chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; administered an expired dose of GARDASIL 9; This spontaneous report was received from the patient's mother concerning a 12-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified day in June 2022, the patient was vaccinated with a possibly expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, injection anatomical location, route of administration lot # and expiration date were not provided) (Expired product administered). The reported stated that the dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered was expired by 3 months, and when she questioned the healthcare professional (HCP) about it, the HCP provided a different lot number that was no expired. The reporter was concerned about the HCP not being truthful about which lot was administered. No adverse events were reported (No adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired dose of VAQTA was administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-FEB-2023, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, administered intramuscular, lot #U013969, expiration date 06-FEB-2023 (anatomical location was not reported) for prophylaxis (expired product administered). No additional adverse events were reported.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Nurse reporting an AE for VARIVAX. Caller stated after receiving the vaccine, the patient disclosed she was 5 months pregnant. No symptomatic AE reported. Caller gave permission to contact, did not provide further information during MNSC call. No PQC; No symptomatic AE reported; Caller stated after receiving the vaccine, the patient disclosed she was 5 months pregnant.; This spontaneous prospective report was received from a nurse and refers to a pregnant 24-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown date, the patient became pregnant. The last menstrual period (LMP) was in approximately 2022 and pregnancy gestation date was reported as 5 months.  On 17-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # W022605, expiration date 17-JUL-2024, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis (immunization). The reported stated that after received the vaccine, the patient disclosed she was 5 months pregnant (vaccine exposure during pregnancy,contraindicated product administered). No symptomatic adverse event reported (no adverse event). The pregnancy outcome was pending and fetal outcome was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles within days of their shots / Suspected vaccination failure; Got shingles within days of their shots this year; 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: 14-FEB-2023 Reporter's Comments: The case was reported by a patient's family member interactive digital media. The reporter reported that then avoid the shingles shot. The patient (two people in the reporter's family) got shingles within days of their shots this year. This case is linked with US2023AMR025323 same reporter for different patient. 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 test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR025323:Same reporter
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles left side of head, face, not pleasant; 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: 15-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shot when he or she was 60. After that, the patient experienced shingles on left side of his/her head, face that missed eye. The patient could not believe it and not the most pleasant things to deal with. Additional Supportive Information: The follow up would not possible, as no contact, details were available. 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.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Weird taste; This case was reported by a pharmacist via call center representative and described the occurrence of taste peculiar in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number Xy22f, expiry date unknown) for prophylaxis.   Concomitant products included alprazolam.   On 3rd February 2023, the patient received the 1st dose of Shingrix. On 3rd February 2023, less than a day after receiving Shingrix, the patient experienced taste peculiar. On an unknown date, the outcome of the taste peculiar was not recovered/not resolved.   It was unknown if the reporter considered the taste peculiar to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comment: The reporter called to inform that earlier that day, a patient began to had a weird taste on the mouth after receiving the Shingrix.  The symptoms were not treated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: This case was identified as duplicate of the case US2023017399. All future correspondence was submitted to US2023017283.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tired out; This case was reported by a consumer and described the occurrence of tired out in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes and blood pressure high. Concomitant products included metformin and metoprolol.   On 7th February 2023, the patient received Shingrix .5 ml. On 9th February 2023, 2 days after receiving Shingrix, the patient experienced tired out. On 10th February 2023, the outcome of the tired out was recovered/resolved.   It was unknown if the reporter considered the tired out to be related to Shingrix.     