chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: HBP reports the patient had a negative titer for MMR II and VARIVAX despite being fullly vaccinated; HBP calling to report an inadvertent administration of PROQUAD to a 20 year old.; Office inadvertently administered PROQUAD with the intention of administering MMR II AND VARIVAX as 2 seprate vaccines.; This spontaneous report was received from an office manager and refers to a 20-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 18-JUL-2023 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (exact dose, dose number, route and ste of administration, lot number and expiration date were not provided) instead of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (product administered to patient of inappropriate age and wrong product administered).    On an unknown date the patient experienced antibody test negative. The outcome of antibody test negative was unknown. Action taken with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) regarding the event was not applicable.   The causality between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and the event was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; a patient was administered an improperly stored VARIVAX vaccine.; This spontaneous report was received from a consumer referring to a patient of unknown age and gender.     The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 03-AUG-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # W039689, expiration date on 13-DEC-2024, for prophylaxis (dosage, frequency, route, anatomical location were not reported). No additional adverse event was reported.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist has no further information on AE; HCP called to reports that a patient received the first dose of GARDASIL 9 on 3/30/2023, the second dose on 5/30/2023 according to the prescribing information. However, the third dose was given today 8/4/2023. Only 9 weeks and 3 days after the 2nd do; This spontaneous report was received from a pharmacist and refers to a 25-year-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.   On 30-MAR-2023 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On 30-MAY-2023 the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On 30-MAR-2023 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided).  On 04-AUG-2023 the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis, lot number W030851 and expiration date 08-JAN-2025, 0.5 milliliters (route and site of administration were not provided) (inappropriate schedule of product administration and no adverse event).
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Peripheral swelling, Skin warm
Clinical narrative: Healthcare worker reported that a patient developed injection site reaction after receiving PNEUMOVAX 23.  The patient's arm was swollen and warm to the touch.   No additional AEs were reported. No further information provided.  No PQC.; Healthcare worker reported that a patient developed injection site reaction after receiving PNEUMOVAX 23.  The patient's arm was swollen and warm to the touch.   No additional AEs were reported. No further information provided.  No PQC.; Healthcare worker reported that a patient developed injection site reaction after receiving PNEUMOVAX 23.  The patient's arm was swollen and warm to the touch.   No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from Other Health Professional and refers to a 34-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included salbutamol (ALBUTEROL HFA), bictegravir sodium (+) emtricitabine (+) tenofovir alafenamide fumarate (BIKTARVY), clindamycin (CLINDAMYCIN), cyclobenzaprine (CYCLOBENZAPRINE), nicotine (NICOTINE), curcuma longa rhizome (+) piper nigrum fruit (TURMERIC +) and varenicline (VARENICLINE).   On 30-JUN-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #W007035, expiration date: 20-OCT-2023 (strength, route of administration, and indication were not provided).  On 01-JUL-2023, healthcare worker reported that a patient developed injection site reaction after receiving PNEUMOVAX 23. The patient's arm was swollen and warm to the touch. No additional AEs were reported. No further information provided. No PQC. At the time of reporting, the patient was recovering from the event of Vaccination site warmth, Vaccination site swelling and Vaccination site reaction.  The action taken with PNEUMOVAX23 regarding events was reported as Not Applicable.  The causal relationship between events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: hives; swelling; This non-serious case was reported by a other health professional via sales rep and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUL-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: hives) and swelling (Verbatim: swelling). The outcome of the hives and swelling were not reported.   It was unknown if the reporter considered the hives and swelling to be related to Shingrix.     It was unknown if the company considered the hives and swelling to be related to Shingrix.   Additional Information: GSK receipt date: 3-Aug-2023 The patient was the spouse of reporter. The patient had received 1st dose of Shingrix 3 weeks ago and has had hives and swelling since. The physician recommended patient to receive vaccine because over 50 years old and has had significant adverse events related to the skin.  The patient was not going to get the 2nd dose. The reporter consented to follow-up.
