chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 02Sep2022 as dose 2, single (Lot number: Fd7639), in left arm and on 01Nov2022 as dose 3 (orange cap; booster), single (Lot number: FF9442Z) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jan2023, outcome "unknown" and all described as "Covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jan2023) Positive, notes: Nasal Swab.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.,Linked Report(s) : US-PFIZER INC-202300272957 same patient, different dose/event;US-PFIZER INC-202300273027 same patient/drug, different dose/events (LOE);
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 37-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative on day 7; Positive, notes: by day 11 positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 01Jul2023 to 03Aug2023. The patient experienced rebound COVID-19 (symptoms never completely went away. Tested negative on day 7 and by day 11 positive again).   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 31Jul2023 to 04Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "known allergies: squid" (unspecified if ongoing), notes: Known allergies: Squid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: received Pfizer covid-19 vaccine and Moderna covid-19 vaccine; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 18Jul2023 at 11:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Batch/Lot number: unknown), in left leg, on 27Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pneumonia", start date: 1967 (unspecified if ongoing), notes: Pneumonia around 1967, age 14. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "received Pfizer covid-19 vaccine and Moderna covid-19 vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Still isolating for at least 3 more days, antigen testing & masking 8+ more days per guidelines. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 29Jul2023 to 03Aug2023. Additional information: the patient mentioned that finished Paxlovid 5-day treatment and felt fine though not 100% stamina due to recent Covid-19 bout. The patient mentioned that the patient remained isolated until Monday day 10 and that afternoon col-flu symptoms began. Next day (Tuesday), day 11 was worst day yet, other than original Day 1 when the patient first received diagnosis and began Paxlovid prescription. Still isolating for at least 3 more days, antigen testing & masking 8 plus more days per guidelines.  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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; Dose 1, 2, 3 (booster) received BNT162b2 then dose 4 and 5 received Moderna Biovalent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6207), on 03Apr2021 as dose 2, single (Lot number: ER8734) and on 06Oct2021 as dose 3 (booster), single (Lot number: FF2590) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 29Apr2022 as dose 4 (booster), single (Lot number: 059M21A) and on 21Oct2022 as dose 5 (booster), single (Lot number: 044D224), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Apr2022, outcome "unknown", described as "Dose 1, 2, 3 (booster) received BNT162b2 then dose 4 and 5 received Moderna Biovalent"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Aug2023) Negative; (09Aug2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 30Jul2023 to 03Aug2023.
Age: 54.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 6 (booster), single (Lot number: GH9697) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 30Jul2023 to 04Aug2023. The patient experienced rebound COVID-19 infection on 09Aug2023 at 08:00 PM.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including anti-virals Paxlovid from 03Aug2023 to 08Aug2023.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event (DRUG INEFFECTIVE, COVID-19) and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pcos" (unspecified if ongoing), notes: Polycystic ovary syndrome; "obesity" (unspecified if ongoing); "migraine" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: penicillin" (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 "Treatment of COVID-19". Therapeutic measures were taken included Paxlovid from 29Jul2023 to 03Aug2023 as treatment of COVID-19 and other medications included Advil Tylenol, Omeprazole, Mucinex.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune hepatitis, Biopsy liver, Fibrosis, Liver function test
Clinical narrative: Autoimmune hepatitis; Fibrosis; This is a literature report.   A 49-year-old female developed abnormal liver function tests after receiving a single dose of the Pfizer COVID-19 vaccine. Subsequent evaluation indicated autoimmune hepatitis with bridging fibrosis, confirmed by a liver biopsy. Treatment with prednisone and azathioprine resulted in a favorable biochemical response. Conclusion: The incidence of vaccine-induced liver injury is rare, but clinicians should be aware of this potential adverse effect. The benefits of COVID-19 vaccines outweigh the risks of liver injury. It remains unclear if the vaccine triggers an autoimmune response or leads to de novo autoimmune hepatitis. Further research with a greater sample is necessary to understand the underlying mechanism and identify risk factors. Additionally, determining the optimal duration of immunomodulatory treatment is crucial. Despite rare cases, the overall safety and efficacy of COVID-19 vaccines support their continued use in combating the pandemic.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate ,Linked Report(s) : US-PFIZER INC-PV202300138373 Same article/event/drug; different patient.;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective , Covid-19 and the use of suspect product cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: Intracranial mass, Magnetic resonance imaging, Pituitary tumour benign
