chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Urinary occult blood positive, Urine abnormality, Urine analysis abnormal, White blood cells urine positive
Clinical narrative: Had vaccine about 10:15 am,about an hour after I developed a headache,arm began to get sore,nothing unusual then.As the night progressed,headache became worse and had chills,slight nausea.Couldn't sleep had to urinate a couple of times during the early am hours,took temp in the am early was 100 at that point. By 5 am felt like I had a severe UTI,frequency,urgency,urethral spasm after voiding.Then by 6am,had hematuria. I emailed my PCP at 7:30 am,I dropped off a urine sample locally.My doctor called in nitrofurintonin prescription for 5 days,100mg   2x per day. Still had headache chills off and on and my arm was very sore. Drank a lot of fluids,took tylenol 650mg,Still had nausea.   By later that day hematuria wasn't visible  anymore to me. Two mornings later,my PCP emailed me with a copy of my urinalysis report,also saying that there was zero bacterial growth.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Injection site erythema, Injection site pruritus
Clinical narrative: Red, itchy and injection site and spreading. Difficulty breathing.
Age: 32.0
Sex: F
Vaccine: FLUC4, PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced redness and swelling around both injection sites. Date of service and reactivity began both on 9/11/23.  She went to clinic down the street and was prescribed Bactrim for presumed cellulitis.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP calling regarding an expired dose of MMRII being given to patient inadvertently. MMRII did not have any previous temperature excursions. No additional AE/PQC.; This spontaneous report was received from a registered nurse and refers to an 1-year-old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On 14-AUG-2023, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose: 0.5 ml, albumin status: recombinant Human albumin (rHA), lot # U025200, expiration date: 13-AUG-2023). Diluent with lot# W011291 and expiration date: 20-NOV-2024 was used. No additional adverse event (AE) was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anticholinergic syndrome, Bradycardia, COVID-19, Mental status changes
Clinical narrative: Patient with history of COVID-19 vaccination admitted to hospital with COVID-19 detected test. Per provider discharge note, "Hospital Course: Patient was admitted for toxic metabolic encephalopathy suspected secondary to polypharmacy and acute hypoxic respiratory insufficiency secondary to COVID Infection. He also presented with bradycardia, for which beta blocker was placed on hold. He complained of urinary retention, likely secondary to anticholinergic syndrome, possibly secondary to patient's home atarax. Patient was weaned off oxygen. His mental status returned to baseline. He was medically optimized and stable for discharge home with appropriate follow up. "
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Toxic encephalopathy, Urinary retention
Clinical narrative: Patient with history of COVID-19 vaccination admitted to hospital with COVID-19 detected test. Per provider discharge note, "Hospital Course: Patient was admitted for toxic metabolic encephalopathy suspected secondary to polypharmacy and acute hypoxic respiratory insufficiency secondary to COVID Infection. He also presented with bradycardia, for which beta blocker was placed on hold. He complained of urinary retention, likely secondary to anticholinergic syndrome, possibly secondary to patient's home atarax. Patient was weaned off oxygen. His mental status returned to baseline. He was medically optimized and stable for discharge home with appropriate follow up. "
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Upon receiving the vaccine, the patient was lightheaded and when sitting in the chair started to feel numb & "like insides were shaking". Patient reported only having eaten cereal & jello all day and had taken hydralazine & carvedilol about an hour before coming for immunization. EMS was contacted and upon evaluation patient was transported to local hospital.
