chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, shoulder to elbow; Redness, shoulder to elbow; Pain, shoulder to elbow; This non-serious case was reported by a nurse via sales rep and described the occurrence of swelling arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to animal (Hamster).   In APR-2023, the patient received the 2nd dose of Shingrix. In APR-2023, an unknown time after receiving Shingrix, the patient experienced swelling arm (Verbatim: Swelling, shoulder to elbow), erythema of extremities (Verbatim: Redness, shoulder to elbow) and pain in arm (Verbatim: Pain, shoulder to elbow). In APR-2023, the outcome of the swelling arm, erythema of extremities and pain in arm were resolved (duration 6 days).   It was unknown if the reporter considered the swelling arm, erythema of extremities and pain in arm to be related to Shingrix.     It was unknown if the company considered the swelling arm, erythema of extremities and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2023 Registered nurse reported this case for herself.  The patient received her second dose of Shingrix about 2 weeks from reporting and experienced pain, redness, and swelling from her shoulder to her elbow for about 5 to 6 days. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix given instead of Infanrix; Patient under the age of 2 years old received a dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 34FR4, expiry date 23-SEP-2024) for prophylaxis.   On 05-JAN-2023, the patient received Boostrix. On 05-JAN-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix given instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: Patient under the age of 2 years old received a dose of Boostrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023056836   Additional Information: GSK Receipt Date: 18-APR-2023 The reporter stated that they gave the incorrect vaccine to the patient. The patient was given Boostrix instead of Infanrix. The medical assistant reported that a patient under the age of 2 years old, received a dose of Boostrix.  No symptoms were reported. The vaccine administration facility is the same as primary reporter. The reporter consented to follow-up via email. The patient received a dose of Boostrix at an inappropriate age instead of Infanrix, which led to inappropriate age at vaccine administration and wrong vaccine used. This case was found as duplicate of case US2023056836. All the information from the case US2023056836 was merged into this case. The case US2023056836 was deleted and this case stand as case of record for this patient.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not get yet; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   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: 2nd dose not get yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-APR-2023 The physician stated that his/her patient forgot to get the second and enquired about what was the recommendation regarding them getting the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Adjuvant only administered; Adjuvant only administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old patient who received Herpes zoster (Shingrix) (batch number MY2Y2, expiry date 08-JUL-2024) for prophylaxis.   On 18-APR-2023, the patient received the 1st dose of Shingrix. On 18-APR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant only administered) and inappropriate dose of vaccine administered (Verbatim: Adjuvant only administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-APR-2023 The certified medical assistant informed that earlier on the day of reporting the patient received 1st dose of Shingrix. Only the adjuvant part of the Shingrix was administer to the patient. The reporter did not consent to follow up. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The second was administered on 2/23/2023; 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 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 5592T, expiry date 12-OCT-2023) for prophylaxis.   Previously administered products included Shingrix (first dose received on October 2021).   On 23-FEB-2023, the patient received the 2nd dose of Shingrix. On 23-FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: The second was administered on 2/23/2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 18-April-2023 The pharmacist reported that the patient received Shingrix first dose on October 2021 but the second dose was administered on 23 February 2023. 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: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not follow up for the second dose on time; 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 (first dose received in November 2022).   On 18-APR-2023, the patient received the 2nd dose of Twinrix. On 18-APR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Did not follow up for the second dose on time). 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: 19-Apr-2023 The pharmacist stated that the patient was calling from home and did not have access to patient information at this time. The pharmacist did not have initials, date of birth, or any additional information available at the time of call.  The pharmacist consents to follow up but stated might not have any further information she could provide to safety. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Sterile water used as diluent; Sterile water used as diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA794A, 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: Sterile water used as diluent) and inappropriate dose of vaccine administered (Verbatim: Sterile water used as diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 19-Apr-2023 The medical assistant called to inform that on an unknown date, a patient was administered a dose of Menveo, which was mixed using sterile water instead of the Menveo provided diluent.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The healthcare professional did not have information of the patient or the date of administration, but agreed for the follow up by GSK safety team. The patient received the Menveo which was mixed with sterile water instead of provided diluent, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Chemotherapy, Incomplete course of vaccination, Lymphoma