Age: 71.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Chills, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: aching everywhere; nausea; fever; chills; Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   The patient's past medical history included spinal laminectomy (Laminectomy and fusion on L3,4,5 vertebrae).   On 31-JUL-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) and the 1st dose of Hepatitis B vaccine (intramuscular, left deltoid). On 31-JUL-2023, 6 hrs after receiving Shingrix and Hepatitis B vaccine, the patient experienced general body pain (Verbatim: aching everywhere), nausea (Verbatim: nausea), fever (Verbatim: fever), chills (Verbatim: chills) and pain in arm (Verbatim: Sore arm). The outcome of the general body pain, nausea, fever, chills and pain in arm were unknown.   It was unknown if the reporter considered the general body pain, nausea, fever, chills and pain in arm to be related to Shingrix and Hepatitis B vaccine.     It was unknown if the company considered the general body pain, nausea, fever, chills and pain in arm to be related to Shingrix and Hepatitis B vaccine.   Additional Information: Receipt date: 01-AUG-2023 The Consumer reported that he received his Shingrix and his Hepatitis B (unknown manufacturer) the day before reporting, both in the left deltoid. He had experienced arm pain that began about 4 hours after his vaccination, and chills, fever, nausea and general aches which started about 6 hours after the shot.
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Laboratory test abnormal, Platelet count decreased
Clinical narrative: autoimmune disease; low platelet count on the month on June; This serious case was reported by a pharmacist via call center representative and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31-MAY-2023, the patient received the 1st dose of Shingrix. In JUN-2023, less than 2 months after receiving Shingrix, the patient experienced platelets decreased (Verbatim: low platelet count on the month on June). On an unknown date, the patient experienced autoimmune disorder (Verbatim: autoimmune disease) (serious criteria GSK medically significant). The outcome of the autoimmune disorder and platelets decreased were unknown.   It was unknown if the reporter considered the autoimmune disorder and platelets decreased to be related to Shingrix.     It was unknown if the company considered the autoimmune disorder and platelets decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-AUG-2023 A pharmacist called to inform that a patient that received the 1st dose of Shingrix back and presented a low platelet count on the month of June. At the moment the pharmacist called they said the patient had stabilized.  However, also the pharmacist said that the patient had a possible diagnosis of an autoimmune disease.  The pharmacist was not able to say if the autoimmune disease was diagnosed before or after receiving the 1st dose of Shingrix.  Upon escalation to 2nd line, health care professional (HCP) stated they are unsure if patient had a prior history of low platelets prior to receiving first dose of Shingrix or if low platelets occurred following administration of the first dose of Shingrix. The HCP will follow up with more details if this occurred following vaccination with Shingrix. The case US2023104716 was found as duplicate of this case. All the information from the case US2023104716 was merged into this case. The case US2023104716 was deleted and this case stand as case of record for this patient.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got active zoster 6 weeks later; This non-serious case was reported by a physician via call center representative and described the occurrence of herpes zoster in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 weeks after receiving Shingrix, the patient experienced herpes zoster (Verbatim: got active zoster 6 weeks later). 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: 01-Aug-2023 Health care professional reported that a patient took his first Shingrix vaccine and got active zoster. The reporter reported that the guidance at that time was to give 2nd shingrix vaccine 10 plus months after active virus.  The reporter asked that the patient could now complete the shingrix course or did the patient have to start over and get 2 more shingrix vaccines.
Age: 82.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 82-year-old male patient who received HAB (Twinrix) (batch number 327E3, expiry date 14-MAY-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 1st September 2021).   On 19-MAY-2023, the patient received the 2nd dose of Twinrix. On 19-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received late). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-AUG-2023 The pharmacist reported that patient received the first dose of Twinrix then a late second dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. The reporter consented to follow up via mail The vaccine administration facility is the same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Potential administration in thigh; would like to administer in the thigh; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   On an unknown date, the patient received Shingrix (unknown thigh). On an unknown date, an unknown time after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error (Verbatim: Potential administration in thigh) and vaccine administered at inappropriate site (Verbatim: would like to administer in the thigh). The outcome of the circumstance or information capable of leading to medication error and vaccine administered at inappropriate site were unknown.   Additional Information: GSK receipt date: 01-AUG-2023 The pharmacist informed that a patient was not able to receive Shingrix due to a cancer (not specified) and that would like to administer in the thigh which led to circumstance or information capable of leading to medication error and vaccine administered at inappropriate site. The reporter did not consent to follow up.
