chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: For almost a year I was immediately affected with a severe rash and uncontrollable pruritus; For almost a year I was immediately affected with a severe rash and uncontrollable pruritus; This non-serious case was reported by a consumer and described the occurrence of pruritus in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number XG7RF) for prophylaxis.   The patient's past medical history included chickenpox (The patient had Chicken Pox as a child.).   On 16-MAR-2023, the patient received Shingrix. On 16-MAR-2023, immediately after receiving Shingrix, the patient experienced pruritus (Verbatim: For almost a year I was immediately affected with a severe rash and uncontrollable pruritus) and rash (Verbatim: For almost a year I was immediately affected with a severe rash and uncontrollable pruritus). The patient was treated with prednisone. The outcome of the pruritus and rash were not resolved.   It was unknown if the reporter considered the pruritus and rash to be related to Shingrix.     It was unknown if the company considered the pruritus and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-FEB-2024 The patient was reporter The patient reported that she received Shingrix vaccine and immediately affected with severe rash and uncontrollable pruritus that presented an enigma. The reported that at the time of reported the symptoms are ongoing. The she stated that the her encouraged by the pharmacist got the vaccine because of her age and the fact that she had chicken pox at the child.
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: allergy; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of allergy in a 67-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra. On an unknown date, an unknown time after receiving Fluarix Tetra, the patient experienced allergy (Verbatim: allergy). The outcome of the allergy was not reported.   It was unknown if the reporter considered the allergy to be related to Fluarix Tetra and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the allergy to be related to Fluarix Tetra and Fluarix Tetra 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: 29-JAN-2024 The patient started treatment on an unreported date with Fluarix Quadrivalent (Influenza vaccine), at an unreported dose route and frequency of administration for an unreported indication.  It was reported the patient had an allergy to Fluarix Quadrivalent.  No further follow-up was anticipated.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Only the diluent was given to the patient; Only the diluent was given to the patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Only the diluent was given to the patient) and inappropriate dose of vaccine administered (Verbatim: Only the diluent was given to the patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-JAN-2024 The reporter stated the patient was administered only the diluent therefore they only had a vial of vaccine with no diluent, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked that there was any way to order just a vial of diluent. The reporter consented to follow up This case was linked with US2024014366, same reporter and product.; Sender's Comments:  US-GSK-US2024014366:Same reporter/product
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster Virus; This non-serious case was reported by a lawyer and described the occurrence of herpes zoster in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced herpes zoster (Verbatim: Herpes Zoster Virus). The outcome of the herpes zoster was not reported.   It was unknown if the reporter considered the herpes zoster to be related to Shingrix.  It was unknown if the company considered the herpes zoster to be related to Shingrix.   Additional Information: GSK receipt date - 07-Feb-2024 As per legal complaints the plaintiff administration Shingrix (PF) and as a result of use of above medication the plaintiff was diagnosed with Herpes Zoster Virus (Shingles).
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient came to the pharmacy on 02/06/2024 and requested an influenza vaccine. Flucelvax Quadravalent was administered in the left deloid of the patient near 11:15 am. Patient returned to the pharmacy 02/08/24. She stated that the area where the vaccine was administered the left deltoid was red and itchy. Patient exposed the left deltoid and I could verify visually that the deltoid area was red. I recommended that the patient take Diphenhydramine for the itching; or rub a small amount of Hydrocortisone 1% on the area that was red and itchy. The left deltoid skin was not broken upon visual inspection.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: pt is 19 years old. she was given adult dose of Engerix-B/ for ages 20 and over
Age: 18.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Nausea
Clinical narrative: Patient felt dizzy, light headed and nauseous.  We had the patient sit down and put a cold pack on the back of her neck.  She sat for about 30 minutes until she felt better and left feeling much better.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient did not have an actual adverse event. But we discovered that the shingrix dose on 12/8/23 was actually her THIRD dose of shingrix (when it should only be a 2 dose series). Patient received 2 previous doses in 2020. She was asked on 12/8/23 if this was her first dose of shingrix and said yes so it was given to her, but when she came 2 months later we found that she did already complete her series in 2020 and did not need the dose given on 12/8/23.
