chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Positive for Covid-19; Positive for Covid-19; Moderna - Dose number: 5 ... Pfizer / BioNTech - Dose number: 3; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 12:00 as dose 1, single (Lot number: El9266), in right arm, on 25Mar2021 at 12:00 as dose  2, single (Lot number: Er8732), in right arm and on 15Oct2021 as dose 3 (booster), single (Lot number: Ff2587) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09May2022 as dose 4 (booster), single (Lot number: 049l21a), in left arm and on 27Sep2022 at 10:00 as dose 5 (booster), single (Lot number: AS7163B CUS9951), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Feb2021, stop date: 30Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Positive for Covid-19 "; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna - Dose number: 5 ... Pfizer / BioNTech - Dose number: 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (07Oct2022) Negative; (11Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient tested positive for Covid-19 on an unknown date and was treated with Paxlovid from 30Sep2022 to 04Oct2022. The patient tested positive again for Covid-19 on 11Oct2021.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable consumer.  A 67-year-old male patient received BNT162b2 (BNT162B2), 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 included: "Diabetes" (unspecified if ongoing), notes: Underlying issues; "High blood pressure" (unspecified if ongoing), notes: Underlying issues. The patient took concomitant medications. The patient takes unspecified medicines for diabetes, high blood pressure, and other medicines. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for 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 nirmatrelvir/ritonavir (PAXLOVID) from 06Oct2022. Per clinical course, the patient and his wife had been so sick with whatever variant they got, and the wife successfully did not get COVID-19 (patient's wife was healthy). The patient and his wife were due for the booster and on the day, they were to get the vaccine, the patient got positive for COVID-19. The patient didn't know what was making him feel so bad. The patient needed the booster (as he is a PharmD in a hospital and university). When the patient's wife reported to her doctor's office last Thursday, the patient was positive the day before. The patient's wife stated why the hospital was not even worried and everyone in the pharmacy is coming down with COVID-19. The patient's coworker has this now and the people that worked here. The patient's wife was waiting for the Bivalent and the hospitals should vaccinate employees; she was waiting for the Bivalent and wasn't worried about COVID-19. The patient was 13 months out from his last booster and that didn't do him any good and the patient's wife was 10 months out. The patient has his vaccination card and probably had different vial. That's how the patient's wife got her vaccinations and don't think have same lot. The patient might have had 2 boosters and the wife was not sure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: DIAG: COVID; DIAG: COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  An 84-year-old patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) 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 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 "DIAG: COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: DIAG: C0VID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient was prescribed Paxlovid on 01Sep2022 after experiencing slight sore throat, cough, nose drizzles. Diag: Covid. According to the patient, "4th day, I experienced (while standing) a situation in which I had a dry feeling up and down my airway and I had to breathe and choke for breath for several seconds. My airway felt completely dried out is how I can explain it. It is a sensation of gasping I have never had before. It then cleared after several seconds of gasping. I am fully vaccinated and double-boosted. Age 84".   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: Balance disorder, Migraine, Peripheral swelling, Pyrexia
Clinical narrative: migraine; fever; swollen arm 3 out of 4 times; feeling off balance for 3 days; 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 73-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (ongoing); "congenital heart defect" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling off balance for 3 days", "Migraine", "swollen arm", "fever"; Bnt162b2 (dose 2, Batch/Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling off balance for 3 days", "Migraine", "swollen arm", "fever". The following information was reported: MIGRAINE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen arm 3 out of 4 times"; BALANCE DISORDER (non-serious), outcome "recovered", described as "feeling off balance for 3 days".  Additional information: The reporter (consumer, patient) stated she has had many side effects from her previous four doses of the Pfizer BioNTech COVID-19 Vaccine: "migraine, fever, swollen arm 3 out of 4 times, and feeling off balance for 3 days." She asked if there were any other side effects that are different with the new bivalent booster compared to the original. She also asked what ingredients are different in the new bivalent vaccine.  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-2021432814 same reporter/patient, different dose number/events;
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Swelling face, Vaccination site swelling
