chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: NO ADDITIONAL ADVERSE EVENTS; Medical assistant reported AE related to VARIVAX. Reported patient received only half of the dose, due to moving during administration. No additional AE/no PQC.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #X002100, expiration date: 19-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   It was reported that, on that day, the patient received only half of the dose, due to moving during administration (Vaccine underdose). No additional adverse events were reported.
Age: 23.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE; patient given Gardasil 9 u008316 exp 8/15/2023 given on 8/24/2023; This spontaneous report was received from an office manager referring to a 23-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 24-AUG-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis (dose frequency: one time, lot#: u008316, expiration date: 15-AUG-2023, product circular number: 090143508a08bf3f; strength, dose, and route of administration were not reported) (expired product administered). Per the post expiry memo, the vaccine was supported.  No reaction. No further adverse events (AE) were reported (no adverse event).
Age: 72.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Contusion, Lymphadenopathy
Clinical narrative: Left lymph nodes are swollen and bruised down to my breasts
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Rt deltoid Red, Swollen, Hot to touch and hard
Age: 18.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient has not reported any symptoms; Caller stated on 6/9 18-year-old patient received adult dose of vaccine. on 8/1 patient then received adolescent dose of VAQTA; Caller stated on 6/9 18-year-old patient received adult dose of vaccine. on 8/1 patient then received adolescent dose of VAQTA; This spontaneous report was received from a nurse and refers to an 18-year-old patient. he patient's medical history, concurrent conditions and concomitant medications were not reported.  On 09-JUN-2023, the patient was vaccinated with adult dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, first dose, administered for prophylaxis (anatomical location, lot #, expiry date, and route of administration were not provided).  On 01-AUG-2023, the patient was vaccinated with adolescent dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, second dose, lot #W028824, expiration date: 07-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age, inappropriate dose of vaccine administered).  The patient has not reported any symptoms (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Nurse reported ROTATEQ was administered after improper storage. Requested follow up letter be sent to different RN, as reporter is covering for clinic currently. See additional AE cases 02453315, 02453385, 02453409, 02453432, 02453446, 02453464, and; This spontaneous report was received from a Registered Nurse referred to a specific patient of unknown age and gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On 06-JUL-2023, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1908339, 18-NOV-2023, orally, (strength, dose number, and frequency were not reported) as prophylaxis (product storage error). The vaccine experience a temperature excursion of 51 Fahrenheit Degrees during one hour. The vaccine had no previous excursions.          This is one of several reports from the same reporter.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No additional AE reported; she had an adult patient that had her first dose of a hepatitis b vaccine in 2015 and no additional hep b vaccine since then; This spontaneous report has been received from a registered pharmacist, referring to an adult female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   In 2015, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (reported as it could not be confirmed the name brand of the original vaccine) (route, dose, strength, lot number and expiration date) for prophylaxis and no additional hepatitis b vaccine since then (incomplete course of vaccination). No additional adverse event reported.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC. No symptoms/adverse events reported; an adult dose of VAQTA was inadvertently given to a 17 year old patient.; Adult and pediatric doses look very similar.; This spontaneous report has been received from a registered nurse, referring to a 17 years old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   On 09-AUG-2023, the patient was vaccinated with the first dose of an adult dose (1 dosage form) inadvertently of hepatitis a vaccine, inactivated (VAQTA) 50/1.0 U/ml (expiration date: 10-JUL-2024) intramuscularly for prophylaxis (incorrect dose administered). It was reported that adult pediatric doses looked very similar (product dose confusion). No symptoms/adverse events were reported.  Lot # w02855A was evaluated and changed to the valid Lot # W028554 valid for hepatitis a vaccine, inactivated (VAQTA) (formulation prefilled syringe).
