chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Patient still got mild shingles after vaccination/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (patient's sister and niece both had it).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient still got mild shingles after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that it was two shots, which the husband and patient both had. The patient still got shingles, but it was a mild case.  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, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Patient had shingles after vaccine shot/Suspected vaccination failure; moved from my eye to back and all the way down to right arm and thumb; Shingles worsened; This serious 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included herpes ocular.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient had shingles after vaccine shot/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: moved from my eye to back and all the way down to right arm and thumb) and condition aggravated (Verbatim: Shingles worsened). The outcome of the vaccination failure was unknown and the outcome of the shingles and condition aggravated were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and condition aggravated to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and condition aggravated to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that the patient already had chronic shingles in the right eye and since the 2nd injection it had moved from the eye to the back and all the way down to the right arm and thumb. The pharmacist told the patient it should lessen the disease/outbreak severity but it seemed to have made it worse instead. 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. 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: Patient had shingles after vaccine shots/Suspected vaccination failure; Shingles; This serious 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.   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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient had shingles after vaccine shots/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2024  This case was reported by a patient via interactive digital media. The patient stated that he/she was just diagnosed with Shingles even though he/she had two shots. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I know more people who had shingles after shots but no one has had it who did not take it/ Suspected vaccination failure; I know more people who had shingles after shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I know more people who had shingles after shots but no one has had it who did not take it/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I know more people who had shingles after shots). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2024 This case was reported by a consumer via interactive digital media. The reporter would passed. The reporter read the inserts. The reporter knew more people who had shingles after shots but no one has had it who did not take it. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Gait inability, Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillain-Barre syndrome; paralyzed from the neck down; Unable to walk; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 days after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria GSK medically significant), paralysis (Verbatim: paralyzed from the neck down) (serious criteria GSK medically significant) and unable to walk (Verbatim: Unable to walk). The outcome of the guillain barre syndrome was not reported and the outcome of the paralysis was resolved (duration 2 months) and the outcome of the unable to walk was resolved (duration 1 year).   It was unknown if the reporter considered the guillain barre syndrome, paralysis and unable to walk to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome, paralysis and unable to walk to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2024 This case was reported by a patient via interactive digital media. The patient got Guillain-Barre syndrome five days after getting the shot, it took the patient a year to be able to walk, paralyzed from the neck down for two months.
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Immediate post-injection reaction
Clinical narrative: stroke; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced stroke (Verbatim: stroke) (serious criteria GSK medically significant). The outcome of the stroke was not reported.   It was unknown if the reporter considered the stroke to be related to Shingles vaccine.     It was unknown if the company considered the stroke to be related to Shingles vaccine.   Additional Information: GSK received date: 09-Mar-2024 This case was reported by a reporter via interactive digital media. Patient had a very severe case from is shoulder up and just got the shot just over a week ago. He also had a stroke right after the shot. 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: got shingles months later / Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a specified number of patients 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 Shingles vaccine and Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles months later / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2024 This case was reported by a patient's friend via interactive digital media. The reporter reported that his/her friends 3 of them got the shingles shot and then also got the Jab then got shingles months later. The reporter wonders how came. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Patinet developed shingles after vaccination/Suspected vaccination failure; Shingles on the left side of the head and neck; Pain; Chills; This serious 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.   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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patinet developed shingles after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on the left side of the head and neck), chills (Verbatim: Chills) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported and the outcome of the chills was resolved (duration 1 day).   It was unknown if the reporter considered the vaccination failure, shingles, chills and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, chills and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that last year was the first year thar insurance paid 100 percent. It was a combination of two in a 6-month period. The first shot the patient felt pretty good, the second one the patient had some chills for a day. If you had Chickenpox, the patient highly recommended it. The patient developed shingles on the left side of the head and neck. The patient did not even have the words to describe the pain. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: I took the shot and the booster but still got shingles on my face in my left eye and my head/ Suspected vaccination failure; got shingles on my face in my left eye and my head; I took the shot and the booster but still got shingles on my face in my left eye and my head; so painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I took the shot and the booster but still got shingles on my face in my left eye and my head/ Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: got shingles on my face in my left eye and my head) (serious criteria GSK medically significant), shingles (Verbatim: I took the shot and the booster but still got shingles on my face in my left eye and my head) and pain (Verbatim: so painful). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2024 This case was reported by a patient via interactive digital media. The patient took the dose and the booster dose but still got shingles on face in left eye and head and it was so painful. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case had been linked with US2024AMR029305, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2024AMR029305:husband case
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK received date: 08-MAR-2024 This case was reported by a patient via interactive digital media. The patient had experienced shingles after vaccination as well. 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. The case had been linked to US2024AMR031316, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024AMR031316:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 3 days).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-MAR-2024 This case was reported the patient via interactive digital media. The patient came down with shingles two weeks ago thanked to the vaccine.  The patient had a very mild case and was taken care of very quickly only really it somewhat for three days This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Illness, Pain in extremity
Clinical narrative: big red area on my arm; Pain in arm; Sick; This non-serious 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, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick), erythema of extremities (Verbatim: big red area on my arm) and pain in arm (Verbatim: Pain in arm). The outcome of the sickness was resolved (duration 3 days) and the outcome of the erythema of extremities and pain in arm were not reported.   It was unknown if the reporter considered the sickness, erythema of extremities and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the sickness, erythema of extremities and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by the patient via interactive digital media. The patient had shingle shot and had bad reaction, sick for 3 days.  There was big red area on patient's arm painful.
