chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid on 08Nov2022; Tested positive for Covid on 08Nov2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 05May2021 as dose 2, single (Lot number: EW0167), in left arm, on 18Nov2021 at 10:15 as dose 3 (booster), single (Lot number: FN2908), in left arm and on 02Jun2022 as dose 4 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "brain aneurysm" (unspecified if ongoing), notes: brain aneurysm. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergy", notes: Sensitive to aspirin; Ibuprofen, reaction(s): "Allergy", notes: Sensitive to ibuprofen. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Nov2022, outcome "not recovered" and all described as "Tested positive for Covid on 08Nov2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 for which included  PF-07321332, ritonavir (PAXLOVID) from 08Nov2022 to 12Nov2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid on 08Nov2022; Tested positive for Covid on 08Nov2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 05May2021 as dose 2, single (Lot number: EW0167), in left arm, on 18Nov2021 at 10:15 as dose 3 (booster), single (Lot number: FN2908), in left arm and on 02Jun2022 as dose 4 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "brain aneurysm" (unspecified if ongoing), notes: brain aneurysm. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergy", notes: Sensitive to aspirin; Ibuprofen, reaction(s): "Allergy", notes: Sensitive to ibuprofen. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Nov2022, outcome "not recovered" and all described as "Tested positive for Covid on 08Nov2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 for which included  PF-07321332, ritonavir (PAXLOVID) from 08Nov2022 to 12Nov2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 as dose 4 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "brain aneurysm" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sensitive to aspirin for Known allergies: Sensitive to aspirin, notes: Sensitive to aspirin and ibuprofen; Ibuprofen for Known allergies: ibuprofen. Vaccination history included: BNT162b2 (Pfizer/BioNTech, lot number was EW0153, dose 1, left arm), administration date: 14Apr2021, for Covid-19 Immunization, reaction(s): "Sore arm", "fatigue"; BNT162b2 (Pfizer/BioNTech, lot number was EW0167, dose 2, left arm.), administration date: 05May2021, for Covid-19 Immunization, reaction(s): "Sore arm", "fatigue"; BNT162b2 (Pfizer/BioNTech , administration time was 10:15 AM, lot number was FN2908, dose 3, left arm), administration date: 18Nov2021, for Covid-19 Immunization, reaction(s): "Sore arm", "fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative for two days; (unspecified date) Negative, notes: tested negative for two days; (unspecified date) Positive, notes: Then on third day, tested positive for covid again; (08Nov2022) Positive, notes: Tested positive for Covid on 08Nov2022. Therapeutic measures were taken as a result of pain in extremity, fatigue.  Additional information: Adverse events for the Pfizer Covid shots and boosters was Sore arm and fatigue. Tested positive for Covid on 08Nov2022: fever, headache, body aches and fatigue. For Paxlovid: Metallic taste that distorted sense of taste Completed the 5 day regimen and then tested negative for two days. Then on third day, tested positive for covid again. Symptoms was sneezing, nasal congestion, runny nose, cough, some fatigue. Even eight days after completing Paxlovid, still testing positive with sneezing, coughing, nasal congestion. Took Paxlovid from 08Nov2022 to 12Nov2022 as COVID 19 treatment. Other medication details: Amlodipline-Benazepril, clopidogrel 75 mg, Raloxifene, Multi for Her 50+ from 01Nov2022 to 21Nov2022 and Rosuvastatin from 01Nov2022 to 07Nov2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 as dose 4 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "brain aneurysm" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sensitive to aspirin for Known allergies: Sensitive to aspirin, notes: Sensitive to aspirin and ibuprofen; Ibuprofen for Known allergies: ibuprofen. Vaccination history included: BNT162b2 (Pfizer/BioNTech, lot number was EW0153, dose 1, left arm), administration date: 14Apr2021, for Covid-19 Immunization, reaction(s): "Sore arm", "fatigue"; BNT162b2 (Pfizer/BioNTech, lot number was EW0167, dose 2, left arm.), administration date: 05May2021, for Covid-19 Immunization, reaction(s): "Sore arm", "fatigue"; BNT162b2 (Pfizer/BioNTech , administration time was 10:15 AM, lot number was FN2908, dose 3, left arm), administration date: 18Nov2021, for Covid-19 Immunization, reaction(s): "Sore arm", "fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative for two days; (unspecified date) Negative, notes: tested negative for two days; (unspecified date) Positive, notes: Then on third day, tested positive for covid again; (08Nov2022) Positive, notes: Tested positive for Covid on 08Nov2022. Therapeutic measures were taken as a result of pain in extremity, fatigue.  