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MNQ, MNQ
Symptoms: Computerised tomogram head, Culture positive, Endoscopy abnormal, Haemophilus test positive, Meningitis meningococcal
Clinical narrative: suspected vaccination failure; Neisseria meningitidis; congestion; Sinusitis; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 19-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.  Co-suspect products included Men B NVS (Bexsero) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and MENACTRA for prophylaxis.   The patient's past medical history included chronic allergic rhinosinusitis and functional endoscopic sinus surgery (FESS occurred 3.5 months prior to diagnostic visit).   On an unknown date, the patient received the 1st dose of Bexsero, the 2nd dose of Bexsero, Menveo and the 1st dose of MENACTRA. On an unknown date, an unknown time after receiving Bexsero, Bexsero and Menveo, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), neisseria meningitides meningitis (Verbatim: Neisseria meningitidis) (serious criteria GSK medically significant), nasal congestion (Verbatim: congestion) and sinusitis (Verbatim: Sinusitis). The patient was treated with cefdinir. The outcome of the vaccination failure was unknown and the outcome of the neisseria meningitides meningitis, nasal congestion and sinusitis were resolved.   The reporter considered the vaccination failure, neisseria meningitides meningitis, nasal congestion and sinusitis to be related to Bexsero, Bexsero and Menveo. It was unknown if the reporter considered the vaccination failure, neisseria meningitides meningitis, nasal congestion and sinusitis to be related to Meningococcal B Vaccine Pre-Filled Syringe Device and Meningococcal B Vaccine Pre-Filled Syringe Device.   The company considered the vaccination failure, neisseria meningitides meningitis, nasal congestion and sinusitis to be related to Bexsero, Bexsero and Menveo. It was unknown if the company considered the vaccination failure, neisseria meningitides meningitis, nasal congestion and sinusitis to be related to Meningococcal B Vaccine Pre-Filled Syringe Device and Meningococcal B Vaccine 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: 25-AUG-2023  This case corresponds to 19-year-old female patient mentioned in the literature article.  A patient with a history of chronic rhinosinusitis status after bilateral FESS 3 months prior presented with 1 week of congestion. Patient was an undergraduate collegiate student-athlete and member of the varsity track and field team. Sinonasal endoscopy and cultures returned positive for Neisseria meningitidis and patient was started on cefdinir with resolution of symptoms. Patient completed both the MenACWY and MenB series prior to the initial infection.  This case has been considered as suspected vaccination failure as the time to onset was unknown.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MNQ, MNQ
Symptoms: Nasal congestion, Nasoendoscopy, Neisseria test positive, Sinusitis, Staphylococcus test positive
Clinical narrative: suspected vaccination failure; Neisseria meningitidis; congestion; Sinusitis; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 19-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.  Co-suspect products included Men B NVS (Bexsero) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and MENACTRA for prophylaxis.   The patient's past medical history included chronic allergic rhinosinusitis and functional endoscopic sinus surgery (FESS occurred 3.5 months prior to diagnostic visit).   On an unknown date, the patient received the 1st dose of Bexsero, the 2nd dose of Bexsero, Menveo and the 1st dose of MENACTRA. On an unknown date, an unknown time after receiving Bexsero, Bexsero and Menveo, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), neisseria meningitides meningitis (Verbatim: Neisseria meningitidis) (serious criteria GSK medically significant), nasal congestion (Verbatim: congestion) and sinusitis (Verbatim: Sinusitis). The patient was treated with cefdinir. The outcome of the vaccination failure was unknown and the outcome of the neisseria meningitides meningitis, nasal congestion and sinusitis were resolved.   The reporter considered the vaccination failure, neisseria meningitides meningitis, nasal congestion and sinusitis to be related to Bexsero, Bexsero and Menveo. It was unknown if the reporter considered the vaccination failure, neisseria meningitides meningitis, nasal congestion and sinusitis to be related to Meningococcal B Vaccine Pre-Filled Syringe Device and Meningococcal B Vaccine Pre-Filled Syringe Device.   The company considered the vaccination failure, neisseria meningitides meningitis, nasal congestion and sinusitis to be related to Bexsero, Bexsero and Menveo. It was unknown if the company considered the vaccination failure, neisseria meningitides meningitis, nasal congestion and sinusitis to be related to Meningococcal B Vaccine Pre-Filled Syringe Device and Meningococcal B Vaccine 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: 25-AUG-2023  This case corresponds to 19-year-old female patient mentioned in the literature article.  A patient with a history of chronic rhinosinusitis status after bilateral FESS 3 months prior presented with 1 week of congestion. Patient was an undergraduate collegiate student-athlete and member of the varsity track and field team. Sinonasal endoscopy and cultures returned positive for Neisseria meningitidis and patient was started on cefdinir with resolution of symptoms. Patient completed both the MenACWY and MenB series prior to the initial infection.  This case has been considered as suspected vaccination failure as the time to onset was unknown.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MNQ, MNQ
