chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MMRV, UNK
Symptoms: Device connection issue, No adverse event, Syringe issue
Clinical narrative: She states the patient did not report any adverse events; 1 of the syringes broke after the dose was administered to a patient.; The patient received a full dose but the needle and syringe hub/luer lock was left in the patient's leg.; This spontaneous report has been received from an office manager, regarding a child male patient of unreported age. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 14-AUG-2024, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot number: X022922, which was determined to be valid, with an expiration date on 12-MAR-2025. Therapy type: rHA) (strength, dose, scheme and route and anatomical location were not reported) plus sterile diluent (STERILE DILUENT) solution for injection/infusion, at a dose of 0.5 milliliters (lot number: 1973244, which was determined to be valid as syringe formulation, with an expiration date on 01-MAR-2026) (strength, route and anatomical location of administration were not reported), in the leg (not specified) as prophylaxis.  It was reported that the patient received the full dose, but the syringe broke (syringe issue) and the needle and syringe hub/luer lock were left in the patient's leg (Needle issue, Poor quality device used).  The reporter stated the patient did not report any adverse events.  Apart from this syringe, two other, all from the same box, were affected and broke at the neck of the syringe- at the base of the syringe barrel and above the hub/luer lock while the nurses were removing the syringe from the vial after reconstitution.   No additional information was reported. No one was injured as a result of the breaks.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/getting shingles; getting shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included cholesterol.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 6 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/getting shingles) (serious criteria GSK medically significant) and shingles (Verbatim: getting shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. The company considered the shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 14-AUG-2024 The patient reported even after booster shots the patient getting shingles. The patient had gotten it three times after shots this was in a period of a year and half. The symptoms were not treated.  This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure  is a listed event which is considered related to GSK vaccine  Shingrix (1st dose)and Shingrix(2nd dose).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingrix vaccinated patients still contracted mild cases of Shingles.; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingrix vaccinated patients still contracted mild cases of Shingles.). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt date: 15-AUG-2024 A physician reported that Shingrix vaccinated patients still contracted mild cases of Shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Incomplete course of vaccination, Muscle spasms, Refusal of vaccination
Clinical narrative: Cramps in legs; Numbness in toes; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of leg cramps in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 14-JUN-2024, an unknown time after receiving Shingrix, the patient experienced leg cramps (Verbatim: Cramps in legs) and numbness in toes (Verbatim: Numbness in toes). Shingrix was discontinued. On 17-JUN-2024, the outcome of the leg cramps was resolved. The outcome of the numbness in toes was not resolved.   The reporter considered the leg cramps and numbness in toes to be related to Shingrix.     The company considered the leg cramps and numbness in toes to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-AUG-2024 The patient received initial dose of Shingrix. The other health professional reported that, the patient came in for appointment for second dose and alerted provider of leg cramps and numbness in left great toe.  The patient refused second dose.
Sex: M
Vaccine: COVID19, FLU4
Symptoms: COVID-19, Cough, Fatigue, Lacrimation increased, Rhinorrhoea
Clinical narrative: mild fatigue,; contracted Covid starting Friday 02-Aug and tested positive; mild runny nose; watery eyes; Cough; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of fatigue in a male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) for prophylaxis.   Co-suspect products included Tozinameran (Comirnaty) for prophylaxis.   Concurrent medical conditions included asthma and drug allergy.   On 30-SEP-2023, the patient received Fluarix Tetra 2023-2024 season (left arm) and Comirnaty (right arm). On 02-AUG-2024, 307 days after receiving Fluarix Tetra 2023-2024 season, the patient experienced fatigue (Verbatim: mild fatigue,), covid-19 (Verbatim: contracted Covid starting Friday 02-Aug and tested positive), runny nose (Verbatim: mild runny nose), watering eyes (Verbatim: watery eyes) and cough (Verbatim: Cough). The outcome of the fatigue, covid-19, runny nose, watering eyes and cough were resolving.   It was unknown if the reporter considered the fatigue, covid-19, runny nose, watering eyes and cough to be related to Fluarix Tetra 2023-2024 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the fatigue, covid-19, runny nose, watering eyes and cough to be related to Fluarix Tetra 2023-2024 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-AUG-2024  The patient self-reported. He contracted Covid starting Friday 02 Aug and tested positive on Sunday 04 Aug, his symptoms are mild, runny nose, watery eyes, mild fatigue, cough.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received Menveo 2 vials presentation expired second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA938A, expiry date 31-JUL-2024) for prophylaxis.   On 06-AUG-2024, the patient received the 2nd dose of Menveo. On 06-AUG-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: received Menveo 2 vials presentation expired second dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-Aug-2024 The supervisor reported that a patient received Menveo 2 vials presentation expired second dose, which led to expired vaccine used.