Age: 71.0
Sex: F
Vaccine: FLUX, RVX
Symptoms: Chest pain, Eructation, Flatulence, Neck pain, Painful respiration
Clinical narrative: pain from neck to chest; frequent need to belch; with painful breathing/ hurts to breathe; she began feeling extremely gassy; Neck pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of chest pain in a 71-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 23-JAN-2024, the patient received RSV vaccine and Flu vaccine. On 24-JAN-2024, 1 days after receiving RSV vaccine and Flu vaccine, the patient experienced chest pain (Verbatim: pain from neck to chest), belching (Verbatim: frequent need to belch), painful respiration (Verbatim: with painful breathing/ hurts to breathe), gas (Verbatim: she began feeling extremely gassy) and neck pain (Verbatim: Neck pain). The outcome of the chest pain, belching, painful respiration, gas and neck pain were unknown.   It was unknown if the reporter considered the chest pain, belching, painful respiration, gas and neck pain to be related to RSV vaccine and Flu vaccine.     It was unknown if the company considered the chest pain, belching, painful respiration, gas and neck pain to be related to RSV vaccine and Flu vaccine.   Additional Information: GSK Receipt Date: 25-JAN-2024 The patient self-reported this case. The patient reported that she received an RSV vaccine and a Flu vaccine on the same day. She did not know the brand/manufacturer for either vaccine. She stated that 1 day after vaccination, she began feeling extremely gassy with painful breathing, pain from neck to chest and frequent need to belch. The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique / administered only adjuvant component of AREXY in error; administered only adjuvant component of AREXY in error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 45mg3, expiry date 10-JUL-2025) for prophylaxis.   On 11-JAN-2024, the patient received Arexvy. On 11-JAN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-JAN-2024 The reporter reported that the patient was administered only the adjuvant component of the Arexvy in error which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was 1 of 5 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024013412:Same reporter US-GSK-US2024013413:1st patient,Same reporter US-GSK-US2024013415:Same reporter US-GSK-US2024013414:Same reporter
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: administered only adjuvant component of Arexvy; administered only adjuvant component of Arexvy in error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 45mg3, expiry date 10-JUL-2025) for prophylaxis.   On 11-JAN-2024, the patient received Arexvy. On 11-JAN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: administered only adjuvant component of Arexvy) and inappropriate dose of vaccine administered (Verbatim: administered only adjuvant component of Arexvy in error). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-JAN-2024 The reporter stated that the patient was administered only the adjuvant component of the Arexvy in error, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was 1 of 5 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024013410:Same reporter US-GSK-US2024013412:Same reporter US-GSK-US2024013413:5th patient US-GSK-US2024013414:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: flulaval vaccine was administered after being involved in a temperature excursion; This non-serious case was reported by a nurse via sales rep and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   On 26-JAN-2024, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: flulaval vaccine was administered after being involved in a temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JAN-2024 The nurse reported that a Flulaval vaccine was administered after being involved in a temperature excursion, which led to incorrect storage of drug. Temperature and time of the excursion unknown. The caller stated that, he/she had no details about the patient or vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Age: 0.25
Sex: M
Vaccine: DTAP, DTAPIPV, HEP
Symptoms: Product storage error
Clinical narrative: a patient was administered frozen Kinrix and Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a infant male patient who received HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis and DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 12-DEC-2023, the patient received Engerix B. On an unknown date, the patient received Kinrix. On 12-DEC-2023, the patient received Infanrix. On an unknown date, an unknown time after receiving Engerix B, Kinrix and Infanrix, the patient experienced incorrect storage of drug (Verbatim: a patient was administered frozen Kinrix and Engerix-B). 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:29-JAN-2024 The reporter reported that a patient was administered frozen Kinrix, infanrix and Engerix-B wich led to incorrect storage of drug. On 9th October 2013, the vaccine was went down to minute 26.6 Fahrenheit for 2 hours and 35 minutes. The reporter consented to follow up. This is 1 of 6 cases reported by same reporter.; Sender's Comments:  US-GSK-US2024013461:Same reporter US-GSK-US2024013465:Same reporter US-GSK-US2024013459:Same reporter US-GSK-US2024013460:Same reporter
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: Product storage error
Clinical narrative: vaccine went down to min 26.6F for 2 hrs and 35 minutes; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22-MAR-2024) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On 20-DEC-2023, the patient received Kinrix and Engerix B. On an unknown date, an unknown time after receiving Kinrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: vaccine went down to min 26.6F for 2 hrs and 35 minutes). 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: 29-JAN-2024 A medical assistant reported that a patient was administered frozen Kinrix, on October 9th 2023, the vaccine went down to min 26.6F for 2 hrs and 35 minutes which led to incorrect storage of drug. The reporter Consented to follow up. This is 1 of 6 cases reported by same reporter.; Sender's Comments:  US-GSK-US2024013465:Same reporter US-GSK-US2024013461:Same reporter US-GSK-US2024013460:Same reporter US-GSK-US2024013459:Same reporter