Clinical narrative: difficulty breathing; Swelling of the face and at the injection site; Swelling of the face and at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN; Lot number: unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN; Lot number: unknown), for COVID-19 Immunization. The following information was reported: SWELLING FACE (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset Oct2022, outcome "unknown" and all described as "Swelling of the face and at the injection site"; DYSPNOEA (non-serious) with onset Oct2022, outcome "unknown", described as "difficulty breathing".  Additional information: Patient just wanted to report the reactions she had with the booster. She took the booster on 06Oct this year (Later clarified as 06Oct2022). She had difficulty breathing, swelling of the face and at the injection site. The Pfizer, she took the other 4 (Further clarifications unknown) and this was the third booster. Call got disconnected. Call back was done to gather more information however unsuccessful. Thus, further probing was not done. Product details (NDC# and UPC#) and Pharmacy details could not be probed. Hence limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Malaise
Clinical narrative: Not to feel well and he had to sit down in shower, usually stands; Ongoing shortness of breath with exertion; continues to shortness of breath with exertion; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): UNT-2022-022833.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation; treprostinil sodium (TYVASO), since 26Sep2022 (Lot number: 000276P, Expiration Date: 30Sep2023) at 16 ug 4x/day for pulmonary arterial hypertension; treprostinil (TREPROSTINIL), since 26Sep2022 (Batch/Lot number: unknown) at 16 ug 4x/day, nasal for pulmonary arterial hypertension. The patient's relevant medical history included: "Primary pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: TADALAFIL; ELIQUIS; OPSUMIT. Vaccination history included: Bnt162b2 (Dose 1, Ongoing shortness of breath with exertion; continues to shortness of breath with exertion), for COVID-19 immunization, reaction(s): "Ongoing shortness of breath with exertion; continues to shortness of breath with exertion"; Bnt162b2 (Dose 2, Ongoing shortness of breath with exertion; continues to shortness of breath with exertion), for COVID-19 immunization, reaction(s): "Ongoing shortness of breath with exertion; continues to shortness of breath with exertion". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Not to feel well and he had to sit down in shower, usually stands"; DYSPNOEA EXERTIONAL (non-serious), outcome "not recovered", described as "Ongoing shortness of breath with exertion; continues to shortness of breath with exertion". The action taken for treprostinil sodium and treprostinil was unknown.  Additional information: On an unreported date in Sep2022, the patient had ongoing shortness of breath with exertion (dyspnoea exertional). On 04Oct2022 he received his 3rd COVID booster. On 05Oct2022, 10 days after initiating Tyvaso, he was not feeling well and he had to sit down in shower, usually stands (malaise). The reporter did not provide the causality for the event of dyspnoea exertional. The reporter did not provide causality for the event of malaise. The reporter's causality for the event of malaise with COVID-19 vaccine was considered to be possibly related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 05Apr2021 as dose 2, single (Lot number: EP7534), in right arm and on 29Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: indication=Treatment of COVID-19; (28Sep2022) Positive, notes: this was my 1st positive COVID test on 28Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter (consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER2613), in left arm and on 12Apr2021 as dose 2, single (Lot number: EW0158) at the age of 31 years, in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Dec2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medications included: CITALOPRAM, start date: Oct2016; HYDROXYZINE, start date: Jan2018. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid rebound 5 days after testing negative; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The patient received COVID 19 Treatment which included Paxlovid from 02Oct2022 to 06Oct2022 (lot number: 1918538A). The patient reported Covid rebound 5 days after testing negative on 11Oct2022, not recovered. There was no treatment. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Vaccination site pain
Clinical narrative: Chills (recovered), pain at site of injection, body aches, tiredness; Chills (recovered), pain at site of injection, body aches, tiredness; Chills (recovered), pain at site of injection, body aches, tiredness; Chills (recovered), pain at site of injection, body aches, tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 52-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 (Lot number: GJ6742) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 14Sep2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Dose: 3 (1st booster), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 10Oct2022, outcome "recovered" (2022), VACCINATION SITE PAIN (non-serious), PAIN (non-serious), FATIGUE (non-serious) all with onset 10Oct2022, outcome "recovering" and all described as "Chills (recovered), pain at site of injection, body aches, tiredness". Therapeutic measures were taken as a result of chills, vaccination site pain, pain, fatigue.  Additional information: Patient received more than 3 dose. Flu vaccine received in four weeks on 14Sep2022. Patient received treatment with Tylenol. Patient had no covid prior vaccination and not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
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) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 34 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: "known allergies Sulfa antibiotics" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from unspecified date in Oct2022 to 04Oct2022. Clinical course: Other medication in two weeks includes amlodipine besylate started on 03Oct2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 39.0
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 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), on 16Dec2021 at 12:00 as dose number unknown, single (Lot number: Fe3594) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Blood clotting disorder" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: percocet, reaction(s): "Known allergies: percocet". 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.
