chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old received Fluarix QIV; 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 4-month-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced inappropriate age at vaccine administration (Verbatim: 4 month old received Fluarix QIV).  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: 04-OCT-2023 The reporter reported the administration of Fluarix QIV to a 4 month old patient which led to inappropriate age at vaccine administration. The Healthcare professional asked for expected side effects and safety information regarding the situation. The reporter did not provide patient information (gender, patient initials) nor information regarding the Fluarix QIV dose given (lot number expiration date). The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: headache; This non-serious case was reported by a other health professional via sales rep and described the occurrence of headache in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, immediately after receiving Menveo, the patient experienced headache (Verbatim: headache). The outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Menveo.     It was unknown if the company considered the headache to be related to Menveo.   Additional Information: GSK Receipt Date: 04-OCT-2023 The health care professional reported shortly after getting Menveo vaccine patient experienced headache. No other information was available. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong technique in product usage process
Clinical narrative: had to poke the patient twice when administering; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in drug usage process in a 58-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) (batch number XY5Z2) for prophylaxis.   On 04-OCT-2023, the patient received the 1st dose of Fluarix Tetra 2023-2024 season (intramuscular). On 04-OCT-2023, an unknown time after receiving Fluarix Tetra 2023-2024 season, the patient experienced wrong technique in drug usage process (Verbatim: had to poke the patient twice when administering).  The outcome of the wrong technique in drug usage process 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: 04-OCT-2023 A pharmacist reported that they had to poke the patient twice when administering the GSK injectable medication which led to Wrong technique in drug usage process. The reporter Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: administered first dose in 2018 and physician do not have record of second 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 elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient administered first dose in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: administered first dose in 2018 and physician do not have record of second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2023 The reporter was calling on behalf of her elderly mother. The reporter could not find verification that mother received her 2nd dose of Shingrix. Pharmacy that administered first dose in 2018 and physician did not have record of second dose. No further information was available. The reporter did not consent to follow-up. The reporter was not in agreement with filing a safety report about her mother's experience with the vaccine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2019187002:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient had waited 13 months between both doses; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th September 2022 with batch number LG2XJ).   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 waited 13 months between both doses). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 04-OCT-2023 A physician called in to request information about the administration of the second dose of Shingrix after a patient had waited 13 months between both doses.  Partial information was given, as well as consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: received the vaccines which were exposed to below freezing temperatures; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   On 03-OCT-2023, the patients received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: received the vaccines which were exposed to below freezing temperatures).  The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 04-OCT-2023 Nurse states that Flulaval was exposed to 29F for 3 hours and was then administered to some patients yesterday, 03 October 2023. The patients received a dose of Flulaval QIV after exposed to 29F, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered just the liquid portion of Shingrix without prior reconstitution; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-OCT-2023, the patient received Shingrix. On 04-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered just the liquid portion of Shingrix without prior reconstitution) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-OCT-2023 The nurse reported that heath care provider from the clinic administered just the liquid portion of Shingrix without prior reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up. No patient information available. No lot number or expiration date for the vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Gait inability