Age: 0.5
Sex: M
Vaccine: DTAP, HEP
Symptoms: Product storage error
Clinical narrative: patient was administered frozen Infanrix and Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 9-month-old male patient who received DTPa (Infanrix) (batch number 9hp9z, expiry date 21-APR-2024) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On 13-NOV-2023, the patient received Infanrix and Engerix B. On an unknown date, an unknown time after receiving Infanrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: patient was administered frozen Infanrix and Engerix-B). 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: 29-Jan-2024 The reporter was a medical assistant. The reporter stated that the patient received frozen Infanrix and Engerix-B.  On 9th October 2023, the vaccine went down to min 26.6 degree F for 2 hrs and 35 minutes. The vaccine was exposed to 26.6 degree Fahrenheit for 2 hours and 35 minutes, which led to incorrect storage of drug The reporter Consented to follow up. This is 1 of 6 cases reported by same reporter.; Sender's Comments:  US-GSK-US2024013465:Same reporter US-GSK-US2024013458:Same reporter US-GSK-US2024013455:Same reporter US-GSK-US2024013459:Same reporter US-GSK-US2024013460:Same reporter
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix expired dose administrated to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received HAV (Havrix) (batch number EP47E, expiry date 06-FEB-2023) for prophylaxis.   On 27-JAN-2024, the patient received Havrix. On 27-JAN-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix expired dose administrated to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-JAN-2024 The pharmacist reported that, Havrix was expired and was administered to a patient which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: not yet receive their second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th November 2020).   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: not yet receive their second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-JAN-2024 The pharmacist reported that till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination. The call was disconnected, and MI (medical information) was unable to reach caller during call back. The follow-up could not be possible as no contact details were available.
Age: 69.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Maladministration Twinrix after expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 69-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 01-JAN-2024) for prophylaxis.   On 05-JAN-2024, the patient received the 2nd dose of Twinrix. On 05-JAN-2024, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Maladministration Twinrix after expiration date). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-JAN-2024 The nurse reported that the patient received second dose of Twinrix which was expired, which led to expired vaccine used. The reporter stated if any side effect had been reported form this patient yet.  The permission to storage healthcare professions details on medical information database was declined.  The reporter consented to follow up via email.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak; This non-serious case was reported by a other health professional via sales rep and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-JAN-2024, the patient received Shingrix. In JAN-2024, less than a week after receiving Shingrix, the patient experienced shingles (Verbatim: shingles outbreak). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JAN-2024 The patient had a shingles outbreak after getting Shingrix.  The patient called to the clinic on 24th January 2024, to report the symptoms. The patient was referred to the dermatologist, and now (at the time of reporting) she was taking Valtrex as treatment, but the symptoms had not abated. The sales representative did not provide information about the dose given (lot number and expiration date). The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired product Used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (expiry date JAN-2024) for prophylaxis.   On 29-JAN-2024, the patient received Shingrix. On 29-JAN-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired product Used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-JAN-2024 The pharmacist reported that a Shingrix vaccine had administered, and only after administration, the administrator noticed that the vaccine was 3 days expired, which led to expired vaccine used. The reporter did not had any patient information, or the product lot number or expiration date. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Hemiplegia
Clinical narrative: developed right side paralysis after receiving the Arexvy vaccine; This serious case was reported by a nurse via sales rep and described the occurrence of right sided paralysis in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced right sided paralysis (Verbatim: developed right side paralysis after receiving the Arexvy vaccine) (serious criteria GSK medically significant). The outcome of the right sided paralysis was unknown.   It was unknown if the reporter considered the right sided paralysis to be related to Arexvy.     It was unknown if the company considered the right sided paralysis to be related to Arexvy.   Additional Information: GSK receipt date: 01-FEB-2024 The HealthCare Professional reported that the patient received Arexvy vaccine and experienced right side paralysis. No further information was available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Received both doses of Shingrix and had a Shingles outbreak in June 2023/suspected vaccination failure; Shingles outbreak in left eye; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JUN-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Received both doses of Shingrix and had a Shingles outbreak in June 2023/suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: Shingles outbreak in left eye) (serious criteria GSK medically significant). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 01-FEB-2024 The reporter was the patient who stated she received both doses of Shingrix when vaccine came out in 2017 and had a Shingles outbreak in left eye. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The reporter did not consent to follow-up.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Deafness unilateral
