chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; called to report that a dose of VARIVAX was inadvertently administered after suffering a TE. The supported TE case number is 02474995. No additional AE/PQC.  ?    Names of vaccines involved (including lot/exp) VARIVAX  X001000  1/9/2025; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.       On 19-SEP-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X001000 and expiration date 09-JAN-2025, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (product storage error and no adverse event). The time excursion lasted 19 minutes in temperature of -12.1 Celsius degree.
Sex: U
Vaccine: SMALLMNK
Symptoms: Product storage error
Clinical narrative: 0.1 mL intradermally for two Jynneos doses six doses administered to three patients; Case reference number US-BN-2023-001330 is a spontaneous case report initially received on 01-Aug-2023 from a nurse via agency (reference number: USBAV23-1106) and concerns *three* patients of unknown demographics.  The patients' relevant medical history and concomitant medications were not reported.  *On unspecified dates, three patients received two doses of Jynneos (batch number: unknown), at a dose of 0.1 ml, intradermally (ID), at unknown site of administration for smallpox/monkeypox prophylaxis (explicitly coded as 'intradermal injection').  As reported, six doses of Jynneos vaccine were administered.*  *At the time of this follow up report, it was unknown if three patients experienced any adverse event due to Jynneos vaccination.*  Additional information received from Bavarian Nordic on 02-Aug-2023 included local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from nurse on 16-Aug-2023. New information included number of patients and confirmation that administered Jynneos vaccines to patients were before the previously reported Jynneos temperature excursion and that no patient was given affected Jynneos during the unstable period, so the special situations of '14 doses of Jynneos had excursion every time a new pharmacist come in, Jynneos been administered six times' (explicitly coded as 'product storage error temperature too high' and 'product administration error') were removed.; Reporter's Comments: Three patients of unknown demographics received two doses of Jynneos, 0.1 mL applied intradermally (which is considered intradermal injection), for smallpox/mpox prophylaxis. No associated adverse events or issues were reported. Intradermal injection is considered listed per company convention. Medical history and concomitant medications were unavailable. Intradermal injection is not related to Jynneos, but to human factor. The case is non-serious.; Sender's Comments: Three patients of unknown demographics received two doses of Jynneos, 0.1 mL applied intradermally (which is considered intradermal injection), for smallpox/mpox prophylaxis. No associated adverse events or issues were reported. Intradermal injection is considered listed per company convention. Medical history and concomitant medications were unavailable. Intradermal injection is not related to Jynneos, but to human factor. The case is non-serious.
Age: 23.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Two day expired Jynneos vaccine was administered to patient on 11-Aug-2023, expiration date 08-Aug-2023; Case reference number US-BN-2023-001402 is a spontaneous case report initially received from nurse via Communications (reference number: USBAV23-1225) on 15-Aug-2023 and concerns an adult male.  The patient's medical history and concomitant medication details were not provided.  On 08-Aug-2023, Jynneos vaccine expired.  On 11-Aug-2023, the patient was vaccinated with a dose of expired Jynneos vaccine (batch number: FDP00020; expiration date: Oct-2024), at unknown dose, route and site of administration, for indication reported as Monkeypox vaccine (explicitly coded as 'expired vaccine used'). On the box, expiration date was Oct-2024. The best use date was 08-Aug-2023 and was handwritten. As reported, it was delivered by health department to office at 13-Jun-2023. The reporter taught that must have been the date the vaccine was pulled from frozen storage and then sent.  At the time of initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 17-Aug-2023 included local BN case ID number.; Reporter's Comments: A 23-year-old male patient was vaccinated with a dose of Jynneos (batch FDP00020, best use date 08-Aug-2023), on 11-Aug-2023, three days after the best use date, which is considered expired vaccine used. On the box, expiration date was October 2024. No associated adverse events were reported. Expired vaccine used is considered listed per company convention. Medical history was not reported. Expired vaccine used is considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A 23-year-old male patient was vaccinated with a dose of Jynneos (batch FDP00020, best use date 08-Aug-2023), on 11-Aug-2023, three days after the best use date, which is considered expired vaccine used. On the box, expiration date was October 2024. No associated adverse events were reported. Expired vaccine used is considered listed per company convention. Medical history was not reported. Expired vaccine used is considered not related to Jynneos, but to human error. The case is non-serious.
