chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; 5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date) 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. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-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 30-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date) 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 EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date).    No concomitant medications were reported.  Vial size was 2.5 ml.  Date the vial was initially stored in the refrigerator was 30-Dec-2022.   The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 5th of 5 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-694396 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694396:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vaccine may have been refrozen; No adverse event; 4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing) and PRODUCT STORAGE ERROR (the vaccine may have been refrozen).    No concomitant medication was reported.  The patient received expired original booster Moderna COVID-19 beyond 30 days after thawing and the vaccine may have been refrozen. Pharmacist stated that it was placed in the refrigerator and it was used about 1 week after arriving at the facility.  The vial was initially stored in the refrigerator on 29-Mar-2022, and the vial was administered to patients on 13-Apr-2022, 15-Apr-2022, 22-Apr-2022.  The vial did not undergo temperature excursion. Patient had no adverse events and was not pregnant at the time of vaccination.  No treatment information was provided.  This case contains information for the 2 of 4 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Adult patient received expired original booster Moderna COVID-19 beyond 30 days after thawing; the vaccine may have been refrozen; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received expired original booster Moderna COVID-19 beyond 30 days after thawing) and PRODUCT STORAGE ERROR (the vaccine may have been refrozen).    This case included information of patient 3rd out of 4 specified patients. None of the patient were pregnant.  Concomitant products were not reported.  The vial was initially stored in the refrigerator on 29-Mar-2022, and the vial was administered to patients on 13-Apr-2022, 15-Apr-2022, 22-Apr-2022. The vial did not undergo temperature excursion. The patient received expired original booster Moderna COVID-19 beyond 30 days after thawing and the vaccine may have been refrozen. Patient had no adverse event.  Treatment medications were not reported.   This case was linked to MODERNATX, INC.-MOD-2023-694650 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-694650:Master case
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Administered the second Moderna initial series too early. Instead of doing it at the 1 month or 28 days mark, they gave it at the 19th day mark; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered the second Moderna initial series too early. Instead of doing it at the 1 month or 28 days mark, they gave it at the 19th day mark) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2023,  after starting , the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered the second Moderna initial series too early. Instead of doing it at the 1 month or 28 days mark, they gave it at the 19th day mark). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered the second Moderna initial series too early. Instead of doing it at the 1 month or 28 days mark, they gave it at the 19th day mark) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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 (Administered the second Moderna initial series too early. Instead of doing it at the 1 month or 28 days mark, they gave it at the 19th day mark).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Caller had a nurse that administered the second Moderna initial series too early. Instead of doing it at the 1 month or 28 days mark, they gave it at the 19th day mark. Caller wanted to know if they need to give the patient another dose.  No patient information other than male and vaccine was given on 06-Jan-2023.  No concomitant medication reported. No treatment medication reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Patient received Moderna bivalent vaccine that had undergone a temperature excursion.; Product storage error; Patient received Moderna bivalent vaccine that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.).    No information about patient's previous COVID-19 vaccination doses was available.   Patient received Moderna bivalent vaccine that had undergone a temperature excursion.   The Pharmacist administered the bivalent vaccine before knowing if the vaccine was viable after the temperature excursion. No other adverse reactions were reported. No other information was known about the previous vaccine doses as the patient had not received them at the callers Pharmacy. Pharmacist provided permission for safety to contact her via e-mail.  No concomitant medication reported. No treatment medication reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: After the Bivalent booster on 30DEC2022, he started having pain in the right arm (Injected Arm), and can not the lift arm.; he started having pain in the right arm (Injected Arm),; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (After the Bivalent booster on 30DEC2022, he started having pain in the right arm (Injected Arm), and can not the lift arm.) and VACCINATION SITE PAIN (he started having pain in the right arm (Injected Arm),) in a 67-year-old male patient 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.     Previously administered products included for Drug use for unknown indication: COVID-19 VACCINE JANSSEN (First dose (lot number and expiry date was unknown)); for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Second dose. First Monovalent Moderna COVID-19 Booster dose more than 2 months ago (lot number and expiry date was unknown)). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN and Moderna COVID-19 Vaccine.    On 30-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 30-Dec-2022, the patient experienced VACCINATION SITE PAIN (he started having pain in the right arm (Injected Arm),). On an unknown date, the patient experienced INJECTED LIMB MOBILITY DECREASED (After the Bivalent booster on 30DEC2022, he started having pain in the right arm (Injected Arm), and can not the lift arm.). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of Unknown. At the time of the report, INJECTED LIMB MOBILITY DECREASED (After the Bivalent booster on 30DEC2022, he started having pain in the right arm (Injected Arm), and can not the lift arm.) outcome was unknown and VACCINATION SITE PAIN (he started having pain in the right arm (Injected Arm),) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications details were reported.  Moderna was not authorized to communicate with the vaccine recipient's primary healthcare professional. Patient received 2 Moderna COVID-19 booster vaccine. After the Bivalent booster on 30-Dec-2022, patient started having pain in the right arm (Injected Arm), and can not the lift arm. Patient stated that trying to change gear in the car his right arm hurts. Patient's arm has not improved even with taking Ibuprofen. Patient was on his way to urgent care.   Reporter did not allow further contact
