chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RVX
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received Rotavirus vaccine (batch number 35T34) for prophylaxis.   On 21-FEB-2023, the patient received Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number TS425) for prophylaxis.   On 25-JAN-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 17-year-old patient who received Hepatitis A vaccine (batch number LY35X) for prophylaxis.   On 13-JAN-2023, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received Hepatitis A vaccine (batch number LY35X) for prophylaxis.   On 19-JAN-2023, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 10-year-old patient who received Hepatitis A vaccine (batch number CN3G5) for prophylaxis.   On 10-JAN-2023, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received Hepatitis A vaccine (batch number CN3G5) for prophylaxis. On 22-FEB-2023, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown. Additional Information: GSK receipt date: 14-Apr-2023. The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug. Sender's Comments: US-GSK-US2023054677: same reporter; US-GSK-US2023AMR055743: same reporter.
Sex: U
Vaccine: RVX
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received Rotavirus vaccine (batch number CT44F) for prophylaxis.   On 08-FEB-2023, the patient received Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The patient's age was reported as 0 years. The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 18-year-old patient who received Hepatitis B vaccine (batch number DD7K7) for prophylaxis.   On 15-FEB-2023, the patient received Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received Hepatitis A vaccine (batch number LY35X) for prophylaxis.   On 09-JAN-2023, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number TS425) for prophylaxis.   On 27-JAN-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The patient's age was reported as 0 years. The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 17-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA673A) for prophylaxis.   On 17-JAN-2023, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA713A) for prophylaxis.   On 07-FEB-2023, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 12-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA713A) for prophylaxis.   On 21-FEB-2023, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles, reaction on right arm, HZ infection; This non-serious case was reported by a physician via call center representative and described the occurrence of shingles in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-APR-2023, the patient received the 1st dose of Shingrix (left arm). In APR-2023, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles, reaction on right arm, HZ infection). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date:21-APR-2023 The reporter called to report that after Shingrix vaccine a week ago on Monday, doctor experienced active reaction on the right arm which was the opposite where the injection was, similar to an herpes zoster infection.  His dermatologist checked the reaction and said it looked like shingles infection.  No data about lot number or expiration day at the moment of the call. The reporter consented to follow up via email.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Patient got Hiberix after expiration date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old male patient who received Hib (Hiberix) (batch number J7CS5, expiry date 01-APR-2023) for prophylaxis.   In APR-2023, the patient received Hiberix. In APR-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Patient got Hiberix after expiration date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-APR-2023. On 21 April 2023, health care professional reported that a 12 months old male baby received Hiberix vaccine after the expiration date with lot number J7CS5, expiration date 1 April 2023. The approximated administration date of the vaccines was 8 April 2023 but health care professional was not sure about it. The reporter reported that suspect vaccine start date was 2 weeks after expiration date, The reporter consented to follow up. The patient was administered an expired dose of Hiberix, which led to expired vaccine used.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Administered an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 7P2Y3, expiry date 08-APR-2023) for prophylaxis.   On 21-APR-2023, the patient received the 2nd dose of Pediarix. On 21-APR-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Administered an expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-APR-2023 The nurse reported that she administered a dose of Pediarix which had expired. That was the patient's second dose in the series. At the time of reporting, the dose was not been repeated. The Vaccine Administration Facility was the same as Primary Reporter She did not had the facility street address available at time of call. The reporter consented to follow up. The patient was administered with expired vaccine which led to Expired vaccine used.
