chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dizziness, Fatigue, Malaise, Nausea, Pain in extremity
Clinical narrative: Caller's arm also hurt; dizziness; fatigue; nausea; for 2 weeks caller did not feel good; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (for 2 weeks caller did not feel good), PAIN IN EXTREMITY (Caller's arm also hurt), DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea) in an 81-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (had 3 previous Moderna COVID vaccines). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine. Concurrent medical conditions included Drug allergy (mostly to pain medication) and Allergy (A lot allergies).   On 11-Sep-2024, the patient received fourth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 11-Sep-2024, the patient experienced PAIN IN EXTREMITY (Caller's arm also hurt), DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea). In September 2024, the patient experienced MALAISE (for 2 weeks caller did not feel good). At the time of the report, MALAISE (for 2 weeks caller did not feel good) outcome was unknown and PAIN IN EXTREMITY (Caller's arm also hurt), DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-774934 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774934:neighbor's case
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: patient had only arm pain when taking vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (patient had only arm pain when taking vaccine) in a 72-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (patient had only arm pain when taking vaccine). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (patient had only arm pain when taking vaccine) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Every time she gets the vaccine she develops a low grade fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An elderly female patient received BNT162b2 (BNT162B2 NOS), 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 immunization, reaction(s): "low grade fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "low grade fever"; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "low grade fever"; Bnt162b2 nos (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "low grade fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Every time she gets the vaccine she develops a low grade fever".  Additional information: It was reported that every time she got the vaccine (COVID-19 Vaccine) she developed a low grade fever. Reported she was quite sick from it with a little bit of fever, really feeling like she was sick.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400271848 same patient, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: every time she gets the vaccine she develops a low grade fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose 7 (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, reaction(s): "low grade fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "low grade fever"; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "low grade fever"; Bnt162b2 nos (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "low grade fever"; Bnt162b2 nos (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "low grade fever"; Bnt162b2 nos (DOSE 6 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "low grade fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "every time she gets the vaccine she develops a low grade fever".  Additional Information: It was reported that every time she got the vaccine (COVID-19 Vaccine) she developed a low grade fever. Reported she was quite sick from it with a little bit of fever, really feeling like she was sick.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400271848 same patient, different dose and event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Tired; On the first vaccine the patient had, the patient was also very tired; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired; On the first vaccine the patient had, the patient was also very tired".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400272816 Same patient and product; different dose and event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Tired; On the first vaccine the patient had, the patient was also very tired; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired; On the first vaccine the patient had, the patient was also very tired".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400272816 Same patient and product; different dose and event;
Age: 68.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Cough, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: they gave me covid; real bad cough; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 03Oct2024 as dose number unknown, single) for influenza immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal; LISINOPRIL taken for blood pressure abnormal. The following information was reported: COUGH (non-serious) with onset Oct2024, outcome "not recovered", described as "real bad cough"; SUSPECTED COVID-19 (non-serious) with onset Oct2024, outcome "not recovered", described as "they gave me covid". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had COVID vaccine (Clarified as Pfizer COVID-19 vaccine) shot on 03Oct2024 (Thursday) and he is now experiencing symptoms of COVID. He also had the flu vaccine at the same time but his wife had the same two shots the day before, she has tested positive for COVID. he tested negative but he has the same symptoms as she does. He stated that his wife tested positive. He did not. This is with a home self kit, which are not professional, he stated. She tested positive and he did not. He only had the one line for the control line. So he did not but he has all the symptoms. He has the real bad cough and stuff like that. He remarked, why did he get a vaccine to prevent COVID and they gave him COVID.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400273141 same reporter/suspect vaccine; different patient/AE;
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had a covid vaccine; Tested positive for covid; Had a covid vaccine; Tested positive for covid; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 02Oct2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LISINOPRIL. The patient also took other concomitant therapy as the patient was taking blood pressure medicine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2024, outcome "unknown" and all described as "Had a covid vaccine; Tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2024) Positive. The patient tested positive for Covid with a home self kit.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400273035 same reporter/suspect vaccine; different patient/AE;
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Syncope; This is a spontaneous report received from a healthcare professional from a sales representative.  An adolescent patient received meningococcal serogroup B conjugate vaccine (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "unknown".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on known drug safety profile and limited information provided in the case, there is reasonable possibility of causal association between the event syncope and the suspect drug MENINGOCOCCAL GROUP B RLP2086. 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-202400273667 Same reporter/product/event, different patient;US-PFIZER INC-202400273671 Same reporter/product/event, different patient;
