chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, 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) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Lot number: gh9694) 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 (booter), 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 "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound COVID occurred after negative test; Positive, notes: positive test 3 days post negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
Age: 56.0
Sex: F
Vaccine: COVID19, 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) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 56 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: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: ZOLOFT, start date: Nov2010, stop date: 24Feb2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2023) Positive, notes: I started Paxlovid the same day I tested positive for Covid; (Feb2023) negative, notes: I tested negative for Covid seven days after my positive test; (Feb2023) negative, notes: Symptoms returned three days after negative test; (24Feb2023) Positive, notes: I tested positive today. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course : vaccine received and other medication in 2weeks. Had a rebound case. She tested negative for Covid seven days after her positive test. She started Paxlovid the same day her tested positive for Covid. Took Paxlovid for five days with no lessening of her symptoms. Symptoms increased on day three of Paxlovid from mild to more severe. Tested negative on the seventh day after her positive test. Symptoms returned three days after negative test and she tested positive today. Also, world's worst metallic taste from Paxlovid, Yuck. she wouldn't take it again for this reason.
Age: 39.0
Sex: F
Vaccine: COVID19, 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 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 39 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: "Type II Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "recent foot fracture resulted in surgery" (unspecified if ongoing); "recent foot fracture resulted in surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested Positive; Positive, notes: positive Covid test 4 days after final dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "CKD stage 3a" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Feb2023 as dose 4 (booster), single (Batch/Lot number: unknown), 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 included: "Cvid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "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, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster) single (Batch/Lot number: unknown) at the age of 40 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 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 was not reported. There were no concomitant medications. Past drug history included: Dilaudid, reaction(s): "known allergies Dilaudid", notes: known allergies Dilaudid. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (received treatment for COVID-19 with Paxlovid on 15Feb2023 to 20Feb2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=moderna, Vaccine dose number=3 / Vaccine brand=Pfizer / BioNTech, Vaccine dose number=2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 4 (booster), single (Lot number: gh9903) at the age of 49 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: el3247), in left arm and on 03Feb2021 as dose 2, single (Lot number: en5318), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2021 as dose 3 (booster), single (Lot number: 071f21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "IgA nephropathy" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: egg" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2021, outcome "unknown", described as "Vaccine brand other=moderna, Vaccine dose number=3 / Vaccine brand=Pfizer / BioNTech, Vaccine dose number=2"; 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: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, 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) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 49 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 included: "Prediabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hypercholesteremia" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN (E.C.), start date: 12Oct2022; ROSUVASTATIN, start date: 01Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: (22Feb2023) Negative, notes: Covid test was negative on day 5 after completing paxlovid; (26Feb2023) Positive, notes: today 4 days after testing negative patient tested positive today. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 17Feb2023 to 22Feb2023.
