chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RSV, RSV
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness, Myalgia
Clinical narrative: I am having a lot of joint and muscle pain; I am having a lot of joint and muscle pain; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "I am having a lot of joint and muscle pain".   Additional information: Consumer stated, "I wanted to, I got that RSV shot and I am having a lot of joint and muscle pain and I would went to the doctor and everything else and they say there is nothing to help me with so that's why I went to the pharmacy and they gave me your number so that's what I am calling is what can I do to get my muscle so they are not hurting so bad and so I can motivate and be functional during the day."  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: RSV, RSV
Symptoms: Arthralgia, Myalgia
Clinical narrative: I am having a lot of joint and muscle pain; I am having a lot of joint and muscle pain; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "I am having a lot of joint and muscle pain".   Additional information: Consumer stated, "I wanted to, I got that RSV shot and I am having a lot of joint and muscle pain and I would went to the doctor and everything else and they say there is nothing to help me with so that's why I went to the pharmacy and they gave me your number so that's what I am calling is what can I do to get my muscle so they are not hurting so bad and so I can motivate and be functional during the day."  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Tinnitus
Clinical narrative: Ringing in both ears
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Right axillary swelling with pain
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Neck pain, Pain in extremity, Pruritus
Clinical narrative: sore hot arm with itching; neck and joint aching; head skin sensitivity; sore hot arm with itching; diarrhea; neck and joint aching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (sore hot arm with itching), NECK PAIN (neck and joint aching), SENSITISATION (head skin sensitivity), PAIN IN EXTREMITY (sore hot arm with itching) and DIARRHOEA (diarrhea) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3032680) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-Jan-2024, the patient experienced PRURITUS (sore hot arm with itching), NECK PAIN (neck and joint aching), SENSITISATION (head skin sensitivity), PAIN IN EXTREMITY (sore hot arm with itching), DIARRHOEA (diarrhea) and ARTHRALGIA (neck and joint aching). On 20-Jan-2024, PRURITUS (sore hot arm with itching), NECK PAIN (neck and joint aching), SENSITISATION (head skin sensitivity), PAIN IN EXTREMITY (sore hot arm with itching), DIARRHOEA (diarrhea) and ARTHRALGIA (neck and joint aching) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.  It was unknown if the patient experienced any additional symptoms/events.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2024: Upon internal review done on 07-Feb-2024, significant amendment was performed to update the case country, patient country, vaccine facility country and reporter country.
Sex: F
Vaccine: COVID19
Symptoms: Sensitisation
Clinical narrative: sore hot arm with itching; neck and joint aching; head skin sensitivity; sore hot arm with itching; diarrhea; neck and joint aching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (sore hot arm with itching), NECK PAIN (neck and joint aching), SENSITISATION (head skin sensitivity), PAIN IN EXTREMITY (sore hot arm with itching) and DIARRHOEA (diarrhea) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3032680) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-Jan-2024, the patient experienced PRURITUS (sore hot arm with itching), NECK PAIN (neck and joint aching), SENSITISATION (head skin sensitivity), PAIN IN EXTREMITY (sore hot arm with itching), DIARRHOEA (diarrhea) and ARTHRALGIA (neck and joint aching). On 20-Jan-2024, PRURITUS (sore hot arm with itching), NECK PAIN (neck and joint aching), SENSITISATION (head skin sensitivity), PAIN IN EXTREMITY (sore hot arm with itching), DIARRHOEA (diarrhea) and ARTHRALGIA (neck and joint aching) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.  It was unknown if the patient experienced any additional symptoms/events.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2024: Upon internal review done on 07-Feb-2024, significant amendment was performed to update the case country, patient country, vaccine facility country and reporter country.
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE; 53F for 13 hours 0 minutes 0 seconds; This spontaneous report was received from a medical assistant and refers to a 20-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-JAN-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL, lot #u031051, expiration date: 14-JUN-2024 (vaccination site and route of vaccination was not provided) administered for prophylaxis. The vaccination was administered to one patient after excursion (53F for 13 hours 0 minutes 0 seconds) (product storage error temperature too high). No additional adverse event (AE) or product quality complaint (PQC) was noted.
