chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4435587-00 (Agency).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 06May2021 as dose 1, single (Batch/Lot number: unknown), on 27May2021 as dose 2, single (Batch/Lot number: unknown) and on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (ongoing) (Batch/Lot number: unknown) subcutaneous for psoriasis. The patient's relevant medical history included: "Bypass surgery", start date: 09Feb2021 (unspecified if ongoing), notes: Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant) with onset May2022, outcome "unknown". The action taken for risankizumab was dosage not changed.  Causality: The reporter's causality for the event (s) of pneumonia for skyrizi (risankizumab) was not provided. Agency's opinion is that there is a reasonable possibility that the event of pneumonia is related to skyrizi (risankizumab).   The reporter's assessment of the causal relationship of "pneumonia" with the suspect product(s) BNT162b2 was not related.  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 information available, the causal relationship between the reported event and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Immunisation reaction, Neuropathy peripheral
Clinical narrative: Neuropathy in feet; Feeling tired; ended up in emergency room with Pfizer booster vaccine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4426123-00 (Agency).  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160837), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "Neuropathy in feet"; FATIGUE (non-serious), outcome "not recovered", described as "Feeling tired"; IMMUNISATION REACTION (non-serious), outcome "unknown", described as "ended up in emergency room with Pfizer booster vaccine". The event "ended up in emergency room with pfizer booster vaccine" required emergency room visit. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "neuropathy in feet" and "feeling tired" with the suspect product(s) 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 reporter considered "ended up in emergency room with pfizer booster vaccine" related to BNT162b2. The reporters causality for the event (s) of feeling tired, ended up in emergency room with Pfizer booster vaccine and neuropathy in feet with the suspect product Humira was not reported.  Clinical course: Solicited report from a consumer of an elderly female with events of non-serious feeling tired, ended up in emergency room with Pfizer booster vaccine and neuropathy in feet with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced feeling tired, ended up in emergency room with Pfizer booster vaccine and neuropathy in feet. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect.  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 information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, Pneumonia fungal, Vaccination site papule, Vaccination site rash
Clinical narrative: Fungal infection in the Lungs; Rash and raised reaction at the site of Pfizer booster; Vaccination site papule; Inflammation with joint; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4434822-00 (Agency).  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for 1 day intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) and second regimen (Batch/Lot number: unknown) at unk (citrate free), all subcutaneous for crohn's disease. The patient's relevant medical history included: "Pulmonary illness" (unspecified if ongoing), notes: Pulmonary illness. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series: Unknown, Intramuscular), for COVID-19 Immunization. The following information was reported: PNEUMONIA FUNGAL (medically significant), outcome "recovered", described as "Fungal infection in the Lungs"; VACCINATION SITE RASH (non-serious), outcome "recovered", described as "Rash and raised reaction at the site of Pfizer booster"; VACCINATION SITE PAPULE (non-serious), outcome "recovered"; ARTHRITIS (non-serious), outcome "recovering", described as "Inflammation with joint". The action taken for adalimumab was temporarily withdrawn.  The reporter's assessment of the causal relationship of "fungal infection in the lungs" and "inflammation with joint" with the suspect product(s) 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 reporter considered "rash and raised reaction at the site of pfizer booster" and "vaccination site papule" related to BNT162b2.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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.
