chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Nerve pain; Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 81-year-old 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, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and post herpetic neuralgia (Verbatim: Nerve pain).  The outcome of the shingles was recovered/resolved (duration 2 months) and the outcome of the post herpetic neuralgia was not recovered/not resolved.   The reporter considered the shingles to be possibly related to Shingles vaccine. It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingles vaccine.     The company considered the shingles to be possibly related to Shingles vaccine. It was unknown if the company considered the post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The patient received first dose of Shingles vaccine then soon after experienced shingles and it was horrible.  Shingles now faded after 2 months. However, the patient still had nerve pain and the patient hope it ends. The patient stated that at 81, it was most awful, and he/she would not wish this to anyone.  The patient thought they got shingles from first shot and was now afraid of receiving the second dose. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Hypoaesthesia, Limb discomfort, Pain, Paraesthesia
Clinical narrative: Unnecessary severe pain; Numbness in 2 fingers; Tingling in 2 fingers; Whole arm affected; Even after getting the vaccine later got two more; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced pain (Verbatim: Unnecessary severe pain), numbness in fingers (Verbatim: Numbness in 2 fingers), tingling of extremity (Verbatim: Tingling in 2 fingers), arm discomfort (Verbatim: Whole arm affected) and extra dose administered (Verbatim: Even after getting the vaccine later got two more).  The outcome of the pain and arm discomfort were not reported and the outcome of the numbness in fingers and tingling of extremity were not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the pain, numbness in fingers, tingling of extremity and arm discomfort to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the pain, numbness in fingers, tingling of extremity and arm discomfort to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that even after received Shingles vaccine he/she had to later receive two more doses of Shingles vaccine. The patient stated that protect yourself from very unnecessary severe pain. The shingles vaccine left patient with numbness and tingling in two fingers on his/her right hand and his/her whole arm was affected. The patient received extra dose of shingles in error, which led to extra dose administered. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR038386:deletion case
Sex: U
Vaccine: VARZOS
Symptoms: Influenza, Pain in extremity
Clinical narrative: Feel like I have the flu; Very sore arm; 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 Herpes zoster (Shingles vaccine) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingles vaccine. On 04-MAR-2023, 1 days after receiving Shingles vaccine, the patient experienced influenza (Verbatim: Feel like I have the flu). In MAR-2023, the patient experienced pain in arm (Verbatim: Very sore arm).  The outcome of the pain in arm and influenza were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and influenza to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and influenza to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported the patient via interactive digital media. The patient received first shot of vaccine day before reporting. The patient arm was very sore and the patient felt like flu on the day of reporting. The patient was hopefully that the patient would feel better tomorrow.  The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Incomplete course of vaccination, Pain, Pyrexia, Swelling
Clinical narrative: Huge red area; Swollen area; Painful; Feverish; didn't take the 2nd one; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (1st dose received on an unknown date).   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema (Verbatim: Huge red area), swelling (Verbatim: Swollen area), pain (Verbatim: Painful), fever (Verbatim: Feverish) and incomplete course of vaccination (Verbatim: didn't take the 2nd one). The outcome of the erythema, swelling, pain and fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the erythema, swelling, pain and fever to be related to Shingrix.     It was unknown if the company considered the erythema, swelling, pain and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient had huge red and swollen area that was painful and feverish over a week, so the patient did not receive second dose of Shingrix vaccine.  The patient was good. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Rash pruritic
Clinical narrative: very sore; Itchy rash; Red rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: very sore), itchy rash (Verbatim: Itchy rash) and red rash (Verbatim: Red rash).  The outcome of the pain was recovered/resolved and the outcome of the itchy rash and red rash were not reported.   It was unknown if the reporter considered the pain, itchy rash and red rash to be related to Shingles vaccine.     It was unknown if the company considered the pain, itchy rash and red rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2023 This case was reported by the patient via interactive digital media.  The patient experienced very sore for almost a week with a red itchy rash. The patient was hoping that the second dose should be less reactive. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Pain/ stinging/ pinching; Itchinging; Flaking; 1st dose was 2 days bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included rash (I felt a bubble rash burning going around my private area.), feeling abnormal (Felt a bite on my butt), pruritus (Pinching itchy.), stinging (Stinging, Worse pain), shingles (Older doctor walk by said that was Shingles) and burning sensation (Fire).   