Age: 60.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; HCP reported a 60-year-old patient received PROQUAD in error and also received it concomitantly with VARIVAX.; HCP reported a 60-year-old patient received PROQUAD in error and also received it concomitantly with VARIVAX.; HCP reported a 60-year-old patient received PROQUAD in error and also received it concomitantly with VARIVAX.; This spontaneous report was received from a medical assistant and referred to a 60-year-old patient of unknown age.  The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 05-JAN-2024, the patient was vaccinated in error with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant Human albumin (rHA), administered for prophylaxis (lot number X019303 has been verified to be a valid lot number, expiration date reported and validated as 14-JAN-2025) (strength, vaccination scheme, anatomical location and route of administration were not provided); administered concomitantly with 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (lot number X021284 has been verified to be a valid lot number, expiration date reported and validated as 20-AUG-2025) (strength, vaccination scheme, anatomical location and route of administration were not provided) (product administered to patient of inappropriate age, wrong product administered and accidental overdose). No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Device malfunction, No adverse event
Clinical narrative: No additional AE; Consumer attempted to self-administer 1 prefilled syringe of GARDASIL 9 and it malfunctioned; Consumer attempted to self-administer 1 prefilled syringe of GARDASIL 9 and it malfunctioned; SRYINGE MALFUNCTIONED WHEN PATIENT WENT TO ADMINISTER IT..; Consumer didn't receive the dose; This spontaneous report was received from Pharmacist and refers to a 51-year-old female patient (Product administered to patient of inappropriate age).  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were unknown by the reporter.  On 19-JAN-2024, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was dispensed to the patient, and on an unspecified date in January 2024 (also reported as past weekend), the patient attempted to self-administer (Product use issue) 1 prefilled syringe of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # U031051 and expiration date: 14-JUN-2024, as prophylaxis (strength, and route of administration were not provided) and it malfunctioned (Device malfunction and poor quality device used), and she did not receive the dose (Product dose omission issue) with no report of injury nor additional adverse event (AE). It was reported that it was unknown if it is available for return/obtain, however, also reported that the product was available to obtain (conflicting information).
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; 17-year-old patient inadvertently received vaccine; This spontaneous report was received from a medical assistant and referred to a 17-year-old patient with unknown gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 02-FEB-2024, the patient was inadvertently vaccinated with the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection (lot number X021131 has been verified to be a valid lot number and expiration date was 12-FEB-2025, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) (no adverse event).
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: The HCP reported a 12 month old patient inadvertently received a dose of VARIVAX and PROQUAD, instead of receiving VARIVAX and MMR II.; The HCP reported a 12 month old patient inadvertently received a dose of VARIVAX and PROQUAD, instead of receiving VARIVAX and MMR II.; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient inadvertently received a dose of varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection and measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection diluted in sterile diluent, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) instead of receiving varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection and measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) injection (Wrong product administered) (Extra dose administered).
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female, Breast mass, Hypermetabolism, Lymphadenopathy, Positron emission tomogram
Clinical narrative: Hypermetabolic Axillary Lymphadenopathy/contralateral axillary lymph nodes enlarge with avid FDG uptake; diagnosed breast cancer; This serious case was reported in a literature article and described the occurrence of lymphadenopathy axillary in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.    On an unknown date, the patient received Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced lymphadenopathy axillary (Verbatim: Hypermetabolic Axillary Lymphadenopathy/contralateral axillary lymph nodes enlarge with avid FDG uptake) and breast cancer (Verbatim: diagnosed breast cancer) (serious criteria GSK medically significant). The outcome of the lymphadenopathy axillary and breast cancer were not reported.   The reporter considered the lymphadenopathy axillary and breast cancer to be related to Shingrix.     The company considered the lymphadenopathy axillary and breast cancer to be related to Shingrix.   Additional Information: GSK receipt- 05 Feb 2024 A 67-year-old woman underwent staging 18 F-FDG PET/CT scan for recently diagnosed breast cancer. Her scan showed a highly hypermetabolic right breast mass, with ipsilateral hypermetabolic axillary lymph nodes. The contralateral axillary lymph nodes were also enlarged with avid FDG uptake, alongside focal increased uptake in the left deltoid muscle. Upon investigation, the patient reported receiving the new zoster recombinant adjuvanted varicella zoster vaccine (Shingrix, GlaxoSmithKline) 4 days before the scan. The lymph node uptake could be potential pitfall for cancer staging.
