chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Fall, Paralysis
Clinical narrative: paralyzed from the neck down, unable to turn in bed; fall, twice down multiple flights of stairs; Unable to even turn in bed; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced paralysis (Verbatim: paralyzed from the neck down, unable to turn in bed) (serious criteria hospitalization and GSK medically significant), fall (Verbatim: fall, twice down multiple flights of stairs) (serious criteria hospitalization) and bedridden (Verbatim: Unable to even turn in bed) (serious criteria hospitalization). The outcome of the paralysis, fall and bedridden were not reported.   It was unknown if the reporter considered the paralysis, fall and bedridden to be related to Shingrix.     It was unknown if the company considered the paralysis, fall and bedridden to be related to Shingrix.   Additional Information: GSK receipt date: 01-MAY-2023, 02-MAY-2023 This case was reported by patient via interactive digital media. The patient received the shingles vaccine (Shingrix by GSK) and was paralyzed. The patient reported that about a week after receiving the Shingrix vaccine, he started to fall hard around the house for no reason, twice down multiple flights of stairs. The patient reported that within 2 plus weeks he was paralyzed from the neck down, unable to even turn in bed and had to be hospitalized. Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had both shots, and still got them/suspected vaccination failure; still got them; 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: Had both shots, and still got them/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got them). 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: 30-APR-2023 This case was reported by a patient via interactive digital media. The patient had both shingles shots of the new vaccine and still got shingles, not as bad but he/she could not imagine any worse pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Gait disturbance, Guillain-Barre syndrome, Mechanical ventilation, Pain, Paralysis
Clinical narrative: went from normal to paralyzed/being paralyzed; Guillain Barre syndrome; Incredible pain; learning to walk again; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis 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 paralysis (Verbatim: went from normal to paralyzed/being paralyzed) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant), pain (Verbatim: Incredible pain) and walking difficulty (Verbatim: learning to walk again). The outcome of the paralysis and walking difficulty were resolving and the outcome of the guillain barre syndrome and pain were not reported.   It was unknown if the reporter considered the paralysis, guillain barre syndrome, pain and walking difficulty to be related to Shingles vaccine.     It was unknown if the company considered the paralysis, guillain barre syndrome, pain and walking difficulty to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case  was received from the patient via interactive digital media. The patient reported that shingles vaccine greatly increases the risk of developing Guillain Barre Syndrome and you did not want any of that, so look it up.  The patient stated that he/she was learning to walk again after being paralyzed for 5 months and possibly kill you. The patient stated that he/she went from normal to paralyzed and in incredible pain plus on the ventilator.  The patient stated that, 9 months later he/she was learning to walk again.  The patient stated that he/she had rather had shingles again any day over this. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles, had the shots to/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: Had shingles, had the shots to/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 Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot and had shingles 5 years ago.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Formication, Herpes zoster, Rash, Vaccination failure
Clinical narrative: have had them two times after I had the vaccine/Suspected vaccination failure; Shingles/it was internal; felt like worms crawling around; rash; 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.   The patient's past medical history included shingles.   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: have had them two times after I had the vaccine/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles/it was internal), crawling sensation (Verbatim: felt like worms crawling around) and rash (Verbatim: rash). The outcome of the vaccination failure was unknown and the outcome of the shingles, crawling sensation and rash were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, crawling sensation and rash to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, crawling sensation and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles three times and two times after he/she had the shingles vaccine. The reporter stated that one time it was all internal and felt like worms crawling around the same area that broken out in the rash. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got vaccine 6 months later 2nd vaccine booster. 2 yrs later i had internal shingles/ Suspected vaccination failure; Internal shingles/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, 2 years after receiving Shingles vaccine and 2 years 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got vaccine 6 months later 2nd vaccine booster. 2 yrs later i had internal shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Internal shingles/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: 31-March-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received both doses of shingles vaccine 6 months apart and 2 years later experienced internal shingles. The patient stated that do not get the vaccine. This case was considered as suspected vaccination failure as 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: Herpes zoster, Vaccination failure