Age: 74.0
Sex: M
Vaccine: COVID19, 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-month-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 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: "hypothyroid" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Feb2023) Positive; (Feb2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included administration of Paxlovid from 09Feb2023 to 13Feb2023 (as reported). The patient had no known allergies. It was reported that the patient received Pravastin from 01Jan2023 to 10Feb2023. Covid test came back positive after being negative 5 days after without symptoms of fever or pain or cough, just Sneezing.   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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right 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 included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid.  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.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 40 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 17Apr2021 as dose 2, single (Lot number: ER8727), in left arm and on 17Jan2022 as dose 3 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid (COVID 19 Treatment) from 19Feb2023 to 24Feb2023.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; dose 1-3 Pfizer / BioNTech, dose 4-5 Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 27Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16May2022 as dose 4 (booster), single (Lot number: 057M21A), in left arm and on 18Nov2022 as dose 5 (booster), single (Lot number: olot122A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "prediabetic" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "allergies with penicillin" (unspecified if ongoing); "allergies with sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16May2022, outcome "unknown", described as "dose 1-3 Pfizer / BioNTech, dose 4-5 Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 64.0
Sex: F
Vaccine: COVID19, 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) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right 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 included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. The patient has no known allergies.. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Five days after, symptoms returned with positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment from 15Feb2023 to 20Feb2023. 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. The patient had not recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), 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: DIZZINESS (non-serious), outcome "recovering", described as "Dizzy".  Additional Information: Reporter stated that the patient felt dizzy too but was better now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: 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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic bronchitis" (unspecified if ongoing). The patient had no known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxloid from 14Feb2023 to 19Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Lot number: AS87164B) at the age of 51 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 included: "High blood pressure" (unspecified if ongoing); "known allergies: X-ray die" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergies: morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 16Feb2023 to 20Feb2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia, Gastrooesophageal reflux disease, Hypoaesthesia, Myocarditis
Clinical narrative: myocarditis; Numb left arm and numb left leg; chest pain/Experienced very intense chest pain for some time; very intense heartburn; acid reflux; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "depression" (unspecified if ongoing); "mood disorders" (unspecified if ongoing). The patient had no known allergy. Concomitant medication(s) included: PROBIOTICS. Vaccination history included: pfizer-biontech (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 02Apr2021, when the patient was 24-year-old, for COVID-19 Immunization; pfizer-biontech (Dose Number: 2, Batch/Lot No: EW0176, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 23Apr2021, when the patient was 24-year-old, for COVID-19 Immunization; Pfizer-biontech (Dose Number: 3, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Route of Administration: Intramuscular), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "recovered with sequelae"; HYPOAESTHESIA (non-serious) with onset the same day of vaccination, outcome "recovered with sequelae", described as "Numb left arm and numb left leg"; CHEST PAIN (non-serious) with onset the same day of vaccination, outcome "recovered with sequelae", described as "chest pain/Experienced very intense chest pain for some time"; DYSPEPSIA (non-serious), outcome "recovered with sequelae", described as "very intense heartburn"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "recovered with sequelae", described as "acid reflux". The events "myocarditis", "numb left arm and numb left leg", "chest pain/experienced very intense chest pain for some time", "very intense heartburn" and "acid reflux" required physician office visit. Day after vaccination, the patient went to doctor that said symptoms were consistent with myocarditis. The patient experienced very intense chest pain for some time after booster was administered patient experienced very intense heartburn and acid reflux that they previously never had. Patient said chest pain symptoms will come and go moderately now.  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: F