Sex: M
Vaccine: DTAP, DTAPIPV, HEP, HEPA, MNQ, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: Several Vaccines lost Temperature when the power went out; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of incorrect storage of drug in a male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis, HAV (Havrix) for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Kinrix, Infanrix, Havrix, Rotarix lyophilized formulation, Engerix B, Boostrix and Menveo. On an unknown date, an unknown time after receiving Kinrix, Infanrix, Havrix, Rotarix lyophilized formulation, Engerix B, Boostrix and Menveo, the patient experienced incorrect storage of drug (Verbatim: Several Vaccines lost Temperature when the power went out).  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-SEP-2023 The reporter reported that several vaccines lost temperature when the power went which led to Incorrect storage of drug. The reporter consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pruritus
Clinical narrative: Redness at injection site; Injection site warmth; Injection site swelling; Sorness; itchiness; This non-serious case was reported by a other health professional and described the occurrence of injection site erythema in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EP5FD, expiry date 07-DEC-2024) for prophylaxis.   On 07-SEP-2023, the patient received Arexvy (intramuscular) .5 ml. On 08-SEP-2023, 1 days after receiving Arexvy, the patient experienced injection site erythema (Verbatim: Redness at injection site), injection site warmth (Verbatim: Injection site warmth), injection site swelling (Verbatim: Injection site swelling), pain (Verbatim: Sorness) and pruritus (Verbatim: itchiness). The outcome of the injection site erythema, injection site warmth, injection site swelling, pain and pruritus were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling, pain and pruritus to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site warmth, injection site swelling, pain and pruritus to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter stated after administration of Arexvy vaccine around injection site patient experienced Redness, warmth, and mild swelling. She also had some soreness and itchiness. These symptoms were not treated. The patient was not pregnant. The reported did not consented to follow up.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Condition aggravated, Dyspnoea, General physical health deterioration, Immediate post-injection reaction
Clinical narrative: increase shortness of breath; increase shortness of breath; This non-serious case was reported by a physician via sales rep and described the occurrence of increased shortness of breath in a 71-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included shortness of breath. Concomitant products included prednisone.   On 03-SEP-2023, the patient received Arexvy. On 03-SEP-2023, immediately after receiving Arexvy, the patient experienced increased shortness of breath (Verbatim: increase shortness of breath) and condition aggravated (Verbatim: increase shortness of breath).The outcome of the increased shortness of breath and condition aggravated were not reported.   It was unknown if the reporter considered the increased shortness of breath and condition aggravated to be related to Arexvy.  It was unknown if the company considered the increased shortness of breath and condition aggravated to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-SEP-2023 The patient was administered the Arexvy vaccine (one injection). Shortly after receiving the Arexvy vaccine the patient complained of increase shortness of breath.  The patient was usually on a routine daily dose of 20mg of prednisone and due to his increase in shortness of breath he was increased to 100mg of Prednisone daily.  The doctor was not sure if it was directly related to the Arexvy vaccine but he thought it was a significant change in his health status that he thought it was worth reporting. The reporter agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: RSV
Symptoms: Erythema, Swelling
Clinical narrative: raised bump that looked like a bulls eye/ it was red around the area; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of local swelling in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced local swelling (Verbatim: raised bump that looked like a bulls eye/ it was red around the area).  The outcome of the local swelling was not reported.   It was unknown if the reporter considered the local swelling to be related to Arexvy.     It was unknown if the company considered the local swelling to be related to Arexvy.   Additional Information: GSK receipt date: 11-Sept-2023 The pharmacist reported the patient received a dose of Arexvy and had a raised bump that looked like a bulls eye and it was red around the area. The reporter consented to follow-up. The case had been link to the case US2023AMR124863, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR124863:same drug, same reporter US-GSK-US2023AMR124863:same vaccine, same reporter
