chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: Tested positive for covid; Tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "t1 diabets" (unspecified if ongoing); "shellfish" (unspecified if ongoing); "penicillin" (unspecified if ongoing). Concomitant medication(s) included: INSULIN. Past drug history included: Augmentin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose number=2, Product=COVID 19, Brand=Pfizer, Lot unknown=True, Lot unknown reason=Other, Lot unknown reason other=dont have card, Administrator route=Intra muscular, Administration date=Mar2021, Vaccine location=Left arm), administration date: 2021, for Covid-19 immunization; Bnt162b2 (Dose number=1, Product=COVID 19, Brand=Pfizer, Lot unknown=True, Lot unknown reason=Other, Lot unknown reason other=dont have card, Administrator route=Intra muscular, Administration date= Apr2021, Vaccine location=Left arm), administration date: 2021, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Mar2022, outcome "unknown" and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: sars-cov-1 test: (01Mar2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course- Facility where the most recent COVID-19 vaccine was administered was Public Health/Military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was insulin medications the patient received within 2 weeks of vaccination. Since the vaccination the patient tested for COVID-19. The patient did not received any treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid 19 disease; tested positive for Covid 19 disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 (Batch/Lot number: unknown) at the age of 71 years 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. Relevant medical history included: "Psoriasis" (ongoing). Concomitant medication(s) included: COSENTYX taken for psoriasis (ongoing). Vaccination history included: Flu vaccine, administration date: Oct2021, when the patient was 71 years old, for immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "recovered" (13Jan2022) and all described as "tested positive for Covid 19 disease". The event "tested positive for covid 19 disease" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (01Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Severe chest pain on the left chest area; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2022 13:00 (Lot number: FM0698) at the age of 40 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Thalassaemia minor" (unspecified if ongoing), notes: Other medical history: Thalassemia minor; "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish, mango and mango tree sap; "Known allergies: mango and mango tree sap" (unspecified if ongoing), notes: Known allergies: Shellfish, mango and mango tree sap. Concomitant medication(s) included: CLARITIN ALLERGIC. The following information was reported: CHEST PAIN (non-serious) with onset 01Mar2022 16:00, outcome "unknown", described as "Severe chest pain on the left chest area". Therapeutic measures were not taken as a result of chest pain.  Additional information: Patient had no covid prior vaccination and covid was not tested post vaccination.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19 pneumonia, Drug ineffective, Drug interaction
Clinical narrative: COVID-19 pneumonia; COVID-19 pneumonia; The Rinvoq kept the patient from getting immunity from Covid vaccines; 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): 22K-163-4294615-00.  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 PNEUMONIA (hospitalization, medically significant), outcome "recovering", DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown" and all described as "COVID-19 pneumonia"; DRUG INTERACTION (non-serious), outcome "unknown", described as "The Rinvoq kept the patient from getting immunity from Covid vaccines". The patient was hospitalized for covid-19 pneumonia, drug ineffective (hospitalization duration: 11 day(s)). The action taken for upadacitinib was dosage not changed. Therapeutic measures were taken as a result of covid-19 pneumonia.  Causality: COVID-19 pneumonia (COVID-19 pneumonia), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Reasonable possibility, Dechallenge: N/A   Causality: COVID-19 pneumonia (COVID-19 pneumonia), Action(s) taken with drug: Dose Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A  The reporter's assessment of the causal relationship of the (COVID-19 pneumonia and The Rinvoq kept the patient from getting immunity from Covid vaccines) 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.  Clinical course information: The patient's daughter reported that the Rinvoq kept the patient from getting immunity from Covid vaccines and that he was admitted to the hospital for 11 days due to Covid pneumonia. In 2022, he was on supplemental oxygen. Stated that she was fairly certain that the patient had been taking Rinvoq as of 25Feb2022. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events and Drug Interaction.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Colitis ulcerative, Malaise