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Patient experienced syncope; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP from a sales representative and medical information team.  An adolescent patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 2022, outcome "unknown", described as "Patient experienced syncope".  The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event was related to the suspect product event most likely due to patient underlying contributory factors.  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-202400273664 Same reporter/product/event, different patient;US-PFIZER INC-202400273667 Same reporter/product/event, different patient;
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred.; Medical Assistant reported an AE for PROQUAD. The caller said the patient received a dose of PROQUAD after a temperature excursion. Confirmed no other AE occurred. AE letter sent to Medical Assistant. See AE cases 02683490, 02683500, 02683501, 026835; This spontaneous report has been received from a certified medical assistant (CMA), regarding a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.  On 01-OCT-2024, the patient was vaccinated with a improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA [recombinant Human albumin]) (PROQUAD), injection, 1 dosage form (reported as 1 dose), administered as prophylaxis (Lot No. y012074 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and upon internal validation established as 05-JAN-2026) (strength, dose number, exact dose quantity volume, route of administration, anatomical location of administration and vaccination scheme frequency were not provided) (product storage error), after a temperature excursion of 10.2 degree Fahrenheit (F) during a time frame of 1 hour and 30 minutes. No previous temperature excursion was reported.   Confirmed no other adverse event occurred (no adverse event).  This is one of few reports from the same reporter.; Sender's Comments:  US-009507513-2410USA001407:MSD US-009507513-2410USA001583:MSD US-009507513-2410USA001624:MSD US-009507513-2410USA001407:MSD US-009507513-2410USA001630:MSD US-009507513-2410USA001312:MSD US-009507513-2410USA001417:MSD US-009507513-2410USA001590:MSD US-009507513-2410USA001318:MSD US-009507513-2410USA001454:MSD
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; the vaccine was administered; This spontaneous report was received from health business professional (other), concerning to a patient of an unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) suffered a temperature excursion for 5 hours at 32.7 Fahrenheit (F). There was no previous temperature excursion reported.  On 30-SEP-2024, the patient was vaccinated with a dose of the vaccine that suffered the temperature excursion: rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally as prophylaxis; lot number y003996 has been verified to be valid for this vaccine, expiration date reported and confirmed as 27-APR-2025 (strength, dose and scheme were not provided). (Product storage error). No symptoms were reported and no additional adverse event (No adverse event).
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Patient experienced syncope/She has experienced 3 syncope events; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP from a sales representative and medical information team.  An adolescent female patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 2022, outcome "unknown", described as "Patient experienced syncope/She has experienced 3 syncope events". It was unknown if therapeutic measures were taken as a result of syncope.  The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event was related to the suspect product event most likely due to patient underlying contributory factors.  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-202400273664 Same reporter/product/event, different patient;US-PFIZER INC-202400273671 Same reporter/product/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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 (primary immunisation series complete), for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Sep2024, outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2024) Positive.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400272989 same patient, different dose, same event;
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; This is a spontaneous report received from an Other HCP.  A 30-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown), in arm and in 2020 as dose 2, single (Batch/Lot number: unknown) at the age of 29 years, in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE taken for migraine; NEXPLANON taken for contraception. Past drug history included: Codeine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "covid". Clinical course: Patient's trial doctor called her Dec2021 to said sorry they boosted when old had covid. There were no any other diagnosed illnesses/medical history/chronic health conditions to report. The patient was not received any other vaccines on the same date as the Pfizer vaccine. The patient was taking any other medications within 2 weeks prior to the event onset. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine.; Sender's Comments: Based on the information provided , temporal association and the known effects of the suspect drug, a possible contributory role of the suspect drug in triggering the onset of  the events Drug ineffective, COVID-19 cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202400118727 same reporter/patient, different dose/events;
Sex: M
Vaccine: MEN
Symptoms: Loss of consciousness, Seizure
Clinical narrative: passed out 3 separate times & had a seizure each time after he passed out; passed out 3 separate times & had a seizure each time after he passed out; Initial information received on 01-Oct-2024 regarding an unsolicited valid Social Media serious case received from a consumer/Non-Healthcare Professional.  This case involves an unknown age male patient who passed out 3 separate times & had a seizure each time after he passed out 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.   On an unknown date, the patient received a Booster dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) (strength, dose, batch number and expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient passed out 3 separate times & had a seizure each time after he passed out (loss of consciousness) (seizure) (unknown latency).  Reportedly, after event all right on the pediatricians floor. They brushed them off & Never followed up with them. He had last effects for months  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for both the events  Seriousness criteria-Medically significant and hospitalization for both events; Sender's Comments: Sanofi Company Comment dated 07-Oct-2024:This case involves an unknown age male patient who passed out 3 separate times & had a seizure each time after he passed out after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi]. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Incorrect dose administered