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: she is disabled and her health has declined.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), 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: GENERAL PHYSICAL HEALTH DETERIORATION (disability), outcome "unknown", described as "she is disabled and her health has declined.". The patient had a problem with the vaccine and her health has declined after administering the vaccine then she was disabled.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 22-year-old male patient received BNT162b2 (BNT162B2 NOS), 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: MYOCARDITIS (hospitalization), outcome "recovered".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of MYOCARDITIS due to temporal relationship and current known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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 EMBOLISM (medically significant), outcome "unknown". The physician said he wasn't sure if it was caused by the vaccine, but he wondered. He said did not affect his belief in or usage of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of PULMONARY EMBOLISM due to temporal relationship.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I've had 5 Pfizer shotsm every booster you can get and I still got Covid; I've had 5 Pfizer shotsm every booster you can get and I still got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), . The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I've had 5 Pfizer shotsm every booster you can get and I still got Covid".  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.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Neuropathy peripheral, Type 2 diabetes mellitus
Clinical narrative: peripheral neuropathy; type two diabetes; hardly walk; 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 NOS), 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: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "peripheral neuropathy"; TYPE 2 DIABETES MELLITUS (medically significant), outcome "unknown", described as "type two diabetes"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "hardly walk".  Clinical course: After patient took the Covid shot when it came out patient almost gave up for being so patient will but kept on but patients medical condition was still bad patient have a real bad case of peripheral neuropathy where cannot hardly walk and patient have a type two diabetes.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance
Clinical narrative: can barely walk or go anywhere; with same problem with balance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "can barely walk or go anywhere"; BALANCE DISORDER (non-serious), outcome "unknown", described as "with same problem with balance".  Additional information: She stated that she got the Pfizer COVID vaccine and now her independence is gone. She can barely walk or go anywhere unless someone is with her. Another lady that got the vaccine at the same time as her has the same symptoms and also a friend of hers said the same thing. She's heard 3-4 others with same problem with balance, walking and everything. Her doctor has done all kinds of tests and nothing is coming up, so it must be the vaccine that did it. It is hard to do anything. She has gone from a cane to a walker. It's getting worse all the time. It's your stupid vaccine. It does damage to people. People got it and still got sick. She stated that she is very ticked off multiple times.She also said she's gonna do something about this and she is about to get a lawyer because her life is a mess.  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-202300051026 same reporter/drug/AE,different patient;
Sex: U
Vaccine: COVID19
Symptoms: Anaemia
Clinical narrative: anemic; WBC was 3.4 and has been dropping since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 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: WHITE BLOOD CELL COUNT DECREASED (non-serious) with onset May2021, outcome "unknown", described as "WBC was 3.4 and has been dropping since"; ANAEMIA (non-serious), outcome "unknown", described as "anemic". The events "anemic" and "wbc was 3.4 and has been dropping since" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anaemia, white blood cell count decreased.  Additional information: The patient's White Blood Count was 7.8 before the patient got the vaccine in early 2021. In May of 2021 the patient's WBC was 3.4 and has been dropping since. It reached 1.5 of Jan2023. The patient had to quit teaching job in summer of 2021 as an adjunct math instructor at College because the patient was anemic. The patient was seeing a hematologist and rheumatologist and was on Prednisone.  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: Aphasia, Confusional state, Decreased appetite, Headache, Investigation
Clinical narrative: Fevers; Headaches; Arm lifting up for no reason Pain; Loss of appetite; Loss of control to talk or move; Loss of control to talk or move; Loss of speech; Confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 21-year-old female patient received BNT162b2 (BNT162B2 NOS), 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: PYREXIA (hospitalization), outcome "unknown", described as "Fevers"; HEADACHE (hospitalization), outcome "unknown", described as "Headaches"; PAIN IN EXTREMITY (hospitalization), outcome "unknown", described as "Arm lifting up for no reason Pain"; DECREASED APPETITE (hospitalization), outcome "unknown", described as "Loss of appetite"; LOGORRHOEA (hospitalization), MOVEMENT DISORDER (hospitalization), outcome "unknown" and all described as "Loss of control to talk or move"; APHASIA (hospitalization), outcome "unknown", described as "Loss of speech"; CONFUSIONAL STATE (hospitalization), outcome "unknown", described as "Confused". The patient underwent the following laboratory tests and procedures: fevers: 100-103, notes: 100-103 every other day.  Clinical course: Patient took your pfizer shot last year, and now our little girl was in need of medical attention, Symptoms: Headaches Sizers Arm lifting up for no reason Pain Loss of appetite Loss of control to talk or move Loss of speech Confused Fevers from 100-103 every other day Plus many more. Taken to hospital every week on file.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Logorrhoea, Movement disorder, Pain in extremity, Pyrexia
