chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired vaccine, waited 15 mins after vaccine was given and did not have any symptoms after receiving the vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Laboratory test, Postural orthostatic tachycardia syndrome, Tilt table test
Clinical narrative: Dizzy, light  headed after shot. Had to sit for 15 min after. Felt dizzy for a while after. 10 days later developed postural tachycardia and was hospitalized. Have had POTS symptoms for 14 months. Neurologist today diagnosed POTS from vaccine injury.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient reports that about 2 hours after the vaccine was administered in his right arm, he had pain at the injection site and a bump developed.  He  reports that some blood drained from the bump yesterday (5/18/25).  He presented to the office today to get checked.  There was an approximately 1 cm diameter pink raised and indurated area at the right upper arm.  He had been given MenQuadfi at the left arm and no reaction was noted.  He does have underlying eczema and keratosis pilaris for which he uses the prescription steroid creams.  He was also diagnosed with nickel allergy on the same day as his vaccination appointment and the rash on his belly improved greatly with changing to a belt with a plastic rather than a metal buckle. He was prescribed mupirocin ointment to use on the reddened area and instructed to start duricef by mouth if the area of redness became larger.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects or symptoms reported; patient received a dose of expired PROQUAD; This spontaneous report was received from a nurse and refers to a 5-year-old female patient. Her concurrent conditions, medical history and concomitant therapies were not provided. On 24-APR-2025, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine  (PROQUAD) 0.5 ml, lot # X024913, expiration date 14-APR-2025 (Expired product administered). No adverse events were reported.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product container issue
Clinical narrative: he might have been exposed to the product as he picked up the glass with his fingers.; Caller initially stated that he had a vial of VARIVAX that was cracked. Upon asking further questions, the HBP stated that the vial was actually broken into two of more pieces and was held together by the sticker with the product information; No additional AE/PQC; This spontaneous report was received from a consumer or other non-health professional and refers to a male patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #y017063, expiration date: 11-Oct-2026) for an unknown indication. On an unknown date, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported).  On an unknown date, patient stated that he had a vial of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #y017063, expiration date: 11-Oct-2026) that was cracked. The vial was actually broken into two of more pieces and was held together by the sticker with the product information (Product container issue). Caller stated that there was no injury or missed doses, but he might have been exposed to the product as he picked up the glass with his fingers (Occupational exposure to product). No additional adverse event was reported.
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: Specialist called and transferred HCP on the line who stated that the adult patient received all their childhood vaccinations but showed no immunity to measles, mumps, and rubella. HCP did not have any past vaccination details and was unsure if the p; Specialist called and transferred HCP on the line who stated that the adult patient received all their childhood vaccinations but showed no immunity to measles, mumps, and rubella. HCP did not have any past vaccination details and was unsure if the p; Specialist called and transferred HCP on the line who stated that the adult patient received all their childhood vaccinations but showed no immunity to measles, mumps, and rubella. HCP did not have any past vaccination details and was unsure if the p; This spontaneous report was received from a Pharmacist and refers to an Adult patient of unknown gender (exact age unknown).   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administered with sterile diluent (MERCK STERILE DILUENT) (dose, formulation, route and site of administration, lot # and expiration date were not reported) as routine vaccinations.  It was stated that the patient had received all their childhood vaccinations, but showed no immunity to measles, mumps, and rubella (Mumps antibody test negative, Rubella antibody negative, and Measles antibody negative). The health care professional (HCP) did not have any past vaccination details and was unsure if the patient received MMR-II previously. HCP did not have any additional information on the "no immunity". No additional information. Lot # is being requested and will be submitted if received.