Sex: F
Vaccine: VARZOS
Symptoms: Positron emission tomogram abnormal
Clinical narrative: Hypermetabolic Axillary Lymphadenopathy/contralateral axillary lymph nodes enlarge with avid FDG uptake; diagnosed breast cancer; This serious case was reported in a literature article and described the occurrence of lymphadenopathy axillary in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.    On an unknown date, the patient received Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced lymphadenopathy axillary (Verbatim: Hypermetabolic Axillary Lymphadenopathy/contralateral axillary lymph nodes enlarge with avid FDG uptake) and breast cancer (Verbatim: diagnosed breast cancer) (serious criteria GSK medically significant). The outcome of the lymphadenopathy axillary and breast cancer were not reported.   The reporter considered the lymphadenopathy axillary and breast cancer to be related to Shingrix.     The company considered the lymphadenopathy axillary and breast cancer to be related to Shingrix.   Additional Information: GSK receipt- 05 Feb 2024 A 67-year-old woman underwent staging 18 F-FDG PET/CT scan for recently diagnosed breast cancer. Her scan showed a highly hypermetabolic right breast mass, with ipsilateral hypermetabolic axillary lymph nodes. The contralateral axillary lymph nodes were also enlarged with avid FDG uptake, alongside focal increased uptake in the left deltoid muscle. Upon investigation, the patient reported receiving the new zoster recombinant adjuvanted varicella zoster vaccine (Shingrix, GlaxoSmithKline) 4 days before the scan. The lymph node uptake could be potential pitfall for cancer staging.
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Mass, Pain, Skin discolouration
Clinical narrative: Redness and itching at the injection site for 9 days; Redness and itching at the injection site for 9 days; Wrong injection technique; stinging; Small lump; black and blue mark; black and blue mark; This non-serious case was reported by a consumer and described the occurrence of injection site itching in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included lisinopril.   On 19-JAN-2024, the patient received Arexvy. In JAN-2024, an unknown time after receiving Arexvy, the patient experienced stinging (Verbatim: stinging), mass (Verbatim: Small lump), blue skin (Verbatim: black and blue mark) and skin discoloration (Verbatim: black and blue mark). On 19-JAN-2024, the patient experienced injection site itching (Verbatim: Redness and itching at the injection site for 9 days), injection site erythema (Verbatim: Redness and itching at the injection site for 9 days) and wrong injection technique (Verbatim: Wrong injection technique). On 28-JAN-2024, the outcome of the injection site itching and injection site erythema were resolved (duration 9 days). The outcome of the stinging was not reported and the outcome of the mass, blue skin and skin discoloration were not resolved and the outcome of the wrong injection technique was unknown.   It was unknown if the reporter considered the injection site itching, injection site erythema, stinging, mass, blue skin and skin discoloration to be related to Arexvy.     It was unknown if the company considered the injection site itching, injection site erythema, stinging, mass, blue skin and skin discoloration to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-JAN-2024 This report was submitted via the online direct entry reporting system.  The reporter asked just trying to determine if it was a local reaction the activated virus or the adjuvant.  Never experienced the intense itching and stinging for that many days after a vaccination.  The patient also believed the pharmacist hit a blood vessel due to the fact still had a small lump and a black and blue mark, which led to wrong injection technique.
Sex: F
Vaccine: RSV
Symptoms: Wrong technique in product usage process
Clinical narrative: Redness and itching at the injection site for 9 days; Redness and itching at the injection site for 9 days; Wrong injection technique; stinging; Small lump; black and blue mark; black and blue mark; This non-serious case was reported by a consumer and described the occurrence of injection site itching in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included lisinopril.   On 19-JAN-2024, the patient received Arexvy. In JAN-2024, an unknown time after receiving Arexvy, the patient experienced stinging (Verbatim: stinging), mass (Verbatim: Small lump), blue skin (Verbatim: black and blue mark) and skin discoloration (Verbatim: black and blue mark). On 19-JAN-2024, the patient experienced injection site itching (Verbatim: Redness and itching at the injection site for 9 days), injection site erythema (Verbatim: Redness and itching at the injection site for 9 days) and wrong injection technique (Verbatim: Wrong injection technique). On 28-JAN-2024, the outcome of the injection site itching and injection site erythema were resolved (duration 9 days). The outcome of the stinging was not reported and the outcome of the mass, blue skin and skin discoloration were not resolved and the outcome of the wrong injection technique was unknown.   It was unknown if the reporter considered the injection site itching, injection site erythema, stinging, mass, blue skin and skin discoloration to be related to Arexvy.     It was unknown if the company considered the injection site itching, injection site erythema, stinging, mass, blue skin and skin discoloration to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-JAN-2024 This report was submitted via the online direct entry reporting system.  The reporter asked just trying to determine if it was a local reaction the activated virus or the adjuvant.  Never experienced the intense itching and stinging for that many days after a vaccination.  The patient also believed the pharmacist hit a blood vessel due to the fact still had a small lump and a black and blue mark, which led to wrong injection technique.