chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Arexvy was administered when she was 36 weeks pregnant; Arexvy is not approved for patients under 60 years old; Patient was given Arexvy instead of Abrysvo; This non-serious retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-SEP-2023, the patient received Arexvy. On 19-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Arexvy is not approved for patients under 60 years old) and wrong vaccine administered (Verbatim: Patient was given Arexvy instead of Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy was administered when she was 36 weeks pregnant). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester  Pregnancy Details (Neonate 1):  Pregnancy Outcome: Live neonate with no apparent congenital anomaly Delivery Notes: patient gave birth at 39 weeks   Additional Information: GSK Receipt Date: 10-OCT-2023 The patient was self-reported this case. The patient was received Arexvy vaccine instead of Abrysvo when she was 36 weeks pregnant, which led to wrong vaccine administered and vaccine exposure during pregnancy. The patient gave birth a week ago at 39 weeks. The patient received Arexvy who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix reconstituted with 2 lyophilized vials and 1 adjuvant vial; patient received Shingrix reconstituted with 2 lyophilized vials and 1 adjuvant vial; 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 54-year-old female patient who received Herpes zoster (Shingrix) (batch number BT479, expiry date 15-SEP-2025) for prophylaxis.   On 25-SEP-2023, the patient received Shingrix. On 25-SEP-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix reconstituted with 2 lyophilized vials and 1 adjuvant vial) and inappropriate dose of vaccine administered (Verbatim: patient received Shingrix reconstituted with 2 lyophilized vials and 1 adjuvant vial).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter reported that patient received Shingrix reconstituted with 2 lyophilized vials and 1 adjuvant vial, which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: 4 year old female kid received Boostrix as a 5th dose of the Dtap series instead of a Dtap vaccine; 4 year old female kid received Boostrix as a 5th dose of the Dtap series instead of a Dtap vaccine; 4 year old female kid received 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 4-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DD7F7, expiry date 06-DEC-2025) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: 4 year old female kid received Boostrix as a 5th dose of the Dtap series instead of a Dtap vaccine), adult product administered to child (Verbatim: 4 year old female kid received Boostrix as a 5th dose of the Dtap series instead of a Dtap vaccine) and underdose (Verbatim: 4 year old female kid received Boostrix).  The outcome of the wrong vaccine administered, adult product administered to child and underdose were unknown.   Additional Information: GSK Receipt date: 10-OCT-2023 Office Manager reported that a 4 year old female kid received Boostrix as a 5th dose of the Dtap series instead of a Dtap vaccine which led to Wrong vaccine administered, adult product administered to child and underdose. The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient was administered Boostrix on 12Sep2023 and inadvertently again on 06Oct2023.; 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 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TB723, expiry date 17-OCT-2025) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 06-OCT-2023, the patient received the 2nd dose of Boostrix. On 06-OCT-2023, an unknown time after receiving Boostrix and an unknown time after receiving BOOSTRIX, the patient experienced drug dose administration interval too short (Verbatim: patient was administered Boostrix on 12Sep2023 and inadvertently again on 06Oct2023.).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter was a Medical Assistant. The reporter stated that on 12 September 2023 the patient administered Boostrix and inadvertently again administered on 06 October 2023, which led to shortening of vaccination schedule. The vaccine administration facility was the same as primary reporter. The reported consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administering Kinrix today instead of Pediarix to a 6 month old patient which would have been patients 3rd dose of Pediarix; 6 month old patient received kinrix; 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 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 25zh4, expiry date 27-OCT-2024) for prophylaxis.   On 10-OCT-2023, the patient received Kinrix. On 10-OCT-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: administering Kinrix today instead of Pediarix to a 6 month old patient which would have been patients 3rd dose of Pediarix) and inappropriate age at vaccine administration (Verbatim: 6 month old patient received kinrix).  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.   Additional Information: GSK Receipt date: 10-OCT-2023 A licensed practical nurse reported that administering Kinrix on the day of reporting instead of Pediarix which would had been patient's 3rd dose of Pediarix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect route of product administration
