chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna, Date: 11Mar2021 / Pfizer, Date: 17Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Mar2021 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 allergy.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Dec2021, outcome "unknown", described as "Moderna, Date: 11Mar2021 / Pfizer, Date: 17Dec2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 07Aug2023 to 11Aug2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive Covid test after feeling unwell; Positive Covid test after feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Jan2023 as dose 1, single (Lot number: GJ6796) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2023 at 13:00, outcome "recovering" and all described as "Positive Covid test after feeling unwell". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2023) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 6 (booster), single (Lot number: GH9693) at the age of 70 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's relevant medical history included: "CLL stage zero (0)" (unspecified if ongoing). The patient's concomitant medications were not reported. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 03Aug2023 to 08Aug2023.   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: Demyelination, Multiple sclerosis relapse
Clinical narrative: demyelinating disorders onset/relapse after vaccine exposure/Multiple Sclerosis Relapse; demyelinating disorders onset/relapse after vaccine exposure; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization. The following information was reported: MULTIPLE SCLEROSIS RELAPSE (medically significant), outcome "unknown", described as "demyelinating disorders onset/relapse after vaccine exposure/Multiple Sclerosis Relapse"; DEMYELINATION (medically significant), outcome "unknown", described as "demyelinating disorders onset/relapse after vaccine exposure".; Sender's Comments: Based on the information in the case report, a possible causal relationship between the Multiple sclerosis relapse, Demyelination and suspect product BNT162b2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: her daughter got the covid shot and she ended up getting covid and got pretty sick with it; her daughter got the covid shot and she ended up getting covid and got pretty sick with it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the parent.  A female 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "her daughter got the covid shot and she ended up getting covid and got pretty sick with it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of ActHIB was inadvertently administered to a patient, administered on 14-Aug-2023 but expired on 13-Aug-2023 with no reported adverse event; Initial information was received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an expired dose of HIB (PRP/T) vaccine [ACT-HIB] was inadvertently administered to 1 years old female patient, administered on 14-Aug-2023 but expired on 13-Aug-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for Prophylactic vaccination.  On 14-Aug-2023, the patient received an expired dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (strength: standard, dose: Unknown) (lot number: UJ803AA, expiration date: 13-Aug-2023) via intramuscular route in unknown administration site for Immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of acthib was inadvertently administered to a patient, administered on 14-aug-2023 but expired on 13-aug-2023 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: 79.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: IPOL after it was mistaken for PPD test and administered as 0.1 mL intradermally with no adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 79-year-old male patient, IPV (VERO) [IPOL] after it was mistaken for ppd test and administered as 0.1 ml intradermally with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 14-Aug-2023, the patient received a 0.1 ml dose of suspect IPV (VERO) Suspension for injection (strength: unknown) (lot: W1A101M, 10-Feb-2025) via intradermal route in unknown administration site for Immunization and ipol after it was mistaken for ppd test and administered as 0.1 ml intradermally with no adverse event (wrong product administered) (latency: same day).  It was unknown if any lab data/test results available.  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) 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: 18.0
Sex: F
Vaccine: RAB
Symptoms: Product dose omission issue
Clinical narrative: Patient missed the schedule for her second dose of IMOVAX, with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old female patient who missed the schedule for her second dose of Rabies (Hdc) Vaccine [Imovax Rabies] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Aug-2023, the patient received a dose 1 (dosage text: once) of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection (Strength: standard, Frequency: once, expiry date and lot number not reported) via unknown route in unknown administration site of immunization. Information on the batch number was requested.   On 08-AUG-2023 the patient missed the schedule for her second dose of imovax, with no reported adverse event (routine immunisation schedule incomplete) (latency: 7 days).  It was reported that" Patient missed the schedule for her second dose of IMOVAX which was supposedly on 08AUG2023. Pharmacist was asking if it is okay to administer the second dose today and how will it affect the schedule of the third dose. Patient was not yet administered with the second dose during the call. "  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Electroencephalogram abnormal, Seizure
Clinical narrative: leg swelling; patient could not walk; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA250699.  This case involves a 3 years old female patient who experienced leg swelling and could not walk after receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past vaccination(s) included Rotavirus vaccine and Pentacel for immunisation. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection via unknown route in unknown administration site for prophylactic vaccination (Immunisation) (strength, dose, batch number and expiry date: unknown).  Information on the batch number was requested.  Reportedly, rotavirus vaccine, PENTACEL, and possibly Prevnar-13 (the patient's mother knew she received 3 vaccines, but as unsure if Prevnar-13 was the name of the 3rd vaccine); after these shots, the patient developed seizures. When the patient developed seizures. at night the patient would arch her back, her eyes would open, and her body would lock up. The patient was hooked up to electrodes, and they confirmed that they saw seizure activity. The seizure activity was off and on, and at one point it occurred every day for a couple of months. The patient's mother reports that since these events occurred after the patient received PENTACEL. The patient's mother reported that even with the individual vaccines (DAPTACEL, ACT-HIB), the patient still had some reactions like leg swelling; states that the patient could not walk after one of her shots  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.
