chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine. Still got shingles/Suspected vaccination failure; shingles in my eye!; Miserable; This case was reported by a consumer via interactive digital media and described the occurrence of 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), ophthalmic herpes zoster (serious criteria GSK medically significant) and feeling miserable. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine and still got shingles in her eye. The patient stated that miserable. The patient was treated with drops two times a day and antivirus pill every single day forever. The patient stated that oh the joy. The reporter did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Hypersensitivity
Clinical narrative: dizziness; Can allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced dizziness and allergic reaction. On an unknown date, the outcome of the dizziness and allergic reaction were unknown.   It was unknown if the reporter considered the dizziness and allergic reaction to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The reporter asked could allergic reaction such as dizziness be experienced a week after injection. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Can dizziness happen 1 week after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The reporter asked could dizziness happen 1 week after vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: I feel weak. Is this from the shot; This case was reported by a consumer via interactive digital media and described the occurrence of feelings of weakness 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 feelings of weakness. On an unknown date, the outcome of the feelings of weakness was unknown.   It was unknown if the reporter considered the feelings of weakness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-OCT-2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient feels weak and asked was this from the Shingles shot. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: feel very weak; This case was reported by a consumer via interactive digital media and described the occurrence of feelings of weakness 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 feelings of weakness. On an unknown date, the outcome of the feelings of weakness was unknown.   It was unknown if the reporter considered the feelings of weakness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got shot for Shingles. The patient felt very weak. The patient asked whether it was side effect. Additional supportive information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: I feel the pain as if I still had it, horrible; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   In January 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported it was been a year since patient had shingles. The patient already got vaccinated it was second dose.  The patient still feels the pain as if still it had, it was horrible. The patient did not want it for anyone. Additional supportive information: No follow up attempts possible as no contact information available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Your arm hurts a lot/ pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of 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: 29-OCT-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient stated that the vaccine was called Shingles and there were 2 doses, it was his/her turn on November 2 of this year. The patent stated that the arm hurts a lot, but it was worth two days of pain. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: has had an upset stomach every day since; This case was reported by a consumer via interactive digital media and described the occurrence of upset stomach in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was not recovered/not resolved.   It was unknown if the reporter considered the upset stomach to be related to Shingles vaccine and Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR158042   Additional Information: GSK Receipt Date: 29-OCT-2022. Reporter's comment: This case was reported by the reporter via interactive digital media. The reporter stated that his wife had two injection of shingles vaccine. She has had an upset stomach every day since. The reporter had also asked that for how long it would be like that. Additional supportive information: Follow-up would not possible, as no contact details were available. Since, we do not know after which dose the event is occurring, it is better to create a single case with both doses as suspect rather than assuming that the latest dose is the only suspected product or its occurring after each dose and hence, dose no. was also not mentioned for any dose.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Illness, Mobility decreased, Peripheral swelling
Clinical narrative: Sick; Run fever; Fatigue; Arm was swollen; Arm had heat; I still can't lift my arm; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 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, less than 2 weeks after receiving Shingles vaccine, the patient experienced sickness, fever, fatigue, swelling arm, extremities hot feeling of and mobility decreased. On an unknown date, the outcome of the sickness, fever, fatigue, swelling arm and extremities hot feeling of were unknown and the outcome of the mobility decreased was not recovered/not resolved.   The reporter considered the sickness, fever, fatigue, swelling arm, extremities hot feeling of and mobility decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that the shingle vaccine made him/her sick, run fever, fatigue, arm was swollen and had heat. The patient stated that 2 weeks after receiving Shingles vaccine he/she still cannot lift his/her arm and the patient stated that they wanted him/her to receive a second dose. Additional supportive information: Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sick; Run fever; Fatigue; Arm was swollen; Arm had heat; I still can't lift my arm; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 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, less than 2 weeks after receiving Shingles vaccine, the patient experienced sickness, fever, fatigue, swelling arm, extremities hot feeling of and mobility decreased. On an unknown date, the outcome of the sickness, fever, fatigue, swelling arm and extremities hot feeling of were unknown and the outcome of the mobility decreased was not recovered/not resolved.   The reporter considered the sickness, fever, fatigue, swelling arm, extremities hot feeling of and mobility decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that the shingle vaccine made him/her sick, run fever, fatigue, arm was swollen and had heat. The patient stated that 2 weeks after receiving Shingles vaccine he/she still cannot lift his/her arm and the patient stated that they wanted him/her to receive a second dose. Additional supportive information: Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Injection site is red; injection site is swollen and increasing in size; 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 (Shingles vaccine) for prophylaxis.   On 28th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine. The patient stated that after receiving Shingles vaccine he/she experienced injection site red and swollen and it was increasing in size. The patient thought the symptoms would decrease as time passed. The patient wanted to know was this symptoms concerning. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headaches almost daily; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2022, the patient received the 1st dose of Shingrix. In October 2022, less than 3 weeks after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-Oct-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had his/her first Shingrix shot and since then he/she had been experiencing headaches almost daily.  The patient asked was this common or should he/she report this to his/her doctor. 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 swelling, Injection site warmth
