chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Discomfort, Herpes zoster, Incomplete course of vaccination
Clinical narrative: suspected vaccination failure; Shingles on her right torso; Rash with blisters; Rash with blisters; Shingles on her right torso; Soreness, achiness and pain at the injections site; Swelling at the injections site; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2021, the patient received the 2nd dose of Shingrix. On 30th July 2021, the patient received the 1st dose of Shingrix. On 30th July 2021, not applicable after receiving Shingrix and less than a day after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On 5th August 2021, the patient experienced shingles and blistery rash. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blistery rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and blistery rash were not recovered/not resolved and the outcome of the shingles, injection site pain, injection site swelling and blistery rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and blistery rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles, injection site pain, injection site swelling and blistery rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 24 May-2022 Reporter's Comments:  The case was reported by patient. She had her first dose of Shingrix and experienced soreness, achiness, swelling, and pain at the injections site. The patient stated that seven after her first dose she developed Shingles on her right torso in the form of a rash with blisters. The patient was currently experiencing her fourth outbreak of these same blisters and rash.  The reporter consented to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site swelling, Rash, Rash vesicular
Clinical narrative: suspected vaccination failure; Shingles on her right torso; Rash with blisters; Rash with blisters; Shingles on her right torso; Soreness, achiness and pain at the injections site; Swelling at the injections site; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2021, the patient received the 2nd dose of Shingrix. On 30th July 2021, the patient received the 1st dose of Shingrix. On 30th July 2021, not applicable after receiving Shingrix and less than a day after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On 5th August 2021, the patient experienced shingles and blistery rash. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blistery rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and blistery rash were not recovered/not resolved and the outcome of the shingles, injection site pain, injection site swelling and blistery rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and blistery rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles, injection site pain, injection site swelling and blistery rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 24 May-2022 Reporter's Comments:  The case was reported by patient. She had her first dose of Shingrix and experienced soreness, achiness, swelling, and pain at the injections site. The patient stated that seven after her first dose she developed Shingles on her right torso in the form of a rash with blisters. The patient was currently experiencing her fourth outbreak of these same blisters and rash.  The reporter consented to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles on her right torso; Rash with blisters; Rash with blisters; Shingles on her right torso; Soreness, achiness and pain at the injections site; Swelling at the injections site; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2021, the patient received the 2nd dose of Shingrix. On 30th July 2021, the patient received the 1st dose of Shingrix. On 30th July 2021, not applicable after receiving Shingrix and less than a day after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On 5th August 2021, the patient experienced shingles and blistery rash. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blistery rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and blistery rash were not recovered/not resolved and the outcome of the shingles, injection site pain, injection site swelling and blistery rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and blistery rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles, injection site pain, injection site swelling and blistery rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 24 May-2022 Reporter's Comments:  The case was reported by patient. She had her first dose of Shingrix and experienced soreness, achiness, swelling, and pain at the injections site. The patient stated that seven after her first dose she developed Shingles on her right torso in the form of a rash with blisters. The patient was currently experiencing her fourth outbreak of these same blisters and rash.  The reporter consented to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose administered after manufacturer date of expiry; Received expired 2nd booster after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. it was reported that 15 dose each red cap vial. Date the vial was initially stored in the refrigerator: N/A On 25MAY2022 was moved from Freezer to Room Temperature. The vial did not undergo any temperature excursions. No treatment information was reported.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after manufacturer date of expiry; Received expired 2nd booster after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. it was reported that 15 dose each red cap vial. Date the vial was initially stored in the refrigerator: N/A On 25MAY2022 was moved from Freezer to Room Temperature. The vial did not undergo any temperature excursions. No treatment information was reported.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED AFTER 6 HOURS OF VIAL PUNCTURE; This spontaneous report received from a physician concerned a 33 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 08-SEP-2022) .5 ml, administered on 14-FEB-2022 for prophylactic vaccination. Age at time of vaccination 33 years old. No concomitant medications were reported. On 14-FEB-2022, the patient experienced vaccine administered after 6 hours of vial puncture. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after 6 hours of vial puncture and incorrect product storage was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000233203. This case, from the same reporter is linked to 20220558497, 20220558436, 20220558469, 20220558482, 20220558498 and 20220558436.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED AFTER 6 HOURS OF VIAL PUNCTURE; This spontaneous report received from a physician concerned a 33 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 08-SEP-2022) .5 ml, administered on 14-FEB-2022 for prophylactic vaccination. Age at time of vaccination 33 years old. No concomitant medications were reported. On 14-FEB-2022, the patient experienced vaccine administered after 6 hours of vial puncture. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after 6 hours of vial puncture and incorrect product storage was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000233203. This case, from the same reporter is linked to 20220558497, 20220558436, 20220558469, 20220558482, 20220558498 and 20220558436.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling drunk
Clinical narrative: The patient complains of a sore left arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The patient complains of a sore left arm.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 058E21A, 040A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced VACCINATION SITE PAIN (The patient complains of a sore left arm.). At the time of the report, VACCINATION SITE PAIN (The patient complains of a sore left arm.) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2022-576700, MOD-2022-576746, MOD-2022-576759 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: The patient complains of a sore left arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The patient complains of a sore left arm.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 058E21A, 040A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced VACCINATION SITE PAIN (The patient complains of a sore left arm.). At the time of the report, VACCINATION SITE PAIN (The patient complains of a sore left arm.) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2022-576700, MOD-2022-576746, MOD-2022-576759 (Patient Link).
