chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported.; the vaccine was administered Intramuscular (IM) instead of Subcutaneous (SC); This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender.      The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 23-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # T018893 with expiration date of 02-JUN-2022, at dose of 0.5 (unit not provided), intramuscularly instead of subcutaneously (incorrect route of product administration), for prophylaxis. No additional AE reported.
Age: 44.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional adverse effects; administered expired GARDASIL 9 and if it is supported; This spontaneous report was received from a certified medical assistant refers to a 44-year-old male patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication.   On 23-SEP-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe, dose:0.5 milliliter,  lot # 1602283, expiration date: 16-AUG-2021(expired product administered), for prophylaxis (dose number, and  route of administration, were not reported). The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  did not experience any temperature excursion.   No further information provided. No additional adverse effects and no PQC. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602283; expirationdate: 16-AUG-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: much worse left leg pain; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2021AMR198904).   On 16th September 2021, the patient received the 2nd dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced leg pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the leg pain was unknown.   It was unknown if the reporter considered the leg pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient had Shingrix vaccine on day before reporting and had much worse leg pain and asked was this one of the side effects. The follow-up was not possible as contact information was not available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198904:Same patient, 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Chronic disease, Fear
Clinical narrative: permanent lifetime diseases, triggered by a vaccine; This case was reported by a consumer via media and described the occurrence of chronic disease in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chronic disease. On an unknown date, the outcome of the chronic disease was not recovered/not resolved.   The reporter considered the chronic disease to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was living with permanent lifetime diseases that were triggered by a vaccine. The patient stated that it would have been better to have taken the chances without getting it. The patient stated that was right down scary what was happening. The patient wished that he/ she had been informed of potential side effects. The patient also stated to help us all.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was sister-in-law of the reporter. The age at vaccination was not reported. The patient went to the doctors and got the shingles shot and the next day, she got the shingles. The patient asked her doctor about why she got the shingles because shingles was the reason that she went and got the vaccine shot and the doctor communicated that there was a little bit of Shingles in the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Arm was sore; Arm was red; 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.   In August 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got the dose about a month ago and arm was sore and red for about 5 to 6 days.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Why do I have a rash; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient was asking why do he/she have a rash after first dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Immediate post-injection reaction
Clinical narrative: shingles, got them worse than ever; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had shingles twice and they hurt like heck).   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had shingles twice and they hurt like heck. Then the patient got the vaccine and almost immediately got the shingles again worse than ever which the physician said it should not be happen. The follow up was not required.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got Shingrix and had outbreak/ Suspected vaccination failure; outbreaks continued; This case was reported by a pharmacist via sales rep and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (about 3 outbreaks per year).   In August 2017, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. In August 2017, the patient received 1st dose of Shingrix and 2 months later received the 2nd dose. This patient has had about 3 outbreaks of shingles per year which continued which have continued after having 2 Shingrix shots. The reporter asked if a third dose (or booster dose) could be given. The reporter consented to follow up. The case has been linked with the case US2021AMR200646 (1st dose), reported by same same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR200646:Same patient, first dose
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: almost cost her her eyesight!; This case was reported by a consumer and described the occurrence of visual impairment in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced visual impairment. On an unknown date, the outcome of the visual impairment was unknown.   It was unknown if the reporter considered the visual impairment to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's daughter. The age at vaccination was not reported. The reporter ask to check the side effects. The patient got the shingle shot and still got shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles on head, face and neck; This case was reported by a consumer via (Shingrix ) interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN).   In April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported The patient had the Shingrix vaccine in early April.  45 days after second COVID shot, the patient reacted to the vaccine and got shingles in 3 places on head face and neck.  The reporter asked what should he/she do regarding the second dose. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise, Pain in extremity
Clinical narrative: arm still hurts; feel really crappppy; This case was reported by a consumer media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and feeling abnormal. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the pain in arm and feeling abnormal to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported The patient had received the first dosage on last Thursday from the day of reporting and my arm still hurts, also felt really crappy. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Vaccination failure