Clinical narrative: Red at site; Hot at site; Swelling at site; 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 28th October 2022, the patient received Shingrix. In October 2022, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingrix on Friday (the day before reporting) and still had red, hot and swelling at site after 4 days. The patient asked how long did side effects last. Additional Supportive Information: Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR158011   Additional Information: GSK Receipt Date: 30-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received both shots. The patient was asking what to do to alleviate the pain. Additional Supportive Information: The follow up would not possible, as no contact, details were available. Note: It was not confirmed after which dose event occur so blank dose number kept.; Sender's Comments:  US-GSK-US2022AMR158011:Same reporter
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headaches, daily, 2 weeks; This case was reported by a consumer via call center representative and described the occurrence of headache in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2022, the patient received the 1st dose of Shingrix. In October 2022, less than 3 weeks after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and since then he/she had been experiencing headaches almost daily. The patient stated headaches had lasted more than 2 weeks. The patient asked if this  was common or he/she should report this to doctor. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: Arm is horrible; This case was reported by a consumer via other manufacturer and described the occurrence of arm discomfort in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was unknown.   The reporter considered the arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comment: The reporter was a patient. The patient reported that she received Shingles vaccine. The patient stated that on the same day after received Shingles vaccine the patient experienced her left arm was horrible from the shingles vaccine. The reporter did consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: chills; 101 fever; tired; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills, fever and tiredness. On an unknown date, the outcome of the chills, fever and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever and tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comments:  The case was reported via interactive digital media. The patient asked as how long the side effects would last with the second dosage.  At the time of reporting, he/she had chills, fever (101) and tired. Additional Supportive Information: Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: skin has become itchy all over; This case was reported by a consumer and described the occurrence of itchy skin in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was unknown.   It was unknown if the reporter considered the itchy skin to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-Nov-2022 The patient self-reported this case. The patient stated that his/her skin had become itchy all over 4 days after receiving the Shingles vaccine. The patient asked was this normal. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itchy 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comments:  The case was reported via interactive digital media. The patient experienced itchy four days after shingles vaccine. Additional Supportive Information: Follow up would not possible, as no contact details were available.
Age: 6.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Six year-old accidentally got Bexsero; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd November 2022, unknown after receiving Bexsero and Bexsero 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: 02-NOV-2022 Reporter's Comments:  The reporter was patient's parent. The reporter reported that his/her six years-old accidentally received the Bexsero vaccine on the day of reporting.  The reporter asked as what were his risks. The reporter mentioned as his/her healthcare provider was the one who made the error. Additional supportive information: The patient received Bexsero at six years of age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at the injection site; Swelling at the injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema 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 injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: HCP mentioned that patients complained of redness and swelling at the injection site following a dose of Shingrix. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose after 6 months; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine.   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 drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient received 2nd dose of shingles vaccine after 6 months. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: I still have one more to go; arm hurt, hurt bad; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (everyone in family had shingles multiple times).   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive 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 pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got a shot a few years ago but this summer the patient visited to clinic and said he/she needed the new shot that hurt bad, his/her arm hurt for a week and patient still had one more dose to go. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-Nov-2022 Reporter's comment: The patient contracted shingles, the day after received Shingrix vaccine. The reporter agrees to follow up from GlaxoSmithKline. Additional supportive information: This was one of the 2 case reported by the same reporter. This case has been linked to the case US2022AMR160148 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR160148:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Temp over 101; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter wanted to know could the second shingles shot give a temperature over 101. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd shot a year after my first; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received a year before his/her second dose).   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 drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received his/her 2nd shot a year after his/her first dose. The patient asked was he/she protected. Additional supportive information: The patient received 2nd dose of Shingrix vaccine later than the recommended interval, which led to lengthening of vaccination schedule. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: fatigue as side effect; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue 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 fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter wanted to know how long did fatigue last as a side effect of the vaccine. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Ageusia, Asthenia, Dizziness
Clinical narrative: weak; lightheaded; no taste sensation; This case was reported by a consumer via interactive digital media and described the occurrence of weakness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2022, the patient received Shingrix. On 2nd November 2022, 1 days after receiving Shingrix, the patient experienced weakness, light headedness and taste absent. On an unknown date, the outcome of the weakness, light headedness and taste absent were not recovered/not resolved.   It was unknown if the reporter considered the weakness, light headedness and taste absent to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a Shingrix shot the day prior reporting and on the reporting day patient was weak, lightheaded and had no taste sensation. The reporter wanted to know was this normal.  Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: late for the second dose of Twnirx, first on March 31 2022; 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 male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 31st March 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-Oct-2022 Reporter's comment: The pharmacist reported on 31st October 2022 that the patient was late for the second dose of Twnirx.  No adverse event was reported . The consent to follow up was granted.  The vaccine administration facility was the same as primary reporter. There was no lot number and expiration date provided. There was only the first dose which was administrated by the patient. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Twnirx, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2021, late 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th July 2021, (batch number 2LC3P,expiry date 15th November 2022)).   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: 01-NOV-2022 Reporter's Comments:  The patient reported that she had her first dose of Shingrix on 14th July 2021 at her MD's office, but never received her second dose. The patient mentioned she intended on getting her second dose as soon as possible.  The reporter consented to follow up. Patient gave her physician information.  Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. This case was identified as duplicate of case US2022158140. All future correspondence would be added in case US2022158123, which stands as case of record for this patient and the case US2022158140 would be deleted.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope, Vomiting
