chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister
Clinical narrative: Blisters on his chest again on 04/08/2021 which have not resolved; This case was reported by a consumer via call center representative and described the occurrence of blister in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included oral herpes. Concomitant products included acyclovir.   On 10th February 2021, the patient received the 1st dose of Shingrix. On 8th April 2021, 57 days after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was not recovered/not resolved.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of shingrix on 10th February 2021 on his left arm and experienced blisters on chest on 18th February 2021, which was resolved on 3rd March 2021. The patient again experienced blisters on chest on 8th April 2021. The outcome of blister was not resolved yet. Till the time of reporting patient did not receive the 2nd dose of Shingrix . No further information reported. The reporter Consented to follow up This case has been linked with US2021086464, reported by same reporter for other event.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021086464:Same reporter
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Chest discomfort
Clinical narrative: Blisters on his chest again on 04/08/2021 which have not resolved; This case was reported by a consumer via call center representative and described the occurrence of blister in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included oral herpes. Concomitant products included acyclovir.   On 10th February 2021, the patient received the 1st dose of Shingrix. On 8th April 2021, 57 days after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was not recovered/not resolved.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of shingrix on 10th February 2021 on his left arm and experienced blisters on chest on 18th February 2021, which was resolved on 3rd March 2021. The patient again experienced blisters on chest on 8th April 2021. The outcome of blister was not resolved yet. Till the time of reporting patient did not receive the 2nd dose of Shingrix . No further information reported. The reporter Consented to follow up This case has been linked with US2021086464, reported by same reporter for other event.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021086464:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: a throbbing arm pain at the injection site.; throbbing arm pain at the injection site / preventing her from sleeping.; arm got pretty sore / extreme arm pain; This case was reported by a consumer via licensee and described the occurrence of injection site pain in a female 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 injection site pain, sleep problem and pain in arm. On an unknown date, the outcome of the injection site pain, sleep problem and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site pain, sleep problem and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had reacted like that with the Pfizer shot like did with Shingles shot. No further information was provided. For tolerance to the Flu shot, refer case US2021AMR087690 reported by the same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR087690:Same reporter, same patient, different suspect
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Insomnia, Pain, Pain in extremity, Sleep disorder
Clinical narrative: A throbbing arm pain at the injection site; arm got pretty sore / extreme arm pain; Throbbing arm pain at the injection site was preventing her from sleeping; This case was reported by a consumer via licensee and described the occurrence of injection site pain in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site pain, pain in arm and insomnia. On an unknown date, the outcome of the injection site pain, pain in arm and insomnia were recovered/resolved.   It was unknown if the reporter considered the injection site pain, pain in arm and insomnia to be related to Flu vaccine.  Additional details were provided as follows: The reporter was the patient herself. The age at vaccination was not reported. The patient was vaccinated with Flu shot and experienced pretty sore arm slightly. The patient also experienced throbbing arm pain at the injection site which prevented her from sleeping. The patient had also received the first dose of PFIZER-BIONTECH COVID-19 vaccine 3 to 4 days before the reporting date and experienced the same events for which she took Ibuprofen as treatment drug and applied cool packs. This case has been linked to US2021AMR087656, reported by the same reporter for Shingles vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR087656:Same reporter, same patient, different suspect
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: delayed second dose of twinrix / first dose on 11/25/2020; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 25th November 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course 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 applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. Healthcare professional was not sure if the patient would receive delayed dose on 15th April 2021. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles after getting the shingles vaccine/ Suspected vaccination failure; I got shingles after getting the shingles vaccine; This case was reported by a consumer via interactive digital 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 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 got shingles after getting the shingles vaccine. The reporter declined an offer for the current shingles vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was one of the 16 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088502:Same reporter US-GLAXOSMITHKLINE-US2021AMR088503:Same reporter US-GLAXOSMITHKLINE-US2021AMR088504:Same reporter US-GLAXOSMITHKLINE-US2021AMR088497:Same reporter US-GLAXOSMITHKLINE-US2021AMR088498:Same reporter US-GLAXOSMITHKLINE-US2021AMR088499:Same reporter US-GLAXOSMITHKLINE-US2021AMR088500:Same reporter US-GLAXOSMITHKLINE-US2021AMR088501:Same reporter US-GLAXOSMITHKLINE-US2021AMR088505:Same reporter US-GLAXOSMITHKLINE-US2021AMR088506:Same reporter US-GLAXOSMITHKLINE-US2021AMR088507:Same reporter US-GLAXOSMITHKLINE-US2021AMR088496:Same reporter US-GLAXOSMITHKLINE-US2021AMR088494:Same reporter US-GLAXOSMITHKLINE-US2021AMR088495:Same reporter US-GLAXOSMITHKLINE-US2021AMR088531:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My husband had both shots and still got 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 male 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 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 provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient had both shots and still got shingles. This case was considered as suspected vaccination failure, as information about laboratory test confirmation for shingles infection and time to event onset was unknown. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 15 people / experienced shingles; This case was reported by a consumer via interactive digital 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 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 dose of Shingles vaccine and experienced Shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was one of the 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test abnormal, Vaccination failure
Clinical narrative: suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer via interactive digital 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 age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was 1 of the 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer 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 age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was 1 of the 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 15 people got shingles after getting the shingles vaccine, suspected Vaccination failure; 15 people / experienced shingles; This case was reported by a consumer 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 age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient got shingles after getting vaccinated with the shingles vaccine. The patient declined an offer for the current shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided. This case is 1 of the 16 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 15 people / experienced shingles; This case was reported by a consumer via interactive digital 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 age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient got shingles after getting vaccinated with the shingles vaccine. The patient declined an offer for the current shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided. This case is 1 of the 16 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer via interactive digital 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 age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient got shingles after getting vaccinated with the shingles vaccine. The patient declined an offer for the current shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided. This case is 1 of the 16 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476:
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: shingles; reported it as adverse reaction. It was awful; This case was reported by a consumer and described the occurrence of shingles in a male 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 shingles and feels awful. On an unknown date, the outcome of the shingles and feels awful were recovered/resolved.   It was unknown if the reporter considered the shingles and feels awful to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient had the first vaccine and got shingles from it which was lasted several months. The PCP (primary care provider) reported it as adverse reaction and it was awful. The reporter mentioned that, she would never get this vaccine. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Second shot I felt really bad the whole weekend; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult 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 feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient got the 2nd shot and felt really bad the whole weekend. The patient had exposed twice in the past couple of months.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot for shingles and I had it three times after the shot / Suspected vaccination failure; got the shot for shingles and I had it three times after the shot; This case was reported by a consumer via  interactive digital 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 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 got the shot for shingles and he/she had shingles three times after the shot. The reporter mentioned that, the shot just stops shingles from being real bad. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Rash erythematous, Rash pruritic
Clinical narrative: rash mostly on the front part of her trunk/ which is slightly red; Itchy rash; Like hives; Pain; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of red rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in past). Previously administered products included Shingrix with an associated reaction of injection site pain (and lethargy, 2nd dose received in November 2020 in left arm, for tolerance refer case US2021088047). Concomitant products included COVID-19 VACCINE.   On 9th April 2021, the patient received the 2nd dose of Shingrix. In April 2021, less than a day after receiving Shingrix, the patient experienced red rash, itchy rash, hives, pain and fatigue. On an unknown date, the outcome of the red rash, itchy rash, hives, pain and fatigue were unknown.   It was unknown if the reporter considered the red rash, itchy rash, hives, pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received the COVID-19 vaccine, sometime after between the first and second dose of the Shingrix vaccine. Within 8 hours of vaccination, patient experienced red rash, itchy rash, hives, pain and fatigue. She started to notice rash mostly on the front part of her trunk, from her breast area to her hip area and some also wraps around to her back. She describes it as rash which was slightly red,  itchy and like hives.  