chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy, still has it, 2 months; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a male 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 bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter's friend got his 1st one and ended up with bell's palsy and still had it, about 2 months now. It did not seem to want to leave. The reporter asked that what did that tell you. The follow-up could not be possible as no contact details were available.
Age: 16.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gave a 16 year-old Kinrix instead of boostrix; Gave a 16 year-old Kinrix instead of boostrix; This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 16-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 details were reported as follows: HCP reported via email inquiry that employees in his/her clinic gave a dose of Kinrix instead of boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter wanted to know how soon the patient could receive the ordered dose of Boostrix. No adverse events submitted. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR262207:Same reporter. Pt 2 - 17y/o US-GLAXOSMITHKLINE-US2021263815:FU1 - deleted
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine, Shingles vaccine and Shingles vaccine. In January 2021, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pruritus and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown and the outcome of the pruritus was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had a Shingles shot and 2 booster shots over the years, which led to extra dose administered. The patient still got shingles on left arm and hand in January 2021 and still had itching. The patient stated that, it was a miserable disease. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the time to onset for shingles and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. In December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than a week after receiving Shingrix, 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 Shingrix. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter reported that just got his/her shot on friday till the time of reporting and that thing hurted so bad.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2 Shingles shots and had shingles about 4 years ago. The patient stated they were not nice. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: shingles, had shot, still got them./suspected vaccination failure; debilitating; itching; burning; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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), shingles, weakness, pruritus and burning sensation. On an unknown date, the outcome of the vaccination failure, weakness, pruritus and burning sensation were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, weakness, pruritus and burning sensation to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had been fighting the shingles for 2 months.  It was very debilitating because of itching and burning and nothing helped.  The reporter said if you had not had the shot and bonus shot get it, the patient had the shot and still got them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had the shingles vaccine and still got shingles/suspected vaccination failure; shingles; It was still painful!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the Shingles vaccine and still got shingles, just not as severe and it was still painful. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain, Vaccination failure, Vth nerve injury
Clinical narrative: I got my shingles vaccinebut have had it/suspected vaccination failure; had it many times, some on my face; destroyed the Trigeminal nerve; I can't feel the right side of my face.; horribly painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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), shingles, injury to trigeminal nerve, numbness facial and pain. On an unknown date, the outcome of the vaccination failure, shingles, injury to trigeminal nerve, numbness facial and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, injury to trigeminal nerve, numbness facial and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingle vaccine but had shingles more times than he/she could count.  The patient stated it was horribly painful.  The patient got some on face and it had destroyed the trigeminal nerve. The patient could felt much on the right side of face. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, what good did it do to get the shot after you had them. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness at the needle location; sore at the needle location; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The patient got vaccine and it was sore for about two days with redness at the needle location.  The patient was fine now. The reporter reported better than having shingles. Had it over his/her back.  It was worse experience behind Covid.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. 2 years after receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Got a very mild case of it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got mild shingles. The patient stated that, Shingles shots were pricey. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; have had shingles, I've had it seven times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles seven times. The patient asked what was the reason. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/shingles on face, had the shot; shingles on face; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, several 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a shot several years ago and had shingles on his/her face. The patient stated that he/she did not knew that he/she needed another one after so long but he/she would be getting one as soon as he/she can. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.  The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had external twice and internal. The internal are worse than any surgery; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had external one shingle twice and internal one shingle.  The internal were worse than any surgery. The patient stated that, had he/she not the shots, internal ones could travel to any organ and would kill you. The patient's neighbor at the age of 39 years died of internal as they traveled to his lungs. The patient would not wish them on a dog. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; still got it/ having them now; pain/it hurt; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   The reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine, last year from the date of reporting. The patient was vaccinated with Shingles vaccine and it still gave him/her shingles at the time of reporting. The patient agreed with some of them and stated that, it hurt more than having a baby. The patent was in so much pain and stated that nothing helped and asked advice.  