chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19-2, MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient had loss of consciousness after receiving vaccines. Provider Team responded. Patient aroused quickly. Recovered to baseline with rest and snack. Patient had not eaten prior to visit.
Age: 58.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Erythema, Feeling abnormal, Pain in extremity, Skin warm
Clinical narrative: Pt reported feeling "hit by a truck" after getting vaccines on 4/9/24. Sore, itchy, red and warm to touch on LEFT arm. [Vaccines were administered to RIGHT arm.] Pt worried it may be a blood clot and not a reaction due to family history. Pt was started on keflex on 4/13/24 after being seen in a walk in clinic.   On 4/14/25 pt was seen in the context of a specialty provider appt for con't complaints to pain in her left arm. Erythema and warmth measuring 13 cm x 15 cm. Radial pulse strong. No finger edema. Pt reported feeling overall better than when she was seen on 4/13/23. Pt deferred primary care appt to f/u and chose to go to the ED for u/s imaging which was negative. Pt completed abx course and symptoms resolved.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects noted
Age: 16.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: Pt already had a MMR Vaccine on 8/23/23 and did not need this vaccine. This was a medication error on our nurse. The family requested the child have MMR and COVID, but the nurse did not verify until after giving the vaccine the child's vaccine history.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Intussusception, Pneumonia
Clinical narrative: CLIENTS MOTHER STATED THAT CHILD HAD BEEN HOSPITALIZED FOR PNEUMONIA AND LATER FOUND CHILD HAD INTUSSUSCEPTION OF THE BOWEL SHORTLY AFTER 1ST BIRTHDAY.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alcohol use, Angiocardiogram, COVID-19, Cardiac failure, Catheterisation cardiac abnormal
Clinical narrative: PFIZER #1 12/8/2021 PFIZER #2 1/5/2022 DEVELOPED SEVERE COVID19 ILLNESS IN 2022 WITH FAILURE OF THE VACCINES AND IN 2023 DEVELOPED HEART FAILURE WITH LVEF 35% FOUND TO BE GENETIC POSITIVE HETEROZYGOUS AUTO DOMINANT FOR DILATED CARDIOMYOPATHY.  HEART CATHETERIZATION FOUND MILD CAD.   MRI SHOWED LVEF 45% WITH NO LGE.  ECHO LVEF 45% 4/30/2024 NO PERICARDIAL EFFUSION.  DIAGNOSIS IS COVID VACCINE SUBCLINICAL MYOCARDITIS WORSENED BY GENETIC PREDISPOSITION AND ALCOHOL.   STOPPED ALCOHOL, TREATED WITH LOSARTAN, SPIRONOLACTON, CARVEDILOL, LASIX, AND PROTOCOL BASE SPIKE DETOXIFICATION.  LVEF IMPROVE
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coronary artery disease, Cytogenetic analysis abnormal, Detoxification, Dilated cardiomyopathy, Echocardiogram abnormal
Clinical narrative: PFIZER #1 12/8/2021 PFIZER #2 1/5/2022 DEVELOPED SEVERE COVID19 ILLNESS IN 2022 WITH FAILURE OF THE VACCINES AND IN 2023 DEVELOPED HEART FAILURE WITH LVEF 35% FOUND TO BE GENETIC POSITIVE HETEROZYGOUS AUTO DOMINANT FOR DILATED CARDIOMYOPATHY.  HEART CATHETERIZATION FOUND MILD CAD.   MRI SHOWED LVEF 45% WITH NO LGE.  ECHO LVEF 45% 4/30/2024 NO PERICARDIAL EFFUSION.  DIAGNOSIS IS COVID VACCINE SUBCLINICAL MYOCARDITIS WORSENED BY GENETIC PREDISPOSITION AND ALCOHOL.   STOPPED ALCOHOL, TREATED WITH LOSARTAN, SPIRONOLACTON, CARVEDILOL, LASIX, AND PROTOCOL BASE SPIKE DETOXIFICATION.  LVEF IMPROVE
