chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable consumer(patient). The 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 01Apr2021 12:45 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation.  Medical history included attention deficit hyperactivity disorder (ADD).There was no known allergies, no Covid prior vaccination. The patient's concomitant medications were not reported.  The patient experienced myocarditis on 18Apr2021 23:30 which led to emergency room with outcome of unknown. There was no treatment.   Information on the lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: weakness in the legs; This is a spontaneous report from a contactable consumer.   A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 06Apr2021 (Batch/Lot Number: ER8734) as 1st dose, single (at the age of 63 years old) for COVID-19 immunisation.  Medical history included ongoing high blood pressure diagnosed 4 to 5 years ago, ongoing diabetes diagnosed 10 years ago and ongoing bone cancer diagnosed about 2 years ago.  The patient's concomitant medications were not reported.  The patient experienced was in and out for different things. He was hospitalized for weakness in the legs on 28Apr2021. Patient was supposed to get second COVID19 vaccine on 28Apr2021 but was hospitalized for unrelated issues. The patient wants to know where to get second dose. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Peripheral swelling
Clinical narrative: Swollen on one of the legs; swollen and hurt knee; swollen and hurt knee; This is a spontaneous report received from a contactable consumer (friend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen on one of the legs and swollen and hurt knee on an unspecified date. It was reported that the reporter's friend told her that she went to her doctor (at the hospital) about her knee and she said it was swollen and hurt on the side of her leg she was swollen. She did not know if she bumped into anything, but all of a sudden, the swelling came up on her leg. The clinical outcome of swollen on one of the legs and swollen and hurt knee was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Hypertension
Clinical narrative: Hypertension; Blood pressure is up and down; This is a spontaneous report from a contactable nurse (sister). A female patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has hypertension now. She is on medication now because of the hypertension. Patient called her doctor again and her cardiologist. Blood pressure is up and down. She has been put on statins and beta blockers. When she sits up her blood pressure goes up. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, SARS-CoV-2 test, Thrombotic thrombocytopenic purpura
Clinical narrative: acquired TTP (thrombotic thrombocytopenic purpura); This is a spontaneous report from a contactable physician. A 15-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via intramuscular route on 10Apr2021, at the age of 15 years, (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. On 20Apr2021 the patient experienced acquired thrombotic thrombocytopenic purpura (TTP) which required the patient's hospitalization for 8 days, moreover the BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine was administered to patient of inappropriate age. The acquired TTP was formally diagnosed on 29Apr2021 but symptoms started on 20Apr2021, approximately 10 days after first vaccine dose. On 29Apr2021 the patient underwent lab tests and procedures which included SARS-CoV-2 test via nasal swab which was negative. As a result of acquired TTP the patient was treated with plasmapheresis, corticosteroids and rituximab. The event acquired TTP was resolving at the time of the report.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available a causal relationship between event "acquired thrombotic thrombocytopenic purpura" occurred approximately 10 days after first vaccine dose and BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine cannot be completely excluded.  The case will be reevaluated should additional information become available. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to investigators, as appropriate.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Bacteraemia, Febrile neutropenia, SARS-CoV-2 test
Clinical narrative: Neutropenia fever - polymicrobial bacteremia; Neutropenia fever - polymicrobial bacteremia; This is a spontaneous report from a contactable physician. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) (at the age of 55 years old) as a single dose for COVID-19 immunisation. Medical history included pancytopenia from an unknown date and unknown if ongoing and prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Apr2021, the patient experienced neutropenia fever - polymicrobial bacteremia, which required hospitalization for 5 days. The patient underwent lab tests and procedures which included SARS-COV-2 test (nasal swab): negative on 01May2021. Therapeutic measures taken as a result of neutropenia fever - polymicrobial bacteremia included IV antibiotics. The outcome of the events neutropenia fever - polymicrobial bacteremia was recovered on 05May2021.  Follow up needed, further information has been requested.; Sender's Comments: Based on available information and known drug profile the reported "neutropenia fever - polymicrobial bacteremia" are unlikely related to  BNT162B2.  These are probably intercurrent  medical conditions in a patient  with a history of pancytopenia and COVID-19 infection.  Case will be reassessed if additional information is received.  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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Hypoaesthesia oral, Lip swelling, Pain in extremity, Paraesthesia oral
