chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: forty three children were administered varicella virus vaccine from a shipment that was stored out of the refrigerator for 5 days; This spontaneous report has been received from unspecified reporter via company representative concerning a children of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. The reporter stated that the patient was vaccinated from a shipment that was stored out of the refrigerator for 5 days.   This is one of 45 case reported by the same reporter..
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: forty three children were administered varicella virus vaccine from a shipment that was stored out of the refrigerator for 5 days; This spontaneous report has been received from unspecified reporter via company representative concerning a children of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. The reporter stated that the patient was vaccinated from a shipment that was stored out of the refrigerator for 5 days.  This is one of 45 case reported by the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: forty three children were administered varicella virus vaccine from a shipment that was stored out of the refrigerator for 5 days; This spontaneous report has been received from unspecified reporter via company representative concerning a children of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. The reporter stated that the patient was vaccinated from a shipment that was stored out of the refrigerator for 5 days.   This is one of 45 cases reported by the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: forty three children were administered varicella virus vaccine from a shipment that was stored out of the refrigerator for 5 day; This spontaneous report has been received from unspecified reporter via company representative concerning a children of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. The reporter stated that the patient was vaccinated from a shipment that was stored out of the refrigerator for 5 days.   This is one of 45 cases reported by the same reporter.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Medical Assistant reported that PROQUAD and V ARlV AX was Inadvertent Concomitant Administrated to a one year old patient; No additional adverse events reported; This spontaneous report has been received from a medical assistant concerning to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route of administration, strength, lot # and date expiration were not provided) for prophylaxis and inadvertent on the same date with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, strength, lot # and date expiration were not provided).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Seizure, Syncope, Vomiting
Clinical narrative: Seizure; Syncope; Diarrhoea; Chills; Vomiting; This case VAERS (Reference number: 0989940) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE (Seizure) and SYNCOPE (Syncope) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epilepsy. Concurrent medical conditions included Drug allergy (sulfa). Concomitant products included LAMOTRIGINE, PHENYTOIN SODIUM (DILANTIN D.A.) and LEVONORGESTREL (MIRENA) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, SEIZURE (Seizure), SYNCOPE (Syncope), DIARRHOEA (Diarrhoea), CHILLS (Chills) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient experienced profuse vomiting and diarrhea, syncope, chills, seizures. Emergency room visit received 3 bags of lactated ringers, 12 mg of IV zofran, 12.5 mg of IV Phenergan. Full blood work and 2 computerized tomogram (CT) scans but results were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events of chills, vomiting, and diarrhea, a causal relationship cannot be excluded. Causality for the events of seizure and syncope are probably related to the patient's medical history.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of chills, vomiting, and diarrhea, a causal relationship cannot be excluded. Causality for the events of seizure and syncope are probably related to the patient's medical history.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myoclonic epilepsy, Pyrexia
Clinical narrative: myoclonic seizure; Dizziness; fever; This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCLONIC EPILEPSY (myoclonic seizure), DIZZINESS (Dizziness) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Migraine headache.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MYOCLONIC EPILEPSY (myoclonic seizure) (seriousness criteria hospitalization and medically significant), DIZZINESS (Dizziness) (seriousness criterion hospitalization) and PYREXIA (fever) (seriousness criterion hospitalization). The patient was hospitalized on 21-Mar-2021 due to DIZZINESS, MYOCLONIC EPILEPSY and PYREXIA. At the time of the report, MYOCLONIC EPILEPSY (myoclonic seizure), DIZZINESS (Dizziness) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported. Concomitant medications were not reported.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Bone swelling, Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: fever of 101; developed swelling left side neck and below ear; swollen jaw and ear on left side (possible lymph nodes); golf ball sized lump on clavicle same side (L) as injection; swollen jaw and ear on left side (possible lymph nodes); swollen jaw and ear on left side (possible lymph nodes); pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date, refer case US2021104543).   On 14th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). In May 2021, 24 hrs after receiving Shingrix, the patient experienced pain, fever, neck swelling, ear swelling, bone swelling, jaw swelling and enlargement of lymph nodes. Rechallenge with Shingrix was positive. In May 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain, neck swelling, ear swelling, bone swelling, jaw swelling and enlargement of lymph nodes were not recovered/not resolved.   It was unknown if the reporter considered the pain, fever, neck swelling, ear swelling, bone swelling, jaw swelling and enlargement of lymph nodes to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The patient received second dose of Shingrix in Left arm.  On 15th May 2021, the patient developed swelling on left side of neck and below ear, golf ball sized lump on clavicle on left side, swollen jaw and ear on left side (possible lymph nodes), pain and fever of 101 degree farenheit.  No lot number or expiry date was available.  The patient was recommended follow up with her healthcare professional and was offered Shingrix package insert. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021104543:same patient (1st dose)
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Vaccine positive rechallenge