Additional information: Adverse events for the Pfizer Covid shots and boosters was Sore arm and fatigue. Tested positive for Covid on 08Nov2022: fever, headache, body aches and fatigue. For Paxlovid: Metallic taste that distorted sense of taste Completed the 5 day regimen and then tested negative for two days. Then on third day, tested positive for covid again. Symptoms was sneezing, nasal congestion, runny nose, cough, some fatigue. Even eight days after completing Paxlovid, still testing positive with sneezing, coughing, nasal congestion. Took Paxlovid from 08Nov2022 to 12Nov2022 as COVID 19 treatment. Other medication details: Amlodipline-Benazepril, clopidogrel 75 mg, Raloxifene, Multi for Her 50+ from 01Nov2022 to 21Nov2022 and Rosuvastatin from 01Nov2022 to 07Nov2022.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8732), in left arm, on 04May2021 as dose 2, single (Lot number: EW0167), in left arm and on 21Nov2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Jun2022 as dose 4 (booster), single (Lot number: 054A22A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19; (08Nov2022) Negative; (09Nov2022) Negative; (12Nov2022) Positive; (12Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was used for treatment of COVID-19 from 03Nov2022 to 07Nov2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: Rebound positive test 5 days after 2 negative tests; (Nov2022) Negative, notes: Rebound positive test 5 days after 2 negative tests; (21Nov2022) Positive, notes: Rebound positive test 5 days after 2 negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had no known allergies. From 09Nov2022 to 13Nov2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: EW0153), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "brain aneurysm" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: sensitive to aspirin, reaction(s): "Drug allergy"; Known allergies: sensitive to ibuprofen, reaction(s): "Drug allergy". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2021 as dose 2, single (Lot number: EW0167), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "brain aneurysm" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: sensitive to aspirin for Drug allergy; Known allergies: sensitive to ibuprofen for Drug allergy. Vaccination history included: BNT162b2 (lot No: EW0153, Dose 1, on Left arm), administration date: 14Apr2021, for Covid-19 immunization, reaction(s): "Sore arm", "fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: For the Pfizer Covid shots and boosters: Sore arm and fatigue.vaccine was received, yes, other medication in 2weeks  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 at 10:15 as dose 3 (booster), single (Lot number: FN2908), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other Medical History: high blood pressure; "high cholesterol" (unspecified if ongoing); "brain aneurysm" (unspecified if ongoing), notes: Other Medical History: brain aneurysm. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies: Sensitive to aspirin", notes: known allergies: Sensitive to aspirin; Ibuprofen, reaction(s): "known allergies: Sensitive to ibuprofen", notes: known allergies: Sensitive to ibuprofen. Vaccination history included: BNT162b2 (DOSE 1, lot number: EW0153, location: Left arm), administration date: 14Apr2021, for Covid-19 immunization, reaction(s): "Sore arm", "fatigue"; BNT162b2 (DOSE 2, lot number: EW0167, location: Left arm), administration date: 05May2021, for Covid-19 immunization, reaction(s): "Sore arm", "fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown". No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Treatment start date was 12Nov2022 and stop date was 17Nov2022.  Clinical course: Patient did not receive other medication in 2 weeks. Patient had no known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Foetal exposure during pregnancy, Low birth weight baby, Premature baby, Weight
Clinical narrative: delivered her baby early at 35 weeks pregnancy; delivered her baby early at 35 weeks pregnancy; he was 4 pounds 14 ounces; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the parent.  A male patient was exposed to BNT162b2 (COMIRNATY), transplacental, administration details for the mother: as dose number unknown, single (Lot number: Unknown) for covid-19 immunisation. The mother was 35 weeks pregnant at the event onset. The mother is expected to deliver one baby(s). The mother's relevant medical history and concomitant medications were not reported. The following information was reported: FOETAL EXPOSURE DURING PREGNANCY (non-serious), PREMATURE BABY (non-serious), outcome "unknown" and all described as "delivered her baby early at 35 weeks pregnancy"; LOW BIRTH WEIGHT BABY (non-serious), outcome "unknown", described as "he was 4 pounds 14 ounces". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The mother had the covid vaccine during pregnancy. She delivered her baby early at 35 weeks pregnancy. Baby boy was healthy, although he was 4 pounds 14 ounces. She believes the early delivery was due to covid vaccine. Event took place after use of product.  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-PV202200108785 Mother/Baby;
