chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; HCP calling to report an AE regarding the PROQUAD vaccine. HCP reported that a 31 year old patient was inadvertently administered a dose of the PROQUAD vaccine. HCP provided limited pertinent information and demographic data. HCP had no further clari; This spontaneous report was received from pharmacist and refers to a 31-year-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-JUL-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #X025092, expiration date: 16-APR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine was administered to a patient of inapproved age (Product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects / No additional AE; PNEUMOVAX 23 was inadvertently administered after experiencing a temperature excursion; This spontaneous report was received from Other Health Professional and refers to a 60-year-old patient of unspecified gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 06-NOV-2023, the patient was inadvertently vaccinated with an improperly stored dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (involved lot # was X018273, expiration date: 07-OCT-2024); administered as prophylaxis (strength, and route of administration were not provided). Temperature excursion was 30.4 Fahrenheit degrees (F) and time frame was 264 hours. There was no previous temperature excursion nor report of adverse effect or product quality complaint involved.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainted after receiving the dose; This spontaneous report was received from a field based employees (FBE) and refers to a 12-year-old female patient. The patient's medical history, oncurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, exact dose, dose#, lot #, expiry date, anatomical location and route of administration were not provided) for prophylaxis.  On an unknown date (reported as: after receiving the dose), she fainted. At the reporting time, the outcome of the event was unknown.   The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   Upon internal review, the event of fainted was determined to be medically significant.  This is one of two reports from the same reporter (the event for a twin sister was captured in MARRS# 2408USA001072).  Lot # is being requested and will be submitted if received.; Sender's Comments:  US-009507513-2408USA001072:MSD
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX y002062   1/9/2026 Temperature: -12.13C Time frame: 1; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 02-AUG-2024 the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # Y002062 and expiration date 09-JAN-2026 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The temperature excursion lasted for 19 minutes in temperature of -12.13 Celsius degrees (product storage error). No additional adverse events were reported (no adverse event).
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Adult given pediatric formulation; Adult given pediatric formulation.; This non-serious case was reported by a nurse and described the occurrence of accidental underdose in a 29-year-old male patient who received HAV (Havrix 720) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   On 31-JUL-2024, the patient received Havrix 720 (intramuscular). On 31-JUL-2024, an unknown time after receiving Havrix 720, the patient experienced accidental underdose (Verbatim: Adult given pediatric formulation) and adult use of a child product (Verbatim: Adult given pediatric formulation.). The outcome of the accidental underdose was not reported and the outcome of the adult use of a child product was resolved.   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: 01-AUG-2024 The registered nurse (RN) was not dispensing the prefilled syringe (PFS) from the box that was labelled pediatric or adult formulation. The registered nurse assumed the prefilled syringe (PFS) would state adult or pediatric on the label as does the Hepatitis B recombivax vaccine. Suggest labelling adult or pediatric on the prefilled syringe. The reporter missed the dose and the colored ring on the prefilled syringe, adult given pediatric formulation. The registered nurse expected the prefilled syringe to say adult on the label. The nurse was administered pediatric doses of Havrix 720 vaccine to a adult patient, which led to accidental underdose and adult use of a child product.
