chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; ROTATEQ that experienced temperature excursion was administered.; This spontaneous report was received from a medical assistant  referring to a specific patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 17-NOV-2023, the patient was vaccinated with oral rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1965569, expiration date on 18-SEP-2024, for prophylaxis (that experienced temperature excursion on 02-NOV-2023) (dose was not reported). The temperature was above 9 Celsius degrees (9.0C) for 0 hours 6 minutes and 0 seconds, and there was no previous temperature excursion. No additional details were provided. No additional adverse event was reported and there was no product quality complaint.  This is one of 10 reports from the same reporter.; Sender's Comments:  US-009507513-2311USA008457: US-009507513-2311USA008583: US-009507513-2311USA008586: US-009507513-2311USA008588: US-009507513-2311USA008565: US-009507513-2311USA008448: US-009507513-2311USA008473: US-009507513-2311USA008441: US-009507513-2311USA008709:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller is a medical assistant who reports ROTATEQ that experienced temperature excursion was administered; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 02-NOV-2023, a rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral liquid, experienced a temperature excursion, with a timeframe of 6 minutes at a temperature of above 9 degree Celsius (C), prior to being administered to the patient on 06-NOV-2023 (product storage error), (lot number 1965569 has been determined to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) with an expiration date established as 18-SEP-2024), administered orally for prophylaxis (strength and dose were not provided). No additional adverse events were reported for this patient.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2311USA008565:02512267 US-009507513-2311USA008457:02512245 US-009507513-2311USA008588:02512265 US-009507513-2311USA008448:02512272 US-009507513-2311USA008586:02512274 US-009507513-2311USA008583:02512275 US-009507513-2311USA008473:02512276 US-009507513-2311USA008441:02512283
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Received Heplisav-B While Pregnant; Initial report received on 18-Sep-2023.  A patient reported to the pregnancy registry that a female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while the patient was pregnant.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 28-Aug-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC number, route and site not reported).   The patient reported receiving her first dose of Heplisav-B while pregnant. Her EDD was 10-Jan-2024.  No additional information was reported.   Company Comment: The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Received Heplisav-B While 10 Weeks Pregnant; Initial report received on 20-Sep-2023  A registered nurse reported that a 29-year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization when she was 10 weeks pregnant.  Medical history, allergies, and concomitant medications at the time of vaccination were not reported.   On 18-Aug-2023, the patient received the first dose of HEPLISAV-B (Lot # 941428, expiration date 30- Apr-2025, NDC # 43528-003-05; injection site not reported) intramuscularly. It was discovered later that the patient was 10-weeks pregnant at the time of the injection. The patient's last menstrual period, estimated date of delivery, pregnancy history, and pregnancy risk factors were not reported.  No other information was available.  Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccinated and still got shingles/ Suspected Vaccination failure; 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: vaccinated and still got shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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: 21-NOV-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had been vaccinated and still got shingles. 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure/now has shingles; Shingles; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In NOV-2023, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/now has shingles) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pain was 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: 21-NOV-2023 The case was received from the patient's wife interactive digital media. The patient got vaccinated a couple of years ago and now had shingles on his head and neck (at the time of reporting) and was diagnosed this past week.  The pain was bad but, it could be worse.  The anti-viral medicines seems to had stopped the spread.  The reporter stead that, just like the flu vaccine, you could still get It just less severe case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got Shingles; Sick; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got Shingles) and sickness (Verbatim: Sick). The outcome of the vaccination failure was unknown and the outcome of the shingles and sickness were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-NOV-2023 The case was received from the patient interactive digital media. The patient stated that his/her general practitioner (GP) told him/her did not get the shingles vaccine.  The patient did and it made him sick and got shingles. 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, Vaccination failure
