chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Neoplasm, Vaccination failure
Clinical narrative: Unknown cause of death; Shot gave her shingles/ Suspected vaccination failure; Shingles; Tumor; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Unknown cause of death) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Shot gave her shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and neoplasm (Verbatim: Tumor).  The outcome of the vaccination failure was unknown and the outcome of the shingles and neoplasm were not reported. The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. The reporter considered the vaccination failure, shingles and neoplasm to be related to Shingles vaccine.     It was unknown if the company considered the unknown cause of death to be related to Shingles vaccine. The company considered the vaccination failure, shingles and neoplasm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient's friend via interactive digital media. The reporter reported that the patient's who take vaccines and are lots of prescription drugs end up with skin afflictions.  The reporter stated that the heavy metals did not metabolize naturally in the body.  The reporter reported that Vaers gov or open Vaers vaccine adverse events report system Over 600,000 reported deaths due to Covid vaccine trash vaccines cause the afflictions observe.  The reporter reported that his or her friend died 4 months after received shingles vaccine.  The shingles vaccine gave her shingles and a tumor. 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.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles from the vaccine/Suspected vaccination failure; I got shingles from the vaccine; 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: I got shingles from the vaccine/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles from the vaccine).The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   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: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient got shingles from the shingles vaccine. The patients doctor said it was not possible until he/she sent her a picture of it.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles on my right leg from above my knee and it runs all the way to my ankle; extremely painful; Extra dose administered; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Shingles vaccine. On an unknown date, an unknown time after receiving Shingrix, Shingrix and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles on my right leg from above my knee and it runs all the way to my ankle), pain (Verbatim: extremely painful) and extra dose administered (Verbatim: Extra dose administered).  The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix, Shingrix and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingrix, Shingrix and Shingles vaccine.   Additional Information: GSK receipt date 18-SEP-2023 This case was reported by the patient via interactive digital media. The patient got the first shingles shot when it first came out . Then took the two Shingrix shots a few years ago.  The patient asked to guess what he/ she was having now(the recent time). The physician said of have a very bad case of shingles on right leg from above my knee and it run all the way to the ankle.  It was extremely painful and the patient was going to be 81 next month. The patient's 85 year old sister, cousin in his 70's , and pastor just got their . The patient received 3 doses of shingles vaccine, which led to extra dose administered. 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 could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Get the shot then get 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 an unspecified number of patient's 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: Get the shot then get 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: 17-SEP-2023 This case was reported by a patient's friend via interactive digital media. The reporter reported that his or her friends received the shingles vaccine and experienced 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: M
Vaccine: RVX
Symptoms: Heart rate increased, Myalgia, Palpitations, Pyrexia
Clinical narrative: Palpitations; rapid heart rate; fever; severe muscle pain; This non-serious case was reported by a consumer and described the occurrence of palpitation in a 68-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 15-SEP-2023, the patient received RSV vaccine. On 15-SEP-2023, less than a day after receiving RSV vaccine, the patient experienced palpitation (Verbatim: Palpitations), heart rate increased (Verbatim: rapid heart rate), fever (Verbatim: fever) and muscle pain (Verbatim: severe muscle pain). The outcome of the palpitation, heart rate increased, fever and muscle pain were not resolved.   It was unknown if the reporter considered the palpitation, heart rate increased, fever and muscle pain to be related to RSV vaccine.     It was unknown if the company considered the palpitation, heart rate increased, fever and muscle pain to be related to RSV vaccine.   Additional Information: GSK receipt date: 15-Sept-2023 The patient received RSV vaccine and had palpitations, rapid heart rate, fever and muscle pain. The symptoms were not treated. The reporter consented to follow-up.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Boostrix was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number BR352, expiry date 27-AUG-2022) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: expired dose of Boostrix was administered to a patient).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-SEP-2023 The pharmacist called and reported an expired dose of Boostrix was administered to a patient which led to expired vaccine used. At the moment of the call reporter did not had any information about the patient or vaccination date. The reporter did not consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in arm in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included pain in arm. Previously administered products included Flu shot (received flu shot on an unknown date).   On an unknown date, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arm).  The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 15-Sept-2023 The patient received a dose of Arexvy  and had no side effects other than a sore arm, less than or comparable to a flu shot. The reporter denied to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Mobility decreased
Clinical narrative: had no energy; was tired; she noticed it was harder to move; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of loss of energy in a 50-year-old female 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 loss of energy (Verbatim: had no energy), tiredness (Verbatim: was tired) and mobility decreased (Verbatim: she noticed it was harder to move).  The outcome of the loss of energy, tiredness and mobility decreased were not reported.   It was unknown if the reporter considered the loss of energy, tiredness and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the loss of energy, tiredness and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK receipt date: 15-Sept-2023 The patient received 2nd dose of Shingle vaccine and felt like crap. The patient was also tired, had no energy and noticed that it was harder to move.
