chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: I have shingles now and did have the two dose Shingles Vaccine/ Suspected vaccination failure; I have shingles now; Internal nerve pain; It is so very miserable; This 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve pain and feeling miserable. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, nerve pain and feeling miserable were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain and feeling miserable to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 19-June-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient reported that it was so very true about the internal nerve pain. It was so very miserable. The patient had it now. The patient had two dose shingles vaccine and had shingles. Additional supportive information: 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: Blister, Chills, Pyrexia
Clinical narrative: Blisters allover my body; Worst fever in my life; Chill and shivering; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th June 2022, the patient received the 2nd dose of Shingles vaccine. In June 2022, 3 hrs after receiving Shingles vaccine, the patient experienced blister, fever and chills. On an unknown date, the outcome of the blister, fever and chills were recovered/resolved.   It was unknown if the reporter considered the blister, fever and chills to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUN-2022 Reporter's Comments:  This case was reported by a patient via interactive digital media. The patient got second Shingles vaccine on Monday of reporting week and three hours later the patient got blisters allover his/her body. The second day the blisters gone, and the patient had the worst fever in life with chill and shivering which was recovered third day. Additional supportive information: The follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: chills; tired; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17th June 2022, the patient received the 1st dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced chills and tiredness. On an unknown date, the outcome of the chills and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the chills and tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUN-2022 Reporter's Comments: This case reported by consumer via interactive digital media. The case was reported by patient himself/herself. The patient received vaccine the day before reporting and was feeling chills and tired. Follow-up would not be possible as no contact details available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Husband got the vaccine years ago and got to shingles/Suspected vaccination failure; Husband got to shingles a month ago very painful; very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 19-JUN-2022 Reporter's Comment: This case was reported by a patient's wife via interactive digital media. The patient and his wife got the vaccine years ago from the date of reporting and he got shingles a month ago from the date of reporting which was very painful. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both vaccines did nothing for me/suspected vaccination failure; had both vaccines did nothing for me; This 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUN-2022 Reporter's Comment: The patient self-reported this case via interactive digital media and described the occurrence of suspected vaccination failure. The patient stated that he/she had both vaccines but vaccines did nothing for him/her. Additional supportive information: This case was considered as suspected vaccination failure as details regarding the 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: had both shots and had shingles twice/Suspected vaccination failure; Shingles twice; This 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 20-JUN-2022 Reporter's Comments: This case reported by consumer via interactive digital media. The patient self-reported this case. The patient had both doses and had shingles twice. Follow-up would not be possible as no contact details available. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Breast swelling, Peripheral swelling, Swelling
Clinical narrative: Hip started hurting; my arm swelled up; under my arm swelled up; my breast swelled up; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced swelling arm, swelling, breast swelling and pain in hip. On an unknown date, the outcome of the swelling arm, swelling and breast swelling were recovered/resolved and the outcome of the pain in hip was not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, swelling, breast swelling and pain in hip to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUN-2022 Reporter's Comments: This case reported by consumer via interactive digital media. The patient self-reported this case. The patient got the shot 3 weeks ago of the reporting day.  The next day her or his arm swelled up.  The next day under his or her arm and breast swelled up.  The third day all the swelling went away but his or her hip started hurting.  The patient did not know if hip was hurting from the shot or something else.  The patient asked that anyone that has taken the shot had anything like this. In 2022, the patient experienced swelling arm, swelling, breast swelling and pain in hip. For swelling and breast swelling were 2 days. For pain in hip were 3 days.. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain in extremity, Peripheral swelling