Clinical narrative: Suspected vaccination failure; Nope got the vaccine, 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Nope got the vaccine, got shingles!). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-NOV-2023 This case was reported by a patient via interactive digital media. The reporter was patient. The reporter reported that nope got the vaccine, got shingles. 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Did the vaccine have had shingles/ 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: Did the vaccine have had shingles/ 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: 21-Nov-2023 This case was reported by a patient via interactive digital media. The patient received Shingles vaccine and experienced shingles three times. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Post herpetic pain; Sick; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 94-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), post herpetic neuralgia (Verbatim: Post herpetic pain) and sickness (Verbatim: Sick). The outcome of the vaccination failure was unknown and the outcome of the shingles and sickness were not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and sickness to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-Nov-2023 This case was reported by a patient's wife via interactive digital media. The reporter reported that her husband had Shingles for 13 years.  Now it was called post herpetic neuralgia for nerve pain.  Patient was in pain 24 by 7. The patient was sick as a dog. The reporter stated if you can see him just one day how he suffers, you would cry.  The reporter did not even had tears anymore, she cry for so much.  The patient is 94 years old now. He was 81 when he got shingles and did not received medication for it. 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. Follow-up would not possible as no contact details were available. This case has been linked to the US2023AMR162894 case reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR162894:wife case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: still got the shingles/Suspected vaccination faillure; still got the shingles; still have pain; itching; 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: still got the shingles/Suspected vaccination faillure) (serious criteria GSK medically significant), shingles (Verbatim: still got the shingles), pain (Verbatim: still have pain) and pruritus (Verbatim: itching). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain and pruritus were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-Nov-2023 The case was received from the patient via interactive digital media. The patient had the best vaccination there was and still got the shingles.  2 years later, the patient still had pain and itching. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Made my outbreaks so much worse; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Made my outbreaks so much worse). The outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-NOV-2023 This case was reported by a patient via interactive digital media. The reporter was patient. The reporter reported that don't do it,  The vaccine made his/her outbreaks so much worse, the biggest mistake he/she ever made. 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. Follow-up not per process as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Auditory disorder, Meniere's disease, Rash
Clinical narrative: men meniers disease; Loading my hearing; This serious case was reported by a consumer via interactive digital media and described the occurrence of meniere's disease 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 meniere's disease (Verbatim: men meniers disease) (serious criteria GSK medically significant) and auditory disorder (Verbatim: Loading my hearing). The outcome of the meniere's disease and auditory disorder were not reported.   It was unknown if the reporter considered the meniere's disease and auditory disorder to be related to Shingles vaccine.     It was unknown if the company considered the meniere's disease and auditory disorder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-Nov-2023 This case was reported by a patient via interactive digital media. The patient reported that the rash was far better than the side effects of the vaccine.  The patient received Shingles vaccine and experienced loading his or her hearing and developing men meniers disease had left him or her questioning any vaccine. This vaccine was not safe. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: RVX
Symptoms: Injection site cellulitis, Injection site induration, Injection site scab, Peripheral swelling
Clinical narrative: scabbing of site; looked initially as a cellulitis but continues with ongoing induration and scabbing of site; looked initially as a cellulitis but continues with ongoing induration and scabbing of site; swelling of arm; This non-serious case was reported by a other health professional and described the occurrence of injection site scab in a 76-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number MZ735, expiry date 21-MAR-2025) for prophylaxis.   Concurrent medical conditions included breast cancer (breast CA), hypertension (HTN), hodgkin's lymphoma (HL) and chronic obstructive pulmonary disease (COPD).   On 19-OCT-2023, the patient received RSV vaccine (intramuscular) .5 ml. On 22-OCT-2023, 3 days after receiving RSV vaccine, the patient experienced swelling arm (Verbatim: swelling of arm). On an unknown date, the patient experienced injection site scab (Verbatim: scabbing of site), injection site induration (Verbatim: looked initially as a cellulitis but continues with ongoing induration and scabbing of site) and injection site cellulitis (Verbatim: looked initially as a cellulitis but continues with ongoing induration and scabbing of site). The outcome of the injection site scab, injection site induration and swelling arm were not resolved and the outcome of the injection site cellulitis was not reported.   It was unknown if the reporter considered the injection site scab, injection site induration, injection site cellulitis and swelling arm to be related to RSV vaccine.   