Age: 30.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Allergy to vaccine, Chest pain, Hypersensitivity, Nausea, Throat tightness
Clinical narrative: 30 minutes after receiving both vaccines, the patient reported chest burning and nuasea. Shortly after she reported chest pain and throat closing. She went to the urgent care in the same building as the clinic and received treatment. She states she was told she had an allergic reaction to the vaccines and to take aspirin 325 three times daily by the physician as her discharge instructions.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Oropharyngeal discomfort
Clinical narrative: 10 mins after vaccine given patient complained of "thick throat" difficulty swallowing. No other symptoms noted
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: Patient was administered the Modern Bivalent Booster the same day as the current formulation was pulled to make room for the newest COVID vaccines.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Vaccinated on 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005; Vaccinated on 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005; Vaccinated on 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005; This spontaneous report has been received from a lawyer and physician, via a fact sheet and an immunization record from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2303USA000650), concerning a 4-month-old female patient (pt). The pt's pertinent medical history or concurrent conditions were not reported.   On 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005, the pt was vaccinated with haemophilus b vaccine (manufacturer unknown) (exact dose, anatomical location, route of administration, lot # and expiration date were not reported) for prophylaxis. These was considered to be following events: an inappropriate schedule of vaccine administered, inappropriate age at vaccine administration and an extra dose administered.   The pt's vaccines also included:hepatitis B vaccine (manufacturer unknown) (administered on: 21-SEP-2004, 29-NOV-2004, 21-JAN-2005 and 22-SEP-2010), unspecified diphtheria (+) tetanus (+) pertussis (DTaP) vaccine (administered on: 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005, 24-SEP-2009), unspecified inactivated Poliovirus vaccine (IPV) (administered on 29-NOV-2004, 21-JAN-2005, 27-DEC-2005, 24-SEP-2009), unspecified pneumococcal conjugate-7 vaccine (PCV7) (administered on: 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 22-SEP-2005), measles (+) mumps (+) rubella (MMR) vaccine (manufacturer unknown)(administered on: 22-SEP-2005, 24-SEP-2009), varicella vaccine (manufacturer unknown) (administered on: (22-SEP-2005, 24-SEP-2009), hepatitis A vaccine (manufacturer unknown) (administered on:22-MAR-2006, 26-SEP-2006), unspecified meningococcal conjugate vaccine (MCV4), unspecified influenza vaccine (administered on: 03-OCT-2012, 16-OCT-2013, 01-OCT-2014, 01-OCT-2015, 03-OCT-2016), unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid vaccine (TDAP) (administered on 01-OCT-2015), HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (administered on 03-OCT-2016), unspecified hpv vaccine (manufacturer unknown) (administered on 03-OCT-2017).   This is one of the three reports concerning the same patient.; Sender's Comments:  US-009507513-2309USA001193: US-009507513-2303USA000650:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Needle issue
Clinical narrative: I inserted the syringe/needle combo into the patients arm and when I tried to depress the plunger it would not move and I couldn't administer the solution in the syringe. I had to remove the needle from her arm and remove the defective needle and replace it with a new one. I had to insert the needle a second time to administer the vaccine.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: No related effects noted.; 1 of 3 patients that received dose of VARIVAX after short dated from previous excursion. Initial temperature excursion (TE) completed on line -47 to 77 Fahrenheit degrees (F) for 1 Hour 22 Minute; This spontaneous report was received from a Non-Medical Healthcare Worker, referring to a 4-year-old patient of unspecified gender.   The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 11-AUG-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (involved lot # was W031815, expiration date established and confirmed as 05-OCT-2024 upon internal validation, but also an additional expiration date was reported as 19-JUL-2023 [conflicting information for an expired dose administered with the involved lot #]); given as prophylaxis (strength, route, and site of administration were not provided). Initial temperature excursion (TE) completed on line -47 to 77 Fahrenheit degrees (F) for 1 Hour 22 Minutes. There was no report of side effects, nor product quality complaint was involved.   This is one of three reports from the same reporter.; Sender's Comments:  US-009507513-2309USA003050: US-009507513-2309USA002813: US-009507513-2309USA002813:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash, Rash erythematous, Skin lesion, Vasculitis
Clinical narrative: Developed pink / red cutaneous Rash that grew in size to large 3? x 5? lesions. Several spots all over both legs and one in right arm.  First diagnosed as vasculitis Dermatologist says it may be psoriasis now. Pathology pending.  Been prescribed Clobetasol and Opzelura topical.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant called to report T/E and reported one vaccine had been administered of PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 08-SEP-2023, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live rHA(PROQUAD) injection (lot #W036939, expiration date 19-MAY-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On unknown dates, the measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live rHA(PROQUAD) suffered from a temperature excursion of 6 degrees Fahrenheit (F) up to 14 F for 12 hours 20 minutes and 14 F up to 46 F for 13 hours 45 minutes and 47 F to 77 F for 4 hours. No previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) (No adverse event).