Clinical narrative: it is possible the dose was given subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 35AD3, expiry date 23-JAN-2025) for prophylaxis.   The patient's past medical history included shoulder operation.   On 10-OCT-2023, the patient received Arexvy (subcutaneous, right arm). On 10-OCT-2023, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: it is possible the dose was given subcutaneous).  The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter reported that the patient came in for Arexvy vaccine on reporting day. The reporter reported that intended to administer in the right deltoid muscle, but patient stated that it felt like the needle did not go in very far and she hit something. Afterward the patient told reporter that she had shoulder surgery on that side and had some metal there. The reporter stated that it was possible that the dose was given subcutaneous, which led to intramuscular formulation administered by other route. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: dose of Hiberix was reconstituted with sterile water from a Merck product instead of the accompanying diluent; Inappropriate dose of vaccine administered; 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 15-month-old female patient who received Hib (Hiberix) (batch number MP29Y, expiry date 13-JUN-2024) for prophylaxis.   On 10-OCT-2023, the patient received Hiberix. On 10-OCT-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: dose of Hiberix was reconstituted with sterile water from a Merck product instead of the accompanying diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 11-OCT-2023 The medical assistant reported a dose of Hiberix was reconstituted with sterile water from a Merck product instead of the accompanying diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered  The reporter consented to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Therapy non-responder
Clinical narrative: non immune to hepatitis A; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a male patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine.   On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced therapy non-responder (Verbatim: non immune to hepatitis A).  The outcome of the therapy non-responder was unknown.   Additional Information: GSK Receipt Date: 11-OCT-2023 The reporter stated that a patient received the individual Hepatitis A & Hepatitis B vaccines a few years ago. He had since become non immune to Hepatitis A but still was immune to Hepatitis B. The vaccine administration facility is the same as primary reporter.  The Healthcare professional did not know the brand Hepatitis A the patient received.
Sex: U
Vaccine: DTAP, DTAPIPV, HEP, HEPA, HIBV, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: product storage error/vaccines were administered to an unknown number of patients at unknown dates; 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 (Infanrix) (batch number 9R2D7) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) (batch number 7745R) for prophylaxis, HAV (Havrix 720) (batch number Y3ME2) for prophylaxis, HBV (Engerix B Junior) (batch number 99A45) for prophylaxis, Hib (Hiberix) (batch number 4R9T4) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number AMVA950A) for prophylaxis, Men B NVS (Bexsero) (batch number XX33P) for prophylaxis and DTPa (Reduced antigen) (Boostrix) (batch number 2B723) for prophylaxis.   On an unknown date, the patient received Infanrix, Kinrix, Havrix 720, Engerix B Junior, Hiberix, Menveo, Bexsero and Boostrix. On an unknown date, an unknown time after receiving Infanrix, Kinrix, Havrix 720, Engerix B Junior, Hiberix, Menveo, Bexsero and Boostrix, the patient experienced incorrect storage of drug (Verbatim: product storage error/vaccines were administered to an unknown number of patients at unknown dates). 