Sex: F
Vaccine: COVID19, RSV
Symptoms: Rash
Clinical narrative: Rash on mid abdomen and back; This non-serious case was reported by a nurse via sales rep and described the occurrence of rash in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number T5232, expiry date 18-AUG-2025) for prophylaxis.   Co-suspect products included Tozinameran (Comirnaty) (batch number HJ7225, expiry date 30-MAY-2024) for prophylaxis.   On 25-JAN-2024, the patient received the 1st dose of Arexvy (left deltoid). On an unknown date, the patient received Comirnaty (intramuscular, right deltoid). On 28-JAN-2024, 3 days after receiving Arexvy, the patient experienced rash (Verbatim: Rash on mid abdomen and back). The outcome of the rash was resolved.   It was unknown if the reporter considered the rash to be related to Arexvy.     It was unknown if the company considered the rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-AUG-2024 The nurse reported that, the patient received 1st dose of Arexvy. The patient was given with Comirnaty 2023-24 30mcg/0.3 ml intramuscular in right deltoid. The patient and had rash on mid abdomen and back. It was unknown if the reporter considered the rash to be related to Comirnaty.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site warmth, Rash
Clinical narrative: Rash; warm at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (For tolerance of 1st dose refer case US2024094279.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site warmth (Verbatim: warm at injection site) and rash (Verbatim: Rash). The patient was treated with triamcinolone acetonide (Triamcinolone). The outcome of the injection site warmth was resolved (duration 3 days) and the outcome of the rash was not resolved.   It was unknown if the reporter considered the injection site warmth and rash to be related to Shingrix.     It was unknown if the company considered the injection site warmth and rash to be related to Shingrix.   Linked case(s) involving the same patient:  US2024094279   Additional Information: GSK Receipt Date: 26-JUL-2024 Patient received second dose of suspect vaccine in October of 2023. Reported immediately after second dose left arm was warm at injection site for 3 day and then resolved. Patient reported in May of 2024 a rash appeared on her left shoulder, chest, and rib cage that has not resolved. Patient went to the Dermatologist who was currently treating the rash with Triamcinolone 0.25% cream. Patient reported she has no spleen since 2008 due to complications during a colonoscopy. Reporter did not have exact dates of vaccinations or lot numbers for dose 1 and 2 of vaccine series. For tolerance of 1st dose refer case US2024094279.; Sender's Comments:  US-GSK-US2024094279:Dose 1
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received the second dose of Shingrix latter than 6 months apart.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (on an unknown date received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: a patient received the second dose of Shingrix latter than 6 months apart.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 23-JUL-2024  An HCP reported that a patient received the second dose of Shingrix latter than 6 months apart. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Muscular weakness, Speech disorder, Vertigo, Vision blurred
Clinical narrative: self-diagnosed this as Guillain-Barre Syndrome; began experiencing vertigo; losing his balance; lower legs and extremities are weak; his vision is blurred; his speech is impaired; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In FEB-2024, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix and between 4 and 5 months after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: self-diagnosed this as Guillain-Barre Syndrome) (serious criteria GSK medically significant), vertigo (Verbatim: began experiencing vertigo), loss of balance (Verbatim: losing his balance), weakness in extremity (Verbatim: lower legs and extremities are weak), blurred vision (Verbatim: his vision is blurred) and speech disorder (Verbatim: his speech is impaired). The outcome of the guillain barre syndrome was not reported and the outcome of the vertigo, loss of balance, weakness in extremity, blurred vision and speech disorder were unknown.   It was unknown if the reporter considered the guillain barre syndrome, vertigo, loss of balance, weakness in extremity, blurred vision and speech disorder to be related to Shingrix and Shingrix.     The company considered the guillain barre syndrome to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the vertigo, loss of balance, weakness in extremity, blurred vision and speech disorder to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 23-JUL-2024 The patient self-reported this case for himself. The patient received his 1st Shingrix dose in February 2024 and the 2nd dose in late April or early May 2024.  The patient stated that about 3 weeks ago he began experiencing vertigo and losing his balance.  The patient reported that his lower legs and extremities were weak, his vision was blurred and his speech was impaired.  The patient had self-diagnosed this as Guillain-Barre Syndrome after seeing a Shingrix television advertisement that mentioned it.  The patient had not seen a doctor.  The patient was suggested to see a doctor for a diagnosis and potential treatment as soon as possible.  The reporter consented to follow up.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: According to reporter, an 11-year-old patient received a dose of Kinrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   On 23-JUL-2024, the patient received Kinrix. On 23-JUL-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: According to reporter, an 11-year-old patient received a dose of Kinrix.). 