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ejection fraction decreased, Electrocardiogram, Laboratory test, Magnetic resonance imaging heart abnormal, Myocarditis
Clinical narrative: PFIZER #1 12/8/2021 PFIZER #2 1/5/2022 DEVELOPED SEVERE COVID19 ILLNESS IN 2022 WITH FAILURE OF THE VACCINES AND IN 2023 DEVELOPED HEART FAILURE WITH LVEF 35% FOUND TO BE GENETIC POSITIVE HETEROZYGOUS AUTO DOMINANT FOR DILATED CARDIOMYOPATHY.  HEART CATHETERIZATION FOUND MILD CAD.   MRI SHOWED LVEF 45% WITH NO LGE.  ECHO LVEF 45% 4/30/2024 NO PERICARDIAL EFFUSION.  DIAGNOSIS IS COVID VACCINE SUBCLINICAL MYOCARDITIS WORSENED BY GENETIC PREDISPOSITION AND ALCOHOL.   STOPPED ALCOHOL, TREATED WITH LOSARTAN, SPIRONOLACTON, CARVEDILOL, LASIX, AND PROTOCOL BASE SPIKE DETOXIFICATION.  LVEF IMPROVE
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: PFIZER #1 12/8/2021 PFIZER #2 1/5/2022 DEVELOPED SEVERE COVID19 ILLNESS IN 2022 WITH FAILURE OF THE VACCINES AND IN 2023 DEVELOPED HEART FAILURE WITH LVEF 35% FOUND TO BE GENETIC POSITIVE HETEROZYGOUS AUTO DOMINANT FOR DILATED CARDIOMYOPATHY.  HEART CATHETERIZATION FOUND MILD CAD.   MRI SHOWED LVEF 45% WITH NO LGE.  ECHO LVEF 45% 4/30/2024 NO PERICARDIAL EFFUSION.  DIAGNOSIS IS COVID VACCINE SUBCLINICAL MYOCARDITIS WORSENED BY GENETIC PREDISPOSITION AND ALCOHOL.   STOPPED ALCOHOL, TREATED WITH LOSARTAN, SPIRONOLACTON, CARVEDILOL, LASIX, AND PROTOCOL BASE SPIKE DETOXIFICATION.  LVEF IMPROVE
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; HBP called to report inadvertent administration of VARIVAX on 16FEB2024 after a temperature excursion.; This spontaneous report was received from a health business professional (HBP) referring to a patient of unknown gender and age. The patient's medical history, concurrent condition and concomitant therapies were not reported.  On 16-FEB-2024, the patient was inadvertently administered of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot #X017484 has been verified to be a valid lot number, expiration date reported as 25-FEB-2025, and upon internal validation established as 25-JUN-2025, for prophylaxis (strength, dose, frequency, and route of administration were not provided), after a temperature excursion (product storage error). Temperature excursion as following: 6 Fahrenheit (F) up to 14 F (9.9F) for 28 minutes; 14 F up to 46 F (21.6F) for 54 minutes. There was no previous temperature excursion. No additional adverse event (AE)/ product quality concern (PQC) (no adverse event) was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Pharmacist calling to report inadvertently administered an expired dose of MMRII to a patient; This spontaneous report was received from a pharmacist and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 05-APR-2024, the patient was inadvertently vaccinated with expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin)(M-M-R II) one dose, lot # reported and confirmed as: W002787, expiration date reported and confirmed as: 25-JAN-2024 (exact dose, site and route of administration were not provided) for prophylaxis. The vaccine did not undergo any temperature excursions and was supported by post-expiry memo. There was no additional adverse event reported.