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Inadvertent administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 60-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number C7747, expiry date 20-JUN-2026) for prophylaxis.   On 12-AUG-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Inadvertent administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-AUG-2024 The pharmacist reported that in the facility an unplugged refrigerator over the weekend went from 60 degrees fahrenheit up to a maximum temperature of 70  degrees fahrenheit (worst scenario cumulative time was 36 hours).   A nurse administered inadvertently one Boostrix dose to a male patient, which led to incorrect storage of drug. Complete demographics and vaccine details were retrieved during this call.  No further information was given from the healthcare professional. The vaccine administration facility was the same as primary reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: A 75 years old female patient received a third dose of Shingrix.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 2KD99, expiry date 18-APR-2026) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: A 75 years old female patient received a third dose of Shingrix.). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 12-Aug-2024 The patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Shingrix - Diluent portion administered; Shingrix - Diluent portion administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a specified number of patients who received Herpes zoster (Shingrix) (batch number E3XT9, expiry date 19-JUN-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix - Diluent portion administered) and inappropriate dose of vaccine administered (Verbatim: Shingrix - Diluent portion administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 12-Aug-2024 The reporter reported that 4 patients received only the liquid portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not provide patient's details.  The reporter could not provide information about the date of administration of these doses.  During the call permission to follow up was not requested.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: a patient had received Priorix intramuscularly earlier that day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 32-year-old female patient who received MMR (Priorix) (batch number BL452, expiry date 17-DEC-2024) for prophylaxis.   On 12-AUG-2024, the patient received Priorix (intramuscular). On 12-AUG-2024, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: a patient had received Priorix intramuscularly earlier that day). The outcome of the subcutaneous injection formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Aug-2024 An intern called to inform that if a patient receives the vaccine intramuscularly, they have to repeat the vaccine series. The reporter confirmed that a patient had received Priorix intramuscularly earlier that day, which led to subcutaneous injection formulation administered by other route.
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: adult patient given the Hep B (Engerix-B) pediatric dose; adult patient given the Hep B (Engerix-B) pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 35-year-old male patient who received HBV (Engerix B pediatric) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis.   On 07-AUG-2024, the patient received Engerix B pediatric. On 07-AUG-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patient given the Hep B (Engerix-B) pediatric dose) and adult use of a child product (Verbatim: adult patient given the Hep B (Engerix-B) pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-Aug-2024 The reporter reported that we had an adult patient given the Hep B (Engerix-B) pediatric dose, which led to underdose and adult use of a child product.  The reporter did call to find out their recommendations, what they told us was to give you guys a call to see what you recommend in order for us to follow up with this. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had Covid, had the Moderna COVID vaccines; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (had Covid, had the Moderna COVID vaccines) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Kidney absent (one kidney).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had Covid, had the Moderna COVID vaccines). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (had Covid, had the Moderna COVID vaccines) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No Concomitant medications provided by the reporter.  Patient took treatment medication before. Patient had the higher dose of treatment medication because patient had one kidney. Patient took 3 tablets of treatment medication.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Lethargy; This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (Lethargy) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 203J23A) for COVID-19 immunization.     The patient's past medical history included Chronic kidney disease, GERD, Bipolar disorder, Thyroid nodule, Hypokalemia, Hyperlipidemia, Constipation, Anxiety, Anemia, Schizophrenia and Peripheral vascular disease. Concurrent medical conditions included Drug allergy (CODEINE). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), CLONAZEPAM (KLONOPIN), DONEPEZIL, DOCUSATE SODIUM, METOPROLOL TARTRATE, URSODIOL, PROBIOTICS NOS, LACTULOSE, GLYCOPYRRONIUM BROMIDE (ROBINUL), FAMOTIDINE and PARACETAMOL (TYLENOL) for an unknown indication.    On 27-Jun-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 28-Jun-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced LETHARGY (Lethargy). At the time of the report, LETHARGY (Lethargy) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter considered LETHARGY (Lethargy) to be related.    No treatment medication was reported. CT, ECG and laboratory tests results were not available.