Clinical narrative: got the shot, got shingles/suspected vaccination failure; shingles off and on for five years; 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.   The patient's past medical history included shingles (had bout with shingles).   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: got the shot, got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles off and on for five years). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved (duration 5 years).   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: 31-Mar-2023 The case was received form the patient via interactive digital media. The patient got the shot and it caused him or her to had shingles off and on for five years. The physician  said that he had never seen it happen before. The patient had learned throughout his or her decisions to pray, talk with your physician and make the decision you feel it was right for you. The patient stated that shingles were horrible. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine and also got the shingles/suspected vaccination failure; Shingles on forehead and hairline; awful; 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: Had the vaccine and also got the shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on forehead and hairline) and feels awful (Verbatim: awful). The outcome of the vaccination failure was unknown and the outcome of the shingles and feels awful were recovered/resolved (duration 6 weeks).   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient had the vaccine and also got the shingles on his or her forehead and hairline awful for 6 weeks. The patient stated that good thing he or she was alone in the pandemic isolation. The vaccine did not prevent shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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, Pain, Vaccination failure
Clinical narrative: Many break outs since having the vaccine, got 2 shots/ Suspected vaccination failure; Many break outs of shingles; Hurt; 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, less than 4 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Many break outs since having the vaccine, got 2 shots/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Many break outs of shingles) and pain (Verbatim: Hurt). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she was big vaccination advocate but he or she was truly regret on getting the shingles vaccine. The patient stated that he or she been had many break outs of shingles since having the shingles vaccine. The patient was sucked to go through the shingles. The patient reported that he or she received two doses of Shingles vaccine over the past four months and shingles hurts. 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot, still got Shingles/Suspected vaccination failure; Still got 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: Got the shot, still got Shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still got 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 Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I've had shingles and I've had the vaccine; I've had shingles; All pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I've had shingles and I've had the vaccine) (serious criteria GSK medically significant), shingles (Verbatim: I've had shingles) and pain (Verbatim: All pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Apr-2023 Shingles hurt (no itch).  The vaccine was just awful too.  The patient would not do it again. No itch, all pain. The patient had shingles and had the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Paraesthesia
Clinical narrative: Rib area painful,  cage & sternum pain; tingling; This non-serious case was reported by a consumer and described the occurrence of musculoskeletal chest pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included levothyroxine and lovastatin.   On 20-MAR-2023, the patient received Shingrix. On 25-MAR-2023, 5 days after receiving Shingrix and an unknown time after starting levothyroxine, the patient experienced musculoskeletal chest pain (Verbatim: Rib area painful,  cage & sternum pain) and tingling (Verbatim: tingling). On 04-APR-2023, the outcome of the musculoskeletal chest pain and tingling were resolved (duration 10 days).   It was unknown if the reporter considered the musculoskeletal chest pain and tingling to be related to Shingrix.     It was unknown if the company considered the musculoskeletal chest pain and tingling to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-Apr-2023 The reporter said should he/she get the 2nd vaccine. The patient's rib area was painful enough to take pain relievers. The rib cage and sternum pain and tingling symptoms were not treated. The reporter gave permission to contact.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling
Clinical narrative: Eye swelling; This non-serious case was reported by a pharmacist and described the occurrence of eye swelling in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-JAN-2023, the patient received the 1st dose of Shingrix. On 12-JAN-2023, less than a day after receiving Shingrix, the patient experienced eye swelling (Verbatim: Eye swelling). On 15-JAN-2023, the outcome of the eye swelling was resolved (duration 3 days).   It was unknown if the reporter considered the eye swelling to be related to Shingrix.     It was unknown if the company considered the eye swelling to be related to Shingrix.   Additional Information: GSK receipt date: 01-MAY-2023 This report was submitted via the online direct entry reporting system.  The reporter reported that the patient received first dose of Shingrix and eye swelled up for 2-3 days after.  The pharmacist wanted to see if that was a side effect of vaccine.  The patient was not on GSK program. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Fatigue