Age: 54.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: FM6704), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8734), in left arm, on 04Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 21May2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Bovine allergy" (unspecified if ongoing); "dairy allergy" (unspecified if ongoing). Concomitant medications included: BIOGEN [THIAMINE DISULFIDE]; GABAPENTIN; TYSABRI.  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; Positive notes: 6 days after stopping 5 day course of paxlovid Covid returned. Therapeutic measures were taken as a result of covid-19 which included Paxlovid (lot number: GE1577) from 30Sep2022 to 05Oct2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201223653 same patient/reporter, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid".  Clinical course: The report was not related to a study or programme. The patient was not the reporter. During report, caller mentions her fiance also got Covid and had gotten the Pfizer Covid 19 vaccine. Stated he is fine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Investigation, Pyrexia
Clinical narrative: fever of 101.6; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4362815.  A 32-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history included: "PML" (unspecified if ongoing), notes: Positive for PML; "Colitis" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing); "Ovarian Cysts" (unspecified if ongoing); "Shingles" (unspecified if ongoing); "Wheelchair Bound" (ongoing); "Right drop foot" (ongoing); "Migraines" (ongoing); "Vertigo" (ongoing); "Walker use" (ongoing); "Multiple sclerosis" (ongoing); "Asthma" (ongoing); "Yearly Seasonal Allergies" (ongoing); "Cat Dander Allergy" (ongoing); "Multiple Sclerosis Pain" (ongoing); "Mango Allergy" (ongoing); "Artificial Sweetener Allergy" (ongoing); "Panic Attacks" (ongoing); "Costochondritis" (ongoing); "Depression" (ongoing); "Leg Spasms" (ongoing); "Anxiety" (ongoing); "Nausea" (ongoing); "Lack of appetite" (ongoing); "Loss of dexterity in right hand" (ongoing); "Heart Burn" (ongoing). Concomitant medication(s) included: ALLERGA; FLOVENT; FLONASE [MOMETASONE FUROATE]; PANTOPRAZOLE; LYRICA; MECLIZINE [MECLOZINE]; TIZANIDINE; ESCITALOPRAM; PROCHLORPERAZINE; SUMATRIPTAN; GABAPENTIN; NUVARING. Past drug history included: Macrobid, reaction(s): "Macrobid Allergy"; Golytely, reaction(s): "Golytely Allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; pain was a 6-7/10, temporal areas on both sides, sharp pain that was really annoying), administration date: 26Mar2021, when the patient was 32-year-old, for Covid-19 immunization, reaction(s): "Sharp Pain", "headache", "chills", "100 degree fever". The following information was reported: PYREXIA (non-serious) with onset 16Apr2021, outcome "recovered", described as "fever of 101.6". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had received 4 different doses of the Pfizer Covid vaccine. She received the initial vaccine 26Mar2021, and the second dose was on 16Apr2021. Her first booster was on 14Oct2021, and her most recent booster was on 23Sep2022.  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-PV202200074210 same reporter/patient/event, different dose number;
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: esophageal acid reflux; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003618 (Novavax).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "esophageal acid reflux".  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: Cerebrovascular accident
Clinical narrative: Had a stroke; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization completed Unknown manufacturer), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had a stroke".  Clinical information: The patient received 3rd dose of vaccine and had a stroke. Dr. said that he believes the event was attributable to the vaccine. The event happened after his third dose. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and the event cerebrovascular accident cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse event,s. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Dyspnea; This is a spontaneous report received from contactable reporter(s) (Physician), Program ID.  A 47-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Acetaminophen, reaction(s): "Reactions: Rash"; Amoxicillin, reaction(s): "Reactions: Bleeding"; Hydrocodone-acetaminophen, reaction(s): "Reactions: Hives"; Oxycodone-acetaminophen, reaction(s): "Reactions: Rash"; Simvastatin, reaction(s): "Reactions: Myalgia". The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Dyspnea".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: MNQ, UNK
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event, Wrong product administered