Age: 1.17
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse event; HCP called to report inadvertent administration of PROQUAD and VARIVAX to a patient on 12APR2024. Patient was scheduled to receive their first dose of MMR-II and VARIVAX but instead was inadvertently given a first dose of PROQUAD and VARIVAX. No addi; This spontaneous report was received from medical assistant and refers to a 14-month-old patient of unspecified gender.No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On 12-APR-2024, the patient was inadvertent vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (strength, dose, lot #, expiry date, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, both administered for prophylaxis (strength,  dose, lot #, expiry date, and route of administration were not provided). Patient was scheduled to receive their first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R-II) and varicella virus vaccine live (oka/merck) (VARIVAX) but received aforementioned regimen (wrong product administered). No additional adverse event.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller stated no patient symptoms have been reported/No additional AE; Adverse event originally reported for multiple patients in AE case #02586325 on 4/16/2024. During customer follow up on 4/23/2024, pharmacist provided specific patient information (patient initials and administration date) so new case opened. Pharmac; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.   On 15-MAR-2024, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number X018583, expiration date was reported and validated as 05-JAN-2025) as prophylaxis, that had been involved in a temperature excursion (product storage error). No additional adverse event (AE).  The vaccine experienced a temperature excursion at minus (-) 8 degrees Celsius (C) for 105 hours and there was a cumulative excursion time provided, where the products were involved in multiple excursions starting sometime in March 2024 but the data logger did not break down the excursion any further.  This is one of three reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; expired dose of ROTATEQ that was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  On 23-APR-2024, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, oral, lot # 1932216, expiration date: 12-APR-2024, three dose series (strength and dose number were not provided) for prophylaxis (expired product administered).  The nurse confirmed the patient did not experience any medical concerns or symptoms after being administered the expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ)
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Immunisation reaction, Serum sickness
Clinical narrative: allergy to pneumovax23; serum sickness; This spontaneous report was received from Other Health Professional and refers to a 78-year-old female.  The patient's medical history included  gastrooesophageal reflux disease,  hyperlipidaemia,  liver disorder,  obstructive sleep apnea syndrome,  peripheral vascular disorder,  ventricular tachycardia,  ulcerative pancolitis,  benign essential hypertension, and diverticulosis. The patient's concurrent conditions included  diabetes. Historical drugs included  statins, and tramadol. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced allergy to vaccine and serum sickness. At the time of reporting, the outcome of the events was not known.   The reporter considered all adverse events to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still break out just not as bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still break out just not as bad). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 20-APR-2024 This case was reported by a patient via interactive digital media. The reporter stated that he/she had the vaccinations and still broke out just not as bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Breast tenderness, Confusional state, Fatigue, Headache
Clinical narrative: Headache; Confusion; Lymph node pain; Tenderness breast; Armpit pain; Enlargement of lymph nodes; Nausea; General malaise; Fatigue; This non-serious case was reported by a consumer and described the occurrence of headache in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis. Concomitant products included celecoxib.   On 12-APR-2024, the patient received the 1st dose of Shingrix. On 12-APR-2024, less than a day after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), general malaise (Verbatim: General malaise) and fatigue (Verbatim: Fatigue). On 13-APR-2024, the patient experienced headache (Verbatim: Headache), confusion (Verbatim: Confusion), lymph node pain (Verbatim: Lymph node pain), breast tenderness (Verbatim: Tenderness breast), axillary pain (Verbatim: Armpit pain) and enlargement of lymph nodes (Verbatim: Enlargement of lymph nodes). The outcome of the headache, nausea, general malaise, fatigue, confusion, lymph node pain, breast tenderness, axillary pain and enlargement of lymph nodes were not resolved.   It was unknown if the reporter considered the headache, nausea, general malaise, fatigue, confusion, lymph node pain, breast tenderness, axillary pain and enlargement of lymph nodes to be related to Shingrix.     It was unknown if the company considered the headache, nausea, general malaise, fatigue, confusion, lymph node pain, breast tenderness, axillary pain and enlargement of lymph nodes to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-APR-2024 The patient self reported this case for herself. The reporter received 1st dose of Shingrix. The reporter experienced headache, nausea, general malaise, fatigue, confusion, lymph node pain, tenderness breast, armpit pain and enlargement of lymph nodes. The reporter received Celecoxib as concomitant medication. The reporter reported that the symptoms were not treated. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Malaise, Nausea
