chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: shots so painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain (Verbatim: shots so painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2025 This case was reported by a patient via interactive digital media.  Patient reported that he/she found those shots so painful, but was glad got protected from shingles, too. The follow-up could not be possible as no contact details were available.
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspected Vaccination failure; still got shingles /but it was very mild, just a little itchiness; after my 1st bout of covid; 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.   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), shingles (Verbatim: still got shingles /but it was very mild, just a little itchiness) and covid-19 (Verbatim: after my 1st bout of covid). The outcome of the vaccination failure, shingles and covid-19 were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 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 and covid-19 to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2025 This case was reported by a patient via interactive digital media. The patient had two shingles shot and still got shingles, it was after 1st bout of covid.  The patient reported shingles was very mild with just a little itchiness. 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.; 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 Shingles vaccine dose 1 and Shingles vaccine dose 2.
Age: 18.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient had a non-reactive Hepatitis B surface antigen, non-reactive Hepatitis B surface antibody, and non-reactive Hepatitis B the total antibody; recive 2nd dose of Engerix B on 08-JAN-2013 and 3rd dose recive on 01-OCT-2013; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 19-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   The patient's past medical history included herpes simplex, hiv infection and hypertriglyceridemia. Concurrent medical conditions included tobacco abuse.   On 01-OCT-2013, the patient received the 3rd dose of Engerix B. On 08-JAN-2013, the patient received the 2nd dose of Engerix B. On 04-DEC-2012, the patient received the 1st dose of Engerix B. On 01-OCT-2013, an unknown time after receiving Engerix B, not applicable after receiving Engerix B and Engerix B and not applicable after receiving Engerix B and Engerix B, the patient experienced drug dose administration interval too long (Verbatim: recive 2nd dose of Engerix B on 08-JAN-2013 and 3rd dose recive on 01-OCT-2013). On 08-MAY-2024, the patient experienced therapy non-responder (Verbatim: patient had a non-reactive Hepatitis B surface antigen, non-reactive Hepatitis B surface antibody, and non-reactive Hepatitis B the total antibody). The outcome of the therapy non-responder was not reported and the outcome of the drug dose administration interval too long 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: 24-SEP-2024 The reporter reported that the patient had received four dose doses of Engerix b. The reporter mentioned that the 4th dose of Hep B vaccine was administered at clinic. The reporter reported that this patient had a non-reactive Hepatitis B surface antigen, non-reactive Hepatitis B surface antibody, and non-reactive Hepatitis B the total antibody on 08th May 2024, which led to therapy non responder. The patient received 3rd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Laboratory test normal, Vaccination failure, Zoster sine herpete
Clinical narrative: Suspected vaccination failure; suspected zoster sine herpete (ZSH); flank pain/ the patient had this severe pain; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included diabetes (female patient with diabetes).   In FEB-2025, 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), zoster sine herpete (Verbatim: suspected zoster sine herpete (ZSH)) and flank pain (Verbatim: flank pain/ the patient had this severe pain). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete and flank pain were unknown.   It was unknown if the reporter considered the vaccination failure, zoster sine herpete and flank pain to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the zoster sine herpete and flank pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2025 The reporter called to speak with someone regarding Shingrix and zoster sine herpete (ZSH) and was asking whether there was an increased reaction of zoster sine herpete (ZSH) in patient who were vaccinated (not acutely/recently) with Shingrix.  The reporter stated two weeks ago a female patient with diabetes probably 50ish in age who was vaccinated with a shingles vaccine (unknown if it was Shingrix) presented with flank pain as an initial complaint. She had no proof of zoster sine herpete (ZSH), just a clinical suspicion because all the workup was negative but the patient had this severe pain that she could not account for. Now, in retrospect she thought it was zoster sine herpete (ZSH). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for zoster sine herpete (shingles) and laboratory confirmation regarding zoster sine herpete (shingles) were unknown at the time of reporting. This case was one of the three case reported by the same reporter for different patients.; 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 Shingles vaccine. US-GSK-US2025026210:2 of 3 patient US-GSK-US2025026208:Same reporter/Different patient
