chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Feeling abnormal, Feeling cold, Pain, Paraesthesia
Clinical narrative: Patient describes symptoms of paresthesia. Stated she experienced burning and pain within minutes after vaccination. Sensation turned to cold arm and feeling cold, Shakey and feeling not right.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Peripheral coldness, Tremor
Clinical narrative: Patient describes symptoms of paresthesia. Stated she experienced burning and pain within minutes after vaccination. Sensation turned to cold arm and feeling cold, Shakey and feeling not right.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Malaise
Clinical narrative: Patient presented to the pharmacy requesting a flu vaccine. The patient completed our Vaccine Administration Record - Informed Consent for Vaccination, which included the question: "Have you ever had a reaction after receiving  a vaccine, including fainting or feeling dizzy?" Patient responded "NO" that they never had a reaction in the past. After receiving the vaccine, the patient stated they did not feel well. Both myself (Pharmacist) and my technician took turns staying with the patient as he began to sweat and state he felt dizzy/faint. After approximately 10-15 minutes, the patient requested an ambulance as he did not feel safe to transport himself to the local Emergency Room. Patient remained alert and was able to communicate with both the technician and pharmacist during the entire time; patient remained alert during EMT coming via ambulance to pick patient up. Patient declared he never had this type of reaction before to a vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, HD offered revaccination of FLU vaccine, facility declined
Age: 82.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Brain fog, Malaise, Nausea
Clinical narrative: NAUSEA, MENTAL FOG AND GENERAL MALAISE OVER THE LAST 8 DAYS WITHOUT RESOLVE.  GAVE PATIENT OPTIONS FOR SYMPTOMATIC TREATMENT OF NAUSEA.
Age: 34.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction reported, immunization administered with 5/8 inch needle in lieu of 1 inch needle. State immunization consultant notified, health department offered revaccination of FLU vaccine, facility declined
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received vaccines prior to timeframe of 6 weeks. Vaccines listed were given at almost 3 weeks. No side effects or symptoms. Per database, vaccines are all safe, just not valid. No treatment needed and patient's mother notified.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: She received an additional Fluad shot this year. First one was on 8/1/24
Age: 52.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I tested positive for Covid three weeks later
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: The patient had received a dose of RSV in March 2024. She was administered an additional dose on 10/08/2024
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reported that PROQUAD was administered following a temperature excursion.; NO ADVERSE EVENT; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition, concomitant therapies were not reported.  On an unknown date, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #Y009106, expiration date: 06-NOV-2025) was temperature excursion. On an unknown day, this vaccine was given to the patient, subcutaneous injection, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse event.
Age: 40.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE EVENT; PROQUAD was administered to a 40-year-old patient; This spontaneous report was received from medical assistant and refers to a 40-year-old female patient. The patient's medical history, concurrent condition, concomitant therapies were not reported.  On 11-OCT-2024, the patient vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, administered for prophylaxis (lot #Y013572, expiration date: 03-FEB-2026)(strength, and route of administration were not provided) (Product administered to patient of inappropriate age). No side effects or symptoms reported. No Additional information provided.
Sex: F
Vaccine: HPV9
Symptoms: Granuloma, Limb mass, Magnetic resonance imaging
Clinical narrative: patient developed a subcutaneous granuloma following their second dose of GARDASIL 9; This spontaneous report was received from a physician and refers to a 15-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On unknown dates (before patient's 15th birthday), the patient received the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided).  On an unknown date, the patient experienced a subcutaneous granuloma following their second dose. There appears to be between a golf ball and tennis ball sized lump on the arm. The MRI was performed but did not report any result. The surgeon was consulted. The outcome of the event was not reported.   The reporter did not provide the causal relationship between patient developed a subcutaneous granuloma following their second dose of GARDASIL 9 and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The consulted surgeon considered the event was secondary to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Contusion, Injection site rash, Peripheral swelling, Urticaria
Clinical narrative: patient had a bump and rash at the site of reaction; patient had a bump and rash at the site of reaction/there is a welt on the patient's leg; she has a "lasting bruise".; This spontaneous report has been received from a consumer via company representative, regarding a 4-year-old female patient. The patient's previous allergies, medical history, concurrent conditions, and concomitant medications were not provided.  On unspecified date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live) (PROQUAD) injection, intramuscularly administrated (strength, dose, frequency, vaccination scheme, site of vaccination, lot #, and expiration date were not provided) as a prophylaxis.     On 11-OCT-2024 (Friday), the patient experienced a bump (welt) on the patient's leg, rash at the site of injection, and lasting bruise (vaccination site mass, vaccination site rash, and vaccination site bruising). On 12-OCT-2024, the patient sought medical attention and went to the emergency department, where she received a shot of cephalexin, and was sent home with a prescription of cephalexin liquid to be taken three times a day (TID) for one week. No further clarifications were provided. At the reporting time, the outcome of the events were not provided.      The causal relationship between suspect vaccine with the events was considered as related (site reaction to the vaccine).
