chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (unknown if pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11May2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Pitted fruits" (unspecified if ongoing); "Known allergies: some statin drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 31Aug2023 to 04Sep2023.  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, COVID19, COVID19
Symptoms: Chronic lymphocytic leukaemia, Diffuse large B-cell lymphoma
Clinical narrative: CLL; DLBCL; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 6 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant), outcome "unknown", described as "CLL"; DIFFUSE LARGE B-CELL LYMPHOMA (medically significant), outcome "unknown", described as "DLBCL". Therapeutic measures were taken as a result of chronic lymphocytic leukaemia, diffuse large b-cell lymphoma. Additional information: The patient reported having Chronic lymphocytic leukaemia (CLL) and Diffuse large B-cell lymphoma (DLBCL). He/She completed 6 cycles of R-CHOP in Nov2022 and 18 radiation treatments in Jan2023. He/she had a complete response DLBCL and the CLL is not active but will return.   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-PV202300154339 same patient and drug, different vaccine dose/event;
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: CLL; DLBCL; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 6 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant), outcome "unknown", described as "CLL"; DIFFUSE LARGE B-CELL LYMPHOMA (medically significant), outcome "unknown", described as "DLBCL". Therapeutic measures were taken as a result of chronic lymphocytic leukaemia, diffuse large b-cell lymphoma. Additional information: The patient reported having Chronic lymphocytic leukaemia (CLL) and Diffuse large B-cell lymphoma (DLBCL). He/She completed 6 cycles of R-CHOP in Nov2022 and 18 radiation treatments in Jan2023. He/she had a complete response DLBCL and the CLL is not active but will return.   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-PV202300154339 same patient and drug, different vaccine dose/event;
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chronic lymphocytic leukaemia, Diffuse large B-cell lymphoma
Clinical narrative: had Covid; had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "had Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: I had Covid. Additional information: Description of Potential: Patient have received 6 doses of the Pfizer Covid vaccine. Patient had Covid in Dec2022. Patient was interested in participating in any trial that helps define the status of the immune system.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298565 same patient, different vaccine dose/event;
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: had Covid; had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "had Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: I had Covid. Additional information: Description of Potential: Patient have received 6 doses of the Pfizer Covid vaccine. Patient had Covid in Dec2022. Patient was interested in participating in any trial that helps define the status of the immune system.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298565 same patient, different vaccine dose/event;
Age: 35.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 36-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: few days later he felt a rebound of covid symptoms and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid.  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: COVID-19, Drug ineffective
Clinical narrative: NowI have COVID; NowI have COVID; 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), on 27Mar2021 at 14:30 as dose 1, single (Lot number: ER8733), in left arm and on 19Apr2021 at 14:30 as dose 2, single (Lot number: EN6203) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism", start date: 2017 (unspecified if ongoing); "pre-NASH" (unspecified if ongoing); "known allergies: possibly excipients in tablets" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing); "Vitamin D score was 11/ it was low" (unspecified if ongoing); "Bad tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sudafed, reaction(s): "known allergies:Sudafed"; Nickel, reaction(s): "known allergies: nickel". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "NowI have COVID".  Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid. Clinical course: mRNA shots ruined patient's life permanently. Now she had COVID and not realized Pfizer made Paxlovid, she took one dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300297843 Same patient, different drug and event;US-PFIZER INC-2021787750 Same patient, different vaccine dose and event;US-PFIZER INC-202101578013 Same patient, different vaccine dose and event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: vaccinated & boosted with Moderna & then 2 Pfizer; picked up COVID in Aug; picked up COVID in Aug; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 74-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "picked up COVID in Aug"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered", described as "vaccinated & boosted with Moderna & then 2 Pfizer". Clinical course: Patient was 74 fully vaccinated & boosted with Moderna & then 2 Pfizer vaccinations. Patient was picked up with COVID in Aug & still had it. patient was having concern if there were any research into the treatment.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac operation, Diabetes mellitus, Drug ineffective