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms or side effects reported; Patient's mother reported an AE for VARIVAX on behalf of patient. Patient's mother was registering the patient for school, and the school notified her that her son received an expired dose of VARIVAX. Patient's mother reported that the patient rec; This spontaneous report was received from a consumer's mother and refers to a male patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 17-JAN-2018, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL (lot # L034372, expiration date: 08-SEP-2017) (route of administration, anatomical location not provided) as prophylaxis. The patient's mother was aware of this when she was registering her son to the school and they informed her about the expiration date of the vaccine. No symptoms or side effects were reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; HCP stated the infant was 16 weeks old when they received the first dose of ROTATEQ /infant who was administered ROTATEQ outside of the recommendations/indications in the prescribing information.; This spontaneous report was received from a nurse and refers to a 16-weeks-old patient of unknown gender. The patient's medical history, concurrent conditions, previous drug allergies or reactions and concomitant therapies were not reported.  On 14-AUG-2024, the patient was vaccinated when the infant was 16 weeks old with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral liquid (lot #X021032, expiration date: 09-MAR-2025, which is a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ)) administered 2 mL orally for prophylaxis (strength, lot # and expiration date was not provided). The vaccine was administered outside of the recommendations/indications in the prescribing information (Product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Urticaria
Clinical narrative: Severe exacerbation of chronic urticaria that had been fully controlled; This non-serious case was reported by a consumer and described the occurrence of urticaria aggravated in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included urticaria. Concomitant products included cetirizine hydrochloride (Zyrtec), famotidine (Pepcid), montelukast and omalizumab (Xolair).   On 28-JUL-2024, the patient received Shingles vaccine. On 29-JUL-2024, 1 days after receiving Shingles vaccine, the patient experienced urticaria aggravated (Verbatim: Severe exacerbation of chronic urticaria that had been fully controlled). The outcome of the urticaria aggravated was not resolved.   The reporter considered the urticaria aggravated to be related to Shingles vaccine.     The company considered the urticaria aggravated to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-AUG-2024 The patient had chronic urticaria that has been completely controlled the last 6 years on Xolair and antihistamines.  2-3 days post vaccine the patient had a severe recurrence that was still ongoing.  The reporter was clinical trial research regular nurse and the vaccine definitely triggered this. (1st and now the last injections)  The reporter was also going to report it to the FDA.  The patient had ongoing symptoms that had not abated yet and was trying to figure out the best treatment, asked for any suggestions. The patient was going to see if could get a xolair injection earlier than every 4 weeks, would rather not do steroids if could avoid it all.   The patient was wondering if acycolvir would help, knew odd idea.
Age: 1.83
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: She injected it into my tricep, and it was also an uncleansed area; caught cellulitis; This non-serious case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 22-month-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune disorder (several autoimmune disorders).   On 06-AUG-2024, the patient received the 2nd dose of Shingrix. On 06-AUG-2024, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: She injected it into my tricep, and it was also an uncleansed area). In AUG-2024, the patient experienced cellulitis (Verbatim: caught cellulitis). The outcome of the cellulitis was not resolved and the outcome of the vaccine administered at inappropriate site was not reported.   The reporter considered the cellulitis to be related to Shingrix.     The company considered the cellulitis to be related to Shingrix.   Additional Information: GSK receipt date: 12-AUG-2024 The patient received 2nd dose of the shingrix vaccine last Tuesday, and the medical assistant who gave it put it into the wrong part of the arm, which led to vaccine administered at inappropriate site. She injected it into the triceps, and it was also an uncleansed area and caught cellulitis from it.  The reporter was reaching out to see if would need to have another dose of the vaccine due to this vaccine error. The patient had several autoimmune disorder and took immunosuppressants.