Clinical narrative: The patient was to receive Meninge B and received a 3rd dose of Menactra approximately 1 year after the 2nd dose of Menactra with no reported adverse event; The patient was to receive Meninge B and received a 3rd dose of Menactra approximately 1 year after the 2nd dose of Menactra with no reported adverse event; Initial information received on 06-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adolescent female patient who was to receive meninge b (MENINGOCOCCAL VACCINE B) and received a 3rd dose of menactra (MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]) approximately 1 year after the 2nd dose of menactra with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE Solution for injection (strength, dose and lot number not reported) via intramuscular route in unknown administration site instead of MENINGOCOCCAL VACCINE B, for prophylactic vaccination.  On an unknown, (latency: same day) date the patient developed a non-serious the patient was to receive meninge b and received a 3rd dose of menactra approximately 1 year after the 2nd dose of menactra with no reported adverse event (wrong product administered) and (inappropriate schedule of product administration).  Action taken was not applicable with both the suspects.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who had expired vaccine administered with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (formulation, strength, dose, route and administration site not reported) (lot UT7325MA and expiry date: 30-Jun-2022) for prophylactic vaccination.  On 03-Oct-2022, (latency: same day) the patient had expired vaccine administered with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  2022SA409871:
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: had a rash on her torso for 6 months following this; Initial information received on 06-Oct-2022 regarding an unsolicited valid non-serious case received from a patient.  This case involves an elderly female patient who had a rash on her torso for 6 months following this after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On an unknown date in 2017, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer at an unknown dose (strength, frequency, formulation, lot and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a rash on her torso for 6 months following this (rash) (unknown latency) following the administration of influenza vaccine.  It was reported stated she had a reaction that went on for half a year and she is debating whether or not it is safe for her to take the flu vaccine this year. she received a Sanofi flu vaccine in 2017 (not sure which one) and had a rash on her torso for 6 months following this. She states that this was reported to us and she spoke with a Sanofi medical doctor including several correspondence. She states that the Sanofi Medical Doctor advised her to not get another Sanofi flu vaccine. She states that this is going to be a bad year for the flu and asks if we would recommend that she get another Sanofi flu vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: nurses mistakenly administered FLUZONE QUDRIVALENT to a patient instead of COVID vaccine with no adverse event; Initial information was received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of age Under 35 years old and unknown gender who was reported with nurses mistakenly administered influenza quadrival A-B vaccine [Fluzone QIV] to a patient instead of covid vaccine with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a suspect influenza quadrival A-B vaccine suspension for injection at a dose of 0.5 ml once (expiry date and strength: unknown) lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the nurses mistakenly administered influenza quadrival A-B vaccine to a patient instead of covid vaccine with no adverse event (wrong product administered) (unknown latency) following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR3
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received an expired dose of flubok today with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] today with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Oct-2022, the patient received a expired dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (dose, strength, formulation and lot number: unknown) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (latency: same cay)  No lab data was reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue
Clinical narrative: Nurse attempted to administer a FLUZONE QIV NP pre-filled syringe into a patient's right arm and all of the medication leaked from the barrel of the syringe onto the patient's arm with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 38 years old female patient and the  nurse attempted to administer a fluzone qiv np pre-filled syringe into a patient's right arm and all of the medication leaked from the barrel of the syringe onto the patient's arm with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation: prefilled syringe, strength: unknown) lot UT7689JA, expiration date: 30-Jun-2023 via intramuscular route in the right arm for Influenza.  