Sex: U
Vaccine: FLUX, RVX
Symptoms: Headache, Malaise
Clinical narrative: Felt kind of icky rest of day; headache; This non-serious case was reported by a other health professional via interactive digital media and described the occurrence of malaise in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 13-SEP-2023, the patient received RSV vaccine and INFLUENZA VACCINE. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced malaise (Verbatim: Felt kind of icky rest of day) and headache (Verbatim: headache).  In SEP-2023, the outcome of the malaise and headache were resolved.   It was unknown if the reporter considered the malaise and headache to be related to RSV vaccine.     It was unknown if the company considered the malaise and headache to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 15-SEP-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she worked with that nasty virus for 20 years in a psychiatric intensive care unit.  We hated RSV season with a passion. The patient stated that thankfully though he or she was retired almost six years now, Respiratory Therapy came a long way for these kids.  Vapotherm or high flow nasal cannula kept many, many kids off of the ventilator. The reporter received his or her flu or RSV vaccinations on 13th September 2023.  The patient woke up with a headache, then felt kind of icky rest of day.  The patient did not took anything so as to not affect the immune response. The patient was felt great on the day of reporting. It was unknown if the reporter considered the malaise and headache to be related to Influenza vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: super sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: super 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 18 Sep 2023 This case was reported by a consumer via interactive digital media. The patient was super sick after having vaccine. The patient assumed it was better than the shingles though.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Myalgia
Clinical narrative: deep muscular sore; dizziness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-APR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced muscle soreness (Verbatim: deep muscular sore) and dizziness (Verbatim: dizziness).  The outcome of the muscle soreness and dizziness were not reported.   The reporter considered the muscle soreness and dizziness to be related to Shingrix.     The company considered the muscle soreness and dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-SEP-2023 This case was reported the patient via interactive digital media. The patient got the 1st shot and would be leaving the country last September and could not got 2nd shot until late October and if it was ok. The patient play competitive golf and had shot gave the patient deep muscular sore and dizziness.  The patient also getting on Cruise ships, so wanted to delay shot until returned to country. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: I got the first vaccine and it is very painful; sweat; feverish; 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 17-SEP-2023, the patient received the 1st dose of Shingles vaccine. In SEP-2023, several hours after receiving Shingles vaccine, the patient experienced pain (Verbatim: I got the first vaccine and it is very painful), sweating (Verbatim: sweat) and fever (Verbatim: feverish). The outcome of the pain was not resolved and the outcome of the sweating and fever were not reported.   It was unknown if the reporter considered the pain, sweating and fever to be related to Shingles vaccine.   It was unknown if the company considered the pain, sweating and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-SEP-2023 This case was reported by a patient via interactive digital media. The reporter stated that he/she got the shingles vaccine just yesterday (the day before reporting) and it was very painful after a few hours. The patient was still suffering the effects of the pain.  The reporter wanted to know if this was normal or he/she was very delicate. The patient still not had the other dose, he/she even felt feverish and really sweaty.
Sex: U
Vaccine: FLUX, RVX
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 14-SEP-2023, the patient received RSV vaccine and INFLUENZA VACCINE. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Sore arm).The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt date: 15-SEP-2023 and 18-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that he or she got the RSV and the flu shot together yesterday.  No side effects just a really sore arm. It was unknown if the company considered the pain in arm to be related to Flu vaccine.  Follow up was not possible, as no contact, details were available.