Sex: U
Vaccine: COVID19
Symptoms: Hormone level abnormal, Investigation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HORMONE LEVEL ABNORMAL (non-serious), outcome "unknown", described as "Covid vaccine has screwed up my hormones". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Case Category: Patient Assistance Programs.  The patient reported to Pfizer.com Description of Inquiry: Have you figured out why your Covid vaccine has screwed up my hormones yet because its annoying. CEP Number: CEP 005570. The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US071662. A 64-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "he got the covid booster and it 'knocked me out for a few days.". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: had post menopausal bleeding for a few days after first booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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, unknown manufacturer), for COVID-19 Immunization.  The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 21Jun2022, outcome "unknown", described as "had post menopausal bleeding for a few days after first booster".  Clinical course: I had post menopausal bleeding for a few days after first booster. I'm worried about getting second booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: a grey cap vaccine was taken out and left at room temperature  for 25.5 hours and then administered to patient; a grey cap vaccine was taken out and left at room temperature  for 25.5 hours and then administered to patient; This is a spontaneous report received from a contactable reporter pharmacist from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FN2908, Expiration Date: 12Aug2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "a grey cap vaccine was taken out and left at room temperature for 25.5 hours and then administered to patient".  Additional information:-The product was undiluted. the product stored outside of fridge when excursion occurred. temperature reported/measured during excursion, maximum temperature was 74-degree F (23 degree C) and minimum temperature was 68 degree F (20 degree C) and it was left out at room temperature for 25.5 hrs after punctured and was administered to patient and reporter wants to know if patient needs to be re-vaccinated. Vials kept in fridge prior to taken out at 2-8 degree C.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4399802-00.  A 19-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), on 12May2021 as dose 2, single (Batch/Lot number: unknown) and on 14Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 18 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Moderate to severe hidradenitis suppurativa" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA subcutaneous taken for hidradenitis. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID-19".  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event COVID 19 cannot be excluded based on temporal association and available information.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colon operation, Somnolence, Vomiting
Clinical narrative: Colon operation; Sleepy; Vomited; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4438481-00 (Agency).  A 44-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number unknown. , Primary Immunization series complete but unknown manufacturer.), for COVID-19 Immunization. The following information was reported: COLON OPERATION (medically significant), outcome "unknown"; SOMNOLENCE (non-serious), outcome "unknown", described as "Sleepy"; VOMITING (non-serious), outcome "unknown", described as "Vomited". The action taken for adalimumab was unknown.  Clinical course: Reporter also reported as an adult female with events of Colon surgery and non-serious sleepy after Covid Vaccine/slept 15 hours and Vomited after Covid booster with humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced colon surgery, sleepy after covid vaccine/slept 15 hours and vomited after covid booster.   Causality assessment: The reporter's assessment of the causal relationship of "colon operation", "sleepy" and "vomited" with the suspect product(s) 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 reporter causality for the event(s) of colon surgery with humira (Adalimumab was no reasonable possibility) Not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.; Sender's Comments: Based on available information and known profile of the Comirnaty vaccine  ,the reported events of sleepy and vomited  were assessed as related to the  Comirnaty vaccine. Based on the information provided by the reporter, it appears unlikely that suspect drug contributed to the reported  event colon operation.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Contusion, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA199767. A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization, immunization; dupilumab (DUPIXENT), (Batch/Lot number: unknown) at single (dose number unknown, single). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), CONTUSION (non-serious), outcome "unknown" and all described as "sore arm which bruised". The action taken for dupilumab was unknown. Additional information: The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking Dupixent injection (with an unknown strength dose, frequency, route, lot/batch number and expiration date) and Tozinameran (with an unknown strength dose, frequency, route, lot/batch number and expiration date) for Prophylactic vaccination. Information on lot number was requested. On an unknown date (Unknown latency), the patient had a non-serious "sore arm which bruised" (Pain in extremity) and (contusion) respectively with intake of Dupixent and Tozinameran. It was reported "Pfizer booster: sore arm which bruised Description: My way nurse transferred consumer who asks for timing of second Pfizer booster and DUPIXENT injection. It is unknown if the patient experienced any additional symptoms/events. Unknown It is unknown if the patient had any concomitant disease or risk factor. It is unknown if there were lab data/results available". Action taken with Dupixent was unknown and not applicable with Tozinameran. It was not reported if the patient received a corrective for the events. At time of reporting, the outcome was unknown for the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive with Covid 19 after vaccination.; Patient tested positive with Covid 19 after vaccination.