Age: 0.5
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no symptoms reported; patient who was inadvertently administered PROQUAD at younger than indicated age on 04/25/2025; This spontaneous report was received from a registered nurse (R. N.) concerning a 6-month-old (reported as "6-months and 8-days old") patient of unspecified gender.   The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20), and Diphtheria vaccine toxoid (+) Hepatitis b vaccine rHBsAg (yeast) (+) Pertussis vaccine acellular 3-component (+) Polio vaccine inact 3v (Vero) (+) Tetanus vaccine toxoid (Pediarix) were administered concomitantly with the suspect vaccine.  On 25-Apr-2025, the patient was inadvertently administered Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) at younger than indicated age (batch/lot number Y013573 has been verified to be a valid batch/lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, expiration date reported and upon internal validation established as 03-Feb-2026) 0.5 mL (0.5mL/dose) administered as prophylaxis (dosage regimen, anatomical location and route of administration were not reported) (product administered to patient of inappropriate age), which was diluted with sterile diluent (expiration date and lot # were not reported.)  There were no symptoms or additional adverse events (AE) details reported.  Lot # is being requested and will be submitted if received.
Age: 70.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Consumer is 70 years old and on 5/1/25 received a titer test for measles, mumps and rubella. The test showed zero immunity, so she was vaccinated with MMR-II. Caller stated that she is not aware of she ever received an MMR vaccine. States that she wa; This spontaneous report was received from a consumer or other non health professional and refers to a(n) 70-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included antibody test negative. Concomitant therapies were not reported.   On 01-May-2025, the patient received a titer test for measles, mumps and rubella. The test showed zero immunity, so she was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered for vaccination (strength, dose, route, lot# and expiation date were not reported) (Inappropriate age at vaccine administration). Reporter stated that she was not aware of she ever received an MMR vaccine and stated that she was probably not vaccinated as child, but that she cannot be sure. Her mother did not keep records and she was no longer living. No additional information on AE (No adverse event).  Lot# is being requested and will be submitted if received.
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP called to report inadvertent administration of expired MMR-II to a patient. MMR-II expired on 21MAR2025 and was administered to a patient on 28MAR2025. No additional AE/PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-Mar-2025, the patient was vaccinated with expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X008385, expiration date: 21-Mar-2025 for prophylaxis (exact dose, route of administration and anatomical location were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (expired vaccine used). No additional adverse event reported (no adverse event).
Vaccine: HEPA, HPV9, PNC15, PPV, RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; a potential adverse event regarding improperly stored and administered vaccines: ROTATEQ, VAQTA, GARDASIL 9, VAXNUEVANCE, PNEUMOVAX 23.; This spontaneous report was received from medical assistant and refers to multiple patients of unknown age and gender.   The patients' medical history, concurrent conditions and concomitant therapies were not reported.   On May-2025, the patient was vaccinated with improperly stored and administered vaccines, which underwent temperature excursion on 07-MAY-2025: Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (valid lot #Y013565, expiration date: 01-Feb-2027) 0.5 mL (Two or Three dose series), with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) (valid lot #X026480, expiration date: 12-Jan-2026) 0.5 mL (Four dose series); with Hepatitis A Vaccine, Inactivated (VAQTA) (valid lot #Y015027, expiration date: 06-Feb-2026) 0.5 mL (Two dose series), with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), (valid lot #X022827, expiration date: 14-Aug-2025) 0.5 mL (once) with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (valid lot #2032352, expiration date: 21-Oct-2025) 2 mL (three dose series) (product storage error). All suspect vaccines were administrated as prophylaxis. No additional information provided. No additional adverse event (AE) was reported. The case was considered as non-valid due to multiple patients without identifiers.
Vaccine: HEPA
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: The caller she knows it was less than the recommended dose of VAQTA; No additional AE reported.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA), (valid lot #Y013274, expiration date: 26-Dec-2025) for prophylaxis. During vaccination the patient moved. The caller said due to the child moving she believed the patient received half the dose of Hepatitis A Vaccine, Inactivated (VAQTA), but the caller did not know the exact dose amount the patient received. The caller she knew it was less than the recommended dose of Hepatitis A Vaccine, Inactivated (VAQTA) (accidental underdose). No additional adverse event (AE) was reported.