Clinical narrative: vaccine leaking out of the arm for the FLUZONE HD or the COVID-19 vaccine with no reported adverse event; Initial information received on 18-Sep-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age female patient who stated that vaccine leaking out of the arm for the Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] or the covid-19 vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect Covid-19 Vaccine not produced by Sanofi Pasteur formulation lot number not reported via unknown route in unknown administration site and also received a unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot number not reported via unknown route in unknown administration site for all Prophylactic vaccination (Immunization) and vaccine leaking out of the arm for the fluzone hd or the covid-19 vaccine with no reported adverse event (incorrect dose administered) (latency: same day) (strength, expiry date was unknown for both the suspects).  Reportedly "The Pharmacist reported that it is unknown which vaccine leaked due to the pharmacy did not know which vaccine was injected into each arm; that the vaccines were injected one vaccine into each arm; that the pharmacy was unable to let the consumer which arm received which vaccine; and that there is no information on the vaccines or consumer due to the event took place at another pharmacy. "   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: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: gave Fluzone HD to an under 65-year-old patient with no AE; Initial information received on 27-Sep-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves unknown age and gender adult patient who received  Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] as pharmacist gave Fluzone HD to an under 65-year-old patient with no 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 a  dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (unknown lot number, expiry date, dosage, strength and route) in unknown administration site for prophylactic vaccination as pharmacist Fluzone HD to an under 65-year-old patient with no Adverse event (product administered to patient of inappropriate age)  (latency-same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Caller mentioned that the patient was around 50 to 65 years of age  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: 0.5
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertent administration of quadracel to a patient instead of the prescribed pentacel with no reported adverse event; Initial information received on 27-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who had inadvertent administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel] instead of the prescribed diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel] 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 Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance) and Rotavirus vaccine for Immunisation.  On 27-Sep-2024, the patient had inadvertent administration of 0.5 ml  dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine, Suspension for injection (lot U7908AA; Expiration Date : 03-Oct-2025)via intramuscular route in the left thigh immunization instead of the prescribed Pentacel with no reported adverse event (wrong product administered) (latency same day).   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: 11.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 'FLUBLOK was inadvertently administered to a patient with No AE; Initial information received on 27-Sep-2024 regarding an unsolicited valid non-serious case received from Nurse.  This case was linked to 2024SA292674.  This case involves a 11-year-old female patient and reporter reported that inappropriate use due to the administration of the influenza trivalent recombinant vaccine [Flublok TIV] to patients not of age with no adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 21-Sep-2024 the reporter reported that inappropriate use due to the administration of the influenza trivalent recombinant vaccine Solution for injection (unknown strength) with dose 0.5 ml (lot: TFAA2421, expiry date: 31-May-2025) via Intramuscular in Right Deltoid for immunization, to patients not of age with no adverse event (product administered to patient of inappropriate age) (latency same day).   Reportedly, flublok was inadvertently administered to 2 different patients.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA292674:02241593
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: gave adacel subcutaneously to a patient with no reported adverse event; Initial information received on 27-Sep-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 48 years old male patient who was given diphtheria-2/tetanus/5 AC pertussis vaccine [ADACEL] subcutaneously 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 influenza vaccine (Fluzone); measles vaccine, mumps vaccine, rubella vaccine (MMR); and hepatitis B vaccine RHBSAG (yeast) (HEPLISAV B) all for Immunisation.  On 12-Sep-2024, the patient received 0.5 ml of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection in pre-filled syringe (strength- unknown, lot U8015AA and expiry date- 01-Mar-2026) once via subcutaneous route in the left arm for immunization with no reported adverse event (incorrect route of product administration) (latency- same day).  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: F
Vaccine: UNK
Symptoms: Pain, Swelling
Clinical narrative: Pain after administration of vaccine; Swelling after administration of vaccine; This spontaneous case, initially received on 04-Oct-2024, was reported by a non health professional and concerns a female patient.  No relevant medical history, Allergy Information was reported and concomitant medications was reported as unknown.  There was no product complaint associated with this case.  Administration of company suspect drug: On an unknown date, the patient received Afluria (TIV) for Flu immunization, Dosage: 0.5 ml, Lot number: AW1619A. Route of administration: Pre-filled syringe. CSL Seqirus Batch number unable to be matched with master batch list.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Pain after administration of vaccine (outcome: Unknown), Swelling after administration of vaccine (outcome: Unknown).  The patient reported that she didn't have any adverse reactions, only pain and swelling after administration of vaccine. Treatment measures associated with the events was unknown. Verbally informed the lot number provided was from Afluria Pre- filled Syringe.  Afluria (TIV) action taken: Not Applicable  Reporter's assessment: The reporter assessed the events as non-serious and did not provide a causality assessment.; Reporter's Comments: The events considered not related to the administration of Afluria (TIV).
