chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles/ suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-Mar-2024 This case was reported by the consumer via interactive digital media. The consumer stated that he/she knew the people who got shingles after receiving the vaccine and that was scares the consumer. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Milder shingles after vaccination/Suspected vaccination failure; Milder shingles; Indescribable pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Milder shingles after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Milder shingles) and pain (Verbatim: Indescribable pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that it was an indescribable pain. The patient went to the emergency room in the middle of the night.  They had no clue. The patient had no outward signs. The patient thought because he/she had taken the vaccine. If what the patient had was a milder case, he/she could imagine the suffering of others. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Itched worse than poison ivy; Severe rash on whole body; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of generalized rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced generalized rash (Verbatim: Severe rash on whole body) and pruritus (Verbatim: Itched worse than poison ivy). The outcome of the generalized rash was resolved (duration 1 year) and the outcome of the pruritus was not reported.   It was unknown if the reporter considered the generalized rash and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the generalized rash and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that Shingles vaccine caused severe rash lasted a year, whole body. Itched worse than poison ivy.  Then patient's daughter caught shingles shortly after fiance was vaccinated, even though she was much younger. The patient asked to stop pushing this poison.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: awful reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feels awful (Verbatim: awful reaction). The outcome of the feels awful was not reported.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.     It was unknown if the company considered the feels awful to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that watch out for that vaccine. Further patient said that he/she had one vaccine and had an awful reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: was real sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: was real sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2024 This case was reported by a patient via interactive digital media. The patient reported that the insurance was not paying but now (at the time of reporting) they were. The patient received his/her 1st dose and was real sick, worth it though with getting his/her 2nd shot in two months.
Sex: U
Vaccine: VARZOS
Symptoms: Joint swelling, Mobility decreased, Pain
Clinical narrative: joints were swollen; Could not even turn over in bed; felt like someone had beaten up; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swollen joints in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced swollen joints (Verbatim: joints were swollen), mobility decreased (Verbatim: Could not even turn over in bed) and pain (Verbatim: felt like someone had beaten up). The outcome of the swollen joints, mobility decreased and pain were not reported.   It was unknown if the reporter considered the swollen joints, mobility decreased and pain to be related to Shingles vaccine.     It was unknown if the company considered the swollen joints, mobility decreased and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she got the first shot, had no problems. Got the second one and ended up in the emergency room. All the joints were swollen and felt like someone had beaten him/her up. The patient could not even turn over in bed. The follow-up could not be possible as no contact details were available.
Age: 12.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old patient received 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 12-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5h95b, expiry date 16-FEB-2026) for prophylaxis.   On 12-MAR-2024, the patient received Kinrix. On 12-MAR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 12 year old patient received 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: 13-MAR-2024 The reporter reported 12 year old patient received Kinrix (and he aged out of it but they didn't catch it on time) which led to inappropriate age at vaccine.  They wanted to catch him up on Tdap and Polio. The reporter consented to follow up.
Age: 1.0
Sex: U
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: health care provider that gave a 12-month-old Menveo vaccine instead of Measles, Mumps, and Rubella Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 12-month-old patient 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 wrong vaccine administered (Verbatim: health care provider that gave a 12-month-old Menveo vaccine instead of Measles, Mumps, and Rubella Vaccine). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 13-MAR-2024 The reporter had a health care provider asking what happened if Menveo was given subcutaneously instead of intramuscular, the reporter did not knowif this did happened and did not have any information other than the patient being 12 months old. The patient received Menveo vaccine instead of Measles, Mumps, and Rubella Vaccine, the reporter wanted to know if there was information on giving the patient the one vial or the two vial presentation of Menveo, the reporter did not know which one was given.  The Vaccine Administration Facility was the same as Primary Reporter. The patient was given Menveo instead of Measles, Mumps, and Rubella Vaccine,which led to wrong vaccine administered. The reporter did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: A pediatric dose of Engerix-B was administered to a 65-year-old patient; Underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 65-year-old female patient who received HBV (Engerix B pediatric) (batch number FP9JT, expiry date 24-MAR-2025) for prophylaxis.   On 11-MAR-2024, the patient received the 1st dose of Engerix B pediatric. On 11-MAR-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: A pediatric dose of Engerix-B was administered to a 65-year-old patient) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were 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: 13-MAR-2024 The reporter called to inform that a pediatric dose of Engerix-B was administered to a 65 year old patient, which led to Adult use of child product and Underdose. The reporter did not consent to follow up.