Clinical narrative: he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19; he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19; diabetes; heart surgery; 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 male patient received bnt162b2 (BNT162B2), in 2022 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; CARDIAC OPERATION (non-serious), outcome "unknown", described as "heart surgery". Therapeutic measures were taken as a result of cardiac operation.  Clinical course: The caller mentioned that he is calling regarding the availability of the new COVID-19 vaccine, and he would also like to know where he can get it in his area. The caller also said that he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19. The caller would like to know if his wife can have the vaccine. The caller also stated that he had heart surgery and diabetes. I created two manual AE forms because his wife is in rehab and took the vaccine. Also, the caller had heart surgery and diabetes, and he also took the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: fluzone qiv administered to a pregnant with no reported adverse event; Initial information received on 06-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 25-year-old female pregnant patient who was exposed to vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent]  with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported fluzone qiv administered to a pregnant with no reported adverse event occurred at 37 weeks of pregnancy.  The date of last menstrual period was reported as 15-Dec-2022. The estimated due date is 22-Sep-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy.   On 06-Sep-2023, the pregnant patient received a dose 1 of suspect Influenza Quadrival A-B Vaccine Suspension for injection with unknown strength, batch number & expiry date via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation) with no reported adverse event (exposure during pregnancy) (latency: same day).  Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: temperature excursion 0.5 C and product was administered to patient with no reported adverse event; Initial information was received on 08-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA277620.  This case involves a 11 years old male patient to whom temperature excursion 0.5 c, meningococcal A-C-Y-W135 (T CONJ) vaccine  [Menquadfi] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-AUG-2023, the patient received an 0.5 ml, once dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot U7852AA, expiry date: 31-Oct-2025, strength: standard) via intramuscular route in Left deltoid for Immunization and temperature excursion 0.5 c, product was administered with no reported adverse event (poor quality product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Accidental exposure to product, Medication error, No adverse event
Clinical narrative: patient received a dose of QUADRACEL by mistake with no  reported adverse event; Initial information received on 08-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old female patient who received a dose of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] by mistake with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Sep-2023, the patient received a dose 0.5 ml of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine Suspension for injection expiry date: 07-sep-2024 lot U7526AA via unknown route in the left thigh for immunization and patient received a dose of quadracel by mistake with no  reported adverse event (accidental exposure to product) on the same day following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient received a dose of quadracel by mistake 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: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: ipol at Max/low temperature reached: 48.9F for 38 minutes with no reported adverse event; Max/low temperature reached: 48.9F was administered to the patient with no reported adverse event; Initial information received on 08-Sep-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient, for whom ipol at max/low temperature reached: 48.9f for 38 minutes with no reported adverse event and max/low temperature reached: 48.9f was administered to the patient 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 suspect IPV (VERO), Suspension for injection lot V1B891M, expiry: 27-Sep-2023 via unknown route in unknown administration site for immunization (strength, dose: unknown), max/low temperature reached: 48.9f was administered to the patient with no reported adverse event (poor quality product administered) (latency same4 day).  On an unknown date ipol at max/low temperature reached: 48.9f for 38 minutes with no reported adverse event (product storage error) (unknown latency).  This situation is due to human error.  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 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: M
Vaccine: FLU4
Symptoms: Fatigue
Clinical narrative: extremely tired; Initial information was received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (Patient).  This case involves an unknown age male patient who was extremely tired after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Suspension for injection) (strength, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic Vaccination (Immunization). The information on batch number was requested.  On an unknown date the patient developed extremely tired (fatigue) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported that " It is unknown to the reporter which specific Fluzone variant the consumer took. At the time of the report, the consumer took Fluzone about 4 days ago. "  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (extremely tired).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event extremely tired.
Age: 64.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Local reaction
Clinical narrative: Local injection site reactions consisting of erythema; Local injection site reactions consisting of induration; Local injection site reactions consisting of significant pruritus; This spontaneous case was received on 09-Sep-2023 from a healthcare professional (physician) (reference number SEQW23-02126) and concerned a 64-year-old, female patient.   The patient's medical history and concomitant medications were not reported. As reported, the patient had received annual flu vaccination over the past 20-30 years without any adverse events.   On 06-Sep-2023, the patient was vaccinated with  Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: arm, dose, route of administration, and indication: not reported). The batch number was not reported.  On the same date, after receiving the Flucelvax Quadrivalent, the patient experienced local injection site reactions consisting of erythema, induration, and significant pruritus.   At the time of the initial reporting, the patient had not recovered from the events of 'vaccination site erythema', 'vaccination site induration', and 'vaccination site pruritus'.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked to case 202303956 due to the same reporter.