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: they are now giving it to many adults; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in unspecified number of patients who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: they are now giving it to many adults). The outcome of the inappropriate age at vaccine administration 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 : 05-MAR-2025 This case is for unspecified number of adult patients. A pharmacist contacted us via chat and mentioned that the Priorix insert said subcutaneous, but referred to children only.  As they were giving it to many adults, many regulatory bodies were saying intramuscular or subcutaneous, which led to Inappropriate age at vaccine administration.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; This spontaneous report received from a health care professional concerned an 82 year old female patient. The patient's height and weight were not reported. Age at time of vaccination 9  old.  The patient's concurrent conditions included: carpal tunnel, pain on toes, diabetes, heart condition, and pain on chest.  Initial information was processed with additional information received on 11-Feb-2025.   The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. Dose number in series 2. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced died. (Dose number in series 2). It was reported that the patient got 2 Covid shots and she died after a month of getting the shots. The action taken with janssen covid-19 vaccine was not applicable.  It was unknown if an autopsy was performed.  Reported cause of death was unknown cause of death.  The patient died of died on an unspecified date.  This report was associated with a product quality complaint: Product Complaint 90000353966.  Investigation Results: 90000353966 - (Void:Y). This record reports patient death with no allegation of a product quality issue. This report of patient death was not referred by Safety partners for investigation. No quality investigation is required at this time. Approval to void due to no PQC identified.  This report was serious (death).; Sender's Comments: V0-Death. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: Unknown cause of death
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: the lymph nodes under the receiving arm (left) were killing her. Pain lasted for 2 days.; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 72-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Feb2025 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 24Feb2025, outcome "recovered" (27Feb2025), described as "the lymph nodes under the receiving arm (left) were killing her. Pain lasted for 2 days.". Therapeutic measures were not taken as a result of lymph node pain.  Additional information: Patient reports that the day after receiving her covid booster, the lymph nodes under the receiving arm (left) were killing her. Pain lasted for 2 days.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series complete), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". Patient got covid and wasn't nearly as sick as husband. She did not break out.
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: severe eczema flare ups all over my neck face back and arms; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 as dose 1 (toppac); single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Kiwi Allergy" (unspecified if ongoing); "eczema" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as dose number unknown, single. Past drug history included: Methylisothiazolinone, reaction(s): "Allergy". Vaccination history included: Covid-19 (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization; Covid-19 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: ECZEMA (non-serious) with onset 2023, outcome "not recovered", described as "severe eczema flare ups all over my neck face back and arms". Therapeutic measures were taken as a result of eczema (Topical steroids).  Additional information: Since a few weeks after the Covid booster (my 5th booster) I have had severe eczema flare ups all over my neck face back and arms. This has gone on for 1.5 years now and I can't seem to calm my immune system down.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Delayed reaction to pneumococcal - developed erythematous injection site reaction on 12/25/24, then redness spread to full circumference of arm (itchy, red), resolved after 4 days
Vaccine: MMR, MMR, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; Customer called and reported that an additional dose of MMR-II was administered to a 5-year-old consumer after the series was completed. The final dose of the series was administered on 2/15/2024. The additional dose was administered on 2/13/2025; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender.    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 was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, lot #, and expiration date were not reported) for prophylaxis, diluted in sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). On 15-Feb-2024, the patient received the final dose of the series of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), dose number 2, (lot # and expiration date were not reported), diluted in sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). On 13-Feb-2025 (after the series were completed), the patient received a third dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II),, dose number 3, (lot # and expiration date were not reported) diluted in sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported) (Extra dose administered). No additional adverse event was reported.
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; expired dose of GARDASIL 9 was administered.; This spontaneous report was received from a medical assistant concerning to a patient of unspecified age and gender.   The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.   On 25-FEB-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) pre-filled syringe, lot #W031448, expiration date: 12-FEB-2025, 0.5 mL administered by intramuscular route (IM) as prophylaxis (expired product administered.)  No additional adverse events were reported (no adverse event.)