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: administered Trumenba vaccine at their office on 11Apr2023, and then at her college she was given Bexsero on 24Oct2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 19-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis.   On 24-OCT-2023, the patient received Bexsero. On 11-APR-2023, the patient received Trumenba. On 24-OCT-2023, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: administered Trumenba vaccine at their office on 11Apr2023, and then at her college she was given Bexsero on 24Oct2023). The outcome of the interchange of vaccine products 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: 13-MAR-2024 Clinical Supervisor reported that the patient was administered Trumenba vaccine at their office and then at her college she was given Bexsero, which led to interchange of vaccine products. At the time of reporting, no additional doses of either product had been administered. The reporter did not have the lot number/expiration date information for Bexsero. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Patient was administered Shingrix instead of the varicella vaccine by accident; This non-serious case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Patient was administered Shingrix instead of the varicella vaccine by accident). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 13-MAR-2024 The reporter reported a patient was administered Shingrix instead of the varicella vaccine by accident which led to Wrong Vaccine Administered. The reporter consented to follow up.
Age: 6.0
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse reported a 6 years was administered boostrix; 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 6-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Nurse reported a 6 years was administered boostrix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt date: 14-MAR-2024 The reporter reported a 6 years was administered Boostrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received Havrix 2nd dose too early; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 65-year-old male patient who received HAV (Havrix) (batch number 2345B, expiry date 02-FEB-2026) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix).   On 12-MAR-2024, the patient received the 2nd dose of Havrix. On 12-MAR-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: received Havrix 2nd dose too early). The outcome of the drug dose administration interval too short 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: 14-MAR-2024 Nurse reported that the patient received Havrix 2nd dose too early, which led to drug dose administration interval too short. First dose was administered on 07-Feb-2024. This case had been linked with US2024033699, reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024033699:Diff. patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she has not received the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix in December 2020).   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). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-MAR-2024 The patient self reported this case for herself. The patient reported that she had received her 1st dose of Shingrix vaccine in December 2020.  The patient stated that she had not received the 2nd dose which led to incomplete course of vaccination. The patient inquired if she need to start the 1st dose again.  The patient did not stated the reason why she had not received the 2nd dose.  No additional information was provided. Not all information was available.  The reporter did not consented to follow up.
Sex: M
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: Rotarix liquid presentation administration of expired vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received Rota (Rotarix liquid formulation) (batch number 9742M, expiry date 25-FEB-2024) for prophylaxis.   On 13-MAR-2024, the patient received Rotarix liquid formulation. On 13-MAR-2024, an unknown time after receiving Rotarix liquid formulation, the patient experienced expired vaccine used (Verbatim: Rotarix liquid presentation administration of expired vaccine). 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: 14-MAR-2024 The medical assistant reported that a Rotarix (liquid) vaccine was administered to a 4 month old patient, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to the follow up.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 29-year-old male patient who received HBV (Engerix B) (batch number 9255P, expiry date 15-FEB-2024) for prophylaxis.   On 14-MAR-2024, the patient received the 1st dose of Engerix B. On 14-MAR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Product Used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-MAR-2024 Pharmacy manager reported that the patient was administered a dose of Engerix-B which had an expiration date 15-FEB-2024, which led to expired vaccine used. This was the patient's first dose in the series. At the time of reporting, the dose has not been repeated. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient that got his first dose of the Shingrix vaccine on December 2018; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of shingrix in December 2018).   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 incomplete course of vaccination (Verbatim: a patient that got his first dose of the Shingrix vaccine on December 2018). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-MAR-2024  The pharmacist reported the patient had received his first dose and wants to know did they need to repeat the full series for shingrix or could have only the second dose. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consented to follow up.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertent administration of Kinrix in a patient under 4 years of age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 34-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 15-MAR-2024, the patient received Kinrix. On 15-MAR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertent administration of Kinrix in a patient under 4 years of age). 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: 14-MAR-2024 A medical assistant called in to request information about the inadvertent administration of Kinrix.  They provided data about vaccines, event and patient. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 0.83