Clinical narrative: Did not receive dose 2 as of yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received in November 2019). Concurrent medical conditions included lymphoma.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Did not receive dose 2 as of yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Apr-2023 This case was self reported by the patient.        The patient received first dose of Shingrix in November 2019.  The patient started chemo shortly thereafter for history of lymphoma.  The patient did not receive dose 2 as of yet.  The education provided, referred to healthcare professional. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 4th dose received at 14 months; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 14-month-old male patient who received DTPa (Infanrix) (batch number 7C9NJ) for prophylaxis.   Previously administered products included Infanrix (patient was 6 months old when they started vaccine).   On 19-APR-2023, the patient received the 4th dose of Infanrix. On 19-APR-2023, an unknown time after receiving Infanrix, the patient experienced drug dose administration interval too short (Verbatim: 4th dose received at 14 months). 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: 19-Apr-2023 The medical assistant called on behalf of the patient.  The reporter reported that the patient received Infanrix dose early.  The reporter reported that the patient received 4th dose Infanrix.  The reporter reported that the patient was 6 months old when they started vaccine, so 4th dose was supposed to be administered at 16 to 18 months, but patient received at 14 months (current age).  The reporter consented to follow up. The patient received 4th dose of Infanrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Diluent given without powder; Diluent given without powder; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in 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 inappropriate preparation of medication (Verbatim: Diluent given without powder) and inappropriate dose of vaccine administered (Verbatim: Diluent given without powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 19-Apr-2023 No additional adverse event details available as per health care professional. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received possible Menveo diluent without powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Head cracked open. ER visit required; Collapsed; This non-serious case was reported by a consumer via call center representative and described the occurrence of head injury in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced head injury (Verbatim: Head cracked open. ER visit required) and fall (Verbatim: Collapsed). The outcome of the head injury and fall were unknown.   It was unknown if the reporter considered the head injury and fall to be related to Shingrix.     It was unknown if the company considered the head injury and fall to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-APR-2023 The friend of patient reported the case. Few weeks after receiving the Shingrix the patient collapsed and cracked his head opened. The patient went to the emergency room for stitches. The reporter had limited information, nothing else was reported. The reporter did not consented to follow-up. This case is linked with US2023057552, for the same reporter.; Sender's Comments:  US-GSK-US2023057552:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Got 1st dose, more than 6 months 2nd not yet.; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   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: Got 1st dose, more than 6 months 2nd not yet.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Apr 2023 The physician  reported that if a patient took one (first) dose of Shingrix and did not get the second dose within 6 months. The reporter asked that they need to start over with first dose again. The medical informer did not speak with the health care provider. For more information please follow-up with sales representative. The reporter consented to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 05Aug2021, 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 5th August 2021).   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: 1st dose 05Aug2021, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Apr-2023 A pharmacist called in to ask for information about a patient who did not receive the second dose. The reporter asked if the patient had to restart the vaccine series. The reporter did not provided information about first Shingrix dose (lot number, expiration date). The reporter consented to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose was given by accident; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 29-year-old male patient who received HBV (Engerix B) (batch number N4GA4, expiry date 02-JAN-2023) for prophylaxis.   On 19-APR-2023, the patient received the 1st dose of Engerix B. On 19-APR-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose was given by accident). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 19-APR-2023 A physician wanted to know how to proceed further. Information about the patient and vaccine were given. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient accidently expired dose of Engerix B, which led to expired vaccine used.
