chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: VARZOS, PNC20, VARZOS
Symptoms: Chills, Dysstasia, Gait disturbance, Muscle spasms, Orthosis user
Clinical narrative: 1 Day through Day 5 after Shingrix shot - muscle spasms in lower back muscles that lasted 5 days - had to take a muscle relaxant and wear a back brace to help move around (walk, get up, sit, lay down) -Day 2  through Day 4 after shot - Fever and chills -Day 5 through Day 13 (current day)  after shot - outbreak of chickenpox sores in mid torso, ankles, and a few spots on back, legs, and arms.   -Day 10 after shot -  sent doctor pictures of dots asking if a side affect of Shingrix vaccine---he confirmed it looked like Chickenpox but had never heard of such a reaching to a shingles vaccine.  No treatment--advised not to go out around unvaccinated people or anyone pregnant. NOTE:  The spots were red with white tips, look exactly like chicken pox sores, itched a lot at first, and only appeared in large numbers around mid-torso and ankles with just a few random spots anywhere else. -Day 13 after shot - spots not as bright red, but appear to be slowly fading in color, with less and less of them itching--Presume have to let run its course for another week after review with doctor -Patient remaining at home away from crowds
Age: 57.0
Sex: M
Vaccine: VARZOS, PNC20, VARZOS
Symptoms: Pyrexia, Rash macular, Rash pruritic, Skin lesion, Varicella
Clinical narrative: 1 Day through Day 5 after Shingrix shot - muscle spasms in lower back muscles that lasted 5 days - had to take a muscle relaxant and wear a back brace to help move around (walk, get up, sit, lay down) -Day 2  through Day 4 after shot - Fever and chills -Day 5 through Day 13 (current day)  after shot - outbreak of chickenpox sores in mid torso, ankles, and a few spots on back, legs, and arms.   -Day 10 after shot -  sent doctor pictures of dots asking if a side affect of Shingrix vaccine---he confirmed it looked like Chickenpox but had never heard of such a reaching to a shingles vaccine.  No treatment--advised not to go out around unvaccinated people or anyone pregnant. NOTE:  The spots were red with white tips, look exactly like chicken pox sores, itched a lot at first, and only appeared in large numbers around mid-torso and ankles with just a few random spots anywhere else. -Day 13 after shot - spots not as bright red, but appear to be slowly fading in color, with less and less of them itching--Presume have to let run its course for another week after review with doctor -Patient remaining at home away from crowds
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion and administered to patient; This spontaneous report was received from a medical assistant referring to a 12-month-old male patient. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 16-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot# W006412, expiration date upon internal review was established as 23-FEB-2024, dose and strength were not reported) intramuscularly in right thigh for prophylaxis at a private doctor's office/hospital, after a temperature excursion. Total time in the range of -14 degree Celsius to -10 degree Celsius was 1 hour. Total combined excursion time was 1 hour (product storage error). This adverse event was previously reported to manufacturer. No additional adverse events were provided (no adverse event).  This is one of several reports reported by the same reporter.; Sender's Comments:  US-009507513-2304USA007931: US-009507513-2303USA002114:
Sex: F
Vaccine: HEPA
Symptoms: Skin laceration, Syringe issue
Clinical narrative: a prefilled syringe VAQTA's finger flange was broken and a nurse's finger was cut.; a prefilled syringe VAQTA's finger flange was broken and a nurse's finger was cut.; This spontaneous report was received from an office manager regarding a female patient (reported as nurse) of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-MAY-2023, a vaccine of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, lot #X004813, expiration date: 28-JUL-2024 had the finger flange broken (Syringe issue) and a nurse's (the patient) finger was cut (Skin laceration). Product Quality Complaint (PQC) was filed. The syringe was broken into 2 o more pieces, it was stated that it was possible that the syringe was broken while the nurse was administering the vaccine, and the syringe tray was intact and undamaged on receipt. It was not difficult trying to attach the syringe needle to the syringe, the syringe tip cap was attached properly prior to use, the product was administered, and the cellophane cover of the syringe tray was intact and completely sealed. On 12-MAY-2023, it was reported that the product was returned. At the time of reporting, the outcome of skin laceration was not provided.   The causal relationship between skin laceration and hepatitis a vaccine, inactivated (VAQTA) was unknown.  This is one of two cases received from the same reporter. ; Sender's Comments:  US-009507513-2305USA002045:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion for VARIVAX; This spontaneous report was received from a practice manager with responsibility for vaccine storage referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 28-APR-2023, the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot#: W025277, expiration date: 10-AUG-2024; strength, dose, route of administration, and anatomical location were not provided) for prophylaxis. The vaccine administered experienced a temperature excursion before at 22.3 F for 1 hour 9 minutes (product storage error). No additional adverse events (AE) (no adverse event).
