chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: About a few days or a week after getting the vaccine I noticed that my face and scalp was itching quite often as well as other body parts .  I was just starting to get over a month long period of extreme fatigue and other strange symptoms so maybe this itching was unrelated to the vaccine. The itching and sometimes prickly, pin-prick sensations  continued and I consulted a neurologist in early September. A series of blood tests were performed which were all negative. A skin biopsy showed some signs of nerve damage as did an electrical test on my legs. The Doctor put me on Gabapentin for symptom management.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Interchange of vaccine products, Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: I was very tired and and my arm was so soar for a couple of days and on the third day I noticed it was worse. It felt hot and was swollen and apparently it was the Modera arm rash. I have a concern because I had my first two shots with Pfizer with minimal reactions. I signed up to get Pfizer and they gave me Moderna even though I have an email to receive Pfizer. They said they get what they get. My arm is so soar and weak. I?m concerned.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin warm
Clinical narrative: I was very tired and and my arm was so soar for a couple of days and on the third day I noticed it was worse. It felt hot and was swollen and apparently it was the Modera arm rash. I have a concern because I had my first two shots with Pfizer with minimal reactions. I signed up to get Pfizer and they gave me Moderna even though I have an email to receive Pfizer. They said they get what they get. My arm is so soar and weak. I?m concerned.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Red hot rash on hard bump on arm below where injection was. Painful and tender.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, COVID-19 pneumonia, Chest X-ray abnormal, Lung opacity, Lymphopenia
Clinical narrative: Severe COVID Pneumonia 2 months after vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Electric shock sensation, Head discomfort, Headache, Incorrect route of product administration
Clinical narrative: pressure in head; COVID-19; COVID-19; shocks in body; Vertigo; Headache; PFIZER BIONTECH COVID-19/Subcutaneous; Pneumonia; This is a solicited report for a non-Pfizer sponsored program (FACILITATED COLLECT) received from contactable reporter (Consumer). The reporter is the patient. Other Case identifier(s): 21K-163-4166618-00.  A 62-year-old female patient received BNT162B2, subcutaneous, administration date 21Jul2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for COVID-19 immunisation; adalimumab, subcutaneous (Batch/Lot number: unknown) at 40 mg cyclic (1 in 2 wk) for moderate to severe rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 03Nov2021, outcome "not recovered" and all described as "COVID-19"; PNEUMONIA (medically significant) with onset 2021, outcome "unknown", described as "Pneumonia"; ELECTRIC SHOCK SENSATION described as "shocks in body", VERTIGO described as "Vertigo", HEADACHE described as "Headache" all (non-serious) with onset Aug2021, outcome "unknown"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "pressure in head"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Jul2021, described as "PFIZER BIONTECH COVID-19/Subcutaneous". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events Pneumonia, Drug ineffective, Suspected Covid19, Electric shock sensation, Vertigo, Head discomfort, Headache, Incorrect route of product administration and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pneumonia, Suspected COVID-19, Vertigo
Clinical narrative: pressure in head; COVID-19; COVID-19; shocks in body; Vertigo; Headache; PFIZER BIONTECH COVID-19/Subcutaneous; Pneumonia; This is a solicited report for a non-Pfizer sponsored program (FACILITATED COLLECT) received from contactable reporter (Consumer). The reporter is the patient. Other Case identifier(s): 21K-163-4166618-00.  A 62-year-old female patient received BNT162B2, subcutaneous, administration date 21Jul2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for COVID-19 immunisation; adalimumab, subcutaneous (Batch/Lot number: unknown) at 40 mg cyclic (1 in 2 wk) for moderate to severe rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 03Nov2021, outcome "not recovered" and all described as "COVID-19"; PNEUMONIA (medically significant) with onset 2021, outcome "unknown", described as "Pneumonia"; ELECTRIC SHOCK SENSATION described as "shocks in body", VERTIGO described as "Vertigo", HEADACHE described as "Headache" all (non-serious) with onset Aug2021, outcome "unknown"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "pressure in head"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Jul2021, described as "PFIZER BIONTECH COVID-19/Subcutaneous". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events Pneumonia, Drug ineffective, Suspected Covid19, Electric shock sensation, Vertigo, Head discomfort, Headache, Incorrect route of product administration and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Appendicitis
Clinical narrative: Stomach pain started 4 days after the 2nd vaccine shot. It was progressively getting worse, and we finally went in the ER on 12/7 where they diagnosed him with appendicitis, and scheduled him for surgery the next day on 12/8.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Nasal congestion, Oropharyngeal discomfort, Swelling face
Clinical narrative: whike sleeping I could hear my heartbeating fast . Could hear it  from my right ears as well. the T zone of my face was puffy,  Right nose, rirht throat was clugged and kind of dry. At about 2am I woke up when  i couldnt take it anymore. I called the    vaccination provider. also called /left a message on the toll number found on the fact sheet that was given to me .  Hope to vist the dr. in the morning.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Laboratory test
Clinical narrative: Extremely High blood pressure.
Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4167592-00. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 01Jan2021 (Batch/Lot number: unknown) at the age of 32 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till 2021 at citrate free for crohn's disease, rheumatoid arthritis. Relevant medical history included: "Moderate to severe Adult Crohn's Disease" (unspecified if ongoing); "Moderate to severe Rheumatoid Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13Nov2021, outcome " recovering", COVID-19 (medically significant) with onset 13Nov2021, outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was dosage permanently withdrawn on 2021. On 13Nov2021, the patient experienced COVID-19. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Jan2021, she received dose of COVID-19 Vaccine manufactured by Pfizer BioNTech.   Humira (Solution for injection in pre-filled pen) (Adalimumab): Causality:  Covid-19, Causality as per reporter (Drug/Vaccine): Not Related (also reported as not provided). Pfizer-BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran): Causality: Covid-19, Causality as per reporter (Drug/Vaccine): Possible.  The reporter's assessment of the causal relationship of the event drug ineffective with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; Have taken both covid shots and had booster 3 weeks ago/just tested positive; Have taken both covid shots and had booster 3 weeks ago/just tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Have taken both covid shots and had booster 3 weeks ago/just tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Investigation, Liver function test, Liver function test increased, Pyrexia, Renal impairment
Clinical narrative: elevated liver and kidney function; Elevated white blood count; fever; elevated liver and kidney function; Covid vaccine related issues; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4165037-00.  A 52-year-old female patient received BNT162B2 (BNT162B2), intramuscular, administration date 30Oct2021 (also reported as 31Oct2021) (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for Crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL IMPAIRMENT (medically significant), LIVER FUNCTION TEST INCREASED (non-serious) all with onset 2021, outcome "unknown" and all described as "elevated liver and kidney function"; WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Elevated white blood count"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; VACCINATION COMPLICATION (non-serious) with onset 2021, outcome "unknown", described as "Covid vaccine related issues". The patient underwent the following laboratory tests and procedures: investigation: (2021) elevated; liver function test: (2021) elevated/increased; white blood cell count: (2021) elevated/increased. The action taken for adalimumab was unknown. Causality of events to adalimumab was not reported. Causality of events by the reporter to BNT162B2 was probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. 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: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination complication, White blood cell count, White blood cell count increased
Clinical narrative: elevated liver and kidney function; Elevated white blood count; fever; elevated liver and kidney function; Covid vaccine related issues; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4165037-00.  A 52-year-old female patient received BNT162B2 (BNT162B2), intramuscular, administration date 30Oct2021 (also reported as 31Oct2021) (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for Crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL IMPAIRMENT (medically significant), LIVER FUNCTION TEST INCREASED (non-serious) all with onset 2021, outcome "unknown" and all described as "elevated liver and kidney function"; WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Elevated white blood count"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; VACCINATION COMPLICATION (non-serious) with onset 2021, outcome "unknown", described as "Covid vaccine related issues". The patient underwent the following laboratory tests and procedures: investigation: (2021) elevated; liver function test: (2021) elevated/increased; white blood cell count: (2021) elevated/increased. The action taken for adalimumab was unknown. Causality of events to adalimumab was not reported. Causality of events by the reporter to BNT162B2 was probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he's got a diagnosis and it's SARS; he's got a diagnosis and it's SARS; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he's got a diagnosis and it's SARS". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative; positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.  Clinical course: Reporter reported as one of his coworkers has been out sick and in isolation for like 2 weeks. He says he kept testing negative for Covid over and over again but was continually getting worse and had no idea what it was. He said that he's got a diagnosis and it's SARS.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Body temperature, COVID-19, Chills, Dyspnoea