Sex: M
Vaccine: MMR, MMR, VARCEL, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; patient formerly received MMRII and VARIVAX at another clinic on 2/1/2024,; This spontaneous report was received from a medical assistant on 13-MAY-2025 and refers to a 4-year-old male patient.   The patient's medical, concurrent conditions and concomitant therapies were not reported.   On 01-FEB-2024, the patient was vaccinated at the same time with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (dose, dose number, anatomical location, route of administration, lot # and expiration date were not reported) , sterile diluent (MERCK STERILE DILUENT) (dose, dose number, anatomical location, route of administration, lot # and expiration date were not reported) ,  Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) ) (dose, dose number, anatomical location, route of administration, lot # and expiration date were not reported) and  sterile diluent (MERCK STERILE DILUENT) (dose, dose number, anatomical location, route of administration, lot # and expiration date were not reported)  for prophylaxis (Inappropriate schedule of product administration).   No additional adverse event or PQC was reported.   This is one of several report for the same patient (case #: 2286272).
Age: 7.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/No PQC reported; vaccine storage issue; This spontaneous report was received from a nurse practitioner (also was vaccine provider) and referred to a 7-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Diphtheria vaccine toxoid (+) Pertussis vaccine acellular (+) Tetanus vaccine toxoid) (TDAP) (lot# 67983AA), Hepatitis A vaccine (lot# DN273), Influenza vaccine inact split 3v (FLULAVAL) (lot# 4LM54), Polio vaccine inact (IPV) (lot# X1C891M). No illness at time of vaccination.  On 21-MAR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y013582, expiration date was reported as 02-FEB-2026, but upon internal validation established as: 03-FEB-2026; strength and dose were not reported) administered via intramuscular (IM). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). On the same day, the patient was also vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot #X002469, expiration date: 22-MAY-2025; strength and dose were not reported) via IM, all products were used for prophylaxis at a hospital clinic. The vaccines were involved in temperature excursion and storage issue (Product storage error). It was also reported it was a data logger discrepancy not a true excursion as the fridge and freezer never alarmed  At compliance visit on 09-APR-2025, upon reviewed by store, temperature excursion noted on 03-MAR-2025 to 10-MAR-2025. Upon further investigation, and reviewed by the DDL manufacturer, it was noted as a "glitch", most likely caused by an electrical interference. The VFC program advised revaccination and that process was currently in progress with the patient involved. No adverse event was reported.  This is one of several reports received from the same reporter.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia
Clinical narrative: Caller stated after leaving the office the patient lost feeling from her left elbow to her fingers, patient tried to open the car door and could not feel the handle prior to returning back in the office; This spontaneous report was received from a Nurse and refers to an 11-year-old female patient.   The patient's medical history, concurrent conditions past drug reactions and allergies were reported as no. Concomitant medications included Meningococcal vaccine A/C/Y/W conj (tet tox) (MENQUADFI) and Diphtheria vaccine toxoid (+) Pertussis vaccine acellular (+) Tetanus vaccine toxoid (TDAP).  On 08-MAY-2025, the patient visited the doctor´s office for a physical and was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) prefilled syringe, 1 dosage form, administered in the left deltoid as prophylaxis (lot number Z005055 has been verified to be valid for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date 27-FEB-2026; route of administration, exact dose and vaccination scheme frequency were not reported). On that same date, after leaving the office, the patient lost feeling from her left elbow to her fingers. Patient tried to open the car door and could not feel the handle prior to returning back in the office (Sensory loss). The patient was seen by the doctor and was given two tablets of 200mg ibuprofen as treatment for the event. Approximately 20 minutes later, there was no change; doctor then recommended hot and cold compress during the night. At approximately 19:00 on that same date, the patient´s father contacted the office and stated that hot and cold compresses were applied, and patient was able to feel a little bit. On 09-MAY-2025, approximately at 6:00, the patient´s father contacted the office again and stated the patient fully recovered from the event. No additional information provided.   The causal relationship between Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and the event of Sensory loss was not reported.