In OCT-2022, the patient received Shingles vaccine. In OCT-2022, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: 1st dose was 2 days bad), pain (Verbatim: Pain/ stinging/ pinching), pruritus (Verbatim: Itchinging) and flaking skin (Verbatim: Flaking).  The outcome of the feeling bad was recovered/resolved (duration 2 days) and the outcome of the pain, pruritus and flaking skin were not reported.   It was unknown if the reporter considered the feeling bad, pain, pruritus and flaking skin to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad, pain, pruritus and flaking skin to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR038421   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported the patient via interactive digital media. On July 5 th, Wednesday at night the patient felt a bite on butt and went for care. The patient got medication. On Saturday morning after having shower, the patient felt a bubble rash-burning going around the private area.  The patient and his wife went for emergency room visit. Older doctor walk by side and reported that was Shingles. The patient got more medicines. It took 4 weeks to go away. On last July, the patient thought that it was a bug bite or boil on the butt three days later worse pain.  The patient experienced Fire, stinging, pinching itchy. On October the patient received 1 st dose of Shingles vaccine. After vaccination the patient experienced 2 days bad, pain, itchinging and flaking. The patient received 2nd dose of Shingles vaccine on one day prior to GSK receipt date. The follow-up could not be possible as no contact details were available. It was unknown whether patient experienced stinging,pinching itchy after 1st dose, 2nd dose or before receiving any dose. therfore, conservatively capture as event and clarification raised for same.; Sender's Comments:  US-GSK-US2023AMR038421:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Pain/ stinging/ pinching; Itchinging; Flaking; 1st dose was 2 days bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included rash (I felt a bubble rash burning going around my private area.), feeling abnormal (Felt a bite on my butt), pruritus (Pinching itchy.), stinging (Stinging, Worse pain), shingles (Older doctor walk by said that was Shingles) and burning sensation (Fire).   In OCT-2022, the patient received Shingles vaccine. In OCT-2022, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: 1st dose was 2 days bad), pain (Verbatim: Pain/ stinging/ pinching), pruritus (Verbatim: Itchinging) and flaking skin (Verbatim: Flaking).  The outcome of the feeling bad was recovered/resolved (duration 2 days) and the outcome of the pain, pruritus and flaking skin were not reported.   It was unknown if the reporter considered the feeling bad, pain, pruritus and flaking skin to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad, pain, pruritus and flaking skin to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR038421   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported the patient via interactive digital media. On July 5 th, Wednesday at night the patient felt a bite on butt and went for care. The patient got medication. On Saturday morning after having shower, the patient felt a bubble rash-burning going around the private area.  The patient and his wife went for emergency room visit. Older doctor walk by side and reported that was Shingles. The patient got more medicines. It took 4 weeks to go away. On last July, the patient thought that it was a bug bite or boil on the butt three days later worse pain.  The patient experienced Fire, stinging, pinching itchy. On October the patient received 1 st dose of Shingles vaccine. After vaccination the patient experienced 2 days bad, pain, itchinging and flaking. The patient received 2nd dose of Shingles vaccine on one day prior to GSK receipt date. The follow-up could not be possible as no contact details were available. It was unknown whether patient experienced stinging,pinching itchy after 1st dose, 2nd dose or before receiving any dose. therfore, conservatively capture as event and clarification raised for same.; Sender's Comments:  US-GSK-US2023AMR038421:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Had me under the weather; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unwell 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 unwell (Verbatim: Had me under the weather). The outcome of the unwell was recovered/resolved (duration 24 hrs).   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.     It was unknown if the company considered the unwell to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated Shingles vaccine had him /her under the weather for 24 hours approximately. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: 2nd one 3 days nowIt was  kicking my butt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included pneumococcal vaccine (Pneumonia Vaccine) for prophylaxis.   The patient's past medical history included bullous pemphigoid (I felt a bubble rash burning going around my private area.), feeling abnormal (Felt a bite on my butt), stinging (Stinging, Worse pain), pruritus (Pinching itchy.), shingles (Older doctor walk by said that was Shingles), burning sensation (Fire), flaking skin (Flaking) and feeling bad (2 days feeling bad). Previously administered products included shingles vaccine with an associated reaction of pain (1st shingles vaccine in October 2022, refer link case US2023AMR038418).   In MAR-2023, the patient received the 2nd dose of Shingles vaccine. On 03-MAR-2023, the patient started Pneumonia Vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: 2nd one 3 days nowIt was  kicking my butt).  