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: 11-OCT-2023 The office manager states Infanrix, Havrix, Engerix-B, Kinrix, Hiberix, Menveo (2 vial), Bexsero, and Boostrix had excursions from 01-SEP-2023 to 22-SEP-2023 and were exposed to 33.76 F (Fahrenheit) and 51.35 F and 31.3 F and 41.0 F. The reporter did not know how long the vaccines were above the recommended range.  Prior 01-AUG-2023, 34.70 F and 51.35 F, from 04-AUG-2023 to 31-AUG-2023, 34.70 F and 51.35 F, from 25-JUL-2023 to 31-JUL-2023, 35.51 F and 41.93 F. Time above recommended range unknown. These vaccines were administered to an unknown number of patients at unknown dates. The vaccine administration facility was the same as primary reporter. The healthcare professional (HCP) did not had any patient identifiers or expiration dates for the vaccines at the time of the call. The reporter consented to follow up via postal.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: an expired Infanrix was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 11-OCT-2023, the patient received Infanrix. On 11-OCT-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: an expired Infanrix was administered to a patient).  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: 10-OCT-2023 It was reported that an expired Infanrix was administered to a patient which led to expired vaccine used. The reporter gives consent to follow up with Healthcare Professional
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Conjunctivitis, Fatigue, Headache, Malaise, Mobility decreased
Clinical narrative: a rash on her face/ rash under eyes; blotchy rash; red rash/ red blanching; red eyes/ eyes were beet red; Pinkeye; fatigue; stayed in bed; didn't feel well; started retching; vomiting; headache; fever of 100 Fahrenheit temperature; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-OCT-2023, the patient received Arexvy (right arm). On 10-OCT-2023, 1 days after receiving Arexvy, the patient experienced exanthema facial (Verbatim: a rash on her face/ rash under eyes), blotchy rash (Verbatim: blotchy rash), red rash (Verbatim: red rash/ red blanching), eye red (Verbatim: red eyes/ eyes were beet red), pinkeye (Verbatim: Pinkeye), fatigue (Verbatim: fatigue) and bedridden (Verbatim: stayed in bed). In OCT-2023, the patient experienced feeling unwell (Verbatim: didn't feel well), retching (Verbatim: started retching), vomiting (Verbatim: vomiting), headache (Verbatim: headache) and fever (Verbatim: fever of 100 Fahrenheit temperature).  The outcome of the feeling unwell, retching, blotchy rash and bedridden were not reported and the outcome of the vomiting, headache, fever, red rash, eye red, pinkeye and fatigue were unknown and the outcome of the exanthema facial was not resolved.   It was unknown if the reporter considered the feeling unwell, retching, vomiting, headache, fever, exanthema facial, blotchy rash, red rash, eye red, pinkeye, fatigue and bedridden to be related to Arexvy.     It was unknown if the company considered the feeling unwell, retching, vomiting, headache, fever, exanthema facial, blotchy rash, red rash, eye red, pinkeye, fatigue and bedridden to be related to Arexvy.   Additional Information: GSK receipt date: 11-OCT-2023 Reporter was the patient, who received a dose of Arexvy on Monday. She stated that during that night did not felt well. The patient started retching and started to vomit, then experienced a severe headache in bed that night with fever of 100 degree Fahrenheit temperature.  The next morning, a rash was all over face that was blotchy and red with red blanching , eyes were beet red like pink eye.  Then on Tuesday, had fatigue the entire day and stayed in bed.  Out of everything no pain in the arm that was injected. The patient mentioned still have leftover rash on right side of face under eyes.  The reporter consented to follow up from safety
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Ocular hyperaemia, Pallor, Rash, Rash erythematous, Rash macular
Clinical narrative: a rash on her face/ rash under eyes; blotchy rash; red rash/ red blanching; red eyes/ eyes were beet red; Pinkeye; fatigue; stayed in bed; didn't feel well; started retching; vomiting; headache; fever of 100 Fahrenheit temperature; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-OCT-2023, the patient received Arexvy (right arm). On 10-OCT-2023, 1 days after receiving Arexvy, the patient experienced exanthema facial (Verbatim: a rash on her face/ rash under eyes), blotchy rash (Verbatim: blotchy rash), red rash (Verbatim: red rash/ red blanching), eye red (Verbatim: red eyes/ eyes were beet red), pinkeye (Verbatim: Pinkeye), fatigue (Verbatim: fatigue) and bedridden (Verbatim: stayed in bed). In OCT-2023, the patient experienced feeling unwell (Verbatim: didn't feel well), retching (Verbatim: started retching), vomiting (Verbatim: vomiting), headache (Verbatim: headache) and fever (Verbatim: fever of 100 Fahrenheit temperature).  