chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive by home test last on 10Sep2022; tested positive by home test last on 10Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Batch/Lot number: unknown), on 05Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Sep2022, outcome "unknown" and all described as "tested positive by home test last on 10Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Sep2022) Positive, notes: home test. Clinical course: The patient has received 3 doses of the Pfizer COVID-19 vaccine on 17Jan2021, 05Feb2021, and 29Nov2021. She tested positive by home test last on 10Sep2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE; CYMBALTA; TOPAMAX; CLONAZEPAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
Age: 58.0
Sex: M
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 07Apr2021 as dose 2, single (Lot number: EN6204), in left arm and on 11Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing). Patient had no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication: Treatment of COVID-19; (23Sep2022) Negative; (26Sep2022) Positive, notes: Tested positive for COVID on 26Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bed rest, Chills, Decreased appetite, Fatigue
Clinical narrative: Extreme chills; Vomiting; No energy/had very little energy; Confined to bed and only slept; Eat very lightly (crackers, water, ginger ale); Still very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Extreme chills"; VOMITING (non-serious), outcome "unknown"; ASTHENIA (non-serious), outcome "unknown", described as "No energy/had very little energy"; BED REST (non-serious), outcome "unknown", described as "Confined to bed and only slept"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Eat very lightly (crackers, water, ginger ale)"; FATIGUE (non-serious), outcome "unknown", described as "Still very tired".  Additional information: Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused prolonged hospitalization: No. Seriousness criteria-Disabling Incapacitating: No. Seriousness criteria-Congenital anomaly birth defect: No. No other vaccine in four weeks. Other medications in two weeks:  55+ multivitamin. Adverse event: About 15 hours after the shot I had extreme chills for about 2 hours, starting adverse event extreme chills for about 2 hours, starting at 4 a.m. Beginning at about 9:00 vomiting began. I could not even take a sip of water without vomiting for the next 36 hours. During this time I had no energy and was confined to bed and only slept. Beginning about 48 hours after the shot I could eat very lightly (crackers, water, ginger ale) and still had very little energy. I was feeling more normal about 4 days after the shot, but still very tired. This was my 5th Pfizer shot, and I had the exact same reaction after all 5 doses. The patient had no covid prior to vaccination. Known allergies: No.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Extreme chills; Vomiting; No energy/had very little energy; Confined to bed and only slept; Eat very lightly (crackers, water, ginger ale); Still very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Extreme chills"; VOMITING (non-serious), outcome "unknown"; ASTHENIA (non-serious), outcome "unknown", described as "No energy/had very little energy"; BED REST (non-serious), outcome "unknown", described as "Confined to bed and only slept"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Eat very lightly (crackers, water, ginger ale)"; FATIGUE (non-serious), outcome "unknown", described as "Still very tired".  Additional information: Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused prolonged hospitalization: No. Seriousness criteria-Disabling Incapacitating: No. Seriousness criteria-Congenital anomaly birth defect: No. No other vaccine in four weeks. Other medications in two weeks:  55+ multivitamin. Adverse event: About 15 hours after the shot I had extreme chills for about 2 hours, starting adverse event extreme chills for about 2 hours, starting at 4 a.m. Beginning at about 9:00 vomiting began. I could not even take a sip of water without vomiting for the next 36 hours. During this time I had no energy and was confined to bed and only slept. Beginning about 48 hours after the shot I could eat very lightly (crackers, water, ginger ale) and still had very little energy. I was feeling more normal about 4 days after the shot, but still very tired. This was my 5th Pfizer shot, and I had the exact same reaction after all 5 doses. The patient had no covid prior to vaccination. Known allergies: No.    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: Asthenia, Chills, Decreased appetite, Fatigue, Hypersomnia
Clinical narrative: Wrong vaccine administered; extreme chills; no energy/had very little energy; vomiting; confined to bed and only slept; eat very lightly (crackers, water, ginger ale); very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (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 had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "had no energy", "extreme chills", "could eat very lightly", "very tired", "confined to bed and only slept", "Vomiting"; Bnt162b2 (Dose 2, Single), for COVID-19 Immunization, reaction(s): "had no energy", "extreme chills", "could eat very lightly", "very tired", "confined to bed and only slept", "Vomiting"; Bnt162b2 (Dose 3, Single), for COVID-19 Immunization, reaction(s): "had no energy", "extreme chills", "could eat very lightly", "very tired", "confined to bed and only slept", "Vomiting". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Wrong vaccine administered"; CHILLS (non-serious), outcome "unknown", described as "extreme chills"; ASTHENIA (non-serious), outcome "unknown", described as "no energy/had very little energy"; VOMITING (non-serious), outcome "unknown"; HYPERSOMNIA (non-serious), outcome "unknown", described as "confined to bed and only slept"; DECREASED APPETITE (non-serious), outcome "unknown", described as "eat very lightly (crackers, water, ginger ale)"; FATIGUE (non-serious), outcome "unknown", described as "very tired".  Additional information: About 15 hours after the shot, the patient had extreme chills for about 2 hours, starting adverse event extreme chills for about 2 hours, starting at 4 a.m. Beginning at about 9:00 vomiting began. She could not even take a sip of water without vomiting for the next 36 hours. During this time, she had no energy and was confined to bed and only slept. Beginning about 48 hours after the shot, she could eat very lightly (crackers, water, ginger ale) and still had very little energy. She was feeling more normal about 4 days after the shot, but still very tired. This was her 5th Pfizer shot, and she had the exact same reaction after all 5 doses. Patient received 55+ multivitamin as other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. No known allergies reported.   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: F
Vaccine: COVID19
Symptoms: Vomiting, Wrong product administered
Clinical narrative: Wrong vaccine administered; extreme chills; no energy/had very little energy; vomiting; confined to bed and only slept; eat very lightly (crackers, water, ginger ale); very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (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 had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "had no energy", "extreme chills", "could eat very lightly", "very tired", "confined to bed and only slept", "Vomiting"; Bnt162b2 (Dose 2, Single), for COVID-19 Immunization, reaction(s): "had no energy", "extreme chills", "could eat very lightly", "very tired", "confined to bed and only slept", "Vomiting"; Bnt162b2 (Dose 3, Single), for COVID-19 Immunization, reaction(s): "had no energy", "extreme chills", "could eat very lightly", "very tired", "confined to bed and only slept", "Vomiting". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Wrong vaccine administered"; CHILLS (non-serious), outcome "unknown", described as "extreme chills"; ASTHENIA (non-serious), outcome "unknown", described as "no energy/had very little energy"; VOMITING (non-serious), outcome "unknown"; HYPERSOMNIA (non-serious), outcome "unknown", described as "confined to bed and only slept"; DECREASED APPETITE (non-serious), outcome "unknown", described as "eat very lightly (crackers, water, ginger ale)"; FATIGUE (non-serious), outcome "unknown", described as "very tired".  Additional information: About 15 hours after the shot, the patient had extreme chills for about 2 hours, starting adverse event extreme chills for about 2 hours, starting at 4 a.m. Beginning at about 9:00 vomiting began. She could not even take a sip of water without vomiting for the next 36 hours. During this time, she had no energy and was confined to bed and only slept. Beginning about 48 hours after the shot, she could eat very lightly (crackers, water, ginger ale) and still had very little energy. She was feeling more normal about 4 days after the shot, but still very tired. This was her 5th Pfizer shot, and she had the exact same reaction after all 5 doses. Patient received 55+ multivitamin as other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. No known allergies reported.   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
Symptoms: Chills, Pyrexia
Clinical narrative: Patient reports mild fever and chills for less than 24 hours after bivalent. States symptoms were less than with initial COVID-19 vaccine and previous booster; Patient reports mild fever and chills for less than 24 hours after bivalent. States symptoms were less than with initial COVID-19 vaccine and previous booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (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: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "Chills", "Fever".  The following information was reported: CHILLS (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "Patient reports mild fever and chills for less than 24 hours after bivalent. States symptoms were less than with initial COVID-19 vaccine and previous booster".  Additional information: It was reported that, patient reports mild fever and chills for less than 24 hours after bivalent. States symptoms were less than with initial Covid-19 vaccine and previous booster. 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.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jul2022 as dose 4 (booster), single (Lot number: FW1331) at the age of 52 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: low-grade; SARS-CoV-2 test: Negative, notes: 8 days after testing negative for COVID; Positive, notes: I took 2 at-home COVID tests using different brands and tested positive; Positive, notes: I took 2 at-home COVID tests using different brands and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including PAXLOVID given from 14Sep2022 to 24Sep2022.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteomyelitis" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "psudo gout" (unspecified if ongoing); "Raynauds" (unspecified if ongoing); "Achenbach syndrome" (unspecified if ongoing); "Restless leg" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 04Sep2022, stop date: 09Sep2022. Past drug history included: Known allergies: clindamycin, reaction(s): "Known allergies: Clindamycin".  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: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chest discomfort, Cough, Dizziness, Dyspnoea