Clinical narrative: Minor allergic reaction; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; sore arm; This is a spontaneous report from a contactable consumer (the patient).  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0151), dose 1, single dose via an unspecified route of administration, administered in arm  left on 14Apr2021 for covid-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. Past drug event included allergy to ampicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced minor allergic reaction, swollen, tingling, and numb tougue and lips and sore arm on 14Apr2021. Therapeutic measures taken as a result of minor allergic reaction, swollen, tingling, and numb tougue and lips. and sore arm included diphenhydramine (BENADRYL). The outcome of minor allergic reaction, swollen, tingling, and numb tongue and lips, sore arm  was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of minor allergic reaction cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Minor allergic reaction; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; sore arm; This is a spontaneous report from a contactable consumer (the patient).  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0151), dose 1, single dose via an unspecified route of administration, administered in arm  left on 14Apr2021 for covid-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. Past drug event included allergy to ampicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced minor allergic reaction, swollen, tingling, and numb tougue and lips and sore arm on 14Apr2021. Therapeutic measures taken as a result of minor allergic reaction, swollen, tingling, and numb tougue and lips. and sore arm included diphenhydramine (BENADRYL). The outcome of minor allergic reaction, swollen, tingling, and numb tongue and lips, sore arm  was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of minor allergic reaction cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Painful respiration, Pulmonary embolism
Clinical narrative: severe pain when breathing which resulted in bilateral pulmonary embolisms, DVT in right calf, non-occipital; severe pain when breathing which resulted in bilateral pulmonary embolisms, DVT in right calf, non-occipital; severe pain when breathing which resulted in bilateral pulmonary embolisms, DVT in right calf, non-occipital; This is a spontaneous report from a contactable consumer reporting for herself. A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 07Apr2021 at 08:00 (Batch/Lot Number: EP7533) (at the age of 47 years old) as a single dose  for COVID-19 immunisation.  The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 08:00 (Batch/Lot Number: EN6204) (at the age of 47 years old) as a single dose  for COVID-19 immunisation. Medical history included factor v deficiency from an unknown date and unknown if ongoing, protein c deficiency from an unknown date and unknown if ongoing. The patient did not have any known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included venlafaxine hydrochloride (EFFEXOR XR) taken for an unspecified indication, start and stop date were not reported; ibuprofen taken for an unspecified indication, start and stop date were not reported; diclofenac potassium (VOLTAREN ACTI) taken for an unspecified indication, start and stop date were not reported; spironolactone (SPIRONOLACTONE) 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 12Apr2021 at 14:00, the patient experienced severe pain when breathing which resulted in bilateral pulmonary embolisms, deep vein thrombosis (DVT) in right calf, non-occipital. The events severe pain when breathing which resulted in bilateral pulmonary embolisms, deep vein thrombosis (DVT) in right calf, non-occipital required a physician's office visit, emergency room visit and hospitalization for 1 day. The outcome of the events severe pain when breathing which resulted in bilateral pulmonary embolisms, deep vein thrombosis (DVT) in right calf, non-occipital was recovered in Apr2021. Since the vaccination, the patient had not been tested for COVID-19.   Follow-up needed, further information has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Blood test, COVID-19, Electrocardiogram, Myocarditis
Clinical narrative: nstemi; Myocarditis; This is a spontaneous report from a contactable physician. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) via an unspecified route of administration on 26Apr2021, SINGLE for covid-19 immunization. The patient's medical history was not reported.  The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 27Apr2021, the patient reported to the hospital with complaints of chest pain with electrocardiogram (EKG) showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers. On 27Apr2021, the patient experienced non-ST-elevation myocardial infarction (NSTEMI) and myocarditis. The patient was hospitalized for one day. and the event required an emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood test: negative on 02May2021, covid-19: negative on 02May2021, electrocardiogram: unknown showing non-diagnostic diffuse ST  elevations and elevated cardiac biomarkers, myocarditis: unknown. Cath report did not reveal coronary artery disease (CAD). Therapeutic measures were taken as a result of NSTEMI (acute myocardial infarction), myocarditis (myocarditis), chest pain (chest pain), EKG showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers. The outcome of non-ST-elevation myocardial infarction (NSTEMI), myocarditis, chest pain and electrocardiogram (EKG) showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers was recovered on an unknown date. It was also reported that since the vaccination, the patient was tested for COVID-19 on 02May2021 and was negative.   Information on lot number/batch number was requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case.  Based on currently known drug profile it is unlikely that events non-ST-elevation myocardial infarction (NSTEMI) and myocarditis are related to BNT162B2. This case will be re-evaluated upon receipt of additional information. 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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity, Pulmonary embolism