Clinical narrative: Lower back pain; could not walk; This non-serious case was reported by a consumer via call center representative and described the occurrence of low back pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included osteoporosis. Concomitant products included pitavastatin calcium (Livalo) and risedronate.   In JAN-2023, the patient received the 1st dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced low back pain (Verbatim: Lower back pain) and unable to walk (Verbatim: could not walk).  The patient was treated with non-drug therapy (Physical Therapy). The outcome of the low back pain was not resolved and the outcome of the unable to walk was resolved.   It was unknown if the reporter considered the low back pain and unable to walk to be related to Shingrix.     It was unknown if the company considered the low back pain and unable to walk to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR138069   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter reported that the patient received Shingrix vaccine and within 3 weeks of receiving the vaccine she experienced lower back pain and could not walk and after going to physical therapy, it got better in April 2023. The reporter stated that although she can still feel it if she was not cautious. Patient had no further information available about this vaccine, no lot number, expiry date route of administration, or location of administration. This US2023AMR138069 case has been linked to the case reported by the same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR138069:same patient, 2nd dose US-GSK-US2023AMR138069:same patient, 1st dose
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Epistaxis
Clinical narrative: nosebleed/she experienced a nosebleed; This non-serious case was reported by a consumer via call center representative and described the occurrence of epistaxis in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 04-OCT-2023, the patient received Arexvy (right arm). On 05-OCT-2023, 1 days after receiving Arexvy, the patient experienced epistaxis (Verbatim: nosebleed/she experienced a nosebleed).  The outcome of the epistaxis was unknown.   It was unknown if the reporter considered the epistaxis to be related to Arexvy.     It was unknown if the company considered the epistaxis to be related to Arexvy.   Additional Information: GSK receipt date: 05-OCT-2023 and 09-OCT-2023 The patient reported that she received a dose of Arexvy yesterday afternoon and when she woke up to blow her nose today, she experienced a nosebleed. The reporter did not consente to follow up.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 53 years old patient was administered a pediatric dose of Engerix-B; 53 years old patient was administered a pediatric dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 53-year-old male patient who received HBV (Engerix B 10 mcg) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis.   On 04-OCT-2023, the patient received Engerix B 10 mcg. On 04-OCT-2023, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: 53 years old patient was administered a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: 53 years old patient was administered a pediatric dose of Engerix-B).  The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter reported that the 53 years old patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter also notes that she thoughts that the patient may had received hepatitis b series years ago, but he received an alert from his medical chart from PCP's office stating that he was overdue for certain vaccinations, so he came in to request hepatitis b series.  The reporter did not had any information on possible prior hepatitis b series. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: gotten off track with schedule. The patient received first dose on 05Sep2023, and second dose was at day 14 on 19Sep2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 65-year-old female patient who received HAB (Twinrix) (batch number 2PG39, expiry date 19-SEP-2025) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 19-SEP-2023, the patient received the 2nd dose of Twinrix. On 19-SEP-2023, 14 days after receiving Twinrix and an unknown time after starting Twinrix, the patient experienced drug dose administration interval too short (Verbatim: gotten off track with schedule. The patient received first dose on 05Sep2023, and second dose was at day 14 on 19Sep2023).  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: 05-OCT-2023 The pharmacist had a patient that was going to do Twinrix accelerated dosing schedule, but has gotten off track with schedule.  The patient received 1st dose and 2nd dose was at day.  The patient was now (at the time of reporting) at day 30 and requested for 3rd dose, but has not yet been administered at time of call. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose less than the schedule time, which led to shortening to vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: HEPAB