Age: 8.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported; multiple patients may have received improperly stored PROQUAD since it "was stored in the refrigerator for months"  instead of the freezer; This spontaneous report has been received from a nurse regarding an 8-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Polio vaccine inact 3v (Vero) (IPOL), Hepatitis b vaccine rHBsAg (yeast) (ENGERIX-B), and Diphtheria vaccine toxoid (+) Pertussis vaccine acellular 3-component (+) Tetanus vaccine toxoid (BOOSTRIX).  On 29-JAN-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Solution for injection, administered subcutaneously in the left arm as the first dose with sterile diluent (BAXTER STERILE DILUENT), for prophylaxis (lot number reported as Y013579, which has been verified as valid, expiration date not reported but validated as 03-FEB-2026).  It was reported that when another vaccine's shipment arrived, there was no room in the freezer to accommodate it. It was assumed that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) could be refrigerated, therefore, they were moved to refrigerators where they remained between 36 to 36 degrees Fahrenheit from 13-NOV-2024 until administration (Product storage error). No adverse events were reported.  This is one of several reports from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :  , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 07/31/2016 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 0.92
Vaccine: MMR, VARCEL, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: innapropriate age of vaccine administered; HCP states she could not confirm if there were any symptomatic events that occurred; This spontaneous report has been received from a health care proffesional regarding a 11-months-old patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On an unspecified date (reported as one day before their first birthday), the patient was vaccinated with   Varicella Virus Vaccine Live (Oka-Merck) lyophilisate and solvent for solution for injection (VARIVAX) for prophylaxis, 0.5 milliliters and  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live lyophilisate and solvent for solution for injection (MMR-II) for prophylaxis, 0.5 milliliters concomitantly (strengths, lot numbers, expiration dates, anatomical locations, schemes and routes of administration not provided). (innapropriate age of vaccine administered).  The health care professional could not confirm if any symptomatic events occurred (no adverse event).
Sex: M
Vaccine: MMRV, UNK
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a nurse referring to a 6-year-old male patient. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided.  On 23-Jan-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for prophylaxis, lot number Y017208, which has been verified to be valid, expiration date reported and validated as 13-Apr-2026, second dose, subcutaneously, in left thigh. (strength not provided)  The administered dose of the vaccine was stored at multiple temperatures with a range  from 15 degree Fahrenheit to 46 degree Fahrenheit during an 432 (unit not provided).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 08/05/2018 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Vaccine: MMRV, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/; Patient received a dose of PROQUAD in September and another dose in February. No reported signs or symptoms of adverse effects. Permission to contact HCP was given. No additional AE/no PQC; Patient received a dose of PROQUAD in September and another dose in February. No reported signs or symptoms of adverse effects. Permission to contact HCP was given. No additional AE/no PQC; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date in September 2024, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot#: y009348, expiration date: 11-NOV-2025; strength, dose, and route of administration were not reported) for prophylaxis. On 25-FEB-2025, the patient was vaccinated with the second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot#: y017205, expiration date: 13-APR-2026; strength, dose, and route of administration were not reported) for prophylaxis (inappropriate age at vaccine administration and inappropriate schedule of vaccine administered). . No reported signs or symptoms of adverse effects.
Age: 1.0
Sex: M
Vaccine: FLUX, HIBV, MMR, UNK, UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; products that experienced temperature excursion were administered to patient; This spontaneous report was received from a registered nurse and refers to a 12-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 10-DEC-2024, the patient was vaccinated with improperly stored doses of the following vaccines:  dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #, expiration date, exact dose route and site of administration was not reported) reconstituted with sterile diluent (lot # and expiration date were not reported);  first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (M-M-R II) lot # X011441 was confirmed to be valid, expiration date 19-APR-2025, subcutaneously at right thigh (exact dose was not reported) reconstituted with sterile diluent (lot # and expiration date were not reported);  first dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot # X025482 was confirmed to be valid, expiration date 12-APR-2025, intramuscularly at right thigh (exact dose was not reported) fourth dose of Pneumococcal vaccine conj 20v lot # reported as HN2630, expiration date reported as 31-AUG-2025, intramuscularly at left thigh (exact dose was not reported) second dose of influenza vaccine lot # reported as U8518DA, expiration date reported as 30-JUN-2025, intramuscularly at right thigh (exact dose was not reported) first doe of Haemophilus influenzae type b vaccine lot # reported as M94PZ, expiration date reported as 14-MAR-2026, intramuscularly at left thigh (exact dose was not reported) all vaccines administered for prophylaxis. The temperature excursion was a result of a reading from a digital data logger, however no details were provided. No additional adverse event was reported. Lot # is being requested and will be submitted if received.