Clinical narrative: Lost hearing in his left ear; This serious case was reported by a physician via sales rep and described the occurrence of hearing loss unilateral in a 49-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number LP2G2, expiry date 19-SEP-2025) for prophylaxis.   The patient's past medical history included ear disorder (Patient had previous ear issues due to a viral infection) and viral infection (Patient had a Viral infection).   On 17-MAY-2023, the patient received Boostrix (right deltoid). On an unknown date, an unknown time after receiving Boostrix, the patient experienced hearing loss unilateral (Verbatim: Lost hearing in his left ear) (serious criteria GSK medically significant). The outcome of the hearing loss unilateral was unknown.   It was unknown if the reporter considered the hearing loss unilateral to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the hearing loss unilateral to be related to Boostrix and Boostrix 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: 01-FEB-2024 The patient was phsycian. The physician reported that after receiving the Boostrix vaccine he lost hearing in his left ear. The reporter/patient stated that he had previous ear issues due to a viral infection. The reporter did not mention when the symptoms started nor if he had recovered his hearing. The reporter requested to consent the follow up.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Antibody test negative, Therapeutic response decreased
Clinical narrative: however her titers were checked and they were too low; This non-serious case was reported by a physician via call center representative and described the occurrence of therapeutic response decreased in a 20-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   In JUL-2004, the patient received the 1st dose of Engerix B. In JAN-2004, the patient received Engerix B. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased (Verbatim: however her titers were checked and they were too low). The outcome of the therapeutic response decreased was unknown.   Additional Information: GSK Receipt Date: 01-FEB-2024 The reporter declined to provide patient initials.  The reporter reported that she had a 20-year-old patient who previously had Engerix-B series in 2004, however her titers were checked and they were too low, so the physician planned to repeat the series, which led to therapeutic response decreased. At the time of reporting no further doses had been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not obtain lot numbers from 2004 series, report stated she did not have time to answer questions. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: the administration of a pediatric dose of Havrix in an adult patient; the administration of a pediatric dose of Havrix in an adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 69-year-old male patient who received HAV (Havrix 720) (batch number 2X2EJ, expiry date 14-OCT-2024) for prophylaxis.   On 01-FEB-2024, the patient received the 1st dose of Havrix 720. On 01-FEB-2024, an unknown time after receiving Havrix 720, the patient experienced underdose (Verbatim: the administration of a pediatric dose of Havrix in an adult patient) and adult use of a child product (Verbatim: the administration of a pediatric dose of Havrix in an adult patient). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 02-FEB-2024 A pharmacist inquiring about Havrix that what information was available about any information about the administration of a pediatric dose of Havrix in an adult patient. Information about the vaccine, patient and event was given.  An adult patient received pediatric dose of Havrix which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: MEDICAL ISSUES; This spontaneous report received from a consumer (family member) concerned a patient of unspecified age and sex via social media. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose (dose number in series: 1), start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The company is unable to request the batch number. No concomitant medications were reported. On an unspecified date, the patient had medical issues (dose number in series: 1) after being vaccinated.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medical issues was not reported. This report was non-serious. This case, from the same reporter is linked to 20240156462 and 20240164979.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: has redness, swelling, itchiness, and pain at the injection site; has redness, swelling, itchiness, and pain at the injection site; has redness, swelling, itchiness, and pain at the injection site; has redness, swelling, itchiness, and pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE ERYTHEMA (has redness, swelling, itchiness, and pain at the injection site), INJECTION SITE SWELLING (has redness, swelling, itchiness, and pain at the injection site), INJECTION SITE PRURITUS (has redness, swelling, itchiness, and pain at the injection site) and INJECTION SITE PAIN (has redness, swelling, itchiness, and pain at the injection site) in a 33-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 31-Jan-2024, the patient experienced INJECTION SITE ERYTHEMA (has redness, swelling, itchiness, and pain at the injection site), INJECTION SITE SWELLING (has redness, swelling, itchiness, and pain at the injection site), INJECTION SITE PRURITUS (has redness, swelling, itchiness, and pain at the injection site) and INJECTION SITE PAIN (has redness, swelling, itchiness, and pain at the injection site). On 04-Feb-2024, INJECTION SITE ERYTHEMA (has redness, swelling, itchiness, and pain at the injection site), INJECTION SITE SWELLING (has redness, swelling, itchiness, and pain at the injection site), INJECTION SITE PRURITUS (has redness, swelling, itchiness, and pain at the injection site) and INJECTION SITE PAIN (has redness, swelling, itchiness, and pain at the injection site) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-033752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033752:different suspect (Same patient)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes under arm that the shot was given; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): US-MODERNATX-MOC20231116000006 (MODERNATX), MOD-2023-749841 (MODERNATX).  