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient in his 30's received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) 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 "Patient tested positive with Covid 19 after vaccination.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Patient tested positive with Covid 19 after vaccination. Clinical course: Patient was vaccinated with Comirnaty and subsequently contracted COVID 19. Patient is male, mid-30s, height and weight unknown. DOB unknown. Patient tested positive with COVID-19 after vaccination. Symptoms mild.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes under armpit after receiving their booster dose; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 7-year-old patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number unknown. Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes under armpit after receiving their booster dose".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I received both base Pfizer covid vaccines and a Pfizer booster shot. I contracted covid last week and am currently infected; I received both base Pfizer covid vaccines and a Pfizer booster shot. I contracted covid last week and am currently infected; 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), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jun2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I received both base Pfizer covid vaccines and a Pfizer booster shot. I contracted covid last week and am currently infected". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Haemoptysis, Headache, Illness
Clinical narrative: got covid probably omicron 2.1 with 2 pfizer and booster; got covid probably omicron 2.1 with 2 pfizer and booster; I was so sick my world imploded; coughing up blood; severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovered" and all described as "got covid probably omicron 2.1 with 2 pfizer and booster"; ILLNESS (non-serious), outcome "recovered", described as "I was so sick my world imploded"; HAEMOPTYSIS (non-serious), outcome "recovered", described as "coughing up blood"; HEADACHE (non-serious), outcome "recovered", described as "severe headache". The events "got covid probably omicron 2.1 with 2 pfizer and booster", "i was so sick my world imploded", "coughing up blood" and "severe headache" required emergency room visit. Therapeutic measures were taken as a result of covid-19, drug ineffective, illness, haemoptysis, headache.  Clinical course: Patient got covid probably omicron 2.1 with 2 pfizer and booster. In one day patient was so sick patient world imploded. patient was coughing up blood severe headache no idea what was going on. Went to ER and got paxlovid and nebulizer. In 12 hours patient felt a little better. 24 almost better and day 3 almost symptom free. This was the best thing ever. Thank you1,000,000 times over as patient really thought it was over. So much for a mild disease.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective
Clinical narrative: Pfizer COVID Vaccine/ reports pneumonia diagnosed Dec2021 and concerns for new COVID variantS; Pfizer COVID Vaccine/ reports pneumonia diagnosed Dec2021 and concerns for new COVID variantS; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID:.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Pneumonia", start date: Dec2021 (unspecified if ongoing), notes: Pneumonia Previously Reported 05Jan2022/Reported Pneumonia diagnosed Dec2021. The patient's concomitant medications were not reported. The following information was reported: COVID-19 PNEUMONIA (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Pfizer COVID Vaccine/ reports pneumonia diagnosed Dec2021 and concerns for new COVID variantS".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid19 Pneumonia, drug ineffective.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood cholesterol, Blood cholesterol increased, Diabetes mellitus, Heart rate increased
Clinical narrative: diabetes; weight loss; stomach cramping; trouble sleeping; high cholesterol; fast heart beat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02186127 (Agency).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "weight loss"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach cramping"; SLEEP DISORDER (non-serious), outcome "unknown", described as "trouble sleeping"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "high cholesterol"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart beat". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high; Heart rate increased: Increased.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Weight decreased
Clinical narrative: diabetes; weight loss; stomach cramping; trouble sleeping; high cholesterol; fast heart beat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02186127 (Agency).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "weight loss"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach cramping"; SLEEP DISORDER (non-serious), outcome "unknown", described as "trouble sleeping"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "high cholesterol"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart beat". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high; Heart rate increased: Increased.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: wife had pfizer vaccine/ she became sick with covid 2 weeks ago; wife had pfizer vaccine/ she became sick with covid 2 weeks ago; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) 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 "wife had pfizer vaccine/ she became sick with covid 2 weeks ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Covid, notes: She became sick with covid 2 weeks ago.  Clinical information: Friends of reporter, wife had Pfizer vaccine and her husband Moderna. She became sick with covid 2 weeks ago.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got positive for covid-19; got positive for covid-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 21Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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 22Jun2022, outcome "unknown" and all described as "got positive for covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Positive, notes: got positive for covid-19 today (22Jun2022).  Additional information: A Pharmacist called in and said they have a patient who got their Pfizer booster shot yesterday and got positive for covid-19 today (22Jun2022). Now they are asking if that was the booster Shot or if they really have a covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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 cannot be excluded. The case will be reassessed once new information is available.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Dizziness, Fatigue, Full blood count, Heavy menstrual bleeding