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, UNK, UNK, UNK, UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; products that experienced temperature excursion were administered to patient; This spontaneous report was received from a registered nurse and refers to a 12-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 08-JAN-2025 (conflicting information: also reported as 08-JAN-2024), the patient was vaccinated with improperly stored doses of the following vaccines:  first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #, expiration date, exact dose route and site of administration was not reported) reconstituted with sterile diluent (lot # and expiration date were not reported);  first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (M-M-R II) lot # X011441 was confirmed to be valid, expiration date 19-APR-2025, subcutaneously at right thigh (exact dose was not reported) reconstituted with sterile diluent (lot # and expiration date were not reported);  first dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot # X025482 was confirmed to be valid, expiration date 12-APR-2025, intramuscularly at right thigh (exact dose was not reported) fourth dose of Pneumococcal vaccine conj 20v lot # reported as HN2630, expiration date reported as 30-AUG-2025, intramuscularly at right thigh (exact dose was not reported) first doe of Haemophilus influenzae type b vaccine lot # reported as M94PZ, expiration date reported as 14-JUN-2026, intramuscularly at left thigh (exact dose was not reported) all vaccines administered for prophylaxis. The temperature excursion was a result of a reading from a digital data logger, however no details were provided. No additional adverse event was reported. Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: MMR, MMR, VARCEL, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: arm was improved but looked a little bruised; her son began complaining of pain if his left upper arm and did not want his mother to touch the area; she noticed there was a  reddened area; This spontaneous report was received from a consumer or other non health professional and refers to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.     On 28-Feb-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), in the right arm right arm . On the same date, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), in the left arm (lot # and expiration date were not reported). Both vaccines were administered for prophylaxis (doe, scheme, strength, route of administration, expiration date, and lot number were not reported). Both vaccines were reconstituted with sterile diluent (BAXTER STERILE DILUENT), (indication, expiration date, and lot # were not reported).   On the evening of 06-MAR-2025 her son began complaining of pain if his left upper arm and did not want his mother to touch the area and she noticed there was a reddened area like a "giant rosette" in the middle with an extra red ring around the edges that measured about the size of a silver dollar in which she gave her son Tylenol for the pain and he went to bed (vaccination site pain) (vaccination site erythema). On the morning of 07-MAR-2025 the caller stated her son's arm was improved but looked a little bruised and he seemed "fine and did not complain of pain" (vaccination site bruised). At the reporting time, the outcome of the events was unknown.   The causal relationship between the events and the suspect vaccines was not provided.
Sex: M
Vaccine: MMR, MMR, VARCEL, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site bruising, Vaccination site pain
Clinical narrative: arm was improved but looked a little bruised; her son began complaining of pain if his left upper arm and did not want his mother to touch the area; she noticed there was a  reddened area; This spontaneous report was received from a consumer or other non health professional and refers to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.     On 28-Feb-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), in the right arm right arm . On the same date, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), in the left arm (lot # and expiration date were not reported). Both vaccines were administered for prophylaxis (doe, scheme, strength, route of administration, expiration date, and lot number were not reported). Both vaccines were reconstituted with sterile diluent (BAXTER STERILE DILUENT), (indication, expiration date, and lot # were not reported).   On the evening of 06-MAR-2025 her son began complaining of pain if his left upper arm and did not want his mother to touch the area and she noticed there was a reddened area like a "giant rosette" in the middle with an extra red ring around the edges that measured about the size of a silver dollar in which she gave her son Tylenol for the pain and he went to bed (vaccination site pain) (vaccination site erythema). On the morning of 07-MAR-2025 the caller stated her son's arm was improved but looked a little bruised and he seemed "fine and did not complain of pain" (vaccination site bruised). At the reporting time, the outcome of the events was unknown.   The causal relationship between the events and the suspect vaccines was not provided.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Skin Rash at injection site; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number KB2YT) for prophylaxis.   On 04-DEC-2024, the patient received the 1st dose of Shingrix (left deltoid). On 04-DEC-2024, less than a day after receiving Shingrix, the patient experienced injection site rash (Verbatim: Skin Rash at injection site). On 11-DEC-2024, the outcome of the injection site rash was resolved (duration 7 days).   The reporter considered the injection site rash to be related to Shingrix.     The company considered the injection site rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-MAR-2025 The healthcare professional reported that the patient received the 1st dose of Shingrix and experienced skin rash at injection site. The patient was not on other products. This was not related to an existing case. The healthcare professional did not have consent to contact.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Gait disturbance, Hypoaesthesia, Paraesthesia