Clinical narrative: made me sick; arm was swollen under my arm; it hurt to lift it; This 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.   Previously administered products included shingles vacine with an associated reaction of illness (dose received on an unknown date, for tolerance to the 1st dose refer case US2022AMR095507). Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, swelling arm and pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness, swelling arm and pain in arm were unknown.   It was unknown if the reporter considered the sickness, swelling arm and pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR095507   Additional Information: GSK Receipt Date: 19-JUN-2022. Reporter's Comments: This case was reported by patient via interactive digital media. The patient reported that vaccine came in two series. The patient received the dose of Shingles vaccine and it made him/her sick, arm was swollen under arm and it hurt to lift it. But patient knew that he/she would not get it. Additional Supportive Information: The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR095507:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had it 4 times, Had all the shots/suspected vaccination failure; had it 4 times; This 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received all the doses of Shingles vaccine and had it fourth times. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding the 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: Erythema, Pain
Clinical narrative: redness; soreness; This case was reported by a consumer via interactive digital media and described the occurrence of erythema 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, unknown after receiving Shingles vaccine, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were unknown.   It was unknown if the reporter considered the erythema and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-JUN-2022 Reporter's Comments: This case was received from patient's cousin via interactive digital media. The reporter wants to know that how long should the redness and soreness last after the first shot. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: 1st dose yesterday arm is real sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th June 2022, the patient received the 1st dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-Jun-2022. Reporter's comments: The patient self-reported the case via interactive digital media. The patient got Shingles vaccine in an unknown arm and his/her arm was real sore. Additional supportive information: Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Scab, Vaccination failure
Clinical narrative: got shingles, had the Shingles vaccine; few scabs on face; got shingles on right eyebrow and forehead; This 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 8th April 2022, less than 2 years after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and scab. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the scab was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and scab to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-JUN-2022 Reporter's comment: This case was received from patient interactive digital media. The patient got shingles on his/her right eyebrow and forehead. Because it was close to patient's eye primary made him/her go and got his/her eye checked and it was ok. The patient had the Shingles vaccine 2 years ago but still got it. The patient was assume it probably would of been worse. He/she still had a few scabs on face but nearing the end.  The patient know if you get it in your ears you could lose your hearing. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation were not provided.    The follow-up would not possible as no contact details were available
Sex: M
Vaccine: VARZOS
Symptoms: Arthropathy, Blood cholesterol, Blood test, Glycosylated haemoglobin, Laboratory test
Clinical narrative: 1st shot left my arm a little sore; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included blood pressure high (The reporter mentioned blood pressure under control). Concomitant products included lisinopril.   On 4th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR096161   Additional Information: GSK receipt date: 20-June-2022 Reporter's comment: The patient received 1st covid 19 vaccination on the 25th February 2021 and 2nd dose on 18th March 2021 on right arm. The shingles 1st dose were given on 4th January 2021 and 2nd dose on 28th June 2021 on the left arm. The patient reporterd that after 1st shingles shot left arm little sore and second was without pain. By the end of june patient's hand was terrible and refer to neurologist in looking Parkinson symtoms. Blood test and urine test were done for looking kidney function,A-1C, cholesterol level, vitamin deficiency, thyroid problem. The patient reported all blood test were excellent and no abnormalities. The patient had 2check up with Lisinopril for high blood pressure which was control under 3 year. On 3rd visit physician prescribed carbidopa-levodopa since 9th march 2022 and stop taking on 6th June 2022. For 2nd dose refer case US2022AMR096161.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR096161:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging, Pain in extremity, Renal function test, Urine analysis