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse side effects were reported; a patient had an interrupted schedule of GARDASIL 9. She had two at age 16, and one today at 33 years old; This spontaneous report has been received from a physician, referring to a 33-year-old female patient. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On an unknown date in approximately 2007 (discrepancy, the vaccine was not manufactured yet), the patient was vaccinated with 1st and 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered for prophylaxis (dose, route of administration, anatomical location, lot# and expiry date were not reported). On 29-OCT-2024, the patient was vaccinated with 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered for prophylaxis (dose, route of administration, anatomical location, lot# and expiry date were not reported) (Inappropriate schedule of product administration). No adverse side effects were reported (No adverse event).  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: the student did not receive the full 3rd dose; the needle hub began to leak; Poor quality device administered; no AE; This spontaneous report was received from Physician and referred to a 21-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient received the third dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered for prophylaxis (strength, dose lot #, expiry date, and route of administration were not provided), while administering it, the needle hub began to leak and the patient did not receive the full 3rd dose (accidental underdose, needle leak, poor quality device used). No adverse event was reported (no adverse event).
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient received a dose of Engerix-B and after administration they realized that the vaccine expires yesterday; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 48-year-old male patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On 08-OCT-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: patient received a dose of Engerix-B and after administration they realized that the vaccine expires yesterday). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-OCT-2024 A nurse reported that a patient received a dose of Engerix-B and after administration they realized that the vaccine was expired, which led expired vaccine used. The nurse asked if they need to repeat the dose.  The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Syringe issue, Underdose
Clinical narrative: portion squirted out of the syringe" of a Fluarix dose during administration.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 61-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 4799G, expiry date 12-OCT-2026) for prophylaxis.   On 08-OCT-2024, the patient received Fluarix 2024-2025 season. On 08-OCT-2024, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced accidental underdose (Verbatim: portion squirted out of the syringe" of a Fluarix dose during administration.). The outcome of the accidental underdose 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: 08-OCT-2024 A healthcare professional called and informed that a medical assistant informed that a portion squirted out of the syringe of a Fluarix dose during administration which led to accidental underdose. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate preparation of medication; Inappropriate dose of vaccine administered; 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 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number LL942, expiry date 23-MAR-2025) 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: Inappropriate preparation of medication) 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: 08-OCT-2024 and 09-OCT-2024 The healthcare professional reported that they gave only a portion of Arexvy which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Upon follow up the healthcare professional stated that the patient received only the adjuvant portion of Arexvy and that it was not reconstituted.
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Product Storage Error and Administration; 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 female patient who received HAV (Havrix 720) (batch number 423NL, expiry date 16-NOV-2025) for prophylaxis.   On an unknown date, the patient received Havrix 720. On an unknown date, an unknown time after receiving Havrix 720, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error and Administration). 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: 08-OCT-2024 CMA stated that Havrix was exposed to 48.8 Fahrenheit for 78 hours, 35 minutes. It was administered to a patient which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123934:Same reporter/Different patient US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123928:Same reporter/Different patient US-GSK-US2024123926:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123922:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123919:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123909:Same reporter/Different patient US-GSK-US2024123905:Same reporter/Different patient US-GSK-US2024123901:Same reporter/Different patient US-GSK-US2024123899:Same reporter/Different patient US-GSK-US2024123897:Same reporter/Different patient US-GSK-US2024123897:Same reporter/Different patient
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient.; 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 child female patient who received HAV (Havrix 720) (batch number 423NL, expiry date 16-NOV-2025) for prophylaxis.   On an unknown date, the patient received Havrix 720. On an unknown date, an unknown time after receiving Havrix 720, the patient experienced incorrect storage of drug (Verbatim: Havrix was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient.). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-OCT-2024 The reporter stated that Havrix was exposed to 48.8 F for 78 hours, 35 min and it was administered to a patient, which led to incorrect storage of vaccine. The reporter consented to follow up via email.; Sender's Comments:  US-GSK-US2024123897:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123901:same reporter/different patient US-GSK-US2024123905:same reporter/different patient US-GSK-US2024123909:same reporter/different patient US-GSK-US2024123911:same reporter/different patient US-GSK-US2024123919:same reporter/different patient US-GSK-US2024123915:same reporter/different patient US-GSK-US2024123920:same reporter/different patient US-GSK-US2024123922:same reporter/different patient US-GSK-US2024123924:same reporter/different patient US-GSK-US2024123926:same reporter/different patient US-GSK-US2024123928:same reporter/different patient US-GSK-US2024123932:same reporter/different patient US-GSK-US2024123934:same reporter/different patient US-GSK-US2024123936:same reporter/different patient