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 patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 05-OCT-2023, the patient received Twinrix. On 05-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired Product Used).  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: 05-OCT-2023 The reporter reported that the vaccine was administered by someone else and the reporter did not had any patient information at the time of call. The vaccine administration facility was the same as primary reporter. The patient received Twinrix vaccine which was already expired, which led to expired vaccine used. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient in the past choose not to receive the 2nd dose for reasons undisclosed; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, received first dose).   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: patient in the past choose not to receive the 2nd dose for reasons undisclosed).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 05-OCT-2023 The reporter would like any pertinent data on shingles prevention rate after 1st dose of Shingrix. Reporter reported that Shingrix was a 2 dose series but had at least one patient in the past choose not to received the 2nd dose for reason undisclosed. Reporter would like any data supporting possible benefit patients received after 1st dose of Shingrix so he could reply that information to patients in case they ask him about it. The reporter consented to follow up. The reporter reported that till the time of reporting the patient had not received the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received his second dose of SHINGRIX 10 months after his first dose; 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 adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 10 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received his second dose of SHINGRIX 10 months after his first dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 05-OCT-2023 This case was reported by patient's wife. The patient received his second dose of SHINGRIX 10 months after his first dose. 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.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient received a dose that had an expired diluent component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA729A, expiry date 30-SEP-2023) for prophylaxis.   On 05-OCT-2023, the patient received Menveo. On 05-OCT-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient received a dose that had an expired diluent component).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2023 Clinic Manager reported a Medical Assistant pulled a Menveo vaccine and saw that the expiration date was OCT-2023, however when entering she noticed that there was another expiration date of SEP-2023 also listed. Therefore, the patient received a dose that had an expired diluent component, which led to expired vaccine used. The dose was administered to a 16 year old female patient. At the time of reporting, a repeat dose had not been administered. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: injection site was hot to touch; The injection site is swollen; injection site is "lumpy"/lump; shivers; he broke with hives; small red spot; hot to touch; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 05-OCT-2023, 2 days after receiving Shingrix, the patient experienced injection site warmth (Verbatim: injection site was hot to touch), injection site swelling (Verbatim: The injection site is swollen), injection site lump (Verbatim: injection site is "lumpy"/lump), shivering (Verbatim: shivers), hives (Verbatim: he broke with hives), localized erythema (Verbatim: small red spot) and feeling hot (Verbatim: hot to touch).  The outcome of the injection site warmth, injection site swelling, injection site lump, shivering, hives, localized erythema and feeling hot were unknown.   It was unknown if the reporter considered the injection site warmth, injection site swelling, injection site lump, shivering, hives, localized erythema and feeling hot to be related to Shingrix.     It was unknown if the company considered the injection site warmth, injection site swelling, injection site lump, shivering, hives, localized erythema and feeling hot to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter was the spouse of the patient. Customer reported that her husband got the 1st dose of Shingrix vaccine. The vaccine was provided at a local pharmacy. Lot and expiration date were unknown. The reporter stated that it started earlier today with a small red spot, something normal, then the last hour he broke with hives. Reporter stated the hives were in the back, chest, and both arms right down to the elbow. The injection site was lump and was swollen. The patient had shivers and the injection site was hot to touch. The reporter consented to follow up. Not all information was available. The patient provided consent to follow up with pharmacist at the pharmacy facility. Customer did not provide name of the pharmacist. The reporter said that they had 2 pharmacist in this location.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: injection site was hot to touch; The injection site is swollen; injection site is "lumpy"/lump; shivers; he broke with hives; small red spot; hot to touch; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 05-OCT-2023, 2 days after receiving Shingrix, the patient experienced injection site warmth (Verbatim: injection site was hot to touch), injection site swelling (Verbatim: The injection site is swollen), injection site lump (Verbatim: injection site is "lumpy"/lump), shivering (Verbatim: shivers), hives (Verbatim: he broke with hives), localized erythema (Verbatim: small red spot) and feeling hot (Verbatim: hot to touch).  The outcome of the injection site warmth, injection site swelling, injection site lump, shivering, hives, localized erythema and feeling hot were unknown.   It was unknown if the reporter considered the injection site warmth, injection site swelling, injection site lump, shivering, hives, localized erythema and feeling hot to be related to Shingrix.     