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to a 10 month old; 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 10-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) 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: Kinrix was administered to a 10 month old). 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: 15-MAR-2024 The physician reported a dose of Kinrix was administered to a 10 month old which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient had first dose in may 2018 and second dose in Oct 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had received 1st dose of shingrix in May 2018).   In OCT-2023, the patient received the 2nd dose of Shingrix. In OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Patient had first dose in may 2018 and second dose in Oct 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 18-MAR-2024 The reporter wanted to know that if we can consider it as series was completed or we need to administer another dose. The reporter did not provided any contact details, lot number, expiration date or patients detail. The reporter reported that the patient had received 2 doses of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 19 month old child was given Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) 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: 19 month old child was given Kinrix). 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: 19-MAR-2024 The medical assistant reported a 19 month old child was given Kinrix which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received their 2nd dose of Engerix-B late; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included ENGERIX-B (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: patient received their 2nd dose of Engerix-B late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 19-MAR-2024 Medical assistant reports a patient who received 2nd dose of Engirix-B late 6 months after 1st dose, which led to lengthening of vaccination schedule. Medical assistant had no further information on product or patient. The reporter declined consent for follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received Herpes zoster (Shingrix) (expiry date 09-FEB-2024) for prophylaxis.   On 04-MAR-2024, the patient received the 2nd dose of Shingrix (left deltoid). On 04-MAR-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 19-MAR-2024 The pharmacist reported that an expired vaccine was given to a patient, which led to expired vaccine used. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 1st dose on 2020 and then got 2nd dose on 18 March 2024; 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 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 3ZT24, expiry date 21-APR-2026) and (batch number 2TJ49, expiry date 21-APR-2026) for prophylaxis.   Previously administered products included Shingrix (on 2020 received 1st dose).   On 18-MAR-2024, the patient received the 2nd dose of Shingrix. On 18-MAR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received 1st dose on 2020 and then got 2nd dose on 18 March 2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 19-MAR-2024 The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE, no PQC; Product storage error; This spontaneous report was received from nurse practitioner, concerning a 3-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 18-OCT-2023, the patient was vaccinated with an out of temperature range of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (lot #W031980, has been verified to be valid, expiration date reported as 22-AUG-2024, but upon internal validation established as 06-OCT-2024)  (albumin status: recombinant human albumin) administered subcutaneously for prophylaxis (strength was not provided). The patient was vaccinated at public health clinic/hospital, purchased with public funds. No adverse event reported.   It was a single use vaccine, the operator of device was a healthcare professional, who was trained. The vaccine was not available for return/or evaluation.  The event was previously reported to manufacturer. The current location of vaccine was reported as used up/storage. The temperature excursion occur as a result of reading from a Digital Data Logger. The medication error occurred during storage in clinical practice.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005577: US-009507513-2403USA005241: US-009507513-2403USA005579:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: No additional AE, no PQC; Product storage error; This spontaneous report was received from nurse practitioner, concerning a 4-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 23-OCT-2023, the patient was vaccinated with an out of temperature range of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (lot #W031980, has been verified to be valid, expiration date reported as 22-AUG-2024, but upon internal validation established as 06-OCT-2024)  (albumin status: recombinant human albumin) administered subcutaneously for prophylaxis (strength was not provided). The patient was vaccinated at public health clinic/hospital, purchased with public funds. No adverse event reported.   It was a single use vaccine, the operator of device was a healthcare professional, who was trained. The vaccine was not available for return/or evaluation.  The event was previously reported to manufacturer. The current location of vaccine was reported as used up/storage. The temperature excursion occur as a result of reading from a Digital Data Logger. The medication error occurred during storage in clinical practice.  This is one of the several cases created from the same source.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005578: US-009507513-2403USA005577: US-009507513-2403USA005578: US-009507513-2403USA005241:
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: had a Twinrix shot a long time ago and wants to receive the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received on an unknown date).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: had a Twinrix shot a long time ago and wants to receive the second dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-MAR-2024 The patient received inappropriate schedule of Twinrix. The patient received Twinrix a long time ago and wanted to get the second dose. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up granted.