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Customer called and reported that a dose of VAXTA expired on 5/11/2025 and was administered on 5/15/2025. No temperature excursions through date of administration.; This spontaneous report was received from a physician assistant (reported as medical assistant) and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported.   On 15-May-2025, the patient was vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) 1 mL, administered as prophylaxis (Lot No. X026485 has been verified to be a valid lot number for [hepatitis a vaccine, inactivated], expiration date reported and upon internal validation established as 11-May-2025) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided) (expired product administered) No additional adverse event was reported (No adverse event).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Mobility decreased, Myalgia
Clinical narrative: had trouble lifting her arm/range of motion is not there/decreased range of motion; Injection site pain; Injection site warmth; Injection site swelling; deltoid muscle was very sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-MAY-2025, the patient received Shingrix (intramuscular, left deltoid). On 08-MAY-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain), injection site warmth (Verbatim: Injection site warmth), injection site swelling (Verbatim: Injection site swelling) and muscle soreness (Verbatim: deltoid muscle was very sore). On 09-MAY-2025, the patient experienced mobility decreased (Verbatim: had trouble lifting her arm/range of motion is not there/decreased range of motion). The outcome of the injection site pain, injection site warmth, injection site swelling, muscle soreness and mobility decreased were not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site swelling, muscle soreness and mobility decreased to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site warmth, injection site swelling, muscle soreness and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAY-2025 The patient reports that she received her Shingrix dose. That evening of vaccination she noticed pain, swelling and warmth at the injection site. The following day her left deltoid muscle was very sore and she had trouble lifting her arm. States that the range of motion was not there.  She states that all symptoms were ongoing.  She states that there was no other activity or medication that could have contributed to the symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Breast swelling, Headache
Clinical narrative: headache; swell right breast; This non-serious case was reported by a consumer and described the occurrence of breast swelling in a 67-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 05-MAY-2025, the patient received Shingles vaccine. On 06-MAY-2025, 1 days after receiving Shingles vaccine, the patient experienced breast swelling (Verbatim: swell right breast). On an unknown date, the patient experienced headache (Verbatim: headache). The outcome of the breast swelling was not resolved and the outcome of the headache was resolved with sequelae.   It was unknown if the reporter considered the breast swelling and headache to be related to Shingles vaccine.     It was unknown if the company considered the breast swelling and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAY-2025 The patient was a reporter. The patient experienced swell right breast and headache. Were the symptoms treated (swell right breast) was reported as no.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: inappropriate schedule of vaccine/never received the second shot for several reasons and didn't realize it until recently/she has not received the 2nd dose of the vaccine due to personal reasons; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th April 2023, 0.5 mL administered intramuscularly).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: inappropriate schedule of vaccine/never received the second shot for several reasons and didn't realize it until recently/she has not received the 2nd dose of the vaccine due to personal reasons). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 15-MAY-2025 The customer reported that she received the vaccine at a local pharmacy but did not recall in which arm. The patient reported that she had not received the 2nd dose of the vaccine due to personal reasons and inquired if she should get the second dose or start over the series.  No additional medical history or medications information were provided. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I've got a milder case of shingles right now; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chemotherapy (I had chemo 3 years ago.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I've got a milder case of shingles right now). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date : 09-MAY-2025 This case was reported by a patient via interactive digital media Reporter reported that he/she got a milder case of shingles right now.  He/she had small blisters from his/her wrist to his/her arm pit.  He/she also had both shingles vaccines and he/she had chemo 3 years ago. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient that went beyond 6 months for the second dose of Shingrix; This non-serious case was reported by a consumer via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: a patient that went beyond 6 months for the second dose of Shingrix). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 07-MAY-2025 The reporter (office staff) reported that the physician had a patient that went beyond 6 months for the second dose of Shingrix.  He wanted a medial inquiry to answer if the patient needed to re-start the 2-dose series over or if the patient could just get the second dose even though it was past 6 months. Till the time of reporting the patient did not receive the second dose of Shingrix, which led to an incomplete course of vaccination.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; still gets the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In APR-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still gets the shingles). The patient was treated with lidocaine. The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAY-2025 This case was reported by a wife of the patient via interactive digital media. Reporter reported that her husband (patient) had the vaccine and booster and still got the shingles.  He just got it 5 weeks ago (from the date of reporting) they were finally not hurting him anymore.  His physician gave him a prescription immediately and they gently put lidocaine on the rash to help numb the pain. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding  time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st dose)and Shingles vaccine(2nd dose).
