chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: she received Shingrix vaccines on June 2 and July 10 at the pharmacy; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included the patient was not immunocompromised. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 10-JUL-2023, the patient received the 2nd dose of Shingrix. On 10-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: she received Shingrix vaccines on June 2 and July 10 at the pharmacy). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 20-JUL-2023 The reporter did not agree to follow up from GSK. The patient received 2nd dose before recommended interval, which led to shortening of vaccination schedule.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperaesthesia, Insomnia, Pain, Pruritus
Clinical narrative: skin sensitivity; She was not able to sleep the past two nights; due to the itching/body-wide itching; body aches; fever; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of sensitive skin in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose and developed back pain, refer case US2023098120). Concurrent medical conditions included celiac disease.   On 12-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm). On 13-JUL-2023, 1 days after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches), fever (Verbatim: fever) and headache (Verbatim: headache). On 15-JUL-2023, the patient experienced sensitive skin (Verbatim: skin sensitivity), insomnia (Verbatim: She was not able to sleep the past two nights) and pruritus (Verbatim: due to the itching/body-wide itching). The patient was treated with fexofenadine hydrochloride (Allegra). Rechallenge with Shingrix was positive. On 14-JUL-2023, the outcome of the general body pain, fever and headache were resolved (duration 1 day). The outcome of the sensitive skin, insomnia and pruritus were not resolved.   It was unknown if the reporter considered the sensitive skin, insomnia, pruritus, general body pain, fever and headache to be related to Shingrix.     It was unknown if the company considered the sensitive skin, insomnia, pruritus, general body pain, fever and headache to be related to Shingrix.   Linked case(s) involving the same patient:  US2023098120   Additional Information: GSK receipt date: 17-Jul-2023 The patient received her second Shingrix dose and next day she again had fever, headache and body aches.  3 days after the vaccination, the patient experienced body-wide itching and skin sensitivity.  Water, heat, sweating and any touch triggers the intense itching.  The patient was not able to sleep the past two nights due to the itching and she spoke with the on-call physician over the weekend (15th July 2023 or 16th July 2023) and was told to take Allegra.  The Allegra had not relieved the itching and did not had a rash.  Nothing else was reported. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2023098120:same patient, first dose
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sensitive skin, Sleep disorder, Temperature intolerance
Clinical narrative: skin sensitivity; She was not able to sleep the past two nights; due to the itching/body-wide itching; body aches; fever; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of sensitive skin in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose and developed back pain, refer case US2023098120). Concurrent medical conditions included celiac disease.   On 12-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm). On 13-JUL-2023, 1 days after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches), fever (Verbatim: fever) and headache (Verbatim: headache). On 15-JUL-2023, the patient experienced sensitive skin (Verbatim: skin sensitivity), insomnia (Verbatim: She was not able to sleep the past two nights) and pruritus (Verbatim: due to the itching/body-wide itching). The patient was treated with fexofenadine hydrochloride (Allegra). Rechallenge with Shingrix was positive. On 14-JUL-2023, the outcome of the general body pain, fever and headache were resolved (duration 1 day). The outcome of the sensitive skin, insomnia and pruritus were not resolved.   It was unknown if the reporter considered the sensitive skin, insomnia, pruritus, general body pain, fever and headache to be related to Shingrix.     It was unknown if the company considered the sensitive skin, insomnia, pruritus, general body pain, fever and headache to be related to Shingrix.   Linked case(s) involving the same patient:  US2023098120   Additional Information: GSK receipt date: 17-Jul-2023 The patient received her second Shingrix dose and next day she again had fever, headache and body aches.  3 days after the vaccination, the patient experienced body-wide itching and skin sensitivity.  Water, heat, sweating and any touch triggers the intense itching.  The patient was not able to sleep the past two nights due to the itching and she spoke with the on-call physician over the weekend (15th July 2023 or 16th July 2023) and was told to take Allegra.  The Allegra had not relieved the itching and did not had a rash.  Nothing else was reported. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2023098120:same patient, first dose
Sex: F
Vaccine: VARZOS
Symptoms: Antiviral treatment, Eyelid rash, Herpes zoster, Rash
Clinical narrative: shingles rash on her forehead and extending into scalp; Shingles rash on left eyelid; Shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3ZX3E, expiry date 02-JUL-2025) for prophylaxis.   On 07-JUL-2023, the patient received the 1st dose of Shingrix. On 09-JUL-2023, 2 days after receiving Shingrix, the patient experienced rash (Verbatim: shingles rash on her forehead and extending into scalp), eyelid rash (Verbatim: Shingles rash on left eyelid) and shingles (Verbatim: Shingles). The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the rash, eyelid rash and shingles were not resolved.   It was unknown if the reporter considered the rash, eyelid rash and shingles to be related to Shingrix.     It was unknown if the company considered the rash, eyelid rash and shingles to be related to Shingrix.   Additional Information: GSK Receipt date: 17-JUL-2023 A Pharmacist reported that a patient received first dose of Shingrix on 07 July 2023. The patient stated that two days later she developed shingles rash on her forehead, extending into scalp and on left eyelid. Rash confirmed as shingles by her physician, and she was prescribed an antiviral medication. The Pharmacist states the patient is otherwise healthy and was not on any medications prior. The pharmacist spoke with the patient on 16 July 2023 and at that time, the rash was still ongoing. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she has not received the 2nd dose and it has been 10 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 in left arm at a local pharmacy in September 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: she has not received the 2nd dose and it has been 10 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-Jul-2023 The patient reported that she has not received the 2nd dose and it had been 10 months since the 1st dose.  Lot and expiry date were not provided.  The customer had been transferred several times during the call and requested information for financial assistance for the 2nd dose of Shingrix and requested the information as soon as possible.  The customer reported that having insurance for her 1st dose of Shingrix but did not have insurance coverage for the 2nd dose.  The consumer did not provided additional information. Not all information was available.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 3.0