Additional Information: GSK Receipt date: 11-Feb-2023. Reporter's Comment:  This report was submitted via the online direct entry reporting system. The symptoms were not treated. The reporter did not consent to follow-up. Note: No overdose was considered as an event as no medication error reported in the case clarification was raised for the same.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Sick all night; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got shingles shot and was sick all night.  They said the second shingles vax was worse.  Not looking forward to that, but a couple sick days was better than an outbreak of shingles. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurts; 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.   In December 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR024175   Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that the physician recommended to receive Shingles vaccine for all the peoples 50 years of age and older. There was two doses and we are protected against that painful disease. The patient stated that he/she received first dose of shingles vaccine in December 2022 and he/she shall receive 2nd dose in March 2022. The patient asked about vaccine insurance covers and it was hurts like any vaccine. Additional supportive information: Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR024175:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm hurt so much; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccines with an associated reaction of pain in extremity (received Covid vaccines on an unknown date and had arm hurt ).   In February 2023, the patient received Shingles vaccine. In February 2023, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-FEB-2023 Reporter's Comments: The patient took the vaccine this week and his/her arm hurt so much more with the Covid vaccines, but the patient had to do that for his/her health on the day of reporting in this world. The patient did not know what disease he/she was going to die from, there's so much disease in this world. Additional supportive information: The follow-up could not be possible as no contact details were available. As per intake comment vaccine seems to be typo error therefore it was coded as Covid vaccine conservatively as Historical drug considering that the patient had received the vaccine in past and had arm hurt.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comments: This case was reported by a patient's wife interactive digital media. The patient reported avoided shingles shot. Two of people got shingles within days of their shots this year. Additional Supportive Information:  This case is linked with US2023AMR025312 same reporter different patient. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR025312:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient accidentally received third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first two doses of Shingrix were administered back in 2018).   On 5th February 2023, the patient received the 3rd dose of Shingrix. On 5th February 2023, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Linked case(s) involving the same patient:  US2023023345   Additional Information: GSK Receipt date: 13-Feb-2023. Reporter's Comment: The reporter was pharmacy manager. Caller reported patient accidentally received third dose of Shingrix. Caller did not have patient demos at time of call, as they were not in the pharmacy. Pharmacist called to inquire for any information on a third dose of Shingrix. Reporter was unable to provide any additional information. The reporter consented to follow-up. Additional Supportive Information: Patient accidentally received third dose of Shingrix, which led to extra dose administered. Case US2023023345 was identified as duplicate case of US2023023336.All the future correspondence will be added to case US2023023336 (case of record).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 1st February 2023, the patient received Havrix. On 1st February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 13-Feb-2023 Reporter's Comment: Reporter stated administration of an expired dose of Havirix to a patient. Pharmacist declined to provide any patient demographics. The reporter consented to follow-up. Additional Supportive Information: The patient received an expired Havrix vaccine, which led to expired vaccine used.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental overdose
Clinical narrative: Partial dose received, around half of dose was lost; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 7KR4T, expiry date 21st May 2024) for prophylaxis.   On 13th February 2023, the patient received the 2nd dose of Shingrix. On 13th February 2023, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's comments: The pharmacist stated that, a nurse had reported to her that, during administration of a Shingrix vaccine, there was a malfunction with the needle used and the patient only received a partial dose.  The nurse had estimated it to be around half of the dose was lost.  At the time of reporting, the dose had not been repeated.  The vaccine administration facility was the same as primary reporter. No exposure was reported. The reporter had consented to follow-up. Additional supportive information: There was a malfunction with the needle used and the patient only received a partial dose, which had led to accidental underdose.