The outcome of the feeling unwell, retching, blotchy rash and bedridden were not reported and the outcome of the vomiting, headache, fever, red rash, eye red, pinkeye and fatigue were unknown and the outcome of the exanthema facial was not resolved.   It was unknown if the reporter considered the feeling unwell, retching, vomiting, headache, fever, exanthema facial, blotchy rash, red rash, eye red, pinkeye, fatigue and bedridden to be related to Arexvy.     It was unknown if the company considered the feeling unwell, retching, vomiting, headache, fever, exanthema facial, blotchy rash, red rash, eye red, pinkeye, fatigue and bedridden to be related to Arexvy.   Additional Information: GSK receipt date: 11-OCT-2023 Reporter was the patient, who received a dose of Arexvy on Monday. She stated that during that night did not felt well. The patient started retching and started to vomit, then experienced a severe headache in bed that night with fever of 100 degree Fahrenheit temperature.  The next morning, a rash was all over face that was blotchy and red with red blanching , eyes were beet red like pink eye.  Then on Tuesday, had fatigue the entire day and stayed in bed.  Out of everything no pain in the arm that was injected. The patient mentioned still have leftover rash on right side of face under eyes.  The reporter consented to follow up from safety
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Retching, Vomiting
Clinical narrative: a rash on her face/ rash under eyes; blotchy rash; red rash/ red blanching; red eyes/ eyes were beet red; Pinkeye; fatigue; stayed in bed; didn't feel well; started retching; vomiting; headache; fever of 100 Fahrenheit temperature; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-OCT-2023, the patient received Arexvy (right arm). On 10-OCT-2023, 1 days after receiving Arexvy, the patient experienced exanthema facial (Verbatim: a rash on her face/ rash under eyes), blotchy rash (Verbatim: blotchy rash), red rash (Verbatim: red rash/ red blanching), eye red (Verbatim: red eyes/ eyes were beet red), pinkeye (Verbatim: Pinkeye), fatigue (Verbatim: fatigue) and bedridden (Verbatim: stayed in bed). In OCT-2023, the patient experienced feeling unwell (Verbatim: didn't feel well), retching (Verbatim: started retching), vomiting (Verbatim: vomiting), headache (Verbatim: headache) and fever (Verbatim: fever of 100 Fahrenheit temperature).  The outcome of the feeling unwell, retching, blotchy rash and bedridden were not reported and the outcome of the vomiting, headache, fever, red rash, eye red, pinkeye and fatigue were unknown and the outcome of the exanthema facial was not resolved.   It was unknown if the reporter considered the feeling unwell, retching, vomiting, headache, fever, exanthema facial, blotchy rash, red rash, eye red, pinkeye, fatigue and bedridden to be related to Arexvy.     It was unknown if the company considered the feeling unwell, retching, vomiting, headache, fever, exanthema facial, blotchy rash, red rash, eye red, pinkeye, fatigue and bedridden to be related to Arexvy.   Additional Information: GSK receipt date: 11-OCT-2023 Reporter was the patient, who received a dose of Arexvy on Monday. She stated that during that night did not felt well. The patient started retching and started to vomit, then experienced a severe headache in bed that night with fever of 100 degree Fahrenheit temperature.  The next morning, a rash was all over face that was blotchy and red with red blanching , eyes were beet red like pink eye.  Then on Tuesday, had fatigue the entire day and stayed in bed.  Out of everything no pain in the arm that was injected. The patient mentioned still have leftover rash on right side of face under eyes.  The reporter consented to follow up from safety
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Engerix-B was administered to a patient.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received HBV (Engerix B) (batch number 39T22, expiry date 07-SEP-2023) for prophylaxis.   On 11-OCT-2023, the patient received Engerix B. On 11-OCT-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired dose of Engerix-B was administered to a patient.).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 11-OCT-2023 Pharmacist called to report an expired dose of Engerix-B was administered to a patient inadvertently, which led to expired vaccine used. No side effects reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. No additional information provided.