Sex: U
Vaccine: RSV
Symptoms: Rash
Clinical narrative: had a rash; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of rash in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced rash (Verbatim: had a rash).  The patient was treated with benadryl (nos) (Benadryl). The outcome of the rash was not reported.   It was unknown if the reporter considered the rash to be related to Arexvy.     It was unknown if the company considered the rash to be related to Arexvy.   Additional Information: GSK Receipt date: 11-SEP-2023 The reporter reported that the patient had a rash after receiving Arexvy and had to take a Benadryl. The reporter consented to follow up. The case had been link to the US2023AMR124853 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR124853:same vaccine, same reporter
Age: 0.25
Sex: M
Vaccine: DTAPIPV, MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The 3 month old patient received a dose of Kinrix and Bexsero; administrator didn't know Kinrix is not approved for children and He didn't know there wasn't a hepatitis B and Hib combination vaccine; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 3-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number 9R42C, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX) and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PCV13).   On 11-SEP-2023, the patient received Kinrix (left thigh) .5 ml and Bexsero (left thigh) .5 ml. On 11-SEP-2023, an unknown time after receiving Kinrix and Bexsero and an unknown time after receiving ROTARIX, the patient experienced inappropriate age at vaccine administration (Verbatim: The 3 month old patient received a dose of Kinrix and Bexsero) and wrong vaccine administered (Verbatim: administrator didn't know Kinrix is not approved for children and He didn't know there wasn't a hepatitis B and Hib combination vaccine).  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: 11-SEP-2023 The office administrator called on behalf of the office to report maladministration of Bexsero to a patient said he did not administer the vaccine.  The patient was at the office for his 2 month visit.  He said the chart did not note any adverse events following administration and the patient was released to go home.  He said they were trying to administer a hepatitis B and Hib vaccine combo and did not realize until later that Bexsero was given. The 3 month old patient also received a dose of Kinrix, when asked for the reason, the office administrator did not know Kinrix was not approved for children.  He did not know there was not a hepatitis B and Hib combination vaccine.  He said that was probably another maladministration since the patient should have received Pentacel or Pediarix. When asked about any adverse events or reactions following Kinrix administration, the Administrator said there were no reports of incidents following either vaccine.  He said they would call Mom to inquire how the infant is doing.  If Mom reported anything, said he would call back to let GSK know. The 3 months old patient received Bexsero and Kinrix, which led inappropriate age at vaccine administration. The patient was suppose to receive Pentacel or Pediarix instead of Kinrix , which led to wrong vaccine administered  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash at injection site; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In SEP-2023, the patient received Shingrix. In SEP-2023, an unknown time after receiving Shingrix, the patient experienced injection site rash (Verbatim: rash at injection site).  The patient was treated with steroids nos (Steroids) and benadryl (nos) (Benadryl). The outcome of the injection site rash was not resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.     It was unknown if the company considered the injection site rash to be related to Shingrix.   Additional Information: GSK receipt date: 12-SEP-2023 The patient received Shingrix vaccine last week. Today (on the day of reporting) the patient came to the office with rash at injection site. The patient was treated with steroids and Benadryl. The medical assistant wanted to know if 2nd dose was appropriate for that patient. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered which is out of date; This non-serious case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administered which is out of date).  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-Sept-2023 The pharmacist had a query with regards to a Bexsero vaccine, to which a general practitioner had administered which was out of date.  The reporter need guidelines to advise on this matter. No further information was available.  Medical Information was emailing directly to safety on 13th September 2023 as it appears this has not yet been forwarded to safety. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Diarrhoea, Fatigue, Pain, Pain in extremity
