chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: Called pt to verify symptoms - received dose on 3/17, sx's started at 1 a.m. on 3/18 and lasted until Sunday evening.  She had fever, intense chills, vomiting, fatigue, and severe "internal" pain from head to toe.  Injection site was bruised, no rash.  Sx's had totally resolved by Monday.   Patient reported event on 3/23/23.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: the patient is not experiencing any symptoms at this time; PROQUAD was administered with VARIVAX inadvertently, instead of pure MMR-II; Inappropriate schedule of product administration; PROQUAD was administered with VARIVAX inadvertently, instead of pure MMR-II; This spontaneous report has been received from Other Health Professional and refers to an 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-MAR-2023, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (strength, lot number, expiration date, and route of administration were not provided); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (strength, lot number, expiration date, and route of administration were not provided) (inappropriate schedule of product administration and accidental overdose), instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (wrong product administered ). The patient did not experienced any symptoms at the moment of the report. No additional adverse event reported.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; LVN reporting a dose of MMRII with a labeled expiry of 3/1/2023 was inadvertently administered to a patient on 3/3/2023.; This spontaneous report was received from licensed practical nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-MAR-2023, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml, lot #U006596, expiration date: 01-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse events reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE on VARIVAX; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.  On 24-FEB-2023, the patient  was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U019908, expiration date: 24-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided).  The vaccine was stored in a temperature of 7.2F/(6°F up to 14°F) for 1 hour 22 minutes. There was a previous temperature excursion of 10.9F/(6°F up to 14°F) for 1 hour 18 minutes 36 seconds. No additional adverse event/No PQC.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to state that the patient was given PROQUAD after a TE event.; no additional AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product storage error). No adverse event was reported.; Sender's Comments:  US-009507513-2303USA006990: US-009507513-2303USA007002: US-009507513-2303USA006967:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to state that the patient was given PROQUAD after a TE event.; no additional AE/PQC.; his spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product storage error). No adverse event was reported.; Sender's Comments:  US-009507513-2303USA006990:MSD US-009507513-2303USA007002:MSD US-009507513-2303USA006967:MSD
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to state that the patient was given VARIVAX after a TE event.; no additional AE/PQC.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product storage error). No adverse event was reported. ; Sender's Comments:  US-009507513-2303USA006990: US-009507513-2303USA007002: US-009507513-2303USA006967:
Sex: F
Vaccine: HPV9
Symptoms: Guillain-Barre syndrome, Mechanical ventilation, Paralysis
Clinical narrative: Physician states that a patient's mother (who was a nurse) reported that she had worked with a physician whose daughter ended up on a ventilator with paralysis after receiving GARDASIL-9; The patient ended up on a ventilator with paralysis; The patient ended up on a ventilator with paralysis; This spontaneous information has been received from a physician regarding a female patient of unknown age. Patient's pertinent medical history, drug reactions and allergies and concomitant medication were unknown by reporter.  On an unknown date, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), injection, administered for prophylaxis, (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided).  On an unknown date in approximately 2019 (also reported as sometime "within the past 3 years but not within the past 6 months), the patient ended up on a ventilator (mechanical ventilation) with paralysis after receiving the suspect vaccine and it was suspected that the patient may have been Guillain-Barré syndrome (guillain-Barre syndrome). The reporter assessed the event with a hospitalization criteria. The outcome of the events was not provided.  The causal relationship regarding the suspect vaccine and the events was not provided.  Upon internal review the events mechanical ventilation, paralysis, and Guillain-Barré syndrome were considered as medically significant.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose: 03-DEC-2013, second dose: 20-JAN-2016; This spontaneous report has been received from a health care professional via immunization record from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS #2302USA008539), concerning a 12-year-old male patient.  The patient was vaccinated with the first, and second dose of Hepatitis A Vaccine, Inactivated (manufacturer unknown) on 03-DEC-2013 and 20-JAN-2016 (inappropriate schedule of product administration), respectively; as prophylaxis (formulations, strengths, doses, anatomical locations, routes of administration, lot numbers and expiration dates were not reported).; Sender's Comments:  US-009507513-2302USA008539:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; HCP calling to report T.E for MMR II vaccine. T.E case filed 02358855. MMR II vaccine was administered to the patient and a AE case was filed. Permission given to contact the physician. No additional AE/PQC reported.; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 23-MAR-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 1 dose, administered for prophylaxis, lot number reported as U205199 but upon internal review established as invalid, expiration date reported as 13-AUG-2023 (strength and route of administration were not provided) after a temperature excursion (product storage error). No additional adverse event reported.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: varivax administered on  17-JUL-2000 then on 27-MAY-2010; This spontaneous report has been received from a health care professional via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS# 2110USA001194) concerning 10 years-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JUL-2000, the patient was vaccinated with dose# 1 of varicella virus vaccine live (oka/merck) (VARIVAX) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   On 27-MAY-2010 the patient received the second dose of  varicella virus vaccine live (oka/merck) (VARIVAX) (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of vaccine administered).  