chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Caller states the patient reported redness,swelling, severe arm pain, warm to the touch and itchiness at injection site; Caller states the patient reported redness,swelling, severe arm pain, warm to the touch and itchiness at injection site; Caller states the patient reported redness,swelling, severe arm pain, warm to the touch and itchiness at injection site; Caller states the patient reported redness,swelling, severe arm pain, warm to the touch and itchiness at injection site; Caller states the patient reported redness,swelling, severe arm pain, warm to the touch and itchiness at injection site; This spontaneous report was received from a registered nurse and refers to a 44-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 03-DEC-2024 the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # Y011015 and expiration date 18-JUN-2026, 0.5 milliliter, subcutaneously for prophylaxis (site of administration was not provided).  On 03-DEC-2024, the patient experienced reactions after their varicella virus vaccine live (oka/merck) (VARIVAX) administration. Caller stated that the patient reported redness, swelling, severe arm pain, warm to the touch and itchiness at injection site. Caller verified this was the patients first time receiving VARIVAX and has had no prior history of varicella virus. The outcome of vaccination site erythema, vaccination site pruritus, vaccination site warmth, vaccination site pain and vaccination site swelling was reported as not recovered.  The causality between varicella virus vaccine live (oka/merck) (VARIVAX) and reported events was not provided.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Chills, Headache, Pruritus
Clinical narrative: chills; headache; itching and burning is on her stomach, chest, and back; itching and burning is on her stomach, chest, and back; itching and burning is on her stomach, chest, and back; itching and burning is on her stomach, chest, and back; This spontaneous report was received from a Consumer and referred to a 79-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included allergic reaction to antibiotics (unspecified)(captured in US-009507513-2412USA007783). Concomitant therapies were not reported.  On 09-DEC-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, unk, route: injection, administered for prophylaxis (strength, dose, lot #, expiry date were not provided).  Two days later, on 11-DEC-2024, she began experiencing chills, a headache, itching and burning. She reports the itching and burning was on her stomach, chest, and back. She went to a walk-in clinic yesterday (15-DEC-2024) and they gave her a shot of diphenhydramine (BENADRYL). They also told her to take diphenhydramine (BENADRYL) tablets until the symptoms subside. The consumer reports that her symptoms have not improved at this time (not recovered). The action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was also reported as continued.  The causal relationship between the events and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  This is one of the 2 reports regarding the same patient.; Sender's Comments:  US-009507513-2412USA007783:
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Ultrasound antenatal screen, Wrong product administered
Clinical narrative: No additional AE/PQC reported; Consumer called to report an AE for her daughter who was administered the GARDASIL 9 vaccine today while at her OBGYN. Consumer advised her daughter is currently 28 weeks and 3 days pregnant and she is in her third trimester and she was suppose to re; Vaccine exposure during pregnancy; This spontaneous, prospective pregnancy report was received from a consumer refers to a 28-year-old female patient.  The patient's medical history included pregnancy and delivery. The patient has a history of 1 previous pregnancy and 1 live birth. The patient's concomitant therapies included ondansetron (ZOFRAN [ONDANSETRON]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), famotidine (PEPCID [FAMOTIDINE]) and minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) (reported as: prenatal vitimans).  On 16-DEC-2024, the patient was vaccinated in error with shot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection (lot #, expiration date, exact dose, route of administration, anatomical location, and indication (not application) were not provided) instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (wrong product administered).  The patient became pregnant with LMP of unknown exact date in June 2024 (estimated date) and EDD of 06-MAR-2025 (estimated date). On an unknown date, ultrasound was performer but the result was not provided.The pregnancy outcome was pending (exposure during pregnancy). No additional adverse event reported (no adverse event).
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; HCP called to report TE on PROQUAD. HCP stated that the PROQUAD was stored in the refrigerator and administered to multiple patients. Original AE 02722046 filed on 12/13/2024. At the time of the original report (12/13/2024), patient information was n; This spontaneous report was received from medical assistant and refers to a 4-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-OCT-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #Y002099, expiration date: 09-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; inadvertent administration of an expired dose of PNEUMOVAX 23 to a patient on 12/19/2024; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 19-DEC-2024, the patient was inadvertent vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #X018278, expiration date: 24-NOV-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No symptoms reported and no additional details provided.