Sex: U
Vaccine: FLUX, PPV, RVX
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Pretty tired; sore arms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and INFLUENZA VACCINE for prophylaxis.   On 15-SEP-2023, the patient received RSV vaccine, PNEUMONIA VACCINE and INFLUENZA VACCINE. In SEP-2023, less than a week after receiving RSV vaccine, the patient experienced tiredness (Verbatim: Pretty tired) and pain in arm (Verbatim: sore arms).  In SEP-2023, the outcome of the tiredness and pain in arm were resolved (duration 2 days).   It was unknown if the reporter considered the tiredness and pain in arm to be related to RSV vaccine.     It was unknown if the company considered the tiredness and pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt date: 17-SEP-2023 and 18-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that he or she got flu, pneumonia and RSV shot on Friday.  The patient was pretty tired and sore arms the first two days otherwise no problems. It was unknown if the reporter considered the tiredness and pain in arm to be related to Flu and Pneumonia vaccine.    Follow up was not possible, as no contact, details were available.
Sex: F
Vaccine: RSV
Symptoms: Erythema, Swelling
Clinical narrative: swelling; redness; This non-serious case was reported by a nurse via sales rep and described the occurrence of swelling in a female 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 swelling (Verbatim: swelling) and erythema (Verbatim: redness). The outcome of the swelling and erythema were not reported.   It was unknown if the reporter considered the swelling and erythema to be related to Arexvy.     It was unknown if the company considered the swelling and erythema to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-SEP-2023 The nurse practitioner stated after getting the Arexvy vaccine patient experienced swelling and redness. The reporter did not consented to followup.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot should hurt for that many days; 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 11-SEP-2023, the patient received the 2nd dose of Shingles vaccine. In SEP-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shot should hurt for that many days).The outcome of the pain was resolving.   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: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient had his/her Shingles shot last Monday. The reporter stated that today was Saturday and the pain was almost gone. The reporter could not believe a shot should hurt for that many days.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Movement disorder, Pain, Swelling
Clinical narrative: Painful; Red; Swollen; Could not bend my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 77-year-old 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: Painful), erythema (Verbatim: Red), swelling (Verbatim: Swollen) and movement disorder (Verbatim: Could not bend my arm). The outcome of the pain, erythema, swelling and movement disorder were resolved (duration 4 days).   It was unknown if the reporter considered the pain, erythema, swelling and movement disorder to be related to Shingles vaccine.     It was unknown if the company considered the pain, erythema, swelling and movement disorder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine at age of 62 years and now he or she was 77 years old and fortunately he or she did not had shingles. The reporter reported that he or she was glad for received shingles vaccine but it was most painful afterwards. The patient experienced pain, red, swollen and could not bend his or her arm for four days. The reporter stated that he or she never had a reaction like that with any vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEP
Symptoms: Therapeutic response decreased
Clinical narrative: Reduced immune response; This non-serious case was reported by a physician via sales rep and described the occurrence of therapeutic response decreased in an unspecified numbers of patients who received Hepatitis B vaccine for prophylaxis.   Concurrent medical conditions included hiv infection.   On an unknown date, the patients received Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patients experienced therapeutic response decreased (Verbatim: Reduced immune response). The outcome of the therapeutic response decreased was unknown.   Additional Information: GSK receipt date: 15-Sep-2023 The reporter reported that they were double vaccinating HIV patients with the HBV vaccine due to observed reduced immune response in the patient's population. The reporter did not agreed to follow up. The patients had reduced immune response after Hepatitis B vaccination, which led to therapeutic response decreased.
Sex: M
Vaccine: RSV
Symptoms: Intercepted product prescribing error
Clinical narrative: prescription of Arexvy to patient under 60 years; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: prescription of Arexvy to patient under 60 years).  The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 15-Sep-2023 The pharmacist requested data on the use of Arexvy for a patient under the age of 60. Pharmacist stated that the MD had sent a prescription for the patient under 60 years of age to receive the Arexvy vaccine which led to intercepted drug prescribing error. Arexvy not administered at time of call. The reporter did not consent to follow up. Pharmacist declined Safety team follow up. No patient demographics available.