Clinical narrative: 1st shot left my arm a little sore; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included blood pressure high (The reporter mentioned blood pressure under control). Concomitant products included lisinopril.   On 4th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR096161   Additional Information: GSK receipt date: 20-June-2022 Reporter's comment: The patient received 1st covid 19 vaccination on the 25th February 2021 and 2nd dose on 18th March 2021 on right arm. The shingles 1st dose were given on 4th January 2021 and 2nd dose on 28th June 2021 on the left arm. The patient reporterd that after 1st shingles shot left arm little sore and second was without pain. By the end of june patient's hand was terrible and refer to neurologist in looking Parkinson symtoms. Blood test and urine test were done for looking kidney function,A-1C, cholesterol level, vitamin deficiency, thyroid problem. The patient reported all blood test were excellent and no abnormalities. The patient had 2check up with Lisinopril for high blood pressure which was control under 3 year. On 3rd visit physician prescribed carbidopa-levodopa since 9th march 2022 and stop taking on 6th June 2022. For 2nd dose refer case US2022AMR096161.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR096161:Same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shots and got it./ Suspected vaccination failure; had the shots and got it; This 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 20-Jun-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had the shots and got it. It was not bad and no blister or rash. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only got liquid part of vaccine; Only got liquid part of vaccine; This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a 11-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 20th May 2022, the patient received Menveo. On 20th May 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-Jun-2022. Reporter's Comments: Nurse reported that the patient received only the liquid component of Menveo. The reporter noticed 1 powder left in the box at the end. The reporter consented to follow up.  Additional Supportive Information: The patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case was linked with US2022088510 and US2022AMR095691 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022088510:Same reporter US-GLAXOSMITHKLINE-US2022AMR095691:Same reporter
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only got liquid part of vaccine; Only got liquid part of vaccine; This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 25th May 2022, the patient received Menveo. On 25th May 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-JUN-2022 Reporter's comment: It was reported that patient may only got liquid part of vaccine. The reporter noted 1 powder vial left over in box. On 15th June 2022, the patient came back to office and received a full dose of Menveo. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of only the liquid vial of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.This case was linked with case US2022088510, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022088510:Same reporter US-GLAXOSMITHKLINE-US2022AMR095683:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Coronavirus infection, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; covid; This 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.   The patient's past medical history included shingles (had shingles for years).   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and coronavirus infection. On an unknown date, the outcome of the vaccination failure, shingles and coronavirus infection were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and coronavirus infection to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-JUN-2022 Reporter's Comments: This case was reported by patient via  interactive digital media and described the occurrence of suspected vaccination failure. In 2019, the patient received shots of Shingles vaccine. After receiving Shingles vaccine, the patient had Covid in 2020 and  then shingles came back. The patient asked if she could take a shot again. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the completion of primary immunization and laboratory confirmation of shingles were unknown. Follow up would not be possible as contact details were not available. The age of patient was reported as 65 year's however it was age at time of reporting not event onset, hence no age was captured in field.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Had all the vaccines, still got the shingles/Suspected vaccination failure; Still got the shingles; 4 months later the itching was worse than at the beginning; Pain was very little; Patient had stretched like a dog with fleas for 4 months.; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, itching, pain and feeling abnormal. On an unknown date, the outcome of the vaccination failure, shingles, itching and pain were unknown and the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, itching, pain and feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-JUN-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient had all the vaccines, still got the shingles, and 4 months later the itching was worse than at the beginning.  The patient was fortunate as far as pain, had very little but had stretched like a dog with fleas for 4 months. Additional Supportive Information: 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
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the vaccine and still got shingles/suspected vaccination failure; Still got shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-Jun-2022. Reporter's Comments: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. The patient had the vaccine and still got the shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for herpes zoster were unknown. The follow up would not be possible as contact details were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Blood cholesterol, Blood test, Glycosylated haemoglobin, Hypovitaminosis, Magnetic resonance imaging normal