Age: 35.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose was 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 35-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 19-APR-2023, the patient received Havrix. On 19-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose was administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 19-APR-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up and requested to send an email. The patient received expired Havrix vaccine, which led to expired vaccine used.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only diluent administered; Only diluent administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-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, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-Apr-2023 The reporter consented to follow-up. The patient received only the diluent of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Temperature excursion 5.76 degree fahrenheit for 20 sec, Vaccine given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: Temperature excursion 5.76 degree fahrenheit for 20 sec, Vaccine given). 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: 20-APR-2023 The healthcare professional stated that according with original thermometer inside refrigerator, the lowest temperature was 5.76 degree Fahrenheit for 20 seconds on 27-MAR-2023. No alarm. However, on the same day, the backup thermometer showed a lowest temperature of 36.21 degree Fahrenheit. The healthcare professional stated that they had been using these vaccines. No Kinrix lot numbers available at the time of reporting. The reporter consented to follow up.  Kinrix was stored below recommended storage temperature which led to incorrect storage of vaccine.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vaccine mixed with a non-GSK diluent; Patient received vaccine mixed with a non-GSK diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA859A, expiry date 31-JAN-2024) for prophylaxis.   On 21-MAR-2023, the patient received Menveo. On 21-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Vaccine mixed with a non-GSK diluent) and inappropriate dose of vaccine administered (Verbatim: Patient received vaccine mixed with a non-GSK diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The reporter reported that the patient was received Menveo vaccine that was mixed with non GSK diluent. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The reporter gave by error Menveo  vaccine mixed with non GSK diluent portion,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Age: 29.0
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Adult patient received Hiberix; Patient completed series when younger; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 29-year-old male patient who received Hib (Hiberix) (batch number 97AP3, expiry date 09-NOV-2023) for prophylaxis.   On 06-APR-2023, the patient received Hiberix. On 06-APR-2023, an unknown time after receiving Hiberix, the patient experienced adult use of a child product (Verbatim: Adult patient received Hiberix) and extra dose administered (Verbatim: Patient completed series when younger). The outcome of the adult use of a child product and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The occupational medicine clinician called to inquire that how to proceed to make sure patient was protected?  The reporter reported they inadvertently administered Hiberix to an adult patient.  The vaccine was administered in their facility.  The reporter confirmed that the patient completed series when younger.  The reporter did not consent to follow-up. The adult patient received Hiberix, which led to adult use of a child product and extra dose administered.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Vaccine reconstituted with sterile water; Received vaccine reconstituted with sterile water; 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 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 29EY3, expiry date 28-JUN-2024) for prophylaxis.   On 15-MAR-2023, the patient received the 2nd dose of Shingrix. On 15-MAR-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Vaccine reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Received vaccine reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The reporter reported that the patient received Shingrix vaccine which was reconstituted with sterile water. The reporter did consent to follow up via email. Shingrix vaccine reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pediatric patient received an adult dose; 20 month old patient received an adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 20-month-old male patient who received HAV (Havrix adult) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   Previously administered products included Havrix (1st dose received on 17th October 2022).   On 21-APR-2023, the patient received Havrix adult (left thigh). On 21-APR-2023, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: Pediatric patient received an adult dose) and adult product administered to child (Verbatim: 20 month old patient received an adult dose). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2023 The reporter consented to follow up. A pediatric patient received an adult dose of Havrix which led to overdose and adult product administered.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Pain in extremity, Pruritus
Clinical narrative: Sore arm; Little bit of itching; Received a third dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in early 2022) and shingrix (2nd dose received in early 2022).   In APR-2023, the patient received the 3rd dose of Shingrix (intramuscular). In APR-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm), pruritus (Verbatim: Little bit of itching) and extra dose administered (Verbatim: Received a third dose). The outcome of the pain in arm, pruritus and extra dose administered were unknown.   It was unknown if the reporter considered the pain in arm and pruritus to be related to Shingrix.     It was unknown if the company considered the pain in arm and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-APR-2023 Reporter stated that he received a third dose of Shingrix approximately two weeks ago. His first two doses were done in early 2022, February or March, he was not sure.  He has had a sore arm and a "little bit of itching."  The reporter consented to follow up. At the time of reporting, the patient had received the 3th dose of Shingrix , which had led to extra dose administered.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 year old was given Boostrix; 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-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number H242K, expiry date 09-JUN-2025) for prophylaxis.   On 21-APR-2023, the patient received Boostrix. On 21-APR-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 6 year old was given Boostrix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 Clinical supervisor reported that a 6 year old was given a Boostrix.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. via phone.  No address was provided. The six year old patient was given Boostrix which led to Inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Neurological symptom, Tremor
Clinical narrative: neurological effects, like a muted GBS without paralysis; Body Tremors, both legs and upper torso; This non-serious case was reported by a other health professional via call center representative and described the occurrence of neurological symptom in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced neurological symptom (Verbatim: neurological effects, like a muted GBS without paralysis) and tremor (Verbatim: Body Tremors, both legs and upper torso). The outcome of the neurological symptom was not reported and the outcome of the tremor was unknown.   It was unknown if the reporter considered the neurological symptom and tremor to be related to Shingrix.     It was unknown if the company considered the neurological symptom and tremor to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-APR-2023 The healthcare professional inquired if there was any post marketing reported reactions to the Shingrix vaccine where the patient experienced body tremors.  The tremors would include both legs and upper torso almost like a muted Guillain-Barre syndrome which was without paralysis but similar evolution with neurological effects.
