chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
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 a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Dec2022 at 19:00 as dose 5 (booster), single (Lot number: GJ6738) at the age of 56 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), 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 was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 15Dec2011. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment with Paxlovid from 04Mar2023.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. 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), on 28Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 21Apr2021 as dose 2, single (Lot number: EW0170), in left arm, on 21Oct2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "bilateral mastectomy", start date: 2008 (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "slightly elevated cholesterol" (unspecified if ongoing), notes: genetic (medicated with rosuvastatin, this was paused during Paxlovid treatment + 2 Days). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment with Paxlovid from 04Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300119803 same reporter/patient; different dose/events;
Sex: M
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 48-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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". This case was reported as non-serious. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treated with PAXLOVID started from 16Mar2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2 NOS), on 20Oct2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 27Nov2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive, notes: Treatment of COVID-19; (17Mar2023) Negative; (18Mar2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The patient has no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old 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: "acid reflux" (unspecified if ongoing), notes: Stopped taking my acid reflux and my Omeprazole which is for my acid reflux, my acid reflux is almost resolved; "Eyesight" (unspecified if ongoing), notes: taking is Areds 2 multivitamins, which is for my eyesight. Concomitant medication(s) included: ATORVASTATIN; OMEPRAZOLE taken for gastrooesophageal reflux disease; AREDS 2 PLUS MULTI VITAMIN taken for eye disorder. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Mar2023, outcome "unknown" and all described as "COVID". The event "covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was taking Triology spray as concomitant medication where his dentist has recommended stating that it kills 99.9% of COVID-19 virus. It was sprayed in mouth or on hands and has been using it for all most for a year now. No investigations were done. The patient experienced COVID-19 on 14Mar2023 (Tuesday) evening, it just had some symptoms showed up and on 15Mar2023 (Wednesday), the patient contacted his doctor's office and one of his associates gave a prescription for Paxlovid and started to take it from 15Mar2023 (Wednesday) around 13:00 (1 o'clock) and took more on 15Mar2023 (Wednesday) evening just before the patient went to bed around 22:00 (10 o'clock).     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: Gait inability
Clinical narrative: I can't walk without assistance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization, reaction(s): "my feet and hands went numb". The following information was reported: GAIT INABILITY (disability), outcome "unknown", described as "I can't walk without assistance".  Additional information: The patient mentioned after Pfizer Covid vaccination, feet and hands went numb. After two more boosters, can't walk without assistance.  "Do you have any knowledge on how I can reverse this process and walk again?"  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300121944 same patient different dose/drug/event;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Computerised tomogram, Multiple sclerosis
Clinical narrative: She felt the COVID-19 vaccines made her MS worse; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient. Other Case identifier.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 25May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years for COVID-19 immunisation. The patient's relevant medical history included: "Allergy: Penicillin" (unspecified if ongoing); "Skin cancer" (unspecified if ongoing); "Lumps in right breast" (unspecified if ongoing), notes: Had outpatient procedures twice; "Irritable bowel disease" (ongoing), notes: Had it whole life; "60% hearing loss (left ear)" (unspecified if ongoing); "Double vision" (unspecified if ongoing); "Nerve damage in the right eye" (unspecified if ongoing); "Use glasses with prism" (unspecified if ongoing), notes: For double vision (nerve damage in the right eye); "Bowel problems" (unspecified if ongoing); "Bladder problems" (unspecified if ongoing), notes: Has to focus and push; "So many lesions on neck" (unspecified if ongoing), notes: About 20 lesions per CT scan; "So many lesions on spine" (unspecified if ongoing), notes: About 20 lesions per CT scan; "So many lesions on brain" (unspecified if ongoing), notes: About 20 lesions per CT scan; "Sleeping difficulty" (unspecified if ongoing); "Headaches once in a while" (unspecified if ongoing); "Occasional falls" (unspecified if ongoing), notes: Bouncing into the walls, trip up the steps; "Anxiety" (unspecified if ongoing); "MS" (ongoing), notes: Multiple family members with MS (from mother's side). Concomitant medications included: HYDROXYZINE; MELOXICAM; CANNABIDIOL. Vaccination history included: BNT162b2 (batch/lot number: unknown, as dose 1, single), administration date: 04May2021, when the patient was 55-year-old, for COVID-19 immunisation, reaction: "Made her MS worse". The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "She felt the COVID-19 vaccines made her MS worse". The patient underwent the following laboratory tests and procedures: Biopsy breast: Unknown result, notes: Past medical history; Computerised tomogram: About 20 lesions. Clinical course: The patient reported that she refused the booster because she felt the COVID-19 vaccines made her MS worse. Her doctor said that the COVID-19 vaccines would "probably" not help her, but recommended she get them.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300053297 same patient, drug, and event; different dose;