Sex: F
Vaccine: MENB
Symptoms: Nausea, Vomiting
Clinical narrative: Vomiting; Nausea; This non-serious case was reported by a consumer via sales rep and described the occurrence of vomiting in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, 4 hrs after receiving Bexsero, the patient experienced vomiting (Verbatim: Vomiting) and nausea (Verbatim: Nausea). The outcome of the vomiting and nausea were unknown.   It was unknown if the reporter considered the vomiting and nausea to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the vomiting and nausea to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2023 This report involves reporter's sister's friend's daughter, so very little information was available. The patient received her Bexsero injection (dose unknown) and experienced nausea and vomiting a few hours after the injection and then again experienced nausea and vomiting about one week after the vaccination. The reporter did not consent to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: More energy,feels happy, no longer needs to take Adderall; This non-serious case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Adderall (no longer needs to take her Adderall).  On 07-FEB-2023, the patient received the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: More energy,feels happy, no longer needs to take Adderall). The outcome of the unexpected therapeutic effect was unknown.  Linked case(s) involving the same patient: US2023AMR060467   Additional Information: GSK receipt date:21-APR-2023 The reporter stated that she had the complete Shingrix vaccination series.  With both injections the patient reported she felt happy and had more energy.  She felt happier than she had been in 20 years.  She no longer needs to take her Adderall.  The reporter said the feeling goes away after 31 or 32 days. The reporter consented to follow up. For tolerance to the 2nd dose refer case US2023AMR060467.; Sender's Comments:  US-GSK-US2023AMR060467:Same report/Other dose
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Maladministration of Kinrix after the expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (expiry date 01-APR-2023) for prophylaxis.   On 19-APR-2023, the patient received Kinrix. On 19-APR-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Maladministration of Kinrix after the expiration date). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-APR-2023 No further details such as lot number of the vaccines or patient involved were provided because Nurse was calling from another office. The reporter consented to follow up. The patient received Kinrix which was already expired, which led to expired vaccine used.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other= Moderna; dose 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 28Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Apr2022, outcome "unknown", described as "vaccine brand other= Moderna; dose 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested Covid positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medication in 2 weeks. Covid-19 treated with paxlovid, treatment start date was on 09Apr2023 and Treatment stop date was on 14Apr2023. Patient had no known allergies.  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.
Age: 70.0
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) (Other HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: gh9294) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: ej1685), in left arm, on 05Jan2021 as dose 2, single (Lot number: el3246), in left arm, on 21Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: fk9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing), notes: other medical history: mild asthma; "seasonal allergies" (unspecified if ongoing), notes: other medical history: seasonal allergies; "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. The patient's concomitant medications were not reported. 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: SARS-CoV-2 test: (18Apr2023) Positive; (27Apr2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient had other medication in 2 weeks. Patient received anti viral therapy with brand Paxlovid which was started on 07Apr2023 and stopped on 11Apr2023 for treatment of COVID-19. On 17Apr2023 started with runny nose, which increased over the next 24 hours. COVID home test on 18Apr2023 positive. Cough, malaise, fatigue, diaphoresis and dizziness developed over the next 24 hours. Fatigue, mild SOB, dizziness continue as of 28Apr2023. COVID test negative as of 27Apr2023.  Conclusion of Previously Completed Investigation: The complaint for pfizer-biontech covid-19 vaccine was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot FK9893. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS concluded that the reported defect was not representative of the quality of the batch and the batch remained acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2 and the reported events covid-19, drug ineffective cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Apr2023 to 20Apr2023.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid, start date 16Apr2023 and stop date 21Apr2023.  Clinical course: Patient did not had any known allergies.  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, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9703), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing), notes: other medical history: hyperlipidemia; "osteoporosis" (unspecified if ongoing), notes: other medical history: osteoporosis. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She received other medication in 2 weeks. On 23Apr2023 she received paxlovid (lot number: GG1442) for COVID 19 Treatment which stopped on 24Apr2023. Known allergies included Nothing serious.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Mar2021 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: Covid-19 vaccine (DOSE 1, SINGLE), for covid-19 immunisation. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset Mar2021, outcome "unknown", described as "anaphylaxis".  Clinical Course: A female patient who called into the meeting, indicated they took the PFIZER COVID Vaccine and developed anaphylaxis after the second dose in Mar2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 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: "asthma" (unspecified if ongoing), notes: other medical history: asthma; "heart palpitations" (unspecified if ongoing), notes: other medical history: heart palpitations; "anxiety" (unspecified if ongoing), notes: other medical history: anxiety. Concomitant medication(s) included: WELLBUTRIN, start date: Jan2020, stop date: Apr2023.  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: VERY very positive; slightly positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2 weeks. The patient received anti viral COVID-19 Treatment Paxlovid from 17Apr2023 to 21Apr2023. 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: Hypersomnia, Lethargy, Vaccination site pain