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: HOSPITALIZATION; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, after taking the vaccine, patient was hospitalized. It was reported that, the patient spent 98 days in the hospital after taking the shot and had to learn to walk again. The date of hospitalization and discharge information were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalization was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20230452533-hospitalization. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Herpes zoster, Muscular weakness, Ophthalmic herpes zoster
Clinical narrative: LEGS FEEL WEAK; FEELING WEAK; FELT SO EXHAUSTED; SHINGLES IN THE RIGHT EYE HAS GOTTEN WORSE; SHINGLES HAS PROGRESSED DOWN TO HER CHIN; This spontaneous report received from a patient concerned an (8 decade) elderly female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: shingles on the right side of face (in the top part of the cheek), and shingles in right eye since 2015.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 for covid-19 prophylaxis. Age at the time of vaccination 8 decade old. No concomitant medications were reported.  On an unspecified date in APR-2021, since the vaccine, patient experienced shingles in the right eye has gotten worse and the shingles has progressed down to her chin. Patient tried to mow yard in MAY-2021 and felt so exhausted that patient had to sit down several times during the process. After this incident patient visited her doctor because patient did not want to mow her yard and doctor advised that it was okay for patient to continue doing so. Patient mentions that she had not heard back from doctor since then, there have been no follow up appointments. On an unspecified date, patient's legs feel weak, patient did not feel good. Patient visited clinic a couple of months before date of reporting because patient was feeling weak. Patient explained concerns regarding the vaccine to the doctor, but states that the doctor did not address her concerns and did not question patient about her symptoms at all. Patient was 79 years old (at the time of report) and no one took patient seriously. Patient stated that she could not get anyone to listen to how terrible she feel. Patient hates vaccinations and patient only got this vaccine because of patient's husband and regrets getting it. Patient states that patient's conditions were not bad at first, but the last 2 years had been really bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt so exhausted, shingles in the right eye has gotten worse, shingles has progressed down to her chin, legs feel weak, and feeling weak was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230453913-shingles in the right eye has gotten worse. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 06-Jul-2022 with BUD as 05-Aug-2022 was administered to patient post use by date; No adverse event; Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Jul-2022 with BUD as 05-Aug-2022 was administered to patient post use by date) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Jul-2022 with BUD as 05-Aug-2022 was administered to patient post use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Jul-2022 with BUD as 05-Aug-2022 was administered to patient post use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Jul-2022 with BUD as 05-Aug-2022 was administered to patient post use by date).    Concomitant drugs were not reported.  It was reported that the monovalent individual vial of unknown size was administered to patients from 19-Sep-2022 until 09-Nov-2022. The vial was not exposed to temperature excursion. The vial was in the freezer and was moved to the refrigerator on 06-Jul-2022.  It was also reported that 6 patients received vaccine on 19-Sep-2022, 2 patients on 04-Oct-2022, 1 patient on 06-Oct-2022 and 1 patient on 09-Nov-2022. It was unknown if patients received full protection against COVID-19 virus.  Treatment medications were not provided.  This case contains information for the 2nd dose of 11th adult patient out of 12 as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-720531 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2023: Live Followup received, updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720531:
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain, Atrial fibrillation, Brain fog, Lacrimation increased, Postural orthostatic tachycardia syndrome