Clinical narrative: Right hand began to tremble; This case was reported by a consumer via other manufacturer and described the occurrence of tremor of hands in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included BIONTECH COVID-19-VACCINE with an associated reaction of pain in extremity (1st dose received on 25th February 2021, through intramuscular route on right arm with batch number EN6201), BIONTECH COVID-19-VACCINE (2nd dose received on 18th March 2021, through intramuscular route on right arm with batch number EN6208) and Shingrix with an associated reaction of pain in extremity (received 1st dose on 4th January 2021, refer case US2022AMR095656). Concurrent medical conditions included blood pressure high (since August 2019). Concomitant products included lisinopril.   On 28th June 2021, the patient received the 2nd dose of Shingrix. In June 2021, less than a week after receiving Shingrix, the patient experienced tremor of hands. The patient was treated with carbidopa + levodopa (Carbidopa-Levodopa). On an unknown date, the outcome of the tremor of hands was not recovered/not resolved.   It was unknown if the reporter considered the tremor of hands to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR095656   Additional Information: GSK receipt date: 20-June-2022 Reporter's comment: The patient had 2check up with Lisinopril for high blood pressure which was control under 3 year. The patient received 2nd dose of shingles vaccine on the left arm. The patient reported that after 1st shingles shot left arm little sore and second was without pain. By the end of June patient's hand was terrible and refer to neurologist in looking Parkinson symptoms. Blood test and urine test were done for looking kidney function,A-1C, cholesterol level, vitamin deficiency, thyroid problem. The patient reported all blood test were excellent and no abnormalities. The patient had 2 check ups and prescribed with carbidopa Levodopa since 9th March 2022, and patient had stopped taking it since 6th June 2022 to see if there was change on hand tremor.  Additional supportive information:  This case has been linked with case US2022AMR095656 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR095656:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Renal function test, Thyroid disorder, Tremor, Urine analysis
Clinical narrative: Right hand began to tremble; This case was reported by a consumer via other manufacturer and described the occurrence of tremor of hands in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included BIONTECH COVID-19-VACCINE with an associated reaction of pain in extremity (1st dose received on 25th February 2021, through intramuscular route on right arm with batch number EN6201), BIONTECH COVID-19-VACCINE (2nd dose received on 18th March 2021, through intramuscular route on right arm with batch number EN6208) and Shingrix with an associated reaction of pain in extremity (received 1st dose on 4th January 2021, refer case US2022AMR095656). Concurrent medical conditions included blood pressure high (since August 2019). Concomitant products included lisinopril.   On 28th June 2021, the patient received the 2nd dose of Shingrix. In June 2021, less than a week after receiving Shingrix, the patient experienced tremor of hands. The patient was treated with carbidopa + levodopa (Carbidopa-Levodopa). On an unknown date, the outcome of the tremor of hands was not recovered/not resolved.   It was unknown if the reporter considered the tremor of hands to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR095656   Additional Information: GSK receipt date: 20-June-2022 Reporter's comment: The patient had 2check up with Lisinopril for high blood pressure which was control under 3 year. The patient received 2nd dose of shingles vaccine on the left arm. The patient reported that after 1st shingles shot left arm little sore and second was without pain. By the end of June patient's hand was terrible and refer to neurologist in looking Parkinson symptoms. Blood test and urine test were done for looking kidney function,A-1C, cholesterol level, vitamin deficiency, thyroid problem. The patient reported all blood test were excellent and no abnormalities. The patient had 2 check ups and prescribed with carbidopa Levodopa since 9th March 2022, and patient had stopped taking it since 6th June 2022 to see if there was change on hand tremor.  Additional supportive information:  This case has been linked with case US2022AMR095656 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR095656:Same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shots and still had light case of shingles/ suspected Vaccination failure; Had shots and still had light case of shingles; This 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.   In November 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. In May 2022, between 5 and 7 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The patient self-reported the case via interactive  digital media and described the occurrence of suspected vaccination failure. The patient received last shot of Shingles vaccine in first week of November 2021. After receiving Shingles vaccines, the patient still had light case of shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting. The follow up would not be possible as no contact details were available
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: both Shingles vaccinations but got shingles/suspected vaccination failure; Shingles; This 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Jun-2022 Reporter's comments: This case was reported by patient via interactive digital media and described occurrence of suspected vaccination failure. The patient got 2 doses of Shingrix and still experienced shingles and wanted to know if could receive booster dose. Additional Supportive Information:  This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation were unknown at the time of reporting.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received liquid component of menveo; received liquid component of menveo; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA643A, expiry date 30th November 2022) for prophylaxis.   On 15th June 2022, the patient received Menveo. On 15th June 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-June-2022 Reporter's Comments: The patient received only the liquid component of the menveo vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received only the liquid component of the Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Incorrect product administration duration, Pain in jaw, Vaccine positive rechallenge