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination failure; Neisseria meningitidis; congestion; Sinusitis; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 19-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.  Co-suspect products included Men B NVS (Bexsero) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and MENACTRA for prophylaxis.   The patient's past medical history included chronic allergic rhinosinusitis and functional endoscopic sinus surgery (FESS occurred 3.5 months prior to diagnostic visit).   On an unknown date, the patient received the 1st dose of Bexsero, the 2nd dose of Bexsero, Menveo and the 1st dose of MENACTRA. On an unknown date, an unknown time after receiving Bexsero, Bexsero and Menveo, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), neisseria meningitides meningitis (Verbatim: Neisseria meningitidis) (serious criteria GSK medically significant), nasal congestion (Verbatim: congestion) and sinusitis (Verbatim: Sinusitis). The patient was treated with cefdinir. The outcome of the vaccination failure was unknown and the outcome of the neisseria meningitides meningitis, nasal congestion and sinusitis were resolved.   The reporter considered the vaccination failure, neisseria meningitides meningitis, nasal congestion and sinusitis to be related to Bexsero, Bexsero and Menveo. It was unknown if the reporter considered the vaccination failure, neisseria meningitides meningitis, nasal congestion and sinusitis to be related to Meningococcal B Vaccine Pre-Filled Syringe Device and Meningococcal B Vaccine Pre-Filled Syringe Device.   The company considered the vaccination failure, neisseria meningitides meningitis, nasal congestion and sinusitis to be related to Bexsero, Bexsero and Menveo. It was unknown if the company considered the vaccination failure, neisseria meningitides meningitis, nasal congestion and sinusitis to be related to Meningococcal B Vaccine Pre-Filled Syringe Device and Meningococcal B Vaccine 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: 25-AUG-2023  This case corresponds to 19-year-old female patient mentioned in the literature article.  A patient with a history of chronic rhinosinusitis status after bilateral FESS 3 months prior presented with 1 week of congestion. Patient was an undergraduate collegiate student-athlete and member of the varsity track and field team. Sinonasal endoscopy and cultures returned positive for Neisseria meningitidis and patient was started on cefdinir with resolution of symptoms. Patient completed both the MenACWY and MenB series prior to the initial infection.  This case has been considered as suspected vaccination failure as the time to onset was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This non-serious case was reported by a consumer and described the occurrence of tinnitus in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 74FB9, expiry date 30-NOV-2023) for prophylaxis.   Concomitant products included hydrochlorothiazide and testosterone (Testim).   On 24-OCT-2022, the patient received Shingrix .5 ml. On 25-OCT-2022, 1 days after receiving Shingrix, the patient experienced tinnitus (Verbatim: Tinnitus).  The outcome of the tinnitus was not resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.     It was unknown if the company considered the tinnitus to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-AUG-2023 The patient reported that he received Shingrix vaccine and experienced tinnitus. The reporter stated that the symptoms was did not treated. The reporter did consent to follow up via email.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB, MNQ, RV1
Symptoms: Product storage error