This is one from 4 cases from the same patient.; Sender's Comments:  US-009507513-2110USA001194: US-009507513-2303USA008561: US-009507513-2303USA008558: US-009507513-2110USA001194:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My shot is what gave them to me/Suspected Vaccination Failure; gave them to me; 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: My shot is what gave them to me/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: gave them to me). 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: 13-MAR-2023 The case was received from the patient interactive digital media. The patient stated that his/her Shingles shot what gave them (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: Has the shots, has shingles now/Suspected vaccination failure; Shingles outbreak; 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: Has the shots, has shingles now/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles outbreak). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   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: 13-MAR-2023 The case was received from the patient's friend interactive digital media. The patient had Shingles shots and now had severe outbreak of 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: Have had shots, still 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 a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Have had shots, still 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: 13-MAR-2023 The case was received from the patient interactive digital media. The patient had Shingles shots 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: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Had 3 shots and still got them/; Shingles; Had 3 shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had 3 shots and still got them/) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and extra dose administered (Verbatim: Had 3 shots). The outcome of the vaccination failure and extra dose administered were 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, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that his wife received 3 doses of Shingles vaccine and still experienced Shingles. The patient received extra dose of Shingles vaccine in error, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Stress, Tension, Vaccination failure
Clinical narrative: I got my shots too but still got them/suspected vaccination failure; Still got them; Tension; Stress; 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 my shots too but still got them/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Still got them), tension (Verbatim: Tension) and stress (Verbatim: Stress). The outcome of the vaccination failure was unknown and the outcome of the shingles, tension and stress were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, tension and stress to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, tension and stress to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient got the shots too but still got them. The patient stated that they were caused by tension and stress. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shingles shot, got 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shingles shot, got 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: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient got the shingles shot and got shingles for the second time. The patient stated from hospital in. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Got the double dose vaccine, had symptoms twice, dealing with it now/Suspected vaccination failure; Had symptoms twice, dealing with it now (shingles); It might be post herpetic neuralgia; No rash, just pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the double dose vaccine, had symptoms twice, dealing with it now/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had symptoms twice, dealing with it now (shingles)), post herpetic neuralgia (Verbatim: It might be post herpetic neuralgia) and pain (Verbatim: No rash, just pain). The outcome of the vaccination failure was unknown and the outcome of the shingles, post herpetic neuralgia and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and pain to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the double dose of shingles vaccine.  The patient had symptoms twice since and the patient was dealing with it now. The reporter further stated that it might be post-herpetic neuralgia.  The reporter further stated that there was no rash, just pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after each dose /Suspected vaccination failure; Got shingles after each dose (1st dose); Got shingles after each dose (2nd dose); This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles after each dose /Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles after each dose (1st dose)) and shingles (Verbatim: Got shingles after each dose (2nd dose)). Rechallenge with Shingles vaccine was positive. The outcome of the vaccination failure was unknown and the outcome of the shingles and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the 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 and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The patient had both shingles shots and got shingles after each shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Formication, Herpes zoster, Pain, Skin discomfort, Vaccination failure
Clinical narrative: Had shot, had shingles/suspected vaccination failure; ShinglesTwice; skin has something crawling underneath; Pain is the worst; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shot, had shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: ShinglesTwice), skin discomfort (Verbatim: skin has something crawling underneath) and pain (Verbatim: Pain is the worst). The outcome of the vaccination failure was unknown and the outcome of the shingles, skin discomfort and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, skin discomfort and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, skin discomfort and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that it was like his/her skin had something crawling underneath and the pain was the worst but had the shingles shot and only had the shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in Dec2021, okay to give 2nd dose now?; This non-serious case was reported by a other health professional 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 (Received 1st dose on December 2021).   On an unknown date, the patient did not receivedthe 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in Dec2021, okay to give 2nd dose now?). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13 Mar 2023 It was reported that the patient received one dose of Shingrix in December 2021 and if it was okay to give the second dose nowor if the vaccination series have to be restarted. The patient did not received 2nd dose till the time of reporting which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: Feeling nauseous; Arm was very tender; feeling very achy; Muscles started to hurt; felt very weak; Vomited up; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced nausea (Verbatim: Feeling nauseous), pain in arm (Verbatim: Arm was very tender), pain (Verbatim: feeling very achy), muscle pain (Verbatim: Muscles started to hurt), weakness (Verbatim: felt very weak) and vomiting (Verbatim: Vomited up). The outcome of the nausea, pain in arm, pain, muscle pain, weakness and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the nausea, pain in arm, pain, muscle pain, weakness and vomiting to be related to Shingrix.     It was unknown if the company considered the nausea, pain in arm, pain, muscle pain, weakness and vomiting to be related to Shingrix.   Additional Information: GSK Receipt date: 13-Mar-2023 The second day after patient got the Shingrix shot he/she started feeling nauseous and his/her arm was very tender. Later on, the same day when he/she was at work he/she started feeling very achy. The patient's muscles started to hurt, and he/she felt very weak. The next day he/she tried to eat breakfast and vomited up all of his/her food. The patient feeling all of these symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Tenderness, Vomiting
Clinical narrative: Feeling nauseous; Arm was very tender; feeling very achy; Muscles started to hurt; felt very weak; Vomited up; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced nausea (Verbatim: Feeling nauseous), pain in arm (Verbatim: Arm was very tender), pain (Verbatim: feeling very achy), muscle pain (Verbatim: Muscles started to hurt), weakness (Verbatim: felt very weak) and vomiting (Verbatim: Vomited up). The outcome of the nausea, pain in arm, pain, muscle pain, weakness and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the nausea, pain in arm, pain, muscle pain, weakness and vomiting to be related to Shingrix.     It was unknown if the company considered the nausea, pain in arm, pain, muscle pain, weakness and vomiting to be related to Shingrix.   Additional Information: GSK Receipt date: 13-Mar-2023 The second day after patient got the Shingrix shot he/she started feeling nauseous and his/her arm was very tender. Later on, the same day when he/she was at work he/she started feeling very achy. The patient's muscles started to hurt, and he/she felt very weak. The next day he/she tried to eat breakfast and vomited up all of his/her food. The patient feeling all of these symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Burning pain in my body; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain burning in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain burning (Verbatim: Burning pain in my body). The outcome of the pain burning was not recovered/not resolved.   It was unknown if the reporter considered the pain burning to be related to Shingles vaccine.     It was unknown if the company considered the pain burning to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that they administered the shot and the burning pain in his/her body started. The patient was fine before they injected him/her 5 days ago, let's see when they go away. The follow-up could not be possible as no contact details were available. As per reported information it seems that the patient still experiencing burning pain and wait for it's recovering, therefore conservatively outcome was captured as not recovered.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: The shot made me very 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.   In JAN-2023, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: The shot made me very 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: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient got the first shingles shot in January and will get his/her second one in April and the shot made him/her very sick. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Illness, Pain
Clinical narrative: Soreness; shivering/chills; felt like crap for a day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (1st dose received on an unknown date and it was good, no problem).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Soreness), shivering (Verbatim: shivering/chills) and sickness (Verbatim: felt like crap for a day). The outcome of the pain and shivering were not reported and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the pain, shivering and sickness to be related to Shingles vaccine.     It was unknown if the company considered the pain, shivering and sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-MAR-2023 The case was received from the patient interactive digital media. The patient stated that the second Shingles shot knocked him/her for a loop. The patient had soreness, chills and shivering, felt like crap for a day or so but, so glad as he/she got the jab.  The patient stated that now he/she did not had to worry about the real deal. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Relieve pain but not completely; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic drug effect in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included blister (From the sternum breast bone, across the right breasts, under the arm, around the back to the spine, and down the right arm to the fingertips and the worst area was the armpit). Concurrent medical conditions included pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unexpected therapeutic drug effect (Verbatim: Relieve pain but not completely). The outcome of the unexpected therapeutic drug effect was unknown.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The patient had big weepy blisters that hurt and itched at the same time the physician stated that it was not unusual for a patient to blister up twice, but when he/she had blistered up the third time the physician stated that he had never seen that happen. The patient blistered up fourth time then the physician stated that some was gonna have to rewrite all the medical books because that had never been reported. The patient reported that he/she still have some pain in that area. The patient received Shingles vaccine and it had helped him/her to relieve the pain a little but not completely. The patient reported that hopefully he/she will not get the blisters again, he/she trusting in to protect him/her from another flare up. Follow-up would not possible as no contact details were available. The patient stated that the shingles vaccine helped him/her to relieve pain, which led to unexpected therapeutic drug effect.