Sex: U
Vaccine: RSV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: my arm is in a lot of pain; my arm is swollen; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: my arm is in a lot of pain) and swelling arm (Verbatim: my arm is swollen). The outcome of the pain in arm and swelling arm were not resolved.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Arexvy.     It was unknown if the company considered the pain in arm and swelling arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient stated that his/her arm was in a lot of pain and swollen.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Herpes ophthalmic, Herpes zoster
Clinical narrative: dull headache on left side of head; shingles/ started on eye lid; This non-serious 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 the 1st dose of Shingles vaccine. In FEB-2024, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles/ started on eye lid). On an unknown date, the patient experienced headache (Verbatim: dull headache on left side of head). The patient was treated with paracetamol (Tylenol), valaciclovir hydrochloride (Valacyclovir) and methylprednisolone aceponate (Methylprednisolone). The outcome of the shingles was resolving and the outcome of the headache was not resolved.   It was unknown if the reporter considered the shingles and headache to be related to Shingles vaccine.     It was unknown if the company considered the shingles and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2024 This case was reported by a patient via interactive digital media. The patient had the shingles vaccination in 2021. He/she found out last week (from the date of reporting) that it comes in 2 rounds a little while apart but patient never received for  some reason. The patient was told last week that he/she had shingles. He/she caught it very early as it started on his/her eye lid. With medications and Tylenol, it had been a very light case.  The patient it up on his/her forehead and across his/her scalp. The patient never broke out in one blister. It was like the medications dried it up from day to day from the inside.  The patient consider himself/herself so blessed since he/she had heard nothing but horror stories of shingles since.  They gave patient Valacyclavir and Methyl prednisolone. The patient still has a dull headache on left side of head but he/she was only on day 6 after being diagnosed.  The patient reported that, he/she would definitely be going for his/her second dose in a month or so.
Sex: U
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: high fever, in excess of 102 degrees F.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: high fever, in excess of 102 degrees F.). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Arexvy.     It was unknown if the company considered the fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 The case was received from the patient via interactive digital media. The patient received Arexvy vaccine. The reporter reported that they forgot to mention high fever, in excess of 102 degrees F. The follow-up would not required per process.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm pain). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2024 This case was reported by a patient via interactive digital media. The patient had one Shingles shot and had arm pain, but he did not get shingles. The patient stated that his wife had it. The patient further stated that trust him whatever happened with the vaccine that a lot of people try to scare you, and nothing was compared to the virus pain.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: head to toes chicken pox; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced chickenpox (Verbatim: head to toes chicken pox). The outcome of the chickenpox was not reported.   The reporter considered the chickenpox to be related to Shingles vaccine.     The company considered the chickenpox to be related to Shingles vaccine.   Additional Information: GSK Receive Date: 05-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated vaccine gave him/her head to toes chicken pox.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick with both shots; This non-serious 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, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick with both shots). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2024 This case was reported by a patient via interactive digital media. The patient was glad that he/she got the shingles vaccination, however it was not easy.  The patient was so sick with the shot.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Joint swelling, Pain, Pyrexia
Clinical narrative: hot to touch; Raised and pink to elbow; Raised and pink to elbow; very sore; slight fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling hot 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, an unknown time after receiving Shingles vaccine, the patient experienced feeling hot (Verbatim: hot to touch), swelling of elbows (Verbatim: Raised and pink to elbow), skin red (Verbatim: Raised and pink to elbow), pain (Verbatim: very sore) and fever (Verbatim: slight fever). The outcome of the feeling hot, swelling of elbows, skin red, pain and fever were not reported.   It was unknown if the reporter considered the feeling hot, swelling of elbows, skin red, pain and fever to be related to Shingles vaccine.  It was unknown if the company considered the feeling hot, swelling of elbows, skin red, pain and fever to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR030321   Additional Information: GSK Receipt Date: 05-MAR-2024 This case was reported by a patient via interactive digital media. The patient reported that after receiving 1st dose had crazy reaction (hot to touch, raised and pink to elbow, very sore) and slight fever. For tolerance of 2nd dose refer case US2024AMR030321, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR030321:same patient, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Inflammation, Pain
Clinical narrative: still hot; sore; inflamed; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling hot in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of feeling hot (On an unknown date received 1st dose and experienced crazy reaction, for tolerance of 1st dose refer this case-US2024AMR029713).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced feeling hot (Verbatim: still hot), pain (Verbatim: sore) and inflammation (Verbatim: inflamed). Rechallenge with Shingles vaccine was positive. The outcome of the feeling hot and inflammation were not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the feeling hot, pain and inflammation to be related to Shingles vaccine.   It was unknown if the company considered the feeling hot, pain and inflammation to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR029713   Additional Information: GSK Receipt Date: 05-MAR-2024 This case was reported by a patient via interactive digital media. The patient received 2nd dose and had minimal reaction. At the time of reporting still hot/inflamed and sore after 4 days. The reporter would take the reaction over a moderate/severe shingles any day. The reporter had seen younger people affected more and more. The reporter believed there was a connection with the chickenpox vaccine.; Sender's Comments:  US-GSK-US2024AMR029713:same patient, different dose
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: My husband got his first shingrex vaccine 06/15/2022 never got second dose; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15-June-2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: My husband got his first shingrex vaccine 06/15/2022 never got second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-MAR-2024 The patient never got second dose of Shingrix and asked if he had to start all over again and get both or just the second dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Asthenia, Muscle spasms, Musculoskeletal disorder
Clinical narrative: Leg issue; Weakness; muscle spasms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of musculoskeletal disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced musculoskeletal disorder (Verbatim: Leg issue), weakness (Verbatim: Weakness) and muscle spasm (Verbatim: muscle spasms). The outcome of the musculoskeletal disorder, weakness and muscle spasm were not reported.   It was unknown if the reporter considered the musculoskeletal disorder, weakness and muscle spasm to be related to Shingles vaccine.     It was unknown if the company considered the musculoskeletal disorder, weakness and muscle spasm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024AMR033187   Additional Information: GSK Receipt Date: 07-MAR-2024 This case was reported by a patient via interactive digital media. The patient got the shingles shot first and then the Covid shot. The patient has been having leg issues since, weakness and muscle spasms. It was unknown if the reporter considered the musculoskeletal disorder, weakness and muscle spasm to be related to COVID-19 vaccine.; Sender's Comments:  US-GSK-US2024AMR033187:
Sex: U
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 26-OCT-2023, the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dosage form, administered subcutaneously as prophylaxis (lot #X018575 has been verified to be valid, expiration date not reported but upon internal validation established as 05-JAN-2025) (strength was not provided); diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL), 1 dosage form, lot # U7656AA, dose 5 of 5, administered intramuscularly for an unknown indication (strength, formulation, and expiry date were not provided); and fourth dose of covid-19 vaccine mrna (COVID-19 VACCINE MRNA), at a dose of 0.5 milliliter, lot # AU5558B, administered intramuscularly as covid-19 prophylaxis (strength, formulation, and expiry date were not provided).  On an unknown date in 2023, the patient experienced Fever (pyrexia). On an unknown date in 2023, the patient recovered from the event of pyrexia.   The causal relationship between pyrexia and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) was not provided, yet considered as not related for covid-19 vaccine mrna (COVID-19 VACCINE MRNA).
Age: 2.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Caller reported no side effects or symptoms/no additional AE; Nurse called to report their office inadvertently administered PROQUAD and VARIVAX was administered to two-year-old rather than the MMR II.  No further clinical information provided.  Caller reported no side effects or symptoms.  Upon returning from; Extra dose administered; This spontaneous report was received from a nurse and refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-MAR-2024, the patient was vaccinated at a clinic with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #X011982, (expiration date: 22-OCT-2024), administered for prophylaxis (strength, dose and route of administration were not provided); and  with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W008711, (expiration date: 14-MAR-2024), administered for prophylaxis (strength, dose and route of administration were not provided) (Extra dose administered), inadvertently administered rather than measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, (indication: prophylaxis) (strength, dose description, lot #, expiry date, and route of administration were not provided) (Wrong product administered). No further clinical information provided. No side effects, symptoms or additional adverse events (AEs) were reported (No adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: The medical assistant told field employee that a 10 or 11 year old patient fainted right after receiving a GARDASIL 9 dose..  The patient recovered.   No additional AEs were repor; This spontaneous report was received from medical assistant and refers to a unspecified age (10-11 year old) child patient (unspecified gender). No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, first dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  It was reported that patient fainted right after receiving the vaccine (syncope). On an unknown date the patient recovered for the event.   The causal relationship between syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Upon internal review the event syncope was determined to be medically significant.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: administration of an extra dose of Engerix-B to a 2 y/o who had completed the Hepatitis-B series; patient should have been administered Hepatitis-A vaccine (Non-GSK vaccine) instead.; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 2-year-old male patient who received HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   Previously administered products included Hepatitis B vaccine (received the first dose of Hepatitis-B on unknown date date), Hepatitis B vaccine (received the second dose of Hepatitis-B on unknown date) and Hepatitis B vaccine (received the third dose of Hepatitis-B on unknown date).   On 04-MAR-2024, the patient received Engerix B pediatric. On 04-MAR-2024, an unknown time after receiving Engerix B pediatric, the patient experienced extra dose administered (Verbatim: administration of an extra dose of Engerix-B to a 2 y/o who had completed the Hepatitis-B series) and wrong vaccine administered (Verbatim: patient should have been administered Hepatitis-A vaccine (Non-GSK vaccine) instead.). The outcome of the extra dose administered and wrong vaccine administered 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: 04-MAR-2024 The registered nurse reported the patient who had completed the Hepatitis-B series administered the extra dose of Engerix B instead of administering Hepatitis-A vaccine (Non-GSK vaccine) vaccine which led to Extra dose administered and Wrong vaccine administered. The reporter consented to follow up.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree C; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 21-year-old female patient who received HAV (Havrix) for prophylaxis.   On 04-JAN-2024, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Havrix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree C). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 05-MAR-2024 The front desk worker reported that, the Havrix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree Celsius and after this temperature excursion vaccine was administered to a patient, which led to an incorrect storage of drug. The reporter consented to follow up.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix vaccine was stored outside of recommended storage conditions, exposed to -0.8°C; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 21-year-old female patient who received HAV (Havrix) for prophylaxis.   On 04-JAN-2024, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Havrix vaccine was stored outside of recommended storage conditions, exposed to -0.8°C). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 05-MAR-2024 The reporter called to report Havrix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree Celsius and was administered to a patient, which led to Incorrect storage of drug. Lot number was asked and declined. The reporter consented to follow up via email.
Age: 20.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Pediarix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8°C; after this temperature excursion vaccine was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 20-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 08-FEB-2024, the patient received Pediarix. On 08-FEB-2024, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: after this temperature excursion vaccine was administered to a patient). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: Pediarix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8°C). The outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 05-MAR-2024 The front desk worker reported that, the Pediarix vaccine was stored outside of recommended storage  conditions, exposed to minus 0.8 degree Celsius and after this temperature excursion vaccine was administered to a patient later than the recommended age, which led to an incorrect storage of drug and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 20.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Pediarix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree C; after this temperature excursion vaccine was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 20-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 11-JAN-2024, the patient received Pediarix. On 11-JAN-2024, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: after this temperature excursion vaccine was administered to a patient). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: Pediarix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree C). The outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 05-MAR-2024 The front desk worker reported that, the Pediarix vaccine was stored outside of recommended storage  conditions, exposed to minus 0.8 degree Celsius and after this temperature excursion vaccine was administered to a patient later than the recommended age, which led to an incorrect storage of drug and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Pediarix administration after storage error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 25-JAN-2024, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: Pediarix administration after storage error). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-MAR-2024 The front desk worker reported that a Pediarix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree C. After this temperature excursion vaccine was administered to a patient, which led to incorrect storage of drug.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose was received five years ago and never received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had received 1st dose five years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: First dose was received five years ago and never received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-MAR-2024 The pharmacist reported that the patient received the first dose and never received the second dose. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.