chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Two patients came in to get bivalent booster. The fill-in pharmacist gave them the monovalent instead.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Two patients came in to get bivalent booster. The fill-in pharmacist gave them the monovalent instead.) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Two patients came in to get bivalent booster. The fill-in pharmacist gave them the monovalent instead.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Two patients came in to get bivalent booster. The fill-in pharmacist gave them the monovalent instead.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Two patients came in to get bivalent booster. The fill-in pharmacist gave them the monovalent instead.).    No concomitant medications were reported.  Reporter stated that would like to know the protocol for a patient receiving a monvalent(red top) vaccine, but they should have been given the bivalent(blue top) vaccine.  The pharmacist states he reported to VAERS, but he does not had the VAERS report number.  No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: a little bit of an issue, we should be able to look up to see if it's a monovalent or bivalent/ This will help us to determine whether a patient is due for further vaccination or not; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (a little bit of an issue, we should be able to look up to see if it's a monovalent or bivalent/ This will help us to determine whether a patient is due for further vaccination or not) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (a little bit of an issue, we should be able to look up to see if it's a monovalent or bivalent/ This will help us to determine whether a patient is due for further vaccination or not) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (a little bit of an issue, we should be able to look up to see if it's a monovalent or bivalent/ This will help us to determine whether a patient is due for further vaccination or not) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (a little bit of an issue, we should be able to look up to see if it's a monovalent or bivalent/ This will help us to determine whether a patient is due for further vaccination or not).    No concomitant medications details were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. HCP was calling from a hospital who wanted to confirm whether a lot number was bivalent or monovalent. Caller declined providing contact info and stated she was on a hurry. It was reported that, it was assume to be bivalent vaccine.   No treatment medications details were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental overdose, No adverse event
Clinical narrative: An HCP is reporting that a patient got the Moderna COVID-19 Vaccine, Bivalent booster but received an entire vial instead of one dose.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (An HCP is reporting that a patient got the Moderna COVID-19 Vaccine, Bivalent booster but received an entire vial instead of one dose.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (An HCP is reporting that a patient got the Moderna COVID-19 Vaccine, Bivalent booster but received an entire vial instead of one dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (An HCP is reporting that a patient got the Moderna COVID-19 Vaccine, Bivalent booster but received an entire vial instead of one dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (An HCP is reporting that a patient got the Moderna COVID-19 Vaccine, Bivalent booster but received an entire vial instead of one dose.).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   No concomitant medications were reported.  No treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 02Feb2021 First dose10Mar2021 Second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02Feb2021 First dose10Mar2021 Second dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02Feb2021 First dose10Mar2021 Second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02Feb2021 First dose10Mar2021 Second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02Feb2021 First dose10Mar2021 Second dose).    No concomitant medications were reported. It was reported that age of caller was not confirmed. No treatment medications were reported.
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Neck pain, Vaccination site lymphadenopathy
Clinical narrative: swollen lymph nodes; soreness up and down her neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes) and NECK PAIN (soreness up and down her neck) in a 23-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINES on 22-Dec-2022 and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINES and PFIZER BIONTECH COVID-19 VACCINE.    On 22-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Dec-2022, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes) and NECK PAIN (soreness up and down her neck). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes) and NECK PAIN (soreness up and down her neck) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2023, Blood test: (Positive) doctor said she tested positive for mono.     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 were reported.  Patient received vaccination of Pfizer 1st dose in April 2021, Pfizer 2nd dose in May 2021, Pfizer booster in December 2021. The patient reports she had bad swollen lymph nodes. She had soreness up and down her neck. It started 24 hours after the shot. It stuck around for a while, so patient got blood work. On 1Feb2023 she was tested positive for mono. She still having soreness and swollen lymph nodes now.   No treatment medication were reported.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash pruritic, Urticaria
Clinical narrative: itching, rash, hives all over his body; itching, rash, hives all over his body; This spontaneous case was reported by a physician and describes the occurrence of RASH PRURITIC (itching, rash, hives all over his body) and URTICARIA (itching, rash, hives all over his body) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Allergy: penicillin.  Concurrent medical conditions included Penicillin allergy.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itching, rash, hives all over his body) and URTICARIA (itching, rash, hives all over his body). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency and RUXOLITINIB PHOSPHATE (OPZELURA) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itching, rash, hives all over his body) and URTICARIA (itching, rash, hives all over his body) 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.   Concomitant product use was not provided by the reporter. The physician reported itching, rash, hives all over his body. He did not connect the symptoms to the booster shot until he read an article. It had been at least since holiday. The physician reported using triamcinolone (topical steroid) cream and opzelura cream. He needed a solution. He had been to a dermatologist and allergist, but they could not figure it out.
