Therapeutic measures were taken as a result of atrial fibrillation, pericarditis, low grade myocarditis , pleuritic chest pain, he was still having chest discomfort. Treatment included on 24Jun2021 primary/internist started patient on steroids which caller clarified as being Prednisone 20mg because he was not feeling well and a sedimentation rate came back quote: extremely high; Eliquis 5mg twice daily with the atrial fibrillation; When caller first met the patient, he started Motrin and Colchicine-which caller clarified as they gave him Mitigare which caller believes is the same thing as Colchicine: 0.6 twice daily. The outcome of events was not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information currently available, the causal association between the event Pericarditis, myocarditis and the suspect drug cannot be excluded. Also, there is limited information in the case provided, the causal association between the event Atrial fibrilation, Chest pain, Chest discomfort and the suspect drug 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 RAs, Ethics Committees, and investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Patient did miss taking some of the time medication when was sick post COVID vaccine; This is a spontaneous report form a contactable other HCP and contactable consumer. A 49-year-old female patient received both doses (first and second dose) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunization and co-suspect ongoing tofacitinib citrate (Xeljanz XR, prolonged-release tablet) 11 mg daily via orally from on an unknown date in Jan2021, taken for rheumatoid arthritis. The patient's medical history included ongoing rheumatoid arthritis. Concomitant medications were not reported. Patient took both COVID vaccine doses, and was off Xeljanz for maybe two weeks per MD recommendation. Patient did miss taking some of the time medication when was sick, post COVID vaccine. One time run out Xeljanz for almost a week-issues with delivery. No symptoms reported with missed doses. The benefits of medication outweigh the risk- it did help patient. Denies feeling sad/ discouraged had learn to live with it- before was feeling discouraged. Outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Pain, Pyrexia
Clinical narrative: Whole entire body is aching; Flu-like symptoms; Fever; He feels really, really sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Jun2021 (age at the time of vaccination was 56-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient did not receive any other products. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On 30Jun2021 (in the middle of the night on the day of vaccination), the patient experienced whole entire body was aching, had flu-like symptoms and fever. The patient felt really, really sick. The patient asked that she need help and what should the patient take. The caller confirmed details provided by transfer agent. The caller stated that the patient had to skipped work two days now. The caller stated that the patient was not going to answer questions. The patient was not going to give all this information about the experience and not get help. The patient felt like this was unsafe. There are people that have been experiencing this. The needed help. Received communication reported that the caller informed that for medical treatment or advice the patient would have to reach out to his doctor or if the patient was having an emergency that the patient would need to call or go to the emergency room. Caller then abruptly disconnected the call. Full details unable to be obtained. The outcome of the events was unknown.  Information about lot/batch number is requested.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic, Scratch
Clinical narrative: He developed an itchy rash after the 2nd dose; Still have the rash and itching; Still have the rash and itching/ waking up scratching all the time; Still have the rash and itching/ waking up scratching all the time; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 84-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318 and expiration date was not reported), second dose via an unspecified route of administration on 03Feb2021 (at the age of 84 years) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration on 14Jan2021 as single for covid-19 immunisation. On unspecified date of 2021 after the 2nd dose patient developed an itchy rash. Patient had been seen by his HCP and they gave given him 2 doses of Prednisone, hydroxide for itching, as well as Zyrtec. Patient states that "none of it helps. Still have the rash and itching. Not as bad but still there and waking up scratching all the time." Patient is "wondering if there is someone at Pfizer that can indicate what he can be taking that may help the rash." patient states the problem is he is not sure the doctors know what to do with the vaccine being so new. patient states he is not sure going back and forth to the doctor is going to help and questions if the health department would possibly know more. The adverse events involved visit to physician office. The outcome of the event still have the rash and itching/ waking up scratching all the time was unknown, while the rest of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Pruritus, Rash, Skin disorder
Clinical narrative: left eye continues to water; she started breaking out on neck and face; itching really bad; My skin looks bad it doesn't normally look like this. It's only on my neck and face.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: EW0217, Expiration date: 30Sep2021), via an unspecified route in the left arm on 23Jun2021 (Wednesday) between 11:30 to 12:00 (at the age of 62-year-old), as a single dose for COVID-19 immunization at pharmacy. The patient medical history and concomitant medications were not reported. Family medical history was reported as none. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EW0178, Expiration date: 31Aug2021), via an unspecified route in the left arm on 02Jun2021 (at the age of 62-year-old), as single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 28Jun2021 (Monday) afternoon, probably around 16:00, patient started breaking out on neck and face, itching really bad. She wants to know if this is a side effect due to length of time. It was within an hour of the shot but 5 days after. Is that normal or anyone else reported this before? Her left eye continues to water and that started last night (01Jul2021). She has not done anything different. Her skin looks bad it doesn't normally look like this. It's only on her neck and face. It's not on anywhere else. Reading on the pamphlet, which states it should happen within an hour after at the shot, but it didn't happen until Monday almost a week later. She wants to know if this is a side effect due to length of time. It was within an hour of the shot but 5 days after. She wants to know is that normal or anyone else reported this before? Adverse events did not result in emergency room or Physician office visit. Relevant tests were reported as none. Therapeutic measures taken as a result of the events included, she put calamine lotion on it and done all she knows to do. The clinical outcome of breaking out on neck and face, itching really bad was ongoing and persisting, outcome of left eye continues to water was unknown and outcome of skin looks bad it doesn't normally look like this was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested postive for covid sometime after that; tested postive for covid sometime after that; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Mar2021 as a single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced tested positive for covid sometime after the first covid vaccination. He had to wait 90 days before the second vaccine which has been scheduled for tomorrow 03Jul.  He wanted to confirm that he still has an appointment. He thought it was unusual that it was on a Saturday. The outcome of event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I had some medical condition but I after taking Pfizer vaccine in March and April, my all medical conditions seems going away; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 2, single, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient reported that "I had some medical condition but I after taking Pfizer vaccine in Mar and Apr, my all medical conditions seems going away. This is something positive effect happen after taking Pfizer vaccine. I am just writing this message in case someone can benefit of it". The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a patient of unspecified age and gender received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced dizzy. The patient inquired about the vaccine information including manufacturing and Authorization product information. The patient participated in the Pfizer-BioNTech COVID-19 clinical trial and inquired about if patient could receive placebo. The outcome of the event dizzy was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (patient's husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: unknown; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient experienced contracted COVID-19 on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2 test positive on an unspecified date. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Fatigue, Feeling hot
Clinical narrative: having some side effects such as diarrhea; feeling really tired and I fall asleep; I am feeling weak; feeling a little hot; Dizzy; This is a spontaneous report from contactable consumer (Patient). A 46-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, and Lot number: EW0187) via unspecified route of administration, administered in left arm on 01Jul2021 10:10 (at age of 46-year-old) as dose 2, single for COVID-19 Immunization. Patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were none. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0173) via unspecified route of administration in left arm on 10Jun2021 (at age of 46-years), as Dose 1 single, for COVID-19 Immunization. On 01Jul2021, the patient stated that she received the second dose yesterday and she had been having diarrhea ever since, it had not stopped and she was feeling weak, it seems like anything that she eats or drink it just did not stay in her stomach and she asked that what should she do and how long was this going to last. On the same day, the caller stated that she was feeling dizzy and weak; she was feeling really tired, and she fell asleep, and when she woke up, she was feeling a little hot, but she washed her face to cool off and she was okay. She was asking for recommendations on what she should do about the side effects she was experiencing. The caller was still experiencing events and was enquired about how long this was going to last. Patient did not receive treatment for events. The outcome of event feeling hot was considered as resolved, on an unspecified date in Jul2021, while the outcome of the rest of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypersensitivity
Clinical narrative: Felt as though she was going to faint 20 minutes after receiving the vaccine; Feel weak; Dizzy; severe allergic reactions; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 25-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The medical history and concomitant medications of the patient were not reported. It was reported that the patient began to feel weak, dizzy and felt as though she was going to faint 20 minutes after receiving the vaccine and had severe allergic reactions on an unspecified date. Patient reported that she started to feel dizzy 20 minutes after the vaccine dose. The patient wanted to know if they were the side effects of the Pfizer Covid vaccine. The outcome of the events was reported as unknown.  Information on lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea, Electrocardiogram