Clinical narrative: Headache; Confusion; Lymph node pain; Tenderness breast; Armpit pain; Enlargement of lymph nodes; Nausea; General malaise; Fatigue; This non-serious case was reported by a consumer and described the occurrence of headache in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis. Concomitant products included celecoxib.   On 12-APR-2024, the patient received the 1st dose of Shingrix. On 12-APR-2024, less than a day after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), general malaise (Verbatim: General malaise) and fatigue (Verbatim: Fatigue). On 13-APR-2024, the patient experienced headache (Verbatim: Headache), confusion (Verbatim: Confusion), lymph node pain (Verbatim: Lymph node pain), breast tenderness (Verbatim: Tenderness breast), axillary pain (Verbatim: Armpit pain) and enlargement of lymph nodes (Verbatim: Enlargement of lymph nodes). The outcome of the headache, nausea, general malaise, fatigue, confusion, lymph node pain, breast tenderness, axillary pain and enlargement of lymph nodes were not resolved.   It was unknown if the reporter considered the headache, nausea, general malaise, fatigue, confusion, lymph node pain, breast tenderness, axillary pain and enlargement of lymph nodes to be related to Shingrix.     It was unknown if the company considered the headache, nausea, general malaise, fatigue, confusion, lymph node pain, breast tenderness, axillary pain and enlargement of lymph nodes to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-APR-2024 The patient self reported this case for herself. The reporter received 1st dose of Shingrix. The reporter experienced headache, nausea, general malaise, fatigue, confusion, lymph node pain, tenderness breast, armpit pain and enlargement of lymph nodes. The reporter received Celecoxib as concomitant medication. The reporter reported that the symptoms were not treated. The reporter consented to follow up.
Sex: U
Vaccine: RVX
Symptoms: Burning sensation, Injection site pain, Pain
Clinical narrative: Burning/it was a burning; Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced burning sensation (Verbatim: Burning/it was a burning) and pain (Verbatim: Pain). The outcome of the burning sensation and pain were not reported.   It was unknown if the reporter considered the burning sensation and pain to be related to RSV vaccine.     It was unknown if the company considered the burning sensation and pain to be related to RSV vaccine.   Additional Information: GSK receipt date: 18-APR-2024 This case was reported by a patient via interactive digital media. The patient received RSV vaccine and stated that it was a burning of a shot. The reporter stated that it was well worth the pain though.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Oropharyngeal pain
Clinical narrative: Sore throat; Achey joints; This non-serious case was reported by a consumer via call center representative and described the occurrence of sore throat in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced sore throat (Verbatim: Sore throat) and joint pain (Verbatim: Achey joints). The outcome of the sore throat and joint pain were not reported.   It was unknown if the reporter considered the sore throat and joint pain to be related to Shingrix.     It was unknown if the company considered the sore throat and joint pain to be related to Shingrix.   Additional Information: GSK receipt date: 18-APR-2024 The reporter reported that a patient received Shingrix vaccine and five days after receiving experienced sore throat and achy joints. The consent to follow up was requested.
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: they had accidentally given her daughter the vaccine before it was reconstituted; they had accidentally given her daughter the vaccine before it was reconstituted; This non-serious case was reported by a physician via other manufacturer and described the occurrence of inappropriate preparation of medication in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 17-APR-2024, the patient received Menveo. On 17-APR-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: they had accidentally given her daughter the vaccine before it was reconstituted) and inappropriate dose of vaccine administered (Verbatim: they had accidentally given her daughter the vaccine before it was reconstituted). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-APR-2024 The consumer called and stated that her daughter received a vaccine for meningococcal at her pediatrician's office. On 18-APR-2024, the mother received a call from the office stating that they had accidentally given her daughter the vaccine before it was reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The office had the patient came back in, so that she could get the reconstituted vaccine on 18-APR-2024. When asked the reporter what the name of the vaccine was, she said it was Menveo.