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: itching; hives; rashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jan2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; fluconazole (FLUCONAZOLE), since Jan2023 at unk (for 2 weeks). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching"; URTICARIA (non-serious), outcome "unknown", described as "hives"; RASH (non-serious), outcome "unknown", described as "rashes". The action taken for fluconazole was unknown.  Additional information: Patient was given a prescription last week from the time of reporting (Jan2023) for fluconazole 100mg tablet to take for two weeks. Patient broke out in itching hives rashes. She never had a reaction to it before. Two weeks prior to taking it, she had Prevnar 20. Patient is asking if Prevnar 20 cause her reaction to the Fluconazole.  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.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: My cousin has Myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "My cousin has Myocarditis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 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 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin"; Dilaudid, reaction(s): "Known allergies: Dilaudid"; Doxycycline, reaction(s): "Known allergies: Doxycycline". 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.  Clinical course: The patient took other medication in two weeks. The patient took Antiviral drug Paxlovid from 25Jan2023 to 30Jan2023 for the treatment of COVID-19.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 57.0
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) (Physician). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral Paxlovid from 20Jan2023 to 25Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events  DRUG INEFFECTIVE, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (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), 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: "fibromyalgia" (unspecified if ongoing); "SLE" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "thalassemia" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: depakote for Known allergies: depakote; Known allergies: trazodone for Known allergies: trazodone. 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.  Clinical information: Patient received Paxlovid for COVID 19 Treatment start date was 21Jan2023 and stop date was 25Jan2023. Patient had known allergies of Depakote and trazodone.  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 currently available, The casual association between the reported events and suspected drug cannot be completely excluded.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2 NOS), on 01Nov2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive again starting four days after last Dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks, No Known allergies, Other medical history were none. The patient received Paxlovid Treatment start date: 17Jan2023, stop date: 21Jan2023.  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). The reporter is the patient.  A 63-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 included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Other medical history: Diabetes" (unspecified if ongoing), notes: Other medical history: Diabetes. 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, notes: began testing positive; Negative, notes: I tested negative for 10 days after completing the Paxlovid 5-day dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 15Jan2023 the patient took Paxlovid for the treatment of event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Adult (18-64 Years). Other medication in 2weeks was reported as no.Patient was received Paxlovid as treatment. Treatment start date 31Jan2023. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 12Oct2021 as dose 3 (booster), single (Lot number: EW0186), in left arm and on 27Apr2022 as dose 4 (booster), single (Lot number: FJ8762), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19 virus  test: Positive, notes: Tested positive after Paxlovid treatment and testing negative; Negative, notes: Tested positive after Paxlovid treatment and testing negative; Positive, notes: Now testing positive again. Therapeutic measures were taken as a result of vaccination failure, COVID-19 with Paxlovid from 18Jan2023 to 23Jan2023.
Age: 33.0
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). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive, notes: positive test two days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Recurrence of Covid symptoms and positive test two days after negative test. No other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 03Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: My cousin now has Myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "My cousin now has Myocarditis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 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 had no relevant medical history. There were no concomitant medications. 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.  Clinical course: Patient received Paxlovid (Lot number: 3006903455307) for COVID 19 treatment from 22Jan2023 to 26Jan2023. Patient had no known allergies. Patient did not receive other medication in 2 weeks.  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: 70.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was received Paxlovid as treatment. Treatment start date: 22Jan2023, Treatment stop date: 27Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
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) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Heart Disease" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: walnuts" (unspecified if ongoing). Concomitant medication(s) included: RABEPRAZOLE SODIUM; LOSARTAN POTASSIUM. 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 and treated with Paxlovid from 20Jan2023 to 24Jan2023.