She described it as rash which was slightly red, itchy and like hives. This was more on her right side of her truck than left. The patient consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021088047:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; had the shingles shot and yet I got it; so painful; This case was reported by a consumer and described the occurrence of 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), 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 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 the dose of Shingles vaccine and experienced Shingles and so painful. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received Shingrix second dose 2 weeks apart form first dose; low grade fever for 24 hrs / following the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2021, the patient received the 1st dose of Shingrix. On 1st April 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever. On 1st April 2021, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix and experienced low grade fever for 24 Hours following the dose on 12th or 14th March 2021. The patient also received the 2nd dose of Shingrix 2 weeks apart from the first dose, which led to shortening of vaccination schedule. The reporter was not at work so did not have further details.  He also mentioned that, from personal experience after administering hundreds of these things (Shingrix) the stats were pretty close to what had been reported in all the literature as far as the frequency at which the side effects happened.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR074216:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test negative, Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: antibody test done for shingles and the result was negative; received 2 doses of Shingrix vaccine 9 months apart / First dose was given in January 2020 / second dose was given in October 2020; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 2nd dose of Shingrix. In January 2020, the patient received the 1st dose of Shingrix. In October 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The case was reported by patient herself. The patient received 2 doses of Shingrix vaccine 9 months apart which led to drug dose administration interval too long. The patient had gotten antibody test done for shingles and the result was negative. The patient was referred to her healthcare provider.  The reporter disconnected the call and did not provide any further information
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: low grade fever; rash with itching on his upper abdomen that resembles chicken pox; rash with itching / Rash; rash with itching /  itching; This case was reported by a consumer and described the occurrence of chickenpox in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in his 30s).   On 12th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th March 2021 18:00, less than a day after receiving Shingrix, the patient experienced fever. In March 2021, the patient experienced chickenpox, rash and pruritus. The patient was treated with prednisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the chickenpox, rash and pruritus were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the chickenpox, rash, pruritus and fever to be related to Shingrix.  Additional details were provided as follows:  The patient received Shingrix in left deltoid. Three to seven days after receiving Shingrix, the patient noticed a rash with itching on his upper abdomen that resembled chicken pox. The patient had seen his healthcare professional and was treated with Prednisone and Benadryl.  Rash and itching had gotten progressively worse since onset.  The patient also experienced a low-grade fever at 6 pm the night of the vaccine but was gone the next morning. The reporter did not consent to follow-up.
Age: 0.5
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administrated to 6 month baby; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Medical assistance reported that ,Kinrix was administered to 6 month patient, which led to inappropriate age at vaccine administration. No adverse event was reported.  The patient's identifiers, lot number, expiration date and vaccination date was not provided. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received one Shingrix dose for sure / not sure about second dose / appointment / for a SHingrix shot on Jun 12th 2021 but thyey don´t know for what is this.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included immunodeficiency.   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 the vaccination was not applicable. The pharmacist reported for an immunocompromised patient who received Shingrix 1st dose for sure but he was not sure about the 2nd dose because he moved. The patient had appointment in a pharmacy for Shingrix shot on 12th June 2021 but did not know for what it is. There was no information available about Shingrix shot dose given for sure, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Incomplete course of vaccination, Lethargy, Vision blurred
Clinical narrative: first dose of Shingrix back in 2019 / did not receive second dose of Shingrix; difficulty walking; blurred vision; lethargy; This case was reported by a consumer via call center representative and described the occurrence of walking difficulty in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced walking difficulty, blurred vision, lethargy and incomplete course of vaccination. On an unknown date, the outcome of the walking difficulty, blurred vision and lethargy were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the walking difficulty, blurred vision and lethargy to be related to Shingrix.  Additional details were provided as follows: The reporter reported for herself. The age at the vaccination was not applicable for the 2nd dose. The patient received 1st dose f Shingrix in 2019, and experienced lethargy, blurred vision, and difficulty walking the evening of the day the first dose was received. The reporter stated that, all symptoms lasted approximately 2 days. The patient was past due for dose 2 of Shingrix and till the time of reporting, did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was administered / DOB: 02-JAN-2020; Kinrix was administered instead of Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: Kinrix was administered to the 15-month-old patient instead of Infanrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The health care profession inquired how they should proceed. The reporter did not consent to follow up.