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: am I too late to get the second dose now that it's May, 2025; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient had first Shingrix shot in September of 2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: am I too late to get the second dose now that it's May, 2025). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 09-MAY-2025 Patient stated that they had first Shingrix shot in September of 2024; and asked whether its too late to get the second dose as it was May, 2025. Till the time of reporting patient did not receive second dose of vaccination which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site swelling, Pyrexia, Vaccine positive rechallenge
Clinical narrative: swelling around the injection siteand mad a motion of about a 6 circle on her arm; fever; fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (received first dose on an unknown date for tolerance of first dose refer case US2025AMR059471).   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 injection site swelling (Verbatim: swelling around the injection siteand mad a motion of about a 6 circle on her arm), fever (Verbatim: fever) and fatigue (Verbatim: fatigue). Rechallenge with Shingrix was positive. The outcome of the injection site swelling was not reported and the outcome of the fever and fatigue were resolved (duration 1 day).   It was unknown if the reporter considered the injection site swelling, fever and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site swelling, fever and fatigue to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR059471   Additional Information: GSK Receipt Date: 09-MAY-2025 The patient of approximately 55 age took the 2 dose series of Shingrix vaccine. The reporter stated that after each dose the patient experienced swelling around the injections site and mad a motion of about a 6 inch circle on her arm. She also experienced fever, fatigue that lasted about a day each time.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pyrexia, Vaccine positive rechallenge
Clinical narrative: patient experienced injection site pain; fever; felt like crap; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date (refer case US2025AMR059456)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: patient experienced injection site pain), fever (Verbatim: fever) and feeling abnormal (Verbatim: felt like crap). Rechallenge with Shingrix was positive. The outcome of the injection site pain, fever and feeling abnormal were resolved (duration 36 hrs).   It was unknown if the reporter considered the injection site pain, fever and feeling abnormal to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever and feeling abnormal to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR059456   Additional Information: GSK Receipt Date: 08-MAY-2025 Patient was approximately 60 years old. Patient had been vaccinated with Shingrix and a few hours after the injections the patient experienced injection site pain, within a few hours experienced fever and felt like crap. The symptoms lasted about 36 hours and patient is fully recovered.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose to an adult patient; Pediatric dose to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 47-year-old female patient who received HBV (Engerix B pediatric) (batch number 4D333) for prophylaxis.   On 09-MAY-2025, the patient received Engerix B pediatric. On 09-MAY-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose to an adult patient) and underdose (Verbatim: Pediatric dose to an adult patient). The outcome of the adult use of a child product and underdose were not applicable.   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-2025 On 09-May-2025, a call was received and mentioned that one of their clients administered an Engerix-B pediatric dose to an adult patient which led to adult use of a child product and underdose. They had a new employee, adult employee, and they need the Hep B vaccine (Engerix-B), but the ped-adolescent one was given, so they are wondering what were the next steps that needs to be done, like if they can give another one will it equal out to the adult. The Vaccine Administration Facility is the same as Primary Reporter. The vaccine was administered on 09th May 2025.
