chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; received expired doses of the Moderna COVID19 vaccine bivalent from the same vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Jul-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 31-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial) 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 (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial).    No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided. This case contains information for the 1st patient out of 2 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-735212 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735212:Patient 2
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (First vaccine) on 30-Dec-2020. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE.    In October 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. In December 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient caught Covid-19 in December of 2022. It lasted for 10 days. Patient had a runny nose and a cough for several days and felt like a virulent strain. No treatment medication was reported.
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Malaise, Nasopharyngitis, Pain
Clinical narrative: achey; cold-like symptoms; worn out; unwell; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NASOPHARYNGITIS (cold-like symptoms), FATIGUE (worn out), MALAISE (unwell) and PAIN (achey) in an 86-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was reported that patient was otherwise healthy.     On 31-Jul-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Aug-2023, the patient experienced NASOPHARYNGITIS (cold-like symptoms), FATIGUE (worn out) and MALAISE (unwell). On an unknown date, the patient experienced PAIN (achey). At the time of the report, NASOPHARYNGITIS (cold-like symptoms), FATIGUE (worn out) and MALAISE (unwell) had not resolved and PAIN (achey) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that advised reporter to refer to mother's health care professional for treatment options.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Initially stored in the refrigerator on 21-Jun-2023 and administered on 25-Jul-2023; No adverse event; Vaccines past the expiration date and administered them to 3 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients), PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 25-Jul-2023) 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. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Jul-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 25-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 25-Jul-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients), PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 25-Jul-2023) 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 EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients) and PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 25-Jul-2023).    Concomitant medication was not reported. Date the vial was initially stored in the refrigerator on 21-Jun-2023. Use by date of vial was 21-Jul-2023. The dose was administered after 30-day Use By Date. Vial did not undergo any temperature excursions. Treatment medication was not reported.  This case was for the 2nd patient out of 3 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735312 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2023: Non-significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735312:Master case/Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Initially stored in the refrigerator on 21-Jun-2023 and administered on 28-Jul-2023; No adverse event; Vaccines past the expiration date and administered them to 3 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients), PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 28-Jul-2023) 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. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-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 28-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 28-Jul-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients), PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 28-Jul-2023) 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 EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients) and PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 28-Jul-2023).    Concomitant medication was not reported. Date the vial was initially stored in the refrigerator on 21-Jun-2023. Use by date of vial was 21-Jul-2023. The dose was administered after 30-day Use By Date. Vial did not undergo any temperature excursions. Treatment medication was not reported.  This case was for the 3rd patient out of 3 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735312 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2023: Non-significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735312:Master case/Patient 1
Age: 1.83
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient who received an incorrect product for their 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient who received an incorrect product for their 2nd dose) and NO ADVERSE EVENT (No adverse event) in a 22-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     Patient had no relevant medical history or previous COVID-19 diagnosis and did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Lot AS1417B) on 03-Jan-2023. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 19-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 19-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient who received an incorrect product for their 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient who received an incorrect product for their 2nd 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 WRONG PRODUCT ADMINISTERED (Patient who received an incorrect product for their 2nd dose).    No concomitant medication was reported.  It was reported that HCP was unsure of the exact dosage but stated that since the pink cap vial dosing was indicated as 0.2 mL, that must be the dosage the patient would have received for their 2nd dose. Patient had not reported any adverse reactions from either dose. No treatment medication was reported.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Brain death, Headache, Influenza, Influenza B virus test positive, Lethargy