Clinical narrative: 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): 22K-163-4295026-00 (RA). A 15 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jun2021 (Batch/Lot number: unknown) at the age of 15 years as dose 2, single and intramuscular, administration date 20Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free (1 in 1 wk.) and second regimen subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free (1 in 2 wk.) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Route of Admin: Intra-muscular), administration date: 20May2021, when the patient was 15 years old, for Covid-19 Immunization. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset Dec2021, outcome "not recovered", described as "Ulcerative colitis flare up"; MALAISE (non-serious) with onset 2022, outcome "unknown", described as "Felt ill". The action taken for adalimumab was dosage not changed. Clinical course: In Dec2021, the patient experienced ulcerative colitis flare up. In 2022, the patient experienced felt ill. Pfizer BioNTech Covid-19 vaccine (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of ulcerative colitis flare up with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of felt ill with HUMIRA(ADALIMUMAB) was no reasonable possibility. 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 a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of ulcerative colitis flare up. 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza like illness, Psoriasis, Vaccination site pain
Clinical narrative: Injection site pain; Psoriasis flare-up; Flu like symptoms; 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): 22K-163-4291897-00 (Company).  A 43 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01May2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single and intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown) at unk- disco for psoriasis; risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", COVID-19 (medically significant) with onset 2021, outcome "recovered" (2021) and all described as "COVID-19"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Injection site pain"; PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare-up"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu like symptoms". The action taken for risankizumab and risankizumab rzaa was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of Skyrizi pen causes soreness, seasonal plaque psoriasis flair ups  in private areas where perspires, covid and flu like symptoms was not reported.  The reporter's causality for the event(s) of Skyrizi pen causes soreness, seasonal plaque psoriasis flair ups in private areas where perspires, covid and flu like symptoms was not reported. The reporter's causality for the event(s) of bnt162b2 (BNT162B2), causes soreness, seasonal plaque psoriasis flair ups in private areas where perspires was not reported, covid and flu like symptoms was reported as possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Child who is 8 yr got COVID after father got covid from offsite dinner event/covid test result: Positive; Child who is 8 yr got COVID after father got covid from offsite dinner event/covid test result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (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: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset 24Feb2022, outcome "unknown" and all described as "Child who is 8 yr got COVID after father got covid from offsite dinner event/covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Feb2022) positive, notes: covid test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown whether the patient tested positive for Covid-19 prior to vaccination and she was tested positive for Covid post vaccination.  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 provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Drug ineffective, COVID-19 cannot be completely excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Menopause
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2021 16:00 (Lot number: EL3246) at the age of 47 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Niacin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (DOSE 1, Batch/Lot No: EK5730, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 23Dec2020, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "complete loss of menses". The following information was reported: DRUG HYPERSENSITIVITY (disability) with onset 16Jan2021, outcome "not recovered", described as "severe allergic reaction"; MENOPAUSE (disability) with onset 16Jan2021, outcome "not recovered", described as "complete loss of menses". Therapeutic measures were not taken as a result of drug hypersensitivity, menopause. Clinical information: The patient reported complete loss of menses to date with NO previous signs of menopause. No other medications were taken in two weeks. No other vaccine was taken in four weeks. No Covid prior vaccination. No Covid tested post vaccination. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the Drug hypersensitivity 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: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pulmonary embolism