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Product Storage Error and Administration; 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 female patient who received HAV (Havrix 720) (batch number 423NL, expiry date 16-NOV-2025) for prophylaxis.   On an unknown date, the patient received Havrix 720. On an unknown date, an unknown time after receiving Havrix 720, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error and Administration). 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: 08-OCT-2024 CMA stated that Havrix was exposed to 48.8 Fahrenheit for 78 hours, 35 minutes. It was administered to a patient which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123899:same reporter/different patient US-GSK-US2024123897:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Product Storage Error and Administration; 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 male patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error and Administration). 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: 08-OCT-2024 CMA stated that Bexsero was exposed to 48.8 Fahrenheit for 78 hours, 35 minutes. It was administered to a patient which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123899: US-GSK-US2024123897:Same reporter/Different patient US-GSK-US2024123928:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Product Storage Error and Administration; 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 female patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error and Administration). 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: 08-OCT-2024 CMA stated that Bexsero was exposed to 48.8 Fahrenheit for 78 hours, 35 minutes. It was administered to a patient which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123928:Same reporter/Different patient US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123934:Same reporter/Different patient US-GSK-US2024123926:Same reporter/Different patient US-GSK-US2024123922:Same reporter/Different patient US-GSK-US2024123919:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123909:Same reporter/Different patient US-GSK-US2024123905:Same reporter/Different patient US-GSK-US2024123899: US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123897:Same reporter/Different patient
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero was exposed to 48.8 F for 78 hrs, 35 min; 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 male patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero was exposed to 48.8 F for 78 hrs, 35 min). 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: 08-OCT-2024 CMA stated that Bexsero was exposed to 48.8 Fahrenheit for 78 hours, 35 minutes. It was administered to a patient which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123934:Same reporter/Different patient US-GSK-US2024123926:Same reporter/Different patient US-GSK-US2024123922:Same reporter/Different patient US-GSK-US2024123919:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123909:Same reporter/Different patient US-GSK-US2024123905:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123899: US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123897:Same reporter/Different patient
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Fluarix administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a specified number of patients who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number K9XL5, expiry date 30-JUN-2025) for prophylaxis.   In OCT-2024, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Fluarix administration after 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: 09-OCT-2024 The pharmacist reported that Fluarix suffer a temperature excursion and administered to 10 patients, which led to an incorrect storage of drug. The vaccine administration facility was the same as primary reporter. Information for specific patients was asked and declined. No exact vaccination date, it was asked and reporter stated it happened last week in OCT-2024 (from the date of reporting). The temperature reported was out of the extra stability information, so there was no information to support use of vaccines.
Sex: U
Vaccine: HEP, HEPA, MNQ
Symptoms: Product storage error
Clinical narrative: Administration of Menveo, Havrix and Engerix-B vaccines after a temperature excursion; 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 patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Menveo, Havrix and Engerix B. On an unknown date, an unknown time after receiving Menveo, Havrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: Administration of Menveo, Havrix and Engerix-B vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2024 Medical Assistant reported a temperature excursion freezing temperatures for several GlaxoSmithKline vaccines. Both excursions occurred on a mobile clinic temperature excursion 1: maximum 48.9 F for 5 minutes and minimum 27.1 F for 3 hours and 45 minutes. Temperature excursion 2: Another temperature excursion a few days later. Maximum: 48.7 for 30 Minimum and Minimum 31.1F for 1 hour and 6 minutes. Menveo was administered as well as havrix and Engerix-B.  The reporter consented to follow up.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 17-OCT-2024, the patient received the 2nd dose of Shingrix (left arm). In OCT-2024, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Fever). On 18-OCT-2024, the patient experienced headache (Verbatim: Headache). The outcome of the headache was not resolved and the outcome of the fever was unknown.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.     