chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site rash, Pain, Pyrexia
Clinical narrative: rash at the site of injection; fever (102); chills; overall body ache; headache for 24 hours; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd December 2021, the patient received the 2nd dose of Shingrix. On 22nd December 2021, less than a day after receiving Shingrix, the patient experienced fever, chills, general body pain and headache. On 3rd January 2022, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash, fever, chills and general body pain were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the injection site rash, fever, chills, general body pain and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient got vaccine and same the day the patient came down with a fever (102 degree F) chills , overall body ache, headache for 24 hours. The patient had all the side effects and 12 days later the patient had a rash at the site of injection. The patient asked if it was normal.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site rash, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 12 days after receiving Shingles vaccine, the patient experienced injection site rash, fever, chills, general body pain and headache. On an unknown date, the outcome of the injection site rash was unknown and the outcome of the fever, chills, general body pain and headache were recovered/ resolved. It was unknown if the reporter considered the injection site rash, fever, chills, general body pain and headache to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient self-reported the case. The patient got all the side effects after the vaccine. On an unknown date, less than a day after vaccination the day when patient got the vaccine, the patient came down with a fever (102 degree Fahrenheit), chills, overall body ache, headache for 24 hours. At the time of reporting patient mentioned that 12 days later the patient had a rash at the site of injection. The patient asked was this normal. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: fever blisters in corner of mouth 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of fever blister in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever blister. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the fever blister was recovered/resolved.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. After receiving Shingrix, the patient had fever blisters in corner of mouth 3 times. The patient asked if he/she should take the 2nd dose and stated that Valacyclovir almost cleared blisters.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever blister in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fever blister (had fever blisters in mouth prior to vaccine).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever blister, fever blister and fever blister. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the fever blister and fever blister were recovered/resolved and the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister, fever blister and fever blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine and experienced fever blisters in corner on mouth within 24 hours. The patient was placed on Valacyclovir but it did not clear until on medication for 3 and half weeks. The patient also experienced 2 more episodes of fever blisters weeks apart again and was on Valacyclovir for 1 to 2 weeks. The patient had fever blisters in mouth prior to vaccine but those never lasted 3 plus weeks or having another episode within a few weeks. The reporter wanted to know if he/she should get a second dose or avoid this dose. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms for a day; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received last year prior to the reporting date, refer case US2022001255).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. The reporter stated that the patient received dose of Shingrix last year and experienced flu-like symptoms for a day. The reporter did not consent to follow-up. This is 1 of 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022001254:Same reporter US-GLAXOSMITHKLINE-US2022001252:Same reporter US-GLAXOSMITHKLINE-US2022001255:Different dose, same patient
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 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 (shingrix) for prophylaxis. Previously administered products included shingrix (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of shingrix. On an unknown date, unknown after receiving shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient taking the 2nd shingrix vaccine more than 6 months after the 1st dose which led to lengthening of vaccination schedule. No contact details were reported.
Age: 73.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 73-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Concurrent medical conditions included myasthenia gravis. On 1st December 2021, the patient received the 1st dose of Menveo. On 1st December 2021, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. The patient was treated with eculizumab (Soliris). On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: This case was reported by the patient's wife. The reporter stated that the 73 year old patient received dose of Menveo, which led to inappropriate age at vaccine administration. The reporter stated that he needs a booster and it was scheduled for 26th January 2022, and asked was that the appropriate time frame or should it be 1st February 2022. The Menveo was a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. The Menveo was approved for use in persons aged 2 months through 55 years and a single booster dose of Menveo may be administered to individuals aged 15 through 55 years who were at continued risk for meningococcal disease if at least 4 years have elapsed since a prior dose of a meningococcal (serogroups A, C, Y, W-135) conjugate vaccine. The reporter stated that the patient was taking the drug Soliris and needs to get the vaccine as he was 1000 to 2000 times more likely to get meningitis. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had it three times and had two shots; I had it three times and had two shots; I had it three times and had two shots; I had it three times; I had it three times; I had it three times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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), vaccination failure (serious criteria GSK medically significant), vaccination failure (serious criteria GSK medically significant), shingles, shingles and shingles. On an unknown date, the outcome of the vaccination failure, vaccination failure, vaccination failure, shingles, shingles and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, vaccination failure, vaccination failure, shingles, shingles and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient reported that the patient had two shots of shingles vaccine and experienced shingles three times. The case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: I've gotten them even with the vaccine/Suspected vaccination failure; got them; awful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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), shingles and feels awful. On an unknown date, the outcome of the vaccination failure, shingles and feels awful were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient experienced shingles event with shingles vaccine. The patient stated that they were awful. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Have them for almost 3 weeks now I also had the vx; Have them for almost 3 weeks now; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had shingles vaccine and the patient had shingles for almost 3 weeks now  The patient stated that if he/she was grumpy with you just look over me please it was horrible just say a prayer for him/her. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2018, didnt receive 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 (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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable to this report. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked that will he/she need to repeat the first dose before receiving the booster. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure, Varicella