Age: 0.08
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No additional AE details; Customer calling for TE evaluation on frozen products states that 7 vaccines stored outside of recommended range were administered to patients.; inappropriate age at vaccine administration; This spontaneous report was received from an administrator and referred to a 7-week-old male patient. Pertinent medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent.  On 12-APR-2022, the patient was vaccinated with the improperly stored (stored outside of recommended range) measles, mumps, rubella and varicella (oka-merck) virus vaccine (live recombinant human albumin (rHA)) (PROQUAD) (lot #U039258, expiration date: 09-JUN-2023) for prophylaxis (strength, dose, and route of administration were not provided) (product storage error and product administered to patient of inappropriate age).  It was reported that the suspect vaccine was exposed to a temperature of 6 Fahrenheit (F) up to 14 F (7.9 F) for a time frame of 4 hours, 8 minutes, and 0 second. There were no previous temperature excursions. No digital data logger was reported.  No additional adverse event (AE) details was provided (no adverse event).   This is one of the several cases reported by the same reporter.; Sender's Comments:  US-009507513-2205USA001205: US-009507513-2205USA001061: US-009507513-2205USA000973:02158490 US-009507513-2205USA001043: US-009507513-205USA001272: US-009507513-2205USA001271:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product use issue
Clinical narrative: An adult patient received two pediatric doses of VAQTA; no adverse event; This spontaneous report has been received from a Registered nurse concerning an adult patient of unknown gender.  The patient's concurrent conditions, medical history, historical drugs or concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with two pediatric doses of hepatitis a vaccine, inactivated (VAQTA) (anatomical location, route of administration, lot#, and expiration date were not reported) for prophylaxis. On an unknown date, two additional pediatric doses were administered to the patient as second dose (Product use issue).  No additional adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; administration of an expired VAQTA; This spontaneous report was received from a pharmacist and referred to a patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant medication were not provided.   On 06-MAY-2022, the patient was vaccinated with 1 dose of expired Hepatitis A Vaccine, Inactivated (VAQTA) (strength, and route were not reported; valid lot# U003450 with expiration date: 02-MAY-2022) for prophylaxis (expired product administered). The vaccine was stored within the recommended storage range until the administration. No additional adverse event reported (no adverse event).  This case is non-valid due to the lack of patient's identifiers.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; improperly stored vaccines were administered; This spontaneous report was received from an other type of reporter and refers to a 4-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 12-APR-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #T026960, expiration date: 17-MAR-2023 (strength, site and route of administration were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U005994, expiration date: 10-SEP-2022, administered orally (strength was not provided), both for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  On an unknown date, before the vaccination, the vaccines underwent temperature excursion at 67.3 Fahrenheit degrees (F) for 1 hour and 10 minutes. No previous temperature excursions were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's and no PQC's were reported; an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report has been received from a registered nurse concerning a patient of unreported age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, or allergies, and concomitant medications were not provided.  On 13-MAY-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, vial (valid lot number U024220 (also reported as U024229) [expiration date 04-AUG-2023]) for prophylaxis (reported as use as directed to prevent varicella infection), after a temperature excursion of 32.9 degrees Fahrenheit (F) for 24 hours (h) 30 minutes (min) and 0 seconds (sec) (product storage error) (dose, dose number, vaccination scheme frequency, route, and anatomical location of vaccination were not provided). No previous temperature excursion was reported. No additional adverse events (AE) were reported.  This is one of some cases from same reporter.; Sender's Comments:  US-009507513-2205USA004149:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; patient was accidently administered an expired dose of MMR II; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 13-MAY-2022 the patient was vaccinated with a expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) rHA (Dose frequency: once, lot # T016195, expiration date: 11-MAY-2022, dose, strength and route were not provided) for prophylaxis (expired product administered). Product had no prior temperature excursions. No further information provided. No additional adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Deafness, Herpes zoster, Post herpetic neuralgia