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: meant booster of ACWY, but MenB (Bexsero) was given instead; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of wrong vaccine administered in a adult patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) for prophylaxis.   On 22-NOV-2024, the patient received Bexsero. On an unknown date, the patient received Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On 22-NOV-2024, an unknown time after receiving Bexsero and not applicable after receiving Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, the patient experienced wrong vaccine administered (Verbatim: meant booster of ACWY, but MenB (Bexsero) was given instead). 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-NOV-2024 The pharmacist reported that the patient came in to clinic and said they were to receive their booster dose and it meant booster of ACWY, but doctor of medicine (MD) assumed it was Meningococcal B (Bexsero) and was given instead, which led to wrong vaccine administered. The reporter said no harm, planned to come receive booster ACWY at next visit, would have been appropriate to receive Meningococcal B 1st dose anyways.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Injection site induration, Injection site mass, Malaise, Pyrexia
Clinical narrative: hard knot in arm at site of injection; hard knot in arm at site of injection; did not feeling well; fever; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site lump in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   Concurrent medical conditions included endometrial neoplasm malignant. Additional patient notes included no known drug allergies. Concomitant products included lenvatinib mesilate (Lenvima).   On an unknown date, the patient received Shingles vaccine (unknown arm) and COVID-19 vaccine (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site lump (Verbatim: hard knot in arm at site of injection), injection site induration (Verbatim: hard knot in arm at site of injection), feeling unwell (Verbatim: did not feeling well) and fever (Verbatim: fever). The outcome of the injection site lump, injection site induration, feeling unwell and fever were not reported.   It was unknown if the reporter considered the injection site lump, injection site induration, feeling unwell and fever to be related to Shingles vaccine.     It was unknown if the company considered the injection site lump, injection site induration, feeling unwell and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-NOV-2024 In 2024, the patient got a Shingles and Covid vaccine and had a reaction and did not feel well so she missed a dose, had a hard knot in arm at site of injection, and fever. It was not related to Lenvima. It was unknown if the reporter considered the injection site induration, injection site lump, feeling unwell and fever to be related to Covid vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I had the first Singrix shot on 11/12/2019; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included urinary tract infection (June of 2018 she went to the hospital for severe Urinary Tract Infection (UTI) which was going into sepsis. She was "fighting for her life" for 3 weeks. She was put in a convalescent hospital as she could not sit up and had to learn how to walk again.) and herpes zoster oticus (The right side of her face dropped. She was misdiagnosed with Bell's Palsy but the true diagnosis was Ramsay Hunt syndrome (which is herpes zoster oticus shingles outbreak affecting the facial nerve near the ear). She lost her hearing (in one ear) and needs to use a walker to walk.). Previously administered products included Shingrix (Patient had the first Shingrix shot on 11/12/2019). Concurrent medical conditions included diverticulitis (Diverticulitis (requiring hospitalization)) and hearing loss (She lost her hearing (in one ear) and needs to use a walker to walk.). Concomitant products included gabapentin.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I had the first Singrix shot on 11/12/2019). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-NOV-2024, 22-NOV-2024 Patient reported that she had the first Shingrix shot on 11-DEC-2019, and did not get the booster. Patient asked was it recommended to get the Booster? Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Product preparation error
Clinical narrative: Shingrix was reconstituted with Boostrix; Shingrix was reconstituted with Boostrix and was given to a male patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Shingrix and Boostrix. On an unknown date, an unknown time after receiving Shingrix and Boostrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix was reconstituted with Boostrix) and inappropriate dose of vaccine administered (Verbatim: Shingrix was reconstituted with Boostrix and was given to a male patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of 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: 21-NOV-2024 Pharmacist called to report that Shingrix was reconstituted with Boostrix and was given to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter wanted to know to were there any safety recommendations and what were the next steps to follow or was there a waiting period to revaccinate the patient. This was 1 of the 4 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024098558:same reporter US-GSK-US2024007061:same reporter US-GSK-US2024054838:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: third dose of Shingrix was given to a patient inadvertently; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 354M3, expiry date 13-NOV-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On 20-NOV-2024, the patient received the 3rd dose of Shingrix. On 20-NOV-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: third dose of Shingrix was given to a patient inadvertently). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 22-NOV-2024 The reporter reported that the third dose of Shingrix was given to a patient inadvertently which led to, extra dose administered. During the same call hcp (Healthcare professional) reported same AE (Adverse event) for two different patients with same initials and stated they were married. The vaccine administration facility was the same as primary reporter. This case had been linked with US2024146636, reported by the same reporter.; Sender's Comments:  US-GSK-US2024146636:another patient