Clinical narrative: Lack of efficacy COVID-19 infection confirmed through rapid test; Lack of efficacyCOVID-19 infection confirmed through rapid test and characterized by fever (100-101F), aches, pains, lack of smell, chills, shortness of breath; fever (100-101F); pain/aches; lack of smells; Chills; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10May2021 (Lot number: EW0173) at the age of 30 years as dose 2, single and intramuscular, administered in arm left, administration date 19Apr2021 (Lot number: EW0170) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 22Nov2021 17:00, outcome "recovering", described as "Lack of efficacy COVID-19 infection confirmed through rapid test"; COVID-19 (medically significant) with onset 22Nov2021 17:00, outcome "recovering", described as "Lack of efficacyCOVID-19 infection confirmed through rapid test and characterized by fever (100-101F), aches, pains, lack of smell, chills, shortness of breath"; PYREXIA (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "fever (100-101F)"; PAIN (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "pain/aches"; ANOSMIA (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "lack of smells"; CHILLS (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "Chills"; DYSPNOEA (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "shortness of breath". The events "lack of efficacy covid-19 infection confirmed through rapid test", "lack of efficacycovid-19 infection confirmed through rapid test and characterized by fever (100-101f), aches, pains, lack of smell, chills, shortness of breath", "fever (100-101f)", "pain/aches", "lack of smells", "chills" and "shortness of breath" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) result unknown, notes: (100-101F); sars-cov-2 test: (24Nov2021) positive, notes: Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pyrexia, pain, anosmia, chills, dyspnoea.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of efficacy COVID-19 infection confirmed through rapid test; Lack of efficacyCOVID-19 infection confirmed through rapid test and characterized by fever (100-101F), aches, pains, lack of smell, chills, shortness of breath; fever (100-101F); pain/aches; lack of smells; Chills; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10May2021 (Lot number: EW0173) at the age of 30 years as dose 2, single and intramuscular, administered in arm left, administration date 19Apr2021 (Lot number: EW0170) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 22Nov2021 17:00, outcome "recovering", described as "Lack of efficacy COVID-19 infection confirmed through rapid test"; COVID-19 (medically significant) with onset 22Nov2021 17:00, outcome "recovering", described as "Lack of efficacyCOVID-19 infection confirmed through rapid test and characterized by fever (100-101F), aches, pains, lack of smell, chills, shortness of breath"; PYREXIA (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "fever (100-101F)"; PAIN (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "pain/aches"; ANOSMIA (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "lack of smells"; CHILLS (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "Chills"; DYSPNOEA (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "shortness of breath". The events "lack of efficacy covid-19 infection confirmed through rapid test", "lack of efficacycovid-19 infection confirmed through rapid test and characterized by fever (100-101f), aches, pains, lack of smell, chills, shortness of breath", "fever (100-101f)", "pain/aches", "lack of smells", "chills" and "shortness of breath" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) result unknown, notes: (100-101F); sars-cov-2 test: (24Nov2021) positive, notes: Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pyrexia, pain, anosmia, chills, dyspnoea.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Suspected COVID-19
Clinical narrative: Individual was talking about (believed) her dad who has covid.; Individual was talking about (believed) her dad who has covid.; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "Individual was talking about (believed) her dad who has covid."; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "tired". The patient did not loose taste or smell but just tired. Caught it believe about a week ago. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation
Clinical narrative: just slept the day after; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (115193). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, dose number unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 19Nov2021, outcome "unknown", described as "just slept the day after".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pyrexia
Clinical narrative: COVID Booster; Fever; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4466102.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, dose number unknown.), for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID Booster"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "Chills".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, COVID-19, Drug ineffective, Lymphoedema, SARS-CoV-2 test