Clinical narrative: hearing loss; vision loss; post herpetic neuralgia; multiple outbreaks of herpes zoster; Information has been received from a lawyer, regarding a case in litigation concerning a patient of an unknown age and gender. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster, post herpetic neuralgia, hearing loss and vision loss. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. As a result of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) conduct, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.The outcome of the events was considered to be not recovered. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was determined to be related.  Upon internal review, the events of hearing loss and vision loss were considered to be medically significant. All events were considered to be disabling by a reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX has been administered with an inappropiate storage; No additional AE details; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On an unknown date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX)  for prophylaxis (lot # U039949 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 16-DEC-2023) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were -14° Celsius (C) up to -10°C for 2 hours and 5 minutes and -10°C up to 8°C for 1 hour and 25 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines experienced a previous temperature excursion of -14°C up to -10°C for 0 hours 50 minutes.  No adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX has been administered to a total of 13 patients. Temperature -14°C up to-10°C for 2 hours 5 minutes 0 seconds ; -10°C up to 8°C (-0.4C) for 1 hour 25 minutes 0 seconds; No additional AE details; This spontaneous report was received from a costumer referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On an unknown date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX)  for prophylaxis (lot # U039949 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 16-DEC-2023) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were -14° Celsius (C) up to -10°C for 2 hours and 5 minutes and -10°C up to 8°C for 1 hour and 25 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines experienced a previous temperature excursion of -14°C up to -10°C for 0 hours 50 minutes.  No adverse event reported.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a medical assistant and an other non-health care professional referring to a 1-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. No illness at time of vaccination nor vaccine within 4 weeks prior to vaccination date was reported.  On 23-MAR-2022, the temperature excursion occurred of varicella virus vaccine live (oka/merck) (VARIVAX). The storage temperature was -14 degree Celsius up to -10 degree Celsius for 3 hours and -10 degree Celsius up to 8 degree Celsius for 1 hour 30 minutes. There was no previous temperature excursion. The temperature excursion occurred as a result of a reading from a digital data logger. On 04-APR-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection by a healthcare professional for prophylaxis (subcutaneous, lot #U025790, expiration date: 19-AUG-2023; strength and dose were not provided) (product storage error). No additional adverse event (no adverse event) was reported. After administration, the reporter contacted company and verified the viability of vaccine. The vaccine was not available for return or evaluation because it was given to the patient.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA008004: US-009507513-2204USA009330:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; VARIVAX administered after temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 21-APR-2022, improperly stored, varicella virus vaccine live (oka/merck) (VARIVAX) 0,5 milliliter, lot #U019906, expiration date: 24-JUN-2023, subcutaneously was administered for prophylaxis. The vaccine experienced a temperature excursion of 6.8 degree Fahrenheit for 1 hour and 36 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; one dose of improperly stored MMR II was administered to a patient on 24May2022; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about patient's pertinent medical history, concomitant medications, concurrent conditions and drug reactions/ allergies was not provided.  On 24-MAY-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin, rHA) (M-M-R II), lot number: U007686, expiration date: 09-MAR-2023 (dose, dose number and route of administration was not provided) for prophylaxis (product storage error). No additional adverse events (AEs) were reported (no adverse event). No product quality complaint (PQC).  The administered dose of the vaccine experienced a temperature excursion of 13.4 degrees Celsius for 8 hours. There were no previous reported temperature excursions. It was unknown if a digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported.; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information about patient's pertinent medical history, concomitant medications, concurrent conditions and drug reactions/ allergies was not provided.  On 24-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), dose of 0.5 mL, administered subcutaneously, lot number: U019906, expiration date: 24-JUN-2023 (dose number was not provided) for prophylaxis (product storage error). No additional adverse events (AEs) or product quality complaint (PQC) was reported (no adverse event).  The administered dose of the vaccine experienced temperature excursion of 6.8 degrees Fahrenheit (F) for 1 hour and 36 minutes and 6.0 F for 36 minutes. There were no previous reported temperature excursions. It was unknown if a digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first and second dose four weeks apart; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 24-MAY-2022  Reporter's Comment: The reporter stated that, his/her several in laws received first and second dose of Shingrix just four weeks apart.  The reporter simply reported themselves and several of their family members was receiving the first and second dose four weeks apart instead of the recommended minimum of 2 months for the second dose, after receipt of the first dose. The reporter did not consent to follow-up. Additional supportive information: The patients received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of vaccination schedule. This case had been linked with case US2022083417, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022083417:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Loss of consciousness