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, RV5, DTPPVHBHPB, RV5
Symptoms: Extra dose administered, Product dose omission issue
Clinical narrative: the patient has not experienced any adverse reactions associated with the administrations; the patient was accidently administered another dose of VAXELIS and ROTATEQ.; a patient missed her 4 month well child visit to receive her VAXELIS and ROTATEQ vaccines.; This spontaneous report was received from a medical assistant regarding an 6-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2023, the patient missed her 4 month well child visit to receive her rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS) doses (Product dose omission issue). On 27-APR-2023, she was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, administered orally as prophylaxis (strength, lot #, and expiry date were not provided); and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), product quantity 1, 0.5 milliliter (strength, formulation, lot #, expiry date, route of administration, and indication were not provided) at her 6 month well child check up. On 11-MAY-2023, the patient was accidentally vaccinated with another dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, product quantity 1, 2 milliliter, lot #1932214, expiration date: 11-APR-2024, administered orally as prophylaxis; and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), product quantity 1, 0.5 milliliter, batch/lot #U7296AA, and expiration date: 26-FEB-2025 (strength, formulation, route of administration, and indication were not provided) (Extra dose administered). It was reported that the patient had not experienced any adverse reactions associated with the administrations.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, RV5, DTPPVHBHPB, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: the patient has not experienced any adverse reactions associated with the administrations; the patient was accidently administered another dose of VAXELIS and ROTATEQ.; a patient missed her 4 month well child visit to receive her VAXELIS and ROTATEQ vaccines.; This spontaneous report was received from a medical assistant regarding an 6-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2023, the patient missed her 4 month well child visit to receive her rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS) doses (Product dose omission issue). On 27-APR-2023, she was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, administered orally as prophylaxis (strength, lot #, and expiry date were not provided); and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), product quantity 1, 0.5 milliliter (strength, formulation, lot #, expiry date, route of administration, and indication were not provided) at her 6 month well child check up. On 11-MAY-2023, the patient was accidentally vaccinated with another dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, product quantity 1, 2 milliliter, lot #1932214, expiration date: 11-APR-2024, administered orally as prophylaxis; and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), product quantity 1, 0.5 milliliter, batch/lot #U7296AA, and expiration date: 26-FEB-2025 (strength, formulation, route of administration, and indication were not provided) (Extra dose administered). It was reported that the patient had not experienced any adverse reactions associated with the administrations.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: a fever of 104F; This spontaneous report was received from a physician via company representative and referred to the 5-year-old male patient. The patient's concurrent condition, concomitant therapy, medical history and drug reactions/allergies were unknown.  On an unknown date, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (1 dosage form, lot #, expiration date, route and anatomical location were not provided) for prophylaxis.  On an unknown date, the patient developed a fever of 104 Fahrenheit degree (F) after he received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The customer said the patient's family took him to the emergency room. It was unknown if the treatment was given for event. The patient south medical attention. The outcome of fever was unknown. The causality between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and fever was not reported.