It was unknown if the company considered the headache and fever to be related to Shingrix.   Additional Information: GSK receipt date: 18-OCT-2024 89 year old female patient reported that she received her second dose of Shingrix yesterday on 17-OCT-2024, in her left arm, and reported that she had a slight fever during the night. The patient also reported that today, 18-OCT-2024, she had a headache. The patient was not able to get to her paperwork from the administration of her vaccine. The patient received her first dose of Shingrix in July 2024.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these Fluarix were given after the temperature excursion which led to incorrect product storage error. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 2 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128724:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128736:same reporter/different patient US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128741:same reporter/different patient US-GSK-US2024128719:same reporter/different patient US-GSK-US2024128756:same reporter/different patient US-GSK-US2024128716:same reporter/different patient US-GSK-US2024128767:same reporter/different patient
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-OCT-2024 The reporter reported that that they had a refrigerator that went out of temperature range and, it did not get super-hot before they set it, but a number of these Fluarix were given after the temperature excursion which led to, incorrect storage of drug. The vaccine was out of storage conditions that was 56°F for 135 hours. The pharmacist said that the vaccines were given to 17 patients, but he gave the initials of 20 patients. HCP (Healthcare professional) did not had the gender nor the DOB (Date of birth) of the patients at the time of the call. HCP was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 8 of 20 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128724:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128736:same reporter/different patient US-GSK-US2024128716:same reporter/different patient US-GSK-US2024128719:same reporter/different patient US-GSK-US2024128734:same reporter/different patient US-GSK-US2024128740:same reporter/different patient US-GSK-US2024128741:same reporter/different patient US-GSK-US2024128747:same reporter/different patient US-GSK-US2024128750:same reporter/different patient US-GSK-US2024128756:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128767:same reporter/different patient US-GSK-US2024128774:same reporter/different patient
Age: 22.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 22 year old pateint recived Shingrix vaccine; 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 22-year-old female patient who received Herpes zoster (Shingrix) (batch number X017489, expiry date 25-JUN-2025) for prophylaxis.   On 04-OCT-2024, the patient received Shingrix. On 04-OCT-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 22 year old pateint recived Shingrix vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 18-OCT-2024 The reporter reported that they accidentally gave a zoster vaccine to the patient. According to reporter the patient was 22-year-old patient which led to, inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Age: 28.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: A pregnant woman received a dose of Arexvy.; A pregnant woman received a dose of Arexvy; pregnant female patient was inadvertently administered a dose of Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 35AD3, expiry date 23-JAN-2025) for prophylaxis.   Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis.   On 23-OCT-2024, the patient received Arexvy. On an unknown date, the patient did not receive Abrysvo. On 23-OCT-2024, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved population (Verbatim: A pregnant woman received a dose of Arexvy) and wrong vaccine administered (Verbatim: pregnant female patient was inadvertently administered a dose of Arexvy instead of Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: A pregnant woman received a dose of Arexvy.). The outcome of the vaccine exposure during pregnancy, drug use in unapproved population and wrong vaccine administered were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 23-OCT-2024 and 24-OCT-2024 The nurse practitioner reported that a pregnant patient was inadvertently administered a dose of Arexvy instead of Abrysvo, which led vaccine exposure during pregnancy, drug use in unapproved population and wrong vaccine administered.  The patient did not had any reaction The Vaccine Administration Facility was the same as Primary Reporter The reporter asked was there any safety information regarding this situation.
Age: 28.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: A pregnant woman received a dose of Arexvy.; A pregnant woman received a dose of Arexvy; pregnant female patient was inadvertently administered a dose of Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 35AD3, expiry date 23-JAN-2025) for prophylaxis.   Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis.   On 23-OCT-2024, the patient received Arexvy. On an unknown date, the patient did not receive Abrysvo. On 23-OCT-2024, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved population (Verbatim: A pregnant woman received a dose of Arexvy) and wrong vaccine administered (Verbatim: pregnant female patient was inadvertently administered a dose of Arexvy instead of Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: A pregnant woman received a dose of Arexvy.). The outcome of the vaccine exposure during pregnancy, drug use in unapproved population and wrong vaccine administered were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 23-OCT-2024 and 24-OCT-2024 The nurse practitioner reported that a pregnant patient was inadvertently administered a dose of Arexvy instead of Abrysvo, which led vaccine exposure during pregnancy, drug use in unapproved population and wrong vaccine administered.  The patient did not had any reaction The Vaccine Administration Facility was the same as Primary Reporter The reporter asked was there any safety information regarding this situation.
