chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose: 15-JAN-2022; 2nd dose: 21-APR-2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th January 2022).   On 21-APR-2023, the patient received the 2nd dose of Shingrix. On 21-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose: 15-JAN-2022; 2nd dose: 21-APR-2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 27-APR-2023 The reporter did not consent to follow up. For 1st dose of Shingrix, details were reported. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, Injection site pain, Injection site rash
Clinical narrative: Am soreness around injection site; Rash around injection site; Got a dose that was 6 months expired; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult female patient who received HBV (Engerix B) (expiry date NOV-2022) for prophylaxis.   In APR-2023, the patient received Engerix B. In APR-2023, an unknown time after receiving Engerix B, the patient experienced injection site pain (Verbatim: Am soreness around injection site), injection site rash (Verbatim: Rash around injection site) and expired vaccine used (Verbatim: Got a dose that was 6 months expired). The outcome of the injection site pain, injection site rash and expired vaccine used were unknown.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Engerix B.     It was unknown if the company considered the injection site pain and injection site rash to be related to Engerix B.   Additional Information: GSK Receipt Date: 27-APR-2023 The physician reported that he was notified by staff that a female patient was administered a dose of hepatitis B (physician believes it was Engerix-B) vaccine that was 6 months past expiration. The dose was administered about a week to 10 days ago, and had a November 2022 expiration date. The patient is in her 20s, and reported arm soreness and rash around injection site. The physician did not have any further patient or product information. The reporter consented to follow up. The patient was administered a dose of Engerix-B vaccine that was 6 months past expiration which led to expired vaccine used.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Muscular weakness
Clinical narrative: Lost muscle function; Fell; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 2nd dose of Shingrix. In NOV-2022, less than a day after receiving Shingrix, the patient experienced muscle weakness (Verbatim: Lost muscle function) and fall (Verbatim: Fell). The outcome of the muscle weakness and fall were resolved.   It was unknown if the reporter considered the muscle weakness and fall to be related to Shingrix.     It was unknown if the company considered the muscle weakness and fall to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-APR-2023 The patient received shot and on the same day she lost muscle function and fell. The event lasted minutes and recovered. No other information provided. The reporter consented to follow up. This case is linked with US2023062750, for the same reporter.; Sender's Comments:  US-GSK-US2023062750:Same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Muscular weakness
Clinical narrative: Lost muscle function; Fell; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 2nd dose of Shingrix. In NOV-2022, less than a day after receiving Shingrix, the patient experienced muscle weakness (Verbatim: Lost muscle function) and fall (Verbatim: Fell). The outcome of the muscle weakness and fall were resolved.   It was unknown if the reporter considered the muscle weakness and fall to be related to Shingrix.     It was unknown if the company considered the muscle weakness and fall to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-APR-2023 The patient received 2nd dose of Shingrix and on the same day he lost muscle function and fell. The event lasted minutes and recovered.  No other information provided.  The reporter consented to follow up. This case had been linked with US2023062498, reported by same reporter.; Sender's Comments:  US-GSK-US2023062498:Same reporter.
Age: 19.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 1st dose 2003, 2nd Aug2022. 3rd 07Apr2023; 19YO received adult dose; 19YO received adult dose; 1st dose 2003, 2nd Aug2022. 3rd 07Apr2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old male patient who received HBV (Engerix B pediatric) (batch number P49X7, expiry date 07-DEC-2023) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B pediatric (received a pediatric dose of Engerix-B in 2003).   On 07-APR-2023, the patient received the 3rd dose of Engerix B pediatric. In AUG-2022, the patient received the 2nd dose of Engerix B adult. In AUG-2022, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: 19YO received adult dose), adult product administered to child (Verbatim: 19YO received adult dose) and drug dose administration interval too long (Verbatim: 1st dose 2003, 2nd Aug2022. 3rd 07Apr2023). On 07-APR-2023, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 2003, 2nd Aug2022. 3rd 07Apr2023). The outcome of the overdose, adult product administered to child, drug dose administration interval too long and drug dose administration interval too long were unknown.   Additional Information: GSK receipt date: 28-Apr-2023 The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up, did not had email address to provide.  A pediatric patient received an adult dose of Engerix-B (2nd dose) and a pediatric dose of Engerix-B (3rd dose) later than the recommended interval, which led to overdose, adult product administered by child and drug dose administration interval too long.