Age: 64.0
Sex: F
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: patient receiving Menquadfi 8-9 days to earlier than it should have with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 64 years old female patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] 8-9 days to earlier than it should have 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 (CRM197) (Menveo) for Prophylactic vaccination (Immunisation).  On an unknown date, the patient received a dose of 0.5 ml of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot number; expiry date; strength not reported) via unknown route in unknown administration site for Immunization.  Information regarding batch number will be requested in the case.   On an unknown date the patient received menquadfi 8-9 days to earlier than it should have with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  It was reported, "RN inquiring if a patient that received menquadfi how long is the waiting period until the patient receives a second dose."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired ACTHIB was administered to a patient with no reported adverse event; Initial information received on 16-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 for whom an expired haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Aug-2023, the patient received an expired total dose of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ787AAA, expiry date- 11-AUG-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: product was given to patient, but it was expired with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender to whom vaccinated with HIB (PRP/T) VACCINE [ACT-HIB] , but it was expired 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 a unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength, expiry date and lot number not reported) via unknown route for immunization and but it was expired with no reported adverse event (expired product administered) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: Product dose omission issue
Clinical narrative: patient missed their scheduled dose, patient has received her second dose on 03Aug2023 and forgot to follow up on her succeeding doses with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient and reporter reported patient missed their scheduled dose of Rabies (Hdc) Vaccine [Imovax Rabies], patient has received her second dose on 03aug2023 and forgot to follow up on her succeeding doses with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Aug-2023, the patient received  Dose 2 of suspect RABIES (HDC) VACCINE Powder and solvent for suspension for injection (with an unknown strength, lot number and expiry date) via unknown route in unknown administration site for immunization.   On an unknown date, the reporter reported reporter reported patient missed their scheduled dose of Rabies (Hdc) Vaccine [Imovax Rabies], patient has received her second dose on 03aug2023 and forgot to follow up on her succeeding doses with no reported adverse event (routine immunisation schedule incomplete) (unknown latency).  It was reported, A nurse asks about the recommended dose scheduling adjustment for IMOVAX if the patient missed their scheduled dose, patient has received her second dose on 03Aug2023 and forgot to follow up on her succeeding doses; Agency provided information; patient information unavailable. No additional information. This is reported as a medication error due to a patient missing a scheduled dose from the IMOVAX series. No additional information.  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: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered a dose of Adacel that expired on 04Mar2023 with no adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 years and 9 months old female patient who was administered a dose of diphtheria-2/ tetanus/ 5 AC pertussis vaccine [Adacel] that expired on 04mar2023 with no 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 (with either Menactra or Menveo) for Immunisation.  On 19-Jul-2023, the patient received 0.5 mL dose of expired suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: U6969AB; expiry date: 04-Mar-2023) via intramuscular route in the right deltoid for Immunization with no adverse event (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered a dose of adacel that expired on 04mar2023 with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: giving an expired dose of ACT-HIB with no advese event; Initial information was received on 17-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 34 years old patient of unknown gender who received an expired dose of hib (prp/t) vaccine [Act-hib] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine (Polio) for Prophylactic vaccination; hpv vaccine vlp rl1 4v (yeast) (Gardasil) for Prophylactic vaccination (immunisation); and pneumococcal vaccine conj 7v (crm197) (Prevnar) for Prophylactic vaccination (Immunisation).  On 16-Aug-2023, the patient received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection at dose of 0.5 ml (strength: standard) (lot number: UJ803AA, expiration date: 13-Aug-2023) via intramuscular route in the left deltoid for Immunization (immunisation) with no adverse event (expired product administered) (latency: same day).   No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event giving an expired dose of act-hib.  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: FLUA4