Sex: U
Vaccine: DTAPIPV, FLU4, HEP, HEPA, RV1, UNK
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis and Rotavirus vaccine live oral 1v (Rotarix prefilled) for prophylaxis.   On an unknown date, the patient received Kinrix, Engerix B, Havrix, Fluarix Tetra, Rotarix lyophilized formulation and Rotarix prefilled. On an unknown date, an unknown time after receiving Kinrix, Engerix B, Havrix, Fluarix Tetra, Rotarix lyophilized formulation and Rotarix prefilled, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). 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: 17-APR-2024 The registered nurse called to report the that he/she was looking at some of the data from a temperature excursion that he/she had called in, in January and the temperature he/she had reported was 1.8 that actually had to be negative 1.8, which led incorrect storage of drug. It was reported that vaccine stored outside recommended conditions and administered to patient. The registered nurse R(N) declined safety follow-up since she was going to report by her side, on her clinic's system. The reporter did not consent to follow-up.
Age: 0.17
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: 9 month old female was given an extra dose of hep. B vaccine; had second and third doses on 31Aug2023 and 10Jan2024; had first and second doses on 27Jun2023, 31Aug2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 9-week-old female patient who received HBV (Engerix B) (batch number 9237Y, expiry date 27-OCT-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B).   On 16-APR-2024, the patient received the 4th dose of Engerix B. On 10-JAN-2024, the patient received the 3rd dose of Engerix B. On 31-AUG-2023, the patient received the 2nd dose of Engerix B. On 31-AUG-2023, not applicable after receiving Engerix B and Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: had first and second doses on 27Jun2023, 31Aug2023). On 10-JAN-2024, the patient experienced drug dose administration interval too long (Verbatim: had second and third doses on 31Aug2023 and 10Jan2024). On 16-APR-2024, the patient experienced extra dose administered (Verbatim: 9 month old female was given an extra dose of hep. B vaccine). The outcome of the extra dose administered, drug dose administration interval too long and drug dose administration interval too long 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: 17-APR-2024. Nurse reported that the patient was given an extra dose (fourth dose) of hepatitis B vaccine, which led to extra dose administered. The patient received second and third dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pruritus
Clinical narrative: after injection he had itching on random parts of the body; patient did not recived 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 08-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, several days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pruritus (Verbatim: after injection he had itching on random parts of the body) and incomplete course of vaccination (Verbatim: patient did not recived 2nd dose yet). The outcome of the pruritus was resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.     It was unknown if the company considered the pruritus to be related to Shingrix.   Additional Information: GSK receipt date: 17-APR-2024 The reporter reported that he had received first dose of Shingrix vaccine. The reporter reported that he got the vaccine at a local pharmacy and the vaccine was administered by the pharmacist. The patient reports that a few days after injection he had itching on random parts of his body. Patient reports that the itching was random and for a short duration. The patient mentioned that he was late for about 9 days from the 6-month window for the 2nd dose and did not receive it which led to, incomplete course of vaccination. The reporter mentioned that the lot number and expiry date was unknown. The reporter consented to the follow up.