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: doses of Kinrix were expired and administered to patients; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   On 13-NOV-2024, the patient received Kinrix. On 13-NOV-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: doses of Kinrix were expired and administered to patients). 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: 26-NOV-2024 The reporter reported that Kinrix was expired and administered to patient, which led to expired vaccine used. The reporter consented to follow up. This was 1 of 2 linked cases , reported by the same reporter.; Sender's Comments:  US-GSK-US2024148230:Same Reporter US-GSK-US2024148230:Same Reporter
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Kinrix were expired and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   On 15-NOV-2024, the patient received Kinrix. On 15-NOV-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Kinrix were expired and administered to patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-NOV-2024 The reporter reported that Kinrix was expired and administered to patient, which led to expired vaccine used. The reporter consented to follow up. This was 1 of 2 linked cases , reported by the same reporter.; Sender's Comments:  US-GSK-US2024148229:Same Reporter US-GSK-US2024148229:Same Reporter
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the 1st dose of Engerix-B back in 30/May/2024 and hadn't received the 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 58-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 30th May 2024, batch number:YY37B and expiry date: 24th August 2026).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: patient received the 1st dose of Engerix-B back in 30/May/2024 and hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-NOV-2024 The reporter called to inform that a patient received the 1st dose of Engerix-B back and hadn't received the 2nd dose yet. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. Till the time of reporting, the patient did not receive the 2nd dose of Engerix B , which led to incomplete course of vaccination. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021115948:same reporter US-GSK-US2024046319:same reporter
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix + before recommended age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 333SK, expiry date 28-SEP-2025) for prophylaxis.   On 04-NOV-2024, the patient received Boostrix. On 04-NOV-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix + before recommended age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 27-NOV-2024 Medical assistant called to report that Boostrix was administered to a 5-year-old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up via email. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B pediatric dose given to adult patient; Engerix-B pediatric dose given to adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 34-year-old female patient who received HBV (Engerix B pediatric) (batch number 233FT, expiry date 12-DEC-2025) for prophylaxis.   On 27-NOV-2024, the patient received Engerix B pediatric. On 27-NOV-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Engerix-B pediatric dose given to adult patient) and adult use of a child product (Verbatim: Engerix-B pediatric dose given to adult patient). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt date: 27-NOV-2024 The reporter called to report a pediatric dose of Engerix-B was administered to an adult patient at the time of reporting, which led to underdose and adult use of a child product. The reporter consented to follow up via email. The Vaccine Administration Facility is the same as Primary Reporter. This was 1 of 2 linked cases , reported by the same reporter.; Sender's Comments:  US-GSK-US2024107936:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had the first shingrix vaccine over 1 year ago, wondering if they need to start over again or okay to just complete the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over 1 year 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: had the first shingrix vaccine over 1 year ago, wondering if they need to start over again or okay to just complete the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2024 The reporter had a couple patients that had the first shingrix vaccine over 1 year ago, wondering if they need to start over again or okay to just complete the series and what was the efficacy after just 1 dose of the vaccine. The reporter refused any patients demographics or Safety team follow-up. Till the time of reporting, the patients did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second Late Dose; 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 long in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29-AUG-2020).   On 01-DEC-2024, the patient received the 2nd dose of Shingrix. On 01-DEC-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Second Late Dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 02-DEC-2024 The staff member from Doctor's office called to report the following. The patient received 2nd dose three years later so asked was she covered. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix - Inappropriate age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number KY27J, expiry date 11-SEP-2026) for prophylaxis.   On 27-SEP-2024, the patient received Boostrix. On 27-SEP-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix - Inappropriate age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-DEC-2024 A pharmacist called to report the administration of Boostrix to 3 different patients younger than 10 years of age, which led to inappropriate age at vaccine administration. The reporter asked for recommendations on this situation. The reporter consented to follow up. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024151448:same reporter US-GSK-US2024151452:same reporter
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix - Inappropriate age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KY27J, expiry date 11-SEP-2026) for prophylaxis.   On 27-SEP-2024, the patient received Boostrix. On 27-SEP-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix - Inappropriate age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-DEC-2024 A pharmacist called to report the administration of Boostrix to 3 different patients younger than 10 years of age, which led to inappropriate age at vaccine administration. The reporter asked for recommendations on this situation. The reporter consented to follow up. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024151450:same reporter US-GSK-US2024151452:same reporter