A 39-year-old female patient received BNT162b2 (BNT162B2 NOS), on 13Nov2023 as dose numer unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 14Nov2023, outcome "not recovered", described as "swollen lymph nodes under arm that the shot was given".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient came in for a visit on 07/31/23 and was 11 years old at the time. The patient was given a COVID vaccine for 12 years and above. There was no documentation of two people having verified it was correct vaccine selected.  No adverse reaction was noted by the parents.  It did not result in any harm  to the patient. Doctor was made aware and she contacted the parents of the patient.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Vomiting
Clinical narrative: Patient had post-vaccine anxiety and vomitted in the waiting area. 911 was called, but by the time they arrived, she already felt better and she was released quickly
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received duplicate Arexvy vaccinations at Pharmacy on 08/31/23 and 09/29/23. Patient does not report any side effects associated with the duplicate vaccinations at this time. Pharmacy team made aware of issue when insurance inquired regarding duplicate billing. I then reported all of the above findings to Pharmacy corporately and followed policies and procedures in place.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Headache, Hypertension, Laboratory test, Mental impairment
Clinical narrative: Patient states "high blood pressure 195/84, intense sore throat for over 2 weeks, headache, nausea, no energy, and can't think straight"
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Oropharyngeal pain
Clinical narrative: Patient states "high blood pressure 195/84, intense sore throat for over 2 weeks, headache, nausea, no energy, and can't think straight"
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large red hot, painful rash surrounding site about 5 inches around.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal discomfort, Decreased appetite, Nausea, Rash, Vomiting
Clinical narrative: Per mother symptoms onset 2 hrs after vaccine :Nausea, vomiting, decreased appetite, abdominal  discomfort and abdominal rash. Mother monitoring at home reports symptoms have improved, declined follow appointment with PCP.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Feeling of body temperature change, Mobility decreased, Pyrexia
Clinical narrative: Patient came in on 2/8/24 to report severe reaction to the Comirnaty Vaccination she received on 1/16/24. She asked to have her symptoms reported, symptoms starting evening vaccination was administered she felt hot, then cold and back and forth hot then cold. She had fever and chills for next three days and felt she had to stay in bed. She has had covid vaccinations in past with no problems.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient forgot that he had the rsv vaccine in novemeber of 2023, he made an appointment online to do rsv vaccine, patient came to the pharmacy and I asked if he was doing the RSV and if he had any questions, counseled on the vaccine and side effects, patient approved to do in the left arm, the system did not have any hard stops that he got it in november. After the vaccine was administered, patient requested a proof of vaccination form,. When I went to print the form to give to him,  I saw patient already recieved rsv in november, I asked if he remembered , he said no, he does not remember that he got it. He apologized. Patient ended up getting 2 rsv vaccines. Counseled on monitoring for any reactions and to drink water and take tylenol. Called patient in the afternoon, he said he felt fine and didnt feel anything.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Erythema, Mobility decreased, Raynaud's phenomenon
Clinical narrative: Reynauds syndrome episodes ? tip of one finger. Variable finger) knees bright red, burning, left wrist sudden swelling, impaired mobility, very painful. Messaged my doctor about my wrist.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Reynauds syndrome episodes ? tip of one finger. Variable finger) knees bright red, burning, left wrist sudden swelling, impaired mobility, very painful. Messaged my doctor about my wrist.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Swollen Lymph nodes for about a week and sore right arm at injection site.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Balance disorder, Clumsiness, Fatigue, Gait disturbance
Clinical narrative: 11-2-23 (2) days after vacc. symptoms started. Extreme head & neck pain, pressure at base of skull & forehead & top of head, sleep disturbance - (3) days later, low back pain radiating down both legs, bent over at waist, unable to elevate torso, feet scuffing on any walkings. Equilibrium affected, poor balance, clumsy & both arm & hands weak Incontinent of urine, day & night - new unable to sleep through nite (in bed) due to head & neck pain, necessitating moving to chair or recliner at some point during night. Easily fatigues (-) Covid (home test) on (11-15-24)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Mobility decreased, Muscular weakness, Neck pain