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPIPV, FLU3, MMRV
Symptoms: Unevaluable event
Clinical narrative: Possible local reaction per Pediatric ID.
Age: 6.0
Sex: F
Vaccine: COVID19, FLUN3
Symptoms: Nausea, Vomiting
Clinical narrative: pt had nausea and vomiting after receiving 2 immunizations.  Pt was vomiting, gave pt ice pack, no allergic reaction sxs (no rash, itching, difficulty breathing).  Pt stayed in the pharmacy area for about an hour, then left after feeling better.  Pt reached out to their doctor who advised that they come in for an appointment.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient stated that he woke up in the middle of the night on 10/6/24 after receiving his Moderna booster. When he got out of bed he experienced intense, uncontrollable full-body shaking/tremors. The tremors lasted for "a few minutes" and then subsided with no recurrence. Patient wanted us to report the incident to VAERS.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Cardio-respiratory arrest, Crying, Haemorrhage, Musculoskeletal stiffness, Pallor
Clinical narrative: Pt was sitting on the exam room chair, received IM injection, started bleeding. As I was holding cotton to his arm, he started to look pale and turned to look over left shoulder. His body became stiff and he slumped down onto the ground. His mom and I were able to help him to the ground. He was not responsive for about 15 seconds, when he was first responsive, he grunted with his eyes closed. We were able to lay him back on the ground, and he was crying. An ice pack was placed on his neck after code blue was called. He was responsive by this time and he was able to tell me his name, his mom's name, and the day of the week. He was given water to drink and felt better, standing and walked out of clinic less than 5 minutes later.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Posture abnormal, Unresponsive to stimuli
Clinical narrative: Pt was sitting on the exam room chair, received IM injection, started bleeding. As I was holding cotton to his arm, he started to look pale and turned to look over left shoulder. His body became stiff and he slumped down onto the ground. His mom and I were able to help him to the ground. He was not responsive for about 15 seconds, when he was first responsive, he grunted with his eyes closed. We were able to lay him back on the ground, and he was crying. An ice pack was placed on his neck after code blue was called. He was responsive by this time and he was able to tell me his name, his mom's name, and the day of the week. He was given water to drink and felt better, standing and walked out of clinic less than 5 minutes later.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient has a red, palm sized rash at injection site
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Condition aggravated
Clinical narrative: Reported spike in blood sugar a few hours after receiving the vaccine (reading of 297). She only ate a light lunch and this was higher reading than normal.  We did speak with her later that evening around 7 pm and she said her blood sugar levels were within normal range. She had taken bolus doses of insulin to correct.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: About 48 hours after the COVID vaccination, I developed a cold sore near the left side of my mouth. I have not had a cold sore in about the last 20 years. It was in the same area as previous ones.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site induration, Injection site swelling, Paraesthesia
Clinical narrative: her arm became swollen, very red, hard to touch from shoulder to elbow and she complains of numbness and tingling to the elbow to the fingertips of the left arm.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was to receive the Moderna COVID19 vaccine for patients 6 months-11 years old, the nurse who was administering the vaccines grabbed the wrong formulation and the Pfizer vaccine was administered to the patient. She did not notice until after the patient and guardian and left.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Patient did receive a bandaide after administration of vaccine - she is allergic to adhesives.  About 30 minutes after administration, Patient observed 4 "hives" on each leg. She left a voice message for nurse who called her back the next day and left a voice message.  Nurse finally spoke with Patient on 10/11/24 - the rash/"hives" are gone.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Big red spot, hot to touch and can feel a distinct area where it is red
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Eye irritation, Eye pain, Eye swelling
Clinical narrative: Within 30 minutes of vaccine patient states left eye began swelling, burning, painful. The swelling, and pain did not stop. University clinic directed her to urgent care.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient received pediatric dose of Moderna vaccine instead of adult dose. No reported adverse events.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was given Fluad influenza vaccine for 65 years and older, pt is 59 years old.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Moderna 2024-2025 formulation vaccine instead of adult dose. No adverse events reported.
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Injection site reaction, Pain in extremity, Rash macular, Sleep disorder
Clinical narrative: On 10/11/2024 ~5 PM the patient called pharmacy. Reported that he had developed a blotchy roundish rash around the RSV site.  The arm has been sore. He was unable to sleep on the shoulder side where the injection was given. The rash was noticed the evening of 10/10/2024 it continues on 10/11/24.  Not worsening today.  No treatment noted at this time. The patient was instructed to seek medical care if he became short of breath or if his condition worsened.