Clinical narrative: fever of 101; developed swelling left side neck and below ear; swollen jaw and ear on left side (possible lymph nodes); golf ball sized lump on clavicle same side (L) as injection; swollen jaw and ear on left side (possible lymph nodes); swollen jaw and ear on left side (possible lymph nodes); pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date, refer case US2021104543).   On 14th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). In May 2021, 24 hrs after receiving Shingrix, the patient experienced pain, fever, neck swelling, ear swelling, bone swelling, jaw swelling and enlargement of lymph nodes. Rechallenge with Shingrix was positive. In May 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain, neck swelling, ear swelling, bone swelling, jaw swelling and enlargement of lymph nodes were not recovered/not resolved.   It was unknown if the reporter considered the pain, fever, neck swelling, ear swelling, bone swelling, jaw swelling and enlargement of lymph nodes to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The patient received second dose of Shingrix in Left arm.  On 15th May 2021, the patient developed swelling on left side of neck and below ear, golf ball sized lump on clavicle on left side, swollen jaw and ear on left side (possible lymph nodes), pain and fever of 101 degree farenheit.  No lot number or expiry date was available.  The patient was recommended follow up with her healthcare professional and was offered Shingrix package insert. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021104543:same patient (1st dose)
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: rash under my arms(It is extremely itchy); Possible shingles; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced itchy rash and shingles. The patient was treated with hydrocortisone (Cortisone Topical Cream). On an unknown date, the outcome of the itchy rash was not recovered/not resolved and the outcome of the shingles was unknown.   It was unknown if the reporter considered the itchy rash and shingles to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced Itchy rash under the arm. The dermatologist thinks that patient had developed shingles after the first dose. The patient was treated with cortisone and other creams which weren't effective. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Feeling abnormal, Herpes zoster, Neuralgia, Pain
Clinical narrative: It's the worst pain I have ever felt; My nerve endings feel like they are on fire; It is awful; Got the two part shingles vaccine in early 2020. On Feb 26, 2021 I broke out in shingles anyway / Suspected vaccination failure; Got the two part shingles vaccine / On Feb 26, 2021 I broke out in shingles anyway; The rash took a month to go away; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On 26th February 2021, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain, rash, burning sensation and feels awful. On an unknown date, the outcome of the vaccination failure, shingles, pain and feels awful were unknown and the outcome of the rash was recovered/resolved and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, rash, burning sensation and feels awful to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received two part of Shingles vaccine in early 2020 and on 26th February 2021, he/she broke out in shingles anyway, right shoulder and neck area. The reporter mentioned that, it was the worst pain he/she have ever felt and rash took a month to go away. The reporter mentioned that, it was 12 weeks now and though the rash was gone, his/her nerve endings feel like they were on fire and it was awful. The patient had been on different prescription medications and had barely any relief. The reporter mentioned that, he/she woke up every morning and hope it was gone, maybe tomorrow, he/she pray. 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: Rash, Vaccination failure
Clinical narrative: It's the worst pain I have ever felt; My nerve endings feel like they are on fire; It is awful; Got the two part shingles vaccine in early 2020. On Feb 26, 2021 I broke out in shingles anyway / Suspected vaccination failure; Got the two part shingles vaccine / On Feb 26, 2021 I broke out in shingles anyway; The rash took a month to go away; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On 26th February 2021, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain, rash, burning sensation and feels awful. On an unknown date, the outcome of the vaccination failure, shingles, pain and feels awful were unknown and the outcome of the rash was recovered/resolved and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, rash, burning sensation and feels awful to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received two part of Shingles vaccine in early 2020 and on 26th February 2021, he/she broke out in shingles anyway, right shoulder and neck area. The reporter mentioned that, it was the worst pain he/she have ever felt and rash took a month to go away. The reporter mentioned that, it was 12 weeks now and though the rash was gone, his/her nerve endings feel like they were on fire and it was awful. The patient had been on different prescription medications and had barely any relief. The reporter mentioned that, he/she woke up every morning and hope it was gone, maybe tomorrow, he/she pray. 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
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and then got them 3 years later / Suspected vaccination failure; had the shot and then got them 3 years later not a mild case either; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years 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 patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had the shot and then got shingles 3 years later and mentioned that not a mild case either. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Incomplete course of vaccination, Rash pruritic