Age: 37.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; HCP called to report PROQUAD had been administered to a 37-year-old female. Patient hasn't reported signs/symptoms of adverse effects. Permission to contact HCP was given. No additional AE/no PQC.; This spontaneous report was received from a pharmacist refers to a 37-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-SEP-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event reported (no adverse event).
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; Pharmacist reported that an adult patient received MMR II on 8/27/2023, and then two weeks later received VARIVAX on 9/10/2023. Whenever patient filled out vaccine paperwork, she selected no that she has not received any vaccines lately. However, aft; This spontaneous report has been received form a pharmacist, regarding a female patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 27-AUG-2023, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported).  Then two weeks after, on 10-SEP-2023, she was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, as prophylaxis as well (lot number: W011622, which was determined to be valid, with an expiration date on 06-APR-2024) (strength, dose, scheme, route and anatomical location of administration were not reported) (Inappropriate schedule of product administration).  It was reported that whenever patient filled out vaccine paperwork, she selected that she did not received any vaccines lately. However, the pharmacist was reviewing records and noticed patient received the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) two weeks before.   Pharmacist also asked if varicella virus vaccine live (Oka/Merck) (VARIVAX) could be administered both intramuscular and subcutaneous route.  No additional adverse event was reported.   This is one of two cases from the same reporter.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Confirmed no side effects or symptoms reported.; Nurse called to report that a first dose of ROTATEQ was administered to a 7 month old, however calculated age of patient is 5 months old as he was born prematurely at 30 weeks gestation. Nurse reports they do not deliver live viruses in their NICU an; This spontaneous report was received from a registered nurse and refers to a 7-month-old male patient. The patient's medical history included neonatal intensive care unit (NICU) visit. The patient's concurrent conditions included being born prematurely. Concomitant therapies were not reported.  On 07-SEP-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml/one of three doses, lot #1918233, expiration date: 19-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). It was reported that the patient was 7 month old at the time of vaccination (product administered to patient of inappropriate age), however calculated age of this patient was 5 months old as he was born prematurely at 30 weeks gestation. Also, the nurse reported that they did not deliver live viruses in their NICU and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was a live virus which was why he hasn't received his initial dose while in the NICU. It was confirmed that no side effects or symptoms were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; Caller reported AE on behalf of a patient who was administered PROQUAD that was improperly stored. No symptoms reported. Obtained consent to contact HCP. TE Filed (Case #02470622). Additional AE Filed (Case #02470636). No additional AE/PQC.  Product:; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 21-AUG-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5, milliliter, lot #X009730, expiration date: 30-SEP-2024, (strength, dose#, route of vaccination, and anatomical site of vaccination were not provided),for prophylaxis (product storage error).The suspect vaccine underwent a temperature excursion between 6 to 14 Fahrenheit degrees for 1 hour 10 minutes. The previous temperature excursions was reported as: none. No additional adverse event (AE) was reported (no adverse event).