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: tingling; This non-serious case was reported by a nurse via call center representative and described the occurrence of tingling in a 74-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced tingling (Verbatim: tingling). The outcome of the tingling was unknown.   It was unknown if the reporter considered the tingling to be related to Flu vaccine.     It was unknown if the company considered the tingling to be related to Flu vaccine.  Additional Information: GSK Receipt Date: 11-OCT-2023 The nurse reported tingling following a flu vaccine 10 years ago (from the reporting date), thought it was the start of Guillain-Barre but did not develop into Guillain-Barre. The reporter was unsure of which flu vaccine was administered. The reporter consented to follow up.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle disorder, Pain in extremity, Paraesthesia
Clinical narrative: feel a sharp tingling (tangy) pain for a moment; muscle of her injected arm "is still giving me trouble; pain of the injected arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax and flu vaccine with an associated reaction of no adverse event.   On 11-FEB-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced tingling sensation (Verbatim: feel a sharp tingling (tangy) pain for a moment), muscle disorder (Verbatim: muscle of her injected arm "is still giving me trouble) and pain in arm (Verbatim: pain of the injected arm).  The outcome of the tingling sensation, muscle disorder and pain in arm were not resolved.   It was unknown if the reporter considered the tingling sensation and muscle disorder to be related to Shingrix. The reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the tingling sensation and muscle disorder to be related to Shingrix. The company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date: 12-OCT-2023 The patient self-reported.  She got her first shot of Shingrix on February 11, 2023 in the left arm.  She was unable to find the lot number of the vaccine given but did provide the contact information for the pharmacy where the shot was administered.  She reports that even though she got the Shingrix shot 8 months ago the muscle of her injected arm was still giving me trouble.  She said that there was no pain during the injection but about 2-3 days later she felt that something went awry and she indicated that she had no problem moving the injected arm but sometimes when she had her arm in certain positions, for example, if she lifts her arm or turns it she will feel a sharp tingling (tangy) pain for a moment. Due to this she had not taken Shingrix shot 2.  The patient did not consent to follow-up.
Sex: F
Vaccine: FLU4
Symptoms: Injury associated with device
Clinical narrative: needle stick; This non-serious case was reported by a other health professional via call center representative and described the occurrence of needle stick/puncture in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number MC355), (batch number A75G3) and (batch number 9E5KE) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, an unknown time after receiving FluLaval Quadrivalent, the patient experienced needle stick/puncture (Verbatim: needle stick).  The outcome of the needle stick/puncture was not resolved.   It was unknown if the reporter considered the needle stick/puncture to be related to FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the needle stick/puncture to be related to FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device.   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: 12-OCT-2023 The reporter is the nurse manager who stated one medical assistant received a needle stick after administering the Flulaval vaccine to a patient. No harm was done to the patient. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: inquires if they need to give them the third dose or start over; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (patient received the second dose on 15-NOV-2022).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: inquires if they need to give them the third dose or start over).  The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-OCT-2023 The pharmacist reported that a patient received the 2nd dose of the Twinrix vaccine and inquired if they need to give them the 3rd dose or start over. The reporter consented to follow up. Till the time of reporting, the patient did not receive 3rd dose of Twinrix vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administration of an expired Twinrix dose to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 11-OCT-2023, the patient received Twinrix. On 11-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Twinrix dose to patient).  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: 12-OCT-2023 A pharmacist called to report the administration of an expired Twinrix dose to patient, which led to expired vaccine used.  The healthcare professional asked how to proceed with this patient. The reporter consented to follow up.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix was administered to a 7-year-old patient.; Infanrix was administered but planned vaccine was Tdap; 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 7-year-old male patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On 06-OCT-2023, the patient received Infanrix. On 06-OCT-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix was administered to a 7-year-old patient.) and wrong vaccine administered (Verbatim: Infanrix was administered but planned vaccine was Tdap).  The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 12-OCT-2023 A nurse reported that Infanrix was administered to a 7-year-old patient but nurse states planned vaccine to be given was Tdap which led to Wrong vaccine administered and Inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix was administered to an 8-year-old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5A160084252) for prophylaxis.   On 27-SEP-2023, the patient received Boostrix. On 27-SEP-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix was administered to an 8-year-old patient).  The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2023 The reporter called to report Boostrix was administered to 8 year old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up via email.