Age: 31.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired dose was given to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th February 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 13th February 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's Comment: The reporter was medical assistant. The reporter called to report that an expired dose of Twinrix was given to a patient and provided information about vaccines and patient. Information was read and reporter agreed to receive it by e-mail. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter called to report that an expired dose of Twinrix was given to a patient, which led to expired vaccine used.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only the liquid portion with lyophilized powder.; Received only the liquid portion with lyophilized powder.; This case was reported by a physician via sales rep and described the occurrence of inappropriate reconstitution technique in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 13-Feb-2023. Reporter's Comment: Patient received only the liquid portion of Menveo booster dose without reconstitution with lyophilized powder. Reporter asked should the child be re dosed with a completely new dose. Reporter asked about the spacing be between the incorrect dose and the redoes and what should be done with the remaining powder vial of Men A. No other information provided (date of vaccination, lot number, expiration date, patients identifiers). The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: Patient received only the portion of Menveo without reconstitution, which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 50 YO received Pediatric dose; 50 YO received Pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 7th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th February 2023, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 10th February 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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: 14-FEB-2023 Reporter's comment: The pharmacist called today and reported that a pediatric dose of Engerix-B was administered to an adult patient. The patient´s initials were asked but information was declined because it was not available. The reporter consent to follow up. Additional supportive information: The patient was given pediatric dose of Engerix-B as per the patient's age at time of vaccination, which led to underdose and adult use of a child product.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Condition aggravated, Discomfort, Fatigue
Clinical narrative: History of RA, worsened after Shingrix; Sore Arm; Swollen Arm; Arm hard; Arm warm to touch; Nauseated; Weak; Tired; Pain from waist up, it hurt all the time/pain; feels like I've been burnt; History of fibromyalgia, worsened after Shingrix; pressure from front to back; Tenderness; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis aggravated in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia, rheumatoid arthritis, osteoarthritis and abscess.   On 2nd February 2023, the patient received the 1st dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), pain in arm, swelling arm, induration, skin warm, nausea, weakness, tiredness, pain, burning sensation, fibromyalgia worsened, sensation of pressure and tenderness. On an unknown date, the outcome of the rheumatoid arthritis aggravated, pain in arm, swelling arm, induration, skin warm, nausea, weakness, tiredness, pain, burning sensation, fibromyalgia worsened, sensation of pressure and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the rheumatoid arthritis aggravated, pain in arm, swelling arm, induration, skin warm, nausea, weakness, tiredness, pain, burning sensation, fibromyalgia worsened, sensation of pressure and tenderness to be related to Shingrix.     Additional Information: GSK receipt date: 14-FEB-2023 Reporter's comment:  The patient reported that pain 3 days after 1st Shingrix vaccines, arm was really sore, swollen, hard, warm to the touch, nauseated, weak, tired for 3 days.  The reporter said pain from waist up that feels like was burnt. She had Rheumatoid Arthritis, Fibromyalgia, Osteoarthritis. The patient said fibromyalgia and Rheumatoid arthritis was gotten worse after Shingrix vaccine  This was been going on for a week and a few days.  She was to the emergency room 3 times.  The patient hurt all the time.  She had pressure from front to back, the doctors were ruled out kidney problems or diverticulitis. The patient was currently on antibiotics for an abscess that preceded the Shingrix vaccine.  The patient reported the symptoms were 24/7 and was not resolved.  Symptoms have persisted for over a week.  The tenderness did not go away. The reporter was consented to follow up. Additional Supportive Information: Concomitant medication antibiotics was only retained in narrative, as the ingredient was NOS which leads to report failure. Note: The event outcome was captured as not recovered as stated Symptoms have persisted for over a week.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fibromyalgia, Induration, Nausea, Pain, Pain in extremity