Clinical narrative: balance affected; walking affected; Sudden tingling in left foot and lower leg; Tingling and numbness in left foot; This non-serious case was reported by a consumer and described the occurrence of tingling of extremity in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high. Concomitant products included lisinopril.   On 06-SEP-2024, the patient received Shingrix. On 07-SEP-2024, 1 days after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: Sudden tingling in left foot and lower leg) and numbness in feet (Verbatim: Tingling and numbness in left foot). On an unknown date, the patient experienced balance difficulty (Verbatim: balance affected) and walking difficulty (Verbatim: walking affected). The outcome of the tingling of extremity and numbness in feet were not resolved and the outcome of the balance difficulty and walking difficulty were not reported.   It was unknown if the reporter considered the tingling of extremity, numbness in feet, balance difficulty and walking difficulty to be related to Shingrix.     It was unknown if the company considered the tingling of extremity, numbness in feet, balance difficulty and walking difficulty to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAR-2025. The patient after taking the Shingrix vaccine and he experienced sudden tingling and numbness in left foot and lower leg. The reporter wanted to know what could do about this or it had not gone away.  Patient's walking was affected and balance was affected.  Pharmacist said to the patient the Shingrix vaccine could cause this and she read this on line as well.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This non-serious case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-JAN-2025, the patient received the 1st dose of Shingrix. On 09-JAN-2025, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms). The outcome of the influenza-like symptoms was resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix.     The company considered the influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-MAR-2025 The patient experienced flu like symptoms, joint pain and headache after the first dose of Shingrix.
Vaccine: DTAPHEPBIP
Symptoms: Neutropenia
Clinical narrative: my child was diagnosed with neutropenia 66 days after Pediarix3 (Hep b 4); This serious case was reported by a consumer via interactive digital media and described the occurrence of neutropenia in a child patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Pediarix. On an unknown date, 66 days after receiving Pediarix, the patient experienced neutropenia (Verbatim: my child was diagnosed with neutropenia 66 days after Pediarix3 (Hep b 4)) (serious criteria GSK medically significant and other: Serious as per reporter). The outcome of the neutropenia was unknown.   The reporter considered the neutropenia to be related to Pediarix and Pediarix Pre-Filled Syringe Device.     The company considered the neutropenia to be unrelated to Pediarix and Pediarix 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: 04-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that his/her child was diagnosed with neutropenia 66 days after Pediarix. The reporter mentioned that the burden of proof was to show product did not cause , had neutropenia.; Sender's Comments: Neutropenia is an unlisted event which is considered unrelated to GSK vaccine Pediarix and Pediarix PRE-FILLED SYRINGE DEVICE.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: arm hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm hurt). The outcome of the pain in arm was resolved (duration 1 week).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2025 This case was reported by a patient via interactive digital media. The patient took the first vaccine and arm hurt for a week. He/she passed on the second one. He/she already had shingles and stated would rather risk getting them again than getting that second shot.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: did not hurt as much as the pharmacist said it would; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: did not hurt as much as the pharmacist said it would). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2025 This case was reported by a patient via interactive digital media. The patient just got first shot of shingles vaccine and it did not hurt as much as the pharmacist said it would.  The patient will go back in about 3 months or so for second dose.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: flu symptoms for two days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had the shingles last summer, it last about 30 day) and pain.   In MAR-2025, the patient received Shingrix. In MAR-2025, an unknown time after receiving Shingrix, the patient experienced flu symptoms (Verbatim: flu symptoms for two days). The outcome of the flu symptoms was not resolved.   The reporter considered the flu symptoms to be related to Shingrix.     The company considered the flu symptoms to be related to Shingrix.   Additional Information: GSK receipt date: 07-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the shingles last summer, it was last about 30 days, very painful, trying to sleep at night was uncomfortable. The patient reporter that he just got the first shot four days ago (Day before reporting) and had flu symptoms for two days but it beats the shingles by far.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix was given IM instead of SQ; 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: Priorix was given IM instead of SQ). 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: 05-MAR-2025  The reporter reported that they had an incident where Priorix was given intramuscular instead of subcutaneous which led to subcutaneous injection formulation administered by other route.  The reporter asked do they need to re-vaccinate.