Clinical narrative: had the shot, still got shingles/Suspected Vaccination failure; shingles; chicken pox's; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and chickenpox. On an unknown date, the outcome of the vaccination failure, shingles and chickenpox were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and chickenpox to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's sister. The age at vaccination was not reported. The patient had the shingles shot but still got the shingles and chickenpox. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Got vaccine and 2 years later got shingles; I only got one shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and 2 years later experienced shingles. The patient stated that no one told him/her that he/she could still get it. The patient later heard that it was a 2-step vaccine and the patient only got one shot. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Got it AGAIN, and I did have the shots/Suspected vaccination failure; Got it AGAIN, 2nd time in 5 years; Ear, face, neck, back burning; Ear, face, neck, back itching; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In December 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, burning sensation and pruritus were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's sister. The age at vaccination was not reported. The patient had shingles shot. The patient had shingles again right before Christmas. The patient's ear, face, neck, back burning and itching at the same time. On the day of reporting it was starting to subside. The patient had shingles 2nd time in 5 years. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not reported. Note: In the narrative it was mentioned that the patient had shingles 2 times in 5 years. Since it is not clear if the 1st time was before or after the vaccine and considering there are no clear dates of each outbreak, only one event was coded.
Sex: U
Vaccine: HEP, HEP, HEP, HEP, HEP, HEP
Symptoms: Therapy non-responder
Clinical narrative: three doses, did not develop antibodies; three doses, did not develop antibodies; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 1st dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 1st dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder and therapy non-responder. On an unknown date, the outcome of the therapy non-responder and therapy non-responder were unknown.  Additional details were provided as follows: The age at vaccination was not reported. A nurse reported that one of her colleagues had two rounds of three doses of hepatitis B (manufacturer unknown) and did not develop protective hepatitis B antibodies after either of those two rounds.  The reporter consented to follow up. This case is 1 out of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022001258:Same reporter US-GLAXOSMITHKLINE-US2022001259:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: reaction too much severe, Gillian Barry Syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Prednisone and Antibiotics (2 speculums).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got shingles already and he/she knew the symptoms and to get in to doctor within 1 day.  The patient received Prednisone and 2 speculums of antibiotics which knocked the shingles down before weeping stage and nerve damage. After receiving Shingrix, the patient experienced Guillain Barre syndrome. The patient stated that, his/her reaction to Shingrix dose 1 was much too severe to repeat with 2nd dose with chances of more severe Guillain Barre Syndrome reaction which was worse than shingles. The patient had built up a bit of immunity because having had shingles already, plus 1 dose of Shingrix, was better than nothing, and stated get into doctors at first sign of infection. The patient's doctor stated that, shingles caught early was very treatable whereas Guillain Barre syndrome could put in hospital for weeks, sick for a year or two like his/her friend, and high chance of permanent nerve or muscle damage. The patient was that close and stated not worth chancing with 2nd dose of Shingrix. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first shot around October 28 of 2020 / second until July 16 of 2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on 28th October 2020).   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 details were provided as follows: The age at vaccination was not reported. The patient self-reported the case. The patient did not get the second until 16th July 2021.  The patient asked was that too much time between the two shots which would mean patient would need another shingles shot now. It looked like patient was protected after the second dose even though it was delayed, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine, had shingles later/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had the vaccine and had shingles years later. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not given.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got a shot. He broke out I shingles/Suspected vaccination failure; Shingles on face around his eyes; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got a shingles shot and he broke out with shingles, on his face around his eyes. They said it was good thing the patient got the shot or it would have been much worse.  The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not given.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold sores lip in a patient who received Herpes zoster (shingrix) for prophylaxis. On an unknown date, the patient received shingrix. On an unknown date, unknown after receiving shingrix, the patient experienced cold sores lip. On an unknown date, the outcome of the cold sores lip was unknown. It was unknown if the reporter considered the cold sores lip to be related to shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient self-reported the case. The patient asked if shingrix shot could cause a cold sore on lip. The patient would connect with doctor first and reach out again if they feel it was related. The follow-up would not possible as no contact details were available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was received more than one year after; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 394kF, expiry date 23rd September 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 13th October 2021, the patient received the 2nd dose of Shingrix. On 13th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter stated that the second dose was received more than one year after the initial vaccination, which led to drug dose administration interval too long. The adverse event filed as inappropriate schedule of vaccine. The reporter consented to follow up.