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I had the first Shingrix vaccine in 2019 and patient is currently 51 years old; I had the first Shingrix vaccine in 2019 but was unable to get the 2nd dose; This non-serious case was reported by a consumer and described the occurrence of inappropriate age at vaccine administration in a 51-year-old 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 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: I had the first Shingrix vaccine in 2019 and patient is currently 51 years old) and incomplete course of vaccination (Verbatim: I had the first Shingrix vaccine in 2019 but was unable to get the 2nd dose). The outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 01-Feb-2024 The patient received the first dose of Shingrix vaccine in 2019 but he or she was unable to receive the 2nd dose due to a change in insurance. The reporter stated that neither physician nor pharmacist are able to advise if ok to receive the second does now or do he or she need to receive both the first and second dose again. The patient received Shingrix vaccine who was younger than the indicated age which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient experienced migratory paresthesia in arm/ legs; This non-serious case was reported by a physician via sales rep and described the occurrence of paresthesia of limbs in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced paresthesia of limbs (Verbatim: Patient experienced migratory paresthesia in arm/ legs). The outcome of the paresthesia of limbs was resolved.   It was unknown if the reporter considered the paresthesia of limbs to be related to Shingrix.     It was unknown if the company considered the paresthesia of limbs to be related to Shingrix.   Additional Information: GSK receipt date: 01-FEB-2024 The reporter reported that the patient experienced migratory paresthesia in arms and legs after receiving 1st dose of Shingrix vaccine. The reporter stated that it went away and did not happened again when the 2nd dose was given. The reporter did not consent to follow-up.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Pharmacist reported that when they opened the box of Menveo (2 vial) they found an extra diluent in the box and believe that one of the 3 patients from Jan 2023 until now received it.; Found an extra diluent in the box and believe that one of the 3 patients from Jan 2023 until now received it/Non-approved diluent for reconstitution; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA933A, expiry date 30-JUN-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Pharmacist reported that when they opened the box of Menveo (2 vial) they found an extra diluent in the box and believe that one of the 3 patients from Jan 2023 until now received it.) and inappropriate dose of vaccine administered (Verbatim: Found an extra diluent in the box and believe that one of the 3 patients from Jan 2023 until now received it/Non-approved diluent for reconstitution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-JAN-2024 The pharmacist reported that when they opened the box of Menveo (2 vial) they found an extra diluent in the box. The pharmacist believed that one of the 3 patients from Jan 2023 until the time of reporting (now) received it.  The pharmacist was not sure who it was among the 3 patients.  One of the 3 patients received extra diluent from the box (non-approved diluent for reconstitution), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  The reporter consented to follow up via phone.; Sender's Comments:  US-GSK-US2024011341:1st patient US-GSK-US2024AMR015888:2 ND PATIENT
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administering the diluent for the Shingrix Vaccine by itself without the Vaccine; administering the diluent for the Shingrix Vaccine by itself without the Vaccine; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of inappropriate preparation of medication in a 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 inappropriate preparation of medication (Verbatim: administering the diluent for the Shingrix Vaccine by itself without the Vaccine) and inappropriate dose of vaccine administered (Verbatim: administering the diluent for the Shingrix Vaccine by itself without the Vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-Jan-2024 The reporter reported that the patient administered the diluent for the Shingrix vaccine by itself without the vaccine. The reporter confirmed there are no symptoms and no additional details provided. The reporter gave by error Shingrix diluent portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered only adjuvant component of Arexvy in error; administered only adjuvant component of Arexvy in error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 45mg3, expiry date 10-JUL-2025) for prophylaxis.   On 11-JAN-2024, the patient received Arexvy. On 11-JAN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: administered only adjuvant component of Arexvy in error) and inappropriate dose of vaccine administered (Verbatim: administered only adjuvant component of Arexvy in error). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-JAN-2024 The patient was administered only adjuvant component of Arexvy in error, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This was 1 of 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024013412:2nd patient US-GSK-US2024013415:5th patient US-GSK-US2024013414:4th patient US-GSK-US2024013410:1st patient
Age: 61.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: report a 61 year old patient received Bexsero on 27-Jan-2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 61-year-old female patient who received Men B NVS (Bexsero) (batch number 5pzp7, expiry date 31-JAN-2026) for prophylaxis.   On 27-JAN-2024, the patient received Bexsero. On 27-JAN-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: report a 61 year old patient received Bexsero on 27-Jan-2024). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 29-JAN-2024 The reporter called to report a 61 year old patient received Bexsero which led to inappropriate age at vaccine administration. The reporter was unsure of why the vaccine was given as a floater pharmacist administered. The reporter consented to follow up