Age: 11.0
Sex: U
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No additional AEs/PQCs reported; all lots of GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This spontaneous report has been received from an office manager regarding an 11-year-old patient of unknown gender. The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions, and concomitant therapies were not reported.  On 09-SEP-2022 and 16-SEP-2022, it was reported that some hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine had suffered a temperature excursion. On 01-JAN-2023, the vaccines suffered another temperature excursion and on 24-MAR-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection (product storage error), administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; however, it was not specified which one was received by the patient), (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). All temperature excursions had a total time of 25 minutes (lasting for 8, 5 and 12 minutes, respectively). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (The temperature excursion occurred as a result of a reading from a Digital Data Logger).  This is one of several reports received from the same reporter.
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This spontaneous report was received from an office manager and refers to a 11-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported  On 13-FEB-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites and routes of administration were not provided) administered for prophylaxis (product storage error and no adverse event).  Temperature excursion total time was 25 minutes. There were 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day. Patient was vaccinated in private doctor's office/hospital.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:MSD
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No issues/No Adverse event on Patient; Temperature Excursion; This spontaneous report was received from an office manager and refers to a 11-year-old male patient. No information on patient medical history, current conditions and concomitant medications was provided.  On 31-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis (product storage error and no adverse event).  Temperature excursion total time was 25 minutes. There were 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Age: 10.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No additional AEs/PQCs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This spontaneous report has been received from an office manager regarding a 10-year-old male patient. The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions, and concomitant therapies were not reported.  On 09-SEP-2022 and 16-SEP-2022, it was reported that some hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine had suffered a temperature excursion. On 01-JAN-2023, the vaccines suffered another temperature excursion and on 20-FEB-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection (product storage error), administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; however, it was not specified which one was received by the patient), (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). All temperature excursions had a total time of 25 minutes (lasting for 8, 5 and 12 minutes, respectively). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (The temperature excursion occurred as a result of a reading from a Digital Data Logger).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Caller reported an AE for PROQUAD. The caller said an expired dose of PROQUAD was administered to a patient on 5/15/2023. Confirmed with caller no other AE occurred. AE letter sent to caller. No other AE. No PQC.; This spontaneous report was received from a nurse refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported  On 15-MAY-2023, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot# u031562, expiration date: 06-APR-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events reported (no adverse event).
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Migraines quit and haven't come back; This non-serious case was reported by a consumer and described the occurrence of unexpected therapeutic effect in a 69-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (In 2004). Concurrent medical conditions included migraine headache (very painful migraine headaches 2-3 times a week) and neck pain.   On 20-JAN-2023, the patient received the 1st dose of Shingles vaccine. On 03-FEB-2023, 14 days after receiving Shingles vaccine, the patient experienced unexpected therapeutic effect (Verbatim: Migraines quit and haven't come back). The outcome of the unexpected therapeutic effect was unknown.   Additional Information: GSK Receipt Date: 26-APR-2023 The reporter stated that after the bout with shingles he started getting very painful migraine headaches 2-3 times a week.  After having the first of two shingles shots, the patient's migraines quit and had not came back.  The reporter just wanted to let us know and thank you for getting rid of that pain in his head and neck.
