chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: 08/29/23: PATIENT CALLED REPORTING SHE STILL HAS REDNESS, INFLAMMATION, ITCHINESS (AT TIMES) AND SORENESS ON THE INJECTION SITE. PATIENT RECEIVED RSV VACCINE ON 08/10/23, NO OTHER SIDE EFFECTS EXPERIENCED ASIDE FROM LOCAL SITE REACTION. DENIED ANY SYSTEMIC SYMPTOMS.   -local site reaction has lasted for 19 days already.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Local reaction
Clinical narrative: 08/29/23: PATIENT CALLED REPORTING SHE STILL HAS REDNESS, INFLAMMATION, ITCHINESS (AT TIMES) AND SORENESS ON THE INJECTION SITE. PATIENT RECEIVED RSV VACCINE ON 08/10/23, NO OTHER SIDE EFFECTS EXPERIENCED ASIDE FROM LOCAL SITE REACTION. DENIED ANY SYSTEMIC SYMPTOMS.   -local site reaction has lasted for 19 days already.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling face
Clinical narrative: facial swelling
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: 7 months pregnant, received booster dose. Baby was born at term with healthy weight. Night following the vaccination I woke in the middle of the night with very sore hands.  This continued every night for the duration of my pregnancy. The symptoms are now less but I continue to have sore hands during the night and upon waking and when driving, taking photos and other activities that require steady use of my hands.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: It was discovered after vaccination that the vaccine was expired. It was pulled from the freezer on 6/23 and is only valid for 30 days at refrigeration. Patient did not report any adverse event.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: It was discovered after vaccination that the vaccine was expired. It was pulled to the fridge on 6/23 and is only valid for 30 days at refrigeration. Patient did not report any adverse effects.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who received 1st dose of shingrix more than a year ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received more than a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient who received 1st dose of shingrix more than a year ago).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date: 23-AUG-2023 The pharmacist had a immunocompetent patient and would like to know if the series need to be restarted. No details of patient or vaccine available            The reporter consented to follow up.    Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: a dose of Engerix-B that had expired on 29/Apri/2023 was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number 7XY23, expiry date 29-APR-2023) for prophylaxis.   On 23-AUG-2023, the patient received the 3rd dose of Engerix B. On 23-AUG-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: a dose of Engerix-B that had expired on 29/Apri/2023 was administered to a patient).The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-AUG-2023 The reporter was a medical assistant. The reporter called to inform that earlier that day, a dose of Engerix-B that had expired and administered to a patient, which led to expired vaccine used.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: probably reconstituted with sterile water and administered to a patient; probably reconstituted with sterile water and administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 44HD4, expiry date 30-MAY-2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: probably reconstituted with sterile water and administered to a patient) and inappropriate dose of vaccine administered (Verbatim: probably reconstituted with sterile water and administered to a patient).The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt Date: 23-AUG-2023 The reporter called to inform that during inventory registration, it was discovered that a Shingrix diluent was left with no antigen, which lead them to think that Shingrix was probably reconstituted with sterile water and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter agreed to follow up by e-mail.
Age: 21.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a patient had accidentally received a dose of Infanrix despite being an adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 21-year-old female patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis.   On 24-AUG-2023, the patient received Infanrix. On 24-AUG-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a patient had accidentally received a dose of Infanrix despite being an adult).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 24-Aug-2023 Partial information about event, patient and vaccine was given. The vaccine administration facility was the same as Primary Reporter The medical assistant called in to report that a patient had accidentally received a dose of Infanrix despite being an adult, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: her left arm was sore; started having diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-AUG-2023, the patient received the 2nd dose of Shingrix (injection, left deltoid). In AUG-2023, an unknown time after receiving Shingrix, the patient experienced diarrhea (Verbatim: started having diarrhea). On 23-AUG-2023, the patient experienced pain in arm (Verbatim: her left arm was sore).The outcome of the pain in arm and diarrhea were not resolved.   It was unknown if the reporter considered the pain in arm and diarrhea to be related to Shingrix.   It was unknown if the company considered the pain in arm and diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-AUG-2023 The patient received Shingrix vaccine. The reporter stated that one day after receiving the vaccine her left arm was sore and she started having diarrhea. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Delusion, Stress, Suspected COVID-19
Clinical narrative: DELUSIONAL AND CRAZY; SUSPECTED COVID-19; GOT SOME FAR OFF STRAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 2023, the patient experienced suspected covid-19, and got some far off strain. On an unspecified date, the patient experienced delusional and crazy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from delusional and crazy, and the outcome of suspected covid-19 and got some far off strain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: SLOWLY STARTED LOSING TASTE /  TASTE DISAPPEARING QUITE A BIT / LOST TASTE OF SOME THINGS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient's smell was okay. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amlodipine, atorvastatin, irbesartan, and metoprolol. On 2021, the patient experienced slowly started losing taste / taste disappearing quite a bit / lost taste of some things. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slowly started losing taste / taste disappearing quite a bit / lost taste of some things. This report was non-serious.