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Overdose; Inappropriate schedule of vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-month-old male patient who received HBV (Engerix B adult) (batch number N73FA, expiry date 30-JAN-2023) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX-B PEDIATRIC).   On 14-DEC-2022, the patient received the 2nd dose of Engerix B adult (rt. vastus lateralis) 1 ml. On 14-DEC-2022, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Overdose) and adult product administered to child (Verbatim: Inappropriate schedule of vaccine). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 2-Aug-2023 Medical assistant called to inquired that how to proceed with Hepatitis B series. On 3rd May 2023, the patient's mom stated that the patient received 3 shots that day (3rd May 2023) and health care professional thought one might have been an Engerix pediatric dose but there was no documentation or record and was unknown if an Engerix dose was administered. Did not consent to follow-up. The pediatric patient inadvertently received an adult dose of Engerix-B, which led to overdose and adult product administered to child.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neoplasm malignant, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; got cancer in 2021; breakout of shingles earlier this year; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male 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. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination Failure) (serious criteria GSK medically significant), cancer (Verbatim: got cancer in 2021) (serious criteria GSK medically significant) and shingles (Verbatim: breakout of shingles earlier this year). The outcome of the vaccination failure, cancer and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, cancer and shingles to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure, cancer and shingles to be related to Shingrix. It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-AUG-2023 The patient self-reported this case. The reporter mentioned that the patient had a full course of Shingrix in 2020 and got cancer in 2021.  The doctor recommended that he would get Shingrix again. The patient had a breakout of shingles earlier this year. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives on both arms, a little on her neck, and some on neck, waist up; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUL-2023, the patient received the 1st dose of Shingrix (right arm). In AUG-2023, less than 2 months after receiving Shingrix, the patient experienced hives (Verbatim: hives on both arms, a little on her neck, and some on neck, waist up). The outcome of the hives was not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt date: 03-AUG-2023 A Reporter reported about herself she received her 1st dose of Shingrix in her right arm about 2 weeks ago on a Monday in July 2023 (no specific date provided), and reports that she woke up a day or 2 ago (no specific date provided), with hives on both arms, a little on her neck, and some on her back, and only on areas from her waist up. Patient did not have the Lot/Expiry information.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Not received 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2017).   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 received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 03-AUG-2023 The reporter is a friend of the patient who stated that her friend received first dose of Shingrix in 2017, and never got the second dose. According to reporter patient had intention of receiving second dose soon.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 0.92
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 13-month-old male patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On 15-JUN-2023, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt date: 3-AUG-2023 The reporter reported that the Havrix vaccines exposed to a low temperature of 31.5 degrees Fahrenheit on 15th June 2023 was administered between 15th June 2023 and 21st June 2023. Reporter did not have specific date of administration for each patient. The reporter reported that at the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The reporter reported that the administered Havrix vaccines exposed to a low temperature of 31.5 degrees Fahrenheit, which led to incorrect storage of drug. This case was 1 of 9 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023105928:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105927:same reporter US-GSK-US2023105926:same reporter US-GSK-US2023105923:same reporter US-GSK-US2023105921:same reporter US-GSK-US2023105918:same reporter US-GSK-US2023105917:same reporter
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Exposed to a low temperature of 31.5 degrees Fahrenheit; Patient born on Jun-2023 and received vaccine between 15 to 21st jun 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a neonate male patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On 15-JUN-2023, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Exposed to a low temperature of 31.5 degrees Fahrenheit). In JUN-2023, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient born on Jun-2023 and received vaccine between 15 to 21st jun 2023). The outcome of the incorrect storage of drug and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 03-AUG-2023 The reporter reported that the Havrix vaccine was exposed to a low temperature of 31.5 degrees Fahrenheit on 15th June 2023 and administered to the patient between 15th June 2023 and 21st June 2023. The reporter did not had specific date of administration. The reporter stated that at the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The Havrix vaccine temperature was exposed to 31.5 degrees Fahrenheit, which led to incorrect storage of drug. The patient received Havrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter did consent to follow up. This case was 1 of 9 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023105921:same reporter US-GSK-US2023105918:same reporter US-GSK-US2023105928:same reporter US-GSK-US2023105926:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105927:same reporter
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 13-month-old female patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt date: 3-AUG-2023 The reporter reported that the Havrix vaccines exposed to a low temperature of 31.5 degrees fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023. Reporter did not have specific date of administration for each patient. The reporter reported that at the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The reporter reported that the Havrix vaccines exposed to a low temperature of 31.5 degrees fahrenheit, which lead to incorrect storage of drug. The case had been link to US2023105916, US2023105928, US2023105927, US2023105925, US2023105923, US2023105921, US2023105918, US2023105917 reported by same reporter.; Sender's Comments:  US-GSK-US2023105916:same reporter US-GSK-US2023105928:same reporter US-GSK-US2023105927:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105923:same reporter US-GSK-US2023105921:same reporter US-GSK-US2023105918:same reporter US-GSK-US2023105917:same reporter