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered Shingrix series with only 2 weeks between doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 597C4, expiry date 04-AUG-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 13-MAY-2023, the patient received the 2nd dose of Shingrix. On 13-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: administered Shingrix series with only 2 weeks between doses). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 29-JAN-2024 The pharmacist stated that patient was administered Shingrix series with only 2 weeks between doses.  The vaccine administration facility was the same as primary reporter. The reporter consented to the follow up.  The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: patient was administered frozen Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On 01-NOV-2023, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: patient was administered frozen Engerix-B). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-JAN-2024 A medical assistant reported that a patient was administered frozen Engerix B. On 9th October 2023, the vaccine went down to minimum 26.6 F (Fahrenheit) for 2 hours and 35 minutes, which led to incorrect storage of drug. The reporter consented to follow up. This was 1 of the 6 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024013465:Same reporter US-GSK-US2024013459:Same reporter US-GSK-US2024013461:Same reporter US-GSK-US2024013458:Same reporter US-GSK-US2024013455:Same reporter
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Product distribution issue, Product storage error
Clinical narrative: administration of Engerix-B that was delivered after 5 days shipping, was "out of storage range" when received; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old male patient who received HBV (Engerix B pediatric) (batch number H39Z4, expiry date 04-DEC-2025) for prophylaxis.   On 29-JAN-2024, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced incorrect storage of drug (Verbatim: administration of Engerix-B that was delivered after 5 days shipping, was "out of storage range" when received). The outcome of the incorrect storage of drug was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 29-JAN-2024 The Licensed practical nurses requested the stability data and Centers for Disease Control and Prevention recommendations after the administration of Engerix-B that was delivered 5 days shipping was out of storage range when received. The specific time and temperature for storage condition was unknown. The reporter stated that distributor would replace and refund vaccines. Vaccines were delivered on the day of reporting and administered to 2 patients on the day of reporting, which led to incorrect storage of drug. The reporter consented to follow-up. This case has been linked to the US2024013462, reported by the same reporter.; Sender's Comments:  US-GSK-US2024013462:Same reporter/ Different patient
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 month old was inadvertently administered a Kinrix dose on 1/30/24 in the Right Thigh; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-week-old male patient who received DTPa-IPV (Kinrix) (batch number D472T, expiry date 22-MAR-2024) for prophylaxis.   On 30-JAN-2024, the patient received Kinrix (right thigh). On 30-JAN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 month old was inadvertently administered a Kinrix dose on 1/30/24 in the Right Thigh). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 31-JAN-2024 The reporter called to inquire that how to proceed and what to look in the patient. The reporter reported that a 2 month old was inadvertently administered a Kinrix dose in the right thigh, which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: needs to restart the series as the interval between the first dose and 2nd dose of shingrix was longer than the recommended interval; 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 89-year-old female patient who received Herpes zoster (Shingrix) (batch number 44HD4, expiry date 30-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th April 2022, Batch number:5SC3X).   On 03-AUG-2023, the patient received the 2nd dose of Shingrix. On 03-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: needs to restart the series as the interval between the first dose and 2nd dose of shingrix was longer than the recommended interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2024 The reporter would like to know if a patient (not immunocompromised) need to restart the series as the interval between the first dose and 2nd dose of Shingrix was longer than the recommended interval.  3rd dose of Shingrix was not given. The reporter consented to follow up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Overdose; Adult Havrix dose to pediatric patient; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 7-year-old female patient who received HAV (Havrix adult) for prophylaxis.   In JAN-2024, the patient received Havrix adult. In JAN-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: Overdose) and adult product administered to child (Verbatim: Adult Havrix dose to pediatric patient). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 31-DEC-2024 Physician stated that patient had presented no symptoms after the dose. The reporter mentioned before calling was doing internet research on the topic and find a study were adult Havrix was administered to over 100 pediatric patients but stated results did not clarify symptoms presented by patients. The physician called to report an adult dose of Havrix was administered to his 7 year old patient, which led to under dose and adult dose administered to the child patient.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: not received their second dose of Shingrix yet after receiving the first dose about four years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose about four years ago).   