Clinical narrative: 20mm mass that needs to be removed; pituitary tumors; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 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: INTRACRANIAL MASS (medically significant), outcome "unknown", described as "20mm mass that needs to be removed"; PITUITARY TUMOUR BENIGN (medically significant), outcome "unknown", described as "pituitary tumors". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (01Jul2020) 20mm mass, notes: had a 15 mm according to the report but according to my neurosurgeon it is a 20mm mass that needs to be removed; (06Mar2020) clear of my brain. Clinical course:The growth rate of that mass is really high were trying to figure out if it might be linked to the COVID-19 vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: 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, treatment: 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.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS-MANUFACTURER UNKNOWN), 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: THROMBOSIS (medically significant), outcome "unknown".; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the event thrombosis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300272365 Same article/drug/event, different patient;US-PFIZER INC-202300272367 Same article/drug/event, different patient;US-PFIZER INC-202300272366 Same article/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune hepatitis, Biopsy liver, Blood bilirubin, Hepatic enzyme, Investigation
Clinical narrative: Autoimmune hepatitis; This is a literature report.  A 67-year-old female, experienced significantly elevated liver enzymes and bilirubin levels after receiving four doses of the Pfizer COVID-19 vaccine. Liver biopsy revealed Grade 4 Stage 1 with lymphoplasmacytic infiltrate and interface hepatitis, consistent with autoimmune hepatitis and the patient was initiated on Prednisone, tapering down every 10 days. Upon completion of prednisone therapy, she started on Cellcept. She responded well to treatment and has been maintained on immunosuppressants. Chronic liver disease workup ruled out other underlying liver diseases. Conclusion: The incidence of vaccine-induced liver injury is rare, but clinicians should be aware of this potential adverse effect. The benefits of COVID-19 vaccines outweigh the risks of liver injury. It remains unclear if the vaccine triggers an autoimmune response or leads to de novo autoimmune hepatitis. Further research with a greater sample is necessary to understand the underlying mechanism and identify risk factors. Additionally, determining the optimal duration of immunomodulatory treatment is crucial. Despite rare cases, the overall safety and efficacy of COVID-19 vaccines support their continued use in combating the pandemic.; Sender's Comments: Based on the available information, a possible contributory role of the suspect product cannot be completely excluded for the reported event 'autoimmune hepatitis' due to a plausible temporal association.The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300273746 Same article/event/drug; different patient.;
Sex: U
Vaccine: TDAP
Symptoms: Accident at work, Skin laceration, Syringe issue
Clinical narrative: Tdap (Adacel) vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger; Tdap (Adacel) vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger; Initial information received on 03-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reporter reported Tdap [Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: U7869AA) (with an unknown strength, expiry date) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the reporter reported Tdap [Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger (skin laceration) (syringe issue) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the reported events.  Outcome: Unknown the reported event
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Blister, Erythema, Swelling
Clinical narrative: possible cellulitis; redness; severe swelling; blisters; Initial information was received on 08-Aug-2023 regarding an unsolicited valid serious case received from a other health professional.  This case involves 11 years old female patient who experienced possible cellulitis, redness, severe swelling and blisters after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.  On 31-Jul-2023, the patient received a dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot U763b2A, strength, expiry date unknown) via intramuscular route in unknown administration site for prophylactic vaccination (Immunization).  On 01-Aug-2023 the patient developed a serious event of possible cellulitis and non-serious events of redness (erythema) , severe swelling and blisters (blister) (latency: 1 day) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  There were no lab data/results available.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  It was not reported if the patient received a corrective treatment for the events (redness, severe swelling, possible cellulitis, blisters).  At time of reporting, the outcome was Recovered on 02-Aug-2023 for all the events.  