Age: 19.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Incomplete course of vaccination, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 1st dose 15Feb2023, 2nd not yet; 19 YO received adult dose; 19 YO received adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old male patient who received HBV (Engerix B adult) (batch number F73DG, expiry date 03-JUL-2023) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis.   On 15-FEB-2023, the patient received the 1st dose of Engerix B adult. On an unknown date, the patient did not receive the 2nd dose of Engerix B adult. On 15-FEB-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: 19 YO received adult dose) and adult product administered to child (Verbatim: 19 YO received adult dose). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 15Feb2023, 2nd not yet). The outcome of the overdose, adult product administered to child and incomplete course of vaccination were unknown.   Additional Information: GSK receipt date: 28-Apr-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The pediatric patient received an adult dose of Engerix-B (first dose), which led to overdose and adult product administered to child. Till the time of reporting the patient did not receive second dose of Engerix-B, which led to incomplete course of vaccination.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: reconstituted with sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number D9ZH7) for prophylaxis.   On 27-APR-2023, the patient received Shingrix. On 27-APR-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 28-APR-2023 The Shingrix was reconstituted using sterile water and administered to a patient. The Vaccine Administration Facility was the same as Primary Reporter. No expiration date was reported. The reporter consented to follow up via email. The Shingrix was reconstituted using sterile water and administered to a patient, which led to wrong solution used in drug reconstitution.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Lip erythema, Oral discomfort, Vaccination failure
Clinical narrative: Had shots 3 years ago, got shingles; Still get shingles; little red dots above upper lip; Lightening sensation through lip; This serious case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On an unknown date, the patient received Shingrix. On 29-APR-2023, an unknown time after receiving Shingrix, the patient experienced lip discomfort (Verbatim: Lightening sensation through lip). On an unknown date, the patient experienced vaccination failure (Verbatim: Had shots 3 years ago, got shingles) (serious criteria GSK medically significant), shingles (Verbatim: Still get shingles) and lip redness (Verbatim: little red dots above upper lip). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the lip redness was not resolved and the outcome of the lip discomfort was resolved.   It was unknown if the reporter considered the vaccination failure, shingles, lip redness and lip discomfort to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles, lip redness and lip discomfort to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-Apr-2023 The patient had her shots about three years ago, could she still get shingles. She had been a Type 1 Diabetic for 55 years, she asked if that makes a difference. The reporter said the product was Shingrix. The patient had her full vaccination of Shingrix about 3-4 years ago, Saturday night, the patient experienced a sensation on her lip as if a piece of lightening was going through her lip.   Then a bunch of little red dots appeared above her upper lip. At the time of the call, the lightening sensation was gone, but the red dots still remain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness around the eye; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of erythema periorbital in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number T5T79, expiry date 24-NOV-2023) for prophylaxis.   On 12-JAN-2023, the patient received the 1st dose of Shingrix (left deltoid). In JAN-2023, 2 days after receiving Shingrix, the patient experienced erythema periorbital (Verbatim: Redness around the eye). The outcome of the erythema periorbital was resolved.   It was unknown if the reporter considered the erythema periorbital to be related to Shingrix.     It was unknown if the company considered the erythema periorbital to be related to Shingrix.   Additional Information: GSK Receipt Date:1-May-2023  The reporter was a pharmacist.   The reporter reported a patient experienced redness around the eye about 2 days after receiving the first dose of Shingrix.   The redness lasted about 2-3 days. Adverse event was filed The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Energy increased, Euphoric mood
Clinical narrative: Some reaction, feeling euphoric; High amount of energy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of euphoric in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 5YR3P, expiry date 07-JUN-2024) for prophylaxis.  On 07-FEB-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced euphoric (Verbatim: Some reaction, feeling euphoric) and energy increased (Verbatim: High amount of energy). The outcome of the euphoric and energy increased were unknown.  It was unknown if the reporter considered the euphoric and energy increased to be related to Shingrix.  It was unknown if the company considered the euphoric and energy increased to be related to Shingrix.  Linked case(s) involving the same patient: US2023063913  Additional Information: GSK Receipt Date: 02-MAY-2023 A pharmacist reported that the patient experienced some reaction after the 1st dose of Shingrix. According to the pharmacist, the patient was feeling euphoric and with high amount of energy after the vaccination. The reporter had consented to follow-up. For tolerance of second dose, refer case US2023063913, reported by same reporter.; Sender's Comments:  US-GSK-US2023063913:Same reporter