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix - Inappropriate age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number KY27J, expiry date 11-SEP-2026) for prophylaxis.   On 27-SEP-2024, the patient received Boostrix. On 27-SEP-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix - Inappropriate age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-DEC-2024 A pharmacist called to report the administration of Boostrix to 3 different patients younger than 10 years of age, which led to inappropriate age at vaccine administration. The reporter asked for recommendations on this situation. The reporter consented to follow up. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR151625:same patient different reporter US-GSK-US2024151448:same reporter US-GSK-US2024151450:same reporter
Age: 74.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received third dose of Twinrix too soon; received third dose of Twinrix too soon; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old male patient who received HAB (Twinrix) (batch number 327E3, expiry date 14-MAY-2025) for prophylaxis.   Co-suspect products included HAB (Twinrix) (batch number H3SG9, expiry date 03-JAN-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 27th February 2023, batch number:2KE55 and expiry date:22-SEP-2023).   On 04-AUG-2023, the patient received the 3rd dose of Twinrix. On 04-MAY-2023, the patient received Twinrix. On 04-MAY-2023, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received third dose of Twinrix too soon). On 04-AUG-2023, the patient experienced drug dose administration interval too short (Verbatim: received third dose of Twinrix too soon). The outcome of the drug dose administration interval too long and drug dose administration interval too short 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: 03-DEC-2024 Pharmacist reported that adult patient received third dose of Twinrix too soon.  The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received 3rd dose of Twinrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Single component of a two-component product administered
Clinical narrative: A patient administered only the adjuvant portion of Shingrix, without mixing with the powder; A patient administered only the adjuvant portion of Shingrix, without mixing with the powder; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: A patient administered only the adjuvant portion of Shingrix, without mixing with the powder) and inappropriate dose of vaccine administered (Verbatim: A patient administered only the adjuvant portion of Shingrix, without mixing with the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-DEC-2024 A Pharmacy district leader called to report that one of their pharmacist accidentally administered only the adjuvant portion of Shingrix, without mixing with the powder, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter wanted to know if it was ok to the patient to come back to receive another dose properly. The reporter did not have any additional patient information. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: gave a pediatric dose to an adult; gave a pediatric dose to an adult; This non-serious case was reported by a nurse 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 YY37B, expiry date 24-AUG-2026) for prophylaxis.   On 20-NOV-2024, the patient received the 2nd dose of Engerix B pediatric. On 20-NOV-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: gave a pediatric dose to an adult) and adult use of a child product (Verbatim: gave a pediatric dose to an adult). The outcome of the underdose and adult use of a child product 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: 03-DEC-2024 The reporter called to inform the following that he/she gave a pediatric dose to an adult, and he/she just realized that it was a month ago, which led to underdose and adult use of a child product. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 14th September 2024, batch number:Y5XPT and expiry date:30th September 2026).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-DEC-2024 The reporter reported that patient received first dose of Engerix-B series on 14Sep2024.  The second dose should have been 1 month after the first dose but had not yet been administered.  The second dose was planned to be given the day after reporting on 5th December 2024. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Till the time of reporting, the patient did not receive the 2nd dose of Engerix B , which led to incomplete course of vaccination.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: vaccine with expiration date of 12-1-24 was administered today 12-4-24; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received MMR (Priorix) (batch number LG722, expiry date 01-DEC-2024) for prophylaxis.   On 04-DEC-2024, the patient received Priorix. On 04-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: vaccine with expiration date of 12-1-24 was administered today 12-4-24). 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: 04-DEC-2024 The reporter called to report a Priorix vaccine with expiration date of 12th November 2024 was administered at the time of reporting, which led to expired vaccine used. The age of the patient asked and declined. The reporter consented to follow up via email agreed.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: a colleague administered yesterday an expired dose of PRIORIX to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received MMR (Priorix) (batch number 7T3HD, expiry date 01-DEC-2024) for prophylaxis.   On 03-DEC-2024, the patient received Priorix. On 03-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: a colleague administered yesterday an expired dose of PRIORIX to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-DEC-2024 The reporter called reporting a colleague administered the day before reporting an expired dose of Priorix to a patient, which led to expired vaccine used. The registered nurse wanted to receive guidance in this topic.  The vaccine detail and vaccination date are retrieved in this call (information detailed in corresponding section above).  No patient demographics was provided from the Registered Nurse´s end during this call.  No further information was obtained during this call. The reporter consented to follow up.