Clinical narrative: lethargic for about 2 or 3 days; arm still hurts from it; it put you to sleep almost for 3 days; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown), in arm 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: LETHARGY (non-serious), outcome "unknown", described as "lethargic for about 2 or 3 days"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "arm still hurts from it"; HYPERSOMNIA (non-serious), outcome "unknown", described as "it put you to sleep almost for 3 days".  Additional information: The patient was 65 years old. The patient stated, "It was of Pfizer vaccine, the first booster (Pfizer COVID-19 Vaccine) caused the patient to get lethargic for about 2 or 3 days and the patient's arms still hurts from it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Obese" (unspecified if ongoing); "Thyroid cancer" (unspecified if ongoing); "Heart arrhythmia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Clinical course: Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 14Apr2023 to 18Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300172194 same reporter/patient, different product/ event.;
Age: 50.0
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. 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 29Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 50 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: "Asthma" (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 21Mar2023, outcome "recovered" (28Mar2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (21Mar2023) Positive; (28Mar2023) Negative. 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: Linked Report(s) : US-PFIZER INC-202300173716 Same patient, different drug, different event;
Sex: M
Vaccine: COVID19-2
Symptoms: Dental implantation
Clinical narrative: he went to the dentist and the dentist would want to do an implant surgery; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Apr2023 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: DENTAL IMPLANTATION (non-serious), outcome "unknown", described as "he went to the dentist and the dentist would want to do an implant surgery". The events "he went to the dentist and the dentist would want to do an implant surgery" required physician office visit.  Additional information: The reporter's husband just took the COVID-19 bivalent Vaccine yesterday and today he went to the dentist and the dentist would wanted to do an implant surgery; she would wanted to know if it was ok for him to have the procedure with the dentist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Vaccination site pain
Clinical narrative: body aches; chills; fatigue; After every vaccines he experienced pain at the injection site for 12 hours; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "After every vaccines he experienced pain at the injection site for 12 hours"; PAIN (non-serious), outcome "unknown", described as "body aches"; CHILLS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown".  Additional information: Patient received multiple Pfizer-BioNTech Covid-19 vaccines as part of the recommended series. After every vaccines he experienced pain at the injection site for 12 hours, chills, body aches, and fatigue.Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: products were not good and needed to be returned with no reported adverse event/ Poor quality vaccine administered with no reported adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who reported that products were not good and needed to be returned with no reported adverse event/ poor quality vaccine administered with no reported adverse event after receiving hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (lot VO7074844) (strength, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination(Immunization).  On an unknown date the patient developed a non-serious event of products were not good and needed to be returned with no reported adverse event/ poor quality vaccine administered with no reported adverse event (product storage error) (unknown latency) following the administration of hib (prp/t) vaccine.  It is unknown if there were lab data/results available.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event products were not good and needed to be returned with no reported adverse event/ poor quality vaccine administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: Poor quality vaccine administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2023SA129826.  This case involves Infant and unknown gender patient who had poor quality vaccine administered with no reported adverse event after receiving vaccine hib (prp/t) vaccine [act-hib].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (unknown strength), lot UJ756AAA, expiration date- 12-aug-2023  via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious poor quality vaccine administered with no reported adverse event (poor quality product administered) (unknown latency).  It was unknown if there were lab data/results available.  Action taken was not applicable.  Outcome: Unknown for the event poor quality vaccine administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA124713:
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: products were not good and needed to be returned with no reported adverse event; poor quality vaccine administered/excursion vaccine was administered with no reported adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves Infant and unknown gender patient who involved in the products HIB (PRP/T) VACCINE [ACT-HIB] were not good and needed to be returned and poor quality vaccine administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 ml dose of suspect products HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot number: UJ756AAA, expiry date: 12-Aug-2023, strength, route administrative site: Unknown) for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious events of  "products were not good and needed to be returned with no reported adverse event (product storage error) and poor quality vaccine administered with no reported adverse event (poor quality product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for both the event products.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: cold chain break is reported with no reported adverse event; Poor quality vaccine administered/excursion vaccine was administered with no reported adverse event ,; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA124713 and 2023SA129811.  This case involves Infant and unknown gender patient for whom poor quality vaccine HIB (PRP/T) vaccine [ACT-HIB] administered of which cold chain break with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date the cold chain break is reported with no reported adverse event (product storage error) and patient received a dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection with unknown strength, dose, batch number, expiry date via unknown route in unknown administration site for prophylactic vaccination was administered with no reported adverse event (poor quality product administered) (latency: same day).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.