chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE information reported at this time; Nurse calling to report that a RECOMBIVAX HB pediatric dose was accidentally given to an adult patient.; This spontaneous report was received from a nurse and refers to an adult, female patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 09-MAY-2022, the patient was accidentally vaccinated with a pediatric dose (product administered to patient of inappropriate age) of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (exact dose, strength, lot #, expiration date, site and route of administration were not provided). The vaccine was stored properly and was not expired. There was no additional adverse event reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects or symptoms following administration. The vaccine had no temperature excursions. No other AE/no PQC.; Caller is a medical assistant who reports an expired dose of ROTATEQ was given to a patient today. No adverse effects or symptoms following administration. The vaccine had no temperature excursions. Dose was supported by post-expiry memo.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 13-MAY-2022, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml once, orally, lot# 1707449, expiration date reported as 28-MAR-2022,  for prophylaxis (strength was not reported) (Expired product administered). No adverse effects or symptoms following administration. The vaccine had no temperature excursions, no PQC.
Sex: U
Vaccine: HEP
Symptoms: Bell's palsy, Facial paralysis, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Bell's Palsy; Extremity Numbness; Initial Report Received on 04-May-2022 and 05-May-2022  A registered nurse reported that a 41 year-old patient (gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed Bell's palsy and extremity numbness.  Medical history was reported as newly diagnosed diabetes.  No relevant concomitant medications were reported.    On 05-Apr-2022, the patient received a dose of HEPLISAV-B (Lot # 937232, expiration date 04-Mar-2023 and NDC # not reported) in the right deltoid intramuscularly by a nurse practitioner.  On 22-Apr-2022, 17 days after having been vaccinated with HEPLISAV-B, the patient reported symptoms of photophobia, facial numbness (tingling of the mouth and then drooping) and numbness of the right lips progressing to all four extremities. The Emergency Room (ER) doctor diagnosed the patient with Bell's palsy. The treatment for Bell's palsy included steroids.  At the time of the report, the events were considered to be ongoing.   No additional information was reported.   Company Comment: Based on the temporal relationship, the events of Bell's palsy and numbness of extremities occurred 17 days after initiating the dose of HEPLISAV-B, a causal association between the events and HEPLISAV-B is possible. Risk factors include the patient's history of diabetes. The events of Bell's palsy and numbness of extremities are unlisted per HEPLISAV-B IB, Agency.; Sender's Comments: Based on the temporal relationship, the events of Bell's palsy and numbness of extremities occurred 17 days after initiating the dose of HEPLISAV-B, a causal association between the events and HEPLISAV-B is possible. Risk factors include the patient's history of diabetes. The events of Bell's palsy and numbness of extremities are unlisted per HEPLISAV-B IB, Agency.
Sex: U
Vaccine: HEP
Symptoms: Photophobia
Clinical narrative: Bell's Palsy; Extremity Numbness; Initial Report Received on 04-May-2022 and 05-May-2022  A registered nurse reported that a 41 year-old patient (gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed Bell's palsy and extremity numbness.  Medical history was reported as newly diagnosed diabetes.  No relevant concomitant medications were reported.    On 05-Apr-2022, the patient received a dose of HEPLISAV-B (Lot # 937232, expiration date 04-Mar-2023 and NDC # not reported) in the right deltoid intramuscularly by a nurse practitioner.  On 22-Apr-2022, 17 days after having been vaccinated with HEPLISAV-B, the patient reported symptoms of photophobia, facial numbness (tingling of the mouth and then drooping) and numbness of the right lips progressing to all four extremities. The Emergency Room (ER) doctor diagnosed the patient with Bell's palsy. The treatment for Bell's palsy included steroids.  At the time of the report, the events were considered to be ongoing.   No additional information was reported.   Company Comment: Based on the temporal relationship, the events of Bell's palsy and numbness of extremities occurred 17 days after initiating the dose of HEPLISAV-B, a causal association between the events and HEPLISAV-B is possible. Risk factors include the patient's history of diabetes. The events of Bell's palsy and numbness of extremities are unlisted per HEPLISAV-B IB, Agency.; Sender's Comments: Based on the temporal relationship, the events of Bell's palsy and numbness of extremities occurred 17 days after initiating the dose of HEPLISAV-B, a causal association between the events and HEPLISAV-B is possible. Risk factors include the patient's history of diabetes. The events of Bell's palsy and numbness of extremities are unlisted per HEPLISAV-B IB, Agency.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: first Shingrix shot October 2019, second one May 2022. during covid; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2019).   On 5th May 2022, the patient received the 2nd dose of Shingrix. On 5th May 2022, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 6-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that during COVID second shots were being administered over 1 year later per GlaxoSmithKline. The patient asked did he/she need to repeat in 2-6 months. Additional supportive information: The patient received 2nd dose of Shingrix vaccine later than the recommended interval due to Covid. The follow-up would not possible, as no contact, details were available. This case has been linked with case US2022AMR074991 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR074991:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: during COVID, second shots were being administered over 1 year later; This case was reported by a consumer via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patients experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 6-May-2022 Reporter's Comment: The reporter reported this case via interactive digital media. The reporter stated that during COVID, second shots were being administered over 1 year later per GlaxoSmithKline. Additional supportive information: The patients received 2nd doses of Shingrix vaccine later than the recommended interval during Covid. The follow-up would not possible, as no contact, details were available. This case has been linked with case US2022AMR074988 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR074988:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Rash macular