Age: 38.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Arexvy was administered to a pregnant patient instead of the Pfizer brand RSV vaccine that is indicated for pregnant patients; Inappropriate Age at Vaccine Administration; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 38-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-OCT-2023, the patient received Arexvy. On 07-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Age at Vaccine Administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy was administered to a pregnant patient instead of the Pfizer brand RSV vaccine that is indicated for pregnant patients).  The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 12-OCT-2023 The vaccine administration facility was the same as primary reporter The pharmacist stated Arexvy was administered to a pregnant patient instead of the Pfizer brand RSV vaccine that is indicated for pregnant patients, which led to inappropriate age at vaccine administration. HCP gave permission for follow up but stated that she would not had any additional information as she did not see the patient
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Chest pain, Headache, Injection site pain, Mobility decreased, Pain
Clinical narrative: had a fever of 101 F; having chest pain that got worst on Monday; patient had a little bit of pain at the injection site; mild headache; body ache; patient took a Covid-19 test resulting negative; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-OCT-2023, the patient received Arexvy (left arm). On 07-OCT-2023, 1 days after receiving Arexvy, the patient experienced injection site pain (Verbatim: patient had a little bit of pain at the injection site). On 08-OCT-2023, the patient experienced chest pain (Verbatim: having chest pain that got worst on Monday). On 09-OCT-2023, the patient experienced fever (Verbatim: had a fever of 101 F). In OCT-2023, the patient experienced headache (Verbatim: mild headache), general body pain (Verbatim: body ache) and covid-19 virus test negative (Verbatim: patient took a Covid-19 test resulting negative). The outcome of the injection site pain, chest pain, fever, headache and general body pain were resolving and the outcome of the covid-19 virus test negative was unknown.   It was unknown if the reporter considered the injection site pain, chest pain, fever, headache, general body pain and covid-19 virus test negative to be related to Arexvy.     It was unknown if the company considered the injection site pain, chest pain, fever, headache, general body pain and covid-19 virus test negative to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-OCT-2023 The patient received Arexvy on Friday and on Saturday, she had little bit of pain at the injection site. 2 days after vaccination, on Sunday, she had chest pain which got worst on Monday. 3 days after vaccination, on Monday, she also had a fever of 101 Fahrenheit. In October 2023, the patient took a Covid-19 test resulting and it was result was negative. The patient also had body ache, describing that even sitting on her recliner she felt ache crossing and uncrossing her legs. During these days she also had mild headache. On 10th October 2023 (Tuesday), she was feeling a little bit better and then on 11th October 2023 (Wednesday) and on the day of reporting, the patient was better.  The reporter did not consent to followup.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: had a fever of 101 F; having chest pain that got worst on Monday; patient had a little bit of pain at the injection site; mild headache; body ache; patient took a Covid-19 test resulting negative; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-OCT-2023, the patient received Arexvy (left arm). On 07-OCT-2023, 1 days after receiving Arexvy, the patient experienced injection site pain (Verbatim: patient had a little bit of pain at the injection site). On 08-OCT-2023, the patient experienced chest pain (Verbatim: having chest pain that got worst on Monday). On 09-OCT-2023, the patient experienced fever (Verbatim: had a fever of 101 F). In OCT-2023, the patient experienced headache (Verbatim: mild headache), general body pain (Verbatim: body ache) and covid-19 virus test negative (Verbatim: patient took a Covid-19 test resulting negative). The outcome of the injection site pain, chest pain, fever, headache and general body pain were resolving and the outcome of the covid-19 virus test negative was unknown.   It was unknown if the reporter considered the injection site pain, chest pain, fever, headache, general body pain and covid-19 virus test negative to be related to Arexvy.     It was unknown if the company considered the injection site pain, chest pain, fever, headache, general body pain and covid-19 virus test negative to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-OCT-2023 The patient received Arexvy on Friday and on Saturday, she had little bit of pain at the injection site. 2 days after vaccination, on Sunday, she had chest pain which got worst on Monday. 3 days after vaccination, on Monday, she also had a fever of 101 Fahrenheit. In October 2023, the patient took a Covid-19 test resulting and it was result was negative. The patient also had body ache, describing that even sitting on her recliner she felt ache crossing and uncrossing her legs. During these days she also had mild headache. On 10th October 2023 (Tuesday), she was feeling a little bit better and then on 11th October 2023 (Wednesday) and on the day of reporting, the patient was better.  The reporter did not consent to followup.