Clinical narrative: Fatigue; in bed for 3 days; This non-serious case was reported by a physician and described the occurrence of fatigue in a elderly 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 fatigue (Verbatim: Fatigue) and bedridden (Verbatim: in bed for 3 days). The outcome of the fatigue was not reported and the outcome of the bedridden was resolved (duration 3 days).   The reporter considered the fatigue to be related to Shingles vaccine. It was unknown if the reporter considered the bedridden to be related to Shingles vaccine.     The company considered the fatigue to be related to Shingles vaccine. It was unknown if the company considered the bedridden to be related to Shingles vaccine.   Additional Information: GSK receipt date: 28-APR-2023 The patient self-reported this case, during program on shingles The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: My are is painful where she put it; Aches; Also have a slight flavor; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (only 1 pox on cheek as a kid.).   On 24-MAR-2023, the patient received Shingles vaccine (intramuscular). In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: My are is painful where she put it), pain (Verbatim: Aches) and taste altered (Verbatim: Also have a slight flavor). The outcome of the injection site pain was not resolved and the outcome of the pain and taste altered were not reported.   It was unknown if the reporter considered the injection site pain, pain and taste altered to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, pain and taste altered to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient wife has shingles now. she was in an anti viral med and calamine lotion.  The patient had chicken pox but only 1 pox on his cheek as a kid.  The patient had one shingles shot on Friday.his are was painful where she put it intramuscular also have a slight flavor and aches. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: Arm feels like being hit it with a bat; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25-APR-2023, the patient received the 1st dose of Shingles vaccine. In APR-2023, an unknown time after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: Arm feels like being hit it with a bat). The outcome of the arm discomfort was not reported.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     It was unknown if the company considered the arm discomfort to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-Apr-2023 This case was reported by a patient via interactive digital media. The patient received the first shot of Shingles vaccine on the day before reporting. The patient's arm  was felt like somebody hit it with a baseball bat. The follow up would not possible, as no contact, details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling, shoulder to elbow; Redness, shoulder to elbow; This non-serious case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-APR-2023, the patient received the 1st dose of Shingrix. On 10-APR-2023, 3 days after receiving Shingrix, the patient experienced swelling arm (Verbatim: Swelling, shoulder to elbow) and erythema of extremities (Verbatim: Redness, shoulder to elbow). The outcome of the swelling arm and erythema of extremities were not reported.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.     It was unknown if the company considered the swelling arm and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-APR-2023 The other health professional reported that a 56 year old patient in their practice received her first dose of Shingrix immunization on 7 April 2023.  The patient received the vaccine on a Friday and experienced redness and swelling from her shoulder to her elbow through the following Monday. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number TS425) for prophylaxis.   On 28-FEB-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug. The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number TS425) for prophylaxis.   On 08-FEB-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurt a little on the first day; 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 24-APR-2023, the patient received the 1st dose of Shingles vaccine. On 24-APR-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: Hurt a little on the first day). The patient was treated with paracetamol (Tylenol). The outcome of the pain was 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.   Additional Information: GSK Receipt Date: 28-APR-2023 This case was reported by a patient via interactive digital media. Likewise. The patient was very happy.  The patient also got the vaccine on Monday It hurt a little on the first day, then patient get relieved with Tylenol and the next dose was going to be in June 2023. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurts a lot, secondary symptoms; 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 28-APR-2023, the patient received Shingles vaccine. In APR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Hurts a lot, secondary symptoms). The outcome of the pain was not resolved.   The reporter considered the pain to be related to Shingles vaccine.     