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: 23-JUL-2024 The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: accidentally administered a dose of Priorix on July 23th 2024 intramuscularly instead of subcutaneously; Priorix on July 23th 2024 intramuscularly instead of subcutaneously to a 29 year old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 29-year-old female patient who received MMR (Priorix) (batch number X3M3D, expiry date 01-APR-2025) for prophylaxis.   Previously administered products included MMR (received a prior measles, mumps, and rubella vaccine back on November 7th 1996 but brand, ).   On 23-JUL-2024, the patient received the 2nd dose of Priorix. On 23-JUL-2024, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: accidentally administered a dose of Priorix on July 23th 2024 intramuscularly instead of subcutaneously) and inappropriate age at vaccine administration (Verbatim: Priorix on July 23th 2024 intramuscularly instead of subcutaneously to a 29 year old patient). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration 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: 23-JUL-2024 Nurse stated she accidentally administered a dose of Priorix on intramuscularly instead of subcutaneously to a 29 year old patient, which led to incorrect route of vaccine administered and inappropriate age at vaccine administration. Consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: RN reports patient received their first dose of Engerix-B on 29-JAN-2024 and didn't come back for 2nd one on time; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 27-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (1st dose received On 29-JAN-2024 with batch number FR334 and expiry date 24-AUG-2024).   On an unknown date, the patient did not receive the 2nd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced incomplete course of vaccination (Verbatim: RN reports patient received their first dose of Engerix-B on 29-JAN-2024 and didn't come back for 2nd one on time). The outcome of the incomplete course of vaccination was not reported.   Additional Information: GSK Receipt Date; 24-JUL-2024 The register nurse reported that a patient had received their first dose of Engerix B on 29th January 2024 and did not come back for 2nd one on time. Till the time of reporting patient did not received the second dose of Engerix B which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2nd December 2020, batch B3TL7, expiry date expiry 30-SEP-2022 ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix - Late second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-JUL-2024 The pharmacist mentioned that a patient received the first dose of Shingrix.  The HCP asked if they could proceed with the second dose or if the patient needed to re-start the series. Till the time of reporting the patient did not receive 2nd dose which led to incomplete course of vaccination. During the call permission to follow up was not requested.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: An expired dose of Hiberix (expired on 7/12/2024) was administered to a 4 months old patient; 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 4-month-old female patient who received Hib (Hiberix) (batch number 7E2LD, expiry date 12-JUL-2024) for prophylaxis.   In JUL-2024, the patient received Hiberix. In JUL-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: An expired dose of Hiberix (expired on 7/12/2024) was administered to a 4 months old patient). The outcome of the expired vaccine used was unknown.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult patient (unknown age) got a pediatric dose of Engerix-B; Underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Hepatitis B (1st dose) and Hepatitis B (2nd dose).   On 24-JUL-2024, the patient received the 3rd dose of Engerix B. On 24-JUL-2024, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: adult patient (unknown age) got a pediatric dose of Engerix-B) and underdose (Verbatim: Underdose). 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: 24-JUL-2024 The pharmacist explained that in ambulatory clinic an adult patient (unknown age) got a pediatric dose of Engerix-B, which lead underdose and adult use of a child product. The reporter mentioned it was the third dose of the series for Hepatitis B, and he thought that prior doses were also Engerix-B, but was not sure about that, and vaccination dates were unknown. The reporter did not consent to follow-up.
Sex: F
Vaccine: RVX
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Drug exposure during pregnancy; Product use in unapproved population; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number HM9851) and (batch number HM9855) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug exposure during pregnancy) and product use in unapproved population (Verbatim: Product use in unapproved population). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were unknown.   Pregnancy exposure: Pregnancy Exposure (RSV vaccine): Trimester unknown Pregnancy Outcome: Lost to follow up   Additional Information: GSK receipt date: 25-JUL-2024 The clinical pharmacist called to verify and verified information in their system and did not appear to be Arexvy. Health care professional (HCP) was not sure if the correct vaccine was Abrysvo.  The patient did not have information about patient's involved. The patient was not sure if it was in fact Arexvy the one administered. The Vaccine Administration Facility was the same as Primary Reporter The pregnant patient seem to be received RSV which led to product use in unapproved population and vaccine exposure during pregnancy. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-JUL-2024 The health care professional (HCP) reported that a patient received the first dose of Shingrix in 2018 and never got the second dose, which led to incomplete course of vaccination. The HCP asked if the they should re-start the series. Consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose of Twinrix on Dec 29, 2023 but did not return for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 21-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 29-DEC-2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first dose of Twinrix on Dec 29, 2023 but did not return for the 2nd dose). The outcome of the incomplete course of vaccination 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: 25-JUL-2024 The pharmacist states a patient received the first dose of Twinrix and did not return for the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: 3rd dose administered; Inappropriate age; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-month-old female patient who received Rota (Rotarix) (batch number LL455, expiry date 11-OCT-2025) for prophylaxis.   Previously administered products included Rotarix (last year).   On 26-JUL-2024, the patient received Rotarix. On 26-JUL-2024, an unknown time after receiving Rotarix, the patient experienced extra dose administered (Verbatim: 3rd dose administered) and inappropriate age at vaccine administration (Verbatim: Inappropriate age). The outcome of the extra dose administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 26-JUL-2024 The nurse called to inform that earlier that day, a 12-month-old patient that had finished their scheme last year (no date specified) and was given an additional dose by accident, which led to extra dose administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2tp74, expiry date 10-JUN-2024) for prophylaxis.   On 21-JUN-2024, the patient received Kinrix. On 21-JUN-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired administration). 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: 26-JUL-2024 Nurse called to report an expired Kinrix vaccine was administered to a patient which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at the injection site after receiving Shingrix; redness and swelling at the injection site after receiving Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: redness and swelling at the injection site after receiving Shingrix) and injection site erythema (Verbatim: redness and swelling at the injection site after receiving Shingrix). The outcome of the injection site swelling and injection site erythema were unknown.   Additional Information: GSK Receipt Date: 26-JUL-2024 Customer reported developing redness and swelling at the injection site after receiving Shingrix.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: inadvertently administered a pediatric dose of Engerix-B to an adult patient; inadvertently administered a pediatric dose of Engerix-B to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 62-year-old male patient who received HBV (Engerix B) (batch number 79S54, expiry date 04-APR-2025) and (batch number 47D3S, expiry date 21-FEB-2026) for prophylaxis.   On 26-JUL-2024, the patient received the 3rd dose of Engerix B. On 26-JUL-2024, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: inadvertently administered a pediatric dose of Engerix-B to an adult patient) and accidental underdose (Verbatim: inadvertently administered a pediatric dose of Engerix-B to an adult patient). The outcome of the adult use of a child product and accidental underdose were not reported.   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: 26-JUL-2024 Nurse practitioner mentioned she inadvertently administered a pediatric dose of Engerix-B to an adult patient on July 26th 2024 which led to adult use of a child product and accidental underdose. Patient received 2 prior Engerix-B doses on January 19th 2024 and on February 20th 2024.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Alopecia areata, Arthropathy, Blood test, Fatigue
Clinical narrative: hair loss and was diagnosed with  Alopecia Areata; Sore arm; Temperature of 100.3 degrees F; patient experience flu like symptoms; Felt really tired; Knee buckled, gave way.; hair loss; fell asleep; This non-serious case was reported by a consumer via call center representative and described the occurrence of alopecia areata in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Had shingles twice, 30 years apart). Previously administered products included Zostavax and Lyme disease.   On 21-MAR-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced alopecia areata (Verbatim: hair loss and was diagnosed with  Alopecia Areata), pain in arm (Verbatim: Sore arm), fever (Verbatim: Temperature of 100.3 degrees F), influenza-like symptoms (Verbatim: patient experience flu like symptoms), tiredness (Verbatim: Felt really tired), joint dysfunction (Verbatim: Knee buckled, gave way.), sleepiness (Verbatim: fell asleep) and hair loss (Verbatim: hair loss). The outcome of the alopecia areata and hair loss were not resolved and the outcome of the pain in arm, fever, influenza-like symptoms, tiredness and joint dysfunction were resolved and the outcome of the sleepiness was resolved (duration 2 hrs).   It was unknown if the reporter considered the alopecia areata, pain in arm, fever, influenza-like symptoms, tiredness, joint dysfunction, sleepiness and hair loss to be related to Shingrix.     It was unknown if the company considered the alopecia areata, pain in arm, fever, influenza-like symptoms, tiredness, joint dysfunction, sleepiness and hair loss to be related to Shingrix.   Additional Information: GSK Receipt date: 26-JUL-2024  The patient was self-reported. She received the first dose of Shingrix on 21 March 2024, shortly after receiving the vaccine, when the paint went to stand up, she felt like she was hit hard by something (the patient had a hard time describing what she meant by this).  After walking around a bit, the patient's knee buckled, gave way, and she felt really tired.  After the patient got home, the patient laid down on the couch and fell asleep for 2 hours.  The patient experience flu like symptoms for two days, and a temperature of 100.3, at the end of the second day, the symptoms were gone as fast as they came.  The patient also had a sore arm, about 1-2 weeks after receiving Shingrix, the patient began to loose hair.  The patient had some blood work, including Thyroid Tests, which were inconclusive.  The patient had been to a dermatologist regarding the hair loss and was diagnosed with Alopecia Areata.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pain in extremity, Somnolence, Thyroid function test