Age: 0.33
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration in a 4 month old patient; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration in a 4 month old patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-Aug-2024 The healthcare professional contacted GlaxoSmithKline through a field representative with inquiry regarding Bexsero vaccine as asking for any available information on infants given Bexsero.  The reporter stated that 4 month old patient given first dose, which led to inappropriate age at vaccine administration. The reporter need information regarding completing the series for an infant this young.
Age: 0.33
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient had been administered a dose of Havrix at 4 months of age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received HAV (Havrix) (batch number 2YZ9B, expiry date 07-DEC-2023) for prophylaxis.   On 17-MAR-2023, the patient received the 1st dose of Havrix. On 17-MAR-2023, an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient had been administered a dose of Havrix at 4 months of age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 14-AUG-2024 The nurse reported that during a review of a patient's vaccination records, it was noted that the patient had been administered a dose of Havrix at 4 months of age, no ill effects noted, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter The patient subsequently had their 12 month dose on 01st December 2023. Consented to follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Inappropriate schedule of product administration, Syncope
Clinical narrative: Patient was taken to hospital where her Heart Stopped; Fainted/ Unconscious/Light headedness/Dizziness; Patient who took Moderna Covid-19 Vaccine as a First Shot in 2020, but she took second short on 20- May-2022; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Patient was taken to hospital where her Heart Stopped) and SYNCOPE (Fainted/ Unconscious/Light headedness/Dizziness) in a 50-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1) in 2020. Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine.    On 20-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who took Moderna Covid-19 Vaccine as a First Shot in 2020, but she took second short on 20- May-2022). On 21-May-2022, the patient experienced CARDIAC ARREST (Patient was taken to hospital where her Heart Stopped) (seriousness criteria hospitalization, medically significant and life threatening) and SYNCOPE (Fainted/ Unconscious/Light headedness/Dizziness) (seriousness criteria hospitalization and medically significant). At the time of the report, CARDIAC ARREST (Patient was taken to hospital where her Heart Stopped) and SYNCOPE (Fainted/ Unconscious/Light headedness/Dizziness) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who took Moderna Covid-19 Vaccine as a First Shot in 2020, but she took second short on 20- May-2022) outcome was unknown.            No concomitant medication was reported.  It was reported that when patient was taken to hospital where her heart stopped, the Doctor's performed CPR for 45mins and her heart started to beat again. No treatment information was reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 50-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to life-threatening, hospitalization and medically significant) event of Cardiac arrest, and the unexpected and serious (due to hospitalization and medically significant) event of Syncope, which occurred 1 day after the second dose of mRNA-1273 vaccine. As reported, the patient experienced light headedness, dizziness and syncope. She was taken to Hospital where her heart stopped. The doctor's performed CPR for 45 mins and her heart started to beat again. Since then, she have been unconscious and Bedridden. No information disclosed about diagnostic tests performed. At the time of the report, the events had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she has received 5 prior Pfizer covid vaccinations and currently has tested positive for covid; she has received 5 prior Pfizer covid vaccinations and currently has tested positive for covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has received 5 prior Pfizer covid vaccinations and currently has tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment. She stated she was waiting to get the new shot, but probably should not have waited.   Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anaphylactic reaction, Drug hypersensitivity
Clinical narrative: anaphylaxis shock due to the Paxlovid and Covid vaccines; she has allergies to certain vaccines and medications including, but not limited to: Paxlovid, Prevnar 20, Iodine (imaging), certain types of antibiotics and the Covid vaccine; This is a spontaneous report received from an Other HCP. Other Case identifier(s): NUS2024US137473.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; nirmatrelvir, ritonavir (PAXLOVID), for covid-19 treatment. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis shock due to the Paxlovid and Covid vaccines"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "she has allergies to certain vaccines and medications including, but not limited to: Paxlovid, Prevnar 20, Iodine (imaging), certain types of antibiotics and the Covid vaccine". The action taken for nirmatrelvir, ritonavir was unknown.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events anaphylactic reaction, and drug hypersensitivity; and the suspect drugs BNT162B2 and NIRMATRELVIR, RITONAVIR.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Clinical course: Patient reported that she received a COVID-19 vaccine 4 years ago and still got COVID.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: PNC20
Symptoms: Drug hypersensitivity
Clinical narrative: allergies to certain vaccines and medications including, but not limited to: Prevnar 20; This is a spontaneous report received from an Other HCP.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "antibiotic allergy" (unspecified if ongoing); "Iodine (imaging) allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergies to certain vaccines and medications including, but not limited to: Prevnar 20".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 OMI XBB.1.5), as dose 1, 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) all with onset 19Aug2024, outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: Pyrexia: (unspecified date) low grade, notes: Symptoms include cough and lowgrade fever; SARS-CoV-2 test: (19Aug2024) positive.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 0.67