It was unknown if the company considered the injection site scab, injection site induration, injection site cellulitis and swelling arm to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 16-NOV-2023 This report was submitted via the online direct entry reporting system. The patient received RSV vaccine. The patient stated that it looked initially as a cellulitis but continued with ongoing induration and scabbing of site. The photo documentation done by patient. The patient also continued with multiple medications. The swelling of arm was treated. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: a lot of fatigue; no energy; At the site of injection was soreness; At the site of injection was swelling; stomach cramps; heaving; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-NOV-2023, the patient received the 1st dose of Shingrix. On 14-NOV-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: At the site of injection was soreness), injection site swelling (Verbatim: At the site of injection was swelling), stomach cramps (Verbatim: stomach cramps) and retching (Verbatim: heaving). On 15-NOV-2023, the patient experienced fatigue (Verbatim: a lot of fatigue) and loss of energy (Verbatim: no energy). On 17-NOV-2023, the outcome of the injection site pain and injection site swelling were resolved and the outcome of the stomach cramps and retching were resolved (duration 3 days) and the outcome of the fatigue and loss of energy were resolved (duration 2 days).   It was unknown if the reporter considered the injection site pain, injection site swelling, stomach cramps, retching, fatigue and loss of energy to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, stomach cramps, retching, fatigue and loss of energy to be related to Shingrix.   Additional Information: GSK receipt date: 17-Nov-2023 The patient stated that she received the 1st Shingrix vaccine shot and at the site of injection was soreness and swelling.  Caller stated that within 12 hours she was having stomach cramps and heaving.  The patient stated that the next day she had no energy and a lot of fatigue and that afternoon she again had stomach cramps, heaving, no energy and fatigue.  The patient stated that she was back to normal on the day of reporting.  No further information provided. No batch number/lot number was provided to the patient by pharmacy. The reporter consented to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Retching
Clinical narrative: a lot of fatigue; no energy; At the site of injection was soreness; At the site of injection was swelling; stomach cramps; heaving; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-NOV-2023, the patient received the 1st dose of Shingrix. On 14-NOV-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: At the site of injection was soreness), injection site swelling (Verbatim: At the site of injection was swelling), stomach cramps (Verbatim: stomach cramps) and retching (Verbatim: heaving). On 15-NOV-2023, the patient experienced fatigue (Verbatim: a lot of fatigue) and loss of energy (Verbatim: no energy). On 17-NOV-2023, the outcome of the injection site pain and injection site swelling were resolved and the outcome of the stomach cramps and retching were resolved (duration 3 days) and the outcome of the fatigue and loss of energy were resolved (duration 2 days).   It was unknown if the reporter considered the injection site pain, injection site swelling, stomach cramps, retching, fatigue and loss of energy to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, stomach cramps, retching, fatigue and loss of energy to be related to Shingrix.   Additional Information: GSK receipt date: 17-Nov-2023 The patient stated that she received the 1st Shingrix vaccine shot and at the site of injection was soreness and swelling.  Caller stated that within 12 hours she was having stomach cramps and heaving.  The patient stated that the next day she had no energy and a lot of fatigue and that afternoon she again had stomach cramps, heaving, no energy and fatigue.  The patient stated that she was back to normal on the day of reporting.  No further information provided. No batch number/lot number was provided to the patient by pharmacy. The reporter consented to follow-up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: site of injection was a large red swollen spot; site of injection was a large red swollen spot; fatigue; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site swelling in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-NOV-2023, the patient received the 1st dose of Shingrix. On 14-NOV-2023, less than a day after receiving Shingrix, the patient experienced injection site swelling (Verbatim: site of injection was a large red swollen spot), injection site erythema (Verbatim: site of injection was a large red swollen spot) and fatigue (Verbatim: fatigue). On 17-NOV-2023, the outcome of the injection site swelling, injection site erythema and fatigue were resolved (duration 3 days).   It was unknown if the reporter considered the injection site swelling, injection site erythema and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site erythema and fatigue to be related to Shingrix.   Additional Information: GSK receipt date: 17-NOV-2023 This report was submitted via Resource Center. The case was reported by the wife of the patient. The reporter stated that the patient received the 1st Shingrix vaccine shot and experienced large red swollen spot at the site of injection, that as of today (on the day of reporting) was gone.  The reporter further stated that the patient was having fatigue until today. The batch/lot number not provided by pharmacy. No further information provided. The consent to follow up requested.