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Vaccine stored at lowtemperature of 31.5 degrees Fahrenheit and administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old male patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored at lowtemperature of 31.5 degrees Fahrenheit and administered). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 03-AUG-2023 Nurse reported that patient was administered with Havrix vaccine. On 15Jun2023 vaccine was exposed to a low temperature of 31.5 degrees Fahrenheit . The reporter was not sure on which date vaccine was administered.  According to reporter it was administered between 15Jun2023 and 21Jun2023. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. The patient was administered with vaccine which was stored at low temperature which led to, Incorrect storage of drug. The reporter consented to follow up. This is 1 of 8  linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2023105916:same reporter US-GSK-US2023105921:same reporter US-GSK-US2023105926:same reporter US-GSK-US2023105917:same reporter US-GSK-US2023105918:same reporter US-GSK-US2023105923:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105927:same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of Shingrix after the maximum interval of time has elapsed; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number b4999) for prophylaxis.   Previously administered products included Shingrix (On an unknown date received, first dose).   On 03-AUG-2023, the patient received the 2nd dose of Shingrix. On 03-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose of Shingrix after the maximum interval of time has elapsed). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 3-AUG-2023 The reporter called in to inquired about how to proceed in case a patient received a dose of Shingrix after the maximum interval of time had elapsed. The reporter requested to remain anonymous, provided partial information about product, patient and event and dropped the call. The vaccine administration facility was the same as primary reporter. The follow-up could not be possible as the as no contact details were available. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received error of third dose of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (primary series completed in 2019).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received error of third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 03-AUG-2023 The reporter reported that he or she had case where patient received error of third dose of Shingrix vaccine. The reporter reported that the patient received single dose now. The reporter asked a question that what were the studies done of patients receiving 3rd dose and recommendations. The follow-up could not be possible as the as no contact details were available. The reporter reported that the patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the 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 elderly male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (on 14th May 2022 received 1st dose with batch no 4EA77 and expiry date 11-SEP-2022.).   On an unknown date, the patient did not received the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 03-AUG-2023 A pharmacist reported that a patient received first dose of Engerix-B on 14May2022 and never received the second dose. At the time of reporting, no further doses had administered.  Till the time of reporting the patient had not received the second dose of Engerix-B, which led to incomplete course of vaccination. The VAERS details reported for 1st dose.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 13 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 4-Aug-2023 The pharmacist stated that the patient was at the pharmacy to get the 2nd dose at the time of the call. The exact date of first date was unknown as it was administered at a different facility. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 4JUN2023, Expiration date 30MAY2023; No adverse event; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4JUN2023, Expiration date 30MAY2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4JUN2023, Expiration date 30MAY2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4JUN2023, Expiration date 30MAY2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4JUN2023, Expiration date 30MAY2023).    Concomitant medication was not reported. Vial was initially stored in the refrigerator on 04-Jun-2023. Vial did not undergo any temperature excursions. Treatment medication was not reported.  This case was for the 42nd patient out of 50 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case (Patient 42)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-Jun-2023 after expiration date 30-May-2023; No adverse event; Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiration date 30-May-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiration date 30-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiration date 30-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiration date 30-May-2023).    This case contains information for patient 43 out of 50 patients as described by the reporter.  No concomitant medication information was reported.  It was reported that no adverse reactions had been reported by any patients.  The vial was initially stored in the refrigerator on 4-Jun-2023 and did not undergo any temperature excursion.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case (Patient 43)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-Jun-2023 after expiry on 30-May-2023; No adverse event; Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiry on 30-May-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiry on 30-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiry on 30-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiry on 30-May-2023).    This case contains information for patient 44 out of 50 patients as described by the reporter.  No concomitant medication information was reported.   It was reported that no adverse reactions had been reported by any patients.  The vial was initially stored in the refrigerator on 4-Jun-2023 and did not undergo any temperature excursion.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case (Patient 44)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions have been reported; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and NO ADVERSE EVENT (No adverse reactions have been reported) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reactions have been reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and NO ADVERSE EVENT (No adverse reactions have been reported) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reactions have been reported) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired).    No concomitant medication was reported.   It was reported that no adverse reactions have been reported by any patients.  On 04-Jun-2023, the vial was initially stored in the refrigerator and did not underwent any temperature excursions.  No treatment medication was reported.  This case is reported for patient 45 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023; She states that no adverse reactions have been reported by any patients; Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023).    Concomitant medications were not reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions.  Treatment information was not reported.  This case is reported for patient 46 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case