Sex: U
Vaccine: HEP
Symptoms: Therapy non-responder
Clinical narrative: Had several employees who have not seroconverted with Engerix-B; This non-serious case was reported by a other health professional via sales rep and described the occurrence of therapy non-responder in an unspecified number of patient's who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced therapy non-responder (Verbatim: Had several employees who have not seroconverted with Engerix-B). The outcome of the therapy non-responder 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: 17-APR-2024 The reporter reported that a couple of their provider requested the efficacy data because they have had several employee who had not seroconverted with Engerix-B, which led to therapy non responder. The reporter consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B They gave the 10 micrograms and it should have been the 20; a pharmacist gave a pediatric hepatitis B vaccine to an adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 24-year-old female patient who received HBV (Engerix B pediatric) (batch number 32M5G, expiry date 14-SEP-2025) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Engerix-B They gave the 10 micrograms and it should have been the 20) and adult use of a child product (Verbatim: a pharmacist gave a pediatric hepatitis B vaccine to an adult). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-APR-2024 The reporter called to report that they got an incident there in there pharmacy, a pharmacist gave a pediatric hepatitis B vaccine to an adult. They administered the 10 micrograms instead of the recommended 20 required, the patient was 24 and looks like the pharmacist accidentally gave the wrong the pediatric dose to the patient which led to adult use of a child product and accidental underdose. They gave the 10 micrograms and it should had been the 20, Looks like the patient came in to get the hepatitis B vaccine and looks like the technician who was helping him, put it wrong into the system so verified and bypassed. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: rash; gets itchy in the middle of the day/late afternoon; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2024, the patient received the 2nd dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced rash (Verbatim: rash) and itchy rash (Verbatim: gets itchy in the middle of the day/late afternoon). The outcome of the rash was not resolved and the outcome of the itchy rash was not reported.   It was unknown if the reporter considered the rash and itchy rash to be related to Shingrix.     It was unknown if the company considered the rash and itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2024. Reporter was the patient who received her second dose of Shingrix in March.  1 week later, patient broke out with a rash underneath her arm, on her side, in front of her leg, and on her forearm.  Patient saw a family care doctor who gave her a steroid cream. It helped a little but the rash came back.  Patient stated that the rash gets itchy in the middle of the day or late afternoon.  Patient did not provide demographic information.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Eye swelling, Herpes zoster, Scab, Skin graft
Clinical narrative: One big black scab the size of my hand and a scab on the end of my eye lid; redness; I still have the swelling had to have a skin graph on my eye to close my eye; I got Shingles on my head; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAY-2023, the patient received the 1st dose of Shingrix. On 15-MAY-2023, 14 days after receiving Shingrix, the patient experienced shingles (Verbatim: I got Shingles on my head). On an unknown date, the patient experienced scab (Verbatim: One big black scab the size of my hand and a scab on the end of my eye lid), erythema (Verbatim: redness) and eye swelling (Verbatim: I still have the swelling had to have a skin graph on my eye to close my eye). The outcome of the shingles, scab, erythema and eye swelling were not resolved.   It was unknown if the reporter considered the shingles, scab, erythema and eye swelling to be related to Shingrix.     It was unknown if the company considered the shingles, scab, erythema and eye swelling to be related to Shingrix.   Additional Information: GSK receipt date: 18-APR-2024 The reporter was the patient he stated he had received first dose of Shingrix vaccine and had not received the second dose yet. The patient stated that he got Shingles on his head and on the left side of his left eye his eyebrow down his nose and side his inose all the way back to his crown. The reporter stated that one big black scab the size of his hand and a scab on the end of his eye lid. The scab was now gone, but he still had the redness and swelling had to a skin graph on his eye to close eye. The patient stated that he was still fighting the effects. he had 8 doctors tell him it was the worst case they had ever seen. The reporter consented to the follow up.
Age: 5.0
Sex: F
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: Overdose of DTaP; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 5-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 77J49, expiry date 09-FEB-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number TX77L, expiry date 01-DEC-2025) for prophylaxis.   Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (DTaP vaccine).   On 17-APR-2024, the patient received Pediarix and Infanrix. On 17-APR-2024, an unknown time after receiving Pediarix and Infanrix, the patient experienced overdose (Verbatim: Overdose of DTaP). The outcome of the overdose 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: 18-APR-2024. Nurse reports 5-year-old female patient was administered a dose of Infanrix and Pediarix on the same day so therefore received extra dose of DTaP which led to overdose.   the patient had one DTaP vaccine, which was administered on 05-Mar-2024. The vaccine administration facility was the same as primary reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired dose of Kinrix (4 days ago) was administered; 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 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 18-APR-2024, the patient received Kinrix. On 18-APR-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose of Kinrix (4 days ago) was administered). 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: 18-APR-2024 The medical assistant reported that an expired dose of Kinrix (4 days ago) was administered to a patient today (on the day of reporting). The vaccine administration facility was the same as primary reporter.