It was unknown if the company considered the injection site warmth, injection site swelling, injection site lump, shivering, hives, localized erythema and feeling hot to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter was the spouse of the patient. Customer reported that her husband got the 1st dose of Shingrix vaccine. The vaccine was provided at a local pharmacy. Lot and expiration date were unknown. The reporter stated that it started earlier today with a small red spot, something normal, then the last hour he broke with hives. Reporter stated the hives were in the back, chest, and both arms right down to the elbow. The injection site was lump and was swollen. The patient had shivers and the injection site was hot to touch. The reporter consented to follow up. Not all information was available. The patient provided consent to follow up with pharmacist at the pharmacy facility. Customer did not provide name of the pharmacist. The reporter said that they had 2 pharmacist in this location.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Engerix B adult instead of Twinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 67-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced wrong vaccine administered (Verbatim: administered Engerix B adult instead of Twinrix).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2023 The nurse reported that the administration of a pediatric dose of Engerix B instead of Twinrix to a 67 year old patient which led to wrong vaccine administered. The nurse asked for information regarding this situation. Then, the nurse confirmed that the patient received an adult dose of Engerix B but asked for information regarding the use of pediatric Engerix B in adults and mentioned they will continue with HepA vaccination to complete the HepA HepB dose (Twinrix). The nurse did not provide information about the Engerix B dose given (lot number and expiration date) nor patient initials. Permission to follow up was not requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Pain, Skin lesion
Clinical narrative: Late dose two; Shingles like lesions; Pain; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 5592T, expiry date 12-OCT-2023) for prophylaxis.   On 04-OCT-2023, the patient received the 2nd dose of Shingrix (unknown arm). On 27-FEB-2023, the patient received the 1st dose of Shingrix. On 28-FEB-2023, not applicable after receiving Shingrix and 1 days after receiving Shingrix, the patient experienced vesicular rash (Verbatim: Shingles like lesions) and pain (Verbatim: Pain). On 04-OCT-2023, the patient experienced drug dose administration interval too long (Verbatim: Late dose two).  The outcome of the vesicular rash and pain were resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the vesicular rash and pain to be related to Shingrix.     It was unknown if the company considered the vesicular rash and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-OCT-2023 The pharmacist reported that the patient experienced lesions after dose one of Shingrix and received dose two 8 months after dose one. Pharmacist described lesions as shingles like and located on the interior of the arm that received the vaccination. The lesions appeared the day after she received the first dose of Shingrix. The lesions dried like vesicles and completely went away with no residual pain. Lot number and expiration date for dose two of Shingrix were not provided. Pharmacist noted the patient did not experience any reaction on the day after dose two. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The reporter consented to follow up.
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Fluarix + Administration of expired dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 40-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (expiry date 30-JUN-2023) for prophylaxis.   On 05-OCT-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On 05-OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: Fluarix + Administration of expired dose.).  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: 05-OCT-2023 The vaccine administration facility was the same as primary reporter The nurse reported on October 5th 2023 that today (on the day of reporting) an adult patient received a dose of Fluarix expired on June 30th 2023, which led to expired vaccine used. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient forgot about the second dose, so it has not yet been administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on July 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient forgot about the second dose, so it has not yet been administered).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 05-OCT-2023 The pharmacist stated that a patient received their 1st dose of Shingrix. The patient forgot about the 2nd dose, so it has not yet been administered, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received their first dose of Twinrix on 27-JUL-2023 and the second dose of 3-OCT-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 27th July 2023).   On 03-OCT-2023, the patient received the 2nd dose of Twinrix. On 03-OCT-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received their first dose of Twinrix on 27-JUL-2023 and the second dose of 3-OCT-2023).  The outcome of the drug dose administration interval too long 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: 05-OCT-2023 The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: he received the first dose of Shingrix about 5 years ago but never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 years ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: he received the first dose of Shingrix about 5 years ago but never got the second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 6th Oct 2023 A retired pharmacist states that he received the first dose of Shingrix about 5 years ago but never got the second dose. The reporter asked if he needs to restart the series. The reporter did not provide information about the first dose given (lot number, exp date). The reporter consented to follow up. Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: IBS flare up; This spontaneous case was reported by a patient and describes the occurrence of IRRITABLE BOWEL SYNDROME (IBS flare up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IRRITABLE BOWEL SYNDROME (IBS flare up). The patient was treated with VEDOLIZUMAB (ENTYVIO) for Irritable bowel syndrome, at an unspecified dose and frequency. At the time of the report, IRRITABLE BOWEL SYNDROME (IBS flare up) had not resolved.            No concomitant medications were reported.  The patient started treatment with Moderna COVID-19 vaccine on an unreported date in Feb-2021 and Mar-2021, and then summer and then winter 2022/2023, every 6 months for a total of 5 shots with Moderna for COVID-19 immunisation. It was reported the patient had IBS, and a month after each shot, she would flare up. The patient reported that the doctor said lymphocytes are asked to generate antibodies and there is no wonder that's when the flare ups happened. Her gastroenterologist said it was a different cause and she started to flare in the winter of 2021. The individual was on Entyvio for IBS and had her second dose on 19-Sep-2023. The patient reported an IBS flare up comes every 30 days after she stops the steroid. She started to flare 3 days before taking Entyvio.   This case was linked to US-MODERNATX, INC.-MOD-2023-745444, US-MODERNATX, INC.-MOD-2023-745439 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745444:Same Patient. US-MODERNATX, INC.-MOD-2023-745439:Same Patient.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: I remembered being sore last year, but I don't remember it being this bad; This spontaneous case was reported by a patient and describes the occurrence of PAIN (I remembered being sore last year, but I don't remember it being this bad) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concomitant products included LEVOTHYROXINE and CARBAMAZEPINE for an unknown indication.    On 21-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (I remembered being sore last year, but I don't remember it being this bad). The patient was treated with NAPROXEN at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 2 aspirins. At the time of the report, PAIN (I remembered being sore last year, but I don't remember it being this bad) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient received 1st dose of vaccine on 04-Mar-2021, 2nd dose on 01-Apr-2021, 3rd dose on 03-Dec-2021.  Reportedly, the patient was just wondering this year how long people were complaining about being so sore. Patient remembered being sore last year, but didn't remember it being this bad.   This case was linked to US-MODERNATX, INC.-MOD-2023-744957 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration
Clinical narrative: Patient had some redness; induration; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Patient had some redness) and INDURATION (induration) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 006B21A and 048F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Patient had some redness) and INDURATION (induration). At the time of the report, ERYTHEMA (Patient had some redness) and INDURATION (induration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The Doctor received her first Moderna Covid-19 vaccine on February 19, 2021, lot number 024M20A expiration date was not known. Patient had redness and induration went away after 24 to 48 hours.   No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-645549 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-645549:same patient bivalent case
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: IBS flare up; This spontaneous case was reported by a patient and describes the occurrence of IRRITABLE BOWEL SYNDROME (IBS flare up) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 immunisation.     Concurrent medical conditions included Irritable bowel syndrome.   In 2022, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (IBS flare up). The patient was treated with VEDOLIZUMAB (ENTYVIO) for Irritable bowel syndrome, at an unspecified dose and frequency. At the time of the report, IRRITABLE BOWEL SYNDROME (IBS flare up) had not resolved.            No concomitant medications were reported.  The patient started treatment with Moderna COVID-19 vaccine on an unreported date in Feb-2021 and Mar-2021, and then summer and then winter 2022/2023, every 6 months for a total of 5 shots with Moderna for COVID-19 immunisation. It was reported that the patient had irritable bowel syndrome, and a month after each shot, she would flare up.  The patient reported that the physician said lymphocytes were asked to generate antibodies and there was no wonder that's when the flare ups happened. Her gastroenterologist said it was a different cause and she started to flare in the winter of 2021.  The patient was on Entyvio for irritable bowel syndrome. The patient reported an irritable bowel syndrome flare up comes every 30 days after she stops the steroid. She started to flare 3 days before taking Entyvio.   This case was linked to MOD-2023-745444, MOD-2023-744592 (Patient Link).