Clinical narrative: Fatigue; experienced chills; diarrhea; vomiting; pains in arms and legs; Aches; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a 91-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G9577) for prophylaxis.   On 29-AUG-2023, the patient received Arexvy. In AUG-2023, 24 hrs after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue), chills (Verbatim: experienced chills), diarrhea (Verbatim: diarrhea), vomiting (Verbatim: vomiting), pain in arm (Verbatim: pains in arms and legs) and pain (Verbatim: Aches).  The outcome of the fatigue, chills, diarrhea, vomiting, pain in arm and pain were resolved.   It was unknown if the reporter considered the fatigue, chills, diarrhea, vomiting, pain in arm and pain to be related to Arexvy.     It was unknown if the company considered the fatigue, chills, diarrhea, vomiting, pain in arm and pain to be related to Arexvy.   Additional Information: GSK Receipt date: 12-SEP-2023 A pharmacist reported that no other vaccines administered that day.  The patient experienced chills, fatigue, diarrhea, vomiting, aches and pains in arms and legs onset 24 hours after vaccination. The symptoms persisted for between 48 and 72 hours after onset of symptoms. The reporter agrees to follow up from GSK.
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: Vomiting
Clinical narrative: Fatigue; experienced chills; diarrhea; vomiting; pains in arms and legs; Aches; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a 91-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G9577) for prophylaxis.   On 29-AUG-2023, the patient received Arexvy. In AUG-2023, 24 hrs after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue), chills (Verbatim: experienced chills), diarrhea (Verbatim: diarrhea), vomiting (Verbatim: vomiting), pain in arm (Verbatim: pains in arms and legs) and pain (Verbatim: Aches).  The outcome of the fatigue, chills, diarrhea, vomiting, pain in arm and pain were resolved.   It was unknown if the reporter considered the fatigue, chills, diarrhea, vomiting, pain in arm and pain to be related to Arexvy.     It was unknown if the company considered the fatigue, chills, diarrhea, vomiting, pain in arm and pain to be related to Arexvy.   Additional Information: GSK Receipt date: 12-SEP-2023 A pharmacist reported that no other vaccines administered that day.  The patient experienced chills, fatigue, diarrhea, vomiting, aches and pains in arms and legs onset 24 hours after vaccination. The symptoms persisted for between 48 and 72 hours after onset of symptoms. The reporter agrees to follow up from GSK.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st received more than 6 months ago).   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: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2023 A pharmacist called to ask for information about patient who received the first dose of Shingrix more than 6 months ago. The Healthcare professional asked if the patient need to restart the series. The reporter did not provide information about the patient. The reporter consented to follow up. This case was one of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR127219:same reporter, patient 3 of 3 US-GSK-US2023124590:Same reporter, patient 1of 3
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st received more than 6 months ago).   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: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2023 A pharmacist called to ask for information about patient who received the first dose of Shingrix more than 6 months ago. The Healthcare professional asked if the patient need to restart the series. The reporter did not provide information about the patient. The reporter consented to follow up. This case was one of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023124590:Same reporter, patient 1 of 3 US-GSK-US2023AMR127218:same reporter, patient 2 of 3
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: her arm was sore from the injection site all the way up to her neck for 2-3 days; all the way up to her neck; This non-serious case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: her arm was sore from the injection site all the way up to her neck for 2-3 days) and neck pain (Verbatim: all the way up to her neck).  The outcome of the pain in arm and neck pain were resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm and neck pain to be related to Shingrix.     It was unknown if the company considered the pain in arm and neck pain to be related to Shingrix.   Additional Information: GSK receipt date: 13-Sept-2023 The health care professional shared that she own experienced after having received Shingrix dose, her arm was sore from the injection site all the way up to her neck for 2 to 3 days. The reporter did not consent to follow-up.