Clinical narrative: tachycardia; shortness of breath; chest pressure; balance issues; muscle aches; cough; nausea; severe headache[s]; fatigue; racing heartbeat; dizziness/balance issues; chest pressure/tightness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP), Program ID:   A female patient received BNT162b2 (BNT162B2), as dose 1, 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: TACHYCARDIA (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest pressure"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance issues"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; COUGH (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "severe headache[s]"; FATIGUE (non-serious), outcome "unknown"; PALPITATIONS (non-serious), outcome "unknown", described as "racing heartbeat"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness/balance issues"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest pressure/tightness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Palpitations
Clinical narrative: tachycardia; shortness of breath; chest pressure; balance issues; muscle aches; cough; nausea; severe headache[s]; fatigue; racing heartbeat; dizziness/balance issues; chest pressure/tightness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP), Program ID:   A female patient received BNT162b2 (BNT162B2), as dose 1, 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: TACHYCARDIA (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest pressure"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance issues"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; COUGH (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "severe headache[s]"; FATIGUE (non-serious), outcome "unknown"; PALPITATIONS (non-serious), outcome "unknown", described as "racing heartbeat"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness/balance issues"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest pressure/tightness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; shortness of breath; chest pressure; balance issues; muscle aches; cough; nausea; severe headache[s]; fatigue; racing heartbeat; dizziness/balance issues; chest pressure/tightness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP), Program ID:   A female patient received BNT162b2 (BNT162B2), as dose 1, 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: TACHYCARDIA (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest pressure"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance issues"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; COUGH (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "severe headache[s]"; FATIGUE (non-serious), outcome "unknown"; PALPITATIONS (non-serious), outcome "unknown", described as "racing heartbeat"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness/balance issues"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest pressure/tightness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Coma, Illness, Myocardial infarction
Clinical narrative: Now I am a sick person, with 12 doctors to see; COVID-19 vaccine caused me to have 3 heart attacks (one was a stemi). I died for 3 minutes and was in a coma for more than two weeks; COVID-19 vaccine caused me to have 3 heart attacks (one was a stemi). I died for 3 minutes and was in a coma for more than two weeks; COVID-19 vaccine caused me to have 3 heart attacks (one was a stemi). I died for 3 minutes and was in a coma for more than two weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 31Mar2021 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: BNT162b2 (Dose 1, single), administration date: 10Mar2021, for Covid-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant, life threatening), ACUTE MYOCARDIAL INFARCTION (medically significant, life threatening), COMA (medically significant, life threatening) all with onset 02Aug2021, outcome "not recovered" and all described as "COVID-19 vaccine caused me to have 3 heart attacks (one was a stemi). I died for 3 minutes and was in a coma for more than two weeks"; ILLNESS (medically significant), outcome "not recovered", described as "Now I am a sick person, with 12 doctors to see". Clinical course: The patient believed that Pfizer COVID-19 vaccine caused the patient to have 3 heart attacks (one was a stemi). Patient reportedly died for 3 minutes and was in a coma for more than two weeks. The patient was a very healthy person before. Now, patient is a sick person, with 12 doctors to see. The patient's first vaccine was 10Mar2021 and the second one was 31Mar2021. Patient's heart attacks started 02Aug.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I have no idea why your vaccine has temporarily stopped the clicking.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2, solution for injection), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have a ailment, rapid intermittent clicking in my right ear" (ongoing), notes: I have a ailment, rapid intermittent clicking in my right ear. As the vaccine wears down the clicking returns. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have no idea why your vaccine has temporarily stopped the clicking.".  Additional information: Description of Event Outcome: Hi, Just a thank you for an unexpected benefit from your Covid vaccine. I have a ailment, rapid intermittent clicking in my right ear. I have been to many Doctors seeking relief, but nothing worked. I have no idea why your vaccine has temporarily stopped the clicking. As the vaccine wears down the clicking returns. So it's not a cure, but the relief it provides is very welcoming. If you have any idea how this works I'd welcome the info.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Herpes zoster