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Irritable bowel syndrome
Clinical narrative: a month after each shot, she would flare up; This spontaneous case was reported by a patient and describes the occurrence of IRRITABLE BOWEL SYNDROME (a month after each shot, she would flare up) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 immunisation.     Concurrent medical conditions included Irritable bowel syndrome.    In 2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced IRRITABLE BOWEL SYNDROME (a month after each shot, she would flare up). The patient was treated with VEDOLIZUMAB (ENTYVIO) on 19-Sep-2023 for Irritable bowel syndrome, at a dose of UNK (second dose). At the time of the report, IRRITABLE BOWEL SYNDROME (a month after each shot, she would flare up) outcome was unknown.            Patient past Moderna-covid 19 vaccine included COVID-19 vaccine on an unreported date in FEB-2021 and MAR-2021, and then summer and then winter 2022 with unknown batch lot number. The patient reported that the physician said lymphocytes were asked to generate antibodies and there was no wonder that's when the flare ups happened. The patient reported an irritable bowel syndrome flare up comes every 30 days after she stops the steroid. Patient reported that she started to flare 3 days before taking treatment medications.   This case was linked to MOD-2023-744592, MOD-2023-745439 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Migraine, Myalgia, Pain in extremity
Clinical narrative: Sore arm at injection site; shaking; migraine headache; aura; Sore arm at injection site; muscle aches all over; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), MIGRAINE (migraine headache), AURA (aura), INJECTION SITE PAIN (Sore arm at injection site) and MYALGIA (muscle aches all over) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 08-Oct-2023, the patient experienced TREMOR (shaking), MIGRAINE (migraine headache), AURA (aura), INJECTION SITE PAIN (Sore arm at injection site), MYALGIA (muscle aches all over) and CHILLS (chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm at injection site). At the time of the report, TREMOR (shaking), MIGRAINE (migraine headache), AURA (aura), INJECTION SITE PAIN (Sore arm at injection site), MYALGIA (muscle aches all over) and CHILLS (chills) was resolving and PAIN IN EXTREMITY (Sore arm at injection site) outcome was unknown.            Concomitant medication not reported.   Treatment medication not reported.  The patient experienced sore arm at injection site, 8 hours later muscle aches all over, chills, shaking, migraine headache with aura It was unknown if the patient experienced any additional symptoms/events.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Sore arm at injection site; shaking; migraine headache; aura; Sore arm at injection site; muscle aches all over; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), MIGRAINE (migraine headache), AURA (aura), INJECTION SITE PAIN (Sore arm at injection site) and MYALGIA (muscle aches all over) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 08-Oct-2023, the patient experienced TREMOR (shaking), MIGRAINE (migraine headache), AURA (aura), INJECTION SITE PAIN (Sore arm at injection site), MYALGIA (muscle aches all over) and CHILLS (chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm at injection site). At the time of the report, TREMOR (shaking), MIGRAINE (migraine headache), AURA (aura), INJECTION SITE PAIN (Sore arm at injection site), MYALGIA (muscle aches all over) and CHILLS (chills) was resolving and PAIN IN EXTREMITY (Sore arm at injection site) outcome was unknown.            Concomitant medication not reported.   Treatment medication not reported.  The patient experienced sore arm at injection site, 8 hours later muscle aches all over, chills, shaking, migraine headache with aura It was unknown if the patient experienced any additional symptoms/events.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN (sore) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concomitant products included LEVOTHYROXINE and CARBAMAZEPINE for an unknown indication.    On 08-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAIN (sore). The patient was treated with NAPROXEN at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 2 aspirins. At the time of the report, PAIN (sore) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   On 04-Mar-2021, patient received 1st dose. On 01-Apr-2021, patient received 2nd dose. On 03-Dec-2021, patient received 3rd dose. On 21-Nov-2022, patient received 4th dose.  On the day of vaccination, in afternoon and evening, patient did not feel any soreness in the arm nor anywhere else. Next morning, patient was sore, and stated about never being this sore.   This case was linked to US-MODERNATX, INC.-MOD-2023-744962 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744962:Bivalent dose
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Pain in extremity
Clinical narrative: difficulty walking/limping; fatigue/she felt tired; soreness of the arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (difficulty walking/limping), FATIGUE (fatigue/she felt tired), PAIN IN EXTREMITY (soreness of the arm) and CHILLS (chills) in a 31-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031283) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) at an unspecified dose. On 06-Oct-2023, the patient experienced GAIT DISTURBANCE (difficulty walking/limping), FATIGUE (fatigue/she felt tired), PAIN IN EXTREMITY (soreness of the arm) and CHILLS (chills). On 07-Oct-2023, GAIT DISTURBANCE (difficulty walking/limping), FATIGUE (fatigue/she felt tired), PAIN IN EXTREMITY (soreness of the arm) and CHILLS (chills) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.