Sex: U
Vaccine: PNC20
Symptoms: Device breakage
Clinical narrative: damaged dose, tip where needle is put on was broken off from vial and was inside of the manufacturer packaging; no patients involved; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 23Dec2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, single (Lot number: GH4081, Expiration Date: Jun2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "damaged dose, tip where needle is put on was broken off from vial and was inside of the manufacturer packaging; no patients involved". Additional information: The reporter provided information on a damaged dose that practice received and was wanting to request a credit for the dose that was damaged if that was possible. The reporter clarified that they were reporting in regards to Prevnar 20 which was damaged upon receiving shipment, the tip where the needle was put on was broken off from the vial and was inside of the package, confirmed inside of the manufacturer packaging. No longer has the damaged product because the reporter was worried about someone getting cut, so the damaged product was put in a sharps container. It was pretty sharp, and nipple was broken off where needle attached to. The reporter confirmed there were no patients involved. The packaging was sealed and intact; confirmed manufacturer packaging was unopened.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 28Jun2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neosporin, reaction(s): "Known allergies: Neosporin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other vaccine in four weeks. Other medication in two weeks was Tylenol. No COVID prior vaccination. COVID tested post vaccination. Patient took PAXLOVID for covid-19 treatment.  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 available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "vaccination failure", "COVID-19".
Age: 68.0
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 contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EL0142), on 21Jan2021 as dose 2, single (Lot number: EL3247), on 05Apr2022 as dose 3 (booster), single (Lot number: FK9896) and on 29Sep2022 as dose 5 (booster), single (Lot number: 301558A) at the age of 68 years for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Lot number: GH9702) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (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 Dec2022, 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 of COVID-19 via Oral route, start date on 23Dec2022, stop date on 28Dec2022. Rhinitis, cough following Paxlovid treatment for COVID-19. This may be rebound. patient was fine, with minor Symptoms, but was encouraged to file this report. Symptoms developed 7 days after completing Paxlovid 5 Day course.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300006844 same patient, different SD/dose and AE;US-PFIZER INC-202300006825 same patient, different SD/dose and AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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: "Insomnia" (unspecified if ongoing), notes: Other 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) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: very first positive test; (Dec2022) Negative, notes: around day 7; (Dec2022) Positive, notes: on day 11; (Dec2022) very positive; (Dec2022) Positive, notes: until 3 weeks. Therapeutic measures were taken as a result of drug ineffective, covid-19. Antiviral details included COVID 19 Treatment i.e., Paxlovid for Treatment of COVID-19 (Treatment start date 12Dec2022 and Treatment stop date 16Dec2022 by oral route. Clinical course: Symptoms (fever, chills, cough, sore throat, fatigue, mm / joint aches) improved after Paxlovid, with negative rapid COVID test x 1 around day 7, then returned on day 11, along with very positive rapid test; symptoms resolved by 2.5 weeks since the infection first started, positive rapid COVID test persisted until 3 weeks since the very first positive test.  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 in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
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 contactable reporter(s) (Other HCP).  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 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: "Behcet's disease" (unspecified if ongoing); "Thrombocytopenia" (unspecified if ongoing); "Dyslipidemia" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "History of thymoma (removed)" (unspecified if ongoing), notes: History of thymoma (removed). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2023) Negative; (05Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 24Dec2022 to 28Dec2022.   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 information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded
Age: 50.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 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. 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: (30Dec2022) negative, notes: I tested negative day 5 of paxlovid treatment and day  8; (02Jan2023) negative, notes: I tested negative day 5 of paxlovid treatment and day  8; (05Jan2023) Positive, notes: Then of day 11 tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 47.0
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 (consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 18:00 as dose 4 (booster), single (batch/lot number: unknown) at the age of 47 years, in right arm for covid-19 immunization; 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 immuniation. The patient's relevant medical history included: "bandage adhesive allergies" (unspecified if ongoing). Concomitant medications included: PROGESTERONE, start date: 01Nov2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: Covid-19 test: positive, notes: treatment of COVID-19; negative, notes: completed the round of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid with treatment start date 28Dec2022 and treatment stop date 02Jan2023. . The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19, 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 (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years, in left 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 included: "high blood pressure" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydrocodone, reaction(s): "known allergies: hydrocodone"; Tapentadol, reaction(s): "known allergies: tapentadol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective and covid-19 with Paxlovid from 04Jan2023 to 05Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna Dose 5: 08Sep2022/Pfizer Dose 4: 15Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2021 at 10:00 as dose 1, single (Lot number: EK9231), in left arm, on 27Jan2021 as dose 2, single (Lot number: EL8982), in left arm, on 31Aug2021 as dose 3 (booster), single (Lot number: FD8448), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Sep2022 as dose 5 (booster), single (Lot number: AS7140C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "h/o atrial fibrillation" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Sep2022, outcome "unknown", described as "Moderna Dose 5: 08Sep2022/Pfizer Dose 4: 15Apr2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