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; HCP calling to report an expired MMRII was administered after it expired. Vaccine expired on 8/4/2023. HCP reports the vaccine has not experienced any temperature excursions.  No additional AE/PQC.; This spontaneous report as received from a medical assistant refers to a 1-year-old male patient.  The patient's medical history and concurrent conditions were not provided. The patient's concomitant therapies included STRILE DILUENT.   On 12-SEP-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) lot #U024229, expiration date: 04-AUG-2023, 0 .5 milliliter (route of administration and anatomical location were not provided) for prophylaxis (expired product administered). It was reported that the vaccine had not experienced any temperature excursions. No additional adverse event reported (no adverse event).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Illness, Pain, Pain in extremity
Clinical narrative: Then I had singles under my breast/Suspected Vaccination failure; Then I had singles under my breast/Since then I've been having mini patches of shingles each time different spot Chest, elbow, thigh.; The second dose I got so sick; was in pain for 2 days/Painful; Swollen arm; Arm that was red; Pain in arm; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Then I had singles under my breast/Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Then I had singles under my breast/Since then I've been having mini patches of shingles each time different spot Chest, elbow, thigh.), sickness (Verbatim: The second dose I got so sick), pain (Verbatim: was in pain for 2 days/Painful), swelling arm (Verbatim: Swollen arm), erythema of extremities (Verbatim: Arm that was red) and pain in arm (Verbatim: Pain in arm).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the sickness, pain, swelling arm, erythema of extremities and pain in arm were resolved (duration 2 days).   The reporter considered the vaccination failure, shingles, sickness, pain, swelling arm, erythema of extremities and pain in arm to be possibly related to Shingrix. The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure, shingles, sickness, pain, swelling arm, erythema of extremities and pain in arm to be possibly related to Shingrix. The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: GSK Receipt date: 08-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that she took her vaccine last year.  The second dose she got so sick and was in pain for 2 days with swollen arm very red and painful.  Then she had singles under her breast it stayed for 2 months and Since then she had mini  patches of shingles each time different spot Chest, elbow and thigh.  The patient stated that she learned that even with vaccine you might had shingles, if you're not vaccinated and had shingles, you could start meds in the first 72 hours, you would be fine. The patient would never get any vaccine ever. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Vaccination failure
Clinical narrative: Then I had singles under my breast/Suspected Vaccination failure; Then I had singles under my breast/Since then I've been having mini patches of shingles each time different spot Chest, elbow, thigh.; The second dose I got so sick; was in pain for 2 days/Painful; Swollen arm; Arm that was red; Pain in arm; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Then I had singles under my breast/Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Then I had singles under my breast/Since then I've been having mini patches of shingles each time different spot Chest, elbow, thigh.), sickness (Verbatim: The second dose I got so sick), pain (Verbatim: was in pain for 2 days/Painful), swelling arm (Verbatim: Swollen arm), erythema of extremities (Verbatim: Arm that was red) and pain in arm (Verbatim: Pain in arm).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the sickness, pain, swelling arm, erythema of extremities and pain in arm were resolved (duration 2 days).   The reporter considered the vaccination failure, shingles, sickness, pain, swelling arm, erythema of extremities and pain in arm to be possibly related to Shingrix. The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure, shingles, sickness, pain, swelling arm, erythema of extremities and pain in arm to be possibly related to Shingrix. The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: GSK Receipt date: 08-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that she took her vaccine last year.  The second dose she got so sick and was in pain for 2 days with swollen arm very red and painful.  Then she had singles under her breast it stayed for 2 months and Since then she had mini  patches of shingles each time different spot Chest, elbow and thigh.  The patient stated that she learned that even with vaccine you might had shingles, if you're not vaccinated and had shingles, you could start meds in the first 72 hours, you would be fine. The patient would never get any vaccine ever. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Erythema, Extra dose administered, Oral mucosal blistering, Pain in extremity