Sex: U
Vaccine: RVX
Symptoms: Diarrhoea, Erythema, Illness, Pain, Pain in extremity
Clinical narrative: red; hurts; very sick; terrible diarrhea; feeling nauseous; arm still hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced erythema (Verbatim: red), pain (Verbatim: hurts), sickness (Verbatim: very sick), diarrhea (Verbatim: terrible diarrhea), nausea (Verbatim: feeling nauseous) and pain in arm (Verbatim: arm still hurts).  The outcome of the erythema, pain, sickness, diarrhea and nausea were resolving and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the erythema, pain, sickness, diarrhea, nausea and pain in arm to be related to RSV vaccine.     It was unknown if the company considered the erythema, pain, sickness, diarrhea, nausea and pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 13-Sept-2023 The case was received from the patient via interactive digital media. The patient got RSV shot Wednesday and had red and hurts. The patient was very sick on Thursday with terrible diarrhea and feeling nauseous. On Friday the patient felt better but arm still hurts.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patients haven't completed the 2 dose series; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patient's who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 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: Patients haven't completed the 2 dose series).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2022 The reporter reported that the physician was interested in the efficacy data with just one dose of Shingrix vaccine. The reporter stated that the patients had not completed the 2 doses of series. Till the time of reporting, the patients did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received second dose of Shingrix 2 weeks apart from the first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Received second dose of Shingrix 2 weeks apart from the first dose).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2022 The reporter was a nurse from a Medical Clinic. The reporter reported that the patient received second dose of Shingrix two weeks apart from the first dose.  No other information was provided about this event. The patient received 2nd dose of Shingrix, early than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Incorrect route of product administration
Clinical narrative: Arexvy - Subcutaneous instead of Intramuscular injection; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (subcutaneous). On an unknown date, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: Arexvy - Subcutaneous instead of Intramuscular injection).The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2023 The healthcare professional called to report the subcutaneous administration of Arexvy to a patient, which led to intramuscular formulation administered by other route. The healthcare professional asked if the dose should be repeated.  The reporter did not provide information about patient (patient initials, age, gender). Due to the nature of the call permission to follow up was not requested.
Sex: M
Vaccine: RSV
Symptoms: Chest X-ray normal, Dizziness, Fatigue, Laboratory test normal, Pain
Clinical narrative: Felt fatigue; Body aches; Coughing up a little mucous; Dizzy feeling/ light-headed; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-SEP-2023, the patient received Arexvy (intramuscular, left arm). On 09-SEP-2023, 20 min after receiving Arexvy, the patient experienced dizziness (Verbatim: Dizzy feeling/ light-headed). On 10-SEP-2023, the patient experienced fatigue (Verbatim: Felt fatigue), general body pain (Verbatim: Body aches) and productive cough (Verbatim: Coughing up a little mucous).  On 09-SEP-2023, the outcome of the dizziness was resolved (duration 10 min).  On 11-SEP-2023, the outcome of the productive cough was resolved (duration 1 day). The outcome of the fatigue and general body pain were not resolved.   It was unknown if the reporter considered the fatigue, general body pain, dizziness and productive cough to be related to Arexvy.     It was unknown if the company considered the fatigue, general body pain, dizziness and productive cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-SEP-2022/ 12-SEP-2023 The patient was self-reported this case. The patient reported that he received Arexvy vaccine and 20 minutes after received vaccine experienced light headed and felt dizzy. The patient sat in his truck for about 10 minutes and the light headed and feeling dizzy was resolved. The patient that on the next day 10th September 2023 he felt fatigue, body aches, and coughing up a little mucous.  The coughing of the mucous resolved 11th September 2023 but the fatigue and body aches are still present. The reporter reported that the patient went to the emergency department and two tests were performed both with negative results. The patient wanted safety to contact him directly so he can send the records from the emergency department. The reporter did not consent to follow up.