Clinical narrative: shortness of breath/dyspnea; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0171) via an unspecified route of administration (age at vaccination 57-year) in Left Arm on 22Jun2021 14:45 PM as dose 1, single for COVID-19 immunization. The reported vaccination Facility Type was pharmacy. Medical history included congestive heart failure and COVID-19 from 25Dec2020 to an unknown date. The patient's concomitant medications were not reported. There was no history was reported of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). On 23Jun2021 the patient experienced shortness of breath/dyspnea. The patient states she got Pfizer COVID 19 vaccine at (withheld), Clarified she had the first dose; The next day in the morning she noticed the shortness breath. It gets worse on and off. Today it is worse. Reports today when the aid got here, by the time she got to the shower and tried to get in shower, she couldn't get in the shower, that is how short of breath she was. The patient reports she has been short of breath and can hardly breath. She went to the hospital last night; mentions she already has CHF, congestive heart failure; and she had COVID last year; she had caught COVID in 25Dec2020; but when she got to the doctor, she was not having congestive heart failure; there was no fluid; and no pneumonia. Clarifies she was seen in the emergency room on Wednesday night 30Jun2021 but not admitted to the hospital. While providing family history, caller mentions her sister had the COVID 19 vaccination and also had shortness of breath. A clone report is created to document the sister's experience. This is report one of two. The patient underwent lab tests and procedures which included chest X-ray: negative and electrocardiogram: negative on 30Jun2021. The clinical outcome of the event was unknown.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021832272 same reporter/drug/event, different patient
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Fall, Feeling cold, Tunnel vision
Clinical narrative: Atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vaccine.; Tunnel vision; Extreme sense of coldness; Face planted to the floor.; This is a spontaneous report from a contactable consumer or other non hcp. This consumer(patient) reported for himself thata 41-years-old male patient received first dose of BNT162B2 (Formulation: Solution for injection, Batch/Lot number: 59267-1000-01), via an unspecified route of administration, administered in Arm Right on 25Jun2021 18:00 (Age at vaccination 41 years) as single dose for COVID-19 immunisation. Medical history included hiatus hernia and diverticulitis. Concomitant medication(s) included paracetamol (TYLENOL). Patient had no known allergies. On 25Jun2021 18:00, the patient experienced atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vaccine; tunnel vision; extreme sense of coldness and face planted to the floor. Patient was received treatment for events. It was reported that after patient received shot and exited the medical room, he had extreme sense of coldness come over me, tunnel vision, then face planted to the floor. Ambulance was called, patient regained consciousness about a minute or so later, and my chin was split open. They took me to ER, stapled my chin, and ran tests. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Other medications the patient received within 2 weeks of vaccination include Tylenol. Patient received Cardizem 1/day till doc follow-up visit. The clinical outcome of all events were unknown.  Information on the lot/batch number has been requested.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: He has tested positive 30JUN2021 with symptoms of stuffy/runny nose; This is a spontaneous report from contactable reporter (patient mother) via COVAX US Support. A 15-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729, Expiry Date: Unknown), via an unspecified route of administration, administered in the left arm on 24Jun2021 at 14:00 (at the age of 14-year-old) as a single dose for covid-19 immunisation at Hospital. The patient had no medical history and did not administered any concomitant medications. The patient does not take any regular medications or have any other medical conditions. Reporter stated no, thank God, he's healthy. Patient did not receive any prior vaccinations (within 4 weeks) and AE following prior vaccinations. The patient had no family medical history. The patient went through a drive through Covid-19 screening facility at the health department. Patient received his first dose of the Pfizer Covid-19 vaccine on 24Jun2021. He was exposed to Sars-COV-2 on 26Jun2021 on his birthday and after 6 days from vaccination, patient tested positive, which was confirmed by PCR test on 30Jun2021 and had a stuffy/runny nose. She (patient mother) reported that he had another Covid-19 PCR test done today, 02Jul2021, but they do not have results yet. She stated that there is a small chance that the patient received a false positive on Wednesday, 30Jun2021, but you never know, and she enquired if the patient's PCR test from today, 02Jul2021, came back negative, would he still be able to get the second dose of the Covid-19 vaccine after 3 weeks. Currently awaiting for PCR test, antigens test resulted negative. She enquired whether she should delay the second dose of the Covid-19 vaccine or not for her son. HCP indicated to wait ninety days for second dose. The patient underwent lab tests and procedures which included sars-cov-2 PCR test, which was positive on 30Jun2021, 2 Covid-19 antigen tests which were negative on 30Jun2021, Covid 19 PCR test unknown, has not resulted yet on 02Jul2021. The event did not result in emergency room or physician office. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia
Clinical narrative: metallic taste; she didn't lose taste completely; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration, on 01Jul2021 (Yesterday), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Jul2021, the patient had experienced metallic taste in the mouth, she read up on it, she didn't lose taste completely. She wants to know if it is a normal side effects and how long it lasts. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypotension, Vertigo