Clinical narrative: Extra dose administered; blister around mouth; blister around nose area/ almost blister looking; very itchy; arm still very red; arm still very sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of oral mucosa blister in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-SEP-2023, the patient received the 3rd dose of Shingrix. On 06-SEP-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Extra dose administered). In SEP-2023, the patient experienced oral mucosa blister (Verbatim: blister around mouth), blister (Verbatim: blister around nose area/ almost blister looking), pruritus (Verbatim: very itchy), erythema of extremities (Verbatim: arm still very red) and pain in arm (Verbatim: arm still very sore).  The outcome of the oral mucosa blister, blister and pruritus were not reported and the outcome of the erythema of extremities and pain in arm were not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the oral mucosa blister, blister, pruritus, erythema of extremities and pain in arm to be related to Shingrix.     It was unknown if the company considered the oral mucosa blister, blister, pruritus, erythema of extremities and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 08-SEP-2023 This case was reported the patient via (Shingrix GSK) interactive digital media. The patient received the shot and was very itchy, blister looking around mouth and nose. The patient's arm was still (at the time of reporting), was very sore and red. The patient received the 3rd shot which led to extra dose administered. Follow-up not possible as no contact details provided
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Extra dose administered; blister around mouth; blister around nose area/ almost blister looking; very itchy; arm still very red; arm still very sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of oral mucosa blister in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-SEP-2023, the patient received the 3rd dose of Shingrix. On 06-SEP-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Extra dose administered). In SEP-2023, the patient experienced oral mucosa blister (Verbatim: blister around mouth), blister (Verbatim: blister around nose area/ almost blister looking), pruritus (Verbatim: very itchy), erythema of extremities (Verbatim: arm still very red) and pain in arm (Verbatim: arm still very sore).  The outcome of the oral mucosa blister, blister and pruritus were not reported and the outcome of the erythema of extremities and pain in arm were not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the oral mucosa blister, blister, pruritus, erythema of extremities and pain in arm to be related to Shingrix.     It was unknown if the company considered the oral mucosa blister, blister, pruritus, erythema of extremities and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 08-SEP-2023 This case was reported the patient via (Shingrix GSK) interactive digital media. The patient received the shot and was very itchy, blister looking around mouth and nose. The patient's arm was still (at the time of reporting), was very sore and red. The patient received the 3rd shot which led to extra dose administered. Follow-up not possible as no contact details provided
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Adult dose administered in errror; Adult dose administered in errror; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HAV (Havrix 1440 adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 17-AUG-2023, the patient received the 2nd dose of Havrix 1440 adult (intramuscular). On 17-AUG-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: Adult dose administered in errror) and adult product administered to child (Verbatim: Adult dose administered in errror).  The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 6-Sept-2023 The reporter reprtoed that the encounter cashier marked adult dose and nurse herself grabbed the adult dose. EHR unavailable during administration (there was a safety message that would have alerted the patient to check the dose had it been working). The reporter was unable to read the patient's voicemail twice left asking for returned. The patient received an adult of Havrix in error, which led to overdose and adult product administered to child. Summary of changes: Suspect details, event details and narrative were updated.  Upon internal review, the case was updated on 14th September 2023: Summary of changes: The case was changes from invalid report to valid report.