Clinical narrative: 11-2-23 (2) days after vacc. symptoms started. Extreme head & neck pain, pressure at base of skull & forehead & top of head, sleep disturbance - (3) days later, low back pain radiating down both legs, bent over at waist, unable to elevate torso, feet scuffing on any walkings. Equilibrium affected, poor balance, clumsy & both arm & hands weak Incontinent of urine, day & night - new unable to sleep through nite (in bed) due to head & neck pain, necessitating moving to chair or recliner at some point during night. Easily fatigues (-) Covid (home test) on (11-15-24)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test negative, Sleep disorder, Urinary incontinence
Clinical narrative: 11-2-23 (2) days after vacc. symptoms started. Extreme head & neck pain, pressure at base of skull & forehead & top of head, sleep disturbance - (3) days later, low back pain radiating down both legs, bent over at waist, unable to elevate torso, feet scuffing on any walkings. Equilibrium affected, poor balance, clumsy & both arm & hands weak Incontinent of urine, day & night - new unable to sleep through nite (in bed) due to head & neck pain, necessitating moving to chair or recliner at some point during night. Easily fatigues (-) Covid (home test) on (11-15-24)
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, DTAP, FLUX, HEP, PNC13, DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Cardiac arrest, Cardiac death
Clinical narrative: Cardiac arrest; This spontaneous report was received from a physician via other company via company representative and refers to a 1-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-JAN-2020, the patient was vaccinated with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); and  influenza vaccine inact split 4v (FLUZONE QUADRIVALENT) administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).   On 16-JAN-2020, the patient experienced cardiac arrest. On the same date, she died due to the event. An autopsy was not performed.   The causal relationship between cardiac arrest and the suspect vaccines was not provided.  Upon internal review, the event cardiac arrest was determined to be medically significant.  This is one of two cases from the same reporter.; Reported Cause(s) of Death: Cardiac arrest
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, DTAP, FLUX, HEP, PNC13, DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Cardiac arrest, Death, Respiratory arrest, Resuscitation
Clinical narrative: Cardiac arrest; This spontaneous report was received from a physician via other company via company representative and refers to a 1-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-JAN-2020, the patient was vaccinated with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); and  influenza vaccine inact split 4v (FLUZONE QUADRIVALENT) administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).   On 16-JAN-2020, the patient experienced cardiac arrest. On the same date, she died due to the event. An autopsy was not performed.   The causal relationship between cardiac arrest and the suspect vaccines was not provided.  Upon internal review, the event cardiac arrest was determined to be medically significant.  This is one of two cases from the same reporter.; Reported Cause(s) of Death: Cardiac arrest
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, DTAP, FLUX, HEP, PNC13, DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Cardiac arrest, Death
Clinical narrative: Cardiac arrest; This spontaneous report was received from a physician via other company via company representative and refers to a 1-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-JAN-2020, the patient was vaccinated with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); and  influenza vaccine inact split 4v (FLUZONE QUADRIVALENT) administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).   On 16-JAN-2020, the patient experienced cardiac arrest. On the same date, she died due to the event. An autopsy was not performed.   The causal relationship between cardiac arrest and the suspect vaccines was not provided.  Upon internal review, the event cardiac arrest was determined to be medically significant.  This is one of two cases from the same reporter.; Reported Cause(s) of Death: Cardiac arrest
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient received Moderna booster and a few days later he started getting hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Patient received Moderna booster and a few days later he started getting hives) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Cholesterol blood increased, Triglycerides high and Urticaria. Concomitant products included ATORVASTATIN and OMEGA-3-ACID ETHYL ESTER (LOVAZA) for an unknown indication.    On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced URTICARIA (Patient received Moderna booster and a few days later he started getting hives). At the time of the report, URTICARIA (Patient received Moderna booster and a few days later he started getting hives) outcome was unknown.            No treatment medication was reported.
Sex: M
Vaccine: RSV, RSV
Symptoms: Electromyogram, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: GBS-Guillain-Barre Syndrome; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2731680-1 (VAERS ID).  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Jan2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "High Blood Pressure" (ongoing). Concomitant medication(s) included: BYSTOLIC; VALSARTAN. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant) with onset 17Jan2022, outcome "not recovered", described as "GBS-Guillain-Barre Syndrome". The patient was hospitalized for guillain-barre syndrome (hospitalization duration: 40 day(s)). The patient underwent the following laboratory tests and procedures: Electromyogram: Unknown Results; Lumbar puncture: Unknown Results. Clinical course: reported age (66; unit: unknown).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.