Clinical narrative: 3 pulmonary embolisms; he started having really bad headaches; he was complaining of the back of his leg hurting; his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as; This is a spontaneous report from a contactable consumer.   A 42-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0172, Expiration Date 31Aug2021) via an unspecified route of administration, on 28Apr2021 at 09:00 (at the age of 42-years-old) as a single dose in the left "shoulder" for COVID-19 immunization. The patient's medical history and concomitant medications were denied (reported as "He has no medical conditions and does not take any regular medications"). The patient did not receive any other vaccinations within four weeks prior to the vaccine. The reporter says she is reporting on behalf of her husband with regard to the Pfizer COVID vaccination. She just wanted to report that her husband got the first shot 28Apr2021 and Friday 07May2021 he was admitted to the hospital with 3 pulmonary embolisms. When asked when the pulmonary embolism began she says the week before the hospitalization, so the week he actually got the first dose, he was complaining of the back of his leg hurting, in the upper calf area. She says it was either the day after the shot or the next day that he said his leg hurt but he did not think too much about it and it resolved after a couple days and then Wednesday, 05 May 2021 he started getting discomfort in his left upper quadrant, she clarifies his abdomen and rib cage area, and he started having really bad headaches Thursday that continued and during the night  Thursday night his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as he had the severe headache so the doctor told him to go to the ER. The patient experienced three pulmonary embolisms on an unspecified date with outcome of not recovered. The patient was hospitalized for 3 pulmonary embolisms from 07May2021 to 08May2021. He also started having really bad headaches on an unspecified date with outcome of unknown and he was complaining of the back of his leg hurting on an unspecified date with outcome of recovered, his left shoulder started bothering him and it was radiating from his shoulder up to his chin on an unspecified date with outcome of unknown. The reporter commented that she and her husband wanted to report this because of the timing of getting the shot and they are waiting now to go see his primary care they are supposed to be calling to set up an appointment because he is supposed to be having the second dose 19May2021 so they do not know what is going to happen. Therapeutic measures were taken as a result of pulmonary embolism and included Eliquis which he would be on for at least 3 months.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, in the left arm on 29Apr2021 at 13:10 (Batch/Lot Number: EW0167, at the age of 75 years) as a single dose for COVID-19 immunization at a pharmacy drug store. Medical history included knee operation on 09Nov2020 and ongoing high blood pressure. The patient did not receive any other vaccinations within 4 weeks of the COVID-19 vaccine. Concomitant medications included unspecified blood pressure medication from an unspecified date and ongoing, several unspecified pain medications from an unspecified date following the knee surgery and ongoing and other unspecified medications in addition to the pain and blood pressure medications. On 29Apr2021 at 13:10, the patient received the first dose of the COVID-19 vaccine. On 29Apr202 at 13:25, 15 minutes after the vaccination, she experienced a heart attack. She described that it felt like she had very severe heartburn. She also became very weak and felt weak all the time. Her doctor called while she felt like she had very severe heartburn. She reports that her physician heard her panting during the phone call and said she was having a heart attack. She took Tums and the severe heartburn went away. It was a small bottle of Tums and she took half of the bottle. By the time she got home she was ok and didn't believe that she was having a heart attack. One of the physicians came to her home on 29Apr2021. The physician did an EKG and confirmed that she did have a heart attack. The patient stated that she knew the vaccine caused the heart attack and she was not going to get the second dose of the vaccine. The patient stated that she has no medical history or family history of hear attacks. Emergency room visit was not required. The outcome of event heart attack was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID/ tested positive for COVID-19; got COVID/ tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist. A female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route on 29Mar2021 as a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient received the first dose on 29Mar2021 and then got COVID between doses. The patient tested positive for COVID-19 on 20Apr2021. She was supposed to get the second dose on 21Apr2021, which she missed; she was told she'd have to wait 90 days. The reported wanted to know if okay now to get the second dose since patient feels fine. She quarantined and feels better. The clinical outcome of got COVID/ tested positive for COVID-19 was recovered on unspecified date.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity after the first vaccine dose.,Linked Report(s) : US-PFIZER INC-2021527897 same reporter/patient/drug, different event in separate dose
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: vagina bleeding before menstruation; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, into left arm on 04May2021 (at the age of 23-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included pumpkin allergy. Patient was not pregnant. Concomitant medication includes generic oral contraceptives. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) into left arm on 15Apr2021 (at the age of 23-year-old) for COVID-19 immunization and experienced random episodes of dizziness about once per week. On an unspecified date after the administration of the 2nd dose, patient experienced vagina bleeding before menstruation. The patient did not receive treatment for the event reported. The patient underwent lab tests and procedures which included SARS-CoV-2 test (nasal swab): negative on 19Apr2021, negative on 26Apr2021 and negative on 03May2021. Outcome of event was not recovered.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram, Cough, Pain, Pneumonia
Clinical narrative: really bad body aches; Cough / awful, deep, rattily cough; awful, deep, rattily cough; Pneumonia/had xray, showed left lung pneumonia; This is a spontaneous report received from contactable consumer, the patient. A 74-year-old elderly female received the second dose of intramuscular BNT162b2 (solution for injection; Lot EN6199 and expiry information not provided) as a single dose in the right deltoid on 18Mar2021 (at 74-years-old) for COVID-19 immunization. Relevant medical history included diagnosed allergies, asthma, bronchial cough, pneumonia (not within since 2019), rheumatoid arthritis, compromised immune status, genetic/chromosomal abnormalities, and endocrine abnormalities. There were no concomitant medications reported. The patient previously received the first dose of intramuscular BNT162b2 (solution for injection; Lot EN6198 and expiry information not provided) as a single dose in the right deltoid (arm muscle) on 25Feb2021 (at 74-years-old) for COVID-19 immunization. The patient reported that she had a weird reaction in Mar2021 after second Pfizer vaccine. The patient explained that she had the second Pfizer COVID-19 vaccine on 18Mar2021 and was fine for two days and then she had the other symptoms, really bad body aches. States she has really bad rheumatoid arthritis already, but the pains/aches started the night of 21Mar2021 and were so bad she called the doctor. Was told that she cannot take any steroids because it will affect the vaccine and that the pain will go away after two days, and it did go away in two days. The patient also reported that although she had a bronchial cough, it got worse and was a deep cough. The patient reported that she already has asthma and a bronchial cough, but after ten days of still coughing she thought to get it checked out at a walk in clinic where she had an x-ray and was told there it was pneumonia. The patient stated that she guesses she had it all along over the asthma and bronchial issues. She has not had pneumonia in over 2 years. Denied having any fever or chills it was just this awful, deep, rattily cough and the x-ray confirmed that the left lung had pneumonia. Had the cough the 21Mar2021 and it was practically going away, but not completely. The doctor cleared her of pneumonia as of 04May2021, reported as last Tuesday, with another x-ray. States that one x-ray was a confirmation and she was put on a very strong antibiotic, which she did not improve and so she went for another x-ray on the 12Apr2021 and it showed there was no improvement. She had quite a time with it and was then put on a steroid taper and had a computerized assisted tomographic (CAT) scan and another round of antibiotics. Caller unable to provide names, NDC, Lot, or expiry for any of the antibiotics or steroids treated with. The outcome of the event really bad body aches was recovered on 23Mar2021 after two days. The outcome of the events cough/ awful, deep, rattily cough and pneumonia was recovering.   Follow up needed, further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: really bad body aches; Cough / awful, deep, rattily cough; awful, deep, rattily cough; Pneumonia/had xray, showed left lung pneumonia; This is a spontaneous report received from contactable consumer, the patient. A 74-year-old elderly female received the second dose of intramuscular BNT162b2 (solution for injection; Lot EN6199 and expiry information not provided) as a single dose in the right deltoid on 18Mar2021 (at 74-years-old) for COVID-19 immunization. Relevant medical history included diagnosed allergies, asthma, bronchial cough, pneumonia (not within since 2019), rheumatoid arthritis, compromised immune status, genetic/chromosomal abnormalities, and endocrine abnormalities. There were no concomitant medications reported. The patient previously received the first dose of intramuscular BNT162b2 (solution for injection; Lot EN6198 and expiry information not provided) as a single dose in the right deltoid (arm muscle) on 25Feb2021 (at 74-years-old) for COVID-19 immunization. The patient reported that she had a weird reaction in Mar2021 after second Pfizer vaccine. The patient explained that she had the second Pfizer COVID-19 vaccine on 18Mar2021 and was fine for two days and then she had the other symptoms, really bad body aches. States she has really bad rheumatoid arthritis already, but the pains/aches started the night of 21Mar2021 and were so bad she called the doctor. Was told that she cannot take any steroids because it will affect the vaccine and that the pain will go away after two days, and it did go away in two days. The patient also reported that although she had a bronchial cough, it got worse and was a deep cough. The patient reported that she already has asthma and a bronchial cough, but after ten days of still coughing she thought to get it checked out at a walk in clinic where she had an x-ray and was told there it was pneumonia. The patient stated that she guesses she had it all along over the asthma and bronchial issues. She has not had pneumonia in over 2 years. Denied having any fever or chills it was just this awful, deep, rattily cough and the x-ray confirmed that the left lung had pneumonia. Had the cough the 21Mar2021 and it was practically going away, but not completely. The doctor cleared her of pneumonia as of 04May2021, reported as last Tuesday, with another x-ray. States that one x-ray was a confirmation and she was put on a very strong antibiotic, which she did not improve and so she went for another x-ray on the 12Apr2021 and it showed there was no improvement. She had quite a time with it and was then put on a steroid taper and had a computerized assisted tomographic (CAT) scan and another round of antibiotics. Caller unable to provide names, NDC, Lot, or expiry for any of the antibiotics or steroids treated with. The outcome of the event really bad body aches was recovered on 23Mar2021 after two days. The outcome of the events cough/ awful, deep, rattily cough and pneumonia was recovering.   Follow up needed, further information has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I developed shingles.   First sign May 1, first rash May 2, diagnosed May 6; This is a spontaneous report received from a contactable consumer.  A 45-year-old male consumer (patient) reported that received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EW0151), into the left arm on 06Apr2021 09:15 (at the age of 45-years-old) at single dose for COVID-19 immunization. The patient had received first dose of vaccine on 9Mar2021 09:15 AM (lot Number: EN6206) in Arm Left.  Medical history was none.  The patient's concomitant medications were none.   The consumer reported that developed shingles. First sign on 01May2021, first rash on 02May2021, and was diagnosed on 06May2021. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment with 'medicine'. Since the vaccination,  the patient has not been tested for COVID-19. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Eating disorder, Hypoaesthesia, Investigation, Loss of consciousness
Clinical narrative: ended up passing out right there; feeling hands and legs num; feeling very week; having hard time eating or drinking anything; This is a spontaneous report from a contactable consumer(patient). A 19-year-old female patient(not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 07May2021 03:30 (Lot Number: EW0158) as 2nd dose, single for covid-19 immunization. Medical history and concomitant medications were none. There was no other vaccines within 4 weeks prior to the COVID vaccine, no other medications the patient received within 2 weeks of vaccination. There was no known allergy. She was not diagnosed with COVID-19. Historical vaccine included first dose of BNT162B2 on 15Apr2021 at 03:00(Lot No.: EWO173) in arm left for COVID-19 immunisation. It was stated that 2 days after the second dose, on 09May2021 she was at work and start feeling hands and legs num . She was at the cashier and ended up passing out right there. She was rushed to ER(Emergency room) and she could feel or move her last for at least 30 minutes. She was afraid she would not be able to walk again. She was treated and after 3-4 hours they discharged herself saying it was a reaction to the vaccine. She had been home since then and still (4 days after the shot ) having a hard time eating, or drinking anything in May2021. She was still feeling very week in May2021. Treatment for ended up passing out right there, feeling hands and legs num included just a bunch of exams were done and everything see in May2021. Outcome of ended up passing out right there, feeling hands and legs num was recovering, of other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Spinal fracture
Clinical narrative: broke her back; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient was hospitalized since she broke her back. The patient was scheduled for her second dose on 18Apr2021 but missed it since the patient was in the hospital. The reporter queried whether the patient could get the second dose or start over. The nurse stated that the patient "was admitted to the hospital had nothing to do with the vaccine, patient was in the hospital since she broke her back". The clinical outcome of "broke her back" was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The event "broke her back" is attributed to an intercurrent medical condition and assessed Unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE).