Sex: U
Vaccine: RSV
Symptoms: Intercepted product preparation error
Clinical narrative: accidentally injected the contents of 1 Arexvy adjuvant vial into another Arexvy adjuvant vial; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number HL594, expiry date 19-OCT-2024) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product preparation error (Verbatim: accidentally injected the contents of 1 Arexvy adjuvant vial into another Arexvy adjuvant vial).  The outcome of the intercepted product preparation error was unknown.   Additional Information: GSK receipt date: 6-Sept-2023 The pharmacist called to report that there was no patient involvement with this event. The reporter consented to follow-up with health care professional/ pharmacy was obtained. The pharmacist accidentally injected the contents of 1 Arexvy adjuvant vial into another Arexvy adjuvant vial one day prior to the reporting date, which led to intercepted product preparation error.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: over a month ago she had a shingles rash on left hip, this is the 4th time since getting SHINGRIX; The caller states she received dose 1 of SHINGRIX in 2019. She never had dose 2; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingles prior to getting SHINGRIX vaccine in 2019 (the patient had shingles prior to getting SHINGRIX vaccine in 2019).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: over a month ago she had a shingles rash on left hip, this is the 4th time since getting SHINGRIX) and incomplete course of vaccination (Verbatim: The caller states she received dose 1 of SHINGRIX in 2019. She never had dose 2).  The outcome of the shingles was resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date 6th Sep 2023 The patient received dose 1 of SHINGRIX in 2019. She never had dose 2. She stated a little over a month ago she had a shingles rash on left hip, this was the 4th time since getting SHINGRIX. She mentioned she had shingles (on left hip) prior to getting SHINGRIX in 2019. She would speak to her HCP ( would have an appointment on 7th September 2023) to decide if would get dose 2 of SHINGRIX soon.  Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: pain at the injection site; edema at the injection site; fever; fatigue; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ibuprofen and paracetamol (Tylenol).   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site), injection site edema (Verbatim: edema at the injection site), fever (Verbatim: fever) and fatigue (Verbatim: fatigue).  The outcome of the injection site pain, injection site edema, fever and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, injection site edema, fever and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site edema, fever and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2023 The patient was in her 60's. The patient had a Shingrix vaccine and 8 days later came back to the pharmacy / clinic.  The patient complaint of pain and edema at the injection site.  Patient also complaint of fever and fatigue.   Field Representative did not have information on when the symptoms started or if they were resolved. The reporter consented to follow up via email. No further information available.
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: administration of Shingrix to patient that was stored at 30.308F x 20 hours; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 9277T, expiry date 16-AUG-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: administration of Shingrix to patient that was stored at 30.308F x 20 hours).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 6th September 2023 The pharmacist reported administration of Shingrix to patient that was stored at 30.308F x 20 hours. Unknown date of administration. The permission for safety follow-up was not asked. The shingrix vaccine was stored at 30.308F x 20 hours which led to incorrect storage of drug.
Sex: F
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: administration of Arexvy to patient that was stored at 30.308 Fahrenheit by 20 hours; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3AK2K, expiry date 09-DEC-2024) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: administration of Arexvy to patient that was stored at 30.308 Fahrenheit by 20 hours).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 06-SEP-2023  The pharmacist reported administration of Arexvy vaccine to patient that was stored at 30.308 Fahrenheit by 20 hours which led to incorrect storage of drug. The date of administration was unknown.
Sex: M
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: administration of Arexvy to patient that was stored at 30.308F x 20 hours; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3AK2K, expiry date 09-DEC-2024) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: administration of Arexvy to patient that was stored at 30.308F x 20 hours).The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 06-SEP-2023 The reporter reported that administration of Arexvy to patient that was stored at 30.308F x 20 hours, which led to incorrect storage of drug. The date of administration was unknown. The reporter did not get permission for safety follow-up at time of call.