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: 014M20A), on 26Apr2021 as dose 2, single (Lot number: 047AZ1A), on 01Nov2021 as dose 3 (booster), single (Lot number: FH8U20) and on 22Apr2022 as dose 4 (booster), single (Lot number: 005M21A) for covid-19 immunisation. The patient's relevant medical history included: "BPH with urine retention" (unspecified if ongoing), notes: BPH with urine retention; "Osteoarthritis in both knees" (unspecified if ongoing), notes: Osteoarthritis in both knees. 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 "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment for the event included Paxlovid on 03Mar2023 to 08Mar2023.
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 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "No thyroid due to thyroid cancer" (unspecified if ongoing); "known allergies: Penicillin" (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 "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid, Pfizer COVID 19 Treatment from 09Mar2023 to 13Mar2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
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 non-contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Lot number: C-H9694) at the age of 62 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: "tinnitus in ears" (unspecified if ongoing), notes: Other medical history: tinnitus in ears; "arthritis in knees" (unspecified if ongoing), notes: Other medical history: arthritis in knees; "high homocysteine" (unspecified if ongoing), notes: Other medical history: high homocysteine. Concomitant medication(s) included: LOVASTATIN, start date: 07Nov2021, stop date: 12Mar2023; CENTRUM A TO ZINC taken for vitamin supplementation, start date: 01May2022, stop date: 22Mar2023; BABY ASPIRIN, start date: 03Jul2022, stop date: 22Mar2023. 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: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient had no known allergies.  No follow-up attempts are Possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162b2, BNT162b2 omi ba.4-5  vaccine can not be excluded for the reported events of COVID-19 and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, 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 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2021 as dose 4 (booster), single (Lot number: gj6742) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: el3247), in left arm, on 16Mar2021 as dose 2, single (Lot number: el3247), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: fj8762), 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". 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.
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (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), 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: "Heart disease" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medications included: EZETIMIBE, start date: 01Sep2022, stop date: 12Mar2023; HYDROCHLOROTHIAZIDE, start date: 01Nov2016, stop date: 13Mar2023; LISINOPRIL, start date: 01Nov2016; ROSUVASTATIN, start date: 01Nov2016, stop date: 12Mar2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" 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 drug ineffective, COVID-19 which included Paxlovid from 12Mar2023 to 17Mar2023.  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: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain
Clinical narrative: soreness and stinging during the time of administration; arm is still sore; red circle on the injection site/a red circle probably 2-3 inches around; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 15Mar2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2023, outcome "not recovered", described as "arm is still sore"; VACCINATION SITE ERYTHEMA (non-serious) with onset Mar2023, outcome "unknown", described as "red circle on the injection site/a red circle probably 2-3 inches around"; VACCINATION SITE PAIN (non-serious) with onset 15Mar2023, outcome "recovered", described as "soreness and stinging during the time of administration".  Additional information: Caller reported that she received Prevnar 20 and there was a red circle on the injection site, soreness and stinging during the time of administration (she clarified that it was not stinging now, only when she received the injection) "when they gave it stung, this was really stinging", "She didn't know if it has been red ever since, but this morning it's big, around 2-3 inches in circumference." Caller wanted to know if those were normal. Caller confirmed that this was her first pneumococcal vaccine. Caller asked if it is okay for her to take SHINGRIX (for shingles) injection this coming April.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 09Jan2021 as dose 2, single (Lot number: EL1283), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 02Mar2020; DILTIAZEM, start date: 15Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Mar2023) Negative; (20Mar2023) Negative; (21Mar2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 66.0
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) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 26Mar2021 as dose 2, single (Lot number: ER8733), in left arm, on 02Oct2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "microscopic colitis" (unspecified if ongoing), notes: microscopic colitis. Concomitant medication(s) included: ALENDRONATE, start date: 09Dec2021; ROSUVASTATIN, stop date: 09Dec2021; GLUCOSAMINE & CHONDORITIN; COENZYME Q10+; CALCIUM CITRATE WITH VITAMIN D; LUTEIN-ZEAXANTHIN; and MULTIVITAMINS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of vaccination failure, covid-19. Outcome of the events was unknown.