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: one of my nurses gave Kinrix to a 6 month old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 15-APR-2024, the patient received Kinrix. On 15-APR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: one of my nurses gave Kinrix to a 6 month old). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-APR-2024 A medical assistant called to inform the following about Kinrix that he/she was going through their vaccine papers and saw that they had given an incorrect dose to a patient. One of their nurses gave Kinrix to a 6 month old and they thought they were trying to combine the vaccines the best they could, which led to inappropriate age at vaccine administration. The patient was not due for Hepatitis-B at the time, so she could not give Vaxelis, what was what they carry here, and so in order to combine them she gave the Kinrix instead. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, Pyrexia
Clinical narrative: patient was accidently given an expired dose of KINRIX; fever; This non-serious case was reported by a nurse via call center representative and described the occurrence of fever in a patient who received DTPa-IPV (Kinrix) (batch number g9n2m, expiry date 14-APR-2024) for prophylaxis.   On 17-APR-2024, the patient received Kinrix. In APR-2024, an unknown time after receiving Kinrix, the patient experienced fever (Verbatim: fever). On 17-APR-2024, the patient experienced expired vaccine used (Verbatim: patient was accidently given an expired dose of KINRIX). The outcome of the fever was not reported and the outcome of the expired vaccine used was unknown.   It was unknown if the reporter considered the fever to be related to Kinrix and Kinrix Pre-Filled Syringe Device.     It was unknown if the company considered the fever to be related to Kinrix and Kinrix 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: 18-APR-2024 The nurse reported that the patient was accidently given an expired dose of Kinrix vaccine which led to expired vaccine used. The patient developed a fever after administration of vaccine. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersomnia, Loss of personal independence in daily activities, Malaise, Nausea
Clinical narrative: sore injected arm; swollen injected arm; nausea; Ca not seem to stay awake, sleeping all the time; cannot perform daily tasks such as going to the laundromat / does not want to move; Headache; so sick; Temperature (high) fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of pain in extremity (received on an unknown date and had swollen arm for 1 day) and shingrix with an associated reaction of pain in extremity (received on an unknown date and had swollen arm, refer case US2024AMR050304). Concurrent medical conditions included cancer (cancer survivor) and lymphedema (swelling in legs).   On 15-APR-2024, the patient received the 2nd dose of Shingrix (intramuscular). In APR-2024, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore injected arm), swelling arm (Verbatim: swollen injected arm), nausea (Verbatim: nausea), sleepiness (Verbatim: Ca not seem to stay awake, sleeping all the time), activities of daily living impaired (Verbatim: cannot perform daily tasks such as going to the laundromat / does not want to move), fever (Verbatim: Temperature (high) fever), headache (Verbatim: Headache) and sickness (Verbatim: so sick). Rechallenge with Shingrix was positive. In APR-2024, the outcome of the fever was resolved (duration 3 days). The outcome of the pain in arm, swelling arm, nausea, sleepiness, activities of daily living impaired, headache and sickness were not resolved.   The reporter considered the pain in arm, swelling arm, nausea, sleepiness, activities of daily living impaired, fever, headache and sickness to be related to Shingrix.     The company considered the pain in arm, swelling arm, nausea, sleepiness, activities of daily living impaired, fever, headache and sickness to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR050304   Additional Information: GSK Receipt Date: 18-APR-2024 The reporter was the patient. She reported that in the past when she received a flu shot that the injected arm was sore and swollen for one day. She reported that she received Shingrix vaccine and the injected arm was still swollen and sore on the day of reporting on 18th April 2024. She was also experiencing other reactions to Shingrix vaccine nausea, could not seemed to stay awake, sleeping all the time, could not perform daily tasks such as going to the laundromat, temperature (fever) for the first three days then resolved and had headache. She said she was so sick and did not wanted to move but she has things she wanted/needed to do. The reporter did not consent to follow-up. She did not wanted to share her doctor of medicine (MD) contact information with GSK.; Sender's Comments:  US-GSK-US2024AMR050304:Same patient/same reporter/Dose 1
