chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 11 (8 months) year old patient received Spikevax rather than pediatric Moderna.  Mom reports no additonal side effects and patient feels fine.  She was not concerned.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric dose of Covid vaccine given to adult.  No treatment.  Not adverse outcome known.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric Covid vaccine given to adult.  No treatment.  No adverse effect known.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient presented to clinic requesting covid vaccination.  Vaccine  was given and when going to put the dose in system the state vaccine website it was found that patient had received same vaccine on 9/27/2024
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Provider called the pharmacy this morning to report patient died this morning.
Age: 13.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient was administered Meningococcal B , which was not due, rather than  MenACWY which was due to be given.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Given at pharmacy, Pfizer vaccine, information not available
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse  event(s), treatment, and outcome(s): (symptoms, signs, time course, etc.) Patient was administered the same vaccine a week prior.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Immediate post-injection reaction
Clinical narrative: Immediately after injection,  entire shoulder began to burn. Burning sensation increased over the next hour with use.     To note: right shoulder has a rotator cuff tear and bicep head insertion tear for approximately two years.  Has been compensating with left shoulder
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient called in to office on 10/26 to report:  patient called in to report a small pin point, itchy rash on stomach, chest, back and upper neck this AM. Patient had Hep B vaccine on 10/25/24 in the office. patient states she took a Zyrtec at 0830.   patient denies fever, swelling, difficulty breathing or any other symptoms at this time.  Patient denies rash or swelling at injection site.  Patient is with parents and denied appt today.  Patient will send in pictures through the portal for chart  Per Dr On Call : I have not seen any pictures, but ok to observe for now and continue the antihistamine.  If rash persists or worsens, then she should be seen. dad aware/Patient went to Urgent Care on 10/27/24.    Patient called in for office visit on 10/28/24 due to rash has not resolved and was seen by Dr.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient was administered Meningococcal B, which was not due, rather than MenACWY which was due to be given
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pt given covid 19 pfizer 6mth to <5  all 3 doses given and not reconstituted
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Disorientation, Fatigue, Nasal ulcer, Scab
Clinical narrative: Vaccine was administered on 10/19/24. On 10/20/24, patient felt disoriented and fatigued. By Monday (10/21/24) blisters started appearing on face, eyes, and nose. The inside of her nose was raw then scabbed over. Sores around the tip of her nose moved up into her nose. Her face and eyes developed scab. The following Monday (10/28/24) patient is just now recovering from scabbing that stayed in the facial area.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Skin erosion
Clinical narrative: Vaccine was administered on 10/19/24. On 10/20/24, patient felt disoriented and fatigued. By Monday (10/21/24) blisters started appearing on face, eyes, and nose. The inside of her nose was raw then scabbed over. Sores around the tip of her nose moved up into her nose. Her face and eyes developed scab. The following Monday (10/28/24) patient is just now recovering from scabbing that stayed in the facial area.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: The patient experienced a 2in x 2in raised redness that was warm on her left deltoid, when the PREVNAR 20 was administered, itchy 24 hours post injection. She tool 25mg of diphenhydramine by mouth and it helped with the itch. Within 2 days, the raised area went away. However, on October 26th, the redness came back, this time measured 3in x 3in. She apply cortisone, with helped with the itch. The area still hurt, but less defined and less hot (warm).
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Product administered to patient of inappropriate age
Clinical narrative: Patient received and adult COMIRNATY dose in error instead of pediatric Pfizer dose at offsite clinic, was not done in pharmacy. Family was contacted and informed of error and reported child had experienced no ill effects to this point. Mother mentioned an upset stomach but she did not think it was related.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Swollen upper lip two days after the injection.  Relieve with Claritin
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Unable to lift right arm, Pain in arm
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness
Clinical narrative: Woke up dizzy without vertigo. Worse on first day, subsided over about 3 days.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Loss of appetite, chills, fever, exhaustion
Age: 0.5
Sex: M
Vaccine: COVID19, DTPPVHBHPB, FLU3, PNC20, RV5
Symptoms: Product preparation issue
Clinical narrative: Pt given covid 19 pfizer 6mth to <5  all 3 doses given and not reconstituted
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child underage.  No known reaction.