Sex: F
Vaccine: UNK
Symptoms: Death
Clinical narrative: Mom passed away 7 months after being injected with that vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Mom passed away 7 months after being injected with that vaccine) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication was not provided. The caller would like to verify the vaccine patient got whether it was experimental or expired. Patient passed away 7 months after being injected with the vaccine. The caller confirmed that her mom was not a part of clinical trial. Treatment information was not reported.   Company Comment: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the serious (due to medically significant and fatal) unexpected event of Death. The event occurred on an unknown date, approximately 7 months after a dose of mRNA-1273 vaccine (date and dose number were not provided). The reporter would like to verify the vaccine patient got whether it was experimental or expired; it was reported that the patient passed away 7 months after being injected with the vaccine. The caller confirmed that her mom was not a part of clinical trial. Reason, date for death, whether an autopsy was performed or not, age, circumstances leading to death, medical history and concomitant medications, were not provided. The outcome of the event was reported fatal. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    The patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 immunization: Moderna Covid-19 vaccine (dose 1 batch:027A21A) on 05-Mar-2021, Moderna Covid-19 vaccine (dose 2 batch:019B21A) on 02-Apr-2021, Moderna Covid-19 vaccine (dose 3 batch:307B21A) on 12-Nov-2021 and Moderna Covid-19 vaccine (dose 4 batch:058A222A) on 28-Jun-2022. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.   On 07-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna COVID-19 vaccine, bivalent on 02-AUG-2023 after a temperature excursion; No adverse event; Vaccine was administered after temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine, bivalent on 02-AUG-2023 after a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch no. AS7644C) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine on 23-Jun-2021; for Product used for unknown indication: Pfizer vaccine on 18-Jan-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine and Pfizer vaccine.    On 02-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) 1 dosage form. On 02-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine, bivalent on 02-AUG-2023 after a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine, bivalent on 02-AUG-2023 after a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine, bivalent on 02-AUG-2023 after a temperature excursion).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  No treatment information was reported.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 immunization: spikevax (dose 1) and spikevax (dose 2); for Drug use for unknown indication: FLU I. Past adverse reactions to the above products included No adverse event with FLU I, spikevax and spikevax. Concurrent medical conditions included Overweight.   In September 2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In May 2023, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. On 05-Dec-2022, COVID-19 (COVID-19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient already received 2 doses of Moderna COVID-19 Vaccine (did not remember dates but he thought it might be 6 months apart. The patient got COVID-19, the patient had mild symptoms, starting with sore throat and decided to get tested, then the patient was treated with Paxlovid and the disease got resolved.
Sex: F
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: She had lifelong chronic eczema and after she got the vaccine her eczema went away and completely gone; She had lifelong chronic eczema and after she got the vaccine her eczema went away and completely gone; 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 female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic eczema" (not ongoing), notes: She had lifelong chronic eczema; "atopic dermatitis" (unspecified if ongoing), notes: she had very bad atopic dermatitis. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "She had lifelong chronic eczema and after she got the vaccine her eczema went away and completely gone".  Additional information: Patient's height was 5'5, a good estimate and weight was probably about 200 pounds, or maybe 180, so, 180 to 200 pounds. Patient got vaccine some time in 2021, noticed eczema improving. Before she got vaccine, was at point where she heard Pfizer made an eczema vaccine, was exploring that because, she had very bad atopic dermatitis. Wanted treatment, to find some solution. After she got vaccine, it started to improve. By 3 months, eczema was completely gone, never came back. Covid vaccine, patient had in 2021 was the Pfizer BioNTech Original Covid vaccine, not the Pfizer Bivalent Covid vaccine, as previously stated.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Lot number: GJ6665), 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 included: "borderline high blood pressure" (unspecified if ongoing); "Allergy to sulfonamide " (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 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: tested positive for COVID on home test; (2023) Negative, notes: initiating Paxlovid I tested negative on an at home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Jun2023 to 07Jun2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300285157 same reporter/patient, different drug/AE;
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Pain
Clinical narrative: Pain; Migraine headache; 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 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: MIGRAINE (non-serious) with onset 2022, outcome "unknown", described as "Migraine headache"; PAIN (non-serious) with onset 2022, outcome "unknown".  Additional Information: Patient had pain and suffering from the past year and a half for the migraine headache. Patient needed to speak to someone who could write a check for pain and suffering for the past year and a half with this migraine headache having.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Gait disturbance, Vertigo
Clinical narrative: vertigo; dizziness; difficulty walking; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 60-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 22Aug2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "Plaque psoriasis" (unspecified if ongoing). The patient took concomitant medication. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 23Aug2023, outcome "unknown", described as "difficulty walking"; DIZZINESS (non-serious) with onset 23Aug2023, outcome "unknown"; VERTIGO (non-serious) with onset 23Aug2023, outcome "unknown". It was unknown if therapeutic measures were taken as a result of vertigo, dizziness, gait disturbance. Additional information: The patient was also taking concomitant medication (unspecified drug) for plaque psoriasis.   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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 at 13:15 as dose 1, single (Lot number: EW0153), in left arm and on 06May2021 at 10:30 as dose 2, single (Lot number: ER8736) at the age of 44 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Nov2021 at 09:30 as dose 3 (booster), single (Lot number: 034F21A), in left arm and on 07Nov2022 at 12:00 as dose 4 (booster), single (Lot number: 014H22A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Nov2021 at 09:30, outcome "unknown", described as "vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19. Clinical course: No Known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300285816 same patient, different drug/event;
Age: 73.0
Sex: M