Clinical narrative: first dose October 2021, second on 13-JUN-2022; Headache; Jaw pain; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose in October 2021 and experienced headache, refer case US2022AMR094558).   On 13th June 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 13th June 2022, unknown after receiving Shingrix, the patient experienced drug administration duration too long. In June 2022, the patient experienced headache, jaw pain and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, jaw pain and fatigue were recovered/resolved and the outcome of the drug administration duration too long was unknown.   It was unknown if the reporter considered the headache, jaw pain and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The reporter was the patient's wife.  The patient received Shingrix in arm and experienced headache, jaw pain and fatigue.  The reporter stated that the effects were resolved. The reporter had nothing else to report. The patient was not available to give consent for follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. This case has been linked to US2022094109, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022094109:Same reporter US-GLAXOSMITHKLINE-US2022AMR094558:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Neuralgia, Pain, Pyrexia
Clinical narrative: Fever; Chills; Aches and pain; Nerve issues in her right leg/nerve pain similar to shingles 15 years ago; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced 15 years ago prior to the reporting).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 hrs after receiving Shingrix, the patient experienced fever, chills, pain and nerve pain. On an unknown date, the outcome of the fever, chills and pain were recovered/resolved and the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, pain and nerve pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: The patient received Shingrix 5 months from time of reporting, and 5 hours after her first dose, she experienced fever, chills, aches and pain which lasted for several days. The patient also reported that a few weeks after her dose, she developed nerve issues in her right leg which was still ongoing, and this nerve pain was similar to the nerve pain she had when she had shingles 15 years prior to the reporting. The reporter did not consent ed to follow-up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix was expired and administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 18th June 2022) for prophylaxis.   On 20th June 2022, the patient received Havrix. On 20th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comment: Nurse reported that Havrix was expired on 18th June 2022 and was administered on 20th June 2022 to the patient. The HCP (Health Care Professional) did not have permission to provide further details of patient or vaccine. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Havrix vaccine which was already expired, which led to expired vaccine used.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose was administered on 12-DEC-2018 and the 2nd dose 12-JAN-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received first dose of Shingrix on 12th December 2018).   On 12th January 2022, the patient received the 2nd dose of Shingrix. On 12th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK Receipt Date: 21-Jun-2022 Reporters comment: The patient wanted to receive a third dose of Shingrix as the second dose was administered late. The reporter confirmed that no third dose was administered. The reporter wanted to know if any information available. The reporter consented to follow up. Additional Supportive Information: The patient received two doses of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th June 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 21-Jun-2022 Reporter's Comments: The reporter stated that a patient accidently received an expired Havrix vaccine. The patient received a dose on 20th June 2022 when the expiration date of the vaccine was on 18th June 2022 The reporter did not consent to follow-up. Additional Supportive Information: The patient received Havrix which was already expired in 18th June 2022, which led to expired vaccine used.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered on 10Jun2022, expiration date 04Jun2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received HBV (Engerix B) (batch number 239TF, expiry date 4th June 2022) for prophylaxis.   On 10th June 2022, the patient received the 2nd dose of Engerix B. On 10th June 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-Jun-2022 Reporter's Comments: The reporter stated that a patient was administered a dose of Engerix-B on 10th June 2022, with an expiration date of 04th June 2022. This was the patient's second dose in the series. At the time of reporting, repeat dose had not been administered. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The reporter need to know the vaccine safety and efficacy data for a Hepatitis B vaccine that administered after the expiration date. Additional Supportive Information: The patient received Engerix B expired vaccine, which led to expired vaccine used.