Rechallenge with Shingles vaccine was positive. The outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR038418   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported the patient via interactive digital media. On July 5 th, Wednesday at night the patient felt a bite on butt and went for carenow. The patient got medication. On Saturday morning after having shower, the patient felt a bubble rash-burning going around the private area.  The patient and his wife went for emergency room visit. Older doctor walk by side and reported that was Shingles. The patient got more medicines. It took 4 weeks to go away. On last July, the patient thought that it was a bug bite or boil on the butt three days later worse pain.  The patient experienced Fire, stinging, pinching itchy. On October the patient received 1 st dose of Shingles vaccine. After the first vaccination the patient experienced 2 days bad, pain, itching and flaking. On 3rd march 2023, one day prior to GSK receipt date the patient received 2nd dose of Shingles vaccine. After the second vaccination the patient experienced kicking in the butt and 3 days bad which was ongoing till reporting. It was unknown if the reporter considered the feeling bad to be related to Pneumonia Vaccine.  The follow-up could not be possible as no contact details were available. From narrative it was unclear if patient received vaccine on 3rd March or experiencing events from 3 days. therefore, conservatively captured partial vaccination and event onset date.; Sender's Comments:  US-GSK-US2023AMR038418:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Pain
Clinical narrative: Body ache, head to toe; Discomfort; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: Body ache, head to toe) and discomfort (Verbatim: Discomfort).  The outcome of the general body pain was recovered/resolved and the outcome of the discomfort was recovered/resolved (duration 1 day).   It was unknown if the reporter considered the general body pain and discomfort to be related to Shingles vaccine.     It was unknown if the company considered the general body pain and discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a consumer via interactive digital media. The patient got a Shingles vaccine recently, and beforehand, he/she was unaware there would be two shots involved.  After, the patient got his/her second dose (two months after the first dose), the next day his/her entire body ached from head to toe.  The following day patient felt great, and he/she stated that, at any rate, he/she was certain that one day of utter discomfort was well worth not suffering from shingles for two months. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: shingles; 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 Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles).  The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-Mar-2023 This case was reported by a patient's friend via interactive digital media. The reporter reported that the patient received the shingles vaccine and came down with a horrible case of shingles right after that. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Tooth fracture, Toothache
Clinical narrative: Then got shot too early, got it another 2 weeks; Broke 2 back teeth; Broke 2 back teeth the pain was so bad; Then got shot too early, got it another 2 weeks; 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.   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 weeks after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Then got shot too early, got it another 2 weeks), tooth fracture (Verbatim: Broke 2 back teeth), toothache (Verbatim: Broke 2 back teeth the pain was so bad) and drug dose administration interval too short (Verbatim: Then got shot too early, got it another 2 weeks). The outcome of the shingles was not recovered/not resolved and the outcome of the tooth fracture and toothache were not reported and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the shingles, tooth fracture and toothache to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the shingles, tooth fracture and toothache to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case was received from the patient via interactive digital media. The patient stated that 7 weeks of purred hell he/she got Shingles shot too early, got shingles in another 2 weeks. The patient broke 2 back teeth the pain was so bad. The patient stated that now year and half he/she still felt like 10,000 ants crawling on him/her at times. The patient stated that it was like never going away. 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
Symptoms: Herpes zoster
Clinical narrative: Had shingles; 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 Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Had shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient got vaccinated and within 2 weeks he/she had shingles go figure. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Stress, Temperature intolerance