Clinical narrative: Graves' disease; lymphedema; she had a breakthrough covid case in September 2021; she had a breakthrough covid case in September 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Sep2021, outcome "unknown", COVID-19 (medically significant) with onset Sep2021, outcome "recovered" and all described as "she had a breakthrough covid case in September 2021"; BASEDOW'S DISEASE (hospitalization, medically significant) with onset Sep2021, outcome "unknown", described as "Graves' disease"; LYMPHOEDEMA (hospitalization) with onset Sep2021, outcome "unknown", described as "lymphedema". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Sep2021) positive. Additional information: Not sure which vaccine she had. Most of this information was gleaned from Prevention magazine. Will put 27Nov as awareness date since that is when first learned of hospitalization, though most other details learned 28Nov.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: family getting covid after vaccination; family getting covid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "family getting covid after vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. News Article regarding family getting covid after vaccination. The patient was tested positive for Covid-19 post vaccination.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Bloody noses, one required trip to ER because I was unable to stop the bleeding after 40 minutes. I have had multiple episodes since; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Nov2021 17:30 (Lot number: FH8028) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Gluten sensitivity" (unspecified if ongoing); "Known allergies: Tetracycline" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, administration date 26Oct2021. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EN5318, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 02Feb2021, for COVID-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: EL3302, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 12Jan2021, for COVID-19 Immunization. The following information was reported: EPISTAXIS (non-serious) with onset 20Nov2021 05:00, outcome "recovering", described as "Bloody noses, one required trip to ER because I was unable to stop the bleeding after 40 minutes. I have had multiple episodes since". The event "bloody noses, one required trip to er because i was unable to stop the bleeding after 40 minutes. i have had multiple episodes since" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of epistaxis.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Myalgia, Pain, Pain in extremity
Clinical narrative: less arm pain; pain on his hamstrings; swollen right hand; right shoulder pain; severe pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Sep2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for rheumatoid arthritis. The following information was reported: IMMUNISATION (non-serious) with onset 27Sep2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "less arm pain"; MYALGIA (non-serious), outcome "unknown", described as "pain on his hamstrings"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen right hand"; ARTHRALGIA (non-serious), outcome "unknown", described as "right shoulder pain"; PAIN (non-serious), outcome "not recovered", described as "severe pain".  Additional information: It was reported that prior to vaccination, patient was on neuro medication and had no issues before, he was very strong and can ride a bike in 10 miles once a week. Reporter stated that he spoke to his HCP and was prescribed with Meloxicam 75mg (generic) medication for Rheumatoid Arthritis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: less arm pain; pain on his hamstrings; swollen right hand; right shoulder pain; severe pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Sep2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for rheumatoid arthritis. The following information was reported: IMMUNISATION (non-serious) with onset 27Sep2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "less arm pain"; MYALGIA (non-serious), outcome "unknown", described as "pain on his hamstrings"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen right hand"; ARTHRALGIA (non-serious), outcome "unknown", described as "right shoulder pain"; PAIN (non-serious), outcome "not recovered", described as "severe pain".  Additional information: It was reported that prior to vaccination, patient was on neuro medication and had no issues before, he was very strong and can ride a bike in 10 miles once a week. Reporter stated that he spoke to his HCP and was prescribed with Meloxicam 75mg (generic) medication for Rheumatoid Arthritis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Ear pain, Nasal congestion, Pyrexia
Clinical narrative: temperature of 99.6 Fahrenheit; a cut body; rhinorrhea; congestion nasal; earache; This is a spontaneous report received from contactable reporter (consumer).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included: "COVID-19," start date: 2021, stop date: 2021, notes: She suffered from COVID-19, approximately 1-2 months prior reporting; although she was not hospitalized, she required oxygen support and had not been vaccinated prior to infection. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown," described as "temperature of 99.6 Fahrenheit;" DISCOMFORT (non-serious) with onset 2021, outcome "unknown," described as "a cut body;" RHINORRHOEA (non-serious) with onset 2021, outcome "unknown," described as "rhinorrhea;" NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown," described as "congestion nasal;" EAR PAIN (non-serious) with onset 2021, outcome "unknown," described as "earache." Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: One day after receiving the vaccine, the patient had a temperature of 99.6 Fahrenheit, a cut body (as reported), rhinorrhea, nasal congestion, and earache. This was the first and only dose of vaccine received. The events occurred after use of the product.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: temperature of 99.6 Fahrenheit; a cut body; rhinorrhea; congestion nasal; earache; This is a spontaneous report received from contactable reporter (consumer).