Clinical narrative: Painful blotch, painful spot; Red blotch; This case was reported by a consumer via call center representative and described the occurrence of pain 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 pain and red blotches. On an unknown date, the outcome of the pain and red blotches were unknown.   It was unknown if the reporter considered the pain and red blotches to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-May-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine into unknown arm and experienced painful red blotch on the same arm but not at the injection site. The patient asked was it normal to had a painful red blotch on the same arm but not at the injection site for the first dose of Shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Rash
Clinical narrative: uncomfortable rash covering thigh; severe shivers; This case was reported by a consumer via interactive digital media and described the occurrence of shivers in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th May 2022, the patient received the 2nd dose of Shingrix. On 4th May 2022, less than a day after receiving Shingrix, the patient experienced shivers. On 7th May 2022, the patient experienced rash. On an unknown date, the outcome of the shivers was unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the shivers and rash to be related to Shingrix.  Additional Information: GSK Receipt Date: 07-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was reported by the patient. The patient had the Shingrix vaccine Wednesday morning.  The patient experienced severe shivers all Wednesday night.  At the time of reporting, the patient now had an uncomfortable rash covering his/her left thigh. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Skin exfoliation
Clinical narrative: really flaky skin; ill all day; This case was reported by a consumer via interactive digital media and described the occurrence of flaking skin in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2022, the patient received the 2nd dose of Shingrix. On 7th May 2022, 1 days after receiving Shingrix, the patient experienced unwell. On 8th May 2022, the patient experienced flaking skin. On an unknown date, the outcome of the flaking skin was not recovered/not resolved and the outcome of the unwell was unknown.   It was unknown if the reporter considered the flaking skin and unwell to be related to Shingrix.  Additional Information: GSK Receipt Date: 08-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was reported by the patient. The patient had Shingrix on Friday.  The patient was ill all day Saturday and today (at the time of reporting), noticed that he/she had really flaky skin all over. The reporter wanted to know if this was normal. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site is still red, spreading; Site with intermittent sharp pain; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2022, the patient received Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-MAY-2022. Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received Shingrix vaccine on last Tuesday from day of reporting.  The patient said the site was still red with intermittent sharp pain and redness seems to be spreading. The patient asked as how could treat it.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives all over body; This case was reported by a consumer via other and described the occurrence of generalized urticaria in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized urticaria. On an unknown date, the outcome of the generalized urticaria was unknown.   It was unknown if the reporter considered the generalized urticaria to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-MAY-2022. Reporter's Comments: The reporter stated that she had second dose of Shingrix and had hives all over.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Illness, Loss of personal independence in daily activities
Clinical narrative: horrible,pounding headaches, my head was going to blow off; get sick from the headaches; couldn't do anything for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of pounding in head in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pounding in head, sickness and activities of daily living impaired. On an unknown date, the outcome of the pounding in head and sickness were not recovered/not resolved and the outcome of the activities of daily living impaired was recovered/resolved.   It was unknown if the reporter considered the pounding in head, sickness and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. Had the shingles shot that patient's head was going to blow off could not do anything for 3 days cause of the horrible, pounding headaches. Now if patient did not take something for them every 3 or sooner hours, patient literally get sick from the headaches.  The reporter asked the pharmacy guy he said people usually get the flu or were just plain sick, couldn't understand about his/her headaches. No more of them shots for him/her. Additional supportive information: Follow-up would not possible as no contact details were available. This case has been linked to the case US2022AMR076751 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076751:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Influenza
Clinical narrative: usually get the flu; plain sick; This case was reported by a consumer via interactive digital media and described the occurrence of influenza in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patients experienced influenza and sickness. On an unknown date, the outcome of the influenza and sickness were unknown.   It was unknown if the reporter considered the influenza and sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-MAY-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The pharmacy guy said people usually get the flu or are just plain sick.  Additional supportive information: Follow-up would not possible as no contact details were available. This case has been linked to the case US2022AMR076742, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076742:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: ached really badly; fever about 36 hours; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 36 hrs after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain and fever were recovered/resolved.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 8-May-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient received 1st dose in last year 2021 and have not gotten shingles. The patient ached really badly and had a fever about 36 hours after getting the vaccines, but that was it. The patient stated that if you had chickenpox, you could get shingles. The patient decided to take chances with the vaccine. The patient knew people who were not vaccinated, got shingles and still suffer from horrible nerve pain. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR076849.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076849:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: What to do if I missed the 6 month point for 2nd vx; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 10-May-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient wanted to know what to do if he or she missed the 6 month point for second Shingrix vaccine. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: What if I missed my second Shingrix vaccine?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 10-May-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient asked what if he or she missed second Shingrix vaccine. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm for 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-May-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. After receiving Shingles vaccine, the patient had sore arm for 2 days.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Swelling