Age: 74.0
Sex: M
Vaccine: CHIK, JEV1
Symptoms: Asthenia, Cardiomyopathy, Condition aggravated, Fatigue, Hypotension
Clinical narrative: Severe cardiomyopathy; Weakness; Fatigue; Hypotension; The following information was received from a physician via service provider on 30 Oct 2024.  A 74-year-old male received one dose each of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number not reported) and IXIARO (Japanese encephalitis vaccine, batch number not reported). Both vaccinations were administered on 08 Oct 2024 or 09 Oct 2024 [reporter not sure, therefore Oct 2024 was entered].   Relevant medical history included ischemic cardiomyopathy.  After vaccination, on an unknown date, he experienced severe cardiomyopathy, weakness, fatigue and hypotension. He was treated with Midodrine to raise his blood pressure.   Outcome of all events was reported as resolved.; Sender's Comments: IXCHIQ: Causality assessed as excluded for the adverse event Cardiomyopathy, which was assessed by company as serious due to medically importance, as medical history of Ischemic cardiomyopathy is a strong confounding factor and a better explanation for the occurrence of this event. In addition, more precise therapy and onset data are not known, which would allow a better assessment of the condition. Causality assessed as possibly related for Weakness and Fatigue as both events are well known to IXCHIQ indicative of a systemic vaccination reaction. In this medical context and in combination with the rather high age of the vaccinated person of 74 years, the event hypotension is also to be seen and a causal connection with the vaccination is therefore possible. Nevertheless, the combined vaccination with IXIARO on the same day must also be taken into account as a cause.  IXIARO: Causality assessed as excluded for the adverse event Cardiomyopathy, which was assessed by company as serious due to medically importance, as medical history of Ischemic cardiomyopathy is a strong confounding factor and a better explanation for the occurrence of this event. In addition, more precise therapy and onset data are not known, which would allow a better assessment of the condition. Causality assessed as possibly related for Weakness and Fatigue as both events are well known to IXIARO indicative of a systemic vaccination reaction. In this medical context and in combination with the rather high age of the vaccinated person of 74 years, the event hypotension is also to be seen and a causal connection with the vaccination is therefore possible. Nevertheless, the combined vaccination with IXCHIQ on the same day must also be taken into account as a cause.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Near death experience, Nervous system disorder
Clinical narrative: Moderna Covid-19 Vaccination when Covid first came out also nearly killed me as well; messed with my nerve systems; I have been having a hard time sleeping on and off almost every night ever since; This spontaneous case was reported by a patient and describes the occurrence of NEAR DEATH EXPERIENCE (Moderna Covid-19 Vaccination when Covid first came out also nearly killed me as well) and NERVOUS SYSTEM DISORDER (messed with my nerve systems) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (Moderna Covid-19 Vaccination when Covid first came out also nearly killed me as well) (seriousness criterion medically significant), NERVOUS SYSTEM DISORDER (messed with my nerve systems) (seriousness criterion medically significant) and INSOMNIA (I have been having a hard time sleeping on and off almost every night ever since). At the time of the report, NEAR DEATH EXPERIENCE (Moderna Covid-19 Vaccination when Covid first came out also nearly killed me as well), NERVOUS SYSTEM DISORDER (messed with my nerve systems) and INSOMNIA (I have been having a hard time sleeping on and off almost every night ever since) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available. No treatment medications were reported.   This case was linked to MOD-2024-776161 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin irritation
Clinical narrative: irritation of injected arm; redness of the inject arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of skin irritation in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 3KB44, expiry date 21-APR-2025) for prophylaxis.   On 09-JUL-2024, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced skin irritation (Verbatim: irritation of injected arm) and erythema of extremities (Verbatim: redness of the inject arm). The outcome of the skin irritation and erythema of extremities were resolved.   It was unknown if the reporter considered the skin irritation and erythema of extremities to be related to Shingrix.     It was unknown if the company considered the skin irritation and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-OCT-2024 The pharmacist reported that the patient received first dose of Shingrix vaccine and initially in 2024, she experienced redness and irritation of the inject arm (left) in a small area, but within 1 day, it grew larger subsequently covering her entire arm, which lasted for about 1 week or so in 2024. The reporter provided Shingrix lot number and expiration date, but 3KB44 did not show up as a valid lot number.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Noninfective encephalitis
Clinical narrative: Brain inflammation, memory loss, etc; This spontaneous case was reported by a patient and describes the occurrence of NONINFECTIVE ENCEPHALITIS (Brain inflammation, memory loss, etc) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.  On 28-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 28-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NONINFECTIVE ENCEPHALITIS (Brain inflammation, memory loss, etc) (seriousness criterion medically significant). The patient was treated with Escitalopram oxalate (Lexapro) at a dose of 5 milligram once a day and Ubidecarenone (Coq10) at a dose of 200 milligram once a day. At the time of the report, NONINFECTIVE ENCEPHALITIS (Brain inflammation, memory loss, etc) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient had seen ENT, neurologist, endocrinologist, general practitioner, psychiatrist. There were no additional lab data/results available. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.