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: very sudden and dramatic breakthrough/period-like bleeding around about the time I ought to be ovulating.(14days after shot); This is a spontaneous report from a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient stated,"I had my second dose of your covid vaccine on the 22nd (the day after I got my period). I'm still experiencing side effects, I probably won't be out of bed for at least another couple of days. The most recent one is I got very sudden and dramatic breakthrough/period-like bleeding around about the time I ought to be ovulating.(14 days after shot; May2021) Do you have a link or number to call to report all the side effects?". The outcome of event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report from a contactable consumer (patient's husband) through a Pfizer sales representative. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, two weeks after vaccination, the patient had a heart attack. The outcome of the event was unknown. The patient's cardiologist called it a "mysterious case".  Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: received first dose 29Mar, contracted covid; received first dose 29Mar, contracted covid; This is a spontaneous report from a .  A contactable consumer reported that female patient of an unknow age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), intramuscular  on 29Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. It was reported that the patient contracted COVID-19 on an unknown date after vaccine administration. The patient missed second dose (scheduled at 23 days, 21Apr), and wanted to know if it is right to get second dose at the time of reporting that she feels fine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Was not feeling well enough to go; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, 1st dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient missed her second dose of the COVID-19 vaccine, which was due on 10May2021, because she woke up in the morning and was not feeling well enough to go. The patient did not specify symptoms but stated that she felt it was not related to the vaccine. The patient asked if the second dose of the vaccine has to be given at the same vaccination site as the first dose. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information in the case report, A causal relationship between reported event and suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19
Clinical narrative: Left wrist pain; This is a spontaneous report from a contactable consumer (patient).   A 31-year-old male patient received second dose of bnt162b2 (BNT162B2), intramuscular, administered in left arm on 24Feb2021 09:39 (Lot Number: EM9809) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included hypertension from 30Sep2020 and ongoing, humerus fracture from 11Jul2017 to 20Sep2019, and humeral fixation with plats. Historical vaccine includes first dose of BNT162B2 received on 03Feb2021 at 09:40 in left arm intramuscular (Lot number: EL9262). Concomitant medication included lisinopril taken for hypertension one tablet a day.  On 26Feb2021, the patient experienced left wrist pain, assessed as medically significant. The event required visit to physician's office.  The patient underwent lab tests and procedures which included Covid-19: negative on 15Jan2021. The outcome of the event was not recovered. Therapeutic measures were taken as a result of left wrist pain which includes Ibuprofen, need orthopedic surgeon examination next.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure decreased, Blood pressure measurement, Body temperature, Chest X-ray
Clinical narrative: labs are abnormal; blood pressure dropping; Then 8 days later i developed throbbing pain head to toe; low grade temp; sweats; swelling of joints, especially my fingers, hands and feet; swelling of joints, especially my fingers, hands and feet; diarrhea; dizziness; problems thinking; anxiety; About 4 hours after receiving my Covid vaccine I started to feel fatigue/severe fatigue; This is a spontaneous report from a contactable Nurse (Patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 08Apr2021 16:00 (Batch/Lot Number: EK8734) at the age of 43-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient was not pregnant. Medical history included Rheumatoid Arthritis, fibromyalgia, anxiety/depression, Known allergies: Sulfa, Covid-19 