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Energy increased, Euphoric mood, Vaccine positive rechallenge
Clinical narrative: Some reaction, feeling euphoric; High amount of energy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of euphoric in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 924E7, expiry date 18-AUG-2024) for prophylaxis.  Previously administered products included Shingrix with an associated reaction of euphoric mood (1st dose was received on 07-FEB-2023 and also she had experienced energy increased, refer case US2023063911).  On 18-APR-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced euphoric (Verbatim: Some reaction, feeling euphoric) and energy increased (Verbatim: High amount of energy). Rechallenge with Shingrix was positive. The outcome of the euphoric and energy increased were unknown.  It was unknown if the reporter considered the euphoric and energy increased to be related to Shingrix.  It was unknown if the company considered the euphoric and energy increased to be related to Shingrix.  Linked case(s) involving the same patient: US2023063911   Additional Information: GSK Receipt Date: 02-MAY-2023 A pharmacist reported that the patient experienced some reaction after the 2nd dose of Shingrix. According to the pharmacist, the patient was feeling euphoric and with high amount of energy after the vaccination. The reporter stated that, same symptoms happened after both the first and second dose. The reporter had consented to follow-up.; Sender's Comments:  US-GSK-US2023063911:Same reporter
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Boostrix 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 32-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775yf, expiry date 22-APR-2023) for prophylaxis.   On 02-MAY-2023, the patient received Boostrix. On 02-MAY-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired Boostrix 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: 02-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. On the day of reporting, the patient received Boostrix that had expired, which led to expired vaccine used.
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with an MMR vaccine diluent; Reconstituted with an MMR vaccine diluent and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 6-month-old male patient who received Hib (Hiberix) (batch number D5B5G, expiry date 24-FEB-2024) for prophylaxis.   On 24-MAR-2023, the patient received Hiberix. On 24-MAR-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with an MMR vaccine diluent) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with an MMR vaccine diluent and administered to patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAY-2023 The reporter reported that the patient received Hiberix vaccine which was reconstituted with an MMR vaccine diluent. The vaccine administration facility was the same as primary reporter. At the time of reporting no more information was provided about the diluent used in reconstitution of vaccine. The reporter did consent to follow up via email. The reporter gave Hiberix vaccine with an MMR vaccine diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered This case had been linked with US2023063928 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023063928:Same reporter/Other patient
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Hiberix non approved diluent/reconstituted with an MMR vaccine diluent; Hiberix non approved diluent/reconstituted with an MMR vaccine diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 2-month-old male patient who received Hib (Hiberix) (batch number D5B5G, expiry date 24-FEB-2024) for prophylaxis.   On 27-MAR-2023, the patient received Hiberix. On 27-MAR-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Hiberix non approved diluent/reconstituted with an MMR vaccine diluent) and inappropriate dose of vaccine administered (Verbatim: Hiberix non approved diluent/reconstituted with an MMR vaccine diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAY-2023 The reporter reported that the patient received Hiberix vaccine which was reconstituted with an MMR vaccine diluent. The vaccine administration facility was the same as primary reporter. No more information was provided about the diluent used in reconstitution of vaccine. The reporter consented to follow up via email. The patient received Hiberix vaccine which was reconstituted with an MMR vaccine diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered This case had been linked with US2023063927, reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2023063927:Same reporter/Other patient