Clinical narrative: had the latest vaccination, had shingles/ suspected Vaccination failure; filled prescription for shingles at all times; pain; nerve damage; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Since 2015 more than 10 times).   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, pain and nerve damage. On an unknown date, the outcome of the vaccination failure, shingles, pain and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and nerve damage to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles Since 2015 more than 10 times. The patient stated he/she had the latest Shingles vaccination and it has kept the pain from been so intense. The patient stated he/she keep a filled prescription for shingles at all times. The patient stated he/she had nerve damage from having shingles. The patient stated he/she did not wish these on anyone. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Inappropriate schedule of product administration, Injection site erythema, Injection site pain, Limb discomfort
Clinical narrative: redness at injection site; with stress on left arm; first and second dose received 3 or 4 weeks apart. Caller; experiencing pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In May 2021, the patient received the 2nd dose of Shingrix. In May 2021, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, arm discomfort and drug dose administration interval too short. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema was recovering/resolving and the outcome of the arm discomfort and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and arm discomfort to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient reported that receiving both the 1st and 2nd dose of Shingrix in the left arm in May of 2021, the reporter was uncertain of exact dates, but stated they only received 1st and 2nd dose 3 or 4 weeks apart which led to shortening of vaccination schedule. The patient experiencing pain and redness at injection site immediately after receiving 2nd dose of Shingrix. The event redness had lessened but was still visible.  The pain was moderate, consistent, and ongoing.  The pain worsens with stress on left arm or if he sleeps on the left arm. The reporter consented to follow up. For tolerance in 1st dose refer case US2021200827.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021200827:Same case US-GLAXOSMITHKLINE-US2021200827:Same patient,2nd dose
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Sleep disorder
Clinical narrative: redness at injection site; with stress on left arm; first and second dose received 3 or 4 weeks apart. Caller; experiencing pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In May 2021, the patient received the 2nd dose of Shingrix. In May 2021, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, arm discomfort and drug dose administration interval too short. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema was recovering/resolving and the outcome of the arm discomfort and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and arm discomfort to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient reported that receiving both the 1st and 2nd dose of Shingrix in the left arm in May of 2021, the reporter was uncertain of exact dates, but stated they only received 1st and 2nd dose 3 or 4 weeks apart which led to shortening of vaccination schedule. The patient experiencing pain and redness at injection site immediately after receiving 2nd dose of Shingrix. The event redness had lessened but was still visible.  The pain was moderate, consistent, and ongoing.  The pain worsens with stress on left arm or if he sleeps on the left arm. The reporter consented to follow up. For tolerance in 1st dose refer case US2021200827.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021200827:Same case US-GLAXOSMITHKLINE-US2021200827:Same patient,2nd dose
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: redness at injection site; with stress on left arm; first and second dose received 3 or 4 weeks apart. Caller; experiencing pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In May 2021, the patient received the 2nd dose of Shingrix. In May 2021, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, arm discomfort and drug dose administration interval too short. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema was recovering/resolving and the outcome of the arm discomfort and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and arm discomfort to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient reported that receiving both the 1st and 2nd dose of Shingrix in the left arm in May of 2021, the reporter was uncertain of exact dates, but stated they only received 1st and 2nd dose 3 or 4 weeks apart which led to shortening of vaccination schedule. The patient experiencing pain and redness at injection site immediately after receiving 2nd dose of Shingrix. The event redness had lessened but was still visible.  The pain was moderate, consistent, and ongoing.  The pain worsens with stress on left arm or if he sleeps on the left arm. The reporter consented to follow up. For tolerance in 1st dose refer case US2021200827.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021200827:Same case US-GLAXOSMITHKLINE-US2021200827:Same patient,2nd dose
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Inappropriate schedule of product administration, Injection site erythema, Injection site pain, Limb discomfort
Clinical narrative: experiencing pain immediately after receiving 1st dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2021, the patient received the 1st dose of Shingrix. In May 2021, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The patient received a dose of Shingrix vaccine and immediately experienced pain. The patient reported that pain resolved approximately one week after receiving first dose. The reporter consented to follow-up with health care professional. The case is linked with case US2021AMR201079, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201079:Same patient,2nd dose
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Sleep disorder
Clinical narrative: experiencing pain immediately after receiving 1st dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2021, the patient received the 1st dose of Shingrix. In May 2021, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The patient received a dose of Shingrix vaccine and immediately experienced pain. The patient reported that pain resolved approximately one week after receiving first dose. The reporter consented to follow-up with health care professional. The case is linked with case US2021AMR201079, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201079:Same patient,2nd dose