Sex: F
Vaccine: COVID19
Symptoms: Lichenoid keratosis
Clinical narrative: extremely itchy lichenoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000000067.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization, reaction(s): "extremely itchy lichenoid rash". The following information was reported: LICHENOID KERATOSIS (non-serious), outcome "unknown", described as "extremely itchy lichenoid".  Additional information: On 12Jan2023, it was reported that a patient was vaccinated on an unspecified date in Jun2022 with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1, dose 2, dose 3 (booster dose) and dose 4 (bivalent booster) for Covid-19 immunization. Reportedly, the individual experienced an extremely itchy lichenoid rash after taking the original two-dose Pfizer COVID vaccine. The rash improved with time but got worse after the first Pfizer booster, improved again, and got worse after the bivalent Pfizer booster.  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: Condition aggravated, Lichenoid keratosis
Clinical narrative: extremely itchy lichenoid; got worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000000067 (RA).  A female patient received BNT162b2 (BNT162B2), 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "extremely itchy lichenoid"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "extremely itchy lichenoid". The following information was reported: LICHENOID KERATOSIS (medically significant), outcome "recovering", described as "extremely itchy lichenoid"; CONDITION AGGRAVATED (medically significant), outcome "recovering", described as "got worse".  Clinical course: On 12Jan2023, it was reported that a patient was vaccinated on an unspecified date in Jun2022 with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1, dose 2, dose 3 (booster dose) and dose 4 (bivalent booster) for Covid-19 immunisation. Reportedly, the individual experienced an extremely itchy lichenoid rash after taking the original two-dose Pfizer COVID vaccine. The rash improved with time but got worse after the first Pfizer booster, improved again, and got worse after the bivalent Pfizer booster.  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: Balance disorder, Cerebrovascular accident, Facial pain, Hemiplegia, Thrombosis
Clinical narrative: Almost completely over stroke; Affecting left side; Blood clot in lower left leg; After shots balance worsened; Pressure on left side of face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Almost completely over stroke"; HEMIPLEGIA (medically significant), outcome "unknown", described as "Affecting left side"; THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot in lower left leg"; BALANCE DISORDER (non-serious), outcome "unknown", described as "After shots balance worsened"; FACIAL PAIN (non-serious), outcome "unknown", described as "Pressure on left side of face". The events "almost completely over stroke", "affecting left side", "blood clot in lower left leg", "after shots balance worsened" and "pressure on left side of face" required emergency room visit.  Clinical course: Had reaction to shots (2 + 1 booster). Almost completely over stroke 10Dec2 (as reported), affecting left side, & after shots balance worsened (98% later 80%) & at the time of report need a cane, blood clot in lower left leg & pressure on left side of face. All of these things occurring after shots. Patient was mystified whether to go lawyer or clinic. ER many times from COVID shots.  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-202300049900 Same patient/event, same drug in different dose;US-PFIZER INC-PV202300018058 Same patient/event, same drug in different dose;
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EP7534) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: BELL'S PALSY (hospitalization, disability, medically significant) with onset Mar2021, outcome "unknown", described as "Bells Palsy". The event "bells palsy" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of bell's palsy.  Clinical course: No other vaccine in four weeks. Bells Palsy - 12 hours post vaccination Required 2 stents due to "new heart issues" 23Jul2021 Required 1 stent due to "new heart issues" 03Sep2021 Death classified as Arteriosclerotic Cardiovascular Disease.
Age: 58.0
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) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2021 as dose number unknown, single (Lot number: EW0167), in left arm and on 08Dec2021 as dose number unknown, single (Lot number: FD7218) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (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 Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 28Jan2023 the patient took Paxlovid for the treatment of event. The patient had no known allergy.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 11:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 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. Past drug history included: Diflurcan, reaction(s): "known allergies: Diflurcan", notes: known allergies: Diflurcan; Ultram, reaction(s): "known allergies: Ultram", notes: known allergies: Ultram. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Negative; (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had received Paxlovid for covid 19 treatment from 18Jan2023 to 23Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: 30135BA), 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: "Acute Pancreatitis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine, Mild. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound, about 1 week after testing Negative twice. Mild case; Negative, notes: Rebound, about 1 week after testing Negative twice. Mild case. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in May2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eryhtromelalgia" (unspecified if ongoing); "Fibromuscular dysplagia" (unspecified if ongoing); "Gluten allergy" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: Apr2022; AMITRIPTYLINE, start date: Jan2020; MULTIVITAMINS [VITAMINS NOS], start date: 01May2019. Past drug history included: Clindamyasin, reaction(s): "Allergy"; Vicodin, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2022, outcome "unknown"; COVID-19 (medically significant) with onset Jan2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset Jan2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300051016 Same patient/product and different dose/events;
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Recent emergency appendectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "known allergies: Neomycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive; (01Feb2023) Faint positive, notes: with mild symptoms; (02Feb2023) Strong positive, notes: with full symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 24Jan2023 to 28Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2, BNT162B2 OMI BA.4-5 cannot be excluded. The case will be reassessed once new information is available.