Symptoms: Unevaluable event
Clinical narrative: Received a flu vaccine just prior to their admission; This spontaneous case was received on 11-Aug-2023, from a pharmacist (reference number: SEQW23-01695) and concerned a patient of an unreported age and gender.   The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location, and indication: not reported). The batch number reported was 370269.   On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, the patient was admitted to the hospital. It was not reported if the patient was discharged from the hospital.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.   The event was considered as serious due to the seriousness criterion of hospitalization.  Company comment: A patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after vaccination, the patient was admitted to the hospital. Lack of information was provided regarding the reason for hospitalisation. It was not reported if the patient was discharged from the hospital. The patient's medical history and concomitant medications were not reported. Information regarding relevant laboratory findings and diagnostic data was not provided. Causal role of the suspect vaccine is unassessable for the event hospitalisation, due to lack of information provided.; Sender's Comments: A patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after vaccination, the patient was admitted to the hospital. Lack of information was provided regarding the reason for hospitalisation. It was not reported if the patient was discharged from the hospital. The patient's medical history and concomitant medications were not reported. Information regarding relevant laboratory findings and diagnostic data was not provided. Causal role of the suspect vaccine is unassessable for the event hospitalisation, due to lack of information provided.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Nausea
Clinical narrative: Extreme tiredness  Slight nausea
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Influenza virus test negative, Nausea, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Pt developed nausea, vomiting, and diarrhea that improved.
Age: 10.0
Sex: F
Vaccine: DTPPVHBHPB, MMRV, TDAP, DTPPVHBHPB, MMRV, TDAP
Symptoms: Unevaluable event
Clinical narrative: Attempt to reach parent with assistance of interpreter to check on patient. Left message to call to the office.
Age: 10.0
Sex: F
Vaccine: DTPPVHBHPB, MMRV, TDAP, DTPPVHBHPB, MMRV, TDAP
Symptoms: Product use issue
Clinical narrative: Attempt to reach parent with assistance of interpreter to check on patient. Left message to call to the office.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Patient experienced dizziness, diaphoresis and syncope following vaccine. Patient regained consiousness within 30 seconds. Placed in supine position with cool packs on neck and forehead. Patient slowly transitioned over 45 minutes from supine to standing and left office under own power. BP 100/60 p 60 in supine position. 80/52 p 88 standing
Age: 50.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Cough, Deafness unilateral, Hypotension, Nausea
Clinical narrative: Patient with cough, low blood pressure, nausea, she said she could not hear nothing left ear.  An alcohol was given and she sniff it and blood pressure was monitored.  started at 3:10 pm and felt very good walking with no symptoms however she and her family was told to have caution take acetaminophen for fever and pain and benadryl if rash appear,  also observation if needed to take to ER..
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm site redness and swelling
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site pain, Injection site swelling, Pain
Clinical narrative: Soreness in left deltoid region felt late Friday night (8/18/23).  As the weekend progressed, the soreness grew.  It is uncomfortable to raise the arm and move around.  There is noticeable swelling in the left deltoid compared to the right (dominant arm) and there is a palpable lump that was not felt before.  Immediately after vaccination, there was superficial swelling into the inject safe bandage used when the bandage was removed that night.  Otherwise, no issues (no soreness, swelling, itching, etc)  with vaccination until  8/18/23.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: PT COMLAINT REDNESS AND WARM AROUND INJECTION SITE THE DAY AFTER, PHARMACIST EXAMED AND NOT ABLE TO TELL IF IT'S DUE TO ADVERSE REACTION OR CELLULITIS, INSTRUCTED PT TO CONTACT MEDICAL DOCTOR
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Neuritis, Pain, Sleep disorder
Clinical narrative: Continued pain and limited range of motion that has impacted her ADLs, as well as sleep. This has persisted with no improvement for 5+ days. Diagnosed with axillary neuritis.
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID shot after beyond use date.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED A COVID DOSE AFTER BEYOND USE DATE OF 12/17/2022.