Age: 0.33
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flulaval given to 4 month old patient; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number L3HK9, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th December 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 28th December 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Physician reported that medical assistant administered a dose of Flulaval at the age of 4 months old patient, which led to inappropriate age at vaccine administration. Consent to follow up was granted by Email or phone number but no contact details available.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: couldn't move her hands and fingers completely; couldn't move her hands and fingers completely; This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2021 12:30, the patient received the 1st dose of Shingrix. On 2nd November 2021 13:00, 30 min after receiving Shingrix, the patient experienced mobility decreased and stiff fingers. On an unknown date, the outcome of the mobility decreased and stiff fingers were unknown.   It was unknown if the reporter considered the mobility decreased and stiff fingers to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The member of public informed she received shingrix and within 30 minutes she couldn't move her hands and fingers completely. No other details were available. The reporter did not consent to follow-up
Age: 0.42
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administration of Boostrix to a 5 month old patient; Pt was given Boostrix instead of Infanrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 57gj2, expiry date 29th May 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th December 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 28th December 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The health care professional called to report that a 5 month old patient was inadvertently administrated Boostrix which led to inappropriate age at vaccine administration and wrong vaccine administered. The patient was supposed to received Infanrix. No further events were reported.  The health care professional agreed to be contacted for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a adult male patient who received Herpes zoster (shingrix) for prophylaxis. On 29th December 2021, the patient received the 2nd dose of shingrix (intramuscular). On 30th December 2021, 1 days after receiving shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was not recovered/not resolved. It was unknown if the reporter considered the heart rate increased to be related to shingrix. Additional details were reported as follows: The reporter was the patient. Age at vaccination was not reported. The patient received a dose of shingrix in left arm stated he checked his heart rate every morning and he usually had a heart rate in the 50's. This morning (on the day of reporting) when he checked his heart rate had been running in the high 80's for hours now. The patient was referred to health care professional and was offered medical information number. The patient consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (shingrix) (batch number 333TE, expiry date 15th April 2023) for prophylaxis. Previously administered products included shingrix (1st dose received on 12th November 2018, from batch G45LN, expiry date 13th March 2019). On 30th December 2021, the patient received the 2nd dose of shingrix. On 30th December 2021, unknown after receiving shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the pharmacy Intern. Till the time of reporting, the patient did not receive the 2nd dose, which led to lengthening of vaccination schedule. The reporter consented to follow up. The health care professional gave permission for follow-up.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Aphthous ulcer, Oral pain, Petechiae
Clinical narrative: Canker sores in mouth and tongue, painful; canker sores in mouth that were painful also; red spots on Uvula and throat; This case was reported by a consumer via call center representative and described the occurrence of canker sores oral in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   The patient's past medical history included canker sore (getting often prior to menopause). Concurrent medical conditions included sore throat.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2021-2022 season. On an unknown date, 24 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced canker sores oral, oral pain and petechia. On an unknown date, the outcome of the canker sores oral, oral pain and petechia were not recovered/not resolved.   It was unknown if the reporter considered the canker sores oral, oral pain and petechia to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: The patient self-reported this case. The patient gets sore throats more often and she takes allergy pills thinking that it may be some type of drainage issue.   The patient used to get canker sores often prior to menopause. The patient received her first dose of Shingrix about 3 months ago of reporting date, it was given in right arm.   The patient also received the Flu vaccine at the same time but it was administered in the left arm.   Within 24 hours the patient developed small canker sores in her mouth that were painful but only lasted a couple of days and then went away.   Since then, the patient got red spots on her Uvula and down her throat as well as small canker sores on her tongue, that also lasts a couple of days then goes away.   The patient stated that these events come back on a regular basis.    The reporter consented to follow up. GSK note- Time to onset for cancker sore was provided as 24 hours in structured field, however the narrative it is mentioned as within 24 hours. Time to onset captured as per structured field
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Magnetic resonance imaging spinal abnormal, Pain in extremity, Spinal cord disorder