Clinical narrative: hair loss and was diagnosed with  Alopecia Areata; Sore arm; Temperature of 100.3 degrees F; patient experience flu like symptoms; Felt really tired; Knee buckled, gave way.; hair loss; fell asleep; This non-serious case was reported by a consumer via call center representative and described the occurrence of alopecia areata in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Had shingles twice, 30 years apart). Previously administered products included Zostavax and Lyme disease.   On 21-MAR-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced alopecia areata (Verbatim: hair loss and was diagnosed with  Alopecia Areata), pain in arm (Verbatim: Sore arm), fever (Verbatim: Temperature of 100.3 degrees F), influenza-like symptoms (Verbatim: patient experience flu like symptoms), tiredness (Verbatim: Felt really tired), joint dysfunction (Verbatim: Knee buckled, gave way.), sleepiness (Verbatim: fell asleep) and hair loss (Verbatim: hair loss). The outcome of the alopecia areata and hair loss were not resolved and the outcome of the pain in arm, fever, influenza-like symptoms, tiredness and joint dysfunction were resolved and the outcome of the sleepiness was resolved (duration 2 hrs).   It was unknown if the reporter considered the alopecia areata, pain in arm, fever, influenza-like symptoms, tiredness, joint dysfunction, sleepiness and hair loss to be related to Shingrix.     It was unknown if the company considered the alopecia areata, pain in arm, fever, influenza-like symptoms, tiredness, joint dysfunction, sleepiness and hair loss to be related to Shingrix.   Additional Information: GSK Receipt date: 26-JUL-2024  The patient was self-reported. She received the first dose of Shingrix on 21 March 2024, shortly after receiving the vaccine, when the paint went to stand up, she felt like she was hit hard by something (the patient had a hard time describing what she meant by this).  After walking around a bit, the patient's knee buckled, gave way, and she felt really tired.  After the patient got home, the patient laid down on the couch and fell asleep for 2 hours.  The patient experience flu like symptoms for two days, and a temperature of 100.3, at the end of the second day, the symptoms were gone as fast as they came.  The patient also had a sore arm, about 1-2 weeks after receiving Shingrix, the patient began to loose hair.  The patient had some blood work, including Thyroid Tests, which were inconclusive.  The patient had been to a dermatologist regarding the hair loss and was diagnosed with Alopecia Areata.
Sex: M
Vaccine: RVX
Symptoms: Dizziness
Clinical narrative: dizziness; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Illness at time of vaccination included prior unspecified vaccinations.   In JUL-2024, the patient received RSV vaccine. In JUL-2024, an unknown time after receiving RSV vaccine, the patient experienced dizziness (Verbatim: dizziness). The outcome of the dizziness was not resolved.   It was unknown if the reporter considered the dizziness to be related to RSV vaccine.     It was unknown if the company considered the dizziness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-JUL-2024 The reporter was the patient who stated that a couple of days ago he received the Respiratory Syncytial Virus Vaccine and reported that he was just been dizzy the last couple of days. He was not sure if he received name brand Arexvy or if he received another brand of Respiratory Syncytial Virus Vaccine (example Abrysvo). He was administered the vaccine at the pharmacy but did not have a receipt or any paperwork to confirm the manufacture (or the lot number) of what was administered.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Pain
Clinical narrative: 27th of July patient reports feeling achy; a patient got a dose of Arexvy on July 26th 2024 but they forgot they already received a first dose on October 15th 2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number KY322, expiry date 02-FEB-2025) and (batch number 10XX442, expiry date 10-JUL-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 15-OCT-2023 intramuscularly in right arm).   On 26-JUL-2024, the patient received the 2nd dose of Arexvy (intramuscular, right arm). On 26-JUL-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: a patient got a dose of Arexvy on July 26th 2024 but they forgot they already received a first dose on October 15th 2023.). On 27-JUL-2024, the patient experienced pain (Verbatim: 27th of July patient reports feeling achy). The outcome of the pain and extra dose administered were unknown.   It was unknown if the reporter considered the pain to be related to Arexvy.     It was unknown if the company considered the pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 27-JUL-2024 The reporter explained that a patient got a dose of Arexvy on July 26th 2024 but they forgot they already received a first dose on October 15th 2023, which led to extra dose administered. Upon escalation to second line, pharmacist reported that on the 27th of July patient reported feeling achy.  Arexvy was administered intramuscularly in right arm for both doses.  The reporter had not spoken to patient since so unknown whether achy feeling was still occurring or if it resolved. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: forgot to have the second dose administered with the specified time of 2 to 6 months; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: forgot to have the second dose administered with the specified time of 2 to 6 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-JUL-2024 The patient reported that she received the first dose of Shingrix vaccine but forget to had the second dose administered with specified time of 2 to 6 Months. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. This case has been linked to the case US2024AMR095130 reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR095130:Same reporter/Different patient/Husband case