Sex: U
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: Heart rate was elevated / north of 150 bpm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced heart rate increased (Verbatim: Heart rate was elevated / north of 150 bpm). The outcome of the heart rate increased was not resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingles vaccine.     It was unknown if the company considered the heart rate increased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient experienced heart rate was elevated for 24 hours. The patient stated just standing and it was north of 150 bpm.  The patient stated no thanks to the 2nd dose. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: arm pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of pain in extremity (received 1st dose in October 2019, refer linked case US2023AMR067485).   In DEC-2019, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm pain). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR067485   Additional Information: GSK Receipt Date: 31-Mar-2023 The reporter had the Shingrix vaccine in October 2019 and the 2nd dose in December 2019. The only issue they had was a sore arm. The reporter informed about his/her sister-in-law who had been dealing with the after affects of shingles for 2 and half years. Her shingles went into postherpetic neuralgia. The pain and anguish this woman had gone through was unbelievable.  She had shingles around her eye area and was just fortunate she did not lose her vision. She had been to countless doctors but still had the pain.  The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR067485:same patient 1st dose
Sex: U
Vaccine: DTAP, UNK
Symptoms: Blister, Erythema, Feeling hot, Interchange of vaccine products
Clinical narrative: Previously, she received 2 doses of Daptacel DTAP; Large pancake-size area of redness; Large pancake size area of warmth; Huge fluid filled blisters; This non-serious case was reported by a nurse and described the occurrence of localized erythema in a 3-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL (DTAP VACCINE)) for prophylaxis.   Previously administered products included Daptacel DTAP with an associated reaction of no adverse event.   On 04-MAY-2023, the patient received Infanrix. On an unknown date, the patient received DAPTACEL (DTAP VACCINE). In MAY-2023, 24 hrs after receiving Infanrix, the patient experienced localized erythema (Verbatim: Large pancake-size area of redness), localized feeling of warmth (Verbatim: Large pancake size area of warmth) and blister (Verbatim: Huge fluid filled blisters). On an unknown date, the patient experienced interchange of vaccine products (Verbatim: Previously, she received 2 doses of Daptacel DTAP). The outcome of the localized erythema, localized feeling of warmth and blister were not reported and the outcome of the interchange of vaccine products was unknown.   It was unknown if the reporter considered the localized erythema, localized feeling of warmth and blister to be related to Infanrix and Infanrix Pre-Filled Syringe Device.     It was unknown if the company considered the localized erythema, localized feeling of warmth and blister to be related to Infanrix and Infanrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAY-2023 Previously the patient received two doses of Daptacel DTAP on an unknown date and did not had a reaction. The nurse reported that one of the patients received an Infanrix DTAP vaccine and within 24 hours, she developed a large pancake-size area of redness and warmth followed by huge fluid filled blisters forming around the perimeter of the red area.  The reporter stated that this was an uncommon reaction, and that the reporter was trying to determine if patient had an allergic reaction to an ingredient that would be in Infanrix DTAP but was not present in Daptacel DTAP. The reporter asked had GSK seen this kind of reaction before and did GSK know what ingredient might had caused this reaction. The reporter stated that any help provided would be greatly appreciated. Previously the patient received 2 doses of Daptacel DTAP which led to interchange of vaccine products.
Sex: F
Vaccine: MENB
Symptoms: Intercepted product prescribing error
Clinical narrative: Over age recommendation by Doctor; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a adult female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy. Additional patient notes included the patient had no spleen.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted drug prescribing error (Verbatim: Over age recommendation by Doctor). The outcome of the intercepted drug prescribing error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAY-2023 The patient had no spleen. The product had not been given. The patients demographics were not provided. The reporter granted consent to follow up. The physician sent a patient who was above the age of 25 to get Bexsero dose, which led to intercepted drug prescribing error.