Clinical narrative: redness; swelling; received dose subcutaneously; This case was reported by a nurse via sales rep and described the occurrence of erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number B257H, expiry date 26th June 2023) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema, swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the erythema, swelling and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-May-2022 Reporter's comments: The patient received 2nd dose of Shingrix subcutaneously in left arm. The patient contacted the office with redness and swelling but did not seek medical attention. The patient just called to alert the office. Additional Supportive Information: The patients received second dose subcutaneously, which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had mine 4 years ago, now a very mild case/Suspected vaccination failure; Getting over a very mild case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media.  The reporter stated that the Shingles Vaccine was must. The patient had shingles vaccine 4 years ago and he/she just getting over a very mild case of shingles. It stayed in 1 area, and did not spread. Additional Supportive Information: The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: you had the new shots,2, and still got it./suspected vaccination failure; still got it.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 11-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media.  The patient had the 2 new shingles shots, and still got shingles. That was why the patient was afraid to get more.  Additional Supportive Information: The case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory confirmation of shingles was not reported. The follow up would not possible since no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on may 2021 was not informed about a 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date in May 2021).   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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 11-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient stated he/she received shingles vaccine 1st dose and was not informed about second dose. Additional Supportive Information: The patient did not receive 2nd dose till the time of reporting which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Immune system disorder, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis. On an unknown date, the patient received Shingrix and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and immune system disorder. On an unknown date, the outcome of the vaccination failure, shingles and immune system disorder were unknown. The reporter considered the vaccination failure, shingles and immune system disorder to be related to Shingrix. Additional Information: GSK Receipt Date: 11-MAY-2022. Reporters comment: The patient self-reported the case via interactive digital media described the occurrence of suspected vaccination failure. The patient stated that, the Shingrix shot gave him/her shingles, 4 times. This combined with Covid shot had destroyed the patient's immune system. Additional supportive information: The reporter considered the shingles and immune system disorder to be related to Covid-19 vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. No follow up would be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot, still got shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. No follow up would be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suffering, had the vac for this/Suspected vaccination failure; suffering, had the vac for this; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had the shingles vaccine but still suffering from shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2 years since first shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 13-May-2022 Reporter's Comments: This case was reported by a consumer via call center representative. The reporter stated that It had been 2 years since his/her first shot. The patient asked whether he/she should get both shots now or just the second. Additional Supportive Information: The patient did not receive 2nd dose till the time of reporting which led to incomplete course of vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Dizziness, Fatigue, Injection site erythema, Vision blurred
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number tm449, expiry date 2nd June 2023) for prophylaxis. Co-suspect products included ELASOMERAN (COVID-19 VACCINE MODERNA) for prophylaxis. On 26th April 2022, the patient received the 1st dose of Shingrix and COVID-19 VACCINE MODERNA. On 26th April 2022, less than a day after receiving Shingrix, the patient experienced fatigue, light headedness and blurred vision. On an unknown date, the patient experienced injection site erythema. On 27th April 2022, the outcome of the light headedness and blurred vision were recovered/resolved. On 30th April 2022, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the fatigue, light headedness, blurred vision and injection site erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 6-May-2022. Reporter's comments: The patient received Shingrix and Moderna COVID-19 booster on same day but at somewhere else. After receiving vaccines, on the same day, the patient experienced fatigue, lightheadedness, blurred vision and redness at the injection site. She had fatigue for 4 days, lightheadedness and blurred vision for 1 day and redness for an unknown amount of time. All symptoms were resolved. The reporter did not consent to follow-up. It was unknown if the reporter considered the fatigue, light headedness, blurred vision and injection site erythema to be related to COVID-19 VACCINE MODERNA as well.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB, TDAP, VARZOS
Symptoms: Product storage error