Age: 64.0
Sex: F
Vaccine: FLUC3
Symptoms: No reaction on previous exposure to drug
Clinical narrative: Local injection site reactions consisting of erythema; Local injection site reactions consisting of induration; Local injection site reactions consisting of significant pruritus; This spontaneous case was received on 09-Sep-2023 from a healthcare professional (physician) (reference number SEQW23-02126) and concerned a 64-year-old, female patient.   The patient's medical history and concomitant medications were not reported. As reported, the patient had received annual flu vaccination over the past 20-30 years without any adverse events.   On 06-Sep-2023, the patient was vaccinated with  Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: arm, dose, route of administration, and indication: not reported). The batch number was not reported.  On the same date, after receiving the Flucelvax Quadrivalent, the patient experienced local injection site reactions consisting of erythema, induration, and significant pruritus.   At the time of the initial reporting, the patient had not recovered from the events of 'vaccination site erythema', 'vaccination site induration', and 'vaccination site pruritus'.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked to case 202303956 due to the same reporter.
Sex: U
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: not yet received the third dose; Drug dose administration interval too long; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on October 2017).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. In MAR-2018, the patient received the 2nd dose of Twinrix. In MAR-2018, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: not yet received the third dose).  The outcome of the drug dose administration interval too long and incomplete course of vaccination were 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: 31-AUG-2023 The pharmacist declined to provide details on the patient. The reporter was a pharmacist, reported a patient received the 1st dose of Twinrix October 2017, the 2nd dose March 2018,which led to the lengthening of vaccination schedule. Till the date of reporting the patient did not receive the 3rd dose, which led to incomplete course of vaccination. The patient did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: virus; virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 90-year-old female patient received bnt162b2 (COMIRNATY), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "virus". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal discomfort, Vomiting
Clinical narrative: PT experienced upset stomach, vomiting- lasting 24 hours
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient came into pharmacy and complained of his arm/injection site still being sore after the second dose. Arm is sore in the muscle and is a dull, achy pain. Patient showed me where it was sore and it was in the ideal spot for IM injection. Patient reports self massage and using ice. Pain is not severe but is bothersome. He was planning on getting with the doctor regarding this but had not had a visit yet.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Urticaria
Clinical narrative: Large Welp
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13
Symptoms: Pyrexia, Rash, Rash erythematous, Rash papular
Clinical narrative: Received Vaccine set on 7/21/023 with no preceding symptoms. Day after 7/22/2023 began to develop fevers at home. Appearing well otherwise, but mother of child was giving Tylenol with improvement of fevers. Developed red well delineated circular raised rash on bilateral cheeks. Never previously had this rash. Fevers continued intermittently for the next 48 hour then self resolved. Rash slowly resolved over the next 24 hours with no additional symptoms. Family did not seek medical attention as the patient symptoms resolved
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: My Immunization technician gave vaccine too high in the arm and he might hit her bone.  She has pain at the injection site for 2-3 weeks then it go away but it come back sometimes.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient reported a rash that extend from arm to abdomen
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine stored in unapproved storage unit
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine stored in unapproved storage unit.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Influenza Fluzone High Dose Quadrivalent vaccine which is labeled for 65 years and older. However, patient is only 63 years old. No known symptoms or signs at the time of submission of this report.