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Pallor, Urinary incontinence
Clinical narrative: Tech gave Flu and Covid vaccine.   Tech asked rph for help in imz room.   Patient face was little pale and rph tried to talk to patient.   Patient responded and rph conversed with patient.   Rph asked if patient feel ok and he said ok.  rph asked if he wanted stay little more in the chair but he said ok and left.   Then rph and tech found chair was wet.   Rph and tech concluded somehow patient urinated little  on the chair.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness from cheekbone up to forhead that lasted  approx i hour.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Moderna vaccine instead of adult dose. No adverse events reported by patient
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Moderna vaccine instead of adult dose. No adverse events reported by patient
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received pediatric dose of Moderna vaccine instead of adult dose. Unable to reach patient
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Moderna vaccine instead of adult dose. No adverse events reported by patient
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure abnormal, Condition aggravated, Hypertension, Tachycardia
Clinical narrative: After the vaccine was administered, the patient indicated that he felt tachycardia and his blood pressure was taken, which was outside the normal ranges (high blood pressure). Patient continued with symptoms, EMS was called to be assisted.
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness
Clinical narrative: After the shot, the patient requested to wait in the vaccine room after the shot. She stated she gets nauseous after vaccines. After a few minutes, she requested to lay on the floor for a minute or two. She expressed she was feeling better and felt like she was okay to leave. A little bit later, a different customer walked in to let us know that a patient passed out in the parking lot and wanted to report it.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient received pediatric dose of Moderna vaccine instead of adult dose. No adverse events reported by patient
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Medical Assistant, me,  inadvertently grabbed a children's dose 0.25 mL vaccine, and mistook it for an adult dose Covid shot. I asked "is this good to use, but did not clarify I intended to give it to a man in his 40s. When I was told yes, I assumed it had been properly verified. Pt was informed and received second dose of Covid 0.25 mL dose later that day. No symptoms developed.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pain, Myalgia
Clinical narrative: Patient stated he has a knot and soreness where he received the vaccine then 48 hours he can not hardly raised his arm above his head with feeling like his muscle hurting or not working. I advised patient to do some arm therapy and ice pack for a few days to see will it get back to normal or else see a doctor.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Moderna vaccine instead of adult dose. No adverse events reported by patient
Age: 74.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO ADVERSE AFFECTS. REPORTING EVENT THAT PATIENT GOT A DUPLICATE FLUSHOT (FLUAD) 2 MONTHS APART.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immune thrombocytopenia
Clinical narrative: Development of ITP less than 24 hours after administration
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called and reported red and swollen injection site and a golf ball sized swelling just below the injection site of shingles (admin date 10/09/2024). recommended patient take tylenol for pain, benadryl for swelling and ice pack over the area for help with inflammation and swelling. Also, recommended patient to follow up with PCP if the symptoms don't start to get better in the next couple of days. Patient appreciated the information and consultation.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Patient has redness, warmth, tenderness and edema (not swelling) at injection site. Localized reaction - No cellulitis, no lymphangitis. No angioedema, no airway swelling, no shortness of breath. No hives.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pain
Clinical narrative: Patient reports a knot where he received the vaccine, extreme pain and inability to lift the arm.  Patient reports he is going to visit the emergency room  due to the pain and the inability to left his arm.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pt was administered the pediatric vaccine instead of the 12+ vaccine in error. No adverse events reported. Parent notified and was fine with no further vaccination
Age: 53.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Fall, Syncope
Clinical narrative: Patient received 2 vaccines, after the vaccines, the patient had no immediate reactions. Him and his wife were trying to convince his daughter to get the vaccine inside the vaccine room with me for about 15 minutes. When the family left, the pt fainted and fell on the floor. No apparent head injury. Pt was then led into the waiting room and given water and piece of candy. I monitored the pt for another 30 minutes. I offered to call EMS or get medical help but pt refused and said he was fine. After 30 minutes, the patient left with his family, conscious and alert and mobile.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was administered an extra dose of RSV, a year after getting the first dose in 9/2023.  As per CDC guidelines only one dose is to administered in a life time
Age: 89.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Cardiac monitoring, Decreased appetite, Dizziness, Electrocardiogram
Clinical narrative: exhausted                      loss of appetite very weak - sleepy          muscle weakness - legs - ect Ache in shoulder muscles  (GBS type feeling) lethergic heart-beating hard - Post   (Note: 10-9-24 - All symptoms gone - feel good! slight dizziness