Clinical narrative: Still got Shingles; Pain where blisters were; Blisters; 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. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Still got Shingles), pain (Verbatim: Pain where blisters were) and blister (Verbatim: Blisters).  The outcome of the shingles and blister were not reported and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain and blister to be related to Shingles vaccine.     It was unknown if the company considered the shingles, pain and blister to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR038443   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a consumer via interactive digital media. The patient had a Shingles shot but still got the shingles, and he/she still have pain where the blisters were.  The patient reported that, when he/she had stressful day or the weather was hot or cold, the patient had pain where the blisters were. The follow up would not possible as no contact details were available. For the tolerance of 2nd dose refer case US2023AMR038443, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR038443:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: Not help with Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (1st dose received on an unknown date, refer case US2023AMR038443).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Not help with Pain).  Rechallenge with Shingles vaccine was positive. The outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR038442   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a consumer via interactive digital media. The patient reported that, his/her doctor gave the patient another Shingles vaccine booster (2nd) dose and that did not help with the pain. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR038442:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia, Neuralgia
Clinical narrative: Muscle pain; Nerve pain; Leg cramps; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain 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 muscle pain (Verbatim: Muscle pain), nerve pain (Verbatim: Nerve pain) and leg cramps (Verbatim: Leg cramps).  The outcome of the muscle pain, nerve pain and leg cramps were not reported.   It was unknown if the reporter considered the muscle pain, nerve pain and leg cramps to be related to Shingles vaccine.     It was unknown if the company considered the muscle pain, nerve pain and leg cramps to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a consumer via interactive digital media. The patient stated that, he/she gave a warning to all and said, did not get the shingle shot. The patient received the Shingles shot and had muscle pain from it, and stated that, side effects were worse than shingles.  The patient got nerve pain and leg cramps. The patient said, sorry but it was true, and stated, then they tell you after, part 2 was part of it. The side effects were worse. The patient stated, he/she never had that ever, and said forget the shot. The follow up would not possible as no contact details were available. The case had been linked with US2023AMR038453, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR038453:Same reporter - Friend's case
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Sciatica, Walking aid user
Clinical narrative: Sciatica, back and legs, used walker for 3 months; Side effects were awful/ he is not the same; Used walker 3 months; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sciatica in a 78-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sciatica (Verbatim: Sciatica, back and legs, used walker for 3 months), feels awful (Verbatim: Side effects were awful/ he is not the same) and walker user (Verbatim: Used walker 3 months).  The outcome of the sciatica and feels awful were recovering/resolving and the outcome of the walker user was recovered/resolved.   It was unknown if the reporter considered the sciatica, feels awful and walker user to be related to Shingles vaccine.     It was unknown if the company considered the sciatica, feels awful and walker user to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by the patient's friend via interactive digital media. The reporter reported that, his/her friend (patient) got Shingles vaccine part 2 and the side effects were awful patient said.  The patient never had sciatica, back and legs, but now he had it.  The patient used walker 3 months, and said it was better, but the patient was not the same. The follow-up could not be possible as no contact details were available. The case had been linked with US2023AMR038451, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR038451:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: they were sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: they were sick). The outcome of the sickness was recovered/resolved.   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.   Linked case(s) involving the same patient:  US2023AMR038745   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported from the consumer via interactive digital media. The reporter stated that lot of people got both shingles shots and they were sick for a couple of days. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR038745:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: they were sick; Reason for case deletion: As per reported information, it was not clear after which shot of shingles vaccine patient had experienced the event. Therefore, one case was kept valid one without dose number as case of record (US2023AMR038711) and deleted the other case (US2023AMR038745) as case created in error.; Sender's Comments:  US-GSK-US2023AMR038711:same reporter US-GSK-US2023AMR038711:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Tenderness
Clinical narrative: Arm sore and tender; Shoulder sore and tender; Arm and shoulder sore and tender; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 87-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (had routine shingles shots years ago).   On 28-FEB-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm sore and tender), shoulder soreness (Verbatim: Shoulder sore and tender) and tenderness (Verbatim: Arm and shoulder sore and tender).  The outcome of the pain in arm, shoulder soreness and tenderness were recovered/resolved (duration 2 days).   It was unknown if the reporter considered the pain in arm and tenderness to be related to Shingrix. It was not reported if the reporter considered the shoulder soreness to be related to Shingrix.     It was unknown if the company considered the pain in arm and tenderness to be related to Shingrix. It was not reported if the company considered the shoulder soreness to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had got routine shingles shots years ago. The patient experienced arm and shoulder sore and tender for about two days then went looked forward for second dose in two months. The follow-up could not be possible as no contact details were available.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Experienced shingles outbreaks; 1st dose 12Feb2020, 2nd never; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number LH7ED, expiry date 25-MAR-2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12-FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: Experienced shingles outbreaks) and incomplete course of vaccination (Verbatim: 1st dose 12Feb2020, 2nd never).  In FEB-2023, the outcome of the shingles was recovered/resolved. The outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-Mar-2023 The pharmacist reported that a patient never returned for second dose.  The patient had experienced shingles outbreaks a couple of times after receiving the first dose.  The most recent case just resolved about a week ago.  At the time of reporting, a second dose had not administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Redness at injection site; Pain at injection site; Most painful shot; Chills, shivering; Shoulder pain; Painful arm movement; Fever; Felt nauseated; Tender, painful to touch; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood cholesterol increased and blood pressure high.   On 06-JAN-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site), injection site pain (Verbatim: Pain at injection site), pain (Verbatim: Most painful shot), chills (Verbatim: Chills, shivering), shoulder pain (Verbatim: Shoulder pain), pain in arm (Verbatim: Painful arm movement), fever (Verbatim: Fever), nausea (Verbatim: Felt nauseated) and tenderness (Verbatim: Tender, painful to touch).  The outcome of the injection site erythema, injection site pain, pain, chills, shoulder pain, pain in arm, fever, nausea and tenderness were recovered/resolved (duration 2 days).   It was unknown if the reporter considered the injection site erythema, injection site pain, pain, chills, shoulder pain, pain in arm, fever, nausea and tenderness to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain, pain, chills, shoulder pain, pain in arm, fever, nausea and tenderness to be related to Shingrix.   Additional Information: GSK Receipt date: 03-Mar-2023 The reporter was a 79-year-old male.  The reporter reports he had his first dose of Shingrix vaccine.  Vaccine was provided at patient's primary care doctor's office.  The patient reports that he got the vaccine in the left arm and it was the most painful shot in my life. Patient reports having redness at injection site, pain at injection site, chills, shoulder pain, painful arm movement, fever, shivering, felt nauseated, tender to touch, and painful to touch.  The patient reports symptoms last for about 2 days. Patient reports he only takes medications for high blood pressure (HBP) and cholesterol. The reporter did not consent to follow-up. The reporter did not have all information was available.  Lot number and expiration date were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Redness at injection site; Pain at injection site; Most painful shot; Chills, shivering; Shoulder pain; Painful arm movement; Fever; Felt nauseated; Tender, painful to touch; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood cholesterol increased and blood pressure high.   On 06-JAN-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site), injection site pain (Verbatim: Pain at injection site), pain (Verbatim: Most painful shot), chills (Verbatim: Chills, shivering), shoulder pain (Verbatim: Shoulder pain), pain in arm (Verbatim: Painful arm movement), fever (Verbatim: Fever), nausea (Verbatim: Felt nauseated) and tenderness (Verbatim: Tender, painful to touch).  The outcome of the injection site erythema, injection site pain, pain, chills, shoulder pain, pain in arm, fever, nausea and tenderness were recovered/resolved (duration 2 days).   It was unknown if the reporter considered the injection site erythema, injection site pain, pain, chills, shoulder pain, pain in arm, fever, nausea and tenderness to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain, pain, chills, shoulder pain, pain in arm, fever, nausea and tenderness to be related to Shingrix.   Additional Information: GSK Receipt date: 03-Mar-2023 The reporter was a 79-year-old male.  The reporter reports he had his first dose of Shingrix vaccine.  Vaccine was provided at patient's primary care doctor's office.  The patient reports that he got the vaccine in the left arm and it was the most painful shot in my life. Patient reports having redness at injection site, pain at injection site, chills, shoulder pain, painful arm movement, fever, shivering, felt nauseated, tender to touch, and painful to touch.  The patient reports symptoms last for about 2 days. Patient reports he only takes medications for high blood pressure (HBP) and cholesterol. The reporter did not consent to follow-up. The reporter did not have all information was available.  Lot number and expiration date were unknown.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Blister on wrist, arm; Red arm; Swelling arm; Painful arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of blister in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAR-2023, the patient received the 2nd dose of Shingrix. On 02-MAR-2023, 1 days after receiving Shingrix, the patient experienced blister (Verbatim: Blister on wrist, arm), erythema of extremities (Verbatim: Red arm), swelling arm (Verbatim: Swelling arm) and pain in arm (Verbatim: Painful arm).  The outcome of the blister, erythema of extremities, swelling arm and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the blister, erythema of extremities, swelling arm and pain in arm to be related to Shingrix.     It was unknown if the company considered the blister, erythema of extremities, swelling arm and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date: 03-Mar-2023 The reporter stated she received the second dose of the vaccine and the next day she developed a blister on her wrist and arm.  The reporter stated her arm was red, swollen, and the area was painful.  AE filed.  The reporter stated she sought medical guidance form the registered pharmacist at the pharmacy where she received the vaccination. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023034613:same reporter
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Irritability, Pruritus, Sensitive skin
Clinical narrative: itchy dry skin; Skin is sensitive to cloth, sheets; drive me nuts; This non-serious case was reported by a consumer via call center representative and described the occurrence of dry skin in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu shot (on an unknown date patient received flu shot), covid 19 (on an unknown date patient received covid 19 shot) and Shingrix with an associated reaction of pruritus (received shingrix dose-1 on 29-Oct-2022, refere linked case US2023AMR035201). Concurrent medical conditions included pruritus. Concomitant products included COVID-19 VACCINE (COVID-19 BOOSTER).   On 10-JAN-2023, the patient received the 2nd dose of Shingrix (intramuscular, right arm) 50 ug. On 10-JAN-2023, the dose was 50 ounce. On an unknown date, an unknown time after receiving Shingrix, the patient experienced dry skin (Verbatim: itchy dry skin), sensitive skin (Verbatim: Skin is sensitive to cloth, sheets) and feeling irritated (Verbatim: drive me nuts).  The outcome of the dry skin, sensitive skin and feeling irritated were not recovered/not resolved.   It was unknown if the reporter considered the dry skin, sensitive skin and feeling irritated to be related to Shingrix.     It was unknown if the company considered the dry skin, sensitive skin and feeling irritated to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR035201   Additional Information: GSK Receipt date- 03-MAR-2023 The reporter was the patient.  The patient did not have email.  The reporter reported that he received his first Shingrix shot on and ever since the first shot his chest, back, and arms itch all the time. There was no redness. There was no breakout. But his skin was now sensitive to cloth and sheets.  One thing he had tried which helps a bit was when he showers he uses body wash which was recommended for itchy dry skin because it contains no alcohol.  This event had not resolved and he said that it was driving me nuts. Patient reported that after receiving his second Shingrix shot which was also the same day he received his final Covid-19 booster shot. The patient was unable to find the lot number for the Shingrix vaccines but he did provide the pharmacy contact information which should have the lot numbers on file. The reported was consented to follow up. The reporter did not currently have a primary care physician. Patient was willing to share his new MD contact information with GSK in the future if he receives a letter requesting it.; Sender's Comments:  US-GSK-US2023AMR035201:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise
Clinical narrative: sick feeling; shivering; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-MAR-2023, the patient received Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: sick feeling) and shivering (Verbatim: shivering).  The outcome of the feeling unwell and shivering were unknown.   It was unknown if the reporter considered the feeling unwell and shivering to be related to Shingrix.     It was unknown if the company considered the feeling unwell and shivering to be related to Shingrix.   Additional Information: GSK Receipt date: 03-Mar-2023 The reporter stated she was visiting her register pharmacist (RPH) for medical guidance.  The reporter states her the RPH reported to her that he had gotten a dose of Shingrix and was experiencing shivering and a sick feeling. Did not consent to follow-up.; Sender's Comments:  US-GSK-US2023034610:same reporter
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Numbness at injection site; Incomplete course of vaccination; The site of injection was red; The site of injection was painful; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 9Hm59, expiry date 30-SEP-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26-AUG-2022, the patient received the 1st dose of Shingrix (left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 26-AUG-2022, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: The site of injection was red) and injection site pain (Verbatim: The site of injection was painful). On an unknown date, the patient experienced injection site numbness (Verbatim: Numbness at injection site) and incomplete course of vaccination (Verbatim: Incomplete course of vaccination).  . Thethe outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site numbness to be related to Shingrix and Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain and injection site numbness to be related to Shingrix and Shingrix.   Linked case(s) involving the same patient:  US2023034606   Additional Information: GSK Receipt Date: 03-MAR-2023 The reporter was pharmacist. The reporter reported that the patient had received their first dose in August 26, 2022, till then the patient have not received the second dose. The site of injection was red and painful for about 3 weeks after receiving the first dose of Shingrix. Currently, there was no redness or pain, but the site of the injection was numb.  The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023034606:same reporter - FU1 deleted