This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got three years ago from the date of reporting).   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 details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles worse than before getting the Shingles shot three years ago from the date of reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, 8 months 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 details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. 8 months after receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Worst vaccine I got for pain; This case was reported by a nurse 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. 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.  Additional details were provided as follows: The case was reported by patient who was also a nurse. The age at vaccination was not reported. As a nurse the reporter treated people with shingles, and they stated it was extremely painful.  It was worst vaccine the patient got for pain but was not sure minuscule amount compared to the virus.  They asked to get vaccinated.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, shingles were very painful. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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.   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 details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient stated that, it was not preventable. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: got shingles vaccine and died four months later; This case was reported by a consumer via interactive digital media and described the occurrence of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The reporter stated that, the patient got shingles vaccine and died four months later. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Headache, Pain, Pyrexia
Clinical narrative: headache; cough; chills; body ache; Fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID-19 VACCINE (received 2 doses on an unknown date) and Shingrix with an associated reaction of pyrexia (received the 1st dose in October/ November 2021 and experienced fever and body ache, refer case- US2021AMR259115). Concurrent medical conditions included cancer. Concomitant products included COVID-19 VACCINE.   On 14th December 2021, the patient received the 2nd dose of Shingrix. On 14th December 2021, 8 hrs after receiving Shingrix, the patient experienced headache, cough, chills, general body pain and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, cough, chills, general body pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, cough, chills, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The patient still had cough and was not sure if it was due to Shingrix or if it was Covid related. The reporter stated that, that the symptoms were still ongoing. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR259115:same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: headache; cough; chills; body ache; Fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID-19 VACCINE (received 2 doses on an unknown date) and Shingrix with an associated reaction of pyrexia (received the 1st dose in October/ November 2021 and experienced fever and body ache, refer case- US2021AMR259115). Concurrent medical conditions included cancer. Concomitant products included COVID-19 VACCINE.   On 14th December 2021, the patient received the 2nd dose of Shingrix. On 14th December 2021, 8 hrs after receiving Shingrix, the patient experienced headache, cough, chills, general body pain and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, cough, chills, general body pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, cough, chills, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The patient still had cough and was not sure if it was due to Shingrix or if it was Covid related. The reporter stated that, that the symptoms were still ongoing. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR259115:same reporter
Age: 4.0
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: 4 y/o patient was administrated Hiberix; Dose reconstituted with a steril diluent; Dose reconstituted with a steril diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old male patient who received Hib (Hiberix) (batch number ft775, expiry date 25th June 2022) for prophylaxis.   On 9th December 2021, the patient received Hiberix. On 9th December 2021, unknown after receiving Hiberix, the patient experienced inappropriate age at vaccine administration, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The 4 year old patient was administrated a dose of Hiberix reconstituted with a sterile diluent and not the accompanying and recommended one, which led to inappropriate age at vaccine administration, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further events were reported. The reporter agreed to be contacted for follow-up. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: felt fatigued; achy legs; had no appetite; felt weak; muscle aches; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 16th December 2021, several hours after receiving Shingrix, the patient experienced fatigue, leg pain, appetite absent, feelings of weakness, muscle pain and headache. On an unknown date, the outcome of the fatigue, leg pain, appetite absent, feelings of weakness, muscle pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, leg pain, appetite absent, feelings of weakness, muscle pain and headache to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient received Shingrix vaccine in left arm. The patient states that hours later she felt fatigued and achy legs.  At dinner time she had no appetite and felt weak.  At bedtime she reported muscle aches and a headache.  The reporter spoke per content, referred her to health care professional (HCP). The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: felt fatigued; achy legs; had no appetite; felt weak; muscle aches; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 16th December 2021, several hours after receiving Shingrix, the patient experienced fatigue, leg pain, appetite absent, feelings of weakness, muscle pain and headache. On an unknown date, the outcome of the fatigue, leg pain, appetite absent, feelings of weakness, muscle pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, leg pain, appetite absent, feelings of weakness, muscle pain and headache to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient received Shingrix vaccine in left arm. The patient states that hours later she felt fatigued and achy legs.  At dinner time she had no appetite and felt weak.  At bedtime she reported muscle aches and a headache.  The reporter spoke per content, referred her to health care professional (HCP). The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2021-2022 season) (batch number B49F7, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 25th October 2021, the patient received Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2021, 1 days after receiving Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site pain, pain, fatigue and joint pain. On an unknown date, the outcome of the injection site pain, pain, fatigue and joint pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fatigue and joint pain to be related to Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter was the patient. The patient received a Fluarix vaccine and following day, she experienced severe aches and pains, pain at the injection site and fatigue. The reporter also said that she was extremely sore and her joints ache. He also said that the patient was extremely sore and his joints ache.  He also said that these effects were on going and had not improved and had been debilitating. The reporter was given medical advice disclaimer and was referred to healthcare professional. The reporter gave consent to contact healthcare professional (pharmacy). The reporter consented to follow up. This case was linked to the case US2021259939, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021259939:Same reporter, same product
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: Felt achy after 1st dose; 1st dose a year ago, hasnt got the 2nd; This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain and incomplete course of vaccination. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose and it was not applicable for 2nd dose. The reporter was the patient and mentioned that she felt achy when she received her first Shingrix vaccine in an unknown arm about 1 year prior to the reporting date.  She was hesitant to get the second Shingrix vaccine because she did not want to confuse the achy feeling with Covid-19. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 41-year-old female patient who received HAV (Havrix) (batch number 4H37Y, expiry date 8th November 2020) for prophylaxis. Co-suspect products included Hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 20th December 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th December 2021, 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 details were reported as follows: The patient was inadvertently administered with an expired dose of Havrix. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear pain, Headache, Nausea, Pyrexia
Clinical narrative: earache; headache; nausea; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of ear pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st December 2021 09:40, the patient received the 1st dose of Shingrix. In December 2021, 18 hrs 50 min after receiving Shingrix, the patient experienced ear pain, headache, nausea, fever and chills. On an unknown date, the outcome of the ear pain, headache, nausea, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the ear pain, headache, nausea, fever and chills to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient had her Shingrix and next morning on 22nd December 2021 at 4.30 she started to experience, chills, fever, nausea, earache and a headache.  The reporter was given medical disclaimer, referred to health care professional (HCP), Spoke per (product insert) PI and content. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. Additional details were reported as follows: The age at vaccination was not applicable for this report. Physician reported several patients from internal medicine practice had missed receiving 2nd dose of Shingrix within recommended dosing window due to the COVID-19 pandemic which led to social problem. Reporter did not have patient information or details of 1st vaccine dose. The reporter did not consent to follow-up. Health care professional (HCP) did not want to be contacted for follow-up. HCP declined to provide mailing address or email address.
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Loss of consciousness
Clinical narrative: Knocked out, could not function; This case was reported by a consumer via other manufacturer and described the occurrence of unconscious in a 70-year-old male patient who received Flu Seasonal QIV Dresden (Flu Seasonal QIV Dresden) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis and leuprorelin acetate (Eligard) for product used for unknown indication.   The subject's past medical history included stent placement. Concurrent medical conditions included malignant neoplasm of prostate. Concomitant products included enzalutamide.   On an unknown date, the patient received Flu Seasonal QIV Dresden, COVID-19 VACCINE and Eligard at an unknown dose and frequency. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden, the patient experienced unconscious (serious criteria GSK medically significant and other: Serious as per reporter). The subject was treated with ticagrelor (Brilinta) and acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the unconscious was recovered/resolved.   It was unknown if the reporter considered the unconscious to be related to Flu Seasonal QIV Dresden.  Additional details were provided are as follows: The patient was enrolled in Astellas sponsored patient support program. The age at vaccination was not reported. The patient did not had known medical history and drug allergy. The patient received a dose of Influenza vaccine, a booster dose of Covid-19 vaccine and  leuprorelin (Eligard) on the same day.  It was reported that the patient was knocked out to where he could not function for almost 3 days. The patient was treated with Enzalutamide 160 mg once day for malignant neoplasm of prostate. The patient asked to pharmacist about taking Ticagrelor (Brilinta) and aspirin 325 mg together and the patient stated that he had stent put in the place and was started on ticagrelor  twice daily and was taking once daily along with aspirin but read aspirin dose might be too high. The pharmacist advised per clinical pharmacist that usually ticagrelor was dosed twice daily (as prescribed) along with aspirin 81 mg and also discuss with MDP who prescribed ticagrelor about decreasing of aspirin dose. The action taken with Enzalutamide, leuprorelin, Covid-19 vaccine and influenza vaccine therapy in response to event was unknown. No lab test information were provided. The sender comment was mentioned as unconsciousness was assessed as serious due to medical significant. It was unknown if the reporter considered the unconscious to be related to leuprorelin and Covid-19 vaccine. Note: Enzalutamide was captured as concomitant as it seems patient was taking it for cancer.