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: experiencing pain immediately after receiving 1st dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2021, the patient received the 1st dose of Shingrix. In May 2021, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The patient received a dose of Shingrix vaccine and immediately experienced pain. The patient reported that pain resolved approximately one week after receiving first dose. The reporter consented to follow-up with health care professional. The case is linked with case US2021AMR201079, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201079:Same patient,2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot, had shingles/ Suspected vaccination failure; Had shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine and had shingles. The reporter stated the Shingles shot did not prevent from getting shingles. But it could lessen the severity of the disease. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shots, shingles / suspected vaccination failure; shingles; This case was reported by a consumer via 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, between 4 and 5 months after receiving Shingles vaccine and between 6 and 7 months 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the shots this past spring. The patient came down with shingles a week and a half ago. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got a shot supposedly for shingles, three years later I still have them / suspected vaccination failure; still have them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got a shot supposedly for shingles. Three years later patient still had them and all the time, they never did go away. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shot gave a permanent case of shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 details were provided as follows: The age at vaccination was not reported. The reporter stated Shingles shot gave a patient permanent case of the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Shingrix vaccine at 40; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 40-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, received dose of Shingrix, at the age of 40 years old, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm hurts; arm is swollen; 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 an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were unknown.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingle shot and her/his arm hurts and swollen, but still better than getting shingles. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Rotarix was inadvertently administered IM; This case was reported by a other health professional via media and described the occurrence of inappropriate route of vaccination in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination 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 details were provided as follows: The age at vaccination was not reported. The patient was inadvertently administered with Rotarix intramuscularly, which led to inappropriate route of vaccination. The reporter wanted to know need to know what to do. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received 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 case details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The reporter stated that his or her friend got a shingles vaccine and had a very painful attack that lasted a month. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case has been linked with US2021AMR201252, reported by same reporter. Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR201252: tag at post.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine and had shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the vaccine and had shingles twice since then. The patient thought severity was lessened, but not prevented. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: took the shot, had them again / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's brother had shingles in late 2015), pruritus (Family History) (patient's brother had itching in late 2015) and shingles.   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 case details were reported as follows: The reporter was patient's brother. The age at vaccination was not reported. The patient took the shot. He had shingles again. The reporter stated that it was not as bad but still got them. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: unable to get the second shot within 6 months; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked Should now get the second shot or should start with the first again.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: It's been a year since first shot; This case was reported by a consumer via (Shingrix  interactive digital media 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 a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. 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: Incomplete course of vaccination
Clinical narrative: never got second one; This case was reported by a other health professional via (Shingrix  interactive digital media 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 in June 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked, should the patient restart over.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Illness, Pain in extremity
Clinical narrative: sick; headaches; chills; pain in the arms; This case was reported by a consumer via (Shingrix   interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received Shingrix. On 23rd September 2021, less than a day after receiving Shingrix, the patient experienced sickness, headache, chills and pain in arm. On an unknown date, the outcome of the sickness, headache, chills and pain in arm were unknown.   It was unknown if the reporter considered the sickness, headache, chills and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingle shot and felt sick, headaches, chills, pain in the arms. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced rash. The reporter was looking to see how he/she could report a rash reaction to Shingrix vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Facial filler reaction/ facial fillers swell; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt a facial filler reaction as facial fillers swelling. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not get his second; This case was reported by a other health professional via (Shingrix interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if the patient needed to repeat the entire cycle or could just have the second.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st doseon 23rd October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked, what should the patient needed to do.
Age: 48.0
Sex: M
Vaccine: FLU4, HEP, TDAP
Symptoms: Product storage error
Clinical narrative: exposure to freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 48-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number KN5VR, expiry date 16th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 24BM2, expiry date 30th June 2022) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   On 16th September 2021, the patient received Boostrix, Boostrix Pre-Filled Syringe Device, FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Boostrix, Boostrix Pre-Filled Syringe Device, FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device and Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 case details were reported as follows: The reporter called due to their discovery that, the patient was inadvertently administered on 16th September 2021 the vaccines that were in the temperature excursion, which led to incorrect storage of drug. This patient was administered both the Flulaval and Boostrix vaccine on the same day. The agent informed pharmacist the vaccines should be discarded due to exposure to freezing temperatures 31.5 Fahrenheit for 13 hours. The reporter did not consent to follow up. This is 1 of 7 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021198149:same reporter US-GLAXOSMITHKLINE-US2021198148:same reporter US-GLAXOSMITHKLINE-US2021198144:same reporter US-GLAXOSMITHKLINE-US2021198142:same reporter US-GLAXOSMITHKLINE-US2021198139:same reporter