Clinical narrative: White spot on nerve going to spine, body's reaction to the serum; White spot on nerve going to spine, body's reaction to the serum; Difficulty sleeping; Arm pain, getting worse; This case was reported by a pharmacist via call center representative and described the occurrence of spinal cord disorder in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 31st December 2021, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced spinal cord disorder (serious criteria GSK medically significant), magnetic resonance imaging abnormal and difficulty sleeping. On 31st December 2021, the outcome of the pain in arm was not recovered/not resolved. On an unknown date, the outcome of the spinal cord disorder, magnetic resonance imaging abnormal and difficulty sleeping were unknown.   It was unknown if the reporter considered the spinal cord disorder, pain in arm, magnetic resonance imaging abnormal and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was unknown. The reporter stated that, the patient experienced pain in arm after 2nd Shingrix injection.  The patient saw a neurologist and had a Magnetic resonance imaging done which showed a white spot on nerve going to spine. Neurologist thought it was not from injection but patient's body's reaction to the serum. The pain was getting worse and patient was having difficulty sleeping. Neurololgist did not provide a prognosis but was waiting to see if it would resolve over time. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hepatitis b antibody negative in a 50-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, HAB (Twinrix) for prophylaxis, hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 30th October 2019, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 27th November 2019, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 2nd May 2020, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 2nd May 2020, not applicable after receiving Twinrix, Twinrix Pre-Filled Syringe Device, Twinrix and Twinrix Pre-Filled Syringe Device, not applicable after receiving Twinrix, Twinrix Pre-Filled Syringe Device, Twinrix and Twinrix Pre-Filled Syringe Device and unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced hepatitis b antibody negative and therapy non-responder. On an unknown date, the outcome of the hepatitis b antibody negative, therapy non-responder and drug dose administration interval too long were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The patient completed 3 dose series of Twinrix but the patient was not immune to hep b (titer done), which led to hepatitis B antibody negative and therapy non-responder. the patient received 3rd dose of Twinrix on 2nd May 2020, which was later than the recommended interval, which led to lengthening of vaccination schedule. The reporter asked if the patient need to start the whole series again. The reporter consented to follow up. No other details. This case has been linked to US2022000441, reported by the same reporter.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 50-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 with an associated reaction of therapy non-responder (completed 3 dose series as dose 3 in May 2nd 2020, dose 2 in Nov 27 2019 and dose 1 in Oct 30 2019, for tolerance refer case US2022000443). Concomitant products included HEPATITIS A VACCINE, HEPATITIS B VACCINE (TWINRIX). On 22nd December 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 22nd December 2021, unknown after receiving Twinrix and Twinrix 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 details were provided as follows: The age at vaccination was not reported but it could be 49 or 50 years. To the same patient, nurse administered Twinrix 2nd time 12 days apart between Dose 1 and Dose 2, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Limb discomfort, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of leg discomfort in a female patient who received Herpes zoster (shingrix) for prophylaxis. On 30th October 2021, the patient received the 1st dose of shingrix. On an unknown date, less than 3 months after receiving shingrix, the patient experienced leg discomfort, chills and fever. On an unknown date, the outcome of the leg discomfort, chills and fever were unknown. It was unknown if the reporter considered the leg discomfort, chills and fever to be related to shingrix. Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received first dose of shingrix and had a bad reaction to the vaccine. The patient had high fever, chills, and her legs were like rubber. The patient was advised by her physician assistant not to take second dose, however she inquired recommendation regarding if she should receive the second dose since she had a bad reaction to the first dose. The reporter declined to provide additional details, such as her date of birth or full address. The reporter did not consent to follow up. No additional details were provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received Herpes zoster (shingrix) for prophylaxis. Previously administered products included shingrix (1st dose received on 26th April 2021, batch number NE49X, expiry date 23rd August 2022). On an unknown date, the patient received the 2nd dose of shingrix. On an unknown date, unknown after receiving shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was a part of the GSK (GlaxoSmithKline) assistance program and received first dose of shingrix through the program. The Pharmacy has had an issue getting the second dose through the program, so the patient had not yet received the second dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered a dose of Engerix-B that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 26-day-old female patient who received HBV (Engerix B pediatric) (batch number LR537, expiry date 3rd January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2022, the patient received Engerix B pediatric 10 mcg/mg and Engerix B Pre-Filled Syringe Device. On 4th January 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter administered a dose of Engerix-B 10 mcg to the patient on 4th January 2022 that had expired on 3rd January 2022, which led to expired vaccine used. The reporter  consented to follow up with Email.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never came back for 2nd shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient got the 1st shot of Shingrix and never came back for 2nd shot., which led to incomplete course of vaccination. The reporter asked, did the patient need to start all over again. The reporter consented to follow up.