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: patient received Infanrix instead of Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis.   On 12-OCT-2023, the patient received Infanrix. On 12-OCT-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: patient received Infanrix instead of Boostrix). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-OCT-2023 A nurse reported that a patient received Infanrix instead of Boostrix, which led to wrong vaccine administered. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who received 1st dose in 2021 and returned today (12-OCT-2023) for 2nd 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 25-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (1st dose received in 2021).   On an unknown date, the patient did not receive the 2nd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced incomplete course of vaccination (Verbatim: patient who received 1st dose in 2021 and returned today (12-OCT-2023) for 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2023 The pharmacist requested data on administration of Engerix-B dose to a patient who received 1st dose in 2021 and returned today (on the day of reporting) for 2nd dose.  The reporter wanted to know did the patient need to restart the series. The pharmacist indicated that patient did not receive 1st Engerix-B dose at their pharmacy, exact date of administration unknown. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Engerix B adult, which led to incomplete course of vaccination.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Incorrect dose administered
Clinical narrative: the administration of an extra dose of Pediarix to a 2 month old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 25L32, expiry date 28-MAR-2025) for prophylaxis.   Concomitant products included PEDIARIX.   On 12-OCT-2023, the patient received the 2nd dose of Pediarix. On 12-OCT-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: the administration of an extra dose of Pediarix to a 2 month old patient).  The outcome of the overdose 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: 09-MAR-2023 An health care professional (HCP) called to report the administration of an extra dose of Pediarix to a 2 month old patient.  The HCP asked for guidance on this situation. Both doses were administered same date at the same time, which led to overdose. The reporter permission to follow up was not requested.
Sex: M
Vaccine: RSV
Symptoms: Death
Clinical narrative: Death; This serious case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 14-OCT-2023, the patient received Arexvy. On 16-OCT-2023, 2 days after receiving Arexvy, the patient experienced unknown cause of death (Verbatim: Death) (serious criteria death, GSK medically significant and life threatening).  The patient died on 16-OCT-2023. The reported cause of death was unknown.   The reporter considered the unknown cause of death to be related to Arexvy.     The company considered the unknown cause of death to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-OCT-2023 Sales Representative called after leaving doctor's office and reported that 67 year old healthy patient received Arexvy and died. The reporter believed that death happened on Monday but provider's office was very busy and she was really rushed but MD (doctor of medicine) was agreeable to follow up by GSK. The reporter believed Arexvy was administered 48 hours prior to death on Saturday at a pharmacy. The reporter consented to follow up. No further information was available regarding patient, product or event.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Novavax) concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 1) (form of admin, route of administration, batch number was not reported, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient had allergic reaction after first dose of pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported 1 total administered for covid-19 prophylaxis which was off label dosing frequency and revaccination with different covid-19 vaccine (dose number in series 3). The product was associated with Off label use. The batch number was not reported and has been requested. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label dosing frequency and revaccination with different covid-19 vaccine was not reported. This report was non-serious.