prior vaccination. Post the vaccination, the patient was not been tested for COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. About 4 hours on 08Apr2021 after receiving her Covid vaccine she started to feel fatigue. Then 8 days later on 16Apr2021 08:00 AM, patient developed throbbing pain from head to toe, severe fatigue, low grade temp, sweats, swelling of joints, especially her fingers, hands and feet, diarrhea, blood pressure dropping, dizziness, problems thinking, and anxiety. His symptoms have progressively gotten worse and she had seen her family doctor, and her rheumatologist. Events resulted in: Doctor or other healthcare professional office/clinic visit. Leflunomide (ARAVA) and ibuprofen (MOTRIN) to help with inflammation and swelling. Her labs were abnormal, but chest X-ray normal on an unknown date. She have been off work since 26Apr2021. The outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Disturbance in attention, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: labs are abnormal; blood pressure dropping; Then 8 days later i developed throbbing pain head to toe; low grade temp; sweats; swelling of joints, especially my fingers, hands and feet; swelling of joints, especially my fingers, hands and feet; diarrhea; dizziness; problems thinking; anxiety; About 4 hours after receiving my Covid vaccine I started to feel fatigue/severe fatigue; This is a spontaneous report from a contactable Nurse (Patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 08Apr2021 16:00 (Batch/Lot Number: EK8734) at the age of 43-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient was not pregnant. Medical history included Rheumatoid Arthritis, fibromyalgia, anxiety/depression, Known allergies: Sulfa, Covid-19 prior vaccination. Post the vaccination, the patient was not been tested for COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. About 4 hours on 08Apr2021 after receiving her Covid vaccine she started to feel fatigue. Then 8 days later on 16Apr2021 08:00 AM, patient developed throbbing pain from head to toe, severe fatigue, low grade temp, sweats, swelling of joints, especially her fingers, hands and feet, diarrhea, blood pressure dropping, dizziness, problems thinking, and anxiety. His symptoms have progressively gotten worse and she had seen her family doctor, and her rheumatologist. Events resulted in: Doctor or other healthcare professional office/clinic visit. Leflunomide (ARAVA) and ibuprofen (MOTRIN) to help with inflammation and swelling. Her labs were abnormal, but chest X-ray normal on an unknown date. She have been off work since 26Apr2021. The outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Laboratory test, Laboratory test abnormal, Pain, Peripheral swelling
Clinical narrative: labs are abnormal; blood pressure dropping; Then 8 days later i developed throbbing pain head to toe; low grade temp; sweats; swelling of joints, especially my fingers, hands and feet; swelling of joints, especially my fingers, hands and feet; diarrhea; dizziness; problems thinking; anxiety; About 4 hours after receiving my Covid vaccine I started to feel fatigue/severe fatigue; This is a spontaneous report from a contactable Nurse (Patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 08Apr2021 16:00 (Batch/Lot Number: EK8734) at the age of 43-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient was not pregnant. Medical history included Rheumatoid Arthritis, fibromyalgia, anxiety/depression, Known allergies: Sulfa, Covid-19 prior vaccination. Post the vaccination, the patient was not been tested for COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. About 4 hours on 08Apr2021 after receiving her Covid vaccine she started to feel fatigue. Then 8 days later on 16Apr2021 08:00 AM, patient developed throbbing pain from head to toe, severe fatigue, low grade temp, sweats, swelling of joints, especially her fingers, hands and feet, diarrhea, blood pressure dropping, dizziness, problems thinking, and anxiety. His symptoms have progressively gotten worse and she had seen her family doctor, and her rheumatologist. Events resulted in: Doctor or other healthcare professional office/clinic visit. Leflunomide (ARAVA) and ibuprofen (MOTRIN) to help with inflammation and swelling. Her labs were abnormal, but chest X-ray normal on an unknown date. She have been off work since 26Apr2021. The outcome of the events was not recovered.