Age: 36.0
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) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jul2022 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 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: "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Vertigo" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: VENLAFAXINE, start date: 12Apr2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 16Sep2020; FLONASE [FLUTICASONE PROPIONATE], start date: 13Jul2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: first negative test two days later,; (Mar2023) Positive, notes: I recorded two positive rapid tests; (Mar2023) Positive, notes: I recorded two positive rapid tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient stopped taking Paxlovid street the second day (treated with PAXLOVID from 13Mar2023 to 15Mar2023) as patient developed severe diarrhea and some vomiting. Patient received her first negative test two days later, then 7 days after Paxlovid patient started having a sore throat, fatigue, and body aches so she tested for COVID-19. She recorded two positive rapid tests.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: 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 (Nurse). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 30Dec2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in right 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 09Mar2023 to 13Mar2023.  Clinical course: The patient finished Paxlovid on the 13th - felt better. Started getting symptomatic again on 20Mar2023. The patient has no known allergies.  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 available information, the reported serious events cannot be excluded for the suspect drug BNT162b2.  The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.
Age: 67.0
Sex: F
Vaccine: 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 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication included: NP THYROID, start date: Apr2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, 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 from 12Mar2023 To 16Mar2023 as treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
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). The reporter is the patient. A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunization; 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 immunization. The patient had no relevant medical history. Concomitant medication(s) included: BUPROPION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Mar2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective and covid-19. Clinical information: It was reported that the patient had positive COVID-19 test on 22Mar2023. The patient then received PAXLOVID as treatment on 09Mar2023 until 14Mar2023.  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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Caller and her husband had Covid vaccines are the same day except for one.; Caller and her husband had Covid vaccines are the same day except for one.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 71 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6202, Expiration Date: Jun2021), on 21Mar2021 as dose 2, single (Lot number: ER8727, Expiration Date: Jul2021), on 17Aug2021 as dose 3 (booster), single (Lot number: EWO172) and on 08Apr2022 as dose 4 (booster), single (Lot number: FP4554) for covid-19 immunisation. The patient's relevant medical history included: "stent in heart", start date: Jul2016 (not ongoing); "high blood pressure" (unspecified if ongoing); "Blood cholesterol abnormal" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller and her husband had Covid vaccines are the same day except for one.". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Reporter's husband. Reporter knows there are only 2-4% of rebound cases, but she happened to be one of them. Calling to report. This was happened to herself and her husband. This report was for reporter's husband. Reporter and her husband had Covid vaccines are the same day except for one. He had different symptoms than reporter , but they got sick at the same place. He was on high blood pressure and cholesterol medication. Had been taking Coricidin High Blood Pressure. He was really healthy. Reporter's dad has had three open heart surgeries so reporter watches what her husband eats. The vaccines given and they didn't put any expiration. Reporter and her husband had a harder time getting the vaccines. Yes there was a product complaint to report. sample of the product was available to be returned, if requested: not provided. Packaging sealed and intact: not provided. Consumer, patient, caregiver: not provided.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300128478 Same patient, different product, different event;US-PFIZER INC-202300128590 same reporter/product, different patient/events;US-PFIZER INC-202300128494 same reporter/product, different patient/events;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive/Treatment of COVID-19; Tested positive/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 female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 67 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6202, Expiration Date: Jun2021), in right arm, on 21Mar2021 as dose 2, single (Lot number: ER8727, Expiration Date: Jul2021), in right arm, on 16Aug2021 as dose 3 (booster), single (Lot number: EW0172), in right arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FP4554), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild case asthma" (unspecified if ongoing), notes: diagnosed 6 years ago when her cats came into her life., Takes Dulera 100mcg/5mcg, one puff.; "High Blood Pressure" (unspecified if ongoing); "keep iron up" (unspecified if ongoing). Concomitant medication(s) included: IRON taken for blood iron decreased, start date: Oct2022 (ongoing); VITAMIN D [COLECALCIFEROL] (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Mar2023, outcome "unknown" and all described as "Tested positive/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Mar2023) positive; (17Mar2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes: Coricidin High Blood Pressure, tried Mucinex maximum strength and Mucinex Sinus Max that did not work.