Vaccine: COVID19, 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). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05May2023 at 10:00 as dose 6 (booster), single (Lot number: GJ3268) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), 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 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 Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 14Aug2023 to 19Aug2023 for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300285705 same patient, different drug/event;
Age: 30.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient 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 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: "History of lymphoma (CHL)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took the Paxlovid treatment from 16Aug2023 to 20Aug2023.  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-202300285829 same patient, different drug/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: PH9992), 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: "Rheumatoid arthritis" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing); "heart attack", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". 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 included Paxlovid.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in right arm and as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "AFib" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "high triglycerides" (unspecified if ongoing); "non-Hodgkins lymphoma/CLL" (unspecified if ongoing); "Known allergies: bees" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine"; Morphine, reaction(s): "Known allergies: morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 17Aug2023 to 22Aug2023. 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: 58.0
Sex: M
Vaccine: COVID19, 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). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2023 at 13:15 as dose 6 (booster), single (Lot number: GJ6743) at the age of 58 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), 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: "Type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 21Aug2023 to 25Aug2023  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: 74.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 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 had no relevant medical history, no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from  18Aug2023 to 23Aug2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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), 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 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with drug Paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 12:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 08Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FP7135), 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: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 15Aug2023 to 19Aug2023.
Age: 54.0
Sex: M
Vaccine: COVID19, 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). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 5 (booster), single (Lot number: Gj5639) at the age of 54 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 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), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
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(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 21Aug2023 to 25Aug2023.  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: 41.0
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(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 41 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: "Hypothyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 17Aug2023 to 21Aug2023.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested Positive on 25Aug2023; Tested Positive on 25Aug2023; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2022 as dose 1, single (Batch/Lot number: unknown) and in May2022 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No known allergies. No covid prior vaccination. No other vaccine in four weeks. No other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Aug2023, outcome "unknown" and all described as "Tested Positive on 25Aug2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical courses:  the patient received all vaccines according to the recommended schedule. No hx (history)/no concomitant meds. Symptoms: Cough and runny nose. No treatment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Developed symptoms of high fever, runny nose, abdominal pain on 24Aug2023/ tested positive for COVID; Developed symptoms of high fever, runny nose, abdominal pain on 24Aug2023/ tested positive for COVID; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the parent.  A 4-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in May2023 as dose 1, single (Batch/Lot number: unknown), in Jun2023 as dose 2, single (Batch/Lot number: unknown) and in Aug2023 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 4 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Treenuts" (unspecified if ongoing). Concomitant medication(s) included: MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE taken for immunisation, on 24Aug2023 as dose number unknown, single. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The patient had no covid prior vaccination. There was no other vaccine in four weeks and no other medications in two weeks. The patient received all the 3 doses of the vaccine within the specified timeframe for her age and all doses administered appropriately. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Aug2023, outcome "not recovered" and all described as "Developed symptoms of high fever, runny nose, abdominal pain on 24Aug2023/ tested positive for COVID". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) high fever, notes: Developed symptoms of high fever; SARS-CoV-2 test: (25Aug2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Tylenol & Motrin for fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy (Vaccination failure and COVID-19) with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received 4 doses (all Pfizer COVID 19 Vaccine)Tested Positive 25Aug2023 no symptoms; Received 4 doses (all Pfizer COVID 19 Vaccine)Tested Positive 25Aug2023 no symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Aug2023, outcome "recovered" (Aug2023) and all described as "Received 4 doses (all Pfizer COVID 19 Vaccine)Tested Positive 25Aug2023 no symptoms". Clinical course: no symptoms. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2023) Positive, notes: Nasal Swab. Therapeutic measures were not 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.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Age: 79.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Lot number: G53277) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EM9809), on 03Mar2021 as dose 2, single (Lot number: EN6203), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: EW0187), in left arm and on 30Mar2022 as dose 4 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation. The patient's relevant medical history included: "repaired mitral valve" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing); "known allergies: iodine in shellfish" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE (Alembic), start date: Jan2013; ATORVASTATIN APOTEX, start date: Jan2018; BAYER ASPIRIN, start date: Jan2013; B1, start date: Jan2018; MACUHEALTH, start date: Jan2021; CALCIUM;MAGNESIUM, start date: Jan1993 (Now Foods); VITAMIN D3, start date: Jan2003 (Now Foods); METHYL B12, start date: Jan2018 (Now Foods); multi vitamin & mineral, start date: Jan1993 (Now Foods). Past drug history included: Levaquin, reaction(s): "known allergies: Levaquin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 17Aug2023 to 22Aug2023.  Clinical course: The patient developed throat congestion, fever, and body aches on 15Aug2023 and tested positive for covid the next day on two Flowflex home covid tests.