Clinical narrative: had a temperature excursion for 160 hours during which they could have reached temperatures beyond the maximum permitted.; This non-serious case was reported by a physician via call center representative and described the occurrence of intercepted product storage error in a an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient did not receive Rotarix lyophilized formulation, Bexsero, Menveo, Engerix B, Havrix, Kinrix, Infanrix and Pediarix. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, Bexsero, Menveo, Engerix B, Havrix, Kinrix, Infanrix and Pediarix, the patient experienced intercepted product storage error (Verbatim: had a temperature excursion for 160 hours during which they could have reached temperatures beyond the maximum permitted.).  The outcome of the intercepted product storage error 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:24-AUG-2023 The health care professional called to inform that Bexsero, Engerix-B, Havrix, Infanrix, Kinrix, Menveo (2-vial), Pediarix, Rotarix (Liquid presentation) had a temperature excursion for 160 hours during which they could have reached temperatures beyond the maximum permitted. Due to technical limitations in the system, they could not ensure the vaccines were viable, so they had to be discarded, which led to Intercepted product storage error.  Prior to this decision, some vaccines were administered to patients. At the moment of the call health care professional did not have a number of patients or the vaccines they were given. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. This case has been linked to the case US2023AMR119110 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR119110:
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: some soreness at the injection site/pain at injection site; Last night I think I had some low-grade fever/fever; Last night I think I had sweats/sweats; This non-serious case was reported by a physician via interactive digital media and described the occurrence of injection site pain in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 21-AUG-2023, the patient received the 1st dose of Arexvy. On 22-AUG-2023, 1 days after receiving Arexvy, the patient experienced injection site pain (Verbatim: some soreness at the injection site/pain at injection site), fever (Verbatim: Last night I think I had some low-grade fever/fever) and sweating (Verbatim: Last night I think I had sweats/sweats).  On 23-AUG-2023, the outcome of the fever and sweating were resolved (duration 1 day). The outcome of the injection site pain was not resolved.   The reporter considered the injection site pain, fever and sweating to be possibly related to Arexvy.     The company considered the injection site pain, fever and sweating to be possibly related to Arexvy.   Additional Information: GSK Receipt date: 22-AUG-2023 and 23-AUG-2023 This case was reported by a patient (physician) via interactive digital media. The patient stated that 20-hour post-vaccination update, not bad at all, some soreness at the injection site. The patient stated that last night had some low-grade fever, sweats, about 30 hours after the shot/jab.  The patient stated that he feels fine this morning. Just wanted to disclose that for full transparency.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Nausea, Paraesthesia
Clinical narrative: severe red, 1/2 of upper  arm upper arm; fever; chills; nauseated; headaches; tingling  4-5 days duration; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: severe red, 1/2 of upper  arm upper arm), fever (Verbatim: fever), chills (Verbatim: chills), nausea (Verbatim: nauseated), headache (Verbatim: headaches) and tingling (Verbatim: tingling  4-5 days duration).  The outcome of the erythema of extremities, fever, chills, nausea and headache were not reported and the outcome of the tingling was resolved (duration 5 days).   It was unknown if the reporter considered the erythema of extremities, fever, chills, nausea, headache and tingling to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, fever, chills, nausea, headache and tingling to be related to Shingrix.   Additional Information: GSK Receipt date: 22-AUG-2023 The patient's age was reported as approximately 53 years. A physician reported that a patient received dose 2 and 1 day later had severe red, 1/2 of upper arm upper arm, fever, chills, nauseated, headaches, tingling 4 to 5 days duration. Had not spoken with her to determine outcome. The reporter agrees to follow up from GSK by email.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: severe red, 1/2 of upper  arm upper arm; fever; chills; nauseated; headaches; tingling  4-5 days duration; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: severe red, 1/2 of upper  arm upper arm), fever (Verbatim: fever), chills (Verbatim: chills), nausea (Verbatim: nauseated), headache (Verbatim: headaches) and tingling (Verbatim: tingling  4-5 days duration).  The outcome of the erythema of extremities, fever, chills, nausea and headache were not reported and the outcome of the tingling was resolved (duration 5 days).   It was unknown if the reporter considered the erythema of extremities, fever, chills, nausea, headache and tingling to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, fever, chills, nausea, headache and tingling to be related to Shingrix.   Additional Information: GSK Receipt date: 22-AUG-2023 The patient's age was reported as approximately 53 years. A physician reported that a patient received dose 2 and 1 day later had severe red, 1/2 of upper arm upper arm, fever, chills, nauseated, headaches, tingling 4 to 5 days duration. Had not spoken with her to determine outcome. The reporter agrees to follow up from GSK by email.
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7 year old patient accidentally received a dose of TDaP; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number U7549AA) for prophylaxis.   On 25-JUL-2023, the patient received Boostrix. On 25-JUL-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 7 year old patient accidentally received a dose of TDaP).  The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 22-Aug-2023 Pediatrician called in to report that a 7 year old patient accidentally received a dose of TDaP but was unsure if the product was actually a GSK product. During the call, the conversation was suspended due to a connectivity issue A call back was made but the health care professional (HCP) did not answer. The 7 year old patient Boostrix, which led to inappropriate age at vaccine administered. The reporter consented to follow up.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, Product administered to patient of inappropriate age, Product preparation issue, Wrong technique in product usage process
Clinical narrative: mixed Boostrix with either or vacricella vaccine or MMR vaccine; mixed Boostrix with either or vacricella vaccine or MMR vaccine; 7 years old patient received mixed Boostrix with either or vacricella vaccine or MMR vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong technique in drug usage process in a 7-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong technique in drug usage process (Verbatim: mixed Boostrix with either or vacricella vaccine or MMR vaccine), inappropriate preparation of medication (Verbatim: mixed Boostrix with either or vacricella vaccine or MMR vaccine) and inappropriate age at vaccine administration (Verbatim: 7 years old patient received mixed Boostrix with either or vacricella vaccine or MMR vaccine).The outcome of the wrong technique in drug usage process, inappropriate preparation of medication and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 22-AUG-2023 The reporter stated that nurse thought that she mixed Boostrix with either or varicella vaccine or MMR vaccine (medication error) and administered to 7 years old patient, which led to wrong technique in drug usage process, inappropriate preparation of medication and inappropriate age at vaccine administration.  No further information was known. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pediatric patient received an adult dose of Havrix; pediatric patient received an adult dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 11-year-old female patient who received HAV (Havrix adult) (batch number 9SDB2, expiry date 13-DEC-2024) for prophylaxis.   On 21-AUG-2023, the patient received the 1st dose of Havrix adult. On 21-AUG-2023, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: pediatric patient received an adult dose of Havrix) and overdose (Verbatim: pediatric patient received an adult dose of Havrix).  The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 22-AUG-2023 The nurse had a pediatric patient who received an adult dose of Havrix the day before reporting which led to adult product administered to child and overdose. The nurse stated that it was the first dose and what would be the next step. The reporter consented to follow up. This case is linked with US2023114116, same reporter.; Sender's Comments:  US-GSK-US2023114116:2 patient (siblings)
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: dose was the 6th of the series; an 11-year-old patient received a dose of Infanrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 7C9NJ, expiry date 02-NOV-2024) for prophylaxis.   On 16-MAY-2023, the patient received Infanrix. On 16-MAY-2023, an unknown time after receiving Infanrix, the patient experienced extra dose administered (Verbatim: dose was the 6th of the series) and inappropriate age at vaccine administration (Verbatim: an 11-year-old patient received a dose of Infanrix).  The outcome of the extra dose 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: 22-Aug-2023 The pharmacist called to inform that an 11-year-old patient received a dose of Infanrix on, which led to inappropriate age at vaccine administration.  According to the reporter the dose was the 6th of the series, which led to extra dose administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late second 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 adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received few years 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: Late second dose of shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-Aug-2023 A pharmacist called in to report that a patient over 50 years of age wished to know how to proceed. Information about the event, vaccine and patient was scarce and was not provided as the provider mentioned they had not received consent from the patient. The provider stated that they had previously spoken to an agent but the call dropped and never got a call back. Did not consent to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary mass, Bone pain, Diarrhoea, Dizziness
Clinical narrative: large lump axillary area same side as vaccine (left deltoid); rash on his left arm near the site of the vaccination and moving down his arm,; fatigue; dizziness; diarrhea; fever; bone/joint pain; he began experiencing a headache; This non-serious case was reported by a nurse via call center representative and described the occurrence of axillary lump in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 17-AUG-2023, 1 days after receiving Shingrix, the patient experienced axillary lump (Verbatim: large lump axillary area same side as vaccine (left deltoid)), rash (Verbatim: rash on his left arm near the site of the vaccination and moving down his arm,), fatigue (Verbatim: fatigue), dizziness (Verbatim: dizziness), diarrhea (Verbatim: diarrhea), fever (Verbatim: fever), joint pain (Verbatim: bone/joint pain) and headache (Verbatim: he began experiencing a headache).  The outcome of the axillary lump, fatigue, dizziness and headache were not resolved and the outcome of the rash and fever were resolved and the outcome of the diarrhea and joint pain were resolving.   It was unknown if the reporter considered the axillary lump, rash, fatigue, dizziness, diarrhea, fever, joint pain and headache to be related to Shingrix.     It was unknown if the company considered the axillary lump, rash, fatigue, dizziness, diarrhea, fever, joint pain and headache to be related to Shingrix.   Additional Information: GSK Receipt date: 22-AUG-2023 A nurse practitioner reported that her patient received a Shingrix vaccination and the next day he began experiencing a headache, bone/joint pain, fever, diarrhea, a rash on his left arm near the site of the vaccination and moving down his arm, dizziness and fatigue.  On 17th August 2023 he noticed a large lump under his axillary area of his left arm measuring 8 cm x 9 cm.  The rash and fever had resolved, and the joint pain had decreased, and the diarrhea had improved, but as of today (reporting day), the other symptoms remain. She had drawn CBC and CMP today and plans an Ultrasound to the lump.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Full blood count, Headache, Metabolic function test, Pyrexia