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 11:00 as dose 5 (booster), single (Lot number: G25342) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Apr2022 as dose 4 (booster), single (Lot number: O56M21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis." (unspecified if ongoing), notes: Other medical history Osteoporosis. Concomitant medication(s) included: TESTOSTERONE, start date: 01Jan2022, stop date: 21Nov2022; CHLORTALIDONE, start date: 01Jan2022, stop date: 21Nov2022; ALENDRONATE, start date: 01Jan2022, stop date: 20Nov2022; POTASSIUM CHLORIDE, start date: 01Jan2022, stop date: 21Nov2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products "; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2022) Positive, notes: Tested positive 18Nov2022.  Clinical course: Patient received other medication in 2week. He received no treatment and had no known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I got the Pfizer covid shots and booster shot, so I was really surprised I get it (the covid infection; I got the Pfizer covid shots and booster shot, so I was really surprised I get it (the covid infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 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) 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 "I got the Pfizer covid shots and booster shot, so I was really surprised I get it (the covid infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took a home test and it showed it was positive, then my doctor did a test and told me its positive; Positive, notes: I took a home test and it showed it was positive, then my doctor did a test and told me its positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events: She got the Pfizer covid shots and booster shot, so she was really surprised she even got this (the covid infection, she got the shot, she has worn her mask, she never had a problem like this even as a result after receiving the booster shot. She was fine 1 minute and 15 minutes later she felt like she was hit by a truck, that's how bad and fast it hit, this was not a gradual getting sick, the chills and pain, headache, nausea, fever. She took a home test and it showed it was positive, then her doctor did a test and told her it was positive and started her on Paxlovid, apparently from the day you start you have 2 days to start it. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Patient contracted COVID-19 after initial booster; Patient contracted COVID-19 after initial booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Patient contracted COVID-19 after initial booster".  Clinical course: Patient contracted COVID-19 after receiving the initial booster.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoacusis, Visual impairment
Clinical narrative: Unilateral hearing and vision issues; Unilateral hearing and vision issues; Allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004105 (Novavax).  A female patient received BNT162B2, as dose 2, 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 1), for COVID-19 Immunization. The following information was reported: HYPOACUSIS (non-serious), VISUAL IMPAIRMENT (non-serious), outcome "unknown" and all described as "Unilateral hearing and vision issues"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergy". Additional information: It was reported that the patient experienced unilateral hearing and vision issues and had an allergy.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: she has allergies and possible allergic to the COVID vaccine and also might have taken Xanax after getting the COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  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 included: "allergies" (unspecified if ongoing), notes: allergies. Concomitant medication(s) included: XANAX. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "she has allergies and possible allergic to the COVID vaccine and also might have taken Xanax after getting the COVID vaccine".  Additional information: Patient mentioned that she has allergies and possible allergic to the COVID vaccine and also might have taken Xanax after getting the COVID vaccine. Caller wanted to know the correct number for Viatris regarding Xanax. Also mentioned that she haven't gotten her booster dose because they didn't want to give it to her because she is allergies, she knows there is a clinical trials ongoing about allergies and wanted to know what is the outcome.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Feeling hot, Hyperhidrosis, Hypoaesthesia
Clinical narrative: lost consciousness/unconscious; shaking; labored breath; pain in left arm where patient had the injection; felt weak; overheated; sweaty; numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient was a healthy person. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ASTHENIA (non-serious) with onset Nov2022, outcome "unknown", described as "felt weak"; DYSPNOEA (non-serious) with onset Nov2022, outcome "unknown", described as "labored breath"; LOSS OF CONSCIOUSNESS (medically significant) with onset Nov2022, outcome "unknown", described as "lost consciousness/unconscious"; HYPOAESTHESIA (non-serious) with onset Nov2022, outcome "unknown", described as "numb"; FEELING HOT (non-serious) with onset Nov2022, outcome "unknown", described as "overheated"; VACCINATION SITE PAIN (non-serious) with onset Nov2022, outcome "unknown", described as "pain in left arm where patient had the injection"; TREMOR (non-serious) with onset Nov2022, outcome "unknown", described as "shaking"; HYPERHIDROSIS (non-serious) with onset Nov2022, outcome "unknown", described as "sweaty".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness, Tremor, Vaccination site pain