Clinical narrative: Dizziness immediately after injection.  Severe flu-like symptoms including extreme fatigue for 2 weeks following injection, missed 2 days of work.   Menstrual cycle started early the month after shot (I was ovulating at the time of second shot) then NO ovulation for 6 months following shot series.  I am now anemic to point of required prescription iron medication due to heavy periods after cycle resumed.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Impaired work ability, Influenza like illness, Metabolic function test, Polymenorrhoea
Clinical narrative: Dizziness immediately after injection.  Severe flu-like symptoms including extreme fatigue for 2 weeks following injection, missed 2 days of work.   Menstrual cycle started early the month after shot (I was ovulating at the time of second shot) then NO ovulation for 6 months following shot series.  I am now anemic to point of required prescription iron medication due to heavy periods after cycle resumed.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound pelvis
Clinical narrative: Dizziness immediately after injection.  Severe flu-like symptoms including extreme fatigue for 2 weeks following injection, missed 2 days of work.   Menstrual cycle started early the month after shot (I was ovulating at the time of second shot) then NO ovulation for 6 months following shot series.  I am now anemic to point of required prescription iron medication due to heavy periods after cycle resumed.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Apraxia, Cerebral haemorrhage, Computerised tomogram head abnormal, Endotracheal intubation
Clinical narrative: 6/20/2022  Presented to Hospital after being found down by family in the bathroom with left gaze, mute, and right sided weakness.  Intubated.  CT head showed Left MCA syndrome. Transferred to another Hospital for thrombectomy.  Post thrombectomy with Tici 3 reperfusion.   6/21 Repeat Head CT: stable.   Lasix given x1 dose.   6/22 Repeat Head CT inclusive.  (not sure if bleed vs contrast).  No cuff leak - started on solumedrol  6/23 MRI head: small amount of petechial hemorrhage 6/24:  Still intubated.  Awaiting extubation.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hemiparesis, Magnetic resonance imaging head abnormal, Mast cell activation syndrome, Thrombectomy
Clinical narrative: 6/20/2022  Presented to Hospital after being found down by family in the bathroom with left gaze, mute, and right sided weakness.  Intubated.  CT head showed Left MCA syndrome. Transferred to another Hospital for thrombectomy.  Post thrombectomy with Tici 3 reperfusion.   6/21 Repeat Head CT: stable.   Lasix given x1 dose.   6/22 Repeat Head CT inclusive.  (not sure if bleed vs contrast).  No cuff leak - started on solumedrol  6/23 MRI head: small amount of petechial hemorrhage 6/24:  Still intubated.  Awaiting extubation.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye irritation, Periorbital swelling, Swelling
Clinical narrative: Severe swelling, puffiness, redness, and irritation of both eyes.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram head abnormal, Conjunctival haemorrhage, Facial bones fracture, Intraventricular haemorrhage
Clinical narrative: Patient presented to Ra local Hospital via EMS after being found down in bathroom at Skilled Nursing Facility. Coumadin reversed with Vitamin K and FFP.  CT head 6/24 showed Subarachnoid Hemorrhage in bilateral frontal lobes and right parietal lobe.  He also had left eye conjunctival hemorrhage, suborbital hematoma and orbital wall fracture.   6/24: Head CT: showed new intraventricular hemorrhage. 6/24:  repeat Head CT in evening was stable.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Periorbital haematoma, Subarachnoid haemorrhage
Clinical narrative: Patient presented to Ra local Hospital via EMS after being found down in bathroom at Skilled Nursing Facility. Coumadin reversed with Vitamin K and FFP.  CT head 6/24 showed Subarachnoid Hemorrhage in bilateral frontal lobes and right parietal lobe.  He also had left eye conjunctival hemorrhage, suborbital hematoma and orbital wall fracture.   6/24: Head CT: showed new intraventricular hemorrhage. 6/24:  repeat Head CT in evening was stable.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, No adverse event, Wrong technique in product usage process
Clinical narrative: I am reporting this as an error in administration of the vaccine. The patient did not experience any symptomatic adverse reaction. My child received the vaccine and then we left the office. About 15 minutes later I received a phone call from the doctor's office asking that I come back because there had been a mistake in dosage. The nurse told me that she had accidentally given a lower dose than prescribed and that my child needed a second dose. My child has not experienced any adverse symptoms as a result of this error but it was very inconvenient and caused my child unnecessary anxiety by having to go back for a second shot.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Itching started on my belly. It goes deep into the muscles. It spread to my entire abdomen and has been HORRIBLE for 60 HOURS now!!! After 36 hours of itching, I developed a fine pink rash on my abdomen! WISH I'D NEVER RECEIVED THE STUPID VACCINES!!!