Clinical narrative: Found myself kind of like nodding off, passing out; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th May 2022, the patient received the 1st dose of Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient found himself/herself kind of like nodding off, passing out. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Hernia
Clinical narrative: hernia; This case was reported by a consumer via call center representative and described the occurrence of hernia in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hernia. On an unknown date, the outcome of the hernia was not recovered/not resolved.   It was unknown if the reporter considered the hernia to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-MAY-2022 Reporter's comment: The patient reported this case. The patient was 76 years old and was in construction all his life and never had a hernia. The patient got a Shingrix shots, two of them and now had a large hernia in two places. The patient's doctor said it was a hernia. The patient asked if these shots could do this.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: painful, sore and achy; felt sick; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and feeling unwell. On an unknown date, the outcome of the pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the pain and feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient reported that just be prepared the Shingles shot was painful and felt sick, sore and achy for days.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel generally crappy; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th May 2022, the patient received the 1st dose of Shingles vaccine. On 25th May 2022, 1 days after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was not recovered/not resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient got Shingles shot on the day before the reporting. The patient felt generally crappy on the date of reporting. The patient said that if it kept he or she away from getting shingles, he or she would deal with feeling crappy for a day or two.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Today i just can´t get going; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 25th May 2022, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 25-MAY-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. Today (on the date of reporting) the patient could not get going. The patient asked could this be a possible side effect of the vaccine shot. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Protein total increased
Clinical narrative: those lovely shots killed my daddy; shed that spike protein; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included covid-19 (Family History) (the patient's son-in-law had covid-19) and shingles (Family History) (the patient's daughter had shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and protein total increased. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the protein total increased was unknown. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be related to Shingles vaccine. It was unknown if the reporter considered the protein total increased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comment: This case was reported by patient's daughter via interactive digital media. The patient took the jabs (Shingles vaccine) (though the reporter begged him not to) and he shed that spike protein and suddenly reporter's husband had Covid and reporter had shingles. The reporter stated that, if that was not enough, those lovely shots killed her daddy (patient). The reporter further stated that, all these little birds were chirping source, source would never believe they had been lied too and fooled. The doctors and so many others were kept ringing the alarm, but they would not listen. Additional Supportive Information: The follow up would not possible as no contact details were available. Note: As the information was not clear. Hence, all the information was retained, and case kept valid.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the vaccine and still got shingles/ Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingles vaccine and still experienced shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; was miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: This case was reported by a patient's cousin via interactive digital media. The patient got the shingles after she got the shingles vaccine and never had shingles before and she was miserable. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My husband suffered with shingles for about four years had taken the shots/suspected vaccination failure; My husband suffered with shingles for about four years; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comment: This case was reported by patient's wife via interactive digital media. The patient had taken the shingles shots. The patient suffered with shingles for about four years. The patient's shingles was worst cases any doctor had ever seen. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had Shingles 7 times since I got vaccine/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles 30 times in the last 8 years from reporting date).   In April 2021, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got the shingles vaccine in April a year ago.  The patient got 7 out of 30 times shingles since he/she had been vaccinated. The patient stated that, it was horrible. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter