chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A 52-year-old patient received BNT162b2 (BNT162B2), 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: THROMBOSIS (death, medically significant), 6 days after the suspect product(s) administration, outcome "fatal", described as "blood clot". They lost a family member to a blood clot 6 days after the first covid vaccine. The patient date of death was unknown. Reported cause of death: "blood clot". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: blood clot
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 12/15/22 presents to ED for "shortness of breath". PMHx of "CLL".
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 15:30 as dose 5 (booster), single (Lot number: GJ3277) at the age of 69 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 04May2021 at 14:30 as dose 1, single (Lot number: EWO173), in right arm, on 04Jun2021 at 14:30 as dose 2, single (Lot number: EWO186), in right arm, on 04Dec2021 at 15:00 as dose 3 (booster), single (Lot number: FH8028), in right arm and on 04May2022 at 15:30 as dose 4 (booster), single (Lot number: FJ4991), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Heart" (unspecified if ongoing); "Some known allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Dec2022, outcome "unknown", COVID-19 (medically significant) with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given incorrect Covid vaccine for age group. pt is 6 months old. pt received Moderna Covid vaccine for ages 6yrs-11yrs and dose amount of .5ML ( lot number 018C22A) . Pt should have received Moderna Covid vaccine for ages 6 months-5yrs ( lot number AR9236B) , dose amount .25ML.  Type Administration error/deviation I Product and dosage Higher-than-authorized dose administered (e.g., incorrect dose volume, incorrect product resulting in higher-than-authorized dose) Do not repeat dose.?? ?If the administration error resulted in a higher-than-authorized vaccine dose, in general a subsequent dose may still be administered at the recommended interval. However, if local or systemic side effects following vaccination are clinically concerning (outside of the expected side effect profile), lead to serious adverse reactions, or are ongoing at the time of the subsequent dose, this dose might be delayed, but this decision should be assessed on a case-by-case basis.
Age: 0.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product confusion, Wrong product administered
Clinical narrative: No additional AE details or PQC; A 6 month old was inadvertently administered GARDASIL 9 instead of Prevnar 13; The HCP who administered the vaccine had confused the 2 products for unspecified reasons; This spontaneous report was received from a health care professional (HCP) referring to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-DEC-2022, the patient was inadvertently administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (lot number: 1780876, which was determined to be valid with expiration date: 09-NOV-2023;  strength, anatomical site of vaccination and route of administration were not provided) instead of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (strength, formulation, dose, frequency, lot number, and expiration date were not provided) (wrong product administered). Both suspect vaccines indicated for prophylaxis. It was reported that the HCP who administered the vaccine had confused the two products for unspecified reasons (product confusion). No additional adverse event (AE) details (no adverse event).
Age: 31.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives started back of neck and arms 3 hrs post vaccination. Next day spread over body. Itching. No resp, or GI sx. No evidence of IgE/anaphylaxis. Resolved in 2-3 days with Claritin. Went to urgent care the following day.   Symptoms: URTICARIA, UNSPECIFIED(L509).
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Massive sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be possibly related to Flu vaccine.     Linked case(s) involving the same patient: US2023AMR001684.  Additional Information: GSK receipt date: 05-JAN-2023 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received the flu vaccine twice in her life and stated that was not sick from that was a massive sore arm. The patient stated that she wanted to give his/her 16 month but not planned on getting it herself as she already caught a very nasty this year and felt 5 time worsened than the covid. Additional supportive information: For tolerance to the 2nd dose refer case US2023AMR001684.; Sender's Comments:  US-GSK-US2023AMR001684:Same reporter
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Massive sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of pain in extremity (On an unknown date 1st dose received for tolerance of 1st dose refer case US2023AMR001645).   On an unknown date, the patient received the 2nd dose of Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. Rechallenge with Flu vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be possibly related to Flu vaccine.     Linked case(s) involving the same patient:  US2023AMR001645   Additional Information: GSK receipt date: 05-JAN-2023 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received the flu vaccine twice in her life and stated that was not sick from that was a massive sore arm. The patient stated that she wanted to give his/her 16 month but not planned on getting it herself as she already caught a very nasty this year and felt 5 time worsened than the covid; Sender's Comments:  US-GSK-US2023AMR001645:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sickest year ever had; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be possibly related to Influenza vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment:This case was received by the consumer via interactive digital media. The reporter wanted to know if other guys received shot previously. The reporter reported that she did not care to debate any mom shammers on here, so don't bother to comment anything negative as a reply. The patient asked if you guys have gotten it before because she urge them to get it for yourself a few weeks before baby girl. The reporter stated that if it dose make you sick then you don't want the entire family down at the same time. The patient had only gotten the flu shot once and it was the sickest year she had ever.
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Malaise, Pain in extremity
Clinical narrative: Didn't make me feel good; Arm sore; Didn't get much sleep/sleep loss; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in 2022).   On 6th January 2023, the patient received the 2nd dose of Shingles vaccine. In January 2023, less than a day after receiving Shingles vaccine, the patient experienced feeling unwell, pain in arm and sleep loss. On an unknown date, the outcome of the feeling unwell, pain in arm and sleep loss were unknown.   It was unknown if the reporter considered the feeling unwell, pain in arm and sleep loss to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she never had a shingles. The patient stated that he/she received his/her last Shingles shot on Friday. The patient reported that last shot did not made him/her feel good for several after going to bed on that night. The patient experienced arm sore, did not get much sleep and he/she was sure that his/her sleep loss on last night. The patient reported that from stories he/she heard, he/she sure did not want it. Additional supportive information: Follow-up would not possible as no contact details were available.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 47 YO was administered Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female patient who received Herpes zoster (Shingrix) (batch number 23E5G, expiry date 11th February 2024) for prophylaxis.   On 20th September 2022, the patient received the 1st dose of Shingrix. On 20th September 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 03-JAN-2022 Reporter's Comments: The pharmacist enquired, on how to proceed and any effectiveness data available for the first dose until patient turned 50 years and any under 50 years guidance. The registered pharmacist (RPH) stated they realized the patient was not immunocompromised and had no underlying conditions and the patient really should not had gotten the Shingrix dose at this age. The RPH mentioned they follow disease control guidelines and based on disease control protocol technically they could not administer the second dose until the patient is 50 years of age. The pharmacist confirmed second dose had not been administered. The reporter did not consent to follow up. Additional Supportive Information: The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 77.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 77-year-old male patient who received HBV (Engerix B adult) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd January 2023, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 3rd January 2023, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 05 JAN 2023 Reporters comment: The nurse practitioner reported that the patient received an adult dose of Engerix B on 3rd January 2023 and the dose had expired on 2nd January 2023. The reporter wanted to know should re vaccinate. The Vaccine Administration Facility was the same as Primary Reporter. Additional supportive information. As patient administered expired vaccine which led to expired vaccine used. Reporter did not consent to follow up as no contact details were available.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong technique in product usage process
Clinical narrative: Vx administered 2 days after reconstitution/ inadvertently administered to a patient this morning on 1/5/23; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in drug usage process in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 23E5G, expiry date 11th February 2024) for prophylaxis.   Previously administered products included Shingrix (first dose was received on an 23 August 2022).   On 5th January 2023, the patient received the 2nd dose of Shingrix. On 5th January 2023, unknown after receiving Shingrix, the patient experienced wrong technique in drug usage process. On an unknown date, the outcome of the wrong technique in drug usage process was unknown.   Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's comments: The pharmacist had called up to inquired about any guidance.  The pharmacist had reported that, shingrix was reconstituted two days ago before the reporting and then was inadvertently administered to a patient this morning, at the time of reporting as the patient second dose. The reporter did not consent to follow-up. Additional supportive information: The patient had received the Shingrix vaccine that was reconstituted two days ago on Monday then inadvertently administered to a patient this morning, which had led to wrong technique in drug usage process.
Age: 63.0
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose was administered to adult patient; pediatric dose was administered to adult patient; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 63-year-old patient who received HAV (Havrix pediatric) (batch number Y67YJ, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th January 2023, the patient received the 1st dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 5th January 2023, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose 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: 05-JAN-2023 Reporter's comment: A pharmacist had called up to informed that, a pediatric dose of Havrix was administered to an adult patient. The date of administration was not specified by the reporter. When looking for the lot number that the HCP gave, it was not found in the system. The reporter had consent to follow-up. Additional supportive information: The adult patient received the Havrix pediatric dose, which had led to adult use of a child product and underdose.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstitution with unknown diluent; did not use the supplied CYW-135 liquid conjugate portion to reconstitute the dose; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA721A, expiry date 30th September 2023) for prophylaxis.   Previously administered products included Menveo (received first dose on 16th November 2018).   On 3rd January 2023, the patient received the 2nd dose of Menveo. On 3rd January 2023, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 5-Jan-2023 Reporter's comment: The nurse reported that a colleague administered a dose of Menveo to a patient, however the nurse did not use the supplied CYW-135 liquid conjugate portion to reconstitute the dose.   The nurse that administered the vaccine was not in the office on the day of reporting, so it was unknown what diluent was used for reconstitution.   At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. Additional supportive information: The patient received a dose of Menveo with unknown diluent, however the nurse did not use the supplied CYW-135 liquid conjugate portion to reconstitute the dose, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Pediarix was given instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number TS425, expiry date 21st October 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: 5-Jan-2023 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via mail. Additional supportive information: The patient received a dose of Pediarix instead of Infanrix, which led to wrong vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient never received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd May 2018 with batch number 5NY3B).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: The pharmacist enquired if they should repeat the dose or would the patient had to start over since it had been over 6 months. The registered pharmacist (RPH) reported that, the patient never received the second dose. The registered pharmacist mentioned patient was coming to get the second dose. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose
Clinical narrative: while administering shignrix to a patient half way through the patient moved and only received 3 quarters of half of the dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17th February 2024) for prophylaxis.   On 5th January 2023, the patient received Shingrix. On 5th January 2023, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: The pharmacist reported that, while administering Shignrix to a patient half way through the patient moved and only received 3 quarters of half of the dose and the rest splashed on pharmacist face and eyes. The reporter consented to follow up. Additional Supportive Information: The patient did not receive recommended dose volume of the Shingrix, which led to accidental underdose. This case had been linked with US2023001210, reported by the same reporter.; Sender's Comments:  US-GSK-US2023001210:same reporter - pharmacist case
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Exposure via skin contact, Occupational exposure to product
Clinical narrative: while administering shignrix to a patient, splashed on pharmacist face and eyes; splashed on pharmacist face; splashed on pharmacist eyes.; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while administering product in a female patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17th February 2024) for prophylaxis.   On 5th January 2023, the patient did not receive Shingrix. On 5th January 2023, unknown after receiving Shingrix, the patient experienced occupational exposure while administering product, exposure via skin contact and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while administering product, exposure via skin contact and exposure via eye contact were unknown.  Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: The reporter was also the patient. The pharmacist reported that, while administering Shignrix to a patient half way through the patient moved and only received 3 quarters of half of the dose and the rest splashed on (her) pharmacist face and eyes. The reporter consented to follow up. Additional Supportive Information: The pharmacist got exposed to Shignrix while administering to the patient, which led to occupational exposure while administering product, exposure via skin contact and exposure via eye. This case had been linked with US2023001206, reported by the same reporter.; Sender's Comments:  US-GSK-US2023001206:same reporter - patient´s case
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: there may have been patients who were administered Shingrix subcutaneously; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: The healthcare professional (HCP) reported that there was some confusion in their office of whether Shingrix should be administered subcutaneously or intramuscular. The reporter thought that, there might have been patients who were administered Shingrix subcutaneously but was not sure at this time until a chart review had been completed.  The reporter consented to follow up. Additional Supportive Information: The patients received Shingrix subcutaneously, which led to intramuscular formulation administered by other route.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Tooth infection
Clinical narrative: Two infected teeth; 1st dose in Aug2021, 2nd not received; This case was reported by a nurse via call center representative and described the occurrence of tooth infection in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, between 1 and 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tooth infection and incomplete course of vaccination. On an unknown date, the outcome of the tooth infection was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the tooth infection to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: The reporter was wife of patient called stating her husband (patient) was at the dentist on the day of reporting and had two infected teeth and that they could had been infected for a month, but she did not know.  The reporter was stated that her husband was forgetful.  Nurse did not wish to provide any additional information, including her contact information.  The reason she called was asked if her husband could receive his 2nd dose of Shingrix tomorrow given his infected teeth. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Multiple sclerosis, Staphylococcal infection, Urinary tract infection
Clinical narrative: MS; UTI; Staph infection; This case was reported by a nurse via sales rep and described the occurrence of multiple sclerosis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced multiple sclerosis (serious criteria GSK medically significant), urinary tract infection and staphylococcal infection. On an unknown date, the outcome of the multiple sclerosis, urinary tract infection and staphylococcal infection were unknown.   It was unknown if the reporter considered the multiple sclerosis, urinary tract infection and staphylococcal infection to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comment: The reporter was a GSK field representation reporting a Shingrix AE (adverse event) that was given to him by a nurse at one of his accounts.  The reporter had limited information.  The reporter had reported all the information provided. The nurse reported that a patient received a dose of Shingrix (not confirmed if 1st or 2nd dose) and shortly after receiving dose got a staph infection, UTI, and was diagnosed with MS (Multiple sclerosis).  The reporter consent to follow up.
Age: 69.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 69-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA641A, expiry date 31st October 2022) for prophylaxis.   On 28th November 2022, the patient received Menveo. On 28th November 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 6-Jan-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Age: 42.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix Administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th January 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 9-Jan-2023 Reporter's comment: Pharmacist administered Havrix to a patient after the expiration date. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: FLUX
Symptoms: Seizure
Clinical narrative: Seizures; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, several days after receiving Flu vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   The reporter considered the seizure to be possibly related to Flu vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: The case was received from the patient's parent via interactive digital media. The patient had the flu shot and had seizures days after receiving it. Did the reporter think that the event might have been related to the Product/Device. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation
Clinical narrative: COVID-19; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 49-year-old female. The patient's height, and weight were not reported. The patient's past medical history included: penicillin allergy, and feminine wash allergy, and concurrent conditions included: hypothyroidism. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 207A21A expiry: unknown) dose was not reported, 1 total administered at left arm on 11-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 48 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received second dose of non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, and route of admin were not reported, batch number: O12F21A, expiry: unknown) dose and frequency were not reported administered at right arm on 23-OCT-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with Moderna covid-19 vaccine (Dose number in series 2). The patient received third dose of non-company suspect vaccine included: Pfizer Biontech covid-19 vaccine (tozinameran) (Dose number in series 3) (form of admin and route of admin were not reported, batch number: GH9694, expiry: unknown) dose and frequency were not reported administered at right arm on 11-SEP-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). Concomitant medications included Zyrtec (cetirizine hydrochloride), Vitamin D3 (colecalciferol), Dayquil (dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride), and levothyroxine. On an unspecified date, the patient experienced covid-19 (Dose number in series 3). The patient was treated with non-company suspect drug Paxlovid (form of admin and route of admin was not reported, batch number: 6c7458 and expiry date was not reported) dose and frequency were not reported for covid-19 treatment from 22-DEC-2022 to 26-DEC-2022.  On 31-DEC-2022 09:00, the patient experienced Paxlovid rebound (covid-19 rebound) 5 days after the completion of Paxlovid treatment (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, tozinameran and paxlovid was not applicable. The patient was recovering from covid-19, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP reported VARIVAX was administered after a temperature excursion to a patient.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, historical drugs, known allergies, concurrent conditions and concomitant therapies were not reported.  