Clinical narrative: History of RA, worsened after Shingrix; Sore Arm; Swollen Arm; Arm hard; Arm warm to touch; Nauseated; Weak; Tired; Pain from waist up, it hurt all the time/pain; feels like I've been burnt; History of fibromyalgia, worsened after Shingrix; pressure from front to back; Tenderness; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis aggravated in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia, rheumatoid arthritis, osteoarthritis and abscess.   On 2nd February 2023, the patient received the 1st dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), pain in arm, swelling arm, induration, skin warm, nausea, weakness, tiredness, pain, burning sensation, fibromyalgia worsened, sensation of pressure and tenderness. On an unknown date, the outcome of the rheumatoid arthritis aggravated, pain in arm, swelling arm, induration, skin warm, nausea, weakness, tiredness, pain, burning sensation, fibromyalgia worsened, sensation of pressure and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the rheumatoid arthritis aggravated, pain in arm, swelling arm, induration, skin warm, nausea, weakness, tiredness, pain, burning sensation, fibromyalgia worsened, sensation of pressure and tenderness to be related to Shingrix.     Additional Information: GSK receipt date: 14-FEB-2023 Reporter's comment:  The patient reported that pain 3 days after 1st Shingrix vaccines, arm was really sore, swollen, hard, warm to the touch, nauseated, weak, tired for 3 days.  The reporter said pain from waist up that feels like was burnt. She had Rheumatoid Arthritis, Fibromyalgia, Osteoarthritis. The patient said fibromyalgia and Rheumatoid arthritis was gotten worse after Shingrix vaccine  This was been going on for a week and a few days.  She was to the emergency room 3 times.  The patient hurt all the time.  She had pressure from front to back, the doctors were ruled out kidney problems or diverticulitis. The patient was currently on antibiotics for an abscess that preceded the Shingrix vaccine.  The patient reported the symptoms were 24/7 and was not resolved.  Symptoms have persisted for over a week.  The tenderness did not go away. The reporter was consented to follow up. Additional Supportive Information: Concomitant medication antibiotics was only retained in narrative, as the ingredient was NOS which leads to report failure. Note: The event outcome was captured as not recovered as stated Symptoms have persisted for over a week.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rheumatoid arthritis, Skin warm, Tenderness
Clinical narrative: History of RA, worsened after Shingrix; Sore Arm; Swollen Arm; Arm hard; Arm warm to touch; Nauseated; Weak; Tired; Pain from waist up, it hurt all the time/pain; feels like I've been burnt; History of fibromyalgia, worsened after Shingrix; pressure from front to back; Tenderness; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis aggravated in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia, rheumatoid arthritis, osteoarthritis and abscess.   On 2nd February 2023, the patient received the 1st dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), pain in arm, swelling arm, induration, skin warm, nausea, weakness, tiredness, pain, burning sensation, fibromyalgia worsened, sensation of pressure and tenderness. On an unknown date, the outcome of the rheumatoid arthritis aggravated, pain in arm, swelling arm, induration, skin warm, nausea, weakness, tiredness, pain, burning sensation, fibromyalgia worsened, sensation of pressure and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the rheumatoid arthritis aggravated, pain in arm, swelling arm, induration, skin warm, nausea, weakness, tiredness, pain, burning sensation, fibromyalgia worsened, sensation of pressure and tenderness to be related to Shingrix.     Additional Information: GSK receipt date: 14-FEB-2023 Reporter's comment:  The patient reported that pain 3 days after 1st Shingrix vaccines, arm was really sore, swollen, hard, warm to the touch, nauseated, weak, tired for 3 days.  The reporter said pain from waist up that feels like was burnt. She had Rheumatoid Arthritis, Fibromyalgia, Osteoarthritis. The patient said fibromyalgia and Rheumatoid arthritis was gotten worse after Shingrix vaccine  This was been going on for a week and a few days.  She was to the emergency room 3 times.  The patient hurt all the time.  She had pressure from front to back, the doctors were ruled out kidney problems or diverticulitis. The patient was currently on antibiotics for an abscess that preceded the Shingrix vaccine.  The patient reported the symptoms were 24/7 and was not resolved.  Symptoms have persisted for over a week.  The tenderness did not go away. The reporter was consented to follow up. Additional Supportive Information: Concomitant medication antibiotics was only retained in narrative, as the ingredient was NOS which leads to report failure. Note: The event outcome was captured as not recovered as stated Symptoms have persisted for over a week.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 30th January 2023) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comment: A reporter called to ask for information about the administration of an expired Havrix dose to a patient. The reporter asked for safety information. The reporter did not provide patient and vaccine (lot number) information. The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered with expired dose of Havrix, which led to expired vaccine used.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles after receiving both Shingrix/Suspected vaccination failure; Shingles 1st outbreak/the second case of shingles was diagnosed yesterday on 13-Feb-2023; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 23rd June 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 14-Feb-2023 Reporter's Comments: The reporter reported two cases of shingles in a patient who came to their clinic.  The reporter reported that the patient said she had a case of shingles after receiving both Shingrix vaccines in unknown deltoid, but did not know the date of the first outbreak of shingles.  On 13th February 2023, the patient was diagnosed with second case of shingles, by her supervising health care professional.  The shingles was on the right side of the patients back. The reporter consented to follow up.  Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 18Sep2021, 2nd not yet; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18 September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-Feb-2023 Reporter's comment:  The case was reported by the physician. The physician reported that the patient received 1st dose on 18th September 2021 and has not received a second dose. Additional supportive information: Till the time of reporting the patient did not received the 2nd dose of vaccine which led to incomplete course of vaccination. Reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose in 2019).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 15-Feb-2023. Reporter's Comment: In 2023, patient received 3rd dose of Shingrix.  The pharmacist declined to provide patients date of birth but stated the patient was 81 years old. The pharmacist did not have vaccination dates or further details regarding the vaccine. The reporter did not consent to follow-up. Additional Supportive Information: Patient received a 3rd dose of Shingrix, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Chest pain, Pain in extremity, Pericarditis