Sex: F
Vaccine: RVX
Symptoms: Abdominal distension, Fluid retention
Clinical narrative: severe bloating; water weight fluid retention; This non-serious case was reported by a consumer and described the occurrence of bloating in a 77-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 24-OCT-2023, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced bloating (Verbatim: severe bloating) and fluid retention (Verbatim: water weight fluid retention). The outcome of the bloating and fluid retention were resolved (duration 3 weeks).   It was unknown if the reporter considered the bloating and fluid retention to be related to RSV vaccine.     It was unknown if the company considered the bloating and fluid retention to be related to RSV vaccine.   Additional Information: GSK Receipt date: 17-NOV-2023 The patient stated that she felt like she was carrying around five pounds of water weight fluid retention and had severe bloating lasting for three weeks past vaccination. The reporter consented to follow up via mail.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: vaccine gave me the shinlges; This non-serious case was reported by a consumer and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-NOV-2021, the patient received Shingrix. On 05-NOV-2021, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: vaccine gave me the shinlges). The patient was treated with acyclovir and lysine. The outcome of the shingles was not resolved.   The reporter considered the shingles to be related to Shingrix.     The company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt date: 21-NOV-2023 The reporter was a patient. The reporter reported that she had recurring Shingles once a month since she received vaccine. Patient reported that to the reporting time that she had to take Acyclovir and Lysine to try to control the poison from the Shingrix vaccine on a daily basis to try to function. The reporter requested to consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: forgot to take 2nd dose; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: forgot to take 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 19-NOV-2023 It was reported that patient only took one Shingrix over a year ago and forgot to take 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: delayed swelling; This non-serious case was reported by a consumer and described the occurrence of swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced swelling (Verbatim: delayed swelling). The outcome of the swelling was not reported.   It was unknown if the reporter considered the swelling to be related to Shingrix.     It was unknown if the company considered the swelling to be related to Shingrix.   Additional Information: GSK Receipt Date-17-NOV-2023 The patient had delayed swelling after Shingrix 2 weeks later.
Sex: U
Vaccine: RSV
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: I had a very sore arm; I have a purplish brown mark on the outside of the left corner of my eye; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number LL942, expiry date 23-MAR-2025) for prophylaxis.   Co-suspect products included Influenza vaccine (batch number U813DA, expiry date 30-JUN-2024) for prophylaxis.   On 06-NOV-2023 11:00, the patient received Arexvy (left arm). On 22-OCT-2023, the patient received Influenza vaccine. On 06-NOV-2023, less than a day after receiving Arexvy, the patient experienced pain in arm (Verbatim: I had a very sore arm) and eye color change (Verbatim: I have a purplish brown mark on the outside of the left corner of my eye). The outcome of the pain in arm and eye color change were unknown.   It was unknown if the reporter considered the pain in arm and eye color change to be related to Arexvy.     It was unknown if the company considered the pain in arm and eye color change to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-NOV-2023 The patient received the RSV vaccine on Monday, 6th November 2023. The patient received unspecified Flu shot. The reporter stated that besides developing a really sore arm something else happened. The patient had a purple/brown spot under the left corner of eye that was not there before he/she had the shot and he/she had the shot at 11 A.M. and by dinner time, 8 hours after RSV vaccine that problem was there. The patient stated that it looked like someone punched him/her near the eye or he/she walked into a wall, it did not hurt.  The reporter mentioned, none of the doctors he/she seen seem overly concerned about it and he/she asked, but what happened, would that go away. The reporter just documenting what happened to him/her, he/she would be on the phone and emailing his/her allergist, trying to get an appointment with an eye doctor. The patient's eye doctor would going on vacation next week so that probably won't happen until the following week but not in pain with it, it was just unsightly. It was unknown if the reporter considered the pain in arm and eye color change to be related to Influenza vaccine. The consumer hung up the call abruptly. Further probing could not be done. Permission to contact reporter was unknown as question could not be probed.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: The first one 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 the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: The first one 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.   Linked case(s) involving the same patient:US2023AMR165110   Additional Information: GSK Receipt Date: 20-NOV-2023 This case was reported by a consumer via (social media) interactive digital media. The patient already had Shingles vaccine because it repeated. The reporter stated that it hurt. The follow up would not possible as no contact details were available. For tolerance of 2nd dose of Shingles vaccine, refer case US2023AMR165110.; Sender's Comments:  US-GSK-US2023AMR165110:case for second dose