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: sore injected arm; swollen injected arm; nausea; Ca not seem to stay awake, sleeping all the time; cannot perform daily tasks such as going to the laundromat / does not want to move; Headache; so sick; Temperature (high) fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of pain in extremity (received on an unknown date and had swollen arm for 1 day) and shingrix with an associated reaction of pain in extremity (received on an unknown date and had swollen arm, refer case US2024AMR050304). Concurrent medical conditions included cancer (cancer survivor) and lymphedema (swelling in legs).   On 15-APR-2024, the patient received the 2nd dose of Shingrix (intramuscular). In APR-2024, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore injected arm), swelling arm (Verbatim: swollen injected arm), nausea (Verbatim: nausea), sleepiness (Verbatim: Ca not seem to stay awake, sleeping all the time), activities of daily living impaired (Verbatim: cannot perform daily tasks such as going to the laundromat / does not want to move), fever (Verbatim: Temperature (high) fever), headache (Verbatim: Headache) and sickness (Verbatim: so sick). Rechallenge with Shingrix was positive. In APR-2024, the outcome of the fever was resolved (duration 3 days). The outcome of the pain in arm, swelling arm, nausea, sleepiness, activities of daily living impaired, headache and sickness were not resolved.   The reporter considered the pain in arm, swelling arm, nausea, sleepiness, activities of daily living impaired, fever, headache and sickness to be related to Shingrix.     The company considered the pain in arm, swelling arm, nausea, sleepiness, activities of daily living impaired, fever, headache and sickness to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR050304   Additional Information: GSK Receipt Date: 18-APR-2024 The reporter was the patient. She reported that in the past when she received a flu shot that the injected arm was sore and swollen for one day. She reported that she received Shingrix vaccine and the injected arm was still swollen and sore on the day of reporting on 18th April 2024. She was also experiencing other reactions to Shingrix vaccine nausea, could not seemed to stay awake, sleeping all the time, could not perform daily tasks such as going to the laundromat, temperature (fever) for the first three days then resolved and had headache. She said she was so sick and did not wanted to move but she has things she wanted/needed to do. The reporter did not consent to follow-up. She did not wanted to share her doctor of medicine (MD) contact information with GSK.; Sender's Comments:  US-GSK-US2024AMR050304:Same patient/same reporter/Dose 1
Age: 60.0
Sex: M
Vaccine: HEPAB
Symptoms: Product storage error
Clinical narrative: Product Storage Error; 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 a 60-year-old male patient who received HAB (Twinrix) (batch number 429JJ, expiry date 01-APR-2026) for prophylaxis.   On 08-APR-2024, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). 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: 18-APR-2024 The clinical operation director stated that she went to one of their clinical sites on 16th April 2024 and discovered that vaccine fridge was set on coldest setting and the temperature was reading at minus 4 degree Celsius. She stated the medical assistant at that facility had not documented a temperature recording since 5th April 2024, so she was unsure how long the temperature was out of range. The reporter stated since the last recorded temperature reading, there was 1 administration of Twinrix vaccine to a patient, which led to incorrect storage of drug. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: that vaccine fridge was set on coldest setting and the temperature was reading at -4 Celsius; 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 a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number ZF5C7, expiry date 13-OCT-2025) for prophylaxis.   On 05-APR-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: that vaccine fridge was set on coldest setting and the temperature was reading at -4 Celsius). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 18-APR-2024 Clinical Operations Director stated she went to one of their clinical sites on 16th April 2024 and discovered that vaccine fridge was set on coldest setting and the temperature was reading at minus 4 Celsius.  She stated the Medical Assistant at that facility had not documented a temperature recording since 5th April 2024, so she is unsure how long the temperature was out of range. There was a dose administered to a patient. At the time of reporting, the dose has not been repeated. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. This case was linked to case US2024050064 and US2024050070 via E2B Linked Report considering Same reporter and Different patient.; Sender's Comments:  US-GSK-US2024050064:Same reporter/Different patient US-GSK-US2024050070:Same reporter/Different patient