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Very 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: Very 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: 13-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received shingles vaccine and experienced Sick. The physician stated that was normal and not as bad as the real virus and your description sounds a lot worse. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox twice). Previously administered products included Shingles vacine (1st dose received on an unknown date).   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 sickness (Verbatim: Sick). The outcome of the sickness was not reported.   The reporter considered the sickness to be possibly related to Shingles vaccine.     The company considered the sickness to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received both doses of Shingles vaccine. The patient experienced sick from the second dose. The patient stated that it was better than suffering from shingles. The patient have had chickenpox twice, so he/she convinced that he/she did the right prevention. Follow-up would not possible as no contact details were available. According to narrative verbatim the causality was conservatively captured as possible
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I got one shot and never got the second one; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I got one shot and never got the second one). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 13-Mar-2023 Years ago, the Shingles vaccine was using a live culture.  The patient was advised not to get it because of his/her immune problems.  Now it was not a live culture.  The patient got one shot and never got the second one.  The patient wonder if he/she could get it years later or have to take both again. He/she did not know what it would hurt.  The physician advised him/her not to take it when they used a live culture because of his/her immune problems.  Later when they did not, got one of them and never got the second one.  It had been years, but reporters wonder if he/she could just get the second one now or do he/she had to get both again. 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: Hypoaesthesia, Pruritus, Skin irritation
Clinical narrative: numbness; itching; felt like Sandpaper rubbing on my stomach.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of numbness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles over a year ago).   On 14-DEC-2022, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced numbness (Verbatim: numbness), pruritus (Verbatim: itching) and skin irritation (Verbatim: felt like Sandpaper rubbing on my stomach.). The outcome of the numbness was not recovered/not resolved and the outcome of the pruritus and skin irritation were not reported.   It was unknown if the reporter considered the numbness, pruritus and skin irritation to be related to Shingles vaccine.     It was unknown if the company considered the numbness, pruritus and skin irritation to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient got the first shingles shot and had numbness on his/her stomach from it. The patient stated that you could put an ice cube in the numb area, and he/she could not even felt it. The patient stated that plus his/her back was itching about all the time and when his/her shirt rubbed across his/her stomach, it felt like sandpaper rubbing on his/her stomach. The patient stated that numbness on his/her stomach was still there. The patient will be getting his/her second shingles shot in June 2023. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: First one didn't work, shingles; Very painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: First one didn't work, shingles) and pain (Verbatim: Very painful). The outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient have had shingles twice and also had two shots. The first one did not work and then the second more stronger seems to be working. But it was the patient could always get them back and hopefully not. The patient stated that it was very painful. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: MMR
Symptoms: Intercepted product storage error
Clinical narrative: None were reconstituted or administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of intercepted product storage error in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient did not receive Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced intercepted product storage error (Verbatim: None were reconstituted or administered). The outcome of the intercepted product storage 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.  GSK Receipt Date: 13-MAR-2023 Reporter's Comments:  The reporter was a GlaxoSmithKline representative stating a temperature excursion was reported to him. He stated a nurse manager reported that the Priorix vaccines were stored in the freezer (for hours) and would like to know if they were viable. None of the vaccines were reconstituted or administered. Medical information phone number provided. Consented to follow up.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Condition aggravated, Hepatic enzyme increased
Clinical narrative: Liver enzymes elevated after 2nd dose; Liver enzymes elevated after 2nd dose; received 2nd dose on 12/14/2022; This non-serious case was reported by a consumer via call center representative and described the occurrence of elevated liver enzymes in a 65-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   The patient's past medical history included elevated liver enzymes (history of unexplained, elevated liver enzymes). Concomitant products included HEPATITIS B VACCINE (ENGERIX B ADULT).   On 14-DEC-2022, the patient received the 2nd dose of Engerix B adult. On 14-DEC-2022, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: received 2nd dose on 12/14/2022). On an unknown date, the patient experienced elevated liver enzymes (Verbatim: Liver enzymes elevated after 2nd dose) and condition aggravated (Verbatim: Liver enzymes elevated after 2nd dose). The outcome of the elevated liver enzymes was not recovered/not resolved and the outcome of the condition aggravated was not reported and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the elevated liver enzymes and condition aggravated to be related to Engerix B adult.     It was unknown if the company considered the elevated liver enzymes and condition aggravated to be related to Engerix B adult.   Additional Information: GSK Receipt date: 13-Mar-2023 and 14-Mar-2023 The reporter was the patient. The patient had history of unexplained, elevated liver enzymes, but noticed they were even more elevated after receiving first and second dose of Engerix B.  The patient had liver function test prior to receiving first dose of Engerix B showed an AST level of 25 and ALT level of 29.  The patient reported AST level was 54 and ALT level was 140 when liver function test completed after first and second dose of Engerix B. The reporter consented to follow up.