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: MA reports that today a pregnant patient received Arexvy; MA reports that today a pregnant patient received Arexvy; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of drug use in unapproved population in a 37-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3S729, expiry date 06-AUG-2026) for prophylaxis.   On 17-DEC-2024, the patient received Arexvy. On 17-DEC-2024, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved population (Verbatim: MA reports that today a pregnant patient received Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: MA reports that today a pregnant patient received Arexvy). The outcome of the drug use in unapproved population and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 35 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Estimated Delivery/Due date: 15-JAN-2025 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 17-DEC-2024 The reporter reported that pregnant patient received Arexvy at the time of reporting, which led to Drug use in unapproved population and vaccine exposure during pregnancy.   She was 35 weeks and 6 days pregnant. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Musculoskeletal chest pain, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: PARAESTHESIA; TREMOR; CHILLS; MUSCULOSKELETAL CHEST PAIN; MYALGIA; PAIN IN EXTREMITY; Initial information received on 11-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 71 years old female patient who had paraesthesia, tremor, chills, musculoskeletal chest pain, myalgia and pain in extremity after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] And Covid-19 Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity. Notes: Medications At Time Of Vaccination-hydrochlorothiazide, Losartan, Singular, amlodipine, Evista (generic) , fiber drink, Breo Ellipta, none,penicillin, Bactrim/Septra,Calcium, Vit D, cetirizine, aspirin 81 mgs. History/ Allergies- none,penicillin, Bactrim/Septra,Calcium, Vit D, cetirizine, aspirin 81 mgs Ibuprofen  On 04-Oct-2024, the patient received a dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (lot U8527CA) via intramuscular route in the right arm for Prophylactic vaccination and  Covid-19 Vaccine not produced by Sanofi Pasteur (lot 3042388) via intramuscular route in the right arm for COVID-19 immunization (unknown strength, dosage, formulation and expiry date).  On 08-Oct-2024 the patient developed paraesthesia, tremor, chills, musculoskeletal chest pain, myalgia and pain in extremity (latency-4 days) following the administration of Influenza Quadrival A-B High Dose Hv Vaccine and  Covid-19 Vaccine.  Reportedly, four days after injection of both COVID and FLU HD patient had chills, shaking later pain left arm, left trapezious muscle, left chest wall, continued increasing pain with tingling of left 4th an 5th fingers forearm pain. continues with increasing level of pain in that area to filing todays date 05-Nov-2024.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Tremor
Clinical narrative: PARAESTHESIA; TREMOR; CHILLS; MUSCULOSKELETAL CHEST PAIN; MYALGIA; PAIN IN EXTREMITY; Initial information received on 11-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 71 years old female patient who had paraesthesia, tremor, chills, musculoskeletal chest pain, myalgia and pain in extremity after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] And Covid-19 Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity. Notes: Medications At Time Of Vaccination-hydrochlorothiazide, Losartan, Singular, amlodipine, Evista (generic) , fiber drink, Breo Ellipta, none,penicillin, Bactrim/Septra,Calcium, Vit D, cetirizine, aspirin 81 mgs. History/ Allergies- none,penicillin, Bactrim/Septra,Calcium, Vit D, cetirizine, aspirin 81 mgs Ibuprofen  On 04-Oct-2024, the patient received a dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (lot U8527CA) via intramuscular route in the right arm for Prophylactic vaccination and  Covid-19 Vaccine not produced by Sanofi Pasteur (lot 3042388) via intramuscular route in the right arm for COVID-19 immunization (unknown strength, dosage, formulation and expiry date).  