The company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 29-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that, the vaccine hurts a lot, he/she received it yesterday and it gave her/him all the secondary symptoms. The patient hope he/she get better soon. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: feeling like I was breaking out; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin breakout in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27-APR-2023, the patient received Shingles vaccine. On 29-APR-2023, 2 days after receiving Shingles vaccine, the patient experienced skin breakout (Verbatim: feeling like I was breaking out). The outcome of the skin breakout was resolved (duration 2 hrs).   It was unknown if the reporter considered the skin breakout to be related to Shingles vaccine.     It was unknown if the company considered the skin breakout to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 30-APR-2023 This case was reported by a patient via interactive digital media. The patient had her/his shot Thursday and Saturday start feeling like he/she was breaking out however two hours later it went away patient not normal. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Vaccine hurts; 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 Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Vaccine hurts). The outcome of the pain was not reported.   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.   Additional Information: GSK receipt date: 29-APR-2023 This case was reported by a patient via interactive digital media. The patient's friend got shingles in her head, it had been 3 years and she was even suffering with that right now and they had to remove a piece of brain. The patient stated that the vaccine hurts but it was very effective. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Influenza like illness, Myalgia
Clinical narrative: So sick; muscles aches; flu like symptoms; 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 31-MAR-2023, the patient received Shingles vaccine. On 31-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced sickness (Verbatim: So sick), muscle pain (Verbatim: muscles aches) and influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the sickness, muscle pain and influenza-like symptoms were not reported.   It was unknown if the reporter considered the sickness, muscle pain and influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the sickness, muscle pain and influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient got the shot on the day of reporting and was so sick with muscles aches and flu like symptoms. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Have had the vaccine and shingles four times/Suspected vaccination failure; Had shingles four times; 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: Have had the vaccine and shingles four times/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had shingles four times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   Additional Information: GSK receipt date: 31-MAR-2023 The case  was received from the patient via interactive digital media. The patient had the vaccine and got shingles four times 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: Limb discomfort
Clinical narrative: little annoying the arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (repeated shingles every year).   In MAR-2023, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: little annoying the arm). The outcome of the arm discomfort was unknown.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.   It was unknown if the company considered the arm discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-APR-2023 This case was reported by a patient via interactive digital media. 2 weeks ago from the day of reporting, he/she got the shingles vaccine and in May the second dose.  The reporter stated that a little annoying the arm nothing else. The patient hoped he/she never had again. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: 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: Sick). 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: 31-MAR-2023 This case was reported by a patient via interactive digital media. The reporter report that, shingles was tough. but he/she got medication and she/he got through it. No vaccine for her/him. The reporter stated that, do we know the long term side effects. is it like the Covid jab and you will get Covid anyway. The reporter know a lot of people that got the shingles vaccine and got really sick. So reporter don't know which was worse. yes it was pain and no fun for about a week. But reporter got through it.  Every one needs to make the decision what was best for them.  The reporter medication worked, Warm baths with epsom salt were perfect. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Sensitive skin