Sex: F
Vaccine: MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: Priorix administered on same day as Proquad; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 12-month-old female patient who received MMR (Priorix) (batch number 3247X, expiry date 11-MAY-2024) for prophylaxis.   Co-suspect products included PROQUAD for prophylaxis.   On 15-SEP-2023, the patient received Priorix and PROQUAD. On 15-SEP-2023, an unknown time after receiving Priorix, the patient experienced overdose (Verbatim: Priorix administered on same day as Proquad).  The outcome of the overdose 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: 15-Sep-2023 A Medical Assistant called to inform that a patient received a dose of Priorix, and on the same day also was administered a dose of Proquad which led to overdose. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 65.0
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 8.10.2022, 2nd dose on 15.9.2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old patient who received HAB (Twinrix) (batch number 327E3, expiry date 14-MAY-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 08 October 2022).   On 15-SEP-2023, the patient received the 2nd dose of Twinrix. On 15-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 8.10.2022, 2nd dose on 15.9.2023).  The outcome of the drug dose administration interval too long 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: 15-SEP-2023 The pharmacist called to inquire regarding how to proceed with the Twinrix Series. The healthcare professional reported that they had patients who received their second dose of Twinrix late. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The reporter did not consent to follow up. The case is linked with US2023127574, same reporter.; Sender's Comments:  US-GSK-US2023127574:Second patient
Age: 68.0
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received their second dose of Twinrix late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old patient who received HAB (Twinrix) (batch number 327E3, expiry date 14-MAY-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 06 May 2023).   On 15-SEP-2023, the patient received Twinrix. On 15-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received their second dose of Twinrix late).  The outcome of the drug dose administration interval too long 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: 15-SEP-2023 The pharmacist called to inquire regarding how to proceed with the Twinrix Series. The healthcare professional reported that they had patients who received their second dose of Twinrix late. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The reporter did not consent to follow up. The case is linked with US2023127573, same reporter.; Sender's Comments:  US-GSK-US2023127573:Second patient
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Skin warm
Clinical narrative: painful hot spots on his right arm and back; hot spots; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 10-MAR-2022, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 01-SEP-2023, 540 days after receiving Shingrix, the patient experienced pain (Verbatim: painful hot spots on his right arm and back) and skin warm (Verbatim: hot spots).  The outcome of the pain and skin warm were not resolved.   The reporter considered the pain and skin warm to be possibly related to Shingrix.     The company considered the pain and skin warm to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 15-SEP-2023 The patient self-reported this case. The patient received his first Shingrix vaccine on 10th January 2022  in an unknown arm and the second dose of Shingrix vaccine. The reporter stated that there were no adverse events after the first dose of Shingrix vaccine.  About 6 to 7 months after the second dose of Shingrix vaccine, the patient reported what he described as "hot spots" on his right arm and back. The hot spots were painful and they come and go, they were now on his left trunk and back. The reporter mentioned it to his doctor but his doctor did not do anything for him.  The reporter could not give a time frame of when the hot spots go away and return but he felt it might be related to the Shingrix vaccine. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: accidentally received another full course in 2023.; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a infant female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 2019 received 1st dose) and Shingrix (on 2019 received 2nd dose).   On an unknown date, the patient received the 4th dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced extra dose administered (Verbatim: accidentally received another full course in 2023.).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 15-SEP-2023 The Patient was vaccinated with a full course of Shingrix in 2019 and then accidentally received another full course in 2023.  No further information available. Caller did not give any information other than her name.   Call abandoned before any other information could be obtained. The patient accidentally received another full course, which led to extra dose administration. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a physician via call center representative 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 on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-SEP-2023 The reporter enquired that what was the efficacy with Shingrix with only a one dose immunization as the patient did not receive a second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Age indication; 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 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number DD7F7, expiry date 06-DEC-2025) for prophylaxis.   On 08-SEP-2023, the patient received Boostrix. On 08-SEP-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Age indication).  The outcome of the inappropriate age at vaccine administration 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: 15-SEP-2023 Health care professional (HCP) was unsure if Dtap was to be given and what dose pt. was on in the Dtap series.  No reactions reported. Boostrix was given to a 4 year 6 months old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up via email
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: had shingles; first dose of Shingrix in 2018 and hasn't received a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax on 2017).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: had shingles) and incomplete course of vaccination (Verbatim: first dose of Shingrix in 2018 and hasn't received a second dose).  The outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 15-SEP-2023 The pharmacist called to report a patient received a 1st dose of Shingrix in 2018 and had not received a 2nd dose.  The patient received Zostavax and in 2020 patient had shingles. Reporter stated no detail information about patient or event was available. Till the date of reporting the patient did not received 2nd dose, which lead to incomplete course of vaccination The reporter did not consent to follow-up.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness
Clinical narrative: the patient experienced dizziness; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included drug allergy (allergic to Compazine).   On 06-SEP-2023, the patient received Arexvy (intramuscular, left deltoid). In SEP-2023, 1 hr after receiving Arexvy, the patient experienced dizziness (Verbatim: the patient experienced dizziness).  The outcome of the dizziness was not resolved.   It was unknown if the reporter considered the dizziness to be related to Arexvy.     It was unknown if the company considered the dizziness to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-SEP-2023 The reporter was the spouse of the patient.  The patient was administered the vaccine at a local pharmacy.  After an hour of administering the vaccine, the patient experienced dizziness. Reporter stated that it had not resolved almost a week after.  Lot and expiration date of the vaccine were unknown. The reporter was a retired physician assistant and states that patient could not receive medication for dizziness ( Meclizine or Dramamine) because patient was allergic to Compazine.  The reporter provided consent to follow up with health care professional (HCP).
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B pediatric dose to adult patient; Engerix-B pediatric dose to adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 37-year-old female patient who received HBV (Engerix B pediatric) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis.   On 15-SEP-2023, the patient received Engerix B pediatric. On 15-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Engerix-B pediatric dose to adult patient) and adult use of a child product (Verbatim: Engerix-B pediatric dose to adult patient).  The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 15-Sept-2023 The case was reported by a nurse.  The reporter consented to follow up via email. A pediatric dose of Engerix-B was administered to an adult patient, which led to underdose and adult use of a child product.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product prescribing error
Clinical narrative: age indication; This non-serious case was reported by a other health professional via call center representative and described the occurrence of product prescribing error in an multiple number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patients received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced product prescribing error (Verbatim: age indication).  The action taken with Kinrix was unknown. The outcome of the product prescribing error 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: 15-SEP-2023 The health care professional (HCP) motioned that in the past doctors have been prescribing Kinrix in the catch up series to children under 4 whom never received the Dtap.  HCP wanted to verify if this was okay.  No adverse event details provided. The physician had prescribed Kinrix under 4 years children, which led to product prescribing error. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Gastrointestinal pain, Herpes zoster, Herpes zoster oticus, Pain in extremity, Post herpetic neuralgia