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a pharmacist reported that a 3 years old patient received a bexsero dose; 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 3-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: a pharmacist reported that a 3 years old patient received a bexsero dose). 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: 18-Jul-2023 The reporter consented to follow-up. The patient received a dose of Bexsero at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the liquid portion of Menveo; only the liquid portion of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA944A, expiry date 31-JUL-2024) for prophylaxis.   On 06-JUL-2023, the patient received Menveo. On 06-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only the liquid portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: only the liquid portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 The patient received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: clinic stating that the vaccine had been exposed to inappropriate temperatures; 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 62-year-old female 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 incorrect storage of drug (Verbatim: clinic stating that the vaccine had been exposed to inappropriate temperatures). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 18 Jul 2023 Medical assistant stated that a patient received her first dose of Shingrix at another clinic which was now closed. The patient reportedly received a call from the other clinic stating that the vaccine had been exposed to inappropriate temperatures. No other information was available. The second dose was administered at the reporter's clinic on 6-JUL-2023. The reporter only consented to follow-up via phone call. The patient received Shingrix that had been exposed to inappropriate temperatures, which led to incorrect storage of drug.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: wrong dose for age; wrong dose for age; This non-serious case was reported by a other health professional via sales rep and described the occurrence of overdose in a 19-year-old patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult 20 ug. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: wrong dose for age) and inappropriate age at vaccine administration (Verbatim: wrong dose for age). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 A 19-year-old patient received Engerix B Adult 20 mcg which was not indicated until w-years, which led to overdose and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered a dose of Boostrix on 18Jul2023 from lot number HF2YA, which had an expiration date of 15Jul2023; 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 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 18-JUL-2023, the patient received Boostrix. On 18-JUL-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Boostrix on 18Jul2023 from lot number HF2YA, which had an expiration date of 15Jul2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 The reporter was a medical assistant. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received Boostrix which was already expired, which led to expired vaccine used.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first dose of Shingrix 18Dec2021 and did not receive second dose until 18May 2023; 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 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18-DEC-2021).   On 18-MAY-2023, the patient received the 2nd dose of Shingrix. On 18-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received first dose of Shingrix 18Dec2021 and did not receive second dose until 18May 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 At the time of reporting, the pharmacist did not had the dosing lot numbers. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Reporter was a floater, so might have to follow-up with different staff member. The patient received 2nd dose of Shingrix later than recommended interval, which led to lengthening of vaccination schedule.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: accidently given an adult dose of ENGERIX B; accidently given an adult dose of ENGERIX B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 4-year-old female patient who received HBV (Engerix B adult) (batch number d23d3, expiry date 15-MAR-2025) for prophylaxis.   On 18-JUL-2023, the patient received Engerix B adult. On 18-JUL-2023, an unknown time after receiving Engerix B adult, the patient experienced accidental overdose (Verbatim: accidently given an adult dose of ENGERIX B) and adult product administered to child (Verbatim: accidently given an adult dose of ENGERIX B). The outcome of the accidental overdose and adult product administered to child 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: 18-JUL-2023 The reporter was a medical assistant. A 4-year-old patient was accidently given an adult dose of Engerix B, which led to accidental overdose and adult product administered to child. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Wrong Vaccine Administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a patient who received Herpes zoster (Shingrix) (batch number 299J9, expiry date 01-JUL-2023) for prophylaxis.   In JAN-2023, the patient received Shingrix. In JAN-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Wrong Vaccine Administered). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date 19 Jul 2023: The pharmacy buyer reported that Shingrix vaccine administered instead of Twinrix in January 2023.  No additional details were available. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. The patient received Shingrix vaccine instead of Twinrix which led to wrong vaccine administered.