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: diluted with a sterile solution; diluted with a sterile solution; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA903A, expiry date 31-JAN-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: diluted with a sterile solution) and inappropriate dose of vaccine administered (Verbatim: diluted with a sterile solution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAY-2023 A reporter reported that a patient received the MenA lyophilized component of Menveo diluted with a sterile solution. The reporter consented to follow up. A reporter reported that a patient received the MenA lyophilized component of Menveo diluted with a sterile solution, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: only 1 vial administered, given with sterile diluent; only 1 vial administered, given with sterile diluent; This non-serious case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 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 solution used in drug reconstitution (Verbatim: only 1 vial administered, given with sterile diluent) and inappropriate dose of vaccine administered (Verbatim: only 1 vial administered, given with sterile diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 02-MAY-2023 The reporter enquired, if only 1 vial of Menveo was inadvertently administered versus mixing the 2 vials of Menveo together prior to administration, what is the next step? Would patient need to be recalled for revaccination? If so, what is the interval between partial doses?  Would only the missing component be administered the next time or the fully reconstituted dose?  The reporter wanted to know when patient could get Menveo readministered. No further information shared in webform for adverse event (AE). Callback placed to HCP and voicemail left requesting callback. The reporter consented to follow up. The patient received Menveo with sterile diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Feel bad; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   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 feeling bad (Verbatim: Feel bad). The outcome of the feeling bad was resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     It was unknown if the company considered the feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-MAY-2023 The case was self reported by the patient. The patient received second dose of Shingrix and simply made her felt bad. The reporter did not elaborate on side effects. The reporter did not consent to follow up.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2 month old baby got Kinrix; Kinrix instead of Infanrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 20-APR-2023, the patient received Kinrix. On 20-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 month old baby got Kinrix) and wrong vaccine administered (Verbatim: Kinrix instead of Infanrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 02-MAY-2023 The mother called on behalf of her 3 month old patient (daughter) who was the consumer.  The mother stated that her pediatrician office contacted her and stated that her patient received Kinrix when the intended vaccine should had been Infanrix.  The reporter consented to follow up.  The patient received Kinrix instead of Infanrix at inappropriate age, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 0.5
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Baby received Bexsero; Bexsero instead of Engerix-B; 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 6-month-old male patient who received Men B NVS (Bexsero) (batch number 9R42C, expiry date 30-JUN-2024) for prophylaxis.   On 25-APR-2023, the patient received Bexsero. On 25-APR-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Baby received Bexsero) and wrong vaccine administered (Verbatim: Bexsero instead of Engerix-B). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 02-MAY-2023 Supervisor reported that a patient received Bexsero instead of a Hapatitis B vaccine Engerix-B. The reporter consented to follow up by email. The patient received Bexsero instead of Engerix-B at inappropriate age, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Sex: U
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Infanrix accidentally given instead of TDaP; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a patient who received DTPa (Infanrix) for prophylaxis.   On 02-MAY-2023, the patient received Infanrix. On 02-MAY-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix accidentally given instead of TDaP). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-MAY-2023 The reporter called to report that Infanrix was accidentally given instead of TDaP and wished to know how to proceed.  They did not provide information about the patient or vaccine.  The reporter did not consent to follow-up. The reporter called to report that Infanrix was accidentally given instead of TDaP, which led to wrong vaccine administered.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose past 2-6 month recommended time; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th June 2022 in an unknown arm).   On 10-FEB-2023, the patient received the 2nd dose of Shingrix (unknown arm). On 10-FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose past 2-6 month recommended time). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 03-MAY-2023 The reporter was the patient and stated that she got her second Shingrix vaccine past the 2 to 6 month recommended time from receiving the first Shingrix vaccine.   The patient did not had any information about the vaccine itself. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 1.0
Sex: M