Age: 72.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Injection site swelling
Clinical narrative: Patient has persistent swelling in left deltoid
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Nurse reported an AE for PROQUAD and VARIVAX. The caller said a 1 year old patient received PROQUAD and VARIVAX on 10/21/2024. Confirmed no other AE occurred. AE letter sent to nurse. No other AE. No PQC.; This spontaneous report was received from a nurse refers to a 1-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 21-OCT-2024, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: injection, lot # X027626, expiration date: 28-MAY-2025 (exact dose, route of administration and anatomical location were not provided); and with one dose of varicella virus vaccine live (oka/merck)(VARIVAX), formulation: injection, lot # X023323, expiration date: 20-SEP-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (overdose). No additional adverse event (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse calling to report inadvertently administering PROQUAD vaccine after experiencing a temperature excursion.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 20-SEP-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, administered for prophylaxis (lot #X022919, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 12-MAR-2025; strength, dose and route of administration were not provided). It was reported that the vaccine underwent a temperature excursion which was -7.6 degrees Celsius (C) for 1 hour 36 minutes 0 seconds (product storage error). No previous temperature excursion was reported. There was no additional adverse event (AE) or product quality complaint (PQC) and no further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills; This non-serious case was reported by a consumer and described the occurrence of chills in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-OCT-2024, the patient received Shingrix. On 08-OCT-2024, 1 days after receiving Shingrix, the patient experienced chills (Verbatim: Chills). The outcome of the chills was resolving.   It was unknown if the reporter considered the chills to be related to Shingrix.     It was unknown if the company considered the chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-OCT-2024 The patient experienced Chills after Shingrix vaccine. The symptoms were not treated.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got 2 shots and got the worst shingles horrible/ Suspected vaccination failure; Got 2 shots and got the worst shingles horrible; 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: Got 2 shots and got the worst shingles horrible/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got 2 shots and got the worst shingles horrible). 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: 20-OCT-2024 This case was reported by a patient via interactive digital media. The patient got 2 shots and got the worst shingles horrible. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; 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 Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Developed a serious case of shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax on 12th February 2008).   On 24-MAR-2019, the patient received the 2nd dose of Shingrix. On 26-SEP-2018, the patient received the 1st dose of Shingrix. On 13-AUG-2024, 1969 days after receiving Shingrix and 2148 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Developed a serious case of shingles) (serious criteria other: Serious as per reporter). 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 Shingrix and Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 23-OCT-2024 The physician reported that a patient received Shingrix vaccine and developed a serious case of shingles. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of 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  laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.  Herpes zoster  is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received havrix at 1 year on 9/29/23, received 2nd havrix at 3/22/24.; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 17-month-old patient who received HAV (Havrix) for prophylaxis.   On 22-MAR-2024, the patient received the 2nd dose of Havrix. On 22-MAR-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: received havrix at 1 year on 9/29/23, received 2nd havrix at 3/22/24.). The outcome of the drug dose administration interval too short 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: 30-SEP-2024 The patient received 2nd dose of Havrix early than recommended which led to shortening of vaccination schedule. Medical Information has provided all information as available from nurse practitioner via the submitted form.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: gave an adult dose of Hepatitis A to a 2-year-old; I gave an adult dose of Hepatitis A to a 2-year-old; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 2-year-old female patient who received HAV (Havrix adult) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis.   On 30-SEP-2024, the patient received Havrix adult. On 30-SEP-2024, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: gave an adult dose of Hepatitis A to a 2-year-old) and overdose (Verbatim: I gave an adult dose of Hepatitis A to a 2-year-old). The outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-SEP-2024 The nurse reported that he/she gave an adult dose of Hepatitis A (Havrix adult) to an patient of inappropriate age, which led to adult product administered to child and overdose This had been administered that same day. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 year old patient, that got Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On 30-SEP-2024, the patient received Kinrix. On 30-SEP-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 11 year old patient, that got Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-SEP-2024 The other healthcare professional had a patient, and 11 year old patient, that got Kinrix, but they also received Adacel, which was Sanofi, so they got like double. The reporter just called to find out if there was any side effect from that, anything major that the patient should be looking out for. The Vaccine Administration Facility is the same as Primary Reporter. The patient got Kinrix vaccine at unapproved age which led to inappropriate age at vaccine administration. GSK Receipt Date: 30-SEP-2024 The other healthcare professional had a patient, and 11 year old patient, that got Kinrix, but they also received Adacel, which was Sanofi, so they got like double. The reporter just called to find out if there was any side effect from that, anything major that the patient should be looking out for. The Vaccine Administration Facility is the same as Primary Reporter. The patient got Kinrix vaccine at unapproved age which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: a patient was administered a dose of Shingrix that had been reconstituted with the adjuvant of Arexvy.; patient was administered a dose of Shingrix that had been reconstituted with the adjuvant of Arexvy; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 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 wrong solution used in drug reconstitution (Verbatim: a patient was administered a dose of Shingrix that had been reconstituted with the adjuvant of Arexvy.) and inappropriate dose of vaccine administered (Verbatim: patient was administered a dose of Shingrix that had been reconstituted with the adjuvant of Arexvy). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-OCT-2024 The pharmacy intern reported that a patient was administered a dose of Shingrix that had been reconstituted with the adjuvant of Arexvy, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This happened at a clinic and they did not knew who the patient was.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: nstead of Fluzone and Fluarix were administered.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 71-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis.   Co-suspect products included Fluconazole (Fluzone) for prophylaxis.   On 02-OCT-2024, the patient received Fluarix Quadrivalent 2023-2024 season and Fluzone. On 02-OCT-2024, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced wrong vaccine administered (Verbatim: nstead of Fluzone and Fluarix were administered.). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-OCT-2024 The nurse stated that a patient was supposed to receive Fluzone and the Covid vaccine on the day of reporting but instead Fluzone and Fluarix were administered which led to wrong vaccine administered. The nurse chose Fluarix 2023-2024 season for the suspect vaccine as Fluarix Trivalent 2024-2025 was not listed as an option.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: we had given a Kinrix to a child that is not within that 4-6 age range; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On 10-SEP-2024, the patient received Kinrix. On 10-SEP-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: we had given a Kinrix to a child that is not within that 4-6 age range). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-OCT-2024 A nurse called to inform that they had given a Kinrix to a child that was not within that 4 to 6 year age range. they had the same incident which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: a patient had AREXVY administered in OCTOBER 2023 and then another dose of AREXVY was administered in SEPTEMBER 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received Arexvy in October 2023).   In SEP-2024, the patient received the 2nd dose of Arexvy. In SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: a patient had AREXVY administered in OCTOBER 2023 and then another dose of AREXVY was administered in SEPTEMBER 2024). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2024 The pharmacist reported that the patient had Arexvy administered and then another dose of Arexvy was administered which led to extra dose administered. No further information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: Incomplete dose/patient only receiving about a 3rd of the dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Herpes zoster (Shingrix) (batch number T92HK, expiry date 10-AUG-2026) for prophylaxis.   On 07-OCT-2024, the patient received Shingrix. On 07-OCT-2024, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Incomplete dose/patient only receiving about a 3rd of the dose). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 07-OCT-2024 The pharmacist reported that earlier that day a Shingrix vaccine was given to a patient and the syringe leaked leading to the patient only receiving about a 3rd of the dose, which led to incomplete dose administered. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: temperature excursion for Priorix; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received MMR (Priorix) for prophylaxis.   On an unknown date, the patients received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: temperature excursion for Priorix). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-OCT-2024 The nurse practitioner reported that there was temperature excursion for some vaccines including Priorix and they did not knew if the Priorix vaccine was given or not to any patient, which led to incorrect storage of drug. The agent provided stability information and confirmed that the lyophilized part of Priorix was not stable anymore.
Age: 0.75
Sex: M
Vaccine: RV1
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: vaccine administration error with a 9 month old patient that received second dose of Rotarix (liquid) on October 8th 2024; 9 month old patient that received second dose of Rotarix (liquid); This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 9-month-old male patient who received Rota (Rotarix liquid formulation) (batch number 5F7L2, expiry date 08-MAY-2026) for prophylaxis.   Previously administered products included Rotarix (received 1st dose on 4th March 2024, batch number LN425, expiry date 13-OCT-2025).   On 08-OCT-2024, the patient received the 2nd dose of Rotarix liquid formulation. On 08-OCT-2024, an unknown time after receiving Rotarix liquid formulation, the patient experienced drug dose administration interval too long (Verbatim: vaccine administration error with a 9 month old patient that received second dose of Rotarix (liquid) on October 8th 2024) and inappropriate age at vaccine administration (Verbatim: 9 month old patient that received second dose of Rotarix (liquid)). The outcome of the drug dose administration interval too long and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-OCT-2024 The medical assistant reported that they had a vaccine administration error with a 9 month old patient that received 2nd dose of Rotarix (liquid) vaccine. The patient received second dose of Rotarix later than the recommended interval at an inappropriate age, which led to lengthening of vaccine schedule and inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got only 1 dose of vaccine 5 years 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 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: got only 1 dose of vaccine 5 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2024 The pharmacist asked that the patient need to restart now and take 2nd dose of vaccine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose not given in recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose Shingrix on 1st December 2021 of batch number E344C).   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: Second dose not given in recommended interval). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2024 A pharmacist reported about the administration of the second dose of Shingrix after the maximum recommended interval. The patient wants to receive the second dose. Till the time of reporting patient did not received the second dose of Shingrix which led to incomplete course of vaccination.