On 07-OCT-2022 the nurse attempted to administer a fluzone qiv np pre-filled syringe into a patient's right arm and all of the medication leaked from the barrel of the syringe onto the patient's arm with no reported adverse event (accidental exposure to product) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Administering Nurse states that the needle did not click as it normally does when applied to the pre-filled syringe. Patient did not receive any of the dose and FLUZONE QIV NP was re-administered. Leaking occurred during injection and from the bottom of the syringe barrel. PTC First Noticed : 2022-10-07 .PTC assessment medical/Physical : Medical  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Nurse attempted to administer a FLUZONE QIV NP pre-filled syringe into a patient's right arm and all of the medication leaked from the barrel of the syringe onto the patient's arm with no reported adverse event).  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient received IPOL from a punctured vial after it was exposed to a temperature excursion with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient received  IPV (VERO) [IPOL] from a punctured vial after it was exposed to a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Aug-2022, the patient received 0.5 ml dose of suspect IPV (VERO), suspension for injection from a punctured vial (lot V1B901M; Expiration Date :22-Jun-2024)  via unknown route in unknown administration site for immunization after it was exposed to a temperature excursion with no reported adverse event (poor quality product administered) (latency; same day). This situation occurred due to fridge malfunction Max/Low Temperature reached 16.6C, 8.9C, +9.6C, +8.6C, +12.8C for 1st excursion 6 HOURS and 17 MINUTES 2nd excursion 23 MINUTES 3rd excursion 15 MINUTES 4th excursion 8 MINUTES 5th excursion 6HOURS and 16 MINUTES. Human error was not involved.  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient received IPOL from a punctured vial after it was exposed to a temperature excursion with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA416564, 2022SA416822, 2022SA417045, 2022SA418179, 2022SA419029 and 2022SA418179.  This case involves a 4 years old female patient received IPV (VERO) [IPOL] from a punctured vial after it was exposed to a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Sep-2022, the patient received 0.5 ml dose of suspect IPV (VERO), suspension for injection from a punctured vial (lot V1B901M; Expiration Date :22-Jun-2024) via unknown route in unknown administration site for immunization after it was exposed to a temperature excursion with no reported adverse event (poor quality product administered) (latency; same day).  This situation occurred due to fridge malfunction Max/Low Temperature reached 16.6C, 8.9C, +9.6C, +8.6C, +12.8C for 1st excursion 6 HOURS and 17 MINUTES 2nd excursion 23 MINUTES 3rd excursion 15 MINUTES 4th excursion 8 MINUTES 5th excursion 6HOURS and 16 MINUTES. Human error was not involved.  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: extreme pain; soreness in left arm; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 69 years old female patient who was having extreme pain and soreness in left arm while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot number not reported via intramuscular route in the left arm as Immunization  On 07-SEP-2022 the patient had extreme pain (pain in extremity) soreness in left arm (myalgia) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that pain and soreness was there in left arm and inside of arm coming down to elbow and into left shoulder.  Action taken was not applicable.  The patient was treated with PARACETAMOL (TYLENOL)  and IBUPROFEN (IBUPROFEN) for Myalgia and Pain in extremity.  At time of reporting, the outcome was Not Recovered / Not Resolved for all.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood culture, Blood lactic acid, C-reactive protein, Cellulitis, Computerised tomogram head
Clinical narrative: Malignant Otitis Externa with facial cellulitis with no history of the same and no notable hyperglycemia. Not on Insulin.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Full blood count, Metabolic function test, Otitis externa, Procalcitonin, Red blood cell sedimentation rate
Clinical narrative: Malignant Otitis Externa with facial cellulitis with no history of the same and no notable hyperglycemia. Not on Insulin.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Tinnitus
Clinical narrative: On Oct 10, I took my 2nd covid booster with Pfizer (the updated version) on my left arm. Afterwards I developed titinus in my left ear,  the ringing is so loud & it has been non-stop until now (Oct 14).  I went to ENT & had hearing test, I currently experienced  hearing loss in my left ear. The doctor prescribed me prednisone.  I?m a perfectly healthy female & didn?t have any underlying conditions.  I also  experienced swollen lymph nodes  from my 2nd vaccine & 1st  booster.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Feeling jittery, Poor quality sleep, Sleep disorder, Tinnitus
Clinical narrative: Unable to sleep and restless. Had the vaccine at 11:45 am. It is now 5:00 am the next day, and I am wide awake and jittery. With ringing in my ears and a slight temp.  The main complaint is the inability to sleep.