Clinical narrative: lost consciousness/unconscious; shaking; labored breath; pain in left arm where patient had the injection; felt weak; overheated; sweaty; numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient was a healthy person. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ASTHENIA (non-serious) with onset Nov2022, outcome "unknown", described as "felt weak"; DYSPNOEA (non-serious) with onset Nov2022, outcome "unknown", described as "labored breath"; LOSS OF CONSCIOUSNESS (medically significant) with onset Nov2022, outcome "unknown", described as "lost consciousness/unconscious"; HYPOAESTHESIA (non-serious) with onset Nov2022, outcome "unknown", described as "numb"; FEELING HOT (non-serious) with onset Nov2022, outcome "unknown", described as "overheated"; VACCINATION SITE PAIN (non-serious) with onset Nov2022, outcome "unknown", described as "pain in left arm where patient had the injection"; TREMOR (non-serious) with onset Nov2022, outcome "unknown", described as "shaking"; HYPERHIDROSIS (non-serious) with onset Nov2022, outcome "unknown", described as "sweaty".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: I recently came close to losing my life because of blood clots in my Lungs and Leg; I recently came close to losing my life because of blood clots in my Lungs and Leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, 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 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (life threatening), THROMBOSIS (life threatening), outcome "unknown" and all described as "I recently came close to losing my life because of blood clots in my Lungs and Leg". The events "i recently came close to losing my life because of blood clots in my lungs and leg" required physician office visit. Clinical course: The patient stated that he/she recently came close to losing his/her life because of blood clots in lungs and leg. The patient's doctors have not found a reason for the blood clots. The patient's question is whether the Covid Vaccine is causing blood clots in people that have had the vaccine. 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: Death
Clinical narrative: my 56 year old husband die a week after he received your vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56-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 and concomitant medications were not reported.  The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "my 56 year old husband die a week after he received your vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical information: It was reported that reporter asked why did her 56 year old husband died in a week after he received the vaccine and her 8 year old daughter and she would like an answer and said it was safe for everyone you lied. Event Awareness Date: 20Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: my 56 year old husband die a week after he received your vaccine
Sex: U
Vaccine: COVID19-2
Symptoms: Chills, Erythema, Fatigue, Nasopharyngitis, Nausea
Clinical narrative: nauseous; tired; arm is extremely red; fever; cold chills; cold; was given the wrong shot; 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 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nauseous"; FATIGUE (non-serious), outcome "unknown", described as "tired"; ERYTHEMA (non-serious), outcome "unknown", described as "arm is extremely red"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "not recovered", described as "cold chills"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "cold"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "was given the wrong shot".  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Pyrexia, Wrong product administered
Clinical narrative: nauseous; tired; arm is extremely red; fever; cold chills; cold; was given the wrong shot; 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 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nauseous"; FATIGUE (non-serious), outcome "unknown", described as "tired"; ERYTHEMA (non-serious), outcome "unknown", described as "arm is extremely red"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "not recovered", described as "cold chills"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "cold"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "was given the wrong shot".  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pains ever since that has been undiagnosable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  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: CHEST PAIN (non-serious), outcome "unknown", described as "Chest pains ever since that has been undiagnosable".  Additional information: Wife of the patient said that he got the Pfizer COVID vaccination and has been having chest pains ever since that has been undiagnosable. We heard that there may be some clinical research into the side effects of the Covid vaccination and didn't know if this was something that was available to him.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19-2