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: infant was inadvertently administered vquadracel instead of pentacel with no reported adverse event; misuse as per local labelling due to the administration of the vaccine to an underage patient per the label with no reported adverse event; Initial information received on 16-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 months old male patient who was inadvertently administered Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (VERO) Vaccine [Quadracel (Vero)] instead of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [PENTACEL (VERO)] with no reported adverse event and misuse as per local labelling due to the administration of the vaccine to an underage patient per the label 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 20V (CRM197) (Prevnar 20) for Prophylactic vaccination; and Rotavirus Vaccine for Prophylactic vaccination.  On 16-Aug-2024, the patient received a dose of 0.5 ml of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/IPV (VERO) Vaccine (Suspension for injection) (lot U7931AB, Expiry date: 09-Nov-2025, strength was unknown) via intramuscular route in Left Lateral Vasteralis  and dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Powder and suspension for suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for all Prophylactic vaccination (Immunization) and was inadvertently administered vquadracel instead of pentacel with no reported adverse event (wrong product administered) and misuse as per local labelling due to the administration of the vaccine to an underage patient per the label with no reported adverse event (product administered to patient of inappropriate age) (latency : same day). The information regarding on batch number and expiry date at time of event onset was requested.   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: 1.58
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: alternate diluents with the ACTHIB due to the clinic having a patient getting the booster of ACTHIB and the powder was not mixed with the diluent supplied in the package but with sterile water instead with no reported adverse event; the use of alternate diluents with the ACTHIB due to the clinic having a patient getting the booster of ACTHIB with no reported adverse event; Initial information received on 16-Aug-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 19 months old female patient who had alternate diluents with the ACT-HIB due to the clinic having a patient getting the booster of HIB (PRP/T) Vaccine [ACT-HIB] and the powder was not mixed with the diluent supplied in the package but with sterile water instead 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 07-Aug-2024, the patient received a Booster dose of  0.5 ml of (Frequency: once) of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot UK005AA, Expiry date: 31-Dec-2024, strength was unknown) via unknown route in unknown administration site for Immunization and alternate diluents with the acthib due to the clinic having a patient getting the booster of acthib and the powder was not mixed with the diluent supplied in the package but with sterile water instead with no reported adverse event (product preparation error) and (poor quality 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 and Module of the 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: 4.0
Sex: M
Vaccine: DTPPVHBHPB, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse reaction. Kinrix was ordered and staff member gave Vaxelis. Patient doing well and no concerns.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site bruising, Injection site reaction
Clinical narrative: Day after vaccine woke up with very bad headache, nausea, and generally feeling very bad.  Not able to complete the entire day at school.  The headache, nausea and general tiredness lasted 24 hours - with symptoms decreasing the next 48-72 hours.   Local reaction at injection site much worse than previous vaccines - swelling lasting 3-4 days and deep purple bruising.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Local reaction, Loss of personal independence in daily activities, Nausea
Clinical narrative: Day after vaccine woke up with very bad headache, nausea, and generally feeling very bad.  Not able to complete the entire day at school.  The headache, nausea and general tiredness lasted 24 hours - with symptoms decreasing the next 48-72 hours.   Local reaction at injection site much worse than previous vaccines - swelling lasting 3-4 days and deep purple bruising.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: patient is less than 12 years old and received 0.5mL of vaccine instead of prescribed 0.25mL
Age: 9.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was given a vaccine recommended for ages 18+ when they were 9 at the time of vaccination. The pharmacy tried to contact the patient's caregiver at the error's discovery, however they were unable to be reached. 2 voicemails were left.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site bruising, Injection site swelling
Clinical narrative: Day after vaccine woke up with very bad headache, nausea, and generally feeling very bad.  Not able to complete the entire day at school.  The headache, nausea and general tiredness lasted 24 hours - with symptoms decreasing the next 48-72 hours.   Local reaction at injection site much worse than previous vaccines - swelling lasting 3-4 days and deep purple bruising.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Loss of personal independence in daily activities, Nausea
Clinical narrative: Day after vaccine woke up with very bad headache, nausea, and generally feeling very bad.  Not able to complete the entire day at school.  The headache, nausea and general tiredness lasted 24 hours - with symptoms decreasing the next 48-72 hours.   Local reaction at injection site much worse than previous vaccines - swelling lasting 3-4 days and deep purple bruising.