Clinical narrative: AFIB; fainting; POTS; constantly tearing eyes; abdominal pain; brain fog; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (AFIB) and SYNCOPE (fainting) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received 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 ATRIAL FIBRILLATION (AFIB) (seriousness criterion medically significant), SYNCOPE (fainting) (seriousness criterion medically significant), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS), LACRIMATION INCREASED (constantly tearing eyes), ABDOMINAL PAIN (abdominal pain) and FEELING ABNORMAL (brain fog). At the time of the report, ATRIAL FIBRILLATION (AFIB), SYNCOPE (fainting), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS), LACRIMATION INCREASED (constantly tearing eyes), ABDOMINAL PAIN (abdominal pain) and FEELING ABNORMAL (brain fog) had not resolved.            No concomitant medications were reported. The patient experienced unspecified more events and whatever the issues he was facing after the vaccine were not going away. Patient reported that he would never take a vaccine again. No treatment medications were reported.  Company comment: This spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) events of Atrial fibrillation (also AESI), Syncope; unexpected non serious AESI of Postural orthostatic tachycardia syndrome, unknown time after receiving a dose of mRNA-1273.222 bivalent vaccine. The patient also experienced constant tearing, abdominal pain and brain fog along with the events. No information on risk factors, detailed clinical course, relevant investigations, treatment of the events was available in the report. The events had not resolved. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-720715, US-MODERNATX, INC.-MOD-2023-720716 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live Non significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720715:14 year old US-MODERNATX, INC.-MOD-2023-720716:15 year old
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope
Clinical narrative: AFIB; fainting; POTS; constantly tearing eyes; abdominal pain; brain fog; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (AFIB) and SYNCOPE (fainting) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received 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 ATRIAL FIBRILLATION (AFIB) (seriousness criterion medically significant), SYNCOPE (fainting) (seriousness criterion medically significant), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS), LACRIMATION INCREASED (constantly tearing eyes), ABDOMINAL PAIN (abdominal pain) and FEELING ABNORMAL (brain fog). At the time of the report, ATRIAL FIBRILLATION (AFIB), SYNCOPE (fainting), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS), LACRIMATION INCREASED (constantly tearing eyes), ABDOMINAL PAIN (abdominal pain) and FEELING ABNORMAL (brain fog) had not resolved.            No concomitant medications were reported. The patient experienced unspecified more events and whatever the issues he was facing after the vaccine were not going away. Patient reported that he would never take a vaccine again. No treatment medications were reported.  Company comment: This spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) events of Atrial fibrillation (also AESI), Syncope; unexpected non serious AESI of Postural orthostatic tachycardia syndrome, unknown time after receiving a dose of mRNA-1273.222 bivalent vaccine. The patient also experienced constant tearing, abdominal pain and brain fog along with the events. No information on risk factors, detailed clinical course, relevant investigations, treatment of the events was available in the report. The events had not resolved. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-720715, US-MODERNATX, INC.-MOD-2023-720716 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live Non significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720715:14 year old US-MODERNATX, INC.-MOD-2023-720716:15 year old
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Menstrual disorder
Clinical narrative: Mistrual isses; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MENSTRUAL DISORDER (Mistrual isses) in a 14-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 MENSTRUAL DISORDER (Mistrual isses). At the time of the report, MENSTRUAL DISORDER (Mistrual isses) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720710 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live Non significant follow up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720710:Reporter case
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Menstrual disorder
Clinical narrative: Mistrual isses; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MENSTRUAL DISORDER (Mistrual isses) in a 15-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 MENSTRUAL DISORDER (Mistrual isses). At the time of the report, MENSTRUAL DISORDER (Mistrual isses) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720710 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live Non significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720710:Reporter case