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Body temperature increased, Chest discomfort, Dyspnoea, Feeling hot
Clinical narrative: After patient return home, he experiences hotness to his face then started to get tightness in his chest. The next day patient went to the cardiologist appointment and was experiencing 104 temp with BP of 170/110 and still tightness of the chest and trouble breathing.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient was suppose to receive shingrix vaccine and immunizing technician performed appt vaccine without showing RPH on duty, technician administered pneumo20 and patient just received this shot last year
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Diarrhoea, Fatigue
Clinical narrative: Soon after the vaccine, I had a blinding headache, painful arm at injection site, fatigue, muscle aches, and nausea.   Eight days after the vaccine, I?ve had unrelenting nausea, intermittent stomach pain, diarrhea, and pain in muscles/joints. I?m so weak that I can barely walk.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Soon after the vaccine, I had a blinding headache, painful arm at injection site, fatigue, muscle aches, and nausea.   Eight days after the vaccine, I?ve had unrelenting nausea, intermittent stomach pain, diarrhea, and pain in muscles/joints. I?m so weak that I can barely walk.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Dizziness, Fatigue, Vertigo
Clinical narrative: Dizziness, Vertigo, Fatigue, Extreme joint pain in hips
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Pharmacist administered vaccine that had expired on 8/11/23. No adverse events reported by patient. He will repeat dose.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray abnormal, Chills, Differential white blood cell count abnormal, Dyspnoea, Electrocardiogram normal
Clinical narrative: The night of her booster vaccination, my mother developed chills, fever, body aches, vomiting, diarrhea, dry heaves, shortness of breath; had difficulty keeping food and water down, was unable to take her diuretic and cholestyramine.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Full blood count abnormal, Pain, Pulmonary oedema, Pyrexia, Retching
Clinical narrative: The night of her booster vaccination, my mother developed chills, fever, body aches, vomiting, diarrhea, dry heaves, shortness of breath; had difficulty keeping food and water down, was unable to take her diuretic and cholestyramine.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: The night of her booster vaccination, my mother developed chills, fever, body aches, vomiting, diarrhea, dry heaves, shortness of breath; had difficulty keeping food and water down, was unable to take her diuretic and cholestyramine.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bell's palsy, Facial paralysis, Tongue paralysis
Clinical narrative: Left-sided facial paralysis, tongue, lip.  Bell's palsey.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis, Hypoaesthesia, Pain, Product use in unapproved indication
Clinical narrative: Left-sided facial paralysis, tongue, lip.  Bell's palsey.
Age: 75.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Dysstasia, Magnetic resonance imaging, Pyrexia
Clinical narrative: Fever, could not stand up. Called EMTs taken to hospital. Kept overnight. MRI performed. They wanted to keep her another night and to another MRI, but she signed herself out. Dr stated he could find nothing wrong with her.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse reaction noted. See continuation page for explanation.On August 28, 2023, RN was preparing to administer a Menveo-meningococcal vaccine to a patient. She noted that there were 2 component/powder-Vial 1 and one Vial 2 component left in Menveo box. In inventory, it showed that there was 0-Menveo vaccine left after she administered that dose. After reviewing the barcode #1389665, 4 doses had been previously administered. Those 4 doses had been administered by 2 other RNs.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: No adverse events noted. See explanation on Continuation Page On August 28, 2023, a RN preparing to administer a Menveo meningococcal vaccine to a patient. She noted that there were 2 component/powder - Vial 1 and one vial 2 component left in Menveo box. In inventory, it shows that there was 0-Menveo vaccine left after she administered that dose. After reviewing the barcode #1389665, 4 doses had been previously administered. Those 4 doses had been administered by 2 other RNs. Each RN was questioned about mixing vials, but neither can remember if they had mixed vial 1 and vial 2. Dr was notified of incident and his recommendation was to contact parents of each patient and left know that each patient is covered on Meningococcal C, Y, and W-135 but not covered on Group A, which is not needed unless traveling outside of the country.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Joint range of motion decreased
Clinical narrative: Rt. deltoid/immunization site area is red,swollen, warm, tender to touch. "Painful". Has good neuro-circ. as well as sensory perception to RUE. Strong radial pulse. Guarded R.O.M. D/T pain. Swelling from immunization site to Rt. elbow. Area is marked with surgical marker and dated. Patient will monitor area. Will try ice and Motrin. Will report to the ER ASAP if he develops any worsening/changing S/S.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Rt. deltoid/immunization site area is red,swollen, warm, tender to touch. "Painful". Has good neuro-circ. as well as sensory perception to RUE. Strong radial pulse. Guarded R.O.M. D/T pain. Swelling from immunization site to Rt. elbow. Area is marked with surgical marker and dated. Patient will monitor area. Will try ice and Motrin. Will report to the ER ASAP if he develops any worsening/changing S/S.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Death, Nasopharyngitis, Vomiting
Clinical narrative: Pt c/o cold-like symptoms, excessive vomiting, etc.  Purchased cold-flu medication for  pt.  Pt worsened, taken to Medical Center on March 16th, admitted.  Pt worsened, death on March 23, 2021 @ approx. 1:40 pm.