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, No adverse event, Product administration error, Underdose
Clinical narrative: I am reporting this as an error in administration of the vaccine. My child did not experience any adverse symptoms due to this error. My child received the vaccine and then we left the office. About 15 minutes later I received a phone call from the nurse asking use to come back because there was an accidental error in the dosage that was administered. The nurse told me that my child had accidentally received a lower dose than prescribed and we had to come back to get a 2nd dose. Although my child did not experience any adverse symptoms due to this error, it was inconvenient and my child experienced unnecessary anxiety by having to go back for a 2nd shot.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever of 101, chills, aches
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: injected left arm Pt moved no vaccine administered .wasted the vaccine administered the new vaccine on the right arm.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling cold, Muscle spasms, Pain
Clinical narrative: I woke up at 1:00 am , several hours after getting the shot. My body was freezing with chills coupled with  painful cramps throughout my body. i couldn't stop shaking with chills until my wife piled on several blankets, which warmed me up. The chills and the cramps went away after a 1/2 hour or so. Felt wiped out the next morning and throughout the day. Same exact adverse effect occurred on the following days when i got the next three shots: 3/21/2021 11/01/2021 06/23/2022
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I woke up at 1:00 am , several hours after getting the shot. My body was freezing with chills coupled with  painful cramps throughout my body. i couldn't stop shaking with chills until my wife piled on several blankets, which warmed me up. The chills and the cramps went away after a 1/2 hour or so. Felt wiped out the next morning and throughout the day. Same exact adverse effect occurred on the following days when i got the next three shots: 3/21/2021 11/01/2021 06/23/2022
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder, Delusion, Hallucination
Clinical narrative: Delusions starting on 10/28/2021, Hallucinations starting a few days later. Pt already had Mild Cognitive Impairment that began several years earlier.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity, Varicose vein, Vein discolouration
Clinical narrative: Sore soles of feet. Difficulty walking. Veins on arms and hands bulging, dark in color, painful.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Trismus
Clinical narrative: On June 25th, 2022, Saturday at approximately 09:19am, patient was vaccinated with Pfizer Pediatric  0.20 ml I/M Left Arm.  Patient was then directed to Observation.  After a few minutes in Observation, it was reported to me that pt. was experiancing "Facial Muscle Spasms of the Mouth & Lips also causing an Involuntary Opening of the Lower Jaw" every few minutes.  Vital Signs were taken: HR 103; SpO2: 99RA; BP; 118/88; COAx4.  There were no life threating issues.  Pt remained in direct observation until 09:50am.  mother of patient informed me that she was bringing her daughter to a local Medical Center,  to see her Primary Care Physician.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Parkinson's disease, Periarthritis, Tremor
Clinical narrative: Within three weeks of having the Moderna Covid 19 vaccine the patient had a very stiff right shoulder.  She went to the doctor and the doctor diagnosed her with a frozen shoulder and had her do physical therapy for several weeks.  Later in the year, the frozen shoulder returned and in October (8 months after the injection) patient began to have a tremor in the same arm.  She was diagnosed with Parkinson's in June 2022, 9 months after the tremor began.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Tinnitus started 24 hrs after,  persists a month after.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: SEVERE PAIN AT INJECTION SITE - PATIENT STATED TOO PAINFUL TO MOVE ARM UP
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Pt reported severe left leg pain.  She also had point tenderness in left thigh that worsened with sitting.  This occurred the night she received the vaccine but self resolved.  She had pain with her second injection the following month, but it was not as bad
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fluorescence angiogram, Imaging procedure, Laboratory test, Magnetic resonance imaging head, Visual field defect
Clinical narrative: Permanent scotoma of right eye involving central area of vision field
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Laboratory test, Myocarditis, Troponin increased
Clinical narrative: Patient presented with increasing chest pain and elevated troponin two days following third dose of Pfizer vaccine.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide increased, Chest pain, Echocardiogram, Electrocardiogram, Immunoglobulin therapy
Clinical narrative: Patient presented with increasing chest pain and elevated troponin two days following third dose of Pfizer vaccine.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial necrosis marker increased, Nausea, Troponin increased
Clinical narrative: Patient presented with increasing chest pain and elevated troponin two days following third dose of Pfizer vaccine.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood blister, COVID-19, Chest pain, Contusion, Discharge
Clinical narrative: Within 15 minutes, hives and blood blisters from left shoulder to my wrist, and bruising around the left rotator cuff. Vomiting one hour later. Chest and arm numbness three hours later, lasting 2 weeks. Migraine six hours later (lasted 48 hours.) Kidney pain and bleeding 18 hours later, which has never subsided. Overactive bladder. Tested positive for Covid 5 days later. Chest pains 14 days later, which still occur. Muscular pains in limbs and torso approximately 21 days later, which have never subsided. Pain in injection site at unpredictable intervals, up to present time, worse than initial pain of injection. Kidney damage and muscular pains are potentially permanent, as they have continued unabated for 9 months. Note that the positive Covd test was immediately after the vaccine. I had never had tested positive for covid before, and I had no symptoms of covid prior to the vaccine. None of other adverse effects had occurred at any point in this life prior to the vaccine, except for one migraine in 2005 (not associated with any particular event or activity). I have no other prior history of migraines, chest pains, heart disease, neuropathy, kidney disorders, muscular pains, hives, etc. The kidney pain has been continuous with a constant moderate pain and acute spasms of higher-intensity pain. Concurrent to this I have been experiencing overactive bladder symptoms to the point of dry incontinence. A urinalysis conducted on 1 June 2022 showed turbid appearance, occult blood of 3+, RBC of 20-40, and trace protein levels. I also had two breakouts of subcutaneous swellings or pustules in the left armpit, one of which surfaced, ruptured and drained, the other of which never surfaced and which subsided. This is also something that never occurred before the vaccine.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Haematuria, Haemorrhage, Hypertonic bladder, Hypoaesthesia, Incontinence
Clinical narrative: Within 15 minutes, hives and blood blisters from left shoulder to my wrist, and bruising around the left rotator cuff. Vomiting one hour later. Chest and arm numbness three hours later, lasting 2 weeks. Migraine six hours later (lasted 48 hours.) Kidney pain and bleeding 18 hours later, which has never subsided. Overactive bladder. Tested positive for Covid 5 days later. Chest pains 14 days later, which still occur. Muscular pains in limbs and torso approximately 21 days later, which have never subsided. Pain in injection site at unpredictable intervals, up to present time, worse than initial pain of injection. Kidney damage and muscular pains are potentially permanent, as they have continued unabated for 9 months. Note that the positive Covd test was immediately after the vaccine. I had never had tested positive for covid before, and I had no symptoms of covid prior to the vaccine. None of other adverse effects had occurred at any point in this life prior to the vaccine, except for one migraine in 2005 (not associated with any particular event or activity). I have no other prior history of migraines, chest pains, heart disease, neuropathy, kidney disorders, muscular pains, hives, etc. The kidney pain has been continuous with a constant moderate pain and acute spasms of higher-intensity pain. Concurrent to this I have been experiencing overactive bladder symptoms to the point of dry incontinence. A urinalysis conducted on 1 June 2022 showed turbid appearance, occult blood of 3+, RBC of 20-40, and trace protein levels. I also had two breakouts of subcutaneous swellings or pustules in the left armpit, one of which surfaced, ruptured and drained, the other of which never surfaced and which subsided. This is also something that never occurred before the vaccine.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Migraine, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Within 15 minutes, hives and blood blisters from left shoulder to my wrist, and bruising around the left rotator cuff. Vomiting one hour later. Chest and arm numbness three hours later, lasting 2 weeks. Migraine six hours later (lasted 48 hours.) Kidney pain and bleeding 18 hours later, which has never subsided. Overactive bladder. Tested positive for Covid 5 days later. Chest pains 14 days later, which still occur. Muscular pains in limbs and torso approximately 21 days later, which have never subsided. Pain in injection site at unpredictable intervals, up to present time, worse than initial pain of injection. Kidney damage and muscular pains are potentially permanent, as they have continued unabated for 9 months. Note that the positive Covd test was immediately after the vaccine. I had never had tested positive for covid before, and I had no symptoms of covid prior to the vaccine. None of other adverse effects had occurred at any point in this life prior to the vaccine, except for one migraine in 2005 (not associated with any particular event or activity). I have no other prior history of migraines, chest pains, heart disease, neuropathy, kidney disorders, muscular pains, hives, etc. The kidney pain has been continuous with a constant moderate pain and acute spasms of higher-intensity pain. Concurrent to this I have been experiencing overactive bladder symptoms to the point of dry incontinence. A urinalysis conducted on 1 June 2022 showed turbid appearance, occult blood of 3+, RBC of 20-40, and trace protein levels. I also had two breakouts of subcutaneous swellings or pustules in the left armpit, one of which surfaced, ruptured and drained, the other of which never surfaced and which subsided. This is also something that never occurred before the vaccine.