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 27 year-old male patient received bnt162b2 (BNT162B2), administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (medically significant) with onset Oct2021, outcome "recovering", described as "Pulmonary embolism"; MIGRAINE (non-serious) with onset 01Oct2021, outcome "recovering", described as "New daily persistent headache, with migrainous features beginning on day of vaccination". The events "pulmonary embolism" and "new daily persistent headache, with migrainous features beginning on day of vaccination" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism, migraine. The treatment received for the adverse event included anticoagulation and headache medication. Clinical Course: The patient had no known allergies. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the Pulmonary embolism 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
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and administration date 25Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Sep2021 (Lot number: Ew0217) at the age of 34 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PANTOPRAZOLE; CETIRIZINE. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot no: EW0187), administration date: 12Aug2021, for COVID-19 immunization. The following information was reported: HAEMORRHAGE (medically significant) with onset 24Feb2022, outcome "not recovered", described as "Bleeding 2 weeks after my last period". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Feb2022) negative, notes: Covid test name post vaccination Saliva. Therapeutic measures were not taken as a result of haemorrhage. Clinical course: I have been on birth control for 15 years with very regular periods, rare spotting in between periods on continuous method after no period for 3+ months. I am bleeding 2 weeks after my last period. Still on birth control and have always taken regularly with no problems in 15 years. Additional information: Patient was not received any other vaccine four weeks prior vaccination. Patient tested for COVID-19 after vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Birth control, Pantoprazole, Cetirizine. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the Haemorrhage 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Blood pressure measurement, Chest pain, Cough
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 12:00 (Lot number: 33025BD) at the age of 20 years as dose 2 (booster), single for Covid-19 immunisation. Relevant medical history included: "Johnson & Johnson Dose Number: 1", start date: 20Jan2022 (unspecified if ongoing), notes: Verbatim: Johnson & Johnson Dose Number: 1. The patient's concomitant medications were not reported. Vaccination history included: Johnson & Johnson (Dose Number: 1, Batch/Lot No: 201A21A, Location of injection: Arm Left, Vaccine Administration Time: 03:45 PM), administration date: 09Apr2021, when the patient was 20 years old, for COVID-19 immunization. The following information was reported: COUGH (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Coughing"; ABDOMINAL PAIN (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Abdominal Pain"; CHEST PAIN (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Chest pain"; HYPERTENSION (medically significant), HEART RATE INCREASED (medically significant) all with onset 20Jan2022 18:30, outcome "not recovered" and all described as "High BP and HR"; HEADACHE (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Headache"; BACK PAIN (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Back pain"; PALPITATIONS (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Palpitations"; INSOMNIA (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Insomnia because of the pain". The events "coughing", "abdominal pain", "chest pain", "high BP and HR", "high BP and HR", "headache", "back pain", "palpitations" and "insomnia because of the pain" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (20Jan2022) high; heart rate: (20Jan2022) high. Therapeutic measures were taken as a result of cough, abdominal pain, chest pain, hypertension, heart rate increased, headache, back pain, palpitations, insomnia. Clinical Course: The patient experienced coughing, Abdominal Pain, Chest pain, high BP and HR, headache, back pain, palpitations, and insomnia because of the pain. AE treatment included Tylenol and Ibuprofen. No other vaccine in four weeks. No Covid prior vaccination and no Covid tested post vaccination.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Hypertension, Insomnia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 12:00 (Lot number: 33025BD) at the age of 20 years as dose 2 (booster), single for Covid-19 immunisation. Relevant medical history included: "Johnson & Johnson Dose Number: 1", start date: 20Jan2022 (unspecified if ongoing), notes: Verbatim: Johnson & Johnson Dose Number: 1. The patient's concomitant medications were not reported. Vaccination history included: Johnson & Johnson (Dose Number: 1, Batch/Lot No: 201A21A, Location of injection: Arm Left, Vaccine Administration Time: 03:45 PM), administration date: 09Apr2021, when the patient was 20 years old, for COVID-19 immunization. The following information was reported: COUGH (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Coughing"; ABDOMINAL