Clinical narrative: Checked blood pressure has always been about 130/60 but has been at  85 and 90 systematic since; vertigo and extreme dizziness; vertigo and extreme dizziness; This is a spontaneous report from contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ew0179), via an unspecified route of administration in right arm on 18May2021 at 13:00 (at the age of 42-year-old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21May2021 at 12:00, a few days after shot experienced vertigo and extreme dizziness lasting about a week. Checked blood pressure has always been about 130/60 but has been at 85 and 90 systematic since. It was unknown whether treatment was received for events. The patient underwent lab tests and procedures which included blood pressure: 130/60 mmhg on an unknown date (Checked blood pressure has always been about 130/60 but has been at 85 and 90 systematic since), blood pressure: 85 and 90 mmhg on an unknown date in May2021. The outcome of vertigo and extreme dizziness was reported as resolved on 28May2021, hypotension was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's friend) reported for patient (reporter's friend) of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The consumer states he had a friend who got the Pfizer vaccine and "the second dose almost killed him." No additional details provided as this comment was made in passing conversation. The outcome of the event was unknown. Information about Lot/batch number is requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Influenza
Clinical narrative: got sick; she got little bit cough and begin Flu; she got little bit cough and begin Flu; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Mar2021 as Dose 1,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient got sick and was not able to get the 2nd dose on time. She plans to take it in August. She was supposed to get her second dose but she got little bit cough and she got to begin Flu or something she didn't care, now trying to get her second dose vaccine. I wanted to know if the event dose she is planning for second dose in Aug2021, my question is, if I needs to restart whole process or just need to take the second dose. She is asking if that would be okay or should she repeat the 1st dose. The outcome of the events illness, cough, influenza was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain in extremity
Clinical narrative: neuropathy of the feet; sore arm; This is a spontaneous report from Pfizer-sponsored programs, Pfizer RxPathways and Pfizer Patient Assistance and Savings Program for Lyrica and Lyrica CR, from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports.   A 74-year-old male patient received BNT162B2, via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The patient previously took pregabalin (LYRICA) for neuropathy of feet. The reporter stated during inbound call, the patient received vaccine back in Mar2021 and it had worked great. The patient had a really sore arm on an unspecified date, reported "they stick with a big needle". It worked out great for the patient. The patient had neuropathy of the feet and he needed medicine pregabalin (LYRICA). The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021829969 same reporter, different patients, same drug
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain in extremity
Clinical narrative: neuropathy of the feet; sore arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is the second of 2 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date in Mar2021 as single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient previously took pregabalin (LYRICA) for neuropathy of feet. The reporter stated during inbound call, the patient received vaccine back in Mar2021 and it had worked great. The patient had a really sore arm on an unspecified date, reported "they stick with a big needle". It worked out great for the patient. The patient had neuropathy of the feet and he needed this medicine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021829966 same reporter/drug/event, different patients
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Pulmonary oedema, Vaccination site pain, Wheezing
Clinical narrative: Her lungs were full of fluid; Few days after first dose left sided chest achiness.; First dose the next morning she was wheezing and had to take a breathing treatment, resolved; At the injection site both times, she had a lot of injection pain.; This is a spontaneous report received from a contactable consumer or other non hcp. The contact-able consumer described events for both doses of bnt162b2. This report describes events for the first dose. A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0217) via an unspecified route of administration in Arm Left on 06Jun2021 as single dose for covid-19 immunisation. Medical history included food allergy, allergy to drugs, allergy to animal cats, pollen, allergy to plants trees, grass, asthma from since she was 11 and unknown if ongoing, thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, start and stop date were not reported; salbutamol (ALBUTEROL HFA) taken for asthma, start and stop date were not reported. The patient underwent lab tests and procedures which included computerised tomogram: ruptured on unspecified date. The patient experienced at the injection site both times, she had a lot of injection pain on 06Jun2021, first dose the next morning she was wheezing and had to take a breathing treatment resolved on 07Jun2021, her lungs were full of fluid, few days after first dose left sided chest achiness on an unspecified date. The clinical outcome of the event wheezing was resolved, and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine with aura
Clinical narrative: Migraine after each  doses with aura; have headaches very often - sometimes quite severe and I am still having headaches; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old female non pregnant patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: ER2613) via an unspecified route of administration and administered in right arm on 23Mar2021 08:00 (at age of 59 years) as single dose and dose 2 via an unspecified route of administration and administered in right arm on 13Apr2021 08:00 (BNT162B2, solution for injection, Batch/Lot Number: EW0158) as single dose for COVID-19 immunization. The patient medical history include High cholesterol and allergic to sulfa drugs. No covid prior vaccination. There were no concomitant medications. There was no other vaccine in four weeks, no other medications in two weeks. Since vaccination the patient was not tested for COVID-19. On 27Mar2021, the patient experienced migraine after each doses with aura. The first was four days after the first dose. The second was after the second dose. the patient have never had a migraine before and never had recurring headaches before. Since then she have headaches very often- sometime quite severe and she is still having headaches. At first she didnt think it was connected to the vaccine but then when she reviewed the timing and she questioned it. The events leads to Doctors office/urgent care and doesnt leads to hospitalization. No therapeutic measures were taken for events. The outcome of events was unknown.  Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain in extremity, Tenderness