Clinical narrative: large lump axillary area same side as vaccine (left deltoid); rash on his left arm near the site of the vaccination and moving down his arm,; fatigue; dizziness; diarrhea; fever; bone/joint pain; he began experiencing a headache; This non-serious case was reported by a nurse via call center representative and described the occurrence of axillary lump in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 17-AUG-2023, 1 days after receiving Shingrix, the patient experienced axillary lump (Verbatim: large lump axillary area same side as vaccine (left deltoid)), rash (Verbatim: rash on his left arm near the site of the vaccination and moving down his arm,), fatigue (Verbatim: fatigue), dizziness (Verbatim: dizziness), diarrhea (Verbatim: diarrhea), fever (Verbatim: fever), joint pain (Verbatim: bone/joint pain) and headache (Verbatim: he began experiencing a headache).  The outcome of the axillary lump, fatigue, dizziness and headache were not resolved and the outcome of the rash and fever were resolved and the outcome of the diarrhea and joint pain were resolving.   It was unknown if the reporter considered the axillary lump, rash, fatigue, dizziness, diarrhea, fever, joint pain and headache to be related to Shingrix.     It was unknown if the company considered the axillary lump, rash, fatigue, dizziness, diarrhea, fever, joint pain and headache to be related to Shingrix.   Additional Information: GSK Receipt date: 22-AUG-2023 A nurse practitioner reported that her patient received a Shingrix vaccination and the next day he began experiencing a headache, bone/joint pain, fever, diarrhea, a rash on his left arm near the site of the vaccination and moving down his arm, dizziness and fatigue.  On 17th August 2023 he noticed a large lump under his axillary area of his left arm measuring 8 cm x 9 cm.  The rash and fever had resolved, and the joint pain had decreased, and the diarrhea had improved, but as of today (reporting day), the other symptoms remain. She had drawn CBC and CMP today and plans an Ultrasound to the lump.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Vaccination site rash
Clinical narrative: large lump axillary area same side as vaccine (left deltoid); rash on his left arm near the site of the vaccination and moving down his arm,; fatigue; dizziness; diarrhea; fever; bone/joint pain; he began experiencing a headache; This non-serious case was reported by a nurse via call center representative and described the occurrence of axillary lump in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 17-AUG-2023, 1 days after receiving Shingrix, the patient experienced axillary lump (Verbatim: large lump axillary area same side as vaccine (left deltoid)), rash (Verbatim: rash on his left arm near the site of the vaccination and moving down his arm,), fatigue (Verbatim: fatigue), dizziness (Verbatim: dizziness), diarrhea (Verbatim: diarrhea), fever (Verbatim: fever), joint pain (Verbatim: bone/joint pain) and headache (Verbatim: he began experiencing a headache).  The outcome of the axillary lump, fatigue, dizziness and headache were not resolved and the outcome of the rash and fever were resolved and the outcome of the diarrhea and joint pain were resolving.   It was unknown if the reporter considered the axillary lump, rash, fatigue, dizziness, diarrhea, fever, joint pain and headache to be related to Shingrix.     It was unknown if the company considered the axillary lump, rash, fatigue, dizziness, diarrhea, fever, joint pain and headache to be related to Shingrix.   Additional Information: GSK Receipt date: 22-AUG-2023 A nurse practitioner reported that her patient received a Shingrix vaccination and the next day he began experiencing a headache, bone/joint pain, fever, diarrhea, a rash on his left arm near the site of the vaccination and moving down his arm, dizziness and fatigue.  On 17th August 2023 he noticed a large lump under his axillary area of his left arm measuring 8 cm x 9 cm.  The rash and fever had resolved, and the joint pain had decreased, and the diarrhea had improved, but as of today (reporting day), the other symptoms remain. She had drawn CBC and CMP today and plans an Ultrasound to the lump.  The reporter consented to follow up.
Sex: M
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: pt. will receive 3 doses of T-dap/plans on administering; pt. will receive 3 doses of T-dap/plans on administering; This non-serious case was reported by a other health professional via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 8-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced circumstance or information capable of leading to medication error (Verbatim: pt. will receive 3 doses of T-dap/plans on administering) and inappropriate age at vaccine administration (Verbatim: pt. will receive 3 doses of T-dap/plans on administering).  The outcome of the circumstance or information capable of leading to medication error 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: 22-Aug-2023 The health care professional stated that 8 year old patient never received the D-tap.  According to cdc catch up schedule recommendations, this patient will receive 3 doses of T-dap.  The patient not in the office and has not received the boostrix but reporter plans on administering. No additional information was reported. Did not consent to follow-up. The patient will receive 3 doses of T-dap and has not received the boostrix but reporter plans on administering, which led to circumstance or information capable of leading to medication error and inappropriate age at vaccine administration.