Symptoms: Protein urine, Urine analysis
Clinical narrative: Releases protein through my urine; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Bnt162b2 (Dose 1, Single; Pfizer Product: Covid Vaccine), for COVID-19 Immunization; Bnt162b2 (Dose 2, Single; Pfizer Product: Covid Vaccine.), for COVID-19 Immunization. The following information was reported: PROTEIN URINE (non-serious), outcome "unknown", described as "Releases protein through my urine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A potential AE has been reported to the Pfizer Clinical Trials Contact Center. Patient reported, I had new product syndrome which releases protein through my urine. I've had three COVID vaccines.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches/situation was getting worse; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Apr2022 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 (Primary immunization series complete; manufacturer unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2022, outcome "not recovered", described as "headaches/situation was getting worse".  Additional information: It was also reported that patient was calling concerning Pfizer's COVID-19 booster shot. He reported that he received the booster last April and that he was suffering from headaches. He added that he was still suffering from headaches and that the situation was getting worse. He would like to know more about the cause. He still had headaches and it was getting worse.  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
Clinical narrative: Contracted COVID 19 in May2022; Contracted COVID 19 in May2022; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in Jun2021 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 May2022, outcome "unknown" and all described as "Contracted COVID 19 in May2022".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200108580 Same patient/vaccine; different dose and event.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Tachycardia
Clinical narrative: Off label use; Booster; It was reported the patient woke up with a bad case of tachycardia and stayed in the hospital; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004115 (Novavax).  A 19-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 19 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE , UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE , UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 26Feb2022, outcome "unknown", described as "Booster"; OFF LABEL USE (hospitalization) with onset 26Feb2022, outcome "unknown"; TACHYCARDIA (hospitalization) with onset 2022, outcome "recovered" (2022), described as "It was reported the patient woke up with a bad case of tachycardia and stayed in the hospital". Clinical course: On 04Nov2022, it was reported that a patient started treatment on 26Feb2022 with Pfizer BioNTech COVID-19 Vaccine 3rd booster dose for COVID-19 immunisation. It was reported the patient woke up with a bad case of tachycardia and stayed in the hospital. It resolved within 2 days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature would drop below range and then come back into range on and off and minimum temperature overall was reported to be 31F with no reported adverse event; administration post excursion with no reported event; Initial information received on 17-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age male patient for whom reported reported temperature drop below range for  meningococcal a-c-y-w135 (d conj) vaccine [Menactra] and then came back into range on and off and minimum temperature overall was reported to be 31f with no reported adverse event and administration post excursion with no reported event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection (with an unknown strength, dose, frequency, route, expiry date, batch number, administration site) for prophylactic vaccination.   On an unknown date the temperature dropped below range and then came back into range on and off and minimum temperature overall was reported to be 31f with no reported adverse event (product storage error) and administration post excursion with no reported event (poor quality product administered) (unknown latency).  Reportedly, Excursion started on 1Aug2022 due to a unit malfunction.  Action taken was not applicable.   Outcome was Unknown for both events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu every year within 2 days of the shot; Initial information received on 14-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer.   This case involves a female patient of unknown age and her husband reported got the flu every year within 2 days of the shot while receiving vaccine influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "got the flu every year within 2 days of the shot (influenza)" (unknown latency) following the administration of influenza vaccine.  It was reported that the patient got the flu every year, within 2 days of the shot (onset and latency: unknown). Further reported that after she had stop taking the shot, she has not had the flu in over 4 years."  It is unknown if there were lab data/results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.