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Pruritus, Skin abrasion, Skin haemorrhage, Urticaria
Clinical narrative: terrible allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "no problem"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "no problem"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "no problem"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "no problem". The following information was reported: HYPERSENSITIVITY (non-serious) with onset Sep2023, outcome "unknown", described as "terrible allergic reaction".  Additional information: Patient had all Pfizer vaccines and boosters with no problem. Until last week. Patient received a 3rd booster and had a terrible allergic reaction. Patient didn't know what was or different and neither does the health department.  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: COVID19-2, COVID19
Symptoms: Hypersensitivity
Clinical narrative: terrible allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "no problem"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "no problem"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "no problem"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "no problem". The following information was reported: HYPERSENSITIVITY (non-serious) with onset Sep2023, outcome "unknown", described as "terrible allergic reaction".  Additional information: Patient had all Pfizer vaccines and boosters with no problem. Until last week. Patient received a 3rd booster and had a terrible allergic reaction. Patient didn't know what was or different and neither does the health department.  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: 11.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Unevaluable event
Clinical narrative: No additional AE; a patient who was administered a fourth dose of MMR-II; This spontaneous report was received from an unspecified source on behalf of the patient referring to an 11-year-old patient of unspecified gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 06-SEP-2023, the patient was vaccinated with a fourth dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (extra dose administered) 0.5 ml/dose, lot # U039907, expiration date reported as 16-DEC-2023, and confirmed upon internal validation; administered as prophylaxis (strength, and route of administration were not provided). No symptoms reported. No additional adverse event (AE), nor product quality complaint was involved.
Age: 11.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; a patient who was administered a fourth dose of MMR-II; This spontaneous report was received from an unspecified source on behalf of the patient referring to an 11-year-old patient of unspecified gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 06-SEP-2023, the patient was vaccinated with a fourth dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (extra dose administered) 0.5 ml/dose, lot # U039907, expiration date reported as 16-DEC-2023, and confirmed upon internal validation; administered as prophylaxis (strength, and route of administration were not provided). No symptoms reported. No additional adverse event (AE), nor product quality complaint was involved.
Age: 69.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Chest pain, Dysgeusia, Electrocardiogram, Facial pain
Clinical narrative: Headaches; Numbness on one side of the head; Ears were whistling; Ear was irritated specially left one; Mouth was burning; Feeling very tired / Lot of fatigue; Irritated eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13, administration date: Aug2022, for immunization. The following information was reported: EAR PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "Ear was irritated specially left one"; TINNITUS (non-serious) with onset Sep2023, outcome "not recovered", described as "Ears were whistling"; FATIGUE (non-serious) with onset Sep2023, outcome "unknown", described as "Feeling very tired / Lot of fatigue"; HEADACHE (non-serious) with onset Sep2023, outcome "unknown", described as "Headaches"; EYE IRRITATION (non-serious) with onset Sep2023, outcome "not recovered", described as "Irritated eyes"; ORAL DISCOMFORT (non-serious) with onset Sep2023, outcome "recovering", described as "Mouth was burning"; HYPOAESTHESIA (non-serious) with onset Sep2023, outcome "unknown", described as "Numbness on one side of the head". The events "headaches", "numbness on one side of the head", "ears were whistling", "ear was irritated specially left one", "mouth was burning" and "feeling very tired / lot of fatigue" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient had Prevnar 20 on Friday, 01Sep2023 and the reactions were very awful. When the patient got the Prevnar 20, he experienced headaches, numbness on one side of the head, ears were whistling, ear was irritated specially left one, his mouth was burning, he was feeling very tired with a lot of fatigue. So, he went back to see the doctor but he was sent to the Nurse and the Nurse sent him to the emergency room (ER). At the emergency room, they did some lab work about five or six blood samples. The patient still has the symptoms, it has been over a week, but he still has the whistling sound in his ear. He still has irritated eyes. The burning in mouth went away but not completely. So, nobody was helping him because they do not seem to think this is an emergency, it does not help out. He wanted someone to take care of the symptoms that he got because it has been over a week.   The information on the batch/lot number pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.