Clinical narrative: Pericarditis; Chest pains, Soreness in chest; Soreness in  left arm; This case was reported by a nurse via sales rep and described the occurrence of pericarditis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced pericarditis (serious criteria GSK medically significant), chest pain and pain in arm. On an unknown date, the outcome of the pericarditis, chest pain and pain in arm were unknown.   It was unknown if the reporter considered the pericarditis, chest pain and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's comments: The nurse had stated that patient got Shingrix shot at the pharmacy.  A few weeks after receiving the Shingrix shot the patient experienced pericarditis, chest pains and soreness in chest and left arm. No other information was provided to the representative. The reporter had consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shot 1 May2022, hasnt received the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose intramuscularly into unknown arm on 10th May 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The case was self reported by the patient. The patient had yet to receive the second dose of Shingrix. Failed to ask the reporter if he had a record of the lot number he received. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 66.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 66-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 16th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-FEB-2023 Reporter's Comment: The licensed practical nurse reported that the they inadvertently administered an expired dose of Havrix yesterday. The reporter asked what to look for and asked should we revaccinate. The reporter did not consent to follow up. Additional Supportive Information: The use of Havrix, which was already expired on 30th January 2023, which led to expired vaccine used.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA658A, expiry date 31st January 2023) for prophylaxis.   On 16th February 2023, the patient received Menveo. On 16th February 2023, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-FEB-2023 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received an expired dose of Menveo vaccine. The reporter did consent to follow up via email. Additional supportive information: The patient received a Menveo which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEAD; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in MAR-2021 for covid-19 prophylaxis The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. It was reported as "dead following J and J Covid vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20230244421.; Sender's Comments: V0: 20230242008-Dead. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; HCP reported that patient received the vaccines on 21-Dec-2022 and then following that the vaccines were marked not to use.; Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 21-Dec-2022 and then following that the vaccines were marked not to use.) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, 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 15-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.). On 21-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 21-Dec-2022 and then following that the vaccines were marked not to use.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 21-Dec-2022 and then following that the vaccines were marked not to use.) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.) and POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 21-Dec-2022 and then following that the vaccines were marked not to use.).    No concomitant information was reported. It was reported that first time excursion started on 15-Dec-2022. It was unknown that patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine and also no reports of side effects had been reported to them. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; HCP reported that patient received the vaccine on 20-Dec-2022 and then following that the vaccine was marked not to use.; Excursion took place 15Dec2022 through 27Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccine on 20-Dec-2022 and then following that the vaccine was marked not to use.) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2022, 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. In December 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022). On 20-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccine on 20-Dec-2022 and then following that the vaccine was marked not to use.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccine on 20-Dec-2022 and then following that the vaccine was marked not to use.) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022) and POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccine on 20-Dec-2022 and then following that the vaccine was marked not to use.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was unknown that patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine. It was reported that first time excursion started on 15-Dec-2022 and HCP reported that they had given 16 doses of the vaccines between the 15-Dec-2022 and the 21-Dec-2022 and then following that the vaccines were marked not to use and also no reports of side effects had been reported to them. No treatment information was provided.