PAIN (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Abdominal Pain"; CHEST PAIN (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Chest pain"; HYPERTENSION (medically significant), HEART RATE INCREASED (medically significant) all with onset 20Jan2022 18:30, outcome "not recovered" and all described as "High BP and HR"; HEADACHE (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Headache"; BACK PAIN (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Back pain"; PALPITATIONS (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Palpitations"; INSOMNIA (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Insomnia because of the pain". The events "coughing", "abdominal pain", "chest pain", "high BP and HR", "high BP and HR", "headache", "back pain", "palpitations" and "insomnia because of the pain" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (20Jan2022) high; heart rate: (20Jan2022) high. Therapeutic measures were taken as a result of cough, abdominal pain, chest pain, hypertension, heart rate increased, headache, back pain, palpitations, insomnia. Clinical Course: The patient experienced coughing, Abdominal Pain, Chest pain, high BP and HR, headache, back pain, palpitations, and insomnia because of the pain. AE treatment included Tylenol and Ibuprofen. No other vaccine in four weeks. No Covid prior vaccination and no Covid tested post vaccination.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 12:00 (Lot number: 33025BD) at the age of 20 years as dose 2 (booster), single for Covid-19 immunisation. Relevant medical history included: "Johnson & Johnson Dose Number: 1", start date: 20Jan2022 (unspecified if ongoing), notes: Verbatim: Johnson & Johnson Dose Number: 1. The patient's concomitant medications were not reported. Vaccination history included: Johnson & Johnson (Dose Number: 1, Batch/Lot No: 201A21A, Location of injection: Arm Left, Vaccine Administration Time: 03:45 PM), administration date: 09Apr2021, when the patient was 20 years old, for COVID-19 immunization. The following information was reported: COUGH (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Coughing"; ABDOMINAL PAIN (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Abdominal Pain"; CHEST PAIN (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Chest pain"; HYPERTENSION (medically significant), HEART RATE INCREASED (medically significant) all with onset 20Jan2022 18:30, outcome "not recovered" and all described as "High BP and HR"; HEADACHE (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Headache"; BACK PAIN (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Back pain"; PALPITATIONS (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Palpitations"; INSOMNIA (medically significant) with onset 20Jan2022 18:30, outcome "not recovered", described as "Insomnia because of the pain". The events "coughing", "abdominal pain", "chest pain", "high BP and HR", "high BP and HR", "headache", "back pain", "palpitations" and "insomnia because of the pain" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (20Jan2022) high; heart rate: (20Jan2022) high. Therapeutic measures were taken as a result of cough, abdominal pain, chest pain, hypertension, heart rate increased, headache, back pain, palpitations, insomnia. Clinical Course: The patient experienced coughing, Abdominal Pain, Chest pain, high BP and HR, headache, back pain, palpitations, and insomnia because of the pain. AE treatment included Tylenol and Ibuprofen. No other vaccine in four weeks. No Covid prior vaccination and no Covid tested post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Anaphylactic reaction, Arthralgia, Hepatic pain, Pain in extremity
Clinical narrative: anaphylaxis; long time acute arm and shoulders pain; long time acute arm and shoulders pain; spleen and liver pain; spleen and liver pain; recurrent swallowing bumps on chest and neck; Recurrent rashes on face; 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) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "long time acute arm and shoulders pain"; ABDOMINAL PAIN (non-serious), HEPATIC PAIN (non-serious), outcome "unknown" and all described as "spleen and liver pain"; SKIN DISORDER (non-serious), outcome "unknown", described as "recurrent swallowing bumps on chest and neck"; RASH (non-serious), outcome "unknown", described as "Recurrent rashes on face".Please explain why this spike protein stay so long in body and destroy organs. What the had to do recover faster and improve my status que.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Skin disorder
Clinical narrative: anaphylaxis; long time acute arm and shoulders pain; long time acute arm and shoulders pain; spleen and liver pain; spleen and liver pain; recurrent swallowing bumps on chest and neck; Recurrent rashes on face; 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) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "long time acute arm and shoulders pain"; ABDOMINAL PAIN (non-serious), HEPATIC PAIN (non-serious), outcome "unknown" and all described as "spleen and liver pain"; SKIN DISORDER (non-serious), outcome "unknown", described as "recurrent swallowing bumps on chest and neck"; RASH (non-serious), outcome "unknown", described as "Recurrent rashes on face".Please explain why this spike protein stay so long in body and destroy organs. What the had to do recover faster and improve my status que.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: DEATH (death), outcome "fatal", described as "died days after receiving a coronavirus vaccination". The patient date of death was unknown. The reported cause of death was "died days after receiving a coronavirus vaccination". It was not reported if an autopsy was performed. Patient was a teenager. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Reported Cause(s) of Death: died days after receiving a coronavirus vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had covid infection and then again for 10 days around each pfizer covid vaccine shot; had covid infection and then again for 10 days around each pfizer covid vaccine shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "colonoscopy", start date: 2015 (unspecified if ongoing), notes: Reports a normal colonoscopy in 2015 with no polyps. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2020, outcome "unknown" and all described as "had covid infection and then again for 10 days around each pfizer covid vaccine shot". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2020) she had covid infection, notes: States she stopped it (xeljanz) for 3 weeks in Dec2020 when she had covid infection and then again for 10 days around each pfizer covid vaccine shot (as per recommended by her hcp).  Clinical course: The patient stopped Xeljanz for 3 weeks in Dec2020 when she had Covid infection and then again for 10 days around each pfizer covid vaccine shot (as per recommended by her HCP). Her HCP was referring her to a GI specialist.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Feeling abnormal, Lymph node pain
Clinical narrative: Joint pain; Swelling of the lymph nodes; Vomiting; Fever of 102; Bad side effect neurological; Lymph node hurts and in the arm; Lymph node hurts and in the arm; There was wired feeling on her neck that will be neck; Extreme exhaustion all over her body specifically neck part near her arm; Short term memory is very bad/not able to put words together or recall words; Nerve pain at her back of neck; 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. Other Case identifier(s): US-PFIZER INC-202200354704 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 11Feb2022 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: NERVOUS SYSTEM DISORDER (non-serious) with onset 2022, outcome "unknown", described as "Bad side effect neurological"; VOMITING (non-serious) with onset 11Feb2022, outcome "unknown", described as "Vomiting"; PYREXIA (non-serious) with onset 11Feb2022, outcome "unknown", described as "Fever of 102"; ARTHRALGIA (non-serious) with onset 12Feb2022, outcome "unknown", described as "Joint pain"; LYMPH NODE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2022, outcome "unknown" and all described as "Lymph node hurts and in the arm"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "There was wired feeling on her neck that will be neck"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "Extreme exhaustion all over her body specifically neck part near her arm"; MEMORY IMPAIRMENT (non-serious) with onset 2022, outcome "unknown", described as "Short term memory is very bad/not able to put words together or recall words"; NEURALGIA (non-serious) with onset 2022, outcome "unknown", described as "Nerve pain at her back of neck"; LYMPHADENOPATHY (non-serious) with onset 12Feb2022, outcome "unknown", described as "Swelling of the lymph nodes". The events "bad side effect neurological", "vomiting", "fever of 102", "joint pain", "lymph node hurts and in the arm", "lymph node hurts and in the arm", "there was wired feeling on her neck that will be neck", "extreme exhaustion all over her body specifically neck part near her arm", "short term memory is very bad/not able to put words together or recall words", "nerve pain at her back of neck" and "swelling of the lymph nodes" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Memory impairment, Nervous system disorder, Neuralgia, Pain in extremity
Clinical narrative: Joint pain; Swelling of the lymph nodes; Vomiting; Fever of 102; Bad side effect neurological; Lymph node hurts and in the arm; Lymph node hurts and in the arm; There was wired feeling on her neck that will be neck; Extreme exhaustion all over her body specifically neck part near her arm; Short term memory is very bad/not able to put words together or recall words; Nerve pain at her back of neck; 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. Other Case identifier(s): US-PFIZER INC-202200354704 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 11Feb2022 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: NERVOUS SYSTEM DISORDER (non-serious) with onset 2022, outcome "unknown", described as "Bad side effect neurological"; VOMITING (non-serious) with onset 11Feb2022, outcome "unknown", described as "Vomiting"; PYREXIA (non-serious) with onset 11Feb2022, outcome "unknown", described as "Fever of 102"; ARTHRALGIA (non-serious) with onset 12Feb2022, outcome "unknown", described as "Joint pain"; LYMPH NODE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2022, outcome "unknown" and all described as "Lymph node hurts and in the arm"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "There was wired feeling on her neck that will be neck"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "Extreme exhaustion all over her body specifically neck part near her arm"; MEMORY IMPAIRMENT (non-serious) with onset 2022, outcome "unknown", described as "Short term memory is very bad/not able to put words together or recall words"; NEURALGIA (non-serious) with onset 2022, outcome "unknown", described as "Nerve pain at her back of neck"; LYMPHADENOPATHY (non-serious) with onset 12Feb2022, outcome "unknown", described as "Swelling of the lymph nodes". The events "bad side effect neurological", "vomiting", "fever of 102", "joint pain", "lymph node hurts and in the arm", "lymph node hurts and in the arm", "there was wired feeling on her neck that will be neck", "extreme exhaustion all over her body specifically neck part near her arm", "short term memory is very bad/not able to put words together or recall words", "nerve pain at her back of neck" and "swelling of the lymph nodes" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Joint pain; Swelling of the lymph nodes; Vomiting; Fever of 102; Bad side effect neurological; Lymph node hurts and in the arm; Lymph node hurts and in the arm; There was wired feeling on her neck that will be neck; Extreme exhaustion all over her body specifically neck part near her arm; Short term memory is very bad/not able to put words together or recall words; Nerve pain at her back of neck; 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. Other Case identifier(s): US-PFIZER INC-202200354704 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 11Feb2022 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: NERVOUS SYSTEM DISORDER (non-serious) with onset 2022, outcome "unknown", described as "Bad side effect neurological"; VOMITING (non-serious) with onset 11Feb2022, outcome "unknown", described as "Vomiting"; PYREXIA (non-serious) with onset 11Feb2022, outcome "unknown", described as "Fever of 102"; ARTHRALGIA (non-serious) with onset 12Feb2022, outcome "unknown", described as "Joint pain"; LYMPH NODE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2022, outcome "unknown" and all described as "Lymph node hurts and in the arm"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "There was wired feeling on her neck that will be neck"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "Extreme exhaustion all over her body specifically neck part near her arm"; MEMORY IMPAIRMENT (non-serious) with onset 2022, outcome "unknown", described as "Short term memory is very bad/not able to put words together or recall words"; NEURALGIA (non-serious) with onset 2022, outcome "unknown", described as "Nerve pain at her back of neck"; LYMPHADENOPATHY (non-serious) with onset 12Feb2022, outcome "unknown", described as "Swelling of the lymph nodes". The events "bad side effect neurological", "vomiting", "fever of 102", "joint pain", "lymph node hurts and in the arm", "lymph node hurts and in the arm", "there was wired feeling on her neck that will be neck", "extreme exhaustion all over her body specifically neck part near her arm", "short term memory is very bad/not able to put words together or recall words", "nerve pain at her back of neck" and "swelling of the lymph nodes" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: DEATH (death), outcome "fatal", described as "2 babies died during the trial period". The patient date of death was unknown. The reported cause of death was "2 babies died during the trial period". The reporter wanted to get information about the first 400 pages documents for the Pfizer vaccine. She mentioned that she is very concerned about the documents being released publicly. She also mentioned about the 3 month trial period where there is a recall on babies and she also mentioned that 2 babies died during the trial period and she's very concerned about it. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200354956 Same reporter/drug/event; different patient; Reported Cause(s) of Death: 2 babies died during the trial period.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, (tris) single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "2 babies died during the trial period". The patient date of death was unknown. The reported cause of death was "2 babies died during the trial period". The reporter wanted to get information about the first 400 pages documents for the Pfizer vaccine. She mentioned that she is very concerned about the documents being released publicly. She also mentioned about the 3 month trial period where there is a recall on babies and she also mentioned that 2 babies died during the trial period and she's very concerned about it. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200354814 Same reporter / drug / event, different patients.; Reported Cause(s) of Death: 2 babies died during the trial period.