Clinical narrative: Bell's Palsy; Shingles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-000003478 (Novavax).  A 29-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: BELL'S PALSY (medically significant), outcome "unknown"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: have 2 kids that enlarged heart from this vaccine now; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the parent.  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: CARDIOMEGALY (non-serious), outcome "unknown", described as "have 2 kids that enlarged heart from this vaccine now".  Additional information: The reporter had 2 kids that enlarged heart from this vaccine now.  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) : PFIZER INC-202201188653 same reporter/drug/AE, different patients;
Sex: U
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Pfizer Bivalent covid-19 vaccine was administered 11Sep2022 then got the 2nd dose on 17Sep2022; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID:   A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 1, single (Batch/Lot number: unknown) and on 17Sep2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 11Sep2022, outcome "unknown", described as "Pfizer Bivalent covid-19 vaccine was administered 11Sep2022 then got the 2nd dose on 17Sep2022".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Gastrooesophageal reflux disease, Glucose tolerance impaired
Clinical narrative: Prediabetes; GERD; GERD; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 69-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 68 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "GAD" (unspecified if ongoing); "Breast cancer", start date: 2012 (unspecified if ongoing), notes: Pertinent Details: Bilateral mastectomy; "Bilateral mastectomy" (unspecified if ongoing); "Anxiety" (ongoing); "Dep" (ongoing); "GERD" (ongoing). Concomitant medication(s) included: LEXAPRO oral taken for anxiety, depression (ongoing); PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE] oral taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (Dose: 1st; Route of administration: Intramuscular; Batch/Lot number: Not Available / Provided at Time of Report Completion), administration date: 12Mar2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), DISEASE RECURRENCE (non-serious) all with onset 01Aug2022, outcome "unknown" and all described as "GERD"; GLUCOSE TOLERANCE IMPAIRED (non-serious) with onset 01Aug2022, outcome "unknown", described as "Prediabetes". Therapeutic measures were taken as a result of gastrooesophageal reflux disease, disease recurrence.  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: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Private).  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack".  Clinical course: When asked question to patient. What was the name of the company or organization featured in the advertising? she reported that she was not sure exactly but she had a almost heart attack from the vaccine so she was 100 percent against it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19-2
Symptoms: Headache, Vaccination site pain
Clinical narrative: headache; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from a sales representative. 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 number unknown (booster), single (Lot number: GJ5352) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Unknown manufacturer), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain".  Additional Information: Injection site pain and headache following COVID-19 bivalent booster. There was no underlying conditions or concomitant medications. Event took place after use of product.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19-2
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: lymphadenopathy; Injection site pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-healthcare professional) from a sales representative. 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 number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, Manufacturer unknown) for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain".  Additional information: Patient had no underlying conditions. Patient received concomitant flu vaccine in same arm. Event took place after use of COVID-19 bivalent booster.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: vaccines do not stop you from getting covid nor does it eliminate the need for hospitalization and it certainly doesnt stop you from dying. This i state from personal experience; vaccines do not stop you from getting covid nor does it eliminate the need for hospitalization and it certainly doesnt stop you from dying. This i state from personal experience; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Private). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "vaccines do not stop you from getting covid nor does it eliminate the need for hospitalization and it certainly doesnt stop you from dying. This i state from personal experience". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical course: There are no right or wrong answers, no silly or dumb feelings. Don't worry about spelling, punctuation, or grammar. I felt that this ad was spreading misinformation, vaccines do not stop you from getting covid nor does it eliminate the need for hospitalization and it certainly doesn't stop you from dying. This i state from personal experience.  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: Angioimmunoblastic T-cell lymphoma, Computerised tomogram, Lymphadenopathy, Night sweats, SARS-CoV-2 test