Clinical narrative: brain dead; strep pneumonia; headache; lethargic; positive for flu B; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 3-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 23Apr2021 as dose 4, single (Batch/Lot number: unknown) at the age of 12 months for immunisation. The patient's relevant medical history included: "Flu B" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Prevnar 13 (first dose), for Immunisation; Prevnar 13 (second dose), for Immunisation; Prevnar 13 (third dose), for Immunisation. The following information was reported: BRAIN DEATH (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 22Jul2023, outcome "not recovered", described as "brain dead"; HEADACHE (caused and prolonged hospitalization, disability, life threatening) with onset 22Jul2023, outcome "not recovered"; LETHARGY (caused and prolonged hospitalization, disability, life threatening) with onset 22Jul2023, outcome "not recovered", described as "lethargic"; INFLUENZA (caused and prolonged hospitalization, disability, life threatening) with onset 22Jul2023, outcome "not recovered", described as "positive for flu B"; PNEUMONIA STREPTOCOCCAL (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 22Jul2023, outcome "not recovered", described as "strep pneumonia". The patient was hospitalized (hospitalization duration: 10 days). The patient underwent the following laboratory tests and procedures: Influenza B virus test: (22Jul2023) positive. Therapeutic measures were taken as a result of brain death, pneumonia streptococcal, headache, lethargy, influenza. The physician did not believe the patient will live. The physician also stated that the Serotype that caused the pneumonia was not covered in Prevnar 13, but the physician didn't know the serotype of Streptococcus pneumonia that he was infected with.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: All events are considered unrelated to the use of PREVNAR 13;  pneumonia not covered by PCV 13 represents an intercurrent bacterial infection.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia streptococcal
Clinical narrative: brain dead; strep pneumonia; headache; lethargic; positive for flu B; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 3-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 23Apr2021 as dose 4, single (Batch/Lot number: unknown) at the age of 12 months for immunisation. The patient's relevant medical history included: "Flu B" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Prevnar 13 (first dose), for Immunisation; Prevnar 13 (second dose), for Immunisation; Prevnar 13 (third dose), for Immunisation. The following information was reported: BRAIN DEATH (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 22Jul2023, outcome "not recovered", described as "brain dead"; HEADACHE (caused and prolonged hospitalization, disability, life threatening) with onset 22Jul2023, outcome "not recovered"; LETHARGY (caused and prolonged hospitalization, disability, life threatening) with onset 22Jul2023, outcome "not recovered", described as "lethargic"; INFLUENZA (caused and prolonged hospitalization, disability, life threatening) with onset 22Jul2023, outcome "not recovered", described as "positive for flu B"; PNEUMONIA STREPTOCOCCAL (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 22Jul2023, outcome "not recovered", described as "strep pneumonia". The patient was hospitalized (hospitalization duration: 10 days). The patient underwent the following laboratory tests and procedures: Influenza B virus test: (22Jul2023) positive. Therapeutic measures were taken as a result of brain death, pneumonia streptococcal, headache, lethargy, influenza. The physician did not believe the patient will live. The physician also stated that the Serotype that caused the pneumonia was not covered in Prevnar 13, but the physician didn't know the serotype of Streptococcus pneumonia that he was infected with.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: All events are considered unrelated to the use of PREVNAR 13;  pneumonia not covered by PCV 13 represents an intercurrent bacterial infection.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache and shooting pain in her left forehead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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, SINGLE), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), 1 week after the suspect product(s) administration, outcome "unknown", described as "headache and shooting pain in her left forehead".  Additional information: The agent provides that the patient is reporting that after having the Pfizer Biontech COVID-19 vaccine she is experiencing headache and shooting pain in her left forehead. The caller refers it feels almost like a lightning bolt and it is getting its getting more frequent. She started experiencing this headache one week after getting the second dose of the Pfizer Biontech COVID-19 vaccine. "It does not happen every day, its sporadically and randomly. Caller also states that seven people she has talked to have referred getting headache since they got their shots. The caller wants to know if there are reports of headache. The caller asked if these headaches can lead to stroke or brain aneurisms, are there reports of strokes or brain aneurisms as side effect of the vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300266912 same , different patient.;US-PFIZER INC-202300266906 same SD/AE, different patient.;US-PFIZER INC-202300266915 same SD/AE, different patient.;US-PFIZER INC-202300266914 same SD/AE, different patient.;US-PFIZER INC-202300266911 same SD/AE, different patient;US-PFIZER INC-202300266913 same SD/AE, different patient;US-PFIZER INC-202300266910 same SD/AE, different patient.;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 17Aug2021 as dose 1, single (Lot number: FC3182), in left arm, on 07Sep2021 as dose 2, single (Lot number: FC3184), in left arm and on 01Apr2022 as dose 3 (booster), single (Lot number: FK9893) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "severe COPD", start date: 2008 (ongoing); "Prediabetes" (ongoing); "Borderline hypertension, fluid, and blood pressure" (ongoing); "Borderline hypertension, fluid, and blood pressure" (ongoing). Concomitant medication(s) included: GLUCOCIL taken for glucose tolerance impaired (ongoing); HYDROCHLOROTHIAZIDE oral taken for hypertension, blood pressure abnormal (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". The event "covid 19 treatment" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid (30Jul2023 to 01Aug2023). Clinical course: She had covid once before and had 3 of the vaccinations. She went to the ER (Emergency Room) on Saturday and they said she had covid and gave her a prescription for Paxlovid. She had 2 shots and got covid. She had a booster in Apr2022. Had covid the first time in 2021. She was 56 years old the first time she had covid and had covid again at 58 years old. She had cancer in her family.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300266686 Same patient, different drug, different event;