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose given; Pediatric dose given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   Previously administered products included Engerix b (received 1st dose of Engerix b in an unknown date).   On an unknown date, the patient received the 2nd dose of Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose given) and adult use of a child product (Verbatim: Pediatric dose given). The outcome of the underdose and adult use of a child product 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: 05-MAR-2025 The pharmacist that an adult patient received their second Engerix-B dose as a Pediatric dose which led to underdose and  adult use of a child product.  They had no information about the event, dose or patient,  The Vaccine Administration Facility is the same as Primary Reporter.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Extra dose administered
Clinical narrative: accidental administartion of Two Boostrix doses given at one instance; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 53-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number XN575, expiry date 22-MAR-2027) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number XN575, expiry date 22-MAR-2027) for prophylaxis.   On 05-MAR-2025, the patient received the 2nd dose of Boostrix and the 1st dose of Boostrix. On 05-MAR-2025, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced accidental overdose (Verbatim: accidental administartion of Two Boostrix doses given at one instance). The outcome of the accidental overdose 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: 05-MAR-2025 The pharmacist called in to request data about the recommendations following the accidental administration of 2 doses of Boostrix at one which led to Accidental overdose and asked if Shingrix can be given in such scenario. The vaccine administration facility was the same as primary reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death
Age: 1.25
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: fever, red,  painful, raised area on the right thigh Proximal. Patient was placed on cephalexin for skin infection and is to return in 2 weeks for recheck of area
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC20
Symptoms: Expired product administered
Clinical narrative: The ActHIB expired on 2-28-25.  this was an expired vaccine that was given to patient
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Epilepsy
Clinical narrative: Patient had a status epileptucs seizure lasting 25 minutes and requiring use of seizure medication
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Infant irritability, Injection site pain, Product administered at inappropriate site
Clinical narrative: Patients mother also sent in a photo that showed the injection sites were not appropriately spaced. This resulted in increased fussiness and tenderness to the area in patient.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Epistaxis, Pain in extremity, Pyrexia, Rash
Clinical narrative: Rash from head to toe. Bloody nose. Fever. Arm soreness.
Age: 7.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse reactions
Age: 5.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Dysphagia, Injection site reaction, Paraesthesia oral, Pharyngeal swelling, Urticaria
Clinical narrative: MMR and Varicella were administered separately due to history of epilepsy. However, about 10 minutes after vaccines were given, he developed a welt on the L leg where varicella and flu were administered. Benadryl was ordered but before it could be given, he started complaining of throat swelling, lips tingling and inability to swallow. Epi pen dose ordered, verified and administered. Patient walked down to ED.
Age: 34.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Patient noted swelling under left arm pit around 9:00 am on 3/11/25. Stated it is tender and bulging. No other symptoms noted per patient.
Age: 56.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Erythema, Induration, Peripheral swelling, Pyrexia
Clinical narrative: Swelling in left arm, redness, fever, and knot formed about 2 hours after vaccine
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Ultrasound kidney normal, Vomiting
Clinical narrative: Vomiting and diarrhea the day after immunizations.  Needed to go to ED.  Unclear if it is vaccine related or a GI bug.  Parents requesting VAERS completed.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Headache, Pyrexia
Clinical narrative: Bruising within 12 hours fever chills and headache within 24 hours
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Induration
Clinical narrative: INJECTION SITE-UPPER LEFT ARM. SMALL KNOT FORMED AT BASE OF INNER LEFT WRIST (3 OUT OF 10 PAIN) CLOSE TO BOTTOM OF PALM. NOTICED ON 03/08/25.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Vaccine was given on 3/11/2025 but it expired on 3/3/2025.  Does child need to be re vaccinated?
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: End stage renal disease, Immune system disorder
Clinical narrative: My dad and I both received the Janssen vaccine for our first COVID shot and later got the Pfizer vaccine on January 5, 2022. My dad has type 2 diabetes. After the vaccination, he began experiencing joint pain. Later, when he returned to country and underwent a physical checkup, he was diagnosed with an immune system disease that was causing all his symptoms. He is still receiving treatment for it now. In January 2025, I was diagnosed with stage 5 kidney failure, also due to an immune system disorder attacking my own body. I was perfectly healthy last year, and there?s no history of these issues in my family. My grandparents and their siblings all lived past 90. I suspect the vaccine may have altered my immune system response.