Seriousness criteria : Medically significant for possible cellulitis.; Sender's Comments: Sanofi Company Comment dated 08-Aug-2023 : This case involves 11 years old female patient who experienced possible cellulitis, redness, severe swelling and blisters after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: daptacel vaccination instead of the adacel vaccination with no reported adverse event; Initial information received on 07-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11-year-old male patient who had DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] vaccination instead of the adacel vaccination with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Prophylactic vaccination.  On 04-Aug-2023, the patient received 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength: unknown) (lot: C5969AD, expiry date: 17-Feb-2024) via intramuscular route in the right deltoid for immunization.  On 04-Aug-2023, the patient had an event of daptacel vaccination instead of the adacel vaccination with no reported adverse event (wrong product administered) (latency: same day) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 10.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient who had received Quadracel at age 10 years old, which would be his 4th IPV dose, with no reported adverse event; Initial information received on 08-Aug-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 10 years old patient of an unknown gender who had received Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] which would be his 4th ipv dose, 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 an unknown dose of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine Suspension for injection (With an unknown expiry date, strength, lot number) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient received Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine which would be his 4th ipv dose, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, For a patient who had received Quadracel at age 10 years old, which would be his 4th IPV dose, would he need an additional dose of IPV or would the Quadracel count as his 4th dose. His 3rd IPV dose was given at age 6 months.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 70.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: staff member misinterpret expiration date on Tenivac it's listed as 24Jun23 staff member thought means June 23, 2024; vaccine was administered to a patient with no reported adverse event; Initial information received on 09-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 70 years old male patient who was administered expired diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Aug-2023, the patient received an expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, suspension for injection (batch number: U7092AA; expiry date: 24-Jun-2023) via intramuscular route in the left deltoid for Immunization (as the staff member misinterpret expiration date on tenivac it's listed as 24jun23 staff member thought means june 23, 2024) with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event staff member misinterpret expiration date on tenivac it's listed as 24jun23 staff member thought means june 23, 2024; vaccine was administered to a patient 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.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired daptacel was administered with no reported adverse event; Initial information received on 09-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional (Nurse).  This case involves a 2 months old female patient who was administered expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Aug-2023, the patient received 0.5 ml dose of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE with no reported adverse event (expired product administered) (latency : same day) (Suspension for injection) (Frequency = once), (Strength = standard) (lot C5893AA) via intramuscular route in left quadricep for immunization.  Action taken: Not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blindness, Blood glucose normal, Dizziness, Headache, Mydriasis
Clinical narrative: Patient reaction signs: - Pale skin - Loss of vision - Dizziness - Headache - Diluted eyes (per guardian)  - "Feeling like passing out" (per patient)   Nurse triage was needed to this interaction.    MAP was 64 Glucose was 110   Signs after 20 minutes: - Headache - Coloration returned - Patients states standing up might cause dizziness and feeling of passing out. - Vision returned   MAP was 69   PCP came in to room and discussed situation. PCP clarified not being vaccine reaction but vasovagal reaction. Patient verbalized understanding.    Patient was released from clinic with no abnormal signs at 2:55 PM.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pallor, Presyncope
Clinical narrative: Patient reaction signs: - Pale skin - Loss of vision - Dizziness - Headache - Diluted eyes (per guardian)  - "Feeling like passing out" (per patient)   Nurse triage was needed to this interaction.    MAP was 64 Glucose was 110   Signs after 20 minutes: - Headache - Coloration returned - Patients states standing up might cause dizziness and feeling of passing out. - Vision returned   MAP was 69   PCP came in to room and discussed situation. PCP clarified not being vaccine reaction but vasovagal reaction. Patient verbalized understanding.    Patient was released from clinic with no abnormal signs at 2:55 PM.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Blood in stool - speck. 1 day after vaccine and 1 week after vaccines. recurred with 1 episode of blood in stool after 4mo vaccines as well.