Clinical narrative: still suffering itchy, Burning rash!!! ever since; Burning rash!!! ever since; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced itchy rash and burning sensation. On an unknown date, the outcome of the itchy rash and burning sensation were unknown.   It was unknown if the reporter considered the itchy rash and burning sensation to be related to Shingrix.  Additional details provided were as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received the first dose of Shingrix 2 years ago experienced Itchy rash and burning. The patient refused the booster dose. The pharmacist sent the report which was never heard back from manufacturer.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got two shingle shots and still got the shingles / Suspected vaccination failure; I got two shingle shots and still got the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 Shingles vaccine and 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 details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 2 doses of Shingles vaccine and still got the shingles. 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. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: The only people I know who have had shingles, got it after having the shot! / Suspected vaccination failure; The only people I know who have had shingles, got it after having the shot!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 reported as follows: The age at vaccination was not applicable for this report. The reporter stated he/she know people who had shingles, got it after having the Shingles shot. 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. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2021, the patient received the 2nd dose of Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced chills and headache. On an unknown date, the outcome of the chills and headache were unknown.   It was unknown if the reporter considered the chills and headache to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication. The patient received Shingrix vaccine and experienced chills and a headache. The patient wanted to if this was something to be concerned about or should it dissipate fairly soon.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shot and I got shingles but a mild case / Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure 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 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 reported as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Shingles vaccine and got shingles but a mild case. The patient stated that shots did not prevent shingles, it might cause it to be a milder case. The patient stated that she wished they would stop making it sound false, like if you get the shot you would not get shingles.  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. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR106775, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR106775:same reporter (husband case)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles after we had the vaccine, suspected vaccination failure; got shingles after we had the vaccine; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 case was reported by the patient for himself/herself. The age at vaccination was not reported.  The age group was not reported but was captured as an adult as per vaccine indication. The patient experienced shingles after receiving the Shingles vaccine. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset were unknown. This case has been linked with US2021AMR106649, reported by same reporter for patient's brother.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR106649:Same reporter. Brother´s case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had been vaccinated & still had shingles not as bad/ Suspected Vaccination failure; Had been vaccinated & still had shingles not as bad; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 case was reported by the patient. The age at vaccination was not reported. The age group was not reported but selected as an adult as per the vaccine indication. The patient had been vaccinated and still had shingles not as bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles after we had the vaccine/Suspect vaccination failure; got shingles after we had the vaccine.; This case was reported by a consumer via media and described the occurrence of suspected 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) 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 patient received Shingles vaccine and got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown. This case has been linked with US2021AMR106617, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR106617:Same reporter .
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and so far she has gotten the shingles two times since/ Suspected Vaccination failure; got the shot and so far she has gotten the shingles two times since; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure 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 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 reporter was patient's parent. The age at vaccination was not reported. The reporter commented not to bother to get the shot, as the patient got the shot and got shingles 2 times till the reporting date. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My husband had the shot and he got shingles/ Suspect vaccination failure; My husband had the shot and he got shingles; This case was reported by a consumer via media and described the occurrence of suspected 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) 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 case was reported by the wife of the patient. The age at vaccination was not reported. The reporter stated that her husband had the shingles shot and he got shingles. The reporter stated that the shot does not always stop from getting shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shot / then got a second batch of shingles just not as bad/Suspected vaccination failure; got a second batch of shingles just not as bad; This case was reported by a consumer via media and described the occurrence of suspected 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) 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 reported as follows: The age at vaccination was not reported. The patient received Shingles vaccine year later and then got a second batch of shingles just not as bad. The patient stated that he wished they would stop making it sound false, like if you get the shot you would not get shingles.  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. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR106601, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: must have needed a booster shot / I have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult 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 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: This case was reported by patient itself. The age group was not reported but was captured as adult as per vaccine indication. The age at vaccination was not reported. The patient received Shingles vaccine and experienced shingles. The patient guessed if he/she must had needed a booster shot. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the vaccine...I still get them/Suspect vaccination failure; I had the vaccine...I still get them....; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient had the Shingles vaccine ahd still get the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Tinnitus