Sex: F
Vaccine: HEPAB
Symptoms: Exposure during pregnancy
Clinical narrative: Probable Twinrix administration to a pregnant woman; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced vaccine exposure during pregnancy (Verbatim: Probable Twinrix administration to a pregnant woman). The outcome of the vaccine exposure during pregnancy was not applicable.   Pregnancy exposure: Pregnancy Exposure (Twinrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   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-2025 A Health Care Professional reported claiming to be a "physician who wants to speak with a Doctor of Medicine and know his license number and qualifications", mentioning that he had previously had a call that had not gone well.  The agent was asked him if he had a case number, which he denied.  The agent subsequently asked if he wanted to ask his question and then try to connect him with a Doctor of Medicine, but the Health Care Professional asked how he did not know his question since he had already called, although he mentioned that it was about "Twinrix in the context of pregnancy" to which the agent explained that without a case number could not be aware of it, but having already mentioned his question in a general way, he could try to connect him to a Doctor of Medicine, however, before the agent could finish this phrase, the Health Care Professional asked in a rude tone if the agent would help him or instead continue giving him "rubbish" to which the agent explained that of course will help, as long as both parties could communicate in a nice and polite manner, which finally led to him ending the call. No contact details or further information was than "Twinrix in the context of pregnancy" was given, which led to Vaccine exposure during pregnancy.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 12-MAY-2022 of batch number of DC434 and expiry date of 03 June 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not received a second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 12-MAY-2025 The pharmacist called today to report about a female patient who received a first dose of Shingrix on May 12, 2022 and has not received a second dose yet which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Immunodeficiency
Clinical narrative: Becomes immunocompromised following vaccination with Shingrix; This serious case was reported by a physician via call center representative and described the occurrence of immunocompromised in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced immunocompromised (Verbatim: Becomes immunocompromised following vaccination with Shingrix) (serious criteria GSK medically significant). The outcome of the immunocompromised was unknown.   It was unknown if the reporter considered the immunocompromised to be related to Shingrix.     The company considered the immunocompromised to be unrelated to Shingrix.   Additional Information: GSK Receipt Date : 12-MAY-2025 The physician inquired what was the recommendation if somebody did complete a Shingrix vaccine series but then at some point later became immunocompromised because of disease or therapy was there a recommendation to re-vaccinate for booster for immune compromised patients.; Sender's Comments: Immunodeficiency is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: If I administered a dose intramuscularly instead of subcutaneously; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: If I administered a dose intramuscularly instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   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 : 13-MAY-2025 Healthcare professional reported that if they administered a dose intramuscularly instead of subcutaneously which led to Subcutaneous injection formulation administered by other route. Anonymous Healthcare provider did not consent follow-up from Safety Department.  No vaccination date, vaccine detail or patient demographics were obtained in this call.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: patient had been administered Priorix intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: patient had been administered Priorix intramuscularly). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   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: 13-MAY-2025 The pharmacist reported that a patient had been administered Priorix intramuscularly, which led to subcutaneous injection formulation administered by other route
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: asked how to proceed with the second dose of Shingrix after a patient received the first dose one year and a half ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose one year and a half ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: asked how to proceed with the second dose of Shingrix after a patient received the first dose one year and a half ago). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 14-MAY-2025 The registered pharmacist asked how to proceed with the second dose of Shingrix after a patient received the first dose one year and a half ago. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still having shingles outbreak; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still having shingles outbreak). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date : 14-MAY-2025 An immunocompromised patient already received 2 dose series of Shingrix and because of immunocompromised still had shingles outbreak. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Longer than recommended interval; This non-serious case was reported by a consumer via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Longer than recommended interval). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 14-MAY-2025 The reporter reported that if a patient received their first Shingrix dose, but three years has lapsed and they did not receive their second dose do they have to start the series over. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: Long COVID; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (Long COVID) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (Long COVID). At the time of the report, POST-ACUTE COVID-19 SYNDROME (Long COVID) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication was not provided. It was reported that the caller knows a woman who developed long covid following vaccination which reporter described as a form of AIDS. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-786451 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786451:Master case (Reporter case)