Clinical narrative: fainted; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2022, the patient received the 1st dose of Shingrix. On 19th October 2022, 1 days after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant) and vomiting. On an unknown date, the outcome of the fainting and vomiting were recovered/resolved.   It was unknown if the reporter considered the fainting and vomiting to be related to Shingrix.  Additional Information: GSK Receipt Date: 01-NOV-2022  Reporter's Comment: The reporter was the patient. The next day of vaccination, the patient fainted and was vomiting. The reporter gave consent to follow up.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration of Kinrix to a 4 month-old patient; 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 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th 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 1st November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 1st November 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: 01-NOV-2022 Reporter's Comments:  A reporter called to ask for information about the administration of Kinrix to a 4 months old patient. The reporter asked for safety information and she asked how to proceed with patient vaccination. The reporter did not provide patient initials.  The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered Kinrix at 4 months of age, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: Hep A dose 1 in May2015, dose 2 not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (1st dose received on 20th May 2015 from lot number 2F559).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A 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: 02-NOV-2022 Reporter's Comment: The reporter reported that the patient did not receive the 2nd dose within the recommended timeframe. The reporter wanted to know if the patient need to start over the series. The reporter stated that the patient had a lot number 2F559 and he stated that it was a GlaxoSmithKline vaccine, but not the actual brand name of the vaccine. The lot number did not match with a GlaxoSmithKline vaccine.  The vaccine was administered at a different facility. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Insomnia, Limb injury
Clinical narrative: Developed a DVT; Injured her foot after vaccination; Difficulty sleeping at night; This case was reported by a consumer via call center representative and described the occurrence of dvt in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 20th May 2022, less than a day after receiving Shingrix, the patient experienced difficulty sleeping. On an unknown date, the patient experienced dvt (serious criteria GSK medically significant) and foot injury. The patient was treated with apixaban (Eliquis). On an unknown date, the outcome of the dvt and foot injury were unknown and the outcome of the difficulty sleeping was recovered/resolved.   It was unknown if the reporter considered the dvt, foot injury and difficulty sleeping to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment The reporter was patient. The patient reported that received Shingrix in unknown arm. The patient experienced difficulty sleeping that night stated issue resolved. On an unknown date, less than 6 months after receiving Shingrix, the patient  injured her foot after that and developed a deep vein thrombosis and was being treated with Eliquis.  Reporter did not consent to follow up.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: Kid received Havrix adult dose; Kid received Havrix adult dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 3-year-old male patient who received HAV (Havrix adult) (batch number NZ7JR, expiry date 17th June 2023) for prophylaxis.   On 31st October 2022, the patient received Havrix adult. On 31st October 2022, unknown after receiving Havrix adult, 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.   Additional Information: GSK Receipt Date: 03-NOV-2022 Reporter's Comment: The reporter was registered medical assistant. The reporter reported that, a kid received Havrix adult dose by error. The reporter consented to follow up by email. Additional Supportive Information: The reporter reported that, a kid received Havrix adult dose by error, which led to accidental overdose and adult product administered to child.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 01Aug2018, 2nd on 03Sep2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 1st August 2018).   On 3rd September 2022, the patient received the 2nd dose of Shingrix. On 3rd September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 03-NOV-2022 Reporter's Comment: The reporter reported that, patient was not immunocompromised. The reporter did not consent to follow-up. Additional Supportive Information: The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 1.33
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 30June2022, 2nd 4Nov2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 16-month-old male patient who received HAV (Havrix) (batch number 4CY9H, expiry date 28th April 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received on 30th June 2022).   On 4th November 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 4th November 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   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: 04-NOV-2022 Reporter's Comment: The reporter was a licensed practical nurse. The reporter reported that the maladministration in the patient who received 2nd dose received on 04th November 2022. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional supportive information: The patient received 2nd dose of Havrix early than recommended time frame, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2018, 2nd 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received 2nd dose in 2022. The reporter did not provide other information to the agent as reporter promptly ended the call without any further information reported. The reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 76 year old female of an unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: had tumor removed from neck (Not cancer), and emergency surgery on an unspecified date in 1992, and concurrent conditions included: cancer (on an unspecified date in 2011). The patient doesn't take any medications that affect immune system. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: unknown) dose was not reported, 1 total administered on 22-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 74 years old. No concomitant medications were reported.  On an unspecified date in OCT-2022, 2-3 weeks before reporting, at doctors office the patient tested positive for covid-19 virus test and experienced confirmed covid-19 infection (Symptoms were fever, trouble breathing and cough) and had confirmed clinical vaccination failure. The patient reported that her doctor gave her something and it went away after a week. The patient also reported that vaccine didn't worked for her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on OCT-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: This case is a duplicate of 20221102512. Additional information was received from patient on 31-OCT-2022. It was determined that Manufacturer Case Number 20221102512 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20221101642.; Sender's Comments: V0: 20221101642-confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.