Sex: M
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Boostrix and the syringe leaked administrating less than the recommended volume; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 55-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 34FR4, expiry date 23-SEP-2024) for prophylaxis.  On 10-MAY-2023, the patient received Boostrix. On 10-MAY-2023, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: Boostrix and the syringe leaked administrating less than the recommended volume). The outcome of the incomplete dose administered was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 10-MAY-2023 The reporter had stated that, Boostrix product leaked and does not touched the patient's arm..  The plunger disconnected from the rest of the injection and it leaked directly to the floor. Pharmacist reported on 10 May 2023 that patient received today (at the day of reporting) Boostrix and the syringe had leaked, administrating less than the recommended volume.  The vaccine administration facility was the same as primary reporter. The reporter had denied consent to follow-up. The injection had leaked directly to the floor and the patient had received less than the recommended volume, which had led to Incomplete dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: which caused a general feeling of being unwell; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   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 feeling unwell (Verbatim: which caused a general feeling of being unwell). The outcome of the feeling unwell was resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAY-2023 The reporter was the patient. The patient reported that of having a slight reaction to his second dose of Shingrix, which had caused a general feeling of being unwell. The reporter had denied consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Malaise, Pain in extremity
Clinical narrative: He has been not feeling good; He is in severe pain today/starts in his arm and goes across his chest; He is in severe pain today/starts in his arm and goes across his chest; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a male patient who received Herpes zoster (Shingrix) for prophylaxis.  On 08-MAY-2023, the patient received Shingrix. In MAY-2023, an unknown time after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: He has been not feeling good), pain in arm (Verbatim: He is in severe pain today/starts in his arm and goes across his chest) and chest pain (Verbatim: He is in severe pain today/starts in his arm and goes across his chest). The outcome of the feeling abnormal, pain in arm and chest pain were not resolved.  The reporter considered the feeling abnormal, pain in arm and chest pain to be related to Shingrix.  The company considered the feeling abnormal, pain in arm and chest pain to be related to Shingrix.  Additional Information: GSK Receipt Date: 10-MAY-2023 The reporter was a friend of the patient. He called the GlaxoSmithKline (GSK) and stated that, he had a friend here who got the shingles shot on Monday afternoon. He had been not feeling good. This was 2nd day now (at the time of reporting) since he got the shot. He was in severe pain today (On the day of reporting). We were wondering as what to do. It had started in his arm and goes across his chest. He just did not felt good, at all. The patient was here at his house. The reporter had denied consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness at the injection site after first dose of Shingrix; 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 an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Soreness at the injection site after first dose of Shingrix). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAY-2023 The patient received 1st dose of Shingrix and experienced soreness at the injection site. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Vaccination failure
Clinical narrative: last few months she has had 3 or 4 cases of shingles/ Suspected vaccination failure; she has had 3 or 4 cases of shingles; blistery rashes; painful; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   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: last few months she has had 3 or 4 cases of shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: she has had 3 or 4 cases of shingles), blistery rash (Verbatim: blistery rashes) and pain (Verbatim: painful). The patient was treated with medication unknown (Topical Cream (Nos)). The outcome of the vaccination failure, blistery rash and pain were unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blistery rash and pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, blistery rash and pain to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 10-MAY-2023. The patient stated she had both doses of the Shingrix vaccination a few years ago.   States in the last few months she has had 3 or 4 cases of shingles.   The symptoms were painful, blistery rashes.   The patient had been treated by her primary care physician with each outbreak. A cream was prescribed for topical use to help decrease the pain.   No further information was known. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter did not consent to follow-up.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient was administered a pediatric dose of Engerix-B; Adult patient was administered a pediatric dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31-MAR-2024) for prophylaxis.   On 10-MAY-2023, the patient received Engerix B pediatric. On 10-MAY-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Adult patient was administered a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: Adult patient was administered a pediatric dose of Engerix-B). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 10-MAY-2023 The pharmacist informed that earlier on the day of reporting, a patient was administered a pediatric dose of Engerix-B. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstitution of Hiberix with other Liquid Diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-month-old male patient who received Hib (Hiberix) (batch number 4SM94, expiry date 18-APR-2024) for prophylaxis.   On 27-APR-2023, the patient received Hiberix. On 27-APR-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstitution of Hiberix with other Liquid Diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-MAY-2023 The reporter stated that one of her colleagues, a Medical Assistant, reconstituted Hiberix with the other diluent that came with MMR vaccine from Merck Company and administered to a kid which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The patient had no side effects. The reporter consented to follow up.
