chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: develop shingles after completing two dose of Shingrix/Suspected vaccination failure; shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a elderly 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, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient was in her 70's. The age at vaccination was not reported. The patient developed shingles after completing two doses of Shingrix. This case was considered as suspected vaccination failure as details regarding the time to onset for target disease and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in an adult 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 muscle pain, tiredness, and pain. The patient was treated with paracetamol (TYLENOL). On an unknown date, the outcome of the muscle pain, tiredness and pain were unknown. It was unknown if the reporter considered the muscle pain, tiredness, and pain to be related to SHINGRIX. Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but captured adult as per vaccine indication. The patient received vaccine and experienced muscle pain, tiredness, and pain. The patient received T for pain and asked how to mitigate the muscle pain and ease the tiredness. No other information was available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: I have the shingles now and I got the shot years l ago; I didn't know there was a 2 shot; 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) (batch number UNK, expiry date unknown) 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 not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for 2nd dose. The age group was not reported, however captured as adult as per vaccine indication. The patient received 1 dose of shingle vaccine years ago and experienced shingle. The patient did not know about two shot of shingle and received only one shot. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: burning during injection; This case was reported by a consumer via other manufacturer and described the occurrence of injection site burning in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) (batch number UNK, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, immediately after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site burning. On an unknown date, the outcome of the injection site burning was unknown.   It was unknown if the reporter considered the injection site burning to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported to had burning during injection of flu shot.; Sender's Comments:  US-MYLAN-AE-2021-7214:ID
Sex: U
Vaccine: VARZOS
Symptoms: Depressed mood, Feeding disorder, Neuropathy peripheral, Weight decreased
Clinical narrative: I developed neuropathy under my breasts and stomach; Have lost 20 pounds because I can't hardly eat; I can't hardly eat because of the neuropathy; I am very unhappy / will join a class action lawsuit; This case was reported by a consumer and described the occurrence of neuropathy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant), weight loss, unable to eat and depressed mood. The patient was treated with gabapentin. On an unknown date, the outcome of the neuropathy, weight loss, unable to eat and depressed mood were unknown.   The reporter considered the neuropathy, weight loss, unable to eat and depressed mood to be possibly related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself via email. 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 wanted to protect itself from shingles, so received Shringrix vaccine 5 months ago and developed neuropathy under his/her breasts and stomach, had lost 20 pounds because he/she could not hardly eat because of the neuropathy. The patient spoke to his/her doctor and he said it was very likely that he/she received it from the vaccine, and He had prescribed Gabapentin. The patient was very unhappy and would join a class action lawsuit. The patient stated his/her life had changed forever, and none of his/her family members have had neuropathy and he/she fair warned them about this shot.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had it in the same place after I got the shot; 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 reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  After getting the shot, the patient had shingles in the same place. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got the shot and had a reaction / shingles in the worse place; 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 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 the 1st dose of Shingles vaccine and had a reaction as shingles in the worse place. The patient stated he/she did not know if he/she would have 2nd dose. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I get shingles which I never had, every few months; Painful but not dehabiliting; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   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 reporter was the patient. 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 regretted for getting the Shingles vaccine because the patient got shingles which they never had. The patient got those shingles every few months, it was painful but not dehabilitating.  The patient wished that they never had gotten the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: extreme chills; headache; very achy; This case was reported by a consumer via (Shingrix GSK and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 26th April 2021, the patient received the 1st dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced chills, headache and ache. On an unknown date, the outcome of the chills, headache and ache were unknown.   It was unknown if the reporter considered the chills, headache and ache to be related to Shingrix.  Additional details were provided as follows: The reporter had reported for herself. The age at vaccination was not reported. The patient received Covid 19 vaccine, 10 weeks back from the date of reporting. After receiving Shingrix, the patient had extreme chils, headache and she was very achy to the point of not been to be able to. The followup would not possible as no contact details were available. This case had been linked with case US2021AMR094527, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094527:Same reporter, husband case
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: extreme chills; headache; very achy; This case was reported by a consumer via (GSK Chatbot) interactive digital media and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   In April 2021, the patient received the 1st dose of Shingrix. In April 2021, less than 2 weeks after receiving Shingrix, the patient experienced chills, headache and pain. On an unknown date, the outcome of the chills, headache and pain were unknown.   It was unknown if the reporter considered the chills, headache and pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient's wife. The age at vaccination was not reported. 10 weeks from reporting date, the patient received COVID vaccinations. The patient received dose of Shingrix last week and had some side effects, extreme chills, headache, very achy to the point of not being to be able to. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR094508, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094508:Same reporter, spouse case
Sex: U