Age: 54.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Herpes zoster, Neck pain, Paraesthesia
Clinical narrative: Suspected vaccination failure; Shingles; she started having tingling; back pain; neck pain; shoulder pain; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Varicella zoster vaccine live (Oka/Merck) (Varivax) for prophylaxis.   In FEB-2021, the patient received the 2nd dose of Shingrix (unknown arm). In DEC-2020, the patient received the 1st dose of Shingrix (unknown arm). On 07-OCT-2024, the patient received Varivax. In OCT-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), tingling (Verbatim: she started having tingling), back pain (Verbatim: back pain), neck pain (Verbatim: neck pain) and shoulder pain (Verbatim: shoulder pain). The patient was treated with famciclovir. The outcome of the vaccination failure was not reported and the outcome of the shingles, tingling, back pain, neck pain and shoulder pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, tingling, back pain, neck pain and shoulder pain 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, tingling, back pain, neck pain and shoulder pain to be related to Shingrix and Shingrix.   Additional Information: GSK receipt Date: 22-OCT-2024 The patient received 2 doses of Shingrix in December 2020 and in February 2021 in local pharmacy and she also received Varivax vaccine in October 2024.  In October 2024, 2 to 3 days prior to the reporting day, she started having tingling and back pain and the back pain was becoming unbearable.  The patient had shoulder and neck pain as well.  The patient believed that she had shingles.  She inquired that it could come back as a back pain without a shingles rash. It was normal, what she was getting now after almost 16 days of the Varimax vaccine. The patient did not recall which arm she received both doses of Shingrix.  She was prescribed Famciclovir by her physician.  It was unknown if the reporter considered the shingles, tingling, back pain, neck pain and shoulder pain to be related to Varivax. This case was considered as suspected vaccination failure as details regarding 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 laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Age: 54.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; she started having tingling; back pain; neck pain; shoulder pain; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Varicella zoster vaccine live (Oka/Merck) (Varivax) for prophylaxis.   In FEB-2021, the patient received the 2nd dose of Shingrix (unknown arm). In DEC-2020, the patient received the 1st dose of Shingrix (unknown arm). On 07-OCT-2024, the patient received Varivax. In OCT-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), tingling (Verbatim: she started having tingling), back pain (Verbatim: back pain), neck pain (Verbatim: neck pain) and shoulder pain (Verbatim: shoulder pain). The patient was treated with famciclovir. The outcome of the vaccination failure was not reported and the outcome of the shingles, tingling, back pain, neck pain and shoulder pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, tingling, back pain, neck pain and shoulder pain 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, tingling, back pain, neck pain and shoulder pain to be related to Shingrix and Shingrix.   Additional Information: GSK receipt Date: 22-OCT-2024 The patient received 2 doses of Shingrix in December 2020 and in February 2021 in local pharmacy and she also received Varivax vaccine in October 2024.  In October 2024, 2 to 3 days prior to the reporting day, she started having tingling and back pain and the back pain was becoming unbearable.  The patient had shoulder and neck pain as well.  The patient believed that she had shingles.  She inquired that it could come back as a back pain without a shingles rash. It was normal, what she was getting now after almost 16 days of the Varimax vaccine. The patient did not recall which arm she received both doses of Shingrix.  She was prescribed Famciclovir by her physician.  It was unknown if the reporter considered the shingles, tingling, back pain, neck pain and shoulder pain to be related to Varivax. This case was considered as suspected vaccination failure as details regarding 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 laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure/currently has shingles; currently has shingles; Shingles rash; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had history of shingles prior to the vaccine ).   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/currently has shingles) (serious criteria GSK medically significant), shingles (Verbatim: currently has shingles) and rash (Verbatim: Shingles rash). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash 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 and rash to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 22-OCT-2024 The reporter was the patient who also stated that he was a physician. The patient stated that he received both Shingrix doses within the 2 to 6 month window in 2020. The patient currently had shingles in the V1 distribution right side. The patient asked more in depth questions and would like to spoke to medical information. 