Sex: M
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: Arexvy to patient that was stored at 30.308F x 20 hours; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 64-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3AK2K, expiry date 09-DEC-2024) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Arexvy to patient that was stored at 30.308F x 20 hours).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 06-SEP-2023 The vaccine was exposed to 30.308 degree Fahrenheit for 20 hours, which led to incorrect storage of drug. The reporter did not consent to follow up.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Maladministration of Priorix prefilled syringe (diluent only) without being mixed; Maladministration of Priorix prefilled syringe (diluent only) without being mixed; 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 MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of Priorix prefilled syringe (diluent only) without being mixed) and inappropriate dose of vaccine administered (Verbatim: Maladministration of Priorix prefilled syringe (diluent only) without being mixed).  The outcome of the inappropriate preparation of medication 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: 6-Sept-2023 Medical information department had just received the veevaCRM.  The reporter asked that if there was any information on Priorix being reconstituted incorrectly and he was concerned that the Priorix prefilled syringe (diluent only) might be given to a patient without being mixed with the accompanying vial of vaccine.  The reporter also asked that did they have any data of the frequency of this happening. The reporter consented to follow-up. The patient received only received diluent of Priorix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: dose of Kinrix that was administered 05Sep2023 from lot number H99J7, which had an expiration date of 26May2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 05-SEP-2023, the patient received Kinrix. On 05-SEP-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: dose of Kinrix that was administered 05Sep2023 from lot number H99J7, which had an expiration date of 26May2023).  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: 6th Sep 2023 Physician Assistant reported he was consulted about a dose of Kinrix that was administered on 05Sep2023 which had an expiration date of 26May2023. At the time of reporting, the reporter did not had any patient information or further details. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received kinrix vaccine which was already expired which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Needle issue, Product complaint, Underdose
Clinical narrative: Administering only about 0.1ml to the patient.; Needle was defective; Product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose 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 underdose (Verbatim: Administering only about 0.1ml to the patient.), needle issue (Verbatim: Needle was defective) and pharmaceutical product complaint (Verbatim: Product complaint).  The outcome of the underdose, needle issue and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 07-SEP-2023 The reporter reported that while administering Shingrix vaccine to the patient the needle was defective and leaked, administering only about 0.1 ml to the patient, which led to underdose and needle issue. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first Shingrix dose was in 2019. She received her second dose in MAR-2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2019).   In MAR-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first Shingrix dose was in 2019. She received her second dose in MAR-2023).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 7-Sept-2023 Nothing else was reported. The reporter did not consent to follow-up. The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 72.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Diarrhoea, Incorrect dose administered, Pain
Clinical narrative: body aches; diarrhea; accidently received 2 doses of AREXVY on Wednesday 6-SEP-2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-SEP-2023, the patient received the 2nd dose of Arexvy and the 1st dose of Arexvy. On 06-SEP-2023, an unknown time after receiving Arexvy and not applicable after receiving Arexvy, the patient experienced accidental overdose (Verbatim: accidently received 2 doses of AREXVY on Wednesday 6-SEP-2023). On 07-SEP-2023, the patient experienced general body pain (Verbatim: body aches) and diarrhea (Verbatim: diarrhea).  The patient was treated with paracetamol (Tylenol). On 07-SEP-2023, the outcome of the diarrhea was resolved.  On 08-SEP-2023, the outcome of the general body pain was resolved (duration 1 day). The outcome of the accidental overdose was unknown.   It was unknown if the reporter considered the general body pain and diarrhea to be related to Arexvy and Arexvy.     It was unknown if the company considered the general body pain and diarrhea to be related to Arexvy and Arexvy.   Additional Information: GSK receipt date: 08-SEP-2023 Reporter was the patient, who accidently received 2 doses of Arexvy on Wednesday.  The patient experienced diarrhea on Thursday morning which resolved midday. She experienced body aches late Thursday for which she took Tylenol and resolved when she woke up today (on the day of reporting). The patient received accidentally received 2 dose Arexvy on same day, which led accidental overdose. The reporter consented to follow up.Call Notes:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: started having hives around the injection site; there is redness and pain at the injection site; Swelling at the injection site; Redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-SEP-2023, the patient received the 1st dose of Shingrix (left arm). On 05-SEP-2023, less than a day after receiving Shingrix, the patient experienced injection site hives (Verbatim: started having hives around the injection site). In SEP-2023, the patient experienced injection site pain (Verbatim: there is redness and pain at the injection site), injection site swelling (Verbatim: Swelling at the injection site) and injection site erythema (Verbatim: Redness at the injection site).  On 08-SEP-2023, the outcome of the injection site hives was resolved (duration 3 days). The outcome of the injection site pain and injection site swelling were unknown and the outcome of the injection site erythema was not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site hives to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, injection site erythema and injection site hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-SEP-2023 The patient self-reported this case. On the vaccination day, the patient started having hives around the injection site, by Wednesday the hives were really bad.  The hives were gone today (on the reporting day) and there was redness and pain at the injection site. The reporter did not consent to follow-up.