Sex: M
Vaccine: RSV
Symptoms: Productive cough, SARS-CoV-2 test negative, Secretion discharge
Clinical narrative: Felt fatigue; Body aches; Coughing up a little mucous; Dizzy feeling/ light-headed; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-SEP-2023, the patient received Arexvy (intramuscular, left arm). On 09-SEP-2023, 20 min after receiving Arexvy, the patient experienced dizziness (Verbatim: Dizzy feeling/ light-headed). On 10-SEP-2023, the patient experienced fatigue (Verbatim: Felt fatigue), general body pain (Verbatim: Body aches) and productive cough (Verbatim: Coughing up a little mucous).  On 09-SEP-2023, the outcome of the dizziness was resolved (duration 10 min).  On 11-SEP-2023, the outcome of the productive cough was resolved (duration 1 day). The outcome of the fatigue and general body pain were not resolved.   It was unknown if the reporter considered the fatigue, general body pain, dizziness and productive cough to be related to Arexvy.     It was unknown if the company considered the fatigue, general body pain, dizziness and productive cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-SEP-2022/ 12-SEP-2023 The patient was self-reported this case. The patient reported that he received Arexvy vaccine and 20 minutes after received vaccine experienced light headed and felt dizzy. The patient sat in his truck for about 10 minutes and the light headed and feeling dizzy was resolved. The patient that on the next day 10th September 2023 he felt fatigue, body aches, and coughing up a little mucous.  The coughing of the mucous resolved 11th September 2023 but the fatigue and body aches are still present. The reporter reported that the patient went to the emergency department and two tests were performed both with negative results. The patient wanted safety to contact him directly so he can send the records from the emergency department. The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness
Clinical narrative: Dizziness; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-SEP-2023, the patient received Arexvy. On 05-SEP-2023, 1 hr after receiving Arexvy, the patient experienced dizziness (Verbatim: Dizziness).  The outcome of the dizziness was not resolved.   It was unknown if the reporter considered the dizziness to be related to Arexvy.     It was unknown if the company considered the dizziness to be related to Arexvy.   Additional Information: GSK receipt date: 11-Sept-2023 and 12-Sept-2023 The patient stated that she received Arexvy vaccine around 2 pm and 1 hour later she started feeling dizzy.  According to reporter, she still had the dizziness and she tried contacting her physician last week on Friday without success.  The patient was very good unfortunately all they were doing was filing a report and she was hoping that she could have more information on having dizziness from this RSV shot and did not know she had called the physician and have not gotten anything back so she will check again. Reporter would like to be contacted by the safety team regarding this concern.  The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient has not received the 2nd dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received intramuscularly on 21st November 2021 with unknown batch number and expiry 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: Patient has not received the 2nd dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2022 The reporter reported that the patient had not received the 2nd dose of Shingrix vaccine.  No additional information was provided. The reporter inquiries about if the series should be started again or if the 2nd dose should be administered now.  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingrix: Episode of Shingles after 1st dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received 15 years ago).   On 18-NOV-2021, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingrix: Episode of Shingles after 1st dose of Shingrix).  The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 11-SEP-2023 The pharmacist had several questions on Shingrix. The patient got first dose of Shingrix but never came for the 2nd dose. The patient also developed 2 bouts of shingles (date unknown) after the first dose of Shingrix. The call was transferred by agency- product agent Via phone, agent mentioned that the AE for late 2nd dose was collected and was transferred to MI.  During conversation with the provider the MI agent noted that HCP mentioned the patient had 2 bouts of shingles (date unknown) after first dose of Shingrix as well so the the above AE- was filed as MI agent believes this was not told to agency -product agent and could have been missed in the AE form filed by the agent.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not receievd 2nd dose 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st received more than 6 months ago).   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: not receievd 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2023 A pharmacist called to ask for information about patient who received the first dose of Shingrix more than 6 months ago. The Healthcare professional asked if the patient need to restart the series. The reporter did not provide information about the patient. The reporter consented to follow up. This case was one of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR127218:Same reporter, Patient 2 of 3 US-GSK-US2023AMR127219:Same reporter, Patient 3 of 3