Age: 18.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event
Clinical narrative: No adverse symptoms observed/reported.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Insomnia, Irritability, Pyrexia, Rash, Rash macular
Clinical narrative: Fever for 5 days and rash of small red spots covering the body from the neck all the way down to the feet. Irritability and sleeplessness.
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Injection site pain, Malaise, Myalgia, Oropharyngeal pain
Clinical narrative: 8:00pm started feeling sick, started getting sore throat  Next morning around 7am very sore throat, beginning of muscle aches Slowly progressing throughout the day, tired, muscle aches, soreness at injection site, sore throat, possible fever (unable to confirm)
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Product administered at inappropriate site
Clinical narrative: Vaccinator may have given too low, below muscle tissue. Closer to insertion of deltoid rather than bulk of muscle. Redness showing, more anterior side.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: vaccine was used beyond use date and potency may be compromised
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: SHINGRIX 50MCG      INJ: I ADMINISTERED THE VACCINE TO THE PT AND THE PT CALLED LATER TO REPORT A BUMP AT THE INJECTING SITE. I RECOMMEND THAT THEY SEEK MEDICAL ATTENTION AND THEY DID. A doctor office called later to investigate about the vaccine. Pt had the bump that occurred earlier burst and the doctor office are treating the patient.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood test, Brain fog, Coordination abnormal, Dizziness
Clinical narrative: Loss of balance,coordination,brain fog, dizziness, tinnitus, nausea..
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gene mutation identification test, Magnetic resonance imaging head, Magnetic resonance imaging neck, Nausea, Nerve conduction studies
Clinical narrative: Loss of balance,coordination,brain fog, dizziness, tinnitus, nausea..
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Loss of balance,coordination,brain fog, dizziness, tinnitus, nausea..
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 3RD DOSE OF SHINGRIX GIVEN BY MISTAKE. PATIENT IS FINE WITH NO ISSUES. CALLED MANUFACTURER AND PER MANUFACTURER, PATIENT SHOULD HAVE NO ISSUES OTHER THAN NORMAL SIDE EFFECTS. PATIENT AND PATIENT'S DOCTOR ARE AWARE OF 3RD DOSE GIVEN.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC15, VARCEL
Symptoms: Pyrexia, Rash papular, Syncope
Clinical narrative: 8/9/23 fever 100.4 AX            faint pink blanching papular rash all over skin areas, most dense on buttock and back non urticarial Received two doses of Varicella
Age: 8.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Underdose
Clinical narrative: When medical technician gave simultaneously MMR/varicella into L thigh SQ patient's hand was not secured and he pushed needle out of skin. Full dose of vaccine was not given.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Carditis, Maternal exposure before pregnancy, Neuralgic amyotrophy, Optic neuritis
Clinical narrative: Pregnancy 2 years post Covid vaccine adverse reaction ie. Cardiac arrhythmias post cardiac inflammation, parsonage Turner syndrome, optic neuritis in the mother. Infant born with significant heart murmur female, 39 weeks gestation, 6lbs 13oz
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP reporting that PROQUAD was administered after it experienced a supported temperature excursion. No side effects reported from HBP.         ?    Names of vaccines involved (including lot/exp): PROQUAD, Lot: W036940, Expiration: 4/15/2024; This spontaneous report as received from an unspecified source also reported as "HBP" referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 12-JUL-2023, the patinet was vaccinated with a second dose of an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) RHA, which had a valid lot # W036940, at a dose of 0.5 milliliter, along with sterile diluent; for prophylaxis, however no adverse effects were reported.   Administered dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) experienced the temperature excursion below 8.6 degrees Celsius (-8.6C) for 51 minutes. Digital data logger was not involved. There were previous temperature excursions reported as: -11.5 C for 1 hour, 16 minutes, 0 seconds.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report an AE regarding VARIVAX. HCP calling to report that a patient was administered a improperly stored vaccine. Permission to contact HCP was provided. T.E case 02428709 filed. AE cases 02428861, 02428862, 02428779, 02428868, 024288; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 15-JUL-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # W031810, expiration date not provided but upon internal review stablished as 05-OCT-2024 (strength, route of administration, anatomical location not provided) as prophylaxis; which was improperly stored. No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report an AE regarding PROQUAD. HCP calling to report that a patient was administered a improperly stored vaccine. Permission to contact HCP was provided. T.E case 02428709 filed. AE cases 02428861, 02428862 ,02428865, 02428868, 024288; No additional AE; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date (reported as 13-JUL-2024), the patient was vaccinated with a dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # W035460, expiration date: 06-MAY-2024 (strength, route of administration, anatomical location not provided) as prophylaxis; which was improperly stored. No adverse event was reported.