Sex: M
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: She accidently gave a 17 year old male his 3rd dose of Bexsero; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: She accidently gave a 17 year old male his 3rd dose of Bexsero).  The outcome of the extra dose 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: 22-AUG-2023 The healthcare professional was the reporter. The reporter stated she accidently gave a 17 year old male 3rd dose of Bexsero, which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 year old received Boostrix instead of Infanrix; 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 2B723, expiry date 17-OCT-2025) for prophylaxis.   On 22-AUG-2023, the patient received Boostrix. On 22-AUG-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: 4 year old received Boostrix instead of Infanrix).  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: 22-AUG-2023 The reporter stated that a 4 year old received Boostrix instead of Infanrix which led to wrong vaccine administered. The reporter consented to follow up via postal. The vaccine administration facility is the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First Shingrix vaccine about 2 years ago and has not yet received his second Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received by intramuscularly at unknown arm about 2 years ago prior to the reporting).   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: First Shingrix vaccine about 2 years ago and has not yet received his second Shingrix vaccine).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-AUG-2023. The case was reported by patient's wife. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. No other information was known. The reporter did not consent to follow-up. The caller did not give permission to contact HCP. This case had been linked with case US2023114894, as reported by the same reporter.; Sender's Comments:  US-GSK-US2023114894:Same reporter
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Gait disturbance, Injection site pain
Clinical narrative: hard to walk; pain in his right hip/ knee; Injection site tender to touch/ njection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-AUG-2023, the patient received Arexvy (intramuscular). On 20-AUG-2023, less than a day after receiving Arexvy, the patient experienced injection site tenderness (Verbatim: Injection site tender to touch/ njection site pain) and pain in hip (Verbatim: pain in his right hip/ knee ). On 21-AUG-2023, the patient experienced walking difficulty (Verbatim: hard to walk).  The outcome of the injection site tenderness and walking difficulty were not resolved and the outcome of the pain in hip was resolved.   It was unknown if the reporter considered the injection site tenderness, walking difficulty and pain in hip to be related to Arexvy.     It was unknown if the company considered the injection site tenderness, walking difficulty and pain in hip to be related to Arexvy.   Additional Information: GSK Receipt Date: 23-AUG-2023 The reporter reported that the patient received Arexvy vaccine. On same day evening patient experienced injection site pain and pain in his right hip and knee. On Monday 21st August 2023 it was hard for him to walk.   He massaged his leg Monday night, which helped the pain to subside some.   On Tuesday 22nd August 2023 his leg did not work right something was not firing in there.  Patient had an appointment with his healthcare professional tomorrow. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Incomplete course of vaccination
Clinical narrative: Possible late 2nd dose of Shingrix on an unknown date; Circumstance or information capable of leading to medication error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an date received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Possible late 2nd dose of Shingrix on an unknown date) and circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading to medication error).  The outcome of the incomplete course of vaccination and circumstance or information capable of leading to medication error were unknown.   Additional Information: GSK receipt date: 23-Aug-2023 Reported on provider's behalf by sales representative possible late 2nd dose of Shingrix on an unknown date. The vaccine administration facility was the same as primary reporter. No other adverse event information made available Safety team emailed contact information. The patient possible late the 2nd dose, which led to incomplete course of vaccination and circumstance or information capable of leading to medication error. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose to an adult patient; administration of a pediatric Engerix-B vaccine to a 58 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 58-year-old female patient who received HBV (Engerix B pediatric) (batch number CM294, expiry date 19-APR-2024) for prophylaxis.   On 23-AUG-2023, the patient received Engerix B pediatric. On 23-AUG-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose to an adult patient) and adult use of a child product (Verbatim: administration of a pediatric Engerix-B vaccine to a 58 year old patient).  The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt date: 23-AUG-2023 A healthcare professional HCP reported that the administration of a pediatric Engerix-B vaccine to a 58 year old patient which led to underdose and adult use of a child product.  The HCP wanted to know how to proceed with this patient.  The reporter consented to follow up.