Age: 55.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Erythema, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: hot, red swollen are on arm from just below the shoulder to below the elbow with a red inflamed area at injection site relieved by benadryl
Age: 55.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: hot, red swollen are on arm from just below the shoulder to below the elbow with a red inflamed area at injection site relieved by benadryl
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: C-reactive protein, Computerised tomogram head normal, Electroencephalogram, Full blood count, Laboratory test normal
Clinical narrative: Child developed generalized seizures approximately 11 hr after having his vaccines. Was well appearing with normal exam other than hemangioma at visit that morning. Taken to local ER, received multiple medications for seizure control, had neg CT and was flown to hospital.  No fever. Infection work up negative in the ER.  Normal labs.  No hx of trauma.  Child still in hospital, had EEG, MRI tomorrow and possible dc home if doing well.  PLEASE NOTE THAT THE VACCINE WAS ACTUALLY PREVNAR 15 HOWEVER THAT VACCINE WAS NOT ABLE T BE SELECTED SO I SELECTED PREVNAR 13 TO BE ABLE TO COMPLETE THIS FORM. THAT IS A GLITCH THAT SHOULD BE FIXED.  THE LOT NUMBER IS CORRECT.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Metabolic function test, Seizure, Viral test
Clinical narrative: Child developed generalized seizures approximately 11 hr after having his vaccines. Was well appearing with normal exam other than hemangioma at visit that morning. Taken to local ER, received multiple medications for seizure control, had neg CT and was flown to hospital.  No fever. Infection work up negative in the ER.  Normal labs.  No hx of trauma.  Child still in hospital, had EEG, MRI tomorrow and possible dc home if doing well.  PLEASE NOTE THAT THE VACCINE WAS ACTUALLY PREVNAR 15 HOWEVER THAT VACCINE WAS NOT ABLE T BE SELECTED SO I SELECTED PREVNAR 13 TO BE ABLE TO COMPLETE THIS FORM. THAT IS A GLITCH THAT SHOULD BE FIXED.  THE LOT NUMBER IS CORRECT.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blood creatine phosphokinase, Computerised tomogram, Differential white blood cell count, Full blood count, Gait inability
Clinical narrative: He got the vaccines on 8/15/24 and on 8/16/24 he started vomiting and on 8/17/24 he could not walk.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Lumbar puncture, Magnetic resonance imaging, Metabolic function test, Red blood cell sedimentation rate, Vomiting
Clinical narrative: He got the vaccines on 8/15/24 and on 8/16/24 he started vomiting and on 8/17/24 he could not walk.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient received the doses at age 19 and should have started it at age 20 manufacturer guidelines are age 20 not 19
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient had a bruise on her right arm about 4 inches below where she received the RSV vaccination. No other symptoms other than slight pain at the bruised area.
Sex: U
Vaccine: COVID19
Symptoms: Acute macular neuroretinopathy, Angiogram, Blood test, Computerised tomogram, Lumbar puncture
Clinical narrative: Acute Macular Neuroretinopathy,
Sex: U
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Magnetic resonance imaging neck, Magnetic resonance imaging spinal, Optical coherence tomography
Clinical narrative: Acute Macular Neuroretinopathy,
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Accidental exposure to product, Blood test, Injury associated with device
Clinical narrative: Adverse event is a needle stick that the immunizer received as a result of administering the associated vaccine.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with booster
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: hospitalized with covid; fully vaccinated with booster
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient received 2 doses of Flucelvax Trival 2024-2025. 1st dose on 07/30/2024, 2nd Dose on 08/20/2024.  Patient stated that her arm was sore and slightly swollen but believed that was normal.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Red circle at administration site