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: the consumer received another dose of AREXVY on 29-JUL-2024 (extra dose.); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number ey77c, expiry date 04-OCT-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 16-JAN-2024).   On 29-JUL-2024, the patient received Arexvy. On 29-JUL-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: the consumer received another dose of AREXVY on 29-JUL-2024 (extra dose.)). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 29-JUL-2024 The reporter reported that the consumer received another dose of Arexvy (extra dose), which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at the injection site). The outcome of the injection site erythema was not reported.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-JUL-2024 The reporter reported that developing redness at the injection site after receiving the Shingrix vaccine.  The reporter initials and DOB (date of birth) were not available. The reporter did not consent to follow-up.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: An expired dose of Priorix was administered to a 3 years old patient.; 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 3-year-old male patient who received MMR (Priorix) (batch number 3XR35, expiry date 01-JUN-2024) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: An expired dose of Priorix was administered to a 3 years old patient.). 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: 30-JUL-2024 The patient received expired Priorix vaccine, which led to expired vaccine used. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose of Bexsero; 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 B NVS (Bexsero) (batch number 9R42C, expiry date 30-JUN-2024) for prophylaxis.   On 30-JUL-2024, the patient received Bexsero. On 30-JUL-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administration of an expired dose of Bexsero). The outcome of the expired vaccine used was not reported.   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: 23-JUL-2024 Medical Assistant reported that the administration of an expired dose of Bexsero to a 16 year old patient on day of reporting which led to expired vaccine used.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: there was approximately 16 months between receiving dose 1 and dose 2; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 84-year-old male patient who received Herpes zoster (Shingrix) (batch number 7354, expiry date 15-NOV-2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th January 2020, batch number:2CP9B and expiry date:12th April 2022).   On 26-MAY-2021, the patient received the 2nd dose of Shingrix. On 26-MAY-2021, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: there was approximately 16 months between receiving dose 1 and dose 2). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 31-JUL-2024 The reporter was the wife of the patient. The reporter reported that there was approximately 16 months between receiving dose 1 and dose 2 of suspect vaccine. (Inappropriate dose schedule). The reporter would like to follow up to be done with administering pharmacy.  She felt that the adverse event was due to not being given an appointment for the second dose. The reporter consented to follow up. The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccinations schedule. The case had been linked to US2024095872, reported by the same reporter for a different patient.; Sender's Comments:  US-GSK-US2024095872:Same reporter/Different patient
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: she had pain on her left arm; She also had an outbreak of shingles on her lower back about a month ago/suspected vaccination failure; had an outbreak of shingles on her lower back about a month ago; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (left arm) and the 1st dose of Shingrix (left arm). In JUN-2024, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: She also had an outbreak of shingles on her lower back about a month ago/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had an outbreak of shingles on her lower back about a month ago). On an unknown date, the patient experienced pain in arm (Verbatim: she had pain on her left arm). The outcome of the vaccination failure was not reported and the outcome of the shingles and pain in arm were resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles and pain in arm to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 31-JUL-2024 This case was reported by patient itself. The patient received 2 doses of Shingrix this year. The patient had pain on her left arm. She also had an outbreak of shingles on her lower back about a month ago. It did not last for long and has resolved.  She did not take any medication for the outbreak. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter did not consent to follow-up.; Sender's Comments: Vaccination failure  is a listed event which is considered related to GSK vaccine  Shingrix (1st dose)and Shingrix(2nd dose)