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included: "COVID-19," start date: 2021, stop date: 2021, notes: She suffered from COVID-19, approximately 1-2 months prior reporting; although she was not hospitalized, she required oxygen support and had not been vaccinated prior to infection. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown," described as "temperature of 99.6 Fahrenheit;" DISCOMFORT (non-serious) with onset 2021, outcome "unknown," described as "a cut body;" RHINORRHOEA (non-serious) with onset 2021, outcome "unknown," described as "rhinorrhea;" NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown," described as "congestion nasal;" EAR PAIN (non-serious) with onset 2021, outcome "unknown," described as "earache." Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: One day after receiving the vaccine, the patient had a temperature of 99.6 Fahrenheit, a cut body (as reported), rhinorrhea, nasal congestion, and earache. This was the first and only dose of vaccine received. The events occurred after use of the product.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Apr2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and intramuscular, administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications (reported as multivitamins). Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Nov2021, outcome "recovered" and all described as "positive COVID-19 test with symptoms". The event "positive covid-19 test with symptoms" and "positive covid-19 test with symptoms" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) positive, notes: Nasal Swab. It was also reported that patient tested positive for COVID: body aches, fever, bad headache, sore throat, chills, fatigue, vomiting.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid after first dose; got covid after first dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 31Aug2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "got covid after first dose". Clinical course: The patient first dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) on 31Aug2021 and then developed COVID-19. Patient did not receive second dose of the vaccine and caller is asking if patient needs to restart the series.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Drooling, Multiple sclerosis, Oropharyngeal discomfort, Sickle cell disease
Clinical narrative: I have multiple sclerosis; Sickle cell; I am having problem with my throat like cold trying to come up; Drooling up from my mouth; My throat is bad and I keep drooling for no reason; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "I have multiple sclerosis"; OROPHARYNGEAL DISCOMFORT (non-serious) with onset Nov2021, outcome "unknown", described as "I am having problem with my throat like cold trying to come up"; DROOLING (non-serious) with onset Nov2021, outcome "unknown", described as "Drooling up from my mouth; My throat is bad and I keep drooling for no reason"; SICKLE CELL DISEASE (non-serious), outcome "unknown", described as "Sickle cell".  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antiphospholipid antibodies, Bone tuberculosis, Chillblains, Feeling abnormal, Small fibre neuropathy
Clinical narrative: Pott's; chilblain on fingers; small fiber neuropathy on hands; brain fogs; Patient developed anti-phospholipid antibody with no clotting; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. A 37 year-old female patient received bnt162b2 (COMIRNATY), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE TUBERCULOSIS (medically significant), outcome "unknown", described as "Pott's"; CHILLBLAINS (non-serious), outcome "unknown", described as "chilblain on fingers"; SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "small fiber neuropathy on hands"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fogs"; ANTIPHOSPHOLIPID ANTIBODIES (non-serious), outcome "unknown", described as "Patient developed anti-phospholipid antibody with no clotting".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 29Nov2021 covid test result=Positive; 29Nov2021 covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 (Lot number: EW0217) at the age of 20 years as dose 3 (booster), single, administered in arm left, administration date 07May2021 (Lot number: ER8736) as dose 2, single and administered in arm left, administration date 15Apr2021 (Lot number: ER8729) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Bactrum, reaction(s): "Allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Nov2021, outcome "unknown" and all described as "29Nov2021 covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive, notes: covid test type post vaccination=Nasal Swab.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Immunisation, SARS-CoV-2 test
Clinical narrative: 29Nov2021 covid test result=Positive; 29Nov2021 covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 (Lot number: EW0217) at the age of 20 years as dose 3 (booster), single, administered in arm left, administration date 07May2021 (Lot number: ER8736) as dose 2, single and administered in arm left, administration date 15Apr2021 (Lot number: ER8729) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Bactrum, reaction(s): "Allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Nov2021, outcome "unknown" and all described as "29Nov2021 covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive, notes: covid test type post vaccination=Nasal Swab.