Sex: M
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: GENERAL INJURY; This spontaneous report received from a patient via social media and it was unknown if it was a J&J managed social media site concerned a male of unspecified age. 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. No concomitant medications were reported. On an unspecified date, the patient experienced general injury (dose series 1), and was hospitalized (date unspecified). It was reported that imagine being injured by the covid vaccine, but they has zero accountability for it. Patient's kids had to watch their dad being taken to the hospital by ambulance. We thought he was going to die. Very expensive and damaging and not funny. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of general injury was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-Injury. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product, No adverse event, Syringe issue
Clinical narrative: The plunger in it sometimes so hard to get out and had to pull hard, a little of the vaccine got in my face and eye; The plunger in it  sometimes so hard to get out and had to pull hard, a little of the vaccine got in my face and eye; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of SYRINGE ISSUE (The plunger in it sometimes so hard to get out and had to pull hard, a little of the vaccine got in my face and eye), ACCIDENTAL EXPOSURE TO PRODUCT (The plunger in it  sometimes so hard to get out and had to pull hard, a little of the vaccine got in my face and eye) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced SYRINGE ISSUE (The plunger in it sometimes so hard to get out and had to pull hard, a little of the vaccine got in my face and eye), ACCIDENTAL EXPOSURE TO PRODUCT (The plunger in it  sometimes so hard to get out and had to pull hard, a little of the vaccine got in my face and eye) and NO ADVERSE EVENT (No adverse event). At the time of the report, SYRINGE ISSUE (The plunger in it sometimes so hard to get out and had to pull hard, a little of the vaccine got in my face and eye), ACCIDENTAL EXPOSURE TO PRODUCT (The plunger in it  sometimes so hard to get out and had to pull hard, a little of the vaccine got in my face and eye) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   No concomitant medication was reported.  The person works in a pharmacy and was getting a Spikevax prepared. The plunger in it would sometimes so hard to get out, and had to pull hard, a little of the vaccine got in face and eye. They washed it out immediately.   The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2024: Live Significant follow up received. Reference number added.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Poor quality product administered, Product container issue, Product preparation issue
Clinical narrative: It ran down to the side/ There is a little crack and the diluent spilled; Unsuccessful reconstitution of the Abrysvo vaccine; It ran down to the side/ There is a little crack and the diluent spilled; This is a spontaneous report received from a Pharmacist, Program ID.  A 69-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 19Mar2024 as dose number unknown, 0.5 ml single (Lot number: HM7677, Expiration Date: Mar2025) at the age of 69 years intramuscular, in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), DEVICE BREAKAGE (non-serious) and all described as "It ran down to the side/ There is a little crack and the diluent spilled"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), described as "Unsuccessful reconstitution of the Abrysvo vaccine".  Additional information: the pharmacist mentioned when she drew up and mixed the diluent of the vaccine into the vial, it ran down to the side. When she checked, when she took a look on the vial, there is a little crack and the diluent spilled. the pharmacist mentioned when she drew up and mixed the diluent of the vaccine into the vial, it ran down to the side. When she checked, when she took a look on the vial, there is a little crack and the diluent spilled. The wife was not able to get her vaccine today, and the Pharmacist is looking to get a replacement for the unsuccessful reconstitution of the Abrysvo vaccine.  Causality for "it ran down to the side/ there is a little crack and the diluent spilled" and "unsuccessful reconstitution of the abrysvo vaccine" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vertigo