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED A COVID DOSE AFTER BEYOND USE DATE OF 12/17/2022.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED A COVID DOSE AFTER BEYOND USE DATE OF 12/17/2022.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED A COVID DOSE AFTER BEYOND USE DATE OF 12/17/2022.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Blood test, Breast pain, Cardiac dysfunction, Computerised tomogram
Clinical narrative: Sleep 12-14 hours a day/night. Cannot stop sleeping. Lost 11 lbs. in 13 days. I continue to hold fluid. Breasts very sore. Cannot touch nipples. Cannot take NALTRELONE OR IVERMECTIN. My skin breaks out with sores on head, wart like bumps all over my body. This has been going on for 13 weeks. Feel like I have a fever at times. Temp goes to 99.0. Having frequent headaches. Feels like a flu headache. My heart function is at 50%. It actually got better. I have cut my BP medicine in 1/2 per dr. On 5/17, I was very tired and itched all over. It as if I have backward in symptoms for my whole like in these 13 weeks. Symptoms except for sleep keep changing. At first, I felt very weak. Then I had about a month of violent shaking. Recently, Lyme reared its ugly head. I have tried to record all my symptoms but I know I forgot some. I cannot express how bad I fel. I have horse breeding farm & I can't do it anymore. I don't have help. Now my voice is being affected.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphonia, Echocardiogram, Electrocardiogram, Fatigue, Feeling abnormal
Clinical narrative: Sleep 12-14 hours a day/night. Cannot stop sleeping. Lost 11 lbs. in 13 days. I continue to hold fluid. Breasts very sore. Cannot touch nipples. Cannot take NALTRELONE OR IVERMECTIN. My skin breaks out with sores on head, wart like bumps all over my body. This has been going on for 13 weeks. Feel like I have a fever at times. Temp goes to 99.0. Having frequent headaches. Feels like a flu headache. My heart function is at 50%. It actually got better. I have cut my BP medicine in 1/2 per dr. On 5/17, I was very tired and itched all over. It as if I have backward in symptoms for my whole like in these 13 weeks. Symptoms except for sleep keep changing. At first, I felt very weak. Then I had about a month of violent shaking. Recently, Lyme reared its ugly head. I have tried to record all my symptoms but I know I forgot some. I cannot express how bad I fel. I have horse breeding farm & I can't do it anymore. I don't have help. Now my voice is being affected.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Hypersomnia, Impaired work ability, Nipple pain, Pruritus
Clinical narrative: Sleep 12-14 hours a day/night. Cannot stop sleeping. Lost 11 lbs. in 13 days. I continue to hold fluid. Breasts very sore. Cannot touch nipples. Cannot take NALTRELONE OR IVERMECTIN. My skin breaks out with sores on head, wart like bumps all over my body. This has been going on for 13 weeks. Feel like I have a fever at times. Temp goes to 99.0. Having frequent headaches. Feels like a flu headache. My heart function is at 50%. It actually got better. I have cut my BP medicine in 1/2 per dr. On 5/17, I was very tired and itched all over. It as if I have backward in symptoms for my whole like in these 13 weeks. Symptoms except for sleep keep changing. At first, I felt very weak. Then I had about a month of violent shaking. Recently, Lyme reared its ugly head. I have tried to record all my symptoms but I know I forgot some. I cannot express how bad I fel. I have horse breeding farm & I can't do it anymore. I don't have help. Now my voice is being affected.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Tremor, Weight decreased
Clinical narrative: Sleep 12-14 hours a day/night. Cannot stop sleeping. Lost 11 lbs. in 13 days. I continue to hold fluid. Breasts very sore. Cannot touch nipples. Cannot take NALTRELONE OR IVERMECTIN. My skin breaks out with sores on head, wart like bumps all over my body. This has been going on for 13 weeks. Feel like I have a fever at times. Temp goes to 99.0. Having frequent headaches. Feels like a flu headache. My heart function is at 50%. It actually got better. I have cut my BP medicine in 1/2 per dr. On 5/17, I was very tired and itched all over. It as if I have backward in symptoms for my whole like in these 13 weeks. Symptoms except for sleep keep changing. At first, I felt very weak. Then I had about a month of violent shaking. Recently, Lyme reared its ugly head. I have tried to record all my symptoms but I know I forgot some. I cannot express how bad I fel. I have horse breeding farm & I can't do it anymore. I don't have help. Now my voice is being affected.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED A COVID DOSE AFTER BEYOND USE DATE OF 12/17/2022.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse food reaction, Lip blister, Oral discomfort, Oral mucosal blistering, Pain
Clinical narrative: 7/9/21 - developed burning blisters on tongue, lips inside of mouth after eating dish w/ pepper. Thought it was pepper at first. Universe of foods causing reaction widened. Now - cannot eat refined sugar, any spice, dairy or gluten. Lost a lot of weight- down to 108lbs  painful every day went to 2 primary care physicians another MD Homeopathy MD Naturo path osteopath acupuncturist reflexologist chiropractor applied kinesiologist  (I'm not sure it is vaccine related but my sister is convinced made me promise to file a report.)  Blessings to all of you working for public health! Hope simeine does something nice for you today!