Clinical narrative: New onset of tinnitus; This case was reported by a consumer and described the occurrence of tinnitus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID 19 VACCINE PFIZER for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were reported as follow: This case was reported by consumer. The age at vaccination was not reported. The patient experienced new onset of tinnitus after dose 1 of Shingrix and after dose 2 of Pfizer Covid-19 vaccine.  It was unknown if which product it was related to tinnitus.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: got shingles on right back; still have major post herpetic pain; major aching in that spot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) (batch number UNK, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles, post herpetic neuralgia and pain. On an unknown date, the outcome of the shingles, post herpetic neuralgia and pain were unknown.   It was unknown if the reporter considered the shingles, post herpetic neuralgia and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported,however captured as adult as per vaccine indication The patient got Shingrix shot in January, 2 days later got shingles on right back. At the time of reporting the patient still had have major post herpetic pain, no blisters, but major aching in that spot.  The patient asked if he/she should get the second shot. No contact details were provided
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine / wanted to be administered with second dose / 1st dose was administered during 2018; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrx (in March 2018, received 1st dose).   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. Pharmacy intern reported that the patient was overdue for dose two of Shinrgix series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Consent to follow up was given.  The healthcare professional did not provide lot number or expiration date of dose one. No additional information was provided. VAERS details were reported for 1st dose.   Follow up information was provided by pharmacist on 19th May 2021: The reporter stated that, a 55 years old patient wanted to be administered with 2nd dose of shingrix but the 1st dose was administered during 2018. The reporter was asking for data about Shingrix Schedule and how to operate in such scenario. The Healthcare professional did not administer the second dose of shingrix and the 2nd line agent provided him with the information about new schedule for Shingrix.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: administration / of the first adult dose / to a pediatric patient; administration / of the first adult dose / to a pediatric patient; This case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 19-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   On 12th May 2021, the patient received the 1st dose of Engerix B adult. On 12th May 2021, unknown after receiving Engerix B adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were reported as follows: The age at vaccination was not reported however it could be 19 years. The pediatric patient received adult dose of Engerix B adult on 12th May 2021 which led to adult product administered to child and overdose. No events were reported. The reporter did not asked for consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Myalgia, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: redness at injection site; General myalgia; low grade fever; left arm is swollen; Skin was hot to the touch on the left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2021, the patient received the 1st dose of Shingrix (intramuscular). On 10th May 2021, 8 hrs after receiving Shingrix, the patient experienced injection site erythema, myalgia, low grade fever, swelling arm and feeling hot. On an unknown date, the outcome of the injection site erythema, myalgia, swelling arm and feeling hot were not recovered/not resolved and the outcome of the low grade fever was recovered/resolved.   The reporter considered the injection site erythema, myalgia, swelling arm and feeling hot to be related to Shingrix. It was unknown if the reporter considered the low grade fever to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. 8 hours after receiving 1st dose of Shingrix, the patient experienced general myalgia, redness at the injection site on her left arm, skin was hot to the touch on the left arm and the left arm was swollen and low grade fever which resolved after couple of days. The reporter stated that, she was was still experiencing these side effects. The Patient will contact her HCP if the symptoms did not resolve. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Inappropriate schedule of product administration, Incomplete course of vaccination, Injection site pain
Clinical narrative: got his first Shingrix shot on 20 OCT 2020 and has not gotten his second shot yet; had COVID-19 disease; injected (left) arm was sore after his first Shingrix dose; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On 20th October 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain. On 11th January 2021, the patient experienced covid-19. On an unknown date, the patient experienced incomplete course of vaccination. On 22nd October 2020, the outcome of the injection site pain was recovered/resolved. On 16th February 2021, the outcome of the covid-19 was recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain and covid-19 to be related to Shingrix. It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 1st dose on left arm  through intramuscular route on  20th October 2020 batch number and expiry date was not reported and experienced pain at injection site. The patient had covid 19 disease on 11th January 2021 and recovered on 16th February 2021due to which patient did not received the second dose which led to the incomplete course of vaccination. The reporter did not consent to follow up.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: administered / expired dose of Hiberix/ expiration date: 04/18/2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received Hib (Hiberix) (batch number 4A99Z, expiry date 18th April 2021) for prophylaxis.   On 18th May 2021, the patient received the 1st dose of Hiberix. On 18th May 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The nurse reported that the patient received vaccine of Hiberix which was already expired on 18th April 2021. No further events were reported at the time of the call. The health care professional declined follow up and it was obtained from the internet.