Age: 41.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo only liquid portion administered; Menveo only liquid portion administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 41-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA762A) for prophylaxis.   On 19-JUL-2023, the patient received Menveo. On 19-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: Menveo only liquid portion administered) and inappropriate preparation of medication (Verbatim: Menveo only liquid portion administered). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date 19 Jul 2023 The nurse reported only the liquid portion of Menveo was administered to a patient. The reporter consented to follow up.  Patients initial asked and declined. The nurse reported only the liquid portion of Menveo was administered to a patient, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Dose Administered; 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-month-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 17-JUL-2023, the patient received Infanrix. On 17-JUL-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). 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: 19-JUL-2023 Clinical Manager states an expired dose of Infanrix was administered to a patient, which led to expired vaccine used. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up via postal.
Age: 1.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a patient of 18 months of age received a dose of Kinrix; 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 18-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a patient of 18 months of age 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: 19-JUL-2023 A nurse called to inform that earlier that day, a patient of 18 months of age received a dose of Kinrix, which led to inappropriate age at vaccine administration. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received a HepB vaccination as an infant but did not complete the series; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 11-year-old patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (on an unknown date received 1st dose as infant ).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: received a HepB vaccination as an infant but did not complete the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 19-JUL-2023 A nurse reported about a patient who received a Hepatitis B vaccination as an infant but did not complete the series.  The reporter did not know if the first Hepatitis B dose was Engerix-B.  The HCP mentioned that they administered Engerix-B to this patient and asked if Engerix-B could be use for catch up.  The reporter declined to share patient information and data regarding the Engerix-B given. Till the time of reporting the patient had not received the second dose of Engerix-B, which led to incomplete course of vaccination.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient had 1st Shingrix in 10DEC2019 and received 2nd dose on 17JUL2023; 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 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 49EL9, expiry date 07-FEB-2024) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose on 10th December 2019).   On 19-JUL-2023, the patient received the 2nd dose of Shingrix. On 19-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient had 1st Shingrix in 10DEC2019 and received 2nd dose on 17JUL2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 19-Jul-2023 The reporter consented to follow-up. The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix administration after freezing exposure; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old male patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced incorrect storage of drug (Verbatim: Havrix administration after freezing exposure). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Jul-2023 The reporter consented to follow-up. The patient received a Havrix dose exposed at 28 degree Fahrenheit, which led to incorrect storage of drug.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: received a kinrix dose exposed at 28 degree F / Kinrix administration after freezing; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: received a kinrix dose exposed at 28 degree F / Kinrix administration after freezing). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JUL-2023 The reporter consented to follow up. The patient received a Kinrix dose exposed at 28 degree F, which led to incorrect storage of drug.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; Inappropriate Reconstitution Technique; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-JUL-2023 Reporter was a GSK representative who was reporting on behalf of an HCP (office manager) who stated that an unknown number of patients were administered a dose of Menveo with just the liquid conjugate component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 months old patient received a kinrix dose by mistake; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 4 months old patient received a kinrix dose by mistake). 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: 20-JUL-2023 A physician reported that a 4 months old patient received a kinrix dose by mistake, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 12-year-old patient received an adult dose of Havrix; 12-year-old patient received an adult dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 12-year-old male patient who received HAV (Havrix adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 06-JUL-2023, the patient received Havrix adult. On 06-JUL-2023, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: 12-year-old patient received an adult dose of Havrix) and inappropriate age at vaccine administration (Verbatim: 12-year-old patient received an adult dose of Havrix). The outcome of the overdose 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: 20-JUL-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. 12-year-old patient received an adult dose of Havrix, which led to overdose and inappropriate age at vaccine administration.