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 1-year-old male patient who received DTPa (Infanrix) (batch number 23t73, expiry date 30-APR-2023) for prophylaxis.   On 03-MAY-2023, the patient received Infanrix. On 03-MAY-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: 03-MAY-2023 The reporter consented to follow up. The patient received an expired dose of Infanrix vaccine, which led to expired vaccine used.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Weight decreased
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer concerned a 66 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, 1 total was administered on 06-DEC-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 65 years old. No concomitant medications were reported.  On 15-DEC-2021, the patient experienced excruciating back pain which had continued for 2 weeks. On 19-DEC-2021, the paralysis had started with her mouth while patient was at work. The paralysis continued all through the body all the way to her feet. She had been suffering from paralysis since 16 months at the time of reporting. The patient was completely disabled and all her muscles stopped working and she was in the hospital for almost a month from 05-FEB-2022 to 02-MAR-2022. The number of days of hospitalization was 25 days. The patient was unable to speak due to her paralysis, not able to move her lips and she has to take her hands to move her mouth to be able to eat. She had visited lot of doctors and was finally diagnosed with Guillain-Barre Syndrome. The physician stated that the vaccine had caused this syndrome in other patient's as well. The patient was previously working perfectly fine and at the time of reporting she was not able to walk or drive and was completely disabled.  The patient was able to take immunoglobulins to get her better health which were recommended by her physician. The patient hands were completely curled up and it was hard time typing on a keyboard but she was able to text on the phone. Her body stopped digesting food and the patient lost 41 pounds in 42 days and was not able to walk even with a walker, could only stand using a walker for a small amount of time. She had been visited rehabilitation for 3 times. The patient had been in the wheelchair whole time and initially she was bed bound when the guillain-barre syndrome first started. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from guillain-barre syndrome. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage).; Sender's Comments: V0: 20230505030- Guillain-Barre syndrome. The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received Dose 1 on 04-Sep-2021 and Dose 2 on 05-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 1 on 04-Sep-2021 and Dose 2 on 05-Apr-2022) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 002M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 1 on 04-Sep-2021 and Dose 2 on 05-Apr-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 1 on 04-Sep-2021 and Dose 2 on 05-Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 1 on 04-Sep-2021 and Dose 2 on 05-Apr-2022).    No concomitant medications were reported.  On 04-Sep-2021, the patient received first dose of Moderna COVID-19 Vaccine, Route: Intramuscular with batch/lot number: 037F21A. The dose / volume of first and second dose was reported as 0.5.  Treatment information was not provided.   This case was linked to MOD-2023-722198 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 25-Apr-2023; No adverse event; Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD), PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 25-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 25-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 25-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD), PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 25-Apr-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD) and PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 25-Apr-2023).    No concomitant medications were reported.  No adverse event was reported and a dose of the Moderna vaccine was given to the patient beyond the use by date of 13-Apr-2023.  The dose details of the fourth dose of Moderna vaccine was reported as 0.5.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (Linked Report). This case was linked to MOD-2023-722205 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:Master case
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient received first dose on 17-Feb-2021 and second dose on 13-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 17-Feb-2021 and second dose on 13-Feb-2022) and NO ADVERSE EVENT (No adverse event) in an 81-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 13-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 17-Feb-2021 and second dose on 13-Feb-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 17-Feb-2021 and second dose on 13-Feb-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 17-Feb-2021 and second dose on 13-Feb-2022).    It was unknown that the patient ever been diagnosed with or tested positive for COVID-19.   Concomitant medication information was not provided.  On 17-Feb-2021, the patient received first dose of Moderna COVID-19 vaccine, Intramuscular route with batch lot number: 010M20A.    The dose details of first and second dose was reported as 0.5.  Treatment information was not reported.   