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: not received their second dose of Shingrix yet after receiving the first dose about four years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2024 A pharmacist reported that a patient had not received their second dose of Shingrix yet. Till the time of reporting the patient had not receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Bronchitis, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: they got the vaccine still ended up for rsv/vaccination failure; still ended up in hospital for rsv.; they got the vaccine still ended up in hospital for bronchitis.; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: they got the vaccine still ended up for rsv/vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: still ended up in hospital for rsv.) and bronchitis (Verbatim: they got the vaccine still ended up in hospital for bronchitis.). The outcome of the vaccination failure, respiratory syncytial virus infection and bronchitis were unknown.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and bronchitis to be related to Arexvy.     It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection and bronchitis to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-JAN-2024 The physician asked what was timeline between getting vaccinated to patient protected? The reporter said her patient told her they got the vaccine still ended up in hospital for Respiratory syncytial virus infection and bronchitis. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding RSV were unknown at the time of reporting. No further information. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of Shingrix on 01Nov2018 and a late 2nd dose on 31Jan2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug administration duration too long in a female patient who received Herpes zoster (Shingrix) (batch number J743F, expiry date 11-DEC-2025) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix vaccine).   On 31-JAN-2024, the patient received the 2nd dose of Shingrix. On 31-JAN-2024, an unknown time after receiving Shingrix, the patient experienced drug administration duration too long (Verbatim: 1st dose of Shingrix on 01Nov2018 and a late 2nd dose on 31Jan2024). The outcome of the drug administration duration too long was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2024 The other health professional reported that the patient received 2nd dose late. The reporter did not had date of birth at time of report. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The reporter consented to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: H reported a patient was inadvertently administered an expired Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number E3594, expiry date 18-JAN-2024) for prophylaxis.   On 26-JAN-2024, the patient received Boostrix. On 26-JAN-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: H reported a patient was inadvertently administered an expired Boostrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date:31-JAN-2024 The reporter called to inquire that how to proceed. The reporter reported that a patient was inadvertently administered an expired Boostrix, which led to expired vaccine used.  The reporter declined to provide patient details. The reporter did not consent to follow-up.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose of Hiberix; 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 2-month-old female patient who received Hib (Hiberix) (batch number 7FZ57, expiry date 30-DEC-2023) for prophylaxis.   On 30-JAN-2024, the patient received Hiberix. On 30-JAN-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: administration of an expired dose of Hiberix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 01-FEB-2024 The medical assistant called to report the administration of an expired dose of Hiberix to a 2 month-old patient. The HCP asked for guidance on this situation. The patient received vaccine was expired on 30 December 2023, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Hiberix  reconstituted with Non-GSK diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On 31-JAN-2024, the patient received Hiberix. On 31-JAN-2024, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Hiberix  reconstituted with Non-GSK diluent). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 01-FEB-2024 The health care professional (HCP) reported that they found an extra diluent and its an assumption that the Hiberix powder was diluted with sterile water. The patient received vaccine with sterile water, which led to wrong solution used for vaccine reconstitution.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Deep vein thrombosis, Swelling
Clinical narrative: Excessive swelling; Deep vein thrombosis (DVT); This serious case was reported by a other health professional via call center representative and described the occurrence of deep vein thrombosis in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 26-JAN-2024, an unknown time after receiving Shingrix, the patient experienced deep vein thrombosis (Verbatim: Deep vein thrombosis (DVT)) (serious criteria GSK medically significant). On an unknown date, the patient experienced swelling (Verbatim: Excessive swelling). The outcome of the deep vein thrombosis and swelling were unknown.   It was unknown if the reporter considered the deep vein thrombosis and swelling to be related to Shingrix.     It was unknown if the company considered the deep vein thrombosis and swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-Feb-2024 The reporter reported that the patient received Shingrix vaccination and 2 weeks later developed excessive swelling.   The patient was sent to the emergency department on 26th January 2024 and was diagnosed with a deep vein thrombosis. No further information was known. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: WOULD RUIN MY LIFE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose series:1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced would ruin my life. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of would ruin my life was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000310168.