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: CRT transfer customer who reports that an adult patient at their office was accidentally administered a pediatric dose of RECOMBIVAX HB. Consent given to follow up. She is requesting information on revaccination. No PQC. No additional information.; This spontaneous report was received from a Nurse and refers to a female adult patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 17-JUL-2023, the patient was accidentally vaccinated with a pediatric dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 0.5 mL (lot # W016842, expiration date: 19-NOV-2023) (route of administration, anatomical location not provided) as prophylaxis (incorrect dose administered).     .
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional AE; Inbound call from CMA who reports improperly stored MMR II was administered to 2 patients. See additional AE case 02429824 for additional patient. Excursion occurred 7/15/2023 and product was administered 7/17/2023.        ?    Names of vaccines in; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 15-JUL-2023, doses of vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # W039698, expiration date: 24-MAY-2024, underwent temperature excursion about 9 degrees Celsius (C) (14.0 C) during 30 hours. On 17-JUL-2023, the patient was vaccinated with this improperly stored vaccine which was reconstituted with diluent (not involved in temperature excursion), administered 0.5 mL, once (route of administration, anatomical location not provided) as prophylaxis. No adverse event was reported.      This is one of 2 cases reported by the same reporter.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improperly stored vaccine was administered; This spontaneous report was received from a nurse referring to an 18-month-old female patient. The patient's concurrent conditions and medical history were not reported. Concomitant medications included fluoride. Historical vaccines included hepatitis B vaccine (unknown manufacturer), measles mumps rubella vaccine live (unknown manufacturer), diphtheria vaccine toxoid (+) hib (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13), rotavirus vaccine live reassort oral 5v (ROTATEQ) and varicella zoster vaccine (unknown manufacturer).  On 23-JUN-2023, the patient was vaccinated with an improperly stored dose of hepatitis A Vaccine, inactivated (VAQTA) lot# X003791 and expiration date 01-JUN-2024 in the left thigh as prophylaxis (strength, dose, route, and vaccination scheme frequency were not provided). It was reported that vaccine temperature excursion was not viable and occurred from a digital data logger alarm believed to be due to sensory issues. Monitoring temperature with back up logger. Temperature in range, new data logger was in use. It was also reported a storage in clinical practice. There was no adverse effect reported.  The action taken with the vaccine was reported as "returned, waste in progress".   This is one of several cases by the same reporter.; Sender's Comments:  US-009507513-2308USA004788:Same Patient
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: HCP called regarding ROTATEQ. Product was administered to three different patients post TE.. Patient has not reported signs/symptoms of adverse effects.; HCP called regarding ROTATEQ. Product was administered to three different patients post TE.. Patient has not reported signs/symptoms of adverse effects.; This spontaneous report has been received from a nurse regarding a female patient.  The patient's medical history and concomitant therapies were not reported.   On an unspecified date, the patient received  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1968382, expration date 21-MAY-2024 (strength, dose were not provided). It was reported that the vaccine was administered post-temperature excursion (TE) (Improper storage of product in use), but the patient did not report any adverse event.  This is one of several reports received from the same reporter.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/ No PQC; Pharmacist called and informed a patient did not receive 1st dose of ROTATEQ until 8/2/2023.; This spontaneous report has been received from pharmacist, regarding a 6-months-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  Until 02-AUG-2023, the patient received the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, as prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported) (Product administered to patient of inappropriate age)  No additional adverse event was reported.