On 08-Oct-2024 the patient developed paraesthesia, tremor, chills, musculoskeletal chest pain, myalgia and pain in extremity (latency-4 days) following the administration of Influenza Quadrival A-B High Dose Hv Vaccine and  Covid-19 Vaccine.  Reportedly, four days after injection of both COVID and FLU HD patient had chills, shaking later pain left arm, left trapezious muscle, left chest wall, continued increasing pain with tingling of left 4th an 5th fingers forearm pain. continues with increasing level of pain in that area to filing todays date 05-Nov-2024.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: inappropriate use because PENTACEL was given subcutaneously to a patient (with no reported adverse event); Initial information received on 12-Dec-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves, a 4 years old male patient who had inappropriate use as Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] was given subcutaneously to a patient (with no reported adverse event).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medication includes MMRV, Hep A, & PCV 20.   On 12-Dec-2024, the patient had inappropriate use as 0.5 ml (Standard strength) (once) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (lot UK024AA, expiry date: 30-Apr-2025) was given via subcutaneous route in the left arm for immunization (with no reported adverse event) (Incorrect route of product administration) (latency- same day).  Reportedly, Nurse called with a question in regard to efficacy, she asked if which route of administration is more effective for Pentacel, subcutaneous or intramuscular. She also stated that a patient was given Pentacel subcutaneously.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired ACTHIB (with no reported adverse event); Initial information received on 13-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 months old male patient who was administered with an expired haemophilus type B (HIB) vaccine (ACT-HIB) with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20); varicella zoster vaccine (Varicella vaccine); measles vaccine, mumps vaccine, rubella vaccine (MMR); and hepatitis A vaccine (Hepatitis A vaccine) all for Immunisation.  On 12-Dec-2024, the patient received 0.5 ml of an expired HIB (PRP/T) vaccine Powder and solvent for solution for injection with standard strength (expiry date- 08-NOV-2024 and lot UJ965AA) once via intramuscular route in the right thigh as Immunization with no reported adverse event (expired product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Mobility decreased, Musculoskeletal disorder, Skin tightness, Swelling
Clinical narrative: headaches within 24 hours followed by visible swelling in the hands, elbows, knees, and feet. The hands feel tight and hard to move or use.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electrocardiogram, Joint noise, Limb injury, Magnetic resonance imaging
Clinical narrative: THREW MY "SHOULDER OUT" ON THE PALLET (REDACTED) AND I TOLD TWO OF MY MANAGERS AT WORK. A YEAR LATER MY ARM MADE A LOUD SNAP NOISE WHILE DIGGING OUT FOOTERS IN THE DIRT. BEEN TO THE ER SIX TIMES SINCE, GOTTEN HEALTH INSURANCE FOR MYSELF AND HARDLY RECEIVED ANY CARE JUST A POSSIBLE PERIOCARDITIS WHICH IS NOT WHAT I ASKED FOR I NEED MY SHOULDER FIXED I WAS TOO LATE FOR INSURANCE TO WANT TO COVER IT BUT I KNOW THEY KNOW. I HAVE SPENT CLOSE TO 1000 OUT OF POCKET ON OTC MEDICINE AND GETTING STUFF FROM MY FAMILY 2 YEARS NOW
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: THREW MY "SHOULDER OUT" ON THE PALLET (REDACTED) AND I TOLD TWO OF MY MANAGERS AT WORK. A YEAR LATER MY ARM MADE A LOUD SNAP NOISE WHILE DIGGING OUT FOOTERS IN THE DIRT. BEEN TO THE ER SIX TIMES SINCE, GOTTEN HEALTH INSURANCE FOR MYSELF AND HARDLY RECEIVED ANY CARE JUST A POSSIBLE PERIOCARDITIS WHICH IS NOT WHAT I ASKED FOR I NEED MY SHOULDER FIXED I WAS TOO LATE FOR INSURANCE TO WANT TO COVER IT BUT I KNOW THEY KNOW. I HAVE SPENT CLOSE TO 1000 OUT OF POCKET ON OTC MEDICINE AND GETTING STUFF FROM MY FAMILY 2 YEARS NOW