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: made me feel bad after 1st dose; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included varicella zoster vaccine with an associated reaction of feeling abnormal (received 1st dose on an unknown date, refer case US2023AMR159551) and COVID-19 vaccine (had 3 Covid shots and no more of them).   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 feeling bad (Verbatim: made me feel bad after 1st dose). Rechallenge with Shingles vaccine was positive. The outcome of the feeling bad was not reported.   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:  US2023AMR159551, US2023AMR163503   Additional Information: GSK Receipt Date: 13-NOV-2023 The reporter was patient. The reporter had not a flu shot in 30 years and did not plan to get anymore. The reporter reported that patient received 2nd dose of shingles vaccine and felt bad. The patient stated that it was a good thing he/she did not need any more of that. The RSV shot could make you feel bad too just like the shingles shot and not getting that either. The patient had enough of getting shots that make him/her felt bad. The follow up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR159551:same patient , 1st dose US-GSK-US2023AMR163503:same patient, different product
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received 2 doses of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 62-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4AK57, expiry date 23-MAR-2025) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   On 06-NOV-2023, the patient received the 2nd dose of Arexvy. On 06-NOV-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received 2 doses of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 10-NOV-2023 A pharmacist reported that a patient has received 2 doses of Arexvy, which led to extra dose administered. The reporter asked for safety information regarding this situation. The reporter consented to follow up.  Follow up information received on 16-NOV-2023: The patient received first dose was given on 20th Sep 2023, batch number75BS5 and expiration date 28th Jan 2025. Summary of changes: product tab and Narrative was updated.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Needle attached to prefilled syringe and stored in refrigerator for a week; This non-serious case was reported by a other health professional via sales rep and described the occurrence of wrong technique in product usage process in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced wrong technique in product usage process (Verbatim: Needle attached to prefilled syringe and stored in refrigerator for a week). The outcome of the wrong technique in product usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-Nov-2023 The reporter reported that he attached needle to prefilled syringe and stored in refrigerator for a week, which led to wrong technique in product usage process. The vaccine administration facility was the same as primary reporter. The reporter stated that it was unclear if there had been patient involvement. The reporter did consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pharmacist gave her another Shingrix Vaccination on 11/14/2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received Shingrix vaccine series in approximately late 2018).   On 14-NOV-2023, the patient received the 3rd dose of Shingrix. On 14-NOV-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: pharmacist gave her another Shingrix Vaccination on 11/14/2023). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date:15-NOV-2023 The reporter was a husband calling on behalf of his wife. The reporter stated that wife received the Shingrix vaccine series approximately late 2018. The patient lost vaccine administration record and did not have proof of her Shingrix vaccination in 2018. The pharmacist gave her another Shingrix vaccination on 14-NOV-2023 due to not having previous vaccination record, which led to extra dose administered. The reporter stated that wife had no adverse reaction from third Shingrix vaccination as of present time. The reporter did not consent to follow-up. Reporter would like his wife to call back and give consent for GSK safety to contact her physician.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain, Pyrexia