Clinical narrative: vertigo; this is her 7th dose of of the Pfizer COVID Vaccine (Comirnaty); This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 88-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 88 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1-6), for COVID-19 immunisation. The following information was reported: VERTIGO (non-serious), outcome "unknown"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "this is her 7th dose of of the Pfizer COVID Vaccine (Comirnaty)".  Additional information: Patient called in and stated that she has had 7 Pfizer Covid 19 vaccine shots. She took the last one on 15Nov2023. She stated she had vertigo after the last shot and it lasted for weeks and it was "very unpleasant""/ unpleasant vertigo that lasted for weeks and as well as this is her 7th dose of the Pfizer COVID Vaccine (Comirnaty). Patient asked if she will get vertigo on her next dose of the Pfizer Covid vaccine. Consumer stated, "You can give me some information. I had the last shot (COVID vaccine) four months ago and I got very unpleasant vertigo. Consumer stated, "I would like to get the information. I am trying to find out I got quite a bad case of vertigo, the last one of the shots that I had, lasted quite a while. I was wondering is it more likely that I will get vertigo again if I have the next shot?" The last one Pfizer, I am having a hard time. It looks like "H64675", that's what it looks like. The guy's writing is not very clear. All it says it's Pfizer (COVID vaccine)." "Yes. It's Pfizer COVID vaccine, vaccination record card."   Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had a case of COVID, my first; tested positive; ran a temp of 103 for a few days and the whole course lasted about two weeks; I had a case of COVID, my first; tested positive; ran a temp of 103 for a few days and the whole course lasted about two weeks; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 75-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (PRIMARY IMMUNIZATION SERIES COMPLETE), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), Lot number: Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Jan2024, outcome "unknown" and all described as "I had a case of COVID, my first; tested positive; ran a temp of 103 for a few days and the whole course lasted about two weeks". The patient underwent the following laboratory tests and procedures: Body temperature: (2024) 103, notes: ran a temp of 103 for a few days; SARS-CoV-2 test: (29Jan2024) Positive.  Clinical course: The reporter stated that "I was up to date on all vaccines (all Pfizer) but then I had a case of COVID, my first. I tested positive on 29Jan2024, ran a temp (temperature) of 103 for a few days and the whole course lasted about two weeks. My question is how long should I wait before my next vaccine. I am male, aged 75 in pretty good physical shape for my age" The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Cerebrovascular accident, Computerised tomogram, Diplopia, Magnetic resonance imaging, Spinal operation
Clinical narrative: stroke; double vision; back surgery; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 13:00 as dose 1, single (batch/lot number: HG5428) at the age of 68 years, in right arm for covid-19 immunization; influenza vaccine inact split 4v (QUADRIVALENT INFLUENZA VACCINE), on 26Sep2023 as dose 1, single), in left arm for immunization. The patient informed that the facility type vaccine was pharmacy or drug store. The patient's relevant medical history included: "HIV" (unspecified if ongoing); "silent heart attack" (unspecified if ongoing); "multiple back surgeries" (unspecified if ongoing); "chronic sinus infection" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior vaccination. Concomitant medications included: CLINDAMYCIN. Past drug history included: Effexor, reactions: "allergies". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: SPINAL OPERATION (hospitalization) with onset 20Oct2023 at 08:00, outcome "recovered", described as "back surgery"; DIPLOPIA (hospitalization) with onset 20Nov2023, outcome "recovered" (Nov2023), described as "double vision"; CEREBROVASCULAR ACCIDENT (hospitalization) with onset 20Nov2023, outcome "recovered", described as "stroke". The patient was hospitalized for spinal operation (start date: 17Nov2023, discharge date: 19Nov2023, hospitalization duration: 3 days); for cerebrovascular accident, diplopia (start date: 20Nov2023, discharge date: 22Nov2023, hospitalization duration: 3 days). The events "back surgery" and "stroke" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: CAT: confirmed stroke; MRI: confirmed stroke. Therapeutic measures were taken as a result of spinal operation, cerebrovascular accident, diplopia which included stroke protocol; Plavix for 21 days, other prescription "chan". Clinical course: The patient informed that the patient was discharged from hospital 19Nov2023 after back surgery and the next day (20Nov2023), the patient woke up with double vision. The patient went to ER and was admitted for a stroke. The double vision cleared up in a couple days (Nov2023). The MRI and CAT scans confirmed stroke. The neurologist said it was a tiny spot like a period at the end of a sentence. The patient has no other symptoms.