Clinical narrative: Several  exposed to temp below freezing (negative) -1.8 C since October 19th; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Herpes zoster (Shingrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Havrix, Bexsero, Bexsero Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Shingrix, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device and Engerix B. On an unknown date, unknown after receiving Havrix, Bexsero, Bexsero Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Shingrix, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device and Engerix B, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 9-May-2022 Reporter's comments: The reporter stated that, several vaccines were exposed to temperature below freezing negative 1.8 C since 19th October 2022 and were administered to several patients during several days. It was not confirmed if all vaccines were administered. The reporter consented to follow up. Additional Supportive Information: The patients received incorrectly stored vaccine, which led to product storage error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: on May 4th 2022 accidentally administered an expired dose to a patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva520A, expiry date 30th April 2022) for prophylaxis.   On 4th May 2022, the patient received Menveo. On 4th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 9-May-2022 Reporter's comments: Registered nurse accidentally administered an expired dose of Menveo to the patient. The reporter consented to follow up. Additional Supportive Information: The patients received vaccine post its expiry date, which led to expired vaccine used.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administered to a 6 year old child; Administered to a 6 year old child; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33AT7, expiry date 7th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th May 2022, the patient received Boostrix .5 ml and Boostrix Pre-Filled Syringe Device. On 9th May 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and adult product administered to child. On an unknown date, the outcome of the wrong vaccine administered 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 Information: GSK Receipt Date: 9-May-2022 Additional Supportive Information: The 6 year old patient was administered with Boostrix, which led to wrong vaccine administered and adult product administered to child.
Age: 16.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Administered a dose reconstituted with the MMR vaccine diluent; Administered a dose reconstituted with the MMR vaccine diluent; This case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA646, expiry date unknown) for prophylaxis.   Co-suspect products included MMR (MMR vaccine) for prophylaxis.   On 6th May 2022, the patient received Menveo and MMR vaccine. On 6th May 2022, unknown after receiving Menveo and MMR vaccine, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 9-May-2022 Reporter's comments: The reporter consented to follow up. Additional Supportive Information: The patient was administered a dose of Menveo reconstituted with the MMR vaccine diluent, which led to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received a pediatric dose of Engerix-B; Adult patient received a pediatric dose of Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 57-year-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 28th April 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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: GSK Receipt Date: 10-May-2022 Reporter's comments: The reporter consented to follow up.  Additional Supportive Information: The adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 0.67
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered Kinrix to a 8 month old; 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 8-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 21st April 2022, 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 Information: GSK Receipt Date: 10-May-2022 Reporter's comments: Clinical Assistant inquired about any information available about the administered dose was okay. They inadvertently administered Kinrix to a 8 month old patient. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Kinrix dose inadvertently, which led to inappropriate age at vaccine administration.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Some of the vaccine squirted out; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 1-year-old male patient who received HAV (Havrix) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   On 9th May 2022, the patient received Havrix. On 9th May 2022, unknown after receiving Havrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 10-MAY-2022 Reporters comment: While administering Havrix vaccine to the patient, some of the vaccine squirted out. The patient received Havrix in left thigh. The reporter consented to follow up. Additional supportive information: While administering Havrix vaccine to the patient, some of the vaccine squirted out, which led to incomplete dose administered.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles after completing series/Suspected Vaccination failure; shingles, lower spine; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 2nd dose of Shingrix. In October 2019, the patient received 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) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 10-MAY-2022 Reporters comment: The patient self-reported the case and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient was continuing to experience outbreaks of mild cases of Shingles. The patient reported outbreak was always around their lower spine and the most recent outbreak occurred at the beginning of March of the year of reporting.  The patient reported taking antivirals to treat outbreak, with good success. The reporter did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose  in November 2021, late for 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose in November 2021 ).   On an unknown date, the patient did not receive the 2nd dose of 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 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 Information: GSK Receipt Date: 10-MAY-2022 Reporter's comment: A pharmacist reported that the patient was late for the 2nd dose. The health care professional was working from home and did not have patient date of birth or vaccination date and information available at the time of report. The health care professional declined to have his information stored in GlaxoSmithKline database but did consent to follow-up via postal mail. Additional supportive information:  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult received pediatric dose; adult received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 63-year-old patient who received HBV (Engerix B pediatric) (batch number MB744, expiry date 1st March 2024) for prophylaxis.   On 9th May 2022, the patient received the 3rd dose of Engerix B pediatric. On 9th May 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 10-MAY-2022 Reporter's comment: The health care professional reported that adult patient received pediatric dose of Engerix-B. The reporter consented to follow up. No other details of patient could be provided.  Additional supportive information: The adult patients received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. This case had been linked to the case US2022076273 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022076273:same reporter