Clinical narrative: angioimmunoblastic T-cell lymphoma; night sweats; swollen lymph nodes in his neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in arm and in 2021 as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (medically significant, life threatening), outcome "unknown"; NIGHT SWEATS (non-serious), outcome "unknown"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes in his neck". The patient underwent the following laboratory tests and procedures: Computerised tomogram: It was cancer of the immune system-lymphoma., notes: revealed a smattering of inky spots, bunched near left armpit and running up along his neck. It was cancer of the immune system-lymphoma; The scans were clear, notes: yet another set of full-body CT images; The pictures showed a brand-new barrage of cancer, notes: -so many spots that it looked like someone had set off fireworks inside [name withheld] body. More than that, the lesions were now prominent on both sides of the body, with new clusters blooming in [name withheld] right armpit in particular, and along the right side of his neck; SARS-CoV-2 test: Just a few days before (name witheld) got COVID, notes: COVID had finally caught up with him. Therapeutic measures were taken as a result of angioimmunoblastic t-cell lymphoma including brentuximab vedotin. It was also reported that patient age was 67.   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) : BE-PFIZER INC-202101810811 Same patient, same vaccine in different dose, with same event;
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: vaccine exposure during pregnancy with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 35 years old female patient who was exposed to vaccine Influenza quadrival A-B vaccine [Fluzone Quadrivalent] in context of vaccine exposure during pregnancy with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported vaccine exposure during pregnancy with no reported adverse event occurred at 14 weeks of pregnancy and the patient was exposed to Influenza quadrival A-B vaccine at 14 weeks of pregnancy, during first pregnancy trimester for Influenza quadrival A-B vaccine.  The date of last menstrual period was reported as 25-Jun-2022. The estimated due date is 31-Mar-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had not reported previous pregnancy/ies.   On 21-Sep-2022, the patient received a  dose of suspect Influenza quadrival A-B vaccine, suspension for injection (lot UT7682; dose, frequency, strength and expiry date not provided) via unknown route in the left deltoid for prophylactic vaccination.  On 21-SEP-2022 the patient had vaccine exposure during pregnancy with no reported adverse event (exposure during pregnancy).  Relevant prenatal testing after exposure was not reported.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event vaccine exposure during pregnancy with no reported adverse event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: U
Vaccine: DTAP, FLUX
Symptoms: Rash, Urticaria
Clinical narrative: rash that is similar looking to hives manifest on their face; Initial information received from on 23-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced rash that is similar looking to hives manifest on their face while receiving vaccines INFLUENZA VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, dose, route, administration site and lot number not reported) and a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (formulation, strength, dose, route, administration site and lot number not reported), both for prophylactic immunization.   On an unknown date, the patient developed a non-serious event of rash that is similar looking to hives manifest on their face (rash) (unknown latency) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and INFLUENZA VACCINE.  Action taken was not applicable for both the suspects.  It was not reported if the patient received a corrective treatment for the event (rash that is similar looking to hives manifest on their face).  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA400131, 2022SA392579, 2022SA400987, 2022SA400369, 2022SA400371, 2022SA400976, 2022SA401056, 2022SA400981 and 2022SA401104 (CLUSTER).   This case involves unknown gender elderly patient who was given expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] for with no reported adverse 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 INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA, exp date: 30-Jun-2022) via unknown route in unknown administration site for Immunization.  On an unknown date the patients developed a non-serious "received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event" (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.; Sender's Comments:  US-SANOFI-01288883: SAD20220921002678:
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired Fluzone High Dose given with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA392579(CLUSTER).  This case involves Elderly (of over 65 years) and unknown gender patient and expired fluzone high dose (INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE) given with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot UJ772AA, expiration date: 30-Jun-2022 in unknown administration site a s Immunization .  On an unknown date the expired fluzone high dose given with no reported adverse event (expired product administered) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was unknown if there were lab data/results available. It was unknown if  the company suspect product inappropriately used as per local Marketing authorization  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired Fluzone High Dose given with no reported adverse event).  At time of reporting, the outcome was Unknown for the event    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.