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue blistering, Tongue discomfort, Weight decreased
Clinical narrative: 7/9/21 - developed burning blisters on tongue, lips inside of mouth after eating dish w/ pepper. Thought it was pepper at first. Universe of foods causing reaction widened. Now - cannot eat refined sugar, any spice, dairy or gluten. Lost a lot of weight- down to 108lbs  painful every day went to 2 primary care physicians another MD Homeopathy MD Naturo path osteopath acupuncturist reflexologist chiropractor applied kinesiologist  (I'm not sure it is vaccine related but my sister is convinced made me promise to file a report.)  Blessings to all of you working for public health! Hope simeine does something nice for you today!
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Skin discolouration
Clinical narrative: Swelling, itching, pain at injection site for 2 weeks. Has a dark discolored area on posterior left arm at the injection site (Not a bruise). Sterile diluent lot: W032818. Received vaccine due to a negative varicella titer drawn for employee health.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Swelling at injection site. Has a dark discolored area on posterior left arm at the injection site (Not a bruise). Steril diluent lot: W032818. Received vaccine due to a negative varicella titer drawn for employee health.
Age: 13.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Laboratory test normal, Seizure
Clinical narrative: Patient came to get vaccinations with her mother, brought prescriptions from her provider. She was due for Engerix B, Boostrix, Menveo, & Havrix. I started vaccinating with Engerix B & Boostrix in one arm. I then gave her menveo on the other arm, soon as I finished patient convulsed for about 15 seconds. No treatment called EMS, test good patient left home with parents
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Asthenia, Erythema, Fatigue, Pyrexia, Rash macular
Clinical narrative: leg was red, elevated dots, low energy, tired, fever
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: The MMR went out of temperature to 55.4F and the manufacture said to not give it and we did before knowing it was not useable.
Age: 1.25
Sex: M
Vaccine: PNC15
Symptoms: Brain scan abnormal, Cerebral arteriovenous malformation haemorrhagic, Endotracheal intubation, Intracranial aneurysm, Mental status changes
Clinical narrative: Patient was seen for his 15 mos 7/6/23, given PCV15. On 7/7/23 AM, patient was seen w/altered mental status, in vomit on his crib. Mom called EMS + was brought at the ER. He had seizures at the ER. Brain imaging showed bleed from AVM/aneurysm.  Presently intubated and on anticonvulsants.
Age: 1.25
Sex: M
Vaccine: PNC15
Symptoms: Seizure, Vomiting
Clinical narrative: Patient was seen for his 15 mos 7/6/23, given PCV15. On 7/7/23 AM, patient was seen w/altered mental status, in vomit on his crib. Mom called EMS + was brought at the ER. He had seizures at the ER. Brain imaging showed bleed from AVM/aneurysm.  Presently intubated and on anticonvulsants.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Resident was found unresponsive and asked this nurse to come assess, after checking resident there was no audible or visual signs of life. Every party notified and body released to Funeral Home. Waiting for funeral home personnel to pick up.