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was accidentally given a dose of Infanrix instead of Boostrix; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 33-year-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 06-APR-2023, the patient received Infanrix. On 06-APR-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: patient was accidentally given a dose of Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-MAY-2023 A nurse called to report that a patient was accidentally given a dose of Infanrix instead of Boostrix. The reporter requested to know how to proceed with the vaccinations. They were unsure of previous vaccines given or current vaccination status.  Vaccine, patient and vaccination information was provided. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. The reporter reported that a 33 year old patient was given Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: DTAP, DTAPIPV, HEP, HEPA, MENB, TDAP
Symptoms: Product storage error
Clinical narrative: Bexsero/ Boostrix/ Engerix B/ Havrix/ Kinrix/ Infanrix + Administration to patient after Below Temperature Excursion.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Bexsero, Boostrix, Engerix B, Kinrix, Infanrix and Havrix. On an unknown date, an unknown time after receiving Bexsero, Boostrix, Engerix B, Kinrix, Infanrix and Havrix, the patient experienced incorrect storage of drug (Verbatim: Bexsero/ Boostrix/ Engerix B/ Havrix/ Kinrix/ Infanrix + Administration to patient after Below Temperature Excursion.). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-MAY-2023 The clinical manager reported that vaccines Bexsero, Boostrix, Engerix B, Havrix, Kinrix, Infanrix   were exposed to minimum temperature of -148.3°F. It was determined that the vaccines were not stable at that temperature.  The temperature excursion occurred in December, since then, the clinic has been administering the unstable vaccines to patient.  The reporter mentioned that will callback to provide information about patients and administration dates as well as lot number and expiration. Yet no call was returned.  Till the time they don't know how many patients were involved. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.  The patient received Bexsero, Boostrix, Engerix B, Havrix, Kinrix, Infanrix below temperature excursion which led to incorrect storage of drug.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the liquid component of Menveo was administered; Only the liquid component of Menveo was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA977A, expiry date 31-MAY-2024) for prophylaxis.   On 08-MAY-2023, the patient received Menveo. On 08-MAY-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only the liquid component of Menveo was administered) and inappropriate dose of vaccine administered (Verbatim: Only the liquid component of Menveo was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-MAY-2023 The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. The patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix adjuvant only administered; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number HL9AJ, expiry date 04-AUG-2024) for prophylaxis.   On 12-MAY-2023, the patient received Shingrix. On 12-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix adjuvant only administered) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-MAY-2023 The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was same as the primary reporter. The reporter did not consent to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Dose of Shingrix which had been reconstituted with sterile water; Accidentally given a dose of Shingrix which had been reconstituted with sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 2YS59, expiry date 08-FEB-2024) for prophylaxis.   On 12-MAY-2023, the patient received Shingrix. On 12-MAY-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Dose of Shingrix which had been reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Accidentally given a dose of Shingrix which had been reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date:12-MAY-2023 HCP called in to report that a patient was accidentally given a dose of Shingrix which had been reconstituted with sterile water. They asked for medical information, accepting it be sent and gave information about patient, vaccine and vaccination. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented for follow up. The patient accidentally received a dose of Shingrix which had been reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Had flu like symptoms; Muscle aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. In SEP-2022, an unknown time after receiving Shingrix and SHINGRIX, the patient experienced influenza-like symptoms (Verbatim: Had flu like symptoms) and muscle pain (Verbatim: Muscle aches). The outcome of the influenza-like symptoms and muscle pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and muscle pain to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms and muscle pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAY-2023 The consumer reported that he received two doses of Shingrix two months apart and since last September he had flu like symptoms and muscle aches.  The consumer stated he already reported this to the Centers for Disease Control (CDC) and VAERS.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: adjuvant portions of Shingrix were mixed and administered to a patient without the lyophilized powder reconstitution; adjuvant portions of Shingrix were mixed and administered to a patient without the lyophilized powder reconstitution; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number XL7RB) for prophylaxis.   On 15-MAY-2023, the patient received Shingrix. On 15-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: adjuvant portions of Shingrix were mixed and administered to a patient without the lyophilized powder reconstitution) and inappropriate dose of vaccine administered (Verbatim: adjuvant portions of Shingrix were mixed and administered to a patient without the lyophilized powder reconstitution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-May-2023 No expiration date was reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. The patient received two adjuvant portions of Shingrix were mixed without the lyophilized powder reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.