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent).    On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced allergic reaction (serious criteria hospitalization). On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The patient had severe allergic reaction and needed to stay in hospital after receiving GSK FluLaval Quadrivalent vaccine. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot as soon:as it was available. I still got a light case of it/Suspected vaccination failure; Got the shot as soon:as it was available. I still got a light case of it; 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.   The patient's past medical history included chickenpox (had at age of almost 3 years old). Concurrent medical conditions included allergic skin reaction.   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 of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles after vaccination. The patient had skin allergies hence he or she got shot as soon as it was avilable. The patient got light case of shingles in the fall of 2017. The patient's brother born with Chickenpox. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I did and I still have shingles/Suspected vaccination failure; I did and I still have 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.   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. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles after vaccination. The patient said that vaccine did not work for everyone. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: had 3 shots and I still get them just not as bad/suspected Vaccination failure; had 3 shots and I still get them just not as bad; had 3 shots; 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 and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient was the reporter itself. 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 3 doses of Shingles vaccine and experienced shingles. The patient received 3rd dose of Shingles vaccine, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My wife got the shot then got the shingles / Suspected vaccination failure; My wife got the shot then got the 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 provided as follows: The patient was reporter's wife. The age at vaccination was not reported. The reporter mentioned that, the patient got the shot then she got the shingles no lie. 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. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: suspected Vaccination failure; I have had the 2 shots required 2 to 3 months apart and still get them; They are miserable; Lasting nerve pain can last for quite awhile; 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 an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling miserable and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles, feeling miserable and nerve pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, feeling miserable and nerve pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient was the reporter itself. 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 2 doses of Shingles vaccine and experienced shingles, nerve damage and felt miserable. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Scar, Skin discolouration
Clinical narrative: suspected vaccination failure; received two doses / between 2019-2020 /In 2021 /experienced an episode of Shingles; blisters had gone away but marks are still there; marks cose; This case was reported by a nurse via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior to the 1st dose of Shingrix in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and skin discoloration. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles and skin discoloration were unknown and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and skin discoloration to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient received 1st and 2nd dose of Shingrix between 2019 to 2020 (unspecified). In 2021, the patient experienced an episode of Shingles. Till the time of reporting, the blisters had gone away but marks were still there. This patient received local and topical Acyclovir for the treatment of this shingles episode. This case was considered as suspected vaccination failure as details regarding, event onset time and laboratory confirmation for shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination failure; received two doses / between 2019-2020 /In 2021 /experienced an episode of Shingles; blisters had gone away but marks are still there; marks cose; This case was reported by a nurse via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior to the 1st dose of Shingrix in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and skin discoloration. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles and skin discoloration were unknown and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and skin discoloration to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient received 1st and 2nd dose of Shingrix between 2019 to 2020 (unspecified). In 2021, the patient experienced an episode of Shingles. Till the time of reporting, the blisters had gone away but marks were still there. This patient received local and topical Acyclovir for the treatment of this shingles episode. This case was considered as suspected vaccination failure as details regarding, event onset time and laboratory confirmation for shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Mast cell activation syndrome
Clinical narrative: similar cases encountered in other patients, mechanism of activation of mast cells after the administration of adjuvant.; This case was reported by a physician and described the occurrence of mast cell activation syndrome in an unspecified number of patients 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 mast cell activation syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the mast cell activation syndrome was unknown.   It was unknown if the reporter considered the mast cell activation syndrome to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not applicable for this report.  The reporter wanted information about adjuvant metabolism, as cases were encountered in patients for activation of mast cells after the administration of adjuvant. This case has been linked with US2019184363, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019184363:same reporter
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered an expired 20mcg/ml booster dose of Engerix -B; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number 3G535, expiry date 24th January 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was inadvertently administered an expired dose of Engerix B 20mcg/ml as booster dose, which led to expired vaccine administered. The reporter would like to know the efficacy of vaccine after expiration. The reporter did not consent to follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Incomplete course of vaccination, Injection site pain, Injection site pruritus
Clinical narrative: sharp pain in her left shoulder; sharp pain in her back; first dose of shingrix in August of 2020; had itching / at the injection site; also had / warmth at the injection site; also had pain/at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In August 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site itching, injection site warmth and injection site pain. On an unknown date, the patient experienced shoulder pain, back pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site itching, injection site warmth and injection site pain were not recovered/not resolved and the outcome of the shoulder pain and back pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site itching, injection site warmth, injection site pain, shoulder pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination was not applicable for 2nd dose of Shingrix. In August 2020, The patient received 1st dose of Shingrix in left arm. The patient experienced sharp pain in left shoulder and back which resolved without intervention in few days. The patient also had itching, pain and warmth at the injection site which had not resolved since getting the injection. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient stated that, there was no rash present. No other information obtained. The reporter did not consent to follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: sharp pain in her left shoulder; sharp pain in her back; first dose of shingrix in August of 2020; had itching / at the injection site; also had / warmth at the injection site; also had pain/at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In August 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site itching, injection site warmth and injection site pain. On an unknown date, the patient experienced shoulder pain, back pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site itching, injection site warmth and injection site pain were not recovered/not resolved and the outcome of the shoulder pain and back pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site itching, injection site warmth, injection site pain, shoulder pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination was not applicable for 2nd dose of Shingrix. In August 2020, The patient received 1st dose of Shingrix in left arm. The patient experienced sharp pain in left shoulder and back which resolved without intervention in few days. The patient also had itching, pain and warmth at the injection site which had not resolved since getting the injection. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient stated that, there was no rash present. No other information obtained. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix on February 2019 / 2nd dose has not been received yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Since the HCP (Health Care Professional) was driving and could not provide details. No patient identifiers, expiration date or lot number was provided. The reporter consented to follow up
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1 dose of kinrix administered to a 8 years old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included pediarix (has all other Pediarix doses as needed) and infanrix (has all other Infanrix doses as needed).   On 23rd October 2020, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd October 2020, 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 1st dose of Kinrix was administered to the 8 years old patient, which led to inappropriate age at vaccine administration. The reporter stated that, the patient had all other pediarix and infanrix (dtap and IPV series) as needed (no details were provided) and was short of the Kinrix. The reporter consented to follow up.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to a patient 3 years of age catch up the series of Dtap IPV; Inappropriate schedule of vaccine administered; 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 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTap IPV (received  two previous doses on an unknown date).   On 23rd April 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of 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 details were reported as follows: The Kinrix dose was given to the patient at 3 years of age to catch up the series of Dtap IPV, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The reporter could not read the lot number and expiration date very well. The patient was received two previous doses of DTap IPV vaccine. The reported batch number HB717 not found in sales data sheet and was corrected to HB7L7. The reporter requested follow up by post.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 18 year old female / was given the adult dose (20mcg) instead of the pediatric dose (10mcg) by accident; 18 year old female / was given the adult dose (20mcg); This case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number P4DJ5, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th March 2021, the patient received the 1st dose of Engerix B adult 20 mcg/mg and Engerix B Pre-Filled Syringe Device. On 8th March 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental 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 reported as follows: The pharmacist reported via online chat. The pharmacist reported that the patient (18 year old) received the 1st dose of the Energix-B vaccine and was given the adult dose (20 mcg) instead of the paediatric dose (10 mcg) by accident, which led to accidental overdose and adult product administered to child. The pharmacist wanted to know if we all had any more information regarding how they should go about dosing the subsequent vaccinations with the patient. The patient did not have any adverse effects since. The reporter did not consent to follow up. No other information was reported
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: first Shingrix dose 2 years ago / never received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter asked, if the patient would need just 1 dose to complete the series even though it had been so long since her first dose. The first dose was not administered at the pharmacy where the pharmacist was calling from therefore, she did not have any further information such as the exact date of administration, the lot number, or the route of administration.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: late for the second dose/first dose/October 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was late for 2nd dose of Shingrix and till the time of reporting, she did not receive it, which led to incomplete course of vaccination. No adverse events was reported. The patient identifier, lot number, expiration date and vaccination date for 1st dose was not provided. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix on Dec 26th, 2019 / has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of Shingrix adjuvant only portion of vaccine; administration of Shingrix adjuvant only portion of vaccine; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) (batch number L55HS, expiry date 10th October 2022) for prophylaxis.   On 26th April 2021, the patient received Shingrix. On 26th April 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional 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 only adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, she suspected 2 patients received only diluent because their office had more lyophilized vials of Shingrix than the vials of diluent but she had to wait to verify about exact administration with another clinician who was off work on the day of reporting. The reporter did not want to provide patient's date of birth (DOB) or initials until confirmed that Shingrix adjuvant was administered to patient. This case has been linked with US2021092592, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021092592:same reporter (patient 2 of 2)
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant portion of the Shingrix; received only the adjuvant portion of the Shingrix; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication 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, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was clinical manager. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient received only the adjuvant portion of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, 2 patients were involved and before she follows up with one of the patient to come back to office to repeat the dose, they wanted to know that if they wait 4 weeks according to IAC (Individual Accountability and Conduct) recommendations then the patient would be passed the 6 months schedule. No further details were reported. This case had been linked with case US2021092580, as reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021092580:same reporter (patient 2 of 2)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash form a band around her arm; This case was reported by a consumer via call center representative and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st March 2021, the patient received Shingrix. On 31st March 2021, less than a day after receiving Shingrix, the patient experienced rash. On 3rd April 2021, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's brother in law. The patient received a dose of Shingrix (unknown whether first or second). The reporter did not know the lot number and expiry date. The patient experienced rash form band on arm which resolved in few days. The reporter did not consent to follow up and permission to contact HCP (health care professional) not granted. This case has been linked with US2021085431, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021085431:same reporter