Sex: F
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: None stated.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: PATIENT WAS GIVEN COVID VACCINE AFTER BEYOND USE DATE OF 12/17/2022
Age: 57.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Diarrhoea, Product administration error, Pyrexia
Clinical narrative: MODERNA + PREVNAR 20 WERE ADMINISTERED TO THE INCORRECT PATIENT. NO ADVERSE SIDE EFFECTS UPON IMMEDIATE INJECTION. PATIENT + DR AWARE. PT STAYED FOR ADDITIONAL OBSERVATION. PT LEFT AMBULATORY OUT OF OFFICE. Addendum by MD, on June 30, 2023 12:26:13 EDT (Verified) She was supposed to receive TDaP. I discussed the mix up with pt using the video interpreter service. Apologies extended  I advised pt that although the vaccines given were in error as she is about to start immunosuppressive therapy with Otezla a second bivalent covid booster is in line with current CDC recommendations as it relates to persons with a compromised Immune system  I advised pt that because she mentioned having diarrhea and a fever for several days with the initial bivalent booster and seemed resistant to receiving covid shots going forward I did not press the issue. Pt also informed that all of her previous covid were Pfizer brand however mixing and matching btwn Pfizer and Moderna brands approved by FDA.  We also discussed that she received a second Prevnar20, the initial vaccine was given 6mths prior.  Pt advised that she is unlikely to develop any adverse effects related to vaccines given other than similar symptoms developed following previously administered bivalent booster.  Pt was allowed to ask questions, she stated she was ok and requested that her covid card be updated.  I  informed pt to wait 2wks before starting the Otezla to ensure her body mounts a good immune response to vaccines given.  Pt agreeable.  Pt will f/u with me in 3wks but , If she any concerns/ ?'s develop In the meantime she is  to call the office.  Clinical supervisor Informed of Incident SRS filed. SARS-CoV-2 (COVID-19) mRNA BNT-162b2 vac 01/21/2022 SARS-CoV-2 (COVID-19) mRNA BNT-162b2 vac 04/27/2021 SARS-CoV-2 (COVID-19) mRNA BNT-162b2 vac 04/06/2021
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Biopsy breast abnormal, Breast necrosis, Condition aggravated, Electrocardiogram abnormal
Clinical narrative: Patient with Afib, withe exacerbation of it after last Covid Moderna vaccine in August/12/2022, now with 2% afib burden. Recently diagnosed with Ductal carcinoma in situ, right breast.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Intraductal proliferative breast lesion
Clinical narrative: Patient with Afib, withe exacerbation of it after last Covid Moderna vaccine in August/12/2022, now with 2% afib burden. Recently diagnosed with Ductal carcinoma in situ, right breast.
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED A COVID DOSE AFTER BEYOND USE DATE OF 12/17/2022.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Mental status changes, SARS-CoV-2 test negative, Unresponsive to stimuli
Clinical narrative: Due to COVID outbreak at facility, resident was tested for COVID in house on 6/8/2023, Results were negative. Resident sent to hospital 6/11/2023, was diagnosed with COVID. 77-year-old gentleman with past medical history significant for ischemic heart disease, adult failure to thrive, epilepsy, diabetes mellitus, recurrent falls among others referred to my service having been brought to the ER unresponsive. HPI review of systems unobtainable due to altered mental status Patient passed away prior to my evaluation
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child was given 6mo-4yr Bivalent covid - no reactions were present
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Child was given 6mo-4yR Bivallent COVID - no reactions were Present.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED A COVID DOSE AFTER BEYOND USE DATE OF 12/17/2022.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: PATIENT WAS GIVEN COVID VACCINE AFTER BEYOND USE DATE OF 12/17/2022.
Age: 78.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Aphasia, Guillain-Barre syndrome, Influenza like illness, Laboratory test abnormal, Muscular weakness
Clinical narrative: Patient came in for both the flu and shingles vaccines and had mild flu like symptoms the following day according to her daughter. On the 6th night (8/17) patient woke up and her legs felt like "jello" since she was unable to move them. The daughter said she was admitted into the ED that night. The patient progressively got worst as now she is unable to move her arms and her speech is now being affected. Her daughter said the providers ran tests to figure out what the cause was and perform a Guillain-Barre syndrome exam which came back positive
Age: 78.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Musculoskeletal disorder, Speech disorder
Clinical narrative: Patient came in for both the flu and shingles vaccines and had mild flu like symptoms the following day according to her daughter. On the 6th night (8/17) patient woke up and her legs felt like "jello" since she was unable to move them. The daughter said she was admitted into the ED that night. The patient progressively got worst as now she is unable to move her arms and her speech is now being affected. Her daughter said the providers ran tests to figure out what the cause was and perform a Guillain-Barre syndrome exam which came back positive
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID shot after beyond use date OF 12/17/2022.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED A COVID DOSE AFTER BEYOND USE DATE OF 12/17/2022
Age: 87.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Neck pain, Odynophagia
Clinical narrative: Neck pain & pain w/ swallowing on 8/19/23 AM went away 8/21/23