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 75-year-old female patient received BNT162b2 (BNT162B2), in Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing), notes: other medical history: Lymphoma; "IBS" (unspecified if ongoing), notes: other medical history: IBS; "Intestional Blockages" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 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; covid 19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team and product quality group. The reporter is the patient.  A female 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; BNT162b2 (BNT162B2), 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 "covid 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE  & COVID-19  and The suspected drug cannot be ruled out.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 80 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 10Feb2021 as dose 2, single (Lot number: EN9810), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: Other medical history: none at this time. Past cancer patient.; "Known allergies: pecans" (unspecified if ongoing), notes: Known allergies: pecans. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Dyspepsia, Vomiting
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 female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 80 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 10Feb2021 as dose 2, single (Lot number: EN9810), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: Other medical history: none at this time. Past cancer patient.; "Known allergies: pecans" (unspecified if ongoing), notes: Known allergies: pecans. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID symptoms on 04Jan2023 (Wednesday night)/ positive Ag Nasal Swab on 06Jan2023; COVID symptoms on 04Jan2023 (Wednesday night)/ positive Ag Nasal Swab on 06Jan2023; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: CJ6742) at the age of 53 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 was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE], on 28Sep2022 as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2023, outcome "recovering" and all described as "COVID symptoms on 04Jan2023 (Wednesday night)/ positive Ag Nasal Swab on 06Jan2023". COVID symptoms on 04Jan2023 (Wednesday night) and tested Negative; then on 06Jan2023 (also reported as 06Jan2022): positive Ag. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (04Jan2023) Negative, notes: Nasal Swab; (06Jan2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/Woke up with symptoms on Day. Tested positive on 26Dec2022; Treatment of COVID-19/Woke up with symptoms on Day. Tested positive on 26Dec2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 49 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa meds" (unspecified if ongoing); "TIA", start date: Oct2022 (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "migraines" (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 25Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19/Woke up with symptoms on Day. Tested positive on 26Dec2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Positive; (05Jan2023) Positive; (06Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course detials: Woke up with symptoms on Day. Tested positive on 26Dec2022. Started Paxlovid that afternoon. Completed course of medication the morning of 31Dec2022. Started experiencing symptoms again on 05Jan2023. Tested and had a faint positive line on at home test. Tested again at home on 06Jan2023 with full blown symptoms and there was a very bold positive line now showing. No denying it! I'm positive for COVID again. 5-6 days after completing my course of Paxlovid. I did not miss a dose and took them all on schedule.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: EW0186), in left arm and in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. 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 01Jan2023, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient tested positive for COVID after receiving two initial doses and two booster doses of Pfizer COVID Vaccine. Received Pfizer COVID Vaccine to protect from COVID but it did not work.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Incorrect dose administered, Vaccination site pain
Clinical narrative: received the Pfizer COVID-19 Vaccine Gray Cap Bivalent twice within 3 months of each other on 05Oct2022 and 04Jan2023; injection site pain; headache; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Dose: 1st (Booster) Gray cap bivalent), administration date: 05Oct2022, for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 04Jan2023, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 04Jan2023, outcome "unknown", described as "injection site pain"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 04Jan2023, outcome "unknown", described as "received the Pfizer COVID-19 Vaccine Gray Cap Bivalent twice within 3 months of each other on 05Oct2022 and 04Jan2023".  Additional information: Nurse called about a patient who received the Pfizer COVID-19 Vaccine Gray Cap Bivalent twice within 3 months of each other on 05Oct2022 and 04Jan2023. The nurse was looking for further guidance. Called regarding the Pfizer Bivalent booster vaccine for 12+. On the 04Jan2023, had a vaccine clinic at the facility. One of the patients got two Pfizer bivalent boosters within 3 months. One booster vaccine was given 04Jan2023 and the previous booster was given on 05Oct2022. Talked to the patient and notified patient of this. Had talked to the provider as well. Patient reported no severe reactions, just injection site pain and a little headache in the past two days. Had reported the incidence already.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: his wbc T and B cells are elevated/Elevated T cells and B Cells; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: WHITE BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "his wbc T and B cells are elevated/Elevated T cells and B Cells". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that patient received vaccine 6 months ago, and went into the doctor to have some blood work done checking on his T-level thing just general just general guide stuff and he came back and told me that T-cells and my B-cells both in his immune system are elevated, patient asked did the vaccine caused that. One of his HCPs says no and one of his HCPs says yes. Declined transfer to (Redacted) Medical Information as he stated previous agent did not have any information for him at that time. Declined to complete a report at that time. What happened to him just let him know the vaccine was working on the immune system. His HCP has him going to a person to do bloodwork on the 31st to see if he has lymphoma because his T cells and B cells are elevated. It was confirmed that patient's WBC are elevated after getting the Pfizer COVID 19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.