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300128503 same reporter, product and event, different patient;
Age: 60.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years 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: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. 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; patient was given 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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: fully vaccinated and two booster shots and month later with UH COVID-19; fully vaccinated and two booster shots, month later with UH COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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), 1 month after the suspect product(s) administration, outcome "unknown", described as "fully vaccinated and two booster shots and month later with UH COVID-19"; SUSPECTED COVID-19 (medically significant), 1 month after the suspect product(s) administration, outcome "unknown", described as "fully vaccinated and two booster shots, month later with UH COVID-19".  Clinical course: Patient wanted to file a complaint.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 47 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 20Apr2021 as dose 2, single (Lot number: EW0162), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: FJ8757), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: SARS-CoV-2 test: (22Mar2023) Positive, notes: Positive Covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient. A 17-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 15:30 as dose 4 (booster), single (Lot number: GH9702) at the age of 17 years, in left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 21May2021 as dose 1, single (Lot number: EN6205), in left arm, on 07Jul2021 as dose 2, single (Lot number: GW0171), in left arm and on 06Jan2022 as dose 3 (booster), single (Lot number: FJ8757), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Known allergies: Medicine" (unspecified if ongoing); "Joint hyper mobility" (unspecified if ongoing); "amplified musculoskeletal pain" (unspecified if ongoing); "scoliosis" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "IBS" (unspecified if ongoing); "WPW" (unspecified if ongoing); "asthma" (unspecified if ongoing); "dysautonomia" (unspecified if ongoing); "alopecia" (unspecified if ongoing); "eczema" (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 12Mar2023, outcome "recovered" (18Mar2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Mar2023) Negative; (12Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient was tested positive for COVID on 12Mar2023. She started PAXLOVID as treatment on 13Mar2023 and took all 5 days of the treatment. She tested negative on 18Mar2023 and on 19Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300128804 Same patient/drug, different dose number and event;
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8277), in right arm, on 14Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 07Sep2021 as dose 3 (booster), single (Lot number: FE3592), in right arm for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "Osteo Arthritis" (unspecified if ongoing). The patient has no known allergies. 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 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Had a massive heart attack; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series completed, unknown manufacturer), for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "Had a massive heart attack". The patient date of death was unknown. Reported cause of death: "Had a massive heart attack". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Had a massive heart attack
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 19Nov2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 14Jun2022 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing). The patient's concomitant medications were not reported. No known allergies. The following information was reported: 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 which includes Paxlovid (COVID 19 Treatment) from 20Mar2023 to 21Mar2023.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 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: "Post concussion syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Mar2023) Negative, notes: Took antigen tests and was negative on Monday; (21Mar2023) Negative, notes: Took antigen tests and was negative on Tuesday; (23Mar2023) positive, notes: tested again at home Thursday and was positive. 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: Linked Report(s) : US-PFIZER INC-202300128879 Same patient, different drug, different event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. 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.