Age: 71.0
Sex: M
Vaccine: HEPAB
Symptoms: Interchange of vaccine products, Wrong product administered
Clinical narrative: interchange of vaccines; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 71-year-old male patient who received HAB (Twinrix) (batch number 2PG39, expiry date 19-SEP-2025) for prophylaxis.   Previously administered products included Havrix (on 2nd February 2023, received a dose.).   On 03-AUG-2023, the patient received Twinrix. On 03-AUG-2023, an unknown time after receiving Twinrix, the patient experienced wrong vaccine administered (Verbatim: interchange of vaccines).  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: 11-SEP-2023 The pharmacist reported a patient got a dose of Havrix on 02nd February 2023, then Twinrix was given 03rd August 2023. The vaccine administration facility was the same as primary reporter. The patient received Twinrix after Havrix, which led to wrong vaccine administration. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose given 25 days after dose 1; 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 adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Second dose given 25 days after dose 1). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2022 The reporter reported that the patient over 50 years of age inadvertently received second dose of Shingrix vaccine 25 days after received first dose. The reporter did not provided consent to capture his contact details and declined permission for follow up.  The reporter did not had exact dates of administration available, and did not had patient date of birth or age, stating that the patient was over 50 but no further details were available at the time of the reporting. The patient received 2nd dose of Shingrix, early than the recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received second dose for Twinrix today 9/11/2023, 3 months apart from the first dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix adult (1st dose received on 5th June 2023).   On 11-SEP-2023, the patient received the 2nd dose of Twinrix adult. On 11-SEP-2023, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: received second dose for Twinrix today 9/11/2023, 3 months apart from the first dose).  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: 11-SEP-2022 The patient was self-reported this case. The patient reported that she received second dose of Twinrix adult vaccine 3 months apart from the first dose due to travelling out of the country. The patient received 2nd dose of Twinrix adult, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: itching was everywhere; Rash/she has a patient that developed a rash/rash is red everywhere; Discomfort; Bumpy rash; This non-serious case was reported by a physician via call center representative and described the occurrence of generalized pruritus in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced generalized pruritus (Verbatim: itching was everywhere), red rash (Verbatim: Rash/she has a patient that developed a rash/rash is red everywhere), discomfort (Verbatim: Discomfort) and papular rash (Verbatim: Bumpy rash). The patient was treated with cetirizine hydrochloride (Zyrtec), famotidine (Pepcid) and fexofenadine hydrochloride (Allegra). The outcome of the generalized pruritus, red rash, discomfort and papular rash were not resolved.   The reporter considered the generalized pruritus, red rash, discomfort and papular rash to be related to Shingrix.     The company considered the generalized pruritus, red rash, discomfort and papular rash to be related to Shingrix.   Additional Information: GSK receipt date: 11-SEP-2023 and 13-SEP-2023 The reporter was a physician.  The physician stated she had a patient that developed a rash and itching after first Shingrix dose, that was initially on her back and back of legs, but now a week later, the rash and itching was everywhere.  The rash was red, raised and bumpy.  Reaction included skin itching, rash and discomfort. The patient was already on Zyrtec, Pepcid and steroid burst, the physician now was adding Allegra. No further details were collected because call had to be transferred from GlaxoSmithKline (GSK) response Center to GSK Medical Information. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administration of Kinrix to a 51 y/o patient instead of Boostrix; administration of Kinrix to a 51 y/o patient; 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 51-year-old male patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 24-AUG-2023, the patient received Kinrix. On 24-AUG-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: administration of Kinrix to a 51 y/o patient instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: administration of Kinrix to a 51 y/o patient).  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: 11-Sept-2023  The case was received from the medical assistant. The patient received a dose of Kinrix instead of Boostrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.