On 04-AUG-2022, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # U015847 with expiration date of 19-MAY-2023, which had been verified to be a valid lot # for varicella virus vaccine live (Oka/Merck) (VARIVAX), administered once for prophylaxis (strength, dose, and route of administration were not provided) that experienced a temperature excursion of 8.42 Fahrenheit grades (F) for a time frame of 1 hour, 2 minutes. No previous temperature excursion reported, if a data logger was involved was not reported (product storage error). No further information provided and no additional adverse event (AE) (no adverse event) reported.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years).    No concomitant medication information was reported. The nurse reported that they had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years on 09Dec2022. They were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation. These were the patient's 1st doses. No adverse events had been reported by the patients. No treatment medication information was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Bladder discomfort, Blood test, Computerised tomogram head, Electromyogram
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in 2 little toes), ABDOMINAL DISCOMFORT (Now is starting to affect her bowels and bladder) and BLADDER DISCOMFORT (Now is starting to affect her bowels and bladder) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F27A, 039B21A and 007B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness in 2 little toes). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Now is starting to affect her bowels and bladder) and BLADDER DISCOMFORT (Now is starting to affect her bowels and bladder). At the time of the report, HYPOAESTHESIA (Numbness in 2 little toes) had not resolved and ABDOMINAL DISCOMFORT (Now is starting to affect her bowels and bladder) and BLADDER DISCOMFORT (Now is starting to affect her bowels and bladder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: no diagnosis. On an unknown date, Computerised tomogram head: no diagnosis. On an unknown date, Electromyogram: no diagnosis. On an unknown date, Lumbar puncture: no diagnosis. On an unknown date, Magnetic resonance imaging: no diagnosis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The caller was a caregiver call on behalf of her sister-in-law, reporting that 2 weeks after receiving her 1st dose given on 22-Mar-2021, she experienced numbness in 2 little toes. From then to now, it continues to rise. From her femur bone down, she had no feeling. If she lays in bed and touches one leg, she could not tell where the other leg was. She was careful when walking, could not drive and could not feel her legs. It never affected her organs but now was starting to affect her bowels and bladder. The caller waited so long to call because she was under her doctor's care and were not placing blame on the vaccine because did not know if it was the cause. The neurologist had ruled out Guillaume Barre and told her that he did not know what else to do. It was reported that they were afraid and worried that her lungs would be affected, and she would not be able to breathe. Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in 2 little toes), ABDOMINAL DISCOMFORT (Now is starting to affect her bowels and bladder) and BLADDER DISCOMFORT (Now is starting to affect her bowels and bladder) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F27A, 039B21A and 007B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness in 2 little toes). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Now is starting to affect her bowels and bladder) and BLADDER DISCOMFORT (Now is starting to affect her bowels and bladder). At the time of the report, HYPOAESTHESIA (Numbness in 2 little toes) had not resolved and ABDOMINAL DISCOMFORT (Now is starting to affect her bowels and bladder) and BLADDER DISCOMFORT (Now is starting to affect her bowels and bladder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: no diagnosis. On an unknown date, Computerised tomogram head: no diagnosis. On an unknown date, Electromyogram: no diagnosis. On an unknown date, Lumbar puncture: no diagnosis. On an unknown date, Magnetic resonance imaging: no diagnosis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The caller was a caregiver call on behalf of her sister-in-law, reporting that 2 weeks after receiving her 1st dose given on 22-Mar-2021, she experienced numbness in 2 little toes. From then to now, it continues to rise. From her femur bone down, she had no feeling. If she lays in bed and touches one leg, she could not tell where the other leg was. She was careful when walking, could not drive and could not feel her legs. It never affected her organs but now was starting to affect her bowels and bladder. The caller waited so long to call because she was under her doctor's care and were not placing blame on the vaccine because did not know if it was the cause. The neurologist had ruled out Guillaume Barre and told her that he did not know what else to do. It was reported that they were afraid and worried that her lungs would be affected, and she would not be able to breathe. Treatment information was not provided.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Covid-19: August 2019 & January 2023.  The patient's past medical history included COVID-19 in August 2019 and COVID-19 (Jan-2023).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. It was reported that patient had covid-19 in Aug 2019. April and May 2020 got vaccinated. In Jan-2023 caught covid-19 for 2nd time. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2023: Live follow up contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a person received a bivalent booster dose instead of the second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (a person received a bivalent booster dose instead of the second dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (a person received a bivalent booster dose instead of the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (a person received a bivalent booster dose instead of the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient received any other vaccines in the four weeks prior to covid-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that caller confirms that did not take place for them but that they have seen it at other stores.  Treatment information was not provided.   Reporter did not allow further contact