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  details regarding time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: I took a Covid test, which would be 9 days after the injection, and it tested positive/Nasal congestion/Runny nose/Sneezing/Low grade fever/Cough/Head cold/Nasopharyngitis/ Ache/Pain; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I took a Covid test, which would be 9 days after the injection, and it tested positive/Nasal congestion/Runny nose/Sneezing/Low grade fever/Cough/Head cold/Nasopharyngitis/ Ache/Pain) in a 76-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042914) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 Vaccine (Dose 1), Moderna Covid-19 Vaccine (Dose 2), Moderna Covid-19 Vaccine (Dose 6), Moderna Covid-19 Vaccine (Dose 4), Moderna Covid-19 Vaccine (Dose 5) and Moderna Covid-19 Vaccine (Dose 3). Past adverse reactions to the above products included No adverse effect with Moderna Covid-19 Vaccine, Moderna Covid-19 Vaccine, Moderna Covid-19 Vaccine, Moderna Covid-19 Vaccine, Moderna Covid-19 Vaccine and Moderna Covid-19 Vaccine.    On 05-Oct-2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 14-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced COVID-19 (I took a Covid test, which would be 9 days after the injection, and it tested positive/Nasal congestion/Runny nose/Sneezing/Low grade fever/Cough/Head cold/Nasopharyngitis/ Ache/Pain). At the time of the report, COVID-19 (I took a Covid test, which would be 9 days after the injection, and it tested positive/Nasal congestion/Runny nose/Sneezing/Low grade fever/Cough/Head cold/Nasopharyngitis/ Ache/Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2024, SARS-CoV-2 test: Positive. On an unknown date, Body temperature: Barely 99.         Concomitant medication was not provided. It was reported that on 12-Oct-2024, patient was unable to breathe through nose and felt very congested. On 13-Oct-2024, she started having cold like symptom of runny nose, coughing, sneezing and very low-grade fever of barely 99. On same day, she had cough in her throat and not in chest. Patient had the worst head cold and was a little achy. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Narcolepsy
Clinical narrative: have been diagnosed with narcolepsy accompanied by cataplexy; This spontaneous case was reported by a patient and describes the occurrence of NARCOLEPSY (have been diagnosed with narcolepsy accompanied by cataplexy) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NARCOLEPSY (have been diagnosed with narcolepsy accompanied by cataplexy) (seriousness criterion medically significant). At the time of the report, NARCOLEPSY (have been diagnosed with narcolepsy accompanied by cataplexy) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered NARCOLEPSY (have been diagnosed with narcolepsy accompanied by cataplexy) to be related.    No concomitant medication was reported.  It was reported that Patient had serious health condition that had developed after receiving three doses of your COVID-19 vaccine. Patient have been diagnosed with narcolepsy accompanied by cataplexy, which believed to have been caused by product. patient was deeply concerned about the misinformation surrounding the vaccine and the subsequent adverse effects it has had on health. Patient was ready to provide proof of diagnosis from both hospital and specialist.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2024: Live non-significant follow-up received with narrative and reference ID added; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chronic spontaneous urticaria
Clinical narrative: chronic spontaneous urticaria (hives); This spontaneous case was reported by a patient and describes the occurrence of CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria (hives)) in a 64-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1) in 2021 and COVID-19 vaccine (Dose 2) in 2022. Past adverse reactions to the above products included No adverse event with COVID-19 vaccine and Moderna COVID-19 vaccine.    On 20-Sep-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria (hives)) (seriousness criterion medically significant). At the time of the report, CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria (hives)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: no unusual findings were reported..         The concomitant medication was not reported by reporter.   She experienced the same issue after receiving the first two doses also, breaking out in chronic hives. She was currently managing the condition with medication.   This case was linked to US-MODERNATX, INC.-MOD-2024-775788 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775788:same reporter
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt very ill; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (felt very ill) in a 38-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In 2024, the patient experienced MALAISE (felt very ill). At the time of the report, MALAISE (felt very ill) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  The patient started therapy with COVID Vaccine. Patient also had a Moderna COVID vaccine last month and felt very ill.   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2024: Live follow up received which contains no new information.
Sex: U
Vaccine: RSV
Symptoms: Device breakage
Clinical narrative: When the product was mixed with the diluent it exploded; When the product was mixed with the diluent it exploded; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 11Oct2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from Other HCPs and Nurses from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: 30Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), DEVICE BREAKAGE (non-serious), outcome "unknown" and all described as "When the product was mixed with the diluent it exploded".  Causality for "when the product was mixed with the diluent it exploded" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).