Clinical narrative: he had Ramsay- Hunt syndrome; internal shingles; internal shingles (with PHN); he had GI pain and pain from his spine to his right ring finger; right arm pain from spine to to ring finger; pain from his spine; This serious case was reported by a consumer via call center representative and described the occurrence of ramsay-hunt syndrome in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and post herpetic neuralgia.   On 17-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular). In AUG-2023, 48 hrs after receiving Shingrix, the patient experienced ramsay-hunt syndrome (Verbatim: he had Ramsay- Hunt syndrome) (serious criteria GSK medically significant), shingles (Verbatim: internal shingles), post herpetic neuralgia (Verbatim: internal shingles (with PHN)), gastrointestinal pain (Verbatim: he had GI pain and pain from his spine to his right ring finger), pain in arm (Verbatim: right arm pain from spine to to ring finger) and pain in spine (Verbatim: pain from his spine).  The patient was treated with valaciclovir (Valacyclovir). The outcome of the ramsay-hunt syndrome, shingles, post herpetic neuralgia, gastrointestinal pain, pain in arm and pain in spine were resolved.   It was unknown if the reporter considered the ramsay-hunt syndrome, shingles, post herpetic neuralgia, gastrointestinal pain, pain in arm and pain in spine to be related to Shingrix.     It was unknown if the company considered the ramsay-hunt syndrome, shingles, post herpetic neuralgia, gastrointestinal pain, pain in arm and pain in spine to be related to Shingrix.   Additional Information: GSK Receipt date: 18-SEP-2023 The patient self-reported this case. The patient stated he received Shingrix (dose 1) and within 48 hours he had GI pain and pain from his spine to his right ring finger.  He went to see HCP (healthcare professional) and was diagnosed with internal shingles (with PHN) which he had a history of.  The HCP was given Valacyclovir 2 Gm for 10 days, he then stated he had Ramsay- Hunt syndrome. He stated his symptoms had resolved now.  The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Spinal pain
Clinical narrative: he had Ramsay- Hunt syndrome; internal shingles; internal shingles (with PHN); he had GI pain and pain from his spine to his right ring finger; right arm pain from spine to to ring finger; pain from his spine; This serious case was reported by a consumer via call center representative and described the occurrence of ramsay-hunt syndrome in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and post herpetic neuralgia.   On 17-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular). In AUG-2023, 48 hrs after receiving Shingrix, the patient experienced ramsay-hunt syndrome (Verbatim: he had Ramsay- Hunt syndrome) (serious criteria GSK medically significant), shingles (Verbatim: internal shingles), post herpetic neuralgia (Verbatim: internal shingles (with PHN)), gastrointestinal pain (Verbatim: he had GI pain and pain from his spine to his right ring finger), pain in arm (Verbatim: right arm pain from spine to to ring finger) and pain in spine (Verbatim: pain from his spine).  The patient was treated with valaciclovir (Valacyclovir). The outcome of the ramsay-hunt syndrome, shingles, post herpetic neuralgia, gastrointestinal pain, pain in arm and pain in spine were resolved.   It was unknown if the reporter considered the ramsay-hunt syndrome, shingles, post herpetic neuralgia, gastrointestinal pain, pain in arm and pain in spine to be related to Shingrix.     It was unknown if the company considered the ramsay-hunt syndrome, shingles, post herpetic neuralgia, gastrointestinal pain, pain in arm and pain in spine to be related to Shingrix.   Additional Information: GSK Receipt date: 18-SEP-2023 The patient self-reported this case. The patient stated he received Shingrix (dose 1) and within 48 hours he had GI pain and pain from his spine to his right ring finger.  He went to see HCP (healthcare professional) and was diagnosed with internal shingles (with PHN) which he had a history of.  The HCP was given Valacyclovir 2 Gm for 10 days, he then stated he had Ramsay- Hunt syndrome. He stated his symptoms had resolved now.  The reporter consented to follow up.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Appetite disorder, COVID-19, Dysphagia, SARS-CoV-2 test
Clinical narrative: Little bit appetite have been different; Difficult for patient to take the drug; to swallow it whole; It came back positive still; rapid test came positive; This spontaneous case was reported by a consumer and describes the occurrence of APPETITE DISORDER (Little bit appetite have been different), DYSPHAGIA (Difficult for patient to take the drug; to swallow it whole) and COVID-19 (It came back positive still; rapid test came positive) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   On 06-Sep-2023, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced APPETITE DISORDER (Little bit appetite have been different), DYSPHAGIA (Difficult for patient to take the drug; to swallow it whole) and COVID-19 (It came back positive still; rapid test came positive). At the time of the report, APPETITE DISORDER (Little bit appetite have been different), DYSPHAGIA (Difficult for patient to take the drug; to swallow it whole) and COVID-19 (It came back positive still; rapid test came positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant medication was reported.  Reportedly, patient had 4 rounds of all, whatever shot was out there booster's, bivalent (Further suspect product was not appropriately clarified, hence captured as Unspecified Booster Shot) the whole thing but round was Moderna.  No treatment information was provided.