This case was linked to MOD-2023-722262 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: Burn ache; Joint pain; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Burn ache), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 028L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension and Seasonal allergy. Concomitant products included MONTELUKAST SODIUM, LOSARTAN and NEBIVOLOL for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Burn ache), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Burn ache), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 17-Nov-2021, the patient received third dose of Pfizer (3rd Dose) and LOT was FH8027.   On 08-Oct-2022, received fourth dose of Pfizer and LOT was GH9703.  On 29- Apr-2023, Patient had pfizer (5th Dose) and LOT was 6L2042. It was reported that Patient (Nurse) got sick from Saturday night all day yesterday, she was almost back to normal today. When paraphrased the concerned consumer stated, I am working but felt better. She was just not 100% yet. When paraphrased that consumer had fever and chills. Consumer stated, yes, burn ache and joint pain.  Patient further stated she got these reaction every time, every time she had COVID Vaccine she gotten sick.  Anatomical Location was left deltoid.  Patient took one tylenol on saturday night.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2023: Follow-up received contains no new information.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Injection site pain, Pain
Clinical narrative: PATIENT STATES HE HAD SHOULDER PAIN PRIOR TO RECEIVING THE MODERNA VACCINE ON 7/29/22 BUT THE VACCINE MADE HIS PAIN WORSE. HE NOW STATES HE HAS PAIN THAT RADIATES FROM THE RIGHT SHOULDER DOWN THROUGH HIS ELBOW TO THE BACK OF HIS FOREARM. PATIENT DOES HAVE ARTHRITIS AND WAS RECEIVING INFLECTRA INFUSIONS PRIOR TO VACCINE DOSE (HE BELIEVES THE LAST DOSE OF THAT WAS IN MAY OR JUNE OF 2022)
Age: 40.0
Sex: M
Vaccine: FLUC4, TD
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: decreased mobility in left upper arm and some pain
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Cough, Diarrhoea, Electrocardiogram abnormal
Clinical narrative: Summer of 2022, I got sick that started with a cold.  I tested negative for COVID-19.  I had a cough.  The doctor prescribed albuterol and a cough suppressant. The cough was so bad I was unable to control it.  I began to feel better for several days but then tested positive for COVID-19.  My symptoms were cough, nausea, vomiting, itchy skin, diarrhea and the head cold symptoms.  I still have the cough today.  I have had several chest X-Rays.  I got my 4th dose in October 2022.  I had an EKG in January and wore a heart monitor for two weeks.  I am scheduled for an echo cardiogram and a pulmonary lung function test.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory abnormal, Malaise, Nasopharyngitis, Nausea, Pruritus
Clinical narrative: Summer of 2022, I got sick that started with a cold.  I tested negative for COVID-19.  I had a cough.  The doctor prescribed albuterol and a cough suppressant. The cough was so bad I was unable to control it.  I began to feel better for several days but then tested positive for COVID-19.  My symptoms were cough, nausea, vomiting, itchy skin, diarrhea and the head cold symptoms.  I still have the cough today.  I have had several chest X-Rays.  I got my 4th dose in October 2022.  I had an EKG in January and wore a heart monitor for two weeks.  I am scheduled for an echo cardiogram and a pulmonary lung function test.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: Summer of 2022, I got sick that started with a cold.  I tested negative for COVID-19.  I had a cough.  The doctor prescribed albuterol and a cough suppressant. The cough was so bad I was unable to control it.  I began to feel better for several days but then tested positive for COVID-19.  My symptoms were cough, nausea, vomiting, itchy skin, diarrhea and the head cold symptoms.  I still have the cough today.  I have had several chest X-Rays.  I got my 4th dose in October 2022.  I had an EKG in January and wore a heart monitor for two weeks.  I am scheduled for an echo cardiogram and a pulmonary lung function test.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: The client came into our clinic for a bivalent booster, we checked his vaccine card and age, based on his age and the amount of time since the last covid vaccine (10/2022) on his card we administered a dose. When staff was later entering this vaccine into the system, it was found that he had received a bivalent vaccine in 01/2023 at another facility which was not noted on his vaccine card.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Started out with a typical rash on right arm from injection.  Then the patient experienced itching on the back at work and all this evening and then noticed she had multiple vesicles spread on the entire back.
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 6 month infant received Moderna COVID Bivalent 6m-5yr pink cap/yellow  border as a first dose.  No side effects noted by parents.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient was given expired vaccine and also waited for the 15 minute mark. No side effects were noted and provider did call the patient and she stated she was fine.
Age: 23.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Dizziness, Dyspnoea, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: Postural tachycardia syndrome - onset 2 weeks post vaccination Chest pain, shortness of breath, dizziness, syncope.