Sex: F
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 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2019).   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: 20-JUL-2023 A pharmacist called to ask for information regarding patient who received the first dose of Shingrix back in August 2019. The health care professional asked if the patient needed to restart the series. The health care professional did not provide lot number and expiry date of the first Shingrix dose. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Eyelid rash, Pyrexia, Rash
Clinical narrative: skin rash yesterday in the forehead and scalp, also near the left eyelid that persist; chills; fever; This non-serious case was reported by a physician via sales rep and described the occurrence of skin rash in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 44T97, expiry date 18-SEP-2023) for prophylaxis.   On 14-JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, several days after receiving Shingrix, the patient experienced chills (Verbatim: chills) and fever (Verbatim: fever). On 19-JUL-2023, the patient experienced skin rash (Verbatim: skin rash yesterday in the forehead and scalp, also near the left eyelid that persist). The outcome of the skin rash was not resolved and the outcome of the chills and fever were resolved.   It was unknown if the reporter considered the skin rash, chills and fever to be related to Shingrix.     It was unknown if the company considered the skin rash, chills and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUL-2023 The reporter is a physician who informed Representative that the patient received first dose of Shingrix on 14th July 2023 and everything was fine.  Then patient called today 20th July 2023 to report he had fever and chills a couple of days after vaccination and went away.  The patient developed a skin rash yesterday in the forehead and scalp, also near the left eyelid that persist.  Medical office contacted. Information verified with nurse. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late 2nd dose; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2022 ).   In MAY-2023, the patient received the 2nd dose of Shingrix. In MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-JUL-2023 A pharmacist reported that a patient received the 1st dose of Shingrix in March 2022 and a late 2nd dose in May 2023 which led to lengthening of vaccination schedule. The vaccine administration facility is the same as primary reporter. The health care professional did not have the exact date of vaccination or lot number or expiration details.  The reporter consented to follow up via email.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: LATE 2ND DOSE; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th January 2022).   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: LATE 2ND DOSE). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-JUL-2023 The health care professional reported that patient received 1st dose of Shingrix on 01/24/2022 and is in the office to receive dose 2, now which led to lengthening of vaccination schedule. The vaccine administration facility is the same as primary reporter. The health care professional did not have the exact date of vaccination or lot number or expiration details.  The reporter consented to follow up via email.
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: sinus infection; This non-serious case was reported by a consumer via call center representative and described the occurrence of sinus infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-JUL-2023, the patient received the 2nd dose of Shingrix. On 20-JUL-2023, 8 days after receiving Shingrix, the patient experienced sinus infection (Verbatim: sinus infection). The outcome of the sinus infection was not resolved.   It was unknown if the reporter considered the sinus infection to be related to Shingrix.     It was unknown if the company considered the sinus infection to be related to Shingrix.   Additional Information: GSK receipt date: 20-Jul-2023 The patient received a dose of Shingrix  and was diagnosed with a sinus infection on the day of reporting and was ordered to start prednisone (tomorrow).  The patient would call her primary care practitioner (PCP) and make sure it was ok to start the steroid.  Adverse event was filed with limited information.  Spoken as per package insert and offered package insert.  Referred to health care professional. Did not consent to follow-up.
Age: 0.83
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a 10-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 22-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.).    Concomitant medication was not provided.  Patient was administered with Monovalent Moderna vaccine as first dose on 20-Mar-2023, at a dose of 25mcg with batch no: AS1903B.  Patient was given with appropriate vaccine or scheduled as per CDC.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2023: Follow-up received, contains non-significant information. On 20-Jul-2023: Follow-up received and added patient initials and details, added secondary reporter, added primary reporter information, added dosage information of suspect, added onset date of event and I narrative updated.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administration of expired drug; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired drug) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 18-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired drug). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired drug) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administration of expired drug).    Concomitant medications were not reported.  On 7/18/2023 patient administered a 0.5 mL dose of Moderna 6+ bivalent booster who had never been vaccinated. The vaccine from lot AS7180B was expired.  BUD was reported as 6/24/2023.   The patient had no adverse reaction.   Treatment information was not reported.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: In the last 2 years patient had a mild case of COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (In the last 2 years patient had a mild case of COVID) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (In the last 2 years patient had a mild case of COVID). At the time of the report, COVID-19 (In the last 2 years patient had a mild case of COVID) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient received 4 Moderna COVID-19 vaccines so far. Patient was going on a cruise on 6 AUG 2023 and was debating getting another dose of the Moderna COVID-19 vaccine. Patient never had any side effects from the vaccine so far but was concerned about that with another dose. in the last 2 years they had had a mild case of COVID.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-734062 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734062:Same Reporter
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination Adverse Reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination Adverse Reaction) in a 47-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced IMMUNISATION REACTION (Vaccination Adverse Reaction). At the time of the report, IMMUNISATION REACTION (Vaccination Adverse Reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.  The Index number was reported as UN-09299.   Reporter did not allow further contact
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 38-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Jun-2023, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 17-Jun-2023, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).    Concomitant and treatment medications were not reported.  Index number was reported as IOM-0255 Company Comment: This is a spontaneous case of Maternal exposure during pregnancy concerns a 38-year-old female patient with no reported medical history, who experienced the non-serious unexpected, event of no adverse event, after a dose of mRNA-1273 Bivalent .222 (Original and Omicron BA.4/BA.5) vaccine. The event was considered unrelated to the vaccine. The benefit-risk relationship of mRNA-1273 Bivalent .222 (Original and Omicron BA.4/BA.5) vaccine is not affected by this report.   Reporter did not allow further contact