Clinical narrative: Horrible pain above ear, stil bothers; Sensitive skin and hair; 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 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Horrible pain above ear, stil bothers) and sensitive skin (Verbatim: Sensitive skin and hair). The outcome of the pain was not resolved and the outcome of the sensitive skin was not reported.   It was unknown if the reporter considered the pain and sensitive skin to be related to Shingles vaccine.     It was unknown if the company considered the pain and sensitive skin to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-APR-2023 This case was reported by a patient via interactive digital media. The reporter reported that the patient recently received Shingles vaccine. The patient stated that the vaccine gave him or her horrible pain above the ear and hair and skin was very sensitive. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only one vial was administered; Only one vial was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only one vial was administered) and inappropriate dose of vaccine administered (Verbatim: Only one vial was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 25-Apr-2023 The reporter had question, only one vial was given to patient. The reporter asked whether they need to give the whole new dose. It was reported that Vial 2 was given not 1. No credentials provided and no additional information. The reporter stated that only one vial, Vial 2 was given not 1 which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only received one vial of the Menveo two-vial presentation; only received one vial of the Menveo two-vial presentation; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only received one vial of the Menveo two-vial presentation) and inappropriate dose of vaccine administered (Verbatim: only received one vial of the Menveo two-vial presentation). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-APR-2023 The reporter was medical assistant. The reporter reported that the patient only received one vial of the Menveo two-vial presentation.  The chat was disconnected before consent was asked. The patient only received one vial of the Menveo two-vial presentation, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: adult received Hiberix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 61-year-old female patient who received Hib (Hiberix) (batch number 9X2TS, expiry date 30-DEC-2023) for prophylaxis.   In DEC-2022, the patient received the 1st dose of Hiberix. In DEC-2022, an unknown time after receiving Hiberix, the patient experienced inappropriate age at vaccine administration (Verbatim: adult received Hiberix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 26-APR-2023 The pharmacy manager called in to ask for information about the possibility of administering Hiberix to an immunocompromised patient who received first dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. An adult patient received Hiberix which led to inappropriate age at vaccine administration.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: Red bumps; several small swollen bumps; Chills; Fatigue; Body aches; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-APR-2023, the patient received the 2nd dose of Shingrix (right arm). On 26-APR-2023, 1 days after receiving Shingrix, the patient experienced chills (Verbatim: Chills), fatigue (Verbatim: Fatigue), general body pain (Verbatim: Body aches) and headache (Verbatim: Headache). On 27-APR-2023, the patient experienced red rash (Verbatim: Red bumps) and swelling (Verbatim: several small swollen bumps). The outcome of the chills, fatigue and general body pain were resolved and the outcome of the headache was resolving and the outcome of the red rash was not resolved and the outcome of the swelling was not reported.   It was unknown if the reporter considered the chills, fatigue, general body pain, headache, red rash and swelling to be related to Shingrix.     It was unknown if the company considered the chills, fatigue, general body pain, headache, red rash and swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-APR-2023 The patient self-reported this case. On 27-APR-2023, 2 days after receiving Shingrix the patient experienced localized erythema and local swelling  The patient received Shingrix and experienced chills, fatigue, headache, and bodyaches.   The patient reported that he noticed several small, red, and swollen bumps on her left wrist, the bumps were not tender to the touch, but do appear to be getting redder as time progressed. The patient reported that she wore their fitness band on that wrist, but never having any type of issue with redness, swelling or bumps from wearing the fitness band.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Swelling
Clinical narrative: Red bumps; several small swollen bumps; Chills; Fatigue; Body aches; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-APR-2023, the patient received the 2nd dose of Shingrix (right arm). On 26-APR-2023, 1 days after receiving Shingrix, the patient experienced chills (Verbatim: Chills), fatigue (Verbatim: Fatigue), general body pain (Verbatim: Body aches) and headache (Verbatim: Headache). On 27-APR-2023, the patient experienced red rash (Verbatim: Red bumps) and swelling (Verbatim: several small swollen bumps). The outcome of the chills, fatigue and general body pain were resolved and the outcome of the headache was resolving and the outcome of the red rash was not resolved and the outcome of the swelling was not reported.   It was unknown if the reporter considered the chills, fatigue, general body pain, headache, red rash and swelling to be related to Shingrix.     It was unknown if the company considered the chills, fatigue, general body pain, headache, red rash and swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-APR-2023 The patient self-reported this case. On 27-APR-2023, 2 days after receiving Shingrix the patient experienced localized erythema and local swelling  The patient received Shingrix and experienced chills, fatigue, headache, and bodyaches.   The patient reported that he noticed several small, red, and swollen bumps on her left wrist, the bumps were not tender to the touch, but do appear to be getting redder as time progressed. The patient reported that she wore their fitness band on that wrist, but never having any type of issue with redness, swelling or bumps from wearing the fitness band.