Clinical narrative: arm red at injection site; arm puffy at injection site; itchy at injection site; fever; achy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: arm red at injection site), injection site swelling (Verbatim: arm puffy at injection site), injection site itching (Verbatim: itchy at injection site), fever (Verbatim: fever) and pain (Verbatim: achy). The outcome of the injection site erythema, injection site swelling, injection site itching, fever and pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching, fever and pain to be related to Shingrix.  It was unknown if the company considered the injection site erythema, injection site swelling, injection site itching, fever and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-NOV-2023 The reporter called when he had Shingrix (date unknown) and experienced a red, itchy and puffy at injection site. The reporter stated that he also had a fever and was achy.  No further information was known. The reporter declined to provide consent or any personal demographics. The reporter did not consent to follow-up.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Cough
Clinical narrative: The patient is experiencing a cough after receiving FLULAVAL; This non-serious case was reported by a consumer via call center representative and described the occurrence of cough in a 20-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2023-2024 season) (batch number 39PF2, expiry date 30-JUN-2024) for prophylaxis.   The patient's past medical history included cancer and partial lung resection.   On 14-NOV-2023, the patient received FluLaval Quadrivalent 2023-2024 season (intramuscular, right deltoid). In NOV-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced cough (Verbatim: The patient is experiencing a cough after receiving FLULAVAL). The outcome of the cough was unknown.   It was unknown if the reporter considered the cough to be related to FluLaval Quadrivalent 2023-2024 season and Flulaval Tetra Pre-Filled Syringe Device.  It was unknown if the company considered the cough to be related to FluLaval Quadrivalent 2023-2024 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-NOV-2023 The reporter was the mother of the patient. The patient was experiencing a cough after receiving Flulaval. The reporter did not consent to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Flu-like symptoms; fatigue; This non-serious case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced influenza-like symptoms (Verbatim: Flu-like symptoms) and fatigue (Verbatim: fatigue). The outcome of the influenza-like symptoms and fatigue were not reported.   It was unknown if the reporter considered the influenza-like symptoms and fatigue to be related to Arexvy.     It was unknown if the company considered the influenza-like symptoms and fatigue to be related to Arexvy.   Additional Information: GSK Receipt date: 16-NOV-2023 It was reported that if any information gathered on Arexvy and Covid vaccines as far as side effects.  The patient that had experienced some major side effects such as flu-like, fatigue.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Syringe issue, Underdose
Clinical narrative: administration of incomplete dose; This non-serious case was reported by a physician via call center representative and described the occurrence of accidental underdose in a 15-year-old male patient who received HAV (Havrix) for prophylaxis.   On 16-NOV-2023, the patient received Havrix. On 16-NOV-2023, an unknown time after receiving Havrix, the patient experienced accidental underdose (Verbatim: administration of incomplete dose). The outcome of the accidental underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 16-NOV-2023 The doctor reported that a nurse administered a dose of Havrix and the vaccine leaked administrating approximately half of the dose which lead to accidental underdose. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. No lot number or expiration date provided.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: received the 1st dose of Shingrix on 13Nov2020, 2nd dose on 14Jan2021, an accidental 3rd dose on 08Apr2022 and an accidental 4th Dose on 08Sep2023; received the 1st dose of Shingrix on 13Nov2020, 2nd dose on 14Jan2021, an accidental 3rd dose on 08Apr2022 and an accidental 4th Dose on 08Sep2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number Y227N, expiry date 25-OCT-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th November 2020) and Shingrix (received 2nd dose on 14th January 2021).   On 08-SEP-2023, the patient received the 4th dose of Shingrix. On 08-APR-2022, the patient received the 3rd dose of Shingrix. On 08-APR-2022, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received the 1st dose of Shingrix on 13Nov2020, 2nd dose on 14Jan2021, an accidental 3rd dose on 08Apr2022 and an accidental 4th Dose on 08Sep2023). On 08-SEP-2023, the patient experienced extra dose administered (Verbatim: received the 1st dose of Shingrix on 13Nov2020, 2nd dose on 14Jan2021, an accidental 3rd dose on 08Apr2022 and an accidental 4th Dose on 08Sep2023). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK receipt date: 16-NOV-2023 The pharmacist reported that a patient received the 1st dose, 2nd dose, an accidental 3rd dose and an accidental 4th Dose.  The health care professional (HCP) stated that the patient reported that he was feeling fine. Accidentally the patient received 2 extra Shingrix dose, which led to extra dose administered The reporter consented to follow up via email.