Clinical narrative: Fevers; Headaches; Arm lifting up for no reason Pain; Loss of appetite; Loss of control to talk or move; Loss of control to talk or move; Loss of speech; Confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 21-year-old female patient received BNT162b2 (BNT162B2 NOS), 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: PYREXIA (hospitalization), outcome "unknown", described as "Fevers"; HEADACHE (hospitalization), outcome "unknown", described as "Headaches"; PAIN IN EXTREMITY (hospitalization), outcome "unknown", described as "Arm lifting up for no reason Pain"; DECREASED APPETITE (hospitalization), outcome "unknown", described as "Loss of appetite"; LOGORRHOEA (hospitalization), MOVEMENT DISORDER (hospitalization), outcome "unknown" and all described as "Loss of control to talk or move"; APHASIA (hospitalization), outcome "unknown", described as "Loss of speech"; CONFUSIONAL STATE (hospitalization), outcome "unknown", described as "Confused". The patient underwent the following laboratory tests and procedures: fevers: 100-103, notes: 100-103 every other day.  Clinical course: Patient took your pfizer shot last year, and now our little girl was in need of medical attention, Symptoms: Headaches Sizers Arm lifting up for no reason Pain Loss of appetite Loss of control to talk or move Loss of speech Confused Fevers from 100-103 every other day Plus many more. Taken to hospital every week on file.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Fatigue
Clinical narrative: heart problems; extremely fatigued/ fatigued kept going and felt it even more during work out/ super exhausted/ feeling of exhaustion lasts throughout the day; 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), on 01Mar2021 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: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "extremely fatigued/ fatigued kept going and felt it even more during work out/ super exhausted/ feeling of exhaustion lasts throughout the day"; CARDIAC DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "heart problems". The events "heart problems" and "extremely fatigued/ fatigued kept going and felt it even more during work out/ super exhausted/ feeling of exhaustion lasts throughout the day" required physician office visit.  Additional Information: It was reported that the patient would be requesting the doctor to be checked for heart problems. After receiving the vaccine, the patient felt extremely fatigued; the fatigue kept going and was felt even more when the patient worked out. The patient felt super exhausted when working out and that feeling of exhaustion lasted through out the day. The patient took the first dose on 01Mar2021 and went for the second dose on 23Mar2021. The patient asked the doctor questions regarding her symptoms and doctors dismissed them and said it was okay to get the 2nd dose. Patient has not received boosters.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: he died from coming down with Covid; he died from coming down with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "leukemia" (unspecified if ongoing), notes: Under unspecified treatment for leukemia. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (death, medically significant), SUSPECTED COVID-19 (death, medically significant), outcome "fatal" and all described as "he died from coming down with Covid". The patient date of death was unknown. Reported cause of death: "he died from coming down with Covid". It was not reported if an autopsy was performed. The reporter stated that he/she understands that chemotherapy and/or immunotherapy treatments may reduce or even eliminate the efficacy of vaccine, even if patient has had all 5 shots (including boosters). The reporter had just lost a friend who had been treated for leukemia when he died from coming down with COVID, even though he had "all of your vaccine shots".  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: he died from coming down with Covid; he died from coming down with Covid
Sex: F
Vaccine: FLUX
Symptoms: Gastric disorder
Clinical narrative: GI intolerance; Initial information regarding an unsolicited valid non-serious courtesy case received  via physician received on 23-Feb-2023.  This case involves elderly female patient who experienced gastrointestinal (GI) intolerance after receiving vaccine Influenza Vaccine (Flu Vaccine).  It was 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 received suspect Influenza Vaccine produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route, administration site) for prophylactic vaccination.  On an unknown onset and latency, the patient developed a non-serious GI intolerance (gastric disorder) following the administration of Influenza Vaccine.  Action taken with Influenza Vaccine (Flu 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.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received an expired dose of daptacel with no reported adverse event; Initial information received on 27-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who had patient received an expired dose of daptacel with no reported adverse event after receiving vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Feb-2023, the patient received a dose 5 0.5 ml once of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection lot C5816AA, expiration- 26-feb-2023 via intramuscular route in the left arm for immunisation.  On 27-Feb-2023 the patient developed a non-serious patient received an expired dose of daptacel with no reported adverse event (expired product administered) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  corrective treatment: not reported for the event (patient received an expired dose of daptacel with no reported adverse event).  Outcome: Unknown for the event patient received an expired dose of daptacel with no reported adverse 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 guidelines. 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.