Clinical narrative: Caller reports after having her 1st dose of the vaccine having pain in her "under arm" and assumes this is in her lymph nodes; Pain in arm; tender; This is a spontaneous report from contactable nurse (patient) reported for herself that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, expiry date and NDC number, Batch/Lot number was not reported), via an unspecified route of administration on 24Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had her first vaccine on 24Jun2021. After that on an unspecified date in 2021 patient had the usual pain in her arm that subsided 2 days later. States that in that time period patient began feeling pain in her underarm, patient assumes its lymph nodes; The patient states that it was tender and ongoing on an unspecified date in 2021, that it was still there. The patient was asking if this does not subside does she get the 2nd dose of the vaccine. The outcome of the event pain in arm was recovered on an unknown date in 2021, however the other events was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Diagnosis: Inflammation around the heart; This is a spontaneous report received from a contactable consumer (patient). A 30-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route in right arm on 06May2021 as single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0182) via an unspecified route on 06May2021 for covid-19 immunisation. The patient 's medical history included Covid-19 on unspecified date. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other vaccines within 2 weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Jun2021 at 11:00, the patient experienced and diagnosed inflammation around the heart. Patient visited emergency room and received treatment for event. The patient had hospitalization for 7 days. The outcome of the event was unknown.  Follow-Up (06Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Heavy/tight heart; This is a spontaneous report received from a contactable consumer or other non hcp. A 45-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955), Solution for injection, intramuscularly, administered in Arm Left on 12Apr2021 (at the age of 45-year-old) as single dose for covid-19 immunisation. Medical history reported as none. Patient was not allergic. The patient's concomitant medications were not reported. 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 and she did not receive any other medication within two weeks. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955), Solution for injection, intramuscular, administered in Arm Left on 23Mar2021 as single dose for covid-19 immunisation. On 12Apr2021, the patient experienced heavy/tight heart. Event was reported as non-serious by the reporter. Patient did not receive treatment due to adverse events. The outcome of events was reported as not recovered.  Follow-up actions are needed. Further information has been requested.  Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Circumstance or information capable of leading to medication error, Fatigue, Headache, Vomiting
Clinical narrative: Her husband would like to receive Johnson & Johnson for second dose instead of Pfizer covid vaccine; chills; vomiting for 24 hours; fatigue; head ache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer or other non hcp (patient's wife) reported for a male patient (reporters husband) that patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 22Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date Feb2021, the patient experienced chills, vomiting for 24 hours, fatigue, head ache, and her husband would like to receive johnson & johnson for second dose instead of pfizer covid vaccine. Caller wants to know if it would be safe to receive Johnson & Johnson covid vaccine for second dose instead of Pfizer covid vaccine. The outcome for all the events was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Electrocardiogram, Gastrooesophageal reflux disease, Hepatic cirrhosis
Clinical narrative: Something is getting in the way in his throat .; stage 1 varices/some type of clot or thrombosis; Thrombocytopenia; Cirrhosis of the liver; stage 1 varices/some type of clot or thrombosis; Recently started having acid reflux and pain in his chest; Recently started having acid reflux and pain in his chest; This is a spontaneous report from a contactable consumer (patient brother). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 as single dose, dose 2 via an unspecified route of administration on an unspecified date in Mar2021 as single dose for Covid-19 immunization. Medical history included ongoing thrombocytopenia. The patient and his twin brother both have thrombocytopenia. The patients concomitant medications were not reported. On an unspecified date in Mar2021 the patient experienced thrombocytopenia, cirrhosis of the liver. On an unspecified date in 2021 recently started having acid reflux and pain in his chest, in Mar2021 patient had stage 1 varices/ some type of clot or thrombosis, in Jun2021, something was getting in the way in his throat. The patient underwent lab tests and procedures which included blood work: excellent on an unspecified date in 2021. It can't be cirrhosis because he has excellent blood work, electrocardiogram (ECG): abnormal on an unspecified date in Mar2021. They found stage I varices/ some type of clot or thrombosis and cirrhosis of the liver where he had had neither, previously, oesophagogastroduodenoscopy (EGD): had nothing like this when they did the last one in 2018, abnormal on an unspecified date in Mar2021. They found stage I varices/ some type of clot or thrombosis. The outcome of events was unknown.  Information about lot/batch number is requested.