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: seven people she has talked to have referred getting headache since they got their shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: HEADACHE (non-serious), outcome "unknown", described as "seven people she has talked to have referred getting headache since they got their shots".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300266655 same SD/AE, different patient.;
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: seven people she has talked to have referred getting headache since they got their shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: HEADACHE (non-serious), outcome "unknown", described as "seven people she has talked to have referred getting headache since they got their shots".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300266655 same SD/AE, different patient;
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction positive, 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 09Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 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: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: two days in a row of negative antigen test; (unspecified date) Negative, notes: two days in a row of negative antigen test; (26Jul2023) Positive; (27Jul2023) Positive, notes: positive antigen tests on Day 1, 2, 3, & 4; (28Jul2023) Positive, notes: positive antigen tests on Day 1, 2, 3, & 4; (29Jul2023) Positive, notes: positive antigen tests on Day 1, 2, 3, & 4; (30Jul2023) Positive, notes: positive antigen tests on Day 1, 2, 3, & 4; (31Jul2023) Positive; (01Aug2023) Negative; (02Aug2023) Positive; Polymerase chain reaction positive: (26Jul2023) 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 17Aug2021 as dose 1, single (Lot number: FC3182), in left arm and on 07Sep2021 as dose 2, single (Lot number: FC3184) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD", start date: 2008 (ongoing); "Borderline hypertension" (unspecified if ongoing); "Fluid" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing). Concomitant medication(s) included: GLUCOCIL taken for glucose tolerance impaired (ongoing); HYDROCHLOROTHIAZIDE oral taken for hypertension, fluid imbalance, blood pressure measurement (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "COVID 19".
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cystic fibrosis" (unspecified if ongoing). Concomitant medication(s) included: ZENPEP, start date: 01Oct2016, stop date: 02Aug2023; TRIKAFTA. 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 event "treatment of covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: testing positive for Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After testing positive for Covid-19 for the first time since the pandemic began, the patient reached out to his doctor on 18Jul2023 for guidance on treatment options and he recommended a 5 day course of Paxlovid. The patient had other medication in 2 weeks. The patient was also taking 14 medications routinely. His Trikafta prescription was modified while taking the Paxlovid based on his doctor's instructions. The patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: have been sick eversince getting vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 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: MALAISE (non-serious), outcome "unknown", described as "have been sick eversince getting vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
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 non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, 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 Jul2023, outcome "recovered" (31Jul2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Positive; (31Jul2023) Negative; (Aug2023) positive, notes: positive Covid test again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID 19 treatment included Paxlovid from 24Jul2023 to 29Jul2023. Other medication included Tylenol from 24Jul2023 to 27Jul2023. The patient had rebound of Covid symptoms on 03Aug2023 at 05:00 AM and positive Covid test again after negative test on 31Jul2023. This further event was recovering with no treatment.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen glands in my neck 9 days after the vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Jul2023 at 08:45 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 03Aug2023 at 14:00, outcome "recovering", described as "Swollen glands in my neck 9 days after the vaccination". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient had no other vaccine in four weeks and no other medications in 2 weeks. The patient had swollen glands in my neck 9 days after the vaccination. It was reported that the patient had no covid prior vaccination and was not covid tested post vaccination. The patient had no known allergies.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Large welt/hive, completely round; Itching; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Jul2023 as dose 6 (booster), single (Lot number: GM1767) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergy to Iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction: "known allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot number: unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot number: unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot number: unknown), for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 31Jul2023, outcome "recovering", described as "Itching"; URTICARIA (non-serious) with onset 31Jul2023, outcome "recovering", described as "Large welt/hive, completely round". Therapeutic measures were not taken as a result of urticaria, pruritus. Additional information: Welt was still present after 48 hours. The vaccination facility type was a pharmacy or drug store. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination and was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6206), in right arm, on 25Mar2021 as dose 2, single (Lot number: EP7533), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Double pneumonia from a respiratory virus" (unspecified if ongoing), notes: 7 years ago. There were no concomitant medications. 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: (2023) Negative, notes: after 5 days; (2023) Positive, notes: again on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: No known allergies. Patient received anti-viral treatment for Covid 19 with Paxlovod from 24Jul2023 to 29Jul2023.
Sex: U
Vaccine: TTOX
Symptoms: Hypotension
Clinical narrative: hypotension; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from an other health professional. This was a courtesy case received from Pfizer.  This case involves an unknown age and unknown gender patient who experienced hypotension after receiving vaccine Tetanus toxoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included palbociclib (Ibrance) for Malignant breast neoplasm and Bone neoplasm malignant.  On an unknown date, the patient received a dose of suspect tetanus toxoid produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength, lot/batch number and expiration date: not provided) for Immunisation.  On an unknown date the patient developed hypotension (unknown latency) following the administration of tetanus toxoid.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel was accidentally administered to a patient (with no adverse event); Initial information received on 31-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient and expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] was accidentally administered to patient (with no adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) for Prophylactic vaccination.  On an unknown date, the patient received 0.5 ml of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength unknown) (lot number: C5893AA, Expiry date: 21-Jun-2023) via intramuscular route in the left thigh for immunization.  On an unknown date, expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine was accidentally administered to patient (with no adverse event) (expired product administered) (latency: same day).  It was reported, Caller reported that an expired DAPTACEL was accidentally administered to a patient and wants to know if they need to re-dose.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: RAB
Symptoms: Medication error, No adverse event, Product dose omission in error
Clinical narrative: patient did not come into the pharmacy and missed second dose of Imovax rabies on Friday 28Jul2023 because they thought that the pharmacy was closed for power outages with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who come into the pharmacy and missed second dose of imovax rabies on friday 28jul2023 because they thought that the pharmacy was closed for power outages with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Jul-2023, suspect Rabies (HDC) Vaccine, Powder and solvent for suspension for injection via unknown route in unknown administration site for Immunization/pre-exposure prophylaxis (strength, dose, batch number and expiry dat: unknown), patient did not come into the pharmacy and missed second dose of imovax rabies on friday 28jul2023 because they thought that the pharmacy was closed for power outages with no reported adverse event (Product dose omission in error) (latency same day).  Information on the batch number was requested  Action taken: not applicable.  Outcome was Unknown for the event product dose omission issue  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Fridge door opened for long Max/Low temperature reached: 46.6F Duration-2 minutes with no adverse event; ipol given after the temperature excursion with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235015, 2023SA235023, 2023SA235246, 2023SA235694, 2023SA236046 and 2023SA234814.  This case involves a 6 years old male patient to whom ipol given after the temperature excursion with no reported adverse and fridge door opened for long max/low temperature reached: 46.6f duration-2 minutes with no adverse event and event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine), hepatitis A vaccine (Hepatitis A) and COVID-19 vaccine for Prophylactic vaccination.  On 27-Jul-2023, the patient received 0.5 ml (dose 6) of suspect IPV (VERO), Suspension for injection lot W1A191M, expiry date: 16-Feb-2025 via subcutaneous route in the left thigh for immunization (strength: unknown), given after the temperature excursion with no reported adverse event (poor quality product administered) (latency same day).  On an unknown date the fridge door opened for long max/low temperature reached: 46.6f duration-2 minutes with no adverse event (product storage error) (unknown latency).  This situation is due to human error.  Action taken: not applicable  Outcome was Unknown for the events poor quality product administered and product storage error  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: punctured ipol temperature reached: 46.6 F duration was 2 minutes with no reported adverse event; patient was given IPOL after the temperature excursion with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235015, 2023SA235023, 2023SA235246, 2023SA235694, 2023SA235058 and 2023SA234814.  This case involves a 11 years old male patient who was given ipol after the temperature excursion and punctured ipol temperature reached: 46.6 f duration was 2 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 13-Jul-2023, 0.5 ml (dose 3) of suspect IPV (VERO), Suspension for injection lot W1A191M, expiry date: 15-Feb-2025 via intramuscular route in the right arm for Immunization (strength: unknown), patient was given ipol after the temperature excursion with no reported adverse event (poor quality product administered) (latency same day).  On an unknown date punctured ipol temperature reached: 46.6 f duration was 2 minutes with no reported adverse event (product storage error) (unknown latency).  This situation is due to human error.  Action taken: not applicable.  Outcome was Unknown for the events poor quality product administered and product storage error.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: opened ipol exposed to 46.6f upto 2 minutes with no reported adverse event; opened ipol exposed to 46.6f upto 2 minutes was administered to patients with no reported adverse event; Initial information received on 31-Jul-2023  regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA235015, 2023SA235023, 2023SA235246, 2023SA236046, 2023SA235058 and 2023SA235694.  This case involves a 15 years old female patient who was administered opened IPV (VERO) [IPOL] post exposure to 46.6f upto 2 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Jun-2023, the patient received 0.5 mL dose 4 of suspect IPV (VERO), suspension for injection (batch number: W1A191M; expiry date: 16-Feb-2025) via subcutaneous route in the left arm for Immunization post exposure to 46.6f upto 2 minutes with no reported adverse event (poor quality product administered) (same day latency) (product storage error) (unknown latency).  Reportedly, Reason for excursion was Fridge door opened for long; Max/Low temperature reached was 46.6F; Duration of temperature excursion was 2 minutes; human error: Yes  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events poor quality product administered and product storage error.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.