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: first dose of Bexsero on March 4th 2021 / for the second dose Trumemba was received instead on April 4th 2021; This case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 4th March 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th April 2021, the patient received the 2nd dose of TRUMENBA. On 4th March 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: Medical assistant reported that, the patient received first dose of Bexsero vaccination on 4th March 2021 and second dose was received with Trumemba instead of Bexsero, which led to  interchange of vaccine products. No further information was provided. The vaccine administration facility is same as primary reporter. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: wife received the second Shingrix dose one month after receiving the first / dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient's husband reported the case. The age at vaccination was not reported. The patient received the second Shingrix dose one month after receiving the first Shingrix dose, which led to shortening of vaccination schedule. No other information was reported by the reporter.  The reporter was unable to obtain date of birth with initials of the patient's wife, and the route of administration as well as the lot number/expiration date of the Shingrix doses received as the patient chose to end the call before any further questions could be asked. The reporter did not consent to follow-up.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 5 year old / was administrated with Havrix adult dose; 5 year old / was administrated with Havrix adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 5-year-old female patient who received HAV (Havrix adult) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th April 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 16th April 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were 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 medical assistance reported that 5 year old patient was administrated with Havrix adult dose, which led to overdose and adult product administered to child. No adverse event was reported .  The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine was left at room temperature for / 3 hours, prior to reconstitution / clinic / administered the vaccine; This case was reported by a consumer and described the occurrence of incorrect storage of drug in a female 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 incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details was reported as follows: The case was reported by patient's daughter. The age at vaccination was not reported. The reporter was concerned about efficacy of vaccine, after clinic administered the vaccine to the patient that was left at room temperature for approximately 3 hours, prior to reconstitution, which led to incorrect storage of drug. The reporter did not consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Urticaria
Clinical narrative: possible delayed allergic reaction; hives / over his right arm (not the injection site); This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2021, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. In April 2021, less than a day after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced allergic reaction and hives. On an unknown date, the outcome of the allergic reaction and hives were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction and hives to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   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 reporter mentioned that, the patient that may have had an adverse reaction to Pediarix and would like further advice. The patient received Pediarix yesterday afternoon from the reporting date and on 16th April 2021, in morning (on the day of reporting) patient's mother sent a picture showing hives that have developed over his right arm (not the injection site). The reporter wondered if this was a possible delayed allergic reaction. The reporter consented to follow-up.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Boostrix was administrated to 1 day baby; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-day-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 16th April 2021, the patient received Boostrix. On 16th April 2021, unknown after receiving Boostrix, 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 Boostrix vaccine was administrated to 1 day old baby ,which led to inappropriate age at vaccine administration.  No adverse event was reported .  No patient's identifiers provided, no lot number nor expiration date provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late for the second dose of Shingrix / first dose was administrated on January 20 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th January 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 follow: The age at the vaccination was not applicable. The patient did not receive 2nd dose yet which lead to incomplete course of vaccination. No adverse events were reported. No lot number nor expiration date and date of birth was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix in October of 2019 / second dose in February of 2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019).   In February 2021, the patient received the 2nd dose of Shingrix. In February 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional details were provided as follow: This case was reported by consumer herself. The age at the vaccination was not reported. The patient received her 2nd dose later than the recommended interval, which lead to lengthing of vaccination schedule. The patient did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: a lot of chills; fever; she "doesn't feel good" / ended the call saying she was going to go lay down; This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever and feeling unwell. On an unknown date, the outcome of the chills, fever and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever and feeling unwell to be related to Shingrix.  Additional details were provided as follow: This case was reported by the patient for herself. The age at the vaccination was not reported. The reporter was experiencing a lot of chills and fever after receiving the Shingrix dose.  The patient also reported that she does not feel good. The patient then chose to end the call and stated that she was going to go lay down. The patient declined to provide her complete address, phone number, or email address. No further information was provided.